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1.
Health Qual Life Outcomes ; 16(1): 111, 2018 May 31.
Artigo em Inglês | MEDLINE | ID: mdl-29855366

RESUMO

BACKGROUND: Anemia is a common and debilitating manifestation of chronic kidney disease (CKD). Data from two clinical trials in patients with anemia of CKD were used to assess the measurement properties of the Medical Outcomes Survey Short Form-36 version 2 (hereafter SF-36) and the Functional Assessment of Cancer Therapy-Anemia (FACT-An). The Vitality and Physical functioning domains of the SF-36 and the FACT-An Total, Fatigue and Anemia subscales were identified as domains relevant to CKD-associated anemia. METHODS: A total of 204 patients aged 18-80 years were included in the analyses that included internal consistency (Cronbach's alpha), test-retest reliability (intraclass correlation coefficients [ICCs]), convergent and known-groups validity, responsiveness, and estimates of important change. RESULTS: Both the SF-36 and the FACT-An had strong psychometric properties with high internal consistency (Cronbach's alpha: 0.69-0.93 and 0.79-0.95), and test-retest reliability (ICCs: 0.64-0.83 and 0.72-0.88). Convergent validity, measured by correlation coefficients between similar concepts in SF-36 and FACT-An, ranged from 0.52 to 0.77. Correlations with hemoglobin (Hb) levels were modest at baseline; by Week 9, the correlations with Hb were somewhat higher, r = 0.23 (p < 0.05) for SF-36 Vitality, r = 0.22 (p < 0.05) for FACT-An Total, r = 0.26 (p < 0.001) for FACT-Fatigue and r = 0.22 (p < 0.01) for Anemia. Correlations with Hb at Week 13/17 were r = 0.28 (p < 0.001) for SF-36 Vitality and r = 0.25 (p < 0.05) for Role Physical; FACT-An Total correlation was r = 0.33 (p < 0.0001), Anemia was r = 0.28 (p < 0.001), and Fatigue was r = 0.30 (p < 0.001). The SF-36 domains and Component Summary scores (p < 0.05-p < 0.0001) demonstrated ability to detect change. For the FACT-An, significant differences (p < 0.05-p < 0.0001) were observed between responder and non-responder change scores: important change score estimates ranged from 2 to 4 for Vitality and 2-3 for Physical functioning. Important change scores were also estimated for the FACT-An Total score (6-9), the Anemia (3-5), and Fatigue subscale (2-4). CONCLUSIONS: Both the SF-36 Vitality and Physical function scales and the FACT-An Total, Fatigue and Anemia scales, are reliable and valid measures for assessing health-related quality of life in anemia associated with CKD.


Assuntos
Anemia/psicologia , Qualidade de Vida , Insuficiência Renal Crônica/psicologia , Inquéritos e Questionários/normas , Adulto , Idoso , Idoso de 80 Anos ou mais , Anemia/etiologia , Fadiga/diagnóstico , Fadiga/etiologia , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Psicometria , Insuficiência Renal Crônica/complicações , Reprodutibilidade dos Testes , Adulto Jovem
3.
Pain Res Treat ; 2017: 6080648, 2017.
Artigo em Inglês | MEDLINE | ID: mdl-28191351

RESUMO

Background. The Self-Assessment of Treatment version II (SAT II) measures treatment-related improvements in pain and impacts and impressions of treatment in neuropathic pain patients. The measure has baseline and follow-up versions. This study assesses the measurement properties of the SAT II. Methods. Data from 369 painful diabetic peripheral neuropathy (PDPN) patients from a phase III trial assessing capsaicin 8% patch (Qutenza®) efficacy and safety were used in these analyses. Reliability, convergent validity, known-groups validity, and responsiveness (using the Brief Pain Inventory-Diabetic Neuropathy [BPI-DN] and Patient Global Impression of Change [PGIC]) analyses were conducted, and minimally important differences (MID) were estimated. Results. Exploratory factor analysis supported a one-factor solution for the six impact items. The SAT II has good internal consistency (Cronbach's alpha: 0.96) and test-retest reliability (intraclass correlation coefficients: 0.62-0.88). Assessment of convergent validity showed moderate to strong correlations with change in other study endpoints. Scores varied significantly by level of pain intensity and sleep interference (p < 0.05) defined by the BPI-DN. Responsiveness was shown based on the PGIC. MID estimates ranged from 1.2 to 2.4 (pain improvement) and 1.0 to 2.0 (impact scores). Conclusions. The SAT II is a reliable and valid measure for assessing treatment improvement in PDPN patients.

4.
BMC Nephrol ; 17(1): 97, 2016 07 26.
Artigo em Inglês | MEDLINE | ID: mdl-27460779

RESUMO

BACKGROUND: Deteriorating renal function in chronic kidney disease (CKD) patients is commonly associated with reduced haemoglobin levels, adding to the already considerable humanistic burden of CKD. This analysis evaluated the impact of anaemia on disease burden in patients with CKD stages 3-4, and in those on dialysis. METHODS: This was a descriptive, cross-sectional analysis of European data from an Adelphi CKD Disease-Specific Programme. This programme collected data from patients and their treating nephrologists/endocrinologists; patient- and physician-reported data were matched for each patient. Health-related quality of life (HRQoL) data were obtained through patient completion of the EQ-5D, SF-12 and KDQOL-36. Additional information was obtained via physician reporting of patient symptoms, and patients' reports of impaired activity. Anaemia was defined by haemoglobin level and/or current use of erythropoiesis stimulating agents. RESULTS: Significant, but modest Spearman's rank correlations were observed between haemoglobin levels and extent of HRQoL impairment, regardless of instrument used (range 0.19-0.23; all P-values < 0.0001). When stratified by anaemia status, impairment was consistently lower for anaemic than non-anaemic CKD patients across measurement scales (e.g. EQ-5D index value [standard deviation {SD}] 0.72 [0.31] vs 0.83 [0.23], respectively; P < 0.0001). Physician-reported patient tiredness was associated with increased disease burden at all levels of CKD studied (total EQ-5D index value [SD] in patients reporting no tiredness vs tiredness 0.81 [0.26] vs 0.70 [0.30] respectively; P < 0.0001) with P < 0.0001 for no tiredness vs tiredness at all stages of CKD. The presence of anaemia was associated with impaired activity levels at CKD stages 3 (37.5 % vs 28.4 %, respectively; P = 0.0044) and 4 (48.1 % vs 39.9 %, respectively; P = 0.0292), and in patients on dialysis (52.0 % vs 45.0 %, respectively; P = 0.0732). CONCLUSIONS: The analysis found that CKD patients with anaemia typically had a lower HRQoL than those without anaemia. The impairment correlated with anaemia was more apparent in non-dialysis patients with CKD stages 3 or 4 than in those receiving dialysis. Coexisting CKD and anaemia may have an impact on patient HRQoL similar to other chronic conditions such as diabetes, epilepsy or certain forms of cancer.


Assuntos
Anemia/sangue , Efeitos Psicossociais da Doença , Hemoglobinas/metabolismo , Qualidade de Vida , Insuficiência Renal Crônica/complicações , Idoso , Idoso de 80 Anos ou mais , Anemia/etiologia , Estudos Transversais , Endocrinologia , Europa (Continente) , Fadiga/sangue , Fadiga/etiologia , Feminino , Barreira de Filtração Glomerular , Hematínicos/uso terapêutico , Humanos , Masculino , Pessoa de Meia-Idade , Nefrologia , Diálise Renal , Insuficiência Renal Crônica/fisiopatologia , Insuficiência Renal Crônica/terapia , Autorrelato , Avaliação de Sintomas
5.
Diabetes Res Clin Pract ; 109(2): 215-25, 2015 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-26008721

RESUMO

AIMS: Painful diabetic peripheral neuropathy (PDPN) is a common complication of diabetes mellitus. A systematic literature review was conducted to provide an overview of published literature in the last 10-years on the epidemiology, humanistic burden and economic burden of PDPN in Europe. METHODS: A search was performed according to pre-defined strategy and review criteria in Embase, Pubmed, and conference proceedings databases from 2003 till December 2012. In total, 30 publications written in English covering the relevant patient population and topics of interest. RESULTS: European prevalence ranges from 6% to 34% in diabetes mellitus patients. PDPN has a significant humanistic and economic impact. Patients are limited in their general functioning and their ability to sleep and often experience anxiety and depression. Not surprisingly, PDPN is associated with reduced Health-Related-Quality-of-Life (HRQoL). PDPN patients incur high health care costs due to hospitalizations and outpatient visits. In addition, the painful symptoms cause impaired work productivity. Studies suggest both humanistic and economic burden increase with higher pain severity. CONCLUSIONS: The burden from PDPN appears to be higher with increasing pain severity. More severe pain leads to a higher impairment in daily functioning, sleep and HRQoL. Higher pain intensity also leads to increasing healthcare costs and work productivity losses.


Assuntos
Neuropatias Diabéticas , Custos de Cuidados de Saúde , Qualidade de Vida , Efeitos Psicossociais da Doença , Neuropatias Diabéticas/economia , Neuropatias Diabéticas/epidemiologia , Neuropatias Diabéticas/psicologia , Europa (Continente)/epidemiologia , Humanos , Prevalência
6.
J Comp Eff Res ; 2(1): 33-44, 2013 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-24236519

RESUMO

Although comparative effectiveness has received considerable attention recently - especially in the USA - it is not a new concept. In Europe, it has been applied for some time now in the pricing and reimbursement processes of many countries. Each one uses it in its own way, however, with variations in the precise definition and the role it plays in the process. It remains to be seen whether the implementation of comparative effectiveness becomes more harmonized and whether it will be integrated better with the registration process. Regardless of the extent to which it is standardized, obtaining the data will remain a substantial hurdle, both methodologically and operationally. Everyone wants comparative effectiveness information but no one knows quite how to make it happen.


Assuntos
Pesquisa Comparativa da Efetividade , Custos de Medicamentos , Mecanismo de Reembolso , Custos e Análise de Custo , França , Alemanha , Humanos , Itália , Países Baixos , Reino Unido
7.
J Med Econ ; 16(3): 342-8, 2013.
Artigo em Inglês | MEDLINE | ID: mdl-23216016

RESUMO

BACKGROUND: Omalizumab, licensed for patients with uncontrolled persistent allergic (IgE mediated) asthma, was found to be cost-effective based upon its clinical trial data. Observational studies have been undertaken to determine the real life outcomes of using omalizumab in the community. OBJECTIVE: To determine the cost-effectiveness of omalizumab based upon observational data from the Netherlands and compare to its cost-effectiveness using clinical trial data. METHODS: An observational study (eXpeRience) recruited allergic asthma patients eligible for Omalizumab therapy and followed them while on treatment. At 1 year, data from the Dutch patients enrolled in eXpeRience were examined to estimate the number of exacerbations and resource use while on omalizumab therapy compared to the year prior to omalizumab use. Observational data were used in a Markov model to calculate the lifetime cost-effectiveness ratios. RESULTS: In the 1 year prior to omalizumab therapy the per-person rate of exacerbations was 3.39 compared to 1.07 in the year taking omalizumab. The discounted incremental lifetime additional costs for omalizumab were €55,865 for 1.46 additional quality-adjusted life years (QALY), resulting in €38,371/QALY. Using the INNOVATE clinical trial outcomes and current resource use, the prior ratio was €34,911/QALY, similar to the observational ratio. As in all observational studies, the main limitation is obtaining complete and accurate data. Patients with missing exacerbation or response data were excluded from this analysis. CONCLUSION: Non-clinical trial experience with omalizumab supported the finding of fewer exacerbations in the allergic asthma population while treated with omalizumab, and therapy was found to continue to have an attractive cost-effectiveness ratio.


Assuntos
Antiasmáticos/economia , Anticorpos Anti-Idiotípicos/economia , Anticorpos Monoclonais Humanizados/economia , Asma/tratamento farmacológico , Adolescente , Adulto , Idoso , Antiasmáticos/uso terapêutico , Anticorpos Anti-Idiotípicos/uso terapêutico , Anticorpos Monoclonais Humanizados/uso terapêutico , Análise Custo-Benefício/métodos , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Países Baixos , Omalizumab , Qualidade de Vida , Anos de Vida Ajustados por Qualidade de Vida , Sistema de Registros , Inquéritos e Questionários , Adulto Jovem
8.
Drug Discov Today ; 17(11-12): 615-22, 2012 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-22366662

RESUMO

Healthcare decision makers who determine funding for new medical technologies depend on manufacturers to provide evidence of the technology's efficacy, safety and cost-effectiveness. Constrained budgets and increasing reliance on formal health technology assessment (HTA) have created an abundance of external hurdles that manufacturers must navigate to ensure successful product commercialization. These demands have pushed pharmaceutical companies to adjust their internal structures to coordinate generation of appropriate evidence. In this article we summarize internal and external opportunities for manufacturers to establish a foundation of evidence for successful market access, starting in Phase I of development and continuing throughout the post-approval product lifecycle.


Assuntos
Biofarmácia/economia , Pesquisa Comparativa da Efetividade , Descoberta de Drogas/economia , Reembolso de Seguro de Saúde , Marketing/economia , Avaliação de Resultados em Cuidados de Saúde/economia , Avaliação da Tecnologia Biomédica/economia , Análise Custo-Benefício , Humanos , Ensaios Clínicos Controlados Aleatórios como Assunto
9.
Pharmacoeconomics ; 29(11): 917-32, 2011 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-21988291

RESUMO

Economic evaluations of chronic obstructive pulmonary disease (COPD) incorporate utilities through multi-attribute utility (MAU) measures, most commonly the EQ-5D, to report health-related quality-of-life (HR-QOL) changes or differences. Questions have been raised about the sensitivity of these measures in COPD. Limitations in detecting adequate patient-level changes in HR-QOL over time in stable and exacerbation states compared with disease-specific instruments could also result in underestimation of known treatment benefits. The purpose of this article was to present and discuss the empirical evidence on the validity of generic MAU measures within the COPD population. We built upon a previously conducted validation review for the period 1997-2007 that used 'respiratory disease' and 'EQ-5D' as keywords. For this discussion, PubMed and EMBASE databases were searched for articles in English from 1988 to August 2009, using similar search words. Based on the performance of MAU measures in COPD and exacerbations, they appear to have limited discriminatory ability, particularly between moderate and severe COPD, despite known differences in HR-QOL. Sensitivity to clinically relevant change in stable COPD over time due to treatment also appears limited. Current research suggests adequate sensitivity regarding detecting the onset and resolution of an exacerbation; however, sensitivity is limited in the short term, such as daily changes in health status. The evidence suggests responsiveness of MAU measures may be restricted to large within-patient change, which leads to difficulties in evaluating the subtle but important impact of exacerbations. Studies presenting alternative methods of deriving COPD-related utilities are also discussed. Overall, the insensitivities of generic MAU measures in COPD can lead to biased cost-effectiveness analyses and ill-informed economic decisions. Alternative measures such as condition-specific preference-based measures may be used in circumstances where more sensitivity is needed. The trade-off allows relevant and sensitive matters most important to patients to be evaluated; however inevitable gaps such as those related to adverse events are not considered.


Assuntos
Análise Custo-Benefício/métodos , Avaliação de Resultados em Cuidados de Saúde/economia , Avaliação de Resultados em Cuidados de Saúde/métodos , Doença Pulmonar Obstrutiva Crônica/economia , Estudos de Avaliação como Assunto , Nível de Saúde , Humanos , Doença Pulmonar Obstrutiva Crônica/terapia , Qualidade de Vida , Reprodutibilidade dos Testes , Sensibilidade e Especificidade
10.
J Med Econ ; 13(2): 241-56, 2010.
Artigo em Inglês | MEDLINE | ID: mdl-20438399

RESUMO

OBJECTIVE: To assess the health-related quality of life (HRQL) and economic burden of chronic kidney disease (CKD) related anemia in non-dialysis patients in the United States (US) via literature review. METHODS: MEDLINE, EMBASE, PROQOLID, and Cochrane Library/Renal Group Resources were searched. Studies were appraised for patient populations, disease-specific versus generic HRQL assessments, and type and magnitude of health-related costs. RESULTS: The treatment costs for CKD patients with anemia compared to those without anemia were significantly higher and were blunted but persistent after controlling for comorbidities and confounders. Intervention with erythropoiesis stimulating agents (ESA) decreased anemia and avoided hospital admissions. Costs were higher when anemia was poorly controlled or untreated. HRQL burden was mainly due to physical limitations and difficulty in ability to perform activities of daily living. Significant positive correlations between increases in hemoglobin levels and HRQL measures were reported. CONCLUSIONS: Although evidence is limited, the economic and HRQL burden of non-dialysis CKD-related anemia is substantial. Under-treatment of anemia may contribute to higher resource consumption and higher costs; however, patient co-morbidities, use of erythropoietin-stimulating agents, and overall management introduce potential confounds. The contribution of anemia to humanistic disease burden is due to a constellation of factors, including physical activity and functional status.


Assuntos
Anemia/economia , Anemia/etiologia , Falência Renal Crônica/complicações , Falência Renal Crônica/economia , Qualidade de Vida , Anemia/psicologia , Custos e Análise de Custo , Hematínicos/economia , Hospitalização/estatística & dados numéricos , Humanos , Falência Renal Crônica/psicologia , Estados Unidos
11.
Int J Chron Obstruct Pulmon Dis ; 3(3): 443-51, 2008.
Artigo em Inglês | MEDLINE | ID: mdl-18990973

RESUMO

INTRODUCTION: In contrast with the frequency distribution of chronic obstructive pulmonary disease (COPD) stages in the population, in which the majority of the patients is classified as GOLD 2, much less information is available on the prevalence and implications of systemic manifestations in less severe patients relative to GOLD 3 and 4. AIM: To characterize local and systemic impairment in relation to disease burden in a group of GOLD 2 COPD patients (n = 127, forced expiratory volume in one second (SD): 67 (11)% pred) that were eligible for the Interdisciplinary Community-based COPD management (INTERCOM) trial. METHODS: Patients were included for this lifestyle program based on a peak exercise capacity (Wmax) < 70% of predicted. Metabolic and ventilatory response to incremental cycle ergometry, 6 minute walking distance (6MWD), constant work rate test (CWR), lung function, maximal inspiratory pressure (Pimax), quadriceps force (QF), quadriceps average power (QP) (isokinetic dynamometry), handgrip force (HGF) and body composition were measured. Quality of life (QoL) was assessed by the St. George's Respiratory Questionnaire (SGRQ) and dyspnea by the modified Medical Research Council (MRC) dyspnea scale. Exacerbations and COPD-associated hospital admissions in 12 months prior to the start of the study were recorded. Burden of disease was defined in terms of exercise capacity, QoL, hospitalization, and exacerbation frequency. GOLD 2 patients were compared with reference values and with GOLD 3 patients who were also included in the trial. RESULTS: HGF (77.7 (18.8) % pred) and Pimax (67.1 (22.5)% pred) were impaired in GOLD 2, while QF (93.5 (22.5)% pred) was only modestly decreased. Depletion of FFM was present in 15% of weight stable GOLD 2 patients while only 2% had experienced recent involuntary weight loss. In contrast to Wmax, submaximal exercise capacity, muscle function, and body composition were not significantly different between GOLD 2 and 3 subgroups. Body mass index and fat-free mass index were significantly lower in smokers compared to ex-smokers. In multivariate analysis, QF and diffusing capacity (DLco) were independently associated with Wmax and 6 MWD in GOLD 2 while only 6 MWD was identified as an independent determinant of health-related QoL. HGF was an independent predictor of hospitalization. CONCLUSIONS: This study shows that also in patients with moderate COPD, eligible for a lifestyle program based on a decreased exercise capacity, systemic impairment is an important determinant of disease burden and that smoking affects body composition.


Assuntos
Efeitos Psicossociais da Doença , Comportamentos Relacionados com a Saúde , Doença Pulmonar Obstrutiva Crônica/reabilitação , Idoso , Composição Corporal , Índice de Massa Corporal , Análise Custo-Benefício , Tolerância ao Exercício , Feminino , Hospitalização/estatística & dados numéricos , Humanos , Estilo de Vida , Masculino , Pessoa de Meia-Idade , Doença Pulmonar Obstrutiva Crônica/classificação , Doença Pulmonar Obstrutiva Crônica/fisiopatologia , Doença Pulmonar Obstrutiva Crônica/prevenção & controle , Abandono do Hábito de Fumar
12.
Pharmacoeconomics ; 25(8): 695-711, 2007.
Artigo em Inglês | MEDLINE | ID: mdl-17640111

RESUMO

RATIONALE: Roflumilast is an oral, once-daily phosphodiesterase IV (PDE4) inhibitor under investigation for chronic obstructive pulmonary disease (COPD). This study investigated the cost effectiveness of roflumilast in patients with severe to very severe COPD from the perspective of the UK society and UK NHS. METHODS: The analysis was conducted alongside a 1-year, randomised, double-blind, placebo-controlled, multinational trial. The trial included 1514 COPD patients aged >or=40 years with a post-bronchodilator forced expiratory volume in 1 second (FEV1) % predicted

Assuntos
Aminopiridinas/uso terapêutico , Benzamidas/uso terapêutico , Inibidores de Fosfodiesterase/uso terapêutico , Doença Pulmonar Obstrutiva Crônica/tratamento farmacológico , Idoso , Aminopiridinas/economia , Benzamidas/economia , Análise Custo-Benefício , Ciclopropanos/economia , Ciclopropanos/uso terapêutico , Método Duplo-Cego , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos , Doença Pulmonar Obstrutiva Crônica/psicologia , Qualidade de Vida
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