The Kaiser Permanente Research Bank Cancer Cohort: a collaborative resource to improve cancer care and survivorship.

BACKGROUND: The Kaiser Permanente Research Bank (KPRB) is collecting biospecimens and surveys linked to electronic health records (EHR) from approximately 400,000 adult KP members. Within the KPRB, we developed a Cancer Cohort to address issues related to cancer survival, and to understand how genetic, lifestyle and environmental factors impact cancer treatment, treatment sequelae, and prognosis. We describe the Cancer Cohort design and implementation, describe cohort characteristics after 5 years of enrollment, and discuss future directions. METHODS: Cancer cases are identified using rapid case ascertainment algorithms, linkage to regional or central tumor registries, and direct outreach to KP members with a history of cancer. Enrollment is primarily through email invitation. Participants complete a consent form, survey, and donate a blood or saliva sample. All cancer types are included. RESULTS: As of December 31, 2020, the cohort included 65,225 cases (56% female, 44% male) verified in tumor registries. The largest group was diagnosed between 60 and 69 years of age (31%) and are non-Hispanic White (83%); however, 10,076 (16%) were diagnosed at ages 18-49 years, 4208 (7%) are Hispanic, 3393 (5%) are Asian, and 2389 (4%) are Black. The median survival time is 14 years. Biospecimens are available on 98% of the cohort. CONCLUSIONS: The KPRB Cancer Cohort is designed to improve our understanding of treatment efficacy and factors that contribute to long-term cancer survival. The cohort's diversity - with respect to age, race/ethnicity and geographic location - will facilitate research on factors that contribute to cancer survival disparities.

Assessing the Safety of Direct-Acting Antiviral Agents for Hepatitis C.

Importance: Recent reports based on the US Food and Drug Administration's voluntary Adverse Events Reporting System raised questions about the safety of direct-acting antivirals (DAAs) for treatment of the hepatitis C virus (HCV). Objective: To assess the rates of adverse events in patients with HCV infection exposed to DAAs compared with those not exposed. Design, Setting, and Participants: A retrospective cohort study calculated unadjusted adverse event rates for exposed vs unexposed time, using claims and clinical data from 3 health systems between January 1, 2012, and December 31, 2017. Of 82 419 eligible adults, a total of 33 808 who met eligibility criteria (age, 18-88 years; HCV quantitative result or genotype from 2012 or later; continuously enrolled; naive to DAA treatment at baseline) were included. Marginal structural modeling methods were used to adjust time-to-event analyses for characteristics that are associated with both outcomes and probability of treatment. Interventions or Exposures: Exposure to DAAs compared with no DAA exposure. Main Outcomes and Measures: Death, multiple organ failure, liver cancer, hepatic decompensation, acute-on-chronic liver event, acute myocardial infarction, ischemic or hemorrhagic stroke, arrhythmia, acute kidney failure, nonliver cancer, hepatitis B reactivation, hospitalizations, and emergency department visits. Results: Of the 33 808 patients who met all inclusion criteria, 20 899 (61.8%) were men; mean (SD) age was 57.2 (10.6) years. In unadjusted analyses, DAA exposure was associated with significantly lower rates of death (10.7 vs 33.7 events per 1000 person-years; rate ratio [RR], 0.32, 95% CI, 0.25-0.40). Seven other unadjusted adverse clinical events ratios were below 70% and statistically significant favoring the DAA group: multiple organ failure (RR, 0.56; 95% CI, 0.44-0.72), liver cancer (RR, 0.62; 95% CI, 0.48-0.80), hepatic decompensation (RR, 0.62; 95% CI, 0.52-0.73), acute-on-chronic liver event (RR, 0.68; 95% CI, 0.56-0.84), acute myocardial infarction (RR, 0.64; 95% CI, 0.42-0.97), ischemic stroke (RR, 0.63; 95% CI, 0.42-0.95), and hemorrhagic stroke (RR, 0.47; 95% CI, 0.25-0.89); none favored the non-DAA group. In the marginal structural modeling-adjusted analysis, DAA exposure was associated with statistically significant lower odds of adverse events than non-DAA exposure for death (adjusted odds ratio [aOR], 0.42; 95% CI, 0.30-0.59), multiple organ failure (aOR, 0.67; 95% CI, 0.49-0.90), hepatic decompensation (aOR, 0.61; 95% CI, 0.49-0.76), acute-on-chronic liver event (aOR, 0.71; 95% CI, 0.56-0.91), and arrhythmia (aOR, 0.47; 95% CI, 0.25-0.88). Conclusions and Relevance: Direct-acting antiviral exposure may not be associated with higher rates of any serious adverse events, including those related to liver, kidney, and cardiovascular systems. Safety concerns based on previous reports did not appear to be supported in this study with more comprehensive data and rigorous statistical methods.

Perceptions of the appropriateness of care in California adult intensive care units.

INTRODUCTION: Increased demand for expensive intensive care unit (ICU) services may contribute to rising health-care costs. A focus on appropriate use may offer a clinically meaningful way of finding the balance. We aimed to determine the extent and characteristics of perceived inappropriate treatment among ICU doctors and nurses, defined as an imbalance between the amount or intensity of treatments being provided and the patient's expected prognosis or wishes. METHODS: This was a cross-sectional study of doctors and nurses providing care to patients in 56 adult ICUs in California between May and August 2013. In total, 1,363 doctors and nurses completed an anonymous electronic survey. RESULTS: Thirty-eight percent of 1,169 respondents (95% confidence interval (CI) 35% to 41%, 51.1% of physicians and 35.8% of nurses) identified at least one patient as receiving inappropriate treatment. Respondents most commonly reported that the amount of treatment provided was disproportionate to the patient's expected prognosis or wishes-325 out of 429 (76%, 95% CI 72% to 80%)--and that treatment was 'too much' in 93% of cases. Factors associated with perceived inappropriateness of treatment were the belief that death in their ICU is seen as a failure (odds ratio (OR) 5.75, 95% CI 2.28 to 14.53, P = 0.000), profession (doctors more than nurses) (OR 2.50, 95% CI 1.58 to 3.97, P = 0.000), lack of collaboration between doctors and nurses (OR 1.84, 95% CI 1.21 to 2.80, P = 0.004), intent to leave their job (OR 1.73, 95% CI 1.18 to 2.55, P = 0.005), and the perceived responsibility to control health-care costs (OR 1.57, 95% CI 1.05 to 2.33, P = 0.026). Providers supported formal communication training (90%, 95% CI 88% to 92%) and mandatory family meetings (89%, 95% CI 87% to 91%) as potential solutions to reduce the provision of inappropriate treatment. CONCLUSIONS: Doctors and nurses working in California ICUs frequently perceive treatment to be inappropriate. They also identified measures that could reduce the provision of inappropriate treatment.

Treatment patterns for ductal carcinoma in situ from 2000-2010 across six integrated health plans.

Considerable debate exists about the optimal treatment of ductal carcinoma in situ (DCIS). Using electronic data sources, we examined first course treatment patterns among women aged 18 years and older diagnosed with DCIS between 2000-2010 from six Kaiser Permanente (KP) regions. We calculated the proportion of patients receiving breast conserving surgery (BCS), BCS plus radiation therapy, unilateral mastectomy, bilateral mastectomy, and hormone therapy. Multinomial logistic regression was used to assess the association between patient characteristics and treatment. We included 9,437 women: 1,086 (11.5%) African-American; 1,455 (15.4%) Asian; 918 (9.7%) Hispanic; and 5,978 (63.3%) non-Hispanic white. Most cases (42.2%) received BCS plus radiation as their initial treatment. Nearly equal numbers of women received BCS without radiation (28.5%) or unilateral mastectomy (24.6%). Use of bilateral mastectomy was uncommon (4.7%), and most women (72.2%) did not receive hormone therapy has part of their first course treatment. We observed statistically significant differences in treatment patterns for DCIS by KP region and patient age. Predictably, nuclear grade and the presence of comorbidities were associated with first course treatment for DCIS. We observed statistically significant increases in BCS plus radiation therapy and bilateral mastectomy over time. Although still uncommon, the frequency of bilateral mastectomy increased from 2.7% in 2000 to 7.0% in 2010. We also observed differences in treatment by race/ethnicity. Our findings help illustrate the complex nature of DCIS treatment in the United States, and highlight the need for evidence based guidelines for DCIS care.

Developing a data infrastructure for a learning health system: the PORTAL network.

The Kaiser Permanente & Strategic Partners Patient Outcomes Research To Advance Learning (PORTAL) network engages four healthcare delivery systems (Kaiser Permanente, Group Health Cooperative, HealthPartners, and Denver Health) and their affiliated research centers to create a new national network infrastructure that builds on existing relationships among these institutions. PORTAL is enhancing its current capabilities by expanding the scope of the common data model, paying particular attention to incorporating patient-reported data more systematically, implementing new multi-site data governance procedures, and integrating the PCORnet PopMedNet platform across our research centers. PORTAL is partnering with clinical research and patient experts to create cohorts of patients with a common diagnosis (colorectal cancer), a rare diagnosis (adolescents and adults with severe congenital heart disease), and adults who are overweight or obese, including those with pre-diabetes or diabetes, to conduct large-scale observational comparative effectiveness research and pragmatic clinical trials across diverse clinical care settings.

Physician cost profiling--reliability and risk of misclassification.

BACKGROUND: Insurance products with incentives for patients to choose physicians classified as offering lower-cost care on the basis of cost-profiling tools are increasingly common. However, no rigorous evaluation has been undertaken to determine whether these tools can accurately distinguish higher-cost physicians from lower-cost physicians. METHODS: We aggregated claims data for the years 2004 and 2005 from four health plans in Massachusetts. We used commercial software to construct clinically homogeneous episodes of care (e.g., treatment of diabetes, heart attack, or urinary tract infection), assigned each episode to a physician, and created a summary profile of resource use (i.e., cost) for each physician on the basis of all assigned episodes. We estimated the reliability (signal-to-noise ratio) of each physician's cost-profile score on a scale of 0 to 1, with 0 indicating that all differences in physicians' cost profiles are due to a lack of precision in the measure (noise) and 1 indicating that all differences are due to real variation in costs of services (signal). We used the reliability results to estimate the proportion of physicians in each specialty whose cost performance would be classified inaccurately in a two-tiered insurance product in which the physicians with cost profiles in the lowest quartile were labeled as "lower cost." RESULTS: Median reliabilities ranged from 0.05 for vascular surgery to 0.79 for gastroenterology and otolaryngology. Overall, 59% of physicians had cost-profile scores with reliabilities of less than 0.70, a commonly used marker of suboptimal reliability. Using our reliability results, we estimated that 22% of physicians would be misclassified in a two-tiered system. CONCLUSIONS: Current methods for profiling physicians with respect to costs of services may produce misleading results.

Incorporating statistical uncertainty in the use of physician cost profiles.

BACKGROUND: Physician cost profiles (also called efficiency or economic profiles) compare the costs of care provided by a physician to his or her peers. These profiles are increasingly being used as the basis for policy applications such as tiered physician networks. Tiers (low, average, high cost) are currently defined by health plans based on percentile cut-offs which do not account for statistical uncertainty. In this paper we compare the percentile cut-off method to another method, using statistical testing, for identifying high-cost or low-cost physicians. METHODS: We created a claims dataset of 2004-2005 data from four Massachusetts health plans. We employed commercial software to create episodes of care and assigned responsibility for each episode to the physician with the highest proportion of professional costs. A physicians' cost profile was the ratio of the sum of observed costs divided by the sum of expected costs across all assigned episodes. We discuss a new method of measuring standard errors of physician cost profiles which can be used in statistical testing. We then assigned each physician to one of three cost categories (low, average, or high cost) using two methods, percentile cut-offs and a t-test (p-value < or = 0.05), and assessed the level of disagreement between the two methods. RESULTS: Across the 8689 physicians in our sample, 29.5% of physicians were assigned a different cost category when comparing the percentile cut-off method and the t-test. This level of disagreement varied across specialties (17.4% gastroenterology to 45.8% vascular surgery). CONCLUSIONS: Health plans and other payers should incorporate statistical uncertainty when they use physician cost-profiles to categorize physicians into low or high-cost tiers.

Assessment of the scientific soundness of clinical performance measures: a field test of the National Committee for Quality Assurance's colorectal cancer screening measure.

BACKGROUND: Relatively few studies have evaluated the scientific soundness of widely used performance measures. This study evaluated quality measures by describing a field test of the colorectal cancer screening measure included in the Health Plan Employer Data and Information Set of the National Committee for Quality Assurance. METHODS: We conducted a field test in 5 health care plans that enrolled 189 193 individuals considered eligible for colorectal cancer screening. We assessed measurement bias by calculating the prevalence of colorectal cancer screening while varying the data sources used (administrative data only, a hybrid of administrative data and medical record data, and enrollee survey data only) and the minimum required enrollment period (2-10 years). RESULTS: Across the 5 health care plans, the percentage of health care plan enrollees counted as screened varied according to the data used, ranging from 27.3% to 47.1% with the administrative data, 38.6% to 53.5% with the hybrid data, and 53.2% to 69.7% with the survey data. The relative ranking of plans also varied. One health care plan ranked first based on administrative data, second based on hybrid data, and fourth based on survey data. Survey respondents were more likely than nonrespondents to have evidence of colorectal cancer screening (62.7% vs 46.5%; P < .001). CONCLUSIONS: Administrative data seem to underestimate colorectal cancer screening and survey data seem to overestimate it, suggesting that a hybrid data approach offers the most accurate measure of screening. Implementation of performance measures should include evaluation of their scientific soundness.

Population-based assessments of ophthalmologic and audiologic follow-up in children with very low birth weight enrolled in Medicaid: a quality-of-care study.

OBJECTIVE: The purpose of our work was to determine whether children with very low birth weight (< 1500 g) who are at high risk for vision and hearing problems and enrolled in Medicaid receive recommended follow-up vision and hearing services and to examine predictors of services. PATIENTS AND METHODS: We conducted a retrospective analysis of 2182 children born in South Carolina from 1996 to 1998 with birth weights of 401 to 1499 g, gestations of > or = 24 weeks, and survival of > or = 90 days of life. Receipt of services for Medicaid-enrolled children was assessed by using a linked data set that included files from vital records, death certificates, Medicaid, Chronic Rehabilitative Services, and the Early Intervention Program. We assessed the receipt of hearing rehabilitation by 6 months of age for children with nonconductive hearing loss and routine ophthalmologic examination between ages of 1 and 2 years for all children with very low birth weight. Multivariate logistic regression was restricted to ophthalmologic examinations because of sample size. RESULTS: Among children with very low birth weight with nonconductive hearing loss, 20% received hearing rehabilitation by 6 months of age. Twenty-three percent of children with very low birth weight received an ophthalmologic examination between the ages of 1 and 2 years. Limiting our analysis to children < 1000 g or extending the measurement period to 7 months (hearing) and age 3 years (vision) did not substantially increase the percentage of children receiving the services. The receipt of an ophthalmologic examination was associated positively with Medicaid enrollment by the time of hospital discharge and birth in a level-3 hospital and negatively associated with higher birth weight, an Apgar score of > or = 7, and black maternal race. Among children born at < 1000 g, all of whom were eligible for the Early Intervention Program, the receipt of an ophthalmologic examination was positively associated with program enrollment. CONCLUSIONS: There is a shortfall in the provision of critical services for children with very low birth weight. These findings reinforce the Institute of Medicine's concerns regarding inadequate outcome data and health care services for preterm infants and support the importance of enrollment in the Early Intervention Program for children with very low birth weight.

Quality of care for hypertension in the United States.

BACKGROUND: Despite heavy recent emphasis on blood pressure (BP) control, many patients fail to meet widely accepted goals. While access and adherence to therapy certainly play a role, another potential explanation is poor quality of essential care processes (QC). Yet little is known about the relationship between QC and BP control. METHODS: We assessed QC in 12 U.S. communities by reviewing the medical records of a randomly selected group of patients for the two years preceding our study. We included patients with either a diagnosis of hypertension or two visits with BPs of >or=140/90 in their medical records. We used 28 process indicators based on explicit evidence to assess QC. The indicators covered a broad spectrum of care and were developed through a modified Delphi method. We considered patients who received all indicated care to have optimal QC. We defined control of hypertension as BP < 140/90 in the most recent reading. RESULTS: Of 1,953 hypertensive patients, only 57% received optimal care and 42% had controlled hypertension. Patients who had received optimal care were more likely to have their BP under control at the end of the study (45% vs. 35%, p = .0006). Patients were more likely to receive optimal care if they were over age 50 (76% vs. 63%, p < .0001), had diabetes (77% vs. 71%, p = .0038), coronary artery disease (87% vs. 69%, p < .0001), or hyperlipidemia (80% vs. 68%, p < .0001), and did not smoke (73% vs. 66%, p = .0005). CONCLUSIONS: Higher QC for hypertensive patients is associated with better BP control. Younger patients without cardiac risk factors are at greatest risk for poor care. Quality measurement systems like the one presented in this study can guide future quality improvement efforts.

Establishing national goals for quality improvement.

BACKGROUND: For a number of reasons, it has been difficult to garner public interest in the need to improve the quality of care delivered nationally. One possible reason for this is that the concept of quality has different meanings for different stakeholders. To make the problems of suboptimal quality more concrete and potential solutions more compelling, the Strategic Framework Board (SFB) recommended developing a set of national goals for quality improvement. OBJECTIVES: To describe the criteria by which national goals should be selected, illustrate the analytic methods that should be used to support the development of such goals, and describe and illustrate a process by which national goals could be formulated. RESEARCH DESIGN: Targeted review of literature and discussions among members of the SFB. FINDINGS: National goals have played a key role in making progress under the Healthy People 2000 and Health People 2010 initiatives. The recommended process will involve assembling key evidence as well as engaging in a consensus process. CONCLUSIONS: Developing a set of national goals for quality improvement is a key activity for a national quality measurement and reporting system to undertake. The steps outlined here represent a feasible and productive method for accomplishing this objective.