Jennifer Elston Lafata

Where Is the Evidence? A Systematic Review of Shared Decision Making and Patient Outcomes:

Background. Despite widespread advocacy for shared decision making (SDM), the empirical evidence regarding its effectiveness to improve patient outcomes has not been systematically reviewed. The purpose of this study was to systematically review the empirical evidence linking patient outcomes and SDM, when the decision-making process has been explicitly measured, and to identify under what measurement perspectives SDM is associated with which types of patient outcomes (affective-cognitive, behavioral, and health). Data Sources. PubMed (through December 2012) and hand search of article bibliographies. Study Selection. Studies were included if they empirically 1) measured SDM in the context of a patient-clinician interaction and 2) evaluated the relationship between SDM and at least 1 patient outcome. Data Extraction. Study results were categorized by SDM measurement perspective (patient-reported, clinician-reported, or observer-rated) and outcome type (affective-cognitive, behavioral, or health). Data Synthesis. Thirty-nine studies met inclusion criteria. Thirty-three used patient-reported measures of SDM, 6 used observer-rated measures, and 2 used clinician-reported measures. Ninety-seven unique patient outcomes were assessed; 51% affective-cognitive, 28% behavioral, and 21% health. Only 43% of assessments (n = 42) found a significant and positive relationship between SDM and the patient outcome. This proportion varied by SDM measurement perspective and outcome category. It was found that 52% of outcomes assessed with patient-reported SDM were significant and positive, compared with 21% with observer-rated and 0% with clinician-reported SDM. Regardless of measurement perspective, SDM was most likely to be associated with affective-cognitive patient outcomes (54%), compared with 37% of behavioral and 25% of health outcomes. Limitations. The relatively small number of studies precludes meta-analysis. Because the study inclusion and exclusion criteria required both an empirical measure of SDM and an assessment of the association between that measure and a patient outcome, most included studies were observational in design. Conclusions. SDM, when perceived by patients as occurring, tends to result in improved affective-cognitive outcomes. Evidence is lacking for the association between empirical measures of SDM and patient behavioral and health outcomes.

Potentially Inappropriate Medication Use by Elderly Persons in U.S. Health Maintenance Organizations, 2000–2001

Objectives: To determine rates of potentially inappropriate medication use in elderly persons in managed care plans in the United States in 2000–2001.

The cost-effectiveness of different management strategies for patients on chronic warfarin therapy

OBJECTIVE: To examine the cost-effectiveness of moving from usual care to more organized management strategies for patients on chronic warfarin therapy.DESIGN: Using information available in the scientific literature, supplemented with data from a large health system and, when necessary, expert opinion, we constructed a 5-year Markov model to evaluate the health and economic outcomes associated with each of three different anticoagulation management approaches: usual care, anticoagulation clinic testing with a capillary monitor, and patient self-testing with a capillary monitor.PATIENTS: Three hypothetical cohorts of patients beginning long-term warfarin therapy were used to generate model results.MAIN RESULTS: Model results indicated that moving from usual care to anticoagulation clinic testing would result in a total of 1.7 thromboembolic events and 2.0 hemorrhagic events avoided per 100 patients over 5 years. Another 4.0 thromboembolic events and 0.8 hemorrhagic events would be avoided by moving to patient self-testing. When direct medical care costs and those incurred by patients and their caregivers in receiving care were considered, patient self-testing was the most cost-effective alternative, resulting in an overall cost saving.CONCLUSIONS: Results illustrate the potential health and economic benefits of organized care management approaches and capillary monitors in the management of patients receiving warfarin therapy.

Estimation of the period prevalence of inflammatory bowel disease among nine health plans using computerized diagnoses and outpatient pharmacy dispensings

Background: There are few contemporary estimates of prevalence rates for inflammatory bowel disease (IBD) in diverse North American communities. Methods: We estimated the period prevalence of IBD for January 1, 1999, through June 30, 2001, among 1.8 million randomly sampled members of nine integrated healthcare organizations in the US using computerized diagnoses and outpatient pharmaceutical dispensing. We also assessed the positive predictive value (PPV) and sensitivities of 1) the case‐finding algorithm, and 2) the 30‐month sampling period using medical chart review and linkage to a 78‐month dataset, respectively. Results: The PPV of the case‐finding algorithm was 81% (95% confidence interval [CI], 78–87) and 84% (95% CI, 79–89) in two different organizations. In both, the sensitivity of the optimal algorithm, compared with the most inclusive, exceeded 90%. The sensitivity of the 30‐month sampling period compared with 78 months was 61% (95% CI, 57–64) in one organization. Applying a slightly more sensitive case‐finding algorithm, the average period prevalence of IBD across the nine organizations, standardized to the age‐ and gender‐distribution of the US population, 2000 census, was 388 cases (95% CI, 378–397) per 100,000 persons (range 209–784 per 100,000; average follow‐up 26 months). The prevalence of Crohns disease, ulcerative colitis, and unspecified IBD was 129, 191, and 69 per 100,000, respectively. Conclusions: The observed average prevalence was similar to prevalence proportions reported for other North American populations (369–408 per 100,000). Additional research is needed to understand differences in the occurrence of IBD among diverse populations as well as practice variation in diagnosis and treatment of IBD.

Sociodemographic differences in the receipt of colorectal cancer surveillance care following treatment with curative intent.

Background.Despite limited evidence of its effectiveness, most guidelines recommend colorectal cancer survivors undergo posttreatment surveillance care. This article describes the posttreatment use of colon e-aminations, carcinoembryonic antigen (CEA) testing, and metastatic disease testing among a managed care population. Methods.Two hundred fifty-one patients with colorectal cancer enrolled in a managed care organization at diagnosis (1/1/90–12/31/95) and treated with curative intent. Patients were identified via a Cancer Registry maintained by a large group practice. Cumulative incidences of service receipt were estimated using actuarial (Kaplan-Meier) survival analyses. Co- Proportional Hazard Models were used to evaluate the relation of patient sociodemographic and clinical characteristics to service receipt. Average 8-year medical care e-penditures were calculated. Results.Within 18 months of treatment, 55% of the cohort received a colon examination, 71% received CEA testing, and 59% received metastatic disease testing. Whites were more likely than minorities to receive CEA testing (RR = 1.47, P = 0.04) and tended to be more likely to receive a colon examination (RR = 1.43, P = 0.09). As the median household income of a patient’s zip code of residence increased, so too did the likelihood of colon examination and metastatic disease testing receipt (RR = 1.09, P = 0.03 and RR = 1.12, P <0.01, respectively). Average 8-year medical care expenditures among the cohort were

Innovative strategies using SUDAAN for analysis of health surveys with complex samples

30,247. Conclusions.Among a population with financial access to care, differences were found in the receipt of colorectal cancer surveillance care by race and income. Additional investigations are needed to understand why minorities and those residing in low-income areas are less likely to receive surveillance care.

The Use of QALYs in Clinical and Patient Decision-Making: Issues and Prospects

Large-scale health surveys provide a wealth of information for addressing problems in health sciences research. Designed for multiple purposes, these surveys frequently have large sample sizes and extensive measurements of demographic and socioeconomic characteristics, risk factors, disease outcomes and health care service use and costs. Complex features of the sampling design typically employed to select the survey sample, coupled with the vast amount of information available from the survey database, underlie issues that must be addressed during data processing and analysis. Numerous articles in the literature have focused on the debate of whether or not, and how, to control for features of the sample design during data analysis. Traditional statistical methods for simple random samples and the software that accompanies them have historically not had the capacity to account for the survey design. Recent advancements in statistical methodology for survey data analysis have greatly expanded the analytical tools available to the survey analyst. Commercial software packages that incorporate these methods offer the analyst convenient ways for applying such tools to large survey databases in an easy and efficient manner. We present an overview of analysis strategies for survey data and illustrate their application via the SUDAAN software system. Examples for analyses are provided through data from two large US health surveys, the National Health Interview Survey and the Longitudinal Study of Aging. Questions of both a cross-sectional and longitudinal nature are addressed. The examples involve logistic regression, time-to- event analysis, and repeated measures analysis.

Routine surveillance care after cancer treatment with curative intent.

Decision-makers utilize the results of economic analysis in a wide range of settings that include governmental agencies, managed care, and other health-care payers [1,2]. A cornerstone of such analysis is the quality-adjusted life-year (QALY), which is formed by the arithmetic product of quantity and quality of life. The expansion in use of economic evaluation by health agencies has mirrored the growing recognition of the usefulness of healthrelated quality of life (HrQoL) as an important indicator of outcome of disease treatment among clinicians and patients [3–7]. This information has a dual use in that it informs both clinicians and health economists in the evaluation of treatment options. The use of the QALY as a health outcome measure for groups of patients is fairly clear for payers, managed care, and governmental organizations who seek to make decisions that maximize the value of health-care spending in terms of health outcomes achieved through the most efficient use of limited resources. Nevertheless, the importance and need to bring QALYs into the wider decision-making process of clinicians and patients is more controversial. For the purposes of this article, it is assumed that economic evaluation of health-care interventions by national reimbursement or other health-care decision-making bodies is largely a given, although there clearly are health-care jurisdictions in which this is not the case. Nevertheless, in a global marketplace, the requirements of dominant health-care jurisdictions are likely to influence the behaviors of other stakeholders across the world community. Hence, the influential role of cost-utility analysis (CUA) as part of an information toolkit for high-level decisionmaking is unlikely to be radically altered in the next 5 to 10 years. Central to CUA is the need for an outcome measure that combines the effects of health interventions on mortality and morbidity into a single index—the QALY. Critical to the computation of QALYs is the assessment of the impact of morbidity, represented through the measurement of HrQoL from data gathered in clinical trials and observational studies. Although these same data are applied in the economic evaluation of new health technologies, they may also be used in other non-economic applications, for example, in monitoring health status in individual patients, or in measuring population health or the impact of therapies in clinical studies. Different health jurisdictions permit or require different forms of HrQoL measurement in the economic evaluation of health technologies. Some stipulate that the weights used to value HrQoL states are social preferences that reflect the views of the general population. Others are open to the use of values derived from patients or others directly affected by the health technology. The question as to whose values do (or should) count is a matter for local arbitration within the decision-making framework of specific societies and their individual health-care systems. Ultimately, it is a political choice. It is not (and should not be) determined by health economists or other single stakeholder groups. For the purposes of this article, it is sufficient to note that the quality-adjustment factor used in computing QALYs can emanate from several sources and may or may not represent the views of the patient or those who care for them. It is worth briefly reflecting on both “decision-maker” as an attribute of an individual or set of individuals and “decisionmaking” as an activity undertaken by members of that set. Highlevel policy that shapes the development of health-care programs is clearly distinct from the day-to-day delivery of care to patients. Decision-making activity in support of the former is more likely to make use of economic evaluation than is the case in the latter. Policy formation is informed to some extent by aggregated measures of costs and benefits. Individual clinicians may contribute to those data but more often are faced with decisions that are made in relative ignorance of the wider societal-level picture. A decision by a clinician to admit a patient to hospital for treatment, or to provide innovative therapy or embark on diagnostic investigations is likely to be taken with minimal reference to the evidence of any economic evaluation (should it exist). Conversely, health programs are more likely to be formulated with regard for evidence of effectiveness and cost-effectiveness of such interventions when applied to population subgroups, occasionally to whole populations. This article addresses a number of related issues that stem from a more widely drawn interpretation of the QALY in which its status as a composite measure of health benefit is recognized, but where its role is not wholly contained within or limited to a cost-effectiveness framework. Under what circumstances is QALY-based information of value to decision-makers such as clinicians and other staff with direct responsibility for patient care? Is the QALY in its present format useful for the comparison of health outcomes within a given therapeutic area? How might the value to clinicians and patients of QALY-based information and its application in low-level decision-making be enhanced? And finally, what obstacles need to be overcome in extending the uses and usefulness of the QALY to noneconomist health-care decision-makers?

Construction of a Multisite DataLink Using Electronic Health Records for the Identification, Surveillance, Prevention, and Management of Diabetes Mellitus: The SUPREME-DM Project

Background:Many consensus guidelines recommend routine surveillance to detect recurrent disease among cancer survivors. We compare surveillance care receipt to guideline recommendations. Methods:Cohorts of patients aged 30 years or older diagnosed with breast, colorectal, endometrial, lung, or prostate cancer between 1990 and 1995 and treated with curative intent were identified (n = 100 per site). Receipt and indications for examinations and procedures were abstracted from medical records for as long as 5 years after treatment. Kaplan-Meier product estimates were used to estimate time to initial and subsequent service receipt. Results:Most cancer patients received the recommended minimum number of physical examinations after treatment. In fact, a sizable number of cancer survivors received physical examinations at a frequency in excess of what is currently recommended. Similarly, most of these cancer survivors received recommended testing for local recurrence. Yet, less than two thirds of colorectal cancer patients received recommended colon examinations in the initial year after treatment. Among colorectal, lung, and prostate cancer patients who received recommended initial local recurrence testing, repeat testing tended to occur more frequently than what is currently recommended. The use of testing for metastatic disease that is not recommended in guidelines is also commonplace among these cancer survivors. Conclusions:Among cohorts of cancer patients, we found wide variation in the use of surveillance care, including patterns of care receipt reflective of both underuse and overuse relative to guideline recommendations. Clinical reasons for these variations and the cost and health implications deserve further study.

Laboratory monitoring of drugs at initiation of therapy in ambulatory care.

Introduction Electronic health record (EHR) data enhance opportunities for conducting surveillance of diabetes. The objective of this study was to identify the number of people with diabetes from a diabetes DataLink developed as part of the SUPREME-DM (SUrveillance, PREvention, and ManagEment of Diabetes Mellitus) project, a consortium of 11 integrated health systems that use comprehensive EHR data for research. Methods We identified all members of 11 health care systems who had any enrollment from January 2005 through December 2009. For these members, we searched inpatient and outpatient diagnosis codes, laboratory test results, and pharmaceutical dispensings from January 2000 through December 2009 to create indicator variables that could potentially identify a person with diabetes. Using this information, we estimated the number of people with diabetes and among them, the number of incident cases, defined as indication of diabetes after at least 2 years of continuous health system enrollment. Results The 11 health systems contributed 15,765,529 unique members, of whom 1,085,947 (6.9%) met 1 or more study criteria for diabetes. The nonstandardized proportion meeting study criteria for diabetes ranged from 4.2% to 12.4% across sites. Most members with diabetes (88%) met multiple criteria. Of the members with diabetes, 428,349 (39.4%) were incident cases. Conclusion The SUPREME-DM DataLink is a unique resource that provides an opportunity to conduct comparative effectiveness research, epidemiologic surveillance including longitudinal analyses, and population-based care management studies of people with diabetes. It also provides a useful data source for pragmatic clinical trials of prevention or treatment interventions.