title: A new self-completion outcome measure for diabetes: is it responsive to change?
abstract: Self-completion instruments assessing subjective health are increasingly being used to measure patient outcome. However, there is very little evidence as yet of existing instruments' responsiveness to change. This paper describes a study to evaluate the responsiveness to change of a self-completion instrument for the measurement of clinical outcome in patients with diabetes. A prospective follow-up study of 48 patients with non-insulin-dependent diabetes commencing insulin therapy was carried out, with assessments at baseline (i.e. pre-intervention), 6 weeks and 3 months post-intervention. The outcome measures used were the changes in scores on the self-completion instrument for symptom level, physical function, energy, depression, psychological distress and barriers to activity, HbA1c, non-fasting serum cholesterol and the body mass index (BMI). There were significant improvements in HbA1c and non-fasting serum cholesterol and worsening of the BMI, as expected. The self-completion instrument detected significant improvements in patient-reported symptoms within 6 weeks of the intervention (p < 0.01) and in energy levels (p < 0.05). There is evidence from this study of the self-completion instrument's ability to respond to change and it has potential for use in evaluative studies.
authors.affiliation: Gateshead and South Tyneside Health Authority, UK.
authors.forename: P
authors.initials: P
authors.lastname: Whitty
authors.forename: N
authors.initials: N
authors.lastname: Steen
authors.forename: M
authors.initials: M
authors.lastname: Eccles
authors.forename: E
authors.initials: E
authors.lastname: McColl
authors.forename: J
authors.initials: J
authors.lastname: Hewison
authors.forename: K
authors.initials: K
authors.lastname: Meadows
authors.forename: Z
authors.initials: Z
authors.lastname: Clapp
authors.forename: A
authors.initials: A
authors.lastname: Hutchinson
mesh_terms: D000368:Aged; D003924:Diabetes Mellitus, Type 2 / Q000534:rehabilitation*; D004739:England; D005260:Female; D005500:Follow-Up Studies; D006306:Health Surveys; D006801:Humans; D008297:Male; D008875:Middle Aged; D011594:Psychometrics; D011788:Quality of Life; D015203:Reproducibility of Results; D016896:Treatment Outcome