Structural estimates of treatment effects on outcomes using retrospective data: an application to ductal carcinoma in situ.

Analysis of observational cohort data is subject to bias from unobservable risk selection. The authors compared econometric models and treatment effectiveness estimates using the linked Surveillance, Epidemiology, and End Results (SEER)-Medicare claims data for women diagnosed with ductal carcinoma in situ. Treatment effectiveness estimates for mastectomy and breast-conserving surgery (BCS) with or without radiotherapy were compared using three different models: simultaneous-equations model, discrete-time survival model with unobserved heterogeneity (frailty), and proportional hazards model. Overall trends in disease-free survival (DFS), or time to first subsequent breast event, by treatment are similar regardless of the model, with mastectomy yielding the highest DFS over 8 years of follow-up, followed by BCS with radiotherapy, and then BCS alone. Absolute rates and direction of bias varied substantially by treatment strategy. DFS was underestimated by single-equation and frailty models compared with the simultaneous-equations model and randomized controlled trial results for BCS with radiotherapy and overestimated for BCS alone.

Using the lessons of behavioral economics to design more effective pay-for-performance programs.

OBJECTIVES: To describe improvements in the design of pay-for-performance (P4P) programs that reflect the psychology of how people respond to incentives. STUDY DESIGN: Investigation of the behavioral economics literature. METHODS: We describe 7 ways to improve P4P program design in terms of frequency and types of incentive payments. After discussing why P4P incentives can have unintended adverse consequences, we outline potential ways to mitigate these. RESULTS: Although P4P incentives are increasingly popular, the healthcare literature shows that these have had minimal effect. Design improvements in P4P programs can enhance their effectiveness. CONCLUSION: Lessons from behavioral economics may greatly enhance the design and effectiveness of P4P programs in healthcare, but future work is needed to demonstrate this empirically.

Race and sex differences in the receipt of timely and appropriate lung cancer treatment.

BACKGROUND: Previous research suggests that disparities in non-small-cell lung cancer (NSCLC) survival can be explained in part by disparities in the receipt of cancer treatment. Few studies, however, have considered race and sex disparities in the timing and appropriateness of treatment across stages of diagnosis. OBJECTIVE: To evaluate the relationship of sex and race with the receipt of timely and clinically appropriate NSCLC treatment for each stage of diagnosis. METHOD: Surveillance Epidemiology and End Result data linked to Medicare claims for beneficiaries diagnosed with NSCLC between 1995 and 1999 were used to evaluate the relationship between race and sex with timely and appropriate NSCLC treatment while controlling for other demographic characteristics, comorbidities, socioeconomic status, and provider supply (N = 22,145). RESULTS: Overall adjusted rates of timely and appropriate treatment are 37.2%, 58.1%, and 29.2% for Medicare beneficiaries diagnosed with stage I or II, III, and IV NSCLC, respectively. Among stage I or II patients, women were 25% less likely to receive timely surgical resection relative to men, and blacks were 66% less likely to receive timely and appropriate treatment than whites. Black men were least likely to receive resection (22.2% compared with 43.7% for white men). Blacks were 34% less likely to receive timely surgery, chemotherapy, or radiation for stage III disease and were 51% less likely to receive chemotherapy in a timely fashion for stage IV disease relative to whites. CONCLUSION: Significant variations in appropriate timely treatment were found within and across stages of diagnosis, confirming that sex and race differences in NSCLC treatment exist.

The pen and the scalpel: effect of diffusion of information on nonclinical variations in surgical treatment.

BACKGROUND: As information is disseminated about best practices, variations in patterns of care should diminish over time. OBJECTIVE: To test the hypotheses that differences in rates of a surgical procedure are associated with type of insurance in an era of evolving practice guidelines and that insurance and site differences diminish with time as consensus guidelines disseminate among the medical community. METHODS: We use lymph node dissection among women with ductal carcinoma in situ (DCIS) as an example of a procedure with uncertain benefit. Using a sample of 1051 women diagnosed from 1985 through 2000 at 2 geographic sites, we collected detailed demographic, clinical, pathologic, and treatment information through abstraction of multiple medical records. We specified multivariate logistic models with flexible functions of time and time interactions with insurance and treatment site to test hypotheses. RESULTS: Lymph node dissection rates varied significantly according to site of treatment and insurance status after controlling for clinical, pathologic, treatment, and demographic characteristics. Rates of lymph node dissection decreased over time, and differences in lymph node dissection rates according to site and generosity of insurance were no longer significant by the end of the study period. CONCLUSIONS: We have demonstrated that rates of a discretionary surgical procedure differ according to nonclinical factors, such as treatment site and type of insurance, and that such unwarranted variation decreases over time with diminishing uncertainty and in an era of diffusion of clinical guidelines.

Diagnostic breast magnetic resonance imaging and contralateral prophylactic mastectomy.

BACKGROUND: Preoperative use of breast magnetic resonance imaging (MRI) in women with breast cancer may increase rates of mastectomy. This study investigated relationships between breast MRI and therapeutic and contralateral prophylactic mastectomy (CPM) in women with breast cancer. METHODS: A total of 3606 women diagnosed with stage 0-III breast cancer from 1998 through 2000 (n = 1743; early period) or from 2003 through 2005 (n = 1863; late period) were retrospectively identified. Patient demographic and clinical characteristics were obtained from our institution's tumor registry. MRI use in the diagnostic evaluation was obtained from a prospective radiology database. Rates of therapeutic mastectomy, CPM, and associations with breast MRI were compared between the two time periods by multiple logistic regressions controlling for disease stage, age, family history, and calendar year of diagnosis. RESULTS: A total of 14.2% of women underwent MRI, 29.0% had mastectomy, and 5.3% had CPM. Use of breast MRI increased substantially between the two time periods (4.1% to 23.7%, P < 0.001). Mastectomy rates increased from 28% to 30% (P > 0.05). The rate of CPM increased by >50% from the early to late period (4.1% to 6.4%, P < 0.002). Women who underwent MRI were nearly twice as likely to have CPM (9.2 vs. 4.7%, P < 0.001). Multivariate models found MRI was associated with increased rates of CPM for women with stage I or II disease (odds ratio 2.04, P = 0.001). CONCLUSIONS: MRI changes the surgical treatment of breast cancer among subsets of women diagnosed with breast cancer, suggesting there are hidden monetary and nonmonetary costs associated with its use.

Pay for performance in the hospital setting: what is the state of the evidence?

More than 40 private sector hospital pay-for-performance (P4P) programs now exist, and Congress is considering initiating a Medicare hospital P4P program. Given the growing interest in hospital P4P, this systematic review of the literature examines the current state of knowledge about the effect of P4P on clinical process measures, patient outcomes and experience, safety, and resource utilization. Little formal evaluation of hospital P4P has occurred, and most of the 8 published studies have methodological flaws. The most rigorous studies focus on clinical process measures and demonstrate that hospitals participating in the Centers for Medicare and Medicaid Services-Premier Hospital Quality Incentive Demonstration, a P4P program, had a 2- to 4-percentage point greater improvement than the improvement observed in control hospitals. There is a need for more systematic evaluation of hospital P4P to understand its effect and whether the benefits of investing in P4P outweigh the associated costs.

Assessment of contributions to patient safety knowledge by the Agency for Healthcare Research and Quality-funded patient safety projects.

OBJECTIVE: To characterize the activities of projects funded in Agency for Healthcare Research and Quality (AHRQ)'s patient safety portfolio and assess their aggregate potential to contribute to knowledge development. DATA SOURCES: Information abstracted from proposals for projects funded in AHRQ's patient safety portfolio, information on safety practices from the AHRQ Evidence Report on Patient Safety Practices, and products produced by the projects. STUDY DESIGN: This represented one part of the process evaluation conducted as part of a longitudinal evaluation based on the Context­Input­Process­Product model. PRINCIPAL FINDINGS: The 234 projects funded through AHRQ's patient safety portfolio examined a wide variety of patient safety issues and extended their work beyond the hospital setting to less studied parts of the health care system. Many of the projects implemented and tested practices for which the patient safety evidence report identified a need for additional evidence. The funded projects also generated a substantial body of new patient safety knowledge through a growing number of journal articles and other products. CONCLUSIONS: The projects funded in AHRQ's patient safety portfolio have the potential to make substantial contributions to the knowledge base on patient safety. The full value of this new knowledge remains to be confirmed through the synthesis of results

Experiences of Agency for Healthcare Research and Quality-funded projects that implemented practices for safer patient care.

OBJECTIVES: To synthesize lessons learned from the experiences of Agency for Healthcare Research and Quality-funded patient safety projects in implementing safe practices. DATA SOURCES: Self-reported data from individual and group interviews with Original, Challenge, and Partnerships in Implementing Patient Safety (PIPS) grantees, from 2003 to 2006. STUDY DESIGN: Interviews with three grantee groups (n=60 total) implementing safe practice projects, with comparisons on factors influencing project implementation and sustainability. DATA COLLECTION: Semi-structured protocols contained open-ended questions on lessons learned and more structured questions on factors associated with project implementation and sustainability. PRINCIPAL FINDINGS: The grantees shared common experiences, frequently identifying lessons learned regarding structural components needing to be in place before implementation, components of the implementation process, components of interventions' results needed for sustainability, changes in timelines or activities, unanticipated issues, and staff acceptance/adoption. Also, fewer Original grants had many of the factors related project to implementation/sustainability than the PIPS or Challenge grantees had. CONCLUSIONS: Although much of what was reported seemed like common sense, surprisingly few projects actually planned for or expected many of the barriers or facilitators they experienced during their project implementation. Others implementing practice improvements likely will share the experiences and issues identified by these implementation projects and can learn from their lessons.

Adopting information technology to drive improvements in patient safety: lessons from the Agency for Healthcare Research and Quality health information technology grantees.

OBJECTIVES: To document and assess the experiences of 104 Agency for Healthcare Research and Quality (AHRQ)-funded health information technology (health IT) grantees in planning and implementing health IT systems. DATA SOURCE: Grant proposals and interviews with the AHRQ health IT grantees. DATA COLLECTION METHOD: Extracted descriptive data from the health IT grant proposals; conducted telephone interviews with principal investigators. PRINCIPAL FINDINGS: AHRQ funding of the health IT projects provided important support for health IT development work in various health care settings. Successful implementation required commitment from top management, dedicated staff and financial resources, an open process to encourage buy-in and enthusiasm by end users, and sheer persistence. Technologies required tailoring to the specific organization's needs. Grantees felt their projects could be replicated by others, if organizations had ample IT expertise and resources. Evaluating the value of health IT was hampered by the absence of validated instruments and measures, organizational demands that competed with data collection, and lack of evaluation expertise among health IT implementers. CONCLUSIONS: Experiences of the health IT grantees provide rich information for use by health care providers, AHRQ, and other policy makers to help strengthen future health IT development efforts, including the need to improve evaluation design and standards to assess impact.

Training a patient safety work force: the patient safety improvement corps.

OBJECTIVE: Evaluate short-term effects of the Patient Safety Improvement Corps (PSIC), an Agency for Healthcare Research and Quality­sponsored program to train state teams in patient safety skills/tools, to assess its contribution to building a national infrastructure supporting effective patient safety practices. DATA SOURCE: Self-reported information gathered from (1) group interviews at the end of each year; (2) individual telephone interviews 1 year later; (3) faxed information forms 2 years later. STUDY DESIGN: Program evaluation of immediate and short-term process and impact (use of skills/tools, information sharing, changes in practice). DATA COLLECTION: Semistructured interviews; faxed forms. PRINCIPAL FINDINGS: One year after training, approximately half of Year 1 and 2 state agency representatives reported they had initiated or modified legislation to strengthen safe practices, and modified adverse event oversight procedures. Approximately three-quarters of hospital representatives said training contributed to modifications to adverse event oversight procedures and promotion of patient safety culture. Two years posttraining, approximately three-quarters of Year 1 trainees said they continued to use many skills/tools. CONCLUSIONS: The PSIC contributed to building a national infrastructure supporting effective patient safety practices. Expanded training is needed to reach a larger fraction of the population for which this training is important.

The growth of partnerships to support patient safety practice adoption.

OBJECTIVES: To document the numbers and types of interorganizational partnerships within the national patient safety domain, changes over time in these networks, and their potential for disseminating patient safety knowledge and practices. DATA SOURCES: Self-reported information gathered from representatives of national-level organizations active in promoting patient safety. STUDY DESIGN: Social network analysis was used to examine the structure and composition of partnership networks and changes between 2004 and 2006. DATA COLLECTION: Two rounds of structured telephone interviews (n=35 organizations in 2004 and 55 in 2006). PRINCIPAL FINDINGS: Patient safety partnerships expanded between 2004 and 2006. The average number of partnerships per interviewed organization increased 40 percent and activities per reported partnership increased over 50 percent. Partnerships increased in all activity domains, particularly dissemination and tools development. Fragmentation of the overall partnership network decreased and potential for information flow increased. Yet network centralization increased, suggesting vulnerability to partnership failure if key participants disengage. CONCLUSIONS: Growth in partnerships signifies growing strength in the capacity to disseminate and implement patient safety advancements in the U.S. health care system. The centrality of AHRQ in these networks of partnerships bodes well for its leadership role in disseminating information, tools, and practices generated by patient safety research projects.

An exploration of urban and rural differences in lung cancer survival among medicare beneficiaries.

OBJECTIVES: We tested the relationship between urban or rural residence as defined by rural-urban commuting area codes and risk of mortality in a sample of Medicare beneficiaries with lung cancer. METHODS: We used Surveillance, Epidemiology, and End Results data linked with Medicare claims to build proportional hazards models. The models tested hypothesized relationships between individual and community characteristics and overall survival for a cohort of Medicare beneficiaries 65 years and older who were diagnosed with lung cancer between 1995 and 1999 (N=26073). RESULTS: We found no evidence that lung cancer patients in rural areas have poorer survival than those in urban areas. Rather, individual (Medicaid coverage) and regional (lower census tract-level median income) socioeconomic factors and a smaller supply of subspecialists per 10000 individuals 65 years and older were positively associated with a higher risk of mortality. CONCLUSIONS: Although urban versus rural residence did not directly influence survival, rural residents were more likely to live in poorer areas with a smaller supply of health care providers. Therefore, we still need to be aware of rural beneficiaries' potential disadvantage when it comes to receiving needed care in a timely fashion.

Social and racial differences in selection of breast cancer adjuvant chemotherapy regimens.

PURPOSE: Breast cancer outcomes are worse among black women and women of lower socioeconomic status. The purpose of this study was to investigate racial and social differences in selection of breast cancer adjuvant chemotherapy regimens. METHODS: Detailed information on patient, disease, and treatment factors was collected prospectively on 957 patients who were receiving breast cancer adjuvant chemotherapy in 101 oncology practices throughout the United States. Adjuvant chemotherapy regimens included in any of several published guidelines were considered standard. Receipt of nonstandard regimens was examined according to clinical and nonclinical factors. Differences between groups were assessed using chi2 tests. Multivariate logistic regression was used to identify factors associated with use of nonstandard regimens. RESULTS: Black race (P = .008), lower educational attainment (P = .003), age 70 years (P = .001), higher stage (P < .0001), insurance type (P = .048), employment status (P = .045), employment type (P = .025), and geographic location (P = .021) were associated with the use of nonstandard regimens in univariate analyses. In multivariate analysis, black race (P = .020), lower educational attainment (P = .024), age > or = 70 years (P = .032), and higher stage (P < .0001) were associated with receipt of nonstandard regimens. CONCLUSION: The more frequent use of non-guideline-concordant adjuvant chemotherapy regimens in black women and women with lower educational attainment may contribute to less favorable outcomes in these populations. Addressing such differences in care may improve cancer outcomes in vulnerable populations.

Effect of patient socioeconomic status and body mass index on the quality of breast cancer adjuvant chemotherapy.

PURPOSE: The purpose of this study was to investigate the relationship between socioeconomic status (SES) and the use of intentionally reduced doses of chemotherapy in the adjuvant treatment of breast cancer. PATIENTS AND METHODS: Patients with breast cancer treated with a standard chemotherapy regimen (n = 764) were enrolled in a prospective registry after signing informed consent. Detailed information was collected on patient, disease, and treatment, including chemotherapy doses. Zip code level data on median household income, proportion of people living below the poverty level, and educational attainment were obtained from the US Census. Doses for the first cycle of chemotherapy lower than 85% of standard were considered to be reduced. Univariate analyses and multivariate logistic regression were performed to identify factors associated with the use of reduced first cycle doses. RESULTS: In univariate analysis, individual education attainment, zip code SES measures, body mass index, and geographic region were all significantly associated with receipt of intentionally reduced doses of chemotherapy. In multivariate analysis, controlling for geography, factors independently associated with reduced doses were obesity (odds ratio [OR], 2.47; 95% CI, 1.36 to 4.51), severe obesity (OR, 4.04; 95% CI, 1.46 to 11.19), and education less than high school (OR, 3.07; 95% CI, 1.57 to 5.99). CONCLUSION: Social disparities in breast cancer outcomes may be in part the result of lower quality chemotherapy doses in the adjuvant treatment of breast cancer. Efforts to address such prescribing patterns may help reduce SES disparities in breast cancer survival.

Vitality, mental health, and satisfaction with information after breast cancer.

OBJECTIVE: The purpose of this study was to investigate the relationship between satisfaction with information about treatment-related and survivorship issues and mental health outcomes, including vitality, in long-term breast cancer survivors. METHODS: Participants who had finished treatment for breast cancer at least 3 months before enrollment completed a survey instrument designed to evaluate satisfaction with diagnostic and treatment information and satisfaction with survivorship information. Mental health and vitality were measured using the Medical Outcomes Study SF-36, and distress was measured using the impact of events scale. Bivariate analyses and linear regression analyses were performed to investigate the relationships between satisfaction with information, mental health, vitality, and distress controlling for clinical and treatment variables. RESULTS: The survey was completed by 231 participants (response rate 83%). More respondents were highly satisfied with treatment information (87%) than with survivorship information (30%, p=0.0001). There was a strong positive relationship between satisfaction with information (both treatment and survivorship issues) and vitality, mental health, and a strong negative relationship with distress. In multivariate analyses, satisfaction with treatment information was independently associated with mental health (p<0.01), and satisfaction with survivorship information was independently associated with vitality (p<0.05). CONCLUSION: Among patients who have completed treatment for breast cancer, satisfaction with diagnosis and treatment information is greater than satisfaction with survivorship issues and satisfaction with information may play an important role in mental health outcomes. PRACTICE IMPLICATIONS: Given the relationship between satisfaction with information and vitality, interventions to improve informational support regarding survivorship issues are warranted.

Cost-effectiveness analysis of palivizumab in premature infants without chronic lung disease.

OBJECTIVES: To evaluate the cost-effectiveness of palivizumab as respiratory syncytial virus prophylaxis in premature infants without chronic lung disease and to evaluate the impact on cost-effectiveness of a potential reduction in risk of asthma following respiratory syncytial virus infection among infants receiving palivizumab. DESIGN: Two decision analytic models were designed, one with and the other without accounting for increased risk of asthma following respiratory syncytial virus infection. SETTING: A hypothetical community or university hospital. PARTICIPANTS: Hypothetical cohorts of infants without chronic lung disease born at 26 to 32 weeks' gestation. INTERVENTIONS: Palivizumab prophylaxis vs no prophylaxis. MAIN OUTCOME MEASURES: Expected costs and incremental cost-effectiveness ratio expressed as cost per quality-adjusted life-year. RESULTS: The expected costs were higher for palivizumab prophylaxis as compared with no prophylaxis. The incremental cost-effectiveness ratios were high for all gestations and are not considered cost-effective by today's standards (<$200 000 per quality-adjusted life-year). Both models were sensitive to variation in the cost of palivizumab. The model that included asthma was sensitive to variation in quality of life for children with asthma. In instances where asthma was considered severe with profound worsening in quality of life compared with life without asthma, some infants had an incremental cost per quality-adjusted life-year that was less than $200 000. CONCLUSIONS: Our model supports implementing more restrictive guidelines for palivizumab prophylaxis. Palivizumab was cost-effective for some infants in an analysis that accounted for increased risk of severe asthma following respiratory syncytial virus infection.

Undertreatment of obese women receiving breast cancer chemotherapy.

BACKGROUND: Systematic undertreatment of breast cancer in overweight and obese women may contribute to the poorer prognosis in these women. The objective of this study was to investigate treatment patterns in overweight and obese women undergoing breast cancer adjuvant chemotherapy. METHODS: We performed a retrospective cohort study of 9672 women treated with doxorubicin hydrochloride and cyclophosphamide between 1990 and 2001. The main outcome measure was the quality of chemotherapy as measured by the use of reduced doses for the first treatment (compared with standard doses), the overall dose proportion (actual-expected dose ratio), and relative dose intensity. RESULTS: First-cycle dose reductions (defined as a dose proportion of <0.9 compared with standard published doses) were administered to 9% of the healthy weight, 11% of the overweight, 20% of the obese, and 37% of the severely obese women (P<.001). First-cycle reduction was independently associated with being overweight (P = .03), obese (P<.001), severely obese (P<.001), older than 60 years (P<.001), and having a serious comorbid condition (P = .03). Practices varied greatly in the use of dose reductions in overweight and obese patients. Severe obesity was independently associated with a lower likelihood of admission for febrile neutropenia, even among those subjects given full weight-based doses (odds ratio, 0.61; 95% confidence interval, 0.38-0.97). CONCLUSIONS: Overweight and obese women with breast cancer often receive intentionally reduced doses of adjuvant chemotherapy. Administration of initial and overall full weight-based doses of adjuvant chemotherapy in overweight and obese women is likely to improve outcomes in this group of patients.

Racial disparity in the dose and dose intensity of breast cancer adjuvant chemotherapy.

PURPOSE: The purpose of this study was to investigate the impact of race and obesity on dose and dose intensity of adjuvant chemotherapy. METHODS: We abstracted data on patient/tumor characteristics, treatment course, physicians' intention to give a first cycle dose reduction, and reasons for dose reductions/delays from oncology records of 489 women treated from 1985 to 1997 in 10 treatment sites in two geographical regions. Administered doses and dose intensity were compared to standard regimens. Multivariate regression models determined the impact of race and body mass index (BMI) on dose proportion (actual:expected doses) and relative dose intensity (RDI) controlling for patient characteristics, comorbidity, chemotherapy regimen, site, and year of treatment. Logistic regressions explored race and BMI versus use of first cycle dose reductions. RESULTS: African-Americans received lower chemotherapy dose proportion and RDI than whites (0.80 vs. 0.85, p = 0.03 and 0.76 vs. 0.80, p = 0.01). In multivariate analyses, dose proportion was 0.09 lower (p = 0.002), and RDI was 0.10 (p < 0.001) lower in non-overweight African-Americans than whites. Obesity was associated with lower dose proportion (p < 0.01) and RDI (p < 0.03). Race and BMI were independently associated with first cycle dose reductions. Non-overweight African-Americans (p < 0.05) and overweight and obese African-American and white women (p < 0.001) were more likely to have first cycle dose reductions than non-overweight whites. CONCLUSION: We identified systematic differences in the administration of chemotherapy given to African-Americans and to overweight and obese women. These differences may contribute to documented disparities in outcome.

The effect of capitation on switching primary care physicians.

OBJECTIVE: To examine the relationship between patient case-mix, utilization, primary care physician (PCP) payment method, and the probability that patients switch their PCPs. DATA SOURCES/STUDY SETTING: Administrative enrollment and claims/encounter data for 1994-1995 from four physician organizations. STUDY DESIGN: We developed a conceptual model of patient switching behavior, which we used to guide the specification of multivariate logistic analyses focusing on interactions between patient case-mix, utilization, and PCP reimbursement methods. DATA COLLECTION/EXTRACTION METHODS: Claims data were aggregated to the encounter level; a switch was defined as a change in PCP since the previous encounter. The PCPs were reimbursed on either a capitated or fee-for-service (FFS) basis. PRINCIPAL FINDINGS: Patients with stable chronic conditions (Ambulatory Diagnostic Groups [ADG] 10) and capitated PCPs were 36 percent more likely to switch PCPs than similar patients with FFS PCPs, controlling for patient age and sex and physician fixed effects. When the number of previous encounters was included in the model this relationship was no longer significant. Instead high utilizers with capitated PCPs were significantly more likely to switch PCPs than were similar patients with FFS PCPs. CONCLUSIONS: A patient's demographics and utilization are associated with the probability that the patient will switch PCPs. Capitated PCP payment was associated with higher rates of switching among high utilizers of health care resources. These findings raise concerns about the continuity and quality of care experienced by vulnerable patients in an era of changing financial incentives.