Conducting Digital Health Care Research: Document Analysis of Challenges Experienced During Intervention Development and Feasibility Study Setup of an Internet-Administered Intervention for Parents of Children Treated for Cancer

摘要

BACKGROUND:The design and conduct of research to develop, test, and evaluate complex healthcare interventions is challenging. Whilst existing literature describes key challenges associated with the design and conduct of definitive (evaluation) trials, there is a lack of information concerning specific challenges associated with the intervention development phase and set-up of feasibility studies. In particular, literature is scarce concerning the challenges associated with conducting digital healthcare research, for example, research on internet-administered interventions and research utilizing digital features to support the execution of study procedures (for example, recruitment, consent, retention, and data collection and management). This study is conducted in the context of the intervention development and feasibility study set-up phases of an internet-administered, guided, low-intensity Cognitive-Behavioral Therapy (LICBT) based intervention for parents of children previously treated for cancer.OBJECTIVE:To explore the challenges experienced during: (1) the development phase of the internet-administered intervention and digital features to support the execution of the study procedures; and (2) feasibility study set-up.METHODS:To explore the key challenges experienced, we conducted a document analysis of written records from all study meetings held by the research team (meeting minutes) between 7th June 2018 and 10th January 2020, guided by a thematic analysis approach. Further, discussion groups with members of the research team were held to develop a more detailed understanding of the key challenges experienced. Methods and results are reported in accordance with relevant items from the Standards for Reporting Qualitative Research (SRQR) checklist.RESULTS:Six main themes were identified: decision-making and communication; expertise; external constraints; flexibility; planning and scheduling; and technical constraints.CONCLUSIONS:Significant challenges were experienced during the intervention development and set-up phases of the feasibility study. Implications are discussed to inform the future design, conduct, and planning of internet-administered intervention development and feasibility studies, especially within the context of digital healthcare research.