Evidence map›Paper›PMID 32316077›Full record

Observational studyPharmacoepidemiology and drug safety2020

Use of record linkage to evaluate treatment outcomes and trial eligibility in a real-world metastatic prostate cancer population in Scotland.

Kelly Baillie, Tanja Mueller, Jiafeng Pan, Jennifer Laskey, Marion Bennie, Christine Crearie, Kimberley Kavanagh, Samantha Alvarez-Madrazo, David Morrison, Julie Clarke and 5 more

Abstract readComparative StudyObservational Study
In one paragraph

Observational study in Pharmacoepidemiology and drug safety, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed, 2 pooled it
–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

8 citing papers in PubMed, 2 syntheses or guidelines pooled it.

  1. Pooled it
  2. Pooled it
  3. Article
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  8. Observational
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

15 authors.

Kelly BaillieBeatson West of Scotland Cancer Centre, NHS Greater Glasgow & Clyde, Glasgow, UK.ORCID 0000-0001-5029-0841
Tanja MuellerStrathclyde Institute of Pharmacy and Biomedical Sciences, University of Strathclyde, Glasgow, UK.ORCID 0000-0002-0418-4789
Jiafeng PanDepartment of Mathematics and Statistics, University of Strathclyde, Glasgow, UK.
Jennifer LaskeyBeatson West of Scotland Cancer Centre, NHS Greater Glasgow & Clyde, Glasgow, UK.
Marion BennieStrathclyde Institute of Pharmacy and Biomedical Sciences, University of Strathclyde, Glasgow, UK.
Christine CrearieBeatson West of Scotland Cancer Centre, NHS Greater Glasgow & Clyde, Glasgow, UK.
Kimberley KavanaghDepartment of Mathematics and Statistics, University of Strathclyde, Glasgow, UK.
Samantha Alvarez-MadrazoStrathclyde Institute of Pharmacy and Biomedical Sciences, University of Strathclyde, Glasgow, UK.
David MorrisonInstitute of Health and Wellbeing, University of Glasgow, Glasgow, UK.
Julie ClarkeBeatson West of Scotland Cancer Centre, NHS Greater Glasgow & Clyde, Glasgow, UK.
Aileen KeelInnovative Healthcare Delivery Programme (IHDP), University of Edinburgh, Edinburgh, UK.
David CameronCancer Research UK Edinburgh Centre, University of Edinburgh, Edinburgh, UK.
Olivia WuInstitute of Health and Wellbeing, University of Glasgow, Glasgow, UK.
Amanj KurdiStrathclyde Institute of Pharmacy and Biomedical Sciences, University of Strathclyde, Glasgow, UK.
Robert J JonesBeatson West of Scotland Cancer Centre, NHS Greater Glasgow & Clyde, Glasgow, UK.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeNew treatments are introduced into standard care based on clinical trial results. However, it is not clear if these benefits are reflected in the broader population. This study analysed the clinical outcomes of patients with metastatic castration-resistant prostate cancer, treated with abiraterone and enzalutamide, within the Scottish National Health Service.

methodsRetrospective cohort study using record linkage of routinely collected healthcare data (study period: February 2012 to February 2017). Overall survival (OS) was analysed using Kaplan-Meier methods and Cox Proportional Hazard models; a subgroup analysis comprised potentially trial-eligible patients.

resultsOverall, 271 patients were included and 73.8% died during the study period. Median OS was poorer than in the pivotal trials, regardless of medication and indication: 10.8 months (95% confidence interval [CI] 8.6-15.1) and 20.9 months (95% CI 14.9-29.0) for abiraterone, and 12.6 months (95% CI 10.5-18.2) and 16.0 months (95% CI 9.8-not reached) for enzalutamide, post and pre chemotherapy, respectively. Only 46% of patients were potentially "trial eligible" and in this subgroup OS improved. Factors influencing survival included baseline performance status, and baseline prostate-specific antigen, alkaline phosphatase, and albumin levels.

conclusionsPoorer prognostic features of non-trial eligible patients impact real-world outcomes of cancer medicines. Electronic record linkage of routinely collected healthcare data offers an opportunity to report outcomes on cancer medicines at scale and describe population demographics. The availability of such observational data to supplement clinical trial results enables patients and clinicians to make more informed treatment decisions, and policymakers to contextualise trial findings.

Indexed as

Clinical Trials as TopicElectronic Health RecordsEligibility DeterminationMedical Record LinkagePatient SelectionAdultAgedAged, 80 and overAndrogen AntagonistsAndrostenesBenzamidesClinical Decision-MakingHumansMaleMiddle AgedNeoplasm MetastasisabirateroneAndrogen AntagonistsAndrostenesBenzamidesenzalutamideNitrilesPhenylthiohydantoinabirateroneenzalutamidemetastatic castration-resistant prostate cancerpharmacoepidemiologyreal worldrecord linkage

Identifiers

PMID32316077
PMCPMC8246935

What OpenQuestion holds

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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.