Systematic review of intervention design and delivery in pragmatic and explanatory surgical randomized clinical trials

Blencowe, Natalie S; Boddy, Alex; Harris, Alexander; Hanna, Thomas; Whiting, Penny; Cook, Jonathan; Blazeby, Jane M

doi:10.1002/bjs.9808

Cited by 41 publications

(39 citation statements)

References 106 publications

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“…For the purposes of the review, a surgical intervention was defined as any 'procedure involving an incision with instruments usually performed in an operating theatre and normally involving anesthesia and/or respiratory assistance' [9]. Micro-costing was defined as the 'direct enumeration and costing of every input consumed in the treatment of a particular patient' [4].…”

Section: Selection Of Papersmentioning

confidence: 99%

The use of micro-costing in economic analyses of surgical interventions: a systematic review

Potter

Davies

et al. 2020

Health Econ Rev

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Background: Compared with conventional top down costing, micro-costing may provide a more accurate method of resource-use assessment in economic analyses of surgical interventions, but little is known about its current use. The aim of this study was to systematically-review the use of micro-costing in surgery. Methods: Comprehensive searches identified complete papers, published in English reporting micro-costing of surgical interventions up to and including 22nd June 2018. Studies were critically appraised using a modified version of the Consensus on Health Economic Criteria (CHEC) Checklist. Study demographics and details of resources identified; methods for measuring and valuing identified resources and any cost-drivers identified in each study were summarised. Results: A total of 85 papers were identified. Included studies were mainly observational comparative studies (n = 42, 49.4%) with few conducted in the context of a randomised trial (n = 5, 5.9%). The majority of studies were single-centre (n = 66, 77.6%) and almost half (n = 40, 47.1%) collected data retrospectively. Only half (n = 46, 54.1%) self-identified as being 'micro-costing' studies. Rationale for the use of micro-costing was most commonly to compare procedures/techniques/processes but over a third were conducted specifically to accurately assess costs and/or identify cost-drivers. The most commonly included resources were personnel costs (n = 76, 89.4%); materials/disposables (n = 76, 89.4%) and operating-room costs (n = 62,72.9%). No single resource was included in all studies. Most studies (n = 72, 84.7%) identified key cost-drivers for their interventions. Conclusions: There is lack of consistency regarding the current use of micro-costing in surgery. Standardising terminology and focusing on identifying and accurately costing key cost-drivers may improve the quality and value of micro-costing in future studies. Trial registration: PROSPERO registration CRD42018099604.

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Section: Selection Of Papersmentioning

confidence: 99%

The use of micro-costing in economic analyses of surgical interventions: a systematic review

Potter

Davies

et al. 2020

Health Econ Rev

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“…Clearly, in trials such as UK FROST, a position between these extremes, which respectively characterize explanatory and pragmatic research, would be desirable. In practice, this has seldom been achieved: a recent, large systematic review of surgical trial interventions (comparably complex to interventions in physiotherapy trials) revealed that fewer than one third were reportedly standardized, and fewer than one third were monitored for adherence, regardless of whether the trials were claimed to be explanatory or pragmatic [20]. The design, conduct, monitoring and reporting of rehabilitation in surgical trials has been particularly poor, but the recent ProFHER (Proximal Fracture of Humerus Evaluation by Randomisation) trial, a surgical trial with a physiotherapy intervention group, set foundational standards in these regards [21].…”

Section: Discussionmentioning

confidence: 99%

Physiotherapy for primary frozen shoulder in secondary care: Developing and implementing stand-alone and post operative protocols for UK FROST and inferences for wider practice

et al. 2020

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Objectives The United Kingdom Frozen Shoulder Trial (UK FROST) compares stand-alone physiotherapy and two operative procedures, both with post operative rehabilitation, for primary frozen shoulder in secondary care. We developed physiotherapy protocols for UK FROST, incorporating best evidence but recognizing uncertainty and allowing flexibility. Methods We screened a UK Department of Health systematic review and UK evidence-based guidelines (Hanchard et al., 2012; Maund et al., 2012) for recommendations, and previous surveys of UK physiotherapists (Hanchard et al., 2011, 2013) for strong consensus. We conducted a two-stage, questionnaire-based, modified Delphi survey of shoulder specialist physiotherapists in the UK National Health Service. This required positive, negative or neutral ratings of possible interventions in four clinical contexts (stand-alone physiotherapy for, respectively, predominantly painful and predominantly stiff frozen shoulder; and post operative physiotherapy for, respectively, predominantly painful and predominantly stiff frozen shoulder). We proposed respectively mandating or recommending interventions with 100% and 90% positive consensus, and respectively disallowing or discouraging interventions with 90% and 80% negative consensus. Other interventions would be optional. Results The systematic review and guideline recommended including steroid injection and manual mobilizations in non-operative care, and we mandated these for stand-alone physiotherapy. Consensus in the pre-existing surveys strongly favoured advice, education and home exercises, which we mandated across contexts. The Delphi survey led to recommendation of some supervised exercise modalities, plus the disallowing or discouragement-in various contexts-of immobilization and some 'higher-tech' electrotherapies and alternative therapies. Conclusions We developed physiotherapy protocols despite incomplete empirical evidence. Their clear structure enabled implementation in data-sheets designed to facilitate recording, monitoring of fidelity and reporting of interventions. Other trials involving physiotherapy may benefit from this approach.

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“…Standardization of an intervention is an integral part of a controlled trial seeking to compare different treatments. Surgical standardization among trials, however, has been a challenge, considering that standardizing the complexity of a surgical procedure is much more difficult than standardizing the dose of a medicine, and it has been demonstrated that a large number of RCTs involving surgical procedures, around 70% of the studies among 160 trials included in a recent systematic review, has had problems with standardization of the procedure and with monitoring the adherence to the standards . In only one of the included studies in this review, a protocol clearly described a sequence to standardize the procedure, stating which steps of the procedure were mandated, prohibited or optional, and clearly describing allowed flexibilities.…”

Section: Discussionmentioning

confidence: 99%

Does sacrocolpopexy present heterogeneity in its surgical technique? A systematic review

Moroni

Juliato

Cosson

et al. 2018

Neurourology and Urodynamics

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Systematic review of intervention design and delivery in pragmatic and explanatory surgical randomized clinical trials

Cited by 41 publications

References 106 publications

The use of micro-costing in economic analyses of surgical interventions: a systematic review

The use of micro-costing in economic analyses of surgical interventions: a systematic review

Physiotherapy for primary frozen shoulder in secondary care: Developing and implementing stand-alone and post operative protocols for UK FROST and inferences for wider practice

Does sacrocolpopexy present heterogeneity in its surgical technique? A systematic review

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