Yorkshire Lung Screening Trial (YLST) pathway navigation study: a protocol for a nested randomised controlled trial to evaluate the effect of a pathway navigation intervention on lung cancer screening uptake

Introduction
Lung cancer is the most common cause of cancer death globally. In 2022 the UK National Screening Committee recommended the implementation of a national targeted lung cancer screening programme, aiming to improve early diagnosis and survival rates. Research studies and services internationally consistently observe socioeconomic and smoking-related inequalities in screening uptake. Pathway navigation (PN) is a process through which a trained pathway navigator guides people to overcome barriers to accessing healthcare services, including screening. This nested randomised controlled trial aims to determine whether a PN intervention results in more individuals participating in lung cancer screening compared with the usual written invitation within a previous non-responder population as part of the Yorkshire Lung Screening Trial (YLST).

Methods and analysis
A two-arm randomised controlled trial and process evaluation nested within the YLST. Participants aged 55–80 (inclusive) who have not responded to previous postal invitations to screening will be randomised by household to receive PN or usual care (a further postal invitation to contact the screening service for a lung health check) between March 2023 and October 2024. The PN intervention includes a postal appointment notification and prearranged telephone appointment, during which a pathway navigator telephones the participant, following a four-step protocol to introduce the offer and conduct an initial risk assessment. If eligible, participants are invited to book a low-dose CT (LDCT) lung cancer screening scan. All pathway navigators receive training from behavioural psychologists on motivational interviewing and communication techniques to elicit barriers to screening attendance and offer solutions.

Coprimary outcomes
The number undergoing initial telephone assessment of lung cancer risk. The number undergoing an LDCT screening scan.
Secondary outcomes include demographic, clinical and risk parameters of people undergoing telephone risk assessment; the number of people eligible for screening following telephone risk assessment; the number of screen-detected cancers diagnosed; costs and a mixed-methods process evaluation.
Descriptive analyses will be used to present numbers, proportions and quantitative components of the process evaluation. Primary comparisons of differences between groups will be made using logistic regression. Applied thematic analysis will be used to interpret qualitative data within a conceptual framework based on the COM-B framework. A health economic analysis of the PN intervention will also be conducted.

Ethics and dissemination
The study is approved by the Greater Manchester West Research Ethics Committee (18-NW-0012) and the Health Research Authority following the Confidentiality Advisory Group review. Results will be shared through peer-reviewed scientific journals, conference presentations and on the YLST website.

Trial registration numbers
ISRCTN42704678 and NCT03750110.

Leggi
Luglio 2024

The Interval for Screening Colonoscopy—Is 15 the New 10?

Most colorectal cancers (CRCs) develop via the adenoma-carcinoma sequence, a stepwise process characterized by mutations in healthy tissue that accumulate in the progression from adenomatous polyps to cancer. First coined the polyp-cancer sequence nearly a century ago, it is widely believed that the contemporary concept was first used by Jackman and Mayo in 1951. Even before more modern sequencing technology facilitated the elucidation of the underlying molecular mechanisms, it was well understood that this process is typically slow, generally taking approximately 10 years. This time frame is the empirical basis for most current colorectal cancer screening guidelines that endorse a 10-year interval after a colonoscopy with no abnormal findings.

Leggi
Luglio 2024

Is Screening for Primary Aldosteronism Always the Best Option?

To the Editor Patients with hypertension and primary aldosteronism (PA) face a grim prognosis in the absence of specific therapy; they must be promptly identified and managed. Charoensri et al reported on an enhanced effective screening rate for this population, reaching up to 9.9%, through an artificial intelligence−based best practice advisories system that identifies patients who are at high-risk for PA for clinicians. Although this is an improvement compared with the commonly reported 2% to 4% rate, screening remained infrequent even in this study context, with 90.1% of patients who were identified as being at high risk not undergoing screening. Some may perceive this as a failure, but we believe a critical outcome is absent, hindering a proper evaluation of the intervention’s effectiveness.

Leggi
Luglio 2024

Is Screening for Primary Aldosteronism Always the Best Option?—Reply

In Reply We appreciate the perspective from Boulestreau and Couffinhal on our recent initiative to enhance screening for primary aldosteronism (PA) by leveraging electronic health records capabilities. We designed and implemented an advisory that identifies PA screening candidates and assists clinicians with test ordering and interpretation. Boulestreau and Couffinhal suggest empirical use of mineralocorticoid receptor antagonists (MRA) to treat patients with possible PA as a more pragmatic alternative to PA screening.

Leggi
Luglio 2024

Implementation of First-trimester Screening and Prevention of Preeclampsia: a Stepped Wedge Cluster-randomized Trial in Asia

Circulation, Ahead of Print. Background: This trial aimed to assess the efficacy, acceptability and safety of a first-trimester screen-and-prevent strategy for preterm preeclampsia (PE) in Asia.Methods: Between 1stAugust 2019 and 28thFebruary 2022, this multicenter stepped wedge cluster randomized trial included maternity/diagnostic units from ten regions in Asia. The trial started with a period where all recruiting centers provided routine antenatal care without study-related intervention. At regular six-week intervals, one cluster was randomized to transit from non-intervention phase to intervention phase. In the intervention phase, women underwent first-trimester screening for preterm PE using a Bayes theorem-based triple-test. High-risk women, with adjusted risk for preterm PE ≥ 1 in 100, received low-dose aspirin from

Leggi
Giugno 2024

Comparing the effectiveness and cost-effectiveness of text-message reminders and telephone patient navigation to improve the uptake of faecal immunochemical test screening among non-responders in London: a randomised controlled trial protocol

Introduction
Participation in bowel cancer screening is lower in regions where there is high ethnic diversity and/or socioeconomic deprivation. Interventions, such as text message reminders and patient navigation (PN), have the potential to increase participation in these areas. As such, there is interest in the comparative effectiveness of these interventions to increase bowel cancer screening participation, as well as their relative cost-effectiveness.

Methods and analysis
This study will use a three-arm randomised controlled trial design to compare the effectiveness and cost-effectiveness of text message reminders and PN to increase the uptake of bowel cancer screening in London. Participants will be individuals who have not returned a completed faecal immunochemical test kit within 13 weeks of receiving a routine invitation from the London bowel cancer screening hub. Participants will be randomised (in a 1:1:1 ratio) to receive either (1) usual care (ie, ‘no intervention’), (2) a text message reminder at 13 weeks, followed by repeated text message reminders at 15, 17 and 19 weeks (in the event of non-response) or (3) a text message reminder at 13 weeks, followed by PN telephone calls at 15, 17 and 19 weeks in the event of non-response. The primary endpoint will be participation in bowel cancer screening, defined as ‘the return of a completed kit by week 24’. Statistical analysis will use multivariate logistic regression and will incorporate pairwise comparisons of all three groups, adjusted for multiple testing.

Ethics and dissemination
Approvals to conduct the research have been obtained from University College London’s Joint Research Office (Ref: 150666), the Screening Research, Innovation and Development Advisory Committee (‘RIDAC’, Ref: 2223 014 BCSP Kerrison), the Health Research Authority (Ref: 22/WM/0212) and the Confidentiality Advisory Group (Ref: 22/CAG/0140). Results will be conveyed to stakeholders, notably those managing the screening programme and published in peer-reviewed journals/presented at academic conferences.

Trial registration number
ISRCTN17245519

Leggi
Giugno 2024

Is screening for motor skill deficits in Tyrolean preschool children warranted and feasible? A protocol for a two-stage cross-sectional study

Introduction
Children with developmental coordination disorder (DCD) show deviations in motor development and motor skills in early childhood where the learning and execution of coordinated motor skills are below the level expected for their age. Early detection of DCD is critical to provide an opportunity for intervention and support, yet many cases remain undetected until school age. The study described aims to determine the warranty, feasibility and validity of a mobility screening in Tyrolean kindergartens and evaluate its potential benefit to enhance the motor development prospects of affected children.

Methods and analysis
This research employs a two-stage cross-sectional approach with 6 months of follow-up assessments. The initial stage involves a playful mobility screening for all participating kindergarten children, followed by individual assessments for those displaying conspicuous motor skills. Motor skills will be evaluated using MobiScreen 4–6 and the Movement Assessment Battery for Children-2. Prior to the screening, informed consent is obtained from kindergarten bodies and authorities, parents and the children themselves. Parents are provided with information sheets and questionnaires to assess their attitudes and their child’s eligibility. The study described aims to form a representative sample of kindergarten children, aged 4–6, in Tyrol. To target approximately 20–40 children with DCD for follow-up, the goal is to include 650 children, assuming an incidence of 3%–6%. For the follow-up, matching control groups will be formed and information about how identified motor deficits were addressed, including therapies or sports, will be gathered. Quantitative data will mainly be analysed descriptively, while feedback from kindergarten teachers regarding the practical implementation will be analysed using qualitative content analyses, according to Mayring.

Ethics and dissemination
The study has been approved by the Research Committee for Scientific Ethical Questions (RCSEQ 3369/24). Findings will be disseminated through contributions, peer-reviewed journals, and conferences.

Leggi
Giugno 2024

Screening for adverse social conditions in child healthcare settings: protocol for a systematic review

Introduction
Adverse social conditions affect children’s development and health outcomes from preconception throughout their life course. Early identification of adverse conditions is essential for early support of children and their families. Healthcare contacts with children provide a unique opportunity to screen for adverse social conditions and to take preventive action to identify and address emerging, potentially harmful or accumulating social problems. The aim of our study is to identify and describe available screening tools in outpatient and inpatient healthcare settings that capture social conditions that may affect children’s development, health or well-being.

Methods and analysis
We will conduct a systematic review and will report the results following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidance. A systematic search of three databases (PubMed (Ovid), PsycInfo (EBSCOhost) and Web of Science Core Collection (Clarivate)) for English-language and German-language articles from 2014 to date will be conducted. We will include peer-reviewed articles that develop, describe, test or use an instrument to screen children for multiple social conditions in paediatric clinics or other outpatient or inpatient child healthcare settings. Key study characteristics and information on screening tools will be extracted and presented in structured tables to summarise the available evidence. We will assess the methodological quality of the instruments with the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) checklist.

Ethics and dissemination
Ethical approval is not required for this study as we will not be collecting any personal data. Dissemination will consist of publications, presentations, and other knowledge translation activities.

Leggi
Giugno 2024

Standardised protocol for a prospective international multicentre clinical-based evaluation of point-of-care tests for the screening of genital and extragenital chlamydial and gonococcal infections in men who have sex with men and for the screening of genital chlamydial, gonococcal and Trichomonas vaginalis infections in at risk women

Introduction
In 2016, WHO estimated there were roughly 374 million new infections among adults of the following four curable sexually transmitted infections (STIs): chlamydia (caused by Chlamydia trachomatis (CT)), gonorrhoea (Neisseria gonorrhoeae (NG)), syphilis (Treponema pallidum) and trichomoniasis (Trichomonas vaginalis (TV)). Accurate point-of-care tests (POCTs) for screening of genital and extragenital CT, NG and TV infections are of great value and have been developed during recent decade. Several tests are commercially available and have shown encouraging performance compared with ‘gold-standard’ reference tests in laboratory-based studies. However, there is limited data on their clinical performance, including at the POC. Key populations, such as men who have sex with men (MSM), are at higher risk of these STIs at genital and extragenital sites and these STIs are often asymptomatic, especially in extragenital sites and in women. We will conduct a clinical-based evaluation to assess the performance characteristics and acceptability to end-users of molecular-based diagnostic technology for POC/near patient use of the Xpert CT/NG (Cepheid, Sunnyvale, California, USA) test for screening of genital, anorectal and pharyngeal CT and NG infections in MSM and the Xpert CT/NG and Xpert TV (Cepheid, Sunnyvale, California, USA) for screening of genital CT, NG and TV among women at risk for these STIs compared with gold-standard reference nucleic acid amplification tests. This master protocol outlines the overall research approach that will be used in seven countries.

Method and analyses
Consecutive MSM and women at risk presenting at the clinical sites in high, and low- and middle-income countries will be enrolled. The POCTs to be evaluated are Xpert CT/NG and Xpert TV. All procedures will be carried out by trained healthcare staff and tests performed in strict accordance with the manufacturer’s instructions. The sensitivity, specificity, positive and negative predictive values for each POCT will be calculated. The study is ongoing with recruitment expected to be completed in all countries by mid-2022 to late-2022.

Ethics and dissemination
Prior to enrolment, this core protocol was independently peer-reviewed and approved by the research project review panel (RP2) of the WHO Department of Sexual and Reproductive Health and Research and by the WHO Ethics Review Committee (ERC). The core protocol has been slightly adapted accordingly to individual countries and adaptations approved by both RP2 and ERC, as well as all relevant institutional review boards at each participating site. Results will be disseminated through peer-reviewed journals and presented at relevant national/international conferences.

Leggi
Giugno 2024

Can the 128-Hz tuning fork be an alternative to the biothesiometer for diabetic peripheral neuropathy screening? A cross-sectional study in a tertiary hospital in East India

Introduction
Diabetic neuropathy is frequently underdiagnosed and undertreated. Logistic problems accompany the routine use of the biothesiometer. Hence, we attempted to find a more easily available alternative.

Research design and methods
149 patients with diabetes visiting the outpatient endocrinology clinic were assessed for vibration sense using a 128-Hz tuning fork (absolute timing method) and a biothesiometer. A reading of >25 V on the biothesiometer (known as vibration perception threshold or VPT) was taken as the diagnostic criterion for severe neuropathy while >15 V was used as an indicator of the mild form. The sensitivity and specificity were calculated by constructing the receiver operating characteristic curve (ROC). A p value of

Leggi
Giugno 2024