Do you know of a surgical or interventional procedure in development that needs better evidence to support its use? Would you be interested in working with IDEAL in developing and carrying out a prospective development study?
The IDEAL recommendation for procedures in the Development stage (2a) is the prospective development study (PDS). The Development stage is when a technique or device is still being modified iteratively as a result of lessons learned on a case by case basis in the first cohort of patients. Traditionally, published research on procedures at this stage has been in the form of the retrospective case series, which is criticised for its significant selection bias and other flaws. The prospective development study reduces the risk of bias but also provides more complete information about the process of innovation which allows the reader to understand how the technique evolved to its current state and how applicable it may be to other settings. There are few procedures that have been published as prospective development studies, but two recent examples include minimally invasive oesophagectomy, published by Jane Blazeby and colleagues in 2011, and focal ablation of prostate cancer, published by Mark Emberton and colleagues in 2012.
No specific formal outline of a PDS exists, but IDEAL recommends that it includes the following:
- Registered study protocol
- Clear description of patient selection criteria
- Recording of proportion of eligible patients selected
- Ethical consideration for reasonable precautions against harm
- Clear description of procedure
- Sequential reporting of ALL cases over time, showing outcome in each case
- Description of changes to procedure and indication,showing their timings on the sequential display of cases
- (Where appropriate) Use of statistical process control (SPC) methods
- Relevant outcomes described, including unexpected outcomes
- Use of standardised outcome measures
What other features should be included in a prospective development study? In order to improve the quality of surgical evidence and propagate the use of prospective development studies, ultimately phasing retrospective case series out of the literature, IDEAL needs your input. We would be interested in working with suitable partners who are developing surgical innovations at this early stage, to develop and report your work in the way we describe, and in interviewing you afterwards to develop a qualitative analysis of the strengths and weaknesses of the IDEAL Recommendations for this type of study. If you would like to explore this possibility, please contact the IDEAL Collaboration.
 Blazeby JM, Blencowe NS, Titcomb DR, Metcalfe C, Hollowood AD, Barham CP. Demonstration of the IDEAL recommendations for evaluating and reporting surgical innovation in minimally invasive oesophagectomy. Br J Surg. 2011 Apr;98(4):544-51. doi: 10.1002/bjs.7387. Epub 2011 Jan 18.
 Ahmed HU, Hindley RG, Dickinson L, Freeman A, Kirkham AP, Sahu M, Scott R, Allen C, Van der Meulen J, Emberton M. Focal therapy for localised unifocal and multifocal prostate cancer: a prospective development study. Lancet Oncol. 2012 Jun;13(6):622-32. doi: 10.1016/S1470-2045(12)70121-3. Epub 2012 Apr 17.