epublications.uef.fi · DISSERTATIONS | MERJA SAHLSTRÖM | PATIENT PARTICIPATION IN PROMOTING PATIENT SAFETY... | N o 495 uef.fi PUBLICATIONS OF THE UNIVERSITY OF EASTERN FINLAND

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PUBLICATIONS OF THE UNIVERSITY OF EASTERN FINLAND

Dissertations in Health Sciences

ISBN 978-952-61-2960-0ISSN 1798-5706



MERJA SAHLSTRÖM

PATIENT PARTICIPATION IN PROMOTING PATIENT SAFETY - FINNISH PATIENTS’ AND

PATIENT SAFETY EXPERTS’ VIEWS

This study explores patient participation in

the promotion of patient safety using patient-reported patient safety incident reports, patient

safety experts’ views of patient participation and patients’ experiences of safety during their

most recent period of care. Patients’ views of patient safety are generally positive, but the level of patient participation varies among organizations. Patients report diverse types and severities of patient safety incidents, but only few of their reports lead to development

measures in healthcare organizations.

MERJA SAHLSTRÖM

30959335_UEF_Vaitoskirja_NO_495_Merja_Sahlstrom_Terveystiede_kansi_18_11_21.indd 1 21.11.2018 11.19.03

Patient participation in promoting patient safety - Finnish patients’ and patient safety

experts’ views

MERJA SAHLSTRÖM

Patient participation in promoting patient safety - Finnish patients’ and patient safety

experts’ views

To be presented by permission of the Faculty of Health Sciences, University of Eastern Finland for public examination in Mediteknia MD100 Auditorium, Kuopio,

on Friday, January 11th 2019, at 12 noon

Publications of the University of Eastern Finland Dissertations in Health Sciences

Number 495

Department of Nursing Science, Faculty of Health Sciences,

University of Eastern Finland Kuopio

2019

Grano Oy Jyväskylä, 2018

Series Editors:

Professor Tomi Laitinen, M.D., Ph.D. Institute of Clinical Medicine, Clinical Physiology and Nuclear Medicine

Faculty of Health Sciences

Professor Kai Kaarniranta, M.D., Ph.D. Institute of Clinical Medicine, Ophthalmology


Associate Professor Tarja Kvist, Ph.D. Department of Nursing Science


Associate Professor (Tenure Track) Tarja Malm, Ph.D. A.I. Virtanen Institute for Molecular Sciences


Lecturer Veli-Pekka Ranta, Ph.D. (pharmacy) School of Pharmacy


Distributor: University of Eastern Finland

Kuopio Campus Library P.O.Box 1627

FI-70211 Kuopio, Finland http://www.uef.fi/kirjasto

ISBN (print): 978-952-61-2960-0 ISBN (pdf): 978-952-61-2961-7

ISSN (print): 1798-5706 ISSN (pdf): 1798-5714

ISSN-L: 1798-5706

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Author’s address: Department of Nursing Science University of Eastern Finland KUOPIO FINLAND

Supervisors: Professor Hannele Turunen, Ph.D., RN

Department of Nursing Science University of Eastern Finland Kuopio University Hospital KUOPIO FINLAND University Lecturer Pirjo Partanen, Ph.D., RN Department of Nursing Science University of Eastern Finland KUOPIO FINLAND

Reviewers: Professor Maria Kääriäinen, Ph.D. Research Unit of Nursing Science and Health Management University of Oulu OULU FINLAND

Professor Riitta Suhonen, Ph.D., FEANS Department of Nursing Science University of Turku TURKU FINLAND

Opponent: Professor Marja Kaunonen, Ph.D.

School of Health Sciences University of Tampere TAMPERE FINLAND

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Sahlström, Merja Patient participation in promoting patient safety - Finnish patients’ and patient safety experts’ views University of Eastern Finland, Faculty of Health Sciences Publications of the University of Eastern Finland. Dissertations in Health Sciences Number 495. 2019. 72 p. ISBN (print): 978-952-61-2960-0 ISBN (pdf): 978-952-61-2961-7 ISSN (print): 1798-5706 ISSN (pdf): 1798-5714 ISSN-L: 1798-5706 ABSTRACT: The purpose of this study was to describe and explain the patients' and patient safety experts’ views of patient safety and patient participation in the promotion of patient safety. The aim was to produce new knowledge of the patient's participation in the promotion of patient safety and factors influencing it. Patients' participation was studied from the point of patients’ (sub-studies I-III), and patient safety experts’ (sub-study IV) views.

Sub-study I described inpatient and day surgery patients’ (n=175) views of patient safety during their most recent period of care. The data were collected in 2011 using the Patients' Experiences of Patient Safety (PEPS) questionnaire and analysed with statistical methods. Sub-Study II descriped internal medicine patients’ (n=462) views of patient safety. Data were collected in 2015 from all five Finnish university hospitals using PEPS questionnaire. Data were analysed using statistical methods, including principal component analysis and linear regression analysis. Sub-Study III analysed patient safety incident reports (n=656) voluntarily filed by patients in 15 organizations in Finland between the years 2009-2015. The data were analysed using inductive content analysis and statistical methods. Sub-study IV was conducted to explore Finnish patient safety experts’ (n=21) views of patients’ role in promoting patient safety in 2014. Data were collected with an electronic questionnaire and interviews and analysed using inductive qualitative content analysis.

Patients felt safe during their care period and most of them evaluated the level of patient safety as very good or excellent, although 21.9% of them rated it lower. Patient safety experts were more critical and considered patient safety to be primarily at acceptable (average) level. The level of patient participation varied among organizations. Explaining factors for better patient participation included positive views of patients on the safety of medical treatment, encouragement and information provision by staff in an understandable and timely manner as well as the ability of patients to recognize patient safety incidents. Patient-related factors (e.g age, vocation, or gender) did not explain increased participation in patient safety as adequately as healthcare-related factors (e.g encouragement, and providing patients with necessary information promptly and comprehensibly). However, patients reported not to receive enough support and encouragement from healthcare workers to participate in promoting patient safety while in hospital.

Patients reported different types and severity of patient safety incidents, most commonly related to information flow and medication, and suggested practical and feasible systems-based solutions to prevent recurrence of similar types of incidents. Only 6% of those suggestions had led to actual implementation of corrective actions in the healthcare organizations. Patient safety experts considered the role of patients as an extremely important part of the promotion of patient safety, but stated that it has not reached the level demanded by the current laws and strategies.

Patients could be significantly more involved in promoting patient safety. However, there is need to create environment where patient participation is valued and it must be created with co-operation with leaders, healthcare workers and patients. Patients should be seen as experts in their own care with their will and capabilities, and the information provided by them used systematically in the promotion and management of patient safety. National Library of Medicine Classification: WX185 Medical Subject Headings: Patient Safety; Patient Participation; Patient Care; Hospitals; Surveys and Questionnaires; Finland

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Sahlström, Merja Patient participation in promoting patient safety - Finnish patients’ and patient safety experts’ views Itä-Suomen yliopisto, terveystieteiden tiedekunta Publications of the University of Eastern Finland. Dissertations in Health Sciences Numero 495. 2019. 72 s. ISBN (print): 978-952-61-2960-0 ISBN (pdf): 978-952-61-2961-7 ISSN (print): 1798-5706 ISSN (pdf): 1798-5714 ISSN-L: 1798-5706 TIIVISTELMÄ Tämän tutkimuksen tarkoituksena oli kuvata ja selittää potilaiden ja potilasturvallisuusasiantuntijoiden kokemuksia potilasturvallisuudesta ja potilaiden osallistumisesta turvallisen hoidon edistämiseen. Tavoitteena oli tuottaa uutta tietoa potilaan osallistumisesta turvallisen hoidon edistämiseen ja siihen vaikuttavista tekijöistä. Potilaan osallistumista tutkittiin sekä potilaiden (osa-tutkimukset I-III) että potilasturvallisuusasiantuntijoiden (osa-tutkimus IV) näkökulmista.

Osatutkimuksessa I kuvailtiin vuodeosasto-, ja päiväkirurgia potilaiden kokemuksia (n=175) potilasturvallisuudesta heidän viimeisimmällä hoitojaksolla. Aineisto kerättiin vuonna 2011 Patient Experiences of Patient Safety (PEPS) kyselylomakkeella ja analysoitiin tilastollisesti. Osa-tutkimuksessa II kuvailtiin sisätautipotilaiden (n=462) kokemuksia potilasturvallisuudesta. Aineisto kerättiin vuonna 2015 PEPS kyselylomakkeella kaikista Suomen yliopistosairaaloista ja analysoitiin tilastollisesti käyttäen mm. pääkomponentti- ja lineaarista regressio analyysiä. Osatutkimuksessa III analysoitiin potilaiden vapaaehtoisesti raportoimia vaaratapahtumailmoituksia (n=656), jotka oli tehty 15 organisaatioon Suomessa vuosina 2009–2015. Aineisto analysoitiin induktiivisella sisällön analyysillä sekä tilastollisesti. Osatutkimus IV kuvasi suomalaisten potilasturvallisuusasiantuntijoiden (n=21) näkemyksiä potilaan roolista turvallisen hoidon edistäjänä. Aineisto kerättiin vuonna 2014 elektronisella kyselyllä sekä haastatteluin ja analysoitiin induktiivisella sisällön analyysillä.

Tulosten mukaan potilaat tunsivat olonsa turvalliseksi hoidossa olleessaan ja suurin osa heistä arvioi potilasturvallisuuden tason olevan erittäin hyvä tai erinomainen, joskin 21,9 % arvioi sen olevan huonompi. Potilasturvallisuusasiantuntijat olivat kriittisempiä ja arvoivat tason olevan pääosin hyväksyttävällä tasolla. Potilaiden osallistumisen taso vaihteli organisaatioittain ja selittävinä tekijöinä paremmalle potilaan osallistumiselle olivat potilaiden positiiviset kokemukset lääkehoidon turvallisuudesta, henkilökunnan rohkaisusta ja tiedon antamisesta ymmärrettävällä ja oikea-aikaisella tavalla sekä potilaiden kyvyistä tunnistaa vaaratapahtumia. Potilaisiin liittyvät tekijät (ikä, sukupuoli, ammatti) ei selittänyt parempaa osallistumista niin hyvin kuin henkilökuntaan liittyvät tekijät (rohkaisu, tiedon antaminena ymmärrettävällä ja oikea-aikaisella tavalla). Tutkimuksesta selvisi, etteivät potilaat kuitenkaan saa riittävästi tukea ja rohkaisua henkilökunnalta osallistuakseen turvallisen hoidon edistämiseen sairaalassa.

Potilaat raportoivat erityyppisiä ja vakavuudeltaa erilaisia vaaratilanteita, yleisimmin liittyen tiedonkulkuun ja lääkitykseen ja ehdottivat käytännöllisiä ja systeemilähtöisiä ratkaisuja niiden toistutumisen estämiseen. Vain 6% niistä oli johtanut kehittämistoimenpiteisiin organisaatioissa. Potilasturvallisuuden asiantuntijat pitivät potilaiden roolia erittäin tärkeänä turvallisuuden edistämisessä, mutta totesivat, ettei se ole saavuttanut nykyisten lakien ja strategioiden vaatimaa tasoa.

Potilaat voisivat osallistua merkittävästi enemmän turvallisen hoidon edistämiseen. Ympäristö, jossa potilaan osallistuminen mahdollistuu ja jossa sitä arvostetaan ja tuetaan, on luotava yhteistyössä johtajien, terveydenhuollon työntekijöiden ja potilaiden kanssa. Potilaat tulisi nähdä oman hoitonsa asiantuntijoina heidän tahtonsa ja kykynsä mukaisesti. Heidän antamiaan tietoja tulisi käyttää systemaattisesti turvallisen hoidon edistämisessä sekä johtamisessa. Luokitus: WX185 Yleinen Suomalainen asiasanasto: potilasturvallisuus; potilaan osallistuminen; potilaat; hoito; sairaalat; kyseltytutkimus; rekisteritutkimus; Suomi

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Artolle, Julialle ja Jonnalle

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Acknowledgements

This study was conducted at the Department of Nursing Science at the University of Eastern Finland, department of Nursing Science, in the doctoral programme of Nursing Science. This interesting journey began in 2012 and it has been unique opportunity to meet and collaborate with numerous interesting professionals and colleques in different contexts and countries. Now it is time to express my sincere gratitude to all of you who have supported and accompanied me in different way during my doctoral studies.

First and foremost, I would like to thank my principal supervisor, Professor Hannele Turunen. You have provided me guidance, time and encouraged me at every step of this research process. You have shared moments of joy and success with me, but also challenged me to think independently, and thus supported me in widening my perspective. I am grateful of that. I owe my sincere thanks to my second supervisor University Lecturer Pirjo Partanen. You have guided me and had time for me whenever I needed. Thank you for that. You both have believed in me and kept me going with your encouragement and support even during my occasional moments of self‐doubt, giving me hope and thus helped to make this dream come true.

I am very grateful to the official reviewers Professor Riitta Suhonen and Professor Maria Kääriäinen for spending their precious time reading my thesis and their valuable comments which helped me to improve the final version of this dissertation. I would also like to sincerely thank Professor Marja Kaunonen for promising to act as my Opponent.

I would particularly like to thank Statistician Tuomas Selander, MSc, for offering his expertise in statistics, Jarkko Wallenius for his help during data collection from HaiPro database, and The Finnish Society for Patient Safety for its help during the patient safety expert data collection.

This study was financially supported by University of Eastern Finland, the Research Committee of the Kuopio University Hospital Catchment Area for the State Research Funding, the Finnish Nurse Association and The Finnish Association of Nursing Research, to which I am deeply grateful. In addition, I would like to thank my working organization, Ylä‐Savo SOTE Joint Municipal Authority, for enabling to study full time, when it was necessary to promote studies.

One of the most memorable things, during this journey, was summer schools in France, Spain and Germany hosted by the European Academy of Nursing Science (EANS). During those summer schools I met PhD students and excellent teachers all over the Europe. I want to express my warm thanks for memorable times and peer support to you all ‐ hope our paths cross sometimes again.

I wish to thank my fellow students and “adopted sisters in life” – Mari Liukka and Tuija Ylitörmänen– for their friendship and peer support. With you I can be myself, nothing more nothing less.

I want to express my warm thanks to patient safety experts with whom I have had worked closely in the past few years. We have had many fruitful conversations and we have shared our knowledge about patient safety to each other, sometimes even in the middle of the night with the glass of wine. It’s been a privilege working with you and being friends with you after those years.

I thank all my dear friends, especially Sari, Jyrki, Mira, Petri, Kirsi, Tero, Marjo and Juha for their friendship, support, delicacies, sparkling wine, enjoyable company, sharing all the precious moments in life and giving me other things to think outside my scientific work. Thank you for being you.

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I owe my warm and deepest grateful thanks to my parents for all the support and encouragements in all my pursuits. You taught me that everything is achievable if I am willing to work for it. There is no way I could thank you enough.

Most of all, I owe the deepest possible love to my family. My two delightful daughters Julia and Jonna – Thank you for all the love and joy you bring to my life. You remind me every day of what is really important in life. You make it all worthwhile ‐ Love you so much!

Finally, my beloved husband, Arto. Together we have been living through the very busy years between the hard work and family life with support to each other. I owe you the deepest and most sincere thanks for your endless love and belief in me. You lifted me up over and over again when I felt down and stressed. You just found the right words when I needed them. I am fortunate and grateful for having you beside me – you are my best friend and my true love. Thank you.

In Marjahaka, November 2018

Merja Sahlström

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List of the original publications

This dissertation is based on the following original publications:

I Sahlström M, Partanen P and Turunen H. Safety as Experienced by Patients Themselves: A Finnish Survey of the Most Recent Period of Care. Research in Nursing & Health 37: 194-203, 2014.

II Sahlström M, Partanen P, Rathert C and Turunen H. Patient participation in

patient safety still missing: Patient safety experts’ views. International Journal of Nursing Practise 22: 461-469, 2016.

III Sahlström M, Partanen P and Turunen H. Patient-reported experiences of patient

safety incidents need to be utilized more systematically in promoting safe care. International Journal for Quality in Health Care, https://doi.org/10.1093/intqhc/mzy074.

IV Sahlström M, Partanen P, Azimirad M, Selander T and Turunen H. Patient

participation in patient safety - an exploration of promoting factors. Journal of Nursing Management, doi:10.1111/jonm.12651

The publications were adapted with the permission of the copyright owners.

In addition, this summary includes previously unpublished material.

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Contents

1 INTRODUCTION……………………………………………………………………….. 1 2 PATIENT PARTICIPATION IN PROMOTION OF PATIENT SAFETY……….. 3

2.1 Patient safety ................................................................................................. 3 2.2 Literature search ........................................................................................... 5 2.3 Patient participation in promoting patient safety ................................... 6

2.3.1 Patient safety from patients’ perspectives ....................................... 6 2.3.2 Definitions of patient participation ................................................... 6 2.3.3 Models for patient participation ........................................................ 9

2.4 Factors that influence patient participation in patient safety .............. 10 2.4.1 Patient-related factors ....................................................................... 11 2.4.2 Healthcare worker-related factors .................................................. 13 2.4.3 Organizational and society-related factors .................................... 14

2.5 Strategies and methods for promoting patient participation in patient safety……. ............................................................................................ 15

2.5.1 Providing feedback ............................................................................ 16 2.5.2 Planning improvement ..................................................................... 17 2.5.3 Safeguarding individual wellbeing ................................................ 17

2.6 Effectiveness of interventions to promote patient participation in patient safety… ................................................................................................. 19 2.7 Summary of the theoretical study background ..................................... 21

3 PURPOSE AND RESEARCH QUESTIONS OF THE STUDY…………………….. 23 4 METHODS……………………………………………………………………………….. 24

4.1 Design .......................................................................................................... 24 4.2 Surveys of patients’ views of patient safety (sub-study I and II) ........ 25

4.2.1 Development and validity and reliability of the PEPS instrument ......................................................................................... 25 4.2.2 Samples, data collections and data analysis .................................. 27

4.3 Patient-reported patient safety incidents (sub-study III) ..................... 28 4.4.1 Sample, data collection ..................................................................... 28 4.4.2 Data analysis ...................................................................................... 28

4.5 Survey of patient safety experts (sub-study IV) .................................... 29 4.5.1 Sample and data collection ............................................................... 29 4.5.2 Data analysis ...................................................................................... 29

4.6 Ethical issues ............................................................................................... 30 5 RESULTS………………………………………………………………………………….. 31

5.1 Patients’ views regarding patient safety and participation ................. 31 5.2 Factors influencing internal medicine patients’ participation in promoting patient safety ............................................................................. 37

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5.3 Patient-reported patient safety incidents and their utilization in healthcare organizations ............................................................................. 38 5.4 Patient safety experts’ views of patient participation ........................... 40 5.3 Summary of the study results .................................................................. 42

6 DISCUSSION…………………………………………………………………………….. 44

6.1 Discussion of the study results ................................................................ 44 6.1.1 Patients need constant support and encouragement from healthcare workers ..................................................................................... 44 6.1.2 Underutilization of patient-reported patient safety incident data in healthcare organizations .............................................................. 46 6.1.3 Patient safety experts highlighted the patients’ role in promoting patient safety ........................................................................... 49

6.2 Discussion of the limitations and strengths of the study ..................... 50 7 CONCLUSIONS AND RECOMMENDATIONS……………………………………. 52 8 REFERENCES…………………………………………………………………………….. 54 APPENDICES ORIGINAL PUBLICATIONS (I-IV)

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Abbreviations

ACSQHC Australian Commission on Safety and Quality in Health Care

BMA British Medical Association

CINAL Cumulative Index to Nursing and Allied Health Literature

CTI Care Transitions intervention

EMPATHiE Empowering patients in the management of chronic diseases -project

EPF European Patients’ Forum

EU European Union

HaiPro Sosiaali- ja terveydenhuollon vaaratapahtumien raportointijärjestelmä, Finnish safety incident reporting database

HCO Health Care Organization(s)

HCW Health Care Worker

IOM Institute of Medicine (nowadays as NASEM= National Academies of Sciences, Engineering, and Medicine)

MRC Medical Research Council

MSAH Ministry of Social Affairs and Health in Finland

NHS National Health Service in England

NPSF National Patient Safety Foundation

OHA Ontario Hospital Association

PFPS Patients for Patient Safety -programme

PEPS Patients Experiences of Patient Safety –questionnaire

PSE Patient Safety Experts

PSI Patient Safety Incidents

PUBMED United States National Library of Medicine

TPB Theory of Planned Behavior

WHO World Health Organization

WMA World Medical Association

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1 Introduction

Nearly 18 years ago a report by the IOM—US Institute of Medicine (2000)—entitled “To Err Is Human”, triggered widespread efforts to improve patient safety. Nevertheless, one of the most challenging and pressing issues facing healthcare practitioners, managers and policy makers globally is how best to achieve this goal. Good results have been gained, for example, more than 80% reductions in central line-associated bloodstream infection (CLABSI) in intensive care units (ICU), and reductions in patient mortality (Provonost et al. 2016, Wise et al. 2013). However, despite the substantial and concentrated efforts that followed the IOM´s report, progress towards raising the safety of care for patients has been much slower than anticipated (NPSF 2015, Vincent & Almaberti 2015) and many patients still suffer from preventable harm during healthcare in hospitals (de Vries et al. 2008, Kohn et al. 2000, Nunõ et al. 2015, O´Hara et al. 2018, Rafter et al. 2017, Walton et al. 2017).

The reasons for this are manifold. Our understanding of patient safety has broadened, so broader problems that may cause significant harm to patients of all ages are recognized in all healthcare fields and settings (NPSF 2015, Vincent & Almalberti 2015). Similarly, we have broader understanding that improving patient safety demands complex system-wide efforts, involving diverse actions in performance improvement, environmental safety and risk management, including infection control, safe use of medicines, device safety, safe clinical practice and maintenance of safe care environments (World Alliance for Patient Safety 2005). Understanding that new ways of thinking and acting, together with openness to new ways of working, is needed to create highly reliable organizations has also increased (Baker 2015).

During this process, patients' roles have developed from passive recipients of care to more active and informed co-producers of health (WHO 2013). Accordingly, in recent years, the need to recognize patient's perspectives, listen to their voices, and encourage their participation in promotion of patient safety has been increasingly incorporated in policies, laws, and various programs (e.g. ACSQHC 2013, Department of Health 2015, Francis 2013, MSAH 2010, 2011, PFPS). However, the development of patient safety has largely focused on the knowledge produced by healthcare professionals, and patients are often referred to as “the most underused resource” for improving the quality, safety and efficiency of healthcare (EFP 2016, Illingworth 2015). Further, despite the potential for involving patients in promoting their own and others’ safety (Ocloo & Matthews 2016, Peat et al. 2010, Sutton et al. 2015) it has often been commented that one of the main obstacles for the patient safety movement has been the lack of patient perspectives (de Silva 2013, Feeley 2017, Vincent et al. 2017). Patients are present in every step of their care journey, giving them unique insights regarding services that address their needs and preferences (Baker 2014, Fancott 2013, Lawton et al. 2015, O´Hara et al. 2018, Pomey et al. 2015, Ringdal et al. 2017, Stanley & Doherty 2016, Wright et al. 2016), but also of the system's performance and quality of patients’ encounters (Kanerva 2015, Schildmeijer et al. 2018).

Partly due to new mindsets and increasing healthcare complexity, diverse perspectives including patients’ views as well as healthcare professionals’ and organizational leaders’ views are required for efficient identification of effective interventions to promote patient safety (Doyle et al. 2013, Lang et al. 2016, Lawton & Armitage 2012, Lawton et al. 2015). This trend is also reflected in increasing frequencies of patient participation in developing safety procedures for their care, and the promotion of patient safety in healthcare (NHS 2016). Patients are also more knowledgeable and informed than previously (Vincent & Amalberti 2015) and they accept greater participation (Ricci-Cabello et al. 2017). However,

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there is no clear evidence of the effectiveness of interventions on patient participation in patient safety and further study is needed (Berger et al. 2014, Hall et al. 2010, Peat et al. 2010, Sutton et al. 2015, Wright et al. 2016), especially from patients’ perspectives (Flink et al. 2012ab, Harrison et al. 2015, Severinsson & Holm 2015, Vaismoradi et al. 2015).

In Finland, the first national patient safety strategy was published in 2009 and clauses regarding patient safety were subsequently included in the National Health Care Act (MSAH 2010) and the Decree of the Quality of Care and Patient Safety (MSAH 2011) was adjusted accordingly. These legislative documents stipulated that patient safety improvement and promotion of patient participation should be core concerns of healthcare organizations, and key elements of their development efforts. In addition, the recently updated Finnish Patient and Client safety strategy for the years 2017-2021 highlights improvement in patients’ and clients’ active participation as one of most important healthcare goals in Finland (MSAH 2017b). These principles are also at the heart of a social- and health-care reform that is being prepared in Finland. In addition, perhaps the most significant goal of the reform is to increase freedom of choices for patients. In order to achieve these participation, choice, and safe, effective and equal care goals, patients must be heard and their participation in development of the services must be enabled (Regional government, health- and social services reform 2018 http://alueuudistus.fi/en/frontpage).

There is also an urgent need to increase patients’ perspectives in healthcare safety research, as most publications have focused on healthcare professionals’ views (Guijarro et al. 2010) both nationally and internationally. In Finland, patient safety research has largely addressed issues such as technology-induced errors in electronic health records (Palojoki 2017), managing information safely in hospitals (Jylhä 2017), developing patient safety from a system perspective in specialized psychiatric care units (Kanerva 2015), organizational learning from errors (Kinnunen 2010), and patient safety culture from healthcare workers´ perspectives (Turunen et al. 2013). To the best of my knowledge patient safety has not been previously studied from either patient’s perspectives or patient participation perspectives in Finland.

Therefore, the objective of the doctoral studies this thesis is based upon was to describe and explain the patients’ and patient safety experts’ views of the patient safety and patient participation in the promoting safety care. To do so, new knowledge was produced about patients' participation in the promotion of patient safety using patient-reported patient safety incident reports, patient safety experts' views of patient participation and patients' views of safety. In addition, explanatory factors of internal patients’ participation in promoting patient safety have been identified and the relative importance of factors that influence their participation has been addressed.

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2 Patient participation in promotion of patient safety This section introduces the main concepts related to patient participation, factors that affect it, participation models and ways that patients may participate in the promotion of patient safety identified in a systematic review of peer-reviewed literature and other (less rigorously searched) relevant sources of information.

2.1 PATIENT SAFETY

Today healthcare is increasingly complex due to the wide arrays of complex procedures and processes involved, which increase the probability of error. Therefore, patient safety has been described as “more than just a clinical problem – it is a human problem, an economic problem, a system problem, a public health problem and a community problem” (WHO 2015, 8). Patient safety is also a fundamental element of quality of healthcare delivery. It can be seen as both the processes and the state that arises from actions taken to secure patients from patient safety incidents (PSIs) (WHO 2015, Yu et al. 2016). It is most often defined as freedom from accidental injury (Kohn et al. 2000) or the reduction of risk of unnecessary harm associated with healthcare to an acceptable minimum (WHO 2009a). From the patient’s perspectives it is also a right, which should guarantee patients freedom from accidental or preventable PSIs (Yu et al. 2016) and their receipt of correct, required care that will cause as little harm as possible (MSAH 2009, 2017).

Unsafe care results in additional healthcare costs, and burdens of both harm and death due to adverse events remain unacceptably high in all countries (WHO 2015, Yu et al. 2016, Zsifkovits et al. 2016). Globally, 2.9%-12.3% of hospital patients experience adverse events (Baines et al. 2013, Baines et al. 2015a, deVries et al. 2008, Kohn et al. 2000, Mayor et al. 2017, Nunõ et al. 2015, Soop et al. 2009, Rafter et al. 2017) and up to half (de Vries et al. 2008, Kohn et al. 2000, Mayor et al. 2017) or even 70% (Rafter et al. 2017, Soop et al. 2009) of these events could be prevented.

Patient safety-related adverse events are also associated with in-hospital mortality (Ahmed et al. 2015, Baines et al. 2015b, Jha et al. 2013a, Makary & Daniels 2016, Nunõ et al. 2015) and prolonged hospital length of stay (Ahmed et al. 2015, Hoogervorst-Schilp et al. 2015, Rafter et al. 2017, Ricciardi et al. 2013, Soop et al. 2009), leading to higher healthcare costs (Frontier Economics 2014, Hoogervorst-Schilp et al. 2015, Hoonhout et al. 2009, Zsifkovits et al. 2016), as well as human costs such as pain, suffering and loss of independence. In particular, internal medicine patients with chronic diseases and conditions or patients with multimorbidity (Zsifkovits et al. 2016) and polypharmacy are often exposed to several risks, including medication problems (Härkänen et al. 2015, Panagioti et al. 2015).

For several reasons, it is not clear if healthcare is safer than before, although our healthcare systems are awash with data. Perhaps most importantly, measuring and monitoring safety is challenging (Lawton et al. 2017, Vincent et al. 2013, 2014). There are multiple tools to measure safety (Global Trigger Tools, measures of patient safety culture, patient safety and quality indicators, incident reporting systems etc.), but no single measure can cover all aspects of safety (Vincent et al. 2013). Moreover, the possibility has been raised that too much information to be effectively processed is collected by, for example, incident reporting systems. Repeated reports suggest that PSIs may lead to strong safety improvements in some cases, but far too frequently there is a poor culture of learning (MacRae 2016).

To assess the safety of current care, Vincent et al. (2013) have posed the following questions: “Has the care we deliver been safe in the past? Are our systems and processes

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reliable? Is our care safe today? Will our care be safe in the future? Are we responding and improving?”. These questions highlight needs to identify potential vulnerability resources and strive to increase their flexibility, in other words to predict the risks and prepare for them (UK Improvement Alliance 2017, Vincent et al. 2013, 2014).

Current evidence on the state of patient safety is mixed. A longitudinal adverse event study even reported an increase in rates of adverse events (AEs) in The Netherlands from 4.1% in 2004 to 6.2% in 2008 (Baines et al. 2013), although a few years later it had decreased to 5.7% in 2011/2012 (Baines et al. 2015a). The preventable AE rate also decreased 30% from 2008 to 2012 (Baines et al. 2015a). However, in 2015, an expert panel convened by the National Patient Safety Foundation (NPSF) in the United States concluded that despite the mixed evidence overall healthcare is safer than in the past. They justified their views by noting that standard practices and metrics have been created, healthcare organizations have adopted high reliability theories, improvements have been made in medication safety, efforts have been made to improve culture, and patient safety now receives far greater attention from organizational leaders, patients, healthcare professionals, and policymakers (NPSF 2015).

Although improving patient safety by reducing the incidence and impact of preventable adverse events is a pressing global challenge, progress has been quite slow (Baker 2015, Francis 2013, NPSF 2015, Vincent & Almaberti 2015). This is partly because of the rapid evolution of healthcare and consequent expansion of the definition of patient safety. More types of events are being considered as safety issues, such as malnutrition, dehydration and delirium, all of which are now being viewed as safety issues after the cited report by Francis (2013). While the concept of patient safety has evolved and developed in the context of hospital care, home care has now expanded and is likely to require different concepts, approaches and solutions to those developed in the hospital settings. New technologies change healthcare, by both offering solutions and raising new risks (Wachter 2015). Moreover, the ways healthcare is organized and care is delivered have changed and will keep changing in the future, so safety is a moving target and difficult to catch (Vincent & Amalberti 2015).

Another aspect that may contribute to slow improvement is that the desired improvements in patient safety require changes in cultures within healthcare organizations (HCOs) (Kohn et al. 2000), which influence how HCOs learn (Harvey et al. 2015). How, and how effectively, HCOs learn and adopt new practices depend on their ‘absorptive’ capacity, i.e. their ability to recognize the value of new knowledge and information, assimilate it, and then apply it to make decisions and implement actions (Harvey et al. 2015), such as introduction of best practices (Innis & Berta 2016). The organizational context, which encompasses (inter alia) leadership, culture, teamwork, and resources, affects the implementation and effectiveness of measures intended to improve practices in HCOs (Harvey et al. 2015, Øvretveit 2011). These contextual factors may explain why some, but not all, organizations successfully improve performance (Harvey et al. 2015). To ensure learning, organizations need to have clearly defined learning processes, open and conversational atmospheres, systemic thinking, management commitment, support from supervisors, and systematic transfer of information (Andersson & Kodate 2015, Kinnunen 2010).

In this study patient safety refers to the quality of healthcare delivery where patients are secured from preventable PSIs and where patients receive correct, required care that will cause as little harm as possible. Patient safety includes treatment-, medication-, and device safety.

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2.2 LITERATURE SEARCH

Peer-reviewed literature published between the start of 2010 and October 2017 was systematically searched to obtain a coherent understanding of current knowledge regarding patient participation in promoting patient safety. Keywords, such as patient safety, patient participation, patient involvement, patient engagement, patient collaboration, patient empowerment, in various combinations, were used (Figure 1). Included papers had to focus on patient participation, present an empirical study or literature review, and address patient safety.

In the first stage of the selection, retrieved articles’ titles were screened for relevance and duplicates were removed. Then abstracts of retrieved articles were read, evaluated and if they were not relevant, they were removed. In the final stage of the selection, full articles were read and evaluated in their entirety. The evaluation of articles included the assurance of inclusion criteria and relevance.

To minimize the risk of missing relevant articles, a manual search of journals and of the reference lists of selected articles were captured by the initial searches. The selection process (Figure 1) resulted in 58 articles, which are described in Appendix 1.

Search terms: "patient safety" AND ("patient* participat*" OR "patient* involv*" OR "patient* engag*" OR "patient* empower'" OR “patient* collaborat*” OR "participat* patient*" OR "*involv* patient*" OR "engag* patient" OR "empower* patient*" OR “collaborat* patients* ) Limits: English language, peer-reviewed

Search terms: "patient participation" OR "patient involvement" OR "patient engagement" OR "patient empowerment" OR "patient collaboration" OR "participating patients" OR "involving patients" OR "engaging patients" OR "empowering patients" OR "collaborating patients" AND “patient safety”

Scopus 406

Cinahl 167

Pubmed 269

Cochrane 62

Total N=904

Duplications (n=469) removed

Accepted on the basis of title (n=184)

Accepted on the basis of the abstract (n= 59)

Accepted on the basis of full text (n=47)

Other relevant articles added on the basis of manual search (n=11)

Final number of articles n=58

Figure 1. Results of computerized and manual searches of the literature in patient participation in patient safety

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2.3 PATIENT PARTICIPATION IN PROMOTING PATIENT SAFETY

2.3.1 Patient safety from patients’ perspectives Patient safety is the cornerstone of high-quality healthcare, which encompasses efficiency, effectiveness, timeliness and patient experience (Vincent et al. 2013). It can also be seen as a right to freedom from preventable PSIs in medical care, which requires establishment of systems that minimize the likelihood of errors and maximize the likelihood of preventing them (Kohn et al. 2000, Yu et al. 2016). As already mentioned, it can be seen as both the processes and the state that arises from actions taken to secure patients from PSIs (Yu et al. 2016).

Patients tend to have much broader definitions of medical errors than healthcare workers (HCWs) (Burroughs et al. 2007, Davis et al. 2013a, Guijarro et al. 2010, Harrison et al. 2015, Rathert et al. 2011) and it is difficult for patients to disentangle the various dimensions of safety from quality (Rhodes et al. 2016). This is demonstrated by findings that patients most easily recognize problems that could be classified as service- and quality-related problems, e.g. lack of respect, time pressure, rudeness, breaches of confidence, long waiting times, lack of available appointments and communication failures (Lang et al. 2016, Rathert et al. 2011).

While a system approach dominates HCWs’ safety thinking, for patients safety is more personal and realized in interactions between HCWs and patients. Hence, patients have different interpretations of safety, and they can change in different healthcare contexts (Rhodes et al. 2016). Furthermore, patients define safety in physical and emotional terms. Physical safety is reportedly perceived when nurses check and monitor them (Lasiter 2011, Lovink et al. 2015, Vaismoradi et al. 2011), when they are close enough to be seen or heard (Lasiter 2011), and when they do not experience complications. Recorded feelings of safety also include being peaceful during care (Lovink et al. 2015) and perceiving nurses as qualified and likely to act in a certain way (Lasiter 2011).

Although it is estimated that about one in ten patients experience adverse events during treatment periods (Kohn et al. 2000, Nunõ et al. 2015) and medical error is the third most common cause of death in the USA (Makary & Daniel 2016), EU citizens find healthcare to be mostly high-quality and safe (Eurobarometer 2014). According to the cited Eurobarometer survey, most EU citizens rated the overall quality of healthcare in their country as good, but more than half thought that patients might be harmed by hospital care in their country. Moreover, shares of citizens thinking that patients in their country could be harmed by hospital care and non-hospital healthcare increased from 50% and 46% in 2009 to 53% and 50% in 2014, respectively (Eurobarometer 2014).

Most errors do not cause harm to patients (Howell et al. 2015, Härkänen et al. 2015, Pham et al. 2016), but approximately 1% of PSIs cause severe harm or death to patients (Howell et al. 2015, Pham et al. 2016, Ruuhilehto et al. 2011). When considering this from patients’ perspective it is even more alarming that most harm that had been classified as 'severe' or 'death' would have been avoidable or potentially avoidable (Thomas & McDonald 2016).

2.3.2 Definitions of patient participation Although patient participation is gaining international interest and is broadly supported (Johnstone & Kalitsaki 2009, NHS 2016, WHO 2013) it still seems to be a poorly defined concept (Johnstone & Kalitsaki 2009, Longtin et al. 2010, Sahlsten et al. 2008, Tobiano et al. 2015a). It is also a very complex concept (Weingart et al. 2011), entwined with social relations between patients and HCWs, the care processes (Cahill 1998, Schwappach & Wernli 2011, Weingart et al. 2011) and their feelings and views (Weingart et al. 2011). Hence, there is no clear and commonly accepted definition of patient participation (Johnstone & Kalitsaki 2009, Longtin et al. 2010, Sahlsten et al. 2008). There are also

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perspective-based variations in existing definitions. HCWs generally associate patient participation with eliciting clinically relevant information from patients, empowering them to observe and convey symptoms to the HCWs, and enabling them to comply with medical advice (Martin et al. 2013) or simply equate it with medical compliance and following doctors’ orders (Eurobarometer 2012). In contrast, for many patients, participation is a nebulous concept connected to healthy living and responsibility for one’s own health (Eurobarometer 2012). Further, Eldh et al. (2010) found that patients perceived participation as having knowledge and interaction with health professionals and participating in decision making rather than merely being informed.

Published definitions of patient participation and its synonyms are presented in Table 1. Patient participation is commonly used synonymously and interchangeably with other terms such as “patient involvement”, “patient engagement”, “patient partnership”, and “patient collaboration”, but they are often used to encompass quite different elements of participation (Cahill 1998, Eldh et al. 2010, Longtin et al. 2010, Martin et al. 2013). Some are restricted to patients’ participation in decision-making (Thesaurus of the United States National Library of Medicine), some emphasize the relationships between patients and HCWs (Sahlsten et al. 2008, Eldh et al. 2010), some highlight HCWs working together with patients (Carman et al. 2013, Coulter 2011), and some focus on processes that increase patients’ control over their health and healthcare (Emphatie 2013, WHO 2009, 2013) or benefits from healthcare services (Center for Advancing Health 2010). In the broadest terms, participation is seen as patients’ involvement in the planning, delivery, monitoring and evaluation of their own care (NHS 2013, Phillips et al. 2014). At the context of patient safety, patient participation is not defined either.

Table 1. Definitions of patient participation and related concepts Concept Definition Author Patient participation

Patient participation is “involvement in the decision-making process regarding health issues”

United States National Library of Medicine

Patient participation in nursing practice can be defined “as an established relationship between nurse and patient, a surrendering of some power or control by the nurse, shared information and knowledge, and active engagement together in intellectual and/or physical activities”

Sahlsten et al. 2008 (page 9)

A participating patient is “a resourceful individual who comprehends, i.e. has and receives information, corresponding to sharing knowledge and sharing respect.

Eldh et al. 2010 (page 28)

“Patient involvement in decision-making in advisory boards or committees at macro and meso levels of health care, but also [understood to mean] involvement at micro level in relation to: • decision-making on their own care and treatment (SDM); • administration of the treatment (compliance with prescriptions

and self-management); and • safety management through, for example, general vigilance,

participation in patient experience surveys or targeted interventions such as surgical-site marking or asking professionals about their hand hygiene.”

WHO 2013 (page 8)

Table 1 to be continued

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Table 1 continues

Patient participation is “the active involvement of the patient in planning, delivery, monitoring and evaluation of their own care”

Phillips et al. 2014 (page 68)

Patient engagement

Engagement is "actions individuals must take to obtain the greatest benefit from the health care services available to them"

Center for Advancing Health, 2010 (page 2)

Patient engagement means “engagement in one’s own health, care and treatment”

Parsons et al. 2010 (page 4)

Patients and health care providers working together to “promote and support active patient and public involvement in health and healthcare and to strengthen their influence on healthcare decisions, at both the individual and collective levels”

Coulter 2011 (page 10)

Patient and family engagement

Patient and family engagement is “patients, families, their representatives, and health professionals working in active partnership at various levels across the health care system— direct care, organizational design and governance, and policy making—to improve health and health care”

Carman et al. 2013 (page 224)

Patient and public engagement

Patient and public engagement is “the active participation of patients, carers, community representatives, community groups and the public in how services are planned, delivered and evaluated. It is broader and deeper than traditional consultation. It involves the ongoing process of developing and sustaining constructive relationships, building strong, active partnerships and holding a meaningful dialogue with stakeholders”

NHS 2013 Patient experience book (page 11)

Patient empowerment

Patient empowerment is “the process by which patients gain more control over their health and health care”

WHO 2013 (page 8)

Patient empowerment is “a process through which people gain greater control over decisions and actions affecting their health” and should be seen as both an individual and a community process.”

WHO 2009 (page 190)

An empowered patient has control over the management of their condition in daily life. They take action to improve the quality of their life and have the necessary knowledge, skills, attitudes and self-awareness to adjust their behavior and to work in partnership with others where necessary, to achieve optimal well-being.

EMPATHiE 2013 (page 6)

Patient involvement

Patient involvement means “involvement in the design, planning and delivery of primary care services”

Parsons et al. 2010 (page 4)

It refers to “the extent to which patients and their families or caregivers, whenever appropriate, participate in decisions related to their condition (e.g. through shared decision-making, self-management) and contribute to organizational learning through their specific experience as patients (e.g. patient reporting of adverse events or participation in root cause analysis related to their care)”

EPF European Patients’ Forum 2016 (page 12)


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Table 1 continues

Patient and public involvement

PPI is defined by the NHS as the “active participation of citizens, users and carers and their representatives in the development of healthcare services and as partners in their own healthcare.”

British Medical Association 2011 (page 1)

In this study, patient participation refers to patients’ involvement in planning, delivery, monitoring and evaluation in their own care as presented by Phillips et al. (2014) with focus on patient safety.

2.3.3 Models for patient participation One of the oldest, but still used, models for citizen participation is called Arnsteins’ ladder (1969): a typology of eight “rungs” of participation based on how much power citizens actually have. The lowest rungs, “manipulation” and “therapy”, are forms of "non-participation" and substitutes for genuine participation. The next level, “tokenism”, includes “informing” and “consultation”, where citizens may hear and be heard, but lack the power to ensure that their views will be heeded. Rung five, “placation”, is also a form of tokenism, but incorporates more than informing and consultation. The upper rungs (“partnership”, delegated power” and “citizen control”) lead to the highest level of participation, “citizen power”, where citizens have true power (Arnstein 1969).

However, the world has changed in the past 40 years and Arnsteins’ ladder has not avoided criticism. The model has been criticized, for instance, for failing to consider key factors in user involvement, such as some users not wanting to be involved, and for being one-dimensional, ignoring different types of involvement (Tritter & McCallum 2006). Moreover, it only considers outcomes (Tritter & McCallum 2006) although patient engagement can be seen both as a means to an end and an end in itself (Coulter 2011).

Arnstein’s ladder has influenced development of a multidimensional framework for patient and family engagement in health and healthcare, presented by Carman et al. (2013). According to this framework, involvement can vary at multiple levels, such as consultation, partnership and shared leadership, and it is based on how much information flows between patients and HCWs, activities of patients and stage(s) of patients’ involvement in decisions and policy-making (Carman et al. 2013, Ocloo & Matthews 2016). Carman et al. (2013) exemplify the continuum of engagement with the use of electronic patient records. At the lower end of the participation continuum (consultation), doctors may use the records, but patients receive required information from doctors, and have no direct access to the records. At the midpoint of the continuum (involvement) patients receive information from doctors, and have access to their medical records, but they cannot contribute or correct information. At the higher end of the continuum (partnership and shared leadership), patients have direct access to their medical records and can add or edit information when necessary. In contrast to Arnstein’s model, Carman et al. (2013) do not suggest that there should always be an intention to progress towards partnership and shared leadership, because it is not necessarily best (or even possible) for every patient. Moreover, the optimal level of participation may depend on the circumstances (Ocloo & Matthews, 2016).

In a further difference from Arnstein’s model, the framework presented by Carmen et al. (2013) recognizes that engagement can occur at levels from direct care, through organizational design and governance, to policy-making. At the direct care level, engagement can vary from patients simply receiving timely, complete, and understandable information to communicating with doctors about their health, understanding the risks and benefits associated with care choices, asking questions, and accessing and helping to create their medical records. At this level, healthcare professionals should also respect patients’

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values, beliefs and give patients encouragement and support (Carman et al. 2013). At the level of organizational design and governance, participation may involve patients planning, delivering, and evaluating care based on their values, experiences, and perspectives together with organizational leaders, managers, and clinicians. At the policy-making level, patients may develop, implement, and evaluate healthcare policies and different programs in collaboration with community leaders and policy-makers. The goal is to solve broader problems, shape healthcare policy, and set priorities for the use of resources. However, the highest engagement, partnership at this level, is still rare for patients (Carman et al. 2013).

The framework presented by Carman et al. (2013) provided foundations for another framework developed by the UK’s National Health Service (NHS). This is customized for the NHS healthcare system, includes consideration of the safety of patients’ care, safety of the service provider, and safety of the system, and is intended to facilitate increases in co-design and co-production in healthcare (Ocloo & Matthews 2016).

The NHS framework also provides examples of how patient engagement in patient safety can be achieved. Engaging patients in promoting patient safety is part of safety culture (Schwappach & Wernli 2010a) and there is still a need for broader frameworks that support not only the development of patient participation approaches and interventions, but also understanding of patient participation’s effects (Ocloo & Matthews 2016). Further, it is important to recognize that numerous factors (including diverse patient-, HCW-, organizational- and society-related variables) influence patients’ opportunities, willingness, and ability to participate as well as the level of their participation. These factors are considered in the following section.

2.4 FACTORS THAT INFLUENCE PATIENT PARTICIPATION IN PATIENT SAFETY

Patient participation requires an environment where it is valued and supported (Davis et al. 2011). In addition, promotion of patient participation needs understanding of what patient-provider encounters should be like, how they may vary among care settings (Bishop et al. 2015) and how involvement can be practiced by both parties (Martin et al. 2013). Implementing “one size fits all” intervention approaches is not enough, as multiple factors must be taken into account (Table 2). Table 2. Contrubuting factors for patient participation Findings Authors (year) Patient-related factors • Demographics (e.g. age, gender) Berger et al. 2014, Coulter & Ellins 2006, Davis et al. 2008,

Johnstone & Kalitsaki 2009, Longtin et al. 2010, Schwappach 2010, Schwappach et al. 2011b, Tobiano et al. 2015b, Tobiano et al. 2016, Waterman et al. 2006

• Patients’ willingness or ability to participate

Entwistle et al. 2010, Johnstone & Kalitsaki 2009, Peat et al. 2010, Rainey et al. 2013, Schwappach & Wernli 2010a, Tobiano et al. 2015a, Tobiano et al. 2016, WHO 2013

• Patients’ health literacy Coulter & Ellins, 2006, IOM 2004, WHO 2013 • Severity of illness and

comorbidity Longtin et al. 2010, Rainey et al. 2013

• Self-efficacy, i.e. patients’ belief in their own ability to complete tasks

Bishop et al. 2015, Davis et al. 2015, Longtin et al. 2010, Schwappach 2010, Schwappach & Wernli 2010a, Spruce 2015


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Table 2 continues • Acceptance of the new active

patient role Longtin et al. 2010

• Attention to staff workload Entwistle et al. 2010, Martin et al. 2013, Schwappach & Wernli 2011

• Relevance of required safety-related behavior

Bishop et al. 2015, Coulter & Ellins 2006, Davis et al. 2008, Davis et al. 2012, Schwappach & Wernli 2010a

• Worry about HCWs´ attitudes Berger et al. 2014, Martin et al. 2013, McDonald 2013, Seale et al. 2015

HCW-related factors • Health professionals’

encouragement to participate Entwistle et al. 2010, Longtin et al. 2010, Schwappach 2010, Bishop & McDonald 2017, Davis et al. 2013b, Davis et al. 2015, Martin et al. 2013, Tobiano et al. 2015a, Ringdal et al. 2017, WHO 2013

• Communication Eldh 2006, Drach-Zahavy & Shilman 2015, Longtin et al. 2010, Spruce 2015

• Sharing of information and power with patients

Hendersson 2003, Lawton & Armitage 2012, Longtin et al. 2010 McTier et al. 2013, Rainey et al. 2013, Tobiano et al. 2015a

• Attitudes of HCWs Birks et al. 2011, Flink et al. 2012a,b, Longtin et al. 2010 • Task-oriented behavior Drach-Zahavy & Shilman 2015, McTier et al. 2013, Rainey et al.

2013, Tobiano et al. 2015a • Time constraints Bishop & Macdonald 2017, Bucknall et al. 2015b, Longtin et al.

2010, Martin et al. 2013, Rainey et al. 2013, Schwappach & Wernli 2011, Tobiano, mcTier et al. 2013

• Difficulties with using patient-generated information

Martin et al. 2013, Rainey et al. 2013, Sutton et al. 2015

Organizational and society- related factors

• Paternalistic and hierarchical culture

Carman et al. 2013, Eurobarometer 2012, Kemper et al. 2013,

• Cultural and social attitudes Bartlova et al. 2014 • Competing priorities, a lack of a

quality improvement infrastructure, and a lack of supporting values

Coulter & Ellins 2006, Longtin et al. 2010, Martin et al. 2013, Ocloo & Matthews 2016, Sutton et al. 2015

2.4.1 Patient-related factors The extent to which patients can promote safety depends on many factors (Coulter & Ellins 2006). Patients' demographic factors have known association with patient participation (Berger et al. 2014, Coulter & Ellins 2006, Davis et al. 2008, Johnstone & Kalitsaki 2009, Longtin et al. 2010, Schwappach 2010, Schwappach et al. 2011b, Tobiano et al. 2015b, Waterman et al. 2006), for example young patients are reportedly more willing than older patients to encourage HCWs to wash their hands (Berger et al. 2014) or report safety concerns (Schwappach et al. 2011b). Some studies have also suggested that female patients (Davis et al. 2008, Schwappach 2010) and patients with higher education (Davis et al. 2008, Longtin et al. 2010) are more willing to ask HCWs questions than men and less educated patients. Patients’ feelings of being included and informed, respected for their knowledge by nursing staff (Tobiano et al. 2015a) and feeling empowered to request assistance (McInnes et al. 2014) also promote patient participation.

Patients’ state of health also affect the extent to which they are capable of or want to be involved in their own care (Entwistle et al. 2010, Johnstone & Kalitsaki 2009, Peat et al. 2010,

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Rainey et al. 2013, Schwappach & Wernli 2010b, Tobiano et al. 2015a, WHO 2013), so severity of illness and comorbidity can limit patient participation (Longtin et al. 2010, Rainey et al. 2013). Patients’ worries, perceptions of preventability of PSIs (Schwappach 2010) and capacities to obtain, process, and understand information needed to make appropriate health decisions (IOM 2004), all influence how effectively information about safety can be discussed with patients (Coulter & Ellins, 2006, WHO 2013). Similarly, patients’ trust in their own capacity to make decisions increases when they are thoroughly informed (Longtin et al. 2010, Spruce 2015) in an understandable way using plain language and avoiding medical jargon (McDonald 2013).

A factor that makes patient participation challenging is that patients’ capabilities (Tobiano et al. 2015b) and knowledge (McInnes et al. 2014, Peat et al. 2010, Schwappach & Wernli 2010b) are not constant and equal. As noted by Schwappach & Wernli (2010b), patients see participation in safety as a process requiring learning, starting from a limited knowledge base and proceeding to some level of “expert status”.

A key factor that prevents patients from speaking up about their acute illness is their inability to recognize changes not only in their clinical condition (Rainey et al. 2013) but also their vulnerability (Sutton et al. 2015). Acceptance of the new active patient role in promoting their own and others’ safety is complex and might be challenging for patients (Longtin et al. 2010). Patients can consciously choose to be active, collaborative or passive in their care, based on their preferences, but patients are unsure about how they are supposed to act, which may lead them to engage more or less in participation than they want to (Tobiano et al. 2015a). Nevertheless, patients who are very comfortable with error prevention (Waterman et al. 2006), or have perceived ability to ensure their continuity of care, are reportedly significantly more active in error-prevention actions than those who do not believe their contribution would add value to HCWs or their care (Flink et al. 2012a,b).

Patients tend to view patient participation in a content-dependent rather than uniform manner (Bishop et al. 2015, Coulter & Ellins 2006, Davis et al. 2008, Davis et al. 2012, Schwappach & Wernli 2010b). They appear less likely to participate in behaviors that require them to question doctors’ or nurses’ actions or that are unfamiliar to them (Davis et al. 2008, Davis et al. 2013b, Schwappach & Wernli 2011). Patients may have concerns that their interference in HCWs’ work could have potential ramifications for the patients and cause troubles or offence (Berger et al. 2014, Seale et al. 2015). Patients can be reluctant to ask questions during appointments with their doctors for fear of ‘second guessing’ or being perceived as difficult or contrary by their doctors (De Brún et al. 2017, McDonald 2013). Patients are also worried that more active participation in safety could have a negative influence on their treatment, i.e. that identification of errors is ‘meddling’ in the affairs of the health professionals and could therefore be a potential source of conflict. So, generally patients may assume that acquiescent patients on good terms with the health professionals are likely to receive better care than challenging and difficult patients (Martin et al. 2013). Thus, providing safety-related information to patients could generate negative emotions and beliefs by making patients nervous or undermining trust in doctors (Davis et al. 2013b). Patients have also emphasized that they consider staff workloads and risks of ‘taking time’ from patients in greater need before voicing demands or concerns (Bishop & Macdonald 2017, Entwistle et al. 2010, Martin et al. 2013, Schwappach & Wernli 2011). Thus, HCWs and patients need to have mutual understanding of what are considered appropriate questions for patients to ask, to avoid causing offence to those involved in their healthcare treatment but ensure that patients can ask challenging questions without fear (Davis et al. 2008, Entwistle et al. 2010). In these situations, HCWs’ encouragement is particularly important for patients’ involvement generally, and in patient safety specifically (Berger et al. 2014, Entwistle et al. 2010, Martin et al. 2013).

Patients' participation and the factors influencing it can also be considered in terms of Theory of Planned Behavior (TPB), which has been applied in several studies on patient

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participation in promotion of safety. Results of these studies indicate that self-efficacy (extent or strength of one's belief in one's own ability to complete tasks and reach goals), preventability of PSIs, effectiveness of actions (Bishop et al. 2015, Schwappach 2010, Schwappach & Wernli 2010a) and patients’ belief that they can influence provider behavior (Bishop et al. 2015, DeBrún et al. 2017) strongly influence patients’ intentions to participate in error prevention. Patients’ self-efficacy also influences whether they consider required behavior, how much effort they put into performing a behavior and how well they maintain a behavior (Bishop et al. 2015).

2.4.2 Healthcare worker-related factors HCWs’ encouragement is crucial for patient participation generally, and specifically in patient safety behaviors (Davis et al. 2013b, Davis et al. 2015ab, Entwistle et al. 2010, Longtin et al. 2010, Martin et al. 2013, Schwappach 2010, Tobiano et al. 2015a, WHO 2013) e.g. during handovers (Eldh et al. 2006), when speaking up about patients’ concerns (Kemper et al. 2013, Rainey et al. 2013), discussing medical errors or complications with patients, or participating in the site-marking process (Spruce 2015). For example, HCWs’ encouragement increases patients’ likelihood to ask doctors about handwashing, which is known to be challenging for patients (Davis et al. 2008, Davis et al. 2015b). HCWs’ support also increases the likelihood of patients’ initiating and engaging in care decisions (Kemper et al. 2013), and conversely lack of encouragement inhibits such patient participation (Eldh et al. 2006). However, such encouragement may rely on initiatives by individual health professionals rather than being part of organizations’ safety culture (Martin et al. 2013). HCW support also implies acceptance of patient participation and the need to encourage patient contributions and receptiveness to their input (WHO 2013). Thus, successful patient participation to reduce PSIs and improve safety requires environments where patient participation is valued and supported (Bishop & McDonald 2017, Coulter & Ellins 2006, Vaismoradi et al. 2015).

HCWs’ communication is also important for patients (Longtin et al. 2010, Spruce 2015). Using language that is either authoritative or patronizing (Longtin et al. 2010), and use of medical jargon or interrupting patients’ speech can limit patient participation (Drach-Zahavy & Shilman 2015). Instead of limiting participation, communication should foster cooperation with patients and help them understand the health information (Spruce 2015). HCWs should communicate clearly, supportively and respectfully (Flink et al. 2012a,b, Schwappach & Wernli 2011) and show interest in patients’ current state (Drach-Zahavy & Shilman 2015). Conditions are conducive for patient participation when information is provided based on patients’ individual needs and accompanied by explanations (Eldh 2006). HCWs should also identify patients’ ability and motivation to engage in safety behaviors (McInnes et al. 2014). Patients value this kind of information-sharing, it makes them feel engaged, informed and respected, and raises their eagerness to participate (Tobiano et al. 2015a).

However, some studies have found that information sharing is not necessarily easy and HCWs might be reluctant to share information (Hendersson 2003, Lawton & Armitage 2012, McTier et al. 2013, Rainey et al. 2013) and power with patients (Longtin et al. 2010, Tobiano et al. 2015a), which are key foundations for patient participation (Tobiano et al. 2015a). This is partly due to HCWs’ professional identities, which are often tied with knowing what is best for the patient, so sharing power with patients threatens their professional status (Lawton & Armitage 2012). Hence, HCWs can influence patients’ willingness and possibilities to participate through their beliefs, attitudes, and behaviors (Birks et al. 2011, Longtin et al. 2010).

Another barrier that can hinder patient participation is nurses’ task-oriented behavior (Drach-Zahavy & Shilman 2015, McTier et al. 2013, Tobiano et al. 2015a, Tobiano et al. 2018). McTier et al. (2013) studied patient participation in medication management during

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hospital admission and noted that nurses focused on medication administration and did not provide medication information to patients or encourage them to ask questions. Nurses did not appear to recognize patients’ opportunities to participate in the medication process, although it is an integral element of their daily care goals (McTier et al. 2013). Similarly, in an exploration of patient participation in the handover process, Drach-Zahavy & Shilmans (2015) found that, for patients, handover was an opportunity to get information, for example on care plans and schedules. In contrast, nurses found handover bothersome, because their overriding priority was to exchange information with other nurses. Thus, they felt that patients’ requests for information were unimportant or that handovers were not appropriate times for such questions. Hence, nurses tended to ignore patients and talked to each other as if the patients did not exist (Drach-Zahavy & Shilman 2015). Patients can interpret this as a clear sign that their care providers have no interest in their contributions (Flink et al. 2012a,b). Similar conclusions may be drawn if, for example, an HCW routinely measures blood sugar levels of patients who usually measure the levels themselves at home (Rainey et al. 2013).

Time constraints have also been identified as major barriers to patient participation (McTier et al. 2013, Schwappach & Wernli 2011) by HCWs (Longtin et al. 2010, Martin et al. 2013, Tobiano et al. 2015a), patients and their relatives (Rainey et al 2013). If patients have an impression that the staff are overburdened, the likelihood of speaking up about their concerns might be reduced unless they are certain that this is a sign of significant deterioration (Rainey et al. 2013). Conversely, reductions in units’ loadings foster patient initiatives to participate (Drach-Zahavy & Shilman 2015). High patient turnover may also diminish patient participation because if nurses do not know patients they may more readily undertake activities without consultation or considering patients’ willingness or expectations (Tobiano et al. 2015a).

Using patient-generated information is not always easy (Rainey et al. 2013, Sutton et al. 2015). HCWs seem to pay more attention to objective medical indicators of acute illness than patients’ subjective experiences (Rainey et al. 2013, Sutton et al. 2015), so HCWs may ignore this kind of patient information and be unwilling to act upon such information (Sutton et al. 2015). Martin et al. (2013) suggest that this might be due to a lack of systematic patient participation in patient safety, which is reflected in very diverse responses when patients mention errors. Reactions they recorded ranged from commending the patient´s attentiveness, correcting the error without openly acknowledging either the error or the patient’s intervention, to overt disagreement. These situations did not provoke any discussion with patients about patient safety either (Martin et al. 2013).

2.4.3 Organizational and society-related factors Organizational factors can hinder or even completely prevent patient participation in promoting safety, especially a paternalistic and hierarchical approach, which is still prevalent in care provision (Kemper et al. 2013) and limits patients’ opportunities to be active partners (Carman et al. 2013). Similarly, many patients have a traditional view of doctor-patient relationships and perceive doctors as beyond questioning, so they feel uncomfortable giving feedback to doctors (Carman et al. 2013, Eurobarometer 2012). This may be also due to patients’ general trust in the healthcare system and HCWs (De Brún et al. 2017, Eurobarometer 2012, Eurobarometer 2014, Sutton et al. 2015), which is a key factor in the ability to report and deal with patient safety concerns (Sutton et al. 2015).

Active patient participation can also be strongly influenced by cultural and social attitudes toward authority (Bartlôvâ et al. 2014). Policy-makers can create opportunities for patients to influence public policy. Similarly, foundations, nonprofit organizations, and government agencies can create funding mechanisms that support, or even require, patient participation in societal decisions and priority setting (Carman et al. 2013).

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Some of the biggest challenges, which are also connected to patient safety culture, are that HCOs often have many competing priorities, and lack both a quality improvement infrastructure and supporting values (Sutton et al. 2015). Thus, patient safety is not a common topic in communication between patients and professionals in everyday clinical practice (Martin et al. 2013). Previous studies also suggest that nurse managers have more positive views on patient safety than nurses (Turunen et al. 2013). When patient safety issues are not routinely considered, patients are unclear about their roles and what is expected of them, which may foster resistance to their participation amongst HCWs and managers (Coulter & Ellins 2006, Longtin et al. 2010, Ocloo & Matthews 2016).

Literature suggests that organizational and cultural change are crucial to promote patient participation (Sutton et al. 2015) and leaders have key roles to play in developing an appropriate structure to support patient participation at every level within their organizations (Kemper et al. 2013). This enables more collaborative working practices, thereby fostering acceptance of patients’ expertise by both patients and providers (Ocloo & Matthews 2016), and patients’ participation in their care (Carman et al. 2013, Longtin et al. 2010, Schwappach & Wernli 2010b).

2.5 STRATEGIES AND METHODS FOR PROMOTING PATIENT PARTICIPATION IN PATIENT SAFETY

Literature reveals that patients can promote their own or other´s safety in many ways while using healthcare services (Coulter & Ellins 2006, de Silva 2013, Peat et al. 2010, Sutton et al. 2014). As shown in Table 3, strategies to involve patients in safety improvement can be divided into three categories: 1) providing feedback, 2) planning improvement, and 3) safeguarding individual wellbeing (de Silva 2013). Table 3. Strategies to involve patients in safety improvements Findings Authors (year) 1) Providing feedback To measure patients’ experiences of

safety and outcomes Giles et al. 2013, Hernan et al. 2016, McEachan et al. 2014, O´Hara et al. 2017, Ricci-Cabello et al. 2015, Ricci-Cabello et al. 2016,

Patient incident reporting Daniels et al. 2012, Davis et al. 2013a, Doyle et al. 2013, Friedman et al. 2008, Gallagher & Mazor 2015, Guijaro et al. 2010, Harrison et al. 2015, King et al. 2010, Vincent & Davis 2012, Ward & Armitage 2012

Open disclosure of adverse events with patients

Birks et al. 2014, Gallagher et al. 2007, Gallagher et al. 2013, Guijarro et al. 2010, Iedema et al. 2011, Kachalia & Bates 2014, Lyu et al. 2014, Mazor et al. 2004

2) Planning improvement Participation in advisory councils, and

enhancing staff training Kemper et al. 2013

Involvement in safety research de Silva 2013, Jha et al. 2013 Table 3 to be continued

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Table 3 continues 3) Safeguarding individual wellbeing Through educational campaigns,

videos, leaflets etc. Davis et al. 2013b, de Silva 2013, Hart 2012, Imperial College London, OHA, Kutty & Weil 2006, NPSF 2016, Schwappach et al. 2013, The Joint Commission 2016

Marking surgical sites Bergal et al. 2010, Berger et al. 2014, Coulter & Ellins 2006, Russ et al. 2014, Schwappach 2010

Participation in improving hospital discharges (CTI)

Berger et al. 2014, Coleman et al. 2006, Voss et al. 2011

Ensuring hand hygiene Davis et al. 2013b, Hart 2012, McGuckin et al. 2004 Monitoring treatment and speaking up Rainey et al. 2015, Rathert et al. 2011 Bringing a list of medications Martin et al. 2013, Weingart et al. 2004 Sharing information, e.g. during

bedside handover Jangland et al. 2012, Tobiano et al. 2015a

Participation in pressure injury prevention

McInnes et al. 2014

2.5.1 Providing feedback Two of the most common ways to collect feedback from patients are surveys measuring patients’ experiences of safety and patients’ incident reporting. In recent years, several instruments have been developed to measure patients’ experiences of safety and outcomes in primary care (Hernan et al. 2016, Ricci-Cabello et al. 2015, Ricci-Cabello et al. 2016) and hospital settings (Giles et al. 2013, McEachan et al. 2014). Another way of acquiring feedback from patients about their experiences is patient incident reporting. Literature suggests that patients can provide reliable feedback about PSIs, thereby providing rich resources for learning and improvements (Harrison et al. 2015, King et al. 2010, Ward & Armitage 2012, Wright et al. 2016), and evaluating healthcare effectiveness and responsiveness (Doyle et al. 2013). Various studies also suggest that patients can identify poor and unsafe practices (Doyle et al. 2013, Harrison et al. 2015), many kinds of PSIs (Armitage et al. 2017, Walton et al. 2017, Ward & Armitage 2012), and adverse events (Andersson et al. 2015, Guijaro et al. 2010, King et al. 2010) spanning the full range of preventability and severity (Ward & Armitage 2012, Wright et al. 2016). Furthermore, patients can identify factors that they perceive as contributing to events they have encountered (Etchegaray et al. 2016).

Thus, experiences of patients, and their families, can provide an early warning system for care that is clearly risky (Gallagher & Mazor 2015, Vincent & Davis 2012) because they observe almost the whole care process, unlike individual clinical staff members, and hence have greater opportunities to witness harm, errors, and inconsistencies in care. Nevertheless, patients’ observations and reports are rarely documented in healthcare providers’ reporting systems (Daniels et al. 2012) or medical records (Davis et al. 2013a, Friedman et al. 2008).

A further important aspect is that patients who have experienced adverse events generally want to be involved in the management of such events, an apology, and to be informed about both how the incidents occurred and what is being done to prevent their recurrence (Birks et al. 2014, Gallagher et al. 2007, Guijarro et al. 2010, Iedema et al. 2011, Mazor et al. 2004). There is also consensus that it is an ethical duty to communicate openly with patients who have suffered from adverse events (Gallaghert et al. 2013). Nevertheless, open disclosure is not yet routine practice (Kachalia & Bates 2014, Lyu et al. 2014) because of professionals’ fear of lawsuits, a culture of blame in health services, clinicians’ lack of confidence in their own communication skills, and general doubts about the efficacy and effectiveness of incident disclosure (Studdert et al. 2010, White et al. 2008). Similarly,

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patients are not always satisfied with the way PSIs are handled. They want better preparation, more discussions about what went wrong, more support and more information about subsequent improvements of processes (Iedema et al. 2011).

Other, considerably less frequently used methods for acquiring information about patients’ experiences include various kinds of interviews (DeBrún et al. 2017, Iedema et al. 2011, O´Hara et al. 2017), critical incident techniques (Eriksson et al. 2016), focus groups and panels (Rathert et al. 2011), written or videoed patient stories (Cox & Logio 2011) and complaint analysis (Reader et al. 2014).

2.5.2 Planning improvement Patients can assess current services and processes from a patient perspective, and thus provide information based on their experience and identify improvement opportunities that HCWs and organizational leaders may not see. They can also participate in advisory councils and enhance staff training (Kemper et al. 2013). In NHS organizations there is even a statutory obligation to involve patients and the public when planning health services and developing service provision strategies (Health and Social Care Act 2001).

There is also emerging interest in ways to involve patients in educating professionals about safety, but research in this area is still sparse (de Silva 2013). Jha et al. (2013) obtained encouraging results from tests of the feasibility and acceptability of patient-led educational interventions for newly qualified doctors with both patients and doctors. Patients who had confronted harms shared their stories with doctors and discussed patient safety issues, exploring the causes and consequences of safety incidents and lessons to be learned from them. Both parties accepted this intervention and it enhanced doctors’ attitudes towards patient participation (Jha et al. 2013).

2.5.3 Safeguarding individual wellbeing Efforts to raise awareness of patient safety and encourage patients to participate in its promotion have been made through educational campaigns and dissemination of various kinds of leaflets, videos and posters (de Silva 2013). Perhaps the best known and most extensive campaign is the Joint Commissions´ Speak Up™ patient safety program. This has been extended to more than 40 countries worldwide and focuses on encouraging patients to speak up if they have questions or concerns, pay attention to the care they receive, educate themselves about their health, know what medicines they are taking and why, use a HCO that they have carefully checked and participate in all decisions about their treatment (The Joint Commission 2016). Similar campaigns include, for example, the "It's Safe to Ask" campaign, which encourages patients and families to request the information they need in order to become active participants in their care (http://www.mips.ca) and “Your Health Care — Be Involved” campaign, designed to empower patients, enhance patient safety and promote better health outcomes by providing five easy-to-understand tips for patients to use in any healthcare setting (OHA, Kutty & Weil 2006). In recent years various kinds of patient safety awareness weeks have also been launched worldwide with diverse themes for HCOs to support e.g. patient participation (NPSF 2016).

In addition to the abovementioned large-scale campaigns, attempts have been made to promote patients’ knowledge, awareness and encouragement using videos, leaflets and posters (Hart 2012, de Silva 2013, Davis et al. 2013b, Schwappach et al. 2013). For example, the Participate Inform Notice Know (PINK) video is intended to help prevent errors in care by promoting patient participation behaviors, such as reporting PSIs, providing HCWs with information about their current medication regimen and allergies, and telling doctors or nurses if they have not received their medication (Imperial College London). An example of a leaflet is the Please Ask about staying in hospital leaflet, intended to make patients feel more informed about their healthcare and what things patients should notice when they are in care (NHS 2010). The most recent intervention in this area is ThinkSAFE,

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which offers a range of tips and tools to support information sharing between patients, their families and HCWs during hospital stays (www.thinksafe.care).

Multiple individual interventions to promote patient participation have also been tested. For example, attempts have been made to involve patients in preventing wrong-side surgery by marking surgical sites themselves (Bergal et al. 2010), since the evidence supports the use of surgical checklists to reduce postoperative complications and mortality (Bergs et al. 2014, Treadwell et al. 2014, Weiser et al. 2010). Patients have positive attitudes towards checklists and agree that they could improve their safety and surgical team performance (Russ et al. 2014). On the other hand, there is also evidence that patients do not always comply with requests to mark the correct surgical site (Berger et al. 2014, Coulter & Ellins 2006, Schwappach 2010).

In addition, there have been efforts to encourage patients to participate in improving hospital discharges. For example, the Care Transitions Intervention (CTI) focuses on securing high-risk patients’ discharges by empowering them to self-manage and communicate more effectively with their providers, enabling patients to understand the signs and symptoms of deterioration in their condition before emergency issues occur, emphasizing the importance of follow-up doctor visits, and helping them locate other sources of continued support. The intervention includes a home visit within three days, a telephone call within 7 to 10 days, and final telephone call within 30 days from discharge. The intervention has proved to be effective for reducing readmission rates (Coleman et al. 2006, Voss et al. 2011).

Attempts have also been made to involve patients in the improvement or maintenance of high standards of hand hygiene by asking HCWs with direct contact if they have washed their hands and encouraging patients to ask providers to wash their hands (Davis et al. 2013b, Hart 2012, McGuckin et al. 2004).

Patient participation in promoting medication safety may include diverse kinds of interventions, for example monitoring treatment and speaking up. For example, patients can query doses (Rainey et al. 2015, Rathert et al. 2011), bring lists of medications, familiarize themselves with their medical records, and search for additional knowledge about their treatments from other sources, even if these actions are not preceded by any systematic encouragement by health professionals (Martin et al. 2013). However, in a randomized controlled trial with hospitalized patients, supplying individual medication cards listing patients’ current medications (updated every 3 days) in addition to general drug safety information, did not raise patients’ awareness of medication mistakes or their experiences of drug-related problems (Weingart et al. 2004). Thus, the general drug safety information (provided to both patients who received the individual medication cards and controls who did not) had the strongest impact on patients.’

Patients can also play an important role, as they recognize themselves, in pressure injury prevention, through mobilizing, changing position, and following good skincare and hydration practices (McInnes et al. 2014). However, patient knowledge of pressure injury prevention was found to be highly variable, so HCWs should be able to identify patients’ abilities to prevent pressure injuries, support adherence to prevention regimens and management of pain and comfort levels to facilitate movement and repositioning (Ibid.).

Further, to improve understanding of patients’ goals by all members of healthcare teams, patients can write down what is important to them on Tell-us cards. Use of these cards has provided significant improvements in patients’ abilities to participate in decisions about their nursing and medical care, and is well accepted by patients, nurses, assistant nurses and doctors (Jangland et al. 2012).

Moreover, information-sharing activities, such as bedside handover, should be promoted on medical wards to enhance patient participation because it may enhance all elements of patient participation, assessment, planning, knowledge of the patient and nurses, and patient empowerment (Tobiano et al. 2015a).

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2.6 EFFECTIVENESS OF INTERVENTIONS TO PROMOTE PATIENT PARTICIPATION IN PATIENT SAFETY

Various authors have addressed the potential for involving patients in promoting their own and others’ safety (Ocloo & Matthews 2016, Peat et al. 2010, Sutton et al. 2015) and to reform healthcare and improve the quality of care (Spruce 2015). Patient participation is regarded as one of the most important components of high-quality care and associated with improved patient outcomes, such as improvements in self-management of chronic diseases (Coulter & Ellins 2006, Longtin et al. 2010, Peat et al. 2010) and reductions in both mortality (Meterko et al. 2010, Wong et al. 2015) and risks of adverse events (Weingart et al. 2011). However, little is known about possible negative effects of patients’ participation in promotion of their own or other´s care (Peat et al. 2010, Watt et al. 2009). A few studies, published around the turn of the millennium, have suggested that patient participation may impair patient-HCW relationships by increasing patients´ anxiety (Peat et al. 2010). Moreover, it could cause inappropriate shifting of responsibility onto patients, which may also disproportionately burden already disadvantaged patients (Cahill 1998, Entwistle 2004, Entwistle et al. 2005). Further, if patients are asked to participate, for example, in hospital design groups, they might feel frustrated because they define safety and quality more broadly than healthcare professionals and hence unable to contribute effectively by introducing a patient perspective into the development and improvement of services (Peat et al. 2010).

Nevertheless, there are also promising results regarding the effectiveness of patient participation interventions. For example, Tell Us cards allowing patients to write down specific questions and concerns during their care or before discharge from surgical care units have significantly increased patients’ ability to participate in decision-making about their nursing and medical care, relative to a control group who were not given the cards (Jangland et al. 2012). Similarly, using the PINK video to inform patients about participating in the management of their own healthcare, and encourage them to do so, or the Please Ask about Staying in Hospital leaflet to make patients feel more informed about their healthcare has had positive results. Inter alia, patients felt significantly more comfortable about asking doctors or nurses whether they had washed their hands or notifying doctors and nurses about problems with their care (Davis et al. 2013b). Further, patient participation in hospital infection campaigns has led to significant improvements in hand hygiene compliance (Coulter & Ellins 2006). Yet another example of a successful patient safety program is SAFE OR SORRY?, involving simultaneous implementation of multiple guidelines (including patient involvement through folders for the prevention of pressure ulcers, urinary tract infection and falls) in nursing homes and hospitals. Intervention groups experienced 43% and 33% fewer adverse events than usual care groups in hospitals and nursing homes, respectively, and the results demonstrated the possibility (for the first time) of implementing multiple guidelines simultaneously and effectively (van Gaal et al. 2009, 2011a, 2011b). Good results have also been achieved with the Care Transitions Intervention (CTI), including a 30% reduction in hospital readmission in a healthcare environment in the USA that was already performing substantially better than the national average (Coleman et al. 2006)

Despite the enthusiasm for interventions and promising results obtained from some, many recent studies have concluded that there is no clear evidence that they effectively promote patient participation in patient safety, and further study is needed (Berger et al. 2013, Hall et al. 2010, Peat et al. 2010, Sutton et al. 2015). There are also at least three major challenges.

First, measuring the impact of patient participation is complex and methodologically challenging (Staniszewska et al. 2011, Weingart et al. 2011,). Moreover, a literature review by Hall et al. (2010) revealed shortcomings in the methodological quality of many relevant

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studies. For example, experimental studies did not provide details regarding concealment of allocation, and only four out of 14 considered studies provided details of blinded outcome assessment (Hall et al. 2010). Further, some studies have lacked descriptions of the interventions, some have ignored or poorly described patients’ demographic and clinical characteristics, and assessing the long-term effectiveness of reported interventions is often difficult because of short follow-up times (Coulter & Ellins 2007). There are also shortcomings in content validity (Brett et al. 2014).

Second, there are few reliable and valid tools for measuring patient participation in healthcare (Phillips et al. 2016) that cover all the core elements of participation, such as shared decision-making, acknowledgement that patients have critical knowledge regarding their own health and care needs, and promotion of self-care. Moreover, tools for measuring patient participation in patient safety in primary care (Hernan et al. 2016, Ricci-Cabello et al. 2015, Ricci-Cabello et al. 2016) and hospital settings (Giles et al. 2013, McEachan et al. 2014) have only been developed in the last few years.

Third, patient participation and patient safety are complex, multidimensional concepts and there is no consensus regarding optimal ways to involve diverse patients rather than a few selected individuals (Ocloo & Matthews, 2016). Thus, patient participation is a complex intervention in itself, with numerous interacting elements that make it challenging to evaluate (Hallberg 2015, MRC 2006,). As literature shows, most studies in this area have provided narrative descriptions of data (Brett et al. 2014) and there is a need for a paradigm shift towards robust measurement of the impact of participation to complement qualitative explorations (Staniszewska et al. 2011).

Patients’ incident reporting is one of the most common ways for patients to participate in promoting patient safety. Although there have been discussions regarding the false-positive rate for patient reporting of medication errors than those detected through doctor and nurse reporting (Kaboli et al. 2010), many studies have shown that patients can identify poor and unsafe practices (Doyle et al. 2013, Harrison et al. 2015), and adverse events (Guijarro et al. 2010, King et al. 2010). Thus, they can provide reliable reports that are potentially rich resources for learning and improvements (Harrison et al. 2015, King et al. 2010, Ward & Armitage 2012), as well as for evaluating healthcare effectiveness and responsiveness (Doyle et al. 2013).

Similarly, patient incident reporting systems offer opportunities to identify risks and improve procedures, thereby acting as important instruments for organizational learning (Howell et al. 2016, Macrae 2016, Sujan 2015) and providing valuable insights into reasons why patients may be harmed (Macrae 2016, Pham et al. 2013). However, the systems applied have been found to have several limitations, for example they detect only minor rates of PSIs (Pham et al. 2013), generate too many reports and poorly measure safety performance (Macrae 2016, Pham et al. 2013). Most alarmingly, there are difficulties in using PSI reports to improve safety in healthcare (Andersson et al. 2013, Macrae 2016, Mitchell et al. 2016, Stavropoulou et al. 2015). The main barriers that have prevented realization of incident reporting’s full potential are poor analysis of reports, inadequate engagement of doctors, insufficient actions after incidents, inadequate funding and institutional support of incident-reporting systems and inadequate use of evolving health information technology (Mitchell et al. 2016). Further, there could be too many recommendations, which are contradictory, or too simple, leading clinicians to dismiss the recommendations as unlikely to be effective (Anderson et al. 2013). This challenge could also reflect healthcare organizations’ absorptive capacity, i.e., their ability to manage and process knowledge to improve performance (Harvey et al. 2015).

In order to resolve these challenges, hospitals should focus on generating solutions for their own safety problems that can then be shared nationally (Howell et al. 2017) and take incident reporting seriously (Mitchell et al. 2016). In addition, patients’ reports should not

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be regarded as too subjective, mood-orientated and divorced from ‘real’ clinical work (Doyle et al. 2013).

To tackle these challenges, literature suggests also solutions. Working together with patients through conceptualization, theorization and development of instruments would strengthen both the effectiveness and acceptability of interventions, according to several studies (Davis et al. 2015, Peat et al. 2010, Staniszewska et al. 2011) and thus promote complex implementation of interventions (Ocloo & Matthews 2016). Patients can also potentially work with researchers in every stage of research (Brett et al. 2014, Richards 2015) and help implement research findings (Richards 2015).

2.7 SUMMARY OF THE THEORETICAL STUDY BACKGROUND

Due to the complexity of healthcare, diverse perspectives including professionals’, administrators’ and patients’ views are required for efficient identification of effective interventions to promote patient safety. A framework for patient participation in promoting patient safety based on the literature is illustrated in Figure 2.

In recent decades, the role of the patient has developed from a passive recipient of care to a more active, empowered, and informed co-producer of health. There are also interests in the potential for involving patients in promoting their own and others’ safety as well as developing healthcare systems and improving the quality of care. Nonetheless, the concept of patient participation remains poorly defined and there are uncertainties regarding its meaning in different complex healthcare settings and situations. This is partly because the development of patient safety regimens is driven by system thinking and learning from safety incidents, which is strongly rooted in health professionals’ perspectives. In addition, patients do not have unified interpretations of safety and what it means to be safe, and their interpretations are also context-dependent. Moreover, there is no clear evidence that interventions to promote patient participation in patient safety are effective, and further study is needed, especially from patients’ perspectives.

Literature reveals that patients can promote their own or other’s safety while using healthcare services. They can provide feedback to HCWs or HCOs, plan improvements, e.g. in advisory councils, or enhance staff training, and safeguard their individual wellbeing and safety, e.g. by updating and bringing medication lists when admitted to hospital, using checklists, and asking questions about unclear aspects of their care. However, multiple factors (including diverse patient-, healthcare professional-, organization- and society-related factors) influence how and to what extent patients are willing and able to participate. It has also been recognized that there are several levels of participation, from consultation to partnership and shared leadership, but the goal is not always to progress towards partnership and shared leadership, because it is not necessarily ideal, or even possible, for every patient. Different levels of participation are needed in different healthcare situations.

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Figure 2. Summary of the study framework

3 Purpose and research questions of the study

The purpose of this study was to describe and explain the patients’ and patient safety experts’ views of the patient safety and patient participation in the promoting patient safety. To do so, new knowledge was produced about patients' participation in the promotion of patient safety using patient-reported patient safety incident reports, patient safety experts' views of patient participation and patients' views of patient safety.

Specific research questions are as follows:

1. What kinds of views do patients have regarding patient safety (treatment safety, device safety, medication safety, and participation in promoting patient safety), and how do those views influence their ratings of patient safety? (Article I, Article IV, summary)

2. What factors explain internal medicine patients’ participation in promoting patient

safety? (Article IV)

3. How are patient-reported patient safety incident reports used in organizations to promote patient safety? (Article III)

4. What kind of views patient safety experts have on patient participation in the

promotion of patient safety? (Article II)

Results of the studies may facilitate evaluation of the state of patient safety, needs to improve patient safety and possible ways to do so. Knowledge of factors that influence patient participation should help HCOs to design interventions in which patients are willing to participate. Furthermore, the results may help healthcare professionals' and patients’ safety-related education. Thus, they may support efforts to improve patients' participation in the promotion of patient safety, and hence the safety of care provided, in diverse settings.

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4 Methods

4.1 DESIGN

Patients' participation in promoting patient safety was studied from both patients’ perspectives (Studies I-III) and patient safety experts’ perspectives (Study IV). The samples, settings, data collection procedures, and data analysis methods used in each of the studies differed, as shown in Table 4. Table 4. Descriptions of sub-studies Sub-Studies/ Articles Design Sample and

setting Data collection

Data analysis

Patient perspective SUB-STUDY I Article I Safety as experienced by patients themselves: A Finnish survey of the most recent period of care

Descriptive, Cross sectional

Consecutive sample of patients who were treated in day surgery units or inpatient wards (n=175), in one healthcare and social service organization in Finland using the PEPS questionnaire

Survey study, March-April 2011

Descriptive statistics, Kolmogorov- Smirnov test, Mann-Whitney U-test, Kruskall-Wallis test, logistic regression analysis

SUB-STUDY II Article IV Patient participation in patient safety - an exploration of promoting factors

Correlational, Cross sectional

Total sample of internal medicine patients (n=462) in all five university hospitals in Finland using the PEPS questionnaire

Survey study, March – December 2015

Descriptive statistics, Kolmogorov-Smirnov test, Mann-Whitney U-test, Kruskall-Wallis U-test, Principal Component Analysis, multiple linear regression analysis

SUB-STUDY III Article III: Patient-reported experiences of patient safety incidents need to be utilized more systematically in promoting safe care

Descriptive, Register study

Total sample of patients’ patient safety incident reports from 15 organizations in Finland (n=656)

Register study, August 2009- September 2015

Descriptive statistics, inductive qualitative content analysis

Patient safety expert views SUB-STUDY IV Article II: Patient participation in patient safety still missing: Patient safety experts’ views

Descriptive, Cross sectional

Purposive sample of Finnish patient safety experts (n=21)

Electronic web-based survey and interviews, September –December 2014

Descriptive statistics, inductive qualitative content analysis

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4.2 SURVEYS OF PATIENTS’ VIEWS OF PATIENT SAFETY (SUB-STUDY I AND II)

4.2.1 Development and validity and reliability of the PEPS instrument Phase I (2010-2011) and used in Article I The Patients’ Experiences of Patient Safety (PEPS) questionnaire was formulated using information obtained from the Finnish Patient Safety Strategy (MSAH 2009) and a conceptual model of factors that influence patient participation in preventing errors presented by Longtin et al. (2010) and (systematic) literature review in 2010. It was designed by the research group involved in the Patient Safety Culture Project based at the University of Eastern Finland in 2010 and 2011.

The questionnaire was divided into two parts: one that asked about patients' experiences of safety during their last treatment period, while the other sought their general views on patient safety. Both parts covered four domains: treatment safety, device safety, medication safety, and patient participation in promoting safety. Altogether, there were five background questions, five closed-ended questions, two open-ended questions and 48 statements rated on a 5-point scale assessing the participant´s level of agreement (1= totally disagree, 2=somewhat disagree, 3=somewhat agree, 4=totally agree, and 5=did not relate to my period of care/don’t know).

The validity and reliability of the PEPS questionnaire were ascertained (Burns & Grove 2009). The questionnaire’s content validity was supported by its initial foundations in the literature review, Finnish Patient Safety Strategy (MSAH 2009) and conceptual model of factors that influence patient participation in preventing errors presented by Longtin et al. (2010). Further, four national PSEs (the chief nursing officer of a university hospital, a representative of a national patient organization, a service quality manager of a central hospital, and a healthcare development project manager [medical doctor]) and five patients evaluated the relevance of items and the whole questionnaire. Their evaluations prompted several amendments of the questionnaire.

Construct validity (for the patients´ general views –part) was examined with Principal Component Analysis (PCA) with varimax rotation after checking that the data met the Kaiser-Meyer-Olkin (KMO) criterion of sampling adequacy (KMO value >0.6) and Bartlett´s Test of Sphericity criterion (p<0.001) of sufficiently large correlations. Eight Principal Components (factors; P1-P8, Table 6) with eigenvalues >1 were retained, explaining 68.3% of the variance (Grove et al. 2013, 566-569, Tabachnick & Fidell 2014). In addition, four sumvariables of patients’ experiences of safety during their recent period of care were formulated in this phase of the study, based on the literature and responses to the PEPS questionnaire.

Cronbach's alpha values of 0.88 for the whole PEPS scale and 0.77-0.88 for each of the components and composite variables were obtained, indicating that the newly developed PEPS questionnaire had good internal consistency (Grove et al. 2013, 391-392, Polit & Beck 2010). Details are presented in Tables 5 and 6.

Table 5. Sumvariables of patients’ experience of safety during their recent period of care in Survey I Sumvariables Number

of items Cronbach’s

alpha Treatment safety 3 0.77 Device safety 2 0.88 Medication safety 8 0.86 Patient participation 8 0.88

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Table 6. Principal Components (Factors, P1-P8) explaining 68.3% of the variance in patients’ general views in patient safety Principal Components Factor

loadings Number of items

Cronbach’s alpha

P1 Communicating with healthcare staff 0.811-0.451 4 0.720 P2 Patient participation in own care 0.744-0.517 5 0.709 P3 Asking healthcare staff if they have washed their hands

0.918-0.908 2 0.939

P4 Patients trust in healthcare staff and safety of their care

0.781-0.442 4 0.685

P5 Identifying error(s) 0.867-0.789 2 0.849 P6 Informing patients about devices used in care 0.874-0.798 2 0.698 P7 Patients knowledge of safety 0.822-0.778 2 0.713 P8 Using identification bracelets 0.874-0.732 2 0.794

Phase II (2014-2015) and used in Article IV In phase II, only the PEPS questionnaire’s second part, which was designed to measure patients’ experiences of safety during their last treatment period, was used to collect data. However, to obtain more relevant information regarding the second set of patient participants (462 internal medicine patients; Table 4) three background questions, 15 items and five closed-ended questions were added. Thus, the applied instrument comprised eight background questions, 36 items and eight closed-ended questions in total. The questionnaire covered the same four domains as in phase I: patients’ experiences of treatment safety, device safety, medication safety, and patient participation in promoting patient safety.

Principal Component Analysis (PCA) with Varimax rotation was conducted to examine the factor structure of the patient’s experience of patient participation. The data met the Kaiser-Meyer-Olkin (KMO) criterion of sampling adequacy (KMO value >0.9) and three Principal Components (factors; Table 8) with eigenvalues >1 were retained, explaining 63.5% of the variance (Grove et al. 2013, 566-569, Tabachnick & Fidell 2014).

Cronbach's alpha values of 0.929 for the instrument and 0.780-0.899 for the sub-scales corresponding to the three factors were obtained, indicating high internal consistency (Grove et al. 2013, 391-392). Details are presented in Table 7 and 8.

Table 7. Sumvariables of patients’ experience of safety during their recent period of care in Survey II Sumvariables Number

of items Cronbach’s

alpha Treatment safety 4 0.809 Device safety 3 0.787 Medication safety 12 0.820

27

Table 8. Factors explaining 63.5% of patient’s experience of patient participation in promoting patient safety during their last treatment period, associated items, Cronbach’s alpha values and factor loadings Principal Components Factor

loadings Number of items

Cronbach’s alpha

P1 Informing patients about and encouraging participation, 23.4% variance explained

0.779-0.650 6 0.899

P2 Providing patients with necessary information in an understandable form in a timely manner, 22.3% variance explained

0.855-0.468 8 0.879

P3 Patients’ ability to identify patient safety incidents, 11.3% variance explained

0.904-0.378 3 0.780

4.2.2 Samples, data collections and data analysis Sub-Study I, article I Data were collected using the purpose-designed PEPS questionnaire. The target population was consecutive sample of patients who were treated in a day surgery unit or inpatient wards of one Finnish joint municipal healthcare and social service authority in 2011. Patients were eligible to participate if they were 18 years or older and able to complete the questionnaire themselves. Nurses informed patients and invited them to participate at the end of their period of care. Each participating patient completed the questionnaire at his or her home and returned it to the researchers by mail. The response rate was 48% (n=175).

The acquired data were analyzed using the Statistical Package for Social Sciences for Windows version 17.0 (SPSS, Inc., Chicago, IL). The Kolmogorov–Smirnov test showed that data did not meet the normal distribution criterion for parametric tests (p<0.05), so non- parametric (Mann-Whitney U and Kruskall-Wallis) tests were used. At the beginning of the analysis the categories “totally agree” and “somewhat agree” were combined into the category “agree”, and the “totally disagree” and “somewhat disagree” categories were combined into the category “disagree” to meet the Chi-square test criterion that no more than 20% of the cells should have expected counts less than 5. A logistic regression model was used to determine the degree to which the background variables explained patients’ assessments of the level of patient safety.

Sub-Study II, article IV Determining the optimal sample size a priori power analysis was made. A sample size of 220 patients was required to achieve a power of 95% given significance level of 0.005 and effect size of 0.5 in the Wilcoxon-Mann-Whitney test. (Grove et al. 2013, 367-368, Suresh & Chandrashekara 2012).

Data were collected from 462 patients who had been treated in 18 internal medicine wards (in total) in all five Finnish university hospitals in 2015 (consecutive sample). The response rate was 36,4%. The wards were not necessarily called in every hospital as internal medicine wards, due to the breadth of internal medicine, thus the patients had diverse diagnoses and were being treated (for example), in cardiological, gastroenterological, endocrinological, nephrological, rheumatological and hematological wards.

Inclusion criteria for patients were that they were 18 years or older, Finnish speaking, able to complete the questionnaire themselves and discharged from the hospital to their own home. On the day of discharge, nurses informed patients about the study and invited them to participate. Then patients received an envelope that included the questionnaire, a letter providing information about the study, and another postpaid envelope. Patients filled the questionnaire at their home and returned it to the University of Eastern Finland.

28

Data were analyzed using the Statistical Package for Social Sciences for Windows version 17.0 (SPSS Inc., Chicago, IL). The Kolmogorov–Smirnov test showed that the data did not meet the normal distribution criterion for parametric tests (p<0.05), so non-parametric (Mann-Whitney U and Kruskall-Wallis) tests were used when analyzing differences between background variables and responses regarding safety domains.

Patients´views of patient participation in patient safety were explored by Principal Component Analysis (PCA) with varimax rotation after checking that the data met the Kaiser-Meyer-Olkin (KMO) criterion of sampling adequacy (KMO value >0.6) and Bartlett´s Test of Sphericity criterion (p<0.001) of sufficiently large correlations (Tabachnick & Fidell 2014). To examine possible explaining factors of internal patients’ participation, a multiple regression model was used. Differences were considered significant if p ≤ 0.05 (Grove et al. 2013).

4.3 PATIENT-REPORTED PATIENT SAFETY INCIDENTS (SUB-STUDY III)

4.4.1 Sample, data collection Sub-study III was a retrospective register study. In 2009 a web-based voluntary error-reporting system (HaiPro) for patients was launched in Finland. By the end of September 2014, 12 out of 20 hospital districts and three joint municipal authorities or cities in Finland, covering 47% of the Finnish population at that time, had introduced the system. In all of these 15 HCOs patients can report PSIs electronically via forms on the organizations' websites, which include mandatory fields such as the date and time of the incident, descriptions of what happened, how it happened, and consequences for patients. Patients can suggest measures to prevent recurrence of the events, if they want to. These PSI reports can be submitted anonymously or with contact information, if patients want HCOs to contact them (Appendix 2).

The data included all PSI reports submitted via the HaiPro system from August 2009 to June 2015 that had been completely analyzed and processed by the HCOs according to their routine procedures (690 of 930 in total). After removing 11 duplicates, three test reports, and 20 reports that did not relate to patient safety, the final dataset consisted of 656 PSI reports.

4.4.2 Data analysis Patients’ written responses to open-ended questions were analyzed by inductive qualitative content analysis, focusing solely on the manifest content of the data. First, the researcher read the data several times to get an overview of the whole dataset. Then the data were divided into meaning units and further to condensed meaning units. Based on condensed meaning units 17 sub-themes and finally four themes were formulated (Graneheim & Lundmark 2004, Elo & Kyngäs 2008, Vaismoradi et al. 2016). Although the researcher had main responsibility for analyzing the data, multiple discussions were held among the research group to reach consensus and ensure the reliability and credibility of the formulated themes.

The data consisted of PSI reports that had been classified by the HCOs’ analysts in terms of incident types, nature of the event (near miss or happened to patient), risk level, and consequences for the patients. Only those classifications which HCOs' analyst had chosen as "other" (n=107) and "not known" (n=31) as an incident type were reclassified in this study. Based on that reclassification three new incident type were formed; “missing patient”, “related to building”, and “related to data protection or professional secrecy”. Quantitative data were analyzed using the Statistical Package for Social Sciences for Windows version 21.0 (IBM Corp., Armonk, NY). Cross-tabulation was used when analyzing connections between incident types, consequences for patients and risk levels.

29

4.5 SURVEY OF PATIENT SAFETY EXPERTS (SUB-STUDY IV)

4.5.1 Sample and data collection All study participants were members of the Patient Safety Expert (PSE) division of the Finnish Society for Patient Safety. PSEs are all healthcare professionals such as nurses, nurse managers, physicians or clinical specialists who promote and coordinate patient safety in their organizations in Finland. The society´s email list at the data collection time included 34 PSEs regarded as suitable participants for this study. An email was sent to all of these PSEs with a cover letter describing the study and its voluntary nature, together with a link to a questionnaire, which they were asked to complete (anonymously) if they were willing to participate. The questionnaire, developed for this study, included three closed-ended, six open-ended, and seven background questions. The open-ended questions concerned the PSEs’ views on: the patient’s role in promoting patient safety; things that enable or prevent patients’ participation in promotion of patient safety; the most important things to develop for promoting patient participation in patient safety; the kinds of tools they use to promote patient participation in treatment, medication, and device safety; and how they have involved patients in PSI management in their organizations. In addition, the PSEs were asked to assess the patient safety level (on a 5-point scale from 1= excellent to 5= not acceptable), and (on a 5-point scale from 1=very good to 5= very poor) how well the patients were involved in incident management, and how well the healthcare staff encouraged patients to promote patient safety in their own organizations.

Of the 34 PSEs approached, 19 completed the web-based questionnaire. The 15 who did not answer were offered the possibility to be interviewed by phone, and two participants accepted this option. Thus, the overall response rate was 62% (N=21). Data were collected between September and December 2014.

4.5.2 Data analysis The participants’ responses were analyzed using inductive qualitative content analysis, focusing solely on the manifest content of the qualitative data (Elo & Kyngäs 2008, Graneheim & Lundmark 2004, Vaismoradi et al. 2016). First the researcher transcribed the interviews verbatim and combined them with the data gathered from the web-based questionnaire. Participants’ responses to the open-ended questions varied greatly in length. Some gave single word or character responses, but most of them justified their views more extensively, generating 44 pages of text in total written in Times New Roman font size 12 with 1.5 line spacing. Second, all responses were read several times to form general impressions of the whole dataset. Meaningful units were then separated and condensed before being abstracted in condensed meaning units, from which sub-categories, categories, sub-themes and themes were successively formulated. The analytical process involved back and forth movements between the whole texts, condensed meaning units, categories and sub-themes, i.e. iterative checks for consistency between texts and all levels of interpretation.

Three overarching themes and eight sub-themes were identified during the inductive qualitative content analysis. The data were analyzed by the researcher and multiple discussions were held among the research group to reach consensus and ensure reliability and credibility of the formulated themes.

30

4.6 ETHICAL ISSUES

Ethical aspects of the study were considered by the University of Eastern Finland Committee on Research Ethics and favorable statements were obtained on 4.3.2011 (6/2011) and 5.6.2014 (13/2014). All studies were conducted in accordance with the Code of Ethics of the World Medical Association (WMA 2013) and Responsible conduct of research guidelines (Finnish Advisory Board on Research Integrity 2012) throughout the research, from the selection of topics to publication of results. Specific approval was obtained for the collection of each dataset. Permission to use HaiPro register data was granted to every hospital, city, social and healthcare district, or joint municipal authority that had introduced the web-based voluntary error-reporting system for patients and whos data was in the HaiPro database (managed by Awanic Oy, the company responsible for the system’s maintenance and further development). Permission to collect the quantitative data used in sub-studies I and II was obtained from each participating social and healthcare unit and university hospital. To collect data from Finnish PSEs, the Patient Safety Expert division of the Finnish Society for Patient Safety email list was used, so permission to use the list was obtained from the Patient Safety Expert division of the Finnish Society for Patient Safety.

To protect participants’ anonymity, the researcher had no connections with participating patients in any way during the collection of their views through either incident reports or questionnaires. Similarly, in the PSEs’ electronic survey the researcher had no connections with participants except in the phone interviews. To protect interviewees’ identities, their names and contact information were deleted immediately after the interviews and replaced with codes. Some of the patients’ incident reports included names of the doctors, nurses or where they were treated. Those names and other identifiers were deleted in the first phase of the data analysis to secure participants’ and/or healthcare professionals’ anonymity (Polit & Beck 2010).

Voluntariness of participation was ensured using cover letters that provided information about the study in terms of its purpose, voluntary and anonymous participation, maintenance of confidentiality, and right of participants to withdraw at any stage from the study. The cover letters also provided participants with research group members’ contact information for possible questions or need for possible clarifications (Grove et al. 2013). In this study, receipt of a filled questionnaire was regarded as evidence of informed consent of participants (Finnish Advisory Board on Research Integrity 2012). In the interviews, participants were given the same information as the cover letter provided for those who chose to complete the electronic web-based survey.

During all phases of the studies, the study procedures were performed in accordance with relevant laws and institutional guidelines. Similarly, relevant security procedures for storing the study data were followed. Electronic data were password-protected and only the researcher had access to it. The data were also stored from time to time on an external hard drive that was kept in a locked room that outsiders could not access. Paper survey data were also stored in the locked room.

Three years after acceptance of this thesis, paper data (questionnaires) will be shredded and electronic data will be erased using commercial software applications designed to remove all data from the storage device.

31

5 Results

5.1 PATIENTS’ VIEWS REGARDING PATIENT SAFETY AND PARTICIPATION

Data were acquired in a survey in spring 2011 of views of two groups of day surgery patients and inpatient ward patients in one organization (Article I) and another survey in autumn 2015 of internal medicine patients in all Finnish university hospitals (Article IV).

In survey 2011 patients´general views of patient safety were asked. Patients felt that social- and healthcare is safe in Finland (96,5%) and they trusted that they given right medications when hospitalized (97%) and that HCWs can use medical devices safely (98,9%). Patients were unanimous that they have right to know what medication they were given when hospitalized (99,4%) and wanted to know how their care has been planned (99,4%). They felt also easy to discuss with HCW´s about their care (94,6%) or their medication (97,7%), but asking if doctors or nurses had washed their hands was seen difficult (doctors 72,5%, nurses 68,4%). Patients were willing to learn how to promote safety of their own care (97,5%) and to participate in decision making (minor decision 94,5%, major decision 95,6%). Almost half of patients (49%) disagreed that they have good patient safety knowledge. Also identifying error(s) (43,5%) and near misses (52,4%) was seen diffigult. (Table 9).

Overall, most of the patients participating in both surveys (89.8 and 78.1%, respectively) rated patient safety levels as very good or excellent during their most recent period of care. (Article I and IV). However, a fifth of the participating patients in the second survey rated it as acceptable or worse (Table 10). Hospital and experienced error(s) were the only statistically significant background variables associated with patients’ ratings of the safety level. Patients who had not experienced error(s) rated it “excellent” or “very good” more frequently than patients who had experienced error(s) or patients who did not know if they had (93% vs. 64% and 65%, respectively; p<0.001). Additionally, patients who had been in hospital 4 assessed the patient safety level as “excellent” or “very good” more frequently than those who had been in hospitals 1, 2, 3 and 5 (93% vs. 62%, 79%, 79% and 77%, p<0.001). (Article IV)

Ta

ble

9. P

atie

nts’

gen

eral

vie

ws

of p

atie

nt s

afet

y an

d pa

rtic

ipat

ion

(α,

M,

SD

, %

, n)

S

tate

men

t C

ron

bac

h’s

al

ph

a

Mea

n

(SD

) To

tall

y d

isag

ree

(%)

Dis

agre

e

(%

)

Som

ewh

at

agre

e

(%)

Tota

lly

agre

e (%

)

n

Com

mu

nic

atin

g w

ith

hea

lth

care

sta

ff

0.7

20

3.

77 (

0.35

2)

W

hen

I am

in a

car

e in

stitu

tion

, I

have

the

rig

ht t

o kn

ow w

hat

med

icat

ions

are

giv

en

to m

e 3.

92 (

0.33

4)

0.6

0 6.

5 92

.9

170

It

fee

ls n

atur

al t

o m

e to

ask

doc

tors

or

nurs

es a

bout

my

med

icat

ion

3.86

(0.

440)

0.

6 1.

8 8.

9 88

.8

169

I

wan

t to

kno

w h

ow m

y tr

eatm

ent

has

been

pla

nned

3.

77 (

0.43

6)

0 0.

6 21

.9

77.5

16

9

It w

ould

fee

l eas

y fo

r m

e to

dis

cuss

my

trea

tmen

t an

d re

late

d is

sues

with

the

nurs

ing

staf

f 3.

56 (

0.65

4)

1.8

3.6

31.5

63

.1

168

Usi

ng

id

enti

fica

tion

bra

cele

ts

0.7

94

3.

76 (

0.51

4)

I

thin

k it is

impo

rtan

t to

che

ck t

he p

atie

nt’s

iden

tity

by a

skin

g ev

en if

the

pat

ient

is

wea

ring

an

iden

tific

atio

n br

acel

et

3.78

(0.

540)

1.

2 2.

5 12

.3

84.0

16

2

I

thin

k it is

a g

ood

thin

g th

at I

am

mad

e to

wea

r an

iden

tific

atio

n br

acel

et in

the

car

e in

stitut

ion

3.70

(0.

623)

1.

4 4.

3 17

.4

76.8

13

8

Info

rmin

g p

atie

nts

ab

ou

t d

evic

es u

sed

in c

are

0.6

98

3.

75 (

0.46

1)

I

thin

k th

e st

aff

resp

onsi

ble

for

my

care

has

the

dut

y to

tel

l pat

ient

s ab

out

the

equi

pmen

t us

ed in

the

ir c

are

3.74

(0.

528)

4.

3 0

17.2

78

.5

163

I

wou

ld li

ke t

o kn

ow in

adv

ance

if s

ome

equi

pmen

t us

ed in

my

care

is u

sed

on m

e 3.

77 (

0.50

2)

0 3.

6 16

.2

80.2

16

7 P

atie

nt

par

tici

pat

ion

in

ow

n c

are

0.7

09

3.

57 (

0.42

6)

I w

ould

like

to

lear

n ho

w I

can

impr

ove

the

safe

ty o

f m

y tr

eatm

ent

with

my

own

action

s 3.

68 (

0.51

9)

0 2.

4 27

.4

70.1

16

4

I

thin

k pa

tien

ts s

houl

d ac

tivel

y pa

rtic

ipat

e in

the

ir o

wn

care

3.

67 (

0.53

0)

0.6

1.2

28.3

69

.6

166

I

wou

ld b

e in

tere

sted

in p

artici

pating

in s

mal

l dec

isio

ns c

once

rnin

g m

y ca

re,

such

as

deci

ding

on

the

tim

e of

my

disc

harg

e 3.

61 (

0.63

2)

1.2

4.3

26.8

67

.7

164

I

wou

ld b

e in

tere

sted

in p

artici

pating

in m

ajor

dec

isio

ns c

once

rnin

g m

y ca

re,

such

as

sele

ctin

g th

e lin

e(s)

of tr

eatm

ent

3.54

(0.

645)

2.

1 2.

1 35

.6

60.3

14

6

I

thin

k pa

tien

ts s

houl

d be

abl

e to

act

ivel

y pa

rtic

ipat

e in

the

ir o

wn

care

at

any

stag

e of

the

illn

ess

3.36

(0.

761)

2.

5 9.

9 37

.0

50.6

16

2

T

able

9 t

o be

con

tinu

ed

33

Tabl

e 9

cont

inue

s

Sta

tem

ent

Cro

nb

ach

’s

alp

ha

M

ean

(S

D)

Tota

lly

dis

agre

e (%

)

Dis

agre

e

(%

)

Som

ewh

at

agre

e

(%)

Tota

lly

agre

e (%

)

n

Pat

ien

ts t

rust

in

hea

lth

care

sta

ff a

nd

saf

ety

of t

hei

r ca

re

0

.68

5

3.51

(0.

436)

I tr

ust

that

I a

m g

iven

the

cor

rect

med

icin

es w

hen

I am

in a

car

e in

stitut

ion

3.80

(0.

517)

1.

2 1.

8 12

.9

84.1

17

0

I tr

ust

that

the

sta

ff r

espo

nsib

le for

my

care

kno

w h

ow t

o m

anag

e th

e eq

uipm

ent

used

in

my

care

cor

rect

ly a

nd s

afel

y 3.

73 (

0.47

0)

0 1.

2 24

.6

74.3

17

1

I

thin

k he

alth

care

and

nur

sing

is s

afe

in F

inla

nd

3.53

(0.

588)

0.

6 3

39.1

57

.4

169

I

cons

ider

it li

kely

tha

t a

patien

t ca

nnot

be

inju

red

duri

ng h

ospi

tal t

reat

men

t in

Fin

land

2.

95 (

0.82

7)

5.5

20.1

48

.2

26.2

16

4 Id

enti

fyin

g e

rror

(s)

0.8

49

2.

56 (

0.79

9)

I

can

iden

tify

whe

n an

err

or h

as o

ccur

red

in m

y ca

re

2.63

(0.

833)

8.

3 35

.2

42.1

14

.5

145

I

can

iden

tify

whe

n an

err

or h

as n

earl

y oc

curr

ed in

my

care

2.

46 (

0.86

6)

13.1

39

.3

35.9

11

.7

145

Pat

ien

ts k

now

led

ge

of s

afet

y 0

.71

3

2.26

(0.

859)

I th

ink

I ha

ve a

lot

of in

form

atio

n ab

out

patie

nt s

afet

y 2.

51 (

0.88

2)

13.1

35

.9

37.9

13

.1

153

I

have

fam

iliar

ised

mys

elf w

ith

patien

t sa

fety

gui

des

(pat

ient

han

dboo

k an

d pa

tient

’s

chec

k lis

t)

2.0

(1.0

00)

40.5

28

.1

22.2

9.

2 15

3

Ask

ing

hea

lth

care

sta

ff i

f th

ey h

ave

was

hed

th

eir

han

ds

0.9

39

2.

07 (

0.97

1)

I w

ould

fin

d it e

asy

to a

sk a

nur

se w

heth

er h

e/sh

e ha

d w

ashe

d hi

s/he

r ha

nds

2.11

(1.

034)

34

.2

34.2

17

.7

13.9

15

8

I w

ould

fin

d it e

asy

to a

sk a

doc

tor

whe

ther

he/

she

had

was

hed

his/

her

hand

s 2.

0 (0

.946

) 35

.9

36.6

19

.0

8.5

153

Item

s le

ft o

uts

ide

of P

CA

(r<

0.3

0)

I

thin

k pa

tien

ts c

an h

elp

prev

ent

trea

tmen

t er

rors

3.

29 (

0.75

5)

3.2

8.3

44.2

44

.2

156

Th

e st

aff

resp

onsi

ble

for

the

patien

t’s c

are

shou

ld b

elie

ve a

pat

ient

say

ing

that

the

ir

med

icat

ions

are

inco

rrec

t 3.

15 (

0.82

8)

5.3

11.8

45

.4

37.5

15

2

Pa

tien

ts a

re p

artly

pers

onal

ly r

espo

nsib

le for

the

saf

ety

of t

heir

car

e 3.

08 (

0.82

4)

5.0

15.0

46

.9

33.1

16

0

Whe

n I

am in

a c

are

inst

itution

, I

take

all

med

icat

ions

giv

en t

o m

e w

itho

ut a

skin

g w

hat

they

are

2.

58 (

1.00

7)

17.6

27

.1

34.7

20

.6

170

* U

npub

lishe

d m

ater

ials

Table 10. Patients’ ratings of the patient safety level during their most recent period of care Patient safety level Survey 1 (n=175) Survey 2 (n=462) Mean (SD) 4.22 (0.63) 4.07 (0.74) % n % n 1=Not acceptable 0 0 0.2 1 2=Poor 0.6 1 0.4 2 3=Acceptable (average) 9.6 16 21.3 95 4=Very good 56.9 95 48.3 216 5=Excellent 32.9 55 29.8 133

Patients’ reported views of patient safety and participation (Table 11) showed that they were most satisfied with treatment safety (M=3.51). Patients trusted their HCWs and thought they were doing their best to ensure their safety (M=3.77) and felt safe during their care (M=3.76). Nevertheless, a fifth of patients (20%) reported that they were not told about the risks in their care and 16.4% disagreed that they were told about different treatment options. Patient trust in HCWs was also reflected in nearly unanimous agreement (by 97.6% of participants) that HCWs used medical devices properly and safely. However, nearly a fifth of patients indicated that they were not told about the devices used in their care and how they worked (16.4%), nor about how they should act if a device signaled an alarm (17.1%) (Article IV).

The overall rating of medication safety was quite high (M=3.39) and patients felt that they were fully aware about their medications when discharged (M=3.74) and their pain was treated well (M=3.71). However, substantial proportions indicated that they were not told about side effects of their medications or given written information about their new medicines (38.2 and 29.9%, respectively), and 36.9% indicated that they took all medicines that were given to them without asking what they were. (Article IV).

Patients were quite satisfied with the information provided (M=3.49) although almost a fifth (17.4%) thought that HCWs did not have enough time to discuss their care with them.

Patients were least satisfied with their ability to identify PSIs (M=3.02) and being informed about and encouraged to participate (M=2.87). Almost half (47.9%) were not told about patient safety and 51.7% were not told how to act if they noticed an error or near miss in their care. They also reported a need for improvements regarding participation in decision-making, because 31% disagreed that there was possibility to participate in decision-making regarding their own care, and similar proportions felt that doctors (27.9%) or nurses (28.9%) did not encourage them to do so. (Article IV).

35

Tabl

e 11

. Pa

tien

ts’ e

xper

ienc

es o

f pa

tien

t sa

fety

and

par

tici

patio

n (α

, M

, SD

, %

, n)

in t

heir

mos

t re

cent

per

iod

of c

are

Sta

tem

ent

Cro

nb

ach

’s

alp

ha

M

ean

(S

D)

Tota

lly

dis

agre

e (%

)

Dis

agre

e

(%

)

Som

ewh

at

agre

e (%

) To

tall

y ag

ree

(%)

n

Trea

tmen

t sa

fety

α=

0.80

9 3.

54 (

0.57

9)

H

CW

s di

d th

eir

best

to

ensu

re t

he s

afet

y of

my

care

. 3.

77 (

0.54

8)

1.8

0.7

16.6

80

.9

459

I

felt s

afe

duri

ng t

he c

are.

3.

76 (

0.57

8)

1.9

1.9

15.1

81

.2

459

I

was

tol

d ab

out

the

differ

ent

trea

tmen

t op

tions

whe

n I

was

in c

are.

3.

29 (

0.88

0)

5.9

10.5

31

.9

51.7

45

9

I w

as t

old

abou

t th

e ri

sks

rela

ted

to m

y ca

re.

3.21

(0.

931)

7.

3 13

30

.9

48.8

45

9 D

evic

e sa

fety

α=

0.7

87

3.51

(0.

691)

I th

ink

that

HC

Ws

used

med

ical

dev

ices

pro

perly

and

safe

ly.

3.78

(0.

512)

1

1.5

16.4

81

.2

459

H

CW

s to

ld m

e ho

w I

sho

uld

act

if a

med

ical

dev

ice

used

for

my

trea

tmen

t si

gnal

ed a

n al

arm

. 3.

37 (

0.96

5)

8.8

8.3

19.8

63

.1

459

H

CW

s to

ld m

e ab

out

the

med

ical

dev

ices

use

d fo

r m

y ca

re a

nd h

ow t

hey

oper

ated

.

3.31

(0.

894)

6.

4 10

30

53

.6

459

Med

icat

ion

saf

ety

α=0.

820

3.38

(0.

596)

I

was

ful

ly a

war

e ab

out

my

med

icat

ion

whe

n I

was

dis

char

ged.

3.

74 (

0.58

2)

1.6

2.3

16.6

79

.5

459

M

y pa

in w

as t

reat

ed w

ell w

hen

I w

as in

car

e.

3.71

(0.

624)

2.

1 2.

6 17

.8

77.4

45

9

I tr

uste

d th

at I

was

giv

en t

he r

ight

med

icat

ions

. 3.

57 (

0.76

8)

4.4

3.9

22.2

69

.4

459

I

thin

k it w

as e

asy

to a

sk m

edic

atio

ns fro

m n

urse

s an

d do

ctor

s.

3.55

(0.

811)

4.

9 5.

8 18

.2

71

459

I

was

info

rmed

abo

ut w

hy I

was

pre

scri

bed

a ne

w m

edic

ine.

3.

52 (

0.86

3)

6.4

5.5

18

70.1

45

9

I w

as v

erba

lly in

form

ed o

f m

y ne

w m

edic

atio

n.

3.51

(0.

852)

6.

1 5.

3 20

.4

68.2

45

9

I re

ceiv

ed a

n up

-to-

date

med

icat

ion

list

whe

n I

was

dis

char

ged.

3.

50 (

1.00

1)

11.1

4.

1 8.

6 76

.2

459

I

was

tol

d ho

w t

o us

e m

y m

edic

atio

n (e

.g.

regu

larl

y or

whe

n ne

eded

, be

fore

or

afte

r di

nner

).

3.48

(0.

885)

7.

1 5.

2 20

.2

67.5

45

9

I

aske

d ab

out

my

med

icat

ions

whe

n I

was

in c

are.

3.

31 (

0.96

1)

8.9

8.6

24.9

57

.5

459

I

was

giv

en w

ritt

en in

form

atio

n ab

out

my

new

med

icin

es.

3.00

(1.

145)

17

.7

12.2

22

.4

47.8

45

9

I to

ok a

ll m

edic

ines

tha

t w

ere

give

n to

me

witho

ut a

skin

g w

hat

they

wer

e.

2.89

(1.

166)

18

.6

18.3

18

.8

44.3

45

9

I w

as t

old

abou

t w

hat

kind

of si

de e

ffec

ts t

he d

rugs

I u

se h

ave.

2.

80 (

1.11

7)

18.1

20

.2

25.7

36

45

9 P

atie

nt

par

tici

pat

ion

F1

Pro

vid

ing

pat

ien

ts w

ith

nec

essa

ry i

nfo

rmat

ion

in

an

u

nd

erst

and

able

for

m a

nd

tim

ely

man

ner

α=

0.8

79

3.49

(0.

584)

I

follo

wed

inst

ruct

ions

tha

t w

ere

give

n to

me.

3.

80 (

0.52

2)

1.6

0.7

14.1

83

.6

434

N

urse

s sp

oke

to m

e in

a w

ay t

hat

I co

uld

unde

rsta

nd.

3.70

(0.

633)

2.

1 3.

2 17

.8

76.9

43

7

Tab

le 1

1 to

be

cont

inue

d

36

Tabl

e 11

con

tinu

es

Cro

nb

ach

’s

alp

ha

Mea

n

(SD

) To

tall

y d

isag

ree

(%)

Dis

agre

e

(%

)

Som

ewh

at

agre

e (%

) To

tall

y ag

ree

(%)

n

D

octo

rs s

poke

to

me

in a

way

tha

t I

coul

d un

ders

tand

. 3.

61 (

0.71

1)

3.0

4.4

21.8

70

.9

436

H

CW

s al

way

s ga

ve m

e th

e in

form

atio

n th

at I

nee

ded.

3.

57 (

0.71

2)

2.5

5.5

24.9

67

.1

438

H

CW

s en

cour

aged

me

to a

sk a

bout

thi

ngs

that

wer

e no

t cl

ear

to m

e.

3.36

(0.

839)

4.

1 11

.2

29.1

55

.6

412

Pa

tien

t sa

fety

mat

eria

ls (

post

ers,

pat

ient

gui

de e

tc.)

wer

e av

aila

ble.

3.33

(0.

901)

6.

1 0.

7 14

.1

83.6

36

0

HCW

s al

low

ed m

e to

par

tici

pate

in m

y ow

n ca

re.

3.32

(0.

827)

4.

5 9.

6 35

.2

50.7

37

5

HCW

s ha

d en

ough

tim

e to

dis

cuss

my

care

with

me.

3.

29 (

0.90

2)

6.3

11.4

29

.1

53.1

42

9 F2

Pat

ien

ts a

bil

ity

to i

den

tify

pat

ien

t sa

fety

in

cid

ents

α=

0.78

0 3.

02 (

0.81

9)

I

felt t

hat

I w

as p

artly

resp

onsi

ble

for

the

safe

ty o

f m

y ow

n ca

re.

3.04

(0.

960)

9.

4 15

.5

36.2

38

.8

381

I

thin

k th

at I

am

cap

able

to

iden

tify

erro

rs in

my

care

. 2.

99 (

0.95

0)

9.2

17.6

37

.8

35.3

35

7

I th

ink

that

I a

m c

apab

le t

o id

entif

y ne

ar m

isse

s in

my

care

. 2.

94 (

0.95

3)

9.4

20.1

37

.5

33

339

F3 I

nfo

rmin

g p

atie

nts

ab

out

and

en

cou

rag

ing

par

tici

pat

ion

α

=0.

899

2.

87 (

0.86

7)

I

was

tol

d ho

w I

can

pro

mot

e sa

fety

of m

y ow

n ca

re w

ith

my

own

action

s.

3.13

(0.

975)

8.

8 15

30

46

.1

373

D

octo

rs e

ncou

rage

d m

e to

par

tici

pate

in d

ecis

ion-

mak

ing

rega

rdin

g m

y ca

re.

2.99

(0.

987)

10

.6

17.3

24

.5

37.6

35

9

Nur

ses

enco

urag

ed m

e to

par

tici

pate

in d

ecis

ion-

mak

ing

rega

rdin

g m

y ca

re.

2.97

(0.

976)

10

18

.9

34.9

36

.3

350

I

part

icip

ated

in d

ecis

ion-

mak

ing

rega

rdin

g m

y ow

n ca

re.

2.97

(1.

047)

12

.7

18.3

28

.6

40.5

37

8

I w

as g

iven

info

rmat

ion

abou

t pa

tien

t sa

fety

. 2.

57 (

1.11

3)

22.5

25

.4

25.1

27

37

4

I w

as t

old

how

to

act

if I

notice

an

erro

r or

nea

r m

iss

in m

y ca

re.

2.51

(1.

134)

24

.5

27.2

21

.2

27.2

36

8

37

Over a fifth of patients (21.9%) had experienced error(s) sometimes in their care and most of those (81.1%) had told someone about it when an error happened. In contrast, 58.1% reported that HCWs did not tell them about the errors that happened in their care and the errors were not handled with them in most (58.7%) of the cases. Moreover, only 31.9% had received an apology from HCWs about the error(s). Over half of the patients (54.4%) did not report the PSIs to the HCO where they were treated, 35.6% because they did not know what a PSI report is (Table 12).

Table 12. Error management with patients who had experienced error(s) sometime in their care I have

experienced error(s) sometime in my care? (n=440)

If you noticed an error in your care, did you tell anyone about it? (n=90)*

Did HCWs tell you about the error that happened? (n=93)*

Was an error handled with you? (n=92)*

Did you get an apology from HCWs? (n=91)*

Did you report the error to the HCO where you were in care? (n=90)*

% % % % % % Yes 21.9 81.1 41.9 41.3 31.9 10 No 48.6 18.9 58.1 58.7 68.1 54.4

Don´t know

30.5 (was not an option)

(was not an option)

(was not an option)

(was not an option)

(was not an option)

No, because I

don´t know

what a PSI report

is

(was not an option)

(was not an option)

(was not an option)

(was not an option)

(was not an option)

35.6

* Unpublished materials

5.2 FACTORS INFLUENCING INTERNAL MEDICINE PATIENTS’ PARTICIPATION IN PROMOTING PATIENT SAFETY

Multiple linear regression modeling was used to identify explanatory factors for patient participation, resulting in a significant regression equation: F (22, 367)=2990.254, p<0.001, with an R2 value of 0.994.

Statistically significant factors were found. Patients who were treated in hospital 2 (β=-0.016, p=0.040) and 3 (β=-0.021, p=0.008) participated to a lower extent than patients treated in hospital 1. Higher level of participation were expected for men (β=0.010, p=0.037) and patients who had (i) stayed in the hospital for 4–6 days (β=0.020, p=0.001), (ii) undergone 2–3 treatment periods of care during the recent year (β=0.017, p=0.003), (iii) exhibited high ability to identify PSIs (β=0.177, p<0.001), and (iv) positive experiences of medication safety (β=0.045, p<0.001). Likewise, significant positive regression weights were obtained for informing patients about and encouraging participation (β=0.319, p<0.001) and providing patients with necessary information in an understandable form in a timely manner (β=0.505, p<0.001). Therefore, patients who had better experiences were expected to have higher level of participation than those who had less favorable experiences. (Table 13). (Article IV).

38

Table 13. Results of multiple regression analysis of explanatory factors for patient participation

Variables B t p 96 % Cl Lower Upper

Gender Female ref. Male 0.010 0.008 0.037 0.001 0.020 University Hospital hospital 1 ref. hospital 2 -0.016 -2.064 0.040 0.031 -0.001 hospital 3 -0.021 -2.686 0.008 -0.036 -0.006 hospital 4 -0.003 -0.361 0.718 -0.019 0.013 hospital 5 0.014 1.823 0.069 -0.001 0.029 Length of stay 1–3 days ref. 4–6 days 0.020 3.475 0.001 0.009 0.031 7 days or more 0.012 1.836 0.067 -0.001 0.025 Number of in-patient treatment periods during the preceding year 0–1 ref. 2–3 0.017 3.010 0.003 0.006 0.027 4 or more 0.002 0.296 0.767 -0.012 0.017 Patient safety domains Informing patients about and

encouraging participation 0.319 75.769 <0.001 0.311 0.328

Providing patients with necessary information in an understandable form in a timely manner

0.505 71.862 <0.001 0.491 0.519

Patients’ ability to identify patient safety incidents

0.177 50.692 <0.001 0.170 0.184

Experiences of medication safety 0.045 7.407 <0.001 0.033 0.057

5.3 PATIENT-REPORTED PATIENT SAFETY INCIDENTS AND THEIR UTILIZATION IN HEALTHCARE ORGANIZATIONS

The data for this study were collected from 15 HCOs in Finland via the web-based error reporting database (HaiPro) from August 2009 to September 2015. The acquired database included 930 patients’ voluntary based reports, of which 690 had been completely analyzed and processed by the HCOs according to their routine procedures. After removing duplicates, test reports and reports that did not to relate patient safety, 656 of the 690 processed reports were included and analyzed in this study (Table 14). (Article III).

Patients had reported multiple kinds of PSIs, most frequently regarding information flow or its management (32.6%) and medications (18%). In most of the cases incidents were near misses (67.5%) and did not cause harm to patients (66%). In 3.2% of the patient-reported incidents serious harm was caused. Most frequent consequences for departments were image harm (54.6%) and extra work or minor treatment (23.9%). Financial harm was identified in only 2.9% of the reports (Table 14). (Article III).

39

Table 14. Summary of patient-reported PSIs (n=656)(n, %) n % Place of event Treatment room 103 15.7 Patient room 72 11 Patient home 41 6.2 Operating room 15 2.3 Corridor 14 2.1 Office 8 1.2 Scanning room 6 0.9 Lounge 5 0.8 Yard, outdoor area 5 0.8 Laboratory 4 0.6 Delivery room 3 0.5 Recovery room 2 0.3 Other 30 4.6 Not known 12 1.8 Not selected 336 51.2 Nature of the event Near miss 443 67.5 Happened to patients 213 32.5 Consequences for patients Unknown 32 14 No harm 433 66 Minor harm 66 10.1 Medium harm 71 10.8 Serious harm 21 3.2 Not selected 33 5 Event type Information flow or its management 239 32.6 Medication 132 18 Other treatment 125 17.1 Diagnosis-related 55 7.5 Operative treatment 44 6 Accident 40 5.5 Equipment or its use 25 3.4 Asepsis, hygiene 19 2.6 Laboratory test or medical imaging 16 2.2 Invasive treatment 12 1.6 Data protection or professional secrecy 8 1.1 Violence 7 1.0 Related to buildings 6 0.8 Emergency care context 3 0.4 Missing Patient 2 0.2 Consequences for department No harm 73 11.1 Image harm 358 54.6 Material harm 5 0.8 Financial harm 19 2.9 Extra work or minor treatment 157 23.9 Extended treatment 64 9.8 Table 14 to be continued

40

Table 14 continues Long-term treatment 0 0 Injury to personnel 2 0.3 Injury to other person 12 1.8 Not known 92 14

In 76% of the patients’ reports, they gave suggestions how the prevent reoccurrence such incidents which they have confronted. During the content analysis of those suggestions four themes were formulated (Table 15). Patients’ suggestions were feasible, mostly system-based amendments of processes for reviewing or administering treatment, anticipating risks or diligence in patient care. In addition, patients highlighted needs for adequate and skilled healthcare personnel and their collegial support for each other. (Article III). Table 15. Patients’ suggestions for preventing recurrence of patient safety incidents (n=503) (n, %) Themes n % Checking and reviewing the treatment process, risk management, and diligence in patient care

212 42.2

Adequate and skilled healthcare personnel and collegial support 137 27.2 Cooperation between patients, relatives, parents, and professionals 106 21.1 Safe healthcare environment 48 9.5 Altogether 503 100

Analysis of how those patients’ suggestions had been addressed in practice revealed that in most of the cases (76.7%) the HCOs’ analysts concluded that dissemination of information and discussion about the events was sufficient and in 10.5% of cases no measures were needed. The analysts recommended ‘Development measures’ in 9.6% of cases, but in 23 of those cases no implemented development measures were mentioned in the reports, despite notes that the PSI would be addressed in ward meetings, or a new approach would be considered. More detailed analysis showed that only 40 (6.1%) of the reports triggered actual development measures (Article III).

5.4 PATIENT SAFETY EXPERTS’ VIEWS OF PATIENT PARTICIPATION

Most of the PSEs (67%) had more than 4 years’ experience of patient safety work and 42% of them worked full time in patient safety-related activities. They were asked to evaluate their organizations’ patient safety levels and most (76.2%) rated it acceptable. None rated it excellent. In addition, two thirds (66.6%) stated that patients’ inclusion in the promotion of patient safety had been moderate or quite good, but the other third said this had been poor. Similar proportions were obtained for HCWs’ encouragement of patients to participate in the promotion of patients’ safety in their organizations (Table 16). (Article II).

41

Table 16. PSEs’ ratings of safety levels and patient participation in promoting patient safety in their organizations Evaluation of your organization's patient safety level from a patient safety expert perspective (n=21)

Evaluation of patients’ inclusion in the promotion of patient safety in your organization (n=21)

Evaluation of your organization’s staff’s encouragement of patients to participate in the promotion of patient safety (n=21)

% n % n % n 1=Not acceptable 0 0 1= Very poor 0 0 1= Very poor 0 0 2=Poor 9.5 2 2= Quite poor 33.3 7 2= Quite poor 47.6 10 3=Acceptable 76.2 16 3= Moderate 57.1 12 3= Moderate 42.9 9 4=Very good 14.3 3 4= Quite good 9.5 2 4= Quite good 9.5 2 5=Excellent 0 0 5= Very good 0 0 5= Very well 0 0 Mean (SD)

3.04 (0.498)

2.76 (0.625)

2.62 (0.669)

PSEs’ views of the patient’s role in promoting patient safety. PSEs considered patients’ roles in promoting patient safety as important, but limited in practice and stated that it has not reached the level demanded by current laws and strategies. However, PSEs also expressed views that patients’ roles should not be over-emphasized to avoid patients feeling too much pressure and responsibility. PSEs felt that to make informed decisions patients need reliable, comparative and publicly accessible information, which is currently lacking. They identified multiple factors that influence participation (e.g. patients’ personalities, motivation, interest in participation, trust in the healthcare professionals, attitude towards participation generally, age, spoken language, health status, cognitive ability, and education level). PSEs stated that healthcare culture is still quite traditional and there are inconsistencies in willingness to deal with issues raised by patients. They also emphasized that HCWs’ attitudes strongly influence the effectiveness of patient participation and suggested a need for basic and continuing education for HCWs in patient safety. (Article II).

Methods to promote patient participation. PSEs described multiple kinds of approaches for enabling patients to promote patient safety, such as establishing customer panels or patient councils for elderly and handicapped patients, and enabling patients to act as experience experts at organizational level. At individual level, patients have been involved by encouraging use of medication cards, which they maintain and carry, and engaged in the entire medication process, from arrival at the hospital to discharge. A few PSEs stated that patients have also been involved in the use of surgical checklists and through surveys related to patient safety and/or satisfaction with provided services. PSEs regarded involving patients in device safety as challenging, and the only one way they recognized that patients could potentially assist in their own device-related safety was by monitoring alarms. (Article II).

Patient participation in PSI management. PSEs’ views of patient participation in PSI management in their organizations varied considerably, from no patient involvement at all or no opportunity to participate, to full engagement in the whole process ending up with an apology. (Article II).

42

5.3 SUMMARY OF THE STUDY RESULTS

The findings of the studies this thesis is based upon include insights regarding patients’ experiences related to their safety and patient participation during their most recent period of care, PSEs’ views of patient safety in their organization and patient participation, and PSI reports, based on voluntary submissions by patients in the national database (Figure 3). Generally, patients felt safe during their care, and they trusted that HCWs did their best to ensure patients’ safety. Patients’ ratings of safety levels varied among hospitals and PSEs were more critical than patients when assessing safety levels of their organization. The results showed that patients’ participation is influenced by several factors. Patient-related factors (such as age, vocation, or gender) did not explain as much variance in patient participation in patient safety as HCW-related factors (such as encouragement and providing patients with necessary information promptly and comprehensibly). The studies also reveal that patients do not receive sufficient support and encouragement from their HCWs to participate in their own care and safety while in hospital.

PSEs identified many required improvements, e.g. changes in patient safety culture to increase support for patient participation, improvement in HCWs’ knowledge of patient safety and development of PSI management practices together with patients. Patients have reported multiple kinds of PSIs, most of which did not cause any harm to patients. They also suggested multiple, very feasible and system-based actions for preventing recurrence of PSIs they had encountered, but only a few of those suggestions led to actual development measures in HCOs.

Figure 3. Summary of the main results of the studies

• Patients felt safe during care and rated safety levels “very good” or “excellent”

• Patients who had encountered errors rated safety levels lower than patients who had not encountered errors

• Patients’ ratings of safety levels varied among hospitals

• Patients trusted HCWs to do their best to ensure safe care and use of medical devices

• Patients trusted that they were given the right medications, but 63% of patients took all medicines without asking what they were

• PSEs rated safety level in their organizations as “acceptable”

• PSEs regarded patients as having a crucial role in promotion of patient safety

• 48% of the PSEs rated the HCWs’ encouragement of patient participation as “quite poor” and 43% as “moderate” in their organizations

• Patients need reliable, comparable and publicly accessible information to make decisions

• Patient safety culture regarding patient participation is traditional

• Appropriate HCWs’ attitudes and actions are crucial for effective patient participation

• HCWs’ patient safety knowledge needs improvement

• Multiple factors influence patient participation

• HCWs’ willingness to deal with issues raised by patients varied considerably

• PSI management varied among HCOs

• There were variations across hospitals in level of patient participation

• Patients rated treatment experiences and device safety most positively, and HCWs informing them about and encouraging their participation most negatively

• Patient-related factors (such as age, vocation, or gender) explained less variance in patient participation in patient safety than HCW-related factors (such as encouragement, and providing patients with necessary information promptly and comprehensibly).

• Patients’ ability to identify PSIs and positive experiences with medication safety were positively correlated with participation

• Patients reported not receiving enough support and encouragement from their HCWs to participate in their own care and patient safety while in hospital.

Experiences of patient safety

• Patients suggested measures to prevent recurrence of two thirds of reported PSIs

• Suggestions were feasible, mostly system-based amendments of processes, but risk prevention and management and diligence of patient care were also highlighted

• Only 6% of patients’ reports triggered actual development measures in the organizations

• Patients described multiple kinds and severities of PSIs, but most of them did not cause any harm to patients

• Roughly two-thirds of PSIs were near-misses and the rest happened to patients

• Almost a third of PSIs were related to information flow or its management and almost a fifth of PSIs concerned medication

• In most cases patients were not involved in handling the errors and received no apology

Patient participation in patient safety

Patients’ incident reporting

Patients´views PSEs´ views

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6 Discussion

6.1 DISCUSSION OF THE STUDY RESULTS

In the studies underlying this thesis patient views of patient safety and their participation to promote patient safety were examined using three kinds of data: patient surveys, patients’ voluntary incident reports from the HaiPro database and a survey of Finnish patient safety experts’ views. This is the first time that PSI reports, based on voluntary submissions by patients, have been studied at national level in Finland, providing a unique perspective of Finnish patients’ views of PSIs and their suggestions for preventing similar events.

6.1.1 Patients need constant support and encouragement from healthcare workers Patients rated patient safety level mostly as very good and felt safe during their care. This

result is in line with Eurobarometer (2014) findings that most Europeans (71%) and 94% of Finnish people think that healthcare in their country is good and that patients are unlikely to be harmed by hospital care. However, approximately one in five of the internal medicine patients rated the safety level as less than good, which is also consistent with Eurobarometer findings (2014). The PSEs surveyed in Study II were more critical of the patient safety level in their organizations than the patients, possibly because the PSEs had many years of experience of developing patient safety and, thus, an overall understanding of safety including PSIs, adverse events, safety systems and development measures that had been taken. Moreover, PSEs can compare their organizations’ status in these respects to both national and international counterparts, so they have much broader perspectives of organizations’ current and potential safety levels.

Patients’ ratings of safety level varied among hospitals and were also influenced by their personal experiences of error(s): patients who had not encountered errors rated safety levels as “excellent” or “very good” more frequently than patients who had encountered error(s).

This could be due to associated differences in patients’ overall trust in HCWs, although most patients trusted HCWs to ensure safety of their care and to give the right medications during the care. Further, roughly 60% of patients took all medicines they were given without asking what they were. Confidence is essential in patient-provider relationships, but this raises questions about whether patients can trust HCWs and HCOs too much and where is the point where trust becomes blind, when we are aware of the amount of patients being harmed by healthcare?

Although patients generally regarded safety as very good, a fifth reported having encountered error(s) sometimes in their care. This is higher than frequencies of adverse events (9.2-17%) found in several international studies (deVries et al. 2008, Jha et al. 2010, Nunõ et al. 2015, Rafter et al. 2017, Zsifkovits et al. 2016). However, comparing these adverse events rates is difficult because of differences in data gathering procedures; some are based on patients’ records (e.g. Rafter et al. 2017) or systematic reviews (e.g. deVries et al. 2008, Guijarro et al. 2010, Ward & Armitage 2012) while others are based on patient surveys (e.g. Eurobarometer 2014, Fowler et al. 2008), which usually yield higher rates. Another factor is that patients generally have broader perceptions of safety than healthcare professionals (Davis et al. 2013, Harrison et al. 2015, Lang et al. 2016, Rathert et al. 2011).

The findings revealed that informing patients about and encouraging their participation, providing patients with necessary information in an understandable form in a timely manner, patients’ ability to identify PSIs, and positive experiences of medication safety were the strongest participation-promoting factors. Thus, patients who had positive experiences in these

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safety domains reported higher levels of participation than those who had negative experiences. Overall, patients rated treatment experiences and device safety most positively, and HCWs informing them about and encouraging their participation most negatively. Patients indicated that nurses (28,9%) and doctors (27,9%) did not encourage them to take part in decision-making. One reason for this may be poor communication by their HCWs, as use of medical jargon reduces patients’ participation in treatment (Hovey et al. 2010, Longtin et al. 2010, Pennbrandt 2009, Walrath & Rose 2008). Despite the lack of encouragement, patients were quite satisfied with obtaining the necessary information in an understandable form and a timely manner from the HCWs. This finding is consistent with previous findings that information sharing is appreciated by patients and important for successful patient participation (Redley et al. 2018, Sahlsten et al. 2008), and that sharing helps patients and improves patients’ experience by making them feel engaged, informed, and respected (Jangland & Gunningberg 2017, Tobiano et al. 2015a). Previous studies show that information-sharing, the foundation of patient participation is not necessarily easy and HCWs might be reluctant to share information with patients (McTier et al. 2013). This is partly due to HCWs’ professional identities, which often involves knowing what is best for the patient, so sharing information with patients threatens the power that comes with their professional status (Lawton & Armitage 2012).

Patients’ dissatisfaction with HCWs’ encouragement is quite alarming, as both the studies presented here and previous studies have shown that encouragement by, and approval of, HCWs is crucial for promoting patient participation (Birks et al. 2011, Davis et al. 2011, Davis et al. 2013b, Longtin et al. 2010, Rainey et al. 2013, Schawappach & Wernli 2010). Moreover, improving HCW engagement in patient encouragement may also be conducive for treating chronic diseases that typically afflict internal medicine patients. Such treatment requires patients’ strong adherence to therapy and self-management, both of which are difficult to ensure (Motlagh et al. 2016). The results are also encouraging since higher levels of patient participation have been associated with better self-care behavior of patients with heart failure (Näsström et al. 2014), diabetes and chronic kidney disease (Zimbudzi et al. 2017), which are common diseases of internal medicine patients (WHO 2014). Furthermore, in addition to their adverse effects on patient health and quality of life, chronic diseases are major drivers of healthcare costs. Hence, improving patient adherence to care and capacity for self-management may promote cost-effective healthcare (Iuga et al. 2014). From this perspective and based on results presented here, HCWs’ engagement in patient encouragement should be improved.

Interestingly, and adding to the existing literature, it appears that patient-related factors (such as age, vocation, or gender) explain less variance in patient participation in patient safety than HCW-related factors (such as encouragement, and providing patients with necessary information promptly and comprehensibly). This finding, together with the patients’ reported lack of encouragement from HCWs, confirms that there is still a paternalistic culture in healthcare, especially at the patient direct care-level, although the patient's involvement is widely supported by various policies (Ocloo & Matthews 2016). So, there is a compelling need for cultural change. Patient-centered care is needed, where patients are seen as experts in their own care, with will and capabilities (Ringdahl et al. 2017). To foster this cultural change, leadership must be strengthened (Kristensen et al. 2016). However, HCOs often have many competing priorities and lack a quality improvement infrastructure and supporting values (Sutton et al. 2015), which can lead to patient safety being rarely raised in communications between patients and HCWs in everyday clinical practice (Martin et al. 2013). Thus, nurse leaders have a critical role to play in developing appropriate structures for supporting patient participation in patient safety (Fisher et al. 2018, Jangland et al. 2017, Thornton et al. 2017). If patient safety issues are not customarily addressed in the wards, patients are unsure of their roles and expected actions (Ocloo & Matthews, 2016). As recently concluded by Fischer et al. (2018), leaderships’ commitment to safety, support of employees, and resilience, as well as safety education and training all strongly influence patient safety.

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Like mentioned above and adding to the existing literature, patients’ positive experiences of medication safety explained higher level of participation in patient safety in this study. This may be because while medication errors are common across healthcare systems globally and mostly preventable, considerable effort has been expended in developing strategies to increase safety in medication use worldwide. Through various campaigns such as Speak Up and Think Safe patients’ understanding has increased and concrete tools, such as patient logbooks, have been developed to ensure patient medication safety. Previous studies have shown that patients usually play the role of “vigilant monitor” (which is relevant in preventing medication errors) for example, by querying doses (Hall et al. 2010, Rainey et al. 2103, Sutton et al. 2015). On the other hand, a previous study found that patient participation in medication management is jeopardized by nurses’ procedural task-orientated approach to the administration of medications, resulting in missed opportunities to educate and promote patient participation (McTier et al. 2013). Moreover, previous studies have found that meeting patients’ educational needs may be a frequently neglected aspect of nursing care (Ausserhofer et al. 2014), and patients may think that nurses have no interest in their contributions, because of the nurses’ task-oriented approach, causing patients to adopt a passive role (Flink et al. 2012).

Further, Mohsin-Shaikh et al. (2014) found that most patients and HCWs support involvement of hospital in-patients in their medication, but there is a significant gap between the desire for patient involvement and patients’ reported experience. In terms of patients’ medication self-management at least, it was encouraging to find out that almost all patients surveyed in Study II were fully aware of their medications when discharged from hospital. However, some patients still do not receive an up-to-date medication list when leaving hospital, although this would support self-care and ensure that patients have their current medication list at key times, for instance on admission to hospital.

Medical devices and healthcare technologies are integral elements of healthcare delivery and (for example) mobile technology and telehealth applications are changing the nature of provider-patient interactions. In addition, patients are using increasing numbers of medical devices in their homes, e.g. hemodialysis systems and patient-controlled analgesia (PCA) pumps. All medical devices are associated with a certain degree of risk and could cause PSIs in specific circumstances, for example 2683 people were reportedly killed or seriously injured in device-related adverse events in the UK in 2010 (Department of Health 2011). Patients surveyed in Study II noted that they were not always told about the medical devices used in their care, how they operated and what they should do if a medical device signaled an alarm. The Council of the European Union adopted new rules regarding the use of medical devices (from heart valves to sticking plasters) in April 2017 designed to improve the devices’ safety for the benefit of patients while preserving timely access to innovative healthcare solutions. The new EU rules also strengthen transparency of information for consumers, in efforts to ensure that vital information is easy to find, and that patients receive an implant card with all the essential information, and a unique device identifier (Council of the European Union 2017).

6.1.2 Underutilization of patient-reported patient safety incident data in healthcare organizations Patients reported 15 different types of PSIs, most of which were classified as pertaining to deficiencies in information flow, medication problems or inadequate patient monitoring. Most of them did not cause any harm to patients, and were classified as near misses. Few had serious consequences or posed either high or extreme risk, according to the HCOs. These results are consistent with previous findings that patients can report multiple types of PSIs (Armitage et al. 2017, Walton et al. 2017) and that most PSIs concern medication problems (Harrison et al. 2015, Ward & Armitage 2012), poor care co-coordination (Schwappach 2014), or healthcare process problems (Davis et al. 2013a), and the consequences are rarely serious or life-threatening (Daniels et al. 2012, Ward & Armitage 2012). The reliability of patients’ reports has been debated, as most patients are not medically trained and may therefore incorrectly attribute

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errors or overestimate their severity (Zhu et al. 2011). However, previous analysis of patients’ reports has indicated that most identified adverse events have also been classified as adverse events by physicians (Zhu et al. 2011) and the GTT method (Bjertnaes et al. 2015). Further, patients’ reports are potentially rich resources for learning and improvements (Harrison et al. 2015, King et al. 2010), as well as evaluating healthcare effectiveness and responsiveness (Doyle et al. 2013). In addition, patients can identify poor and unsafe practices (Doyle et al. 2013, Harrison et al. 2015), adverse events (Guijarro et al. 2010, King et al. 2010) and factors contributing to adverse events (Etchegaray et al. 2016). Moreover, patient experiences can be seen as early warnings of potential adverse events (Soutwick et al. 2015) rather than as excessively subjective or mood-orientated and divorced from ‘real’ clinical work (Doyle et al. 2013). It has also been noted that patients report many events that are not documented in medical records (Friedman et al. 2008, Weissman et al. 2008). Thus, patients’ reports of PSIs can complement reports from other sources with information that cannot be obtained from other sources (Lawton et al. 2015, Wright et al. 2016, Zhu et al. 2011) and thus facilitate efficient identification of effective interventions to promote patient safety. This is especially important for groups such as internal medicine patients, who are more frequently hospitalized than average patients and, hence, more likely to encounter safety incidents (Härkänen et al. 2015), so these patients must feel empowered and capable of speaking up about such incidents.

Almost one fifth of patients didn´t report PSI to the HCO were they were treated and over third (35,6%) of patients because they didn´t know what PSI report is. Accordingly, Eurobarometer (2014) showed that only about half of citizens who said they had experienced an adverse event reported it. Further, at the European level there has been an 18% increase in numbers of patients reporting an adverse event, while in Finland the reporting rate has decreased by 3% since 2009. In addition, there are huge differences in national reporting rates, ranging from 6% in Bulgaria to 65% in France.

There was clearly room for improvements in patients’ ability to identify errors and near misses. It was also found that patients’ ability to identify PSIs is an important explaining factors of better patient participation. These results are supported by previous findings that patients’ self-efficacy, i.e., the belief in their ability to complete tasks and attain goals, is an important enabler of patient participation in patient safety-related issues (Bishop et al. 2015, Davis et al. 2015). While patients may be aware of the barriers to and benefits of becoming involved in patient safety practices, they are less likely to become involved if they believe they have no influence on provider behavior (Bishop et al. 2015).

Over two thirds of patients who submitted the considered PSI reports gave various suggestions, mostly very practical and feasible, for preventing the kinds of PSIs they had encountered. Most patients’ proposals for preventing harm in the reports concerned system-level changes such as reviewing treatment processes, risk assessments and checklists, matching measures currently highlighted by healthcare development practitioners and researchers. In addition, one in five of them indicated that incidents could be prevented by better listening to patients, family members or parents, and improving co-operation between them and healthcare professionals. These results are consistent with previous findings (Ricci-Cabello et al. 2017, Soutwick et al. 2015) and the prevalent view of system-led development of patient safety (Carayon et al. 2014).

However, development measures triggered by patients’ suggestions were mentioned in surprisingly few of the reports (40 of 656), raising questions about why HCOs do not, apparently, exploit patients’ suggestions. There could be several reasons. First, previous studies on healthcare staffs’ views suggest that learning from PSIs might be quite challenging (Andersson et al. 2013, Mitchell et al. 2016), because incident reports do not provide unambiguous indications of ways to improve safety (Andersson et al. 2013). Second, some development measures that have been implemented may not have been entered in the reporting system, although the HCOs had finished processing every report included in the dataset. This suggests that there is substantial scope for improving the handling process in

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HCOs. Third, patient-reported PSIs provide a relatively new perspective in patient safety promotion, and patients have a broader view of PSIs than healthcare staff. Thus, patient-reported PSIs could be seen as general complaints that should not be taken seriously as critical incidents (Gallagher & Mazor 2015) and are easy to explain away. Fourth, despite the system-level orientation of most patients’ suggestions, in most cases HCOs’ analysts’ only proposal to prevent recurrence of PSIs was “to inform and to discuss about the incident”. Furthermore, most of the resulting discussions took place at the unit where the PSI had occurred, and rarely included other parties involved. Merely informing healthcare staff about PSIs is not enough to improve safety (Reeves et al. 2013), but this “easy response” may have been due to lack of dedicated time and resources for identifying causes of incidents and appropriate actions to prevent their recurrence (Andersson et al. 2013, Mitchell et al. 2016, Pham et al. 2013).

From an organizational learning perspective, the underuse of patients’ PSI reports may reflect weak absorptive capacity of HCOs, i.e., low ability to manage and process knowledge to improve performance (Gleeson et al. 2016, Harvey et al. 2015). As previously shown, if there is no culture of listening to patients, HCOs might fail to appreciate the scale of problems and/or react too slowly, if at all, to raised concerns (Francis 2013). Further, if reports are merely handled at unit level, the only attempts to correct or avoid mistakes may be minor fixes and adjustments that do not address root causes of PSIs, so similar PSIs may still occur elsewhere in the HCO (Harvey et al. 2015). Thus, this kind of single-loop learning, which incident reporting systems mainly stimulate (Stavropoulou et al. 2015), does not provide sufficient incentives to improve safety. Hence, it is important for HCOs to have other tools for monitoring safety on a day-to-day basis, in addition to monitoring harm, permitting early identification of problems so actions can be taken before they threaten patient safety. Patients’ perspectives can be added to this “sensitivity of operation”, for instance by inviting patients to participate in safety walk-rounds (Vincent et al. 2014).

Regardless of whether underuse of the PSI reports was due to one or all of these reasons, changes in patient safety culture, which does not always support learning from mistakes, are needed. For example, lack of transparency often leads to errors being swept under the carpet (Kachalia 2013). Previous studies have also suggested that there are challenges in every stage of the incident reporting process (not only consideration of patients’ reports), from reporting through investigation to implementation and evaluation of actions (Andersson et al. 2013). Requirements to tackle these challenges include adequate resources for analysis and follow-up actions (Andersson & Kodate 2015, Kohn et al. 2000, Mitchell et al. 2016) and support from leaders (Andersson & Kodate 2015, Ginsburg et al. 2010). Despite these challenges in incident reporting, it can and does trigger improvements in practice (Sujan 2015), leading to changes in care processes and both the attitudes and knowledge of HCWs (Andersson et al. 2013).

Study II revealed that incident management in collaboration with patients needs improvements, as over half of patients who encountered error(s) recorded that HCWs did not tell them about errors that happened and the errors were not handled with them. Further, only 31.9% of the patients had received an apology from HCWs about the errors. These findings confirm previously reported shortcomings (Birks et al. 2015, Eurobarometer 2014, Lyu et al. 2014, Ocloo 2010), although a consensus has been reached regarding the ethical duty to communicate openly with patients who have been harmed by medical errors (ACSQHC 2013, Birks et al. 2014, Gallagher 2013, Kachalia & Bates 2014,). Open disclosure in clinicians’ communication with and support of patients have experienced harm during healthcare, as well as their families and carers (ACSQHC 2013), is often also regarded as an essential element of the transparency required to increase patient trust and foster a stronger culture of safety (Kachalia & Bates 2014). It has also been found that implementation of disclosure programs decreases frequencies of claims and lawsuits (Kachalia et al. 2010, Kachalia & Bates 2014). However, many physicians struggle to meet this responsibility (Birks et al. 2014, Gallagher et al. 2013). The biggest barriers to full disclosure are fear of litigation, difficulty of admitting that an HCW has harmed patients, and lack of knowledge and training to conduct challenging conversations

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(Birks et al. 2014, Harrison et al. 2014). For nurses, inter-professional communication, hierarchical practices, and fear of punishment or unfair treatment by managers have also been identified as barriers (Harrison et al. 2014). However, patients want to be informed immediately of what and how an error happened and measures that could have been taken to prevent it (Bismark 2009). They also expect to receive an apology (Guijarro et al. 2010, Iedema et al. 2012, Piper et al. 2014). Disclosing medical errors with patients can help frontline clinicians to learn ‘first-hand’ from patients’ experiences, and patients can also learn from clinicians how to be better partners in safety promotion in ways that are not otherwise accessible to them in routine healthcare settings (Langer et al. 2016).

6.1.3 Patient safety experts highlighted the patients’ role in promoting patient safety PSEs recognized the importance of the patient’s role in promoting patient safety and emphasized that patients’ experiences should be considered more carefully when promoting patient safety. Similarly, the Patient Experience Book (2013), published by the UK’s National Health Service, emphasizes the importance of designing services to improve patients’ inputs and experiences by listening to patients’ and families’ needs, then utilizing the skills and expertise of both the clinician and patient to design experiences to meet these needs. However, most of the PSEs surveyed in Study IV said that in practice the patient’s role varies and does not always meet standards stipulated in the Finnish Healthcare Act (MSAH 2010) and patient safety strategy (MSAH 2009).

The PSEs strongly emphasized that appropriate healthcare professionals’ attitudes are crucial for effective patient participation in promotion of patient safety. Further, they saw that prevailing patient safety culture is quite traditional and does not sufficiently support patient participation. These results are consistent with previous findings that HCWs’ encouragement is crucial for patients (Davis et al. 2013b, Entwistle et al. 2010, Longtin et al. 2010, Martin et al. 2013, Schwappach 2010, Tobiano et al. 2015a, WHO 2013) and a lack of encouragement inhibits patient participation (Eldh et al. 2006). Martin et al. (2013) also found that patient participation in patient safety is not prominent in daily practice in hospital wards and that there were no strategies or interventions with a specific focus on systematic patient participation.

The PSEs reported a lack of national and institutional standards for involving patients in their care, and stressed the need for nationally consistent patient safety indicators. They also lauded the patients’ freedom to choose their own treatment sites, but acknowledged that the ability to make informed decisions requires reliable, comparative, and publicly accessible information, which is currently lacking, as are nationally standardized patient safety indicators. In addition, PSEs called for better dissemination of best patient safety practices. Recognition of the need for reliable, comparative and publicly accessible information is widespread internationally. However, it is particularly prominent in Finland, where one of the biggest national health, social services and regional government reforms is in preparation. This will substantially expand patients’ freedom of choice, and (inter alia) give patients faster access to care and improve their opportunities to influence the services they use in different life situations (MSAH 2017a). These are key issues that must be actively addressed, because to make rational and safer choices about their care patients need reliable, comparative information on the safety of organizations and services (Viktoor et al. 2012b, Vincent & Coulter 2002, Wahlstedt & Ekman 2016). To enable patients to compare providers across a set of “quality indicators”, and choose providers, internet-based systems have been developed, such as “open comparison (öppna jämförelsen)” in Sweden and NHS Choices in the UK. However, patients do not always seem to make choices based on comparative information. Instead, their choices are often influenced more by their previous healthcare experiences or complex interactions between diverse patient and provider characteristics, such as distance, convenience of location and/or physicians’ communication styles (Viktoor et al. 2012a). Main barriers to the use of comparative information include unavailability of the right information, distrust of the information,

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information overload and insufficiently clear presentation of the information (Wahlstedt & Ekman 2016).

Although internet-based information sources are widely available and among the most important sources of relevant health information, there are several issues associated with providing patients with health information over the internet. Wahlstedt & Ekman (2016) found that relatively few people appear to use the internet as a source of healthcare information and that the demands for and use of web-based sources are largely dependent on individuals’ socioeconomic status, age and health status: patients who were female, less than 60 years old and highly educated patients used them more than those who were male, older and less educated. Dixon et al. (2010) found that only 8% of patients surveyed in the UK had used the internet to find health information and only 4% had used the government-funded site “NHS choices”, created specifically to help NHS patients make choices.

The PSEs who participated in Study IV recommended increasing basic and continuing education in patient safety, and efforts to change HCWs’ attitudes, promote multi-professional collaboration and create an open atmosphere to establish and maintain patient safety. These recommendations are supported by previous findings that patient safety training, learning from PSIs, and practicing skills in professional groups in simulation environments are rare in Finnish nursing education (Tella et al. 2015b) and fair open, multiprofessional learning environments with a systems approach are rare in Finnish HCOs (Tella et al. 2015a). Moreover, previous studies have found that there is insufficient knowledge, a lack of knowledge, or deficits in knowledge related to patient safety among HCWs (Brasaite et al. 2016, Flotta et al. 2012).

6.2 DISCUSSION OF THE LIMITATIONS AND STRENGTHS OF THE STUDY

Two types of data were collected: register data (HaiPro) and survey data, both of which have specific limitations and strengths, which should be considered when interpreting results of this study.

Some limitations are common for the register study. First, the data used in this study were not collected for research purposes, because they were primarily intended to enable organizations to develop their services and the quality and safety of patient care. Therefore, the data were not systematically collected over time and the documentation may have been incomplete. In addition, the analysis of patients’ reports was largely based on HCO analysts’ classifications (which were only changed if those analysts had chosen “other” or “not known” incident types). It is also possible that there are inconsistencies between HCOs analysts how patients’ PSI reports are handled and classified, and like previous studies suggest, there are challenges of analyzing incidents because lack of dedicated time and resources (Andersson et al. 2013). Another limitation is that only patient-reported PSIs were examined, so insights gained were restricted to views of patients who were familiar with the reporting system. Further, patients’ reports may be biased by reluctance to report problems they experience with those responsible for their care. However, we must recognize that we will never be aware of all the PSIs experienced by patients. So, a combination of underreporting by some patients and overreporting by others may have affected the results.

On the other hand, patients’ perceptions and experiences may provide indications that powerfully complement information from other sources about system quality and enable identification of potential target areas for development. Self-reports also provide opportunities to explore patients’ perceptions of their care and the health system in collaborative reflective dialogue. Finally, generalization of the results needs to be carefully considered due to the abovementioned limitations, but many of the results are corroborated (and thus support) findings of previous international studies.

Two major strengths of this study is that this is the first nationwide study based on a sample of reports covering six years from all the HCOs that had introduced a patients’ voluntary web-

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based error-reporting system in Finland and the data are from reports with detailed information given by patients and relatives themselves.

Limitations regarding surveys and the development of the PEPS questionnaire should also be noted. First, the development of the PEPS questionnaire was based on literature review and although search terms and words were processed in collaboration with the University of Eastern Finland´s information specialist, and numerous articles were retrieved, some relevant articles may not have been identified. Second, the term "error" was used to describe problems or anomalies of treatment-, device-, and medication safety, and patient participation, as the term “adverse event” is not well-known among patients (Blendon et al. 2002, King et al. 2010), but there is no consensus on the best terminology to use when speaking with patients about errors in care (King et al. 2010). Third, the concepts of patient participation, error or near misses were not defined in the questionnaire. Thus, patients’ concepts of those terms may also have varied, potentially leading to some inconsistency across the sample, particularly as patients’ views of adverse events and quality of care are usually broader than official definitions (Jorm et al. 2009, Peat et al. 2010, Rathert et al. 2011). Fourth, the PEPS questionnaire was purposefully designed for this study because there were no other available tools for measuring patients’ views of participation. However, the validity and reliability of the new PEPS instrument were ascertained in many phases (Burns & Grove 2009). The questionnaire’s content validity was supported by its initial foundations in the literature review, Finnish Patient Safety Strategy (MSAH 2009) and conceptual model of factors that influence patient participation in preventing errors presented by Longtin et al. (2010). Further, four national PSEs and five patients evaluated the relevance of items and the whole questionnaire. Construct validity was examined with Principal Component Analysis (PCA) with varimax rotation in both phases of the study. When exploring patients’ general views of patient safety, in phase I, PCA revealed eight factor solution, explaining 68.3% of the variance. In phase II when exploring patients’ reported experiences of patient participation in promoting patient safety during their last treatment period revealed three factor solution, explaining 68.3% of the variance (Grove et al. 2013, 566-569). As a new questionnaire, the PEPS showed good internal consistency (see details in Chapter 4.2 and 4.3). Fifth, the survey response rate was 36.4%, which can be considered quite low, and restricting participants to those who could self-complete the questionnaire may have reduced the number of respondents, preventing access to views of patients who were too ill or unwilling to participate. However, power analysis showed that the gathered dataset was of acceptable size for the analytical methods used. In addition, the data covered the studied hospitals quite evenly and, hence, none were over- or under-represented. Sixth, there is limited scope for generalization of the results, because the data were collected over a specific time period and in one country, which are general limitations in all cross-sectional studies. Therefore, it is possible that aspects related to culture or time period may have impacted the results.

PSEs’ views on patient participation in promoting patient safety were also acquired with a purposefully developed questionnaire and interviews. The surveyed PSEs represented PSEs from diverse HCOs scattered across Finland, offering new insights into PSEs’ views of patient participation, which should facilitate further development of patient safety nationally. Furthermore, the PSEs’ replies were diverse, but data saturation was obtained, implying that rich and meaningful data that are relevant to the study’s aims were acquired (Graneheim & Lundman 2004, Grove et al. 2013). There is limited scope to generalize the results (like those of the patient survey), because the data were collected over a specific time period, in one country, and patient safety regimens are being developing in many projects in numerous HCOs. However, although the respondents did not include all Finnish PSEs, the saturation of the data and consistency of the findings with previous international studies (strengths of the study) indicate that the results have substantial transferability to settings in other countries.

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7 Conclusions and recommendations

The studies this thesis is based upon generated new knowledge about patient participation in the promotion of patient safety using patient-reported patient safety incident reports, patient safety experts' views of patient participation and patients' experiences of safety during their most recent period of care. The following conclusions can be drawn from the results.

1. Although patients’ views of patient safety are generally positive, every aspect of patient safety needs further development. Importantly, patients do not receive enough support and encouragement from their HCWs to participate in promoting patient safety while in hospital. Therefore:

o Leaders and nurse managers at all levels must create an environment where patient participation can occur and thus act as a facilitator of patient safety.

o It is crucial for leaders and managers to have competence to lead patient safety and patient participation in promoting patient safety programs and this should be included in their job descriptions.

o Leaders and managers should ensure that patients’ participation is valued and adequately resourced in HCOs and that HCWs have enough time to involve patients in their own care.

o Patients should be seen as experts about their own care, with their will and capabilities.

2. Patients report diverse types and severities of PSIs and suggest practical systems-based

solutions to prevent recurrence of similar types of PSIs, but few of their reports lead to development measures in HCOs. Therefore:

o Patient-reported PSIs provide information about patient safety that cannot be readily acquired from other sources. Therefore, HCOs should incorporate them into their current mechanisms for measuring, monitoring and managing risks as part of their safety management programs.

o Patient incident reporting provides valuable and supportive information about inconsistencies and PSIs in care, so patients should be encouraged to report detected deficiencies and errors more actively. Reporting should be easy.

o There is urgent need to ensure that patients’ PSI reports are taken seriously in HCOs, as well as other data sources that can be used to improve safety and quality of care.

o Patients still need targeted education and training for identifying errors and near misses and ways to report them.

o Patient safety learning outcomes should be included in healthcare professionals’ curricula so that future workforce achieves the needed PS competences.

3. There are deficiencies in PSI management with patients. Not all HCOs had either any or

a systematic approach to handle those errors with patients or their relatives. Therefore: o It is crucial for HCOs to develop systematic ways to handle errors with patients,

because patients can offer insights that HCWs may lack. Patients appreciate and need errors to be handled with them, to regain trust in HCWs and move on in their lives.

o To promote PSI management, HCWs and leaders need advice and training in order to participate in open disclosure, but more importantly they need an organizational culture that discourages attribution of blame.

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4. The importance of patient participation in promoting patient safety is recognized, but

traditional patient safety culture still restricts patient participation. Therefore: o HCWs and patients should have a shared understanding of the meaning and

means of patient participation, which should be systematically, applied across all patient safety practices.

o Further education for both patients and HCWs is needed, which could strengthen the patient’s role and help create an open, fair patient safety culture in which the patient is seen as an equal partner in the promotion of high-quality and safe care.

o Patients need support and encouragement from HCWs to participate in their own care and to promote patient safety.

o Organizational and cultural changes are crucial for promoting patient participation in healthcare, and strong leadership is required to achieve these changes. Transformational leadership would be a successful means for developing a safety culture where patients are considered co-producers of patient safety.

5. There is a need for national unified and comparative patient safety indicators that could be used by patients and HCOs to compare, evaluate, and improve the quality and safety of care. Therefore:

o Patient safety and its development should be coordinated nationally through a patient safety strategy that provides practical guidelines for development of patient safety and highlights its implementation in practice

Recommendations for further research

The presented studies suggest that there are deficiencies in patient participation and therefore further research is of high priority.

1. These studies included explorations of hospitalized patients’ experiences of safety, but increasing numbers of patients are being treated in their homes, so it would be highly beneficial to study home care patients’ views of patient safety, their participation in it, and the effect of the home environment on their views.

2. The presented analysis of patients’ incident reports was based on the reports’ treatment by

analysts in HCOs, so it would be interesting to reanalyze the reports and find out if there are inconsistencies in their handling, as literature suggests.

3. In Finland, major health and social services reform are currently in progress. It would be

beneficial to study the kinds of indicators that patients need, how they could be provided, and their conceptions of using the indicators while exercising their freedom of choices.

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Waterman, A., Gallagher, T., Garbutt, J., Waterman, B., Fraser, V. & Burroughs, T. (2006) Brief Report: Hospitalized patients’ attitudes about and participation in error prevention. Journal of General Internal Medicine, 21 (4), 367–370.

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1/12

App

endi

x 1.

Stu

dies

exa

min

ing

the

patien

t pa

rtic

ipat

ion

in p

rom

otin

g sa

fe c

are

(n=

58)

Au

thor

(s),

(y

ear)

, co

un

try

Pu

rpos

e an

d a

im(s

) of

th

e st

ud

y D

esig

n,

met

ho

d(s

),

sam

ple

R

esu

lts

And

erss

on

et a

l. (2

015)

, Sw

eden

To e

xam

ine

adve

rse

even

ts in

nu

rsin

g ca

re a

s th

ey a

re

expe

rien

ced

by p

atie

nts

and

rela

tives

.

Retr

ospe

ctiv

e st

udy.

A

qual

itativ

e an

d a

quan

titat

ive

appr

oach

. 24

2 pa

tient

and

rela

tives

re

port

ed a

dver

se e

vent

s.

Patie

nts

and

rela

tives

repo

rt e

xper

ienc

es o

f adv

erse

eve

nts

in re

latio

n to

lack

of

part

icip

atio

n, c

linic

al ju

dgem

ent,

nurs

ing

inte

rven

tions

and

ess

entia

ls o

f car

e,

even

ts th

at h

ave

led

to b

oth

phys

ical

and

men

tal i

njur

ies.

Ove

r one

thir

d of

the

adve

rse

even

ts re

port

ed b

y pa

tient

s, o

r rel

ativ

es’ c

once

rn la

ck o

f par

ticip

atio

n.

Nur

ses

need

to im

prov

e th

eir s

kills

that

sup

port

pat

ient

par

ticip

atio

n an

d it

need

s to

be

inco

rpor

ated

into

nur

ses’

dut

ies.

Ba

rtlo

va e

t al

. (20

14),

Cze

ch

Repu

blic

To e

xam

ine

the

exte

nt to

w

hich

pat

ient

s ar

e in

volv

ed in

de

cisi

ons

pert

aini

ng to

the

care

pr

ovid

ed a

nd w

heth

er th

ey a

re

inte

rest

ed in

par

ticip

atin

g sa

fety

issu

es d

urin

g ho

spita

lizat

ion.

Stru

ctur

e in

terv

iew

s us

ing

a Su

rvey

Net

wor

k IN

RES

to 5

14 p

atie

nts.

54.0

% o

f pat

ient

s vi

ewed

the

oppo

rtun

ity fo

r pat

ient

s or

thei

r fam

ilies

to d

iscu

ss

the

safe

ty o

f the

pro

vide

d ca

re a

s po

sitiv

e. M

any

patie

nts

wer

e un

awar

e of

wha

t th

e sa

fety

of t

he p

rovi

ded

care

invo

lves

, and

they

did

not

feel

qua

lifie

d to

dis

cuss

it.

Ove

r hal

f of p

atie

nts

expr

esse

d a

will

ingn

ess

and

desi

re to

par

ticip

ate

mor

e in

de

cisi

ons

abou

t the

ir tr

eatm

ent,

but 2

7.5%

of p

atie

nts

wer

e no

t int

eres

ted

in

grea

ter i

nvol

vem

ent.

73.5

% o

f pat

ient

s sa

id th

ey w

ould

not

hav

e th

e co

urag

e to

as

k m

edic

al s

taff

(doc

tors

or n

urse

s) w

heth

er th

ey h

ad w

ashe

d th

eir h

ands

pri

or

to e

xam

inat

ion.

Be

rger

et a

l. (2

014)

, USA

To

exa

min

e ho

w in

terv

entio

ns

enco

urag

ing

enga

gem

ent h

ave

been

impl

emen

ted

in

cont

rolle

d tr

ials

.

A s

yste

mat

ic re

view

, 12

stud

ies.

D

efin

ition

s of

pat

ient

and

fam

ily e

ngag

emen

t wer

e la

ckin

g, a

s w

ell a

s ev

iden

ce

rega

rdin

g th

e ty

pes

of p

atie

nts

who

mig

ht fe

el c

omfo

rtab

le e

ngag

ing

with

pr

ovid

ers,

and

in w

hat c

onte

xts.

Whi

le p

atie

nt e

ngag

emen

t in

safe

ty is

an

appe

alin

g ap

proa

ch, t

here

is s

till l

ittle

evi

denc

e re

gard

ing

the

part

icul

ar d

etai

ls o

f im

plem

enta

tion.

Bi

rks

et a

l. (2

011)

, UK

To

inve

stig

ate

how

pat

ient

s,

thei

r fam

ily m

embe

rs a

nd

othe

r rep

rese

ntat

ives

mig

ht b

e in

volv

ed in

thei

r hea

lth c

are

to

prom

ote

thei

r ow

n sa

fety

Thre

e m

ain

phas

es o

f w

ork:

1) l

itera

ture

revi

ew

2) p

atie

nts

indi

vidu

al

inte

rvie

ws

and

focu

s gr

oups

3) t

he

deve

lopm

ent a

nd p

ilotin

g of

pat

ient

invo

lvem

ent

stra

tegy

Part

icip

ants

sug

gest

ed th

at c

hang

es in

soc

iety

and

hea

lthca

re c

ultu

re in

rece

nt

deca

des

shou

ld m

ake

it ac

cept

able

for p

atie

nts

to a

ssum

e a

mor

e ac

tive

role

in

ensu

ring

they

rece

ive

safe

car

e. T

here

was

a w

ides

prea

d pe

rcep

tion

that

he

alth

care

pro

fess

iona

ls d

o no

t, in

gen

eral

, wel

com

e pa

tient

s sp

eaki

ng u

p. It

is

impo

rtan

t tha

t hea

lthca

re p

rofe

ssio

nals

and

bro

ader

hea

lthca

re s

yste

ms

supp

ort

patie

nt in

volv

emen

t in

enha

ncin

g sa

fety

. Nur

ses,

as

the

larg

est h

ealth

pro

fess

iona

l w

orkf

orce

and

thos

e w

ith m

ost c

onta

ct w

ith p

atie

nts,

are

wel

l pla

ced

to s

uppo

rt

this

. Bi

shop

et a

l. (2

015)

, C

anad

a

To u

nder

stan

d w

heth

er p

atie

nt

perc

eptio

ns o

f pat

ient

saf

ety

play

a ro

le in

pat

ient

in

volv

emen

t in

fact

ual a

nd

chal

leng

ing

patie

nt s

afet

y pr

actic

es a

nd w

heth

er th

e co

nstr

ucts

of t

he H

ealth

Bel

ief

Mod

el h

elp

to e

xpla

in s

uch

perc

eptio

ns.

Part

ial l

east

squ

ares

an

alys

is o

f dat

a. S

urve

y of

21

7 pa

tient

s fr

om fo

ur

inpa

tient

uni

ts lo

cate

d in

tw

o ho

spita

ls.

Patie

nts

wer

e m

ore

likel

y to

eng

age

in fa

ctua

l pat

ient

saf

ety

prac

tices

than

ch

alle

ngin

g pa

tient

saf

ety

prac

tices

. Sel

f-effi

cacy

was

foun

d to

be

a m

edia

ting

fact

or b

etw

een

perc

eptio

ns o

f bar

rier

s an

d be

nefit

s an

d pa

tient

invo

lvem

ent,

sign

alin

g th

is to

be

an im

port

ant p

erce

ptio

n en

ablin

g pa

tient

s to

take

act

ion.

2/12

A

uth

or(s

),

(yea

r),

cou

ntr

y

Pu

rpos

e an

d a

im(s

) of

th

e st

ud

y D

esig

n,

met

ho

d(s

),

sam

ple

R

esu

lts

Bish

op &

M

acdo

nald

(2

017)

, CA

N

To d

escr

ibe

patie

nt

invo

lvem

ent i

n pa

tient

saf

ety

prac

tices

by

expl

orin

g pa

tient

an

d nu

rsin

g st

aff p

erce

ptio

ns

of s

afet

y.

Focu

s gr

oups

wer

e co

nduc

ted

with

a

conv

enie

nce

sam

ple

of

nurs

ing

staf

f (n=

27) a

nd

patie

nts

(n=1

0).

Four

them

es w

ere

iden

tifie

d: (1

) wan

ting

cont

rol,

(2) f

eelin

g co

nnec

ted,

(3)

enco

unte

ring

road

bloc

ks, a

nd (4

) sha

ring

resp

onsi

bilit

y fo

r saf

ety.

The

impo

rtan

ce

of b

uild

ing

a pe

rson

al c

onne

ctio

n as

a p

recu

rsor

to e

nsur

ing

that

pat

ient

s ar

e in

volv

ed in

thei

r car

e an

d sa

fety

was

hig

hlig

hted

by

patie

nts

and

nurs

ing

staf

f. Th

e fo

cus

grou

p re

sults

als

o re

veal

ed th

at b

oth

wor

kloa

d an

d co

mm

unic

atio

n m

ay b

e cr

itica

l fac

tors

inw

hy s

ome

patie

nt in

volv

emen

t str

ateg

ies

are

not w

idel

y ad

opte

d by

nur

sing

sta

ff.

Bret

t et a

l. (2

014)

, UK

To

iden

tify

the

impa

ct o

f pa

tient

and

pub

lic

invo

lvem

ent o

n he

alth

and

so

cial

car

e re

sear

ch.

A s

yste

mat

ic re

view

, 66

stud

ies.

The

posi

tive

impa

cts

iden

tifie

d en

hanc

ed th

e qu

ality

and

app

ropr

iate

ness

of

rese

arch

. Im

pact

s w

ere

repo

rted

for a

ll st

ages

of r

esea

rch,

incl

udin

g th

e de

velo

pmen

t of u

ser-

focu

sed

rese

arch

obj

ectiv

es, d

evel

opm

ent o

f use

r-re

leva

nt

rese

arch

que

stio

ns, d

evel

opm

ent o

f use

r-fr

iend

ly in

form

atio

n, q

uest

ionn

aire

s an

d in

terv

iew

sch

edul

es, m

ore

appr

opri

ate

recr

uitm

ent s

trat

egie

s fo

r stu

dies

, co

nsum

er-f

ocus

ed in

terp

reta

tion

of d

ata

and

enha

nced

impl

emen

tatio

n an

d di

ssem

inat

ion

of s

tudy

resu

lts.

Col

eman

et

al. (

2006

), U

SA

To te

sts

inte

rven

tion,

des

igne

d to

enc

oura

ge o

lder

pat

ient

s an

d th

eir c

areg

iver

s to

ass

ert a

m

ore

activ

e ro

le in

thei

r car

e tr

ansi

tions

, can

redu

ce ra

tes

of

preh

ospi

taliz

atio

n

Rand

omiz

ed c

ontr

olle

d tr

ial.

750

com

mun

ity-

dwel

ling

adul

ts o

f 65

year

s or

old

er.

Inte

rven

tion

patie

nts

had

low

er p

reho

spita

lizat

ion

rate

s at

30

days

and

at 9

0 da

ys

than

con

trol

sub

ject

s an

d ho

spita

l cos

ts w

ere

low

er fo

r int

erve

ntio

n pa

tient

s vs

co

ntro

ls a

t 180

day

s. T

hese

find

ings

sug

gest

that

enc

oura

ging

pat

ient

s an

d th

eir

care

give

rs to

ass

ert a

mor

e ac

tive

role

in th

eir c

are

tran

sitio

ns re

sults

in re

duce

d pr

ehos

pita

lizat

ion

rate

s.

Con

nock

et

al. (

2007

), U

K

To e

xam

ine

the

clin

ical

ef

fect

iven

ess

and

cost

-ef

fect

iven

ess

of s

elf-

test

ing

and

self-

man

agem

ent o

f ora

l an

ticoa

gula

tion

trea

tmen

t co

mpa

red

with

clin

ic-b

ased

m

onito

ring

A s

yste

mat

ic re

view

, N

ot a

ll pa

tient

s ar

e ca

pabl

e of

per

form

ing

self-

mon

itori

ng a

nd s

ome

patie

nts

find

it un

nece

ssar

y be

caus

e of

hig

h-qu

ality

car

e pr

ovid

ed b

y ex

istin

g an

ticoa

gula

tion

clin

ics.

For

sel

ecte

d an

d su

cces

sful

ly tr

aine

d pa

tient

s, s

elf-

mon

itori

ng is

eff

ectiv

e an

d sa

fe fo

r lon

g-te

rm o

ral a

ntic

oagu

latio

n th

erap

y. P

atie

nt s

elf-

mon

itori

ng o

f or

al a

ntic

oagu

latio

n th

erap

y is

mor

e ef

fect

ive

than

poo

r-qu

ality

usu

al c

are

prov

ided

by

fam

ily d

octo

rs.

Dav

is e

t el.

(200

8), U

K

To e

xplo

re p

atie

nts’

w

illin

gnes

s to

1) q

uest

ion

HC

Ws

abou

t the

ir tr

eatm

ent

(2) t

o as

k fa

ctua

l vs.

ch

alle

ngin

g qu

estio

ns a

nd to

ex

plor

e ho

w (3

) pat

ient

de

mog

raph

ic c

hara

cter

istic

s co

uld

affe

ct p

atie

nts’

w

illin

gnes

s to

ask

que

stio

ns

and

(4) t

he im

pact

of d

octo

rs’

inst

ruct

ions

on

patie

nts’

w

illin

gnes

s to

ask

que

stio

ns.

Cro

ss-s

ectio

nal d

esig

n us

ing

a pa

tient

sel

f-re

port

su

rvey

. A

con

veni

ence

sa

mpl

e of

80

patie

nts

who

ha

d un

derg

one

surg

ery.

Patie

nts

wer

e al

so m

ore

will

ing

to a

sk n

urse

s ra

ther

than

doc

tors

cha

lleng

ing

ques

tions

. Sig

nific

ant i

mpr

ovem

ents

in p

atie

nts’

will

ingn

ess

to a

sk c

halle

ngin

g qu

estio

ns to

doc

tors

or n

urse

s w

as a

chie

ved

if th

e pa

tient

was

inst

ruct

ed to

ask

su

ch a

que

stio

n by

the

doct

or. P

atie

nts

who

wer

e m

en, u

nem

ploy

ed o

r not

ed

ucat

ed to

deg

ree

leve

l wer

e m

arke

dly

less

will

ing

to q

uest

ion

doct

ors

and

nurs

es. S

ucce

ss o

f cur

rent

saf

ety

initi

ativ

es w

hich

aim

to e

ncou

rage

pat

ient

s to

ask

qu

estio

ns m

ay b

e lim

ited

to th

ose

ques

tions

that

the

patie

nt d

oes

not p

erce

ive

as

chal

leng

ing

clin

ical

ski

lls a

nd a

bilit

ies.

Clin

icia

ns a

nd p

atie

nts

need

to b

e in

ag

reem

ent o

f wha

t is

cons

ider

ed a

ppro

pria

te q

uest

ions

for t

he p

atie

nt to

ask

, be

caus

e pa

tient

s ne

ed to

feel

they

can

ask

que

stio

ns th

at m

ay b

e pe

rcei

ved

as

chal

leng

ing

with

out c

ausi

ng o

ffen

ce to

thos

e in

volv

ed in

thei

r hea

lthca

re

trea

tmen

t.

3/12

A

uth

or(s

),

(yea

r),

cou

ntr

y

Pu

rpos

e an

d a

im(s

) of

th

e st

ud

y D

esig

n,

met

ho

d(s

),

sam

ple

R

esu

lts

Dav

is e

t al.

(201

1), U

K

To e

valu

ate

patie

nts´

atti

tude

s to

war

ds a

vid

eo a

nd le

afle

t ai

med

at e

ncou

ragi

ng p

atie

nt

invo

lvem

ent i

n sa

fety

-rel

ated

be

havi

ors

Mix

ed m

etho

ds d

esig

n;

Expl

orat

ory

stud

ies

(n=2

). M

edic

al a

nd s

urgi

cal

inpa

tient

s: 8

0 pa

tient

s in

st

udy

1 an

d 80

pat

ient

s in

st

udy

2.

Both

inte

rven

tions

wer

e ef

fect

ive

at e

ncou

ragi

ng p

atie

nts

to fe

el c

omfo

rtab

le in

as

king

doc

tors

or n

urse

s w

heth

er th

ey h

ad w

ashe

d th

eir h

ands

and

not

ifyin

g do

ctor

s ⁄ n

urse

s of

pro

blem

s ⁄ e

rror

s in

thei

r car

e. S

tudy

indi

cate

that

if w

e ar

e se

riou

s ab

out e

ngag

ing

patie

nts

in th

e sa

fety

of t

heir

car

e, it

is li

kely

that

gre

ater

ef

fort

s w

ill b

e re

quir

ed th

an s

impl

y de

velo

ping

pat

ient

vid

eos

or le

afle

ts.

Dav

is e

t al.

(201

2), U

K

To in

vest

igat

e pa

tient

s’

will

ingn

ess

to b

e in

volv

ed a

nd

HC

P’ w

illin

gnes

s to

sup

port

pa

tient

invo

lvem

ent i

n pr

e-tr

ansf

usio

n ch

ecki

ng

beha

vior

s.

A c

ross

-sec

tiona

l des

ign.

Su

rvey

s fo

r pat

ient

s

(n=1

10) a

nd h

ealth

care

pr

ofes

sion

als

(n=1

23)

Patie

nts

appe

ared

will

ing

to p

artic

ipat

e in

saf

ety

rele

vant

tran

sfus

ion

beha

vior

s.

Ove

rall

heal

thca

re p

rofe

ssio

nals

indi

cate

d th

at th

ey w

ere

in s

uppo

rt o

f pat

ient

in

volv

emen

t. Bo

th c

ohor

ts e

xpre

ssed

the

mos

t fav

orab

le a

ttitu

des

tow

ards

pa

tient

s no

tifyi

ng s

taff

abo

ut p

robl

ems

to d

o w

ith th

eir h

ospi

tal i

dent

ifica

tion

wri

stba

nd. P

atie

nts

chec

king

the

bloo

d ba

g th

emse

lves

, or a

skin

g st

aff t

o la

bel

bloo

d tu

bes,

wer

e th

e be

havi

ors

that

ove

rall

wer

e de

emed

leas

t acc

epta

ble

to

part

icip

ate

in.

Dav

is e

t al.

(201

5a),

UK

To

exa

min

e pr

edic

tors

of

patie

nts’

inte

ntio

ns to

eng

age

in re

port

ing

an e

rror

to a

na

tiona

l rep

ortin

g sy

stem

and

br

ingi

ng m

edic

ines

into

ho

spita

l.

Cro

ss-s

ectio

nal s

urve

y st

udy.

80

med

ical

and

su

rgic

al h

ospi

tal

inpa

tient

s.

Find

ings

reve

aled

furt

her t

hat a

cros

s bo

th b

ehav

iors

, per

ceiv

ed b

ehav

iora

l con

trol

w

as th

e m

ost i

mpo

rtan

t pre

dict

or o

f pat

ient

s’ in

tent

ions

. In

addi

tion,

in re

latio

n to

re

port

ing

an e

rror

to a

n N

RS,

pat

ient

s’ n

orm

ativ

e be

liefs

abo

ut th

e be

havi

or

play

ed a

sim

ilarl

y sa

lient

con

trib

utio

n.

De

Bru´

n et

al

. (20

17),

UK

To e

xplo

re p

atie

nt

pers

pect

ives

on

prov

idin

g fe

edba

ck o

n sa

fety

ex

peri

ence

s.

Sem

i-str

uctu

red

inte

rvie

ws

with

pat

ient

s (n

=28)

Part

icip

ants

repo

rted

that

pat

ient

saf

ety

was

a h

igh

prio

rity

for p

atie

nts,

but

saf

ety

was

not

a p

rior

ity fo

r pat

ient

s to

thin

k ab

out.

They

als

o as

sum

ed th

at th

eir s

afet

y w

as g

uara

ntee

d du

ring

thei

r sta

y in

hos

pita

l and

thei

r tra

nsfe

r hom

e, w

ith tr

ust

plac

ed in

hea

lth-c

are

prof

essi

onal

s w

ithin

thes

e cl

inic

al s

ettin

gs. T

o pr

ovid

e fe

edba

ck o

n th

eir e

xper

ienc

es o

f saf

ety,

par

ticip

ants

not

ed th

at it

was

nec

essa

ry

for t

he p

roce

ss o

f doi

ng s

o to

be

rela

tivel

y ea

sy a

nd s

truc

ture

d in

a w

ay to

mak

e it

sim

ple

and

stra

ight

forw

ard

to e

ngag

e w

ith. F

or s

ome

patie

nts,

a fe

ar o

f rep

risa

ls

from

sta

ff w

as a

lso

a ba

rrie

r to

prov

idin

g fe

edba

ck.

Dra

ch-

Zaha

vy &

Sh

ilman

(2

015)

, Isr

ael

To d

escr

ibe

the

qual

ity a

nd

scop

e of

pat

ient

s’ p

artic

ipat

ion

in th

e ha

ndov

er p

roce

ss, i

n re

latio

n to

thei

r per

sona

l at

trib

utes

and

the

hand

over

en

coun

ter’

s ch

arac

teri

stic

s.

A q

uant

itativ

e an

d qu

alita

tive

cros

s-se

ctio

nal

desi

gn. S

truc

ture

ob

serv

atio

ns o

f 100

ha

ndov

ers

in fi

ve s

urgi

cal

war

ds.

Patie

nts

view

ed h

ando

ver a

s an

opp

ortu

nity

to g

et in

form

atio

n of

inte

nded

car

e pl

ans

and

sche

dule

s an

d to

und

erst

and

the

prof

essi

onal

nur

sing

jarg

on. T

he

nurs

es fo

und

them

bot

hers

ome,

bec

ause

they

thou

ght t

hat t

he in

form

atio

n re

ques

ted

was

uni

mpo

rtan

t or t

hat h

ando

vers

wer

e no

t the

pro

per t

ime

for s

uch

ques

tioni

ng. T

heir

pur

pose

was

pri

mar

ily in

form

atio

n ex

chan

ge a

mon

g nu

rses

, no

t pat

ient

s. N

urse

s te

nded

to ig

nore

pat

ient

s an

d ta

lk to

eac

h ot

her a

s if

the

patie

nt d

oes

not e

xist

ed. A

lso

nurs

es fr

eque

ntly

reje

cted

pat

ient

s pl

eas

by ‘t

alki

ng

over

thei

r hea

ds,’

usin

g pr

ofes

sion

al ja

rgon

, int

erru

ptin

g th

e pa

tient

’s s

peec

h,

givi

ng te

rse

answ

ers

or te

lling

the

patie

nt to

ask

for i

nfor

mat

ion

from

oth

er a

gent

s or

on

othe

r occ

asio

ns.

4/12

A

uth

or(s

),

(yea

r),

cou

ntr

y

Pu

rpos

e an

d a

im(s

) of

th

e st

ud

y D

esig

n,

met

ho

d(s

),

sam

ple

R

esu

lts

Entw

istle

et

al. (

2010

), U

K

To e

xplo

re p

atie

nts’

and

fa

mily

mem

bers

’ exp

erie

nces

of

and

vie

ws

abou

t spe

akin

g up

abo

ut s

afet

y co

ncer

ns a

t the

po

int o

f car

e

Qua

litat

ive

stud

y us

ing

71 in

divi

dual

inte

rvie

ws

and

12 fo

cus

grou

p di

scus

sion

s.

Patie

nts

ofte

n w

orri

ed th

at s

peak

ing

up m

ight

resu

lt in

sta

ff la

belli

ng th

em a

s di

fficu

lt, a

nd b

eing

less

will

ing

to c

are

for t

hem

in fu

ture

. Spe

akin

g up

is e

asie

r w

hen

heal

thca

re s

taff

giv

e th

e im

pres

sion

of c

arin

g, h

avin

g tim

e an

d w

elco

min

g an

d su

ppor

ting

patie

nts

as le

gitim

ate

cont

ribu

tors

to th

eir c

are.

Par

ticip

ants

als

o de

scri

bed

tryi

ng to

ass

ess

the

rela

tive

impo

rtan

ce o

f the

ir c

once

rn in

the

cont

ext o

f ot

her p

atie

nts’

nee

ds a

nd s

taff

wor

kloa

ds a

nd p

rior

ities

. Et

cheg

aray

et

al.

(201

6),

USA

To 1

) det

erm

ine

whe

ther

pa

tient

s/ fa

mily

mem

bers

in

terv

iew

ed c

ould

iden

tify

at

leas

t one

con

trib

utin

g fa

ctor

fo

r the

eve

nt th

ey e

xper

ienc

ed,

2) u

nder

stan

d th

e w

ay

patie

nts/

fam

ily m

embe

rs

beca

me

awar

e of

AD

Es, t

he

type

s of

con

trib

utin

g fa

ctor

s pa

tient

s/ fa

mily

mem

bers

id

entif

ied

for

diff

eren

t typ

es o

f AD

Es, a

nd

reco

mm

enda

tions

pro

vide

d by

pa

tient

s/fa

mily

mem

bers

to

addr

ess

the

cont

ribu

ting

fact

ors

Sem

istr

uctu

red

inte

rvie

ws

to 7

2 pa

tient

s an

d fa

mily

mem

bers

who

ea

ch d

escr

ibed

a u

niqu

e ad

vers

e ev

ent.

Each

par

ticip

ant i

dent

ified

at l

east

one

con

trib

utin

g fa

ctor

and

on

aver

age

iden

tifie

d 3.

67 c

ontr

ibut

ing

fact

ors

for t

heir

eve

nt. T

he m

ost f

requ

ently

men

tione

d co

ntri

butin

g fa

ctor

s w

ere

HC

Ws

qual

ifica

tions

/kno

wle

dge

(79%

), sa

fety

po

licie

s/pr

oced

ures

(74%

), an

d co

mm

unic

atio

n (6

4%).

Pa

tient

s an

d fa

mily

mem

bers

are

abl

e to

pro

vide

sub

stan

tive

reco

mm

enda

tions

fo

r diff

eren

t con

trib

utin

g fa

ctor

s e.

g. b

ette

r han

dwas

hing

, ste

riliz

atio

n, a

nd

hand

offs

for a

ddre

ssin

g th

e co

ntri

butin

g fa

ctor

of s

afet

y po

licie

s an

d pr

oced

ures

. G

iven

that

thes

e co

ntri

butin

g fa

ctor

s m

ight

not

be

know

n to

hea

lth c

are

orga

niza

tions

bec

ause

mos

t par

ticip

ants

sta

ted

that

they

wer

e no

t inv

olve

d in

the

anal

ysis

pro

cess

, opp

ortu

nitie

s fo

r org

aniz

atio

nal l

earn

ing

from

pat

ient

s ar

e po

tent

ially

bei

ng m

isse

d. H

ealth

car

e or

gani

zatio

ns s

houl

d in

terv

iew

pa

tient

s/fa

mily

abo

ut th

e ev

ent t

hat h

arm

ed th

em to

hel

p en

sure

a fu

ll un

ders

tand

ing

of th

e ca

uses

of t

he e

vent

.

Euro

baro

-m

eter

(201

2),

Euro

pean

co

mm

issi

on

To e

xplo

re p

atie

nts’

and

he

alth

care

pra

ctiti

oner

s’ id

eas

and

attit

udes

, exp

ecta

tions

and

w

ishe

s on

pat

ient

invo

lvem

ent

in th

e ca

re p

roce

ss.

15 in

-dep

th in

terv

iew

s to

pa

tient

s (n

=10)

and

hea

lth

care

pra

ctiti

oner

s (n

=5)

wer

e ca

rrie

d ou

t in

each

of

15

EU M

embe

r Sta

tes.

The

term

“Pa

tient

invo

lvem

ent”

was

not

cle

arly

und

erst

ood

by e

ither

pat

ient

s or

pr

actit

ione

rs a

nd o

ften

mea

nt d

iffer

ent t

hing

s to

diff

eren

t peo

ple.

Man

y pa

tient

s de

scri

bed

a “t

radi

tiona

l doc

tor-

patie

nt re

latio

nshi

p”, w

here

the

doct

or w

as s

een

as

beyo

nd q

uest

ioni

ng a

nd p

atie

nts

felt

unco

mfo

rtab

le g

ivin

g fe

edba

ck. C

hron

ical

ly

ill p

atie

nts

tend

ed to

hav

e m

ore

expe

rien

ce in

sel

f-m

onito

ring

and

oth

er a

spec

ts

and

ofte

n ha

d a

mor

e ta

ngib

le u

nder

stan

ding

of p

atie

nt in

volv

emen

t. Yo

unge

r pa

tient

s an

d th

ose

with

a b

ette

r edu

catio

n ha

d hi

gher

exp

ecta

tions

of t

heir

ow

n in

volv

emen

t. Th

e fin

ding

s fr

om th

is q

ualit

ativ

e st

udy

indi

cate

that

pat

ient

in

volv

emen

t, in

the

sens

e of

hav

ing

patie

nts

at th

e he

art o

f the

hea

lthca

re p

roce

ss,

seem

s po

orly

und

erst

ood

by m

any

prof

essi

onal

s an

d pa

tient

s ac

ross

the

EU.

Flin

k et

al.

(201

2a),

Swed

en

To im

prov

e th

e kn

owle

dge

and

unde

rsta

ndin

g of

pat

ient

s’

pers

pect

ives

abo

ut th

eir

part

icip

atio

n in

han

dove

r.

23 S

wed

ish

patie

nts

with

ch

roni

c di

seas

es w

ere

indi

vidu

ally

inte

rvie

wed

.

The

anal

ysis

resu

lted

in tw

o m

ain

them

es: ‘

Expe

rien

ce o

f par

ticip

atio

n’ a

nd

‘Ena

bler

s fo

r par

ticip

atio

n’ in

han

dove

r com

mun

icat

ion.

Ena

bler

s fo

r par

ticip

atio

n in

clud

ed p

ositi

ve e

ncou

nter

s w

ith p

rovi

ders

, pat

ient

em

pow

erm

ent a

nd b

elie

fs

abou

t org

aniz

atio

nal f

acto

rs. P

atie

nts’

trus

t in

thei

r pro

vide

rs, a

nd p

rovi

ders

’ at

titud

es w

ere

impo

rtan

t fac

tors

in p

atie

nts’

will

ingn

ess

to c

omm

unic

ate.

Pat

ient

s pa

rtic

ipat

e ac

tivel

y in

han

dove

rs w

hen

they

feel

a n

eed

for i

nvol

vem

ent t

o en

sure

co

ntin

uity

of c

are,

and

are

less

act

ive

whe

n th

ey p

erce

ive

that

thei

r con

trib

utio

n is

un

nece

ssar

y or

not

val

ued.

5/12

A

uth

or(s

),

(yea

r),

cou

ntr

y

Pu

rpos

e an

d a

im(s

) of

th

e st

ud

y D

esig

n,

met

ho

d(s

),

sam

ple

R

esu

lts

Flin

k et

al.

(201

2b),

Swed

en

To e

xplo

re th

e pa

tient

s’

expe

rien

ces

and

pers

pect

ives

re

late

d to

the

hand

over

s be

twee

n th

eir p

rim

ary

care

pr

ovid

ers

and

the

inpa

tient

ho

spita

l.

A q

ualit

ativ

e se

cond

ary

anal

ysis

was

per

form

ed,

base

d on

indi

vidu

al a

nd

focu

s gr

oup

patie

nt

inte

rvie

ws

with

90

patie

nts

in fi

ve E

urop

ean

coun

trie

s

Thre

e th

emes

wer

e de

velo

ped:

(1) p

atie

nt p

ositi

onin

g in

the

hand

over

pro

cess

; (2)

pr

ereq

uisi

tes

for p

atie

nt p

artic

ipat

ion;

and

(3) p

atie

nt p

refe

renc

es fo

r the

ha

ndov

er p

roce

ss. P

atie

nts’

par

ticip

atio

n ra

nged

from

bei

ng th

e ke

y ac

tor,

to

shar

ing

the

resp

onsi

bilit

y w

ith h

ealth

care

pro

fess

iona

l(s),

to b

eing

pas

sive

pa

rtic

ipan

ts. P

atie

nts’

par

ticip

atio

n is

rela

ted

to th

e he

alth

care

sys

tem

, the

act

ivity

of

hea

lthca

re p

rofe

ssio

nals

’ and

pat

ient

s’ c

apac

ity fo

r par

ticip

atio

n.

Gui

jarr

o et

al

. (20

10),

Spai

n

To a

naly

ze a

nd c

ompa

re

stud

ies

abou

t pat

ient

’s

perc

eptio

n an

d op

inio

n ab

out

care

saf

ety

in h

ospi

tals

A s

yste

mat

ic re

view

Pa

tient

repo

rtin

g is

a re

liabl

e w

ay to

iden

tify

adve

rse

even

ts a

nd p

rom

otes

pa

tient

-cen

tred

car

e. H

owev

er, a

com

bina

tion

of d

iver

se p

ersp

ectiv

es, s

uch

as

patie

nts’

, pro

fess

iona

ls’ a

nd a

dmin

istr

ator

s’ v

iew

s, a

re re

quir

ed to

add

ress

the

com

plex

ity o

f hea

lthca

re s

afet

y an

d he

nce

to p

ropo

se e

ffic

ient

inte

rven

tions

. Pa

tient

s fe

el s

afe

in h

ospi

tals

, alth

ough

they

sho

wed

diff

eren

t con

cept

of r

isk

from

th

e ex

pert

s. M

ajor

ity o

f pat

ient

s’ d

esir

e fu

ll di

sclo

sure

of a

dver

se e

vent

s an

d an

ex

plan

atio

n or

apo

logy

from

the

phys

icia

n.

Hal

l et a

l. (2

010)

, UK

To

iden

tify,

app

rais

e an

d su

mm

ariz

e ev

alua

tions

of

stra

tegi

es o

r int

erve

ntio

ns

whi

ch h

ave

been

use

d w

ith th

e ex

plic

it in

tent

ion

of p

rom

otin

g pa

tient

s’ in

volv

emen

t in

thei

r ca

re w

ith a

vie

w to

enh

anci

ng

thei

r ow

n, o

r oth

ers’

saf

ety

in a

he

alth

care

con

text

.

A s

yste

mat

ic re

view

, 18

artic

les.

14

indi

vidu

al e

xper

imen

tal a

nd q

uasi

-exp

erim

enta

l stu

dies

plu

s one

sys

tem

atic

re

view

. Thr

ee c

ateg

orie

s; in

form

ing

the

man

agem

ent p

lan,

mon

itori

ng a

nd

ensu

ring

saf

e de

liver

y of

trea

tmen

t and

mak

ing

syst

ems

safe

r. It

was

not

pos

sibl

e to

dra

w a

ny c

lear

con

clus

ions

as

to th

e ef

fect

iven

ess

of th

e in

terv

entio

ns (w

ith th

e ex

cept

ion

of o

ne s

peci

fic a

spec

t of s

elf-

med

icat

ion,

ie, s

elf-

man

agem

ent o

f an

ticoa

gula

tion)

due

to c

once

rns

abou

t the

met

hodo

logi

cal q

ualit

y of

the

stud

ies.

Th

ere

is a

maj

or in

tern

atio

nal m

ovem

ent t

o in

crea

se p

atie

nt in

volv

emen

t with

a

view

to e

nhan

cing

pat

ient

saf

ety.

How

ever

, the

re is

sca

rce

evid

ence

of b

enef

it.

Har

riso

n et

al

. (20

15),

Aus

tral

ia

To s

yste

mat

ical

ly id

entif

y lit

erat

ure,

des

crib

e th

e na

ture

of

AEs

cap

ture

d fr

om th

e pa

tient

per

spec

tive,

iden

tify

limita

tions

in c

urre

nt

know

ledg

e re

gard

ing

patie

nts’

ex

peri

ence

s of

AEs

and

to

asce

rtai

n ch

alle

nges

ass

ocia

ted

with

cap

turi

ng p

atie

nts’

ex

peri

ence

s of

AEs

.

A s

yste

mat

ic re

view

, 15

stud

ies.

Pa

tient

s ar

e ab

le to

reco

gniz

e er

rors

thei

r car

e. T

he e

vide

nce

sugg

ests

that

pat

ient

s de

fined

AEs

bro

adly

, inc

ludi

ng a

rang

e of

qua

lity

and

safe

ty c

once

rns.

In

form

atio

n fr

om p

atie

nts

is c

ritic

al to

iden

tifyi

ng in

cide

nts

and

redu

cing

pat

ient

ha

rm, b

ut th

ey a

re n

ot ro

utin

ely

aske

d to

pro

vide

thes

e da

ta. P

atie

nts’

inco

me,

ed

ucat

ion,

hea

lth b

urde

n an

d m

arita

l sta

tus

influ

ence

like

lihoo

d of

repo

rtin

g.

Patie

nts

repo

rt d

istr

ess

afte

r an

AE,

ofte

n ex

acer

bate

d by

rece

ivin

g in

adeq

uate

in

form

atio

n ab

out t

he c

ause

. Spe

cific

ally

, pat

ient

s ca

n pr

ovid

e va

luab

le

info

rmat

ion

rega

rdin

g pr

oble

ms

with

con

tinui

ty o

f car

e, m

edic

atio

n er

rors

and

co

mm

unic

atio

n be

twee

n st

aff a

nd w

ith p

atie

nts.

Jang

land

&

Gun

ninb

erg

(201

7),

Swed

en

To e

valu

ate

an im

plem

enta

tion

proj

ect o

n pa

tient

par

ticip

atio

n Pa

tient

s (n

= 1

98) i

n fiv

e un

its c

ompl

eted

a

ques

tionn

aire

and

nur

se

man

ager

s (n

= 5

) wer

e in

terv

iew

ed

The

impl

emen

tatio

n pr

ojec

t did

not

impr

ove

patie

nt p

artic

ipat

ion

in th

e un

its, b

ut

nurs

e m

anag

ers

desc

ribe

d a

chan

ging

cul

ture

in w

hich

sta

ff g

rew

to a

ccep

t pa

tient

s’ in

volv

emen

t in

thei

r ow

n ca

re.

6/12

A

uth

or(s

),

(yea

r),

cou

ntr

y

Pu

rpos

e an

d a

im(s

) of

th

e st

ud

y D

esig

n,

met

ho

d(s

),

sam

ple

R

esu

lts

Kab

oli e

t al.

(201

0), U

SA

To a

naly

ze a

nd c

ompa

re fo

ur

diff

eren

t met

hods

of d

etec

ting

med

icat

ion

mis

adve

ntur

es in

or

der t

o de

term

ine

the

optim

al

syst

em fo

r rep

ortin

g cl

inic

ally

ob

serv

ed m

edic

atio

n m

isad

vent

ures

Pros

pect

ive

coho

rt s

tudy

. 12

6 pa

tient

s fr

om 4

8 be

d ge

nera

l int

erna

l med

icin

e in

patie

nt w

ard.

Ver

ified

med

icat

ion

mis

adve

ntur

es w

ere

dete

cted

in 6

3 un

ique

pat

ient

s (4

7%),

and

28 (2

1%) h

ad m

ore

than

one

med

icat

ion

mis

adve

ntur

e. A

dver

se d

rug

even

ts

wer

e de

tect

ed in

30

uniq

ue p

atie

nts.

The

fals

e-ev

ent r

ate

was

rela

tivel

y lo

w fo

r nu

rses

and

phy

sici

ans

(10.

5%) b

ut w

as h

ighe

r for

pat

ient

s (3

9%).

The

volu

ntar

y ho

spita

l rep

ortin

g sy

stem

reco

rded

onl

y 7.

5% o

f the

eve

nts.

Lang

et a

l. (2

016)

, G

erm

any

To b

ette

r ass

ess

patie

nts’

pe

rcep

tions

in p

rim

ary

and

ambu

lato

ry c

are.

A s

yste

mat

ic re

view

, 19

stud

ies.

26

pub

licat

ions

met

all

elig

ibili

ty c

rite

ria.

Con

cern

ing

term

inol

ogy

of a

dver

se

even

ts, t

he te

rm “

med

ical

err

ors”

was

use

d ne

xt to

“m

ista

kes”

, “ad

vers

e ev

ents

”,

“uns

afe

care

”, “

all e

vent

s w

ith re

sulti

ng h

arm

” or

“pr

even

tabl

e pr

oble

ms”

. Pa

tient

s w

ere

able

to id

entif

y ev

ents

that

wer

e tr

aditi

onal

ly re

cogn

ized

by

the

med

ical

com

mun

ity a

s te

chni

cal m

edic

al a

spec

ts (e

.g. e

rror

s in

dia

gnos

is).

Mos

t re

port

ed e

vent

s ho

wev

er c

ould

be

desc

ribe

d as

ser

vice

qua

lity

inci

dent

s.

Espe

cial

ly c

omm

unic

atio

n fa

ctor

s pl

ayed

an

impo

rtan

t rol

e in

the

occu

rren

ce a

nd

cons

eque

nce

of a

dver

se e

vent

s an

d pa

tient

s’ s

atis

fact

ion.

La

wto

n et

al.

(201

6), U

K

To e

valu

ate

the

effic

acy

of th

e Pa

tient

Rep

ortin

g an

d A

ctio

n fo

r a S

afe

Envi

ronm

ent

inte

rven

tion.

A m

ultic

ente

r clu

ster

ra

ndom

ized

con

trol

led

tria

l, 33

hos

pita

l war

ds in

fiv

e ho

spita

ls.

Resu

lts s

ugge

st th

e po

ssib

ility

that

for t

hose

war

ds th

at im

plem

ent t

he

inte

rven

tion

effe

ctiv

ely,

redu

ctio

ns in

pat

ient

har

m a

re fe

asib

le. t

he tr

ial

dem

onst

rate

s th

at p

atie

nt re

port

ing

and

feed

back

is fe

asib

le a

nd a

ccep

tabl

e to

pa

tient

s an

d th

at, w

here

com

plia

nce

with

the

inte

rven

tion

is h

igh,

ther

e is

po

tent

ial f

or it

to b

e ef

fect

ive

in re

duci

ng p

atie

nt h

arm

. Lo

ngtin

et

al. (

2010

), Sw

itzer

land

To re

view

the

unde

rlyi

ng

prin

cipl

es a

nd th

e ef

ficac

y of

pa

tient

par

ticip

atio

n as

wel

l as

the

pote

ntia

l obs

tacl

es to

im

plem

enta

tion

and

to

deve

lop

a co

ncep

tual

fr

amew

ork

for p

atie

nt

part

icip

atio

n.

Com

preh

ensi

ve s

umm

ary

The

conc

ept o

f pat

ient

par

ticip

atio

n re

mai

ns p

oorl

y de

fined

, no

sing

le d

efin

ition

ex

ists

. Pat

ient

par

ticip

atio

n ca

n im

prov

e th

e de

cisi

on-m

akin

g pr

oces

s an

d th

e ca

re

of c

hron

ic il

lnes

s. H

owev

er, m

any

patie

nt a

nd h

ealth

car

e w

orke

r-re

late

d fa

ctor

s ca

n in

fluen

ce it

s ef

ficac

y an

d im

plem

enta

tion.

Sev

eral

pot

entia

l obs

tacl

es c

an b

e fo

rese

en a

t pat

ient

, hea

lth c

are

wor

ker,

and

heal

th c

are

cent

er le

vels

. Giv

en th

e co

ntro

vers

ial n

atur

e of

this

sub

ject

, it w

ill b

e es

sent

ial t

o co

nduc

t rig

orou

s st

udie

s to

ans

wer

the

inhe

rent

que

stio

ning

of t

he c

once

pt.

Lovi

nk e

t al.

(201

5),

Net

herl

ands

To e

xplo

re th

e ex

peri

ence

s of

sa

fety

of a

dult

patie

nts

duri

ng

thei

r hae

mod

ialy

sis

trea

tmen

t.

In-d

epth

indi

vidu

al

inte

rvie

ws

to 1

2 pa

tient

s

Patie

nts

defin

ed s

afet

y in

term

s of

phy

sica

l or e

mot

iona

l saf

ety,

whe

reby

phy

sica

l sa

fety

app

eare

d to

be

a re

quis

ite fo

r em

otio

nal s

afet

y, i.

e. fe

elin

g se

cure

. The

nur

se

had

a pi

vota

l rol

e in

bri

ngin

g ab

out b

oth

form

s of

saf

ety.

Fou

r mai

n ca

tego

ries

w

ere

iden

tifie

d in

the

desc

ript

ions

of h

aem

odia

lysi

s pa

tient

s’ e

xper

ienc

es o

f saf

ety:

(a) i

nsec

urity

; (b)

trus

t in

the

nurs

e; (c

) pre

senc

e of

th

e nu

rse;

and

(d) p

atie

nts’

nee

d to

con

trol

thei

r situ

atio

n.

7/12

A

uth

or(s

),

(yea

r),

cou

ntr

y

Pu

rpos

e an

d a

im(s

) of

th

e st

ud

y D

esig

n,

met

ho

d(s

),

sam

ple

R

esu

lts

Mar

tin e

t al.

(201

3),

Den

mar

k

To in

vest

igat

e ex

istin

g pr

actic

es fo

r pat

ient

in

volv

emen

t in

patie

nt s

afet

y,

and

oppo

rtun

ities

and

bar

rier

s fo

r fur

ther

invo

lvem

ent.

A q

ualit

ativ

e st

udy.

O

bser

vatio

ns fr

om fo

ur

hosp

ital w

ards

and

in

terv

iew

s w

ith 2

5 pa

tient

s w

ith c

ance

r, 11

ho

spita

l doc

tors

, 10

nurs

es, 4

gen

eral

pr

actit

ione

rs a

nd 2

pr

ivat

e pr

actic

ing

gyne

colo

gist

s.

Patie

nt s

afet

y w

as n

ot a

com

mon

topi

c in

the

com

mun

icat

ion

betw

een

patie

nts

and

prof

essi

onal

s in

eve

ryda

y cl

inic

al p

ract

ice.

Pat

ient

safe

ty is

sues

wer

e us

ually

no

t men

tione

d by

the

patie

nt e

ither

. Hea

lth p

rofe

ssio

nals

enc

oura

ged

patie

nt

invo

lvem

ent i

n pa

tient

saf

ety,

but

did

not

do

so s

yste

mat

ical

ly. T

he h

ealth

pr

ofes

sion

als

supp

orte

d th

e id

ea o

f pat

ient

invo

lvem

ent i

n pa

tient

saf

ety

as a

su

pple

men

t to

clin

ical

act

iviti

es th

at s

uppo

rt tr

eatm

ent p

rogr

ess,

how

ever

, the

re

was

a g

ener

al u

ncer

tain

ty o

f how

to in

volv

e pa

tient

s in

pat

ient

saf

ety

beyo

nd

com

plia

nce

and

of w

hat t

he c

onse

quen

ces

of s

uch

invo

lvem

ent w

ould

be.

Mos

t pa

tient

s w

elco

med

ope

nnes

s ab

out s

afet

y, a

nd s

uppo

rted

the

idea

of p

atie

nt

invo

lvem

ent i

n pa

tient

saf

ety.

M

cTie

r et a

l. (2

013)

, A

ustr

alia

To e

xplo

re p

atie

nt

part

icip

atio

n in

the

cont

ext o

f m

edic

atio

n m

anag

emen

t du

ring

a h

ospi

tal a

dmis

sion

fo

r a c

ardi

ac s

urgi

cal

inte

rven

tion

of p

atie

nts

with

ca

rdio

vasc

ular

dis

ease

.

A m

ixed

met

hod

appr

oach

was

use

d in

a

sing

le in

stitu

tion,

cas

e st

udy

desi

gn. P

atie

nt

inte

rvie

ws

(n =

98)

, ob

serv

atio

ns (n

= 4

8) a

nd

focu

s gr

oup

inte

rvie

ws

(n

= 2)

.

Dat

a re

veal

ed a

lack

of e

ngag

emen

t by

nurs

es to

invo

lve

patie

nts

in m

edic

atio

n m

anag

emen

t. N

urse

s ge

nera

lly to

ok a

pro

cedu

ral,

task

-ori

enta

ted

appr

oach

to th

e ad

min

istr

atio

n of

med

icat

ions

mis

sing

opp

ortu

nitie

s to

edu

cate

and

pro

mot

e pa

tient

s’ p

artic

ipat

ion.

It w

as c

lear

that

nur

ses

did

not n

orm

ally

con

side

r pat

ient

pa

rtic

ipat

ion

in m

edic

atio

n m

anag

emen

t as

inte

gral

to th

eir d

aily

goa

ls o

f car

e. T

o in

crea

se th

e op

port

unity

for p

atie

nts

to p

artic

ipat

e in

med

icat

ion

man

agem

ent,

a fu

ndam

enta

l shi

ft in

the

way

nur

ses

curr

ently

pro

vide

car

e is

requ

ired

.

Mitc

hell

et

al. (

2015

), A

ustr

alia

To s

eek

the

wis

dom

and

re

flect

ions

of l

eadi

ng

inte

rnat

iona

l pat

ient

saf

ety

expe

rts

on th

e op

port

uniti

es

and

chal

leng

es n

ot m

et b

y in

cide

nt re

port

ing

sinc

e th

e re

leas

e of

the

IOM

repo

rt

Sem

istr

uctu

red

inte

rvie

ws

with

11

lead

ing

inte

rnat

iona

l au

thor

ities

on

patie

nt

safe

ty.

A n

umbe

r of p

artic

ipan

ts a

rtic

ulat

ed d

isap

poin

tmen

t abo

ut th

e la

ck o

f mea

ning

ful

prog

ress

sin

ce th

at ti

me

in d

eliv

erin

g sa

fer p

atie

nt c

are.

Fiv

e ke

y ch

alle

nges

em

erge

d to

exp

lain

why

inci

dent

repo

rtin

g ha

s no

t rea

ched

its

pote

ntia

l: po

or

proc

essi

ng o

f inc

iden

t rep

orts

(tri

agin

g, a

naly

sis,

reco

mm

enda

tions

), in

adeq

uate

en

gage

men

t of d

octo

rs, i

nsuf

ficie

nt s

ubse

quen

t vis

ible

act

ion,

inad

equa

te fu

ndin

g an

d in

stitu

tiona

l sup

port

of i

ncid

ent r

epor

ting

syst

ems

and

inad

equa

te u

sage

of

evol

ving

hea

lth in

form

atio

n te

chno

logy

. O

cloo

&

Mat

thew

s (2

016)

, UK

To e

xpla

in w

hy w

e th

ink

chan

ging

the

bala

nce

of

pow

er, p

rom

otin

g em

pow

erm

ent,

dive

rsity

and

eq

ualit

y, a

nd s

tren

gthe

ning

ev

alua

tion

of o

utco

mes

and

im

pact

are

the

negl

ecte

d as

pect

s of

invo

lvem

ent.

A s

elec

tive

narr

ativ

e lit

erat

ure

Patie

nts

and

the

wid

er p

ublic

can

be

invo

lved

at m

ost s

tage

s of

hea

lthca

re, a

nd

this

can

hav

e a

num

ber o

f ben

efits

. Unc

erta

inty

per

sist

s ab

out w

hy a

nd h

ow to

do

invo

lvem

ent w

ell a

nd e

valu

ate

its im

pact

, how

to in

volv

e an

d su

ppor

t a d

iver

sity

of

indi

vidu

als,

and

in w

ays

that

allo

w th

em to

wor

k in

par

tner

ship

to g

enui

nely

in

fluen

ce d

ecis

ion-

mak

ing.

Eva

luat

ing

thes

e ap

proa

ches

, to

unde

rsta

nd th

e im

pact

and

eff

ectiv

enes

s of

cho

sen

PPI m

etho

ds, a

s w

ell a

s ho

w in

clus

ive

they

are

, is

impo

rtan

t.

Pana

giot

i et

al. (

2015

), U

K

To e

xam

ine

the

rela

tions

hip

betw

een

mul

timor

bidi

ty a

nd

patie

nt s

afet

y in

cide

nts

in

prim

ary

care

.

A s

yste

mat

ic re

view

and

m

eta-

anal

ysis

, 75

stud

ies.

Met

a-an

alys

is d

emon

stra

ted

that

phy

sica

l-men

tal m

ultim

orbi

dity

was

ass

ocia

ted

with

an

incr

ease

d ri

sk fo

r ‘ac

tive

patie

nt s

afet

y in

cide

nts’

(OR

= 2.

39, 9

5% C

I = 1

.40

to 3

.38)

and

‘pre

curs

ors

of sa

fety

inci

dent

s’ (O

R =

1.69

, 95%

CI =

1.3

6 to

2.0

3).

Phys

ical

mul

timor

bidi

ty w

as a

ssoc

iate

d w

ith a

n in

crea

sed

risk

for a

ctiv

e sa

fety

in

cide

nts

(OR

= 1.

63, 9

5% C

I = 1

.45

to 1

.80)

. Ind

ivid

ually

-tailo

red

care

mod

els

whi

ch p

lace

em

phas

is o

n en

gagi

ng p

atie

nts

with

mul

timor

bidi

ty in

thei

r car

e m

ay

be a

frui

tful a

ppro

ach

for r

educ

ing

safe

ty fa

ilure

s.

8/12

A

uth

or(s

),

(yea

r),

cou

ntr

y

Pu

rpos

e an

d a

im(s

) of

th

e st

ud

y D

esig

n,

met

ho

d(s

),

sam

ple

R

esu

lts

Peat

et a

l. (2

010)

, USA

, U

K

To re

view

the

liter

atur

e on

the

invo

lvem

ent o

f pat

ient

s in

ef

fort

s to

pro

mot

e th

eir o

wn

or

othe

rs ‘s

afet

y w

hile

usi

ng

heal

th c

are

serv

ices

.

Scop

ing

revi

ew, 7

45

publ

icat

ions

. A

tota

l of 4

37 p

ublic

atio

ns d

escr

ibed

one

or m

ore

inte

rven

tions

to p

rom

ote

patie

nt

cont

ribu

tions

to p

atie

nt s

afet

y. B

ased

on

liter

atur

e, a

fram

ewor

k fo

r dev

elop

ed;

info

rmin

g th

e m

anag

emen

t pla

n, m

onito

ring

and

ens

urin

g sa

fe d

eliv

ery

of

trea

tmen

t, an

d in

form

ing

syst

ems

impr

ovem

ent.

Evid

ence

for t

he e

ffec

tiven

ess

of

reco

mm

ende

d sa

fety

-rel

ated

beh

avio

rs is

lack

ing,

gen

eral

ly, p

atie

nts

have

not

be

en in

volv

ed in

the

deve

lopm

ent o

f int

erve

ntio

ns a

nd w

e kn

ow v

ery

little

abo

ut

patie

nts’

will

ingn

ess

and

abili

ty to

ado

pt re

com

men

ded

patie

nt s

afet

y pr

omot

ing

beha

vior

s.

Rain

ey e

t al.

(201

3), U

K

To e

xam

ine

the

expe

rien

ces

and

view

s of

pat

ient

s an

d th

eir

rela

tives

to d

eter

min

e th

e po

tent

ial f

or in

volv

emen

t in

prom

otin

g th

eir o

wn

safe

ty.

Ethn

ogra

phic

stu

dy. 1

3 pa

tient

s an

d 7

rela

tives

fr

om tw

o m

edic

al s

ettin

gs

wer

e in

terv

iew

ed.

Man

y pa

tient

s w

ere

unab

le to

par

ticip

ate

activ

ely

in th

e m

anag

emen

t of t

heir

ac

ute

illne

ss d

ue to

lim

ited

abili

ty to

reco

gniz

e th

e ch

ange

in th

eir c

linic

al

cond

ition

. Hea

lth-c

are

staf

f rou

tinel

y pe

rfor

med

all

mon

itori

ng ta

sks,

for e

xam

ple,

st

aff m

easu

red

bloo

d su

gar l

evel

s fo

r dia

betic

pat

ient

s ev

en th

ough

suc

h pa

tient

s us

ually

mea

sure

d th

is th

emse

lves

at h

ome.

Man

y pa

tient

s re

port

ed th

at th

ey

trus

ted

the

heal

th-c

are

staf

f who

car

ed fo

r the

m. P

atie

nts’

and

rela

tives

’ ex

peri

ence

s su

gges

ts th

at in

terv

entio

n by

hea

lth-c

are

staf

f is

need

ed to

hel

p ov

erco

me

barr

iers

to in

volv

emen

t and

that

sta

ff s

houl

d ac

tivel

y en

cour

age

patie

nts

and

rela

tives

to s

peak

up

abou

t the

ir c

once

rns.

Ra

ther

t et a

l. (2

011)

, USA

To

exp

lore

the

resu

lts o

f a

qual

itativ

e st

udy

in w

hich

pa

tient

s re

port

ed th

eir i

deas

ab

out w

hat t

hey

belie

ve th

eir

role

s sh

ould

be.

Surv

ey s

tudy

to 1

040

patie

nts

with

an

over

nigh

t sta

y.

Patie

nts

mos

t fre

quen

tly s

aid

that

the

patie

nt ro

le is

to fo

llow

inst

ruct

ions

, lis

ten

to th

eir c

are

prov

ider

s an

d ex

pect

com

pete

nt c

are.

If p

atie

nts

do in

deed

bel

ieve

th

at th

ey s

houl

d lis

ten

and

follo

w in

stru

ctio

ns, s

trat

egie

s th

at re

quir

e cl

inic

ians

to

prov

ide

patie

nt e

ngag

emen

t ins

truc

tions

mig

ht b

e ef

fect

ive.

Our

resu

lts s

ugge

st

that

eng

agin

g pa

tient

s in

saf

ety

effo

rts

may

be

com

plex

, req

uiri

ng a

var

iety

of

stra

tegi

es. M

anag

ers

mus

t pro

vide

env

iron

men

ts c

ondu

cive

to s

taff

and

pat

ient

in

tera

ctio

ns to

sup

port

pat

ient

s in

this

eff

ort.

Rhod

es e

t al.

(201

5), U

K

To e

xplo

re p

atie

nts’

un

ders

tand

ings

of s

afet

y in

pr

imar

y ca

re.

Inte

rvie

ws

to 3

8 pa

tient

s.

It w

as d

iffic

ult f

or p

eopl

e to

dis

enta

ngle

the

vari

ous

dim

ensi

ons

of s

afet

y fr

om

qual

ity. F

or p

atie

nts,

saf

ety

is n

ot ju

st a

pro

pert

y of

sys

tem

s, b

ut p

erso

nal a

nd

cont

inge

nt a

nd is

real

ized

in th

e in

tera

ctio

n be

twee

n do

ctor

and

pat

ient

. How

ever

, it

is th

e sy

stem

s ap

proa

ch th

at h

as d

omin

ated

saf

ety

thin

king

, and

pat

ient

s’

indi

vidu

alis

tic a

nd re

latio

nal c

once

ptua

lizat

ions

are

poo

rly

acco

mm

odat

ed w

ithin

cu

rren

t ser

vice

org

aniz

atio

n.

Russ

et a

l. (2

014)

, UK

To

ass

ess

patie

nts’

vie

ws

of th

e ch

eckl

ist,

whi

ch h

ave

yet t

o be

co

nsid

ered

and

cou

ld in

form

its

app

ropr

iate

use

, and

in

fluen

ce c

linic

al b

uy-in

.

Surv

ey to

141

sur

gica

l pa

tient

s.

8.7%

of t

he p

atie

nts

(N=1

2) re

port

ed th

at th

ey h

ad e

xper

ienc

ed a

pre

viou

s ad

vers

e ev

ent i

n ho

spita

l. 8

7% o

f pat

ient

s ag

reed

that

they

wou

ld li

ke th

e ch

eckl

ist t

o be

us

ed if

they

wer

e ha

ving

an

oper

atio

n an

d st

rong

ly a

gree

d th

at it

wou

ld im

pact

po

sitiv

ely

on th

eir s

afet

y an

d on

sur

gica

l tea

m p

erfo

rman

ce. P

atie

nts

did

not f

eel

they

had

a s

tron

g ro

le to

pla

y in

saf

ety

impr

ovem

ent m

ore

broa

dly.

We

have

de

mon

stra

ted

stro

ng s

uppo

rt fo

r the

che

cklis

t in

a sa

mpl

e of

sur

gica

l pat

ient

s,

pres

entin

g a

chal

leng

e to

thos

e re

sist

ant t

o its

use

.

9/12

A

uth

or(s

),

(yea

r),

cou

ntr

y

Pu

rpos

e an

d a

im(s

) of

th

e st

ud

y D

esig

n,

met

ho

d(s

),

sam

ple

R

esu

lts

Schw

appa

ch

(201

0),

Switz

erla

nd

To a

sses

s an

d su

mm

ariz

e th

e cu

rren

t evi

denc

e re

late

d to

pa

tient

par

ticip

atio

n in

err

or

prev

entio

n.

A s

yste

mat

ic re

view

, 21

stud

ies.

St

udie

s su

gges

t tha

t, on

a g

ener

aliz

ed le

vel,

patie

nts

and

the

publ

ic a

re re

cept

ive

to a

nd p

rovi

de s

tron

g su

ppor

t for

pat

ient

s’ a

ctiv

e ro

le in

err

or p

reve

ntio

n.

Patie

nts

repo

rt a

hig

her l

ikel

ihoo

d of

inte

rven

ing

agai

nst n

urse

s th

an a

gain

st

phys

icia

ns, i

n pa

rtic

ular

if c

halle

ngin

g in

tera

ctio

ns a

re in

volv

ed. B

ut p

atie

nts’

w

illin

gnes

s to

ask

doc

tors

rais

ed if

it w

as in

stru

cted

to b

y a

doct

or. E

mpi

rica

l re

sear

ch c

onfir

ms

the

fram

ewor

k of

the

theo

ry o

f pla

nned

beh

avio

r and

indi

cate

s th

at s

elf-

effic

acy,

beh

avio

ral c

ontr

ol b

elie

fs, t

he p

reve

ntab

ility

of i

ncid

ents

, and

th

e pe

rcei

ved

effe

ctiv

enes

s of

act

ions

see

m to

be

cent

ral t

o pa

tient

s’ in

tent

ions

to

enga

ge in

thei

r saf

ety

and

subs

eque

nt b

ehav

ior.

Sc

hwap

pach

et

al.

(201

3),

Switz

erla

nd

To in

vest

igat

e ho

w H

CPs

ev

alua

te p

atie

nts’

beh

avio

rs

and

HC

P re

spon

ses

to p

atie

nt

invo

lvem

ent i

n th

e be

havi

or,

rela

tive

to d

iffer

ent a

spec

ts o

f th

e pa

tient

, the

invo

lved

HC

P an

d th

e po

tent

ial e

rror

.

Cro

ss-s

ectio

nal f

ract

iona

l fa

ctor

ial s

urve

y to

114

1 H

CPs

from

12

hosp

itals

in

Switz

erla

nd.

HC

Ps a

ppro

ved

of th

e pa

tient

inte

rven

ing,

eve

n if

they

felt

the

sam

e si

tuat

ion

coul

d ha

ve n

egat

ive

effe

cts

on th

e do

ctor

–pat

ient

rela

tions

hip

and

irre

spec

tive

of

how

the

situ

atio

n w

ould

mak

e th

em fe

el p

erso

nally

. Ove

rall,

HC

Ps e

xpre

ssed

m

ore

favo

rabl

e at

titud

es to

war

ds p

atie

nts

inte

rven

ing

abou

t a m

edic

atio

n er

ror

than

abo

ut h

and

sani

tatio

n.

Schw

appa

ch

& W

ernl

i (2

010a

), Sw

itzer

land

To e

xam

ine

and

empi

rica

lly

test

the

rela

tions

hips

bet

wee

n at

titud

es, n

orm

s, a

nd

beha

vior

al c

ontr

ol a

nd

chem

othe

rapy

pat

ient

s’

inte

ntio

ns to

par

ticip

ate

in

erro

r pre

vent

ion.

A q

uant

itativ

e, c

ross

-se

ctio

nal s

urve

y st

udy

amon

g ch

emot

hera

py

patie

nts

(n=4

79) t

reat

ed a

t th

e on

colo

gy/ h

emat

olog

y de

part

men

t

Beha

vior

al c

ontr

ol, t

hat i

s, tr

ust i

n on

e’s

own

abili

ty, w

as th

e m

ajor

pre

dict

or o

f in

tend

ing

to m

onito

r tre

atm

ent s

afet

y. F

indi

ngs

high

light

the

impo

rtan

t rol

e of

pe

rcep

tions

of o

ther

s’ a

ppro

val i

n pr

edic

ting

inte

ntio

ns to

eng

age

in s

afet

y, th

at is

, su

bjec

tive

norm

s. P

atie

nts

who

per

ceiv

e st

rong

exp

ecta

tions

to re

port

err

ors

and

thus

feel

pot

entia

l to

gain

app

rova

l or s

uffe

r san

ctio

ns h

ave

stro

nger

inte

ntio

ns to

ac

t.

Schw

appa

ch

& W

ernl

i (2

010b

), Sw

itzer

land

To a

sses

s ch

emot

hera

py

patie

nts’

per

cept

ions

of s

afet

y an

d th

eir a

ttitu

des

tow

ards

pa

rtic

ipat

ing

in e

rror

-pr

even

tion

stra

tegi

es

Sem

i str

uctu

red

inte

rvie

ws

to 3

0 ch

emot

hera

py p

atie

nts.

Four

teen

pat

ient

s re

port

ed e

xper

ienc

es w

ith e

rror

s an

d ad

vers

e ev

ents

in

chem

othe

rapy

. Des

pite

thes

e ex

peri

ence

s, p

atie

nts

repo

rted

feel

ing

safe

and

wer

e re

lativ

ely

unw

orri

ed a

bout

err

ors.

A n

umbe

r of p

atie

nts

expl

aine

d th

at, t

o th

em,

part

icip

atio

n in

saf

ety

was

a le

arni

ng p

roce

ss. I

t sta

rts

with

ver

y lim

ited

know

ledg

e an

d fe

elin

gs o

f str

ain

at th

e be

ginn

ing

of th

erap

y an

d pr

ocee

ds, w

ith

addi

tiona

l exp

erie

nces

of c

hem

othe

rapy

adm

inis

trat

ion,

to s

ome

leve

l of ‘

expe

rt

stat

us’.

At t

he fo

llow

-up

inte

rvie

w, s

ever

al p

atie

nts

repo

rted

hav

ing

impl

emen

ted

the

pote

ntia

l saf

ety

beha

vior

s di

scus

sed

at b

asel

ine.

Par

ticip

ants

une

quiv

ocal

ly

agre

ed th

at p

atie

nts

can

mak

e co

ntri

butio

ns to

thei

r saf

ety.

Nei

ther

wor

ry n

or

will

ingn

ess

to e

ngag

e in

saf

ety

seem

ed to

be

affe

cted

by

prio

r err

or e

xper

ienc

es,

exce

pt th

at p

atie

nts

who

repo

rted

err

ors

shar

ed a

bro

ader

und

erst

andi

ng o

f po

tent

ial e

rror

s an

d a

mor

e pr

ecis

e un

ders

tand

ing

of h

ow to

par

ticip

ate

in e

rror

-pr

even

tion

stra

tegi

es.

10/1

2 A

uth

or(s

),

(yea

r),

cou

ntr

y

Pu

rpos

e an

d a

im(s

) of

th

e st

ud

y D

esig

n,

met

ho

d(s

),

sam

ple

R

esu

lts

Schw

appa

ch

& W

ernl

i (2

011)

, Sw

itzer

land

To e

xplo

re c

hem

othe

rapy

pa

tient

s’ in

tent

ions

to e

ngag

e in

med

ical

err

or p

reve

ntio

n an

d to

stu

dy w

hich

err

or

prev

entin

g be

havi

ors

are

acce

ptab

le to

pat

ient

s.

A c

ross

-sec

tiona

l sur

vey

stud

y am

ong

chem

othe

rapy

pat

ient

s (n

=479

) tre

ated

at t

he

onco

logy

/ he

mat

olog

y un

it

11.5

% o

f par

ticip

ants

repo

rted

to h

ave

expe

rien

ced

erro

rs in

thei

r car

e an

d 10

.6%

w

ere

very

con

cern

ed a

bout

the

safe

ty o

f the

ir c

are.

77.

3% o

f pat

ient

s ag

reed

that

pa

tient

s ca

n he

lp to

pre

vent

err

ors.

Pat

ient

s’ h

ealth

con

ditio

n, s

taff

tim

e pr

essu

re

or s

tres

s an

d kn

owle

dge

wer

e pe

rcei

ved

as m

ost r

elev

ant b

arri

ers

to p

erfo

rm

beha

vior

s. S

taff

nee

d to

be

awar

e of

the

impa

ct s

ubje

ctiv

e no

rms

attr

ibut

ed to

th

em h

as o

n pa

tient

s’ b

ehav

ior.

Thus

, cle

ar a

nd s

uppo

rtiv

e co

mm

unic

atio

n of

ex

pect

atio

ns a

nd a

ppro

pria

te re

spon

se to

pat

ient

s’ p

artic

ipat

ion

is o

f hig

h im

port

ance

. The

pro

cess

of e

ngag

ing

in s

afet

y m

ust b

e m

ade

mor

e co

mfo

rtab

le fo

r pa

tient

s.

Seal

e et

al.

(201

5),

Aus

tral

ia

To e

xam

ine

the

rece

ptiv

enes

s of

hos

pita

l pat

ient

s to

war

d a

new

em

pow

erm

ent t

ool a

imed

at

incr

easi

ng a

war

enes

s an

d en

gage

men

t of p

atie

nts

in

prev

entin

g H

CA

I.

A p

rosp

ectiv

e, c

ontr

olle

d in

terv

entio

n st

udy.

A

tota

l of 6

0 pa

tient

s (3

0 in

ea

ch g

roup

).

Part

icip

ants

felt

that

they

wer

e m

ost a

t ris

k of

dev

elop

ing

an in

fect

ion

whe

n st

aff

do n

ot w

ash

thei

r han

ds b

efor

e or

afte

r a p

roce

dure

(95%

) and

whe

n st

aff c

ome

to

wor

k (ie

, to

the

hosp

ital)

with

a fl

u-lik

e ill

ness

(91.

7%),

whe

n th

ey d

o no

t wea

r a

mas

k fo

r a p

roce

dure

(85.

0%),

and

whe

n th

ey a

re n

ot v

acci

nate

d ag

ains

t inf

luen

za

(61.

7%).

Just

ove

r hal

f of t

he p

artic

ipan

ts w

ere

high

ly w

illin

g to

ass

ist w

ith

infe

ctio

n co

ntro

l str

ateg

ies.

Par

ticip

ants

wer

e si

gnifi

cant

ly m

ore

likel

y to

be

will

ing

to a

sk a

doc

tor o

r nur

se a

fact

ual q

uest

ion

then

a c

halle

ngin

g qu

estio

n.

Onl

y 3

part

icip

ants

ask

ed a

n H

CW

(1 p

artic

ipan

t ask

ed a

doc

tor,

2 pa

rtic

ipan

ts

aske

d nu

rses

) whe

ther

they

had

was

hed

thei

r han

ds.

Seve

rins

son

& H

olm

(2

015)

, N

orw

ay

To id

entif

y an

d ev

alua

te th

e ev

iden

ce c

ontr

ibut

ed b

y st

udie

s of

pat

ient

invo

lvem

ent

in th

e pr

ovis

ion

of s

afe

care

.

Syst

emat

ic re

view

; 15

artic

les

Evid

ence

of t

he p

atie

nt’s

role

in p

atie

nt s

afet

y is

sca

re, t

hus

mor

e re

sear

ch is

re

quir

ed. M

ain

findi

ng o

f the

revi

ew w

as th

e im

port

ance

of p

heno

men

a su

ch a

s,

resp

onsi

bilit

y, tr

ust,

pow

erle

ssne

ss, a

nd s

hare

d de

cisi

on-m

akin

g, w

hich

con

stitu

te

the

core

feat

ures

that

incr

ease

pat

ient

s’ in

volv

emen

t in

thei

r ow

n sa

fety

. Su

tton

et a

l. (2

015)

, To

ass

ess

the

evid

ence

for t

he

exte

nt a

nd ty

pe o

f in

volv

emen

t the

pub

lic o

r pa

tient

s ha

ve h

ad in

thei

r saf

ety

Stru

ctur

ed li

tera

ture

re

view

, 27

artic

les

The

liter

atur

e on

pat

ient

invo

lvem

ent i

n pa

tient

saf

ety

refle

cts

a fie

ld th

at is

stil

l la

rgel

y in

its

infa

ncy

and

whe

re e

vide

nce

for e

ffica

cy o

f inv

olve

men

t and

for g

ood

prac

tice

in p

rom

otin

g in

volv

emen

t is

scan

t. It

is im

port

ant t

o en

sure

that

pat

ient

s ha

ve th

e op

port

unity

to c

onsi

der a

nd c

omm

ent o

n po

ssib

le m

easu

res

to im

prov

e th

e sa

fety

that

is b

eing

test

ed. T

his

is s

till q

uite

spo

radi

c. T

his

revi

ew e

mph

asiz

e th

at a

ttent

ion

to o

ptim

izin

g th

e pr

oces

s of

invo

lvem

ent i

n pa

tient

saf

ety

is

unlik

ely

to re

sult

in o

ptim

al in

fluen

ce fo

r pat

ient

s w

ithou

t wid

er o

rgan

izat

iona

l, st

ruct

ural

, and

cul

tura

l cha

nge.

Ti

er e

t al.

(201

6), U

K

To s

umm

ariz

e w

ork

cond

ucte

d on

a s

copi

ng re

view

of

inte

rven

tions

focu

sing

on

patie

nt in

volv

emen

t for

pa

tient

saf

ety;

to d

evel

op

cons

ensu

s-ba

sed

reco

mm

enda

tions

in th

is a

rea

Scop

ing

revi

ew o

f the

lit

erat

ure,

13

artic

les

and

9 re

port

s.

Thir

teen

art

icle

s an

d ni

ne re

port

s w

ere

incl

uded

in th

e st

udy.

The

sco

ping

revi

ew

iden

tifie

d on

ly w

eak

evid

ence

in s

uppo

rt o

f the

eff

ectiv

enes

s of

pat

ient

in

volv

emen

t. Th

e re

view

als

o id

entif

ied

a nu

mbe

r of f

acto

rs th

at in

fluen

ce th

e ab

ility

and

will

ingn

ess

of p

atie

nts

to b

e in

volv

ed in

pat

ient

saf

ety.

Ena

blin

g fa

ctor

s in

clud

e vu

lner

abili

ty to

saf

ety

issu

es, y

oung

er a

ge fe

mal

e se

x an

d hi

gher

ed

ucat

iona

l lev

el. S

peci

fic b

arri

ers

rela

ted

to p

atie

nt c

hara

cter

istic

s ar

e ol

d ag

e,

lack

of e

duca

tion,

non

-Wes

tern

bac

kgro

und

whi

le p

rofe

ssio

nal ’

s tr

aini

ng a

nd

spec

ializ

atio

n po

se b

arri

ers

cent

red

arou

nd th

e he

alth

pro

fess

iona

l. H

ealth

w

orke

rs ’

attit

udes

are

em

phas

ized

as

cruc

ial f

or p

atie

nts

’ will

ingn

ess

to b

e in

volv

ed a

nd to

spe

ak u

p if

they

hav

e sa

fety

con

cern

s.

11/1

2 A

uth

or(s

),

(yea

r),

cou

ntr

y

Pu

rpos

e an

d a

im(s

) of

th

e st

ud

y D

esig

n,

met

ho

d(s

),

sam

ple

R

esu

lts

Tobi

ano

et

al. (

2015

a),

Aus

tral

ia

To in

vest

igat

e pa

tient

s’ a

nd

nurs

es’ p

erce

ptio

ns o

f and

be

havi

ors

tow

ards

pat

ient

pa

rtic

ipat

ion

in n

ursi

ng c

are

in

the

cont

ext o

f hos

pita

l med

ical

w

ards

.

Inte

grat

ive

revi

ew, 8

st

udie

s.

Alth

ough

the

bene

fits

of p

atie

nt p

artic

ipat

ion

are

prom

isin

g, p

atie

nt p

artic

ipat

ion

is n

ot e

asily

ach

ieve

d on

med

ical

war

ds. B

y ov

erco

min

g va

riou

s ba

rrie

rs (p

atie

nt

capa

bilit

ies,

pat

ient

s’ p

refe

renc

es a

re n

ot fi

xed,

inco

ngru

ence

bet

wee

n pa

tient

and

nu

rse

expe

ctat

ions

for p

atie

nt p

artic

ipat

ion,

uns

uppo

rtiv

e an

d ta

sk-o

rien

ted

man

ners

of n

urse

s) p

atie

nts

and

nurs

es c

an p

oten

tially

reap

the

bene

fits

of a

ctiv

e pa

tient

par

ticip

atio

n an

d cr

eate

saf

ety

cultu

res

in h

ospi

tals

. Inv

olvi

ng p

atie

nts

in

asse

ssm

ent a

nd c

are

plan

ning

may

als

o en

hanc

e pa

tient

par

ticip

atio

n.

Tobi

ano

et

al. (

2015

b),

Aus

tral

ia

To e

xplo

re n

urse

s’ v

iew

s of

pa

tient

par

ticip

atio

n in

nu

rsin

g ca

re o

n m

edic

al

war

ds.

Inte

rpre

tive

stud

y. In

-de

pth

sem

i-str

uctu

red

inte

rvie

ws

to n

urse

s (n

=20)

Our

find

ings

reve

aled

nur

ses

perc

eive

d th

emse

lves

as

acce

ptin

g an

d en

ablin

g of

bo

th p

hysi

cal a

nd v

erba

l par

ticip

atio

n. H

owev

er, n

urse

s fe

lt lim

ited

by ru

les,

pe

rcep

tions

of m

aint

aini

ng s

afet

y an

d pa

tient

cha

ract

eris

tics

whe

n at

tem

ptin

g to

en

act p

artic

ipat

ion.

Med

icat

ion

adm

inis

trat

ion

is a

n ar

ea w

here

nur

ses

foun

d pa

tient

invo

lvem

ent t

o be

risk

y. N

urse

par

ticip

ants

in th

e st

udy

high

light

ed th

e im

port

ance

of t

he n

urse

’s ro

le in

faci

litat

ing

patie

nt p

artic

ipat

ion.

V

aism

orad

i et

al.

(201

4),

Nor

way

To s

ynth

esiz

e th

e ex

istin

g re

sear

ch o

n ho

w p

atie

nts

part

icip

ate

in p

atie

nt s

afet

y in

itiat

ives

.

Syst

emat

ic re

view

usi

ng

inte

grat

ive

met

hods

, 17

empi

rica

l res

earc

h pa

pers

.

Nur

ses’

pos

itive

atti

tude

s, e

ncou

rage

men

t, su

ppor

t, kn

owle

dge

and

educ

atio

n ar

e ce

ntra

l to

patie

nt p

artic

ipat

ion

in s

afet

y pr

actic

es. P

atie

nt e

duca

tion

to im

prov

e pa

tient

par

ticip

atio

n re

quir

es: p

rovi

sion

of i

nfor

mat

ion

on a

vaila

ble

part

icip

atio

n m

odal

ities

, im

prov

emen

t of p

atie

nts’

cap

aciti

es fo

r tak

ing

resp

onsi

bilit

y an

d be

havi

or c

hang

es. P

atie

nt p

artic

ipat

ion

need

s a

supp

ortiv

e m

anag

emen

t sys

tem

th

at c

ontin

uous

ly id

entif

ies a

nd a

ddre

sses

any

and

all

syst

em w

eakn

esse

s an

d fa

ilure

s th

at a

rise

, and

is c

omm

itted

to s

uppo

rt in

volv

emen

t cha

lleng

e po

wer

in

equi

ties

and

empo

wer

pat

ient

s.

Van

Gaa

l et

al. (

2011

)a,

Net

herl

ands

To te

st th

e ef

fect

of t

he S

AFE

or

SO

RRY?

pro

gram

me

on th

e in

cide

nce

of th

ree

adve

rse

even

ts (p

ress

ure

ulce

rs,

urin

ary

trac

t inf

ectio

ns a

nd

falls

).

A c

lust

er ra

ndom

ized

tr

ial,

ten

war

ds fr

om

hosp

itals

and

ten

war

ds

from

six

nur

sing

hom

es.

Sim

ulta

neou

s im

plem

enta

tion

of m

ultip

le g

uide

lines

is n

ot o

nly

poss

ible

, but

can

be

eff

ectiv

e as

wel

l. In

bot

h ho

spita

ls a

nd n

ursi

ng h

omes

, pat

ient

s in

the

inte

rven

tion

grou

ps d

evel

oped

few

er a

dver

se e

vent

s co

mpa

red

to p

atie

nts

in th

e us

ual c

are

grou

ps. P

atie

nts

in th

e in

terv

entio

n gr

oups

dev

elop

ed 4

3% a

nd 3

3%

few

er a

dver

se e

vent

s co

mpa

red

to th

e us

ual c

are

grou

ps in

hos

pita

ls a

nd n

ursi

ng

hom

es re

spec

tivel

y.

Wat

t et a

l. (2

009)

, C

anad

a

To in

vest

igat

e ho

w p

atie

nts

(and

thei

r fam

ily m

embe

rs a

nd

othe

r rep

rese

ntat

ives

) mig

ht

appr

opri

atel

y be

invo

lved

in

thei

r hea

lth c

are

to e

ffec

tivel

y pr

omot

e th

eir o

wn

safe

ty, a

nd

to e

xplo

re h

ow th

is m

ay v

ary

by c

onte

xt, p

lace

, or

dem

ogra

phy.

3 ph

ases

; 1) l

itera

ture

re

view

2) i

n-de

pth

indi

vidu

al in

terv

iew

s an

d fo

cus

grou

ps, 3

) pilo

t tes

t an

app

roac

h to

enh

anci

ng

safe

ty w

hich

invo

lved

in

divi

dual

pat

ient

s fe

edin

g ba

ck th

eir

part

icul

ar e

xper

ienc

es

whi

le u

sing

NH

S se

rvic

es

to re

leva

nt c

linic

al

gove

rnan

ce g

roup

s

Thre

e br

oad

rout

es b

y w

hich

pat

ient

s’ a

ctio

ns m

ight

con

trib

ute

to th

eir s

afet

y w

ere

iden

tifie

d; in

form

ing

the

man

agem

ent p

lan,

mon

itori

ng a

nd e

nsur

ing

safe

de

liver

y of

trea

tmen

t and

info

rmin

g sy

stem

s im

prov

emen

ts. P

atie

nts

wer

e w

illin

g to

eng

age

with

the

topi

c of

pat

ient

invo

lvem

ent i

n pa

tient

saf

ety

and

that

they

had

a

broa

d un

ders

tand

ing

of th

e is

sues

invo

lved

. Stu

dy p

artic

ipan

ts e

xpre

ssed

a

desi

re to

be

invo

lved

in p

rom

otin

g an

d en

hanc

ing

thei

r ow

n sa

fety

, but

diff

ered

w

idel

y in

thei

r vie

ws

abou

t whi

ch p

atie

nt s

afet

y ro

les

they

con

side

red

appr

opri

ate

for t

hem

selv

es o

r oth

ers

to a

dopt

, and

the

circ

umst

ance

s in

whi

ch

patie

nts

shou

ld a

ct to

pro

mot

e th

eir o

wn

safe

ty. P

artic

ipan

ts e

mph

asiz

ed th

e im

port

ance

of h

ealth

car

e pr

ofes

sion

als’

atti

tude

s an

d be

havi

or in

faci

litat

ing

thei

r in

volv

emen

t in

safe

ty ro

les.

The

inte

rven

tion

was

larg

ely

eval

uate

d by

pat

ient

s an

d st

aff a

s fe

asib

le, a

ccep

tabl

e an

d us

eful

.

12/1

2 A

uth

or(s

),

(yea

r),

cou

ntr

y

Pu

rpos

e an

d a

im(s

) of

th

e st

ud

y D

esig

n,

met

ho

d(s

),

sam

ple

R

esu

lts

War

d &

A

rmita

ge

(201

2), U

K

To e

xplo

re th

e ty

pes

of p

atie

nt

safe

ty in

cide

nts

iden

tifie

d by

pa

tient

s, th

e se

tting

s in

whi

ch

patie

nts

have

bee

n as

ked

to

repo

rt o

n pa

tient

saf

ety

inci

dent

s, th

e tim

ing

of p

atie

nt

repo

rts

of p

atie

nt s

afet

y in

cide

nts

in re

latio

n to

the

expe

rien

ce o

f the

pat

ient

saf

ety

‘eve

nt’ a

nd h

ow p

atie

nts

have

be

en a

sked

to re

port

upo

n pa

tient

saf

ety

inci

dent

s, a

nd

wha

t has

bee

n do

ne w

ith th

is

info

rmat

ion.

A s

yste

mat

ic re

view

, 13

pape

rs.

13 p

aper

s w

ere

incl

uded

in re

view

. All

pape

rs c

oncl

uded

that

pat

ient

s w

ere

able

to

repo

rt o

n pa

tient

saf

ety

inci

dent

s in

a h

ospi

tal s

ettin

g. W

ith re

gard

to w

hat i

s do

ne w

ith th

e in

form

atio

n fr

om p

atie

nt re

port

s, n

one

of th

e pa

pers

in th

is re

view

m

entio

ned

how

saf

ety

info

rmat

ion

from

pat

ient

s co

uld

be u

sed

as p

art o

f the

w

ider

clin

ical

gov

erna

nce/

qual

ity im

prov

emen

t age

nda.

The

lite

ratu

re s

ugge

sts

that

pat

ient

repo

rtin

g is

in it

s in

fanc

y, w

ith in

clud

ed p

aper

s va

ryin

g co

nsid

erab

ly

in te

rms

of th

eir f

ocus

, des

ign

and

qual

ity w

ith a

ll pa

pers

lack

ing

a th

eore

tical

un

derp

inni

ng.

Wat

erm

an e

t al

. (20

06),

USA

To d

eter

min

e ho

w c

omfo

rtab

le

patie

nts

wer

e in

taki

ng e

rror

-pr

even

tion

actio

ns, h

ow o

ften

they

eng

aged

in th

ese

actio

ns

whi

le h

ospi

taliz

ed, a

nd

whe

ther

err

or p

reve

ntio

n af

fect

ed th

eir h

ospi

taliz

atio

n sa

tisfa

ctio

n.

Tele

phon

e in

terv

iew

s w

ith 2

078

patie

nts

disc

harg

ed fr

om 1

1 M

idw

est h

ospi

tals

.

Nin

ety-

one

perc

ent a

gree

d th

at p

atie

nts

coul

d he

lp p

reve

nt e

rror

s. P

atie

nts

wer

e ve

ry c

omfo

rtab

le a

skin

g a

med

icat

ion’

s pu

rpos

e (9

1%),

gene

ral m

edic

al q

uest

ions

(8

9%),

and

conf

irm

ing

thei

r ide

ntity

(84%

), bu

t wer

e un

com

fort

able

ask

ing

med

ical

pro

vide

rs w

heth

er th

ey h

ad w

ashe

d th

eir h

ands

(46%

ver

y co

mfo

rtab

le).

Whi

le h

ospi

taliz

ed, m

any

aske

d qu

estio

ns a

bout

thei

r car

e (8

5%) a

nd a

m

edic

atio

n’s

purp

ose

(75%

), bu

t few

er c

onfir

med

they

wer

e th

e co

rrec

t pat

ient

(3

8%),

help

ed m

ark

thei

r inc

isio

n si

te (1

7%),

or a

sked

abo

ut h

andw

ashi

ng (5

%).

Wei

ngar

t et

al. (

2011

), U

SA

To u

nder

stan

d th

e ex

tent

to

whi

ch h

ospi

taliz

ed p

atie

nts

part

icip

ate

in th

eir c

are,

and

th

e as

soci

atio

n of

pat

ient

pa

rtic

ipat

ion

with

qua

lity

of

care

and

pat

ient

saf

ety.

Rand

om s

ampl

e te

leph

one

surv

ey (n

=202

5)

to p

atie

nts

and

med

ical

re

cord

revi

ew (n

=998

)

The

impa

ct o

f pat

ient

par

ticip

atio

n on

pat

ient

saf

ety

is c

ompl

ex a

nd

met

hodo

logi

cally

cha

lleng

ing.

Of t

he 2

025

patie

nts

surv

eyed

, 99.

9% o

f pat

ient

s re

port

ed p

ositi

ve re

spon

ses

to a

t lea

st o

ne o

f sev

en m

easu

res

of p

artic

ipat

ion.

H

igh

part

icip

atio

n (u

se o

f .4

activ

ities

) was

str

ongl

y as

soci

ated

with

pat

ient

s’

favo

rabl

e ra

tings

of t

he h

ospi

tal q

ualit

y of

car

e. H

ighe

r par

ticip

atio

n re

duce

d th

e ri

sk o

f exp

erie

ncin

g an

adv

erse

eve

nt.

Wri

ght e

t al.

(201

6), U

K

To d

esig

n, d

evel

op a

nd

eval

uate

five

inno

vativ

e ap

proa

ches

to e

ngag

e pa

tient

s in

pre

vent

ing

PSIs

.

Mul

tiple

met

hods

: Sy

stem

atic

revi

ews,

RC

Ts,

Feas

ibili

ty s

tudy

and

de

velo

ping

a p

rogr

amm

e to

pro

mot

e pa

tient

in

volv

emen

t in

im

prov

ing

safe

ty

(Thi

nkSA

FE)

Patie

nts

are

clea

rly

able

to re

port

on

patie

nt s

afet

y. P

atie

nts

wer

e al

so a

ble

to

iden

tify

a br

oad

rang

e of

con

trib

utor

y fa

ctor

s, w

ith c

omm

unic

atio

n be

ing

the

fact

or m

ost r

ecog

nise

d.

Inte

rvie

win

g at

the

patie

nt’s

bed

side

is li

kely

to b

e th

e m

ost e

ffec

tive

mea

ns o

f ga

ther

ing

patie

nt fe

edba

ck a

bout

the

safe

ty o

f car

e.

Thin

kSA

FE is

a m

ultif

acet

ed in

terv

entio

n th

at is

ext

ensi

vely

use

r inf

orm

ed a

nd

robu

stly

dev

elop

ed. P

relim

inar

y ev

alua

tion

sugg

ests

that

Thi

nkSA

FE is

an

acce

ptab

le a

nd fe

asib

le, l

ow-r

isk

inte

rven

tion

appr

oach

that

has

the

pote

ntia

l for

im

prov

ing

patie

nt s

afet

y.

Appendix 2. Patients’ patient safety incident report form

DIS

SE

RT

AT

ION

S | M

ER

JA S

AH

LS

TR

ÖM

| PA

TIE

NT

PA

RT

ICIP

AT

ION

IN P

RO

MO

TIN

G P

AT

IEN

T S

AF

ET

Y... | N

o 495

uef.fi



ISBN 978-952-61-2960-0ISSN 1798-5706



MERJA SAHLSTRÖM

PATIENT PARTICIPATION IN PROMOTING PATIENT SAFETY - FINNISH PATIENTS’ AND

PATIENT SAFETY EXPERTS’ VIEWS

This study explores patient participation in

the promotion of patient safety using patient-reported patient safety incident reports, patient

safety experts’ views of patient participation and patients’ experiences of safety during their

most recent period of care. Patients’ views of patient safety are generally positive, but the level of patient participation varies among organizations. Patients report diverse types and severities of patient safety incidents, but only few of their reports lead to development

measures in healthcare organizations.

MERJA SAHLSTRÖM

30959335_UEF_Vaitoskirja_NO_495_Merja_Sahlstrom_Terveystiede_kansi_18_11_21.indd 1 21.11.2018 11.19.03