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1.
J Acad Consult Liaison Psychiatry ; 63(5): 497-510, 2022.
Artigo em Inglês | MEDLINE | ID: mdl-35618222

RESUMO

Suicide is a serious public health concern. On average, 80% of suicide decedents had contact with primary care within 1 year of their suicide. This and other research underscore the importance of screening for suicide risk within primary care settings, and implementation of suicide risk screening is already underway in many practices. However, while primary care practices may be familiar with screening for other mental health concerns (e.g., depression), many feel uncomfortable or unprepared for suicide risk screening. To meet the increasing demand for evidence-based suicide-risk-screening guidance, we provide a clinical pathway for adult primary care practices (to include family medicine, internal medicine, women's health). The pathway was developed by experts with research, clinical expertise, and experience in suicide risk screening and primary care. We also provide detailed guidance to aid primary care practices in their decisions about how to implement the clinical pathway.


Assuntos
Procedimentos Clínicos , Prevenção do Suicídio , Adulto , Feminino , Humanos , Programas de Rastreamento , Atenção Primária à Saúde , Registros
2.
Acad Pediatr ; 22(2): 217-226, 2022 03.
Artigo em Inglês | MEDLINE | ID: mdl-35248306

RESUMO

OBJECTIVE: To describe the methodological development and feasibility of real-world implementation of suicide risk screening into a pediatric primary care setting. METHODS: A suicide risk screening quality improvement project (QIP) was implemented by medical leadership from a suburban-based pediatric (ages 12-25 years) primary care practice in collaboration with a National Institute of Mental Health (NIMH) suicide prevention research team. A pilot phase to acclimate office staff to screening procedures preceded data collection. A convenience sample of 271 pediatric medical outpatients was screened for suicide risk. Patients, their parents, and medical staff reported their experiences and opinions of the screening procedures. RESULTS: Thirty-one (11.4%) patients screened positive for suicide risk, with 1 patient endorsing imminent suicide risk (3% of positive screens; 0.4% of total sample). Over half of the patients who screened positive reported a past suicide attempt. Most patients, parents, and medical staff supported the implementation of suicide risk screening procedures into standard care. A mental health clinical pathway for suicide risk screening in outpatient settings was developed to provide outpatient medical settings with guidance for screening. CONCLUSIONS: Screening for suicide risk in pediatric primary care is feasible and acceptable to patients, their families, and medical staff. A clinical pathway used as guidance for pediatric health care providers to implement screening programs can aid with efficiently detecting and managing patients who are at risk for suicide.


Assuntos
Programas de Rastreamento , Prevenção do Suicídio , Adolescente , Adulto , Criança , Suscetibilidade a Doenças , Humanos , Pacientes Ambulatoriais , Atenção Primária à Saúde , Melhoria de Qualidade , Adulto Jovem
5.
Prev Med ; 111: 299-306, 2018 06.
Artigo em Inglês | MEDLINE | ID: mdl-29155224

RESUMO

Accidents are a leading cause of deaths in U.S. active duty personnel. Understanding accident deaths during wartime could facilitate future operational planning and inform risk prevention efforts. This study expands prior research, identifying health risk factors associated with U.S. Army accident deaths during the Afghanistan and Iraq war. Military records for 2004-2009 enlisted, active duty, Regular Army soldiers were analyzed using logistic regression modeling to identify mental health, injury, and polypharmacy (multiple narcotic and/or psychotropic medications) predictors of accident deaths for current, previously, and never deployed groups. Deployed soldiers with anxiety diagnoses showed higher risk for accident deaths. Over half had anxiety diagnoses prior to being deployed, suggesting anticipatory anxiety or symptom recurrence may contribute to high risk. For previously deployed soldiers, traumatic brain injury (TBI) indicated higher risk. Two-thirds of these soldiers had first TBI medical-encounter while non-deployed, but mild, combat-related TBIs may have been undetected during deployments. Post-Traumatic Stress Disorder (PTSD) predicted higher risk for never deployed soldiers, as did polypharmacy which may relate to reasons for deployment ineligibility. Health risk predictors for Army accident deaths are identified and potential practice and policy implications discussed. Further research could test for replicability and expand models to include unobserved factors or modifiable mechanisms related to high risk. PTSD predicted high risk among those never deployed, suggesting importance of identification, treatment, and prevention of non-combat traumatic events. Finally, risk predictors overlapped with those identified for suicides, suggesting effective intervention might reduce both types of deaths.


Assuntos
Acidentes de Trabalho/mortalidade , Transtornos Mentais/diagnóstico , Militares/estatística & dados numéricos , Polimedicação , Ferimentos e Lesões , Acidentes de Trabalho/prevenção & controle , Adulto , Feminino , Humanos , Masculino , Medição de Risco , Fatores de Risco , Estados Unidos/epidemiologia
6.
JAMA Psychiatry ; 73(7): 741-9, 2016 07 01.
Artigo em Inglês | MEDLINE | ID: mdl-27224848

RESUMO

IMPORTANCE: Suicide attempts in the US Army have risen in the past decade. Understanding the association between suicide attempts and deployment, as well as method and timing of suicide attempts, can assist in developing interventions. OBJECTIVE: To examine suicide attempt risk factors, methods, and timing among soldiers currently deployed, previously deployed, and never deployed at the time this study was conducted. DESIGN, SETTING, AND PARTICIPANTS: This longitudinal, retrospective cohort study of Regular Army-enlisted soldiers on active duty from 2004 through 2009 used individual-level person-month records to examine risk factors (sociodemographic, service related, and mental health), method, and time of suicide attempt by deployment status (never, currently, and previously deployed). Administrative data for the month before each of 9650 incident suicide attempts and an equal-probability sample of 153 528 control person-months for other soldiers were analyzed using a discrete-time survival framework. MAIN OUTCOMES AND MEASURES: Suicide attempts and career, mental health, and demographic predictors were obtained from administrative and medical records. RESULTS: Of the 9650 enlisted soldiers who attempted suicide, 86.3% were male, 68.4% were younger than 30 years, 59.8% were non-Hispanic white, 76.5% were high school educated, and 54.7% were currently married. The 40.4% of enlisted soldiers who had never been deployed (n = 12 421 294 person-months) accounted for 61.1% of enlisted soldiers who attempted suicide (n = 5894 cases). Risk among those never deployed was highest in the second month of service (103 per 100 000 person-months). Risk among soldiers on their first deployment was highest in the sixth month of deployment (25 per 100 000 person-months). For those previously deployed, risk was highest at 5 months after return (40 per 100 000 person-months). Currently and previously deployed soldiers were more likely to attempt suicide with a firearm than those never deployed (currently deployed: OR, 4.0; 95% CI, 2.9-5.6; previously deployed: OR, 2.7; 95% CI, 1.8-3.9). Across deployment status, suicide attempts were more likely among soldiers who were women (currently deployed: OR, 3.4; 95% CI, 3.0-4.0; previously deployed: OR, 1.5; 95% CI, 1.4-1.7; and never deployed: OR, 2.4; 95% CI, 2.3-2.6), in their first 2 years of service (currently deployed: OR, 1.9; 95% CI, 1.5-2.3; previously deployed: OR, 2.2; 95% CI, 1.9-2.7; and never deployed: OR, 3.1; 95% CI, 2.7-3.6), and had a recently received a mental health diagnosis in the previous month (currently deployed: OR, 29.8; 95% CI, 25.0-35.5; previously deployed: OR, 22.2; 95% CI, 20.1-24.4; and never deployed: OR, 15.0; 95% CI, 14.2-16.0). Among soldiers with 1 previous deployment, odds of a suicide attempt were higher for those who screened positive for depression or posttraumatic stress disorder after return from deployment and particularly at follow-up screening, about 4 to 6 months after deployment (depression: OR, 1.4; 95% CI, 1.1-1.9; posttraumatic stress disorder: OR, 2.4; 95% CI, 2.1-2.8). CONCLUSIONS AND RELEVANCE: Identifying the timing and risk factors for suicide attempt in soldiers requires consideration of environmental context, individual characteristics, and mental health. These factors can inform prevention efforts.


Assuntos
Campanha Afegã de 2001- , Guerra do Iraque 2003-2011 , Militares/psicologia , Militares/estatística & dados numéricos , Tentativa de Suicídio/psicologia , Tentativa de Suicídio/estatística & dados numéricos , Adulto , Causas de Morte , Estudos Transversais , Transtorno Depressivo/epidemiologia , Transtorno Depressivo/prevenção & controle , Transtorno Depressivo/psicologia , Feminino , Humanos , Masculino , Programas de Rastreamento , Modelos de Riscos Proporcionais , Fatores de Risco , Transtornos de Estresse Pós-Traumáticos/epidemiologia , Transtornos de Estresse Pós-Traumáticos/prevenção & controle , Transtornos de Estresse Pós-Traumáticos/psicologia , Tentativa de Suicídio/prevenção & controle , Fatores de Tempo
7.
Int J Methods Psychiatr Res ; 22(4): 303-21, 2013 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-24318219

RESUMO

A clinical reappraisal study was carried out in conjunction with the Army Study to Assess Risk and Resilience in Servicemembers (Army STARRS) All-Army Study (AAS) to evaluate concordance of the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) diagnoses based on the Composite International Diagnostic Interview Screening Scales (CIDI-SC) and post-traumatic stress disorder (PTSD) checklist (PCL) with diagnoses based on independent clinical reappraisal interviews (Structured Clinical Interview for DSM-IV [SCID]). Diagnoses included: lifetime mania/hypomania, panic disorder, and intermittent explosive disorder; six-month adult attention-deficit/hyperactivity disorder; and 30-day major depressive episode, generalized anxiety disorder, PTSD, and substance (alcohol or drug) use disorder (abuse or dependence). The sample (n = 460) was weighted for over-sampling CIDI-SC/PCL screened positives. Diagnostic thresholds were set to equalize false positives and false negatives. Good individual-level concordance was found between CIDI-SC/PCL and SCID diagnoses at these thresholds (area under curve [AUC] = 0.69-0.79). AUC was considerably higher for continuous than dichotomous screening scale scores (AUC = 0.80-0.90), arguing for substantive analyses using not only dichotomous case designations but also continuous measures of predicted probabilities of clinical diagnoses.


Assuntos
Programas de Rastreamento , Transtornos Mentais/diagnóstico , Militares/psicologia , Resiliência Psicológica , Medição de Risco , Área Sob a Curva , Distribuição de Qui-Quadrado , Manual Diagnóstico e Estatístico de Transtornos Mentais , Feminino , Inquéritos Epidemiológicos , Humanos , Masculino , Transtornos Mentais/epidemiologia , Transtornos Mentais/psicologia , Militares/estatística & dados numéricos , Escalas de Graduação Psiquiátrica , Curva ROC , Estudos Retrospectivos
8.
Pediatrics ; 130(2): e380-9, 2012 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-22753553

RESUMO

OBJECTIVE: There is controversy about appropriate methods to reduce sudden cardiac death (SCD) in young athletes, but there is limited evidence on costs or consequences of alternative strategies. The objective of this study was to evaluate the cost-effectiveness of adding electrocardiogram (ECG) screening to the currently standard practice of preparticipation history and physical examination (H&P) to reduce SCD. METHODS: Decision analysis modeling by using a societal perspective, with annual Markov cycles from age 14 until death. Three screening strategies were evaluated: (1) H&P, with cardiology referral if abnormal (current standard practice); (2) H&P, plus ECG after negative H&P, and cardiology referral if either is abnormal; and (3) ECG only, with cardiology referral if abnormal. Children identified with SCD-associated cardiac abnormalities were restricted from sports and received cardiac treatment. Main outcome measures were costs of screening and treatment, quality-adjusted life years (QALYs), and premature deaths averted. RESULTS: Relative to strategy 1, incremental cost-effectiveness is $68800/QALY for strategy 2 and $37700/QALY for strategy 3. Monte Carlo simulation revealed the chance of incremental cost-effectiveness compared with strategy 1 was 30% for strategy 2 and 66% for strategy 3 (assumed willingness to pay ≤$50000/QALY). Compared with strategy 1, strategy 2 averted 131 additional SCDs at $900000 per case, and strategy 3 averted 127 SCDs at $600000 per case. CONCLUSIONS: Under a societal willingness to pay threshold of $50000/QALY, adding ECGs to current preparticipation evaluations for athletes is not cost-effective, with costs driven largely by false-positive findings.


Assuntos
Atletas , Morte Súbita Cardíaca/prevenção & controle , Eletrocardiografia/economia , Programas de Rastreamento/economia , Adolescente , Estudos de Casos e Controles , Criança , Análise Custo-Benefício , Técnicas de Apoio para a Decisão , Feminino , Humanos , Recém-Nascido , Masculino , Cadeias de Markov , Anamnese , Mortalidade Prematura , Exame Físico/economia , Anos de Vida Ajustados por Qualidade de Vida , Encaminhamento e Consulta/economia , Estados Unidos
9.
Circulation ; 121(11): 1329-37, 2010 Mar 23.
Artigo em Inglês | MEDLINE | ID: mdl-20212277

RESUMO

BACKGROUND: Stimulants are widely used to treat children with attention deficit/hyperactivity disorder and may increase the risk for sudden cardiac death (SCD). We examined the cost-effectiveness of pretreatment screening with ECG for reducing SCD risk in children diagnosed with attention deficit/hyperactivity disorder who are candidates for stimulant medication. Method and Results- We constructed a state-transition Markov model with 10 annual cycles spanning 7 to 17 years of age. Taking a societal perspective, we compared the cost-effectiveness of 3 screening strategies: (1) performing a history and physical examination with cardiology referral if abnormal (current standard of care); (2) performing a history and physical examination plus ECG after negative history and physical examination, with cardiology referral if either is abnormal; and (3) performing a history and physical examination plus ECG, with cardiology referral only if ECG is abnormal. Children identified with SCD-associated cardiac abnormalities would be restricted from stimulants and from playing competitive sports. The expected incremental cost-effectiveness over strategy 1 was $39,300 and $27,200 per quality-adjusted life-year for strategies 2 and 3, respectively. Monte Carlo simulation found that the chance of incremental cost-effectiveness was 55% for strategy 2 and 71% for strategy 3 (willingness to pay < or =$50,000 per quality-adjusted life-year). Both strategies 2 and 3 would avert 13 SCDs per 400,000 children seeking stimulant treatment for ADHD, for a cost of $1.6 million per life for strategy 2 and $1.2 million per life for strategy 3. CONCLUSIONS: Relative to current practice, adding ECG screening to history and physical examination pretreatment screening for children with attention deficit/hyperactivity disorder has borderline cost-effectiveness for preventing SCD. Relative cost-effectiveness may be improved by basing cardiology referral on ECG alone. Benefits of ECG screening arise primarily by restricting children identified with SCD risk from competitive sports.


Assuntos
Transtorno do Deficit de Atenção com Hiperatividade/tratamento farmacológico , Morte Súbita Cardíaca/prevenção & controle , Programas de Rastreamento/economia , Programas de Rastreamento/métodos , Modelos Estatísticos , Adolescente , Criança , Análise Custo-Benefício , Morte Súbita Cardíaca/epidemiologia , Eletrocardiografia , Feminino , Humanos , Incidência , Masculino , Cadeias de Markov , Anamnese , Exame Físico , Anos de Vida Ajustados por Qualidade de Vida , Fatores de Risco , Estados Unidos/epidemiologia
10.
Am J Manag Care ; 14(8): 497-504, 2008 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-18690765

RESUMO

OBJECTIVE: To determine optimal methods of identifying enrollees with possible depression for additional depression screening in the context of a care management program for chronically ill Medicare recipients. STUDY DESIGN: Observational analysis of telephone and mail survey and claims data collected for the Medicare Health Support (MHS) program. METHODS: This study examines data from 14,902 participants with diabetes mellitus and/or congestive heart failure in the MHS program administered by Green Ribbon Health, LLC. Depression screening was performed by administering a 2-item screen (the Patient Health Questionnaire 2 [PHQ-2]) by telephone or by mail. Additional information about possible depression was drawn from International Classification of Diseases, Ninth Revision (ICD-9) depression diagnoses on claims and from self-reported use of antidepressant medications. We evaluated positive depression screens using the PHQ-2 administered via telephone versus mail, examined variations in screener-positive findings by care manager, and compared rates of positive screens with antidepressant use and with claims diagnoses of depression. RESULTS: Almost 14% of participants received an ICD-9 diagnosis of depression during the year before program enrollment; 7.1% reported taking antidepressants, and 5.1% screened positive for depression on the PHQ-2. We found substantial variation in positive depression screens by care manager that could not be explained by case mix, prior depression diagnoses, or current depression treatment. After adjusting for demographic and clinical differences, the PHQ-2-positive screen rates were 6.5% by telephone and 14.1% by mail (P <.001). CONCLUSION: A multipronged effort composed of mail screening (using the PHQ-2), self-reported antidepressant use, and claims diagnoses of depression may capture the greatest number of enrollees with possible depression.


Assuntos
Transtorno Depressivo/diagnóstico , Gerenciamento Clínico , Programas de Rastreamento/métodos , Medicare Part D/estatística & dados numéricos , Idoso , Idoso de 80 Anos ou mais , Antidepressivos/economia , Antidepressivos/uso terapêutico , Doença Crônica , Comorbidade , Transtorno Depressivo/tratamento farmacológico , Transtorno Depressivo/epidemiologia , Complicações do Diabetes/economia , Complicações do Diabetes/psicologia , Planos de Pagamento por Serviço Prestado , Feminino , Florida , Pesquisas sobre Atenção à Saúde , Insuficiência Cardíaca/complicações , Insuficiência Cardíaca/economia , Insuficiência Cardíaca/psicologia , Humanos , Revisão da Utilização de Seguros , Masculino , Programas de Assistência Gerenciada , Programas de Rastreamento/economia , Cooperação do Paciente , Estados Unidos
11.
J Gen Intern Med ; 23(10): 1571-5, 2008 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-18649108

RESUMO

OBJECTIVE: To assess whether Medicare fee-for-service beneficiaries with depression and diabetes had a higher mortality rate over a 2-year period compared with beneficiaries with diabetes alone. DESIGN: Evidence of depression was based on a physician diagnosis or self-reported prescription of an antidepressant in the year prior to screening, or a score of > or = 3 on the Patient Health Questionnaire two-item questionnaire. Mortality was assessed bi-monthly by checking Medicare claims and eligibility files or from information from telephone contact with the participant's family. Cox proportional hazard regression models were used to calculate adjusted hazard ratios of death in depressed versus nondepressed beneficiaries with diabetes. PARTICIPANTS: A total of 10,704 beneficiaries with diabetes enrolled in a disease management program were surveyed with a health assessment questionnaire and followed over a two-year period. MAIN RESULTS: Comorbid depression in Medicare beneficiaries with diabetes participating in a disease management program was associated with an increased risk for all-cause mortality over a two-year period of approximately 36% to 38%, depending on the definition of depression that was used. No significant increase in rates of cause-specific mortality from macrovascular disease were found in depressed versus nondepressed beneficiaries. CONCLUSION: Among a large Medicare cohort of fee-for-service beneficiaries with diabetes, comorbid depression was associated with an increase in all-cause mortality over a two-year period. Future research will be required to determine whether the increase in mortality associated with depression is due to potential behavioral mediators (i.e., smoking, poor adherence to diet) or physiologic abnormalities (i.e., hypothalamic-pituitary axis dysregulation) associated with depression.


Assuntos
Transtorno Depressivo/mortalidade , Transtorno Depressivo/psicologia , Complicações do Diabetes/mortalidade , Complicações do Diabetes/psicologia , Idoso , Antidepressivos/uso terapêutico , Transtorno Depressivo/complicações , Transtorno Depressivo/terapia , Complicações do Diabetes/terapia , Feminino , Florida , Insuficiência Cardíaca/complicações , Insuficiência Cardíaca/mortalidade , Insuficiência Cardíaca/psicologia , Insuficiência Cardíaca/terapia , Humanos , Masculino , Medicare/tendências , Fatores de Risco , Taxa de Sobrevida/tendências , Estados Unidos
12.
Am J Prev Med ; 28(3): 274-80, 2005 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-15766615

RESUMO

BACKGROUND: Whether current and potential smokers recognize the full scope of smoking-related risks remains in dispute. This paper provides new evidence for one key group, teenagers, by assessing whether teens accurately assess the chances that they will be smoking in the future. Among current smokers, this is one measure of whether they understand the addictiveness of smoking. Among current nonsmokers, this provides evidence regarding the social environment in which teens decide whether to smoke. METHODS: A nationally representative sample of teens was asked to assess the chances that they would be smoking 1 year later. Mean expectations of future smoking were compared with the actual probabilities of smoking initiation or continuation over 1 year from comparable epidemiologic data. RESULTS: Among current smokers, the mean expectation of continued smoking in 1 year was significantly lower than the observed continuation rate (p <0.01). Among nonsmoking teens, the mean expectation of smoking initiation was significantly lower than the observed rate of initiation (p <0.02). Both types of underestimations were substantively large and consistent across the teenage years. CONCLUSIONS: Currently-smoking teens underestimate the chances that they will continue smoking--which is one measure of whether they understand the addictiveness of cigarettes--while currently-nonsmoking teens underestimate the chance that they will start to smoke, a measure of the social appeal of cigarettes. Tobacco control strategies should account for these misperceptions.


Assuntos
Previsões , Fumar/psicologia , Adolescente , Adulto , Atitude Frente a Saúde , Estudos Transversais , Feminino , Humanos , Masculino , Reprodutibilidade dos Testes , Fumar/epidemiologia , Fumar/tendências
13.
Arch Gen Psychiatry ; 61(4): 378-86, 2004 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-15066896

RESUMO

BACKGROUND: Quality improvement (QI) programs for depressed primary care patients can improve health outcomes for 6 to 28 months; effects for longer than 28 months are unknown. OBJECTIVE: To assess how QI for depression affects health outcomes, quality of care, and health outcome disparities at 57-month follow-up. DESIGN: A group-level randomized controlled trial. SETTING: Forty-six primary care practices in 6 managed care organizations. PATIENTS: Of 1356 primary care patients who screened positive for depression and enrolled in the trial, 991 (73%, including 451 Latinos and African Americans) completed 57-month telephone follow-up. INTERVENTIONS: Clinics were randomly assigned to usual care or to 1 of 2 QI programs supporting QI teams, provider training, nurse assessment, and patient education, plus resources to support medication management (QI-meds) or psychotherapy (QI-therapy) for 6 to 12 months. MAIN OUTCOME MEASURES: Probable depressive disorder in the previous 6 months, mental health-related quality of life in the previous 30 days, primary care or mental health specialty visits, counseling or antidepressant medications in the previous 6 months, and unmet need, defined as depressed but not receiving appropriate care. RESULTS: Combined QI-meds and QI-therapy, relative to usual care, reduced the percentage of participants with probable disorder at 5 years by 6.6 percentage points (P =.04). QI-therapy improved health outcomes and reduced unmet need for appropriate care among Latinos and African Americans combined but provided few long-term benefits among whites, reducing outcome disparities related to usual care (P =.04 for QI-ethnicity interaction for probable depressive disorder). CONCLUSIONS: Programs for QI for depressed primary care patients implemented by managed care practices can improve health outcomes 5 years after implementation and reduce health outcome disparities by markedly improving health outcomes and unmet need for appropriate care among Latinos and African Americans relative to whites; thus, equity was improved in the long run.


Assuntos
Transtorno Depressivo/terapia , Atenção Primária à Saúde/normas , Garantia da Qualidade dos Cuidados de Saúde , Adulto , Educação Médica Continuada , Educação Continuada em Enfermagem , Feminino , Humanos , Masculino , Programas de Rastreamento , Pessoa de Meia-Idade , Educação de Pacientes como Assunto , Gestão da Qualidade Total
14.
JAMA ; 289(22): 2970-7, 2003 Jun 11.
Artigo em Inglês | MEDLINE | ID: mdl-12799405

RESUMO

CONTEXT: Concern about additional costs for direct patient care impedes efforts to enroll patients in clinical trials. But generalizable evidence substantiating these concerns is lacking. OBJECTIVE: To assess the additional cost of treating cancer patients in the National Cancer Institute (NCI)-sponsored clinical trials in the United States across a range of trial phases, treatment modalities, and patient care settings. DESIGN: Retrospective cost study using a multistage, stratified, random sample of patients enrolled in 1 of 35 active phase 3 trials or phase 1 or any phase 2 trials between October 1, 1998, and December 31, 1999. Unadjusted and adjusted costs were compared and related to trial phase, institution type, and vital status. SETTING AND PARTICIPANTS: A representative sample of 932 cancer patients enrolled in nonpediatric, NCI-sponsored clinical trials and 696 nonparticipants with a similar stage of disease not enrolled in a research protocol from 83 cancer clinical research institutions across the United States. MAIN OUTCOME MEASURES: Direct treatment costs as measured using a combination of medical records, telephone survey, and Medicare claims data. Administrative and other research costs were excluded. RESULTS: The incremental costs of direct care in trials were modest. Over approximately a 2.5-year period, adjusted costs were 6.5% higher for trial participants than nonparticipants (35,418 dollars vs 33,248 dollars; P =.11). Cost differences for phase 3 studies were 3.5% (P =.22), lower than for phase 1 or 2 trials (12.8%; P =.20). Trial participants who died had higher costs than nonparticipants who died (17.9%; 39,420 dollars vs 33,432 dollars, respectively; P =.15). CONCLUSIONS: Treatment costs for nonpediatric clinical trial participants are on average 6.5% higher than what they would be if patients did not enroll. This implies total incremental treatment costs for NCI-sponsored trials of 16 million dollars in 1999. Incremental costs were higher for patients who died and who were in early phase studies although these findings deserve further scrutiny. Overall, the additional treatment costs of an open reimbursement policy for government-sponsored cancer clinical trials appear minimal.


Assuntos
Ensaios Clínicos como Assunto/economia , Custos de Cuidados de Saúde , Neoplasias/terapia , Apoio à Pesquisa como Assunto/economia , Adulto , Humanos , Reembolso de Seguro de Saúde , National Institutes of Health (U.S.) , Neoplasias/economia , Estudos Retrospectivos , Estados Unidos
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