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Preprints posted in the last 30 days, ranked by how well they match BMJ Open's content profile, based on 554 papers previously published here. The average preprint has a 0.76% match score for this journal, so anything above that is already an above-average fit.

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Incidence and clinical predictors of Continuous Positive Airway Pressure (CPAP) failure among preterm neonates: a prospective clinical research study protocol.

Sisa, R. G.; Kalabamu, F. S. M.; Fataki, M. R.; Daud, N. A.; Sangey, A. I.; Leshabari, K. M.

2026-05-22 pediatrics 10.64898/2026.05.20.26353688 medRxiv
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Introduction: Newborn babies frequently encounter acute respiratory failure requiring assisted ventilation. Acute respiratory failure in infants commonly present in a form of respiratory distress syndrome. There are several studies that documented factors associated with CPAP failure rates among preterm newborns worldwide. However, they were either statistically underpowered or defined by overt design errors. The proposed study will estimate incidence rate and predictors of Continuous Positive Airway Pressure (CPAP) failure among preterm newborns delivered at representative hospitals in a typical urban area of Africa. Methods and analysis: a prospective longitudinal cohort observational, analytical study will be conducted at neonatal and emergency units of all Dar es Salaam public regional referral hospitals from March to (and including) August 2026. Newborns with CPAP failure will be the target population. Newborns without CPAP failure will be the control group. Follow up for each child will commence from the moment the child is subjected to CPAP until CPAP failure is clinically evident or day seven of life, whichever comes first. Interval assessment of the SAS scores (for CPAP potency) will be done using Silverman-Anderson score sheet in 4-6 hours intervals (unless otherwise dictated by the child clinical situation). The main outcome/dependent variable will be proportion of new CPAP failure per newborn-time of follow up. A multivariable linear model will be used to account for independent predictors of CPAP failure. Unless otherwise stated, an alpha-level of 5% will be used as a limit of type 1 error in findings. Ethics and Dissemination process: The study has received an IRB certificate (IRB reference: KU/IREC/27/10/639) from the Institutional Research Ethics Committee of KU. Permission to recruit the affected children has been sought from Municipals based hospitals directors of Amana, Mwananyamala and Temeke regional referral hospitals respectively. Written informed consent will be sought from mothers of all recruited newborn babies.

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MIS-CYTO: A prospective, multi-center, observational study for validation of oncological adequacy of minimally invasive cytoreductive surgery for peritoneal malignancies with limited peritoneal spread at systematic mini-laparotomy by INDEPSO

Kazi, M.; Sukumar, V.; Mehta, S.; Pawar, A.; Patel, S.; Mishra, D.; Garach, N.; Kammar, P.; Usofi, Z.; Sinukumar, S.; Iyer, R.; Sharma, V.; Chatterjee, A.; Patel, A.; Ranade, R.; Prabhu, A.; Damodaran, D.; Seshadri, R. A.; Kusamura, S.; Saklani, A.; Van Der Speeten, K.; Bhatt, A.

2026-05-25 oncology 10.64898/2026.05.23.26353919 medRxiv
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Background The role of minimally-invasive cytoreductive surgery (MI-CRS) in low volume peritoneal disease has been explored but lacks robust evidence demonstrating oncological adequacy and non-inferiority to open CRS. The major challenges of MI-CRS are its technical complexity and chances of missing disease which could have detrimental oncological outcomes. The only means of resolving the dilemma of missed disease is to convert the procedure to open surgery and confirming the findings of MI approach. The Minimally InvaSive CYTOreductive surgery (MIS-CYTO) study is a prospective observational study that will evaluate the oncological adequacy of MI-CRS at systematic mini-laparotomy in patients with low volume peritoneal disease. Methods This single-arm study which will include 100 patients with primary and secondary peritoneal malignancies with a peritoneal cancer index (PCI)< 10 treated by MI-CRS. Patients will be recruited over 3 years and followed up for 5 years. All patients will undergo a staging laparoscopy (SL) with video documentation according to the study format. Patients who undergo subsequent MI-CRS will be included in the per-protocol population. At the end of MI-CRS video documentation of the resection sites is performed followed by a systematic mini-laparotomy for exploration of the abdominal cavity for any residual disease. The presence of residual disease will be confirmed on pathological evaluation. The primary end point is the incidence of missed disease during MI-CRS that is detected during mini-laparotomy. Quality assessment of SL and MI-CRS will be performed by an independent two-member committee. Patients undergoing conversion to open cytoreductive surgery will comprise the comparator group for studying the secondary end-point which include the sites of missed disease, perioperative outcomes and survival outcomes. Survival endpoints will be measured from the date of surgery to the event: overall survival (OS) will be defined by death due to any cause, and progression-free or relapse-free survival (PFS/RFS) by any recurrence or death whichever comes first. Ethics and Registration The study protocol is approved by the ethics committee of Shalby Cancer and Research Institute on 7th October 2024 (EC/069/02). The study is registered under the Clinical Trials Registry of India; subsidiary of clinicaltrials.gov (CTRI/2024/11/076312). Strengths and limitations The study will be the first to demonstrate the oncological adequacy or inadequacy of the MI-CRS The methodology and surgical protocol are robust and should minimize heterogeneity in surgical practices in the study If the oncological inadequacy of MI-CRS is not demonstrated, its use should be limited in patients with limited peritoneal disease. Two independent experts will review the adequacy of staging laparoscopy and MI-CRS both The stringent methodology could be a deterrent for surgeons/ centres to participate in the study, specifically performing a systematic mini-laparotomy for those surgeons who prefer to deliver specimens through a natural orifice.

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Characteristics of Highly Creative Surgeons (The INSPIRE Study): An International Mixed-Methods Study Protocol

Thabane, A.; McKechnie, T.; Staibano, P.; Scheau, C.; Dragosloveanu, S.; Guerra Farfan, E.; Sajol, R. R.; Arora, V.; Calic, G.; Parpia, S.; Busse, J. W.; Hamoudi, N.; Patel, D.; Reiter-Palmon, R.; Bhandari, M.

2026-05-19 surgery 10.64898/2026.05.15.26353308 medRxiv
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Introduction Creativity is important in surgery for problem-solving in the operating room and the development of surgical innovations that improve patient outcomes. However, our limited understanding of what the characteristics and competencies of the highly creative surgeon are has inhibited our ability to develop the tools, programs and interventions necessary for cultivating the creativity of surgeons. We present the protocol for the INSPIRE Study, which aims to identify the factors associated with high creative achievement in surgeons. Methods and Analysis We have designed a sequential mixed-method study, including a cohort study accompanied by qualitative semi-structured interviews. The primary objective of this study will be to identify factors associated with high creative achievement in surgeons, to be assessed through direct involvement in innovation or invention, or a top score (10 out of 10) on any domain in the Inventory of Creative Activities and Achievements questionnaire. We plan to measure 39 different personal, domain-specific, domain-general, and environmental/motivational variables, chosen based on previous literature and on exploratory grounds, to be assessed as possible factors of creative potential. Multivariable logistic regression is planned, with high creative achievement as the dependent variable and all 39 potential factors of creative potential as independent variables. Ethics and Dissemination Ethics approval from the Hamilton Integrated Research Ethics Board has been obtained and no harm is expected due to participation in this study. To facilitate knowledge translation, we plan to publish the feasibility data and results in peer-reviewed journals, and present at international surgical and creativity conferences.

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Experiences of families using an early example of neighbourhood multidisciplinary care for children and young people: A qualitative exploration using the theoretical framework of acceptability

Litchfield, I.; Dutton, F.; Harper, L.; Kaur, S.; Luxmoore, C.; Rahman, L.; Wolhuter, C.; Bird, C.

2026-05-19 primary care research 10.64898/2026.05.14.26353240 medRxiv
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Background In the United Kingdom, the National Health Service is attempting to address the ongoing challenges to heath equity in underserved children and young people (CYP) by creating Neighbourhood Multi-Disciplinary Teams (NMDTs) that combine health services, social care providers, local authorities, voluntary, community and faith and social enterprise is needed. Despite this significant shift in the delivery of care, there is a lack of suitably robust evidence of family experience to inform their development. This work contributes to this need using the experience and perspectives of families using the experience and perspectives of families using an early example of an NMDT for CYP the Sparkbrook Children's Zone in Birmingham, United Kingdom. Methods The study used data collected from two focus groups conducted with parents whose children had been treated by the Sparkbrook Children's Zone. The data were analysed using a directed content analysis to populate Sekhon's Theoretical Framework of Acceptability. Results In summary and by framework domain, we found that that individuals became aware of the SCZ through a range of sources, understanding that it was multidisciplinary if sometimes unsure of precisely the organisations involved (Intervention coherence) Parents described the benefits to access of a locally situated collocated service (Burden) the personalised relationship with providers (Cultural sensitivity0 extended conultation time, and support for the family's complex clinical needs (Perceived effectiveness) Conclusions Parents appeared to prefer the SCZ over usual primary care but more work is needed with larger sample sizes to ensure that the structure of NMDTs are understood and optimised.

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Effectiveness and cost-effectiveness of orthopaedic modifications to off-the-shelf footwear for people with first metatarsophalangeal joint osteoarthritis: study protocol for a randomised controlled trial

Veenstra, S.; Hulshof, C. M.; Bosmans, J. E.; Schiphof, D.; van der Grinten, M.; Kloprogge, S. E.; Braam, C.; Nugteren, L.; Bierma-Zeinstra, S. M. A.; van Middelkoop, M.

2026-05-15 orthopedics 10.64898/2026.05.12.26352874 medRxiv
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Introduction: Osteoarthritis (OA) is a chronic joint disease, often leading to pain, joint stiffness and impaired function. The first metatarsophalangeal (MTP-1) joint is the most frequently affected joint in foot OA. Footwear interventions might have potential to reduce pain for people with MTP-1 joint OA. The aim of this study is to determine the effectiveness and cost-effectiveness of orthopaedic modifications to off-the-shelf footwear in addition to usual care, compared to usual care alone, for people with MTP-1 joint OA. Methods and analyses: We perform a pragmatic, non-blinded, two-armed, parallel-group, randomised controlled trial (RCT). A total of 136 people with MTP-1 joint OA and presence of foot pain are recruited. Participants are randomised to orthopaedic modifications to off-the-shelf footwear in addition to usual care or to usual care alone. The footwear modifications comprise a combination of sole-stiffening, rocker sole adjustments and custom-made insoles. During a 12-month follow-up period, participants receive monthly questionnaires. Primary outcomes include walking pain at 6-month follow-up and quality-adjusted life years and societal costs at 12-month follow-up. Secondary outcomes include walking pain at 12-month follow-up and foot health, physical activity level, patient acceptability and self-reported recovery at 6- and 12-month follow-up. Intention-to-treat and per-protocol analyses will be performed using (generalised) linear mixed models. Ethics and dissemination: The study is approved by the local Medical Ethics Committee of the Erasmus MC University Medical Center Rotterdam, The Netherlands (MEC-2024-0615). Prior to study participation, participants provide informed consent. Results will be disseminated amongst researchers through peer-reviewed scientific articles and presentations at conferences; and amongst people with MTP-1 joint OA and healthcare professionals through layman articles in newsletters, on websites and on social media. Discussion: This is the first RCT to investigate the effectiveness and cost-effectiveness of orthopaedic modifications to off-the-shelf footwear in addition to usual care, compared to usual care alone for people with MTP-1 joint OA. Study findings will support healthcare professionals in making substantiated decisions in the treatment of people with MTP-1 joint OA.

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Development, Validation, and Implementation of a Stress Management Intervention for Rescue Workers in Rawalpindi: A protocol for a mixed-method study

Yasir, I.; Ahmad, I.; Bhatti, U. F.; Khan, S. A.; Malik, A.

2026-05-12 public and global health 10.64898/2026.05.09.26352786 medRxiv
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IntroductionOccupational stress among rescue workers is a major global public health concern. Rescue workers, including paramedics, firefighters, and disaster response teams, are consistently exposed to traumatic events, long working hours, physical hazards, and emotionally charged situations. These chronic stressors make them one of the most vulnerable groups to psychological distress, burnout, anxiety, depression, and post-traumatic stress disorders. In the local context of Pakistan, workplace mental health remains a neglected area. Despite stress and burnout being widely reported in these sectors, limited evidence-based interventions are available. Therefore, the study aims to develop and evaluate a locally tailored intervention to improve the mental health and psychosocial well-being of rescue workers. ObjectivesO_LITo develop a culturally appropriate stress management intervention to promote mental health for rescue workers in Rawalpindi. C_LIO_LITo validate the content and structure of stress management intervention for rescue workers C_LIO_LITo evaluate the effectiveness of stress management intervention for rescue workers in Rawalpindi C_LI MethodThe ethical approval of the study has already been obtained from the ethical review board of Health Services Academy (00013/HSA/PhD-2022) and Rescue 1122 District Headquarters, Rawalpindi. Data will be collected after obtaining informed written consent from relevant stakeholders. Data collection will start from April 2026 and will be completed in six months. Data compilation and results are expected by December 2026. Data collection will involve a scoping review to explore stress determinants and intervention components, and then a qualitative phase in which data will be collected through focus group discussions from potential Stakeholders (rescue workers, mental health experts, and program managers) to identify and validate stress determinants. Triangulation of data will be done to integrate qualitative findings with findings from the review. In the second phase, validation will be done by intervention development experts. The third phase aims to evaluate the effectiveness of the developed intervention using a quasi-experimental pre-post design. A total of 154 participants evaluated with the Perceived Stress Scale Score will be employed through a stratified sampling technique. The primary outcome is defined as remission from stress at 3 months, measured with the PSS. DiscussionIt is anticipated that the study will result in the development of a culturally appropriate and evidence-based stress management intervention for rescue workers, thus contributing to sustainable improvement in rescuers mental health and job performance.

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BREATHE: A realist evaluation protocol to understand how smoking cessation services support pregnant women in areas of social deprivation

Carlisle, N.; Zhang, M.; Simpson, N.; Stacey, T.

2026-06-10 obstetrics and gynecology 10.64898/2026.06.04.26354590 medRxiv
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Background Tobacco smoking during pregnancy increases the risk of preterm birth, small for gestational age (SGA), stillbirth, and longer-term adverse health outcomes. Globally, reducing smoking in pregnancy is a key public health priority, yet the organisation, accessibility, and effectiveness of cessation support varies substantially between countries and healthcare systems. Differences in policy implementation, resource allocation, and integration of cessation services into antenatal care influence uptake and success rates across diverse settings. In England, pregnant women are entitled to free smoking cessation support, however, service delivery varies across regions with mixed efficacy. While tobacco smoking is more prevalent in deprived communities, there is limited understanding of how, why, for whom, and under what circumstances these services are most effective, particularly in areas of social deprivation, such as the North East and Yorkshire. Objective To conduct a realist evaluation to understand how smoking cessation services support pregnant women in areas of social deprivation to stop smoking and reduce adverse perinatal outcomes. Methods This multi-site realist evaluation will be conducted across three NHS maternity services in West Yorkshire, England. The study comprises four iterative stages: (1) development of initial programme theories through realist-informed literature scoping and stakeholder consultation; (2) case study data collection including qualitative interviews with pregnant women (approximately 15-30) and staff (approximately 15-30); (3) analysis of routine anonymised maternity and neonatal electronic data collected over a one-year period; and (4) realist analysis to refine context-mechanism-outcome (CMO) configurations. Qualitative data will be analysed using realist logic supported by NVivo software. Quantitative data will be analysed using descriptive and inferential statistics to explore associations between smoking cessation engagement and perinatal outcomes. Ethics and dissemination Ethical approval was obtained through the UK Health Research Authority and a Research Ethics Committee prior to study commencement (IRAS 364173; REC reference number 26/SC/0020). Findings will inform recommendations to improve smoking cessation support for pregnant women in deprived areas. Results will be disseminated through peer-reviewed publications, conference presentations, and stakeholder engagement.

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Ejaculatory Function and Clinical Outcomes Following Robotic Aquablation for Prostatic Bladder Outflow Obstruction: A Retrospective Real-World Cohort Study Protocol

Shroff, D. E.; Newman, T.; Malde, S.; Martyn-Hemphill, C.

2026-05-30 urology 10.64898/2026.05.28.26354125 medRxiv
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Introduction Aquablation for surgical treatment of benign prostatic enlargement (BPE) causing bladder outflow obstruction (BOO) has demonstrated good functional outcomes, even for large glands, with high rates of ejaculatory preservation reported. This is a protocol for a study that aims to review real-world outcomes of ejaculatory preservation or restoration post-Aquablation in an unselected cohort and compare to published clinical trial outcomes. Methods Retrospective data will be collected from a prospectively maintained consecutive case series of patients who underwent Aquablation, in a single UK centre. The primary outcome is ejaculatory function subjectively reported by men post-operatively, and classified as: antegrade ejaculation, retrograde/low volume ejaculation, anejaculation or not sexually active. Secondary outcomes are International Prostate Symptom Severity (IPSS), Quality of Life (QoL) Score, post-void residual (PVR), and incontinence. Descriptive and comparative statistical tests will be performed. Conclusions This study will review real-world ejaculatory function and clinical outcomes following robotic Aquablation for prostatic bladder outflow obstruction and compare this to published clinical trial outcomes.

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Influence of Personality Traits on Mental Health and Performance of Medical Residents and Physicians: A Systematic Review and Meta-analysis

Garoot, W.; Leaune, E.; Echevarria, C.; Lilot, M.; Rodes, G.; Schlatter, S.

2026-05-15 medical education 10.64898/2026.05.11.26351770 medRxiv
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Abstract Background: Medical residents and physicians face persistently high-demand environments marked by heavy workloads, time pressure, night duties, and emotionally intense clinical encounters. These conditions increase vulnerability to stress-related outcomes, including burnout and impaired mental health, and can affect functioning at work. Personality traits are relatively stable individual differences and might help explain why some doctors experience greater stress vulnerability or use less adaptive coping strategies than others. Evidence linking the Big Five personality traits to stress, coping, and performance outcomes in residents and physicians has grown, but it remains difficult to apply because of inconsistent findings and heterogeneous measures. This systematic review and meta-analysis aim to synthesize the existing literature on how the Big Five personality traits influence these outcomes in medical residents and physicians. Methods: We conducted a PRISMA-aligned systematic review and meta-analysis (PROSPERO CRD42023483408). PubMed, Embase, MEDLINE (Ovid), Cochrane Library, Scopus, and Web of Science were searched from database inception to Nov 15, 2023. Searches were updated periodically through Jan 2026. Eligible studies were primary research in English involving medical residents and/or practicing physicians that assessed at least one Big Five trait using a recognized Five-Factor Model instrument and reported an association with a validated or clearly defined stress, coping, performance, or professional skills/aptitudes related outcome in medical residents or physicians. Studies exclusively involving medical students were excluded. Risk of bias was assessed using the AXIS tool (supplemented by Joanna Briggs Institute items) for cross-sectional studies and the Cochrane Risk of Bias 2 tool for the randomized trial. Where at least three comparable studies were available, effect sizes were pooled using random-effects models with restricted maximum likelihood estimation after Fishers z transformation; remaining studies were synthesized narratively. Results: Of the 4,967 records identified, 34 studies (21,379 participants) met the inclusion criteria; most were cross-sectional (30/34), with three longitudinal studies and one randomized trial. Meta-analyses were restricted to 11 studies reporting Maslach Burnout Inventory subscales and three studies reporting GHQ-12 psychological distress. Neuroticism showed the clearest and most consistent adverse associations: for emotional exhaustion (pooled r=0.418, 95% CI 0.219 to 0.616, p<0.001), for depersonalization (pooled r=0.304, 95% CI 0.166 to 0.442, p<0.001), and for personal accomplishment (pooled r=-0.244, 95% CI -0.393 to -0.094, p=0.005). Conscientiousness, Extraversion, and Agreeableness showed small protective patterns, with lower emotional exhaustion and depersonalization and higher personal accomplishment, although associations with stress were weak and generally non-significant. Openness showed a weaker, selective pattern, with lower depersonalization and higher personal accomplishment, but no clear association with emotional exhaustion or stress. Moderator analyses suggested that associations for Neuroticism, Conscientiousness, and Agreeableness varied more by experience and region than by specialty, whereas Extraversion was moderated mainly by experience; Openness showed little evidence of consistent moderation. Narrative synthesis of studies not included in the main meta-analyses was broadly concordant: Neuroticism was the most consistent vulnerability marker for burnout, distress, maladaptive coping, and poorer work-related outcomes, whereas Conscientiousness and, to a lesser extent, Extraversion were linked to more adaptive coping and more favorable performance-related indicators. Agreeableness showed modest prosocial and attitudinal benefits, and Openness remained the least consistent trait across outcomes. Overall risk of bias was low to moderate for most observational studies, although heterogeneity was substantial across pooled analyses. Conclusions: Big Five personality traits have modest correlation with physicians and residents burnout, distress, coping, and work-related functioning. Neuroticism emerged as the clearest vulnerability marker, whereas Conscientiousness and, to a lesser extent, Extraversion and Agreeableness showed small protective associations. Interpretation is limited by the predominance of cross-sectional designs, reliance on self-report, substantial heterogeneity, and restricted geographic representation. These findings support the use of personality traits as a supportive and formative resource within medical education and workforce well-being, but not for deterministic selection or labelling. Larger longitudinal and intervention studies using multi-method outcomes are needed to clarify mechanisms and causal pathways.

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WELL-ED: Wellbeing and Education linkages in school-aged children - A protocol for a population-based register study and survey of adolescents

Kosola, S.; Salonen, S.; Miettinen, J.; Horhammer, I.; Impio, A.-R.; Kumpulainen, S. M.; Sergejeff, J.; Numari, S.; Laitinen-Parkkonen, P.; Tapola-Haapala, M.; Aaltio, E.; Thorn, L.

2026-06-08 public and global health 10.64898/2026.06.06.26355053 medRxiv
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Introduction Education is a core social determinant of health for children and adolescents. Unfortunately, academic achievement, health, and wellbeing of adolescents have decreased in many developed countries in the past decade. The purpose of the Wellbeing and Education linkages in school-aged children (WELL-ED) study is to examine associations of school absences and academic achievement with use of school-based and community-based health and social welfare services. In addition, we will assess user experiences and multi-sector services pathways of school-aged children for a better understanding of how the service system could respond to the needs of children. Methods and analysis WELL-ED is a large population-based study that combines register data on school absences and educational support from municipalities with register data on healthcare and social service use collected from wellbeing services counties in Finland. The study cohort includes all children who attended mandatory education in public schools in Southern Finland in school year 2023-2024. A smaller cohort of adolescents in school year 8 was invited to complete a user experience survey. The primary outcomes of this study are related to equity of service use. Ethics and dissemination The Regional Committee on Medical Research Ethics of the Helsinki and Uusimaa Hospital District (2803/2024) has approved the WELL-ED study protocol. For the survey, adolescents in year 8 and parents of adolescents younger than 15 provided informed consent. Results will be published in peer-reviewed journals, summaries will be sent to participating municipalities and wellbeing services counties and press releases will be written on key findings.

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Associations of Power Distance and Psychological Safety With Medical Researcher Well-being

Choi, J.; Kim, Y. J.; Luan, Y. L.

2026-05-19 medical education 10.64898/2026.05.15.26353300 medRxiv
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ABSTRACT OBJECTIVES To examine whether psychological safety and power distance are associated with medical researchers' well-being, and whether these associations operate through team inclusiveness and conflict. DESIGN Cross-sectional survey study. SETTING A biomedical research institute at a major UK university. PARTICIPANTS 133 medical researchers from 17 teams, including 20 principal investigators and 113 team members. MAIN OUTCOME MEASURES Job satisfaction, life satisfaction, intrinsic motivation, and psychological detachment. Mediators were dimensions of team inclusiveness and team conflict. RESULTS Psychological safety had no significant direct associations with job satisfaction, life satisfaction, intrinsic motivation, or psychological detachment, but showed several indirect associations through researchers' team experiences. It was indirectly associated with higher job satisfaction, life satisfaction, and intrinsic motivation primarily through greater integration of differences, inclusion in decision making, or more constructive forms of conflict (bs=.23-.38, ps=.032-<.001).For psychological detachment, psychological safety showed conflicting indirect associations: it had the potential to support detachment through greater integration of differences and lower avoidant conflict (bs=.21-.56, ps=.054-.002), but to undermine detachment through greater inclusion in decision-making (b=-.26, p=.082). Power distance showed a different pattern. Most notably, it was positively associated with psychological detachment (b=.54, p=.062). However, power distance was indirectly associated with lower job satisfaction, life satisfaction, and intrinsic motivation, primarily through reduced integration of differences and greater dominating conflict (bs=-.14 to -.19, ps=.068-.020). CONCLUSIONS Common assumptions about psychological safety and power distance should be revisited. Psychological safety did not show strong direct benefits for researcher well-being, whereas power distance was not uniformly harmful and was positively associated with psychological detachment. A more nuanced understanding of both cultural dimensions is needed in medical research teams.

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Precision Imaging to Evaluate Kaposi Sarcoma (PRIME-KS): protocol for a multicountry novel artificial intelligence-based imaging device

Odeny, T. A.; Adhiambo, H. F.; Mangale, D.; Makanga, P. K.; Odeny, B.; Okuku, F.; Zhou, C.; Geng, E.; Carson, J.; Mudhune, V.; Bukusi, E.; Semeere, A.

2026-06-04 oncology 10.64898/2026.06.03.26354815 medRxiv
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Abstract Background: Kaposi sarcoma (KS) is the most common cancer among men in several Eastern African countries, yet treatment monitoring relies on imprecise, time-consuming ruler-based measurements defined by the AIDS Clinical Trial Group (ACTG). This method suffers from inter-observer variability, fails to capture lesion height or true geometric area, and performs poorly on dark skin. SkinScan3D (SS3D) is a portable, low-cost, AI-enabled 3D imaging device that provides objective measurements of KS skin lesion area, height, volume, and color. The Precision Imaging to Evaluate Kaposi Sarcoma (PRIME-KS) study evaluates whether SS3D provides more reproducible and accurate lesion measurements than the standard method, and validates its integration into routine clinical workflows in Kenya and Uganda. Methods: PRIME-KS is a multicountry prospective mixed-methods study with two clinical objectives. Objective 1 is a cross-sectional diagnostic accuracy study comparing SS3D with ruler-based measurement in 50 adults with KS (150 lesions) across sites in Kenya and Uganda. Two clinicians independently measure three lesions per participant using both methods. The primary outcomes are concordance correlation coefficient (CCC) for inter-rater reproducibility, and co-efficient of determination for accuracy. Objective 2 is a non-randomized before-and-after pilot study in 100 patients at three sites, evaluating device usability, acceptability, appropriateness, and feasibility using validated instruments, along with time-and-motion studies and activity-based micro-costing. Prior to these clinical objectives, a formative study used focus group discussions, discrete choice experiments, and human-centered design workshops to refine the SS3D device and protocols with end-user input. Discussion: PRIME-KS will provide the first rigorous evaluation of a 3D imaging device for monitoring KS treatment response in routine clinical settings. If SS3D demonstrates superior reproducibility and clinical utility, it could reduce unnecessary chemotherapy exposure and associated toxicities by enabling earlier, more objective assessment of treatment response. Trial registration: ClinicalTrials.gov NCT06898203, registered 27 March 2025. Pan African Clinical Trials Registry PACTR202603523439856. Keywords Kaposi sarcoma, SkinScan3D, 3D imaging, treatment monitoring, diagnostic accuracy, implementation science, usability, human-centered design, Kenya, Uganda

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What outcome information do women need to support an informed choice between planning a vaginal or caesarean birth? - a consensus study.

Ekong, A.; Nicoll, A.; Locock, L.; Fairley, T.; Devane, D.; McDonagh Hull, P.; Braithwaite, L.; Ade, M.; Hidvegi, I.; Saldias, N.; Taylor, G.; Williams, D.; Bhattacharya, S. B.; Black, M.

2026-05-17 obstetrics and gynecology 10.64898/2026.05.13.26352976 medRxiv
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Background A mode of birth decision aid (DA) can provide information and support discussions about the potential risks and benefits (outcomes) associated with planning a vaginal or caesarean birth. Evidence shows that DAs can enhance patient knowledge, reduce decisional conflict, minimise inconsistencies in decision-making support, especially in maternity settings, and promote informed decision making. Despite these benefits, DAs specific to mode of birth are currently lacking in routine antenatal care. This paper outlines the process we followed to reach consensus on which outcomes of planned mode of birth should be included in a mode of birth DA. Methods Outcome identification and selection occurred in three phases. Phase 1 involved compiling a long list of outcomes from systematic reviews, the NICE Caesarean Birth Guidance and qualitative interviews with stakeholders. In Phase 2, this list was refined via a 2 round Delphi survey to prioritise outcomes considered important. An outcome reached consensus if [&ge;]70% of all participants, or 70% of women/partners rated it as critically important (7-9), and <15% rated it as not important (1-3). Phase 3 involved two stakeholder consensus meetings to finalise the outcome list. Results Seventy-one outcomes were identified. Following two Delphi rounds and consensus meetings, 54 outcomes were rated as critically important. Seventeen outcomes were consistently rated as not critical across both the survey and consensus phases, meaning that [&ge;]70% of participants in each phase did not consider them essential for informing women during pregnancy. Of these, 8 were retained due to NICE recommendations and ultimately, 9 outcomes were excluded. The final list included 44 maternal and 18 child outcomes. Maternal outcomes related to assistance with birth, complications at the time of birth, issues during recovery, pelvic floor, psychological issues, sexual function, and future pregnancy. Child outcomes related to morbidity and death, disease, obesity, issues with cognitive development and physical development. Conclusions Sixty-two priority outcomes were identified for inclusion in a planned mode of birth DA.

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Education/training for health workers/students on inclusive and gender-affirmative care for trans and gender-diverse people: a systematic review

Xia, J.; Zhu, Z.; Zhang, G.; Shen, Q.; Su, E.; Schoones, J.; Arcelus, J.; Hu, T.; Xu, M.; Zhang, X.; Zhao, Z.; Ye, Z.; Yao, X.

2026-06-05 health policy 10.64898/2026.06.04.26354880 medRxiv
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Introduction: Trans and gender-diverse (TGD) individuals often face stigma and discrimination in healthcare, hindering access to gender-affirming care. Training healthcare workers on TGD health aims to foster inclusive and affirming care practices. This review aimed to evaluate the effectiveness of TGD health training programs for healthcare workers. Methods: This systematic review followed the PRISMA guidelines and was registered with PROSPERO (CRD42023443288). We searched 13 databases for studies up to March 2024, with no language/geographic restrictions. Ten reviewers screened studies in pairs, resolving discrepancies via discussion or third-reviewer input. We included randomized/non-randomized comparative and before-after studies for quantitative analysis (mean difference [MD] or standardized mean difference [SMD] with 95% CIs) and qualitative/mixed-methods studies for thematic synthesis. Evidence certainty was assessed using GRADE (quantitative) and GRADE-CERQual (qualitative). Outcomes included knowledge, attitudes, skills, discrimination, competence, comfort, TGD quality of life, and stakeholder preferences. Results: From 20,188 records, 85 studies were included. Training appears to have improved healthcare workers' knowledge (SMD=1.08, 95% CI 0.78-1.39), attitudes (SMD=0.22, 95% CI 0.05-0.39), skills (SMD=0.96, 95% CI 0.56-1.37), competence (SMD=0.55, 95% CI 0.29-0.81), and comfort (SMD=0.69, 95% CI 0.17-1.21). Qualitative analysis of 130 findings identified 18 categories and four key themes on intervention design and impact. Conclusions: TGD training programs may enhance health workers' knowledge, attitudes, skills, competence, and comfort. Well-structured, interactive, and inclusive programs showed promise, but evidence certainty was low with limited follow-up. Further high-quality research is needed to confirm these findings.

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Operational Enablers and Barriers in Hospital Incident Command: Insights from a Single-Center Table-Top Exercise at a Tertiary Care University Hospital-A Qualitative Phenomenological Study

Ries, M.; von der Forst, M.; Schaefer, H.; Bikowski, K.; Franzen, K.; Geoerg, P.; Weykamp, F.; Popp, E.; Kuellenberg, J.

2026-05-17 emergency medicine 10.64898/2026.05.13.26353139 medRxiv
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Background: In crises, hospitals must rapidly shift from routine operations to structured crisis management, requiring the activation of an incident command system. However, empirical insight into their operational functioning during activation remains limited. Goal: to identify operational enablers and barriers influencing effective crisis response. Methods: Prospective cross-sectional, qualitative, single-center study conducted after a table-top exercise within a hospital incident command system at a tertiary care university hospital (NCT06913010). Data was collected through semi-structured interviews, participant observation, and document analysis, and analyzed using a narrative-phenomenological approach. Results: Nineteen participants were included. Analysis identified nine thematic clusters shaping operational performance: (1) structure and roles; (2) communication; (3) decision-making and prioritization; (4) information management; (5) infrastructure and technology; (6) personnel and organization; (7) training, exercises, and team dynamics; (8) documentation; and (9) external communication and media. Enablers included clear role definition, structured communication, phased decision-making, and regular training. Barriers included role ambiguity, fragmented communication, insufficient prioritization, infrastructure limitations, and staffing constraints. Conclusion: Preparedness frameworks are necessary but insufficient as stand-alone approaches, as operational execution determines real-world performance. Recurring deficits included unclear roles, inconsistent communication, weak prioritization, and gaps in infrastructure and personnel. A limited set of standardized practices - including a clear separation od roles, leadership intent, closed-loop communication, explicit decision cycles from information gathering to structuring to decision-making, checklists, visualization, central information management, and rapid "80% decisions"-substantially enhanced performance. Mission command (Auftragstaktik) further enabled adaptive, coordinated action. Strengthening hospital incident command is a key lever for achieving system-level resilience in crises.

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Protocol for: Lockable Smartphone Pouches in UK Secondary Schools. A Cohort Study

John, J.; Khambhayta, A.; Lange, M.; Maher, F.; Localleti, C.; Kalk, N.; Carter, B.

2026-05-21 health policy 10.64898/2026.05.15.26353291 medRxiv
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Background Smartphone ownership among UK adolescents is near universal. Teachers report phones increasingly being involved in classroom disruption, and misuse during school hours is among the more common serious behavioural issues in secondary schools. Evidence on whether restrictive policies improve behaviour, attainment, or wellbeing remains limited. Objectives The primary objective is to assess the impact of a lockable smartphone pouch on educational attainment and behaviour. Secondary objectives are to assess impacts on general functioning, psychological wellbeing, and school level indicators such as exclusions, and to examine whether effects differ for pupils who may be most at risk. Methods We will conduct a mixed methods cohort study in secondary schools across Northern Ireland and England during the 2025 to 2026 academic year. The quantitative component uses a serial cross sectional design. Students will complete an online questionnaire at 0, 4 weeks, and 8 weeks, covering homework completion, classroom disruption, participation in PE and extracurricular activities, peer interaction during break, and patterns of smartphone use. Measures include the Strengths and Difficulties Questionnaire (SDQ), the Revised Child Anxiety and Depression Scale (RCADS), the short form of the Smartphone Addiction Scale (SAS SV), and the Bergen Social Media Addiction Scale (BSMAS). Each participating school will also supply half termly aggregate data on exclusions, detentions, CAMHS referrals, counsellor visits, and parent visits between September 2023 and May 2026. Assuming 90% power, a two-sided type 1 error of 0.05, an intracluster correlation of 0.02, and 25% loss to follow up, we aim to recruit a minimum of 3,200 students from six or more schools to detect a small effect (Cohen's d = 0.2) on SDQ hyperactivity score. Continuous outcomes will be analysed with linear regression and binary outcomes with logistic regression. Prespecified subgroup analyses cover SEN or neurodivergent status, area level deprivation, and which phone policy is in place at each school. Qualitative analyses comprise focus groups with students and staff at each participating school and semi-structured interviews with school leads. Transcripts will be coded both inductively and deductively and analysed thematically with Braun and Clarke's six phase approach. Ethics and Dissemination The study has been approved by the King's College London Research Ethics Committee. A Data Protection Impact Assessment has been agreed with the Northern Ireland Department of Education. Findings will be published in peer reviewed journals and shared with participating schools, parents, and policy makers to inform smartphone policy in schools.

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Neurodiversity in the Paediatric Chronic Pain Clinic: An Audit

Buechner, H.; Themistokleous, G.; Orr, M.; Lawson, E.; Smart, E.; Donaghy, A.; Wallace, E.

2026-06-03 pediatrics 10.64898/2026.06.02.26354725 medRxiv
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Objective: To compare the characteristics, management and outcomes of neurodivergent (ND) children with neurotypical (NT) children attending a chronic pain clinic. Design: An audit of all patients attending the clinic from 2010-2025 using electronic patient records. Setting: A tertiary pain centre in Scotland. Patients: 724 patients were included in the analysis, 193 (26%) were neurodivergent. Patients were included if they had a documented referral to the pain clinic and attendance to at least one clinic appointment. Patients were excluded if no pain clinic letter could be found on their records. Results: There was a significant increase in the percentage of children with neurodiversity attending the chronic pain clinic compared to neurotypical children (p = 0.004) accounting for over a third of children last seen in the period of 2023-2025. ND children were most likely to present with musculoskeletal pain compared with NT children (p = 0.033) representing over half of all ND children's presentations with pain. ND children were more likely to report being bedbound (18% ND, 13% NT, p = 0.0352) or needing a walking aid (40% ND, 25% NT, p = 0.000) due to chronic pain and had a higher number of referrals (ND median = 18.4, 1QR, NT median = 12.44, IQR10.28 p = 0.000). ND children were more likely to live in areas of deprivation (Cochran-Armitage test, Z -2.15, p = 0.0315). Conclusions: Children with neurodiversity are overrepresented in the chronic pain clinic, and more often present to tertiary services with musculoskeletal pain. They are more likely to have multiple referrals, spend longer with the pain service and less likely to be discharged due to pain improvement. These findings highlight the need for focused strategies to address chronic pain in neurodivergent children. Services should consider how best to identify and support children with neurodiversity and chronic pain. Key Messages {middle dot} What is already known on this topic: While there has been research regarding the role of neurodiversity in pain perception, there are gaps in knowledge regarding the influence of neurodiversity on the development and persistence of chronic pain in children. {middle dot} What this study adds: A growing proportion of neurodiverse children attended the pain clinic. Neurodiverse children presented with more severely impactful pain, they spent a longer duration of time within the pain clinic and were less likely to be discharged due to pain improvement. {middle dot} How this study might affect research, practice or policy: Identifying neurodiverse children as a patient group with distinct requirements may prompt adaptations in chronic pain management practices. This audit provides an initial framework for subsequent research.

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Understanding problems and solutions related to accessing cervical screening for people with a physical disability, condition, impairment or difference

Kemp, E.; Sim, J.; Wright-Bevans, K.; Renke, S.; Chew-Graham, C. A.; Finney, A.; Harper, C.; Marlow, L. A.; Sherman, S. M.

2026-06-03 primary care research 10.64898/2026.05.27.26354052 medRxiv
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Background Physically Disabled women are less likely to access cervical screening than non-disabled women, yet little research has been conducted to understand the problems that Disabled women face or potential solutions. Methods A cross-sectional online survey was conducted with 1493 UK-based participants who identified as having a physical disability, impairment, condition, or difference that makes cervical screening difficult or impossible. Participants were presented with statements about cervical screening problems and potential solutions and asked to indicate agreement using a 5-point scale. They also provided open-ended comments. Data were analysed using descriptive statistics, multinomial logistic regression and thematic analysis. Results More than half of participants reported delaying/missing (46.8%) or never attending (8.8%) screening, with most of those (71.0% and 81.4% respectively) indicating that the main reason was disability-related factors. The highest levels of agreement for problems were for concerns about pain, embarrassment, and fear of what the test might find and for potential solutions were for having a doctor or nurse who is willing to try different solutions, discusses specific needs, and understands physical disability. Never-attendance (OR = 0.022, 95% CI 0.014, 0.035) and delaying or missing appointments, (OR = 0.057, 95% CI 0.043, 0.076) negatively predicted future screening attendance. Six themes were identified from open-ended comments, supporting and extending the quantitative findings. Conclusion Disabled women face the same problems related to cervical screening as non-disabled women and additionally face disability-specific problems. Cervical sample taker training should incorporate ways to support physically Disabled women to have equitable access to screening.

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Study protocol for preoperative classification using integrated screening and short-course neoadjuvant BRAF/MEK inhibition in newly diagnosed papillary craniopharyngioma (the PRECISE-PCP study): a prospective single-arm study

Ye, Z.; Wu, G.; Jiang, H.; Gu, X.; Huang, R.; Wang, Y.; Qiao, N.; Ma, Z.; Ye, Z.; Wu, Y.; Wang, W.; Cheng, H.; Chen, H.; Ye, H.; Wang, Y.; Zhang, Z.; Guan, M.; Zhao, Y.; Zhang, Q.

2026-05-12 oncology 10.64898/2026.05.08.26351826 medRxiv
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IntroductionCraniopharyngioma (CP) comprises two distinct histological subtypes, adamantinomatous craniopharyngioma (ACP) and papillary craniopharyngioma (PCP), which are often challenging to distinguish preoperatively. Approximately 95% of PCP harbor the BRAF V600E mutation, whereas ACP lacks this alteration, making PCP uniquely sensitive to BRAF and MEK inhibition. However, in the absence of a reliable preoperative classification strategy, targeted therapy has been limited to recurrent disease or to cases with histological confirmation. This study aims to describe and prospectively evaluate a pragmatic preoperative classification strategy and short-course neoadjuvant BRAF and MEK inhibition followed by surgery in newly diagnosed, preoperatively classified PCP. Methods and analysisThis is a prospective, single-arm, open-label study. Patients with newly diagnosed craniopharyngioma will be screened using an integrated preoperative strategy combining imaging-based prediction and selective cerebrospinal fluid (CSF) cell-free DNA testing for BRAF V600E in indeterminate cases. Twelve participants preoperatively predicted as PCP and BRAF V600E positive will receive dabrafenib 150 mg twice daily plus trametinib 2 mg once daily for up to three 28-day cycles, followed by transnasal endoscopic surgery. Assessments are scheduled at days 7, 14, 28, 56, and 84 until surgery. The primary endpoint is objective response rate, assessed by contrast-enhanced MRI using RANO 2.0 criteria. Secondary outcomes include progression-free survival, local disease control, endocrine outcomes of the hypothalamic-pituitary-adrenal and hypothalamic-pituitary-thyroid axes, visual and cognitive outcomes, postoperative diabetes insipidus, surgical complexity, and concordance between the preoperative classification strategy and postoperative pathology and BRAF V600E status. Exploratory analyses will evaluate treatment-related changes in tumor vascularity, tissue characteristics, and post-treatment molecular alterations in tumor tissue. Ethics and disseminationThis protocol has been approved by the Ethics Committee of Huashan Hospital, Fudan University (KY2024-028). Written informed consent will be obtained from all participants. Results will be disseminated through peer-reviewed publications and scientific conferences. Trial registration numberChiCTR2400081636 STRENGTHS AND LIMITATIONS OF THIS STUDYO_ST_ABSStrengthC_ST_ABS[tpltrtarr] This study proposes an integrated, clinically applicable preoperative strategy that combines imaging-based prediction with selective cerebrospinal fluid cell-free DNA analysis to identify papillary craniopharyngioma (PCP) prior to surgery. [tpltrtarr]It prospectively evaluates short-course neoadjuvant BRAF and MEK inhibition in newly diagnosed PCP, addressing a clinically relevant gap in current management. [tpltrtarr]Standardized, multidimensional assessments are performed across the neoadjuvant, perioperative, and early postoperative periods, capturing radiographic, surgical, endocrine, visual, and cognitive outcomes. Limitation[tpltrtarr] The single-arm, open-label design without a surgical control group limits direct comparison with upfront surgery. [tpltrtarr]Despite the integrated prediction strategy, preoperative misclassification cannot be excluded entirely.

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Adherence to data-sharing policies - a comparison of the BMJ with other major medical journals

Avenell, A.; Bishop, D.

2026-05-21 medical ethics 10.64898/2026.05.15.26353284 medRxiv
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Background: In 2024, the BMJ updated its data-sharing policy for clinical trials, requiring deidentified individual patient data (IPD) to be openly deposited prior to publication. Our objective was to discover if data-sharing increased after introduction of the new policy. Method: All data-sharing statements were downloaded from BMJ trials published in 2023 (submitted pre-updated policy) and 2025 (submitted post-updated policy). Data for 2025 were gathered for trials in five comparison medical journals. Data-sharing statements were coded to specify whether IPD were immediately available, and if not, the reason why. Where a statement gave a link to a repository, we checked whether data were available. Results: Openly available IPD for BMJ trials increased from 0/32 prior to the new policy to 19/33 (58%) after the updated policy; seven articles gave repository links that did not yield any data. In the five comparison journals, rates of open IPD varied from 0% to 5.6%. Conclusions: There was a substantial increase in open sharing of IPD after introduction of the new policy compared to a prior period. Open sharing of IPD is possible, but it is unpopular with authors and is unlikely to be achieved without firm editorial enforcement