Heidelberg Institute of Global Health

OBJECTIVE: To externally validate various prognostic models and scoring rules for predicting short term mortality in patients admitted to hospital for covid-19. DESIGN: Two stage individual participant data meta-analysis. SETTING: Secondary and tertiary care. PARTICIPANTS: 46 914 patients across 18 countries, admitted to a hospital with polymerase chain reaction confirmed covid-19 from November 2019 to April 2021. DATA SOURCES: , and through PROSPERO, reference checking, and expert knowledge. MODEL SELECTION AND ELIGIBILITY CRITERIA: Prognostic models identified by the living systematic review and through contacting experts. A priori models were excluded that had a high risk of bias in the participant domain of PROBAST (prediction model study risk of bias assessment tool) or for which the applicability was deemed poor. METHODS: Eight prognostic models with diverse predictors were identified and validated. A two stage individual participant data meta-analysis was performed of the estimated model concordance (C) statistic, calibration slope, calibration-in-the-large, and observed to expected ratio (O:E) across the included clusters. MAIN OUTCOME MEASURES: 30 day mortality or in-hospital mortality. RESULTS: Datasets included 27 clusters from 18 different countries and contained data on 46 914patients. The pooled estimates ranged from 0.67 to 0.80 (C statistic), 0.22 to 1.22 (calibration slope), and 0.18 to 2.59 (O:E ratio) and were prone to substantial between study heterogeneity. The 4C Mortality Score by Knight et al (pooled C statistic 0.80, 95% confidence interval 0.75 to 0.84, 95% prediction interval 0.72 to 0.86) and clinical model by Wang et al (0.77, 0.73 to 0.80, 0.63 to 0.87) had the highest discriminative ability. On average, 29% fewer deaths were observed than predicted by the 4C Mortality Score (pooled O:E 0.71, 95% confidence interval 0.45 to 1.11, 95% prediction interval 0.21 to 2.39), 35% fewer than predicted by the Wang clinical model (0.65, 0.52 to 0.82, 0.23 to 1.89), and 4% fewer than predicted by Xie et al's model (0.96, 0.59 to 1.55, 0.21 to 4.28). CONCLUSION: The prognostic value of the included models varied greatly between the data sources. Although the Knight 4C Mortality Score and Wang clinical model appeared most promising, recalibration (intercept and slope updates) is needed before implementation in routine care.

OBJECTIVES: To support the Zika virus (ZIKV) Individual Participant Data (IPD) Consortium's efforts to harmonise and analyse IPD from ZIKV-related prospective cohort studies and surveillance-based studies of pregnant women and their infants and children; we developed and disseminated a metadata survey among ZIKV-IPD Meta-Analysis (MA) study participants to identify and provide a comprehensive overview of study-level heterogeneity in exposure, outcome and covariate ascertainment and definitions. SETTING: Cohort and surveillance studies that measured ZIKV infection during pregnancy or at birth and measured fetal, infant, or child outcomes were identified through a systematic search and consultations with ZIKV researchers and Ministries of Health from 20 countries or territories. PARTICIPANTS: Fifty-four cohort or active surveillance studies shared deidentified data for the IPD-MA and completed the metadata survey, representing 33 061 women (11 020 with ZIKV) and 18 281 children. PRIMARY AND SECONDARY OUTCOME MEASURES: Study-level heterogeneity in exposure, outcome and covariate ascertainment and definitions. RESULTS: Median study sample size was 268 (IQR=100, 698). Inclusion criteria, follow-up procedures and exposure and outcome ascertainment were highly heterogenous, differing meaningfully across regions and multisite studies. Enrolment duration and follow-up for children after birth varied before and after the declaration of the Public Health Emergency of International Concern (PHEIC) and according to the type of funding received. CONCLUSION: This work highlights the logistic and statistical challenges that must be addressed to account for the multiple sources of within-study and between-study heterogeneity when conducting IPD-MAs of data collected in the research response to emergent pathogens like ZIKV.

Arboviruses impose a major public health burden in Latin America and the Caribbean due to widespread and potentially severe infections causing microcephaly and long-lasting arthralgia. Beyond canonical vector-borne transmission, the magnitude and risk factors for transfusion-transmitted infections (TTIs) are unclear. In this narrative report, we use analyses of virological data such as infection symptomatology, viremic periods, and viral loads, to argue that dengue, Oropouche, Zika, yellow fever, and Chikungunya viruses pose an under-investigated risk of TTIs. An analysis of socioeconomic data showed that blood donation rates in Latin America and the Caribbean correlated with gross domestic product (r = 0.53, p = 0.0021) and health expenditure (r = 0.5, p = 0.0045), highlighting that resource limitations impact blood screening. Risk maps based on vector occurrence and ecological variables showed that Central America and Northwest coastal Brazil are high-risk zones, making surveillance, vector control, vaccination, and cost-effective blood screening crucial for mitigating TTIs, including Zika and potentially Oropouche viruses in pregnant women.

Broad consent for future use, wherein researchers ask participants for permission to share participant-level data and samples collected within the study for purposes loosely related to the study objectives, is central to enabling ethical data and sample reuse. Ensuring that participants understand broad consent-related language is key to maintaining trust in the study and public health research. We conducted 52 cognitive interviews to explore cohort research participants' and their parents' understanding of the broad consent-related language in the University of California at Berkeley template informed consent (IC) form for biomedical research. Participants and their parents were recruited from long-standing infectious disease cohort studies in Nicaragua and Colombia and interviewed during the COVID-19 pandemic. We conducted semi-structured interviews to assess participants' agreement with the key concepts in the IC after clarifying them through the cognitive interview. Participants did not understand abstract concepts, including collecting and reusing genetic data. Participants wanted to learn about incidental findings, future users and uses. Trust in the research team and the belief that sharing could lead to new vaccines or treatments were critical to participant support for data and sample sharing. Participants highlighted the importance of data and sample sharing for COVID-19 response and equitable access to vaccines and treatments developed through sharing. Our findings on participants' understanding of broad consent and preferences for data and sample sharing can help inform researchers and ethics review committees working to enable ethical and equitable data and sample sharing.

BACKGROUND: A shortage of midwives has been the subject of discussion in Germany in recent years. In this study, we asked midwives in Baden-Wuerttemberg about their health and professional satisfaction. METHOD: In collaboration with the Baden-Wuerttemberg Midwives Association, an online midwives survey was conducted from October 16 to December 10, 2017. Using a visual analog scale (0-100 points), the WHO-5 questionnaire (0-100 points) and the Copenhagen Burnout Inventory (0-100 points), data on health, well-being and burnout were collected. Job satisfaction was assessed on a 7-point Likert scale. Seven hundred and twenty-two midwives participated in the survey. For this study, 545 to 608 data sets were analyzed. RESULTS: Of the studied midwives, 78.1% rated their health as good or very good (≥60 points). No statistically significant difference was observed between freelance midwives, employed midwives, and midwives who worked in both occupation forms (P=0.12). Midwives who were exclusively (15.0%) or partially (12.6%) employed were more likely to have very low well-being (≤25 points) than freelance midwives (7.3%; P=0.023). In addition, midwives who were exclusively (41.5%) or partially (39.4%) employed were more likely to have a moderate or high risk of burnout (≥50 points) than freelance midwives (20.6%; P<0.001). A lower health rating, lower well-being or higher burnout risk were associated with higher professional dissatisfaction in one or more domains. In multivariable analyses, higher burnout risk in particular was associated with higher job dissatisfaction in various domains. CONCLUSIONS: A large proportion of midwives in our study showed symptoms of depression and/or burnout. On average, the health status of midwives seems to be above the health status of women from the general population in Germany, but the well-being of midwives below. We recommend further investigation of how the stress of midwives can be reduced in the course of advancing midwifery and obstetric care structures.

Introduction: The benefits of sharing participant-level data, including clinical or epidemiological data, genomic data, high-dimensional imaging data, or human-derived samples, from biomedical studies have been widely touted and may be taken for granted. As investments in data sharing and reuse efforts continue to grow, understanding the cost and positive and negative effects of data sharing for research participants, the general public, individual researchers, research and development, clinical practice, and public health is of growing importance. In this scoping review, we will identify and summarize existing evidence on the positive and negative impacts and costs of data sharing and how they are measured. Methods and analysis: Eligible studies will report on qualitative or quantitative approaches for measuring the cost of data sharing or its impact on participant privacy, individual or public health, researcher's careers, clinical or public health practice, or research or development. The systematic search strategy uses MeSH and text terms and is tailored for Ovid Medline, Cumulative Index to Nursing and Allied Health Literature, and Web of Science. We will apply the Arskey and O'Malley scoping review methodology. We selected a scoping rather than a systematic review approach to address multiple related questions and provide guidance related to an emerging field. Two reviewers will conduct the title-abstract and full-text screening and data charting independently. Discrepancies will be resolved through consensus and results will be summarized in a narrative form. Conclusion: Research participants, investigators, regulatory groups, ethics review committees, data protection officers, and funders cannot make informed decisions or policies about data reuse without appropriate means of measuring the effects, positive or negative, and cost of data sharing.

Zusammenfassung Hintergrund Im Rahmen der Tuberkulosekontrolle und der End-TB-Strategie der WHO werden in Deutschland Kontaktpersonen von Tuberkulosepatienten auf eine mögliche latente Tuberkulose-Infektion (LTBI) untersucht. Die Aktivierung einer LTBI trägt einen erheblichen Anteil der neugemeldeten Tuberkulose-Fälle in Niedrig-Inzidenz-Ländern wie Deutschland bei. Deshalb ist es ein Ziel, Fälle von LTBI zu entdecken und durch chemopräventive Behandlung zukünftige, postprimäre, aktive Tuberkulosen zu verhindern. In Deutschland wird die Rate von LTBI unter Kontaktpersonen von an Tuberkulose Erkrankten nicht systematisch erfasst. Ziel der vorliegenden Arbeit ist es, diese Datenlücke für die Stadt Köln zu schließen. Die TB-Inzidenz in Köln betrug in den letzten Jahren ca. 9/100 000 Einwohner. Im Weiteren werden Risikofaktoren für eine LTBI beschrieben und die geltenden Einschlusskriterien für die Umgebungsuntersuchung bei Tuberkulose unter Routinebedingungen in Deutschland reevaluiert. Material und Methoden Die retrospektive Kohortenstudie untersucht für die Periode 07/2012 bis 12/2016 die Rate an LTBI-Diagnosen unter Kontaktpersonen von an Lungentuberkulose erkrankten Personen im Zuständigkeitsbereich des Kölner Gesundheitsamtes sowie Faktoren, die das LTBI-Infektionsrisiko von Kontaktpersonen erhöhen. Im Rahmen der Studie wurden die Risikofaktoren Geschlecht, Alter, Art der Exposition (häusliches Umfeld/Arbeitsplatz) sowie die Kontagiosität des Indexpatienten auf ihren Einfluss auf das Infektionsrisiko bei latenter Tuberkulose berücksichtigt. Die Diagnose der latenten Tuberkulose wurde bei einem positiven Interferon-gamma Release Assay und fehlenden Zeichen einer aktiven Tuberkulose gestellt. In die Untersuchung wurden Kontaktpersonen eingeschlossen, die kumulativ eine zuvor definierte Mindestgesamtkontaktzeit zu einem Tuberkulosepatienten hatten, zum Untersuchungszeitpunkt mindestens 5 Jahre alt und in Köln gemeldet waren. Die statistische Auswertung erfolgte deskriptiv als absolute und relative Häufigkeit bei einem Signifikanzniveau von p ≤ 0,05. Die analytische Auswertung wurde mit univariater und multivariater logistischer Regression durchgeführt. Die Variablen, die sich in der Deskription als signifikant herausgestellt hatten, wurden zunächst univariat auf einen signifikanten Einfluss geprüft und bei statistisch signifikantem Ergebnis in das multivariate Modell eingeschlossen. Ergebnisse Von insgesamt 3862 IGRA-Untersuchungen unter Kontaktpersonen erfüllten 2834 Fälle die Einschlusskriterien. Im Median wurden 7 Kontaktpersonen pro Indexpatient gemeldet. 12,5 % des Untersuchungskollektives wurden positiv auf LTBI getestet. Bei Kontaktpersonen mikroskopisch offener Indexpatienten lag die Positivitätsrate bei 11,4 %, bei kulturell offenem, aber mikroskopisch negativem Indexpatient bei 14,3 %. Außerdem konnte gezeigt werden, dass das männliche Geschlecht (OR = 1,95), Alter ≥ 50 Jahre (OR = 1,8) und die Exposition im Haushalt (OR = 2,37) das LTBI-Infektionsrisiko erhöhten. Schlussfolgerung Unter Anwendung der DZK-Kriterien lag die Positivitätsrate der IGRA-Testung und die Diagnosestellung LTBI unter Kontaktpersonen in der vorliegenden Untersuchung mit 12,5 % niedriger als in anderen ähnlichen Studien. Die in der Kohorte identifizierten Faktoren für ein erhöhtes Risiko einer LTBI bestätigen bekannte Konstellationen. Die signifikant höhere Positivitätsrate unter Kontaktpersonen mikroskopisch negativer, aber kulturell positiver Indexpatienten (p = 0,033) unterstreicht die Notwendigkeit, auch in dieser Gruppe eine ausführliche Kontaktuntersuchung durchzuführen.

OBJECTIVES: Enabling the reuse of participant-level health data is central to advancing public health and clinical practice. Measuring knowledge, attitudes and practices (KAP) related to data sharing is essential for understanding how stakeholders perceive data reuse and where further investment is needed. We conducted a measurement systematic review to identify and describe the development, scope and measurement properties of quantitative surveys assessing data-sharing-related KAP in biomedical research. DESIGN: Systematic review using the COnsensus-based Standards for the selection of health status Measurement INstruments (COSMIN) approach. DATA SOURCES: Ovid (MEDLINE), EMBASE, CINAHL, PsycINFO and HaPI were searched for relevant surveys from 1 January 2000 to 7 April 2021. The Ovid (MEDLINE) search was updated on 30 May 2022 and 15 April 2024. ELIGIBILITY CRITERIA: Quantitative surveys measuring knowledge, attitudes, behaviours or practices related to sharing or reusing participant-level health data were included. DATA EXTRACTION AND SYNTHESIS: Two independent reviewers screened studies, extracted data and, where possible, applied the COSMIN Risk of Bias checklist to assess survey measurement properties. We summarised survey scope, target populations, data types, development and measurement properties narratively. Due to substantial heterogeneity, survey findings were not compared across studies. RESULTS: We screened 3684 title-abstracts, reviewed 104 full texts and extracted data from 72 publications representing 60 independent surveys. Most surveys originated from high-income countries and were used only once. Fewer than one-third reported pilot testing. Only six surveys provided sufficient information to apply COSMIN, and only three reported measurement properties, indicating low certainty in the available evidence. CONCLUSIONS: This is the first systematic comparison of the development and measurement properties of quantitative survey instruments assessing data-reuse KAP. Most surveys lacked rigorous development and reporting, limiting their utility for comparing KAP related to data sharing across stakeholders and settings. The review findings will inform the creation of a cross-country, cross-disciplinary question bank to support future tool development. PROSPERO REGISTRATION NUMBER: CRD42021243926.

Abstract Violence against women and girls (VAWG) is a serious human rights violation that has intensified in Yemen due to war, displacement, and pandemics. The cultural stigma surrounding discussions of VAWG, particularly sexual violence, compounded by a lack of resources for affected individuals, poses significant challenges for research and program implementation. This study involved qualitative interviews with 20 community midwives from the National Yemeni Midwifery Association across four governorates to explore the causes, forms, and consequences of VAWG and identify potential resources for survivors. A Yemeni physician trained in ethical VAWG research conducted the interviews, which were analysed thematically by two researchers. The findings indicated that physical partner violence was widely recognised as a crime; however, women and girls facing sexual violence often faced severe social ramifications, including ostracism or violence aimed at preserving family honour, leading to underreporting. Midwives identified patriarchal culture and the ongoing economic crisis as key contributors to VAWG. Health-related consequences for survivors included physical injuries such as vaginal tears and obstetric fistula. Additionally, midwives reported that survivors encountered humiliation within the healthcare system. Most women and girls did not seek help; however, when they did, they turned to their families or local leaders for support. To effectively understand, prevent, and address VAWG in Yemen, strategies should prioritise the safety and needs of women and align with cultural values. Insights from community midwives can guide the development of VAWG-focused community-led initiatives.