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ESMO: scala aggiornata per misurare il beneficio clinico dei trattamenti contro il cancro
L’European Society for Medical Oncology (ESMO) ha pubblicato l’ultima versione della […]
Implications derived from the strengths and weaknesses observed in Irans primary healthcare programmes during the COVID-19 pandemic: a qualitative interview study
Background
The COVID-19 outbreak at the end of 2019 severely impacted global healthcare systems, especially primary healthcare services. This paper aimed to identify the implications derived from the strengths and weaknesses observed in Iran’s primary healthcare (PHC) programmes during the pandemic.
Methods
This was a qualitative study conducted in 2021. 13 semistructured interviews were held with Iranian healthcare policymakers and executive managers, selected via snowball sampling, using the World Health Organization’s analytical framework. Finally, a thematic analysis was conducted on the interview data.
Results
The thematic analysis of the findings yielded five major themes: revision of healthcare financing, redefining education and research in primary healthcare, redefinition of primary healthcare, development of a new model for family medicine, and community engagement.
Conclusion
Addressing vertical inequality in Iran’s healthcare system was delineated to be crucial. Meanwhile, multiple strategies including enhancing family physicians’ knowledge and skills, decentralising decision-making, empowering them and involving communities in healthcare planning were presented to improve PHC and family medicine. Further empirical research is needed.
Characterising physical activity patterns in community-dwelling older adults using digital phenotyping: a 2-week observational study protocol
Introduction
Physical activity (PA) is crucial for older adults’ well-being and mitigating health risks. Encouraging active lifestyles requires a deeper understanding of the factors influencing PA, which conventional approaches often overlook by assuming stability in these determinants over time. However, individual-level determinants fluctuate over time in real-world settings. Digital phenotyping (DP), employing data from personal digital devices, enables continuous, real-time quantification of behaviour in natural settings. This approach offers ecological and dynamic assessments into factors shaping individual PA patterns within their real-world context. This paper presents a study protocol for the DP of PA behaviour among community-dwelling older adults aged 65 years and above.
Methods and analysis
This 2-week multidimensional assessment combines supervised (self-reported questionnaires, clinical assessments) and unsupervised methods (continuous wearable monitoring and ecological momentary assessment (EMA)). Participants will wear a Garmin Vivosmart V.5 watch, capturing 24/7 data on PA intensity, step count and heart rate. EMA will deliver randomised prompts four times a day via the Smartphone Ecological Momentary Assessment3 application, collecting real-time self-reports on physical and mental health, motivation, efficacy and contextual factors. All measurements align with the Behaviour Change Wheel framework, assessing capability, opportunity and motivation. Machine learning will analyse data, employing unsupervised learning (eg, hierarchical clustering) to identify PA behaviour patterns and supervised learning (eg, recurrent neural networks) to predict behavioural influences. Temporal patterns in PA and EMA responses will be explored for intraday and interday variability, with follow-up durations optimised through random sliding window analysis, with statistical significance evaluated in RStudio at a threshold of 0.05.
Ethics and dissemination
The study has been approved by the ethical committee of Hasselt University (B1152023000011). The findings will be presented at scientific conferences and published in a peer-reviewed journal.
Trial registration number
NCT06094374.
Cost-effectiveness of massed versus spaced trauma-focused treatment as first-line treatment for post-traumatic stress disorder in adults with multiple trauma exposure: protocol for a single-blind non-inferiority randomised controlled trial
Introduction
Post-traumatic stress disorder (PTSD) is a serious disorder that burdens individuals and society. The current standard of first-line treatment for PTSD is spaced trauma-focused treatment (S-TFT), involving weekly sessions. While effective, S-TFT may take relatively long to complete, especially in patients exposed to multiple potentially traumatic events (PTEs). Massed trauma-focused treatment (M-TFT), involving increased session frequency, potentially results in faster symptom reduction and restoration of quality of life, as well as in a reduction of societal costs. However, M-TFT is not recommended as first-line treatment. This paper describes the research protocol of a single-blind, multicentre randomised controlled trial (RCT) aimed at investigating: (1) the clinical and cost-effectiveness of M-TFT versus S-TFT in employed, multiply traumatised patients who seek first-line treatment for PTSD and (2) predictive and moderating factors related to treatment response.
Methods and analysis
186 participants are recruited from five centres and will be included if they are ≥18 years old, meet criteria for a Diagnostic and Statistical Manual of Mental Disorders Fifth Edition PTSD diagnosis based on ≥two PTEs, seek treatment for the first time and are employed. Patients with specified comorbid disorders and insufficient Dutch language proficiency are excluded. Participants are randomised to 800 min of either M-TFT or S-TFT. M-TFT consists of two once-weekly preparatory sessions, 10 twice-daily sessions of prolonged exposure, eye movement desensitisation and reprocessing therapy for 2 weeks and two once-weekly closing sessions. S-TFT consists of weekly sessions of one of five evidence-based treatment interventions. Outcomes are assessed at baseline and at 7 weeks, 17 weeks, 6 months and 9 months after baseline. Primary outcomes are clinical effectiveness in terms of PTSD symptom severity and cost-effectiveness based on quality of life measures and societal costs. Data will be analysed with linear mixed models.
Ethics and dissemination
This study protocol was approved by the Medical Ethics Review Board of the Amsterdam University Medical Center (NL86057.018.24). Participants will provide informed consent before enrolment in the trial. Results will be published in peer-reviewed journals and will be released to clinicians, patient groups and the general community.
Trial registration number
This protocol is registered at Overview of Medical Research in the Netherlands (OMON; trial register number 56960) and ClinicalTrials.gov (NCT06700590).
1-year survival in critically ill elderly medical patients treated with a conservative or an invasive approach (OCTO-REVERSE study): a nationwide observational study
Objective
To determine whether an invasive approach is associated with favourable long-term outcomes among elderly medical patients in the intensive care unit (ICU), compared with a conservative approach.
Design
Nationwide observational study (OCTO-REVERSE study) using data prospectively collected in the National French Healthcare Database (covering 99% of the population, 66 million people).
Setting
Comprehensive multicentre study through the linkage of large-scale national registries (including all public or private facilities) from 2013 to 2018 to avoid ambiguities related to the COVID-19 pandemic.
Participants
All non-surgical patients aged 80 years or older admitted to an ICU in France during the period (n=107 014 patients at 822 hospitals).
Outcome measures
The main outcome was the 1-year survival rate. The association of the two approaches with 1-year survival was estimated using a time-dependent Cox model and a propensity score (PS) adapted to time-to-event analysis, yielding the average treatment effect in the treated and extended weighted Kaplan–Meier curves.
Results
107 014 patients were categorised into two groups based on the type of care received: invasive (n=51 680 (48%) received invasive ventilation and/or vasopressor support) or conservative (n=55 334 (52%) received neither). 1-year survival rate was significantly lower in the invasive group than in the conservative group (27% vs 59% estimated with extended time-dependent Kaplan–Meier method). The risk of death in the invasive group remained significantly higher after time-dependent PS weighting (HR 1.64; 95% CI 1.60 to 1.69; p
Investigating biographical post-bariatric surgery uncertainties in the light of changes in bodily practices: a mixed-method, multicentric and longitudinal research protocol
Introduction
The effects of bariatric surgery have largely been studied from a medical viewpoint, seeking to measure changes in anthropometric, physiological or quality-of-life factors after the operation. Few studies, however, have focused on the dynamics of lifestyle changes. Yet we know that changing lifestyle habits—which are often part of the established social configurations at the origin of morbid obesity—is essential for a sustainable recovery from obesity. We also know that the major bodily transformations that occur in the six to twelve months following surgery produce a high degree of biographical uncertainty and affect social interactions. From a sociological perspective, the authors propose to study the processes of disruption and re-establishment of lifestyle habits in the first 24 months following bariatric surgery.
Methods and analysis
The ChiBarAPS study relies on a mixed-method longitudinal survey, comprising three components: qualitative, quantitative, literature and data review. It aims to document three main dimensions, which must be articulated to understand the dynamics of change: (1) the work undertaken by patients on themselves in order to identify and measure the evolutionary effects of surgery, as well as to adapt to them; (2) the experience of using pre- and post-surgery information and support systems, and evaluating their effects on the agency of the people who have undergone surgery; (3) the evolution of social participation and lifestyle habits. The qualitative component concerns a cohort of 30 patients, interviewed in depth (2 hours) on these three dimensions, 6 months, 12 months and 24 months after the operation. The quantitative part uses questionnaires applied to a second group of 200 patients, following the same timeline.
Ethics and dissemination
This study complies with reference methodology MR004 of the French National Data Protection Authority and was registered by the Data Protection Officer of the University of Montpellier on the activity registry of the institution (24 April 2024). Ethics approval has been obtained from the University of Montpellier ethics research board (n°UM2024-037). Informed consent will be obtained from all participants before data collection. The project has received funding from the French National Research Agency (n°ANR-23-CE41-0020-01) from February 2024 to the end of January 2028. The first results of the research will be disseminated from 2026 onwards to researchers, health professionals and patient support organisations. The results of the study will then be published in peer-reviewed scientific journals, both national and international.
Globally applicable solution to hearing loss screening: a diagnostic accuracy study of tablet-based audiometry
Objectives
Hearing loss (HL) affects 20% of the world’s population, with shortages of audiologists and audiometric sound booths unable to meet demand for hearing care services. We aimed to assess the accuracy of tablet-based audiometry (TA) to screen for HL at standard (0.25–8 kHz) and extended high frequencies ( >8 kHz).
Design
Diagnostic accuracy study.
Setting
Two secondary care audiology and ear, nose and throat outpatient clinics in the UK between April 2022 and September 2023.
Participants
Adults aged≥16 years undergoing sound booth audiometry (SBA).
Interventions
TA, hearing-related questionnaires and patient usability questionnaires.
Outcome measures
Sensitivity, specificity and accuracy of TA compared with SBA for detecting HL. Patient usability assessment of TA and SBA.
Results
129 patients were enrolled with 127 patients (254 ears) included in the final analysis. Median age was 43 years (IQR 33–56), 55% (70/127) were women. 76% (96/127) and 68% (86/127) of patients had HL defined by British Society of Audiology (BSA) and American Speech–Language–Hearing Association (ASHA) criteria. Age was significantly associated with HL (p85%, respectively, between 0.25 and 12.5 kHz. In terms of patient usability, TA showed significantly higher scores in attractiveness (p
[Corrigendum] Corrigendum to “Feasibility and acceptability of Autism Adapted Safety Plans: an external pilot randomised controlled trial”
Dr Emma Nielsen was originally acknowledged in the paper. However, on discussion and reflection, and agreement with Dr Nielsen and all co-authors, we have added Dr Nielsen as a co-author in recognition of their contributions as a full-time post-doc during the first eight months of the study to methodology, investigation and project administration.
Sulfadoxine-pyrimethamine alone or with azithromycin for the intermittent preventive treatment of malaria in pregnancy: protocol for a systematic review and meta-analysis
Introduction
Increasing Plasmodium resistance levels to sulfadoxine–pyrimethamine (SP) threaten the effectiveness of intermittent preventive treatment in pregnancy (IPTp) and have prompted the evaluation of alternative strategies. Azithromycin (AZ) could have add-on effects on malaria and treat sexually transmitted infections (STIs), both conditions described as major causes of adverse pregnancy outcomes (APO). Inconsistent findings on the utility of AZ for the prevention of APO were reported; however, thus far, no comprehensive meta-analytic synthesis of data has been published. This review aims to investigate the effects of SP+AZ administered in women as IPTp on the risk of low birth weight in malaria-endemic areas.
Methods and analysis
Eligible studies will be identified through a pre-established search strategy in several electronic databases (Medline, Cochrane Library, Web of Science, EMBASE, WHO International Clinical Trials Registry Platform, ClinicalTrials.gov and AJOL) and will comprise peer-reviewed papers reporting original data on the effects of SP+AZ on the risk of APO. Only randomised controlled trials published until 30 September 2024 in English or French will be included. IPTp with SP+AZ regimens (intervention) will be compared with IPTp with SP alone or with a placebo (control). As primary outcomes, data on the frequency of low birth weight will be collected. Secondary outcomes include the rates of stillbirth, preterm birth, miscarriage and neonatal death. Data will be extracted independently by two reviewers using a predefined extraction form. If the data quality allows for quantitative synthesis, a fixed-effects meta-analysis will be conducted if there is low inter-study heterogeneity. Otherwise, the random-effects meta-analysis will be conducted to take into account uncertainty in pooled estimates that could be due to inter-study heterogeneity. The review protocol was designed according to the Preferred Reporting Items for Systematic Reviews and Meta-analyses Protocols (PRISMA-P) guidelines.
Ethics and dissemination
Ethical clearance is not needed as the data will be from already published studies in which informed consent and ethical approval were obtained by primary investigators. Our dissemination plan includes the publication in a peer-reviewed journal as well as conference presentations.
PROSPERO registration number
CRD42020149592.
Stepped wedge cluster randomised controlled trial to assess the impact of a decision support tool for physical restraint use in intensive care units (ARBORea Study): a study protocol
Introduction
Intensive care units (ICUs) manage patients with or likely to have one or more life-threatening acute organ failures that might require the use of invasive supportive therapies. The use of physical restraint is frequent, with rates up to 50%, and usually initiated to maintain patient safety especially if the patient is agitated. Physical restraints have been associated with delirium, post-traumatic stress disorder and physical injuries while restricting patients’ individual freedom. Moreover, the incidence of invasive therapeutic devices’ self-removal by patients might not be decreased by physical restraint use. No recommendation is available concerning ICU patients and physical restraint management, despite being a daily practice. The main objective is to evaluate whether a strategy aimed at decreasing physical restraint use in ICU patients with that of a strategy based on routine and subjective caregivers’ decision is safe and efficient.
Methods and analysis
ARBORea is a multicentre randomised, stepped-wedge trial testing an innovative, dedicated web-based, multiprofessionally developed, experts validated, nursing management strategy in comparison with standard care. The primary outcome is physical restraint use rate (effectiveness) measured at least every 8 hours and incidents’ rate (tolerance) defined as the rate of incidents attributable to non-compliance, corresponding to the deterioration or self-removal of critical devices, a fall or self-aggressive or heteroaggressive behaviours. Planned enrolment is 4000 ICU adult participants at 20 French academic and non-academic centres. Safety and long-term outcomes will be evaluated.
Ethics and dissemination
Trial results will be reported according to the Consolidated Standards of Reporting Trials 2010 guidelines. Findings will be published in peer-reviewed journals and presented at local, national and international meetings and conferences to publicise and explain the research to clinicians, commissioners and service users. The trial is funded by the French Ministry of Health and has been approved by the French local ethics committee (Comité de Protection des Personnes Sud-Ouest et Outre-Mer 2, Toulouse, France with registration number: 2020-A02904-35).
Trial registration number
(ClinicalTrials.gov) NCT04957238 on 12 July 2021 before first inclusion in study.
Augmentation of trauma-focused psychotherapy for post-traumatic stress disorder: a protocol for a systematic review and meta-analysis
Introduction
Despite the established status of trauma-focused psychotherapy (TFP) as a first-line treatment for post-traumatic stress disorder (PTSD), a substantial proportion of individuals do not achieve clinically significant improvement or discontinue treatment. Exploring augmentation strategies to enhance treatment outcomes is essential to reduce the overall burden PTSD puts on individuals and society. This protocol outlines a systematic review and meta-analysis of randomised controlled trials (RCTs) evaluating the efficacy of non-pharmacological augmentation strategies in addition to TFP for PTSD treatment.
Methods and Analysis
We comprehensively searched PubMed, Embase, CENTRAL, PTSDpubs, PsycArticles, PsycINFO, PSYNDEX and CINAHL for RCTs without restrictions on publication dates or languages in October 2024. Study screening is currently ongoing. Additionally, we will perform forward and backward searches of the included studies and relevant reviews. Two reviewers will independently screen and select studies, extract data and assess the risk of bias. We will conduct a narrative review to qualitatively synthesise data and a meta-analysis to quantitatively compare the treatment efficacy of augmented TFP with TFP alone or TFP plus placebo. Primary outcomes will be both symptom severity and response rates. The secondary outcome will be dropout rates. We will explore sources of between-study heterogeneity and potential moderators through subgroup and meta-regression analyses. We will assess the overall quality of the included studies with the Grading of Recommendations Assessment, Development, and Evaluation system.
Ethics and dissemination
Ethical approval is not required. We intend to publish results in a peer-reviewed journal and provide materials and data through the Open Science Framework.
PROSPERO registration number
CRD42024549435.
Care of Patients With Chronic Venous Disease of the Legs
This JAMA Clinical Guidelines Synopsis summarizes the 2022-2023 recommendations on evaluation and management of chronic venous disease of the lower extremities from the Society for Vascular Surgery, American Venous Forum, and American Vein and Lymphatic Society.
Changes in medical student attendance at in-person teaching sessions: a systematic review
Introduction
The COVID-19 pandemic has had a significant impact on medical education, with many institutions shifting to online learning to ensure the safety of students and staff. However, there appears to be a decline in in-person attendance at medical schools across the UK and worldwide following the relaxation of social distancing rules and the reinstatement of in-person teaching. Importantly, this trend was also observed before the pandemic. While reflected within the literature, there is currently no systematic review describing these changes. We aim to find out how medical students’ attendance is changing as documented within the literature and its impact on their educational outcomes.
Methods
This systematic review followed the guidelines of the Centre of Research and Dissemination, Moose and Preferred Reporting Items for Systematic Reviews and Meta-Analyses. We searched the major databases of Medline via Ovid, Embase via Ovid, Scopus, Web of Science, British Education Index via EBSCOhost and ERIC via EBSCOhost in September 2023. Two reviewers independently screened each paper and extracted the data, with a third reviewer for dispute resolution. All studies reporting on medical students from various universities, both graduate and undergraduate, and describing changes in attendance and/or students’ educational outcomes were included. Risk of bias in individual studies was assessed using the Agency for Healthcare Research and Quality tool. A narrative synthesis of the findings from all included studies was done.
Results
12 papers were included in the analysis. Primary aim: Of the eight papers that measured attendance data over more than one academic year, only one paper demonstrated a statistically significant decrease while one paper demonstrated a statistically significant increase in attendance over the observational period. Other papers either did not perform statistical tests or did not demonstrate statistical significance. Secondary aims: Most papers showed a general positive correlation between attendance and educational outcomes. No studies explicitly explored reasons for changes in attendance seen. Only one paper outlined a possible strategy to address changes in attendance, a mandatory attendance policy, which has mixed outcomes.
Discussion
Despite widespread anecdotally reported attendance decline post-COVID-19, overall, there was no consistent change in attendance noted. However, there was a large heterogeneity in the studies included. Further research is required to elucidate trends in attendance and its impact on medical education.
Progress towards prevention of suicide in India by improving print media reporting of suicide news: a repeat content analysis study in Tamil Nadu
Objectives
Suicide rates in India are among the highest in the world, with the most recent suicide death rate estimates ranging between 18 and 21 deaths per 100 000 population (compared with the global average of 11/100 000). Responsible media reporting of suicide is one of the few evidence-based population-level suicide prevention interventions. Reports of recent suicides are a routine daily feature in major newspapers in India, and the reporting style carries many concerning features. In 2019, the Press Council of India adopted the WHO media guidelines, yet there has been no investigation as to whether this guidance is being followed. The aim of this paper was to systematically investigate whether the quality of print media reports of suicides has changed since the adoption of media guidelines for suicide reporting in India.
Design
We used content analysis to assess the quality of suicide reporting against WHO guidelines in nine of the most highly read daily newspapers in the southern state of Tamil Nadu between June and December 2016 and June and December 2023. Our analyses of changes in reporting were based on a sample of 1681 print newspaper articles from 2016 and 512 print newspaper articles from 2023. Two-tailed t-tests and proportion tests on aggregate means and frequencies assessed whether the reporting characteristics had changed between 2016 and 2023.
Results
There were small yet statistically discernible reductions in the proportion of articles containing various potentially harmful reporting characteristics, such as articles placed on the front page (4.9–1.8%, p=0.002) and articles mentioning the suicide method (92.7–86.5%, p
Epidemiology of disability and access to disability support and rehabilitation services in India: a secondary data analysis of the National Sample Survey (2018)
Objective
The aim of this study was to examine the epidemiology of disability in India and assess access to disability support and rehabilitation services by people with disability (PWD).
Design
This study is a secondary analysis of data from the 76th round of the National Sample Survey (2018), focusing on disability in India.
Setting
The survey employed a stratified two-stage sampling design based on Census 2011, covering all states and union territories of India. Villages and urban blocks were selected in the first stage, while households were chosen in the second stage across rural and urban areas.
Participants
The survey included data from a population of 576 796 individuals residing in 118 152 households from 8992 village/urban blocks (5378 rural villages and 3614 urban blocks). The analysis focused on 107 125 individuals (61 707 male and 45 305 female) who reported at least one disability.
Outcome measures
The primary outcome was ‘any disability’. Secondary outcomes included access to disability support and rehabilitation services, which assessed difficulties in accessing public buildings and transport, loss of employment after disability, availability of government support, enrolment in special schools, and possession of a disability certificate.
Results
The overall weighted disability prevalence was 2.2%, with significant disparities across sociodemographic characteristics. Among PWD, 45.9% of those who acquired disability after birth were aged between 15 years and 59 years, and 20.8% received no government aid. About 40% of PWD struggled to use public transport, and 57.7% had difficulties accessing public buildings. Additionally, 60.7% reported job loss due to disability, and 69.6% lacked a disability certificate.
Conclusion
This study highlights disparities faced by PWD in accessing disability support and rehabilitation services. There is an urgent need for concerted efforts to minimise such experiences. This will help us enhance the well-being and participation of PWD and empower them to contribute to society with their true potential.