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Background: Chronic kidney disease with metabolic acidosis is common in older people, but the effectiveness of oral sodium bicarbonate therapy in this group is unclear. We tested whether oral sodium bicarbonate provides net health benefit for older people with advanced chronic kidney disease and serum bicarbonate concentrations < 22 mmol/L.Methods: Pragmatic multicentre, parallel group, double-blind, placebo-controlled randomised trial. We recruited adults aged ≥ 60 years with estimated glomerular filtration rate of < 30 mL/min/1.73 m2, not receiving dialysis, with serum bicarbonate concentration < 22 mmol/L, from 27 nephrology and geriatric medicine departments in the UK. Participants received oral sodium bicarbonate (up to 3 g/day) or matching placebo given for up to 2 years, randomised in a 1:1 ratio. The primary outcome was between-group difference in the Short Physical Performance Battery (SPPB) at 12 months, adjusted for baseline values, analysed by intention to treat. Secondary outcomes included generic and disease-specific quality of life (EQ-5D and KDQoL tools), anthropometry, renal function, walk distance, blood pressure, bone and vascular health markers, and incremental cost per quality-adjusted life year gained.Results: We randomised 300 participants between May 2013 and February 2017, mean age 74 years, 86 (29%) female. At 12 months, 116/152 (76%) participants allocated to bicarbonate and 104/148 (70%) allocated to placebo were assessed; primary outcome data were available for 187 participants. We found no significant treatment effect for the SPPB: bicarbonate arm 8.3 (SD 2.5) points, placebo arm 8.8 (SD 2.2) and adjusted treatment effect - 0.4 (95% CI - 0.9 to 0.1, p = 0.15). We found no significant treatment effect for glomerular filtration rate (0.6 mL/min/1.73 m2, 95% CI - 0.8 to 2.0, p = 0.39). The bicarbonate arm showed higher costs and lower quality of life as measured by the EQ-5D-3L tool over 1 year (£564 [95% CI £88 to £1154]); placebo dominated bicarbonate under all sensitivity analyses. Adverse events were more frequent in those randomised to bicarbonate (457 versus 400).Conclusions: Oral sodium bicarbonate did not improve physical function or renal function, increased adverse events and is unlikely to be cost-effective for use by the UK NHS for this patient group.Trial Registration: European Clinical Trials Database (2011-005271-16) and ISRCTN09486651; registered 17 February 2012. [ABSTRACT FROM AUTHOR]

Objective: The aim of this study was to explore the feasibility of conducting a randomized controlled trial of dynamic Lycra® orthoses as an adjunct to arm rehabilitation after stroke and to explore the magnitude and direction of change on arm outcomes. Design: This is a single-blind, two-arm parallel group, feasibility randomized controlled trial. Setting: In-patient rehabilitation. Subjects: The study participants were stroke survivors with arm hemiparesis two to four weeks after stroke receiving in-patient rehabilitation. Interventions: Participants were randomized 2:1 to wear Lycra® gauntlets for eight hours daily for eight weeks, plus usual rehabilitation (n = 27), or to usual rehabilitation only (n = 16). Main measures: Recruitment, retention, fidelity, adverse events and completeness of data collection were examined at 8 and 16 weeks; arm function (activity limitation; Action Research Arm Test, Motor Activity Log) and impairment (Nine-hole Peg Test, Motricity Index, Modified Tardieu Scale). Structured interviews explored acceptability. Results: Of the target of 51, 43 (84%) participants were recruited. Retention at 8 weeks was 32 (79%) and 24 (56%) at 16 weeks. In total, 11 (52%) intervention group participants and 6 (50%) control group participants (odds ratio = 1.3, 95% confidence interval = 0.2 to 7.8) had improved Action Research Arm Test level by 8 weeks; at 16 weeks, this was 8 (61%) intervention and 6 (75.0%) control participants (odds ratio = 1.1, 95% confidence interval = 0.1 to 13.1). Change on other measures favoured control participants. Acceptability was influenced by 26 adverse reactions. Conclusion: Recruitment and retention were low, and adverse reactions were problematic. There were no indications of clinically relevant effects, but the small sample means definitive conclusions cannot be made. A definitive trial is not warranted without orthoses adaptation. [ABSTRACT FROM AUTHOR]

Background: Cross-sectional relationships between physical activity and health have been explored extensively, but less is known about how physical activity changes with time in older people. The aim of this study was to assess baseline predictors of how objectively measured physical activity changes with time in older people.Methods: Longitudinal cohort study using data from the Physical Activity Cohort Scotland. A sample of community-dwelling older people aged 65 and over were recruited in 2009-2011, then followed up 2-3 years later. Physical activity was measured using Stayhealthy RT3 accelerometers over 7 days. Other data collected included baseline comorbidity, health-related quality of life (SF-36), extended Theory of Planned Behaviour Questionnaire and Social Capital Module of the General Household Survey. Associations between follow-up accelerometer counts and baseline predictors were analysed using a series of linear regression models, adjusting for baseline activity levels and follow-up time.Results: Follow up data were available for 339 of the original 584 participants. The mean age was 77 years, 185 (55%) were female and mean follow up time was 26 months. Mean activity counts fell by between 2% per year (age < =80, deprivation decile 5-10) and 12% per year (age > 80, deprivation decile 5-10) from baseline values. In univariate analysis age, sex, deprivation decile, most SF-36 domains, most measures of social connectedness, most measures from the extended Theory of Planned Behaviour, hypertension, diabetes mellitus, chronic pain and depression score were significantly associated with adjusted activity counts at follow-up. In multivariate regression age, satisfactory friend network, SF-36 physical function score, and the presence of diabetes mellitus were independent predictors of activity counts at follow up after adjustment for baseline count and duration of follow up.Conclusions: Health status and social connectedness, but not extended Theory of Planned Behaviour measures, independently predicted changes in physical activity in community dwelling older people. [ABSTRACT FROM AUTHOR]

Background: Cardiovascular disease (CVD) is a common comorbidity in people with asthma. However, safety concerns have caused heterogeneity in clinical guideline recommendations over the use of cardioselective beta-blockers in people with asthma and CVD, partly because risk in the general population has been poorly quantified. The aim of this study was to measure the risk of asthma exacerbations with beta-blockers prescribed to a general population with asthma and CVD.Methods: Linked data from the UK Clinical Practice Research Datalink was used to perform nested case-control studies among people with asthma and CVD matched on age, sex and calendar time. Adjusted incidence rate ratios (IRR) were calculated for the association between oral beta-blocker use and moderate asthma exacerbations (rescue oral steroids) or severe asthma exacerbations (hospitalisation or death) using conditional logistic regression.Results: The cohort consisted of 35,502 people identified with active asthma and CVD, of which 14.1% and 1.2% were prescribed cardioselective and non-selective beta-blockers, respectively, during follow-up. Cardioselective beta-blocker use was not associated with a significantly increased risk of moderate or severe asthma exacerbations. Consistent results were obtained following sensitivity analyses and a self-controlled case series approach. In contrast, non-selective beta-blockers were associated with a significantly increased risk of moderate asthma exacerbations when initiated at low to moderate doses (IRR 5.16, 95% CI 1.83-14.54, P = 0.002), and both moderate and severe exacerbations when prescribed chronically at high dose (IRR 2.68, 95% CI 1.08-6.64, P = 0.033 and IRR 12.11, 95% CI 1.02-144.11, P = 0.048, respectively).Conclusions: Cardioselective beta-blockers prescribed to people with asthma and CVD were not associated with a significantly increased risk of moderate or severe asthma exacerbations and potentially could be used more widely when strongly indicated. [ABSTRACT FROM AUTHOR]

Objective: To determine whether spironolactone could benefit older people with osteoarthritis (OA), based on a previous study showing that spironolactone improved quality of life.Methods: This parallel-group, randomized, placebo-controlled, double-blind trial randomized community-dwelling people ages ≥70 years with symptomatic knee OA to 12 weeks of 25 mg daily oral spironolactone or matching placebo. The primary outcome was between-group difference in change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscale scores. Secondary outcomes included WOMAC stiffness and physical function subscores, EuroQol 5-domain (EQ-5D) 3L score, and mechanistic markers. Analysis was by intent to treat, using mixed-model regression, adjusting for baseline values of test variables.Results: A total of 421 people had eligibility assessed, and 86 were randomized. Mean ± SD age was 77 ± 5 years and 53 of 86 (62%) were women. Adherence to study medication was 99%, and all participants completed the 12-week assessment. No significant improvement was seen in the WOMAC pain score (adjusted treatment effect 0.5 points [95% confidence interval (95% CI) - 0.3, 1.3]; P = 0.19). No improvement was seen in WOMAC stiffness score (0.2 points [95% CI -0.6, 1.1]; P = 0.58), WOMAC physical function score (0.0 points [95% CI -0.7, 0.8]; P = 0.98), or EQ-5D 3L score (0.04 points [95% CI -0.04, 0.12]; P = 0.34). Cortisol, matrix metalloproteinase 3, and urinary C-telopeptide of type II collagen were not significantly different between groups. More minor adverse events were noted in the spironolactone group (47 versus 32), but no increase in death or hospitalization was evident.Conclusion: Spironolactone did not improve symptoms, physical function, or health-related quality of life in older people with knee OA. [ABSTRACT FROM AUTHOR]

Objective: to test the predictive utility of perceived barriers to objectively measured physical activity levels in a stratified sample of older adults when accounting for social-cognitive determinants proposed by the Theory of Planned Behaviour (TPB), and economic and demographic factors. Methods: data were analysed from the Physical Activity Cohort Scotland survey, a representative and stratified (65-80 and 80+ years; deprived and affluent) sample of 584 community-dwelling older people, resident in Tayside, Scotland. Physical activity was measured objectively by accelerometry. Results: perceived barriers clustered around the areas of poor health, lack of interest, lack of safety and lack of access. Perceived poor health and lack of interest, but not lack of access or concerns about personal safety, predicted physical activity after controlling for demographic, economic and TPB variables. Discussion: perceived person-related barriers (poor health and lack of interest) seem to be more strongly associated with physical activity levels than perceived environmental barriers (safety and access) in a large sample of older adults. Perceived barriers are modifiable and may be a target for future interventions. [ABSTRACT FROM AUTHOR]

Problem Antibiotic administration to inpatients developing sepsis in general hospital wards was frequently delayed. We aimed to reproduce improvements in sepsis management reported in other settings. Context Ninewells Hospital, an 860-bed teaching hospital with quality improvement (QI) experience, in Scotland, UK. The intervention wards were 22 medical, surgical and orthopaedic inpatient wards. Design A multifaceted intervention, informed by baseline process data and questionnaires and interviews with junior doctors, evaluated using segmented regression analysis of interrupted time series (ITS) data. Measures for improvement Primary outcome measure: antibiotic administration within 4 hours of sepsis onset. Secondary measures: antibiotics within 8 hours; mean and median time to antibiotics; medical review within 30 min for patients with a standardised early warning system score ≥4; blood cultures taken before antibiotic administration; blood lactate level measured. Strategies for change The intervention included printed and electronic clinical guidance, educational clinical team meetings including baseline performance data, audit and monthly feedback on performance. Effects of change Performance against all study outcome measures improved postintervention but differences were small and ITS analysis did not attribute the observed changes to the intervention. Lessons learnt Rigorous analysis of this carefully designed improvement intervention could not confirm significant effects. Statistical analysis of many such studies is inadequate, and there is insufficient reporting of negative studies. In light of recent evidence, involving senior clinical team members in verbal feedback and action planning may have made the intervention more effective. Our focus on rigorous intervention design and evaluation was at the expense of iterative refinement, which likely reduced the effect. This highlights the necessary, but challenging, requirement to invest in all three components for effective QI. [ABSTRACT FROM AUTHOR]

Background: Physical activity (PA) in older adults is influenced by a range of environmental, demographic, health-related, social, and psychological variables. Social cognitive psychological models assume that all influences on behaviour operate indirectly through the models constructs, i.e., via intention and self-efficacy. We evaluated direct, indirect, and moderating relationships of a broad range of external variables with physical activity levels alongside intention and self-efficacy. Methods: We performed a cross-sectional survey of a representative and stratified (65-80 and 80+ years; deprived and affluent) sample of 584 community-dwelling people, resident in Scotland. Objectively measured physical activity and questionnaire data were collected. Results: Self-efficacy showed unique relationships with physical activity, controlling for demographic, mental health, social, environmental, and weather variables separately, but the relationship was not significant when controlling for physical health. Overall, results indicating support for a mediation hypothesis, intention and self-efficacy statistically mediate the relationship of most domain variables with physical activity. Moderation analyses show that the relationship between social cognitions and physical activity was stronger for individuals with better physical health and lower levels of socio-economic deprivation. Conclusions: Social cognitive variables reflect a range of known environmental, demographic, health-related and social correlates of physical activity, they mediate the relationships of those correlates with physical activity and account for additional variance in physical activity when external correlates are controlled for, except for the physical health domain. The finding that the social cognition-physical activity relationship is higher for participants with better health and higher levels of affluence raises issues for the applicability of social cognitive models to the most disadvantaged older people. [ABSTRACT FROM AUTHOR]

Close monitoring of chemotherapy toxicity can be instrumental in ensuring prompt symptom management and quality care. Our aim was to develop a brief clinical tool to enable daily assessment of chemotherapy toxicity and investigate/establish its content validity, feasibility/applicability, internal consistency and stability. Development of the Daily Chemotherapy Toxicity self‐Assessment Questionnaire (DCTAQ) was based on an initial item pool created from two scoping reviews. Expert panel review (n = 15) and cognitive debriefing with patients with cancer (n = 7) were used to establish content validity. Feasibility/acceptability, applicability (self‐report vs. interview‐like administration), internal consistency (KR‐20) and test–retest reliability (at 1‐hr intervals) of the DCTAQ were field‐tested with 82 patients with breast or colorectal cancer receiving active chemotherapy at eight hospitals. Initial development/content validity stages enabled item revisions and re‐wording that led to a final, 11‐item DCTAQ version with 10 core symptom items plus one open‐ended "any other symptom" item. Feasibility and acceptability were demonstrated through the absence of participant withdrawals, absence of missing data and no complaints about tool length. The DCTAQ was found to have modest internal consistency (KR‐20 = 0.56), but very good test–retest reliability. The DCTAQ is a brief clinical tool that allows for rapid and accurate daily assessments of chemotherapy toxicity in clinical practice. [ABSTRACT FROM AUTHOR]