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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Febbraio 2025

Protocol for a systematic review of economic evaluations considering costs and health outcomes of weather and climate-related extreme events in humans

Background
Extreme weather and climate-related events are increasing in frequency and intensity, which pose substantial human casualties and economic losses. The healthcare and health-determining sectors require information about how extreme weather events affect the population’s health, healthcare and other sectors’ capacities to prepare for and manage these events and their aftermath. We aim to conduct a systematic review to identify the recent evidence on the costs and health outcomes of extreme weather events in humans.

Methods and analysis
The Preferred Reporting Items for Systematic Reviews and Meta-Analyses Protocols guidelines were followed for reporting this protocol. A comprehensive search will be conducted using several search engines, for example, PubMed, Scopus and Institute for Scientific Information Web of Science. Peer-reviewed and grey literature published in English that evaluated the health outcomes and costs of extreme climate events will be retrieved without restriction on the publication year or geographical location. Two reviewers will independently assess each study for inclusion. Study quality will be evaluated with the recommended quality assessment tools. Data will be reported using descriptive statistics, graphical plots and a narrative synthesis.

Ethics and dissemination
An ethical assessment was not required. The data generated from the systematic review will be disseminated through peer-reviewed journal articles and international conferences and will inform our original research study.

PROSPERO registration number
This systematic review has been registered at the International Prospective Register of Systematic Reviews (registration ID: CRD42024582635).

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Febbraio 2025

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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Febbraio 2025

Scoping review of happiness and well-being measurement: uses and implications for paediatric surgery in low- and middle-income contexts

Objective
This study aims to map and compare existing methodologies for creating happiness and well-being indices and examine their application to paediatric surgical interventions in low- and middle-income countries (LMICs).

Design
A scoping review methodology was used based on the guidelines published by the Joanna Briggs Institute and the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Extension for Scoping Reviews.

Data sources
Literature was sourced from PubMed, ScienceDirect and Google Scholar, supplemented by references from relevant studies.

Eligibility criteria
Studies were selected based on relevance to LMIC settings, paediatric surgery and well-being or happiness outcomes. Inclusion criteria covered research on paediatric surgical interventions, well-being measures, happiness indices and studies on specific conditions impacting child well-being in LMICs. Exclusions applied to non-English studies, those with unclear methods, undefined well-being concepts, a focus on socioeconomic indices, surgical techniques over outcomes or those published before 2000. Eligible sources included research articles, review articles and technical reports.

Data extraction and synthesis
Two reviewers independently extracted data, including study characteristics, populations, methodologies and key findings. The data were organised in an Excel spreadsheet for clarity and accuracy. A total of 51 sources were initially identified, with 28 included in the final review.

Results
The review revealed a broad range of well-being measurement techniques, from national population-level indices to health-related quality-of-life measures. A key finding was the strong reciprocal relationship between subjective well-being and physical health: subjective well-being impacts health outcomes, while health outcomes influence subjective well-being. However, the lack of standardised methods for assessing well-being postsurgery, particularly in LMICs, leads to inconsistent and fragmented data that complicate resource allocation and comparisons between interventions.

Conclusions
This review highlights the importance of integrating comprehensive well-being measures, particularly subjective assessments, into paediatric surgical contexts within LMICs. Such integration is critical to enhance global health interventions and capture the broader impacts of surgical care on well-being and happiness.

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Febbraio 2025

Roles of physiotherapists in primary care teams: a scoping review

Objectives
We aimed to provide an overview of the existing knowledge regarding the roles of physiotherapists in primary care teams.

Design
Scoping review based on the methodological framework provided by Arksey and O’Malley (2005) and updated by Levac et al (2010).

Data sources and study selection
A search strategy was carried out across the Medline, CINAHL, Academic Search Complete and AMED databases in June 2023. Selected articles, based on qualitative or mixed design studies, had to report on the roles of physiotherapists working in team-based primary care organisations and be published in the last 10 years.

Data extraction and analysis
Data were extracted by one team member and further validated by a second team member. A mixed thematic analysis based on the Competency Profile for Physiotherapists in Canada was used to identify all the roles undertaken by physiotherapists.

Results
The database search yielded 2324 articles. From the 13 included articles, 6 main themes emerged: conduct client assessment for musculoskeletal conditions, participate in health promotion and prevention, promote self-management support, communicate with patients, collaborate with other primary care providers and partners, and provide holistic care.

Conclusions
The review identified a wide variety of roles, primarily related to the treatment of musculoskeletal patients. In primary care settings, interprofessional collaboration can be hindered by a lack of knowledge regarding the roles of physiotherapists. Future studies should aim to develop effective strategies to ensure that all primary care team members have a comprehensive understanding of the roles of physiotherapists and to explore roles associated with non-traditional forms of physiotherapy practice.

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Febbraio 2025

Beneficial and harmful effects of duloxetine versus placebo, 'active placebo or no intervention for adults with major depressive disorder: a systematic review with meta-analysis and trial sequential analysis of randomised clinical trials

Objectives
To assess the beneficial and harmful effects of duloxetine versus ‘active placebo’, placebo or no intervention for adults with major depressive disorder.

Design
Systematic review with meta-analysis and trial sequential analysis of randomised trials.

Data sources
Cochrane Central Register of Controlled Trials, MEDLINE, Embase, PsycINFO and other relevant databases up until January 2023. We requested clinical study reports from 36 competent authorities.

Eligibility criteria for selecting studies
All randomised clinical trials comparing duloxetine versus placebo, ‘active placebo’ or no intervention, irrespective of publication type, publication status, publication year and language for treatment of major depressive disorder in adults.

Data extraction and synthesis
Five authors in pairs extracted data using a standardised data extraction sheet. A third review author was consulted for disagreements. Intervention effects were assessed by both random-effects and fixed-effect model meta-analyses, risk of bias assessments were performed by two independent review authors using Cochrane’s risk of bias tool V.2 and the certainty of evidence was assessed using Grading of Recommendations Assessment, Development and Evaluation.

Results
We included 28 trials randomising a total of 7872 participants. All results were at high risk of bias. The trials’ assessment time points were between 6 and 16 weeks after randomisation. Meta-analyses showed evidence of a beneficial effect of duloxetine on depressive symptoms (mean difference –1.81, Hamilton Depression Rating Scale (HDRS-17) points; 95% CI –2.34 to –1.28; heterogeneity I2=0.0%; 12 trials) and quality of life (mean difference –3.79 points, 95% CI –5.11 to –2.46; I2=0.0%; three trials), but the effect sizes were below our predefined minimal clinically important differences. Trial sequential analysis showed that we did not have enough information to assess the effects of duloxetine on serious adverse events (SAEs) (OR 0.67, 95% CI 0.44 to 1.02; I2=0.0%; 19 trials) or suicide or suicide attempts (OR 1.08, 95% CI 0.37 to 3.16; six trials). Duloxetine increased the risk of non-SAEs (risk ratio 1.27, 95% CI 1.22 to 1.32; I2=73.0%; 24 trials). The adverse events with the lowest number needed to harm (NNH) were nausea (NNH 6), dry mouth (NNH 13), somnolence (NNH 17), withdrawal syndrome (NNH 19), sweating (NNH 20), dizziness (NNH 21) and constipation (NNH 21).

Conclusions
Duloxetine appears to reduce depressive symptom scores and improve quality of life scores in the short term, but the effect sizes are minimal and of questionable patient importance. The short- and long-term effects of duloxetine on risks of SAEs and suicidality are uncertain. Duloxetine increases the risks of several short-term adverse events. Systematic assessments of benefits and harms over longer periods are required.

Trial registration number
PROSPERO 2016 CRD42016053931.

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Febbraio 2025

Interventions for the management of post-COVID-19 condition (long COVID): protocol for a living systematic review and network meta-analysis

Background
Up to 15% of survivors of COVID-19 infection experience long-term health effects, including fatigue, myalgia and impaired cognitive function, termed post-COVID-19 condition or long COVID. Several trials that study the benefits and harms of various interventions to manage long COVID have been published and hundreds more are planned or are ongoing. Trustworthy systematic reviews that clarify the benefits and harms of interventions are critical to promote evidence-based practice.

Objective
To create and maintain a living systematic review and network meta-analysis addressing the benefits and harms of pharmacologic and non-pharmacologic interventions for the treatment and management of long COVID.

Methods
Eligible trials will randomise adults with long COVID to pharmacologic or non-pharmacologic interventions, placebo, sham or usual care. We will identify eligible studies by searching MEDLINE, EMBASE, CINAHL, PsycINFO, AMED and CENTRAL from inception, without language restrictions.
Reviewers will work independently and in duplicate to screen search records, collect data from eligible trials, including trial and patient characteristics and outcomes of interest and assess risk of bias. Our outcomes of interest will include patient-reported fatigue, pain, postexertional malaise, changes in education or employment status, cognitive function, mental health, dyspnoea, quality of life, physical function, recovery and serious adverse events.
For each outcome, when possible, we will perform a frequentist random-effects network meta-analysis. When there are compelling reasons to suspect that certain interventions are only applicable or effective for a subtype of long COVID, we will perform separate network meta-analyses. The Grading of Recommendations, Assessment, Development and Evaluations (GRADE) approach will guide our assessment of the certainty of evidence.
We will update our living review biannually, on the publication of a seminal trial, or when new evidence emerges that may change clinical practice.

Conclusion
This living systematic review and network meta-analysis will provide comprehensive, trustworthy and up-to-date summaries of the evidence addressing the benefits and harms of interventions for the treatment and management of long COVID. We will make our findings available publicly and work with guideline-producing organisations to inform their recommendations.

Ethics and dissemination
The study describes the protocol for a systematic review that uses data from published trial reports. Therefore, the study is exempt from ethics review. We intend to deposit all data in a public repository and publish each iteration of the living review online.

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Febbraio 2025

Beneficiaries satisfaction with health insurance and associated factors in Sub-Saharan Africa: a systematic review and meta-analysis

Objective
Beneficiaries’ satisfaction with health insurance schemes is crucial for the success of these programmes, influencing their effective implementation and reducing dropout rates. This systematic review and meta-analysis aimed to assess the proportion of beneficiaries satisfied with health insurance and identify factors associated with their satisfaction in Sub-Saharan Africa (SSA).

Design
A systematic review and meta-analysis were conducted in accordance with the Preferred Reporting Items for Systematic Review and Meta-analysis guidelines.

Data sources
PubMed/MEDLINE, African Journals Online, Cumulative Index to Nursing & Allied Health Literature and Google Scholar were searched up to 23 May 2024.

Eligibility criteria
Observational and quantitative studies conducted in SSA that reported the proportion of health insurance beneficiaries satisfied with the scheme and/or determined factors associated with satisfaction were included.

Data extraction and synthesis
Data were extracted using Microsoft Excel and analysed with STATA V.17 software. The quality of studies was assessed using Joanna Briggs Institute checklists. A random-effects model was employed to estimate pooled outcomes. Publication bias was evaluated with a funnel plot and Egger’s regression test, while heterogeneity was assessed using the I² statistic.

Result
The study included 29 primary studies with a total of 11,488 participants. Among the included studies, 17 (58.62%) were found to have a low risk of bias, while the remaining studies exhibited a moderate risk of bias. The findings suggested publication bias among the included studies. To address this, a trim-and-fill analysis imputed 10 hypothetical missing studies, resulting in a more symmetrical funnel plot. The pooled finding showed that 61.84% of beneficiaries were satisfied with their health insurance (95% CI: 55.14 to 68.55, (I2=98.6%, p

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Febbraio 2025

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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Febbraio 2025

Annual versus biannual azithromycin mass drug administration for the elimination of infectious trachoma in Africa: protocol for a systematic review and meta-analysis using data from individual communities

Introduction
Trachoma is an infectious eye disease caused by Chlamydia trachomatis and the leading infectious cause of blindness worldwide. WHO recommends community-wide oral azithromycin treatment as part of its trachoma elimination strategy. WHO initially recommended mass drug administration (MDA) with azithromycin once per year for several years, followed by reassessment. However, some districts have failed to eliminate trachoma even after a decade of annual MDA with azithromycin. As a result, WHO has recently advocated for more frequent antibiotics in districts with persistent trachoma. Although no specific frequency of antibiotic distributions has been recommended, several randomised trials have compared annual with biannual mass azithromycin distributions. This review aims to synthesise the available data to assess the effectiveness of biannual azithromycin MDA relative to annual MDA.

Methods and analysis
PubMed, Embase, Web of Science, Scopus and Google Scholar will be searched for studies comparing annual and biannual mass azithromycin distributions for trachoma. Community-level data will be extracted using a standardised data extraction form. Authors will be asked to contribute community-level data not available in the manuscript. The main outcome will be C. trachomatis infection among 1–9-year-old children, expressed as a community-level prevalence. A secondary outcome will be the presence of trachomatous inflammation-follicular. The analysis will follow principles of a one-stage individual participant data meta-analysis using complete case mixed-effects regression models with a random effect for study to model community-level prevalence data. Statistical heterogeneity will be assessed with the I 2 statistic.

Ethics and dissemination
The research will use community-aggregated data and is thus exempt from ethical approval. The results will be submitted for publication in a peer-reviewed journal.

PROSPERO registration number
CRD42024526120.

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Febbraio 2025

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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Febbraio 2025

Association between parity and gravidity & hypertension and blood pressure: protocol for a systematic review and meta-analysis

Introduction
Cardiovascular disease is the leading cause of death among women worldwide, and hypertension is one of the most prevalent and modifiable risk factors. Parity and gravidity, independent of pregnancy complications, have each been associated with hypertension, although results are conflicting. Therefore, we propose to estimate the association between parity and gravidity with hypertension and blood pressure in a systematic review of the literature.

Methods and analysis
A systematic review will be conducted to estimate the association between parity and gravidity and hypertension and blood pressure. Electronic databases (Excerpta Medica Database, Ovid MEDLINE, Cochrane Central Register of Controlled Trials, Cumulative Index to Nursing and Allied Health Literature Plus and Web of Science) will be searched from inception to January 2025. Two investigators will independently screen identified abstracts and select observational cohort studies, case-control studies and randomised controlled trials examining parity or gravidity and hypertension or blood pressure. Extracted data will include study and population characteristics, comorbidities, parity, gravidity, incidence of hypertension and changes in blood pressure, study quality and risk of bias. If there are sufficient data, they will be summarised using random effects meta-analysis to estimate the pooled risk ratio or odds ratio of hypertension. Stratified and subgroup analyses will be used to explore potential sources of heterogeneity.

PROSPERO registration number
CRD42024560535.

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Febbraio 2025

Examining the association between child development and parental mental health after preterm birth-related stress: a systematic review of the literature and meta-analysis protocol

Introduction
Preterm infants born before 32 weeks of gestation are generally admitted to a neonatal intensive care unit (NICU) to receive life-saving treatment, resulting in early exposure to stressful events. Yet, NICU admission is not only stressful for the infant but can also have a long-lasting negative impact on parental mental health, who may worry about their child. Parental mental health problems might affect child development through parental behaviour and the parent–infant relationship. Simultaneously, adverse child development after preterm birth can (further) elevate parental stress and mental health problems, straining parental behaviour, the parent–infant relationship and child development. This systematic review and meta-analysis aims to examine the association between preterm-born children’s development (

Leggi
Febbraio 2025