Has CONSORT improved the reporting of randomized controlled trials in the palliative care literature? A systematic review

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

CONSORT palliative randomized controlled trials systematic

Get full access to this article

View all access options for this article.

References

Chalmers TC , Celano P , Sacks HS , Smith H . Bias in treatment assignment in controlled clinical trials. N Engl J Med 1983: 1358–1361.

Schulz KF , Chalmers I , Hayes RJ , Altman DG . Empirical evidence of bias. JAMA 1995; 273: 408–412.

Jadad AR , Moore RA , Carroll D , et al. Assessing the quality of reports of randomized clinical trials: is blinding necessary? Controlled Clin Trials 1996; 17: 1–12.

Begg CB , Cho MK , Eastwood S , et al. Improving the quality of reporting of randomized controlled trials: the CONSORT statement. JAMA 1996; 276: 637–639.

Moher M , Schulz KF , Altman DG for the CONSORT group . The CONSORT statement: revised recommendations for improving the quality of reports of parallel group randomized trials. JAMA 2001; 285: 1987–1991.

Dickersin K , Scherer R , Lefebure C . Identification of relevant studies for systematic reviews, BMJ 1994; 309: 1286–1291

Clarke M, Oxman AD editors. Cochrane reviewers handbook 4.1 [updated] December 2000. In The Cochrane Library, Issue 2, 2000 Oxford. Update Software. Updated Quarterly.

Cochrane Library. Issue 2, 1999 Oxford. Update Software. Updated Quarterly.

Adetugbo K , Williams H . How well are randomized controlled trials reported in the dermatology literature? Arch Dermatol 2000; 136: 381–385.

10.

Ah-See KW , Molony NC . A qualitative assessment of randomized controlled trials in otolaryngology. J Laryngol Otol 1998; 112: 460–463.

11.

Bath FJ , Owen VE , Bath PMW . Quality of full and final publications reporting acute stroke trials. Stroke 1998; 29: 2203–2210.

12.

Moher D , Jones A , Lepage L for the CONSORT group . Use of the CONSORT statement and quality of reports of randomized controlled trials. A comparative before-and-after evaluation. JAMA 2001; 285: 1992–1995.