UNASSIGNED: While longitudinal designs can provide significant advantages compared to single measurement/cross sectional designs, they require careful attention to study infrastructure and the risk of attrition among the sample over multiple time points.
UNASSIGNED: The strategies used to design and manage an appropriate infrastructure for a longitudinal study and approaches to retain samples are explored using examples from 2 studies, a 25-year study of persons living with multiple sclerosis and a 10-year longitudinal follow-up of breast cancer survivors.
UNASSIGNED: Key strategies (developing appropriate infrastructure, minimizing costs to participants, and maximizing rewards of study participation) have helped address the serious threat of attrition in these longitudinal samples.
UNASSIGNED: Implementation of these strategies can help mitigate some of the disadvantages and leverage the strengths of longitudinal research to produce reliable, insightful, and impactful outcomes.

BACKGROUND: Women with previous pregnancy-related cardiovascular risk indicators, including gestational diabetes mellitus (GDM) and hypertensive disorders of pregnancy (HDP), have an increased risk of future cardiovascular disease (CVD). Although CVD screening and preventive care beginning in the early postpartum period are recommended, certain barriers limit access to such services. We plan to conduct a scoping review of the literature to explore and summarise evidence on the barriers and facilitators of postpartum CVD preventive services in women with a history of GDM and HDP.
METHODS: This scoping review will be conducted in line with the Arksey and O\'Malley\'s (2005) methodological framework and the Joanna Briggs Institute guidance for conducting a systematic scoping review and will follow the Evidence for Policy and Practice Information and the Coordinating Centre at the Institute of Education guidelines. The review results will be reported using the Preferred Reporting Items for Systematic reviews and Meta-Analyses extension for Scoping Reviews (PRISMA-ScR) checklist. We will search the following databases: Medline, Embase and CINAHL. We will conduct grey literature searches for registered dissertations and theses. Inclusion and exclusion criteria will be kept broad. Qualitative and quantitative studies published in English or French that investigated and reported percieved barriers or facilitators to postpartum CVD screening and preventive care among women with previous GDM and HDP will be included. Individual, interpersonal, organizational, and system level factors will be reported. Qualitative findings will be summarised narratively, and quantitative findings will be absorbed within the themes using the multisource synthesis method.
BACKGROUND: This review represents one objective of a larger project that was reviewed by the Ottawa Health Sciences Network Research Ethics Board (QI-184). We will disseminate knowledge emanating from this review through open-access publication, presentation/public forums on women\'s cardiovascular health, women\'s CVD prevention forums and social media. We will also present the findings of this review at the annual meeting of the Canadian Women\'s Heart Health Alliance.

BACKGROUND: Ensuring patient safety in radiation oncology is crucial for delivering high-quality healthcare. Patient safety indicators (PSIs) provide a mechanism for identifying, quantifying and evaluating risks and the effectiveness of safety measures. However, there is currently no specialised set of PSIs tailored for radiation oncology in Germany. This study seeks to: (1) create PSIs specifically designed for radiation oncology settings, (2) develop and psychometrically validate an instrument for assessing safety in German radiation oncology facilities and (3) evaluate the feasibility of implementing this instrument in routine clinical practice. The finalised questionnaire will serve as a self-assessment instrument for radiation oncology departments, aiding them in evaluating their efficacy in ensuring patient safety, prioritising safety interventions and tracking performance over time.
METHODS: We are undertaking a 3-year, mixed methods study to address our objectives. For the identification of PSIs, we will conduct a comprehensive review on the PubMed database, along with reviewing national and international guidelines and recommendations. To refine the initial set of indicators, we will consult with experts, including physicians, medical physicists, nurses, administrators and radiation therapists through focus groups. We will employ a Delphi study for the final consensus and selection of indicators. Additionally, the perspectives of patients will be incorporated by formation of a project patient\'s committee which meets throughout the project phases. We will reformulate the identified PSIs into questionnaire items. The questionnaire\'s clarity and comprehensibility will be validated through cognitive interviews, followed by psychometric testing in a pilot group of over 150 participants from German radiation oncology departments. The final version of the questionnaire will then be implemented in routine healthcare settings and we will interview individual users about their experiences with the questionnaire in semistructured interviews. We will convene a subsequent expert workshop to discuss the study results and explore avenues for the questionnaire\'s broader implementation. The finalised questionnaire will be made accessible via a web app. We hereby present the study potocol as a pre-results report.
BACKGROUND: Ethical approval for this study was granted by the Hamburg Ethics Committee (Approval Number: 2023-101018-BO-ff). This trial is registered by the ARO (Arbeitsgemeinschaft Radioonkologie /working group for radiation oncology of the German Cancer Society), protocol number 2023-03 and in the German register for clinical trials with the number DRKS00034690. Study results will be published in conference papers and talks as well as journal papers with focus on open access journals. The results will be also disseminated during the implementation workshop in phase III, which will involve a diverse group of stakeholders.
BACKGROUND: DRKS00034690.

BACKGROUND: Due to the COVID-19 outbreak, schools had to switch online. As universities ease face-to-face (F2F) schooling, blended teaching and learning (BTL) enables the continuous delivery of education. However, the sudden transition to BTL poses challenges for students and teachers, especially for health sciences programmes that require hands-on practical experience. Several studies have evaluated F2F teaching and learning contexts through student feedback and evaluations. However, there needs to be more reliable and valid self-report questionnaires that focus on the perceptions and experiences of students experiencing BTL. This study will critically appraise, compare and summarise the quality of self-report questionnaires evaluating BTL among health science university students based on their psychometric properties.
METHODS: A systematic review and meta-analysis design will be used. This review will adhere to the Preferred Reporting Items for Systematic Reviews and Meta-Analysis Protocols and follow the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) standardised guidelines. 13 databases will be searched for studies reporting BTL self-report questionnaires as evaluation tools with their respective psychometric properties. Two independent reviewers will appraise the paper using the COSMIN risk of bias checklist and the quality of evidence of the psychometric properties of the relevant questionnaires will be assessed using the modified Grading of Recommendations Assessment, Development and Evaluation approach. Based on their psychometric properties, these assessments will comprehensively summarise and present the best recommendations for the most appropriate self-report questionnaires for BTL evaluation.
BACKGROUND: The University of the Philippines\' Research Grants Administration Office exempted this research protocol from ethics review evaluation (protocol number UPMREB 2022-0259-EX) since this study will not collect individual data. The research protocol was registered with PROSPERO. The results will be disseminated through peer-reviewed journals and conferences to aid researchers and professionals in the field of health education to prudently choose effective self-report questionnaires evaluating blended learning.CRD42022372362.

BACKGROUND: Avoiding patient-prosthesis mismatch (PPM) in patients with small aortic annulus (SAA) during aortic valve replacement (AVR) is still a challenging surgical problem. Among surgical options available, aortic root enlargement (ARE) and stentless valve implantation (SVI) are the two most commonly used strategies. This systematic review will be conducted searching for superiority evidence based on comparative studies between these two options.
METHODS: This systematic review will include all relevant articles published from 1 January 1946 to 31 March 2024, with available full texts from Medline (Ovid), Embase, Cochrane Library and Web of Science databases, without any language restriction. Observational studies and randomised controlled trials comparing surgical results of ARE versus SVI for AVR in patients with small aortic root will be screened. Studies will be classified into three groups: group 1 for studies that reported SVI or other tissue valve outcomes without comparing them with ARE outcomes; group 2 for studies that reported ARE outcomes without comparing them with SVI outcomes; and group 3 for studies that compared ARE outcomes with SVI outcomes. The quality of the evidence of each study will be evaluated according to Oxford Centre for Evidence-Based Medicine criteria.
BACKGROUND: Ethical approval is not required because no primary data are collected. The findings will be presented at scientific conferences and/or reported in a peer-reviewed scientific journal.
BACKGROUND: PROSPERO, CRD42023383793.

BACKGROUND: The early detection of pancreatic cancer is an important step in reducing mortality by offering patients curative treatment. Screening strategies in risk populations and by means of different detection methods have been economically evaluated. However, a synthesis of screening studies to inform resource allocation towards early detection within the disease area has not been done. Therefore, studies evaluating the cost-effectiveness and costs of screening for pancreatic cancer should be systematically reviewed.
METHODS: A systematic review of economic evaluations reporting the cost-effectiveness or costs of pancreatic cancer screening will be conducted. The electronic databases Medline, Web of Science and EconLit will be searched without geographical or time restrictions. Two independent reviewers will select eligible studies based on predefined criteria. The study quality will be assessed using the Consolidated Health Economic Evaluation Reporting Standards statement and the Bias in Economic Evaluation checklist. One reviewer will extract relevant data and a second reviewer will cross-check compliance with the extraction sheet. Key items will include characteristics of screened individuals, the screening strategies used, and costs, health effects and cost-effectiveness as study outputs. Differences of opinion between the reviewers will be solved by consulting a third reviewer.
BACKGROUND: Ethics approval is not required for this study since no original data will be collected. The results will be disseminated through presentations at conferences and publication in a peer-reviewed journal. The results of the systematic review will inform future economic evaluations of pancreatic screening, which provide guidance for decision-making in healthcare resource prioritisation.
UNASSIGNED: CRD42023475348.

BACKGROUND: Autistic young people and/or those with attention deficit hyperactivity disorder (ADHD) who have co-occurring mental health conditions experience significant challenges when transitioning from child and adolescent mental health services (CAMHS) to adult mental health services (AMHS). However, barriers and facilitators to this service transition are poorly understood for this population. This scoping review aims to synthesise the available evidence on barriers and enablers to the transition from CAMHS to AMHS for autistic young people and/or those with ADHD.
METHODS: Arksey and O\'Malley\'s six-step framework for scoping reviews will be used. The Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews checklist will guide the reporting of this review. Electronic databases of Medline, PsycINFO, CINAHL, Scopus, ProQuest Central and Google Scholar will be searched for relevant articles published in English with no date limitations. Title, abstract and full-text screening will be completed by two independent reviewers. Studies will be eligible for inclusion if the article focuses on (1) adolescents and/or young people (aged 18-24) with a primary diagnosis of autism spectrum disorder and/or ADHD (population) and (2) describes factors associated with service or care transitions (concept) (3) from CAMHS to AMHS (context). Study quality will be evaluated using the Standard Quality Assessment Criteria for Evaluating Primary Research Papers from a Variety of Fields. Data describing the factors that enable or inhibit the transition from CAMHS to AMHS will be extracted and synthesised using the Bronfenbrenner\'s social ecological model as a framework for organising and reporting results.
BACKGROUND: Ethics approval is not required. Findings will be disseminated via peer-reviewed publications and presented at conferences.
BACKGROUND: https://doi.org/10.17605/OSF.IO/BZPQF.

There are good practical reasons to use electronic consent (e-consent) in randomised trials, especially when conducting large-scale clinical trials to answer population-level health research questions. However, determining ethical reasons for e-consent is not so clear and depends on a proper understanding of what e-consent means when used in clinical trials and its ethical significance. Here we focus on four features of ethical significance which give rise to a range of ethical considerations relating to e-consent and merit further focused ethics research.

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Critical care trials evaluate the effect of interventions in patients with diverse personal histories and causes of illness, often under the umbrella of heterogeneous clinical syndromes, such as sepsis or acute respiratory distress syndrome. Given this variation, it is reasonable to expect that the effect of treatment on outcomes may differ for individuals with variable characteristics. However, in randomized controlled trials, efficacy is typically assessed by the average treatment effect (ATE), which quantifies the average effect of the intervention on the outcome in the study population. Importantly, the ATE may hide variations of the treatment\'s effect on a clinical outcome across levels of patient characteristics, which may erroneously lead to the conclusion that an intervention does not work overall when it may in fact benefit certain patients. In this review, we describe methodological approaches for assessing heterogeneity of treatment effect (HTE), including expert-derived subgrouping, data-driven subgrouping, baseline risk modeling, treatment effect modeling, and individual treatment rule estimation. Next, we outline how insights from HTE analyses can be incorporated into the design of clinical trials. Finally, we propose a research agenda for advancing the field and bringing HTE approaches to the bedside.