Accepted for/Published in: JMIR Formative Research
Date Submitted: Dec 4, 2020
Date Accepted: May 2, 2021
Date Submitted to PubMed: Aug 26, 2021
Conducting digital healthcare research: A document analysis of challenges experienced during intervention development and feasibility study set-up of an internet-administered intervention for parents of children treated for cancer
ABSTRACT
Background:
The design and conduct of research to develop, test, and evaluate complex healthcare interventions is challenging. Whilst there is existing literature describing 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. Further, literature is scarce concerning the challenges associated with development and feasibility studies utilizing internet-based technologies for both intervention delivery and the execution of trial procedures.
Objective:
To describe the challenges faced in: (1) the development of an internet-administered low-intensity CBT intervention for parents of children treated for cancer, with a specific focus on the technical development phase of the intervention and features to support the execution of the ENGAGE feasibility study, and (2) the concurrent set-up of the ENGAGE feasibility study.
Methods:
A document analysis, guided by a thematic analysis approach, was adopted. Discussion groups with members of the research team were held to develop a more detailed understanding of challenges encountered. 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 ENGAGE feasibility study. Implications are discussed to inform the future design, conduct, and planning of intervention development and feasibility studies, especially those utilizing internet-based technologies for intervention delivery and execution of trial procedures. Clinical Trial: ISRCTN 57233429; ISRCTN 18404129
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