From the Stroke Group, Department of Medicine, King's College
School of Medicine and Dentistry, London, UK.
Correspondence to Dr F. Bath, Division of Stroke Medicine, City Hospital, Nottingham NG5 1PB, UK. E-mail fiona.bath{at}nottingham.ac.uk
Background and Purpose—Several
studies have shown that the quality of reporting of trials throughout
medicine is variable and often poor. We report on the quality of
the final reports of randomized controlled trials (RCTs) of drug
therapies assessed in acute stroke.
Methods—English-language reports published up to the end of 1996
relating to completed RCTs in acute stroke were identified from
electronic searches of the Cochrane Stroke Review Group database of
stroke trials and the Cochrane Controlled Trials Register (CD-ROM issue
1, 1997, of the Cochrane Library). Report quality was assessed with the
33 criteria of the CONSORT statement and 53 additional factors relevant
to acute stroke or trials in general. Trial quality was also assessed
with a 7-point scale.
Results—Up to 1996, 114 RCTs were published which involved
20 536 patients (median, 80; range, 16 to 1267 per trial); 39 (35.5%)
of these were published in Stroke. The median total
report quality was 40/86 (range, 15 to 61) for all criteria and 19/33
(range, 9 to 29) for the CONSORT criteria alone. Although adequate
information was given in the introduction and discussion sections of
most reports, insufficient details were given on methods, assignment of
patients to treatment groups, statistical analyses, the
prevalence of risk factors, and assessment of outcomes. Report quality
has improved between 1956 and 1996 (Spearman correlation coefficient
[rs], 0.575; 95% confidence interval
[CI], 0.439 to 0.685) and was superior in large trials
(rs=0.434; 95% CI, 0.274 to 0.571).
Although report quality was related to trial quality
(rs=0.675; 95% CI, 0.563 to 0.763), it was
not related to journal impact factor
(rs=0.170; 95% CI, -0.015 to 0.344).
Trials with a positive outcome tended to be less well reported than
those with a neutral or negative outcome
(rs=-0.192; 95% CI, -0.351 to
-0.011).
Conclusions—The overall quality of study reports for parallel
group RCTs in acute stroke is poor but appears to be improving with
time and in parallel with an increase in trial size. Reports often lack
detailed information on the methods of randomization, concealment of
allocation, and statistical analysis, all factors which can, if
undertaken poorly, affect trial results and validity. It is vital that
future trials are adequately reported; we believe that authors should
follow the CONSORT guidelines and that referees and editors should
ensure this happens.
© 1998 American Heart Association, Inc.
Comments, Opinions, and Reviews
Quality of Full and Final Publications Reporting Acute Stroke Trials
A Systematic Review
Key Words: stroke, acute • quality control • stroke management • randomized controlled trials
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