Project description:Many life-saving drugs are still inaccessible and unaffordable in low- and middle-income countries, particularly in Sub-Saharan Africa. This contributes to poor health outcomes, wider health and socioeconomic inequities, and higher patient spending on healthcare. While resource limitations facing national regulatory authorities (NRAs) contribute to the problem, we believe that (1) fragmented and complex drug regulations, (2) suboptimal enforcement of existing regulations, and (3) poorly designed disincentives for non-compliance play a larger role. These "unintended consequences" that are a direct result of our current regulatory regimes limit competition, keep drug costs high, and lead to shortages and the proliferation of illegitimate and unregistered drugs. While NRAs can gain a lot from increased investment in their work, regulatory harmonization and innovation can arrest and reverse the regulatory failures we still see today and improve medicine access in Africa. Unfortunately, harmonization initiatives in Sub-Saharan Africa have made modest impact and have done so slowly. We encourage greater attention and investment in harmonization and other downstream functions of NRAs. We also urge increased participation of national governments-particularly executive agencies in health and the treasury-and patient advocacy groups in advancing harmonization across the subcontinent.
Project description:BackgroundConsensus definitions for the diagnosis of invasive fungal diseases (IFDs) were updated in 2020 to increase the certainty of IFD for inclusion in clinical trials, for instance by increasing biomarker cutoff limits to define positivity. To date, there is a paucity of data as to the impact of the revised definitions on clinical trials.MethodsIn this study, we sought to determine the impact of the new definitions on classifying invasive aspergillosis (IA), the most common invasive mold disease in immunocompromised patients. We reclassified 226 proven and probable IA cases plus 139 possible IFD cases in the Aspergillus Technology Consortium (AsTeC) and in an antifungal prophylaxis trial (BMT CTN 0101) using the new criteria.ResultsFewer cases met the more stringent diagnostic 2020 criteria after applying the reclassification criteria to define probable IA. Of 188 evaluable probable cases, 41 (22%) were reclassified to 40 possible IA and 1 probable IFD. Reclassification to possible IFD occurred in 22% of hematologic malignancy (HM) patients, 29% of hematopoietic cell transplant (HCT) patients, and in no lung transplant (LT) patients. Date of diagnosis was established a median (range) of 3 (1-105) days later in 15% of probable IA cases using the new criteria. Applying the new definitions to the BMT CTN 0101 trial, the power to detect the same odds ratio decreased substantially.ConclusionsThe updated IA consensus definitions may impact future trial designs, especially for antifungal prophylaxis studies.
Project description:BRAC, an international development organization, implemented a home-fortification programme from 2014 to 2018 in Bangladesh. This study aimed to understand the unintended consequences of programmatic changes that occurred during the implementation of the programme on the prevalence of good infant and young child feeding (IYCF) practices and other associated factors. We used pooled data from eight cross-sectional surveys and data from a series of qualitative investigations carried out as part of a mixed-methods evaluation approach. A total of 6,479 caregivers of children aged 6 to 23 months participated in the surveys. The prevalence of good IYCF practices increased from baseline (42.1%) to midline (45.3%), but it decreased at the endline survey (31.9%). Qualitative investigations identified several reasons for low IYCF practices at the programme level, such as the withdrawal of community health worker (CHW) incentives for promoting IYCF, providing incentives for the home-fortification of micronutrient powder (MNP) and changing the focus from IYCF promotion to MNP promotion. A multivariable generalized estimating equation model for pooled data revealed that caregivers were 28% (adjusted risk ratio [ARR]: 0.72, 95% CI [0.67, 0.78]) less likely to maintain good IYCF practices during the period when CHWs were not incentivized to promote IYCF compared to the period when CHWs were incentivized to promote it. The prevalence of good IYCF practices decreased from both baseline and midline to the endline survey due to the unintended consequences of the programmatic changes. An integrated intervention strategy to promote the home-fortification of MNP and IYCF could be helpful to avoid unintended negative consequences of programmatic changes.
Project description:The dominant model of journal evaluation emerged at the time when there were no open-access journals, and nobody has assessed yet whether this model is able to cope with this modern reality. This commentary attempts to fill the gaps in the common understanding of the role that 'impact factor' should play in evaluation of open-access journals.
Project description:CytoJournal organized its first Peer-Reviewer's Retreat of 2006 during the United States and Canadian Academy of Pathology Annual Meeting at Atlanta on Feb 12, 2006. The major topics discussed were open access, peer review, and impact factors. Representative participants volunteered to join the task force to prepare an instructional guide for peer-reviewing cytopathology manuscripts. Concern about the impact factor for CytoJournal was discussed. A feedback to its readers and authors was recommended. Impact factor calculation needs at least three years of journal statistics. It is only possible after two years from the time a journal is first accepted by Thomson-ISI for citation tracking. CytoJournal is still too new for an impact factor to be calculated. However, general progress of CytoJournal suggests an encouraging pattern for high impact factor.
Project description:Since the early 2000s, China has carried out extensive "grain-for-green" and grazing exclusion practices to combat desertification in the desertification-prone region (DPR). However, the environmental and socioeconomic impacts of these practices remain unclear. We quantify and compare the changes in fractional vegetation cover (FVC) with economic and population data in the DPR before and after the implementation of these environmental programmes. Here we show that climatic change and CO2 fertilization are relatively strong drivers of vegetation rehabilitation from 2001-2020 in the DPR, and the declines in the direct incomes of farmers and herders caused by ecological practices exceed the subsidies provided by governments. To minimize economic hardship, enhance food security, and improve the returns on policy investments in the DPR, China needs to adapt its environmental programmes to address the potential impacts of future climate change and create positive synergies to combat desertification and improve the economy in this region.
Project description:Background Citations of papers are positively influenced by the journal's impact factor (IF). For non-open access (non-OA) journals, this influence may be due to the fact that high-IF journals are more often purchased by libraries, and are therefore more often available to researchers, than low-IF journals. This positive influence has not, however, been shown specifically for papers published in open access (OA) journals, which are universally accessible, and do not need library purchase. It is therefore important to ascertain if the IF influences citations in OA journals too. Methods 203 randomized controlled trials (102 OA and 101 non-OA) published in January 2011 were included in the study. Five-year citations for papers published in OA journals were compared to those for non-OA journals. Source papers were derived from PubMed. Citations were retrieved from Web of Science, Scopus, and Google Scholar databases. The Thompson-Reuter's IF was used. Results OA journals were found to have significantly more citations overall compared to non-OA journals (median 15.5 vs 12, p=0.039). The IF did not correlate with citations for OA journals (Spearman's rho =0.187, p=0.60). The increase in the citations with increasing IF was minimal for OA journals (beta coefficient = 3.346, 95% CI -0.464, 7.156, p=0.084). In contrast, the IF did show moderate correlation with citations for articles published in non-OA journals (Spearman's rho=0.514, p<0.001). The increase in the number of citations was also significant (beta coefficient = 4.347, 95% CI 2.42, 6.274, p<0.001). Conclusion It is better to publish in an OA journal for more citations. It may not be worth paying high publishing fees for higher IF journals, because there is minimal gain in terms of increased number of citations. On the other hand, if one wishes to publish in a non-OA journal, it is better to choose one with a high IF.
Project description:Consumers are shifting towards plant-based diets, driven by both environmental and health reasons. This has led to the development of new plant-based meat alternatives (PBMAs) that are marketed as being sustainable and good for health. However, it remains unclear whether these novel PBMAs to replace animal foods carry the same established nutritional benefits as traditional plant-based diets based on pulses, legumes and vegetables. We modelled a reference omnivore diet using NHANES 2017-2018 data and compared it to diets that substituted animal products in the reference diet with either traditional or novel plant-based foods to create flexitarian, vegetarian and vegan diets matched for calories and macronutrients. With the exception of the traditional vegan diet, all diets with traditional plant-based substitutes met daily requirements for calcium, potassium, magnesium, phosphorus, zinc, iron and Vitamin B12 and were lower in saturated fat, sodium and sugar than the reference diet. Diets based on novel plant-based substitutes were below daily requirements for calcium, potassium, magnesium, zinc and Vitamin B12 and exceeded the reference diet for saturated fat, sodium and sugar. Much of the recent focus has been on protein quality and quantity, but our case study highlights the risk of unintentionally increasing undesirable nutrients while reducing the overall nutrient density of the diet when less healthy plant-based substitutes are selected. Opportunities exist for PBMA producers to enhance the nutrient profile and diversify the format of future plant-based foods that are marketed as healthy, sustainable alternatives to animal-based products.
Project description:Prior to 2010, Medicare payments for consultations (commonly billed by specialists) were substantially higher than for office visits of similar complexity (commonly billed by primary care physicians). In January 2010, Medicare eliminated consultation payments from the Part B Physician Fee Schedule and increased fees for office visits. This change was intended to be budget neutral and to decrease payments to specialists while increasing payments to primary care physicians. We assessed the impact of this policy on spending, volume, and complexity for outpatient office encounters in 2010.We examined outpatient claims from 2007 through 2010 for 2 247 810 Medicare beneficiaries with Medicare Supplemental (Medigap) coverage through large employers in the Thomson Reuters MarketScan Database. We used segmented regression analysis to study changes in spending, volume, and complexity of office encounters adjusted for age, sex, health status, secular trends, seasonality, and hospital referral region."New" office visits largely replaced consultations in 2010. An average of $10.20 more was spent per beneficiary per quarter on physician encounters after the policy (6.5% increase). The total volume of physician encounters did not change significantly. The increase in spending was largely explained by higher office-visit fees from the policy and a shift toward higher-complexity visits to both specialists and primary care physicians.The elimination of consultations led to a net increase in spending on visits to both primary care physicians and specialists. Higher prices, partially owing to the subjectivity of codes in the physician fee schedule, explained the spending increase, rather than higher volumes.
Project description:BackgroundThe Open Biomedical Ontologies (OBO) Foundry is a collection of freely available ontologically structured controlled vocabularies in the biomedical domain. Most of them are disseminated via both the OBO Flatfile Format and the semantic web format Web Ontology Language (OWL), which draws upon formal logic. Based on the interpretations underlying OWL description logics (OWL-DL) semantics, we scrutinize the OWL-DL releases of OBO ontologies to assess whether their logical axioms correspond to the meaning intended by their authors.ResultsWe analyzed ontologies and ontology cross products available via the OBO Foundry site http://www.obofoundry.org for existential restrictions (someValuesFrom), from which we examined a random sample of 2,836 clauses.According to a rating done by four experts, 23% of all existential restrictions in OBO Foundry candidate ontologies are suspicious (Cohens' ? = 0.78). We found a smaller proportion of existential restrictions in OBO Foundry cross products are suspicious, but in this case an accurate quantitative judgment is not possible due to a low inter-rater agreement (? = 0.07). We identified several typical modeling problems, for which satisfactory ontology design patterns based on OWL-DL were proposed. We further describe several usability issues with OBO ontologies, including the lack of ontological commitment for several common terms, and the proliferation of domain-specific relations.ConclusionsThe current OWL releases of OBO Foundry (and Foundry candidate) ontologies contain numerous assertions which do not properly describe the underlying biological reality, or are ambiguous and difficult to interpret. The solution is a better anchoring in upper ontologies and a restriction to relatively few, well defined relation types with given domain and range constraints.