Final Accreditation Report - for guidance and advice for ... · standards in producing health or social care guidance. ... (Micromedex drug solutions ... As the focus of

Truven Health Analytics - content database: Final Accreditation Report

Guidance

producer:

Truven Health Analytics

Guidance

product:

Content database

Date: 15 March 2013

Version: 1.6

Final Accreditation Report - for guidance and advice for use

in decision support systems

Truven Health Analytics – content database: Final Accreditation Report

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Contents

Introduction ..................................................................................................................... 3

Accreditation recommendation ........................................................................................ 3

Implementation ................................................................................................................ 6

Appendix A: NICE Accreditation analysis ........................................................................ 7

Appendix B: Bibliography .............................................................................................. 17

Appendix C: NICE Accreditation Advisory Committee, external advisers and NICE

Accreditation team......................................................................................................... 19


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Introduction

The NICE Accreditation Scheme recognises organisations that demonstrate high

standards in producing health or social care guidance. Users of the accredited guidance

can therefore have high confidence in the quality of the information. Organisations may

publicly display a seal of approval called an Accreditation Mark for 5 years after their

processes have been accredited. The process for accrediting producers of guidance

and recommendations for practice is described in the process manual.

Accreditation recommendation

NICE has accredited the process used by Truven Health Analytics to produce its

content database. Accreditation is valid for 5 years from March 2013.

Background to the guidance producer

Truven Health Analytics is a health analytical company specialising in clinical decision

support, pharmaceuticals data, Government healthcare analytics global data, employer

data and research. This application is for the processes used to develop and maintain

the clinical information in an online database (Micromedex drug solutions – Drugdex

Evaluations and Drug Points), which assists clinicians to make informed and safe

decisions about patients’ medication and care management at the point of care.

Summary

The accreditation programme is piloting the use of the accreditation criteria and process

to assess how content is developed for a range of clinical decision support systems.

Because the content in the database is part of a clinical decision support system, it is

not accessible on the NICE website.

http://www.nice.org.uk/aboutnice/accreditation/AccreditationProcess.jsp?domedia=1&mid=F4FBA601-AA1E-E42E-019AC9951DB631D6

http://www.nice.org.uk/


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The content in the database can be integrated into an electronic patient record system

but is primarily a stand-alone product that functions in isolation. The accreditation

assessment did not evaluate the algorithms or software that underpin Micromedex.

The Accreditation Advisory Committee considered that the processes used by Truven

Health Analytics to produce the content in its database complied with 22 of the 23

applicable accreditation criteria.

Criterion 2.2 (seeks patient views and preferences in developing guidance) was found

to be not fully met because direct patient involvement is not part of the database content

editorial process. The views of patients may have been addressed in the production of

the primary content included in the database but, where this is not the case, patient

involvement will be lacking in relation to Micromedex content.

Criterion 5.2 (potential organisational and financial barriers to implementation) is not

applicable because the guidance producer does not create data. Organisational or

financial barriers are outside the scope of the criterion. Truven identifies published

evidence related to alternative therapies, evaluates the quality, and selects the best

available evidence applicable to content.

Criterion 5.3 is not applicable because the monitoring/auditing of prescribing data,

along with improvements in patient safety and outcomes cannot be explicitly linked back

to the content in the database alone.

The database facilitates the safe prescribing of both on- and off-label medicines in

terms of dosing, interactions with other drugs, adverse effects and efficacy so clinicians

can make informed diagnosis and treatment decisions. The Editorial Group is

comprised of physicians, clinical pharmacists and nurses and performs searches for

content using various electronic databases. Truven receives income from customers

who buy its products following their promotion in press releases and on its website.

Before employing advisers, Truven collects information on the advisers’ financial

relationships with pharmaceutical companies.


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Suggestions for further improvements to strengthen the Truven Health Analytics

process for producing the content in its content database include:

the active involvement of patients in the editorial process to improve the patients’

perspective on drug prescribing and safety

drugs being listed under their generic or international non-proprietary name (INN)

so that they can be recognised globally.

Professor David Haslam CBE

Chair, Accreditation Advisory Committee

March 2013


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Implementation

Following accreditation, the accredited producer will be able to display the Accreditation

Mark on its website (see Figure 1). The accredited guidance producer is also granted a

royalty-free, worldwide licence to use the NICE Accreditation Mark in accordance with

the Conditions and Terms of Use. Providing these conditions are met, a guidance

producer's accreditation will last for 5 years from publication of approval on the NICE

website.

Accredited guidance producers must take reasonable steps to ensure the accredited

processes are followed when generating the type of evidence for which they are

accredited. Accredited guidance producers should have quality assurance mechanisms

in place and must inform NICE Accreditation within 30 days if any significant change is

made to a process.

Figure 1: The Accreditation Mark

http://www.nice.org.uk/media/F4F/A6/ConditionsOfAccreditation.pdf




Appendix A: NICE Accreditation analysis

The Accreditation Advisory Committee considered the following analysis of the guidance producer’s compliance with NICE

Accreditation criteria, which covers 6 discrete domains. The full analysis leading to the accreditation decision is shown

below.

Criterion Evidence for meeting the criterion Accreditation

decision

Scope and

purpose

Does the guidance producer have a policy in place and adhered to that requires them to explicitly detail:

1.1 Overall objective The ‘Micromedex suite’a document states that the purpose of the content

database is to assist clinicians to make informed, safe and self-assured

decisions about patients’ medication and care management at the point

of care.

Criterion met

1.2 The clinical, healthcare or social questions covered

The ‘Micromedex suite’a document states that the guidance helps clinicians

select the correct medication and dosage taking into consideration drug

interactions based on automated searches of the evidence base. The use of

the content database facilitates safe prescribing of both on- and off-label

medicines. In this context, the ‘clinical questions’ are those that relate to the

safe use of medication.

Criterion met


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decision

1.3 Population and/or target audience to whom the guidance applies

The ‘Micromedex solutions’b document states that the target audience is

physicians, pharmacists, nurses and other allied health professionals

who deliver patient care. The population covered by the content

database is high level – namely, adult and paediatric patients presenting

to clinicians – but it is further subdivided for specific circumstances.

Criterion met

1.4 Guidance includes clear recommendations in reference to specific clinical, healthcare or social circumstances

The ‘Dosing and administration style guide’c details the types of studies that

are considered for inclusion in the content database. According to ‘The power

of Micromedex to evaluate therapeutic use’d, each indication is assigned a

set of three ratings (efficacy, strength of evidence and strength of

recommendation). When the three ratings are combined, they help clinicians

make decisions on whether to prescribe a drug for an indication.

Criterion met


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decision

Stakeholder

involvement

Does the guidance producer have a policy in place and adhered to that means it includes:

2.1 Individuals from all relevant stakeholder groups, including patient groups, in developing guidance

Approximately 90 physicians, clinical pharmacists, nurses and other allied

health professionals comprise the Editorial Group according to the

‘Micromedex editorial workflow’e The Editorial Group works across the

disciplines of internal medicine, oncology, geriatrics, paediatrics, emergency

medicine, toxicology, clinical pharmacokinetics and alternative medicine.

Truven does not actively or directly involve patients in the development of

guidance and the component of the criterion that assesses patient

stakeholders is not applicable.

Criterion met

2.2 Patient and service user representatives and seeks patient views and preferences in developing guidance

Truven is not the primary author of the recommendations made in the

database and it does not edit content. Patients can provide feedback but

not direct patient input because their involvement is not part of the

editorial process. The views of patients may have been addressed in the

original guidance production process but, if this was not the case, patient

involvement will also be lacking in the content database. As the focus of

this criterion is to include patients’ views when producing

recommendations, this criterion is not fully met.

Not fully met


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decision

2.3 Representative intended

users in developing

guidance

The ‘Micromedex editorial workflow’e document shows that the clinicians

involved in developing guidance are from a wide range of specialties such as

internal medicine, oncology, geriatrics, paediatrics, emergency medicine,

toxicology, clinical pharmacokinetics and alternative medicine. Editorial staff

devise and review the recommendations, and they are representative of the

intended users because they are from the same professional backgrounds.

Criterion met

Rigour of

development

Does the guidance producer have a clear policy in place that:

3.1 Requires the guidance

producer to use

systematic methods to

search for evidence and

provide details of the

search strategy

According to the ‘Micromedex weekly literature alert process’f, weekly

searches for content are performed. Medical subject headings (MeSH) terms

and free text are used to search and an example searchg was provided. The

‘Literature evaluation procedure’h document states that the literature search

process involves a 2-step systematic approach for selecting the most

important evidence-based research. The ‘Off-label library process’i document

details further search examples.

Criterion met


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decision


producers to state the

criteria and reasons for

inclusion or exclusion of

evidence identified by the

evidence review

The ‘Literature evaluation procedure’h document states that clinicians

examine the titles and abstracts of searches to ascertain whether

evidence meets the inclusion criteria. If abstract evidence looks

acceptable, the full article is evaluated further. The ‘Off-label library

process’i document states that the search strategy is limited to studies

written in the English language that include human subjects. The

‘Micromedex search example’g shows implementation of these search

inclusion and exclusion parameters.

Criterion met

3.3 Describes the strengths

and limitations of the

body of evidence and

acknowledges any areas

of uncertainty

The policy for evaluating the strengths and weaknesses of evidence can be

confirmed from the ‘Literature evaluation procedure’h. Three different rating

scales (strength of evidence, efficacy rating, strength of recommendation) are

used to evaluate evidence. Evidence deemed uncertain or inconclusive is

specified. The ‘Therapeutic uses’j document acknowledged that high-quality

randomised controlled trials are not available for all areas.. The ‘Dosing and

administration style guide’c shows screenshots of how therapeutic user

ratings are chosen from the content of the information appearing in the

database.

Criterion met


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decision

3.4 Describes the method

used to arrive at

recommendations (for

example, a voting system

or formal consensus

techniques like Delphi

consensus)

Micromedex editorial staff are responsible for initial creation or revision of

content. A clinical staff member performs an internal review of all new content

and ensures it is accurate. Feedback is provided to authors and this process

can repeat a number of times prior to sign-off and feedback from the Editorial

Board. In cases of disagreement, editors discuss the evidence and come to a

consensus on the final text and ratings. An ‘Off-label indications policy’k

outlines an additional step that involves approval by 5 Off-label Review Board

members.

Criterion met


producers to consider the

health benefits against

the side effects and risks

in formulating

recommendations

The ‘Warnings and precautions style guide’l states that situations or

populations in which the risk of using a drug outweighs possible benefits are

provided. The purpose of safety alert warnings on drug labels is to minimise

risks by alerting clinicians to the harm potential. Safety warnings are

regulatory and signify that clinical studies have shown that a particular drug

carries a significant risk of serious or life-threatening adverse effects.

Criterion met

3.6 Describes the processes

of external peer review

The peer review process can be verified by the ‘Core drug information style

guide’m and the ‘Micromedex editorial workflow’

e document. Feedback is

provided to each authoring unit and this process may be repeated a number

of times before progressing to a final clinical review. The peer review process

is external to the team that created the content.

Criterion met


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decision

3.7 Describes the process of

updating guidance and

maintaining and

improving guidance

quality

The ‘Micromedex editorial workflow’e document states that ongoing literature

surveillance is monitored daily. The ‘Micromedex weekly literature alert

process’f states that alerts are reviewed to identify new evidence that could

add value to existing content.

Criterion met

Clarity and

presentation

Does the guidance producer ensure that:

4.1 Recommendations are

specific, unambiguous

and clearly identifiable

The ‘Literature evaluation procedure’h document defines literature ratings for

strength of evidence, efficacy and strength of recommendation. The ‘Dosing

and administration style guide’c depicts screenshots showing therapeutic use

ratings for efficacy, strength of recommendation and strength of evidence.

Recommendations are written in the active voice and passive verbs should

be avoided. There are example screenshots throughout the style guides

showing recommendations that are specific, unambiguous and clearly

identifiable.

Criterion met

4.2 Different options for the

management of the

condition or options for

intervention are clearly

presented

It can be confirmed that both the ‘Comparative efficacy style guide’n and the

‘Place in therapy style guide’o support the guidance producer’s submission to

this criterion. The authoring unit describes how individual drugs compare with

other drugs in terms of their therapeutic effects to treat the same or different

conditions when relevant. The differences in terms of adverse and

pharmacodynamic effects are provided for each drug.

Criterion met


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decision

4.3 The date of search, the

date of publication or last

update and the proposed

date for review are clearly

stated

The date that searches for evidence were performed is not provided but

searches are automatically rerun so this is deemed acceptable. The last

modified date is clearly shown on the ‘Micromedex screenshot 2’p. The

proposed date for future review is defined in the process documentation.

Criterion met

4.4 The content of the

guidance is suitable for

the specified target

audience. If patients or

service users are part of

this audience, the

language should be

appropriate.

The content, style and language of the examples included in the Micromedex

screenshotsp,q

show that Drugdex Evaluations and Drug Points content is

suitable for the intended audience of clinicians. Patients are not part of the

target audience but they can provide feedback on patient education materials

through their healthcare providers.

Criterion met

Applicability

Does the guidance producer routinely consider:

5.1 Publishing support tools

to aid implementation of

guidance

The Micromedex products can be considered as support tools to assist

clinicians in prescribing drugs. ‘Training opportunities’r shows that training is

available to help users become proficient in using Micromedex products.

Criterion met

5.2 Discussion of potential

organisational and

financial barriers in

applying its

recommendations

The database is only accessible to clinicians working for healthcare providers

who have purchased the system. The guidance producer does not create

data. It identifies published evidence related to alternative therapies,

evaluates the quality and selects the best available evidence applicable to

content. Organisational or financial barriers are outside the scope of the

criterion.

Not applicable

http://www.micromedex.com/mdxtraining


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decision

5.3 Review criteria for

monitoring and/or audit

purposes within each

product

The monitoring and auditing of improvements in patient safety, outcomes and

prescribing data cannot be explicitly linked back to the content in the

database.

Not applicable

Editorial

independence

Does the guidance producer:

6.1 Ensure editorial

independence from the

funding body

Before employing advisers, Truven collects information on their advisers’

financial relationships with pharmaceutical companies. Although an editorial

team is employed by Truven, the processes are such that editorial

independence is retained.

Criterion met

6.2 Demonstrate

transparency about the

funding mechanisms for

its guidance

The guidance producer is an independent company and receives income

from customers who buy its products following their promotion in the Press

releases and on the company website.

Criterion met

6.3 Record and state any

potential conflicts of

interest of individuals

involved in developing

the recommendations

The Conflict of interest policyt shows that all financial conflicts of interest are

declared annually and encompass interests in pharmaceutical companies,

the financial interests of the worker and their partner. The main exclusions to

being involved in the development of content in the database include being a

current or recent pharmaceutical company employee or owning a large

number of pharma shares.

Criterion met

http://thomsonreuters.com/content/press_room/healthcare/acquisition_hc_business_tr_veritas_capital


http://www.micromedex.com/evidence/collateral/ed_ConflictofInterest.pdf


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decision

6.4 Take account of any

potential for bias in the

conclusions or

recommendations of the

guidance

The guidance producer has a range of processes and policies that limit the

potential for bias, including how evidence is identified and included or

excluded. Other steps that minimise bias include the process for updating

guidance, searching and reviewing, and the risk management policy, the

rigorous conflict of interests policyt and the peer review strategy.

Criterion met

a Micromedex suite

b Micromedex solutions

c Dosing and administration style guide

d The power of Micromedex to evaluate therapeutic use

e Evidence process document (Micromedex editorial workflow)

f Micromedex weekly literature alert process g Micromedex search example

h Literature evaluation procedure

i Off-Label library process j Therapeutic uses k Off-label indications policy

l Warnings and precautions style guide m Core drug information style guide

n Comparative efficacy style guide

o Place in therapy style guide

p Micromedex screenshot 2

q Micromedex screenshot 1

r Training opportunities

s Press release

t Conflict of interest policy


http://www.micromedex.com/mdxtraining




Appendix B: Bibliography

Appendix B lists the additional information taken into account in the analysis and

considered by the Committee.

Document name Description Location

Micromedex suite

Process document Supplied

Therapeutic uses

Process document http://www.micromedex.com/evidence/collateral/therapeutic_use.pdf

The power of Micromedex to evaluate therapeutic use

Process document http://interest.healthcare.thomsonreuters.com/content/CDS11V2Newsletter-Feature1

Dosing and administration style guide


Micromedex screenshot 1


Micromedex solutions


Literature evaluation procedure


Evidence process document (Micromedex editorial workflow)

Process document http://www.micromedex.com/evidence/collateral/editorial_process.pdf

Off-label library process


Micromedex weekly literature alert process


Micromedex search example


Off-label indications policy


Comparative efficacy style guide Process document Supplied

Adverse effects style guide


Warnings and precautions style guide


Core drug information master style guide


Monitoring style guide


Reproductive risk style guide


Place in therapy style guide


Micromedex screenshot 2 Process document Supplied

Core Drug Information (CDI) master style guide


Training opportunities

Process document http://www.micromedex.com/mdxtraining/

Conflict of interest policy

Process document http://www.micromedex.com/evidence/collateral/ed_ConflictofInterest.pdf

Financial disclosure form Process document Supplied

http://www.micromedex.com/evidence/collateral/therapeutic_use.pdf

http://www.micromedex.com/evidence/collateral/therapeutic_use.pdf

http://interest.healthcare.thomsonreuters.com/content/CDS11V2Newsletter-Feature1



http://www.micromedex.com/evidence/collateral/editorial_process.pdf

http://www.micromedex.com/evidence/collateral/editorial_process.pdf

http://www.micromedex.com/mdxtraining/

http://www.micromedex.com/mdxtraining/





Page 18 of 21

Document name Description Location

Press release Process document http://thomsonreuters.com/content/press_room/healthcare/acquisition_hc_business_tr_veritas_capital

Compendia transparency information

Process document http://thomsonreuters.com/products_services/healthcare/healthcare_products/clinical_deci_support/compendia_transparency/

Micromedex: Core Drug Information (CDI) workflow procedure


Senior clinical content specialist off-label process document


Off-label indications board review

process training


Clinical content specialist off-label process document





http://thomsonreuters.com/products_services/healthcare/healthcare_products/clinical_deci_support/compendia_transparency/





Page 19 of 21

Appendix C: NICE Accreditation Advisory Committee,

external advisers and NICE Accreditation team

NICE Accreditation Advisory Committee

The NICE Accreditation Advisory Committee operates as a standing advisory committee

of the Board of the National Institute for Health and Clinical Excellence (NICE). The

Committee provides advice to NICE on a framework for accrediting sources of evidence

that should be recognised as trusted sources of information for the NHS. The Chair of

the Committee is appointed by the NICE Board and the meetings are conducted by the

chair or in his/her absence the vice chair. The current Chair is David Haslam. A full list

of the Accreditation Advisory Committee membership is available on the NICE website.

Members are appointed for a period of 3 years. This may be extended by mutual

agreement for a further 3 years, up to a maximum term of office of 10 years.

The decisions of the Committee are arrived at by a consensus of the members present.

The quorum is set at 50% of committee membership. The Committee submits its

recommendations to the NICE Publications executive which acts under delegated

powers of the NICE Board in considering and approving its recommendations.

Committee members are asked to declare any interests in the guidance producer to be

accredited. If it is considered that there is a conflict of interest, the member(s) is

excluded from participating further in the discussions. Committee members who took

part in the discussions for this accreditation decision are listed below.

Title Name Surname Role Organisation

Mr Jim Blair Consultant Nurse Learning

Disabilities

St. George’s Healthcare NHS

Trust

Dr Adrian Brown Consultant in Public Health

Medicine

Inner North West London PCTs

Professor Ann Caress Professor of Nursing/Director

of Postgraduate Research

Programmes

University of Manchester



Page 20 of 21

Ms Ailsa Donnelly Lay member

Ms Amanda Edwards Deputy Chief Executive Social Care Institute for Excellence

Ms Joyce Epstein Lay member

Professor David Haslam National Clinical Adviser Care Quality Commission

Dr Bobbie Jacobson Director of London Health Observatory and Vice Chair of PH Observatories

London Health Observatory

Professor Monica Lakhanpaul Consultant Community Paediatrician/Senior Lecturer in Child Health

Leicestershire Partnership Trust

Dr Edward Ng General Practitioner Ley Hill Surgery

Dr Donal O’Donoghue National Clinical Director for

Kidney Care and Consultant

Renal Physician

Salford Royal NHS Foundation

Trust

Professor Sandy Oliver

Professor of Public Policy, Deputy Director, Social Science Research Unit, Cochrane Consumers and Communications Review Group

University of London

Dr Carl Parker Primary Care Medical Adviser North Tees and Hartlepool

Foundation Trust

Dr Mahendra Patel Research Fellow, Senior Lecturer and Community Pharmacist

Universities of Huddersfield and Bradford

Dr Karen Ritchie Head of Knowledge

Management

Healthcare Improvement

Scotland

Professor Sasha Shepperd Professor of Health Services

Research

University of Oxford

Dr Mark Strong MRC Fellow Section of Public Health, SCHARR

Ms Gill Swash Head of Knowledge and Library Services

NHS Western Cheshire


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External Advisers for Truven Health Analytics: content database

accreditation application

Cheryl Harding –Trestrail, Clinical Commissioning Lead for Long Term Conditions, West

Hampshire, Clinical Commissioing Group, UK

Kristiina Patja, Adjunct Professor, Director, Pro Medico (the Association for Medical

Continuous Professional Development) Finland

Dr Patrick Hamilton, Glomerular Diseases and Vasculitis Fellow, Manchester Royal

Infirmary., Manchester, UK Assistant Researcher, Leeds Institute of Health Sciences,

Leeds, UK

NICE Accreditation team for Truven Health Analytics: content

database accreditation application

John Huston, Accreditation Technical Analyst, National Institute for Health and Clinical

Excellence, Manchester, UK.

Stephanie Birtles, Accreditation Technical Analyst, National Institute for Health and

Clinical Excellence, Manchester, UK.

Documents

Final Accreditation Report - for guidance and advice for ... · standards in producing health or social care guidance. ... (Micromedex drug solutions ... As the focus of