Evidence map›Paper›PMID 42057197›Full record

ArticleTrials2026

Early secondary outcome analysis in multi-phase randomised-controlled trials, a pragmatic approach: the Healthy Life Trajectories Initiative (HeLTI).

Kalyanaraman Kumaran, Jean-Patrice Baillargeon, Catherine S Birken, Cindy-Lee Dennis, Jianxia Fan, William D Fraser, Hefeng Huang, Rayjean J Hung, Kumar Gavali Suryanarayana, Stephen J Lye and 2 more

Abstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Trials, 2026. 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
–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

1 citing paper in PubMed.

  1. Early insights from the Healthy Life Trajectories Initiative.Bulletin of the World Health Organization · 2026
    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

12 authors.

Kalyanaraman KumaranUniversity of Southampton, Southampton, UK.
Jean-Patrice BaillargeonUniversity of Sherbrooke, Sherbrooke, QC, Canada.
Catherine S BirkenSickKids Research Institute, Toronto, ON, Canada.
Cindy-Lee DennisUniversity of Toronto, Toronto, ON, Canada.
Jianxia FanThe International Peace Maternity & Child Health Hospital, Shanghai Jiao Tong University, Shanghai, China.
William D FraserUniversity of Sherbrooke, Sherbrooke, QC, Canada.
Hefeng HuangZhejiang University School of Medicine, Hangzhou, China.
Rayjean J HungUniversity of Toronto, Toronto, ON, Canada.
Kumar Gavali SuryanarayanaVivekananda Memorial Hospital, Swami Vivekananda Youth Movement, Mysuru, India.
Stephen J LyeUniversity of Toronto, Toronto, ON, Canada.
Shane A NorrisUniversity of Southampton, Southampton, UK.
Stephen G MatthewsUniversity of Toronto, Toronto, ON, Canada. stephen.matthews@utoronto.ca.ORCID http://orcid.org/0000-0002-9654-9940

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe extended time frame of some trials can cause significant challenges in delaying all analyses until the primary outcome is attained. This may particularly affect any mechanistic studies linked to secondary outcomes, as well as impact the involvement of trainees and junior investigators in the project. This manuscript describes the strategy and process by which the leadership of the Healthy Life Trajectories Initiative (HeLTI) developed an analysis approach.

methodsThe study involved the engagement of an expert panel with broad knowledge in disciplines relevant to the study.

resultsSeveral reviewers emphasised the importance of undertaking analysis only after the primary outcome has been achieved. However, the majority of reviewers highlighted that this was not practical in the context of the HeLTI consortium because valuable interim analysis would be missed.

conclusionAfter careful consideration of the issue and feedback received, the HeLTI leadership agreed to an approach that allowed publishing between-group comparisons of secondary outcomes and linked mechanistic studies before the primary outcome, using an a priori agreed phased approach.

Indexed as

Endpoint DeterminationPragmatic Clinical Trials as TopicRandomized Controlled Trials as TopicResearch DesignHumansLeadershipSecondary Data AnalysisTime FactorsClinical trial methodologyClinical trialsTrial analysis

Identifiers

PMID42057197
PMCPMC13274044

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.