Evidence map›Paper›PMID 37729597›Full record

ArticleJCO clinical cancer informatics2023

Real-World Pitfalls of Analyzing Real-World Data: A Cautionary Note and Path Forward.

John D Cooper, Karen Shou, Kevin Sunderland, Kevin Pham, Jennifer A Thornton, Christin B DeStefano

Abstract read
In one paragraph

Article in JCO clinical cancer informatics, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing 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

3 citing papers in PubMed.

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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

6 authors.

John D CooperWalter Reed National Military Medical Center, Bethesda, MD.
Karen ShouWalter Reed National Military Medical Center, Bethesda, MD.ORCID 0000-0002-9935-628X
Kevin SunderlandClinical Investigation Facility, David Grant USAF Medical Center, Fairfield, CA.ORCID 0000-0001-7059-851X
Kevin PhamClinical Investigation Facility, David Grant USAF Medical Center, Fairfield, CA.ORCID 0000-0002-4223-5620
Jennifer A ThorntonClinical Investigation Facility, David Grant USAF Medical Center, Fairfield, CA.
Christin B DeStefanoWalter Reed National Military Medical Center, Bethesda, MD.ORCID 0000-0002-8890-7760

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeReal-world data (RWD) are pervasive in oncology research and offer insights into clinical trends and patient outcomes. However, RWD have shortcomings, making them prone to pitfalls during survival analyses. The American Society of Clinical Oncology (ASCO) CancerLinQ Discovery (CLQD) multiple myeloma (MM) data set was used to demonstrate some common pitfalls when analyzing survival from RWD: using incorrect surrogate markers for missing data and/or classification errors, ignoring deaths at time zero, and failing to account for guarantee-time bias.

methodsThe ASCO CLQD MM data set (July 19, 2021, release) was used to compare overall survival (OS) in patients with a known versus presumed date of MM diagnosis, in patients with secondary AML (sAML) with early deaths (ie, 0 months) included versus dropped, and in patients with second primary malignancies (SPMs) matched versus unmatched to control for time-related confounding factors (ie, guarantee-time bias). Analyses were conducted using STATA Version 17.0 (College Station, TX).

resultsIn the CLQD MM data set, 28% of patients were missing a diagnosis date. Attempts to use the presumed diagnosis date (ie, first bortezomib or lenalidomide administration) as a surrogate marker for missing diagnosis dates were not successful as median OS was significantly different in patients with a recorded versus presumed diagnosis date (107

conclusionTo fully maximize the benefits of RWD in oncology research, clinicians must be aware of analytic methods that can overcome pitfalls in survival analyses.

Indexed as

Medical OncologyMultiple MyelomaBortezomibHumansLenalidomideTime FactorsBortezomibLenalidomide

Identifiers

PMID37729597
PMCPMC10569773

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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.