Patient-relevant outcomes in randomized controlled trials of technology-based psychological interventions for depression – findings from a systematic review with active patient involvement

Article type
Authors
Köhnen M1, Kriston L1, Härter M1, Liebherz S1
1Department of Medical Psychology, University Medical Center Hamburg-Eppendorf
Abstract
Background: randomized controlled trials (RCTs) are essential to assess the effectiveness, acceptance and safety of health care interventions. However, the majority of RCTs is conducted without patient and public involvement, thus important outcomes from a patient perspective may be neglected.

Objectives: to identify patient-relevant outcomes (via patient involvement in a systematic review) and to assess reporting practices regarding patient-relevant outcomes in included RCTs.

Methods: at the beginning of our systematic review, a workshop involving patients and their relatives (n = 13) took place to provide general information on systematic reviews and technology-based psychological interventions and to discuss the most important outcomes from their perspective. Two independent raters categorized mentions of the workshop to outcome categories, which we will use to describe if and how those categories were reported in included studies of the systematic review. We resolved discrepancies during categorization by discussion.

Results: we subsumed mentions (n = 25) to outcome categories (n = 11): symptom reduction, sleep quality, adverse events, quality of life, understanding of illness, coping with everyday life, self-efficacy/hope, destigmatization, subjective sense of the disease, dealing with emotions and understanding of underlying causes.

Discussion: assessing reporting practices on patient-relevant outcomes in a systematic review may help to identify research gaps from a perspective considering people with experiences. In regard of identified outcome categories, we assume that merely symptom reduction, quality of life and adverse events will be reported by default.

Patient or healthcare consumer involvement: we involved patients and their relatives in the context of a workshop by providing general information on systematic reviews and on the intervention of interest and to discuss the most important outcomes from their perspective. Additionally, we will conduct a second workshop at the end of the project to discuss the results, the plain language summary and dissemination strategies for a lay audience.