The ACTS was developed based on the original conceptual model of the Duke Anticoagulation Satisfaction Scale (DASS) following a literature review, interviews with experts and patients, and qualitative cognitive debriefing interviews [ 10- 12].
Based on the above premises, particularly the FDA PRO Guidance [11], traditional hypothesis-generating concept-elicitation interviews were not executed but were exchanged instead with qualitative cognitive-debriefing interviews to document that patients could understand the NVSA© instructions, items, and response scales and could easily comprehend and meaningfully respond to the NVSA© items.
ŁW MF conducted qualitative study, cognitive debriefing and developed the questionnaire, MF, GB, MS JZ WP conducted psychometric study, GB, ŁW, MS were responsible for statistical analysis.
Incorporating debriefing or qualitative interviews as part of CBC exercise may provide insights into sources of dominant or lexicographic preferences.
A supervisor trained in qualitative methods conducted daily debriefing sessions with all data collectors to discuss key findings, identify saturation of themes, and refine lines of inquiry.
With respect to b) peer debriefing, a qualitative research expert checked that the data and interpretation were coherent and audited the study process.
Based on literature reviews, a previous qualitative study and cognitive debriefing interviews, and in consultation with an expert panel, a 45-item (pregnancy) and a 49-item (postnatal) self-report questionnaire were designed, enabling assessment of important psychosocial issues for women with T1DM during pregnancy and in the immediate postnatal period.
Glossary of Terms: Cognitive debrief: a qualitative research tool used to determine whether concepts and items are understood by patients in the same way that instrument developers intend.
Current approaches suggest the employment of quantitative (e.g. factor analysis) and qualitative (e.g. patient debriefing questionnaires and patient panels) techniques.
