Guideline Development at the American College of Physicians. American College of Physicians

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1 Guideline Development at the American College of Physicians Melissa Starkey, PhD American College of Physicians Institute of Medicine Committee on Preventive Services for Women March 9, 2011

2 Who is ACP? The world s s largest medical specialty organization 130,000 members Internists Internal Medicine sub-specialists specialists Residents/fellows training in Internal Medicine or its subspecialties Medical students Headquarters in Philadelphia and an office in Washington, D.C.

3 History of Evidence-Based Guidelines at ACP Program was established in 1981 Early ACP guidelines addressed diagnostic tests and technologies Current guidelines address screening, diagnosis, and treatment

4 Three ACP Products 1. Clinical Guidelines Recommendations based on a review of available evidence 2. Guidance Statements Recommendations based on a review of existing guidelines 3. Best Practice Advice Advice for clinicians to provide high-value, cost- conscious care

5 Overview of ACP s s Guideline Development Process 1. Topic selection 2. Evidence review Background evidence-review paper 3. Guideline paper Guidelines Committee/Panel meetings and conference calls Internal review and approval 4. Submission to journal External peer-review review 5. Publication

6 How are Guideline Topics Selected? Prevalence Impact on mortality and morbidity Effective health care available Areas of uncertainty & evidence that current performance is deficient Cost Likelihood of availability of strong evidence Relevance to internal medicine

7 Evidence Review for Clinical Guidelines Evidence reviews can be: 1. Nominated to AHRQ s s Evidence-based Practice Centers 2. Sponsored by ACP 3. Collaboration with other societies Background evidence review paper published as a companion paper to guideline

8 Writing ACP s Guidelines ACP s Clinical Guidelines Committee (CGC) Consists of 12 physicians that meet 3 times/year and hold monthly conference calls Guidelines and recommendations written by CGC subpanel and ACP staff Recommendations voted on by CGC Guidelines approved by Board of Regents

9 Guideline Development Process Guidelines are strictly evidence-based No consensus statements Recommendations are based on evaluation/quantification of magnitude of benefits, harms, costs Conflicts of interest are disclosed and resolved prior to development Financial support for guideline development comes from ACP s operating budget Shelf life of ACP s s Guidelines = 5 years Currently working on formal update process

10 ACP s s Guideline Grading System Quality of Evidence Benefits clearly outweigh risks and burden OR risks and burden clearly outweigh benefits Strength of Recommendation Benefits finely balanced with risks and burden High Strong Weak Moderate Strong Weak Low Strong Weak Insufficient evidence to determine net benefits or risks I-recommendation * Adopted from the classification developed by the Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) workgroup.

11 Interpretation of ACP s s Grading System Grade of recommendation Benefit versus risks and burdens Methodological quality of supporting evidence Implications Strong recommendation, High quality evidence Strong recommendation, Moderate quality evidence Strong recommendation, Low quality evidence Benefits clearly outweigh risks and burden, or vice versa Benefits clearly outweigh risks and burden, or vice versa Benefits clearly outweigh risks and burden, or vice versa RCTs without important limitations or overwhelming evidence from observational studies RCTs with important limitations (inconsistent results, methodological flaws, indirect, or imprecise) or exceptionally strong evidence from observational studies Observational studies or case series Strong recommendation, can apply to most patients in most circumstances without reservation Strong recommendation but may change when higher quality evidence becomes available

12 Grade of recommendation Benefit versus risks and burdens Methodological quality of supporting evidence Implications Weak recommendation, High quality evidence Weak recommendation, Moderate quality evidence Benefits closely balanced with risks and burden Benefits closely balanced with risks and burden RCTs without important limitations or overwhelming evidence from observational studies RCTs with important limitations (inconsistent results, methodological flaws, indirect, or imprecise) or exceptionally strong evidence from observational studies Weak recommendation, best action may differ depending on circumstances or patients or societal values Weak recommendation, Low quality evidence Uncertainty in the estimates of benefits, risks, and burden; benefits, risks and burden may be closely balanced Observational studies or case series Very weak recommendations; other alternatives may be equally reasonable Insufficient Balance of benefits and risks cannot be determined Evidence is conflicting, poor quality, or lacking Insufficient evidence to recommend for or against routinely providing the service

13 Publication and Dissemination Submission to Annals of Internal Medicine Independent peer-review review process Published with companion background evidence review Dissemination Publically available Part of National Guideline Clearinghouse and Guidelines International Network

14 Three ACP Products 1. Clinical Guidelines Recommendations based on a review of available evidence 2. Guidance Statements Recommendations based on a review of available guidelines 3. Best Practice Advice Advice for clinicians to provide high-value, cost- conscious care

15 Process for Developing ACP s Guidance Statements 1. Identify relevant guidelines NGC search 2. Rate the quality of the guidelines AGREE instrument 3. Summarize guidelines and make recommendations

16 Process for Developing ACP s s Best Practice Advice 1. Identify medical topic with common misuse or overuse of intervention 2. Commission authors who are experts in the field 3. Discuss relevant literature 4. Formulate advice for physicians to reduce waste and provide high-value care

17 Relevant Active ACP Guidelines for Women Screening Mammography for Women 40 to 49 Years of Age: A Clinical Practice Guideline from the American College of Physicians (2007) Pharmacologic Treatment of Low Bone Density or Osteoporosis to Prevent Fractures: A Clinical Practice Guideline from the American College of Physicians (2008) Screening for HIV in Health Care Settings: A Guidance Statement From the American College of Physicians and HIV Medicine Association (2009)

18 Questions or suggestions for future guideline topics?