Last data update: Jan 27, 2025. (Total: 48650 publications since 2009)
Records 1-30 (of 49 Records) |
Query Trace: Richter P[original query] |
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The American Society for Microbiology collaboration with the CDC Laboratory Medicine Best Practices initiative for evidence-based laboratory medicine
Weissfeld AS , Baselski V , Cornish NE , Kraft CS , LaRocco MT , McNult P , Nachamkin I , Parrott JS , Richter SS , Rubinstein M , Saubolle MA , Sautter RL , Snyder JW , Taliano J , Wolk DM . Clin Microbiol Rev 2024 e0006518 SUMMARYClinical medicine has embraced the use of evidence for patient treatment decisions; however, the evaluation strategy for evidence in laboratory medicine practices has lagged. It was not until the end of the 20th century that the Institute of Medicine (IOM), now the National Academy of Medicine, and the Centers for Disease Control and Prevention, Division of Laboratory Systems (CDC DLS), focused on laboratory tests and how testing processes can be designed to benefit patient care. In collaboration with CDC DLS, the American Society for Microbiology (ASM) used an evidence review method developed by the CDC DLS to develop a program for creating laboratory testing guidelines and practices. The CDC DLS method is called the Laboratory Medicine Best Practices (LMBP) initiative and uses the A-6 cycle method. Adaptations made by ASM are called Evidence-based Laboratory Medicine Practice Guidelines (EBLMPG). This review details how the ASM Systematic Review (SR) Processes were developed and executed collaboratively with CDC's DLS. The review also describes the ASM transition from LMBP to the organization's current EBLMPG, maintaining a commitment to working with agencies in the U.S. Department of Health and Human Services and other partners to ensure that EBLMPG evidence is readily understood and consistently used. |
Addressing emerging public health threats: the Noncommunicable Disease Capacity Assessment and Planning (N-CAP) Process
Saad RK , Alsouri R , Kruse MH , Kufoof L , Lobanov-Rostovsky S , Richter P , Khader Y . Front Public Health 2024 12 1384957 BACKGROUND: The global epidemic of noncommunicable diseases (NCDs) is increasing. Current assessments that monitor capacity to address NCDs are often externally led and do not facilitate country planning. The Noncommunicable Disease Capacity Assessment and Planning (N-CAP) Process assists ministries of health and other governmental and non-governmental stakeholders to assess, prioritize, and plan how to address NCDs and other public health threats. This paper describes the development of this tool. MATERIALS AND METHODS: Driven by ministries of health, the N-CAP Process engages new and existing stakeholders in three activities: Stakeholder Mapping; Strengths, Weaknesses, Opportunities, and Threats Workshop; and N-CAP Workshop that uses Discussion Guides to lead in-depth assessment and planning. Standard Operating Procedures, a library of Discussion Guides based on common NCD themes, and an open-access e-learning course are available. RESULTS: The N-CAP Process outcome is a prioritized plan of how to improve the country's public health functions. Adaptations to the tool were made after piloting in Jordan and Iraq. CONCLUSION: The N-CAP Process helps countries engage various stakeholders to identify gaps and create collaborative, country-specific strategies to effectively respond to NCDs, a leading public health threat. The pilots sparked interest from other countries and underscored its potential for broader implementation to combat the rising global burden of NCDs. |
Barriers to accessibility of medicines for hyperlipidemia in low- and middle-income countries
Li C , Spencer G , Husain MJ , Nugent R , Auzenne D , Kostova D , Richter P . PLOS Glob Public Health 2024 4 (2) e0002905 Despite the high burden of hyperlipidemia and the effectiveness of treatment, evidence suggests that the accessibility of hyperlipidemia medicines can be low in many low- and middle-income countries (LMICs). The aim of this study was to identify common barriers to the accessibility of medicines for hyperlipidemia in LMICs. A multimethod analysis and multiple data sources were used to assess the accessibility and barriers of medicines for hyperlipidemia in selected LMICs. The overall median availability of statins for hyperlipidemia in public facilities was 0% and 5.4%, for originators and generics, respectively. In private facilities, median availability was 13.3% and 35.9%, for originators and generics, respectively. Statin availability was lowest in Africa and South-East Asia. Private facilities generally had higher availability than public facilities. Statins are less affordable in lower-income countries, costing around 6 days' wages per month. Originator statins are less affordable than generics in countries of all income-levels. The median cost for statin medications per month ranges from a low of $1 in Kenya to a high of $62 in Mexico, with most countries having a median monthly cost between $3.6 and $17.0. The key informant interviews suggested that accessibility to hyperlipidemia medicines in LMICs faces barriers in multiple dimensions of health systems. The availability and affordability of statins are generally low in LMICs. Several steps could be implemented to improve the accessibility of hyperlipidemia medicines, including private sector engagement, physician education, investment in technology, and enhancement of health systems. |
Associations of diabetes, hypertension and obesity with COVID-19 mortality: a systematic review and meta-analysis
Li C , Islam N , Gutierrez JP , Gutiérrez-Barreto SE , Prado AC , Moolenaar RL , Lacey B , Richter P . BMJ Glob Health 2023 8 (12) e012581 Introduction Despite a growing body of scholarly research on the risks of severe COVID-19 associated with diabetes, hypertension and obesity, there is a need for estimating pooled risk estimates with adjustment for confounding effects. We conducted a systematic review and meta-analysis to estimate the pooled adjusted risk ratios of diabetes, hypertension and obesity on COVID-19 mortality.Methods We searched 16 literature databases for original studies published between 1 December 2019 and 31 December 2020. We used the adapted Newcastle-Ottawa Scale to assess the risk of bias. Pooled risk ratios were estimated based on the adjusted effect sizes. We applied random-effects meta-analysis to account for the uncertainty in residual heterogeneity. We used contour-funnel plots and Egger’s test to assess possible publication bias.Results We reviewed 34 830 records identified in literature search, of which 145 original studies were included in the meta-analysis. Pooled adjusted risk ratios were 1.43 (95% CI 1.32 to 1.54), 1.19 (95% CI 1.09 to 1.30) and 1.39 (95% CI 1.27 to 1.52) for diabetes, hypertension and obesity (body mass index ≥30 kg/m2) on COVID-19 mortality, respectively. The pooled adjusted risk ratios appeared to be stronger in studies conducted before April 2020, Western Pacific Region, low- and middle-income countries, and countries with low Global Health Security Index scores, when compared with their counterparts.Conclusions Diabetes, hypertension and obesity were associated with an increased risk of COVID-19 mortality independent of other known risk factors, particularly in low-resource settings. Addressing these chronic diseases could be important for global pandemic preparedness and mortality prevention.PROSPERO registration number CRD42021204371.Data are available in a public, open access repository. Not applicable. |
The HEARTS partner forum-supporting implementation of HEARTS to treat and control hypertension
Khan T , Moran AE , Perel P , Whelton PK , Brainin M , Feigin V , Kostova D , Richter P , Ordunez P , Hennis A , Lackland DT , Slama S , Pineiro D , Martins S , Williams B , Hofstra L , Garg R , Mikkelsen B . Front Public Health 2023 11 1146441 Cardiovascular diseases (CVD), principally ischemic heart disease (IHD) and stroke, are the leading causes of death (18. 6 million deaths annually) and disability (393 million disability-adjusted life-years lost annually), worldwide. High blood pressure is the most important preventable risk factor for CVD and deaths, worldwide (10.8 million deaths annually). In 2016, the World Health Organization (WHO) and the United States Centers for Disease Control (CDC) launched the Global Hearts initiative to support governments in their quest to prevent and control CVD. HEARTS is the core technical package of the initiative and takes a public health approach to treating hypertension and other CVD risk factors at the primary health care level. The HEARTS Partner Forum, led by WHO, brings together the following 11 partner organizations: American Heart Association (AHA), Center for Chronic Disease Control (CCDC), International Society of Hypertension (ISH), International Society of Nephrology (ISN), Pan American Health Organization (PAHO), Resolve to Save Lives (RTSL), US CDC, World Hypertension League (WHL), World Heart Federation (WHF) and World Stroke Organization (WSO). The partners support countries in their implementation of the HEARTS technical package in various ways, including providing technical expertise, catalytic funding, capacity building and evidence generation and dissemination. HEARTS has demonstrated the feasibility and acceptability of a public health approach, with more than seven million people already on treatment for hypertension using a simple, algorithmic HEARTS approach. Additionally, HEARTS has demonstrated the feasibility of using hypertension as a pathfinder to universal health coverage and should be a key intervention of all basic benefit packages. The partner forum continues to find ways to expand support and reinvigorate enthusiasm and attention on preventing CVD. Proposed future HEARTS Partner Forum activities are related to more concrete information sharing between partners and among countries, expanded areas of partner synergy, support for implementation, capacity building, and advocacy with country ministries of health, professional societies, academy and civil societies organizations. Advancing toward the shared goals of the HEARTS partners will require a more formal, structured approach to the forum and include goals, targets and published reports. In this way, the HEARTS Partner Forum will mirror successful global partnerships on communicable diseases and assist countries in reducing CVD mortality and achieving global sustainable development goals (SDGs). |
Advancing cardiovascular disease prevention, management, and control through field epidemiology training programs in noncommunicable diseases in low- and middle-income countries
Acharya SD , Mukhtar Q , Richter P . Prev Chronic Dis 2023 20 E31 Since 1980, the Centers for Disease Control and Prevention (CDC) has worked closely with partners worldwide to protect population health through Field Epidemiology Training Programs (FETPs). These programs are country-owned, on-the-job training programs that collaborate with local mentors and partners to focus on evidence-based best practices and research methods. The FETP goal is to build the global workforce of field epidemiologists, or “disease detectives,” and to increase their ability to detect and respond to health threats, address the severe worldwide shortage of skilled epidemiologists, and build critical relationships among partnering countries (1). The program offers 3 tiers of training, and each country can select the tier best suited to their needs: 1) FETP Frontline, which works at the local and community level; 2) FETP Intermediate, which has a regional focus; and 3) FETP Advanced, which prepares health professionals for leadership roles in ministries of health and other national-level government agencies. In all 3 tiers, 25% of training is condensed classroom instruction, and 75% is hands-on training in the field to gain experience and competence in field epidemiology (1). |
Toward a continuum of measures to mitigate primary and secondary impacts of COVID-19 and other public health emergencies
Hakim AJ , Victory KR , Summers A , Jalloh MF , Richter P , Bennett SD , Henao OL , Marston B . Popul Health Manag 2023 26 (2) 107-112 The global COVID-19 response focused heavily on nonpharmaceutical interventions (NPIs) until vaccines became available. Even where vaccination coverage is low, over time governments have become increasingly reluctant to use NPIs. Inequities in vaccine and treatment accessibility and coverage, differences in vaccine effectiveness, waning immunity, and immune-escape variants of concern of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) reinforce the long-term need for mitigation. Initially, the concept of NPIs, and mitigation more broadly, was focused on prevention of SARS-CoV-2 transmission; however, mitigation can and has done more than prevent transmission. It has been used to address the clinical dimensions of the pandemic as well. The authors propose an expanded conceptualization of mitigation that encompasses a continuum of community and clinical mitigation measures that can help reduce infection, illness, and death from COVID-19. It can further help governments balance these efforts and address the disruptions in essential health services, increased violence, adverse mental health outcomes, and orphanhood precipitated by the pandemic and by NPIs themselves. The COVID-19 pandemic response revealed the benefits of a holistic and layered mitigation approach to public health emergencies from the outset. Lessons learned can inform the next phases of the current pandemic response and planning for future public health emergencies. |
The Case for Integrating Health Systems to Manage Noncommunicable and Infectious Diseases in Low- and Middle-Income Countries: Lessons Learned From Zambia.
Richter P , Aslam M , Kostova D , Lasu AAR , Vliet GV , Courtney LP , Chisenga T . Health Secur 2022 20 (4) 286-297 Noncommunicable diseases (NCDs) are the leading cause of death in the world, and 80% of all NCD deaths occur in low- and middle-income countries (LMICs). The COVID-19 pandemic has demonstrated that patients with NCDs are at increased risk of becoming severely ill from the virus. Disproportionate investment in vertical health programs can result in health systems vulnerable to collapse when resources are strained, such as during pandemics. Although NCDs are largely preventable, globally there is underinvestment in efforts to address them. Integrating health systems to collectively address NCDs and infectious diseases through a wide range of services in a comprehensive manner reduces the economic burden of healthcare and strengthens the healthcare system. Health system resiliency is essential for health security. In this article, we provide an economically sound approach to incorporating NCDs into routine healthcare services in LMICs through improved alignment of institutions that support prevention and control of both NCDs and infectious diseases. Examples from Zambia's multisector interventions to develop and support a national NCD action plan can inform and encourage LMIC countries to invest in systems integration to reduce the social and economic burden of NCDs and infectious diseases. |
The cost-effectiveness of hyperlipidemia medication in low- and middle-income countries: A review
Husain MJ , Spencer G , Nugent R , Kostova D , Richter P . Glob Heart 2022 17 (1) 18 Hyperlipidemia is a risk factor for cardiovascular disease - the leading cause of death globally. Increased understanding of the cost-effectiveness of hyperlipidemia treatment in low- and middle-income countries can guide approaches to hyperlipidemia management in resource-limited environments. We conducted a systematic review of the evidence on the cost-effectiveness of hyperlipidemia medication treatment in low- and middle-income countries using studies published between January 2010 and April 2020. We abstracted study details, including study design, treatment setting, intervention type, health metrics, costs standardized to constant 2019 US dollars, and cost-effectiveness measures including average and incremental cost-effectiveness ratios. Comparisons across studies suggested that treatment via polypill is generally more cost-effective than statin-only therapy, and that primary prevention is more cost-effective than secondary prevention. Treating hyperlipidemia at a threshold of 5.7 mmol/l comes at a higher cost per disability-adjusted life-years averted than at a threshold of 6.2 mmol/l. Most pharmacological treatment strategies for hyperlipidemia were found to be cost-effective in most of the examined low- and middle-income countries. |
Microneedle patch as a new platform to effectively deliver inactivated polio vaccine and inactivated rotavirus vaccine
Moon SS , Richter-Roche M , Resch TK , Wang Y , Foytich KR , Wang H , Mainou BA , Pewin W , Lee J , Henry S , McAllister DV , Jiang B . NPJ Vaccines 2022 7 (1) 26 We recently reported a lack of interference between inactivated rotavirus vaccine (IRV) and inactivated poliovirus vaccine (IPV) and their potential dose sparing when the two vaccines were administered intramuscularly either in combination or standalone in rats and guinea pigs. In the present study, we optimized the formulations of both vaccines and investigated the feasibility of manufacturing a combined IRV-IPV dissolving microneedle patch (dMNP), assessing its compatibility and immunogenicity in rats. Our results showed that IRV delivered by dMNP alone or in combination with IPV induced similar levels of RV-specific IgG and neutralizing antibody. Likewise, IPV delivered by dMNP alone or in combination with IRV induced comparable levels of neutralizing antibody of poliovirus types 1, 2, and 3. We further demonstrated high stability of IRV-dMNP at 5, 25, and 40 °C and IPV-dMNP at 5 and 25 °C, and found that three doses of IRV or IPV when co-administered at a quarter dose was as potent as a full target dose in inducing neutralizing antibodies against corresponding rotavirus or poliovirus. We conclude that IRV-IPV dMNP did not interfere with each other in triggering an immunologic response and were highly immunogenic in rats. Our findings support the further development of this innovative approach to deliver a novel combination vaccine against rotavirus and poliovirus in children throughout the world. |
Cost assessment of a program for laboratory testing of plasma trans-fatty acids in Thailand
Datta BK , Aekplakorn W , Chittamma A , Meemeaw P , Vesper H , Kuiper HC , Steele L , Cobb LK , Li C , Husain MJ , Ketgudee L , Kostova D , Richter P . Public Health Pract (Oxf) 2021 2 100199 Objectives: Intake of trans fatty acids (TFA) increases the risk of cardiovascular disease. Assessment of TFA exposure in the population is key for determining TFA burden and monitoring change over time. One approach for TFA monitoring is measurement of TFA levels in plasma. Understanding costs associated with this approach can facilitate program planning, implementation and scale-up. This report provides an assessment of costs associated with a pilot program to measure plasma TFA levels in Thailand. Study design: Cost analysis in a laboratory facility in Thailand. Methods: We defined three broad cost modules: laboratory, personnel, and facility costs, which were further classified into sub-components and into fixed and variable categories. Costs were estimated based on the number of processed plasma samples (100–2700 in increments of 50) per year over a certain number of years (1–5), in both USD and Thai Baht. Total cost and average costs per sample were estimated across a range of samples processed. Results: The average cost per sample of analyzing 900 samples annually over 5 years was estimated at USD186. Laboratory, personnel, and facility costs constitute 67%, 23%, and 10% of costs, respectively. The breakdown across fixed costs, such as laboratory instruments and personnel, and variable costs, such as chemical supplies, was 60% and 40%, respectively. Average costs decline as more samples are processed: the cost per sample for analyzing 100, 500, 1500, and 2500 samples per year over 5 years is USD1351, USD301, USD195; and USD177, respectively. Conclusions: Laboratory analysis of plasma TFA levels has high potential for economies of scale, encouraging a long-term approach to TFA monitoring initiatives, particularly in countries that already maintain national biometric repositories. © 2021 The Authors |
Diabetes, obesity, hypertension and risk of severe COVID-19: a protocol for systematic review and meta-analysis.
Li C , Islam N , Gutierrez JP , Lacey B , Moolenaar RL , Richter P . BMJ Open 2021 11 (11) e051711 INTRODUCTION: Previous evidence from several countries, including China, Italy, Mexico, UK and the USA, indicates that among patients with confirmed COVID-19 who were hospitalised, diabetes, obesity and hypertension might be important risk factors for severe clinical outcomes. Several preliminary systematic reviews and meta-analyses have been conducted on one or more of these non-communicable diseases, but the findings have not been definitive, and recent evidence has become available from many more populations. Thus, we aim to conduct a systematic review and meta-analysis of observational studies to assess the relationship of diabetes, obesity and hypertension with severe clinical outcomes in patients with COVID-19. METHOD AND ANALYSIS: We will search 16 major databases (MEDLINE, Embase, Global Health, CAB Abstracts, PsycINFO, CINAHL, Academic Research Complete, Africa Wide Information, Scopus, PubMed Central, ProQuest Central, WHO Virtual Health Library, Homeland Security COVID-19 collection, SciFinder, Clinical Trials and Cochrane Library) for articles published between December 2019 and December 2020. We will follow the Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols 2016 guidelines for the design and reporting the results. We will include observational studies that assess the associations of pre-existing diabetes, obesity and hypertension in patients with COVID-19 with risk of severe clinical outcomes such as intensive care unit admission, receiving mechanical ventilation or death. Stata V.16.1 and R-Studio V.1.4.1103 statistical software will be used for statistical analysis. Meta-analysis will be used to estimate the pooled risks and to assess potential heterogeneities in risks. ETHICS AND DISSEMINATION: The study was reviewed for human subjects concerns by the US CDC Center for Global Health and determined to not represent human subjects research because it uses data from published studies. We plan to publish results in a peer-reviewed journal and present at national and international conferences. PROSPERO REGISTRATION NUMBER: CRD42021204371. |
Strengthening Pandemic Preparedness Through Noncommunicable Disease Strategies
Kostova DA , Moolenaar RL , Van Vliet G , Lasu A , Mahar M , Richter P . Prev Chronic Dis 2021 18 E93 The COVID-19 pandemic has demonstrated the effect of noncommunicable diseases (NCDs) on infectious disease outcomes. This effect can be observed at both the individual and the population level. At the individual level, the presence of preexisting chronic conditions increases a patient’s risk of severe COVID-19 disease (1). At the population level, the aggregate prevalence of chronic conditions could compound the pandemic’s overall burden on health systems and the economy (2). |
Comparative potency analysis of whole smoke solutions in the bacterial reverse mutation test.
Meng F , Mei N , Yan J , Guo X , Richter PA , Chen T , De M . Mutagenesis 2021 36 (4) 321-329 ![]() Short-term in vitro genotoxicity assays are useful tools to assess whether new and emerging tobacco products potentially have reduced toxicity. We previously demonstrated that potency ranking by benchmark dose (BMD) analysis quantitatively identifies differences among several known carcinogens and toxic chemicals representing different chemical classes found in cigarette smoke. In this study, six whole smoke solution (WSS) samples containing both the particulate and gas phases of tobacco smoke were generated from two commercial cigarette brands under different smoking-machine regimens. Sixty test cigarettes of each brand were machine-smoked according to the International Organization for Standardization (ISO) puffing protocol. In addition, either 60 or 20 test cigarettes of each brand were machine-smoked with the Canadian Intense (CI) puffing protocol. All six WSSs were evaluated in the bacterial reverse mutation (Ames) test using Salmonella typhimurium strains, in the presence or absence of S9 metabolic activation. The resulting S9-mediated mutagenic concentration-responses for the four WSSs from 60 cigarettes were then compared using BMD modeling analysis and the mutagenic potency expressed as number of revertants per μl of the WSS. The quantitative approaches resulted in a similar rank order of mutagenic potency for the Ames test in both TA98 and TA100. Under the conditions of this study, these results indicate that quantitative analysis of the Ames test data can discriminate between the mutagenic potencies of WSSs on the basis of smoking-machine regimen (ISO vs. CI), and cigarette product (differences in smoke chemistry). |
Dietary Sources of Plasma trans Fatty Acids among Adults in the United States: NHANES 2009-2010
Li C , Richter P , Cobb LK , Kuiper HC , Seymour J , Vesper HW . Curr Dev Nutr 2021 5 (5) nzab063 BACKGROUND: Intake of trans fatty acids (TFAs) increases LDL cholesterol, decreases HDL cholesterol, and increases the risk of heart disease morbidity and mortality. Many food products potentially contain industrially produced or ruminant TFAs. However, little is known about the dietary sources of plasma TFA concentrations. OBJECTIVE: The objective of this study was to examine associations between foods consumed and plasma TFA concentrations using 24-h dietary recall data and plasma TFA measures among adults aged ≥20 y who participated in the NHANES 2009-2010 in the United States. METHODS: Over 4400 food products in the dietary interview data were categorized into 32 food and beverage groups/subgroups. Four major plasma TFAs (palmitelaidic acid, elaidic acid, vaccenic acid, linolelaidic acid) and the sum of the 4 TFAs (sumTFAs) were analyzed using GC-MS. Multivariable linear regression analyses were conducted to identify associations of plasma TFAs with all 32 food and beverage groups/subgroups, controlling for the potential confounding effects of 11 demographic, socioeconomic, behavioral, lifestyle, and health-related variables. RESULTS: Consumption of the following food groups/subgroups was significantly associated with elevated plasma TFA concentrations: cream substitutes (P < 0.001 for palmitelaidic acid, elaidic acid, vaccenic acid, and sumTFAs); cakes, cookies, pastries, and pies (P < 0.001 for elaidic acid, vaccenic acid, and sumTFAs; P < 0.05 for linolelaidic acid); milk and milk desserts (P < 0.01 for palmitelaidic acid and vaccenic acid; P < 0.05 for linolelaidic acid and sumTFAs); beef/veal, lamb/goat, and venison/deer (P < 0.01 for vaccenic acid; P < 0.05 for sumTFAs); and butters (P < 0.001 for palmitelaidic acid and vaccenic acid; P < 0.05 for sumTFAs). CONCLUSIONS: The findings suggest that the above 5 food groups/subgroups could be the main dietary sources of plasma TFAs among adults in the United States in 2009-2010. |
The Role of Noncommunicable Diseases in the Pursuit of Global Health Security
Kostova D , Richter P , Van Vliet G , Mahar M , Moolenaar RL . Health Secur 2021 19 (3) 288-301 Noncommunicable diseases and their risk factors are important for all aspects of outbreak preparedness and response, affecting a range of factors including host susceptibility, pathogen virulence, and health system capacity. This conceptual analysis has 2 objectives. First, we use the Haddon matrix paradigm to formulate a framework for assessing the relevance of noncommunicable diseases to health security efforts throughout all phases of the disaster life cycle: before, during, and after an event. Second, we build upon this framework to identify 6 technical action areas in global health security programs that are opportune integration points for global health security and noncommunicable disease objectives: surveillance, workforce development, laboratory systems, immunization, risk communication, and sustainable financing. We discuss approaches to integration with the goal of maximizing the reach of global health security where infectious disease threats and chronic disease burdens overlap. |
Noncommunicable disease outcomes and the effects of vertical and horizontal health aid
Kostova D , Nugent R , Richter P . Econ Hum Biol 2020 41 100935 Foreign health aid forms a substantial portion of health spending in many low- and middle-income countries (LMICs). It can be either vertical (funds earmarked for specific diseases) or horizontal (funds used for broad health sector strengthening). Historically, most health aid has been disbursed vertically toward key infectious diseases, with minimal allocations to noncommunicable diseases (NCDs). High NCD burden in LMICs underscores a need for increased assistance toward NCD objectives, but evidence on the outcomes of health aid for NCDs is sparse. We obtained annual data on cause-specific deaths and disability-adjusted life years (DALYs) for four leading NCDs across 116 countries, 2000-2016, and evaluated the relationship between these indicators and vertical and horizontal health aid using country fixed-effects models with 1-to-5-year lagged effects. After adjusting for fixed and time-variant country heterogeneity, vertical assistance for NCDs was significantly associated with subsequent reductions in NCD morbidity and mortality, particularly for persons under age 70 and for cardiovascular and chronic respiratory diseases. An additional dollar in per-capita NCD vertical assistance corresponded to reductions in the average annual NCD burden of 7,459 DALYs/281 deaths after one year, 7,728 DALYs/319 deaths after two years, and 8,957 DALYs/346 deaths after three years. The findings suggest that vertical assistance for NCD programs may be an appropriate mechanism for addressing short-term NCD needs in LMICs, where it may help to fill health sector gaps in NCD care, but longer-term evaluation is needed for assessing the role of horizontal assistance. |
Revisiting the association between worldwide implementation of the MPOWER package and smoking prevalence, 2008-2017
Husain MJ , Datta BK , Nargis N , Iglesias R , Perucic AM , Ahluwalia IB , Tripp A , Fatehin S , Husain MM , Kostova D , Richter P . Tob Control 2020 30 (6) 630-637 BACKGROUND: We revisited the association between progress in MPOWER implementation from 2008 to 2016 and smoking prevalence from 2009 to 2017 and offered an in-depth understanding of differential outcomes for various country groups. METHODS: We used data from six rounds of the WHO Reports on the Global Tobacco Epidemic and calculated a composite MPOWER Score for each country in each period. We categorised the countries in four initial conditions based on their tobacco control preparedness measured by MPOWER score in 2008 and smoking burden measured by age-adjusted adult daily smoking prevalence in 2006: (1) High MPOWER - high prevalence (HM-HP). (2) High MPOWER - low prevalence (HM-LP). (3) Low MPOWER - high prevalence (LM-HP). (4) Low MPOWER - low prevalence (LM-LP). We estimated the association of age-adjusted adult daily smoking prevalence with MPOWER Score and cigarette tax rates using two-way fixed-effects panel regression models including both year and country fixed effects. RESULTS: A unit increase of the MPOWER Score was associated with 0.39 and 0.50 percentage points decrease in adult daily smoking prevalence for HM-HP and HM-LP countries, respectively. When tax rate was controlled for separately from MPOWE, an increase in tax rate showed a negative association with daily smoking prevalence for HM-HP and LM-LP countries, while the MPOWE Score showed a negative association for all initial condition country groups except for LM-LP countries. CONCLUSION: A decade after the introduction of the WHO MPOWER package, we observed that the countries with higher initial tobacco control preparedness and higher smoking burden were able to reduce the adult daily smoking prevalence significantly. |
Expert opinion on verification of antimicrobial susceptibility tests
Patel JB , Thomson RB , Alby K , Babady E , Culbreath K , Galas MF , Lockhart SR , Lubbers BV , Morgan M , Richter SS , Sharp S , Shawar RM , Cardenas AM , Esparza G , Hubbard N , Papich MG , Schuetz AN . J Clin Microbiol 2020 58 (11) On behalf of the Clinical and Laboratory Standards Institute (CLSI), the Expert Panel on Microbiology would like to respond to the recent commentary by Kirby and colleagues voicing concerns related to verification of commercial antimicrobial susceptibility testing (AST) for new drugs that are introduced into the clinical laboratory (1)..... |
Access to cardiovascular disease and hypertension medicines in developing countries: An analysis of essential medicine lists, price, availability, and affordability
Husain MJ , Datta BK , Kostova D , Joseph KT , Asma S , Richter P , Jaffe MG , Kishore SP . J Am Heart Assoc 2020 9 (9) e015302 Background Access to medicines is important for long-term care of cardiovascular diseases and hypertension. This study provides a cross-country assessment of availability, prices, and affordability of cardiovascular disease and hypertension medicines to identify areas for improvement in access to medication treatment. Methods and Results We used the World Health Organization online repository of national essential medicines lists (EMLs) for 53 countries to transcribe the information on the inclusion of 12 cardiovascular disease/hypertension medications within each country's essential medicines list. Data on availability, price, and affordability were obtained from 84 surveys in 59 countries that used the World Health Organization's Health Action International survey methodology. We summarized and compared the indicators across lowest-price generic and originator brand medicines in the public and private sectors and by country income groups. The average availability of the select medications was 54% in low- and lower-middle-income countries and 60% in high- and upper-middle-income countries, and was higher for generic (61%) than brand medicines (41%). The average patient median price ratio was 80.3 for brand and 16.7 for generic medicines and was higher for patients in low- and lower-middle-income countries compared with high- and upper-middle-income countries across all medicine categories. The costs of 1 month's antihypertensive medications were, on average, 6.0 days' wage for brand medicine and 1.8 days' wage for generics. Affordability was lower in low- and lower-middle-income countries than high- and upper-middle-income countries for both brand and generic medications. Conclusions The availability and accessibility of pharmaceuticals is an ongoing challenge for health systems. Low availability and high costs are major barriers to the use of and adherence to essential cardiovascular disease and antihypertensive medications worldwide, particularly in low- and lower-middle-income countries. |
Taenia solium cysticercosis and taeniasis in urban settings: Epidemiological evidence from a health-center based study among people with epilepsy in Dar es Salaam, Tanzania
Schmidt V , O'Hara MC , Ngowi B , Herbinger KH , Noh J , Wilkins PP , Richter V , Kositz C , Matuja W , Winkler AS . PLoS Negl Trop Dis 2019 13 (12) e0007751 In Africa, urbanization is happening faster than ever before which results in new implications for transmission of infectious diseases. For the zoonotic parasite Taenia solium, a major cause of acquired epilepsy in endemic countries, the prevalence in urban settings is unknown. The present study investigated epidemiological, neurological, and radiological characteristics of T. solium cysticercosis and taeniasis (TSCT) in people with epilepsy (PWE) living in Dar es Salaam, Tanzania, one of the fastest growing cities worldwide. A total of 302 PWE were recruited from six health centers in the Kinondoni district of Dar es Salaam. Serological testing for T. solium cysticercosis-antigen (Ag) and -antibodies (Abs) and for T. solium taeniasis-Abs was performed in all PWE. In addition, clinical and radiological examinations that included cranial computed tomography (CT) were performed. With questionnaires, demographic data from study populations were collected, and factors associated with TSCT were assessed. Follow-up examinations were conducted in PWE with TSCT. T. solium cysticercosis-Ag was detected in three (0.99%; 95% CI: 0-2.11%), -Abs in eight (2.65%; 95% CI: 0.84-4.46%), and taeniasis-Abs in five (1.66%; 95% CI: 0.22-3.09%) of 302 PWE. Six PWE (1.99%; 95% CI: 0.41-3.56%) were diagnosed with neurocysticercosis (NCC). This study demonstrates the presence of TSCT in Dar es Salaam, however, NCC was only associated with a few cases of epilepsy. The small fraction of PWE with cysticercosis- and taeniasis-Abs may suggest that active transmission of T. solium plays only a minor role in Dar es Salaam. A sufficiently powered risk analysis was hampered by the small number of PWE with TSCT; therefore, further studies are required to determine the exact routes of infection and risk behavior of affected individuals. |
Mouth level nicotine in a clinical setting versus non-clinical setting
Watson CV , Richter P , Yao L , Phillips T , Pickworth WB , deCastro BR , Potts J , Watson C . Am J Health Behav 2019 43 (3) 229-241 Objective: Our objective was to improve understanding of the differences in cigarette use behavior and exposure for participants smoking their own brand of cigarettes in a clinical setting versus smoking under natural conditions. Methods: Adult daily smokers (N = 163) attended 2 clinic visits where they smoked through a CReSS topography device. Participants collected cigarette butts smoked without a CReSS device and completed a diary of location, mood, and activity for each cigarette smoked. Cigarette butts were used to determine mouth level nicotine (MLN). Least square means (LSMs) were estimated from mixed effects models. Results: The LSM for MLN was higher among participants who smoked cigarettes in the clinical setting. LSM MLN was 1.589 [95% CI: 1.312, 1.924] mg/cig for cigarettes smoked in the clinic and 1.087 [95% CI: 0.902, 1.310] mg/cig for cigarettes smoked outside of the clinic; we found differences between race and sex. Conclusions: Our results show nicotine intake and some smoking behavior are significantly biased upwards when studied in a clinical setting. Therefore, tobacco smoke exposure determinations in a clinical setting may not be completely generalizable to smoke exposure determinations in naturalistic settings. |
A Laboratory Medicine Best Practices Systematic Review and Meta-analysis of Nucleic Acid Amplification Tests (NAATs) and Algorithms Including NAATs for the Diagnosis of Clostridioides ( Clostridium ) difficile in Adults.
Kraft CS , Parrott JS , Cornish NE , Rubinstein ML , Weissfeld AS , McNult P , Nachamkin I , Humphries RM , Kirn TJ , Dien Bard J , Lutgring JD , Gullett JC , Bittencourt CE , Benson S , Bobenchik AM , Sautter RL , Baselski V , Atlas MC , Marlowe EM , Miller NS , Fischer M , Richter SS , Gilligan P , Snyder JW . Clin Microbiol Rev 2019 32 (3) ![]() ![]() SUMMARYThe evidence base for the optimal laboratory diagnosis of Clostridioides (Clostridium) difficile in adults is currently unresolved due to the uncertain performance characteristics and various combinations of tests. This systematic review evaluates the diagnostic accuracy of laboratory testing algorithms that include nucleic acid amplification tests (NAATs) to detect the presence of C. difficile The systematic review and meta-analysis included eligible studies (those that had PICO [population, intervention, comparison, outcome] elements) that assessed the diagnostic accuracy of NAAT alone or following glutamate dehydrogenase (GDH) enzyme immunoassays (EIAs) or GDH EIAs plus C. difficile toxin EIAs (toxin). The diagnostic yield of NAAT for repeat testing after an initial negative result was also assessed. Two hundred thirty-eight studies met inclusion criteria. Seventy-two of these studies had sufficient data for meta-analysis. The strength of evidence ranged from high to insufficient. The uses of NAAT only, GDH-positive EIA followed by NAAT, and GDH-positive/toxin-negative EIA followed by NAAT are all recommended as American Society for Microbiology (ASM) best practices for the detection of the C. difficile toxin gene or organism. Meta-analysis of published evidence supports the use of testing algorithms that use NAAT alone or in combination with GDH or GDH plus toxin EIA to detect the presence of C. difficile in adults. There is insufficient evidence to recommend against repeat testing of the sample using NAAT after an initial negative result due to a lack of evidence of harm (i.e., financial, length of stay, or delay of treatment) as specified by the Laboratory Medicine Best Practices (LMBP) systematic review method in making such an assessment. Findings from this systematic review provide clarity to diagnostic testing strategies and highlight gaps, such as low numbers of GDH/toxin/PCR studies, in existing evidence on diagnostic performance, which can be used to guide future clinical research studies. |
Cigarette whole smoke solutions disturb mucin homeostasis in a human in vitro airway tissue model
Cao X , Wang Y , Xiong R , Muskhelishvili L , Davis K , Richter PA , Heflich RH . Toxicology 2018 409 119-128 Many cigarette smoke-associated airway diseases involve alterations in mucin homeostasis. With the rationale that relevant tissue responses can be measured to evaluate the adverse health effects of tobacco products, we assessed changes in mucin secretion and the density and size of goblet cells in an in vitro human air-liquid-interface (ALI) airway tissue model after exposure to a tobacco smoke solution. Cultures were exposed daily for up to five consecutive days to a whole smoke solution (WSS) prepared by machine smoking Marlboro Red or Marlboro Silver cigarettes using the Canadian Intense (CI) protocol. Both WSSs induced concentration- and time-related hypersecretion of mucins 5AC and 5B, accompanied by up-regulation of the respective mucin genes. Mucin secretion returned to baseline levels following a 14-day recovery period. Mucin-secreting goblet cells exhibited increased cell density and decreased size after 5 daily treatments then recovered to their normal size, but with decreased cell density, 14 days after the last treatment. The beating frequency of ciliated cells, which plays a key role in mucociliary clearance, was increased by 5 daily treatments with the CI WSSs then reverted to baseline levels following a 7-day recovery. Taken together, our results indicate that ALI cultures can be used to measure the modulation of mucin production, secretion, and clearance, disturbances that are manifested in tobacco smoke-related diseases, such as chronic obstructive pulmonary disease. Measuring tissue responses directly relevant to the respiratory toxicity of cigarette smoke may provide useful information in support of science-based regulatory decisions. |
Evaluating the recombinant T24H enzyme-linked immunoelectrotransfer blot assay for the diagnosis of neurocysticercosis in a panel of samples from a large community-based randomized control trial in 60 villages in Burkina Faso
Dermauw V , Carabin H , Cisse A , Millogo A , Tarnagda Z , Ganaba R , Noh J , Handali S , Breen K , Richter V , Cisse R , Preux PM , Boncoeur-Martel MP , Winkler AS , Van Hul A , Dorny P , Gabriel S . Am J Trop Med Hyg 2018 98 (2) 565-569 Current guidelines for the diagnosis of neurocysticercosis (NCC) recommend the use of the lentil lectin-bound glycoprotein enzyme-linked immunoelectrotransfer blot assay (LLGP-EITB) as the reference standard for serological testing. In response to the drawbacks involved with the use of the LLGP-EITB, a recombinant T24H antigen (rT24H) EITB assay was developed, with promising results. However, the test has yet to be evaluated among individuals from sub-Saharan Africa (SSA). The aim of the present study was to investigate the performance of the rT24H EITB assay for the detection of NCC cases in a panel of serum samples (N = 366, of which 173 patients presented with epileptic seizures and/or severe chronic headaches, and 193 matched manifestation-free participants) collected as part of a large community-based trial in Burkina Faso. A perfect agreement between the rT24H EITB and the native gp24 (and its homodimer, gp42) LLGP-EITB was found (kappa value of 1.0). Furthermore, among patients with the neurological manifestations of interest who underwent a computed tomography scan, the rT24H EITB and native antigen LLGP-EITB had a comparable ability to correctly identify NCC cases with multiple viable (rT24H: sensitivity: 80.0%), single viable (66.7%), and calcified/degenerating cysts only (25.0%), albeit for multiple viable and calcified cysts, the rT24H estimated sensitivity seemed lower, but more uncertain, than previously reported. The rT24H EITB specificity was high (98.2%) and in line with previous studies. This study confirms the value of the recombinant rT24H EITB as an alternative to the native antigen LLGP-EITB for the diagnosis of NCC in a SSA community setting. |
Cigarette design features: Effects on emission levels, user perception, and behavior
Talhout R , Richter PA , Stepanov I , Watson CV , Watson CH . Tob Regul Sci 2018 4 (1) 592-604 Objectives: This paper describes the effects of non-tobacco, physical cigarette design features on smoke emissions, product appeal, and smoking behaviors - 3 factors that determine smoker's exposure and related health risks. Methods: We reviewed available evidence for the impact of filter ventilation, new filter types, and cigarettes dimensions on toxic emissions, smoker's perceptions, and behavior. For evidence sources we used scientific literature and websites providing product characteristics and marketing information. Results: Whereas filter ventilation results in lower machine-generated emissions, it also leads to perceptions of lighter taste and relative safety in smokers who can unwittingly employ more intense smoking behavior to obtain the desired amount of nicotine and sensory appeal. Filter additives that modify smoke emissions can also modify sensory cues, resulting in changes in smoking behavior. Flavor capsules increase the cigarette's appeal and novelty, and lead to misperceptions of reduced harm. Slim cigarettes have lower yields of some smoke emissions, but smoking behavior can be more intense than with standard cigarettes. Conclusions: Physical design features significantly impact machine-measured emission yields in cigarette smoke, product appeal, smoking behaviors, and exposures in smokers. The influence of current and emerging design features is important in understanding the effectiveness of regulatory actions to reduce smoking-related harm. |
Surveillance of nicotine and pH in cigarette and cigar filler
Lawler TS , Stanfill SB , deCastro BR , Lisko JG , Duncan BW , Richter P , Watson CH . Tob Regul Sci 2017 3 101-116 OBJECTIVE: We examined differences between nicotine concentrations and pH in cigarette and cigar tobacco filler. METHODS: Nicotine and pH levels for 50 cigarette and 75 cigar brands were measured. Non-mentholated and mentholated cigarette products were included in the analysis along with several cigar types as identified by the manufacturer: large cigars, pipe tobacco cigars, cigarillos, mini cigarillos, and little cigars. RESULTS: There were significant differences found between pH and nicotine for cigarette and cigar tobacco products. Mean nicotine concentrations in cigarettes (19.2 mg/g) and large cigars (15.4 mg/g) were higher than the other cigars types, especially the pipe tobacco cigars (8.79 mg/g). The mean pH for cigarettes was pH 5.46. Large cigars had the highest mean pH value (pH 6.10) and pipe tobacco cigars had the lowest (pH 5.05). CONCLUSIONS: Although cigarettes are the most common combustible tobacco product used worldwide, cigar use remains popular. Our research provides a means to investigate the possibility of distinguishing the 2 tobacco product types and offers information on nicotine and pH across a wide range of cigarette and cigar varieties that may be beneficial to help establish tobacco policies and regulations across product types. |
Cadmium and cadmium/zinc ratios and tobacco-related morbidities
Richter P , Faroon O , Pappas RS . Int J Environ Res Public Health 2017 14 (10) Metals are one of five major categories of carcinogenic or toxic constituents in tobacco and tobacco smoke. Cadmium is highly volatile and a higher percentage of the total tobacco cadmium content is efficiently transferred to mainstream tobacco smoke than many other toxic metals in tobacco. Inhaled cadmium bioaccumulates in the lungs and is distributed beyond the lungs to other tissues, with a total body biological half-life of one to two decades. Chronic cadmium exposure through tobacco use elevates blood and urine cadmium concentrations. Cadmium is a carcinogen, and an inducer of proinflammatory immune responses. Elevated exposure to cadmium is associated with reduced pulmonary function, obstructive lung disease, bronchogenic carcinoma, cardiovascular diseases including myocardial infarction, peripheral arterial disease, prostate cancer, cervical cancer, pancreatic cancer, and various oral pathologies. Cadmium and zinc have a toxicologically inverse relationship. Zinc is an essential element and is reportedly antagonistic to some manifestations of cadmium toxicity. This review summarizes associations between blood, urine, and tissue cadmium concentrations with emphasis on cadmium exposure due to tobacco use and several disease states. Available data about zinc and cadmium/zinc ratios and tobacco-related diseases is summarized from studies reporting smoking status. Collectively, data suggest that blood, urine, and tissue cadmium and cadmium/zinc ratios are often significantly different between smokers and nonsmokers and they are also different in smokers for several diseases and cancers. Additional biomonitoring data such as blood or serum and urine zinc and cadmium levels and cadmium/zinc ratios in smokers may provide further insight into the development and progression of diseases of the lung, cardiovascular system, and possibly other organs. |
Smoking behavior and exposure: Results of a menthol cigarette cross-over study
Watson CV , Richter P , de Castro BR , Sosnoff C , Potts J , Clark P , McCraw J , Yan X , Chambers D , Watson C . Am J Health Behav 2017 41 (3) 309-319 OBJECTIVE: Our objective was to improve understanding of the differences in use behavior and exposure when smoking menthol and non-menthol cigarettes using a 2-part cross-over design. METHODS: Adult daily smokers were assigned randomly to alternate between 2 weeks of exclusively smoking a menthol test cigarette or a non-menthol test cigarette. Urine and saliva were collected for biomarker measurements; carbon monoxide (CO) was measured, and participants smoked test cigarettes through a CreSS(R) smoking topography device during 3 clinic visits. Participants turned in their cigarette butts from the test periods for determination of mouth level nicotine and completed subjective questionnaires related to the test cigarettes. RESULTS: Regardless of cigarette preference, participants had higher salivary cotinine when smoking the non-menthol test cigarette, but there were no significant differences detected in urine 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol between the 2 test cigarettes. Mouth level nicotine, puff volume, and puff duration were significantly higher when smoking the menthol brand. Both menthol and non-menthol smokers reported significantly lower enjoyment and satisfaction scores for test cigarettes compared with their brand of choice. CONCLUSIONS: Our results suggest that mentholation has an effect on measures of smoking behavior and that mouth level nicotine is a useful indicator of between-brand smoke exposure. |
Chemical characterization of mainstream smoke from SPECTRUM VARIABLE NICOTINE RESEARCH CIGARETTES
Ding YS , Richter P , Hearn B , Zhang L , Bravo R , Yan X , Perez JJ , Chan M , Hughes J , Chen P , Chen W , Wong J , Holmberg S , Smith S , Larango M , Valentin-Blasini L , Watson CH . Tob Regul Sci 2017 3 (1) 81-94 OBJECTIVE: Our objective was to characterize mainstream smoke constituent deliveries from SPECTRUM variable nicotine research cigarettes under 2 machine smoking regimens. SPECTRUM cigarettes are manufactured by the 22nd Century company for the National Institute on Drug Abuse, National Institutes of Health to contain varying (including reduced) levels of nicotine. METHODS: Mainstream smoke constituent deliveries of "tar," nicotine, carbon monoxide, tobacco-specific nitrosamines (N'-nitrosonornicotine (NNN) and 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanone (NNK)), benzo[a]pyrene, aromatic amines, and carbonyls were analyzed in 23 varieties of SPECTRUM cigarettes using ISO 17025 accredited methods. RESULTS: Data are presented as means and standard deviations of 5 replicates for all analytes. CONCLUSIONS: Under the ISO smoking regimen, mean levels of many smoke emissions for SPECTRUM varieties were comparable to the 3R4F research cigarette. Calculated SPECTRUM elasticity ranged from 1.6 to 4.0. Accordingly, under intense machine smoking conditions differences in emissions of SPECTRUM cigarettes were apparent. In addition, NNN increased with smoke nicotine while the same rate of change was not seen for NNK. It is important to monitor levels of chemicals of public health concern and regulatory interest as technologies emerge to reduce levels of nicotine or other targeted chemicals in tobacco products. |
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