Search Results for: Low Back Pain: raccomandazioni

Introduction
Pre-eclampsia (PEC) is a morbid and potentially lethal complication of pregnancy and is more common in women with risk factors such as hypertension, diabetes, autoimmune disease, kidney disease or multifetal pregnancies. Low dose aspirin (ASA) is currently the only prophylactic therapy known to decrease PEC in this patient population. However, currently, there is no prospective literature comparing various low-dose ASA formulations in the risk reduction of PEC. In the USA, the currently available low-dose ASA is over-the-counter and found in 81 mg tablets. Therefore, when clinicians initiate low-dose ASA therapy, they may prescribe one or two tablets of 81 mg per day without comparative evidence to guide their decision. Our objective is to prospectively compare pregnant patients on 81 mg vs 162 mg of ASA and determine a possible dose response in the prevention of PEC.

Methods and analysis
We designed a pragmatic phase 3 prospective randomised open label blinded-end point clinical trial with parallel assignment between two groups of pregnant people at high risk for PEC, as defined by the US Preventive Services Task Force and American College of Obstetricians and Gynecologists (ACOG). The primary outcome is the incidence of preterm (

Introduction
Differences in the profile of the vaginal microbiota (VMB) have been associated with pregnancy rates after medical assisted reproduction (MAR) such as in vitro fertilisation (IVF) or intracytoplasmic sperm injection (ICSI). Monitoring the VMB profile of IVF patients creates an opportunity to identify the best window for IVF treatment and embryo transfer. The ReceptIVFity test is a predictive test that assesses the chances of becoming pregnant in women undergoing IVF treatment based on the VMB composition. A VMB profile dominated by beneficial strains, most notably Lactobacillus species, is associated with increased pregnancy chances. However, to date, limited evidence is available on the effect of active modification strategies to facilitate the modulation of the VMB profile to help restore a VMB dominated by Lactobacillus species.

Methods and analysis
This is a randomised, placebo-controlled, double-blind intervention study. The study will involve 1:1 randomisation to one of the two arms: oral probiotic or placebo. Vaginal and rectal swabs will be collected at intake and 4, 6 and 8 weeks after the start of the treatment. Our objective is to determine if oral probiotic treatment improves the VMB profile of IVF patients from a low to a medium/high ReceptIVFity score, compared with placebo treatment. Secondary outcomes are: the potential of the bacterial strains in the oral probiotic to be detected in the vaginal tract and/or in the gut, and if the treatment leads to an increased ongoing pregnancy rate after IVF.

Ethics and dissemination
Ethical approval was obtained by the local medical ethical review committee at the Maastricht University Medical Centre. Findings from this study will be published in a peer-reviewed scientific journal and presented at one or more scientific conferences.

Trial registration number
CCMO NL81210.068.22, registered 25 September 2023.

In a retrospective study, patients receiving direct oral anticoagulants had similar rates of intracranial hemorrhage compared with recipients of low-molecular-weight heparin.

Purpose
The SEV-IDF programme aims to track infants born before 33 weeks of gestation, with very low birth weight (VLBW), neonatal encephalopathy or severe birth anomalies and perinatal disease. It employs an open, prospective, multicentric, population-based cohort approach. This report aims to describe the methodology employed to establish and manage the programme, details regarding follow-up procedures, baseline characteristics of the included infants, and highlights new research opportunities emerging from the “Suivi des Enfants Vulnérables d’Ile-de-France” (SEV-IDF) programme.

Participants
The programme aims to (1) detect developmental anomalies early, (2) improve prevention using standardised data, (3) optimise follow-up care and (4) support multidisciplinary research.
Eligible participants are infants alive at discharge from the 59 maternities with a neonatal unit of the Île-de-France (IDF) region (France). A network of 567 trained physicians monitors the children’s development at 4 months, 1 and 2 years of corrected age, and 3, 4, 5, 6 and 7 years of age. Collected data include sociodemographic, pregnancy and neonatal characteristics, and standardised child development scores.

Findings to date
The programme enrolled 21 175 participants between 2016 and 2023, with 16 461 (77.7%) having a gestational age less than 33 weeks, 1916 (9.0%) others having VLBW, 1525 (7.2%) having encephalopathy and 1273 (6.0%) having another severe birth anomaly.

Future plans
The collected data will enable the SEV-IDF scientific committee to describe high-risk infants in the IDF region, design evidence-based campaigns to improve the quality and effectiveness of the follow-up as well as conduct research on developmental anomalies in these high-risk infants. Ongoing research currently focuses on anticipating loss to follow-up and early detection of developmental anomalies.

Introduction
Patients with total hip arthroplasties and hemiarthroplasties are both subject to hip dislocations. Although the incidence of complications differs, both patient groups suffer immediate high pain and need acute treatment. The purpose of this study is to design a fast-track pathway for patients with a dislocated hip prosthesis primarily to reduce the time from arrival to reduction and the total hospitalisation time. The secondary aim is to investigate whether quicker prosthesis reduction influences subsequent hip function and quality of life, reduces pain experience immediately and in the long term, and increases patient satisfaction.

Methods and analysis
This is a prospective observational cohort study, initiated on 1 December 2024 and continuing for 2 years. During the first year, patients admitted to the University Hospital of Southern Denmark, Esbjerg, will follow the current standard treatment pathway. After 1 December 2025, a newly developed treatment pathway (fast-track) will be adhered to. Based on a sample size calculation, 120 patients will be included. The main clinical outcomes (time to reduction (primary outcome), total hospitalisation) are registered from patient files. The patients are followed up for 1 year to measure patient-reported outcomes.

Ethics and dissemination
The study is conducted as a treatment quality study and is locally approved by the Executive Board at the University Hospital of Southern Denmark. The results will be published in relevant national and/or international journals and presented at relevant congresses.

Trial registration number
NCT06639334.

Background
Migrants and refugees with low language proficiency (LLP) in the dominant language of their host country have a higher risk of suffering from certain mental health disorders compared with non-migrant populations. They are also more likely to experience a lack of access to mental healthcare due to language-related and culture-related barriers. As part of the MentalHealth4All project, a digital multilingual communication and information platform was developed to promote access to mental healthcare for LLP migrants and refugees across Europe. This paper describes the study protocol for evaluating the platform in practice, among both health and/or social care providers (HSCPs) and LLP migrants and refugees.

Methods and analysis
We will conduct a pretest–post-test cross-national survey study to evaluate the platform’s effect evaluation (primary objective) and process evaluation (secondary objective). The primary outcomes (measured at T0, T2 and T3) are four dimensions of access to mental healthcare services: availability, approachability, acceptability and appropriateness of mental healthcare. Secondary outcomes (measured at T2) are: actual usage of the platform (ie, tracking data), perceived ease of use, usefulness of content, comprehensibility of information, attractiveness of content and emotional support. Participants will be recruited from nine European countries: Belgium, Germany, Italy, Lithuania, the Netherlands, Poland, Slovakia, Spain and the UK. Using convenience sampling through professional networks/organisations and key figures, we aim to include at least 52 HSCPs (ie, 6–10 per country) and 260 LLP migrants (ie, 30–35 per country). After completing a pretest questionnaire (T0), participants will be requested to use the platform, and HSCPs will participate in an additional personalised training (T1). Next, participants will fill out a post-test questionnaire (T2) and will be requested to participate in a second post-test questionnaire (T3, about 6–8 weeks after T2) to answer additional questions on their experiences through a brief phone interview (T3 is optional for migrants/refugees).

Ethics and dissemination
For all nine countries, the ethical review board of the participating university (hospital) has assessed and approved the protocol. If successful, the MentalHealth4All platform will be made publicly available to help improve access to mental healthcare services, as well as HSCPs’ cultural competencies in delivering such services, for any LLP migrants and refugees across Europe (and beyond). Findings will also be disseminated through peer-reviewed journals and conferences.

Registration details
The ‘MHealth4All project’ was prospectively registered on Open Science Framework, DOI: 10.17605/OSF.IO/U4XSM.

Introduction
Globally, drug shortages affect low-, middle- and high-income countries to different degrees. The challenges associated with drug shortages in health systems, particularly in public health facilities, and the consequent multiple adverse effects on patients and the health systems have led countries to continue to explore and implement different strategies to combat this challenge. Various factors implicated in drug shortages range from manufacturing concerns, demand issues, supply chain disruptions and regulatory issues. The effects of drug shortages in health systems range from poor patient compliance and therapeutic failure to antimicrobial resistance, low morale among healthcare workers and public distrust in government services. Furthermore, the effects of drug shortages in public health facilities include unavailability of drugs to patients, hospitalisation and readmissions, and associated costs that could be avoided, high out-of-pocket expenditures suffered by patients as patients resort to buying drugs from private pharmacies where the prices are usually exorbitant and prohibitive, putting patients at risk of treatment default due to lack of affordability. Successful mitigation strategies deployed to prevent and manage drug shortages in sub-Saharan Africa (SSA) remain unshared despite the potential of these strategies to serve as valuable lessons if the evidence is scientifically synthesised and reported. The scoping review will synthesise evidence to provide policy guidance for better planning of health services and resources, resulting in improved quality of life for citizens, underscoring the importance of functional and responsive health systems.

Methods and analysis
Using the Joanna Briggs Institute (JBI) scoping review methodology, a five-stage review is outlined: (1) determining the research question, (2) search strategy, (3) inclusion criteria, (4) data extraction and (5) analysis and presentation of the results. The literature search will use PubMed, SCOPUS and the Elsevier Science Direct search interfaces, reflecting empirical and grey literature. We will focus on literature published between 2000 and 2025. The study start and end dates are 1 September–30 November 2025. A two-stage screening process will be used to determine the eligibility of articles. All articles will be individually assessed for eligibility by two reviewers, while a third reviewer will resolve any disagreements. The data from eligible articles will be extracted and charted using a standardised form. Extracted data will be analysed using narrative and descriptive analyses.

Ethics and dissemination
Ethical approval is not required for this scoping review as it will use only previously published data. It does not require human participation. The results of this search will be disseminated through academic presentations at conferences and peer-reviewed publications.

Introduction
The COVID-19 pandemic amplified the need for robust multisectoral coordination; yet the specific mechanisms, benefits and challenges of such collaboration particularly in low- and middle-income countries (LMICs) remain poorly synthesised. This review aims to delineate the key elements, benefits, challenges and improvement strategies of multisectoral coordination during COVID-19 and to compare patterns between LMICs and high-income countries (HICs).

Methods and analysis
Eligible studies will include empirical qualitative, quantitative or mixed-methods research published in English between 1 January 2020 and 15 August 2024 that examines formal coordination mechanisms (eg, task forces, public-private partnerships, inter-agency committees) within the context of COVID-19. Searches will be conducted across PubMed, EBSCOhost, Emerald Insight, Google Scholar and selected grey-literature repositories. Citation chaining will be employed to identify additional sources.
Two reviewers will independently screen all records using Covidence, applying pre-piloted eligibility criteria to 5% of citations and proceeding only if inter-rater reliability achieves ≥0.70. Data will be extracted into a Consolidated Framework for Implementation Research (CFIR)-informed template. Qualitative data will be analysed through framework synthesis, structured by the five CFIR domains. Quantitative data will be narratively summarised and, where outcomes are sufficiently similar across at least two studies, synthesised using a fixed-effect model.
Risk of bias will be assessed using Critical Appraisal Skills Programme for qualitative and Risk Of Bias In Non-randomised Studies of Interventions for non-randomised studies. Studies with serious or critical risk will be excluded from pooling. Subgroup analyses (LMIC vs HIC), sensitivity analyses (model and risk) and confidence grading using Confidence in the Evidence from Reviews of Qualitative Research and Grading of Recommendations, Assessment, Development and Evaluations will be conducted.

Ethics and dissemination
No primary data will be collected; thus additional Research Ethics Committee approval is unnecessary. The results will be disseminated via open-access publication, conference presentations and policy briefs for Nairobi County health stakeholders.

PROSPERO registration number
CRD42023466849.

This randomized clinical trial compares the effects of robotic surgery vs conventional laparoscopic surgery on 3-year locoregional recurrence rates in patients with middle or low rectal cancer.

Poetry catalyzes memory, as other poems featured in JAMA have variously demonstrated. It is used directly among patients with dementia in programs such as the Alzheimer’s Poetry Project to reproducibly beneficial effect. “Missing Father” offers another example of the connections between poetry and memory. The poem both describes actual memories while at the same time seeming to spark more of them. The paradoxical double meaning of the title both reports on and grieves for the lost voice of the storyteller father—he is both absent and an actively yearned-for presence—while the first line’s immediacy of “this morning being” ironically unleashes vivid memories, from the sound of his voice “rising/from the worn pages” of a picture book to the uncanny word-picture of the speaker and her twin sister eagerly awaiting his return from work, “pajamas hanging on us/like wilted petunias.” The poem reanimates them all together as they chant the names of the book’s characters, simultaneously recalling both the tenderness of a distant childhood and enacting poetry’s mooted origins in the passing down of community wisdom through incantatory language. Yet even as poetry facilitates such recollection, and helps sustain the more practical, trying search for “nursing homes close and affordable,” ultimately it cannot bring back the long-gone, stricken father; instead, it becomes an act of healing, remembering that brighter time of more bearable loss, “a day when the only problem/was a carrot missing from/Mister McGregor’s garden.”

This Viewpoint explores the widespread effects cuts to Medicaid funding could have on the US medical system, including limitations on states, hospitals, and physicians, as well as low-income beneficiaries.

Background and aims
Quantifying systemic inflammation (SI) in acutely decompensated cirrhosis (ADC) is of major importance because SI is a driver of the most severe forms of ADC, including acute-on-chronic liver failure (ACLF). Blood biomarkers of SI already evaluated in ADC failed to appropriately assess SI in ADC. We aimed to investigate whether gene expression related to circulating immune cells could quantify SI in ADC.

Methods
Standard biomarkers (white cell count, C reactive protein, cytokines) and genome-wide RNA expression (RNA-sequencing) were obtained in blood from 700 patients with ADC at the time of their hospital admission. A composite score based on standard biomarkers of SI (Chronic Liver Failure-Standard Biomarkers Composite (CLIF-SBC) score) and a gene score (CLIF-Systemic Inflammation Gene (SIG) score) composed of the 28 top differentially expressed immune cell-related genes in the comparison between high-severity and low-severity clinical phenotypes were computed. Among the 700 patients, the CLIF-SIG score was repeated once during follow-up in 375 patients, and 3 times or more in 46 patients.

Results
The CLIF-SIG score was more accurate in reflecting clinical severity induced by SI than the CLIF-SBC score (area under the curve 0.803 vs 0.658). A CLIF-SIG score of 0.386 (Youden Index) was the best cut-off level discriminating patients with poor outcomes from the others, in all clinical scenarios. Sequential measurement of the CLIF-SIG score showed that 78% of patients were admitted at the peak or descending part of the SI-wave. ACLF developed during hospitalisation in 80% of patients with a CLIF-SIG score >0.386 on admission.

Conclusions
In patients with ADC, the CLIF-SIG score is an accurate estimator of SI, clinical course severity and prognosis.

Message Subepithelial lesions (SLEs) are often detected incidentally during endoscopic examination. They represent a heterogeneous group of lesions including non-neoplastic and neoplastic lesion, the most relevant of which may be gastrointestinal stromal tumour (GIST) and neuroendocrine tumours (NET). We report the biggest SELs database (4901 cases) on histology characteristics of different SELs resected endoscopically (mean size 1.45 cm, range 0.80–1.90 cm). In the oesophagus, leiomyomas comprised 95.7% of all lesions, while, in the stomach, GIST tumours were the predominant lesions (40.3%), but mostly in body (39.8%) and fundus (46.2%), much less so in the antrum (13.6%). Most of the gastric GISTs were of very low or low risk (93.1%). In the antrum, non-neoplastic lesions were most prominent (48.5%), and 20.1% lipomas were lipomas. Only a few lesions were resected in the duodenum (n=208), mostly non-neoplastic (35.6%), as were in the colorectum (n=592), with the vast majority being rectal NETs (55.9%)….

Clinical presentation A 26-year-old man was diagnosed with a 4-month history of ulcerative colitis. At the time of diagnosis, an abdominal CT showed a thickened colorectum (figure 1A) and a normal liver (figure 1B). He was started on mesalazine 4 g/day and received this for approximately 2 months without therapeutic benefit. He clinically deteriorated and was admitted to the hospital with a fever of up to 38.5°C daily, abdominal pain and diarrhoea. Laboratory findings revealed significantly elevated white blood cells (13.86×109/L), C reactive protein (69.5 mg/L) and elevated liver enzymes: aspartate aminotransferase 245 U/L, alanine aminotransferase 368 U/L (normal

Background
Early-onset gastric cancer (EOGC) is a lethal malignancy. It differs from late-onset gastric cancer (LOGC) in clinical and molecular characteristics. The current strategies for EOGC detection have certain limitations in diagnostic performance due to the rising trend in EOGC.

Objective
We developed a liquid biopsy signature for EOGC detection.

Design
We use a systematic discovery approach by analysing genome-wide transcriptomic profiling data from EOGC (n=43), LOGC (n=31) and age-matched non-disease controls (n=37) tissue samples. An extracellular vesicle-derived long non-coding RNA (EV-lncRNA) signature was identified in blood samples from a training cohort (n=299), and subsequently confirmed by qPCR in two external validation cohorts (n=462 and n=438), a preoperative/postoperative cohort (n=66) and a gastrointestinal tumour cohort (n=225).

Results
A three EV-lncRNA (NALT1, PTENP1 and HOTTIP) liquid biopsy signature was developed for EOGC detection with an area under the receiver operating characteristic curve (AUROC) of 0.924 (95% CI 0.889 to 0.953). This EV-lncRNA signature provided robust diagnostic performance in two external validation cohorts (Xi’an cohort: AUROC, 0.911; Beijing cohort: AUROC, 0.9323). Furthermore, the EV-lncRNA signature reliably identified resectable stage EOGC patients (stage I/II) and demonstrated better diagnostic performance than traditional GC-related biomarkers in distinguishing early-stage EOGC (stage I) from precancerous lesions. The low levels of this biomarker in postsurgery and other gastrointestinal tumour plasma samples indicated its GC specificity.

Conclusions
The newly developed EV-lncRNA signature effectively identified EOGC patients at a resectable stage with enhanced precision, thereby improving the prognosis of patients who would have otherwise missed the curative treatment window.

Introduction
Guidelines for symptomatic knee osteoarthritis (OA) dictate the initiation of conservative treatment (physical therapy, analgesics and intra-articular injections with corticosteroids) as a first line defence. When conservative treatment fails, the golden standard is invasive joint replacement surgery, but for a substantial group of patients who do not respond to the current conservative treatment, this is not (yet) indicated. The RADIOPHENOL study investigates if denervation of knee sensory (genicular) nerves can serve the gap between conservative and invasive treatment for younger patients and for patients who cannot undergo joint replacement surgery due to comorbid health conditions.

Methods and analysis
The RADIOPHENOL study is a multicentre unblinded randomised controlled trial with three parallel arms (1:1:1). In total, 192 patients with knee OA Kellgren-Lawrence grades 2–4 but not eligible for joint replacement according to the orthopaedic surgeon due to young age, old age and/or comorbidity or technical reasons are eligible and will be randomised to three groups of 64 patients. Group A: traditional radiofrequency ablation, group B: chemical neurolysis with phenol, group C: conservative medical management. Primary outcome is the Oxford Knee Score at 6 months. Secondary outcomes include Western Ontario and McMaster Universities Osteoarthritis Index, knee pain by numeric rating scale, physical functionality, health-related quality of life, mental health, change in medication use, predictive value of a diagnostic block, procedure time, patient discomfort score during the intervention and adverse events.

Ethics and dissemination
The protocol (V.2.0, 15 May 2023), was approved by the Ethics Committee of Amsterdam UMC (NL83410.018.22 – METC2022.0890) on 31 July 2023. We aim to publish our results in international peer-reviewed journals.

Trial registration details
ClinicalTrials.gov NCT06094660, including the WHO Trial Registration data set items. Registered on 20 October 2023, first patient enrolled on 27 November 2023.