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Quality of stepped-wedge trial reporting can be reliably assessed using an updated CONSORT: crowd-sourcing systematic review

Quality of stepped-wedge trial reporting can be reliably assessed using an updated CONSORT: crowd-sourcing systematic review
Quality of stepped-wedge trial reporting can be reliably assessed using an updated CONSORT: crowd-sourcing systematic review

Objectives: The Consolidated Standards of Reporting Trials extension for the stepped-wedge cluster randomized trial (SW-CRT) is a recently published reporting guideline for SW-CRTs. We assess the quality of reporting of a recent sample of SW-CRTs. Study Design and Setting: Quality of reporting was asssessed according to the 26 items in the new guideline using a novel crowd sourcing methodology conducted independently and in duplicate, with random assignment, by 50 reviewers. We assessed reliability of the quality assessments, proposing this as a novel way to assess robustness of items in reporting guidelines. Results: Several items were well reported. Some items were very poorly reported, including several items that have unique requirements for the SW-CRT, such as the rationale for use of the design, description of the design, identification and recruitment of participants within clusters, and concealment of cluster allocation (not reported in more than 50% of the reports). Agreement across items was moderate (median percentage agreement was 76% [IQR 64 to 86]). Agreement was low for several items including the description of the trial design and why trial ended or stopped for example. Conclusions: When reporting SW-CRTs, authors should pay particular attention to ensure clear reporting on the exact format of the design with justification, as well as how clusters and individuals were identified for inclusion in the study, and whether this was done before or after randomization of the clusters, which are crucial for risk of bias assessments. Some items, including why the trial ended, might either not be relevant to SW-CRTs or might be unclearly described in the statement.

CONSORT, Quality of reporting, Reliability, Stepped-wedge cluster randomized trial
0895-4356
77-88
Hemming, Karla
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Carroll, Kelly
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Thompson, Jennifer
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Forbes, Andrew
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Taljaard, Monica
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Dutton, Susan J.
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Madurasinghe, Vichithranie
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Morgan, Katy
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Stuart, Beth
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Fielding, Katherine
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Cornelius, Victoria
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Turner, Elizabeth L.
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Hooper, Richard
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Giraudeau, Bruno
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Seed, Paul T.
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Nickless, Alecia
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Grayling, Michael
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Prague, Melanie
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Bell, Lauren
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Watson, Eila
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Gafoor, Rafael
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Marlin, Nadine
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Yorganci, Emel
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Smith, Lesley
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Mbekwe, Murielle
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Teerenstra, Steven
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Chan, Claire
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Moerbeek, Mirjam
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Jacobsen, Pamela
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Bond, Simon
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Jones, Ben
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Preisser, John
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Kanaan, Mona
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Hewitt, Catherine
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Easter, Christina
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Pellatt-Higgins, Tracy
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Pankhurst, Laura
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Agbla, Schadrac C.
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Eldridge, Sandra
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Lerner, Robin G.
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Leyrat, Clémence
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Pilling, Mark
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Forman, Julia R.
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Bhattacharya, Indrani
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Magill, Nicholas
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Candlish, Jane
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McDowell, Cliona
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Martin, James
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Kristunas, Caroline
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The SW-CRT Review Group
Hemming, Karla
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Carroll, Kelly
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Thompson, Jennifer
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Forbes, Andrew
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Taljaard, Monica
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Dutton, Susan J.
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Madurasinghe, Vichithranie
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Morgan, Katy
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Stuart, Beth
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Fielding, Katherine
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Cornelius, Victoria
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Turner, Elizabeth L.
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Hooper, Richard
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Giraudeau, Bruno
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Seed, Paul T.
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Nickless, Alecia
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Grayling, Michael
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Prague, Melanie
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Kerry, Sally
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Bell, Lauren
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Watson, Eila
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Gafoor, Rafael
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Marlin, Nadine
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Yorganci, Emel
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Smith, Lesley
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Mbekwe, Murielle
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Teerenstra, Steven
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Chan, Claire
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Moerbeek, Mirjam
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Jacobsen, Pamela
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Bond, Simon
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Jones, Ben
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Preisser, John
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Kanaan, Mona
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Hewitt, Catherine
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Easter, Christina
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Pellatt-Higgins, Tracy
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Pankhurst, Laura
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Agbla, Schadrac C.
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Eldridge, Sandra
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Lerner, Robin G.
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Leyrat, Clémence
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Pilling, Mark
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Forman, Julia R.
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Bhattacharya, Indrani
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Magill, Nicholas
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Candlish, Jane
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McDowell, Cliona
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Martin, James
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Kristunas, Caroline
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Hemming, Karla, Carroll, Kelly, Thompson, Jennifer, Forbes, Andrew, Taljaard, Monica, Dutton, Susan J., Madurasinghe, Vichithranie, Morgan, Katy, Stuart, Beth, Fielding, Katherine, Cornelius, Victoria, Turner, Elizabeth L., Hooper, Richard, Giraudeau, Bruno, Seed, Paul T., Nickless, Alecia, Grayling, Michael, Prague, Melanie, Kerry, Sally, Bell, Lauren, Watson, Eila, Gafoor, Rafael, Marlin, Nadine, Yorganci, Emel, Smith, Lesley, Mbekwe, Murielle, Teerenstra, Steven, Chan, Claire, Moerbeek, Mirjam, Jacobsen, Pamela, Bond, Simon, Jones, Ben, Preisser, John, Kanaan, Mona, Hewitt, Catherine, Easter, Christina, Pellatt-Higgins, Tracy, Pankhurst, Laura, Agbla, Schadrac C., Eldridge, Sandra, Lerner, Robin G., Leyrat, Clémence, Pilling, Mark, Forman, Julia R., Bhattacharya, Indrani, Magill, Nicholas, Candlish, Jane, McDowell, Cliona, Martin, James and Kristunas, Caroline , The SW-CRT Review Group (2019) Quality of stepped-wedge trial reporting can be reliably assessed using an updated CONSORT: crowd-sourcing systematic review. Journal of Clinical Epidemiology, 107, 77-88. (doi:10.1016/j.jclinepi.2018.11.017).

Record type: Review

Abstract

Objectives: The Consolidated Standards of Reporting Trials extension for the stepped-wedge cluster randomized trial (SW-CRT) is a recently published reporting guideline for SW-CRTs. We assess the quality of reporting of a recent sample of SW-CRTs. Study Design and Setting: Quality of reporting was asssessed according to the 26 items in the new guideline using a novel crowd sourcing methodology conducted independently and in duplicate, with random assignment, by 50 reviewers. We assessed reliability of the quality assessments, proposing this as a novel way to assess robustness of items in reporting guidelines. Results: Several items were well reported. Some items were very poorly reported, including several items that have unique requirements for the SW-CRT, such as the rationale for use of the design, description of the design, identification and recruitment of participants within clusters, and concealment of cluster allocation (not reported in more than 50% of the reports). Agreement across items was moderate (median percentage agreement was 76% [IQR 64 to 86]). Agreement was low for several items including the description of the trial design and why trial ended or stopped for example. Conclusions: When reporting SW-CRTs, authors should pay particular attention to ensure clear reporting on the exact format of the design with justification, as well as how clusters and individuals were identified for inclusion in the study, and whether this was done before or after randomization of the clusters, which are crucial for risk of bias assessments. Some items, including why the trial ended, might either not be relevant to SW-CRTs or might be unclearly described in the statement.

Full text not available from this repository.

More information

Accepted/In Press date: 19 November 2018
e-pub ahead of print date: 28 November 2018
Published date: 1 March 2019
Keywords: CONSORT, Quality of reporting, Reliability, Stepped-wedge cluster randomized trial

Identifiers

Local EPrints ID: 428966
URI: https://eprints.soton.ac.uk/id/eprint/428966
ISSN: 0895-4356
PURE UUID: 5aca313d-73f4-4f2d-89a1-89f812fb4707

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Date deposited: 15 Mar 2019 17:30
Last modified: 15 Mar 2019 17:30

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Contributors

Author: Karla Hemming
Author: Kelly Carroll
Author: Jennifer Thompson
Author: Andrew Forbes
Author: Monica Taljaard
Author: Susan J. Dutton
Author: Vichithranie Madurasinghe
Author: Katy Morgan
Author: Beth Stuart
Author: Katherine Fielding
Author: Victoria Cornelius
Author: Elizabeth L. Turner
Author: Richard Hooper
Author: Bruno Giraudeau
Author: Paul T. Seed
Author: Alecia Nickless
Author: Michael Grayling
Author: Melanie Prague
Author: Sally Kerry
Author: Lauren Bell
Author: Eila Watson
Author: Rafael Gafoor
Author: Nadine Marlin
Author: Emel Yorganci
Author: Lesley Smith
Author: Murielle Mbekwe
Author: Steven Teerenstra
Author: Claire Chan
Author: Mirjam Moerbeek
Author: Pamela Jacobsen
Author: Simon Bond
Author: Ben Jones
Author: John Preisser
Author: Mona Kanaan
Author: Catherine Hewitt
Author: Christina Easter
Author: Tracy Pellatt-Higgins
Author: Laura Pankhurst
Author: Schadrac C. Agbla
Author: Sandra Eldridge
Author: Robin G. Lerner
Author: Clémence Leyrat
Author: Mark Pilling
Author: Julia R. Forman
Author: Indrani Bhattacharya
Author: Nicholas Magill
Author: Jane Candlish
Author: Cliona McDowell
Author: James Martin
Author: Caroline Kristunas

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