Preventing and lessening exacerbations of asthma in school-age children associated with a new term (PLEASANT): study protocol for a cluster randomised control trial

Horspool, Michelle; Julious, Steven A.; Boote, Jonathan; Bradburn, Michael; Cooper, Cindy; Davis, Sarah; Elphick, Heather; Norman, Paul; Smithson, W. Henry; vanStaa, Tjeerd

doi:10.1186/1745-6215-14-297

Cited by 15 publications

(16 citation statements)

References 19 publications

(19 reference statements)

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“…In 2008, in the Global Health Statistical Report of the World Health Organization (WHO), cardiovascular and cerebrovascular diseases were reported to be the second leading cause of human mortality, following malignant tumors (2). In May 2014, the WHO updated the evaluation report regarding global health, indicating that ischemic heart disease, apoplexy, chronic obstructive pulmonary disease and lower respiratory infection are the four major causes of human mortality (3). Globally, ~7 million people succumb to ischemic heart disease and ~50% of patients succumb to myocardial ischemia/reperfusion (I/R) injury.…”

Section: Introductionmentioning

confidence: 99%

Cardioprotective effects of anisodamine against myocardial ischemia/reperfusion injury through the inhibition of oxidative stress, inflammation and apoptosis

Yao

Lin

et al. 2017

Mol Med Report

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The aim of the present study was to investigate the cardioprotective effects of anisodamine against myocardial ischemia/reperfusion (I/R) injury and the molecular mechanisms involved. The present results demonstrated that anisodamine attenuated myocardial infarct sizes, decreased the levels of creatine kinase and lactate dehydrogenase, whereas it increased the left ventricular (LV) systolic pressure, the LV end‑diastolic pressure, and the LV pressure maximum rising and falling rates in a myocardial I/R rat model. In addition, anisodamine was revealed to suppress oxidative stress, inflammatory factor production and myocardial cell apoptosis, as demonstrated by the downregulation of caspase‑3 and apoptosis regulator BAX protein expression. The production of reactive oxygen species was decreased and the protein expression of inducible nitric oxide synthase (iNOS) was downregulated, whereas the expression of endothelial NOS was enhanced. In addition, the activity of nicotinamide‑adenine dinucleotide phosphate oxidase (Nox) was suppressed and the expression of Nox4 was downregulated in rats with myocardial I/R injury. In conclusion, the results of the present study suggested that anisodamine exerted a cardioprotective effect against myocardial I/R injury in rats, through the inhibition of oxidative stress, the suppression of inflammatory processes and the inhibition of myocardial cell apoptosis.

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Section: Introductionmentioning

confidence: 99%

Cardioprotective effects of anisodamine against myocardial ischemia/reperfusion injury through the inhibition of oxidative stress, inflammation and apoptosis

Yao

Lin

et al. 2017

Mol Med Report

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“…were not excluded by their GP; note, GPs would be able to exclude patients from the intervention, as appropriate, if the intervention were to be rolled out nationally) in the designated time window for the intervention to have an effect. ITT groups were assessed as part of the main clinical analysis [9]. …”

Section: Methodsmentioning

confidence: 99%

“…The PLEASANT (Preventing and Lessening Exacerbations of Asthma in School-age children Associated with a New Term) trial was a cluster RCT with a primary care-based intervention evaluated using CPRD [9]. This paper uses the PLEASANT RCT as a case study to describe the strengths and limitations of performing an economic evaluation (cost-per-QALY analysis in this case) using only data from a large observational database.…”

Section: Introductionmentioning

confidence: 99%

Economic Evaluations Alongside Efficient Study Designs Using Large Observational Datasets: the PLEASANT Trial Case Study

et al. 2017

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BackgroundLarge observational datasets such as Clinical Practice Research Datalink (CPRD) provide opportunities to conduct clinical studies and economic evaluations with efficient designs.ObjectivesOur objectives were to report the economic evaluation methodology for a cluster randomised controlled trial (RCT) of a UK NHS-delivered public health intervention for children with asthma that was evaluated using CPRD and describe the impact of this methodology on results.MethodsCPRD identified eligible patients using predefined asthma diagnostic codes and captured 1-year pre- and post-intervention healthcare contacts (August 2012 to July 2014). Quality-adjusted life-years (QALYs) 4 months post-intervention were estimated by assigning utility values to exacerbation-related contacts; a systematic review identified these utility values because preference-based outcome measures were not collected. Bootstrapped costs were evaluated 12 months post-intervention, both with 1-year regression-based baseline adjustment (BA) and without BA (observed).ResultsOf 12,179 patients recruited, 8190 (intervention 3641; control 4549) were evaluated in the primary analysis, which included patients who received the protocol-defined intervention and for whom CPRD data were available. The intervention’s per-patient incremental QALY loss was 0.00017 (bias-corrected and accelerated 95% confidence intervals [BCa 95% CI] –0.00051 to 0.00018) and cost savings were £14.74 (observed; BCa 95% CI –75.86 to 45.19) or £36.07 (BA; BCa 95% CI –77.11 to 9.67), respectively. The probability of cost savings was much higher when accounting for BA versus observed costs due to baseline cost differences between trial arms (96.3 vs. 67.3%, respectively).ConclusionEconomic evaluations using data from a large observational database without any primary data collection is feasible, informative and potentially efficient.Clinical Trials Registration Number: ISRCTN03000938.Electronic supplementary materialThe online version of this article (doi:10.1007/s40273-016-0484-y) contains supplementary material, which is available to authorized users.

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“…The study was a cluster randomised trial 17 to assess if a letter sent by a GP to the parents/carers of school-aged children with asthma, reminding them to take their medication, reduces the number of unscheduled medical contacts after return to school following summer holiday in September. The unit of cluster was general practices; site recruitment commenced in January 2013, with the intervention being delivered during the week commencing 29 July 2013.…”

Section: Trial Designmentioning

confidence: 99%

PLEASANT: Preventing and Lessening Exacerbations of Asthma in School-age children Associated with a New Term – a cluster randomised controlled trial and economic evaluation

Julious

Horspool

Davis

et al. 2016

Health Technol Assess

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BackgroundAsthma episodes and deaths are known to be seasonal. A number of reports have shown peaks in asthma episodes in school-aged children associated with the return to school following the summer vacation. A fall in prescription collection in the month of August has been observed, and was associated with an increase in the number of unscheduled contacts after the return to school in September.ObjectiveThe primary objective of the study was to assess whether or not a NHS-delivered public health intervention reduces the September peak in unscheduled medical contacts.DesignCluster randomised trial, with the unit of randomisation being 142 NHS general practices, and trial-based economic evaluation.SettingPrimary care.InterventionA letter sent (n = 70 practices) in July from their general practitioner (GP) to parents/carers of school-aged children with asthma to remind them of the importance of taking their medication, and to ensure that they have sufficient medication prior to the start of the new school year in September. The control group received usual care.Main outcome measuresThe primary outcome measure was the proportion of children aged 5–16 years who had an unscheduled medical contact in September 2013. Supporting end points included the proportion of children who collected prescriptions in August 2013 and unscheduled contacts through the following 12 months. Economic end points were quality-adjusted life-years (QALYs) gained and costs from an NHS and Personal Social Services perspective.ResultsThere is no evidence of effect in terms of unscheduled contacts in September. Among children aged 5–16 years, the odds ratio (OR) was 1.09 [95% confidence interval (CI) 0.96 to 1.25] against the intervention. The intervention did increase the proportion of children collecting a prescription in August (OR 1.43, 95% CI 1.24 to 1.64) as well as scheduled contacts in the same month (OR 1.13, 95% CI 0.84 to 1.52). For the wider time intervals (September–December 2013 and September–August 2014), there is weak evidence of the intervention reducing unscheduled contacts. The intervention did not reduce unscheduled care in September, although it succeeded in increasing the proportion of children collecting prescriptions in August as well as having scheduled contacts in the same month. These unscheduled contacts in September could be a result of the intervention, as GPs may have wanted to see patients before issuing a prescription. The economic analysis estimated a high probability that the intervention was cost-saving, for baseline-adjusted costs, across both base-case and sensitivity analyses. There was no increase in QALYs.LimitationThe use of routine data led to uncertainty in the coding of medical contacts. The uncertainty was mitigated by advice from a GP adjudication panel.ConclusionsThe intervention did not reduce unscheduled care in September, although it succeeded in increasing the proportion of children both collecting prescriptions and having scheduled contacts in August. After September there is weak evidence in favour of the intervention. The intervention had a favourable impact on costs but did not demonstrate any impact on QALYs. The results of the trial indicate that further work is required on assessing and understanding adherence, both in terms of using routine data to make quantitative assessments, and through additional qualitative interviews with key stakeholders such as practice nurses, GPs and a wider group of children with asthma.Trial registrationCurrent Controlled Trials ISRCTN03000938.Funding detailsThis project was funded by the NIHR Health Technology Assessment programme and will be published in full inHealth Technology Assessment; Vol. 20, No. 93. See the HTA programme website for further project information.

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Preventing and lessening exacerbations of asthma in school-age children associated with a new term (PLEASANT): study protocol for a cluster randomised control trial

Cited by 15 publications

References 19 publications

Cardioprotective effects of anisodamine against myocardial ischemia/reperfusion injury through the inhibition of oxidative stress, inflammation and apoptosis

Cardioprotective effects of anisodamine against myocardial ischemia/reperfusion injury through the inhibition of oxidative stress, inflammation and apoptosis

Economic Evaluations Alongside Efficient Study Designs Using Large Observational Datasets: the PLEASANT Trial Case Study

PLEASANT: Preventing and Lessening Exacerbations of Asthma in School-age children Associated with a New Term – a cluster randomised controlled trial and economic evaluation

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