Addition of AZD1656 (individually titrated) to metformin gave significant improvements in glycaemic control up to 4 months, although efficacy diminished over time.
BackgroundDepression is one of the leading causes of disability and affects 10-15% of the population. The majority of people with depressive symptoms seek care and are treated in primary care. Evidence internationally for high quality care supports collaborative care with a care manager. Our aim was to study clinical effectiveness of a care manager intervention in management of primary care patients with depression in Sweden.MethodsIn a pragmatic cluster randomized controlled trial 23 primary care centers (PCCs), urban and rural, included patients aged ≥ 18 years with a new (< 1 month) depression diagnosis. Intervention consisted of Care management including continuous contact between care manager and patient, a structured management plan, and behavioral activation, altogether around 6-7 contacts over 12 weeks. Control condition was care as usual (CAU). Outcome measures: Depression symptoms (measured by Mongomery-Asberg depression score-self (MADRS-S) and BDI-II), quality of life (QoL) (EQ-5D), return to work and sick leave, service satisfaction, and antidepressant medication. Data were analyzed with the intention-to-treat principle.ResultsOne hundred ninety two patients with depression at PCCs with care managers were allocated to the intervention group, and 184 patients at control PCCs were allocated to the control group. Mean depression score measured by MADRS-S was 2.17 lower in the intervention vs. the control group (95% CI [0.56; 3.79], p = 0.009) at 3 months and 2.27 lower (95% CI [0.59; 3.95], p = 0.008) at 6 months; corresponding BDI-II scores were 1.96 lower (95% CI [− 0.19; 4.11], p = 0.07) in the intervention vs. control group at 6 months. Remission was significantly higher in the intervention group at 6 months (61% vs. 47%, p = 0.006). QoL showed a steeper increase in the intervention group at 3 months (p = 0.01). During the first 3 months, return to work was significantly higher in the intervention vs. the control group. Patients in the intervention group were more consistently on antidepressant medication than patients in the control group.ConclusionsCare managers for depression treatment have positive effects on depression course, return to work, remission frequency, antidepressant frequency, and quality of life compared to usual care and is valued by the patients.Trial registrationIdentifier: NCT02378272. February 2, 2015. Retrospectively registered.
The heel-rise test is highly reliable. The regression models herein can be employed by clinicians to evaluate the outcomes of heel-rise tests of individuals against a comparable normative population.
Background
The effect of preoperative physical activity on recovery and complications after primary breast cancer surgery is unknown. The objective of this trial was to evaluate whether a recommendation of non-supervised physical activity improved recovery after breast cancer surgery.
Methods
This parallel, unblinded, multicentre interventional trial randomized women in whom breast cancer surgery was planned. The intervention consisted of an individual recommendation of added aerobic physical activity (30 min/day), before and 4 weeks after surgery. The control group did not receive any advice regarding physical activity. The primary outcome was patient-reported physical recovery at 4 weeks after surgery. Secondary outcomes included mental recovery, complications, reoperations, and readmissions.
Results
Between November 2016 and December 2018, 400 patients were randomized, 200 to each group. Some 370 participants (180 intervention, 190 control) remained at 4 weeks, and 368 at 90 days. There was no significant difference in favour of the intervention for the primary outcome physical recovery (risk ratio (RR) 1.03, 95 per cent c.i. 0.95 to 1.13). There was also no difference for mental recovery (RR 1.05, 0.93 to 1.17) nor in mean Comprehensive Complication Index score (4.2 (range 0–57.5) versus 4.7 (0–58.3)) between the intervention and control groups.
Conclusion
An intervention with recommended non-supervised physical activity before and after breast cancer surgery did not improve recovery at 4 weeks after surgery. Registration number: NCT02560662 (http://www.clinicaltrials.gov).
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