A logic model for precision medicine implementation informed by stakeholder views and implementation science.

PURPOSE: Precision medicine promises to improve patient outcomes, but much is unknown about its adoption within health-care systems. A comprehensive implementation plan is needed to realize its benefits. METHODS: We convened 80 stakeholders for agenda setting to inform precision medicine policy, delivery, and research. Conference proceedings were audio-recorded, transcribed, and thematically analyzed. We mapped themes representing opportunities, challenges, and implementation strategies to a logic model, and two implementation science frameworks provided context. RESULTS: The logic model components included inputs: precision medicine infrastructure (clinical, research, and information technology), big data (from data sources to analytics), and resources (e.g., workforce and funding); activities: precision medicine research, practice, and education; outputs: precision medicine diagnosis; outcomes: personal utility, clinical utility, and health-care utilization; and impacts: precision medicine value, equity and access, and economic indicators. Precision medicine implementation challenges include evidence gaps demonstrating precision medicine utility, an unprepared workforce, the need to improve precision medicine access and reduce variation, and uncertain impacts on health-care utilization. Opportunities include integrated health-care systems, partnerships, and data analytics to support clinical decisions. Examples of implementation strategies to promote precision medicine are: changing record systems, data warehousing techniques, centralized technical assistance, and engaging consumers. CONCLUSION: We developed a theory-based, context-specific logic model that can be used by health-care organizations to facilitate precision medicine implementation.

Colonoscopy vs. Fecal Immunochemical Test in Reducing Mortality From Colorectal Cancer (CONFIRM): Rationale for Study Design.

RATIONALE: Colorectal cancer (CRC) is preventable through screening, with colonoscopy and fecal occult blood testing comprising the two most commonly used screening tests. Given the differences in complexity, risk, and cost, it is important to understand these tests' comparative effectiveness. STUDY DESIGN: The CONFIRM Study is a large, pragmatic, multicenter, randomized, parallel group trial to compare screening with colonoscopy vs. the annual fecal immunochemical test (FIT) in 50,000 average risk individuals. CONFIRM examines whether screening colonoscopy will be superior to a FIT-based screening program in the prevention of CRC mortality measured over 10 years. Eligible individuals 50-75 years of age and due for CRC screening are recruited from 46 Veterans Affairs (VA) medical centers. Participants are randomized to either colonoscopy or annual FIT. Results of colonoscopy are managed as per usual care and study participants are assessed for complications. Participants testing FIT positive are referred for colonoscopy. Participants are surveyed annually to determine if they have undergone colonoscopy or been diagnosed with CRC. The primary endpoint is CRC mortality. The secondary endpoints are (1) CRC incidence (2) complications of screening colonoscopy, and (3) the association between colonoscopists' characteristics and neoplasia detection, complications and post-colonoscopy CRC. CONFIRM leverages several key characteristics of the VA's integrated healthcare system, including a shared medical record with national databases, electronic CRC screening reminders, and a robust national research infrastructure with experience in conducting large-scale clinical trials. When completed, CONFIRM will be the largest intervention trial conducted within the VA (ClinicalTrials.gov identifier: NCT01239082).

The accuracy and completeness for receipt of colorectal cancer care using Veterans Health Administration administrative data.

BACKGROUND: The National Comprehensive Cancer Network and the American Society of Clinical Oncology have established guidelines for the treatment and surveillance of colorectal cancer (CRC), respectively. Considering these guidelines, an accurate and efficient method is needed to measure receipt of care. METHODS: The accuracy and completeness of Veterans Health Administration (VA) administrative data were assessed by comparing them with data manually abstracted during the Colorectal Cancer Care Collaborative (C4) quality improvement initiative for 618 patients with stage I-III CRC. RESULTS: The VA administrative data contained gender, marital, and birth information for all patients but race information was missing for 62.1% of patients. The percent agreement for demographic variables ranged from 98.1-100%. The kappa statistic for receipt of treatments ranged from 0.21 to 0.60 and there was a 96.9% agreement for the date of surgical resection. The percentage of post-diagnosis surveillance events in C4 also in VA administrative data were 76.0% for colonoscopy, 84.6% for physician visit, and 26.3% for carcinoembryonic antigen (CEA) test. CONCLUSIONS: VA administrative data are accurate and complete for non-race demographic variables, receipt of CRC treatment, colonoscopy, and physician visits; but alternative data sources may be necessary to capture patient race and receipt of CEA tests.

Population-based assessment of cancer survivors' financial burden and quality of life: a prospective cohort study.

PURPOSE: The impact of financial burden among patients with cancer has not yet been measured in a way that accounts for inter-relationships between quality of life, perceived quality of care, disease status, and sociodemographic characteristics. PATIENTS AND METHODS: In a national, prospective, observational, population- and health care systems-based cohort study, patients with colorectal or lung cancer were enrolled from 2003 to 2006 within 3 months of diagnosis. For this analysis, surviving patients who were either disease free or had advanced disease were resurveyed a median 7.3 years from diagnosis. Structural equation modeling was used to investigate relationships between financial burden, quality of life, perceived quality of care, and sociodemographic characteristics. RESULTS: Among 1,000 participants enrolled from five geographic regions, five integrated health care systems, or 15 Veterans Administration Hospitals, 89% (n = 889) were cancer free, and 11% (n = 111) had advanced cancer. Overall, 48% (n = 482) reported difficulties living on their household income, and 41% (n = 396) believed their health care to be "excellent." High financial burden was associated with lower household income (adjusted odds ratio [OR] = 0.61 per $20k per year, P < .001) and younger age (adjusted OR = 0.63 per 10 years; P < .001). High financial burden was also associated with poorer quality of life (adjusted beta = -0.06 per burden category; P < .001). Better quality of life was associated with fewer perceptions of poorer quality of care (adjusted OR = 0.85 per 0.10 EuroQol units; P < .001). CONCLUSION: Financial burden is prevalent among cancer survivors and is related to patients' health-related quality of life. Future studies should consider interventions to improve patient education and engagement with regard to financial burden.

Implementation of new clinical programs in the VHA healthcare system: the importance of early collaboration between clinical leadership and research.

Collaboration between policy, research, and clinical partners is crucial to achieving proven quality care. The Veterans Health Administration has expended great efforts towards fostering such collaborations. Through this, we have learned that an ideal collaboration involves partnership from the very beginning of a new clinical program, so that the program is designed in a way that ensures quality, validity, and puts into place the infrastructure necessary for a reliable evaluation. This paper will give an example of one such project, the Lung Cancer Screening Demonstration Project (LCSDP). We will outline the ways that clinical, policy, and research partners collaborated in design, planning, and implementation in order to create a sustainable model that could be rigorously evaluated for efficacy and fidelity. We will describe the use of the Donabedian quality matrix to determine the necessary characteristics of a quality program and the importance of the linkage with engineering, information technology, and clinical paradigms to connect the development of an on-the-ground clinical program with the evaluation goal of a learning healthcare organization. While the LCSDP is the example given here, these partnerships and suggestions are salient to any healthcare organization seeking to implement new scientifically proven care in a useful and reliable way.

Patient-reported quality of supportive care among patients with colorectal cancer in the Veterans Affairs Health Care System.

PURPOSE: High-quality supportive care is an essential component of comprehensive cancer care. We implemented a patient-centered quality of cancer care survey to examine and identify predictors of quality of supportive care for bowel problems, pain, fatigue, depression, and other symptoms among 1,109 patients with colorectal cancer. PATIENTS AND METHODS: Patients with new diagnosis of colorectal cancer at any Veterans Health Administration medical center nationwide in 2008 were ascertained through the Veterans Affairs Central Cancer Registry and sent questionnaires assessing a variety of aspects of patient-centered cancer care. We received questionnaires from 63% of eligible patients (N = 1,109). Descriptive analyses characterizing patient experiences with supportive care and binary logistic regression models were used to examine predictors of receipt of help wanted for each of the five symptom categories. RESULTS: There were significant gaps in patient-centered quality of supportive care, beginning with symptom assessment. In multivariable modeling, the impact of clinical factors and patient race on odds of receiving wanted help varied by symptom. Coordination of care quality predicted receipt of wanted help for all symptoms, independent of patient demographic or clinical characteristics. CONCLUSION: This study revealed substantial gaps in patient-centered quality of care, difficult to characterize through quality measurement relying on medical record review alone. It established the feasibility of collecting patient-reported quality measures. Improving quality measurement of supportive care and implementing patient-reported outcomes in quality-measurement systems are high priorities for improving the processes and outcomes of care for patients with cancer.

Examining potential colorectal cancer care disparities in the Veterans Affairs health care system.

PURPOSE: Racial disparities in cancer treatment and outcomes are a national problem. The nationwide Veterans Affairs (VA) health system seeks to provide equal access to quality care. However, the relationship between race and care quality for veterans with colorectal cancer (CRC) treated within the VA is poorly understood. We examined the association between race and receipt of National Comprehensive Cancer Network guideline-concordant CRC care. PATIENTS AND METHODS: This was an observational, retrospective medical record abstraction of patients with CRC treated in the VA. Two thousand twenty-two patients (white, n = 1,712; African American, n = 310) diagnosed with incident CRC between October 1, 2003, and March 31, 2006, from 128 VA medical centers, were included. We used multivariable logistic regression to examine associations between race and receipt of guideline-concordant care (computed tomography scan, preoperative carcinoembryonic antigen, clear surgical margins, medical oncology referral for stages II and III, fluorouracil-based adjuvant chemotherapy for stage III, and surveillance colonoscopy for stages I to III). Explanatory variables included demographic and disease characteristics. RESULTS: There were no significant racial differences for receipt of guideline-concordant CRC care. Older age at diagnosis was associated with reduced odds of medical oncology referral and surveillance colonoscopy. Presence of cardiovascular comorbid conditions was associated with reduced odds of medical oncology referral (odds ratio, 0.65; 95% CI, 0.50 to 0.89). CONCLUSION: In these data, we observed no evidence of racial disparities in CRC care quality. Future studies could examine causal pathways for the VA's equal, quality care and ways to translate the VA's success into other hospital systems.

An examination of racial differences in process and outcome of colorectal cancer care quality among users of the veterans affairs health care system.

BACKGROUND: Veterans Affairs (VA) manages the largest US integrated health care system. Although quality of VA colorectal cancer (CRC) care is well chronicled, there is a paucity of research examining racial differences in this care. This study examines racial differences in 2 dimensions of quality of VA CRC care: processes (time to treatment) and outcomes (survival). PATIENTS AND METHODS: Retrospective data were from the VA External Peer Review Program (EPRP), a nationwide VA quality-monitoring program. Study patients were white and African American men diagnosed with nonmetastatic CRC between 2003 and 2006 who received definitive CRC surgery. We examined 3 quality indicators: time from (1) surgery to initiation of adjuvant chemotherapy (stages II-III disease), (2) surgery to surveillance colonoscopy (stages I-III disease), and (3) surgery to death (stages I-III disease). Unadjusted analyses used log-rank and Wilcoxon tests. Adjusted analyses used Cox proportional hazard models. RESULTS: In unadjusted analyses, there was no evidence of racial differences across the 3 quality measures. In adjusted Cox regression, there were no racial differences in time to initiation of chemotherapy (hazard ratio [HR], 0.82; P = .61) or surgery to death (HR, 0.94; P = .49). In adjusted Cox regression, among those receiving colonoscopy within 7 to 18 months after surgery, white patients experienced slightly shorter median times to surveillance colonoscopy than did African American patients (367 vs. 383 days; HR, 0.63; P = .02). CONCLUSION: Other than a small racial difference in timing of surveillance colonoscopy, there was little evidence of racial differences in quality of CRC care among VA health care system users.

Disparities in lung cancer staging with positron emission tomography in the Cancer Care Outcomes Research and Surveillance (CanCORS) study.

INTRODUCTION: Disparities in treatment exist for nonwhite and Hispanic patients with non-small cell lung cancer, but little is known about disparities in the use of staging tests or their underlying causes. METHODS: Prospective, observational cohort study of 3638 patients with newly diagnosed non-small cell lung cancer from 4 large, geographically defined regions, 5 integrated health care systems, and 13 VA health care facilities. RESULTS: Median age was 69 years, 62% were men, 26% were Hispanic or nonwhite, 68% graduated high school, 50% had private insurance, and 41% received care in the VA or another integrated health care system. After adjustment, positron emission tomography (PET) use was 13% lower among nonwhites and Hispanics than non-Hispanic whites (risk ratio [RR] 0.87, 95% confidence interval [CI] 0.77-0.97), 13% lower among those with Medicare than those with private insurance (RR 0.87, 95% CI 0.76-0.99), and 24% lower among those with an elementary school education than those with a graduate degree (RR 0.76, 95% CI 0.57-0.98). Disparate use of PET was not observed among patients who received care in an integrated health care setting, but the association between race/ethnicity and PET use was similar in magnitude across all other subgroups. Further analysis showed that income, education, insurance, and health care setting do not explain the association between race/ethnicity and PET use. CONCLUSIONS: Hispanics and nonwhites with non-small cell lung cancer are less likely to receive PET imaging. This finding is consistent across subgroups and not explained by differences in income, education, or insurance coverage.

Quality of nonmetastatic colorectal cancer care in the Department of Veterans Affairs.

PURPOSE: The Veterans Affairs (VA) healthcare system treats approximately 3% of patients with cancer in the United States each year. We measured the quality of nonmetastatic colorectal cancer (CRC) care in VA as indicated by concordance with National Comprehensive Cancer Network practice guidelines (six indicators) and timeliness of care (three indicators). PATIENTS AND METHODS: A retrospective medical record abstraction was done for 2,492 patients with incident stages I to III CRC diagnosed between October 1, 2003, and March 31, 2006, who underwent definitive CRC surgery. Patients were treated at one or more of 128 VA medical centers. The proportion of patients receiving guideline-concordant care and time intervals between care processes were calculated. RESULTS: More than 80% of patients had preoperative carcinoembryonic antigen determination (ie, stages II to III disease) and documented clear surgical margins (ie, stages II to III disease). Between 72% and 80% of patients had appropriate referral to a medical oncologist (ie, stages II to III disease), preoperative computed tomography scan of the abdomen and pelvis (ie, stages II to III disease), and adjuvant fluorouracil-based chemotherapy (ie, stage III disease). Less than half of patients with stages I to III CRC (43.5%) had a follow-up colonoscopy 7 to 18 months after surgery. The mean number of days between major treatment events included the following: 26.6 days (standard deviation [SD], 38.2; median, 20 days) between diagnosis and initiation of treatment (in stages II to III disease); 64.8 [corrected] days (SD, 54.9; median, 50 days) between definitive surgery and start of adjuvant chemotherapy (in stages II to III disease); and 444.2 [corrected] days (SD, 182.1; median, 393 days) between definitive surgery and follow-up colonoscopies (in stages I to III disease). CONCLUSION: Although there is opportunity for improvement in the area of cancer surveillance, the VA performs well in meeting established guidelines for diagnosis and treatment of CRC.

Validation of a questionnaire to assess self-reported colorectal cancer screening status using face-to-face administration.

PURPOSE: The aim of this study was to assess the accuracy of a National Cancer Institute (NCI)-developed colorectal cancer screening questionnaire. METHODS: We conducted 36 cognitive interviews and made iterative changes to the questionnaire to improve comprehension. The revised questionnaire was administered face-to-face to 201 participants. The primary outcome was agreement between questionnaire responses and medical records for whether or not a participant was up-to-date for any colorectal cancer screening test. RESULTS: Comprehension of descriptions and questions was generally good; however, the barium enema description required several revisions. The sensitivity of the questionnaire for up-to-date screening status was 94%, specificity 63%, and concordance 88%. CONCLUSIONS: The modified questionnaire was highly sensitive for determining if a person was up-to-date for any colorectal cancer screening test, although the specificity was low. Given the difficulty of obtaining all relevant records, self-report using this questionnaire is a reasonable option for identifying people who have undergone testing.

Colorectal cancer screening in young patients with poor health and severe comorbidity.

BACKGROUND: Young patients with poor health and a high risk of mortality from comorbid diseases have less chance of deriving a survival benefit from colorectal cancer screening. The aim of this study was to examine the relationship between colorectal cancer screening, self-reported health status, and comorbidity in a cohort of young patients, defined as patients between the ages of 50 and 64 years. METHODS: This was a single-center study conducted at a Veterans Affairs Medical Center from October 1, 1996, to March 30, 2004. Colorectal cancer screening information was obtained from 861 outpatients who completed the 36-Item Short-Form Health Survey (measure of health status) and the Kaplan-Feinstein Index (comorbidity score). Rates of screening were examined by age, physical component summary score, and severity of comorbid illnesses. RESULTS: Of the veterans, 45.9% had undergone screening within 5 years of their index visit. Screening rates were high among patients with moderate (44.9%) and severe (45.8%) comorbidities. When stratified by age group and physical component summary quartile, there was a trend toward increasing screening rates with better health status in the 50- to 54- and 55- to 59-year age groups. In the 60- to 64-year age group, high screening rates for patients with poorer health were observed: physical component summary quartiles 1 and 2, 55.7% and 54.2%, respectively. Fifty-two patients died during the 5-year follow-up; 37 (71.2%) had undergone screening for colorectal cancer. CONCLUSIONS: Young patients with potentially reduced life expectancy are being screened for colorectal cancer at relatively high rates. Comprehensive assessment of health status and comorbidity should guide cancer screening decisions, especially in individuals with reduced life expectancy who may obtain the least benefit from screening.

Cost-effectiveness of screening the average-risk population for colorectal cancer.

This article reviews several of the recent models addressing the cost-effectiveness of colorectal cancer screening in the average-risk individual (Table 1). How can clinicians and policy makers use this information for decision making regarding colorectal cancer screening? The cost-effectiveness ratios reported by themselves do not identify cost-effective practices. They must be placed in a decision context that is expressed in one of two forms. In the first form, an explicit threshold or maximum amount that a policy maker is willing to spend is stated (e.g., $40,000 per LY gained, as has been quoted as an acceptable amount for a prevention program). In the second form of decision context, a list of medical practices and their associated cost-effectiveness ratios, also known as a league table (Table 2) is used as a basis for comparison with the practice under evaluation (e.g., colorectal cancer screening). The practice with the lowest cost-effectiveness ratio is the most cost-effective practice on the list. Practices with lower cost-effectiveness ratios are considered cost-effective compared with those with higher ratios. Table 2 lists incremental cost-effectiveness ratios for common medical practices. The models discussed in this article suggested that colorectal cancer screening using annual FOBT, flexible sigmoidoscopy at 3 or 5 years, the combination of FOBT and flexible sigmoidoscopy, barium enema, colonoscopy, and even virtual colonoscopy had incremental cost-effectiveness ratios ranging from $6300 to $92,900 per LY saved with most of the cost-effectiveness ratio ranging from $10,000 to $40,000 per LY saved. These ratios are similar to the cost of another widely accepted practice, breast cancer screening with annual mammography in women age 50 and older ($22,000 per LY gained). Colorectal cancer screening with any of the modalities discussed is considered less cost-effective than screening for hemochromatosis, which has an incremental cost-effectiveness ratio of $3665 per LY saved. Based on these ratios, however, screening for colorectal cancer is considered cost-effective compared with cervical cancer screening in women age 20 and older with pap smear every 3 years, which has an incremental cost-effectiveness ratio of $250,000 per LY gained. The clinician can use these incremental cost-effectiveness ratios to evaluate the risks and benefits of alternative practices for the individual, and the policy maker with a limited health care budget can use these ratios to set priorities for funding based on the costs and the expected gains in life expectancy for colorectal cancer screening and for alternative health care programs.