Validation of a questionnaire to assess side effects
Research type
Research Study
Full title
Validation of a questionnaire to assess side effects in diabetes
IRAS ID
149196
Contact name
Patrick Mark
Contact email
Sponsor organisation
Academic research coordinator NHS GGC
Research summary
This study aims to validate the English version of a questionnaire assessing side-effects reported by patients. The questionnaire contains 2 parts (part A + B) to identify side-effects and further characterise them. The questionnaire has been designed by a research group in Holland, where the Dutch version has been validated. In the current study, the English version will be validated. The overall aim is to develop a validated tool for assessing side-effects in clinical trials and/or observational studies. In the current study, patients with type 2 diabetes will be asked to complete the questionnaire after which an interview will be conducted. In addition, patients are asked to rephrase a selected sample of side-effects from the questionnaire to assess whether the side-effects are interpreted as intended. The interview will be recorded and transcribed verbatim by the researcher. Two researchers will review these transcribed interviews to identify relevant problems in the questionnaires. Changes to the questionnaire will be made in an iterative process until no new pertinent problems are detected and two researchers agree that the questionnaire is sufficiently valid.
REC name
West of Scotland REC 3
REC reference
14/WS/1095
Date of REC Opinion
19 Sep 2014
REC opinion
Further Information Favourable Opinion