Representation of Samples in Clinical Trials of Hypertension Medications_Chinese Journal of Evidence-Based Medicine

Authors：

HU Jing ,  KANG Deying

Department of Evidence-Based Medicine and Clinical Epidemiology, West China Hospital, Sichuan University, Chengdu 610041, China;

Corresponding author：

KANG Deying, Email: deyingkang@126.com

Keywords：

Hypertension; Clinical trial; Representation of samples

DOI：

10.7507/1672-2531.20080043

Video：

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Objective　 To explore and appraise the representation of samples in clinical trials of hypertension medications.
Methods　 Four databases (MEDLINE, CBM, CNKI and VIP )were searched systematically. All RCTs of hypertension medication run in China from January 1996 to December 2006 were collected, and then appraised by a quality assessment checklist. Those RCTs with 3 or more grading score were enrolled for critical appraisal of representation of samples.
Results　 A total of 164 RCTs on hypertension were targeted and reviewed systematically. 122 (74.4%) RCTs selected secondary or tertiary cares as their trial settings. 81 (49.4%) RCTs described the source of samples, in which 86.3% were hospitalized patients. 16.7% patients in 12 (7.3%) RCTs were excluded in run-in periods, 24.6% patients were ineligible for inclusion criteria in 8 (4.9%) RCTs. 8.4% eligible patients were non-enrolled in 3 RCTs. 89.4% subjects were mild to moderate essential hypertension. The proportions of women and the patients aged 65 years or older were 41.1% and 16.9%, respectively, and were markedly lower than that in community (P lt;0.001).
Conclusion　 Representation of samples in clinical trials of hypertension medications was not good and the influencing factors of representation were not reported sufficiently. These would undermine the efforts to provide evidence-based care to all hypertensive patients.

Citation： HU Jing,KANG Deying. Representation of Samples in Clinical Trials of Hypertension Medications. Chinese Journal of Evidence-Based Medicine, 2008, 08(3): 199-202. doi: 10.7507/1672-2531.20080043 Copy

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1. Rothwell PM. External validity of randomised controlled trials: "to whom do the results of this trial apply?". Lancet, 2005, 365(9453): 82-93.
2. Gross CP, Mallory R, Heiat A, et al. Reporting the recruitment process in clinical trials: who are these patients and how did they get there? Ann Intern Med, 2002, 137(1): 10-16.
3. Persaud N, Mamdani MM. External validity: the neglected dimension in evidence ranking. J Eval Clin Pract, 2006, 12(4): 450-453.
4. Steg PG, López-Sendón J, Lopez de Sa E, et al. External validity of clinical trials in acute myocardial infarction. Arch Intern Med, 2007, 167(1): 68-73.
5. 卫生部心血管病防治研究中心. 中国心血管病报告2005. 北京: 中国大百科全书出版社, 2006. 84-94.
6. Britton A, McKee M, Black N, et al. Threats to applicability of randomised trials: exclusions and selective participation. J Health Serv Res Policy, 1999, 4(2):112-121.
7. Roberts C. The implications of variation in outcome between health professionals for the design and analysis of randomized controlled trials. Stat Med, 1999, 18(19): 2605-2615.
8. Petersen MK, Andersen KV, Andersen NT, et al. "To whom do the results of this trial apply?" External validity of a randomized controlled trial involving 130 patients scheduled for primary total hip replacement. Acta Orthop, 2007, 78(1): 12-18.
9. Packer M, Bristow MR, Cohn JN, et al. The effect of carvedilol on morbidity and mortality in patients with chronic heart failure. U.S. Carvedilol Heart Failure Study Group. N Engl J Med, 1996, 334(21): 1349-1355.
10. Uijen AA, Bakx JC, Mokkink HG, et al. Hypertension patients participating in trials differ in many aspects from patients treated in general practices. J Clin Epidemiol, 2007, 60(4): 330-335.
11. Coca SG, Krumholz HM, Garg AX, et al. Under-representation of renal disease in randomized controlled trials of cardiovascular disease. JAMA, 2006, 296(11): 1377-1384.

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