ABSTRACT
There is a lack of trials of interventional procedures, such as surgery, with many authors issuing repeated call for more studies [1,2]. However, the level has remained low in comparison with other medical areas and speci cally pharmacological-based interventions. As noted elsewhere in this book, a randomized evaluation of nonpharmacological interventions raises distinct issues that require careful consideration. This is particularly the case
CONTENTS
9.1 Background ................................................................................................. 103 9.2 Consideration of the Potential Bene ts of Expertise-Based
Trial Design................................................................................................. 105 9.2.1 Differential Expertise .................................................................... 105 9.2.2 Protection from Other Potential Biases ...................................... 106 9.2.3 Recruitment of Surgeons/Patients .............................................. 106
9.3 Challenges Faced in Conducting EB Trials ............................................ 107 9.3.1 How Can Expertise Be De ned? ................................................. 107 9.3.2 What Is the Impact on the Required Sample Size? ................... 107 9.3.3 How Does the Expertise-Based Design Differ
in Trial Organization? ................................................................... 108 9.3.4 To Whom Are the Results Generalizable? .................................. 108
9.4 Usage and Examples .................................................................................. 108 9.4.1 SPRINT Trial ................................................................................... 109 9.4.2 Open versus EVAR Repair............................................................ 109 9.4.3 HTO versus UKA Repair .............................................................. 110
9.5 Conclusion .................................................................................................. 110 References ............................................................................................................. 111
for those that are skill-dependent. An alternative trial design, the expertisebased (EB) trial design, has been proposed for evaluations of such interventions [3,4]. This trial design potentially overcomes a number of the objections to a conventional design [5].
