A unified framework for classification of methods for benefit-risk assessment.

BACKGROUND: Patients, physicians, and other decision makers make implicit but inevitable trade-offs among risks and benefits of treatments. Many methods have been proposed to promote transparent and rigorous benefit-risk analysis (BRA). OBJECTIVE: To propose a framework for classifying BRA methods on the basis of key factors that matter most for patients by using a common mathematical notation and compare their results using a hypothetical example. METHODS: We classified the available BRA methods into three categories: 1) unweighted metrics, which use only probabilities of benefits and risks; 2) metrics that incorporate preference weights and that account for the impact and duration of benefits and risks; and 3) metrics that incorporate weights based on decision makers' opinions. We used two hypothetical antiplatelet drugs (a and b) to compare the BRA methods within our proposed framework. RESULTS: Unweighted metrics include the number needed to treat and the number needed to harm. Metrics that incorporate preference weights include those that use maximum acceptable risk, those that use relative-value-adjusted life-years, and those that use quality-adjusted life-years. Metrics that use decision makers' weights include the multicriteria decision analysis, the benefit-less-risk analysis, Boers' 3 by 3 table, the Gail/NCI method, and the transparent uniform risk benefit overview. Most BRA methods can be derived as a special case of a generalized formula in which some are mathematically identical. Numerical comparison of methods highlights potential differences in BRA results and their interpretation. CONCLUSIONS: The proposed framework provides a unified, patient-centered approach to BRA methods classification based on the types of weights that are used across existing methods, a key differentiating feature.

Prospective Benefit-Risk Monitoring of New Drugs for Rapid Assessment of Net Favorability in Electronic Health Care Data.

BACKGROUND: Benefit-risk assessment (BRA) methods can combine measures of benefits and risks into a single value. OBJECTIVES: To examine BRA metrics for prospective monitoring of new drugs in electronic health care data. METHODS: Using two electronic health care databases, we emulated prospective monitoring of three drugs (rofecoxib vs. nonselective nonsteroidal anti-inflammatory drugs, prasugrel vs. clopidogrel, and denosumab vs. bisphosphonates) using a sequential propensity score-matched cohort design. We applied four BRA metrics: number needed to treat and number needed to harm; incremental net benefit (INB) with maximum acceptable risk; INB with relative-value-adjusted life-years; and INB with quality-adjusted life-years (QALYs). We determined whether and when the bootstrapped 99% confidence interval (CI) for each metric excluded zero, indicating net favorability of one drug over the other. RESULTS: For rofecoxib, all four metrics yielded a negative value, suggesting net favorability of nonselective nonsteroidal anti-inflammatory drugs over rofecoxib, and the 99% CI for all but the number needed to treat and number needed to harm excluded the null during follow-up. For prasugrel, only the 99% CI for INB-QALY excluded the null, but trends in values over time were similar across the four metrics, suggesting overall net favorability of prasugrel versus clopidogrel. The 99% CI for INB-relative-value-adjusted life-years and INB-QALY excluded the null in the denosumab example, suggesting net favorability of denosumab over bisphosphonates. CONCLUSIONS: Prospective benefit-risk monitoring can be used to determine net favorability of a new drug in electronic health care data. In three examples, existing BRA metrics produced qualitatively similar results but differed with respect to alert generation.

The reliability of medical group performance measurement in a single insurer's pay for performance program.

BACKGROUND: Most public reporting and pay for performance (P4P) programs in the United States continue to be organized and implemented by single insurers. Adequate medical group-level reliability on clinical care process measures is possible in multistakeholder initiatives because patient samples can be pooled across payers. However, the extent to which reliable measurement is achievable in single insurer P4P initiatives remains unclear. METHODS: This study uses 7 years (2001 to 2007) of patient-level clinical care process data from an insurer in Washington State involving 20 medical groups. Eight clinical care process measures were analyzed. We compared the medical group-level reliability and resulting sample size requirements for each of the 8 measures using unadjusted and adjusted binary mixed models. The relation of baseline intraclass correlation coefficients (ICCs) and medical group performance change over time was examined for each clinical care process measure. RESULTS: Only 45% of all medical group measurements (group-years for all observations) had sufficient sample sizes to achieve reliable estimates of group performance. Measures with the largest deficiencies in patient samples per group included appropriate asthma treatment and low-density lipoprotein screening for patients with coronary artery disease. There was an inconsistent relationship between the size of baseline ICCs and medical group performance improvement over time. CONCLUSIONS: Unreliable performance measurement is an important consequence of the prevailing organization and implementation of public reporting and P4P programs in the US. Multi-payer collaborations may be an important vehicle for ensuring reliable medical group performance measurement and comparisons on clinical care process measures.

Disclosure of genital human papillomavirus infection to female sex partners by young men.

A survey was administered to male university students who tested positive for high-risk human papillomavirus. Disclosure was more likely in men with fewer partners, in main partnerships, and in longer partnerships. Disclosure was associated with discussing the Pap test/human papillomavirus vaccine with female partners and not associated with a worsening relationship.

Associations between minimum wage policy and access to health care: evidence from the Behavioral Risk Factor Surveillance System, 1996-2007.

OBJECTIVES: We examined whether minimum wage policy is associated with access to medical care among low-skilled workers in the United States. METHODS: We used multilevel logistic regression to analyze a data set consisting of individual-level indicators of uninsurance and unmet medical need from the Behavioral Risk Factor Surveillance System and state-level ecological controls from the US Census, Bureau of Labor Statistics, and several other sources in all 50 states and the District of Columbia between 1996 and 2007. RESULTS: Higher state-level minimum wage rates were associated with significantly reduced odds of reporting unmet medical need after control for the ecological covariates, substate region fixed effects, and individual demographic and health characteristics (odds ratio = 0.853; 95% confidence interval = 0.750, 0.971). Minimum wage rates were not significantly associated with being uninsured. CONCLUSIONS: Higher minimum wages may be associated with a reduced likelihood of experiencing unmet medical need among low-skilled workers, and do not appear to be associated with uninsurance. These findings appear to refute the suggestion that minimum wage laws have detrimental effects on access to health care, as opponents of the policies have suggested.

Development of a survey to identify vaccine-hesitant parents: the parent attitudes about childhood vaccines survey.

OBJECTIVE: To develop a survey to accurately assess parental vaccine hesitancy. RESULTS: The initial survey contained 17 items in four content domains: (1) immunization behavior; (2) beliefs about vaccine safety and efficacy; (3) attitudes about vaccine mandates and exemptions; and (4) trust. Focus group data yielded an additional 10 survey items. Expert review of the survey resulted in the deletion of nine of 27 items and revisions to 11 of the remaining 18 survey items. Parent pretesting resulted in the deletion of one item, the addition of one item, the revision of four items, and formatting changes to enhance usability. The final survey contains 18 items in the original four content domains. METHODS: An iterative process was used to develop the survey. First, we reviewed previous studies and surveys on parental health beliefs regarding vaccination to develop content domains and draft initial survey items. Focus groups of parents and pediatricians generated additional themes and survey items. Six immunization experts reviewed the items in the resulting draft survey and ranked them on a 1-5 scale for significance in identifying vaccine-hesitant parents (5 indicative of a highly significant item). The lowest third of ranked items were dropped. The revised survey was pretested with 25 parents to assess face validity, usability and item understandability. CONCLUSIONS: The Parent Attitudes about Childhood Vaccines survey was constructed using qualitative methodology to identify vaccine-hesitant parents and has content and face validity. Further psychometric testing is needed.

Prescriber and staff perceptions of an electronic prescribing system in primary care: a qualitative assessment.

BACKGROUND: The United States (US) Health Information Technology for Economic and Clinical Health Act of 2009 has spurred adoption of electronic health records. The corresponding meaningful use criteria proposed by the Centers for Medicare and Medicaid Services mandates use of computerized provider order entry (CPOE) systems. Yet, adoption in the US and other Western countries is low and descriptions of successful implementations are primarily from the inpatient setting; less frequently the ambulatory setting. We describe prescriber and staff perceptions of implementation of a CPOE system for medications (electronic- or e-prescribing system) in the ambulatory setting. METHODS: Using a cross-sectional study design, we conducted eight focus groups at three primary care sites in an independent medical group. Each site represented a unique stage of e-prescribing implementation - pre/transition/post. We used a theoretically based, semi-structured questionnaire to elicit physician (n = 17) and staff (n = 53) perceptions of implementation of the e-prescribing system. We conducted a thematic analysis of focus group discussions using formal qualitative analytic techniques (i.e. deductive framework and grounded theory). Two coders independently coded to theoretical saturation and resolved discrepancies through discussions. RESULTS: Ten themes emerged that describe perceptions of e-prescribing implementation: 1) improved availability of clinical information resulted in prescribing efficiencies and more coordinated care; 2) improved documentation resulted in safer care; 3) efficiencies were gained by using fewer paper charts; 4) organizational support facilitated adoption; 5) transition required time; resulted in workload shift to staff; 6) hardware configurations and network stability were important in facilitating workflow; 7) e-prescribing was time-neutral or time-saving; 8) changes in patient interactions enhanced patient care but required education; 9) pharmacy communications were enhanced but required education; 10) positive attitudes facilitated adoption. CONCLUSIONS: Prescribers and staff worked through the transition to successfully adopt e-prescribing, and noted the benefits. Overall impressions were favorable. No one wished to return to paper-based prescribing.

Respiratory illnesses at the 2009 U.S. Army ROTC Advanced Camp.

Every summer the U.S. Army Reserve Officer Training Corps (ROTC) conducts the Leader Development Assessment Course (LDAC) for several thousand upcoming senior-year cadets. This study describes respiratory illnesses at 2009 ROTC LDAC after the emergence of the novel H1N1 influenza pandemic. This retrospective cohort study examines 5554 cadets and 1,616 cadres from 2009, and 5180 LDAC 2008 cadets. Respiratory clinic visits for 2009 cadets were higher than 2009 cadres and 2008 cadets, at 8.7, 2.0, and 4.2 visits per 1000 person-days available, respectively (p < 0.001). Further, respiratory illness hospitalizations and isolations were higher for 2009 cadets than cadres (p = 0.020). Although substantial efforts were made to prevent respiratory infections, there was considerable impact from respiratory illnesses, in the context of the novel H1N1 influenza pandemic, among 2009 ROTC LDAC participants. Our experience offers important lessons for future LDAC planning and for similar close quarters living circumstances.

Web-based collaborative care for type 1 diabetes: a pilot randomized trial.

BACKGROUND: To determine whether a Web-based diabetes case management program based in an electronic medical record can improve glycemic control (primary outcome) and diabetes-specific self-efficacy (secondary outcome) in adults with type 1 diabetes, a pilot randomized controlled trial was conducted. METHODS: A 12-month randomized trial tested a Web-based case management program in a diabetes specialty clinic. Patients 21-49 years old with type 1 diabetes receiving multiple daily injections with insulin glargine and rapid-acting analogs who had a recent A1C >7.0% were eligible for inclusion. Participants were randomized to receive either (1) usual care plus the nurse-practitioner-aided Web-based case management program (intervention) or (2) usual clinic care alone (control). We compared patients in the two study arms for changes in A1C and self-efficacy measured with the Diabetes Empowerment Scale. RESULTS: A total of 77 patients were recruited from the diabetes clinic and enrolled in the trial. The mean baseline A1C among study participants was 8.0%. We observed a nonsignificant decrease in average A1C (-0.48; 95% confidence interval -1.22 to 0.27; P = 0.160) in the intervention group compared to the usual care group. The intervention group had a significant increase in diabetes-related self-efficacy compared to usual care (group difference of 0.30; 95% confidence interval 0.01 to 0.59; P = 0.04). CONCLUSIONS: Use of a Web-based case management program was associated with a beneficial treatment effect on self-efficacy, but change in glycemic control did not reach statistical significance in this trial of patients with moderately poorly controlled type 1 diabetes. Larger studies may be necessary to further clarify the intervention's impact on health outcomes.

Discussion and revision of the mathematical modeling tool described in the previously published article "Modeling HIV Transmission risk among Mozambicans prior to their initiating highly active antiretroviral therapy".

Mathematical models are increasingly used in social and behavioral studies of HIV transmission; however, model structures must be chosen carefully to best answer the question at hand and conclusions must be interpreted cautiously. In Pearson et al. (2007), we presented a simple analytically tractable deterministic model to estimate the number of secondary HIV infections stemming from a population of HIV-positive Mozambicans and to evaluate how the estimate would change under different treatment and behavioral scenarios. In a subsequent application of the model with a different data set, we observed that the model produced an unduly conservative estimate of the number of new HIV-1 infections. In this brief report, our first aim is to describe a revision of the model to correct for this underestimation. Specifically, we recommend adjusting the population-level sexually transmitted infection (STI) parameters to be applicable to the individual-level model specification by accounting for the proportion of individuals uninfected with an STI. In applying the revised model to the original data, we noted an estimated 40 infections/1000 HIV-positive persons per year (versus the original 23 infections/1000 HIV-positive persons per year). In addition, the revised model estimated that highly active antiretroviral therapy (HAART) along with syphilis and herpes simplex virus type 2 (HSV-2) treatments combined could reduce HIV-1 transmission by 72% (versus 86% according to the original model). The second aim of this report is to discuss the advantages and disadvantages of mathematical models in the field and the implications of model interpretation. We caution that simple models should be used for heuristic purposes only. Since these models do not account for heterogeneity in the population and significantly simplify HIV transmission dynamics, they should be used to describe general characteristics of the epidemic and demonstrate the importance or sensitivity of parameters in the model.

Barriers and facilitators related to mammography use among lower educated Mexican women in the USA.

This study explores barriers to and facilitators of breast cancer screening and how people in a woman's social network influence these screening behaviors. A total of 40 semi-structured qualitative interviews were conducted in rural Washington State (USA) among Mexican women aged 50 and over. Eligible women reported either having had a mammogram within the last two years, over two years ago, or never. We found that lack of health insurance, the perception that the mammogram is painful, and fear of finding cancer were cited as barriers to participation in mammography screening. Women who had lived in the US for a shorter period were more likely to report never having had a mammogram than women who had lived in the US for a longer period. Women often cited daughters and female friends as those from whom they received advice or encouragement to receive a mammogram. Few differences were found related to network size and mammography use among the groups. These findings may be useful in designing interventions to promote mammography use. Including daughters in intervention activities may help facilitate mammography use among Mexican women.

Health services research doctoral core competencies.

This manuscript presents an initial description of doctoral level core competencies for health services research (HSR). The competencies were developed by a review of the literature, text analysis of institutional accreditation self-studies submitted to the Council on Education for Public Health, and a consensus conference of HSR educators from US educational institutions. The competencies are described in broad terms which reflect the unique expertise, interests, and preferred learning methods of academic HSR programs. This initial set of core competencies is published to generate further dialogue within and outside of the US about the most important learning objectives and methods for HSR training and to clarify the unique skills of HSR training program graduates.

Incidence and outcomes of acute lung injury.

BACKGROUND: Acute lung injury is a critical illness syndrome consisting of acute hypoxemic respiratory failure with bilateral pulmonary infiltrates that are not attributed to left atrial hypertension. Despite recent advances in our understanding of the mechanism and treatment of acute lung injury, its incidence and outcomes in the United States have been unclear. METHODS: We conducted a prospective, population-based, cohort study in 21 hospitals in and around King County, Washington, from April 1999 through July 2000, using a validated screening protocol to identify patients who met the consensus criteria for acute lung injury. RESULTS: A total of 1113 King County residents undergoing mechanical ventilation met the criteria for acute lung injury and were 15 years of age or older. On the basis of this figure, the crude incidence of acute lung injury was 78.9 per 100,000 person-years and the age-adjusted incidence was 86.2 per 100,000 person-years. The in-hospital mortality rate was 38.5 percent. The incidence of acute lung injury increased with age from 16 per 100,000 person-years for those 15 through 19 years of age to 306 per 100,000 person-years for those 75 through 84 years of age. Mortality increased with age from 24 percent for patients 15 through 19 years of age to 60 percent for patients 85 years of age or older (P<0.001). We estimate that each year in the United States there are 190,600 cases of acute lung injury, which are associated with 74,500 deaths and 3.6 million hospital days. CONCLUSIONS: Acute lung injury has a substantial impact on public health, with an incidence in the United States that is considerably higher than previous reports have suggested.

The causal effect of health insurance on utilization and outcomes in adults: a systematic review of US studies.

BACKGROUND: No current consensus exists on the causal effect of gaining or losing health insurance on health care utilization and health outcomes. OBJECTIVE: To systemically search and review available evidence of estimated causal effects of health insurance on health care utilization and/or health outcomes among nonelderly adults in the United States. RESEARCH DESIGN: A systematic search of 3 electronic databases (PubMed, JSTOR, EconLit) was performed. To be included in the review, studies had to have a publication date after 1991; a population of nonelderly adults; analyses comparing an uninsured group to an appropriate control group; and 1 of 3 study designs that account for potential reverse causality and provide estimates of causal effects (longitudinal cohort, instrumental variable analysis, or quasi-experimental design). RESULTS: A total of 9701 studies, including duplicates, were primarily screened. Fourteen studies fulfilled the criteria to be included in this review-4 longitudinal cohort studies using standard regression or fixed effects analysis, 5 longitudinal cohort studies using instrumental variable regression analysis, and 5 quasi-experimental studies. CONCLUSIONS: Results of our review of empirical studies that estimate causal relationships between health insurance and health care utilization and/or health outcomes consistently show that health insurance increases utilization and improves health. Specifically, health insurance had substantial effects on the use of physician services, preventive services, self-reported health status, and mortality conditional on injury and disease. These results both confirm and contradict comparable results from the RAND Health Insurance Experiment, the gold standard on relationships between health insurance, utilization, and health.

Providers' experience with an organizational redesign initiative to promote patient-centered access: a qualitative study.

BACKGROUND: Patient-centered access is a philosophy and a method that supports efforts to redesign health-care delivery systems to deliver higher quality care and to better meet the needs and preferences of patients. Since mid-2000, Group Health Cooperative has pursued an ensemble of strategic initiatives aimed at promoting patient-centered access, referred to as the Access Initiative. In support of this strategy, Group Health has also engaged in enterprise implementation of an electronic medical record and clinical information system that is integrated with their patient Web site, MyGroupHealth. OBJECTIVE: To elicit, describe, and characterize providers' perceptions of the effects of the Access Initiative, an information technology-enabled organizational redesign initiative intended to promote patient-centered access. DESIGN: Thematic analysis of semi-structured in-depth interviews. PARTICIPANTS: Twenty-two care providers representing 14 primary care, medical, and surgical specialties at Group Health Cooperative, an integrated health-care system based in Seattle, Washington. FINDINGS: Analyses of the interview transcripts revealed nine emergent themes, five of which have particular relevance for health-care organizations pursuing patient-centered access: the Access Initiative improved patient satisfaction, improved the quality of encounter-based care, compromised providers' focus on population health, created additional work for providers, and decreased job satisfaction for primary care providers and some medical specialists. CONCLUSIONS: Providers like that the Access Initiative is mostly good for their patients, but dislike the negative effects on their own quality of life - especially in primary care. These reforms may not be sustainable under current models of organization and financing.

Evaluation of the group health cooperative access initiative: study design challenges in estimating the impact of a large-scale organizational transformation.

The Institute of Medicine argues that poorly designed delivery systems are a major cause of low-quality care in the United States but does not present methods for evaluating whether its recommendations, when implemented by a health care organization, actually improve quality of care. We describe how time-series study designs using individual-level longitudinal data can be applied to address methodological challenges in our evaluation of the impact of the Group Health Cooperative "Access Initiative," an integrated set of 7 "patient-centered" reforms in its integrated delivery system that are consistent with the Institute of Medicine's recommendations. The methods may be generalizable to evaluating similar reforms in other integrated delivery systems with representative patient and physician data sources.

Severity of intimate partner violence and occurrence and frequency of police calls.

This article evaluates whether female victims of severe physical, psychological, or sexual intimate partner violence (IPV) call police more often than other abused women. Abused women (431) reported frequency of contacting police (dependent variable), nature and severity of IPV experienced, and characteristics of themselves and their perpetrator (explanatory variables). A two-part regression model estimated likelihood of police contact among all participants and rate of contact among callers. Women with severe physical or psychological IPV or injury were more likely to call police than were other abused women. Among callers, women made 96% more calls if a weapon was involved, 58% more if they were severely sexually abused, and 40% more if they were severely physically abused. Women with children at home made 32% more calls. These results delineate the level and types of IPV and other characteristics of homes that make single and repeat calls to police.

Ascertainment of intimate partner violence in women seeking legal protection.

BACKGROUND: Brief questions are necessary for identification of women seeking emergency professional services for intimate partner violence (IPV), and for initiating dialogue with women presenting for care who have previously reported abuse. We compare three questions that inquire about physical and psychological abuse to the Conflict Tactics Scale, version 2 (CTS-2) in a cohort of women seeking legal protection for IPV. METHODS: A total of 448 urban women reporting IPV to police or the court system completed surveys at 8 weeks (baseline), and 5 and 10 months after the incident to assess IPV. Sensitivity and specificity of brief questions on physical assault/abuse (one question) and psychological abuse (two questions) were assessed at baseline and in the periods between baseline and follow-up, using items from the CTS-2 reflecting minor and severe physical and psychological IPV as reference standards. RESULTS: Compared to the CTS-2 severe items, the physical abuse question at baseline detected 93% of abused women, and the two psychological abuse questions 94%. Sensitivity varied at follow-up (74% to 95% for physical, and 89% to 90% psychological), but remained higher when the severe versus minor CTS-2 items were reference standards. Specificity was reasonable for the physical question compared to the severe CTS-2 section (77% to 95%), but was more varied for the psychological questions (29% to 74%). CONCLUSIONS: Three brief questions reasonably identified women who experienced severe IPV and sought legal protection. The low specificity of the psychological questions suggests that women's abuse experience may not fit within the CTS-2 framework. The three questions should be considered for further testing in real-world settings as a tool for initiating conversation with women about abuse.

Managed care and patient-rated quality of care from primary physicians.

The aim is to determine the associations between managed care controls and patient-rated quality of care from primary physicians. In a prospective cohort study, 17,187 patients were screened in the waiting rooms of 261 primary care physicians in the Seattle metropolitan area (1996-1997) to identify 2,850 English-speaking adult patients with depressive symptoms and/or selected pain problems. Patients completed 6-month follow-ups to rate the quality of care from their primary physicians. The intensity of managed care was measured for each patient's health plan, primary care office, and physician. Regression analyses revealed that patients in more managed plans and offices had lower ratings of the quality of care from their primary physicians. Managed care controls targeting physicians were generally not associated with patient ratings.

Cost-consciousness among Swiss doctors: a cross-sectional survey.

BACKGROUND: Knowing what influences physicians attitudes toward health care costs is an important matter, because most health care expenditures are the results of doctors' decisions. Many decisions regarding medical tests and treatments are influenced by factors other than the expected benefit to the patient, including the doctor's demographic characteristics and concerns about cost and income. METHODS: Doctors (n = 1184) in Geneva, Switzerland, answered questions about their cost-consciousness, practice patterns (medical specialty, public.vs. private sector, number of patients per week, time spent with a new patient), work satisfaction, and stress from uncertainty. General linear models were used to identify independent risk factors of higher cost-consciousness. RESULTS: Most doctors agreed that trying to contain costs was their responsibility ("agree" or "totally agree": 90%) and that they should take a more prominent role in limiting the use of unnecessary tests (92%); most disagreed that doctors are too busy to worry about costs (69%) and that the cost of health care is only important if the patient has to pay for it out-of-pocket (88%). In multivariate analyses, cost-consciousness was higher among doctors in the public sector, those who saw fewer patients per week, who were most tolerant of uncertainty, and who were most satisfied with their work. CONCLUSION: Thus even in a setting with very high health care expenditures, doctors' stated cost-consciousness appeared to be generally high, even though it was not uniformly distributed among them.