Implementation of a colorectal cancer screening intervention in Malaysia (CRC-SIM) in the context of a pandemic: study protocol

Introduction
Colorectal cancer (CRC) is the second most common cancer in Malaysia and cases are often detected late. Improving screening uptake is key in down-staging cancer and improving patient outcomes. The aim of this study is to develop, implement and evaluate an intervention to improve CRC screening uptake in Malaysia in the context of the COVID-19 pandemic. The evaluation will include ascertaining the budgetary impact of implementing and delivering the intervention.

Methods and analysis
The implementation research logic model guided the development of the study and implementation outcome measures were informed by the ‘Reach, Effectiveness, Adoption, Implementation and Maintenance’ (RE-AIM) framework. This CRC screening intervention for Malaysia uses home-testing and digital, small media, communication to improve CRC screening uptake. A sample of 780 people aged 50–75 years living in Segamat district, Malaysia, will be selected randomly from the South East Asia Community Observatory (SEACO) database. Participants will receive a screening pack as well as a WhatsApp video of a local doctor to undertake a stool test safely and to send a photo of the test result to a confidential mobile number. SEACO staff will inform participants of their result. Quantitative data about follow-up clinic attendance, subsequent hospital tests and outcomes will be collected. Logistic regression will be used to investigate variables that influence screening completion and we will conduct a budget impact-analysis of the intervention and its implementation. Qualitative data about intervention implementation from the perspective of participants and stakeholders will be analysed thematically.

Ethics and dissemination
Ethics approval has been granted by Monash University Human Research Ethics Committee (MUHREC ID: 29107) and the Medical Review and Ethics Committee (Reference: 21-02045-O7G(2)). Results will be disseminated through publications, conferences and community engagement activities.

Trial registration number
National Medical Research Register Malaysia: 21-02045-O7G(2).

Leggi
Settembre 2022

Development of a screening tool for the need of specialist palliative care in oncologic inpatients: study protocol for the ScreeningPALL Study

Introduction
A range of referral criteria and scores have been developed in recent years to help with screening for the need of specialist palliative care (SPC) in advanced, incurable cancer patients. However, referral criteria have not yet been widely implemented in oncology, as they usually need to be revised by physicians or nurses with limited time resources. To develop an easily applicable screening for the need for SPC in incurable cancer inpatients, we aim to (a) test inter-rater reliability of multiprofessional expert opinion as reference standard for SPC need (phase I) and (b) explore the diagnostic validity of selected patient-reported outcome measures (PROMs) and routine data for the need of SPC (phase II).

Methods and analysis
Inclusion criteria for patients are metastatic or locally advanced, incurable cancer, ≥18 years of age and informed consent by patient or proxy. (Exclusion criteria: malignant haematological disease as main diagnosis). In phase I, three palliative care consultation teams (PCTs) of three German university hospitals assess the SPC need of 20 patient cases. Fleiss’ Kappa will be calculated for inter-rater reliability. In phase II, 208 patients are consecutively recruited in four inpatient oncology wards of Freiburg University Hospital. The PCT will provide assessment of SPC need. As potential referral criteria, patients complete PROMs and a selection of routine data on person, disease and treatment is documented. Logistic regression models and ROC analyses are employed to test their utility in screening for SPC need.

Ethics and dissemination
Our findings will be published in peer-reviewed journals and presented at national and international scientific meetings and congresses. Ethical approval was granted by the Ethics Committee of Albert-Ludwigs—University Freiburg, Germany (approval no. 20-1103).

Trial registration number
German Clinical Trials Register, DRKS00021686, registered on 17 December 2020.

Leggi
Settembre 2022

Prostate Cancer Screening at US Cancer Centers

To the Editor In a recent research letter, Dr Koh and colleagues recently reported on prostate-specific antigen (PSA) recommendations on the public websites of 607 US cancer centers. The authors reported that there were differences in screening recommendations based on age, and that discussion of shared decision-making and the potential harms of screening were not acknowledged by many centers on their websites. We have several critiques of their methods and results.

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Settembre 2022

Impact of COVID-19 pandemic on screening and diagnosis of patients with prostate cancer: a systematic review protocol

Introduction
With the exponential progress of patients with COVID-19, unexpected restrictions were directed to limit SARS-CoV-2 dissemination and imposed health-system an entire reformation to diminish transmission risk. These changes likely have caused the full range of cancer screenings and diagnosis gaps. Regardless of the recommendations, prostate cancer (PCa) screening/diagnosis programmes were momentarily postponed. Prostate-specific antigen (PSA) testing has been an inexpensive, low-invasive and relatively precise means of detection for PCa screening that would improve the uncovering of any type of PCa. Unfortunately, a decrease in PSA screening would significantly decrease PCa detection, with non-negligible growth in PCa-specific death. This review is designed to improve our understanding of the impact of the COVID-19 pandemic on the screening and diagnosis of patients with PCa.

Methods and analysis
This systematic review will be reported in accordant with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidance. A comprehensive search has been executed through five main electronic databases: PubMed/MEDLINE, Web of Science, Scopus, Embase and ProQuest until 1 March 2022. Besides, grey literature, preprint studies and references of included studies will be searched. The main keywords have been used to perform the search strategy: COVID-19, prostatic neoplasms. All the relevant studies that met the inclusion criteria will be screened, selected and then extracted data by two independent authors. The quality assessment of the included studies will be performed by the Newcastle-Ottawa Scale. In case of any disagreement between the two authors in selecting, extracting data and assessing the quality of included studies, it will be resolved via consensus and checked by the third author.

Ethics and dissemination
As this study will be a systematic review without human participants’ involvement, there will be no requirement for ethics approval. Findings will be presented at conferences and in a peer-reviewed journal.

PROSPERO registration number
CRD42021291656.

Leggi
Agosto 2022

Utility of screening for adverse childhood experiences (ACE) in children and young people attending clinical and healthcare settings: a systematic review

Objective
To examine and synthesise the literature on adverse childhood experience (ACE) screening in clinical and healthcare settings servicing children (0–11) and young people (12–25).

Design
A systematic review of literature was undertaken.

Data source
PsycInfo, Web of Science, Embase, PubMed and CINAHL were searched through June 2021. Additional searches were also undertaken.

Eligibility criteria
English language studies were included if they reported results of an ACE tool being used in a clinical or healthcare setting, participants were aged between 0 and 25 years and the ACE tool was completed by children/young people or by parents/caregivers/clinicians on behalf of the child/young person. Studies assessing clinicians’ views on ACE screening in children/young people attending health settings were also included.

Data extraction and synthesis
Two independent reviewers extracted data and assessed for risk of bias using the Mixed Methods Appraisal Tool. Results were synthesised qualitatively.

Results
Initial searches identified 5231 articles, of which 36 were included in the final review. Findings showed that the most commonly used tool for assessing ACE was the ACE questionnaire; administering ACE tools was found to be feasible and acceptable; there were limited studies looking at the utility, feasibility and acceptability of assessing for ACE in First Nations people; and while four studies provided information on actions taken following ACE screening, no follow-up data were collected to determine whether participants accessed services and/or the impact of accessing services.

Conclusion
As the evidence stands, widespread ACE screening is not recommended for routine clinical use. More research is needed on how and what specific ACE to screen for and the impact of screening on well-being.

PROSPERO registration number
University of York Centre for Reviews and Dissemination (CRD42021260420).

Leggi
Agosto 2022

Coronavirus Disease 2019 Pandemic–related Colorectal Cancer Screening Delays Impact Unscreened Older Adults the Most, But Mitigation Strategies Exist

Colorectal cancer (CRC) screening between ages 50 and 75 years is a US Preventive Services Task Force Grade A recommendation.1 The coronavirus disease 2019 (COVID-19) pandemic initially decreased CRC screening participation by as much as 82%,2 and new variants continue to disrupt preventive care. Screening colonoscopy is more vulnerable to pandemic-related delays than the fecal immunochemical test (FIT).2 We estimated the potential clinical impact of pandemic-related interruptions in CRC screening on the US population.

Leggi
Agosto 2022

Watch me grow integrated (WMG-I): protocol for a cluster randomised controlled trial of a web-based surveillance approach for developmental screening in primary care settings

Introduction
The increasing prevalence of developmental disorders in early childhood poses a significant global health burden. Early detection of developmental problems is vital to ensure timely access to early intervention, and universal developmental surveillance is recommended best practice for identifying issues. Despite this, there is currently considerable variation in developmental surveillance and screening between Australian states and territories and low rates of developmental screening uptake by parents. This study aims to evaluate an innovative web-based developmental surveillance programme and a sustainable approach to referral and care pathways, linking primary care general practice (GP) services that fall under federal policy responsibility and state government-funded child health services.

Methods and analysis
The proposed study describes a longitudinal cluster randomised controlled trial (c-RCT) comparing a ‘Watch Me Grow Integrated’ (WMG-I) approach for developmental screening, to Surveillance as Usual (SaU) in GPs. Forty practices will be recruited across New South Wales and Queensland, and randomly allocated into either the (1) WMG-I or (2) SaU group. A cohort of 2000 children will be recruited during their 18-month vaccination visit or opportunistic visit to GP. At the end of the c-RCT, a qualitative study using focus groups/interviews will evaluate parent and practitioner views of the WMG-I programme and inform national and state policy recommendations.

Ethics and dissemination
The South Western Sydney Local Health District (2020/ETH01625), UNSW Sydney (2020/ETH01625) and University of Queensland (2021/HE000667) Human Research Ethics Committees independently reviewed and approved this study. Findings will be reported to the funding bodies, study institutes and partners; families and peer-reviewed conferences/publications.

Trial registration number
ANZCTR12621000680864.

Leggi
Agosto 2022

Approaches to the development of new mental well-being screening tools for Indigenous peoples: a systematic mixed studies review protocol

Introduction
Indigenous peoples’ world views are intricately interrelated and interconnected with those of their communities and the environments where they live. Consequently, Indigenous peoples have a holistic view of their health, which contrasts with the dominant Western biomedical paradigm. However, the mental well-being of Indigenous peoples is predominately screened using tools developed using the Western paradigm that may not be culturally appropriate. The objective of this systematic mixed studies review (SMSR) is to assess the extent of the literature related to approaches used to develop new tools to screen the mental well-being of Indigenous adults.

Methods and analysis
This SMSR will be conducted in accordance with the method proposed by Pluye et al. It will include studies that describe the development of any type of tool or approach to screen for mental well-being in Indigenous adults, globally. Searches will be limited to the English language and literature published since January 2000. Databases to be searched include: CINAHL, Medline, PsycINFO, PubMed and Scopus. Only published studies will be included in the SMSR. Data that answers the research questions will be extracted from the literature and recorded on the associated data charting form. A sequential synthesis method will be used to analyse data from qualitative, quantitative and mixed-method studies. Data will be presented graphically, diagrammatically or in tabular form depending on what approach best conveys its meaning.

Ethics and dissemination
The SMSR will describe the approach to developing new tools for screening the mental well-being of Indigenous peoples across the globe. It will support researchers, clinicians and practitioners to consider both their approach to new tool development or, if they are using a previously developed tool, how reliable and valid it is for the population that they intend to use it with. Peer-reviewed publications will be used to disseminate SMSR findings.

Leggi
Agosto 2022

Diagnostic yield of screening for SARS-CoV-2 among patients admitted to hospital for alternate diagnoses: an observational cohort study

Objectives
To determine the diagnostic yield of screening patients for SARS-CoV-2 who were admitted with a diagnosis unrelated to COVID-19 and to identify risk factors for positive tests.

Design
Cohort from the Canadian COVID-19 Emergency Department Rapid Response Network registry.

Setting
30 acute care hospitals across Canada.

Participants
Patients hospitalised for non-COVID-19-related diagnoses who were tested for SARS-CoV-2 between 1 March and 29 December 2020.

Main outcome
Positive nucleic acid amplification test for SARS-CoV-2.

Outcome measure
Diagnostic yield.

Results
We enrolled 15 690 consecutive eligible adults who were admitted to hospital without clinically suspected COVID-19. Among these patients, 122 tested positive for COVID-19, resulting in a diagnostic yield of 0.8% (95% CI 0.64% to 0.92%). Factors associated with a positive test included presence of fever, being a healthcare worker, having a positive household contact or institutional exposure, and living in an area with higher 7-day average incident COVID-19 cases.

Conclusions
Universal screening of hospitalised patients for COVID-19 across two pandemic waves had a low diagnostic yield and should be informed by individual-level risk assessment in addition to regional COVID-19 prevalence.

Trial registration number
NCT04702945.

Leggi
Agosto 2022

Evaluation of the effectiveness of a South African laboratory cryptococcal antigen screening programme using a retrospective cohort and a cluster-randomised trial design

Introduction
Cryptococcal meningitis is a common fungal opportunistic infection and a leading cause of death among people with advanced HIV disease in sub-Saharan Africa. The WHO recommends cryptococcal antigen (CrAg) screening followed by pre-emptive therapy to prevent cryptococcal meningitis and death in this population. In 2016, South Africa was the first country to implement reflexive laboratory CrAg screening nationally. The Cryptococcal Antigen Screen-and-Treat National Evaluation Team (CAST-NET) aims to evaluate the effectiveness of this national screening programme to optimise health outcomes.

Methods and analysis
The CAST-NET study consists of two integrated parts: a retrospective cohort study and a cluster-randomised trial (CRT). The retrospective cohort study will determine 6-month cryptococcal meningitis-free survival among CrAg-positive patients. Secondary outcomes include the proportion of CrAg-positive results noted for action in the CrAg-positive patient chart, the proportion of CrAg-positive patients offered and accept/decline a lumbar puncture, the proportion of CrAg-positive patients prescribed antifungal therapy and the proportion of CrAg-positive patients who have antiretroviral therapy initiated or reinitiated at an appropriate time according to South African national guidelines. Cohort data will be analysed by the type of facility (ie, hospital vs primary health clinic) at which the patient was diagnosed with antigenaemia. The CRT will determine if the appointment and mentoring of a healthcare worker, or ‘crypto champion’, at intervention facilities is associated with a higher proportion of CrAg-positive persons initiating pre-emptive fluconazole therapy. Secondary outcomes will include 6-month cryptococcal meningitis-free survival and the proportion prescribed fluconazole maintenance treatment.

Ethics and dissemination
Ethics approvals were received from the University of the Witwatersrand Human Research Ethics Committee (Medical), the University of KwaZulu-Natal Biomedical Research Ethics Committee and the University of Pretoria Faculty of Health Sciences Research Ethics Committee. Study results will be disseminated to the South African Department of Health and participating facilities through peer-reviewed publications and reports.

Leggi
Agosto 2022

Online randomised factorial trial of electronic Screening and Brief Intervention for alcohol use in pregnancy: a study protocol

Introduction
Approximately 1 in 7 pregnant women in the USA report past-month alcohol use. Strong evidence connects prenatal alcohol exposure with a range of adverse perinatal outcomes, including the spectrum of conditions known as fetal alcohol spectrum disorders. Screening and Brief Intervention (SBI) has been recommended for pregnant women but has proven difficult to implement. This study will test the efficacy of single-session technology-delivered SBI (electronic SBI) for alcohol use in pregnancy, while simultaneously evaluating the possible additional benefit of tailored text messages and/or booster sessions in a 3×2 factorial trial.

Method and analysis
This full factorial trial will use online advertising and clinic-based flyers to recruit pregnant women meeting criteria for unhealthy alcohol use, and randomly assign them to one of six conditions crossing three levels of brief intervention (none, single 120-minute session and single session plus two 5-minute boosters) with two levels of tailored text messaging (none vs twice weekly messages). The primary analysis will test for dose–response effects of the brief intervention on alcohol abstinence, defined as no self-report of alcohol use in the 90 days prior to 34 weeks’ gestation, and negative results for ethyl glucuronide analysis of fingernail samples. Secondary analyses will examine main and interaction effects of tailored text messaging as well as intervention effects on birth outcomes.

Ethics and dissemination
Ethical approval was provided by the Michigan State University Biomedical and Health Institutional Review Board (STUDY00005298). Results will be presented at conferences and community forums, in addition to being published in a peer-reviewed journal. Intervention content demonstrating sufficient efficacy and safety will be made publicly available.

Trial registration number
ClinicalTrials.gov Registry (NCT04332172).

Leggi
Agosto 2022