Readers' and author's responses to "are traditional peer-reviewed medical articles obsolete?".
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Internet↗
Biomedical subjects
Michael J Goodman
Publications and source records attributed to Michael J Goodman.
Influenza vaccination health impact and cost effectiveness among adults aged 50 to 64 and 65 and older.
BACKGROUND: Influenza causes approximately 36,000 deaths per year in the United States despite the presence of an effective vaccine. This assessment of the value of influenza vaccination to the U.S. population is part of an update to the 2001 ranking of clinical preventive services recommended by the U.S. Preventive Services Task Force. The forthcoming ranking will include the new recommendation of the Advisory Committee on Immunization Practices to extend influenza vaccination to adults aged 50 to 64 years. METHODS: This service is evaluated on the two most important dimensions: burden of disease prevented and cost effectiveness. Study methods, described in a companion article, are designed to ensure consistency across many services. RESULTS: Over the lifetime of a birth cohort of 4 million, it is estimated that about 275,000 quality-adjusted life years (QALYs) would be saved if influenza vaccination were offered annually to all people after age 50. Eighty percent of the QALYs saved (220,000) would be achieved by offering the vaccine only to persons aged 65 and older. In year 2000 dollars, the cost effectiveness of influenza vaccination is $980 per QALY saved in persons aged 65 and older, and $28,000 per QALY saved in persons aged 50 to 64. When the costs of patient time and travel are excluded, the cost effectiveness ratio of vaccinating 50- to 64-year-olds decreases to $7200 per QALY saved, and vaccinating those aged 65 and older saves $17 per person vaccinated. CONCLUSIONS: Influenza vaccination is a high-impact, cost-effective service for persons aged 65 and older. Vaccinations are also cost effective for persons aged 50 to 64.
Aged↗
Colorectal cancer screening: health impact and cost effectiveness.
BACKGROUND: Colorectal cancer is the second leading cause of cancer-related death in the United States, yet recommended screenings are not delivered to most people. This assessment of colorectal cancer screening's value to the U.S. population is part of the update to a 2001 ranking of recommended clinical preventive services found in the accompanying article. This article describes the burden of disease prevented and cost-effectiveness as a result of offering patients a choice of colorectal cancer screening tools. METHODS: Methods used were designed to ensure consistent estimates across many services and are described in more detail in the companion articles. In a secondary analysis, the authors also estimated the impact of increasing offers for colorectal cancer screening above current levels among the current cross-section of adults aged 50 and older. RESULTS: If a birth cohort of 4 million were offered screening at recommended intervals, 31,500 deaths would be prevented and 338,000 years of life would be gained over the lifetime of the birth cohort. In the current cross-section of people aged 50 and older, 18,800 deaths could be prevented each year by offering all people in this group screening at recommended intervals. Only 58% of these deaths are currently being prevented. In year 2000 dollars, the cost effectiveness of offering patients aged 50 and older a choice of colorectal cancer screening options is $11,900 per year of life gained. CONCLUSIONS: Colorectal cancer screening is a high-impact, cost-effective service used by less than half of persons aged 50 and older.
Colonoscopy↗
Priorities among effective clinical preventive services: methods.
Decision makers want to know which healthcare services matter the most, but there are no well-established, practical methods for providing evidence-based answers to such questions. Led by the National Commission on Prevention Priorities, the authors update the methods for determining the relative health impact and economic value of clinical preventive services. Using new studies, new preventive service recommendations, and improved methods, the authors present a new ranking of clinical preventive services in the companion article. The original ranking and methods were published in this journal in 2001. The current methods report focuses on evidence collection for a priority setting exercise, guidance for which is effectively lacking in the literature. The authors describe their own standards for searching, tracking, and abstracting literature for priority setting. The authors also summarize their methods for making valid comparisons across different services. This report should be useful to those who want to understand additional detail about how the ranking was developed or who want to adapt the methods for their own purposes.
Cost-Benefit Analysis↗
Priorities among effective clinical preventive services: results of a systematic review and analysis.
BACKGROUND: Decision makers at multiple levels need information about which clinical preventive services matter the most so that they can prioritize their actions. This study was designed to produce comparable estimates of relative health impact and cost effectiveness for services considered effective by the U.S. Preventive Services Task Force and Advisory Committee on Immunization Practices. METHODS: The National Commission on Prevention Priorities (NCPP) guided this update to a 2001 ranking of clinical preventive services. The NCPP used new preventive service recommendations up to December 2004, improved methods, and more complete and recent data and evidence. Each service received 1 to 5 points on each of two measures--clinically preventable burden and cost effectiveness--for a total score ranging from 2 to 10. Priorities for improving delivery rates were established by comparing the ranking with what is known of current delivery rates nationally. RESULTS: The three highest-ranking services each with a total score of 10 are discussing aspirin use with high-risk adults, immunizing children, and tobacco-use screening and brief intervention. High-ranking services (scores of 6 and above) with data indicating low current utilization rates (around 50% or lower) include: tobacco-use screening and brief intervention, screening adults aged 50 and older for colorectal cancer, immunizing adults aged 65 and older against pneumococcal disease, and screening young women for Chlamydia. CONCLUSION: This study identifies the most valuable clinical preventive services that can be offered in medical practice and should help decision-makers select which services to emphasize.
Adult↗
Repeated tobacco-use screening and intervention in clinical practice: health impact and cost effectiveness.
BACKGROUND: This report updates 2001 estimates of disease burden prevented and cost effectiveness of tobacco-use screening and brief intervention relative to that of other clinical preventive services. It also addresses repeated counseling because the literature has focused on single episodes of treatment, while in reality that is neither desirable nor likely. METHODS: Literature searches led to four models for calculating the clinically preventable burden of deaths and morbidity from smoking as well as the cost effectiveness of providing the service annually over time. The same methods were used in similar calculations for other preventive services to facilitate comparison. RESULTS: Using methods consistent with existing literature for this service, an estimated 190,000 undiscounted quality-adjusted life years (QALYs) are saved at a cost of $1100 per QALY saved (discounted). These estimates exclude financial savings from smoking-attributable disease prevented and use the average 12-month quit rate in clinical practice for tobacco screening and brief cessation counseling with cessation medications (5.0%) and without (2.4%). Including the savings of prevented smoking-attributable disease and using the effectiveness of repeated interventions over the lifetime of smokers (23.1%), 2.47 million QALYs are saved at a cost savings of $500 per smoker who receives the service. CONCLUSIONS: This analysis makes repeated clinical tobacco-cessation counseling one of the three most important and cost-effective preventive services that can be provided in medical practice. Greater efforts are needed to achieve more of this potential value by increasing current low levels of performance.
Clinical Trials as Topic↗
Vaccine adverse event reporting system reporting source: a possible source of bias in longitudinal studies.
OBJECTIVE: The US Vaccine Adverse Event Reporting System (VAERS) is a passive reporting system to which anyone can report an event. Publicity related to potential adverse events may change reporting patterns. The objective of this paper is to show how litigation-related reports have influenced the trends in possible adverse event reports to VAERS. METHODS: The VAERS public-use data files were downloaded in July 2004 and translated into identical SAS data sets for analysis. Cases that were related to litigation were identified using a word search algorithm. All cases for the most frequently reported symptoms in litigation (overdose, neuropathy, autism, "mental retardation," arthralgia, and "speech disorder") were reviewed. RESULTS: In recent years, most case reports to VAERS that were related to overdose, neuropathy, and thimerosal were related to litigation. Many cases that were related to autism and mental retardation were as well. CONCLUSIONS: This review shows a previously undisclosed rise in the number of reports to the VAERS related to pending litigation for vaccine injury. The implications of this for understanding longitudinal reporting patterns are discussed.
Adverse Drug Reaction Reporting Systems↗
The safety of trivalent influenza vaccine among healthy children 6 to 24 months of age.
OBJECTIVE: The objective of this study was to assess the safety of routine trivalent influenza vaccine (TIV) administration among healthy children 6 through 23 months of age, after the Advisory Committee on Immunization Practices recommendation. METHODS: The study was a retrospective case-control study of children receiving TIV in the first 2 seasons after the Advisory Committee on Immunization Practices recommendation. We assessed outcomes in the 42 days after vaccination in a population of 13,383 children. Each case subject was matched, according to age and gender, with 3 control subjects. Hazard ratios were calculated with conditional logistic regression analysis. RESULTS: We found no statistically significantly elevated hazard ratios for the first TIV dose. An elevated risk of pharyngitis was found for children receiving a second TIV dose. No elevated risk of seizure was found. CONCLUSION: These results, for a population of healthy children, showed no medically significant adverse events related to TIV among children 6 to 23 months of age.
Case-Control Studies↗
Health plan administrative databases can efficiently identify serious myopathy and rhabdomyolysis.
OBJECTIVE: We evaluated the positive predictive values (PPVs) of specific criteria based upon International Classification of Diseases, 9th revision (ICD-9-CM) codes documented in health plan administrative databases for identification of cases of serious myopathy and rhabdomyolysis. STUDY DESIGN AND SETTING: We conducted a retrospective study among patients enrolled in 11 geographically dispersed managed care organizations. Cohorts of new users of specific statins and fibrates were identified by selecting patients with an initial dispensing of the drug during the period 1 January 1998 to 30 June 2001. Potential cases of serious myopathy or rhabdomyolysis were identified using specific criteria based upon ICD-9-CM codes suggesting a muscle disorder or acute renal failure. RESULTS: A total of 194 hospitalizations meeting the criteria for chart review selection were identified among 206,732 new users of statins and 15,485 new users of fibrates. Overall, 31 cases of serious, clinically important myopathy or rhabdomyolysis (18%) were confirmed through chart review. Of these, 26 (84%) had a claim including codes for myoglobinuria (ICD-9-CM 791.3) or other disorders of muscle, ligament, and fascia (ICD-9-CM 728.89). A PPV of 74% (26 of 35 patients meeting criteria) was found for a composite definition that included (1) a primary or secondary discharge code for myoglobinuria, (2) a primary code for "other disorders of muscle," or (3) a secondary code for "other disorders of muscle" accompanied by a claim for a CK test within 7 days of hospitalization or a discharge code for acute renal failure. CONCLUSION: For rare adverse events such as serious myopathy or rhabdomyolysis, large population-based databases that include diagnosis and laboratory test claims data can facilitate epidemiologic research.
Data Interpretation, Statistical↗
Creating standard cost measures across integrated health care delivery systems.
BACKGROUND: Economic analyses are increasingly important in medical research. Accuracy often requires that they include large, diverse populations, which requires data from multiple sources. The difficulty is in making the data comparable across different settings. This article focuses on how to create comparable measures of health care resource use and cost using data from seven health plans and delivery systems participating in the Cancer Research Network's HMOs Investigating Tobacco study. METHODS: We used a data inventory to identify variation in data capture across sites and used data dictionaries to develop algorithms for assigning standardized cost to the three major components of health care use: outpatient, inpatient, and pharmacy. RESULTS: The plans included in this study varied from fully integrated, closed-panel models to plans and delivery systems that include network or independent physician association components. Information derived from the data inventory and data dictionary instruments demonstrated a substantial variation in both the content and capture of data across all sites and across all components of usage. The methods we employed for cost allocation varied by usage component and were based on our ability to leverage the data points available to best reflect actual resource use. CONCLUSIONS: The importance of this article is the method of ascertaining, cataloging, and addressing the within- and between-plan differences in health care resource use. Second, the decisions we made to address the differences between health plans provide other researchers a starting point when creating a cost algorithm for multisite retrospective research.
Adult↗
Effect of increased cost-sharing on oral hypoglycemic use in five managed care organizations: how much is too much?
BACKGROUND: For patients with a chronic disease, increased cost-sharing for medications may lead to unintended consequences, including reduced use of medications essential for control of their disease. OBJECTIVE: The objective of this study was to estimate the effects of small ($1-6 per 30-day supply), moderate ($7-10), and large (>$10) increases in medication cost-sharing on 12-month trends in oral hypoglycemic (OH) use among adults with type 2 diabetes. METHODS: We conducted a quasiexperimental study using a time series with comparison group design. Data were obtained from computerized membership, benefit, and pharmacy dispensing data of 5 managed care organizations (MCOs). A total of 13,110 12-month episodes of OH use and a medication cost-sharing increase ("intervention") were matched with 13,110 that had no increase. The dependent variable was OH average daily dose (ADD) standardized to each episode's mean OH ADD in the 6-month preintervention period. The principal independent variable was change in cost per 30-day OH supply between the 6-month pre- and postintervention periods. Effects of changes in cost-sharing on OH ADD were estimated using segmented time series regression. RESULTS: Episodes with >$10 increase in cost-sharing had significantly (alpha=0.05) decreased OH ADD in the postintervention period. At 6 months after this increase, OH ADD had decreased by 18.5% from that predicted from the preintervention trend. Episodes with a $1 to $10 increase in cost-sharing and those with no increase in cost-sharing had significant linear increases in OH use over the 12-month period. CONCLUSIONS: Large increases in medication cost-sharing were associated with immediate and persistent reductions in OH use. Small and moderate increases had little effect on OH use in the 6-month period after the increase.
Adolescent↗
Simulated anthrax attacks and syndromic surveillance.
We measured sensitivity and timeliness of a syndromic surveillance system to detect bioterrorism events. A hypothetical anthrax release was modeled by using zip code population data, mall customer surveys, and membership information from HealthPartners Medical Group, which covers 9% of a metropolitan area population in Minnesota. For each infection level, 1,000 releases were simulated. Timing of increases in use of medical care was based on data from the Sverdlovsk, Russia, anthrax release. Cases from the simulated outbreak were added to actual respiratory visits recorded for those dates in HealthPartners Medical Group data. Analysis was done by using the space-time scan statistic. We evaluated the proportion of attacks detected at different attack rates and timeliness to detection. Timeliness and completeness of detection of events varied by rate of infection. First detection of events ranged from days 3 to 6. Similar modeling may be possible with other surveillance systems and should be a part of their evaluation.
Anthrax↗
Incidence of hospitalized rhabdomyolysis in patients treated with lipid-lowering drugs.
CONTEXT: Lipid-lowering agents are widely prescribed in the United States. Reliable estimates of rhabdomyolysis risk with various lipid-lowering agents are not available. OBJECTIVE: To estimate the incidence of rhabdomyolysis in patients treated with different statins and fibrates, alone and in combination, in the ambulatory setting. DESIGN, SETTING, AND PATIENTS: Drug-specific inception cohorts of statin and fibrate users were established using claims data from 11 managed care health plans across the United States. Patients with at least 180 days of prior health plan enrollment were entered into the cohorts between January 1, 1998, and June 30, 2001. Person-time was classified as monotherapy or combined statin-fibrate therapy. MAIN OUTCOME MEASURE: Incidence rates of rhabdomyolysis per 10,000 person-years of treatment, number needed to treat, and relative risk of rhabdomyolysis. RESULTS: In 252,460 patients treated with lipid-lowering agents, 24 cases of hospitalized rhabdomyolysis occurred during treatment. Average incidence per 10,000 person-years for monotherapy with atorvastatin, pravastatin, or simvastatin was 0.44 (95% confidence interval [CI], 0.20-0.84); for cerivastatin, 5.34 (95% CI, 1.46-13.68); and for fibrate, 2.82 (95% CI, 0.58-8.24). By comparison, the incidence during unexposed person-time was 0 (95% CI, 0-0.48; P = .056). The incidence increased to 5.98 (95% CI, 0.72-216.0) for combined therapy of atorvastatin, pravastatin, or simvastatin with a fibrate, and to 1035 (95% CI, 389-2117) for combined cerivastatin-fibrate use. Per year of therapy, the number needed to treat to observe 1 case of rhabdomyolysis was 22,727 for statin monotherapy, 484 for older patients with diabetes mellitus who were treated with both a statin and fibrate, and ranged from 9.7 to 12.7 for patients who were treated with cerivastatin plus fibrate. CONCLUSIONS: Rhabdomyolysis risk was similar and low for monotherapy with atorvastatin, pravastatin, and simvastatin; combined statin-fibrate use increased risk, especially in older patients with diabetes mellitus. Cerivastatin combined with fibrate conferred a risk of approximately 1 in 10 treated patients per year.
Clofibric Acid↗
Secondary gait compensations in individuals without neuromuscular involvement following a unilateral imposed equinus constraint.
Ankle equinus is the most commonly identified impairment of individuals with spastic hemiplegia (SH). However, it is not clear how equinus at the ankle may contribute to gait deviations at other joints. The purpose of this study was to determine what compensatory gait deviations may occur as a result of an imposed, unilateral equinus constraint. Gait data were collected on 12 adult subjects with and without one ankle constrained in equinus using a unique taping method. Knee extension at initial contact, knee extension in mid stance, and hip extension at terminal stance were all found to be significantly reduced on the ipsilateral side as a result of the ankle constraint. On the unconstrained or contralateral side, subjects tended to adopt a foot-flat or toe-first initial contact pattern. This study suggests that stance phase limitations in both hip and knee extension in the gait of persons with hemiplegia are not necessarily caused by limited length of the involved side hamstrings and/or hip flexors, but rather that they can occur as the result of an ankle plantarflexor contracture alone. Deviations in the contralateral foot contact pattern can also occur secondary to unilateral equinus and should not be assumed to represent bilateral involvement.
Adult↗
Opportunities and challenges for measuring cost, quality, and clinical effectiveness in health care.
Empirical studies of health care cost, productivity, and output have focused primarily on intermediate goods and services. Consumers are ultimately interested in final goods such as improved health or health-related quality of life, but health services research continues to address whether health services financing and delivery are structured in ways to maximize production of intermediate goods, regardless of the link between these services and final outcomes. Increasing rates of growth of health care cost and dissatisfaction with the quality of U.S. health care force us to reexamine how productivity and cost are analyzed so that research properly informs policy and practice. The authors examine recent changes in the U.S. health care sector that suggest the need to revise how health services research approaches analyses of cost, production, and output; consider alternative notions of final goods; and review the availability and quality of data necessary to conduct this research.
Cost-Benefit Analysis↗
Does payment drive procedures? Payment for specialty services and procedure rate variations in 3 HMOs.
OBJECTIVE: To study how payment for specialty services affects the rates of performance of invasive procedures by physicians in a number of specialties. STUDY DESIGN: Observational study. PATIENTS AND METHODS: Administrative data from 1996-1997 and 1997-1998 from 3 large health maintenance organizations (HMOs) in the Midwestern and western United States were used to study variations in procedure rates associated with different methods of paying for cardiology, gastroenterology, ophthalmology, orthopedic, and ear, nose and throat services within each HMO. The age-, sex-, and comorbidity adjusted probabilities of undergoing selected, potentially discretionary procedures, were compared within each plan by payment method. RESULTS: After adjustment, rates under fee-for-service payment tended to be higher than those under capitation or salary payment, whereas there was no clear pattern for salary versus capitation payment. Even within a single specialty in a single plan, however, rates did not always follow the same pattern for different procedures. CONCLUSIONS: The payment method for specialty services used by these 3 health plans was variably associated with how likely patients were to undergo a variety of invasive procedures. The effects of contract payment methods for specialty services on health care costs, quality, and outcomes should be further studied, but such studies will challenge the capabilities of health plan data systems.
Adult↗
Risk adjustment using automated ambulatory pharmacy data: the RxRisk model.
OBJECTIVES: Develop and estimate the RxRisk model, a risk assessment instrument that uses automated ambulatory pharmacy data to identify chronic conditions and predict future health care cost. The RxRisk model's performance in predicting cost is compared with a demographic-only model, the Ambulatory Clinical Groups (ACG), and Hierarchical Coexisting Conditions (HCC) ICD-9-CM diagnosis-based risk assessment instruments. Each model's power to forecast health care resource use is assessed. DATA SOURCES: Health services utilization and cost data for approximately 1.5 million individuals enrolled in five mixed-model Health Maintenance Organizations (HMOs) from different regions in the United States. STUDY DESIGN: Retrospective cohort study using automated managed care data. SUBJECTS All persons enrolled during 1995 and 1996 in Group Health Cooperative of Puget Sound, HealthPartners of Minnesota and the Colorado, Ohio and Northeast Regions of Kaiser-Permanente. MEASURES RxRisk, an algorithm that classifies prescription drug fills into chronic disease classes for adults and children. RESULTS: HCCs produce the most accurate forecasts of total costs than either RxRisk or ACGs but RxRisk performs similarly to ACGs. Using the R(2) criteria HCCs explain 15.4% of the prospective variance in cost, whereas RxRisk explains 8.7% and ACGs explain 10.2%. However, for key segments of the cost distribution the differences in forecasting power among HCCs, RxRisk, and ACGs are less obvious, with all three models generating similar predictions for the middle 60% of the cost distribution. CONCLUSIONS: HCCs produce more accurate forecasts of total cost, but the pharmacy-based RxRisk is an alternative risk assessment instrument to several diagnostic based models and depending on the nature of the application may be a more appropriate option for medical risk analysis.
Adolescent↗
Using risk-adjustment models to identify high-cost risks.
BACKGROUND: We examine the ability of various publicly available risk models to identify high-cost individuals and enrollee groups using multi-HMO administrative data. METHODS: Five risk-adjustment models (the Global Risk-Adjustment Model [GRAM], Diagnostic Cost Groups [DCGs], Adjusted Clinical Groups [ACGs], RxRisk, and Prior-expense) were estimated on a multi-HMO administrative data set of 1.5 million individual-level observations for 1995-1996. Models produced distributions of individual-level annual expense forecasts for comparison to actual values. Prespecified "high-cost" thresholds were set within each distribution. The area under the receiver operating characteristic curve (AUC) for "high-cost" prevalences of 1% and 0.5% was calculated, as was the proportion of "high-cost" dollars correctly identified. Results are based on a separate 106,000-observation validation dataset. MAIN RESULTS: For "high-cost" prevalence targets of 1% and 0.5%, ACGs, DCGs, GRAM, and Prior-expense are very comparable in overall discrimination (AUCs, 0.83-0.86). Given a 0.5% prevalence target and a 0.5% prediction threshold, DCGs, GRAM, and Prior-expense captured $963,000 (approximately 3%) more "high-cost" sample dollars than other models. DCGs captured the most "high-cost" dollars among enrollees with asthma, diabetes, and depression; predictive performance among demographic groups (Medicaid members, members over 64, and children under 13) varied across models. CONCLUSIONS: Risk models can efficiently identify enrollees who are likely to generate future high costs and who could benefit from case management. The dollar value of improved prediction performance of the most accurate risk models should be meaningful to decision-makers and encourage their broader use for identifying high costs.
Adolescent↗