A new instrument to describe indicators of well-being in old-old patients with severe dementia – The Vienna List

BACKGROUND: In patients with very severe dementia self-rating of quality of life usually is not possible and appropriate instruments for proxy-ratings are not available. The aim of this project is to develop an instrument of clinical proxy-ratings for this population. METHODS: Using electronic instruments, physicians and nurses recorded patient behaviour and changes of behaviour over a period of one year. Based on these data a list of 65 items was generated and subsequently allocated to 14 categories. This list was tested in 217 patients (61–105 yrs) with dementia diagnosed according to ICD-10 by both physicians and nurses. The severity of dementia was assessed by means of the Global Deterioration Scale (GDS) and the Brief Cognitive Rating Scale (BCRS). The Spitzer-Index (proxy-rating) was used as a global quality of life measure. Activity of daily living was rated using the Barthel Index. RESULTS: A factor analysis of the original 65 items revealed 5 factors (communication, negative affect, bodily contact, aggression, and mobility). By stepwise removing items we obtained satisfactory internal consistencies of the factors both for nurses' and physicians' ratings. The factors were generally unrelated. The validity of the instrument was proven by correlations of the factors communication and mobility with the Brief Cognitive Rating Scale (BCRS) and the Barthel-Index. CONCLUSION: The results demonstrate the reliability and validity of the Vienna List as a proxy rating measurement of quality of life in patients with severe dementia. The psychometric properties of the scale have to be proved in further studies

Overcoming barriers to the implementation of patient-reported outcomes in cancer clinical trials : The PROMOTION Registry

Acknowledgments We acknowledge the essential contribution of all collaborators of the PROMOTION Registry. This project is funded by a research grant from the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Group. Also, additional support for the conduct of the study was provided by the Italian Group for Adult Hematologic Diseases (GIMEMA). JMB is supported by the MRC ConDuCT Hub for Trials Methodology Research. We also acknowledge Alessandro Perreca for his invaluable contribution in the data management.Peer reviewedPublisher PD

Patient-reported outcomes and final overall survival results from the randomized phase 3 PENELOPE trial evaluating pertuzumab in low tumor human epidermal growth factor receptor 3 (HER3) mRNA-expressing platinum-resistant ovarian cancer

Introduction: The PENELOPE trial evaluated pertuzumab added to chemotherapy for biomarker-selected platinum-resistant ovarian cancer. As previously reported, pertuzumab did not statistically significantly improve progression-free survival (primary end point: HR 0.74, 95% CI 0.50 to 1.11), although results in the paclitaxel and gemcitabine cohorts suggested activity. Here, we report final overall survival and patient-reported outcomes. Patients and methods: Eligible patients had ovarian carcinoma that progressed during/within 6 months of completing ≥4 platinum cycles, low tumor human epidermal growth factor receptor 3 (HER3) mRNA expression, and ≤2 prior chemotherapy lines. Investigators selected single-agent topotecan, gemcitabine or weekly paclitaxel before patients were randomized to either placebo or pertuzumab (840→420 mg every 3 weeks), stratified by selected chemotherapy, prior anti-angiogenic therapy, and platinum-free interval. Final overall survival analysis (key secondary end point) was pre-specified after 129 deaths. Patient-reported outcomes (secondary end point) were assessed at baseline and every 9 weeks until disease progression. Results: At database lock (June 9, 2016), 130 (83%) of 156 randomized patients had died. Median follow-up was 27 months in the pertuzumab arm versus 26 months in the control arm. In the intent-to-treat population there was no overall survival difference between treatment arms (stratified HR 0.90, 95% CI 0.61 to 1.32; p=0.60). Results in subgroups defined by stratification factors indicated heterogeneity similar to previous progression-free survival results. Updated safety was similar to previously published results. Compliance with patient-reported outcomes questionnaire completion was >75% for all validated patient-reported outcomes measures. Pertuzumab demonstrated neither beneficial nor detrimental effects on patient-reported outcomes compared with placebo, except for increased diarrhea symptoms. Discussion: Consistent with the primary results, adding pertuzumab to chemotherapy for low tumor HER3 mRNA-expressing platinum-resistant ovarian cancer did not improve overall survival, but showed trends in some cohorts. Except for increased diarrhea symptoms, pertuzumab had no impact on patient-reported outcomes. ClinicalTrials.gov: ClinicalTrials.gov: NCT01684878

International validation of the EORTC QLQ-PRT20 module for assessment of quality of life symptoms relating to radiation proctitis: A phase IV study

Background: Although patients experience radiation proctitis post radiotherapy no internationally tested instruments exist to measure these symptoms. This Phase IV study tested the scale structure, reliability and validity and cross-cultural applicability of the EORTC proctitis module (QLQ-PRT23) in patients who were receiving pelvic radiotherapy. Methods: Patients (n = 358) from six countries completed the EORTC QLQ-C30, QLQ-PRT23 and EORTC Quality of Life Group debriefing questions. Clinicians completed the EORTC Radiation Therapy Oncology Group scale. Questionnaires were completed at four time-points. The module’s scale structure was examined and validated using standard psychometric analysis techniques. Results: Three items were dropped from the module (QLQ-PRT23→QLQ-PRT20). Factor analysis identified five factors in the module: bowel control; bloating and gas; emotional function/lifestyle; pain; and leakage. Inter-item correlations were within r = 0.3–0.7. Test-Retest reliability was high. All multi-item scales discriminated between patients showing symptoms and those without symptomology. The module discriminated symptoms from the clinician completed scoring and for age, gender and comorbidities. Conclusion: The EORTC QLQ-PRT20 is designed to be used in addition to the EORTC QLQ-C30 to measure quality of life in patients who receive pelvic radiotherapy. The EORTC QLQ-PRT20 is quick to complete, acceptable to patients, has good content validity and high reliability. Trial registration: Australian and New Zealand Clinical Trials Registry (ANZCTR) ACTRN1260900097222

Health-related quality of life and subjective well-being : A cross-cultural perspective <Research Article>

Perspectives regarding the concept of health have changed from a pathogenic to a salutogenic model. The salutogenic approach considers different dimensions of well-being as determinants of health within individuals and societies. The relationship among health, subjective well-being, and the environment is broadly conceptualized within a transactional model of stress and coping, which recognizes the potential influence of the external environment on individual well-being. The salutogenic model stresses the strengths of individuals and their capacity for adjustment; it explains why certain people seem to preserve health and successfully cope with exposure to life stressors from their environment. Sense of coherence is a necessary condition for health and quality of life; it is an overall orientation for viewing the world and interacting with the environment in a comprehensive, manageable, meaningful way. A relationship among sense of coherence, health, and quality of life has been found in various clinical samples, general populations, children, and students. University attendance is regarded as a positive event that provides excellent opportunities for individual development; it represents a critical developmental period for young adults, in which students enter a new social environment, where they must adjust to new social norms and establish new relationships. This experience is also accompanied by multiple and significant changes, stress, and challenges in academic, social, and emotional areas. Sense of coherence is a health-promoting resource that can improve resilience, resulting in a positive state of subjective well-being and quality of life. Research in diverse cultural settings will improve our understanding of health outcomes and the extent in which these outcomes are individually, socially, or culturally determined. This is important toward establishing programs for health promotion and establishing health policies to meet the social and societal conditions in different countries

Bullying from a cross-cultural perspective : A comparison between Austria and Japan

This paper aims to compare the prevalence of bullying and victimization among students in Austria and Japan and to discuss cross-cultural differences based on the current research. Data from Japan were based on school reports from MEXT (2010) and from students' self-assessments (Morita, 1999). The Austrian data were primarily drawn from international surveys (HBSC data of 2006) and national studies (Gradinger et al., 2009 etc), and based mainly on self-reports from anonymous students. Overall, the results of this review showed some differences in the prevalence and types of bullying between the two countries. According to the student reports, bullying and victimization in elementary and lower secondary schools occurs at a higher rate in Austria than in Japan. This cross-cultural difference may partly be explained by the fact that Japanese students have a tendency not to report bullying as frequently as students in Western cultures. Regarding the type of bullying in both countries, verbal bullying was most common, but the rate of this type of bullying was much higher in Japan. However in the case of physical bullying, the rate in Austria is higher than in Japan.Social bullying in terms of "taking or hiding things from others" has been reported in both countries to a similar degree

Psychometric validation of the European Organisation for Research and Treatment of Cancer– Quality of Life Questionnaire Sexual Health (EORTC QLQ-SH22)

Background: The European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Group developed a questionnaire to assess sexual health in patients with cancer and cancer survivors. This study evaluates the psychometric properties of the questionnaire. Methods: The 22-item EORTC sexual health questionnaire (EORTC QLQ-SH22) was administered with the EORTC QLQ-C30 to 444 patients with cancer. The hypothesised scale structure, reliability and validity were evaluated through standardised psychometric procedures. Results: The cross-cultural field study showed that the majority of patients (94.7%) were able to complete the QLQ-SH22 in less than 20 min ; 89% of the study participants did not need any help to fill in the questionnaire. Multi-item multi-trait scaling analysis confirmed the hypothesised scale structure with two multi-item scales (sexual satisfaction, sexual pain) and 11 single items (including five conditional items and four gender- specific items). The internal consistency yielded acceptable Cronbach's alpha coefficients (.90 for the sexual satisfaction scale, .80 for the sexual pain scale). The test-retest correlations (Pearson's r) ranged from .70 to .93 except for the scale communication with professionals (.67) and male body image (.69). The QLQ-SH22 discriminates well between subgroups of patients differing in terms of their performance and treatment status. Conclusion: The study supports the reliability, the content and construct validity of the QLQ- SH22. The newly developed questionnaire is clinically applicable to assess sexual health of patients with cancer at different treatment stages and during survivorship for clinical trials and for clinical practice