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| The CONSORT statement: revised recommendations for improving the quality of reports of parallel-group randomised trials |
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| Author(s): Moher D, Schulz KF, Altman DG |
| Source: LANCET Volume: 357 Issue: 9263 Pages: 1191-1194 Published: APR 14 2001 |
| Times Cited: 1,112 References: 29 |
| Abstract: To comprehend the results of a randomised controlled trial (RCT), readers must understand its design, conduct, analysis, and interpretation. That goal can be achieved only through total transparency from authors. Despite several decades of educational efforts, the reporting of RCTs needs improvement. Investigators and editors developed the original CONSORT (Consolidated Standards of Reporting Trials) statement to help authors improve reporting by use of a checklist and now diagram. The revised CONSORT statement presented here incorporates new evidence and addresses some criticisms of the original statement. The checklist items pertain to the content of the Title, Abstract, Introduction, Methods, Results, and Discussion. The revised checklist includes 22 items selected because empirical evidence indicates that not reporting this information is associated with biased estimates of treatment effect, or because the information is essential to judge the reliability or relevance of the findings. We intended the flow diagram to depict the passage of participants through an RCT. The revised flow diagram depicts information from four stages of a trial (enrolment, intervention allocation, followup, and analysis). The diagram explicitly shows the number of participants, for each intervention group, included in the primary data analysis. Inclusion of these numbers allows the reader to judge whether the authors have done an intention-to-treat analysis. In sum, the CONSORT statement is intended to improve the reporting of an RCT, enabling readers to understand a trial's conduct and to assess the validity of its results. |
| Document Type: Article |
| Language: English |
| Reprint Address: Moher, D (reprint author), Childrens Hosp Eastern Ontario, Thomas C Chalmers Ctr Systemat Reviews, Res Inst, Room R235,401 Smyth Rd, Ottawa, ON K1H 8L1 Canada |
Addresses:
1. Univ Ottawa, Thomas C Chalmers Ctr Systemat Reviews, Ottawa, ON Canada
2. Univ N Carolina, Sch Med, Dept Obstet & Gynecol, Chapel Hill, NC USA
3. Univ N Carolina, Family Hlth Int, Chapel Hill, NC USA
4. Imperial Canc Res Fund, Med Stat Grp, Oxford, England
5. Inst Hlth Sci, Ctr Stat Med, Oxford, England |
| Publisher: LANCET LTD, 84 THEOBALDS RD, LONDON WC1X 8RR, ENGLAND |
| Subject Category: Medicine, General & Internal |
| IDS Number: 423RX |
| ISSN: 0140-6736 |
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