Article Text
Abstract
Introduction The IDEAL framework recognises the importance of modifications in surgical innovation, yet little is known about reporting standards. We investigated how IDEAL recommendations influenced reporting of surgical modifications.
Methods Systematic searches for published studies reporting innovative surgical procedures/devices and citing the 13 main IDEAL papers were undertaken. Verbatim text describing modifications including contextual data were extracted and analysed inductively using thematic analysis.
Results Of 1071 records screened, 104 papers were included (n=87 (83.6%) study reports; n=17 (16.3%) protocols). Modifications were reported in 76 (73.1%) studies, including changes to technique, patient selection and device design. Depth and breadth of modification reporting varied widely with variable emphasis on prior, current and future modifications. Of the total 104 studies, 62 (59.6%) were categorised as IDEAL stages 2a or 2b and most frequently involved urological innovations (n=38 (36.5%)).
Conclusions Reporting modifications is imperative for evaluating surgical innovation but could be enhanced. Findings from this review will inform the development of a framework for reporting modifications that will be tested and refined through qualitative interviews with innovating surgeons. This will complement the IDEAL framework and further promote shared learning, therefore avoiding the repetition of harmful/ineffective modifications and enhancing patient safety.
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