Use of primary care and other healthcare services between age 85 and 90 years: longitudinal analysis of a single-year birth cohort, the Newcastle 85+ study

Objective: To describe, using data from the Newcastle 85+ cohort study, the use of primary care and other healthcare services by 85-year-olds as they age. Design: Longitudinal population-based cohort study. Setting: Newcastle on Tyne and North Tyneside, UK. Participants: Community dwelling and institutionalised men and women recruited through general practices (n=845, 319 men and 526 women). Results: Contact was established with 97% (n=1409/1459) of eligible 85-year-olds, consent obtained from 74% (n=1042/1409) and 851 agreed to undergo the multidimensional health assessment and a general practice medical records review. A total of 845 participants had complete data at baseline for this study (319 male, 526 female), with 344 (118 male, 226 female) reinterviewed at 60 months. After adjusting for confounders, all consultations significantly increased over the 5 years (incidence rate ratio, IRR=1.03, 95% CI 1.01 to 1.05, P=0.001) as did general practitioner (GP) consultations (IRR=1.03, 95% CI 1.01 to 1.05, P=0.006). Significant increases were also observed in inpatient and day hospital use over time, though these disappeared after adjustment for confounders. Conclusions: Our study of primary, secondary and community care use by the very old reveals that, between the ages of 85 and 90 years, older people are much more likely to consult their GP than any other primary healthcare team members. With a rapidly ageing society, it is essential that both current and future GPs are appropriately skilled, and adequately supported by specialist colleagues, as the main healthcare provider for a population with complex and challenging needs

Visually Impaired OLder people's Exercise programme for falls prevenTion (VIOLET): a feasibility study

This study aims to conduct a mixed methods feasibility study to inform the design and conduct of a future definitive RCT of an adapted exercise programme to prevent falls by reducing fear of falling among older people with visual impairment (OPVI). The research questions are: can an existing exercise programme be adapted for OPVI and successfully delivered in the community; is it feasible to conduct an RCT of this intervention and what are the features of a future definitive trial? We propose to: (i) Adapt an existing exercise programme with the full involvement of OPVI and practitioners; (ii) Run a feasibility study in 2 sites to test our proposed measures, trial processes and recruitment; explore acceptability of the intervention; fidelity of and compliance with the intervention. Two stakeholder panels will be established including OPVI aged 60 and over from Newcastle Society for Blind People (NSBP) and Visibility in Glasgow, practitioners and researchers. They will work together to adapt the FaME programme, which is known to be effective in reducing falls in frequent fallers, so that the methods are acceptable for OPVI, whilst retaining the effective components of the exercise. The panels will meet 4 times to adapt the intervention and contribute to decisions on outcome measures and data collection. During this time we will identify OPVI wishing to act as expert stakeholders in the subsequent WPs. OPVI aged 60+ will be recruited from low vision clinics and voluntary organisations and randomised into the intervention or comparator arm. Those in the comparator arm will receive no intervention, but will be offered it after final data collection. The core components of the adapted exercise programme aim to strengthen leg muscles and retrain balance. However, the detail of the methods and timing will be decided by the stakeholder panel. The programme is likely to run once a week over 12 weeks, with each session lasting up to one hour. The final form of delivery will be one of the outcomes of the PPI work in WP1. Participants will be provided with instructions and equipment to do the exercises at home if they wish. The intervention will be delivered by exercise instructors engaged by Health Works, Newcastle and Visibility, Glasgow, in venues agreed with participants. The final primary outcome of the future RCT will be decided by the responsiveness to change, participant burden and participant feedback from this study. The likely candidate primary outcome is fear of falling (Short FES-I scale). The main secondary outcomes will be: activity avoidance; balance/falls risk; number of falls; quality of life; loneliness; depression; adherence to exercise programme; self-reported home exercising. An estimate of cost effectiveness and cost utility of the intervention will be undertaken. In-depth interviews with a sample of OPVI will be conducted to explore their reasons for taking part/not taking part; factors that facilitate/hinder them from participating in exercise groups; their experiences of the recruitment and randomisation process and views on the outcome measures; their experience of the adapted intervention. The interviews will highlight site specific issues to consider for the definitive RCT. Structured interviews will be undertaken with commissioners and practitioners to explore their perspectives on the application of the intervention

Nasal Airway Obstruction Study (NAIROS): a phase III, open-label, mixed-methods, multicentre randomised controlled trial of septoplasty versus medical management of a septal deviation with nasal obstruction

Background Septoplasty (surgery to straighten a deviation in the nasal septum) is a frequently performed operation worldwide, with approximately 250,000 performed annually in the US and 22,000 in the UK. Most septoplasties aim to improve diurnal and nocturnal nasal obstruction. The evidence base for septoplasty clinical effectiveness is hitherto very limited. Aims To establish, and inform guidance for, the best management strategy for individuals with nasal obstruction associated with a deviated septum. Methods/design A multicentre, mixed-methods, open label, randomised controlled trial of septoplasty versus medical management for adults with a deviated septum and a reduced nasal airway. Eligible patients will have septal deflection visible at nasendoscopy and a nasal symptom score ≥ 30 on the NOSE questionnaire. Surgical treatment comprises septoplasty with or without reduction of the inferior nasal turbinate on the anatomically wider side of the nose. Medical management comprises a nasal saline spray followed by a fluorinated steroid spray daily for six months. The recruitment target is 378 patients, recruited from up to 17 sites across Scotland, England and Wales. Randomisation will be on a 1:1 basis, stratified by gender and severity (NOSE score). Participants will be followed up for 12 months post randomisation. The primary outcome measure is the total SNOT-22 score at 6 months. Clinical and economic outcomes will be modelled against baseline severity (NOSE scale) to inform clinical decision-making. The study includes a recruitment enhancement process, and an economic evaluation. Discussion The NAIROS trial will evaluate the clinical effectiveness and cost-effectiveness of septoplasty versus medical management for adults with a deviated septum and symptoms of nasal blockage. Identifying those individuals most likely to benefit from surgery should enable more efficient and effective clinical decision-making, and avoid unnecessary operations where there is low likelihood of patient benefit

Assessing the validity of the global activity limitation indicator in fourteen European countries

Background: The Global Activity Limitation Indicator (GALI), the measure underlying the European indicator Healthy Life Years (HLY), is widely used to compare population health across countries. However, the comparability of the item has been questioned. This study aims to further validate the GALI in the adult European population. Methods: Data from the European Health Interview Survey (EHIS), covering 14 European countries and 152,787 individuals, were used to explore how the GALI was associated with other measures of disability and whether the GALI was consistent or reflected different disability situations in different countries. Results: When considering each country separately or all combined, we found that the GALI was significantly associated with measures of activities of daily living, instrumental activity of daily living, and functional limitations (P < 0.001 in all cases). Associations were largest for activity of daily living and lowest though still high for functional limitations. For each measure, the magnitude of the association was similar across most countries. Overall, however, the GALI differed significantly between countries in terms of how it reflected each of the three disability measures (P < 0.001 in all cases). We suspect cross-country differences in the results may be due to variations in: the implementation of the EHIS, the perception of functioning and limitations, and the understanding of the GALI question. Conclusion: The study both confirms the relevance of this indicator to measure general activity limitations in the European population and the need for caution when comparing the level of the GALI from one country to another

Feasibility of trial procedures for a randomised controlled trial of a community based group exercise intervention for falls prevention for visually impaired older people: the VIOLET study

Background Visually impaired older people (VIOP) have a higher risk of falling than their sighted peers, and are likely to avoid physical activity. The aim was to adapt the existing Falls Management Exercise (FaME) programme for VIOP, delivered in the community, and to investigate the feasibility of conducting a definitive randomised controlled trial (RCT) of this adapted intervention. Methods Two-centre randomised mixed methods pilot trial and economic evaluation of the adapted group-based FaME programme for VIOP versus usual care. A one hour exercise programme ran weekly over 12 weeks at the study sites (Newcastle and Glasgow), delivered by third sector (voluntary and community) organisations. Participants were advised to exercise at home for an additional two hours over the week. Those randomised to the usual activities group received no intervention. Outcome measures were completed at baseline, 12 and 24 weeks. The potential primary outcome was the Short Form Falls Efficacy Scale – International (SFES-I). Participants’ adherence was assessed by reviewing attendance records and self-reported compliance to the home exercises. Adherence with the course content (fidelity) by instructors was assessed by a researcher. Adverse events were collected in a weekly phone call. Results Eighteen participants, drawn from community-living VIOP were screened; 68 met the inclusion criteria; 64 participants were randomised with 33 allocated to the intervention and 31 to the usual activities arm. 94% of participants provided data at the 12 week visit and 92% at 24 weeks. Adherence was high. The intervention was found to be safe with 76% attending nine or more classes. Median time for home exercise was 50 min per week. There was little or no evidence that fear of falling, balance and falls risk, physical activity, emotional, attitudinal or quality of life outcomes differed between trial arms at follow-up. Conclusions The intervention, FaME, was implemented successfully for VIOP and all progression criteria for a main trial were met. The lack of difference between groups on fear of falling was unsurprising given it was a pilot study but there may have been other contributory factors including suboptimal exercise dose and apparent low risk of falls in participants. These issues need addressing for a future trial

Clinical effectiveness of septoplasty versus medical management for nasal airways obstruction: multicentre, open label, randomised controlled trial

OBJECTIVE: To assess the clinical effectiveness of septoplasty. DESIGN: Multicentre, randomised controlled trial. SETTING: 17 otolaryngology clinics in the UK's National Health Service. PARTICIPANTS: 378 adults (≥18 years, 67% men) newly referred with symptoms of nasal obstruction associated with septal deviation and at least moderate symptoms of nasal obstruction (score >30 on the Nasal Obstruction and Symptom Evaluation (NOSE) scale). INTERVENTIONS: Participants were randomised 1:1 to receive either septoplasty (n=188) or defined medical management (n=190, nasal steroid and saline spray for six months), stratified by baseline symptom severity and sex. MAIN OUTCOME MEASURES: The primary outcome measure was patient reported score on the Sino-Nasal Outcome Test-22 (SNOT-22) at six months, with 9 points defined as the minimal clinically important difference. Secondary outcomes included quality of life and objective nasal airflow measures. RESULTS: Mean SNOT-22 scores at six months were 19.9 (95% confidence interval 17.0 to 22.7) in the septoplasty arm (n=152, intention-to-treat population) and 39.5 (36.1 to 42.9) in the medical management arm (n=155); an estimated 20.0 points lower (better) for participants randomised to receive septoplasty (95% confidence interval 16.4 to 23.6, P<0.001, adjusted for baseline continuous SNOT-22 score and the stratification variables sex and baseline NOSE severity categories). Greater improvement in SNOT-22 scores was predicted by higher baseline symptom severity scores. Quality of life outcomes and nasal airflow measures (including peak nasal inspiratory flow and absolute inhalational nasal partitioning ratio) improved more in participants in the septoplasty group. Readmission to hospital with bleeding after septoplasty occurred in seven participants (4% of 174 who had septoplasty), and a further 20 participants (12%) required antibiotics for infections. CONCLUSIONS: Septoplasty is a more effective intervention than a defined medical management regimen with a nasal steroid and saline spray in adults with nasal obstruction associated with a deviated nasal septum. TRIAL REGISTRATION: ISRCTN Registry ISRCTN16168569