Few randomized trials in preterm birth prevention meet predefined usefulness criteria

Janneke van ‘t Hooft; Charlotte E. van Dijk; Cathrine Axfors; Zarko Alfirevic; Martijn A. Oudijk; Ben W.J. Mol; Patrick M. Bossuyt; John P.A. Ioannidis

doi:10.1016/j.jclinepi.2023.08.016

Few randomized trials in preterm birth prevention meet predefined usefulness criteria

Janneke van ‘t Hooft^*, Charlotte E. van Dijk, Cathrine Axfors, Zarko Alfirevic, Martijn A. Oudijk, Ben W.J. Mol, Patrick M. Bossuyt, John P.A. Ioannidis

^*Corresponding author for this work

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Abstract

Objectives: We operationalized a research usefulness tool identified through literature searches and consensus and examined if randomized controlled trials (RCTs) addressing preterm birth prevention met predefined criteria for usefulness. Study Design and Setting: The usefulness tool included eight criteria combining 13 items. RCTs were evaluated for compliance with each item by multiple assessors (reviewer agreement 95–98%). Proportions of compliances with 95% confidence interval (CI) were calculated and change over time was assessed using ≧ 2010 as a cutoff. Results: Among 347 selected RCTs, published within 56 preterm birth Cochrane reviews, only 36 (10%, 95% CI = 7–14%) met more than half of the usefulness criteria. Compared to trials before 2010, recent trials used composite or surrogate (less informative) outcomes more often (13% vs. 25%, relative risk 1.91, 95% CI = 1.21–3.00). Only 16 trials reflected real practice (pragmatism) in design (5%, 95% CI = 3–7%), with no improvements over time. No trials reported involvement of mothers to reflect patients’ research priorities and outcomes selection. Recent trials were more transparent. Conclusion: Few preterm birth prevention RCTs met more than half of the usefulness criteria but most of usefulness criteria are improving after 2010. Use of informative outcomes, patient centeredness, pragmatism and transparency should be key targets for future research planning.

Original language	English
Pages (from-to)	107-117
Number of pages	11
Journal	Journal of Clinical Epidemiology
Volume	162
Early online date	21 Sept 2023
DOIs	https://doi.org/10.1016/j.jclinepi.2023.08.016
Publication status	Published - Oct 2023

Bibliographical note

Funding Information:
Funding: The study was funded by a grant from the Netherlands Organization for Health Research and Development (ZonMw Rubicon grand #452182306). The funder had no involvement in any phase of this study.
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 postdoctoral grant from the Netherlands Organization for Health Research and Development (Rubicon grand 452,182,306). C.A. is supported by postdoctoral grants from the Knut and Alice Wallenberg Foundation (K.A.W. 2019.0561), Uppsala University, and the Sweden-America Foundation. B.M. is supported by an NHMRC Investigator grant (GNT1176437). B.M. reports consultancy for Guerbet, has been a member of the ObsEva advisory board and holds Stock options for ObsEva. The work of J.I. has been supported by an unrestricted gift from Sue and Bob O'Donnell. J.I. is a team member of the editorial board of JCE.

Publisher Copyright:
© 2023 The Authors

Keywords

Clinical research
Pragmatism
Preterm birth
Randomized controlled trials
Transparency
Usefulness

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Cite this

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title = "Few randomized trials in preterm birth prevention meet predefined usefulness criteria",

abstract = "Objectives: We operationalized a research usefulness tool identified through literature searches and consensus and examined if randomized controlled trials (RCTs) addressing preterm birth prevention met predefined criteria for usefulness. Study Design and Setting: The usefulness tool included eight criteria combining 13 items. RCTs were evaluated for compliance with each item by multiple assessors (reviewer agreement 95–98%). Proportions of compliances with 95% confidence interval (CI) were calculated and change over time was assessed using ≧ 2010 as a cutoff. Results: Among 347 selected RCTs, published within 56 preterm birth Cochrane reviews, only 36 (10%, 95% CI = 7–14%) met more than half of the usefulness criteria. Compared to trials before 2010, recent trials used composite or surrogate (less informative) outcomes more often (13% vs. 25%, relative risk 1.91, 95% CI = 1.21–3.00). Only 16 trials reflected real practice (pragmatism) in design (5%, 95% CI = 3–7%), with no improvements over time. No trials reported involvement of mothers to reflect patients{\textquoteright} research priorities and outcomes selection. Recent trials were more transparent. Conclusion: Few preterm birth prevention RCTs met more than half of the usefulness criteria but most of usefulness criteria are improving after 2010. Use of informative outcomes, patient centeredness, pragmatism and transparency should be key targets for future research planning.",

keywords = "Clinical research, Pragmatism, Preterm birth, Randomized controlled trials, Transparency, Usefulness",

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

note = "Funding Information: Funding: The study was funded by a grant from the Netherlands Organization for Health Research and Development (ZonMw Rubicon grand #452182306). The funder had no involvement in any phase of this study. 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 postdoctoral grant from the Netherlands Organization for Health Research and Development (Rubicon grand 452,182,306). C.A. is supported by postdoctoral grants from the Knut and Alice Wallenberg Foundation (K.A.W. 2019.0561), Uppsala University, and the Sweden-America Foundation. B.M. is supported by an NHMRC Investigator grant (GNT1176437). B.M. reports consultancy for Guerbet, has been a member of the ObsEva advisory board and holds Stock options for ObsEva. The work of J.I. has been supported by an unrestricted gift from Sue and Bob O'Donnell. J.I. is a team member of the editorial board of JCE. Publisher Copyright: {\textcopyright} 2023 The Authors",

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AU - van Dijk, Charlotte E.

AU - Axfors, Cathrine

AU - Alfirevic, Zarko

AU - Oudijk, Martijn A.

AU - Mol, Ben W.J.

AU - Bossuyt, Patrick M.

AU - Ioannidis, John P.A.

N1 - Funding Information: Funding: The study was funded by a grant from the Netherlands Organization for Health Research and Development (ZonMw Rubicon grand #452182306). The funder had no involvement in any phase of this study. 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 postdoctoral grant from the Netherlands Organization for Health Research and Development (Rubicon grand 452,182,306). C.A. is supported by postdoctoral grants from the Knut and Alice Wallenberg Foundation (K.A.W. 2019.0561), Uppsala University, and the Sweden-America Foundation. B.M. is supported by an NHMRC Investigator grant (GNT1176437). B.M. reports consultancy for Guerbet, has been a member of the ObsEva advisory board and holds Stock options for ObsEva. The work of J.I. has been supported by an unrestricted gift from Sue and Bob O'Donnell. J.I. is a team member of the editorial board of JCE. Publisher Copyright: © 2023 The Authors

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N2 - Objectives: We operationalized a research usefulness tool identified through literature searches and consensus and examined if randomized controlled trials (RCTs) addressing preterm birth prevention met predefined criteria for usefulness. Study Design and Setting: The usefulness tool included eight criteria combining 13 items. RCTs were evaluated for compliance with each item by multiple assessors (reviewer agreement 95–98%). Proportions of compliances with 95% confidence interval (CI) were calculated and change over time was assessed using ≧ 2010 as a cutoff. Results: Among 347 selected RCTs, published within 56 preterm birth Cochrane reviews, only 36 (10%, 95% CI = 7–14%) met more than half of the usefulness criteria. Compared to trials before 2010, recent trials used composite or surrogate (less informative) outcomes more often (13% vs. 25%, relative risk 1.91, 95% CI = 1.21–3.00). Only 16 trials reflected real practice (pragmatism) in design (5%, 95% CI = 3–7%), with no improvements over time. No trials reported involvement of mothers to reflect patients’ research priorities and outcomes selection. Recent trials were more transparent. Conclusion: Few preterm birth prevention RCTs met more than half of the usefulness criteria but most of usefulness criteria are improving after 2010. Use of informative outcomes, patient centeredness, pragmatism and transparency should be key targets for future research planning.

AB - Objectives: We operationalized a research usefulness tool identified through literature searches and consensus and examined if randomized controlled trials (RCTs) addressing preterm birth prevention met predefined criteria for usefulness. Study Design and Setting: The usefulness tool included eight criteria combining 13 items. RCTs were evaluated for compliance with each item by multiple assessors (reviewer agreement 95–98%). Proportions of compliances with 95% confidence interval (CI) were calculated and change over time was assessed using ≧ 2010 as a cutoff. Results: Among 347 selected RCTs, published within 56 preterm birth Cochrane reviews, only 36 (10%, 95% CI = 7–14%) met more than half of the usefulness criteria. Compared to trials before 2010, recent trials used composite or surrogate (less informative) outcomes more often (13% vs. 25%, relative risk 1.91, 95% CI = 1.21–3.00). Only 16 trials reflected real practice (pragmatism) in design (5%, 95% CI = 3–7%), with no improvements over time. No trials reported involvement of mothers to reflect patients’ research priorities and outcomes selection. Recent trials were more transparent. Conclusion: Few preterm birth prevention RCTs met more than half of the usefulness criteria but most of usefulness criteria are improving after 2010. Use of informative outcomes, patient centeredness, pragmatism and transparency should be key targets for future research planning.

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ER -

Few randomized trials in preterm birth prevention meet predefined usefulness criteria

Abstract

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Keywords

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