Assessing quality of reports on randomized clinical trials in nursing journals.
BACKGROUND
Several surveys have presented the quality of reports on randomized clinical trials (RCTs) published in general and specialty medical journals. The aim of these surveys was to raise scientific consciousness on methodological aspects pertaining to internal and external validity. These reviews have suggested that the methodological quality could be improved.


OBJECTIVE
We conducted a survey of reports on RCTs published in nursing journals to assess their methodological quality. The features we considered included sample size, flow of participants, assessment of baseline comparability, randomization, blinding, and statistical analysis.


METHODS
We collected data from all reports of RCTs published between January 1994 and December 1997 in Applied Nursing Research, Heart & Lung and Nursing Research. We hand-searched the journals and included all 54 articles in which authors reported that individuals have been randomly allocated to distinct groups. We collected data using a condensed form of the Consolidated Standards of Reporting Trials (CONSORT) statement for structured reporting of RCTs (Begg et al., 1996).


RESULTS
Sample size calculations were included in only 22% of the reports. Only 48% of the reports provided information about the type of randomization, and a mere 22% described blinding strategies. Comparisons of baseline characteristics using hypothesis tests were abusively produced in more than 76% of the reports. Excessive use and unstructured reports of significance testing were common (59%), and all reports failed to provide magnitude of treatment differences with confidence intervals.


CONCLUSIONS
Better methodological quality in reports of RCTs will contribute to increase the standards of nursing research.
Parent
Nicole
N
Montreal Heart Institute, 5000 Bélanger, Montreal, QC, H1T 1C8. nicole.parent@icm-mhi.org
Hanley
James A
JA
D003627:Data Interpretation, Statistical; D019983:Guideline Adherence / Q000706:statistics & numerical data; D017408:Guidelines as Topic; D006801:Humans; D015399:Nursing Research / Q000592:standards* / Q000706:statistics & numerical data; D017712:Peer Review, Research; D010506:Periodicals as Topic; D011643:Publishing; D016032:Randomized Controlled Trials as Topic / Q000592:standards* / Q000706:statistics & numerical data; D012107:Research Design / Q000592:standards* / Q000706:statistics & numerical data; D018401:Sample Size