Linking food insecurity and smoking cessation: In response to "Food insecurity transitions and smoking behavior among older adults who smoke".

This Letter to the Editor raises questions regarding a recently published article, "Food insecurity transitions and smoking behavior among older adults who smoke."

Aspects of Depression Among Socioeconomically Disadvantaged African American Young Adults.

The purpose of this phronetic/pragmatic, mixed-methods study was to integrate quantitative data with qualitative data in examining the complex relations among depression, exercise, screen-viewing time, and life plans among 14 socioeconomically disadvantaged African American young adults. Based on the thematic analysis, the two emerging themes were as follows: life priorities (passing the General Educational Development [GED] test, pursuing profession/career, and being dedicated to church/ministry) and challenges in passing GED examination (e.g., difficulties with the GED test, high stress and low confidence, low interest in studying, health issues, and feelings of rejection/isolation). Based on cross tabulation, depression was highly associated with aerobic exercise and screen-viewing time (Cramer's V = .44 and .42, respectively). Participants' life challenges diminished the antidepressant effect of exercise and were linked to depression and excessive screen use. Two active men and a somewhat active woman experienced educational or health-related struggles, heavy screen watching, and severe depression. All three active men experienced educational challenges and severe depression. Two inactive participants reported limited screen use and limited depression, possibly because of their valued life goals (e.g., writing poetry and spiritually helping others). Contrary to the dominant cultural stereotype about African Americans being lazy, the study results show that the participants had highly similar career goals to the majority population yet faced many, significant structural barriers that interfered with their progress and thus sapped their motivation in achieving their life plans. Policy change is needed to reduce social structural barriers and racial systems of oppression in order to decrease poverty and depression.

Detecting Dysglycemia Using the 2015 United States Preventive Services Task Force Screening Criteria: A Cohort Analysis of Community Health Center Patients.

BACKGROUND: In 2015, the United States Preventive Services Task Force (USPSTF) recommended targeted screening for prediabetes and diabetes (dysglycemia) in adults who are aged 40 to 70 y old and overweight or obese. Given increasing prevalence of dysglycemia at younger ages and lower body weight, particularly among racial/ethnic minorities, we sought to determine whether the current screening criteria may fail to identify some high-risk population subgroups. METHODS AND FINDINGS: We investigated the performance of the 2015 USPSTF screening recommendation in detecting dysglycemia among US community health center patients. A retrospective analysis of electronic health record (EHR) data from 50,515 adult primary care patients was conducted. Longitudinal EHR data were collected in six health centers in the Midwest and Southwest. Patients with a first office visit between 2008 and 2010 were identified and followed for up to 3 y through 2013. We excluded patients who had dysglycemia at baseline and those with fewer than two office visits during the follow-up period. The exposure of interest was eligibility for screening according to the 2015 USPSTF criteria. The primary outcome was development of dysglycemia during follow-up, determined by: (1) laboratory results (fasting/2-h postload/random glucose ≥ 100/140/200 mg/dL [5.55/7.77/11.10 mmol/L] or hemoglobin A1C ≥ 5.7% [39 mmol/mol]); (2) diagnosis codes for prediabetes or type 2 diabetes; or (3) antidiabetic medication order. At baseline, 18,846 (37.3%) participants were aged ≥40 y, 33,537 (66.4%) were overweight or obese, and 39,061 (77.3%) were racial/ethnic minorities (34.6% Black, 33.9% Hispanic/Latino, and 8.7% Other). Overall, 29,946 (59.3%) patients had a glycemic test within 3 y of follow-up, and 8,478 of them developed dysglycemia. Only 12,679 (25.1%) patients were eligible for screening according to the 2015 USPSTF criteria, which demonstrated the following sensitivity and specificity (95% CI): 45.0% (43.9%-46.1%) and 71.9% (71.3%-72.5%), respectively. Racial/ethnic minorities were significantly less likely to be eligible for screening yet had higher odds of developing dysglycemia than whites (odds ratio [95% CI]: Blacks 1.24 [1.09-1.40]; Hispanics 1.46 [1.30-1.64]; and Other 1.33 [1.16-1.54]). In addition, the screening criteria had lower sensitivity in all racial/ethnic minority groups compared to whites. Limitations of this study include the ascertainment of dysglycemia only among patients with available test results and findings that may not be generalizable at the population level. CONCLUSIONS: Targeted diabetes screening based on new USPSTF criteria may detect approximately half of adult community health center patients with undiagnosed dysglycemia and proportionately fewer racial/ethnic minorities than whites. Future research is needed to estimate the performance of these screening criteria in population-based samples.

Diagnostic colonoscopy following a positive fecal occult blood test in community health center patients.

PURPOSE: Fecal occult blood testing (FOBT) is a pragmatic screening option for many community health centers (CHCs), but FOBT screening programs will not reduce mortality if patients with positive results do not undergo diagnostic colonoscopy (DC). This study was conducted to investigate DC completion among CHC patients. METHODS: This retrospective cohort study used data from three CHCs in the Midwest and Southwest. The primary study outcome was DC completion within 6 months of positive FOBT among adults age 50-75. Patient data was collected using automated electronic queries. Manual chart reviews were conducted if queries produced no evidence of DC. Poisson regression models described adjusted relative risks (RRs) of DC completion. RESULTS: The study included 308 patients; 63.3 % were female, 48.7 % were Spanish speakers and 35.7 % were uninsured. Based on combined query and chart review findings, 51.5 % completed DC. Spanish speakers were more likely than English speakers to complete DC [RR 1.19; 95 % confidence interval (CI) 1.04-1.36; P = 0.009], and DC completion was lower among patients with 0 visits than those with 1-2 visits (RR 2.81; 95% CI 1.83-4.33; P < 0.001) or ≥3 visits (RR 3.06; 95% CI 1.57-5.95; P = 0.001). CONCLUSIONS: DC completion was low overall, which raises concerns about whether FOBT can reduce CRC mortality in practice. Further research is needed to understand whether CHC navigator programs can achieve very high DC rates. If organizations use FOBT as their primary CRC screening approach and a substantial number of patients receive positive results, both screening rates and DC rates should be measured.

Two-year follow-up of the effectiveness of a multifaceted intervention to improve adherence to annual colorectal cancer screening in community health centers.

PURPOSE: We previously found that a multifaceted outreach intervention achieved 82 % annual adherence to colorectal cancer (CRC) screening with fecal occult blood testing (FOBT). This study assessed adherence to FOBT after a second outreach. METHODS: We followed 225 patients in community health centers in Chicago, Illinois, who were randomized to the intervention group. Our primary analysis focused on 124 patients who completed FOBT during the first outreach and were due again for annual FOBT; 90% were Latino, 87% preferred to speak Spanish, and 77% were uninsured. Second outreach consisted of (1) a mailed reminder letter, a free fecal immunochemical test (FIT) with postage-paid return envelope, (2) automated phone and text messages, (3) automated reminders 2 weeks later if the FIT was not returned, and (4) a telephone call after 3 months. Our main outcome was completion of FIT within 6 months of the due date. We also analyzed the proportion of the original 225 patients who were fully screened for CRC over the 2-year study period. RESULTS: A total of 88.7% of patients completed a FIT within 6 months of their second outreach. Over the 2 years since the first outreach, 71.6% of the 225 patients assigned to the intervention group were fully up to date on CRC screening, another 11.1% had been screened suboptimally, and 17.3% were inadequately screened or not screened. CONCLUSIONS: It is possible to achieve high rates of CRC screening over a 2-year period for vulnerable populations using outreach with FIT as a primary strategy.

Comparative Effectiveness of Multifaceted Outreach to Initiate Colorectal Cancer Screening in Community Health Centers: A Randomized Controlled Trial.

INTRODUCTION: Colorectal cancer (CRC) screening rates are low among vulnerable populations. Fecal immunochemical tests (FITs) are one screening modality with few barriers. Studies have shown that outreach can improve CRC screening, but little is known about its effectiveness among individuals with no CRC screening history. We sought to determine whether outreach increases FIT uptake among patients with no CRC screening history compared to usual care. METHODS: This study was a patient-level randomized controlled trial, including 420 patients who had never completed CRC screening and were eligible for FIT; 66% were female, 62.1% were Latino, and 70.7% were uninsured. The main outcome measure was FIT completion within 6 months of the randomization date. We assessed FIT completion at different time points corresponding to receipt of outreach components. All analyses were re-run with 12-month data. RESULTS: Patients who received outreach were more likely to complete FIT than those in usual care (36.7% vs. 14.8%; p < 0.001). FIT completion was more common among patients with increased clinic visits. The difference in FIT completion between the outreach and usual care groups decreased over time. DISCUSSION: The intervention improved FIT uptake among patients with no CRC screening history. However, the intervention was less effective than in a previous trial targeting patients due for repeat screening. Additional research is needed to determine the best methods for improving CRC screening among this hard-to-reach group.

Promoting Justice and Autonomy in Public Policies to Reduce the Health Consequences of Obesity.

Public policies to reduce the extent of obesity in the United States have generated considerable public controversy. The paper examines the implications of proposed policies for the principles of justice and autonomy and key assumptions underlying the major contending positions with respect to the relative weight that should be assigned to them in balancing their respective claims. The analysis traces the crux of the debate regarding the ethical warrant for policies to restrict access to calorie-dense foodstuffs to two key issues: the appeal to different and conflicting theories of justice, and the conflation of autonomy with negative liberty in public debates. After clarifying the ethically relevant characteristics of autonomy that merit defense, the paper concludes with a description of how the capabilities approach to justice may offer a more coherent ethical framework for developing and evaluating policies to address the current obesity epidemic.

Tensions between the conduct of randomised controlled trials in health promotion research and the role of autonomy in human health and well being.

The goal of developing increasingly effective interventions to change health-related behaviours, which is an inevitable result of the use of the scientific method, conflicts with respect for the autonomy and dignity of the individual. This paper recommends a new direction for the field of health promotion based on building people's capacity to exercise autonomy, in the ethically relevant meaning of the term, and thereby promote a more comprehensive understanding of the goals of the field, a state of health that includes the irreducible ethical dimension signified by human dignity.

Design of a randomized controlled trial to assess the comparative effectiveness of a multifaceted intervention to improve adherence to colorectal cancer screening among patients cared for in a community health center.

BACKGROUND: Colorectal cancer (CRC) is common and leads to significant morbidity and mortality. Although screening with fecal occult blood testing (FOBT) or endoscopy has been shown to decrease CRC mortality, screening rates remain suboptimal. Screening rates are particularly low for people with low incomes and members of underrepresented minority groups. FOBT should be done annually to detect CRC early and to reduce CRC mortality, but this often does not occur. This paper describes the design of a multifaceted intervention to increase long-term adherence to FOBT among poor, predominantly Latino patients, and the design of a randomized controlled trial (RCT) to test the efficacy of this intervention compared to usual care. METHODS: In this RCT, patients who are due for repeat FOBT are identified in the electronic health record (EHR) and randomized to receive either usual care or a multifaceted intervention. The usual care group includes multiple point-of-care interventions (e.g., standing orders, EHR reminders), performance measurement, and financial incentives to improve CRC screening rates. The intervention augments usual care through mailed CRC screening test kits, low literacy patient education materials, automated phone and text message reminders, in-person follow up calls from a CRC Screening Coordinator, and communication of results to patients along with a reminder card highlighting when the patient is next due for screening. The primary outcome is completion of FOBT within 6 months of becoming due. DISCUSSION: The main goal of the study is to determine the comparative effectiveness of the intervention compared to usual care. Additionally, we want to assess whether or not it is possible to achieve high rates of adherence to CRC screening with annual FOBT, which is necessary for reducing CRC mortality. The intervention relies on technology that is increasingly widespread and declining in cost, including EHR systems, automated phone and text messaging, and FOBTs for CRC screening. We took this approach to ensure generalizability and allow us to rapidly disseminate the intervention through networks of community health centers (CHCs) if the RCT shows the intervention to be superior to usual care. TRIAL REGISTRATION: ClinicalTrials.gov NCT01453894.

Adherence to repeat fecal occult blood testing in an urban community health center network.

Annual fecal occult blood testing (FOBT) has the potential to reduce colorectal cancer mortality, but in practice it is challenging to complete FOBT every year. Repeat FOBT adherence may be especially low in community health center (CHC) settings, where many patients face barriers to annual FOBT completion. We conducted a retrospective cohort analysis to investigate adherence to annual FOBT in an urban CHC network that serves a predominantly Spanish-speaking, uninsured adult patient population. This study used data from the two-year period between January 2010 and December 2011, and included adults aged 50-74 who completed a screening FOBT with a negative result during the first 6 months of 2010. We examined whether each patient completed a second FOBT between 9 and 18 months after the initial negative FOBT, and tested whether repeat FOBT adherence was associated with patient characteristics or the number of clinic visits after the initial negative FOBT. Only 69 of 281 included patients completed repeat FOBT (24.6 % adherence), and none of 62 patients (0 %) with 0 clinic visits completed repeat FOBT. We detected no significant differences in adherence by age, sex, preferred language, insurance status, or number of chronic conditions. In multivariable regression, the adjusted relative risk of repeat FOBT was 1.66 (95 % CI 1.09-2.54; p = 0.02) among patients with 3 or more clinic visits (referent: patients with 1-2 visits). The observed low rate of adherence greatly diminishes the effectiveness of FOBT in reducing CRC mortality. Findings demonstrate the need for systems-based interventions that increase adherence without requiring face-to-face encounters.

Primary care detection of cognitive impairment leveraging health and consumer technologies in underserved US communities: protocol for a pragmatic randomised controlled trial of the MyCog paradigm.

INTRODUCTION: Early identification of cognitive impairment (CI), including Alzheimer's disease and related dementias (ADRD), is a top public health priority. Yet, CI/ADRD is often undetected and underdiagnosed within primary care settings, and in health disparate populations. The MyCog paradigm is an iPad-based, self-administered, validated cognitive assessment based on the National Institutes of Health (NIH) Toolbox Cognition Battery and coupled with clinician decision-support tools that is specifically tailored for CI/ADRD detection within diverse, primary care settings. METHODS AND ANALYSIS: We will conduct a two-arm, primary care practice-randomised (N=24 practices; 45 257 active patients at the proposed practices), pragmatic trial among geographically diverse Oak Street Health sites to test the effectiveness of the MyCog paradigm to improve early detection CI/ADRD among low socioeconomic, black and Hispanic older adults compared with usual care. Participating practices randomised to the intervention arm will impart the MyCog paradigm as a new standard of care over a 3-year implementation period; as the cognitive component for Annual Wellness Visits and for any patient/informant-reported or healthcare provider-suspected cognitive concern. Rates of detected (cognitive test suggesting impairment) and/or diagnosed (relevant International Classification of Diseases-9/10 [ICD-9/10] code) cognitive deficits, impairments or dementias including ADRD will be our primary outcome of study compared between arms. Secondary outcomes will include ADRD severity (ie, mild or later stage), rates of cognitive-related referrals and rates of family member or caregiver involvement in ADRD care planning. We will use generalised linear mixed models to account for clustered study design. Secondary models will adjust for subject, clinic or visit-specific characteristics. We will use mixed-methods approaches to examine fidelity and cost-effectiveness of the MyCog paradigm. ETHICS AND DISSEMINATION: The Institutional Review Board at Advarra has approved the study protocol (Pro00064339). Results will be published in peer-reviewed journals and summaries will be provided to the funders of the study. TRIAL REGISTRATION NUMBER: NCT05607732.

Identifying important breast cancer control strategies in Asia, Latin America and the Middle East/North Africa.

BACKGROUND: Breast cancer is the most frequent cause of cancer death in women worldwide, but global disparities in breast cancer control persist, due to a lack of a comprehensive breast cancer control strategy in many countries. OBJECTIVES: To identify and compare the need for breast cancer control strategies in Asia, Latin America and the Middle East/North Africa and to develop a common framework to guide the development of national breast cancer control strategies. METHODS: Data were derived from open-ended, semi-structured interviews conducted in 2007 with 221 clinicians, policy makers, and patient advocates; stratified across Asia (n = 97), Latin America (n = 46), the Middle East/North Africa (ME/NA) (n = 39) and Australia and Canada (n = 39). Respondents were identified using purposive and snowballing sampling. Interpretation of the data utilized interpretive phenomenological analysis where transcripts and field notes were coded and analyzed and common themes were identified. Analysis of regional variation was conducted based on the frequency of discussion and the writing of the manuscript followed the RATS guidelines. RESULTS: Analysis revealed four major themes that form the foundation for developing national breast cancer control strategies: 1) building capacity; 2) developing evidence; 3) removing barriers; and 4) promoting advocacy - each specified across five sub-ordinate dimensions. The propensity to discuss most dimensions was similar across regions, but managing advocacy was discussed more frequently (p = 0.004) and organized advocacy was discussed less frequently (p < 0.001) in Australia and Canada. CONCLUSIONS: This unique research identified common themes for the development of breast cancer control strategies, grounded in the experience of local practitioners, policy makers and advocacy leaders across diverse regions. Future research should be aimed at gathering a wider array of experiences, including those of patients.

Should people with unhealthy lifestyles pay higher health insurance premiums?

This commentary sets the article by Dubois on the ethical justification for charging higher insurance premiums for people with unhealthy lifestyles in the context of US health care reform. It reviews the relevance and strength of normative concerns identified by Dubois about the acceptability of such differentiated "means-tested" plans. It identifies key issues involving whether certain health behaviors matter ethically, and if so, the grounds that would justify an obligation for people to take action. The article frames the answer in terms of the need to achieve an ethically acceptable balance between the principle of equality and principle of merit and concludes with four ethical standards to focus the terms of the debate.

Changes in Food Insecurity and Smoking Status over Time: Analysis of the 2003 and 2015 Panel Study of Income Dynamics.

PURPOSE: To examine whether food insecurity longitudinally affects smoking status. DESIGN: Population-based prospective study. SETTING: Data from the 2003 and 2015 Panel Study of Income Dynamics (PSID). PARTICIPANTS: Four thousand five hundred sixty-three adults who were smokers and nonsmokers, participating in the 2003 (current study baseline) and 2015 (current study follow-up) waves of PSID. MEASURES: Based on self-reported smoking status at baseline and follow-up, respondents were categorized as continued smoking, stopped smoking, started smoking, and continued nonsmoking. Similarly, respondents were categorized as stayed food secure, stayed food insecure, became food insecure, and became food secure based on responses to the Food Security Survey at baseline and follow-up. ANALYSIS: Two logistic regression analyses to examine (1) among smokers at baseline the odds of stopping versus continuing smoking by follow-up and (2) among nonsmokers at baseline the odds of starting versus continuing nonsmoking by follow-up. In both models, change in food insecurity status was the primary independent variable, controlling for demographics including poverty. RESULTS: Among smokers at baseline, becoming food insecure (vs staying food secure) was independently associated with lower likelihood of stopping smoking by follow-up (odds ratio [OR] = 0.66). Among nonsmokers at baseline, becoming food insecure (vs staying food secure) was independently associated with higher likelihood of starting smoking by follow-up (OR = 3.77). CONCLUSIONS: Food insecurity is a risk factor for smoking, which has significant implications for developing interventions to reduce smoking prevalence, especially among low-income groups.

Autonomy, paternalism, and justice: ethical priorities in public health.

With attention to the field of public health ethics growing, significant time has been devoted to identifying a sound ethical justification for paternalistic interventions that override individual autonomy to prevent people from adopting unhealthy behaviors. Efforts focused on specifying the conditions that warrant paternalism, however, are largely misplaced. On empirical and ethical grounds, public health should seek instead to expand individual autonomy to improve population health. To promote autonomy, the field should redirect current efforts toward clarifying principles of justice. Although public health's most highly visible stance is associated with an egalitarian conception of "social justice," it is imperative that public health professionals address gaping divisions in public understandings of justice. I present recommendations for initiating this process.

"The Doctor Needs to Know": Acceptability of Smartphone Location Tracking for Care Coordination.

BACKGROUND: Care coordination can be highly challenging to carry out. When care is fragmented across health systems and providers, there is an increased likelihood of hospital readmissions and wasteful health care spending. During and after care transitions, smartphones have the potential to bolster information transfer and care coordination. However, little research has examined patients' perceptions of using smartphones to coordinate care. OBJECTIVE: This study's primary objective was to explore patient acceptability of a smartphone app that could facilitate care coordination in a safety net setting. Our secondary objective was to identify how clinicians and other members of primary care teams could use this app to coordinate care. METHODS: This qualitative study was conducted at a federally qualified health center in metropolitan Chicago, IL. We conducted four focus groups (two in English, two in Spanish) with high-risk adults who owned a smartphone and received services from an organizational care management program. We also conducted structured interviews with clinicians and a group interview with care managers. Focus groups elicited patients' perceptions of a smartphone app designed to: (1) identify emergency department (ED) visits and inpatient stays using real-time location data; (2) send automated notifications (ie, alerts) to users' phones, asking whether they were a patient in the hospital; and (3) send automated messages to primary care teams to notify them about patients' confirmed ED visits and inpatient stays. Focus group transcripts were coded based on emergent themes. Clinicians and care managers were asked about messages they would like to receive from the app. RESULTS: Five main themes emerged in patient focus group discussions. First, participants expressed a high degree of willingness to use the proposed app during inpatient stays. Second, participants expressed varying degrees of willingness to use the app during ED visits, particularly for low acuity ED visits. Third, participants stated their willingness to have their location tracked by the proposed app due to its perceived benefits. Fourth, the most frequently mentioned barriers to acceptability were inconveniences such as "false alarm" notifications and smartphone battery drainage. Finally, there was some tension between how to maximize usability without unnecessarily increasing user burden. Both clinicians and care managers expressed interest in receiving messages from the app at the time of hospital arrival and at discharge. Clinicians were particularly interested in conducting outreach during ED visits and inpatient stays, while care managers expressed more interest in coordinating postdischarge care. CONCLUSIONS: High-risk primary care patients in a safety net setting reported a willingness to utilize smartphone location tracking technology to facilitate care coordination. Further research is needed on the development and implementation of new smartphone-based approaches to care coordination.

Quality-of-life assessment in the symptom management trials of the National Cancer Institute-supported Community Clinical Oncology Program.

PURPOSE: To examine how quality of life (QOL) is prospectively conceptualized, defined, and measured in the symptom management clinical trials supported by the National Cancer Institute Community Clinical Oncology Program (CCOP). METHODS: All QOL research objectives, rationales, assessment instruments, symptoms treated, and types of interventions from the CCOP symptom management portfolio of clinical trials were extracted and analyzed. RESULTS: QOL assessments were proposed in 68 (52%) of the 130 total CCOP symptom management trials initiated since 1987. A total of 22 global QOL instruments were identified. Both the frequency of symptom management trials and the frequency of QOL assessment have increased significantly over time. The Functional Assessment of Cancer Therapy and Uniscale instruments were the most widely used QOL instruments, included in 55% of trials assessing QOL. The conceptual framework for QOL inclusion was limited to univariate relationships between symptom relief and global improvements in QOL. No consistent associations were found between QOL assessment and either the symptoms targeted or types of interventions. CONCLUSION: To advance the state of the science, research protocols need to provide more explicit rationales for assessing QOL in symptom management trials and for the selection of the QOL instrument(s) to be used. Conceptual frameworks that specify the hypothesized links between the specific symptom(s) being managed, interactions with other symptoms, different domains of QOL, and global QOL also need to be more precisely described. Methodologic and conceptual advances in QOL symptom management trials are critical to fulfill the promise of alleviating suffering and improving the QOL of cancer patients.

Research-design issues in cancer-symptom-management trials using complementary and alternative medicine: lessons from the National Cancer Institute Community Clinical Oncology Program experience.

PURPOSE: To identify major research-design issues in proposals submitted by investigators in the Community Clinical Oncology Program (CCOP) for clinical trials of complementary and alternative medicine (CAM) for cancer-symptom management. METHODS: We conducted content analysis of all scientific reviews of concepts and protocols submitted by the CCOP to the National Cancer Institute (NCI) to identify research challenges in conducting clinical trials designed to evaluate CAM interventions for cancer-symptom management. RESULTS: Since the inception of the NCI Office of Cancer Complementary and Alternative Medicine in 1998, a total of 46 symptom-management studies using CAM interventions have been proposed by CCOP investigators, with 20 studies now in progress comprising 22% of the current total CCOP symptom-management portfolio. Proposals fell into four categories: complex natural products; nutritional therapeutics; mind-body interventions; and alternative medical systems. The most significant research-design issues arose as a consequence of the lack of preclinical data for CAM interventions and the lack of quality-control standards comparable with those used in regulating new pharmaceutical agents. CONCLUSION: Across the different types of CAM interventions, the most common problems found in proposed research designs are related to unwarranted assumptions about the consistency and standardization of CAM interventions, the need for data-based justifications for the study hypotheses, and the need to implement appropriate quality control and monitoring procedures during the course of the trial. To advance the state of the science, future research must address these critical issues if CAM interventions are to be evaluated rigorously and have a consequent impact on clinical practice and general public awareness.

Policy needs regarding the duty to protect in epidemiological research with high-risk populations.

The paper presents an analysis of policy directives needed to respond to threats of harm (e.g., violence against third parties) that may arise in the course of conducting descriptive epidemiological research with high-risk populations. It identifies two key areas where new policies must be developed to guide researchers conducting such investigations. The paper recommends that: (1) an NIH consensus panel be convened to set standards, analogous to Common Toxicity Criteria (CTC) criteria, to classify the severity of different types of indirect, non-research-related risk; and (2) case-based training modules be developed and incorporated into public health research ethics courses and training programs, to enhance researcher judgments in determining the likelihood of harm in different situations. In addition, researchers, Institutional Review Boards (IRBs) and community advisory groups must consider the issue of staff safety and the effectiveness of available responses to reduce the threat of harm. The author reviews and discusses implications for informed consent and IRB review.

Perspective: a new ethic for health promotion: reflections on a philosophy of health education for the 21st century.

This article describes two models for thinking about the purposes of health education-a medical model and an education model--and traces how concerns about the validity of research have driven preference for the medical model. In the medical model, the purpose of health education is to develop effective interventions that will prevent people from adopting unhealthy behaviors. Here, health educators are expected to replicate the methods identified by researchers to effect targeted changes in health behavior. The article then describes an alternative way of thinking about the purposes of health education. In pursuing a philosophy of education, the purpose of research and practice would be to clarify basic social values and to strengthen one's faculty for making value judgments. Practitioners here use research results as a stimulus for dialogue about the role of good health habits in living the kind of life that community members find most valuable.