Assessing the usefulness of randomised trials in obstetrics and gynaecology

Janneke van ’t Hooft; Charlotte E. van Dijk; Cathrine Axfors; Zarko Alfirevic; Martijn A. Oudijk; Khalid S. Khan; Ben W. J. Mol; Patrick M. Bossuyt; John P. A. Ioannidis

doi:https://doi.org/10.1111/1471-0528.17411

Assessing the usefulness of randomised trials in obstetrics and gynaecology

Janneke van ’t Hooft, Charlotte E. van Dijk, Cathrine Axfors, Zarko Alfirevic, Martijn A. Oudijk, Khalid S. Khan, Ben W. J. Mol, Patrick M. Bossuyt, John P. A. Ioannidis

Research output: Contribution to journal › Comment/Letter to the editor › Academic

4 Citations (Scopus)

Original language	English
Pages (from-to)	695-701
Number of pages	7
Journal	BJOG: An International Journal of Obstetrics and Gynaecology
Volume	130
Issue number	7
Early online date	2023
DOIs	https://doi.org/10.1111/1471-0528.17411
Publication status	Published - Jun 2023

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@article{e92ed3be0b154af2942aa861c0a24578,

title = "Assessing the usefulness of randomised trials in obstetrics and gynaecology",

author = "Janneke van {\textquoteright}t Hooft and {van Dijk}, {Charlotte E.} and Cathrine Axfors and Zarko Alfirevic and Oudijk, {Martijn A.} and Khan, {Khalid S.} and Mol, {Ben W. J.} and Bossuyt, {Patrick M.} and Ioannidis, {John P. A.}",

note = "Funding Information: The study was funded by a grant from the Netherlands Organization for Health Research and Development (ZonMw Rubicon grant #452182306). The funder had no involvement in any phase of this study. Funding Information: Useful clinical research considers the value of the information under investigation at the design and planing phase of the study. How much can we learn from the study and does this offset the cost of performing it? Especially in an era of limited resources, a value‐of‐information analysis or budget impact calculation is useful before starting the trial. A value‐of‐information analysis is a method to provide insights on the expected benefits from clinical research by characterising the uncertainty of the effects of interventions on health outcomes. This information is then used to inform decisions about the design and priority of those studies. A budget impact calculation estimates a difference in healthcare costs before and after implementing the research findings (in case they were found to be effective). Both value‐of‐information and budget impact analyses can be performed when designing a trial, and therefore crucially differ from cost‐effectiveness analysis (performed after knowing study results). Funders like ZonMw in the Netherlands and the National Institute for Health and Care Research (NIHR) in the UK ask for budget impact analysis in the grant applications. Presenting this information to ethics committees and also in the protocol of a final article can help to raise awareness about the resources invested to target a specific health problem. 32,33 32 33 Funding Information: Meta‐Research Innovation Center at Stanford (METRICS), Stanford University, is supported by a grant from the Laura and John Arnold Foundation. JvtH is supported by a postdoctoral grant from the Netherlands Organization for Health Research and Development (Rubicon grant 452182306). CA is supported by postdoctoral grants from the Knut and Alice Wallenberg Foundation (KAW 2019.0561), Uppsala University, and the Sweden–America Foundation. BWJM is supported by a National Health and Medical Research Council (NHMRC) investigator grant (GNT1176437). BWJM reports consultancy for Guerbet, has been a member of the ObsEva advisory board and holds stock options for ObsEva. The work of JPAI has been supported by an unrestricted gift from Sue and Bob O'Donnell. All the funders mentioned above had no role in the study design, data collection and analysis, decision to publish, or preparation of the article. Completed disclosure of interests form available to view online as supporting information.",

year = "2023",

month = jun,

doi = "https://doi.org/10.1111/1471-0528.17411",

language = "English",

volume = "130",

pages = "695--701",

journal = "BJOG: An International Journal of Obstetrics and Gynaecology",

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publisher = "Wiley-Blackwell",

number = "7",

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TY - JOUR

T1 - Assessing the usefulness of randomised trials in obstetrics and gynaecology

AU - van ’t Hooft, Janneke

AU - van Dijk, Charlotte E.

AU - Axfors, Cathrine

AU - Alfirevic, Zarko

AU - Oudijk, Martijn A.

AU - Khan, Khalid S.

AU - Mol, Ben W. J.

AU - Bossuyt, Patrick M.

AU - Ioannidis, John P. A.

N1 - Funding Information: The study was funded by a grant from the Netherlands Organization for Health Research and Development (ZonMw Rubicon grant #452182306). The funder had no involvement in any phase of this study. Funding Information: Useful clinical research considers the value of the information under investigation at the design and planing phase of the study. How much can we learn from the study and does this offset the cost of performing it? Especially in an era of limited resources, a value‐of‐information analysis or budget impact calculation is useful before starting the trial. A value‐of‐information analysis is a method to provide insights on the expected benefits from clinical research by characterising the uncertainty of the effects of interventions on health outcomes. This information is then used to inform decisions about the design and priority of those studies. A budget impact calculation estimates a difference in healthcare costs before and after implementing the research findings (in case they were found to be effective). Both value‐of‐information and budget impact analyses can be performed when designing a trial, and therefore crucially differ from cost‐effectiveness analysis (performed after knowing study results). Funders like ZonMw in the Netherlands and the National Institute for Health and Care Research (NIHR) in the UK ask for budget impact analysis in the grant applications. Presenting this information to ethics committees and also in the protocol of a final article can help to raise awareness about the resources invested to target a specific health problem. 32,33 32 33 Funding Information: Meta‐Research Innovation Center at Stanford (METRICS), Stanford University, is supported by a grant from the Laura and John Arnold Foundation. JvtH is supported by a postdoctoral grant from the Netherlands Organization for Health Research and Development (Rubicon grant 452182306). CA is supported by postdoctoral grants from the Knut and Alice Wallenberg Foundation (KAW 2019.0561), Uppsala University, and the Sweden–America Foundation. BWJM is supported by a National Health and Medical Research Council (NHMRC) investigator grant (GNT1176437). BWJM reports consultancy for Guerbet, has been a member of the ObsEva advisory board and holds stock options for ObsEva. The work of JPAI has been supported by an unrestricted gift from Sue and Bob O'Donnell. All the funders mentioned above had no role in the study design, data collection and analysis, decision to publish, or preparation of the article. Completed disclosure of interests form available to view online as supporting information.

PY - 2023/6

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U2 - https://doi.org/10.1111/1471-0528.17411

DO - https://doi.org/10.1111/1471-0528.17411

M3 - Comment/Letter to the editor

C2 - 36696225

SN - 1470-0328

VL - 130

SP - 695

EP - 701

JO - BJOG: An International Journal of Obstetrics and Gynaecology

JF - BJOG: An International Journal of Obstetrics and Gynaecology

IS - 7

ER -

Assessing the usefulness of randomised trials in obstetrics and gynaecology

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