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1.
Ann Hematol ; 103(6): 1931-1940, 2024 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-38478023

RESUMO

Ruxolitinib is beneficial in patients with myelofibrosis (MF) and polycythemia vera (PV). Information on ruxolitinib adherence is scant. The Ruxolitinib Adherence in Myelofibrosis and Polycythemia Vera (RAMP) prospective multicenter study (NCT06078319) included 189 ruxolitinib-treated patients. Patients completed the Adherence to Refills and Medications Scale (ARMS) and Distress Thermometer and Problem List (DTPL) at the earliest convenience, after registration in the study, and at later timepoints. At week-0, low adherence (ARMS > 14) and high distress (DT ≥ 4) were declared by 49.7% and 40.2% of patients, respectively. The main reason for low adherence was difficult ruxolitinib supply (49%), intentional (4.3%) and unintentional (46.7%) non-take. In multivariable regression analysis, low adherence was associated to male sex (p = 0.001), high distress (p < 0.001), and treatment duration ≥ 1 year (p = 0.03). Over time, rates of low adherence and high distress remained stable, but unintentional non-take decreased from 47.9% to 26.0% at week-48. MF patients with stable high adherence/low distress were more likely to obtain/maintain the spleen response at week-24. Low adherence to ruxolitinib represents an unmet clinical need that require a multifaceted approach, based on reason behind it (patients characteristics and treatment duration). Its recognition may help distinguishing patients who are truly refractory and those in need of therapy optimization.


Assuntos
Adesão à Medicação , Nitrilas , Policitemia Vera , Mielofibrose Primária , Pirazóis , Pirimidinas , Humanos , Mielofibrose Primária/tratamento farmacológico , Pirimidinas/uso terapêutico , Pirazóis/uso terapêutico , Masculino , Policitemia Vera/tratamento farmacológico , Feminino , Estudos Prospectivos , Idoso , Pessoa de Meia-Idade , Itália/epidemiologia , Adesão à Medicação/estatística & dados numéricos , Idoso de 80 Anos ou mais , Adulto
2.
ESMO Open ; 8(6): 102192, 2023 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-38052104

RESUMO

BACKGROUND: The Patient Reported Outcome for Fighting FInancial Toxicity (PROFFIT) questionnaire was developed to measure financial toxicity (FT) and identify its determinants. The aim of the present study was to confirm its validity in a prospective cohort of patients receiving anticancer treatment. PATIENTS AND METHODS: From March 2021 to July 2022, 221 patients were enrolled at 10 Italian centres. Selected items of the EORTC-QLQ-C30 questionnaire represented the anchors, specifically, question 28 (Q-28) on financial difficulties, and questions 29-30 measuring global health status/quality of life (HR-QOL). The study had 80% power to detect a 0.20 correlation coefficient (r) between anchors and PROFFIT-score (items 1-7, range 0-100, 100 indicating maximum FT) with bilateral alpha 0.05 and 80% power. Confirmatory factor analysis was conducted. FT determinants (items 8-16) were described. RESULTS: Median age of patients was 65 years, 116 (52.5%) were females, 96 (43.4%) had low education level. Confirmatory factor analysis confirmed goodness of fit of the PROFFIT-score. Significant partial correlation of PROFFIT-score was found with Q-28 (r = 0.51) and HR-QOL (r = -0.23). Mean (SD) PROFFIT-score at baseline was 36.5 (24.9); it was statistically significantly higher for patients living in South Italy, those with lower education level, those who were freelancer/unemployed at diagnosis and those who reported significant economic impact from the COVID-19 pandemic. Mean (SD) scores of determinants ranged from 17.6 (27.1) for item 14 (support from medical staff) to 49.0 (36.3) for item 10 (expenses for medicines or supplements). PROFFIT-score significantly increased with worsening response to determinants. CONCLUSIONS: External validation of PROFFIT-score in an independent sample of patients was successful. The instrument is now being used in clinical studies.


Assuntos
Neoplasias , Qualidade de Vida , Feminino , Humanos , Idoso , Masculino , Estudos Prospectivos , Estresse Financeiro , Pandemias , Neoplasias/terapia , Inquéritos e Questionários , Medidas de Resultados Relatados pelo Paciente
3.
Qual Life Res ; 29(9): 2485-2495, 2020 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-32458409

RESUMO

OBJECTIVE: To develop Austrian, Italian, and Polish general population value sets for the EORTC QLU-C10D, a cancer-specific utility instrument based on the EORTC QLQ-C30, and to descriptively compare their index scores for distinct health states. METHODS: The QLU-C10D descriptive system comprises 10 health attributes and each can take on 4 levels. A standardised and pre-tested methodology has been applied for valuations including a web-based discrete choice experiment (DCE). It was administered in 1000 general population respondents per country recruited via online panels, aiming at representativeness for core socio-demographic variables. RESULTS: In all three countries, the attributes with the largest impact on utility were physical functioning, pain, and role functioning. Cancer-specific dimensions with the largest impact were nausea and fatigue or bowel problems. Utility values of the worst health state (i.e. severe problems on all 10 dimension) were -0.111 (Austria), 0.025 (Italy), and 0.048 (Poland). Country-specific utilities differed for a selection of health states across the continuum. Austrian utilities were systematically lower for moderately and severely impaired health states. CONCLUSION: QLU-C10D cancer-specific utilities can now be calculated in three more countries. Differences between countries indicate that careful consideration is required when using non-country-specific value sets in economic evaluations.


Assuntos
Qualidade de Vida/psicologia , Adolescente , Adulto , Idoso , Idoso de 80 Anos ou mais , Áustria , Análise Custo-Benefício/métodos , Feminino , Humanos , Itália , Masculino , Pessoa de Meia-Idade , Polônia , Inquéritos e Questionários , Adulto Jovem
4.
Qual Life Res ; 29(4): 867-878, 2020 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-31776827

RESUMO

PURPOSE: The time to deterioration (TTD) approach has been proposed as a modality of longitudinal analysis of patient-reported outcomes (PROs) in cancer randomized clinical trials (RCTs). The objective of this study was to perform a systematic review of how the TTD approach has been used in phase III RCTs to analyze longitudinal PRO data. METHODS: A systematic literature search was conducted in PubMed/MEDLINE, the Cochrane Library and through manual search to identify studies published between January 2014 and June 2018. All phase III cancer RCTs including a PRO endpoint using the TTD approach were considered. We collected general information about the study, PRO assessment and the TTD approach, such as the event definition, the choice of reference score and whether the deterioration was definitive or not. RESULTS: A total of 1549 articles were screened, and 39 studies were finally identified as relevant according to predefined criteria. Among these 39 studies, 36 (92.3%) were in advanced and/or metastatic cancer. Several different deterioration definitions were used in RCTs, 10 studies (25.6%) defined the deterioration as "definitive", corresponding to a deterioration maintained over time until the last PRO assessment available for each patient. The baseline score was explicitly stated as the reference score to qualify the deterioration for most studies (n = 31, 79.5%). CONCLUSION: This review highlights the lack of standardization of the TTD approach for the analysis of PRO data in RCTs. Special attention should be paid to the definition of "deterioration", and this should be based on the specific cancer setting.


Assuntos
Deterioração Clínica , Neoplasias/patologia , Neoplasias/terapia , Medidas de Resultados Relatados pelo Paciente , Humanos , Qualidade de Vida , Ensaios Clínicos Controlados Aleatórios como Assunto
5.
Ann Hematol ; 95(2): 211-9, 2016 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-26546359

RESUMO

The primary objective of this study was to investigate whether the presence of comorbidities was associated with a lower health-related quality of life (HRQOL) in elderly patients with chronic myeloid leukemia (CML). A sample of 174 CML patients aged 60 years or above was analyzed. HRQOL was assessed with the Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36). A number of pre-selected sociodemographic and disease-related factors were considered as potential confounding factors for the association between comorbidity and HRQOL. Mean age of the 174 patients analyzed was 70 years (range 60-87 years) and 55 % were male. Overall, 111 patients (64 %) reported at least one comorbidity. Analysis stratified by age group category showed a greater proportion of patients with comorbidities in the older sub-group population (≥70 years) compared to younger patients (60 to 69 years). Differences in HRQOL outcomes between patients with no comorbidity at all and those with two or more comorbid conditions were at least twice the magnitude of a clinically meaningful difference in all the physical and mental health scales of the SF-36. In multivariate analysis, after adjusting for key confounding factors, the following scales were significantly lower in those with comorbidity: general health (p < 0.001), bodily pain (p < 0.001), physical functioning (p = 0.002), and vitality (p = 0.002). Assessing comorbidity in elderly patients with CML is important to facilitate identification of those most in need of HRQOL improvements.


Assuntos
Nível de Saúde , Inquéritos Epidemiológicos , Leucemia Mielogênica Crônica BCR-ABL Positiva/epidemiologia , Leucemia Mielogênica Crônica BCR-ABL Positiva/psicologia , Qualidade de Vida/psicologia , Idoso , Idoso de 80 Anos ou mais , Comorbidade , Estudos Transversais , Feminino , Inquéritos Epidemiológicos/métodos , Humanos , Masculino , Pessoa de Meia-Idade , Doenças Musculoesqueléticas/epidemiologia , Doenças Musculoesqueléticas/psicologia , Dor/epidemiologia , Dor/psicologia
6.
Leuk Res ; 39(8): 859-65, 2015 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-26120100

RESUMO

Higher-risk myelodysplastic syndromes (MDS) are rarely curable and have a poor prognosis. We investigated the accuracy of physicians' perception of patients' health status and the patients' preferences for involvement in treatment decisions. We examined 280 newly diagnosed higher-risk elderly MDS patients paired with their physicians. Survey tools included the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) and the Control Preference Scale. Overall concordance was 49% for physician perception of patient preferences for involvement in treatment decisions. In 36.4% of comparisons there were minor differences and in 14.6% there were major differences. In 44.7% of the patients preferring a passive role, physicians perceived them as preferring an active or collaborative role. Absence of the patient's request for prognostic information (P=0.001) and judging the patient as having a poor health status (P=0.036) were factors independently associated with the physicians' attitude toward a lower degree of patient involvement in clinical decisions. Agreement on health status was found in 27.5% of cases. Physicians most frequently tended to overestimate health status of patients who reported low-level health status. The value of decision aid-tools in the challenging setting of higher-risk MDS should be investigated to further promote patient-centered care.


Assuntos
Nível de Saúde , Síndromes Mielodisplásicas/terapia , Preferência do Paciente , Relações Médico-Paciente , Médicos , Adulto , Idoso , Idoso de 80 Anos ou mais , Tomada de Decisões , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Síndromes Mielodisplásicas/epidemiologia , Síndromes Mielodisplásicas/psicologia , Participação do Paciente/psicologia , Participação do Paciente/estatística & dados numéricos , Preferência do Paciente/estatística & dados numéricos , Percepção , Médicos/psicologia , Médicos/estatística & dados numéricos , Qualidade de Vida , Fatores de Risco , Inquéritos e Questionários
7.
Psychooncology ; 24(4): 382-94, 2015 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-25196048

RESUMO

BACKGROUND: Cancer care is increasingly provided in the outpatient setting, requiring specific monitoring of care quality. The patients' perspective is an important indicator of care quality and needs to be assessed with well designed, psychometrically sound questionnaires. We performed a systematic literature review of currently available patient satisfaction measures for use in cancer outpatient care settings. METHODS: We carried out MEDLINE/PubMed, PsycINFO, CINAHL, and Scopus searches of papers published over the past 15 years that describe cancer patient satisfaction questionnaires for use in the outpatient setting. We used the adapted COSMIN checklist to assess the quality of the questionnaires' measurement properties. RESULTS: A total of 6677 citations were identified and 76 relevant articles were read, of which 55 were found either not to be relevant or to provide insufficient psychometric information. The remaining 21 studies pertained to 14 patient satisfaction questionnaires. Continuity and transition, accessibility, and involvement of family/friends were less frequently addressed despite their relevance in outpatient oncology. Almost half of the psychometric studies did not provide information on item level missing data. Most internal consistency estimates (Cronbach's α) were satisfactory. Few studies reported test-retest assessment (n = 5), used confirmatory factor analysis (n = 2), or assessed fit to a graded response item response theory model (n = 3). Only three questionnaires were cross-culturally validated. CONCLUSION: Important aspects of care may be missed by current patient satisfaction questionnaires for use in the cancer outpatient setting. Additional evidence is needed of their psychometric performance, especially for cross-cultural comparative assessments.


Assuntos
Assistência Ambulatorial/normas , Oncologia/normas , Neoplasias/terapia , Satisfação do Paciente , Qualidade da Assistência à Saúde , Assistência à Saúde Culturalmente Competente , Humanos , Neoplasias/psicologia , Avaliação de Resultados da Assistência ao Paciente , Psicometria , Reprodutibilidade dos Testes , Inquéritos e Questionários
8.
Ann Oncol ; 25(2): 447-54, 2014 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-24478321

RESUMO

BACKGROUND: The main objective of this study was to assess preferences for involvement in treatment decisions and requests for prognostic information in newly diagnosed higher-risk myelodysplastic syndrome (MDS) patients. PATIENT AND METHODS: This was a prospective cohort observational study that consecutively enrolled MDS patients with an international prognostic scoring system (IPSS) risk category of intermediate-2 or high risk (summarized as 'higher risk'). The control preference scale was used to assess patient preferences for involvement in treatment decisions, and whether a request by patients for prognostic information during consultation was made, was also recorded. All of the patients were surveyed at the time of diagnosis before receiving treatment. Univariate and multivariate analyses were carried out to assess how sociodemographic, clinical and laboratory data related to decision-making preferences and requests for prognostic information. Relationship with the health-related quality of life (HRQOL) profile was also examined. RESULTS: A total of 280 patients were enrolled, 74% with intermediate-2 and 26% with high-risk IPSS. The mean age of patients was 70-year old (range: 32-89 years). One hundred thirty-two patients (47%) favored a passive role in treatment decision-making, whereas only 14% favored an active role. The remaining 39% of patients favored a shared decision-making approach. Patients with lower hemoglobin levels were more likely to prefer a passive role (P=0.037). HRQOL was generally better in patients preferring an active role versus those preferring a passive one. Overall, 61% (N=171) of patients requested prognostic information on survival during consultation. The likelihood of not requesting prognostic information was higher for older patients (P = 0.003) and for those with lower education (P=0.010). CONCLUSION: Decision-making preferences vary among patients with newly diagnosed higher-risk MDS. Current findings suggest that patients with worse underlying health conditions are more likely to prefer less involvement in treatment decisions.


Assuntos
Síndromes Mielodisplásicas/diagnóstico , Participação do Paciente/estatística & dados numéricos , Adulto , Idoso , Idoso de 80 Anos ou mais , Tomada de Decisões , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Síndromes Mielodisplásicas/epidemiologia , Síndromes Mielodisplásicas/terapia , Preferência do Paciente , Prevalência , Prognóstico , Estudos Prospectivos , Fatores Socioeconômicos , Resultado do Tratamento
9.
Leukemia ; 27(7): 1511-9, 2013 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-23417029

RESUMO

Health-related quality of life (HRQOL) is an important goal of therapy for chronic myeloid leukemia (CML) patients treated with current molecular-targeted therapies. The main objective of this study was to investigate factors associated with long-term HRQOL outcomes of CML patients receiving imatinib. Analysis was performed on 422 CML patients recruited in an observational multicenter study. HRQOL was assessed with the Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36). Key socio-demographic and clinical data were investigated for their association with HRQOL outcomes. Chronic fatigue and social support were also investigated. Univariate and multivariate linear regression analyses were used to identify independent factors associated with HRQOL outcomes. Fatigue was the only variable showing an independent and consistent association across all physical and mental HRQOL outcomes (P<0.01). Differences between patients reporting low versus high fatigue levels were more than eight and seven times the magnitude of a clinically meaningful difference, respectively, for the role physical (Δ=70 points) and emotional scale (Δ=63 points) of the SF-36. Fatigue did not occur as an isolated symptom and was most highly correlated with musculoskeletal pain (r=0.511; P≤0.001) and muscular cramps (r=0.448; P≤0.001). Chronic fatigue is the major factor limiting HRQOL of CML patients receiving imatinib.


Assuntos
Benzamidas/uso terapêutico , Síndrome de Fadiga Crônica/complicações , Leucemia Mielogênica Crônica BCR-ABL Positiva/complicações , Leucemia Mielogênica Crônica BCR-ABL Positiva/tratamento farmacológico , Piperazinas/uso terapêutico , Pirimidinas/uso terapêutico , Qualidade de Vida , Adulto , Idoso , Idoso de 80 Anos ou mais , Antineoplásicos/uso terapêutico , Estudos Transversais , Síndrome de Fadiga Crônica/psicologia , Feminino , Inquéritos Epidemiológicos , Humanos , Mesilato de Imatinib , Leucemia Mielogênica Crônica BCR-ABL Positiva/psicologia , Masculino , Pessoa de Meia-Idade , Análise Multivariada , Cãibra Muscular/complicações , Cãibra Muscular/psicologia , Dor Musculoesquelética/complicações , Dor Musculoesquelética/psicologia , Comportamento Social , Adulto Jovem
10.
Br J Cancer ; 107(6): 904-9, 2012 Sep 04.
Artigo em Inglês | MEDLINE | ID: mdl-22871884

RESUMO

BACKGROUND: Optimal adherence to imatinib therapy is of paramount importance to maximise treatment effectiveness in patients with chronic myeloid leukaemia (CML). The main objective of this study was to investigate patient-reported personal factors associated with adherence behaviour. METHODS: Analysis was conducted on 413 CML patients receiving long-term therapy with imatinib. Adherence behaviour was measured with the Morisky Medication Adherence Scale and personal factors investigated included: quality of life, perceived social support, fatigue, symptom burden, psychological wellbeing and desire for additional information. Key socio-demographic and treatment-related factors were also taken into account. Univariate and multivariate logistic regression analyses were used to investigate factors associated with optimal adherence to therapy. RESULTS: In all, 53% of patients reported an optimal adherence behaviour. The final multivariate model retained the following variables as independent predictors of optimal adherence to therapy: desire for more information (ref. no), odds ratio (OR)=0.43 (95% confidence interval (CI), 0.29-0.66; P<0.001), social support (higher score representing greater support), OR=1.29 (95% CI, 1.11-1.49; P<0.001) and concomitant drug burden (ref. no), OR=1.82 (95% CI, 1.18-2.80; P=0.006). CONCLUSION: This study suggests that a higher level of social support, satisfaction with information received and concomitant drug burden are the main factors associated with greater adherence to long-term imatinib therapy.


Assuntos
Antineoplásicos/administração & dosagem , Fadiga , Comportamento de Busca de Informação , Leucemia Mielogênica Crônica BCR-ABL Positiva/tratamento farmacológico , Adesão à Medicação , Piperazinas/administração & dosagem , Pirimidinas/administração & dosagem , Qualidade de Vida , Apoio Social , Adulto , Idoso , Idoso de 80 Anos ou mais , Análise de Variância , Antineoplásicos/efeitos adversos , Benzamidas , Fadiga/etiologia , Fadiga/psicologia , Feminino , Humanos , Mesilato de Imatinib , Modelos Logísticos , Masculino , Adesão à Medicação/psicologia , Adesão à Medicação/estatística & dados numéricos , Pessoa de Meia-Idade , Razão de Chances , Piperazinas/efeitos adversos , Pirimidinas/efeitos adversos , Fatores de Risco , Resultado do Tratamento
11.
Crit Rev Oncol Hematol ; 81(2): 123-35, 2012 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-21435899

RESUMO

Health-related quality of life (HRQOL) and other patient-reported outcomes (PROs) might be crucial in comparing effectiveness of treatments as they could provide invaluable information to better inform clinical decision-making. This is particularly true in the era of targeted therapies (TT). A systematic review was undertaken on all studies with CML patients published from 1980 to 2010 and including a PRO evaluation. Out of 619 articles scrutinized, 15 met eligibility criteria and no study was published before 1995. Six dealt mainly with interferon-based therapies, 7 with bone marrow transplantation and only 2 evaluated PROs in the context of TT. No disease-specific, validated PRO instrument for these patients was found. The main evidence being that Imatinib provides clear advantage in terms of HRQOL over interferon-based treatments. There is lack of data concerning PROs in patients treated with current TT. Documenting HRQOL and side effects of CML treatments, from the patients' perspective is needed to evaluate overall treatment effectiveness and net clinical benefit of newer therapeutic strategies.


Assuntos
Leucemia Mielogênica Crônica BCR-ABL Positiva/terapia , Terapia de Alvo Molecular , Qualidade de Vida , Transplante de Medula Óssea , Humanos , Fatores de Tempo , Resultado do Tratamento
12.
Eur J Surg Oncol ; 33 Suppl 2: S95-104, 2007 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-18039559

RESUMO

With the recent trend of improved survival, there has been a marked interest in reviewing and refining the contribution of health related quality of life (HRQoL) outcome measures of treatment in advanced colorectal cancer. However, if HRQoL data are going to be of clinical value and help both physicians and patients make decisions there is a need for a consensus on both the design and methods of measurement of HRQoL in clinical trials, and an acknowledgement of the interpretation of the outcomes in clinical practice. Whilst it is encouraging to find that the quality of HRQoL measurement in clinical research has improved significantly over the last fifteen years, with a growing number of trial-based HRQoL studies, there is still the potential to improve the use of HRQoL in clinical decision making in advanced colorectal cancer. There is also the need to further refine measurement of HRQoL to provide useful data specific to these patients. It is anticipated that developments such as the liver metastases module EORTC (QLQ-LMC21) questionnaire will increase the sensitivity to change of the generic cancer measure, the EORTC QLQ-C30 and will provide essential HRQoL information regarding the use of treatments in both the curative and palliative settings. Furthermore, easy to use simple tools such as the "minimum standard checklist for evaluating HRQoL outcomes in cancer clinical trials" might be of help in guiding investigators on the basis of minimum criteria.


Assuntos
Neoplasias Colorretais , Neoplasias Hepáticas , Qualidade de Vida , Antineoplásicos/efeitos adversos , Antineoplásicos/uso terapêutico , Neoplasias Colorretais/patologia , Neoplasias Colorretais/terapia , Humanos , Neoplasias Hepáticas/secundário , Neoplasias Hepáticas/terapia , Avaliação de Resultados em Cuidados de Saúde , Valor Preditivo dos Testes , Inquéritos e Questionários
13.
Br J Cancer ; 97(3): 302-7, 2007 Aug 06.
Artigo em Inglês | MEDLINE | ID: mdl-17609661

RESUMO

This is one of the few studies that have explored the value of baseline symptoms and health-related quality of life (HRQOL) in predicting survival in brain cancer patients. Baseline HRQOL scores (from the EORTC QLQ-C30 and the Brain Cancer Module (BN 20)) were examined in 490 newly diagnosed glioblastoma cancer patients for the relationship with overall survival by using Cox proportional hazards regression models. Refined techniques as the bootstrap re-sampling procedure and the computation of C-indexes and R(2)-coefficients were used to try and validate the model. Classical analysis controlled for major clinical prognostic factors selected cognitive functioning (P=0.0001), global health status (P=0.0055) and social functioning (P<0.0001) as statistically significant prognostic factors of survival. However, several issues question the validity of these findings. C-indexes and R(2)-coefficients, which are measures of the predictive ability of the models, did not exhibit major improvements when adding selected or all HRQOL scores to clinical factors. While classical techniques lead to positive results, more refined analyses suggest that baseline HRQOL scores add relatively little to clinical factors to predict survival. These results may have implications for future use of HRQOL as a prognostic factor in cancer patients.


Assuntos
Neoplasias Encefálicas/fisiopatologia , Glioblastoma/fisiopatologia , Qualidade de Vida , Análise de Sobrevida , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Prognóstico , Estudos Prospectivos
14.
Ann Oncol ; 18(4): 775-81, 2007 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-17259641

RESUMO

BACKGROUND: Previous work highlighted a number of methodological constraints when reporting health-related quality of life (HRQOL) outcomes from randomized controlled trials (RCTs). Given this, the objective of this study was to investigate whether the quality of such HRQOL reports has improved over time. MATERIALS AND METHODS: On the basis of a predefined set of criteria, 159 RCTs with a HRQOL end point, published between 1990 and 2004 were identified and analyzed. Each study was evaluated by a number of issues (e.g. sample size and industry sponsorship) and by the "minimum standard checklist for evaluating HRQOL outcomes in cancer clinical trials". RESULTS: The quality of HRQOL reports, as measured by the overall checklist score, was independently related to more recently published studies (P < 0.0001). This relationship was independent of industry funded, HRQOL end point (primary versus secondary), cancer disease site, size of the study and HRQOL difference between treatment arms. While only 39.3% of studies published between 1990 and 2000 (89/159 RCTs) were identified as being probably robust, thus likely to support clinical decision making, this percentage was 64.3% for studies published after 2000 (70/159 RCTs). CONCLUSION: Since we found a significant learning curve in HRQOL trial reporting since 1990, it can be expected that HRQOL data will increasingly impact on clinical decision making and treatment policies in the near future.


Assuntos
Tomada de Decisões , Neoplasias/psicologia , Qualidade de Vida , Nível de Saúde , Humanos , Ensaios Clínicos Controlados Aleatórios como Assunto
15.
Eur J Cancer ; 43(2): 323-30, 2007 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-17156997

RESUMO

The aim of this study was to identify factors associated significantly with hospitalised cancer patients' satisfaction with care. Patients were recruited from four geographical/cultural groups, including five European countries and Taiwan. They rated their level of satisfaction by completing the EORTC IN-PATSAT32 questionnaire at home. Additionally, data were collected on the sociodemographic and clinical characteristics and the quality of life of the patients, as well as on institutional characteristics. Of 762 patients recruited, 647 (85%) returned a completed questionnaire. The number of nurses and doctors per bed, institution size, geo-cultural origin, ward setting, teaching/non-teaching setting, treatment toxicity, global health status, participation in clinical trials and education level were all associated significantly at the multivariate level with satisfaction with doctor and nurse interpersonal skills, information provision, availability, and/or overall satisfaction. A number of patient-, institutional- and culture-related factors are associated with the perceived quality of cancer care. Future studies, with appropriate sampling frames and stratification procedures, are needed to better understand cross-national and cross-cultural differences in cancer patient satisfaction.


Assuntos
Neoplasias/psicologia , Satisfação do Paciente , Adulto , Idoso , Idoso de 80 Anos ou mais , Feminino , Humanos , Itália , Masculino , Pessoa de Meia-Idade , Neoplasias/terapia , Relações Médico-Paciente , Espanha , Inquéritos e Questionários , Taiwan
16.
Ann Oncol ; 17(11): 1698-704, 2006 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-16968876

RESUMO

BACKGROUND: The aim of this prognostic factor analysis was to investigate if a patient's self-reported health-related quality of life (HRQOL) provided independent prognostic information for survival in non-small cell lung cancer (NSCLC) patients. PATIENTS AND METHODS: Pretreatment HRQOL was measured in 391 advanced NSCLC patients using the EORTC QLQ-C30 and the EORTC Lung Cancer module (QLQ-LC13). The Cox proportional hazards regression model was used for both univariate and multivariate analyses of survival. In addition, a bootstrap validation technique was used to assess the stability of the outcomes. RESULTS: The final multivariate Cox regression model retained four parameters as independent prognostic factors for survival: male gender with a hazard ratio (HR) = 1.32 (95% CI 1.03-1.69; P = 0.03); performance status (0 to 1 versus 2) with HR = 1.63 (95% CI 1.04-2.54; P = 0.032); patient's self-reported score of pain with HR= 1.11 (95% CI 1.07-1.16; P < 0.001) and dysphagia with HR = 1.12 (95% CI 1.04-1.21; P = 0.003). A 10-point shift worse in the scale measuring pain and dysphagia translated into an 11% and 12% increased in the likelihood of death respectively. A risk group categorization was also developed. CONCLUSION: The results suggest that patients' self-reported HRQOL provide independent prognostic information for survival. This finding supports the collection of such data in routine clinical practice.


Assuntos
Carcinoma Pulmonar de Células não Pequenas/diagnóstico , Nível de Saúde , Qualidade de Vida , Adulto , Idoso , Europa (Continente) , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Análise Multivariada , Prognóstico , Análise de Regressão , Análise de Sobrevida
18.
Eur J Cancer ; 41(14): 2120-31, 2005 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-16182120

RESUMO

Little is known about patients' satisfaction with care in oncology hospitals across cultural contexts. Within the EORTC, we developed a 32-item satisfaction with care questionnaire to measure patients' appraisal of hospital doctors and nurses, as well as aspects of care organisation and services. This study assessed the psychometric characteristics of the questionnaire, the EORTC IN-PATSAT32, in a large, international sample of patients with cancer. Patients discharged from a surgery or medical oncology ward in nine countries were invited to complete at home the EORTC IN-PATSAT32 as well as other instruments for psychometric testing. Of 762 eligible patients recruited, 15% failed to return the questionnaire. Of the 647 compliant patients, 63% completed the questionnaires within 15 min and 82% required no help in its completion. Multitrait scaling analysis revealed excellent internal consistency and convergent validity, although some scales within the IN-PATSAT32 were relatively highly correlated. Test-retest data on 113 patients showed high reliability for most scales. Scales of the IN-PATSAT32 and of the QLQ-C30 were not significantly correlated, suggesting that the two questionnaires are assessing quite distinct concepts. The scales of the IN-PATSAT32 were able to discriminate clearly between patients with differing care expectations and differing intentions to recommend their hospital to others. This study supports the acceptability to patients, and the psychometric robustness of the EORTC IN-PATSAT32 questionnaire. Further studies are needed to assess the responsiveness of the questionnaire to changes in the structure and process of care over time.


Assuntos
Neoplasias/terapia , Satisfação do Paciente , Adulto , Idoso , Humanos , Pessoa de Meia-Idade , Neoplasias/psicologia , Prognóstico , Estudos Prospectivos , Psicometria , Qualidade de Vida , Inquéritos e Questionários
19.
Eur J Cancer ; 41(12): 1697-709, 2005 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-16043345

RESUMO

Over the last decade, health related quality of life (HRQOL) investigations have become an increasingly important part of many cancer clinical trial research programs. This paper presents a review of all HRQOL studies published by the European Organisation for Research and Treatment of Cancer (EORTC), one of the largest clinical trials organisations in Europe. The findings highlight 24 clinical trials that have been published to date, enrolling over 9000 patients. HRQOL is fully integrated into EORTC phase III trials. In many trials, HRQOL provides a valuable source of additional information useful to both clinician and patient when making treatment decisions. Furthermore, several trials have found that the combined use of clinical information along with HRQOL data has led to the development of new standards of care in several different cancer sites. With more than 40 ongoing HRQOL studies in the EORTC, we expect HRQOL to play an even greater role over the coming decade in helping establish the optimal treatment and care approach for cancer patients.


Assuntos
Ensaios Clínicos como Assunto/estatística & dados numéricos , Nível de Saúde , Neoplasias/terapia , Qualidade de Vida , Humanos
20.
Eur J Cancer Care (Engl) ; 14(1): 28-42, 2005 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-15698384

RESUMO

The aim of this study was to investigate the consensus of skin care advice given by nurses during radiotherapy. Sixty-seven nurses, identified through nine Belgian radiotherapy departments, responded to a questionnaire survey consisting of 58 items regarding prevention and management of erythema, dry desquamation and moist desquamation. Consensus for a given advice was categorized as small if less than 50% of the nurses gave the same answer, as moderate if between 50% and 75% and as large when more than 75%. Overall, 33% of the items showed small consensus, 29% showed moderate consensus and 38% showed large consensus. The highest consensus was seen for advice in cases of moist and dry desquamation. There was less agreement in the case of erythema and it decreased further for preventive advice. Some skin care techniques that were frequently used by the nurses cannot be supported by the literature. Also, some techniques recommended by the literature are not frequently used. Further, few differences (P < 0.05) between nurses working in a university hospital and the ones working in a non-university hospital were found in terms of advice given to patients. To increase consensus on skin care issues more conclusive research is needed. Of equal importance is the translation of existing research results into daily clinical practice.


Assuntos
Radiodermite/enfermagem , Radioterapia/efeitos adversos , Adulto , Eritema/etiologia , Eritema/enfermagem , Eritema/prevenção & controle , Feminino , Humanos , Masculino , Guias de Prática Clínica como Assunto , Radiodermite/prevenção & controle , Higiene da Pele/métodos , Inquéritos e Questionários
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