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Background Schizophrenia and bipolar disorder are severe mental illnesses which are highly prevalent worldwide. Risperidone and Paliperidone are treatments for either illnesses, but their efficacy compared to other antipsychotics and growing reports of hormonal imbalances continue to raise concerns. As existing evidence on both antipsychotics are solely based on aggregate data, we aimed to assess the benefits and harms of Risperidone and Paliperidone in the treatment of patients with schizophrenia or bipolar disorder, using individual participant data (IPD), clinical study reports (CSRs) and publicly available sources (journal publications and trial registries). Methods We searched MEDLINE, Central, EMBASE and PsycINFO until December 2020 for randomised placebo-controlled trials of Risperidone, Paliperidone or Paliperidone palmitate in patients with schizophrenia or bipolar disorder. We obtained IPD and CSRs from the Yale University Open Data Access project. The primary outcome Positive and Negative Syndrome Scale (PANSS) score was analysed using one-stage IPD meta-analysis. Random-effect meta-analysis of harm outcomes involved methods for coping with rare events. Effect-sizes were compared across all available data sources using the ratio of means or relative risk. We registered our review on PROSPERO, CRD42019140556. Results Of the 35 studies, IPD meta-analysis involving 22 (63%) studies showed a significant clinical reduction in the PANSS in patients receiving Risperidone (mean difference − 5.83, 95% CI − 10.79 to − 0.87, I2 = 8.5%, n = 4 studies, 1131 participants), Paliperidone (− 6.01, 95% CI − 8.7 to − 3.32, I2 = 4.3%, n = 13, 3821) and Paliperidone palmitate (− 7.89, 95% CI − 12.1 to − 3.69, I2 = 2.9%, n = 5, 2209). CSRs reported nearly two times more adverse events (4434 vs. 2296 publication, relative difference (RD) = 1.93, 95% CI 1.86 to 2.00) and almost 8 times more serious adverse events (650 vs. 82; RD = 7.93, 95% CI 6.32 to 9.95) than the journal publications. Meta-analyses of individual harms from CSRs revealed a significant increased risk among several outcomes including extrapyramidal disorder, tardive dyskinesia and increased weight. But the ratio of relative risk between the different data sources was not significant. Three treatment-related gynecomastia events occurred, and these were considered mild to moderate in severity. Conclusion IPD meta-analysis conclude that Risperidone and Paliperidone antipsychotics had a small beneficial effect on reducing PANSS score over 9 weeks, which is more conservative than estimates from reviews based on journal publications. CSRs also contained significantly more data on harms that were unavailable in journal publications or trial registries. Sharing of IPD and CSRs are necessary when performing meta-analysis on the efficacy and safety of antipsychotics.

Background: longitudinal studies examining mental health trajectories in refugees and asylum seekers are scarce. Objectives: to investigate trajectories of psychological symptoms and wellbeing in refugees and asylum seekers, and identify factors associated with these trajectories. Method: 912 asylum seekers and refugees from the control arm of three trials in Europe (n = 229), Turkey (n = 320), and Uganda (n = 363) were included. We described trajectories of psychological symptoms and wellbeing, and used trauma exposure, age, marital status, education, and individual trial as predictors. Then, we assessed the bidirectional interactions between wellbeing and psychological symptoms, and the effect of each predictor on each outcome controlling for baseline values. Results: symptom improvement was identified in all trials, and for wellbeing in 64.7% of participants in Europe and Turkey, versus 31.5% in Uganda. In Europe and Turkey domestic violence predicted increased symptoms at post-intervention (ss = 1.36, 95% CI 0.17-2.56), whilst murder of family members at 6-month follow-up (ss = 1.23, 95% CI 0.27-2.19). Lower wellbeing was predicted by murder of family member (ss = -1.69, 95% CI -3.06 to -0.32), having been kidnapped (ss = -1.67, 95% CI -3.19 to -0.15), close to death (ss = -1.38, 95% CI -2.70 to -0.06), and being in the host country >= 2 years (ss = -1.60, 95% CI -3.05 to -0.14). In Uganda at post-intervention, having been kidnapped predicted increased symptoms (ss = 2.11, 95% CI 0.58-3.65), and lack of shelter (ss = -2.51, 95% CI -4.44 to -0.58) and domestic violence predicted lower wellbeing (ss = -1.36, 95% CI -2.67 to -0.05). Conclusion: many participants adapt to adversity, but contextual factors play a critical role in determining mental health trajectories. / Antecedentes: estudios longitudinales que examinan las trayectorias de la salud mental en losrefugiados y solicitantes de asilo son escasos. Objetivos: investigar las trayectorias de los síntomas psicológicos y el bienestar en refugiadosy solicitantes de asilo, e identificar factores asociados a estas trayectorias.Métodos:Se incluyeron 912 solicitantes de asilos y refugiados del brazo control de tresensayos clínicos en Europa (n= 229), Turquía (n= 320) y Uganda (n= 363). Describimos las trayectorias psicológicas de los síntomas y el bienestar, y utilizamos la exposición traumática, laedad, el estado marital, la educación y el juicio individual como predictores. Después,evaluamos las interacciones bidireccionales entre el bienestar y los síntomas psicológicos, yel efecto de cada uno de los predictores en cada resultado controlando por los valores iniciales.Resultados: se identificó una mejoría en los síntomas en todos los ensayos, y del bienestar en el64.7% de los participantes en Europa y Turquía, versus el 31.5% en Uganda. En Europa y en Turquía,la violencia doméstica predijo el incremento de síntomas de después de la intervención (ß= 1.36,95% CI 0.17 a 2.56), mientras que el homicidio de algún miembro familiar a los 6 meses deseguimiento (ß= 1.23, 95% CI 0.27 a 2.19). Un menor bienestar fue predicho por el homicidio dealgún miembro de la familia (ß=−1.69, 95% CI−3.06 a−0.32), haber sido secuestrado (ß=−1.67, 95% CI−3.19 a−0.15), haber estado próximo a la muerte (ß=−1.38, 95% CI−2.70 a−0.06), y estar en el país de acogida≥2años(ß=−1.60, 95% CI−3.05 a−0.14). En Uganda,después de la intervención, haber sido secuestrado predijo un aumento de los síntomas(ß=2.11, 95% CI 0.58 a 3.65), y la falta de refugio (ß=−2.51, 95% CI−4.44 a−0.58) y laviolencia doméstica predijo un menor bienestar (ß=−1.36, 95% CI−2.67 a−0.05).Conclusión: muchos participantes se adaptan a la adversidad, pero los factores contextualesjuegan un papel crítico en determinar las trayectorias de la salud mental., European Union (EU); Horizon 2020; European Commission (EC); RE-DEFINE: Refugee Emergency DEFining and Implementing Novel Evidence-based psycho-social Interventions

To assess whether CC is more effective at reducing suicidal ideation in people with depression compared with usual care, and whether study and patient factors moderate treatment effects. We searched Medline, Embase, PubMed, PsycINFO, CINAHL, CENTRAL from inception to March 2020 for Randomised Controlled Trials (RCTs) that compared the effectiveness of CC with usual care in depressed adults, and reported changes in suicidal ideation at 4 to 6 months post-randomisation. Mixed-effects models accounted for clustering of participants within trials and heterogeneity across trials. This study is registered with PROSPERO, CRD42020201747. We extracted data from 28 RCTs (11,165 patients) of 83 eligible studies. We observed a small significant clinical improvement of CC on suicidal ideation, compared with usual care (SMD, -0.11 [95%CI, -0.15 to -0.08]; I , 0·47% [95%CI 0.04% to 4.90%]). CC interventions with a recognised psychological treatment were associated with small reductions in suicidal ideation (SMD, -0.15 [95%CI -0.19 to -0.11]). CC was more effective for reducing suicidal ideation among patients aged over 65 years (SMD, - 0.18 [95%CI -0.25 to -0.11]). Primary care based CC with an embedded psychological intervention is the most effective CC framework for reducing suicidal ideation and older patients may benefit the most. [Abstract copyright: Copyright © 2021 The Authors. Published by Elsevier Inc. All rights reserved.]

Background Empirical evidence is uncertain regarding the value of nonblanchable erythema in predicting the incidence of stage 2 (or more severe) pressure ulcers. Objectives To investigate whether nonblanchable erythema is an independent prognostic factor for pressure ulcer incidence using individual patient data. Methods We performed an electronic database search in February 2017 to identify longitudinal studies that considered nonblanchable erythema for predicting pressure ulcer risk in any population. We collected individual participant data for the included studies, and assessed the risk of bias of these studies using the Quality In Prognosis Studies tool. We analysed individual participant data in Stata using mixed-effects logistic regression to investigate the association of interest. The certainty of evidence from individual participant data analysis was assessed using the Grades of Recommendation Assessment, Development and Evaluation. The study was registered with PROSPERO (CRD42017081151). Results From the 13 included studies (total 68 077 participants) we had access to individual participant data from four (n = 3223), and 11·9% of participants (383 of 3223) developed new pressure ulcers of stage 2 or above within 28 days. Mixed-effects logistic regression showed that participants with nonblanchable erythema had higher odds of developing new pressure ulcers of stage 2 or above within 28 days of follow-up than those without nonblanchable erythema (multivariable association: n = 2684; odds ratio 2·72, 95% confidence interval 2·02-3·69; τ2 = 0; moderate-certainty evidence). Conclusions This first prognostic factor review with individual-level data analysis in patients with pressure ulcers suggests that people with nonblanchable erythema are more likely to develop new pressure ulcers of stage 2 or above within 28 days than people without nonblanchable erythema. It is important to identify nonblanchable erythema in practice and to intervene appropriately to prevent pressure ulceration. What's already known about this topic? Pressure ulcer reduction is a high priority for healthcare systems. Regularly inspecting skin to identify skin abnormalities is one key practice for preventing ulceration. Nonblanchable erythema - discoloration of the skin that does not turn white when pressed - is one clinically important skin abnormality. Empirical evidence synthesized using conventional meta-analysis is uncertain regarding the value of nonblanchable erythema for predicting open pressure ulcer incidence; this is partly because the conventional technique has weakness in terms of pooling prognostic effects of different multivariable analyses across studies. What does this study add? This prognostic factor review used individual-level data analysis to overcome the limitations of the conventional meta-analysis technique. For the first time there is confirmatory and moderate-certainty evidence on the association of nonblanchable erythema with pressure ulcer incidence. People with nonblanchable erythema are more likely to develop new pressure ulcers of stage 2 or more severe within 28 days than people without nonblanchable erythema, regardless of their age, baseline pressure ulcer risk or received support surfaces.

Background Epidemiologic studies often struggle to adequately represent populations and outcomes of interest. Differences in methodology, data analysis and research questions often mean that reviews and synthesis of the existing literature have significant limitations. The current paper details our experiences in combining individual participant data from two existing cohort studies to address questions about the influence of social factors on health outcomes within a representative sample of urban to remote areas of Australia. The eXtending Treatments, Education and Networks in Depression study involved pooling individual participant data from the Australian Rural Mental Health Study (T0 N = 2639) and the Hunter Community Study (T0 N = 3253) as well as conducting a common three-year follow-up phase (T1 N = 3513). Pooling these data extended the capacity of these studies by: enabling research questions of common interest to be addressed; facilitating the harmonization of baseline measures; permitting investigation of a range of psychosocial, physical and contextual factors over time; and contributing to the development and implementation of targeted interventions for persons experiencing depression and alcohol issues. Discussion The current paper describes the rationale, challenges encountered, and solutions devised by a project aiming to maximise the benefits derived from existing cohort studies. We also highlight opportunities for such individual participant data analyses to assess common assumptions in research synthesis, such as measurement invariance, and opportunities for extending ongoing cohorts by conducting a common follow-up phase. Summary Pooling individual participant data can be a worthwhile venture, particularly where adequate representation is beyond the scope of existing research, where the effects of interest are small though important, where events are of relatively low frequency or rarely observed, and where issues are of immediate regional or national interest. Benefits such as these can enhance the utility of existing projects and strengthen requests for further research funding.