Reduced quality of life in patients with chronic hepatitis C: effects of interferon treatment

BACKGROUND: Quality of life is an area of increasing interest in hepatology. Studies, so far, have assessed quality of life in patients with chronic virus C-related hepatitis in relation to antiviral therapy by means of generic questionnaires. AIM: To measure quality of life in chronic hepatitis patients without cirrhosis by means of the Nottingham Health Profile questionnaire, a measure of "distress" in comparison with the Medical Outcome Survey SF-36, an index of well-being. PATIENTS: A series of 126 outpatients with chronic hepatitis; 37 on and 89 not on active interferon treatment. METHODS: The two questionnaires were used in random order. Clinical and laboratory data were also collected. The final score of any domain of the two questionnaires, for any individual patient, was compared to age-adjusted normal values obtained in 2 random samples of Italian population. RESULTS: Patients showed a significant modification of 3 domains of Nottingham Health Profile (Energy, Social Isolation and Physical Mobility) and 6 domains of SF-36. In relation to interferon treatment, the Nottingham Health Profile questionnaire was able to detect differences in Energy, Physical Mobility and Pain, which were modified only in treated patients. SF-36 did not show any differences in relation to treatment. In addition, the Nottingham Health Profile demonstrated that treated patients had a lower prevalence of concern for family life, possibly due to expectations of treatment itself. CONCLUSIONS: Active interferon treatment causes considerable distress in chronic hepatitis C patients, adding to the perceived change in health status caused by liver disease.     

The quality of life in patients with chronic pancreatitis evaluated using the SF-12 questionnaire: A comparative study with the SF-36 questionnaire

BACKGROUND: In clinical practice there is the need to utilise a time saving questionnaire to assess the quality of life. AIMS: To establish the validity of the SF-12 questionnaire in chronic pancreatitis patients and to identify the predictors capable of modifying the physical and mental summaries in these patients. QUESTIONNAIRES: SF-12 and SF-36 questionnaires were used. SUBJECTS: One hundred and forty-one outpatients with proven chronic pancreatitis. The data of 141 sex- and age-matched Italian subjects of two normative groups (61,434 Italian subjects for SF-12 and 2031 Italian subjects for SF-36) were used as controls. RESULTS: Chronic pancreatitis patients had the SF-12 physical and mental component summaries significantly related to the SF-36 physical and mental component summaries (P<0.001). The presence of pancreatic pain and non-pancreatic surgery accounted for 41.3% in the formation of the PCS-36 score and 37.2% in that of the PCS-12 score, respectively. Gender, BMI and pancreatic pain accounted for 15.3% of the information in the formation of the MCS-36 and for 14.7% in that of the MCS-12; using these clinical variables, the loss of information in applying the SF-12 instead of the SF-36 was very low (4.1 and 0.6% for the PCS and the MCS, respectively). CONCLUSIONS: The SF-12 is a good alternative to the SF-36 in assessing the quality of life in chronic pancreatitis.     

Quality of life assessment in patients with chronic pancreatitis receiving antioxidant therapy

AIM:To undertake a baseline study comparing quality of life(QoL) in patients with chronic pancreatitis(CP) on Antox to those with CP,matched for disease duration,who were not on this medication.METHODS:CP was defined according to the Zurich classification.Sixty eight consecutive patients with CP who were taking Antox(antioxidants) were compared with 69 consecutive control CP patients not on Antox.European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core questions 30 and P...     

The Myeloproliferative Neoplasm Symptom Assessment Form (MPN-SAF): international prospective validation and reliability trial in 402 patients

Symptomatic burden in myeloproliferative neoplasms is present in most patients and compromises quality of life. We sought to validate a broadly applicable 18-item instrument (Myeloproliferative Neoplasm Symptom Assessment Form [MPN-SAF], coadministered with the Brief Fatigue Inventory) to assess symptoms of myelofibrosis, essential thrombocythemia, and polycythemia vera among prospective cohorts in the United States, Sweden, and Italy. A total of 402 MPN-SAF surveys were administered (English [25%], Italian [46%], and Swedish [28%]) in 161 patients with essential thrombocythemia, 145 patients with polycythemia vera, and 96 patients with myelofibrosis. Responses among the 3 administered languages showed great consistency after controlling for MPN subtype. Strong correlations existed between individual items and key symptomatic elements represented on both the MPN-SAF and the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-C30. Enrolling physicians' blinded opinion of patient symptoms (6 symptoms assessed) were highly correlated with corresponding patients' responses. Serial administration of the English MPN-SAF among 53 patients showed that most MPN-SAF items are well correlated (r > 0.5, P < .001) and highly reproducible (intraclass correlation coefficient > 0.7). The MPN-SAF is a comprehensive and reliable instrument that is available in multiple languages to evaluate symptoms associated with all types of MPNs in clinical trials globally.     

Long-term quality of life following pancreaticoduodenectomy

BACKGROUND/AIMS: This study examined long-term quality of life in an unselected consecutive cohort of patients undergoing pancreaticoduodenectomy, both Whipple and total, for benign and malignant disease. METHODOLOGY: Forty consecutive patients who underwent pancreaticoduodenectomy over a nine-year period formed the study group. The control group consisted of 58 age- and sex-matched patients undergoing open cholecystectomy during the same period. Quality of Life was assessed using the European Organisation for Research and Treatment of Cancer QLQ-C30 (core cancer module) and QLQ-PAN26 (pancreatic cancer module) questionnaires at a median of 42 months postoperatively. RESULTS: The Global Health Status of the study and control groups was similar, but significant differences were noted in certain individual scales. The benign group reported greater social and financial difficulties, and symptoms consistent with impaired exocrine function. The malignant group reported difficulties with daily physical and role functioning, concern for future health and individual symptoms such as fatigue, muscle weakness, and inability to gain weight. CONCLUSIONS: This study demonstrates that the overall quality of life of patients who underwent pancreaticoduodenectomy compared favorably with that of a control group. Significant differences did exist in some individual scales, in both the benign and malignant sub-groups, suggestive of exocrine insufficiency.     

Bortezomib is associated with better health-related quality of life than high-dose dexamethasone in patients with relapsed multiple myeloma: results from the APEX study

Health-related quality of life (HRQL) was prospectively measured during the phase III APEX trial of bortezomib versus dexamethasone in relapsed multiple myeloma patients. The European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Core (QLQ-C30) and Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity (NTX) side-effects questionnaires were administered at baseline and every 6 weeks up to 42 weeks. Patients receiving bortezomib (1.3 mg/m(2), days 1, 4, 8 and 11 for eight 3-week cycles, then days 1, 8, 15 and 22 for three 5-week cycles; n = 296) demonstrated significantly better mean Global Health Status over the study versus patients receiving dexamethasone (40 mg/d, days 1-4, 9-12, and 17-20 for four 5-week cycles, then days 1-4 only for five 4-week cycles; n = 302), plus significantly better physical health, role, cognitive, and emotional functioning scores, lower dyspnoea and sleep symptom scores, and better NTX questionnaire score, using multiple imputation to account for missing data. Results were similar using available-data analyses. Sensitivity analyses suggested that improved HRQL with bortezomib is at least partially explained by improved survival. These results show that bortezomib was associated with significantly better multidimensional HRQL compared with dexamethasone, consistent with the better clinical outcomes seen with bortezomib.     

Quality of life in patients with chronic pancreatitis

INTRODUCTION: Health-related quality of life is becoming a major issue in the evaluation of any therapeutic intervention in patients with chronic or hard to cure diseases. AIMS: To assess the quality of life in patients with chronic pancreatitis, the majority of whom have had the disease for a long time, and to evaluate which factors linked to the disease are able to influence the quality of life. SUBJECTS AND METHODS: A total of 190 consecutive patients (157 males, 33 females; mean age 58.6+/-12.7 years, range 18-92 years) with proven chronic pancreatitis were enrolled. The SF-36 questionnaire was used for assessing the health-related quality of life. RESULTS: The z-scores of the eight domains of the patients with chronic pancreatitis were significantly negative indicating an overall impairment of the quality of life when compared to the Italian normative sample. Pancreatic pain was the unique clinical variable able to significantly impair all eight domains of the SF-36, while Wirsung dilation and diabetes were negatively related to some physical and mental domains. The body mass index was the unique variable positively related with some SF-36 domains. CONCLUSIONS: Pain may be considered the most important factor affecting the quality of life of chronic pancreatitis patients; moreover, alimentary and metabolic factors deserve more attention in improving the quality of life of these subjects.     

Stent insertion or endoluminal brachytherapy as palliation of patients with advanced cancer of the esophagus and gastroesophageal junction. Results of a randomized, controlled clinical trial

SUMMARY: Esophageal cancer often presents as advanced stage disease with a dismal prognosis, with only 10-15% of patients surviving 5 years. Therefore, in a large proportion of patients, palliative treatment is the only option available. The aim of this study was to prospectively compare the palliative effect of self-expandable stent placement with that of endoluminal brachytherapy regarding the effect on quality of life and on specific symptoms. Sixty-five patients with advanced cancer of the esophagus or gastroesophageal junction were randomized to treatment with either an Ultraflex expandable stent or high-dose-rate endoluminal brachytherapy with 7 Gy x 3 given in 2-4 weeks. Clinical assessment and health-related quality of life (HRQL) were measured at inclusion and 1, 3, 6, 9 and 12 months later. The HRQL was measured with standardized questionnaires (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30, European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Oesophageal Module and Hospital Anxiety and Depression Scale). Twenty-eight patients completed the stent treatment and 24 patients the brachytherapy. The group of patients treated with stent reported significantly better HRQL scores for dysphagia (P < 0.05) at the 1-month follow-up, but most other HRQL scores, including functioning and symptom scales, deteriorated. Among brachytherapy-treated patients, improvement was found for the dysphagia-related scores at the 3-months follow-up, whereas other significant changes of scores were few. The median survival time was comparable in the two groups (around 120 days). In conclusion, insertion of self-expandable metal stents offered a more instant relief of dysphagia compared to endoluminal brachytherapy, but HRQL was more stable in the brachytherapy group.     

Relationship between the magnitude of symptoms and the quality of life: a cluster analysis of lung cancer patients in Brazil

OBJECTIVE:

Lung cancer patients often experience profound physical and psychosocial changes as a result of disease progression or treatment side effects. Fatigue, pain, dyspnea, depression, and sleep disturbances appear to be the most common symptoms in such patients. The objective of the present study was to examine the prevalence of symptoms in lung cancer patients in order to identify subgroups (clusters) of patients, grouped according to the magnitude of the symptoms, as well as to compare the quality of life among the identified subgroups.

METHODS:

A cross-sectional study involving agglomerative hierarchical clustering. A total of 50 lung cancer patients were evaluated in terms of their demographic characteristics and their scores on three quality of life questionnaires, namely the 30-item European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30), the Functional Assessment of Cancer Therapy-Lung, and the Medical Outcomes Study 36-item Short-form Survey. The cluster analysis took into account the magnitude of the most prevalent symptoms as assessed by the EORTC QLQ-C30 symptom scale scores; those symptoms were fatigue, pain, dyspnea, and insomnia.

RESULTS:

Three clusters (subgroups)_of patients were identified on the basis of the magnitude of the four most prevalent symptoms. The three subgroups of patients were as follows: patients with mild symptoms (n = 30; 60%); patients with moderate symptoms (n = 14; 28%); and patients with severe symptoms (n = 6; 12%). The subgroup of patients with severe symptoms had the worst quality of life, as assessed by the total scores and by the integrated domains of all three instruments.

CONCLUSIONS:

This study highlights the importance of symptom cluster assessment as an important tool to assess the quality of life of patients with chronic diseases, such as lung cancer.     

Evaluation of Patient-Reported Outcome in Subjects Treated Medically for Acute Pancreatitis: A Follow-Up Study

Aims: To explore the quality of life in patients treated medically during the acute phase of pancreatitis as well as at 2 and 12 months after discharge from the hospital. Patients: 40 patients were studied. The etiology of the pancreatitis was biliary causes in 31 patients and non-biliary causes in 9; mild disease was present in 29 patients and severe disease in 11. 30 patients completed the two surveys at 2 and 12 months after hospital discharge. Methods: The SF-12 and EORTC QLQ-C30 questionnaires were used for the purpose of the study. Results: The two physical and mental component summaries of SF-12, all the domains of EORTC QLQ-C30 (except for physical functioning and cognitive functioning) and some symptom scales of EORTC QLQ-C30 (fatigue, nausea/ vomiting, pain, and constipation) were significantly impaired during the acute phase of pancreatitis. There was a significant improvement in the SF-12 physical component summary, and global health, role functioning, social functioning, nausea/vomiting, pain, dyspnea, and financial difficulties (EORTC QLQ-C30) at 2 months after discharge as compared to the basal evaluation. Similar results were found after 12 months except for the mental component score at 12-month evaluation, which was significantly impaired in acute pancreatitis patients in comparison to the norms. The physical functioning of the EORTC QLQ-C30 at basal evaluation was significantly impaired in patients with severe pancreatitis in comparison to patients with mild pancreatitis. Conclusions: Two different patterns can be recognized in the quality of life of patients with acute pancreatitis: physical impairment is immediately present followed by mental impairment which appears progressively in the follow-up period.     

Measurement of quality of life in carcinoid/neuroendocrine tumours

Quality of life is multi-dimensional, including issues relating to symptoms from the disease but also social, emotional, functional and financial domains. Debate remains on the true definition of quality of life and its measurement. Quality of life measurements are best done by patients themselves, although, in some situations a proxy such as carer or relative can be substituted. Healthcare workers can over- or underestimate overall quality of life. Currently used devices for measuring quality of life in cancer include the European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30, which is a generic tool for all cancers and which requires the use of add-on modules for specific cancers. We are developing a separate module for carcinoid/neuroendocrine tumours, in accordance with the EORTC guidelines on module development, which will be translated into five languages and will be available for use throughout Europe.     

Quality of life of patients with chronic lymphocytic leukemia: results of a longitudinal investigation over 1 yr

OBJECTIVES: The aim of this longitudinal study was to determine the long-term quality of life (QoL) of patients with chronic lymphocytic leukemia (CLL) and to investigate the relationship between QoL and sociodemographic and clinical parameters. METHODS: Ninety-seven patients suffering from CLL were asked to complete the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) four times over a period of 1 yr. Clinical data on disease and treatment characteristics were collected from medical records. For the purpose of comparison, EORTC QLQ-C30 scores were collected from 152 age- and gender-matched healthy controls. RESULTS: Seventy-six patients (age: median 68 yr, range 41-89) returned one or more questionnaires and were included in the statistical analysis. Compared with healthy controls CLL patients reported a lower QoL in almost all domains. No differences regarding QoL could be observed between CLL patients who had already received chemotherapy and those who had not. Moreover, female CLL patients were found to have remarkably lower QoL scores in the areas of emotional and social functioning than male patients. CONCLUSION: Patients suffering from CLL could have their QoL improved by more effective symptom management and psycho-oncological support. This could focus on specific symptoms such as fatigue and might have particular benefits for female patients with respect to their emotional and social well-being.     

A comparison of pancreaticoduodenectomy and duodenum-preserving head resection for the treatment of chronic pancreatitis

Background:

For chronic pancreatitis, European prospective trials have concluded that duodenum-preserving head resections (DPHR) are associated with less morbidity and similar pain relief and quality of life (QoL) outcomes compared with pancreaticoduodenectomy (PD). However, DPHR procedures are seldom performed in North America.

Methods:

Patients undergoing PD or DPHR for unremitting pain secondary to chronic pancreatitis were retrospectively identified. Quality of life was assessed cross-sectionally using the European Organization for Research and Treatment of Cancer (EORTC) Quality-of-Life Questionnaire (QLQ-C30) and pancreatic cancer-specific supplemental module (QLQ-PAN26).

Results:

Eighty-one patients underwent either a Whipple PD (n= 59) or a DPHR (Bern, Beger or Frey procedure, n= 22) for the treatment of pain caused by chronic pancreatitis over a 5-year period. The characteristics of patients undergoing DPHR and PD procedures were similar. Duration of procedure (360 min vs. 245 min), duration of hospital stay (12.0 days vs. 9.5 days) and estimated blood loss (535 ml vs. 214 ml) were all significantly less for DPHR patients (P < 0.05). Thirty-day morbidity and mortality, postoperative pain relief and QoL scores did not differ significantly between groups.

Conclusions:

Duodenum-preserving head resection is equally as effective as PD in relieving pain and improving QoL in chronic pancreatitis patients, and involves a shorter hospital stay and less blood loss.     

Quality of life and use of red cell transfusion in patients with myelodysplastic syndromes. A systematic review

The main treatment for many patients with Myelodysplastic Syndromes (MDS) remains red cell transfusion to attenuate the symptoms of chronic anemia. Fatigue can reduce a patient's health related quality of life (HRQoL), but there is little understanding of the optimal use of transfusions to improve this. A systematic review was performed to identify and appraise publications reporting the use of HRQoL instruments in patients with MDS. A total of 17 separate studies were identified that used 14 HRQoL instruments, but only one MDS disease specific HRQoL instrument (QOL‐E) was reported. Two well established HRQoL instruments were most often used in MDS research (variants of the Functional Assessment of Cancer Therapy (FACT) and the European Organisation for Research and Treatment of Cancer Core Quality of Life Questionnaire (QLQ‐C30)). Several common problems were identified in the published literature including a lack of power calculations to detect clinically relevant changes, small sample sizes and significant attrition rates for completion of HRQoL assessments, all of which limit the strength of any conclusions. There is no consensus on the optimal transfusion regimen to improve HRQoL in transfusion‐dependent MDS. Future research into HRQoL within MDS is a pressing requirement. Studies should focus on the domains that are of most clinical importance to the patient as well as traditional quantitative changes of hemoglobin concentration. Am. J. Hematol., 2009. © 2009 Wiley‐Liss, Inc.     

Quality of life measurement in patients with oesophageal cancer.

Quality of life (QOL) measurement may aid decision making in the treatment of patients with oesophageal cancer but must be clinically valid to be useful. This study considered if the European Organisation for Research and Treatment of Cancer QOL questionnaire, the QLQ-C30, showed differing results in two clinically distinct groups of patients with oesophageal cancer and also investigated the correlation between dysphagia grade and various scales of QOL. Patients treated by oesophagectomy reported significantly better physical, emotional, cognitive, and global health scores than those in the palliative treatment group. Patients who received palliative treatment had significantly worse pain, fatigue, appetite loss, constipation, and dysphagia. The correlations between dysphagia grade and each of the QOL scales and items in both groups of patients were poor. This questionnaire differentiates clearly between the two clinically distinct groups of patients, but to be an entirely appropriate indicator of QOL in patients with oesophageal cancer, an additional specific oesophageal module including a dysphagia scale is required.     

SF-36 and the development of new assessment tools for quality of life

The use of assessment tools for quality of life has allowed the incorporation of the views of patients in health decision-making. This article presents the characteristics and changes experienced by one of the most used questionnaires of quality of life at present the Short Form 36-item Health Survey SF-36 . We also discuss the issues related to the construction properties and applications of this measuring tool and other derived measures as the SF-12 the SF-8 the Dynamic Health Assessment DYNHA and the SF-6D. We emphasize the use of the SF-36 for assessing the effectiveness of interventions in health the SF-12 for the tracking of health disorders the SF-8 for the monitoring of population health the DYNHA for individualized evaluations in clinical practice and the SF-6D for economic analysis in health. Information on the versions validated for Portuguese language and the permission to use the questionnaires are provided.     

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.     

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.