Development and content validity of the Clinal Needs Assessment for Myalgic Encephalomyelitis (CNAME)

PurposeTo co-produce the Clinical Needs Assessment for Myalgic Encephalomyelitis (CNAME) with patients and clinicians, and to assess its content validity. MethodsGuided 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) were assessed using frequencies, cross-tabulations and response rates respectively. As the CNAME produces dichotomous (yes/no/not relevant) data which are not summated and is not intended for repeated use further psychometric analyses are not possible or relevant. ResultsFour 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. ConclusionsThe Clinical Needs Assessment for ME is a valid, feasible and acceptable measure of people with ME/CFS clinical needs.