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1.
J Geriatr Oncol ; 14(7): 101586, 2023 09.
Artigo em Inglês | MEDLINE | ID: mdl-37459767

RESUMO

INTRODUCTION: Geriatric assessment and management (GAM) is recommended by professional organizations and recently several randomized controlled trials (RCTs) demonstrated benefits in multiple health outcomes. GAM typically leads to one or more recommendations for the older adult on how to optimize their health. However, little is known about how well recommendations are adhered to. Understanding these issues is vital to designing GAM trials and clinical programs. Therefore, the aim of this study was to examine the number of GAM recommendations made and adherence to and satisfaction with the intervention in a multicentre RCT of GAM for older adults with cancer. MATERIALS AND METHODS: The 5C study was a two-group parallel RCT conducted in eight hospitals across Canada. Each centre kept a detailed recruitment and retention log. The intervention teams documented adherence to their recommendations. Medical records were also reviewed to assess which recommendations were adhered to. Twenty-three semi-structured interviews were conducted with 12 members of the intervention teams and 11 oncology team members to assess implementation of the study and the intervention. RESULTS: Of the 350 participants who were enrolled, 173 were randomized to the intervention arm. Median number of recommendations was seven. Mean adherence to recommendations based on the GAM was 69%, but it varied by type of recommendation, ranging from 98% for laboratory tests to 28% for psychosocial/psychiatry oncology referrals. There was no difference in the number of recommendations or non-adherence to recommendations by sex, level of frailty, or functional status. Oncologists and intervention team members were satisfied with the study implementation and intervention delivery. DISCUSSION: Adherence to recommendations was variable. Adherence to laboratory investigations and further imaging were generally high but much lower for recommendations regarding psychosocial support. Further collaborative work with older adults with cancer is needed to understand how to optimize the intervention to be consistent with patient goals, priorities, and values to ensure maximal impact on health outcomes.


Assuntos
Fragilidade , Neoplasias , Humanos , Idoso , Avaliação Geriátrica , Canadá , Neoplasias/terapia , Satisfação Pessoal , Ensaios Clínicos Controlados Aleatórios como Assunto
2.
J Geriatr Oncol ; 14(1): 101384, 2023 01.
Artigo em Inglês | MEDLINE | ID: mdl-36216760

RESUMO

INTRODUCTION: Geriatric assessment (GA) provides information on key health domains of older adults and is recommended to help inform cancer treatment decisions and cancer care. However, GA is not feasible in many health institutions due to lack of geriatric staff and/or resources. To increase accessibility to GA and improve treatment decision making for older adults with cancer (≥65 years), we developed a self-reported, electronic geriatric assessment tool: Comprehensive Assessment for My Plan (CHAMP). MATERIALS AND METHODS: Older adults with cancer were invited to join user-centered design sessions to develop the layout and content of the tool. Subsequently, they participated in usability testing to test the usability of the tool (ease of use, acceptability, etc.). Design sessions were also conducted with oncology clinicians (oncologists and nurses) to develop the tool's clinician interface. GA assessment questions and GA recommendations were guided by a systematic review and Delphi expert panel. RESULTS: A total of seventeen older adults participated in the study. Participants were mainly males (82.4%) and 75% were aged 75 years and older. Nine oncology clinicians participated in design sessions. Older adults and clinicians agreed that the tool was user-friendly. Domains in the final CHAMP tool (with questions and recommendations) included functional status, falls risk, cognitive impairment, nutrition, medication review, social supports, depression, substance use disorder, and miscellaneous items. DISCUSSION: CHAMP was designed for use by older adults and oncologists and may enhance access to GA for older adults with cancer. The next phase of the CHAMP study will involve field validation in oncology clinics.


Assuntos
Avaliação Geriátrica , Neoplasias , Idoso , Masculino , Humanos , Feminino , Neoplasias/terapia , Oncologia , Autorrelato
3.
J Clin Oncol ; 41(4): 847-858, 2023 02 01.
Artigo em Inglês | MEDLINE | ID: mdl-36473126

RESUMO

PURPOSE: American Society of Clinical Oncology recommends that older adults with cancer being considered for chemotherapy receive geriatric assessment (GA) and management (GAM), but few randomized controlled trials have examined its impact on quality of life (QOL). PATIENTS AND METHODS: The 5C study was a two-group parallel 1:1 single-blind multicenter randomized controlled trial of GAM for 6 months versus usual oncologic care. Eligible patients were age 70+ years, diagnosed with a solid tumor, lymphoma, or myeloma, referred for first-/second-line chemotherapy or immunotherapy or targeted therapy, and had an Eastern Cooperative Oncology Group performance status of 0-2. The primary outcome QOL was measured with the global health scale of the European Organisation for the Research and Treatment of Cancer QOL questionnaire and analyzed with a pattern mixture model using an intent-to-treat approach (at 6 and 12 months). Secondary outcomes included functional status, grade 3-5 treatment toxicity; health care use; satisfaction; cancer treatment plan modification; and overall survival. RESULTS: From March 2018 to March 2020, 350 participants were enrolled. Mean age was 76 years and 40.3% were female. Fifty-four percent started treatment with palliative intent. Eighty-one (23.1%) patients died. GAM did not improve QOL (global QOL of 4.4 points [95% CI, 0.9 to 8.0] favoring the control arm). There was also no difference in survival, change in treatment plan, unplanned hospitalization/emergency department visits, and treatment toxicity between groups. CONCLUSION: GAM did not improve QOL. Most intervention group participants received GA on or after treatment initiation per patient request. Considering recent completed trials, GA may have benefit if completed before treatment selection. The COVID-19 pandemic may have affected our QOL outcome and intervention delivery for some participants.


Assuntos
COVID-19 , Neoplasias , Humanos , Feminino , Idoso , Masculino , Qualidade de Vida , Avaliação Geriátrica , Método Simples-Cego , Pandemias , Neoplasias/tratamento farmacológico , Hospitalização , Ensaios Clínicos Controlados Aleatórios como Assunto
4.
Oral Oncol ; 109: 104865, 2020 Jul 14.
Artigo em Inglês | MEDLINE | ID: mdl-32679542

RESUMO

OBJECTIVES: Sexual health problems have been identified as an unmet need in head and neck cancer (HNC) survivors. In particular, little is known about such outcomes in survivors of nasopharyngeal cancer (NPC). MATERIALS AND METHODS: A cross-sectional study of NPC survivors with ≥4y follow-up was undertaken. Sexual satisfaction was assessed using the optional "I am satisfied with my sex life" item of the FACT-H&N. Other patient-reported outcomes measures were also captured including fatigue (FACIT-F), HNC symptom burden (MDASI-HN), emotional distress (HADS) and frontal function (FrSBE). Univariate and multivariate analyses were performed to determine factors influencing sexual satisfaction. RESULTS: The sexual satisfaction item was answered by 85/103 (83%) enrollees. Female (p < 0.001) and non-partnered (p = 0.0045) patients were more likely to abstain from answering. The distribution of responses were: "very much" (26%), "quite a bit" (21%), "somewhat" (20%), "a little bit" (13%) and "not at all" (20%). Sexual satisfaction was associated with multiple patient-reported measures on univariate analysis, including quality of life, fatigue, a priori selected HNC symptoms (pain, taste), emotional distress, frontal lobe function, body image and relationship strength. On multivariate analysis, only relationship strength and emotional distress remained significant. Sociodemographic factors (age, sex, marital status) and other selected orofacial toxicities were not significant. CONCLUSIONS: Nearly half (47%) of our sample reported being in the higher satisfaction range. While reassuring in the context of comparative population level data, a number of factors including toxicity, psychological and social factors were associated with sexual satisfaction responses. Prospective evaluation of this unmet need is required.

5.
BMJ Open ; 9(5): e024485, 2019 05 10.
Artigo em Inglês | MEDLINE | ID: mdl-31079079

RESUMO

INTRODUCTION: Geriatric assessment and management is recommended for older adults with cancer referred for chemotherapy but no randomised controlled trial has been completed of this intervention in the oncology setting. TRIAL DESIGN: A two-group parallel single blind multi-centre randomised trial with a companion trial-based economic evaluation from both payer and societal perspectives with process evaluation. PARTICIPANTS: A total of 350 participants aged 70+, diagnosed with a solid tumour, lymphoma or myeloma, referred for first/second line chemotherapy, who speak English/French, have an Eastern Collaborative Oncology Group Performance Status 0-2 will be recruited. All participants will be followed for 12 months. INTERVENTION: Geriatric assessment and management for 6 months. The control group will receive usual oncologic care. All participants will receive a monthly healthy ageing booklet for 6 months. OBJECTIVE: To study the clinical and cost-effectiveness of geriatric assessment and management in optimising outcomes compared with usual oncology care. RANDOMISATION: Participants will be allocated to one of the two arms in a 1:1 ratio. The randomisation will be stratified by centre and treatment intent (palliative vs other). OUTCOME: Quality of life. SECONDARY OUTCOMES: (1) Cost-effectiveness, (2) functional status, (3) number of geriatric issues successfully addressed, (4) grades3-5 treatment toxicity, (5) healthcare use, (6) satisfaction, (7) cancer treatment plan modification and (8) overall survival. PLANNED ANALYSIS: For the primary outcome we will use a pattern mixture model using an intent-to-treat approach (at 3, 6 and12 months). We will conduct a cost-utility analysis alongside this clinical trial. For secondary outcomes 2-4, we will use a variety of methods. ETHICS AND DISSEMINATION: Our study has been approved by all required REBs. We will disseminate our findings to stakeholders locally, nationally and internationally and by publishing the findings. TRIAL REGISTRATION NUMBER: NCT03154671.


Assuntos
Avaliação Geriátrica , Neoplasias/terapia , Idoso , Antineoplásicos/efeitos adversos , Antineoplásicos/uso terapêutico , Canadá , Análise Custo-Benefício , Avaliação Geriátrica/métodos , Humanos , Neoplasias/tratamento farmacológico , Neoplasias/economia , Método Simples-Cego , Resultado do Tratamento
6.
Cancer Med ; 8(4): 1584-1593, 2019 04.
Artigo em Inglês | MEDLINE | ID: mdl-30848108

RESUMO

BACKGROUND: The cost of new anticancer drugs is rising. We aimed to assess the clinical benefit and price of anti-cancer drugs approved by the US Food and Drug Administration (FDA) for advanced gastrointestinal cancers. METHODS: Drugs approved between 2006 and 2017 for advanced GI malignancies were identified from FDA.gov, and their updated supporting trial data were searched. Incremental clinical benefit was quantified by using ESMO Magnitude of Clinical Benefit Scale version 1.1 (grade 0-5) and ASCO Value Framework version 2 (score range -20 to 180). Higher scores indicate larger net benefit, and substantial benefit was defined as score 4 or 5 by the European Society for Medical Oncology (ESMO). The Micromedex REDBOOK was used to estimate the monthly average wholesale price (AWP) and total drug price (TDP) over the median treatment duration per patient. Clinical benefit, AWP and TDP of each drug class were assessed. RESULTS: In total, 16 GI cancer drugs received FDA approval for 24 indications, including five monoclonal antibodies (mAbs), five oral targeted therapies (TT), two immunotherapeutics (IO), three cytotoxic chemotherapies (CT), and one recombinant fusion protein (aflibercept). Most supporting trials (82%) reported overall survival benefit of less than 3 months and no significant improvement in quality of life. Only five agents (including one TT and one IO) with 21% the of approved indications met the ESMO's threshold of substantial clinical benefit. Median incremental benefit scores of TT and IO were comparable to other drug classes. However their median TDP was much higher at $153 402 and $98 208, respectively, compared to $30 330 USD per patient for CT. The estimated TDP did not correlate with clinical benefit scores. CONCLUSION: Most FDA-approved gastrointestinal cancer drugs do not meet the ESMO threshold of substantial clinical benefit. TT and IO are estimated to carry significant drug costs, and further cost analysis of these drugs is urgently needed.


Assuntos
Antineoplásicos , Aprovação de Drogas , Antineoplásicos/economia , Antineoplásicos/farmacologia , Antineoplásicos/uso terapêutico , Análise Custo-Benefício , Aprovação de Drogas/história , Aprovação de Drogas/estatística & dados numéricos , Custos de Medicamentos , Neoplasias Gastrointestinais/diagnóstico , Neoplasias Gastrointestinais/tratamento farmacológico , História do Século XXI , Humanos , Imunoterapia , Terapia de Alvo Molecular , Resultado do Tratamento , Estados Unidos , United States Food and Drug Administration
7.
J Geriatr Oncol ; 10(1): 169-174, 2019 01.
Artigo em Inglês | MEDLINE | ID: mdl-30041978

RESUMO

PURPOSE: Geriatric Assessment (GA) can help uncover previously unknown health issues and recommend tailored interventions to optimize outcomes; however, no completed randomized trial has examined the impact of GA on utility-based health status, healthcare use, and oncologists' opinions about GA. We examined these secondary outcomes of a randomized phase II trial. METHODS: A planned analysis of secondary outcomes of a two-group parallel single-blind randomized phase II trial of GA (ClinicalTrials.gov Identifier:NCT02222259) recruited patients ≥ age 70, diagnosed with stage II-IV breast/gastrointestinal/genitourinary cancer within six weeks of beginning chemotherapy at the Princess Margaret Cancer Centre, Toronto, Canada. Descriptive analyses using intent-to-treat were conducted for health status (EuroQol EQ-5D-3L) and healthcare utilization (patient self-report). Oncologist opinions were captured via open-ended interviews and summarized. RESULTS: A total of 95 patients who met the inclusion criteria were approached; 61 of them consented (64%). For health status, at all time-points, there were no significant differences between the two groups. The number of emergency department and family physician visits was low overall; there were no statistically significant differences between the two groups at any time point. All interviewed oncologists (eight of fourteen invited) were satisfied with the intervention, but wanted more straightforward recommendations and earlier GA results. CONCLUSIONS: No difference was found in terms of relationships between GA and utility-based health status or GA and healthcare use. Underreporting of healthcare use was possible. Oncologists welcome GA feedback and prefer to receive it in pre-treatment decision context. Larger trials with earlier GA are warranted.


Assuntos
Serviço Hospitalar de Emergência/estatística & dados numéricos , Avaliação Geriátrica/métodos , Neoplasias/diagnóstico , Aceitação pelo Paciente de Cuidados de Saúde/estatística & dados numéricos , Idoso , Idoso de 80 Anos ou mais , Retroalimentação , Feminino , Nível de Saúde , Humanos , Masculino , Oncologia/métodos , Neoplasias/complicações , Neoplasias/terapia , Método Simples-Cego
8.
Support Care Cancer ; 26(1): 109-117, 2018 01.
Artigo em Inglês | MEDLINE | ID: mdl-28741175

RESUMO

PURPOSE: Geriatric assessment and management (GAM) can identify current health issues and recommend interventions to optimize well-being of older adults, but no randomized trial has yet been completed in oncology. Therefore, a randomized phase 2 trial was conducted. METHODS: A two-group parallel single-blinded randomized phase II trial ( ClinicalTrials.gov Identifier: NCT02222259) enrolled patients aged ≥70 years, diagnosed with stage 2-4 gastrointestinal, genitourinary, or breast cancer within 6 weeks of commencing chemotherapy at Princess Margaret Cancer Centre. The coprimary feasibility outcomes were the proportion of eligible patients enrolled and retained. The coprimary clinical outcomes were quality of life (QOL) (EORTC QLQ C30) and modification of cancer treatment. Descriptive and regression analyses using intent-to-treat analysis were conducted. RESULTS: Sixty-one persons (64%) agreed to participate (31 allocated to intervention arm and 30 to control group). In the control group, more participants died and refused follow-up. The benefit of intervention over control on QOL at 3 months was greater for those who survived 6 months (difference 9.28; 95% CI -10.35 to 28.91) versus those who survived only 3 months (difference 6.55; 95% CI -9.63 to 22.73). CONCLUSIONS: This trial showed that it was feasible to recruit and retain older adults for a GAM study. Those who survived at least 6 months seemed to receive a greater QOL benefit than those who died or withdrew.


Assuntos
Avaliação Geriátrica/métodos , Neoplasias/terapia , Qualidade de Vida/psicologia , Idoso , Feminino , Humanos , Neoplasias/patologia
9.
Am J Hosp Palliat Care ; 30(5): 425-31, 2013 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-22777408

RESUMO

Home care (HC) is important for patients with cancer as performance status declines. Our study of 1224 patients at a Canadian cancer center examined the impact of an oncology palliative care clinic (OPCC) on HC referral. The HC referral frequency was calculated before and after the first OPCC consultation, in total and according to performance status (Palliative Performance Scale, PPS). Characteristics associated with HC referral were investigated. After the first OPCC consultation, there was an increase in HC referral from 39% (477 of 1224; 49% of those with PPS ≤60) to 69% (841 of 1224; 88% of those with PPS ≤60). Factors independently associated with HC referral were poor PPS (P < .001) and older age (P = .003). Thus OPCC involvement resulted in markedly increased HC referrals, particularly for older patients with poor performance status.


Assuntos
Acessibilidade aos Serviços de Saúde/estatística & dados numéricos , Serviços de Assistência Domiciliar/provisão & distribuição , Neoplasias/terapia , Cuidados Paliativos/estatística & dados numéricos , Adulto , Idoso , Idoso de 80 Anos ou mais , Feminino , Acessibilidade aos Serviços de Saúde/organização & administração , Serviços de Assistência Domiciliar/estatística & dados numéricos , Humanos , Masculino , Pessoa de Meia-Idade , Ontário/epidemiologia , Cuidados Paliativos/organização & administração , Encaminhamento e Consulta/estatística & dados numéricos , Adulto Jovem
10.
Value Health ; 11(3): 416-23, 2008.
Artigo em Inglês | MEDLINE | ID: mdl-18179673

RESUMO

OBJECTIVES: This study measured the treatment cost of bipolar disorder (BPD), decomposed the cost into that portion which was directly BPD-related and that attributable to comorbidities, and compared health-care utilization and costs across groups of patients with different drug regimens. METHODS: Using a multistate managed-care-organization claims database, a cohort of 67,862 BPD patients were selected and followed for the length of their enrollment between January 1, 1998 and December 31, 2002. All costs associated with the patients' medical claims were adjusted to 2002 dollars using the medical component of Consumer Price Index. Patients were classified into three groups based on their drug regimen: atypical antipsychotics (ATYP), atypical antipsychotics plus mood stabilizers (ATYP + MS), and mood stabilizers only (MS). The Charlson comorbidity index was used to control for comorbid conditions. Using both Poisson and log-linear regression analyses, numbers of hospitalizations, emergency room (ER) visits, and outpatient visits, as well as treatment costs per enrolled month, were regressed on age, sex, medication regimen, and clinical comorbidities. RESULTS: The mean charge and reimbursement per patient-year were $12,797 and $6581, respectively. Of the treatment cost, 33% was BPD-related, and 67% was attributed to comorbidities. Compared to patients in the MS treatment regimen, higher treatment costs were associated with ATYP (Rate Ratio = 1.24, 95% CI 1.17-1.31) and ATYP + MS (RR = 1.52, 1.47-1.56). Moreover, higher costs were associated with key comorbidities like personality disorder (RR = 1.45, 1.37-1.53). Patients on the ATYP regimen had higher risks of hospitalization (RR = 1.44, 1.33-1.56) and ER visits (RR = 1.15, 1.04-1.27), but lower risk of outpatient visits (RR = 0.81, 0.76-0.86). CONCLUSIONS: Controlling treatment costs for BPD patients requires focusing on patients with key comorbidities and monitoring the association between treatment regimen and resource use.


Assuntos
Transtorno Bipolar/economia , Custos de Cuidados de Saúde/estatística & dados numéricos , Adolescente , Adulto , Assistência Ambulatorial , Antimaníacos/economia , Antimaníacos/uso terapêutico , Transtorno Bipolar/tratamento farmacológico , Transtorno Bipolar/epidemiologia , Criança , Comorbidade , Custos e Análise de Custo , Custos de Medicamentos/estatística & dados numéricos , Feminino , Hospitalização/economia , Humanos , Modelos Lineares , Masculino , Programas de Assistência Gerenciada/economia , Pessoa de Meia-Idade , Distribuição de Poisson , Estudos Retrospectivos , Estados Unidos/epidemiologia , Revisão da Utilização de Recursos de Saúde
11.
Pharmacotherapy ; 27(1): 27-35, 2007 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-17192159

RESUMO

STUDY OBJECTIVE: To quantify the risk of diabetes mellitus associated with atypical antipsychotics compared with conventional antipsychotics in managed care Medicaid patients with bipolar disorder. DESIGN: Retrospective nested case-control study. DATA SOURCE: Integrated seven-state Medicaid managed care claims database from January 1, 1998-December 31, 2002. PATIENTS: Two hundred eighty-three patients with diabetes (cases) and 1134 controls matched by age, sex, and the index date on which bipolar disorder was diagnosed. MEASUREMENTS AND MAIN RESULTS: Cases were defined as those having an International Classification of Diseases, Ninth Revision diagnosis of diabetes or those receiving treatment with antidiabetic drugs. Both case and control patients had at least a 3-month exposure to either conventional or atypical antipsychotic agents or three filled prescriptions related to treatment for bipolar disorder. Of the 283 cases, 139 (49%) received atypical antipsychotics (olanzapine, risperidone, quetiapine, ziprasidone, and clozapine) and 133 (47%) were prescribed conventional antipsychotics. To compare the risk for new-onset diabetes associated with atypical versus conventional antipsychotics, we conducted a Cox proportional hazard regression, in which we controlled for age; sex; duration of bipolar disorder follow-up; use of lithium, anticonvulsants, antidepressants, and other drugs; and psychiatric and medical comorbidities. Compared with patients receiving conventional antipsychotics, the risk of diabetes was greatest among patients taking risperidone (hazard ratio [HR] 3.8, 95% confidence interval [CI] 2.7-5.3), olanzapine (3.7, 95% CI 2.5-5.3), and quetiapine (2.5, 95% CI 1.4-4.3). The risk for developing diabetes was also associated with weight gain (HR 2.5, 95% CI 1.9-3.4), hypertension (HR 1.6, 95% CI 1.2-2.2), and substance abuse (HR 1.5, 95% CI 1.0-2.2). CONCLUSION: Olanzapine, risperidone, and quetiapine are all associated with development or exacerbation of diabetes mellitus in patients with bipolar disorder. When prescribing therapy for this patient population, metabolic complications such as diabetes, weight gain, and hypertension need to be considered.


Assuntos
Antipsicóticos/uso terapêutico , Transtorno Bipolar/tratamento farmacológico , Diabetes Mellitus/epidemiologia , Adolescente , Adulto , Estudos de Casos e Controles , Criança , Diabetes Mellitus/etiologia , Feminino , Humanos , Masculino , Medicaid , Pessoa de Meia-Idade , Fatores de Risco
12.
J Clin Psychiatry ; 67(7): 1055-61, 2006 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-16889448

RESUMO

BACKGROUND: Drug-induced diabetes onset has not been adequately quantified in patients with bipolar disorder, although atypical antipsychotics have been widely used as new mood stabilizers. OBJECTIVES: To quantify the association between atypical antipsychotics and diabetes mellitus. METHOD: A retrospective, population-based, case-control study was conducted using the medical claims database from U.S. managed care organizations from January 1, 1998, to December 31, 2002. Nine hundred twenty incident cases of diabetes were matched with 5258 controls by age, sex, and bipolar index month and year. Diabetes cases were identified by either diagnosis of ICD-9 codes or diabetic medications. Patients with diabetes had a minimum 3-month exposure to any medications or at least 3 prescriptions for their bipolar or comorbidity treatment. Cox proportional hazard regression was conducted to assess the risk of diabetes associated with antipsychotic use. RESULTS: Of 920 cases, 41% received atypical antipsychotics (e.g., olanzapine, risperidone, quetiapine, ziprasidone, clozapine) and 34% received conventional antipsychotics. Compared to patients receiving conventional antipsychotics, the risk of diabetes was greatest among patients taking clozapine (hazard ratio [HR] = 7.0, 95% confidence interval [CI] = 1.7 to 28.9), risperidone (HR = 3.4, 95% CI = 2.8 to 4.2), olanzapine (HR = 3.2, 95% CI = 2.7 to 3.8), and quetiapine (HR = 1.8, 95% CI =1.4 to 2.4), with controlling covariates of age; sex; duration of follow-up; use of lithium, anticonvulsants, antidepressants, or concomitant drugs; and psychiatric and medical comorbidities. CONCLUSION: Development or exacerbation of diabetes mellitus is associated with antipsychotic use in bipolar patients. Metabolic complications are a major issue in patients receiving antipsychotic therapy. Thus, the propensity of an antipsychotic to induce diabetes should be a consideration when selecting an agent for patients with bipolar disorder.


Assuntos
Antipsicóticos/efeitos adversos , Transtorno Bipolar/tratamento farmacológico , Diabetes Mellitus/induzido quimicamente , Adolescente , Adulto , Idoso , Antipsicóticos/uso terapêutico , Transtorno Bipolar/diagnóstico , Estudos de Casos e Controles , Criança , Estudos de Coortes , Uso de Medicamentos/estatística & dados numéricos , Feminino , Humanos , Formulário de Reclamação de Seguro/estatística & dados numéricos , Classificação Internacional de Doenças , Masculino , Programas de Assistência Gerenciada/estatística & dados numéricos , Medicaid/estatística & dados numéricos , Pessoa de Meia-Idade , Farmacoepidemiologia , Estudos Retrospectivos , Fatores de Risco
13.
J Manag Care Pharm ; 12(1): 33-42, 2006.
Artigo em Inglês | MEDLINE | ID: mdl-16420106

RESUMO

OBJECTIVE: The objectives of this research were to (1) determine the association of the use of leukotriene modifiers (LMs) with 3 clinical outcome measures that can serve as proxy measures of effectiveness: subsequent emergency room visits, hospitalizations, and steroid bursts, and (2) estimate whether LM use compared with nonuse is cost beneficial from a Medicaid payer perspective. METHODS: This was a retrospective, longitudinal study of asthma patients in the fee-for-service Ohio Medicaid program. The study population included 5,541 adult patients who were identified as having a claim containing an International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9-CM) code for asthma (code 493.xx, excluding 493.2x) in 2001. Logistic regression, controlling for selection bias through the use of propensity scores, was used to determine the association of LM use on 3 outcome measures: emergency room visits, hospitalizations, and steroid bursts. An oral steroid burst was defined as a pharmacy claim for oral prednisone in the date range from 1 day before to 3 days after an office visit that has an ICD-9-CM code for asthma. A cost-benefit analysis was also performed. RESULTS: During the prestudy period, the LM users had higher total medical costs of $72.06 per patient per month (PPPM, $170.60 vs. $98.54, P <0.001). During the outcome period, there was no significant association between LM use and emergency room visits (odds ratio [OR] 1.09; 95% confidence interval [CI], 0.84-1.38), hospitalizations (OR 1.02; 95% CI, 0.66-1.59), or steroid bursts (OR 1.30; 95% CI, 0.89-1.90). Because LM use was not more effective than nonuse and is more expensive than nonuse, a situation of dominance prevails. The mean cost difference in the 3 primary outcome measures between LM users and nonusers was $1.63 PPPM ($34.93 vs. $33.30, P=0.019). CONCLUSION: In this study of adult Medicaid asthma patients, users of LMs did not have greater asthma control as measured by emergency room visits, hospitalizations, or steroid bursts. In this cohort of adult asthma patients with at least 1 asthma medication, there does not appear to be any cost offsets to the Ohio Medicaid program associated with the use of LMs. The use of LMs was associated with higher total costs for asthma care.


Assuntos
Asma/tratamento farmacológico , Leucotrienos/economia , Medicaid , Adulto , Análise Custo-Benefício , Feminino , Humanos , Leucotrienos/administração & dosagem , Leucotrienos/uso terapêutico , Estudos Longitudinais , Masculino , Pessoa de Meia-Idade , Ohio , Estudos Retrospectivos , Resultado do Tratamento
14.
Pharmacotherapy ; 25(8): 1044-54, 2005 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-16207094

RESUMO

STUDY OBJECTIVE: To assess the risk of acute pancreatitis in patients receiving various combinations of protease inhibitors, nucleoside reverse transcriptase inhibitors (NRTIs), and nonnucleoside reverse transcriptase inhibitors (NNRTIs) for treatment of human immunodeficiency virus (HIV) infection. DESIGN: Retrospective cohort study. DATA SOURCE: Ohio Medicaid claims database, January 1997-December 2002. PATIENTS: Four thousand nine hundred seventy-two patients with HIV infection who had received at least one antiretroviral drug. MEASUREMENTS AND MAIN RESULTS: Three combination regimens were evaluated: didanosine plus other antiretroviral agents, protease inhibitors plus NRTIs or NNRTIs, and NRTI combinations (no didanosine) or NRTIs plus NNRTIs. We used Cox proportional hazard regression and Kaplan-Meier plots to examine the risk for acute pancreatitis. We identified 159 (3.2%) cases of acute pancreatitis during the study period. For patients who were newly treated for HIV, the incidence of acute pancreatitis was 1.95/100 person-years. Half of these cases developed within 500 days of the start of drug therapy. Hazard ratios (HRs) for acute pancreatitis were 39-54% higher for nonwhite patients than Caucasians and 240-290% higher for symptomatic versus nonsymptomatic patients. Hazard ratios also were significantly associated with increased age, liver injuries (HR 2.94, 6.73), and cardiovascular diseases (HR 1.68, 2.36), respectively, for both newly treated and previously diagnosed patients with HIV. The risk for patients receiving either protease inhibitors plus an NRTI or an NNRTI, or NRTI plus NNRTI combinations was not significantly different from the risk associated with didanosine combination therapy (p>0.10). CONCLUSION: The risk of acute pancreatitis was significantly associated with age, race, symptomatic HIV infection, and liver and cardiovascular diseases. However, risk did not differ significantly among patients with different antiretroviral regimens. Our results can be used by the medical community to enhance patient safety and minimize costly adverse drug reactions among patients with HIV infection.


Assuntos
Fármacos Anti-HIV/efeitos adversos , Infecções por HIV/complicações , Pancreatite/induzido quimicamente , Doença Aguda , Adolescente , Adulto , Fármacos Anti-HIV/uso terapêutico , Estudos de Coortes , Comorbidade , Quimioterapia Combinada , Feminino , Inibidores da Protease de HIV/efeitos adversos , Inibidores da Protease de HIV/uso terapêutico , Humanos , Masculino , Medicaid/estatística & dados numéricos , Pessoa de Meia-Idade , Ohio/epidemiologia , Testes de Função Pancreática , Pancreatite/epidemiologia , Modelos de Riscos Proporcionais , Estudos Retrospectivos , Inibidores da Transcriptase Reversa/efeitos adversos , Inibidores da Transcriptase Reversa/uso terapêutico , Fatores de Risco
15.
J Am Pharm Assoc (Wash) ; 42(4): 587-93, 2002.
Artigo em Inglês | MEDLINE | ID: mdl-12150357

RESUMO

OBJECTIVE: To evaluate the impact of Medicaid managed care (MC) enrollment on prescription use and costs. DESIGN: Retrospective, cross-sectional analysis of claims submitted over a 6-month period. SETTING: Ohio Medicaid. PATIENTS AND OTHER PARTICIPANTS: Stratified, random selection of 2,932 MC and 1,335 fee-for-service (FFS) recipients. MAIN OUTCOME MEASURES: Dependent variables were the probability of any prescription use and 6-month prescription counts and costs. Independent variables included age, plan enrollment (MC or FFS), county enrollment status (mandatory or voluntary), presence of a chronic comorbidity, and any outpatient medical visit. RESULTS: After adjusting for comorbidities and outpatient medical visits, plan enrollment effects depended on age. FFS enrollees 8 to 12 and 12 to 18 years old were less likely (adjusted odds ratios 0.56 and 0.58, respectively) to receive a prescription, while enrollees over 30 years of age were 2.98 times more likely to receive a prescription. Among prescription users, level of use and costs were consistent across all ages for MC enrollees. FFS enrollees had 25% to 218% higher levels of prescription use than MC enrollees, depending on age. Prescription costs were 8% lower for FFS enrollees ages 4 to 8 but higher for all enrollees in other age groups (range, 22% to 311% higher). CONCLUSION: Prescription use and costs were lower for Medicaid MC enrollees than they were for patients in traditional FFS plans. Further research is needed to examine the quality of care for both FFS and MC enrollees.


Assuntos
Prescrições de Medicamentos/economia , Programas de Assistência Gerenciada/economia , Medicaid/economia , Adolescente , Adulto , Fatores Etários , Criança , Pré-Escolar , Redução de Custos , Custos de Medicamentos , Humanos , Lactente , Ohio , Estudos Retrospectivos
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