Trials - McMaster Experts

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Conditional versus non-conditional incentives to maximise return of participant completed questionnaires in clinical trials: a cluster randomised study within a trial 2023
A new instrument to assess the credibility of effect modification analyses (ICEMAN) in randomized controlled trials and meta-analyses 2019
Assessing differences in start-up between a pilot and main RCT in the ICU: The CYCLE international multicentre rehabilitation study 2019
Introducing the CONsolidated Standards of Reporting Trials (CONSORT) statement for randomised controlled trials (RCTs) using cohorts and routinely collected health data 2019
What proportion of ethically approved randomised clinical trials can be found in a trial registry? 2019
Considerations in designing equity-relevant clinical trials 2017
Mediation analysis to explore causal mechanisms in trials of complex interventions 2017
On synthesis evidence from explanatory and pragmatic trials: a comparison of meta-analytic methods 2017
Pilot and feasibility studies: a systematic review of studies conducted at the population health research institute 2017
Statistical considerations for analyzing multiplex biomarker data from prospective studies 2017
MATERNAL VITAMIN D SUPPLEMENTATION DURING PREGNANCY AND LACTATION TO PROMOTE INFANT GROWTH IN DHAKA, BANGLADESH (MDIG TRIAL): A RANDOMIZED CONTROLLED TRIAL 2017
Defining feasibility and pilot studies in preparation for randomised controlled trials: using consensus methods and validation to develop a conceptual framework 2015
EBRNetwork – a call to action for evidence-based research 2015
Improving the reporting of randomised pilot and feasibility studies: a consort statement extension 2015
Transforming healthcare by prioritizing qualitative and quantitative clinical trial evidence: evaluating the Aging, Community and Health Research Unit's Community Partnership Program for Older Adults (ACHRU-CPP).. 26:154. 2025
Enrolment patterns in a randomized controlled trial of probiotics in critically ill patients: a retrospective analysis of the PROSPECT trial.. 25:851. 2024
A survey to determine the zone of equipoise for the Proximal FEmur Resection or Internal Fixation fOR Metastases (PERFORM) randomized controlled trial.. 25:759. 2024
Improving analysis of cognitive outcomes in cardiovascular trials using different statistical approaches.. 25:644. 2024
Rapid normalization of vitamin D deficiency in PICU (VITdALIZE-KIDS): study protocol for a phase III, multicenter randomized controlled trial.. 25:619. 2024
Reflections on the challenges of conducting an international multicentre randomized controlled trial of balance training in addition to pulmonary rehabilitation and its impact on fall incidence in people with COPD. 25:487. 2024
Accounting for center-level effects in multicenter randomized controlled trials. 25:390. 2024
Prevention of persistent pain with lidocaine infusions in breast cancer surgery (PLAN): study protocol for a multicenter randomized controlled trial. 25:337. 2024
Assessing fragility of statistically significant findings from randomized controlled trials assessing pharmacological therapies for opioid use disorders: a systematic review. 25:286. 2024
Does the use of higher versus lower oxygen concentration improve neurodevelopmental outcomes at 18–24 months in very low birthweight infants?. 25:237. 2024
The Diaphragmatic Initiated Ventilatory Assist (DIVA) trial: study protocol for a randomized controlled trial comparing rates of extubation failure in extremely premature infants undergoing extubation to non-invasive neurally adjusted ventilatory assist versus non-synchronized nasal intermittent positive pressure ventilation. 25:201. 2024
REVISE: re-evaluating the inhibition of stress erosions in the ICU—statistical analysis plan for a randomized trial. 24:796. 2023
Detailed statistical analysis plan for a secondary Bayesian analysis of the SafeBoosC-III trial: a multinational, randomised clinical trial assessing treatment guided by cerebral oximetry monitoring versus usual care in extremely preterm infants. 24:737. 2023
Community-based type 2 diabetes care by lay village health workers in rural Lesotho: protocol for a cluster-randomized trial within the ComBaCaL cohort study (ComBaCaL T2D TwiC). 24:688. 2023
Mobile phone text messaging plus motivational interviewing versus usual care: study protocol for a randomized controlled trial to evaluate effects on breastfeeding, child health, and survival outcomes, among women living with HIV (MTI-MI). 24:639. 2023
Frequency of screening and SBT Technique Trial—North American Weaning Collaboration (FAST-NAWC): an update to the protocol and statistical analysis plan. 24:626. 2023
Proton pump inhibitors in critically ill mechanically ventilated patients with COVID-19: protocol for a substudy of the Re-EValuating the Inhibition of Stress Erosions (REVISE) Trial. 24:561. 2023
Correction: Cognitive Behavioural Therapy to Optimize Post-Operative Fracture Recovery (COPE): protocol for a randomized controlled trial. 24:142. 2023
Knowledge mobilization activities to support decision-making by youth, parents, and adults using a systematic and living map of evidence and recommendations on COVID-19: protocol for three randomized controlled trials and qualitative user-experience studies. 24:27. 2023
Randomized controlled trial of an internet-based self-guided hand exercise program to improve hand function in people with systemic sclerosis: the Scleroderma Patient-centered Intervention Network Hand Exercise Program (SPIN-HAND) trial. 23:994. 2022
A longitudinal assessment of trial protocols approved by research ethics committees: The Adherance to SPIrit REcommendations in the UK (ASPIRE-UK) study. 23:601. 2022
Correction: Lessons learned from Integrated Management Program Advancing Community Treatment of Atrial Fibrillation (IMPACT-AF): a pragmatic clinical trial of computerized decision support in primary care. 23:547. 2022
Effectiveness of the Shenzhuo formula in the treatment of patients with macroalbuminuria secondary to diabetic kidney disease: protocol update and statistical analysis plan. 23:61. 2022
Intensity matters: protocol for a randomized controlled trial exercise intervention for individuals with chronic stroke. 23:442. 2022
Prospective, randomized, controlled, double-blind, multi-center, multinational study on the safety and efficacy of 6% Hydroxyethyl starch (HES) sOlution versus an Electrolyte solutioN In patients undergoing eleCtive abdominal Surgery: study protocol for the PHOENICS study. 23:168. 2022
Rationale and design of the PeriOperative ISchemic Evaluation-3 (POISE-3): a randomized controlled trial evaluating tranexamic acid and a strategy to minimize hypotension in noncardiac surgery. 23:101. 2022
Retention in RCTs of physical rehabilitation for adults with frailty: a systematic review and meta-analysis. 23:235. 2022
The Mirasol Evaluation of Reduction in Infections Trial (MERIT): study protocol for a randomized controlled clinical trial. 23:257. 2022
The Transitions to Long-term In Home Ventilator Engagement Study (Transitions to LIVE): study protocol for a pragmatic randomized controlled trial. 23:125. 2022
Use of the oral beta blocker bisoprolol to reduce the rate of exacerbation in people with chronic obstructive pulmonary disease (COPD): a randomised controlled trial (BICS). 23:307. 2022
Cognitive Behavioural Therapy to Optimize Post-Operative Fracture Recovery (COPE): protocol for a randomized controlled trial. 23:894. 2022
A randomised placebo-controlled trial of the effectiveness of early metformin in addition to usual care in the reduction of gestational diabetes mellitus effects (EMERGE): study protocol. 23:795. 2022
A pragmatic randomized trial evaluating pre-operative aqueous antiseptic skin solutions in open fractures (Aqueous-PREP): statistical analysis plan. 23:772. 2022
Research interrupted: applying the CONSERVE 2021 Statement to a randomized trial of rehabilitation during critical illness affected by the COVID-19 pandemic. 23:735. 2022
Lessons from the COVID-19 pandemic and recent developments on the communication of clinical trials, publishing practices, and research integrity: in conversation with Dr. David Moher. 23:671. 2022
Efficacy of the cognitive functional therapy (CFT) in patients with chronic nonspecific low back pain: a study protocol for a randomized sham-controlled trial.. 23:544. 2022
Development and evaluation of rapid data-enabled access to routine clinical information to enhance early recruitment to the national clinical platform trial of COVID-19 community treatments. 23:62. 2022
A prospective, randomized, single-blinded, crossover trial to investigate the effect of a wearable device in addition to a daily symptom diary for the Remote Early Detection of SARS-CoV-2 infections (COVID-RED): a structured summary of a study protocol for a randomized controlled trial. 22:694. 2021
A prospective, randomized, single-blinded, crossover trial to investigate the effect of a wearable device in addition to a daily symptom diary for the remote early detection of SARS-CoV-2 infections (COVID-RED): a structured summary of a study protocol for a randomized controlled trial. 22:412. 2021
A trial platform to assess approved SARS-CoV-2 vaccines in immunocompromised patients: first sub-protocol for a pilot trial comparing the mRNA vaccines Comirnaty® and COVID-19 mRNA Vaccine Moderna®. 22:724. 2021
Advancing collaborations in health research and clinical trials in Sub-Saharan Africa: development and implementation of a biostatistical collaboration module in the Masters in Biostatistics Program at Stellenbosch University. 22:478. 2021
Combination of first-line chemotherapy with Kanglaite injections versus first-line chemotherapy alone for advanced non-small-cell lung cancer: study protocol for an investigator-initiated, multicenter, open-label, randomized controlled trial. 22:214. 2021
Comparison of efficacy of a 7-day versus a 14-day course of intravenous antibiotics in the treatment of uncomplicated neonatal bacterial sepsis: study protocol of a randomized controlled non-inferiority trial. 22:859. 2021
Confidence interval of risk difference by different statistical methods and its impact on the study conclusion in antibiotic non-inferiority trials. 22:708. 2021
Deprescribing to reduce polypharmacy: study protocol for a randomised controlled trial assessing deprescribing of anticholinergic and sedative drugs in a cohort of frail older people living in the community. 22:766. 2021
Exploring reasons for recruitment failure in clinical trials: a qualitative study with clinical trial stakeholders in Switzerland, Germany, and Canada. 22:844. 2021
Feasibility study protocol of a pragmatic, randomised controlled pilot trial: membrane sweeping to prevent post-term pregnancy—the MILO Study. 22:113. 2021
Lessons learned from Integrated Management Program Advancing Community Treatment of Atrial Fibrillation (IMPACT-AF): a pragmatic clinical trial of computerized decision support in primary care. 22:531. 2021
PRagMatic Pediatric Trial of Balanced vs nOrmaL Saline FlUid in Sepsis: study protocol for the PRoMPT BOLUS randomized interventional trial. 22:776. 2021
Prophylactic Antibiotic Regimens In Tumor Surgery (PARITY): a multi-center randomized controlled study comparing alternative antibiotic regimens in patients undergoing tumor resections with endoprosthetic replacements—a statistical analysis plan. 22:223. 2021
Recruitment patterns in a large international randomized controlled trial of perioperative care in cancer patients. 22:219. 2021
Simple compared to covariate-constrained randomization methods in balancing baseline characteristics: a case study of randomly allocating 72 hemodialysis centers in a cluster trial. 22:626. 2021
Standardised Outcomes in Nephrology – Chronic Kidney Disease (SONG-CKD): a protocol for establishing a core outcome set for adults with chronic kidney disease who do not require kidney replacement therapy. 22:612. 2021
Team approach to polypharmacy evaluation and reduction: study protocol for a randomized controlled trial. 22:746. 2021
The Scleroderma Patient-centered Intervention Network Self-Management (SPIN-SELF) Program: protocol for a two-arm parallel partially nested randomized controlled feasibility trial with progression to full-scale trial. 22:856. 2021
The intranasal dexmedetomidine plus ketamine for procedural sedation in children, adaptive randomized controlled non-inferiority multicenter trial (Ketodex): a statistical analysis plan. 22:15. 2021
Convalescent plasma for adults with acute COVID-19 respiratory illness (CONCOR-1): study protocol for an international, multicentre, randomized, open-label trial. 22:323. 2021
A brief transdiagnostic psychological intervention for Afghan asylum seekers and refugees in Austria: a randomized controlled trial. 21:57. 2020
A call for consensus in defining efficacy in clinical trials for opioid addiction: combined results from a systematic review and qualitative study in patients receiving pharmacological assisted therapy for opioid use disorder. 21:30. 2020
A pilot randomized controlled trial of 7 versus 14 days of antibiotic treatment for bloodstream infection on non-intensive care versus intensive care wards. 21:92. 2020
A three-arm, multicenter, open-label randomized controlled trial of hydroxychloroquine and low-dose prednisone to treat recurrent pregnancy loss in women with undifferentiated connective tissue diseases: protocol for the Immunosuppressant regimens for LIving FEtuses (ILIFE) trial. 21:771. 2020
Aim2Be mHealth intervention for children with overweight and obesity: study protocol for a randomized controlled trial. 21:132. 2020
Analysis and reporting of stratified cluster randomized trials—a systematic survey. 21:930. 2020
COVID-19 randomised trial protocols: rapid publication without barriers. 21:327. 2020
Cluster identification, selection, and description in cluster randomized crossover trials: the PREP-IT trials. 21:712. 2020
Comparison of four COVID-19 screening strategies to facilitate early case identification within the homeless shelter population: A structured summary of a study protocol for a randomised controlled trial. 21:941. 2020
Correction to: Cluster identification, selection, and description in Cluster randomized crossover trials: the PREP-IT trials. 21:821. 2020
Developing and testing the effectiveness of a novel online integrated treatment for problem gambling and tobacco smoking: a protocol for an open-label randomized controlled trial. 21:937. 2020
Development of a Core Outcome Set for Studies on Cardiac Disease in Pregnancy (COSCarP): a study protocol. 21:300. 2020
Digital tools for trial recruitment and retention—plenty of tools but rigorous evaluation is in short supply. 21:476. 2020
Health TAPESTRY Ontario: protocol for a randomized controlled trial to test reproducibility and implementation. 21:714. 2020
Lessening Organ dysfunction with VITamin C (LOVIT): protocol for a randomized controlled trial. 21:42. 2020
Non-steroidal or opioid analgesia use for children with musculoskeletal injuries (the No OUCH study): statistical analysis plan. 21:759. 2020
Normalization of a conversation tool to promote shared decision making about anticoagulation in patients with atrial fibrillation within a practical randomized trial of its effectiveness: a cross-sectional study. 21:395. 2020
Our Choice: study protocol for a randomized controlled trial for optimal implementation of psoriasis treatment by the integration of Chinese and western medicine. 21:299. 2020
Personalized dosing of nicotine replacement therapy versus standard dosing for the treatment of individuals with tobacco dependence: study protocol for a randomized placebo-controlled trial. 21:592. 2020
Prediction of RECRUITment In randomized clinical Trials (RECRUIT-IT)—rationale and design for an international collaborative study. 21:731. 2020
Quantitative response of healthy muscle following the induction of capsaicin: an exploratory randomized controlled trial. 21:1020. 2020
Rationale and design of repeated cross-sectional studies to evaluate the reporting quality of trial protocols: the Adherence to SPIrit REcommendations (ASPIRE) study and associated projects. 21:896. 2020
Reporting of key methodological and ethical aspects of cluster trials in hemodialysis require improvement: a systematic review. 21:752. 2020
Retaining participants in community-based health research: a case example on standardized planning and reporting. 21:393. 2020
Sahaj Samadhi Meditation versus a Health Enhancement Program for depression in chronic pain: protocol for a randomized controlled trial and implementation evaluation. 21:319. 2020
Statistical analysis plan for a cluster-randomised trial assessing the effectiveness of implementation of a bedside evidence-based checklist for clinical management of brain-dead potential organ donors in intensive care units: DONORS (Donation Network to Optimise Organ Recovery Study). 21:540. 2020
Trial Forge Guidance 2: how to decide if a further Study Within A Trial (SWAT) is needed. 21:33. 2020
The BEACON study: protocol for a cohort study as part of an evaluation of the effectiveness of smartphone-assisted problem-solving therapy in men who present with intentional self-harm to emergency departments in Ontario. 21:925. 2020
A randomised controlled trial assessing the use of citalopram, sertraline, fluoxetine and mirtazapine in preventing relapse in primary care patients who are taking long-term maintenance antidepressants (ANTLER: ANTidepressants to prevent reLapse in dEpRession): study protocol for a randomised controlled trial. 20:319. 2019
Comparison of randomized controlled trials discontinued or revised for poor recruitment and completed trials with the same research question: a matched qualitative study. 20:800. 2019
Correction to: Prevention of Infections in Cardiac Surgery study (PICS): study protocol for a pragmatic cluster-randomized factorial crossover pilot trial. 20:595. 2019
Correction to: Project management lessons learned from the multicentre CYCLE pilot randomized controlled trial. 20:606. 2019
Design and rationale for a pragmatic cluster randomized trial of the Cardiovascular Health Awareness Program (CHAP) for social housing residents in Ontario and Quebec, Canada. 20:760. 2019
Development of the IRIS-AR strategy: an intervention to improve rates of accrual and retention for the VTE-PRO randomized controlled trial. 20:447. 2019
Improving outcome reporting in clinical trial reports and protocols: study protocol for the Instrument for reporting Planned Endpoints in Clinical Trials (InsPECT). 20:161. 2019
Multimorbidity risk assessment in adolescents and adults with cerebral palsy: a protocol for establishing a core outcome set for clinical research and practice. 20:176. 2019
Population health intervention research: the place of theories. 20:285. 2019
Population health intervention research: what is the place for pilot studies?. 20:309. 2019
Project management lessons learned from the multicentre CYCLE pilot randomized controlled trial. 20:532. 2019
Protocol for a randomised controlled trial to evaluate the effectiveness of improving tuberculosis patients’ treatment adherence via electronic monitors and an app versus usual care in Tibet. 20:273. 2019
Rationale and methods of an Evaluation of the Effectiveness of the Community Paramedicine at Home (CP@home) program for frequent users of emergency medical services in multiple Ontario regions: a study protocol for a randomized controlled trial. 20:75. 2019
Systematic review of basket trials, umbrella trials, and platform trials: a landscape analysis of master protocols. 20:572. 2019
The effects of two early parenting interventions on child aggression and risk for violence in Brazil (The PIÁ Trial): protocol for a randomised controlled trial. 20:253. 2019
What happens to intimate partner violence studies registered on clinicaltrials.gov? A systematic review of a clinical trials registry. 20:288. 2019
Who says “no” to participating in stroke clinical trials and why: an observational study from the Vancouver Stroke Program. 20:313. 2019
Zwakala Ndoda: a cluster and individually randomized trial aimed at improving testing, linkage, and adherence to treatment for hard-to reach men in KwaZulu-Natal, South Africa. 20:798. 2019
Frequency of Screening and SBT Technique Trial - North American Weaning Collaboration (FAST-NAWC): a protocol for a multicenter, factorial randomized trial. 20:587. 2019
7 versus 14 days of antibiotic treatment for critically ill patients with bloodstream infection: a pilot randomized clinical trial. 19:111. 2018
A cluster randomised trial of a classroom communication resource program to change peer attitudes towards children who stutter among grade 7 students. 19:664. 2018
Chinese herbal medicine Shenzhuo Formula treatment in patients with macroalbuminuria secondary to diabetic kidney disease: study protocol for a randomized controlled trial. 19:200. 2018
DELTA2 guidance on choosing the target difference and undertaking and reporting the sample size calculation for a randomised controlled trial. 19:606. 2018
Development of a Core Outcome Set for Studies on Obesity in Pregnant Patients (COSSOPP): a study protocol. 19:655. 2018
Exploring factors associated with views on sharing of certain interim trial result measures by the data safety monitoring board (DSMB) with non-DSMB members. 19:621. 2018
FIT for FUNCTION: study protocol for a randomized controlled trial. 19:39. 2018
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. 19:588. 2018
Identifying trial recruitment uncertainties using a James Lind Alliance Priority Setting Partnership – the PRioRiTy (Prioritising Recruitment in Randomised Trials) study. 19:147. 2018
Outcome Measures in Rheumatology - Interventions for medication Adherence (OMERACT-Adherence) Core Domain Set for Trials of Interventions for Medication Adherence in Rheumatology: 5 Phase Study Protocol. 19:204. 2018
Prevention of Infections in Cardiac Surgery study (PICS): study protocol for a pragmatic cluster-randomized factorial crossover pilot trial. 19:688. 2018
Short-course antimicrobial therapy for paediatric respiratory infections (SAFER): study protocol for a randomized controlled trial. 19:83. 2018
Statistical analysis plan for a cluster-randomized crossover trial comparing the effectiveness and safety of a flexible family visitation model for delirium prevention in adult intensive care units (the ICU Visits Study). 19:636. 2018
Statistical analysis plan for the Pneumatic CompREssion for PreVENting Venous Thromboembolism (PREVENT) trial: a study protocol for a randomized controlled trial. 19:182. 2018
Structured diet and exercise guidance in pregnancy to improve health in women and their offspring: study protocol for the Be Healthy in Pregnancy (BHIP) randomized controlled trial. 19:691. 2018
Survey of professional views on sharing interim results by the Data Safety Monitoring Board (DSMB): what to share, with whom and why. 19:281. 2018
The Classroom Communication Resource (CCR) intervention to change peer’s attitudes towards children who stutter (CWS): study protocol for a randomised controlled trial. 19:43. 2018
The Comparative Effectiveness of Innovative Treatments for Cancer (CEIT-Cancer) project: Rationale and design of the database and the collection of evidence available at approval of novel drugs. 19:505. 2018
Using acute tryptophan depletion to investigate predictors of treatment response in adolescents with major depressive disorder: study protocol for a randomised controlled trial. 19:434. 2018
Internet-based cognitive behavioural therapy (iCBT) for perinatal anxiety and depression versus treatment as usual: study protocol for two randomised controlled trials.. 19:56. 2018
Barriers and facilitators to healthcare professional behaviour change in clinical trials using the Theoretical Domains Framework: a case study of a trial of individualized temperature-reduced haemodialysis. 18:227. 2017
Challenges to complete and useful data sharing. 18:71. 2017
Determining the impact of a new physiotherapist-led primary care model for back pain: protocol for a pilot cluster randomized controlled trial. 18:526. 2017
Feasibility of a Systematic, Comprehensive, One-to-One Training (SCOOT) program for new scooter users: study protocol for a randomized control trial. 18:235. 2017
Interactive weekly mobile phone text messaging plus motivational interviewing in promotion of breastfeeding among women living with HIV in South Africa: study protocol for a randomized controlled trial. 18:331. 2017
Intrapleural Dornase and Tissue Plasminogen Activator in pediatric empyema (DTPA): a study protocol for a randomized controlled trial. 18:293. 2017
Nitrous oxide (N2O) and subsequent open-label SSRI treatment of adolescents with depression (NOTAD): study protocol for a randomised controlled trial. 18:617. 2017
Promoting deceased organ and tissue donation registration in family physician waiting rooms (RegisterNow-1 trial): study protocol for a pragmatic, stepped-wedge, cluster randomized controlled registry. 18:610. 2017
Sharing interim trial results by the Data Safety Monitoring Board with those responsible for the trial’s conduct and progress: a narrative review. 18:120. 2017
The ACHRU-CPP versus usual care for older adults with type-2 diabetes and multiple chronic conditions and their family caregivers: study protocol for a randomized controlled trial. 18:55. 2017
The SYGMA programme of phase 3 trials to evaluate the efficacy and safety of budesonide/formoterol given ‘as needed’ in mild asthma: study protocols for two randomised controlled trials. 18:12. 2017
The effectiveness of a Supported Self-management task-shifting intervention for adult depression in Vietnam communities: study protocol for a randomized controlled trial. 18:209. 2017
A patient decision aid for antidepressant use in pregnancy: study protocol for a randomized controlled trial. 17:110. 2016
A trial to determine whether septic shock-reversal is quicker in pediatric patients randomized to an early goal-directed fluid-sparing strategy versus usual care (SQUEEZE): study protocol for a pilot randomized controlled trial. 17:556. 2016
Accounting for treatment by center interaction in sample size determinations and the use of surrogate outcomes in the pessary for the prevention of preterm birth trial: a simulation study. 17:310. 2016
Cost-effective recruitment methods for a large randomised trial in people with diabetes: A Study of Cardiovascular Events iN Diabetes (ASCEND). 17:286. 2016
Efficacy of ultra-micronized palmitoylethanolamide (um-PEA) in geriatric patients with chronic pain: study protocol for a series of N-of-1 randomized trials. 17:369. 2016
Magnesium nebulization utilization in management of pediatric asthma (MagNUM PA) trial: study protocol for a randomized controlled trial. 17:261. 2016
Probiotics: Prevention of Severe Pneumonia and Endotracheal Colonization Trial—PROSPECT: a pilot trial. 17:377. 2016
Steroids in fluid and/or vasoactive infusion dependent pediatric shock: study protocol for a randomized controlled trial. 17:238. 2016
The effect of berberine on insulin resistance in women with polycystic ovary syndrome: detailed statistical analysis plan (SAP) for a multicenter randomized controlled trial. 17:512. 2016
The ethics of future trials: qualitative analysis of physicians’ decision making. 17:12. 2016
Bacteremia Antibiotic Length Actually Needed for Clinical Effectiveness (BALANCE): study protocol for a pilot randomized controlled trial. 16:173. 2015
Can an antimicrobial stewardship program reduce length of stay of immune-competent adult patients admitted to hospital with diagnosis of community-acquired pneumonia? Study protocol for pragmatic controlled non-randomized clinical study. 16:355. 2015
Chronic pain self-management support with pain science education and exercise (COMMENCE): study protocol for a randomized controlled trial. 16:462. 2015
Decision aid on radioactive iodine treatment for early stage papillary thyroid cancer: update to study protocol with follow-up extension. 16:302. 2015
Effectiveness of pharmaceutical care at discharge in the emergency department: study protocol of a randomized controlled trial. 16:60. 2015
Evaluating processes of care and outcomes of children in hospital (EPOCH): study protocol for a randomized controlled trial. 16:245. 2015
Logistic, ethical, and political dimensions of stepped wedge trials: critical review and case studies. 16:351. 2015
Maternal vitamin D supplementation during pregnancy and lactation to promote infant growth in Dhaka, Bangladesh (MDIG trial): study protocol for a randomized controlled trial. 16:300. 2015
Nortriptyline in knee osteoarthritis (NortIKA Study): study protocol for a randomised controlled trial. 16:448. 2015
Opioid substitution and antagonist therapy trials exclude the common addiction patient: a systematic review and analysis of eligibility criteria. 16:475. 2015
Preconditioning Shields Against Vascular Events in Surgery (SAVES), a multicentre feasibility trial of preconditioning against adverse events in major vascular surgery: study protocol for a randomised control trial. 16:185. 2015
Reducing the confusion and controversies around pragmatic trials: using the Cardiovascular Health Awareness Program (CHAP) trial as an illustrative example. 16:387. 2015
Strategic use of new generation antidepressants for depression: SUN(^_^) D protocol update and statistical analysis plan. 16:459. 2015
Successful knowledge translation intervention in long-term care: final results from the vitamin D and osteoporosis study (ViDOS) pilot cluster randomized controlled trial. 16:214. 2015
Sustained Aeration of Infant Lungs (SAIL) trial: study protocol for a randomized controlled trial. 16:95. 2015
Virtual colonoscopy, optical colonoscopy, or fecal occult blood testing for colorectal cancer screening: results of a pilot randomized controlled trial. 16:296. 2015
Comparison between the standard and a new alternative format of the Summary-of-Findings tables in Cochrane review users: study protocol for a randomized controlled trial. 16:164-164. 2015
A double-blind, randomized controlled trial to compare the effect of biannual peripheral magnetic resonance imaging, radiography and standard of care disease progression monitoring on pharmacotherapeutic escalation in rheumatoid and undifferentiated inflammatory arthritis: study protocol for a randomized controlled trial. 15:268. 2014
Accounting for center in the Early External Cephalic Version trials: an empirical comparison of statistical methods to adjust for center in a multicenter trial with binary outcomes. 15:377. 2014
Building clinical trial priorities at the University of Rwanda. 15:467. 2014
Comparing the feasibility, acceptability, clinical-, and cost-effectiveness of mental health e-screening to paper-based screening on the detection of depression, anxiety, and psychosocial risk in pregnant women: a study protocol of a randomized, parallel-group, superiority trial. 15:3. 2014
Cord pilot trial - immediate versus deferred cord clamping for very preterm birth (before 32 weeks gestation): study protocol for a randomized controlled trial. 15:258. 2014
Corticosteroid treatment for community-acquired pneumonia - the STEP trial: study protocol for a randomized controlled trial. 15:257. 2014
Economic evaluation of the prophylaxis for thromboembolism in critical care trial (E-PROTECT): study protocol for a randomized controlled trial. 15:502. 2014
Furosemide and albumin for diuresis of edema (FADE): a study protocol for a randomized controlled trial. 15:222. 2014
Impact of emergency department probiotic treatment of pediatric gastroenteritis: study protocol for the PROGUT (Probiotic Regimen for Outpatient Gastroenteritis Utility of Treatment) randomized controlled trial. 15:170. 2014
Implementing evidence-based recommended practices for the management of patients with mild traumatic brain injuries in Australian emergency care departments: study protocol for a cluster randomised controlled trial. 15:281. 2014
Sleep to lower elevated blood pressure: study protocol for a randomized controlled trial. 15:393. 2014
SodiUm SeleniTe Adminstration IN Cardiac Surgery (SUSTAIN CSX-trial): study design of an international multicenter randomized double-blinded controlled trial of high dose sodium-selenite administration in high-risk cardiac surgical patients. 15:339. 2014
Study protocol for a randomized, controlled, superiority trial comparing the clinical and cost- effectiveness of integrated online mental health assessment-referral-care in pregnancy to usual prenatal care on prenatal and postnatal mental health and infant health and development: the Integrated Maternal Psychosocial Assessment to Care Trial (IMPACT). 15:72. 2014
Trial to re-evaluate ultrasound in the treatment of tibial fractures (TRUST): a multicenter randomized pilot study. 15:206. 2014
Sepsis survivors monitoring and coordination in outpatient health care (SMOOTH): study protocol for a randomized controlled trial.. 15:283. 2014
Methodological survey of designed uneven randomization trials (DU-RANDOM): a protocol. 15:33-33. 2014
Randomized controlled trial comparing telephone and mail follow-up for recruitment of participants into a clinical trial of colorectal cancer screening. 14:40. 2013
Definition and reporting of pilot and feasibility studies. 14:o18. 2013
Development and feasibility testing of decision support for patients who are candidates for a prophylactic implantable defibrillator: a study protocol for a pilot randomized controlled trial. 14:346-346. 2013
Feasibility of the Enhancing Participation In the Community by improving Wheelchair Skills (EPIC Wheels) program: study protocol for a randomized controlled trial. 14:350-350. 2013
HIV prevention in favour of the choice-disabled in southern Africa: study protocol for a randomised controlled trial. 14:274-274. 2013
Initiation and continuation of randomized trials after the publication of a trial stopped early for benefit asking the same study question: STOPIT-3 study design. 14:335-335. 2013
Supporting the improvement and management of prescribing for urinary tract infections (SIMPle): protocol for a cluster randomized trial. 14:441-441. 2013
Allocation techniques for balance at baseline in cluster randomized trials: a methodological review. 13:120. 2012
Assessing the effectiveness of ‘pulse radiofrequency treatment of dorsal root ganglion’ in patients with chronic lumbar radicular pain: study protocol for a randomized control trial. 13:52. 2012
Central coordination as an alternative for local coordination in a multicenter randomized controlled trial: the FAITH trial experience. 13:5. 2012
Rapid, easy, and cheap randomization: prospective evaluation in a study cohort. 13:90. 2012
Rationale, study design, and analysis plan of the Alveolar Recruitment for ARDS Trial (ART): Study protocol for a randomized controlled trial. 13:153. 2012
A Canadian Critical Care Trials Group project in collaboration with the international forum for acute care trialists - Collaborative H1N1 Adjuvant Treatment pilot trial (CHAT): study protocol and design of a randomized controlled trial. 12:70. 2011
A prospective, double-blind, randomized, controlled clinical trial comparing standard wound care with adjunctive hyperbaric oxygen therapy (HBOT) to standard wound care only for the treatment of chronic, non-healing ulcers of the lower limb in patients with diabetes mellitus: a study protocol. 12:69. 2011
Canadian-led capacity-building in biostatistics and methodology in cardiovascular and diabetes trials: the CANNeCTIN Biostatistics and Methodological Innovation Working Group. 12:48. 2011
Does clinical equipoise apply to cluster randomized trials in health research?. 12:118. 2011
Effect of selenium supplementation on CD4 T-cell recovery, viral suppression, morbidity and quality of life of HIV-infected patients in Rwanda: study protocol for a randomized controlled trial. 12:192. 2011
Ethical issues posed by cluster randomized trials in health research. 12:100. 2011
Individual participant data meta-analyses compared with meta-analyses based on aggregate data. 12:a57. 2011
Investigator experiences with financial conflicts of interest in clinical trials. 12:9. 2011
The cameroon mobile phone sms (CAMPS) trial: a protocol for a randomized controlled trial of mobile phone text messaging versus usual care for improving adherence to highly active anti-retroviral therapy. 12:5. 2011
The challenges and opportunities of conducting a clinical trial in a low resource setting: The case of the Cameroon mobile phone SMS (CAMPS) trial, an investigator initiated trial. 12:145. 2011
The impact of clinical data on the evaluation of tibial fracture healing. 12:237. 2011
When is informed consent required in cluster randomized trials in health research?. 12:202. 2011
Who is the research subject in cluster randomized trials in health research?. 12:183. 2011
Decision aid on radioactive iodine treatment for early stage papillary thyroid cancer - a randomized controlled trial. 11:81. 2010
Design, analysis, and presentation of crossover trials. 10:27. 2009
Ethical and policy issues in cluster randomized trials: rationale and design of a mixed methods research study. 10:61. 2009
Incorporating multiple interventions in meta-analysis: an evaluation of the mixed treatment comparison with the adjusted indirect comparison. 10:86. 2009
The HAART cell phone adherence trial (WelTel Kenya1): a randomized controlled trial protocol. 10:87. 2009
Wean Earlier and Automatically with New technology (the WEAN study): a protocol of a multicentre, pilot randomized controlled trial. 10:81. 2009
LOST to follow-up Information in Trials (LOST-IT): a protocol on the potential impact. 10:40-40. 2009
Stopping randomized trials early for benefit: a protocol of the Study Of Trial Policy Of Interim Truncation-2 (STOPIT-2). 10:49-49. 2009
Subgroup Analysis of Trials Is Rarely Easy (SATIRE): a study protocol for a systematic review to characterize the analysis, reporting, and claim of subgroup effects in randomized trials. 10:101-101. 2009
Community-based randomised controlled trial evaluating falls and osteoporosis risk management strategies. 9:62. 2008
Reporting of noninferiority and equivalence randomized trials for major prostaglandins: A systematic survey of the ophthalmology literature. 9:69. 2008
What constitutes a "clinical trial"?: A survey of oncology professionals. 9:12. 2008
Dose response of ACE inhibitors: implications of the SECURE trial. 2:155-159. 2001

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