Determining the reporting quality of RCTs in clinical pharmacology

Edward Mills, Yoon K. Loke, Ping Wu, Victor Manuel Montori, Daniel Perri, David Moher, Gordon Guyatt

Research output: Contribution to journalArticle

44 Citations (Scopus)

Abstract

Background: The Consolidated Standards for Reporting Trials (CONSORT) are recommendations for improving the quality of reports of randomized controlled trials (RCTs). Objective: To determine the extent to which clinical pharmacology journals implement specific CONSORT recommendations. Design and setting: Analysis of RCTs published between May 2002 and May 2003 in four clinical pharmacology journals. Main outcome measures: Proportion of RCTs that published a participant flow diagram and that reported on randomization and restriction methods, allocation concealment, blinding, intention-to-treat analysis, ethical considerations, adverse events and source of funding. Results: Of 482 clinical trials, 193 were RCTs. Healthy participants were involved in 129 [66.8%, 95% confidence interval (CI) 59.9, 73.1] trials, patients who required treatment in 61 (31.6%, 95% CI 25.4, 38.4) trials and both in three (1.6%, 95% CI 0.5, 4.4) trials. The following items were infrequently reported: sequence generation (17%), allocation concealment (3%), use of restriction (16%), description of blinding (26%), and flow diagrams of study participants (2%). In contrast, the following areas were often reported: use of intention-to-treat analysis (79%), description of withdrawals (92.2%) and description of adverse events (71%), ethics review (94%) and informed consent (95%). Sources of funding were reported in 56% of studies. Conclusion: The use of the selected CONSORT items is limited in these journals, possibly as many items may not be relevant to the types of studies published in clinical pharmacology journals. Further efforts are required to determine the applicability of CONSORT to RCTs in clinical pharmacology.

Original languageEnglish (US)
Pages (from-to)61-65
Number of pages5
JournalBritish Journal of Clinical Pharmacology
Volume58
Issue number1
DOIs
StatePublished - Jul 2004

Fingerprint

Clinical Pharmacology
Randomized Controlled Trials
Intention to Treat Analysis
Confidence Intervals
Random Allocation
Informed Consent
Ethics
Healthy Volunteers
Outcome Assessment (Health Care)
Clinical Trials

Keywords

  • Clinical pharmacology
  • Methodology
  • Randomized controlled trials
  • Reporting quality

ASJC Scopus subject areas

  • Pharmacology (medical)
  • Pharmacology, Toxicology and Pharmaceutics(all)

Cite this

Determining the reporting quality of RCTs in clinical pharmacology. / Mills, Edward; Loke, Yoon K.; Wu, Ping; Montori, Victor Manuel; Perri, Daniel; Moher, David; Guyatt, Gordon.

In: British Journal of Clinical Pharmacology, Vol. 58, No. 1, 07.2004, p. 61-65.

Research output: Contribution to journalArticle

Mills, Edward ; Loke, Yoon K. ; Wu, Ping ; Montori, Victor Manuel ; Perri, Daniel ; Moher, David ; Guyatt, Gordon. / Determining the reporting quality of RCTs in clinical pharmacology. In: British Journal of Clinical Pharmacology. 2004 ; Vol. 58, No. 1. pp. 61-65.
@article{c217fd9f67d24432921244364183c4dc,
title = "Determining the reporting quality of RCTs in clinical pharmacology",
abstract = "Background: The Consolidated Standards for Reporting Trials (CONSORT) are recommendations for improving the quality of reports of randomized controlled trials (RCTs). Objective: To determine the extent to which clinical pharmacology journals implement specific CONSORT recommendations. Design and setting: Analysis of RCTs published between May 2002 and May 2003 in four clinical pharmacology journals. Main outcome measures: Proportion of RCTs that published a participant flow diagram and that reported on randomization and restriction methods, allocation concealment, blinding, intention-to-treat analysis, ethical considerations, adverse events and source of funding. Results: Of 482 clinical trials, 193 were RCTs. Healthy participants were involved in 129 [66.8{\%}, 95{\%} confidence interval (CI) 59.9, 73.1] trials, patients who required treatment in 61 (31.6{\%}, 95{\%} CI 25.4, 38.4) trials and both in three (1.6{\%}, 95{\%} CI 0.5, 4.4) trials. The following items were infrequently reported: sequence generation (17{\%}), allocation concealment (3{\%}), use of restriction (16{\%}), description of blinding (26{\%}), and flow diagrams of study participants (2{\%}). In contrast, the following areas were often reported: use of intention-to-treat analysis (79{\%}), description of withdrawals (92.2{\%}) and description of adverse events (71{\%}), ethics review (94{\%}) and informed consent (95{\%}). Sources of funding were reported in 56{\%} of studies. Conclusion: The use of the selected CONSORT items is limited in these journals, possibly as many items may not be relevant to the types of studies published in clinical pharmacology journals. Further efforts are required to determine the applicability of CONSORT to RCTs in clinical pharmacology.",
keywords = "Clinical pharmacology, Methodology, Randomized controlled trials, Reporting quality",
author = "Edward Mills and Loke, {Yoon K.} and Ping Wu and Montori, {Victor Manuel} and Daniel Perri and David Moher and Gordon Guyatt",
year = "2004",
month = "7",
doi = "10.1111/j.1365-2125.2004.2092.x",
language = "English (US)",
volume = "58",
pages = "61--65",
journal = "British Journal of Clinical Pharmacology",
issn = "0306-5251",
publisher = "Wiley-Blackwell",
number = "1",

}

TY - JOUR

T1 - Determining the reporting quality of RCTs in clinical pharmacology

AU - Mills, Edward

AU - Loke, Yoon K.

AU - Wu, Ping

AU - Montori, Victor Manuel

AU - Perri, Daniel

AU - Moher, David

AU - Guyatt, Gordon

PY - 2004/7

Y1 - 2004/7

N2 - Background: The Consolidated Standards for Reporting Trials (CONSORT) are recommendations for improving the quality of reports of randomized controlled trials (RCTs). Objective: To determine the extent to which clinical pharmacology journals implement specific CONSORT recommendations. Design and setting: Analysis of RCTs published between May 2002 and May 2003 in four clinical pharmacology journals. Main outcome measures: Proportion of RCTs that published a participant flow diagram and that reported on randomization and restriction methods, allocation concealment, blinding, intention-to-treat analysis, ethical considerations, adverse events and source of funding. Results: Of 482 clinical trials, 193 were RCTs. Healthy participants were involved in 129 [66.8%, 95% confidence interval (CI) 59.9, 73.1] trials, patients who required treatment in 61 (31.6%, 95% CI 25.4, 38.4) trials and both in three (1.6%, 95% CI 0.5, 4.4) trials. The following items were infrequently reported: sequence generation (17%), allocation concealment (3%), use of restriction (16%), description of blinding (26%), and flow diagrams of study participants (2%). In contrast, the following areas were often reported: use of intention-to-treat analysis (79%), description of withdrawals (92.2%) and description of adverse events (71%), ethics review (94%) and informed consent (95%). Sources of funding were reported in 56% of studies. Conclusion: The use of the selected CONSORT items is limited in these journals, possibly as many items may not be relevant to the types of studies published in clinical pharmacology journals. Further efforts are required to determine the applicability of CONSORT to RCTs in clinical pharmacology.

AB - Background: The Consolidated Standards for Reporting Trials (CONSORT) are recommendations for improving the quality of reports of randomized controlled trials (RCTs). Objective: To determine the extent to which clinical pharmacology journals implement specific CONSORT recommendations. Design and setting: Analysis of RCTs published between May 2002 and May 2003 in four clinical pharmacology journals. Main outcome measures: Proportion of RCTs that published a participant flow diagram and that reported on randomization and restriction methods, allocation concealment, blinding, intention-to-treat analysis, ethical considerations, adverse events and source of funding. Results: Of 482 clinical trials, 193 were RCTs. Healthy participants were involved in 129 [66.8%, 95% confidence interval (CI) 59.9, 73.1] trials, patients who required treatment in 61 (31.6%, 95% CI 25.4, 38.4) trials and both in three (1.6%, 95% CI 0.5, 4.4) trials. The following items were infrequently reported: sequence generation (17%), allocation concealment (3%), use of restriction (16%), description of blinding (26%), and flow diagrams of study participants (2%). In contrast, the following areas were often reported: use of intention-to-treat analysis (79%), description of withdrawals (92.2%) and description of adverse events (71%), ethics review (94%) and informed consent (95%). Sources of funding were reported in 56% of studies. Conclusion: The use of the selected CONSORT items is limited in these journals, possibly as many items may not be relevant to the types of studies published in clinical pharmacology journals. Further efforts are required to determine the applicability of CONSORT to RCTs in clinical pharmacology.

KW - Clinical pharmacology

KW - Methodology

KW - Randomized controlled trials

KW - Reporting quality

UR - http://www.scopus.com/inward/record.url?scp=3142559736&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=3142559736&partnerID=8YFLogxK

U2 - 10.1111/j.1365-2125.2004.2092.x

DO - 10.1111/j.1365-2125.2004.2092.x

M3 - Article

C2 - 15206994

AN - SCOPUS:3142559736

VL - 58

SP - 61

EP - 65

JO - British Journal of Clinical Pharmacology

JF - British Journal of Clinical Pharmacology

SN - 0306-5251

IS - 1

ER -