Examining the psychometric properties of the Swedish version of Clinical Outcomes in Routine Evaluation–Outcome Measure (CORE-OM) in a clinical sample using classical test theory and item response theory

The aim of this study was to examine the psychometric properties of the Swedish version of the Clinical Outcomes in Routine Evaluation–Outcome Measure (CORE-OM) using classical test theory and item response theory (IRT). The CORE-OM is a commonly used 34-item self-report instrument measuring psychological problems/distress covering four domains: subjective well-being, problems/symptoms, functioning and risk. Despite its broad application, only a few studies have used IRT to examine the psychometric properties, and the properties of the Swedish version have only been examined in one initial study. The present study included 1,011 clients with mild to moderate symptoms of distress, applying for psychotherapy at an outpatient training clinic in Sweden. Clients' responses were subjected to classical item analyses as well as IRT (Rasch) analysis using the partial credit model. The classical analyses demonstrated high levels of internal consistency and acceptable levels of item discrimination for the majority of the items, although lower for some items, particularly in the Risk domain. IRT analyses showed that there was a rather good match between item and respondent locations and the measurement precision was high. Disordered step and average measures for some of the items in the Risk domain indicate that these items were problematic from a psychometric point of view and only applicable for a minority of the participants. Differential item functioning for gender in some of the items suggests that they might need to be revised to minimise potential gender bias.     

Albuminuria-lowering effect of dapagliflozin,exenatide, and their combination in patients with type 2 diabetes: A randomized cross-over clinical study

Aim

To evaluate the albuminuria-lowering effect of dapagliflozin, exenatide, and the combination of dapagliflozin and exenatide in patients with type 2 diabetes and microalbuminuria or macroalbuminuria.

Methods

Participants with type 2 diabetes, an estimated glomerular filtration rate (eGFR) of more than 30 ml/min/1.73m² and an urinary albumin: creatinine ratio (UACR) of more than 3.5 mg/mmol and 100 mg/mmol or less completed three 6-week treatment periods, during which dapagliflozin 10 mg/d, exenatide 2 mg/wk and both drugs combined were given in random order. The primary outcome was the percentage change in UACR. Secondary outcomes included blood pressure, HbA1c, body weight, extracellular volume, fractional lithium excretion and renal haemodynamic variables as determined by magnetic resonance imaging.

Results

We enrolled 20 patients, who completed 53 treatment periods in total. Mean percentage change in UACR from baseline was –21.9% (95% CI: –34.8% to –6.4%) during dapagliflozin versus –7.7% (95% CI: –23.5% to 11.2%) during exenatide and –26.0% (95% CI: –38.4% to –11.0%) during dapagliflozin-exenatide treatment. No correlation was observed in albuminuria responses between the different treatments. Numerically greater reductions in systolic blood pressure, body weight and eGFR were observed during dapagliflozin-exenatide treatment compared with dapagliflozin or exenatide alone. Renal blood flow and effective renal plasma flow (ERPF) did not significantly change with either treatment regimen. However, all but four and two patients in the dapagliflozin and dapagliflozin-exenatide groups, respectively, showed reductions in ERPF. The filtration fraction did not change during treatment with dapagliflozin or exenatide, and decreased during dapagliflozin-exenatide treatment (–1.6% [95% CI: –3.2% to –0.01%]; P = .048).

Conclusions

In participants with type 2 diabetes and albuminuria, treatment with dapagliflozin, exenatide and dapagliflozin-exenatide reduced albuminuria, with a numerically larger reduction in the combined dapagliflozin-exenatide treatment group.