Process evaluation of complex cardiovascular interventions: How to interpret the results of my trial?

Abstract

Complex interventions of varying degrees of complexity are commonly used and evaluated in cardiovascular nursing and allied professions. Such interventions are increasingly tested using randomized trial designs. However, process evaluations are seldom used to better understand the results of these trials. Process evaluation aims to understand how complex interventions create change by evaluating implementation, mechanisms of impact, and the surrounding context when delivering an intervention. As such, this method can illuminate important mechanisms and clarify variation in results. In this article, process evaluation is described according to the Medical Research Council guidance and its use exemplified through a randomized controlled trial evaluating the effectiveness of a transition program for adolescents with chronic conditions.

Technology Acceptance of Home-Based Cardiac Telerehabilitation Programs in Patients With Coronary Heart Disease: Systematic Scoping Review

“…A recent systematic review and meta-analysis [ 7 ] of randomized controlled trials comparing home-based cardiac telerehabilitation to center-based cardiac rehabilitation in patients with coronary heart disease found equivalent effects on functional capacity, cardiac-related hospitalization, physiological risk factor control, quality of life, depression, and behaviors such as physical activity, smoking cessation, and medication adherence. However, adapting digital solutions for health problems is not without its challenges; attempts to scale up effective digital health research interventions into real-world health care systems have been met with difficulty, especially for complex interventions that require user interaction [ 8 , 9 ]. The successful incorporation of such digital health technologies into clinical practice is contingent upon end-users’ (ie, patients) acceptance and sustained engagement with the intervention, and thus, these are important aspect for researchers, health care systems, and policymakers to consider [ 9 , 10 ].…”

One year of methods corner: the way forward to innovate research in cardiovascular care

“…In the first year of the Methods Corner, seven papers have been published. [4][5][6][7][8][9][10] Six of these articles addressed quantitative research techniques. 4,5,[7][8][9][10] In the January 2020 issue, propensity weighting was discussed.…”

“…There was one non-technical paper, discussing how process evaluations of complex healthcare interventions can be performed. 6 This contribution was published in the March 2020 issue. Process evaluations help to understand how complex interventions create change by evaluating implementation, mechanisms of impact, and the surrounding context when delivering the intervention.…”

“…Process evaluations help to understand how complex interventions create change by evaluating implementation, mechanisms of impact, and the surrounding context when delivering the intervention. 6 Hence, process evaluation can illuminate important mechanisms and clarify variation in results of trials. 6 From inception and moving forward, it is the ambition of the editors to have a fair balance of technical and non-technical contributions.…”

“…6 Hence, process evaluation can illuminate important mechanisms and clarify variation in results of trials. 6 From inception and moving forward, it is the ambition of the editors to have a fair balance of technical and non-technical contributions. For instance, topics that will be addressed in the Methods Corner in 2021 are: flash mob research; 12 grounded theory, mixed methods, item response theory, methods to be used when evaluating mHealth, and methodological challenges related to doing research in octogenarians.…”