Exploring patient-reported outcomes following percutaneous coronary intervention: A qualitative study.

BACKGROUND: Percutaneous coronary intervention (PCI) is a common cardiac procedure used to treat obstructive coronary artery disease. Patient-centred care is a priority in cardiovascular health having been shown to increase patient satisfaction, engagement with rehabilitation activities and reduce anxiety. Evidence indicates that patient-centred care is best achieved by routine collection of patient-reported outcomes (PROs). However, existing patient-reported outcome measures (PROMs) have limited the patient involvement in their development. AIMS: To identify and explore outcomes, patients perceive as important following PCI. METHODS: A qualitative design was adopted. Eight focus groups and five semi-structured interviews were conducted with 32 patients who had undergone PCI in the previous 6 months. Outcomes were identified and mapped under the U.S. Food and Drug Administration (FDA) patient-reported outcome (PROs) domains of feeling (physical and psychological outcomes), function and evaluation. Inductive and deductive analysis methods were used with open, axial and thematic coding. RESULTS: Consistent with prior studies, patients identified feeling and function outcomes such as reductions in physical and psychological symptoms and the ability to perform usual activities as important. Participants also identified a range of new outcomes, including confidence to return to usual activities and evaluation domains such as adverse effects of medications and the importance of patient communication. CONCLUSION: The findings of this research should be considered in the design of a cardiac PROM for PCI patients. A PROM which adequately assesses these outcomes can provide clinicians and hospital staff with a foundation in which to address these concerns or symptoms.

New-Onset Diabetes After Statin Exposure in Elderly Women: The Australian Longitudinal Study on Women's Health.

INTRODUCTION: Extensive clinical research has consistently shown statins lower the risk of cardiovascular events and mortality. Some studies also suggest statins increase the risk of new-onset diabetes. Research to date has rarely included elderly women, hence little is known about the risk of diabetes after statin exposure in this population. OBJECTIVES: Our objectives were to evaluate and estimate the risk of new-onset diabetes associated with statin exposure in a cohort of elderly Australian women. METHODS: We performed an analysis of a population-based longitudinal cohort study with data linkage to the national death index and to national databases of non-hospital episodes of medical care and prescription medications dispensing. Participants included 8372 Australian women born between 1921 and 1926, alive at 1 January 2003, free of diabetes, and eligible for data linkage. Statin exposure was ascertained based on prescriptions dispensed between 1 July 2002 and 31 August 2013. RESULTS: Over 10 years of follow up, 49% of the cohort had filled a prescription for statins and 5% had initiated treatment for new-onset diabetes. Multivariable Cox regression showed statin exposure was associated with a higher risk of treatment for new-onset diabetes (hazard ratio 1.33; 95% confidence interval [CI] 1.04-1.70; p = 0.024). This equates to a number needed to harm (NNH) of 131 (95% CI 62-1079) for 5 years of exposure to statins. Risk increased with increasing dose of statin from the hazard ratio of 1.17 (95% CI 0.84-1.65) for the lowest dose to 1.51 (95% CI 1.14-1.99) for the highest dose. CONCLUSION: The dose-response for statins on new onset of diabetes suggests elderly women should not be exposed to higher doses of statins. Elderly women currently taking statins should be carefully and regularly monitored for increased blood glucose to ensure early detection and appropriate management of this potential adverse effect, including consideration of de-prescribing.

Determinants of physical activity in a cohort of young adult women. Who is at risk of inactive behaviour?

OBJECTIVES: To identify the biological, socio-demographic, work-related and lifestyle determinants of physical activity in young adult women. DESIGN: Prospective cohort study. METHODS: Self-reported data from 11,695 participants (aged 22-27 years in 2000) in the Australian Longitudinal Study on Women's Health were collected over 9 years in 2000, 2003, 2006 and 2009. Generalised Estimating Equations were used to examine univariable and multivariable associations of body mass index, country of birth, area of residence, education, marital status, number of children, occupational status, working hours, smoking, alcohol intake, and stress with physical activity status (active, ≥600 MET·min/week; or inactive, <600 MET·min/week, consistent with public health guidelines). RESULTS: All variables were significantly associated with physical activity in univariable models. In the multivariable model, the lowest odds of being active (compared with the relevant reference categories) were for women who: were born in Asia (OR=0.53), had less than 12 years of education (OR=0.79), were married (OR=0.66) or in a de facto relationship (OR=0.79), had at least one child (OR ranging from 0.67 to 0.69), and were classified as non (OR=0.66) or rare drinkers (OR=0.79). CONCLUSIONS: These results are among the first to confirm the biological, socio-demographic, work-related and lifestyle determinants of physical activity in women in their twenties and early thirties. These findings may be used to inform and improve the development of strategies, and to identify target groups most in need of intervention effort.

Effects of self-reported osteoarthritis on physical performance: a longitudinal study with a 10-year follow-up.

BACKGROUND AND AIMS: Osteoarthritis (OA) of the knee or hip is associated with limitations in activities of daily life. There are only a few long-term studies on how knee or hip OA affects the course of physical performance. The aim of this study was to investigate the effects of knee or hip OA on physical performance during a follow-up period of 10 years. METHODS: Participants in the Longitudinal Aging Study Amsterdam with self-reported hip or knee OA (N = 155) were prospectively followed for 10 years on 4 occasions from the onset of OA and compared to participants without OA (N = 1004). Physical performance was tested with walk, chair stand and balance tests. Scores for each test were summed to a total performance score (range 0-12), higher scores indicating better performance. Generalized estimating equations were used to analyze differences between participants with and without OA, unadjusted as well as adjusted for confounders. RESULTS: There was a significant interaction between OA and sex (P = 0.068). Both in men and women, total performance was lower for participants with OA, with greater differences in men. Chair stand and walking performance (P < 0.05), but not balance, were lower in participants with OA. After adjustment for confounders, these associations remained significant in men but not in women. Additional analyses correcting for follow-up duration and attrition showed lower performance scores for men and women with OA. CONCLUSIONS: OA negatively affected physical performance 3-6 years after it was first reported. Performance in men with OA was more affected than in women.

Prevention of fall incidents in patients with a high risk of falling: design of a randomised controlled trial with an economic evaluation of the effect of multidisciplinary transmural care.

BACKGROUND: Annually, about 30% of the persons of 65 years and older falls at least once and 15% falls at least twice. Falls often result in serious injuries, such as fractures. Therefore, the prevention of accidental falls is necessary. The aim is to describe the design of a study that evaluates the efficacy and cost-effectiveness of a multidisciplinary assessment and treatment of multiple fall risk factors in independently living older persons with a high risk of falling. METHODS/DESIGN: The study is designed as a randomised controlled trial (RCT) with an economic evaluation. Independently living persons of 65 years and older who recently experienced a fall are interviewed in their homes and screened for risk of recurrent falling using a validated fall risk profile. Persons at low risk of recurrent falling are excluded from the RCT. Persons who have a high risk of recurrent falling are blindly randomised into an intervention (n = 100) or usual care (n = 100) group. The intervention consists of a multidisciplinary assessment and treatment of multifactorial fall risk factors. The transmural multidisciplinary approach entails close cooperation between geriatrician, primary care physician, physical therapist and occupational therapist and can be extended with other specialists if relevant. A fall calendar is used to record falls during one year of follow-up. Primary outcomes are time to first and second falls. Three, six and twelve months after the home visit, questionnaires for economic evaluation are completed. After one year, during a second home visit, the secondary outcome measures are reassessed and the adherence to the interventions is evaluated. Data will be analysed according to the intention-to-treat principle and also an on-treatment analysis will be performed. DISCUSSION: Strengths of this study are the selection of persons at high risk of recurrent falling followed by a multidisciplinary intervention, its transmural character and the evaluation of adherence. If proven effective, implementation of our multidisciplinary assessment followed by treatment of fall risk factors will reduce the incidence of falls. TRIAL REGISTRATION: Current Controlled Trials ISRCTN11546541.