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Hintergrund und Stand (inter-)nationaler Forschung: Medizinische Forschung erhebt neben den medizinischen Daten (MDAT) meist auch personenidentifizierende Daten, wie Einwilligungen (Informed Consent, IC). Letztere sind nach ethischen und rechtlichen Vorgaben, wie der EU-Datenschutzgrundverordnung [ref:1], [zum vollständigen Text gelangen Sie über die oben angegebene URL]

Hintergrund und Stand (inter)nationaler Forschung: Die Qualitätssicherung der Informed Consents (=ICs) von multizentrischen Studien ist für den Datenschutz [ref:1] der Teilnehmer von zentraler Bedeutung. Eine Treuhandstelle trägt dazu bei, dass die medizinischen Daten, [zum vollständigen Text gelangen Sie über die oben angegebene URL]

Aim\ud We conducted a systematic review aggregate and network meta‐analysis of psychological interventions for people with type 1 diabetes to assess their effectiveness in improving glycaemic levels.\ud \ud Methods\ud We searched the following databases from 1 January 2003 to 1 July 2018: MEDLINE, CINAHL, PsycINFO, Embase, Cochrane Controlled Trials, Web of Science, clinicaltrials.gov, Dissertation Abstract International. We included randomized controlled trials (RCT) of psychological interventions for children and adults with type 1 diabetes reported in any language. We extracted data on publications, participant characteristics at baseline, intervention and control group, and data for the primary outcome, change in glycaemic control [HbA1c (mmol/mol/%)]. Study authors were contacted for missing data. The review was registered with international prospective register of systematic reviews registration (PROSPERO) CRD42016033619.\ud \ud Results\ud Twenty‐four adult RCTs and 23 of children with type 1 diabetes were included in the systematic review. In aggregate meta‐analysis there was no overall effect of psychological intervention compared with control on HbA1c [adults, nine RCTs, n = 1102, pooled mean difference −0.12, 95% confidence intervals (CI) −0.27 to 0.03, I2 = 29.0%, P = 0.19; children, 20 RCTs, n = 2567, −0.09, 95% CI −0.22 to 0.04, I2=54.0% P=0.002]. Network meta‐analysis suggested that probability and rank‐ordering of effectiveness is highest for attention control groups (b = −0.47, 95% CI −0.80 to −0.12) followed by cognitive behavioural therapy (CBT) (−0.26, 95% CI −0.45 to −0.06) compared with usual care for adults.\ud \ud Conclusions\ud Overall psychological interventions for children and adults with type 1 diabetes do not improve glycaemic control. For adults, CBT‐based interventions have the potential to be effective.

People with psychosis have a reduced life expectancy of 10–20 years, largely due to cardiovascular disease. This trial aimed to determine the effectiveness of a modular health promotion intervention (IMPaCT Therapy) in improving health and reducing cardiovascular risk in psychosis. A multicentre, two arm, parallel cluster RCT was conducted across five UK mental health NHS trusts. Community care coordinators (CC) were randomly assigned to training and supervision in delivering IMPaCT Therapy or treatment as usual (TAU) to current patients with psychosis (cluster). The primary outcome was the physical and mental health subscales of the Short form-36 (SF-36) questionnaire. Of 104 care coordinators recruited, 52 (with 213 patients) were randomised to deliver IMPaCT therapy and 52 (with 193 patients) randomised to TAU. Of 406 patients, 318 (78%) and 301 (74%) attended 12- and 15-month follow-up respectively. IMPaCT therapy showed no significant effect on the physical or mental health component SF-36 scores versus TAU at 12 or 15 months. No effect was observed for cardiovascular risk indicators, except for HDL cholesterol, which improved more with IMPACT therapy than TAU (Treatment effect (95% CI); 0.085 (0.007 to 0.16); p = 0.034). The 22% of patients who received >180 min of IMPACT Therapy in addition to usual care achieved a greater reduction in waist circumference than did controls, which was clinically significant. Training and supervising community care coordinators to use IMPaCT therapy in patients with psychosis is insufficient to significantly improve physical or mental health quality of life. The search for effective, pragmatic interventions deliverable in health care services continues. The trial was retrospectively registered with ISRCTN registry on 23/4/2010 at ISRCTN58667926 ; recruitment started on 01/03/2010 with first randomization on 09.08.2010 ISRCTN58667926 .