Reporting transparency and completeness in Trials: Paper 2 - reporting of randomised trials using registries was often inadequate and hindered the interpretation of results

Kimberly A Mc Cord; Mahrukh Imran; Danielle B Rice; Stephen J McCall; Linda Kwakkenbos; Margaret Sampson; Ole Fröbert; Chris Gale; Sinéad M Langan; David Moher; Clare Relton; Merrick Zwarenstein; Edmund Juszczak; Brett D Thombs; Lars G Hemkens; CONSORT Extension for Trials Conducted Using Cohorts and Routinely Collected Data Group

doi:10.1016/j.jclinepi.2021.09.012

Reporting transparency and completeness in Trials: Paper 2 - reporting of randomised trials using registries was often inadequate and hindered the interpretation of results

Kimberly A Mc Cord, Mahrukh Imran, Danielle B Rice, Stephen J McCall, Linda Kwakkenbos, Margaret Sampson, Ole Fröbert, Chris Gale, Sinéad M Langan, David Moher, Clare Relton, Merrick Zwarenstein, Edmund Juszczak, Brett D Thombs, Lars G Hemkens^* (Corresponding Author), CONSORT Extension for Trials Conducted Using Cohorts and Routinely Collected Data Group

^*Corresponding author for this work

Applied Health Sciences

Research output: Contribution to journal › Article › peer-review

6 Citations (Scopus)

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Abstract

OBJECTIVE: Registries are important data sources for randomized controlled trials (RCTs), but reporting of how they are used may be inadequate. The objective was to describe the current adequacy of reporting of RCTs using registries.

STUDY DESIGN AND SETTING: We used a database of trials using registries from a scoping review supporting the development of the 2021 CONSORT extension for Trials Conducted Using Cohorts and Routinely Collected Data (CONSORT-ROUTINE). Reporting completeness of 13 CONSORT-ROUTINE items was assessed.

RESULTS: We assessed reports of 47 RCTs that used a registry, published between 2011 and 2018. Of the 13 CONSORT-ROUTINE items, 6 were adequately reported in at least half of reports (2 in at least 80%). The 7 other items were related to routinely collected data source eligibility (32% adequate), data linkage (8% adequate), validation and completeness of data used for outcome assessment (8% adequate), validation and completeness of data used for participant recruitment (0% adequate), participant flow (9% adequate), registry funding (6% adequate) and interpretation of results in consideration of registry use (25% adequate).

CONCLUSION: Reporting of trials using registries was often poor, particularly details on data linkage and quality. Better reporting is needed for appropriate interpretation of the results of these trials.

Original language	English
Pages (from-to)	175-186
Number of pages	12
Journal	Journal of Clinical Epidemiology
Volume	141
Early online date	25 Mar 2022
DOIs	https://doi.org/10.1016/j.jclinepi.2021.09.012
Publication status	Published - 2022

Bibliographical note

Funding: The development of CONSORT-ROUTINE and the present review were funded by grants from the Canadian Institutes of Health Research (PI Thombs, #PJT-156172; PIs Thombs and Kwakkenbos, #PCS-161863) and from the United Kingdom National Institute of Health Research (NIHR) Clinical Trials Unit Support Funding. (PI Juszczak, Co-PI Gale, supported salary of SM). The views expressed are those of the author(s) and not necessarily those of the NIHR or the Department of Health and Social Care. Dr. Langan was supported by a Wellcome Senior Clinical Fellowship in Science (205039/Z/16/Z). Dr. Moher is supported by a University Research Chair (uOttawa). Dr. Gale was supported by the United Kingdom Medical Research Council through a Clinician Scientist Fellowship. Dr. Thombs was supported by a Tier 1 Canada Research Chair

Data Availability Statement

Additional data beyond that reported in the main and supplementary materials can be requested from the corresponding author.

Keywords

Registries
CONSORT
CONSORT-ROUTINE
Randomised controlled trials
Reporting guidelines
routinely collected data

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Mc Cord, K. A., Imran, M., Rice, D. B., McCall, S. J., Kwakkenbos, L., Sampson, M., Fröbert, O., Gale, C., Langan, S. M., Moher, D., Relton, C., Zwarenstein, M., Juszczak, E., Thombs, B. D., Hemkens, L. G., & CONSORT Extension for Trials Conducted Using Cohorts and Routinely Collected Data Group (2022). Reporting transparency and completeness in Trials: Paper 2 - reporting of randomised trials using registries was often inadequate and hindered the interpretation of results. Journal of Clinical Epidemiology, 141, 175-186. https://doi.org/10.1016/j.jclinepi.2021.09.012

Reporting transparency and completeness in Trials: Paper 2 - reporting of randomised trials using registries was often inadequate and hindered the interpretation of results. / Mc Cord, Kimberly A; Imran, Mahrukh; Rice, Danielle B et al.
In: Journal of Clinical Epidemiology, Vol. 141, 2022, p. 175-186.

Research output: Contribution to journal › Article › peer-review

Mc Cord, KA, Imran, M, Rice, DB, McCall, SJ, Kwakkenbos, L, Sampson, M, Fröbert, O, Gale, C, Langan, SM, Moher, D, Relton, C, Zwarenstein, M, Juszczak, E, Thombs, BD, Hemkens, LG & CONSORT Extension for Trials Conducted Using Cohorts and Routinely Collected Data Group 2022, 'Reporting transparency and completeness in Trials: Paper 2 - reporting of randomised trials using registries was often inadequate and hindered the interpretation of results', Journal of Clinical Epidemiology, vol. 141, pp. 175-186. https://doi.org/10.1016/j.jclinepi.2021.09.012

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title = "Reporting transparency and completeness in Trials: Paper 2 - reporting of randomised trials using registries was often inadequate and hindered the interpretation of results",

abstract = "OBJECTIVE: Registries are important data sources for randomized controlled trials (RCTs), but reporting of how they are used may be inadequate. The objective was to describe the current adequacy of reporting of RCTs using registries.STUDY DESIGN AND SETTING: We used a database of trials using registries from a scoping review supporting the development of the 2021 CONSORT extension for Trials Conducted Using Cohorts and Routinely Collected Data (CONSORT-ROUTINE). Reporting completeness of 13 CONSORT-ROUTINE items was assessed.RESULTS: We assessed reports of 47 RCTs that used a registry, published between 2011 and 2018. Of the 13 CONSORT-ROUTINE items, 6 were adequately reported in at least half of reports (2 in at least 80%). The 7 other items were related to routinely collected data source eligibility (32% adequate), data linkage (8% adequate), validation and completeness of data used for outcome assessment (8% adequate), validation and completeness of data used for participant recruitment (0% adequate), participant flow (9% adequate), registry funding (6% adequate) and interpretation of results in consideration of registry use (25% adequate).CONCLUSION: Reporting of trials using registries was often poor, particularly details on data linkage and quality. Better reporting is needed for appropriate interpretation of the results of these trials.",

keywords = "Registries, CONSORT, CONSORT-ROUTINE, Randomised controlled trials, Reporting guidelines, routinely collected data",

author = "{Mc Cord}, {Kimberly A} and Mahrukh Imran and Rice, {Danielle B} and McCall, {Stephen J} and Linda Kwakkenbos and Margaret Sampson and Ole Fr{\"o}bert and Chris Gale and Langan, {Sin{\'e}ad M} and David Moher and Clare Relton and Merrick Zwarenstein and Edmund Juszczak and Thombs, {Brett D} and Hemkens, {Lars G} and {CONSORT Extension for Trials Conducted Using Cohorts and Routinely Collected Data Group}",

note = "Funding: The development of CONSORT-ROUTINE and the present review were funded by grants from the Canadian Institutes of Health Research (PI Thombs, #PJT-156172; PIs Thombs and Kwakkenbos, #PCS-161863) and from the United Kingdom National Institute of Health Research (NIHR) Clinical Trials Unit Support Funding. (PI Juszczak, Co-PI Gale, supported salary of SM). The views expressed are those of the author(s) and not necessarily those of the NIHR or the Department of Health and Social Care. Dr. Langan was supported by a Wellcome Senior Clinical Fellowship in Science (205039/Z/16/Z). Dr. Moher is supported by a University Research Chair (uOttawa). Dr. Gale was supported by the United Kingdom Medical Research Council through a Clinician Scientist Fellowship. Dr. Thombs was supported by a Tier 1 Canada Research Chair",

year = "2022",

doi = "10.1016/j.jclinepi.2021.09.012",

language = "English",

volume = "141",

pages = "175--186",

journal = "Journal of Clinical Epidemiology",

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TY - JOUR

T1 - Reporting transparency and completeness in Trials

T2 - Paper 2 - reporting of randomised trials using registries was often inadequate and hindered the interpretation of results

AU - Mc Cord, Kimberly A

AU - Imran, Mahrukh

AU - Rice, Danielle B

AU - McCall, Stephen J

AU - Kwakkenbos, Linda

AU - Sampson, Margaret

AU - Fröbert, Ole

AU - Gale, Chris

AU - Langan, Sinéad M

AU - Moher, David

AU - Relton, Clare

AU - Zwarenstein, Merrick

AU - Juszczak, Edmund

AU - Thombs, Brett D

AU - Hemkens, Lars G

AU - CONSORT Extension for Trials Conducted Using Cohorts and Routinely Collected Data Group

N1 - Funding: The development of CONSORT-ROUTINE and the present review were funded by grants from the Canadian Institutes of Health Research (PI Thombs, #PJT-156172; PIs Thombs and Kwakkenbos, #PCS-161863) and from the United Kingdom National Institute of Health Research (NIHR) Clinical Trials Unit Support Funding. (PI Juszczak, Co-PI Gale, supported salary of SM). The views expressed are those of the author(s) and not necessarily those of the NIHR or the Department of Health and Social Care. Dr. Langan was supported by a Wellcome Senior Clinical Fellowship in Science (205039/Z/16/Z). Dr. Moher is supported by a University Research Chair (uOttawa). Dr. Gale was supported by the United Kingdom Medical Research Council through a Clinician Scientist Fellowship. Dr. Thombs was supported by a Tier 1 Canada Research Chair

PY - 2022

Y1 - 2022

N2 - OBJECTIVE: Registries are important data sources for randomized controlled trials (RCTs), but reporting of how they are used may be inadequate. The objective was to describe the current adequacy of reporting of RCTs using registries.STUDY DESIGN AND SETTING: We used a database of trials using registries from a scoping review supporting the development of the 2021 CONSORT extension for Trials Conducted Using Cohorts and Routinely Collected Data (CONSORT-ROUTINE). Reporting completeness of 13 CONSORT-ROUTINE items was assessed.RESULTS: We assessed reports of 47 RCTs that used a registry, published between 2011 and 2018. Of the 13 CONSORT-ROUTINE items, 6 were adequately reported in at least half of reports (2 in at least 80%). The 7 other items were related to routinely collected data source eligibility (32% adequate), data linkage (8% adequate), validation and completeness of data used for outcome assessment (8% adequate), validation and completeness of data used for participant recruitment (0% adequate), participant flow (9% adequate), registry funding (6% adequate) and interpretation of results in consideration of registry use (25% adequate).CONCLUSION: Reporting of trials using registries was often poor, particularly details on data linkage and quality. Better reporting is needed for appropriate interpretation of the results of these trials.

AB - OBJECTIVE: Registries are important data sources for randomized controlled trials (RCTs), but reporting of how they are used may be inadequate. The objective was to describe the current adequacy of reporting of RCTs using registries.STUDY DESIGN AND SETTING: We used a database of trials using registries from a scoping review supporting the development of the 2021 CONSORT extension for Trials Conducted Using Cohorts and Routinely Collected Data (CONSORT-ROUTINE). Reporting completeness of 13 CONSORT-ROUTINE items was assessed.RESULTS: We assessed reports of 47 RCTs that used a registry, published between 2011 and 2018. Of the 13 CONSORT-ROUTINE items, 6 were adequately reported in at least half of reports (2 in at least 80%). The 7 other items were related to routinely collected data source eligibility (32% adequate), data linkage (8% adequate), validation and completeness of data used for outcome assessment (8% adequate), validation and completeness of data used for participant recruitment (0% adequate), participant flow (9% adequate), registry funding (6% adequate) and interpretation of results in consideration of registry use (25% adequate).CONCLUSION: Reporting of trials using registries was often poor, particularly details on data linkage and quality. Better reporting is needed for appropriate interpretation of the results of these trials.

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KW - CONSORT

KW - CONSORT-ROUTINE

KW - Randomised controlled trials

KW - Reporting guidelines

KW - routinely collected data

U2 - 10.1016/j.jclinepi.2021.09.012

DO - 10.1016/j.jclinepi.2021.09.012

M3 - Article

C2 - 34525408

SN - 0895-4356

VL - 141

SP - 175

EP - 186

JO - Journal of Clinical Epidemiology

JF - Journal of Clinical Epidemiology

ER -

Reporting transparency and completeness in Trials: Paper 2 - reporting of randomised trials using registries was often inadequate and hindered the interpretation of results

Abstract

Bibliographical note

Data Availability Statement

Keywords

Access to Document

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Cite this