Progress in clinical research in surgery and IDEAL

Abstract

The quality of clinical research in surgery has long attracted criticism. High-quality randomised trials have proved difficult to undertake in surgery, and many surgical treatments have therefore been adopted without adequate supporting evidence of efficacy and safety. This evidence deficit can adversely affect research funding and reimbursement decisions, lead to slow adoption of innovations, and permit widespread adoption of procedures that offer no benefit, or cause harm. Improvement in the quality of surgical evidence would therefore be valuable. The Idea, Development, Exploration, Assessment, and Long-term Follow-up (IDEAL) Framework and Recommendations specify desirable qualities for surgical studies, and outline an integrated evaluation pathway for surgery, and similar complex interventions. We used the IDEAL Recommendations to assess methodological progress in surgical research over time, assessed the uptake and influence of IDEAL, and identified the challenges to further methodological progress. Comparing studies from the periods 2000-04 and 2010-14, we noted apparent improvement in the use of standard outcome measures, adoption of Consolidated Standards of Reporting Trials (CONSORT) standards, and assessment of the quality of surgery and of learning curves, but no progress in the use of qualitative research or reporting of modifications during procedure development. Better education about research, integration of rigorous evaluation into routine practice and training, and linkage of such work to awards systems could foster further improvements in surgical evidence. IDEAL has probably contributed only slightly to the improvements described to date, but its uptake is accelerating rapidly. The need for the integrated evaluation template IDEAL offers for surgery and other complex treatments is becoming more widely accepted.

Locoregional recurrences after transanal total mesorectal excision of rectal cancer during implementation

“…As stated in the IDEAL framework, a new innovation or technique should be evaluated stepwise, and not be implemented broadly before standardized indications and procedures have been developed. In this way, adverse effects and consistent outcomes can be established during the learning curve, which new centres can set as a benchmark 37 . The surgical community should focus on demonstrating oncological safety rather than surrogate endpoints for new innovative surgical techniques for patients with cancer.…”

Value of surgical pilot and feasibility study protocols

“…The initial IDEAL publication 21 , however, was largely theoretical with little practical guidance about how PFS should be performed. Recently published updated IDEAL recommendations 22 now provide some clarification regarding the role of PFS in surgery as a result of recognition that the original IDEAL guidance published in 2009 21 had little impact on the design and conduct of surgical PFS 37 . The updated IDEAL framework 22 suggests several feasibility issues to consider in stage 2a/2b studies, including estimating effect size, defining intervention quality and standards, evaluating learning curves, exploring subgroup differences, eliciting key stakeholder values and preferences, and analysis of adverse events.…”

Funders improved the management of learning and clustering effects through design and analysis of randomized trials involving surgery

“…Furthermore, these results provide insight into the promising role of the funder as a driver to improving the, long criticized, surgical evidence base. The funder, who has influence over whether and how studies are carried out and has been suggested as a driver for improving the quality of research during the period of growth for surgical trials [3], can play a valuable role in ensuring that future trials do not have the same shortfalls as those in the past.…”

“…Randomized controlled trials (RCTs) are recognized as providing the highest level of evidence, second only to systematic reviews of such trials [1]. The need for surgical randomized trials is well recognized [2,3], and this has led to a push for growth in recent years [3,4]. Leading research organizations are supporting this growth through establishing a number of initiatives and research objectives, ultimately aiming to improve the global surgical evidence base [5e10].…”