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The Clinical Practice Guidelines Development Process

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The Clinical Practice Guidelines Development Process

July 2006

Clinical practice guidelines (CPG) advance the mission of the American Academy of Audiology (Academy) by providing a framework of clinical recommendations to audiologists for the express purpose of providing state-of-the-art care for individuals with hearing and balance disorders. CPG have been defined as “systematically developed statements to assist practitioner and patient decisions about appropriate health care for specific clinical circumstances” (Committee to Advise the Public Health Service on Clinical Practice Guidelines, Institute of Medicine, 1990). More specifically, well-developed guidelines have the potential to (1) enhance current, appropriate clinical practice; (2) improve the quality of audiologic diagnostic assessment and treatment; (3) result in better patient outcomes; (4) improve cost-effectiveness of the care; and (5) identify areas requiring further investigation. These recommendations should be provided in a manner that affords the practitioner a more complete understanding of the topical evidence available for each condition, procedure, and treatment option presented.

The Academy supports the creation of evidence-based CPG to ensure applicable and clear recommendations that guide clinical practice. Evidence-based practice is described as integrating individual clinical expertise with the best available external clinical evidence (Sackett et al, 1996). Accordingly, the clinical recommendations proposed by the CPG reflect a systematic literature search and review of existing scientific evidence published in peer-reviewed journals as well as the expertise of subject matter experts. To this end, CPG define an optimum level of patient care and are used to promote and ensure standardization in clinical practice across audiologists and groups of audiologists. Accordingly, the essential characteristics of good guidelines should rest on an analysis of available scientific evidence, be reliable, have applicability for clinical populations, and be updated periodically to reflect current knowledge and state-of-the-art practice (Bakal, 2000).

The development of a new CPG typically results from a request by a member or members of the Academy. Alternatively, the Board of Directors (BOD) may identify a gap in the standardization of current clinical practice. The relevance and timeliness of all requests are considered by the chair of the Strategic Documents Committee and presented to the BOD for consideration. A recognized expert from the Academy membership is identified by the BOD to serve as chair of the task force. Subsequently, the president contacts the individual to determine whether he or she will serve as the task force chair. Once accepted, the new task force chair is contacted by the chair of the Strategic Documents Committee to determine appropriate timelines for the development and completion of the CPG. It is the responsibility of the task force chair to recruit other Academy members to serve on the task force and create the CPG. Members of the task force must be current members of the Academy. Other clinical scientists and or practitioners who are not eligible for membership in the Academy may serve as consultants to the task force. In Table 1, questions are presented for consideration and as a basis to initialize the duties of the task force.

Table 1. Questions for Consideration by the Task Force

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What is the purpose of the CPG?
What is the CPG targeted procedure or intervention?
What are the important clinical objectives related to the CPG topic?
What is the target patient population?
Are there potential benefits and/or risks for individual patients associated with the procedure or treatment?
Who are the CPG’s intended users/stakeholders?
What is the epidemiology of the topic?
Will the new CPG be related in any manner to existing guidelines established by the Academy?
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The draft document written by the task force will receive critical appraisal through a select peer review process whereby non–task force Academy members will be contacted and asked to read and comment on the draft guideline. Following select peer review, the revised draft document will be posted on the Academy Web site for widespread peer review for a period of 30 days. All comments received will be forwarded to the task force chair and disseminated to the members of the task force for consideration and potential revision of the guideline. The final CPG will be reviewed by the BOD, and if there are no further editorial or substantive changes, the document will be published in Audiology Today or other relevant Academy publication (e.g., Journal of the American Academy of Audiology) for archival purposes (See Appendix A).

The following outline represents a suggested structure for the creation of CPG. The purpose of the outline is to improve consistency across all Academy guidelines and to provide a common format for the task forces. The outline is not necessarily prescriptive, as applying a strict uniform methodology is somewhat problematic when developing CPG because they address such diverse conditions, procedures, and treatment interventions. The outline presented below is a compilation of current guideline formats of this and other professional associations, information obtained from the National Quality Measures Clearinghouse, the National Guideline Clearinghouse, and other sources (see “Related References” section at the end of this document).

All Academy CPG will be reviewed by the task force within one year of implementation (if the timeline for review is not specifically defined by the task force). At that time, a decision will be made to maintain the guideline as is or to make content and/or editorial changes to the entire guideline or specific areas within the guideline based on current practice standards. After the initial review, the task force will make a determination for a future review timeline (e.g., annually, every two years, or every three years) not to exceed five years for periodic review.

Clinical Practice Guidelines Format

I. Title Page

  1. Full title for condition, procedure, or treatment intervention
  2. Full names of authors (members of the task force)
  3. Describe how the writing group was selected (include a description of the credentials for each group member)
  4. Date of completion (release date)
  5. Print and electronic sources

II. Introduction

  1. Purpose/Focus of the guideline—the condition, disease, treatment, procedure, technology, etc. addressed in the guideline
  2. Goal—what is the guideline expected to achieve; describe need for the guideline
  3. Describe intended users and settings in which guideline will be used
  4. Describe intended target patient population

III. Methodology

  1. Describe the systematic methods used to search for evidence; include range of dates and databases searched (e.g., MEDLINE/PubMed; Cochrane Library, etc.); include the criteria for article inclusion
  2. Provide the criteria used to rate the quality and strength of evidence to support conclusions and recommendations (see Table 2).

Table 2. Level of Evidence Hierarchy for High-Quality Studies

Level Type of Evidence
1 Systematic reviews and meta-analyses of randomized controlled trials
2 Randomized controlled trials
3 Nonrandomized intervention studies
4 Nonintervention studies: cohort studies, case-control studies, cross-sectional surveys
5 Case reports
6 Expert opinion

System for Quality Rating of Individual Studies

Rating Interpretation of Rating
++ Very low risk of bias. Any weaknesses that are present are very unlikely to alter the conclusions of the study.
+ Low risk of bias. Identified weaknesses or omitted information probably would not alter the conclusions of the study.
__ High risk of bias. Identified weaknesses or omitted information are likely or very likely to alter the conclusions of the study.

Source: Adapted from Cox, 2005.

IV. Discussion/Results/Recommendations

  1. Provide and discuss the evidence that lead to the conclusions. Make recommendations that are specific and unambiguous.
    1. All recommendations will be written in complete sentences.
    2. Separate recommendations that apply to specific clinical objectives.
    3. Include information regarding areas of uncertainty or controversy in the recommendation as necessary.
    4. To the extent possible, quantify benefits, harms, and/or timeframes.
    5. Include flexibility in applying recommendations (e.g., special populations), where appropriate.
  2. Assign classification level to individual recommendations. (See Table 3).

Table 3. Classification of Recommendations

Class  
1 Conditions for which there is evidence and/or general agreement that a given procedure or treatment is useful and effective.
2 Conditions for which there is conflicting evidence and/or divergence of opinion about usefulness/efficacy of a specific procedure or treatment.
3 Conditions for which there is evidence and/or general agreement that the procedure/treatment is not useful and/or effective.

Source: Adapted from American Heart Association.

V. Conclusion/Summary

  1. Provide an overview of presented data.
  2. Highlight gaps in existing literature.
  3. Describe areas that need further study.
  4. Provide recommendations that will encourage research related to guideline topic area.
  5. Provide suggested timeline for review of guideline

VI. References (provide a comprehensive list of references and related readings)
Appendix A

Appendix A: Process Timetable


References
American Heart Association. AHA Statement and Guideline Development. http://www.americanheart.org/presenter.jhtml?identifier=3023366 (accessed
April 15, 2006).

Bakal CW. (2000) Quality improvement for diagnostic neuroangiography and other procedures. J Vasc Interv Radiol 11:1-3.

Cox RM. (2005) Evidence-based practice in provision of amplification. J Am Acad
Audiol 16(7):414-438.

Committee to Advise the Public Health Service on Clinical Practice Guidelines.
Institute of Medicine. (1990) Clinical Practice Guidelines. Washington, DC: National Academy Press.

Sackett DL, Rosenberg WM, Gray JA, Haynes RB, Richardson WS. (1996)
Evidence-based medicine: what it is and what it isn’t. BMJ 312(7023):71-72.

Related References
American College of Chest Physicians. ACCP Evidence-Based Guidelines. http://www.chestnet.org/education/guidelines (accessed April 15, 2006).

Agency for Healthcare Research and Quality. National Quality Measures Clearinghousehttp://www.qualitymeasures.ahrq.gov/ (accessed April 15,
2006).

Harbour R, Miller J. (2001) A new system for grading recommendations in
evidence based guidelines. BMJ 323:334-336. http://bmj.bmjjournals.com/cgi/content/full/323/7308/334?maxtoshow=&HITS=10&hits=10&RESULTFORMAT=&fulltext=guidelines&
andorexactfulltext=and&searchid=1137430157848_12629&FIRSTINDEX=
0&sortspec=relevance&volume=323&resourcetype=1
.

National Guideline Clearinghouse. Guideline Resources. http://www.guideline.gov/resources/guideline_resources.aspx (accessed
April 15, 2006).

Shekelle P, Eccles MP, Grimshaw JM, Woolf SH. (2001) When should clinical
guidelines be updated? BMJ 323:155-157. http://bmj.bmjjournals.com/cgi/content/full/323/7305/155#Fu2.

Shiffman RN, Shekelle P, Overhage JM, Slutsky J, Grimshaw J, Deshpande
AM. (2003) Standardized reporting of clinical practice guidelines: a proposal
from the conference on guidelines standardization. Ann Intern Med
139(6):493-498. http://www.annals.org/cgi/content/full/139/6.]

Yale Center for Medical Informatics. COGS: The Conference on Guideline
Standardization.[ditto italics as in ACCP reference above] Agency for
Healthcare Research and Quality. http://gem.med.yale.edu/cogs/statement.do.