William Shaw1, Gunvor Semb1,2. 1. a School of Dentistry , University of Manchester , Manchester , UK. 2. b Department of Plastic and Reconstructive Surgery , Oslo University Hospital Rikshospitalet , Oslo , Norway.
Abstract
BACKGROUND AND AIMS: Longstanding uncertainty surrounds the selection of surgical protocols for unilateral cleft lip and palate (UCLP), and randomised trials have only occasionally been performed. The Scandcleft Project consists of three trials initiated in 1997. The results at age 5 have been published in the series of reports that precede this manuscript, which aims to distill some of the issues that future trialists may need to address. METHOD: The shared experience of this group of trials is reviewed with reference to the current literature on trial management and, more specifically, trials of surgical technique and timing. RESULTS: The main discussion points relate to the challenges associated with research bureaucracy, learning curve, individuality of skill, and ethics. CONCLUSIONS: Compliance with current regulatory requirements for clinical trials and recruitment rates for cleft sub-types represent substantial challenges. Mastery of new surgical techniques prior to trials raises important ethical issues, although recent reports in the wider surgical literature suggest that learning may be hastened with the assistance of anonymised peer review ratings of intraoperative performance. The three Scandcleft Trials succeeded in meeting the planned recruitment targets, and completed follow-up with remarkably high retention rates (99.3%). The design of the study required the majority of participating surgeons to master a new technique and, although overall outcomes were comparable with those in the literature, the associated learning curve increased postoperative complications in two of the trials. TRIAL REGISTRATION: ISRCTN29932826.
BACKGROUND AND AIMS: Longstanding uncertainty surrounds the selection of surgical protocols for unilateral cleft lip and palate (UCLP), and randomised trials have only occasionally been performed. The Scandcleft Project consists of three trials initiated in 1997. The results at age 5 have been published in the series of reports that precede this manuscript, which aims to distill some of the issues that future trialists may need to address. METHOD: The shared experience of this group of trials is reviewed with reference to the current literature on trial management and, more specifically, trials of surgical technique and timing. RESULTS: The main discussion points relate to the challenges associated with research bureaucracy, learning curve, individuality of skill, and ethics. CONCLUSIONS: Compliance with current regulatory requirements for clinical trials and recruitment rates for cleft sub-types represent substantial challenges. Mastery of new surgical techniques prior to trials raises important ethical issues, although recent reports in the wider surgical literature suggest that learning may be hastened with the assistance of anonymised peer review ratings of intraoperative performance. The three Scandcleft Trials succeeded in meeting the planned recruitment targets, and completed follow-up with remarkably high retention rates (99.3%). The design of the study required the majority of participating surgeons to master a new technique and, although overall outcomes were comparable with those in the literature, the associated learning curve increased postoperative complications in two of the trials. TRIAL REGISTRATION: ISRCTN29932826.
Entities:
Keywords:
Randomised controlled trials; Scandcleft; learning curve; multicentre study; skill; unilateral cleft lip and palate surgery
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