Faculdade de Medicina da Universidade do Faculdade de Medicina da Universidade do PortoPorto

Introdução à MedicinaIntrodução à Medicina

ASTHMA ASTHMA

Is home monitoring more effective Is home monitoring more effective than usual care?than usual care?

Class 19

Coordinator: Dr. João Fonseca

INTRODUCTIONINTRODUCTION

ASTHMAASTHMA

chronic inflammatory disorder of the airwayschronic inflammatory disorder of the airways11

chronically inflamed airways are chronically inflamed airways are hyperresponsive; they become obstructed and hyperresponsive; they become obstructed and airflow is limited (by bronchoconstriction, airflow is limited (by bronchoconstriction, mucus plugs, and increased inflammation) mucus plugs, and increased inflammation) when airways are exposed to various risk when airways are exposed to various risk factorsfactors11

1. “Pocket Guide for Asthma Management and Prevention” www.ginasthma.com

BackgroundBackground

300 million people worldwide now have asthma300 million people worldwide now have asthma11 His control is possible, but it isn’t accomplished in His control is possible, but it isn’t accomplished in

most cases:most cases:- 75% of asthma admissions are avoidable- 75% of asthma admissions are avoidable22

- 40% of asthma patients don’t react properly when their - 40% of asthma patients don’t react properly when their symptoms worsensymptoms worsen22

- 50% of asthma patients admitted with acute asthma - 50% of asthma patients admitted with acute asthma have had alarming symptoms a week before admissionhave had alarming symptoms a week before admission22

- 60% of asthma patients are poor at judging their - 60% of asthma patients are poor at judging their dyspnoeadyspnoea22

1. Global Burden of Asthma Repor

2. Guided self management of asthma - how to do it. Aarzne Lahdensuo

Rationale behind our aimRationale behind our aim

Monitorization between observations at medical Monitorization between observations at medical facilities may:facilities may:– detect early negative events detect early negative events – provide a better insight to the variations of the disease provide a better insight to the variations of the disease – foster patients participation in their own care. foster patients participation in their own care.

Insufficiently known methods and patients’ Insufficiently known methods and patients’ characteristics that have better outcomes with characteristics that have better outcomes with home monitoringhome monitoring

It is necessary summarize the information of the It is necessary summarize the information of the studiesstudies

Systematic reviewSystematic review

– address a specific clinical question address a specific clinical question 11

– require a comprehensive literature search, require a comprehensive literature search, 11

– use explicit selection criteria to identify relevant use explicit selection criteria to identify relevant studiesstudies11

– assess the methodologic quality of included assess the methodologic quality of included studiesstudies11

– explore differences among study resultsexplore differences among study results11

1. Montori VM, Swiontkowski MF, Cook DJ. Methodologic issues in systematic reviews and meta-analyses.

AIMAIM

Primary aimPrimary aim: summarize the available controlled : summarize the available controlled studies about the clinical benefits of asthma studies about the clinical benefits of asthma patients to monitoring their disease outside patients to monitoring their disease outside medical facilities (home monitoring / self-medical facilities (home monitoring / self-monitoring)monitoring)

Secondary aimSecondary aim: to compare the clinical efficacy : to compare the clinical efficacy of different techniques of home monitoringof different techniques of home monitoring

METHODS

Randomised controlled studiesRandomised controlled studies Indexed at SCOPUS and MedlineIndexed at SCOPUS and Medline Assessing the benefits of using home Assessing the benefits of using home

monitoring in patients with asthmamonitoring in patients with asthma

Literature researchLiterature research

PubmedPubmed

(asthm*[MeSH] OR asthm*[TIAB]) (asthm*[MeSH] OR asthm*[TIAB]) AND AND

(((clinical[Title/Abstract] AND trial[Title/Abstract]) OR clinical (((clinical[Title/Abstract] AND trial[Title/Abstract]) OR clinical trials[MeSH Terms] OR clinical trial[Publication Type] OR trials[MeSH Terms] OR clinical trial[Publication Type] OR

random*[Title/Abstract] OR random allocation[MeSH Terms] OR random*[Title/Abstract] OR random allocation[MeSH Terms] OR therapeutic use[MeSH Subheading]))therapeutic use[MeSH Subheading]))

AND AND (("self management"[TIAB] OR ("self care"[TIAB] OR “self (("self management"[TIAB] OR ("self care"[TIAB] OR “self

care”[MeSH]) OR “self-monitoring”[TIAB]) care”[MeSH]) OR “self-monitoring”[TIAB]) AND AND

("peak-flow-meter"[TIAB] OR (spirometry[TIAB] OR ("peak-flow-meter"[TIAB] OR (spirometry[TIAB] OR spirometry[MeSH]) OR telemedicine[TIAB] OR "communication spirometry[MeSH]) OR telemedicine[TIAB] OR "communication

tecnhologies"[TIAB] OR ehealth[TIAB] OR “home automated tecnhologies"[TIAB] OR ehealth[TIAB] OR “home automated telemanagement”[TIAB] OR Internet*[TIAB] OR mobile[TIAB])) telemanagement”[TIAB] OR Internet*[TIAB] OR mobile[TIAB]))

LimitsLimits: : Publication Date 1996-2005, English, Randomized Publication Date 1996-2005, English, Randomized Controlled Trial, Humans Controlled Trial, Humans

ScopusScopus

TITLE-ABS-KEY(*asthma) TITLE-ABS-KEY(*asthma) AND AND

((TITLE-ABS-KEY("self-management" OR "self care" ((TITLE-ABS-KEY("self-management" OR "self care" OR "self-monitoring")) OR "self-monitoring"))

AND AND (TITLE-ABS-KEY("peak-flow-meter" OR spirometry (TITLE-ABS-KEY("peak-flow-meter" OR spirometry OR telemedicine OR "communication technologies" OR telemedicine OR "communication technologies" OR ehealth OR "home outomated telemanagement" OR ehealth OR "home outomated telemanagement"

OR internet OR mobile))OR internet OR mobile)) AND TITLE-ABS-KEY(random* OR trial OR control*)) AND TITLE-ABS-KEY(random* OR trial OR control*))

LimitsLimits: DOCTYPE "ar" AND PUBYEAR 1996-2005: DOCTYPE "ar" AND PUBYEAR 1996-2005

FlowchartFlowchart

FAZER HIPERLIGAÇÂOFAZER HIPERLIGAÇÂO

Inclusion criteriaInclusion criteria

• Articles which describe and evaluate the health care of Articles which describe and evaluate the health care of patients outside hospital, with asthmapatients outside hospital, with asthma

• Articles which compare the clinical outcomes of Articles which compare the clinical outcomes of children and adults with asthma that performed self-children and adults with asthma that performed self-monitoring with those who do not performed self-monitoring with those who do not performed self-monitoringmonitoring

• Not related with our aimNot related with our aimIntervention onlyIntervention only

Pharmacologic treatment; Pharmacologic treatment; Exclusively turned to education of Exclusively turned to education of

patients and professionalspatients and professionals• No control groupsNo control groups• Non-randomizedNon-randomized

Exclusion criteriaExclusion criteria

Data gatheringData gathering

Article data were registered on tables in Article data were registered on tables in RevMan and ExcelRevMan and Excel

RESULTSRESULTS

Articles selectionArticles selection

0

5

10

15

20

25

30

Medline Scopus Both inMedline

and Scopus

Total 1º selection- nº articles

included

2º selection- nº articles

included

Nº

arti

ckes

Excluded articlesExcluded articles

Summary of excluded articlesSummary of excluded articles

12 articles – 12 articles – not related with our aimnot related with our aim

5 articles – not RCT5 articles – not RCT

2 articles – no control group2 articles – no control group

2 articles – 2 articles – full text article not availablefull text article not available

Identification of included articlesIdentification of included articlesArticle ID

Author Tittle Date of publication

Journal/Book/Source

1 Rasmussen, L.M., Phanareth, K., Nolte, H., Backer, V..

Internet-based monitoring of asthma: A long-term, randomized clinical study of 300 asthmatic subjects.

2005 Journal of Allergy and Clinical Immunology

2 Ostojic, V., Cvoriscec, B., Ostojic, S.B., Reznikoff, D., Stipic-Markovic, A., Tudjman, Z..

Improving asthma control through telemedicine: A study of short-message service.

2005 Telemedicine Journal and e-health

3 Wensley, D., Silverman, M..

Peak flow monitoring for guided self-mamagement in childhood asthma: A randomized controlled trial

2004 American Journal of Respiratory and Critical Care Medicine

4 Turner MO, Taylor D, Bennett R, Fitzgerald JM..

A randomized trial comparing peak expiratory flow and symptom self-management plans for patients with asthma attending a primary care clinical.

1998, Feb

AM J Respir Crit Care Med

5 Adams, R.J., Beath, K., Homan, S., Campbell, D.A., Ruffin, R.E..

A randomized trial of peak-flow and symptom-based action plans in adults with moderate-to-severe asthma

2001 Respirology

General information of included articlesGeneral information of included articlesStudy Design Participants Interventions Outcomes Study completion

1Rasmussen L.M., 2005

RCT 300 asthmatic subjects

-questionaries, -spirometry, -measurement of airway responsiveness-internet based monitoring

-symptoms, -quality of life, -lung function, -air responsiveness

2 Ostojic, V,2005

RCT 16 asthmatic subjects

-office visits-1 hour asthma education session with a specialist at the clinic-PEF was to be determined three times per day-asthma monitoring by GSM and SMS

-Events during study period, -Average symptom score, -spirometry, -PEF by time of day (L/min), -PEF variability, -Daily consumption of inhaled medication, Cost of monitoring (per week, per patient) (money and time

3 Wensley, D., 2004

RCT 90 asthmatic children

-spirometry -quality of life -self-management Among 90 participants only one withdrawaled

4 Turner MO, 1998

RCT 92 asthmatic adults

-asthma education-peak expirotory flow-Symptom self-management plans

-ED visits and/or hospitalization for asthma unscheduled -doctor visits, -days absent from school or work courses of prednisone and respiratory tract infections

5 Adams R.J., 2001

RCT 134 asthmatic adults (82 females and 52 males)

-symptom-based action plans -peak expiratory flow

-quality of life -self-management From the original group of one 134 patients, 21(15%) completed between 3 and 5 months of follow-up, 25(19%) between 6 and 11 months and 88(66%) completed the 12 months of follow-up. Among those patients who discontinued the study prior to 12 months 30 gave up due to lack of interest.

Methods of included articlesMethods of included articlesMethods table for included articles

ID article participants' selection methods Participants'selection criteria groups and respective intervention variables analysed instruments for data collection Statistic Analysis1 Letters were posted until 300 asthmatic subjects

had been enrolled. The patients were randomized consecutively by using the sealed enveloped technique, irrespective of computer experience and smoking status, to one of the three groups (Internet group, spe

→subjects aged 18 to 45 years from the catchment area of H:S Bispebjerg University Hospital of Copenhagen, Denmark →asthma was diagnosed on the basis of a combination of respiratory symptoms and at least one objective m

with 3 parallel groups and 2 scheduled visits, 6 month First group: Internet-group (n=100) →They had an electronic diary, an action plan and a decision support system for the phys

→asthma symptoms ─ the severity of symptom was graded as: • Very mild: respiratory symptoms less than once a week and nocturnal symptoms not more than twice a month • Mild: respiratory symptoms 2 to 6 times a week and nocturnal symptoms more than

→The patients were examined on entry into the study and after 6 month of treatment →Questionnaires (all subjects filled in questionnaires on asthma quality life, asthma self-care, smoking habits, education, salary, sick leave and h

→Differences within and between groups were analysed by Wilcoxon signed rank test →On discontinuous variables it was used the contingency X² (p value<0,05)

2 They were rendomized by computer →Patients with moderate persistent asthma for at least 6 months that were being treated with ICS and LABA. →None had a history of smoking, chronic bronchitis, or emphysema.

16 participants divided into 2 groups (1-hour asthma education session with a specialist at the clinic for each patient) First group: SMS study group → they were instructed to send via sms th

→Events during study period (acute respiratory illness, office visits, hospital admission, SMS messages, compliance with PEF measurement (%), PEF values transmitted (% measurealPEP), changes of medication)

→office visits, →PEF was to be determined three times per day and the highest value recorded, →symptom

→The data were analized with the statistic program SPSS →For the continuous variables it was used ANOVA, followed by the 2-simple T-Test to compare the groups and a Paired T-Test fo

3 They were interviewed →age 7-14 years old; →Physician diagnosed asthma; →at least step 2 of the BTSGAM - regular inhaled corticoesteroid therapy , stable threatment for a month, no other respiratory problem,

90 divided in 2 groups First group: S group (n=46) → it was the control group; they had symptom-based management alone for 12 months Second group: IPF gr

→QoL (quality of life) →Lung function →daily symptom score

To QoL: →questionnaires To Spirometry: →VITALOGRAPH

From previous studies, 53 children were needed in each group to have 80% power to detected a between-group difference in daily symptom score of 1,5. The aim was to recruit 120 children (60 in each group) to allow for withdrawals. Details of the statistica

Results of included articlesResults of included articlesArticle ID Aim Main Results Conclusion Final Message1 Investigate the outcome of monitoring and

treatment using a physician-managed online interactive asthma monitoring tool and to access whether the outcomes differs from that of monitoring and treatment in an outpatient clinic and in a primary care

asthma symptoms:→Internet vs specialis: odds ratio of 2.64, p= 0.002;→Internet vs GP: odds ratio of 3.26, p< 0.001;quality of life:→Internet vs specialis: odds ratio of 2.21, p= 0.03;→Internet vs GP: odds ratio of 2.10, p= 0.04;lung function:→I

Demonstrates that asthma is better controlled if patients self-monitoring their symtoms and PEF, follow an written action plan and attend regular control visits to their physician's office. An Internet-based management tool had the potencial of improving

When physicians and patiens used Internet-based asthma monitoring, better asthma control mas achieved.

2 Have access to the feasibility and reability of GSM SMS as a tool of asthma monitoring and to ascertain its impact on control of asthma

→There was no significant difference between the groups in absolute PEF, but PEF variability was significantly smaller in the study group (16.12 +/- 6.93% vs. 27.24 +/- 10.01%, p = 0.049).→forced expiratory flow in 1 second (FEV1; % predicted) in the stu

Despite the limitations and the need for larger confirmatory studies, this study has established feasibility and utility of SMS as a mean of telemedicine of asthma. SMS can contribute to better disease control, symptomatic improvement, and the more favora

SMS as a means of telemedicine of asthma may contribute to better disease control.

3 Compare the efficiency of PEF and symptom self-management plans in patients with asthma

Symptoms scores: no significant differences between the PF and S groupsn the mean daily sympton score during the trial period, the mean daily symptom score for symptomatic day

In children, self-management studies have demonstrated varying degrees of sucess and only three studies directly compared symptoms and peak flow-based management, with inconclusive results at best, during acute exacerbations. During asthma management tr

PEF doesn't have a significant advantage in symptom self-management plans of children with asthma

4 Compare the efficiency of peak expiratory flow and symptom self-management in patients with asthma; Compare the evolution of asthma in patients with or without self-monitoring

→Effect on clinical measurements and quality of life: There was no diference in symptom scores for both goups(p>0.39); Quality of life scores showed a moderate increase for both groups →Effect on medications:There

There is a significant improvement within PFM and symptom groups for measures of spirometry, airway responsiveness, symptoms, and QOF(quality of live). However there was no difference in primary outcome measures between the groups. The use of either a sym

There is no difference in PFM and symptom techiques but both are advantagous when the patients have a proper asthma education.

5 Compare the efficiency of PEF and symptom self-management plans in patients with asthma

→Health care utilization: there was no significant differences between the 2 groups →Lung function: there was no significant differences between the 2 groups

The present study indicates that the choice between using symptom or peak flow-based action plans will depend on the circumstances and preferences of the patient or physician, there is little evidence that the routine use of PFM for asthma self-managemnet

PEF doesn't have a significant advantage in symptom self-management plans of adults asthma

Summary of resultsSummary of results

Clinical benefits of asthma patients to Clinical benefits of asthma patients to monitoring their disease outside medical monitoring their disease outside medical facilities:facilities:– Turner MO, 1998 – positive– Rasmussen L.M., 2005 – positive– Ostojic, V, 2005 - positive

Clinical efficacy of different techniques of Clinical efficacy of different techniques of home monitoring:home monitoring:– Turner MO, 1998 – no significative differences– Wensley, D., 2004 – no significative differences– Adams R.J., 2001 – no significative differences

ACKNOWLEDGEMENTSACKNOWLEDGEMENTS

We would like to thank:We would like to thank:

Dr. João Fonseca because he helped us Dr. João Fonseca because he helped us during our work during our work

Professor Altamiro da Costa Pereira for Professor Altamiro da Costa Pereira for showing us what we should change.showing us what we should change.