Measuring clinical uncertainty as a preliminary step to randomized controlled trials

Fahed, Robert; Darsaut, T.E.; Farzin, Behzad; Chagnon, Miguel; Raymond, Jean

doi:10.1016/j.jclinepi.2019.04.011

Cited by 6 publications

(6 citation statements)

References 9 publications

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“…The degree of clinical uncertainty or equipoise within the surgical community is measured by testing the likelihood of receiving the same response when the same patient is presented to a different surgeon or to the same surgeon twice. 13,15 The clinical dilemma we wanted to test in this study concerns the propriety of performing repeat surgery for recurrent GBM patients in routine practice. This type of dilemma calls for a different type of clinical trial than most clinical research which aims to verify the promising benefit of a therapeutic innovation.…”

Section: Discussionmentioning

confidence: 99%

“…11,12 A common conception regarding the propriety of randomly allocating treatment options is that there should be sufficient disagreement, uncertainty, or "equipoise" in the expert community regarding how best to proceed in order to justify a trial. 13,14 Methods to measure such uncertainty have recently been described. 13,15 The goal of the present study was to measure the degree of clinical uncertainty or equipoise among general and neuro-oncology trained neurosurgeons by testing the repeatability of decisions to reoperate versus other management options for a series of diverse patients with recurrent GBM.…”

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confidence: 99%

“…13,14 Methods to measure such uncertainty have recently been described. 13,15 The goal of the present study was to measure the degree of clinical uncertainty or equipoise among general and neuro-oncology trained neurosurgeons by testing the repeatability of decisions to reoperate versus other management options for a series of diverse patients with recurrent GBM.…”

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confidence: 99%

“…Randomized trials of neurosurgical treatments remain difficult to conduct 11,12. A common conception regarding the propriety of randomly allocating treatment options is that there should be sufficient disagreement, uncertainty, or “equipoise” in the expert community regarding how best to proceed in order to justify a trial 13,14. Methods to measure such uncertainty have recently been described 13,15.…”

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confidence: 99%

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Clinical Uncertainty and Equipoise in the Management of Recurrent Glioblastoma

Patel¹,

Au²,

Davis³

et al. 2021

American Journal of Clinical Oncology

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Background: A significant proportion of glioblastoma (GBM) patients are considered for repeat resection, but evidence regarding best management remains elusive. Our aim was to measure the degree of clinical uncertainty regarding reoperation for patients with recurrent GBM. Methods:We first performed a systematic review of agreement studies examining the question of repeat resection for recurrent GBM. An electronic portfolio of 37 pathologically confirmed recurrent GBM patients including pertinent magnetic resonance images and clinical information was assembled. To measure clinical uncertainty, 26 neurosurgeons from various countries, training backgrounds, and years' experience were asked to select best management (repeat surgery, other nonsurgical management, or conservative), confidence in recommended management, and whether they would include the patient in a randomized trial comparing surgery with nonsurgical options. Agreement was evaluated using κ statistics. Results:The literature review did not reveal previous agreement studies examining the question. In our study, agreement regarding best management of recurrent GBM was slight, even when management options were dichotomized (repeat surgery vs. other options; κ = 0.198 [95% confidence interval: 0.133-0.276]). Country of practice, years' experience, and training background did not change results. Disagreement and clinical uncertainty were more pronounced within clinicians with (κ = 0.167 [0.055-0.314]) than clinicians without neuro-oncology fellowship training (κ = 0.601 [0.556-0.646]). A majority (51%) of responders were willing to include the patient in a randomized trial comparing repeat surgery with nonsurgical alternatives in 26/37 (69%) of cases. Conclusion:There is sufficient uncertainty and equipoise regarding the question of reoperation for patients with recurrent glioblastoma to support the need for a randomized controlled trial.

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Clinical Uncertainty and Equipoise in the Management of Recurrent Glioblastoma

Patel¹,

Au²,

Davis³

et al. 2021

American Journal of Clinical Oncology

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“…This is the fallacy of wrong-axis comparisons that we have explained elsewhere, a fallacy which biases all clinical experiences outside RCTs [ 32 ]. Third, such case-by-case decisions under uncertainty are unrepeatable, even at the individual clinician level, as we have previously shown for most care trial dilemmas [ 59 ]. Unreliable clinical decisions directly lead to forever-unverifiable care.…”

Section: Personal Care Equipoise and Feasibilitymentioning

confidence: 99%

Practicing outcome-based medical care using pragmatic care trials

Darsaut

Raymond

2020

Trials

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The current separation between medical research and care is an obstacle to essential aspects of good medical practice: the verification that care interventions actually deliver the good outcomes they promise, and the use of scientific methods to optimize care under uncertainty. Pragmatic care trials have been designed to address these problems. Care trials are all-inclusive randomized trials integrated into care. Every item of trial design is selected in the best medical interest of participating patients. Care trials can eventually show what constitutes good medical practice based on patient outcomes. In the meantime, care trials give clinicians and patients the scientific methods necessary for optimization of medical care when no one really knows what to do. We report the progress of 9 randomized care trials that were used to guide the endovascular or surgical management of 1212 patients with acute stroke, intracranial aneurysms, and arteriovenous malformations in a single center in an elective or acute care context. Care trials were used to address long-standing dilemmas regarding rival medical, surgical, or endovascular management options or to offer innovative instead of standard treatments. The trial methodology, by replacing unrepeatable treatment decisions by 1:1 randomized allocation whenever reliable knowledge was not available, had an immediate impact, transforming unverifiable dogmatic medical practice into verifiable outcome-based medical care. We believe the approach is applicable to all medical or surgical domains, but widespread adoption may require the revision of many currently prevalent views regarding the role of research in clinical practice.

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Experience using pragmatic care trials to guide neurovascular practice under uncertainty

Darsaut

Raymond²

2020

Neurochirurgie

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Measuring clinical uncertainty as a preliminary step to randomized controlled trials

Cited by 6 publications

References 9 publications

Clinical Uncertainty and Equipoise in the Management of Recurrent Glioblastoma

Clinical Uncertainty and Equipoise in the Management of Recurrent Glioblastoma

Practicing outcome-based medical care using pragmatic care trials

Experience using pragmatic care trials to guide neurovascular practice under uncertainty

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