Dataset Information

Protocol for Project Fizzyo, an analytic longitudinal observational cohort study of physiotherapy for children and young people with cystic fibrosis, with interrupted time-series design.

ABSTRACT: INTRODUCTION:Daily physiotherapy is believed to mitigate the progression of cystic fibrosis (CF) lung disease. However, physiotherapy airway clearance techniques (ACTs) are burdensome and the evidence guiding practice remains weak. This paper describes the protocol for Project Fizzyo, which uses innovative technology and analysis methods to remotely capture longitudinal daily data from physiotherapy treatments to measure adherence and prospectively evaluate associations with clinical outcomes. METHODS AND ANALYSIS:A cohort of 145 children and young people with CF aged 6-16 years were recruited. Each participant will record their usual physiotherapy sessions daily for 16 months, using remote monitoring sensors: (1) a bespoke ACT sensor, inserted into their usual ACT device and (2) a Fitbit Alta HR activity tracker. Real-time breath pressure during ACTs, and heart rate and daily step counts (Fitbit) are synced using specific software applications. An interrupted time-series design will facilitate evaluation of ACT interventions (feedback and ACT-driven gaming). Baseline, mid and endpoint assessments of spirometry, exercise capacity and quality of life and longitudinal clinical record data will also be collected.This large dataset will be analysed in R using big data analytics approaches. Distinct ACT and physical activity adherence profiles will be identified, using cluster analysis to define groups of individuals based on measured characteristics and any relationships to clinical profiles assessed. Changes in adherence to physiotherapy over time or in relation to ACT interventions will be quantified and evaluated in relation to clinical outcomes. ETHICS AND DISSEMINATION:Ethical approval for this study (IRAS: 228625) was granted by the London-Brighton and Sussex NREC (18/LO/1038). Findings will be disseminated via peer-reviewed publications, at conferences and via CF clinical networks. The statistical code will be published in the Fizzyo GitHub repository and the dataset stored in the Great Ormond Street Hospital Digital Research Environment. TRIAL REGISTRATION NUMBER:ISRCTN51624752; Pre-results.

SUBMITTER: Raywood E

PROVIDER: S-EPMC7542954 | biostudies-literature | 2020 Oct

REPOSITORIES: biostudies-literature

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Protocol for Project Fizzyo, an analytic longitudinal observational cohort study of physiotherapy for children and young people with cystic fibrosis, with interrupted time-series design.

Raywood Emma E Douglas Helen H Kapoor Kunal K Filipow Nicole N Murray Nicky N O'Connor Rachel R Stott Lee L Saul Greg G Kuzhagaliyev Tim T Davies Gwyneth G Liakhovich Olga O Van Schaik Tempest T Furtuna Bianca B Booth John J Shannon Harriet H Bryon Mandy M Main Eleanor E

BMJ open 20201007 10

<h4>Introduction</h4>Daily physiotherapy is believed to mitigate the progression of cystic fibrosis (CF) lung disease. However, physiotherapy airway clearance techniques (ACTs) are burdensome and the evidence guiding practice remains weak. This paper describes the protocol for Project Fizzyo, which uses innovative technology and analysis methods to remotely capture longitudinal daily data from physiotherapy treatments to measure adherence and prospectively evaluate associations with clinical out ...[more]

PMID: 33033031

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Project description:A national tax increase, which became known as the "alcopops tax", was introduced in Australia on the 27th April 2008 on ready-to-drink alcoholic beverages, which are consumed predominantly by young people. The affordability of alcohol has been identified as the strongest environmental driver of alcohol consumption, and alcohol consumption is a well-known risk factor in the spread of sexually transmitted infections via its association with sexual risk-taking. We conducted a study to investigate whether there was any association between the introduction of the tax and changes in national chlamydia rates: (i) notification rates (diagnoses per 100,000 population; primary outcome and standard approach in alcohol taxation studies), and (ii) test positivity rates (diagnoses per 100 tests; secondary outcome) among 15-24 and 25-34-year-olds, using interrupted time series analysis. Gender- and age-specific chlamydia trends among those 35 and older were applied as internal control series and gender- and age-specific consumer price index-adjusted per capita income trends were controlled for as independent variables. We hypothesised that the expected negative association between the tax and chlamydia notification rates might be masked due to increasing chlamydia test counts over the observation period (2000 to 2016). We hypothesised that the association between the tax and chlamydia test positivity rates would occur as an immediate level decrease, as a result of a decrease in alcohol consumption, which, in turn, would lead to a decrease in risky sexual behaviour and, hence, chlamydia transmission. None of the gender and age-specific population-based rates indicated a significant immediate or lagged association with the tax. However, we found an immediate decrease in test positivity rates for 25-34-year-old males (27% reduction-equivalent to 11,891 cases prevented post-tax) that remained detectable up to a lag of six months and a decrease at a lag of six months for 15-24-year-old males (31% reduction-equivalent to 16,615 cases prevented) following the tax. For no other gender or age combination did the change in test positivity rates reach significance. This study adds to the evidence base supporting the use of alcohol taxation to reduce health-related harms experienced by young people and offers a novel method for calculating sexually transmitted infection rates for policy evaluation.

Project description:To conduct a systematic review to evaluate the effects of physiotherapy exercises delivered via telemedicine on lung function and quality-of-life in people with Cystic Fibrosis (CF). The databases AMED, CINAHL and MEDLINE were searched from December 2001 until December 2021. Reference lists of included studies were hand-searched. The PRISMA 2020 statement was used to report the review. Studies of any design reported in the English language, included participants with CF, and within outpatient settings were included. Meta-analysis was not deemed appropriate due to the diversity of interventions and heterogeneity of the included studies. Following screening, eight studies with 180 total participants met the inclusion criteria. Sample sizes ranged from 9 to 41 participants. Research designs included five single cohort intervention studies, two randomised control trials and one feasibility study. Telemedicine-based interventions included Tai-Chi, aerobic, and resistance exercise delivered over a study period of six to twelve weeks. All included studies which measured percentage predicted forced expiratory volume in one second found no significant difference. Five studies measuring the Cystic Fibrosis Questionnaire–Revised (CFQ-R) respiratory domain found improvements, however, did not meet statistical significance. For the CFQ-R physical domain, measured by five studies, two studies found an improvement, although not statistically significant. No adverse events were reported across all studies. The included studies indicate that telemedicine-based exercise over 6–12 weeks does not significantly change lung function or quality-of-life in people with CF. Whilst the role of telemedicine in the care of pwCF is acceptable and promising; further research with standardised outcome measures, larger sample sizes and longer follow-up are required before clinical practice recommendations can be developed. Author summary Preliminary evidence suggests that exercise for people with cystic fibrosis may be beneficial for lung function and quality of life improvements, but we do not know if telemedicine-based exercise can achieve similar outcomes. The current review highlighted increases within quality of life self-reported outcomes for the respiratory and physical domains, however no significant lung function improvements were found. The quality of the available evidence is low-moderate, due to poor methodological rigour and statistical power which reduces the strength of the review findings. Therefore, future large scale, high-quality randomised controlled trials with longer follow-up duration and standardised interventions would provide robust statistical evidence to optimise clinical practice and develop gold standard telemedicine-based exercise guidelines.

Dataset Information

Protocol for Project Fizzyo, an analytic longitudinal observational cohort study of physiotherapy for children and young people with cystic fibrosis, with interrupted time-series design.

Publications

Protocol for Project Fizzyo, an analytic longitudinal observational cohort study of physiotherapy for children and young people with cystic fibrosis, with interrupted time-series design.

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