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. 2025 Sep 3:390:e087179.
doi: 10.1136/bmj-2025-087179.

Transparent reporting of observational studies emulating a target trial: the TARGET Statement

Aidan G Cashin  1   2 , Harrison J Hansford  1   2 , Miguel A Hernán  3   4   5 , Sonja A Swanson  3   4   6 , Hopin Lee  7   8 , Matthew D Jones  1   2 , Issa J Dahabreh  3   4   5   9 , Barbra A Dickerman  3   4 , Matthias Egger  10   11   12 , Xabier Garcia-Albeniz  3   13 , Robert M Golub  14 , Nazrul Islam  15   16 , Sara Lodi  3   17 , Margarita Moreno-Betancur  18   19 , Sallie-Anne Pearson  20 , Sebastian Schneeweiss  21 , Melissa K Sharp  22 , Jonathan A C Sterne  12   23   24 , Elizabeth A Stuart  25 , James H McAuley  26   2
Affiliations

Transparent reporting of observational studies emulating a target trial: the TARGET Statement

Aidan G Cashin et al. BMJ. .

Abstract

Importance: When randomized trials are unavailable or not feasible, observational studies can be used to answer causal questions about the comparative effects of interventions by attempting to emulate a hypothetical pragmatic randomized trial (target trial). Published guidance to aid reporting of these studies is not available.

Objective: To develop consensus based guidance for reporting observational studies performed to estimate causal effects by explicitly emulating a target trial.

Design, setting, and participants: The Transparent Reporting of Observational Studies Emulating a Target Trial (TARGET) guideline was developed using the Enhancing the Quality and Transparency of Health Research (EQUATOR) framework. The development included (1) a systematic review of reporting practices in published studies that had explicitly aimed to emulate a target trial; (2) a two round online survey (August 2023 to March 2024; 18 expert participants from six countries) to assess the importance of candidate items selected from previous research and to identify additional items; (3) a three day, expert consensus meeting (June 2024; 18 panelists) to refine the scope of the guideline and draft the checklist; and (4) pilot of the draft checklist with stakeholders (n=108; September 2024 to February 2025). The checklist was further refined based on feedback on successive drafts.

Findings: The 21-item TARGET checklist is organized into six sections (abstract, introduction, methods, results, discussion, other information). TARGET provides guidance for reporting observational studies of interventions explicitly emulating a parallel group, individually randomized target trial, with adjustment for baseline confounders. Key recommendations are to (1) identify the study as an observational emulation of a target trial; (2) summarize the causal question and reason for emulating a target trial; (3) clearly specify the target trial protocol (ie, the causal estimand, identifying assumptions, data analysis plan) and how it was mapped to the observational data; and (4) report the estimate obtained for each causal estimand, its precision, and findings from additional analyses to assess the sensitivity of the estimates to assumptions, and design and analysis choices.

Conclusions and relevance: Application of the TARGET guideline recommendations aims to improve reporting transparency and peer review and help researchers, clinicians, and other readers interpret and apply the results.

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Conflict of interest statement

Competing interests: All authors have completed the ICMJE uniform disclosure form at www.icmje.org/disclosure-of-interest/ and declare: no support from any organization for the submitted work. HJH reported receiving grants from Neuroscience Research Australia and the Australian National Health and Medical Research Council during the conduct of the study. MAH reported receiving consulting fees from Adigens Health; owning equity in Adigens Health; and receiving personal fees from ADIA Laboratory outside the submitted work. IJD reported receiving grants from the Patient-Centered Outcomes Research Institute (PCORI) and the National Heart, Lung, and Blood Institute during the conduct of the study and receiving personal fees from the American Medical Association/JAMA for serving as a JAMA statistical editor outside the submitted work. BAD reported receiving grants from the National Institutes of Health/National Cancer Institute during the conduct of the study. MM-B reported receiving grants from Australian National Health and Medical Research Council (Investigator Grant 2009572) during the conduct of the study. SS reported receiving grants from UCB Pharma and Bayer Pharma and receiving consulting fees from Aetion Inc outside the submitted work. EAS reported receiving grants from PCORI (ME-2020C3-21145) and National Institute of Mental Health (R01MH126856) during the conduct of the study; receiving personal fees from the American Medical Association as JAMA Health Forum statistical editor; and receiving personal fees from Eli Lilly outside the submitted work. No other disclosures were reported. NI is a research editor at The BMJ. Provenance and peer review: Not commissioned; externally peer reviewed by JAMA.

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