Evaluation of outcome reporting in clinical trials of physiotherapy in bronchiectasis: The first stage of core outcome set development.

INTRODUCTION: The aim of this study is to explore outcomes currently reported in physiotherapy trials for bronchiectasis and investigate the level of consistency in outcome reporting. This mapping of outcomes will be used to inform the development of a core outcome set (COS) for physiotherapy research in bronchiectasis. Outcomes reported in randomised clinical trials (RCTs) and RCT protocols were reviewed and evaluated. We included trials with physiotherapy as the main intervention, including pulmonary rehabilitation, exercise prescription, airway clearance, positive expiratory pressure devices, breathing training, self-management plans, and home exercise program. Medline, CINAHL, Scopus, Cochrane Central Register of Controlled Trials (CENTRAL), and the physiotherapy evidence database (PEDro) were searched from inception using a prespecified search strategy. Records including adult patients with bronchiectasis were included. Outcomes were listed verbatim and categorised into domains based on a pre-specified system, frequency of reporting and sources of variation were inspected. RESULTS: Of 2158 abstracts screened, 37 trials (1202 participants) and 17 trial protocols were identified. Eighteen different physiotherapy techniques were investigated. A total of 331 outcomes were reported. No single outcome was reported by all trials. The most reported outcomes were lung function (27 trials, 50%), health related quality of life (26 trials, 48.1%), and dyspnoea (18 trials, 33.3%). A list of 104 unique outcomes covering 23 domains was created. Trials focus on physiological outcomes, mainly those related to respiratory system functions. Outcomes related to functioning and life impact are often neglected. CONCLUSION: Outcome reporting in physiotherapy research for bronchiectasis was found to be inconsistent in terms of choosing and defining outcomes. Developing a core outcome set in this area of research is needed to facilitate aggregation of future trial results in systematic reviews that will in turn inform the strength of evidence for the effectiveness of physiotherapy. Outcome choice should include all stakeholders, including patients. TRIAL REGISTRATION: This study is registered in the PROSPERO registry under the number CRD42021266247.

Does availability of point of care C-reactive protein measurement affect provision of antibiotics in a community respiratory service?

Antibiotic resistance presents a growing threat to health systems and patients at a global scale. Point of care (POC) C-reactive protein (CRP) measurement, as an adjunct to exacerbation assessment, has been studied in primary and secondary care and may represent a useful tool for community teams. A retrospective service review was conducted to determine the effect of CRP measurement on antibiotic provision in a community respiratory setting, with chronic obstructive pulmonary disease (COPD) and bronchiectasis exacerbations. This review compared antibiotic provision for COPD and bronchiectasis patients for those where CRP was measured versus those where it was not. It was found that antibiotic provision dropped by almost 25% points for COPD exacerbations, and almost 59% in bronchiectasis, when a CRP measurement was taken as a component of a respiratory assessment. Antibiotics were also provided at a greater amount based on symptom presentation. Therefore, it is concluded that CRP measurement correlates with a reduction in antibiotic provision, highlighting its use alongside symptom assessment in future work.

Impact of community-based chronic obstructive pulmonary disease service, a multidisciplinary intervention in an area of high deprivation: a longitudinal matched controlled study.

OBJECTIVE: To examine the effects of a consultant-led, community-based chronic obstructive pulmonary disease (COPD) service, based in a highly deprived area on emergency hospital admissions. DESIGN: A longitudinal matched controlled study using difference-in-differences analysis to compare the change in outcomes in the intervention population to a matched comparison population, 5 years before and after implementation. SETTING: A deprived district in the North West of England between 2005 and 2016. INTERVENTION: A community-based, consultant-led COPD service providing diagnostics, treatment and rehabilitation from 2011 to 2016. MAIN OUTCOME MEASURES: Emergency hospital admissions, length of stay per emergency admission and emergency readmissions for COPD. RESULTS: The intervention was associated with 24 fewer emergency COPD admissions per 100 000 population per year (95% CI -10.6 to 58.8, p=0.17) in the postintervention period, relative to the control group. There were significantly fewer emergency admissions in populations with medium levels of deprivation (64 per 100 000 per year; 95% CI 1.8 to 126.9) and among men (60 per 100 000 per year; 95% CI 12.3 to 107.3). CONCLUSION: We found limited evidence that the service reduced emergency hospital admissions, after an initial decline the effect was not sustained. The service, however, may have been more effective in some subgroups.

Asymptomatic sleep abnormalities are a common early feature in patients with Huntington's disease.

Huntington's disease (HD) is a fatal neurodegenerative disease characterized by motor, cognitive, and psychiatric disturbance. In this article, we used polysomnography, actigraphy and a variety of validated questionnaires to ascertain the extent to which sleep changes are identifiable and measurable in mild stage HD, and importantly, to see whether patients are negatively impacted by the changes in their sleep. We found significant differences in sleep architecture and sleep efficiency in patients compared with controls using polysomnography. However, patient scores on the Functional Outcomes of Sleep Questionnaire, Medical Outcomes of Sleep Scale, and Epworth Sleepiness Scale were not significantly different to controls. These results suggest that although marked changes in sleep architecture are present in early HD and can be detected using polysomnography, patients do not necessarily recognize or report these abnormalities.

Effect of treatment with continuous positive airway pressure or oxygen on sleep-disordered breathing in patients with heart failure: results of the Sleep Events, Arrhythmias, and Respiratory Analysis in Chronic Heart Failure (SEARCH) study.

The response to sleep-disordered breathing (SDB)-directed therapy was evaluated using the Clear Path home-based monitoring system. There were 26 patients with heart failure enrolled in the Sleep Events, Arrhythmias, and Respiratory Analysis in Chronic Heart Failure (SEARCH) study with SDB requiring treatment (apnea-hypopnea index [AHI] >or=15 events/h). Patients were monitored using both standard polysomnography and the Clear Path system to determine the change in SDB parameters before and after initiation of therapy. Accuracy of the Clear Path system compared with polysomnography was >or=87% to detect SDB events. A marked reduction in the mean number of sleep time respiratory disturbances was observed by both techniques after the initiation of SDB-directed therapy, and 21 patients (87.5%) experienced a 16.7-events/h mean reduction in AHI. Thus, the Clear Path system appears to be a useful device to monitor response to SDB-directed treatment for apnea in patients with heart failure.

Idiopathic hypersomnia: a study of 77 cases.

STUDY OBJECTIVES: To review the clinical and polysomnographic characteristics of idiopathic hypersomnia as well as the long-term response to treatment. SETTING: The Respiratory Support and Sleep Centre at Papworth Hospital, Cambridge, UK. PATIENTS AND DESIGN: A large database of more than 6000 patients with sleep disorders was reviewed. A retrospective study of the clinical and polysomnographic characteristics of 77 patients with idiopathic hypersomnia was performed. Comparison with a similar group of patients with narcolepsy was performed. The response to drug treatment was assessed in 61 patients over a mean follow-up of 3.8 years. MEASUREMENTS AND RESULTS: Idiopathic hypersomnia was 60% as prevalent as narcolepsy. Comparison with a similar group of patients with narcolepsy showed that those with idiopathic hypersomnia were more likely to have prolonged unrefreshing daytime naps, a positive family history, increased slow-wave sleep, and a longer sleep latency on the Multiple Sleep Latency Test. The results of the Multiple Sleep Latency Test were not helpful in predicting disease severity or treatment response. The clinical features were heterogeneous and of variable severity. The majority of patients with idiopathic hypersomnia had symptoms that remained stable over many years, but 11% had spontaneous remission, which was never seen in narcolepsy. Two thirds of patients with idiopathic hypersomnolence had a sustained improvement in daytime somnolence with medication, although a third needed high doses or combinations of drugs. CONCLUSIONS: Idiopathic hypersomnolence has characteristic clinical and polysomnographic features but the prolonged latency on the Multiple Sleep Latency Test raises doubt about the validity of this test within the current diagnostic criteria. The disease often responds well to treatment and a substantial minority of patients appear to spontaneously improve.

Validation and clinical utility of a simple in-home testing tool for sleep-disordered breathing and arrhythmias in heart failure: results of the Sleep Events, Arrhythmias, and Respiratory Analysis in Congestive Heart Failure (SEARCH) study.

Fifty patients with New York Heart Association class III systolic heart failure were enrolled in this prospective multicenter study that compared the diagnostic accuracy of a home-based cardiorespiratory testing system with standard attended polysomnography. Patients underwent at least 2 nights of evaluation and were scored by blinded observers. At diagnostic cutoff points of > or =5, > or =10, and > or =15 events per hour for respiratory disturbance severity, polysomnography demonstrated a sleep-disordered breathing prevalence of 69%, 59%, and 49%, respectively. Compared with polysomnography, the cardiorespiratory testing system demonstrated predictive accuracies of 73%, 73%, and 75%, which improved to 87%, 87%, and 83%, respectively, when analysis of covariance suggested reanalysis omitting one site's data. The system accurately identified both suspected and unsuspected arrhythmias. The device was judged by 80% of patients to be easy or very easy to use, and 74% of patients expressed a preference for the in-home system. Therefore, this system represents a reasonable home testing device in these patients.

Prolonged invasive ventilation following acute ventilatory failure in COPD: weaning results, survival, and the role of noninvasive ventilation.

BACKGROUND: Invasive ventilation for COPD has significant mortality, and weaning can be difficult. At Papworth Hospital, we provide a specialist weaning service using noninvasive ventilation (NIV) for patients requiring prolonged invasive ventilation after recovery from acute illness. We analyzed our results for patients with COPD to identify factors associated with weaning outcome and survival. METHODS: A retrospective analysis was conducted of COPD patients admitted for weaning from invasive ventilation, from 1992 to 2003. Weaning success and survival were assessed. Associations were sought between these outcomes and age, sex, spirometry, arterial blood gas levels, APACHE (acute physiology and chronic health evaluation) II score, length of stay (LOS), and the use of NIV and long-term oxygen therapy. RESULTS: Sixty-seven patients were identified, all of whom were receiving tracheostomy ventilation on transfer to the Respiratory Support and Sleep Centre (RSSC). Sixty-four patients (95.5%) were weaned, and 62 patients survived to hospital discharge. NIV was used in weaning 40 patients and in the long term in 25 patients. Median survival was 2.5 years (interquartile range, 0.7 to 4.6 years). One-year, 2-year, and 5-year survival rates were 68%, 54%, and 25%, respectively. Long-term survival was inversely associated with age and LOS in the ICU and the RSSC. The provision of maintenance NIV after weaning was associated with better long-term survival, independent of age and LOS (hazard rate, 0.48; p = 0.03). CONCLUSIONS: These results demonstrate that a specialist multidisciplinary approach, including the use of NIV, can be successful in weaning most COPD patients from prolonged invasive ventilation. The data also suggest that long-term NIV may improve survival in selected patients.

Periodic limb movement in a community population detected by a new actigraphy technique.

BACKGROUND: Periodic limb movements (PLMs) have been studied in both community and sleep clinic populations using polysomnography. An alternative detection method is actigraphy. Our aims were to determine the frequency of PLMs, measured by actigraphy in a community sample, and to assess the relationships of PLMs with age, gender, and reported sleep-related symptoms. METHODS: Volunteers had bilateral foot actigraphy (Cambridge Neurotechnology) at home and completed sleep questionnaires. Actigraphy was scored for PLMs per hour in bed (PLMI) and statistical analysis performed to assess possible associations. RESULTS: PLMI (mean of two nights) ranged from 0 to 60.3 and 37% of the sample had a PLMI> or =5. Men had significantly higher PLMIs than females (P=0.003) but PLMI was not correlated with age. There was a modest but significant correlation between subjectively reported restless leg severity and PLMI (r=0.238; P=0.003), but none with reported sleepiness. CONCLUSIONS: This actigraphy technique is a practical and reliable tool for community studies. A large proportion of this community sample, particularly men, had PLMs. PLMI was not correlated with age or Epworth Sleepiness Score.