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Drug Discovery Today Oct 2023The European Medicines Agency (EMA) and FDA have policy goals of strengthening benefit-risk (B-R) capabilities; but how this has been translating into regulatory... (Review)
Review
The European Medicines Agency (EMA) and FDA have policy goals of strengthening benefit-risk (B-R) capabilities; but how this has been translating into regulatory practice is unclear. A systematic review of oncology drug approvals between 2015 and 2020 was conducted with approvals identified through review of FDA and EMA annual reports, with extraction of information on submission, clinical program and B-R assessment from publicly available review documents. Data were extracted from 236 reviews (EMA: 66 new submissions, 100 label extensions; FDA: 70 new submissions). The standard of evidence for B-R assessments seems to have diversified over time; yet, despite policy targets to extend their use, these assessments rarely include patient experience or real-world data.
Topics: United States; Humans; United States Food and Drug Administration; Medical Oncology; Drug Approval
PubMed: 37467877
DOI: 10.1016/j.drudis.2023.103719 -
Bioscience Jan 2024In this article, we present results from a literature review of intrinsic, instrumental, and relational values of nature conducted for the Intergovernmental... (Review)
Review
In this article, we present results from a literature review of intrinsic, instrumental, and relational values of nature conducted for the Intergovernmental Science-Policy Platform on Biodiversity and Ecosystem Services, as part of the . We identify the most frequently recurring meanings in the heterogeneous use of different value types and their association with worldviews and other key concepts. From frequent uses, we determine a core meaning for each value type, which is sufficiently inclusive to serve as an umbrella over different understandings in the literature and specific enough to help highlight its difference from the other types of values. Finally, we discuss convergences, overlapping areas, and fuzzy boundaries between different value types to facilitate dialogue, reduce misunderstandings, and improve the methods for valuation of nature's contributions to people, including ecosystem services, to inform policy and direct future research.
PubMed: 38313563
DOI: 10.1093/biosci/biad109 -
Health Promotion and Chronic Disease... Mar 2024The COVID-19 pandemic exacerbated health inequities worldwide. Research conducted in Canada shows that Black populations were disproportionately exposed to COVID-19 and... (Review)
Review
INTRODUCTION
The COVID-19 pandemic exacerbated health inequities worldwide. Research conducted in Canada shows that Black populations were disproportionately exposed to COVID-19 and more likely than other ethnoracial groups to be infected and hospitalized. This scoping review sought to map out the nature and extent of current research on COVID-19 among Black people in Canada.
METHODS
Following a five-stage methodological framework for conducting scoping reviews, studies exploring the effects of the COVID-19 pandemic on Black people in Canada, published up to May 2023, were retrieved through a systematic search of seven databases. Of 457 identified records, 124 duplicates and 279 additional records were excluded after title and abstract screening. Of the remaining 54 articles, 39 were excluded after full-text screening; 2 articles were manually picked from the reference lists of the included articles. In total, 17 articles were included in this review.
RESULTS
Our review found higher rates of COVID-19 infections and lower rates of COVID-19 screening and vaccine uptake among Black Canadians due to pre-COVID-19 experiences of institutional and structural racism, health inequities and a mistrust of health care professionals that further impeded access to health care. Misinformation about COVID-19 exacerbated mental health issues among Black Canadians.
CONCLUSIONS
Our findings suggest the need to address social inequities experienced by Black Canadians, particularly those related to unequal access to employment and health care. Collecting race-based data on COVID-19 could inform policy formulation to address racial discrimination in access to health care, quality housing and employment, resolve inequities and improve the health and well-being of Black people in Canada.
Topics: Humans; Black People; Canada; COVID-19; North American People; Pandemics
PubMed: 38501682
DOI: 10.24095/hpcdp.44.3.05 -
Frontiers in Digital Health 2023This review focuses on studies about digital health interventions in sub-Saharan Africa. Digital health interventions in sub-Saharan Africa are increasingly adopting... (Review)
Review
BACKGROUND
This review focuses on studies about digital health interventions in sub-Saharan Africa. Digital health interventions in sub-Saharan Africa are increasingly adopting gender-transformative approaches to address factors that derail women's access to maternal healthcare services. However, there remains a paucity of synthesized evidence on gender-transformative digital health programs for maternal healthcare and the corresponding research, program and policy implications. Therefore, this systematic review aims to synthesize evidence of approaches to transformative gender integration in digital health programs (specifically mHealth) for maternal health in sub-Saharan Africa.
METHOD
The following key terms "mobile health", "gender", "maternal health", "sub-Saharan Africa" were used to conduct electronic searches in the following databases: PsycInfo, EMBASE, Medline (OVID), CINAHL, and Global Health databases. The method and results are reported as consistent with PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses). Data synthesis followed a convergent approach for mixed-method systematic review recommended by the JBI (Joanna Briggs Institute).
RESULTS
Of the 394 studies retrieved from the databases, 11 were included in the review. Out of these, six studies were qualitative in nature, three were randomized control trials, and two were mixed-method studies. Findings show that gender transformative programs addressed one or more of the following categories: (1) gender norms/roles/relations, (2) women's specific needs, (3) causes of gender-based health inequities, (4) ways to transform harmful gender norms, (5) promoting gender equality, (6) progressive changes in power relationships between women and men. The most common mHealth delivery system was text messages via short message service on mobile phones. The majority of mHealth programs for maternal healthcare were focused on reducing unintended pregnancies through the promotion of contraceptive use. The most employed gender transformative approach was a focus on women's specific needs.
CONCLUSION
Findings from gender transformative mHealth programs indicate positive results overall. Those reporting negative results indicated the need for a more explicit focus on gender in mHealth programs. Highlighting gender transformative approaches adds to discussions on how best to promote mHealth for maternal health through a gender transformative lens and provides evidence relevant to policy and research.
SYSTEMATIC REVIEW REGISTRATION
PROSPERO CRD42023346631.
PubMed: 38026837
DOI: 10.3389/fdgth.2023.1263488 -
American Journal of Preventive Medicine Feb 2024Many nonregulatory interventions targeting children and youth have been implemented at three levels: directed at the individual (e.g., interactive video games),... (Review)
Review
INTRODUCTION
Many nonregulatory interventions targeting children and youth have been implemented at three levels: directed at the individual (e.g., interactive video games), delivered to students at school (e.g., campus bans), and launched in the community (e.g., mass media campaigns). This systematic review aims to synthesize the evidence on the effectiveness of interventions aimed at preventing e-cigarette initiation among children and youth.
METHODS
MEDLINE, CINAHL, Embase, APA PsycINFO, and Web of Science Core Collection were searched for papers published between January 1, 2004 and September 1, 2022 that reported more than one outcome on vaping prevention among individuals aged less than 21-years-old: vaping prevalence/incidence, initiation intentions, knowledge/attitudes, and other tobacco product use prevalence/initiation intentions. Interventions were at the individual, school, or community level. The risk of bias was assessed using ROBINS-I and RoB 1.
RESULTS
Thirty-nine publications met the eligibility criteria. Fourteen individually-based (4 parental monitoring, 3 video games, 2 text messages, 3 graphic message themes, 2 healthcare), 19 school-based (14 educational and skill interventions, 5 vape-free policies/bans), and 6 community-based (3 social media, 3 mass media campaigns) interventions were reported. E-cigarette initiation prevention was observed with high perceived parental monitoring; however, the cross-sectional study designs precluded causal claims. There was promising but limited evidence that social-emotional skills curricula and peer leader programming prevented vaping initiation.
DISCUSSION
Some individual- and school-based interventions showed promise for preventing e-cigarette initiation among children and youth.
Topics: Adolescent; Child; Humans; Young Adult; Cross-Sectional Studies; Electronic Nicotine Delivery Systems; Smoking Prevention; Students; Vaping
PubMed: 37802308
DOI: 10.1016/j.amepre.2023.09.028 -
PharmacoEconomics Dec 2023Missing data in costs and/or health outcomes and in confounding variables can create bias in the inference of health economics and outcomes research studies, which in...
BACKGROUND
Missing data in costs and/or health outcomes and in confounding variables can create bias in the inference of health economics and outcomes research studies, which in turn can lead to inappropriate policies. Most of the literature focuses on handling missing data in randomized controlled trials, which are not necessarily always the data used in health economics and outcomes research.
OBJECTIVES
We aimed to provide an overview on missing data issues and how to address incomplete data and report the findings of a systematic literature review of methods used to deal with missing data in health economics and outcomes research studies that focused on cost, utility, and patient-reported outcomes.
METHODS
A systematic search of papers published in English language until the end of the year 2020 was carried out in PubMed. Studies using statistical methods to handle missing data for analyses of cost, utility, or patient-reported outcome data were included, as were reviews and guidance papers on handling missing data for those outcomes. The data extraction was conducted with a focus on the context of the study, the type of missing data, and the methods used to tackle missing data.
RESULTS
From 1433 identified records, 40 papers were included. Thirteen studies were economic evaluations. Thirty studies used multiple imputation with 17 studies using multiple imputation by chained equation, while 15 studies used a complete-case analysis. Seventeen studies addressed missing cost data and 23 studies dealt with missing outcome data. Eleven studies reported a single method while 20 studies used multiple methods to address missing data.
CONCLUSIONS
Several health economics and outcomes research studies did not offer a justification of their approach of handling missing data and some used only a single method without a sensitivity analysis. This systematic literature review highlights the importance of considering the missingness mechanism and including sensitivity analyses when planning, analyzing, and reporting health economics and outcomes research studies.
Topics: Humans; Data Interpretation, Statistical; Bias; Research Design; Cost-Benefit Analysis; Outcome Assessment, Health Care
PubMed: 37490207
DOI: 10.1007/s40273-023-01297-0 -
Public Health Nov 2023The aim of this study was to systematically evaluate the current economic burden of coronary heart disease (CHD) in mainland China and provide a reference for the... (Review)
Review
OBJECTIVES
The aim of this study was to systematically evaluate the current economic burden of coronary heart disease (CHD) in mainland China and provide a reference for the formulation of policies to reduce the economic burden of CHD.
STUDY DESIGN
A systematic literature review was conducted of empirical studies on the economic burden of CHD over the past 20 years.
METHODS
PubMed, Web of Science, Embase, China Knowledge Resource Integrated Database and the WANFANG database were comprehensively searched for relevant articles published between 1 January 2000 and 22 December 2021. Content analysis was used to extract the data, and Stata 17.0 software was used for analysis. The median values were used to describe trends.
RESULTS
A total of 35 studies were included in this review. The annual median per-capita hospitalisation expense and the average expense per hospitalisation were $3544.40 ($891.64-$18,371.46) and $5407.34 ($1139.93-$8277.55), respectively. The median ratio on medical consumables expenses, drug expenses, medical examination expenses and treatment expenses were 41.59% (12.40%-63.73%), 26.90% (7.30%-60.00%), 9.45% (1.65%-33.40%) and 10.10% (2.36%-66.00%), respectively. The median per-capita hospitalisation expense in the eastern, central and western regions were $9374.45 ($2056.13-$18,371.46), $4751.5 ($2951.95-$8768.93) and $3251.25 ($891.64-$13,986.38), respectively. The median average expense per hospitalisation in the eastern and central regions were $6177.15 ($1679.15-$8277.55) and $1285.49 ($1239.93-$2197.36), respectively. The median average length of stay in the eastern, central and western regions were 9.3 days, 15.2 days and 16.1 days, respectively.
CONCLUSIONS
The economic burden of CHD is more severe in mainland China than in developed countries, especially in terms of the direct economic burden. In terms of the types of direct medical expenses, a proportion of medical examination expenses, treatment expenses and drug expenses were lowest in the eastern region, but medical consumables expenses were the highest in this region. This study provides guidance for the formulation of policies to reduce the economic burden of CHD in mainland China.
Topics: Humans; China; Coronary Disease; Cost of Illness; Hospitalization; Health Care Costs
PubMed: 37797560
DOI: 10.1016/j.puhe.2023.08.034 -
Reviews on Environmental Health Mar 2024Lead in the environment remains a matter of grave concern for public health. Lead has been associated with some traditional medicines and has been linked to cases of... (Review)
Review
Lead in the environment remains a matter of grave concern for public health. Lead has been associated with some traditional medicines and has been linked to cases of lead poisoning. A comprehensive compilation of these reports has not previously been conducted. The objective of this review is to explore how common is lead exposure after traditional medicine use, and which countries, systems and/or products are of most concern when it comes to lead contamination. A systematic search was conducted on PubMed, Ovid and EMBASE for studies published between 2005 and 2020. A grey literature search was conducted. Search terms related to lead and traditional medicine were developed for each database, and there were no limitations on language. Studies were included if they examined elevated lead in humans resulting from the use of traditional medicines reported in case reports, case-series, or observational studies. Of the papers discussing lead exposure, 85 case reports were identified and synthesized for the current review. Several themes were identified in the included studies. Traditional medicine has been used in the many parts of the world, however use is more common in South and Southeast Asian countries. The level of detectable lead in products varied widely by region and product types. Consumers of traditional medicines sought products for a wide variety of symptoms and ailments. The symptoms of lead poisoning from traditional medicine use reflected the typical symptom profile of lead poisoning, highlighting the need for awareness of traditional medicine products as a source of lead exposure. Traditional medicine usage remains an important part of health care in many regions, however there is a risk of lead exposure from several products. Health care practitioners in all regions of the world should be aware of the risk and explore the potential for traditional medicine use for patients presenting with elevated blood lead levels. Countries with a strong traditional medicine culture should explore policies for reducing lead exposure from traditional medicine products. JG, LO and MNBD are staff members of the World Health Organization. The authors alone are responsible for the views expressed in this publication and they do not necessarily represent the decisions, policy, or views of the World Health Organization.
Topics: Humans; Asia; Databases, Factual; Lead; Lead Poisoning; Medicine, Traditional
PubMed: 36322973
DOI: 10.1515/reveh-2022-0079 -
Journal of Medical Internet Research Aug 2023Telehealth interventions have become increasingly important in health care provision, particularly during the COVID-19 pandemic. Video calls have emerged as a popular... (Review)
Review
BACKGROUND
Telehealth interventions have become increasingly important in health care provision, particularly during the COVID-19 pandemic. Video calls have emerged as a popular and effective method for delivering telehealth services; however, barriers limit the adoption among allied health professionals and nurses.
OBJECTIVE
This review aimed to identify and map the perceived barriers to the use of video call-based telehealth interventions among allied health professionals and nurses.
METHODS
A comprehensive literature search was conducted in the PubMed and CINAHL databases on June 22, 2022, and updated on January 3, 2023, following the PRISMA-ScR (Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews) guidelines. Only original studies published in English or German since June 2017 that reported barriers to the use of video call-based telehealth interventions were eligible for inclusion. The studies had to involve interviews, focus groups, or questionnaires with physical therapists, occupational therapists, speech and language therapists, audiologists, orthoptists, dieticians, midwives, or nurses. Each publication was coded for basic characteristics, including country, health profession, and target group. Inductive coding was used to identify the patterns, themes, and categories in the data. Individual codings were analyzed and summarized narratively, with similarities and differences in barriers identified across health professions and target groups.
RESULTS
A total of 56 publications were included in the review, with barriers identified and categorized into 8 main categories and 23 subcategories. The studies were conducted in various countries, predominantly the United States, Australia, the United Kingdom, Canada, Israel, and India. Questionnaires were the most commonly used evaluation method, with 10,245 health professionals involved. Interviews or focus groups were conducted with 288 health professionals. Most of the included publications focused on specific health care professions, with the highest number addressing barriers for physical therapists, speech and language therapists, and audiologists. The barriers were related to technology issues, practice issues, patient issues, environmental issues, attributions, interpersonal issues, policies and regulations, and administration issues. The most reported barriers included the lack of hands-on experience, unreliable network connection, the lack of technology access, diminished fidelity of observations and poor conditions for visual instructions, the lack of technology skills, and diminished client-practitioner interaction and communication.
CONCLUSIONS
This review identified key barriers to video call-based telehealth use by allied health professionals and nurses, which can foster the development of stable infrastructure, education, training, guidelines, policies, and support systems to improve telehealth services. Further research is necessary to identify potential solutions to the identified barriers.
Topics: Humans; Pandemics; COVID-19; Telemedicine; Australia; Health Personnel
PubMed: 37526957
DOI: 10.2196/46715 -
EClinicalMedicine Oct 2023Migration health research pays little attention to the places into which people migrate. Studies on health effects of contextual factors are often limited because of the...
BACKGROUND
Migration health research pays little attention to the places into which people migrate. Studies on health effects of contextual factors are often limited because of the ability of individuals to self-select their environment, but natural experiments may allow for the causal effect of contexts to be examined. The objective was to synthesise the evidence on contextual health effects from natural experiments among migrant groups.
METHODS
We performed a systematic review of natural experiments among migrant populations in PubMed/MEDLINE, The Cochrane Library, Web of Science, CINAHL and Google Scholar for literature published until 13 October 2022. 5870 articles were screened in duplicate using the following inclusion criteria: quantitative natural experiment design, migrant population, context factor as treatment variable and health or healthcare outcome variable. Synthesis without meta-analysis was performed following quality appraisal using the EPHPP tool for quantitative studies and data extraction (PROSPERO: CRD42020169236).
FINDINGS
The 46 included articles provide evidence for negative effects of neighbourhood disadvantage on physical health and mortality, while finding mixed effects on mental health. Articles comparing migrants with those that stayed behind demonstrate detrimental effects of migration and adverse post-migratory contexts on physical health and mortality, while demonstrating favourable effects for mental and child health. Natural experiments of policy environments indicate the negative impacts of restrictive migration and social policies on healthcare utilization, mental health and mortality, as well as the positive health effects when restrictions are lifted.
INTERPRETATION
Natural experiments complement observational studies and provide robust evidence to advocate for more inclusive migration, health and social policies as well as neighbourhood improvement programmes. In order to strengthen the methodological approach, future research utilising natural experiments should be more explicit in the mechanisms underlying the experiment and provide details on potential causal mechanisms for the observed effects.
FUNDING
German Science Foundation (FOR: 2928/GZ: BO5233/1-1).
PubMed: 37936656
DOI: 10.1016/j.eclinm.2023.102206