Orthopaedic surgeons prefer to participate in expertise-based randomized trials

Orthopaedic surgeons prefer to participate in expertise-based randomized trials
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DOI:
10.1007/s11999-008-0273-9
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发表时间:
2008-07-01
影响因子:
4.2
通讯作者:
Devereaux, P. J.
Devereaux, P. J.
中科院分区:
医学2区
文献类型:
--
作者:
Bednarska, Elzbieta;Bryant, Dianne;Devereaux, P. J.

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经验数据和理论论证表明,一种替代的随机临床试验(RCT)设计,称为基于专家的RCT,与传统的RCT相比,具有更高的有效性,适用性和伦理完整性。然而,关于医生是否会参加基于专业知识的随机对照试验,我们知之甚少。在一项对加拿大骨科医生的横断面调查中,如果有机会参加一项研究胫骨高位截骨术与单髁膝关节置换术的有效性的试验,我们评估了参与基于专业知识的RCT与传统RCT的偏好和意愿。使用电子调查((c)2005 SurveyMonkey.com),我们邀请了加拿大骨科协会(2005年)的所有767名成员参加; 276名外科医生完成了问卷(37.5%的回复率)。102名外科医生(53.4%)愿意参加基于专业知识的RCT,而35名外科医生(18.3%)愿意参加传统RCT。97名外科医生(52.4%)强烈或中度偏好基于专业知识的设计,而25名(13.5%)偏好传统设计。对于我们提出的临床示例,大多数加拿大骨科医生愿意参与并更喜欢基于专业知识的设计。基于专业知识的随机临床试验设计可能会克服骨科临床试验的一些障碍,并提高其结论的有效性。
Empiric data and theoretical arguments suggest an alternative randomized clinical trial (RCT) design, called expertise-based RCT, has enhanced validity, applicability, and ethical integrity compared with conventional RCT. Little is known, however, about whether physicians will participate in an expertise-based RCT. In a cross-sectional survey of Canadian orthopaedic surgeons, we evaluated preference for and willingness to participate in an expertise-based versus a conventional RCT if given the opportunity to participate in a trial investigating the effectiveness of high tibial osteotomy versus unicompartmental knee arthroplasty. Using an electronic survey ((c) 2005 SurveyMonkey.com), we invited all 767 members of the Canadian Orthopaedic Association (2005) to participate; 276 surgeons completed the questionnaire (37.5% response rate). One hundred two surgeons (53.4%) were willing to participate in an expertise-based RCT compared with 35 surgeons (18.3%) willing to participate in a conventional RCT. Ninety-seven surgeons (52.4%) strongly or moderately preferred the expertise-based design compared with 25 (13.5%) who preferred the conventional design. For the clinical example we presented, the majority of Canadian orthopaedic surgeons were willing to participate in and preferred the expertise-based design. The expertise-based randomized clinical trial design may overcome some of the barriers to conducting clinical trials in orthopaedic surgery and improve the validity of their conclusions.