PT  - JOURNAL ARTICLE
AU  - Maria Svedbo Engström
AU  - Janeth Leksell
AU  - Unn-Britt Johansson
AU  - Sixten Borg
AU  - Bo Palaszewski
AU  - Stefan Franzén
AU  - Soffia Gudbjörnsdottir
AU  - Katarina Eeg-Olofsson
TI  - New Diabetes Questionnaire to add patients’ perspectives to diabetes care for adults with type 1 and type 2 diabetes: nationwide cross-sectional study of construct validity assessing associations with generic health-related quality of life and clinical variables
AID  - 10.1136/bmjopen-2020-038966
DP  - 2020 Nov 01
TA  - BMJ Open
PG  - e038966
VI  - 10
IP  - 11
4099  - http://bmjopen.bmj.com/content/10/11/e038966.short
4100  - http://bmjopen.bmj.com/content/10/11/e038966.full
SO  - BMJ Open2020 Nov 01; 10
AB  - Objectives To study evidence for construct validity, the aim was to describe the outcome from the recently developed Diabetes Questionnaire, assess the associations of that outcome with clinical variables and generic health-related quality of life, and study the sensitivity to differences between clinically relevant groups of glycaemic control in adults with type 1 and type 2 diabetes in a nation-wide setting.Design Cross-sectional survey.Setting Swedish diabetes care clinics connected to the National Diabetes Register (NDR).Participants Among 2479 adults with type 1 diabetes and 2469 with type 2 diabetes selected at random from the NDR, 1373 (55.4%) with type 1 and 1353 (54.8%) with type 2 diabetes chose to participate.Outcome measures The Diabetes Questionnaire, the generic 36-item Short Form version 2 (SF-36v2) health survey and clinical variables.Results Related to the prespecified assumptions, supporting evidence for construct validity for the Diabetes Questionnaire was found. Supporting divergent validity, the statistically significant correlations with the clinical variables were few and weak. In relation to the SF-36v2 and in support of convergent validity, the strongest correlations were seen in the Diabetes Questionnaire scales General Well-being and Mood and Energy. In those scales, machine learning analyses showed that about 40%–45% of the variance was explained by the SF-36v2 results and clinical variables. In multiple regression analyses among three groups with differing levels of glycated haemoglobin adjusted for demographics, other risk factors, and diabetes complications, the high-risk group had, in support of sensitivity to clinically relevant groups, statistically significant lower scores than the well-controlled group in most Diabetes Questionnaire scales.Conclusions This nation-wide study shows that the Diabetes Questionnaire captures some generic health-related quality-of-life dimensions, in addition to adding diabetes-specific information not covered by the SF-36v2 and clinical variables. The Diabetes Questionnaire is also sensitive to differences between clinically relevant groups of glycaemic control.