The standard approach for analysing a randomized clinical trial is based on intent-to-treat (ITT) where subjects are analysed according to their assigned treatment group regardless of actual adherence to the treatment protocol. For therapeutic equivalence trials, it is a common concern that an ITT analysis increases the chance of erroneously concluding equivalence. In this paper, we formally investigate the impact of non-compliance on an ITT analysis of equivalence trials with a binary outcome. We assume 'all-or-none' compliance and independence between compliance and the outcome. Our results indicate that non-compliance does not always make it easier to demonstrate equivalence. The direction and magnitude of changes in the type I error rate and power of the study depend on the patterns of non-compliance, event probabilities, the margin of equivalence and other factors.
Download full-text PDF |
Source |
|---|---|
| http://dx.doi.org/10.1002/sim.2230 | DOI Listing |
Publication Analysis
Top Keywords
Similar Publications
Effect of group-based nutritional education combined with individual standard care for outpatients with type 2 diabetes: study protocol for a randomized clinical trial {1}.
Trials
March 2025
Post-Graduate Program in Nutrition, Food and Health, Universidade Federal Do Rio Grande Do Sul, Porto Alegre, Brazil.
Background: Diabetes remains a significant contributor to global morbidity and mortality in the twenty-first century. Lifestyle modification strategies are widely recommended for effective diabetes management. Research suggests that a person-centered approach, implemented in either group or individual settings, offers considerable potential for improving long-term disease outcomes.
View Article and Find Full Text PDFNon-inferiority of sodium zirconium cyclosilicate versus potassium-restricted diet in achieving normokalaemia in patients with type 2 diabetes mellitus: protocol for a multicentre, open-label, randomised controlled, two-arm clinical trial (SILVERSTAR study).
BMJ Open
March 2025
Department of Endocrinology and Metabolism, Kyoto Prefectural University of Medicine School of Medicine Graduate School of Medical Science, Kyoto, Japan.
Background: To effectively manage the progression of diabetic kidney disease, it is essential to address the associated hyperkalaemia while concurrently using renin-angiotensin-aldosterone system inhibitors and mineralocorticoid receptor antagonists. In this study, we aim to evaluate the effects of administering sodium zirconium cyclosilicate (SZC) to patients with type 2 diabetes mellitus (T2DM) complicated by hyperkalaemia.
Methods And Analysis: A total of 80 patients with type 2 diabetes and hyperkalaemia will be included in the study and randomly stratified into two groups.
Assessing non-inferiority for binary matched-pairs data with missing values: a powerful and flexible GEE approach based on the risk difference.
BMC Med Res Methodol
February 2025
Institute of Biometry and Clinical Epidemiology, Charité - Universitätsmedizin, Freie Universität Berlin and Humboldt-Universität Zu Berlin, Charitéplatz 1, 10117, Berlin, Germany.
Background: Clinical studies often aim to test the non-inferiority of a treatment compared to an alternative intervention with binary matched-pairs data. These studies are often planned with methods for completely observed pairs only. However, if missingness is more frequent than expected or is anticipated in the planning phase, methods are needed that allow the inclusion of partially observed pairs to improve statistical power.
View Article and Find Full Text PDFTebipenem pivoxil as an alternative to ceftriaxone for clinically non-responding children with shigellosis: a randomised non-inferiority trial protocol.
BMJ Open
February 2025
Clinical Sciences Division (CSD); Centre for Nutrition and Food Security (CNFS), International Centre for Diarrhoeal Disease Research Bangladesh, Dhaka, Bangladesh.
Introduction: Shigellosis is the second leading cause of diarrhoeal deaths among children worldwide. Oral azithromycin and intravenous ceftriaxone are the recommended first-line and second-line therapies for shigellosis in Bangladesh, respectively, but growing antibiotic resistance will require new antibiotic options. Tebipenem pivoxil, an orally administered carbapenem antibiotic with activity against many strains of antibiotic-resistant bacteria, may be a viable option.
View Article and Find Full Text PDFSingle-stage surgery with antibiotic-loaded hydrogel-coated implants versus two-stage surgery for chronic periprosthetic hip joint infection in French tertiary referral hospitals: the SINBIOSE-H non-inferiority, randomised, controlled trial study protocol.
BMJ Open
February 2025
Service d'Infectiologie, CIC-1408 INSERM Vaccinologie, CHU St. Etienne, Saint-Etienne, France.
Introduction: Chronic hip prosthetic joint infection (PJI) treatment needs non-conservative surgery. The recommended treatment follows a two-stage protocol. Between the two surgeries, full-weight bearing is prohibited, and joint stiffness and pain are rather usual complications.
View Article and Find Full Text PDFWant AI Summaries of new PubMed Abstracts delivered to your In-box?
Enter search terms and have AI summaries delivered each week - change queries or unsubscribe any time!