EORTC QLQ-C30 and FACT-BMT for the measurement of quality of life in bone marrow transplant recipients: a comparison

The purpose of the study was to compare two different quality-of-life self-rating instruments, namely the EORTC QLQ-C30, developed by the quality-of-life study group of the European Organisation for Research and Treatment of Cancer, and the FACT-BMT (version 3), the Functional Assessment of Cancer Therapy - Bone Marrow Transplantation scale, which is the FACT-G(eneral measure) in combination with a module developed specifically for evaluating quality of life of bone marrow transplant (BMT) patients. Fifty-six BMT recipients completed both the EORTC QLQ-C30 and the FACT-BMT (German language version) during the same session. Questionnaire data were analyzed on a subscale basis using correlation analysis and multiple linear regression. Correlations between corresponding subscales of EORTC QLQ-C30 and the FACT-BMT ranged from r=0.30 for the emotional domain (poor agreement) to r=0.77 for global QOL (good agreement). This suggests that the instruments, despite considerable overlap, possibly focus on different aspects of QOL, in particular in addressing emotional and social issues of BMT patients. It appears that the FACT-BMT gives a more comprehensive overview regarding the multidimensional construct of quality of life. The EORTC QLQ-C30 gives more insight into the physical aspects of quality of life and helps to identify symptoms which effectively decrease quality of life from the patient's perspective. The QLQ-C30 might be improved by the incorporation of a BMT-specific module currently under development. We therefore conclude that neither of the two instruments can be replaced by the other in the assessment of QOL of BMT patients and that a direct comparison of results obtained with the two instruments is likely to be misleading.     

Systematic review of patient‐reported outcome measures in the surgical treatment of patients with esophageal cancer

Esophageal cancer is currently the eighth most common cancer worldwide. Improvements in operative techniques and neoadjuvant therapies have led to improved outcomes. Resection of the esophagus carries a high risk of severe complications and has a negative impact on health‐related quality of life (QOL). The aim of this study was to assess which patient‐reported outcome measures (PROMs) are used to measure QOL after esophagectomy for cancer. A comprehensive search of original articles was conducted investigating QOL after surgery for esophageal carcinoma. Two authors independently selected relevant articles, conducted clinical appraisal, and extracted data (PJ and JS). Out of 5893 articles, 58 studies were included, consisting of 41 prospective and 17 retrospective cohort studies, including a total of 6964 patients. These studies included 11 different PROMs. The existing PROMs could be divided into generic, symptom‐specific, and disease‐specific questionnaires. The European Organisation for Research and Treatment of Cancer (EORTC) QOL Questionnaire Core 30 (QLQ C‐30) along with the EORTC QLQ‐OESophagus module OES18 was the most widely used; in 42 and 32 studies, respectively. The EORTC and the Functional Assessment of Cancer Therapy (FACT) questionnaires use an oncological module and an organ‐specific module. One validation study was available, which compared the FACT and EORTC, showing moderate to poor correlation between the questionnaires. A great variety of PROMs are being used in the measurement of QOL after surgery for esophageal cancer. A questionnaire with a general module along with a disease‐specific module for assessment of QOL of different treatment modalities seem to be the most desirable, such as the EORTC and the FACT with their specific modules (EORTC QLQ‐OES18 and FACT‐E). Both are developed in different treatment modalities, such as in surgical patients. With regard to reproducibility of current results, the EORTC is recommended.     

Development of an EORTC questionnaire module to be used in health-related quality-of-life assessment for patients with multiple myeloma. European Organization for Research and Treatment of Cancer Study Group on Quality of Life

A multiple myeloma-specific quality-of-life questionnaire module has been designed in collaboration with the EORTC Quality-of-Life Study Group to be used in clinical trials with the EORTC QLQ-C30, a general cancer questionnaire. Strict methodology was employed to ensure thorough and appropriate development of the module. An extensive literature review was performed to identify health-related quality-of-life issues relevant to patients with multiple myeloma. Semi-structured interviews were then carried out in several European countries with health-care providers experienced in the treatment of patients with multiple myeloma, and with a group of patients with multiple myeloma, to identify the issues which were most important to patients. A questionnaire was devised from the list of issues, using a 1-week time-frame and response categories consistent with the EORTC QLQ-C30. The provisional questionnaire and the EORTC QLQ-C30 were administered to patients with multiple myeloma in each participating country with further semi-structured interviews to refine the content and design of the questionnaire. A review of the results obtained in each stage of development resulted in a 24-item myeloma-specific module, the EORTC QLQ-MY24, which assesses disease-specific symptoms and their impact on everyday life, treatment side-effects, social support, and future perspective. The module is currently undergoing further international field-testing to assess its psychometric properties.     

How the ESRD Quality Incentive Program Could Potentially Improve Quality of Life for Patients on Dialysis

For over 20 years, the quality of medical care of the Medicare ESRD Program has been a concern. The Centers for Medicare and Medicaid Services have implemented the ESRD Quality Incentive Program, which uses the principles of value-based purchasing; dialysis providers are paid for performance on predefined quality measures, with a goal of improving patient outcomes and the quality of patient care. The ESRD Quality Incentive Program measures have been criticized, because they are largely disease oriented and use easy-to-obtain laboratory-based indicators, such as Kt/V and hemoglobin, that do not reflect outcomes that are most important to patients and have had a minimal effect on survival or quality of life. A key goal of improving quality of care is to enhance quality of life, a patient-important quality measure that matters more to many patients than even survival. None of the ESRD Quality Incentive Program measures assess patient-reported quality of life. As outlined in the National Quality Strategy, the Centers for Medicare and Medicaid Services are holding providers accountable in six priority domains, in which quality measures have been and are being developed for value-based purchasing. Three measures—patient experience and engagement, clinical care, and care coordination—are particularly relevant to quality care in the ESRD Program; the 2014 ESRD Quality Incentive Program includes six measures, none of which provide data from a patient-centered perspective. Value-based purchasing is a well intentioned step to improve care of patients on dialysis. However, the Centers for Medicare and Medicaid Services need to implement significant change in what is measured for the ESRD Quality Incentive Program to be patient centered and aligned with patients’ values, preferences, and needs. This paper provides examples of potential quality measures for patient experience and engagement, clinical care, and care coordination, which if implemented, would be much more likely to enhance quality of life for patients with ESRD than present ESRD Quality Incentive Program measures.     

Quality of life,taste, olfactory and oral function following high-dose chemotherapy and allogeneic hematopoietic cell transplantation

Multiple oral complaints develop following high-dose chemo/radiotherapy and hematopoietic cell transplantation (HCT) which can influence quality of life. The purpose of this investigation was to assess quality of life, oral function, taste and smell in a cohort of patients following HCT. A general quality of life survey (the European Organization for Research and Treatment of Cancer (EORTC)) Quality of Life (QOL) questionnaire (QLQ-C30), with an added oral symptom and function scale and assessment of taste and smell was administered to a consecutive series of patients at day 90-100 post HCT. General QOL was impacted by fatigue, affecting physical, social emotional and cognitive function. While oral function scales appeared to be little affected at day 90-100 post HCT, abnormalities of taste were reported. Reports of changes in taste and smell appeared to parallel each other and changes remained at the time of the survey post-HCT. Change in taste appeared to be closely associated with dry mouth. Patients appeared to have difficulty in differentiating sour and bitter, which had been more affected than salt and sweet taste. Females appeared to report greater changes in taste than males. Increased smell sensitivity and taste change resulted in changes in food preparation in some cases, as did reported increase in sensitivity to sour and bitter taste. Acute complications are well known to affect QOL during the early period following HCT, but little assessment of long-term changes in oral QOL and taste has been conducted following transplant. The EORTC QLQ C-30 questionnaire with the oral addendum provides a measure of the quality of life and oral function, and may provide useful outcome measures for assessment of oral care prevention and management in HCT patients.     

Quality of life after treatment for prostate cancer

Quality of life is a major concern of patients when they are choosing treatment for prostate cancer. Health-related quality of life is a patient-centered variable from the field of health services research that can be measured in a valid and reliable manner. Using standardized questionnaires specifically developed to capture health-related quality of life data in men with prostate cancer, the effect of treatments on patients’ quality of life can be studied. Patients with localized disease who are undergoing radical prostatectomy tend to have more sexual and urinary dysfunction than men undergoing external beam radiation therapy, although both groups have more impairment in these areas than agematched controls. Men undergoing external beam radiation therapy have worse bowel function and more urinary distress from irritative voiding symptoms than men undergoing radical prostatectomy or age-matched controls. Recent studies of men undergoing interstitial brachytherapy indicate that these patients have less urinary leakage than those who undergo radical prostatectomy, but experience considerably more irritating voiding symptoms, which often profoundly affect their quality of life. Better information regarding the potential impact of prostate cancer treatment on quality of life will improve medical decision-making.     

International cross-cultural field validation of an European Organization for Research and Treatment of Cancer questionnaire module for patients with primary liver cancer, the European Organization for Research and Treatment of Cancer quality-of-life questionnaire HCC18

This international field validation study examined the psychometric properties and clinical validity of the European Organization for Research and Treatment of Cancer (EORTC) questionnaire module for hepatocellular carcinoma (HCC), the EORTC quality-of-life questionnaire (QLQ)-HCC18. The EORTC QLQ-HCC18 was administered with the core questionnaire, the EORTC QLQ-C30, to 272 patients from seven centers in 6 countries. Patient acceptability of the module was examined with a debriefing questionnaire, and psychometric and clinical properties were assessed. Multitrait scaling analyses confirmed the hypothesized scale structure without any scaling error, and the fatigue scale demonstrated satisfactory internal consistency. The test-retest reliability scores were high for all scales, except abdominal swelling and sexual interest. The correlations between all scales of the QLQ-HCC18 and the QLQ-C30 were low or moderate, and many scales could distinguish patients with different clinical conditions. The module demonstrated responsiveness to clinical change in pain before and after surgery and some borderline change in patients undergoing systemic treatment. Conclusion: The EORTC QLQ-HCC18 can be used as a supplementary module for the EORTC QLQ-C30 in clinical trials for patients with HCC.     

The prognostic value of quality of life scores during treatment for oesophageal cancer

BACKGROUND: Quality of life (QL) data are useful to evaluate the effectiveness of treatment. Accumulating evidence suggests that QL data may predict survival. AIMS: In this study we investigated if baseline QL scores and changes in QL scores before and after intervention are prognostic for patients with oesophageal cancer. PATIENTS: Between 1993 and 1995, 92 consecutive new patients with oesophageal cancer were studied; 89 were followed until death or the end of the study period (survival of seven patients was censored in May 1999). METHODS: All patients completed the European Organisation for Research and Treatment of Cancer (EORTC) core questionnaire (EORTC QLQ-C30) and the dysphagia scale of the oesophageal module (EORTC QLQ-OES24) before treatment and at regular intervals throughout the study. Cox's proportional hazards models assessed the impact of baseline QL variables and changes in QL scores on survival. RESULTS: Cox's proportional hazards models, adjusting for associations between QL scores, age, and TNM stage, found that physical function at baseline was significantly associated with survival (p=0.002). An increase in physical function score of 10 points corresponded to a 12% reduction in the likelihood of death at any given time (95% confidence intervals 4--18%). Further exploratory multivariable analyses suggested that improvement in emotional function six months after treatment was significantly related to longer survival (p<0.0001). CONCLUSIONS: These data provide evidence to support a relationship between patient rated scores of QL and survival. Further understanding of the associations between QL and clinical variables is needed.     

Duodenopancreatectomy versus duodenum-preserving pancreatic head excision for chronic pancreatitis.

BACKGROUND: The aim of this study was to compare two surgical procedures in the treatment for chronic pancreatitis (CP): pancreatoduodenectomy resection (classical Whipple - PD procedure, or pylorus-preserving - PPPD) to duodenum-preserving pancreatic head excision with longitudinal pancreatojejunoanastomosis (DPPHE/PJA), to define the advantages of each procedure with regard to postoperative complications, pain relief, and the quality of life. MATERIAL AND METHOD: 104 consecutive patients were included into this study. Duodenopancreatectomy was chosen when the head pancreatic mass was present or pancreatic cancer could not be ruled out (48 patients); otherwise DPPHE/PJA was performed (56 patients). Quality of life was measured prospectively on two occasions, before the procedure and during follow-up (median 39 months after surgery) using the European Organization for Research and Treatment of Cancer (EORTC) Quality-of-Life Questionnaire (QLQ-C30). The test was re-evaluated for patients suffering from CP. Pain intensity was quantified using a specially designed pain score. Early postoperative morbidity and mortality were assessed and evaluated in both groups of patients. RESULTS: Total pain score decreased significantly after surgery in both groups of patients. During the follow-up period, the global quality of life improved by 30.4% in the DPPHE/PJA group, and by 23.2% in the PD/PPPD group. Postoperative morbidity and mortality were higher in the resection group, but the differences were not significant. CONCLUSIONS: Both surgical procedures led to significant improvement in the quality of life and pain relief after surgery for CP. The EORTC QLQ-C30 was found to be a valid and readily available test for quality-of-life assessment in patients with CP.     

食管支架及幽门支架联合治疗食管胃窦重复癌1例

重复癌是指同时或异时发生于同一或不同器官,组织学类型完全不同的恶性肿瘤.重复癌约70%发生于消化器官,而消化系肿瘤易致消化道狭窄,现报告1例食管支架及幽门支架共同治疗食管和胃窦重复癌所致消化道狭窄.支架置入术可解除消化道狭窄,为一些失去手术机会的癌症晚期患者解除梗阻,提高患者的生活质量,延长生存期.     

Study of factors related to quality of life in patients with locally advanced rectal cancer.

OBJECTIVES: Given the increasing concern about the physical, psychological, and social welfare of patients surgically treated for rectal cancer, we designed a study of the factors influencing quality of life in these patients. EXPERIMENTAL DESIGN: We prospectively analyzed factors related to quality of life in a cohort of patients using the Nottingham Health Profile and the EORTC questionnaire (QLQ-CR 38). PATIENTS: A total of 116 patients with locally advanced rectal cancer surgically treated in our hospital from 1994 to 1999. RESULTS: Quality of life scores for the various factors studied showed that quality of life was worse in women, in patients with tumors in the middle third of the rectum, and in patients undergoing low anterior resection. CONCLUSIONS: Factors influencing quality of life in patients surgically treated for locally advanced rectal cancer included sex, tumor site, and surgical technique. Since only this latter factor is modifiable, we suggest that the surgical technique be individualized in persons with mid-lower and lower-third tumors of the rectum, bearing in mind that quality of life in amputated patients is, in many respects, better than that of patients with preserved sphincters.     

Psychometric Characteristics of Health-Related Quality-of-Life Questionnaires in Oropharyngeal Dysphagia

Dysphagia can have severe consequences for the patient’s health, influencing health-related quality of life (HRQoL). Sound psychometric properties of HRQoL questionnaires are a precondition for assessing the impact of dysphagia, the focus of this study, resulting in recommendations for the appropriate use of these questionnaires in both clinical practice and research contexts. We performed a systematic review starting with a search for and retrieval of all full-text articles on the development of HRQoL questionnaires related to oropharyngeal dysphagia and/or their psychometric validation from the electronic databases PubMed and Embase published up to June 2011. Psychometric properties were judged according to quality criteria proposed for health status questionnaires. Eight questionnaires were included in this study. Four are aimed solely at HRQoL in oropharyngeal dysphagia: the deglutition handicap index (DHI), dysphagia handicap index (DHI′), M.D. Anderson Dysphagia Inventory (MDADI), and SWAL-QOL, while the EDGQ, EORTC QLQ-STO 22, EORTC QLQ-OG 25 and EORTC QLQ-H&N35 focus on other primary diseases resulting in dysphagia. The psychometric properties of the DHI, DHI′, MDADI, and SWAL-QOL were evaluated. For appropriate applicability of HRQoL questionnaires, strong scores on the psychometric criteria face validity, criterion validity, and interpretability are prerequisites. The SWAL-QOL has the strongest ratings for these criteria, while the DHI′ is the most easy to apply given its 25 items and the use of a uniform scoring format. For optimal use of HRQoL questionnaires in diverse settings, it is necessary to combine psychometric and utility approaches.     

Quality of life in elderly patients with acute myeloid leukemia: patients may be more accurate than physicians

Background

The aim of this study was to evaluate changes in quality of life scores and their association with therapy and survival in unselected elderly patients with acute myeloid leukemia.

Design and Methods

From February 2003 to February 2007, 113 patients aged more than 60 years with de novo acute myeloid leukemia were enrolled in a prospective observational study. Two different quality of life instruments were employed: the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire – C30 (EORTC QLQ-C30) and a health-related quality of life questionnaire for patients with hematologic diseases (QOL-E).

Results

Forty-eight patients (42.4%) received intensive chemotherapy and 65 (57.6%) were given palliative treatments. Age greater than 70 years (P=0.007) and concomitant diseases (P=0.019) had a significant impact on treatment allocation. At diagnosis, general quality of life was affected [median QOL-E standardized score 54, interquartile range 46–70; median EORTC global score 50, interquartile range 41–66]. Most patients were given a good ECOG Performance Status (< 2), which did not correlate with the patients’ perception of quality of life. At multivariate analysis, palliative approaches (P=0.016), age more than 70 years (P=0.013) and concomitant diseases (P=0.035) each had an independent negative impact on survival. In a multivariate model corrected for age, concomitant diseases and treatment option, survival was independently predicted by QOL-E functional (P=0.002) and EORTC QLQ-C30 physical function (P=0.030) scores.

Conclusions

Quality of life could have an important role in elderly acute myeloid leukemia patients at diagnosis as a prognostic factor for survival and a potential factor for treatment decisions.     

非小细胞肺癌患者生活质量评分变化对其生存期的预测作用研究

目的研究非小细胞肺癌患者生活质量评分变化对其生存期的预测作用。方法采用EORTC QLQ-C30法评估280例非小细胞肺癌患者生活质量。并采用Cox回归模型分析患者在治疗前及3个月时两时间点的生活质量参数改变对其生存期的预测意义。结果多变量模型分析发现非小细胞肺癌患者体能、恶心呕吐、失眠症状评分改变与患者生存期之间存在相关(P值均<0.05)。病理分级为Ⅳ期患者,在治疗3个月后体能评分每增加10分,患者死亡率则下降8%(OR=0.92,P<0.05)。结论非小细胞肺癌患者的生活质量参数与其生存期存在相关,对其相关因素的干预能够改善患者的生存期。     

Quality of life and tolerance of maintenance therapy in patients with multiple myeloma

Questionnaires on the quality of life and tolerance of different parts of maintenance treatment were sent to a total of 83 patients with multiple myeloma. All patients were for more than one year on maintenance treatment which involved either interferon alpha monotherapy (I), 3 million u. three times per week till signs of relapse developed or sequence administration of interferon alpha and dexamethazone 40 mg on day 1 to 4, 10 to 13 and 20 to 23 and then after a four-week interval again interferon alpha, again till progression of the disease occurred. The patients evaluated the presence or absence of different undesirable effects of treatment during the first two weeks of treatment and throughout the year and listed their intensity into four categories defined in the questionnaire. The quality of life was evaluated by means of a basic module of the questionnaire of the European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire version 3.0 (EORTC QLQ-C30). The results of the questionnaire are to a certain extent surprising as from the patients' answers ensues that this maintenance treatment is associated with more numerous undesirable effects than the physicians realized when in contact with the patient. In this summary we can list only the most frequent effects (deterioration of eyesight, impaired sleep, depressions, irritability and unrest, chill, pain in muscles and joints, general weakness and dyspnoea). From the questionnaires on the quality of life ensues a markedly poorer quality of life of these patients as compared with the healthy population. There are however no basic differences between individual groups. The questionnaires were handed only to patients who had maintenance treatment for more than one year and thus patients were eliminated where maintenance treatment was discontinued because of undesirable effects. To give a general idea of the tolerance of the above maintenance treatment the authors mention that to the date of Aug. 31, 2001 113 patients were randomized into one of the branches of maintenance treatment. Maintenance treatment had to be discontinued in 6% patients (in two instances on account of severe hypothyroidism, in one case on account of hallucinations, in three instances on account of severe mental depression caused by this treatment). Reduction of interferon doses in 20% patients usually because of cytopenia but also on account of psychic problem. To the question what length of prolongation of life compensates the undesirable effects of maintenance treatment the following replies were obtained from patients receiving ID, possibly I: 3 months--47.6 and 38.3%, 6 months--4.3 and 10.6%, 9 months--0 and 4.3%, 12 months--47.6 and 46.8% of the addressed patients. In reply to the question whether the patients would prefer, assuming equal effectiveness, a maintenance monotherapy with interferon alpha or dexamethazone more patients preferred interferon to dexamethasone. For practice ensues from this article informing on undesirable effects of maintenance treatment and the effect of maintenance treatment on the quality of life: 1. the necessity of thorough knowledge of physicians of all possible undesirable effects as only a doctor knowing possible undesirable effects of treatment can recognize them, 2. regular monitoring not only of the activity of the basic disease, but also undesirable effects of maintenance treatment and the influence of treatment on the patients' quality of life, 3. the necessity to assess the quality of life in clinical trials as an important parameter for deciding on the way of treatment.     

Quality of life and diabetes

Quality of life is an important health outcome in its own right, representing the ultimate goal of all health interventions. This paper reviews the published, English‐language literature on self‐perceived quality of life among adults with diabetes. Quality of life is measured as physical and social functioning, and perceived physical and mental well‐being. People with diabetes have a worse quality of life than people with no chronic illness, but a better quality of life than people with most other serious chronic diseases. Duration and type of diabetes are not consistently associated with quality of life. Intensive treatment does not impair quality of life, and having better glycemic control is associated with better quality of life. Complications of diabetes are the most important disease‐specific determinant of quality of life. Numerous demographic and psychosocial factors influence quality of life and should be controlled when comparing subgroups. Studies of clinical and educational interventions suggest that improving patients' health status and perceived ability to control their disease results in improved quality of life. Methodologically, it is important to use multidimensional assessments of quality of life, and to include both generic and disease‐specific measures. Quality of life measures should be used to guide and evaluate treatment interventions. Copyright © 1999 John Wiley & Sons, Ltd.     

Development and validation of a disease-specific quality of life questionnaire (EQOL) for potentially curable patients with carcinoma of the esophagus

The objective was to develop, pretest and validate a disease-specific quality of life questionnaire for potentially curable patients with esophageal carcinoma, for use with the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) in order to assess the quality of life associated with the various treatment modalities available for this disease. Questionnaire development phase Patients were enrolled in three centres. Literature reviews, patients, family members, and health care professionals generated 195 items: symptoms (55); emotions (53); physical functioning (17); activities of daily living (ADL) (48); and leisure/social (22). Thirty-eight patients identified items of importance and assigned importance ratings on a 5-point Likert scale. Impact scores were calculated as frequency times mean item importance. Item impact scores<20/100 were excluded. Pearson's correlation co-efficients compared domains with the Medical Outcomes Study SF-20 (MOS SF-20). Fifteen items remained. Questionnaire validation phase EORTC QLQ-C30, Esophageal Quality of Life Questionnaire (EQOL), MOS SF-36 and a Global Rating of Change Questionnaire were completed at baseline, 1 week after baseline but prior to any treatment, 1 month, 3 months, and 6 months after treatment began. Reliability was assessed using paired samples correlations. Responsiveness was assessed between mean scores of changed and unchanged patients, and a responsiveness index was calculated. The MOS SF-36 was used for criterion validity. Construct validity included four a priori predictions. Sixty-five patients were enrolled in four centres in the validation phase. Paired samples correlations were high for all domains (0.749-0.889) indicating good reliability. Symptom, physical function and social domains were responsive to change at all time intervals (P<0.05). Emotional function was responsive at 1 and 3 months, activities of daily living (ADLs) at 1 and 6 months. Magnitude of change was significant when direction of change was stated. Between better and worse, magnitude of change was significant in all domains except at 6 months in symptoms, emotional and physical domains. The minimal clinically important difference was consistently around 0.5 for all domains. Minimal, moderate and large effect ranges were established. Only 2/16 time intervals had poor correlations with the SF-36, establishing criterion validity. Of the four a priori predictions for construct validity, only the second part of one prediction, in the emotional function domain, was not confirmed. We have developed a 15-item questionnaire (EQOL) which has good reliability, responsiveness and validity and is now in use in studies in Canadian centres with the EORTC QLQ-C30.