Improving depiction of benefits and harms: Analyses of studies of well-known therapeutics and review of high-impact medical journals

Medical Care

Volumn 45, Issue 10 SUPPL. 2, 2007, Pages

  Sedrakyan, Artyom ^a,b,c   Shih, Chuck ^a  

^a AGENCY FOR HEALTHCARE RESEARCH AND QUALITY   (United States)

^b LONDON SCHOOL OF HYGIENE AND TROPICAL MEDICINE   (United Kingdom)

^c YALE UNIVERSITY SCHOOL OF MEDICINE   (United States)

Author keywords

Benefits and harms; Informed choice; Patient education; Risk communication; Systematic review

Indexed keywords

ACETYLSALICYLIC ACID; ACETYLSALICYLIC ACID PLUS DIPYRIDAMOLE; ANOREXIGENIC AGENT; DIPYRIDAMOLE; FIBRINOLYTIC AGENT; NEUROLEPTIC AGENT; ORAL CONTRACEPTIVE AGENT; PHENYLPROPANOLAMINE; TISSUE PLASMINOGEN ACTIVATOR;

CHEMICALLY INDUCED DISORDER; CONFERENCE PAPER; DECISION MAKING; DRUG COMBINATION; DRUG SCREENING; EVIDENCE BASED MEDICINE; HORMONE SUBSTITUTION; HUMAN; INFORMATION DISSEMINATION; LITERATURE; PHARMACOEPIDEMIOLOGY; RISK ASSESSMENT; STROKE;

ANTIPSYCHOTIC AGENTS; APPETITE DEPRESSANTS; ASPIRIN; CONTRACEPTIVES, ORAL; DECISION MAKING; DIPYRIDAMOLE; DRUG COMBINATIONS; DRUG EVALUATION; EVIDENCE-BASED MEDICINE; FIBRINOLYTIC AGENTS; HORMONE REPLACEMENT THERAPY; HUMANS; INFORMATION DISSEMINATION; PHARMACOEPIDEMIOLOGY; PHENYLPROPANOLAMINE; REVIEW LITERATURE AS TOPIC; RISK ASSESSMENT; STROKE; TISSUE PLASMINOGEN ACTIVATOR;

EID: 34848870609     PISSN: 00257079     EISSN: 15371948     Source Type: Journal    
DOI: 10.1097/mlr.0b013e3180642f69     Document Type: Article

References (29)

1. IOM. Forum on Drug Discovery, Development, and Translation Workshop 2: Understanding the Benefits and Risks of Pharmaceuticals. 2006. Available at: http://www.iom.edu/CMS/3740/24155/32576.aspx. Accessed November 22, 2006.
2. McNutt RA. Shared medical decision making: problems, process, progress. JAMA. 2004;292:2516-2518.
3. Laupacis A, Sackett DL, Roberts RS. An assessment of clinically useful measures of the consequences of treatment. N Engl J Med. 1988;318:1728-1733.
4. Cook RJ, Sackett DL. The number needed to treat: a clinically useful measure of treatment effect. BMJ. 1995;310:452-454.
5. Halvorsen PA, Kristiansen IS. Decisions on drug therapies by numbers needed to treat: a randomized trial. Arch Intern Med. 2005;165:1140-1146.
6. Sheridan SL, Pignone MP, Lewis CL. A randomized comparison of patients' understanding of number needed to treat and other common risk reduction formats. J Gen Intern Med. 2003;18:884-892.
7. Elmore JG, Gigerenzer G. Benign breast disease - the risks of communicating risk [comments]. N Engl J Med. 2005;353:1856-1858.
8. Gigerenzer G, Edwards A. Simple tools for understanding risks: from innumeracy to insight. BMJ. 2003;327:741-744.
9. Gigerenzer G. Reckoning With Risk. 1st ed. London, England: Penguin Books; 2002.
10. ARHP. A.O.R.H.P. Tools for Communicating Risk About Hormonal Contraceptives. 2007. Available at: http://www.arhp.org/healthcareproviders/cme/ onlinecme/RiskProjectCP/tools.cfm. Accessed March 16, 2007.
11. Farley TM, Collins J, Schlesselman JJ. Hormonal contraception and risk of cardiovascular disease. An international perspective. Contraception. 1998;57:211-230.
12. Gillum LA, Mamidipudi SK, Johnston SC. Ischemic stroke risk with oral contraceptives: a meta-analysis. JAMA. 2000;284:72-78.
13. FHI. F.H.I. What Are the Benefits and Risks of Combined Oral Contraceptives? Reproductive Health Fact Sheet 2006. Available at: http://www.fhi.org/en/RH/Pubs/factsheets/ocriskben.htm. Accessed October 27, 2006.
14. Jick H, Aselton P, Hunter JR. Phenylpropanolamine and cerebral haemorrhage. Lancet. 1984;1:1017.
15. Kernan WN, Viscoli CM, Brass LM, et al. Phenylpropanolamine and the risk of hemorrhagic stroke. N Engl J Med. 2000;343:1826-1832.
16. Phenylpropanolamine. 2006. Available at: http://en.wikipedia.org/wiki/ Phenylpropanolamine#-note-2. Accessed October 27, 2006.
17. Dabela A. Yale Study Parks FDA Review of Cold Drugs. The Yale Herald News Online 2000. Available from http://www.yaleherald.com/archive/xxx/2000.10.27/ news/index.html. Accessed October 27, 2006.
18. The Women's Health Initiative Study Group. Design of the Women's Health Initiative clinical trial and observational study. Control Clin Trials. 1998;19:61-109.
19. Rossouw JE, Anderson GL, Prentice RL, et al. Risks and benefits of estrogen plus progestin in healthy postmenopausal women: principal results from the women's health initiative randomized controlled trial. JAMA. 2002;288:321-333.
20. Bath PM, Gray LJ. Association between hormone replacement therapy and subsequent stroke: a meta-analysis [review]. BMJ. 2005.330:342.
21. Lee PE, Gill SS, Freedman M, et al. Atypical antipsychotic drugs in the treatment of behavioural and psychological symptoms of dementia: systematic review. BMJ. 2004;329:75.
22. Brodaty H, Ames D, Snowdon J, et al. A randomized placebo-controlled trial of risperidone for the treatment of aggression, agitation, and psychosis of dementia. J Clin Psychiatry. 2003;64:134-143.
23. Hacke W, Donnan G, Fieschi C, et al. Association of outcome with early stroke treatment: pooled analysis of ATLANTIS, ECASS, and NINDS rt-PA stroke trials. Lancet. 2004;363:768-774.
24. Diener HC, Cunha L, Forbes C, et al. European stroke prevention study, part 2: dipyridamole and acetylsalicylic acid in the secondary prevention of stroke. J Neurol Sci. 1996;143(1-2):1-13.
25. FDA. FDA Approves New Drug to Reduce Risk of Stroke. 1999. Available at: http://www.fda.gov/bbs/topics/ANSWERS/ANs00985.html. Accessed October 27, 2006.
26. Greendale GA, Reboussin BA, Hogan P, et al. Symptom relief and side effects of postmenopausal hormones: results from the postmenopausal estrogen/progestin interventions trial. Obstet Gynecol. 1998;92:982-988.
27. Nikolajevic-Sarunac J, Henry DA, O'Connell DL, et al. Effects of information framing on the intentions of family physicians to prescribe long-term hormone replacement therapy. J Gen Intern Med. 1999;14:591-598.
28. Collaborative Group on Hormonal Factors in Breast Cancer. Breast cancer and hormone replacement therapy: collaborative reanalysis of data from 51 epidemiological studies of 52,705 women with breast cancer and 108,411 women without breast cancer. Lancet 1997;350:1047-1059.
29. Naylor CD, Chen E, Strauss B. Measured enthusiasm: does the method of reporting trial results alter perceptions of therapeutic effectiveness? Ann Intern Med. 1992;117:916-921.