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A Brain-computer interface (BCI) system establishes a novel communication channel between the human brain and a computer. Most event related potential-based BCI applications make use of decoding models, which requires training. This training process is often time-consuming and inconvenient for new users. In recent years, deep learning models, especially participant-independent models, have garnered significant attention in the domain of ERP classification. However, individual differences in EEG signals hamper model generalization, as the ERP component and other aspects of the EEG signal vary across participants, even when they are exposed to the same stimuli. This paper proposes a novel One-source domain transfer learning method based Attention Domain Adversarial Neural Network (OADANN) to mitigate data distribution discrepancies for cross-participant classification tasks. We train and validate our proposed model on both a publicly available OpenBMI dataset and a Self-collected dataset, employing a leave one participant out cross validation scheme. Experimental results demonstrate that the proposed OADANN method achieves the highest and most robust classification performance and exhibits significant improvements when compared to baseline methods (CNN, EEGNet, ShallowNet, DeepCovNet) and domain generalization methods (ERM, Mixup, and Groupdro). These findings underscore the efficacy of our proposed method.

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BACKGROUND: There is insufficient evidence to provide recommendations for leisure-time physical activity among workers across various occupational physical activity levels. This study aimed to assess the association of leisure-time physical activity with cardiovascular and all-cause mortality across occupational physical activity levels. METHODS: This study utilized individual participant data from 21 cohort studies, comprising both published and unpublished data. Eligibility criteria included individual-level data on leisure-time and occupational physical activity (categorized as sedentary, low, moderate, and high) along with data on all-cause and/or cardiovascular mortality. A 2-stage individual participant data meta-analysis was conducted, with separate analysis of each study using Cox proportional hazards models (Stage 1). These results were combined using random-effects models (Stage 2). RESULTS: Higher leisure-time physical activity levels were associated with lower all-cause and cardiovascular mortality risk across most occupational physical activity levels, for both males and females. Among males with sedentary work, high compared to sedentary leisure-time physical activity was associated with lower all-cause (hazard ratios (HR) = 0.77, 95% Confidence interval(95%CI): 0.70-0.85) and cardiovascular mortality (HR = 0.76, 95%CI: 0.66-0.87) risk. Among males with high levels of occupational physical activity, high compared to sedentary leisure-time physical activity was associated with lower all-cause (HR = 0.84, 95%CI: 0.74-0.97) and cardiovascular mortality (HR = 0.79, 95%CI: 0.60-1.04) risk, while HRs for low and moderate levels of leisure-time physical activity ranged between 0.87 and 0.97 and were not statistically significant. Among females, most effects were similar but more imprecise, especially in the higher occupational physical activity levels. CONCLUSION: Higher levels of leisure-time physical activity were generally associated with lower mortality risks. However, results for workers with moderate and high occupational physical activity levels, especially women, were more imprecise. Our findings suggests that workers may benefit from engaging in high levels of leisure-time physical activity, irrespective of their level of occupational physical activity.

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Background: Approximately 2% of the global population has survived tuberculosis (TB). Increasing evidence indicates that a significant proportion of pulmonary TB survivors develop TB-associated respiratory disability, commonly referred to as post-TB lung disease (PLTD) and marked by impaired respiratory function, persistent symptoms, and activity limitations. However, the prevalence, risk factors, and progression of TB-associated respiratory disability throughout the life course are not well understood. To address these gaps, we will undertake a systematic review and individual participant-level data meta-analysis (IPD-MA) focusing on TB-associated respiratory disability in children, adolescents, and adults successfully treated for pulmonary TB. Methods and analysis: We will systematically search MEDLINE, Embase, CENTRAL, Global Index Medicus, and medRxiv for original studies investigating TB-associated respiratory disability in people of all ages who have completed treatment for microbiologically confirmed or clinically diagnosed pulmonary TB. Authors of eligible studies will be invited to contribute de-identified data and form a collaborative group. Primary outcomes will be (1) abnormal lung function based on spirometry parameters and (2) chronic respiratory symptoms. We will estimate the overall and subgroup-specific prevalence of each outcome through IPD meta-analysis. Next, we will develop clinical prediction tools assessing the risk of future TB-associated respiratory disability at (i) the start of TB treatment and (ii) end of TB treatment for those without existing signs of disability. Finally, we will use stepwise hierarchical modelling to identify epidemiological determinants of respiratory disability. Ethics and dissemination: This study has been approved by the ethics review boards at the Rhode Island Hospital (2138217-2) and the Research Institute of the McGill University Health Centre (2024-10345). Individual study authors will be required to obtain institutional approval prior to sharing data. Results will be disseminated through open-access, peer-reviewed publications and conference presentations. Prospero registration number: CRD42024529906.

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Background: Low levels of testosterone cause male hypogonadism, which is associated with sexual dysfunction, tiredness and reduced muscle strength and quality of life. Testosterone replacement therapy is commonly used for ameliorating symptoms of male hypogonadism, but there is uncertainty about the magnitude of its effects and its cardiovascular and cerebrovascular safety. Aims of the research: The primary aim was to evaluate the safety of testosterone replacement therapy. We also assessed the clinical and cost-effectiveness of testosterone replacement therapy for men with male hypogonadism, and the existing qualitative evidence on men's experience and acceptability of testosterone replacement therapy. Design: Evidence synthesis and individual participant data meta-analysis of effectiveness and safety, qualitative evidence synthesis and model-based cost-utility analysis. Data sources: Major electronic databases were searched from 1992 to February 2021 and were restricted to English-language publications. Methods: We conducted a systematic review with meta-analysis of individual participant data according to current methodological standards. Evidence was considered from placebo-controlled randomised controlled trials assessing the effects of any formulation of testosterone replacement therapy in men with male hypogonadism. Primary outcomes were mortality and cardiovascular and cerebrovascular events. Data were extracted by one reviewer and cross-checked by a second reviewer. The risk of bias was assessed using the Cochrane Risk of Bias tool. We performed one-stage meta-analyses using the acquired individual participant data and two-stage meta-analyses to integrate the individual participant data with data extracted from eligible studies that did not provide individual participant data. A decision-analytic Markov model was developed to evaluate the cost per quality-adjusted life-years of the use of testosterone replacement therapy in cohorts of patients of different starting ages. Results: We identified 35 trials (5601 randomised participants). Of these, 17 trials (3431 participants) provided individual participant data. There were too few deaths to assess mortality. There was no difference between the testosterone replacement therapy group (120/1601, 7.5%) and placebo group (110/1519, 7.2%) in the incidence of cardiovascular and/or cerebrovascular events (13 studies, odds ratio 1.07, 95% confidence interval 0.81 to 1.42; p = 0.62). Testosterone replacement therapy improved quality of life and sexual function in almost all patient subgroups. In the testosterone replacement therapy group, serum testosterone was higher while serum cholesterol, triglycerides, haemoglobin and haematocrit were all lower. We identified several themes from five qualitative studies showing how symptoms of low testosterone affect men's lives and their experience of treatment. The cost-effectiveness of testosterone replacement therapy was dependent on whether uncertain effects on all-cause mortality were included in the model, and on the approach used to estimate the health state utility increment associated with testosterone replacement therapy, which might have been driven by improvements in symptoms such as sexual dysfunction and low mood. Limitations: A meaningful evaluation of mortality was hampered by the limited number of defined events. Definition and reporting of cardiovascular and cerebrovascular events and methods for testosterone measurement varied across trials. Conclusions: Our findings do not support a relationship between testosterone replacement therapy and cardiovascular/cerebrovascular events in the short-to-medium term. Testosterone replacement therapy improves sexual function and quality of life without adverse effects on blood pressure, serum lipids or glycaemic markers. Future work: Rigorous long-term evidence assessing the safety of testosterone replacement therapy and subgroups most benefiting from treatment is needed. Study registration: The study is registered as PROSPERO CRD42018111005. Funding: This award was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme (NIHR award ref: 17/68/01) and is published in full in Health Technology Assessment; Vol. 28, No. 43. See the NIHR Funding and Awards website for further award information.

Testosterone is a hormone which is vital for sexual activity, bone growth and muscle development in men. Men with low testosterone levels may experience problems with erections and may suffer from brittle bones (osteoporosis), weakness, feeling down (low mood) and tiredness. The manifestations of low testosterone can be treated with testosterone replacement therapy. However, there is current uncertainty about the positive effects of testosterone replacement therapy and its safety. We brought together results from all available medical studies that looked at the use of testosterone replacement therapy in men with low testosterone and contacted the doctors who led these studies to gather further information on their participants. We found 35 studies (5601 participants) conducted in different countries, 17 of which provided additional information on their participants. We did not find any evidence to show that testosterone replacement therapy increases the risk of heart problems, or any evidence to show that some men who take testosterone replacement therapy benefit more than others. Men with low testosterone reported having low mood, poor concentration and lack of energy; however, medical studies often failed to prove that these manifestations improved with testosterone replacement therapy. Most medical studies were conducted among white men in North America using questionnaires designed specifically for them; therefore, the results may not reflect the experiences of men in other countries and from more diverse ethnic backgrounds. There is too much uncertainty about the benefits of testosterone replacement therapy to accurately estimate its value for money for the NHS. We think our findings offer some reassurance to doctors and patients that testosterone replacement therapy does not increase the risk of heart problems. New studies are needed to find out whether some groups of men (such as older or younger men) are more likely to benefit from testosterone replacement therapy more than others. It is also important to develop tools which better reflect the experience of men from a diverse range of social and ethnic backgrounds. To inform men with low testosterone about our findings, we are creating a website with dedicated YouTube video clips.

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Individual participant data (IPD) meta-analysis projects obtain, harmonise, and synthesise original data from multiple studies. Many IPD meta-analyses of randomised trials are initiated to identify treatment effect modifiers at the individual level, thus requiring statistical modelling of interactions between treatment effect and participant-level covariates. Using a two-stage approach, the interaction is estimated in each trial separately and combined in a meta-analysis. In practice, two complications often arise with continuous outcomes: examining non-linear relationships for continuous covariates and dealing with multiple time-points. We propose a two-stage multivariate IPD meta-analysis approach that summarises non-linear treatment-covariate interaction functions at multiple time-points for continuous outcomes. A set-up phase is required to identify a small set of time-points; relevant knot positions for a spline function, at identical locations in each trial; and a common reference group for each covariate. Crucially, the multivariate approach can include participants or trials with missing outcomes at some time-points. In the first stage, restricted cubic spline functions are fitted and their interaction with each discrete time-point is estimated in each trial separately. In the second stage, the parameter estimates defining these multiple interaction functions are jointly synthesised in a multivariate random-effects meta-analysis model accounting for within-trial and across-trial correlation. These meta-analysis estimates define the summary non-linear interactions at each time-point, which can be displayed graphically alongside confidence intervals. The approach is illustrated using an IPD meta-analysis examining effect modifiers for exercise interventions in osteoarthritis, which shows evidence of non-linear relationships and small gains in precision by analysing all time-points jointly.

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Background: Oxygen therapy is a cornerstone treatment of critically ill patients in the intensive care unit (ICU). Whether lower oxygenation therapy brings superior survival outcomes to higher oxygenation therapy is unknown. Methods: We will search electronic databases: PubMed, Embase, Web of Science, the Cochrane Central Register of Controlled Trials (CENTRAL), International Clinical Trials Registry Platform (ICTRP), and ClinicalTrials.gov from inception to 1 January 2024. Two authors will independently screen for all eligible clinical studies. Emails will be sent for individual participant data. The statistical analyses will be conducted using STATA 15.0 software. Results: We will evaluate the efficacy of lower oxygenation therapy compared with higher oxygenation therapy based on individual participant data. Conclusion: This study will offer clinical evidence for oxygen therapy in ICU patients.

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Background: Worldwide, nearly 830 women die from complications of pregnancy and childbirth daily. Ninety-nine per cent of these maternal deaths take place in low and middle-income countries. Basic Emergency Obstetric Care (BEmONC) is one method of reducing maternal mortality related to pregnancy and childbirth complications. However, the status of its implementation fidelity has not been investigated. Therefore, this study sought to evaluate the implementation fidelity of BEmONC services in Beyeda District, Northwest Ethiopia. Evaluation methods: A single case study design with mixed method was employed from June 01 to July 30, 2022. 415 client exit interviews, 14 key informants' interviews and 423 retrospective document reviews were conducted. Adherence, participant responsiveness and quality of delivery dimensions from Carroll's conceptual framework, with a total of 21 indicators were used in this evaluation. The overall implementation fidelity status of BEmONC service was judged based on the pre-seated judgmental criteria as; low, medium, and high fidelity. Results: The overall degree of implementation fidelity of the BEmONC services was 74.5%. Moreover, the implementation fidelity status of adherence, quality of delivery, and participant responsiveness dimensions were 74.7%, 77.2%, and 71.5% respectively. Uterotonic drugs were not administered as per the recommended protocol. Participants' engagement towards the neonatal resuscitation service delivery was inadequate. Likewise, healthcare providers' respect for the clients was not sufficient. Furthermore, women aged >30 years, being government employed and ANC visits four and above were variables positively associated with the quality of delivery of BEmONC services. Conclusion: The overall implementation fidelity of the BEmONC services was judged as implemented in medium fidelity. Moreover, the adherence, participant responsiveness and quality of delivery dimensions were found to be implemented in medium fidelity. Therefore, public health sectors at all levels should strive to enhance the implementation fidelity of BEmONC services. Moreover, healthcare providers should adhere to the BEmONC implementation protocol guideline during service delivery. Healthcare managers should facilitate a continuous awareness creation for mothers regarding the merit of neonatal resuscitation for neonatal complications. Furthermore, healthcare providers should give due respect to mothers while delivering the services.

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Research on brain function in natural environments has become a new interest in cognitive science. In this study, we aim to advance mobile electroencephalography (EEG) participant and device mobility. We investigated the feasibility of measuring human brain activity using mobile EEG during a full-body motion task as swimming, by the example of cognitive-motor interference (CMI). Eleven participants were given an auditory oddball task while sitting and swimming, with mobile EEG recording ongoing brain activity. Measures of interest were event-related potentials (ERPs) elicited by experimental stimuli. While the auditory N100 was measured to verify signal quality, the P300 to task-relevant stimuli served as a marker of CMI effects. Analyzes were first performed within subjects, while binomial tests assessed the proportion of significant effects. Event-related changes in the time-frequency domain around turns during swimming were analyzed in an exploratory fashion. The successful recording of the N100 in all conditions shows that the setup was functional throughout the experiment. Regarding CMI, we did not find reliable changes in P300 amplitude in different motor settings in all subjects. However, we found plausible modulations in the alpha/mu and beta bands before and after turns. This study shows that it is generally feasible to measure mobile EEG in the time and time-frequency domain in an aquatic environment while subjects are freely moving. We see promising potential in the use of mobile EEG in extreme settings, advancing toward the application of mobile EEG in more real-life situations.

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OBJECTIVE: Demonstrate how patient-level traumatic brain injury (TBI) data from studies in the Federal Interagency Traumatic Brain Injury Research (FITBIR) Informatics System can be harmonized and pooled to examine relationships between TBI and cognitive functioning. METHOD: We harmonized and pooled data across studies and analyzed rates of probable cognitive functioning deficits by TBI history and severity. RESULTS: Four publicly available FITBIR studies with 3,445 participants included data on cognitive dysfunction, though only one included comparison groups (mild TBI vs. no history of TBI) and could be used in the final comparative analyses. Of the 1,539 participants, 82% had a history of mild TBI and 67% had data suggesting the presence of cognitive dysfunction. Participants with a history of mild TBI were mostly male (87%), 25-39 years old (53%), and Non-Hispanic White (60%). Conclusions: One publicly available FITBIR study reported cognitive dysfunction data as of January 2021, though findings were similar to prior research and supported an association between mild TBI and cognitive dysfunction. This proof-of-concept study shared newly developed methods including harmonization, analysis syntax, and meta-data via the FITBIR website to encourage dissemination of these TBI data resources in line with FAIR data goals.

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Individual participant data (IPD) meta-analysis provides important opportunities to study interaction and effect modification for which individual studies often lack power. While previous meta-analyses have commonly focused on multiplicative interaction, additive interaction holds greater relevance for public health and may in certain contexts better reflect biological interaction. Methodological literature on interaction in IPD meta-analysis does not cover additive interaction for models including binary or time-to-event outcomes. We aimed to describe how the Relative Excess Risk due to Interaction (RERI) and other measures of additive interaction or effect modification can be validly estimated within two-stage IPD meta-analysis. First, we explain why direct pooling of study-level RERI estimates may lead to invalid results. Next, we propose a three-step procedure to estimate additive interaction: 1) estimate effects of both exposures and their product term on the outcome within each individual study; 2) pool study-specific estimates using multivariate meta-analysis; 3) estimate an overall RERI and 95% confidence interval based on the pooled effect estimates. We illustrate this procedure by investigating interaction between depression and smoking and risk of smoking-related cancers using data from the PSYchosocial factors and Cancer (PSY-CA) consortium. We discuss implications of this procedure, including the application in meta-analysis based on published data.

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INTRODUCTION: We evaluated preliminary feasibility of a digital, culturally-informed approach to recruit and screen participants for the Alzheimer's Disease Neuroimaging Initiative (ADNI4). METHODS: Participants were recruited using digital advertising and completed digital surveys (e.g., demographics, medical exclusion criteria, 12-item Everyday Cognition Scale [ECog-12]), Novoic Storyteller speech-based cognitive test). Completion rates and assessment performance were compared between underrepresented populations (URPs: individuals from ethnoculturally minoritized or low education backgrounds) and non-URPs. RESULTS: Of 3099 participants who provided contact information, 654 enrolled in the cohort, and 595 completed at least one assessment. Two hundred forty-seven participants were from URPs. Of those enrolled, 465 met ADNI4 inclusion criteria and 237 evidenced possible cognitive impairment from ECog-12 or Storyteller performance. URPs had lower ECog and Storyteller completion rates. Scores varied by ethnocultural group and educational level. DISCUSSION: Preliminary results demonstrate digital recruitment and screening assessment of an older diverse cohort, including those with possible cognitive impairment, are feasible. Improving engagement and achieving educational diversity are key challenges. HIGHLIGHTS: A total of 654 participants enrolled in a digital cohort to facilitate ADNI4 recruitment. Culturally-informed digital ads aided enrollment of underrepresented populations. From those enrolled, 42% were from underrepresented ethnocultural and educational groups. Digital screening tools indicate > 50% of participants likely cognitively impaired. Completion rates and assessment performance vary by ethnocultural group and education.

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BACKGROUND: Artificial intelligence (AI) is widely used in various medical fields, including diagnostic radiology as a tool for greater efficiency, precision, and accuracy. The integration of AI as a radiological diagnostic tool has the potential to mitigate delays in diagnosis, which could, in turn, impact patients' prognosis and treatment outcomes. The literature shows conflicting results regarding patients' attitudes to AI as a diagnostic tool. To the best of our knowledge, no similar study has been conducted in Saudi Arabia. OBJECTIVE: The objectives of this study are to examine patients' attitudes toward the use of AI as a tool in diagnostic radiology at King Khalid University Hospital, Saudi Arabia. Additionally, we sought to explore potential associations between patients' attitudes and various sociodemographic factors. METHODS: This descriptive-analytical cross-sectional study was conducted in a tertiary care hospital. Data were collected from patients scheduled for radiological imaging through a validated self-administered questionnaire. The main outcome was to measure patients' attitudes to the use of AI in radiology by calculating mean scores of 5 factors, distrust and accountability (factor 1), procedural knowledge (factor 2), personal interaction and communication (factor 3), efficiency (factor 4), and methods of providing information to patients (factor 5). Data were analyzed using the student t test, one-way analysis of variance followed by post hoc and multivariable analysis. RESULTS: A total of 382 participants (n=273, 71.5% women and n=109, 28.5% men) completed the surveys and were included in the analysis. The mean age of the respondents was 39.51 (SD 13.26) years. Participants favored physicians over AI for procedural knowledge, personal interaction, and being informed. However, the participants demonstrated a neutral attitude for distrust and accountability and for efficiency. Marital status was found to be associated with distrust and accountability, procedural knowledge, and personal interaction. Associations were also found between self-reported health status and being informed and between the field of specialization and distrust and accountability. CONCLUSIONS: Patients were keen to understand the work of AI in radiology but favored personal interaction with a radiologist. Patients were impartial toward AI replacing radiologists and the efficiency of AI, which should be a consideration in future policy development and integration. Future research involving multicenter studies in different regions of Saudi Arabia is required.

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Research participants report interest in receiving genetic research results. How best to return results remains unclear. In this randomized pilot study, we sought to assess the feasibility of returning actionable research results through a two-step process including a patient-centered digital intervention as compared with a genetic counselor (GC) in the Penn Medicine biobank. In Step 1, participants with an actionable result and procedural controls (no actionable result) were invited to digital pre-disclosure education and provided options for opting out of results. In Step 2, those with actionable results who had not opted out were randomized to receive results via a digital disclosure intervention or with a GC. Five participants (2%) opted out of results after Step 1. After both steps, 52 of 113 (46.0%) eligible cases received results, 5 (4.4%) actively declined results, 34 (30.1%) passively declined, and 22 (19.5%) could not be reached. Receiving results was associated with younger age (p < 0.001), completing pre-disclosure education (p < 0.001), and being in the GC arm (p = 0.06). Being older, female, and of Black race were associated with being unable to reach. Older age and Black race were associated with passively declining. Forty-seven percent of those who received results did not have personal or family history to suggest the mutation, and 55.1% completed clinical confirmation testing. The use of digital tools may be acceptable to participants and could reduce costs of returning results. Low uptake, disparities in uptake, and barriers to confirmation testing will be important to address to realize the benefit of returning actionable research results.

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Increasing concerns about the trustworthiness of research have prompted calls to scrutinise studies' Individual Participant Data (IPD), but guidance on how to do this was lacking. To address this, we developed the IPD Integrity Tool to screen randomised controlled trials (RCTs) for integrity issues. Development of the tool involved a literature review, consultation with an expert advisory group, piloting on two IPD meta-analyses (including 73 trials with IPD), preliminary validation on 13 datasets with and without known integrity issues, and evaluation to inform iterative refinements. The IPD Integrity Tool comprises 31 items (13 study-level, 18 IPD-specific). IPD-specific items are automated where possible, and are grouped into eight domains, including unusual data patterns, baseline characteristics, correlations, date violations, patterns of allocation, internal and external inconsistencies, and plausibility of data. Users rate each item as having either no issues, some/minor issue(s), or many/major issue(s) according to decision rules, and justification for each rating is recorded. Overall, the tool guides decision-making by determining whether a trial has no concerns, some concerns requiring further information, or major concerns warranting exclusion from evidence synthesis or publication. In our preliminary validation checks, the tool accurately identified all five studies with known integrity issues. The IPD Integrity Tool enables users to assess the integrity of RCTs via examination of IPD. The tool may be applied by evidence synthesists, editors and others to determine whether an RCT should be considered sufficiently trustworthy to contribute to the evidence base that informs policy and practice.

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Increasing integrity concerns in medical research have prompted the development of tools to detect untrustworthy studies. Existing tools primarily assess published aggregate data (AD), though scrutiny of individual participant data (IPD) is often required to detect trustworthiness issues. Thus, we developed the IPD Integrity Tool for detecting integrity issues in randomised trials with IPD available. This manuscript describes the development of this tool. We conducted a literature review to collate and map existing integrity items. These were discussed with an expert advisory group; agreed items were included in a standardised tool and automated where possible. We piloted this tool in two IPD meta-analyses (including 116 trials) and conducted preliminary validation checks on 13 datasets with and without known integrity issues. We identified 120 integrity items: 54 could be conducted using AD, 48 required IPD, and 18 were possible with AD, but more comprehensive with IPD. An initial reduced tool was developed through consensus involving 13 advisors, featuring 11 AD items across four domains, and 12 IPD items across eight domains. The tool was iteratively refined throughout piloting and validation. All studies with known integrity issues were accurately identified during validation. The final tool includes seven AD domains with 13 items and eight IPD domains with 18 items. The quality of evidence informing healthcare relies on trustworthy data. We describe the development of a tool to enable researchers, editors, and others to detect integrity issues using IPD. Detailed instructions for its application are published as a complementary manuscript in this issue.

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BACKGROUND: Involving the public in evidence synthesis research is challenging due to the highly analytic nature of the projects, so it is important that involvement processes are documented, reflected upon, and shared to devise best practices. There is a literature gap on the involvement of the public in individual participant data meta-analyses, particularly in public health projects. We aimed to document and reflect on our collective experiences of involving and being involved as public stakeholders at all stages of a systematic review and individual participant data meta-analysis project. METHODS: We formed a stakeholder group made of four members of the public at the beginning of our evidence synthesis project comprising a systematic review, an aggregate data meta-analysis, and an individual participant data meta-analysis of mindfulness-based programmes for mental health promotion in non-clinical adults. Following each group meeting, members and participating researchers completed written reflections; one group member collected and collated these. At the end of the project, a reflective writing workshop was held before all members completed their final reflections. Everyone completed an adapted, open-ended questionnaire which asked about what did and did not work well, the overall experience, what could be improved, and the felt impact the stakeholder group had on the research. RESULTS: Overall, the stakeholders and researchers reported a positive experience of working together. Positives from the stakeholders' point of view included learning new skills, experiencing research, and making new friends. For the researchers, stakeholders helped them focus on what matters to the public and were reinvigorating research partners. The challenges stakeholders experienced included having long gaps between meetings and feeling overwhelmed. The researchers found it challenging to strike the balance between asking stakeholders to be involved and for them to learn research-related skills without overburdening them and making sure that the learning was engaging. When looking back at their experience, stakeholders described seeing their impact on the project in hindsight but that this was not felt while the project was being carried out. CONCLUSION: Successfully involving the public in complex evidence synthesis projects is possible and valuable from the points of view of the researchers and the stakeholders. However, it requires a significant time, skill, and resource investment that needs to be factored in from project inception. Further guidance and stakeholder training materials would be helpful. Specific suggestions are provided.

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Unlabelled: Virtual reality (VR) is an immersive technology in which delivery of psychological therapy techniques can be automated. Techniques can be implemented similarly to real-world delivery or in ways that are not possible in the real world to enhance efficacy. The potential is for greater access for patients to effective therapy. Despite an increase in the use of VR for mental health, there are few descriptions of how to build and design automated VR therapies. We describe the development of Phoenix VR Self-Confidence Therapy, designed to increase positive self-beliefs in young patients diagnosed with psychosis in order to improve psychological well-being. A double-diamond, user-centered design process conducted over the course of 18 months was used, involving stakeholders from multiple areas: individuals with lived experience of psychosis, clinical psychologists, treatment designers, and VR software developers. Thirteen meetings were held with young patients diagnosed with psychosis to increase the understanding and improve the assessment of positive self-beliefs, help design the scenarios for implementing therapeutic techniques, and conduct user testing. The resulting Phoenix therapy is a class I United Kingdom Conformity Assessed (UKCA)-certified medical device designed to be used on the standalone Meta Quest 2 (Meta Platforms) headset. Phoenix aims to build up 3 types of positive self-beliefs that are connected to psychological well-being. In a community farm area, tasks are designed to increase a sense of mastery and achievement ("I can make a difference"); in a TV studio, users complete an activity with graded levels of difficulty to promote success in the face of a challenge ("I can do this"); and in a forest by a lake, activities are designed to encourage feelings of pleasure and enjoyment ("I can enjoy things"). Phoenix is delivered over the course of approximately 6 weekly sessions supported by a mental health provider. Patients can take the headsets home to use in between sessions. Usability testing with individuals with lived experience of psychosis, as well as patients in the National Health Service (aged 16-26 years), demonstrated that Phoenix is engaging, easy to use, and has high levels of satisfaction.

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BACKGROUND: Approximately 15% of births worldwide result in life-threatening complications during pregnancy, delivery, or postpartum. Comprehensive Emergency Management of Obstetric and Newborn Care (CEmONC) is intended as one of the measures for maternal healthcare services to reduce the high burden with regard to childbirth complications. However, its state of implementation fidelity has not been well investigated. Therefore, this study aimed to evaluate the implementation fidelity of CEmONC services at University of Gondar Comprehensive Specialized Hospital, Ethiopia. METHOD: A case-study design with an embedded mixed method was employed. Adherence, quality of delivery, and participant responsiveness dimensions from Carroll's conceptual framework were used in this evaluation. Four hundred four exit interviews, 423 retrospective document reviews and 10 key informants were conducted. Moreover, a binary logistic regression model was fitted. The qualitative data were transcribed, translated, coded, and analysed using a thematic analysis approach. The overall implementation fidelity of the CEmONC was judged based on the pre-seated judgmental criteria. RESULTS: Overall the implementation fidelity of the CEmONC service was 75.5%. Quality of delivery, participant responsiveness and adherence were 72.7%, 76.6% and 77.2% respectively. Signal functions like parenteral antibiotics and removal of retained products were insufficiently performed against the recommended protocols which was also evidenced by the key informant interviews. Healthcare providers' respect for the clients was less. Age ≥ 35 years (AOR = 0.48, 95% CI: 0.24,0.98), educational status of college and above (AOR = 2.61, 95% CI: 1.46,4.66), being government employed (AOR = 1.85, 95% CI: 1.08,3.18), having ANC follow-up (AOR = 5.50, 95% CI: 1.83, 16.47) and grand multigravida (AOR = 2.17, 95% CI: 1.08, 4.38) were factors significantly associated with participant responsiveness towards the services. CONCLUSIONS: The overall implementation fidelity of the CEmONC services was implemented in good fidelity. Moreover, the quality of delivery was judged as implemented in fair fidelity. Parenteral antibiotics and removal of retained products were not found to be sufficiently performed. Respect for the clients was insufficiently delivered. Therefore, it is recommended that parenteral antibiotics drugs be adequately provided and training for healthcare providers regarding compassionate and respectful care shall be facilitated. Moreover, healthcare providers are strongly recommended to adhere to the recommended guidelines.

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BACKGROUND: Severe psychomotor agitation and aggression often require immediate pharmacological intervention, but clear evidence-based recommendations for choosing among the multiple options are lacking. To address this gap, we plan a systematic review and individual-participant-data network meta-analysis to investigate their comparative effectiveness in real-world emergency settings with increased precision. METHODS: We will include randomized controlled trials investigating intramuscular or intravenous pharmacological interventions, as monotherapy or in combination, in adults with severe psychomotor agitation irrespective of the underlying diagnosis and requiring rapid tranquilization in general or psychiatric emergency settings. We will exclude studies before 2002, those focusing on specific reasons for agitation and placebo-controlled trials to avoid concerns related to the transitivity assumption and potential selection biases. We will search for eligible studies in BIOSIS, CENTRAL, CINAHL Plus, Embase, LILACS, MEDLINE via Ovid, PubMed, ProQuest, PsycINFO, ClinicalTrials.gov, and WHO-ICTRP. Individual-participant data will be requested from the study authors and harmonized into a uniform format, and aggregated data will also be extracted from the studies. At least two independent reviewers will conduct the study selection, data extraction, risk-of-bias assessment using RoB 2, and applicability evaluation using the RITES tool. The primary outcome will be the number of patients achieving adequate sedation within 30 min after treatment, with secondary outcomes including the need for additional interventions and adverse events, using odds ratios as the effect size. If enough individual-participant data will be collected, we will synthesize them in a network meta-regression model within a Bayesian framework, incorporating study- and participant-level characteristics to explore potential sources of heterogeneity. In cases where individual-participant data are unavailable, potential data availability bias will be explored, and models allowing for the inclusion of studies reporting only aggregated data will be considered. We will assess the confidence in the evidence using the Confidence in Network Meta-Analysis (CINeMA) approach. DISCUSSION: This individual-participant-data network meta-analysis aims to provide a fine-tuned synthesis of the evidence on the comparative effectiveness of pharmacological interventions for severe psychomotor agitation in real-world emergency settings. The findings from this study can greatly be provided clearer evidence-based guidance on the most effective treatments. SYSTEMATIC REVIEW REGISTRATION: PROSPERO CRD42023402365.

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Background: In the past, clinical trials run in India have been the subject of criticism. Among other steps to improve the trial ecosystem, for some time the government limited the number of trials that a Principal Investigator (PI) could run to three at a time. We were interested to know how many trials PIs in India tend to run at a time. Methods: We accessed the 52,149 trial records hosted by the Clinical Trials Registry-India in April 2023. Of these, we shortlisted trials that had run in India, were interventional, and involved certain interventions such as drug, biological etc. We used multiple parameters, such as email ID, phone number etc. to determine whether one name always represented the same PI and whether two names corresponded to the same PI. We then determined how many trials each PI had run. Results: We found that 3,916 unique PI names were associated with 6,665 trials. Of these, 2,963 (75.7%) PIs had run a single study. Only 251 (6.4%) had run more than three trials. A mere 14 PIs had run 20 or more trials. The 14 PIs were affiliated with local pharma companies (6), local or global contract research organizations (4), multinational pharma companies (3) and the Central Council for Research in Homeopathy (1). The maximum number of trials run by a single PI was 108. Of these, the largest number run in a single year, 2022, was 53. Conclusion: Each PI name needs to be connected to a unique ID that does not change with time, so that it is easier to track the number of trials that a given PI has run. The number of studies run by a given PI at a given time must not be excessive and needs to be monitored more actively. The government needs to consider whether a cap on the number of trials that a PI runs at a time is required and what infrastructure needs to be in place to facilitate higher numbers of trials. Trial registry records need to be updated more regularly. Other countries may wish to do likewise.