The MCQ was developed and tested in a comprehensive three stage process:
Stage 1 – Item generation.
Semi-structured, in-depth interviews were carried out with 23 people recently diagnosed with MCI. A set of preliminary questionnaire items were then discussed with an expert panel and refined to produce a draft questionnaire. The draft questionnaire was then discussed with a focus group of 11 people with MCI resulting in a final draft 17-itme questionnaire.
Stage 2 – Item reduction and scale generation.
A first postal study (n=280, resulting in 146 completed questionnaires) was conducted using the 17 item questionnaire generated at stage one, along with the SF-12 v2 (Mental Health Component Summary Score (MCS) and Physical Component Summary Score (PCS)). The resulting data was analysed to identify any issues with items measuring the same concept and assess internal consistency (using Cronbach’s alpha) of each domain. Construct validity of the MCQ was examined by correlation with the SF12 results. Four items were removed because of floor effects. Factor analysis identified two domains of Emotional Effects (irritation/frustration, anxiety, low mood, concern about the future, worry about the reactions of others and worry that their memory problems) and Practical Concerns (worry about: having forgotten things e.g. names, plans or appointments, problems with conversation due to memory difficulties, feeling generally ‘slowed down’ or less independent and concern about upsetting others).
Stage 3 – Testing validity.
The construct validity of the MCQ was examined by correlation with the SF-12v2 MCS and PCS and shown to be adequately correlated.
Further information on the design, development and testing of the MCQ is available in the development paper – see key references. The methods used to develop the MCQ were adopted as they have been shown to be effective in the development of similar questionnaires in the past and in many areas are compliant with FDA guidance in the development of PRO measures.
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