Patterns of Medical Care Cost by Service Type for Patients With Recurrent and De Novo Advanced Cancer.

OBJECTIVES: There is limited knowledge about the cost patterns of patients who receive a diagnosis of de novo and recurrent advanced cancers in the United States. METHODS: Data on patients who received a diagnosis of de novo stage IV or recurrent breast, colorectal, or lung cancer between 2000 and 2012 from 3 integrated health systems were used to estimate average annual costs for total, ambulatory, inpatient, medication, and other services during (1) 12 months preceding de novo or recurrent diagnosis (preindex) and (2) diagnosis month through 11 months after (postindex), from the payer perspective. Generalized linear regression models estimated costs adjusting for patient and clinical factors. RESULTS: Patients who developed a recurrence <1 year after their initial cancer diagnosis had significantly higher total costs in the preindex period than those with recurrence ≥1 year after initial diagnosis and those with de novo stage IV disease across all cancers (all P < .05). Patients with de novo stage IV breast and colorectal cancer had significantly higher total costs in the postindex period than patients with cancer recurrent in <1 year and ≥1 year (all P < .05), respectively. Patients in de novo stage IV and those with recurrence in ≥1 year experienced significantly higher postindex costs than the preindex period (all P < .001). CONCLUSIONS: Our findings reveal distinct cost patterns between patients with de novo stage IV, recurrent <1-year, and recurrent ≥1-year cancer, suggesting unique care trajectories that may influence resource use and planning. Future cost studies among patients with advanced cancer should account for de novo versus recurrent diagnoses and timing of recurrence to obtain estimates that accurately reflect these care pattern complexities.

Health issues and healthcare utilization among adults who reported exposure to tear gas during 2020 Portland (OR) protests: a cross-sectional survey.

BACKGROUND: Repeated use of chemical irritants for crowd-control by local and federal law enforcement during sustained racial justice protests in the U.S. has raised concerns about potential adverse health effects. The objective of this study was to describe the health consequences of exposure to tear gas agents and associated healthcare utilization among adults reporting recent exposure to tear gas. METHODS: A cross-sectional, self-administered web-based survey of a convenience sample of 2257 adults reporting recent exposure to tear gas in Portland, Oregon (U.S.), administered between July 30, 2020-August 20, 2020. Descriptive analyses were conducted on socioeconomic characteristics, reported health issues, utilization of healthcare services, and frequency of reported exposure to tear gas. Associations between reported mental health issues, healthcare utilization and race and/or ethnic categories were assessed using a chi-square test. For tests of association, racial and/or ethnic categories were divided into White/Non-Hispanic only and all other racial/ethnic categories due to a small number of Black, American Indian or Alaska Native, Asian/Pacific Islander, Hispanic participants and participants with multiple race and/or ethnic background. Effect sizes for the differences were expressed as Cramer's V, a metric that measures associations between nominal responses. The Cochran-Armitage trend test was used to assess the relationship between health issues and the number of reported days of exposure to tear gas (i.e., a proxy dose of exposure) grouped into 1 day, 2-4 days, and ≥ 5 days. Missing data (item non-response) were omitted from the analysis. RESULTS: Almost all respondents (2116; 93.8%) reported physical (2114; 93.7%) or psychological (1635; 72.4%) health issues experienced immediately after (2105; 93.3%) or days following (1944; 86.1%) the exposure. A slightly higher proportion experienced delayed head or gastrointestinal tract issues compared with immediate complaints. The majority (1233; 54.6%) reported receiving or planning to seek medical or mental care. We observed a positive exposure-response trend for all except mouth-related delayed issues (p < 0.01). CONCLUSION: Persons who reported exposer to tear gas agents also reported physical and psychological health issues over a multiple-day period. Health issues reported increased with the frequency of reported exposure, indicating a potential dose-response; these health effects often led to healthcare utilization. This study provides evidence of potential unexpected harms of tear gas in civilians.

The influence of multi-morbidities on colorectal cancer screening recommendations and completion.

PURPOSE: Patients' chronic disease burden can influence the likelihood that providers will recommend cancer screening and that patients will participate in it. Using data from the STOP CRC pragmatic study, we examined associations between chronic disease burden and colorectal cancer screening recommendation and use. METHODS: Participating STOP CRC clinics (n = 26) received either usual care or training to implement a mailed fecal immunochemical test (FIT) outreach program. Selected clinic patients (n = 60,187 patients) were aged 50-74 and overdue for colorectal cancer screening. We used logistic regression to examine the associations between FIT recommendations and completion and patients' chronic disease burden, calculated using the Charlson Comorbidity Index and the Chronic Illness and Disability Payment System. RESULTS: For each index, FIT recommendation odds were 8-9% higher among individuals with minimal chronic disease burden and 13-23% lower among individuals with high chronic disease burden (inverted U-shaped association). Among adults who were ordered a FIT, FIT completion odds were 20% lower for individuals with any, versus no, chronic condition and diminished with increasing disease burden (inverse linear association). CONCLUSIONS: Analysis showed an inverted U-shaped association between patients' chronic disease burden and providers' recommendation of a FIT and an inverse linear association between patients' chronic disease burden and FIT completion. ClinicalTrials.gov registration: NCT01742065.

Association of the Intensity of Diagnostic Evaluation With Outcomes in Incidentally Detected Lung Nodules.

Importance: Whether guideline-concordant lung nodule evaluations lead to better outcomes remains unknown. Objective: To examine the association between the intensity of lung nodule diagnostic evaluations and outcomes, safety, and health expenditures. Design, Setting, and Participants: This comparative effectiveness research study analyzed health plan enrollees at Kaiser Permanente Washington in Seattle, Washington, and Marshfield Clinic in Marshfield, Wisconsin, with an incidental lung nodule detected between January 1, 2005, and December 31, 2015. Included patients were 35 years or older, had no high suspicion of infection, had no history of malignant neoplasm, and had no evidence of advanced lung cancer on nodule detection. Data analysis was conducted from January 7 to August 19, 2020. Exposures: With the 2005 Fleischner Society guidelines (selected for their applicability to the time frame under investigation) as the comparator, 2 other intensities of lung nodule evaluation were defined. Guideline-concordant evaluation followed the guidelines. Less intensive evaluation was the absence of recommended testing, longer-than-recommended surveillance intervals, or less invasive testing than recommended. More intensive evaluation consisted of testing when the guidelines recommended no further testing, shorter-than-recommended surveillance intervals, or more invasive testing than recommended. Main Outcomes and Measures: The main outcome was the proportion of patients with lung cancer who had stage III or IV disease, radiation exposure, procedure-related adverse events, and health expenditures 2 years after nodule detection. Results: Among the 5057 individuals included in this comparative effectiveness research study, 1925 (38%) received guideline-concordant, 1863 (37%) less intensive, and 1269 (25%) more intensive diagnostic evaluations. The entire cohort comprised 2786 female patients (55%), and the mean (SD) age was 67 (13) years. Adjusted analyses showed that compared with guideline-concordant evaluations, less intensive evaluations were associated with fewer procedure-related adverse events (risk difference [RD], -5.9%; 95% CI, -7.2% to -4.6%), lower mean radiation exposure (-9.5 milliSieverts [mSv]; 95% CI, -10.3 mSv to -8.7 mSv), and lower mean health expenditures (-$10 916; 95% CI, -$16 112 to -$5719); no difference in stage III or IV disease was found among patients diagnosed with lung cancer (RD, 4.6%; 95% CI, -22% to +31%). More intensive evaluations were associated with more procedure-related adverse events (RD, +8.1%; 95% CI, +5.6% to +11%), higher mean radiation exposure (+6.8 mSv; 95% CI, +5.8 mSv to +7.8 mSv), and higher mean health expenditures ($20 132; 95% CI, +$14 398 to +$25 868); no difference in stage III or IV disease was observed (RD, -0.5%; 95% CI, -28% to +27%). Conclusions and Relevance: This study found inconclusive evidence of an association between less intensive diagnostic evaluations and more advanced stage at lung cancer diagnosis compared with guideline-concordant care; higher intensities of diagnostic evaluations were associated with greater procedural complications, radiation exposure, and expenditures. These findings underscore the need for more evidence on better ways to evaluate lung nodules and to avoid unnecessarily intensive diagnostic evaluations of lung nodules.

Factors Affecting Adherence in a Pragmatic Trial of Annual Fecal Immunochemical Testing for Colorectal Cancer.

BACKGROUND: Colorectal cancer screening by fecal immunochemical test (FIT) reduces the burden of colorectal cancer. However, effectiveness relies on annual adherence, which presents challenges for clinic staff and patients. OBJECTIVE: Describe FIT return rates and identify factors associated with FIT adherence over 2 years in a mailed FIT outreach program in federally qualified health centers. DESIGN: Observational study nested in the Strategies and Opportunities to Stop Colon Cancer in Priority Populations (STOP CRC) trial. Five thousand one hundred ninety-five patients had an initial FIT order and were followed for ≥ 2 years (3574 also had a FIT order in the second year). MAIN MEASURES: FIT return percent in each year and patient- and neighborhood-level characteristics associated with FIT adherence. KEY RESULTS: Overall, the proportion of FIT orders that were completed was 46% in the patients' first year and 41% in the patients' second year. Of the 5195 patients with a FIT order in year 1, 3574 (69%) also had a FIT order in year 2 (71% of year 1 adherers and 67% of year 1 non-adherers, p = 0.009). Among those with a FIT order in the second year, the FIT return rate was about twice as high among those who were adherent in the first year (952/1674, or 57%) as among those who were not (531/1900, or 28%, p < 0.0001). Patient-level characteristics associated with higher odds of FIT return were a history of FIT screening at baseline, age over 65 (vs 50-65), no current tobacco use, recent receipt of a mammogram or flu vaccine, Asian ancestry (compared to non-Hispanic white), and non-English preference. The only neighborhood factor associated with lower FIT return rate was patient's larger residential city size. CONCLUSION: Our findings can inform the customization of programs to promote FIT return among patients who receive care at federally qualified health centers. TRIAL REGISTRATION: http://www.clinicaltrials.gov.

Positive predictive values of fecal immunochemical tests used in the STOP CRC pragmatic trial.

Annual fecal immunochemical testing (FIT) is cost-effective for colorectal cancer (CRC) screening. However, FIT positivity rates and positive predictive value (PPV) can vary substantially, with false-positive (FP) results adding to colonoscopy burden without improving cancer detection. Our objective was to describe FIT PPV and the factors associated with FP results among patients undergoing CRC screening. In an ongoing pragmatic clinical trial of mailed-FIT outreach, clinics delivered one of three FIT brands (InSure, OC-Micro, and Hemosure). Patients who had a positive FIT result and a follow-up colonoscopy were included in this analysis (N = 1130). Patients' demographic and medical histories were abstracted from electronic health records (EHR). Associations with a FP result (ie, a positive FIT result with no evidence of advanced neoplasia during follow-up colonoscopy) were evaluated for FIT brand and patient factors using mixed-effects multivariable logistic regression. The mean proportion of FIT-positive results ranged from 8% in centers using the OC-Micro test to 21% for Hemosure. PPVs for advanced neoplasia were 0.30 to 0.17, respectively (P for χ2  = 0.08). In multivariable-adjusted models, use of Hemosure was associated with greater odds of a FP result than OC-Micro (OR = 2.00, 95% CI: 0.47-8.56) or InSure (OR = 1.72, 95% CI: 0.44-6.68). However, only female sex (OR = 1.58, 95% CI: 1.19-2.10) and history of a colorectal condition (OR = 2.17, 95% CI: 1.13-4.15) were significantly associated with FP. In conclusion, FIT positivity varied by brand, and FP results differed by patient factors available through the EHR. These results can be used to minimize the frequency of FP results, reducing patient distress and colonoscopy burden.

Effectiveness of a Mailed Colorectal Cancer Screening Outreach Program in Community Health Clinics: The STOP CRC Cluster Randomized Clinical Trial.

Importance: Approximately 24 million US individuals receive care at federally qualified health centers, which historically have low rates of colorectal cancer screening. The US Preventive Services Task Force recommends routine colorectal cancer screening for individuals aged 50 to 75 years. Objective: To determine the effectiveness of an electronic health record (EHR)-embedded mailed fecal immunochemical test (FIT) outreach program implemented in health centers as part of standard care. Design, Setting, and Participants: This cluster randomized pragmatic clinical trial was conducted in 26 federally qualified health center clinics, representing 8 health centers in Oregon and California, randomized to intervention (n = 13) or usual care (n = 13). All participants were overdue for colorectal cancer screening during the accrual interval (February 4, 2014 to February 3, 2015). Interventions: Electronic health record-embedded tools to identify eligible adults and to facilitate implementation of a stepwise mailed intervention involving (1) an introductory letter, (2) a mailed FIT, and (3) a reminder letter; training, collaborative learning, and facilitation through a practice improvement process. Main Outcomes and Measures: Effectiveness was measured as clinic-level proportions of adults who completed a FIT, and secondarily, any colorectal cancer screening within 12 months of accrual or by August 3, 2015. Implementation was measured as clinic-level proportions of adults who were mailed an introductory letter and ordered a FIT. Results: Twenty-six clinics with 41 193 adults (mean [SD] age, 58.5 [6.3] years; 22 994 women) were randomized to receive the direct mail colorectal screening intervention (13 clinics; 21 134 patients) or usual care (13 clinics; 20 059 patients). Compared with usual care clinics, intervention clinics had significantly higher adjusted clinic-level proportion of participants who completed a FIT (13.9% vs 10.4%; difference, 3.4 percentage points; 95% CI, 0.1%-6.8%) and any colorectal cancer screening (18.3% vs 14.5%; difference, 3.8 percentage points; 95% CI, 0.6%-7.0%). We observed large variation across health centers in effectiveness (FIT completion differences range, -7.4 percentage points to 17.6 percentage points) and implementation (proportion who were mailed a FIT range, 6.5% to 68.2%). The number needed to mail to achieve a completed FIT was 4.8 overall, and 4.0 in clinics that mailed a FIT reminder. Conclusions and Relevance: An EHR-embedded mailed FIT outreach intervention significantly improved rates of FIT completion and rates of any colorectal cancer screening. Higher rates of colorectal cancer screening occurred in clinics that successfully implemented the mailed outreach program. Trial Registration: ClinicalTrials.gov identifier: NCT01742065.

All-Cause Mortality and Progression Risks to Hepatic Decompensation and Hepatocellular Carcinoma in Patients Infected With Hepatitis C Virus.

BACKGROUND: A key question in care of patients with chronic hepatitis C virus (HCV) infection is beginning treatment immediately vs delaying treatment. Risks of mortality and disease progression in "real world" settings are important to assess the implications of delaying HCV treatment. METHODS: This was a cohort study of HCV patients identified from 4 integrated health systems in the United States who had liver biopsies during 2001-2012. The probabilities of death and progression to hepatocellular carcinoma, hepatic decompensation (hepatic encephalopathy, esophageal varices, ascites, or portal hypertension) or liver transplant were estimated over 1, 2, or 5 years by fibrosis stage (Metavir F0-F4) determined by biopsy at beginning of observation. RESULTS: Among 2799 HCV-monoinfected patients who had a qualifying liver biopsy, the mean age at the time of biopsy was 50.7 years. The majority were male (58.9%) and non-Hispanic white (66.9%). Over a mean observation of 5.0 years, 261 (9.3%) patients died and 34 (1.2%) received liver transplants. At 5 years after biopsy, the estimated risk of progression to hepatic decompensation or hepatocellular carcinoma was 37.2% in stage F4, 19.6% in F3, 4.7% in F2, and 2.3% in F0-F1 patients. Baseline biopsy stage F3 or F4 and platelet count below normal were the strongest predictors of progression to hepatic decompensation or hepatocellular carcinoma. CONCLUSIONS: The risks of death and progression to liver failure varied greatly by fibrosis stage. Clinicians and policy makers could use these progression risk data in prioritization and in determining the timing of treatment for patients in early stages of liver disease.

A standardized relative resource cost model for medical care: application to cancer control programs.

Medicare data represent 75% of aged and permanently disabled Medicare beneficiaries enrolled in the fee-for-service (FFS) indemnity option, but the data omit 25% of beneficiaries enrolled in Medicare Advantage health maintenance organizations (HMOs). Little research has examined how longitudinal patterns of utilization differ between HMOs and FFS. The Burden of Cancer Study developed and implemented an algorithm to assign standardized relative costs to HMO and Medicare FFS data consistently across time and place. Medicare uses 15 payment systems to reimburse FFS providers for covered services. The standardized relative resource cost algorithm (SRRCA) adapts these various payment systems to utilization data. We describe the rationale for modifications to the Medicare payment systems and discuss the implications of these modifications. We applied the SRRCA to data from four HMO sites and the linked Surveillance, Epidemiology, and End Results-Medicare data. Some modifications to Medicare payment systems were required, because data elements needed to categorize utilization were missing from both data sources. For example, data were not available to create episodes for home health services received, so we assigned costs per visit based on visit type (nurse, therapist, and aide). For inpatient utilization, we modified Medicare's payment algorithm by changing it from a flat payment per diagnosis-related group to daily rates for diagnosis-related groups to differentiate shorter versus longer stays. The SRRCA can be used in multiple managed care plans and across multiple FFS delivery systems within the United States to create consistent relative cost data for economic analyses. Prior to international use of the SRRCA, data need to be standardized.

Hormone therapy and physical function change among older women in the Women's Health Initiative: a randomized controlled trial.

OBJECTIVE: Although estrogen may be linked to biological pathways that maintain higher physical function, the evidence is derived mostly from observational epidemiology and therefore has numerous limitations. We examined whether hormone therapy affected physical function in women 65 to 79 years of age at enrollment. METHODS: This study involves an analysis of the Women's Health Initiative randomized controlled trials of hormone therapy in which 922 nondisabled women who had previous hysterectomies were randomized to receive estrogen therapy or a placebo and 1,458 nondisabled women with intact uteri were randomized to receive estrogen + progestin therapy or a placebo. Changes in physical function were analyzed for treatment effect, and subgroup differences were evaluated. All women completed performance-based measures of physical function (grip strength, chair stands, and timed walk) at baseline. These measures were repeated after 1, 3, and 6 years. RESULTS: Overall, participants' grip strength declined by 12.0%, chair stands declined by 3.5%, and walk pace slowed by 11.4% in the 6 years of follow-up (all P values <0.0001). Hormone therapy, as compared with placebo, was not associated with an increased or decreased risk of decline in physical function in either the intention-to-treat analyses or in analyses restricted to participants who were compliant in taking study pills. CONCLUSIONS: Hormone therapy provided no overall protection against functional decline in nondisabled postmenopausal women 65 years or older in 6 years of follow-up. This study did not address the influence of hormone therapy for women of younger ages.