Search Results for: Quotidianosanita.it

Introduction
Medical comorbidity at diagnosis is associated with treatment outcome in cancer. The aim of this project is to synthesise the evidence on the association between medical comorbidities and paediatric acute lymphoblastic leukaemia and lymphoblastic lymphoma outcomes.

Methods and analysis
A systematic review of the literature will be conducted by developing a search strategy that will combine medical subject headings and natural language key words related to acute lymphoblastic leukaemia or lymphoma, medical comorbidities and treatment-related outcomes. We will search MEDLINE and EMBASE to identify studies in human subjects and written in English from the inception of each database to 30 September 2022. Two authors will independently screen the titles and abstracts of retrieved studies based on the inclusion and exclusion criteria to identify potentially eligible studies. Full-text articles of eligible studies and final included articles will be retrieved and reviewed in a similar manner by two independent reviewers. Data extraction from included articles will be conducted independently by two authors using a standardised data extraction form. Risk of bias in the included studies will be assessed using existing relevant tools. A narrative and tabular summary of the data, including outcomes, will be provided if the data do not warrant a meta-analysis. If a meta-analysis is feasible, we will pool all the effect estimates. Heterogeneity among study effect sizes will be tested with Cochran’s Q test and quantified by the I2 statistic.

Ethics and dissemination
This study will not include the collection of original data, but it will be a summary of aggregate existing data. Thus, ethics approval is not applicable. The findings of the study will be disseminated through peer-reviewed publications.

PROSPERO registration number
CRD42022366669.

Introduction
The integration of dental services within the broader healthcare landscape is crucial for achieving integrated healthcare delivery. However, we lack a clear representation of the full spectrum of possible dental service integration, which is necessary for policymakers, healthcare system organisers, researchers, professionals and patients themselves to optimise organisations. Our present research aims to establish the foundation for a taxonomy of dental services that is fully integrated into the health domain, while minimising historical, cultural or epistemological biases.

Methods and analysis
This protocol outlines a scoping review that will adhere to the framework of the Joanna Briggs Institute and the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Extension for Scoping Reviews guidelines. It has also been registered on the Open Science Framework. The research team, including a patient representative, advocate and transdisciplinary researcher, who has been involved from the inception, describes a two-phase dynamic screening process. An initial search will be conducted in the PubMed database using a Boolean search strategy based on theoretical frameworks that view health through a biopsychosocial continuum. New taxa will be progressively identified, and in the second phase, we will develop a new search strategy based on the results obtained and will explore deeper into certain categories or subcategories of taxa. Iterative strategies may also involve using new databases and even grey literature. This process will be repeated until taxon saturation is achieved and will be updated prior to submission to capture the latest literature, ultimately resulting in a comprehensive taxonomy, at the scale of individual healthcare pathways (micro- and meso-levels of organisation).

Ethics and dissemination
This scoping review will analyse published secondary data and does not require ethical review. The findings will be disseminated through publication in scientific journals, presentation at conferences and sharing through professional networks.

Objective
To compare recovery after laparoscopic hysterectomy (LH) and abdominal hysterectomy (AH).

Design
A parallel, open, non-inferiority, multicentre, randomised controlled, expertise-based surgery trial.

Setting
10 NHS (National Health Service) hospitals within the UK.

Participants
Women undergoing hysterectomy for a benign gynaecological condition.

Interventions
Consenting women of 18–55 years were randomised to LH or AH using a secure internet facility by a surgeon with self-declared expertise. Major complications were recorded by clinicians, and recovery was assessed by regular text messaging and postal questionnaires.

Primary and secondary outcome measures
Major surgical complications (Clavien-Dindo≥level 3) up to six completed weeks postsurgery, time to resumption of normal activities measured by the Patient-Reported Outcomes Measurement Information System Physical Function tool and quality of recovery at 24 hours (Quality of Recovery 15 score; 0–150).

Results
75 women were randomised before early curtailment of the trial; 32/39 (82%) and 30/36 (83%) women underwent LH and AH, respectively. Major complications occurred in 2/32 (6%) LH versus 4/30 (13%) AH groups. No difference in time to resumption of usual activities was found (median [IQR, n] 7.5 weeks (3.6–8.2, 25) LH vs 7.5 weeks (5.5–10.6, 26) AH groups or quality of recovery (mean [SD, n] 81.1 (13.4, 27) vs 72.3 (17.6, 22), respectively; adjusted mean difference 7.2, 95% CI –3.2 to 17.6).

Conclusions
No differences were found in complications or recovery between LH and AH. However, early cessation of the trial due to recruitment challenges limits clinical inferences. It is important that larger comparative trials are conducted now that LH, including robotics, is becoming adopted as standard practice.

Trial registration number
ISRCTN14566195, IRAS ID 287988.

Objectives
The double blind, multicentre, randomised, placebo-controlled GAG-therapy Efficacy Trial Solution for Bladder pain syndrome/Interstitial cystitis (GETSBI) study aims to evaluate the efficacy of intravesical glycosaminoglycans therapy with hyaluronic acid and chondroitin sulfate in symptomatic bladder pain syndrome/interstitial cystitis (BPS/IC) patients with Hunner lesions. This trial encompasses multiple methodologies, including a standard randomised controlled trial (RCT), a cross-over trial and an N-of-1 trial. An N-of-1 trial is a multiple crossover trial, usually randomised and often blinded, conducted in a single patient (1). The N-of-1 methodology is, however, only valid under the condition that there is no carry-over effect, meaning a carry-over of effect from an a-priori intervention period into the placebo period. Therefore, it is important to examine any potential carry-over effects to determine the validity of the study protocol concerning the N-of-1 trial part and thereby justifying recruitment.

Design
Interim analysis for potential carry-over effects.

Setting
Secondary care, 21 participants.

Participants
21 participants, participants concluded part one from the GETSBI study at time of this analysis (October 2023).

Outcome measure
The primary outcome of the study is the change from baseline in pain intensity, measured by visual analogue scale (VAS) pain. To assess for carry-over effects, the placebo responses on VAS pain were compared between groups with (n=10) and without (n=11) potential carry-over effects. The threshold for a clinically relevant carry-over effect was set at a difference on VAS pain >0.50 points. Data were analysed using descriptive statistics, T-tests, effect sizes and 95% CI. Statistical significance was set at α=0.05.

Results
The mean baseline VAS pain did not differ (p=0.12) between group A (n=10, VAS 7.52, SD=0.52) and group B (n=11, VAS 6.02, SD=2.47). The mean placebo responses on VAS pain for groups A and B were 0.97 (SD=1.85) and 1.47 (SD=1.81), respectively. The mean carry-over effect was 0.50 (SD=1.83), which was not statistically significant with a 95% CI of –1.17 to 2.17 and p=0.5369.

Conclusions
This interim analysis shows that an N-of-1 trial probably will be feasible for evaluating non-curative treatment efficacy in chronic disease using only half the patients as are required for a classic RCT. Future analysis will provide a direct comparison of outcomes between the RCT, crossover and the N-of-1 part for a complete evaluation.

Trial registration number
ClinicalTrials.gov, NCT05518864 (GETSBI study).

Objectives
Diabetic foot ulcer (DFU) is a major complication of poorly managed diabetes mellitus. Home care of individuals with chronic wounds is often supported by family members. The study aims to determine the burden of caregivers of DFU patients and the factors influencing this burden.

Design
A descriptive-correlational research.

Setting
The study sample consisted of caregivers of patients who applied to the Diabetic Foot Council between December 2022 and November 2023.

Participants
The study included 101 caregivers who were primarily responsible for the care of the DFU patient, had been caring for the patient for at least 2 months, provided unpaid care and agreed to participate in the study.

Outcome measures
Data were collected using the Descriptive Characteristics Form and Zarit Caregiver Burden Scale.

Results
The mean age of the caregivers was 45.34±12.62, and the mean age of the patients was 59.57±9.18. The care burden of caregivers was 46.47±11.39. The highest levels of care burden were observed in the economic and dependency subscales. When the relationship between the independent variables of the model and the dependent variable was examined, it was found that providing support to move the patient [β=0.97; p=0.001] and the need for training in patient care [β=0.51; p=0.012] were independent factors that increased the burden of the caregiver, while the patient’s ability to follow his/her own medication [β=–0.46; p=0.039] was the independent factor that decreased the burden of the caregiver.

Conclusion
Based on these findings, further research is required to assess the effectiveness of professional healthcare services, self-care interventions and support strategies aimed at alleviating caregiver burden and enhancing care quality.

Longitudinal analysis across three large cohorts found that it is rare for patients with CHIP to develop MN without first developing cytopenia. The risk for MN among patients with CHIP resides almost entirely among those with cytopenia. These findings suggest that cytopenia is a critical step in progression from CHIP to MN, underscoring its utility as an endpoint in cancer prevention trials for CHIP patients.

Objectives
The COVID-19 pandemic induced significant changes in access policies to general practice (GP) in most countries. This study aimed to compare and discuss changes in the diagnostic patterns and GP procedures before and during the pandemic.

Design and setting
A register study including data from 11 Danish GP clinics.

Participants
Enlisted patients from GP followed 1 year before (February 2019 to January 2020; n=48 650) and 1 year during (April 2020 to March 2021; n=47 207) the COVID-19 pandemic.

Outcome measures
Diagnostic patterns, consultation type (face-to-face, email and phone), contact persons (GP or GP staff) and patient characteristics.

Results
The average number of contacts with GP increased from 6.3 contacts per year per patient before the pandemic to 8.3 annual contacts during the pandemic (p

Objectives
To understand and compare women’s antenatal and postnatal views on: (1) priorities for information provided about labour and delivery and (2) decision-making in labour and delivery.

Design
Qualitative interview study using repeat interviews at two time points: during pregnancy (≥13 weeks gestation); and after birth (≥6 weeks).

Setting
Large maternity hospital in the Southwest of England.

Participants
Pregnant women accessing antenatal care were purposively sampled and recruited antenatally by community midwives to ensure representation from different sociodemographic groups, with diverse experiences of low and high-risk care.

Data collection
Telephone interviews with a single researcher using a semistructured interview topic guide.

Data analysis
Interviews were audio recorded, transcribed verbatim, and qualitative thematic analysis was conducted using Braun and Clarke’s six-stage process.

Results
Twelve women participated (12 antenatal interviews; 10 follow-up postnatal interviews). Overall, women’s postnatal views were consistent with their antenatal views about what they wanted to know and the factors that influence decision-making. Three themes were generated. Theme 1 ‘Sources of information’ presents evidence of how women obtain and use information (sub-themes: ‘social influences’, ‘patient responsibility for information seeking’, ‘NHS vs non-NHS resources’). Theme 2 reports women’s views and experiences of ‘The influence of Healthcare Professionals in decision-making’ (sub-themes ‘patient and professional roles in decision-making’, ‘conflicting advice and preferences’, ‘taking authority in emergency decision-making’). The final theme, theme 3, ‘When, how, and what information women want’ shows women want time to process information (sub-themes ‘when: it’s definitely information and time’, ‘how: presentation of information’, ‘what: information required’). Cross-cutting all themes, we found an unmet need for information to be tailored to the individual.

Conclusions
Women understand decision-making during labour and birth is a dynamic process. Women can struggle with the volume, quality and timing of information available. In busy maternity settings, the challenge is to better equip women with the information they want, and health professionals with the information they need to provide for personalised care and shared decision-making. Antenatal interventions that warrant further research include decision aids, birth plans, and structured counselling using core information sets. Insights from both antenatal and postnatal perspectives will help inform their development.

Introduction
All those born with functioning ovaries will eventually experience menopause, and many will be symptomatic. However, significant gaps in the evidence base for menopause care remain. This National Institute for Health and Care Research James Lind Alliance Menopause Priority Setting Partnership (MAPS) will engage with clinicians and those with lived experience globally to determine the leading priorities for future menopause research.

Methods and analysis
MAPS will follow the established James Lind Alliance methodology which has already resulted in over 100 ‘top 10’ research priorities across health domains. It will be led by a steering group comprised of clinicians and lived experience members. Leveraging the networks of steering group members and partner organisations, the priority setting partnership will identify evidence uncertainties using an online survey. Evidence checking will be undertaken to determine which questions have already been answered. Prioritisation will be done in two stages, initially by online survey and then at a face-to-face workshop.

Ethics and dissemination
Ethical approval was not required. The final top 10 priorities for menopause, as ranked by stakeholders at the final consensus workshop, will be disseminated in the relevant peer-reviewed journals. A final report will be available on the MAPS and James Lind Alliance websites. The leading priorities will inform the future global research agenda for menopause.

Introduction
Globally, the demand for community palliative care, delivered within the home setting, is rising. Hospice support workers, also referred to as healthcare assistants, play a crucial role in providing this care, but evidence indicates they face challenges relating to inadequate training, isolation and emotional labour. This realist review aims to understand how peer support interventions can support healthcare assistants in delivering hospice care at home.

Methods and analysis
The realist review will follow a five-step process to explore the research question: (1) locating existing initial programme theories, (2) searching for evidence, (3) selecting and appraising evidence, (4) extracting and organising data and (5) synthesising evidence and drawing conclusions. Comprehensive searches of academic databases (CINAHL, MEDLINE, AMED, Scopus) and grey literature sources will be conducted between November and December 2024, with no restrictions on publication date applied. Search strategies will be iteratively refined, with evidence selected based on relevance and rigour. Data will be extracted and coded using a realist logic model of analysis. The review will develop an explanatory programme theory for peer-to-peer interventions which would identify what, how, for whom, why and in what circumstances peer-to-peer interventions may support delivery of hospice care at home. It will explore the contexts, mechanisms and outcomes of these interventions using context-mechanism-outcome configurations.

Ethics and dissemination
Ethical approval is not required as the review involves no primary data collection. This review aims to clarify research gaps, inform next stages of a wider study, policy and practice. Reporting of the findings will adhere to RAMESES publication standards for realist syntheses, ensuring transparency and rigour in reporting. Results will be disseminated through peer-reviewed publications, conference presentations and other strategies identified by the stakeholder group.

PROSPERO registration number
CRD42024606133.

Introduction
Homelessness across the early life course poses a grave and largely preventable challenge. Those who experience homelessness early are at increased risk of a range of health, education and social inequities that can extend across the life course. Better understanding of the modifiable factors on the pathway to homelessness is needed to inform prevention at the earliest possible point in the life course and reduce the rate of child and adolescent homelessness at the population level. Here we address this gap in real-time knowledge by establishing a living systematic review of population studies of social determinants of homelessness from childhood to adolescence.

Methods and analysis
We will search MEDLINE, Embase, PubMed and PsycINFO for population-based prospective cohort studies reporting on social determinants of child and adolescent homelessness from 0 to 24 years. No study eligibility restrictions will be placed on the date, country of origin or language of publications. Study quality will be assessed using the Methodological Standards for Epidemiological Research scale. Associations between social determinants and homelessness will be reported using pooled relative risk ratios with 95% CI. If sufficient data are available, the influence of subgroup and methodological factors will be examined using meta-regression.

Ethics and dissemination
The study will synthesise published studies that have previously been granted ethics approval, meaning that it is exempt from ethics review or approval. Study findings will be disseminated through a peer-reviewed journal article, conference and seminar presentations. The authors will distribute a plain language summary through their academic and professional networks.

PROSPERO registration number
CRD42024577716.

Objectives
The aim of this study was to determine the feasibility of delivering personalised isometric exercise (IE) for people with stage 1 hypertension. Is it feasible to deliver an isometric wall squat intervention in the National Health Service and what sample size is required to conduct an appropriately powered effectiveness randomised controlled trial (RCT)?

Design
Randomised controlled open-label multicentre feasibility study of IE compared with standard care in unmedicated people with stage 1 hypertension.

Setting
Initially, the study aimed to recruit through primary care, but this process coincided with the advent of the COVID-19 pandemic. Therefore, we shifted focus to direct-to-public advertising and delivery in secondary care.

Participants
People with unmedicated stage 1 hypertension aged over 18 able to perform IE were included. Patients were excluded if average home systolic blood pressure (sBP)

Objectives
To compile and compare the Comprehensive Geriatric Assessment (CGA) models that exist worldwide and their applicability in primary healthcare (PHC).

Introduction
The world’s population is ageing rapidly, but health systems are slow to keep up with this trend, making it difficult to provide care for older adults. The broad concept of frailty has prompted a comprehensive and holistic approach to patients, where the assessment is related not only to functional, physical and cognitive abilities of the older adults, but also their social, environmental and economic context. In recent decades, the approach to frailty has taken the CGA as the gold standard. With this project, we intend to carry out a scoping review to identify and describe tools to help standardise and generalise CGA in PHC.

Inclusion criteria
Individuals aged 65 years or over; CGA in a PHC setting; the CGA methods reported must include at least three domains: physical, cognitive and social; Articles without language restrictions; Articles published in the last 30 years.

Methods
All studies that refer to CGA models and fulfil the inclusion criteria will be selected. A bibliographic search of articles will be carried out using the following electronic scientific publication databases: MEDLINE-PubMed, Embase, Cochrane Library and Web of Science. We will search for grey literature on sites such as ‘OpenGrey’ and thesis repositories such as RCAAP, EBSCO and EThOS, as well as on the WHO pages. The articles will be independently selected by two reviewers, and the data will be presented in narrative format, structured according to the objective, focus and question of the review.

Ethics and dissemination
Approved by the ethics committee of the regional health administration of the centre, registered as Project 11/2024 and approved on 8 May 2024. The findings of this study will be disseminated through peer-reviewed publications and national or international conference presentations. Updates of the review will be conducted, as necessary.

Trial registration number
Open Science (DOI 10.17605/OSF.IO/REH43).

Objective
This review aimed to map the concept of patient safety culture in emergency departments (EDs), describe the availability of evidence related to patient safety culture as assessed by healthcare workers, identify the key focus areas of existing studies and pinpoint gaps in the current literature.

Design
A scoping review followed a comprehensive methodological process that included five steps based on the framework developed by Arksey and O’Malley and updated by Peters et al.

Eligibility criteria
Studies encompassing original research and all pertinent published and grey literature within the last 15 years (2010–2024) that aligned with the population (healthcare workers), concept (patient safety culture) and context (emergency department) framework for this study were included.

Data sources
PubMed, CINAHL (EBSCOhost), WOS, Embase, MEDLINE (Ovid), and KISS databases were searched for original studies published between 2010 and 2024 that aligned with the topic of this study.

Data extraction and synthesis
Two researchers independently extracted data from 28 eligible articles using a predetermined data extraction tool. A third researcher reviewed the data to ensure accuracy.

Results
A total of 28 articles were included in the review. The findings indicated an increase in research on patient safety culture in emergency departments since 2021. However, no eligible studies have assessed it within North America. Teamwork within units was the most positively perceived dimension, whereas the reporting of patient safety incidents was the least positively perceived dimension.

Conclusions
Although research on patient safety culture in eergency departments has increased, the findings remain limited in their generalisability due to a lack of diverse methodologies. Qualitative studies are needed to deepen the understanding of patient safety culture in multifaceted contexts. This review contributes to the academic field by bringing us closer to developing tailored interventions that can foster a positive patient safety culture in emergency departments.

Protocol registration
The protocol for this scoping review was registered in the Open Science Framework (https://osf.io/9f7qc).

Circulation, Ahead of Print. BACKGROUND:Despite the significant global impact of the COVID-19 pandemic, limited studies have investigated the long-term cardiovascular sequelae of SARS-CoV-2 infection, particularly among Asian populations. This large-scale, population-based binational cohort study with long-term follow-up aimed to investigate the association between SARS-CoV-2 infection and the risk of cardiovascular events.METHODS:We used binational, large-scale, and population-based cohorts, including a Korean nationwide cohort (K-COV-N; discovery cohort; n=18 989 129) and a Japanese nationwide cohort (Japan Medical Data Center; validation cohort; n=12 218 680). Individuals aged 20 years or older were included from January 1, 2020, to December 31, 2022. We assessed the long-term risk of incident cardiovascular outcomes after SARS-CoV-2 infection. The primary outcome was the risk of cardiovascular diseases based onInternational Classification of Diseases, Tenth Revisioncode diagnosis. After propensity score–based overlap weighting, Cox proportional hazard models were used to estimate adjusted hazard ratios for cardiovascular outcomes. We assessed the time attenuation effect of cardiovascular outcomes after SARS-CoV-2 infection. Multiple subgroup analyses were conducted by 16 cardiovascular outcomes, COVID-19 severity, vaccination, and SARS-CoV-2 strain.RESULTS:In the overlap-weighted discovery cohort, 7 960 357 individuals were included (mean age, 48.52 years [SD, 9.33]; men, 4 283 878 [53.82%]). SARS-CoV-2 infection was associated with a long-term increased risk of overall cardiovascular outcomes (adjusted hazard ratio, 1.62 [95% CI, 1.60–1.64]), particularly ischemic heart disease (1.81 [95% CI, 1.77–1.84]), heart failure (1.79 [95% CI, 1.73–1.85]), cerebrovascular disorders (1.65 [95% CI, 1.60–1.69]), major adverse cardiovascular events (1.65 [95% CI, 1.60–1.70]), inflammatory heart diseases (1.53 [95% CI, 1.31–1.80]), dysrhythmia (1.44 [95% CI, 1.42–1.46]), and thrombotic disorders (1.42 [95% CI, 1.35–1.48]). The increased risk persisted up to 18 months, with the highest association observed for 1 to 6 months after infection. The risk of cardiovascular diseases was pronounced with COVID-19 severity; however, it decreased with the administration of complete vaccination and subsequent booster doses. A similar risk of cardiovascular outcomes existed across every SARS-CoV-2 era (pre-delta, delta, and omicron). Similar patterns were observed in the validation cohort. The absolute risk of cardiovascular disease events after SARS-CoV-2 infection remained remarkably low (2.12% versus 1.31% in the noninfected population), particularly stroke (0.24% versus 0.13%) and ischemic heart disease (0.73% versus 0.39%).CONCLUSIONS:This binational study observed associations between SARS-CoV-2 infection and cardiovascular events during extended follow-up across viral eras. Complete vaccination was linked to lower cardiovascular events. However, the absolute risk of cardiovascular disease events after SARS-CoV-2 infection remained remarkably low, particularly for stroke and ischemic heart disease. Although these findings suggest ongoing vigilance and preventive measures remain crucial, they should be interpreted within the context of these low absolute risks when considering long-term cardiovascular complications.

New England Journal of Medicine, Volume 392, Issue 21, Page 2151-2158, June 5, 2025.