Examining and interpreting responsiveness of the Diabetes Medication Satisfaction measure.
OBJECTIVE
Treatment satisfaction (TS) is an important patient reported outcome (PRO) in diabetes as it is correlated with outcomes necessary for optimal treatment (e.g., compliance, self-management behaviour). The objective of this study was to examine the responsiveness of the DiabMedSat, a disease-specific PRO measure, assessing Overall, Burden, Efficacy and Symptom TS.


METHODS
The DiabMedSat was included in an open label, observational study of the safety and efficacy of biphasic insulin aspart 30 (NovoMix 30) in routine practice with type 2 diabetes. Responsiveness analyses, examining both internal and external responsiveness, were conducted and minimally important differences (MID) assessed.


RESULTS
In 18,817 patients, all TS scores significantly improved after 26 weeks of treatment (p<0.001). The effect sizes for these changes were above 0.5 indicating that the ability to detect change was moderate-to-large in size. Significant differences were found for all TS scores comparing patients who met their HbA(1c) goal, who improved but did not meet goal and who did not improve (p<0.01), and for patients who experienced a minor hypoglycaemic event and those who did not (p<0.001). DiabMedSat scores were able to detect changes in patients' own global rating of satisfaction (MID ranging from 5.3 to 11.7) and in physician-rated satisfaction with patients' HbA(1c) improvement (MID ranging from 5.3 to 10.2).


CONCLUSIONS
In the context of an observational study, the DiabMedSat has been shown to be highly responsive to change and can be considered as an acceptable PRO measure for TS in diabetes.
Brod
Meryl
M
The Brod Group, 219 Julia Avenue, Mill Valley, CA 94941, USA. mbrod@thebrodgroup.net
Christensen
Torsten
T
Kongsø
Jens Harald
JH
Bushnell
Donald M
DM
D001291:Attitude of Health Personnel; D061265:Biphasic Insulins; D001786:Blood Glucose / Q000187:drug effects; D003924:Diabetes Mellitus, Type 2 / Q000097:blood / Q000188:drug therapy*; D005260:Female; D006801:Humans; D007004:Hypoglycemic Agents / Q000008:administration & dosage*; D007328:Insulin / Q000008:administration & dosage / Q000031:analogs & derivatives*; D061267:Insulin Aspart; D007336:Insulin, Isophane; D008137:Longitudinal Studies; D008297:Male; D008875:Middle Aged; D015337:Multicenter Studies as Topic; D017060:Patient Satisfaction; D012648:Self Care / Q000523:psychology; D016896:Treatment Outcome; D015431:Weight Loss / Q000187:drug effects
D061265:Biphasic Insulins; D001786:Blood Glucose; D007004:Hypoglycemic Agents; D007328:Insulin; C557564:insulin aspart, insulin aspart protamine drug combination 30:70; D007336:Insulin, Isophane; D061267:Insulin Aspart