Evaluating health claim assessment skills of parents with preschool children: A cross-sectional study using Informed Health Choices Claim Evaluation Tool.

Background: Health literacy is a global problem and is particularly relevant when making health care decisions about small children. We analysed how parents of preschool children assess health claims and explored the predictors of their assessment skill. Methods: We conducted a survey with questions from the Claim Evaluation Tools (CET) database, part of the Informed Health Choices (IHC) project, in ten paediatric primary care practices of the Split-Dalmatia County Health Center, Split, Croatia, from 1 February to 31 March 2023. Eligible participants were parents accompanying preschool-aged children for check-ups. We also collected data on parents' and children's demographic and health characteristics (including the presence of any chronic illness in the child), visits to paediatric emergency service, hospitalisations, vaccination status, the presence of chronic illness of parents or relatives, and whether parents had to made treatment decisions for themselves and/or their family member. Results: Overall, 402 parents of preschool children (median age 35 years (interquartile range (IQR) = 31.0-38.3)) had a median IHC CET test score of 10.0 (IQR = 8.0-11.0) out of 12 questions. The multiple regression analysis showed that female gender, higher level of education, being employed, and having a history of a visit to paediatric emergency service were significant predictors of the test score, explaining 21.9% of the variance. Conclusions: Parents of preschool children have a very good ability for critical assessment of health-related statements in a complex health care system and an environment of generally unsatisfactory health literacy. Further studies should explore how parents understand health claims in different geographical, socio-economic and cultural setting, and explore educational interventions to increase critical thinking abilities and informed decision-making, especially among fathers, unemployed parents and those with lower levels of education.

Diplomatic response to global health challenges in recognizing patient needs: A qualitative interview study.

Background: Global health diplomacy is the applied practice of foreign affairs to further national goals that focus on health issues requiring international cooperation and collective action. We aimed to determine how international diplomats and health policy-related professionals in the EU understand the concept of health diplomacy, which impacts both diplomatic relations as well as patients' rights. Methods: In a qualitative interview study, we used a heterogeneous stratified purposeful sampling to reach participants from different countries and different practitioners from the Pyramid of Health Diplomacy: core, multi-stakeholder, and informal. Reflexive thematic analysis was used to identify the main themes. Findings: We contacted 131 practitioners of GHD, of which 37 responded, and nine agreed to be interviewed. From 11 interview questions, four main themes emerged from the analysis of the individual interview. The participants reported limited knowledge about the definition of GHD but also that they engaged in daily activities and decisions of inter-governmental bodies. They were not aware of existing special education and training for health attachés and made suggestions for improving the field and practice of GHD. They were not fully familiar with the European Charter of Patients' Rights. There was a consensus from all participants that patient rights need to improve as a fundamental right. They stressed the fact that the hospital lockdown and the right access to healthcare were impaired during the COVID pandemic. Interpretation: The role of health diplomacy in linking public health and foreign affairs is key to respecting patients' rights. Health over other interests is becoming an increasingly critical element in foreign policy. Establishing a clear career path for health attachés is necessary to foster effective global health agreements and coordination across countries.

Ethics issues identified by applicants and ethics experts in Horizon 2020 grant proposals.

Background: We assessed the ethics review of proposals selected for funding under the Marie Sklodowska-Curie Actions (MSCA) and the European Research Council (ERC) in Horizon 2020, EU's framework programme for research and innovation, 2014-2020. Methods: We analysed anonymized datasets for 3,054 MSCA individual fellowships (IF), 417 MSCA Innovative Training Networks (ITN), and 1,465 ERC main-listed proposals with ethics conditional clearance, over four years (2016 to 2019). The datasets included the information on ethics issues identified by applicants in their proposal and ethics issues and requirements identified by ethics experts during the ethics review. Results: 42% of proposals received ethical clearance. For proposals with conditional ethics clearance (n=3546), most of the identified ethics issues by both applicants and ethics experts were in the ethics categories related to humans; protection of personal data; environment, health and safety; and non-EU countries. Ethics experts identified twice as many ethics issues compared to applicants across funding schemes, years, and from high- and low-research performing countries. ERC grants had the highest number of ethics requirements per proposal (median (Md)=8, interquartile range (IQR=4-14), compared to ITN (Md=6, IQR=3-13) and IF grants (Md=3, IQR=2-6). The majority of requirements had to be fulfilled after grant agreement: 99.4% for IF, 99.5% for ITN, and 26.0% for ERC. For 9% of the proposals, the requirements included the appointment of an independent ethics advisor and 1% of the proposals had to appoint an ethics advisory board. Conclusions: Many applicants for highly competitive H2020 funding schemes lack awareness of ethics issues raised by their proposed research. There is a need for better training of researchers at all career stages about ethics issues in research, more support to researchers from research organizations to follow the funding agencies requirements, as well as further development and harmonization of the ethics appraisal process during grant assessment.

A retrospective analysis of the peer review of more than 75,000 Marie Curie proposals between 2007 and 2018.

Most funding agencies rely on peer review to evaluate grant applications and proposals, but research into the use of this process by funding agencies has been limited. Here we explore if two changes to the organization of peer review for proposals submitted to various funding actions by the European Union has an influence on the outcome of the peer review process. Based on an analysis of more than 75,000 applications to three actions of the Marie Curie programme over a period of 12 years, we find that the changes - a reduction in the number of evaluation criteria used by reviewers and a move from in-person to virtual meetings - had little impact on the outcome of the peer review process. Our results indicate that other factors, such as the type of grant or area of research, have a larger impact on the outcome.

Effects of seniority, gender and geography on the bibliometric output and collaboration networks of European Research Council (ERC) grant recipients.

Assessing the success and performance of researchers is a difficult task, as their grant output is influenced by a series of factors, including seniority, gender and geographical location of their host institution. In order to assess the effects of these factors, we analysed the publication and citation outputs, using Scopus and Web of Science, and the collaboration networks of European Research Council (ERC) starting (junior) and advanced (senior) grantees. For this study, we used a cohort of 355 grantees from the Life Sciences domain of years 2007-09. While senior grantees had overall greater publication output, junior grantees had a significantly greater pre-post grant award increase in their overall number of publications and in those on which they had last authorship. The collaboration networks size and the number of sub-communities increased for all grantees, although more pronounced for juniors, as they departed from smaller and more compact pre-award co-authorship networks. Both junior and senior grantees increased the size of the community within which they were collaborating in the post-award period. Pre-post grant award performance of grantees was not related to gender, although male junior grantees had more publications than female grantees before and after the grant award. Junior grantees located in lower research-performing countries published less and had less diverse collaboration networks than their peers located in higher research-performing countries. Our study suggests that research environment has greater influence on post-grant award publications than gender especially for junior grantees. Also, collaboration networks may be a useful complement to publication and citation outputs for assessing post-grant research performance, especially for grantees who already have a high publication output and who get highly competitive grants such as those from ERC.

Effectiveness of treatment of newly diagnosed hypertension in family medicine practices in South Croatia.

BACKGROUND: Uncontrolled blood pressure remains an urgent issue in clinical practice worldwide. This study aimed to compare the characteristics and effectiveness of hypertension control in family medicine pratice in the first treatment year, in relation to the geographical position, socio-economic standard, and access to medical services and public pharmacies in urban, rural and island environments (city of Split vs. Dalmatian Hinterland vs. islands in Southern Croatia). METHODS: A historical cohort study included 213 patients diagnosed from 2008 to 2014 with essential arterial hypertension (AH) and without related complications or diabetes mellitus. Each patient was followed up for 365 days from the visit when the diagnosis of hypertension was ascertained. Normotension was defined as arterial pressure < 140/90 mmHg. The annual cost of drugs prescribed for treating newly diagnosed hypertensive patient and the total price for defined daily dose per patient were also evaluated. RESULTS: More than half patients achieved normotension within a year from the initial diagnosis in all family medicine practices (57.3%), without significant differences among the three geographic regions (P = 0.981). Higher initial systolic blood pressure was a positive predictive prognostic factor on achieveing normotension (odds ratio (OR) 0.96, 95% confidence interval 0.95-0.98). ACE inhibitors were the most commonly prescribed antihypertensive agents in monotherapy (35.1%), as well as considering overall prescriptions (25.2%). Calcium channel blockers were the most commonly prescribed initial BP-lowering single agents in urban areas (28.6%), whereas angiotensin-converting enzyme inhibitors were more common in rural (28.0%) and island areas (22.7%) (P = 0.037). The median annual antihypertensive drug cost was 169.4 (95% CI 151.5-201.8) Croatian kunas and was similar across the study sites. CONCLUSION: Multiple antihypertensive drugs, prescribed in accordance with the guidelines, lead to similar pharmacological effects. Primary care physicians seem to be able to overcome potential interfering socio-economic factors and successfully achieve normotension in newly diagnosed patients with uncomplicated AH after 1 year of treatment.

The Medical School of the Catholic University of Croatia: Principles, Goals, Standards and Organization.

The aim of the study was to present the concept on which the School of Medicine at the Catholic University of Croatia (CUC) will be established. The new School will alleviate the shortage of physicians in Croatia and introduce an innovative form of medical education focused on principles of patient-centered care and social accountability. At the same time, the students will acquire all relevant competencies and levels of knowledge, skills and attitudes that are required by current evidence in medical education, European standards and guidelines for quality assurance at higher education institutions. The four pillars of the CUC Medical School are: 1) distributed medical education that involves health institutions outside major medical centers, 2) the concept of transformative learning, 3) teaching and practicing evidence-based medicine, and 4) implementation of quality management principles supported by information technology solutions for effective management of learning, research and practice. The overall aim of the CUC School of Medicine is to educate and train physicians capable of using best available medical evidence to deliver economically sustainable healthcare that can improve equity and health outcomes in the communities they serve, particularly those that are currently underserved. CONCLUSION: The proposed programme is introducing an original system of modern medical education that insists on developing humanistic aspects of medicine, patient-centred care and social accountability, while maintaining all competencies and knowledge levels that a physician should have according to the current understanding of medical education.

Opinions and potential solutions regarding dissemination bias from funding agencies of biomedical research in Europe.

RATIONALE, AIMS, AND OBJECTIVES: Several studies have found that about half of research results from clinical trials are never published. Until now, there has been little information on the views that funding agencies of biomedical research in Europe have regarding this issue and its possible solutions. METHODS: An electronic survey was conducted among funding agencies from 34 European countries. Participants were asked about their opinions, policies, and potential solutions regarding dissemination bias. On the basis of the results of this survey and the input of the OPEN Consortium and of representatives of stakeholder groups in the knowledge generation process, we formulated recommendations for funding agencies to reduce dissemination bias. RESULTS: We received responses from 64 funding agencies of biomedical medicine from most European countries, out of 245 that were contacted (26%). Of these, 56 funded research at the national and/or international level and were therefore eligible to participate. Policies encouraging publication increased over time: 33 (58.9%) of agencies enforced them in 2005 compared to 38 (67.6%) in 2012. However, only 13 (23.2%) had knowledge of the publications related to research funded in 2005, 23 (41.1%) were able to provide only an estimate, and 20 (35.7%) did not know at all. Regarding recommendations to control dissemination bias, we propose that funding agencies request the dissemination of research results irrespective of the direction of findings. We also call for measures that allow evaluating funded projects past the contractual period and until dissemination of results. Funding agencies should create publicly accessible databases with information on funded projects and dissemination efforts. CONCLUSION: Despite having policies to encourage publication of results, most funding agencies fail to implement such measures or to ensure compliance. We propose recommendations that could be incorporated in the blueprint of calls for proposals and contracts agreed upon by funding agencies and grant recipients.

[Guidelines for Accurate and Transparent Health Estimates Reporting: the GATHER Statement]. / Diretrizes para o relato preciso e transparente de estimativas de saúde: a Declaração GATHER.

Measurements of health indicators are rarely available for every population and period of interest, and available data may not be comparable. The Guidelines for Accurate and Transparent Health Estimates Reporting (GATHER) define best reporting practices for studies that calculate health estimates for multiple populations (in time or space) using multiple information sources. Health estimates that fall within the scope of GATHER include all quantitative population-level estimates (including global, regional, national, or subnational estimates) of health indicators, including indicators of health status, incidence and prevalence of diseases, injuries, and disability and functioning; and indicators of health determinants, including health behaviours and health exposures. GATHER comprises a checklist of 18 items that are essential for best reporting practice. A more detailed explanation and elaboration document, describing the interpretation and rationale of each reporting item along with examples of good reporting, is available on the GATHER website (http://gather-statement.org).

Guidelines for Accurate and Transparent Health Estimates Reporting: the GATHER statement.

Measurements of health indicators are rarely available for every population and period of interest, and available data may not be comparable. The Guidelines for Accurate and Transparent Health Estimates Reporting (GATHER) define best reporting practices for studies that calculate health estimates for multiple populations (in time or space) using multiple information sources. Health estimates that fall within the scope of GATHER include all quantitative population-level estimates (including global, regional, national, or subnational estimates) of health indicators, including indicators of health status, incidence and prevalence of diseases, injuries, and disability and functioning; and indicators of health determinants, including health behaviours and health exposures. GATHER comprises a checklist of 18 items that are essential for best reporting practice. A more detailed explanation and elaboration document, describing the interpretation and rationale of each reporting item along with examples of good reporting, is available on the GATHER website.

Guidelines for Accurate and Transparent Health Estimates Reporting: the GATHER statement.

Gretchen Stevens and colleagues present the GATHER statement, which seeks to promote good practice in the reporting of global health estimates.

Changes to registration elements and results in a cohort of Clinicaltrials.gov trials were not reflected in published articles.

OBJECTIVES: To assess effectiveness of legislative initiatives to stimulate public registration of trial results, we assessed adherence to protocol and results reporting, changes to registry, and publication data for randomized controlled trials (RCTs) after introduction of Food and Drug Administration Amendment Act (FDAAA). STUDY DESIGN AND SETTING: Observational study of a cohort of ClinicalTrials.gov registered FDAAA-covered RCTs found through ClinicalTrials.gov between 2009 and 2012 and data from corresponding publications. WHO Minimum Data Set items were abstracted by one author and verified by the other author. RESULTS: Among 81 eligible trials, most were industry-funded, with a drug intervention in parallel assignment. Secondary outcomes at the initial and last registration were omitted for 17% and 19.7% of RCTs, respectively. RCT registration changes mostly involved scientific title (18.8%). Inclusion criteria omission was most common (88%) in publications. Inferential statistical methods for primary and secondary outcomes matched between registry and publication for 53.4% and 28.6% of RCTs, respectively. Serious and other adverse events (AEs) that were absent for 23.8% and 4.8% of RCTs, respectively, were published as nonoccurring. CONCLUSION: Discrepancies remain relatively high between registered and published outcomes, particularly regarding registered omissions in publications and concomitant reporting, nature of statistical method used, and reporting of AEs. This seriously undermines transparency of clinical trials and needs immediate attention of all stakeholders in health research.

Peer Review Evaluation Process of Marie Curie Actions under EU's Seventh Framework Programme for Research.

We analysed the peer review of grant proposals under Marie Curie Actions, a major EU research funding instrument, which involves two steps: an independent assessment (Individual Evaluation Report, IER) performed remotely by 3 raters, and a consensus opinion reached during a meeting by the same raters (Consensus Report, CR). For 24,897 proposals evaluated from 2007 to 2013, the association between average IER and CR scores was very high across different panels, grant calls and years. Median average deviation (AD) index, used as a measure of inter-rater agreement, was 5.4 points on a 0-100 scale (interquartile range 3.4-8.3), overall, demonstrating a good general agreement among raters. For proposals where one rater disagreed with the other two raters (n=1424; 5.7%), or where all 3 raters disagreed (n=2075; 8.3%), the average IER and CR scores were still highly associated. Disagreement was more frequent for proposals from Economics/Social Sciences and Humanities panels. Greater disagreement was observed for proposals with lower average IER scores. CR scores for proposals with initial disagreement were also significantly lower. Proposals with a large absolute difference between the average IER and CR scores (≥10 points; n=368, 1.5%) generally had lower CR scores. An inter-correlation matrix of individual raters' scores of evaluation criteria of proposals indicated that these scores were, in general, a reflection of raters' overall scores. Our analysis demonstrated a good internal consistency and general high agreement among raters. Consensus meetings appear to be relevant for particular panels and subsets of proposals with large differences among raters' scores.

Evidence-informed recommendations to reduce dissemination bias in clinical research: conclusions from the OPEN (Overcome failure to Publish nEgative fiNdings) project based on an international consensus meeting.

BACKGROUND: Dissemination bias in clinical research severely impedes informed decision-making not only for healthcare professionals and patients, but also for funders, research ethics committees, regulatory bodies and other stakeholder groups that make health-related decisions. Decisions based on incomplete and biased evidence cannot only harm people, but may also have huge financial implications by wasting resources on ineffective or harmful diagnostic and therapeutic measures, and unnecessary research. Owing to involvement of multiple stakeholders, it remains easy for any single group to assign responsibility for resolving the problem to others. OBJECTIVE: To develop evidence-informed general and targeted recommendations addressing the various stakeholders involved in knowledge generation and dissemination to help overcome the problem of dissemination bias on the basis of previously collated evidence. METHODS: Based on findings from systematic reviews, document analyses and surveys, we developed general and targeted draft recommendations. During a 2-day workshop in summer 2013, these draft recommendations were discussed with external experts and key stakeholders, and refined following a rigorous and transparent methodological approach. RESULTS: Four general, overarching recommendations applicable to all or most stakeholder groups were formulated, addressing (1) awareness raising, (2) implementation of targeted recommendations, (3) trial registration and results posting, and (4) systematic approaches to evidence synthesis. These general recommendations are complemented and specified by 47 targeted recommendations tailored towards funding agencies, pharmaceutical and device companies, research institutions, researchers (systematic reviewers and trialists), research ethics committees, trial registries, journal editors and publishers, regulatory agencies, benefit (health technology) assessment institutions and legislators. CONCLUSIONS: Despite various recent examples of dissemination bias and several initiatives to reduce it, the problem of dissemination bias has not been resolved. Tailored recommendations based on a comprehensive approach will hopefully help increase transparency in biomedical research by overcoming the failure to disseminate negative findings.

Analysis of evidence supporting the Federation of Bosnia and Herzegovina reimbursement medicines lists: role of the WHO Essential Medicines List, Cochrane systematic reviews and technology assessment reports.

PURPOSE: We compared recently introduced Basic Medicines Lists of the Federation of Bosnia and Herzegovina (BH) (FBH Basic Lists (FBLs)) with the World Health Organization (WHO) Essential Medicines List (EML) and the evidence supporting the inclusion of additional medicines on FBLs. METHODS: The sources of data included the 18th edition of the EML and the following FBLs: 2013 Hospital List, 2013 A List in Outpatient Setting, and 2012 List financed by the Federal Solidarity Fund. For medicines found on FBLs but not on EML, we searched the Cochrane Database of Systematic Reviews (CSR) and public health technology assessment (HTA) reports for evidence. RESULTS: FBLs had 134 medicines and 17 combinations that were not on EML, as well as 9 medicines deleted and 4 rejected from EML. EML had 82 medicines and 10 combinations of medicines not included in FBLs. Out of 125 medicines on FBLs but not on EML, 52 (42%) had good CSR evidence supporting their inclusion (n = 38) or exclusion (n = 14). For the rest (n = 74), we found 24 favourable HTA reports. For the total of 89 medicines (27%) listed on FBLs, we found no evidence (EML, CSR, HTA reports) good enough to justify their inclusion in FBLs. CONCLUSIONS: In circumstances of scarce financial resources, greater reliance on well-established, proven list is crucial. Independent, unbiased, high-quality evidence such as WHO EML, CSR and HTA reports (national or international with local adaptations) should be used when deciding on medicine reimbursement.

Using the WHO essential medicines list to assess the appropriateness of insurance coverage decisions: a case study of the Croatian national medicine reimbursement list.

PURPOSE: To investigate the use of the WHO EML as a tool with which to evaluate the evidence base for the medicines on the national insurance coverage list of the Croatian Institute of Health Insurance (CIHI). METHODS: Medicines from 9 ATC categories with highest expenditures from 2012 CIHI Basic List (n = 509) were compared with 2011 WHO EML for adults (n = 359). For medicines with specific indication listed only in CIHI Basic List we assessed whether there was evidence in Cochrane Database of Systematic Reviews questioning their efficacy and safety. RESULTS: The two lists shared 188 medicines (52.4% of WHO EML and 32.0% of CIHI list). CIHI Basic List had 254 medicines and 33 combinations of these medicines which were not on the WHO EML, plus 14 medicines rejected and 20 deleted from WHO EML by its Evaluation Committee. For deleted medicines, we could obtain data that showed 2,965,378 prescriptions issued to 617,684 insured patients, and the cost of approximately € 41.2 million for 2012 and the first half of 2013, when the CIHI Basic List was in effect. For CIHI List-only medicines with a specific indication (n = 164 or 57.1% of the analyzed set), fewer benefits or more serious side-effects than other medicines were found for 17 (10.4%) and not enough evidence for recommendations for specific indication for 21 (12.8%) medicines in Cochrane systematic reviews. CONCLUSIONS: National health care policy should use high-quality evidence in deciding on adding new medicines and reassessing those already present on national medicines lists, in order to rationalize expenditures and ensure wider and better access to medicines. The WHO EML and recommendations from its Evaluation Committee may be useful tools in this quality assurance process.

Five-step authorship framework to improve transparency in disclosing contributors to industry-sponsored clinical trial publications.

Authorship guidelines have established criteria to guide author selection based on significance of contribution and helped to define associated responsibilities and accountabilities for the published findings. However, low awareness, variable interpretation, and inconsistent application of these guidelines can lead to confusion and a lack of transparency when recognizing those who merit authorship. This article describes a research project led by the Medical Publishing Insights and Practices (MPIP) Initiative to identify current challenges when determining authorship for industry-sponsored clinical trials and develop an improved approach to facilitate decision-making when recognizing authors from related publications. A total of 498 clinical investigators, journal editors, publication professionals and medical writers were surveyed to understand better how they would adjudicate challenging, real-world authorship case scenarios, determine the perceived frequency of each scenario and rate their confidence in the responses provided. Multiple rounds of discussions about these results with journal editors, clinical investigators and industry representatives led to the development of key recommendations intended to enhance transparency when determining authorship. These included forming a representative group to establish authorship criteria early in a trial, having all trial contributors agree to these criteria and documenting trial contributions to objectively determine who warrants an invitation to participate in the manuscript development process. The resulting Five-step Authorship Framework is designed to create a more standardized approach when determining authorship for clinical trial publications. Overall, these recommendations aim to facilitate more transparent authorship decisions and help readers better assess the credibility of results and perspectives of the authors for medical research more broadly. Please see related article: http://www.biomedcentral.com/1741-7015/12/214.

Developing biobanks in developing countries.

We call for the development of human biobanks in developing countries and describe several examples from low income countries which are already building their own biobanks. Developing human biobanks in developing countries requires strengthening of the research capacity to use the new technologies, as well as a shift in research investment priorities in order to reduce the inequity in international research that currently exists. A responsible approach from low-income countries to ethical issues will be another pre-requisite to the success of the 'hypothesis-free' research that will target the needs of the world's poor.