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1.
JAMA ; 330(15): 1437-1447, 2023 10 17.
Artigo em Inglês | MEDLINE | ID: mdl-37847273

RESUMO

Importance: The Million Hearts Model paid health care organizations to assess and reduce cardiovascular disease (CVD) risk. Model effects on long-term outcomes are unknown. Objective: To estimate model effects on first-time myocardial infarctions (MIs) and strokes and Medicare spending over a period up to 5 years. Design, Setting, and Participants: This pragmatic cluster-randomized trial ran from 2017 to 2021, with organizations assigned to a model intervention group or standard care control group. Randomized organizations included 516 US-based primary care and specialty practices, health centers, and hospital-based outpatient clinics participating voluntarily. Of these organizations, 342 entered patients into the study population, which included Medicare fee-for-service beneficiaries aged 40 to 79 years with no previous MI or stroke and with high or medium CVD risk (a 10-year predicted probability of MI or stroke [ie, CVD risk score] ≥15%) in 2017-2018. Intervention: Organizations agreed to perform guideline-concordant care, including routine CVD risk assessment and cardiovascular care management for high-risk patients. The Centers for Medicare & Medicaid Services paid organizations to calculate CVD risk scores for Medicare fee-for-service beneficiaries. CMS further rewarded organizations for reducing risk among high-risk beneficiaries (CVD risk score ≥30%). Main Outcomes and Measures: Outcomes included first-time CVD events (MIs, strokes, and transient ischemic attacks) identified in Medicare claims, combined first-time CVD events from claims and CVD deaths (coronary heart disease or cerebrovascular disease deaths) identified using the National Death Index, and Medicare Parts A and B spending for CVD events and overall. Outcomes were measured through 2021. Results: High- and medium-risk model intervention beneficiaries (n = 130 578) and standard care control beneficiaries (n = 88 286) were similar in age (median age, 72-73 y), sex (58%-59% men), race (7%-8% Black), and baseline CVD risk score (median, 24%). The probability of a first-time CVD event within 5 years was 0.3 percentage points lower for intervention beneficiaries than control beneficiaries (3.3% relative effect; adjusted hazard ratio [HR], 0.97 [90% CI, 0.93-1.00]; P = .09). The 5-year probability of combined first-time CVD events and CVD deaths was 0.4 percentage points lower in the intervention group (4.2% relative effect; HR, 0.96 [90% CI, 0.93-0.99]; P = .02). Medicare spending for CVD events was similar between the groups (effect estimate, -$1.83 per beneficiary per month [90% CI, -$3.97 to -$0.30]; P = .16), as was overall Medicare spending including model payments (effect estimate, $2.11 per beneficiary per month [90% CI, -$16.66 to $20.89]; P = .85). Conclusions and Relevance: The Million Hearts Model, which encouraged and paid for CVD risk assessment and reduction, reduced first-time MIs and strokes. Results support guidelines to use risk scores for CVD primary prevention. Trial Registration: ClinicalTrials.gov Identifier: NCT04047147.


Assuntos
Medicare , Modelos Cardiovasculares , Infarto do Miocárdio , Acidente Vascular Cerebral , Idoso , Feminino , Humanos , Masculino , Planos de Pagamento por Serviço Prestado/economia , Planos de Pagamento por Serviço Prestado/estatística & dados numéricos , Gastos em Saúde/estatística & dados numéricos , Medicare/economia , Medicare/estatística & dados numéricos , Infarto do Miocárdio/economia , Infarto do Miocárdio/epidemiologia , Infarto do Miocárdio/prevenção & controle , Assistência ao Paciente/estatística & dados numéricos , Acidente Vascular Cerebral/economia , Acidente Vascular Cerebral/epidemiologia , Acidente Vascular Cerebral/prevenção & controle , Estados Unidos/epidemiologia , Adulto , Pessoa de Meia-Idade , Medição de Risco/economia , Medição de Risco/estatística & dados numéricos
2.
Med Care ; 56(4): 299-307, 2018 04.
Artigo em Inglês | MEDLINE | ID: mdl-29462078

RESUMO

BACKGROUND: The Center for Medicare & Medicaid Innovation (CMMI) tests new models of paying for or delivering health care services and expands models that improve health outcomes while lowering medical spending. CMMI gave TransforMED, a national learning and dissemination contractor, a 3-year Health Care Innovation Award (HCIA) to integrate health information technology systems into physician practices. This paper estimates impacts of TransforMED's HCIA-funded program on patient outcomes and Medicare parts A and B spending. RESEARCH DESIGN: We compared outcomes for Medicare fee-for-service (FFS) beneficiaries served by 87 treatment practices to outcomes for Medicare FFS beneficiaries served by 286 matched comparison practices, adjusting for differences in outcomes between the 2 groups during a 1-year baseline period. We estimated impacts in 3 evaluation outcome domains: quality-of-care processes, service use, and spending. RESULTS: We estimated the program led to a 7.1% reduction in inpatient admissions and a 5.7% decrease in the outpatient emergency department visits. However, there was no evidence of statistically significant effects in outcomes in either the quality-of-care processes or spending domains. CONCLUSIONS: These results indicate that TransforMED's program reduced service use for Medicare FFS beneficiaries, but also show that the program did not have statistically significant favorable impacts in the quality-of-care processes or spending domains. These results suggest that providing practices with population health management and cost-reporting software-along with technical assistance for how to use them-can complement practices' own patient-centered medical home transformation efforts and add meaningfully to their impacts on service use.


Assuntos
Informática Médica/estatística & dados numéricos , Medicare/economia , Medicare/estatística & dados numéricos , Assistência Centrada no Paciente/estatística & dados numéricos , Atenção Primária à Saúde/estatística & dados numéricos , Continuidade da Assistência ao Paciente , Serviço Hospitalar de Emergência/estatística & dados numéricos , Planos de Pagamento por Serviço Prestado , Feminino , Gastos em Saúde/estatística & dados numéricos , Humanos , Revisão da Utilização de Seguros , Masculino , Informática Médica/organização & administração , Admissão do Paciente/estatística & dados numéricos , Assistência Centrada no Paciente/organização & administração , Atenção Primária à Saúde/organização & administração , Indicadores de Qualidade em Assistência à Saúde , Qualidade da Assistência à Saúde/estatística & dados numéricos , Estados Unidos
3.
Psychiatr Serv ; 74(9): 911-920, 2023 09 01.
Artigo em Inglês | MEDLINE | ID: mdl-36916061

RESUMO

OBJECTIVE: The Certified Community Behavioral Health Clinic (CCBHC) demonstration is designed to increase access to comprehensive ambulatory care and crisis services, which may reduce emergency department (ED) visits and hospitalizations. This study examined whether the demonstration had an impact on ED visits and hospitalizations in Missouri, Oklahoma, and Pennsylvania. METHODS: This difference-in-differences analysis used Medicaid claims data from 2015 to 2019 to examine service use during a 12-month baseline period and the first 24 months of the demonstration for beneficiaries who received care from CCBHCs and beneficiaries who received care from other behavioral health clinics in the same state, representing care as usual. Propensity score methods were used to develop treatment and comparison groups with similar characteristics. RESULTS: In Pennsylvania and Oklahoma, beneficiaries who received care from CCBHCs had a statistically significant reduction in the average number of behavioral health ED visits, relative to the comparison group (13% and 11% reductions, respectively); no impact on ED visits in Missouri was observed. The demonstration was associated with a statistically significant reduction in all-cause hospitalizations in Oklahoma, when the analysis used a 2-year rather than a 1-year baseline period, and also in Pennsylvania, when hospitalizations were truncated at the 98th percentile to exclude beneficiaries with outlier hospitalization rates. CONCLUSIONS: The CCBHC demonstration reduced behavioral health ED visits in two states, and the study also revealed some evidence of reductions in hospitalizations.


Assuntos
Hospitalização , Medicare , Estados Unidos , Humanos , Medicaid , Instituições de Assistência Ambulatorial , Serviço Hospitalar de Emergência
4.
Med Care ; 47(3): 295-301, 2009 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-19194339

RESUMO

BACKGROUND: Long-term nursing home care is primarily funded by out-of-pocket payments and public Medicaid programs. Few studies have explored price growth in nursing home care, particularly trends in the real cost of a year spent in a nursing home. OBJECTIVES: To evaluate changes in private and public prices for annual nursing home care from 1977 to 2004, and to compare nursing home price growth to overall price growth and growth in the price of medical care. RESEARCH DESIGN: We estimated annual private prices for nursing home care between 1977 and 2004 using data from the National Nursing Home Survey. We compared private nursing home price growth to public prices obtained from surveys of state Medicaid offices, and evaluated the Bureau of Labor Statistics Consumer Price Indexes to compare prices for nursing homes, medical care, and general goods and services over time. RESULTS: Annual private pay nursing homes prices grew by 7.5% annually from $8645 in 1977 to $60,249 in 2004. Medicaid prices grew by 6.7% annually from $9491 in 1979 to $48,056 in 2004. Annual price growth for private pay nursing home care outpaced medical care and other goods and services (7.5% vs. 6.6% and 4.4%, respectively) between 1977 and 2004. CONCLUSIONS: The recent rapid growth in nursing home prices is likely to persist, because of an aging population and greater disability among the near-elderly. The result will place increasing financial pressure on Medicaid programs. Better data on nursing prices are critical for policy-makers and researchers.


Assuntos
Gastos em Saúde/tendências , Medicaid/tendências , Casas de Saúde/economia , Casas de Saúde/estatística & dados numéricos , Atividades Cotidianas/classificação , Idoso , Ocupação de Leitos , Pessoas com Deficiência/estatística & dados numéricos , Honorários e Preços/tendências , Custos de Cuidados de Saúde/tendências , Pesquisas sobre Atenção à Saúde , Gastos em Saúde/estatística & dados numéricos , Tamanho das Instituições de Saúde , Humanos , Inflação , Expectativa de Vida/tendências , Medicaid/estatística & dados numéricos , Casas de Saúde/classificação , Recursos Humanos de Enfermagem/provisão & distribuição , Propriedade , Dinâmica Populacional , Qualidade da Assistência à Saúde/economia , Qualidade da Assistência à Saúde/tendências , Estados Unidos
5.
Pharmacoepidemiol Drug Saf ; 18(11): 1048-52, 2009 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-19655338

RESUMO

PURPOSE: To describe utilization patterns for anti-diabetes medications among a cohort of diabetes patients in the Military Health System (MHS) before and after warnings about rosiglitazone issued in May 2007. METHODS: We used segmented regression analysis to compare changes in the level and trend of rosiglitazone utilization and use of other anti-diabetes therapies in the period prior to the drug warnings (between April 2006 and May 2007) and the period after the warnings were issued (between October 2007 and May 2008). RESULTS: The level and trend of rosiglitazone use changed after the highly publicized warnings. The number of prescriptions filled fell by almost 7000 after the warning (p < 0.001). The number of prescriptions filled for pioglitazone, sulfonylureas, and other diabetes drugs increased significantly after the warnings (p < 0.05 in all models). Overall, the level and trend of filled prescriptions per month for all anti-diabetic drugs did not significantly change after the warnings. CONCLUSIONS: Utilization patterns changed in response to warnings about rosiglitazone. While overall utilization of anti-diabetic drugs did not change, further study is needed to determine the associated health outcomes.


Assuntos
Revisão de Uso de Medicamentos/tendências , Hipoglicemiantes/administração & dosagem , Hipoglicemiantes/efeitos adversos , Militares , Tiazolidinedionas/administração & dosagem , Tiazolidinedionas/efeitos adversos , Prescrições de Medicamentos/estatística & dados numéricos , Humanos , Revisão da Utilização de Seguros , Seguro de Serviços Farmacêuticos/estatística & dados numéricos , Militares/estatística & dados numéricos , Rosiglitazona , Estados Unidos , United States Food and Drug Administration
6.
Acad Pediatr ; 19(8): 908-916, 2019.
Artigo em Inglês | MEDLINE | ID: mdl-31176786

RESUMO

OBJECTIVE: Nearly 10% of all hospitalized children have a primary behavioral health diagnosis, but the effectiveness of treatment can be limited by caregivers' challenges navigating the behavioral health system. In this study, we assessed a novel peer-support intervention ("parent partners") designed for the caregivers of children admitted to an inpatient psychiatric unit. METHODS: We used a mixed-methods approach including 1) document review and interviews to assess implementation and 2) a difference-in-differences analysis using claims for Medicaid-enrolled children admitted to the intervention inpatient psychiatric unit and matched comparison children admitted to other inpatient psychiatric units to assess the impacts on health care use after discharge. RESULTS: Ninety-six percent of caregivers who were offered the intervention engaged with a parent partner. The primary challenges to implementation were accommodating the needs of parent partners to address behavioral health crises among their own children and initial limited engagement from behavioral health clinicians. The intervention leaders reported success in addressing these through adjustments to staffing policies, training parent partners in engagement with clinicians, and incorporating parent partners into team rounds. We did not find a statistically significant difference in follow-up outpatient behavioral health visits (adjusted treatment to comparison difference +3% [90% CI = -2%, +9%]), readmissions (+5% [-33%, +43%]), or behavioral health ED visits (-15% [-44%, +14%]). CONCLUSIONS: This novel intervention was implemented successfully, and although our study did not find statistically significant impacts on health care use after discharge, the findings for ED visits are suggestive of benefits. Parent peer support in inpatient settings warrants additional investigation.


Assuntos
Hospitalização , Transtornos Mentais , Entrevista Motivacional , Pais , Grupo Associado , Apoio Social , Adolescente , Assistência Ambulatorial/estatística & dados numéricos , Transtorno Bipolar , Criança , Aconselhamento , Transtorno Depressivo , Serviço Hospitalar de Emergência/estatística & dados numéricos , Empatia , Empoderamento , Feminino , Hospitais Pediátricos , Hospitais Psiquiátricos , Humanos , Ciência da Implementação , Masculino , Medicaid , Serviços de Saúde Mental/estatística & dados numéricos , Readmissão do Paciente/estatística & dados numéricos , Estados Unidos
7.
J Health Care Poor Underserved ; 30(2): 702-720, 2019.
Artigo em Inglês | MEDLINE | ID: mdl-31130546

RESUMO

From 2012 to 2015, Sanford Health, a large health care system, integrated behavioral health services and chronic condition care management in some of its primary care practices in the Dakotas and rural Minnesota. Using difference-in-differences analyses for fee-for-service Medicare beneficiaries attributed to 22 participating practices and 91 matched comparison practices, we found that the program increased the receipt of four recommended diabetes care processes by 8.6% (p=.048) and, by slowing the increase in emergency department (ED) visits, reduced them by 4.9% (p=.07) relative to the comparison group. However, the findings are mixed: the program did not affect hospital admissions, readmissions, or Medicare spending. In addition, the program increased admissions for ambulatory care-sensitive conditions by 13.6% (p=.07) relative to the comparison group. Sanford's program provides a concrete example of how to incorporate behavioral health services in primary care in underserved areas with some positive results on quality-of-care processes and ED utilization.


Assuntos
Doença Crônica/terapia , Transtornos Mentais/terapia , Atenção Primária à Saúde/estatística & dados numéricos , Idoso , Idoso de 80 Anos ou mais , Doença Crônica/epidemiologia , Prestação Integrada de Cuidados de Saúde/métodos , Prestação Integrada de Cuidados de Saúde/organização & administração , Prestação Integrada de Cuidados de Saúde/estatística & dados numéricos , Diabetes Mellitus/terapia , Serviço Hospitalar de Emergência/estatística & dados numéricos , Feminino , Hospitalização/estatística & dados numéricos , Humanos , Masculino , Medicare/estatística & dados numéricos , Transtornos Mentais/epidemiologia , Pessoa de Meia-Idade , Minnesota , North Dakota , População Rural , South Dakota , Resultado do Tratamento , Estados Unidos
8.
Med Care Res Rev ; 65(1): 3-39, 2008 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-18184869

RESUMO

Hospitalization of nursing home residents is costly and potentially exposes residents to iatrogenic disease and psychological harm. This article critically reviews the association between the decision to hospitalize and factors related to the residents' welfare and preferences, the providers' attitudes, and the financial implications of hospitalization. Regarding the resident's welfare, factors associated with hospitalization included sociodemographics, health characteristics, nurse staffing, the presence of ancillary services, and the use of hospices. Patient preferences (e.g., advance directives) and provider attitudes (e.g., overburdening of staff) were also associated with increased hospitalization. Finally, financial variables related to hospitalization included nursing home ownership status and state Medicaid policies, such as nursing home payment rates and bed-hold requirements. Most studies relied on potentially confounded research designs, which leave open the issue of selection bias. Nevertheless, the existing literature asserts that nursing home hospitalizations are frequent, often preventable, and related to facility practices and state Medicaid policies.


Assuntos
Hospitalização , Casas de Saúde/estatística & dados numéricos , Previsões , Humanos , Medicaid , Medicare , Estados Unidos
9.
Am J Manag Care ; 24(4): 197-202, 2018 04.
Artigo em Inglês | MEDLINE | ID: mdl-29668210

RESUMO

OBJECTIVES: To provide actionable recommendations for improving care coordination programs for children with special healthcare needs (CSHCN) in Medicaid managed care. STUDY DESIGN: Literature review and interviews with stakeholders and policy experts to adapt lessons learned from Medicare care coordination programs for CSHCN in Medicaid managed care. METHODS: We reviewed syntheses of research on Medicare care coordination programs to identify lessons learned from successful programs. We adapted findings from Medicare to CSHCN in Medicaid based on an environmental scan and discussions with experts. The scan focused on Medicaid financing and eligibility for care coordination and how these intersect with Medicaid managed care. The expert discussions included pediatricians, Medicaid policy experts, Medicaid medical directors, and a former managed care executive, all experienced in care coordination for CSHCN. RESULTS: We found 6 elements that are consistently associated with improved outcomes from Medicare care coordination programs and relevant to CSHCN in Medicaid: 1) identifying and targeting high-risk patients, 2) clearly articulating what outcomes programs are likely to improve, 3) encouraging active engagement between care coordinators and primary care providers, 4) requiring some in-person contact between care coordinators and patients, 5) facilitating information sharing among providers, and 6) supplementing care coordinators' expertise with that of other clinical experts. CONCLUSIONS: States and Medicaid managed care organizations have many options for designing effective care coordination programs for CSHCN. Their choices should account for the diversity of conditions among CSHCN, families' capacity to coordinate care, and social determinants of health.


Assuntos
Serviços de Saúde da Criança/organização & administração , Continuidade da Assistência ao Paciente/organização & administração , Crianças com Deficiência , Medicaid/organização & administração , Medicare/organização & administração , Criança , Pré-Escolar , Feminino , Humanos , Lactente , Masculino , Planejamento de Assistência ao Paciente , Estados Unidos
10.
Health Serv Res ; 42(4): 1464-82, 2007 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-17610433

RESUMO

OBJECTIVE: To investigate whether decreased anxiety associated with immediate reading of screening mammograms resulted in lower downstream utilization and costs among women with false-positive mammograms. DATA SOURCES/STUDY SETTING: We identified 1,140 women, > or =age 40, with false-positive mammograms and 12-month follow-up after participating in a trial of immediate versus batch mammographic reading between February 1999 and January 2001 in a multispecialty group managed care practice in Massachusetts. STUDY DESIGN: We determined downstream utilization and costs for study participants by immediate and batch reading status. DATA COLLECTION/EXTRACTION METHODS: Demographic, comorbidity, and medical care utilization data were obtained from survey data and computerized medical record databases. Costs included direct medical costs, patient time, travel and copayments, and additional professional time costs associated with immediate reading. PRINCIPAL FINDINGS: Immediate reading cost an additional $4.40 per screening mammogram. Women with immediate readings had more follow-up mammograms (781 versus 750, p=.018) and fewer diagnostic ultrasounds (176 versus 219, p=.016) than women with batch readings. Costs to the health plan for breast care were approximately 10 percent higher for immediate readings in multivariable analyses (p=.046), but no significant difference was seen in total societal costs (p=.072). CONCLUSIONS: Immediate mammogram reading was associated with increased costs to the health plan and changes in follow-up radiology procedures. These costs must be examined alongside beneficial effects of immediate reading.


Assuntos
Serviços de Saúde/economia , Serviços de Saúde/estatística & dados numéricos , Mamografia/economia , Mamografia/métodos , Adulto , Idoso , Ansiedade/etiologia , Custos e Análise de Custo , Demografia , Reações Falso-Positivas , Feminino , Humanos , Mamografia/psicologia , Programas de Rastreamento , Massachusetts , Pessoa de Meia-Idade , Modelos Econométricos , Fatores de Tempo
12.
Health Aff (Millwood) ; 31(5): 956-64, 2012 May.
Artigo em Inglês | MEDLINE | ID: mdl-22566434

RESUMO

Most analyses of geographic variation in Medicare spending have focused on total spending. However, focusing on the volume and intensity of specific categories of services delivered to patients could help identify ways to lower costs without having a negative impact on care. We investigated how utilization in thirteen medical service categories in Medicare Parts A and B (for hospital and physician insurance, respectively) varied across sixty communities nationwide. We found considerable geographic variation in the use of some service categories, although not all. We also found that local communities used very different combinations of types of services to produce medical care, that some service categories were substituted for others, and that the mix of service categories differed even among sites with high or low total medical utilization levels. Home health and durable medical equipment were major drivers of total geographic service use variation because of their variation across sites. They may therefore be appropriate targets for policy interventions directed at increasing efficiency.


Assuntos
Equipamentos Médicos Duráveis , Serviços de Assistência Domiciliar , Medicare/estatística & dados numéricos , Equipamentos Médicos Duráveis/economia , Serviços de Assistência Domiciliar/economia , Humanos , Revisão da Utilização de Seguros , Medicare/economia , Estados Unidos
13.
Arch Pediatr Adolesc Med ; 164(8): 720-6, 2010 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-20530290

RESUMO

OBJECTIVE: To assess racial and ethnic differences in asthma prevalence, treatment patterns, and outcomes among a diverse population of children with equal access to health care. DESIGN: Retrospective cohort analysis. SETTING: The Military Health System. PARTICIPANTS: A total of 822 900 children aged 2 through 17 years continuously enrolled throughout 2007 in TRICARE Prime, a health maintenance organization-type benefit provided by the Department of Defense. MAIN OUTCOME MEASURES: Prevalence of diagnosed asthma, potentially avoidable asthma hospitalizations, asthma-related emergency department visits, visits to asthma specialists, and use of asthma medications among children aged 2 to 4, 5 to 10, and 11 to 17 years. RESULTS: Black and Hispanic children in all age groups were significantly more likely to have an asthma diagnosis than white children (ranging from odds ratio [OR]=1.16; 95% confidence interval [CI], 1.09-1.24; to OR=2.00; 95% CI, 1.93-2.07). Black children in all age groups and Hispanic children aged 5 to 10 years were significantly more likely to have any potentially avoidable asthma hospitalizations and asthma-related emergency department visits (ranging from OR=1.24; 95% CI, 1.11-1.37; to OR=1.99; 95% CI, 1.37-2.88) and were significantly less likely to visit a specialist (ranging from OR=0.71; 95% CI, 0.61-0.82; to OR=0.88; 95% CI, 0.79-0.98) compared with white children. Black children in all age categories were significantly more likely to have filled any prescriptions for inhaled corticosteroids compared with white children (ranging from OR=1.11; 95% CI, 1.02-1.21; to OR=1.11; 95% CI, 1.04-1.19). CONCLUSIONS: Despite universal health insurance coverage, we found evidence of racial and ethnic differences in asthma prevalence, treatment, and outcomes.


Assuntos
Asma/epidemiologia , Asma/terapia , Negro ou Afro-Americano , Acessibilidade aos Serviços de Saúde/estatística & dados numéricos , Disparidades nos Níveis de Saúde , Disparidades em Assistência à Saúde/estatística & dados numéricos , Hispânico ou Latino , População Branca , Adolescente , Criança , Pré-Escolar , Estudos de Coortes , Feminino , Humanos , Masculino , Militares , Prevalência , Estudos Retrospectivos , Resultado do Tratamento , Estados Unidos
16.
Value Health ; 5(5): 390-7, 2002.
Artigo em Inglês | MEDLINE | ID: mdl-12201856

RESUMO

OBJECTIVES: The objective of this study was to understand the types of economic and quality-of-life promotional claims the FDA considers false or misleading. METHODS: Publicly available FDA letters (n = 569) sent to pharmaceutical companies from 1997 through 2001 for inappropriate promotional claims were reviewed. A standard data collection form was developed, including six categories for economic violations and three for QOL violations. For QOL, only letters with explicit violations for false or misleading claims using the words "quality of life" or patient "well-being" were considered. Other information collected included type of regulatory letter and media in which violations were found. RESULTS: Twenty-eight (4.9%) letters cited false and/or misleading economic claims. The most common economic violation was "unsupported comparative claim of effectiveness, safety, or interchangeability" (n = 14). Twenty-eight (4.9%) letters cited QOL violations, of which four contained both economic and QOL violations. The most common QOL violation was "lack of substantial evidence for QOL claims" (n = 15). None of the FDA letters used the term "patient reported outcomes." Violations were found most frequently in brochure and Web site-based promotions. CONCLUSIONS: The body of evidence that is emerging illustrates how the FDA is regulating promotional material containing misleading or unsubstantiated economic and QOL claims. However, knowing what constitutes an appropriate claim remains challenging because there are no formal guidelines describing what constitutes a violation, nor what level of substantiating evidence is required. More guidance may be needed to ensure appropriate use of these claims in drug promotions.


Assuntos
Publicidade/normas , Indústria Farmacêutica/normas , Fraude , United States Food and Drug Administration , Publicidade/legislação & jurisprudência , Indústria Farmacêutica/legislação & jurisprudência , Farmacoeconomia , Humanos , Qualidade de Vida , Resultado do Tratamento , Estados Unidos
17.
Med Care ; 40(9): 840-5, 2002 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-12218774

RESUMO

BACKGROUND: The extent to which pharmaceutical companies promote the economic advantages of their products in advertisements in medical journals, and whether such claims are supported by evidence, has not been quantified. Our objectives were to examine how often prescription drug advertisements in leading medical journals contain economic messages, and to determine the types of promotional claims made and whether supporting evidence is provided. METHODS: All prescription drug advertisements appearing in six leading general medical and specialty journals in 3 selected months annually from 1990 to 1999 were reviewed. Using a standard data collection form, two reviewers examined each ad for economic content-including mention of the drug's price, value, cost saving, or cost-effectiveness. RESULTS: Economic messages appeared in 237 (11.1%) of the 2144 advertisements examined. Proportion of ads with economic content has increased over time (P = 0.003). Most frequently, economic ads contained statements that drugs were "less expensive" or "cost less" than alternative treatments (50.6% of economic ads). Supporting evidence for economic claims was clearly reported in 63.7% of cases, and typically referred to published drug prices rather than more detailed economic analysis. Ads for calcium channel blocking agents and ACE inhibitors frequently contained economic messages. CONCLUSIONS: Economic messages about prescription drugs are used in advertisements in leading medical journals and their frequency may be rising. Physicians should be aware of this phenomenon, and its potential impact on their prescribing decisions. More scrutiny of the supporting evidence underlying economic claims by the medical community and regulators may be needed.


Assuntos
Publicidade , Publicações Periódicas como Assunto , Preparações Farmacêuticas/economia , Redução de Custos , Análise Custo-Benefício , Indústria Farmacêutica , Humanos
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