scholarly journals Prediction of all-cause mortality from 24 month trajectories in patient-reported psychological, clinical and quality of life outcomes in uveal melanoma patients

Author(s):  
Stephen L. Brown ◽  
Peter L. Fisher ◽  
Laura Hope-Stone ◽  
Heinrich Heimann ◽  
Rumana Hussain ◽  
...  

AbstractA number of patient-reported outcomes (PROs) predict increased mortality after primary cancer treatment. Studies, though, are sometimes affected by methodological limitations. They often use control variables that poorly predict life expectancy, examine only one or two PROs thus not controlling potential confounding by unmeasured PROs, and observe PROs at only a single point in time. To predict all-cause mortality, this study used control variables affording good estimates of life expectancy, conducted multivariate analyses of multiple PROs to identify independent predictors, and monitored PROs two years after diagnosis. We recruited a consecutive sample of 824 patients with uveal melanoma between April 2008 and December 2014. PROs were variables shown to predict mortality in previous studies; anxiety, depression, visual and ocular symptoms, visual function impairment, worry about cancer recurrence, and physical, emotional, social and functional quality of life (QoL), measured 6, 12 and 24 months after diagnosis. We conducted Cox regression analyses with a census date of December 2018. Covariates were age, gender, marital and employment status, self-reported co-morbidities, tumor diameter and thickness, treatment modality and chromosome 3 mutation status, the latter a genetic mutation strongly associated with mortality. Single predictor analyses (with covariates), showed 6-month depression and poorer functional QoL predicting mortality, as did 6–12 month increases in anxiety and 6–12 month decreases in physical and functional QoL. Multivariate analyses using all PROs showed independent prediction by 6-month depression and decreasing QoL over 6–12 months and 12–24 months. Elevated depression scores six months post-diagnosis constituted an increased mortality risk. Early intervention for depressive symptoms may reduce mortality.

Blood ◽  
2016 ◽  
Vol 128 (22) ◽  
pp. 4793-4793
Author(s):  
Avrita Campinha-Bacote ◽  
Peter C Trask ◽  
Fabio Efficace

Abstract Introduction: Patient-reported outcomes (PROs) are now critical to more comprehensively evaluate treatment outcomes in oncology. There is convincing evidence indicating that, similarly to traditional biomarkers, PROs may also predict survival outcomes. This systematic review examined state of the art literature on the prognostic value of PROs for survival in hematological malignancies. Methods: We searched PubMed and Google Scholar from 2000-2016 for studies assessing the predictive relationship between PROs and overall survival (OS) in Acute Myelogenous Leukemia (AML), Chronic Lymphocytic Lymphoma (CLL), Diffuse Large B-Cell Lymphoma (DLBCL), indolent Non-Hodgkin's Lymphoma (iNHL), Follicular Lymphoma (FL), marginal Zone Lymphoma (mZL), Myelodysplastic Syndrome (MDS), and Multiple Myeloma (MM). Search terms included but were not limited to: quality of life, physical functioning, predictive/prognostic, survival, patient-reported outcomes, and fatigue. Studies were excluded if they did not use multivariate analyses, did not examine OS as an endpoint, were case reports, did not report results for PROs, were reported in an abstract only, or used only clinician-reported outcomes as a predictor. A pre-defined data extraction form (DEF) was used to assess the following data from each article: disease, sample size, demographics, type of PRO measures included, clinical parameters included as predictors, type of analysis, and outcomes assessed. Results: 223 articles were reviewed of which 13 met the inclusion criteria (6 AML/MDS, 3 MM, 2 aggressive lymphomas, 1 mixed heme diagnoses, and 1 DLBCL). PROs in these studies were captured with the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Core30 (EORTC QLQ-C30) or the EORTC myeloma module 24 item (MY24), a health-related quality of life questionnaire for patients with myelodysplastic syndromes (QOL-E), Functional Assessment of Cancer Treatment (FACT) or Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F), and the MD Anderson Symptom Inventory (MDASI). PROs that were independently associated with OS in multivariate analyses from the different studies were: physical function, fatigue, pain, difficulty with strenuous activity, and impaired physical performance in AML patients; physical function and fatigue in MM; fatigue in MDS; global/total QOL and functional well-being in aggressive lymphomas; drowsiness in a mixed group of heme diagnoses; and global QOL, function, and symptoms/signs in DLBCL (see Table). Baseline PROs were obtained following diagnosis of de novo or relapsed disease in 3 studies, within 6 months of registration in 1 study, and prior to any treatment in 6 studies. Conclusions: PROs related to physical functioning, fatigue, and performance were the most common predictors of OS in hematological malignancies and remained significant indicators even after accounting for clinical variables. This review highlights the prognostic value of PROs in both newly diagnosed and relapsed patients, and argues for their use in clinical decision-making and risk assessment at the time of diagnosis and pre-treatment. It also raises the question of how baseline PROs should be used in assessing new treatments within clinical trials in order to identify patients who may respond better to treatments or be in need of pre-treatment adjuvant therapy. Table Table. Disclosures Campinha-Bacote: Genentech, Inc.: Employment. Trask:Genentech, Inc.: Employment, Equity Ownership. Efficace:Lundbeck: Research Funding; Seattle Genetics: Consultancy; Bristol Myers Squibb: Consultancy; TEVA: Consultancy, Research Funding.


2015 ◽  
Vol 33 (3_suppl) ◽  
pp. 706-706
Author(s):  
Pierre Y. Cheung ◽  
Tian Yang Darren Liu ◽  
Jason D. Kim ◽  
Winson Y. Cheung

706 Background: Patient-reported measures such as psychosocial wellbeing and quality of life have been reported to correlate with cancer survival, but the specific factors within these constructs that associate with outcomes remains poorly defined. Our aim was to examine the effect of baseline anxiety and depression on OS in a population-based cohort of CRC patients. Methods: Patients diagnosed with CRC in 2008, referred to any 1 of 5 regional cancer centers in British Columbia, and who completed a baseline questionnaire to evaluate anxiety and depression were reviewed. We developed a scoring system based on these patient-reported survey data to characterize intensity and subsequently categorized patients as having no, mild, moderate or severe anxiety and/or depression. Vital statistics were captured by medical records. Unadjusted Kaplan-Meier methods and multivariate Cox regression models that controlled for additional socio-demographic and clinical characteristics were constructed to correlate anxiety and depression with OS. Results: A total of 449 patients were included: median age was 66 years (range 26-92), 52% were men, and 69% were white. A significant proportion of respondents reported anxiety (58%) or depression (45%) at baseline. Among them, the majority indicated their anxiety and depressive symptoms were severe (43% and 43%, respectively). Women and those who were single or unmarried were more likely to have anxiety and depression (p<0.001 and p=0.02, respectively). In unadjusted analyses, we observed a trend where increased severity of anxiety (p=0.07) and depression (p=0.04) correlated with worse outcomes. In Cox regression that considered other prognostic factors, however, this observation failed to persist, and neither anxiety nor depression associated with OS (Table). Conclusions: The impact of psychosocial wellbeing and quality of life on CRC outcomes that have been previously described in the literature are unlikely to be mediated through baseline anxiety or depression. [Table: see text]


2021 ◽  
Vol 50 (Supplement_1) ◽  
Author(s):  
Aung Zaw Zaw Phyo ◽  
Joanne Ryan ◽  
David Gonzalez-Chica ◽  
John McNeil ◽  
Robyn Woods ◽  
...  

Abstract Background Health-related quality of life (HRQoL) is a measure of an individual’s self-perceived health status. Few studies have examined HRQoL as a risk factor for mortality. This study examined whether HRQoL predicts all-cause mortality in older community-dwelling individuals from Australia and the United States enrolled in the Aspirin in Reducing Events in the Elderly (ASPREE) trial, and if this association varies across gender. Methods The 19,106 persons aged 65–98 years and free of known major life-limiting disease, who completed the 12-item short form (SF-12) HRQoL at ASPREE-baseline (2010–2014) were followed prospectively until 2017 for all-cause mortality. Cox proportional-hazard models were used to determine the association between the physical (PCS) and mental component scores (MCS) of HRQoL and all-cause mortality, adjusting for sociodemographic factors, health-related behaviours, and clinical measures. Results There were 1,052 deaths over a median 4.7-year of follow-up, with 11.9 events per 1,000 person-years. A 10-unit increase in PCS was associated with a 17% decrease in all-cause mortality (95%CI: 0.77, 0.89). MCS was not associated with all-cause mortality. There was no evidence these associations were different between males and females (P-values for interaction: PCS 0.13 and MCS 0.44). Conclusions PCS, but not MCS, was inversely associated with all-cause mortality in this large cohort of healthy older individuals. Key messages Our findings support the decision of the Australian Commission on Safety and Quality in Health Care to incorporate the SF-12 into the routine collection of Patient Reported Outcome Measures as a policy goal for the Australian health system.


2021 ◽  
Vol 5 (Supplement_1) ◽  
pp. A401-A402
Author(s):  
Anju A Paul ◽  
Mary T Korytkowski

Abstract Background: MODY 5 is an infrequently reported form of monogenic diabetes attributed to deletions of chromosome 17q12 with impaired expression of HNF1β (Hepatocyte Nuclear Factor 1 Beta). We report a patient who presented with hyperglycemia and hypomagnesemia with an eventual diagnosis of MODY5 that responded to treatment with the SGLT2 inhibitor (SGLT2i), canagliflozin. Clinical case: A 64-year-old male diagnosed with diabetes at age 60 and treated with glimepiride and metformin (HbA1c 6.1–6.2% without hypoglycemia) presented to establish care. He had a prior history of hypermagnesuric hypomagnesemia (serum Magnesium (Mg) 1.4 ± 0.3 mg/dl with Fractional Excretion of Mg (FEMg) 32 ± 3% [values &gt;3–4% in the setting of normal renal function and hypomagnesemia indicates renal Mg loss]) that developed while taking Triamterene- HCTZ for hypertension, prompting discontinuation. Treatment with oral and intravenous (IV) Magnesium along with Amiloride failed to normalize serum Mg levels. Genetic evaluation revealed 17q12 deletion consistent with a diagnosis of MODY 5. Referral to nephrology resulted in discontinuation of glimepiride and addition of canagliflozin 100 mg titrated to 300 mg daily. Mg levels normalized (serum Mg level 1.9 ± 0.1 mg/dL) within 8 weeks of canagliflozin therapy, allowing discontinuation of IV Mg and patient reported improvement in physical stamina and quality of life. At his 1 year follow up visit, his serum Mg remains stable at 1.8mg/dl with a FEMg of 22 ± 2.5%. His current therapy includes Metformin 2 gm, Canagliflozin 300 mg, Amiloride 10 mg tid, and oral Mg. Discussion: Prior to introduction of the SGLT2i, MODY 5 patients required oral and IV Mg repletion in combination with amiloride to achieve near normal Mg levels. Several clinical trials with SGLT2i demonstrated dose and agent dependent improvement in Mg levels in patients with type 2 diabetes. Proposed explanations include reductions in eGFR, changes in intraluminal electrical potential, and activation of renin angiotensin aldosterone system. Mg replacement results not only in symptomatic improvement, but has also been demonstrated to reduce risk of stroke and all-cause mortality. In summary, SGLT2 inhibitors in patients with MODY 5 can be effective in restoring normal Mg levels, improving quality of life, and reducing all cause mortality.


2019 ◽  
Vol 37 (15_suppl) ◽  
pp. TPS6650-TPS6650
Author(s):  
Dragan Trivanovic ◽  
Irena Hrstic ◽  
Anuska Budisavljevic ◽  
Boris Kopic ◽  
Bruno Nincevic

TPS6650 Background: Accurate evaluation of symptom intensities is essential for optimal cancer care and improving the quality of life of patients. An inappropriate interpretation of symptoms may lead to treatment outcomes failure, overdose of medication, or may leave the patients undertreated. However, the perception of symptoms can vary between the treating physician and patient. Physicians appear to underestimate the patient symptoms. And this variation in the perception of side effects can lead to wrong assumptions and subsequent treatment changes, affecting treatment effectiveness and quality of life. There is growing interest to enhance symptom monitoring during routine cancer care using patient-reported outcomes, leaving open the question of whether the benefits of systems to reveal self-reports outweigh their added cost. There are several tools for assessment of symptoms in oncology. In cancer treatment clinical trials, the standard source of adverse symptom data is clinician reporting by use of items from PRO-CTCAE, developed by NCI. To address these questions, we conducted a single-center prospective trial to test whether systematic tablet computer-based collection of patient-reported symptoms during chemotherapy treatment, with automated alerts to clinicians for severe adverse events (grade 3-4) will change in questionnaire score at 6 months compared with baseline. Secondary endpoints will include difference in unscheduled clinic visits frequency, and survival. Methods: Patients initiating chemotherapy at General Hospital Pula Oncology Clinic for advanced or metastatic gastrointestinal, lung, breast, genitourinary, or gynecologic cancers will be enrolled in a nonblinded, prospective trial of self-reporting of symptoms, compare with usual care. Patients receiving chemotherapy and their clinicians will be independently asked on the same day to complete 10 symptoms (including fatigue, pain, nausea, vomiting, diarrhea, dysgeusia, appetite, sleep disturbance, fever and hair loss). Participants will remain on study until discontinuation of cancer treatment, withdrawal, or death. All participants will provide written informed consent and followed for up to 28 months or until death. To compare how patient’s vs clinician’s reports relate to clinical events, a time-dependent Cox regression model adjusted for covariates including cancer type, age, sex, and education level will be used to measure associations between reaching particular grade severity thresholds with the risk of death and unscheduled clinic visits. Clinical trial information: 2019-000855-15.


BMJ Open ◽  
2020 ◽  
Vol 10 (2) ◽  
pp. e033228 ◽  
Author(s):  
Peter J Blankestijn ◽  
Kathrin I Fischer ◽  
Claudia Barth ◽  
Krister Cromm ◽  
Bernard Canaud ◽  
...  

IntroductionEnd-stage kidney disease (ESKD) is a major public health problem affecting more than 2 million people worldwide. It is one of the most severe chronic non-communicable diseases. Haemodialysis (HD) is the most common therapeutic option but is also associated with a risk of cardiovascular events, hospitalisation and suboptimal quality of life. Over the past decades, haemodiafiltration (HDF) has become available. Although high-dose HDF has shown some promising survival advantage compared to conventional HD, the evidence remains controversial. A Cochrane systematic review found, in low-quality trials, with various convective forms of dialysis, a reduction in cardiovascular, but not all-cause mortality and the effects on non-fatal cardiovascular events and hospitalisation were uncertain. In contrast, an individual patient data analysis suggested that high-dose HDF reduced both all-cause and cardiovascular mortality compared to HD. In view of these discrepant results, a definitive trial is required to determine whether high-dose HDF is preferable to high-flux HD. The comparison of high-dose HDF with high-flux HD (CONVINCE) study will assess the benefits and harms of high-dose HDF versus a conventional high-flux HD in adults with ESKD.Methods and analysisThis international, prospective, open label, randomised controlled trial aims to recruit 1800 ESKD adults treated with HD in nine European countries. Patients will be randomised 1:1 to high-dose HDF versus continuation of conventional high-flux HD. The primary outcome will be all-cause mortality at 3 years’ follow-up. Secondary outcomes will include cause-specific mortality, cardiovascular events, all-cause and infection-related hospitalisations, patient-reported outcomes (eg, health-related quality of life) and cost-effectiveness.Ethics and disseminationThe CONVINCE study will address the question of benefits and harms of high-dose HDF compared to high-flux HD for kidney replacement therapy in patients with ESKD with a focus on survival, patient perspectives and cost-effectiveness.Trial registration numberNetherlands National Trial Register (NTR 7138).


2020 ◽  
Vol 48 (6) ◽  
pp. E17
Author(s):  
Aryan Shay ◽  
Morgan Sturgis ◽  
Ethan M. Ritz ◽  
Andre Beer-Furlan ◽  
Lorenzo Muñoz ◽  
...  

OBJECTIVEEndoscopic pituitary surgery (EPS) via the endonasal transsphenoidal approach is well established as an effective treatment modality for sellar masses. The objective of this study was to determine the relationship between key patient and operative variables and rhinological outcomes as determined by the 22-item Sino-Nasal Outcome Test (SNOT-22) and endoscopic scores following EPS.METHODSProspectively collected SNOT-22 scores and objective endoscopic data were analyzed from a cohort of 109 patients who underwent EPS and had at least 90 days of postoperative follow-up. Trends in postoperative SNOT-22 scores were analyzed using linear mixed-effects models. Time to return to baseline endoscopic score was analyzed using Cox regression.RESULTSAfter adjusting for age and sex, the authors found that prior smokers had higher total and rhinological subdomain SNOT-22 scores (p < 0.01, 95% CI 5.82–16.39; p = 0.01, 95% CI 1.38–5.09, respectively) following EPS. Nasoseptal flap use also showed higher total and rhinological subdomain SNOT-22 scores (p = 0.01, 95% CI 1.62–12.60; p = 0.02, 95% CI 0.42–4.30, respectively). Prior sinonasal surgery and concurrent septoplasty did not affect the change in SNOT-22 total scores over time (p = 0.08, 95% CI −0.40 to 0.02; p = 0.33, 95% CI −0.09 to 0.29).CONCLUSIONSThe findings suggest that the evolution of healing and patient-reported quality of life (QOL) measures are multifaceted with contributions from two key variables. Nasoseptal flap usage and prior smoking status may adversely impact postoperative QOL. No variables were found to be associated with objective postoperative endoscopic findings.


2018 ◽  
Vol 25 (4) ◽  
pp. 140-151
Author(s):  
Markus A. Wirtz ◽  
Matthias Morfeld ◽  
Elmar Brähler ◽  
Andreas Hinz ◽  
Heide Glaesmer

Abstract. The association between health-related quality of life (HRQoL; Short-Form Health Survey-12; SF-12) and patient-reported morbidity-related symptoms measured by the Patient Health Questionnaire-15 (PHQ-15) is analyzed in a representative sample of older people in the general German population. Data from 1,659 people aged 60 to 85 years were obtained. Latent class analysis identified six classes of patients, which optimally categorize clusters of physical symptoms the participants reported: musculoskeletal impairments (39.8%), healthy (25.7%), musculoskeletal and respiratory/cardiac impairments (12.8%), musculoskeletal and respiratory impairments, along with bowel and digestion problems (12.9%), general impairments (4.9%), and general impairments with no bowel and digestion problems (4.8%). The participants’ SF-12 Physical Health Scores (η2 = .39) and their Mental Health Scores (η2 = .28) are highly associated with these latent classes. These associations remain virtually identical after controlling for age. The results provide evidence that profiles of patient-reported physical impairments correspond strongly with reduced HRQoL independently from aging processes.


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