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."

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.

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.

Outreach for Annual Colorectal Cancer Screening: A Budget Impact Analysis for Community Health Centers.

INTRODUCTION: Fecal immunochemical testing (FIT) is an attractive approach for colorectal cancer screening at community health centers. This budget impact analysis investigated benefits and costs of FIT outreach-with FIT kits mailed to patients, followed by reminders and phone calls-compared with point-of-care (POC) strategies. METHODS: Five screening and cost outcomes were simulated over 1 year at a "base case" community health center serving 1000 screening-eligible patients: (1) FIT completion among patients due for screening; (2) proportion up-to-date on screening; (3) cost per patient due for screening; (4) cost per completed FIT; and (5) total organizational cost. Uncertainty analysis investigated potential savings from optimizing staff workflows during FIT outreach. Data were collected in 2012-2014, with analysis conducted 2014-2015. RESULTS: Using POC strategies, 24.0% of patients due for screening completed FIT, versus 42.4% under outreach (18.4% absolute difference). When calculations included patients up-to-date on screening from prior colonoscopy, 41.7% were up-to-date via POC, versus 55.8% for outreach (14.1% absolute difference). POC cost $4.93 per patient, versus $30.43 for outreach ($25.50 difference). Cost per patient screened was $20.60 for POC and $71.84 for outreach ($51.24 difference). Total organizational cost was $3,779 for POC distribution and $23,315 for outreach ($19,536 difference). Outreach costs decreased by approximately one fourth under optimized workflows. CONCLUSIONS: Outreach is an effective, practical, relatively low-cost strategy; costs could be reduced further by optimizing staff workflows. Despite its value, outreach costs more than POC distribution and may be difficult for community health centers to implement under current payment models.

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.

Effects of a Community-Based HIV Risk Reduction Intervention Among HIV-Positive Individuals: Results of a Quasi-Experimental Study in Nepal.

We evaluated the efficacy of a sexual risk reduction intervention utilizing protection motivation and social cognitive theories to address knowledge, threat and coping appraisals, and condom use intentions among HIV-positive individuals in Nepal. Using a quasi-experimental research design, we assigned 277 participants to intervention (n=146) and control (n=131) groups. The intervention group received six sessions on sexual risk reduction strategies and the control group six sessions on medication adherence, smoking, and mental health. Data were collected at baseline and immediately after the intervention. Results indicate that the sexual risk reduction intervention produced a significant increase in HIV transmission knowledge, perceived threat and coping appraisals, and intentions to use condoms with regular, HIV-positive, and HIV-negative partners. The positive effects of the intervention remained significant after adjusting for baseline scores and other potential confounders. In conclusion, our theory-based sexual risk reduction intervention was effective in improving HIV transmission knowledge, perceived threat and coping appraisals, and condom use intentions. Further studies are needed to evaluate the long-term efficacy of the intervention in increasing protection motivation and maintaining preventive behaviors.

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.

Comparative effectiveness of a multifaceted intervention to improve adherence to annual colorectal cancer screening in community health centers: a randomized clinical trial.

IMPORTANCE: Colorectal cancer (CRC) screening rates are lower among Latinos and people living in poverty. Fecal occult blood testing (FOBT) is one recommended screening modality that may overcome cost and access barriers. However, the ability of FOBT to reduce CRC mortality depends on high rates of adherence to annual screening. OBJECTIVE: To determine whether a multifaceted intervention increases adherence to annual FOBT compared with usual care. DESIGN, SETTING, AND PARTICIPANTS: Patient-level randomized controlled trial conducted in a network of community health centers. Included were 450 patients who had previously completed a home FOBT from March 2011 through February 2012 and had a negative test result: 72% of participants were women; 87% were Latino; 83% stated that Spanish was their preferred language; and 77% were uninsured. INTERVENTIONS: Usual care at participating health centers included computerized reminders, standing orders for medical assistants to give patients home fecal immunochemical tests (FIT), and clinician feedback on CRC screening rates. The intervention group also received (1) a mailed reminder letter, a free FIT with low-literacy instructions, and a postage-paid return envelope; (2) an automated telephone and text message reminding them that they were due for screening and that a FIT was being mailed to them; (3) an automated telephone and text reminder 2 weeks later for those who did not return the FIT; and (4) personal telephone outreach by a CRC screening navigator after 3 months. MAIN OUTCOMES AND MEASURES: Completion of FOBT within 6 months of the date the patient was due for annual screening. RESULTS: Intervention patients were much more likely than those in usual care to complete FOBT (82.2% vs 37.3%; P < .001). Of the 185 intervention patients completing screening, 10.2% completed prior to their due date (intervention was not given), 39.6% within 2 weeks (after initial intervention), 24.0% within 2 to 13 weeks (after automated call/text reminder), and 8.4% between 13 and 26 weeks (after personal call). CONCLUSIONS AND RELEVANCE: This intervention greatly increased adherence to annual CRC screening; most screenings were achieved without personal calls. It is possible to improve annual CRC screening for vulnerable populations with relatively low-cost strategies that are facilitated by health information technologies. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT01453894.

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.

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.

Challenges and recommendations for advancing the state-of-the-science of quality of life assessment in symptom management trials.

Major findings are presented from a workshop on Quality of Life Assessment in Cancer Symptom Management Trials, sponsored by the National Cancer Institute. Data-driven research reports focused on 3 topics, 1) the rationale and utility of health-related quality of life (HRQOL) assessment, 2) conceptual models, and 3) measurement and design issues. Recommendations for including HRQOL assessment cited the potential value of: capturing additional treatment effects (eg, fatigue + depression); describing the patient experience; predicting patient prognosis; identifying potential adverse effects; observing interactions among symptoms; calculating quality adjusted survival and cost-effectiveness; and generating new hypotheses. Recommendations for developing more fully developed conceptual models focused on maintaining clear distinctions among symptoms, function, summary measures of HRQOL, and global HRQOL assessments; identifying symptom clusters; pursuing hypotheses about whether clustering is better explained as symptom-related or as patient-related (genetic predispositions); and gaining a better understanding of the dynamic and reciprocal influences of symptoms on each other. With respect to measurement and design issues, because different HRQOL measures cover different domains with various degrees of sensitivity, there is a need to select measures that are carefully tailored to the study's hypotheses. Finally, there is a growing appreciation that trials must be powered to test for effects on secondary endpoints.

A multi-city community based smoking research intervention project in the African-American population.

OBJECTIVE: To carry out a community-based research approach to determine the most effective educational interventions to reduce smoking among African-American smokers. The intervention included preparation of the community, planning and developing a model of change, and developing a community-based intervention. The study population consisted of 2,544 randomly selected adult African-American smokers residing in four sites in the northeastern and southeastern parts of the United States. The research design provided a comparison of active intervention sites with passive control sites as well as low income and moderate income areas. MAJOR OUTCOME MEASURES: Point prevalence of non-smoking at the time of interview; Period prevalence of non-smoking at the time of interview; Period prevalence of quit attempts in the prior six months; Number of smoke-free days in the prior six months; Number of cigarettes smoked daily at the time of interview. RESULTS: Based upon a survey eighteen months after baseline data was collected, all four measures of cigarette smoking behavior showed a strong statistically significant reduction of personal smoking behavior among those receiving active interventions versus the passive group. On the basis of process variable analysis, direct contact with the project staff in the prior six months was significantly higher in the active intervention areas. There was only a small non-significant increase in personal smoking behavior in moderate income groups as opposed to low income groups. CONCLUSION: An analysis of process variables strongly suggests that, within this African-American Community, "hands on" or "face to face" approaches along with mass media, mailings, and other less personal approaches were more effective in reducing personal smoking behavior than media, mailings, and other impersonal approaches alone addressed to large audiences.

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.

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.