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Postpartum depression (PPD) poses significant challenges, affecting both mothers and children, with substantial societal and economic implications. Internet-based cognitive behavioral therapy interventions (iCBT) offer promise in addressing PPD, but their economic impact remains unexplored. This study aimed to evaluate the cost-utility of Be a Mom, a self-guided iCBT intervention, compared with a waiting-list control among postpartum women at high risk of PPD. This economic evaluation was conducted alongside a 14-month randomized controlled trial adopting a societal perspective. Participants were randomized to Be a Mom (n = 542) or a waitlisted control group (n = 511). Self-report data on healthcare utilization, productivity losses, and quality-adjusted life years (QALYs) were collected at baseline, post-intervention, and 4 and 12 months post-intervention. Incremental cost-effectiveness ratios (ICERs) were calculated, and cost-effectiveness acceptability curves were generated using nonparametric bootstrapping. Sensitivity analyses were conducted to assess result robustness. Over 14 months, Be a Mom generated a QALY gain of 0.0184 (0.0022, 0.0346), and cost savings of EUR 34.06 (−176.16, 108.04) compared to the control group. At a willingness to pay of EUR 20,000, Be a Mom had a 97.6 % probability of cost-effectiveness. Results have limitations due to self-selected sample, potential recall bias in self-reporting, missing data, limited follow-up, and the use of a waiting-list control group. This study addresses a critical gap by providing evidence on the cost-utility of an iCBT intervention tailored for PPD prevention. Further research is essential to identify scalable and cost-effective interventions for reducing the burden of PPD. • First randomized trial on cost-utility of iCBT for prevention of PPD • Compared to the control group, the intervention yielded more QALYs and less costs over 14 months. • The intervention had a 97.6 % probability of cost-effectiveness at a WTP of EUR 20,000. • iCBT has the potential to be adopted as a cost-effective preventive strategy for PPD. [ABSTRACT FROM AUTHOR]

In an inpatient treatment center for pediatric obesity, the effectiveness of an emotion regulation (ER) training on top of the multidisciplinary obesity treatment (MOT) was tested by means of an RCT. The ER training was evaluated on primary outcomes: ER and emotional eating, and secondary outcomes: well-being and weight loss, taking into account pre, post, and follow-up measurements. Of the 115 10- to-14-year old adolescents with obesity (52.2% girls), 65 were allocated to the ER training. Physicians measured their height and weight objectively (4 times). Participants also filled out questionnaires on ER competencies (ER abilities and ER strategies), emotional eating and well-being (3 times). Significant pre-post interactions were found for "emotional awareness," "problem solving," and "evoking a positive mood." Moreover, the positive effects of the ER training on emotion regulation strategies were maintained at follow-up. Concerning well-being, no significant pre-post interaction effects were found but a significant interaction effect was found when comparing pre with follow-up. Analyses show a significant main effect of time on weight loss, but this was not qualified by a Time × Condition interaction effect. The current RCT study shows limited but promising effects of adding an ER training to the MOT. Further research should investigate whether the positive short-term effects will be maintained. [ABSTRACT FROM AUTHOR]

Pregnant women often experience anxiety due to pregnancy, negatively impacting their and their fetus' health. Non-pharmacological interventions, such as virtual reality (VR), could reduce anxiety levels, potentially impacting non-stress tests or the physiological responses of the pregnant woman and the fetus. A randomized clinical trial conducted between February and December 2022 involved 286 term pregnant women. They were divided into a VR intervention group (146 women) and a control group (140 women). The intervention consisted of 20 min of 3D glasses with images and sounds during a third-trimester nonstress test. Anxiety was measured using the Spielberg State-Trait Anxiety Inventory (STAI), alongside physiological parameters. The VR group exhibited lower anxiety levels compared to controls (STAI score: Rosenthal's r: −0.54, p = 0.01; state anxiety: Rosenthal's r: −0.40, p = 0.001; trait anxiety: Rosenthal's r: −0.41, p = 0.001). Within the VR group, there was a significant reduction in trait anxiety (Rosenthal's r, 1.27; p < 0.001) and total anxiety (Rosenthal's r, 1.63; p < 0.001) post-intervention, along with decreased systolic blood pressure (p < 0.001), diastolic blood pressure (p < 0.001), and maternal heart rate (p = 0.02). Future research could explore additional pregnancy-related variables, such as postpartum anxiety. The results confirm that the use of VR is beneficial for pregnant women and their fetuses, as it decreases anxiety levels, and improves physiological parameters such as blood pressure and maternal heart rate during the nonstress test. VR is a technique that is easy to integrate into the healthcare system due to its non-invasive and non-pharmacological nature. • Virtual reality has proven to be an effective technique in reducing anxiety of pregnant women during NST. • Anxiety is related to higher blood pressure and heart rate values in pregnant women during NST. • Blood pressure and heart rate in pregnant women improved when virtual reality was used as a therapy. [ABSTRACT FROM AUTHOR]

Depressed patients who have become victim of violence are prone to revictimization. However, no evidence-based interventions aimed at reducing revictimization in this group exist. This multicenter randomized controlled trial evaluated the effectiveness of an internet-based emotion regulation training (iERT) added to TAU in reducing revictimization, emotion dysregulation, and depressive symptoms in recently victimized, depressed patients compared to TAU alone. Adult outpatients (N = 153) with a depressive disorder who had experienced threat, physical assault, or sexual assault within the previous three years were randomly allocated to TAU+iERT (n = 74) or TAU (n = 79). TAU involved psychotherapy (mainly cognitive behavioral therapy [77.8 %]). iERT comprised six guided online sessions focused on the acquisition of adaptive emotion regulation skills. The primary outcome measure was the number of revictimization incidents at 12 months after baseline, measured with the Safety Monitor. Analyses were performed according to the intention-to-treat principle. Both groups showed a large decrease in victimization incidents. Mixed-model negative binomial regression analyses showed that TAU+iERT was not effective in reducing revictimization compared to TAU (IRR = 0.97; 95%CI = 0.64,1.46; p =.886). Linear mixed-model analyses demonstrated that TAU+iERT yielded a larger reduction of emotion dysregulation (B = −7.217; p =.046; Cohens d = 0.33), but not depressive symptoms (B = −1.041; p =.607) than TAU. The study was underpowered to detect small treatment effects. Additionally, uptake of iERT was quite low. Although TAU+iERT resulted in a larger decrease of emotion dysregulation than TAU alone, it was not effective in reducing revictimization and depressive symptoms. Patients' revictimization risk substantially decreased during psychotherapy. • Online emotion regulation training improved emotion regulation in depressed patients. • iERT did not reduce revictimization rates or depressive symptoms compared to TAU. • Violent victimization rates decreased substantially during psychotherapy. [ABSTRACT FROM AUTHOR]

The pathophysiology and the potential risks of placental transfusion (PT) differ substantially in preterm infants, necessitating specific studies in this population. This study aimed to evaluate the safety and efficacy of PT in preterm infants from the perspective of long-term neurodevelopmental outcomes. We conducted a systematic literature search using placental transfusion, preterm infant, and its synonyms as search terms. Cochrane Central Register of Controlled Trials, Medline, and Embase were searched until March 07, 2023. Two reviewers independently identified, extracted relevant randomized controlled trials, and appraised the risk of bias. The extracted studies were included in the meta-analysis of long-term neurodevelopmental clinical outcomes using fixed-effects models. A total of 5612 articles were identified, and seven randomized controlled trials involving 2551 infants were included in our meta-analysis. Compared with immediate cord clamping (ICC), PT may not impact adverse neurodevelopment events. No clear evidence was found of a difference in the risk of neurodevelopmental impairment (risk ratio [RR]: 0.89, 95% confidence interval [CI]: 0.76 to 1.03, P = 0.13, I2 = 0). PT was not associated with the incidence of cerebral palsy (RR: 1.23, 95% CI: 0.59 to 2.57, P = 0.79, I2 = 0). Analyses showed no differences between the two interventions in cognitive, language, and motor domains of neurodevelopment. From the perspective of long-term neurodevelopment, PT at preterm birth may be as safe as ICC. Future studies should focus on standardized, high-quality clinical trials and individual participant data to optimize cord management strategies for preterm infants after birth. [ABSTRACT FROM AUTHOR]

Subjective support could ameliorate the adverse effect of (pre)frailty on depressive symptoms. However, there is scarce evidence regarding subjective support-focused intervention in preventing depression among (pre)frail community-dwelling older adults. This study aims to explore the effectiveness of subjective support-focused cognitive behavioral therapy (SS-CBT) in preventing depression among this group of population. A total of 100 community-dwelling (pre)frail older adults were recruited from six communities in a Chinese city and were randomized to an 8-week SS-CBT group or a wait-list control group. Depressive symptoms and subjective support were assessed at baseline (T0), and at 8 week (T1), 12 week (T2), 16 week (T3) after randomization. Generalized estimating equation was used to examine the effectiveness of SS-CBT on depressive symptoms and subjective support. Hierarchical linear regression models and Bootstrapping method were used to examine whether subjective support mediated the effectiveness of SS-CBT on depressive symptoms. Participants in SS-CBT group reported significant reduction in depressive symptoms (Wald χ 2 = 20.800, p < 0.001) and improvement in subjective support (Wald χ 2 = 92.855, p < 0.001) compared to those in wait-list control group. Changes in subjective support mediated the effectiveness of SS-CBT on changes in depressive symptoms. Restricted regions to recruit participants, inclusion of the most motivated participants, lack of diagnosis of depression, potential experimenter bias and contamination, short follow-up period, and lack of an active control group. The findings support the benefits of SS-CBT in preventing depression among (pre)frail community-dwelling older adults, and provide insight into possible mechanisms. • (Pre)frail older adults are more likely to experience depression. • Subjective support is effective in protecting depression. • Cognitive behavioral therapy has the potential to improve subjective support. [ABSTRACT FROM AUTHOR]

We evaluated if Insulin-like Factor 3, basal and human chorionic gonadotropin (hCG)-stimulated testosterone could predict beneficial effects of testosterone replacement among 69 testicular cancer survivors with mild Leydig cell insufficiency randomly assigned to testosterone replacement therapy or placebo. Although the patients with Insulin-like Factor 3 and hCG-stimulated testosterone below median at baseline had less fat mass after 12 months of testosterone replacement therapy compared with placebo, we cannot recommend testosterone replacement therapy in specific subgroups of men with mild Leydig cell insufficiency. Introduction: Mild Leydig cell insufficiency affects a substantial proportion of testicular cancer survivors. Previous studies have not shown a beneficial effect of testosterone replacement therapy, however, with a pronounced interindividual effect. Thus, biomarkers identifying the subgroups that might benefit are wanted. We aimed to determine if insulinlike factor 3 (INSL3), basal and human chorionic gonadotropin (hCG)-stimulated testosterone can predict the effect of testosterone replacement therapy in testicular cancer survivors with mild Leydig cell insufficiency. Patients and Methods: We randomized adult testicular cancer survivors with mild Leydig cell insufficiency 1:1 to 12 months of transdermal testosterone replacement therapy (Tostran gel 2%) or placebo. INSL3, basal, and hCG-stimulated testosterone were measured at baseline. Outcomes (glucose, insulin, HbA1C, lipids, blood pressure, and body composition) were measured at baseline, 6 and 12 months. We applied a linear mixed-effect model comparing patients receiving testosterone with placebo in subgroups by biomarker. Results: We included and randomized 69 patients between October 2016 and February 2018. Patients with INSL3 and hCG-stimulated testosterone concentrations below the median had a -1.7 kg (95% CI: -3.1, -0.4) and -2.0 kg (95% CI: -3.5, -0.6) change in fat mass after 12 months of testosterone replacement therapy compared with placebo. This was not the case in patients with INSL3 and hCG-stimulated testosterone above the median. We did not find any effect of these biomarkers on glucose, insulin, HbA1c, or lipids. Conclusion: Patients with INSL3 and hCG-stimulated testosterone concentrations below the median had decreased fat mass after 1 12 months of testosterone replacement therapy compared with placebo. It should be evaluated in larger trials if these biomarkers can be used as predictive markers identifying testicular cancer patients with mild Leydig cell insufficiency who might benefit from testosterone substitution. [ABSTRACT FROM AUTHOR]

As the prevalence of tramadol toxicity is increasing, managing these patients with the aim of treatment and complete recovery has become a major challenge for health care professionals. This study evaluated the short-term effects of IV lipid emulsion (ILE) administration in cases of tramadol poisoning. In this double-blind, randomized controlled trial, 120 patients with pure tramadol poisoning and a Glasgow Coma (GCS) score ≤ 12 referred to a poisoning center in Tehran, Iran were selected and randomly assigned 1:1 to receive ILE 20% (intervention) or 0.9% saline (control) after admission and primary stabilization. The patient's vital signs, GCS score, hospitalization duration, and rate of seizure occurrence were recorded and compared between the two groups. Mean (SD) age of participants was 25.3 (5.4) years and 84 (70%) were male. Mean (SD) ingested dose of tramadol was 3118 (244) mg, which was not different between the groups. Compared with controls, the ILE group had a higher level of consciousness after treatment (median [interquartile range] GCS score 12 [10–13] vs. 10 [8–12]; p = 0.03). In addition, length of hospitalization (median [interquartile range] (2 [1–3] days vs. 4 [4–6] days; p < 0.01) and rate of seizure occurrence were lower in the intervention group (16/60 vs. 30/60; p < 0.01). In the setting of tramadol poisoning with a decreased level of consciousness and based on our study's findings, administration of ILE is suggested to help manage patients in hospital emergency departments. However, larger trials might be needed to confirm these findings before entering the guidelines. [ABSTRACT FROM AUTHOR]

Up to 79 % of older adults with depression do not receive treatments commensurate with guideline recommendations. Metacognitive Training-Silver (MCT-Silver) is a low-intensity group training, which aims to reduce depressive symptoms by targeting (meta)cognitive beliefs. A randomized controlled trial comparing MCT-Silver (n = 41) to cognitive remediation (n = 39) was conducted with older adults with major depressive disorder and/or dysthymia. Clinician-rated depression (Hamilton Depression Rating Scale [HDRS, primary outcome]), self-reported depression (Beck Depression Inventory-II [BDI-II]), negative cognitive beliefs, positive metacognitive beliefs, rumination, health status, quality of life, and neurocognitive functioning were assessed at baseline, eight weeks (post) and three months (follow-up). Both groups demonstrated moderate to large reductions in depression. No superior effects of MCT-Silver on clinician-rated depression (HDRS) were detected. MCT-Silver led to greater reductions in self-reported depression and rumination at post- and follow-up. Despite this, scores at post- and follow-up assessments were similar for both groups. MCT-Silver's effect on depressive symptoms was moderated by baseline rumination, positive metacognitive beliefs and previous treatment experience. MCT-Silver was evaluated as superior according to patient appraisals. Conclusions are limited by divergent findings on measures of depression and that the study was conducted during the COVID-19 pandemic. Whereas no superior effect of MCT-Silver was found for the primary outcome, there was a significant effect of MCT-Silver for self-reported depression and rumination. Patients endorsing rumination and positive metacognitive beliefs as well as those without previous psychological treatment may benefit more from MCT-Silver. • We evaluated the efficacy of metacognitive training for depression in later life (MCT-Silver). • 80 patients were randomized to MCT-Silver or a cognitive remediation (CR) group. • MCT-Silver demonstrated statistically significant effects beyond CR on self-reported depression and rumination. • Despite statistically significant effects, total scores at post- and follow-up were similar between groups. [ABSTRACT FROM AUTHOR]

• We developed meaning-centered psychotherapy for eating disorders (MCP-ED). • The efficacy of MCP-ED was tested in women with high weight and shape concerns. • After MCP-ED and at follow-up, participants reported higher levels of life meaning. • MCP-ED also resulted in lower levels of eating disorder symptoms. • Future studies should test the effectiveness of MCP-ED in a clinical sample. Low meaning in life has been proposed as an important factor in the maintenance of eating disorders and previous findings suggest that targeting meaning might optimize treatment effectiveness. The current randomized controlled trial aimed to investigate the efficacy of meaning-centered psychotherapy adjusted for eating disorders (MCP-ED) to improve meaning in women with high weight and shape concerns. Female students with high weight and shape concerns (N = 134) were randomly assigned to the waiting-list control condition or the experimental condition, in which they followed six weekly individual sessions of MCP-ED. Self-report measures of meaning, eating disorder symptoms, general distress, psychological well-being, and satisfaction with meaningful life domains were completed at baseline, after the final session of MCP-ED or a 7-week waiting period, and at 4-week follow-up. Participants in the experimental condition showed a stronger increase in meaning than participants in the waiting-list condition after the intervention and at follow-up. The intervention also resulted in lower eating disorder symptoms and general distress, and higher psychological well-being and satisfaction with meaningful life domains. Findings support the efficacy of MCP-ED as an intervention to increase meaning and point to the relevance of examining whether adding MCP-ED to regular treatment might increase treatment effectiveness in individuals with eating disorders. [ABSTRACT FROM AUTHOR]

Current management guidelines for the treatment of carotid stenosis are controversial. We performed this meta-analysis to evaluate the perioperative safety of carotid artery stenting (CAS) and endarterectomy. We systematically searched EMBASE, PubMed, Web of Science, and the Cochrane Library from inception to November 10, 2022, for randomized controlled trials that compared CAS with carotid endarterectomy (CEA) among patients with carotid stenosis. The analyzed outcomes mainly included stroke, death, myocardial infarction (MI), cranial nerve palsy, the cumulative incidence of mortality, stroke, or MI and the cumulative incidence of death or stroke in the perioperative periods. The risk ratio (RR) and 95% confidence interval (95% CI) were calculated and pooled. Subgroup analyses were based on whether patients were symptomatic or asymptomatic. We assessed the certainty of evidence using the Grading of Recommendations Assessment, Development and Evaluation framework. Seventeen randomized controlled trials with 12,277 participants (6514 and 5763 in the CAS and CEA groups, respectively) were included. Pooled analysis demonstrated that compared with CEA, CAS was associated with decreased risks of perioperative MI (RR = 0.47, 95% CI = 0.29∼0.77) and perioperative cranial nerve palsy (RR = 0.02, 95% CI = 0.01∼0.06) but higher risks of perioperative stroke (RR = 1.48, 95% CI = 1.18∼1.87) and cumulative incidence of death or stroke (RR = 1.52, 95% CI = 1.20∼1.93). The perioperative safety was equivalent between CAS and CEA. However, CEA may be preferred when considering both procedural safety and long-term efficacy in preventing recurrent stroke. [ABSTRACT FROM AUTHOR]

Early adverse parenting predicts various negative outcomes, including psychopathology and altered development. Animal work suggests that adverse parenting might change amygdala–prefrontal cortex (PFC) circuitry, but work in humans remains correlational. The present study leveraged data from a randomized controlled trial examining the efficacy of an early parenting intervention targeting parental nurturance and sensitivity (Attachment and Biobehavioral Catch-up [ABC]) to test whether early parenting quality causally affects amygdala-PFC connectivity later in life. Participants (N = 60, mean age = 10.0 years) included 41 high-risk children whose parents were referred by Child Protective Services and randomly assigned to receive either ABC (n = 21) or a control intervention (n = 20) during the children's infancy and a comparison sample of low-risk children (n = 19). Amygdala-PFC connectivity was assessed via functional magnetic resonance imaging while children viewed fearful and neutral faces. Across facial expressions, ABC produced different changes than the control intervention in amygdala-PFC connectivity in response to faces. The ABC group also exhibited greater responses than the control intervention group to faces in areas classically associated with emotion regulation, including the orbitofrontal cortex and right insula. Mediation analysis suggested that the effect of ABC on PFC activation was mediated by the intervention's effect on amygdala-PFC connectivity. Results provide preliminary causal evidence for the effect of early parenting intervention on amygdala-PFC connectivity and on PFC responses to face viewing. Findings also highlight amygdala-PFC connectivity as a potential mediator of the effects of early parenting intervention on children's emotion regulation development. Intervening Early With Neglected Children; https://clinicaltrials.gov/ ; NCT02093052. We worked to ensure sex and gender balance in the recruitment of human participants. We worked to ensure race, ethnic, and/or other types of diversity in the recruitment of human participants. We worked to ensure that the study questionnaires were prepared in an inclusive way. One or more of the authors of this paper self-identifies as a member of one or more historically underrepresented racial and/or ethnic groups in science. One or more of the authors of this paper self-identifies as a member of one or more historically underrepresented sexual and/or gender groups in science. One or more of the authors of this paper received support from a program designed to increase minority representation in science. While citing references scientifically relevant for this work, we also actively worked to promote sex and gender balance in our reference list. [ABSTRACT FROM AUTHOR]

The aim of this double-blind, and randomized controlled clinical trial was to evaluate the 5-year clinical performance of posterior resin composite restorations placed with the incremental filling technique [IF] or the bulk-fill technique [BF]. Two different adhesive systems were used: etch-&-rinse (ER) or self-etch (SE). Posterior dental teeth of 72 participants (n = 236), with a cavity depth of at least 3 mm, were randomly divided into four groups. Restorations were applied with either Tetric N-Bond or Tetric N-Bond SE. The composite resin Tetric N-Ceram Bulk-Fill was placed either with IF or BF. Restorations were evaluated using FDI criteria at baseline and after 1, 2, 3, 4, and 5 years. Statistical analysis was performed using the Wilcoxon Signed rank test (a=0.05). Two hundred and four restorations were evaluated after 5 years. Eleven restorations were considered 'failed', ten due to fracture (4 IF and 6 BF) and one due to secondary caries (IF). The annual failure rate was 1.2% for BF and 1% for IF (p = 0.35). When comparing BF and IF, no significant differences were found for any of the parameters evaluated (p > 0.05). Regarding the adhesive systems, 44 and 51 restorations showed minor problems in terms of marginal adaptation and staining, with significantly more marginal discoloration when the self-etch adhesive was used (p = 0.002). The bulk-fill restorative technique showed good clinical behavior compared to the incremental filling technique, especially when using an etch-&-rinse adhesive, after 5 years of clinical evaluation. [Display omitted] • Bulk-fill technique had similar clinical behavior to incremental filling technique. • Use of etch & rinse adhesive reduced the risk of marginal staining after 5 years. • Minor not significant discrepancies in color match were shown between techniques. [ABSTRACT FROM AUTHOR]

To assess whether the use of rapid influenza diagnostic tests (RIDTs) for long-term care facility (LTCF) residents with acute respiratory infection is associated with increased antiviral use and decreased health care utilization. Nonblinded, pragmatic, randomized controlled trial evaluating a 2-part intervention with modified case identification criteria and nursing staff–initiated collection of nasal swab specimen for on-site RIDT. Residents of 20 LTCFs in Wisconsin matched by bed capacity and geographic location and then randomized. Primary outcome measures, expressed as events per 1000 resident-weeks, included antiviral treatment courses, antiviral prophylaxis courses, total emergency department (ED) visits, ED visits for respiratory illness, total hospitalizations, hospitalizations for respiratory illness, hospital length of stay, total deaths, and deaths due to respiratory illness over 3 influenza seasons. Oseltamivir use for prophylaxis was higher at intervention LTCFs [2.6 vs 1.9 courses per 1000 person-weeks; rate ratio (RR) 1.38, 95% CI 1.24-1.54; P <.001]; rates of oseltamivir use for influenza treatment were not different. Rates of total ED visits (7.6 vs 9.8/1000 person-weeks; RR 0.78, 95% CI 0.64-0.92; P =.004), total hospitalizations (8.6 vs 11.0/1000 person-weeks; RR 0.79, 95% CI 0.67-0.93; P =.004), and hospital length of stay (35.6 days vs 55.5 days/1000 person-weeks; RR 0.64, 95% CI 0.0.59-0.69; P <.001) were lower at intervention as compared to control LTCFs. No significant differences were noted for respiratory-related ED visits or hospitalizations or in rates for all-cause or respiratory-associated mortality. The use of low threshold criteria to trigger nursing staff–initiated testing for influenza with RIDT resulted in increased prophylactic use of oseltamivir. There were significant reductions in the rates of all-cause ED visits (22% decline), hospitalizations (21% decline), and hospital length of stay (36% decline) across 3 combined influenza seasons. No significant differences were noted in respiratory-associated and all-cause deaths between intervention and control sites. [ABSTRACT FROM AUTHOR]

Randomized controlled trials (RCTs) that conduct subgroup analyses have the potential to provide information on treatment decisions in specific groups of patients from heterogeneous populations. Although we understand several factors can modify the incidence of venous thromboembolism (VTE) and the benefit/risk ratio of anticoagulation treatments, further evidence is warranted to show the heterogeneity of treatment effects in different subgroups of patients. The primary purpose was to evaluate the appropriateness and interpretation of subgroup analysis performed on VTE RCTs reporting pharmacological interventions. A systematic review of RCTs published between January 2017 and January 2022 was conducted. Claims of subgroup effects were evaluated with predefined criteria. High-quality claims of subgroup effect were further analyzed and discussed. Overall, 28 RCTs with a generally low bias risk were included. The purposes of the treatments included pharmacologic thromboprophylaxis (17), therapeutic dose anticoagulation (9), and catheter-directed pharmacologic thrombolysis (2). The evaluated subgroup analyses generally presented: a high number of subgroup analyses reported, a lack of prespecification, and a lack of usage of statistical tests for interaction. The authors reported 13 claims of subgroup effect; only two were considered potentially reliable to represent heterogeneity in the direction or magnitude of treatment effect. Subgroup analyses of VTE RCTs reporting pharmacologic interventions are generally methodologically poor. Most claims of subgroup effect did not meet critical criteria and lacked credibility. Clinicians in this field may proceed with scepticism when assessing claims of subgroup effects due to methodological concerns and misleading interpretations. [Display omitted] [ABSTRACT FROM AUTHOR]

The primary objective of this research was to assess the impact of a novel, peer-directed intervention (iNSPiRED) on diabetes distress (DD) among veterans with type 2 diabetes and DD. Secondary objectives were to assess iNSPiRED's impact on anxiety, depression, and diabetes self-management behaviors. A single-blinded, randomized, parallel-group trial was conducted. Participants (n = 218) were recruited through a Veterans Affairs medical center and community agencies in a major metropolitan area from September 2019 through January 2022. Certified mental health peer specialists delivered iNSPiRED, a three-month goal-setting and resource navigation intervention. Outcomes were assessed at baseline, postintervention, and month six. Multilevel random-intercept linear regression models with treatment x time interaction terms were used to assess treatment effects. Frequency of following a healthy eating plan was higher for iNSPiRED vs usual care at month three relative to baseline (B = 0.58; p = 0.03) after adjusting for race and socioeconomic status. No other treatment effects differed significantly from zero (ps ≥ 0.05). Peer-directed interventions have the potential to deliver low-cost, highly scalable care. However, based on the largely negative findings of the current study, it is likely that more intense, multimodal interventions are needed to address DD. • Diabetes distress (DD) is linked to poor diabetes outcomes and quality of life. • A peer-led intervention (iNSPiRED) targeting DD and related outcomes was tested. • iNSPiRED participants improved more in frequency of healthy eating vs usual care. • No other treatment effects differed significantly from zero (ps ≥ 0.05). • More intense, multimodal interventions may be needed to address DD. [ABSTRACT FROM AUTHOR]

We previously reported the finding of symptom relief in a randomized controlled trial with the combined use of kakkonto and shosaikotokakikyosekko added to conventional treatment in patients with coronavirus disease 2019 (COVID-19). For further evaluation, we performed post hoc analysis focused on symptom disappearance without recurrence, to determine a clearer effect of Kampo medicine. Patients with mild and moderate COVID-19 were randomly allocated to a control group receiving symptomatic therapy or a Kampo group receiving kakkonto (2.5 g) with shosaikotokakikyosekko (2.5 g) three times daily in addition to symptomatic therapy. The data of 161 patients (Kampo group, n = 81; control group, n = 80) were analyzed post hoc for the time to symptom disappearance. Kaplan-Meier and Cox proportional hazard estimates of disappearance of symptoms showed that all and each symptom targeted in this study disappeared faster in the Kampo group than in the control group, although not statistically significant (all symptomatic cases; hazard ratio [HR] 3.73, 95% confidence interval [CI] 0.46−29.98, log-rank p = 0.1763). In a supplemental assessment using covariate adjustment and competing risk analysis, fever disappeared faster in the Kampo group than in the control group (all symptomatic cases, HR 1.62, 95% CI 0.99−2.64, p = 0.0557; unvaccinated cases, HR 1.68, 95% CI 1.00−2.83, p = 0.0498) and shortness of breath disappeared significantly faster in Kampo group than in control group (all symptomatic cases, HR 1.92, 95% CI 1.07−3.42, p = 0.0278; unvaccinated cases, HR 2.15, 95% CI 1.17−3.96, p = 0.0141). These results demonstrate the advantages of Kampo treatment for acute COVID-19. [ABSTRACT FROM AUTHOR]

Transcutaneous auricular vagus nerve stimulation (taVNS) is used for treating depression but the efficacy and safety have not been well assessed. This study was conducted to evaluate the efficacy and safety of taVNS in depression. The retrieval databases included English databases of PubMed, Web of Science, Embase, the Cochrane Library and PsycINFO, and Chinese databases of CNKI, Wanfang, VIP and Sino Med, and the retrieval period was from their inception to November 10, 2022. The clinical trial registers (ClinicalTrials.gov and Chinese Clinical Trial Registry) were also searched. Standardized mean difference and the risk ratio were used as the effect indicator and the effect size was represented by the 95 % confidence interval. Revised Cochrane risk-of-bias tool for randomized trials and the Grades of Recommendation, Assessment, Development and Evaluation system were used to assess the risk of bias and quality of evidence respectively. Totally, 12 studies of 838 participants were included. taVNS could significantly improve depression and reduce Hamilton Depression Scale scores. Low to very low evidence showed that taVNS had higher response rates than sham-taVMS and comparable response rates compared to antidepressants (ATD) and that taVNS combined with ATD had comparable efficacy to ATD with fewer side effects. The number of studies in subgroups was small and the evidence quality was low to very low. taVNS is an effective and safe method for alleviating depression scores and had a comparable response rate to ATD. • taVNS is an effective and safe method for mild to moderate depression. • taVNS has significantly higher response rate than sham-taVNS. • taVNS has comparable effect than antidepressants in reducing Hamilton Depression Scale scores with less side effects. [ABSTRACT FROM AUTHOR]

Bedtime Procrastination (BP) is defined as the behavior of going to bed later than intended, without external reasons. This study is a randomized controlled trial aiming to establish efficacy of a behavioral intervention to decrease BP in a non-clinical sample. This was an open-label trial that was conducted in sixty participants (mean age 21.33 ± 2.35 years, 86.7% females) without insomnia or psychopathology who endorsed frequent BP. They were randomized to either the treatment group (n = 32) or wait-list control group (n = 28). Participants completed the Bedtime Procrastination Scale (BPS), the Epworth Sleepiness Scale (ESS), the Insomnia Severity Index (ISI), Center for Epidemiologic Studies Depression Scale (CES-D), Morningness-Eveningness Questionnaire (MEQ), and a weekly sleep diary. Functional analysis was conducted to investigate the function of BP. Linear mixed models were used for analyses. The treatment group showed significant improvement on the BPS (35.56% decrease, d = 2.19, bedtime procrastination duration based on the sleep diary (−46.29 min, d = 1.22), and sleep efficiency (5.70% increase, d = 1.25) compared to the wait-list control group following the intervention. There were also significant reductions in time spent from bedtime to lights out, and wake time to time out of bed, in addition to improvements in ISI and ESS scores in the treatment group compared to the control group. Functional analysis results indicated emotional regulation (31.3%), compensation (26.5%), and social interaction and belongingness (18.1%) as the most frequent functions of bedtime procrastination. This study shows promising results for a behavioral intervention targeting BP and sleep. In addition, this study demonstrated various functions of BP as a sleep-interfering behavior. We expect that these findings could be used in future studies and clinical settings to decrease BP. • This study tested the efficacy of a behavioral intervention for reducing bedtime procrastination (BP). • BP improved (35.56% reduction in questionnaire scores, −46.29 min average/daily) in the intervention group. • The main function of BP was emotion regulation.. [ABSTRACT FROM AUTHOR]

To evaluate the efficacy of oral administration of tranexamic acid (TXA) in spine surgery to achieve blood loss reduction. Sixty patients undergoing major surgery of the spine were randomly assigned into 2 groups. Group 1 was assigned as the control group and the other group comprised patients who received oral administration of TXA 2 hours before surgery. Outcome measures included intraoperative blood loss, postoperative blood loss, hematologic parameters, blood transfusion needed, and surgical complications. Sixty patients linked up with the inclusion criteria. Intraoperative blood loss was significantly lower in the TXA oral group than in the control group; total blood loss in the TXA group was 930.66 ± 614 mL, which was lower than in the control group, with 1075.66 ± 956.11 mL. The mean reduction of hemoglobin was almost the same in both groups. Similarly, the total transfusion package received was lower, and the number of complications and length of stay were akin in both groups. A logistic regression model was performed with patients who had blood loss >1000 mL and surgery time >230 minutes. This result was related to the risk of bleeding, with an odds ratio of 1.31, 95% confidence interval, 1.004–1.023, P = 0.004, independent of the group. Oral TXA is as an effective measure for reducing total blood loss among patients undergoing elective spine surgery. [ABSTRACT FROM AUTHOR]

Respiratory syncytial virus (RSV) infection in lung transplant recipients is associated with high morbidity. This study evaluated the RSV fusion inhibitor presatovir in RSV-infected lung transplant recipients. In this international Phase 2b, randomized, double-blind, placebo-controlled trial (NCT02534350), adult lung transplant recipients with symptomatic confirmed RSV infection for ≤7 days received oral presatovir 200 mg on day 1 and 100 mg daily on days 2 to 14, or placebo (2:1), with follow-up through day 28. There were 2 coprimary endpoints: time-weighted average change in nasal RSV load from day 1 to 7, calculated from nasal swabs, in the full analysis set ([FAS]; all patients who received study drug and had quantifiable baseline nasal RSV load) and time-weighted average change in nasal RSV load from day 1 to 7 in the subset of patients with pretreatment symptom duration at the median or shorter of the FAS. Secondary endpoints were changes in respiratory infection symptoms assessed using the Influenza Patient-Reported Outcomes questionnaire and lung function measured by spirometry. Sixty-one patients were randomized, 40 received presatovir, 20 placebo, and 54 were included in efficacy analyses. Presatovir did not significantly improve the primary endpoint in the FAS (treatment difference [95% CI], 0.10 [−0.43, 0.63] log 10 copies/ml; p = 0.72) or the shorter symptom-duration subgroup (−0.12 [−0.94, 0.69] log 10 copies/ml; p = 0.76). Secondary endpoints were not different between presatovir and placebo groups. Presatovir was generally well tolerated. Presatovir treatment did not significantly improve change in nasal RSV load, symptoms, or lung function in lung transplant recipients. [ABSTRACT FROM AUTHOR]

To test whether Bacillus Calmette-Guérin (BCG) vaccination would reduce the incidence of COVID-19 and other respiratory tract infections (RTIs) in older adults with one or more comorbidities. Community-dwelling adults aged 60 years or older with one or more underlying comorbidities and no contraindications to BCG vaccination were randomized 1:1 to BCG or placebo vaccination and followed for 6 months. The primary endpoint was a self-reported, test-confirmed COVID-19 incidence. Secondary endpoints included COVID-19 hospital admissions and clinically relevant RTIs (i.e. RTIs including but not limited to COVID-19 requiring medical intervention). COVID-19 and clinically relevant RTI episodes were adjudicated. Incidences were compared using Fine-Gray regression, accounting for competing events. A total of 6112 participants with a median age of 69 years (interquartile range, 65–74) and median of 2 (interquartile range, 1–3) comorbidities were randomized to BCG (n = 3058) or placebo (n = 3054) vaccination. COVID-19 infections were reported by 129 BCG recipients compared to 115 placebo recipients [hazard ratio (HR), 1.12; 95% CI, 0.87–1.44]. COVID-19-related hospitalization occurred in 18 BCG and 21 placebo recipients (HR, 0.86; 95% CI, 0.46–1.61). During the study period, 13 BCG recipients died compared with 18 placebo recipients (HR, 0.71; 95% CI, 0.35–1.43), of which 11 deaths (35%) were COVID-19-related: six in the placebo group and five in the BCG group. Clinically relevant RTI was reported by 66 BCG and 72 placebo recipients (HR, 0.92; 95% CI, 0.66–1.28). BCG vaccination does not protect older adults with comorbidities against COVID-19, COVID-19 hospitalization, or clinically relevant RTIs. [ABSTRACT FROM AUTHOR]

We aimed at assessing the efficacy and safety on antibiotic exposure of a strategy combining a respiratory multiplex PCR (mPCR) with enlarged panel and daily procalcitonin (PCT) measurements, as compared with a conventional strategy, in adult patients who were critically ill with laboratory-confirmed SARS-CoV-2 pneumonia. This multicentre, parallel-group, open-label, randomized controlled trial enrolled patients admitted to 13 intensive care units (ICUs) in France. Patients were assigned (1:1) to the control strategy, in which antibiotic streamlining remained at the discretion of the physicians, or interventional strategy, consisting of using mPCR and daily PCT measurements within the first 7 days of randomization to streamline initial antibiotic therapy, with antibiotic continuation encouraged when PCT was >1 ng/mL and discouraged if < 1 ng/mL or decreased by 80% from baseline. All patients underwent conventional microbiological tests and cultures. The primary end point was antibiotic-free days at day 28. Between April 20th and November 23rd 2020, 194 patients were randomized, of whom 191 were retained in the intention-to-treat analysis. Respiratory bacterial co-infection was detected in 48.4% (45/93) and 21.4% (21/98) in the interventional and control group, respectively. The number of antibiotic-free days was 12.0 (0.0; 25.0) and 14.0 (0.0; 24.0) days, respectively (difference, −2.0, (95% CI, −10.6 to 6.6), p=0.89). Superinfection rates were high (51.6% and 48.5%, respectively). Mortality rates and ICU lengths of stay did not differ between groups. In severe SARS-CoV-2 pneumonia, the mPCR/PCT algorithm strategy did not affect 28-day antibiotics exposure nor the major clinical outcomes, as compared with routine practice. [ABSTRACT FROM AUTHOR]

Randomized controlled trials (RCTs) on the efficacy of multicomponent lifestyle medicine (LM) interventions for improving sleep quality have yielded inconsistent findings. This study marks the first meta-analysis to evaluate the efficacy of multicomponent LM interventions in improving sleep quality. We searched six online databases for RCTs that compared multicomponent LM interventions to an active or inactive control group in an adult population and assessed subjective sleep quality as a primary or secondary outcome using validated sleep measures at any post-intervention time-point. A total of 23 RCTs with 26 comparisons involving 2534 participants were included in the meta-analysis. After excluding outliers, the analysis revealed that multicomponent LM interventions significantly improved sleep quality at immediate post-intervention (d = 0.45) and at short-term follow-up (i.e.,

Neovascular (wet) age-related macular degeneration (nAMD) is driven by VEGFs A, C, and D, which promote angiogenesis and vascular permeability. Intravitreal injections of anti–VEGF-A drugs are the standard of care, but these do not inhibit VEGF-C and D, which may explain why many patients fail to respond fully. This trial aimed to test the safety and efficacy of OPT-302, a biologic inhibitor of VEGF-C and D, in combination with the anti–VEGF-A inhibitor ranibizumab. Dose-ranging, phase 2b, randomized, double-masked, sham-controlled trial. Participants with treatment-naive nAMD were enrolled from 109 sites across Europe, Israel, and the United States. Participants were randomized to 6, 4-weekly, intravitreal injections of 0.5 mg OPT-302, 2.0 mg OPT-302, or sham, plus intravitreal 0.5 mg ranibizumab. The primary outcome was mean change in ETDRS best-corrected visual acuity (BCVA) at 24 weeks. Secondary outcomes (comparing baseline with week 24) were the proportion of participants gaining or losing ≥ 15 ETDRS BCVA letters; area under the ETDRS BCVA over time curve; change in spectral-domain OCT (SD-OCT) central subfield thickness; and change in intraretinal fluid and subretinal fluid on SD-OCT. Of 366 participants recruited from December 1, 2017, to November 30, 2018, 122, 123, and 121 were randomized to 0.5 mg OPT-302, 2.0 mg OPT-302, and sham, respectively. Mean (± standard deviation) visual acuity gain in the 2.0 mg OPT-302 group was significantly superior to sham (+14.2 ± 11.61 vs. +10.8 ± 11.52 letters; P = 0.01). The 0.5 mg OPT-302 group was not significantly different than the sham group (+9.44 ± 11.32 letters; P = 0.83). Compared with sham, the secondary BCVA outcomes favored the 2.0 mg OPT-302 group, with structural outcomes favoring both OPT-302 dosage groups. Adverse events (AEs) were similar across groups, with 16 (13.3%), 7 (5.6%), and 10 (8.3%) participants in the lower-dose, higher-dose, and sham groups, respectively, developing at least 1 serious AE. Two unrelated deaths both occurred in the sham arm. Significantly superior vision gain was observed with OPT-302 2.0 mg combination therapy, versus standard of care, with favorable safety (ClinicalTrials.gov identifier: NCT03345082). Proprietary or commercial disclosure may be found after the references. [ABSTRACT FROM AUTHOR]

To examine the effectiveness of a 12-month MHBC intervention in the prevention of onset depression in primary health care (PHC). Twenty-two PHC centres took part in the cluster-randomized controlled trial. Patients were randomized to receive either usual care or an MHBC intervention. The endpoints were onset of major depression and reduction of depressive symptoms in participants without baseline depression at a 12-month follow-up. 2531 patients agreed and were eligible to participate. At baseline, around 43% were smokers, 82% were non-adherent to the Mediterranean diet and 55% did not perform enough physical activity. The intervention group exhibited a greater positive change in two or more behaviours (OR 1.75 [95%CI: 1.17 to 2.62]; p = 0.006); any behaviour (OR 1.58 [95%CI: 1.13 to 2.20]; p = 0.007); and adherence to the Mediterranean diet (OR 1.94 [95%CI: 1.29 to 2.94]; p = 0.002), while this increase was not statistically significant for smoking and physical activity. The intervention was not effective in preventing major depression (OR 1.17; [95% CI 0.53 to 2.59)]; p = 0.690) or reducing depressive symptoms (Mean difference: 0.30; [95% CI -0.77 to 1.36]; p = 0.726) during follow-up. As compared to usual care, the MHBC intervention provided a non-significant reduction in the incidence of major depression. Trial registration: ClinicalTrials.gov , NCT03136211. • Health behaviour may be involved in the onset of depressive disorders. • Multiple health behaviour change (MHBC) interventions can be implemented in primary health care (PHC) to prevent depression. • The MHBC intervention tested was not effective in preventing major depression and in reducing depressive symptoms in PHC. • More studies are needed to draw robust conclusions about the implementation of MHCB interventions to prevent depression. [ABSTRACT FROM AUTHOR]

Background Context: Currently, there are no published studies that compare non-pharmacological, pharmacological and invasive treatments for chronic low back pain in adults and provide summary statistics for benefits and harms.Purpose: The aim of this review was to compare the benefits and harms of treatments for the management of chronic low back pain without radiculopathy and to report the findings in a format that facilitates direct comparison (Benefit-Harm Scale: level 1 to 7).Design: Systematic review and meta-analysis of randomized controlled trials, including trial registries, from electronic databases up to 23rd May 2022.Patient Sample: Adults with non-specific chronic low back pain, excluding radicular pain in any clinical setting.Outcome Measures: Comparison of pain at immediate-term (≤2 weeks) and short-term (>2 weeks to ≤12 weeks) and serious adverse events using the Benefit-Harm Scale (level 1 to 7).Methods: This was a registered systematic review and meta-analysis of randomized controlled trials. Interventions included non-pharmacological (acupuncture, spinal manipulation only), pharmacological and invasive treatments compared to placebo. Best evidence criteria was used. Two independent reviewers conducted eligibility assessment, data extraction and quality appraisal.Results: The search retrieved 17,362 records. Three studies provided data on the benefits of interventions, and 30 provided data on harms. Studies included interventions of acupuncture (n = 8); manipulation (n = 2); pharmacological therapies (n = 9), including NSAIDs and opioid analgesics; surgery (n = 8); and epidural corticosteroid injections (n = 3). Acupuncture (standardized mean difference (SMD) -0.51, 95%CI -0.88 to -0.14, n = 1 trial, moderate quality of evidence, benefit rating of 3) and manipulation (SMD -0.39 (96%CI -0.56 to -0.21, n = 2 trials, moderate quality of evidence, benefit rating of 5) were effective in reducing pain intensity compared to sham. The benefit of the other interventions was scored as uncertain due to not being effective, statistical heterogeneity preventing pooling of effect sizes, or the absence of relevant trials. The harms level warnings were at the lowest (e.g. indicating rarer risk of events) for acupuncture, spinal manipulation, NSAIDs, combination ingredient opioids, and steroid injections, while they were higher for single ingredient opioid analgesics (level 4) and surgery (level 6).Conclusions: There is uncertainty about the benefits and harms of all the interventions reviewed due to the lack of trials conducted in patients with chronic non-specific low back pain without radiculopathy. From the limited trials conducted, non-pharmacological interventions of acupuncture and spinal manipulation provide safer benefits than pharmacological or invasive interventions. However, more research is needed. There were high harms ratings for opioids and surgery.Registration: This review was registered on the International Prospective Register of Systematic Reviews. [ABSTRACT FROM AUTHOR]

The best management for acute basilar artery occlusion (BAO) has increasingly been clarified by recent randomized controlled trials (RCTs). We conducted a systematic review and meta-analysis of RCTs comparing endovascular therapy (EVT) vs best medical management (BMM). We searched PubMed, Embase, the CENTRAL, and ClinicalTrials.gov from January 1, 2000, to November 20, 2022. We included RCTs comparing EVT vs BMM in BAO or bilateral vertebral artery occlusion (VAO). Primary outcome was ambulation (modified Rankin Scale score [mRS] 0–3) at 90 days. Secondary outcomes were independence (mRS 0–2) at 90 days, death by 90 days, and symptomatic intracranial hemorrhage (sICH). Risk ratio (RR) with 95% CI was used as a measure of the association of EVT vs BMM with outcomes. Final analyses included 4 RCTs with 988 patients with BAO or VAO. Pooled results showed that EVT vs BMM was associated with an increased rate of 90-day ambulation (RR 1.54, 95% CI 1.16–2.05), independence (RR 1.83, 1.08–3.08) and a reduced risk of mortality (RR 0.76, 0.65–0.89), but an increased risk of sICH (RR 7.48, 2.27–24.62) and the benefits might be confined to patients with BAO but not patients with VAO. EVT effect was modified by occlusion location with the basilar artery, with greatest benefit for proximal, intermediate benefit for middle, and least benefit for distal occlusions. EVT compared with BMM might be associated with an increased rate of ambulation, independence and survival but with an increased risk of sICH in patients with acute BAO. [ABSTRACT FROM AUTHOR]

Purpose: This study was to test the hypothesis that intramedullary (IM) nailing fixation of midshaft clavicle fractures could result in better clinical outcomes and lower complications rates than plating fixation.Methods: PubMed, Embase, and the Cochrane Library database were used to search all English language published randomized controlled trials (RCTs) of midshaft clavicle fractures using plating versus IM nailing. The characteristics of the study participants were collected. Outcomes of postoperative shoulder functional measurements, operative data and complications rates were meta-analyzed.Results: Eight hundred and ninety-five patients in ten RCTs and three quasi-RCTs were involved in the meta-analysis. The results of meta-analysis of these studies showed that the functional outcome evaluated by the Constant Shoulder and Disabilities of the Arm, Shoulder and Hand (DASH) scores after accepting IM nailing was significantly better than that of plating fixation at one year post-operatively (P < 0.01), with the heterogeneity of 43% and 91%, respectively. Sensitivity analyses of the pooled results of Constant and DASH scores displayed that the functional advantage of IM nailing fixation comes from the subgroup of locked IM nailing. Further, regarding the operative statistics, operative time, blood loss and wound length were significantly less in the IM nailing group than the plating group (P < 0.001). The rates of infection, major complications and complications-related revision surgery were significantly higher in the plating group than the IM nailing group; however, there were no significantly statistical differences in other complications, e.g., nonunion, refracture after hardware removal, implant failure, symptomatic hardware, etc. (P > 0.05).Conclusion: The observations in this review suggested that IM nailing, especially locked IM nailing, could provide better shoulder functional outcome at one-year follow-up. Moreover, IM nailing fixation could effectively reduce operative time, blood loss, rates of infection, major complications, and revision surgery than plating. Further high-quality clinical trials with large samples and consistent designs are still needed to verify the long-term functional advantage of locked and unlocked IM nailing for midshaft clavicle fractures.Level Of Evidence: Level II. [ABSTRACT FROM AUTHOR]

A generalized proinflammatory state has been observed in individuals with panic disorder (PD). There is evidence that slow-paced breathing (SPB) with heart rate variability-biofeedback (HRV-BF) strengthens the nervus vagus with its anti-inflammatory pathway. Therefore, with this randomized controlled trial we aimed to investigate the effect of a four-week SPB with HRV-BF intervention on pro-inflammatory cytokines in people with PD. Fifty-five individuals with PD (mean age: 37.22 ± 15.13 years) were randomly allocated either to SPB-HRV-BF (intervention group) or to HRV-Sham-BF (active control group). SPB-HRV-BF was performed over four weeks while cytokine concentration and HRV during a short-term resting condition were measured before and after intervention. SPB-HRV-BF decreased concentration of Tumor Necrosis Factor alpha (TNF-alpha) (F (1, 53) = 4.396, p ≤.05, η2 = 0.077) in individuals with PD. In addition, SPB-HRV-BF demonstrated an increase in the HRV-time and frequency domain parameters SDNN, Total Power and LF during short-term resting condition. There was no intervention effect in HRV-Sham-BF group. In conclusion, SBP-HRV-BF as a non-pharmacological treatment may reduce pro-inflammatory cytokine TNF-alpha via the cholinergic anti-inflammatory pathway in individuals with PD. Based on the generalized proinflammatory state in PD, decreasing TNF-alpha is highly beneficial to reduce risk of cardiovascular diseases and metabolic syndrome. • Decrease of TNF-alpha concentration through SPB with HRV-BF in individuals with panic disorder • Increase in vagally-mediated heart rate variability after four-weeks of SPB with HRV-BF in individuals with panic disorder • Further support for the cholinergic anti-inflammatory pathway through SPB with HRV-BF [ABSTRACT FROM AUTHOR]

Most randomized controlled trials (RCTs) of mood and anxiety disorders employ solely quantitative methods. Supplementing quantitative data with qualitative methods, a so-called mixed-method approach, would seem useful, however this area has not been rigorously reviewed. We undertook a systematic review of RCTs of mood and anxiety disorders that employed concurrent quantitative data collection and qualitative methods exploring the participants' perspective, with the aim of 1. determining the number of such studies, 2. describing study characteristics, and 3. identifying potential advantages of a mixed-method approach. Following PRISMA guidelines, a systematic literature search for RCTs of mood and anxiety disorders, concurrently applying quantitative and qualitative methods, was conducted using EMBASE, PsycINFO and Pubmed, from their inception to February 2021. Categories of potential advantages of this mixed method approach were developed. A total of 45 RCTs were included. The qualitative components typically included 10–40 participants, mostly consisting of interviews after the intervention. The majority of papers did not state a specific rationale for using a mixed method approach. Four categories of advantages emerged: 1. determine acceptability/feasibility , 2. investigate efficacy , 3. inform implementation in clinical practice and 4. generate new hypotheses based on the combination of quantitative and qualitative data. Lack of cross-referencing and consistent terminology challenged identification of relevant publications. There are a number of potential advantages of applying mixed method approaches in RCTs within psychiatric research. Intentional consideration of such advantages early in trial design may increase the likelihood of gaining added value. • Limited publications of qualitative research concurrently combined with RCTs • Qualitative data can strengthen quantitative findings of RCTs within psychiatry. • 4 categories of advantages were identified embedding qualitative research in RCTs. [ABSTRACT FROM AUTHOR]

• Insight in treatment process provided by weekly comparison of participating groups. • Specific treatment effect by cue exposure and self-control on binge-eating disorder. • Strong effect of the IMPULS program on the reduction of binge-eating episodes. • IMPULS program identified as very helpful with high participant satisfaction. • Reduction of other impulsive behaviors across groups due to weekly self-observations. Impulsivity represents a risk factor for patients with binge-eating disorder, and we therefore investigated the treatment process of impulsive behaviors including binge-eating episodes in the randomized controlled IMPULS trial. Using 8 weekly online questionnaires throughout the assessment period, we compared 41 patients participating in the IMPULS program, which emphasized impulsive eating behavior (IG), with 39 control patients who received no intervention (CG). We assessed the frequency of binge eating, other impulsive behaviors, situations in which such behaviors could be inhibited, and the execution of alternative behaviors. Results indicate a stronger binge-eating reduction in the IG compared to the CG at the fifth, seventh, and eighth treatment weeks. Overall, both groups reduced other impulsive behaviors. They did not differ in the amount of inhibited impulsive behaviors and showed similar alternative behaviors, "distraction" most frequently used. IG patients evaluated the IMPULS program as very helpful. The stronger reduction of binge eating in the IG and positive evaluation of the treatment indicate a specific treatment effect regarding impulsive eating behavior. The reduction of other impulsive behaviors across both groups, and the initial reduction of binge eating within the CG, could be explained by an increased degree of self-observation. [ABSTRACT FROM AUTHOR]

Seizures are suspected to be side effects of antipsychotics. To examine a possible causal relationship, we compared the risk of seizures on second-generation antipsychotics to the risk on placebo in randomized controlled clinical trials (RCTs) across diagnostic groups. The primary outcome was any seizure reported as International Conference on Harmonisation-Good Clinical Practice (ICH-GCP)-defined serious adverse event (SAEs). The risk ratio (RR) with antipsychotics versus placebo was synthesized in a pairwise common effects Mantel-Haenszel meta-analysis. For 314 of 597 idenitified placebo-controlled RCTs information about all SAEs could be retrieved from publications, original investigators, pharmaceutical companies and the European Medical Agency. In those, 37 seizures occurred in 42,600 participants on antipsychotics (0.09%) and 28 in 25,042 participants on placebo (0.11%). The meta-analytic results (RR 0,68; 95% Confidence Interval 0.41-1.12) indicated a reduced risk on antipsychotics with a confidence interval including no difference (i.e. RR=1). Neither in sensitivity analyses (excluding events in the safety-follow-up of trials or first-generation antipsychotics; using odds ratios) nor in subgroup analyses (on specific antipsychotics, drug combinations, diagnostic categories, age groups, and study duration) there was evidence for an increased risk on antipsychotics, except for some weak indications of an increased risk on antipsychotics in older and/or demented participants (RRs 1.11 and 1.48, respectively, but with 95% CIs of 0.35-3.49 and 0.41-5.26 including no difference and subgroup tests with p=0.54 and p=0.66 not indicating differences between age groups or diagnostic categories). Consequently, there are no indications that second-generation antipsychotics cause seizures in middle-aged adults and children in most diagnostic groups; rather our results provide some weak evidence for a protective effect. However, there was no data on SAEs available for clozapine, for which observational studies provide the strongest associations with increased seizure rates, and for older and/or demented patients a small additional risk on antipsychotics cannot be excluded. [ABSTRACT FROM AUTHOR]

Abortion is a stressful life event associated with wide variability in women's perceptions and adjustment. There is scarce evidence on interventions to help women cope with abortion and achieve positive psychological health outcomes. This study tested the effect of a stress and coping theory-formed intervention (START) on depression and coping of Chinese women undergoing a first-trimester abortion. A randomized controlled trial was conducted at a Chinese metropolitan hospital. 110 participants were recruited and randomized to intervention group (START + standard care) or control group (standard care) with a 1:1 allocation ratio. The primary outcome was depression at two-week post-abortion. Surveys were completed by participants when they sought abortion services (baseline), two and six-week post-abortion. At two-week post-abortion, women allocated to the intervention group compared to the control group, had significantly lower depression scores (aOR −2.81 [−4.12 to −1.50]), higher problem-focused coping (aOR 1.64 [0.36–2.93]), lower dysfunctional coping (aOR −2.29 [−3.69 to −0.89]), higher self-efficacy (aOR 3.17 [−0.42–5.94]), and higher personal growth scores (aOR 4.41 [0.30–8.53]). Lower depression scores at two-weeks were mediated by lower dysfunctional coping (mediated effect 0.96 [0.25, 1.74]; proportion of overall effect 36 % [9 %, 65 %]). Chinese women allocated to receive START had lower depression and better coping at two-week post-abortion. This brief, online intervention contributed to women's self-efficacy and positive perceptions of social support, abortion experience, and personal growth. Maintenance of the effects need further research. • Evidence on psychological interventions to help women cope with abortion is scarce. • A theory-in formed intervention (START) is effective in mitigating depression and improving coping at two-week post-abortion. • The effect of START on reducing depression was mediated by the decreased dysfunctional coping behaviours. • An adequately powered RCT with longer follow-up and multi-center involvement is necessary to draw definite conclusions. [ABSTRACT FROM AUTHOR]

Social anxiety is associated with diminished automatic approach toward positive social cues that may limit the ability to connect with others. This diminished approach bias may be a modifiable treatment target. We evaluated the effects of an approach avoidance training procedure on positive emotions, social relationship outcomes, clinical symptoms, and neural indices of social approach and reward processing. Forty-five individuals with social anxiety disorder were randomized (parallel 1:1 randomization) to complete computerized Approach Positive training (n = 21) or Balanced training(n = 24). Sessions included a standardized social interaction task. Participants were blind to training group. Participants completed clinical outcome measures and functional magnetic resonance imaging at baseline and post intervention with an MRI-compatible AAT and the social incentive delay task (SID). Both groups displayed significant improvements of similar magnitude on the primary outcome of social connectedness (between group post-treatment d = −0.21) but not positive affect (d = −0.09), from before to after treatment, persisting through follow-up. Groups demonstrated significant improvements on additional outcomes including anxiety, depression, and anhedonia symptoms. Participants in Approach Positive AAT demonstrated increased activation in the thalamus and medial prefrontal cortex during social versus neutral- approach relative to Balanced AAT during the fMRI AAT. Participants in Balanced AAT showed increased activation in regions within an a priori-defined striatum region of interest mask during anticipation of social reward (vs. baseline) in the SID relative to Approach Positive AAT. At a neural processing level AAT may influence the valuation and motivations associated with positive social cues regulated by the mPFC and thalamus. NCT02136212 , NIMH R00MH090243. • Approach bias training with social interaction was compared to a control. • Both groups showed reductions in symptoms over time. • Differential neural response between groups was observed. [ABSTRACT FROM AUTHOR]

We explored whether a new combination of eye mask sleep position therapy (SPT) and oral appliance therapy (OAT) was more effective at treating positional obstructive sleep apnea (POSA) than was the use of either device alone. In this randomized controlled trial, 60 POSA subjects diagnosed by standard polysomnography (PSG) were divided into three groups (ratio 1:1:1): SPT, OAT, and SPT combined with OAT (SOT). Participants underwent hospital-based follow-ups during months 1 and 6 after beginning treatment. The primary outcome was the decline in the apnea hypopnea index (AHI) at month 6. The secondary outcomes were changes in oxygen-derived parameters and the curative effect at month 6. After 6 months of treatment, PSG showed that SPT, OAT, and SOT all improved the AHI and oxygen-derived parameters. The AHI decline was significantly better in the SOT group than in the OAT or SPT group (71.58% [50.56–84.84%] for SOT, 44.42% [21.23–67.52%] for OAT, and 33.24% [19.03–54.62%] for SPT at 6 months) (P = 0.018 and P < 0.001 for the comparisons of SOT with OAT and SOT with SPT, respectively). In terms of oxygen-derived parameters, only the sleep apnea-specific hypoxic burden (SASHB) improved more in the SOT group (76.89% [57.43–85.91%]) than in the other groups (44.73% [32.38–72.69%] for OAT and 41.82% [15.40–65.24%] for SPT, P = 0.002 and P < 0.001 for the comparisons of SOT with OAT and SOT with SPT, respectively). The efficacies of SPT, OAT, and SOT were 36.84%, 50%, and 80% at 6 months; the SOT group evidenced the highest value (rate ratio [95% confidence interval] 1.78 (1.05–3.03), P = 0.048 and 2.17 (1.16–4.07), P = 0.010, for the comparisons of SOT with OAT and SOT with SPT, respectively). The combination of SPT and OAT was better than either treatment alone and may represent a good option for the treatment of POSA. Chinese Clinical Trial Registry; URL: http://www.chictr.org.cn/showproj.aspx?proj=42,852 ; No. ChiCTR1900025584. • Novel sleep position therapy and oral appliance therapy were effective for positional obstructive sleep apnea. • The combination of these two devices was better than the use of either alone in improving AHI and SASHB. • The combination of the two methods may represent a good option for the treatment of positional obstructive sleep apnea. [ABSTRACT FROM AUTHOR]

To define the effect of symptom duration on outcomes in people undergoing surgery for idiopathic full-thickness macular holes (iFTMHs) by means of an individual participant data (IPD) study of randomized controlled trials (RCTs). The outcomes assessed were primary iFTMH closure and postoperative best-corrected visual acuity (BCVA). Idiopathic full-thickness macular holes are visually disabling with a prevalence of up to 0.5%. Untreated BCVA is typically reduced to 20/200. Surgery can close holes and improve vision. Symptom duration is thought to affect outcomes with surgery, but the effect is unclear. A systematic review identified eligible RCTs that included adults with iFTMH undergoing vitrectomy with gas tamponade in which symptom duration, primary iFTMH closure, and postoperative BCVA were recorded. Bibliographic databases were searched for articles published between 2000 and 2020. Individual participant data were requested from eligible studies. Twenty eligible RCTs were identified. Data were requested from all studies and obtained from 12, representing 940 eyes in total. Median symptom duration was 6 months (interquartile range, 3–10). Primary closure was achieved in 81.5% of eyes. There was a linear relationship between predicted probability of closure and symptom duration. Multilevel logistic regression showed each additional month of duration was associated with 0.965 times lower odds of closure (95% confidence interval [CI], 0.935–0.996, P = 0.026). Internal limiting membrane (ILM) peeling, ILM flap use, better preoperative BCVA, face-down positioning, and smaller iFTMH size were associated with increased odds of primary closure. Median postoperative BCVA in eyes achieving primary closure was 0.48 logarithm of the minimum angle of resolution (logMAR) (20/60). Multilevel logistic regression showed for eyes achieving primary iFTMH closure, each additional month of symptom duration was associated with worsening BCVA by 0.008 logMAR units (95% CI, 0.005–0.011, P < 0.001) (i.e., ∼1 Early Treatment Diabetic Retinopathy Study letter loss per 2 months). ILM flaps, intraocular tamponade using long-acting gas, better preoperative BCVA, smaller iFTMH size, and phakic status were also associated with improved postoperative BCVA. Symptom duration was independently associated with both anatomic and visual outcomes in persons undergoing surgery for iFTMH. Time to surgery should be minimized and care pathways designed to enable this. [ABSTRACT FROM AUTHOR]

This study aimed to conduct a scoping review of randomized controlled trials (RCTs) and investigate which work productivity loss outcomes were measured in these RCTs, how each outcome was measured and analyzed, and how the results for each outcome were presented. A systematic search was conducted from January 2010 to April 2020 from 2 databases: PubMed and Cochrane Central Register of Controlled Trials. Data on country, study population, disease focus, sample size, work productivity loss outcomes measured (absenteeism, presenteeism, employment status changes), and methods used to measure, report, and analyze each work productivity loss outcome were extracted and analyzed. We found 435 studies measuring absenteeism or presenteeism, of which 155 studies (35.6%) measured both absenteeism and presenteeism and were included in our final review. Only 9 studies also measured employment status changes. The most used questionnaire was the Work Productivity and Activity Impairment Questionnaire. The analysis of absenteeism and presenteeism data was mostly done using regression models (n = 98, n = 98, respectively) for which a normal distribution was assumed (n = 77, n = 89, respectively). Absenteeism results were most often presented in time whereas presenteeism was commonly presented using a percent scale or score. There is a lack of consensus on how to measure, analyze, and present work productivity loss outcomes in RCTs published in the past 10 years. The diversity of measurement, analysis, and presentation methods used in RCTs may make comparability challenging. There is a need for guidelines providing recommendations to standardize the comprehensiveness and the appropriateness of methods used to measure, analyze, and report work productivity loss in RCTs. • Increasingly, randomized controlled trials (RCTs) are incorporating work productivity loss as a patient-centered outcome. Previous literature has focused on assessing measurement properties of various questionnaires used to measure work productivity loss. Nevertheless, little is known about current research practices in terms of which work productivity loss outcomes are measured (absenteeism, presenteeism, and employment status changes) and how they are measured, analyzed, and presented in RCTs among broader populations including employees, patients, and caregivers. • We found 435 studies measuring absenteeism or presenteeism. Among them, 155 (35.6%) measured both, and only 9 studies also measured employment status changes. The most used questionnaire was the Work Productivity and Activity Impairment Questionnaire. Despite their skewed distribution with many zeros, absenteeism and presenteeism were commonly analyzed with models that assume they follow a normal distribution. Absenteeism results were most often presented in time, whereas presenteeism was commonly presented using a percent scale or score. • RCTs are measuring work productivity loss as a patient-centered outcome or a cost component for economic evaluations. The results of RCTs and economic evaluations are critical in informing healthcare decision makers for their funding decisions. Our review suggests that most RCTs partially measured work productivity loss and may not analyze the data with statistically appropriate methods, which may result in reporting underestimated loss and biased treatment effects. The diverse methods used in RCTs make comparability challenging. [ABSTRACT FROM AUTHOR]

Psychotic depression has a high rate of relapse. The study aims were to identify a prediction model of risk of relapse of psychotic depression and examine whether predictors moderated the effect of treatment on relapse. One hundred and twenty-six men and women aged 18–85 years, who experienced sustained remission or near-remission of psychotic depression with sertraline plus olanzapine, participated in a 36-week randomized controlled trial that compared sertraline plus olanzapine with sertraline plus placebo in preventing relapse (NCT01427608). Cox regression analyses were performed to identify significant predictors of relapse and to model the combined role of significant predictors. Concordance statistic was calculated to determine the accuracy of the best fit multivariable models in predicting relapse. Finally, interaction terms were tested for each significant predictor to examine whether they moderated the effect of treatment on risk of relapse. Lifetime number of depressive episodes, severity of residual depressive symptoms at the time of randomization, and psychomotor disturbance both at acute enrollment when participants were depressed and at the time of randomization predicted risk of relapse. Multivariable models had 69–70% accuracy in predicting relapse. Psychomotor disturbance was associated with increased risk of relapse in the sertraline plus olanzapine group compared with sertraline plus placebo, whereas the other predictors did not moderate the effect of treatment on relapse. Future research is needed to determine whether a combination of clinical and biological variables can further increase the accuracy of prediction of relapse of psychotic depression. • Psychotic depression has a high rate of relapse. • Identify predictors and moderators of risk of relapse of remitted psychotic depression. • Lifetime number of depressive episodes, residual depressive symptoms, and psychomotor disturbance predicted relapse. • Multivariable models had 69–70% accuracy in predicting relapse. • Psychomotor disturbance moderated the effect of randomized treatment on relapse. [ABSTRACT FROM AUTHOR]

Background: Research shows that family involvement in psychosis treatment leads to better patient outcomes. Interventions that involve and counsel family members may improve patient outcomes by addressing barriers to treatment adherence and lowering family expressed emotion, thereby creating a less stressful and more supportive home environment. Learning to use motivational interviewing communication skills may help caregivers to decrease conflict and expressed emotion and improve treatment adherence.Methods: The current study is a pilot randomized controlled trial testing the impact of "Motivational Interviewing for Loved Ones" (MILO), a brief five-hour psychoeducational intervention for caregivers, in a sample of family members of individuals with early course psychosis (N = 40). Using a randomized crossover design, caregivers were randomized to either immediate MILO or a six-week waitlist control condition; all participants eventually received the intervention.Results: Caregiver participants experienced large (d = 1.08-1.43) and significant improvements in caregiver wellbeing, caregiver self-efficacy, family conflict, and expressed emotion. There was no change over time in caregiver-reported patient treatment adherence. Relative to waitlist, MILO had significant effects on family conflict and expressed emotion, a trending effect on perceived stress, and no effect on parenting self-efficacy or treatment adherence.Conclusions: MILO showed benefits for caregivers of FEP patients in this small, controlled trial. Further testing in a larger randomized controlled trial is warranted to better characterize MILO's effects for caregivers and patients across a range of diagnoses. [ABSTRACT FROM AUTHOR]

Introduction: and objective: Tremor is a disabling symptom of PD that usually responds poorly to available standard pharmacological agents. This study aimed to assess the effect of Zonisamide 25 mg on tremor in tremor-dominant PD patients as compared to placebo.Methods: This was a randomized, placebo-controlled, double-blind study. Parkinson's disease patients were allocated either to the intervention group (standard treatment along with Zonisamide 25 mg add-on) or the placebo group (standard treatment along with placebo). Baseline Unified Parkinson's Disease Rating Scale (UPDRS) and Tremor Research Group Essential Tremor Rating Scale (TETRAS) scores, as well as accelerometric tremor analysis were done and follow-up assessments of the same were done after 12 weeks of intervention. Percentage change from baseline in the UPDRS tremor score was the primary outcome whereas percentage change from baseline of total UPDRS score, UPDRS rigidity and bradykinesia scores, TETRAS score, and accelerometric tremor analysis values were the secondary outcomes.Results: There was no significant difference in the percentage change from baseline UPDRS tremor scores between the two groups (placebo: 8.33 [-19.89-23.86] vs drug: 26.14 [-35.58 to -16.07], p-value: 0.164, CI: 0.157-0.171). Best-case analysis for missing values showed a significant improvement in the drug group, compared to the placebo group (p-value: < 0.001, CI: <0.001 - <0.001).Conclusion: Zonisamide at a dose of 25 mg per day did not improve tremor in tremor-dominant PD patients, however, a positive trend was seen as compared to Placebo in the UPDRS tremor score. Larger studies are required to confirm this finding. [ABSTRACT FROM AUTHOR]

Few clinical trials have evaluated the efficacy of psychotherapy for Intermittent Explosive Disorder (IED). The present study tested the efficacy of a cognitive behavioral intervention (versus supportive psychotherapy) among adults with IED. In this randomized clinical trial, 44 participants with IED (22 men and 22 women) aged 20-55 years completed twelve 50-minute individual sessions of either a multi-component cognitive behavioral intervention for IED (n = 19) or a time equated supportive psychotherapy (n = 25). At baseline, posttreatment, and 3-month follow-up, all participants received the Overt Aggression Scale-Modified, which was conducted by an interviewer who was blind to the participant's study condition. During these visits, participants also completed self-report measures of relational aggression (Self-Report of Relational Aggression and Social Behavior), anger (State-Trait Anger Expression Inventory-2), cognitive biases (e.g., Social Information Processing Questionnaire Attribution and Emotional Response Questionnaire), and associated symptoms (e.g., Beck Depression Inventory). Primary study outcomes were aggressive behavior and anger. Though participants in both treatments tended to improve over time, the cognitive behavioral intervention was superior to supportive psychotherapy in decreasing aggressive behavior and relational aggression. These findings support the efficacy of a multicomponent cognitive behavioral intervention in treating aggression in IED. [ABSTRACT FROM AUTHOR]

Objective: Computer-assisted child-focused interventions are expected to improve efficiency and personalization of therapist-led treatments for children and adolescents. However, therapist-led, outpatient interventions using computer assistance are lacking for children with oppositional defiant disorder (ODD) or conduct disorder (CD). The present randomized controlled trial examined the efficacy of individualized computer-assisted social skills training for children with aggressive behavior compared to a resource activation intervention.Method: A total of 100 children aged 6-12 years with a diagnosis of ODD/CD and peer-related aggression were randomly (1:1) assigned to either individually delivered computer-assisted social skills training (ScouT) or an individually delivered supportive resource activation treatment (STARK). The primary outcome was parent-rated peer-related aggression, assessed with the respective scale of the Questionnaire for Aggressive Behavior of Children (FAVK) and measured at pre-assessment and after the 16-week intervention (post-assessment). Further parent-, self-, teacher- and/or clinician-rated outcomes included ODD and CD symptoms, a wide range of behavioral and emotional symptoms, callous-unemotional traits, functional impairment, and quality of life.Results: After correcting for multiple testing, analyses of covariance comparing the efficacy of ScouT to the efficacy of STARK yielded small to moderate treatment effects in favor of the ScouT condition regarding parent-rated peer-related aggression (primary outcome; d = -0.64, 95% CI = -1.05, -0.24), parent-rated callous and uncaring traits, and parent-rated quality of life. However, the analyses did not reveal any significant effects for self- or teacher-rated peer-related aggression assessed with the respective scale of the FAVK (self-report: d = -0.21, 95% CI = -0.69, 0.29; teacher rating: d = -0.17, 95% CI = -0.56, 0.22). Moreover, after controlling for multiple comparisons, no significant effects emerged for the following: parent-, self-, and teacher-rated adult-related aggression; parent-, self-, teacher-, and clinician-rated ODD and CD symptoms; parent-, self-, and teacher-rated emotional and behavioral symptoms; and parent-rated functional impairment.Conclusion: According to parent ratings, school-age children with disruptive behavior disorders and peer-related aggression seem to benefit more from individualized, computer-assisted social skills training than from resource activation treatment. However, this conclusion is limited by the missing effects on the clinician-, self-, and teacher-rated measures.Clinical Trial Registration Information: Treatment of Children With Peer Related Aggressive Behavior (ScouT); https://clinicaltrials.gov/; NCT02143427. [ABSTRACT FROM AUTHOR]

Background: Vitamin D status and requirements of infants of women with gestational diabetes mellitus (GDM) are unclear.Objectives: The objectives were to assess vitamin D status in infants of mothers with GDM and compare vitamin D status in response to 400 vs. 1000 IU/d vitamin D supplementation in infants born with serum 25-hydroxyvitamin D [25(OH)D] <50 nmol/L.Methods: Women with GDM delivering full-term infants (n = 98; March 2017-2019, Montreal, Canada) were surveyed for demographic and lifestyle factors. Pregnancy history was obtained from medical records. Newborn serum 25(OH)D was measured (immunoassay) and categorized as <30 (deficient) or ≥40 nmol/L (adequate). Breastfed neonates (n = 16) with serum 25(OH)D <50 nmol/L at birth were randomly assigned to 400 or 1000 IU/d of supplemental cholecalciferol (vitamin D3), and serum 25(OH)D was measured at baseline (≤1 mo) and 3, 6, and 12 mo of age. Groups were compared using a linear mixed-effects model and Tukey-Kramer post hoc tests.Results: Mean newborn serum 25(OH)D was 46.4 (95% CI: 43.9, 49.9) nmol/L, with 15.3% (95% CI: 8.2%, 22.4%) <30 nmol/L and 61.2% (95% CI: 51.6%, 70.9%) ≥40 nmol/L. During the trial, most infants were breastfed to 3 mo (400 IU/d: 87.5%; 1000 IU/d: 75.0%). Mean (± SEM) infant serum 25(OH)D was higher in the 1000-IU/d group at 3 mo (79.9 ± 5.9 vs. 111.5 ± 15.2 nmol/L; P = 0.0263), and although not different at 6-12 mo, was maintained at >50 nmol/L.Conclusions: Most infants of women with GDM had adequate vitamin D status in this study. In those born with serum 25(OH)D <50 nmol/L, vitamin D status was corrected by 3 mo of age in response to 400 or 1000 IU/d of supplemental vitamin D. Dietary guidance should continue to recommend that all women who could become pregnant take a multivitamin supplement and that breastfed infants receive 400 IU/d of supplemental vitamin D. This study and ancillary trial were registered at clinicaltrials.gov (https://www.clinicaltrials.gov/ct2/show/NCT02563015) as NCT02563015. [ABSTRACT FROM AUTHOR]

Several previous meta-analyses have been published, followed by additional randomized clinical trials investigating the effects of tranexamic acid (TXA) in patients undergoing posterior lumbar interbody fusion (PLIF) surgery. As a result, the purpose of this research is to present an updated quantitative analysis of the existing literature and to further explicate its effectiveness. PubMed, Embase, Web of Science, and Cochrane Library databases were searched for randomized controlled trials (RCTs) comparing the application of TXA and placebo in patients undergoing PLIF surgery from their establishment to December 31, 2021. Data on clinical outcomes, perioperative outcomes, and complications were collected. The summary statistics for continuous and dichotomous variables were derived as weighted mean difference (WMD) and relative risk (RR), respectively. A total of 12 studies enrolling 1088 participants were included in this meta-analysis. The combined results revealed that TXA can decrease intraoperative blood loss (WMD: −84.83, P < 0.0001), total blood loss (WMD: −189.93, P < 0.00001), hidden blood loss (WMD: −134.69, P = 0.002), postoperative drainage (WMD: −100.71, P < 0.00001), postoperative hemoglobin loss (WMD: 6.21, P < 0.00001), operative time (WMD: −3.80, P = 0.007), hospital stay (WMD: −1.86, P = 0.001), and transfusion rates (RR: 0.41, P < 0.00001) in PLIF without increasing the risk of thromboembolic events (RR: 0.80, P = 0.43). TXA can considerably decrease surgical blood loss, postoperative drainage, reduce operative times, hospital stays, and transfusion rates. Furthermore, the TXA group had lower postoperative hemoglobin drop values than the placebo group. [ABSTRACT FROM AUTHOR]

The role of tranexamic acid (TXA) in controlling blood loss during spine surgery remains unclear. With the publication of new randomized controlled trials (RCTs), we conducted a meta-analysis to determine the safety and efficacy of TXA in spine surgery. PubMed, Embase, Web of Science, and Cochrane databases were searched for relevant studies through 2022. Only RCTs were eligible for this study. The extracted data were analyzed using RevMan 5.3 software for meta-analysis. Twenty RCTs including 1497 patients undergoing spine surgery were included in this systematic evaluation. Compared with the control group, TXA significantly reduced total blood loss (mean difference [MD] = – 218.96, 95% confidence interval [CI] = – 309.77 to – 128.14, P < 0.00001), perioperative blood loss (MD = – 90.54, 95% CI = – 139.33 to – 41.75, P = 0.0003), postoperative drainage (MD = – 102.60, 95% CI = – 139.51 to – 65.70, P < 0.00001)，reduced hospital stay (MD = – 1.42, 95% CI = – 2.71 to – 0.14, P = 0.03), reduced total blood transfusion volume (MD = – 551.06, 95% CI = – 755.90 to – 346.22, P < 0.00001), and international normalized ratio (MD = −0.03, 95% CI = −0.04 to −0.02, P < 0.00001). Based on the meta-analysis of 20 RCTs, we demonstrated that TXA reduces blood loss in open spine surgery, decreases transfusion rates, and shortens hospital stays. The TXA administration during the perioperative period does not increase the incidence of postoperative complications. [ABSTRACT FROM AUTHOR]

Background: Randomized controlled trials (RCTs) of vitamin D (VitD) supplementation for depression have yielded inconsistent results. We conducted the first RCT of VitD supplementation with multipoint serum 25(OH)D assessments in major depressive disorder (MDD) patients with concurrent severe VitD deficiency.Methods: We randomized antidepressant-free depressed adults with mean baseline 25(OH)D of 11.5 ng/ml to VitD (60,000 IU every 5 days; n = 31) or placebo (n = 28) for 12 weeks. All patients also received escitalopram (10-20 mg/day). Patients were rated at baseline and at the end of weeks 4, 8, and 12. Serum 25(OH)D was estimated at baseline, week 8, and week 12.Results: In an intent-to-treat analysis, mean Hamilton Depression Scale scores dropped from 25.7 to 5.7 and from 25.8 to 5.0 in VitD and placebo groups, respectively (primary outcome; P = 0.92). VitD and placebo groups did not differ on other objective and subjective ratings of depression, or on global ratings. Similar findings characterized completer analyses. No significant correlations were observed between 25(OH)D levels and depression ratings across the course of the study. Importantly, endpoint escitalopram doses were 4 mg/day higher in placebo than in VitD patients, and 4 mg/day higher in VitD deficient than in VitD sufficient patients.Limitations: A ceiling effect with escitalopram may have prevented the discovery of benefits with VitD supplementation.Conclusions: VitD supplementation does not improve antidepressant outcomes with flexibly dosed escitalopram. VitD deficient depressed patients may require higher antidepressant doses to experience benefits similar to those whose deficiency is corrected by VitD supplementation. [ABSTRACT FROM AUTHOR]

The COVID-19 pandemic increases healthcare worker (HCW) absenteeism. The bacillus Calmette-Guérin (BCG) vaccine may provide non-specific protection against respiratory infections through enhancement of trained immunity. We investigated the impact of BCG vaccination on HCW absenteeism during the COVID-19 pandemic. HCWs exposed to COVID-19 patients in nine Dutch hospitals were randomized to BCG vaccine or placebo in a 1:1 ratio, and followed for one year using a mobile phone application. The primary endpoint was the self-reported number of days of unplanned absenteeism for any reason. Secondary endpoints included documented COVID-19, acute respiratory symptoms or fever. This was an investigator-funded study, registered at ClinicalTrials.gov (NCT03987919). In March/April 2020, 1511 HCWs were enrolled. The median duration of follow-up was 357 person-days (interquartile range [IQR], 351 to 361). Unplanned absenteeism for any reason was observed in 2.8% of planned working days in the BCG group and 2.7% in the placebo group (adjusted relative risk 0.94; 95% credible interval, 0.78–1.15). Cumulative incidences of documented COVID-19 were 14.2% in the BCG and 15.2% in the placebo group (adjusted hazard ratio (aHR) 0.94; 95% confidence interval (CI), 0.72–1.24). First episodes of self-reported acute respiratory symptoms or fever occurred in 490 (66.2%) and 443 (60.2%) participants, respectively (aHR: 1.13; 95% CI, 0.99–1.28). Thirty-one serious adverse events were reported (13 after BCG, 18 after placebo), none considered related to study medication. During the COVID-19 pandemic, BCG-vaccination of HCW exposed to COVID-19 patients did not reduce unplanned absenteeism nor documented COVID-19. [ABSTRACT FROM AUTHOR]

Objectives: To evaluate the effectiveness of a question prompt list (QPL) in decision self-efficacy, decision-making participation, patient-physician communication, decisional conflict or regret, and health status in patients with breast cancer.Methods: A total of 240 patients with breast cancer were randomly assigned to a QPL group or control group (n = 120 each). The intervention and control groups received an additional educational QPL booklet and routine care, respectively.Results: The intervention group exhibited significant improvements in decision self-efficacy, perceived patient-physician interactions, and patient-physician communication compared with the control group. Multilevel modeling analyses revealed significant group-time interaction effects on decision self-efficacy (β = 9.99, P < 0.01), perceived patient-physician interactions (β = 8.10, P < 0.01), patient-physician communication (β = 5.02, P < 0.01), and anxiety status (β = -3.78, P < 0.05). The QPL intervention exerted more favorable effects than routine care, with repeated measurements of the same patients and the data of patients under the care of the same surgeons accounted for.Conclusions: The QPL intervention exerted multidimensional effects on decision-making outcomes among patients with breast cancer.Practical Implications: Clinicians can integrate a QPL into routine care for patients with breast cancer. [ABSTRACT FROM AUTHOR]