Last data update: Dec 02, 2024. (Total: 48272 publications since 2009)
Records 1-27 (of 27 Records) |
Query Trace: Njie F[original query] |
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Tobacco use among adults with disabilities in nine countries-Demographic and Health Survey, 2016-2021
Kress AC , Vashist A , Zhang QC , Dragicevic A , Njie GJ . PLOS Glob Public Health 2024 4 (6) e0003232 Few studies have investigated tobacco use among people with disabilities living in low- and middle-income countries (LMICs). We aimed to examine current tobacco use among men and women with disabilities using Demographic and Health Survey (DHS) data from 9 LMICs. We considered a respondent currently use tobacco products if they reported current use of any combustible/smoked tobacco products or smokeless tobacco products. We performed secondary analyses of DHS data from 2016-2021 collected in Haiti, Mali, Mauritania, Nigeria, Pakistan, Rwanda, South Africa, Timor-Leste, and Uganda. We examined marginal effects in logistic regression to calculate the adjusted prevalence and adjusted prevalence differences of tobacco use by disability status, controlling for selected sociodemographic characteristics. The adjusted prevalence of current use of tobacco products among women with a moderate/severe disability, mild disability, and no disability varied across countries, with medians of 1.9% (range = 0.1% [Mali] to 11.3% [Pakistan]), 3.2% (range = 0.9% [Nigeria] to 13.3% [South Africa]), and 2.3% (range = 0.5% [Nigeria] to 8.9% [South Africa]), respectively. For men with moderate/severe disability, the median adjusted prevalence for current use of tobacco products was 18.8% (range = 8.9% [Rwanda] to 55.0% [Timor-Leste]). The median prevalences of current use of tobacco products for men with mild disability and no disability were similar to those with moderate/severe disability, at 16.5% and 15.9%, respectively. Current tobacco product use among people with disabilities varied for countries included in our study; however, with few exceptions, current tobacco product use was similar across disability status groups. Additional research is warranted to determine whether our findings extend beyond the nine countries assessed here. It is important to consider the needs of people with disabilities in tobacco prevention, control, and cessation efforts so that this substantial population can benefit equitably from such programs, interventions, or policies. |
Exposure to anti- and pro-smoking messages among adults in China: Results from the Global Adult Tobacco Survey, 2018
Pei D , Popova L , Chowdhury P , Shi J , Njie G . PLoS One 2024 19 (6) e0304028 SIGNIFICANCE: For decades, tobacco advertisements and promotions have been common in mass media and public places in China. In 2015, China amended the Advertising Law to prohibit the distribution of tobacco advertising, while also initiating waves of tobacco control media campaigns. This study investigates the associations between exposure to anti- and pro-smoking messages, smoking status, and people's smoking-related beliefs and willingness to support tobacco control policies. METHODS: A secondary data analysis was performed with the 2018 Global Adult Tobacco Survey of 19,376 adults aged ≥15 years in China. Anti- and pro-smoking message exposures were measured as the sum of sources (media or places) where respondents have seen the messages. Multivariable logistic regression analyses were conducted to examine the relationships among smoking status, message exposure, and the outcome variables (health harm beliefs, support for increasing tax on cigarettes, support for using part of the increased tax on tobacco control) controlling for smoking status and demographic differences. RESULTS: Overall, 63.3% of the respondents reported being exposed to anti-smoking messages from at least 1 source, while 18.1% were exposed to pro-smoking messages from at least 1 source. Adults who currently, formerly, and never smoked differed in their beliefs about smoking and willingness to support tobacco control policies. Greater reported exposure to anti-smoking messages was positively associated with belief that smoking is harmful, support for increased cigarette tax, and support for using increased tax revenue for tobacco control measures. Meanwhile, greater reported exposure to pro-smoking messages was negatively related to willingness to support cigarette tax increases. CONCLUSIONS: While national and local tobacco control campaigns in China have reached a large proportion of the adult population, there is still room for improvement. China might consider expanding anti-tobacco campaigns, as reported exposure to these messages is associated with increased public awareness of the health hazards of smoking and support for increasing cigarette taxes. |
Pregnancy-related deaths due to hemorrhage: Pregnancy Mortality Surveillance System, 2012-2019
Hollier LM , Busacker A , Njie F , Syverson C , Goodman DA . Obstet Gynecol 2024 Hemorrhage has been a leading cause of pregnancy-related death in the Centers for Disease Control and Prevention Pregnancy Mortality Surveillance System since 1987 when reporting began. Pregnancy Mortality Surveillance System data from 2012 to 2019 were analyzed to describe pregnancy-related deaths from hemorrhage. Pregnancy-related mortality ratios were estimated for hemorrhage overall and by hemorrhage subclassifications. Specific subclassifications of hemorrhage-related deaths were analyzed by sociodemographic characteristics. Overall, there were 606 deaths due to hemorrhage. The pregnancy-related mortality ratio for hemorrhage overall was 1.94 per 100,000 live births. Ruptured ectopic pregnancy was the most frequent subclassification (22.9%) of pregnancy-related hemorrhage deaths, followed by postpartum hemorrhage (21.2%). There were no significant trends in the pregnancy-related mortality ratio, overall or among any subclassification of hemorrhage deaths, from 2012 to 2019. Reporting subclassifications of pregnancy-related hemorrhage deaths could improve the ability to focus interventions and assess progress over time. |
A measles and rubella vaccine microneedle patch in The Gambia: a phase 1/2, double-blind, double-dummy, randomised, active-controlled, age de-escalation trial
Adigweme I , Yisa M , Ooko M , Akpalu E , Bruce A , Donkor S , Jarju LB , Danso B , Mendy A , Jeffries D , Segonds-Pichon A , Njie A , Crooke S , El-Badry E , Johnstone H , Royals M , Goodson JL , Prausnitz MR , McAllister DV , Rota PA , Henry S , Clarke E . Lancet 2024 BACKGROUND: Microneedle patches (MNPs) have been ranked as the highest global priority innovation for overcoming immunisation barriers in low-income and middle-income countries. This trial aimed to provide the first data on the tolerability, safety, and immunogenicity of a measles and rubella vaccine (MRV)-MNP in children. METHODS: This single-centre, phase 1/2, double-blind, double-dummy, randomised, active-controlled, age de-escalation trial was conducted in The Gambia. To be eligible, all participants had to be healthy according to prespecified criteria, aged 18-40 years for the adult cohort, 15-18 months for toddlers, or 9-10 months for infants, and to be available for visits throughout the follow-up period. The three age cohorts were randomly assigned in a 2:1 ratio (adults) or 1:1 ratio (toddlers and infants) to receive either an MRV-MNP (Micron Biomedical, Atlanta, GA, USA) and a placebo (0·9% sodium chloride) subcutaneous injection, or a placebo-MNP and an MRV subcutaneous injection (MRV-SC; Serum Institute of India, Pune, India). Unmasked staff ransomly assigned the participants using an online application, and they prepared visually identical preparations of the MRV-MNP or placebo-MNP and MRV-SC or placebo-SC, but were not involved in collecting endpoint data. Staff administering the study interventions, participants, parents, and study staff assessing trial endpoints were masked to treatment allocation. The safety population consists of all vaccinated participants, and analysis was conducted according to route of MRV administration, irrespective of subsequent protocol deviations. The immunogenicity population consisted of all vaccinated participants who had a baseline and day 42 visit result available, and who had no protocol deviations considered to substantially affect the immunogenicity endpoints. Solicited local and systemic adverse events were collected for 14 days following vaccination. Unsolicited adverse events were collected to day 180. Age de-escalation between cohorts was based on the review of the safety data to day 14 by an independent data monitoring committee. Serum neutralising antibodies to measles and rubella were measured at baseline, day 42, and day 180. Analysis was descriptive and included safety events, seroprotection and seroconversion rates, and geometric mean antibody concentrations. The trial was registered with the Pan African Clinical Trials Registry PACTR202008836432905, and is complete. FINDINGS: Recruitment took place between May 18, 2021, and May 27, 2022. 45 adults, 120 toddlers, and 120 infants were randomly allocated and vaccinated. There were no safety concerns in the first 14 days following vaccination in either adults or toddlers, and age de-escalation proceeded accordingly. In infants, 93% (52/56; 95% CI 83·0-97·2) seroconverted to measles and 100% (58/58; 93·8-100) seroconverted to rubella following MRV-MNP administration, while 90% (52/58; 79·2-95·2) and 100% (59/59; 93·9-100) seroconverted to measles and rubella respectively, following MRV-SC. Induration at the MRV-MNP application site was the most frequent local reaction occurring in 46 (77%) of 60 toddlers and 39 (65%) of 60 infants. Related unsolicited adverse events, most commonly discolouration at the application site, were reported in 35 (58%) of 60 toddlers and 57 (95%) of 60 infants that had received the MRV-MNP. All local reactions were mild. There were no related severe or serious adverse events. INTERPRETATION: The safety and immunogenicity data support the accelerated development of the MRV-MNP. FUNDING: Bill & Melinda Gates Foundation. |
Tolerability, safety, and immunogenicity of the novel oral polio vaccine type 2 in children aged 6 weeks to 59 months in an outbreak response campaign in The Gambia: an observational cohort study
Bashorun AO , Kotei L , Jawla O , Jallow AF , Saidy AJ , Kinteh MA , Kujabi A , Jobarteh T , Kanu FJ , Donkor SA , Ezeani E , Fofana S , Njie M , Ceesay L , Jafri B , Williams A , Jeffries D , Kotanmi B , Mainou BA , Ooko M , Clarke E . Lancet Infect Dis 2024 BACKGROUND: Novel oral polio vaccine type 2 (nOPV2) has been used to interrupt circulating vaccine-derived poliovirus type 2 outbreaks following its WHO emergency use listing. This study reports data on the safety and immunogenicity of nOPV2 over two rounds of a campaign in The Gambia. METHODS: This observational cohort study collected baseline symptoms (vomiting, diarrhoea, irritability, reduced feeding, and reduced activity) and axillary temperature from children aged 6 weeks to 59 months in The Gambia before a series of two rounds of a nOPV2 campaign that took place on Nov 20-26, 2021, and March 19-22, 2022. Serum and stool samples were collected from a subset of the participants. The same symptoms were re-assessed during the week following each dose of nOPV2. Stool samples were collected on days 7 and 28, and serum was collected on day 28 following each dose. Adverse events, including adverse events of special interest, were documented for 28 days after each campaign round. Serum neutralising antibodies were measured by microneutralisation assay, and stool poliovirus excretion was measured by real-time RT-PCR. FINDINGS: Of the 5635 children eligible for the study, 5504 (97·7%) received at least one dose of nOPV2. There was no increase in axillary temperature or in any of the baseline symptoms following either rounds of the campaigns. There were no adverse events of special interest and no other safety signals of concern. Poliovirus type 2 seroconversion rates were 70% (95% CI 62 to 78; 87 of 124 children) following one dose of nOPV2 and 91% (85 to 95; 113 of 124 children) following two doses. Poliovirus excretion on day 7 was lower after the second round (162 of 459 samples; 35·3%, 95% CI 31·1 to 39·8) than after the first round (292 of 658 samples; 44·4%, 40·6 to 48·2) of the campaign (difference -9·1%; 95% CI -14·8 to -3·3), showing the induction of mucosal immunity. INTERPRETATION: In a campaign in west Africa, nOPV2 was well tolerated and safe. High rates of seroconversion and evidence of mucosal immunity support the licensure and WHO prequalification of this vaccine. FUNDING: Bill & Melinda Gates Foundation. |
Gender differences in use of cigarette and non-cigarette tobacco products among adolescents aged 13-15 years in 20 African countries
Agaku IT , Sulentic R , Dragicevic A , Njie G , Jones CK , Odani S , Tsafa T , Gwar J , Vardavas CI , Ayo-Yusuf O . Tob Induc Dis 2024 22 INTRODUCTION: Examining gender differences in youth tobacco use is important as it aligns tobacco control within the context of broader human development goals seeking to eliminate gender inequalities. In this study, we examined gender differences in adolescent use of cigarettes, smokeless tobacco, shisha, and e-cigarettes in Africa. METHODS: This was a cross-sectional study using data from the Global Youth Tobacco Survey. Our analytical sample comprised 56442 adolescents aged 13-15 years from 20 African countries. Weighted, country-specific prevalence estimates were computed overall and by gender. Adjusted prevalence ratios (APRs) were calculated in a multivariable Poisson regression model to examine whether correlates of tobacco use differed between boys and girls. RESULTS: Ever cigarette smoking prevalence was significantly higher among boys than girls in 16 of the 20 countries, but a significantly higher percentage of girls reported earlier age of cigarette smoking initiation than boys within pooled analysis. Some of the largest gender differences in current cigarette smoking were seen in Algeria (12.2% vs 0.8%, boys and girls, respectively), Mauritius (21.2% vs 6.6%), and Madagascar (15.0% vs 4.1%). Current use of e-cigarettes, shisha, and smokeless tobacco was generally comparable between boys and girls where data existed. Among girls, higher levels of reported exposure to tobacco advertisement were positively associated with shisha smoking whereas perceived tobacco harm was inversely associated with current cigarette and shisha smoking. Among boys, perceived social acceptability of smoking at parties was associated with an increased likelihood of cigarette smoking (APR=2.27; 95% Cl: 1.20-4.30). CONCLUSIONS: The prevalence of cigarette smoking among boys was higher than that of girls in many countries. However, girls who smoke tend to start at an earlier age than boys. Differential gender patterns of cigarette and non-cigarette tobacco product use among youth may have implications for future disease burden. As the tobacco control landscape evolves, tobacco prevention efforts should focus on all tobacco products, not just cigarettes. |
Prevalence and covariates of electronic cigarette use among students aged 13-15 years in the Philippines: 2019 Global Youth Tobacco Survey
Serra C , Njie G , Jacques N , Pan L . Int J Environ Res Public Health 2023 20 (24) Electronic cigarette use is growing in popularity and accessibility among youth in the Southeast Asia region. We analyzed data on 6670 students, aged 13-15 years, from the Philippines' 2019 Global Youth Tobacco Survey. Prevalence estimates and 95% confidence intervals (CI) were estimated for current use (i.e., past 30 days), ever use, and awareness of e-cigarettes. Chi-square tests compared prevalence differences between groups. Multiple logistic regression models assessed factors associated with e-cigarette use while controlling for sociodemographic characteristics, current use of other tobacco products, and secondhand smoke exposure. Prevalence of current e-cigarette use was 14.1% (95% CI = 12.4%, 15.8%), ever use was 24.6% (95% CI = 22.4%, 26.9%), and awareness was 75.5% (95% CI = 73.0%, 78.0%). Current use of any other tobacco products and exposure to secondhand smoke at home, school, or other public places were positively associated with current and ever use of e-cigarettes. Boys and youth living in Luzon or Mindanao had higher odds of current e-cigarette use compared to girls and youth in Visayas. Findings indicated that one in four Philippine students aged 13-15 years ever used e-cigarettes and one in seven currently use e-cigarettes. This study highlights the importance of implementing evidence-based strategies, including relevant tobacco control policies. |
Pregnancy-related deaths by Hispanic origin, United States, 2009-2018
Parker-Collins W , Njie F , Goodman DA , Cox S , Chang J , Petersen EE , Beauregard JL . J Womens Health (Larchmt) 2023 32 (12) 1320-1327 Objective: To describe pregnancy-related mortality among Hispanic people by place of origin (country or region of Hispanic ancestry), 2009-2018. Materials and Methods: We conducted a cross-sectional descriptive study of pregnancy-related deaths among Hispanic people, stratified by place of origin (Central or South America, Cuba, Dominican Republic, Mexico, Puerto Rico, Other and Unknown Hispanic), using Pregnancy Mortality Surveillance System data, 2009-2018. We describe distributions of pregnancy-related deaths and pregnancy-related mortality ratios (number of pregnancy-related deaths per 100,000 live births) overall and by place of origin for select demographic and clinical characteristics. Results: For 2009-2018, the overall pregnancy-related mortality ratio among Hispanic people was 11.5 pregnancy-related deaths per 100,000 live births (95% confidence intervals [CI]: 10.8-12.2). In general, pregnancy-related mortality ratios were higher among older age groups (i.e., 35 years and older) and lower among those with higher educational attainment (i.e., college degree or higher). Approximately two in five pregnancy-related deaths among Hispanic people occurred on the day of delivery through 6 days postpartum. Place of origin-specific pregnancy-related mortality ratios ranged from 9.6 (95% CI: 5.8-15.0) among people of Cuban origin to 15.3 (95% CI: 12.4-18.3) among people of Puerto Rican origin. Hemorrhage and infection were the most frequent causes of pregnancy-related deaths overall among Hispanic people. People of Puerto Rican origin had a higher proportion of deaths because of cardiomyopathy. Conclusions: We identified differences in pregnancy-related mortality by place of origin among Hispanic people that can help inform prevention of pregnancy-related deaths. |
Changes in tobacco product use among students aged 13 to 15 years in 34 countries, Global Youth Tobacco Survey, 2012-2020
Njie GJ , Kirksey Jones C , Jacques N , Adetokun A , Ross J , Owens A , Anton L , Johns M , Pan L . Prev Chronic Dis 2023 20 E68 INTRODUCTION: Most adults who currently use tobacco start before age 21. Comprehensive, cost-effective strategies and interventions to prevent initiation and encourage tobacco use cessation among youth are critical aspects of protecting youth from the harms of commercial tobacco. We describe changes in current tobacco product use among youth in 34 sites using data from the Global Youth Tobacco Survey (GYTS). METHODS: GYTS is a nationally representative school-based survey of students aged 13 to 15 years. The analysis included 34 sites that completed 2 survey waves during 2012-2020. Prevalence of current tobacco use was assessed for each country. Marginal effects in multivariable logistic regression models were used to estimate adjusted prevalence difference (aPD) between waves. RESULTS: The adjusted prevalence of current tobacco product use remained unchanged in more than 60% of the included sites. For any tobacco use, significant decreases were reported for Bhutan (aPD = -8.1; 95% CI, -12.9 to -3.4), Micronesia (aPD = -7.2; 95% CI, -9.7 to -4.7), San Marino (aPD = -7.0; 95% CI, -11.2 to -2.7), Togo (aPD = -2.7; 95% CI, -4.6 to -0.7), and Panama (aPD = -2.2; 95% CI, -4.1 to -0.4); significant increases were reported for Moldova, Albania, and Paraguay. Current e-cigarette use increased significantly in 7 of 10 sites. CONCLUSION: Data show that progress toward reducing tobacco use among youth stalled during 2012-2020, while e-cigarette use increased in a few sites with available data. |
Lessons learned from CDC's Global COVID-19 early warning and response surveillance system
Ricks PM , Njie GJ , Dawood FS , Blain AE , Winstead A , Popoola A , Jones C , Li C , Fuller J , Anantharam P , Olson N , Walker AT , Biggerstaff M , Marston BJ , Arthur RR , Bennett SD , Moolenaar RL . Emerg Infect Dis 2022 28 (13) S8-s16 Early warning and response surveillance (EWARS) systems were widely used during the early COVID-19 response. Evaluating the effectiveness of EWARS systems is critical to ensuring global health security. We describe the Centers for Disease Control and Prevention (CDC) global COVID-19 EWARS (CDC EWARS) system and the resources CDC used to gather, manage, and analyze publicly available data during the prepandemic period. We evaluated data quality and validity by measuring reporting completeness and compared these with data from Johns Hopkins University, the European Centre for Disease Prevention and Control, and indicator-based data from the World Health Organization. CDC EWARS was integral in guiding CDC's early COVID-19 response but was labor-intensive and became less informative as case-level data decreased and the pandemic evolved. However, CDC EWARS data were similar to those reported by other organizations, confirming the validity of each system and suggesting collaboration could improve EWARS systems during future pandemics. |
Study protocol for a phase 1/2, single-centre, double-blind, double-dummy, randomized, active-controlled, age de-escalation trial to assess the safety, tolerability and immunogenicity of a measles and rubella vaccine delivered by a microneedle patch in healthy adults (18 to 40 years), measles and rubella vaccine-primed toddlers (15 to 18 months) and measles and rubella vaccine-nave infants (9 to 10 months) in The Gambia [Measles and Rubella Vaccine Microneedle Patch Phase 1/2 Age De-escalation Trial]
Adigweme I , Akpalu E , Yisa M , Donkor S , Jarju LB , Danso B , Mendy A , Jeffries D , Njie A , Bruce A , Royals M , Goodson JL , Prausnitz MR , McAllister D , Rota PA , Henry S , Clarke E . Trials 2022 23 (1) 775 BACKGROUND: New strategies to increase measles and rubella vaccine coverage, particularly in low- and middle-income countries, are needed if elimination goals are to be achieved. With this regard, measles and rubella vaccine microneedle patches (MRV-MNP), in which the vaccine is embedded in dissolving microneedles, offer several potential advantages over subcutaneous delivery. These include ease of administration, increased thermostability, an absence of sharps waste, reduced overall costs and pain-free administration. This trial will provide the first clinical trial data on MRV-MNP use and the first clinical vaccine trial of MNP technology in children and infants. METHODS: This is a phase 1/2, randomized, active-controlled, double-blind, double-dummy, age de-escalation trial. Based on the defined eligibility criteria for the trial, including screening laboratory investigations, 45 adults [18-40 years] followed by 120 toddlers [15-18 months] and 120 infants [9-10 months] will be enrolled in series. To allow double-blinding, participants will receive either the MRV-MNP and a placebo (0.9% sodium chloride) subcutaneous (SC) injection or a placebo MNP and the MRV by SC injection (MRV-SC). Local and systemic adverse event data will be collected for 14 days following study product administration. Safety laboratories will be repeated on day 7 and, in the adult cohort alone, on day 14. Unsolicited adverse events including serious adverse events will be collected until the final study visit for each participant on day 180. Measles and rubella serum neutralizing antibodies will be measured at baseline, on day 42 and on day 180. Cohort progression will be dependent on review of the unblinded safety data by an independent data monitoring committee. DISCUSSION: This trial will provide the first clinical data on the use of a MNP to deliver the MRV and the first data on the use of MNPs in a paediatric population. It will guide future product development decisions for what may be a key technology for future measles and rubella elimination. TRIAL REGISTRATION: Pan-African Clinical Trials Registry 202008836432905 . CLINICALTRIALS: gov NCT04394689. |
Prevalence of tuberculosis and mental disorders comorbidity: A systematic review and meta-analysis
Njie GJ , Khan A . J Immigr Minor Health 2021 24 (6) 1550-1556 Persons with tuberculosis (TB) also often have a mental disorder (MD). We examined TB-MD comorbidity prevalence and its impact on TB treatment outcomes as reported in studies set in the United States or in the top five countries of origin (Mexico, the Philippines, India, Vietnam, and China) for non-US-born persons with TB. We searched MEDLINE, EMBASE, OVID, PsycINFO, CINAHL, and Scopus for articles published from database inception through September 2018. Of the 9 studies analyzed, one was set in the United States. The estimated pooled prevalence of comorbid TB-MD from eight non-US studies, with 2921 participants, was 34.0% [95% confidence interval (CI) 21.1%-49.5%]. Comorbid TB-MD prevalence varied by country in the studies evaluated. Additional research might elucidate the extent of TB-MD in the United States and the top five countries of origin. |
Racial and Ethnic Disparities in Incidence of SARS-CoV-2 Infection, 22 US States and DC, January 1-October 1, 2020.
Hollis ND , Li W , Van Dyke ME , Njie GJ , Scobie HM , Parker EM , Penman-Aguilar A , Clarke KEN . Emerg Infect Dis 2021 27 (5) 1477-1481 We examined disparities in cumulative incidence of severe acute respiratory syndrome coronavirus 2 by race/ethnicity, age, and sex in the United States during January 1-October 1, 2020. Hispanic/Latino and non-Hispanic Black, American Indian/Alaskan Native, and Native Hawaiian/other Pacific Islander persons had a substantially higher incidence of infection than non-Hispanic White persons. |
Observations of the global epidemiology of COVID-19 from the prepandemic period using web-based surveillance: a cross-sectional analysis.
Dawood FS , Ricks P , Njie GJ , Daugherty M , Davis W , Fuller JA , Winstead A , McCarron M , Scott LC , Chen D , Blain AE , Moolenaar R , Li C , Popoola A , Jones C , Anantharam P , Olson N , Marston BJ , Bennett SD . Lancet Infect Dis 2020 20 (11) 1255-1262 Background Scant data are available about global patterns of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) spread and global epidemiology of early confirmed cases of COVID-19 outside mainland China. We describe the global spread of SARS-CoV-2 and characteristics of COVID-19 cases and clusters before the characterisation of COVID-19 as a pandemic. METHODS: Cases of COVID-19 reported between Dec 31, 2019, and March 10, 2020 (ie, the prepandemic period), were identified daily from official websites, press releases, press conference transcripts, and social media feeds of national ministries of health or other government agencies. Case characteristics, travel history, and exposures to other cases were abstracted. Countries with at least one case were classified as affected. Early cases were defined as those among the first 100 cases reported from each country. Later cases were defined as those after the first 100 cases. We analysed reported travel to affected countries among the first case reported from each country outside mainland China, demographic and exposure characteristics among cases with age or sex information, and cluster frequencies and sizes by transmission settings. FINDINGS: Among the first case reported from each of 99 affected countries outside of mainland China, 75 (76%) had recent travel to affected countries; 60 (61%) had travelled to China, Italy, or Iran. Among 1200 cases with age or sex information, 874 (73%) were early cases. Among 762 early cases with age information, the median age was 51 years (IQR 35-63); 25 (3%) of 762 early cases occurred in children younger than 18 years. Overall, 21 (2%) of 1200 cases were in health-care workers and none were in pregnant women. 101 clusters were identified, of which the most commonly identified transmission setting was households (76 [75%]; mean 2·6 cases per cluster [range 2-7]), followed by non-health-care occupational settings (14 [14%]; mean 4·3 cases per cluster [2-14]), and community gatherings (11 [11%]; mean 14·2 cases per cluster [4-36]). INTERPRETATION: Cases with travel links to China, Italy, or Iran accounted for almost two-thirds of the first reported COVID-19 cases from affected countries. Among cases with age information available, most were among adults aged 18 years and older. Although there were many clusters of household transmission among early cases, clusters in occupational or community settings tended to be larger, supporting a possible role for physical distancing to slow the progression of SARS-CoV-2 spread. FUNDING: None. |
Guidelines for the treatment of latent tuberculosis infection: Recommendations from the National Tuberculosis Controllers Association and CDC, 2020
Sterling TR , Njie G , Zenner D , Cohn DL , Reves R , Ahmed A , Menzies D , Horsburgh CRJr , Crane CM , Burgos M , LoBue P , Winston CA , Belknap R . MMWR Recomm Rep 2020 69 (1) 1-11 Comprehensive guidelines for treatment of latent tuberculosis infection (LTBI) among persons living in the United States were last published in 2000 (American Thoracic Society. CDC targeted tuberculin testing and treatment of latent tuberculosis infection. Am J Respir Crit Care Med 2000;161:S221-47). Since then, several new regimens have been evaluated in clinical trials. To update previous guidelines, the National Tuberculosis Controllers Association (NTCA) and CDC convened a committee to conduct a systematic literature review and make new recommendations for the most effective and least toxic regimens for treatment of LTBI among persons who live in the United States.The systematic literature review included clinical trials of regimens to treat LTBI. Quality of evidence (high, moderate, low, or very low) from clinical trial comparisons was appraised using the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) criteria. In addition, a network meta-analysis evaluated regimens that had not been compared directly in clinical trials. The effectiveness outcome was tuberculosis disease; the toxicity outcome was hepatotoxicity. Strong GRADE recommendations required at least moderate evidence of effectiveness and that the desirable consequences outweighed the undesirable consequences in the majority of patients. Conditional GRADE recommendations were made when determination of whether desirable consequences outweighed undesirable consequences was uncertain (e.g., with low-quality evidence).These updated 2020 LTBI treatment guidelines include the NTCA- and CDC-recommended treatment regimens that comprise three preferred rifamycin-based regimens and two alternative monotherapy regimens with daily isoniazid. All recommended treatment regimens are intended for persons infected with Mycobacterium tuberculosis that is presumed to be susceptible to isoniazid or rifampin. These updated guidelines do not apply when evidence is available that the infecting M. tuberculosis strain is resistant to both isoniazid and rifampin; recommendations for treating contacts exposed to multidrug-resistant tuberculosis were published in 2019 (Nahid P, Mase SR Migliori GB, et al. Treatment of drug-resistant tuberculosis. An official ATS/CDC/ERS/IDSA clinical practice guideline. Am J Respir Crit Care Med 2019;200:e93-e142). The three rifamycin-based preferred regimens are 3 months of once-weekly isoniazid plus rifapentine, 4 months of daily rifampin, or 3 months of daily isoniazid plus rifampin. Prescribing providers or pharmacists who are unfamiliar with rifampin and rifapentine might confuse the two drugs. They are not interchangeable, and caution should be taken to ensure that patients receive the correct medication for the intended regimen. Preference for these rifamycin-based regimens was made on the basis of effectiveness, safety, and high treatment completion rates. The two alternative treatment regimens are daily isoniazid for 6 or 9 months; isoniazid monotherapy is efficacious but has higher toxicity risk and lower treatment completion rates than shorter rifamycin-based regimens.In summary, short-course (3- to 4-month) rifamycin-based treatment regimens are preferred over longer-course (6-9 month) isoniazid monotherapy for treatment of LTBI. These updated guidelines can be used by clinicians, public health officials, policymakers, health care organizations, and other state and local stakeholders who might need to adapt them to fit individual clinical circumstances. |
Tuberculosis screening, testing, and treatment of U.S. health care personnel: Recommendations from the National Tuberculosis Controllers Association and CDC, 2019
Sosa LE , Njie GJ , Lobato MN , Bamrah Morris S , Buchta W , Casey ML , Goswami ND , Gruden M , Hurst BJ , Khan AR , Kuhar DT , Lewinsohn DM , Mathew TA , Mazurek GH , Reves R , Paulos L , Thanassi W , Will L , Belknap R . MMWR Morb Mortal Wkly Rep 2019 68 (19) 439-443 The 2005 CDC guidelines for preventing Mycobacterium tuberculosis transmission in health care settings include recommendations for baseline tuberculosis (TB) screening of all U.S. health care personnel and annual testing for health care personnel working in medium-risk settings or settings with potential for ongoing transmission (1). Using evidence from a systematic review conducted by a National Tuberculosis Controllers Association (NTCA)-CDC work group, and following methods adapted from the Guide to Community Preventive Services (2,3), the 2005 CDC recommendations for testing U.S. health care personnel have been updated and now include 1) TB screening with an individual risk assessment and symptom evaluation at baseline (preplacement); 2) TB testing with an interferon-gamma release assay (IGRA) or a tuberculin skin test (TST) for persons without documented prior TB disease or latent TB infection (LTBI); 3) no routine serial TB testing at any interval after baseline in the absence of a known exposure or ongoing transmission; 4) encouragement of treatment for all health care personnel with untreated LTBI, unless treatment is contraindicated; 5) annual symptom screening for health care personnel with untreated LTBI; and 6) annual TB education of all health care personnel. |
Update of recommendations for use of once-weekly isoniazid-rifapentine regimen to treat latent Mycobacterium tuberculosis infection
Borisov AS , Bamrah Morris S , Njie GJ , Winston CA , Burton D , Goldberg S , Yelk Woodruff R , Allen L , LoBue P , Vernon A . MMWR Morb Mortal Wkly Rep 2018 67 (25) 723-726 Treatment of latent tuberculosis infection (LTBI) is critical to the control and elimination of tuberculosis disease (TB) in the United States. In 2011, CDC recommended a short-course combination regimen of once-weekly isoniazid and rifapentine for 12 weeks (3HP) by directly observed therapy (DOT) for treatment of LTBI, with limitations for use in children aged <12 years and persons with human immunodeficiency virus (HIV) infection (1). CDC identified the use of 3HP in those populations, as well as self-administration of the 3HP regimen, as areas to address in updated recommendations. In 2017, a CDC Work Group conducted a systematic review and meta-analyses of the 3HP regimen using methods adapted from the Guide to Community Preventive Services. In total, 19 articles representing 15 unique studies were included in the meta-analysis, which determined that 3HP is as safe and effective as other recommended LTBI regimens and achieves substantially higher treatment completion rates. In July 2017, the Work Group presented the meta-analysis findings to a group of TB experts, and in December 2017, CDC solicited input from the Advisory Council for the Elimination of Tuberculosis (ACET) and members of the public for incorporation into the final recommendations. CDC continues to recommend 3HP for treatment of LTBI in adults and now recommends use of 3HP 1) in persons with LTBI aged 2-17 years; 2) in persons with LTBI who have HIV infection, including acquired immunodeficiency syndrome (AIDS), and are taking antiretroviral medications with acceptable drug-drug interactions with rifapentine; and 3) by DOT or self-administered therapy (SAT) in persons aged >/=2 years. |
Isoniazid-rifapentine for latent tuberculosis infection: A systematic review and meta-analysis
Njie GJ , Morris SB , Woodruff RY , Moro RN , Vernon AA , Borisov AS . Am J Prev Med 2018 55 (2) 244-252 CONTEXT: Latent tuberculosis infection diagnosis and treatment is a strategic priority for eliminating tuberculosis in the U.S. The Centers for Disease Control and Prevention has recommended the short-course regimen of 3-month isoniazid-rifapentine administered by directly observed therapy. However, longer-duration regimens remain the most widely prescribed latent tuberculosis infection treatments. Limitation on adoption of 3-month isoniazid-rifapentine in the U.S. might be because of patients' preference for self-administered therapy, providers' lack of familiarity with 3-month isoniazid-rifapentine, or lack of resources to support directly observed therapy. This review examines the most recent evidence regarding 3-month isoniazid-rifapentine's effectiveness, safety, and treatment completion when directly compared with other latent tuberculosis infection regimens primarily comprising 9-month isoniazid treatment. EVIDENCE ACQUISITION: Using Community Guide methodology, reviewers identified, evaluated, and summarized available evidence published during January 2006-June 2017. Analysis of the data was completed in 2017. EVIDENCE SYNTHESIS: The analysis included 15 unique studies. Three-month isoniazid-rifapentine was determined to be equal to other latent tuberculosis infection regimens in effectiveness (OR=0.89, 95% CI=0.46, 1.70), and has higher treatment completion (87.5%, 95% CI=83.2%, 91.3%) compared with other latent tuberculosis infection regimens (65.9%, 95% CI=53.5%, 77.3%). Three-month isoniazid-rifapentine was associated with similar risk to other latent tuberculosis infection regimens for adverse events (relative risk=0.59, 95% CI=0.23, 1.52); discontinuing treatment because of adverse events (relative risk=0.48, 95% CI=0.17, 1.34); and death (relative risk=0.79, 95% CI=0.56, 1.11). CONCLUSIONS: The 3-month isoniazid-rifapentine regimen is as safe and effective as other recommended latent tuberculosis infection regimens and achieves significantly higher treatment completion rates. |
Universal motorcycle helmet laws to reduce injuries: A Community Guide Systematic Review
Peng Y , Vaidya N , Finnie R , Reynolds J , Dumitru C , Njie G , Elder R , Ivers R , Sakashita C , Shults RA , Sleet DA , Compton RP . Am J Prev Med 2017 52 (6) 820-832 CONTEXT: Motorcycle crashes account for a disproportionate number of motor vehicle deaths and injuries in the U.S. Motorcycle helmet use can lead to an estimated 42% reduction in risk for fatal injuries and a 69% reduction in risk for head injuries. However, helmet use in the U.S. has been declining and was at 60% in 2013. The current review examines the effectiveness of motorcycle helmet laws in increasing helmet use and reducing motorcycle-related deaths and injuries. EVIDENCE ACQUISITION: Databases relevant to health or transportation were searched from database inception to August 2012. Reference lists of reviews, reports, and gray literature were also searched. Analysis of the data was completed in 2014. EVIDENCE SYNTHESIS: A total of 60 U.S. studies qualified for inclusion in the review. Implementing universal helmet laws increased helmet use (median, 47 percentage points); reduced total deaths (median, -32%) and deaths per registered motorcycle (median, -29%); and reduced total injuries (median, -32%) and injuries per registered motorcycle (median, -24%). Repealing universal helmet laws decreased helmet use (median, -39 percentage points); increased total deaths (median, 42%) and deaths per registered motorcycle (median, 24%); and increased total injuries (median, 41%) and injuries per registered motorcycle (median, 8%). CONCLUSIONS: Universal helmet laws are effective in increasing motorcycle helmet use and reducing deaths and injuries. These laws are effective for motorcyclists of all ages, including younger operators and passengers who would have already been covered by partial helmet laws. Repealing universal helmet laws decreased helmet use and increased deaths and injuries. |
Cost and economic benefit of clinical decision support systems for cardiovascular disease prevention: a Community Guide systematic review
Jacob V , Thota AB , Chattopadhyay SK , Njie GJ , Proia KK , Hopkins DP , Ross MN , Pronk NP , Clymer JM . J Am Med Inform Assoc 2017 24 (3) 669-676 OBJECTIVE: This review evaluates costs and benefits associated with acquiring, implementing, and operating clinical decision support systems (CDSSs) to prevent cardiovascular disease (CVD). MATERIALS AND METHODS: Methods developed for the Community Guide were used to review CDSS literature covering the period from January 1976 to October 2015. Twenty-one studies were identified for inclusion. RESULTS: It was difficult to draw a meaningful estimate for the cost of acquiring and operating CDSSs to prevent CVD from the available studies (n = 12) due to considerable heterogeneity. Several studies (n = 11) indicated that health care costs were averted by using CDSSs but many were partial assessments that did not consider all components of health care. Four cost-benefit studies reached conflicting conclusions about the net benefit of CDSSs based on incomplete assessments of costs and benefits. Three cost-utility studies indicated inconsistent conclusions regarding cost-effectiveness based on a conservative $50,000 threshold. DISCUSSION: Intervention costs were not negligible, but specific estimates were not derived because of the heterogeneity of implementation and reporting metrics. Expected economic benefits from averted health care cost could not be determined with confidence because many studies did not fully account for all components of health care. CONCLUSION: We were unable to conclude whether CDSSs for CVD prevention is either cost-beneficial or cost-effective. Several evidence gaps are identified, most prominently a lack of information about major drivers of cost and benefit, a lack of standard metrics for the cost of CDSSs, and not allowing for useful life of a CDSS that generally extends beyond one accounting period. |
Reducing medication costs to prevent cardiovascular disease: A Community Guide Systematic Review
Njie GJ , Finnie RK , Acharya SD , Jacob V , Proia KK , Hopkins DP , Pronk NP , Goetzel RZ , Kottke TE , Rask KJ , Lackland DT , Braun LT . Prev Chronic Dis 2015 12 E208 INTRODUCTION: Hypertension and hyperlipidemia are major cardiovascular disease risk factors. To modify them, patients often need to adopt healthier lifestyles and adhere to prescribed medications. However, patients' adherence to recommended treatments has been suboptimal. Reducing out-of-pocket costs (ROPC) to patients may improve medication adherence and consequently improve health outcomes. This Community Guide systematic review examined the effectiveness of ROPC for medications prescribed for patients with hypertension and hyperlipidemia. METHODS: We assessed effectiveness and economics of ROPC for medications to treat hypertension, hyperlipidemia, or both. Per Community Guide review methods, reviewers identified, evaluated, and summarized available evidence published from January 1980 through July 2015. RESULTS: Eighteen studies were included in the analysis. ROPC interventions resulted in increased medication adherence for patients taking blood pressure and cholesterol medications by a median of 3.0 percentage points; proportion achieving 80% adherence to medication increased by 5.1 percentage points. Blood pressure and cholesterol outcomes also improved. Nine studies were included in the economic review, with a median intervention cost of $172 per person per year and a median change in health care cost of -$127 per person per year. CONCLUSION: ROPC for medications to treat hypertension and hyperlipidemia is effective in increasing medication adherence, and, thus, improving blood pressure and cholesterol outcomes. Most ROPC interventions are implemented in combination with evidence-based health care interventions such as team-based care with medication counseling. An overall conclusion about the economics of the intervention could not be reached with the small body of inconsistent cost-benefit evidence. |
The role of clinical decision support systems in preventing cardiovascular disease
Wall HK , Wright JS . Am J Prev Med 2015 49 (5) e83-4 Based on evidence from the Njie et al.1 systematic review, the Community Preventive Services Task Force recommends clinical decision support systems (CDSS) due to sufficient evidence of effectiveness to improve cardiovascular disease (CVD) risk factor screening and practices for CVD-related preventive care services, clinical tests, and treatments; however, evidence was lacking for effectiveness to improve CVD risk factor outcomes from several studies with inconsistent conclusions.2 These findings are particularly important in the current national atmosphere that encourages clinicians to use electronic health records (EHRs) and the health information technology (IT) capacity within those systems, including clinical decision supports, to meaningfully improve the quality of delivered care, reduce costs, and improve population health management practices.3 Effective CDSS are, most often, computerized information systems that use knowledge bases and patient information at the point of care to drive evidence-based treatment. They can provide the right information to the right people, both clinicians and patients, in the right format (e.g., alerts, order sets, protocols, info buttons) through the right channels (e.g., via an EHR, a smartphone app, or computerized physician order entry) at the right time in the clinical workflow.4 These recommendations from the Community Preventive Services Task Force are important in moving the needle on CVD prevention. | Each year, there are 1.5 million heart attacks and strokes,5 major contributors to CVD, the leading cause of death in the U.S. One in three deaths is attributable to CVD, representing almost 800,000 annual deaths, many of which are avoidable.6,7 To address the burden of CVD, in 2012, the U.S. DHHS launched Million Hearts®, a national initiative, co-led by CDC and the Centers for Medicare & Medicaid Services, with the goal of preventing one million heart attacks and strokes by 2017 by implementing proven interventions in clinical settings and communities. |
Economics of team-based care in controlling blood pressure: a Community Guide systematic review
Jacob V , Chattopadhyay SK , Thota AB , Proia KK , Njie G , Hopkins DP , Finnie RK , Pronk NP , Kottke TE . Am J Prev Med 2015 49 (5) 772-83 CONTEXT: High blood pressure is an important risk factor for cardiovascular disease and stroke, the leading cause of death in the U.S., and a substantial national burden through lost productivity and medical care. A recent Community Guide systematic review found strong evidence of effectiveness of team-based care in improving blood pressure control. The objective of the present review is to determine from the economic literature whether team-based care for blood pressure control is cost beneficial or cost effective. EVIDENCE ACQUISITION: Electronic databases of papers published January 1980-May 2012 were searched to find economic evaluations of team-based care interventions to improve blood pressure outcomes, yielding 31 studies for inclusion. EVIDENCE SYNTHESIS: In analyses conducted in 2012, intervention cost, healthcare cost averted, benefit-to-cost ratios, and cost effectiveness were abstracted from the studies. The quality of estimates for intervention and healthcare cost from each study were assessed using three elements: intervention focus on blood pressure control, incremental estimates in the intervention group relative to a control group, and inclusion of major cost-driving elements in estimates. Intervention cost per unit reduction in systolic blood pressure was converted to lifetime intervention cost per quality-adjusted life-year (QALY) saved using algorithms from published trials. CONCLUSIONS: Team-based care to improve blood pressure control is cost effective based on evidence that 26 of 28 estimates of $/QALY gained from ten studies were below a conservative threshold of $50,000. This finding is salient to recent U.S. healthcare reforms and coordinated patient-centered care through formation of Accountable Care Organizations. |
Clinical decision support systems and prevention: a Community Guide Cardiovascular Disease Systematic Review
Njie GJ , Proia KK , Thota AB , Finnie RK , Hopkins DP , Banks SM , Callahan DB , Pronk NP , Rask KJ , Lackland DT , Kottke TE . Am J Prev Med 2015 49 (5) 784-95 CONTEXT: Clinical decision support systems (CDSSs) can help clinicians assess cardiovascular disease (CVD) risk and manage CVD risk factors by providing tailored assessments and treatment recommendations based on individual patient data. The goal of this systematic review was to examine the effectiveness of CDSSs in improving screening for CVD risk factors, practices for CVD-related preventive care services such as clinical tests and prescribed treatments, and management of CVD risk factors. EVIDENCE ACQUISITION: An existing systematic review (search period, January 1975-January 2011) of CDSSs for any condition was initially identified. Studies of CDSSs that focused on CVD prevention in that review were combined with studies identified through an updated search (January 2011-October 2012). Data analysis was conducted in 2013. EVIDENCE SYNTHESIS: A total of 45 studies qualified for inclusion in the review. Improvements were seen for recommended screening and other preventive care services completed by clinicians, recommended clinical tests completed by clinicians, and recommended treatments prescribed by clinicians (median increases of 3.8, 4.0, and 2.0 percentage points, respectively). Results were inconsistent for changes in CVD risk factors such as systolic and diastolic blood pressure, total and low-density lipoprotein cholesterol, and hemoglobin A1C levels. CONCLUSIONS: CDSSs are effective in improving clinician practices related to screening and other preventive care services, clinical tests, and treatments. However, more evidence is needed from implementation of CDSSs within the broad context of comprehensive service delivery aimed at reducing CVD risk and CVD-related morbidity and mortality. |
Absence of putative artemisinin resistance mutations among Plasmodium falciparum in Sub-Saharan Africa: a molecular epidemiologic study.
Taylor SM , Parobek CM , DeConti DK , Kayentao K , Coulibaly SO , Greenwood BM , Tagbor H , Williams J , Bojang K , Njie F , Desai M , Kariuki S , Gutman J , Mathanga DP , Mårtensson A , Ngasala B , Conrad MD , Rosenthal PJ , Tshefu AK , Moormann AM , Vulule JM , Doumbo OK , Ter Kuile FO , Meshnick SR , Bailey JA , Juliano JJ . J Infect Dis 2014 211 (5) 680-8 Plasmodium falciparum parasites that are resistant to artemisinins have been detected in Southeast Asia. Resistance is associated with several polymorphisms in the parasite's K13-propeller gene. The molecular epidemiology of these artemisinin-resistant genotypes in African parasite populations is unknown. We developed an assay to quantify rare polymorphisms in parasite populations using a pooled deep-sequencing approach to score allele frequencies, validated it using mixtures of laboratory parasite strains, and then employed it to screen over 1,100 African P. falciparum infections collected since 2002 from 14 sites across sub-Saharan Africa. We found no mutations in African parasite populations that are associated with artemisinin resistance in Southeast Asian parasites. However, we observed 15 coding mutations, including 12 novel mutations, and limited allele sharing between parasite populations, consistent with a large reservoir of naturally-occurring K13-propeller variation. Though polymorphisms associated with artemisinin resistance in P. falciparum in Southeast Asia are not prevalent in sub-Saharan Africa, numerous K13-propeller coding polymorphisms circulate in Africa. Although their distributions do not support a widespread selective sweep for an artemisinin resistant phenotype, the impact of these mutations on artemisinin susceptibility is unknown and will require further characterization. Rapid, scalable molecular surveillance offers a useful adjunct in tracking and containing artemisinin resistance. |
Team-based care and improved blood pressure control: a Community Guide systematic review
Proia KK , Thota AB , Njie GJ , Finnie RK , Hopkins DP , Mukhtar Q , Pronk NP , Zeigler D , Kottke TE , Rask KJ , Lackland DT , Brooks JF , Braun LT , Cooksey T . Am J Prev Med 2014 47 (1) 86-99 CONTEXT: Uncontrolled hypertension remains a widely prevalent cardiovascular risk factor in the U.S. team-based care, established by adding new staff or changing the roles of existing staff such as nurses and pharmacists to work with a primary care provider and the patient. Team-based care has the potential to improve the quality of hypertension management. The goal of this Community Guide systematic review was to examine the effectiveness of team-based care in improving blood pressure (BP) outcomes. EVIDENCE ACQUISITION: An existing systematic review (search period, January 1980-July 2003) assessing team-based care for BP control was supplemented with a Community Guide update (January 2003-May 2012). For the Community Guide update, two reviewers independently abstracted data and assessed quality of eligible studies. EVIDENCE SYNTHESIS: Twenty-eight studies in the prior review (1980-2003) and an additional 52 studies from the Community Guide update (2003-2012) qualified for inclusion. Results from both bodies of evidence suggest that team-based care is effective in improving BP outcomes. From the update, the proportion of patients with controlled BP improved (median increase=12 percentage points); systolic BP decreased (median reduction=5.4 mmHg); and diastolic BP also decreased (median reduction=1.8 mmHg). CONCLUSIONS: Team-based care increased the proportion of people with controlled BP and reduced both systolic and diastolic BP, especially when pharmacists and nurses were part of the team. Findings are applicable to a range of U.S. settings and population groups. Implementation of this multidisciplinary approach will require health system-level organizational changes and could be an important element of the medical home. |
A Quality Control Program within a Clinical Trial Consortium for PCR Protocols To Detect Plasmodium Species
Taylor SM , Mayor A , Mombo-Ngoma G , Kenguele HM , Ouedraogo S , Ndam NT , Mkali H , Mwangoka G , Valecha N , Singh JP , Clark MA , Verweij JJ , Adegnika AA , Severini C , Menegon M , Macete E , Menendez C , Cistero P , Njie F , Affara M , Otieno K , Kariuki S , Ter Kuile FO , Meshnick SR . J Clin Microbiol 2014 52 (6) 2144-9 Malaria parasite infections that are only detectable by molecular methods are highly prevalent and represent a potential transmission reservoir. The methods used to detect these infections are not standardized, and their operating characteristics are often unknown. We designed a proficiency panel of Plasmodium spp. in order to compare the accuracy of parasite detection of molecular protocols used by labs in a clinical trial consortium. Ten dried blood spots (DBSs) were assembled that contained P. falciparum, P. vivax, P. malariae, and P. ovale; DBSs contained either a single species or a species mixed with P. falciparum. DBS panels were tested in 9 participating laboratories in a masked fashion. Of 90 tests, 68 (75.6%) were correct; there were 20 false-negative results and 2 false positives. The detection rate was 77.8% (49/63) for P. falciparum, 91.7% (11/12) for P. vivax, 83.3% (10/12) for P. malariae, and 70% (7/10) for P. ovale. Most false-negative P. falciparum results were from samples with an estimated ≤5 parasites per mul of blood. Between labs, accuracy ranged from 100% to 50%. In one lab, the inability to detect species in mixed-species infections prompted a redesign and improvement of the assay. Most PCR-based protocols were able to detect P. falciparum and P. vivax at higher densities, but these assays may not reliably detect parasites in samples with low P. falciparum densities. Accordingly, formal quality assurance for PCR should be employed whenever this method is used for diagnosis or surveillance. Such efforts will be important if PCR is to be widely employed to assist malaria elimination efforts. |
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