Protocol for Assessing Content Validity in Generic Preference-weighted Measures: A Scoping Review

Objective: The objectives of this scoping review are to: (i) identify, extract and synthesise methodological characteristics and key findings of contemporary qualitative studies assessing content validity in generic adult and paediatric preference-weighted measures (PWMs); (ii) map the methodological characteristics identified against good practice guidance to identify examples of good practice, any gaps and generate suggestions for future work; and (iii) interpret and critically reflect on the mapping exercise and best practice recommendations, to assess which recommendations should be considered applicable to the assessment of generic PWMs and in what form.Introduction: Content validity is considered a fundamental measurement property. While guidance exists for assessing content validity of patient reported outcome measures (PROMs) as a whole, there is no best practice guidance for assessing content validity of generic PWMs, which represent a ‘special case’ of PROMs. This may lead to suboptimal study design or inaccurate conclusions that generic PWMs do not have satisfactory content validity in particular health conditions.Inclusion criteria: Included articles will consist of full-text manuscripts in English describing qualitative research assessing at least one aspect of content validity of generic adult or paediatric PWMs. Manuscripts can involve participants in any setting/country.Methods: Eight databases (MEDLINE, Embase, CINAHL, PsycINFO, Science and Social Sciences Citation Indexes, Econlit, Tufts CEA Registry, and MATHSCINET) will be searched. Contemporary qualitative content validity studies in generic adult and paediatric PWMs will be included and relevant data extracted. A descriptive narrative synthesis will be conducted mapping content validity studies onto existing guidance and appraised in the context of the unique challenges that exist in assessing content validity in generic PWMs.