Risultati per: Low Back Pain: raccomandazioni

Introduction
In primary care, the prevalence of neck pain has increased substantially. Evidence regarding treatment of chronic neck pain (CNP) is scarce, and its effectiveness is not entirely proven in different stages of chronicity, nor for different types of cervical disorders. The goal of this study is to evaluate the effectiveness of a complex intervention (COGMO intervention) compared with usual practice in primary care physiotherapy to improve neck pain intensity, severity and disability in patients with CNP.

Methods and analysis
Design: a pragmatic cluster-randomised clinical trial design with a 12-month follow-up. Setting: primary care. Participants: physiotherapists as randomisation unit, and patients as analysis unit. Inclusion criteria: individuals aged 18 to 65 years suffering from moderate to severe CNP. Sample size expected: 142 patients. Recruitment: patients referred from primary care physicians to physiotherapy. Intervention: pain neuroscience education (PNE), motivational interviewing (MI) and cognition targeted exercise therapy (CTE) compared with the standard treatment in primary care. Outcomes: the main variable is reduction in pain intensity; secondary variables include pain severity, conditioned pain modulation, temporal summation, neck disability, fear/avoidance behaviour, kinesiophobia, catastrophising, therapeutic alliance and quality of life. Sociodemographic information and adherence to the intervention will be recorded. Data collection: baseline, and follow-up at 3, 6 and 12 months. Analysis: it will follow intention-to-treat principles, and difference in percentage of subjects achieving success on the primary endpoint at 12 months. A model with multilevel analysis will be adjusted through logistic regression (being the dependent variable pain intensity, and the independent, the intervention).

Ethics and dissemination
Ethical approval has been awarded by the Regional Ethics Committee of Madrid (code: COGMO-AP) and the primary health care central commission of research (code: 20210011). The results of the study will be disseminated through international peer-reviewed journals, international conferences, press and social media.

Trial registration number
NCT05785455.

New England Journal of Medicine, Volume 392, Issue 8, Page 807-816, February 20, 2025.

New England Journal of Medicine, Volume 392, Issue 8, Page 788-797, February 20, 2025.

New England Journal of Medicine, Volume 392, Issue 8, Page 829-831, February 20, 2025.

Annals of Internal Medicine, Volume 178, Issue 2, February 2025.

Annals of Internal Medicine, Volume 178, Issue 2, February 2025.

We recently showed that a bacterial infection can break oral tolerance to food and lead to IgE-dependent mast cell activation and food-induced abdominal pain, which could constitute an important pathogenic mechanism in post-infectious irritable bowel syndrome (IBS). Here, we investigated whether similar immune mechanisms in response to psychological stress lead to food-evoked pain signaling, and thus potentially explain the pathophysiology in a larger group of patients with IBS.

Background
Hospital readmissions are an important quality of care indicator and are tied to hospitals’ financial reimbursements. Safety-net hospitals, which serve a high proportion of patients of low socioeconomic status (SES), face unique challenges to reduce or maintain low readmission rates.

Objective
We sought to understand strategies high-performing safety-net hospitals used to achieve low 30-day risk-standardised readmission rates (RSRRs) using qualitative methodology.

Methods
Safety-net hospital status was defined by public ownership or a Medicaid population that is greater than 1 SD higher than the state proportion of Medicaid patients and the hospital payer source is composed of at least 15% Medicaid patients. Safety-net hospitals were selected based on their ranking among the lowest 20% of heart failure RSRRs, the best-performing quintile. We purposefully sampled hospitals to ensure variation in characteristics and conducted on-site interviews with key hospital staff. A multidisciplinary team analysed the data using thematic analysis.

Results
We performed site visits at 9 safety-net hospitals (RSRR range: 18.1%–21.6%) in 9 states and conducted in-depth interviews with 108 hospital staff. Several thematic attributes and organisational strategies were evident in high-performing safety-net hospitals: (1) strong hospital support for quality improvement at all levels; (2) tailoring resources to meet patient needs; (3) facilitating collaboration and communication among and between providers and patients; (4) creating strong relationships with postacute care facilities and communities and (5) proactive approach to healthcare policy changes and other external factors.

Conclusions
The provision of high-quality and equitable care in hospitals serving a high proportion of low-SES populations is influenced by several modifiable factors. These findings may serve to inform lower-performing safety-net hospitals on how to optimise patient care and improve readmission outcomes.

Objectives
To evaluate the effectiveness of 18 different host biomarkers in differentiating bacterial from non-bacterial acute febrile illness (AFI) in resource-limited settings, specifically in Brazil, Malawi and Gabon.

Design
Multinational, cross-sectional study.

Setting
The study was carried out across multiple primary healthcare facilities, including urban and rural settings, with a total of three participating centres. Recruitment took place from October 2018 to July 2019 in Brazil, May to November 2019 in Gabon and April 2017 to April 2018 in Malawi.

Participants
A total of 1915 participants, including children and adults aged 21–65 years with a fever of≤7 days, were recruited through convenience sampling from outpatient clinics in Brazil, Gabon and Malawi. Individuals with signs of severe illness were excluded. Written consent was obtained from all participants or their guardians.

Intervention
This is not applicable as the study primarily focused on biomarker evaluation without specific therapeutic interventions.

Primary and secondary outcome measures
The primary outcome measure was the ability of each host biomarker to differentiate between bacterial and non-bacterial AFI, as evaluated by area under the receiver operating characteristic (AUROC) curves. Secondary outcomes included the performance of individual biomarkers across the different study sites and in a multivariable setting.

Results
A Kruskal-Wallis test, adjusted by Benjamini-Hochberg, was performed for each biomarker to identify covariates with a significant difference in the distribution of biomarker values. The analysis revealed that country of origin (Brazil, Gabon, Malawi), age, sex and malaria status significantly impacted biomarker distribution (p≤0.001). The most widely known biomarkers, such as white blood cell (WBC) count and C-reactive protein (CRP), demonstrated the best performance in distinguishing between bacterial and non-bacterial infections, with AUROCs reaching up to 0.83 (0.77–0.88) for WBC count and 0.71 (0.59–0.82) for CRP. However, none of the evaluated novel host biomarkers exhibited high performance (AUROC

Background
Prostate cancer (PCa) is the most common male malignancy in the western world. Many men (40%) are diagnosed with localised low or intermediate-risk PCa, which is suitable for active surveillance (AS). AS affords careful monitoring to identify changes in otherwise non-life-threatening cancers. While AS reduces overtreatment (and quality of life impact), long-term compliance can be poor, with many men undergoing radical treatment after starting AS.

Methods and analysis
Finasteride in Active Surveillance for men with low and intermediate-risk prostate cancer (FINESSE) is a prospective, open-label, two-arm, phase 3 trial, in which men with low or intermediate PCa are randomised (1:1) to receive AS with or without finasteride (5 mg once a day for 2 years). Randomisation is stratified by age and PCa risk. AS includes regular prostate-specific antigen testing, MRI scans and the offer of repeat biopsy (at 3 years, or if imaging suggests progression). Additional MRI scans and/or biopsies will be performed for biochemical or clinical indications. We aim to recruit 550 men (aged 50 to 75 years) from up to eight sites. Active outpatient follow-up will be for 3–5 years (depending on date recruited), followed by passive registry-based follow-up for up to 10 years. Primary outcome is adherence to AS. Secondary outcomes include rates and type of disease progression, treatments received (for PCa and benign prostatic enlargement), overall and PCa-specific mortality, an understanding of patients/professionals views of this approach and health-related quality of life. An external panel of experts blinded to allocation will review all AS cessation and progression events. Trial pathologist’s and radiologist’s, blinded to allocation, will review representative cases. Analysis is Intention to Treat.

Ethics and dissemination
The study received Health Research Authority and South-Central Oxford Research Ethics Committee (14/12/2021: 21/SC/0349) and CTA/MHRA (29/12/2021: 21304/0274/001–0001) approvals. Results will be made available to providers and researchers via publicly accessible scientific journals.

Trial registration number
ISRCTN16867955

Introduction
All grade 2/3 gliomas are incurable and at the time of inevitable relapse, patients have significant unmet needs with few effective treatments. This study aims to improve outcomes by molecular profiling of patients at relapse, then matching them with the best available drug based on their molecular profile, maximising the chances of patient benefit while simultaneously testing multiple novel drugs.

Methods and analysis
Low & Anaplastic Grade Glioma Umbrella Study of MOlecular Guided TherapieS (LUMOS-2) will be an international, phase 2, multicentre, open-label, biomarker-directed, umbrella clinical trial for recurrent isocitrate dehydrogenase mutant, histologically grade 2/3 gliomas. Investigational treatment will be assigned based on molecular profiling of contemporaneous tissue obtained at disease relapse using next-generation sequencing. LUMOS-2 will begin with three therapeutic treatment arms: paxalisib, cadonilimab and selinexor. Patient molecular profiles will be assessed by an expert, multidisciplinary Molecular Tumour Advisory Panel. Patients whose molecular profile is considered suitable for a targeted agent like paxalisib will be allocated to that arm, others will be randomised to the available arms of the trial. The primary endpoint is progression-free survival at 6 months. Secondary objectives include assessment of overall survival, response rate, safety and quality of life measures. Two additional therapeutic arms are currently in development.

Ethics and dissemination
Central ethics approval was obtained from the Sydney Local Health District Ethics Review Committee, Royal Prince Alfred Hospital Zone, Sydney, Australia (Approval: 2022/ETH02230). Other clinical sites will provide oversight through local governance processes, including obtaining informed consent from suitable participants. A report describing the results of the study will be submitted to international meetings and peer-reviewed journals.

Trial registration number
ACTRN12623000096651.

Introduction
Low back pain (LBP) is a global health concern. Approximately two-thirds of those who recover from LBP experience a relapse within a year, with many chronic cases encountering acute flare-ups (exacerbation). This systematic review will synthesise and analyse whether physical and/or psychological features can predict recurrent episodes of LBP or exacerbation of pain.

Methods and analysis
This systematic review protocol follows the Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols guidelines. Comprehensive literature searches will be conducted in MEDLINE, EMBASE, APA PsycInfo, PubMed, CINAHL Plus, Web of Science, Scopus and ZETOC, spanning from each database’s inception through to January 2025. Google Scholar and grey literature sources, including OpenGrey, will also be searched to ensure comprehensive coverage. Two independent reviewers will screen titles, abstracts and full texts, assessing the risk of bias with a modified Quality in Prognosis Studies tool. The overall certainty of evidence will be evaluated using an adapted Grading of Recommendations Assessment, Development and Evaluation approach. If sufficient data homogeneity is present, a meta-analysis will be performed; otherwise, findings will be synthesised narratively. The results will identify the ability of physical and/or psychological factors to predict pain recurrence or acute exacerbation in case of persistent non-specific LBP.

Ethics and dissemination
This study protocol does not present any ethical concerns. The findings from the systematic review will be submitted for publication in a peer-reviewed journal and will also be presented at relevant conferences.

PROSPERO registration number
CRD42024599514.

Introduction
Patellofemoral pain affects one-third of adolescents, with most experiencing symptoms into adulthood. Guidelines recommend exercise and foot orthoses based on clinical trials in adults; however, these approaches have been found to be ineffective and have poor adherence in adolescents. ‘Minimalist’ shoes can reduce patellofemoral joint forces in adults; and may therefore be a promising low burden management approach for patellofemoral pain. This article outlines the protocol for a randomised clinical trial (RCT) that aims to determine if minimalist footwear improves pain, function and other symptoms compared with motion control shoes, in adolescents with patellofemoral pain.

Methods and analysis
This is a 3-month, pragmatic, two-arm parallel group, comparative effectiveness, superiority RCT conducted in Melbourne, Australia. We are recruiting 158 participants aged between 12 and 19 years with patellofemoral pain from the community. Following baseline assessment, participants are randomised to receive either minimalist shoes (intervention group) or motion control shoes (control group, given that clinicians typically advocate motion control shoes for patellofemoral pain). Participants choose one pair of shoes in their allocated group from two colour options. They are advised to wear their study shoes for all planned sports and exercise-based activities over the subsequent 3 months and are also advised that they may wear them as much as desired at other times. The primary outcomes are the 3-month change in (1) severity of the worst knee pain experienced over the past week, measured using a Numerical Rating Scale, and (2) the function in sport and play subscale of the Knee Injury and Osteoarthritis Outcome Score for Children. The secondary outcomes include changes in other parameters of knee pain, symptoms, function in daily activities, health-related and knee-related quality of life, global improvement and fear of movement. Other measures include cointervention use, adherence, adverse events, shoe comfort, descriptive characteristics, physical activity levels, footwear characteristics and objective foot measures.

Ethics and dissemination
This study has been approved by the University of Melbourne Greater than Low Risk Human Research Ethics Committee (reference: 2022-25470-35344-4). Written informed consent is obtained from each participant prior to enrolment. The SHoes for Adolescent PatEllofemoral pain trial will provide the first RCT evidence on the efficacy of minimalist shoes compared with motion control shoes in adolescents with patellofemoral pain. Outcomes will be presented at national and international scientific conferences and published in peer-review journals.

Trial registration number
Australian New Zealand Clinical Trials Registry reference: ACTRN12623000042640.

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

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

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

Trial registration number
jRCTs041230110 and jRCTs041230111.

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.

Background
Human milk, especially mother’s own milk (MOM), is vital for newborns and crucial for very low birthweight (VLBW,