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1.
Psychooncology ; 32(4): 628-639, 2023 04.
Artigo em Inglês | MEDLINE | ID: mdl-36707461

RESUMO

BACKGROUND: Cancer and its treatment can have substantial impact on patients' emotional functioning. Several patient-reported outcome measures (PROMs) assessing emotional functioning are available, but differences in content limit the comparability of results. To better understand conceptual (dis)similarities, we conducted a content comparison of commonly used PROMs. METHODS: We included emotional functioning items, scales, and item banks from the EORTC CAT Core, EORTC QLQ-C30, FACT-G, Hospital anxiety and depression scale (HADS), SF-36, PRO-CTCAE, and PROMIS (item banks for anxiety, depression, and anger). Item content was linked to the International Classification of Functioning, Disability, and Health (ICF) and a hierarchical framework established for PROMIS. Single items could be coded with more than one ICF category but were solely assigned to one facet within the PROMIS framework. RESULTS: The measures comprise 132 unique items covering the ICF components 'Body functions' (136/153 codings, 88.9%) and 'Activities and participation' (15/153, 9.8%). Most ICF codings (112/153, 73.2%) referred to the third-level category 'b1528 Emotional functions, other specified'. According to the PROMIS framework 48.5% of the items assessed depression (64/132 items), followed by anxiety (41/132, 31.1%) and anger (26/132, 19.7%). The EORTC measures covered depression, anxiety, and anger in a single measure, while the PROMIS inventory provides separate item banks for these concepts. The FACT-G, SF-36, PRO-CTCAE and HADS covered depression and anxiety, but not anger. CONCLUSION: Our results provide an in-depth conceptual understanding of selected PROMs and important qualitative information going beyond psychometric evidence. Such information supports the identification of PROMs for which scores can be meaningfully linked with quantitative methods.


Assuntos
Neoplasias , Qualidade de Vida , Humanos , Qualidade de Vida/psicologia , Emoções , Ansiedade , Medidas de Resultados Relatados pelo Paciente , Neoplasias/terapia , Neoplasias/psicologia , Psicometria , Inquéritos e Questionários
2.
Psychooncology ; 32(9): 1372-1384, 2023 09.
Artigo em Inglês | MEDLINE | ID: mdl-37491796

RESUMO

OBJECTIVES: In line with the World Health Organizations' health definition, patient-reported outcome (PRO) measures frequently cover aspects of social health. Our study aimed to evaluate the role functioning (RF) and social functioning (SF) contents assessed by PRO measures commonly used in cancer patients. METHODS: We analysed the item content of the SF and RF domains of the EORTC CAT Core, the EORTC QLQ-C30, the SF-36, and the FACT-G as well as the PROMIS item bank covering the Ability to Participate in Social Roles and Activities. Following an established methodology we linked item content to the International Classification of Functioning, Disability and Health (ICF) framework. RESULTS: The content of 85 items was assigned to three ICF components ('Activities and Participation', 'Body Functions', and 'Environmental Factors'). The EORTC CAT Core RF items were mostly related to the first-level ICF categories 'Domestic life' and 'Community, social and civic life', while its SF item bank focused on 'Interpersonal interactions and relationships'. These three categories were also covered by the PROMIS social participation item bank. The FACT-G Social/Family scale focused on environmental factors ('Support and Relationships' and 'Attitudes') while the SF-36 Role-physical/emotional scales had a stronger focus on 'General tasks and demands' and 'Major life areas'. CONCLUSIONS: Our results highlight conceptual overlap and differences among PRO measures for the assessment of social health in cancer. This information may help to select the most appropriate measure for a specific setting or study purpose and to better understand the possibilities of linking scores across different PRO measures.


Assuntos
Pessoas com Deficiência , Neoplasias , Humanos , Classificação Internacional de Funcionalidade, Incapacidade e Saúde , Avaliação da Deficiência , Interação Social , Atividades Cotidianas , Qualidade de Vida
3.
Qual Life Res ; 32(4): 965-976, 2023 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-36152110

RESUMO

BACKGROUND: Health-related quality of life (HRQOL) is a key concept in pediatric oncology. This systematic review aims to update the conceptual HRQOL model by Anthony et al. (Qual Life Res 23(3):771-789, 2014), covering physical, emotional, social and general HRQOL aspects, and to present a comprehensive overview of age- and disease-specific HRQOL issues in children with cancer. METHODS: Medline, PsychINFO, the Cochrane Database for Systematic Reviews (CDSR), and the COSMIN database were searched (up to 31.12.2020) for publications using patient-reported outcome measures (PROMs) and qualitative studies in children with cancer (8-14-year) or their parents. Items and quotations were extracted and mapped onto the conceptual model for HRQOL in children with cancer mentioned above. RESULTS: Of 2038 identified studies, 221 were included for data extraction. We identified 96 PROMS with 2641 items and extracted 798 quotations from 45 qualitative studies. Most items and quotations (94.8%) could be mapped onto the conceptual model. However, some adaptations were made and the model was complemented by (sub)domains for 'treatment burden', 'treatment involvement', and 'financial issues'. Physical and psychological aspects were more frequently covered than social issues. DISCUSSION: This review provides a comprehensive overview of HRQOL issues for children with cancer. Our findings mostly support the HRQOL model by Anthony et al. (Qual Life Res 23(3):771-789, 2014), but some adaptations are suggested. This review may be considered a starting point for a refinement of our understanding of HRQOL in children with cancer. Further qualitative research will help to evaluate the comprehensiveness of the HRQOL model and the relevance of the issues it encompasses.


Assuntos
Neoplasias , Qualidade de Vida , Humanos , Criança , Qualidade de Vida/psicologia , Neoplasias/psicologia , Pesquisa Qualitativa , Medidas de Resultados Relatados pelo Paciente
4.
Qual Life Res ; 32(6): 1683-1691, 2023 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-36635414

RESUMO

PURPOSE: Serial assessment of health condition based on self-report made by children and their proxies has consistently shown a lack of congruence. The study explored the discrepancies between mother's, father's, and children's reports on health-related quality of life (HRQOL) during the first two months of pediatric cancer treatment. METHODS: In this cohort study, children and parents completed the generic and cancer-specific Pediatric Quality-of-Life Inventory (PedsQL) questionnaires at initial diagnosis and in the subsequent months. Evaluation of discrepancies included intraclass correlations between mother-child and father-child dyads at different domain levels. RESULTS: Thirty-six children with a diagnosis of cancer between May 2020 and November 2021 and their parents were included in this study. At diagnosis, mother-child dyads showed better agreement on more domains of the PedsQL Generic Core Scale than father-child dyads; moderate agreement persisted for both parents at subsequent time points on the physical domain. The disease-specific PedsQL Cancer Module revealed moderate and better agreement for mother-child dyads during active cancer therapy. In particular, agreement of mother-child dyads was pronounced for domains such as worry (0.77 [95% CI 0.52-0.89, P < 0.001]), whereas fathers tended to overestimate the child's symptom burden for most of the remaining domains of the PedsQL Cancer Module. CONCLUSION: This cohort study shows that both parent proxy reports can provide valid information on child's HRQOL, but that fathers tend to overestimate, particularly for non-observable domains. Proxy reports derived from mothers more closely agreed with children's HRQOL and might be more weighted, if there is uncertainty between parents.


Assuntos
Mães , Neoplasias , Feminino , Humanos , Criança , Masculino , Qualidade de Vida/psicologia , Estudos de Coortes , Pais , Inquéritos e Questionários , Pai
5.
J Med Internet Res ; 25: e49476, 2023 09 21.
Artigo em Inglês | MEDLINE | ID: mdl-37733409

RESUMO

BACKGROUND: Patient-reported outcomes are considered the gold standard for assessing subjective health status in oncology patients. Electronic assessment of patient-reported outcomes (ePRO) has become increasingly popular in recent years in both clinical trials and practice. However, there is limited evidence on how well older patients with cancer can complete ePRO assessments. OBJECTIVE: We aimed to investigate how well adult patients with cancer of different age ranges could complete ePRO assessments at home and in a treatment facility and to identify factors associated with the ability to complete questionnaires electronically. METHODS: This retrospective longitudinal single-center study involved survivors of cancer who participated in inpatient rehabilitation. Patients completed ePRO assessments before rehabilitation at home (T1) and after rehabilitation at the facility (T2). We analyzed the rate of patients who could complete the ePRO assessment at T1 and T2, the proportion of patients who required assistance, and the time it took patients to complete standardized questionnaires. Multivariate logistic regression analyses were conducted to identify predictors of ePRO completion rate and the need for assistance. RESULTS: Between 2017 and 2022, a total of 5571 patients were included in this study. Patients had a mean age of 60.3 (SD 12.2) years (range 18 to 93 years), and 1135 (20.3%) of them were classified as geriatric patients (>70 years). While more than 90% (5060/5571) of all patients completed the ePRO assessment, fewer patients in the age group of >70 years (924/1135, 81.4% at T1 vs 963/1135, 84.8% at T2) completed the assessment. Approximately 19% (1056/5571) of patients reported a need for assistance with the ePRO assessment at home, compared to 6.8% (304/4483) at the institution. Patients older than 70 years had a significantly higher need for assistance than those in younger age groups. Moreover, a gender difference was observed, with older women reporting a higher need for assistance than men (71-80 years: women requiring assistance 215/482, 44.6% vs men 96/350, 27.4%; P<.001 and >80 years: women 102/141, 72.3% vs men 57/112, 50.9%; P<.001). On average, patients needed 4.9 (SD 3.20) minutes to remotely complete a 30-item questionnaire (European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire) and patients in the older age groups took significantly longer compared to younger age groups. Lower age and higher physical functioning were the clearest predictors for both the ePRO completion rate and the need for assistance in the multivariate regression analysis. CONCLUSIONS: This study's results indicate that ePRO assessment is feasible in older individuals with cancer, but older patients may require assistance (eg, from relatives) to complete home-based assessments. It may be more feasible to conduct assessments in-house in this population. Additionally, it is crucial to carefully consider which resources are necessary and available to support patients in using ePRO devices.


Assuntos
Neoplasias , Qualidade de Vida , Adulto , Masculino , Humanos , Feminino , Idoso , Adolescente , Adulto Jovem , Pessoa de Meia-Idade , Idoso de 80 Anos ou mais , Estudos Retrospectivos , Neoplasias/terapia , Pacientes Internados , Eletrônica , Medidas de Resultados Relatados pelo Paciente
6.
Prax Kinderpsychol Kinderpsychiatr ; 72(4): 361-380, 2023 May.
Artigo em Alemão | MEDLINE | ID: mdl-37218558

RESUMO

In the project "Resilient Children", a resilience promotion program for kindergartens and elementary schools was directly applied and evaluated during the COVID-19-crisis.The aim of the study was to strengthen the three sources of resilience according to Grotberg (1995) I HAVE, I AM and I CAN through targeted exercises and resilience-promoting communication (transfer to everyday life). Additionally, gender differences with regard to the effect of the programme were addressed. "Resilient Children" was evaluated at the impact level (pre-post design) and process level. Eight kindergartens and three elementary schools with 125 children participated. A total of 122 teachers and 70 parents provided information about the children. The results at the impact level showed that from the parent and teacher perspective, and from the self-perspective (children), the three sources of resilience were significantly strengthened. With regard to gender differences, the results from the perspective of teachers and parents showed that girls were characterised by greater changes than boys. Compared to the girls, the physical andmental well-being of the boys improved fromthe parents' point of view. The results of the process evaluation revealed a high level of motivation and enthusiasm for participation in the programme on the part of participating children and teachers. The success of "Resilient Children" depends on the identification of the teachers with the program.


Assuntos
COVID-19 , Masculino , Feminino , Humanos , Criança , Avaliação de Programas e Projetos de Saúde , Instituições Acadêmicas , Escolaridade , Motivação
7.
J Man Manip Ther ; 32(5): 464-477, 2024 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-38381584

RESUMO

The number of low back pain (LBP) cases is projected to increase to more than 800 million by 2050. To address the substantial burden of disease associated with this rise in prevalence, effective treatments are needed. While clinical practice guidelines (CPG) consistently recommend non-pharmacological therapies as first-line treatments, recommendations regarding manual therapy (MT) in treating low back pain vary. The goal of this narrative review was to critically summarize the available evidence for MT behind these recommendations, to scrutinize its mechanisms of action, and propose some actionable steps for clinicians on how this knowledge can be integrated into a person-centered approach. Despite disparate recommendations from CPG, MT is as effective as other available treatments and may be offered to patients with LBP, especially as part of a treatment package with exercise and education. Most of the effects of MT are not specific to the technique. MT and other interventions share several mechanisms of action that mediate treatment success. These mechanisms can encompass patients' expectations, prior experiences, beliefs and convictions, epistemic trust, and nonspecific contextual effects. Although MT is safer than opioids for patients with LBP, this alone is insufficient. Our goal is to encourage clinicians to shift away from outdated and refuted ideas in MT and embrace a person-centered approach rooted in a comprehensive biopsychosocial framework while incorporating patients' beliefs, addressing illness behaviors, and seeking to understand each patient's journey.


Assuntos
Dor Lombar , Manipulações Musculoesqueléticas , Humanos , Dor Lombar/terapia , Manipulações Musculoesqueléticas/métodos , Resultado do Tratamento
8.
J Clin Epidemiol ; 165: 111203, 2024 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-37918641

RESUMO

OBJECTIVE: To provide equipercentile equating of physical function (PF) scores from frequently used patient-reported outcome measures (PROMs) in cancer patients to facilitate data pooling and comparisons. STUDY DESIGN AND SETTING: Adult cancer patients from five European countries completed the European Organization for Research and Treatment of Cancer (EORTC) computer adaptive test (CAT) Core, EORTC Quality of Life Questionnaire Version 3.0 (QLQ-C30), Functional Assessment of Cancer Therapy - General (FACT-G), 36-item Short Form Health Survey (SF-36), and the Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function 20a short form. The R package "equate" was used to establish conversion tables of PF scores on those measures with a bivariate rank correlation of at least 0.75. RESULTS: In total, 953 patients with cancer (mean age 58.9 years, 54.7% men) participated. Bivariate rank correlations between PF scores from the EORTC CAT Core, EORTC QLQ-C30, SF-36, and PROMIS were all above 0.85, but below 0.69 for the FACT-G. Conversion tables were established for all measures but the FACT-G. These tables indicate which score from one PROM best matches the score from another PROM and provide standard errors of converted scores. CONCLUSION: Our analysis indicates that linking of PF scores from both EORTC measures (CAT and QLQ-C30) with PROMIS and SF-36 is possible, whereas the physical domain of the FACT-G seems to be different. The established conversion tables may be used for comparing results or pooling data from clinical studies using different PROMs.


Assuntos
Neoplasias , Qualidade de Vida , Adulto , Masculino , Humanos , Pessoa de Meia-Idade , Feminino , Neoplasias/terapia , Inquéritos e Questionários , Europa (Continente) , Medidas de Resultados Relatados pelo Paciente
9.
Musculoskeletal Care ; 21(2): 338-354, 2023 06.
Artigo em Inglês | MEDLINE | ID: mdl-36539952

RESUMO

INTRODUCTION: Due to demographic changes and increasing knee osteoarthritis (KOA) prevalence, the incidence of total knee arthroplasties (TKA) is constantly rising. Clinical practice guidelines for the treatment of KOA unanimously recommend non-surgical interventions such as exercise, education, and weight reduction in overweight patients. The aim of this systematic review is to determine the proportion of patients with end-stage KOA who attended physiotherapy (PT) prior to TKA. METHODS: A systematic literature search was carried out in the medical databases MEDLINE (via Pubmed), PEDro, and EBSCO in August of 2022. Studies were included regardless of their design, if they reported the proportion of patients with a diagnosis of primary KOA, who participated in PT prior to undergoing TKA. Study quality assessment was performed by two independent authors using the Joanna Briggs Institutes Checklist for studies reporting prevalence data. Results were presented by using a narrative synthesis. RESULTS: Eighteen studies, comprising 579,718 patients, were identified in this systematic review. PT utilisation prior to TKA ranged from 10% to 73% for patients with advanced KOA. Only two studies showed PT utilisation rates of 60% or higher. Female gender, higher income, better socioeconomic status, higher education levels, older age were associated with PT utilisation. Data for other predicting factors was conflicting. DISCUSSION: This review shows substantial variation in the utilisation of PT in patients with end-stage KOA. This is concerning, considering the uniform recommendation from clinical practice guidelines for non-surgical treatments like exercise and education in patients with KOA, which are mostly provided by physiotherapists.


Assuntos
Artroplastia do Joelho , Osteoartrite do Joelho , Humanos , Feminino , Osteoartrite do Joelho/cirurgia , Osteoartrite do Joelho/diagnóstico , Artroplastia do Joelho/métodos , Modalidades de Fisioterapia , Exercício Físico , Redução de Peso
10.
J Patient Rep Outcomes ; 7(1): 2, 2023 01 19.
Artigo em Inglês | MEDLINE | ID: mdl-36656407

RESUMO

BACKGROUND: With increasing survival rates in pediatric oncology, the need to monitor health-related quality of life (HRQOL) is becoming even more important. However, available patient-reported outcome measures (PROMs) have been criticized. This review aims to systematically evaluate the content validity of PROMs for HRQOL in children with cancer. METHODS: In December 2021, a systematic literature search was conducted in PubMed. PROMs were included if they were used to assess HRQOL in children with cancer and had a lower age-limit between 8 and 12 years and an upper age-limit below 21 years. The COSMIN methodology for assessing the content validity of PROMs was applied to grade evidence for relevance, comprehensiveness, and comprehensibility based on quality ratings of development studies (i.e., studies related to concept elicitation and cognitive interviews for newly developed questionnaires) and content validity studies (i.e., qualitative studies in new samples to evaluate the content validity of existing questionnaires). RESULTS: Twelve PROMs were included. Due to insufficient patient involvement and/or poor reporting, the quality of most development studies was rated 'doubtful' or 'inadequate'. Few content validity studies were available, and these were mostly 'inadequate'. Following the COSMIN methodology, evidence for content validity was 'low' or 'very low' for almost all PROMs. Only the PROMIS Pediatric Profile had 'moderate' evidence. In general, the results indicated that the PROMs covered relevant issues, while results for comprehensiveness and comprehensibility were partly inconsistent or insufficient. DISCUSSION: Following the COSMIN methodology, there is scarce evidence for the content validity of available PROMs for HRQOL in children with cancer. Most instruments were developed before the publication of milestone guidelines and therefore were not able to fulfill all requirements. Efforts are needed to catch up with methodological progress made during the last decade. Further research should adhere to recent guidelines to develop new instruments and to strengthen the evidence for existing PROMs.


Assuntos
Neoplasias , Qualidade de Vida , Humanos , Criança , Qualidade de Vida/psicologia , Medidas de Resultados Relatados pelo Paciente , Inquéritos e Questionários , Neoplasias/terapia , Pesquisa Qualitativa
11.
Neuropsychiatr ; 37(2): 57-64, 2023 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-36480103

RESUMO

BACKGROUND: Group psychotherapy is an effective treatment for patients with mental health issues. This study aims to evaluate data on the effectiveness of a cost-free short-term outpatient group psychotherapy project for patients with mixed mental health issues in Tyrol, Austria. METHODS: In this naturalistic observational study, outpatients taking part in the psychotherapeutic group treatment between spring 2018 and spring 2020 were included. Patients completed the patient health questionnaire (PHQ-D), an item of the working ability index (WAI) and single items on symptom burden, treatment expectation and perceived benefit before the first (T0) and/or last group session (T1). Mean changes were investigated using repeated measure analyses of variance (rANOVA). RESULTS: A total of 98 patients were included in the study. Statistically significant improvements with medium to large effect sizes were observed for depression (η2 = 0.22, p < 0.001), somatization (η2 = 0.10, p = 0.008), anxiety (η2 = 0.18, p < 0.001), and subjective working ability (η2 = 0.22, p < 0.001). Neither age (p = 0.85), sex (p = 0.34), baseline symptoms (p = 0.29-0.77), nor previous experience with individual (p = 0.15) or group psychotherapy (p = 0.29) were associated with treatment outcome. However, treatment expectation at baseline was significantly associated with the patients' perception of the treatment benefit (r = 0.39, p < 0.001). CONCLUSION: Our study highlights the benefit of outpatient short-term group psychotherapy for individuals with mental health issues. Group psychotherapy should be offered free of charge to individuals with mental health issues by social health providers.


Assuntos
Saúde Mental , Psicoterapia de Grupo , Humanos , Psicoterapia , Pacientes Ambulatoriais , Resultado do Tratamento
12.
Front Psychiatry ; 14: 1150422, 2023.
Artigo em Inglês | MEDLINE | ID: mdl-37252135

RESUMO

Background: Inpatient psychosomatic rehabilitation is a key treatment for patients with mental health issues. However, knowledge about critical success factors for beneficial treatment outcomes is scarce. The aim of this study was to evaluate the association of mentalizing and epistemic trust with the improvement of psychological distress during rehabilitation. Methods: In this naturalistic longitudinal observational study, patients completed routine assessments of psychological distress (BSI), health-related quality of life (HRQOL; WHODAS), mentalizing (MZQ), and epistemic trust (ETMCQ) before (T1) and after (T2) psychosomatic rehabilitation. Repeated measures ANOVA (rANOVAs) and structural equation models (SEMs) were calculated to investigate the association of mentalizing and epistemic trust with the improvement in psychological distress. Results: A total sample of n = 249 patients were included in the study. Improvement in mentalizing was correlated with improvement in depression (r = 0.36), anxiety (r = 0.46), and somatization (r = 0.23), as well as improved cognition (r = 0.36), social functioning (r = 0.33), and social participation (r = 0.48; all p < 0.001). Mentalizing partially mediated changes in psychological distress between T1 and T2: the direct association decreased from ß = 0.69 to ß = 0.57 and the explained variance increased from 47 to 61%. Decreases in epistemic mistrust (ß = 0.42, 0.18-0.28; p < 0.001) and epistemic credulity (ß = 0.19, 0.29-0.38; p < 0.001) and increases in epistemic trust (ß = 0.42, 0.18-0.28; p < 0.001) significantly predicted improved mentalizing. A good model fit was found (χ2 = 3.248, p = 0.66; CFI = 0.99; TLI = 0.99; RMSEA = 0.000). Conclusion: Mentalizing was identified as a critical success factor in psychosomatic inpatient rehabilitation. A key component to increase mentalizing in this treatment context is the improvement of epistemic mistrust.

13.
Cancers (Basel) ; 14(19)2022 Oct 04.
Artigo em Inglês | MEDLINE | ID: mdl-36230777

RESUMO

Rehabilitation is a key element in improving health-related quality of life (HRQOL) for pediatric cancer survivors. The aim of this study was to present data from a multidisciplinary inpatient rehabilitation treatment. Children took part in a four-week multidisciplinary family-oriented inpatient rehabilitation. A total of 236 children (>5−21 years) and 478 parents routinely completed electronic patient-reported outcomes (ePROs), performance-based assessments, and clinician-rated assessments before (T1) and at the end (T2) of rehabilitation. HRQOL was assessed with the PedsQL generic core and PedsQL cancer module. Data were analyzed using repeated measures analysis of variance (ANOVA). Statistically significant improvements with medium to large effect sizes were observed for most HRQOL scales (η2 = 0.09−0.31), as well as performance-based and clinician-rated assessments for physical activity and functional status (η2 > 0.28). Agreement between children's PROs and parents' proxy ratings was lower before (rICC = 0.72) than after (rICC = 0.86) rehabilitation. While the concordance between children and parents' assessment of changes during rehab was low to moderate (r = 0.19−0.59), the use of the performance score led to substantially increased scores (r = 0.29−0.68). The results of this naturalistic observational study thus highlight the benefits of multidisciplinary pediatric inpatient rehabilitation for childhood cancer survivors. The use of the performance score is recommended in this field.

14.
Crit Rev Oncol Hematol ; 176: 103755, 2022 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-35803454

RESUMO

BACKGROUND: Children with cancer suffer from numerous symptoms and side-effects, making supportive interventions indispensable to improve their quality of life. The gold standard for evaluating the latter is patient-reported outcome (PRO) assessment. This systematic review investigates the current practice of clinical outcome assessment (COA) in clinical trials on supportive interventions. METHODS: ClinicalTrials.gov and EudraCT were searched for trials including children and adolescents (≤21 years) with cancer receiving supportive care registered 2007-2020. The use of different types of COAs was analysed, focusing on PRO assessment and the domains measured with PRO measures (PROMs). Associations with trial characteristics were investigated using univariate and multivariable analyses. RESULTS: Of 4789 identified trials, 229 were included. Among them, 44.1 % relied on PROMs, the most commonly used COA. The proportion of trials using PROMs did not significantly differ over time. In the multivariable analysis, intervention type (higher PROM use in behavioural vs. medical interventional trials) and cancer type (higher PROM use in mixed and solid tumour samples vs. haematological samples) were significant predictors of PROM use. The majority of trials using PROMs (59.6 %) measured more than one health domain. 'Physical health' was the most frequently assessed domain (92.6 %). CONCLUSION: Less than half of registered clinical trials investigating supportive interventions for children with cancer used PROMs. This result is striking since supportive care explicitly focuses on patients' quality of life, which is best assessed using PROMs. Our systematic review underlines the need to identify barriers for PROM implementation and to improve PRO research in paediatric oncology.


Assuntos
Neoplasias , Qualidade de Vida , Adolescente , Criança , Humanos , Neoplasias/terapia , Medidas de Resultados Relatados pelo Paciente , Sistema de Registros
15.
Eur J Cancer ; 152: 90-99, 2021 07.
Artigo em Inglês | MEDLINE | ID: mdl-34090144

RESUMO

BACKGROUND: Patient-reported outcomes (PROs) are the gold standard to assess the patients' subjective health status. While both the Food and Drug Administration and European Medicines Agency recommend the use of PROs as end-points in paediatric clinical trials to support claims for medical product labelling, it is not known how often PROs are actually used. The aim of this study was to assess the usage of PRO instruments in childhood cancer clinical trials investigating anti-cancer medication. METHODS: In June 2020 ClinicalTrials and EudraCT were systematically searched for all trials including children and adolescents (≤21 years) with cancer registered between 2007 and 2020. The use of PRO measures and trials characteristics were analysed. To investigate which trial characteristics are associated with the use of PROs, a binary logistic regression was calculated. RESULTS: Of 4789 identified trials, 711 were included. The most frequent reason for exclusion was age limitation (age >21 years). Of all included trials, only 8.2% used PROs as end-points; .6% as the primary end-point. The most commonly used questionnaire was the PedsQL™ (32.8%), followed by the Patient-Reported Outcomes Measurement Information System scales (12.1%). No association was observed between the use of PROs and trial region, number of centres, trial phase, time period or intervention type (all p > .05). The use of PROs did not substantially increase over time. Only 20.3% of the closed studies had published their results. CONCLUSION: Despite recommendations of regulatory agencies, PRO assessment is extremely rare in paediatric oncology clinical trials. More efforts should be undertaken to facilitate implementation of PRO in paediatric trials to guarantee patient-centred research and treatments.


Assuntos
Antineoplásicos/administração & dosagem , Ensaios Clínicos como Assunto/estatística & dados numéricos , Neoplasias/tratamento farmacológico , Medidas de Resultados Relatados pelo Paciente , Sistema de Registros/estatística & dados numéricos , Antineoplásicos/efeitos adversos , Criança , Ensaios Clínicos como Assunto/normas , Humanos , Oncologia/normas , Oncologia/estatística & dados numéricos , Neoplasias/diagnóstico , Neoplasias/psicologia , Assistência Centrada no Paciente/normas , Qualidade de Vida , Projetos de Pesquisa/normas , Projetos de Pesquisa/estatística & dados numéricos
16.
Cancers (Basel) ; 14(1)2021 Dec 24.
Artigo em Inglês | MEDLINE | ID: mdl-35008247

RESUMO

The aim of cancer rehabilitation is to help patients regain functioning and social participation. In order to evaluate and optimize rehabilitation, it is important to measure its outcomes in a structured way. In this article, we review the different types of clinical outcome assessments (COAs), including Clinician-Reported Outcomes (ClinROs), Observer-Reported Outcomes (ObsROs), Performance Outcomes (PerfOs), and Patient-Reported Outcomes (PROs). A special focus is placed on PROs, which are commonly defined as any direct report from the patient about their health condition without any interpretation by a third party. We provide a narrative review of available PRO measures (PROMs) for relevant outcomes, discuss the current state of PRO implementation in cancer rehabilitation, and highlight trends that use PROs to benchmark value-based care. Furthermore, we provide examples of PRO usage, highlight the benefits of electronic PRO (ePRO) collection, and offer advice on how to select, implement, and integrate PROs into the cancer rehabilitation setting to maximize efficiency.

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