Protocol: Quality of Life, Decision Making, Costs and Impact on Carers in People Managed without Dialysis - The PACKS Study

Patient-reported quality-of-life analysis of radium-223 dichloride from the phase III ALSYMPCA study

BACKGROUND: Radium-223 dichloride (radium-223), a first-in-class α-emitting radiopharmaceutical, is recommended in both pre- and post-docetaxel settings in patients with castration-resistant prostate cancer (CRPC) and symptomatic bone metastases based on overall survival benefit demonstrated in the phase III ALSYMPCA study. ALSYMPCA included prospective measurements of health-related quality of life (QOL) using two validated instruments: the general EuroQoL 5D (EQ-5D) and the disease-specific Functional Assessment of Cancer Therapy-Prostate (FACT-P).

PATIENTS AND METHODS: Analyses were conducted to determine treatment effects of radium-223 plus standard of care (SOC) versus placebo plus SOC on QOL using FACT-P and EQ-5D. Outcomes assessed were percentage of patients experiencing improvement, percentage of patients experiencing worsening, and mean QOL scores during the study.

RESULTS: Analyses were carried out on the intent-to-treat population of patients randomized to receive radium-223 (n = 614) or placebo (n = 307). The mean baseline EQ-5D utility and FACT-P total scores were similar between treatment groups. A significantly higher percentage of patients receiving radium-223 experienced meaningful improvement in EQ-5D utility score on treatment versus placebo {29.2% versus 18.5%, respectively; P = 0.004; odds ratio (OR) = 1.82 [95% confidence interval (CI) 1.21-2.74]}. Findings were similar for FACT-P total score [24.6% versus 16.1%, respectively; P = 0.020; OR = 1.70 (95% CI 1.08-2.65)]. A lower percentage of patients receiving radium-223 experienced meaningful worsening versus placebo measured by EQ-5D utility score and FACT-P total score. Prior docetaxel use and current bisphosphonate use did not affect these findings. Treatment was a significant predictor of EQ-5D utility score, with radium-223 associated with higher scores versus placebo (0.56 versus 0.50, respectively; P = 0.002). Findings were similar for FACT-P total score (99.08 versus 95.22, respectively; P = 0.004).

CONCLUSIONS: QOL data from ALSYMPCA demonstrated that improved survival with radium-223 is accompanied by significant QOL benefits, including a higher percentage of patients with meaningful QOL improvement and a slower decline in QOL over time in patients with CRPC.

Visual functioning and health-related quality of life in diabetic patients about to undergo anti-vascular endothelial growth factor treatment for sight-threatening macular edema

Purpose To examine patient-reported outcome (PRO) in a selected group of Swedish patients about to receive anti-vascular endothelial growth factor (VEGF) treatment for diabetic macular edema (DME). Material and methods In this cross-sectional study, 59 patients with diabetes mellitus, who regularly visited the outpatient eye-clinics, were included. Sociodemographic and clinical data were collected and the patients completed PRO measures before starting anti-VEGF treatment. PRO measures assessed eye-specific outcomes (NEI-VFQ-25) and generic health-related quality of life (SF-36). Results The participants consisted of 30 men and 29 women (mean age, 68.5 years); 54 (92 %) patients had type 2 diabetes; Five (9%) patients had moderate or severe visual impairment; 28 (47 %) were classified as having mild visual impairment. Some of the patients reported overall problems in their daily lives, such as with social relationships, as well as problems with impaired sight as a result of reduced distance vision. Conclusions Further studies are needed to investigate PRO factors related to low perceived general health in this patient population. It is important to increase our understanding of such underlying mechanisms to promote improvements in the quality of patient care.

Parental reports of the oral health-related quality of life of children with cerebral palsy

BACKGROUND The severity of physical and mental impairments and oral problems, as well as socioeconomic factors, may have an impact on quality of life of children with cerebral palsy (CP). The aim of this research was to assess the impact of impairments and oral health conditions, adjusted by socioeconomic factors, on the Oral Health-Related Quality of Life (OHRQoL) of children with CP using their parents as proxies. METHODS Sixty children, between 6-14 years of age were selected. Their parents answered a children's OHRQoL instrument (5 domains) which combines the Parental-Caregivers Perception Questionnaire (P-CPQ) and Family Impact Scale (FIS). The severity of dental caries, type of CP, communication ability, gross motor function, seizures and socioeconomic conditions were assessed. RESULTS Considering the total score of the OHRQoL instrument, only the reduction of communication ability and dental caries severity had a negative impact on the OHRQoL (p < 0.05). Considering each domain of the instrument, the severity of the type of CP and its reduction of communication ability showed a negative impact on oral symptoms and functional limitations domains (p < 0.05). Seizures have a negative impact on oral symptoms domain (p = 0.006). The multivariate fitted model showed that the severity of dental caries, communication ability and low family income were negatively associated with the impact on OHRQoL (p = 0.001). CONCLUSIONS The severity of dental caries, communication ability, and family income are conditions strongly associated with a negative impact on OHRQoL of children with CP.

A cross-sectional study assessing the association between online ratings and structural and quality of care measures : results from two German physician rating websites

BACKGROUND: Even though physician rating websites (PRWs) have been gaining in importance in both practice and research, little evidence is available on the association of patients' online ratings with the quality of care of physicians. It thus remains unclear whether patients should rely on these ratings when selecting a physician. The objective of this study was to measure the association between online ratings and structural and quality of care measures for 65 physician practices from the German Integrated Health Care Network "Quality and Efficiency" (QuE). METHODS: Online reviews from two German PRWs were included which covered a three-year period (2011 to 2013) and included 1179 and 991 ratings, respectively. Information for 65 QuE practices was obtained for the year 2012 and included 21 measures related to structural information (N = 6), process quality (N = 10), intermediate outcomes (N = 2), patient satisfaction (N = 1), and costs (N = 2). The Spearman rank coefficient of correlation was applied to measure the association between ratings and practice-related information. RESULTS: Patient satisfaction results from offline surveys and the patients per doctor ratio in a practice were shown to be significantly associated with online ratings on both PRWs. For one PRW, additional significant associations could be shown between online ratings and cost-related measures for medication, preventative examinations, and one diabetes type 2-related intermediate outcome measure. There again, results from the second PRW showed significant associations with the age of the physicians and the number of patients per practice, four process-related quality measures for diabetes type 2 and asthma, and one cost-related measure for medication. CONCLUSIONS: Several significant associations were found which varied between the PRWs. Patients interested in the satisfaction of other patients with a physician might select a physician on the basis of online ratings. Even though our results indicate associations with some diabetes and asthma measures, but not with coronary heart disease measures, there is still insufficient evidence to draw strong conclusions. The limited number of practices in our study may have weakened our findings.

Adaptation of the MacNew quality of life questionnaire after myocardial infarction in an Iranian population

BACKGROUND: Health-related quality of life (HRQL) assessment is an important measure of the impact of a wide range of disease process on an individual. To date, no HRQL tool has been evaluated in an Iranian population with cardiovascular disorders, specifically myocardial infarction, a major cause of mortality and morbidity. The MacNew Heart Disease Health-related Quality of Life instrument is a disease-specific HRQL questionnaire with satisfactory validity and reliability when applied cross-culturally. METHOD: A Persian version of MacNew was prepared by both forward and backward translation by bilinguals after which a feasibility test was performed. Consecutive patients (n = 51) admitted to a coronary care unit with acute myocardial infarction were recruited for measurement of their HRQL with retest one month after discharge in the follow-up clinic. Principal components analysis, intra-class correlation reliability, internal consistency, and test-retest reliability were assessed. RESULTS: Trivial rates of missing data confirmed the acceptability of the tool. Principal component analysis revealed that the three domains, emotional, social and physical, performed as well as in the original studies. Internal consistency was high and comparable to other studies, ranging from 0.92 for the emotional and physical domains, to 0.94 for the social domain, and to 0.95 for the Global score. Domain means of 5, 5.3 and 4.9 for emotional, physical and social respectively indicate that our Iranian population has similar emotional and physical but worse social HRQL scores. Test-retest analysis showed significant correlation in emotional and physical domains (P < 0.05). CONCLUSION: The Persian version of the MacNew questionnaire is comparable to the English version. It has high internal consistency and reasonable reproducibility, making it an appropriate specific quality of life tool for population-based studies and clinical practice in Iran in patients who have survived an acute myocardial infraction. Further studies are needed to confirm its validity in larger populations with cardiovascular disease

Health-related quality of life: implications for critical care interventional studies and why we need to collaborate with patients.

Purpose of review: Health-related quality of life (HRQoL) is an important patient-reported outcome measure following critical illness. ‘Validated’ and professionally endorsed generic measures are widely used to evaluate critical care intervention and guide practice, policy and research. Although recognizing that they are ‘here to stay’, leading QoL researchers are beginning to question their ‘fitness for purpose’. It is therefore timely to review critiques of their limitations in the wider healthcare and social science literatures and to examine the implications for critical care research including, in particular, emerging interventional studies in which HRQoL is the primary outcome of interest. Recent findings: Generic HRQoL measures have provided important yet limited insights into HRQoL among survivors of critical illness. They are rarely developed or validated in collaboration with patients and cannot therefore be assumed to reflect their experiences and perspectives. Summary: Collaboration with patients is advocated in order to improve the interpretation and utility of such data. Failure to do so may result in important study effects being overlooked and the dismissal of potentially useful interventions.

Effect of Aging in the Perception of Health-Related Quality of Life in End-Stage Renal Disease Patients under Online-Hemodiafiltration

This work aimed to evaluate how aging could influence patients' perception of health quality of life (HRQOL), as well as, the effect of aging on dialysis adequacy and in hematological, iron status, inflammatory and nutritional markers. In this transversal study were enrolled 305 ESRD patients under online-hemodiafiltration (OL-HDF) (59.67% males; 64.9 ± 14.3 years old). Data about comorbidities, hematological data, iron status, dialysis adequacy, nutritional and inflammatory markers were collected from patient's records. Moreover, HRQOL score, by using the Kidney Disease Quality of Life-Short Form (KDQOL-SF), was assessed. Analyzing the results according to quartiles of age, significant differences were found for some parameters evaluated by the KDQOL-SF instrument, namely for work status, physical functioning and role-physical, which decreased with increasing age. We also found a higher proportion of diabetic patients, a decrease in creatinine, iron, albumin serum levels, transferrin saturation and nPCR, with increasing age. Moreover, significant negative correlations were found between age and mean cell hemoglobin concentration, iron, transferrin saturation, albumin, nPCR, work status, physical functioning and role-physical. In conclusion, our results showed that aging is associated with a decreased work status, physical functioning and role-physical, with a decreased dialysis adequacy, iron availability and nutritional status, and with an increased proportion of diabetic patients and of patients using central venous catheter, as the vascular access. The knowledge of these changes associated with aging, which have impact in the quality of life of the patients, could be useful in their management.

Chronic respiratory diseases and quality of life in elderly nursing home residents

Few studies have assessed the quality of life (QOL) related to chronic respiratory diseases in the elderly. In the framework of the geriatric study on the health effects of air quality in elderly care centers (GERIA) study, a questionnaire was completed by elderly subjects from 53 selected nursing homes. It included various sections in order to assess respiratory complaints, QOL (World Health Organization QOL (WHOQOL)-BREF), and the cognitive and depression status. The outcome variables were the presence of a score lower than 50 (<50) in each of the WHOQOL-BREF domains (physical health, psychological health, social relationships, and environmental health). Chronic bronchitis, frequent cough, current wheezing, asthma, and allergic rhinitis were considered as potential risk factors. The surveyed sample was (n = 887) 79% female, with a mean age of 84 years (SD: 7 years). In the multivariable analysis, a score of <50 in the physical domain was associated with wheezing in the previous 12 months (odds ratio (OR): 2.03, confidence interval (CI): 1.25-3.31) and asthma (OR: 1.95, CI: 1.12-3.38). The psychological domain was related with a frequent cough (OR: 1.43, CI: 0.95-2.91). A score of <50 in the environmental domain was associated with chronic bronchitis (OR: 2.89, CI: 1.34-6.23) and emphysema (OR: 3.89, CI: 1.27-11.88). In view of these findings, the presence of respiratory diseases seems to be an important risk factor for a low QOL among elderly nursing home residents.

The Role of decision-analytic modelling in German health technology assessments

BACKGROUND: Decision-analytic modelling (DAM) has become a widespread method in health technology assessments (HTA), but the extent to which modelling is used differs among international HTA institutions. In Germany, the use of DAM is optional within HTAs of the German Institute of Medical Documentation and Information (DIMDI). Our study examines the use of DAM in DIMDI HTA reports and its effect on the quality of information provided for health policies. METHODS: A review of all DIMDI HTA reports (from 1998 to September 2012) incorporating an economic assessment was performed. All included reports were divided into two groups: HTAs with DAM and HTAs without DAM. In both groups, reports were categorized according to the quality of information provided for healthcare decision making. RESULTS: Of the sample of 107 DIMDI HTA reports, 17 (15.9%) used DAM for economic assessment. In the group without DAM, conclusions were limited by the quality of economic information in 51.1% of the reports, whereas we did not find limited conclusions in the group with DAM. Furthermore, 24 reports without DAM (26.7%) stated that using DAM would likely improve the quality of information of the economic assessment. CONCLUSION: The use of DAM techniques can improve the quality of HTAs in Germany. When, after a systematic review of existing literature within a HTA, it is clear that DAM is likely to positively affect the quality of the economic assessment DAM should be used.

Different Multimorbidity Measures Result in Varying Estimated Levels of Physical Quality of Life in Individuals with Multimorbidity: A Cross-Sectional Study in the General Population

International audience

The quality of care of diabetic patients in rural Malawi: A case of Mangochi district

Background Diabetes mellitus is a global public health problem. In Malawi, the prevalence of diabetes is 5.6% but the quality of care has not been well studied. Objective The aim of this study was to assess the quality of care offered to diabetic patients in Mangochi district. Methods This was a cross sectional descriptive study. Quantitative data were collected using a questionnaire from a sample of 75 diabetic patients (children and adults) who attended the Diabetes Clinic at Mangochi District Hospital between 20012 and 2013. Qualitative data were also collected using semi-structured interviews with eight Key Informants from among the District Health Management Team. Frequencies and cross-tabulation were obtained from the quantitative data. Patients’ master cards were checked to validate results. Clinical knowledge about diabetes, care practices and resources were the themes analysed from the qualitative data. Results Among the 75 participants interviewed, 46 were females and 29 males. The overall mean age was 48.3 years (45.6 for females and 53.3 for males). More than half of patients had little or no information about diabetes (40.0 % (n=30) and 22.7 (n=17) respectively. The majority of patients were taking their medicines regularly 98.7% (n=74). Only 17.3% (n=13) reported having their feet inspected regularly. Fifty-six percent of patients were satisfied about services provision. Some nurses and clinicians were trained on diabetes care but most of them left. Guidelines on diabetes management were not accessible. There were shortages in medicines (e.g. soluble insulin) and reagents. Information Education and Communication messages were offered through discussions, experiences sharing and posters. Conclusion Quality of diabetes care provided to diabetic patients attended to Mangochi hospital was sub-optimal due to lack of knowledge among patients and clinicians and resources. More efforts are needed towards retention of trained staff, provision of pharmaceutical and laboratory resources and health education.

Quality of life after first-ever stroke: An interviewbased study from Blantyre, Malawi

Background In post-stroke patients, impairment of quality of life (QOL) has been associated with functional impairment, age, anxiety, depression, and fatigue. Good social support, higher education, and better socioeconomic status are associated with better QOL among stroke survivors. In Africa, studies from Nigeria and Tanzania have reported on post-stroke QOL. Aim The aim of this study was to describe QOL more than six months after first-ever stroke in Malawi. Methods This was an interview-based study about a stroke-surviving cohort. Adult patients were interviewed six or twelve months after their first ever stroke. HIV status, modified stroke severity scale (mNIHSS) score, and brain scan results were recorded during the acute phase of stroke. At the time of the interviews, the modified Rankin scale (mRS) was used to assess functional outcome. The interviews applied the Newcastle Stroke-specific Quality of Life Measure (NEWSQOL). All the data were analysed using Statview™: the X2 test compared proportions, Student’s t-test compared means for normally distributed data, and the Kruskal-Wallis test was used for nonparametric data. Results Eighty-one patients were followed up at least six months after the acute stroke. Twenty-five stroke patients (ten women) were interviewed with the NEWSQOL questionnaire. Good functional outcome (lower mRS score) was positively associated with better QOL in the domains of activities of daily living (ADL)/self-care (p = 0.0024) and communication (p = 0.031). Women scored worse in the fatigue (p = 0.0081) and cognition (p = 0.048) domains. Older age was associated with worse QOL in the ADL (p = 0.0122) domain. Seven patients were HIV-seroreactive. HIV infection did not affect post-stroke QOL. Conclusion In Malawi, within specific domains, QOL after stroke appeared to be related to patients’ age, sex, and functional recovery in this small sample of patients.

Environmental quality of life index incorporationg MCA & GIS : case study Lisbon Metropolitan Area, Portugal

The study of Quality of Life (Qol) has been conducted on various scales throughout the years with focus on assessing overall quality of living amongst citizens. The main focus in these studies have been on economic factors, with the purpose of creating a Quality of Life Index (QLI).When it comes down to narrowing the focus to the environment and factors like Urban Green Spaces (UGS) and air quality the topic gets more focused on pointing out how each alternative meets this certain criteria. With the benefits of UGS and a healthy environment in focus a new Environmental Quality of Life Index (EQLI) will be proposed by incorporating Multi Criteria Analysis (MCA) and Geographical Information Systems (GIS). Working with MCA on complex environmental problems and incorporating it with GIS is a challenging but rewarding task, and has proven to be an efficient approach among environmental scientists. Background information on three MCA methods will be shown: Analytical Hierarchy Process (AHP), Regime Analysis and PROMETHEE. A survey based on a previous study conducted on the status of UGS within European cities was sent to 18 municipalities in the study area. The survey consists of evaluating the current status of UGS as well as planning and management of UGS with in municipalities for the purpose of getting criteria material for the selected MCA method. The current situation of UGS is assessed with use of GIS software and change detection is done on a 10 year period using NDVI index for comparison purposes to one of the criteria in the MCA. To add to the criteria, interpolation of nitrogen dioxide levels was performed with ordinary kriging and the results transformed into indicator values. The final outcome is an EQLI map with indicators of environmentally attractive municipalities with ranking based on predefinedMCA criteria using PROMETHEE I pairwise comparison and PROMETHEE II complete ranking of alternatives. The proposed methodology is applied to Lisbon’s Metropolitan Area, Portugal.

Oral health quality of the workers of a telemarketing company and their satisfaction with the treatments provided by the corporative dental insurance plan

Aim: To evaluate the oral health quality of the workers of a telemarketing company and their satisfaction with the dental treatments provided by the corporative dental insurance plan. Methods: Data collection was by an online intranet questionnaire on dental service providers from Uberlândia/MG and Campinas/SP. It was addressed to 6000 associates, with objective and subjective questions, comprising the level of the telemarketing operators’ oral health, dental needs, satisfaction with dental care providers and the importance of having the laboral dental services provided by the company. Results: After analysis of the results, we observed that: 57.52% of the workers required improvement in their oral health and 56.03% mentioned prevention as the largest need, 66.70% use the dental providers’ services, but only 31.34% were satisfied with them. Conclusions: The results underscore that the workers have an intermediate level of dental needs, with prevention as top importance. Additionally, establishment of a basic attention program inside the company would increase the satisfaction and adhesion indexes of providers and the workers’ oral health.