The relation between methods and recommendations in clinical practice guidelines for hypertension and hyperlipidemia

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Original Research

The relation between methods and recommendations in clinical practice guidelines for hypertension and hyperlipidemia

J Fam Pract. 2002 November;51(11):963-968

By

Atle Fretheim, MD

OBJECTIVE: To assess the association between methods used to develop clinical practice guidelines and the recommendations that are made.
STUDY DESIGN: Systematic review of clinical practice guidelines for hypertension or hyperlipidemia.
OUTCOMES MEASURED: Two people independently appraised guideline methods by using 8 criteria and the aggressiveness of recommendations for treatment thresholds, initial drug selection, and screening.
RESULTS: We identified 33 guidelines. Only 6 fulfilled 5 or more of the 8 criteria. For 5 of the criteria, fewer than 50% of the guidelines fulfilled those criteria. There was wide variation in recommendations for treatment thresholds, drug selection, and cholesterol screening. Guidelines that did not fulfill the criteria tended to suggest more aggressive recommendations than did guidelines that met the criteria. For 6 of the 8 criteria, guidelines published by specialty societies were less likely to fulfill them compared with guidelines not published by specialty societies.
CONCLUSIONS: Guideline developers who did not use rigorous methods tended to promote intervening more aggressively for hypertension and hyperlipidemia.

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References

1. Miller J, Petrie J. Development of practice guidelines. Lancet 2000;355:82-3.

2. Eddy D. A Manual for Assessing Health Practices and Designing Practice Policies: The Explicit Approach. Philadelphia: American College of Physicians; 1992.

3. Scottish Intercollegiate Guidelines Network. An Introduction to SIGN Methodology for the Development of Evidence-Based Clinical Guidelines. Vol 39. Edinburgh: Scottish Intercollegiate Guidelines Network; 1999.

4. Shekelle PG, Woolf SH, Eccles M, Grimshaw J. Clinical guidelines: developing guidelines. BMJ 1999;318:593-6.

5. Guidelines for Clinical Practice. From Development to Use. Washington, DC: National Academy Press; 1992.

6. Canadian Medical Association. Quality of Care Program: The Guidelines for Canadian Clinical Practice. Ottawa: Canadian Medical Association; 1993.

7. Guideline Advisory Committee. Recommended clinical practice guidelines. Available at: http://www.gacguidelines.ca/ aboutGAC. html. Accessed April 4, 2002.

8. Gibson P. Asthma guidelines and evidence-based medicine. Lancet 1993;342:1305.-

9. Savoie I, Kazanjian A, Bassett K. Do clinical practice guidelines reflect research evidence? J Health Serv Res Policy 2000;5:76-82.

10. Grilli R, Magrini N, Penna A, Mura G, Liberati A. Practice guidelines developed by specialty societies: the need for a critical appraisal. Lancet 2000;355:103-6.

11. Shaneyfelt TM, Mayo-Smith MF, Rothwangl J. Are guidelines following guidelines? The methodological quality of clinical practice guidelines in the peer-reviewed medical literature. JAMA 1999;281:1900-5.

12. St George’s Hospital Medical School Health Care Evaluation Unit. Appraisal of guidelines research & evaluation. Available at: http://www.sghms.ac.uk/depts/phs/hceu/biomed.htm. Accessed December 12, 2000.

13. Cluzeau FA, Littlejohns P, Grimshaw J, Feder G. Appraisal Instrument for Clinical Guidelines. London: St George’s Hospital Medical School; 1997.

14. Graham ID, Calder LA, Hébert PC, Carter AO, Tetroe JM. A comparison of clinical practice guideline appraisal instruments. Int J Technol Assess Health Care 2000;16:1024-38.

15. Herrin J, Etchason JA, Kahan JP, Brook RH, Ballard DJ. Effect of panel composition on physician ratings of appropriateness of abdominal aortic aneurysm surgery: elucidating differences between multispecialty panel results and specialty society recommendations. Health Policy 1997;42:67-81.

16. Coulter I, Adams A, Shekelle P. Impact of varying panel membership on ratings of appropriateness in consensus panels: a comparison of a multi- and single disciplinary panel. Health Serv Res 1995;30:577-91.

17. Murphy MK, Black NA, Lamping DL, et al. Consensus development methods, and their use in clinical guideline development. Health Technol Assess 1998;2(3):i-iv,1-88.

KEY POINTS FOR CLINICIANS

Many guidelines address the same problems, often with conflicting recommendations.
There is considerable variation regarding the methods the guideline developers use to make recommendations.
Guideline developers who did not use rigorous methods appeared to make more aggressive recommendations for screening and treatment (ie, were more likely to promote interventions).

Clinicians are inundated with clinical practice guidelines. Many guidelines address the same problems, often with conflicting recommendations. The disagreement concerning recommendations often hinges on how aggressive clinicians are in promoting interventions, eg, screening for prostate cancer or prescribe antibiotics for the treatment of sore throat. There is also variation with regard to the methods that guideline developers use to make recommendations. The traditional “GOBSAT”-technique (“Good Old Boys Sat At Table”) has been criticized.¹ Several groups have proposed more systematic approaches for guideline development,^2-6 and some databases, such as the Guideline Advisory Committee’s Recommended Clinical Practice Guidelines, include only those guidelines that have been assessed for the rigor of the development process.⁷

There are strong logical arguments for developing guidelines systematically, eg, to ensure that they are based on current best evidence, to protect against bias, and to make the process transparent and open to criticism. However, guideline developers frequently do not adhere to such methods.^8-11 We explored the possible association between the methods used in guideline development and the recommendations given in those guidelines. We used guidelines for hypertension and hyperlipidemia in our study. Our hypothesis was that less rigorous methods would, on average, be associated with more aggressive recommendations in these guidelines.

Methods

Inclusion criteria

We defined clinical guidelines as recommendations intended to assist health professionals and patients in making decisions for specific clinical circumstances. To be included a guideline had to address at least 1 of the following issues: threshold for drug treatment of essential hypertension in primary prevention, threshold for drug treatment of hyperlipidemia in primary prevention, or identification of the target population for cholesterol screening. Guidelines were excluded if they did not clearly identify the panel responsible for developing the guideline, identify a sponsoring organization, or include a reference list. We excluded textbooks, editorials, and commentaries. Review articles that were prepared and published as background documents were included with the relevant clinical practice guidelines. We included guidelines published after 1992. When multiple versions were available from the same organization, we used the most recent version.

Search strategy

We searched MEDLINE from 1992 through February 2000 by using hypertension, blood pressure, hyperlipidemia, or cholesterol as the key term, limited to practice guidelines as publication type. In addition, we searched databases of guidelines maintained by several groups around the world. One author (A.F.) reviewed all the citations and reference lists of relevant guidelines, retrieved potentially relevant guidelines, and selected guidelines for inclusion.

Guideline development methods

We used 8 criteria to rate the methodologic quality of the guidelines (Table 1). The criteria were adapted from a guideline appraisal instrument that is being developed and tested by a group of European researchers (the Agree/Biomed collaboration).¹² It is based on a British Appraisal Instrument for Clinical Guidelines ¹³ that has been tested for its validity and reliability and has been characterized as “the most well developed to date” in a recent study.¹⁴

Two authors (A.F. and J.W.W.) evaluated each guideline independently. For analytical purposes, all criteria were dichotomized (Table 1). Because fewer than 50% of the guidelines reported sufficient information to determine stakeholder involvement, we supplemented information on authors through an Internet search.

TABLE 1

Criteria used to appraise guideline-development methods

Criterion	Standard for fulfillment
Main outcomes identified
Is there an explicit statement of the main outcomes considered when developing the guideline?	Explicit statement of the main outcomes considered in developing the guidelines
Key stakeholders involved
Are the essential stakeholders involved in the development group?	Inclusion of all “essential” stakeholders (generalist physicians, specialists, and methodologists)*
Systematic search and selection
Has a systematic search for evidence been carried out and are criteria for inclusion and exclusion specified?	Search specifying all relevant databases or described “electronic databases” or
	Inclusion–exclusion criteria defined, at least briefly
Recommendations linked to evidence
Is there an explicit link between the evidence and the recommendations given?	Grading of strength of recommendations or level of evidence
Benefits and risks considered
Have the health benefits, side effects, and risks been considered?	Any quantitative or qualitative weighing of benefits and harms that is incorporated into formulating recommendations
Resources/costs
Has the impact on resources been considered?	Economic analysis or qualitative consideration of cost issues that is linked explicitly to the formulation of the recommendations
No industry influence
Is the guideline developed without funding or influence from the pharmaceutical industry?	No financial support from a pharmaceutical company and no involvement on the panel
Conflicts of interest stated
Is there an explicit statement of conflict of interest?	Statement of potential conflicts of interest for panel members
*Essential stakeholders are generalist physicians, specialists, and methodologists. Optional stakeholders are patients, policy makers/health administrators, nurses, pharmacists, economists, and other physicians.