The EORTC Core Quality of Life questionnaire (QLQ-C30): validity and reliability when analysed with patients treated with palliative radiotherapy

The EORTC Core Quality of Life questionnaire (EORTC QLQ-C30) is designed to measure cancer patients' physical, psychological and social functions. The questionnaire is composed of multi-item scales and single items. 247 patients completed the EORTC QLQ-C30 before palliative radiotherapy and 181 after palliative radiotherapy. The questionnaire was well accepted with a high completion rate in the present patient population consisting of advanced cancer patients with short life expectancy. In addition, the questionnaire was found to be useful to detect the effect of palliative radiotherapy over time. The scale reliability was excellent for all scales except the role functioning scale. Excellent criterion validity was found for the emotional functioning scale where it was correlated with GHQ-20. Performance of the questionnaire was improved after the second evaluation as compared with the first. The present study shows that the EORTC QLQ-C30 is found to be practical and valid in measuring quality of life in patients with advanced disease.     

Assessment of the risk/benefit ratio of phase II cancer clinical trials by Institutional Review Board (IRB) members.

BACKGROUND: This study examined the assessment of risk/benefit ratios for phase II cancer clinical trials by Institutional Review Board (IRB) members. PATIENTS AND METHODS: Semi-structured interviews were conducted with 53 IRB members from six research hospitals and specialized cancer centers in The Netherlands. RESULTS: While the toxicity and side-effects of treatment were most often identified as risks associated with participating in a phase II trial, approximately two-thirds of IRB members also cited psychosocial and/or quality-of-life risks. Conversely, 68% of the respondents identified psychosocial benefits of trial participation, while 25% cited treatment effectiveness as a possible benefit. Between one-quarter and two-thirds of respondents indicated that trial protocols provide insufficient information regarding the likelihood, magnitude and duration of both risks and benefits. Between 15% and 34% of IRB members reported feeling less than fully competent at evaluating various aspects of phase II protocols (e.g. originality and feasibility of the study, adequacy of the methods and analysis procedures, etc.). This was particularly the case for non-physician IRB members. Few IRB members reported weighing risks and benefits in a systematic manner, but rather relied on global impressions or preferred to leave such matters to the IRB as a whole or to their patients. CONCLUSIONS: A substantial minority of IRB members believes that trial protocols provide too little information relevant to evaluating various cost/benefit and scientific issues, and feels less than fully competent in carrying out such evaluations. IRB members are more likely to identify psychosocial benefits than physical health benefits that may accrue to patients participating in phase II trials.     

Comparison of patient and spouse assessments of health related quality of life in men with metastatic prostate cancer

PURPOSE: We examined the extent of agreement in health related quality of life ratings provided by patients with metastatic prostate cancer and their spouses. This agreement is important for determining the feasibility of using spouses as potential proxy raters in quality of life studies in this patient population. MATERIALS AND METHODS: The study sample consisted of 72 pairs of patients with metastatic prostate cancer in remission or progression and their spouses. Patients and spouses independently completed the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 and a prostate cancer specific questionnaire module. Together the 2 questionnaires assess a wide range of symptoms and functional limitations for a total of 21 quality of life outcomes. RESULTS: For 5 of the 21 patient-proxy comparisons we noted systematic differences in the mean score with spouses rating more impairment in patients than patients indicated. Most patient-proxy correlations were 0.40 to 0.75, indicating moderate to good agreement in patient and spouse ratings. A low patient-proxy correlation of less than 0.40 was noted only for the 2 measures of sexual function. CONCLUSIONS: Our findings suggest that the spouses of men with metastatic prostate cancer evaluate with a fair degree of accuracy how patients experience physical and psychosocial functioning, symptoms and overall quality of life. However, caution should be exercised when relying on proxy raters for assessing sexual functioning and satisfaction.     

Feasibility, psychometric performance, and stability across modes of administration of the CARES-SF

BACKGROUND:: The primary objective was to investigate the validity and reliabilityof the Cancer Rehabilitation Evaluation System-Short Form (theCARES-SF) as a quality of life instrument in clinical trials[10]. PATIENTS AND METHODS:: A heterogeneous sample of 485 cancer patients completed theCARES-SF before treatment (T1), one month later (T2), and threemonths following T2 (T3). At T3 the patients completed the questionnaireeither by mail, in a telephone interview, or in the clinic.A sub sample of patients completed the CARES-SF a fourth time(T4) one week following T3, for purposes of test-retest reliabilityestimation. RESULTS:: On average, the CARES-SF required 11 minutes for completionand could be completed by 90% of the patients without assistance.However, 82% of the patients re ported difficulty with at leastone item. Multitrait scaling analysis and factor analysis generallyconfirmed the hypothe-sized scale structure. Internal consistencyreliability coefficients exceeded the 0.70 criterion for fourof six multi-item scales. The test-retest reliability coefficientsof the six scales were above 0.70. No systematic differenceswere found in the psychometrics of the CARES-SF across administrationconditions. In the mail condition the proportion of missingitems was significantly higher, and patients reported havingsignificantly more problems than in both the telephone and in-clinic condition. According to expectation, selective scalesdistinguished clearly between patients differing in diseasestage, performance status, treatment modality and tumor response.Additionally, selective scales were responsive to changes inhealth status over time. CONCLUSION:: These results lend support to the reliability and validity ofthe CARES-SF in assessing the quality of life of patients withcancer. At the same time, efforts to refine the questionnaireare recommended. Cancer, CARES-SF, quality of life, validation     

Quality of life in hospice patients with terminal illness

To better understand quality of life (QOL) and its important correlates among patients with terminal illness, a cross-sectional correlational design was used in a study based on Stewart, Teno, Patrick, and Lynn's conceptual model of factors affecting QOL of dying patients and their families. Sixty participants were recruited from two local hospice programs in the midwestern region of the United States. Data were collected at the participants' homes. The participants had an above average QOL. Living with the caregiver, spirituality, pain intensity, physical performance status, and social support as a set explained 38% of the variance in their QOL. Among these five predictors, living with the caregiver, spirituality, and social support statistically were significant predictors of the QOL of these participants. Participants who did not live with their caregivers experienced less pain intensity, perceived higher spirituality, had more social support, and had a significantly better QOL. Important contributions of these findings are discussed.     

Interaction study between digoxin and a preparation of hawthorn (Crataegus oxyacantha)

Hawthorn, an herbal supplement, is currently being evaluated for the treatment of heart failure. The flavonoid components of hawthorn may be responsible for hawthorn's beneficial effects in the treatment of heart failure. However, these components may also affect P-glycoprotein function and cause interactions with drugs that are P-glycoprotein substrates, such as digoxin, which is also used to treat heart failure. Therefore, the purpose of this study was to determine the effect of hawthorn on digoxin pharmacokinetic parameters. A randomized, crossover trial with 8 healthy volunteers was performed evaluating digoxin 0.25 mg alone (D) for 10 days and digoxin 0.25 mg with Crataegus special extract WS 1442 (hawthorn leaves with flowers; Dr. Willmar Schwabe Pharmaceuticals) 450 mg twice daily (D + H) for 21 days. Pharmacokinetic studies were performed for 72 hours. There were no statistically significant differences in any measured pharmacokinetic parameters. The AUC0-infinity, Cmax-Cmin, Cmin, and renal clearance for the D group were 79 +/- 26 mcg.h/L, 1.4 +/- 0.7 mcg/L, 0.84 +/- 0.2 mcg/L, and 74 +/- 10 mL/min versus 73 +/- 20 mcg.h/L, 1.1 +/- 0.1 mcg/L, 0.65 +/- 0.2 mcg/L, and 81 +/- 22 mL/min for the D + H group, respectively (p > 0.05). Following 3 weeks of concomitant therapy, hawthorn did not significantly alter the pharmacokinetic parameters for digoxin. This suggests that both hawthorn and digoxin, in the doses and dosage form studied, may be coadministered safely.     

The patient-physician relationship. Patient-physician communication during outpatient palliative treatment visits: an observational study

Context  Improving health-related quality of life (HRQL) is an important goal of palliative treatment, but little is known about actual patient-physician communication regarding HRQL topics during palliative treatment. Objectives  To investigate the content of routine communication regarding 4 specific HRQL issues between oncologists and their patients and to identify patient-, physician-, and visit-specific factors significantly associated with discussion of such issues. Design  Observational study conducted between June 1996 and January 1998. Setting  Outpatient palliative chemotherapy clinic of a cancer hospital in the Netherlands. Participants  Ten oncologists and 240 of their patients (72% female; mean age, 55 years) who had incurable cancer and were receiving outpatient palliative chemotherapy. Main Outcome Measures  Patient and physician questionnaires and audiotape analysis of communication regarding daily activities, emotional functioning, pain, and fatigue during an outpatient consultation using the Roter Interaction Analysis System. Results  Physicians devoted 64% of their conversation to medical/technical issues and 23% to HRQL issues. Patients' communication behavior was divided more equally between medical/technical issues (41%) and HRQL topics (48%). Of the independent variables investigated, patients' self-reported HRQL was the most powerful predictor of discussing HRQL issues. Nevertheless, in 20% to 54% of the consultations in which patients were experiencing serious HRQL problems, no time was devoted to discussion of those problems. In particular, these patients' emotional functioning and fatigue were unaddressed 54% and 48% of the time, respectively. Discussion of HRQL issues was not more frequent in consultations in which tumor response was evaluated. Conclusion  Despite increasing recognition of the importance of maintaining patients' HRQL as a goal of palliative treatment, the amount of patient-physician communication devoted to such issues remains limited and appears to make only a modest contribution, at least in an explicit sense, to the evaluation of treatment efficacy in daily clinical practice.      

半夏泻心汤及其拆方对幽门螺杆菌相关性胃炎小鼠血清炎性相关因子的影响

目的:探讨半夏泻心汤治疗幽门螺杆菌感染所致胃黏膜炎症的内在机制。方法:用幽门螺杆菌菌液给小鼠灌胃造模,然后随机分成10组,分别给予相应的药物治疗。观察各组小鼠胃黏膜的形态学改变及血清中NO和IL-8含量的变化。结果:模型组小鼠血清中NO、IL-8水平较空白组显著升高(P<0·01),各治疗组NO、IL-8水平均有不同程度的降低,其中以半夏泻心汤组、苦寒组、半夏加苦寒组、苦寒加甘温组降低最为显著,与模型组比较差异具有显著性意义(P<0·01)。结论:半夏泻心汤通过降低血清中NO、IL-8的含量而减轻胃黏膜的炎症反应,从而发挥其对胃黏膜的保护作用。     

Molecular cloning and physical characterization of integrated equine infectious anemia virus: molecular and immunologic evidence of its close relationship to ovine and caprine lentiviruses

Molecular clones of the integrated form of the genome of equine infectious anemia virus (EIAV), the etiologic agent of a naturally occurring, worldwide disease of horses, were obtained. The restriction map of a full-length genome was determined. Additional evidence for the close evolutionary relationship between EIAV and a prototype lentivirus (caprine arthritis encephalitis virus) was acquired by Southern blotting and immunological analyses. An interspecies radioimmunoassay was developed in which EIAV and ovine and caprine lentiviruses could be detected equally well. These studies make available precisely defined reagents to pursue the study of the mechanisms of pathogenesis of lentiviral induced diseases.