Comments on the NIH Office of Disease Prevention Strategic Plan for Fiscal Years 2014-2018

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1. Strategic Priority I: Systematically monitor NIH investments in prevention research and assess the progress and results of that research

The strategic plan does not give any detail on how they will assess prevention research success, i.e. what yardsticks will be used.  It is important to determine the best “portfolio analysis tools” to be used and exactly what factors will be considered.  In addition to simple process measures such as the number of grants awarded, number of articles published and similar traditional factors, we urge that NIH also consider both intermediate and long-term measures associated with improved public health outcomes. While improvement in public health measures can be more challenging to assess, and requires a longer time period to evaluate, the goal of prevention research should be focused on measurable health outcomes, and not simply on the number of grants or scientific publications.  A more explicit identification and prioritization of research goals would increase confidence that meaningful public health results will be achieved where they are most urgently needed.

We wish to also commend NIH for recognizing, by adopting an appropriate definition of primary prevention, the important role that policymaking can play in the primary prevention of disease, illness, injury, or disability.  We suggest that as part of its evaluation of the research portfolio, there also be an assessment of the balance among clinical, lifestyle, and policy and systems interventions.

2. Strategic Priority II: Identify prevention research areas for investment or expanded effort by the NIH

There are several critical areas in prevention research which are not addressed in this section.  Despite NIH’s proposed definition of prevention research as pertaining to “factors in the social and physical environments”, the only environmental factor explicitly mentioned is water supply quality. Within the NIH, the NIEHS has identified other environmental exposures of public health concern which are relevant to disease prevention, such as agricultural chemicals and endocrine disrupting chemicals in personal care products ^[1], and these topics have received increasing attention from other federal agencies as well, such as the EPA and CDC ^[2].  Given the increasing evidence of biologically active agents in many environmental sources, further attention to these issues by the ODP is warranted, as their stated goal here is to expand prevention research areas.  The ODP-supported Healthy People site includes information on occupational safety and environmental health issues, but many topics were not addressed.

Beyond environmental health interventions, we hope that efforts to identify prevention research areas will adequately consult researchers and interested stakeholders who understand that the social determinants of health play an important role in determining health outcomes.  We likewise urge NIH to ensure that this strategy recognize the importance of research to better examine how public health, community-based, and other types of interventions and programs aimed at addressing the social determinants of health, including substance abuse, unemployment, low-incomes, homelessness, and many others, can help improve health outcomes.

3. Strategic Priority III: Promote the use of the best available methods in prevention research and support the development of better methods

This section does not explicitly define “best available methods”, i.e. what benchmarks will be considered meritorious?  A challenging issue in prevention research is the feasibility and incentive for longer term trials, as opposed to relying on surrogate markers when assessing chronic disease.  Furthermore, as this report states, “there is ample evidence that better training for investigators, program staff, review staff, and reviewers is needed.  Consider, as an example, a recent review of group-randomized trials involving cancer and cancer risk factors. Murray et al. (2008) found 75 studies published across 41 peer-reviewed journals between 2002 and 2006. Only 45% reported analyses that were entirely appropriate. This pattern held even for studies reviewed by NIH study sections and funded by NIH Institutes and Centers”.  From this statement, it is clear that this is an area of alarming concern. As the NIH is the principal funding agency for these studies, it must lead the way in improving science quality.  Although “training” is mentioned, specific efforts to address this problem, such as continuing education requirements for grantees, should be considered and outlined here.

As it supports research using the best available existing methodologies and the development of better methods, we urge NIH to ensure that prevention research adequately include cost-effectiveness and return-on-investment calculations to help practitioners and policymakers understand the value of prevention interventions.  Such calculations can also help determine whether an intervention should be brought to scale.

4. Strategic Priority IV: Promote collaborative prevention research projects and facilitate coordination of such projects across the NIH and with other public and private entities

This section was quite general, especially given the daunting task of coordinating research within the NIH and also with other public and private sector institutes.   A more specific outline of how collaborations will be conducted would be helpful in ensuring that resources are used most efficiently during these fiscally challenging times.  Requiring every agency within HHS to have representation on the PRCC might be one such mechanism for streamlining these efforts.

We respectfully urge the NIH to consider the success of the Diabetes Prevention Program (DPP) as a model for research translation.  As you are aware, the original study that demonstrated the efficacy of the DPP was supported by NIH. This model was adapted by CDC and deployed at YMCA sites across the United States, effectively translating clinical results into a community-based prevention program.  We believe the DPP demonstrates the important role that research translation plays in designing public health interventions and could serve as an excellent case study as NIH considers how this strategy will ensure that prevention research is coordinated with CDC, SAMHSA, HRSA, and other appropriate public and private partners.

Similarly, the U.S. Preventive Services Task Force found that fall prevention programs for the elderly can reduce the falls that cause hip fractures and hospitalizations, and other studies have shown that these programs can be cost-effective.^[3] In contrast, osteoporosis screening and medications tend to improve bone mineral density but do not reduce hip fractures or hospitalizations.^[4]

5. Strategic Priority V: Identify and promote the use of evidence-based interventions and promote the conduct of implementation and dissemination research in prevention

A critical need which was not addressed in this section is the timely dissemination of clinical trial data to the public.  As a recent study demonstrated, a disturbing number of clinical trials results are not posted on ClinicalTrials.gov (78% of unpublished trials do not have data posted).^[5]    In addition, almost one-third (29%) had not been published within 5 years of completion.  This issue must be remedied to ensure that such costly investments are carried to fruition.

While this section provided substantial details regarding efforts in online communications, one remaining area of concern is that NIH has drastically cut back on printing informational pamphlets for patients.   While we agree that “the process of getting information out to the public has changed dramatically in the last decade. Traditional modes of communication such as printed pamphlets and brochures are being replaced by digital communication tools,” many individuals do not have easy access to computers and printers, making it difficult for them to fully use electronic patient materials.  While we applaud the NIH for its environmental considerations and increased use of diverse avenues of communication, these plans must ensure that information is easily accessible for all Americans, not just those that have easy access to electronic media as well as printers.

6. Strategic Priority VI: Increase the visibility of prevention research at the NIH and across the country

Similar to Priority V, this section focuses primarily on electronic means of communication.  While these modes of communication are helpful within the scientific community and among certain demographic groups, this section needs to identify how other means of communication will be utilized to ensure that prevention research is as broadly visible and accessible to the public as possible.