A guide to planning and executing a surgical randomized controlled trial

被引:13
作者
Chung, Kevin C. [1 ]
Burns, Patricia B. [1 ]
机构
[1] Univ Michigan Hlth Syst, Dept Surg, Sect Plast Surg, Ann Arbor, MI 48109 USA
来源
JOURNAL OF HAND SURGERY-AMERICAN VOLUME | 2008年 / 33A卷 / 03期
关键词
clinical trials; guide; surgery;
D O I
10.1016/j.jhsa.2007.11.027
中图分类号
R826.8 [整形外科学]; R782.2 [口腔颌面部整形外科学]; R726.2 [小儿整形外科学]; R62 [整形外科学(修复外科学)];
学科分类号
摘要
Evidence-based medicine requires that treatments given to patients demonstrate effectiveness. The randomized controlled trial (RCT) has become the preeminent study design to assess the efficacy of treatments. Randomized controlled trials are frequently used to evaluate pharmaceutical treatments but are less often used in surgery. The lack of surgical RCTs is partly due to ethical and methodological concerns associated with surgical interventions. We provide a guide to planning and conducting a surgical RCT.
引用
收藏
页码:407 / 412
页数:6
相关论文
共 34 条
[1]   Understanding randomised controlled trials [J].
Akobeng, AK .
ARCHIVES OF DISEASE IN CHILDHOOD, 2005, 90 (08) :840-844
[2]   Prospective comparative clinical trials in The Journal of Hand Surgery (American) [J].
Amadio, PC ;
Higgs, P ;
Keith, M .
JOURNAL OF HAND SURGERY-AMERICAN VOLUME, 1996, 21A (05) :925-929
[3]   Improving the quality of reporting of randomized controlled trials - The CONSORT statement [J].
Begg, C ;
Cho, M ;
Eastwood, S ;
Horton, R ;
Moher, D ;
Olkin, I ;
Pitkin, R ;
Rennie, D ;
Schulz, KF ;
Simel, D ;
Stroup, DF .
JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION, 1996, 276 (08) :637-639
[4]   Planning of clinical trials [J].
Boissel, JP .
JOURNAL OF INTERNAL MEDICINE, 2004, 255 (04) :427-438
[5]   A checklist to evaluate a report of a nonpharmacological trial (CLEAR NPT) was developed using consensus [J].
Boutron, I ;
Moher, D ;
Tugwell, P ;
Giraudeau, B ;
Poiraudeau, S ;
Nizard, R ;
Ravaud, P .
JOURNAL OF CLINICAL EPIDEMIOLOGY, 2005, 58 (12) :1233-1240
[6]   The design and assessment of prospective randomised, controlled trials in orthopaedic surgery [J].
Boutron, I. ;
Ravaud, P. ;
Nizard, R. .
JOURNAL OF BONE AND JOINT SURGERY-BRITISH VOLUME, 2007, 89B (07) :858-863
[7]  
CARTER R, 2004, BMC MED RES METHODOL, V255, P427
[8]   Commentary: The quality of reporting and outcome measures in randomized clinical trials related to upper-extremity disorders [J].
Chung, KC .
JOURNAL OF HAND SURGERY-AMERICAN VOLUME, 2004, 29A (04) :735-737
[9]   Commentary - Outcomes of carpal tunnel surgery with and without supervised postoperative therapy [J].
Chung, Kevin C. .
JOURNAL OF HAND SURGERY-AMERICAN VOLUME, 2007, 32A (08) :1164-1165
[10]   Outcomes research in hand surgery: Where have we been and where should we go? [J].
Chung, Kevin C. ;
Burns, Patricia B. ;
Sears, Erika Davis .
JOURNAL OF HAND SURGERY-AMERICAN VOLUME, 2006, 31A (08) :1373-1379