Background and aims
The Standard Protocol Items: Recommendations for Interventional Trials – patient-reported outcome (SPIRIT-PRO) extension requires trial protocols to justify selection of patient-reported outcome measures (PROMs) and hypothesise expected effects. Ideally, the rationale for PROM selection should be supported by a conceptual framework, which provides a theoretical basis to ensuring the trial measures what matters most to patients. However, many protocols default to a standard set of widely-used PROMs, resulting in important outcomes being missed, unnecessary respondent burden, and difficulty interpreting findings.
The Cancer Quality of Life Expert Service Team (CQUEST) has developed a resource to help investigators establish a conceptual framework and associated measurement model for their trial protocol.
Methods
The conceptual framework resource will be available on the CQUEST website, and will outline the definition of a conceptual framework, its rationale, and a step-by-step guide on developing a framework. A template will also be available for investigators to create their own framework, which can then be inserted into a study protocol. The poster/oral presentation will include an exemplary framework to aid TROG members in contextualising its utility and application within a cancer clinical trial setting.
The authors of SPIRIT-PRO will be involved to provide consensus on this resource.
Results
TROG investigators are invited to utilise the conceptual framework template to inform PROM selection in their trials. CQUEST can collaboratively build this with investigators and then assist with the choice of PROMs after key concepts of interest have been identified. The framework template is adaptable to various trial settings, thereby addressing the diverse needs of cancer clinical trials and other study types involving PROMs.
Conclusion
CQUEST invites TROG members to engage with our conceptual framework resource to facilitate thoughtful selection of PROMs in cancer clinical trials, so as to directly address the trial objectives and yield results optimally informative to stakeholder needs.