Recording harms in randomized controlled trials of behavior change interventions: a scoping review and map of the evidence

Papaioannou, Diana; Hamer-Kiwacz, Sienna; Mooney, Cara; Cooper, Cindy; O'Cathain, Alicia; Sprange, Kirsty; Moody, Gwenllian

doi:10.1016/j.jclinepi.2024.111275

All Outputs (5)

Current usage of explainer animations in trials: a survey of the UKCRC registered clinical trial units in the UK (2024)
Journal Article

Background: Explainer animations are a means to communicate aspects of clinical trials to participants in a more engaging and accessible way. Delivered well these have the potential to enhance recruitment and retention. The range of media technology... Read More about Current usage of explainer animations in trials: a survey of the UKCRC registered clinical trial units in the UK.

Precision computerised cognitive behavioural therapy (cCBT) for adolescents with depression: a pilot and feasibility randomised controlled trial protocol for SPARX-UK (2024)
Journal Article

Background : A serious game called SPARX (Smart, Positive, Active, Realistic, X-factor thoughts), originally developed in New Zealand and incorporating cognitive behavioural therapy (CBT) principles, has been shown to help reduce symptoms of depressi... Read More about Precision computerised cognitive behavioural therapy (cCBT) for adolescents with depression: a pilot and feasibility randomised controlled trial protocol for SPARX-UK.

Choosing and evaluating randomisation methods in clinical trials: a qualitative study (2024)
Journal Article

Background: There exist many different methods of allocating participants to treatment groups during a randomised controlled trial. Although there is research that explores trial characteristics that are associated with the choice of method, there is... Read More about Choosing and evaluating randomisation methods in clinical trials: a qualitative study.

Recording harms in randomised controlled trials of behaviour change interventions: a qualitative study of UK clinical trials units and NIHR trial investigators (2024)
Journal Article

Background: Harms, also known as adverse events (AEs), are recorded and monitored in randomised controlled trials (RCTs) to ensure participants’ safety. Harms are recorded poorly or inconsistently in RCTs of Behaviour Change Interventions (BCI); howe... Read More about Recording harms in randomised controlled trials of behaviour change interventions: a qualitative study of UK clinical trials units and NIHR trial investigators.

Recording harms in randomized controlled trials of behavior change interventions: a scoping review and map of the evidence (2024)
Journal Article

Objectives: Randomized controlled trials evaluate diverse interventions. This can include medical interventions such as drugs or surgical procedures, or behavior change interventions (BCIs) that aim to change a habit, belief, or attitude to improve h... Read More about Recording harms in randomized controlled trials of behavior change interventions: a scoping review and map of the evidence.