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.

OBJECTIVE: Understanding flexibility and adaptive capacities in complex healthcare systems is a cornerstone of resilient healthcare. Health systems provide structures in the form of standards, rules and regulation to healthcare providers in defined settings such as hospitals. There is little knowledge of how hospital teams are affected by the rules and regulations imposed by multiple governmental bodies, and how health system factors influence adaptive capacity in hospital teams. The aim of this study is to explore the extent to which health system factors enable or constrain adaptive capacity in hospital teams.
METHODS: A qualitative multiple case study using observation and semistructured interviews was conducted between November 2020 and June 2021. Data were analysed through qualitative content analysis with a combined inductive and deductive approach.
METHODS: Two hospitals situated in the same health region in Norway.
METHODS: Members from 8 different hospital teams were observed during their workday (115 hours) and were subsequently interviewed about their work (n=30). The teams were categorised as structural, hybrid, coordinating and responsive teams.
RESULTS: Two main health system factors were found to enable adaptive capacity in the teams: (1) organisation according to regulatory requirements to ensure adaptive capacity, and (2) negotiation of various resources provided by the governing authorities to ensure adaptive capacity. Our results show that aligning to local context of these health system factors affected the team\'s adaptive capacity.
CONCLUSIONS: Health system factors should create conditions for careful and safe care to emerge and provide conditions that allow for teams to develop both their professional expertise and systems and guidelines that are robust yet sufficiently flexible to fit their everyday work context.

BACKGROUND: The aim of this methodological review is to evaluate the completeness of reporting of surgical pilot and feasibility randomised trials as per the Consolidated Standards of Reporting Trials (CONSORT) extension to randomised pilot and feasibility trials. Moreover, we aim to assess for the presence of spin reporting and inconsistency between abstract and main text reporting in surgical pilot and feasibility randomised trials.
METHODS: A comprehensive, electronic search strategy will be used to identify studies indexed in Medline, Embase and Cochrane Central Register of Controlled Trials (CENTRAL) databases. Studies will be included if they are pilot or feasibility randomised trials of surgical interventions. The primary outcome will be overall CONSORT statement extension to randomised pilot and feasibility trials checklist completeness. This will be defined as trials reporting each of the 40 items in the CONSORT statement extension to randomised pilot and feasibility trials checklist. Secondary outcomes will include the reporting of individual studies as per the CONSORT extension to randomised pilot and feasibility trials, the use of spin reporting strategies, trial factors associated with reporting quality and spin strategy use, and consistency between abstract and main text reporting. Poisson and logistic regressions will be performed to explore the association between trial factors and completeness of reporting as measured by the number of reported CONSORT items.
BACKGROUND: This is a methodological survey that has been registered a priori on the International Prospective Register for Systematic Reviews (PROSPERO) (CRD42023475512). Local ethics approval is not required. We plan to disseminate study results through peer-reviewed publication and conference presentations.

OBJECTIVE: Homecare is a critical component of the ongoing restructuring of healthcare worldwide, given the shift from institution- to home-based care. The homecare evidence base still contains significant gaps: There is a lack of knowledge regarding quality and safety work and interventions. This study explores how home healthcare professionals perceive and use the concept of risk to guide them in providing high-quality healthcare while maintaining resilience.
METHODS: The study design is a qualitative multiple case study. The phenomena explored were risk perception, sensemaking and adaptations of care delivered to patients in their homes. Inductive content analysis was conducted.
METHODS: The study was conducted in three Norwegian municipalities. Each municipality was defined as a single case.
METHODS: Interviews with healthcare professionals were performed both individually and in focus groups of three to five persons. 19 interviews with 35 informants were conducted: 11 individual semistructured interviews and 8 focus groups.
RESULTS: Four themes were identified: \'professionalism is constantly prioritising and aligning care based on here-and-now observations\' \'teamwork feels safe and enhances quality\' \'taking responsibility for system risk\' and \'reluctantly accepting the extended expectations from society\'.
CONCLUSIONS: To make sense of risk when aspiring for high-quality care in everyday work, the healthcare professionals in this sample mainly used their clinical gaze, gut feeling and experience to detect subtle changes in the patients\' condition. Assessing risk information, not only individually but also as a team, was reportedly crucial for high-quality care. Healthcare professionals emphasised the well-being, safety and soundness of the patients when acting on risk information. They felt obliged to act on their gut feeling, moral compass and clinical understanding of quality.

The implementation of complex interventions is considered challenging, particularly in multi-site clinical trials and dynamic clinical settings. This study protocol is part of the family intensive care units (FICUS) hybrid effectiveness-implementation study. It aims to understand the integration of a multicomponent family support intervention in the real-world context of adult intensive care units (ICUs). Specifically, the study will assess implementation processes and outcomes of the study intervention, including fidelity, and will enable explanation of the clinical effectiveness outcomes of the trial.
This mixed-methods multiple case study is guided by two implementation theories, the Normalisation Process Theory and the Consolidated Framework for Implementation Research. Participants are key clinical partners and healthcare professionals of eight ICUs allocated to the intervention group of the FICUS trial in the German-speaking part of Switzerland. Data will be collected at four timepoints over the 18-month active implementation and delivery phase using qualitative (small group interviews, observation, focus group interviews) and quantitative data collection methods (surveys, logs). Descriptive statistics and parametric and non-parametric tests will be used according to data distribution to analyse within and between cluster differences, similarities and factors associated with fidelity and the level of integration over time. Qualitative data will be analysed using a pragmatic rapid analysis approach and content analysis.
Ethics approval was obtained from the Cantonal Ethics Committee of Zurich BASEC ID 2021-02300 (8 February 2022). Study findings will provide insights into implementation and its contribution to intervention outcomes, enabling understanding of the usefulness of applied implementation strategies and highlighting main barriers that need to be addressed for scaling the intervention to other healthcare contexts. Findings will be disseminated in peer-reviewed journals and conferences.
Open science framework (OSF) https://osf.io/8t2ud Registered on 21 December 2022.

Despite the availability of effective, subsidised hepatitis B treatment, linkage to care and treatment rates remain very low globally. In Australia, specially trained primary care physicians (general practitioner, GPs) can prescribe hepatitis B treatment, however, most hepatitis B care occurs in specialist clinics. Increasing hepatitis B management by GPs in primary care clinics is essential to achieve national hepatitis B linkage to care and treatment targets by 2030.This pilot study determines the feasibility, acceptability and effectiveness of Simply B, a novel GP hepatitis B e-support package designed to increase hepatitis B management by GPs in primary care clinics.
This study will be conducted in three parts:Part A: A prospective open-label pilot intervention study, comparing the proportion of people with hepatitis B who are managed by their GP in primary care clinics before, 12 months and 24 months after implementation of the Simply B electronic hepatitis B support package.Part B: A nested qualitative health services feasibility study using semistructured interviews and thematic analysisPart C: Cost-effectiveness analysis.
This study has received ethics approval by St Vincent\'s Hospital. Data management and analysis will be centralised through the Department of Gastroenterology, St Vincent\'s Hospital.
NCT05614466.

Radiation emergencies are rare but can have minor confined effects to catastrophic consequences across the large geographical territories. Geographical disparities in the preparedness for radiation emergencies can negatively impact public-safety and delay protective actions. We examined such disparities using the global and regional radiation preparedness data from the revised annual International Health Regulations (IHR) data sets.
We used IHR State Party Annual Reporting (SPAR) tool and its associated health indicators developed to mitigate public health risk from radiation emergencies. Using the most recent (2019) SPAR database developed for radiation emergencies, along with 12 other cross-sector indicators, we examined the disparities among WHO state and region-wide capacity scores for operational preparedness.
Based on the analysis of the 2019 annual reporting data sets from 171 countries, radiation emergency was one of the top three global challenges with an average global preparedness capacity of 55%. Radiation emergency preparedness capacity scores showed highest dispersion score among all 13 capacities suggesting higher disparities for preparedness across the globe. Only 38% of the countries had advanced functional capacity with ≥80% operational readiness, with 28% countries having low to very low operational readiness. No geographical regions had ≥80% operational readiness for radiation emergencies, with 4/6 geographical regions showing limited capacity or effectiveness. Global data from 171 countries showed that the capacity to respond to radiation emergencies correlated with the capacity for chemical events with a correlation coefficient (ρ) of 0.70 (CI 0.61 to 0.77).
We found major global disparities for the operational preparedness against radiation emergencies. Collaborative approaches involving the public health officials and policymakers at the regional and state levels are needed to develop additional guidance to adapt emergency preparedness plans for radiation incidents.

Patients do not always tell the physician if they have used medicines differently from prescribed. The challenges that patients experience in medication self-management and adherence have been prioritised globally as among the most crucial factors influencing the effectiveness and safety of pharmacotherapies.
This study protocol presents a new patient-oriented method to investigate reasons for non-adherence using pharmacist-conducted medication reconciliation in a primary care clinic as data collection point. By interviewing, the pharmacist will learn how the patient has been taking the prescribed medicines and whether any non-prescription medicines and food supplements have been used for self-medication. The pharmacist will document the findings of the conversation to the electronic patient record in a structured format. The pharmacist will collect data related to the characteristics of the patients and outpatient clinics, patients\' diseases and medications, and medication discrepancies. These data will be analysed for descriptive statistics to identify (1) the number of discrepancies between the physician\'s prescription orders and the patient\'s self-reported use of the medicines, (2) what kind of discrepancies there are, (3) which are high-risk medicines in terms of non-adherence and (4) why medicines were taken differently from prescribed; based on the results, (5) a preliminary conceptual model of patient-reported reasons for non-adherence will be constructed.
NCT05167578.

Recent evidence shows that point-of-care (POC) testing is a more feasible alternative for diagnosis of COVID-19 in settings that have poor access to laboratory diagnostic services. Equitable access to POC testing can be optimised through well-established supply chain management (SCM) systems. The proposed study aims to develop a novel approach for improving SCM for COVID-19 POC diagnostic services in resource-limited settings with poor access to laboratory diagnostic services, using Mopani District in Limpopo Province, South Africa as a study setting.
This study was guided by results of the scoping review. Following the scoping review, we propose a mixed-methods study, which will be implemented in three phases. First, we will perform a geospatial analysis to investigate the spatial distribution of COVID-19 testing services. Second, we will perform an audit of POC diagnostic services including its supply chain to evaluate the effect of SCM on accessibility of COVID-19 POC diagnostic services and reveal SCM barriers and enablers of accessibility of COVID-19 POC diagnostic services. Third, we will perform a nominal group technique to collaborate with key stakeholders in co-creation of a novel approach for improving SCM systems for COVID-19 POC diagnostic services. For the geospatial analysis, we will employ the ArcGIS Software. For the analysis of quantitative and qualitative data that will be generated from the audit and nominal group discussion, we will employ Stata software and NVivo software, respectively.
This study has been ethically reviewed and approved by two institutional review boards: University of Pretoria Faculty of Health Sciences Research Ethics Committee (approval number 655/2021) and Limpopo Department of Health Research Ethics Committee (approval number LP-2021-12-007). The results of this study will be disseminated through national and international presentations and peer-reviewed publications.

Healthcare professionals (HCPs) often recommend their patients to use a specific mHealth app as part of health promotion, disease prevention and patient self-management. There has been a significant growth in the number of HCPs downloading and using mobile health (mHealth) apps. Most mHealth apps that are available in app stores employ a \'star rating\' system. This is based on user feedback on an app, but is highly subjective. Thus, the identification of quality mHealth apps which are deemed fit for purpose can be a difficult task for HCPs. Currently, there is no unified, validated standard guidelines for assessment of mHealth apps for patient safety, which can be used by HCPs. The Modified Enlight Suite (MES) is a quality assessment framework designed to provide a means for HCPs to evaluate mHealth apps before they are recommended to patients. MES was adapted from the original Enlight Suite for international use through a Delphi method, followed by preliminary validation process among a population predominantly consisting of medical students. This study aims to evaluate the applicability and validity of the MES, by HCPs, in low, middle and high income country settings.
MES will be evaluated through a mixed-method study, consisting of qualitative (focus group) and quantitative (survey instruments) research, in three target countries: Malaŵi (low income), South Africa (middle income) and Ireland (high income). The focus groups will be conducted through Microsoft Teams (Microsoft, Redmond, Washington, USA) and surveys will be conducted online using Qualtrics (Qualtrics International, Seattle, Washington, USA). Participants will be recruited through the help of national representatives in Malawi (Mzuzu University), South Africa (University of Fort Hare) and Ireland (University College Cork) by email invitation. Data analysis for the focus group will be by the means of thematic analysis. Data analysis for the survey will use descriptive statistics and use Cronbach alpha as an indicator of internal consistency of the MES. The construct validity of the mHealth app will be assessed by computing the confirmatory factor analysis using Amos.
The study has received ethical approval from the Social Research Ethics Committee (SREC) SREC/SOM/03092021/1 at University College Cork, Ireland, Malaŵi Research Ethics Committee (MREC), Malaŵi MZUNIREC/DOR/21/59 and Inter-Faculty Research Ethics Committee (IFREC) of University of Fort Hare (REC-2 70 710-028-RA). The results of the study will be disseminated through the internet, peer-reviewed journals and conference presentations.