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.

Heat waves increase the morbidity and mortality in Germany, particularly of older patients in need of care. Due to climate change the number of heat waves in Germany will increase threefold by the end of the century. In addition, the proportion of patients at risk will grow due to demographic change. Therefore, the Government and the Federal States have developed recommendations for heat action plans, in which the medical profession should also participate in the prevention of heat-related damage to health. Physicians and their team should first become acquainted with the topic. In addition, they should inform patients at risk and their relatives of the risks and preventive measures. In the summer a critical check of drugs is also needed because medications impair cooling mechanisms in heat waves, the pharmacokinetics can change and unwanted side effects of drugs occur more frequently. Lastly, due to their central position in the healthcare system, physicians should participate in the coordination of a good nursing care and intensification of social contacts during heat waves.

Data sharing is central to the rapid translation of research into advances in clinical medicine and public health practice. In the context of COVID-19, there has been a rush to share data marked by an explosion of population-specific and discipline-specific resources for collecting, curating, and disseminating participant-level data. We conducted a scoping review and cross-sectional survey to identify and describe COVID-19-related platforms and registries that harmonise and share participant-level clinical, omics (eg, genomic and metabolomic data), imaging data, and metadata. We assess how these initiatives map to the best practices for the ethical and equitable management of data and the findable, accessible, interoperable, and reusable (FAIR) principles for data resources. We review gaps and redundancies in COVID-19 data-sharing efforts and provide recommendations to build on existing synergies that align with frameworks for effective and equitable data reuse. We identified 44 COVID-19-related registries and 20 platforms from the scoping review. Data-sharing resources were concentrated in high-income countries and siloed by comorbidity, body system, and data type. Resources for harmonising and sharing clinical data were less likely to implement FAIR principles than those sharing omics or imaging data. Our findings are that more data sharing does not equate to better data sharing, and the semantic and technical interoperability of platforms and registries harmonising and sharing COVID-19-related participant-level data needs to improve to facilitate the global collaboration required to address the COVID-19 crisis.

Individual participant data meta-analyses (IPD-MAs) have several benefits over standard aggregate data meta-analyses, including the consideration of additional participants, follow-up time, and the joint consideration of study- and participant-level heterogeneity for improved diagnostic and prognostic model development and evaluation. However, IPD-MAs are resource-intensive and require careful budgeting of time from data contributing groups, a dedicated management team, diversity of expertise, clearly documented data sharing and authorship agreements, and consistent and clear communication. We present a toolkit to facilitate the implementation and management of IPD-MAs, from study recruitment to retrospective harmonization. The toolkit was developed and refined over our work on multiple multinational IPD-MA projects over the last 13 years. The toolkit's budget and email templates, agreements, project management spreadsheets, and standard operating procedures are meant to facilitate routine IPD-MA tasks to expedite implementing and managing future IPD-MA projects.

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.

Broad consent for future use facilitates the reuse of participant-level data and samples, which can conserve limited resources by confirming research findings and facilitate the development and evaluation of public health and clinical advances. Ethics review committees (ERCs) have to balance different stakeholder concerns when evaluating the risks and benefits associated with broad consent for future use. In this qualitative study, we evaluated ERC members' concerns about different aspects of broad consent, including appropriate governance, community engagement, evaluation of risks and benefits, and communication of broad consent for future use in Colombia, which does not currently have national guidance related to broad consent for future use. We conducted semi-structured, in-depth interviews with 24 ERC members from nine Colombian ERCs. We used thematic analysis to explore ERC members' concerns related to broad consent for future use. Most ERC members expressed concern about the idea of not specifying the purposes for which data would be used and by whom and suggested that pre-specifying governance procedures and structure would address some of their concerns about broad consent. ERC members emphasized the need for engaging communities and ensuring research participants understood broad consent for future use-related language in informed consent forms. Researchers and research institutions are under increasing pressure to share public health-related data. ERC members play a central role in balancing the priorities of different stakeholders and maintaining their community's trust in public health research. Further work is needed on guidelines for developing language around broad consent, evaluating community preferences related to data sharing, and developing standards for describing governance for data or sample sharing in the research protocol to address ERC members' concerns around broad consent for future use.

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.

Could primary chemoradiotherapy (pCRT) possibly be viewed as an alternative standard therapy to upfront total laryngectomy (TL)? According to the new German S3 guideline, despite higher rates of local recurrence, there would be no survival disadvantage and salvage surgery would be a curative option. In several large database studies and case series, statistically significant survival disadvantages of more than 30% between pCRT and TL have been reported for T4 laryngeal cancer. According to the literature, the success rate of salvage TL for T4 laryngeal cancer is only about 25-50%. Larynx preservation (LP) studies which could qualify the recommendation of pCRT as an alternative standard therapy to TL in T4 carcinomas should 1) evaluate T4a cancers within the T4 category; 2) perform subgroup analysis of laryngeal and hypopharyngeal cancers; 3) be sufficiently highly powered; 4) provide long-term outcomes of at least 5 years; 5) with oncological and 6) functional outcomes (duration of the need for tracheostomy and/or feeding tube dependency; necessity and success of salvage laryngectomies). 7) Specification of the criteria of the respective T4 classification (invasion through the outer cortex of the cartilage, or infiltration of which extralaryngeal structures) and 8) evaluation of pretreatment laryngeal function (at least: tracheostomy, feeding tube dependency). Collection of all the aforementioned data of T4 patients treated with pCRT in a large prospective observational cohort study in German-speaking countries is suggested. In case of rejection of TL by T4 laryngeal cancer patients, differentiation between primary spontaneous reluctance and a definitive, carefully considered decision is important. This distinction should be achieved by sensitive discussions. Not only oncological but also functional outcome probabilities should be included in the overall decision-making process.

Providing accurate, evidence-based information to women with Zika infection during pregnancy was problematic because of the high degree of uncertainty in the diagnosis of the infection and the associated risk. The 2015-17 Zika virus epidemic overwhelmingly affected women in countries with limited access to safe abortion. Understanding women's perspectives on risk communication during pregnancy in the context of an emerging pathogen can help inform risk communication in response to future outbreaks that affect fetal or child development. We conducted a cross-sectional qualitative interview study with 73 women from 7 locations in Brazil, Colombia, and Puerto Rico to understand women's experiences of Zika virus (ZIKV) test and outcome-related communication during the ZIKV pandemic. We used thematic analysis to analyze the in-depth interviews. Participants in Brazil and Colombia reported that the healthcare system's lack of preparation and organization in communicating ZIKV test results and associated adverse outcomes led to their feeling abandoned and alone in confronting the challenges of a ZIKV-affected pregnancy. In contrast, participants in Puerto Rico reported that the regular testing schedules and clear, well-planned communication between the care team and between providers and pregnant women helped them to feel they could prepare for a ZIKV-affected pregnancy. Communication of the risk associated with an emerging pathogen suspected to affect pregnancy and developmental outcomes is a fraught issue. Public health authorities and healthcare providers should work together in the interpandemic period to understand families' preferences for risk communication during pregnancy in the presence of uncertainty and develop a community-informed plan for risk communication.

BACKGROUND: Individual participant data meta-analyses (IPD-MAs), which involve harmonising and analysing participant-level data from related studies, provide several advantages over aggregate data meta-analyses, which pool study-level findings. IPD-MAs are especially important for building and evaluating diagnostic and prognostic models, making them an important tool for informing the research and public health responses to COVID-19. METHODS: We conducted a rapid systematic review of protocols and publications from planned, ongoing, or completed COVID-19-related IPD-MAs to identify areas of overlap and maximise data request and harmonisation efforts. We searched four databases using a combination of text and MeSH terms. Two independent reviewers determined eligibility at the title-abstract and full-text stages. Data were extracted by one reviewer into a pretested data extraction form and subsequently reviewed by a second reviewer. Data were analysed using a narrative synthesis approach. A formal risk of bias assessment was not conducted. RESULTS: We identified 31 COVID-19-related IPD-MAs, including five living IPD-MAs and ten IPD-MAs that limited their inference to published data (e.g., case reports). We found overlap in study designs, populations, exposures, and outcomes of interest. For example, 26 IPD-MAs included RCTs; 17 IPD-MAs were limited to hospitalised patients. Sixteen IPD-MAs focused on evaluating medical treatments, including six IPD-MAs for antivirals, four on antibodies, and two that evaluated convalescent plasma. CONCLUSIONS: Collaboration across related IPD-MAs can leverage limited resources and expertise by expediting the creation of cross-study participant-level data datasets, which can, in turn, fast-track evidence synthesis for the improved diagnosis and treatment of COVID-19. TRIAL REGISTRATION: 10.17605/OSF.IO/93GF2.

Zusammenfassung Hintergrund Geflüchtete Menschen sind vielfältigen psychosozialen Belastungen ausgesetzt. Zur Förderung ihrer psychischen Gesundheit werden u. a. Peer-Ansätze verfolgt. Wissenschaftliche Erkenntnisse zu den Voraussetzungen einer erfolgreichen Implementierung entsprechender Ansätze für geflüchtete Menschen in Deutschland liegen bisher jedoch kaum vor. Ziel Ziel ist es, Erkenntnisse über die Sichtweisen geflüchteter Menschen auf einen gruppenbasierten Peer-Ansatz der Psychoedukation und psychosozialen Stabilisierung („Mind-Spring“) in einem kommunalen Setting zu erlangen sowie Barrieren und fördernde Faktoren der Inanspruchnahme zu identifizieren. Methoden Nach Einführung des Ansatzes in einer Region Baden-Württembergs wurden acht leitfadengestützte Interviews mit zwei Peer-Trainern und sechs geflüchteten Menschen, die als potenzielle Teilnehmer*innen adressiert worden waren, durchgeführt. Die Interviews wurden aufgezeichnet, transkribiert und inhaltsanalytisch ausgewertet. Ergebnisse Die Teilnahme an der psychosozialen Intervention beruht auf heterogenen Bedarfen und Nutzenerwartungen. Eine aufsuchende, personalisierte Ansprache, sprachliche Verständigungsmöglichkeit und wohnortnahe Durchführung werden als fördernd erlebt. Hemmend wirken sich Faktoren wie die Sorge vor Stigmatisierung und fehlendes Vertrauen in Durchführende und andere Teilnehmende aus. Schlussfolgerung Bei der Implementierung von psychosozialen Interventionen für geflüchtete Menschen sind eine niedrigschwellige Organisation und Orientierung an den Bedarfen und Nutzenerwartungen von geflüchteten Menschen zu beachten. Die Akzeptanz wird durch ein ausgewogenes Verhältnis von Peer- und Otherness sowie die Anbindung an professionelle Versorgungsstrukturen unterstützt.

BACKGROUND: By today's standard, the optimal treatment of every individual tumor patient is discussed and determined in an interdisciplinary tumor board. According to the new S3 guidelines, larger volume T3 laryngeal cancers which are no longer safely resectable with larynx-sparing surgery are ideal candidates for a larynx preservation approach using primary chemoradiation (pCRT). So far, no clear criteria have been defined under what circumstances primary radiotherapy alone (pRT) might be acceptable in case chemotherapy (CT) is prohibited or in what cases, even in T3, upfront total laryngectomy with risk-adapted adjuvant treatment (TL±a[C]RT) should be recommended. METHOD: The literature was searched for parameters chosen as criteria for an inclusion in the surgical rather than the conservative arm in non-randomized LP studies or which proved to be significant prognostic markers after conservative treatment. Development of a counselling tool for therapeutic decision making. RESULTS: Significant prognostic markers were tumor volume (< 3.5 ccm/< 6 ccm vs. 6-12 ccm vs. > 12 ccm), presence and kind of vocal cord fixation (none vs. Succo I/II vs. Succo III/IV), extent of cartilage infiltration (none vs. minimal vs. multiple/gross), nodal status (N0‑1 vs. N2-3), and laryngeal dysfunction (pretreatment necessity of feeding tube or tracheostomy). CONCLUSION: For T3 laryngeal cancers, pRT could be acceptable when the tumor volume is < 3.5 ccm for glottic and < 6 ccm for supraglottic tumors and there are no further risk factors. pCRT can be regarded as the standard for LP for tumors between 6 ccm and 12 ccm, vocal cord fixation Succo pattern I/II, only minimal cartilage infiltration and a high nodal burden. For tumor > 12 ccm, vocal cord fixation Succo pattern III/IV, gross or multiple cartilage infiltration or clinically relevant laryngeal dysfunction, upfront TL±a[C]RT should be considered.

Zusammenfassung Medizinische Behandlung und Krankheitsprävention wirken nicht bei allen Menschen in der gleichen Weise. Personalisierte Medizin (PM) ist bestrebt, therapierelevante Unterschiede zwischen Menschen zu berücksichtigen, um beispielsweise die Wirkung von Medikamenten zu verbessern und Nebenwirkungen zu verringern. In Deutschland hat sich die Anzahl der zugelassenen medizinischen Wirkstoffe, bei denen vor Anwendung ein Test auf einen therapierelevanten Biomarker verpflichtend oder empfohlen ist, in den letzten 5 Jahren verdoppelt. Die Anwendungen von Arzneimitteln mit einem diagnostischen Begleittest werden oftmals im engeren Sinne als PM bezeichnet und liegen überwiegend im Bereich der Krebstherapie.

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.

Aktualisierungshinweis Die DDG-Praxisempfehlungen werden regelmäßig zur zweiten Jahreshälfte aktualisiert. Bitte stellen Sie sicher, dass Sie jeweils die neueste Version lesen und zitieren. Inhaltliche Neuerungen und abweichende Empfehlungen gegenüber der Vorjahresfassung Empfehlung 1: Aktualisierung der Daten zur Bevölkerungsgruppe mit Migrationshintergrund (siehe Punkt 1.3 Demographie für Deutschland). Begründung: Es gibt neuere Daten zur Demographie für Deutschland. Stützende Quellenangaben: [ 9 ] [ 11 ] Empfehlung 2: Daten aus dem Jahr 2019 zeigen, dass die Nutzung von Systemen zur konstanten Blutzuckermessung (CGM) bei Patienten ohne Migrationshintergrund 30 % häufiger ist als bei solchen mit Migrationshintergrund [ 41 ] (siehe Punkt 1.7.2 Besonderheiten in der Therapie). Begründung: Neue Erkenntnisse zur Nutzung digitaler Hilfsmittel bei der Diabetes-Therapie bzw. Blutzuckerkontrolle. Stützende Quellenangaben: [ 38 ] Empfehlung 3: Aktualisierung der Wirksamkeit gängiger Diabetes-Medikamente wie Alpha-Glukosidase-Hemmer (Acarbose) und Insulin. Begründung: Neue Erkenntnisse zur Wirksamkeit gängiger Diabetes-Medikamente bei Menschen nicht-europäischer Herkunft. Stützende Quellenangaben: [ 42 ] Empfehlung 4: Neue Daten zum ansteigenden Gebrauch von Online-Übersetzungsdiensten im Gesundheitswesen (siehe Punkt 1.8.2 Sprache) Begründung: Die Bedeutung von Online-Übersetzungsdiensten wächst auch im Gesundheitswesen und bei der Diabetes-Therapie von Menschen mit Migrationserfahrung. Empfehlung 5: Prävention des Diabetes mellitus sowie seiner Folgeerkrankungen wurden mit aufgenommen (siehe Punkt 1.11 Prävention) Begründung: Bislang wurde hauptsächlich auf die therapeutischen Ansätze und Besonderheiten des Diabetes mellitus bei Menschen mit nicht-deutscher Herkunft eingegangen. In der überarbeiteten Ausgabe werden nun auch die Prävention des Diabetes mellitus sowie seiner Folgeerkrankungen berücksichtigt. Empfehlung 6: Erweiterung und Aktualisierung des Themenkomplexes Fasten bei Menschen mit Typ-1-Diabetes (siehe Punkt 1.13 Fastenmonat Ramadan) Begründung: Neue Erkenntnisse über die Möglichkeit des Fastens bei Menschen mit Typ-1-Diabetes mellitus und unter Zuhilfenahme bestimmter Medikamentenregime. Stützende Quellenangaben: [ 93 ] [ 97 ] Die vorliegende Praxisempfehlung Diabetes und Migration der Deutschen Diabetes Gesellschaft e. V. (DDG) wurde erstmals und in Kooperation mit der Österreichischen Diabetes Gesellschaft (ÖDG) erstellt. Die Praxisempfehlung soll die bestehenden Leitlinien zum Diabetes mellitus ergänzen und stellt praktische Handlungsempfehlungen für die Diagnostik, Therapie und Betreuung von Menschen mit Diabetes mellitus, die aus anderen Sprach- und Kulturräumen stammen, zur Verfügung. Publication History Article published online: 18 October 2022 © 2022. Thieme. All rights reserved. Georg Thieme Verlag KG Rüdigerstraße 14, 70469 Stuttgart, Germany

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.

This systematic review summarizes the available evidence on the effects of mental health policies and programs on adolescent suicidal ideation, suicidal behavior, suicide, and in-person and cyberbullying victimization. We systematically searched Web of Science, Cochrane Central Register of Control Trials, Medline, and PsycINFO on 12th May 2020 and January 15, 2022 to identify relevant studies. We identified and screened 10,877 abstracts and extracted data from 22 studies. Screening and data extraction were conducted independently by two reviewers. The systematic review protocol was registered with PROSPERO (CRD42020177467) before initiating the search. Mental health programs and policies decreased the prevalence or risk for in-person and cyberbullying victimization, suicide, suicidal ideation, and suicidal behavior. No studies on the effects of mental health programs or policies on suicidal ideation, suicidal behavior, in-person and cyberbullying were conducted with adolescents in low-and-middle-income countries. Evidence from high income countries suggest that culturally appropriate mental health policies designed for youth may reduce bullying and suicidal events but youth in LMIC have been excluded from this research. Researchers should work with youth in LMIC to develop mental health policies and programs that address suicidal behavior and bullying.

To mitigate the known high transmission risk in day-care facilities for children aged 0-6 years, day-care staff were given priority for SARS-CoV-2 vaccination in Rhineland-Palatinate, Germany, in March 2021. This study assessed direct and indirect effects of early vaccination of day-care staff on SARS-CoV-2 transmission in daycares with the aim to provide a basis for the prioritisation of scarce vaccines in the future. Data came from statutory infectious disease notifications in educational institutions and from in-depth investigations by the district public health authorities. Using interrupted time series analyses, we measured the effect of mRNA-based vaccination of day-care staff on SARS-CoV-2 infections and transmission. Among 566 index cases from day-care centres, the mean number of secondary SARS-CoV-2 infections per index case dropped by -0.60 case per month after March 2021. The proportion of staff among all cases reported from daycares was around 60% in the pre-interruption phase and significantly decreased by 27 percentage points immediately in March 2021 and by further 6 percentage points each month in the post-interruption phase. Early vaccination of day-care staff reduced SARS-CoV-2 cases in the overall day-care setting and thus also protected unvaccinated children. This should inform future decisions on vaccination prioritisation.

Data sharing is central to the rapid translation of research into advances in clinical medicine and public health practice. In the context of COVID-19, there has been a rush to share data, marked by an explosion of population- and discipline-specific resources for collecting, curating, and disseminating participant-level data. We present a comprehensive overview of COVID-19-related platforms and registries that harmonize and share participant-level clinical, OMICs, and imaging data and metadata, and describe how these initiatives map to best practice for ethical, equitable, and FAIR management of data resources. Data sharing resources were concentrated in high income countries and siloed by comorbidity, body system, and data type. Resources for sharing clinical data were less FAIR than those for sharing OMICs or imaging data. We review gaps and redundancies in COVID-19 data sharing efforts and outline recommendations to build on existing synergies and align with frameworks for effective and equitable data reuse.

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.