Has CONSORT improved the reporting of randomized controlled trials in the palliative care literature? A systematic review
Open Access
- 1 January 2004
- journal article
- review article
- Published by SAGE Publications in Palliative Medicine
- Vol. 18 (1), 32-38
- https://doi.org/10.1191/0269216304pm857oa
Abstract
Background: In 1996, the CONSORT (CONsolidated Standards Of Reporting Trials) statement for the reporting of clinical trials was produced, based on empirical evidence regarding bias. Aims: This study assessed the quality of reporting of randomized controlled trials (RCTs) in the palliative care literature. Methods: Three specialist journals were hand searched for RCTs. A checklist was devised based on CONSORT recommendations. Two investigators independently assessed all the trials against this checklist. The trials were grouped into time cohorts of five years and quality comparisons made. Trials looking at pain were compared with those trials looking at other aspects of palliative care. Results: Ninety-three RCTs were identified. The number of trials has increased over time: nine in the first cohort, 37 in the second and 47 in the last cohort. The number of patients in the individual trials has also increased over time. Generally, the reporting quality was poor, particularly the areas of allocation concealment, randomization technique and intention to treat analysis, where there is empirical evidence, that it leads to trial bias. Although there were more pain papers than non-pain papers, the quality of reporting was only better for blinding and intention to treat analysis. Conclusion: The quality of reporting of RCTs in the palliative care literature is generally poor. However, there has been an increase in the number and the size of RCTs being carried out. This shows recognition of the importance of an evidence base in palliative care. However, in order to guide clinical decision making, future trials need to improve the quality of their reporting by adhering to the CONSORT statement.Keywords
This publication has 10 references indexed in Scilit:
- Use of the CONSORT Statement and Quality of Reports of Randomized TrialsJAMA, 2001
- The CONSORT Statement: Revised Recommendations for Improving the Quality of Reports of Parallel-Group Randomized TrialsJAMA, 2001
- How Well Are Randomized Controlled Trials Reported in the Dermatology Literature?Archives of Dermatology, 2000
- Quality of Full and Final Publications Reporting Acute Stroke TrialsStroke, 1998
- A qualitative assessment of randomized controlled trials in otolaryngology.The Journal of Laryngology & Otology, 1998
- Improving the Quality of Reporting of Randomized Controlled TrialsJAMA, 1996
- Assessing the quality of reports of randomized clinical trials: Is blinding necessary?Controlled Clinical Trials, 1996
- Empirical Evidence of BiasJAMA, 1995
- Systematic Reviews: Identifying relevant studies for systematic reviewsBMJ, 1994
- Bias in Treatment Assignment in Controlled Clinical TrialsNew England Journal of Medicine, 1983