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Facilitating Shared Decision Making Among Black Patients at Risk for Sudden Cardiac Arrest: A Randomized Clinical Trial: Annals of Internal Medicine: Vol 176, No 5
Background: Racial disparities in implantable cardioverter-defibrillator (ICD) implantation are multifactorial and are partly explained by higher refusal rates. Objective: To assess the effectiveness of a video decision support tool for Black patients eligible for an ICD. Design: Multicenter, randomized clinical trial conducted between September 2016 and April 2020. (ClinicalTrials.gov: NCT02819973) Setting: Fourteen academic and community-based electrophysiology clinics in the United States. Participants: Black adults with heart failure who were eligible for a primary prevention ICD. Intervention: An encounter-based video decision support tool or usual care. Measurements: The primary outcome was the decision regarding ICD implantation. Additional outcomes included patient knowledge, decisional conflict, ICD implantation within 90 days, the effect of racial concordance on outcomes, and the time patients spent with clinicians. Results: Of the 330 randomly assigned patients, 311 contributed data for the primary outcome. Among those randomly assigned to the video group, assent to ICD implantation was 58.6% compared with 59.4% in the usual care group (difference, −0.8 percentage point [95% CI, −13.2 to 11.1 percentage points]). Compared with usual care, participants in the video group had a higher mean knowledge score (difference, 0.7 [CI, 0.2 to 1.1]) and a similar decisional conflict score (difference, −2.6 [CI, −5.7 to 0.4]). The ICD implantation rate within 90 days was 65.7%, with no differences by intervention. Participants randomly assigned to the video group spent less time with their clinician than those in the usual care group (mean, 22.1 vs. 27.0 minutes; difference, −4.9 minutes [CI, −9.4 to −0.3 minutes]). Racial concordance between video and study participants did not affect study outcomes. Limitation: The Centers for Medicare & Medicaid Services implemented a requirement for shared decision making for ICD implantation during the study. Conclusion: A video-based decision support tool increased patient knowledge but did not increase assent to ICD implantation. Primary Funding Source: Patient-Centered Outcomes Research Institute.
Second-Line Chimeric Antigen Receptor T-Cell Therapy in Diffuse Large B-Cell Lymphoma: A Cost-Effectiveness Analysis: Annals of Internal Medicine: Vol 176, No 12
Background: First-line treatment of diffuse large B-cell lymphoma (DLBCL) achieves durable remission in approximately 60% of patients. In relapsed or refractory disease, only about 20% achieve durable remission with salvage chemoimmunotherapy and consolidative autologous stem cell transplantation (ASCT). The ZUMA-7 (axicabtagene ciloleucel [axi-cel]) and TRANSFORM (lisocabtagene maraleucel [liso-cel]) trials demonstrated superior event-free survival (and, in ZUMA-7, overall survival) in primary-refractory or early-relapsed (high-risk) DLBCL with chimeric antigen receptor T-cell therapy (CAR-T) compared with salvage chemoimmunotherapy and consolidative ASCT; however, list prices for CAR-T exceed $400 000 per infusion. Objective: To determine the cost-effectiveness of second-line CAR-T versus salvage chemoimmunotherapy and consolidative ASCT. Design: State-transition microsimulation model. Data Sources: ZUMA-7, TRANSFORM, other trials, and observational data. Target Population: “High-risk” patients with DLBCL. Time Horizon: Lifetime. Perspective: Health care sector. Intervention: Axi-cel or liso-cel versus ASCT. Outcome Measures: Incremental cost-effectiveness ratio (ICER) and incremental net monetary benefit (iNMB) in 2022 U.S. dollars per quality-adjusted life-year (QALY) for a willingness-to-pay (WTP) threshold of $200 000 per QALY. Results of Base-Case Analysis: The increase in median overall survival was 4 months for axi-cel and 1 month for liso-cel. For axi-cel, the ICER was $684 225 per QALY and the iNMB was −$107 642. For liso-cel, the ICER was $1 171 909 per QALY and the iNMB was −$102 477. Results of Sensitivity Analysis: To be cost-effective with a WTP of $200 000, the cost of CAR-T would have to be reduced to $321 123 for axi-cel and $313 730 for liso-cel. Implementation in high-risk patients would increase U.S. health care spending by approximately $6.8 billion over a 5-year period. Limitation: Differences in preinfusion bridging therapies precluded cross-trial comparisons. Conclusion: Neither second-line axi-cel nor liso-cel was cost-effective at a WTP of $200 000 per QALY. Clinical outcomes improved incrementally, but costs of CAR-T must be lowered substantially to enable cost-effectiveness. Primary Funding Source: No research-specific funding.
Effectiveness of an Intervention to Improve Decision Making for Older Patients With Advanced Chronic Kidney Disease: A Randomized Controlled Trial: Annals of Internal Medicine: Vol 176, No 1
Background: Older patients with advanced chronic kidney disease (CKD) face difficult decisions about managing kidney failure, frequently experiencing decisional conflict, regret, and treatment misaligned with preferences. Objective: To assess whether a decision aid about kidney replacement therapy improved decisional quality compared with usual care. Design: Multicenter, randomized, controlled trial. (ClinicalTrials.gov: NCT03522740) Setting: 8 outpatient nephrology clinics associated with 4 U.S. centers. Participants: English-fluent patients, 70 years and older with nondialysis CKD stages 4 to 5 recruited from 2018 to 2020. Intervention: DART (Decision-Aid for Renal Therapy) is an interactive, web-based decision aid for older adults with CKD. Both groups received written education about treatments. Measurements: Change in the decisional conflict scale (DCS) score from baseline to 3, 6, 12, and 18 months. Secondary outcomes included change in prognostic and treatment knowledge and change in uncertainty. Results: Among 400 participants, 363 were randomly assigned: 180 to usual care, 183 to DART. Decisional quality improved with DART with mean DCS declining compared with control (mean difference, −8.5 [95% CI, −12.0 to −5.0]; P < 0.001), with similar findings at 6 months, attenuating thereafter. At 3 months, knowledge improved with DART versus usual care (mean difference, 7.2 [CI, 3.7 to 10.7]; P < 0.001); similar findings at 6 months were modestly attenuated at 18 months (mean difference, 5.9 [CI, 1.4 to 10.3]; P = 0.010). Treatment preferences changed from 58% “unsure” at baseline to 28%, 20%, 23%, and 14% at 3, 6, 12, and 18 months, respectively, with DART, versus 51% to 38%, 35%, 32%, and 18% with usual care. Limitation: Latinx patients were underrepresented. Conclusion: DART improved decision quality and clarified treatment preferences among older adults with advanced CKD for 6 months after the DART intervention. Primary Funding Source: Patient-Centered Outcomes Research Institute (PCORI).
Assessing Heterogeneity of Treatment Effect in Real-World Data
Increasing availability of real-world data (RWD) generated from patient care enables the generation of evidence to inform clinical decisions for subpopulations of patients and perhaps even individuals. There is growing opportunity to identify important heterogeneity of treatment effects (HTE) in these subgroups. Thus, HTE is relevant to all with interest in patients' responses to interventions, including regulators who must make decisions about products when signals of harms arise postapproval and payers who make coverage decisions based on expected net benefit to their beneficiaries. Prior work discussed HTE in randomized studies. Here, we address methodological considerations when investigating HTE in observational studies. We propose 4 primary goals of HTE analyses and the corresponding approaches in the context of RWD: to confirm subgroup effects, to describe the magnitude of HTE, to discover clinically important subgroups, and to predict individual effects. We discuss other possible goals including exploring prognostic score– and propensity score–based treatment effects, and testing the transportability of trial results to populations different from trial participants. Finally, we outline methodological needs for enhancing real-world HTE analysis.
Monoclonal Antibodies for Treatment of SARS-CoV-2 Infection During Pregnancy: A Cohort Study: Annals of Internal Medicine: Vol 175, No 12
Background: Monoclonal antibody (mAb) treatment decreases hospitalization and death in high-risk outpatients with mild to moderate COVID-19. However, no studies have evaluated adverse events and effectiveness of mAbs in pregnant persons compared with no mAb treatment. Objective: To determine the frequency of drug-related adverse events and obstetric-associated safety outcomes after treatment with mAb compared with no mAb treatment of pregnant persons, and the association between mAb treatment and a composite of 28-day COVID-19–related hospital admission or emergency department (ED) visit, COVID-19–associated delivery, or mortality. Design: Retrospective, propensity score–matched, cohort study. Setting: UPMC Health System from 30 April 2021 to 21 January 2022. Participants: Persons aged 12 years or older with a pregnancy episode and any documented positive SARS-CoV-2 test (polymerase chain reaction or antigen test). Intervention: Bamlanivimab and etesevimab, casirivimab and imdevimab, or sotrovimab treatment compared with no mAb treatment. Measurements: Drug-related adverse events, obstetric-associated safety outcomes among persons who delivered, and a risk-adjusted composite of 28-day COVID-19–related hospital admission or ED visit, COVID-19–associated delivery, or mortality. Results: Among 944 pregnant persons (median age [interquartile range (IQR)], 30 years [26 to 33 years]; White (79.5%; n = 750); median Charlson Comorbidity Index score [IQR], 0 [0 to 0]), 552 received mAb treatment (58%). Median gestational age at COVID-19 diagnosis or treatment was 179 days (IQR, 123 to 227), and most persons received sotrovimab (69%; n = 382). Of those with known vaccination status, 392 (62%) were fully vaccinated. Drug-related adverse events were uncommon (n = 8; 1.4%), and there were no differences in any obstetric-associated outcome among 778 persons who delivered. In the total population, the risk ratio for mAb treatment of the composite 28-day COVID-19–associated outcome was 0.71 (95% CI, 0.37 to 1.4). The propensity score–matched risk ratio was 0.61 (95% CI, 0.34 to 1.1). There were no deaths among mAb-treated patients compared with 1 death in the nontreated control patients. There were more non-COVID-19–related hospital admissions in the mAb-treated persons in the unmatched cohort (14 [2.5%] vs. 2 [0.5%]; risk ratio, 5.0; 95% CI, 1.1 to 21.7); however, there was no difference in the propensity score–matched rates, which were 2.5% mAb-treated vs. 2% untreated (risk ratio, 1.3; 95% CI, 0.58% to 2.8%). Limitations: Drug-related adverse events were patient and provider reported and potentially underrepresented. Symptom severity at the time of SARS-CoV-2 testing was not available for nontreated patients. Conclusion: In pregnant persons with mild to moderate COVID-19, adverse events after mAb treatment were mild and rare. There was no difference in obstetric-associated safety outcomes between mAb treatment and no treatment among persons who delivered. There was no difference in 28-day COVID-19–associated outcomes and non-COVID-19–related hospital admissions for mAb treatment compared with no mAb treatment in a propensity score–matched cohort. Primary Funding Source: No funding was received for this study.
Anticoagulant Therapy for Cancer-Associated Thrombosis: A Cost-Effectiveness Analysis: Annals of Internal Medicine: Vol 176, No 1
Background: Direct oral anticoagulants (DOACs) offer an alternative to low-molecular-weight heparin (LMWH) and warfarin for treating cancer-associated thrombosis (CAT). Objective: To determine the cost and effectiveness of DOACs versus LMWH. Design: Cohort-state transition decision analytic model. Data Sources: Network meta-analysis comparing DOACs versus LMWH. Target Population: Adult patients with cancer at the time they develop thrombosis. Time Horizon: Lifetime. Perspective: Health care sector. Intervention: Strategies of 1) enoxaparin, 2) apixaban, 3) edoxaban, and 4) rivaroxaban for treatment of CAT. Outcome Measures: Incremental cost-effectiveness ratio (ICER) in 2022 U.S. dollars per quality-adjusted life-year (QALY) gained. Results of Base-Case Analysis: In the base-case scenario, using drug prices from the U.S. Department of Veterans Affairs Federal Supply Schedule, apixaban dominated enoxaparin and edoxaban by being less costly and more effective. Rivaroxaban was slightly more effective than apixaban, with an ICER of $493 246. In a scenario analysis using “real-world” drug prices from GoodRx, rivaroxaban was cost-effective with an ICER of $50 053 per QALY. Results of Sensitivity Analysis: Results were highly sensitive to monthly drug costs. Probabilistic sensitivity analyses showed that at a willingness-to-pay threshold of $50 000 per QALY, apixaban was preferred in 80% of simulations. However, sensitivity analyses also demonstrated that apixaban only remained cost-effective if monthly medication costs were below $530. Above this, rivaroxaban became cost-effective. Limitations: An assumption was made that patients would continue anticoagulation indefinitely unless they suffered a major bleed. Nonmedical costs such as patient and caregiver loss of productivity were not accounted for, and long-term thrombotic complications were not explicitly modeled. Conclusion: The 3 DOACs are more effective and more cost-effective than LMWH. The most cost-effective DOAC depends on the relative cost of each of these agents. These are important considerations for treating physicians and health policymakers. Primary Funding Source: None.
Effect of Social Needs Case Management on Hospital Use Among Adult Medicaid Beneficiaries: A Randomized Study: Annals of Internal Medicine: Vol 175, No 8
Background: Case management programs assisting patients with social needs may improve health and avoid unnecessary health care use, but little is known about their effectiveness. Objective: This large-scale study assessed the population-level impact of a case management program designed to address patients' social needs. Design: Single-site randomized encouragement design with administrative enrollment from an eligible population and intention-to-treat analysis. Study participants were enrolled between August 2017 and December 2018 and followed for 1 year. (ClinicalTrials.gov: NCT04000074) Setting: Contra Costa County, an economically and culturally diverse community in the San Francisco Bay Area. Participants: 57 972 randomized enrollments of adult Medicaid patients at elevated risk for health care use (top 15%) to the intervention or control group. Intervention: Enrollees were offered 12 months of social needs case management, which provided more intensive services to patients with higher demonstrated needs. Measurements: Medical use was measured via emergency department (ED) visits and inpatient admissions, some of which were classified as avoidable. Results: Participants in the intervention group visited the ED at ratios of 0.96 (95% CI, 0.91 to 1.00) for all visits and 0.97 (CI, 0.92 to 1.03) for avoidable visits relative to the control group. The intervention group was hospitalized at ratios of 0.89 (CI, 0.81 to 0.98) for all admissions and 0.72 (CI, 0.55 to 0.88) for avoidable admissions. Limitations: Only 40% of the intervention group engaged with the program. The program was in continual development during the trial period. Conclusion: Although social needs case management programs may reduce health care use, these savings may not cover full program costs. More work is needed to identify ways to increase patient uptake and define characteristics of successful programs. Primary Funding Source: Contra Costa Health Services via the Medicaid waiver program.
Reinfection and Risk Behaviors After Treatment of Hepatitis C Virus Infection in Persons Receiving Opioid Agonist Therapy: A Cohort Study: Annals of Internal Medicine: Vol 175, No 9
Background: Hepatitis C virus (HCV) reinfection after successful treatment may reduce the benefits of cure among people who inject drugs. Objective: To evaluate the rate of HCV reinfection for 3 years after successful treatment among people receiving opioid agonist therapy (OAT). Design: A 3-year, long-term, extension study of persons enrolled in the CO-STAR (Hepatitis C Patients on Opioid Substitution Therapy Antiviral Response) study (ClinicalTrials.gov: NCT02105688). Setting: 55 clinical trial sites in 13 countries. Patients: Aged 18 years and older with chronic HCV infection with genotypes 1, 4, or 6 receiving stable OAT. Intervention: No treatments were administered. Measurements: Serum samples were assessed for HCV reinfection. Urine drug screening was performed. Results: Among 296 participants who received treatment, 286 were evaluable for reinfection and 199 were enrolled in the long-term extension study. The rate of HCV reinfection was 1.7 [95% CI, 0.8 to 3.0] per 100 person-years; 604 person-years of follow-up). A higher rate of reinfection was seen among people with recent injecting drug use (1.9 [95% CI, 0.5 to 4.8] per 100 person-years; 212 person-years). Ongoing drug use and injecting drug use were reported by 59% and 21% of participants, respectively, at the 6-month follow-up visit and remained stable during 3 years of follow-up. Limitations: Participants were required to be 80% adherent to OAT at baseline and may represent a population with higher stability and lower risk for HCV reinfection. Rate of reinfection may be underestimated because all participants did not continue in the long-term extension study; whether participants who discontinued were at higher risk for reinfection is unknown. Conclusion: Reinfection with HCV was low but was highest in the first 24 weeks after treatment completion and among people with ongoing injecting drug use and needle–syringe sharing. Primary Funding Source: Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
Impact of Hepatitis C Treatment Uptake on Cirrhosis and Mortality in Persons Who Inject Drugs: A Longitudinal, Community-Based Cohort Study: Annals of Internal Medicine: Vol 175, No 8
Background: Hepatitis C virus (HCV) infection can be cured, and the United States has joined the World Health Organization in calling for HCV elimination by 2030. However, historically low uptake of HCV treatment among people who inject drugs (PWID) threatens HCV elimination and exacerbates social and racial health disparities. Objective: To assess whether all-oral HCV treatments were accessed by PWID and reduced liver disease burden and mortality. Design: Community-based, longitudinal cohort study of persons with a history of injection drug use. Setting: Baltimore, Maryland. Participants: 1323 participants enrolled in the ALIVE (AIDS Linked to the IntraVenous Experience) study from 2006 to 2019 and chronically infected with HCV. Measurements: Liver stiffness measures (LSMs) by transient elastography, HCV RNA, and mortality from the National Death Index. Results: Among 1323 persons with evidence of chronic HCV infection at baseline, the median age was 49 years. Most were Black (82%), male (71%), and HIV-negative (66%). The proportion in whom HCV RNA was detected decreased from 100% (by definition) in 2006 to 48% in 2019. Across 10 350 valid LSMs, cirrhosis was detected in 15% of participants in 2006, 19% in 2015, and 8% in 2019. Undetectable HCV RNA was significantly associated with reduced odds of cirrhosis (adjusted odds ratio, 0.28 [95% CI, 0.17 to 0.45]) and reduced all-cause mortality risk (adjusted hazard ratio, 0.54 [CI, 0.38 to 0.77]). Limitation: Noninvasive markers of liver fibrosis have not been validated in persons with sustained virologic response. Conclusion: Many community-based PWID in Baltimore are receiving HCV treatment, which is associated with sharp decreases in liver disease and mortality. Additional efforts will be needed to reduce residual barriers to treatment and to eliminate HCV as a public health threat for PWID. Primary Funding Source: National Institutes of Health.
Evaluation and Management After Acute Left-Sided Colonic Diverticulitis: A Systematic Review: Annals of Internal Medicine: Vol 175, No 3
Background: The value of interventions used after acute colonic diverticulitis is unclear. Purpose: To evaluate postdiverticulitis colonoscopy and interventions to prevent recurrent diverticulitis. Data Sources: MEDLINE, Cochrane Central Register of Controlled Trials, Cochrane Database of Systematic Reviews, Embase, CINAHL, and ClinicalTrials.gov from 1 January 1990 through 16 November 2020. Study Selection: Comparative studies of interventions of interest reporting critical or important outcomes, and larger single-group studies to evaluate prevalence of colonoscopy findings and harms. Data Extraction: 6 researchers extracted study data and risk of bias. The team assessed strength of evidence. Data Synthesis: 19 studies evaluated colonoscopy. Risk for prevalent colorectal cancer (CRC) compared with the general population is unclear. Based on low-strength evidence, long-term CRC diagnosis is similar with or without colonoscopy. High-strength evidence indicates that risk for prevalent CRC is higher among patients with complicated diverticulitis and colonoscopy complications are rare. Based on high-strength evidence, mesalamine does not reduce recurrence risk (6 randomized controlled trials [RCTs]). Evidence on other nonsurgical interventions is insufficient. For patients with prior complicated or smoldering or frequently recurrent diverticulitis, elective surgery is associated with reduced recurrence (3 studies; high strength). In 19 studies, serious surgical complications were uncommon. Limitations: Few RCTs provided evidence. Heterogeneity of treatment effect was not adequately assessed. Conclusion: It is unclear whether patients with recent acute diverticulitis are at increased risk for prevalent CRC, but those with complicated diverticulitis are at increased risk. Mesalamine is ineffective in preventing recurrence; other nonsurgical treatments have inadequate evidence. Elective surgery reduces recurrence in patients with prior complicated or smoldering or frequently recurrent diverticulitis, but it is unclear which of these patients may benefit most. Primary Funding Source: Agency for Healthcare Research and Quality and American College of Physicians. (PROSPERO: CRD42020151246)