Search

OBJECTIVE PANORAMA, a nine-country cross-sectional type 2 diabetes study, investigated factors associated with quality of life (QoL), health status, and other patient-reported outcome measures (PROMs). RESEARCH DESIGN AND METHODS Patients were randomly or consecutively selected from primary/secondary care. PROMs included the Audit of Diabetes-Dependent Quality of Life (ADDQoL) (generic QoL item and average weighted impact [AWI] scores), Diabetes Treatment Satisfaction Questionnaire (DTSQ) (patient- and physician-completed), Hypoglycemia Fear Survey-II worry subscale, and the EuroQoL–5 Dimension visual analog scale (EQ-VAS) measuring patient-reported health. Multivariable linear regression analyses determined predictors of each PROM including patient characteristics, physician-reported adherence, complications, and glycosylated hemoglobin. RESULTS In 5,813 patients, mean PROM scores indicated that generic QoL approximated “good” (0.93); perceived impact of diabetes on QoL was negative (AWI –1.69). Treatment satisfaction exceeded physicians’ estimates (patient-reported: 29.76; physician-estimated: 27.75), but so did patients’ perceived frequency of hypo-/hyperglycemia. Worry about hypoglycemia (13.27) was apparent. Intensifying treatments to three oral agents or insulin regimens predicted worse QoL (AWI P < 0.01). Insulin alone use predicted worse QoL (generic P < 0.02; AWI P < 0.001) and hypoglycemia worry (P < 0.007). No treatment had significant associations with EQ-VAS health status. CONCLUSIONS Predictors for different PROMs differed markedly and provided insights for understanding and improving these important outcomes. Intensive treatment regimens had significant negative associations with all PROMs, except the EQ-VAS health status measure. The findings demonstrate the importance of measuring QoL alongside health status and other patient-reported outcomes when evaluating diabetes treatments with a view to protecting QoL and facilitating adherence and long-term glycemic control.

Objective To compare the effects of continuous subcutaneous insulin infusion (CSII) and conventional insulin therapy (CIT) in patients with poorly controlled sulfonylurea-treated diabetes mellitus. Resarch Design and Methods Twenty-five patients aged 40–65 yr and poorly controlled with sulfonylureas and without severe diabetic complications comprised the study group. Five patients left the study (3 achieved satisfactory glycemic control without insulin, 1 defaulted, 1 developed ketonuria). Ten patients were treated with CSII and 10 with CIT. Outpatient treatment consisted of CIT (twice-daily injections of regular and NPH insulin) or CSII (basal infusion and prandial boluses of regular insulin). Results Glycosylated hemoglobin improved with both methods of insulin delivery (P < 0.01), but 8 of 10 CSII-treated patients achieved satisfactory glycemic control (HbA1 < 50 mmol hydroxymethylfurfural/mol Hb), whereas only 3 of 10 CIT-treated patients achieved this (P < 0.05). Weight gain, insulin dosage, and prevalence of hypoglycemia were similar in the two groups. Retinal deterioration occurred in one CSII-treated patient and three CIT-treated patients, but there were no episodes of infusion site infection or metabolic decompensation. Patients' satisfaction with treatment improved during insulin therapy (P < 0.02), and significant changes in beliefs about diabetes and its treatment were observed in CSII-treated patients (P < 0.05). Concusions Glycemic control improved with both methods of insulin treated patients achieved satisfactory glycemic control (HbA1 < 50 mmol hydroxymethylfurfural?mol Hb), whereas only 3 of 10 CIT-treated patients achieved this CSII. Patients' satisfaction with treatment improved during insulin therapy.

The advantages and limitations of RCT designs are discussed, and a range of alternative designs for medical and educational intervention studies considered. Designs selected are those that address the much neglected psychological issues involved in the recruitment of patients and allocation of patients to treatments within trials. Designs include Zelen's (18) randomized consent design, Brewin and Bradley's (20) partially randomized patient-centered design, and Korn and Baumrind's (21) partially randomized clinician-centered design. The possibilities of combining features from each of the last two designs are illustrated, and the advantages of adopting a more flexible and clinically relevant approach to the design of clinical trials are discussed.