Clinicians' views on the feasibility of surgical randomized trials in urogynecology: Results of a questionnaire survey

Bakali, Evangelia; Pitchforth, Emma; Tincello, Douglas G.; Kenyon, Sara; Slack, Mark; Toozs‐Hobson, Philip; Mayne, Christopher; Jones, David R.; Taylor, David

doi:10.1002/nau.20943

Cited by 12 publications

(9 citation statements)

References 34 publications

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“…Surgeons’ preferences are a well-recognised and accepted barrier to their participation in trials [10,55-58] but investigators in previous studies have not tried to understand these preferences, how they are formed or the evidence on which they are based, although there is some data to suggest that surgeons’ understanding is limited [56]. By contrast, several studies have explored the basis of patients’ treatment preferences [59-62].…”

Section: Discussionmentioning

confidence: 99%

Time to be BRAVE: is educating surgeons the key to unlocking the potential of randomised clinical trials in surgery? A qualitative study

Potter

Mills

Cawthorn

et al. 2014

Trials

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BackgroundWell-designed randomised clinical trials (RCTs) provide the best evidence to inform decision-making and should be the default option for evaluating surgical procedures. Such trials can be challenging, and surgeons’ preferences may influence whether trials are initiated and successfully conducted and their results accepted. Preferences are particularly problematic when surgeons’ views play a key role in procedure selection and patient eligibility. The bases of such preferences have rarely been explored. Our aim in this qualitative study was to investigate surgeons’ preferences regarding the feasibility of surgical RCTs and their understanding of study design issues using breast reconstruction surgery as a case study.MethodsSemistructured qualitative interviews were undertaken with a purposive sample of 35 professionals practicing at 15 centres across the United Kingdom. Interviews were transcribed verbatim and analysed thematically using constant comparative techniques. Sampling, data collection and analysis were conducted concurrently and iteratively until data saturation was achieved.ResultsSurgeons often struggle with the concept of equipoise. We found that if surgeons did not feel ‘in equipoise’, they did not accept randomisation as a method of treatment allocation. The underlying reasons for limited equipoise were limited appreciation of the methodological weaknesses of data derived from nonrandomised studies and little understanding of pragmatic trial design. Their belief in the value of RCTs for generating high-quality data to change or inform practice was not widely held.ConclusionThere is a need to help surgeons understand evidence, equipoise and bias. Current National Institute of Health Research/Medical Research Council investment into education and infrastructure for RCTs, combined with strong leadership, may begin to address these issues or more specific interventions may be required.

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Section: Discussionmentioning

confidence: 99%

Time to be BRAVE: is educating surgeons the key to unlocking the potential of randomised clinical trials in surgery? A qualitative study

Potter

Mills

Cawthorn

et al. 2014

Trials

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“…As mentioned previously IUT is widely established in clinical practice and the absence of this investigation prior to offering surgery is a potential barrier to clinicians' willingness to randomise their patients. Clinician surveys in other urogynaecology research have identified clinicians' views of perceived benefit and complications of the two arms as impacting participation [14]. Women may also not see the benefit of testing a test, believing that the results of any available test must guide their clinician and themselves to the most appropriate management.…”

Section: Discussionmentioning

confidence: 99%

“…So we need to establish whether sufficient clinicians are in equipoise and willing to recruit and randomise patients to a RCT. There is growing evidence in favour of pilot studies involving collection of both quantitative and qualitative data prior to embarking on this type of definitive RCT [14]. …”

Section: Introductionmentioning

confidence: 99%

INVESTIGATE-I (INVasive Evaluation before Surgical Treatment of Incontinence Gives Added Therapeutic Effect?): study protocol for a mixed methods study to assess the feasibility of a future randomised controlled trial of the clinical utility of invasive urodynamic testing

Murdoch

McColl

Howel

et al. 2011

Trials

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BackgroundUrinary incontinence is an important health problem to the individual sufferer and to health services. Stress and stress predominant mixed urinary incontinence are increasingly managed by surgery due to advances in surgical techniques. Despite the lack of evidence for its clinical utility, most clinicians undertake invasive urodynamic testing (IUT) to confirm a functional diagnosis of urodynamic stress incontinence before offering surgery for this condition. IUT is expensive, embarrassing and uncomfortable for women and carries a small risk. Recent systematic reviews have confirmed the lack of high quality evidence of effectiveness.The aim of this pilot study is to test the feasibility of a future definitive randomised control trial that would address whether IUT alters treatment decisions and treatment outcome in these women and would test its clinical and cost effectiveness.Methods/designThis is a mixed methods pragmatic multicentre feasibility pilot study with four components:-(a) A multicentre, external pilot randomised trial comparing basic clinical assessment with non-invasive tests and IUT. The outcome measures are rates of recruitment, randomisation and data completion. Data will be used to estimate sample size necessary for the definitive trial.(b) Qualitative interviews of a purposively sampled sub-set of women eligible for the pilot trial will explore willingness to participate, be randomised and their overall trial experience.(c) A national survey of clinicians to determine their views of IUT in this context, the main outcome being their willingness to randomise patients into the definitive trial.(d) Qualitative interviews of a purposively sampled group of these clinicians will explore whether and how they use IUT to inform their decisions.DiscussionThe pilot trial will provide evidence of feasibility and acceptability and therefore inform the decision whether to proceed to the definitive trial. Results will inform the design and conduct of the definitive trial and ensure its effectiveness in achieving its research aim.Trial registration numberCurrent Controlled Trials ISRCTN71327395 assigned 7th June 2010.

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“…This study has identified differences in the way women perceive research studies involving different intervention arms. There have been a number of studies published looking at barriers to recruitment6, 14, 15 both from the physician and the patient perspective but no one has looked at the types of studies patients would be willing to participate in terms of specific alternative treatment modalities.…”

Section: Discussionmentioning

confidence: 99%

Factors influencing women's participation in urogynecology research in the UK and USA

Bakali

Gafni-Kane

Botros

et al. 2011

Neurourology and Urodynamics

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Clinicians' views on the feasibility of surgical randomized trials in urogynecology: Results of a questionnaire survey

Cited by 12 publications

References 34 publications

Time to be BRAVE: is educating surgeons the key to unlocking the potential of randomised clinical trials in surgery? A qualitative study

Time to be BRAVE: is educating surgeons the key to unlocking the potential of randomised clinical trials in surgery? A qualitative study

INVESTIGATE-I (INVasive Evaluation before Surgical Treatment of Incontinence Gives Added Therapeutic Effect?): study protocol for a mixed methods study to assess the feasibility of a future randomised controlled trial of the clinical utility of invasive urodynamic testing

Factors influencing women's participation in urogynecology research in the UK and USA

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