Fogarty International Clinical Research Articles

Anicteric Leptospirosis-Associated Meningitis in a Tropical Urban Environment, Brazil.

While studying aseptic meningitis in Salvador, Brazil, we diagnosed anicteric leptospirosis in 1.7% (5/295) of patients hospitalized for aseptic meningitis. Leptospirosis-associated meningitis patients had lower mean cerebrospinal fluid cell counts and protein than other-cause aseptic meningitis (p<0.05). Clinicians must consider leptospirosis-associated meningitis in appropriate clinical-epidemiologic contexts.

Impact of International Collaborative Training Programs on Medical Students' Research Ability.

International collaborative training programs for graduate students are widespread, but studies on their educational impact are limited. As an advanced cancer institute in China, Cancer Hospital Chinese Academy of Medical Science (CHCAMS) attaches great importance to international exchanges and cooperation within graduate education. The Department of Epidemiology of CHCAMS has been involved in several existing international training programs and has also launched a short-term training program in cooperation with foreign universities and institutes from 2008. Fogarty International Clinical Research Scholars and Fellows (FICRS-F) Program and the Fulbright-Fogarty Fellowship Program are the most typical examples of our practice in international cooperation on graduate education over these years. Our department has gained substantial experience in graduate-level international collaborative training, focused on cancer epidemiology. This paper is a brief introduction to the practice of different programs in our department and students' achievements during and after training. Moreover, we attempt to serve as a reference and help promote the training of graduate students pursuing careers in cancer research or global health by other universities or research institutes.

Impact of Global Health Research Training on Scholarly Productivity: The Fogarty International Clinical Research Scholars and Fellows Program.

In the Fogarty International Clinical Research Scholars and Fellows (FICRS-F) Program, 536 U.S. and international doctoral and postdoctoral health profession students and trainees completed 1-year research training at research centers in low- and middle-income countries. To evaluate the Program's impact, we analyzed data gathered prospectively during the Program, from PubMed, and from a representative survey of alumni. Of 100 randomly selected respondents, 94 returned the survey. Reflecting the sources of funding, human immunodeficiency virus/acquired immunodeficiency syndrome was the focus of 47% of the projects, but research in noncommunicable diseases (NCDs) and dual infection/NCD-related topics increased over time. Among the first 1,617 alumni publications, output was associated positively with being an international versus U.S. trainee, a postdoctoral Fellow versus predoctoral Scholar, and accumulation of more years post-training (all P < 0.001). Fellows were first author on a higher proportion of their articles than were Scholars (P < 0.001), and U.S. trainees were more often first author than international trainees (P = 0.04). Survey respondents had submitted 117 grant applications, and 79 (67.5%) had been funded. The FICRS-F Program yielded substantial research productivity in the early post-training years. Research outputs and impact will increase over time as alumni careers mature and they gain research independence and assume leadership positions.

Impact of Global Health Research Training on Career Trajectories: The Fogarty International Clinical Research Scholars and Fellows Program.

From 2004 to 2012, the Fogarty International Clinical Research Scholars/Fellows Program (FICRS-F) provided 1-year research training opportunities for U.S. and international doctoral "Scholars" and postdoctoral "Fellows" at low- and middle-income country (LMIC) centers. We collected data prospectively and then surveyed a representative sample of 100 alumni (94% response), assessing Program impacts on their careers and collaborations. Frequently, collaborations continued beyond the formal training period with U.S.- (63%) and site-based mentors (66%). U.S. Fellows reported the highest post-training focus on research (88 on a 100-point scale), and the highest Program impact on competitiveness for career or training positions and choices of post-training topics and institutions (95 points). Interest in global health research increased markedly during the training period, especially for LMIC trainees, and was sustained post-training. LMIC alumni reported a significantly higher focus on global health and research than did U.S. alumni. Alumni reported that their mentored research training had a substantial impact on their career trajectories.

Outcomes and collaborations among alumni of the NIH Fogarty International Clinical Research Program: Results from a 2013 impact evaluation

Outcomes and collaborations among alumni of the NIH Fogarty International Clinical Research Program: Results from a 2013 impact evaluation

Impact of the NIH Fogarty International Clinical Research Program on trainees' career trajectories: Results from a 2013 impact evaluation

Impact of the NIH Fogarty International Clinical Research Program on trainees' career trajectories: Results from a 2013 impact evaluation

Global health research in narrative: a qualitative look at the FICRS-F experience.

For American professional and graduate health sciences trainees, a mentored fellowship in a low- or middle-income country (LMIC) can be a transformative experience of personal growth and scientific discovery. We invited 86 American trainees in the Fogarty International Clinical Research Scholars and Fellows Program and Fulbright-Fogarty Fellowship 2011-2012 cohorts to contribute personal essays about formative experiences from their fellowships. Nine trainees contributed essays that were analyzed using an inductive approach. The most frequently addressed themes were the strong continuity of research and infrastructure at Fogarty fellowship sites, the time-limited nature of this international fellowship experience, and the ways in which this fellowship period was important for shaping future career planning. Trainees also addressed interaction with host communities vis-à-vis engagement in project implementation. These qualitative essays have contributed insights on how a 1-year mentored LMIC-based research training experience can influence professional development, complementing conventional evaluations. Full text of the essays is available at http://fogartyscholars.org/.

Recruiting post-doctoral fellows into global health research: selecting NIH Fogarty International Clinical Research Fellows.

From 2008 to 2012, the National Institutes of Health (NIH) Fogarty International Clinical Research Fellows Program (FICRF) provided 1-year mentored research training at low- and middle-income country sites for American and international post-doctoral health professionals. We examined the FICRF applicant pool, proposed research topics, selection process, and characteristics of enrollees to assess trends in global health research interest and factors associated with applicant competitiveness. The majority (58%) of 67 US and 57 international Fellows were women, and 83% of Fellows had medical degrees. Most applicants were in clinical fellowships (41%) or residencies (24%). More applicants proposing infectious disease projects were supported (59%) than applicants proposing non-communicable disease (NCD) projects (41%), although projects that combined both topic areas were most successful (69%). The numbers of applicants proposing research on NCDs and the numbers of these applicants awarded fellowships rose dramatically over time. Funding provided to the FICRF varied significantly among NIH Institutes and Centers and was strongly associated with the research topics awarded.

The psychological toll of slum living—an assessment of mental health, disability, and slum-related adversities in Mumbai, India

Abstract Background Few studies have examined mental health in developing country slums. We ascertain the prevalence of common mental disorders in adults and identify slum-related stressors associated with risk of common mental disorders in a slum of 14 000 people in Mumbai, India. Methods Participants were selected with random sampling. We completed 521 interviews during February, 2012; the non-response rate was 9%. We administered the General Health Questionnaire-12 (GHQ) to screen for common mental disorders, the WHO Disability Assesment Schedule 2.0 to screen for disability, and a slum stressor questionnaire. Logistic regression was used to identify predictors of having a common mental disorder. Linear regression was used to assess the contribution of GHQ score and physical impairments to disability (ie, WHO Disability Assesment Schedule 2.0). Findings 121 (23%) of 521 individuals had a GHQ score of 5 or more (ie, high risk of common mental disorder). Factors associated with a GHQ score of 5 or more in the multivariate logistic regression model (R2=0·32, n=502) include age older than 45 years, having a loan, food insecurity, sleeping sitting up or outside because of overcrowding, being affected by rats, and paying a high price for water. 5–9 years of education and an income greater than 3000 rupees per month are protective against common mental disorders. In linear regression analyses, 22% of variation in the WHO Disability Assesment Schedule score is explained by GHQ score; only 19% is explained by physical impairments. Interpretation This slum's burden of common mental disorders exceeds that for all other population-based Indian studies. Psychological distress contributes greatly to the disability burden of the slum. Interventions to address slum-related stressors and poverty might help to alleviate the high burden of mental illness and disability in slums. Funding The Fogarty International Clinical Research Fellows Program at Vanderbilt (R24 TW007988), Harvard T32 post-doctoral clinical research fellowship (NIAID AI 007433), the Eunice Kennedy Shriver National Institute for Child Health and Human Development (5R24HD047879), the National Institutes of Health (5T32HD007163), the Rockefeller Foundation, and the Weatherhead Center for International Affairs at Harvard University.

Training Programs Within Global Networks: Lessons Learned in the Fogarty International Clinical Research Scholars and Fellows Program

The Fogarty International Clinical Research Scholars and Fellows Support Center at Vanderbilt describes administrative lessons learned from the management of 436 scholars (American students or host country junior trainees) and 122 post-doctoral fellows (Americans or host country nationals). Trainees spent 10-11 months working on mentored research projects at 61 well-vetted sites in 27 low- or middle-income host countries (LMICs) with strong US partners. Economies of scale, strong centralized information exchange, and effective standardized operations linking US institutions with LMIC field sites were achieved in a program that minimized administrative overhead. Advantages and drawbacks of this approach are presented and discussed. Training of a new generation of global research leaders is greatly facilitated by an overseas mentored research experience that is administratively streamlined to optimize the use of resources for training, research, and capacity building.

Recruiting Trainees for a Global Health Research Workforce: The National Institutes of Health Fogarty International Clinical Research Scholars Program Selection Process

Between 2004 and 2012, the National Institutes of Health Fogarty International Clinical Research Scholars (FICRS) Program provided 1-year mentored research training at low- and middle-income country sites for American and international health science doctoral students. We describe the centralized application process, US applicant characteristics, and predictors of selection/enrollment. FICRS received 1,084 applicants representing many health professions and biomedical disciplines at 132 US academic institutions; 219 students from 72 institutions were accepted and enrolled. Medical/osteopathic students comprised 88.9% of applicants and 85.8% of enrollees. Applicants from institutions with higher applicant numbers were two times as likely to be selected. In 2012, FICRS was decentralized among 20 institutions in five consortia (Global Health Fellows), with autonomous selection processes that emphasize post-doctoral trainees. If academia, government, or charitable foundations offer future opportunities to health professions students for international research, the FICRS experience predicts that they can attract substantial numbers of motivated trainees from diverse backgrounds.

Medical Students’ Experiences With Authorship in Biomedical Research

To explore authorship issues related to medical students' primary research projects, assess medical students' knowledge about authorship issues in biomedical research, and determine their interest in learning about authorship guidelines. In 2011, the authors developed and conducted an electronic survey of 243 U.S. medical students who attended an educational event at the National Institutes of Health as part of their funded, yearlong research fellowship programs. The authors then analyzed the results using descriptive statistics. Of 243 students, 152 (63%) responded. Most (120/151; 79%) had completed or were in the process of writing a manuscript based on their projects. Of these, most (95/119; 80%) wrote the entire manuscript independently or with guidance. Whereas almost two-thirds (99/152; 65%) indicated that expectations and criteria for authorship were clarified for them, 26% (40/152) indicated that they were not. Most students (108/118; 92%) were in the authorship position they expected and had no concerns about who the other authors were (91/119; 77%). Of those with concerns, 52% (11/21) did not raise the issue for fear of challenging their mentor. Two-thirds (95/145; 66%) never received formal training in authorship guidelines, and 41% (42/103) believed such training would be valuable. Although a majority of students had conversations about authorship and were clear about the guidelines for ethical authorship, additional work is needed. The authors recommend that academic institutions develop a menu of options for teaching students about this important area in research ethics.

The impact of routine cryptococcal antigen screening on survival among HIV‐infected individuals with advanced immunosuppression in Kenya

To test the hypothesis that a screening and treatment intervention for early cryptococcal infection would improve survival among HIV-infected individuals with low CD4 cell counts. Newly enrolled patients at Family AIDS Care and Education Services (FACES) in Kenya with CD4≤100 cells/μl were tested for serum cryptococcal antigen (sCrAg). Individuals with sCrAg titre≥1:2 were treated with high-dose fluconazole. Cox proportional hazard models of Kaplan-Meier curves were used to compare survival among individuals with CD4≤100 cells/μl in the intervention and historical control groups. The median age was 34years [IQR: 29,41], 54% were female, and median CD4 was 43 cells/μl [IQR: 18,71]. Follow-up time was 1224 person-years. In the intervention group, 66% (514/782) were tested for sCrAg; of whom, 11% (59/514) were sCrAg positive. Mortality was 25% (196/782) in the intervention group and 25% (191/771) in the control group. There was no significant difference between the intervention and control group in overall survival [hazard ratio (HR): 1.1 (95%CI:0.9,1.3)] or three-month survival [HR: 1.0 (95%CI:0.8,1.3)]. Within the intervention group, sCrAg-positive individuals had significantly lower survival rates than sCrAg-negative individuals [HR:1.8 (95%CI: 1.0, 3.0)]. A screening and treatment intervention to identify sCrAg-positive individuals and treat them with high-dose fluconazole did not significantly improve overall survival among HIV-infected individuals with CD4 counts≤100 cells/μl compared to a historical control, perhaps due to intervention uptake rates or poor efficacy of high-dose oral fluconazole.

Nurturing the Global Workforce in Clinical Research: The National Institutes of Health Fogarty International Clinical Scholars and Fellows Program

The Fogarty International Clinical Research Scholars and Fellows Program's goal is to foster the next generation of clinical investigators and to help build international health research partnerships between American and international investigators and institutions. Through June 2012, 61 sites in 27 countries have hosted 436 Scholars (American students or junior trainees from the host countries) and/or 122 Fellows (American and host country postdoctoral fellows) for year-long experiences in global health research. Initially, the program was oriented toward infectious diseases, but recently emphasis on chronic disease research has increased. At least 521 manuscripts have been published, many in high-impact journals. Projects have included clinical trials, observational studies, translational research, clinical-laboratory interface initiatives, and behavioral research. Strengths of the program include training opportunities for American and developing country scientists in well-established international clinical research settings, and mentorship from experienced global health experts.

Performance of high-risk human papillomavirus DNA testing as a primary screen for cervical cancer: a pooled analysis of individual patient data from 17 population-based studies from China

Controversy remains over whether high-risk human papillomavirus (HPV) DNA testing should be used as a primary screen for cervical cancer. The aims of our study were to assess whether HPV DNA testing could be applied to cervical-cancer screening programmes in China, as well as other similar developing countries. We did a pooled analysis of population-based cervical cancer screening studies done in mainland China from 1999 to 2008 with concurrent HPV DNA testing (Hybrid Capture 2 assay; Qiagen, Gaithersburg, MD, USA), liquid-based cytology (LBC), and visual inspection with acetic acid (VIA). Eligible women were sexually active, not pregnant, had an intact uterus, and had no history of cervical intraepithelial neoplasia (CIN), cervical cancer, or pelvic irradiation. All women positive for any test were referred for colposcopy and biopsy. Cervical lesions were diagnosed by directed or random biopsy. We assessed the diagnostic accuracy of HPV DNA testing for the detection of CIN grade 3 or greater. 30,371 women from 17 cross-sectional, population-based studies in various parts of China were screened. 1523 women were subsequently excluded because of inadequate HPV DNA specimens or they did not have a biopsy taken, which included women with atypical squamous cells of undetermined significance; low-grade squamous intraepithelial lesion or worse; positive HPV, negative cytology, and missing or positive colposcopy results; and unsatisfactory cytology results. HPV DNA testing had a higher sensitivity of 97·5% (95% CI 95·7-98·7) for detection of CIN grade 3 or worse, and a lower specificity of 85·1% (82·3-87·9), compared with cytology (sensitivity 87·9% [95% CI 84·7-90·7], specificity 94·7% [93·5-96·0]) and VIA (54·6% [48·0-61·2], 89·9% [86·8-93·0]). Sensitivity did not vary by study or age (<35 years, 35-49 years, ≥50 years); however, specificity did vary with age (p<0·0001) and was highest in women younger than 35 years (89·4%; 95% CI 86·1-91·5). An increase in the positive cutoff point from the manufacturer recommended 1 pg/mL to 2 pg/mL led to a decrease in the overall HPV DNA positivity from 16·3% to 13·9% (p<0·0001), which could result in a decrease in referral rates, although sensitivity was slightly lower (97·5% to 95·2%). An increase in the cutoff point to 10 pg/mL in women younger than 35 years maintained a high sensitivity 97·7% (95% CI 87·7-99·9) and increased specificity to 93·5% (95% CI 91·9-94·6). HPV DNA testing is highly sensitive and moderately specific for CIN grade 3 or worse, with consistent results across study sites and age groups-including women younger than 35 years. A rise in the cutoff point might be beneficial for future screening programmes in China, especially when screening women younger than 35 years.

Global chronic disease research training for fellows: perspectives, challenges, and opportunities.

The growing interest in global chronic disease research is not matched by workforce capacity at present.1 The dearth of researchers with global chronic disease backgrounds and training has led to the creation of novel funding opportunities for young researchers, particularly fellows. As 2 cardiology fellows in global cardiovascular disease research training through the US National Institutes of Health (NIH) Fogarty International Clinical Research Fellows’ (FICR-F) program, we have a unique perspective on the challenges and opportunities in this area. Here, we present our perspective on potential funding pathways, areas of interest germane to global cardiovascular disease research, the importance of an overseas training component, forms of “home” institutional support that can be helpful, and personal challenges and opportunities that merit consideration. Global chronic disease research has garnered attention recently with several widely publicized reports describing its scope and importance.1–3 The creation of the Millennium Development Goals (MDGs) by the United Nations in 2000 led to a groundswell of interest in pursuing data-driven research and goal-directed programs toward global development.4 Three of the MDGs have direct health targets: reduce child mortality; improve maternal health; and combat HIV/AIDS, malaria, and other diseases. The other MDGs have indirect effects on health through development. Since the creation and subsequent adoption of the MDGs by various global government, nongovernment, and research organizations, some have argued for the specific inclusion of chronic diseases in the MDGs, given their prevalence.5 Publications from the World Health Organization, the Global Alliance for Chronic Disease, the Institute of Medicine, and the National Heart, Lung, and Blood Institute (NHLBI) have outlined the rationale for such global health research, particularly in chronic diseases.1,6–8 These organizations argue that global chronic disease research has the potential to blunt the economic impact of an unchecked epidemic of chronic diseases.3,9 …