Observational Study

. 2023 Sep 12;13(9):e074626.

doi: 10.1136/bmjopen-2023-074626.

Development of the TrAnsparent ReportinG of observational studies Emulating a Target trial (TARGET) guideline

Harrison J Hansford^{1

2}, Aidan G Cashin^{3

2}, Matthew D Jones^{3

2}, Sonja A Swanson^{4

5

6}, Nazrul Islam^{7

8}, Issa J Dahabreh^{5

6

9}, Barbra A Dickerman^{5

6}, Matthias Egger^{10

11

12}, Xavier Garcia-Albeniz^{5

13}, Robert M Golub¹⁴, Sara Lodi^{5

15}, Margarita Moreno-Betancur^{16

17}, Sallie-Anne Pearson¹⁸, Sebastian Schneeweiss¹⁹, Jonathan Sterne^{20

21

22}, Melissa K Sharp²³, Elizabeth A Stuart²⁴, Miguel A Hernan^{5

6

9}, Hopin Lee^{25

26}, James H McAuley^{3

2}

Affiliations

¹ School of Health Sciences, Faculty of Medicine and Health, UNSW Sydney, Sydney, New South Wales, Australia h.hansford@unsw.edu.au.
² Centre for Pain IMPACT, Neuroscience Research Australia, Randwick, New South Wales, Australia.
³ School of Health Sciences, Faculty of Medicine and Health, UNSW Sydney, Sydney, New South Wales, Australia.
⁴ Department of Epidemiology, University of Pittsburgh, Pittsburgh, Pennsylvania, USA.
⁵ CAUSALab, Harvard T.H. Chan School of Public Health, Boston, Massachusetts, USA.
⁶ Department of Epidemiology, Harvard T.H. Chan School of Public Health, Boston, Massachusetts, USA.
⁷ Oxford Population Health, Big Data Institute, University of Oxford, Oxford, UK.
⁸ Faculty of Medicine, University of Southampton, Southampton, UK.
⁹ Department of Biostatistics, Harvard T.H. Chan School of Public Health, Boston, Massachusetts, USA.
¹⁰ Institute of Social & Preventive Medicine, University of Bern, Bern, Switzerland.
¹¹ Centre for Infectious Disease Epidemiology and Research, University of Cape Town Faculty of Health Sciences, Observatory, Western Cape, South Africa.
¹² Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK.
¹³ RTI Health Solutions Barcelona, Barcelona, Catalunya, Spain.
¹⁴ Department of Medicine, Northwestern University Feinberg School of Medicine, Chicago, Illinois, USA.
¹⁵ Department of Biostatistics, Boston University School of Public Health, Boston, Massachusetts, USA.
¹⁶ Clinical Epidemiology & Biostatistics Unit, Murdoch Children's Research Institute, Melbourne, Victoria, Australia.
¹⁷ Department of Paediatrics, The University of Melbourne, Melbourne, Victoria, Australia.
¹⁸ School of Population Health, Faculty of Medicine and Health, UNSW Sydney, Sydney, New South Wales, Australia.
¹⁹ Division of Pharmacoepidemiology, Department of Medicine, Brigham & Women's Hospital, Harvard Medical School, Boston, Massachusetts, USA.
²⁰ Department of Population Health Sciences, University of Bristol, Bristol, UK.
²¹ NIHR Bristol Biomedical Research Centre, Bristol, UK.
²² Health Data Research UK South-West, Bristol, UK.
²³ Department of Public Health and Epidemiology, RCSI University of Medicine and Health Sciences, Dublin, Ireland.
²⁴ Department of Biostatistics, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA.
²⁵ University of Exeter Medical School, Exeter, UK.
²⁶ EMEA Methods and Evidence Generation, IQVIA London, London, UK.

PMID: 37699620
PMCID: PMC10503363
DOI: 10.1136/bmjopen-2023-074626

Observational Study

Development of the TrAnsparent ReportinG of observational studies Emulating a Target trial (TARGET) guideline

Harrison J Hansford et al. BMJ Open. 2023.

. 2023 Sep 12;13(9):e074626.

doi: 10.1136/bmjopen-2023-074626.

Authors

Affiliations

¹ School of Health Sciences, Faculty of Medicine and Health, UNSW Sydney, Sydney, New South Wales, Australia h.hansford@unsw.edu.au.
² Centre for Pain IMPACT, Neuroscience Research Australia, Randwick, New South Wales, Australia.
³ School of Health Sciences, Faculty of Medicine and Health, UNSW Sydney, Sydney, New South Wales, Australia.
⁴ Department of Epidemiology, University of Pittsburgh, Pittsburgh, Pennsylvania, USA.
⁵ CAUSALab, Harvard T.H. Chan School of Public Health, Boston, Massachusetts, USA.
⁶ Department of Epidemiology, Harvard T.H. Chan School of Public Health, Boston, Massachusetts, USA.
⁷ Oxford Population Health, Big Data Institute, University of Oxford, Oxford, UK.
⁸ Faculty of Medicine, University of Southampton, Southampton, UK.
⁹ Department of Biostatistics, Harvard T.H. Chan School of Public Health, Boston, Massachusetts, USA.
¹⁰ Institute of Social & Preventive Medicine, University of Bern, Bern, Switzerland.
¹¹ Centre for Infectious Disease Epidemiology and Research, University of Cape Town Faculty of Health Sciences, Observatory, Western Cape, South Africa.
¹² Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK.
¹³ RTI Health Solutions Barcelona, Barcelona, Catalunya, Spain.
¹⁴ Department of Medicine, Northwestern University Feinberg School of Medicine, Chicago, Illinois, USA.
¹⁵ Department of Biostatistics, Boston University School of Public Health, Boston, Massachusetts, USA.
¹⁶ Clinical Epidemiology & Biostatistics Unit, Murdoch Children's Research Institute, Melbourne, Victoria, Australia.
¹⁷ Department of Paediatrics, The University of Melbourne, Melbourne, Victoria, Australia.
¹⁸ School of Population Health, Faculty of Medicine and Health, UNSW Sydney, Sydney, New South Wales, Australia.
¹⁹ Division of Pharmacoepidemiology, Department of Medicine, Brigham & Women's Hospital, Harvard Medical School, Boston, Massachusetts, USA.
²⁰ Department of Population Health Sciences, University of Bristol, Bristol, UK.
²¹ NIHR Bristol Biomedical Research Centre, Bristol, UK.
²² Health Data Research UK South-West, Bristol, UK.
²³ Department of Public Health and Epidemiology, RCSI University of Medicine and Health Sciences, Dublin, Ireland.
²⁴ Department of Biostatistics, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA.
²⁵ University of Exeter Medical School, Exeter, UK.
²⁶ EMEA Methods and Evidence Generation, IQVIA London, London, UK.

PMID: 37699620
PMCID: PMC10503363
DOI: 10.1136/bmjopen-2023-074626

Abstract

Background: Observational studies are increasingly used to inform health decision-making when randomised trials are not feasible, ethical or timely. The target trial approach provides a framework to help minimise common biases in observational studies that aim to estimate the causal effect of interventions. Incomplete reporting of studies using the target trial framework limits the ability for clinicians, researchers, patients and other decision-makers to appraise, synthesise and interpret findings to inform clinical and public health practice and policy. This paper describes the methods that we will use to develop the TrAnsparent ReportinG of observational studies Emulating a Target trial (TARGET) reporting guideline.

Methods/design: The TARGET reporting guideline will be developed in five stages following recommended guidance. The first stage will identify target trial reporting practices by systematically reviewing published studies that explicitly emulated a target trial. The second stage will identify and refine items to be considered for inclusion in the TARGET guideline by consulting content experts using sequential online surveys. The third stage will prioritise and consolidate key items to be included in the TARGET guideline at an in-person consensus meeting of TARGET investigators. The fourth stage will produce and pilot-test both the TARGET guideline and explanation and elaboration document with relevant stakeholders. The fifth stage will disseminate the TARGET guideline and resources via journals, conferences and courses.

Ethics and dissemination: Ethical approval for the survey has been attained (HC220536). The TARGET guideline will be disseminated widely in partnership with stakeholders to maximise adoption and improve reporting of these studies.

Keywords: EPIDEMIOLOGY; Retrospective Studies; STATISTICS & RESEARCH METHODS.

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Conflict of interest statement

Competing interests: None declared.

Figures

**Figure 1**
Elements relevant to both the specification and emulation of the target trial described by Hernán and Robins.

**Figure 2**
Workflow for the development of the TARGET guideline. TARGET, TrAnsparent ReportinG of studies Emulating a Target trial.

See this image and copyright information in PMC

References

1. Hernán MA, Sauer BC, Hernández-Díaz S, et al. . Specifying a target trial prevents immortal time bias and other self-inflicted injuries in observational analyses. J Clin Epidemiol 2016;79:70–5. 10.1016/j.jclinepi.2016.04.014 - DOI - PMC - PubMed
1. Dickerman BA, García-Albéniz X, Logan RW, et al. . Avoidable flaws in observational analyses: an application to Statins and cancer. Nat Med 2019;25:1601–6. 10.1038/s41591-019-0597-x - DOI - PMC - PubMed
1. Hernán MA, Robins JM. Using big data to emulate a target trial when a randomized trial is not available. Am J Epidemiol 2016;183:758–64. 10.1093/aje/kwv254 - DOI - PMC - PubMed
1. Hernán MA. Methods of public health research—strengthening causal inference from observational data. N Engl J Med 2021;385:1345–8. 10.1056/NEJMp2113319 - DOI - PubMed
1. Cochran WG. Observational studies. Observational Studies 2015;1:126–36. 10.1353/obs.2015.0010 - DOI

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Development of the TrAnsparent ReportinG of observational studies Emulating a Target trial (TARGET) guideline

Affiliations

Development of the TrAnsparent ReportinG of observational studies Emulating a Target trial (TARGET) guideline

Authors

Affiliations

Abstract

Conflict of interest statement

Figures

References

Publication types

MeSH terms

Grants and funding

LinkOut - more resources

Full Text Sources