In order to document the development and refinement of each item in the NiSCI, an item-tracking matrix was developed including information about the development of the item, changes made following translatability assessment, changes following the first round of cognitive interviews, and the final version of items (Version 2) following the second round of interviews.
Patients with osteoarthritis in the knee were involved during the development of the item inventory of the index in order to assess clinical relevance [ 26].
JP participated in the design of the study, advised on development of the item pool, reviewed the statistical analysis, helped interpret the data and draft the manuscript.
An advantage of the present methodology relates to the potential use of participants own language in the development of the item wording for a new questionnaire.
After development of the item banks, the second stage involved another group of 133 patients completing the item banks (items determined after Rasch analysis) under a CAT version and by 'paper and pencil'.
Our aim was to build a CAT based on the perspective of patients, so in the development of the item bank [ 16], the optimal balance between both perspectives – psychometric results and information gained from patients' experience – remained our goal.
Development of the item list followed the approach of the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Group that is currently developing item banks for a range of patient-reported outcome domains relevant to cancer patients [ 9- 11].
Following development of the item pool, the items were formatted as Version 1 of the PRO instrument, administered to patients, and tested in one-on-one cognitive interviews to further confirm the content validity of the instrument.
Development of the item pool was based on an iterative process involving review of the historical and contemporary literature in the refugee field in general, and in relation to West Papua in particular.
The development of the item content for the TRIM Diabetes/Device began in 2002 with the development of the TRIAD Measures (The Diabetes Symptom Measure (DSM), Diabetes Productivity Measure (DPM) and the Diabetes Medication Satisfaction Measure (DiabMedSat)) for oral agents and injectable treatments (syringe and pen) for type 1 and 2 diabetes [ 2].
