CONSORT statement on the reporting standards of clinical trials

Recommendations are inappropriate for trial reports Editor—In his editorial on the CONSORT statement Douglas G Altman states that since “only randomised trials have the potential directly to affect patient care ... it is ... reasonable to require higher standards for papers reporting randomised trials than those describing other types of study.” 1 But although randomised trials are usually the preferred approach for the unbiased evalua› tion of treatments, non›randomised obser› vational studies also influence treatment. Because the correct interpretation of obser› vational studies is much more difficult, largely due to uncontrollable biases, their description and analysis call for at least as much care as do randomised trials. Some› times, of course, randomised comparisons are unnecessary—for example, to determine the value of AE fetoprotein screening for neural tube defects. CONSORT is the product of delibera› tions conducted almost entirely through North American journals.