Search Results for: GPG: Versione 5.7.5 (Novembre 2021)

Background
Recent studies showed an increase in neuroendocrine neoplasms, especially for the digestive tract. Several risk factors have been suggested to explain this increase, including a family history of cancer, tobacco smoking, alcohol consumption and metabolic disorders such as diabetes and obesity. Another risk factor may be depressive disorders, which could increase the risk of neuroendocrine neoplasms either directly or mediated through associated risk behaviours and/or antidepressant medication. Here, we outline the design of our study to identify the risk factors for neuroendocrine neoplasms in Germany.

Methods and analysis
A case–control study of the resident population of Bavaria, the second most populous federal state in Germany, based on a record linkage of data from the Bavarian Cancer Registry and data from the Bavarian Association of Statutory Health Insurance Accredited Physicians. Cases have a diagnosis of a malignant neuroendocrine neoplasm, either of the bronchopulmonary system or the gastroenteropancreatic system, in the period from 2021 to 2023. Controls are sampled from the non-cases and matched on sex, birth year (in 5-year intervals) and time of diagnosis (by calendar quarter). Risk factor prevalence of cases and controls is assessed on the basis of assured outpatient diagnoses, that is, diagnoses documented in at least 2 out of 4 consecutive quarters in the 16 quarters preceding the diagnosis of a neuroendocrine neoplasm. The analysis uses conditional logistic regression to estimate ORs and 95% CIs.

Ethics and dissemination
This study protocol was approved by the Ethics Committee of the Bavarian State Chamber of Physicians (reference number: 24008). Approval by the supervisory authority has been obtained from the Bavarian State Ministry of Health, Care, and Prevention (reference number: G35h-A1080-2023/20-2) and also the Bavarian Data Protection Commissioner stated to have no concerns after presentation of the study protocol (reference number: DSB/7-692/1-275). The results of the case–control study will be presented at national as well as international conferences and be published in the form of scientific articles in peer-reviewed journals.

Trial registration number
NCT06282016.

Introduction
Recessive dystrophic epidermolysis bullosa (RDEB) is a severe genetic mucocutaneous fragility disorder characterised by chronic blistering, slow wound healing and increased risk of squamous cell carcinoma. Current management options are very limited.

Methods
This is a randomised (1:1), placebo-controlled, double-blinded crossover (A/B) trial with an internal phase I dose de-escalation (4+5 design) in the first 3 months and a 12-month continued treatment follow-on open-label study if 3-month outcome data from the crossover trial indicate safe and beneficial effects. RDEB is a rare condition, so we expect to recruit a maximum of 36 participants based on feasibility and not formal power considerations. Participants aged >6 months and

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.

Background
Governments used travel bans during the COVID-19 pandemic to limit the introduction of new variant of concern (VoC). In the Netherlands, direct flights from South Africa were banned from 26 November 2021 onwards to curb Omicron (B.1.1.529) importation.

Objectives
This study retrospectively evaluated the effect of the South African travel ban and the timing of its implementation on subsequent Omicron infections in the Netherlands and, in order to help inform future decision-making, assessed alternative scenarios in which the reproduction number (Re) and volume of indirectly imported cases were varied.

Design
Descriptive analysis and modelling study.

Outcome measure
Time (days) from 26 November 2021 to reach 10 000 cumulative Omicron infections in the Netherlands.

Methods
To benchmark the direct importation rate of Omicron from South Africa, we used the proportion (n/N, %) of passengers arriving on two direct flights from South Africa to the Netherlands on 26 November 2021 with a positive PCR sequencing result for Omicron VoC infection. We scaled the number of directly-imported Omicron infections before and after the travel ban to the incidence in South Africa. We assumed that 10% of all cases continued to arrive via indirect routes, a ‘failure rate’ of 2% (ie, incoming Dutch citizens not adhering to quarantine on arrival) and an effective reproduction number (Re) of Omicron of 1.3. In subsequent analyses, we varied, within plausible limits, the Re (1.1–2.0) and proportion of indirectly-imported cases (0–20%).

Results
Compared with no travel ban, the travel ban achieved a 14-day delay in reaching 10 000 Omicron cases, with an additional day of delay if initiated 2 days earlier. If all indirect importation had been prevented (eg, European-wide travel ban), a 21-day delay could have been achieved. The travel ban’s effect was negligible if Re was ≥2.0 and with a greater volume of ongoing importation.

Conclusions
Travel bans can delay the calendar timing of an outbreak but are substantially less effective for pathogens where importation cannot be fully controlled and tracing every imported case is unfeasible. When facing future disease outbreaks, we urge policy-makers to critically weigh up benefits against the known socioeconomic drawbacks of international travel restrictions.

Purpose
The Dutch Head and Neck Audit–Oral Cavity (DHNA-OC) cohort was collected to study the quality of care, current treatment and survival for oral cavity cancer (OCC) across all hospitals treating head and neck cancer (HNC) in the Netherlands.

Patients
The DHNA-OC is a registry-based national cohort of 2545 first primary OCC patients treated with curative intent between 2018 and 2021. All 14 HNC hospitals in the Netherlands contributed, guaranteeing national coverage. The DHNA-OC cohort is an elaborate dataset including variables on patient and tumour characteristics, treatment, complications, recurrence rates and survival.

Findings to date
The median age at diagnosis was 67 years and most tumours were early stage (cT1 in 32% and cT2 in 31%). Tongue tumours were most common, and surgery was performed in 91.3% of the patients. The number of included patients per hospital varied from 82 to 367. The proportion of advanced tumour stage varied significantly between hospitals. Substantial data completeness was acquired with only two variables exceeding 10% missing (comorbidities and performance score).

Future plans
The DHNA-OC cohort will be used to study benchmarking of and current knowledge gaps in OCC care. Collaboration with other institutions or national/regional databases is highly encouraged. Some examples of planned studies are the assessment of hospital variation in outcome indicators for surgery and population-based treatment effects. The results of these studies will be used to identify best practices and continue improving the quality of care. Longitudinal cohort follow-up and enrolment will continue prospectively.

Introduction
Breast cancer is the most common form of cancer in women. A considerable number of women with breast cancer who have been treated with chemotherapy subsequently develop neurological symptoms such as concentration and memory difficulties (also known as ‘chemobrain’). Currently, there are no validated therapeutic approaches available to treat these symptoms. Cognitive training holds the potential to counteract cognitive impairment. Combining cognitive training with concurrent transcranial direct current stimulation (tDCS) could enhance and maintain the effects of this training, potentially providing a new approach to treat post-chemotherapy subjective cognitive impairment (PCSCI). With this study, we aim to investigate the effects of multi-session tDCS over the left dorsolateral prefrontal cortex in combination with cognitive training on cognition and quality of life in women with PCSCI.

Methods and analysis
The Neuromod-PCSCI trial is a monocentric, randomised, double-blind, placebo-controlled study. Fifty-two women with PCSCI after breast cancer therapy will receive a 3-week tDCS-assisted cognitive training with anodal tDCS over the left dorsolateral prefrontal cortex (target intervention), compared with cognitive training plus sham tDCS (control intervention). Cognitive training will consist of a letter updating task. Primary outcome will be the performance in an untrained task (n-back task) after training. In addition, feasibility, safety and tolerability, as well as quality of life and performance in additional untrained tasks will be investigated. A follow-up visit will be performed 1 month after intervention to assess possible long-term effects. In an exploratory approach, structural and functional MRI will be acquired before the intervention and at post-intervention to identify possible neural predictors for successful intervention.

Ethics and dissemination
Ethical approval was granted by the ethics committee of the University Medicine Greifswald (BB236/20). Results will be available through publications in peer-reviewed journals and presentations at national and international conferences.

Trial registration number
ClinicalTrials.gov; NCT04817566, registered on 26 March 2021.

Objectives
To examine how relationships between physicians, pharmacists and patients associate with generic drug (GE) utilisation in Japan’s healthcare system.

Design
Observational study using longitudinal medical claims from April 2015 to March 2021.

Setting
Pharmacies across Japan serving beneficiaries of the National Health Insurance Association.

Participants
69 395 pharmacies, resulting in 322 097 pharmacy-year observations.

Main outcome measures
Quantity share of GEs dispensed by pharmacies.

Results
Higher hospital prescription concentration was consistently associated with increased GE usage (1.1–2.3 percentage points higher for moderate to very high concentrations compared with low). The relationship between patient prescription concentration and GE usage varied, showing a positive association (0.3–0.6 percentage points higher) overall, but negative in settings with low hospital concentration. Smaller pharmacies exhibited a stronger positive association between hospital concentration and GE usage, while larger pharmacies and those in less urbanised areas showed a stronger positive association between patient concentration and GE usage.

Conclusions
This study reveals that pharmacy-stakeholder relationships significantly influence GE utilisation in Japan’s healthcare system. Our findings demonstrate that hospital-pharmacy relationships consistently drive generic usage, while patient-pharmacy relationships show contextual effectiveness. By measuring these relationships through concentration rates, we provide evidence that stakeholder interactions may affect medication dispensing decisions. These findings suggest that policies promoting GEs may benefit from considering the specific characteristics of pharmacies and their existing relationships with hospitals and patients. These insights can inform more effective policy design for GE promotion across different healthcare contexts.

Objective
A growing body of evidence points to a role for herpesviruses in the development of Alzheimer’s disease (AD) and a reduced risk of AD among patients receiving antiherpetic medications. We investigated the association between herpes simplex virus type 1 (HSV-1) and AD using real-world data (RWD) from USA.

Design
In a matched case–control study, patients with AD aged ≥50 years diagnosed between 2006 and 2021 were identified from the IQVIA PharMetrics Plus claims database. Controls were matched in a 1:1 ratio with subjects with AD on age, sex, region, database entry year and healthcare visit numbers.

Results
The study included 344 628 AD case–control pairs. History of HSV-1 diagnosis was present in 1507 (0.44%) patients with AD compared with 823 (0.24%) controls. HSV-1 diagnosis was found to be associated with AD (adjusted OR 1.80; 95% CI 1.65 to 1.96). Patients with HSV-1 who used antiherpetics were less likely to develop AD compared with those who did not use antiherpetics (adjusted HR 0.83, 95% CI 0.74 to 0.92).

Conclusions
Findings from this large RWD study implicate HSV-1 in the development of AD and highlight antiherpetic therapies as potentially protective for AD and related dementia.

The Research Letter titled “Symptoms and Functional Impairment Assessed 8 Months After Mild COVID-19 Among Health Care Workers” that was published in the May 18, 2021, print issue of JAMA has been corrected to update Dr Phillipson’s affiliation.

Objective
There is limited evidence on the economic implications of assessing patients’ access to personalised treatments through Comprehensive Genomic Profiling (CGP) and Molecular Tumour Board (MTB), prompting the need to analyse their impact on the cost of the cancer diagnostic journey (from hospital admission to MTB evaluation) and accessibility to personalised therapies.

Design
Retrospective observational cohort.

Setting
Patients discussed from April 2020 to September 2021 by the institutional MTB operating at Fondazione IRCCS Istituto Nazionale Tumori of Milan, an Italian centre of excellence in oncology pertaining to the national health system.

Participants
676 patients focused on: non-small cell lung cancer (NSCLC), cholangiocarcinoma (CCA), pancreatic carcinoma (PC) and gastro-oesophageal carcinoma (GEC). We defined two different scenarios: (1) patients tested with small Next-Generation Sequencing (NGS) panels (≤60 biomarkers) vs (2) patients tested with comprehensive panels ( >60 biomarkers).

Main outcomes and measures
We measured (1) patients’ eligibility to personalised therapies based on genomic data obtained using targeted somatic NGS panels, (2) MTB cost and the overall diagnostic journey cost and (3) the cost to find a patient eligible to access personalised treatments.

Results
Tumour profiling with comprehensive NGS panels improved patients’ eligibility to personalised therapies compared with small panels (NSCLC: 39% comprehensive panel vs 37% small panel; CCA: 43% vs 17%; PC: 35% vs 3%; GEC: 40% vs 0%). The overall diagnostic journey cost per patient was between 3.2K and 7.4K (NSCLC: 7.4K comprehensive panel vs 6.4K small panel; CCA: 4.9K vs 3.7K; PC: 5.8K vs 4.5K; GEC: 4.2K vs 3.2K). MTB discussion accounted for only 2–3% of the diagnostic journey cost per patient (around 113/patient). The cost to find patient eligible for personalised treatments varied significantly according to panel size and tumour setting (NSCLC: 5K comprehensive panel vs 2.8K small panel; CCA: 4.4K vs 4.4K; PC: 5.5K vs 27K; GEC: 5.2K vs not measurable since none of the patients analysed with small NGS panels were eligible).

Conclusions and relevance
MTB discussion of genomic data obtained with NGS comprehensive panels significantly increases patient eligibility to targeted therapies and optimise the cost to find a patient eligible to personalised treatments, mainly for CCA, PC and GEC patients.

Objective
The use of e-health interventions has grown in demand due to their accessibility, low implementation costs and their potential to improve the health and well-being of people across a large geographical area. Despite these potential benefits, little is known about the cost-effectiveness of self-guided e-health interventions. The aim of the study was to compare the cost and consequences of ‘iSupport’, an e-health intervention to reduce mental health issues in dementia carers.

Design
A cost-consequence analysis (CCA) of a multi-centre, single-blind randomised controlled trial of iSupport. The CCA was conducted from a public sector (National Health Service, social care and local authority) perspective plus a wider societal perspective. Delivery costs of iSupport were collected using a bottom-up micro-costing approach.

Setting
352 participants were recruited from three centres in England, Wales and Scotland.

Participants
Participants eligible for inclusion were adults over the age of 18 years who self-identified as an unpaid carer with at least 6 months of experience caring for an individual with a diagnosis of dementia. Between 12 November 2021 and 31 March 2023, 2332 carers were invited to take part in the study. 352 participants were randomised: 175 randomised to the iSupport intervention group and 177 to the usual care control group. The mean age of participants in the intervention and control groups was 63 and 62, respectively.

Main outcome measures
The CCA presented the disaggregated costs and health-related quality of life measured using the EuroQol five-dimension.

Results
There was no significant difference in generic health-related quality of life measured using the EQ-5D-5L (p=0.67). Both groups reported higher mean costs between baseline and 6 months, but the change in costs was significantly lower in the intervention group. Between baseline and 6 months, the mean change in total resource use costs from the public sector perspective was significantly different between groups (p=0.003, r=–0.161) reporting a mean change per participant of £146 (95% CI: –33 to 342) between the intervention and control groups. From the wider societal perspective, there was no significant difference (p=0.23) in the mean change in total resource use and informal care costs between the two groups from baseline to 6 months.

Conclusion
Use of iSupport was associated with reduced health and social care resource use costs for carers compared with care-as-usual. Self-guided e-health interventions for dementia carers may have the potential to reduce health and social care resource use and wider societal costs, but evidence relating to their effectiveness and cost-effectiveness is lacking.

Trial registration number
ISRCTN17420703.

Objective
To assess the magnitude of clinical inertia and its associated factors among adult patients with asthma on chronic follow-up at Jimma Medical Center, Ethiopia, from December 2021 to May 2022.

Design and setting
A hospital-based prospective observational study was conducted in Jimma Medical Center from 1 December 2021 to 30 May 2022.

Participants
135 patients with asthma who fulfilled the inclusion criteria were enrolled in the study consecutively and followed for 3 months.

Results
Of 148 patients, 135 patients’ data were analysed. The mean (SD) age of the patients was 52.03 (±15.75) years. More than half (54.1%) of the study participants were men. Most of the study participants (68.9%) at the first and (70.4%) at the second visit, which is 3 months after the first visit, had clinical inertia, respectively. Comorbidity (adjusted OR (AOR) 3.35, 95% CI (1.15, 9.81), p

Objectives
To investigate the prevalence and potential determinants of cost-related non-adherence (CRNA) in US adults with heart failure (HF).

Design
A serial cross-sectional analysis using nationally representative data from 2012 to 2021 of the US Medical Expenditure Panel Survey.

Setting
Population-based.

Participants
Adult participants with HF diagnosis.

Outcome measures
Self-report of never getting or delaying getting prescription medicine because of costs.

Results
We included 1753 patients with HF (mean age 69.36 [95% CI, 68.23 to 70.48]) years, 47.85% men and 17.09% non-Hispanic Black. The overall weighted prevalence of CRNA was 7.94% (6.40–9.81), increasing from 3.09% (1.29–7.24) in 2012 to 13.69% (8.99–20.32) in 2018 and decreasing to 8.71% (3.82–18.67) in 2021. The prevalence of CRNA was higher among patients

Introduction
Depressive disorders in adolescents are highly prevalent and debilitating and are a risk factor for self-harm and death by suicide. In the context of recovery from the COVID-19 pandemic, strained healthcare resources are compounded by an increased demand for treatment services for adolescents with depression. The objective of this study protocol is to delineate the proposed economic evaluation of an integrated care pathway for depression in adolescents within the Care for Adolescents who Received Information ‘Bout Outcomes, 2nd iteration (CARIBOU-2) non-randomised, cluster-controlled trial.

Methods and analysis
Two economic evaluations of the CARIBOU-2 trial (n=300) will be conducted—a cost-effectiveness analysis and a cost-utility analysis. In the cost-effectiveness analysis, we will examine the primary clinical outcome of the trial, change in the Mood and Feelings Questionnaire total score. In the cost-utility analysis, the clinical outcome will be quality-adjusted life-years, a generic measure of health burden. Data on the resources and respective costs required to deliver the intervention will be collected by the research team. Data on resource use post-intervention will be obtained from a mix of administrative data holdings and self-report; relevant unit costs will be obtained from existing data sources. The outcome of both economic evaluations will be the incremental cost-effectiveness ratio. Relevant sensitivity analyses will be undertaken, and cost-effectiveness acceptability curves will be produced to characterise any sources of uncertainty in the analysis. Equity considerations will also be examined, where relevant.

Ethics and dissemination
Ethical approval for the larger CARIBOU-2 trial, including the economic evaluation, has been obtained by the Centre for Addiction and Mental Health as well as site-level ethics boards (019/2021; Centre for Addiction and Mental Health). All participants will provide informed consent for their data to be analysed and reported. The results of the main trial and the economic evaluation will be submitted for publication in a peer-reviewed journal and shared with relevant policy makers across Canada.

Trial registration number
NCT05142683.

Objective
To evaluate the association between body composition from early pregnancy to 42 days postpartum and postpartum weight retention (PPWR).

Design
This retrospective cohort study was conducted at Chengdu Shuangliu Maternal and Child Health Care Hospital from June 2020 to December 2021.

Setting
The study was conducted in Sichuan Province, southwestern China.

Participants
A total of 673 pregnant women at 6–13 weeks of gestation were included.

Outcome measures
Demographic and health information of participants was collected from the electronic medical record system using a self-designed questionnaire. Body fat percentage (PBF), fat mass (FM), fat-free mass (FFM), lean mass (LM) and protein were measured using bioelectrical impedance analysis. Logistic regression and restricted cubic spline (RCS) analyses were performed to examine the association between body composition and PPWR.

Results
During early pregnancy, compared with the bottom quartile group, women in the top quartile group of PBF and FM levels had a 51% (95% CI 0.24 to 0.99) and 64% (95% CI 0.17 to 0.76) lower risk of PPWR, respectively. For each SD increase in PBF and FM levels, the risk of PPWR decreased by 29% (95% CI 0.55 to 0.91) and 35% (95% CI 0.50 to 0.85), respectively. In contrast, at 42 days postpartum, for each SD increase in PBF, FM, FFM and LM levels, the PPWR risk elevated by 251% (95% CI 2.70 to 4.62), 315% (95% CI 3.15 to 5.57), 56% (95% CI 1.30 to 1.89), and 71% (95% CI 1.42 to 2.09). RCS analysis revealed that PBF and FM levels during early pregnancy were negatively correlated with the risk of PPWR (p-overall

Objectives
To estimate the prevalence of urinary incontinence (UI) and its subtypes among nulliparous Chinese women with associated risk factors. The prevalence of UI among those living in urban or rural communities was also analysed with potential risk factors.

Design
This is a secondary analysis of epidemiological survey data on UI in Chinese women. The original study was designed as a nationwide cross-sectional study involving 56 460 adult women conducted from October 2019 to December 2021.

Setting
Seven geographic regions of China.

Participants
Nulliparous women who were aged ≥20 years old and were permanent residents were included in this secondary analysis. Participants who had severe mental or physical disorders or were pregnant were excluded. Data on demographic characteristics, health status and medical history were collected.

Primary and secondary outcome measures
The primary outcome was the prevalence of UI, whereas secondary outcome measures were adjusted odds ratios (aOR) for risk factor analysis.

Results
A total of 6244 nulliparous women were included in the analysis. The prevalence of UI was 1.9% for nulliparous Chinese women, with stress, urgency and mixed UI being prevalent at 0.9%, 0.3% and 0.7%, respectively. The prevalence of UI was 2.1% and 1.6% for urban and rural subgroups. Abnormal body mass index was significantly associated with UI in the nulliparous group (underweight, aOR: 1.88, 95% CI: 1.03 to 3.45, p=0.041; overweight, aOR: 2.26, 95% CI: 1.37 to 3.73, p=0.001; and obesity, aOR: 3.64, 95% CI: 1.86 to 7.15, p