Abstract
ABSTRACT
Background
To co‐produce the Clinical Needs Assessment for Myalgic Encephalomyelitis (CNAME) with patients and clinicians, and to assess its content validity.
Methods
Guided by the COSMIN guidelines, a draft CNAME was devised from relevant literature and lived experience. It was revised following piloting and cognitive interviews with the advisory groups and then completed online by people with ME. Content and face validity were assessed via deductive framework analysis of participants’ feedback. Construct validity (in terms of relevance, duplication and comprehensibility) was assessed using frequencies, cross‐tabulations and response rates, respectively. As the CNAME produces dichotomous (yes/no or not relevant) data, which are not summated and are not intended for repeated use, further psychometric analyses are not possible or relevant.
Results
Four hundred people with ME participated. Comprehensibility was excellent (> 97.5% item completion rate). There were no floor effects, but several items had a ceiling effect and were removed. Eight items demonstrated duplication and were combined. Participant feedback was positive, confirming that the CNAME addressed the issues that were important and relevant to them and was easy to complete.
Conclusions
The Clinical Needs Assessment for ME is a valid, feasible and acceptable measure of people with ME/CFS’ clinical needs.
Patient and Public Contribution
Development of the CNAME was a patient‐led project (both the authors live with ME/CFS) and it was co‐produced by people with ME/CFS and clinicians working in NHS specialist ME/CFS services. People with ME/CFS and clinicians were involved in all stages of the study—conceptualisation, design, conduct, analysis, interpretation and dissemination.