Evidence map›Paper›PMID 36228332›Full record

SynthesisESMO open2022

Subgroup analyses in randomized phase III trials of systemic treatments in patients with advanced solid tumours: a systematic review of trials published between 2017 and 2020.

C Paratore, C Zichi, M Audisio, M Bungaro, A Caglio, R Di Liello, T Gamba, P Gargiulo, A Mariniello, M L Reale and 2 more

Open access · goldAbstract readSystematic Review
In one paragraph

Synthesis in ESMO open, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed, 1 pooled it
0.5field-weighted citation impact, top 42% 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

5 citing papers in PubMed, 1 synthesis or guideline pooled it, 6 citations in OpenAlex.

  1. Pooled it
  2. Article
  3. Article
  4. Article
  5. Review
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

12 authors at 4 institutions in 2 countries.

C ParatoreDepartment of Oncology, University of Turin, San Luigi Gonzaga Hospital, Orbassano, Turin, Italy; Department of Oncology, University of Turin, Ordine Mauriziano Hospital, Turin, Italy.
C ZichiDepartment of Oncology, University of Turin, Ordine Mauriziano Hospital, Turin, Italy.
M AudisioDepartment of Oncology, University of Turin, San Luigi Gonzaga Hospital, Orbassano, Turin, Italy.
M BungaroDepartment of Oncology, University of Turin, San Luigi Gonzaga Hospital, Orbassano, Turin, Italy.
A CaglioDepartment of Oncology, University of Turin, Ordine Mauriziano Hospital, Turin, Italy.
R Di LielloClinical Trials Unit, Istituto Nazionale Tumori - IRCCS - Fondazione Giovanni Pascale, Naples, Italy.
T GambaDepartment of Oncology, University of Turin, Ordine Mauriziano Hospital, Turin, Italy.
P GargiuloClinical Trials Unit, Istituto Nazionale Tumori - IRCCS - Fondazione Giovanni Pascale, Naples, Italy.
A MarinielloDepartment of Oncology, University of Turin, San Luigi Gonzaga Hospital, Orbassano, Turin, Italy; Emory Vaccine Center, Emory University School of Medicine, Atlanta, USA.
M L RealeDepartment of Oncology, University of Turin, San Luigi Gonzaga Hospital, Orbassano, Turin, Italy.
F PerroneClinical Trials Unit, Istituto Nazionale Tumori - IRCCS - Fondazione Giovanni Pascale, Naples, Italy.
M Di MaioDepartment of Oncology, University of Turin, Ordine Mauriziano Hospital, Turin, Italy. Electronic address: massimo.dimaio@unito.it.
A. O. Ordine Mauriziano di Torino · ITIstituto Nazionale Tumori IRCCS "Fondazione G. Pascale" · ITOspedale San Luigi Gonzaga · ITEmory University · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundSubgroup analyses of randomized controlled trials are very common in oncology; nevertheless, the methodological approach has not been systematically evaluated. The present analysis was conducted with the aim of describing the prevalence and methodological characteristics of the subgroup analyses in randomized controlled trials in patients with advanced cancer.

methodsA systematic literature search using PubMed was carried out to identify all phase III randomized controlled trials conducted in adult patients affected by locally advanced or metastatic solid tumours, published between 2017 and 2020.

resultsOverall, 253 publications were identified. Subgroup analyses were reported in 217 (86%) publications. A statistically significant association of presence of subgroup analysis with study sponsor was observed: subgroup analyses were reported in 157 (94%) for-profit trials compared with 60 (70%) non-profit trials (P < 0.001). Description of the methodology of subgroup analysis was completely lacking in 82 trials (38%), only cited without methodological details in 100 trials (46%) and fully described in 35 trials (16%). Forest plot of subgroup analyses for the primary endpoint was available in 195 publications (77%). Among publications with reported forest plots, the median number of subgroups for primary endpoint was 19 (range 6-78). Out of the 217 publications with subgroup analyses, authors discuss the heterogeneity of treatment effect among different subgroups in 173 publications (80%), although a formal test for interaction for subgroup analysis of primary endpoint was reported for at least one variable only in 60 publications (28%). Correction for multiplicity was explicitly carried out only in nine trials (4%).

conclusionsThe very high prevalence of subgroup analyses in published papers, together with their methodological weaknesses, makes advisable an adequate education about their correct presentation and correct reading. More attention about proper planning and conduction of subgroup analysis should be paid not only by readers, but also by authors, journal editors and reviewers.

Indexed as

NeoplasmsAdultClinical Trials, Phase III as TopicHumansMedical OncologyRandomized Controlled Trials as Topicadvanced solid tumoursheterogeneity of treatment effectmethodologysubgroup analysessystematic review

Identifiers

PMID36228332
PMCPMC9808470
OpenAlexW4304633962

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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.