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The influence of bias in randomized controlled trials on rehabilitation intervention effect estimates: what we have learned from meta-epidemiological studies Hasselt University

Chiara Arienti, Susan Armijo-Olivo, Giorgio Ferriero, Peter FEYS, Thomas Hoogeboom, Carlotte Kiekens, Stefano G. Lazzarini, Silvia Minozzi, Stefano Negrini, Aydan Oral, et al.
This study aimed to synthesize evidence from studies that addressed the influence of bias domains in randomized controlled trials on rehabilitation intervention effect estimates and discuss how these findings can maximize the trustworthiness of an RCT in rehabilitation. We screened studies about the influence of bias on rehabilitation intervention effect estimates published until June 2023. The characteristics and results of the included studies ...

Human computation as a new method for evidence-based knowledge transfer in web-based guideline development groups: A proof of concept randomized controlled trial KU Leuven

Annemie Heselmans, Bert Aertgeerts, Peter Donceel, Stijn Van de Velde, Dirk Ramaekers
BACKGROUND: Guideline developers use different consensus methods to develop evidence-based clinical practice guidelines. Previous research suggests that existing guideline development techniques are subject to methodological problems and are logistically demanding. Guideline developers welcome new methods that facilitate a methodologically sound decision-making process. Systems that aggregate knowledge while participants play a game are one ...

Minimization in randomized clinical trials Hasselt University

Elisabeth Coart, Perrine Bamps, Emmanuel Quinaux, Geneviève Sturbois, Everardo D Saad, Tomasz BURZYKOWSKI, Marc BUYSE
In randomized trials, comparability of the treatment groups is ensured through allocation of treatments using a mechanism that involves some random element, thus controlling for confounding of the treatment effect. Completely random allocation ensures comparability between the treatment groups for all known and unknown prognostic factors. For a specific trial, however, imbalances in prognostic factors among the treatment groups may occur. ...

Evaluating newly approved drugs in combination regimens for multidrug-resistant tuberculosis with fluoroquinolone resistance (endTB-Q): study protocol for a multi-country randomized controlled trial Institute of Tropical Medicine

Praharshinie Rupasinghe, S. B. Patil, M. Tamirat, K Khazhidinov, Elisa Ardizzoni, M. Atger, A Austin, E. Baudin, M Bekhit, S Bektasov, et al.

BACKGROUND: Treatment for fluoroquinolone-resistant multidrug-resistant/rifampicin-resistant tuberculosis (pre-XDR TB) often lasts longer than treatment for less resistant strains, yields worse efficacy results, and causes substantial toxicity. The newer anti-tuberculosis drugs, bedaquiline and delamanid, and repurposed drugs clofazimine and linezolid, show great promise for combination in shorter, less-toxic, and effective regimens. To date, ...

Role of cerebral hypoperfusion in multiple sclerosis (ROCHIMS): study protocol for a proof-of-concept randomized controlled trial with bosentan Vrije Universiteit Brussel KU Leuven

Stéphanie Hostenbach, Ayla Pauwels, Veronique Michiels, Hubert Raeymaekers, Anne-Marie Van Binst, Chris Baeken, Annick Van Merhaegen-Wieleman, Peter Van Schuerbeek, Jacques De Keyser, Miguel D'Haeseleer, et al.

Background: Axonal degeneration is related to long-term disability in patients with multiple sclerosis (MS). The underlying mechanism remains ill understood but appears to involve axonal energetic dysfunction. A globally impaired cerebral blood flow (CBF) has been observed in the normal-appearing white matter (NAWM) of patients with MS, which is probably related to astrocytic overexpression of endothelin-1 (ET-1). Cerebral hypoperfusion has ...

Evaluating newly approved drugs for multidrug-resistant tuberculosis (endTB): study protocol for an adaptive, multi-country randomized controlled trial Institute of Tropical Medicine

L. Guglielmetti, Elisa Ardizzoni, M. Atger, E. Baudin, E. Berikova, M. Bonnet, E. Chang, Sandrine Cloez, J. M. Coit, J Cox, et al.

BACKGROUND: Treatment of multidrug- and rifampin-resistant tuberculosis (MDR/RR-TB) is expensive, labour-intensive, and associated with substantial adverse events and poor outcomes. While most MDR/RR-TB patients do not receive treatment, many who do are treated for 18 months or more. A shorter all-oral regimen is currently recommended for only a sub-set of MDR/RR-TB. Its use is only conditionally recommended because of very low-quality ...

Randomised controlled trials (RCTs) in sports injury research Vrije Universiteit Brussel

Daniel Ramskov, Evert Verhagen

BACKGROUND: In randomised controlled trials (RCTs) of interventions that aim to prevent sports injuries, the intention-to-treat principle is a recommended analysis method and one emphasised in the Consolidated Standards of Reporting Trials (CONSORT) statement that guides quality reporting of such trials. However, an important element of injury prevention trials-compliance with the intervention-is not always well-reported. The purpose of the ...

Protocol, rationale and design of BE-PEOPLE (Bedaquiline enhanced exposure prophylaxis for LEprosy in the Comoros): a cluster randomized trial on effectiveness of rifampicin and bedaquiline as post-exposure prophylaxis of leprosy contacts Institute of Tropical Medicine

Assoumani Younoussa, Said Nourdine Samidine, Auke T Bergeman, Alberto Piubello, Nissad Attoumani, Silahi Halifa Grillone, Sofie Braet, Achilleas Tsoumanis, Abdallah Baco, Aboubacar Mzembaba, et al.

BACKGROUND: Leprosy is an ancient infectious disease with an annual global incidence of around 200,000 over the past decade. Since 2018, the World Health Organization (WHO) recommends single-dose rifampicin as post-exposure prophylaxis (SDR-PEP) for contacts of leprosy patients. The Post ExpOsure Prophylaxis for Leprosy (PEOPLE) trial evaluated PEP with a double dose of rifampicin in Comoros and Madagascar. Preliminary results of this trial ...

Evaluation of artesunate-mefloquine as a novel alternative treatment for schistosomiasis in African children (SchistoSAM): protocol of a proof-of-concept, open-label, two-arm, individually-randomised controlled trial Institute of Tropical Medicine

Clémentine Roucher, Isabel Brosius, Moustapha Mbow, Babacar Thiendella Faye, Annelies De Hondt, Bart Smekens, Diana Arango, Christophe Burm, Achilleas Tsoumanis, Linda Paredis, et al.

INTRODUCTION: Alternative drugs and diagnostics are needed for the treatment and control of schistosomiasis. The exclusive use of praziquantel (PZQ) in mass drug administration programmes may result in the emergence of drug resistance. PZQ has little activity against Schistosoma larvae, thus reinfection remains a problem in high-risk communities. Furthermore, the insufficient sensitivity of conventional microscopy hinders therapeutic response ...

Pain physiology education improves pain beliefs in patients with chronic fatigue syndrome compared with pacing and self-management education: a double-blind randomized controlled trial Ghent University University of Antwerp

Mira Meeus, Jo Nijs, Jessica Van Oosterwijck, Veerle Van Alsenoy, Steven Truijen
Objective: To examine whether pain physiology education was capable of changing pain cognitions and pain thresholds in patients with chronic fatigue syndrome (CFS) and chronic widespread pain. Design: Double-blind randomized controlled trial. Setting: Specialized chronic fatigue clinic in university hospital. Participants: A random sample of patients (N=48) with CFS patients (8 men, 40 women) experiencing chronic pain, randomly allocated to the ...