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This report of 2 randomized clinical trials evaluates whether bulk ordering, text messaging, and clinician endorsement increase breast cancer screening rates.
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.
In Lombardia uno studio pilota promosso da Telethon coinvolgerà 100mila neonati. Obiettivo: validare il test per la diagnosi di leucodistrofia metacromatica
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
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
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.
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.
New England Journal of Medicine, Volume 390, Issue 23, Page 2222-2225, June 20, 2024.
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.
New England Journal of Medicine, Volume 390, Issue 22, June 13, 2024.
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
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.
This systematic review to support a 2024 US Preventive Services Task Force Recommendation Statement summarizes published evidence on the benefits and harms of screening for breast cancer in adult females.
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.
In this JAMA Patient Page, the US Preventive Services Task Force provides a guide to screening for breast cancer.
