Need for expertise based randomised controlled trials

Devereaux, P.J.; Bhandari, Mohit; Clarke, Mike; Montori, Víctor M.; Cook, Deborah J.; Yusuf, Salim; Sackett, David L.; Cinà, Claudio S.; Walter, Stephen D.; Haynes, Brian; Schünemann, Holger J.; Norman, Geoffrey R.; Guyatt, Gordon

doi:10.1136/bmj.330.7482.88

Cited by 383 publications

(314 citation statements)

References 24 publications

(19 reference statements)

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“…The merits of the expertise-based RCT design have been discussed in several reports [4,18,22]. The objectives of our study included exploring surgeons' willingness and preference for the expertise-based design compared with the conventional RCT design.…”

Section: Discussionmentioning

confidence: 99%

“…It is possible that the lack of individual surgeon uncertainty may influence (consciously or unconsciously) how the surgeon performs the operation and the postoperative rehabilitation protocol that he or she prescribes [4]. Surgeons may unknowingly perform their preferred procedure more meticulously or follow up with these patients differently compared with patients who underwent the procedure that the surgeon does not have as much experience with, thereby biasing the results in favor of their preferred procedure.…”

Section: Discussionmentioning

confidence: 99%

“…An alternative RCT design, originally coined the nonrandomized surgeon design [22] and more recently referred to as the expertise-based RCT [4] may offer a practical solution to these barriers. In this type of trial, a surgeon with expertise in one of the procedures being evaluated is paired with a surgeon with expertise in the other procedure (ideally at the same institution).…”

Section: Introductionmentioning

confidence: 99%

“…For example, it may decrease the likelihood of procedural crossovers and enhance validity because unlike the conventional RCT, there is a low likelihood of differential expertise bias [4]. Several authors have explored the advantages and limitations of the expertise-based RCT design [4,18,22].…”

Section: Introductionmentioning

confidence: 99%

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Orthopaedic Surgeons Prefer to Participate in Expertise-based Randomized Trials

Bednarska

Bryant

Devereaux

2008

Clinical Orthopaedics &Amp; Related Research

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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 crosssectional 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 (Ó2005 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.

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

See 2 more Smart Citations

Orthopaedic Surgeons Prefer to Participate in Expertise-based Randomized Trials

Bednarska

Bryant

Devereaux

2008

Clinical Orthopaedics &Amp; Related Research

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“…A formal assessment of the quality of the evidence that guides the management of primary bone tumors, to our knowledge, has not previously been published. Such an assessment may be important, because the surgical literature includes many more observational studies than studies of other designs, a limitation that reflects the difficulties of conducting randomized trials in surgical patients [9].…”

Section: Introductionmentioning

confidence: 99%

What Are the Levels of Evidence on Which We Base Decisions for Surgical Management of Lower Extremity Bone Tumors?

Evaniew

Nuttall

Farrokhyar

et al. 2014

Clinical Orthopaedics &Amp; Related Research

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How to Use a Randomized Clinical Trial Addressing a Surgical Procedure

et al. 2016

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Because surgical procedures require clinicians to develop and maintain procedural expertise and because blinding in randomized clinical trials of such therapies is often challenging, their critical appraisal raises unique issues. Risk of bias of trials of surgical procedures increases if investigators fail to rigorously conceal allocation and, where possible, to ensure blinding of those involved in the trial. Variability in surgeons' expertise can also increase bias and lead to important limitations in applicability. To address these issues, this Users' Guide to the Medical Literature reviews the use of remote randomization systems, blinding, sham-controlled trials, split-body trials, expertise-based trials, and mechanistic vs practical trials. Consideration of risk of bias and applicability issues will allow clinicians to make optimal use of trials addressing surgical procedures.

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Need for expertise based randomised controlled trials

Cited by 383 publications

References 24 publications

Orthopaedic Surgeons Prefer to Participate in Expertise-based Randomized Trials

Orthopaedic Surgeons Prefer to Participate in Expertise-based Randomized Trials

What Are the Levels of Evidence on Which We Base Decisions for Surgical Management of Lower Extremity Bone Tumors?

How to Use a Randomized Clinical Trial Addressing a Surgical Procedure

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