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Current guidelines on secondary prevention of cardiovascular disease recommend nurse-coordinated care (NCC) as an effective intervention. However, NCC programmes differ widely and the efficacy of NCC components has not been studied. To investigate the efficacy of NCC and its components in secondary prevention of coronary heart disease by means of a systematic review and meta-analysis of randomised controlled trials. 18 randomised trials (11 195 patients in total) using 15 components of NCC met the predefined inclusion criteria. These components were placed into three main intervention strategies: (1) risk factor management (13 studies); (2) multidisciplinary consultation (11 studies) and (3) shared decision making (10 studies). Six trials combined NCC components from all three strategies. In total, 30 outcomes were observed. We summarised observed outcomes in four outcome categories: (1) risk factor levels (16 studies); (2) clinical events (7 studies); (3) patient-perceived health (7 studies) and (4) guideline adherence (3 studies). Compared with usual care, NCC lowered systolic blood pressure (weighted mean difference (WMD) 2.96 mm Hg; 95% CI 1.53 to 4.40 mm Hg) and low-density lipoprotein cholesterol (WMD 0.23 mmol/L; 95% CI 0.10 to 0.36 mmol/L). NCC also improved smoking cessation rates by 25% (risk ratio 1.25; 95% CI 1.08 to 1.43). NCC demonstrated to have an effect on a small number of outcomes. NCC that incorporated blood pressure monitoring, cholesterol control and smoking cessation has an impact on the improvement of secondary prevention. Additionally, NCC is a heterogeneous concept. A shared definition of NCC may facilitate better comparisons of NCC content and outcomes. [ABSTRACT FROM AUTHOR]

Aims/hypothesis: Glucagon-like peptide 1 (GLP-1) receptor (GLP-1R) agonism, used in the treatment of type 2 diabetes, has recently been shown to increase thermogenesis via the brain. As brown adipose tissue (BAT) produces heat by burning triacylglycerol (TG) and takes up glucose for de novo lipogenesis, the aim of this study was to evaluate the potential of chronic central GLP-1R activation by exendin-4 to facilitate clearance of lipids and glucose from the circulation by activating BAT. Methods: Lean and diet-induced obese (DIO) C57Bl/6J mice were used to explore the effect of a 5 day intracerebroventricular infusion of the GLP-1 analogue exendin-4 or vehicle on lipid and glucose uptake by BAT in both insulin-sensitive and insulin-resistant conditions. Results: Central administration of exendin-4 in lean mice increased sympathetic outflow towards BAT and white adipose tissue (WAT), resulting in increased thermogenesis as evidenced by increased uncoupling protein 1 (UCP-1) protein levels and decreased lipid content, while the uptake of TG-derived fatty acids was increased in both BAT and WAT. Interestingly, in DIO mice, the effects on WAT were blunted, while exendin-4 still increased sympathetic outflow towards BAT and increased the uptake of plasma TG-derived fatty acids and glucose by BAT. These effects were accompanied by increased fat oxidation, lower plasma TG and glucose concentrations, and reduced body weight. Conclusions/interpretation: Collectively, our results suggest that BAT activation may be a major contributor to the glucose- and TG-lowering effects of GLP-1R agonism. [ABSTRACT FROM AUTHOR]

Seminal plasma (SP) contains immunomodulatory factors that may contribute to the formation of a tolerogenic environment at the embryo implantation site. The main focus of this study was to investigate the influence of SP on female T cells in the presence and absence of antigen-presenting cells (APCs) in an in vitro model. Female PBMCs and T cells were incubated with SP from seminal fluid samples of known and variable sperm quality. The immediate effect of SP on the mRNA expression of CD25, IL-10, IFN-γ, and Foxp3 was measured. Furthermore, proliferative responses, cytokine production, and CD25 expression were determined. Exposure to SP leads to increased mRNA expression of CD25, IL-10, and Foxp3 in T cells. Induction of mRNA for IL-10 and CD25 was dependent on the presence of APCs. Both PBMCs and T cells exposed to SP showed a proliferative response and produced several cytokines. The proliferative effects of SP on T cells observed were independent of sperm quality parameters, cytokines or soluble HLA molecules in SP. Furthermore, the presence of SP induced a higher expression of CD25 on the membrane of CD4+ T cells. SP has a direct immunomodulatory effect on T cells, as reflected in a proliferative response and upregulation of Foxp3. The presence of APCs is needed to induce IL-10 and CD25 upregulation in T cells exposed to SP. In conclusion, SP has both a direct and an indirect effect mediated through APCs on T cells. [ABSTRACT FROM AUTHOR]

Patients with coronary artery disease (CAD) are at high risk of recurrent events. A healthy lifestyle can significantly reduce this risk. A previous trial, Randomized Evaluation of Secondary Prevention by Outpatient Nurse SpEcialists (RESPONSE), demonstrated that nurse-coordinated outpatient clinics improve drug treatment of cardiovascular risk factors. However, lifestyle-related risk factors, including smoking, overweight, and physical inactivity, were common and remained largely unchanged at follow-up in most patients (66%). The aim of the current study is to evaluate the impact of 3 community-based lifestyle programs in patients after hospitalization for CAD. We are conducting a multicenter (n = 15), randomized trial that will recruit 800 patients to test the efficacy of up to 3 widely available commercial lifestyle programs, aimed at patients and their partners, on top of usual care. These programs are aimed at smoking cessation (Luchtsignaal ® ), weight loss (Weight Watchers ® ), and improving physical activity (Philips DirectLife ® ). Outcomes The primary outcome at 12 months is the proportion of patients in whom at least 1 lifestyle risk factor is improved without deterioration in any of the other 2, and a relative increase of at least 30% in this proportion is considered clinically relevant. [ABSTRACT FROM AUTHOR]

• Steroid measurements in mechanically separated plasma and serum are comparable. • Levels in CellSave are slightly lower than in serum, but within the acceptable range. • Plasma from CellSave tubes can be used for multi-steroid profiling of CRPC patients. Steroid hormones are essential signalling molecules in prostate cancer (PC). However, many studies focusing on liquid biomarkers fail to take the hormonal status of these patients into account. Steroid measurements are sensitive to bias caused by matrix effects, thus assessing potential matrix effects is an important step in combining circulating tumour DNA (ctDNA) analysis with hormone status. We investigated the accuracy of multi-steroid hormone profiling in mechanically-separated plasma (MSP) samples and in plasma from CellSave Preservative (CS) tubes, that are typically used to obtain ctDNA, compared to measurements in serum. We performed multiplex steroid profiling by liquid chromatography–tandem mass spectrometry (LC–MS/MS) in samples obtained from ten healthy controls and ten castration-resistant prostate cancer (CRPC) patients. Steroid measurements were comparable between MSP and serum. A small but consistent decrease of 8–21% compared to serum was observed when using CS plasma, which was considered to be within the acceptable margin. The minimal residual testosterone levels of CRPC patients could be sensitively quantified in both MSP and CS samples. We validated the use of MSP and CS samples for multi-steroid profiling by LC–MS/MS. The optimised use of these samples in clinical trials will allow us to gain further insight into the steroid metabolism in PC patients. [ABSTRACT FROM AUTHOR]

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A letter to the editor is presented about the effect of clozapine on the cognition of patients with schizophrenia.

Background: Treatment-resistant depression (TRD) is considered one of the major clinical challenges in the field of psychiatry. An estimated 44% of patients with major depressive disorder (MDD) do not respond to two consecutive antidepressant therapies, and 33% do not respond to up to four antidepressants. Over 15% of all patients with MDD remain refractory to any treatment intervention. rTMS is considered a treatment option for patients with TRD. Likewise, iCBT is evidence-based, symptom-focused psychotherapy recommended for the treatment of TRD. Objective: This study aimed to evaluate the initial comparative clinical effectiveness of rTMS treatment with and without iCBT as an innovative intervention for the treatment of participants diagnosed with TRD. Methods: This study is a prospective two-arm randomized controlled trial. Overall, 78 participants diagnosed with TRD were randomized to one of two treatment interventions: rTMS sessions alone and rTMS sessions plus iCBT. Participants in each group were made to complete evaluation measures at baseline, and 6 weeks (discharge) from treatment. The primary outcome measure was baseline to six weeks change in mean score for the 17-item Hamilton depression rating scale (HAMD-17). Secondary outcomes included mean baseline to six-week changes in the Columbia suicide severity rating scale (CSSRS) for the rate of suicidal ideations, the QIDS-SR16 for subjective depression, and the EQ-5D-5L to assess the quality of health in participants. Results: A majority of the participants were females 50 (64.1%), aged ≥ 40 39 (50.0%), and had college/university education 54 (73.0%). After adjusting for the baseline scores, the study failed to find a significant difference in the changes in mean scores for participants from baseline to six weeks between the two interventions under study on the HAMD-17 scale: F (1, 53) = 0.15, p = 0.70, partial eta squared = 0.003, CSSRS; F (1, 56) = 0.04 p = 0.85, partial eta squared = 0.001, QIDS-SR16 scale; F (1, 53) = 0.04 p = 0.61, partial eta squared = 0.005, and EQ-5D-VAS; F (1, 51) = 0.46 p = 0.50, and partial eta squared = 0.009. However, there was a significant reduction in means scores at week six compared to baseline scores for the combined study population on the HAMD-17 scale (42%), CSSRS (41%), QIDS-SR16 scale (35%), and EQ-VAS scale (62%). Conclusion: This study did not find that combined treatment of TRD with rTMS + iCBT (unguided) was superior to treatment with rTMS alone. Our findings do not support the use of combined treatment of rTMS + iCBT for the management of TRD disorders. [ABSTRACT FROM AUTHOR]

Background: Long-acting injectable (LAI) antipsychotics, along with community treatment orders (CTOs), are used to improve treatment effectiveness through adherence among individuals with schizophrenia. Understanding real-world medication adherence, and healthcare resource utilization (HRU) and costs in individuals with schizophrenia overall and by CTO status before and after second generation antipsychotic (SGA)-LAI initiation may guide strategies to optimize treatment among those with schizophrenia. Methods: This retrospective observational single-arm study utilized administrative health data from Alberta, Canada. Adults (≥ 18 years) with schizophrenia who initiated a SGA-LAI (no use in the previous 2-years) between April 1, 2014 and March 31, 2016, and had ≥ 1 additional dispensation of a SGA-LAI were included; index date was the date of SGA-LAI initiation. Medication possession ratio (MPR) was determined, and paired t-tests were used to examine mean differences in all-cause and mental health-related HRU and costs (Canadian dollars), comprised of hospitalizations, physician visits, emergency department visits, and total visits, over the 2-year post-index and 2-year pre-index periods. Analyses were stratified by presence or absence of an active CTO during the pre-index and/or post-index periods. Results: Among 1,211 adults with schizophrenia who initiated SGA-LAIs, 64% were males with a mean age of 38 (standard deviation [SD] 14) years. The mean overall antipsychotic MPR was 0.39 (95% confidence interval [CI] 0.36, 0.41) greater during the 2-year post-index period (0.84 [SD 0.26]) compared with the 2-year pre-index period (0.45 [SD 0.40]). All-cause and mental health-related HRU and costs were lower post-index versus pre-index (p < 0.001) for hospitalizations, physician visits, emergency department visits, and total visits; mean total all-cause HRU costs were $33,788 (95% CI -$38,993, -$28,583) lower post- versus pre-index ($40,343 [SD $68,887] versus $74,131 [SD $75,941]), and total mental health-related HRU costs were $34,198 (95%CI -$39,098, -$29,297) lower post- versus pre-index ($34,205 [SD $63,428] versus $68,403 [SD $72,088]) per-patient. Forty-three percent had ≥ 1 active CTO during the study period; HRU and costs varied according to CTO status. Conclusions: SGA-LAIs are associated with greater medication adherence, and lower HRU and costs however the latter vary according to CTO status. [ABSTRACT FROM AUTHOR]

Marital status is associated with prognosis in patients with cardiovascular disease (CVD). However, the influence of partners on successful modification of lifestyle-related risk factors (LRFs) in secondary CVD prevention is unclear. Therefore, we studied the association between the presence of a partner, partner participation in lifestyle interventions and LRF modification in patients with coronary artery disease (CAD). In a secondary analysis of the RESPONSE-2 trial (n = 711), which compared nurse-coordinated referral to community-based lifestyle programs (smoking cessation, weight reduction and/or physical activity) to usual care in patients with CAD, we investigated the association between the presence of a partner and the level of partner participation on improvement in >1 LRF (urinary cotinine <200 ng/l, ≥5% weight reduction, ≥10% increased 6-min walking distance) without deterioration in other LRFs at 12 months follow-up. The proportion of patients with a partner was 80% (571/711); 19% women (108/571). In the intervention group, 48% (141/293) had a participating partner in ≥1 lifestyle program. Overall, the presence of a partner was associated with patients' successful LRF modification (adjusted risk ratio (aRR) 1.93, 95% confidence interval (CI) 1.40–2.51). A participating partner was associated with successful weight reduction (aRR 1.73, 95% CI 1.15–2.35). The presence of a partner is associated with LRF improvement in patients with CAD. Moreover, patients with partners participating in lifestyle programs are more successful in reducing weight. Involving partners of CAD patients in weight reduction interventions should be considered in routine practice. • Having a partner is associated with successful lifestyle-related risk factor modification in patients with coronary artery disease. • Patients with a participating partner in lifestyle programs were significantly more successful in reducing weight. • No sex differences were found in (participating) partner effect on patients' lifestyle-related risk factor modification. [ABSTRACT FROM AUTHOR]

International guidelines for the management of valvular heart disease recommend frailty assessment prior to Transcatheter Aortic Valve Implantation (TAVI), however there is no consensus how to assess frailty. We investigated whether frailty status assessed with the Edmonton Frail Scale (EFS, range 0–17 points) relates to length of stay (LOS), short- and long-term mortality and adverse outcomes after TAVI. In this study we included 357 patients between April 2016 till December 2018. EFS was assessed at baseline. Patients were classified into low (0–3), intermediate (4–7) or high frailty status (8‐17). LOS was defined as the number of days between admission and discharge. Mortality data were obtained up to four years after TAVI. Adverse events were defined by Valve Academic Research Consortium (VARC)-2 criteria and collected <30 days after TAVI. Patients with higher frailty status had longer median LOS (days (IQR): low 5 (3), intermediate 6 (4) and high 7 (5), p < 0.001) and higher mortality: low vs intermediate vs high at 30 days 0.5%, 2.2%, 7.0% (p = 0.050), 1 year 3.7%, 10.0%, 15.2% (p = 0.052), 2 years 9.2%, 17.8%, 31.7% (p = 0.003), 3 years 17.2%, 24.0, 47.0% (p = 0.001) and 4 years 19.6%, 30.8%, 55.6% (p < 0.001). Frail patients received more often a pacemaker (2.6%, 6.6%, 13.5%, p = 0.048). In clinical practice, the EFS is a useful tool to screen for frailty in TAVI patients. This tool may possibly be expanded to determine benefit versus harm-risk in these patients and whether specific pre-procedurally interventions are needed in order to reduce mortality. • Edmonton Frail Scale is a useful tool to screen for frailty in TAVI patients. • High frailty is related to length of stay and mortality after TAVI. • Longer length of stay and short term mortality are not due to stroke or vascular complications. [ABSTRACT FROM AUTHOR]