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Dr. Fielding said the Committee had recommended that HHS undertake developmental activities around information technology. He asked Ronald Manderscheid, Chair of the Subcommittee on Information Technology, to elucidate any additional work that would be needed in that area. Dr. Manderscheid explained that one key activity would be around developing the public health information infrastructure of the United States (e.g., epidemiological data, services data, and encounter data) so that these data are accessible to users at the federal, state, and county levels. He saw a need to take that recommendation and flesh it out into operational steps. Second, the Committee had approved a recommendation that HHS develop a national, online Healthy People community around the goals and interventions of Healthy People. This should go all the way from self-help (i.e., a person addressing a health problem) all the way up to county-level efforts. Dr. Manderscheid said this would be a major undertaking, and thus there is a need to think through how such development would be phased. Dr. Fielding asked that the subcommittee on health IT proceed with creating a framework for these two areas.

Turning to the issue of indicators, Dr. Fielding asked for guidance from ODPHP on what would be most helpful. Ms. Blakey explained that they have a huge collection of objectives which some people say are indicators and others do not. With that large number, the sense of focus has been lost. Healthy People needs to identify the indicators that it will use to track identified priorities. Healthy People is not the only source of indicators; other projects and organizations are producing indicator sets as well. The Assistant Secretary for Health has noted the large number of objectives, and would like to see a smaller set of indicators. Another issue is whether there should be a set of indicators developed for social determinants or for quality of life. Dr. Fielding asked for the development of a paper examining the issues involved in setting indicators so this question can be discussed at the next meeting.

Dr. Fielding said additional work is needed for implementation of Healthy People 2020, and asked Eva Moya and Adewale Troutman, Subcommittee Co-chairs, to comment. Ms. Moya said that better background guidance (i.e., a document) is needed to help users. Specifically, the Subcommittee should look at what steps are entailed in implementation, and then identify resources needed to make those things happen. She felt it would be useful to consolidate the work of the FIW’s Implementation Subgroup and the FACA’s Subcommittee on Implementation to ensure they are being strategic about coordinating their efforts. Dr. Fielding suggested that the Subcommittee on Implementation incorporate the comments from this meeting into their final recommendations and send the document on to the Secretary. He also suggested setting up a joint meeting with the FIW Subgroup on Implementation to look at opportunities for collaboration.

II. Continued Discussion: Priorities in Healthy People 2020

10:00 AM- 11:00 AM

Dr. Meltzer, Chair of the Subcommittee on Priorities, summarized the approach to priority-setting that was refined by Subcommittee members after the previous day’s meeting adjourned. He explained that there are four areas for prioritization, broken down under three bullets (see Exhibit A.).

Exhibit A. Summarized approaches to priority setting.

Advisory Committee Recommendation:

  1. Priority setting for interventions within topic areas.
  2. Priority setting for interventions in each non-health sector.
  3. Priority-setting for interventions that cut across topic areas
    1. Interventions that address the major risk and protective factors for common diseases
      1. e.g., 3- four -50
    2. Interventions that address modifiable social and physical environmental determinants of health

The first bullet is about using tools to set priorities among interventions within broad topic or disease areas. A variety of approaches have been discussed for how to accomplish that, including specific measures of health benefits and costs. The second bullet addresses the importance of setting priorities interventions in each non-health sector. It reflects the notion that, for example, one could go to the Department of Education and say, “Tell us what are the things that you think you could do that would make the biggest difference in terms of health benefits.” The point is that one would engage departments that might not traditionally think of themselves as producing health and ask, “How can you do that? Or what might you do?” These issues might be crosscutting, or they might be disease-specific. The third bullet conveys the idea that priorities should be set for interventions that cut across topic areas. These are interventions that address major risk factors for common diseases.

Dr. Meltzer said he preferred the version that was produced the day before. However, he did like the idea of prioritizing within non-health sectors. A Committee member suggested that it might be possible to present this information graphically or in tabular form to clarify its meaning, or at least to prove that the Committee itself understands it. Dr. Fielding acknowledged that it might be worthwhile to experiment with presenting the information differently, but it would be more important to provide concrete examples. The Committee has spent a lot of time on this; he was hopeful that the FIW would understand it. He approved sending this back to the Subcommittee for word-smithing, but more importantly, for framing it with examples so that people will understand it. The FIW should be informed that this represents the Committee’s best thinking about an approach to priority-setting.

Dr. Fielding said the Secretary or the Domestic Policy Council should consider convening non-HHS departments to discuss their role in improving health. Others suggested the approach to priority-setting should be put into the context of a short paper, and it should be clarified that priority-setting entails a broader social process (e.g., convening a priority-setting group, or working through the Domestic Policy Council). The priority-setting bullets need more depth so that the words are meaningful for whoever will to take them forward. Dr. Kumanyika added that she would like the conversation with other sectors to be more bidirectional, because there are things that the health sector could do to help them reach their goals, like maintain a functional workforce. It is important to look at payoffs that other sectors will gain for improving health, and to avoid unidirectional thinking. Another point raised was that, in addition to addressing “risk factors,” the priority-setting approach should refer to “risk and protective factors.” Dr. Fielding agreed that primary prevention is important to the third bullet. He suggested the priority-setting approach be circulated to the Committee again to ensure that it adequately addresses primary prevention. Before transitioning to the next section of the agenda, Dr. Fielding noted that this issue might lend itself well to publication.

Two additional issues related to priority-setting were raised during subsequent discussion in the afternoon. Dr. Michael McGinnis remarked that the notion of establishing priorities in other sectors seems inappropriate. Healthy People 2020 should not seek to establish priorities in other sectors, but should work with other sectors around their priorities. Second, a member said the lack of priority-setting has been an impediment to the success of Healthy People in the past. He recommended using examples to illustrate what one gives up when one does not make choices.

Dr. Fielding welcomed Dr. Michael McGinnis by saying that no one knows more about the Healthy People process, has a longer history with it, or has had more impact on its successes than Dr. McGinnis. He thanked Dr. McGinnis for attending the meeting to discuss the use of evidence in Healthy People, and invited his comments on priority-setting or other issues.

III. Selecting Evidence-based Actions

11:00 PM- 12:00 PM

Dr. Fielding opened the discussion by commenting that everything is evidence. Even a story is evidence. The question isn’t whether one uses evidence, but what kind of hierarchy of evidence is available to help make decisions. For Dr. McGinnis’ benefit, Dr. Fielding explained that on the previous day, the Committee had discussed the FIW’s draft guidelines for selecting, developing and submitting evidence-based action steps and strategies for achieving Healthy People objectives. Dr. Fielding had expressed serious concerns about some of the recommendations in the document that the FIW had shared with the Committee. While he felt it was important to be inclined toward action, Dr. Fielding hoped to produce guidelines that would yield evidence-informed action. What constitutes the range of evidence that is useful? How do we help people to understand that there are big differences between a case study and a systematic review? He invited Dr. McGinnis to present general comments on this and other issues.

Dr. McGinnis commended the Committee for their commitment to the continued advancement and improvement of the Healthy People process. Before commenting on evidence, he offered some general remarks on the Healthy People process. To begin, he urged participants to avoid repeating past mistakes in Healthy People 2020.

  • First, he noted the past error of not stratifying the objectives. The first iteration of Healthy People included 226 objectives; this was too many. The objectives were not ranked or stratified. There is a critical need for a set of sentinel objectives; early architects of Healthy People did not create that until 2000.
  • Second, even though they created flagship objectives in Healthy People 2000, they were not a success because Healthy People failed to communicate about them. He stressed that communication is an important part of the deliberative process. It is essential to marshal the will and activity of the key people involved.
  • Third, not embedding a soaring vision in the goals was a mistake. The goals were not wrong. Goals are a summary measure and broad aim. They ought to be not only a summary that captures the key elements, but also visionary. In the first iteration of Healthy People, the goals were not aspirational or inspirational. They were life stage goals, reducing mortality for various age groups. Healthy People was successful in hitting its targets, but it wasn’t inspirational. Even the Healthy People 2000 effort was bound by the wrong-headed notion that it should be limited to the achievable. While one certainly could not eliminate disparities within a decade, disparities should not be tolerated. It would have been preferable to establish goals that would give the nation a sense of the possible.

Dr. McGinnis highlighted several elements of the early Healthy People efforts that were effective. These were:

  1. The objective process was viewed primarily as a communication vehicle to give the nation a sense of the possible. In prevention, success is achieved when things don’t happen, so it can be difficult to celebrate.
  2. The conceptual framework was valuable for communicating about prevention. It included health promotion (behavioral things), protection (things that can be done to protect from exposures), and clinical preventive services. He added that we now know that health is much more a product of social determinants. The way that information is structured so that it can be captured at a glance is important.
  3. Healthy People was true to the science. The objective targets were meant to be national because the concern was that if they were just Federal targets they would not survive a change in administration.

Dr. McGinnis emphasized that, in addition to hierarchies of evidence, there are hierarchies of opportunity and obligation. What is important for the Federal government to take on because it is within their purview and is important? He recommended not being slavish in adhering to specific taxonomies of evidence, as evidence is dynamic. This is an activity where one might argue that the process is more important than the product; it is critical to give as much opportunity as possible for stakeholders to engage. Dr. McGinnis supported the FIW’s proposed “star system” of rating potential actions. Yet he cautioned that some systematic reviews are not well-executed, and, therefore, they should not automatically be given a gold star. He endorsed the idea of having the Committee work hand-in-hand with the FIW and recommended ensuring that the FIW representatives speak with their agency heads. Dr. Fielding thanked Dr. McGinnis for his remarks, clarifying that the Committee’s role is an advisory one.

Dr. Fielding asked for comments on two briefing book documents offering guidance for selecting evidence-based actions—one by a subcommittee of the Advisory Committee (Jonathan Fielding, Steve Teutsch, Michael McGinnis, Tracy Orleans, and Russ Glasgow contributed), and another by the FIW. Ms. Blakey explained that the FIW is trying to be as inclusive as possible and recommend an action strategy for each objective. There is some disagreement about what levels of evidence are needed in order for a particular strategy to be included in Healthy People. If they are going to develop a Web site, as the Federal government, any information that is posted there must be well-supported. Yet if their inclusion criteria are too stringent, they may not meet the needs of all of their users.

A member commented on the need for more evidence. The fact that the evidence is not well developed in some areas presents an opportunity, because it should be possible to provide input into how that evidence is developed. He called for examining HHS’ activities across the different agencies, not just in the clinical area. As part of the National Health Reform effort, level A and B evidence will be required for payment; a parallel approach is needed on the public health side. He noted that $1.1 billion are being put into comparative effectiveness research this year as part of the ARRA, and suggested the Committee make a recommendation regarding the importance and the priority of developing evidence in some of the key areas that of Healthy People 2020.

Dr. McGinnis added that stronger focus on gathering evidence will be needed once the Healthy People interventions are applied. Public Health does not have the infrastructure to understand precisely what works best, for whom, and under what circumstances. A continual process of gathering evidence is needed to marry structured implementation efforts with research. After additional discussion, Dr. Fielding said the Committee should strongly recommend that the Secretary allocate funding for comparative effectiveness research in public health. A Committee member pointed out that The FIW document is missing information about methods to generate the evidence behind recommendations. There will be some topics about which we know very little. Of these, some will be so important that we’ll need to do something regardless of the evidence gap. Others will not be as important, but might be very inexpensive to do. One shouldn’t ask for a lot of evidence if an action isn’t very costly. It is important not to apply a hierarchy of evidence blindly, but to consider the nature and scale of the problem that is being addressed.

A Committee member pointed out that there are some interventions for which it is difficult to show effectiveness (e.g., pertaining to physical disability, functional status). Therefore, if Healthy People 2020 requires proof that an intervention is effective, such groups may be placed at a disadvantage. This issue must be considered carefully. Regarding the use of Quality-adjusted life years (QALYs), not only is measuring quality of life difficult, but there are implicit judgments about quality of life (e.g., for people who are disabled) that we just as a society haven't really dealt with. Until the research and the researchers are sensitive to those kind of issues, QALYs should not trump other levels of evidence. This kind of language could generate concern in disability community.

Another member said he was sympathetic to these concerns and shared some of them, but said that in some cases it is acceptable to use imperfect decision-making tools for the simple reason that you need to make a decision. This does not mean that the tools should override common sense. Dr. Kumanyika noted that the FACA’s evidence paper doesn’t address equity. The issue of QALYs fits in here. The Committee should look through the document and identify places where evidence issues relate to equity. For example, look at magnitude of effect, or make sure that the quality and meaning of measurements and the things that have gone into assessing them, don’t vary for different populations.

Regarding the FIW’s draft recommendations, when talking about the evidence, Dr. Fielding noted that it is important to be extremely careful that we take into account the quality of that evidence. He was concerned that the FIW document seems to suggest that anything that has been cleared by a government agency or has undergone a systematic review qualifies for inclusion in Healthy People. Expert opinion has been wrong. Systematic reviews are also heterogeneous in terms of the methods that are employed. Approval by professional societies may not be an adequate indicator of the quality of evidence. His point was not that none of these approaches should ever be used, but that they are different in terms of the quality of the evidence they provide. He felt it would do a disservice to the Healthy People process if these approaches are all included.

Dr. Fielding cautioned that one must be careful of the penchant for action, which can lead to doing something even when the evidence isn’t there to support that approach. It is insidious to put dollars into something of unknown effectiveness in response to political pressures when there is something else that has been shown to be effective. A member remarked that if something is very inexpensive, one might try it even if it doesn’t have the highest quality of evidence. On the other hand, there is a danger one can break a problem into what appear to be very small bins, and then you just spend a whole bunch of money in every little one of them and you squander it in the end.

Actions sometimes do not happen as the result of a deliberate decision-making process, but unfold simply because people in heath departments are responding to what is being asked of them. In some cases it will be necessary to act, either for political purposes or because the money is there. In such situations, it is important to be clear about the rationale and expectations, and to make sure there is a careful evaluation plan in place. It is critical to foster accountability for improving results, and to educate people about the principles of evidence-based public health practice. There is also the need to be mindful that many advances in population health have occurred through policy, not programs. The best interventions for population health are likely to differ from those for individual health.

To democratize the process, guidelines are needed for people in communities who want to take action, Dr. Fielding said these guidelines may not be based on the same set of criteria for evidence as would be recommended for a public health department that is going to make a large investment, or for elected officials who are going to advocate for a particular policy. The members agreed that they should produce guidelines for what communities should do when they want to take action, but the evidence does not yet exist.

Dr. McGinnis said that in some cases what is needed are not hierarchies of evidence, but hierarchies of implementation. Characteristics of programs should be described in terms of the certainty of results, so that one can say, “This program meets the characteristics for being fully implemented everywhere,” or “This program should only be implemented if funds were set aside to do the evaluation of what we are getting,” or “This program should not be done until we have done pilots in 14 jurisdictions,” or “This program should not be done until we have done better modeling of the potential outcomes.” Such information would guide decision-makers for either programs or policies more specifically about the kinds of issues they should be considering.

A member pointed out that, in developing the evidence, consideration should be given to whether the keeper of that evidence should be the department or someone else, such as the equivalent of the Underwriters’ Laboratory, to keep it separate from the political process and make it easier for communities to be able to access the information. As we move into health reform, this will become much more important. He also remarked on the need for “practice-based evidence,” in addition to evidence-based practice. That is, if activities are being implemented in communities, there must be an avenue for them to communicate about their experiences and gain traction and visibility. The communication should not flow in one direction.

A Committee member commented that she finds the U.S. Preventive Services Task Force guidelines for levels of evidence (A, B, C, and D) helpful. She suggested that the Implementation Subcommittee should explore the needs of the users with regard to understanding the quality of evidence, especially since there will be certain objectives for which evidence is not available at all. “Practice-based evidence” will be important here, in that there may be certain communities where people are interested in helping to generate evidence, perhaps through the use of electronic information systems. This is important because certain populations are systematically excluded from research. Dr. Fielding emphasized that the Committee is not asking people to refrain from acting in the absence of evidence. Another member said there seems to be a need for clarification of the circumstances in which, in the absence of sufficient evidence, one would act anyway. There is a need to write those down and to be clear about them.

Dr. Fielding asked the Committee whether there should there be a vetting process that deals not only with evidence, but with issues of form, prioritization, quality of exposition, and clarity to ensure that all of the topics come together to make a “Healthy People family.” Given the fact that there are many different topics, with different groups of people working on them, he had concerns that the methods used might be inconsistent, and the quality of the product could be uneven. Thus, he wondered whether a vetting process was needed before things are in fact accepted, so that there can be some consistency across topics.

Ms. Blakey said that at the present time, the FIW is immersed in developing and reviewing over a thousand objectives, and they have not yet begun discussing action steps. She said that they had noticed some inconsistencies and are keeping a running list of these issues. The FIW is planning to do a final “sweep” to ensure consistency, and to pare down the number of objectives, after they have finished the objective development. She noted that they are not yet ready to begin looking at action steps, as they would need to have standards that they could use to evaluate them. They are trying to develop this, but it is difficult because the evidence needed for different settings would vary.

Dr. Fielding asked whether it might help to have a group established that includes individuals with experience in the implementation, not just academics but other people with experience in methods, who can help the FIW in real time as part of this vetting process. He expressed concern that the FIW, which is very small group, is trying to do a lot of work. Some help from people outside the government, or from other parts of the government, might be helpful. RADM Slade-Sawyer explained that forming an expert group to vet recommendations would entail providing advice to the government, which would trigger the FACA regulations. She suggested that an alternative approach might be to form a subcommittee to this FACA. Another Committee member asked for a response to the original question, which was whether there need for an additional group. She noted that ODPHP already seems to have a process in place. Ms. Blakey indicated there is not really a need in this area. The clearance process itself will be helpful. Since this process is working, Dr. Fielding said there was no need to make a recommendation in this area.

Dr. Kumanyika returned to this issue later in the discussion. She commented that there is a vetting process for objectives, but said there seems to be a gap between objectives and action strategies. She indicated that throughout its deliberations, the Committee has talked about a process in which “somebody” sits down and puts the whole story of Healthy People 2020 together and uses evidence. She asked whether that process is currently in place. Ms. Blakey responded that a vetting process is currently in place for objectives. With regard to action steps, the FIW is still early in the process, and can change its approach based on feedback. In terms of looking at the whole picture, if there is an objective, one would want to have interventions available to help improve the status of whatever that objective is. The workgroups are doing that, and are presenting evidence in their rationale or justification for submitted objectives.

Dr. Kumanyika thanked Ms. Blakey for this clarification. She explained that she had asked because the Committee’s document on evidence had been designed for the purpose of guiding the process of going from objectives to recommended actions. She asked how the Committee can structure its input so that it can be useful in that process. She noted that the FIW’s document seems designed to serve this purposed, and she hoped to merge the approaches of the FIW and FACA documents. That is a really complicated process. She asked whether the process will be staged in some way, so that one stage will be issuance of the objectives and general guidelines, and then later the evidence-based actions would be released. Ms. Blakey affirmed that this is exactly the process that is planned. They will start with the objectives, and then will add the different tiers of actions, or evidence for action steps.

RADM Slade-Sawyer asked for feedback from the Committee. If the government's role is to issue to the American people the preponderance of the evidence for certain actions, would there be value in having Healthy People move back from having communities put forth information about their work. Such an approach would be a new way of doing getting community input, but should ODPHP proceed with it? A Committee member commented that this type of approach would generate evidence, but there should be weight placed on whether or not that evidence is rigorous. Dr. Fielding commented that the vast majority of community activities will never be evaluated. When you look closely at the quality of the evidence, often you haven’t seen an effect. He advised caution, because there is huge amount of bias. It’s one thing to facilitate dialogue among communities, and quite another thing to recommend it as evidence, which would risk having people invest in ineffective strategies based on anecdotal evidence.

A Committee member recommended “narrowing the universe” of issues being addressed to focus on areas where evidence is going to be extremely difficult to get. If there are areas where they don’t have a high level of evidence but should have it, we should push for that. Other areas (e.g., social determinants) will never be able to go to high-quality experimental or quasi-experimental studies. There is a need to be selective in thinking about areas where experimental evidence may be impractical, but there may be other natural experiment-oriented ways to collect evidence. For example, there can be natural experiments around policy-level interventions that may have a higher-level impact, but are very rarely evaluated. Perhaps those could be evaluated if people knew in advance that they would be happening. Is there a way to focus in on the levels of evidence that we really care about? Additional feedback on the question of whether ODPHP should collect community-level data through an open forum is summarized below.

  • Pulling back from an open forum would be wise, but ODPHP doesn’t have to do this alone. The movement toward evidence-based practices is out there. Healthy People 2020 could put grounding under that movement. The. ARRA funds will create a number of opportunities to generate practice-based evidence.
  • Is HHS the right place to be the main purveyor of evidence, or other possibilities be explored, such as a cooperative effort for accomplishing the same tasks? Where and who has responsibility for overseeing this development? Other than ODPHP, where can we look to take responsibility for this? This could be NIH, CDC, or AHRQ. The Evidence Subcommittee should make recommendations on this issue.

A Committee member noted the need for specific guidelines for what to do when there is no evidence, but people feel compelled to act. A hierarchy of implementation could present crucial issues to be considered in terms of resources, urgency, etc. Dr. Fielding agreed his should be included in the work of the Evidence Subcommittee.

IV. Secretary’s Advisory Committee Process Moving Forward

12:00 PM- 12:30 PM

Dr. Fielding noted that the Committee’s WebEx meetings have been successful. He said that those should continue, and the Committee will leave open the opportunity to have in-person meetings as the necessity arises. If there is a particularly thorny issue that can’t be resolved via telephone calls, or there is a desire on the part of the Secretary or Dr. Koh to convene the Committee for a specific purpose, then in-person meetings could be planned. He asked ODPHP for guidance on how frequently the WebEx meetings should be scheduled and whether it might be possible to move to a schedule of meeting every six weeks.

Ms. Blakey suggested scheduling monthly WebEx meetings, but not all of these dates would need to be used. Dr. Fielding requested that the Committee members be informed at least two weeks in advance if a meeting will not occur, so that they can free their calendars. Also, subcommittee work takes place between meetings of the full Committee, so they need enough time for feedback from the Committee. Web-based meetings will be scheduled for every month and will possibly move to every 6 weeks over time. The Advisory Committee member’s will be surveyed regarding their availability for scheduling WebEx meetings.

Dr. Fielding indicated that the Committee had already discussed their “to-do” list for the year. A Committee member requested that a summary be provided of which subcommittees have completed their current tasks, and what the charges are as the subcommittees move forward. Charges for the new and renewed subcommittees were discussed, and are presented in Exhibit 2.

Dr. Fielding thanked the Committee for their excellent work. He also thanked ODPHP for their deep commitment to Healthy People and the members of the audience who listened to the meeting. He invited those in the audience to submit their comments through the public comment Web site at RADM Slade-Sawyer again thanked the Committee for their extraordinary service over nearly two years and said that the plan is for Healthy People 2020 to be in HHS clearance by spring.

The meeting was adjourned at 12:30 P.M.

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