Copious evidence has recently emerged to suggest that the outcomes of cancer surgery vary importantly between different surgeons. The magnitude of the difference in outcome between surgeons is often comparable to that we expect from treatments such as adjuvant chemotherapy. It is likely that differences in outcome between surgeons are attributable, at least in part, to identifiable aspects of surgical technique. This suggests that randomized trials to compare different surgical techniques would be of value;there is, however, a dearth of such trials. This is related to the serious practical challenges associated with implementing adequately powered studies. In this proposal, we propose a novel methodology - the """"""""clinically-integrated randomized trial"""""""" - for surgery research. This has been developed by systematic identification of the problems associated with surgery trials. The core principle is that the experience of the patient, doctor and other hospital staff is virtually indistinguishable irrespective of randomization. In particular, because outcome data are obtained directly from the patient electronic medical record, there is no requirement for burdensome questionnaires, forms or other procedures. Other key aspects of the clinically-integrated randomized trial include: minimal eligibility criteria;randomization of every patient as a routine part of clinical care;the use of a single """"""""master"""""""" protocol;factorial design such that several modifications to surgical technique can be evaluated simultaneously. We propose to pilot a clinically-integrated randomized trial testing three modifications to radical prostatectomy at a single institution. This would provide """"""""proof of principle"""""""" that trials on cancer surgery with high accrual rates can be conducted at low cost. The proposal has the enthusiastic support from the surgical leadership at the host institution, with the Chair of Surgery acting as key investigator of this grant and co-PI of the IRB protocol.
This is copious evidence that the outcomes of cancer surgery vary importantly between surgeons, likely due to differences in surgical technique. Yet there is dearth of randomized trials comparing different techniques of cancer surgery. We propose a novel methodology for surgery research developed by systematic identification of the practical problems associated with surgery trials. We intend to pilot this methodology in a trial comparing modifications to radical prostatectomy.
| Vickers, Andrew J; Bennette, Caroline; Touijer, Karim et al. (2012) Feasibility study of a clinically-integrated randomized trial of modifications to radical prostatectomy. Trials 13:23 |
| Vickers, Andrew J; Salz, Talya; Basch, Ethan et al. (2010) Electronic patient self-assessment and management (SAM): a novel framework for cancer survivorship. BMC Med Inform Decis Mak 10:34 |
| Vickers, Andrew J; Savage, Caroline J; Shouery, Marwan et al. (2010) Validation study of a web-based assessment of functional recovery after radical prostatectomy. Health Qual Life Outcomes 8:82 |
| Vickers, Andrew J; Scardino, Peter T (2009) The clinically-integrated randomized trial: proposed novel method for conducting large trials at low cost. Trials 10:14 |
