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To the Editor We have some comments about the recent article that reported the efficacy of low-dose aspirin in reducing hepatic fat quantity in patients with metabolic dysfunction–associated steatotic liver disease (MASLD).
In Reply We thank Dr Fujieda, Ms Yu, and Dr Tu and colleagues for their Letters about our randomized clinical trial of aspirin for the treatment of liver fat in patients with MASLD without cirrhosis. We agree that our study findings of reduced liver fat content and reductions in markers of liver inflammation and fibrosis with aspirin, compared with placebo, warrant further study in larger randomized trials with longer duration of follow-up and with inclusion of both histological and clinical end points, as we highlighted in the article. Nevertheless, we would emphasize that liver fat content quantified by magnetic resonance imaging is a well-established and accepted end point in early-phase MASLD clinical trials, and reducing hepatic fat by 30 percentage points or greater is widely considered a meaningful treatment effect, based on corresponding improvements in steatohepatitis and fibrosis. Furthermore, a 3- to 6-month intervention represents a reasonable and appropriate duration for most early-phase MASLD clinical trials, as it provides sufficient time to ascertain meaningful changes in MASLD histology while minimizing potential risks from a novel therapy. Thus, our findings demonstrating the efficacy of aspirin in reversing liver fat and improving markers of inflammation and fibrosis after 6 months of treatment provide a strong preliminary foundation for future, larger-scale clinical trials with longer follow-up time and with both histological and clinical end points.
To the Editor A recent clinical trial of the effect of low-dose aspirin on MASLD lasted 6 months and demonstrated that daily low-dose aspirin decreased hepatic fat content compared with placebo. However, I have some concerns about the applicability and long-term consequences of these results.
To the Editor Although a recent study about the therapeutic potential of aspirin in managing MASLD without cirrhosis provided valuable insights, we have several concerns about the study’s design and interpretation of results.
Objectives
Studies usually investigate a limited number or a predefined combinations of risk factors for sickness absence in employees with pain. We examined frequently occurring combinations across a wide range of work-related factors and pain perceptions.
Design
Cross-sectional study.
Setting
Belgian companies that are under supervision of IDEWE, an external service for prevention and protection at work.
Participants
In total, 249 employees experiencing pain for at least 6 weeks were included and filled out an online survey.
Outcomes
Latent profile analysis was used to differentiate profiles of work-related factors (physical demands, workload, social support and autonomy) and pain perceptions (catastrophising, fear-avoidance beliefs and pain acceptance). Subsequently, profiles were compared on sociodemographics (age, gender, level of education, work arrangement, duration of complaints, multisite pain and sickness absence in the previous year) and predictors of sickness absence (behavioural intention and perceived behavioural control).
Results
Four profiles were identified. Profile 1 (38.2%) had favourable scores and profile 4 (14.9%) unfavourable scores across all indicators. Profile 2 (33.3%) had relatively high physical demands, moderate autonomy levels and favourable scores on the other indicators. Profile 3 (13.7%) showed relatively low physical demands, moderate autonomy levels, but unfavourable scores on the other indicators. Predictors of profiles were age (OR 0.93 and 95% CI (0.89 to 0.98)), level of education (OR 0.28 and 95% CI (0.1 to 0.79)) and duration of sickness absence in the previous year (OR 2.29 and 95% CI (0.89 to 5.88)). Significant differences were observed in behavioural intention (2=8.92, p=0.030) and perceived behavioural control (2=12.37, p=0.006) across the four profiles.
Conclusion
This study highlights the significance of considering the interplay between work-related factors and pain perceptions in employees. Unfavourable scores on a single work factor might not translate into maladaptive pain perceptions or subsequent sickness absence, if mitigating factors are in place. Special attention must be devoted to employees dealing with unfavourable working conditions along with maladaptive pain perceptions. In this context, social support emerges as an important factor influencing sickness absence.
Introduction
Sesame allergy, though with low prevalence, can result in severe, potentially life-threatening reactions and poses challenges in allergen avoidance due to hidden sources. In the majority of patients, sesame allergy persists and there is currently no effective long-term treatment available. Therefore, oral immunotherapy (OIT) is a promising alternative approach to managing sesame allergy. In this study protocol, we present a randomised controlled trial evaluating the efficacy and safety of OIT with low-dose sesame protein in paediatric patients. The study’s aim is to compare OIT with a 300 mg maintenance dose of sesame protein against controls.
Methods and analysis
39 participants aged 3–17 with IgE-mediated sesame allergy confirmed by oral food challenge will be enrolled into the study. The trial will be conducted at the Paediatric Hospital of the Medical University of Warsaw, Poland. The study comprises two arms—sesame OIT and control. In the sesame OIT group, interventions will be administered once daily for up to 18 months. During the first phase, the dose will be escalated every 2–4 weeks, and in the second phase, the maintenance dose of 300 mg sesame protein will continue for 3 months. Members of the control group will receive standard treatment, which includes an elimination diet and will remain under observation for 1 year. The primary outcome is the proportion of participants tolerating a single dose of 4000 mg of sesame protein during the final oral food challenge in the experimental group versus the control group. Secondary outcomes assess adverse events, changes in immunological parameters and the maximum tolerated doses of sesame protein in each group.
Ethics and dissemination
This study has been approved by the Ethics Committee of the Medical University of Warsaw (approval number: KB/269/2023). Results will be published in peer-reviewed journals and disseminated via presentations at international conferences.
Trial registration number
NCT06261554.
Introduction
Chronic pain increases the risk of prescription opioid misuse or opioid use disorder (OUD). Non-pharmacological treatments are needed to dually address pain and opioid risks. The purpose of the Mobile and Online-Based Interventions to Lessen Pain (MOBILE Relief) study is to compare a one-session, video-based, on-demand digital pain relief skills intervention for chronic pain (‘Empowered Relief’ (ER); tailored to people at risk for opioid misuse or with opioid misuse/OUD) to a one-session digital health education intervention (‘Living Better’; no pain management skills).
Methods and analysis
MOBILE Relief is an international online randomised controlled clinical trial. Study participants are adults with chronic, non-cancer pain (≥6 months) with daily pain intensity ≥3/10, taking ≥10 morphine equivalent daily dose and score ≥6 on the Current Opioid Misuse Measure. Participants are recruited through clinician referrals and clinic advertisements. Study procedures include electronic eligibility screening, informed consent, automated 1:1 randomisation to the treatment group, baseline measures, receipt of assigned digital treatment and six post-treatment surveys spanning 3 months. Study staff will call participants at baseline and 1-month and 3 months post-treatment to verify the opioid prescription. The main statistical analyses will include analysis of covariance and mixed effects model for repeated measurements regression.
Main outcomes
Primary outcomes are self-reported pain catastrophising, pain intensity, pain interference, opioid craving and opioid misuse at 1-month and 3 months post-treatment. We will determine the feasibility of ER (≥50% participant engagement, ≥70% treatment appraisal ratings). We hypothesise the ER group will be superior to the Living Better group in the reduction of multiprimary pain outcomes at 1-month post-treatment and opioid outcomes at 1-month and 3 months post-treatment.
Ethics and dissemination
The study protocol was approved by the Stanford University School of Medicine Institutional Review Board (IRB 61643). We will publish results in peer-reviewed journals; National Institute of Drug Abuse (funder) and MOBILE Relief participants will receive result summaries.
Trial registration number
NCT05152134.
Introduction
Many types of prostate cancer present minimal risk to a man’s lifespan or well-being, but existing terminology makes it difficult for men to distinguish these from high-risk prostate cancers. This study aims to explore whether using an alternative label for low-risk prostate cancer influences management choice and anxiety levels among Australian men and their partners.
Methods and analysis
We will run two separate studies for Australian men and Australian women with a male partner. Both studies are between-subjects factorial (3×2) randomised online hypothetical experiments. Following consent, eligible participants will be randomised 1:1:1 to three labels: ‘low-risk prostate cancer, Gleason Group 1’, ‘low-risk prostate neoplasm’ or ‘low-risk prostate lesion’. Participants will then undergo a second randomisation step with 1:1 allocation to the provision of detailed information on the benefits and harms of different management choices versus the provision of less detailed information about management choices. The required sample sizes are 1290 men and 1410 women. The primary outcome is the participant choice of their preferred management strategy: no immediate treatment (prostate-specific antigen (PSA)-based monitoring or active surveillance using PSA, MRI, biopsy with delayed treatment for disease progression) versus immediate treatment (prostatectomy or radiation therapy). Secondary outcomes include preferred management choice (from the four options listed above), diagnosis anxiety, management choice anxiety and management choice at a later time point (for participants who initially choose a monitoring strategy).
Ethics and dissemination
Ethics approval has been received from The University of Sydney Human Research Ethics Committee (2023/572). The results of the study will be published in a peer-reviewed medical journal and a plain language summary of the findings will be shared on the Wiser Healthcare publications page http://www.wiserhealthcare.org.au/category/publications/
Trial registration numbers
Australian New Zealand Clinical Trials Registry (ID 386701 and 386889).
Background
Coronary heart disease (CHD) is the most prevalent type of cardiovascular disease in Iran. This study aims to investigate the estimation and determinants of direct hospitalisation cost for patients with CHD in Iranian hospitals.
Methods
We identified patients with CHD in Iran in 2019–2020. Data were gathered from the Iran Health Insurance Organisation information systems and the Ministry of Health and Medical Education. This was a cross-sectional prevalence-based study. Generalised linear models were used to find the determinants of hospitalisation cost for patients with CHD. A total of 86 834 patients suffering from CHD were studied.
Results
Mean hospitalisation cost per CHD patient was US$382.90±US$500.72 while the mean daily hospitalisation cost per CHD patient was US$89.71±US$89.99. In-hospital mortality of CHD was 2.52%. Hospitalisation accommodation and medications had the highest share of hospitalisation costs (25.59% and 22.63%, respectively). Men spent 1.12 (95% CI 1.11 to 1.13) times more on hospitalisation costs compared with women, and individuals aged 60 to 69 had hospitalisation costs 1.04 (95% CI 1.02 to 1.06) times higher than those in the 0–49 age range. Patients insured by the Iranian Fund have significantly higher costs 1.17 (95% CI 1.14 to 1.19) than the Rural fund. Hospitalisation costs for patients with CHD who received surgery and angiography were significantly 2.36 (95% CI 2.30 to 2.43) times higher than for patients who did not undergo surgery and angiography.
Conclusion
Applying CHD prevention strategies for men and the middle-aged population (50–70 years) is strongly recommended. Prudent use and prescribing of medications will be helpful to reduce hospitalisation cost.
Objective
Low birth weight (LBW) is an important indicator of newborn health and can have long-term implications for a child’s development. Spatial exploratory analysis provides a toolkit to gain insight into inequalities in LBW. Few studies in Ghana have explored the spatial distribution of LBW to understand the extent of the problem geographically. This study explores individual and cluster-level distributions of LBW using spatial exploration components for common determinants from nationally representative survey data.
Design
We used data from the 2017 Ghana Maternal Health Survey and conducted individual-level and cluster-level analyses of LBW with place and zone of residence in both bivariate and multivariate analyses. By incorporating spatial and survey designs methodology, logistic and Poisson regression models were used to model LBW.
Setting
Ghana.
Participants
A total of 4127 women aged between 15 and 49 years were included in the individual-level analysis and 864 clusters corresponding to birth weight.
Primary and secondary outcome measures
Individual and cluster-level distribution for LBW using spatial components for common determinants.
Results
In the individual-level analysis, place and zone of residence were significantly associated with LBW in the bivariate model but not in a multivariate model. Hotspot analysis indicated the presence of LBW clusters in the middle and northern zones of Ghana. Compared with rural areas, clusters in urban areas had significantly lower LBW (p=0.017). Clusters in the northern zone were significantly associated with higher LBW (p=0.018) compared with the coastal zones.
Conclusion
Our findings from choropleth hotspot maps suggest LBW clusters in Ghana’s northern and middle zones. Disparities between the rural and urban continuum require specific attention to bridge the healthcare system gap for Ghana’s northern and middle zones.
Objectives
This study investigated the association of fear of falling with performance-based physical function and low back pain (LBP) among older adults.
Design
Cross-sectional study.
Setting
Participants were selected via convenient sampling from Iran University orthopaedic and/or physiotherapy outpatient clinics, between March 2022 and April 2023.
Participants
140 subjects with and without LBP, aged over 60 years, were included.
Outcome measures
The Falls Efficacy Scale International was used to measure fear of falling. A baseline questionnaire inquired about LBP. Participants performed the Timed Up and Go, 30 s Sit-To-Stand (30s-STS), single leg stance with open and closed eyes and gait speed tests to assess performance-based physical function. Demographic variables including age, gender and body mass index were considered as potential covariates. Bivariate and multivariable linear regression analyses were used to investigate the associations.
Results
A significant association between fear of falling and the 30s-STS test score (β=–0.30, 95% CI –1.27 to –0.28; p=0.00) and the sex (β=0.31, 95% CI 1.53 to 4.83; p=0.00) was confirmed in multivariable analyses. LBP and other performance-based physical function tests were not associated with a fear of falling.
Conclusion
Fear of falling was significantly associated with lower extremity muscle function, measured by the 30s-STS test and female gender. Older adults with a fear of falling could benefit from interventions that improve lower extremity muscle function. Also, the observed association between the fear of falling and the female sex confirms the need for effective interventions to reduce the fear of falling among older women.
Introduction
Chronic non-specific low back pain (CNLBP) is among the most common musculoskeletal system conditions reported worldwide; however, few studies are available from low- and middle-income countries (LMICs). Self-management is a set of tasks performed by the patient aiming at managing their symptoms and interference in activities, mood and relationships due to pain. A physiotherapy-guided self-management programme (SMP) following a biopsychosocial approach has been reported as effective and affordable in the management of CNLBP in high-income countries. The objective of this systematic review is to determine the overall effectiveness of SMPs for adults with CNLBP in LMICs.
Methods and analysis
In this systematic review, the Preferred Reporting Items for Systematic Reviews and Meta-Analyses-Protocol (PRISMA-P) guidelines will be followed. A three-step search strategy will be used to search the electronic databases (PubMed, MEDLINE, SPORTDiscus, Scopus and CINAHL, Academic Search Complete and PEDro) for randomised controlled trials assessing the effectiveness of physiotherapy-guided self-management for CNLBP among adult participants in LMICs. The processes of screening search results for eligible studies, extracting data from included studies and appraising will be done independently by at least two review authors. Random effects meta-analysis will be used to synthesise results and heterogeneity will be assessed using the I2 test statistic and 2 test.
Ethics and dissemination
Ethics clearance was obtained for the broader PhD study on the development of a physiotherapy-guided SMP for adult people with CNLBP in Limpopo Province, South Africa. The results of the manuscript for this protocol will be published in peer-reviewed journals and also presented at conferences, symposia, and congresses.
PROSPERO registration number
CRD42023399572.
This case series investigates the recurrence rate of melanoma in situ treated with a 5-mm margin in low-risk body sites.
Introduction
Many individuals receiving outpatient physical therapy have musculoskeletal pain and up to one-third use prescription opioids. The impact of physical therapist-led mindfulness-based interventions integrated with evidence-based physical therapy (I-EPT) to manage patients with chronic musculoskeletal pain and long-term opioid treatment has not been elucidated. This project evaluates the feasibility of conducting a cluster randomised trial to test the effectiveness of I-EPT.
Methods and analysis
Study 1 aim: Refine and manualise the I-EPT treatment protocol. Our approach will use semistructured interviews of patients and physical therapists to refine an I-EPT training manual. Study 2 aim: Evaluate different intensities of physical therapist training programmes for the refined I-EPT treatment protocol. Physical therapists will be randomised 1:1:1 to high-intensity training (HighIT), low-IT (LowIT) training and no training arms. Following training, competency in the provision of I-EPT (LowIT and HighIT groups) will be assessed using standardised patient simulations. Study 3 aim: Evaluate the feasibility of the I-EPT intervention across domains of the Reach, Effectiveness, Adoption, Implementation, Maintenance implementation framework. The refined I-EPT treatment protocol will be tested in two different health systems with 90 patients managed by the randomised physical therapists. The coprimary endpoints for study 3 are the proportions of the Pain, Enjoyment of Life and General Activity Scale and the Timeline Followback for opioid use/dose collected at 12 weeks.
Ethics and dissemination
Ethics approval for the study was obtained from the University of Utah, University of Florida and Florida State University Institutional Review Boards. Informed consent is required for participant enrolment in all phases of this project. On completion, study data will be made available in compliance with NIH data sharing policies.
Trial registration number
NCT05875207.
Annals of Internal Medicine, Ahead of Print.
Annals of Internal Medicine, Volume 177, Issue 9, Page 1145-1156, September 2024.
