Stopping randomized trials early for benefit: a protocol of the Study Of Trial Policy Of Interim Truncation-2 (STOPIT-2)

Briel, Matthias; Lane, Melanie A.; Montori, Víctor M.; Bassler, Dirk; Glasziou, Paul; Málaga, Germán; Akl, Elie A.; Ferreira‐González, Ignacio; Alonso‐Coello, Pablo; Urrútia, Gerard; Kunz, Regina; Culebro, Carolina Ruiz; Silva, Suzana Alves da; Flynn, David N.; Elamin, Mohamed B.; Strahm, Brigitte; Murad, M. Hassan; Djulbegoviĉ, Benjamin; Adhikari, Neill K. J.; Mills, Edward J.; Gwadry-Sridhar, Femida; Kirpalani, Haresh; Soares, Heloisa P.; Elnour, Nisrin O. Abu; You, John J.; Karanicolas, Paul J.; Bucher, Heiner C.; Lampropulos, Julianna F.; Nordmann, Alain; Burns, Karen E. A.; Mulla, Sohail; Raatz, Heike; Sood, Amit; Kaur, Jagdeep; Bankhead, Clare; Mullan, Rebecca J.; Nerenberg, Kara; Vandvik, Per Olav; Coto-Yglesias, Fernando; Tuche, Fabio; Chrispim, Pedro Paulo Magalhães; Cook, Deborah J.; Lutz, Kristina; Ribic, Christine; Vale, Noah; Erwin, Patricia J.; Perera, Rafael; Zhou, Qi; Heels‐Ansdell, Diane; Ramsay, Tim; Walter, Stephen D.; Guyatt, Gordon

doi:10.1186/1745-6215-10-49

Cited by 28 publications

(14 citation statements)

References 25 publications

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“…The approach to interim analyses is guided by a desire to avoid spuriously inflated estimates of treatment effect. 42 A single interim analysis will be performed when 60% of the planned patient-years of follow-up have been accrued. The data analyst will present the results of these analyses to our independent Data Monitoring Committee.…”

Section: Methods and Analysismentioning

confidence: 99%

Hip fracture evaluation with alternatives of total hip arthroplasty versus hemiarthroplasty (HEALTH): protocol for a multicentre randomised trial

et al. 2015

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IntroductionHip fractures are a leading cause of mortality and disability worldwide, and the number of hip fractures is expected to rise to over 6 million per year by 2050. The optimal approach for the surgical management of displaced femoral neck fractures remains unknown. Current evidence suggests the use of arthroplasty; however, there is lack of evidence regarding whether patients with displaced femoral neck fractures experience better outcomes with total hip arthroplasty (THA) or hemiarthroplasty (HA). The HEALTH trial compares outcomes following THA versus HA in patients 50 years of age or older with displaced femoral neck fractures.Methods and analysisHEALTH is a multicentre, randomised controlled trial where 1434 patients, 50 years of age or older, with displaced femoral neck fractures from international sites are randomised to receive either THA or HA. Exclusion criteria include associated major injuries of the lower extremity, hip infection(s) and a history of frank dementia. The primary outcome is unplanned secondary procedures and the secondary outcomes include functional outcomes, patient quality of life, mortality and hip-related complications—both within 2 years of the initial surgery. We are using minimisation to ensure balance between intervention groups for the following factors: age, prefracture living, prefracture functional status, American Society for Anesthesiologists (ASA) Class and centre number. Data analysts and the HEALTH Steering Committee are blinded to the surgical allocation throughout the trial. Outcome analysis will be performed using a χ2 test (or Fisher's exact test) and Cox proportional hazards modelling estimate. All results will be presented with 95% CIs.Ethics and disseminationThe HEALTH trial has received local and McMaster University Research Ethics Board (REB) approval (REB#: 06-151).ResultsOutcomes from the primary manuscript will be disseminated through publications in academic journals and presentations at relevant orthopaedic conferences. We will communicate trial results to all participating sites. Participating sites will communicate results with patients who have indicated an interest in knowing the results.Trial registration numberThe HEALTH trial is registered with clinicaltrials.gov (NCT00556842).

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Section: Methods and Analysismentioning

confidence: 99%

Hip fracture evaluation with alternatives of total hip arthroplasty versus hemiarthroplasty (HEALTH): protocol for a multicentre randomised trial

et al. 2015

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“…The decision to stop trials early is controversial; a systematic review of trials stopped early for benefit reported implausibly large treatment effects, particularly when the number of events was small (Montori et al., 2005). An extension of this review is ongoing to further understand the extent to which trials stopped early may exaggerate treatment effects (Briel et al., 2009).…”

Section: Methodsmentioning

confidence: 99%

The REFLECT Statement: Reporting Guidelines for Randomized Controlled Trials in Livestock and Food Safety: Explanation and Elaboration

Sargeant¹,

O’Connor²,

Gardner³

et al. 2010

Zoonoses and Public Health

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Concerns about the completeness and accuracy of reporting of randomized clinical trials (RCTs) and the impact of poor reporting on decision making have been documented in the medical field over the past several decades. Experience from RCTs in human medicine would suggest that failure to report critical trial features can be associated with biased estimated effect measures, and there is evidence to suggest that similar biases occur in RCTs conducted in livestock populations. In response to these concerns, standardized guidelines for reporting RCTs were developed and implemented in human medicine. The Consolidated Standards of Reporting Trials (CONSORT) statement was first published in 1996, with a revised edition published in 2001. The CONSORT statement consists of a 22‐item checklist for reporting a RCT and a flow diagram to follow the number of participants at each stage of a trial. An explanation and elaboration document not only defines and discusses the importance of each of the items, but also provides examples of how this information could be supplied in a publication. Differences between human and livestock populations necessitate modifications to the CONSORT statement to maximize its usefulness for RCTs involving livestock. These have been addressed in an extension of the CONSORT statement titled the REFLECT statement: Methods and processes of creating reporting guidelines for randomized control trials for livestock and food safety. The modifications made for livestock trials specifically addressed the common use of group housing and group allocation to intervention in livestock studies; the use of deliberate challenge models in some trials and the common use of non‐clinical outcomes, such as contamination with a foodborne pathogen. In addition, the REFLECT statement for RCTs in livestock populations proposed specific terms or further clarified terms as they pertained to livestock studies.

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“…If a statistically significant subgroup effect is found, we will further explore the impact of the subgroup on the secondary outcomes. No interim analyses are planned due to our desire to avoid spuriously inflated estimates of treatment effect [ 29 , 30 ]. The Data Safety and Monitoring Committee (DSMC) meet regularly to monitor the study data for safety.…”

Section: Discussionmentioning

confidence: 99%

Femoroacetabular Impingement Randomised controlled Trial (FIRST) - a multi-centre randomized controlled trial comparing arthroscopic lavage and arthroscopic osteochondroplasty on patient important outcomes and quality of life in the treatment of young adult (18–50 years) femoroacetabular impingement: a statistical analysis plan

Simunovic

Heels‐Ansdell

Thabane

et al. 2018

Trials

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BackgroundThe research objectives of the Femoroacetabular Impingement Randomised controlled Trial (FIRST) are to assess whether surgical correction of the hip impingement morphology (arthroscopic osteochondroplasty) with or without labral repair, in adults aged 18–50 years diagnosed with non-arthritic femoroacetabular impingement (FAI), provides decreased pain and improved health-related quality of life at 12 months compared to arthroscopic lavage of the hip joint. This article describes the statistical analysis plan for the FIRST trial.Methods/designFIRST is an ongoing multi-centre, blinded randomised controlled trial of 220 patients who have been diagnosed with FAI and are optimized for surgical intervention. This article describes the overall analysis principles, including how participants will be included in each analysis, the presentation of the results, adjustments for covariates, the primary and secondary outcomes and their respective analyses. In addition, we will present the planned sensitivity and subgroup analyses.DiscussionOur rationale for FIRST is based upon (1) an epidemic of FAI surgery with resultant increased healthcare costs over that last decade, (2) worldwide disparity in perceptions about its utility, and (3) consensus that definitive evidence for or against surgical approaches is lacking.Trial registrationClinicalTrials.gov, NCT01623843. Registered on 20 June 2012.

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Stopping randomized trials early for benefit: a protocol of the Study Of Trial Policy Of Interim Truncation-2 (STOPIT-2)

Cited by 28 publications

References 25 publications

Hip fracture evaluation with alternatives of total hip arthroplasty versus hemiarthroplasty (HEALTH): protocol for a multicentre randomised trial

Hip fracture evaluation with alternatives of total hip arthroplasty versus hemiarthroplasty (HEALTH): protocol for a multicentre randomised trial

The REFLECT Statement: Reporting Guidelines for Randomized Controlled Trials in Livestock and Food Safety: Explanation and Elaboration

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