Risultati per: Low Back Pain: raccomandazioni

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

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.

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.

Acupuncture might be an effective treatment for patients with chronic sciatica from a herniated disk, according to the results of a clinical trial recently published in JAMA Internal Medicine.

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.

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.

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.

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.

Background
Chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS) has posed a significant burden on affected individuals and healthcare systems. While pharmacological treatments are commonly used, non-pharmacological management strategies have gained attention for their potential benefits in improving CP/CPPS symptoms. However, the comparative efficacy of these non-pharmacological interventions remains unclear. The aim of this study is to assess the comparative effectiveness of non-pharmacological interventions for CP/CPPS regarding prostatic symptoms.

Method
This systematic review and network meta-analysis will follow the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. A comprehensive search will be conducted in electronic databases, including PubMed, Embase, Cochrane Library and Web of Science, to identify relevant studies. Eligible studies will include randomised controlled trials investigating non-pharmacological management strategies for CP/CPPS. Two independent reviewers will screen the retrieved citations, extract data and assess the risk of bias. Data synthesis will involve performing a network meta-analysis to compare the efficacy of different non-pharmacological interventions while considering both direct and indirect evidence.

Ethics and dissemination
The review does not require ethical approval. The findings of the review will be disseminated through publication in an academic journal, presentations at conferences and various media outlets.

PROSPERO registration number
CRD42024506143.

Introduction
Pain surrounding major lower extremity amputations (MLEAs) in the vascular surgical patient can be severe, conferring significant debilitation from the preoperative stage through to the chronic rehabilitation phase. Although there is an evolving understanding of the array of existing analgesic medications and modalities, pain management in this context continues to be challenging. A previous report in the UK revealed that MLEA pain management practices may not be optimal from the perspective of patients. There are also limitations in the comprehensiveness and quality of existing evidence, and existing practices can be heterogeneous. Identifying effective pain management approaches in MLEA has thus been recognised as a key practice and research priority. Therefore, the aim of this study protocol will be to elucidate a multi-specialty view on the perceptions, processes and approaches to perioperative pain management in patients undergoing MLEAs secondary to vascular disease in the UK.

Methods and analysis
A modified Delphi methodology will be used to gain consensus among a UK-wide multi-specialty panel of clinical experts. At least three iterative rounds of structured anonymous electronic surveys will be circulated to a minimum cohort of 40 participants across relevant specialties. Expert agreement on pre-developed consensus statements pertaining to the approaches and techniques in MLEA pain management will be sought from the first round and quantified by a 5-point Likert scale. Quantitative and qualitative analyses will be performed to evaluate the level of agreement and participant feedback, respectively. A consensus criterion of ≥75% panellist agreement with a ≤10% between-round stability will be used for each statement. The process will be repeated with the results and implementation of feedback highlighted to panellists in each subsequent round.

Ethics and dissemination
Ethical approval was not required for this study as the participants and methodology fall outwith the requirements for a National Health Service Research Ethics Committee review. The results will be disseminated in a peer-reviewed publication and presented at relevant conferences.

Introduction
Cognitive–behavioural therapy (CBT) is an effective treatment for chronic primary pain (CPP), but effect sizes are small to moderate. Process orientation, personalisation, and data-driven clinical decision-making might address the heterogeneity among persons with CPP and are thus promising pathways to enhance the effectiveness of CBT for CPP. This study protocol describes one approach to personalise CBT for CPP using network analysis.

Methods and analysis
A single-case experimental design with multiple baselines will be combined with ecological momentary assessment (EMA). Feasibility and acceptance of the study procedure will be demonstrated on a sample of n=12 adults with CPP in an outpatient clinic. In phase A, participants complete 21 days of EMA, followed by the standard diagnostic phase of routine clinical care (phase B). Person-specific, process-based networks are estimated based on EMA data. Treatment targets are selected using mean ratings, strength and out-strength centrality. After a second, randomised baseline (phase A’), participants will receive 1 out of 10 CBT interventions, selected by an algorithm matching targets to interventions, in up to 10 sessions (phase C). Finally, another EMA phase of 21 days will be completed to estimate a post-therapy network. Tau-U and Hedges’ g are used to indicate individual treatment effects. Additionally, conventional pain disability measures (Pain Disability Index and the adapted Quebec Back Pain Disability Scale) are assessed prior, post, and 3 months after phase C.

Ethics and dissemination
Ethical considerations were made with regard to the assessment-induced burden on the participants. This proof-of-concept study may guide future studies aiming at personalisation of CBT for CPP as it outlines methodological decisions that need to be considered step by step. The project was approved by the local ethics committee of the psychology department of University Kaiserslautern-Landau (#LEK-457). Participants gave their written informed consent prior to any data assessment and app installation. The results of the project will be published, presented at congresses, and relevant data will be made openly accessible via the Open Science Framework (OSF).

Trial registration number
NCT06179784.

Presidenza Ue: ‘Nessun divieto obbligatorio, scelta agli Stati’

Annals of Internal Medicine, Ahead of Print.

Annals of Internal Medicine, Ahead of Print.

This case series examines the effectiveness of low-dose naltrexone in treating nail lichen planus.