A qualitative study of cancer clinical trial network consumers' acceptability of the modular approach to patient-reported outcome measurement: how much of it is "common sense"?

backgroundThere is growing interest in customising patient-reported outcome measures (PROMs). This involves selecting specific domains (i.e., subscales) that focus on key health-related quality of life (HRQoL) issues most relevant to a particular study's context, referred to as the modular approach. Despite available recommendations from international stakeholders and PROM developers, the modular approach has not been widely adopted in cancer clinical trials. This qualitative study explored the acceptability of the modular approach to administering PROMs from the perspectives of cancer consumers.

methodsConsumers (patients, family members and/or caregivers) who have experience with cancer were recruited through cancer clinical trial networks in Australian and New Zealand. Data were collected through online focus groups. Interview probes and analysis were guided by Sekhon et al.'s Theoretical Framework of Acceptability.

resultsTen consumers, all with prior experience in clinical trial design, participated across four focus groups. The acceptability of the modular approach was discussed in reference to four themes: (1) minimising respondent burden is not simply about shortening PROMs; (2) competing priorities of reducing burden, preserving PROM measurement properties and assessing breadth versus depth of issues; (3) new strategies are needed to improve PROM relevance; and (4) who should select the domains, and how? Acceptable features of the modular approach included its potential to increase the relevance of questions, minimise duplication, and allow for more in-depth assessment of priority HRQoL issues. Participants also believed that involving consumer representatives in domain selection could alleviate the burden on researchers during trial design and were supportive of giving individual clinical trial patients the option to self-select domains that are personally meaningful.

conclusionsConsumers were generally supportive of using the modular approach in administering PROMs in clinical trials, while also identifying ways to strengthen its acceptability. These included the need for clearer consensus and guidance on what constitutes a well-justified selection of domains and further personalisation of PROM domains (e.g., through branching questions). These insights can help inform regulatory agencies and other stakeholders about consumer needs and highlight the support needed if there is to be a paradigm shift in trial design towards tailored PROM administration.