Dataset Information

Protocol for developing quality assurance measures to use in surgical trials: an example from the ROMIO study.

ABSTRACT:

Introduction

Randomised controlled trials (RCTs) in surgery are frequently criticised because surgeon expertise and standards of surgery are not considered or accounted for during study design. This is particularly true in pragmatic trials (which typically involve multiple centres and surgeons and are based in 'real world' settings), compared with explanatory trials (which are smaller and more tightly controlled).

Objective

This protocol describes a process to develop and test quality assurance (QA) measures for use within a predominantly pragmatic surgical RCT comparing minimally invasive and open techniques for oesophageal cancer (the NIHR ROMIO study). It builds on methods initiated in the ROMIO pilot RCT.

Methods and analysis

We have identified three distinct types of QA measure: (i) entry criteria for surgeons, through assessment of operative videos, (ii) standardisation of operative techniques (by establishing minimum key procedural phases) and (iii) monitoring of surgeons during the trial, using intraoperative photography to document key procedural phases and standardising the pathological assessment of specimens. The QA measures will be adapted from the pilot study and tested iteratively, and the video and photo assessment tools will be tested for reliability and validity.

Ethics and dissemination

Ethics approval was obtained (NRES Committee South West-Frenchay, 25 April 2016, ref: 16/SW/0098). Results of the QA development study will be submitted for publication in a peer-reviewed journal.

Trial registration number

ISRCTN59036820, ISRCTN10386621.

SUBMITTER: Blencowe NS

PROVIDER: S-EPMC6429900 | biostudies-literature | 2019 Mar

REPOSITORIES: biostudies-literature

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Publications

Protocol for developing quality assurance measures to use in surgical trials: an example from the ROMIO study.

Blencowe Natalie S NS Skilton Anni A Gaunt Daisy D Brierley Rachel R Hollowood Andrew A Dwerryhouse Simon S Higgs Simon S Robb William W Boddy Alex A Hanna George G Barham C Paul CP Blazeby Jane J

BMJ open 20190301 3

<h4>Introduction</h4>Randomised controlled trials (RCTs) in surgery are frequently criticised because surgeon expertise and standards of surgery are not considered or accounted for during study design. This is particularly true in pragmatic trials (which typically involve multiple centres and surgeons and are based in 'real world' settings), compared with explanatory trials (which are smaller and more tightly controlled).<h4>Objective</h4>This protocol describes a process to develop and test qua ...[more]

PMID: 30826769

Similar Datasets

Project description:BackgroundQuality assurance for acute in-hospital care in Germany is based on compulsory comparisons between institutions, so-called external quality assurance (EQA). The effectiveness of EQA has not yet been adequately studied. The purpose of the QUASCH project, which is supported by the Innovation Fund of the Federal Joint Committee, is to investigate the association between EQA and health care outcomes, specifically with respect to stroke.MethodsThe analyses were based on data from 379 825 patients insured by the AOK health insurance fund who were acutely admitted to a hospital because of stroke over the period 2007-2017. Data on 47 659 patients were derived from EQA documentation in the state of Hesse, in which stroke EQA had already been introduced in 2003; data on the remaining 332 166 patients were from other federal states, where 117 734 of these patients had been treated under EQA conditions. The association of EQA with mortality over the period of observation was analyzed by multivariate Cox regression, with the following covariates: age, sex, comorbidities, time period of occurrence, nursing care level, type of stroke, socio-economic deprivation in the region of origin, and treatment in a stroke unit.ResultsCompared to treatment without EQA, mortality risk under EQA in the state of Hesse was significantly lower (hazard ratio [HR]: 0.93; 95% confidence interval: [0.92; 0.95]). The reduction in mortality risk with EQA was somewhat lower in the other federal states (HR: 0.96 [0.95; 0.97]). Treatment in a stroke unit was associated with a mortality risk that was lower still (HR: 0.86 [0.85; 0.87]). Mortality risk rose with age, comorbidities, and need for nursing care; it was lower in women and in persons whose stroke occurred in a later period.ConclusionQuality assurance measures are associated with lower mortality risk after stroke. The concentration of care in specially qualified institutions is associated with stronger effects than EQA alone.

Dataset Information

Protocol for developing quality assurance measures to use in surgical trials: an example from the ROMIO study.

Introduction

Objective

Methods and analysis

Ethics and dissemination

Trial registration number

Publications

Protocol for developing quality assurance measures to use in surgical trials: an example from the ROMIO study.

Similar Datasets

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