Risultati per: Screening della retinopatia diabetica

Objective
To evaluate the performance of the fibrosis-4 (FIB-4) score as a screening tool to detect significant liver fibrosis (F2) compared with transient elastography (TE), among chronic transfusion-dependent beta-thalassaemia (TDT) patients in a resource-poor setting.

Design
A cross-sectional study.

Setting
Adolescent and Adult Thalassaemia Care Centre (University Medical Unit), Kiribathgoda, Sri Lanka.

Participants
45 TDT patients who had undergone more than 100 blood transfusions with elevated serum ferritin >2000 ng/mL were selected for the study. Patients who were serologically positive for hepatitis C antibodies were excluded.

Outcome measures
TE and FIB-4 scores were estimated at the time of recruitment in all participants. Predefined cut-off values for F2, extracted from previous TE and FIB-4 scores studies, were compared. A new cut-off value for the FIB-4 score was estimated using receiver operating characteristics curve analysis to improve the sensitivity for F2 prediction.

Results
Of the selected 45 TDT patients, 22 (49%) were males. FIB-4 score showed a significant linear correlation with TE (r=0.52;p

Introduction
Health policy leaders recommend screening and referral (S&R) for unmet social needs (eg, food) in clinical settings, and the American Heart Association recently concluded that the most significant opportunities for reducing cardiovascular disease (CVD) death and disability lie with addressing the social determinants of CVD outcomes. A limited but promising evidence base supports these recommendations, but more rigorous research is needed to guide health care-based S&R efforts. Funded by the Veteran Health Administration (VA), the study described in this paper will assess the efficacy of S&R on Veterans’ connections to new resources to address social needs, reduction of unmet needs and health-related outcomes (adherence, utilisation and clinical outcomes).

Methods and analysis
We will conduct a 1-year mixed-methods randomised controlled trial at three VA sites, enrolling Veterans with CVD and CVD-risk. 880 Veterans experiencing one or more social needs will be randomised within each site (n=293 per site) to one of three study arms representing referral mechanisms of varying intensity (screening only, screening and provision of resource sheet(s), screening and provision of resource sheet(s) plus social work assistance). For each Veteran, we will examine associations of unmet social needs with health-related outcomes at baseline, and longitudinally compare the impact of each approach on connection to new resources (primary outcome) and follow-up outcomes over a 12-month period. We will additionally conduct qualitative interviews with key stakeholders, including Veterans to identify potential explanatory factors related to the relative success of the interventions.

Ethics and dissemination
Ethics approval was obtained from the VA Central Internal Review Board on 13 July 2021 (reference #: 20-07-Amendment No. 02). Findings will be disseminated through reports, lay summaries, policy briefs, academic publications, and conference presentations.

Trial registration number
NCT04977583.

Introduction
Work-related asthma (WRA) refers to asthma caused by exposures at work (occupational asthma) and asthma made worse by work conditions (work-exacerbated asthma). WRA is common among working-age adults with asthma and impacts individual health, work–life and income but is often not detected by healthcare services. Earlier identification can lead to better health and employment outcomes. However, the optimal tool for screening and its effectiveness in practice is not well established. Screening tools may include whole questionnaires, questionnaire items, physiological measurements and/or immunological tests. Since the publication of the most contemporary WRA or occupational asthma-specific guidelines, further studies evaluating tools for identifying WRA have been performed. Our systematic review aims to summarise and compare the performance of screening tools for identifying WRA in both clinical and workplace settings.

Methods and analysis
We will conduct a systematic review of observational and experimental studies (1975–2021) using MEDLINE, EMBASE, CINAHL Plus, Web of Science, CDSR, DARE, HTA, CISDOC databases and grey literature. Two independent reviewers will screen the studies using predetermined criteria, extract data according to a schedule and assess study quality using the Quality Assessment of Diagnostic Test Accuracy 2 tool. Screening tools and test accuracy measures will be summarised. Paired forest plots and summary receiver operating characteristic curves of sensitivities and specificities will be evaluated for heterogeneity between studies, using subgroup analyses, where possible. If the studies are sufficiently homogenous, we will use a bivariate random effect model for meta-analysis. A narrative summary and interpretation will be provided if meta-analysis is not appropriate.

Ethics and dissemination
As this is a systematic review and does not involve primary data collection, formal ethical review is not required. We will disseminate our findings through open access peer-reviewed publication as well as through other academic and social media.

PROSPERO registration number
CRD42021246031.

Introduction
The participation rate is higher in breast cancer screening than in cervical cancer (CCU) and colorectal cancer (CRC) screening. In this cluster-randomised study, we aim to evaluate an intervention offering home-based CCU and CRC screening to women when attending breast cancer screening if they are overdue for CCU and/or CRC screening.

Methods and analysis
On intervention days, one of the five breast cancer screening units in the Central Denmark Region will be randomly allocated to intervention, whereas the remaining units will serve as control. Women attending breast cancer screening in the intervention unit will be offered information regarding their CCU and CRC screening history, and, if overdue, they will be offered self-sampling screening kits. For CCU screening, women aged 50–64 years will be offered a vaginal self-sampling kit for human papillomavirus testing. For CRC screening, women aged 50–69 years will be offered a kit to obtain a faecal immunochemical test. Women attending the control units will receive only standard care.
After the intervention, a survey will be sent to all women in the intervention and control group, asking about their experience while attending breast cancer screening.
Primary outcomes will be difference in the coverage in CCU and CRC screening 6 months after intervention between the intervention and the control group, and difference in participation rates 6 months after intervention for those who were overdue for CCU and/or CRC screening at the time of the intervention.

Ethics and dissemination
The project is listed in the record of processing activities for research projects in the Central Denmark Region (R. No.: 1-16-02-217-21). According to the Danish Consolidation Act on Research Ethics Review of Health Research Project, this study was not notifiable to the Committee (R. No.: 1-10-72-1-21). The findings will be disseminated in peer-reviewed scientific journals.

Trial registration number
NCT05022511.

Introduction
Preterm infants are at risk of negative consequences from stress and pain at the same time as they often are in need of intensive care that includes painful interventions. One of the frequent painful procedures preterm infants undergo is eye examination screening to detect early signs of ROP (retinopathy of prematurity). These examinations are both stressful and painful, and despite a multitude of research studies, no conclusive pain-relieving treatment has been demonstrated. The main aim of this trial is to investigate the analgesic effect of clonidine during ROP eye examinations.

Methods and analysis
The planned study is a multicentre randomised controlled trial with a crossover design. Infants will be recruited from two different neonatal intensive care units (NICUs) in Sweden. Infants born before gestation week 30 (and therefore eligible for ROP screening) and cared for in either of the NICUs will be eligible for inclusion in the study. The primary outcome will be Premature Infant Pain Profile–Revised score within 30 s after starting the examination. Secondary outcomes will be changes in the galvanic skin response parameters (area small peaks, area huge peaks, peaks per second and average rise time) within 30 s after starting the eye examination, together with the number and evaluation of adverse events reported within 72 hours after the examination and the examining physician’s assessment of how easy the infant was to examine.

Ethics and dissemination
Approval from the Swedish Ethical Review Authority and the Swedish Medical Products Agency has been obtained for the study. Parents of eligible infants will be getting both verbal and written information about the study including that participation is voluntary. Data will be collected and treated in accordance with the European general data protection regulations. The results will be reported on group level and published in a scientific journal.

Trial registration number
ClinicalTrials.gov (NCT04902859).
EudraCT (2021-003005-21).

Objectives
Low-dose CT (LDCT) can help determine the early stage of lung cancer and reduce mortality. However, knowledge of lung cancer and lung cancer screening among community residents and medical workers, and potential factors that may affect medical institutions to set up LDCT are limited.

Design
A cross-sectional study was conducted in Sichuan province, China, in 2021. Community residents, medical workers and medical institutions were randomly selected, and participants responded to related questionnaires. Knowledge of lung cancer and LDCT lung cancer screening was evaluated. Data analyses were performed using SAS V.9.4.

Results
A total of 35 692 residents, 6350 medical workers and 81 medical institutions were recruited; 4.05% of the residents were very familiar with lung cancer and 37.89% were (completely) unfamiliar. Characteristics, such as age and level of education, were significantly related to residents who were very familiar with lung cancer. Furthermore, 22.87% of the residents knew that LDCT can effectively screen for early-stage lung cancer, which was correlated with smoking (OR 1.1300; 95% CI 1.0540 to 1.2110; p=0.006) and family history of cancer (OR 1.2210; 95% CI 1.1400 to 1.3080; p

Introduction
Kidney cancer (renal cell cancer (RCC)) is the seventh most common cancer in the UK. As RCC is largely curable if detected at an early stage and most patients have no symptoms, there is international interest in evaluating a screening programme for RCC. The Yorkshire Kidney Screening Trial (YKST) will assess the feasibility of adding non-contrast abdominal CT scanning to screen for RCC and other abdominal pathology within the Yorkshire Lung Screening Trial (YLST), a randomised trial of community-based CT screening for lung cancer.

Methods and analysis
In YLST, ever-smokers aged 55–80 years registered with a general practice in Leeds have been randomised to a Lung Health Check assessment, including a thoracic low-dose CT (LDCT) for those at high risk of lung cancer, or routine care. YLST participants randomised to the Lung Health Check arm who attend for the second round of screening at 2 years without a history of RCC or abdominal CT scan within the previous 6 months will be invited to take part in YKST. We anticipate inviting 4700 participants. Those who consent will have an abdominal CT immediately following their YLST thoracic LDCT. A subset of participants and the healthcare workers involved will be invited to take part in a qualitative interview. Primary objectives are to quantify the uptake of the abdominal CT, assess the acceptability of the combined screening approach and pilot the majority of procedures for a subsequent randomised controlled trial of RCC screening within lung cancer screening.

Ethics and dissemination
YKST was approved by the North West-Preston Research Ethics Committee (21/NW/0021), and the Health Research Authority on 3 February 2021. Trial results will be disseminated at clinical meetings, in peer-reviewed journals and to policy-makers. Findings will be made available to participants via the study website (www.YKST.org).

Trial registration numbers
NCT05005195 and ISRCTN18055040.

Objectives
To investigate the acceptability of a text message intervention and evaluate if text messages could increase knowledge of cervical cancer and screening.

Design
This study was a substudy of a randomised controlled trial that used a mixed methods research design combining a quantitative questionnaire dataset and qualitative interview data. A before and after assessment was made of questionnaire responses. Acceptability was measured on a 6-point Likert scale and knowledge was measured through 16 binary true/false knowledge questions concerning cervical cancer and screening. Qualitative data were coded using a combined inductive–deductive approach.

Setting
Ocean Road Cancer Institute in Dar es Salaam as well as Kilimanjaro Christian Medical Center and Mawenzi Regional hospital in the Kilimanjaro Region in Tanzania.

Participants
Human papillomavirus (HPV) positive women who had been randomised to the intervention group and received educative and reminder messages. Qualitative interviews were conducted with a subgroup of women in the intervention group.

Interventions
15 one-way educative and reminder text messages.

Results
A total of 115 women in the intervention group responded to both the baseline and follow-up questionnaire. Overall, women found it highly acceptable to receive text messages, and there was a trend towards acceptability rising between baseline and follow-up (mean: 0.22; 95% CI 0.00 to 0.44; p=0.05; t-statics=1.96). A significant increase in acceptability was found among the lowest educated and those who had not previously been screened. The qualitative interviews showed that the underlying reasons for the high acceptability rate were that the women felt someone cared for them and that the text messages were for their own benefits. The text messages did not improve the women’s knowledge on cervical cancer and screening.

Conclusions
Educative and reminder text messages are highly acceptable among HPV-positive Tanzanian women; however, they do not increase the women’s knowledge of cervical cancer and screening.

Trial registration number
clingov (NCT02509702).

Decompensation events, such as portal hypertensive bleeding, are associated with increased morbidity and mortality among persons living with cirrhosis. Current practice guidelines recommend surveillance for esophageal varices in the setting of clinically significant portal hypertension. The Advanced Liver Disease Dashboard (ALDD) is a national online database developed and maintained by the Department of Veterans Affairs (VA) to facilitate tracking of hepatocellular cancer and esophageal variceal surveillance exams.

Colorectal cancer is the fourth most common cause of cancer in the United States with an incidence of 36.5/100,000 people and a mortality rate of 13.1/100,000 people. Colonoscopies are the gold standard for detection and prevention of colorectal cancers. Successful colonoscopy can be limited by inadequate bowel preparation, which can prolong procedure time, decrease efficiency, and require the use of intra-procedural simethicone to improve visualization. Simethicone via irrigation channel may lead to formation of biofilms in colonoscopes rendering them more challenging to clean and process, and an endoscope manufacturer has recommended against its use.

Inflammatory bowel disease (IBD) is associated with an increased risk of malnutrition and micronutrient deficiencies due to chronic enteric losses, malabsorption, food avoidance, and prior surgery. Malnutrition affects 20-80% of patients with IBD and is associated with poor clinical outcomes. Despite its high prevalence, few patients with IBD are screened for malnutrition. Through a quality improvement (QI) initiative, we aimed to institute a screening intervention to improve screening and management of IBD patients identified as high-risk for malnutrition.

Objectives
There are several clinical practice guidelines available for peripheral artery disease (PAD). The paucity of strong evidence is known to give room for variations in recommendations across guidelines, with attendant confusion among clinicians in clinical practice. This study aims to conduct a quality assessment and comparative analysis on PAD screening and diagnostic recommendations in PAD management.

Selection
Clinical practice guidelines written after 2010 and on or before 2020 were targeted. An exhaustive search was conducted through the major medical databases and websites of specialist international organisations of interest, and selection was made using our inclusion/exclusion criteria.

Setting
Global. All guidelines written in English were included in this study.

Selected guidelines
Nine guidelines were selected.

Outcomes
The primary outcomes were the guidelines’ quality and variations in screening and diagnostic recommendations in the selected guidelines.

Results
Regarding quality, the guidelines had the lowest scores across the applicability and stakeholder involvement domains with means (SD) of 62 (9.9) and 65.3 (13), respectively. The highest score was clarity of presentation, with a mean (SD) of 86.8 (5.1). Also, the trend showed guideline quality scores improved over time. The guidelines unanimously offered to screen ‘high-risk’ patients, although there were some discrepancies in the appropriate age range and unavailability of strong evidence backing this recommendation. The guidelines harmoniously adopted the Ankle-Brachial Index as the initial diagnostic investigation of choice. However, concerning further diagnostic investigations and imaging, we found several discrepancies among the recommendations in the absence of strong evidence.

Conclusion
Though the quality of the guidelines is shown to be improving over time, they perform poorly in stakeholder involvement and applicability domains, which could be influencing interest in research revolving around screening and diagnostic recommendations. Involving primary care providers and the public can be a possible solution.

PROSPERO registration number
CRD42020219176.

Annals of Internal Medicine, Volume 175, Issue 10, Page 1383-1391, October 2022.

Objectives
To compare the accuracy of trained level 1 diabetic retinopathy (DR) graders (nurses, endocrinologists and one general practitioner), level 2 graders (midlevel ophthalmologists) and level 3 graders (senior ophthalmologists) in Vietnam against a reference standard from the UK and assess the impact of supplementary targeted grader training.

Design
Diagnostic test accuracy study.

Setting
Secondary care hospitals in Southern Vietnam.

Participants
DR training was delivered to Vietnamese graders in February 2018 by National Health Service (NHS) UK graders. Two-field retinal images (412 patient images) were graded by 14 trained graders in Vietnam between August and October 2018 and then regraded retrospectively by an NHS-certified reference standard UK optometrist (phase I). Further DR training based on phase I results was delivered to graders in November 2019. After training, a randomised subset of images from January to October 2020 (115 patient images) was graded by six of the original cohort (phase II). The reference grader regraded all images from phase I and II retrospectively in masked fashion.

Primary and secondary outcome measures
Sensitivity was calculated at the two different time points, and 2 was used to test significance.

Results
In phase I, the sensitivity for detecting any DR for all grader groups in Vietnam was low (41.8–42.2%) and improved in phase II after additional training was delivered (51.3–87.2%). The greatest improvement was seen among level 1 graders (p

Introduction
Atrial fibrillation (AF) is a common arrhythmia associated with 30% of strokes, as well as other cardiovascular disease, dementia and death. AF meets many criteria for screening, but there is limited evidence that AF screening reduces stroke. Consequently, no countries recommend national screening programmes for AF. The Screening for Atrial Fibrillation with ECG to Reduce stroke (SAFER) trial aims to determine whether screening for AF is effective at reducing risk of stroke. The aim of the pilot study is to assess feasibility of the main trial and inform implementation of screening and trial procedures.

Methods and analysis
SAFER is planned to be a pragmatic randomised controlled trial (RCT) of over 100 000 participants aged 70 years and over, not on long-term anticoagulation therapy at baseline, with an average follow-up of 5 years. Participants are asked to record four traces every day for 3 weeks on a hand-held single-lead ECG device. Cardiologists remotely confirm episodes of AF identified by the device algorithm, and general practitioners follow-up with anticoagulation as appropriate. The pilot study is a cluster RCT in 36 UK general practices, randomised 2:1 control to intervention, recruiting approximately 12 600 participants. Pilot study outcomes include AF detection rate, anticoagulation uptake and other parameters to incorporate into sample size calculations for the main trial. Questionnaires sent to a sample of participants will assess impact of screening on psychological health. Process evaluation and qualitative studies will underpin implementation of screening during the main trial. An economic evaluation using the pilot data will confirm whether it is plausible that screening might be cost-effective.

Ethics and dissemination
The London—Central Research Ethics Committee (19/LO/1597) and Confidentiality Advisory Group (19/CAG/0226) provided ethical approval. Dissemination will be via publications, patient-friendly summaries, reports and engagement with the UK National Screening Committee.

Trial registration number
ISRCTN72104369.

Objective
Colorectal screening using faecal immunochemical tests (FITs) can save lives if the people invited participate. In Scotland, most people intend to complete a FIT but this is not reflected in uptake rates. Planning interventions can bridge this intention-behaviour gap. To develop a tool supporting people willing to do colorectal screening with planning to complete a FIT, this study aimed to identify frequently experienced barriers and solutions to these barriers.

Design
This is a cross-sectional study.

Setting
Participants were recruited through the Scottish Bowel Screening Programme to complete a mailed questionnaire.

Participants
The study included 2387 participants who had completed a FIT (mean age 65 years, 40% female) and 359 participants who had not completed a FIT but were inclined to do so (mean age 63 years, 39% female).

Outcome measures
The questionnaire assessed frequency of endorsement of colorectal screening barriers and solutions.

Results
Participants who had not completed a FIT endorsed significantly more barriers than those who had completed a FIT, when demographic, health and behavioural covariates were held constant (F(1,2053)=13.40, p