Interviewing to develop Patient-Reported Outcome (PRO) measures for clinical research: eliciting patients’ experience

Abstract

Patient-reported outcome (PRO) measures must provide evidence that their development followed a rigorous process for ensuring their content validity. To this end, the collection of data is performed through qualitative interviews that allow for the elicitation of in-depth spontaneous reports of the patients’ experiences with their condition and/or its treatment. This paper provides a review of qualitative research applied to PRO measure development. A clear definition of what is a qualitative research interview is given as well as information about the form and content of qualitative interviews required for developing PRO measures. Particular attention is paid to the description of interviewing approaches (e.g., semi-structured and in-depth interviews, individual vs. focus group interviews). Information about how to get prepared for a qualitative interview is provided with the description of how to develop discussion guides for exploratory or cognitive interviews. Interviewing patients to obtain knowledge regarding their illness experience requires interpersonal and communication skills to facilitate patients’ expression. Those skills are described in details, as well as the skills needed to facilitate focus groups and to interview children, adolescents and the elderly. Special attention is also given to quality assurance and interview training. The paper ends on ethical considerations since interviewing for the development of PROs is performed in a context of illness and vulnerability. Therefore, it is all the more important that, in addition to soliciting informed consent, respectful interactions be ensured throughout the interview process.

Content Validity of the Lee Chronic Graft-versus-Host Disease Symptom Scale as Assessed by Cognitive Interviews

“…Loss of sleep- I don’t have loss of sleep so I just marked zero on them but I take it they’re all common symptoms of GVHD. I just don’t have all of them” (13). …”

“…How would you know what the end of the scale is if you haven’t experienced it so you don’t know really where you are on the scale. But if you say not at all or slightly or moderately, I think that’s easier to answer those questions” (13). …”

“…The scripted, cognitive interview was based on a framework developed by the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) for evaluating existing PRO instruments and their measures [11–13]. Interview questions and follow-up probes were based on the principles of cognitive interviewing articulated by Willis [14].…”

A systematic review of patient reported outcome measures (PROMs) used in child and adolescent burn research

“…Increasingly researchers have highlighted the importance of conducting qualitative research with patients when developing PROMs, in order to ensure that the items are well understood, wide-ranging and appropriately reflect the experiences of the specified population [78]. Guidance offered by the Scientific Advisory Committee of the Medical Outcomes Trust [22] and Cano et al [21] indicate that patient interviews are an important information source when generating items during the development of a PROM.…”

Towards a core outcome set for hemorrhoidal disease—a systematic review of outcomes reported in literature

“…The importance of engaging patients in research is being increasingly recognized [44–46]. By asking patients which outcomes should be assessed, we can be confident that treatment interventions are investigated in a way that is relevant to the target population.…”