Evidence map›Paper›PMID 34084785›Full record

ReviewERJ open research2021

Safety data in randomised real-world evidence studies: Salford Lung Study learnings.

Catherine Harvey, Ashley Woodcock, Jørgen Vestbo, Courtney Crim, Lucy Frith, Nawar Diar Bakerly, John P New, Claire Williams, Hanaa Elkhenini, Nasir Majeed and 4 more

Open access · goldAbstract readReview
In one paragraph

Review in ERJ open research, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
0.3field-weighted citation impact, top 27% 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.

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

1 citing paper in PubMed, 1 citations in OpenAlex.

  1. 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

14 authors at 5 institutions in 2 countries.

Catherine HarveyGlaxoSmithKline plc, Uxbridge, Middlesex, UK.
Ashley WoodcockManchester Academic Health Sciences Centre, The University of Manchester, Manchester, UK.
Jørgen VestboManchester Academic Health Sciences Centre, The University of Manchester, Manchester, UK.ORCID https://orcid.org/0000-0001-6355-6362
Courtney CrimGlaxoSmithKline plc, Research Triangle Park, NC, USA.
Lucy FrithGlaxoSmithKline plc, Uxbridge, Middlesex, UK.
Nawar Diar BakerlyManchester Academic Health Sciences Centre, The University of Manchester, Manchester, UK.
John P NewManchester Academic Health Sciences Centre, The University of Manchester, Manchester, UK.
Claire WilliamsNorthWest EHealth, Manchester, UK.
Hanaa ElkheniniPennine Acute Hospitals NHS Trust, Oldham, UK.
Nasir MajeedSalford Royal NHS Foundation Trust, Salford, UK.
Glenn CardwellGlaxoSmithKline plc, Uxbridge, Middlesex, UK.
Susan CollierGlaxoSmithKline plc, Uxbridge, Middlesex, UK.
Loretta JacquesGlaxoSmithKline plc, Uxbridge, Middlesex, UK.
Joanne FletcherGlaxoSmithKline plc, Uxbridge, Middlesex, UK.
GlaxoSmithKline (United Kingdom) · GBManchester Academic Health Science Centre · GBPennine Acute Hospitals NHS Trust · GBResearch Triangle Park Foundation · USSalford Royal NHS Foundation Trust · GB

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Evidence to support clinical decision making must be based on safety data that have been captured, analysed and interpreted in a robust and reliable way. Randomised real-world evidence (RRWE) studies provide the opportunity to evaluate the use of medicines in patients and settings representative of routine clinical practice. However, elements that underpin the design of RRWE studies can have a significant impact upon the analysis, interpretation and implications of safety data. In this narrative review, we use data from the Salford Lung Study; two prospective, 12-month, open-label, parallel-group, phase III randomised controlled trials conducted in primary care in the UK; to highlight the importance of capturing treatment modifications when attempting to evaluate safety events according to actual treatment exposure. We demonstrate that analysing safety data by actual treatment received (

Identifiers

PMID34084785
PMCPMC8165374
OpenAlexW3138514479

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

None linked

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.