Predicting Harms and Benefits in Translational Trials

PLoS Medicine
(Accessed 13 March 2011)

Predicting Harms and Benefits in Translational Trials: Ethics, Evidence, and Uncertainty Jonathan Kimmelman, Alex John London Essay, published 08 Mar 2011

Summary Points
– Ethical judgments about risk, benefit, and patient eligibility in clinical trials hinge on predictions about harm, therapeutic response, and clinical promise.

– Predictions for novel interventions in preclinical stages of development suffer from two problems: insufficient attention to threats to validity in preclinical research and a reliance on an overly narrow base of evidence that includes only animal and clinical studies of the intervention in question (“evidential conservatism”).

– To improve ethical and scientific decision-making in early phase studies, decision-makers should explicitly attend to reporting quality and methodological features in preclinical experiments that address threats to internal, construct, and external validity.

– Decision-makers should also use evidence that sheds light on the reliability of causal claims embedded within a proposed trial. This evidence can be gathered from outcomes of previous trials involving agents targeting related biological pathways (“reference classes”).

WHO: China’s State Food and Drug Administration (SFDA) as functional vaccine regulatory system

A WHO-led team, following “a comprehensive review by experts from six countries,” concluded that the national regulatory authority of China, the State Food and Drug Administration (SFDA) and affiliated institutions, “meet WHO-published indicators for a functional vaccine regulatory system.” WHO said it has established benchmarks that define international expectations for a functional vaccine regulatory system, and that it also conducts “regular external audits of national regulatory authorities, particularly in vaccine-producing countries, to ensure that the regulatory systems meet the necessary standards, and that the system is maintained and functions in a sustainable way.” In addition to the general framework for the system, the following regulatory functions were evaluated: marketing authorization and licensing; post-marketing surveillance, including for adverse events following immunization; lot release by the national regulatory authority; laboratory access; regulatory inspections of manufacturing sites and distribution channels; and authorization and monitoring of clinical trials. WHO said the review’s conclusion “is the culmination of 19 months of intensive effort by the SFDA to implement a roadmap — developed by national experts, with continuous advice from WHO — to strengthen capacity for regulation of vaccines.”

WHO noted that, with a regulatory system for vaccines documented to comply with international standards, vaccine manufacturers in China are now eligible to apply for WHO prequalification of specific products, and that it is expected that vaccines from China could be prequalified 1-2 years from now. The eventual ability of United Nations procuring agencies to source vaccines from Chinese manufacturers “is expected to have a significant, beneficial impact on global supply of vaccines of assured quality.”

USAID: Support for GAVI shortfall

USAID Administrator Dr. Rajiv Shah, in a major address at the US National Institutes of Health (NIH), noted “the transformative public health impact of vaccines over the past decade and the potential of new immunisations against pneumococcal disease and the rotavirus to save 4 million lives and achieve a new breakthrough in global health and development.”  Dr. Shah described vaccines as “the best public health investment we can make” as he presented the U.S. Agency for International Development’s global health priorities and new initiatives. Shah also praised GAVI “as a proven mechanism and pledged to increase support in response to its financing needs and first ever replenishment.” He noted, “We will focus on one of the best lifesaving investments USAID has ever made: the first public funding of GAVI, the Global Alliance for Vaccines and Immunization. That initial investment has led to the prevention of more than 5 million childhood deaths, a mammoth return on investment by any account. We will expand our support of GAVI and help it address its current funding shortfall.”

AVI Alliance: U.K. Multilateral Aid Review (MAR), Support

The GAVI Alliance said it welcomed the results of the U.K.’s Multilateral Aid Review (MAR), which said GAVI “played a unique role in increasing finance for immunisation and bringing together all immunisation partners and wider partners in global health.” The review described GAVI as a “strong strategic fit with DFID (Department for International Development) priority objectives given its core focus on health and strong poverty focus.”  Further the report noted that “GAVI plays a critical role in the delivery of MDG 4 – reducing deaths among children under five years old. It contributes directly to MDG 5 and 6 through its support to health systems and impacts on MDG 1. The fact that these are some of the most off-track MDGs increases GAVI’s relevance as part of the international development system. It has significantly increased finance for vaccinations and substantially improved vaccination coverage of new and underused vaccines.”

Helen Evans, interim CEO at the GAVI Alliance, commented, “The GAVI business model is working well and despite some significant success in the area of pricing, we will not be satisfied until we see prices drop further and faster for all the vaccines that we work with. As a constantly learning organisation, we also note that this review has highlighted areas where we could do more to improve our performance.” The GAVI announcement said that, according to the review, “GAVI’s financial management is generally strong and transparent with evidence of recent improvements and safeguards (Transparency and Accountability Policy and strengthened audit capacity), although lessons on financial management and tracking of cash based investments (are) still to be effectively implemented.” Ms. Evans continued, “We are acutely aware that the financial systems in some of the countries we help are not as robust as those found in developed countries – it is a challenge faced by nearly all development organisations. It is our policy and practice to constantly monitor the use of our funds and immediately halt cash-based support wherever misuse is suspected.”

Global Fund: U.K. Multilateral Aid Review & Support; Mali program suspension

The Global Fund noted that it was one of 9 international organizations determined to have an “excellent track record” for delivering results and would receive increased funding in the future, based on the U.K. Multilateral Aid Review (MAR). The review “found that the Global Fund played a critical role in delivering health-related Millennium Development Goals (MDGs) and was likely to remain a key financier of existing and new approaches to tackling AIDS, tuberculosis and malaria.” The purpose of the Multilateral Aid Review, commissioned by the UK’s Department for International Development (DFID), was “to assess whether the UK is getting the best possible value for the money that it contributes to international organizations.” The review also gave the Global Fund “high marks for transparency and accountability, saying that the ‘Fund’s decision to publish/require recipients to publish procurement data has been a major driver for a range of innovations in transparency.’”

Separately, the Global Fund announced suspension of a US$13.91 million HIV/AIDS grant to Mali “with immediate effect until new arrangements for managing the grant are in place to safeguard Global Fund assets. The current Principal Recipient, Groupe Pivot Santé Population, will be replaced. The decision to suspend the grant comes after evidence was discovered that Global Fund grant money has been misused. It is part of a process of restoring confidence in the ability of Mali’s health sector to manage Global Fund resources appropriately.” In December 2010, the Global Fund suspended funding of two malaria grants in Mali and terminated a third grant for tuberculosis “after evidence of misappropriation and unjustified expenditure was found. The suspended grant provides funding for prevention programs, including condom distribution, voluntary counseling and testing and support for children who have been orphaned or made vulnerable by the AIDS epidemic. The grant suspension does not affect any of the 22,500 patients on antiretroviral treatment in Mali. They are financed by a second grant, managed by the National High Council for HIV/AIDS control of Mali, which is not affected by this decision.”

HHS: US$125 million to Novavax, VaxInnate for flu vaccine development

The U.S. Department of Health and Human Services (HHS) awarded two contracts “to help make vaccine available more quickly for seasonal flu outbreaks and pandemics.” The contracts involve “advanced development of new types of vaccine and new ways to make flu vaccine known as next-generation recombinant influenza vaccine and total US$215 million.” HHS Secretary Kathleen Sebelius said, “These next-generation flu vaccines hold the potential to be even more effective and to make the first and last doses of vaccine available sooner than existing flu vaccines by weeks and months which can save more lives during a pandemic as well as during seasonal flu outbreaks.” HHS awarded one of the contracts to Novavax, Inc.(Rockville, Md) for US$97 million over the first three years, which can be extended for an additional two years, for a total contract value of US$179.1 million. Under its contract, Novavax is “to develop new technology to produce vaccines using insect cells to express influenza proteins and create virus-like particles that stimulate a strong immune response in humans.” HHS awarded a separate contract to VaxInnate, Inc. (Cranbury, N.J.) for US$117.9 million over the first three years, which can be extended for two additional years, for a total contract value of US$196.6 million. VaxInnate is “developing a recombinant influenza vaccine technology based on combining influenza and bacteria proteins to stimulate strong immune response to protect against the flu.”

Through these contracts, both companies will conduct clinical safety and efficacy studies

Liquidia Technologies: Gates Foundation PRI: US$10 million

Liquidia Technologies announced the Bill & Melinda Gates Foundation made a US$10 million program-related investment (PRI) to support the company’s “development and commercialization of safer and more effective vaccines and therapeutics. This follows recent announcements of the first Liquidia clinical trial of its lead seasonal flu candidate (LIQ001) and a collaborative agreement with the PATH Malaria Vaccine Initiative (MVI).” Neal Fowler, CEO of Liquidia, said, “We are delighted the Gates Foundation has decided to join an outstanding group of investors that share our confidence in the potential of PRINT technology to improve vaccine delivery and effectiveness. As the field of vaccines continues to grow, success will be defined by our ability to produce and deliver highly efficacious therapies in quantities and costs that will support the global demand.”

THSTI and IAVI announce joint HIV vaccine design program in India

The Translational Health Sciences and Technology Institute (THSTI), an autonomous institute of the Indian government’s Department of Biotechnology, and the International AIDS Vaccine Initiative (IAVI) announced an agreement “to jointly establish, operate and fund an HIV Vaccine Design Program in India. The program will include the establishment of a new laboratory on the campus of THSTI in the National Capital Region of New Delhi…and will primarily focus on one of the greatest scientific challenges of AIDS vaccine design and development: the elicitation of antibodies capable of neutralizing a broad spectrum of circulating HIV variants, a problem that stems in large part from the almost unparalleled mutability of HIV.” M.K. Bhan, Secretary of the Department of Biotechnology, India, said, “With 7,100 people newly infected with HIV every day, effective tools to prevent infection are indispensible to the fight against HIV and AIDS. India alone has 2.7 million HIV-positive people within its borders. A broadly effective AIDS vaccine would be a powerful asset to efforts to arrest the spread of HIV. The Department of Biotechnology believes that it is only through partnerships like the one we have forged, involving international collaborations and the open sharing of scientific knowledge, that we will boost translational research and solve the complex global biomedical problems of our times.”

Seth Berkley, CEO of IAVI, said, “We are very excited about the launch of this collaboration. We are grateful for the unequivocal support this partnership has received from the Indian government and are confident it will contribute to ongoing efforts in India and elsewhere to design a broadly effective AIDS vaccine. India has an exceptional reserve of top-notch researchers, some of whom are already working closely with IAVI.”

Twitter Watch: 7 March 2011

Twitter Watch
A selection of items of interest this week from a variety of twitter feeds. This capture is highly selective and not intended to be exhaustive.

EndPolioNow EndPolioNow
Buy tickets for Itzhak Perlman in Chicago, 7 March, for the Concert to End Polio.

gatesfoundation Gates Foundation
VOTE: Creative ideas raising awareness on #vaccines and their vital importance for #globalhealth:

AIDSvaccine IAVI
@USAID Admin Raj Shah gives #TED talk on #science, #tech & #innovation for #globaldev, #globalhealth:

sabinvaccine Sabin Vaccine Inst.
This is a spectacular video @onecampaign – A #Rotavirus Vaccine’s Journey:

Hepatitis B Virus in the United States

Annals of Internal Medicine
March 1, 2011; 154 (5)

Original Research
Hepatitis B Virus in the United States: Infection, Exposure, and Immunity Rates in a Nationally Representative Survey
George N. Ioannou
Ann Intern Med March 1, 2011 154:319-328; doi:10.1059/0003-4819-154-5-201103010-00006

Current estimates of the prevalence of hepatitis B virus (HBV) infection, exposure, and immunity are needed to assess the effectiveness of programs to prevent transmission. This study of 39 787 participants in the National Health and Nutrition Examination Survey (1999 to 2008) found that among persons aged 6 years or older, 0.27% (approximately 704 000) had chronic HBV infection and 4.6% (approximately 11 993 000) had been exposed to HBV. Infection and past exposure were uncommon among persons aged 6 to 19 years, and 68.6% of children aged 2 years had immunity. The investigator concludes that vaccination of high-risk adults should continue to be emphasized.

High-Value, Cost-Conscious Health Care

Annals of Internal Medicine
March 1, 2011; 154 (5)

High-Value, Cost-Conscious Health Care: Concepts for Clinicians to Evaluate the Benefits, Harms, and Costs of Medical Interventions
Douglas K. Owens, Amir Qaseem, Roger Chou, Paul Shekelle, and for the Clinical Guidelines Committee of the American College of Physicians
Ann Intern Med February 1, 2011 154:174-180;

Health care costs in the United States are increasing unsustainably, and further efforts to control costs are inevitable and essential. Efforts to control expenditures should focus on the value, in addition to the costs, of health care interventions. Whether an intervention provides high value depends on assessing whether its health benefits justify its costs. High-cost interventions may provide good value because they are highly beneficial; conversely, low-cost interventions may have little or no value if they provide little benefit.

Thus, the challenge becomes determining how to slow the rate of increase in costs while preserving high-value, high-quality care. A first step is to decrease or eliminate care that provides no benefit and may even be harmful. A second step is to provide medical interventions that provide good value: medical benefits that are commensurate with their costs.

This article discusses 3 key concepts for understanding how to assess the value of health care interventions. First, assessing the benefits, harms, and costs of an intervention is essential to understand whether it provides good value. Second, assessing the cost of an intervention should include not only the cost of the intervention itself but also any downstream costs that occur because the intervention was performed. Third, the incremental cost-effectiveness ratio estimates the additional cost required to obtain additional health benefits and provides a key measure of the value of a health care intervention.

Rationing healthcare by thresholds of minimum effectiveness

British Medical Journal
5 March 2011 Volume 342, Issue 7796

Ethics and effectiveness: rationing healthcare by thresholds of minimum effectiveness
Alena M Buyx, Daniel R Friedrich, Bettina Schöne-Seifert

Alena Buyx, Daniel Friedrich, and Bettina Schöne-Seifert argue that basing rationing decisions on clinical effectiveness rather than cost effectiveness would be fairer and could make it more acceptable

Scarcity of healthcare resources calls for fair, acceptable, and ethically justified ways of allocating and rationing care. Particularly in financially difficult times, this is a formidable challenge. So far, no developed country has managed to introduce criteria for fair rationing that have remained undisputed. This is not surprising. Rationing healthcare by definition goes beyond eliminating waste 1 and thus requires difficult moral choices. 2 Whoever gets afflicted, it almost always hurts, and cuts must therefore have sound ethical justification. Cost effectiveness in particular—one of the main criteria used by the National Institute for Health and Clinical Excellence (NICE) in funding decisions—has long been attacked for ethical reasons. 3

One simple criterion for rationing that has been paid little attention is minimum effectiveness thresholds. Although public debates show increasing reservations about expending enormous effort for very small clinical benefit, 4 medical interventions with only minimal effects seem to be part of today’s regular medical practice. For example, some of the newly approved monoclonal antibody drugs for end stage cancer at best prolong patients’ lives for a few weeks or months without any substantial improvement in their health related quality of life. Reasons for the prevalence of such treatments are manifold: in many Western countries, doctors prescribe the drugs because they are (often wrongly) afraid of legal liability or dread to admit that “there is nothing more we can do”; patients dwell on unrealistic hopes; and relatives have trouble facing their loved one’s end. 5 6

We think it is irrational and wrong to ration clearly effective treatments while offering others that promise very low individual benefits. Before other cuts are considered, …

Pneumococcal Conjugate and Polysaccharide Vaccination in Adults

Clinical Infectious Diseases
Volume 52 Issue 6 March 15, 2011
Rajeka Lazarus, Elizabeth Clutterbuck, Ly-Mee Yu, Jaclyn Bowman, Elizabeth A. Bateman, Linda Diggle, Brian Angus, Tim E. Peto, Peter C. Beverley, David Mant,
and Andrew J. Pollard

A Randomized Study Comparing Combined Pneumococcal Conjugate and Polysaccharide Vaccination Schedules in Adults
Clin Infect Dis. (2011) 52(6): 736-742 doi:10.1093/cid/cir003

Combined schedules of pneumococcal conjugate and polysaccharide vaccines do not provide enhanced immunogenicity for the seven serotypes tested in comparison to a single dose of pneumococcal conjugate vaccine in adults.

Bridging Implementation, Knowledge, Ambition Gaps to Eliminate Tuberculosis

Emerging Infectious Diseases
Volume 17, Number 3–March 2011

Bridging Implementation, Knowledge, and Ambition Gaps to Eliminate Tuberculosis in the United States and Globally
K.G. Castro and P. Lobue

We reflect on remarkable accomplishments in global tuberculosis (TB) control and identify persistent obstacles to the successful elimination of TB from the United States and globally. One hundred and twenty nine years after Koch’s discovery of the etiologic agent of TB, this health scourge continues to account for 9.4 million cases and 1.7 million deaths annually worldwide. Implementation of the Directly Observed Treatment Short-course strategy from 1995 through 2009 has saved 6 million lives. TB control is increasingly being achieved in countries with high-income economies, yet TB continues to plague persons living in countries with low-income and lower-middle–income economies. To accelerate progress against the global effects of disease caused by TB and achieve its elimination, we must bridge 3 key gaps in implementation, knowledge, and ambition.

Civil society in ASEAN

The Lancet
Mar 05, 2011 Volume 377  Number 9768  Pages 783 – 874

Civil society in ASEAN: a healthy development?
Andrew Wells-Dang, Giang Wells-Dang

Across southeast Asia, local citizens engage in collective action for health, the basis of networks of trust that are often overlooked by state agencies and external observers. Informal groups and Buddhist monks provided first aid and food assistance to survivors after Myanmar’s cyclone Nargis in 2008, in the absence of governmental and external assistance.1,2 In Vietnam, support provided by local Buddhist and Catholic congregations, and organisations such as the Women’s Union, have expanded to fill the increase in demand for local health services as the previously subsidised state monopoly splintered into an uneven mixture of public and private health providers.

Measles eradication: Heymann et al 2010: correspondence

The Lancet
Mar 05, 2011 Volume 377  Number 9768  Pages 783 – 874

Measles eradication
Athalia Christie, Andrea Gay
The recommendation by David Heymann and colleagues (Nov 20, p 1719)1 that high routine immunisation coverage be a prerequisite for measles campaigns or a measles eradication goal disregards current policy and the progress made in the past decade.

Measles eradication
David N Durrheim, Hyam Bashour
David Heymann and colleagues1 consider progress towards regional elimination of measles a distraction from polio eradication efforts. However, measles vaccine has proven one of the most cost-effective measures for saving vulnerable children’s lives. Attaining high coverage of measles immunisation worldwide represents one of the most effective propoor strategies available.2

Measles eradication
Jon Kim Andrus, Ciro A de Quadros
We share David Heymann and colleagues’ concern that “any eventual strategy for measles eradication should truly strengthen routine immunisation and should not become a substitute”.1 Simply put, any measles eradication strategy should strengthen the overall health system’s capacity for improved surveillance and delivery of services, not just immunisation. That was the experience with the eradication of poliomyelitis, measles, and, more recently, rubella and congenital rubella syndrome in the Americas.

Measles eradication – Authors’ reply
David Heymann, Paul E Fine, Ulla K Griffiths, Andew J Hall
We welcome the comments on a proposed measles eradication strategy, and the further debate on measles eradication that has ensued. That, in fact, was our hope as we wrote the Comment about potential measles eradication strategies. As the correspondents point out, measles elimination—which includes periodic measles vaccination campaigns—is currently underway, and five of the six WHO regions have set elimination targets. Elimination is not eradication, although the terms are often confused.1

Save the Children Report: “No Child Born to Die”

The Lancet Infectious Disease
Mar 2011  Volume 11  Number 3  Pages 153 – 252

News Desk
Vaccine progress reveals resource gaps in developing countries
Talha Khan Burki

In 1990, the baseline year for the Millennium Development Goals, more than 12 million children died before reaching their fifth birthday. By 2009, this number had been reduced to 8 million. Sturdy progress, certainly, but if Millennium Development Goal 4—which aims to reduce child mortality by two-thirds by 2015—is to be achieved the present rate of decline will not suffice. A new report by Save the Children, No Child Born to Die, warns of three resource gaps—immunisation, health workers, and financing—that are impeding progress towards the attainment of Millennium Development Goal 4.

Pdf at:

Hib Vaccination Coverage During Shortage

March 2011 / VOLUME 127 / ISSUE 3

Up-to-Date Haemophilus influenzae Type b Vaccination Coverage During a Vaccine Shortage
Karen E. White, Laura J. Pabst, and Karen A. Cullen
Pediatrics 2011; 127: e707-e712

OBJECTIVES We sought to assess Haemophilus influenzae type b (Hib) vaccination coverage in diverse areas of the United States during the 2008–2009 Hib vaccine shortage. Interim recommendations for Hib vaccination during the shortage called for deferral of the booster dose only among children not at high risk for disease; the primary series given during the first year of life continued to be recommended for all children.

METHODS Vaccination data on 123 000 children were collected from 8 Immunization Information System (IIS) sentinel sites. Completion of the primary Hib series (with 2 or 3 doses depending on vaccine type) by 9 months old during the vaccine shortage was compared with coverage of 2 vaccines given at similar ages (7-valent pneumococcal conjugate vaccine and diphtheria, tetanus acellular pertussis vaccine) in children born between November 1, 2007, and March 31, 2008.

RESULTS During the shortage period, Hib vaccination coverage for the primary series was 7.8 to 10.3 percentage points lower than diphtheria, tetanus acellular pertussis vaccine and 7-valent pneumococcal conjugate vaccine coverage for children by the age of 9 months in 7 of 8 sentinel sites.

CONCLUSIONS A significant decrease in Hib vaccination coverage for the primary series was observed and was consistent across several US localities. Close collaboration between the public health community and vaccine providers is essential during vaccine shortages to ensure that interim vaccination recommendations are clear, widely disseminated, and closely followed, and that access to available vaccine supplies is maintained.

Herd immunity post rotavirus vaccination program: Austria

Volume 29, Issue 15 pp. 2649-2822 (24 March 2011)

Herd immunity after two years of the universal mass vaccination program against rotavirus gastroenteritis in Austria Original Research Article
Pages 2791-2796
Maria Paulke-Korinek, Michael Kundi, Pamela Rendi-Wagner, Alfred de Martin, Gerald Eder, Birgit Schmidle-Loss, Andreas Vecsei, Herwig Kollaritsch

Austria was the first country in Europe implementing a universal mass vaccination program against rotavirus gastroenteritis (RV-GE) for all infants nationwide. Epidemiological data from a hospital based surveillance system show that incidence rates of children hospitalized with RV-GE decreased in 2009 compared to 2008 and compared to the prevaccination period 2001–2005. Decreasing hospitalization-rates from RV-GE were observed in children of all age groups, even in those not eligible for vaccination according to their age, suggesting herd immunity induced by universal mass vaccination against RV-GE. In 2009 the disease burden was highest in children below three months of age stressing the importance of the early start of the immunization course.

Text message reminders to promote HPV vaccination

Volume 29, Issue 14 pp. 2509-2648 (21 March 2011)

Text message reminders to promote human papillomavirus vaccination

Original Research Article
Pages 2537-2541
Elyse Olshen Kharbanda, Melissa S. Stockwell, Harrison W. Fox, Raquel Andres, Marcos Lara, Vaughn I. Rickert

Objective: To implement and evaluate text message reminders for the second (HPV2) and third (HPV3) vaccine doses.

Design: Site-based intervention.

Setting: Nine pediatric sites (5 academic and 4 private) located in New York City.

Participants: Parents of adolescents 9–20 years who received HPV1 or HPV2 during the intervention period, January–June 2009.

Intervention:Parents who enrolled received up to three weekly text message reminders that their daughter was due for her next vaccine dose.

Outcome measure: On-time receipt of the next vaccine dose, within one month of its due date.

Results: During the intervention period, of 765 eligible HPV vaccine events, 434 enrollment instructions were distributed to parents (56.7% of doses). Parents of 124 adolescent girls (28.6% of those handed instructions) activated text message reminders. Comparing children of parents who enrolled versus those who did not, on-time receipt of next HPV vaccine dose occurred among 51.6% (95% CI 42.8–60.4%) versus 35.0% (95% CI 29.6–40.2%) of adolescents (p = .001). Similarly, among a historical cohort of adolescents, receiving HPV1 or HPV2 in the six months prior to the intervention period, on-time receipt of next vaccine dose was noted for 38.1% (95% CI 35.2–41.0%) (p = .003). Increases in receipt of next vaccine dose among intervention subjects were sustained at 4 months following the vaccine due date. Using a logistic regression model, after controlling for insurance and site of care, intervention subjects were significantly more likely than either control population to receive their next HPV vaccine dose on-time.

Conclusion: Among those choosing to enroll, text message reminders were an effective intervention to increase on-time receipt of HPV2 or HPV3.

Mothers’ support for voluntary HPV vaccination in schools

Volume 29, Issue 14 pp. 2509-2648 (21 March 2011)

Mothers’ support for voluntary provision of HPV vaccine in schools

Original Research Article
Pages 2542-2547
Jessica A. Kadis, Annie-Laurie McRee, Sami L. Gottlieb, Morgan R. Lee, Paul L. Reiter, Patricia J. Dittus, Noel T. Brewer

HPV vaccination rates among adolescents in the United States lag behind some other developed countries, many of which routinely offer the vaccine in schools. We sought to assess mothers’ willingness to have their adolescent daughters receive HPV vaccine at school. A national sample of mothers of adolescent females ages 11–14 completed our internet survey (response rate = 66%). The final sample (n = 496) excluded mothers who did not intend to have their daughters receive HPV vaccine in the next year. Overall, 67% of mothers who intended to vaccinate their daughters or had vaccinated their daughters reported being willing to have their daughters receive HPV vaccine at school. Mothers were more willing to allow their daughters to receive HPV vaccine in schools if they had not yet initiated the vaccine series for their daughters or resided in the Midwest or West (all p < .05). The two concerns about voluntary school-based provision of HPV vaccine that mothers most frequently cited were that their daughters’ doctors should keep track of her shots (64%) and that they wished to be present when their daughters were vaccinated (40%). Our study suggests that most mothers who support adolescent vaccination for HPV find school-based HPV vaccination an acceptable option. Ensuring communication of immunization records with doctors and allowing parents to be present during immunization may increase parental support.

Reaching Every District (RED) strategy – Assam, India: 2005–2008

Volume 29, Issue 14 pp. 2509-2648 (21 March 2011)
Implementation and evaluation of the Reaching Every District (RED) strategy in Assam, India, 2005–2008 Original Research Article
Pages 2555-2560
Tove K. Ryman, Ajay Trakroo, Aaron Wallace, Satish Kumar Gupta, Karen Wilkins, Pankaj Mehta, Vance Dietz

In 2005, UNICEF and the Centers for Disease Control and Prevention implemented and evaluated the Reaching Every District (RED) approach, an intervention designed to improve key components of immunization services including planning, outreach, community mobilization, supervision, and monitoring, in select districts of Assam, India. Two intervention and 3 comparison districts were selected for a 2-year evaluation trial. In intervention districts, immunization staff received comprehensive training and ongoing supervision by a fulltime consultant, and regular monitoring of progress was conducted. Population-based vaccination coverage surveys were conducted at baseline and 2 years after the start of implementation in the 5 districts. Post-intervention process indicators were systematically collected and focus group discussions were held. At follow-up, children in both the intervention and comparison districts were twice as likely to be fully vaccinated as they were at baseline. However, sites that received intervention training were better performing than those that did not, as measured by process indicators, including a higher number of outreach visits planned and held (p = 0.02), having a monitoring chart (p < 0.01), and correctly calculating dropout (p < 0.01). The number of supervisory visits was significantly and positively associated with other key process indicators. Although coverage did not differ significantly between intervention and comparison districts, among individual districts, process data indicate significant improvements in program quality in the intervention districts. Further studies are needed to determine if the improved process indicators have sustainable impact on maintaining improvements in coverage.