4

Committee Methodology

This chapter outlines the methodology that the Institute of Medicine Committee on Preventive Services for Women used to identify preventive services necessary for women’s health and well-being that are not included in the United States Preventive Services Task Force (USPSTF) Grade A and B recommendations, Bright Futures’ recommendations, or the Advisory Committee on Immunization Practices (ACIP) guidelines and to identify specific services that could supplement the current list of preventive services recommended for women under the Patient Protection and Affordable Care Act of 2010 (ACA). The committee’s first step in this process was to review and reach an understanding of the guidelines of these analytic bodies. The second step was to assemble and assess additional evidence, including reviews of the literature, federal health priority goals and objectives, federal reimbursement policies, and professional clinical guidelines. The committee also considered comments submitted by the public. Finally, the committee recommended preventive services that the Secretary of the U.S. Department of Health and Human Services (HHS) should consider in developing a comprehensive package of preventive services for women to be included under the ACA.1

REVIEW OF USPSTF RECOMMENDATIONS

The USPSTF process was developed to provide guidance to primary care providers. The committee’s approach to identifying gaps in existing

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1 One committee member’s dissenting comments regarding much of the study process are included in Appendix D.



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4 Committee Methodology This chapter outlines the methodology that the Institute of Medicine Committee on Preventive Services for Women used to identify preventive services necessary for women’s health and well-being that are not included in the United States Preventive Services Task Force (USPSTF) Grade A and B recommendations, Bright Futures’ recommendations, or the Advisory Com- mittee on Immunization Practices (ACIP) guidelines and to identify specific services that could supplement the current list of preventive services recom- mended for women under the Patient Protection and Affordable Care Act of 2010 (ACA). The committee’s first step in this process was to review and reach an understanding of the guidelines of these analytic bodies. The second step was to assemble and assess additional evidence, including reviews of the literature, federal health priority goals and objectives, federal reimbursement policies, and professional clinical guidelines. The committee also considered comments submitted by the public. Finally, the committee recommended preventive services that the Secretary of the U.S. Department of Health and Human Services (HHS) should consider in developing a comprehensive package of preventive services for women to be included under the ACA.1 REVIEW OF USPSTF RECOMMENDATIONS The USPSTF process was developed to provide guidance to primary care providers. The committee’s approach to identifying gaps in existing 1 One committee member’s dissenting comments regarding much of the study process are included in Appendix D. 67

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68 CLINICAL PREVENTIVE SERVICES FOR WOMEN services accounts for contextual issues beyond traditional research evidence used by the USPSTF. The committee looked at women’s preventive service needs more broadly to account for women’s health and well-being. The committee found that the USPSTF Grade A and B recommendations required close examination. The specificity of several recommendations is not clear in some cases, including such details as the periodicity of screenings or how the service is to be delivered. For example, the Grade B recommendation for screening for depression could be interpreted to be universal screening, under the assumption that the primary care provider offices offering the ser- vice have adequate staff in place to support the correct delivery of the service, or the USPSTF’s recommendation could be interpreted narrowly to include screening only in those practices that have a certified depression screening quality assurance program in place. Thus, after a review of the supporting evidence that led to their recommendations, the committee decided that it was important to note its interpretation of the Grade A and B recommenda- tions in those cases in which specific aspects of the recommendation were found to be ambiguous (see Table 5-1). The committee also compared the USPSTF guidelines with the guidelines of other professional organizations to identify potential gaps. The USPSTF Grade C and I statements (Table 4-1) also required further analysis by the committee because in neither case had the USPSTF intended its conclusions to limit or preclude consideration for coverage. The USPSTF informally refers to Grade C recommendations as close calls in which the balance of potential benefits and harms does not strongly favor the clini- cian recommending the preventive service to all patients, although it may be appropriate in some cases. The USPSTF makes the point that either choos- ing or not choosing the service with a Grade C recommendation would be within the standard of care and assumes that the service would be covered if clinically appropriate (USPSTF, 2008). The USPSTF also considers decision making to be a shared activity of the patient and the provider based on the individual circumstances of the patient. The Grade I statement is a conclusion that the evidence is “insufficient to conclude whether the service is effective or not because evidence is lack- ing, of poor quality, or conflicting, and the balance of benefits and harms cannot be determined” (USPSTF, 2008). The I statement simply means that important outcomes have not yet been adequately evaluated by cur- rent research. The committee notes that from a coverage perspective, the evidence supporting many clinical interventions in common use, whether in prevention or in general medical practice, is insufficient or unclear, and that coverage decisions may be made or have been made on the basis of other factors. For example, although knowledge of the evidence for the benefits and harms of services and screenings informs a primary care provider’s

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69 COMMITTEE METHODOLOGY TABLE 4-1 USPSTF Grade C Recommendations and I Statements Topic Description Grade Additional The U.S. Preventive Services Task Force (USPSTF) I risk factors for concludes that the evidence is insufficient to assess the intermediate coronary balance of benefits and harms of using the nontraditional heart disease (CHD) risk factors discussed in this statement to screen risk: screening asymptomatic men and women with no history of CHD to prevent CHD events (select “Clinical Considerations” for suggestions for practice when evidence is insufficient). Avoidance of alcohol The USPSTF concludes that the current evidence is I use counseling insufficient to assess the balance of benefits and harms of routine counseling of all patients in the primary care setting to reduce driving while under the influence of alcohol or riding with drivers who are alcohol-impaired. Back pain: counseling The USPSTF concludes that the evidence is insufficient to I recommend for or against the routine use of interventions to prevent low back pain in adults in primary care settings. Bacterial vaginosis The USPSTF concludes that the current evidence is I screening: pregnant insufficient to assess the balance of benefits and harms women of screening for bacterial vaginosis in asymptomatic pregnant women at high risk for preterm delivery. Breast cancer The USPSTF concludes that the evidence is insufficient I screening to recommend for or against routine clinical breast examination alone to screen for breast cancer. Cervical cancer The USPSTF concludes that the evidence is insufficient I screening to recommend for or against the routine use of new technologies to screen for cervical cancer. Cervical cancer The USPSTF concludes that the evidence is insufficient I screening to recommend for or against the routine use of human papillomavirus (HPV) testing as a primary screening test for cervical cancer. CHD risk assessment The USPSTF concludes that the evidence is insufficient I to assess the balance of benefits and harms of using the nontraditional risk factors discussed in this statement to screen asymptomatic men and women with no history of CHD to prevent CHD events CHD screening The USPSTF found insufficient evidence to recommend I for or against routine screening with resting electrocardiography (ECG), exercise treadmill test (ETT), or electron-beam computerized tomography (EBCT) scanning for coronary calcium for either the presence of severe coronary artery stenosis (CAS) or the prediction of CHD events in adults at increased risk for CHD events. Chlamydial infection The USPSTF recommends against routinely providing C screening: non- screening for chlamydial infection for women aged 25 pregnant women and older, whether or not they are pregnant, if they are not at increased risk. continued

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70 CLINICAL PREVENTIVE SERVICES FOR WOMEN TABLE 4-1 Continued Topic Description Grade Cholesterol The USPSTF makes no recommendation for or against C abnormalities routine screening for lipid disorders in men aged 20 screening to 35, or in women aged 20 and older who are not at increased risk for coronary heart disease. Colorectal cancer The USPSTF concludes that the evidence is insufficient to I screening assess the benefits and harms of computed tomographic colonography and fecal DNA testing as screening modalities for colorectal cancer. Depression screening: The USPTF recommends against routinely screening C adults adults for depression when staff-assisted depression care supports are not in place. There may be considerations that support screening for depression in an individual patient. Diabetes screening The USPSTF concludes that the current evidence is I insufficient to assess the balance of benefits and harms of screening for type 2 diabetes in asymptomatic adults with blood pressure of 135/80 mm Hg or lower. Diet counseling The USPSTF concludes that the evidence is insufficient to I recommend for or against routine behavioral counseling to promote a healthy diet in unselected patients in primary care settings. Drug use screening The USPSTF concludes that the current evidence is I insufficient to assess the balance of benefits and harms of screening adolescents, adults, and pregnant women for illicit drug use. Family violence The USPSTF found insufficient evidence to recommend I screening for or against routine screening of parents or guardians for the physical abuse or neglect of children, of women for intimate partner violence, or of older adults or their caregivers for elder abuse. Gestational diabetes The USPSTF concludes that the evidence is insufficient I screening to recommend for or against routine screening for gestational diabetes. Glaucoma screening The USPSTF found insufficient evidence to recommend I for or against screening adults for glaucoma. Gonorrhea screening: The USPSTF found insufficient evidence to recommend I pregnant women for or against routine screening for gonorrhea infection in pregnant women who are not at increased risk for infection. Hepatitis B screening The USPSTF recommends against routinely screening the I general asymptomatic population for chronic hepatitis B virus infection. Hepatitis C screening The USPSTF found insufficient evidence to recommend I for or against routine screening for HCV infection in adults at high risk for infection.

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71 COMMITTEE METHODOLOGY TABLE 4-1 Continued Topic Description Grade Human immuno- The USPSTF makes no recommendation for or against C deficiency virus (HIV) routinely screening for HIV adolescents and adults who screening are not at increased risk for HIV infection Lung cancer The USPSTF concludes that the evidence is insufficient I screening to recommend for or against screening asymptomatic persons for lung cancer with either low dose computerized tomography (LDCT), chest X-ray (CXR), sputum cytology, or a combination of these tests. Motor vehicle The USPSTF concludes that the current evidence is I restraint counseling insufficient to assess the incremental benefit, beyond the efficacy of legislation and community-based interventions, of counseling in the primary care setting, in improving rates of proper use of motor vehicle occupant restraints (child safety seats, booster seats, and lap-and-shoulder belts). Obesity screening and The USPSTF concludes that the evidence is insufficient to I counseling recommend for or against the use of moderate- or low- intensity counseling together with behavioral interventions to promote sustained weight loss in obese adults. Obesity screening and The USPSTF concludes that the evidence is insufficient I counseling to recommend for or against the use of counseling of any intensity and behavioral interventions to promote sustained weight loss in overweight adults. Oral cancer screening The USPSTF concludes that the evidence is insufficient to I recommend for or against routinely screening adults for oral cancer. Physical activity The USPSTF concludes that the evidence is insufficient I counseling to recommend for or against behavioral counseling in primary care settings to promote physical activity. Sexually transmitted The USPSTF concludes that the current evidence is I infections (STIs) insufficient to assess the balance of benefits and harms counseling of behavioral counseling to prevent STIs in nonsexually- active adolescents and in adults not at increased risk for STIs. Skin cancer The USPSTF concludes that the evidence is insufficient to I counseling recommend for or against routine counseling by primary care clinicians to prevent skin cancer. Skin cancer screening The USPSTF concludes that the current evidence is I insufficient to assess the balance of benefits and harms of using a whole-body skin examination by a primary care clinician or patient skin self-examination for the early detection of cutaneous melanoma, basal cell cancer, or squamous cell skin cancer in the adult general population. Suicide risk screening The USPSTF concludes that the evidence is insufficient to I recommend for or against routine screening by primary care clinicians to detect suicide risk in the general population. continued

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72 CLINICAL PREVENTIVE SERVICES FOR WOMEN TABLE 4-1 Continued Topic Description Grade Thyroid disease The USPSTF concludes the evidence is insufficient to I screening recommend for or against routine screening for thyroid disease in adults. Vitamin The USPSTF concludes that the evidence is insufficient I supplementation for to recommend for or against the use of supplements of disease prevention vitamins A, C, or E; multivitamins with folic acid; or antioxidant combinations for the prevention of cancer or cardiovascular disease SOURCE: USPSTF, 2011. decision for each patient, in many instances, research either is inconclusive or has not been conducted. The Institute of Medicine (IOM) report on women’s health research identified many areas in which research is needed (IOM, 2010). For ex- ample, the report indicated a lack of large-scale studies identifying effective gender- and age-specific interventions involving modification of lifestyle and other behaviors that affect health, such as alcohol abuse and obesity. Furthermore, determining the evidence for the value of certain services is challenging, because it is difficult to prove the effectiveness of an interven- tion across the life span. For example, prevention interventions that should be conducted early in the life span (e.g., skin cancer prevention) require decades to demonstrate effectiveness. Each of the Grade C and I recommendation statements and the evidence supporting them were collected and reviewed. The committee’s evaluation included reviewing relevant supporting USPSTF publications, other peer- reviewed research and clinical articles, and clinician fact sheets. The commit- tee did not reassess the Grade D recommendations, given the evidence base driving the USPSTF to recommend against providing these services. Addi- tional literature searches were conducted to identify randomized control trials that were conducted after the USPSTF recommendation was released for each of the Grade C and I recommendations. Furthermore, the com- mittee compared the Grade C and I guidelines with guidelines from other professional groups. REVIEW OF BRIGHT FUTURES RECOMMENDATIONS The committee reviewed all Bright Futures guidelines and compared them with the USPSTF guidelines for adolescents. The committee noted that the methodology that Bright Futures uses to develop recommendations is considered “evidence informed” and includes expert opinion. Bright

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73 COMMITTEE METHODOLOGY Futures also uses a more comprehensive focus on health promotion and disease prevention, on the basis of its criteria for the burden of the condi- tion (AAP, 2008). For the committee, the principal challenge in identifying preventive ser- vices to supplement the guidance from Bright Futures was to disaggregate the health supervision visits recommended by Bright Futures and some of its anticipatory guidance into conditions and preventive measures fitting the committee’s overall approach. The committee considered the sample questions and advice suggested in the anticipatory guidance section of the Bright Futures report to be preventive services to be covered under the ACA. According to the guidelines, these preventive services should be addressed in an annual visit of sufficient length to cover age- and sex-ap- propriate topics in the health domain. Thus, the topics of physical growth and development, social and academic competence, emotional well-being, risk reduction, and violence and injury prevention, as well as the sample questions and suggested guidance for both the parents and the adolescent, are expected to be addressed at each and every annual visit. The task of addressing each and every one of the suggested topics during a yearly visit seemed daunting to the committee. However, the committee assumes that primary care providers will identify priorities from this section on the basis of the unique circumstances of each patient. REVIEW OF ACIP RECOMMENDATIONS The committee reviewed ACIP General Recommendations on Immu- nization, which include all Food and Drug Administration-approved im- munizations recommended for the general population of adolescent and adult women (CDC, 2011; Smith et al., 2009). In addition, to assess po- tential supplemental immunizations, the committee reviewed the immuni- zations recommended for high-risk groups and for individuals in special circumstances to determine whether some substantial subpopulation of women, clearly defined, might warrant further attention. Although litera- ture searches were conducted to identify areas where supplemental immuni- zation recommendations might be warranted, the committee identified little evidence to indicate clear deficiencies in existing ACIP recommendations. FURTHER COMMITTEE CONSIDERATIONS The committee reviewed both oral and written public comments sub- mitted throughout the course of the study. Some of these comments were from experts, individuals expressing personal experiences with preventable conditions, and members of the U.S. Congress. All of these comments con- tained recommendations for the committee’s consideration. Additionally,

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74 CLINICAL PREVENTIVE SERVICES FOR WOMEN several nongovernmental organizations submitted research studies, public statements, and recommended guidelines for preventive services for women. The committee reviewed all of this information. The committee also invited researchers and leaders of organizations to deliver presentations in areas where the committee believed that it could benefit from their expertise. These included, for example, presentations on mental health, oral health, occupational health, and the perspectives of employers and health insurers. The committee invited speakers who requested the opportunity in addition to inviting individuals with expertise in potential gap areas or individuals identified as having a perspective that the committee should consider. Furthermore, the committee reviewed HHS documents relating to prevention priorities and reimbursement policies. It also reviewed the existing coverage practices of national, state, and private health plans (these are detailed in Chapter 3). In some cases, committee members also identified current practice in clinical care by using sources such as the British Medical Journal Best Evidence and UpToDate (BMJ Clinical Evidence, 2011; UpToDate Inc., 2011). Finally, the committee also used the 2011 IOM report Leading Health Indicators for Healthy People 2020 as a tool to perform horizon scanning or examine priority goals and/ or persistent trends relating to women’s health and well-being to identify potential gaps (IOM, 2011). Committee Analysis The product of these reviews was an array of areas in which supple- mental preventive measures might be warranted. Some of these areas were identified on the basis of traditional indicators such as morbidity and mor- tality, whereas others were more generally identified to be supportive of a woman’s well-being. Adhering to the definitions described in Chapter 1, the committee focused on conditions unique to women or that affect women in some specific or disproportionate way. In general, the committee used crite- ria adapted from the USPSTF that consider frequency, severity, morbidity, mortality, and quality of life to bring consistency to the analyses. For each potential supplemental preventive measure considered, an ex- tensive comparison with the guidelines of professional organizations (e.g., American Academy of Family Physicians, American College of Physicians, American College of Obstetricians and Gynecologists, American Cancer Society, American Medical Association) was conducted to understand these guidelines development processes and the evidence that the organizations use to reach their conclusions. Many of these guidelines are posted in the Agency for Healthcare Research and Quality’s National Guidelines Clear- inghouse. The committee also performed targeted literature searches.

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75 COMMITTEE METHODOLOGY Identifying Potential Supplemental Preventive Measures The committee then attempted to identify preventive measures that were aimed at filling the gaps that it had identified. In most cases, the committee found that measures had already been proposed by the other organizations mentioned above. The committee also eliminated preven- tive measures that, even at this early stage in the analysis, were clearly not developed, tested, or known well enough to have a measurable impact. The resulting product of this step was a series of areas with gaps, with the accompanying preventive measure or measures that could be considered by the Secretary for HHS for inclusion in guiding policy and program develop- ment relating to the ACA. Identifying Gap Areas and Measures with Adequate Evidence The core of the committee’s task was to assemble the evidence that would allow it to recommend consideration of a preventive service. The committee found that systematic reviews of clinical effectiveness were not available to address all the potential gaps and that a standard methodology addressing coverage of preventive services does not exist. These two issues are discussed below. Reviews of Clinical Effectiveness Assessment of the efficacy and effectiveness of preventive measures to provide clinical guidance was one of the topics of clinical focus that, more than 30 years ago, launched the change in the approach to health care delivery that is now called evidence-based medicine. The USPSTF and its Canadian sister organization, the Canadian Taskforce on Preventive Health Care, were active at the beginning of this movement, with a major focus being on developing the methodology. Since the 1980s, the standards for judging the effectiveness of preventive measures have matured, and the bar for determining the effectiveness of preventive measures has been set very high. Furthermore, for a number of reasons, including ethical constraints, the evidence bar is usually set higher for preventive services than for the services offered in many other areas of conventional medical care. It is generally assumed that a preventive service intended for the general popu- lation should have proven benefits and minimal harms, with the benefits clearly outweighing the harms. As noted below, the committee had neither the time and resources nor a charge to conduct its own systematic reviews, which, using the USPSTF as an example, often take 12 to 18 months for a single topic.

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76 CLINICAL PREVENTIVE SERVICES FOR WOMEN Methodologies with a Coverage Decision as the Goal The USPSTF, Bright Futures, and ACIP focus on the provision of guid- ance to clinicians and patients, not on insurance coverage. Decision making about covering a preventive service may consider a host of other issues, such as established practice; patient and clinician preferences; availability; ethical, legal, and social issues; and availability of alternatives. Further com- plicating matters, special population groups, such as minority populations, recent immigrants, lesbians, prisoners, and those employed in high-risk environments, may have different health needs or benefit from different preventive services. In addition, high-risk groups, population subsets, and special populations are unevenly identified and are addressed at varying de- grees in current guidelines. Finally, because cost was explicitly excluded as a factor that the committee could use in forming recommendations, the com- mittee process could not evaluate preventive services on the basis of cost. Against this background, the committee selected a hybrid approach that collected relevant evidence for each measure, and it determined that the question of a methodology to fully address insurance coverage was beyond its scope. Four categories of evidence—posed in the form of ques- tions—were developed to systematically query support for each potential preventive measure. The committee neither formally ranked or assigned weights to the categories, nor did it stipulate that evidence in any one cat- egory would automatically result in a recommendation for a measure or service to be considered. Instead, the queries and categories were used to consider the range of evidence and to ensure consistency in the committee’s analysis and deliberations. Many of the recommendations are supported by more than one category of evidence. Category I. Are high-quality systematic evidence reviews available in- dicating that the service is effective in women? Category II. Are quality peer-reviewed studies available demonstrating effectiveness of the service in women? Category III. Has the measure been identified as a federal priority to address in women’s preventive services? Category IV. Are there existing federal, state, or international practices, professional guidelines, or federal reimbursement policies that sup- port the use of the measure?

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77 COMMITTEE METHODOLOGY RECOMMENDATIONS ON PREVENTIVE SERVICES TO BE CONSIDERED IN DEVELOPMENT OF COMPREHENSIVE GUIDELINES Subcommittees queried the available evidence applicable to potential preventive measures and assigned the evidence to one or more of the catego- ries listed above. Each subcommittee then brought its analysis of the range of evidence before the full committee for deliberation. The committee com- bined the burden of the condition and its potential impact on health and well-being with the array of available evidence and support noted above to come to a consensus over whether to recommend that a specific preventive measure be considered by the Secretary. As is true in most analytical pro- cesses in decision making, evidence and expert judgment are inextricably linked; thus, the expert judgments of the committee members also played a role in decision making. In general, preventive measures recommended by the committee met the following criteria: • The condition to be prevented affects a broad population; • The condition to be prevented has a large potential impact on health and well-being; and • The quality and strength of the evidence is supportive. Ultimately, the decision to develop a recommendation for a preventive measure or service was made after a thoughtful review and debate of each of the subcommittee’s reports. Recommendations were made when the evidence was found compelling based on the committee’s interpretation of the strength of the evidence. In Chapters 5, the committee describes the evidence that factored into its decision making for each supplemental pre- ventive measure recommendation. In some instances, a subcommittee’s analysis resulted in the develop- ment of a clarifying statement (added to Table 5-1) on the committee’s interpretation of current USPSTF guidelines. In other cases, the subcom- mittee’s analysis suggested a service that could be considered part of a well- woman visit (Table 5-6). These are addressed in Appendix A of this report. REFERENCES AAP (American Academy of Pediatrics). 2008. Bright Futures: Guidelines for health super- vision of infants, children and adolescents, 3rd ed. (J. F. Hagan, J. S. Shaw, and P. M. Duncan, eds.). Elk Grove Village, IL: American Academy of Pediatrics. BMJ Clinical Evidence. 2011. Clinical evidence. London, United Kingdom: BMJ Publishing Group.

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78 CLINICAL PREVENTIVE SERVICES FOR WOMEN CDC (Centers for Disease Control and Prevention). 2011. General recommendations on immunization—recommendations of the Advisory Committee on Immunization Prac- tices (ACIP). MMWR Recommendations and Reports: Morbidity and Mortality Weekly Report 60(2):1–64. IOM (Institute of Medicine). 2010. Women’s health research: Progress, pitfalls, and promise. Washington, DC: The National Academies Press. IOM. 2011. Leading health indicators for Healthy People 2020. Washington, DC: The Na- tional Academies Press. Smith, J. C., D. E. Snider, and L. K. Pickering. 2009. Immunization policy development in the United States: The role of the Advisory Committee on Immunization Practices. Annals of Internal Medicine 150(1):W45–W49. UpToDate Inc. 2011. UpToDate. Waltham, MA: UpToDate Inc. USPSTF (United States Preventive Services Task Force). 2008. Grade definitions. Rockville, MD: United States Preventive Services Task Force. http://www.uspreventiveservicestaskforce.org/ uspstf/grades.htm (accessed May 31, 2011). USPSTF. 2011. A-Z topic guide. Rockville, MD: United States Preventive Services Task Force. http://www.uspreventiveservicestaskforce.org/uspstopics.htm (accessed May 31, 2011).