Positive predictive values of fecal immunochemical tests used in the STOP CRC pragmatic trial.

Annual fecal immunochemical testing (FIT) is cost-effective for colorectal cancer (CRC) screening. However, FIT positivity rates and positive predictive value (PPV) can vary substantially, with false-positive (FP) results adding to colonoscopy burden without improving cancer detection. Our objective was to describe FIT PPV and the factors associated with FP results among patients undergoing CRC screening. In an ongoing pragmatic clinical trial of mailed-FIT outreach, clinics delivered one of three FIT brands (InSure, OC-Micro, and Hemosure). Patients who had a positive FIT result and a follow-up colonoscopy were included in this analysis (N = 1130). Patients' demographic and medical histories were abstracted from electronic health records (EHR). Associations with a FP result (ie, a positive FIT result with no evidence of advanced neoplasia during follow-up colonoscopy) were evaluated for FIT brand and patient factors using mixed-effects multivariable logistic regression. The mean proportion of FIT-positive results ranged from 8% in centers using the OC-Micro test to 21% for Hemosure. PPVs for advanced neoplasia were 0.30 to 0.17, respectively (P for χ2  = 0.08). In multivariable-adjusted models, use of Hemosure was associated with greater odds of a FP result than OC-Micro (OR = 2.00, 95% CI: 0.47-8.56) or InSure (OR = 1.72, 95% CI: 0.44-6.68). However, only female sex (OR = 1.58, 95% CI: 1.19-2.10) and history of a colorectal condition (OR = 2.17, 95% CI: 1.13-4.15) were significantly associated with FP. In conclusion, FIT positivity varied by brand, and FP results differed by patient factors available through the EHR. These results can be used to minimize the frequency of FP results, reducing patient distress and colonoscopy burden.

In Low-Income Latino Patients, Post-Affordable Care Act Insurance Disparities May Be Reduced Even More than Broader National Estimates: Evidence from Oregon.

BACKGROUND: Early survey evidence suggests a reduction of disparities in insurance coverage between Latinos and non-Hispanic Whites post-Affordable Care Act (ACA). These findings may not describe the insurance status of vulnerable, low-income Latino populations served in community health centers (CHCs) over the course of this policy change. Cross-sectional surveys also may be of limited use in describing longitudinal phenomena such as changes in health insurance status. METHODS: Using electronic health record (EHR) data, we compared the insurance status of N = 42,392 low-income patients served in 23 CHCs in Oregon, by race/ethnicity and language, over a period of 6 years straddling the implementation of ACA-related Medicaid expansion on January 1, 2014. FINDINGS: Prior to 2014, Spanish-preferring Latinos were more likely to be uninsured than English-preferring Latinos and non-Hispanic Whites. Among uninsured patients who returned for at least one visit in 2014, Spanish-preferring Latinos had the largest increase in insurance coverage rates, and all three racial/ethnic/language groups had similar rates of insurance coverage. There were no racial/ethnic/language differences between those who did and did not have visit in 2014. CONCLUSION: Among previously uninsured low-income patients returning to Oregon CHCs, insurance disparities were eliminated after Medicaid expansion, especially in Spanish-speaking Latinos. Further study is needed to understand the elimination of insurance disparities in this cohort.

Timeliness of Colonoscopy After Abnormal Fecal Test Results in a Safety Net Practice.

Fecal testing can only reduce colorectal cancer mortality if patients with an abnormal test result receive a follow-up colonoscopy. As part of the Strategies and Opportunities to STOP Colon Cancer in Priority Populations (STOP CRC) project, we examined factors associated with adherence to follow-up colonoscopy among patients with abnormal fecal test results. As part of STOP CRC outreach, Virginia Garcia Memorial Health Center staff distributed 1753 fecal immunochemical tests (FIT), of which 677 (39 %) were completed, and 56 had an abnormal result (8 %). Project staff used logistic regression analyses to examine factors associated with colonoscopy referral and completion. Of the 56 patients with abnormal FIT results; 45 (80 %) had evidence of a referral for colonoscopy, 32 (57 %) had evidence of a completed colonoscopy within 18 months, and 14 (25 %) within 60 days of an abnormal fecal test result. In adjusted analysis, Hispanics had lower odds of completing follow-up colonoscopy within 60 days than non-Hispanic whites (adjusted OR 0.20; 95 % CI 0.04, 0.92). Colonoscopy within 60 days trended lower for women than for men (adjusted OR 0.25; 95 % CI 0.06-1.04). Among the 24 patients lacking medical record evidence of a colonoscopy, 19 (79 %) had a documented reason, including clinician did not pursue, patient refused, and colonoscopy not indicated. No reason was found for 21 %. Improvements are needed to increase rates of follow-up colonoscopy completion, especially among female and Hispanic patients.

Using an Automated Data-driven, EHR-Embedded Program for Mailing FIT kits: Lessons from the STOP CRC Pilot Study.

BACKGROUND: The Strategies and Opportunities to Stop Colorectal Cancer (STOP CRC) study is collaboration among two research institutions and health-systems partners. The main study, scheduled to begin in 2014, will assess effectiveness of an intervention program using electronic health record (EHR) clinical decision support (CDS) tools to improve rates of colorectal-cancer screening in federally qualified health centers (FQHCs). Very few studies, and no large studies, aimed at raising CRC screening rates have utilized an EHR-embedded system. STUDY DESIGN: We piloted the use of an EHR-embedded real-time patient registry reporting tool in a pilot study undertaken prior to beginning our main CRC screening study. The pilot study goal was to assess feasibility and effectiveness of two clinic-based approaches to raising rates of colorectal cancer screening among selected patients aged 50-74 who were not up-to-date with colorectal-cancer screening guidelines. We used work sessions and qualitative interviews with clinic personnel to assess performance of the tool, as well as to identify specific elements of the tool's functionality needing refinement. RESULTS: Two critical elements of the EHR tool allowed us to mail FIT kits efficiently to appropriate patients: (1) having a direct interface with the laboratory that processed the FITs, thus allowing for real-time updates to the registry; and (2) being able to place lab orders from a list of selected patients. We identified the following elements that needed refining: the use of Health Maintenance (EHR function for tracking screening eligibility and due dates incorporating STOP CRC inclusion and exclusion criteria), and the development of report templates for identifying patients eligible for each step. CONCLUSION: We found that most elements of our EHR-embedded program worked well and that specific refinement may improve the accuracy of identifying patients at each step. Our findings can inform future efforts to build EHR-embedded CDS tools for preventive services.

Strategies and opportunities to STOP colon cancer in priority populations: pragmatic pilot study design and outcomes.

BACKGROUND: Colorectal-cancer is a leading cause of cancer death in the United States, and Latinos have particularly low rates of screening. Strategies and Opportunities to STOP Colon Cancer in Priority Populations (STOP CRC) is a partnership among two research institutions and a network of safety net clinics to promote colorectal cancer screening among populations served by these clinics. This paper reports on results of a pilot study conducted in a safety net organization that serves primarily Latinos. METHODS: The study assessed two clinic-based approaches to raise rates of colorectal-cancer screening among selected age-eligible patients not up-to-date with colorectal-cancer screening guidelines. One clinic each was assigned to: (1) an automated data-driven Electronic Health Record (EHR)-embedded program for mailing Fecal Immunochemical Test (FIT) kits (Auto Intervention); or (2) a higher-intensity program consisting of a mailed FIT kit plus linguistically and culturally tailored interventions delivered at the clinic level (Auto Plus Intervention). A third clinic within the safety-net organization was selected to serve as a passive control (Usual Care). Two simple measurements of feasibility were: 1) ability to use real-time EHR data to identify patients eligible for each intervention step, and 2) ability to offer affordable testing and follow-up care for uninsured patients. RESULTS: The study was successful at both measurements of feasibility. A total of 112 patients in the Auto clinic and 101 in the Auto Plus clinic met study inclusion criteria and were mailed an introductory letter. Reach was high for the mailed component (92.5% of kits were successfully mailed), and moderate for the telephone component (53% of calls were successful completed). After exclusions for invalid address and other factors, 206 (109 in the Auto clinic and 97 in the Auto Plus clinic) were mailed a FIT kit. At 6 months, fecal test completion rates were higher in the Auto (39.3%) and Auto Plus (36.6%) clinics compared to the usual-care clinic (1.1%). CONCLUSIONS: Findings showed that the trial interventions delivered in a safety-net setting were both feasible and raised rates of colorectal-cancer screening, compared to usual care. Findings from this pilot will inform a larger pragmatic study involving multiple clinics. TRIAL REGISTRATION: ClinicalTrial.gov: NCT01742065.

Advantages of wordless instructions on how to complete a fecal immunochemical test: lessons from patient advisory council members of a federally qualified health center.

Some patients face difficulty understanding instructions for completing the fecal immunochemical test (FIT), a self-administered test to screen for colorectal cancer. We sought to develop and test low-literacy instructions for completing the FIT. Working in partnership with a Latino-serving Federally Qualified Health Center (FQHC) in the Portland Metro area, we developed and tested low-literacy instructions for completing the FIT; the instructions contained seven words (mail within 3 days; Devolver dentro de 3 dias). We conducted focus groups of Spanish-speaking patients on the advisory council of our partnering FQHC organization, and we gathered feedback from the project's advisory board members and clinic staff. We mailed a FIT kit to each patient, along with either (a) instructions written in English and Spanish, consisting of 415 words; or (b) low-literacy "wordless" instructions. We asked patients to complete the test before providing feedback. Our qualitative assessment showed that the wordless instructions were preferred over instructions consisting of words. Wordless instructions might aid efforts to raise the rates of colorectal cancer screening among low-literacy and non-English-speaking populations.

Comparative effectiveness topics from a large, integrated delivery system.

OBJECTIVE: To identify high-priority comparative effectiveness questions directly relevant to care delivery in a large, US integrated health care system. METHODS: In 2010, a total of 792 clinical and operational leaders in Kaiser Permanente were sent an electronic survey requesting nominations of comparative effectiveness research questions; most recipients (83%) had direct clinical roles. Nominated questions were divided into 18 surveys of related topics that included 9 to 23 questions for prioritization. The next year, 648 recipients were electronically sent 1 of the 18 surveys to prioritize nominated questions. Surveys were assigned to recipients on the basis of their nominations or specialty. High-priority questions were identified by comparing the frequency a question was selected to an "expected" frequency, calculated to account for the varying number of questions and respondents across prioritization surveys. High-priority questions were those selected more frequently than expected. RESULTS: More than 320 research questions were nominated from 181 individuals. Questions most frequently addressed cardiovascular and peripheral vascular disease; obesity, diabetes, endocrinology, and metabolic disorders; or service delivery and systems-level questions. Ninety-five high-priority research questions were identified, encompassing a wide range of health questions that ranged from prevention and screening to treatment and quality of life. Many were complex questions from a systems perspective regarding how to deliver the best care. CONCLUSIONS: The 95 questions identified and prioritized by leaders on the front lines of health care delivery may inform the national discussion regarding comparative effectiveness research. Additionally, our experience provides insight in engaging real-world stakeholders in setting a health care research agenda.

Perceptions of under and overutilization of cervical cancer screening services at Latino-serving community health centers.

We sought to gather the perceptions of clinic personnel at Latino-serving Federally Qualified Health Centers (FQHCs) about patients' utilization of screening services for cervical cancer. We conducted one-on-one interviews among 17 clinic personnel at four Latino-serving FQHCs in Oregon. The clinic personnel we interviewed observed both under and overutilization of cervical cancer screening services. Clinic personnel estimated that 20-60 % of eligible patients were underscreened for cervical cancer, with 30 % the most commonly cited percentage. Underscreening was thought to occur among low-income, underinsured, and undocumented patients. Overscreening for cervical cancer was estimated to occur in 10-50 % of eligible patients, with 10 % the most frequently cited proportion. Overscreening was thought to occur among women younger than age 21 and women with a recent pregnancy. Our findings may inform future efforts to promote guideline-appropriate cancer screening and coordinated follow-up care.

Effectiveness of primary care-relevant treatments for obesity in adults: a systematic evidence review for the U.S. Preventive Services Task Force.

BACKGROUND: Overweight and obesity in adults are common and adversely affect health. PURPOSE: To summarize effectiveness and harms of primary care-relevant weight-loss interventions for overweight and obese adults. DATA SOURCES: MEDLINE, Cochrane Central Register of Controlled Trials, and PsycINFO from January 2005 to September 2010; systematic reviews for identifying trials before 2005. STUDY SELECTION: Two investigators appraised 6498 abstracts and 648 articles. Clinical trials were included if control groups received minimal interventions. Articles were rated as good, fair, or poor by using design-specific criteria. DATA EXTRACTION: One investigator abstracted study characteristics and findings for good- and fair-quality studies; a second checked them. DATA SYNTHESIS: Behaviorally based treatment resulted in 3-kg (6.6-lb) greater weight loss in intervention than control participants after 12 to 18 months, with more treatment sessions associated with greater loss. Limited data suggest weight-loss maintenance for 1 year or more. Orlistat plus behavioral intervention resulted in 3-kg (6.6-lb) more weight loss than did placebo after 12 months. Metformin resulted in less weight loss. Data on effects of weight-loss treatment on long-term health outcomes (for example, death and cardiovascular disease) were insufficient. Weight-loss treatment reduced diabetes incidence in participants with prediabetes. Effects on intermediate outcomes (for example, lipids and blood pressure) were mixed and small. Data on serious medication harms were insufficient. Medications commonly caused withdrawals due to gastrointestinal symptoms. LIMITATIONS: Few studies reported health outcomes. Behaviorally based treatments were heterogeneous and specific elements were not well-described. Many studies could not be pooled because of insufficient reporting of variance data. Medication trials had high attrition, lacked postdiscontinuation data, and were inadequately powered for rare adverse effects. CONCLUSION: Behaviorally based treatments are safe and effective for weight loss and maintenance. PRIMARY FUNDING SOURCE: Agency for Healthcare Research and Quality.