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Social Determinants as a Preventive Service: U.S. Preventive Services Task Force Methods Considerations for Research
RESEARCH METHODS
Social Determinants as a Preventive Service: U.S. Preventive Services Task Force Methods Considerations for Research Alex H. Krist, MD, MPH,1 Karina W. Davidson, PhD, MASc,2 Quyen Ngo-Metzger, MD, MPH,3 Justin Mills, MD, MPH3
The body of research on social determinants of health is rapidly accumulating. The U.S. Preventive Services Task Force is conducting evaluations to consider the inclusion of screening and counseling for social risks as a clinical preventive service. Yet, for many social risks, evidence is still likely needed before the U.S. Preventive Services Task Force can recommend universal screening or counseling. This manuscript offers a brief review of the social determinants of health that may be germane to the U.S. Preventive Services Task Force, the methods the U.S. Preventive Services Task Force uses to evaluate relevant evidence, and current evidence gaps for social risks. Key methods for making clinical preventive service recommendations are applied for considering the integration of social and clinical care. These methods include determining the certainty of the evidence, assessing the net benefit, defining appropriate prevention frameworks, defining health outcomes versus intermediate outcomes, fully assessing the harms, and defining to what populations and care contexts the evidence applies. This road map for research is intended to spark ingenuity and purpose in the next generation of research studies, thereby ensuring that future recommendations to address and prevent social risks in primary care are informed by high-quality evidence.
Supplement information: This article is part of a supplement entitled Identifying and Intervening on Social Needs in Clinical Settings: Evidence and Evidence Gaps, which is sponsored by the Agency for Healthcare Research and Quality of the U.S. Department of Health and Human Services, Kaiser Permanente, and the Robert Wood Johnson Foundation. Am J Prev Med 2019;57(6S1):S6−S12. © 2019 American Journal of Preventive Medicine. Published by Elsevier Inc. This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).
INTRODUCTION
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here is a pressing need to address health disparities caused by adverse social determinants of health (SDH). Calls to integrate social and clinical care have been issued by the National Academies of Medicine, WHO, and many others.1−3 Clearly, gender, race, social class, poverty, and other social variables have significant influences on health and well-being. Effectively addressing adverse SDH could potentially save more lives than further medical advances.4 One possible solution is for primary care clinicians to screen and counsel for social risks.5 The U.S. Preventive Services Task Force (USPSTF) has assembled a workgroup to develop a road map on how the USPSTF might approach and prioritize addressing SDH as S6
a clinical preventive service. The workgroup consists of members from the USPSTF, Evidence-based Practice Centers, the Agency for Healthcare Research and Quality, and additional topic experts. The workgroup is considering the SDH definitions to be employed by the USPSTF, domains and components of SDH currently incorporated into existing recommendations, SDH domains and components From the 1Department of Family Medicine and Population Health, Virginia Commonwealth University, Richmond, Virginia; 2Department of Medicine, Northwell Health, New York, New York; and 3Center for Evidence and Practice Improvement, Agency for Healthcare Research and Quality, Rockville, Maryland Address correspondence to: Alex H. Krist, MD, MPH, 830 East Main St, Room 631, Richmond VA 23219. E-mail: [email protected]. 0749-3797/$36.00 https://doi.org/10.1016/j.amepre.2019.07.013
Am J Prev Med 2019;57(6S1):S6−S12 © 2019 American Journal of Preventive Medicine. Published by Elsevier Inc. This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).
Krist et al / Am J Prev Med 2019;57(6S1):S6−S12
relevant to clinical preventive services, which SDH may have more evidence available for review and consideration, how to consistently address SDH in evidence reviews and recommendation statements, and novel methods needed to better evaluate SDH evidence. However, there are significant evidence gaps in determining whether clinicians should screen every patient for social needs.6,7 Before integrating social care into clinical care, it is not enough to merely know that having a social risk is detrimental for health. Validated instruments are needed to identify who has a social risk, effective interventions and actions to address social risks,8,9 evidence that finding social risks early and addressing them in health care improves health outcomes, and finally, an understanding of the potential harms for patients and clinicians. High-quality evidence is needed to recommend any clinical preventive service. Prevention recommendations apply to broad segments of the population that are healthy or have unrecognized conditions. A new prevention recommendation becomes an expectation for care. It has workflow implications, can change the very nature of clinician −patient interactions, and demands necessary infrastructure to support routine delivery. Preventive services often become alerts in electronic medical records and quality measures that clinicians strive to improve. These efforts consume time, resources, and attention. The USPSTF is an independent body and has wellestablished methods for assessing the primary evidence to understand the certainty of the evidence and the net benefit of preventive services.10,11 From this assessment, the USPSTF issues guidelines on preventive care that can be delivered in or referred to by primary care. Although others make guideline recommendations as well, they may use different methods (e.g., also include professional opinion), consider different levels of evidence (e.g., include studies with greater risk of bias), or target different audiences (e.g., the Community Preventive Services Task Force considers interventions that can be delivered by communities). Accordingly, though the USPSTF considers other reviews, it commissions its own evidence reviews. This article considers the unique issues with integrating social and clinical care within the context of the USPSTF recommendation framework. This can provide a roadmap to help inform the design and types of studies needed to assess the value of integrating social care into clinical care.
DEFINING SOCIAL DETERMINANTS OF HEALTH 12−15
There are multiple definitions for SDH. For example, Healthy People 2020 defines SDH as “conditions in the environments in which people are born, live, learn, work, play, worship, and age that affect a wide range of health, December 2019
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functioning, and quality-of-life outcomes and risks.” As the USPSTF considers expanding its recommendations to include SDH, the USPSTF reviewed the many differing definitions and domains of SDH proposed by multiple authors, agencies, and societies. The USPSTF then decided to initially consider the domains included in the Centers for Medicare and Medicaid Services’ (CMS) Accountable Health Communities Model.16 Their 5 core SDH domains are housing instability, food insecurity, transportation difficulties, utility assistance needs, and interpersonal safety.17 The CMS is conducting a demonstration in 31 sites nationwide, focusing first on these 5 core domains thought to be intervenable or modifiable. Their final SDH screening tool also includes 8 supplemental domains: financial strain, employment, family and community support, education, physical activity, substance use, mental health, and disabilities. These 13 domains are a comprehensive start for consideration by the USPSTF; there are plans to consider other domains in later stages.
CURRENT U.S. PREVENTIVE SERVICES TASK FORCE RECOMMENDATIONS To date, the USPSTF has reviewed the evidence and made recommendations for the CMS core SDH domain of interpersonal safety—specifically for intimate partner violence and child maltreatment (Table 1).18−20 There are also recommendations for some of the CMS supplemental SDH domains including 9 health behaviors and 3 mental health topics. The fact that the USPSTF has not evaluated whether to screen for other SDH domains is neither a recommendation for nor against screening. The USPSTF has not reviewed the evidence for these topics because some SDH were not considered a clinical preventive service, and some had a paucity of evidence. For example, although the neighborhood of residence and its built environment are both very important SDH, the USPSTF considers these out of scope because primary care interventions would likely have limited effect on where a patient resides. These particular SDH may be considered in scope for the Community Preventive Services Task Force to examine rather than the USPSTF.21 However, the field is rapidly changing, and advances may allow for consideration of more SDH as clinical preventive services.
SOCIAL DETERMINANTS OF HEALTH RESEARCH METHODS CONSIDERATIONS Multiple evidence gaps need to be addressed before recommending clinical preventive services to address SDH. An overview of the general evidence needs is highlighted in Table 2.
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Table 1. USPSTF Recommendations Addressing Social Determinants of Health Title
Year
Recommendation
Screening for IPV, elder abuse, and abuse of vulnerable adults
2018
Primary care interventions to prevent child maltreatment
2018
The USPSTF recommends that clinicians screen women of childbearing age for IPV, such as domestic violence, and provide or refer women who screen positive to intervention services. (Grade: B recommendation) The USPSTF concludes that the current evidence is insufficient to assess the balance of benefits and harms of screening all elderly or vulnerable adults (physically or mentally dysfunctional) for abuse and neglect. (Grade: I statement) The USPSTF concludes that the current evidence is insufficient to assess the balance of benefits and harms of primary care interventions to prevent child maltreatment. (Grade: I statement)
Note: Additional recommendation statements about Modifiable Health Behaviors included in some definitions of social determinants: Screening and Behavioral Counseling Interventions to Reduce Unhealthy Alcohol Use in Adolescents and Adults (B recommendation in 2013); Screening for Drug Use in Adolescents and Adults, Including Pregnant Women (I recommendation in 2008); Primary Care Behavioral Interventions to Reduce Illicit Drug and Nonmedical Pharmaceutical Use in Children and Adolescents (I recommendation in 2014); Behavioral and Pharmacotherapy Interventions for Tobacco Smoking Cessation in Adults, Including Pregnant Women (A recommendation in 2015); Primary Care Interventions to Prevent Tobacco and Nicotine Use in Children and Adolescents (B recommendation in 2013); Behavioral Counseling to Promote a Healthful Diet and Physical Activity for Cardiovascular Disease Prevention in Adults with Cardiovascular Risk Factors (B recommendation in 2014); Behavioral Counseling to Promote a Healthful Diet and Physical Activity for Cardiovascular Disease Prevention in Adults Without Known Risk Factors (C recommendation in 2017); Behavioral and Pharmacotherapy Weight Loss Interventions to Prevent Obesity-Related Morbidity and Mortality in Adults (B recommendation in 2018); Screening for Obesity in Children and Adolescents (B recommendation in 2017). Additional recommendation statements about Mental Health included in some definitions of social determinants: Screening for Depression in Adults (B recommendation in 2016); Screening for Depression in Children and Adolescents (B recommendation in 2016); Interventions to Prevent Perinatal Depression (new topic under review). IPV, intimate partner violence; USPSTF, U.S. Preventive Services Task Force.
Certainty and Net Benefit Every USPSTF recommendation is based on 2 critical assessments: (1) the certainty of the evidence and (2) the net benefit of the preventive service.22 An example analytic framework for a screening preventive service is shown in Figure 1. Evidence is needed either
for the “direct evidence pathway” (often called Key Question 1 [KQ1]) or for each key question in the “indirect evidence pathway.” In the direct evidence pathway, studies randomize a population to either receive screening or not and then measure all potential benefits and harms from the screening and treatment
Table 2. Evidence Needs for Integrating Clinical and Social Care USPSTF methods principle Certainty Net benefit
Prevention framework
Outcomes
Harms Population
Context
Evidence needs Conduct more studies to increase certainty when assessing benefits and harms Field more RCTs, particularly to assess interventions and direct evidence (KQ1) Conduct more direct (KQ1) evidence studies that compare those offered a screening or counseling versus not offered Develop and test interventions to address social risks that are feasible to deliver in or referable to by primary care Test whether the ideal approach is as a screening service or counseling service Test whether screening or counseling is about addressing any or all social risks versus specific social risks Determine if offering screening or counseling to all patients (preventive service) is better than just when there is a need (case finding) Determine if screening or counseling in the clinical setting adds anything to addressing social risks primarily through social services agencies Better understand the mechanisms of how addressing social risks can lead to improved health outcomes Develop accepted health outcomes for social care Develop accepted thresholds for when a health outcome change is significant Evaluate the linkage between potential intermediate outcomes for social risks and health outcomes Evaluate the full range of harms for integrating social and clinical care including anxiety, unintended consequences, labeling, unmet expectations, opportunity costs, stigma, and legal consequences Determine the social risks of different populations Determine which interventions are effective at addressing social risks in different populations Assess the applicability of screening or counseling evidence to a range of patient populations Understand how the patient, community, clinical, and service context influences the certainty and net benefit of screening or counseling
KQ, key question; USPSTF, U.S. Preventive Services Task Force.
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Figure 1. USPSTF analytic framework for a generic screening test. Note: KQ1 represents the direct evidence pathway. KQ1: Is there evidence that randomizing patients to screening or not screening results in improved length or quality of life? The indirect evidence pathway is evaluated by linking the assessments of KQ2 through KQ8. KQ2: Who are the persons at risk for the condition? KQ3: What are the performance characteristics of the screening test? KQ4: Does treatment of the screen-detected condition result in improved intermediate outcomes? KQ5: Does treatment of the screen-detected condition result in reduced morbidity and mortality? KQ6: Does an improvement in intermediate outcomes lead to improved health outcomes? KQ7: What are the harms associated with screening for the condition? KQ8: What are the harms associated with treating the condition? KQ, key question; USPSTF, U.S. Preventive Services Task Force.
process. The indirect evidence pathway involves linking a series of studies that define the population of interest (KQ2), assessing the accuracy (KQ3) and harms (KQ7) of the screening test, evaluating the benefits (KQ4 and KQ5) and harms (KQ8) of treatments once a condition is identified, and determining the effect on health outcomes (KQ5 and KQ6). When assessing certainty, RCTs are the most effective study design for limiting the risk of bias. This is particularly true for KQ1, KQ4, and KQ5 studies. Other key questions often require other types of study designs—sensitivity and specificity designs for understanding screening test characteristics (KQ3) or observational cohort studies for understanding harms (KQ7 and KQ8). Both certainty and net benefit can be assessed directly from KQ1 studies, whereas assessing the indirect evidence pathway involves assessing the evidence quality for each key question and also the ability to link the evidence across the key questions.22 There are few, if any, KQ1 studies that randomize patients to be screened or not to be screened for a social risk. Even the USPSTFrecommended service, screening for intimate partner violence, lacks KQ1 evidence and relies on the indirect evidence pathway.23 When thinking about the current state of evidence about SDH, there is often clear evidence that having the social risk leads to poor health, and frequently there are validated screening instruments that can identify need for interventions.17,24,25 Commonly missing is evidence for effective interventions that are feasible to deliver in or referable to from primary care.25
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Prevention Framework Research is needed to define the nature of an SDH clinical preventive service. Many presuppose that the most appropriate way to provide the SDH service is as a screening service—ask patients about whether they have a social risk and counsel or support those who screen positive (Figure 1). Alternatively, an SDH service could be considered more when using the USPSTF counseling framework. For this approach, all appropriate patients would receive counseling to prevent or ameliorate the social risk (Figure 2). Using food insecurity as a hypothetical example, the screening framework would involve asking patients if they are experiencing food insecurity and then providing an intervention to those who respond positively. Whereas conceived as a counseling service, all individuals in an atrisk group (e.g., all families with younger children or all individuals on Medicaid) might receive information and support to improve access to healthy food options, irrespective of whether a risk is identified. Each approach has unique advantages and disadvantages that would need to be considered when designing and evaluating the preventive service. Complicating matters is whether the preventive service is about addressing any or all social risks versus addressing a specific social risk. To date, the USPSTF has conceptualized SDH as a screening service for a specific social risk (i.e., intimate partner violence or child maltreatment). Alternatively, some have hypothesized that there may be a single question or set of questions that could indicate the presence of any or all social risks. Patients who have
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Figure 2. USPSTF analytic framework for a generic counseling service. Notes: KQ1 represents the direct evidence pathway. KQ1: Is there direct evidence that behavioral or counseling interventions reduce disease morbidity or mortality? The indirect evidence pathway is evaluated by linking the assessments of KQ2 through KQ5. KQ2: What is the target group? KQ3: Does the behavioral or counseling intervention result in a change in intermediate behavioral or other outcomes? KQ4: Does the intermediate outcome or behavior change lead to reduced morbidity or mortality? KQ5: What are the harms associated with the behavioral counseling intervention for the condition? KQ, key question; USPSTF, U.S. Preventive Services Task Force.
1 social risk are likely to have multiple social risks. Screening and interventions may have to address a range or bundle of potential risks to be effective. Understanding the right approach will be critical for the field. Additionally, evidence is needed to demonstrate whether providing an SDH preventive services is better than case finding. With case finding, clinicians might only assess for a social risk when they have a concern, when risks are identified as part of a history or exam, or when patients mention needs. Case finding may be more effective than systematically screening all patients. For example, providing free transportation vouchers to patients only when the clinician identifies or the patient brings up a need may be more efficient than providing all patients with a voucher, regardless of need, or even screening all patients for transportation needs. Conversely, patients may be hesitant to bring up social risks or may not think that their clinician can help them. Screening or counseling may be necessary to identify and help those at risk and reduce the stigma with selectively addressing SDH. It is also unclear the degree to which SDH should be identified and addressed in primary care, or whether risks should primarily be addressed by public health and social service agencies. These organizations often have addressing social needs as their primary focus, and they may have skills and resources not available or referable to by primary care. Integrating the delivery of social and clinical care may create inefficiencies and divert limited resources from those who can better help patients. For example, if addressing social care is set up as part of a healthcare business, generating profits could take away from providing social services. Conversely, the clinical setting may bring new resources that can be used to address risks, help to identify those at risk, better direct those with risks to the right care, and positively reinforce assistance. A multifaceted approach with linkages between primary care and community resources could increase the effectiveness of interventions and improve outcomes for patients.
Outcomes Before recommending any preventive service, the USPSTF requires evidence that the service improves health outcomes and not just intermediate outcomes. The USPSTF defines a health outcome as improved quality or length of life, and it defines intermediate outcomes as pathologic, physiologic, psychological, social, or behavioral measures.26 Intermediate outcomes are differentiated from health outcomes in that health outcomes are experienced by the patient. For intimate partner violence, screening and subsequent interventions have been shown to reduce physical and mental harms, both of which are considered health outcomes, hence the USPSTF found that the evidence was adequate to recommend screening. Evidence is needed that clearly links whether addressing SDH improves health outcomes. This could occur through several pathways. First, screening and counseling for a social risk may help patients better manage their chronic conditions and thus prevent hospitalizations, complications, and even death. For example, financial strain might lead to limited adherence to treatment plans and preventive cardiovascular medications because of out-ofpocket costs. Interventions to decrease cost might ensure that a patient can take the medication that has been shown to prevent premature morbidity and death. Second, screening and counseling might also improve clinician or patient decisions, understanding, and communication.27 For example, identifying a patient with lower health literacy could be used to tailor the type of decision aid or educational material that might be used with a patient to make an important health decision, like screening for prostate cancer or deciding on the most appropriate surgical approach for early stage breast cancer. Third, knowing the social risks a patient is experiencing may help clinicians better tailor treatment. When helping to develop a weight loss program for a patient with obesity and prediabetes, knowing financial, transportation, or time constraints can change what a clinician recommends for a patient.
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Krist et al / Am J Prev Med 2019;57(6S1):S6−S12 Fourth, addressing the social risk itself could result in improved quality of life, which the USPSTF considers a primary health outcome. Interventions to prevent child maltreatment or counseling to prevent perinatal depression exemplify such a direct path to improved health.20,28 For SDH, needed information includes (1) a better understanding about which outcomes are health outcomes and which are intermediate outcomes, (2) evidence that clearly links intermediate outcomes to health outcomes, (3) an understanding about the thresholds of change that are clinically meaningful, and (4) study designs that can address the impacts on health outcomes.
Future Directions
Harms
ACKNOWLEDGMENTS
In addition to understanding beneficial outcomes, evidence is needed to truly understand the harms of screening and counseling for social risks.6 Identifying a social risk during the clinical encounter can increase stress, anxiety, and unhappiness because patients and clinicians struggle to address a social risk that may be difficult to change. Labeling has the potential to reinforce health inequities. Patients can perceive judgment, presumptuousness, or callousness from the clinician, undermining the clinician−patient relationship. Patients may have unmet expectations when clinicians cannot adequately help address social risk; this can also create an opportunity cost, and time may be better spent addressing other medical concerns. In some cases, there may even be social stigma and legal consequences with identifying social risk. If these harms exist, they need to be understood fully to determine the net benefit of screening and counseling for SDH.
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Clearly, SDH have a significant impact on patient health. There is no question that efforts are needed to address social risks. However, there are numerous evidence gaps across many different SDH that need to be filled before the USPSTF can fully understand the role of primary care in integrating social and clinical care. The method’s principles used by the USPSTF to make recommendations can help to inform research in designing the studies needed to address these gaps. Given the significant influence of SDH and well-being, investing in high-quality research can have a tremendous public health benefit.
Publication of this article was supported by the Agency for Healthcare Research and Quality (AHRQ), under HHS contract [1R13HS026664], Kaiser Permanente [CRN5374-754415320], and the Robert Wood Johnson Foundation [75922]. The findings and conclusions in this article are those of the authors and do not necessarily represent the official position of any of the sponsors. Dr. Krist and Dr. Davidson are members of the USPSTF. This manuscript does not necessarily represent the views and policies of the USPSTF. Dr. Ngo-Metzger and Dr. Justin Mills are members of AHRQ. No financial disclosures were reported by the authors of this paper.
SUPPLEMENT NOTE Population and Context For SDH, it will be critical to understand which populations should receive the preventive service. The prevalence of social risks is highly variable in different patient populations, communities, and practices. This will have a tremendous impact on the likelihood of identifying a condition, the types of conditions that are important for a clinician to consider, and the overall balance of benefit versus harm. There are substantial evidence gaps in understanding which populations experience adverse health outcomes from social risks and which populations will benefit from intervention. Similarly, patient, clinical, community, and service context may be critically important in determining net benefit. Addressing SDH is unique from other clinical preventive services in that addressing a social risk will likely take a referral to or support from a nonhealthcare entity in the community. It is conceivable that what works in one setting may not have the infrastructure to work in others. From the service perspective, some social risks may be much more difficult to address than others. Likewise, from the patient and clinical perspective, some social risks may be possible to address at some stages in a patient’s life but not others. There is a growing body of evidence that social risks such as lower childhood SES and exposure to stressful events early in life can predict adult health outcomes. Whether or not the negative effects of these exposures can be mitigated later in life is unclear.29 Because of the significant influence of population and context on the certainty and net benefit of SDH, it may not be possible to make a generic SDH prevention recommendation. Rather, more personalized and contextualized recommendations may be required based on age, gender, race, ethnicity, comorbid conditions, and setting. December 2019
This article is part of a supplement entitled Identifying and Intervening on Social Needs in Clinical Settings: Evidence and Evidence Gaps, which is sponsored by the Agency for Healthcare Research and Quality of the U.S. Department of Health and Human Services, Kaiser Permanente, and the Robert Wood Johnson Foundation.
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Social Determinants as a Preventive Service: U.S. Preventive Services Task Force Methods Considerations for Research Alex H. Krist, MD, MPH,1 Karina W. Davidson, PhD, MASc,2 Quyen Ngo-Metzger, MD, MPH,3 Justin Mills, MD, MPH3
The body of research on social determinants of health is rapidly accumulating. The U.S. Preventive Services Task Force is conducting evaluations to consider the inclusion of screening and counseling for social risks as a clinical preventive service. Yet, for many social risks, evidence is still likely needed before the U.S. Preventive Services Task Force can recommend universal screening or counseling. This manuscript offers a brief review of the social determinants of health that may be germane to the U.S. Preventive Services Task Force, the methods the U.S. Preventive Services Task Force uses to evaluate relevant evidence, and current evidence gaps for social risks. Key methods for making clinical preventive service recommendations are applied for considering the integration of social and clinical care. These methods include determining the certainty of the evidence, assessing the net benefit, defining appropriate prevention frameworks, defining health outcomes versus intermediate outcomes, fully assessing the harms, and defining to what populations and care contexts the evidence applies. This road map for research is intended to spark ingenuity and purpose in the next generation of research studies, thereby ensuring that future recommendations to address and prevent social risks in primary care are informed by high-quality evidence.
Supplement information: This article is part of a supplement entitled Identifying and Intervening on Social Needs in Clinical Settings: Evidence and Evidence Gaps, which is sponsored by the Agency for Healthcare Research and Quality of the U.S. Department of Health and Human Services, Kaiser Permanente, and the Robert Wood Johnson Foundation. Am J Prev Med 2019;57(6S1):S6−S12. © 2019 American Journal of Preventive Medicine. Published by Elsevier Inc. This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).
INTRODUCTION
T
here is a pressing need to address health disparities caused by adverse social determinants of health (SDH). Calls to integrate social and clinical care have been issued by the National Academies of Medicine, WHO, and many others.1−3 Clearly, gender, race, social class, poverty, and other social variables have significant influences on health and well-being. Effectively addressing adverse SDH could potentially save more lives than further medical advances.4 One possible solution is for primary care clinicians to screen and counsel for social risks.5 The U.S. Preventive Services Task Force (USPSTF) has assembled a workgroup to develop a road map on how the USPSTF might approach and prioritize addressing SDH as S6
a clinical preventive service. The workgroup consists of members from the USPSTF, Evidence-based Practice Centers, the Agency for Healthcare Research and Quality, and additional topic experts. The workgroup is considering the SDH definitions to be employed by the USPSTF, domains and components of SDH currently incorporated into existing recommendations, SDH domains and components From the 1Department of Family Medicine and Population Health, Virginia Commonwealth University, Richmond, Virginia; 2Department of Medicine, Northwell Health, New York, New York; and 3Center for Evidence and Practice Improvement, Agency for Healthcare Research and Quality, Rockville, Maryland Address correspondence to: Alex H. Krist, MD, MPH, 830 East Main St, Room 631, Richmond VA 23219. E-mail: [email protected]. 0749-3797/$36.00 https://doi.org/10.1016/j.amepre.2019.07.013
Am J Prev Med 2019;57(6S1):S6−S12 © 2019 American Journal of Preventive Medicine. Published by Elsevier Inc. This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).
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relevant to clinical preventive services, which SDH may have more evidence available for review and consideration, how to consistently address SDH in evidence reviews and recommendation statements, and novel methods needed to better evaluate SDH evidence. However, there are significant evidence gaps in determining whether clinicians should screen every patient for social needs.6,7 Before integrating social care into clinical care, it is not enough to merely know that having a social risk is detrimental for health. Validated instruments are needed to identify who has a social risk, effective interventions and actions to address social risks,8,9 evidence that finding social risks early and addressing them in health care improves health outcomes, and finally, an understanding of the potential harms for patients and clinicians. High-quality evidence is needed to recommend any clinical preventive service. Prevention recommendations apply to broad segments of the population that are healthy or have unrecognized conditions. A new prevention recommendation becomes an expectation for care. It has workflow implications, can change the very nature of clinician −patient interactions, and demands necessary infrastructure to support routine delivery. Preventive services often become alerts in electronic medical records and quality measures that clinicians strive to improve. These efforts consume time, resources, and attention. The USPSTF is an independent body and has wellestablished methods for assessing the primary evidence to understand the certainty of the evidence and the net benefit of preventive services.10,11 From this assessment, the USPSTF issues guidelines on preventive care that can be delivered in or referred to by primary care. Although others make guideline recommendations as well, they may use different methods (e.g., also include professional opinion), consider different levels of evidence (e.g., include studies with greater risk of bias), or target different audiences (e.g., the Community Preventive Services Task Force considers interventions that can be delivered by communities). Accordingly, though the USPSTF considers other reviews, it commissions its own evidence reviews. This article considers the unique issues with integrating social and clinical care within the context of the USPSTF recommendation framework. This can provide a roadmap to help inform the design and types of studies needed to assess the value of integrating social care into clinical care.
DEFINING SOCIAL DETERMINANTS OF HEALTH 12−15
There are multiple definitions for SDH. For example, Healthy People 2020 defines SDH as “conditions in the environments in which people are born, live, learn, work, play, worship, and age that affect a wide range of health, December 2019
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functioning, and quality-of-life outcomes and risks.” As the USPSTF considers expanding its recommendations to include SDH, the USPSTF reviewed the many differing definitions and domains of SDH proposed by multiple authors, agencies, and societies. The USPSTF then decided to initially consider the domains included in the Centers for Medicare and Medicaid Services’ (CMS) Accountable Health Communities Model.16 Their 5 core SDH domains are housing instability, food insecurity, transportation difficulties, utility assistance needs, and interpersonal safety.17 The CMS is conducting a demonstration in 31 sites nationwide, focusing first on these 5 core domains thought to be intervenable or modifiable. Their final SDH screening tool also includes 8 supplemental domains: financial strain, employment, family and community support, education, physical activity, substance use, mental health, and disabilities. These 13 domains are a comprehensive start for consideration by the USPSTF; there are plans to consider other domains in later stages.
CURRENT U.S. PREVENTIVE SERVICES TASK FORCE RECOMMENDATIONS To date, the USPSTF has reviewed the evidence and made recommendations for the CMS core SDH domain of interpersonal safety—specifically for intimate partner violence and child maltreatment (Table 1).18−20 There are also recommendations for some of the CMS supplemental SDH domains including 9 health behaviors and 3 mental health topics. The fact that the USPSTF has not evaluated whether to screen for other SDH domains is neither a recommendation for nor against screening. The USPSTF has not reviewed the evidence for these topics because some SDH were not considered a clinical preventive service, and some had a paucity of evidence. For example, although the neighborhood of residence and its built environment are both very important SDH, the USPSTF considers these out of scope because primary care interventions would likely have limited effect on where a patient resides. These particular SDH may be considered in scope for the Community Preventive Services Task Force to examine rather than the USPSTF.21 However, the field is rapidly changing, and advances may allow for consideration of more SDH as clinical preventive services.
SOCIAL DETERMINANTS OF HEALTH RESEARCH METHODS CONSIDERATIONS Multiple evidence gaps need to be addressed before recommending clinical preventive services to address SDH. An overview of the general evidence needs is highlighted in Table 2.
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Table 1. USPSTF Recommendations Addressing Social Determinants of Health Title
Year
Recommendation
Screening for IPV, elder abuse, and abuse of vulnerable adults
2018
Primary care interventions to prevent child maltreatment
2018
The USPSTF recommends that clinicians screen women of childbearing age for IPV, such as domestic violence, and provide or refer women who screen positive to intervention services. (Grade: B recommendation) The USPSTF concludes that the current evidence is insufficient to assess the balance of benefits and harms of screening all elderly or vulnerable adults (physically or mentally dysfunctional) for abuse and neglect. (Grade: I statement) The USPSTF concludes that the current evidence is insufficient to assess the balance of benefits and harms of primary care interventions to prevent child maltreatment. (Grade: I statement)
Note: Additional recommendation statements about Modifiable Health Behaviors included in some definitions of social determinants: Screening and Behavioral Counseling Interventions to Reduce Unhealthy Alcohol Use in Adolescents and Adults (B recommendation in 2013); Screening for Drug Use in Adolescents and Adults, Including Pregnant Women (I recommendation in 2008); Primary Care Behavioral Interventions to Reduce Illicit Drug and Nonmedical Pharmaceutical Use in Children and Adolescents (I recommendation in 2014); Behavioral and Pharmacotherapy Interventions for Tobacco Smoking Cessation in Adults, Including Pregnant Women (A recommendation in 2015); Primary Care Interventions to Prevent Tobacco and Nicotine Use in Children and Adolescents (B recommendation in 2013); Behavioral Counseling to Promote a Healthful Diet and Physical Activity for Cardiovascular Disease Prevention in Adults with Cardiovascular Risk Factors (B recommendation in 2014); Behavioral Counseling to Promote a Healthful Diet and Physical Activity for Cardiovascular Disease Prevention in Adults Without Known Risk Factors (C recommendation in 2017); Behavioral and Pharmacotherapy Weight Loss Interventions to Prevent Obesity-Related Morbidity and Mortality in Adults (B recommendation in 2018); Screening for Obesity in Children and Adolescents (B recommendation in 2017). Additional recommendation statements about Mental Health included in some definitions of social determinants: Screening for Depression in Adults (B recommendation in 2016); Screening for Depression in Children and Adolescents (B recommendation in 2016); Interventions to Prevent Perinatal Depression (new topic under review). IPV, intimate partner violence; USPSTF, U.S. Preventive Services Task Force.
Certainty and Net Benefit Every USPSTF recommendation is based on 2 critical assessments: (1) the certainty of the evidence and (2) the net benefit of the preventive service.22 An example analytic framework for a screening preventive service is shown in Figure 1. Evidence is needed either
for the “direct evidence pathway” (often called Key Question 1 [KQ1]) or for each key question in the “indirect evidence pathway.” In the direct evidence pathway, studies randomize a population to either receive screening or not and then measure all potential benefits and harms from the screening and treatment
Table 2. Evidence Needs for Integrating Clinical and Social Care USPSTF methods principle Certainty Net benefit
Prevention framework
Outcomes
Harms Population
Context
Evidence needs Conduct more studies to increase certainty when assessing benefits and harms Field more RCTs, particularly to assess interventions and direct evidence (KQ1) Conduct more direct (KQ1) evidence studies that compare those offered a screening or counseling versus not offered Develop and test interventions to address social risks that are feasible to deliver in or referable to by primary care Test whether the ideal approach is as a screening service or counseling service Test whether screening or counseling is about addressing any or all social risks versus specific social risks Determine if offering screening or counseling to all patients (preventive service) is better than just when there is a need (case finding) Determine if screening or counseling in the clinical setting adds anything to addressing social risks primarily through social services agencies Better understand the mechanisms of how addressing social risks can lead to improved health outcomes Develop accepted health outcomes for social care Develop accepted thresholds for when a health outcome change is significant Evaluate the linkage between potential intermediate outcomes for social risks and health outcomes Evaluate the full range of harms for integrating social and clinical care including anxiety, unintended consequences, labeling, unmet expectations, opportunity costs, stigma, and legal consequences Determine the social risks of different populations Determine which interventions are effective at addressing social risks in different populations Assess the applicability of screening or counseling evidence to a range of patient populations Understand how the patient, community, clinical, and service context influences the certainty and net benefit of screening or counseling
KQ, key question; USPSTF, U.S. Preventive Services Task Force.
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Figure 1. USPSTF analytic framework for a generic screening test. Note: KQ1 represents the direct evidence pathway. KQ1: Is there evidence that randomizing patients to screening or not screening results in improved length or quality of life? The indirect evidence pathway is evaluated by linking the assessments of KQ2 through KQ8. KQ2: Who are the persons at risk for the condition? KQ3: What are the performance characteristics of the screening test? KQ4: Does treatment of the screen-detected condition result in improved intermediate outcomes? KQ5: Does treatment of the screen-detected condition result in reduced morbidity and mortality? KQ6: Does an improvement in intermediate outcomes lead to improved health outcomes? KQ7: What are the harms associated with screening for the condition? KQ8: What are the harms associated with treating the condition? KQ, key question; USPSTF, U.S. Preventive Services Task Force.
process. The indirect evidence pathway involves linking a series of studies that define the population of interest (KQ2), assessing the accuracy (KQ3) and harms (KQ7) of the screening test, evaluating the benefits (KQ4 and KQ5) and harms (KQ8) of treatments once a condition is identified, and determining the effect on health outcomes (KQ5 and KQ6). When assessing certainty, RCTs are the most effective study design for limiting the risk of bias. This is particularly true for KQ1, KQ4, and KQ5 studies. Other key questions often require other types of study designs—sensitivity and specificity designs for understanding screening test characteristics (KQ3) or observational cohort studies for understanding harms (KQ7 and KQ8). Both certainty and net benefit can be assessed directly from KQ1 studies, whereas assessing the indirect evidence pathway involves assessing the evidence quality for each key question and also the ability to link the evidence across the key questions.22 There are few, if any, KQ1 studies that randomize patients to be screened or not to be screened for a social risk. Even the USPSTFrecommended service, screening for intimate partner violence, lacks KQ1 evidence and relies on the indirect evidence pathway.23 When thinking about the current state of evidence about SDH, there is often clear evidence that having the social risk leads to poor health, and frequently there are validated screening instruments that can identify need for interventions.17,24,25 Commonly missing is evidence for effective interventions that are feasible to deliver in or referable to from primary care.25
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Prevention Framework Research is needed to define the nature of an SDH clinical preventive service. Many presuppose that the most appropriate way to provide the SDH service is as a screening service—ask patients about whether they have a social risk and counsel or support those who screen positive (Figure 1). Alternatively, an SDH service could be considered more when using the USPSTF counseling framework. For this approach, all appropriate patients would receive counseling to prevent or ameliorate the social risk (Figure 2). Using food insecurity as a hypothetical example, the screening framework would involve asking patients if they are experiencing food insecurity and then providing an intervention to those who respond positively. Whereas conceived as a counseling service, all individuals in an atrisk group (e.g., all families with younger children or all individuals on Medicaid) might receive information and support to improve access to healthy food options, irrespective of whether a risk is identified. Each approach has unique advantages and disadvantages that would need to be considered when designing and evaluating the preventive service. Complicating matters is whether the preventive service is about addressing any or all social risks versus addressing a specific social risk. To date, the USPSTF has conceptualized SDH as a screening service for a specific social risk (i.e., intimate partner violence or child maltreatment). Alternatively, some have hypothesized that there may be a single question or set of questions that could indicate the presence of any or all social risks. Patients who have
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Figure 2. USPSTF analytic framework for a generic counseling service. Notes: KQ1 represents the direct evidence pathway. KQ1: Is there direct evidence that behavioral or counseling interventions reduce disease morbidity or mortality? The indirect evidence pathway is evaluated by linking the assessments of KQ2 through KQ5. KQ2: What is the target group? KQ3: Does the behavioral or counseling intervention result in a change in intermediate behavioral or other outcomes? KQ4: Does the intermediate outcome or behavior change lead to reduced morbidity or mortality? KQ5: What are the harms associated with the behavioral counseling intervention for the condition? KQ, key question; USPSTF, U.S. Preventive Services Task Force.
1 social risk are likely to have multiple social risks. Screening and interventions may have to address a range or bundle of potential risks to be effective. Understanding the right approach will be critical for the field. Additionally, evidence is needed to demonstrate whether providing an SDH preventive services is better than case finding. With case finding, clinicians might only assess for a social risk when they have a concern, when risks are identified as part of a history or exam, or when patients mention needs. Case finding may be more effective than systematically screening all patients. For example, providing free transportation vouchers to patients only when the clinician identifies or the patient brings up a need may be more efficient than providing all patients with a voucher, regardless of need, or even screening all patients for transportation needs. Conversely, patients may be hesitant to bring up social risks or may not think that their clinician can help them. Screening or counseling may be necessary to identify and help those at risk and reduce the stigma with selectively addressing SDH. It is also unclear the degree to which SDH should be identified and addressed in primary care, or whether risks should primarily be addressed by public health and social service agencies. These organizations often have addressing social needs as their primary focus, and they may have skills and resources not available or referable to by primary care. Integrating the delivery of social and clinical care may create inefficiencies and divert limited resources from those who can better help patients. For example, if addressing social care is set up as part of a healthcare business, generating profits could take away from providing social services. Conversely, the clinical setting may bring new resources that can be used to address risks, help to identify those at risk, better direct those with risks to the right care, and positively reinforce assistance. A multifaceted approach with linkages between primary care and community resources could increase the effectiveness of interventions and improve outcomes for patients.
Outcomes Before recommending any preventive service, the USPSTF requires evidence that the service improves health outcomes and not just intermediate outcomes. The USPSTF defines a health outcome as improved quality or length of life, and it defines intermediate outcomes as pathologic, physiologic, psychological, social, or behavioral measures.26 Intermediate outcomes are differentiated from health outcomes in that health outcomes are experienced by the patient. For intimate partner violence, screening and subsequent interventions have been shown to reduce physical and mental harms, both of which are considered health outcomes, hence the USPSTF found that the evidence was adequate to recommend screening. Evidence is needed that clearly links whether addressing SDH improves health outcomes. This could occur through several pathways. First, screening and counseling for a social risk may help patients better manage their chronic conditions and thus prevent hospitalizations, complications, and even death. For example, financial strain might lead to limited adherence to treatment plans and preventive cardiovascular medications because of out-ofpocket costs. Interventions to decrease cost might ensure that a patient can take the medication that has been shown to prevent premature morbidity and death. Second, screening and counseling might also improve clinician or patient decisions, understanding, and communication.27 For example, identifying a patient with lower health literacy could be used to tailor the type of decision aid or educational material that might be used with a patient to make an important health decision, like screening for prostate cancer or deciding on the most appropriate surgical approach for early stage breast cancer. Third, knowing the social risks a patient is experiencing may help clinicians better tailor treatment. When helping to develop a weight loss program for a patient with obesity and prediabetes, knowing financial, transportation, or time constraints can change what a clinician recommends for a patient.
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Krist et al / Am J Prev Med 2019;57(6S1):S6−S12 Fourth, addressing the social risk itself could result in improved quality of life, which the USPSTF considers a primary health outcome. Interventions to prevent child maltreatment or counseling to prevent perinatal depression exemplify such a direct path to improved health.20,28 For SDH, needed information includes (1) a better understanding about which outcomes are health outcomes and which are intermediate outcomes, (2) evidence that clearly links intermediate outcomes to health outcomes, (3) an understanding about the thresholds of change that are clinically meaningful, and (4) study designs that can address the impacts on health outcomes.
Future Directions
Harms
ACKNOWLEDGMENTS
In addition to understanding beneficial outcomes, evidence is needed to truly understand the harms of screening and counseling for social risks.6 Identifying a social risk during the clinical encounter can increase stress, anxiety, and unhappiness because patients and clinicians struggle to address a social risk that may be difficult to change. Labeling has the potential to reinforce health inequities. Patients can perceive judgment, presumptuousness, or callousness from the clinician, undermining the clinician−patient relationship. Patients may have unmet expectations when clinicians cannot adequately help address social risk; this can also create an opportunity cost, and time may be better spent addressing other medical concerns. In some cases, there may even be social stigma and legal consequences with identifying social risk. If these harms exist, they need to be understood fully to determine the net benefit of screening and counseling for SDH.
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Clearly, SDH have a significant impact on patient health. There is no question that efforts are needed to address social risks. However, there are numerous evidence gaps across many different SDH that need to be filled before the USPSTF can fully understand the role of primary care in integrating social and clinical care. The method’s principles used by the USPSTF to make recommendations can help to inform research in designing the studies needed to address these gaps. Given the significant influence of SDH and well-being, investing in high-quality research can have a tremendous public health benefit.
Publication of this article was supported by the Agency for Healthcare Research and Quality (AHRQ), under HHS contract [1R13HS026664], Kaiser Permanente [CRN5374-754415320], and the Robert Wood Johnson Foundation [75922]. The findings and conclusions in this article are those of the authors and do not necessarily represent the official position of any of the sponsors. Dr. Krist and Dr. Davidson are members of the USPSTF. This manuscript does not necessarily represent the views and policies of the USPSTF. Dr. Ngo-Metzger and Dr. Justin Mills are members of AHRQ. No financial disclosures were reported by the authors of this paper.
SUPPLEMENT NOTE Population and Context For SDH, it will be critical to understand which populations should receive the preventive service. The prevalence of social risks is highly variable in different patient populations, communities, and practices. This will have a tremendous impact on the likelihood of identifying a condition, the types of conditions that are important for a clinician to consider, and the overall balance of benefit versus harm. There are substantial evidence gaps in understanding which populations experience adverse health outcomes from social risks and which populations will benefit from intervention. Similarly, patient, clinical, community, and service context may be critically important in determining net benefit. Addressing SDH is unique from other clinical preventive services in that addressing a social risk will likely take a referral to or support from a nonhealthcare entity in the community. It is conceivable that what works in one setting may not have the infrastructure to work in others. From the service perspective, some social risks may be much more difficult to address than others. Likewise, from the patient and clinical perspective, some social risks may be possible to address at some stages in a patient’s life but not others. There is a growing body of evidence that social risks such as lower childhood SES and exposure to stressful events early in life can predict adult health outcomes. Whether or not the negative effects of these exposures can be mitigated later in life is unclear.29 Because of the significant influence of population and context on the certainty and net benefit of SDH, it may not be possible to make a generic SDH prevention recommendation. Rather, more personalized and contextualized recommendations may be required based on age, gender, race, ethnicity, comorbid conditions, and setting. December 2019
This article is part of a supplement entitled Identifying and Intervening on Social Needs in Clinical Settings: Evidence and Evidence Gaps, which is sponsored by the Agency for Healthcare Research and Quality of the U.S. Department of Health and Human Services, Kaiser Permanente, and the Robert Wood Johnson Foundation.
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