Frequency, demographics, diagnoses and consultation patterns associated with low-acuity attendances in German emergency departments: a retrospective routine healthcare data analysis from the INDEED project

Objective
Evidence suggests interventions targeting low-acuity attendances have been hampered by insufficient characterisation of potential target groups. This study aimed to estimate the frequency of low-acuity emergency department (ED) attendances and to provide an overview of their demographic, diagnosis and consultation patterns.

Design
Observational analyses of routine healthcare data.

Setting
German EDs.

Participants
Adult patients with statutory health insurance who visited the ED of 16 participating hospitals in 2016.

Main outcome measures
Frequency, demographics, diagnoses and consultation patterns of low-acuity and high-acuity attendees.

Main results
Of the 454 747 ED visits, 370 756 visits (50.1% female) were included for analysis. Four participating hospitals had to be excluded due to the lack of data that were necessary for the stepwise approach to define low and high acuity. We identified 101 337 visits as low acuity (27.3%) and 256 876 as high acuity (69.3%), whereas 12 543 (3.4%) could not be classified. The proportion of attendees classified as low acuity decreased with age (highest at 40.6% in the age group

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Dicembre 2024

Effects of traditional Chinese medicine massage therapy on pain, functional activity, muscle activation patterns and proprioception in knee osteoarthritis: a randomised controlled trial protocol

Introduction
Health education, weight control and exercise therapy are recognised treatment options for the non-surgical management of knee osteoarthritis (KOA); however, the pain and muscle fatigue associated with exercise make it difficult for patients to initially adhere. Traditional Chinese medicine (TCM) massage is an important complementary and alternative therapy that can effectively address these deficiencies. According to TCM theory and preliminary clinical practice, loosening of the muscles while pointing to acupoints can promote the recovery of KOA. Therefore, we hypothesised that exercise therapy in conjunction with TCM massage may lead to more satisfactory results in terms of pain management, active functional muscle activation patterns and proprioception in patients with KOA.

Methods and analysis
A parallel, single-centre, randomised controlled trial involving 106 patients will be conducted at Shuguang Hospital, Shanghai University of Traditional Chinese Medicine. Eligible patients with KOA who agree to participate will be randomised via a 1:1 randomisation system into the experimental group (receiving TCM massage and exercise treatment) and the control group (receiving exercise treatment). The primary endpoint is the change in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) for pain from baseline to 24 weeks. Secondary outcomes include knee function (measured using the WOMAC stiffness and WOMAC functional subscale questionnaire and the timed ‘Up and Go’ test), muscle activation states (evaluated with electromyography techniques), knee proprioception and treatment satisfaction, adherence, safety evaluation and other relevant factors. Outcome assessors and data analysts will be blinded to the allocations, and the participants will not disclose their specific allocations. Outcome analyses will be conducted on both intention-to-treat and per-protocol populations. A preliminary analysis will test whether TCM massage, in addition to exercise, has statistically better outcomes.

Ethics and dissemination
The study protocol has received approval from the Ethics Committee of Shuguang Hospital, Shanghai University of Traditional Chinese Medicine (2023-1357-124-01).
All study participants will be required to give written informed consent. The findings of the study will be submitted to a peer-reviewed journal for publication and presented at scientific conferences. Additionally, the participants will receive copies of the results.

Trial registration number
ChiCTR2300077308.

Leggi
Dicembre 2024

Effect of different modes of administration of esketamine combined with supraclavicular brachial plexus block on the incidence of rebound pain after upper limb fracture surgery: study protocol for a single-centre, double-blinded, randomised controlled trial

Background
Supraclavicular brachial plexus block (SCB) is a common regional analgesic technique for upper limb fracture surgery, but it often leads to rebound pain. Our primary aim is to determine whether different administration methods of esketamine can reduce rebound pain in patients undergoing SCB for upper limb fracture surgery.

Methods/design
This study is designed as a single-centre, double-blinded, prospective, randomised controlled trial. Patients undergoing upper limb fracture surgery, who plan to use a tourniquet, aged 18–60 years, with a body mass index of 18–30 kg/m2 and an American Society of Anaesthesiologists classification of I–III will be randomised into three groups after providing written informed consent: group N (perineural esketamine/ropivacaine); group V (intravenous esketamine/perineural ropivacaine); and group C (perineural ropivacaine). The primary outcome will be the percentage of patients experiencing rebound pain within 24 hours postoperatively. Secondary outcomes include the Numeric Rating Scale (NRS) score of rebound pain, the onset of rebound pain, (since performing SCB), the cumulative area under the curve of NRS pain severity scores through 48 hours postsurgery, postoperative opioid consumption at 48 hours postoperatively, onset and duration of the sensory blockade, onset and duration of the motor blockade and adverse reactions and adverse events. Patients will be followed-up to 48 hours postoperatively.

Discussions
This protocol describes the design of a randomised controlled trial to evaluate the effect of different modes of administration of esketamine combined with SCB on the incidence of rebound pain after upper limb fracture surgery. The results may help to identify the most effective methods for managing pain in patients undergoing upper limb fracture surgery.

Ethics and dissemination
This study has been approved by the Ethics Committee of the Deyang People’s Hospital (2023-03-010-K01). It was registered on the Chinese Clinical Trials Registry on 24 August 2023. We intend to publish the results in a peer-reviewed journal.

Trial registration number
ChiCTR2300075083.

Leggi
Dicembre 2024

Social Health Insurance for Universal Health Coverage in Low and Middle-Income Countries (LMICs): a retrospective policy analysis of attainments, setbacks and equity implications of Kenyas social health insurance model

Objectives
To analyse the potential of the Social Health Insurance (SHI) model to support the achievement of Universal Health Coverage (UHC) in Low and Middle-Income Countries (LMICs) through a policy analysis case study of Kenya’s National Health Insurance Fund (NHIF).

Design
We used an adaptation of the policy triangle framework to perform a retrospective policy analysis of Kenya’s NHIF, drawing from semistructured interviews and analysis of published documents and grey literature.

Setting
We focused on Kenya’s NHIF as a case study.

Participants
We conducted 21 interviews with key stakeholders including policy experts, healthcare providers and formal and informal sector workers. We then triangulated the interview findings with document analysis.

Results
Only 17% of Kenya’s population are currently covered by the SHI as of 2023. Only 27% of the informal economy is covered by the NHIF, implying very low uptake and/or retention rates. We found little stakeholder engagement in the policy implementation process and minimum adoption of expert advice. Our analysis suggest that political affiliations and positions of power heavily influence health financing policies in Kenya. Purchasing and payment of healthcare was found to be riddled with inefficiencies, including slow bureaucratic reimbursement procedures, little expertise by rural hospital clerks, misappropriations and favouritism of specific private healthcare providers. We also found that group-based parallel schemes and penalty payments for defaulted premiums widened the existing inequity gap in healthcare access.

Conclusion
Although the SHI system is perceived to increase coverage and the quality of health services in Kenya, substantial structural and contextual challenges appear to deter its suitability to finance the attainment of Universal Health Coverage. From Kenya’s experience, we identify little informal sector participation, inefficiencies in purchasing and payment of healthcare services, as well lack of political goodwill, as key bottlenecks for the implementation of SHI schemes in LMICs. LMICs adopting SHI need to also implement co-financing arrangements that do not impose on the population to co-finance, strategic purchasing systems, political goodwill and good governance for the SHI systems to be beneficial.

Leggi
Dicembre 2024

Gender differences in antibiotic use behaviour and access to antibiotics in low- and middle-income countries: a scoping review protocol

Introduction
In low- and middle-income countries (LMICs), the persistent lack of access and high inappropriate use of antibiotics, which are fuelled by gender-related factors, continue to facilitate antimicrobial resistance. This in turn reduces the capacity to treat infectious diseases. However, there is a lack of clarity on the nature and extent of the available evidence on gender influence on access to antibiotics and antibiotic use behaviour. This proposed study will systematically review the available literature to map out the scope of evidence on gender differences and, importantly, the related factors influencing antibiotic use and access to antibiotics in LMICs.

Methods and analysis
This scoping review will be conducted using the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines for scoping reviews. Major databases (MEDLINE, PsycINFO and CINAHL) will be searched via the EBCOhost and Web of Science platforms for peer-reviewed articles. Title and abstract screening, as well as full paper review, will be conducted by a single reviewer, with 20% of identified citations reviewed independently by two other reviewers. A predefined excel spreadsheet will be used for data extraction and analysis. Findings will be presented thematically in a narrative summary and tables.

Ethics and dissemination
Obtaining ethics approval is not required for this study. The findings will contribute to understanding gender health inequalities and areas for further research on strategies to incorporate gender considerations in antimicrobial stewardship efforts in LMICs. The study findings will be disseminated through presentations in seminars, scientific conferences and publications in peer-reviewed journals.

Leggi
Dicembre 2024

Different doses of epidural morphine combined with multimodal analgesia strategies for postpartum pain management: study protocol for a single-centre, double-blind randomised, pragmatic clinical trial

Introduction
The neuraxial morphine has been regarded as the gold standard for postpartum analgesia. However, the recent advancements in patient-controlled analgesia and various regional nerve blocks have led to the implementation of multimodal analgesia strategies, which aim to reduce opioid usage and associated complications while ensuring satisfactory pain relief. The objective of this research is to investigate the optimal dosage of epidural morphine for alleviating moderate and severe pain after caesarean sections in healthy parturients, as well as reducing unnecessary burden of respiratory monitoring resources.

Methods and analysis
The present single-centre randomised controlled pragmatic clinical trial aims to enrol a total of 310 healthy parturients with American Society of Anesthesiologists grade I/II, who are scheduled for caesarean section under combined spinal and epidural anaesthesia at West China Second University Hospital of Sichuan University. The recruitment process has not yet commenced and is anticipated to commence in March 2024, concluding in September 2024. Enrolled patients will be evenly distributed into five groups, namely morphine groups (M1–M4) and the control group (M0). The primary outcome measure is the incidence rate of postoperative use Numerical Rating Scale (NRS) pain score ≥4 points within 24 hours, which will be primarily assessed through bedside follow-up conducted by investigators and patient self-assessment at 2, 4, 6, 8, 12 and 24 hours postoperatively. The secondary outcomes encompass the following: incidence of postoperative NRS score ≥4 within 48 hours, occurrence of SpO2

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Dicembre 2024

Engaging stakeholders in Non-communicable diseases (NCDs) Implementation Research in low- and middle-income countries (LMICs): a scoping review protocol

Introduction
Non-communicable diseases (NCDs) present a significant health challenge globally, especially in low- and middle-income countries (LMICs). Effective Implementation Research (IR) is vital in addressing this challenge, with stakeholder engagement playing a crucial role. However, the landscape of stakeholder engagement in NCD IR within LMICs faces unique challenges, including resource constraints and power imbalances. Despite these challenges, stakeholder engagement offers substantial benefits, including improved research relevance and sustainability of interventions.

Methods and analysis
This scoping review aims to comprehensively describe the current practices of stakeholder engagement in NCD IR within LMICs. Employing a two-stage screening process and a thematic synthesis approach based on the International Association for Public Participation Spectrum of Public Participation, the review will analyse studies meeting predefined eligibility criteria. A rigorous search strategy will be implemented across identified electronic databases and grey literature sources, including published studies from 2011 to present. Data will be charted using a standardised form, and information regarding study characteristics, NCD focus, LMIC context, stakeholder engagement method and reported outcomes/findings will be collected. This scoping review will follow a standard protocol adhering to the methodological framework outlined by Arksey and O’Malley to comprehensively map existing evidence on stakeholder engagement in NCD IR within LMICs.

Ethics and dissemination
Ethical considerations involve respecting original authors, maintaining integrity and transparency, managing data ethically and disclosing conflicts of interest. Dissemination will occur through publication in peer-reviewed journals, conference presentations, open-access repositories, policy briefs, stakeholder engagement activities and social media platforms.

Registration
This scoping review protocol is registered on Open Science Framework, with the Digital Object Identifier 10.17605/OSF.IO/ACQ52, ensuring transparency and accountability in the research process.

Leggi
Dicembre 2024

Cost-effectiveness of long-acting progestogens versus the combined oral contraceptives pill for preventing recurrence of endometriosis-related pain following surgery: an economic evaluation alongside the PRE-EMPT trial

Objectives
To evaluate the cost-effectiveness of long-acting progestogens (LAP), including levonorgestrel-releasing intrauterine system (LNG-IUS) and depot-medroxyprogesterone acetate (DMPA), compared with the combined oral contraceptives pill (COCP) in preventing recurrence of endometriosis-related pain postsurgery.

Design
Within-trial economic evaluation alongside a multicentre, pragmatic, parallel-group, open-label, randomised controlled trial (Preventing Recurrence of Endometriosis by means of Long-Acting Progestogen Therapy trial).

Setting
Thirty-four UK hospitals recruiting participants from November 2015 to March 2019.

Patients
Four hundred and five women aged 16–45 years undergoing conservative endometriosis surgery.

Interventions
The ratio of 1:1 randomisation to receive LAPs (LNG-IUS or DMPA) or COCP.

Main outcome measures
The primary evaluation was a cost-utility analysis based on cost per quality-adjusted life-year (QALY) gained at 3 years. We adopted a UK National Health Service perspective. Secondary analyses in the form of cost-effectiveness analysis based on a range of outcomes were also undertaken.

Results
For the primary analysis, the COCP group incurred an additional cost of £533 (95% CI £52 to £983) per woman compared with LAPs. Treatment with COCP generated additional QALYs of 0.031 (95% CI –0.079 to 0.139) compared with the LAP group over 36-month follow-up. The incremental cost-effectiveness ratio for COCP compared with LAPs is therefore approximately £17 193 per QALY. The probabilistic sensitivity analysis suggested that there was a 54.7% probability that COCP would be cost-effective at the £20 000/QALY threshold. The secondary analyses revealed results more in favour of LAPs.

Conclusion
Although the COCP has a slightly higher probability of being cost-effective at £20 000/QALY threshold, there remains considerable uncertainty, with only marginal differences in outcomes between the two treatments. The lower rates of further surgery and second-line medical treatment for women allocated to LAPs may make this option preferable for some women.

Trial registration number
ISRCTN 97865475.

Leggi
Dicembre 2024

Low Penetrance Sarcomere Variants Contribute to Additive Risk in Hypertrophic Cardiomyopathy

Circulation, Ahead of Print. BACKGROUND:Classically, hypertrophic cardiomyopathy (HCM) has been viewed as a single-gene (monogenic) disease caused by pathogenic variants in sarcomere genes. Pathogenic sarcomere variants are individually rare and convey high risk for developing HCM (highly penetrant). Recently, important polygenic contributions have also been characterized. Low penetrance sarcomere variants (LowSVs) at intermediate frequencies and effect sizes have not been systematically investigated. We hypothesize that LowSVs may be common in HCM with substantial influence on disease risk and severity.METHODS:Among all sarcomere variants observed in the Sarcomeric Human Cardiomyopathy Registry (SHaRe), we identified putative LowSVs defined by (1) population frequency greater than expected for highly penetrant (monogenic) HCM (allele frequency >5×10-5in the Genome Aggregation Database, gnomAD) and (2) moderate enrichment ( >2×) in patients with HCM compared with gnomAD. LowSVs were examined for their association with disease severity and clinical outcomes. Functional effects of selected LowSVs were assessed using induced pluripotent stem cell–derived cardiomyocytes. Association of LowSVs with HCM-adjacent traits in the general population was tested using UK Biobank cardiac magnetic resonance imaging data.RESULTS:Among 6045 patients and 1159 unique variants in sarcomere genes, 12 LowSVs were identified. LowSVs were collectively common in the general population (1:350) and moderately enriched in HCM (aggregate odds ratio, 14.9 [95% CI, 12.5–17.9]). Isolated LowSVs were associated with an older age of HCM diagnosis and fewer adverse events. However, LowSVs in combination with a pathogenic sarcomere variant conferred higher morbidity (eg, composite adverse event hazard ratio, 5.4 [95% CI, 3.0–9.8] versus single pathogenic sarcomere variant, 2.0 [95% CI, 1.8–2.2];PA (partial splice gain) andTNNT2c.832C >T (intermediate effect on contractile mechanics). Cardiac magnetic resonance imaging analysis of the general population revealed 5 of 12 LowSVs were significantly associated with HCM-adjacent traits without overt HCM.CONCLUSIONS:This study establishes a new class of low penetrance sarcomere variants that are relatively common in the population. When penetrant, isolated LowSVs cause mild HCM. In combination with pathogenic sarcomere variants, LowSVs markedly increase disease severity, supporting a clinically significant additive effect. Last, LowSVs also contribute to age-related remodeling even in the absence of overt HCM.

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Dicembre 2024

Evaluating low back pain through electrodermal activity: a systematic review protocol

Introduction
Low back pain (LBP) is a prevalent and multifaceted health condition affecting over 619 million people globally. Today, pain evaluation heavily relies on subjective measures, so more advanced diagnosis and treatment methods are required. Electrodermal activity (EDA) could represent a potential objective tool to assess LBP. Despite its promise, EDA has been less studied in this context, and the methodologies vary across studies. The systematic review described thus aims to determine the relationship between EDA and LBP as well as the potential utility of EDA as a tool for evaluating LBP. The various EDA measurement methodologies employed to detect LBP will also be analysed to ultimately identify the most reliable and effective approaches.

Methods and analysis
The primary databases include PubMed, Web of Science (all databases) and Scopus. The search strategy will be tailored to identify articles written in English or Spanish without imposing any time restrictions. The snowballing technique will also be used to identify additional studies by reviewing the reference lists of relevant articles or citing articles.
Eligible studies will encompass adults with both acute and chronic LBP. A diverse range of research designs will be considered, focusing on the relationship between EDA and LBP. PEDro scale and Cochrane Risk of Bias tool 2.0 (RoB2) will be used to assess the methodological quality and risk of bias in the studies, respectively. Data synthesis will be based on a structured presentation of participant characteristics, methodological details and EDA-related variables.

Ethics and dissemination
This protocol of systematic review, registered in the International Prospective Register of Systematic Reviews, adheres to the PRISMA checklist. The study findings will be disseminated through publication in peer-reviewed journals. The search process is forecast to end on 30 November 2024. Adhering to Spanish guidelines, ethical approval is deemed unnecessary for our secondary analyses, given the de-identification and anonymous analysis of all data.

PROSPERO registration number
CRD42023464812.

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Dicembre 2024

Enhancing provider-patient connection through low-effort interventions: a scoping review protocol

Introduction
Nudges, or low-effort interventions aimed at influencing behaviour, can improve provider medical decision-making through promoting adherence to practice guidelines. Strengthening provider–patient humanistic connection through nudges may increase provider satisfaction, mitigate burnout and improve patient satisfaction and outcomes. This scoping review aims to map the literature investigating provider-directed, low-effort interventions aimed at enhancing the provider–patient connection.

Methods and analysis
The authors conducted a preliminary search to identify terms that will be used in the final search strategy. The search follows Joanna Briggs Institute guidelines and will be used to query Ovid MEDLINE, Embase, PsycINFO and Cochrane databases. Two authors will work independently to screen abstracts and full text. We will summarise the findings using descriptive statistics and narrative synthesis and will use SEIPS 2.0 as the anchoring framework.

Ethics and dissemination
As a secondary analysis of published data, this study does not require ethics approval. The results will be submitted to relevant academic peer-reviewed journals and conferences. We anticipate that the interventions surveyed in this scoping review will have the potential to be incorporated into clinical practice at an individual and systemic level with the goal of enhancing providers’ sense of meaning connected to their work, mitigating burnout and improving the patient experience.

Leggi
Dicembre 2024

Impact of edentulism on community-dwelling adults in low-income, middle-income and high-income countries: a systematic review

Objectives
This study aims to comprehensively explore the consequences of edentulism on community-dwelling adults in low-income, middle-income and high-income countries.

Design
Systematic review and Synthesis Without Meta-Analysis (SWiM).

Data sources
MEDLINE, Embase, Scopus, Web of Science and the Cochrane Central Register of Controlled Trials (CENTRAL) were searched from inception to 21 March 2023, in addition to grey literature searches, reference cross-checking and study recommendations.

Eligibility criteria
Interventional and observational epidemiological studies of community-dwelling completely edentulous adults aged 18 years and above, residing in low-income, middle-income and high-income countries were included. Animal studies, studies of children and adolescents, studies of exclusively non-community-dwelling individuals and studies exclusive to partially dentate, dentate and treated edentulous individuals were excluded. There were no language restrictions. Search terms were designed to identify relevant articles, which examined the impact of edentulism on oral health-related quality of life, frailty, general health, physical health, mental health, nutritional status, employability, education, socioeconomic status and mortality.

Data extraction and synthesis
Data were extracted manually by two authors. Risk of bias was assessed using the QualSyst Tool. Articles were synthesised and reported using SWiM guidelines.

Results
The seven broad outcome areas included mortality, frailty, mental health, general health, quality of life, health behaviour and nutrition. We identified no studies assessing the impact of edentulism on productivity or other economic outcomes, and no randomised trials of treatment for edentulism with any of these outcomes. Among 364 articles identified from database searches and 38 additional articles from reference cross-checks and professional recommendations, title and abstract screening resulted in a full text review of 58. Among these, 32 were subsequently included for narrative synthesis, with sample sizes ranging from 539 to 237 023 participants. All studies (n=32) contributing to the synthesis reported negative impact of edentulism on outcomes including mortality, frailty, mental health, general health, cognition and nutrition.

Conclusions
Edentulism has a consistently negative impact on the health outcomes examined in this review. Randomised trials are needed to evaluate interventions reducing the burden of edentulism, specifically with regard to economic and productivity outcomes.

PROSPERO registration number
CRD42022320049.

Leggi
Dicembre 2024