Evidence map›Paper›PMID 36914185›Full record

ArticleBMJ open2023

Phase III, two arm, multi-centre, open label, parallel-group randomised designed clinical investigation of the use of a personalised early warning decision support system to predict and prevent acute exacerbations of chronic obstructive pulmonary disease: 'Predict & Prevent AECOPD' - study protocol.

Dalbir Kaur, Rajnikant L Mehta, Hugh Jarrett, Sue Jowett, Nicola K Gale, Alice M Turner, Monica Spiteri, Neil Patel

Registry-linked trialOpen access · goldFull text readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in BMJ open, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04136418 (A Randomised Designed Clinical Investigation of the Use of a Personalised Early Warning Decision Support System With Novel Saliva Bio-profiling to Predict and Prevent Acute Exacerbations of Chronic Obstructive Pulmonary Disease), which is not on this map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
1.3field-weighted citation impact, top 19% of its field
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.

NCT04136418 naunknown statusnot on this map

A Randomised Designed Clinical Investigation of the Use of a Personalised Early Warning Decision Support System With Novel Saliva Bio-profiling to Predict and Prevent Acute Exacerbations of Chronic Obstructive Pulmonary Disease

TypeinterventionalSponsorUniversity of BirminghamRan2020 to 2023Enrolled384ConditionsChronic Obstructive Pulmonary DiseaseArmsCOPDPredict mobile App, Usual care
3 · Its place in the literature

Who cites it

2 citing papers in PubMed, 5 citations in OpenAlex.

  1. Article
  2. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors at 3 institutions in 1 country.

Dalbir KaurWarwick Clinical Trials Unit (BWCTU), Warwick Medical School University of Warwick Coventry, Coventry, UK dalbir.kaur@warwick.ac.uk.ORCID 0000-0003-2722-3848
Rajnikant L MehtaBirmingham Clinical Trials Unit (BCTU), Institute of Applied Health Research, College of Medical and Dental Sciences, University of Birmingham, Birmingham, UK.
Hugh JarrettBirmingham Clinical Trials Unit (BCTU), Institute of Applied Health Research, College of Medical and Dental Sciences, University of Birmingham, Birmingham, UK.
Sue JowettHealth Economics Unit, Institute of Applied Health Research, College of Medical and Dental Sciences, University of Birmingham, Birmingham, UK.
Nicola K GaleHealth Services Management Centre, School of Social Policy Director of Postgraduate Research, College of Social Sciences, University of Birmingham, Birmingham, UK.
Alice M TurnerInstitute of Applied Health Research, College of Medical and Dental Sciences, University of Birmingham, Birmingham, UK.
Monica SpiteriRespiratory Research, Academic Research Unit, Royal Stoke University Hospital, University Hospitals of North Midlands NHS Trust, Staffordshire, UK.
Neil PatelNEPESMO Ltd, Manchester, UK.
University of Birmingham · GBUniversity Hospitals of North Midlands NHS Trust · GBUniversity of Warwick · GB

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionWith 65 million cases globally, chronic obstructive pulmonary disease (COPD) is the fourth leading cause of death and imposes a heavy burden on patients' lives and healthcare resources worldwide. Around half of all patients with COPD have frequent (≥2 per year) acute exacerbations of COPD (AECOPD). Rapid readmissions are also common. Exacerbations impact significantly on COPD outcomes, causing significant lung function decline. Prompt exacerbation management optimises recovery and delays the time to the next acute episode. METHODS/ANALYSIS: The Predict & Prevent AECOPD trial is a phase III, two arm, multi-centre, open label, parallel-group individually randomised clinical trial investigating the use of a personalised early warning decision support system (COPDPredict) to predict and prevent AECOPD. We aim to recruit 384 participants and randomise each individual in a 1:1 ratio to either standard self-management plans with rescue medication (RM) (control arm) or COPDPredict with RM (intervention arm).The trial will inform the future standard of care regarding management of exacerbations in COPD patients. The main outcome measure is to provide further validation, as compared with usual care, for the clinical effectiveness of COPDPredict to help guide and support COPD patients and their respective clinical teams in identifying exacerbations early, with an aim to reduce the total number of AECOPD-induced hospital admissions in the 12 months following each patient's randomisation. ETHICS AND DISSEMINATION: This study protocol is reported in accordance with the guidance set out in the Standard Protocol Items: Recommendations for Interventional Trials statement. Predict & Prevent AECOPD has obtained ethical approval in England (19/LO/1939). On completion of the trial and publication of results a lay findings summary will be disseminated to trial participants. TRIAL REGISTRATION NUMBER: NCT04136418.

Indexed as

Pulmonary Disease, Chronic ObstructiveResearch DesignClinical Trials, Phase III as TopicHumansMulticenter Studies as TopicOutcome Assessment, Health CareRandomized Controlled Trials as TopicTreatment OutcomeChronic airways diseaseRESPIRATORY MEDICINE (see Thoracic Medicine)Thoracic medicine

Identifiers

PMID36914185
PMCPMC10016266
OpenAlexW4324101832

What OpenQuestion holds

Textfull text, public
LicenceCC BY
measurements read13
Read underepoch 390

Registered trials

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.