4

Community Prevention Study

INTRODUCTION

NIH has not provided a clear vision for the Community Prevention Study (CPS). The hypotheses for this component of the Women's Health Initiative (WHI) are less specific than those of the Clinical Trial (CT); the rationale, design, and methods are incompletely described. Only an initial plan for the CPS has been presented thus far, and consequently the committee is unsure of the scope of the CPS or the resources necessary to complete it. Nevertheless, the committee is supportive of the concept presented in the 1992 WHI Concept Review Document to develop practical community-based strategies needed to achieve many national goals for women's health.

NIH representatives discussed plans for the CPS during the committee 's June 1993 meeting, but no firm plans or cost estimate were provided. The committee estimates that between $25 and $50 million of the funds allocated for the WHI may be available to fund the CPS. This was calculated by subtracting the current cost estimates of the CT and OS from the total available WHI monies of $625 million. In considering the tremendous need for strategies that would result in lifestyle change in women, particularly among lower socioeconomic status (SES) and minority women, the committee feels that an amount as low as $25 million will not suffice.

RATIONALE

The WHI Concept Review Document pertaining to the Community Prevention Studies (March 9, 1992) states that there are two major purposes for the WHI. The CT is designed to test hypotheses, and the OS is designed to either generate or support hypotheses, but neither is designed to develop methods for implementing the recommendations that might ensue from the trials. These implementation methodologies are to be the province of the third major component of the WHI: the community study. Originally termed the Community Randomized Trial (CRT), this trial was reconceptualized in June 1993 and is now called the Community Prevention Study (CPS). The CPS is currently under development; a consultant's meeting was held on July 19, 1993, and a concept review meeting is scheduled for later in 1993.



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An Assessment of the NIH Women's Health Initiative 4 Community Prevention Study INTRODUCTION NIH has not provided a clear vision for the Community Prevention Study (CPS). The hypotheses for this component of the Women's Health Initiative (WHI) are less specific than those of the Clinical Trial (CT); the rationale, design, and methods are incompletely described. Only an initial plan for the CPS has been presented thus far, and consequently the committee is unsure of the scope of the CPS or the resources necessary to complete it. Nevertheless, the committee is supportive of the concept presented in the 1992 WHI Concept Review Document to develop practical community-based strategies needed to achieve many national goals for women's health. NIH representatives discussed plans for the CPS during the committee 's June 1993 meeting, but no firm plans or cost estimate were provided. The committee estimates that between $25 and $50 million of the funds allocated for the WHI may be available to fund the CPS. This was calculated by subtracting the current cost estimates of the CT and OS from the total available WHI monies of $625 million. In considering the tremendous need for strategies that would result in lifestyle change in women, particularly among lower socioeconomic status (SES) and minority women, the committee feels that an amount as low as $25 million will not suffice. RATIONALE The WHI Concept Review Document pertaining to the Community Prevention Studies (March 9, 1992) states that there are two major purposes for the WHI. The CT is designed to test hypotheses, and the OS is designed to either generate or support hypotheses, but neither is designed to develop methods for implementing the recommendations that might ensue from the trials. These implementation methodologies are to be the province of the third major component of the WHI: the community study. Originally termed the Community Randomized Trial (CRT), this trial was reconceptualized in June 1993 and is now called the Community Prevention Study (CPS). The CPS is currently under development; a consultant's meeting was held on July 19, 1993, and a concept review meeting is scheduled for later in 1993.

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An Assessment of the NIH Women's Health Initiative The rationale that distinguished the CRT, as originally designed, from the CT was the “second major purpose” of the WHI: “to evaluate strategies to achieve healthful behaviors including improved diet, smoking prevention and cessation, increased physical activity, and early disease detection, for women of diverse ethnic groups and socioeconomic strata.” The description of the CRT makes it clear that the study was designed to address the broad social and political context of the risk factors under examination. These activities were have to been consistent with the health promotion and disease prevention objectives of Healthy People 2000, with a practical emphasis on the dearth of strategies to achieve those objectives. Furthermore, the CRT planners identified the prior successes of comprehensive community-based programs and the diverse strategies that communities implement as a further rationale for the trial. The original CRT design involved a multicenter field trial in which 16 pairs of communities would be randomized to a set of community interventions. The target age group was women over 40, and sample sizes and power calculations were based on an assumed five years of intervention. Interventions were to be directed at smoking prevention and cessation, dietary pattern, physical activity, and early disease detection for cervical and breast cancer. The CRT 's goal, in addition to “promoting a lifestyle of healthful behavior in women 40 and older, ” was to establish and reinforce the infrastructure through which to promote women's health so that the infrastructure would remain at a functioning level following study completion. The rationale of the redesigned community study, now called the Community Prevention Study (CPS), appears to be similar to the CRT with respect to developing strategies to change the risk factors and health habits relevant to various major chronic diseases of women. This objective is to be achieved, according to NIH, by a series of Requests for Applications. The CPS differs from the CRT in its emphasis on encouraging study of strategies that need development before they are suitable for universal use in multiple communities. The CPS emphasizes the existence of major gaps in diet, exercise, and smoking change programs for women in general, and especially for low-SES and ethnic minority women. This change in rationale rests in part on a changed belief within NIH that a formal randomized trial in 32 communities (the original plan) was premature, and that methods to achieve change in various components of a broad multifactor community trial needed development before they were placed in a formal randomized design. DESIGN AND METHODS The rather sketchy June 1993 design of the CPS suggests a similarity to its CRT predecessor in its language regarding the overall method of community intervention. It differs in its call for pilot studies to evaluate the methodology and feasibility of these interventions. Although the methodology for the project has not yet been formally defined, the Committee has several suggestions:

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An Assessment of the NIH Women's Health Initiative Project selection should ensure that components are suitable for incorporation into comprehensive community-based programs. Projects should attempt to decrease unfavorable disparities between lower SES and racial/ethnic minority women and higher SES non-minority women and to promote the creation of culturally appropriate strategies at low cost. Projects should include strong training components (which will permit personnel to train others in additional communities), possibly resulting in a set of regional training centers. Projects should employ many process measures needed for cost-effectiveness analyses. Projects that are multifactor in both risk factors and targeted methods of intervention should be favored. In addition, projects should include attention to regulatory and environmental changes when feasible; however, more limited and often single-factor projects may provide useful information yet be lacking in the environmental or regulatory change dimension. The CPS should also emphasize projects that promote the creation of culturally appropriate strategies at low cost. Comparisons among strategies can yield much needed data on cost-effectiveness. COST If the CPS is to encompass geographic differences, ethnic minority needs, needs related to SES, many health topics and risk factors, and a variety of strategies to address all of these issues, then a reasonably large number of projects would be necessary. A matrix of target groups, risk factors, and strategies would easily justify 50 projects. As mentioned in the CT cost section in Chapter 2, if additional Clinical Centers are funded at $8 or $9 million each, approximately $570 to $580 million of the $625 million total has been committed for the CT and OS before consideration of funding the CPS (a total remainder of only $45-55 million). However, if the additional Clinical Centers is more expensive than expected, and the total funding necessary for the CT and OS is $600 million, an even lower $25 million would be reserved for the CPS. RECOMMENDATIONS The committee endorses the general plans described to date for the CPS, and NIH is to be commended for creating the concept of multiple RFAs under a cooperative agreement. This will allow the development of the many strategies for change that are needed to fill the gaps in women's health, particularly those that relate to low-SES and minority women. These strategies are needed to achieve various lifestyle changes and the goals of Healthy People 2000; thus, the CPS is separate from and complementary to the CT. The committee therefore makes the following recommendation:

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An Assessment of the NIH Women's Health Initiative The development of the Community Prevention Study should be equal importance with the CT and OS. The committee recommends that NIH consider it a matter of some urgency to develop a more definitive plan for the CPS. The level of resources allocated for the CPS should be an affirmative decision, one that is based on the appropriate funding necessary to accomplish the task, not one obtained through what might be left over from the other two components of the WHI. The committee also feels that certain aspects of the CPS are critical to highlight, and urges the NIH to seriously consider the following suggestions: Given the importance of women's health and the vast range of circumstances influencing it, fund numerous projects (probably between 40 and 50) over approximately eight years. These projects should adequately encompass needs related to diversity of health topic; intended recipients of interventions; geographic regions of varied cultures; and approach or strategy. Within the eight-year project, three years of funding is recommended in order to focus on strengthening infrastructure development and dissemination techniques. Target approximately $50 to $100 million for the CPS. Develop NIH internal resources in conjunction with the coordinating and disseminating functions related to the CPS. In general, NIH should strengthen its public health and disease prevention component; the coordination and dissemination activities of the CPS can aid NIH in reaching that goal. Ensure that a mechanism (such as comparable data collection instruments) exists to link the projects and facilitate useful exchanges among investigators. This would also serve to transfer knowledge and technology to relevant communities during a later dissemination phase. The cooperative agreement is considered as a possible mechanism for this purpose.