Evidence map›Paper›PMID 28110382›Full record

ArticlePharmacoEconomics2017

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

Matthew Franklin, Sarah Davis, Michelle Horspool, Wei Sun Kua, Steven Julious

Erratum issuedAbstract read
In one paragraph

Article in PharmacoEconomics, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 10 papers.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

10 citing papers in PubMed.

  1. Trial
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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

5 authors.

Matthew FranklinHealth Economics and Decision Science (HEDS), ScHARR, University of Sheffield, Regent Court, 30 Regent Street, Sheffield, S1 4DA, UK. matt.franklin@sheffield.ac.uk.ORCID http://orcid.org/0000-0002-2774-9439
Sarah DavisHealth Economics and Decision Science (HEDS), ScHARR, University of Sheffield, Regent Court, 30 Regent Street, Sheffield, S1 4DA, UK.
Michelle HorspoolDesign, Trials & Statistics (DTS), ScHARR, University of Sheffield, Regent Court, 30 Regent Street, Sheffield, S1 4DA, UK.
Wei Sun KuaHealth Economics and Decision Science (HEDS), ScHARR, University of Sheffield, Regent Court, 30 Regent Street, Sheffield, S1 4DA, UK.
Steven JuliousDesign, Trials & Statistics (DTS), ScHARR, University of Sheffield, Regent Court, 30 Regent Street, Sheffield, S1 4DA, UK.

Funding

Department of Health 11/01/10
6 · The paper itself

Abstract

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.

Indexed as

Quality-Adjusted Life YearsResearch DesignAdolescentAsthmaChildChild, PreschoolCost SavingsDatabases, FactualFemaleHumansMaleProbabilityRandomized Controlled Trials as TopicRegression AnalysisUnited Kingdom

Identifiers

PMID28110382
PMCPMC5385191

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.