Blood Test Increases Colorectal Cancer Screening in Persons Who Declined Colonoscopy and Fecal Immunochemical Test: A Randomized Controlled Trial.

BACKGROUND & AIMS: The septin 9 blood test is indicated for colorectal cancer screening in individuals who decline first-line tests, but participation in this context is unclear. We conducted a randomized controlled trial to compare reoffering colonoscopy and fecal immunochemical test (FIT) alone versus also offering the blood test among individuals who declined colonoscopy and FIT. METHODS: Screen-eligible Veterans aged 50-75 years who declined colonoscopy and FIT within the previous 6 months were randomized to letter and telephone outreach to reoffer screening with colonoscopy/FIT only (control), or additionally offering the blood test as a second-line option (intervention). The primary outcome was completion of any screening test within 6 months. The secondary outcome was completion of a full screening strategy within 6 months, including colonoscopy for those with a positive noninvasive test. RESULTS: Of 359 participants who completed follow-up, 9.6% in the control group and 17.1% in the intervention group completed any screening (7.5% difference; P = .035). Uptake of colonoscopy and FIT was similar in the 2 groups. The full screening strategy was completed in 9.0% and 14.9% in the control and intervention groups, respectively (5.9% difference; P = .084). CONCLUSIONS: Among individuals who previously declined colonoscopy and FIT, offering a blood test as a secondary option increased screening by 7.5% without decreasing uptake of first-line screening options. However, completion of a full screening strategy did not increase. These findings indicate that a blood test is a promising method to improve colorectal cancer screening, but obtaining a timely colonoscopy after a positive noninvasive test remains a challenge (ClincialTrials.gov number, NCT03598166).

Protocol: A multi-modal, physician-centered intervention to improve guideline-concordant prostate cancer imaging.

BACKGROUND: Almost half of Veterans with localized prostate cancer receive inappropriate, wasteful staging imaging. Our team has explored the barriers and facilitators of guideline-concordant prostate cancer imaging and found that (1) patients with newly diagnosed prostate cancer have little concern for radiographic staging but rather focus on treatment and (2) physicians trust imaging guidelines but are apt to follow their own intuition, fear medico-legal consequences, and succumb to influence from imaging-avid colleagues. We used a theory-based approach to design a multi-level intervention strategy to promote guideline-concordant imaging to stage incident prostate cancer. METHODS: We designed the Prostate Cancer Imaging Stewardship (PCIS) intervention: a multi-site, stepped wedge, cluster-randomized trial to determine the effect of a physician-focused behavioral intervention on Veterans Health Administration (VHA) prostate cancer imaging use. The multi-level intervention, developed according to the Theoretical Domains Framework (TDF) and Behavior Change Wheel, combines traditional physician behavior change methods with novel methods of communication and data collection. The intervention consists of three components: (1) a system of audit and feedback to clinicians informing individual clinicians and their sites about how their behavior compares to their peers' and to published guidelines, (2) a program of academic detailing with the goal to educate providers about prostate cancer imaging, and (3) a CPRS Clinical Order Check for potentially guideline-discordant imaging orders. The intervention will be introduced to 10 participating geographically distributed study sites. DISCUSSION: This study is a significant contribution to implementation science, providing VHA an opportunity to ensure delivery of high-quality care at the lowest cost using a theory-based approach. The study is ongoing. Preliminary data collection and recruitment have started; analysis has yet to be performed. TRIAL REGISTRATION: CliniclTrials.gov NCT03445559. Prospectively registered on February 26, 2018.

A Clinical Reminder Order Check Intervention to Improve Guideline-concordant Imaging Practices for Men With Prostate Cancer: A Pilot Study.

OBJECTIVE: To understand how to potentially improve inappropriate prostate cancer imaging rates we used National Comprehensive Cancer Network's guidelines to design and implement a Clinical Reminder Order Check (CROC) that alerts ordering providers of potentially inappropriate imaging orders in real-time based on patient features of men diagnosed with low-risk prostate cancer. METHODS: We implemented the CROC at VA New York Harbor Healthcare System from April 2, 2015 to November 15, 2017. We then used VA administrative claims from the VA's Corporate Data Warehouse to analyze imaging rates among men with low-risk prostate cancer at VA New York Harbor Healthcare System before and after CROC implementation. We also collected and cataloged provider responses in response to overriding the CROC in qualitative analysis. RESULTS FIFTY SEVEN PERCENT: (117/205) of Veterans before CROC installation and 73% (61/83) of Veterans post-intervention with low-risk prostate cancer received guideline-concordant care. CONCLUSION: While the decrease in inappropriate imaging during our study window was almost certainly due to many factors, a Computerized Patient Record System-based CROC intervention is likely associated with at least moderate improvement in guideline-concordant imaging practices for Veterans with low-risk prostate cancer.

Colchicine Use and Incident Coronary Artery Disease in Male Patients With Gout.

BACKGROUND: Inflammation is associated with coronary artery disease (CAD) and myocardial infarction (MI). Patients with gout are at increased risk of MI, and colchicine is associated with a reduced risk of MI. The objective of this study was to determine whether colchicine prevents incident development of CAD in patients with gout. METHODS: This retrospective study followed a cohort of male patients with gout without known CAD at the time of diagnosis of gout in the VA New York Harbor Healthcare System. The association between colchicine use and development of incident CAD, defined as evidence of ischemia or obstructive CAD on stress test or angiography, was determined using an inverse probability weighted (IPW) Cox proportional hazard model. RESULTS: Among 178,877 patients, 1638 met criteria of gout, of whom 722 without known CAD at baseline (446 colchicine users and 276 nonusers) were followed for a median of 96 months (57 to 117). A trend toward association between use of colchicine and reduced incident CAD was observed but not statistically significant (IPW hazard ratio [HR], 0.49; 0.23-1.05). In patients without chronic kidney disease, use of colchicine was associated with a lower rate of incident CAD (interaction P = 0.005, IPW HR, 0.31; 0.14-0.70). Colchicine was also associated with a lower rate of the composite of incident CAD and MI (IPW HR, 0.37; 0.16-0.83). CONCLUSIONS: In male patients with gout and no known CAD, a trend of reduced incident CAD was observed with use of colchicine that was not statistically significant. Larger, prospective studies will be required to assess the primary prevention benefit of colchicine definitively.

Gout and Progression of Aortic Stenosis.

BACKGROUND: Patients with aortic stenosis are nearly twice as likely to have a diagnosis of gout compared with individuals without aortic valve disease. METHODS: This retrospective study evaluated consecutive adults age ≥65 years with aortic stenosis between December 2012 and November 2016 who underwent at least 2 transthoracic echocardiograms (TTEs) separated by at least 1 year. Severe aortic stenosis was defined as any combination of an aortic valve peak velocity ≥4.0 m/sec, mean gradient ≥40 mm Hg, aortic valve area ≤1 cm2, or decrease in left ventricular ejection fraction as a result of aortic stenosis. RESULTS: Of the 699 study patients, gout was present in 73 patients (10%) and not found in 626 patients (90%). Median follow-up was 903 days [552-1302] for patients with gout and 915 days [601-1303] for patients without gout (P = 0.60). The presence of severe aortic stenosis on follow-up transthoracic echocardiogram was more frequent in patients with gout compared to those without gout (74% vs 54%, P = 0.001; hazard ratio [HR] 1.45 [1.09-1.93]), even among the 502 patients without severe aortic stenosis at baseline (63% vs 39%, P = 0.003; hazard ratio 1.43 [1.07-1.91]). Gout remained associated with the development of severe aortic stenosis after multivariable adjustment (adjusted hazard ratio [aHR] 1.46 [1.03-2.08], P = 0.03). The annualized reduction in aortic valve area was numerically greater in the group with gout compared with the group without gout (-0.10 cm2/y [-0.18, -0.03] vs -0.08 cm2/y [-0.16, -0.01], P = 0.09); annualized change in peak velocity and mean gradient did not differ between groups. CONCLUSIONS: Progression to severe aortic stenosis was more frequent in patients with gout compared with those without gout, supporting the hypothesis that gout is a risk factor for aortic stenosis.

Association of tattooing and hepatitis C virus infection: a multicenter case-control study.

UNLABELLED: Although injection drug use (IDU) and blood transfusions prior to 1992 are well-accepted risk factors for hepatitis C virus (HCV) infection, many studies that evaluated tattooing as a risk factor for HCV infection did not control for a history of IDU or transfusion prior to 1992. In this large, multicenter, case-control study, we analyzed demographic and HCV risk factor exposure history data from 3,871 patients, including 1,930 with chronic HCV infection (HCV RNA-positive) and 1,941 HCV-negative (HCV antibody-negative) controls. Crude and fully adjusted odds ratios (ORs) of tattoo exposure by multivariate logistic regression in HCV-infected versus controls were determined. As expected, IDU (65.9% versus 17.8%; P < 0.001), blood transfusion prior to 1992 (22.3% versus 11.1%; P < 0.001), and history of having one or more tattoos (OR, 3.81; 95% CI, 3.23-4.49; P < 0.001) were more common in HCV-infected patients than in control subjects. After excluding all patients with a history of ever injecting drugs and those who had a blood transfusion prior to 1992, a total of 1,886 subjects remained for analysis (465 HCV-positive patients and 1,421 controls). Among these individuals without traditional risk factors, HCV-positive patients remained significantly more likely to have a history of one or more tattoos after adjustment for age, sex, and race/ethnicity (OR, 5.17; 95% CI, 3.75-7.11; P < 0.001). CONCLUSION: Tattooing is associated with HCV infection, even among those without traditional HCV risk factors such as IDU and blood transfusion prior to 1992.

Sexual dysfunction is highly prevalent among men with chronic hepatitis C virus infection and negatively impacts health-related quality of life.

OBJECTIVES: Although sexual dysfunction has been reported in patients with hepatitis C virus (HCV) infection, little is known about this association. The aims of this study were to determine the prevalence of sexual dysfunction among men with chronic HCV infection and to evaluate the impact of sexual dysfunction on health-related quality of life (HRQOL). METHODS: We prospectively enrolled 112 HCV positive men and 239 HCV negative controls, and all patients completed validated questionnaires to assess sexual function (Brief Male Sexual Function Inventory [BMSFI]), depression (Beck Depression Inventory), and HRQOL (Medical Outcomes Study Short Form-36). The BMSFI assessed sexual drive, erection, ejaculation, sexual problem assessment, and overall sexual satisfaction. RESULTS: HCV positive men had significantly more sexual dysfunction than control subjects across all five domains of the BMFSI. In addition, HCV-infected men were significantly more likely than controls to not be sexually satisfied (53.6% vs 28.9%, p<0.001) and this remained statistically significant after adjusting for age, race, and other potential confounding variables (OR=3.36; 95% CI, 1.59-7.13). In the 241 individuals without depression, HCV positive men were significantly more likely to not be sexually satisfied as compared with control subjects (47.5% vs 11.0%, p<0.001). HCV-infected men who were not sexually satisfied scored significantly worse in six of eight domains of HRQOL as compared with HCV-infected men who were sexually satisfied. CONCLUSIONS: Sexual dysfunction is highly prevalent in men with chronic HCV infection, is independent of depression, and is associated with a marked reduction in HRQOL.

Colorectal cancer screening in HIV-infected patients 50 years of age and older: missed opportunities for prevention.

OBJECTIVES: Although human immunodeficiency virus (HIV)-infected patients are now living longer, there are no published data on colorectal cancer (CRC) screening in this population. We hypothesized that HIV-infected patients were less likely to be screened for CRC compared to patients without HIV. METHODS: Consecutive HIV-infected patients > or =50 yr old seen in our outpatient clinic from 1/1/01 to 6/30/02 were identified. For each HIV-infected patient, we selected one age- and gender-matched control subject without HIV infection who was seen during the same time period. The electronic medical records were reviewed to determine the proportion of patients that had a fecal occult blood test (FOBT), flexible sigmoidoscopy, air-contrast barium enema (ACBE), or colonoscopy. RESULTS: During the 18-month study period, 538 HIV-infected outpatients were seen and 302 (56.1%) were > or =50 yr old. Despite significantly more visits with their primary care provider, HIV-infected patients were less likely to have ever had at least one CRC screening test (55.6%vs 77.8%, p < 0.001). The proportion of HIV-infected patients who ever had a FOBT (43.0%vs 66.6%, p < 0.001), flexible sigmoidoscopy (5.3%vs 17.5%, p < 0.001), ACBE (2.6%vs 7.9%, p= 0.004), or colonoscopy (17.2%vs 27.5%, p= 0.002) was significantly lower than in control subjects. In addition, HIV-infected patients were significantly less likely to be up-to-date with at least one CRC screening test according to current guidelines (49.3%vs 65.6%, p < 0.001). CONCLUSIONS: A substantial number of HIV-infected patients are > or =50 yr of age and CRC screening is underutilized in this population. Public health strategies to improve CRC screening in HIV-infected patients are needed.

Randomized controlled trial of the impact of intensive patient education on compliance with fecal occult blood testing.

BACKGROUND: Randomized controlled trials have demonstrated that fecal occult blood testing (FOBT) reduces colorectal cancer (CRC) mortality. However, patient compliance with FOBT is low and this is one of the major barriers to CRC screening. OBJECTIVE: To determine whether intensive patient education increases FOBT card return rates. DESIGN: Randomized controlled trial. SETTING: Department of Veterans Affairs primary care clinic. PARTICIPANTS: Seven hundred eighty-eight patients who were referred for FOBT. INTERVENTIONS: Patients were randomly allocated to receive either intensive (n=396) or standard (n=392) patient education. Patients in the intensive education group received a one-on-one educational session by primary care nurses on the importance of CRC screening, were instructed on how to properly collect stool specimens for FOBT, and were given a 2-page handout on CRC screening. Patients in the standard education group only received the FOBT cards and written instructions from the manufacturer on how to properly collect stool specimens for FOBT. RESULTS: Patients in the intensive education group were more likely to return the FOBT cards (65.9% vs 51.3%; P<.001) and called the clinic with additional questions less often (1.5% vs 5.9%; P=.001) than the standard education group. The median time to return the FOBT cards was significantly shorter in the intensive education group (36 vs 143 days; P<.001 by log-rank test). However, the proportion of patients who had a positive FOBT did not differ in the two groups (4.6% vs 6.0%; P=.51). CONCLUSIONS: Intensive patient education significantly improved patient compliance with FOBT. Future studies to evaluate additional educational strategies to further improve patient compliance with CRC screening are warranted.