Effects of manual osteopathic interventions on psychometric and psychophysiological indicators of anxiety, depression and stress in adults: a systematic review and meta-analysis of randomised controlled trials

Objectives
To evaluate whether osteopathic and related manual interventions improve adult mental health (depression, anxiety, stress) and psychophysiological measures (eg, heart rate variability, skin conductance).

Design
Systematic review and meta-analysis of randomised controlled trials (RCTs).

Data sources
PubMed, MEDLINE (Ovid), Scopus, Cochrane, and AMED, searched through September 2024.

Eligibility criteria
English-language RCTs with ≥30 participants investigating osteopathic or related manual therapies (eg, myofascial release, high-velocity low-amplitude thrusts) delivered by qualified practitioners, compared with no treatment or sham, and reporting immediate postintervention mental health or psychophysiological outcomes.

Data extraction and synthesis
Full-text screening, risk-of-bias assessment and data extraction were conducted independently by multiple reviewers using a standardised Joanna Briggs Institute (JBI) Extraction Form. Risk of bias was assessed using the JBI Critical Appraisal Checklist. For meta-analyses, Hedges’ g (with 95% CIs) was calculated from postintervention means and SD. Random-effects models accounted for heterogeneity, and prediction intervals were calculated to assess uncertainty in effect estimates.

Results
20 RCTs were included. Osteopathic interventions reduced depression (Hedges’ g=–0.47, 95% CI: –0.86 to –0.09, p=0.02) and increased skin conductance (Hedges’ g=0.67, 95% CI: 0.00 to 1.34, p=0.05). Depression improvements were greater in pain populations (Hedges’ g=–0.61, 95% CI: –1.06 to –0.17, p=0.01). However, wide prediction intervals and moderate heterogeneity indicate uncertainty in true effect sizes, and limited studies and sample sizes restrict assessment of publication bias.

Conclusions
Osteopathic and related manual therapies may reduce depression and influence certain psychophysiological markers, particularly in pain populations, but uncertainty and heterogeneity limit confidence. More rigorous, larger, and longitudinal RCTs are needed.

Trial registration number
This meta-analysis was not formally registered, though the protocol and search strategy can be found at Open Science Framework, registration identification: https://osf.io/jrtpx/.

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Establishing primary care physician commitment in Canadian long-term care homes: a protocol for a modified e-Delphi study

Introduction
The delivery of medical services by primary care physicians (PCPs) in long-term care (LTC) homes lacks consistency. There is no Canadian standard for PCP commitment in the LTC home setting, which can influence the quality of care delivered and resident health outcomes. The PCP’s commitment to LTC practice is theorised as the proportion of a physician’s practice dedicated to LTC, the number of residents for whom they provide care and the time spent on individual resident encounters. We aim to establish consensus on expectations concerning PCP commitment in Canadian LTC homes.

Methods and analysis
We describe a protocol for a two-round modified e-Delphi study assessing the consensus of an expert panel, guided by the RAND methodological guidance for conducting Delphi panels and the ACcurate COnsensus Reporting Document (ACCORD) guideline for healthcare-based consensus studies. We will recruit pan-Canadian experts who demonstrate extensive knowledge and experience in medical care delivery and medical practice models in the Canadian LTC sector. A literature review will generate a candidate list of statements constituting PCP commitment. The first round evaluates the relevance and feasibility of candidate statements through an online questionnaire. Panellists may also write open-ended, qualitative responses to add rationales, suggest alternatives and share new ideas. We will then host a virtual synchronous meeting to have an in-depth discussion about the results from round one. A second questionnaire will be distributed to evaluate the remaining statements that have not reached consensus, and any new statements added based on the same criteria.

Ethics and dissemination
The Hamilton Integrated Research Ethics Board (Project ID #17321) approved our study. The findings will be disseminated through manuscripts, presentations, and the lead author’s thesis.

Trial registration number
The ISRCTN Registry: #35125526.

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Midwives knowledge and perspectives on neonatal resuscitation and survival before and after Helping Babies Breathe training: a qualitative study in Uganda

Objectives
Birth asphyxia is a significant factor contributing to neonatal mortality, particularly in low- and middle-income countries where most neonatal deaths occur. Encouraging women to deliver in hospitals has become a pivotal strategy. Numerous training programmes, such as Helping Babies Breathe (HBB), have been designed to impart neonatal resuscitation and infant care skills to support breathing at birth. Limited attention has been given to exploring the perspectives and experiences of midwives and their hospital managers in translating the acquired knowledge from these programmes into practice. This study aims to explores the understanding, perspectives, and first-hand experiences related to the factors impacting neonatal resuscitation practices and survival, both pre-HBB and post-HBB training.

Design
Qualitative individual interviews and focus group discussions study. A data-driven inductive content analysis approach was used for the analysis.

Setting
The high-risk labour ward and theatre at a National Referral Hospital, Uganda.

Participants
45 clinically active midwives were enrolled; all had recently completed the HBB training programme.

Intervention
Semistructured individual interviews (n=2) and focus group discussions (n=43, distributed across seven groups) were held from 26 April to 4 May 2018. Discussions were audio-recorded and transcribed verbatim.

Results
Three emerging themes illustrated midwives’ knowledge, opinion on and experience of neonatal resuscitation and survival. Excessive workload, limited access to clean equipment, and ethical dilemmas hampered performance and neonatal survival. Midwives, facing inadequate support, strived to ensure patient safety. While HBB training addresses malpractices, additional training was needed.

Conclusions
Midwives had few opportunities to change their workload and improve their education. This highlights the need for a closer examination of the challenges faced by healthcare providers in ensuring effective neonatal resuscitation and survival in low-resource settings. To address this, we propose better routines for organising work, cleaning and maintaining equipment, and implementing better training routines.

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Family-focused intervention programme to foster adolescent mental health and well-being: protocol for a multicountry cluster randomised factorial trial (FLOURISH Phase 2)

Introduction
Adolescent mental health problems represent a significant global health issue, particularly in low- and middle-income countries, such as the Republic of North Macedonia and the Republic of Moldova. Effective and scalable interventions are urgently needed to address these challenges.

Methods and analysis
This protocol outlines a multicountry cluster randomised factorial trial, implemented according to the multiphase optimisation strategy (Phase 2), which evaluates the effectiveness and costs of three add-on components for the Parenting for Lifelong Health for Parents and Teens programme: adolescent mental health tools based on UNICEFs Helping Adolescents Thrive comics, adolescent peer support based on UNICEFs ‘I Support My Friends’ intervention and engagement booster designed to enhance attendance and programme completion through incentives. The study will recruit 720 families and involve 64 clusters in North Macedonia and Moldova. Primary outcomes will include adolescent internalising problems and social support, family functioning and attendance during the programme. Secondary outcomes will assess broader aspects of mental health among caregivers and adolescents, as well as implementation and cost outcomes. Data will be collected at baseline and postintervention, approximately, 8 weeks later. Statistical analyses will include regression models to assess the main and interaction effects of the intervention components and cost analyses.

Ethics and dissemination
The study received ethical approval from the University of Klagenfurt in Austria (approval number: 2023–013), the Medical Faculty at St. Cyril and Methodius University in North Macedonia (approval number: 03-2144/4) and the National Committee of Ethical Expertise for Clinical Trials in Moldova (approval number: 1476). The results will be disseminated through peer-reviewed journals, conferences, webinars in multiple languages, regional forums, stakeholder meetings with policymakers and practitioners, public communication through media engagement and open access platforms, including data sharing and early release of findings.

Trial registration details
Trial registration: NCT06562244; Project page: https://www.flourish-study.org/about.html

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Phase I trial on the safety of olprinone for low central venous pressure management aimed at haemorrhage control during open and laparoscopic hepatectomy: a study protocol

Introduction
Hepatectomy is the primary treatment for malignant liver tumours. It is crucial to control bleeding during liver parenchymal transection. Methods to reduce central venous pressure (CVP), such as fluid restriction and the use of vasodilators, are essential for minimising bleeding but can lead to haemodynamic instability. Phosphodiesterase-3 (PDEIII) inhibitors such as milrinone have shown efficacy in managing low CVP and maintaining haemodynamic stability. This study investigates olprinone, another PDEIII inhibitor with a potentially strong vasodilatory effect, for its safety and efficacy in CVP management during hepatectomy.

Methods and analysis
This single-centre phase I trial at Shizuoka Cancer Center evaluates the intraoperative administration of olprinone for open and laparoscopic hepatectomy. The trial employs a 3+3 cohort study design to determine the maximum tolerated dose (MTD) and identify dose-limiting toxicities. The study also assesses the trends in CVP and circulatory dynamics using the FloTrac System, alongside safety evaluations. The trial aims to establish the safety and MTD of olprinone during hepatectomy, potentially offering a method to control CVP without causing haemodynamic instability. This could lead to reduced blood loss, shorter operative time and fewer postoperative complications.

Ethics and dissemination
The study protocol was approved by the Certified Review Board of Shizuoka Cancer Center (approval number CRB4180010).

Trial registration number
jRCTs041230110 and jRCTs041230111.

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Time-dynamic associations between symptom-related expectations, self-management experiences and somatic symptom severity in everyday life: an ecological momentary assessment study with university students

Objective
The present study investigated the associations between symptom-related expectations, self-management experiences and expectation framing on somatic symptom severity in university students in two conditions (positive or standard expectation framing). We hypothesised that symptom-related expectations are significantly associated with concurrent and subsequent levels of somatic symptom depending on expectation framing.

Design
A smartphone-based micro-longitudinal ecological momentary assessment study with randomisation to one of two expectation framing groups (positive vs negative) was carried out. Multilevel mixed-effects linear regression analyses were conducted for data analysis.

Setting
Data was collected in real-time from university students via smartphones, with three predetermined assessments per day over seven consecutive days.

Participants
A total of 104 students (63.5% male, 0% diverse) who were 18 years or older, possessing sufficient German language skills and had access to an Android-powered smartphone were included.

Interventions
Participants were randomised to one of two different expectation framing groups, either receiving questionnaires for the expected impairment due to somatic symptoms (negative framing) or for the expected freedom from impairment due to somatic symptoms (positive framing).

Primary outcome measures
Somatic symptom severity was assessed using an adapted version of the Patient Health Questionnaire, with 11-point instead of 3-point Likert-scales. Symptom-related expectations were assessed using 11-point Numerical Rating Scales and self-management experiences were assessed using binary variables.

Results
Concurrent analysis revealed a significant association between symptom-related expectations and symptom severity (β=0.934, p

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Trial protocol of an open-label pilot study of oral naltrexone-bupropion combination pharmacotherapy for the treatment of methamphetamine use disorder (the NABU trial)

Introduction
Methamphetamine use disorder is a global public health concern with no approved pharmacotherapies for its treatment. One recent randomised controlled trial conducted in the USA examined a combination of bupropion and naltrexone not readily available globally. Here, we report a trial protocol for an oral formulation of combined naltrexone and bupropion.

Methods and analysis
This single-arm, open-label pilot study will assess the safety and feasibility of oral naltrexone and bupropion (40 mg/450 mg daily in divided doses) in adults with methamphetamine use disorder. Participants (n=20) will be outpatients of a stimulant treatment program at an inner-city hospital in Sydney, Australia. The primary endpoint is Day 84. Participants will attend weekly study visits from Baseline to Week 12 and a follow-up telephone visit at Week 16. All participants will receive treatment as usual, such as psychosocial therapy. Primary outcomes are safety (measured by treatment-emergent adverse events (AEs)/adverse reactions) and feasibility (measured by the time taken to recruit, the proportion of ineligible participants, retention in the study and study medication adherence). Secondary outcomes will assess methamphetamine use, craving and withdrawal; treatment goals and expectations; physical and psychological well-being; depression and anxiety; and treatment satisfaction. Qualitative interviews will assess the acceptability of the intervention and outcome measures.

Ethics and dissemination
This study received ethics approval from the St Vincent’s Hospital Human Research Ethics Committee (2023/ETH00549). Results will be submitted to peer-reviewed journals and scientific conferences, and a video abstract will be created to ensure that the findings are accessible to participants and people who use methamphetamines.

Trial registration number
ANZCTR: ACTRN12623000866606 (protocol V.2.1 dated 08 April 2024).

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Trends in the utilisation of maternal and child healthcare services from the public and private health sectors in India, 2005-2021: an analysis of cross-sectional survey data

Objectives
To estimate the levels and trends of maternal and child healthcare (MCH) service utilisation in India across subsidised and unsubsidised health sectors and to explore total market approach to identify geographies where the private sector has potential to improve MCH services in India.

Design and setting
This study used three recent rounds of the National Family Health Survey (NFHS), a cross-sectional survey in India, conducted in 2005–2006, 2015–2016 and 2019–2021. Bivariate analysis and multinomial logistic regression were used to estimate the utilisation of key MCH indicators from subsidised and unsubsidised health sectors. Market sustainability of key MCH indicators was assessed by level of MCH services and subsidisation.

Participants
36 850, 190 898 and 176 843 ever-married women aged 15–49 years, 4440, 22 500 and 15 334 children under 5 years of age with diarrhoea before the survey, and 2552, 6960 and 6117 children with symptoms of acute respiratory infections (ARI) in NFHS 2005–2006, 2015–2016 and 2019–2021, respectively.

Outcome measures
The study used three maternal healthcare indicators: women had four or more antenatal care (ANC) visits, had institutional delivery, and received postnatal care (PNC); and two child healthcare indicators: care seeking for ARI and diarrhoea.

Results
In India, utilisation of maternal healthcare services increased over the last 15 years: four or more ANC visits increased from 37% to 58% and PNC of mothers increased from 33% to 78% between 2005–2006 and 2019–2021. The results of the multivariate analysis showed that utilisation of ANC (67% from public vs 18% from private health facilities), institutional delivery (64% from public vs 25% from private health facilities) and PNC (73% from public vs 27% from private health facilities) was significantly higher (p

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How do serum cytokine levels change in myocarditis and inflammatory dilated cardiomyopathy relative to healthy individuals? A protocol for a systematic review and meta-analysis

Introduction
Myocarditis is an inflammatory heart disease resulting from infections, toxic exposures or autoimmune reactions. Irrespective of the factors responsible for this disease, cytokines play an important role in regulating the immunological response involved in its development and progression. Accordingly, this protocol aims to conduct a systematic review and meta-analysis summarising previous research on serum and plasma levels of cytokines in patients with myocarditis and inflammatory dilated cardiomyopathy.

Methods and analysis
Four scientific databases: PubMed, Embase, Scopus and Web of Science, will be searched. The estimated date of the search will be 30 March 2024. Each stage of the review, including the study selection, data extraction, risk of bias and quality of evidence assessments, will be performed in duplicate. Studies meeting the following criteria will be eligible for inclusion: (1) studies involving ‘myocarditis’ or ‘inflammatory dilated cardiomyopathy’ and (2) studies are required to report serum levels of any cytokine. Meta-analyses will be used to summarise serum levels of each cytokine if possible. Subgroup analysis will be stratified by age, sex, sample size, New York Heart Association scale, cardiac Troponin T, N-terminal prohormone of brain natriuretic peptide, C reactive protein, number of lymphocytes per mm2 in the endomyocardial biopsy.

Ethics approval and dissemination
This study does not require ethics approval. After completion, the results will be published in a peer-reviewed paper. Data generated during the study will be published in an open access repository.

PROSPERO registration number
CRD42024519625

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Integrated malaria vector control strategies and their effectiveness in sub-Saharan Africa: a systematic review protocol for interventional studies

Introduction
Sub-Saharan Africa has the highest malaria burden in the world. Several vector control strategies are being implemented to reduce mosquito density and protect the most vulnerable populations, such as children under 5 and pregnant women. This systematic review is designed to assess the effectiveness of integrated vector control versus single vector control interventions on malaria incidence and prevalence to guide decisions on controlling malaria vectors in sub-Saharan Africa.

Methods and analyses
We will systematically retrieve published and grey literature from electronic databases and clinical trial registries. The Preferred Reporting Items for Systematic Reviews and Meta-Analysis guidelines will guide us in applying a systematic approach to screening, reviewing and extracting data. An inclusion criterion will be used to independently assess full-text copies of potentially relevant articles by two review authors. Risk of bias will be assessed using the Cochrane Risk of Bias Tool V.2 for randomised controlled trials and the ROBINS-I (Risk Of Bias In Non-randomised Studies – of Interventions) tool for non-randomised intervention studies. A meta-analysis will be conducted based on studies that have reported a high level of evidence (risk ratios or ORs with 95% CIs). If substantial heterogeneity is encountered, subgroup analyses will be explored.

Ethics and dissemination
This review does not require ethical approval. The findings will be shared through open-access publications in peer-reviewed journals and presentations to stakeholders and international policymakers for malaria control.

PROSPERO registration number
CRD42024559088.

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Evidence-informed language: interpretation and impact on intentions to treat – results of an online survey of medical students and specialists in German-speaking countries

Objectives
Currently, there is no generally accepted consensus on how to translate strength of evidence into language. Against this background, we here investigated how widely used verbal descriptors of evidence grades and clinical practice recommendations, respectively, are understood, interpreted and transferred into intentions to treat. We explored differences between medical specialists and undergraduate medical students.

Design
Cross-sectional, anonymous online survey. Assessment was based on publicly available proposals for wording to characterise strength of evidence from randomised versus non-randomised trials and of clinical practice recommendations, respectively.

Setting
The online survey was conducted between September 2021 and March 2022 and promoted by several professional organisations in German-speaking European countries (Germany, Austria and Switzerland).

Participants
Medical students, trainees and medical specialist (open to all medical specialties).

Outcome
The survey was composed of two sections: (1) Aim of the first survey section was to assess if the linguistic differentiation between results from randomised versus non-randomised studies is correctly understood as put forward by the proponents. To this end, participants were asked to grade the relative weight of the expression for the results of a randomised trial versus two proposals for how to express the results of non-randomised studies. (2) Next, strong positive, weak positive, weak negative and strong negative clinical recommendations were presented, and participants were asked to answer in a forced-choice format if they would treat all/no patients, selected patients or only consider treatment. Additionally, the number of eligible patients who would be treated was assessed.

Results
N=1081 physicians and N=539 medical students completed the survey. (1) Less than half of the participants (48.5%) interpreted use of ‘associated with’ as linguistic differentiation between results from randomised versus non-randomised trials in a sense as put forward by the proponents. However, use of the subjunctive mood (‘could’) resulted in 87.3% correct differentiations. (2) Even with only four types of clinical practice recommendations (positive/negative and strong/weak), interpretation and translation into intention to treat, respectively, showed a heterogeneous picture: while the presentation of a strong clinical recommendation led to largely congruent responses, the interpretation of weak recommendations showed a high variability, with no clear response pattern for intentions to treat. Responses from physicians and medical students were largely comparable.

Conclusion
This study demonstrates limitations in the currently used linguistic expressions of strength of evidence and clinical practice recommendations and supports the need to prospectively test effects of language on intentions to treat prior to implementation of a certain wording. Study results cast doubt on that linguistic means alone will lead to optimally targeted intentions to treat.

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Sex-based differences in prescribed medications, surgical procedures and disease-related complications in IBD

Danese et al1 emphasise the urgency to implement advanced combination treatments (ACTs) for inflammatory bowel disease (IBD), suggesting that ACTs may be particularly effective in certain patient populations. In this context, sex as a biological variable is paramount to consider, but remains understudied in all aspects of research reporting and analyses (referred to as ‘sex-aware’ analyses2), and represents an essential element when evaluating disease prevention, intervention(s) and precision medicine. This is especially applicable to IBD since increasing evidence supports sex-based differences, including response to treatment(s), between male and female patients living with Crohn’s disease (CD) or ulcerative colitis (UC),3 4 yet specific studies to date are sparse. To this end, we sought to determine the current state of sex disparities in prescribed medications, surgical interventions and disease-related complications in IBD. Using the TriNetX platform, which allows real-time access to deidentified electronic…

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An investigator-blinded, 24-month, parallel-group, non-inferiority study to compare aesthetic restorations in primary anterior teeth in a paediatric dental clinic: study protocol for a randomised controlled trial

Introduction
Children who suffer from severe caries in childhood may have negative impacts on the growth, development, nutritional problems and quality-of-life problems related to the oral health of the child and their family. There are no studies that have compared rehabilitative techniques of primary anterior teeth regarding patient-centred outcomes and even longevity of the restoration. Thus, this project aims to evaluate the effectiveness of restorative treatment of anterior primary teeth with monochromatic composite resin in single insertion through polyvinyl crowns, after selective removal of carious tissue compared with the effectiveness of conventional restoration.

Methods and analysis
This study proposes to conduct a randomised clinical trial, composed of a sample of 194 deciduous central and lateral incisors with active cavitated lesions, simplified International Caries Detection and Assessment System (ICDAS) C+ score (active and extensive stage caries: ICDAS 5 and 6), with involvement of more than two surfaces. This sample will be divided into two experimental groups, both with selective removal of carious tissue: a group in which conventional restoration will be performed using opaque resins, and another group with monochrome resin with chameleon effect and polyvinyl crowns. The explanatory variables—gender, age, toothbrushing, use of fluoridated toothpaste and dental floss, and socioeconomic status—will be collected through a questionnaire with open questions. The progression of caries lesions after 24 months of follow-up will be considered as the primary outcome. Secondary outcomes will include tooth survival, longevity of restoration, quality of life, perception and satisfaction of the participants’ parents/guardians.

Ethics and dissemination
This protocol has been approved by the Human Research Ethics Committee of Universidade Metropolitana de Santos (protocol number: 6.019.297. Approved 24 April 2023). Results will be submitted to international peer-reviewed journals and presented at international conferences.

Trial registration number
NCT05875064.

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What are the lived healthcare experiences of patients with primary sclerosing cholangitis? A community-based qualitative interview study

Objectives
Primary sclerosing cholangitis (PSC) is a rare chronic disease that presents challenges to both patients and clinicians. This study aimed to explore the experiences of patients with PSC regarding their disease and healthcare.

Design
A series of semi-structured interviews was completed with patients with PSC, including questioning their experiences of living with PSC and its related healthcare.

Setting
Participants were recruited from communities in England, Scotland and Wales, with advertisement via PSC Support (UK disease-specific charity support group).

Participants
18 patients aged between 21 and 72 years were interviewed; 10 were male (56%), and all were of Caucasian ethnicity. Inclusion criteria were as follows: adults, self-identifying as having a diagnosis of PSC, and currently under National Health Service treatment for this disease. Patients with a history of liver transplantation were excluded.

Results
Participants confirmed the ongoing physical and psychological burden of PSC and its related healthcare. Living with PSC was described as a journey; the timeline of events was important to patients, with particular challenges identified along the way. These included difficulties in obtaining a diagnosis and accessing timely and knowledgeable medical care. Overcoming the unusual combination of uncertainties that PSC presents was of particular concern to participants; these differ from those observed in more common chronic diseases with established treatment pathways. Hidden complexities within chronic illness behaviour in PSC were described, including a noteworthy fragile doctor–patient relationship and dependence on the specialist. These produce additional challenges for the optimal clinical management of such patients by generalists and specialists.

Conclusions
This study complements the existing literature on the ongoing high burden of PSC, with added value from in-depth discussions with patients themselves. Priorities for further work have been identified, including the need for improved risk stratification tools to allow individualised management and prognostication, as well as improving access to knowledgeable care while maintaining a strong doctor–patient relationship.

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Multicentre, 26-week, open-label phase 2 trial of the JAK inhibitor filgotinib in Behcets disease, idiopathic inflammatory myopathies and IgG4-related disease: DRIMID study protocol

Introduction
Research into novel therapies for rare, immune-mediated inflammatory diseases (IMIDs) faces significant challenges, including small patient populations, complex clinical trial design and difficulties in patient recruitment. Patients with Behcet’s disease (BD), idiopathic inflammatory myopathies (IIM) and IgG4-related disease (IgG4-RD) typically undergo treatment involving prolonged administration of high-dose glucocorticoids and immunosuppressants. Both are associated with an increased risk of infection. Additionally, glucocorticoids carry long-term toxicity risks. Thus, there is an urgent need to develop more targeted and effective anti-inflammatory treatments. Given the activation of the type 1 interferon pathway in BD, IIM and IgG4-RD, inhibition of the Janus kinase (JAK) STAT pathway emerges as a promising therapeutic strategy. The Drug Rediscovery in IMIDs (DRIMID) consortium aims to conduct a prospective pilot basket trial to investigate the effects of filgotinib, a JAK1 preferential inhibitor approved for ulcerative colitis and rheumatoid arthritis, on disease activity, quality of life and safety in patients with refractory BD, IIM and IgG4-RD.

Methods and analysis
In this investigator-initiated, multicentre, open-label phase 2 study, up to 60 patients with rare IMIDs will be enrolled for a 26-week treatment period with filgotinib 200 mg once daily. The trial consists of two stages, each involving a consecutively treated cohort of up to 20 patients per disease. An interim analysis is conducted between these stages, where the trial will proceed only in diseases showing potential effectiveness. Baseline, 3-month and 6-month assessments will include data on quality of life, disease activity, corticosteroid toxicity and biomarkers. The coprimary endpoints are disease activity and quality of life across and within each disease.

Ethics and dissemination
The study received approval from the Medical Research Ethics Committee in Utrecht, Netherlands. A Data Safety Monitoring Board has been established to monitor the trial’s safety and progress.

Trial registration number
NCT06285539.

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Nutritional interventions to prevent and reduce overweight and obesity during postacute stroke rehabilitation: a scoping review protocol

Introduction
Individuals with stroke are at risk of long-term overweight and obesity due to biopsychosocial factors. Being overweight and obese is associated with an increased risk of numerous chronic conditions, including recurrent stroke. Unfortunately, recommendations for nutritional interventions vary. The objective of this scoping review is to identify and map the body of literature on professional nutritional interventions aimed at preventing or reducing overweight and obesity during postacute stroke rehabilitation.

Methods and analysis
The review follows the Joanna Briggs Institute methodology for scoping reviews. A three-step librarian-assisted search strategy will be conducted using the bibliographic databases MEDLINE (PubMed), Embase, CINAHL and Web of Science. Indexed and grey literature in English and Scandinavian languages, from January 2010 to the present, will be considered for inclusion. The scoping review will include materials such as research articles, methodological papers and clinical guidelines that report on nutritional interventions aimed at preventing or reducing overweight and obesity among individuals with stroke (aged ≥18 years) from admission to rehabilitation hospitals. We will map and identify any kind of nutritional intervention in rehabilitation hospitals, nursing homes or their own environments in high-income countries. Two independent reviewers will conduct an iterative process for screening the identified literature, paper selection and data extraction. Disagreements will be resolved through discussion or with an additional reviewer. A data extraction form will be used to guide the data extraction.

Ethics and dissemination
This review will involve the collection and analysis of secondary sources that have been published and/or are publicly available. Therefore, ethical approval is not required. The results will be published in an international peer-reviewed journal, presented at scientific conferences and disseminated through digital science communication platforms.

Trial registration number
The protocol is registered in the Open Science Framework: https://osf.io/ga63n/view_only=ee07beace7bb48d6b9c82cbf79cf2e95.

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