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OBJECTIVES: Postmenopausal women (PMW) can experience side-effects (breast pain/tenderness and vaginal spotting/bleeding) associated with estrogen plus progestin therapies (EPTs). To assess these outcomes, the Breast Pain and Tenderness Daily Diary (BPT-DD) and the Vaginal Bleeding and Spotting Daily Diary (VBS-DD) were developed for electronic completion (eDiaries). This study evaluated the psychometric properties of the eDiaries. METHODS: The eDiaries were completed daily for 28 days by 202 PMW experiencing breast pain/tenderness and/or vaginal spotting/bleeding while on EPTs. Confirmatory factor analysis (CFA) investigated the BPT-DD structure. Response distributions, test-retest reliability (intraclass correlation coefficient [ICC]), internal consistency (BPT-DD only), and construct validity (via known groups and convergent validity analyses) were assessed. RESULTS: Completion rates were high: over 90% of women missed <3 daily entries. CFA supported the BPT-DD unidimensional structure (Bentler's Comparative Fit Index >0.98). BPT-DD inter-item correlations (r = 0.77-0.89) and internal consistency (Cronbach's alpha = 0.95-0.97) were high and good test-retest reliability was demonstrated (ICC ≥ 0.70). The eDiaries correlated moderately (>0.40), in a logical pattern with other instruments, supporting convergent validity. Known-groups analyses indicated both measures demonstrated significant differences between patients of differing severity (p < 0.001). CONCLUSION: The study provides evidence of strong psychometric properties for the BPT-DD and VBS-DD to assess breast pain/tenderness and spotting/bleeding in PMW.
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Terapia de Reposição de Estrogênios/efeitos adversos , Mastodinia/etiologia , Pós-Menopausa , Qualidade de Vida , Hemorragia Uterina/etiologia , Coleta de Dados/instrumentação , Feminino , Humanos , Pessoa de Meia-Idade , Psicometria , Reprodutibilidade dos Testes , Autorrelato , Inquéritos e QuestionáriosRESUMO
OBJECTIVES: Postmenopausal (PM) women taking therapies using estrogens plus progestogens (EPTs) can experience side effects (breast pain, vaginal spotting/bleeding). Sensitivity of the European Quality of Life Five Dimension Five Level (EQ-5D-5L) in measuring quality of life of PM women experiencing side effects of EPTs is unknown. A crosswalk between the Menopause-Specific Quality of Life (MENQOL) questionnaire and the EQ-5D-5L was assessed. METHODS: The measures were administered to 352 PM women (side effects = 202; control = 75; untreated = 75) in a non-interventional study. MENQOL total scores, treated as continuous and categorical predictors, were mapped onto EQ-5D-5L utilities using regression. Ordinary least-squares regression using averaged scores over time, goodness of fit, and estimated coefficients was also assessed. RESULTS: Mean age was 53.7 years. The first model (MENQOL as a continuous variable) showed a moderate correlation (-0.589) and statistically significant relationship with the EQ-5D-5L (p < 0.001), with an equation of EQ-5D-5L = 0.992 - 0.042 × MENQOL. The EQ-5D-5L mean scores were comparable (side effects = 0.854; control = 0.927; untreated = 0.836) to MENQOL mean scores estimated in the first model (side effects = 0.865 [standard deviation 0.07]; control = 0.909; untreated = 0.833). Linearity assumptions were supported with MENQOL scores as a categorical predictor. Goodness of fit was moderate (R2 = 0.347; root mean squared error = 0.093). CONCLUSION: The crosswalk supports conversion of MENQOL scores to EQ-5D-5L-derived health utilities for group-level analyses in PM women.
Assuntos
Nível de Saúde , Pós-Menopausa , Qualidade de Vida , Inquéritos e Questionários , Feminino , Serviços de Saúde/normas , Humanos , Análise dos Mínimos Quadrados , Pessoa de Meia-Idade , Modelos Teóricos , Medidas de Resultados Relatados pelo Paciente , Psicometria/métodos , Índice de Gravidade de Doença , Saúde da MulherRESUMO
The value of adding simeprevir (SMV) vs placebo (PBO) to peginterferon and ribavirin (PR) for treatment of chronic hepatitis C virus infection was examined using patient-reported outcomes (PROs); further, concordance of PROs with virology endpoints and adverse events (AEs) was explored. Patients (n = 768 SMV/PR, n = 393 PBO/PR) rated fatigue (FSS), depressive symptoms (CES-D) and functional impairment (WPAI: Hepatitis C Productivity, Daily Activity and Absenteeism) at baseline and throughout treatment in three randomised, double-blind trials comparing the addition of SMV or PBO during initial 12 weeks of PR. PR was administered for 48 weeks (PBO group) and 24/48 weeks (SMV group) using a response-guided therapy (RGT) approach. Mean PRO scores (except Absenteeism) worsened from baseline to Week 4 to the same extent in both groups but reverted after Week 24 for SMV/PR and only after Week 48 for PBO/PR. Accordingly, there was a significantly lower area under the curve (baseline-Week 60, AUC60 ) and fewer weeks with clinically important worsening of scores in the SMV/PR group at any time point. Incidences of patients with fatigue and anaemia AEs were similar in both groups, but FSS scores showed that clinically important increases in fatigue lasted a mean of 6.9 weeks longer with PBO/PR (P < 0.001). PRO score subgroup analysis indicated better outcomes for patients who met the criteria for RGT or achieved sustained virological response 12 weeks post-treatment (SVR12); differences in mean PRO scores associated with fibrosis level were only observed with PBO/PR. Greater efficacy of SMV/PR enabled reduced treatment duration and reduced time with PR-related AEs without adding to AE severity.
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Depressão/epidemiologia , Fadiga/epidemiologia , Hepatite C Crônica/tratamento farmacológico , Interferons/administração & dosagem , Ribavirina/administração & dosagem , Simeprevir/administração & dosagem , Adolescente , Adulto , Idoso , Anemia/epidemiologia , Método Duplo-Cego , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/epidemiologia , Feminino , Hepatite C Crônica/complicações , Humanos , Incidência , Interferons/efeitos adversos , Fígado/patologia , Masculino , Pessoa de Meia-Idade , Placebos/administração & dosagem , Ribavirina/efeitos adversos , Simeprevir/efeitos adversos , Resultado do Tratamento , Carga Viral , Adulto JovemRESUMO
BACKGROUND: Approximately 7-10% of Parkinson's disease (PD) patients carry a GBA (Glucocerebrosidase) mutation (GBA-PD patients), which may influence the disease's clinical course. OBJECTIVES: This study aimed to explore the patient experience of GBA-PD and identify the most important symptoms and impacts to inform clinical trial measurement strategies. METHODS: Twenty PD patients (n = 15 GBA-PD; n = 5 idiopathic-PD) participated in qualitative interviews which explored concepts spontaneously reported or identified through a literature review. Telephone interviews with five expert clinicians included discussion of a preliminary conceptual model derived from literature. Verbatim transcripts were thematically analysed. RESULTS: Thirty symptoms reported by patients were categorized as motor, non-motor, and cognitive/psychiatric. Tremor (n = 13), memory loss (n = 13), rigidity/stiffness (n = 11), and speech problems (n = 11) were considered the most important and impactful symptoms by GBA-PD patients, although other symptoms were also relevant to the majority of patients. Key impacts included: sleep disturbances (n = 13), handwriting changes (n = 13), reduced social interaction (n = 12), dyskinesia (n = 10), depressed mood (n = 9), and fear of falling (n = 8). Key symptoms and impacts reported by GBA-PD patients were consistent with those reported by idiopathic-PD patients. Clinician interview results supported the patient findings, although some clinicians indicated that cognitive/psychiatric symptoms may present earlier in GBA-PD patients. The concepts emerging from the research informed updates to a conceptual model of GBA-PD patients' disease experience. CONCLUSIONS: The findings provide in-depth understanding of the patient experience of GBA-PD. The findings confirm that the concepts relevant to assess in GBA-PD are consistent with those relevant to assess in idiopathic-PD; however, greater consideration of cognitive/psychiatric symptoms may be warranted in GBA-PD populations.
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BACKGROUND: Although gas-related symptoms (GRS) are common and intrusive, there are no questionnaires to quantitate this problem. This study aimed to develop an instrument to rectify this gap in our knowledge. METHODS: Concepts were initially identified from the literature and interviews with gastroenterologists. Exploratory one-to-one interviews and focus groups with irritable bowel syndrome (IBS) patients (n = 28) and non-IBS subjects (n = 27) with GRS were conducted in UK, France, and Spain leading to a conceptual framework for the questionnaire. Last, iterative rounds of cognitive debriefing were performed with IBS (n = 16) and non-IBS subjects (n = 14). KEY RESULTS: From the first three steps, nine GRS (bloating, distension, flatulence, odorous flatulence, difficult gas evacuation, stomach rumbling, belching, bad breath, and abdominal movement) were identified although abdominal movement was subsequently excluded. Twelve quality of life domains affected by these symptoms were identified as: Clothing, emotional, physical appearance, diet, daily living, work, social life, physical activity, relationships, sex life, sleep, and cognitive function. A 24-h recall for symptoms and a 7-day recall for impact assessment were supported by the qualitative findings. Cognitive debriefing confirmed the understanding of the instrument. Across the three languages, the instrument was conceptually and linguistically consistent. CONCLUSIONS & INFERENCES: The International Gas Questionnaire is a 2-part instrument, developed rigorously and simultaneously in three languages assessing seven symptoms (17 items) and their impact on 12 domains (26 items) in IBS and general population. It is now undergoing psychometric validation and should provide a unique tool for epidemiological surveys and clinical trials for developing new treatments for these symptoms.
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Eructação , Flatulência , Síndrome do Intestino Irritável , Qualidade de Vida , Adolescente , Adulto , Idoso , Idoso de 80 Anos ou mais , Estudos de Casos e Controles , Feminino , Grupos Focais , Halitose , Nível de Saúde , Humanos , Masculino , Pessoa de Meia-Idade , Odorantes , Pesquisa Qualitativa , Inquéritos e Questionários , Adulto JovemRESUMO
We undertook a prospective cohort study to evaluate the role of a multifaceted infection control policy including the use of a "vancomycin order form," in decreasing the transmission of vancomycin-resistant enterococci (VRE). In January 1997, a multifaceted infection-control policy was implemented amongst patients admitted to the M. D. Anderson Cancer Center in whom neutropenic fever developed or who were found to be colonized or infected with VRE. As part of this programme, we initiated the use of a vancomycin order form to reduce the use of empirical vancomycin. The total incidence of VRE infections declined from 0.437/1000 patient days in 1996-97 to 0.229/1000 patient days in 1998-99 (P=0.008). The VRE bloodstream infections declined from 0.338/1000 patient days in 1996-97 to 0.181/1000 patient days in 1998-99 (P=0.027). Empiric vancomycin use decreased from 416 g/1000 patient days in 1996-97 to 208 g/1000 patient days in 1998-99 (P<0.001), resulting in a decreased vancomycin cost from $2561 US dollars/1000 patient days in 1996-97 to $1195 US dollars/1000 patient days in 1997-98 (P<0.001). We conclude that a multifaceted infection control policy incorporating the use of a vancomycin order form can effectively decrease the use of empirical vancomycin and can play a role in limiting the spread of VRE in an endemic setting.
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Antibacterianos/uso terapêutico , Institutos de Câncer , Infecção Hospitalar/prevenção & controle , Enterococcus/efeitos dos fármacos , Controle de Infecções , Resistência a Vancomicina , Vancomicina/uso terapêutico , Infecção Hospitalar/epidemiologia , Enterococcus/isolamento & purificação , Humanos , Incidência , Estudos Prospectivos , Texas/epidemiologiaRESUMO
This paper outlines briefly the background of the International Eye Foundation and the origins of the Kenya Rural Blindness Prevention Project (KRBPP). It examines in some detail the major objectives of the project and the activities which have contributed toward the achievement of those objectives. Objectives of the KRBPP include the strengthening of therapeutic services in rural areas, motivating a re-orientation toward preventive education and away from exclusively curative services and the development of appropriate educational and promotional materials on primary eye care and blindness prevention. The activities of the project have included the development of mobile rural blindness prevention units, the provision of training to health workers at all levels, curricula development for use in health training institutions and the development of a variety of educational and promotional materials for use by health workers, school teachers, students and the general public. It is suggested that the KRBPP can serve as a model for the development of similar national blindness prevention projects throughout the developing world.
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Cegueira/prevenção & controle , Pessoal Técnico de Saúde/educação , Humanos , Quênia , Oftalmologia/educação , Saúde da População RuralAssuntos
Hemoglobinas/análise , Peptídeos/análise , Animais , Cromatografia em Papel , Densitometria , Eletroforese , SuínosRESUMO
PURPOSE: Diarrhea is one of the dose-limiting toxicities associated with chemotherapy agents in treatment regimens for colorectal cancer. The objectives of this study were to analyze the impact of all grades of diarrhea on clinical decisions for patients receiving treatment for colorectal cancer by characterizing the diarrhea that occurred, quantifying changes in chemotherapy treatment, identifying methods to treat diarrhea, and determining the economic impact. Patients and Methods. We retrospectively reviewed the treatment of 100 consecutive patients with colorectal cancer who experienced diarrhea during the course of chemotherapy. The diarrhea was documented in the progress notes and graded according to National Cancer Institute Common Toxicity Criteria. Changes in chemotherapy treatment and resource utilization associated with diarrhea were recorded. RESULTS: The 100 patients received 673 chemotherapy cycles, of which 45% +/- 2% were associated with diarrhea. Approximately 52% of patients experienced diarrhea of grades 3 or 4, and 56 patients underwent 66 modifications in their chemotherapy treatment, such as dose reductions (22), delays in therapy (8), discontinuations of therapy (15), or multiple changes (11). Thirty-seven patients consumed resources beyond oral antidiarrheals to control diarrhea: 14 patients received emergency outpatient treatment, 23 patients were hospitalized, 21 patients received intravenous fluids, and one death due to dehydration was reported. Discussion and Conclusion. Diarrhea was a significant consequence of colorectal chemotherapy, with the majority of patients experiencing grades 3 or 4 diarrhea and 56% of all patients also modifying their chemotherapy treatment. Even mild diarrhea of grades 1 and 2 was associated with changes in treatment in 11% of patients; thus, diarrhea of all grades should be recognized and treated appropriately to maintain full-dose chemotherapy.
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Protocolos de Quimioterapia Combinada Antineoplásica/efeitos adversos , Neoplasias Colorretais/tratamento farmacológico , Diarreia/etiologia , Adulto , Idoso , Antidiarreicos/uso terapêutico , Protocolos de Quimioterapia Combinada Antineoplásica/uso terapêutico , Desidratação/etiologia , Diarreia/complicações , Diarreia/patologia , Esquema de Medicação , Feminino , Hospitalização , Humanos , Masculino , Pessoa de Meia-Idade , Estudos RetrospectivosRESUMO
BACKGROUND: The purpose of this study was to describe canalicular stenosis as a mechanism for epiphora (excessive tearing) secondary to weekly docetaxel. PATIENTS AND METHODS: Fourteen patients with metastatic breast cancer who developed epiphora during weekly docetaxel therapy underwent an ophthalmologic examination, and probing and irrigation of the nasolacrimal ducts. The total duration of docetaxel therapy, the duration of treatment at the time of onset of epiphora, the number of infusions, the cumulative dose of docetaxel and the severity of canalicular stenosis were recorded. RESULTS: All 14 patients had anatomic narrowing of the canaliculi as the underlying mechanism for epiphora. Bicanalicular silicone intubation or dacryocystorhinostomy (DCR) was recommended for all 14 patients. Eleven patients underwent surgery and experienced resolution of their symptoms. The three patients who declined surgery continue to have epiphora at the time of this report. CONCLUSIONS: Canalicular stenosis is an underlying mechanism for epiphora in patients receiving weekly docetaxel. Bicanalicular silicone intubation should be considered early in the course of weekly docetaxel therapy to prevent complete closure of the canaliculi. Once complete or near complete stenosis of the canaliculi occurs, DCR with a permanent pyrex glass tube placement may become necessary to overcome the blockage of tear outflow.