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CONTEXT: Little is known about how the pharmaceutical industry responds to evidence of harm associated with its products, such as the publication in July 2002 of the Women's Health Initiative Estrogen Plus Progestin Trial (WHI E+P) report demonstrating that standard-dose Prempro produced significant harm and lacked net benefits.

OBJECTIVE: To examine pharmaceutical industry response to the WHI E+P results by analyzing promotional expenditures for hormone therapy before and after July 2002.

DESIGN AND SETTING: Nationally representative and prospectively collected longitudinal data (January 2001 through December 2003) on prescribing and promotion of hormone therapies were obtained from IMS Health and Consumer Media Reports.

MAIN OUTCOME MEASURES: Trends in quarterly prescriptions for hormone therapy and expenditures on 5 modes of drug promotion: samples, office-based detailing, hospital-based promotion, journal advertisements, and direct-to-consumer advertising.

RESULTS: Prior to the WHI E+P report, prescribing rates and promotional spending for hormone therapy were stable. In the quarter before the WHI E+P report (April-June 2002), 22.4 million prescriptions for hormone therapy were dispensed and $71 million was spent on promotion (in annual terms, $350 per year per US physician). Within 9 months of the report's publication (quarter 1 of 2003), there was a 32% decrease in hormone therapy prescriptions, and a nadir had been reached for promotional spending (37% decrease compared with pre-WHI E+P levels). Spending decreased for all promotional activities and most hormone therapies. Overall, the greatest declines were for samples (36% decrease as of quarter 1 of 2003) and direct-to-consumer advertising (100% decrease). The greatest declines in promotion occurred for standard-dose Prempro (61% decrease as of quarter 1 of 2003), the agent implicated by the WHI E+P report. More recently, promotional efforts have increased, particularly for lower-dose Prempro, a resurgence associated with modestly increased prescriptions for this newer agent.

CONCLUSIONS: Concordant with its widespread use, hormone therapy was among the most heavily promoted medications prior to the WHI E+P report. Following reporting of the evidence of harm from this trial, there was a substantial decline in promotional spending for hormone therapy, particularly for the agents most directly implicated in the trial. Interrelated with the impact of the trial results themselves and the ensuing media coverage, reduced promotion may have contributed to a substantial decline in hormone therapy prescriptions.

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Journal of the American Medical Association
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Randall S. Stafford
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Variation in use of health care is ubiquitous in the United States. It is attributable to exogenous differences in supply of medical resources; to identified and unidentified economic, social, and cultural factors; and to the idiosyncratic beliefs of physicians. It is perpetuated by the parochial character of much clinical practice. Patients in high-intensity areas do not appear to have better health outcomes: Much care is "flat of the curve." A more robust scientific foundation for clinical decisions could help to reduce variations, but major reform of health care financing is probably necessary to achieve substantial improvement in the organization and delivery of care.

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In 1999, the American College of Physicians (ACP), then the American College of Physicians-American Society of Internal Medicine, and the American College of Cardiology/American Heart Association (ACC/AHA) developed joint guidelines on the management of patients with chronic stable angina. The ACC/AHA then published an updated guideline in 2002, which ACP recognized as a scientifically valid review of the evidence and background paper. This ACP guideline summarizes the recommendations of the 2002 ACC/AHA updated guideline and underscores the recommendations most likely to be important to physicians seeing patients in the primary care setting. This guideline is the second of 2 that provide guidance on the management of patients with chronic stable angina. This document covers treatment and follow-up of symptomatic patients who have not had an acute myocardial infarction or revascularization procedure in the previous 6 months. Sections addressing asymptomatic patients are also included. Asymptomatic refers to patients with known or suspected coronary disease based on a history or electrocardiographic evidence of previous myocardial infarction, coronary angiography, or abnormal results on noninvasive tests. A previous guideline covered diagnosis and risk stratification for symptomatic patients who have not had an acute myocardial infarction or revascularization procedure in the previous 6 months and asymptomatic patients with known or suspected coronary disease based on a history or electrocardiographic evidence of previous myocardial infarction, coronary angiography, or abnormal results on noninvasive tests.

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Annals of Internal Medicine
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Douglas K. Owens
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BACKGROUND: Chronic angina carries an economic burden because of symptom management, the risk of major cardiovascular events, and lost productivity. The level of these costs has not been systematically quantified.

OBJECTIVE: This study sought to assemble best evidence on the economic burden of chronic angina, including both the direct costs of healthcare and the indirect costs of lost productivity.

METHODS: Studies published in English from January 1990 to June 2003 were located via electronic and manual searches and systematically reviewed. Eligible studies included those with information on cost of illness, cost of treatment, employment status, and/or work productivity and/or limitations for a population of patients with chronic angina.

RESULTS: Seventeen studies assessed the healthcare cost of managing chronic angina. Cost estimates varied widely because of differing patient populations, healthcare settings, countries of origin, and year(s) of data collection. The most critical determinant of healthcare costs appeared to be the use of revascularization procedures. Twenty studies reported work limitations, 5 of which quantified productivity loss in monetary terms. Interventions for chronic angina resulted in some improvement in employment and work limitations over the short term. However, the positive effect of revascularization procedures tended to erode over the long term (3 years and beyond) in a substantial number of patients.

CONCLUSIONS: Chronic angina carries substantial healthcare costs caused by frequent medical visits, medications, and expensive revascularization procedures. Workplace productivity loss because of angina is also substantial, but lasting long-term improvement in work status has been difficult to achieve.

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American Journal of Managed Care
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Mark A. Hlatky
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BACKGROUND: Research is limited regarding national patterns of behavioral counseling during ambulatory care. We examined time trends and independent correlates of diet and physical activity counseling for American adults with an elevated cardiovascular risk during their outpatient visits.

METHODS: The National Ambulatory Medical Care Survey (NAMCS) and National Hospital Ambulatory Medical Care Survey (NHAMCS) provided 1992-2000 national estimates of counseling practices in private physician offices and hospital outpatient departments.

RESULTS: Rates of diet and physical activity counseling among visits by at-risk adults exhibited a modest ascending trend from 1992 to 2000, with the biggest growth found between 1996 and 1997. Throughout the 1990s, however, diet counseling was provided in 45% and physical activity counseling in or = 30% of visits by adults with hyperlipidemia, hypertension, obesity, or diabetes mellitus. Lower likelihood of either counseling was significantly associated with patients who were > or = 75 years of age, seen by generalists, and those with fewer risk factors. Also, diet counseling was less frequently provided during visits by whites vs. ethnic minorities and by men vs. women.

CONCLUSIONS: Despite available national guidelines, diet and physical activity counseling remain below expectations during outpatient visits by adults with an elevated cardiovascular risk. Given recent trends, immediate, satisfactory improvement is unlikely without future innovative interventions.

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Preventive Medicine
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Randall S. Stafford
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This issue of CHP/PCOR's quarterly newsletter covers news and developments from the summer 2004 quarter. It features articles about:

  • a recently published study showing that the ATHENA decision-support system to improve hypertension care was used with relatively high frequency by physicians, and was viewed as helpful in their practice
  • CHP/PCOR core faculty member Paul Wise's assertions that children's health needs in the United States are not adequately addressed by current policies and programs
  • a study by CHP/PCOR trainee Mike Ong calculating the life-saving benefits of banning smoking in all U.S. workplaces
  • ongoing international research discussed at the 6th annual meeting of the Technological Change in Health Care (TECH) Global Research Network;
  • CHP/PCOR's sixth annual retreat, held in mid-September.
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    Information technology can support the implementation of clinical research findings in practice settings. Technology can address the quality gap in health care by providing automated decision support to clinicians that integrates guideline knowledge with electronic patient data to present real-time, patient-specific recommendations. However, technical success in implementing decision support systems may not translate directly into system use by clinicians. Successful technology integration into clinical work settings requires explicit attention to the organizational context. We describe the application of a "sociotechnical" approach to integration of ATHENA DSS, a decision support system for the treatment of hypertension, into geographically dispersed primary care clinics. We applied an iterative technical design in response to organizational input and obtained ongoing endorsements of the project by the organization's administrative and clinical leadership. Conscious attention to organizational context at the time of development, deployment, and maintenance of the system was associated with extensive clinician use of the system.

    COPYRIGHT RESTRICTION NOTICE:

    This material was originally published in the Journal of the American Medical Informatics Association (Volume 11; 368-376). This material may be read on-line or downloaded for personal use only. The material may be referenced by appropriate hyperlinks. However, the text of the material may not be altered without the express permission of the author and AMIA. Care should be taken when excerpting or referencing text to ensure that the views, opinions, and arguments of the author presented in the excerpt accurately reflect those contained in the original work.

    This grant does not extend to publication or posting of the paper to any website to which a fee or paid subscription is required to view or otherwise access the work.

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    Journal of the American Medical Informatics Association
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    Mary K. Goldstein
    Mark A. Musen
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    In early 2003, the Institute of Medicine (IOM) released its report, Priority Areas for National Action: Transforming Health Care Quality. The report listed 20 clinical topics for which "best practices" were strongly supported by clinical evidence. The rates at which these practices have been implemented in the United States has been disappointing low, at a cost of many thousands of lives each year.

    To bring data to bear on the quality improvement opportunities articulated in the IOM's 2003 report, the Agency for Healthcare Research and Quality (AHRQ) engaged the Stanford-UCSF Evidence-based Practice Center (EPC) to perform a critical analysis of the existing literature on quality improvement strategies for a selection of the 20 disease and practice priorities noted in the IOM Report. The focus of the commissioned investigations is translating research into practice -- identifying those activities that increase the rate with which practices known to be effective are applied to patient care in real world settings. In other words, the EPC research effort aims to facilitate narrowing the "quality gap" that is in large part responsible for suboptimal health care practices and outcomes. In addition to furthering the IOM's quality agenda, this analysis also has been prepared in support of the National Healthcare Quality Report (NHQR) (also see National Healthcare Disparities Report).

    In this, the first volume of Closing the Quality Gap, the authors introduce the series and its goal, while providing methodological and theoretical overviews for the quality improvement (QI) field of study. Subsequent volumes will address the relation of QI strategies to treatment practices for a number of the 20 priority areas identified in the IOM report.

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    Stanford-UCSF Evidence-based Practice Center, for the Agency for Healthcare Research and Quality
    Authors
    Douglas K. Owens
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    AHRQ Publication No. 04-0051-1; Contract No. 290-02-0017
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    Social trends and medical progress have fueled major changes in the epidemiology of child health in the United States. Injuries remain a major contributor to childhood illness and death. However, among noninjury causes, chronic illness now accounts for the majority of children's hospital days and deaths. Although mortality rates for all children have fallen dramatically, social disparities persist. Approximately half of all excess deaths among African-American children occur during infancy, primarily from extremely premature births, and the remaining portion, primarily from homicide and serious chronic conditions. These challenges may require changes in today's child health practices and policies.

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    Health Affairs
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    Paul H. Wise
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    OBJECTIVES: We examined consumers' search for information about health insurance choices and their use of the Internet for that search and to manage health benefits.

    STUDY DESIGN: We surveyed a random sample of more than 4500 individuals aged 21 years and older who were members of a survey research panel during December 2001 and January 2002.

    METHODS: The survey included questions about searching for health insurance information in 3 health insurance markets: Medicare, individual or nongroup, and employer-sponsored group. We also asked questions about use of the Internet to manage health benefits. We tabulated means of responses to each question by market and tested for independence across demographic groups using the Pearson chi-square test.

    RESULTS: We identified important differences across and within markets in the extent to which people look for information about health insurance alternatives and the role of the Internet in their search. Although many individuals were unaware of whether their employer or health plan provided a website to manage health benefits, those who used the sites generally evaluated them favorably.

    CONCLUSIONS: Our results suggest that the Internet is an important source of health insurance information, particularly for individuals purchasing coverage individually in the nongroup and Medicare markets relative to those obtaining coverage from an employer. In the case of Medicare coverage, studies focusing on beneficiaries' use of Internet resources may underestimate the Internet's importance by neglecting caregivers who use the Internet. Many individuals may be unaware of the valuable resources available through employers or health plans.

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    American Journal of Managed Care
    Authors
    Sara J. Singer
    Laurence C. Baker
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