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Quality of reporting in randomized trials published in high-quality surgical journals

Quality of reporting in randomized trials published in high-quality surgical journals
Quality of reporting in randomized trials published in high-quality surgical journals
Background: Randomized controlled trials (RCTs) in surgery can provide valuable evidence of the efficacy of interventions if they are well-designed, appropriately executed, and adequately reported. Adequate reporting of methodology in surgical RCTs is known to be poor, and adverse-event reporting in surgical research is inconsistent. The Consolidated Standards of Reporting Trials (CONSORT) statement is a framework to help authors report their findings in a transparent manner. Extensions to the CONSORT statement have been published recently to address deficiencies in adverse-event reporting and in reporting of specific criteria related to nonpharmacologic treatments. The aim of this study was to assess the quality of reporting of trial methodology and adverse events in a sample of general surgical RCTs published in high-quality surgical journals using the criteria specified in the CONSORT statements.

Study Design: We used impact factor to identify the top three ranked surgical journals in 2004. We then obtained information on all RCTs published in these journals in the 2005 calendar year. We assessed quality of reporting using Jadad score, compared the quality of RCTs from CONSORT-endorsing journals with nonendorsers, and assessed the number of RCTs adequately reporting key generic methodologic, adverse-event?related, and specific nonpharmacologic criteria.

Results: Of 42 RCTs analyzed, only 40% (17 of 42) had a Jadad score ?3. There was no significant difference in the number of high-quality RCTs published in CONSORT-endorsing journals compared with nonendorsers (p = 0.3). The median percentage of RCTs adequately reporting generic methodologic, adverse-event?related, and specific nonpharmacologic criteria was 32.5%, 17%, and 36.5%, respectively.

Conclusions: Quality of reporting of generic methodologic, adverse-event?related, and specific nonpharmacologic criteria in surgical RCTs is poor. Increased attention to quality of reporting of surgical RCTs is required if studies are to meet published criteria.
565-571.e1
Sinha, Sidhartha
5d8ddbfe-4fec-43d5-9370-151ab1280060
Sinha, Shrestha
a82e6296-e955-4f62-836c-be9197fa70c7
Ashby, Elizabeth
63803239-a2eb-4819-b58a-157f75441207
Jayaram, Raja
a6287c07-601b-420e-9d35-3850f1a050d5
Grocott, Michael P.W.
1e87b741-513e-4a22-be13-0f7bb344e8c2
Sinha, Sidhartha
5d8ddbfe-4fec-43d5-9370-151ab1280060
Sinha, Shrestha
a82e6296-e955-4f62-836c-be9197fa70c7
Ashby, Elizabeth
63803239-a2eb-4819-b58a-157f75441207
Jayaram, Raja
a6287c07-601b-420e-9d35-3850f1a050d5
Grocott, Michael P.W.
1e87b741-513e-4a22-be13-0f7bb344e8c2

Sinha, Sidhartha, Sinha, Shrestha, Ashby, Elizabeth, Jayaram, Raja and Grocott, Michael P.W. (2009) Quality of reporting in randomized trials published in high-quality surgical journals. Journal of the American College of Surgeons, 209 (5), 565-571.e1. (doi:10.1016/j.jamcollsurg.2009.07.019).

Record type: Article

Abstract

Background: Randomized controlled trials (RCTs) in surgery can provide valuable evidence of the efficacy of interventions if they are well-designed, appropriately executed, and adequately reported. Adequate reporting of methodology in surgical RCTs is known to be poor, and adverse-event reporting in surgical research is inconsistent. The Consolidated Standards of Reporting Trials (CONSORT) statement is a framework to help authors report their findings in a transparent manner. Extensions to the CONSORT statement have been published recently to address deficiencies in adverse-event reporting and in reporting of specific criteria related to nonpharmacologic treatments. The aim of this study was to assess the quality of reporting of trial methodology and adverse events in a sample of general surgical RCTs published in high-quality surgical journals using the criteria specified in the CONSORT statements.

Study Design: We used impact factor to identify the top three ranked surgical journals in 2004. We then obtained information on all RCTs published in these journals in the 2005 calendar year. We assessed quality of reporting using Jadad score, compared the quality of RCTs from CONSORT-endorsing journals with nonendorsers, and assessed the number of RCTs adequately reporting key generic methodologic, adverse-event?related, and specific nonpharmacologic criteria.

Results: Of 42 RCTs analyzed, only 40% (17 of 42) had a Jadad score ?3. There was no significant difference in the number of high-quality RCTs published in CONSORT-endorsing journals compared with nonendorsers (p = 0.3). The median percentage of RCTs adequately reporting generic methodologic, adverse-event?related, and specific nonpharmacologic criteria was 32.5%, 17%, and 36.5%, respectively.

Conclusions: Quality of reporting of generic methodologic, adverse-event?related, and specific nonpharmacologic criteria in surgical RCTs is poor. Increased attention to quality of reporting of surgical RCTs is required if studies are to meet published criteria.

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More information

Published date: November 2009

Identifiers

Local EPrints ID: 73616
URI: http://eprints.soton.ac.uk/id/eprint/73616
PURE UUID: 3548efac-869d-4c2c-bf9b-2f521c708c33
ORCID for Michael P.W. Grocott: ORCID iD orcid.org/0000-0002-9484-7581

Catalogue record

Date deposited: 10 Mar 2010
Last modified: 14 Mar 2024 02:54

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Contributors

Author: Sidhartha Sinha
Author: Shrestha Sinha
Author: Elizabeth Ashby
Author: Raja Jayaram

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