The Relationship between Diabetes Mellitus and Health-Related Quality of Life in Korean Adults: The Fourth Korea National Health and Nutrition Examination Survey (2007-2009)

BackgroundDiabetes is a major health problem in Korea. However, interest in the quality of life in patients with diabetes is low. We examined the effects of diabetes on health-related quality of life (HRQoL) and compared it with HRQoL in the general Korean population using the Fourth Korea National Health and Nutrition Examination Survey (KNHANES IV) (2007-2009).MethodsUsing KNHANES IV data, we compared EuroQol (EQ)-5D and EQ-visual analogue scale (VAS) scores after adjusting for sociodemographic and psychosocial factors as well as for comorbidities (hypertension, heart disease, stroke, arthritis, and chronic renal disease). Logistic regressions were used to explore determinants for the lowest quintile HRQoL scales in the diabetes group.ResultsThe mean age of the 14,441 enrolled subjects (6,129 men and 8,312 women) was 52.5±14.5 years. The mean EQ-5D and EQ-VAS scores were significantly lower in the diabetes group (EQ-5D. 0.87; EQ-VAS, 71.94) than in the non-diabetes group (EQ-5D, 0.94; EQ-VAS, 77.40) (P<0.001). Self-reported depressive symptom had a significant effect on lowering the EQ-VAS (odds ratio [OR], 1.7; 95% confidence interval [CI], 1.1 to 2.6) in the diabetes group. Stress level had a significant effect in lowering both the EQ-5D (OR, 2.0; 95% CI, 1.3 to 2.9) and the EQ-VAS (OR, 1.9; 95% CI, 1.3 to 2.9). HbA1c, diabetes duration, and treatment modalities had no significant effect on lowering HRQoL.ConclusionDiabetes was clearly associated with impaired HRQoL compared with the non-diabetic population regardless of comorbidities. Therapeutic approaches should focus much more on the subjective perception of health in patients with diabetes

Reliability and validity of a self-administration version of DEMQOL-Proxy.

: This study aimed to investigate the reliability and validity of a self-administered version of DEMQOL-Proxy, a disease-specific instrument that measures health-related quality of life in people with dementia. : The sample consisted of 173 informal carers of people with dementia, aged 29 to 89 years old. Carers were mostly female, White/White British and closely related to the patient. They completed DEMQOL-Proxy (self-administered), EQ-5D-3L (proxy reported about the person with dementia), EQ-5D-3L (self-reported about their own health) and the Zarit Burden Interview. Using well-established methods from classical test theory, we evaluated scale level acceptability, reliability and convergent, discriminant and known-groups validity of DEMQOL-Proxy. : DEMQOL-Proxy (self-administered) showed high acceptability (3.5% missing data and 0% scores at floor or ceiling), high internal consistency reliability (α = 0.93) and good convergent and discriminant validity. Amongst others, we found a moderately high correlation with EQ-5D-3L proxy reported (r = 0.52) and low to essentially zero correlations with EQ-5D-3L self-reported (r = 0.20) and carer and patient background variables (r ≤ 0.20). As predicted, DEMQOL-Proxy (self-administered) showed a modest correlation with DEMQOL (r = 0.32). Known-groups differences on health-related quality of life (comparing people with versus people without cognitive impairment) were of moderate effect size (d = 0.38) and in the expected direction. : DEMQOL-Proxy (self-administered) has comparable acceptability, reliability and validity with DEMQOL-Proxy (interviewer administered). DEMQOL-Proxy (self-administered) can be used in a wider variety of contexts than its interviewer-administered version, including routine use in busy clinics. Copyright © 2016 John Wiley &amp; Sons, Ltd.<br/

Patient-reported outcomes from a phase III study of baricitinib in patients with conventional synthetic DMARD-refractory rheumatoid arthritis

Objectives: To evaluate the effect of baricitinib on patient-reported outcomes (PROs) in patients with active rheumatoid arthritis (RA) and an inadequate response or intolerance to conventional synthetic disease-modifying antirheumatic drugs. Methods: In this phase III study, patients were randomised 1:1:1 to placebo (N=228), baricitinib 2 mg once daily (QD, N=229) or baricitinib 4 mg QD (N=227). PROs included the Health Assessment Questionnaire-Disability Index (HAQ-DI), Patient's Global Assessment of Disease Activity (PtGA), patient's assessment of pain, measures from patient electronic daily diaries (duration and severity of morning joint stiffness (MJS), Worst Tiredness, Worst Joint Pain), Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F), SF-36, EuroQol 5-D index scores and visual analogue scales (VAS) and the Work Productivity and Activity Impairment Questionnaire-RA. The primary time point for the study was week 12. Treatment comparisons were assessed with logistic regression for categorical measures and analysis of covariance for continuous variables. Results: Statistically significant improvements were observed for both baricitinib groups versus placebo in HAQ-DI, PtGA, pain, daily diary measures, EuroQoL index scores and SF-36 physical component score at week 12 and for those measures when assessed at week 24. Baricitinib 2 mg and baricitinib 4 mg were statistically significantly improved versus placebo for the EuroQoL VAS and FACIT-F, respectively, at week 24. Conclusions: Baricitinib 2 or 4 mg provided significant improvement versus placebo in PROs across different domains of RA, including physical function, MJS, fatigue, pain and quality of life

Dutch translation and cross-cultural validation of the Adult Social Care Outcomes Toolkit (ASCOT)

Background: The Adult Social Care Outcomes Toolkit was developed to measure outcomes of social care in England. In this study, we translated the four level self-completion version (SCT-4) of the ASCOT for use in the Netherlands and performed a cross-cultural validation. Methods: The ASCOT SCT-4 was translated into Dutch following international guidelines, including two forward and back translations. The resulting version was pilot tested among frail older adults using think-aloud interviews. Furthermore, using a subsample of the Dutch ACT-study, we investigated test-retest reliability and construct validity and compared response distributions with data from a comparable English study. Results: The pilot tests showed that translated items were in general understood as intended, that most items were reliable, and that the response distributions of the Dutch translation and associations with other measures were comparable to the original English version. Based on the results of the pilot tests, some small modifications and a revision of the Dignity items were proposed for the final translation, which were approved by the ASCOT development team. The complete original English version and the final Dutch translation can be obtained after registration on the ASCOT website (http://www.pssru.ac.uk/ascot). Conclusions: This study provides preliminary evidence that the Dutch translation of the ASCOT is valid, reliable and comparable to the original English version. We recommend further research to confirm the validity of the modified Dutch ASCOT translation

The cost effectiveness of an early transition from hospital to nursing home for stroke patients: design of a comparative study

<p>Abstract</p> <p>Background</p> <p>As the incidence of stroke has increased, its impact on society has increased accordingly, while it continues to have a major impact on the individual. New strategies to further improve the quality, efficiency and logistics of stroke services are necessary. Early discharge from hospital to a nursing home with an adequate rehabilitation programme could help to optimise integrated care for stroke patients.</p> <p>The objective is to describe the design of a non-randomised comparative study evaluating early admission to a nursing home, with multidisciplinary assessment, for stroke patients. The study is comprised of an effect evaluation, an economic evaluation and a process evaluation.</p> <p>Methods/design</p> <p>The design involves a non-randomised comparative trial for two groups. Participants are followed for 6 months from the time of stroke. The intervention consists of a redesigned care pathway for stroke patients. In this care pathway, patients are discharged from hospital to a nursing home within 5 days, in comparison with 12 days in the usual situation. In the nursing home a structured assessment takes place, aimed at planning adequate rehabilitation. People in the control group receive the usual care. The main outcome measures of the effect evaluation are quality of life and daily functioning. In addition, an economic evaluation will be performed from a societal perspective. A process evaluation will be carried out to evaluate the feasibility of the intervention as well as the experiences and opinions of patients and professionals.</p> <p>Discussion</p> <p>The results of this study will provide information about the cost effectiveness of the intervention and its effects on clinical outcomes and quality of life. Relevant strengths and weaknesses of the study are addressed in this article.</p> <p>Trial registration</p> <p>Current Controlled Trails ISRCTN58135104</p

The impact of volunteering on the volunteer: findings from a peer support programme for family carers of people with dementia

With an ageing population, there are increasing numbers of experienced family carers (FCs) who could provide peer support to newer carers in a similar care situation. The aims of this paper are to: (i) use a cross-sectional study design to compare characteristics of volunteers and recipients of a peer support programme for FCs of people with dementia, in terms of demographic background, social networks and psychological well-being; and (ii) use a longitudinal study design to explore the overall impact of the programme on the volunteers in terms of psychological well-being. Data were collected from programmes run in Norfolk, Northamptonshire, Berkshire and four London boroughs between October 2009 and March 2013. The volunteer role entailed empathic listening and encouragement over a 10-month period. Both carer support volunteers (N = 87) and recipient FCs (N = 109) provided baseline demographic information. Data on social networks, personal growth, self-efficacy, service use and well-being (SF-12; EuroQol Visual Analogue Scale; Hospital Anxiety and Depression Scale; Control, Autonomy, Self-Realisation, Pleasure-19) were collected prior to the start of the intervention (N = 43) and at either 3- to 5 month or 10 month follow-up (N = 21). Volunteers were more likely than recipients of support to be female and to have cared for a parent/grandparent rather than spouse. Volunteers were also more psychologically well than support recipients in terms of personal growth, depression and perceived well-being. The longitudinal analysis identified small but significant declines in personal growth and autonomy and a positive correlation between the volunteers' duration of involvement and perceived well-being. These findings suggest that carers who volunteer for emotional support roles are resilient and are at little psychological risk from volunteering

Baseline observations from the POSSIBLE EU® study: characteristics of postmenopausal women receiving bone loss medications

Summary: Prospective Observational Scientific Study Investigating Bone Loss Experience in Europe (POSSIBLE EU®) is an ongoing longitudinal cohort study that utilises physician- and patient-reported measures to describe the characteristics and management of postmenopausal women on bone loss therapies. We report the study design and baseline characteristics of 3,402 women recruited from general practice across five European countries. Purpose The POSSIBLE EU® is a study describing the characteristics and management of postmenopausal women receiving bone loss medications. Methods: Between 2005 and 2008, general practitioners enrolled postmenopausal women initiating, switching or continuing treatment with bone loss treatment in France, Germany, Italy, Spain and the UK. Patients and physicians completed questionnaires at study entry and at 3-month intervals, for 1 year. Results: Of 3,402 women enrolled (mean age 68.2 years [SD] 9.83), 96% were diagnosed with low bone mass; 55% of these using dual energy X-ray absorptiometry. Most women (92%) had comorbidities. Mean minimum T score (hip or spine) at diagnosis was −2.7 (SD 0.89; median −2.7 [interquartile range, −3.2, −2.2]) indicating low bone mineral density. Almost 40% of the women had prior fractures in adulthood, mostly non-vertebral, non-hip in nature, 30% of whom had at least two fractures and more than half experienced moderate/severe pain or fatigue. Bisphosphonates were the most common type of bone loss treatment prescribed in the 12 months preceding the study. Conclusions POSSIBLE EU® characterises postmenopausal women with low bone mass, exhibiting a high rate of prevalent fracture, substantial bone fragility and overall comorbidity burden. Clinical strategies for managing osteoporosis in this population varied across the five participating European countries, reflecting their different guidelines, regulations and standards of care

Design of an internet-based health economic evaluation of a preventive group-intervention for children of parents with mental illness or substance use disorders

Background Preventive interventions are developed for children of parents with mental and substance use disorders (COPMI), because these children have a higher risk of developing a psychological or behavioral disorder in the future. Mental health and substance use disorders contribute significantly to the global burden of disease. Although the exact number of parents with a mental illness is unclear, the subject of mentally ill parents is gaining attention. Moreover there is a lack of interventions for COPMI-children, as well of (cost-) effectiveness studies evaluating COPMI interventions. Innovative interventions such as e-health provide a new field for exploration. There is no knowledge about the opportunities for using the internet to prevent problems in children at risk. In the current study we will focus on the (cost-) effectiveness of an online health prevention program for COPMI-children. Methods/Design We designed a randomized controlled trial to examine the (cost-) effectiveness of the Kopstoring intervention. Kopstoring is an online intervention for COPMI-children to strengthen their coping skills and prevent behavioral and psychological problems. We will compare the Kopstoring intervention with (waiting list) care as usual. This trial will be conducted entirely over the internet. An economic evaluation, from a societal perspective will be conducted, to examine the trial's cost-effectiveness. Power calculations show that 214 participants are needed, aged 16-25. Possible participants will be recruited via media announcements and banners on the internet. After screening and completing informed consent procedures, participants will be randomized. The main outcome is internalizing and externalizing symptoms as measured by the Youth Self Report. For the economic evaluation, healthcare costs and costs outside the healthcare sector will be measured at the same time as the clinical measures, at baseline, 3, 6 and 9 months. An extended measure for the intervention group will be provided at 12 months, to examine the long-term effects. In addition, a process evaluation will be conducted. Discussion Recent developments, such as international conferences and policy discussions, show the pressing need to study the (cost-) effectiveness of interventions for vulnerable groups of children. This study will shed light on the (cost-) effectiveness of an online preventive intervention