OBJECTIVE: This study aims to (1) build and validate model-based case definitions for multiple sclerosis (MS) that use trends (ie, trend-based case definitions) and (2) to apply dynamic classification to identify the average number of data years needed for classification (ie, average trend needed).
METHODS: Retrospective cohort study design.
METHODS: 608 MS cases and 59 620 MS non-cases.
METHODS: Data from 1 April 2004 to 31 March 2022 were obtained from the Manitoba Population Research Data Repository. MS case status was ascertained from homecare records and linked to health data. Trend-based case definitions were constructed using multivariate generalised linear mixed models applied to annual numbers of general and specialist physician visits, hospitalisations and MS healthcare contacts or medication dispensations. Dynamic classification, which ascertains cases and non-cases annually, was used to estimate mean classification time. Classification accuracy performance measures, including sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), proportion correctly classified (PCC) and F1-scores, were compared for trend-based case definitions and a deterministic case definition of 3+MS healthcare contacts or medication dispensations.
RESULTS: When applied to the full study period, classification accuracy performance measure estimates for all case definitions exceeded 0.90, except sensitivity and PPV for the trend-based dynamic case definition (0.88, 0.64, respectively). PCC was high for all case definitions (0.94-0.99); F1-scores were lower for the trend-based case definitions compared with the deterministic case definition (0.74-0.93 vs 0.96). Dynamic classification identified 5 years as the average trend needed. When applied to the average trend windows, accuracy estimates for trend-based case definitions were lower than the estimates from the full study period (sensitivity: 0.77-0.89; specificity: 0.90-0.97; PPV: 0.54-0.81; NPV: 0.97-0.99; F1-score: 0.64-0.84). Accuracy estimates for the deterministic case definition remained high, except sensitivity (0.42-0.80). F1-score was variable (0.59-0.89).
CONCLUSIONS: Trend-based and deterministic case definitions classifications were similar to a population-based clinician assessment reference standard for multiple measures of classification accuracy. However, accuracy estimates for both trend-based and deterministic case definitions varied as the years of data used for classification were reduced. Dynamic classification appears to be a viable option for identifying the average trend needed for trend-based case definitions.

BACKGROUND: The commonly used frequentist paradigm of null hypothesis statistics testing with its reliance on the p-value and the corresponding notion of \'statistical significance\' has been under ongoing criticism. Misinterpretation and misuse of the p-value have contributed to publication bias, unreliable studies, frequent false positives, fraud and mistrust in results of scientific studies. While p-values themselves are still useful, part of the problem may be the confusion between statistical and clinical significance. In randomised controlled trials of health interventions, this confusion could lead to erroneous conclusions about treatment efficacy, research waste and compromised patient outcomes. The extent to which clinical and statistical significance of published randomised clinical trials do not match is not known. This is a protocol for a methodological study to understand the extent of the problem of disparities between statistical and clinical significance in published clinical trials, and to identify and assess the factors associated with discrepant results in these studies.
METHODS: A methodological survey of published randomised controlled trials is planned. Trials published between 2018 and 2022 and their protocols will be searched and screened for inclusion, with a planned sample size of 500 studies. The reported minimum clinically important difference, the study effect size and confidence intervals will be used to assess clinical importance of trial results. Comparison of statistical significance and clinical importance of the trial results will be used to determine disparity. Data will be analysed to estimate the outcomes, and factors associated with disparate study results will be assessed using logistic regression analysis.
BACKGROUND: Ethical approval for the study has been granted by Stellenbosch University\'s Health Research Ethics Committee. This is part of a larger study towards a PhD in Biostatistics and will be disseminated as a thesis, conference abstract and peer-reviewed manuscript.

BACKGROUND: In the context of iterative feedback loops to support real-time policy decision making, and an emphasis on speeding up adoption of evidence-based interventions, qualitative healthcare researchers are increasingly expected to produce rapid results and products. Traditional qualitative methods have been adapted for this purpose.
OBJECTIVE: To develop and apply a rapid analysis framework in a process evaluation for the VICTORION-Spirit study; a ground-breaking hybrid trial examining real-world delivery of inclisiran-a cholesterol-lowering treatment-in primary care.
METHODS: We developed a rapid analysis framework, using a summary template, to analyse data from semistructured telephone interviews.
METHODS: Primary care in Greater Manchester, UK.
METHODS: Patients who had received inclisiran as part of the VICTORION-Spirit trial (56), providers delivering inclisiran (28) and representatives from the Academic Health Science Network (8) participated in the original study.
RESULTS: The rapid analysis framework we developed and applied comprised six steps: (1) creating a summary template based on the five Consolidated Framework for Implementation Research domains; (2) test-driving, refining and finalising the summary template; (3) completing the template soon after each interview using field notes; (4) discussing analysis as a team; (5) transferring summaries to a matrix; and (6) using the summary matrix to inform presentations and interim reports for stakeholders. Our rapid analysis framework saved time and improved efficiency, as we were able to feedback barriers to stakeholders in real time via presentations.
CONCLUSIONS: Rapid analysis in applied healthcare research can produce timely and trustworthy findings. Our rapid analysis framework would be useful within studies where there is a need to feedback to stakeholders and adjust implementation strategies accordingly in real time. Thus, supporting successful implementation efforts and accelerating adoption.
BACKGROUND: NCT04807400, 19/03/2021.

BACKGROUND: Sociodemographic variables influence health outcomes, either directly (ie, gender identity) or indirectly (eg, structural/systemic racism based on ethnoracial group). Identification of how sociodemographic variables can impact the health of critically ill adults is important to guide care and research design for this population. However, despite the growing recognition of the importance of collecting sociodemographic measures that influence health outcomes, insufficient and inconsistent data collection of sociodemographic variables persists in critical care studies. We aim to develop a set of core data variables (CoDaV) for social determinants of health specific to studies involving critically ill adults.
METHODS: We will conduct a scoping review to generate a list of possible sociodemographic measures to be used for round 1 of the modified Delphi processes. We will engage relevant knowledge users (previous intensive care unit patients and family members, critical care researchers, critical care clinicians and research co-ordinators) to participate in the modified Delphi consensus survey to identify the CoDaV. A final consensus meeting will be held with knowledge user representatives to discuss the final CoDaV, how each sociodemographic variable will be collected (eg, level of granularity) and how to disseminate the CoDaV for use in critical care studies.
BACKGROUND: The University of Calgary conjoint health research ethics board has approved this study protocol (REB22-1648).

BACKGROUND: Reviews of commercial and publicly available smartphone (mobile) health applications (mHealth app reviews) are being undertaken and published. However, there is variation in the conduct and reporting of mHealth app reviews, with no existing reporting guidelines. Building on the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines, we aim to develop the Consensus for APP Review Reporting Items (CAPPRRI) guidance, to support the conduct and reporting of mHealth app reviews. This scoping review of published mHealth app reviews will explore their alignment, deviation, and modification to the PRISMA 2020 items for systematic reviews and identify a list of possible items to include in CAPPRRI.
METHODS: We are following the Joanna Briggs Institute approach and Arksey and O\'Malley\'s five-step process. Patient and public contributors, mHealth app review, digital health research and evidence synthesis experts, healthcare professionals and a specialist librarian gave feedback on the methods. We will search SCOPUS, CINAHL Plus, AMED, EMBASE, Medline, APA PsycINFO and the ACM Digital Library for articles reporting mHealth app reviews and use a two-step screening process to identify eligible articles. Information on whether the authors have reported, or how they have modified the PRISMA 2020 items in their reporting, will be extracted. Data extraction will also include the article characteristics, protocol and registration information, review question frameworks used, information about the search and screening process, how apps have been evaluated and evidence of stakeholder engagement. This will be analysed using a content synthesis approach and presented using descriptive statistics and summaries. This protocol is registered on OSF (https://osf.io/5ahjx).
BACKGROUND: Ethical approval is not required. The findings will be disseminated through peer-reviewed journal publications (shared on our project website and on the EQUATOR Network website where the CAPPRRI guidance has been registered as under development), conference presentations and blog and social media posts in lay language.

BACKGROUND: African cities, particularly Abidjan and Johannesburg, face challenges of rapid urban growth, informality and strained health services, compounded by increasing temperatures due to climate change. This study aims to understand the complexities of heat-related health impacts in these cities. The objectives are: (1) mapping intraurban heat risk and exposure using health, socioeconomic, climate and satellite imagery data; (2) creating a stratified heat-health forecast model to predict adverse health outcomes; and (3) establishing an early warning system for timely heatwave alerts. The ultimate goal is to foster climate-resilient African cities, protecting disproportionately affected populations from heat hazards.
METHODS: The research will acquire health-related datasets from eligible adult clinical trials or cohort studies conducted in Johannesburg and Abidjan between 2000 and 2022. Additional data will be collected, including socioeconomic, climate datasets and satellite imagery. These resources will aid in mapping heat hazards and quantifying heat-health exposure, the extent of elevated risk and morbidity. Outcomes will be determined using advanced data analysis methods, including statistical evaluation, machine learning and deep learning techniques.
BACKGROUND: The study has been approved by the Wits Human Research Ethics Committee (reference no: 220606). Data management will follow approved procedures. The results will be disseminated through workshops, community forums, conferences and publications. Data deposition and curation plans will be established in line with ethical and safety considerations.

BACKGROUND: Many patients referred for suspicion of myelodysplastic neoplasm (MDS) are subjected to unnecessary discomfort from bone marrow aspiration, due to the low disease prevalence in this population. Flow cytometric analysis of peripheral blood neutrophil myeloperoxidase expression could rule out MDS with sensitivity and negative predictive value estimates close to 100%, ultimately obviating the need for bone marrow aspiration in up to 35% of patients. However, the generalisability of these findings is uncertain due to the limited sample size, the enrolment of patients at a single study site, and the reliability issues associated with laboratory-developed tests and varying levels of operator experience. This study aims to validate the accuracy attributes of peripheral blood neutrophil myeloperoxidase expression quantified by flow cytometric analysis in an independent multicentre sample.
METHODS: The MPO-MDS-Valid project is a cross-sectional diagnostic accuracy study comparing an index test to a reference standard. Consecutive adult patients referred for suspicion of MDS are being recruited at seven university hospitals and one cancer centre in France. At each site, flow cytometric analysis of peripheral blood samples is performed by operators who are blinded to the reference diagnosis. A central adjudication committee whose members are unaware of the index test results will determine the reference diagnosis of MDS, based on cytomorphological evaluation of bone marrow performed in duplicate by experienced hematopathologists. The target sample size is 400 patients and the anticipated study recruitment completion date is 31 December 2025.
BACKGROUND: An institutional review board (Comité de Protection des Personnes Nord-Ouest III, Caen, France) approved the protocol, prior to the start of the study. Participants are recruited using an opt-out approach. Efforts will be made to publish the primary results within 6 months after study completion.
BACKGROUND: NCT05175469.

OBJECTIVE: The main aim of this study was to demonstrate how ordered network analysis of video-recorded interactions combined with verbal response mode (VRM) coding (eg, edification, disclosure, reflection and interpretation) can uncover specific communication patterns that contribute to the development of shared understanding between physicians and nurses. The major hypothesis was that dyads that reached shared understanding would exhibit different sequential relationships between VRM codes compared with dyads that did not reach shared understanding.
METHODS: Observational study design with the secondary analysis of video-recorded interactions.
METHODS: The study was conducted on two oncology units at a large Midwestern academic health care system in the USA.
METHODS: A total of 33 unique physician-nurse dyadic interactions were included in the analysis. Participants were the physicians and nurses involved in these interactions during patient care rounds.
METHODS: The primary outcome measure was the development of shared understanding between physicians and nurses, as determined by prior qualitative analysis. Secondary measures included the frequencies, orders and co-occurrences of VRM codes in the interactions.
RESULTS: A Mann-Whitney U test showed that dyads that reached shared understanding (N=6) were statistically significantly different (U=148, p=0.00, r=0.93) from dyads that did not reach shared understanding (N=25) in terms of the sequential relationships between edification and disclosure, edification and advisement, as well as edification and questioning. Dyads that reached shared understanding engaged in more edification followed by disclosure, suggesting the importance of this communication pattern for reaching shared understanding.
CONCLUSIONS: This novel methodology demonstrates a robust approach to inform interventions that enhance physician-nurse communication. Further research could explore applying this approach in other healthcare settings and contexts.

BACKGROUND: Observational studies are fraught with several biases including reverse causation and residual confounding. Overview of reviews of observational studies (ie, umbrella reviews) synthesise systematic reviews with or without meta-analyses of cross-sectional, case-control and cohort studies, and may also aid in the grading of the credibility of reported associations. The number of published umbrella reviews has been increasing. Recently, a reporting guideline for overviews of reviews of healthcare interventions (Preferred Reporting Items for Overviews of Reviews (PRIOR)) was published, but the field lacks reporting guidelines for umbrella reviews of observational studies. Our aim is to develop a reporting guideline for umbrella reviews on cross-sectional, case-control and cohort studies assessing epidemiological associations.
METHODS: We will adhere to established guidance and prepare a PRIOR extension for systematic reviews of cross-sectional, case-control and cohort studies testing epidemiological associations between an exposure and an outcome, namely Preferred Reporting Items for Umbrella Reviews of Cross-sectional, Case-control and Cohort studies (PRIUR-CCC). Step 1 will be the project launch to identify stakeholders. Step 2 will be a literature review of available guidance to conduct umbrella reviews. Step 3 will be an online Delphi study sampling 100 participants among authors and editors of umbrella reviews. Step 4 will encompass the finalisation of PRIUR-CCC statement, including a checklist, a flow diagram, explanation and elaboration document. Deliverables will be (i) identifying stakeholders to involve according to relevant expertise and end-user groups, with an equity, diversity and inclusion lens; (ii) completing a narrative review of methodological guidance on how to conduct umbrella reviews, a narrative review of methodology and reporting in published umbrella reviews and preparing an initial PRIUR-CCC checklist for Delphi study round 1; (iii) preparing a PRIUR-CCC checklist with guidance after Delphi study; (iv) publishing and disseminating PRIUR-CCC statement.
BACKGROUND: PRIUR-CCC has been approved by The Ottawa Health Science Network Research Ethics Board and has obtained consent (20220639-01H). Participants to step 3 will give informed consent. PRIUR-CCC steps will be published in a peer-reviewed journal and will guide reporting of umbrella reviews on epidemiological associations.

BACKGROUND: Due to a change in diagnostic prerequisites and the inclusion of novel diagnostic entities, the implementation of the 11th revision of the International Classification of Diseases (ICD-11) will presumably change prevalence rates of specific mental, behavioural or neurodevelopmental disorders and result in an altered prevalence rate for this grouping overall. This scoping review aims to summarise the characteristics of primary studies examining the prevalence of mental, behavioural or neurodevelopmental disorders based on ICD-11 criteria. The knowledge attained through this review will primarily characterise the methodological approaches of this research field and additionally assist in deciding which psychiatric diagnoses are-given the current literature-most relevant for subsequent systematic reviews and meta-analyses intended to approximate the magnitude of prevalence rates while providing a first glimpse of the range of expected (differences in) prevalence rates in these conditions.
METHODS: MEDLINE, Embase, Web of Science and PsycINFO will be searched from 2011 to present without any language filters. This scoping review will follow the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Review guidelines.We will consider (a) cross-sectional and longitudinal studies (b) focusing on the prevalence rates of mental, behavioural or neurodevelopmental disorders (c) using ICD-11 criteria for inclusion. The omission of (a) case numbers and sample size, (b) study period and period of data collection or (c) diagnostic procedures on full-text level is considered an exclusion criterion.This screening will be conducted by two reviewers independently from one another and a third reviewer will be consulted with disagreements. Data extraction and synthesis will focus on outlining methodological aspects.
BACKGROUND: We intend to publish our review in a scientific journal. As the primary data are publicly available, we do not require research ethics approval.