Interpreting the significance of changes in health-related quality-of-life scores.

1998 ◽  
Vol 16 (1) ◽  
pp. 139-144 ◽  
Author(s):  
D Osoba ◽  
G Rodrigues ◽  
J Myles ◽  
B Zee ◽  
J Pater

PURPOSE To determine the significance to patients of changes in health-related quality-of-life (HLQ) scores assessed by the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30). PATIENTS AND METHODS A subjective significance questionnaire (SSQ), which asks patients about perceived changes in physical, emotional, and social functioning and in global quality of life (global QL) and the QLQ-C30 were completed by patients who received chemotherapy for either breast cancer or small-cell lung cancer (SCLC). In the SSQ, patients rated their perception of change since the last time they completed the QLQ-C30 using a 7-category scale that ranged from "much worse" through "no change" to "much better." For each category of change in the SSQ, the corresponding differences were calculated in QLQ-C30 mean scores and effect sizes were determined. RESULTS For patients who indicated "no change" in the SSQ, the mean change in scores in the corresponding QLQ-C30 domains was not significantly different from 0. For patients who indicated "a little" change either for better or for worse, the mean change in scores was about 5 to 10; for "moderate" change, about 10 to 20; and for "very much" change, greater than 20. Effect sizes increased in concordance with increasing changes in SSQ ratings and QLQ-C30 scores. CONCLUSION The significance of changes in QLQ-C30 scores can be interpreted in terms of small, moderate, or large changes in quality of life as reported by patients in the SSQ. The magnitude of these changes also can be used to calculate the sample sizes required to detect a specified change in clinical trials.

2017 ◽  
Vol 30 (1) ◽  
pp. 47 ◽  
Author(s):  
Miguel Relvas-Silva ◽  
Rui Almeida Silva ◽  
Mário Dinis-Ribeiro

Introduction: Health-related quality of life assessment is increasingly important as it can help both clinical research and care for patients, particularly among oncological patients. Quality of Life Questionnaire – OES18 (esophageal module) and Quality of Life Questionnaire – OG25 (esophagogastric module) are the European Organization for Research and Treatment of Cancer modules for the evaluation of quality of life in patients with esophageal and esophagogastric cancers, respectively. The aim of our study was to translate, to culturally adapt and to perform a pilot testing to create the Portuguese version of both questionnaires.Material and Methods: The European Organization for Research and Treatment of Cancer guidelines were followed for translation, cultural adaptation and pilot testing of Quality of Life Questionnaire – OES18 (esophageal module) and Quality of Life Questionnaire – OG25 (esophagogastric module). The Quality of Life Questionnaire – OG25 (esophagogastric module) went through a process of forward (English → Portuguese) and backward (Portuguese → English) translation, by independent native speaker translators. After review, a preliminary version was created to be pilot tested among Portuguese patients. As a Brazilian version was already available for Quality of Life Questionnaire – OES18 (esophageal module), the questionnaire was simply culturally adapted and pilot tested. Both cancer and non-cancer patients were included.Results: Overall, 30 patients completed the Portuguese version of each questionnaire. Afterwards, a structured interview was conducted to find and report any problematic items. Troublesome items and wording were changed according to the pilot testing results. The final versions were sent to the European Organisation for Research and Treatment of Cancer Quality of Life Group and approved.Conclusion: The Portuguese versions of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire – OES18 (esophageal module) and OG25 (esophagogastric module) questionnaires are useful, reliable and valid tools for measuring health-related quality of life in patients with esophageal and esophagogastric cancers, respectively. They can now be used in clinical setting and for scientific purposes.


1999 ◽  
Vol 17 (6) ◽  
pp. 1654-1654 ◽  
Author(s):  
David Osoba ◽  
Ian F. Tannock ◽  
D. Scott Ernst ◽  
Alan J. Neville

PURPOSE: A combination of mitoxantrone plus prednisone is preferable to prednisone alone for reduction of pain in men with metastatic, hormone-resistant, prostate cancer. The purpose of this study was to assess the effects of these treatments on health-related quality of life (HQL). PATIENTS AND METHODS: Men with metastatic prostate cancer (n = 161) were randomized to receive either daily prednisone alone or mitoxantrone (every 3 weeks) plus prednisone. Those who received prednisone alone could have mitoxantrone added after 6 weeks if there was no improvement in pain. HQL was assessed before treatment initiation and then every 3 weeks using the European Organization for Research and Treatment of Cancer Quality-of-Life Questionnaire C30 (EORTC QLQ-C30) and the Quality of Life Module–Prostate 14 (QOLM-P14), a trial-specific module developed for this study. An intent-to-treat analysis was used to determine the mean duration of HQL improvement and differences in improvement duration between groups of patients. RESULTS: At 6 weeks, both groups showed improvement in several HQL domains, and only physicalfunctioning and pain were better in the mitoxantrone-plus-prednisone group than in the prednisone-alone group. After 6 weeks, patients taking prednisone showed no improvement in HQL scores, whereas those taking mitoxantrone plus prednisone showed significant improvements in global quality of life (P = .009), four functioning domains, and nine symptoms (.001 < P < .01), and the improvement (> 10 units on a scale of 0 to100) lasted longer than in the prednisone-alone group (.004 < P < .05). The addition of mitoxantrone to prednisone after failure of prednisone alone was associated with improvements in pain, pain impact, pain relief, insomnia, and global quality of life (.001 < P < .003). CONCLUSION: Treatment with mitoxantrone plus prednisone was associated with greater and longer-lasting improvement in several HQL domains and symptoms than treatment with prednisone alone.


2017 ◽  
Vol 70 (2) ◽  
pp. 271-278 ◽  
Author(s):  
Emmanuelle da Cunha Ferreira ◽  
Maria Helena Barbosa ◽  
Helena Megumi Sonobe ◽  
Elizabeth Barichello

ABSTRACT Objective: to assess self-esteem (SE) and health-related quality of life (HRQoL) in ostomized patients due to colorectal cancer. Method: cross sectional research with a quantitative approach. Three instruments were used for data collection: one instrument containing sociodemographic and clinical data, Rosenberg's Self-Esteem Scale, and the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire. Results: SE and HRQoL were considered satisfactory. Significant statistical difference was found in the social function domain and marital status, ostomy duration, location, and time; global health scale and ostomy type; cognitive function and pain in the ostomy site. There was a correlation between self-esteem and all the functional scales and the global health scale. Conclusion: knowing SE and HRQoL levels, in addition to the variables that influence them, supports ostomized patients' care planning, rehabilitation, and social autonomy.


2004 ◽  
Vol 22 (16) ◽  
pp. 3381-3388 ◽  
Author(s):  
Fabio Efficace ◽  
Patrick Therasse ◽  
Martine J. Piccart ◽  
Corneel Coens ◽  
Kristel Van Steen ◽  
...  

Purpose The purpose of this research was to evaluate whether baseline health-related quality of life (HRQOL) parameters are prognostic factors for survival in locally advanced breast cancer patients. Although the literature highlights the important role of HRQOL parameters in predicting survival in advanced metastatic disease, little evidence exists for earlier stages. Patients and Methods The overall sample consisted of 448 patients randomly assigned to receive cyclophosphamide, epirubicin, and fluorouracil versus epirubicin, cyclophosphamide, and granulocyte colony-stimulating factor. Patients were enrolled in 12 countries. HRQOL baseline scores were assessed using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30. The Cox proportional hazards regression model was used for both univariate and multivariate analyses of survival. In addition, a bootstrap resampling technique was used to assess the stability of the outcomes. Bootstrap results were then applied for model averaging purposes as a means to account for the observed model selection uncertainty. Results The final multivariate model retained inflammatory breast cancer (T4d) as the only factor predicting overall survival (OS) with a hazard ratio of 1.375 (95% CI, 1.027 to 1.840; P = .03). The presence of inflammatory breast cancer lowers the median survival time from 6.6 to 4.2 years (36% reduction). None of the preselected HRQOL variables were prognostic for OS or disease-free survival, in either the univariate or multivariate analysis. Conclusion Our findings suggest that baseline HRQOL parameters have no prognostic value in a nonmetastatic breast cancer population.


2017 ◽  
Vol 35 (15_suppl) ◽  
pp. e13541-e13541
Author(s):  
Yong Liu ◽  
Liang Wang

e13541 Background: The therapeutic methods of recurrent glioma are limited. Most studies evaluating treatment effect for brain tumor mainly focused on overall survival and progression-free survival. It is increasingly recognized that the health related quality of life (HRQL) is of great value in clinical practice when choices of treatment for recurrent glioma have to be made. We retrospectively analyzed the HRQL and treatment response of patients with recurrent glioma treated by bevacizumab (BEV) plus daily temozolomide (TMZ). Methods: Twenty patients with recurrent glioma were treated with BEV (5-10mg/kg, i.v. every 2 weeks) plus daily TMZ (daily, 50 mg/m2). The treatment response was evaluated via the RANO criteria. HRQL was measured using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire core 30 (QLQ-C30) and Brain Module (QLQ-BN20). HRQL was assessed at the baseline (before salvage therapy) and after every two cycles of BEV. Results: Twenty patients totally received 85 cycles of BEV with the median number of 4 cycles (range: 2-10). There was no patient with complete response (CR), 12 patients with partial response (PR), 5 patients with stable disease (SD), and 3 patients with progressive disease (PD). Objective response rate (CR+PR) was 60.0%. The clinical benefit rate (CR+PR+SD) was 85.0%. In the functioning domains of QLQ-C30, physical functioning, cognitive functioning and emotional functioning were significantly improved after the second cycle of BEV compared to baseline. In the symptom scales, the scores of pain and nausea/vomiting were significantly decreased. Score of global health status was significantly increased. In the QLQ-BN20, motor dysfunction, weakness of legs, headache, and drowsiness after the second cycle of BEV were also significantly improved. Conclusions: BEV plus daily TMZ could improve HRQL in patients with recurrent glioma. BEV plus daily TMZ as the salvage therapy is an effective treatment for recurrent glioma.


Cancers ◽  
2020 ◽  
Vol 12 (11) ◽  
pp. 3083 ◽  
Author(s):  
Ilse van Eck ◽  
Dide den Hollander ◽  
Ingrid M.E. Desar ◽  
Vicky L.M.N. Soomers ◽  
Michiel A.J. van de Sande ◽  
...  

Sarcoma patients experience physical and psychological symptoms, depending on age of onset, subtype, treatment, stage, and location of the sarcoma, which can adversely affect patients’ health-related quality of life (HRQoL). This study aimed to unravel the heterogeneity of sarcoma survivors’ HRQoL regarding primary sarcoma location. A cross-sectional study was conducted among Dutch sarcoma survivors (N = 1099) aged ≥18, diagnosed 2–10 years ago. Primary sarcoma locations were head and neck, chest, abdominal including retroperitoneal, pelvis including urogenital organs, axial skeleton, extremities (upper and lower), breast, skin and other locations. The European Organization for Research and Treatment of Cancer—Quality of Life Questionnaire (EORTC QLQ)-C30 was used to measure HRQoL accompanied by treatment-specific HRQoL questions. Sociodemographic and clinical characteristics were collected from the Netherlands Cancer Registry. Axial skeleton sarcomas had the lowest functioning levels and highest symptoms compared to other locations. Skin sarcomas had the highest functioning levels and lowest symptoms on most scales. Bone sarcomas scored worse on several HRQoL domains compared to soft tissue sarcomas. High prevalence of treatment-specific HRQoL issues were found per location. In conclusion, sarcomas can present everywhere, which is reflected by different HRQoL outcomes according to primary sarcoma location. The currently used HRQoL measure lacks treatment-specific questions and is too generic to capture all sarcoma-related issues, emphasizing the necessity for a comprehensive sarcoma-specific HRQoL measurement strategy.


Cancers ◽  
2020 ◽  
Vol 12 (12) ◽  
pp. 3590 ◽  
Author(s):  
Martin Eichler ◽  
Leopold Hentschel ◽  
Stephan Richter ◽  
Peter Hohenberger ◽  
Bernd Kasper ◽  
...  

Sarcomas are rare cancers with high heterogeneity in terms of type, location, and treatment. The health-related quality of life (HRQoL) of sarcoma patients has rarely been investigated and is the subject of this analysis. Adult sarcoma patients and survivors were assessed between September 2017 and February 2019 in 39 study centers in Germany using standardized, validated questionnaires (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)). Associated factors were analyzed exploratively using multivariable linear regressions. Among 1113 patients, clinically important limitations and symptoms were most pronounced in emotional (63%, 95% CI 60–66%), physical (60%, 95% CI 57–62%), role functioning (51%, 95% CI 48–54%), and pain (56%, 95% CI 53–59%) and fatigue (51%, 95% CI 48–54%). HRQoL differed between tumor locations with lower extremities performing the worst and sarcoma types with bone sarcoma types being most affected. Additionally, female gender, higher age, lower socioeconomic status, recurrent disease, not being in retirement, comorbidities, and being in treatment were associated with lower HRQoL. Sarcoma patients are severely restricted in their HRQoL, especially in functioning scales. The heterogeneity of sarcomas with regard to type and location is reflected in HRQoL outcomes. During treatment and follow-up, close attention has to be paid to the reintegration of the patients into daily life as well as to their physical abilities and emotional distress.


2004 ◽  
Vol 22 (20) ◽  
pp. 4184-4192 ◽  
Author(s):  
Pamela J. Goodwin ◽  
Marguerite Ennis ◽  
Louise J. Bordeleau ◽  
Kathleen I. Pritchard ◽  
Maureen E. Trudeau ◽  
...  

Purpose Evidence that psychosocial status and health-related quality of life (HRQOL) are associated with breast cancer (BC) outcomes is weak and inconsistent. We examined prognostic effects of these factors in a prospective cohort study. Patients and Methods Three hundred ninety-seven women with surgically resected T1 to T3, N0/N1, M0 BC completed the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (Core 30 items), Profile of Mood States, Psychosocial Adjustment to Illness Scale, Impact of Events Scale, Mental Adjustment to Cancer Scale, and the Courtauld Emotional Control Scale 2 months after diagnosis and 1 year later. Data on tumor-related factors, treatment, and outcomes were obtained prospectively from medical records, and Cox survival analyses were performed. Results Mean age was 52.0 ± 9.9 years. Two hundred twenty-five women had T1, 136 women had T2, 16 women had T3, and 20 women had TX tumors; 127 were N1. One hundred thirteen women received adjuvant chemotherapy, 130 received hormone therapy, 45 received both, and 109 received neither. We investigated 140 prognostic associations; four were found to be statistically significant at a P value of ≤ .05 (three fewer than expected by chance). Two were in the hypothesized direction of effect, and two were in the opposite direction. All arose from measurements 1 year after diagnosis, which were most susceptible to confounding by treatment. There was no evidence of consistency of associations across outcomes or questionnaires. These results are in keeping with chance as the explanation for our statistically significant findings. Conclusion HRQOL and psychosocial status at diagnosis and 1 year later are not associated with medical outcome in women with early-stage BC.


2018 ◽  
Vol 56 (11) ◽  
pp. 1354-1364 ◽  
Author(s):  
Christian Benzing ◽  
Hans-Michael Hau ◽  
Georgi Atanasov ◽  
Felix Krenzien ◽  
Tim Eisenhauer ◽  
...  

Abstract Introduction There are several well-established surgical procedures for the treatment of chronic pancreatitis (CP). The present study seeks to evaluate the perioperative and long-term outcome of these procedures. Methods All patients who had undergone pancreaticoduodenectomy (PD), duodenum-preserving pancreatic head resection (DPPHR), and distal pancreatectomy (DP) for CP were retrospectively analyzed with regards to the perioperative outcome and long-term survival. Health-related quality of life (HRQoL) was assessed using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire. Results There were 145 patients available for analysis. Major complications (grade IIIb–V) occurred in 19 %, in-hospital mortality was 4.2 %, and 90-day mortality was 3 % with no differences between the different resection groups (all p > 0.05). Ten-year survival was 58 % and was highest in the DP group (100 %) but without statistical significance (p = 0.72). The response rate of the HRQoL assessment was 45 % (65 of 145). There was a significant improvement with regards to pain and HRQoL of all resection groups compared to the preoperative group (all p < 0.05). With respect to HRQoL and pain relief, the PD, DPPHR, and DP did not differ significantly. Discussion Surgical therapy of CP can be performed safely. The 3 different types of resection performed equally with regards to complications and HRQoL.


2020 ◽  
Vol 21 (20) ◽  
pp. 7450
Author(s):  
Rytis Stakaitis ◽  
Aiste Pranckeviciene ◽  
Giedrius Steponaitis ◽  
Arimantas Tamasauskas ◽  
Adomas Bunevicius ◽  
...  

In the last decade, an increasing amount of research has been conducted analyzing microRNA expression changes in glioma tissue and its expressed exosomes, but there is still sparse information on microRNAs or other biomarkers and their association with patients’ functional/psychological outcomes. In this study, we performed a combinational analysis measuring miR-181b and miR-181d expression levels by quantitative polymerase chain reaction (qPCR), evaluating isocitrate dehydrogenase 1 (IDH1) single nucleotide polymorphism (SNP), and O-6-methylguanine methyltransferase (MGMT) promoter methylation status in 92 post-surgical glioma samples and 64 serum exosomes, including patients’ quality of life evaluation applying European Organization for Research and Treatment of Cancer (EORTC) questionnaire for cancer patients (QLQ-30), EORTC the Brain Cancer-Specific Quality of Life Questionnaire (QLQ-BN20), and the Karnofsky performance status (KPS). The tumoral expression of miR-181b was lower in grade III and glioblastoma, compared to grade II glioma patients (p < 0.05). Additionally, for the first time, we demonstrated the association between miR-181 expression levels and patients’ quality of life. A positive correlation was observed between tumoral miR-181d levels and glioma patients’ functional parameters (p < 0.05), whereas increased exosomal miR-181b levels indicated a worse functional outcome (p < 0.05). Moreover, elevated miR-181b exosomal expression can indicate a significantly shorter post-surgical survival time for glioblastoma multiforme (GBM) patients. In addition, both tumoral and exosomal miR-181 expression levels were related to patients’ functioning and tumor-related symptoms. Our study adds to previous findings by demonstrating the unique interplay between molecular miR-181b/d biomarkers and health related quality of life (HRQOL) score as both variables remained significant in the predictive glioma models.


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