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Published in: Trials 1/2015

Open Access 01-12-2015 | Methodology

Novel ways to explore surgical interventions in randomised controlled trials: applying case study methodology in the operating theatre

Authors: Natalie S. Blencowe, Jane M. Blazeby, Jenny L. Donovan, Nicola Mills

Published in: Trials | Issue 1/2015

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Abstract

Background

Multi-centre randomised controlled trials (RCTs) in surgery are challenging. It is particularly difficult to establish standards of surgery and ensure that interventions are delivered as intended. This study developed and tested methods for identifying the key components of surgical interventions and standardising interventions within RCTs.
Qualitative case studies of surgical interventions were undertaken within the internal pilot phase of a surgical RCT for obesity (the By-Band study). Each case study involved video data capture and non-participant observation of gastric bypass surgery in the operating theatre and interviews with surgeons. Methods were developed to transcribe and synchronise data from video recordings with observational data to identify key intervention components, which were then explored in the interviews with surgeons.

Results

Eight qualitative case studies were undertaken. A novel combination of video data capture, observation and interview data identified variations in intervention delivery between surgeons and centres. Although surgeons agreed that the most critical intervention component was the size and shape of the gastric pouch, there was no consensus regarding other aspects of the procedure. They conceded that evidence about the ‘best way’ to perform bypass was lacking and, combined with the pragmatic nature of the By-Band study, agreed that strict standardisation of bypass might not be required.

Conclusions

This study has developed and tested methods for understanding how surgical interventions are designed and delivered delivered in RCTs. Applying these methods more widely may help identify key components of interventions to be delivered by surgeons in trials, enabling monitoring of key components and adherence to the protocol. These methods are now being tested in the context of other surgical RCTs.

Trial registration

Current Controlled Trials ISRCTN00786323, 05/09/2011.
Literature
1.
2.
Barkun JS, Aronson JK, Feldman LS, Maddern GJ, Strasberg SM, Balliol C, et al. Evaluation and stages of surgical innovations. Lancet. 2009;374:1089–96.CrossRefPubMed
3.
Craig P, Dieppe P, Macintyre S, Michie S, Nazareth I, Petticrew M, et al. Developing and evaluating complex interventions: the new Medical Research Council guidance. BMJ. 2008;337:a1655.CrossRefPubMedPubMedCentral
4.
5.
McCulloch P, Altman DG, Campbell WB, Flum DR, Glasziou P, Marshall JC, et al. No surgical innovation without evaluation: the IDEAL recommendations. Lancet. 2009;374:1105–12.CrossRefPubMed
6.
Glasziou P, Altman DG, Bossuyt P, Boutron I, Clarke M, Julious S, et al. Reducing waste from incomplete or unusable reports of biomedical research. Lancet. 2014;383:267–76.CrossRefPubMed
7.
Blencowe N, Mills N, Whiting P, Blazeby J. Providing adequate and practical descriptions in surgical trials. BMJ. 2013;347:f6143.CrossRefPubMed
8.
Medical Research Council. Developing and evaluating complex interventions: new guidance. London: Medical Research Council; 2008.
9.
Baxter P, Jack S. Qualitative case study methodology: study design and implementation for novice researchers. Qual Rep. 2008;13:544.
10.
Yin RK. Case study research: design and methods. 4th ed. Thousand Oaks: Sage Publications; 2009.
11.
Rogers CA, Welbourn R, Byrne J, Donovan JL, Reeves BC, Wordsworth S, et al. The By-Band study: gastric bypass or adjustable gastric band surgery to treat morbid obesity: study protocol for a multi-centre randomised controlled trial with an internal pilot phase. Trials. 2014;15:53.CrossRefPubMedPubMedCentral
12.
Blazeby JM, Byrne J, Welbourn R. What is the most effective operation for adults with severe and complex obesity? BMJ. 2014;348g:1763.CrossRef
13.
Higa KD, Boone KB, Ho T. Complications of the laparoscopic Roux-en-Y gastric bypass: 1,040 patients--what have we learned? Obes Surg. 2000;10:509–13.CrossRefPubMed
14.
Aggarwal R, Boza C, Hance J, Leong J, Lacy A, Darzi A. Skills acquisition for laparoscopic gastric bypass in the training laboratory: an innovative approach. Obes Surg. 2007;17:19–27.CrossRefPubMed
15.
Rowley J. Using case studies in research. Manage Res News. 2002;25:16–27.CrossRef
16.
Braun V, Clarke V. Using thematic analysis in psychology. Qual Res Psychol. 2006;3:77–101.CrossRef
17.
18.
Boutron I, Moher D, Altman DG, Schulz KF, Ravaud P, Group C. Extending the CONSORT statement to randomized trials of nonpharmacologic treatment: explanation and elaboration. Ann Intern Med. 2008;148:295–309.CrossRefPubMed
19.
Blencowe NS, Boddy AP, Harris A, Hanna T, Whiting P, Cook JA, et al. Systematic review of intervention design and delivery in pragmatic and explanatory surgical randomized clinical trials. Br J Surg. 2015;102:1037–47.CrossRefPubMed
20.
Cook JA, McCulloch P, Blazeby JM, Beard DJ, Marinac-Dabic D, Sedrakyan A, et al. IDEAL framework for surgical innovation 3: randomised controlled trials in the assessment stage and evaluations in the long term study stage. BMJ. 2013;346:f2820.CrossRefPubMedPubMedCentral
21.
22.
Blencowe N, Boddy A, Harris A, Hanna T, Whiting P, Cook J, et al. Accounting for intervention complexity in rcts in surgery: new approaches for intervention definition and methods for monitoring fidelity. Trials. 2013;14(Suppl 1):O86.CrossRefPubMedCentral
Metadata
Title
Novel ways to explore surgical interventions in randomised controlled trials: applying case study methodology in the operating theatre
Authors
Natalie S. Blencowe
Jane M. Blazeby
Jenny L. Donovan
Nicola Mills
Publication date
01-12-2015
Publisher
BioMed Central
Published in
Trials / Issue 1/2015
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-015-1127-x

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