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

Zipime-Weka-Schista study protocol: a longitudinal cohort study and economic evaluation of an integrated home-based approach for genital multipathogen screening in women, including female genital schistosomiasis, human papillomavirus, Trichomonas and HIV in Zambia

Introduction
Multiplathogen home-based self-sampling offers an opportunity to increase access to screening and treatment in endemic settings with high coinfection prevalence of sexually transmitted (HIV, Trichomonas vaginalis (Tv), human papillomavirus (HPV)) and non-sexually transmitted pathogens (Schistosoma haematobium (Sh)). Chronic coinfections may lead to disability (female genital schistosomiasis) and death (cervical cancer). The Zipime-Weka-Schista (Do self-testing sister!) study aims to evaluate the validity, acceptability, uptake, impact and cost-effectiveness of multipathogen self-sampling for genital infections among women in Zambia.

Methods and analysis
This is a longitudinal cohort study aiming to enrol 2500 non-pregnant, sexually active and non-menstruating women aged 15–50 years from two districts in Zambia with 2-year follow-up. During home visits, community health workers offer HIV and Tv self-testing and cervicovaginal self-swabs for (1) HPV by GeneXpert and, (2) Sh DNA detection by conventional (PCR)and isothermal (recombinase polymerase assay) molecular methods. Schistosoma ova and circulating anodic antigen are detected in urine. At a clinic follow-up, midwives perform the same procedures and obtain hand-held colposcopic images. High-risk HPV positive women are referred for a two-quadrant cervical biopsy according to age and HIV status. A cost-effectiveness analysis is conducted in parallel.

Ethics and dissemination
The University of Zambia Biomedical Research Ethics Committee (UNZABREC) (reference: 1858-2021), the London School of Hygiene and Tropical Medicine (reference: 25258), Ministry of Health and local superintendents approved the study in September 2021.Written informed consent was obtained from all participants prior to enrolment. Identifiable data collected are stored securely and their confidentiality is protected in accordance with the Data Protection Act 1998.

Leggi
Giugno 2024

USPSTF Recommendation: Screening for Breast Cancer

This 2024 Recommendation Statement from the US Preventive Services Task Force recommends biennial screening mammography for women aged 40 to 74 years (B recommendation) and concludes that evidence is insufficient to assess the balance of benefits and harms of screening mammography in women 75 years or older (I statement) and of screening using ultrasonography or MRI in women with dense breasts on a negative mammogram (I statement).

Leggi
Giugno 2024

Late-Stage Cancer End Points to Speed Cancer Screening Clinical Trials—Not So Fast

In this issue of JAMA, Feng et al studied whether late-stage cancer (ie, stage III or stage IV cancer), rather than cancer-specific mortality, was an acceptable alternative end point in clinical trials of cancer screening. The authors analyzed 41 clinical trials conducted in Europe, North America, and Asia, combining the data overall and according to cancer type. They evaluated the association between incidence of stage III-IV cancer and cancer-specific mortality in and across the selected studies.

Leggi
Giugno 2024

Development of a risk prediction score for screening for HBV, HCV and HIV among migrants in France: results from a multicentre observational study (STRADA study)

Objectives
Migrants from high HIV, hepatitis B virus (HBV) or hepatitis C virus (HCV) endemicity regions have a great burden of these infections and related diseases in the host countries. This study aimed to assess the predictive capacity of the Test Rapide d’Orientation Diagnostique (TROD) Screen questionnaire for HIV, HBV and HCV infections among migrants arriving in France.

Design
An observational and multicentre study was conducted among migrants. A self-questionnaire on demographic characteristics, personal medical history and sexual behaviours was completed.

Setting
The study was conducted in the centres of the French Office for Immigration and Integration (OFII).

Participants
Convenience sampling was used to select and recruit adult migrants between January 2017 and March 2020.

Outcome measures
Participants were tested for HIV, HBV and HCV with rapid tests. For each infection, the test performance was assessed using receiver operating characteristics curves, using area under the curve (AUC) as a measure of accuracy.

Results
Among 21 133 regular migrants seen in OFII centres, 15 343 were included in the study. The participants’ mean age was 35.6 years (SD±11.1). The prevalence (95% CI) of HBV, HCV and HIV was 2.0% (1.8% to 2.2%), 0.3% (0.2% to 0.4%) and 0.3% (0.2% to 0.4%), respectively. Based on the sensitivity–specificity curve analysis, the cut-off points (95% CI) chosen for the risk score were: 2.5 (2.5 to 7.5) for HBV infection in men; 6.5 (0.5 to 6.5) for HBV infection in women; 9.5 (9.5 to 12.5) for HCV infection; and 10.5 (10.0 to 18.5) for HIV infection. Test performance was highest for HIV (AUC=82.15% (95% CI 74.54% to 87.99%)), followed by that for HBV in men (AUC=79.22%, (95% CI 76.18% to 82.26%)), for HBV in women (AUC=78.83 (95% CI 74.54% to 82.10%)) and that for HCV (AUC=75.95% (95% CI 68.58% to 83.32%)).

Conclusion
The TROD screen questionnaire showed good overall performance for predicting HIV, HBV and HCV infections among migrants in OFII centres. It could be used to optimise screening for these infections and to propose rapid screening tests to those who are at high risk.

Trial registration number
NCT02959684.

Leggi
Giugno 2024