No Surgical Innovation Without Evaluation

Hirst, Allison; Philippou, Yiannis; Blazeby, Jane M; Campbell, Bruce; Campbell, Marion K; Feinberg, Joshua A; Rovers, Maroeska M.; Blencowe, Natalie S; Pennell, Christopher; Quinn, Tom; Rogers, Wendy; Cook, Jonathan; Kolias, Angelos G.; Agha, Riaz; Dahm, Philipp; Sedrakyan, Art; McCulloch, Peter

doi:10.1097/sla.0000000000002794

Cited by 292 publications

(129 citation statements)

References 52 publications

(37 reference statements)

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“…As doctors, we have a duty of care to our patients. In our view, this also extends to the rigorous evaluation of novel techniques, approaches, and devices [8]. This is important from the non-maleficence and safety perspective.…”

Section: Cisternostomy For Traumatic Brain Injury-rigorous Evaluationmentioning

confidence: 89%

“…This raises questions around the statement that "waiver of consent was granted because the procedure was part of our written algorithm for the management of sTBI", given that the treatment algorithm would be different depending on who was the on-call neurosurgeon. This issue along with the fact that the published data on cisternostomy for TBI are very sparse indicates that the study should have happened prospectively in the context of a research protocol approved by an ethics committee [8].…”

Section: Cisternostomy For Traumatic Brain Injury-rigorous Evaluationmentioning

confidence: 99%

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Cisternostomy for traumatic brain injury—rigorous evaluation is necessary

et al. 2020

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Section: Cisternostomy For Traumatic Brain Injury-rigorous Evaluationmentioning

confidence: 89%

Section: Cisternostomy For Traumatic Brain Injury-rigorous Evaluationmentioning

confidence: 99%

Cisternostomy for traumatic brain injury—rigorous evaluation is necessary

et al. 2020

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“…Numerous retrospective, prospective and case-controlled studies have indeed demonstrated the three steps of a robust evaluation of a new surgical procedure/ technology [1]: feasibility, safety and effectiveness of the robotic system. In addition, these studies resulted in equal or better specimen-oriented outcomes such as quality of TME, CRM, lymph node yield and many more.…”

mentioning

confidence: 99%

“…The IDEAL framework for new surgical procedures/ devices describes five stages of evaluation: idea, development, exploration, assessment and long-term study [1]. All this has been done for colorectal surgery since the introduction of the robot in 2000 without any clearly proven patient-related benefits.…”

mentioning

confidence: 99%

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The Robot: a big disappointment, or just early days?

Hahnloser¹

2018

Colorectal Disease

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Analysis of Rates of Completion, Delays, and Participant Recruitment in Randomized Clinical Trials in Surgery

et al. 2023

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ImportanceDiscontinuation and nonpublication are established sources of avoidable waste among surgical trials, but rates of delayed completion and recruiting shortfalls remain unclear.ObjectivesTo examine the rate of delayed completion, incomplete enrollment, and discontinuation among randomized clinical trials in surgical populations and the duration of delays and extent of recruiting shortfalls among these trials.Design, Setting, and ParticipantsThis cross-sectional study examined randomized clinical trials in surgical populations registered on ClinicalTrials.gov between January 1, 2010, and December 31, 2014. Analysis was conducted between October 27, 2021, and June 30, 2022.Main Outcomes and MeasuresThe main outcomes were the percentages of trials completed on time or with full enrollment. Delays and recruiting shortfalls were identified by comparing projected enrollment and study timeframes prespecified at the time of registration with the actual study duration and enrollment reported on completion or discontinuation. Absolute and relative differences between planned and actual trial conduct were presented for discontinued trials and those completed with delays or recruiting shortfalls.ResultsIn total, 2542 randomized clinical trials in surgical populations were included in the study sample, of which 370 (14.6%; 95% CI, 13.2%-15.9%) were completed both on time and with full enrollment. Approximately 1 in 5 trials (20.4%; 95% CI, 18.9%-22.0%) were completed within their planned timeframe, and 1166 trials (45.9%; 95% CI, 43.9%-47.8%) met their prespecified enrollment target. The median delay among completed trials was 12.2 months (IQR, 5.1-24.3 months) or 66.7% (IQR, 30.1%-135.8%) longer than planned. Among completed trials that did not meet their prespecified enrollment target, the median recruiting shortfall was equivalent to 31.0% (IQR, 12.7%-55.5%) of the planned study sample. A total of 546 trials (21.5%; 95% CI, 19.9%-23.1%) were discontinued. The median time to discontinuation was 26.4 months (IQR, 15.2-45.7 months), and the median recruiting shortfall among discontinued trials was equivalent to 92.7% (IQR, 65.0%-100.0%) of the trial’s prespecified enrollment target.Conclusions and RelevanceThis cross-sectional study found that delayed completion, recruiting shortfalls, and untimely discontinuation were common among surgical trials. These findings highlight the importance of ensuring that investigators and funders do not overestimate the feasibility of planned trials.

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No Surgical Innovation Without Evaluation

Abstract: The intention of this article is to widen the practical use of IDEAL by clarifying the rationale for and practical details of the Recommendations. Additional research based on the experience of implementing these Recommendations is needed to further improve them.

Cited by 292 publications

References 52 publications

Cisternostomy for traumatic brain injury—rigorous evaluation is necessary

Cisternostomy for traumatic brain injury—rigorous evaluation is necessary

The Robot: a big disappointment, or just early days?

Analysis of Rates of Completion, Delays, and Participant Recruitment in Randomized Clinical Trials in Surgery

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