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Ioannidis J.P.A.,Stanford University | Greenland S.,University of California at Los Angeles | Hlatky M.A.,Stanford University | Khoury M.J.,Centers for Disease Control and Prevention | And 6 more authors.
The Lancet | Year: 2014

Correctable weaknesses in the design, conduct, and analysis of biomedical and public health research studies can produce misleading results and waste valuable resources. Small eff ects can be diffi cult to distinguish from bias introduced by study design and analyses. An absence of detailed written protocols and poor documentation of research is common. Information obtained might not be useful or important, and statistical precision or power is often too low or used in a misleading way. Insuffi cient consideration might be given to both previous and continuing studies. Arbitrary choice of analyses and an overemphasis on random extremes might aff ect the reported fi ndings. Several problems relate to the research workforce, including failure to involve experienced statisticians and methodologists, failure to train clinical researchers and laboratory scientists in research methods and design, and the involvement of stakeholders with confl icts of interest. Inadequate emphasis is placed on recording of research decisions and on reproducibility of research. Finally, reward systems incentivise quantity more than quality, and novelty more than reliability. We propose potential solutions for these problems, including improvements in protocols and documentation, consideration of evidence from studies in progress, standardisation of research eff orts, optimisation and training of an experienced and non-confl icted scientifi c workforce, and reconsideration of scientific reward systems.

Aral S.O.,Centers for Disease Control and Prevention | Cates Jr. W.,FHI 360
Sexually Transmitted Infections | Year: 2013

Development of efficacious interventions is only the first step in achieving population level impact. Efficacious interventions impact infection levels in the population only if they are implemented at the right scale. Coverage must be prioritised across subpopulations based on the diversity and clustering of infections and risk in society, and expanded rapidly without delay. It is important to prioritise those who are most likely to transmit infection first.

Van Der Straten A.,University of California at San Francisco | Van Damme L.,FHI 360 | Haberer J.E.,Massachusetts General Hospital | Bangsberg D.R.,Harvard University
AIDS | Year: 2012

Although the balance of recent evidence supports the efficacy of antiretroviral (ARV)-based pre-exposure prophylaxis (PrEP) against HIV-1 infection, recent negative trial results are perplexing. Of seven trials with available HIV endpoints, three different products have been tested: tenofovir 1% vaginal gel, oral tenofovir disoproxil fumarate (TDF) tablets, and TDF/emtricitabine tablets. Six of these trials were conducted exclusively in sub-Saharan Africa; all found the products to be well tolerated, and four demonstrated effectiveness. Furthermore, the HIV Prevention Trial Network (HPTN) 052 trial recently confirmed that antiretroviral treatment leads to 96% reduction in transmission to HIV-negative partners in HIV-serodiscordant couples. These results, along with human and animal data, provide substantial evidence for the efficacy of antiretroviral-based HIV prevention. Yet assessment of oral TDF/emtricitabine in the FEM-PrEP study and of oral and vaginal tenofovir in the Microbicide Trial Network (MTN)-003 trial (VOICE) was stopped for futility. How do we make sense of these discrepant results? We believe that adherence is a key factor, although it cannot be the only factor. Expanding upon a recent editorial in the Lancet, we discuss the impact of suboptimal product adherence on PrEP efficacy in the context of variable drug concentration at the exposure site, integrity of the vaginal epithelium, and the role of acute infection. © 2012 Wolters Kluwer Health | Lippincott Williams & Wilkins.

Grimes D.A.,CB No 7570 | Schulz K.F.,FHI 360
Obstetrics and Gynecology | Year: 2012

Most reported associations in observational clinical research are false, and the minority of associations that are true are often exaggerated. This credibility problem has many causes, including the failure of authors, reviewers, and editors to recognize the inherent limitations of these studies. This issue is especially problematic for weak associations, variably defined as relative risks (RRs) or odds ratios (ORs) less than 4. Such associations, commonly reported in the medical literature, are more likely to be attributable to bias than to causal association. All observational research has bias (which can include selection, information, and confounding bias). Hence, detection of small associations falls below the discriminatory ability of observational studies. In general, unless RRs in cohort studies exceed 2 to 3 or ORs in case-control studies exceed 3 or 4, associations in observational research findings should not be considered credible. However, these guidelines are not foolproof: strong (yet spurious) associations can result when large amounts of bias are present. Only in a properly performed randomized controlled trial, free of bias, should small associations merit attention. Better training and more circumspection on the part of investigators, tougher editorial standards on the part of journals, and hefty skepticism on the part of referees and readers are necessary to avoid the dangers of false alarms, pseudo-epidemics, and their unfortunate consequences. © 2012 by The American College of Obstetricians and Gynecologists. Published by Lippincott Williams & Wilkins.

Bratt J.H.,FHI 360 | Zyambo Z.,FHI 360 Zambia
Journal of Acquired Immune Deficiency Syndromes | Year: 2013

Background: Rapid scale-up of voluntary medical male circumcision (VMMC) is needed to realize potential reductions in HIV incidence in sub-Saharan Africa. New disposable VMMC devices such as the Shang Ring may offer several advantages over standard surgery, including lower costs. Methods: We compared direct costs of the Shang Ring and dorsal slit techniques for delivery of VMMC in the context of a randomizedcontrolled trial carried out in Zambia in 2011. Information on direct costs of clinician time, disposable supplies, and reusable medical instruments were collected by study staff. Results: During the trial, the direct cost of 1 VMMC procedure using the Shang Ring device was US $18.21, whereas the direct cost of using dorsal slit was US $17.67. Higher costs of clinician time related to dorsal slit VMMC were offset by higher costs of disposable supplies with the Shang Ring approach. Discussion: Although direct costs were roughly equivalent during this small-scale trial, with the increased demand from scaling up VMMC, a Shang Ring team could provide services at a substantially lower average total cost due to the potential for more intensive use of staff and other fixed resources. Copyright © 2013 by Lippincott Williams & Wilkins.

Sanghvi T.,FHI 360
Food and nutrition bulletin | Year: 2013

Alive & Thrive aims to increase exclusive breastfeeding and complementary feeding practices in Bangladesh, Ethiopia, and Vietnam. To develop and execute comprehensive communication strategies adapted to each context. We documented how three countries followed an established iterative planning process, with research steps followed by key decisions, to develop a communication strategy in each country. Secondary analysis and formative research identified the priority practices to focus on, and locally specific constraints to proper infant and young child feeding (IYCF). Communication strategies were then developed based on the social, cultural, economic, epidemiological, media use, and programmatic contexts of each country. There were widespread gaps between recommended and actual feeding practices, and these varied by country. Gaps were identified in household, community, and institutional levels of awareness and skills. Strategies were designed that would enable mothers in each specific setting to adopt practices. To improve priority behaviors, messaging and media strategies addressed the most salient behavioral determinants through face-to-face communication, social mobilization, and mass media. Trials of improved practices (TIPs), concept testing, and pretesting of materials proved useful to verify the relevance and likely effectiveness of communication messages and materials tailored for different audiences in each setting. Coordination and collaboration with multiple stakeholders from the start was important to harmonize messages and approaches, expand geographic coverage to national scale, and sustain the interventions. Our experience with designing large-scale communication strategies for behavior change confirms that systematic analysis and local planning cannot be omitted from the critical process of strategic design tailored to each context. Multiple communication channels matched to media habits in each setting can reach a substantial proportion of mothers and others who influence their IYCF practices. Preliminary data suggest that exposure to mass media plays a critical role in rapidly reaching mothers, household members, community influentials, and health workers on a large scale. Combining face-to-face interventions for mothers with social mobilization and mass media was effective in improving IYCF practices.

Van Damme L.,FHI 360 | Szpir M.,FHI 360
Current Opinion in HIV and AIDS | Year: 2012

PURPOSE OF REVIEW: Recent studies suggest that the vaginal delivery of antiretroviral (ARV) agents - such as tenofovir, dapivirine and UC781 - may be a promising way to reduce the high rates of HIV infection among women in developing countries. This review examines these developments. RECENT FINDINGS: The Microbicide Trials Network 003 study, a large phase IIb trial, was unable to show that daily dosing with 1% tenofovir vaginal gel was effective for HIV prevention. Nevertheless, preclinical and early-phase clinical trials suggest that ARV drugs - formulated in vaginal gels, rings, films, tablets and diaphragms - could be effective for HIV chemoprophylaxis. SUMMARY: Investigations of topical chemoprophylaxis methods have seen mixed results in the past 12-18 months. Product adherence may prove to be one of the fields greatest challenges. Phase II and III trials continue to explore different dosing strategies for topical products that contain one or more ARV agents. © 2012 Wolters Kluwer Health | Lippincott Williams & Wilkins.

Wilcher R.,FHI 360 | Hoke T.,FHI 360 | Adamchak S.E.,FHI 360 | Cates Jr. W.,FHI 360
AIDS | Year: 2013

INTRODUCTION:: Increasing access to contraception among women who enter the health system for HIV care is crucial to help them achieve their fertility intentions and reduce vertical transmission of HIV. Identifying intervention strategies that contribute to effective family planning/HIV service integration and synthesizing lessons for future integration programming and research is important to move the field forward. METHODS:: Using a standard review methodology, we searched for articles in the peer-reviewed literature published between January 2008 and August 2013 that addressed the integration of family planning interventions into HIV service settings. Eligible studies were assessed in terms of methodological rigor; documented outcomes; and reported process and cost data. RESULTS:: Twelve studies met our inclusion criteria. Eight studies documented significant increases in contraceptive use by HIV service clients, and three reported significant increases in completed referrals from HIV services to family planning clinics. The outcomes of the seven studies implemented in public sector facilities were more modest than the five studies embedded in clinical trials. Process evaluation measures for some of the studies indicated weak implementation of the intervention as intended. The average rigor score was low, 3.4 out of 9. CONCLUSION:: Our review reveals an expanding evidence base for integrated family planning/HIV service delivery innovations. However, the modest observed effect under typical settings and the evidence of weak intervention implementation emphasize the need for stronger programmatic efforts and implementation research to address the health system obstacles to integrating these two essential services. © 2013 Wolters Kluwer Health | Lippincott Williams & Wilkins.

Wilcher R.,FHI 360 | Petruney T.,FHI 360 | Cates W.,FHI 360
Current Opinion in HIV and AIDS | Year: 2013

Purpose of Review: We reviewed recent literature on the role of family planning in eliminating new pediatric HIV infections. Recent Findings: Global commitments to eliminate new pediatric HIV infections recognize that preventing unintended pregnancies among women with HIV is essential to achieving this goal. However, substantial shortcomings exist in translating this policy support into widespread practice. Programs to prevent mother-to-child transmission of HIV continue to be implemented and evaluated as a narrow set of interventions that typically begins in antenatal care, after a woman is already pregnant. In addition, data suggest that women living with HIV experience high rates of unmet need for family planning and unintended pregnancies. Evidence is growing that integrating family planning and HIV services is an effective strategy for increasing access to contraception among women with HIV who do not wish to become pregnant. A number of health system obstacles must be resolved to achieve effective, sustained delivery of integrated services at scale. Summary: Prevention of unintended pregnancies among women with HIV must be elevated as a programmatic priority. By strengthening family planning programs for all women, and better integrating family planning and HIV services, progress toward ending new pediatric HIV infections will be accelerated. © 2013 Wolters Kluwer Health | Lippincott Williams & Wilkins.

Individual dietary intake data are important for informing national nutrition policy but are rarely available. National Household Consumption and Expenditures Surveys (HCES) may be an alternative method, but there is no evidence to assess their relative performance. To compare HCES-based estimates of the nutrient density of foods consumed by Ugandan women (15 to 49 years of age) and children (24 to 59 months of age) with estimates based on 24-hour recall. The 52 food items of the Uganda 2006 HCES were matched with nutrient content of foods in a 2008 24-hour recall survey, which were used to refine the HCES-based estimates of nutrient intakes. Two methods were used to match the surveys'food items. Model 1 identified the four or five most commonly consumed foods from the 24-hour recall survey and calculated their unweighted average nutrient contents. Model 2 used the nutrient contents of the single most consumed food from the 24-hour recall. For each model, 14 estimates of nutrient densities of the diet were made and 84 differences were compared. Models 1 and 2 were not significantly different. Of the model 2 HCES-24-hour recall comparisons, 67 (80%) did not find a significant difference. No significant differences were found for protein, fat, fiber, iron, thiamin, riboflavin, and vitamin B6 intakes. HCES overestimated intakes of vitamins C and B12 and underestimated intakes of vitamin A,folate, niacin, calcium, and zinc in at least one of the groups. The HCES-based estimates are a relatively good proxy for 24-hour recall measures of nutrient density of the diet. Further work is needed to ascertain nutrient adequacy using this method in several countries.

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