Beverly B. Green

Time to colonoscopy after positive fecal blood test in four U.S. health care systems

Background: To reduce colorectal cancer mortality, positive fecal blood tests must be followed by colonoscopy. Methods: We identified 62,384 individuals ages 50 to 89 years with a positive fecal blood test between January 1, 2011 and December 31, 2012 in four health care systems within the Population-Based Research Optimizing Screening through Personalized Regimens (PROSPR) consortium. We estimated the probability of follow-up colonoscopy and 95% confidence intervals (CI) using the Kaplan–Meier method. Overall differences in cumulative incidence of follow-up across health care systems were assessed with the log-rank test. HRs and 95% CIs were estimated from multivariate Cox proportional hazards models. Results: Most patients who received a colonoscopy did so within 6 months of their positive fecal blood test, although follow-up rates varied across health care systems (P <0.001). Median days to colonoscopy ranged from 41 (95% CI, 40–41) to 174 (95% CI, 123–343); percent followed-up by 12 months ranged from 58.1% (95% CI, 51.6%–63.7%) to 83.8% (95% CI, 83.4%–84.3%) and differences across health care systems were also observed at 1, 2, 3, and 6 months. Increasing age and comorbidity score were associated with lower follow-up rates. Conclusion: Individual characteristics and health care system were associated with colonoscopy after positive fecal blood tests. Patterns were consistent across health care systems, but proportions of patients receiving follow-up varied. These findings suggest that there is room to improve follow-up of positive colorectal cancer screening tests. Impact: Understanding the timing of colonoscopy after positive fecal blood tests and characteristics associated with lack of follow-up may inform future efforts to improve follow-up. Cancer Epidemiol Biomarkers Prev; 25(2); 344–50. ©2016 AACR.

Self-monitoring of blood pressure in hypertension: A systematic review and individual patient data meta-analysis

Background Self-monitoring of blood pressure (BP) appears to reduce BP in hypertension but important questions remain regarding effective implementation and which groups may benefit most. This individual patient data (IPD) meta-analysis was performed to better understand the effectiveness of BP self-monitoring to lower BP and control hypertension. Methods and findings Medline, Embase, and the Cochrane Library were searched for randomised trials comparing self-monitoring to no self-monitoring in hypertensive patients (June 2016). Two reviewers independently assessed articles for eligibility and the authors of eligible trials were approached requesting IPD. Of 2,846 articles in the initial search, 36 were eligible. IPD were provided from 25 trials, including 1 unpublished study. Data for the primary outcomes—change in mean clinic or ambulatory BP and proportion controlled below target at 12 months—were available from 15/19 possible studies (7,138/8,292 [86%] of randomised participants). Overall, self-monitoring was associated with reduced clinic systolic blood pressure (sBP) compared to usual care at 12 months (−3.2 mmHg, [95% CI −4.9, −1.6 mmHg]). However, this effect was strongly influenced by the intensity of co-intervention ranging from no effect with self-monitoring alone (−1.0 mmHg [−3.3, 1.2]), to a 6.1 mmHg (−9.0, −3.2) reduction when monitoring was combined with intensive support. Self-monitoring was most effective in those with fewer antihypertensive medications and higher baseline sBP up to 170 mmHg. No differences in efficacy were seen by sex or by most comorbidities. Ambulatory BP data at 12 months were available from 4 trials (1,478 patients), which assessed self-monitoring with little or no co-intervention. There was no association between self-monitoring and either lower clinic or ambulatory sBP in this group (clinic −0.2 mmHg [−2.2, 1.8]; ambulatory 1.1 mmHg [−0.3, 2.5]). Results for diastolic blood pressure (dBP) were similar. The main limitation of this work was that significant heterogeneity remained. This was at least in part due to different inclusion criteria, self-monitoring regimes, and target BPs in included studies. Conclusions Self-monitoring alone is not associated with lower BP or better control, but in conjunction with co-interventions (including systematic medication titration by doctors, pharmacists, or patients; education; or lifestyle counselling) leads to clinically significant BP reduction which persists for at least 12 months. The implementation of self-monitoring in hypertension should be accompanied by such co-interventions.

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

BackgroundColorectal-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.MethodsThe 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.ResultsThe 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%).ConclusionsFindings 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 registrationClinicalTrial.gov: NCT01742065

Strategies and Opportunities to STOP Colon Cancer in Priority Populations: design of a cluster-randomized pragmatic trial.

BACKGROUND Colorectal cancer is the second-leading cause of cancer deaths in the United States. The Strategies and Opportunities to Stop Colorectal Cancer (STOP CRC) in Priority Populations study is a pragmatic trial and a collaboration between two research institutions and a network of more than 200 safety net clinics. The study will assess the effectiveness of a system-based intervention designed to improve the rates of colorectal-cancer screening using fecal immunochemical testing (FIT) in federally qualified health centers in Oregon and Northern California. MATERIAL AND METHODS STOP CRC is a cluster-randomized comparative-effectiveness pragmatic trial enrolling 26 clinics. Clinics will be randomized to one of two arms. Clinics in the intervention arm (1) will use an automated, data-driven, electronic health record-embedded program to identify patients due for colorectal screening and mail FIT kits (with pictographic instructions) to them; (2) will conduct an improvement process (e.g. Plan-Do-Study-Act) to enhance the adoption, reach, and effectiveness of the program. Clinics in the control arm will provide opportunistic colorectal-cancer screening to patients at clinic visits. The primary outcomes are: proportion of age- and screening-eligible patients completing a FIT within 12months; and cost, cost-effectiveness, and return on investment of the intervention. CONCLUSIONS This large-scale pragmatic trial will leverage electronic health record information and existing clinic staff to enroll a broad range of patients, including many with historically low colorectal-cancer screening rates. If successful, the program will provide a model for a cost-effective and scalable method to raise colorectal-cancer screening rates.

Patterns of Colorectal Cancer Screening Uptake in Newly Eligible Men and Women

Background: We describe patterns of colorectal cancer screening uptake in a U.S. insured population as individuals become newly eligible for screening at age 50 and assess temporal trends and patient characteristics with screening uptake. Methods: We identified a cohort of 81,223 men and women who were members of Group Health and turned 50 years old from 1996 to 2010. We ascertained receipt of colorectal cancer screening within five years. Time to screening was estimated by year of cohort entry using cumulative incidence curves and Cox proportional hazards models–estimated patient characteristics associated with screening uptake. Results: Stool-based screening tests were the most common, 72% of first screening tests. The proportion of individuals initiating colorectal cancer screening via colonoscopy increased from 8% in 1996 to 1998 to 33% in 2008 to 2010. Patient factors associated with increased colorectal cancer screening were: turning 50 more recently (2008–2010; Ptrend < 0.0001) or Asian race [HR, 1.14; 95% confidence interval (CI), 1.10–1.19]. Patient factors associated with decreased screening were: being a woman (HR, 0.70; 95% CI, 0.68–0.72), Native American (HR, 0.68; 95% CI, 0.60–0.78), or Pacific Islander race (HR, 0.82; 95% CI, 0.72–0.95), and having prevalent diabetes (HR, 0.78; 95% CI, 0.75–0.82) and higher body mass index (Ptrend < 0.0001). Conclusions: Patient characteristics associated with initiation of colorectal cancer screening in a newly eligible population are similar to characteristics associated with overall screening participation in all age-eligible adults. Our results identify patient populations to target in outreach programs. Impact: Disparities in receipt of colorectal cancer screening are evident from onset of an age-eligible cohort, identifying key groups for future interventions for screening. Cancer Epidemiol Biomarkers Prev; 23(7); 1230–7. ©2014 AACR.

Pragmatic clinical trials embedded in healthcare systems: generalizable lessons from the NIH Collaboratory

BackgroundThe clinical research enterprise is not producing the evidence decision makers arguably need in a timely and cost effective manner; research currently involves the use of labor-intensive parallel systems that are separate from clinical care. The emergence of pragmatic clinical trials (PCTs) poses a possible solution: these large-scale trials are embedded within routine clinical care and often involve cluster randomization of hospitals, clinics, primary care providers, etc. Interventions can be implemented by health system personnel through usual communication channels and quality improvement infrastructure, and data collected as part of routine clinical care. However, experience with these trials is nascent and best practices regarding design operational, analytic, and reporting methodologies are undeveloped.MethodsTo strengthen the national capacity to implement cost-effective, large-scale PCTs, the Common Fund of the National Institutes of Health created the Health Care Systems Research Collaboratory (Collaboratory) to support the design, execution, and dissemination of a series of demonstration projects using a pragmatic research design.ResultsIn this article, we will describe the Collaboratory, highlight some of the challenges encountered and solutions developed thus far, and discuss remaining barriers and opportunities for large-scale evidence generation using PCTs.ConclusionA planning phase is critical, and even with careful planning, new challenges arise during execution; comparisons between arms can be complicated by unanticipated changes. Early and ongoing engagement with both health care system leaders and front-line clinicians is critical for success. There is also marked uncertainty when applying existing ethical and regulatory frameworks to PCTS, and using existing electronic health records for data capture adds complexity.

Reasons for non-response to a direct-mailed FIT kit program: lessons learned from a pragmatic colorectal-cancer screening study in a federally sponsored health center.

Colorectal cancer screening rates are below optimal. As part of a pilot clinic-based pragmatic study aiming to raise rates of colorectal-cancer screening, we explored patients’ reasons for not responding to a direct-mailed screening invitation. We conducted telephone interviews with patients who were mailed a fecal immunochemical test (FIT) but who did not return it to the lab. Interviews were audio-recorded, transcribed, and coded for thematic analysis. We met our goal of 20 interviews (10 in English and 10 Spanish; 75 % female). Reasons for not completing tests were fear of results or cost of follow-up colonoscopy (n = 9); not having received the test in the mail (n = 7); concerns about mailing fecal matter or that test results could be mixed up (n = 6); and being busy or forgetful (n = 4). Efforts to improve uptake of colorectal cancer screening in a direct-mailed program ought to address concerns identified in our study.

Recruiting community health centers into pragmatic research: Findings from STOP CRC

Background: Challenges of recruiting participants into pragmatic trials, particularly at the level of the health system, remain largely unexplored. As part of Strategies and Opportunities to STOP Colon Cancer in Priority Populations (STOP CRC), we recruited eight separate community health centers (consisting of 26 individual safety net clinics) into a large comparative effectiveness pragmatic study to evaluate methods of raising the rates of colorectal cancer screening. Methods: In partnership with STOP CRC’s advisory board, we defined criteria to identify eligible health centers and applied these criteria to a list of health centers in Washington, Oregon, and California affiliated with Oregon Community Health Information Network, a 16-state practice-based research network of federally sponsored health centers. Project staff contacted centers that met eligibility criteria and arranged in-person meetings of key study investigators with health center leadership teams. We used the Consolidated Framework for Implementation Research to thematically analyze the content of discussions during these meetings to identify major facilitators of and barriers to health center participation. Results: From an initial list of 41 health centers, 11 met the initial inclusion criteria. Of these, leaders at three centers declined and at eight centers (26 clinic sites) agreed to participate (73%). Participating and nonparticipating health centers were similar with respect to clinic size, percent Hispanic patients, and percent uninsured patients. Participating health centers had higher proportions of Medicaid patients and higher baseline colorectal cancer screening rates. Common facilitators of participation were perception by center leadership that the project was an opportunity to increase colorectal cancer screening rates and to use electronic health record tools for population management. Barriers to participation were concerns of center leaders about ability to provide fecal testing to and assure follow-up of uninsured patients, limited clinic capacity to prepare mailings required by the study protocol, discomfort with randomization, and concerns about delaying program implementation at some clinics due to the research requirements. Conclusion: Our findings address an important research gap and may inform future efforts to recruit community health centers into pragmatic research.

Follow-Up of Abnormal Breast and Colorectal Cancer Screening by Race/Ethnicity

INTRODUCTION Timely follow-up of abnormal tests is critical to the effectiveness of cancer screening, but may vary by screening test, healthcare system, and sociodemographic group. METHODS Timely follow-up of abnormal mammogram and fecal occult blood testing or fecal immunochemical tests (FOBT/FIT) were compared by race/ethnicity using Population-Based Research Optimizing Screening through Personalized Regimens consortium data. Participants were women with an abnormal mammogram (aged 40-75 years) or FOBT/FIT (aged 50-75 years) in 2010-2012. Analyses were performed in 2015. Timely follow-up was defined as colonoscopy ≤3 months following positive FOBT/FIT; additional imaging or biopsy ≤3 months following Breast Imaging Reporting and Data System Category 0, 4, or 5 mammograms; or ≤9 months following Category 3 mammograms. Logistic regression was used to model receipt of timely follow-up adjusting for study site, age, year, insurance, and income. RESULTS Among 166,602 mammograms, 10.7% were abnormal; among 566,781 FOBT/FITs, 4.3% were abnormal. Nearly 96% of patients with abnormal mammograms received timely follow-up versus 68% with abnormal FOBT/FIT. There was greater variability in receipt of follow-up across healthcare systems for positive FOBT/FIT than for abnormal mammograms. For mammography, black women were less likely than whites to receive timely follow-up (91.8% vs 96.0%, OR=0.71, 95% CI=0.51, 0.97). For FOBT/FIT, Hispanics were more likely than whites to receive timely follow-up than whites (70.0% vs 67.6%, OR=1.12, 95% CI=1.04, 1.21). CONCLUSIONS Timely follow-up among women was more likely for abnormal mammograms than FOBT/FITs, with small variations in follow-up rates by race/ethnicity and larger variation across healthcare systems.

Factors associated with use and non-use of the Fecal Immunochemical Test (FIT) kit for Colorectal Cancer Screening in Response to a 2012 outreach screening program: a survey study

BackgroundThe one-sample fecal immunochemical test (FIT) is gaining popularity for colorectal cancer (CRC) screening of average-risk people. However, uptake and annual use remain suboptimal.MethodsIn 2013, we mailed questionnaires to three groups of nonHispanic White, Black, and Latino Kaiser Permanente Northern California (KPNC) members ages 52–76 who received FIT kits in 2010–2012: Continuers did the FIT all 3 years; Converts in 2012, but not 2010 or 2011; and Nonusers in none of the 3 years. The questionnaires covered social influences, perceived CRC risk, reasons for using (Continuers, Converts) or avoiding using (Nonusers) the FIT, and recommendations for improving the kit.ResultsContinuers (n = 607, response rate 67.5 %), Converts (n = 317, response rate 35.6 %), and Nonusers (n = 215, response rate 21.1 %) did not differ in perceived risk or family history of CRC, but Nonusers were less likely than Continuers and Converts to know someone who had polyps or CRC. Continuers, Converts, and Nonusers did not differ in social network encouragement of CRC screening, but did differ in believing that it was very important that they be screened (88.3 %, 68.4 %, 47.7 %) and that their medical team thought it very important that they be screened (88.6 %, 79.9 %, 53.9 %). Approximately half of Continuers and Converts completed the FIT to please their doctor. Converts were less likely than Continuers to use the FIT to “make sure they were OK” (53.7 % vs. 72.6 %) or “protect their health” (46.1 % vs. 76.4 %). Nearly half of Converts completed the FIT out of guilt. Approximately half of FIT kit users suggested adding a disposable glove, extra paper, and wider-mouth tube to the kit. Nonusers’ reasons for not using the FIT included discomfort, disgust, or embarrassment (59.6 %); thinking it unnecessary (32.9 %); fatalism/fear (15.5 %); and thinking it too difficult to use (14.5 %), but <10 % did not want CRC screening at all.ConclusionsNonusers and irregular users of the FIT are less intrinsically motivated to get CRC screening than long-term users and more averse to preparing their stool sample. Changes to the FIT kit to address discomfort and difficulty factors might improve uptake and continued use.