scholarly journals A statistical framework for quantifying clinical equipoise for individual cases during randomized controlled surgical trials

Trials ◽  
2011 ◽  
Vol 12 (1) ◽  
Author(s):  
Nicholas R Parsons ◽  
Yuri Kulikov ◽  
Alan Girling ◽  
Damian Griffin
Keyword(s):  
Clinical Equipoise ◽  
Surgical Trials ◽  
Randomized Controlled ◽  
Statistical Framework

Challenges of Randomized Controlled Surgical Trials

2010 ◽  
Vol 41 (2) ◽  
pp. 145-155 ◽  
Author(s):  
Angela J. Campbell ◽  
Anita Bagley ◽  
Ann Van Heest ◽  
Michelle A. James
Keyword(s):  
Surgical Trials ◽  
Randomized Controlled

scholarly journals Adequacy of risk of bias assessment in surgical vs non-surgical trials in Cochrane reviews: a methodological study

2020 ◽  
Vol 20 (1) ◽  
Author(s):  
Ognjen Barcot ◽  
Matija Boric ◽  
Svjetlana Dosenovic ◽  
Marija Cavar ◽  
Antonia Jelicic Kadic ◽  
...  
Keyword(s):  
Systematic Reviews ◽  
Allocation Concealment ◽  
Risk Of Bias ◽  
Methodological Study ◽  
Bias Assessment ◽  
Surgical Trials ◽  
Surgical Interventions ◽  
Randomized Controlled ◽  
Cochrane Reviews ◽  
The Difference

Abstract Background Bias in randomized controlled trials (RCTs) can lead to underestimation or overestimation of the true effects of interventions. Surgical RCTs may suffer from the risk of bias (RoB) that is avoidable in trials of other interventions, and vice versa. We aimed to compare the adequacy of RoB assessments in surgical versus non-surgical RCTs included in Cochrane reviews and to assess the most common differences in those RoB assessments. Due to specificities of surgical trials, i.e. difficulties associated with blinding of surgical interventions, we hypothesized that assessments of surgical trials may be more adequate, compared to RCTs of non-surgical interventions. Methods This was a methodological study, analyzing methods of published Cochrane systematic reviews. Data were extracted from RoB tables in Cochrane reviews (judgments and accompanying explanatory comment) for the following four RoB domains used in the 2011 Cochrane RoB tool: randomization, allocation concealment, blinding of participants and personnel, and blinding of outcome assessors. We defined adequate assessments as those that were in line with instructions from the Cochrane Handbook for Systematic Reviews of Interventions. The prevalence of adequate assessments was compared in surgical versus non-surgical trials. The most common differences in both groups of reviews were presented. Results In 729 analyzed Cochrane reviews, there were 10,537 included trials. The prevalence of adequate RoB judgments made by Cochrane authors ranged from 87.9, 95%CI (87.3 to 88.6%) for randomization to 70.7, 95%CI (69.8 to 71.5%) for blinding of participants and personnel. For all analyzed RoB domains, the prevalence of adequate RoB domains was higher in surgical trials than in non-surgical trials. For two RoB domains assessing blinding, this difference between surgical and non-surgical trials was statistically significant (P < 0.001), while the difference was not significant for the RoB domain regarding randomization (P = 0.124) and allocation concealment (P = 0.039, β < 0.8). Conclusions RoB judgments were more in line with instructions from the Cochrane Handbook when Cochrane reviews assessed surgical trials, compared to those that analyzed non-surgical interventions. However, further steps are warranted to scrutinize RoB assessment in trials of both surgical and non-surgical interventions.

scholarly journals Equipoise and the Ethics of the Canadian Lung Volume Reduction Surgery Trial study: Should There Be a Randomized, Controlled Trial to Evaluate Lung Volume Reduction Surgery?

2000 ◽  
Vol 7 (4) ◽  
pp. 329-332 ◽  
Author(s):  
John D Miller ◽  
Michael D Coughlin ◽  
Lori Edey ◽  
Patricia Miller ◽  
Yasmin Sivji
Keyword(s):  
Randomized Controlled Trial ◽  
Lung Volume ◽  
Controlled Trial ◽  
Volume Reduction ◽  
Three Dimensions ◽  
Clinical Equipoise ◽  
Lung Volume Reduction Surgery ◽  
Lung Volume Reduction ◽  
Randomized Controlled ◽  
Surgery Trial

The physical improvement is so great following lung volume reduction surgery that there is growing opinion that a randomized, controlled trial is unnecessary. A randomized, controlled trial, it is argued, would deprive those patients randomly assigned to the nonsurgical treatment arm the 'benefit' of lung volume reduction surgery. Entering a trial in which one arm leads to a surgical intervention and the other to best medical management also poses a variety of ethical difficulties. If one is to be offered surgery, there must be perceived benefit because the physician has an obligation to offer the best possible treatment for his or her patient. If a patient agrees to have surgery, the expectation is that surgery would help. Thus, a patient randomly assigned to the medical arm of a trial may easily believe that he or she is being deprived of surgery that may help them. This paper illustrates this dilemma using the Canadian Lung Volume Reduction Surgery Trial. The authors discuss the concept of 'equipoise' in three dimensions, adding community equipoise to theoretical equipoise and clinical equipoise earlier described by Freedman. The paper concludes that the Canadian Lung Volume Reduction Surgery Trial needs to continue because of the clinical equipoise that drives it.

Clinical equipoise and systematic reviews of randomized controlled trials

2015 ◽  
Vol 145 (11) ◽  
pp. 496-498
Author(s):  
Ferrán Catalá-López ◽  
Diana González-Bermejo ◽  
César de la Fuente Honrubia ◽  
Diego Macías Saint-Gerons
Keyword(s):  
Randomized Controlled Trials ◽  
Systematic Reviews ◽  
Controlled Trials ◽  
Clinical Equipoise ◽  
Randomized Controlled

The Welfare of Children, Research Ethics, and the Bucharest Early Intervention Project

2018 ◽  
pp. 145-154
Author(s):  
Maria G. Master ◽  
Joseph J. Fins
Keyword(s):  
Early Intervention ◽  
Ethical Issues ◽  
Conflicts Of Interest ◽  
Controlled Trial ◽  
Institutional Care ◽  
Careful Analysis ◽  
Clinical Equipoise ◽  
Randomized Controlled ◽  
Human Goodness ◽  
Early Intervention Project

Ethical principals demand that science foster human goodness and flourishing—serving as a tool to help, not harm, humanity. This chapter considers as a case study the Bucharest Early Intervention Project (BEIP), a randomized controlled trial comparing the effects of foster care as an alternative to institutional care for young children in Bucharest, Romania. The study results suggested that early institutionalization leads to profound deficits in many domains. The ethical issues triggered by these experiments span the domains of randomization to harm, clinical equipoise, standard of care, researcher ambivalence, duty to rescue, political cooptation and conflicts of interest, and logicality. The alleged methodological rigor of the randomized controlled BEIP has a seductive internal consistency, but careful analysis reveals that gloss distracted the scientific community from our fundamental ethical obligation to provide authentic witness to, and compassionate care for, the most vulnerable among us.

scholarly journals Demystifying the Benefits and Harms of Anticoagulation for Atrial Fibrillation in Chronic Kidney Disease

2018 ◽  
Vol 14 (1) ◽  
pp. 125-136 ◽  
Author(s):  
Katherine G. Garlo ◽  
David J.R. Steele ◽  
Sagar U. Nigwekar ◽  
Kevin E. Chan
Keyword(s):  
Atrial Fibrillation ◽  
Controlled Trial ◽  
Clinical Care ◽  
Oral Anticoagulants ◽  
Contemporary Literature ◽  
Clinical Equipoise ◽  
Pharmacokinetic Studies ◽  
Randomized Controlled ◽  
Direct Acting

Patients with CKD represent a vulnerable population where the risks of atrial fibrillation, ischemic stroke, and bleeding are all heightened. Although large randomized, controlled trials in the general population clearly demonstrate that the benefits of warfarin and direct-acting oral anticoagulants outweigh the risks of bleeding, no such studies have been conducted in patients when their creatinine clearance falls below 25–30 ml/min. Without randomized, controlled trial data, the role of anticoagulation in patients with CKD with atrial fibrillation remains unclear and our practice is informed by a growing body of imperfect literature such as observational and pharmacokinetic studies. This article aims to present a contemporary literature review of the benefits versus harms of anticoagulation in atrial fibrillation for patients with CKD stages 3, 4, 5, and 5 on dialysis. Although unanswered questions and areas of clinical equipoise remain, this piece serves to assist physicians in interpreting the complex body of literature and applying it to their clinical care.

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