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Clinical research in surgery and the IDEAL framework

The quality of clinical research in surgery has long attracted criticism. Angelos Kolias, Clinical Lecturer in Neurosurgery (Department of Clinical Neurosciences and Surgery Theme, Cambridge Clinical Trials Unit) and IDEAL Collaboration Neurosurgical Lead, together with a multi-institutional writing group including surgeons, research trialists, methodologists, statisticians, ethicists, and experts in health technology assessment have developed an update to the original IDEAL Framework papers published in 2009.

High-quality randomised trials have proved difficult to undertake in surgery, and many surgical treatments have been adopted without adequate supporting evidence of efficacy and safety. This evidence gap can adversely affect research funding and commissioning decisions, lead to slow adoption of innovations, and permit widespread uptake of procedures that offer no benefit, or cause harm. 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. Earlier in the year, Angelos together with collaborators from the IDEAL Collaboration published a Health Policy paper in the Lancet, which aimed to assess methodological progress in surgical research over time.

The paper entitled “No Surgical Innovation without Evaluation: Evolution and Further Development of the IDEAL Framework and Recommendations” was published in the Annals of Surgery in April. It uses a PICO format to outline the key features of each IDEAL stage, outline reporting guidance for each stage and describe how to identify when an endpoint to a stage has been reached.

Posted on 21/05/2018