Comparison of the EQ-5D-3L and the SF-6D (SF-12) contemporaneous utility scores in patients with cardiovascular disease.

PURPOSE: Multi-attribute utility instruments (MAUIs) are widely used to measure utility weights. This study sought to compare utility weights of two popular MAUIs, the EQ-5D-3L and the SF-6D, and inform researchers in the selection of generic MAUI for use with cardiovascular (CVD) patients. METHODS: Data were collected in the Young@Heart study, a randomised controlled trial of a nurse-led multidisciplinary home-based intervention compared to standard usual care. Participants (n = 598) completed the EQ-5D-3L and the SF-12v2, from which the SF-6D can be constructed, at baseline and at 24-month follow-up. This study examined discrimination, responsiveness, correlation and differences across the two instruments. RESULTS: Both MAUIs were able to discriminate between the NYHA severity classes and recorded similar changes between the two time points although only SF-6D differences were significant. Correlations between the dimensions of the two MAUIs were low. There were significant differences between the two instruments in mild conditions but they were similar in severe conditions. Substantial ceiling and floor effects were observed. CONCLUSIONS: Our findings indicate that the EQ-5D and the SF-6D cover different spaces in health due to their classification systems. Both measures were capable of discriminating between severity groups and responsive to quality of life changes in the follow-up. It is recommended to use the EQ-5D-3L in severe and the SF-6D in mild CVD conditions.

The Mental Health in Diabetes Service (MINDS) to enhance psychosocial health: study protocol for a randomized controlled trial.

BACKGROUND: After a diagnosis of diabetes mellitus, people not only have to cope with the physical aspects and common complications that require daily self-management, they are also faced with ongoing psychosocial challenges. Subsequently they find themselves having to navigate the health system to engage multidisciplinary supports; the combination of these factors often resulting in reduced health-related quality of life. To maintain optimal diabetes control, interventions need to incorporate psychosocial supports and a skill base for disease management. Therefore, our aim was to evaluate an 'Optimal Health Program' that adopts a person-centred approach and engages collaborative therapy to educate and support the psychosocial health of people diagnosed with type I or II diabetes. METHODS: This prospective randomised controlled trial will include 166 people diagnosed with diabetes: 83 in the intervention (Optimal Health Program) and 83 in the control (usual care) group. Participants with type diabetes mellitus will be recruited through hospital outpatient clinics and diabetes community organisations. Participants in the intervention group will receive nine (8 + 1 booster session) sequential sessions, based on a structured treatment manual emphasising educational and psychosocial support self-efficacy and skills building. The primary outcome measures will be generalised self-efficacy (GSE) and health-related quality of life (AQoL-6D and EQ-5D). Secondary measures will be anxiety and depression (HADS), social and workplace functioning (WSAS), diabetes-related quality of life (DQoL), diabetes-related distress (PAID), and type of coping strategies (Brief COPE). In addition, a health economic cost analysis and process evaluations will be performed to assess the economic cost and efficacy of the program's operations, implementation and service delivery. DISCUSSION: We envisage that the Optimal Health Program's emphasis on self-efficacy and self-management will provide participants with the skills and knowledge to achieve increased empowerment and independence in aspects of health, which in turn, will help participants deal more effectively with the physical and psychosocial complexities of diabetes. TRIAL REGISTRATION: ACTRN12614001085662 . Registered on 10 October 2014.

Design and protocol for the Dialysis Optimal Health Program (DOHP) randomised controlled trial.

BACKGROUND: Chronic kidney disease (CKD) and end-stage kidney disease (ESKD) are serious and growing health problems with enormous impact on psychological and social functioning. Despite high rates of comorbid depression and anxiety in these patient populations, and the adverse impact these have upon treatment adherence, quality of life, social connectedness and healthcare costs there has been little attention focused on the prevention or management of these problems. Thus, our aim was to evaluate the Dialysis Optimal Health Program (DOHP) that adopts a person-centred approach and engages collaborative therapy to educate and support those diagnosed with ESKD who are commencing dialysis. METHODS: The study design is a randomised controlled trial. Ninety-six adult patients initiating haemodialysis or peritoneal dialysis will be randomly allocated to either the intervention (DOHP) or usual care group. Participants receiving the intervention will receive nine (8 + 1 booster session) sequential sessions based on a structured information/workbook, psychosocial and educational supports and skills building. The primary outcome measures are depression and anxiety (assessed by the Hospital Anxiety and Depression Scale; HADS). Secondary outcomes include health-related quality of life (assessed by the Kidney Disease Quality of Life instrument; KDQOL), self-efficacy (assessed by General Self-Efficacy Scale) and clinical indices (e.g. albumin and haemoglobin levels). Cost-effectiveness analysis and process evaluation will also be performed to assess the economic value and efficacy of the DOHP. Primary and secondary measures will be collected at baseline and at 3-, 6-, and 12-month follow-up time points. DISCUSSION: We believe that this innovative trial will enhance knowledge of interventions aimed at supporting patients in the process of starting dialysis, and will broaden the focus from physical symptoms to include psychosocial factors such as depression, anxiety, self-efficacy, wellbeing and community support. The outcomes associated with this study are significant in terms of enhancing an at-risk population's psychosocial health and reducing treatment-related costs and associated pressures on the healthcare system. TRIAL REGISTRATION: ANZCTR no. 12615000810516 . Registered on 5 August 2015.

The Stroke and Carer Optimal Health Program (SCOHP) to enhance psychosocial health: study protocol for a randomized controlled trial.

BACKGROUND: Stroke is a leading cause of disability and distress, and often profoundly affects the quality of life of stroke survivors and their carers. With the support of carers, many stroke survivors are returning to live in the community despite the presence of disability and ongoing challenges. The sudden and catastrophic changes caused by stroke affects the mental, emotional and social health of both stroke survivors and carers. The aim of this study is to evaluate a Stroke and Carer Optimal Health Program (SCOHP) that adopts a person-centred approach and engages collaborative therapy to educate, support and improve the psychosocial health of stroke survivors and their carers. METHODS: This study is a prospective randomised controlled trial. It will include a total of 168 stroke survivors and carers randomly allocated into an intervention group (SCOHP) or a control group (usual care). Participants randomised to the intervention group will receive nine (8 + 1 booster) sessions guided by a structured workbook. The primary outcome measures for stroke survivors and carers will be health-related quality of life (AQoL-6D and EQ-5D) and self-efficacy (GSE). Secondary outcome measures will include: anxiety and depression (HADS); coping (Brief COPE); work and social adjustment (WSAS); carer strain (MCSI); carer satisfaction (CASI); and treatment evaluation (TEI-SF and CEQ). Process evaluation and a health economic cost analysis will also be conducted. DISCUSSION: We believe that this is an innovative intervention that engages the stroke survivor and carer and will be significant in improving the psychosocial health, increasing independence and reducing treatment-related costs in this vulnerable patient-carer dyad. In addition, we expect that the intervention will assist carers and stroke survivors to negotiate the complexity of health services across the trajectory of care and provide practical skills to improve self-management. TRIAL REGISTRATION: ACTRN12615001046594 . Registered on 7 October 2015.

Trialling of an optimal health programme (OHP) across chronic disease.

Population ageing is a worldwide phenomenon, most advanced in developed countries and expected to continue over the next few decades. As people are surviving longer with age-associated disease and disability, there is an imperative to identify innovative solutions for an already overburdened health care system. Such innovations need to be focused on disease management, taking into consideration the strong associations that have been established between psychosocial factors and pathophysiological mechanisms associated with chronic disease. Aside from personal and community costs, chronic diseases produce a significant economic burden due to the culmination of health care costs and lost productivity. This commentary reports on a programme of research, Translating Research, Integrated Public Health Outcomes and Delivery, which will evaluate an optimal health programme that adopts a person-centred approach and engages collaborative therapy to educate, support and improve the psychosocial health of those with chronic disease. The effectiveness of the optimal health programme will be evaluated across three of the most significant contributors to disease burden: diabetes mellitus, chronic kidney disease and stroke. Cost-effectiveness will also be evaluated. The findings derived from this series of randomised controlled trials will also provide evidence attesting to the potential applicability of the optimal health programme in other chronic conditions.

Improving access and equity in reducing cardiovascular risk: the Queensland Health model.

OBJECTIVES: To measure changes in cardiovascular risk factors among patients with coronary heart disease (CHD) and/or type 2 diabetes enrolled in a centralised statewide coaching program delivered by telephone and mail-out in the public health sector in Queensland. DESIGN: A population-based audit of cardiovascular risk factor data collected prospectively as part of The COACH (Coaching Patients On Achieving Cardiovascular Health) Program (TCP) delivered through Queensland Health's Health Contact Centre. SETTING AND PARTICIPANTS: 1962 patients with CHD and 707 patients with type 2 diabetes who completed TCP from 20 February 2009 to 20 June 2013, of whom 145 were Indigenous Australians. MAIN OUTCOME MEASURES: Changes in fasting lipids, fasting glucose, glycosylated haemoglobin levels, blood pressure, body weight, body mass index, smoking, alcohol consumption and physical activity, as measured at entry to and completion of the program. RESULTS: Statistically significant improvements in cardiovascular risk factor status, from entry to completion of the program, were found across all biomedical and lifestyle factors in patients with CHD and/or type 2 diabetes. For both diseases, improvements in serum lipids, blood glucose, smoking habit and alcohol consumption combined with increases in physical activity were the most notable findings. Similar differences were found in mean change scores in cardiovascular risk factors between Indigenous and non-Indigenous Queenslanders. CONCLUSION: A centralised statewide coaching program delivered by telephone and mail-out overcomes obstacles of distance and limited access to health services and facilitates a guideline-concordant decrease in cardiovascular risk.

Exploring health care providers' perceptions of the needs of stroke carers: informing development of an optimal health program.

BACKGROUND: Health care provider experiences of the carer have been researched, but little is written about how these can inform development of support programs. OBJECTIVES: This study aimed to (1) explore health care provider perceptions of stroke carer roles and support needs and (2) examine carer needs across the stroke care trajectory to assist with development of an Optimal Health Program (OHP) to support carers. This study is part of a staged program of research that will evaluate and refine the OHP. METHODS: Four dual-moderated semi-structured focus groups of stroke health care providers across acute, subacute, and community rehabilitation services were conducted. Facilitators used a semi-structured focus group schedule to guide discussion. Sessions were recorded, transcribed, and analyzed using thematic and content analysis. RESULTS: Three key themes emerged: transition, information, and impact of stroke. A number of subthemes highlighted the distinct roles of health care providers and carers. Specific elements of the OHP were identified as having the potential to advance support for carers across the stroke care trajectory. DISCUSSION: Findings support the integration of an OHP for carers within existing stroke care services in Australian public hospital and community settings. CONCLUSION: This study suggests how health care provider experiences could inform a self-management OHP to assist carers in navigating stroke services and to address their health-related concerns.

Screening for mild cognitive impairment in patients with heart failure: Montreal cognitive assessment versus mini mental state exam.

BACKGROUND: Cognitive impairments occur frequently in patients with chronic heart failure (CHF), resulting in worse health outcomes than expected. These impairments can remain undetected unless specifically screened. There are limited sensitive screening measures available in nursing practice to identify mild cognitive impairment (MCI). AIM: To compare the Montreal Cognitive Assessment (MoCA) with the Mini Mental State Exam (MMSE) in screening for MCI in CHF patients. METHODS: The MMSE and MoCA were administered to 93 hospitalized CHF patients (70±11 years), without a history of neurocognitive problems. Patients with low MoCA scores (<26) were compared to those with low MMSE scores (<27). Two different parameters were examined between the MoCA and the MMSE: level of MCI agreement (Kappa coefficient) and task errors on assessed cognitive domains (χ2 test). RESULTS: Statistically more patients had low MoCA scores compared with low MMSE scores (66 vs. 30, p=0.02). The MoCA classified 38 (41%) patients as cognitively impaired that were not classified by the MMSE. A significantly low level of agreement was found (κ=0.25, p=0.001) between the MMSE and MoCA in identifying patients with scores suggestive of MCI. More task errors were observed on the MoCA cognitive domains compared with the MMSE cognitive domains. In 68% of patients with low cognitive scores, visuospatial task errors were observed on tasks from the MoCA compared with 22% on a similar task of the MMSE. CONCLUSION: The MoCA, a screening tool for MCI, identified subtle but potentially clinically relevant cognitive dysfunctions with greater frequency than MMSE.

The Chinese version of the Myocardial Infarction Dimensional Assessment Scale (MIDAS): Mokken scaling.

BACKGROUND: Hierarchical scales are very useful in clinical practice due to their ability to discriminate precisely between individuals, and the original English version of the Myocardial Infarction Dimensional Assessment Scale has been shown to contain a hierarchy of items. The purpose of this study was to analyse a Mandarin Chinese translation of the Myocardial Infarction Dimensional Assessment Scale for a hierarchy of items according to the criteria of Mokken scaling. Data from 180 Chinese participants who completed the Chinese translation of the Myocardial Infarction Dimensional Assessment Scale were analysed using the Mokken Scaling Procedure and the 'R' statistical programme using the diagnostics available in these programmes. Correlation between Mandarin Chinese items and a Chinese translation of the Short Form (36) Health Survey was also analysed. FINDINGS: Fifteen items from the Mandarin Chinese Myocardial Infarction Dimensional Assessment Scale were retained in a strong and reliable Mokken scale; invariant item ordering was not evident and the Mokken scaled items of the Chinese Myocardial Infarction Dimensional Assessment Scale correlated with the Short Form (36) Health Survey. CONCLUSIONS: Items from the Mandarin Chinese Myocardial Infarction Dimensional Assessment Scale form a Mokken scale and this offers further insight into how the items of the Myocardial Infarction Dimensional Assessment Scale relate to the measurement of health-related quality of life people with a myocardial infarction.