Institutional Variation in Quality of Cardiovascular Implantable Electronic Device Implantation: A Cohort Study: Annals of Internal Medicine: Vol 171, No 5

Background: Cardiovascular implantable electronic devices (CIEDs) are associated with procedure-related complications, yet little is known about variation in complication rates among institutions that may suggest disparities in care quality. Objective: To assess institutional variation in risk-standardized complication rates (RSCRs) for CIED. Design: Cohort study. Setting: 174 hospitals in Australia and New Zealand, 98 of which implanted at least 25 CIEDs during the study period. Participants: 81 304 patients older than 18 years (mean, 74.7 years [SD, 12.4]; 37.9% female) who received a new CIED (65 711 permanent pacemakers [PPMs] and 15 593 implantable cardioverter-defibrillators [ICDs]) in 2010 to 2015. Measurements: RSCRs and frequencies of major device-related complications during hospitalization or within 90 days of discharge. Results: Of the cohort, 6664 patients (8.2%) had a major complication. Although complication rates were higher for ICDs than PPMs (10.04% vs. 7.76%), 76.5% of all complications were attributable to PPMs (5098 vs. 1566 for ICDs). Among hospitals that implanted at least 25 CIEDs, the median RSCR was 8.1%; however, rates varied from 5.3% to 14.3%, with 22 hospitals identified as having RSCRs that differed significantly from the national average. Similar variation was observed when RSCRs for PPM implantation (n = 96 hospitals) (median RSCR, 7.6% [range, 5.4% to 12.9%]) were considered separately from those for ICD placement (n = 68 hospitals) (median RSCR, 9.7% [range, 6.2% to 16.9%]) and persisted when only elective procedures were assessed (n = 88 hospitals) (median RSCR, 7.4% [range, 4.7% to 13.0%]). Limitation: Possible unmeasured confounding from the use of administrative data. Conclusion: CIED complications are common and vary among hospitals, suggesting institutional variation in CIED care quality. Concerted clinical and policy interventions are needed to address CIED-related complications. These efforts should preferentially target PPMs, because most CIED complications are attributable to these devices. Primary Funding Source: The Hospitals Contribution Fund Research Foundation.

Lipophilic Statins and Risk for Hepatocellular Carcinoma and Death in Patients With Chronic Viral Hepatitis: Results From a Nationwide Swedish Population

Background: Whether statin type influences hepatocellular carcinoma (HCC) incidence or mortality in chronic hepatitis B or C virus infection is unknown. Objective: To assess the relationship between lipophilic or hydrophilic statin use and HCC incidence and mortality in a nationwide population with viral hepatitis. Design: Prospective propensity score (PS)–matched cohort. Setting: Swedish registers, 2005 to 2013. Participants: A PS-matched cohort of 16 668 adults (8334 who initiated statin use [6554 lipophilic and 1780 hydrophilic] and 8334 nonusers) among 63 279 eligible adults. Measurements: Time to incident HCC, ascertained from validated registers. Statin use was defined from filled prescriptions as 30 or more cumulative defined daily doses (cDDDs). Results: Compared with matched nonusers, 10-year HCC risk was significantly lower among lipophilic statin users (8.1% vs. 3.3%; absolute risk difference [RD], −4.8 percentage points [95% CI, −6.2 to −3.3 percentage points]; adjusted subdistribution hazard ratio [aHR], 0.56 [CI, 0.41 to 0.79]) but not hydrophilic statin users (8.0% vs. 6.8%; RD, −1.2 percentage points [CI, −2.6 to 0.4 percentage points]; aHR, 0.95 [CI, 0.86 to 1.08]). The inverse association between lipophilic statins and HCC risk seemed to be dose-dependent. Compared with nonusers, 10-year HCC risk was lowest with 600 or more lipophilic statin cDDDs (8.4% vs. 2.5%; RD, −5.9 percentage points [CI, −7.6 to −4.2 percentage points]; aHR, 0.41 [CI, 0.32 to 0.61]), and 10-year mortality was significantly lower among both lipophilic (15.2% vs. 7.3%; RD, −7.9 percentage points [CI, −9.6 to −6.2 percentage points]) and hydrophilic (16.0% vs. 11.5%; RD, −4.5 percentage points [CI, −6.0 to −3.0 percentage points]) statin users. Limitation: Lack of lipid, fibrosis, or HCC surveillance data. Conclusion: In a nationwide viral hepatitis cohort, lipophilic statins were associated with significantly reduced HCC incidence and mortality. An association between hydrophilic statins and reduced risk for HCC was not found. Further research is needed to determine whether lipophilic statin therapy is feasible for prevention of HCC. Primary Funding Source: None.

In Screening for Colorectal Cancer, Is the FIT Right for the Right Side of the Colon?

Private Equity Acquisition of Physician Practices

A Cost-Effectiveness Analysis of Vaccination for Prevention of Herpes Zoster and Related Complications: Input for National Recommendations

Background: The U.S. Advisory Committee on Immunization Practices recently developed recommendations for use of a new recombinant zoster vaccine (RZV). Objective: To evaluate the cost-effectiveness of vaccination with RZV compared with zoster vaccine live (ZVL) and no vaccination, the cost-effectiveness of vaccination with RZV for persons who have previously received ZVL, and the cost-effectiveness of preferential vaccination with RZV over ZVL. Design: Simulation (state-transition) model using U.S. epidemiologic, clinical, and cost data. Data Sources: Published data. Target Population: Hypothetical cohort of immunocompetent U.S. adults aged 50 years or older. Time Horizon: Lifetime. Perspective: Societal and health care sector. Intervention: Vaccination with RZV (recommended 2-dose regimen), vaccination with ZVL, and no vaccination. Outcome Measures: The primary outcome measure was the incremental cost-effectiveness ratio (ICER). Results of Base-Case Analysis: For vaccination with RZV compared with no vaccination, ICERs ranged by age from $10 000 to $47 000 per quality-adjusted life-year (QALY), using a societal perspective and assuming 100% completion of the 2-dose RZV regimen. For persons aged 60 years or older, ICERs were less than $60 000 per QALY. Vaccination with ZVL was dominated by vaccination with RZV for all age groups 60 years or older. Results of Sensitivity Analysis: Results were most sensitive to changes in vaccine effectiveness, duration of protection, herpes zoster incidence, and probability of postherpetic neuralgia. Vaccination with RZV after previous administration of ZVL yielded an ICER of less than $60 000 per QALY for persons aged 60 years or older. In probabilistic sensitivity analyses, RZV remained the preferred strategy in at least 95% of simulations, including those with 50% completion of the second dose. Limitation: Few data were available on risk for serious adverse events, adherence to the recommended 2-dose regimen, and probability of recurrent zoster. Conclusion: Vaccination with RZV yields cost-effectiveness ratios lower than those for many recommended adult vaccines, including ZVL. Results are robust over a wide range of plausible values. Primary Funding Source: Centers for Disease Control and Prevention.

U.S. Internists' Perspectives on Discussing Cost of Care With Patients: Structured Interviews and a Survey

Background: Rising out-of-pocket costs are creating a need for cost conversations between patients and physicians. Objective: To understand the factors that influence physicians to discuss and consider cost during a patient encounter. Design: Mixed-methods study using semistructured interviews and a survey. Setting: United States. Participants: 20 internal medicine physicians were interviewed; 621 internal medicine physician members of the American College of Physicians completed the survey. Measurements: Interviews were analyzed by using thematic analysis, and surveys were analyzed by using descriptive statistics. Results: From the interviews, 4 themes were identified: Physicians are 1) aware that patients are struggling to afford medical care; 2) relying on clues from patients that hint at their cost sensitivity; 3) relying on experience to anticipate potentially high-cost treatments; and 4) aware that patients are making financial trade-offs to afford their care. Three quarters (n = 466) of survey respondents stated that they consider out-of-pocket costs when making most clinical decisions. For 31% (n = 191) of participants, there were times in the past year that they wanted to discuss out-of-pocket prescription drug costs with patients but did not. The most influential factors for ordering a test are the desire to be as thorough as possible (71% [n = 422]) and insurance coverage for the test (68% [n = 422]). Limitation: Findings are self-reported, the sample is limited to a single specialty, the survey response rate was low, information on the patient population was limited, and the survey instrument is not validated. Conclusion: Physicians are attuned to the burden of health care costs and are willing to consider alternative options based on a patient's cost sensitivity. Primary Funding Source: Robert Wood Johnson Foundation.

Making Colonoscopy Smarter With Standardized Computer-Aided Diagnosis

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New Insights Into Optimal Timing of Hepatitis C Virus Treatment for Dialysis Patients Waitlisted for Kidney Transplant

Intensive Models of Hepatitis C Care for People Who Inject Drugs Receiving Opioid Agonist Therapy: A Randomized Controlled Trial: Annals of Internal Medicine: Vol 170, No 9

Background: Many people who inject drugs (PWID) are denied treatment for hepatitis C virus (HCV) infection, even if they are receiving opioid agonist therapy (OAT). Research suggests that HCV in PWID may be treated effectively, but optimal models of care for promoting adherence and sustained virologic response (SVR) have not been evaluated in the direct-acting antiviral (DAA) era. Objective: To determine whether directly observed therapy (DOT) and group treatment (GT) are more effective than self-administered individual treatment (SIT) in promoting adherence and achieving SVR among PWID receiving OAT. Design: Three-group, randomized controlled trial conducted from October 2013 to April 2017. (ClinicalTrials.gov: NCT01857245) Setting: Three OAT programs in Bronx, New York. Participants: Persons aged 18 years and older with genotype 1 HCV infection who were willing to receive HCV therapy on site in the OAT program. Of 190 persons screened, 158 were randomly assigned to a study group and 150 initiated treatment: DOT (n = 51), GT (n = 48), and SIT (n = 51). Intervention: 2 intensive interventions (DOT and GT) and 1 control condition (SIT). Measurements: Primary: adherence, measured by using electronic blister packs. Secondary: HCV treatment completion and SVR 12 weeks after treatment completion. Results: Mean age was 51 years; 65% of participants had positive results on urine drug testing during the 6 months before treatment, and 75% reported ever injecting drugs. Overall adherence, estimated from mixed-effects models using the daily timeframe, was 78% (95% CI, 75% to 81%) and was greater among participants randomly assigned to DOT (86% [CI, 80% to 92%]) than those assigned to SIT (75% [CI, 70% to 81%]; difference, 11% [CI, 5% to 18%]; Bonferroni-corrected P = 0.001). No significant difference in adherence was observed between participants randomly assigned to GT (80% [CI, 74% to 86%]) and those assigned to SIT (difference, 4.7% [CI, −2% to 11%]; Bonferroni-corrected P = 0.29). The HCV treatment completion rate was 97%, with no differences among groups (P = 0.53). Overall SVR was 94% (CI, 89% to 97%); the SVR rate was 98% in the DOT group, 94% in the GT group, and 90% in the SIT group (P = 0.152). Limitation: These findings may not be generalizable to PWID not enrolled in OAT programs. Conclusion: All models of onsite HCV care delivered to PWID in OAT programs resulted in high SVR, despite ongoing drug use. Directly observed therapy was associated with greater adherence than SIT. Primary Funding Source: National Institute on Drug Abuse and Gilead Sciences.