Standards to Achieve Reliable Clinical Practice Guidelines

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rlstanley
Posts: 1637
Joined: Mon 3 Dec 2007 2:53

Standards to Achieve Reliable Clinical Practice Guidelines

Post by rlstanley » Mon 4 Apr 2011 17:30

http://www8.nationalacademies.org/onpin ... rdID=13058

IOM Recommends Standards to Achieve Reliable Clinical Practice Guidelines and High-Quality Systematic Reviews of Evidence

Date: March 23, 2011
FOR IMMEDIATE RELEASE

WASHINGTON — Clinical practice guidelines and systematic reviews of the evidence base for health care services are supposed to offer health care providers, patients, and organizations authoritative guidance on the comparable pros and cons of various care options, but too often they are of uncertain or poor quality. There are no universally accepted standards for developing systematic reviews and clinical practice guidelines, leading to variability in the handling of conflicts of interest, appraisals of evidence, and the rigor of the evaluations. Two new reports from the Institute of Medicine recommend standards to enhance the quality and reliability of these important tools for informing health care decisions (see illustration).

Clinical Practice Guidelines We Can Trust recommends eight standards to ensure the objective, transparent development of trustworthy guidelines. Several problems hinder providers' and others' ability to determine which among thousands of sometimes competing guidelines offer reliable clinical recommendations. Finding What Works in Health Care: Standards for Systematic Reviews recommends 21 standards to ensure objective, transparent, and scientifically valid reviews. Poor quality reviews can lead clinicians to the wrong conclusions and ultimately to inappropriate treatment decisions.

"These standards are necessary given that there is little documentation to judge the quality and reliability of many of the existing clinical practice guidelines," said Sheldon Greenfield, Donald Bren Professor of Medicine and executive director, Health Policy Research Institute, University of California, Irvine, and chair of the committee on guidelines. "Practice guidelines provide valuable data and guidance that not only inform individual decisions about care but ultimately could also improve overall health care quality and outcomes."

"This report presents the 'gold standard' to which those who conduct systematic reviews should aspire to achieve the most reliable and useful products," said Alfred O. Berg, professor of family medicine, University of Washington School of Medicine, Seattle, and chair of the committee that wrote the report on systematic reviews. "We recognize that it will take an investment of resources and time to achieve such high standards, but they should be adopted to minimize the chances that important health decisions are based on information that may be biased or erroneous."

To prevent actual or perceived conflicts of interest from eroding trust in clinical practice guidelines, members of guideline development groups should not have intellectual, institutional, financial, or other forms of conflicts whenever possible, says the guidelines report. However, if a group cannot perform its work without conflicted individuals, they should make up only a minority of the members. Those who fund guideline development work should have no role in the development process. Similarly, individuals with clear financial conflicts of interest as well as those with professional or intellectual biases that would lessen an evaluation's credibility should be excluded from the teams that conduct systematic reviews, the report on reviews says.

Getting input from consumers, health professionals, insurers, and other intended users can boost the quality of reviews and guidelines and make them more relevant. Guideline development groups should include a current or former patient and a patient advocate or representative of a consumer organization. Systematic reviews should include a method to collect information from individuals with relevant perspectives and expertise. Individuals providing input should publicly acknowledge their potential biases and conflicts and be excluded from the process if their participation would diminish the evaluation’s credibility.

People expect clinical practice guidelines to provide an accurate, fair account of the potential benefits and harms of various health care options and they expect systematic reviews to provide a complete picture of all that is known about an intervention. Because guideline developers often have to make subjective judgments about evidence, especially when it is low-quality or limited, they should explicitly describe the part that value judgments, theory, or clinical experience played in their recommendations, the guidelines report says. They should explain the reasoning underlying each recommendation they make, including their assessment of the quality, completeness, and consistency of the available evidence. Teams conducting systematic reviews should not limit their evaluations to the published literature or large databases because negative findings sometimes go unpublished and these tools provide only a partial picture of the evidence, the report on reviews says. Reviewers should seek out relevant unpublished information. And they should clearly describe the team's methodology, selection criteria, and assessment of the evidence, including what remains unknown about the topic.

The studies were requested by Congress and sponsored by the U.S. Department of Health and Human Services. Established in 1970 under the charter of the National Academy of Sciences, the Institute of Medicine provides independent, objective, evidence-based advice to policymakers, health professionals, the private sector, and the public. The National Academy of Sciences, National Academy of Engineering, Institute of Medicine, and National Research Council make up the National Academies. For more information, visit http://national-academies.org or http://iom.edu. Committee rosters follow.

Contacts:

Christine Stencel, Senior Media Relations Officer
Luwam Yeibio, Media Relations Assistant
Office of News and Public Information
202-334-2138; e-mail news@nas.edu



Additional resources:

Report Brief for Practice Guidelines
Report Brief for Systematic Reviews
Illustration
Practice Guidelines Website
Systematic Reviews Website

rlstanley
Posts: 1637
Joined: Mon 3 Dec 2007 2:53

Re: Standards to Achieve Reliable Clinical Practice Guidelin

Post by rlstanley » Mon 4 Apr 2011 20:52

The U.S. Congress, through the Medicare Improvements for Patients and Providers Act of 2008, asked the IOM to undertake a study on the best methods used in developing clinical practice guidelines. The IOM developed eight standards for developing rigorous, trustworthy clinical practice guidelines.

The complete list of standards:

http://iom.edu/Reports/2011/Clinical-Pr ... dards.aspx

Standards for Developing Trustworthy Clinical Practice Guidelines
STANDARD 1
Establishing transparency


1.1 The processes by which a CPG is developed and funded should be detailed explicity and publicly accessible.

STANDARD 2
Management of conflict of interest (COI)


2.1 Prior to selection of the Guideline Development Group (GDG), individuals being considered for membership should declare all interests and activities potentially resulting in COI with development group activity, by written disclosure to those convening the GDG.

Disclosure should reflect all current and planned commercial (including services from which a clinician derives a substantial proportion of income), non-commercial, intellectual, institutional, and patient/public activities pertinent to the potential scope of the CPG.

2.2 Disclosure of COIs within GDG

All COI of each GDG member should be reported and discussed by the prospective development group prior to the onset of their work.

Each panel member should explain how their • COI could influence the CPG development process or specific recommendations.

2.3 Divestment
Members of the GDG should divest themselves of financial investments they or their family members have in, and not participate in marketing activities or advisory boards of, entities whose interests could be affected by CPG recommendations.

2.4 Exclusions

Whenever possible GDG members should not have COI.
In some circumstances, a GDG may not be able to perform its work without members who have COIs, such as relevant clinical specialists who receive a substantial portion of their incomes from services pertinent to the CPG.

Members with COIs should represent not more than a minority of the GDG.
The chair or co-chairs should not be a person(s) with COI.
Funders should have no role in CPG development.



STANDARD 3
Guideline development group composition

3.1 The GDG should be multidisciplinary and balanced, comprising a variety of methodological experts and clinicians, and populations expected to be affected by the CPG.

3.2 Patient and public involvement should be facilitated by including (at least at the time of clinical question formulation and draft CPG review) a current or former patient and a patient advocate or patient/consumer organization representative in the GDG.

3.3 Strategies to increase effective participation of patient and consumer representatives, including training in appraisal of evidence, should be adopted by GDGs.


STANDARD 4
Clinical practice guideline–systematic review intersection


4.1 CPG developers should use systematic reviews that meet standards set by the Institute of Medicine’s Committee on Standards for Systematic Reviews of Comparative Effectiveness Research.

4.2 When systematic reviews are conducted specifically to inform particular guidelines, the GDG and systematic review team should interact regarding the scope, approach, and output of both processes.
STANDARD 5
Establishing evidence foundations for and rating strength of recommendations


5.1 For each recommendation, the following should be provided:

An explanation of the reasoning underlying the recommendation, including:

A clear description of potential benefits and harms.

A summary of relevant available evidence(and evidentiary gaps), description of the quality (including applicability), quantity (including completeness), and consistency of the aggregate available evidence.

An explanation of the part played by values, opinion, theory, and clinical experience in deriving the recommendation.

A rating of the level of confidence in (certainty regarding) the evidence underpinning the recommendation.

A rating of the strength of the recommendation in light of the preceding bullets.

A description and explanation of any differences of opinion regarding the recommendation.



STANDARD 6
Articulation of recommendations


6.1 Recommendations should be articulated in a standardized form detailing precisely what the recommended action is and under what circumstances it should be performed.

6.2 Strong recommendations should be worded so that compliance with the recommendation(s) can be evaluated.


STANDARD 7
External review


7.1 External reviewers should comprise a full spectrum of relevant stakeholders, including scientific and clinical experts, organizations (e.g., health care, specialty societies), agencies (e.g., federal government), patients, and representatives of the public.

7.2 The authorship of external reviews submitted by individuals and/or organizations should be kept confidential unless that protection has been waived by the reviewer(s).

7.3 The GDG should consider all external reviewer comments and keep a written record of the rationale for modifying or not modifying a CPG in response to reviewers’ comments.

7.4 A draft of the CPG at the external review stage or immediately following it (i.e., prior to the final draft) should be made available to the general public for comment. Reasonable notice of impending publication should be provided to interested public stakeholders.


STANDARD 8
Updating


8.1 The CPG publication date, date of pertinent systematic evidence review, and proposed date for future CPG review should be documented in the CPG.

8.2 Literature should be monitored regularly following CPG publication to identify the emergence of new, potentially relevant evidence and to evaluate the continued validity of the CPG.

8.3 CPGs should be updated when new evidence suggests the need for modification of clinically important recommendations. For example, a CPG should be updated if new evidence shows that a recommended intervention causes previously unknown substantial harm, that a new intervention is significantly superior to a previously recommended intervention from an efficacy or harms perspective, or that a recommendation can be applied to new populations.

rlstanley
Posts: 1637
Joined: Mon 3 Dec 2007 2:53

Re: Standards to Achieve Reliable Clinical Practice Guidelin

Post by rlstanley » Mon 4 Apr 2011 21:49

http://www.iom.edu/Reports/2011/Clinica ... Brief.aspx
The Guidelines International Network database currently contains more than 3,700 clinical practice guidelines from 39 countries. Additionally, there are nearly 2,700 guidelines in the National Guidelines Clearinghouse (NGC), part of the Agency for Healthcare Research and Quality (AHRQ). Because of the large number of clinical practice guidelines available, guideline users, including practitioners, find it challenging to determine which guidelines are of high quality....

Most guidelines used today suffer from shortcomings in development. Dubious trust in guidelines is the result of many factors, including failure to represent a variety of disciplines in guideline development groups, lack of transparency in how recommendations are derived and rated, and omission of a thorough external review process.

minitails2
Posts: 1001
Joined: Sat 3 Nov 2007 10:27

Re: Standards to Achieve Reliable Clinical Practice Guidelin

Post by minitails2 » Tue 12 Apr 2011 7:02

Unfortunately, it sounds like we as patients shouldn't put too much belief into existing guidelines of all types. We're really kind of on our own aren't we?

rlstanley
Posts: 1637
Joined: Mon 3 Dec 2007 2:53

Re: Standards to Achieve Reliable Clinical Practice Guidelin

Post by rlstanley » Thu 14 Apr 2011 16:53

minitails2 wrote:Unfortunately, it sounds like we as patients shouldn't put too much belief into existing guidelines of all types. We're really kind of on our own aren't we?

Belief?

Science is the belief in the ignorance of the experts
--Richard Feynman


On your own?

As with most complex things, you might want to drive the show yourself. Choose wisely.
.

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