TY - JOUR

T1 - Rating the importance of outcomes from diabetes trials

T2 - A survey of patients' and doctors' opinions

AU - Yahyavi, Sam Kafai

AU - Kristensen, Peter Lommer

AU - Nagras, Zainab Gassem

AU - Hjorthøj, Carsten

AU - Krogh, Jesper

PY - 2022

Y1 - 2022

N2 - PurposeTo investigate and compare how patients with diabetes mellitus and doctors rate the importance of outcomes used as part of composite endpoints in clinical diabetes trials. Secondly, to compare the ratings of outcomes between patients with low and high education.MethodsUsing a pre-piloted questionnaire, patients with diabetes and doctors working with diabetes were asked to rate the importance of 36 different outcomes commonly used in trials assessing intervention effects in patients with diabetes. The respondents were asked to rate individual outcomes as being either critical, of major importance, of moderate importance, or of minor importance.ResultsThe study population consisted of 139 patients with a mean age of 56.6 years and an average duration of diabetes for 13.6 years and 45 doctors with a mean time of practice of 19.6 years. There was no difference between patients’ and doctors’ rating of risk of mortality and non-fatal myocardial infarction, and percutaneous coronary intervention (all p-values > 0.34). Non-fatal stroke, admission for heart failure or angina was perceived more severely by patients compared to doctors (all p-values < 0.03). Patients rated risk of foot-ulcers, amputations and quality of life as more important compared to doctors (p-values < 0.01).ConclusionThe current study suggest that patients and doctors weigh some diabetic outcomes used as part of composite endpoints in clinical diabetes trials differently. These findings call for more studies on patient reported outcomes and patient education for improved personal care.

AB - PurposeTo investigate and compare how patients with diabetes mellitus and doctors rate the importance of outcomes used as part of composite endpoints in clinical diabetes trials. Secondly, to compare the ratings of outcomes between patients with low and high education.MethodsUsing a pre-piloted questionnaire, patients with diabetes and doctors working with diabetes were asked to rate the importance of 36 different outcomes commonly used in trials assessing intervention effects in patients with diabetes. The respondents were asked to rate individual outcomes as being either critical, of major importance, of moderate importance, or of minor importance.ResultsThe study population consisted of 139 patients with a mean age of 56.6 years and an average duration of diabetes for 13.6 years and 45 doctors with a mean time of practice of 19.6 years. There was no difference between patients’ and doctors’ rating of risk of mortality and non-fatal myocardial infarction, and percutaneous coronary intervention (all p-values > 0.34). Non-fatal stroke, admission for heart failure or angina was perceived more severely by patients compared to doctors (all p-values < 0.03). Patients rated risk of foot-ulcers, amputations and quality of life as more important compared to doctors (p-values < 0.01).ConclusionThe current study suggest that patients and doctors weigh some diabetic outcomes used as part of composite endpoints in clinical diabetes trials differently. These findings call for more studies on patient reported outcomes and patient education for improved personal care.

KW - Clinical trials

KW - Education

KW - Macrovascular disease

KW - Microvascular disease

KW - Other complications

U2 - 10.1007/s40200-021-00934-9

DO - 10.1007/s40200-021-00934-9

M3 - Journal article

C2 - 35673504

VL - 21

SP - 51

EP - 59

JO - Journal of Diabetes and Metabolic Disorders

JF - Journal of Diabetes and Metabolic Disorders

SN - 2251-6581

ER -