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1.
PLoS Med ; 16(5): e1002800, 2019 05.
Artigo em Inglês | MEDLINE | ID: mdl-31067237

RESUMO

BACKGROUND: Treatment decision-making regarding immunosuppressive therapy is challenging for individuals with lupus. We assessed the effectiveness of a decision aid for immunosuppressive therapy in lupus nephritis. METHODS AND FINDINGS: In a United States multicenter, open-label, randomized controlled trial (RCT), adult women with lupus nephritis, mostly from racial/ethnic minority backgrounds with low socioeconomic status (SES), seen in in- or outpatient settings, were randomized to an individualized, culturally tailored, computerized decision aid versus American College of Rheumatology (ACR) lupus pamphlet (1:1 ratio), using computer-generated randomization. We hypothesized that the co-primary outcomes of decisional conflict and informed choice regarding immunosuppressive medications would improve more in the decision aid group. Of 301 randomized women, 298 were analyzed; 47% were African-American, 26% Hispanic, and 15% white. Mean age (standard deviation [SD]) was 37 (12) years, 57% had annual income of <$40,000, and 36% had a high school education or less. Compared with the provision of the ACR lupus pamphlet (n = 147), participants randomized to the decision aid (n = 151) had (1) a clinically meaningful and statistically significant reduction in decisional conflict, 21.8 (standard error [SE], 2.5) versus 12.7 (SE, 2.0; p = 0.005) and (2) no difference in informed choice in the main analysis, 41% versus 31% (p = 0.08), but clinically meaningful and statistically significant difference in sensitivity analysis (net values for immunosuppressives positive [in favor] versus negative [against]), 50% versus 35% (p = 0.006). Unresolved decisional conflict was lower in the decision aid versus pamphlet groups, 22% versus 44% (p < 0.001). Significantly more patients in the decision aid versus pamphlet group rated information to be excellent for understanding lupus nephritis (49% versus 33%), risk factors (43% versus 27%), medication options (50% versus 33%; p ≤ 0.003 for all); and the ease of use of materials was higher in the decision aid versus pamphlet groups (51% versus 38%; p = 0.006). Key study limitations were the exclusion of men, short follow-up, and the lack of clinical outcomes, including medication adherence. CONCLUSIONS: An individualized decision aid was more effective than usual care in reducing decisional conflict for choice of immunosuppressive medications in women with lupus nephritis. TRIAL REGISTRATION: Clinicaltrials.gov, NCT02319525.


Assuntos
Técnicas de Apoio para a Decisão , Imunossupressores/uso terapêutico , Nefrite Lúpica/tratamento farmacológico , Educação de Pacientes como Assunto , Participação do Paciente , Adulto , Comportamento de Escolha , Feminino , Conhecimentos, Atitudes e Prática em Saúde , Alfabetização em Saúde , Humanos , Imunossupressores/efeitos adversos , Nefrite Lúpica/etnologia , Nefrite Lúpica/imunologia , Pessoa de Meia-Idade , Folhetos , Resultado do Tratamento , Estados Unidos/epidemiologia
2.
NPJ Prim Care Respir Med ; 24: 14018, 2014 Jun 26.
Artigo em Inglês | MEDLINE | ID: mdl-24965967

RESUMO

BACKGROUND: A housing-based socioeconomic index (HOUSES) was previously developed to overcome an absence of socioeconomic status (SES) measures in common databases. HOUSES is associated with child health outcomes in Olmsted County, Minnesota, USA, but generalisability to other geographic areas is unclear. AIM: To assess whether HOUSES is associated with asthma outcomes outside Olmsted County, Minnesota, USA. METHODS: Using a random sample of children with asthma from Sanford Children's Hospital, Sioux Falls, SD, USA, asthma status was determined. The primary outcome was asthma control status using Asthma Control Test and a secondary outcome was risk of persistent asthma. Home address information and property data were merged to formulate HOUSES. Other SES measures were examined: income, parental education (PE), Hollingshead and Nakao-Treas index. RESULTS: Of a random sample of 200 children, 80 (40%) participated in the study. Of those, 13% had poorly controlled asthma. Addresses of 94% were matched with property data. HOUSES had moderate-good correlation with other SES measures except PE. Poor asthma control rates were 31.6%, 4.8% and 5.6% for patients in the lowest, intermediate and highest tertiles of HOUSES, respectively (P=0.023). HOUSES as a continuous variable was inversely associated with poorly controlled asthma (adjusted odds ratio (OR)=0.21 per 1 unit increase of HOUSES, 95% confidence interval (CI), 0.05-0.89, P=0.035). HOUSES as a continuous variable was inversely related to risk of persistent asthma (OR: 0.36 per 1 unit increase of HOUSES, 95% CI, 0.12-1.04, P=0.06). CONCLUSIONS: HOUSES appears to be generalisable and available as a measure of SES in asthma research in the absence of conventional SES measures.


Assuntos
Asma/epidemiologia , Habitação/estatística & dados numéricos , Adolescente , Asma/terapia , Criança , Pré-Escolar , Escolaridade , Feminino , Humanos , Renda/estatística & dados numéricos , Masculino , Fatores de Risco , Índice de Gravidade de Doença , Fatores Socioeconômicos , South Dakota/epidemiologia , Resultado do Tratamento
3.
Ann Surg ; 254(4): 558-68, 2011 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-21946217

RESUMO

OBJECTIVE(S): We compared distress parameters and career satisfaction from survey results of surgeons from 14 specialties practicing in an academic versus private practice environment. METHODS: The 2008 American College of Surgeons survey evaluated demographic variables, practice characteristics, career satisfaction, and distress parameters using validated instruments. RESULTS: The practice setting (academic vs. private practice) was independently associated with burnout in a multivariate (MV) analysis (odds ratio [OR] 1.172, P = 0.02). Academic surgeons were less likely to experience burnout compared to those in private practice (37.7% vs. 43.1%), less likely to screen positive for depression (27.6% vs. 33%) or to have suicide ideation (4.7% vs. 7.4%; all P < 0.0001). They were also more likely to have career satisfaction (77.4% of academic surgeons would become a surgeon again vs. 64.9% for those in private practice; P < 0.0001)) and to recommend a medical career to their children (61.3% vs. 43.7%, P < 0.0001). For academic surgeons, the most significant positive associations with burnout were: (1) trauma surgery (OR 1.513, P = 0.0059), (2) nights on call (OR 1.062, P = 0.0123), and (3) hours worked (OR 1.019, P < 0.0001), whereas the negative associations were: (1) having older children (>22 years; OR 0.529, P < 0.0001), (2) pediatric surgery (OR 0.583, P = 0.0053), (3) cardiothoracic surgery (OR 0.626, P = 0.0117), and (4) being male (OR 0.787, P = 0.0491). In a private practice setting, the most significant positive associations with burnout were: (1) urologic surgery (OR 1.497, P = 0.0086), (2) having 31% to 50% time for nonclinical activities (OR 1.404, P = 0.0409), (3) incentive based pay (OR 1.344, P < 0.0001), (4) nights on call (OR 1.045, P = 0.0029), and (5) hours worked (OR 1.015, P < 0.0001), whereas the negative associations were: (1) older children (OR 0.677, P = 0.0001), (2) physician spouse (OR 0.753, P = 0.0093), and (3) older age (OR 0.989, P = 0.0158). The independent factors relating to career satisfaction for surgeons in private practice and academic practice were also different. CONCLUSIONS: Factors associated with burnout were distinct for academic and private practice surgeons. Distress parameters were lower and career satisfaction higher for academic surgeons.


Assuntos
Esgotamento Profissional/epidemiologia , Satisfação no Emprego , Especialidades Cirúrgicas , Centros Médicos Acadêmicos , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Setor Privado
4.
J Pain Symptom Manage ; 42(2): 213-21, 2011 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-21398089

RESUMO

CONTEXT: Aggregates of concurrent symptoms, known as symptom clusters (SxCls), are reported to have prognostic capabilities beyond that of single symptom alone. A SxCl of fatigue, dyspnea, and cough has been delineated in a number of lung cancer cohorts. OBJECTIVES: The objective of this study was to characterize this SxCl's predictive value for important clinical outcomes relative to that of its component symptoms. METHODS: Analysis of an eight-year prospective cohort study that assessed 2405 patients with LC for self-reported symptom burden, employment status, and physical activity with the Baecke questionnaire, and overall quality of life (QoL) was undertaken using nested Cox and generalized linear multilevel mixed models. Models were adjusted for longitudinally assessed demographics, cancer progression and tobacco use, and cancer progression. RESULTS: The SxCl, as well as its individual symptoms and symptom pairs, were all negatively associated with survival in Cox models of Years 1-3 after diagnosis. Only in Year 3 did the SxCl prognosticate survival (and then marginally) better than single symptoms or symptom pairs; fatigue was strongly associated (P≤0.0005) with survival at all time points. The SxCl was not predictive of participants' employment status, physical activity, or QoL, whereas the presence of fatigue, dyspnea, or their combination was strongly associated with these outcomes. CONCLUSION: Fatigue and dyspnea are strongly associated with poor clinical outcomes in LC survivors; however, a SxCl that includes fatigue, dyspnea, and cough as part as its components does not appear to significantly improve their predictive capability.


Assuntos
Carcinoma/diagnóstico , Tosse/complicações , Dispneia/complicações , Fadiga/complicações , Neoplasias Pulmonares/diagnóstico , Adulto , Idoso , Carcinoma/complicações , Tosse/diagnóstico , Autoavaliação Diagnóstica , Dispneia/diagnóstico , Fadiga/diagnóstico , Feminino , Humanos , Neoplasias Pulmonares/complicações , Masculino , Pessoa de Meia-Idade , Valor Preditivo dos Testes , Prognóstico , Estudos Prospectivos , Qualidade de Vida , Inquéritos e Questionários
5.
J Pain Symptom Manage ; 42(2): 202-12, 2011 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-21398090

RESUMO

CONTEXT: Aggregates of concurrent symptoms, known as symptom clusters (SxCls), have been described in predominantly cross-sectional samples of lung cancer (LC) patients undergoing treatment. OBJECTIVES: The objective of this study was to delineate SxCls in LC survivors up to five years after diagnosis, investigate their stability over time, and identify determinants of SxCl development and resolution. METHODS: A sensitivity approach involving multiple exploratory and confirmatory analyses was applied to an eight-year prospective cohort study that annually assessed 2405 patients with LC for symptom burden with the Lung Cancer Symptom Scale and Linear Analogue Self-Assessment. RESULTS: A single robust SxCl of fatigue, cough, and dyspnea was identified in 14.6%, 12.9%, 14.1%, 14.6%, and 15.4% of participants at Years 1-5 after diagnosis, respectively. Participants with the SxCl (SxCl (+)) were more likely to die than those without it; but this tendency diminished over time. SxCl persistence varied, with ≥40% of surviving patients annually transitioning to or from the SxCl(+) state until Year 4, after which the SxCl became increasingly stable. The SxCl was more likely to develop among male survivors who underwent surgery, received radiation, and were current smokers. CONCLUSION: A single SxCl comprising dyspnea, fatigue, and cough has a stable prevalence among LC survivors up to five years after diagnosis but is not stable among individuals. Initially, after diagnosis, the SxCl is associated with a greater risk of death; however, after Year 2, the SxCl becomes increasingly stable and provides a marker for parenchymal lung injury.


Assuntos
Carcinoma/complicações , Tosse/complicações , Dispneia/complicações , Fadiga/complicações , Neoplasias Pulmonares/complicações , Idoso , Carcinoma/diagnóstico , Tosse/diagnóstico , Autoavaliação Diagnóstica , Dispneia/diagnóstico , Fadiga/diagnóstico , Feminino , Humanos , Neoplasias Pulmonares/diagnóstico , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos , Inquéritos e Questionários
6.
J Am Coll Surg ; 211(5): 609-19, 2010 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-20851643

RESUMO

BACKGROUND: The relationships of working hours and nights on call per week with various parameters of distress among practicing surgeons have not been previously examined in detail. STUDY DESIGN: More than 7,900 members of the American College of Surgeons responded to an anonymous, cross-sectional survey. The survey included self-assessment of their practice setting, a validated depression screening tool, and standardized assessments of burnout and quality of life. RESULTS: There was a clear gradient between hours and burnout, with the prevalence of burnout ranging from 30% for surgeons working <60 hours/week, 44% for 60 to 80 hours/week, and 50% for those working >80 hours/week (p < 0.001). When correlated with number of nights on call, burnout exhibited a threshold effect at ≥2 nights on call/week (≤1 nights on call/week, 30%; ≥2 nights on call/week, 44% to 46%; p < 0.0001). Screening positive for depression rate also correlated strongly with hours and nights on call (both p < 0.0001). Those who worked >80 hours/week reported a higher rate of medical errors compared with those who worked <60 hours/week (10.7% versus 6.9%; p < 0.001), and were twice as likely to attribute the error to burnout (20.1% versus 8.9%; p = 0.001). Not surprisingly, work and home conflicts were higher among surgeons who worked longer hours or had ≥2 nights on call. A significantly higher proportion of surgeons who worked >80 hours/week or had >2 nights on call/week would not become a surgeon again (p < 0.0001). CONCLUSIONS: Number of hours worked and nights on call per week appear to have a substantial impact on surgeons, both professionally and personally. These factors are strongly related to burnout, depression, career satisfaction, and work and home conflicts.


Assuntos
Esgotamento Profissional/epidemiologia , Cirurgia Geral/organização & administração , Cirurgia Geral/estatística & dados numéricos , Carga de Trabalho/estatística & dados numéricos , Adulto , Plantão Médico , Estudos de Coortes , Feminino , Cirurgia Geral/classificação , Diretrizes para o Planejamento em Saúde , Humanos , Incidência , Satisfação no Emprego , Masculino , Erros Médicos/estatística & dados numéricos , Pessoa de Meia-Idade , Assistência Noturna , Vigilância da População , Estados Unidos/epidemiologia
7.
Clin Cancer Res ; 11(16): 5935-41, 2005 Aug 15.
Artigo em Inglês | MEDLINE | ID: mdl-16115936

RESUMO

PURPOSE: Flavopiridol, a cyclin-dependent kinase inhibitor, transcription inhibitor, and DNA-interacting agent, was combined with cisplatin or carboplatin to establish toxicities, evaluate pharmacokinetics, and examine its effects on patient cancers and levels of selected polypeptides in patient peripheral blood mononuclear cells (PBMC). EXPERIMENTAL DESIGN: Therapy was given every 3 weeks. Stage I: cisplatin was fixed at 30 mg/m2 with escalating flavopiridol. Stage II: flavopiridol was fixed at the stage I maximum tolerated dose (MTD) with escalation of cisplatin. Stage III: flavopiridol was fixed at the stage I MTD with escalation of carboplatin. RESULTS: Thirty-nine patients were treated with 136 cycles of chemotherapy. Neutropenia was seen in only 11% of patients. Grade 3 flavopiridol/CDDP toxicities were nausea (30%), vomiting (19%), diarrhea (15%), dehydration (15%), and neutropenia (10%). Flavopiridol combined with carboplatin resulted in unexpectedly high toxicities and one treatment-related death. Stable disease (>3 months) was seen in 34% of treated patients, but there were no objective responses. The stage II MTD was 60 mg/m2 cisplatin and 100 mg/m2/24 hours flavopiridol. As given, CDDP did not alter flavopiridol pharmacokinetics. Flavopiridol induced increased p53 and pSTAT3 levels in patient PBMCs but had no effects on cyclin D1, phosphoRNA polymerase II, or Mcl-1. CONCLUSIONS: Flavopiridol and cisplatin can be safely combined in the treatment of cancer patients. Unexpected toxicity in flavopiridol/carboplatin-treated patients attenuates enthusiasm for this alternative combination. Analysis of polypeptide levels in patient PBMCs suggests that flavopiridol may be affecting some, but not all, of its known in vitro molecular targets in vivo.


Assuntos
Protocolos de Quimioterapia Combinada Antineoplásica/uso terapêutico , Neoplasias/tratamento farmacológico , Adulto , Idoso , Protocolos de Quimioterapia Combinada Antineoplásica/efeitos adversos , Protocolos de Quimioterapia Combinada Antineoplásica/farmacocinética , Área Sob a Curva , Carboplatina/administração & dosagem , Carboplatina/efeitos adversos , Carboplatina/farmacocinética , Linhagem Celular Tumoral , Cisplatino/administração & dosagem , Cisplatino/efeitos adversos , Cisplatino/farmacocinética , Estudos de Coortes , Diarreia/induzido quimicamente , Relação Dose-Resposta a Droga , Feminino , Flavonoides/administração & dosagem , Flavonoides/efeitos adversos , Flavonoides/farmacocinética , Humanos , Immunoblotting , Leucócitos Mononucleares/efeitos dos fármacos , Leucócitos Mononucleares/metabolismo , Masculino , Pessoa de Meia-Idade , Náusea/induzido quimicamente , Neoplasias/sangue , Neoplasias/patologia , Piperidinas/administração & dosagem , Piperidinas/efeitos adversos , Piperidinas/farmacocinética , Proteínas Proto-Oncogênicas c-bcl-2/sangue , Fator de Transcrição STAT3/sangue , Resultado do Tratamento , Proteína Supressora de Tumor p53/sangue
8.
Cancer Epidemiol Biomarkers Prev ; 14(6): 1402-10, 2005 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-15941948

RESUMO

OBJECTIVE: Predictors of quality of life (QOL) in patients with metastatic colorectal cancer are lacking. The insulin-like growth factor (IGF) family of proteins is associated with QOL in noncancer populations. We sought to study whether these proteins are associated with QOL in patients with colorectal cancer. METHOD: We used a cohort of 526 patients with metastatic colorectal cancer treated with combination chemotherapy. Plasma samples of IGF-I, IGF-II, IGF binding protein-3, and C-peptide were collected before initiation of chemotherapy. QOL was measured by the uniscale instrument and the Symptom Distress Scale at baseline and throughout treatment. RESULTS: Baseline plasma levels of IGF-I and IGF-II before initiation of chemotherapy were significantly associated with several important baseline QOL measures in patients with metastatic colorectal cancer. Patients with lower levels of IGF-I reported increased distress with regard to appearance, appetite, cough, and nausea intensity after adjustment for potential confounders. Similarly, decreased levels of IGF-II were predictive of worse quality related to appearance, appetite, fatigue, nausea frequency and intensity, pain frequency, and composite Symptom Distress Scale score. IGF binding protein-3 and C-peptide were not predictive of baseline QOL. Baseline biomarkers were not associated with subsequent changes in QOL during treatment. Higher body mass index was significantly associated with superior baseline QOL in several areas; nonetheless, the association of IGF-I and IGF-II with baseline QOL measures remained significant even after controlling for baseline body mass index. CONCLUSION: Baseline plasma IGF-I and IGF-II are significantly associated with symptom distress. Whether this association is simply reflective of patient nutritional status and/or disease burden or represents an independent biological effect of IGFs on QOL remains uncertain. Nonetheless, these data suggest that molecular biomarkers may be useful predictors of QOL in cancer patients.


Assuntos
Biomarcadores Tumorais/sangue , Peptídeo C/sangue , Neoplasias Colorretais/patologia , Qualidade de Vida , Somatomedinas/análise , Protocolos de Quimioterapia Combinada Antineoplásica/uso terapêutico , Apetite , Estudos de Coortes , Neoplasias Colorretais/tratamento farmacológico , Neoplasias Colorretais/psicologia , Fadiga , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Náusea , Metástase Neoplásica , Satisfação do Paciente , Estresse Psicológico
9.
J Clin Oncol ; 21(20): 3761-9, 2003 Oct 15.
Artigo em Inglês | MEDLINE | ID: mdl-12963697

RESUMO

PURPOSE: We sought to determine the maximum-tolerated dose (MTD) and evaluate the toxicities and clinical activity of two irinotecan (CPT-11), fluorouracil (FU), leucovorin (LV), and oxaliplatin schedules in patients with advanced solid tumors. Additionally, we investigated the effect of CPT-11 on oxaliplatin pharmacokinetics. PATIENTS AND METHODS: Thirteen patients (cohort 1) received intravenous CPT-11 (infusion) and FU/LV (bolus) on days 1, 8, 15, and 22 and oxaliplatin (infusion) on days 1 and 15 every 6 weeks for a total 37 courses (median, three courses) at three dose levels. Twenty-two cohort 2 patients received intravenous CPT-11/oxaliplatin (infusion, day 1) and FU/LV (90-minute bolus infusion, days 2 to 5) every 3 weeks for a total of 122 courses (median, four courses) at three dose levels. Pharmacokinetic and neurotoxicity assessments were performed at the cohort 2 MTD. RESULTS: Dose-limiting toxicity (DLT) seen in both cohorts at the starting dose required dose de-escalation. Cohort 1 DLT included diarrhea and neutropenia. In cohort 2, diarrhea, vomiting, dehydration, neutropenia, febrile neutropenia, and paresthesias were DLTs. Antitumor activity was seen in both cohorts. In cohort 2, the total platinum area under the curve of patients increased 17% in cycle 2 (P =.048), but objective neurotoxicity was not seen. CONCLUSION: The toxicities resulting from the addition of oxaliplatin to CPT-11/FU/LV are significant but manageable. The MTDs for the weekly schedule are CPT-11 (75 mg/m2), oxaliplatin (50 mg/m2), FU (320 mg/m2), and LV (20 mg/m2); and, for the 3-weekly schedule, the MTDs are CPT-11 (175 mg/m2), oxaliplatin (85 mg/m2), FU (240 mg/m2), and LV (20 mg/m2). Second-cycle platinum accumulation raises the possibility for enhanced cumulative neurotoxicity with CPT-11/oxaliplatin combinations.


Assuntos
Protocolos de Quimioterapia Combinada Antineoplásica/uso terapêutico , Camptotecina/análogos & derivados , Neoplasias/tratamento farmacológico , Adulto , Idoso , Camptotecina/administração & dosagem , Camptotecina/efeitos adversos , Esquema de Medicação , Feminino , Fluoruracila/administração & dosagem , Fluoruracila/efeitos adversos , Humanos , Irinotecano , Leucovorina/administração & dosagem , Leucovorina/efeitos adversos , Masculino , Dose Máxima Tolerável , Pessoa de Meia-Idade , Neutropenia/induzido quimicamente , Compostos Organoplatínicos/administração & dosagem , Compostos Organoplatínicos/efeitos adversos , Oxaliplatina , Doenças do Sistema Nervoso Periférico/induzido quimicamente
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