Search Results for: Screening della retinopatia diabetica

Background
There are different modes and ways to assess patient-reported outcomes (PROs) in clinical trials. However, there is little systematic information on how often different modes of assessment (MOA) are used in cancer clinical trials and how exactly assessments are conducted. The goal of this scoping review is to gain an understanding of the MOA and data management of PROs in cancer randomised controlled trials (RCTs) and the reporting quality thereof.

Methods and analysis
This scoping review protocol follows the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. Relevant trials will be identified via their indexed publications. We will search PubMed for RCTs conducted in cancer populations that evaluate a biomedical treatment with a PRO endpoint. Trials with publications published between January 2019 and November 2023 will be included. Two independent reviewers will review the references for both the abstract and full-text screening. We will extract data from the publications from a trial and the trial protocol if a protocol can be traced. Data will be summarised at the trial level. We will focus on a descriptive analysis of the MOA of PROs and on the relative frequencies of the different MOA. We will also evaluate the quality of reporting for the relevant SPIRIT and CONSORT guidelines that refer to the assessment of PROs in trials. Due to the scoping nature of our review, we will not perform a dedicated quality assessment of all trials.

Ethics and dissemination
The proposed review is based on secondary, published data. Hence, no ethics review is necessary. The review is part of an ongoing project on the use of electronic data capture methods in cancer clinical trials. The findings from the review will support the project and contribute to synthesising guidance to ultimately improve the (electronic) measurement of patient-reported outcome measures in clinical trials.

Introduction
Care aides are health workers who deliver hands-on care to patients across the healthcare continuum. The use of technology in healthcare delivery is increasing, and evidence regarding how care aides’ attitudes may either facilitate or hinder the adoption of healthcare technologies is lacking.
The aim of the proposed scoping review is to examine available evidence regarding care aides’ attitudes towards the adoption of innovation and factors that may influence the sustainable use of technology in healthcare delivery. Published studies, grey literature and review articles that identify a method for the review, conference abstracts and website publications regarding the attitude, uptake and sustainable use of technology in care delivery by care aides will be included. For abstracts that have resulted in publications, the full publications will be included. The search for evidence commenced in June 2023 and will end in March 2024.

Methods and analysis
The Joanna Briggs Institute (JBI) method will be used to conduct the review. The CINAHL, Cochrane Library, EMBASE, MEDLINE, ProQuest, PubMed, SCOPUS, PROSPERO, Web of Science and JBI Evidence Synthesis databases will be searched using keywords for publications within the last 20 years to examine trends in health technology and attitudes of care aides towards innovation over the last two decades. A search of grey literature and websites will be conducted. The reference list of the retrieved articles will be used to identify additional literature. The search results will be exported into a literature management tool for screening and analysis. Article screening will be performed by two authors and if a third is needed to resolve any differences. Data analysis will be guided by two theoretical frameworks.

Ethics and dissemination
No ethics approval is required. The findings will be disseminated in a peer-reviewed journal and presented in conferences.

Registration details
https://doi.org/10.17605/OSF.IO/CZQUP

Objective
Healthy lifestyle centres (HLCs), a state service that screens for major non-communicable disease (NCD) risk factors and promotes lifestyle modifications in Sri Lanka, report underutilisation. The study aimed to assess the effectiveness of a participatory intervention to empower communities in improving HLC utilisation.

Design
A quasi-experimental study based on the principles of community-based participatory research

Setting
Six rural communities each as the intervention (IG) (Gampaha district) and comparison (CG) groups (Kalutara district) from the capital province of Sri Lanka.

Participants
Study population was healthy individuals aged 35–65 years, the target group of HLCs in Sri Lanka. A random sample of 498 individuals was selected from each group for evaluation.

Interventions
Community support groups (CSGs) were established and empowered using health promotion approach from August 2019 to February 2020. Group discussions and participatory mapping were conducted to identify determinants of underutilisation of HLCs, design activities to address prioritised determinants and develop indicators to monitor the progress of CSGs.

Primary and secondary outcome measures
The primary outcome was improvement of HLC utilisation and the secondary outcome was initiation of lifestyle modifications.

Results
Significant improvements were seen in the IG, compared with the CG in the seven determinants that contribute to HLC utilisation. The largest differences were seen in reducing negative perceptions of susceptibility for NCDs (pre=64.7%; post=33.3%; p

Objectives
To identify the barriers and facilitators to the successful implementation of imaging-based diagnostic artificial intelligence (AI)-assisted decision-making software in China, using the updated Consolidated Framework for Implementation Research (CFIR) as a theoretical basis to develop strategies that promote effective implementation.

Design
This qualitative study involved semistructured interviews with key stakeholders from both clinical settings and industry. Interview guide development, coding, analysis and reporting of findings were thoroughly informed by the updated CFIR.

Setting
Four healthcare institutions in Beijing and Shanghai and two vendors of AI-assisted decision-making software for lung nodules detection and diabetic retinopathy screening were selected based on purposive sampling.

Participants
A total of 23 healthcare practitioners, 6 hospital informatics specialists, 4 hospital administrators and 7 vendors of the selected AI-assisted decision-making software were included in the study.

Results
Within the 5 CFIR domains, 10 constructs were identified as barriers, 8 as facilitators and 3 as both barriers and facilitators. Major barriers included unsatisfactory clinical performance (Innovation); lack of collaborative network between primary and tertiary hospitals, lack of information security measures and certification (outer setting); suboptimal data quality, misalignment between software functions and goals of healthcare institutions (inner setting); unmet clinical needs (individuals). Key facilitators were strong empirical evidence of effectiveness, improved clinical efficiency (innovation); national guidelines related to AI, deployment of AI software in peer hospitals (outer setting); integration of AI software into existing hospital systems (inner setting) and involvement of clinicians (implementation process).

Conclusions
The study findings contributed to the ongoing exploration of AI integration in healthcare from the perspective of China, emphasising the need for a comprehensive approach considering both innovation-specific factors and the broader organisational and contextual dynamics. As China and other developing countries continue to advance in adopting AI technologies, the derived insights could further inform healthcare practitioners, industry stakeholders and policy-makers, guiding policies and practices that promote the successful implementation of imaging-based diagnostic AI-assisted decision-making software in healthcare for optimal patient care.

Introduction
Undetected high-risk conditions in pregnancy are a leading cause of perinatal mortality in low-income and middle-income countries. A key contributor to adverse perinatal outcomes in these settings is limited access to high-quality screening and timely referral to care. Recently, a low-cost one-dimensional Doppler ultrasound (1-D DUS) device was developed that front-line workers in rural Guatemala used to collect quality maternal and fetal data. Further, we demonstrated with retrospective preliminary data that 1-D DUS signal could be processed using artificial intelligence and deep-learning algorithms to accurately estimate fetal gestational age, intrauterine growth and maternal blood pressure. This protocol describes a prospective observational pregnancy cohort study designed to prospectively evaluate these preliminary findings.

Methods and analysis
This is a prospective observational cohort study conducted in rural Guatemala. In this study, we will follow pregnant women (N =700) recruited prior to 18 6/7 weeks gestation until their delivery and early postpartum period. During pregnancy, trained nurses will collect data on prenatal risk factors and obstetrical care. Every 4 weeks, the research team will collect maternal weight, blood pressure and 1-D DUS recordings of fetal heart tones. Additionally, we will conduct three serial obstetric ultrasounds to evaluate for fetal growth restriction (FGR), and one postpartum visit to record maternal blood pressure and neonatal weight and length. We will compare the test characteristics (receiver operator curves) of 1-D DUS algorithms developed by deep-learning methods to two-dimensional fetal ultrasound survey and published clinical pre-eclampsia risk prediction algorithms for predicting FGR and pre-eclampsia, respectively.

Ethics and dissemination
Results of this study will be disseminated at scientific conferences and through peer-reviewed articles. Deidentified data sets will be made available through public repositories. The study has been approved by the institutional ethics committees of Maya Health Alliance and Emory University.

Introduction
When mental disorders go undetected until later stages, they can result in poorer health outcomes for patients. Primary healthcare (PHC) stands as a strategic setting for the early identification and management of these mental disorders, given its role as the primary care environment for health service users. This scoping review has the objective of mapping and assessing screening instruments validated for mental disorders that are applicable in PHC, particularly regarding their measurement properties.

Methods and analysis
This scoping review will include studies that have developed and validated screening instruments for mental disorders in the PHC context, irrespective of the age group. Searches will be conducted in MEDLINE, EMBASE, LILACS, CINAHL and PsycInfo without imposing restrictions on publication status, publication year or language. Additionally, we will scrutinise the references cited in the selected studies. Our inclusion criteria encompass studies examining any measurement property recommended by the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) taxonomy. The selection process, data extraction and quality assessment of studies will be performed independently by pairs of reviewers. To evaluate the risk of bias within the selected studies, we will employ the COSMIN Risk of Bias 2 tools. The collected data will undergo analysis using descriptive statistics and will be presented in an evidence gap map format for each specific mental disorder.

Ethics and dissemination
The findings from this review will be discussed through deliberative dialogue with stakeholders and disseminated through peer-reviewed publications and conference presentations. The project was approved by the Ethics Committee for Research at the University of Sorocaba (number: 66993323.9.0000.5500).

Trial registration number
Open Science Framework – 10.17605/OSF.IO/Z6T5M.

Objectives
To provide an overview of the outcome measures currently used after sports-related concussion (SRC) in adolescents, categorising by the constructs they assess, follow-up duration and their feasibility of use.

Design
Scoping review.

Data sources
We searched three electronic databases (MEDLINE, EMBASE and CINAHL). We also undertook citation tracking of the included articles and searched for ongoing or unpublished trials using ClinicalTrials.gov and Theses Global.

Eligibility criteria
Studies tracking concussion recovery in adolescent athletes.

Results
15 782 records were identified. After initial title and abstract screening, we retrieved 87 studies for full-text screening, with 75 studies fulfilling the eligibility criteria and included in the review, comprising 13 107 participants (9480 male, 3615 female and 12 unreported), ranging in age from 5 to 19 years. 46 different outcome measures were used, with Post-Concussion Symptom Scale (n=42) and Immediate Post-Concussion Assessment and Cognitive Testing (n=21) the most common. Most outcome measures quantified aspects of sensorimotor function including balance, oculomotor function and cognition. Follow-up duration ranged from 7 days to 1 year. 60% of studies ceased follow-up assessments within 6 weeks post-SRC.

Conclusions
Adolescent SRC literature uses a wide range of outcome measures. Most research quantifies cognitive/fatigue domains in the acute/subacute stages post-SRC, using male participants. Other key domains such as anxiety/mood, migraine and key modifiers (cervical and sleep disturbance) are less well represented in the literature. Many of the outcome measures used in current research are associated with high cost and require highly qualified examiners, creating barriers to their implementation in some adolescent sporting environments.

Study registration
https://doi.org/10.17605/OSF.IO/N937E

Introduction
Promising evidence is emerging for the procognitive, anti-inflammatory and neuroprotective properties of dietary flavonoids, particularly anthocyanins that provide red, purple and blue plant pigments.

Methods and analysis
The ‘Food for Thought’ study is a multicentre, 6-month randomised, parallel 3-arm clinical trial. Its primary aim is to investigate whether anthocyanin consumption, either through diet or supplementation, can prevent memory loss progression and improve inflammatory and cardiovascular health in older adults at risk for dementia. Eligible participants will include those aged 60–85 years with a diagnosis of amnestic mild cognitive impairment or with a self-referral of memory concerns and scoring ≤13 on the Memory Index Score within the Telephone Montreal Cognitive Assessment screening test. Participants will be randomised to one of three arms: High anthocyanin (‘purple foods’) diet (aiming for a target of 250 mg anthocyanins/day); freeze-dried product derived from blackcurrants (250 mg anthocyanins/day); or control (coloured maltose powder). The primary outcome is auditory anterograde memory functioning assessed by the Buschke and Grober Free and Cued Selective Reminding Test-Immediate Recall. Secondary outcomes are additional cognitive functions including processing speed, working memory, aspects of executive functioning (attentional shifting and word generativity) and premorbid estimate as well as subjective memory problems and self-reported depression symptoms. Additional secondary outcomes are blood pressure, inflammatory biomarkers, brain-derived neurotrophic factor, fatty acid profile, apolipoprotein E and polyphenol metabolites, gut microbiota composition and function and vascular and microvascular endothelial function tests. Repeated measures analysis of variance and/or mixed linear modelling will evaluate changes over time, with the inclusion of covariates.

Ethics and dissemination
Ethics approval has been obtained from the Greater Western Human Research Ethics Committee (2021/ETH12083). A Consumer Advisory Group was established to guide and review the protocol and dissemination strategy. The results of this trial are intended to be published in a peer-reviewed journal.

Trial sponsor
National Health and Medical Research Centre Dementia Collaborative Research Centre.
Start date of clinical trial: 02 September 2022.
Expected end date: 11 October 2024.

Trial registration number
ACTRN12622000065796.

When this scenario occurs during screening, incidence of upper endoscopy–detectable cancer is very low.

In provincia di Ancona già eseguiti più di 15mila prelievi

To the Editor Secondary analysis of the CAP study reported 15-year mortality rates among men who received an invitation for a PSA screening test followed by further diagnostic evaluation if the PSA was 3.0 ng/mL or greater compared with a control group who did not undergo PSA screening. Although there was increased detection of low-grade and localized prostate cancer among men in the PSA screening and intervention group, there was minimal absolute reduction in prostate cancer mortality (0.09%) and no reduction in all-cause mortality compared with the control group. This begs the question: Can prostate biopsies trigger the spread of prostate cancer in some men, thereby diminishing any potential benefit from early detection and treatment?

In Reply We thank Dr D’Amico for his Letter, in which he states that nonattendance and contamination may have led the CAP study to underestimate the benefit of an invitation to a single PSA screening test for reducing prostate cancer mortality over a median 15-year follow-up (intention-to-treat estimate rate ratio, 0.92 [95% CI, 0.85-0.99]; P = .03). This finding corresponded to a reduction of 1 fewer prostate cancer death per 1000 men invited to screening compared with the control group over a median follow-up of 15 years (8 prostate cancer deaths per 1000 men in the control group vs 7 prostate cancer deaths per 1000 men invited to PSA screening). D’Amico states that the difference in PSA testing between the 2 randomized groups was approximately 30%, whereas, ideally, there should be a 100% difference between groups.

To the Editor In a secondary analysis of the Cluster Randomized Trial of PSA Testing for Prostate Cancer (CAP), the secondary end point of prostate cancer–specific mortality was significantly reduced, with a rate ratio of 0.92 (95% CI, 0.85-0.99; P = .03) after a median follow-up of 15 years. I agree with the authors that this result is modest, yet it is important to note that both nonattendance (ie, individuals randomized to the intervention group who did not have a prostate-specific antigen [PSA] test) and contamination (ie, individuals randomized to the standard group who had at least 1 PSA test) can affect the magnitude of the rate ratio for prostate cancer–specific mortality. Specifically, as the authors noted in their CAP article from 2018, the contamination rate was estimated at 10% to 15%, meaning at least 10% of participants in the standard group received at least 1 PSA test. In the current article, the authors noted that the nonattendance rate in the intervention group was 60% and an additional 6% of participants did not have a valid PSA test result. Therefore, in the best-case scenario, the difference in the PSA testing between the 2 randomized groups would be 30% (40% minus 10%). Specifically, 40% in the intervention group was derived from the 60% nonattendance rate and 10% in the standard group was due to contamination. Ideally, to assess the value of a single PSA test on prostate cancer–specific mortality, the difference in PSA testing between the 2 randomized groups should be 100%. As a result, the effect of a single PSA screen on the end point of prostate cancer–specific mortality is likely to be greater than the reported 8% reduction, as reflected in the rate ratio of 0.92. Therefore, it is important to recognize that the results of the CAP study may have underestimated the true effect of a single PSA screen on prostate cancer–specific mortality.

Objective
During the last decade, the management of gastric intestinal metaplasia (GIM) has been addressed by several distinct international evidence-based guidelines. In this review, we aimed to synthesise these guidelines and provide clinicians with a global perspective of the current recommendations for managing patients with GIM, as well as highlight evidence gaps that need to be addressed with future research.

Design
We conducted a systematic review of the literature for guidelines and consensus statements published between January 2010 and February 2023 that address the diagnosis and management of GIM.

Results
From 426 manuscripts identified, 16 guidelines were assessed. There was consistency across guidelines regarding the purpose of endoscopic surveillance of GIM, which is to identify prevalent neoplastic lesions and stage gastric preneoplastic conditions. The guidelines also agreed that only patients with high-risk GIM phenotypes (eg, corpus-extended GIM, OLGIM stages III/IV, incomplete GIM subtype), persistent refractory Helicobacter pylori infection or first-degree family history of gastric cancer should undergo regular-interval endoscopic surveillance. In contrast, low-risk phenotypes, which comprise most patients with GIM, do not require surveillance. Not all guidelines are aligned on histological staging systems. If surveillance is indicated, most guidelines recommend a 3-year interval, but there is some variability. All guidelines recommend H. pylori eradication as the only non-endoscopic intervention for gastric cancer prevention, while some offer additional recommendations regarding lifestyle modifications. While most guidelines allude to the importance of high-quality endoscopy for endoscopic surveillance, few detail important metrics apart from stating that a systematic gastric biopsy protocol should be followed. Notably, most guidelines comment on the role of endoscopy for gastric cancer screening and detection of gastric precancerous conditions, but with high heterogeneity, limited guidance regarding implementation, and lack of robust evidence.

Conclusion
Despite heterogeneous populations and practices, international guidelines are generally aligned on the importance of GIM as a precancerous condition and the need for a risk-stratified approach to endoscopic surveillance, as well as H. pylori eradication when present. There is room for harmonisation of guidelines regarding (1) which populations merit index endoscopic screening for gastric cancer and GIM detection/staging; (2) objective metrics for high-quality endoscopy; (3) consensus on the need for histological staging and (4) non-endoscopic interventions for gastric cancer prevention apart from H. pylori eradication alone. Robust studies, ideally in the form of randomised trials, are needed to bridge the ample evidence gaps that exist.

Introduction
Patient safety culture is a critical factor in improving the quality of home healthcare and preventing adverse events in patients receiving care in home health centres. However, the concept of patient safety culture in home healthcare centres is not clearly defined, and its dimensions and characteristics are still largely unknown. The aim of this scoping review is to provide a comprehensive overview of research on patient safety culture in home healthcare centres, identify related definitions and characteristics, and focus on key factors to fill the existing knowledge gaps.

Methods and analysis
This review will follow Arksey and O’Malley’s methodological framework, updated by the Joanna Briggs Institute (JBI), which comprises five stages: identifying the research question, identifying relevant studies, selecting the studies, charting the data, and collating, summarising and reporting the results. The inclusion criteria will be based on the Population, Concept and Context framework. A comprehensive search of PubMed, Embase, Scopus, ProQuest, Web of Science, Cochrane and grey literature sources, with no date restrictions, was conducted with the assistance of a qualified research librarian to include all relevant published study designs and ensure a thorough understanding of the topic. The search will be continuously updated until the study is completed. In addition, we will review the reference lists of the final included studies and their citations to find further relevant studies. Studies that are duplicates and those not written in Persian or English will be excluded. The selection of studies based on the eligibility criteria will carried out by two independent reviewers who will perform a title/abstract screening followed by a full-text screening. Data extraction will be conducted using a standardised form from the JBI. Descriptive and content analyses will be conducted to identify key concepts in the literature reviewed.

Ethics and dissemination
No ethical review is required for this study. Results will be submitted for publication in a peer-reviewed journal and presented at conferences.

Introduction
Women engaging in sex work (WESW) have 21 times the risk of HIV acquisition compared with the general population. However, accessing HIV pre-exposure prophylaxis (PrEP) remains challenging, and PrEP initiation and persistence are low due to stigma and related psychosocial factors. The WiSSPr (Women in Sex work, Stigma and PrEP) study aims to (1) estimate the effect of multiple stigmas on PrEP initiation and persistence and (2) qualitatively explore the enablers and barriers to PrEP use for WESW in Lusaka, Zambia.

Methods and analysis
WiSSPr is a prospective observational cohort study grounded in community-based participatory research principles with a community advisory board (CAB) of key population (KP) civil society organi sations (KP-CSOs) and the Ministry of Health (MoH). We will administer a one-time psychosocial survey vetted by the CAB and follow 300 WESW in the electronic medical record for three months to measure PrEP initiation (#/% ever taking PrEP) and persistence (immediate discontinuation and a medication possession ratio). We will conduct in-depth interviews with a purposive sample of 18 women, including 12 WESW and 6 peer navigators who support routine HIV screening and PrEP delivery, in two community hubs serving KPs since October 2021. We seek to value KP communities as equal contributors to the knowledge production process by actively engaging KP-CSOs throughout the research process. Expected outcomes include quantitative measures of PrEP initiation and persistence among WESW, and qualitative insights into the enablers and barriers to PrEP use informed by participants’ lived experiences.

Ethics and dissemination
WiSSPr was approved by the Institutional Review Boards of the University of Zambia (#3650-2023) and University of North Carolina (#22-3147). Participants must give written informed consent. Findings will be disseminated to the CAB, who will determine how to relay them to the community and stakeholders.