scholarly journals Noninterventional follow‐up vs fluid bolus in RESPONSE to oliguria—The RESPONSE trial protocol and statistical analysis plan

2020 ◽  
Vol 64 (8) ◽  
pp. 1210-1217
Author(s):  
Nina Inkinen ◽  
Tuomas Selander ◽  
Ville Pettilä ◽  
Miia Valkonen ◽  
Minna Bäcklund ◽  
...  
Keyword(s):  
Statistical Analysis ◽  
Statistical Analysis Plan ◽  
Trial Protocol ◽  
Fluid Bolus ◽  
Response Trial

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 Low‐dose hydrocortisone in patients with COVID‐19 and severe hypoxia (COVID STEROID) trial—Protocol and statistical analysis plan

2020 ◽  
Vol 64 (9) ◽  
pp. 1365-1375 ◽  
Author(s):  
Marie Warrer Petersen ◽  
Tine Sylvest Meyhoff ◽  
Marie Helleberg ◽  
Maj‐Brit Nørregaard Kjær ◽  
Anders Granholm ◽  
...  
Keyword(s):  
Statistical Analysis ◽  
Low Dose ◽  
Statistical Analysis Plan ◽  
Severe Hypoxia ◽  
Trial Protocol

scholarly journals The effectiveness and safety of antifibrinolytics in patients with acute intracranial haemorrhage: statistical analysis plan for an individual patient data meta-analysis

2017 ◽  
Vol 2 ◽  
pp. 120 ◽  
Author(s):  
Katharine Ker ◽  
David Prieto-Merino ◽  
Nikola Sprigg ◽  
Abda Mahmood ◽  
Philip Bath ◽  
...  
Keyword(s):  
Statistical Analysis ◽  
Intracranial Haemorrhage ◽  
Individual Patient Data ◽  
Meta Analysis ◽  
Statistical Analysis Plan ◽  
Patient Data ◽  
Time To Treatment ◽  
Logistic Regression Models ◽  
Secondary Outcomes

Introduction: The Antifibrinolytic Trialists Collaboration aims to increase knowledge about the effectiveness and safety of antifibrinolytic treatment by conducting individual patient data (IPD) meta-analyses of randomised trials. This article presents the statistical analysis plan for an IPD meta-analysis of the effects of antifibrinolytics for acute intracranial haemorrhage. Methods: The protocol for the IPD meta-analysis has been registered with PROSPERO (CRD42016052155). We will conduct an individual patient data meta-analysis of randomised controlled trials with 1000 patients or more assessing the effects of antifibrinolytics in acute intracranial haemorrhage. We will assess the effect on two co-primary outcomes: 1) death in hospital at end of trial follow-up, and 2) death in hospital or dependency at end of trial follow-up. The co-primary outcomes will be limited to patients treated within three hours of injury or stroke onset. We will report treatment effects using odds ratios and 95% confidence intervals. We use logistic regression models to examine how the effect of antifibrinolytics vary by time to treatment, severity of intracranial bleeding, and age. We will also examine the effect of antifibrinolytics on secondary outcomes including death, dependency, vascular occlusive events, seizures, and neurological outcomes. Secondary outcomes will be assessed in all patients irrespective of time of treatment. All analyses will be conducted on an intention-to-treat basis. Conclusions: This IPD meta-analysis will examine important clinical questions about the effects of antifibrinolytic treatment in patients with intracranial haemorrhage that cannot be answered using aggregate data. With IPD we can examine how effects vary by time to treatment, bleeding severity, and age, to gain better understanding of the balance of benefit and harms on which to base recommendations for practice.

scholarly journals Conservative vs liberal fluid therapy in septic shock (CLASSIC) trial—Protocol and statistical analysis plan

2019 ◽  
Vol 63 (9) ◽  
pp. 1262-1271 ◽  
Author(s):  
Tine Sylvest Meyhoff ◽  
Peter Buhl Hjortrup ◽  
Morten Hylander Møller ◽  
Jørn Wetterslev ◽  
Theis Lange ◽  
...  
Keyword(s):  
Septic Shock ◽  
Statistical Analysis ◽  
Fluid Therapy ◽  
Statistical Analysis Plan ◽  
Trial Protocol

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 the WOMAN-ETAPlaT study: Effect of tranexamic acid on platelet function and thrombin generation

2016 ◽  
Vol 1 ◽  
pp. 30 ◽  
Author(s):  
Kastriot Dallaku ◽  
Haleema Shakur ◽  
Phil Edwards ◽  
Danielle Beaumont ◽  
Ian Roberts ◽  
...  
Keyword(s):  
Statistical Analysis ◽  
Tranexamic Acid ◽  
Platelet Function ◽  
Thrombin Generation ◽  
Postpartum Haemorrhage ◽  
Coagulation Factors ◽  
Statistical Analysis Plan ◽  
Adult Women ◽  
Life Threatening

Background. Postpartum haemorrhage (PPH) is a potentially life-threatening complication for women, and the leading cause of maternal mortality. Tranexamic acid (TXA) is an antifibrinolytic used worldwide to treat uterine haemorrhage and to reduce blood loss in general surgery. TXA may have effects on thrombin generation, platelet function and coagulation factors as a result of its inhibition on the plasmin. Methods. WOMAN ETAPlaT is a sub-study of the World Maternal Antifibrinolitic trial (WOMAN trial). All adult women clinically diagnosed with PPH after a vaginal delivery or caesarean section, are eligible for inclusion in the study. Blood samples will be collected at the baseline and 30 minutes after the first dose of study treatment is given. Platelet function will be evaluated in whole blood immediately after sampling with Multiplate® tests (ADPtest and TRAPtest). Thrombin generation, fibrinogen, D-dimer, and coagulation factors vW, V and VIII will be analysed using platelet poor plasma. Results. Recruitment to WOMAN ETAPlaT started on 04 November 2013 and closed on 13 January 2015, during this time  188 patients were recruited. The final participant follow-up was completed on 04 March 2015. This article introduces the statistical analysis plan for the study, without reference to unblinded data.   Conclusion. The data from this study will provide evidence for the effect of TXA on thrombin generation, platelet function and coagulation factors in women with PPH. Trial registration: ClinicalTrials.gov Identifier: NCT00872469; ISRCTN76912190

scholarly journals Statistical analysis plan (SAP) for the 5- and 10-year follow-up assessments of the FIDELITY trial

2019 ◽  
Author(s):  
Raine Sihvonen ◽  
Roope Kalske ◽  
Martin Englund ◽  
Aleksandra Turkiewicz ◽  
Pirjo Toivonen ◽  
...  
Keyword(s):  
Statistical Analysis ◽  
Controlled Trial ◽  
Statistical Analysis Plan ◽  
Meniscus Tear ◽  
Meniscal Lesion ◽  
Long Term Outcomes ◽  
Arthroscopic Partial Meniscectomy ◽  
Adult Age

Abstract Background The research objectives of the 5- and 10-year assessments of the Finnish Degenerative Meniscal Lesion Study (FIDELITY) are two-fold: 1) to assess the long-term efficacy of arthroscopic partial meniscectomy (APM) in adult (age 35 to 65 years) patients with a degenerative meniscus tear, and 2) to determine the respective effects of APM and degenerative meniscus tear on the development of radiographic and clinical knee osteoarthritis (OA). Methods and Design FDELITY is an ongoing multi-centre, randomized, participant and outcome assessor blinded, placebo-surgery controlled trial of 146 patients. This statistical analysis plan (SAP) article describes the overall principles for analysis of long-term outcomes (5- and 10-year follow-ups), including how participants will be included in each analysis, the primary and secondary outcomes and their respective analyses, adjustments for covariates, and the presentation of the results. In addition, we will present the planned sensitivity and subgroup analyses.

scholarly journals Effect of tranexamic acid on coagulation and fibrinolysis in women with postpartum haemorrhage (WOMAN-ETAC): protocol and statistical analysis plan for a randomized controlled trial

2016 ◽  
Vol 1 ◽  
pp. 31 ◽  
Author(s):  
Haleema Shakur ◽  
Bukola Fawole ◽  
Modupe Kuti ◽  
Oladapo O. Olayemi ◽  
Adenike Bello ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Statistical Analysis ◽  
Tranexamic Acid ◽  
Postpartum Haemorrhage ◽  
Controlled Trial ◽  
Statistical Analysis Plan ◽  
Trial Protocol ◽  
Randomized Controlled ◽  
Link Type ◽  
Trial Participants

Background: Postpartum haemorrhage (PPH) is a leading cause of maternal death. Tranexamic acid has the potential to reduce bleeding and a large randomized controlled trial of its effect on maternal health outcomes in women with PPH (The WOMAN trial) is ongoing. We will examine the effect of tranexamic acid on fibrinolysis and coagulation in a subset of WOMAN trial participants. Methods: Adult women with clinically diagnosed primary PPH after vaginal or caesarean delivery are eligible for inclusion in the WOMAN trial. In a sub-group of trial participants, blood samples will be collected at baseline and 30 minutes after the first dose of tranexamic acid or matching placebo.  Our primary objective is to evaluate the effect of tranexamic acid on fibrinolysis. Fibrinolysis will be assessed by measuring D-dimers and by rotational thromboelastometry (ROTEM). Secondary outcomes are international normalized ratio (INR), prothrombin time (PT), activated partial thromboplastin time (APTT), fibrinogen, haemoglobin and platelets. We aim to include about 180 women from the University College Hospital, Ibadan in Nigeria. Discussion: This sub-study of WOMAN trial participants should provide information on the mechanism of action of tranexamic acid in women with postpartum haemorrhage. We present the trial protocol and statistical analysis plan. The trial protocol was registered prior to the start of patient recruitment. The statistical analysis plan was completed before un-blinding. Trial registration:The trial was registered:ClinicalTrials.gov, Identifier NCT00872469https://clinicaltrials.gov/ct2/show/NCT00872469; ISRCTN registry, Identifier ISRCTN76912190http://www.isrctn.com/ISRCTN76912190(Registration date: 22/03/2012).

scholarly journals Statistical analysis plan for the 5- and 10-year follow-up assessments of the FIDELITY trial

2019 ◽  
Author(s):  
Raine Sihvonen ◽  
Roope Kalske ◽  
Martin Englund ◽  
Aleksandra Turkiewicz ◽  
Pirjo Toivonen ◽  
...  
Keyword(s):  
Statistical Analysis ◽  
Knee Osteoarthritis ◽  
Controlled Trial ◽  
Statistical Analysis Plan ◽  
Primary Objective ◽  
Meniscus Tear ◽  
Second Primary ◽  
Term Efficacy

Abstract Background: The research objectives of the 5- and 10-year assessments of the Finnish Degenerative Meniscal Lesion Study (FIDELITY) are two-fold: 1) to assess the long-term efficacy of arthroscopic partial meniscectomy (APM) in adult (age 35 to 65 years) patients with a degenerative meniscus tear, and 2) to determine the respective effects of APM and degenerative meniscus tear on the development of radiographic and clinical knee osteoarthritis (OA). Methods and Design: FDELITY is an ongoing multi-centre, randomized, participant and outcome assessor blinded, placebo-surgery controlled trial of 146 patients. This statistical analysis plan (SAP) article describes the overall principles for analysis of long-term outcomes (5- and 10-year follow-ups), including how participants will be included in each analysis, the primary and secondary outcomes and their respective analyses, adjustments for covariates, and the presentation of the results. In addition, we will present the planned sensitivity and subgroup analyses. Discussion: To study whether APM (resection of torn meniscus tear) per se accelerates or delays the development of knee osteoarthritis in patients with an arthroscopically-verified degenerative tear of the medial meniscus, we are carrying out pre-registered long-term (5- and 10-year) follow-up of our placebo-surgery controlled FIDELITY trial according to statistical principles outlined in detail in this document. We have also outlined the analyses intended to assess our second primary objective, the long-term efficacy of APM on knee symptoms and function.

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