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1.
Lancet Oncol ; 25(9): 1202-1212, 2024 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-39146951

RESUMO

BACKGROUND: In the European Organisation for Research and Treatment of Cancer (EORTC) 1325-MG/KEYNOTE-054 study, adjuvant pembrolizumab improved recurrence-free survival and distant-metastasis-free survival in patients with resected stage III melanoma. Earlier results showed no effect of pembrolizumab on health-related quality of life (HRQOL). Little is known about HRQOL after completion of treatment with pembrolizumab, an important research area concerning patients who are likely to become long-term survivors. This study reports long-term HRQOL results. METHODS: This double-blind, randomised, controlled, phase 3 trial compared adjuvant pembrolizumab with placebo in patients aged 18 years or older with previously untreated stage IIIA, IIIB, or IIIC resected cutaneous melanoma and an Eastern Cooperative Oncology Group performance status score of 1 or 0, recruited from 123 academic centres and community hospitals in 23 countries. Patients were randomly assigned (1:1) with a minimisation technique stratified for stage and geographical region to receive 200 mg of intravenous pembrolizumab or placebo every 3 weeks for up to 18 doses. Investigators, patients, and those collecting or analysing data were masked to group assignment. The primary endpoint of the trial was recurrence-free survival (reported elsewhere). HRQOL was a prespecified exploratory endpoint, measured with the EORTC Quality of Life Questionnaire-Core 30. All patients with a baseline HRQOL evaluation available who were alive 108 weeks from randomisation were included in this analysis of long-term HRQOL. Long-term HRQOL included assessments measured every 6 months between 108 weeks and 48 months after randomisation. The threshold of clinical relevance for all HRQOL scales used was an average change of 5 points. The trial is ongoing, recruitment is completed, and HRQOL data collection is finalised. This study is registered with ClinicalTrials.gov, NCT02362594, and EudraCT, 2014-004944-37. FINDINGS: Between Aug 26, 2015, and Nov 14, 2016, 1019 patients were randomly assigned to pembrolizumab (n=514) or placebo (n=505). Completion of the HRQOL evaluation at baseline exceeded 90% (481 [94%] patients in the pembrolizumab group and 467 [92%] in the placebo group), and ranged between 60% and 90% for post-baseline timepoints. Among patients with a baseline HRQOL evaluation, 365 (39%) were female and 583 (61%) were male. The mean change from baseline to long-term HRQOL was -0·56 (95% CI -2·33 to 1·22) in the pembrolizumab group and 1·63 (-0·12 to 3·38) in the placebo group. The difference between the two groups was -2·19 (-4·65 to 0·27, p=0·081). Differences for all other scales were smaller than 5 and not statistically significant. INTERPRETATION: Adjuvant pembrolizumab did not have a significant impact on long-term HRQOL compared with placebo in patients with resected stage III melanoma. These findings, together with earlier results on efficacy and HRQOL, support the use of pembrolizumab in this setting. FUNDING: Merck Sharp & Dohme.


Assuntos
Anticorpos Monoclonais Humanizados , Melanoma , Estadiamento de Neoplasias , Qualidade de Vida , Neoplasias Cutâneas , Humanos , Anticorpos Monoclonais Humanizados/uso terapêutico , Anticorpos Monoclonais Humanizados/efeitos adversos , Melanoma/tratamento farmacológico , Melanoma/patologia , Melanoma/cirurgia , Feminino , Masculino , Método Duplo-Cego , Pessoa de Meia-Idade , Idoso , Neoplasias Cutâneas/tratamento farmacológico , Neoplasias Cutâneas/patologia , Neoplasias Cutâneas/cirurgia , Neoplasias Cutâneas/mortalidade , Quimioterapia Adjuvante , Antineoplásicos Imunológicos/uso terapêutico , Antineoplásicos Imunológicos/efeitos adversos , Adulto , Fatores de Tempo
2.
Lancet Oncol ; 24(2): e86-e95, 2023 02.
Artigo em Inglês | MEDLINE | ID: mdl-36725153

RESUMO

The use of item libraries for patient-reported outcome (PRO) measurement in oncology allows for the customisation of PRO assessment to measure key health-related quality of life concepts of relevance to the target population and intervention. However, no high-level recommendations exist to guide users on the design and implementation of these customised PRO measures (item lists) across different PRO measurement systems. To address this issue, a working group was set up, including international stakeholders (academic, independent, industry, health technology assessment, regulatory, and patient advocacy), with the goal of creating recommendations for the use of item libraries in oncology trials. A scoping review was carried out to identify relevant publications and highlight any gaps. Stakeholders commented on the available guidance for each research question, proposed recommendations on how to address gaps in the literature, and came to an agreement using discussion-based methods. Nine primary research questions were identified that formed the scope and structure of the recommendations on how to select items and implement item lists created from item libraries. These recommendations address methods to drive item selection, plan the structure and analysis of item lists, and facilitate their use in conjunction with other measures. The findings resulted in high-level, instrument-agnostic recommendations on the use of item-library-derived item lists in oncology trials.


Assuntos
Neoplasias , Qualidade de Vida , Humanos , Neoplasias/terapia , Medidas de Resultados Relatados pelo Paciente , Oncologia , Avaliação de Resultados da Assistência ao Paciente
3.
Lancet Oncol ; 24(6): e270-e283, 2023 06.
Artigo em Inglês | MEDLINE | ID: mdl-37269858

RESUMO

Patient-reported outcomes (PROs), such as symptoms, functioning, and other health-related quality-of-life concepts are gaining a more prominent role in the benefit-risk assessment of cancer therapies. However, varying ways of analysing, presenting, and interpreting PRO data could lead to erroneous and inconsistent decisions on the part of stakeholders, adversely affecting patient care and outcomes. The Setting International Standards in Analyzing Patient-Reported Outcomes and Quality of Life Endpoints in Cancer Clinical Trials-Innovative Medicines Initiative (SISAQOL-IMI) Consortium builds on the existing SISAQOL work to establish recommendations on design, analysis, presentation, and interpretation for PRO data in cancer clinical trials, with an expanded set of topics, including more in-depth recommendations for randomised controlled trials and single-arm studies, and for defining clinically meaningful change. This Policy Review presents international stakeholder views on the need for SISAQOL-IMI, the agreed on and prioritised set of PRO objectives, and a roadmap to ensure that international consensus recommendations are achieved.


Assuntos
Neoplasias , Qualidade de Vida , Humanos , Medidas de Resultados Relatados pelo Paciente , Neoplasias/tratamento farmacológico , Consenso
4.
Qual Life Res ; 32(2): 447-459, 2023 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-36273365

RESUMO

PURPOSE: To develop and validate a health-related quality of life (HRQoL) questionnaire for patients with current or previous coronavirus disease (COVID-19) in an international setting. METHODS: This multicenter international methodology study followed standardized guidelines for a four-phase questionnaire development. Here, we report on the pretesting and validation of our international questionnaire. Adults with current or previous COVID-19, in institutions or at home were eligible. In the pretesting, 54 participants completed the questionnaire followed by interviews to identify administration problems and evaluate content validity. Thereafter, 371 participants completed the revised questionnaire and a debriefing form to allow preliminary psychometric analysis. Validity and reliability were assessed (correlation-based methods, Cronbach's α, and intra-class correlation coefficient). RESULTS: Eleven countries within and outside Europe enrolled patients. From the pretesting, 71 of the 80 original items fulfilled the criteria for item-retention. Most participants (80%) completed the revised 71-item questionnaire within 15 min, on paper (n = 175) or digitally (n = 196). The final questionnaire included 61 items that fulfilled criteria for item retention or were important to subgroups. Item-scale correlations were > 0.7 for all but nine items. Internal consistency (range 0.68-0.92) and test-retest results (all but one scale > 0.7) were acceptable. The instrument consists of 15 multi-item scales and six single items. CONCLUSION: The Oslo COVID-19 QLQ-W61© is an international, stand-alone, multidimensional HRQoL questionnaire that can assess the symptoms, functioning, and overall quality of life in COVID-19 patients. It is available for use in research and clinical practice. Further psychometric validation in larger patient samples will be performed.


Assuntos
COVID-19 , Qualidade de Vida , Adulto , Humanos , Qualidade de Vida/psicologia , Estudos Prospectivos , Reprodutibilidade dos Testes , COVID-19/epidemiologia , Inquéritos e Questionários , Psicometria
5.
Psychooncology ; 31(12): 2159-2168, 2022 12.
Artigo em Inglês | MEDLINE | ID: mdl-36307941

RESUMO

OBJECTIVE: Improved treatment landscape has led to better outcomes for paediatric acute lymphoblastic leukemia (ALL) survivors. As the number of survivors increase, we need to elucidate the long-term quality of life (QoL) and domains of complaints in these patients. Furthermore, the main priorities of these patients need to be clarified. We assessed long-term QoL outcomes of survivors of childhood ALL compared to matched population controls. METHODS: QoL data were collected from survivors recruited in France and Belgium between 2012 and 2017, including the Short Form Health Survey (SF-12) and the Quality of Life Systemic Inventory (QLSI). The Wilcoxon test was used to compare SF-12 scale scores between survivors and matched population controls. For the QLSI, comparisons were mainly descriptive. RESULTS: One hundred and eighty-six survivors (mean age: 27.6 years; range: 18.1-52.8) at follow-up completed QoL measures, amongst whom 180 were matched to controls. Overall, survivors had higher QoL on all SF12 scale scores, indicating that they had better functioning compared to controls. Statistically significant differences on the SF12 were observed for Vitality, Social Functioning, Role Limitations due to Emotional Problems and Mental Health scales. QLSI outcomes suggested that survivors were happier than controls with Couple and Social Relations. Controls were unhappiest compared to survivors with Money, Love life, Self-esteem, Nutrition and Paid Work. CONCLUSIONS: Our findings suggest that survivors of childhood ALL have better QoL outcomes on some domains compared to the general population, specifically around social and emotional functioning, and that they tend to prioritize their relationships more. Interventions for improving QoL outcomes, might build on existing positive experiences with family, friends and partners.


Assuntos
Leucemia-Linfoma Linfoblástico de Células Precursoras , Qualidade de Vida , Criança , Humanos , Adulto , Sobreviventes/psicologia , Leucemia-Linfoma Linfoblástico de Células Precursoras/terapia , Leucemia-Linfoma Linfoblástico de Células Precursoras/psicologia , Saúde Mental , Autoimagem
6.
Qual Life Res ; 31(3): 877-888, 2022 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-34286416

RESUMO

PURPOSE: The European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life-Core Questionnaire (QLQ-C30) is a widely used generic self-report measure of health-related quality of life (HRQOL) for cancer patients. However, no validated voice script for interviewer-led telephone administration was previously available. The aim of this study was to develop a voice script for interviewer administration via telephone. METHODS: Following guidelines from the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) PRO Mixed Modes Good Research Practices Task Force, a randomised cross-over equivalence study, including cognitive debriefing, was conducted to assess equivalence between paper and telephone administration modes. Assuming an expected intraclass correlation coefficient (ICC) of 0.70 and a minimally acceptable level of 0.50, a sample size of 63 was required. RESULTS: Cognitive interviews with five cancer patients found the voice script to be clear and understandable. Due to a protocol deviation in the first wave of testing, only 26 patients were available for analyses. A second wave of recruitment was conducted, adding 37 patients (n = 63; mean age 55.48; 65.1% female). Total ICCs for mode comparison ranged from 0.72 (nausea and vomiting, 95% CI 0.48-0.86) to 0.90 (global health status/QoL, 95% CI 0.80-0.95; pain, 95% CI 0.79-0.95; constipation, 95% CI 0.80-0.95). For paper first administration, all ICCs were above 0.70, except nausea and vomiting (ICC 0.55; 95% CI 0.24-0.76) and financial difficulties (ICC 0.60; 95% CI 0.31-0.79). For phone first administration, all ICCs were above 0.70. CONCLUSIONS: The equivalence testing results support the voice script's validity for administration of the QLQ-C30 via telephone.


Assuntos
Neoplasias , Qualidade de Vida , Feminino , Nível de Saúde , Humanos , Masculino , Pessoa de Meia-Idade , Neoplasias/psicologia , Qualidade de Vida/psicologia , Inquéritos e Questionários , Telefone
7.
Eur J Haematol ; 106(5): 697-707, 2021 May.
Artigo em Inglês | MEDLINE | ID: mdl-33570765

RESUMO

OBJECTIVES: To provide reference values for the European Organisation for Treatment and Research of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30) in advanced-stage Hodgkin lymphoma (HL) patients and 5-year HL survivors. The QLQ-C30 is the most widely used cancer-specific questionnaire to assess Health-Related Quality of Life (HRQoL). METHODS: The EORTC database was searched to identify HL RCTs in which patients' and survivors' HRQoL was assessed by the QLQ-C30. HRQoL mean scores were calculated and stratified by age and gender. Minimal important differences were used to assess the clinical relevance of the findings. Data from one RCT with HRQoL scores available at baseline (n = 343) and four RCTs with HRQoL scores available at follow-up (n = 1665) were analyzed. RESULTS: Patients reported worse HRQoL scores than survivors across most functioning scales and symptoms' scales. These scores varied as a function of gender but not age. Survivors' HRQoL reports were comparable to the ones of the general population. CONCLUSIONS: These values provide an assessment framework for the comparison and interpretation of QLQ-C30 scores in advanced-stage HL. Our findings suggest that although HL patients' HRQoL scores are worse than the general population, HRQoL scores may normalize over long-term survival.


Assuntos
Sobreviventes de Câncer , Doença de Hodgkin/epidemiologia , Qualidade de Vida , Fatores Etários , Sobreviventes de Câncer/estatística & dados numéricos , Bases de Dados Factuais , Europa (Continente)/epidemiologia , Feminino , Doença de Hodgkin/patologia , Doença de Hodgkin/terapia , Humanos , Masculino , Vigilância em Saúde Pública , Fatores Sexuais , Inquéritos e Questionários
8.
Qual Life Res ; 30(12): 3367-3381, 2021 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-34146226

RESUMO

PURPOSE: This systematic review was performed to identify all relevant health-related quality of life (HRQoL) issues associated with COVID-19. METHODS: A systematic literature search was undertaken in April 2020. In four teams of three reviewers each, all abstracts were independently reviewed for inclusion by two reviewers. Using a pre-defined checklist of 93 criteria for each publication, data extraction was performed independently by two reviewers and subsequently compared and discussed. If necessary, a third reviewer resolved any discrepancies. The search was updated in February 2021 to retrieve new publications on HRQoL issues including issues related to the long-term consequences of COVID-19. RESULTS: The search in April 2020 identified 3342 potentially relevant publications, and 339 publications were selected for full-text review and data extraction. We identified 75 distinct symptoms and other HRQoL issues categorized into 12 thematic areas; from general symptoms such as fever, myalgia, and fatigue, to neurological and psychological issues. The updated search revealed three extra issues experienced during active disease and long-term problems with fatigue, psychological issues and impaired cognitive function. CONCLUSION: This first comprehensive systematic review provides a detailed overview of the wide range of HRQoL issues experienced by patients with COVID-19 throughout the course of the disease. It demonstrates the devastating impact of the disease and provides critically important information for clinicians, to enable them to better recognize the disease and to provide knowledge important for treatment and follow-up. The results provided the foundation for the international development of a COVID-19 specific patient-reported HRQoL questionnaire.


Assuntos
COVID-19/psicologia , Qualidade de Vida/psicologia , COVID-19/epidemiologia , Fadiga , Humanos , Pandemias , Medidas de Resultados Relatados pelo Paciente , SARS-CoV-2 , Inquéritos e Questionários
9.
Lancet Oncol ; 21(10): e488-e494, 2020 10.
Artigo em Inglês | MEDLINE | ID: mdl-33002444

RESUMO

Patient-reported outcome (PRO) measures describe how a patient feels or functions and are increasingly being used in benefit-risk assessments in the development of cancer drugs. However, PRO research objectives are often ill-defined in clinical cancer trials, which can lead to misleading conclusions about patient experiences. The estimand framework is a structured approach to aligning a clinical trial objective with the study design, including endpoints and analysis. The estimand framework uses a multidisciplinary approach and can improve design, analysis, and interpretation of PRO results. On the basis of the International Council for Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use E9(R1) addendum, we provide an overview of the estimand framework intended for a multistakeholder audience. We apply the estimand framework to a hypothetical trial for breast cancer, using physical function to develop specific PRO research objectives. This Policy Review is not an endorsement of a specific study design or outcome; rather, it is meant to show the application of principles of the estimand framework to research study design and add to ongoing discussion. Use of the estimand framework to review medical products and label PROs in oncology can improve communication between stakeholders and ultimately provide a clearer interpretation of patient experience in the development of oncological drugs.


Assuntos
Protocolos de Ensaio Clínico como Assunto , Oncologia/normas , Medidas de Resultados Relatados pelo Paciente , Antineoplásicos/uso terapêutico , Interpretação Estatística de Dados , Desenvolvimento de Medicamentos/legislação & jurisprudência , Desenvolvimento de Medicamentos/normas , Humanos , Comunicação Interdisciplinar , Oncologia/estatística & dados numéricos , Neoplasias/tratamento farmacológico , Projetos de Pesquisa/normas
10.
Lancet Oncol ; 21(2): e83-e96, 2020 02.
Artigo em Inglês | MEDLINE | ID: mdl-32007209

RESUMO

Patient-reported outcomes (PROs), such as symptoms, function, and other health-related quality-of-life aspects, are increasingly evaluated in cancer randomised controlled trials (RCTs) to provide information about treatment risks, benefits, and tolerability. However, expert opinion and critical review of the literature showed no consensus on optimal methods of PRO analysis in cancer RCTs, hindering interpretation of results. The Setting International Standards in Analyzing Patient-Reported Outcomes and Quality of Life Endpoints Data Consortium was formed to establish PRO analysis recommendations. Four issues were prioritised: developing a taxonomy of research objectives that can be matched with appropriate statistical methods, identifying appropriate statistical methods for PRO analysis, standardising statistical terminology related to missing data, and determining appropriate ways to manage missing data. This Policy Review presents recommendations for PRO analysis developed through critical literature reviews and a structured collaborative process with diverse international stakeholders, which provides a foundation for endorsement; ongoing developments of these recommendations are also discussed.


Assuntos
Neoplasias/terapia , Medidas de Resultados Relatados pelo Paciente , Qualidade de Vida , Ensaios Clínicos Controlados Aleatórios como Assunto/normas , Projetos de Pesquisa/normas , Consenso , Humanos
11.
Jpn J Clin Oncol ; 50(11): 1333-1341, 2020 Oct 22.
Artigo em Inglês | MEDLINE | ID: mdl-32783053

RESUMO

This report summarizes the presentations and discussion in the first Japan Clinical Oncology Group-European Organisation for Research and Treatment of Cancer Quality of Life/Patient-Reported Outcome workshop funded by the National Cancer Center Hospital that was held on Saturday, 1 September 2018 in Tokyo, Japan. The infrastructure and understanding regarding the Quality of Life/Patient-Reported Outcome assessment of cancer patients in Japan is still immature, in spite of the increased demand for oncological Patient-Reported Outcome research felt not only by researchers but also by patients or other stakeholders of cancer drug development. The workshop aimed to share each perspective, common issues to be considered and future perspectives regarding the strong alliance between the European Organisation for Research and Treatment of Cancer Quality of Life Group and the Japan Clinical Oncology Group for Quality of Life/Patient-Reported Outcome research as well as explore the possibility of conducting collaborative research. European Organisation for Research and Treatment of Cancer is a leading international cancer clinical trials organization, and its Quality of Life Group is a global leader in the implementation of Quality of Life research in cancer patients. The three invited speakers from the European Organisation for Research and Treatment of Cancer Quality of Life Group presented their perspective, latest methodology and ongoing projects. The three speakers from the Japan Clinical Oncology Group presented their current status, experience and some issues regarding data management or interpretation of the Patient-Reported Outcome data. The two patient advocates also shared their expectations in terms of advances in cancer research based on the Patient-Reported Outcome assessment. As the next steps after this workshop, the Japan Clinical Oncology Group and European Organisation for Research and Treatment of Cancer have decided to cooperate more closely to facilitate Patient-Reported Outcome research in both the groups, and the Japan Clinical Oncology Group has approved the establishment of a new committee for Quality of Life/Patient-Reported Outcome research in Japan.


Assuntos
Congressos como Assunto , Oncologia , Neoplasias/terapia , Qualidade de Vida , Determinação de Ponto Final , Europa (Continente) , Feminino , Humanos , Japão , Padrões de Prática Médica , Ensaios Clínicos Controlados Aleatórios como Assunto
12.
Lancet Oncol ; 20(12): e685-e698, 2019 12.
Artigo em Inglês | MEDLINE | ID: mdl-31797795

RESUMO

A previous review published in 2008 highlighted the prognostic significance of baseline patient-reported outcomes (PROs) as independent predictors of the overall survival of patients with cancer in clinical studies. In response to the methodological limitations of studies included in the previous review, recommendations were subsequently published in the same year to promote a higher level of methodological rigour in studies of prognostic factors. Our systematic review aimed to provide an update on progress with the implementation of these recommendations and to assess whether the methodological quality of prognostic factor analyses has changed over time. Of the 44 studies published between 2006 and 2018 that were included in our review, more standardisation and rigour of the methods used for prognostic factor analysis was found compared with the previous review. 41 (93%) of the trials reported at least one PRO domain as independently prognostic. The most common significant prognostic factors reported were physical functioning (17 [39%] studies) and global health or quality of life (15 [34%] studies). These findings highlight the value of PROs as prognostic or stratification factors in research across most types of cancer.


Assuntos
Neoplasias/terapia , Medidas de Resultados Relatados pelo Paciente , Qualidade de Vida , Humanos , Agências Internacionais , Participação do Paciente , Prognóstico , Ensaios Clínicos Controlados Aleatórios como Assunto
13.
Lancet Oncol ; 19(9): e459-e469, 2018 09.
Artigo em Inglês | MEDLINE | ID: mdl-30191850

RESUMO

Although patient-reported outcomes (PROs), such as health-related quality of life, are important endpoints in randomised controlled trials (RCTs), there is little consensus about the analysis, interpretation, and reporting of these data. We did a systematic review to assess the variability, quality, and standards of PRO data analyses in advanced breast cancer RCTs. We searched PubMed for English language articles published in peer-reviewed journals between Jan 1, 2001, and Oct 30, 2017. Eligible articles were those that reported PRO results from RCTs of adult patients with advanced breast cancer receiving anti-cancer treatments with reported sample sizes of at least 50 patients-66 RCTs met the selection criteria. Only eight (12%) RCTs reported a specific PRO research hypothesis. Heterogeneity in the statistical methods used to assess PRO data was observed, with a mixture of longitudinal and cross-sectional techniques. Not all articles addressed the problem of multiple testing. Fewer than half of RCTs (28 [42%]) reported the clinical significance of their findings. 48 (73%) did not report how missing data were handled. Our systematic review shows a need to improve standards in the analysis, interpretation, and reporting of PRO data in cancer RCTs. Lack of standardisation makes it difficult to draw robust conclusions and compare findings across trials. The Setting International Standards in the Analyzing Patient-Reported Outcomes and Quality of Life Data Consortium was set up to address this need and develop recommendations on the analysis of PRO data in RCTs.


Assuntos
Neoplasias da Mama/terapia , Medidas de Resultados Relatados pelo Paciente , Ensaios Clínicos Controlados Aleatórios como Assunto/estatística & dados numéricos , Projetos de Pesquisa/estatística & dados numéricos , Neoplasias da Mama/patologia , Confiabilidade dos Dados , Interpretação Estatística de Dados , Feminino , Humanos , Modelos Estatísticos , Metástase Neoplásica , Resultado do Tratamento
14.
Clin Trials ; 15(6): 624-630, 2018 12.
Artigo em Inglês | MEDLINE | ID: mdl-30141714

RESUMO

BACKGROUND: There is currently a lack of consensus on how health-related quality of life and other patient-reported outcome measures in cancer randomized clinical trials are analyzed and interpreted. This makes it difficult to compare results across randomized controlled trials (RCTs) synthesize scientific research, and use that evidence to inform product labeling, clinical guidelines, and health policy. The Setting International Standards in Analyzing Patient-Reported Outcomes and Quality of Life Endpoints Data for Cancer Clinical Trials (SISAQOL) Consortium aims to develop guidelines and recommendations to standardize analyses of patient-reported outcome data in cancer RCTs. METHODS AND RESULTS: Members from the SISAQOL Consortium met in January 2017 to discuss relevant issues. Data from systematic reviews of the current state of published research in patient-reported outcomes in cancer RCTs indicated a lack of clear reporting of research hypothesis and analytic strategies, and inconsistency in definitions of terms, including "missing data,""health-related quality of life," and "patient-reported outcome." Based on the meeting proceedings, the Consortium will focus on three key priorities in the coming year: developing a taxonomy of research objectives, identifying appropriate statistical methods to analyze patient-reported outcome data, and determining best practices to evaluate and deal with missing data. CONCLUSION: The quality of the Consortium guidelines and recommendations are informed and enhanced by the broad Consortium membership which includes regulators, patients, clinicians, and academics.


Assuntos
Medidas de Resultados Relatados pelo Paciente , Qualidade de Vida , Ensaios Clínicos Controlados Aleatórios como Assunto , Conferências de Consenso como Assunto , Humanos , Neoplasias/terapia , Guias de Prática Clínica como Assunto , Projetos de Pesquisa/normas
16.
Cogn Emot ; 31(2): 261-268, 2017 02.
Artigo em Inglês | MEDLINE | ID: mdl-26513588

RESUMO

Social norms and values may be important predictors of how people engage with and regulate their negative emotional experiences. Previous research has shown that social expectancies (the perceived social pressure not to feel negative emotion (NE)) exacerbate feelings of sadness. In the current research, we examined whether social expectancies may be linked to how people process emotional information. Using a modified classical flanker task involving emotional rather than non-emotional stimuli, we found that, for those who experienced low levels of NE, social expectancies were linked to the selective avoidance of negative emotional information. Those who experienced high levels of NE did not show a selective avoidance of negative emotional information. The findings suggest that, for people who experience many NEs, social expectancies may lead to discrepancies between how they think they ought to feel and the kind of emotional information they pay attention to.


Assuntos
Atenção , Emoções , Percepção Social , Adolescente , Feminino , Humanos , Masculino , Adulto Jovem
17.
Lancet Oncol ; 17(11): e510-e514, 2016 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-27769798

RESUMO

Measures of health-related quality of life (HRQOL) and other patient-reported outcomes generate important data in cancer randomised trials to assist in assessing the risks and benefits of cancer therapies and fostering patient-centred cancer care. However, the various ways these measures are analysed and interpreted make it difficult to compare results across trials, and hinders the application of research findings to inform publications, product labelling, clinical guidelines, and health policy. To address these problems, the Setting International Standards in Analyzing Patient-Reported Outcomes and Quality of Life Endpoints Data (SISAQOL) initiative has been established. This consortium, directed by the European Organisation for Research and Treatment of Cancer (EORTC), was convened to provide recommendations on how to standardise the analysis of HRQOL and other patient-reported outcomes data in cancer randomised trials. This Personal View discusses the reasons why this project was initiated, the rationale for the planned work, and the expected benefits to cancer research, patient and provider decision making, care delivery, and policy making.


Assuntos
Ensaios Clínicos como Assunto , Neoplasias/terapia , Medidas de Resultados Relatados pelo Paciente , Qualidade de Vida , Humanos , Neoplasias/psicologia
18.
Cogn Emot ; 28(7): 1196-213, 2014.
Artigo em Inglês | MEDLINE | ID: mdl-24410047

RESUMO

Previous research has shown that individual differences in negative emotion differentiation may play a prominent role in well-being. Yet, many basic questions about negative emotion differentiation remain unanswered, including how it relates and overlaps with related and known dimensions of individual differences and what its possible underlying processes are. To answer these questions, in the current article we present three correlational studies that chart the nomological network of individual differences in negative emotion differentiation in terms of personality, difficulties in identifying and describing feelings, and several indicators of well-being, propose a novel paradigm to assess it in the lab, and explore relationships with a possible underlying mechanism in terms of the motivation to approach or avoid emotions. The results affirm consistent relations between negative emotion differentiation and indicators of adjustment like negative affect, self-esteem, neuroticism, depression and meta-knowledge about one's emotions, and show how it is related to the motivation to experience affective states.


Assuntos
Adaptação Psicológica , Emoções , Personalidade , Reconhecimento Psicológico , Sintomas Afetivos/psicologia , Depressão/psicologia , Feminino , Humanos , Individualidade , Masculino , Prontuários Médicos , Motivação , Inventário de Personalidade , Autoimagem , Adulto Jovem
19.
BMJ Open ; 14(9): e084935, 2024 Sep 10.
Artigo em Inglês | MEDLINE | ID: mdl-39260865

RESUMO

BACKGROUND: There are different modes and ways to assess patient-reported outcomes (PROs) in clinical trials. However, there is little systematic information on how often different modes of assessment (MOA) are used in cancer clinical trials and how exactly assessments are conducted. The goal of this scoping review is to gain an understanding of the MOA and data management of PROs in cancer randomised controlled trials (RCTs) and the reporting quality thereof. METHODS AND ANALYSIS: This scoping review protocol follows the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. Relevant trials will be identified via their indexed publications. We will search PubMed for RCTs conducted in cancer populations that evaluate a biomedical treatment with a PRO endpoint. Trials with publications published between January 2019 and November 2023 will be included. Two independent reviewers will review the references for both the abstract and full-text screening. We will extract data from the publications from a trial and the trial protocol if a protocol can be traced. Data will be summarised at the trial level. We will focus on a descriptive analysis of the MOA of PROs and on the relative frequencies of the different MOA. We will also evaluate the quality of reporting for the relevant SPIRIT and CONSORT guidelines that refer to the assessment of PROs in trials. Due to the scoping nature of our review, we will not perform a dedicated quality assessment of all trials. ETHICS AND DISSEMINATION: The proposed review is based on secondary, published data. Hence, no ethics review is necessary. The review is part of an ongoing project on the use of electronic data capture methods in cancer clinical trials. The findings from the review will support the project and contribute to synthesising guidance to ultimately improve the (electronic) measurement of patient-reported outcome measures in clinical trials.


Assuntos
Neoplasias , Medidas de Resultados Relatados pelo Paciente , Ensaios Clínicos Controlados Aleatórios como Assunto , Humanos , Neoplasias/terapia , Coleta de Dados/métodos , Projetos de Pesquisa
20.
Cogn Emot ; 27(3): 492-501, 2013.
Artigo em Inglês | MEDLINE | ID: mdl-22966838

RESUMO

Research has shown that cognitive control processes play a central role in emotion regulation. While most research has examined whether individual differences in such processes are related to the use of these strategies, a crucial next step involves examining whether such differences influence their impact on people's feelings, especially in normal daily life. The present study examined whether impairments in cognitive control (measured using an affective interference resolution task) moderate the impact of using rumination and reappraisal on affective experiences in everyday life (assessed using experience sampling methods). Multilevel analyses revealed that difficulties removing previously relevant negative information from working memory were associated with a larger increase in negative affect following rumination, and smaller increase and decrease in positive and negative affect, respectively, following reappraisal. These findings show that impaired interference resolution for negative information aggravates the deleterious effects of rumination and curbs the benefits of reappraisal in daily life.


Assuntos
Afeto , Cognição , Inibição Psicológica , Pensamento , Adulto , Feminino , Humanos , Individualidade , Masculino , Memória de Curto Prazo , Análise Multinível , Desempenho Psicomotor
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