Reporting methodology protocols in three acute care journals

Abstract

Our study compared the reporting of methodology protocol details in three acute care journals, Annals of Emergency Medicine, Critical Care Medicine, and Journal of Trauma. Eleven criteria previously reported for evaluation of clinical trials in the medical literature were used. These were eligibility criteria, admission before allocation, random allocation, method of randomization, patients' blindness to treatment, blind assessment of outcome, treatment complications, loss to follow-up, statistical methods, statistical analysis, and power. All prospective, interventional, controlled trials appearing in the journals from January 1980 to June 1983 were identified. A total of 45 trials was found. Each study was read independently by two reviewers to determine whether each of the 11 criteria was reported clearly, reported unclearly, or not applicable. Disagreements were resolved by a third reader (adjudicator). The results are reported as the mean proportion of items clearly reported plus or minus the standard deviation: Annals of Emergency Medicine (n = 16), 0.40 +/- 0.18; Journal of Trauma (n = 18), 0.41 +/- 0.24; Critical Care Medicine (n = 11), 0.35 +/- 0.18. A one-way analysis of variance found no statistically significant difference between journals with respect to these proportions (P = .75). The study reveals that these journals, as judged by these criteria, do not report enough methodologic information to allow assessment of bias-reducing techniques and statistical methodology.