CAN CONTRAINDICATIONS COMPROMISE EVIDENCE-BASED, PATIENT- CENTERED CLINICAL PRACTICE?

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Victor M Montori
Teresa W Leung
Teresa W Leung
PJ Devereaux
Holger J Schünemann
Elie A Akl
Amiram Gafni
Gordon H Guyatt

Keywords

Drug, label, contraindications, decision-making, evidence-based medicine

Abstract

Background


Despite their often weak evidence base, contraindications convey the unequivocally adverse risk-benefit profile of an intervention in a specific clinical context. However, some patients in that context may nonetheless prefer the contraindicated intervention (with its potential benefits and risks) to the available alternatives. The impact of contraindications on treatment decisions remains unexplored.


 Objective


To provide an estimate of the impact of the “contraindication” label on treatment decisions.


 Methods


We conducted an international 6-wave email/internet and fax survey of practicing clinicians who were members of the American Diabetes Association or the College of Physicians and Surgeons of Ontario and had available email addresses and fax numbers. Each participant considered one of two patient scenarios. In  each scenario, the  patient  expressed a  strong preference for  use  of  a  medication that  carried a “contraindication” label despite weak evidence of harm. We designed these scenarios so that respondents who placed greater weight on patient preferences and research evidence than on the label “contraindication” would  be  ready  to  prescribe the  contraindicated medication.  We  determined the frequency with which the label “contraindication” dominated participants’ treatment decisions despite patient preferences and weak evidence of harm.


 Results


466 participants responded (22% response rate). Depending on the group and scenario, contraindications dominated the decisions of 47% to 89% of surveyed clinicians, superseding patient preferences and research evidence.


 Conclusions


The label “contraindication” may often dominate clinicians’ decisions about treatment and may compromise evidence-based, patient-centered clinical  practice. Further research should elucidate  the process that leads to the formulation of contraindications and its impact on treatment decision-making.


 

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References

1. . Haynes RB, Devereaux PJ, Guyatt GH. Physicians' and patients' choices in evidence based practice. BMJ. Jun 8 2002;324(7350):1350.
2. Jones GC, Macklin JP, Alexander WD. Contraindications to the use of metformin. BMJ. Jan 4 2003;326(7379):4-5.
3. Misbin RI. The Phantom of Lactic Acidosis due to Metformin in Patients With Diabetes. Diabetes Care. Jul 2004;27(7):1791-1793.
4. Dodick D, Lipton RB, Martin V, et al. Consensus Statement: Cardiovascular Safety Profile of Triptans (5-HT1B/1D Agonists) in the Acute Treatment of Migraine. Headache. May 01, 2004 2004;44(5):414-425.
5. Dillman D. Mail and Internet Surveys: The Tailored Design Method. New York, NY: John Wiley & Sons; 2000.
6. Montori VM, Leung TW, Walter SD, Guyatt GH. Procedures that assess inconsistency in meta- analyses can assess the likelihood of response bias in multiwave surveys. J Clin Epidemiol.2005 Aug;58(8):856-8.
7. Drane JW. Imputing nonresponses to mail-back questionnaires. Am J Epidemiol. Oct 15 1991;134(8):908-912.
8. Grandjean P. Implications of the precautionary principle for primary prevention and research. Annu Rev Public Health. 2004;25:199-223.
9. Levine MN, Gafni A, Markham B, MacFarlane D. A bedside decision instrument to elicit a patient's preference concerning adjuvant chemotherapy for breast cancer. Ann Intern Med. Jul 1 1992;117(1):53-58.
10. Whelan T, Levine M, Willan A, et al. Effect of a decision aid on knowledge and treatment decision making for breast cancer surgery: a randomized trial. JAMA. Jul 28 2004;292(4):435-441.