RESUMO
Colfax, Louisiana hosts a commercial hazardous waste thermal treatment (TT) facility, which treats fireworks, explosives, and military ordnances by open-burn/open-detonation one mile from the edge of the nearest community. Seventy-one percent of Colfax's residents are Black, and forty-six percent live below poverty, indicating the community's structural vulnerability. This community-based study originated at the behest of Colfax community members. We hypothesized that the close relationships among members of this enclave may have enhanced the community's ability to mobilize in opposition to the TT facility. We conducted semi-structured oral history interviews with nineteen community members and examined the social and interorganizational networks used by the Colfax community to claim its role in decision-making regarding the TT facility after years of exclusion from this process. Interview transcripts were analyzed through the lens of community capacity theory to gain insight into how interactions among community members about the environmental hazards led to social mobilization and improved participation in the decision-making process using codes for communication, organization, and outcome. Additionally, we reviewed Louisiana Department of Environmental Quality records for complaints about the facility to gauge public participation. One notable theme across several interviews was exclusion from the initial decision-making process related to the facility. However, interviewees noted a sustained effort was made among community members to educate themselves about the facility, organize a response through neighbor-to-neighbor contact, and take action by submitting formal complaints and participating in public hearings. Through the lens of environmental justice, this study illustrates an evolving condition of procedural justice.
RESUMO
A possible misconception among radiologists is that chronic subdural hemorrhage should show some degree of blooming on T2*-gradient recalled-echo or susceptibility-weighted sequences such as SWI and susceptibility-weighted angiography, which is not necessarily true. We present 5 cases of chronic subdural hemorrhages in infants, demonstrating intensity near or greater than that of CSF with variable amounts of hemosiderin staining along the neomembranes. We review the physiology and MR imaging physics behind the appearance of a chronic subdural hemorrhage, highlighting that the absence of a BBB can allow hemosiderin to be completely removed from the subdural compartment. Finally, we stress the importance of reviewing all multiplanar sequences for the presence of neomembranes, which can be quite subtle in the absence of hemosiderin staining and are critical for making the diagnosis of chronic subdural hemorrhage.
Assuntos
Maus-Tratos Infantis , Traumatismos Craniocerebrais/diagnóstico por imagem , Barreira Hematoencefálica/diagnóstico por imagem , Angiografia Cerebral , Traumatismos Craniocerebrais/líquido cefalorraquidiano , Imagem Ecoplanar , Feminino , Hematoma Subdural Crônico/líquido cefalorraquidiano , Hematoma Subdural Crônico/diagnóstico por imagem , Hemossiderina/metabolismo , Humanos , Lactente , Masculino , Estudos Retrospectivos , SobreviventesRESUMO
AIM: To test the hypothesis that computed tomographic angiography (CTA) can identify carotid body enlargement in patients with sympathetically mediated diseases. MATERIALS AND METHODS: A retrospective chart review of all patients obtaining CTAs of the cervical vasculature at University of Utah Health Sciences Center over a 6-month period was performed. Widest axial measurements of both carotid bodies were performed on a picture archiving and communication system (PACS). Statistical analysis was then performed to compare the mean carotid body size between control patients and patients with diabetes mellitus, hypertension, and congestive heart failure. RESULTS: Measurements were performed on 288 patients, with 134 controls. Of the remaining 154, 72 patients had diabetes mellitus, 46 had congestive heart failure, and 130 had hypertension. The control patients had a mean carotid body diameter of 2.3 mm. There was a statistically significant (p < 0.01) 20-25% increase in mean diameter with diabetes mellitus (2.8 mm), hypertension (2.7 mm), and congestive heart failure (2.7 mm; p < 0.01). CONCLUSIONS: This study found a 20-25% larger mean carotid body size in patients with diabetes mellitus, hypertension, and congestive heart failure relative to controls. However, this small enlargement should not mimic other carotid body diseases, such as a paraganglionoma. Moreover, these findings further support the proposed functional relationship between the carotid body and sympathetically mediated disease states.
Assuntos
Corpo Carotídeo/diagnóstico por imagem , Angiografia Cerebral/métodos , Tomografia Computadorizada por Raios X/métodos , Adulto , Corpo Carotídeo/patologia , Estudos de Casos e Controles , Comorbidade , Meios de Contraste , Feminino , Humanos , Iopamidol , Masculino , Pessoa de Meia-Idade , Estudos RetrospectivosRESUMO
OBJECTIVE: In the absence of head-to-head trials, it is not feasible to make direct comparisons of antiepileptic therapies for the treatment of Lennox-Gastaut syndrome (LGS). We conducted indirect comparisons of the relative efficacies of clobazam, felbamate, lamotrigine, topiramate, and rufinamide as adjunctive treatments for LGS. METHODS: Clinical studies of LGS patients were identified in a 2009 Cochrane review and by electronic database search. Five randomized controlled trials were included in this systematic review, which reports findings from indirect comparisons between clobazam and other approved adjunctive LGS therapies (felbamate, lamotrigine, topiramate, rufinamide) in the United States and Europe. As outcomes were not uniformly reported across studies, the primary efficacy endpoint from each trial was transformed into Cohen's d effect size, to facilitate indirect comparisons. Typical interpretations of Cohen's d results are as follows: d < 0.2, change not detectable; 0.2 ≤ d < 0.5, small change; 0.5 ≤ d < 0.8, moderate change; and 0.8 ≤ d, large change. RESULTS: High-dosage clobazam (1.0 mg/kg/day) was found to have the strongest treatment effect vs placebo (effect size 0.80), with moderate effects (effect sizes >0.50) for medium-dosage clobazam (0.5 mg/kg/day) and rufinamide. Felbamate, lamotrigine, and topiramate had low effect sizes. Indirect comparisons of numbers of total seizures and tonic-atonic seizures ('drop attacks') demonstrated superiority of both clobazam dosages over all comparators. CONCLUSIONS: High- and medium-dosage clobazam was estimated to be more efficacious than other LGS treatments. Our analysis relied on published data and could not draw on direct head-to-head data of clobazam with alternatives. Further comparative research is ongoing to assess the usefulness of clobazam for LGS.
Assuntos
Anticonvulsivantes/uso terapêutico , Benzodiazepinas/uso terapêutico , Deficiência Intelectual/terapia , Espasmos Infantis/terapia , Clobazam , Bases de Dados Factuais/estatística & dados numéricos , Relação Dose-Resposta a Droga , Europa (Continente) , Humanos , Síndrome de Lennox-Gastaut , Resultado do Tratamento , Estados UnidosRESUMO
OBJECTIVES: Compare adverse events (AEs) in patients with epilepsy taking different antiepileptic drugs (AEDs) using standardized physician-completed questionnaires. MATERIALS AND METHODS: Multicenter, observational, cross-sectional study in epilepsy patients aged ≥4 , stable on 1-2 AED(s) for ≥3 months. RESULTS: One thousand and nineteen patients were evaluated: 28.7% took newer, 71.3% older (or older + newer) AED(s); 56.9% monotherapy; 43.1% polytherapy. Overall, 68.3% reported ≥1 AE (61.3% newer; 71.1% older AEDs), most commonly: cognitive function disturbances, sedation, psychological problems. Patients taking newer AEDs were significantly less likely to report ≥1 AE (OR [95% CI]: 0.64 [0.46-0.89], P = 0.008). Treatment/dose changed at study visit: 22.8% (17.5% newer; 24.9% older AEDs) because of (newer/older); lack of efficacy (6.2%/7.8%); AEs (4.1/8.4%); absence of seizures (3.8/4.0%). Patients receiving levetiracetam or lamotrigine were significantly less likely to report AEs/modify treatment. CONCLUSION: Patients taking newer AEDs were significantly less likely to report AEs, although the non-randomized study design does not allow the lower rate of AEs to be attributed with certainty to the use of newer AEDs. A standardized AE questionnaire appeared useful for monitoring AEs/optimizing AED therapy.
Assuntos
Anticonvulsivantes/efeitos adversos , Epilepsia/tratamento farmacológico , Adulto , Anticonvulsivantes/uso terapêutico , Estudos Transversais , Quimioterapia Combinada , Europa (Continente) , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Inquéritos e QuestionáriosRESUMO
Most pregnant women with epilepsy require antiepileptic drug (AED) therapy. Present guidelines recommend optimizing treatment prior to conception, choosing the most effective AED for seizure type and syndrome, using monotherapy and lowest effective dose, and supplementing with folate. The Epilepsy Therapy Project established the international Health Outcomes in Pregnancy and Epilepsy (HOPE) forum to learn more about the impact of AEDs on the developing fetus, particularly the role of pregnancy registries in studying AED teratogenicity. The primary outcome of interest in these registries is the occurrence of major congenital malformations, with some data collected on minor malformations. Cognitive and behavioral outcomes are often beyond the timeframe for follow-up of these registries and require independent study. The HOPE consensus report describes the current state of knowledge and the limitations to interpretations of information from the various sources. Data regarding specific risks for both older and newer AEDs need to be analyzed carefully, considering study designs and confounding factors. There is a critical need for investigations to delineate the underlying mechanisms and explain the variance seen in outcomes across AEDs and within a single AED.
Assuntos
Anormalidades Induzidas por Medicamentos/epidemiologia , Anticonvulsivantes/efeitos adversos , Epilepsia/tratamento farmacológico , Avaliação de Resultados em Cuidados de Saúde/estatística & dados numéricos , Complicações na Gravidez/tratamento farmacológico , Sistema de Registros/estatística & dados numéricos , Austrália/epidemiologia , Pré-Escolar , Transtornos Cognitivos/induzido quimicamente , Transtornos Cognitivos/epidemiologia , Deficiências do Desenvolvimento/induzido quimicamente , Deficiências do Desenvolvimento/epidemiologia , Europa (Continente)/epidemiologia , Feminino , Humanos , Deficiência Intelectual/induzido quimicamente , Deficiência Intelectual/epidemiologia , Estudos Multicêntricos como Assunto/estatística & dados numéricos , Gravidez , Vigilância de Produtos Comercializados/estatística & dados numéricos , Reino Unido/epidemiologia , Estados Unidos/epidemiologiaRESUMO
BACKGROUND: Newer antiepileptic drugs (AEDs) have been shown to be equally efficacious as older seizure medications but with fewer neurotoxic and systemic side effects in the elderly. A growing body of clinical recommendations based on systematic literature review and expert opinion advocate the use of the newer agents and avoidance of phenobarbital and phenytoin. This study sought to determine if changes in practice occurred between 2000 and 2004--a time during which evidence and recommendations became increasingly available. METHODS: National data from the Veterans Health Administration (VA; inpatient, outpatient, pharmacy) from 1998 to 2004 and Medicare data (1999-2004) were used to identify patients 66 years and older with new-onset epilepsy. Initial AED was the first AED received from the VA. AEDs were categorized into four groups: phenobarbital, phenytoin, standard (carbamazepine, valproate), and new (gabapentin, lamotrigine, levetiracetam, oxcarbazepine, topiramate). RESULTS: We found a small reduction in use of phenytoin (70.6% to 66.1%) and phenobarbital (3.2% to 1.9%). Use of new AEDs increased significantly from 12.9% to 19.8%, due primarily to use of lamotrigine, levetiracetam, and topiramate. CONCLUSIONS: Despite a growing list of clinical recommendations and guidelines, phenytoin was the most commonly used antiepileptic drug, and there was little change in its use for elderly patients over 5 years. Research further exploring physician and health care system factors associated with change (or lack thereof) will provide better insight into the impact of clinical recommendations on practice.
Assuntos
Anticonvulsivantes/uso terapêutico , Epilepsia/tratamento farmacológico , Epilepsia/epidemiologia , Geriatria , Idoso , Idoso de 80 Anos ou mais , Algoritmos , Distribuição de Qui-Quadrado , Estudos de Coortes , Prescrições de Medicamentos/estatística & dados numéricos , Humanos , Padrões de Prática Médica/tendências , Reprodutibilidade dos Testes , Estudos Retrospectivos , VeteranosRESUMO
OBJECTIVES: To review studies of patient compliance/persistence with cardiovascular or antidiabetic medication published since the year 2000; to compare the methods used to measure compliance/persistence across studies; to compare reported compliance/persistence rates across therapeutic classes and to assess whether compliance/persistence correlates with clinical outcomes. METHODS: English language papers published between January 2000 and November 2005 investigating patient compliance/persistence with cardiovascular or antidiabetic medication were identified through searches of the MEDLINE and EMBASE databases. Definitions and measurements of compliance/persistence were compared across therapeutic areas using contingency tables. RESULTS: Of the 139 studies analysed, 32% focused on hypertension, 27% on diabetes and 13% on dyslipidaemia. The remainder covered coronary heart disease and cardiovascular disease (CVD) in general. The most frequently reported measure of compliance was the 12-month medication possession ratio (MPR). The overall mean MPR was 72%, and the MPR did not differ significantly between treatment classes (range: 67-76%). The average proportion of patients with an MPR of >80% was 59% overall, 64% for antihypertensives, 58% for oral antidiabetics, 51% for lipid-lowering agents and 69% in studies of multiple treatments, again with no significant difference between treatment classes. The average 12-month persistence rate was 63% and was similar across therapeutic classes. Good compliance had a positive effect on outcome in 73% of the studies examining clinical outcomes. CONCLUSIONS: Non-compliance with cardiovascular and antidiabetic medication is a significant problem, with around 30% of days 'on therapy' not covered by medication and only 59% of patients taking medication for more than 80% of their days 'on therapy' in a year. Good compliance has a positive effect on clinical outcome, suggesting that the management of CVD may be improved by improving patient compliance.
Assuntos
Diabetes Mellitus/tratamento farmacológico , Dislipidemias/tratamento farmacológico , Hipertensão/tratamento farmacológico , Cooperação do Paciente , Anti-Hipertensivos/administração & dosagem , Humanos , Hipoglicemiantes/administração & dosagem , Hipolipemiantes/administração & dosagem , Resultado do TratamentoRESUMO
BACKGROUND: Providers are increasingly being held accountable for the quality of care provided. While quality indicators have been used to benchmark the quality of care for a number of other disease states, no such measures are available for evaluating the quality of care provided to adults with epilepsy. In order to assess and improve quality of care, it is critical to develop valid quality indicators. Our objective is to describe the development of quality indicators for evaluating care of adults with epilepsy. As most care is provided in primary and general neurology care, we focused our assessment of quality on care within primary care and general neurology clinics. METHODS: We reviewed existing national clinical guidelines and systematic reviews of the literature to develop an initial list of quality indicators; supplemented the list with indicators derived from patient focus groups; and convened a 10-member expert panel to rate the appropriateness, reliability, and necessity of each quality indicator. RESULTS: From the original 37 evidence-based and 10 patient-based quality indicators, the panel identified 24 evidence-based and 5 patient-based indicators as appropriate indicators of quality. Of these, the panel identified 9 that were not necessary for high quality care. CONCLUSION: There is, at best, a poor understanding of the quality of care provided for adults with epilepsy. These indicators, developed based on published evidence, expert opinion, and patient perceptions, provide a basis to assess and improve the quality of care for this population.
Assuntos
Atenção à Saúde/métodos , Atenção à Saúde/normas , Epilepsia/diagnóstico , Epilepsia/terapia , Garantia da Qualidade dos Cuidados de Saúde/métodos , Garantia da Qualidade dos Cuidados de Saúde/normas , Terminologia como Assunto , Humanos , InternacionalidadeRESUMO
UNLABELLED: Fourteen reports utilizing data from de-identified administrative databases were reviewed. Studies contained at least one measure of patient persistence or compliance with bisphosphonates or bisphosphonates and other anti-osteoporosis medications. These studies confirm that women with osteoporosis have suboptimal persistence and compliance rates with bisphosphonate therapy. INTRODUCTION: This review summarizes patient persistence and compliance with bisphosphonates for the treatment of osteoporosis. METHODS: We conducted a MEDLINE search for the period from January 1998 to May 2006, using a detailed list of terms related to persistence and compliance with anti-osteoporosis medications. Studies were included if they contained at least one measure of persistence or compliance derived from de-identified administrative databases containing patient demographics and prescription information. RESULTS: We reviewed 14 reports, which described 14 databases. The percentage of patients persisting with therapy for 1 year ranged from 17.9% to 78.0%. Compliance, assessed as mean medication possession ratio (MPR), ranged from 0.59 to 0.81. When comparing compliance with weekly and daily bisphosphonates, the mean MPR was consistently higher for weekly versus daily therapy (0.58 to 0.76 versus 0.46 to 0.64 for patients receiving weekly and daily bisphosphonate therapy respectively). Persistence was also improved in patients receiving weekly bisphosphonates, assessed by both length of persistence (194 to 269 days [weekly] and 134 to 208 days [daily]) and percentage of persistent patients at the end of the follow-up period (35.7% to 69.7% [weekly] and 26.1% to 55.7% [daily]). CONCLUSION: Although patients using weekly bisphosphonate medication follow their prescribed dosing regimens better than those using daily therapy, overall compliance and persistence rates were suboptimal.
Assuntos
Conservadores da Densidade Óssea/administração & dosagem , Difosfonatos/administração & dosagem , Osteoporose/tratamento farmacológico , Adulto , Esquema de Medicação , Feminino , Terapia de Reposição Hormonal , Humanos , Pessoa de Meia-Idade , Osteoporose/psicologia , Osteoporose Pós-Menopausa/tratamento farmacológico , Osteoporose Pós-Menopausa/psicologia , Cooperação do Paciente/psicologiaRESUMO
About 50% of patients fail to comply or persist with anti-osteoporosis treatment regimens within 1 year. Poor compliance is associated with higher fracture rates. Causes of poor compliance are unknown. As it is not possible to predict poor compliance, close monitoring of compliance is needed. Despite evidence supporting the anti-fracture efficacy of several pharmacological agents, approximately 50% of patients do not follow their prescribed treatment regimen and/or discontinue treatment within 1 year. Poor compliance is associated with higher fracture rates and increased morbidity, mortality and cost. However, as poor compliance, even to placebo, is associated with adverse outcomes, the higher morbidity appears to be only partly the result of lack of treatment: as yet, undefined characteristics place poor compliers at higher risk of morbidity and mortality. Only a small proportion (e.g., 6%) of the variability in compliance is explained by putative causal factors such as older age, co-morbidity or greater number of medications. Regimens with longer dosing intervals, such as weekly dosing, improve compliance, persistence and outcomes, but only modestly. As it is not possible to predict poor compliance, close monitoring of compliance should be an obligatory duty in clinical care. How this is best achieved has yet to be established, but poor persistence occurs as early as 3 months of starting treatment, indicating the need for early monitoring.
Assuntos
Conservadores da Densidade Óssea/uso terapêutico , Fraturas Ósseas/prevenção & controle , Osteoporose/tratamento farmacológico , Cooperação do Paciente , Feminino , Fraturas Ósseas/etiologia , Humanos , Osteoporose/complicações , Fatores de RiscoRESUMO
OBJECTIVES: To develop a measure of treatment satisfaction assessing attributes specific to injected interferon-beta-1a (IFN-beta-1a) for multiple sclerosis (MS), and to test pain and instrument sensitivity to change among patients changing injection devices. MATERIALS AND METHODS: The MS Treatment Concerns Questionnaire (MSTCQ) was developed and tested with pain assessments before and 3 months after patients changed devices from Rebiject to Rebiject II. RESULTS: The MSTCQ was organized with two domains: Injection System Satisfaction and Side Effects (three subscales: Injection Site Reactions, Global Satisfaction, and Flu-Like Symptoms). Significant improvements (P = 0.002 to P < 0.001) occurred with the new injection device in all MSTCQ subscales (except Flu-Like Symptoms), and all pain measures (P < 0.0001). Clinically meaningful improvement was demonstrated in all scales, except Flu-Like Symptoms, by effect sizes (0.23-0.59). CONCLUSIONS: These statistically significant and clinically meaningful improvements in MSTCQ and pain measures show the value of technologically advanced devices in domains of concern to patients.
Assuntos
Adjuvantes Imunológicos/administração & dosagem , Adjuvantes Imunológicos/uso terapêutico , Interferon beta/administração & dosagem , Interferon beta/uso terapêutico , Esclerose Múltipla/tratamento farmacológico , Dor/etiologia , Satisfação do Paciente , Adulto , Feminino , Humanos , Injeções Subcutâneas , Interferon beta-1a , Masculino , Pessoa de Meia-Idade , Psicometria , Resultado do TratamentoRESUMO
OBJECTIVE: The AERx Insulin Diabetes Management System [AERx iDMS, jointly developed by Novo Nordisk (Bagsvaerd, Denmark) and Aradigm Corp. (Hayward, CA)] provides insulin by pulmonary administration. This investigation was designed as a pilot trial to demonstrate the ability of patients to use the electronic device to deliver mealtime inhaled insulin doses and explore the impact on compliance. METHODS: AERx iDMS was evaluated in a substudy of a 12-week, multicenter open trial by adult patients with type 2 diabetes previously on any insulin regimen. The device was used for dosing fast-acting human insulin immediately before main meals, in combination with bedtime NPH insulin. The AERx iDMS device recorded the date and time of each insulin inhalation, insulin units used, and inhalation technique during aerosol delivery. Compliance was defined as the percentage of prescribed doses taken during the treatment period, dose timing, and the efficiency of dosing technique. RESULTS: Insulin dosing for 49 patients (age 59.1 +/- 7.7 years) using AERx iDMS was monitored for 78.9 +/- 10 days (range, 41-94 days) with 226 +/- 35 doses (range, 122-272 doses). Patients inhaled on average 2.9 +/- 0.3 doses of insulin daily, taking an average of 11.8 +/- 5.6 units per dose. Compliance with the prescribed regimen was 94.3 +/- 9.1% (range, 45-100%). Overall, 4.2 +/- 9.5% of prescribed doses were omitted. Hemoglobin A1c decreased 0.77 +/- 0.96% from baseline to the end of the study. Inhalation technique was excellent, with 97% of patients experiencing fewer than five inadequate doses. CONCLUSIONS: Excellent compliance with AERx iDMS dosing, timing, and inhalation technique showed that the device was well accepted by patients. The electronic monitoring feature could be used as an educational tool to help patients and clinicians manage insulin dosing.
Assuntos
Diabetes Mellitus Tipo 2/tratamento farmacológico , Diabetes Mellitus Tipo 2/psicologia , Insulina/administração & dosagem , Insulina/uso terapêutico , Cooperação do Paciente , Administração por Inalação , Adulto , Aerossóis , Humanos , Hipoglicemiantes/administração & dosagem , Hipoglicemiantes/uso terapêutico , Pessoa de Meia-Idade , Projetos PilotoRESUMO
BACKGROUND: Although naltrexone, an opiate-receptor antagonist, has been approved by the Food and Drug Administration for the treatment of alcohol dependence, its efficacy is uncertain. METHODS: We conducted a multicenter, double-blind, placebo-controlled evaluation of naltrexone as an adjunct to standardized psychosocial treatment. We randomly assigned 627 veterans (almost all men) with chronic, severe alcohol dependence to 12 months of naltrexone (50 mg once daily), 3 months of naltrexone followed by 9 months of placebo, or 12 months of placebo. All patients were offered individual counseling and programs to improve their compliance with study medication and were encouraged to attend Alcoholics Anonymous meetings. RESULTS: There were 209 patients in each group; all had been sober for at least five days before randomization. At 13 weeks, we found no significant difference in the number of days to relapse between patients in the two naltrexone groups (mean, 72.3 days) and the placebo group (mean, 62.4 days; 95 percent confidence interval for the difference between groups, -3.0 to 22.8). At 52 weeks, there were no significant differences among the three groups in the percentage of days on which drinking occurred and the number of drinks per drinking day. CONCLUSIONS: Our findings do not support the use of naltrexone for the treatment of men with chronic, severe alcohol dependence.
Assuntos
Alcoolismo/tratamento farmacológico , Naltrexona/uso terapêutico , Antagonistas de Entorpecentes/uso terapêutico , Alcoólicos Anônimos , Alcoolismo/terapia , Terapia Combinada , Aconselhamento , Método Duplo-Cego , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Análise Multivariada , Cooperação do Paciente , Recidiva , Falha de TratamentoRESUMO
OBJECTIVE: To determine the feasibility of using the Medication Event Monitoring System (MEMS) to estimate medication compliance in patients with schizophrenia or schizoaffective disorder. SUBJECTS AND SETTING: Fourteen of 35 consecutive patients admitted to a psychiatric inpatient hospital with schizophrenia or schizoaffective disorder who met eligibility requirements and gave informed consent. INTERVENTION: After random assignment to either risperidone or typical antipsychotic treatment, medication upon discharge from hospital was dispensed in a bottle with a MEMS cap which recorded the number of bottle openings and the date and time of each opening. The first 6 patients were asked to return monthly for data downloading. The next 8 were asked to return weekly during the first month and every 2 weeks thereafter; they were also paid $5 for returning each bottle. OUTCOME MEASURES: MEMS data collected over a 6-month period and hospital readmission data. RESULTS: Patient medication compliance data were collected from 10 (71%) of 14 patients during the first month, from 7 (58%) of 12 (2 patients dropped out) during the second and from 5 (45%) of 11 (a third patient dropped out) during months 3-6. Mean compliance rates were 63% for the first month and ranged from 56% to 45% over the next 5. First-month compliance rates were significantly lower for those who were subsequently readmitted to hospital (n = 7) than for those who were not (p < 0.01). CONCLUSIONS: Electronic monitoring devices can be used to estimate compliance with medication regimens in patients with severe schizophrenic disorders, but there are methodological improvements that can be made to increase data recovery and compliance, and these are discussed.
Assuntos
Antipsicóticos/administração & dosagem , Monitoramento de Medicamentos/instrumentação , Embalagem de Medicamentos , Cooperação do Paciente , Transtornos Psicóticos/tratamento farmacológico , Risperidona/administração & dosagem , Esquizofrenia/tratamento farmacológico , Adulto , Antipsicóticos/efeitos adversos , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Cooperação do Paciente/psicologia , Readmissão do Paciente , Transtornos Psicóticos/diagnóstico , Transtornos Psicóticos/psicologia , Risperidona/efeitos adversos , Esquizofrenia/diagnóstico , Autoadministração , Recusa do Paciente ao Tratamento/psicologiaRESUMO
PURPOSE: the choices available for patients whose partial seizures are poorly controlled include seven new antiepileptic drugs (AEDs) or vagal nerve stimulation (VNS) as add-on therapy. Comparisons are needed to help physicians and patients select among the options for treatment. METHODS: we compared efficacy and adverse events of new treatments from controlled clinical trials of patients with uncontrolled partial seizures. Response rates (> or =50% decrease in partial seizures) at doses recommended in product labeling for adjunct therapy were tabulated for overall success (placebo response rate subtracted from AED response rate). Adverse events listed in product labeling were tabulated as complaint rates (placebo events subtracted from AED events). VNS trials used low dose stimulation as a pseudo-placebo. RESULTS: overall success rates fell into two general groups with ranges of 12-20% for gabapentin (GBP), lamotrigine (LTG), tiagabine (TGB), zonisamide and 27-29% for levetiracetam, oxcarbazepine, and topiramate (TPM). Summary Complaint Scores also fell into two general groups with ranges of -27 to -82 for GBP, levetiracetam, TGB, zonisamide and -113 to -205 for LTG, oxcarbazepine and TPM. VNS scores were in the lower or higher success and summary complaint categories depending on whether scores from the pseudo-placebo group were subtracted from the high dose group. CONCLUSIONS: these data allow comparisons among AEDs and VNS using similar data from standard types of clinical trials.
Assuntos
Anticonvulsivantes/uso terapêutico , Terapia por Estimulação Elétrica , Epilepsia/terapia , Nervo Vago , Anticonvulsivantes/efeitos adversos , Ensaios Clínicos como Assunto/estatística & dados numéricos , Terapia por Estimulação Elétrica/métodos , Epilepsia Parcial Sensorial/terapia , HumanosRESUMO
PURPOSE: This report provides detailed review of safety information on levetiracetam (LEV) (Keppra), a new antiepileptic drug. METHODS: The integrated summary of safety report submitted for regulatory review was examined to collate information about abnormal laboratory tests values and adverse event reports collected during the overall LEV development program. Analyses included 3347 patients exposed to LEV in clinical trials for epilepsy, cognition, and anxiety disorders. RESULTS: Safety data from all studies depict a similar pattern of adverse effects, predominantly somnolence, asthenia, and dizziness that occurred most frequently during the first month of LEV treatment. Changes in laboratory test values from placebo-controlled trials that were statistically significant remained in the normal range (red blood cells, hematocrit, hemoglobin, white blood cells, and neutrophils). Reports of the coding term 'infection' (common cold, upper respiratory infection) were not preceded by low neutrophil counts that might suggest impaired immunological status. Selection of adverse event coding terms probably contributed to the high rate of adverse effects termed 'infection.' Higher incidences of adverse effects, particularly behavioral effects, were found among epilepsy patients than in elderly patients with cognitive disorders or patients with anxiety disorders given lower doses. CONCLUSIONS: This review of patients evaluated during the clinical development program suggests that LEV was well tolerated and safe for patients with seizure, cognitive and anxiety disorders. Overall incidence of adverse effects in the LEV groups was little higher than reports from the placebo groups. Of course, this data was derived from clinical trials that are of relatively short duration, and provide data on only several thousand patients. Therefore, long-term side effects, and/or rare side effects cannot be ruled out on the basis of this analysis.
Assuntos
Anticonvulsivantes/efeitos adversos , Epilepsia/tratamento farmacológico , Piracetam/análogos & derivados , Piracetam/efeitos adversos , Ensaios Clínicos como Assunto/estatística & dados numéricos , Epilepsia/epidemiologia , LevetiracetamRESUMO
OBJECTIVE: To develop and validate a brief survey of migraine-related quality-of-life issues. The Headache Needs Assessment (HANA) questionnaire was designed to assess two dimensions of the chronic impact of migraine (frequency and bothersomeness). METHODS: Seven issues related to living with migraine were posed as ratings of frequency and bothersomeness. Validation studies were performed in a Web-based survey, a clinical trial responsiveness population, and a retest reliability population. Headache characteristics (eg, frequency, severity, and treatment), demographic information, and the Headache Disability Inventory were used for external validation. RESULTS: The HANA was completed in full by 994 adults in the Web survey, with a mean total score of 77.98 +/- 40.49 (range, 7 to 175). There were no floor or ceiling effects. The HANA met the standards for validity with internal consistency reliability (Cronbach alpha =.92, eigenvalue for the single factor = 4.8, and test-retest reliability = 0.77). External validity showed a high correlation between HANA and Headache Disability Inventory total scores (0.73, P<.0001), and high correlations with disease and treatment characteristics. CONCLUSIONS: These data demonstrate the psychometric properties of the HANA. The brief questionnaire may be a useful screening tool to evaluate the impact of migraine on individuals. The two-dimensional approach to patient-reported quality of life allows individuals to weight the impact of both frequency and bothersomeness of chronic migraines on multiple aspects of daily life.
Assuntos
Transtornos de Enxaqueca , Qualidade de Vida , Inquéritos e Questionários , Atividades Cotidianas , Adolescente , Adulto , Idoso , Feminino , Nível de Saúde , Humanos , Internet , Masculino , Pessoa de Meia-Idade , Transtornos de Enxaqueca/classificação , Transtornos de Enxaqueca/complicações , Transtornos de Enxaqueca/psicologia , Avaliação das Necessidades , Psicometria , Reprodutibilidade dos Testes , Inquéritos e Questionários/normas , Estados UnidosRESUMO
A review of the literature on methods of seizure or epilepsy severity assessments resulted in tabulation of the seizure rating scales known as US Department of Veterans Affairs (VA), Chalfont-National Hospital, Liverpool, Hague, and others. Each of the scales reviewed has some advantages, but none of them appears to be adequate to assess seizure or epilepsy severity. Most of the scales use similar components of seizures to evaluate severity. However, the disadvantages of each scale outweigh its usefulness. New approaches are needed to assess seizure severity for individuals and for use as an outcome measure after intervention such as surgery or medication changes.