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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 Universiteit Hasselt

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 ...

"Great powers and great responsibilities": A brief comment on "A brief mobile app reduces nonsuicidal and suicidal self-injury: Evidence from three randomized controlled trials" (Franklin et al., 2016) KU Leuven

Olivia Kirtley
Online and mobile mental health applications (apps) herald exciting new opportunities for the treatment and prevention of self-injurious thoughts and behaviors (SITBs). With such rapid technological advances, it is paramount that health care innovation not be achieved to the detriment of intervention quality. Franklin et al.'s (2016) therapeutic evaluative conditioning (TEC) app is a novel and timely addition to the mobile health landscape; ...

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 Universiteit Hasselt

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 Instituut voor Tropische Geneeskunde

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 Instituut voor Tropische Geneeskunde

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 ...

Catheter ablation in patients with paroxysmal atrial fibrillation and absence of structural heart disease: A meta-analysis of randomized trials Vrije Universiteit Brussel

Antonio Parlavecchio, Giampolo Vetta, Giovanni Coluccia, Lorenzo Pistelli, Rodolfo Caminiti, Manuela Ajello, Michele Magnocavallo, Giuseppe Dattilo, Rosario Foti, Scipione Carerj, et al.
Introduction: Rhythm control strategy in paroxysmal atrial fibrillation (AF) can be performed with antiarrhythmic drugs (AAD) or catheter ablation (CA). Nevertheless, a clear overview of the percentage of freedom from AF over time and complications is lacking. Therefore, we conducted a meta-analysis of randomized controlled trials (RCTs) comparing CA versus AAD. Methods: We searched databases up to 5 May 2023 for RCTs focusing on CA versus AAD. ...

Prevention and Therapy of Alcohol Withdrawal on Intensive Care Units: Systematic Review of Controlled Trials KU Leuven

Liviu Ungur
BACKGROUND: Alcohol withdrawal syndrome (AWS) occurs in 16 to 31% of intensive care unit (ICU) patients after cessation of sedation. There exist many preventive and therapeutic strategies, but no systematic review (SR) has been published on this topic so far. We aimed to perform a synopsis of all controlled trials of AWS prevention and therapy in ICU published between 1971 and 30 March 2011 following the "Preferred Reporting Items for Systematic ...