Innovation and Tribulation in the History of Randomized Controlled Trials in Surgery

被引:7
|
作者
Bothwell, Laura E. [1 ]
Jones, David S. [2 ]
机构
[1] Worcester State Univ, Hlth Sci Dept, Worcester, MA 01602 USA
[2] Harvard Med Sch, Dept Global Hlth & Social Med, Boston, MA 02115 USA
关键词
blinding; history of surgery; randomized controlled trials; surgery; surgical research; MAMMARY-ARTERY LIGATION; SURGICAL INNOVATION; CLINICAL-TRIALS;
D O I
10.1097/SLA.0000000000003631
中图分类号
R61 [外科手术学];
学科分类号
摘要
Despite persistent critiques of the rigor of surgical research, surgeons have actually pursued careful empirical studies for centuries. Their work has enriched not only surgical science but also the development of evidence-based medicine. From conducting landmark controlled trials, to using statistics. alternate patient allocation, randomization, and sham controls, surgeons have long embraced innovative trial approaches and played important roles in the development of key methods of RCTs. However, historical contexts unique to surgery have shaped the implementation of RCTs in this field. Unlike the history of pharmaceuticals, in which substantial research funding has been devoted to testing new drugs before their approval, surgical trials have followed a different trajectory. New operations have repeatedly come into wide use in the absence of RCTs. On many occasions, when established procedures have become controversial, surgeons have then marshaled the resources to conduct RCTs reassessing the operations. Such trials have triggered powerful debates in which proponents of surgical RCTs battled against ingrained practices and preferences. In such cases, RCTs often were not decisive factors in determining the fate of surgical practices but supporting tools that followed and reflected changes in surgical judgment already underway. Surgical trialists also have encountered specific. recurring challenges. especially with the methodological and ethical complexity of blinded and sham-controlled trials. The history of surgical trials thus reveals major contributions from surgeons to the advancement of evidence-based medicine, as well as ongoing challenges. Strengthened and systematic trial support could advance the future of surgical RCTs.
引用
收藏
页码:E616 / E624
页数:9
相关论文
共 50 条
  • [31] RANDOMIZED CONTROLLED TRIALS OF CORONARY-ARTERY SURGERY
    KAYSER, KL
    AMERICAN HEART JOURNAL, 1972, 84 (04) : 580 - &
  • [32] Statistical Power of Randomized Controlled Trials in Trauma Surgery
    Berg, Arthur
    Lyons, Nicole B.
    Badami, Abbasali
    Reynolds, John
    Pizano, Louis
    Pust, Gerd Daniel
    Meizoso, Jonathan
    Namias, Nicholas
    Yeh, Daniel Dante
    JOURNAL OF THE AMERICAN COLLEGE OF SURGEONS, 2023, 237 (05) : 731 - 736
  • [33] RANDOMIZED CONTROLLED TRIALS IN GENERAL-SURGERY - REPLY
    MCLEOD, RS
    SOLOMON, MJ
    SURGERY, 1995, 117 (03) : 356 - 356
  • [34] Quality of Reporting for Randomized Controlled Trials in Craniofacial Surgery
    Borrelli, M. Roscali
    Farwan, R.
    Abukhder, M.
    Mobarak, D.
    Chicco, M.
    Thavayogan, R.
    Pidgeon, T. Edward
    Agha, R.
    BRITISH JOURNAL OF SURGERY, 2018, 105 : 107 - 107
  • [35] HISTORY OF CLINICAL TRIALS The Emergence of the Randomized, Controlled Trial
    Bothwell, Laura E.
    Podolsky, Scott H.
    NEW ENGLAND JOURNAL OF MEDICINE, 2016, 375 (06): : 501 - 504
  • [36] Development of a composite endpoint for randomized controlled trials in liver surgery
    van den Broek, M. A. J.
    van Dam, R. M.
    van Breukelen, G. J. P.
    Bemelmans, M. H.
    Oussoultzoglou, E.
    Pessaux, P.
    Dejong, C. H. C.
    Freemantle, N.
    Damink, S. W. M. Olde
    BRITISH JOURNAL OF SURGERY, 2011, 98 (08) : 1138 - 1145
  • [37] Randomized controlled trials and high-intensity spine surgery
    Schoenfeld, Andrew J.
    SPINE JOURNAL, 2020, 20 (10): : 1725 - 1727
  • [38] The Statistical Fragility of Foot and Ankle Surgery Randomized Controlled Trials
    Milto, Anthony J.
    Negri, Cecily E.
    Baker, Jeffrey
    Thuppal, Sowmyanarayanan
    JOURNAL OF FOOT & ANKLE SURGERY, 2023, 62 (01): : 191 - 196
  • [39] Standards of Reporting of Randomized Controlled Trials in General Surgery Reply
    Nevar, Pamela M.
    Rikkers, Layton F.
    Lillemoe, Keith D.
    ANNALS OF SURGERY, 2008, 248 (06) : 1107 - 1108
  • [40] Diversity Challenges and Opportunities for Randomized Controlled Trials in Cardiothoracic Surgery
    Takkenberg, Johanna J. M.
    ANNALS OF THORACIC SURGERY, 2022, 113 (05): : 1418 - 1419