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Background: The US Preventive Services Task Force recommends blood pressure (BP) measurements using 24-h ambulatory monitoring (ABPM) or home BP monitoring before making a new hypertension diagnosis. Objective: Compare clinic-, home-, and kiosk-based BP measurement to ABPM for diagnosing hypertension. Design, Setting, and Participants: Diagnostic study in 12 Washington State primary care centers, with participants aged 18–85 years without diagnosed hypertension or prescribed antihypertensive medications, with elevated BP in clinic. Interventions: Randomization into one of three diagnostic regimens: (1) clinic (usual care follow-up BPs); (2) home (duplicate BPs twice daily for 5 days); or (3) kiosk (triplicate BPs on 3 days). All participants completed ABPM at 3 weeks. Main Measures: Primary outcome was difference between ABPM daytime and clinic, home, and kiosk mean systolic BP. Differences in diastolic BP, sensitivity, and specificity were secondary outcomes. Key Results: Five hundred ten participants (mean age 58.7 years, 80.2% white) with 434 (85.1%) included in primary analyses. Compared to daytime ABPM, adjusted mean differences in systolic BP were clinic (−4.7mmHg [95% confidence interval −7.3, −2.2]; P<.001); home (−0.1mmHg [−1.6, 1.5];P=.92); and kiosk (9.5mmHg [7.5, 11.6];P<.001). Differences for diastolic BP were clinic (−7.2mmHg [−8.8, −5.5]; P<.001); home (−0.4mmHg [−1.4, 0.7];P=.52); and kiosk (5.0mmHg [3.8, 6.2]; P<.001). Sensitivities for clinic, home, and kiosk compared to ABPM were 31.1% (95% confidence interval, 22.9, 40.6), 82.2% (73.8, 88.4), and 96.0% (90.0, 98.5), and specificities 79.5% (64.0, 89.4), 53.3% (38.9, 67.2), and 28.2% (16.4, 44.1), respectively. Limitations: Single health care organization and limited race/ethnicity representation. Conclusions: Compared to ABPM, mean BP was significantly lower for clinic, significantly higher for kiosk, and without significant differences for home. Clinic BP measurements had low sensitivity for detecting hypertension. Findings support utility of home BP monitoring for making a new diagnosis of hypertension. Trial Registration: ClinicalTrials.gov NCT03130257 https://clinicaltrials.gov/ct2/show/NCT03130257 [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

Background: Many trials have tested different strategies to increase colorectal cancer (CRC) screening. Few describe whether participants are representative of the population from which they are recruited. Purpose: To determine risk factors related to nonparticipation among patients enrolled in an integrated health plan and not up to date for CRC testing, in a trial to increase screening rates. Methods: Between July 2008 and October 2009, a total of 15,000 adults aged 50–74 years from 21 clinics in Washington State who were due for CRC screening were contacted. Nonparticipants were defined as English-speaking patients who did not engage in the call or refused participation while still potentially eligible. Log-binomial regression models were used to estimate the relative risk of nonparticipation. Analyses were completed between October 2010 and June 2011. Results: Patients who were nonwhite, had less education, used tobacco, had less continuity of care, and had lower rates of preventive care and cancer screening were more likely to be nonparticipants. Patients reporting never having received any type of CRC testing or screening were also more likely not to participate (62% of nonparticipants vs 46% of participants; adjusted RR=1.58, 95% CI=1.47, 1.70). Reasons for refusal included costs, risks of procedures, and not wanting their medical records reviewed. Conclusions: Patients eligible for but not participating in the trial were more likely to be from minority socioeconomic and racial groups and had behaviors that can negatively affect cancer outcomes. Additional efforts are needed to recruit patients who need CRC screening the most. Trial registration: This trial is registered at clinicaltrials.gov NCT 00697047. [Copyright &y& Elsevier]

Objective: The aim of this study is to compare the uptake of three mailed high-sensitivity fecal occult blood tests (FOBTs). Methods: We conducted a parallel 3-arm randomized controlled trial in an integrated healthcare delivery system in Washington State. From January 2010 through February 2011, automated data were used to identify potentially eligible patients aged 50–74 due for colorectal cancer screening. Participants were mailed one of three FOBT kits (1-sample OC-Auto® fecal immunochemical test [FIT], 2-sample InSure® FIT, or 3-sample guaiac Hemoccult SENSA®), instructions, and a postage-paid return envelope. We performed a modified intent-to-treat analysis with return of any FOBT within 6months of randomization as the primary outcome. Results: Of the 9922 people invited, 2873 returned surveys, 2263 were randomized, and 2234 were analyzed. FOBTs were returned by 1431 participants. At 6months post-randomization, the proportions screened by any FOBT were 0.69 (95% confidence interval [CI] 0.66–0.72) for the OC-Auto arm, 0.64 (95% CI: 0.61–0.68) for the InSure arm, and 0.61 (95% CI: 0.58–0.65) for the Hemoccult SENSA arm (P <0.001 for any difference). Pairwise comparisons showed significant differences between the OC-Auto group and each of the other groups after correction for multiple comparisons. Conclusion: Uptake of mailed FOBT kits varies by kit type. [ABSTRACT FROM AUTHOR]