Patient‐reported outcomes enhance the survival prediction of traditional disease risk classifications: An international study in patients with myelodysplastic syndromes

Efficace, Fabio; Cottone, Francesco; Abel, Gregory A.; Niscola, Pasquale; Gaïdano, Gianluca; Bonnetain, Franck; Anota, Amélie; Caocci, Giovanni; Cronin, Angel M.; Fianchi, Luana; Breccia, Massimo; Stauder, Reinhard; Platzbecker, Uwe; Palumbo, Giuseppe A.; Luppi, Mario; Invernizzi, Rosangela; Bergamaschi, Micaela; Borin, Lorenza; Tucci, Anna Angela Di; Zhang, Huiyong; Sprangers, Mirjam A. G.; Vignetti, Marco; Mandelli, Franco

doi:10.1002/cncr.31193

Cited by 36 publications

(40 citation statements)

References 31 publications

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“…Based on this evidence, fatigue might be considered a standard stratification factor in future [ 34 ]. Moreover, prediction of clinical outcome might be improved by the combination of disease- and patient-related factors resulting in an integrated prognostic model as recently demonstrated in MDS [ 17 ].…”

Section: Discussionmentioning

confidence: 99%

“…The prevalence of symptoms and impairments was classified in three categories: not at all (0), mild (1–66), and moderate to severe (67–100) [ 6 , 16 ]. To analyze the impact of fatigue on clinical outcome, fatigue was divided in two categories as recently suggested by Efficace et al: no or mild versus strong fatigue with a cut-off at 45 on the EORTC QLQ-C30 scale (ranging from 0 = no symptom to 100 = strong symptom) [ 17 ]. The MGA included 13 questionnaires assessing performance status (WHO, Karnofsky), comorbidities (CCI, HCT-CI, CIRS-G), nutritional status (MNA), mental state (MMSE, GDS), social support (FSozu), functional capacities (IADL, ADL, TUG), and the screening tool G8.…”

Section: Methodsmentioning

confidence: 99%

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Fatigue at baseline is associated with geriatric impairments and represents an adverse prognostic factor in older patients with a hematological malignancy

et al. 2018

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Prospective data on fatigue in elderly persons with a hematological malignancy are rare. We aimed to determine the prevalence of fatigue and its association with clinical outcome and geriatric impairments in older individuals newly diagnosed with blood cancer. The EORTC QLQ-C30 and a multidimensional geriatric assessment (MGA) were performed in parallel in 149 consecutive patients aged > 67 years (median 77.8 years) at Innsbruck Medical University between January 2009 and April 2016. Fatigue as defined by EORTC QLQ-C30 was the most prevalent symptom (84%) and was significantly associated with self-reported role and physical functioning, global health status and insomnia, dyspnea, and loss of appetite (p < 0.001). Remarkably, pronounced fatigue was associated with impaired performance status and objective functional capacities in MGA, with altered depression scoring, G8 screening, and elevation of serum inflammation markers (p < 0.001). Patients with minor fatigue had a median overall survival (OS) of 26.4 months, whereas those with marked fatigue displayed an OS of 7.0 months (p < 0.001). The association between fatigue and shortened OS was supported in multivariate analyses (HR 1.74, CI 1.09–2.76; p = 0.021). Fatigue is seen to have a high prevalence and to be an adverse prognostic factor in elderly patients with a hematological malignancy. The strong impact of fatigue on clinical performance and OS emphasizes the relevance of patient-reported outcomes in individualized treatment algorithms. Patients will benefit from identification of fatigue, allowing timely interventions. The correlation between fatigue, impaired performance, nutritional status, and inflammation might suggest an underlying common pathway.

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Section: Discussionmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

Fatigue at baseline is associated with geriatric impairments and represents an adverse prognostic factor in older patients with a hematological malignancy

et al. 2018

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“… 43‐46 A randomized trial showed that screening for these symptoms was associated with a 7‐month survival advantage over usual care, which in part may have been because patients in the intervention group had better performance status at progression and thus were more likely to receive optimal treatment 46,47 . Finally, several studies have shown that PROs enhance prediction of survival in myelodysplastic syndromes, 48 multiple myeloma, 49 early‐stage colorectal cancer, 50 advanced breast cancer, 51 metastatic castration‐resistant prostate cancer, 52 metastatic renal cell carcinoma, 53 advanced cancers, 54,55 and a variety of tumor types 56,57 . In fact, some data suggest that PROs predict survival better than provider‐rated performance status 58 …”

Section: The Need For Pghd In Cancer Carementioning

confidence: 99%

Innovations in research and clinical care using patient‐generated health data

Jim

Hoogland

Brownstein

et al. 2020

CA A Cancer J Clinicians

114

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Patient-generated health data (PGHD), or health-related data gathered from patients to help address a health concern, are used increasingly in oncology to make regulatory decisions and evaluate quality of care. PGHD include self-reported health and treatment histories, patient-reported outcomes (PROs), and biometric sensor data. Advances in wireless technology, smartphones, and the Internet of Things have facilitated new ways to collect PGHD during clinic visits and in daily life. The goal of the current review was to provide an overview of the current clinical, regulatory, technological, and analytic landscape as it relates to PGHD in oncology research and care. The review begins with a rationale for PGHD as described by the US Food and Drug Administration, the Institute of Medicine, and other regulatory and scientific organizations. The evidence base for clinic-based and remote symptom monitoring using PGHD is described, with an emphasis on PROs. An overview is presented of current approaches to digital phenotyping or device-based, real-time assessment of biometric, behavioral, self-report, and performance data. Analytic opportunities regarding PGHD are envisioned in the context of big data and artificial intelligence in medicine. Finally, challenges and solutions for the integration of PGHD into clinical care are presented. The challenges include electronic medical record integration of PROs and biometric data, analysis of large and complex biometric data sets, and potential clinic workflow redesign. In addition, there is currently more limited evidence for the use of biometric data relative to PROs. Despite these challenges, the potential benefits of PGHD make them increasingly likely to be integrated into oncology research and clinical care.

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“…17,18 Still, intervention studies are sparse, and the use of PRO to improve treatment of hematological malignancies has not been well established. [19][20][21][22][23] In 2011-2012, the Blood Cancer Registry 24 decided to start a pilot project using PRO in the acute myeloid leukemia (AML) and acute lymphoblastic leukemia (ALL) registries. This pilot project was introduced as a clinical prospective study with the dual aim to evaluate both feasibility and the actual results.…”

Section: Introductionmentioning

confidence: 99%

Introducing patient‐reported outcome in the acute leukemia quality registries in Sweden

Lennmyr

Karlsson

Abrahamsson

et al. 2020

European J of Haematology

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This is an open access article under the terms of the Creative Commons Attribution-NonCommercial-NoDerivs License, which permits use and distribution in any medium, provided the original work is properly cited, the use is non-commercial and no modifications or adaptations are made. AbstractObjectives: The use of patient-reported outcome (PRO) measured outside clinical trials is not well defined. We report the first analysis of the prospective PRO study within the Swedish acute myeloid leukemia (AML) and the acute lymphoblastic leukemia (ALL) registries. Methods: PRO was requested 6 months after diagnosis. The EORTC Quality of life Questionnaire Core 30-item, the Patient Health Questionnaire-8 (PHQ-8), and questions from a Swedish National Cancer Questionnaire were used.Results: An invitation letter was sent to 398 patients; 255 (64%) responded, 60% web-based, and 40% on paper. The ALL cohort had lower physical, role and social functioning, higher symptom burden, and more financial difficulties compared to the AML cohort. A PHQ-8 score ≥ 10p, which indicates depression, was reported in 18% of the patients; 33% of these patients reported being prescribed antidepressants. The patients' overall experience of care was satisfying, but more psychological and practical support was desired. There was no difference in survival between patients who reported their PRO and those who did not. Follow-up at 2 and 4 years is ongoing.Conclusions: PRO collected in a registry-based setting is feasible, but the selection of time points and questionnaires are delicate in a diverse patient population.

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Patient‐reported outcomes enhance the survival prediction of traditional disease risk classifications: An international study in patients with myelodysplastic syndromes

Cited by 36 publications

References 31 publications

Fatigue at baseline is associated with geriatric impairments and represents an adverse prognostic factor in older patients with a hematological malignancy

Fatigue at baseline is associated with geriatric impairments and represents an adverse prognostic factor in older patients with a hematological malignancy

Innovations in research and clinical care using patient‐generated health data

Introducing patient‐reported outcome in the acute leukemia quality registries in Sweden

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