A methodological framework for model selection in interrupted time series studies.

Interrupted time series (ITS) is a powerful and increasingly popular design for evaluating public health and health service interventions. The design involves analyzing trends in the outcome of interest and estimating the change in trend following an intervention relative to the counterfactual (the expected ongoing trend if the intervention had not occurred). There are two key components to modeling this effect: first, defining the counterfactual; second, defining the type of effect that the intervention is expected to have on the outcome, known as the impact model. The counterfactual is defined by extrapolating the underlying trends observed before the intervention to the postintervention period. In doing this, authors must consider the preintervention period that will be included, any time-varying confounders, whether trends may vary within different subgroups of the population and whether trends are linear or nonlinear. Defining the impact model involves specifying the parameters that model the intervention, including for instance whether to allow for an abrupt level change or a gradual slope change, whether to allow for a lag before any effect on the outcome, whether to allow a transition period during which the intervention is being implemented, and whether a ceiling or floor effect might be expected. Inappropriate model specification can bias the results of an ITS analysis and using a model that is not closely tailored to the intervention or testing multiple models increases the risk of false positives being detected. It is important that authors use substantive knowledge to customize their ITS model a priori to the intervention and outcome under study. Where there is uncertainty in model specification, authors should consider using separate data sources to define the intervention, running limited sensitivity analyses or undertaking initial exploratory studies.

Controlled trial of interventions to increase testing and treatment for Helicobacter pylori and reduce medication use in patients with chronic acid-related symptoms.

BACKGROUND: Many symptomatic patients take proton pump inhibitors or histamine-2 blockers for years and those without gastro-oesophageal reflux disease might benefit from Helicobacter pylori eradication. AIM: To increase testing and treatment of H. pylori and reduce chronic use of proton pump inhibitors and histamine-2 blockers. METHODS: We conducted a three-armed controlled trial in 14 managed care practices. We included adults who used proton pump inhibitors or histamine-2 blockers for >1 year and excluded those with gastro-oesophageal reflux disease or previous endoscopy. We compared usual care (n = 312 patients from 6 practices) to low-intensity (n = 147 from 3 practices) and high-intensity (n = 122 from 5 practices) interventions. Low-intensity intervention consisted of guidelines, patient-lists, and a "toolkit"; high-intensity intervention added academic group detailing by a gastroenterologist with reinforcement by pharmacists. RESULTS: Compared with usual care, the high-intensity intervention increased H. pylori test-ordering (29% versus 9% at 12 months, P = 0.02). About half (23 of 58) of patients tested positive and 22 received eradication treatments. The high-intensity intervention decreased proton pump inhibitor use by 9% per year (P = 0.028), but did not alter histamine-2 blocker use. The low intensity intervention was ineffective. CONCLUSIONS: Providing guidelines, patient-lists, and toolkits was no better than usual care. Adding group detailing and pharmacist reinforcements led to improvements in H. pylori management and decreases in proton pump inhibitor use.

Segmented regression analysis of interrupted time series studies in medication use research.

Interrupted time series design is the strongest, quasi-experimental approach for evaluating longitudinal effects of interventions. Segmented regression analysis is a powerful statistical method for estimating intervention effects in interrupted time series studies. In this paper, we show how segmented regression analysis can be used to evaluate policy and educational interventions intended to improve the quality of medication use and/or contain costs.

Measuring access to effective care among elderly medicare enrollees in managed and Fee-for-Service care: a retrospective cohort study.

BACKGROUND: Our aim was to compare access to effective care among elderly Medicare patients in a Staff Model and Group Model HMO and in Fee-for-Service (FFS) care. METHODS: We used a retrospective cohort study design, using claims and automated medical record data to compare achievement on quality indicators for elderly Medicare recipients. Secondary data were collected from 1) HMO data sets and 2) Medicare claims files for the time period 1994-95. All subjects were Medicare enrollees in a defined area of New England: those enrolled in two divisions of a managed care plan with different physician payment arrangements: a staff model, and a group model; and the Medicare FFS population. We abstracted information on indicators covering several domains: preventive, diagnosis-specific, and chronic disease care. RESULTS: On the indicators we created and tested, access in the single managed care plan under study was comparable to or better than FFS care in the same geographic region. Percent of Medicare recipients with breast cancer screening was 36 percentage points higher in the staff model versus FFS (95% confidence interval 34-38 percentage points). Follow up after hospitalization for myocardial infarction was 20 percentage points higher in the group model than in FFS (95% confidence interval 14-26 percentage points). CONCLUSION: According to indicators developed for use in both claims and automated medical record data, access to care for elderly Medicare beneficiaries in one large managed care organization was as good as or better than that in FFS care in the same geographic area.

Supplemental insurance and use of effective cardiovascular drugs among elderly medicare beneficiaries with coronary heart disease.

CONTEXT: Cost-sharing in US prescription drug coverage plans for elderly persons varies widely. Evaluation of prescription drug use among elderly persons by type of health insurance could provide useful information for designing a Medicare drug program. OBJECTIVE: To determine use of effective cardiovascular drugs among elderly persons with coronary heart disease (CHD) by type of health insurance. DESIGN, SETTING, AND PATIENTS: Cross-sectional evaluation of 1908 community-dwelling adults, aged 66 years or older, with a history of CHD or myocardial infarction from the 1997 Medicare Current Beneficiary Survey, a nationally representative sample of Medicare beneficiaries. MAIN OUTCOME MEASURES: Use of 3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitors (statins), beta-blockers, and nitrates, and out-of-pocket expenditures for prescription drugs, stratified by type of health insurance: Medicare without drug coverage (Medicare only or self-purchased supplemental insurance) or with drug coverage (Medicaid, other public program, Medigap, health maintenance organization, or employer-sponsored plan). RESULTS: Statin use ranged from 4.1% in Medicare patients with no drug coverage to 27.4% in patients with employer-sponsored drug coverage (P<.001). Less variation between these 2 types occurred for beta-blockers (20.7% vs 36.1%; P =.003) and nitrates (20.4% vs 38.0%; P =.005). In multivariate analyses, statin use remained significantly lower for patients with Medicare only (odds ratio [OR], 0.16; 95% confidence interval [CI], 0.05-0.49) and beta-blocker use was lower for Medicaid patients (OR, 0.55; 95% CI, 0.34-0.88) vs those with employer-sponsored coverage. Nitrate use occurred less frequently in persons lacking drug coverage (patients with Medicare only, P =.049; patients with supplemental insurance without drug coverage, P =.03). Patients with Medicare only spent a much larger fraction of income on prescription drugs compared with those with employer-sponsored drug coverage (7.9% vs 1.7%; adjusted P<.001). CONCLUSION: Elderly Medicare beneficiaries with CHD who lack drug coverage have disproportionately large drug expenditures and lower use rates of statins, a class of relatively expensive drugs that improve survival.

Designing an intervention to improve the management of Helicobacter pylori infection.

BACKGROUND: An intervention to improve the testing and treatment of Helicobacter pylori (HP) in patients receiving chronic acid suppression (AS) therapy was developed at Harvard Pilgrim Health Care (HPHC), a mixed-model not-for-profit health maintenance organization. METHODS: Ten full-time primary care physicians (4 staff model and 6 group practice) were interviewed in 1999 about their knowledge, attitudes, and practice regarding dyspepsia, the use of chronic AS drugs, and approaches to HP infection, as well as about the feasibility and acceptability of various potential interventions that might be used in a quality improvement program. RESULTS: Self-reported practice regarding dyspepsia and HP infection were relatively uniform, and physicians were generally aware of current recommendations. Three common misperceptions acted as barriers to optimal HP management: Untreated HP was not considered an important problem; patients who used drugs for chronic AS rarely had HP infection; and chronic use of AS drugs was considered effective and without adverse consequence. All physicians wanted brief educational materials with explicit guidelines, preferably locally adapted and endorsed by local experts. All informants agreed that the main barrier to successful QI interventions was the requirement for any extra time or effort, particularly when directed at populations of patients who do not have symptomatic complaints. DISCUSSION: The interviews revealed the many barriers to improving the management of HP infection and to targeting educational messages and tailoring different methods for facilitating practice change across different managed care settings. Evidence-based components of the intervention program include physician education, a notification/reminder system, and practice-based tools to facilitate change and minimize workload.

Do national medicinal drug policies and essential drug programs improve drug use?: a review of experiences in developing countries.

Increasing concerns regarding access to and appropriateness of medicinal drug use have led many governments in developing countries to develop national policies and regulations intended to increase the affordability, supply, safety, and rational use of pharmaceuticals. However, little is known about the intended and unintended impacts of these social experiments on actual drug use. We conducted a critical review and synthesis of the international literature in an attempt to define the current state of knowledge regarding drug policy effects on drug use, and to extract from the evidence important lessons for future policy and research. Literature sources included the archives and computerized databases, articles published in medical and pharmacy journals, as well as published annotated bibliographies. The evaluated interventions included three broad categories: (1) multi-component national drug policies including essential drug programs; (2) drug supply and cost-sharing programs; and (3) regulatory measures. Most of these studies utilized weak research designs that evaluated programs solely on the basis of post-intervention measures. Only two studies measured pre-policy utilization, but did not include a control group. Thus, none of the results are conclusive, and the findings represent, at best, hypotheses for more rigorous studies of policy impacts. Some suggestive findings include an association between increases in the supply of essential drugs (combined with training) and more appropriate use of medications in primary care settings. In addition, preliminary data suggest some unintended effects of de-registration of drugs or upward reclassification of specific medicines. Similarly, loosening restrictions have sometimes been accompanied by increased dispensing of specific drugs by unqualified personnel. The available studies focused only on a few categories of national and regulatory policies. Because of poor study design, the results do not provide valid data to determine whether national drug policies improve drug use. Moreover, no studies have evaluated the effects of major and recent changes, such as increased use of product patents, national pharmaceutical insurance policies, and increased privatization of pharmaceutical products and services. Future studies need to explore the consequences of these emerging developments on drug access and use. Despite the difficulties inherent in evaluation of national policies, stronger research designs can and should be carried out. Interrupted time-series analysis and other more rigorous designs should become standard designs for policy evaluation in the same way that standard treatment guidelines are intended to guide medical practice.

Reducing antibiotic use in children: a randomized trial in 12 practices.

OBJECTIVE: To test whether an educational outreach intervention for families and physicians, based on the Centers for Disease Control and Prevention (CDC) principles of judicious antibiotic use, decreases antimicrobial drug prescribing for children younger than 6 years old. Setting. Twelve practices affiliated with 2 managed care organizations (MCOs) in eastern Massachusetts and northwest Washington State. Patients. All enrolled children younger than 6 years old. METHODS: Practices stratified by MCO and size were randomized to intervention or control groups. The intervention included 2 meetings of the practice with a physician peer leader, using CDC-endorsed summaries of judicious prescribing recommendations; feedback on previous prescribing rates were also provided. Parents were mailed a CDC brochure on antibiotic use, and supporting materials were displayed in waiting rooms. Automated enrollment, ambulatory visit, and pharmacy claims were used to determine rates of antibiotic courses dispensed (antibiotics/person-year) during baseline (1996-1997) and intervention (1997-1998) years. The primary analysis (for children 3 to <36 months and 36 to <72 months) assessed the impact of the intervention among children during the intervention year, controlling for covariates including patient age and baseline prescription rate. Confirmatory analyses at the practice level were also performed. RESULTS: The practices cared for 14 468 and 13 460 children in the 2 study years, respectively; 8815 children contributed data in both years. Sixty-two percent of antibiotic courses were dispensed for otitis media, 6.5% for pharyngitis, 6.3% for sinusitis, and 9.2% for colds and bronchitis. Antibiotic dispensing for children 3 to <36 months old decreased 0.41 antibiotics per person-year (18.6%) in intervention compared with 0.33 (11.5%) in control practices. Among children 36 to <72 months old, the rate decreased by 0.21 antibiotics per person-year (15%) in intervention and 0.17 (9.8%) in control practices. Multivariate analysis showed an adjusted intervention effect of 16% in the younger and 12% in the older age groups. The direction and approximate magnitude of effect were confirmed in practice-level analyses. CONCLUSIONS: A limited simultaneous educational outreach intervention for parents and providers reduced antibiotic use among children in primary care practices, even in the setting of substantial secular trends toward decreased prescribing. Future efforts to promote judicious prescribing should continue to build on growing public awareness of antibiotic overuse.

Utilization of essential medications by vulnerable older people after a drug benefit cap: importance of mental disorders, chronic pain, and practice setting.

OBJECTIVE: To identify specific characteristics of patients, physicians, and treatment settings associated with decreased receipt of essential medications in a chronically ill, older population following a Medicaid three-prescription monthly reimbursement limit (cap). DESIGN: Quasi-experiment with bivariate and multivariate regression. SETTING: Patients in the New Hampshire Medicaid program and their regular prescribing physicians. PARTICIPANTS: Three hundred and forty-three chronically ill Medicaid enrollees with regular use of essential medications for heart disease, asthma/chronic obstructive pulmonary disease, diabetes mellitus, seizure, or coagulation disorders who received an average of three or more prescriptions per month during the baseline year. MEASUREMENTS: Postcap patient-level change in standard monthly dose of essential medications compared with the baseline period, presence of 11 comorbidities (defined by regular use of specific indicator drugs), practice setting, and location of regular prescribing physician. RESULTS: The mean percentage change in standard doses of essential medications following the cap was -34.4%. Larger changes were significantly associated with several baseline measures: greater numbers of precap medications, greater numbers of comorbidities, longer hospitalizations, and greater use of ambulatory services. The three comorbidities associated with the largest relative reduction in essential drug use were psychoses/bipolar disorders, anxiety/sleep problems, and chronic pain. Patients of physicians in group practices, clinics, or hospitals tended to have smaller dose reductions than those whose physicians were in solo or small-group practice. CONCLUSIONS: Patients most at risk of reduced access to essential medications because of a reimbursement cap include those with multiple chronic illnesses requiring drug therapy, especially illnesses with a mental health component. Physicians in clinics or large group practices may have maintained patient medication regimens more effectively.

Influence of physician specialty on adoption and relinquishment of calcium channel blockers and other treatments for myocardial infarction.

OBJECTIVE: Recent reports have linked calcium channel blockers (CCBs) with an increased risk of acute myocardial infarction (AMI). We sought to determine to what extent physicians relinquished CCBs following these adverse reports and if there were differences in the use of CCBs and other AMI therapies across 3 levels of specialist involvement: generalist attendings, collaborative care (generalist with cardiologist consultation), and cardiologist attendings. DESIGN: We measured use of CCBs during hospitalization for AMI before (1992--1993) and after (1995--1996) the adverse CCB reports, controlling for hospital-, physician-, and patient-level variables. We also examined use of effective medications (aspirin, beta-blockers, thrombolytic therapy) and ineffective AMI treatments (lidocaine). SETTING: Thirty-seven community-based hospitals in Minnesota. PATIENTS: Population-based sample of 5,347 patients admitted with AMI. MEASUREMENTS: The primary outcome was prescription of a CCB at the time of discharge from hospital. Secondary outcomes included use of other effective and ineffective AMI therapies during hospitalization and at discharge. MAIN RESULTS: Compared with cardiologists, generalist attendings were less likely to use aspirin (37% vs 68%; adjusted odds ratio [OR], 0.58; 95% confidence interval [95% CI], 0.42 to 0.80) and thrombolytics (29% vs 64%; adjusted OR, 0.18; 95% CI, 0.13 to 0.25), but not beta-blockers (20% vs 46%; adjusted OR, 0.93; 95% CI, 0.66 to 1.31). From 1992--1993 to 1995--1996, the use of CCBs in patients with AMI decreased from 24% to 10%, the net result of physicians starting CCBs less often and discontinuing them more often. In multivariate models, the odds of CCB relinquishment after the adverse reports (adjusted OR, 0.33; 95% CI, 0.27 to 0.39) were independent of, and not modified by, the involvement of a cardiologist. CONCLUSIONS: Compared with cardiologists, generalist physicians were less likely to adopt some effective AMI therapies, particularly those associated with risk such as thrombolytic therapy. However, generalists were as likely as cardiologists to relinquish CCBs after the adverse reports. This pattern of practice may be the generalist physicians' response to an expanding, but increasingly risky and uncertain, pharmacopoeia.

The case for a medicare drug coverage benefit: a critical review of the empirical evidence.

The lack of an outpatient prescription drug benefit under Medicare has become a conspicuous omission in the face of accelerated growth in prescription drug expenditures and increased availability of highly effective medications. This article provides a critical review of the empirical evidence on the effect of drug coverage on the use of prescription drugs, health care outcomes, and health care costs among Medicare beneficiaries. The existing literature provides considerable evidence that drug coverage is associated with greater use of all drugs and clinically essential medications and that not all forms of coverage provide the same protection. Longitudinal evidence from elderly and disabled persons in Medicaid indicates that restricting coverage has serious adverse health outcomes for sick and low-income beneficiaries that actually lead to increased health care costs.

Use of antihypertensive drugs by Medicare enrollees: does type of drug coverage matter?

Research has demonstrated that Medicare beneficiaries with drug coverage consume more clinically essential drugs. However, generosity of coverage varies considerably across beneficiaries. This study examines the association between types of drug coverage and the consumption and cost per tablet of essential antihypertensive medications among beneficiaries with hypertension. The findings indicate that while both state- and employer-sponsored drug coverage are associated with greater consumption of antihypertensive drugs and lower out-of-pocket costs per tablet, private supplemental coverage is not associated with greater use and is associated with only slightly lower out-of-pocket costs than among noncovered beneficiaries.

On the evaluation of drug benefits policy changes with longitudinal claims data: the policy maker's versus the clinician's perspective.

Cost containment in pharmaceutical-benefit plans are often controversially debated for their potential of unintended consequences on health and overall expenditures. Thorough evaluations are needed but hypotheses and design considerations are complex. Our objective is to provide a structured framework for the evaluation of drug-benefit changes using longitudinal claims data. Differential cost sharing (DCS) will serve as a recent example. Benefit-plan managers are mainly interested in the overall performance of their plan. In a policy model, any observed policy-related effects may be compared with what would have happened had the intervention not been implemented by extrapolating the pre-policy trend from the same patients. These estimates will reflect the global consequences of the policy maker's decision. However, such estimates represent summary effects of benefits and harms, separately identifiable in those complying with the intended policy and those not complying. Results from a policy model apply only to a specific policy implementation and tend to underestimate effects when non-compliance is high. Clinical-decision makers and patients, by contrast, are interested in the consequences of patients' actual compliance to the policy. A clinical model assesses the effects of DCS depending on the actual treatment in contrast to the treatment intended by the policy. However, this model must sometimes make, unprovable assumptions about the appropriate control of selection factors. In conclusion, both policy and clinical models should be tested with a clear understanding of their perspectives, hypotheses, and interpretations, using quasi-experimental time-series designs to evaluate the effects of drug cost-containment policies.

Multicenter epidemiologic and health services research on therapeutics in the HMO Research Network Center for Education and Research on Therapeutics.

Research and education programs in therapeutics that combine the data, organizational capabilities, and expertise of several managed care organizations working in concert can serve an important role when a single organization is not large enough to address a question of interest, when diversity in populations or delivery systems is required, and when it is necessary to establish consistency of results in different settings. Nine members of the HMO Research Network, a consortium of health maintenance organizations (HMOs) that perform public domain research, have formed a Center for Education and Research on Therapeutics (CERT), sponsored by the Agency for Healthcare Research and Quality, to conduct multicenter research in therapeutics. The CERT uses a distributed organizational model with shared leadership, in which data reside at the originating organization until they are needed to support a specific study. Extraction of data from the host computer systems, and some manipulation of data, is typically accomplished through computer programs that are developed centrally, then modified for use at each site. For complex studies, pooled analysis files are created by a coordinating center, and then analysed by investigators throughout the HMOs. It is also possible to contact HMO members when necessary. This multicenter environment has several benefits, addressing: (1) a wide array of questions about the safety and effectiveness of therapeutics, (2) the impact of efforts to change clinicians' and patients' behavior, and (3) pharmacoeconomic and pharmacogenetic questions.

Association of physician and hospital volume with use of aspirin and reperfusion therapy in acute myocardial infarction.

BACKGROUND: The association between volume of patients treated and quality of care has important implications for patient referral policies and approaches to quality improvement. Most studies have focused on hospital volume alone and health outcomes. OBJECTIVES: The objective of this work was to examine the association of hospital and physician volume with use of aspirin and reperfusion therapy in the management of acute myocardial infarction (AMI) in eligible patients. METHODS: We reviewed charts of 2,215 patients treated at 35 Minnesota hospitals for AMI between October 1, 1992, and July 31, 1993, comparing use of aspirin and reperfusion therapy in eligible patients across different physician and hospital volume categories through multiple logistic regression. RESULTS: Aspirin use did not vary significantly with physician volume. Use of reperfusion therapy was reduced among the lowest-volume physicians only (adjusted OR, 0.38; 95% CI, 0.15-0.94). Compared with the highest volume hospitals (treating >200 patients), aspirin use among lower-volume hospitals was lower. This was statistically significant only in the hospitals treating <30 patients (adjusted OR, 0.54; 95% CI, 0.30-0.97). These same hospitals had increased odds of using thrombolytics (adjusted OR, 3.02; 95% CI, 1.40-6.53). CONCLUSIONS: Differences in use of aspirin and reperfusion therapy occur at the extremes of hospital and physician volume. These observed differences are in the anticipated direction, except for the increased use of thrombolytics at very-low-volume hospitals. This may be a "desperation reaction" with a perceived lack of other alternatives, such as cardiac catheterization labs and cardiologists.

Self-reported physician practices for children with asthma: are national guidelines followed?

OBJECTIVE: To determine self-reported adherence to national asthma guidelines for children by primary care physicians in managed care; and, to analyze sources of variation in these practices by physician specialty and managed care practice type. DESIGN: A survey of 671 primary care physicians (pediatricians and family physicians) practicing in 3 geographically diverse managed care organizations (MCO). Domains of interest included asthma diagnosis, pharmacotherapy, patient education and follow-up, and indications for specialty referral. Item formats included self-reports of usual practice and responses to case vignettes. RESULTS: A total of 429 (64%) physicians returned surveys, 22 of whom did not meet criteria for inclusion in the analysis. Most respondents had both heard of (91%) and read (72%) the National Asthma Education and Prevention Program (NAEPP) guidelines. For diagnosis, 75% reported routine use of office peak flow measurement, but only 21% used spirometry routinely. Family physicians were more likely than pediatricians to use spirometry in diagnosis (odds ratio [OR] = 5.9), and less likely to recommend daily peak flow measurement (OR =.3). The median reported frequency of providing written care plans was only 50%. Though inhaled corticosteroids were deemed very safe or safe by 93%, almost half had specific concerns regarding at least 1 side effect, most commonly growth delay. Primary care physicians' criteria for referral to an asthma specialist differed from those of the NAEPP panel in choosing to manage more severe patients without asthma specialist input. Family physicians were more likely than pediatricians to refer a child after a single hospitalization, 2 to 3 emergency department visits, after 2 exacerbations, or if the child was <3 years old and required daily medications. Responses to vignettes showed generally appropriate initial use of antiinflammatory agents, but reluctance to increase the dose in response to continued symptoms, and less frequent follow-up than recommended by the NAEPP. CONCLUSION: Most physicians for children report having read and adopted NAEPP guideline recommendations for asthma treatment, including generally appropriate use of medications. Opportunities for improvement exist in specific areas such as the use of written care plans, optimizing antiinflammatory dosing, and providing routine follow-up. Although physicians show evidence of awareness of national guidelines and knowledge consistent with much of their content, additional work is required to promote the use of self-management tools in practice.

Improving discussion of surgical treatment options for patients with breast cancer: local medical opinion leaders versus audit and performance feedback.

We studied whether a hospital intervention utilizing medical opinion leaders and performance feedback reduced the proportion of women who reported that surgeons did not discuss options prior to surgery for early stage breast cancer. Opinion leaders provided clinical education to their peers using a variety of strategies and were selected for their ability to influence their peers. Performance feedback involved distributing performance reports that contained data on the outcomes of interest as well as on other treatment patterns. Twenty-eight hospitals in Minnesota were randomized to the intervention or to a control group that received performance feedback only. The proportion of patients at intervention hospitals who said that their surgeon did not discuss options decreased significantly (p < 0.001) from 33% to 17%, but a similar decrease was observed among control hospitals. Using medical opinion leaders to intervene in hospitals appeared as effective as performance feedback.

Coverage by the news media of the benefits and risks of medications.

BACKGROUND: The news media are an important source of information about new medical treatments, but there is concern that some coverage may be inaccurate and overly enthusiastic. METHODS: We studied coverage by U.S. news media of the benefits and risks of three medications that are used to prevent major diseases. The medications were pravastatin, a cholesterol-lowering drug for the prevention of cardiovascular disease; alendronate, a bisphosphonate for the treatment and prevention of osteoporosis; and aspirin, which is used for the prevention of cardiovascular disease. We analyzed a systematic probability sample of 180 newspaper articles (60 for each drug) and 27 television reports that appeared between 1994 and 1998. RESULTS: Of the 207 stories, 83 (40 percent) did not report benefits quantitatively. Of the 124 that did, 103 (83 percent) reported relative benefits only, 3 (2 percent) absolute benefits only, and 18 (15 percent) both absolute and relative benefits. Of the 207 stories, 98 (47 percent) mentioned potential harm to patients, and only 63 (30 percent) mentioned costs. Of the 170 stories citing an expert or a scientific study, 85 (50 percent) cited at least one expert or study with a financial tie to a manufacturer of the drug that had been disclosed in the scientific literature. These ties were disclosed in only 33 (39 percent) of the 85 stories. CONCLUSIONS: News-media stories about medications may include inadequate or incomplete information about the benefits, risks, and costs of the drugs as well as the financial ties between study groups or experts and pharmaceutical manufacturers.

Timeliness and quality of care for elderly patients with acute myocardial infarction under health maintenance organization vs fee-for-service insurance.

BACKGROUND: A commonly voiced concern is that health maintenance organizations (HMOs) may withhold or delay the provision of urgent, essential care, especially for vulnerable patients like the elderly. OBJECTIVE: To compare the quality of emergency care provided in Minnesota to elderly patients with acute myocardial infarction (AMI) who are covered by HMO vs fee-for-service (FFS) insurance. METHODS: We reviewed the medical records of 2304 elderly Medicare patients who were admitted with AMI to 20 urban community hospitals in Minnesota (representing 91% of beds in areas served by HMOs) from October 1992 through July 1993 and from July 1995 through April 1996. MAIN OUTCOME MEASURES: Use of emergency transportation and treatment delay (>6 hours from symptom onset); time to electrocardiogram; use of aspirin, thrombolytics, and beta-blockers among eligible patients; and time from hospital arrival to thrombolytic administration (door-to-needle time). RESULTS: Demographic characteristics, severity of symptoms, and comorbidity characteristics were almost identical among HMO (n = 612) and FFS (n = 1692) patients. A cardiologist was involved as a consultant or the attending physician in the care of 80% of HMO patients and 82% of FFS patients (P = .12). The treatment delay, time to electrocardiogram, use of thrombolytic agents, and door-to-needle times were almost identical. However, 56% of HMO patients and 51% of FFS patients used emergency transportation (P = .02); most of this difference was observed for patients with AMIs that occurred at night (60% vs 52%; P = .02). Health maintenance organization patients were somewhat more likely than FFS patients to receive aspirin therapy (88% vs 83%; P = .03) and beta-blocker therapy (73% vs 62%; P = .04); these differences were partly explained by a significantly larger proportion of younger physicians in HMOs who were more likely to order these drug therapies. All differences were consistent across the 3 largest HMOs (1 staff-group model and 2 network model HMOs). Logistic regression analyses controlling for demographic and clinical variables produced similar results, except that the differences in the use of beta-blockers became insignificant. CONCLUSIONS: No indicators of timeliness and quality of care for elderly patients with AMIs were lower under HMO vs FFS insurance coverage in Minnesota. However, two indicators of quality care were slightly but significantly higher in the HMO setting (use of emergency transportation and aspirin therapy). Further research is needed in other states, in different populations, and for different medical conditions.