Katharine McCallister

An assessment of benefits and harms of hepatocellular carcinoma surveillance in patients with cirrhosis

Although surveillance ultrasound and alpha fetoprotein (AFP) tests have minimal direct harm, downstream harms from follow‐up tests must be weighed against surveillance benefits when determining the value of hepatocellular carcinoma (HCC) screening programs. Our studys aims were to characterize prevalence and correlates of surveillance benefits and harms in cirrhosis patients undergoing HCC surveillance. We conducted a retrospective cohort study among patients with cirrhosis followed at a safety‐net health system between July 2010 and July 2013. We recorded surveillance‐related benefits, defined as early tumor detection and curative treatment, and surveillance‐related physical harms, defined as computed tomography or magnetic resonance imaging scans, biopsies, or other procedures performed for false‐positive or indeterminate surveillance results. Sociodemographic and clinical correlates of surveillance harms were evaluated using multivariable logistic regression. We identified 680 patients with cirrhosis, of whom 78 (11.5%) developed HCC during the 3‐year study period. Of the 48 (61.5%) HCCs identified by surveillance, 43.8% were detected by ultrasound, 31.2% by AFP, and 25.0% by both surveillance tests. Surveillance‐detected patients had a higher proportion of early HCC (70.2% vs. 40.0%; P = 0.009), with no difference in tumor stage between ultrasound‐ and AFP‐detected tumors (P = 0.53). Surveillance‐related physical harms were observed in 187 (27.5%) patients, with a higher proportion of ultrasound‐related harm than AFP‐related harm (22.8% vs. 11.4%; P < 0.001). Surveillance‐related harms were associated with elevated ALT (odds ratio [OR], 1.87; 95% confidence interval [CI], 1.26‐2.76), thrombocytopenia (OR, 2.06; 95% CI, 1.26‐3.38), and hepatology subspecialty care (OR, 1.63; 95% CI, 1.09‐2.42). Conclusion: Over one fourth of patients with cirrhosis experience physical harm for false‐positive or indeterminate surveillance tests—more often related to ultrasound than AFP. Interventions are needed to reduce surveillance‐related harm to increase the value of HCC screening programs in clinical practice. (Hepatology 2017;65:1196‐1205).

Outreach invitations for FIT and colonoscopy improve colorectal cancer screening rates: A randomized controlled trial in a safety-net health system.

The effectiveness of colorectal cancer (CRC) screening is limited by underuse, particularly among underserved populations. Among a racially diverse and socioeconomically disadvantaged cohort of patients, the authors compared the effectiveness of fecal immunochemical test (FIT) outreach and colonoscopy outreach to increase screening participation rates, compared with usual visit‐based care.

Impediments and Facilitators to Physical Activity and Perceptions of Sedentary Behavior Among Urban Community Residents: The Fair Park Study

Introduction Insufficient physical activity is an established risk factor for numerous chronic diseases and for premature death. Accumulating evidence reveals that prolonged sedentary time is detrimental, independent of the protective effects of physical activity. Although studies have explored correlates of physical activity among ethnic minority populations, few have examined factors related to sedentary behavior. Therefore, we conducted a preliminary investigation into urban adults’ perceptions of sedentary behavior alongside perceived barriers and enablers to physical activity. Methods In-depth semi-structured interviews were used to evaluate perceptions of physical activity and sedentary behavior in a sample of low-income, ethnic minority adults. The framework approach guided researchers in analyzing the qualitative data. Results Participants were well aware of the positive health benefits of physical activity. However, most admitted not regularly engaging in physical activity and cited numerous barriers to activity, such as lack of time, insufficient finances, and neighborhood crime. Enablers included weight loss, the presence of social support, and the availability of safe parks conducive to exercise. In comparison, participants were primarily unfamiliar with the term “sedentary behavior” and did not perceive a relationship between sedentary behavior and health outcomes. Conclusion Our findings illustrate the need to increase the awareness of negative health implications of prolonged sedentary time while continuing to address the multiple impediments to physical activity as a way to combat chronic disease.

Effect of Colonoscopy Outreach vs Fecal Immunochemical Test Outreach on Colorectal Cancer Screening Completion: A Randomized Clinical Trial

Importance Mailed fecal immunochemical test (FIT) outreach is more effective than colonoscopy outreach for increasing 1-time colorectal cancer (CRC) screening, but long-term effectiveness may need repeat testing and timely follow-up for abnormal results. Objective Compare the effectiveness of FIT outreach and colonoscopy outreach to increase completion of the CRC screening process (screening initiation and follow-up) within 3 years. Design, Setting, and Participants Pragmatic randomized clinical trial from March 2013 to July 2016 among 5999 participants aged 50 to 64 years who were receiving primary care in Parkland Health and Hospital System and were not up to date with CRC screenings. Interventions Random assignment to mailed FIT outreach (n = 2400), mailed colonoscopy outreach (n = 2400), or usual care with clinic-based screening (n = 1199). Outreach included processes to promote repeat annual testing for individuals in the FIT outreach group with normal results and completion of diagnostic and screening colonoscopy for those with an abnormal FIT result or assigned to colonoscopy outreach. Main Outcomes and Measures Primary outcome was screening process completion, defined as adherence to colonoscopy completion, annual testing for a normal FIT result, diagnostic colonoscopy for an abnormal FIT result, or treatment evaluation if CRC was detected. Secondary outcomes included detection of any adenoma or advanced neoplasia (including CRC) and screening-related harms (including bleeding or perforation). Results All 5999 participants (median age, 56 years; women, 61.9%) were included in the intention-to-screen analyses. Screening process completion was 38.4% in the colonoscopy outreach group, 28.0% in the FIT outreach group, and 10.7% in the usual care group. Compared with the usual care group, between-group differences for completion were higher for both outreach groups (27.7% [95% CI, 25.1% to 30.4%] for the colonoscopy outreach group; 17.3% [95% CI, 14.8% to 19.8%] for FIT outreach group), and highest in the colonoscopy outreach group (10.4% [95% CI, 7.8% to 13.1%] for the colonoscopy outreach group vs FIT outreach group; P < .001 for all comparisons). Compared with usual care, the between-group differences in adenoma and advanced neoplasia detection rates were higher for both outreach groups (colonoscopy outreach group: 10.3% [95% CI, 9.5% to 12.1%] for adenoma and 3.1% [95% CI, 2.0% to 4.1%] for advanced neoplasia, P < .001 for both comparisons; FIT outreach group: 1.3% [95% CI, −0.1% to 2.8%] for adenoma and 0.7% [95% CI, −0.2% to 1.6%] for advanced neoplasia, P < .08 and P < .13, respectively), and highest in the colonoscopy outreach group (colonoscopy outreach group vs FIT outreach group: 9.0% [95% CI, 7.3% to 10.7%] for adenoma and 2.4% [95% CI, 1.3% to 3.3%] for advanced neoplasia, P < .001 for both comparisons). There were no screening-related harms in any groups. Conclusions and Relevance Among persons aged 50 to 64 years receiving primary care at a safety-net institution, mailed outreach invitations offering FIT or colonoscopy compared with usual care increased the proportion completing CRC screening process within 3 years. The rate of screening process completion was higher with colonoscopy than FIT outreach. Trial Registration clinicaltrials.gov Identifier: NCT01710215

Impact of Risk Assessment and Tailored versus Nontailored Risk Information on Colorectal Cancer Testing in Primary Care: A Randomized Controlled Trial

Background: Colorectal cancer screening is effective but underused. Guidelines for which tests are recommended and at what intervals depend on specific risks. We developed a tablet-based Cancer Risk Intake System (CRIS) that asks questions about risk prior to appointments and generates tailored printouts for patients and physicians summarizing and matching risk factors with guideline-based recommendations. Methods: Randomized controlled trial among patients who: (i) used CRIS and they and their physicians received tailored printouts; (ii) used CRIS to answer questions but received standard information about cancer screening while their physicians received a standard electronic chart prompt indicating they were age-eligible but not currently adherent for colorectal cancer screening; or (iii) comprised a no-contact group that neither used CRIS nor received any information while their physicians received the standard prompt. Participation in testing was assessed via electronic medical record at 12 months. Results: Participation in any colorectal cancer testing was three times higher for those who used the CRIS and received any printed materials, compared with no-contact controls (47% vs. 16%; P < 0.0001). Among CRIS users ages 50 and older, participation in any testing was higher in the tailored group (53% vs. 44%, P = 0.023). Conclusion: Use of CRIS and receipt of any information facilitated participation in testing. There was more testing participation in the CRIS-tailored than nontailored group. Impact: Asking patients questions about their specific risk factors and giving them and their providers information just prior to an appointment may increase participation in colorectal cancer testing. Tailoring the information has some added benefit. Cancer Epidemiol Biomarkers Prev; 24(10); 1523–30. ©2015 AACR.

Tailored information increases patient/physician discussion of colon cancer risk and testing: The Cancer Risk Intake System trial

Assess whether receipt of tailored printouts generated by the Cancer Risk Intake System (CRIS) – a touch-screen computer program that collects data from patients and generates printouts for patients and physicians – results in more reported patient-provider discussions about colorectal cancer (CRC) risk and screening than receipt of non-tailored information. Cluster-randomized trial, randomized by physician, with data collected via CRIS prior to visit and 2-week follow-up telephone survey among 623 patients. Patients aged 25–75 with upcoming primary-care visits and eligible for, but currently non-adherent to CRC screening guidelines. Patient-reported discussions with providers about CRC risk and testing. Tailored recipients were more likely to report patient-physician discussions about personal and familial risk, stool testing, and colonoscopy (all p < 0.05). Tailored recipients were more likely to report discussions of: chances of getting cancer (+ 10%); family history (+ 15%); stool testing (+ 9%); and colonoscopy (+ 8%) (all p < 0.05). CRIS is a promising strategy for facilitating discussions about testing in primary-care settings.

Identifying quality improvement targets to facilitate colorectal cancer screening completion

The colorectal cancer (CRC) screening process involves multiple interfaces (communication exchanges and transfers of responsibility for specific actions) among primary care and gastroenterology providers, laboratory, and administrative staff. After a retrospective electronic health record (EHR) analysis discovered substantial clinic variation and low CRC screening prevalence overall in an urban, integrated safety-net system, we launched a qualitative analysis to identify potential quality improvement targets to enhance fecal immunochemical test (FIT) completion, the systems preferred screening modality. Here, we report examination of organization-, clinic-, and provider-level interfaces over a three-year period (December 2011–October 2014). We deployed in parallel 3 qualitative data collection methods: (1) structured observation (90+ hours, 10 sites); (2) document analysis (n > 100); and (3) semi-structured interviews (n = 41) and conducted iterative thematic analysis in which findings from each method cross-informed subsequent data collection. Thematic analysis was guided by a conceptual model and applied deductive and inductive codes. There was substantial variation in protocols for distributing and returning FIT kits both within and across clinics. Providers, clinic and laboratory staff had differing access to important data about FIT results based on clinical information system used and this affected results reporting. Communication and coordination during electronic referrals for diagnostic colonoscopy was suboptimal particularly for co-morbid patients needing anesthesia clearance. Our multi-level approach elucidated organizational deficiencies not evident by quantitative analysis alone. Findings indicate potential quality improvement intervention targets including: (1) best-practices implementation across clinics; (2) detailed communication to providers about FIT results; and (3) creation of EHR alerts to resolve pending colonoscopy referrals before they expire.

Mailed Outreach Invitations Significantly Improve HCC Surveillance Rates in Patients with Cirrhosis: A Randomized Clinical Trial

Hepatocellular carcinoma (HCC) surveillance is associated with early tumor detection and improved survival in patients with cirrhosis; however, effectiveness is limited by underuse. We compared the effectiveness of mailed outreach and patient navigation strategies to increase HCC surveillance in a racially diverse cohort of patients with cirrhosis. We conducted a pragmatic randomized clinical trial comparing mailed outreach for screening ultrasound (n = 600), mailed outreach plus patient navigation (n = 600), or usual care with visit‐based screening (n = 600) among 1800 patients with cirrhosis at a large safety‐net health system from December 2014 to March 2017. Patients who did not respond to outreach invitations within 2 weeks received reminder telephone calls. Patient navigation included an assessment of barriers to surveillance and encouragement of surveillance participation. The primary outcome was HCC surveillance (abdominal imaging every 6 months) over an 18‐month period. All 1800 patients were included in intention‐to‐screen analyses. HCC surveillance was performed in 23.3% of outreach/navigation patients, 17.8% of outreach‐alone patients, and 7.3% of usual care patients. HCC surveillance was 16.0% (95% confidence interval [CI]: 12.0%‐20.0%) and 10.5% (95% CI: 6.8%‐14.2%) higher in outreach groups than usual care (P < 0.001 for both) and 5.5% (95% CI: 0.9%‐10.1%) higher for outreach/navigation than outreach alone (P = 0.02). Both interventions increased HCC surveillance across predefined patient subgroups. The proportion of HCC patients detected at an early stage did not differ between groups; however, a higher proportion of patients with screen‐detected HCC across groups had early‐stage tumors than those with HCC detected incidentally or symptomatically (83.3% versus 30.8%, P = 0.003). Conclusion: Mailed outreach invitations and navigation significantly increased HCC surveillance versus usual care in patients with cirrhosis.

Recommendation of colorectal cancer testing among primary care patients younger than 50 with elevated risk

In the era of precision medicine, efforts are needed to identify and tailor screening recommendations among elevated-risk patients. Individuals younger than 50years are an important target population, as they comprise 15% of colorectal (CRC) cases and often present with more advanced disease than their 50+ counterparts. In this large study, 2470 patients ages 25-49 used a tablet-based program that assessed risks, matched risks with screening guidelines, and generated tailored printed guideline-concordant recommendations for patients and their providers. The tablet-based program identified 121 (4.9%) patients with risk factors warranting screening before age 50. Likelihood of risk warranting screening was greater for ages 40-49 than <40years (OR: 2.38), females than males (OR: 1.82), and African Americans (OR: 1.69) and non-Hispanic Whites (OR: 2.89) compared to Hispanics. Most common risk factors were family history of polyps (23.1%), personal history of inflammatory bowel disease (19.8%), and combined family history of CRC+polyps (18.2%). Receipt of guideline-concordant screening within 6months of identification was low, including only 5.3% of those who needed colonoscopy and 13.3% for whom colonoscopy or FIT was recommended. Although elevated-risk patients younger than 50years can be readily identified, more than notification is necessary to facilitate screening participation.