Identifying optimal cutpoints for quality of life function in patients with advanced cancer
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Abstract:
Proc Amer Assoc Cancer Res, Volume 46, 2005
4197
Background: Substantial resources have been spent to develop validated quality of life (QoL) tools in cancer. Now QoL research is focusing on utilizing QoL measurements to improve patient outcomes. One potential clinical role for QoL information is to triage patients into good, bad, and uncertain prognosis. Consequently, we used survival analysis to determine if we could transform the continuous scales of QoL data into categorical survival outcomes. Methods: Baseline QoL data were collected from 310 patients treated at our center between 04/01 and 10/03. 2 QoL tools were used: Ferrans and Powers Quality of Life Index (QLI), which has 4 functional domains, and EORTC QLQ-C30, which has 5 functional domains and 9 symptom items. Using the Wilcoxon test, differences in survival were measured in serial increments of 10 points for EORTC and 3 points for QLI (these levels are associated with significant improvement in QoL). Results from Wilcoxon test were plotted as a function of QoL cutoff points. Linear and polynomial solutions were fitted and Wald statistic identified the best fit. Results: Of 310 patients, 180 were females and 130 males, with a median age of 55 years (range 21 - 82). 64.2% had failed prior treatment. Most common cancers were breast (25%), colorectal (23.3%), and lung (17.7%). Statistical analysis indicated that Health and Function Domain (Wald Test P = 0.0194) had two cutpoints at values 10 and 20. We found a statistically significant difference in survival between patients with scores 20, the median survival being 169, 349, and 692 days respectively (p 80 were 450, 413, and 129 days respectively (p < 0.0001). Conclusions: The transformation of a QoL research tool into a clinical management tool is a challenge. As an initial step, we showed that we could convert continuous quality of life scores of the QLI Health and Functioning Domain and the rank ordered fatigue item EORTC QLQ-C30 into categorical survival outcome categories of good, bad, and uncertain. These data suggest that specific QoL domains can be powerful tools to help physicians evaluate their patients’ prognosis and subsequently, facilitate physician/patient thinking on treatment planning.Keywords:
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Cross-sectional study
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Neurofibromatosis 1 (NF1) is an inherited, multi-system, tumour suppressor disorder with variable complications that cause psychological distress and social isolation. The study aim was to develop and validate a disease-specific questionnaire to measure quality of life (QOL) in NF1 that is suitable both as an assessment tool in clinical practice and in clinical trials of novel therapy. The Impact of NF1 on Quality of Life (INF1-QOL) questionnaire was developed by a literature search for common terms, focus group (n = 6), semi-structured interviews (n = 21), initial drafts (n =50) and final 14 item questionnaire (n = 50). Bivariate correlations between items, exploratory factor analysis, correlations with severity and EuroQol were employed. INF1-QOL showed good internal reliability (Cronbach’s alpha 0.87), mean total INF1-QOL score was 8.64 (SD 6.3), median 7.00, range 0–30 (possible range 0–42); no significant correlations with age or gender. The mean total EuroQol score was 7.38 (SD 2.87), median 6.5, mean global EuroQol score was 76.34 (SD 16.56), median 80. Total INF1-QOL score correlated with total EuroQol r = 0.82, p < 0.0001. The highest impact on QOL was moderate or severe problems with anxiety and depression (32%) and negative effects of NF1 on role and outlook on life (42%). The mean inter-relater reliability for grading of clinical severity scores was 0.71 (range 0.65-0.79), and intra-class correlation was 0.92. The mean clinical severity score was 1.95 (SD 0.65) correlating r = 0.34 with total INF1-QOL score p < 0.05 and correlated 0.37 with total EuroQol score p < 0.01. The clinical severity score was mild in 17 (34%), moderate in 16 (32%) and 17 (34%) individuals had severe disease. INF1-QOL is a validated, reliable disease specific questionnaire that is easy and quick to complete. Role and outlook on life and anxiety and depression have the highest impact on QOL indicating the variability, severity and unpredictability of NF1. INFI-QOL correlates moderately with clinical severity. The moderate relationship between INF1-QOL and physician rated severity emphasizes the difference between clinical and patient perception. INFI-QOL will be useful in individual patient assessment and as an outcome measure for clinical trials.
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6122 Background: While the use of quality of life (QoL) assessments has been increasing in the clinical oncology community, few studies have examined the prognostic significance of QoL in breast cancer. To examine this issue, we investigated the association between baseline QoL and survival in breast cancer. Methods: A case series of 105 patients with stages I-IV breast cancer treated at Cancer Treatment Centers of America® at Midwestern Regional Medical Center between March 2001 and October 2003 were included in this study. QoL was evaluated using the EORTC QLQ-C30 (EORTC) and the Ferrans and Powers Quality of Life Index (QLI). Patients were dichotomized into two groups based on the median scores for all QoL domains. Kaplan Meier method was used to evaluate survival. Log-Rank test was used to study the equality of survival distributions across strata. Results: Patients with QLI health function scores above the median (17.65) had an overall median survival of 22.8 months, compared to those with scores below the median, 15.74 months (p = 0.004). Similarly, patients with global health EORTC scores above the median (58.33) had an overall median survival of 23.21 months compared to 11.57 months for those with scores below the median (p=0.002). Both associations retained statistical significance even after controlling for tumor stage (QLI health function, p = 0.003 and EORTC global health, p = 0.001). Conclusion: This study suggests that baseline QoL can provide useful prognostic information in breast cancer. Further studies should focus on more extensive evaluation of the prognostic significance of QoL in the cancer treatment setting. No significant financial relationships to disclose.
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Background: As survival rates of cancer patients are improving, the quality-of-life (QoL) is becoming the next significant clinical endpoint. However, most oncology QoL questionnaires fall short in providing clinically useful information for guiding post-surgery care. Consideration of pre-existing health issues and a scoring formula that assigns weights to different scales for patient grading may generate clinically useful QoL scores. Methods: The Quality-of-Life Questionnaire for Post Gastrectomy (QoLQ-PG), which considers pre-existing health issues, comprises 30 items across five scales (general symptom, post-gastrectomy syndrome, activity, psychological state, social relation) and an overall scale. A total of 2524 survey responses from 1035 gastric cancer (GC) patients were collected. Validity and reliability analyses were performed using the multitrait-multimethod matrix. Regression analysis was performed to determine the weight of each scale. Analysis of variance was performed using Fisher's least significant difference test. Findings: The QoLQ-PG showed good reliability, convergent validity, and discriminant validity (Cronbach's alpha: 0.704-0.840; validity diagonal: 0.529-0.786). The scoring formula accurately represented the contributions of the five scales to the overall QoL (R2 = 0.445; p < 0.001), which showed significant correlations (r = 0.228, p < 0.001) with changes in body weight, a decisive clinical index in post-gastrectomy patients. Classification of the QoLQ-PG scores into four grades allowed clear distinction among patient grades, which were also highly correlated with body weight changes (F = 23.12, p < 0.001). Interpretation: The QoLQ-PG reliably illustrated the QoL of post-gastrectomy GC patients in terms of weighted total score and scale scores, which respectively may be used to denote the level and type of post-surgery care needed. The concept and scoring formula of the QoLQ-PG may be adapted in other cancers to evaluate clinically relevant QoL and guide post-treatment plans. Funding Statement: Asan Institute for Life Sciences and Corporate Relations, Asan Medical Center, Korea Declaration of Interests: All authors have no conflicts of interest.Ethics Approval Statement: The Ethics Committee of Asan Medical Center reviewed and approved the study protocol (2015-1288).
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Abstract: Objectives: Without clear guidelines, clinicians and health care providers are often uncertain how to interpret (quality of life) QOL scores. To facilitate the interpretation, QOL scores of multiple myeloma patients at diagnosis were compared with the scores of a reference population, and the clinical significance of QOL score differences and of changes in scores over time was assessed. Methods: Data from two prospective Nordic Myeloma Study Group trials (221 patients <60 yr treated with high dose chemotherapy, and 203 patients >60 yr treated with melphalan and prednisone) were analysed. The EORTC QLQ‐C30 questionnaire was used. The results were compared with the scores of an age‐ and gender‐adjusted Norwegian reference population ( n = 3000), using a regressional approach. The magnitude of the observed differences and of score changes during follow‐up was estimated as effect size [score difference (SD)] and according to a subjective rating system as small, moderate or large. Results: At diagnosis, the most distressing problems were pain and fatigue, reduced physical functioning, limitations in role functioning and reduced overall QOL. These differences from the reference population were statistically significant ( P < 0.001), and large or moderate according to the rating systems. After the start of treatment, small to moderate improvement in mean QOL scores were observed for most domains. Conclusion: Comparison with a reference population eases the interpretation of QOL scores and prevents overestimation of symptoms and underestimation of subjective treatment response. The agreement between the two methods to evaluate the meaning of differences and changes in QOL scores was good.
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PURPOSE:To describe the quality of life(QOL) in patients with oral cancer preoperatively,and to analyze the impact of sociodemo-graphic variables and clinical features on their QOL scores. METHODS:SF-36(Chinese version) and UW-QOL (version 4.0) were used to examine QOL of 97 consecutive patients with oral squamous cell carcinoma. These patients were divided into different groups according to sociodemographic variables(age,sex,education,comorbidity) and clinical features(tumor location,tumor stage or TNM stage). The differences between groups were analyzed by Mann-Whitney U test with SPSS12.0 software package. Independent-samples t test was used for comparison between their scores of SF-36 and the normative QOL scores. RESULTS:①Compared with the age-and sex-matched population-based sample,the older patients generally showed parallel QOL scores,while in patients 60 years ,there was reduced QOL regarding the domains of RP,BP and RE; ②Tumor stage had the most powerful impact on QOL scores; ③The impact of sociodemographic variables (e.g. age,sex,comorbidity) on these QOL scores lied predominantly in parameters(e.g. VT,PF,RP and mood) reflecting the domains of physical complaints and psychological distress ; while the impact of clinical features (e.g. tumor location,tumor stage) on these QOL scores not only lied in specific problems related to oral cavity(e.g. chewing,swallowing,speech and taste),but also parameters reflecting the domains of physical complaints and psychological distress such as RP,BP and RE. CONCLUSION:A comparison with the normative QOL scores contributedto obtain more precise QOL information of patients with oral cancer. Clinical features appeared to have stronger impact on QOL than sociodemographic variables. Combination of general measures and head and neck-specific measures,for example,combination of SF-36 and UW-QOL,will evaluate QOL of oral cancer patients more comprehensively.
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Azacitidine
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Among the most widely used instruments to assess quality of life (QOL) in patients with cancer are the European Organization for Research and Treatment of Cancer core questionnaire (EORTC QLQ-C30) and the Functional Assessment of Chronic Illness Therapy, cancer instrument (FACT-G). This study compared these approaches in patients who had undergone esophagectomy for cancer. The EORTC core questionnaire and esophageal module and the FACT-G and esophageal scale were completed by 57 patients. Missing data, relationships between QOL scales and analyses of patients' preferences were examined. There were 14/2736 (0.5%) missing items from EORTC questionnaires and 45/2565 (1.8%) from FACT instruments (p 0.57) except for the social function scale (r = 0.01). EORTC symptom scores were moderately correlated with the FACT general scale, but poorly related to the FACT esophageal scale (r < 0.28). EORTC swallowing scores were moderately correlated with all FACT scales. The FACT-E and EORTC QLQ-C30 measure assess similar generic aspects of QOL (except social function). EORTC esophageal symptom scores relate poorly to FACT esophageal scales, except for swallowing. Choice of QOL measure after esophagectomy for cancer depends upon outcomes of interest. Future studies will determine which instruments are appropriate in each context.
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