Recommendations on recording harms in randomised controlled trials of behaviour change interventions.

Harms are possible from behaviour change interventions, such as the worsening of a health behaviour intended for change (rebound effect), improving a health behaviour but with subsequent worsening of another behaviour (risk compensation), and participants feeling targeted or stigmatised by an intervention. The processes and definitions originally designed to record harms within drug trials are typically followed to record harms in trials of behaviour change interventions owing to the lack of alternative guidance. Therefore, important harms could be missed in the evaluations of behaviour change interventions or irrelevant harms data may be recorded, leading to inefficiency.

Barriers and facilitators to faecal immunochemical testing in symptomatic populations: A rapid systematic scoping review and gap analysis.

Aim: Faecal immunochemical testing (FIT) is used to triage people with signs or symptoms of a colorectal cancer (CRC). Recent guidelines have recommended further research to improve access, uptake and return of FIT. This systematic scoping review aims to understand the barriers and facilitators to FIT testing in symptomatic patients.

Flexor Injury Rehabilitation Splint Trial (FIRST): protocol for a pragmatic randomised controlled trial comparing three splints for finger flexor tendon repairs.

Background: Without surgical repair, flexor tendon injuries do not heal and patients' ability to bend fingers and grip objects is impaired. However, flexor tendon repair surgery also requires optimal rehabilitation. There are currently three custom-made splints used in the rehabilitation of zone I/II flexor tendon repairs, each with different assumed harm/benefit profiles: the dorsal forearm and hand-based splint (long), the Manchester short splint (short), and the relative motion flexion splint (mini).

Recording harms in randomised controlled trials of behaviour change interventions: a qualitative study of UK clinical trials units and NIHR trial investigators.

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); however, limited guidance exists on how to record harms in BCI trials. This qualitative study explored experiences and perspectives from multi-disciplinary trial experts on recording harms in BCI trials.

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

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 health, for example, healthy eating, psychological wellbeing. Harms are often recorded poorly or inconsistently within randomized controlled trials of BCIs.