scholarly journals Statistical analysis plan for the COMPARE trial: a 3-arm randomised controlled trial comparing the effectiveness of Constraint-induced Aphasia Therapy Plus and Multi-modality Aphasia Therapy to usual care in chronic post-stroke aphasia (COMPARE)

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Miranda L. Rose ◽  
Tapan Rai ◽  
David Copland ◽  
Lyndsey Nickels ◽  
Leanne Togher ◽  
...  
Keyword(s):  
Statistical Analysis ◽  
Usual Care ◽  
Relative Effectiveness ◽  
Random Effect ◽  
Statistical Analysis Plan ◽  
Trial Registration ◽  
Post Intervention ◽  
Post Stroke ◽  
Aphasia Therapy

Abstract Background While high-quality meta-analyses have confirmed the effectiveness of aphasia therapy after stroke, there is limited evidence for the comparative effectiveness of different aphasia interventions. Two commonly used interventions, Constraint-induced Aphasia Therapy Plus (CIAT Plus) and Multi-modality Aphasia Therapy (M-MAT), are hypothesised to rely on diverse underlying neural mechanisms for recovery and may be differentially responsive to aphasia severity. COMPARE is a prospective randomised open-blinded end-point trial designed to determine whether, in people with chronic post-stroke aphasia living in the community, CIAT Plus and M-MAT provide greater therapeutic benefit compared to usual care, are differentially effective according to aphasia severity, and are cost-effective. This paper details the statistical analysis plan for the COMPARE trial developed prior to data analysis. Methods Participants (n = 216) are randomised to one of three arms, CIAT Plus, M-MAT or usual care, and undertake therapy with a study trained speech pathologist in groups of three participants stratified by aphasia severity. Therapy occurs for 3 h blocks per day for 10 days across 2 weeks. The primary clinical outcome is aphasia severity as measured by the Western Aphasia Battery-Revised Aphasia Quotient (WAB-R-AQ) immediately post intervention. Secondary outcomes include WAB-R-AQ at 12-week follow-up, and functional communication, discourse efficiency, multimodal communication, and health-related quality of life immediately post intervention and at 12-week follow-up. Results Linear mixed models (LMMs) will be used to analyse differences between M-MAT and UC, and CIAT-Plus and UC on each outcome measure immediately and at 12 weeks post-intervention. The LMM for WAB-R-AQ will assess the differences in efficacy between M-MAT and CIAT-Plus. All analyses will control for baseline aphasia severity (fixed effect) and for the clustering effect of treatment groups (random effect). Discussion This trial will provide relative effectiveness data for two common interventions for people with chronic post-stroke aphasia, and highlight possible differential effects based on aphasia severity. Together with the health economic analysis data, the results will enable more informed personalised prescription for aphasia therapy after stroke. Trial registration Australian New Zealand Clinical Trials Registry: ACTRN 12615000618550. Registered on 15 June 2016

scholarly journals Statistical analysis plan for management of hypertension and multiple risk factors to enhance cardiovascular health in Singapore: the SingHypertension pragmatic cluster randomized controlled trial

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
John C. Allen ◽  
◽  
Benjamin Halaand ◽  
Rupesh M. Shirore ◽  
Tazeen H. Jafar
Keyword(s):  
Risk Factors ◽  
Primary Care ◽  
Statistical Analysis ◽  
Usual Care ◽  
Statistical Analysis Plan ◽  
Activity Level ◽  
Uncontrolled Hypertension ◽  
Primary Care Clinics ◽  
Cluster Randomized

Abstract Introduction Cardiovascular disease remains the leading cause of death in Singapore. Uncontrolled hypertension confers the highest attributable risk of CVD and remains a significant public health issue with sub-optimal blood pressure (BP) control rates. The aim of the trial is to evaluate the effectiveness and cost-effectiveness of a multicomponent intervention (MCI) versus usual care on lowering BP among adults with uncontrolled hypertension visiting primary care clinics in Singapore. This article describes the statistical analysis plan for the primary and secondary objectives related to intervention effectiveness. Methods The study is a cluster randomized trial enrolling 1000 participants with uncontrolled hypertension aged ≥ 40 years from eight primary care clinics in Singapore. The unit of randomization is the clinic, with eight clusters (clinics) randomized in a 1:1 ratio to either MCI or usual care. All participants will be assessed at baseline, 12 months, and 24 months with measurements of systolic and diastolic BP, antihypertensive and statin medication use, medication adherence, physical activity level, anthropometric parameters, smoking status, and dietary habits. The primary objective of this study is to assess the effectiveness of MCI versus usual care on mean SBP at the 2-year follow-up. The primary outcome is SBP at 24 months. SBP at baseline, 12, and 24 months will be modeled at the subject level using a likelihood-based, linear mixed-effects model repeated measures (MMRM) analysis with treatment group and follow-up as fixed effects, random cluster (clinic) effects, Gaussian error distribution, and adjustment to degrees of freedom using the Satterthwaite approximation. Secondary outcomes will be analyzed using a similar modeling approach incorporating generalized techniques appropriate for the type of outcome. Discussion The trial will allow us to determine whether the MCI has an impact on BP and cardiovascular risk factors over a 2-year follow-up period and inform recommendations for health planners in scaling up these strategies for the benefit of society at large. A pre-specified and pre-published statistical analysis plan mitigates reporting bias and data driven approaches. Trial registration ClinicalTrials.gov NCT02972619. Registered on 23 November 2016.

scholarly journals Statistical analysis plan (SAP) for the Very Early Rehabilitation in Speech (VERSE) after stroke trial: an international 3-arm clinical trial to determine the effectiveness of early, intensive, prescribed, direct aphasia therapy

2018 ◽  
Vol 13 (8) ◽  
pp. 863-880 ◽  
Author(s):  
Erin Godecke ◽  
Tapan Rai ◽  
Dominique A Cadilhac ◽  
Elizabeth Armstrong ◽  
Sandy Middleton ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Statistical Analysis ◽  
Statistical Analysis Plan ◽  
Steering Committee ◽  
Aphasia Therapy ◽  
Detailed Statistical Analysis ◽  
Registration Number ◽  
Clinical Trials Registry ◽  
Potential Trial ◽  
Stroke Trial

Background Limited evidence exists to support very early intensive aphasia rehabilitation after stroke. VERSE is a PROBE trial designed to determine whether two types of intensive aphasia therapy, beginning within 14 days of acute stroke, provide greater therapeutic and cost-effectiveness than usual care. Objective To publish the detailed statistical analysis plan for the VERSE trial prior to unblinding. This statistical analysis plan was based on the published and registered VERSE trial protocol and was developed by the blinded steering committee and management team, led by the trial statistician. This plan was developed using outcome measures and trial data collection forms. Results The VERSE statistical analysis plan is consistent with reporting standards for clinical trials and provides for clear and open reporting. Conclusions Publication of a statistical analysis plan serves to reduce potential trial reporting bias and outlines transparent pre-specified analyses. Australian New Zealand Clinical Trials Registry (ANZCTR) Registration number: ACTRN12613000776707; Universal Trial Number (UTN) is U1111-1145-4130.

scholarly journals Is there a causal relationship between acute stage sensorimotor cortex activity and the development of chronic low back pain? a protocol and statistical analysis plan

BMJ Open ◽  
2019 ◽  
Vol 9 (12) ◽  
pp. e035792
Author(s):  
Luke Jenkins ◽  
Wei-ju Chang ◽  
Valentina Buscemi ◽  
Chelsea Cunningham ◽  
Aidan Cashin ◽  
...  
Keyword(s):  
Low Back Pain ◽  
Back Pain ◽  
Statistical Analysis ◽  
Sensorimotor Cortex ◽  
Chronic Low Back Pain ◽  
Directed Acyclic Graph ◽  
Causal Effect ◽  
Statistical Analysis Plan ◽  
Low Back

IntroductionWhy some people develop chronic pain following an acute episode of low back pain is unknown. Recent cross-sectional studies have suggested a relationship between aberrant sensorimotor cortex activity and pain persistence. The UPWaRD (Understanding persistent Pain Where it ResiDes) cohort study is the first prospective, longitudinal investigation of sensorimotor cortex activity in low back pain. This paper describes the development of a causal model and statistical analysis plan for investigating the causal effect of sensorimotor cortex activity on the development of chronic low back pain.Methods and analysisSensorimotor cortex activity was assessed within 6 weeks of low back pain onset using somatosensory evoked potentials and transcranial magnetic stimulation mapping techniques. Chronic low back pain is defined as ongoing pain (Numerical Rating score ≥1) or disability (Roland Morris Disability Questionnaire score ≥3) at 6 months follow-up. Variables that could confound the relationship between sensorimotor cortex activity and chronic low back pain were identified using a directed acyclic graph and content expertise was used to specify known causal paths. The statistical model was developed ‘a priori’ to control for confounding variables identified in the directed acyclic graph, allowing an unbiased estimate of the causal effect of sensorimotor activity in acute low back pain on the development of chronic pain. The statistical analysis plan was finalised prior to follow-up of all participants and initiation of analysis.Ethics and disseminationEthical approval has been obtained from Western Sydney University Human Research Ethics Committee (H10465) and from Neuroscience Research Australia (SSA: 16/002). Dissemination will occur through presentations at national and international conferences and publications in international peer-reviewed journals.Trial registration numberACTRN12619000002189 (retrospectively registered)

scholarly journals A physical activity coaching intervention can increase and maintain physical activity and health-related outcomes in adult ambulatory care patients in a regional hospital: the Healthy4U-2 randomised controlled trial

2020 ◽  
Author(s):  
Stephen Barrett ◽  
Steve Begg ◽  
Paul O'Halloran ◽  
Michael Kingsley
Keyword(s):  
Physical Activity ◽  
Body Mass ◽  
Intervention Group ◽  
Trial Registration ◽  
Post Intervention ◽  
Coaching Intervention ◽  
Health Related ◽  
Active Adults

Abstract Background: The Healthy 4U-2 study sought to evaluate the effect of a twelve-week, physical activity (PA) coaching intervention for changes and maintenance in PA, anthropometrics and health-related outcomes in adults presenting to an ambulatory hospital clinic. Methods: One hundred and twenty insufficiently active adults were recruited from an ambulatory hospital clinic and randomised to an intervention group that received an education session and five 20-minute telephone sessions of PA coaching, or to a control group that received the education session only. ActiGraph GT3X accelerometers were used to measure moderate-to-vigorous physical activity (MVPA) at baseline, post-intervention (3-months) and follow-up (9-months). Secondary outcome measures (anthropometrics, PA self-efficacy, health-related and quality of life) were also assessed at the three time points. Results: At baseline, the mean age and body mass index of participants were 53 ± 8 years and 31 ± 4 kg/m 2 , respectively. Relative to control, the intervention group increased objectively measured MVPA at post-intervention (p<0.001) and 9 months follow-up (p<0.001). At the 9-month follow-up the intervention group completed 22 min/day of MVPA (95% CI: 20 to 25 min/day), which is sufficient to meet the recommended PA guidelines. The intervention group exhibited beneficial changes in body mass (p<0.001), waist circumference (p<0.001), body mass index (p<0.001), PA self-efficacy (p<0.001), and health-related quality of life (p<0.001) at the 9-month follow-up. Conclusions: This study demonstrates that a low contact PA coaching intervention results in beneficial changes in PA, anthropometrics and health-related outcomes in insufficiently active adults presenting to an ambulatory care clinic. The significant beneficial changes were measured at post-intervention and the 9-month follow-up, demonstrating a maintenance effect of the intervention. Trial registration: Prospectively registered on the Australian and New Zealand Clinical Trials Registry (ANZCTR). Trial registration number: ACTRN12619000036112. http://anzctr.org.au/Trial/Registration/TrialReview.aspx?id=376318 Keywords Physical activity; Exercise motivation; Accelerometry; Public health

scholarly journals PRECISE — pregabalin in addition to usual care: statistical analysis plan

Trials ◽  
2016 ◽  
Vol 17 (1) ◽  
Author(s):  
Stephanie Mathieson ◽  
Laurent Billot ◽  
Christopher G. Maher ◽  
Andrew J. McLachlan ◽  
Jane Latimer ◽  
...  
Keyword(s):  
Statistical Analysis ◽  
Usual Care ◽  
Statistical Analysis Plan

scholarly journals A physical activity coaching intervention can improve and maintain physical activity and health-related outcomes in adult ambulatory hospital patients: the Healthy4U-2 randomised controlled trial

2020 ◽  
Vol 17 (1) ◽  
Author(s):  
Stephen Barrett ◽  
Stephen Begg ◽  
Paul O’Halloran ◽  
Michael Kingsley
Keyword(s):  
Physical Activity ◽  
Body Mass ◽  
Intervention Group ◽  
Trial Registration ◽  
Post Intervention ◽  
Coaching Intervention ◽  
Related Quality ◽  
Health Related ◽  
Active Adults

Abstract Background The Healthy 4 U-2 study sought to evaluate the effect of a twelve-week, physical activity (PA) coaching intervention for changes and maintenance in PA, anthropometrics and health-related outcomes in adults presenting to an ambulatory hospital clinic. Methods One hundred and twenty insufficiently active adults were recruited from an ambulatory hospital clinic and randomised to an intervention group that received an education session and five 20-min telephone sessions of PA coaching, or to a control group that received the education session only. ActiGraph GT3X accelerometers were used to measure moderate-to-vigorous physical activity (MVPA) at baseline, post-intervention (3-months) and follow-up (9-months). Secondary outcome measures (anthropometrics, PA self-efficacy, and health-related quality of life) were also assessed at the three time points. Results At baseline, the mean age and body mass index of participants were 53 ± 8 years and 31 ± 4 kg/m2, respectively. Relative to control, the intervention group increased objectively measured MVPA at post-intervention (p < 0.001) and 9 months follow-up (p < 0.001). At the 9-month follow-up the intervention group completed 22 min/day of MVPA (95% CI: 20 to 25 min/day), which is sufficient to meet the recommended PA guidelines. The intervention group exhibited beneficial changes in body mass (p < 0.001), waist circumference (p < 0.001), body mass index (p < 0.001), PA self-efficacy (p < 0.001), and health-related quality of life (p < 0.001) at the 9-month follow-up. Conclusions This study demonstrates that a low contact PA coaching intervention results in beneficial changes in PA, anthropometrics and health-related outcomes in insufficiently active adults presenting to an ambulatory care clinic. The significant beneficial changes were measured at post-intervention and the 9-month follow-up, demonstrating a maintenance effect of the intervention. Trial registration Prospectively registered on the Australian and New Zealand Clinical Trials Registry (ANZCTR, Trial registration number: ACTRN12619000036112.

scholarly journals The Benefits and Risks of Iron interventionS in Children (BRISC) trial: Statistical analysis plan

F1000Research ◽  
2020 ◽  
Vol 9 ◽  
pp. 427 ◽  
Author(s):  
Sabine Braat ◽  
Leila Larson ◽  
Julie A. Simpson ◽  
Mohammed Imrul Hasan ◽  
Jena Derakhshani Hamadani ◽  
...  
Keyword(s):  
Statistical Analysis ◽  
Statistical Analysis Plan ◽  
Steering Committee ◽  
Trial Steering Committee ◽  
Statistical Analyses ◽  
World Health ◽  
Trial Management ◽  
Post Intervention ◽  
Health Organization ◽  
The Impact

Background: The Benefits and Risks of Iron interventionS in Children (BRISC) trial will evaluate the impact of universal supplementation with iron supplements or iron-containing multiple micronutrient powders (MNPs) compared with placebo given for 3 months on child development, growth, morbidity, laboratory indices of anaemia, iron deficiency, and inflammation at end of intervention and after a further 9 months post intervention in children aged 8 months living in rural Bangladesh. This paper describes the statistical analysis plan. Methods: BRISC is a multi-site, three-arm, double-dummy blinded, parallel group, randomised control superiority trial in 3300 children. The statistical analysis plan was developed by the trial statistician in consultation with the trial steering committee and trial management committee based on the protocol, data collection forms, and study outcomes available in the blinded study database.   Conclusion: This detailed statistical analysis plan published prior to unblinding the allocated treatments will support the statistical analyses and reporting of the BRISC trial to be undertaken after unblinding. It allows for transparency as well as reproducibility of statistical analyses and reporting. Registration: Australian New Zealand Clinical Trials Registry ACTRN12617000660381 (registered on 8 May 2017); World Health Organization Universal Trial Number U1111-1196-1125.

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