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Most anesthesia providers made no (0) errors for most trials (N = 96/120 trials, lower 95% limit 73%, P < 0.0001).
However, a review of 58 RCTs using the Zelen design found that while most trials (n = 41) experienced some crossover from one group to the other (median crossover = 8.9%, interquartile range 2.6%to15%5%) the rate was usually within acceptable limits [ 26].
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Most of the trials (n = 47, 59.5%) were publicly funded, with the remaining trials being funded by either a charity (n = 19, 24.1%) or industry (n = 13, 16.5%).
Of the submitted trials, 104 (46.0%) were sponsored by the pharmaceutical industry and 122 (54.0%) were non-industry trials, of which 31 were financially or materially supported by a for-profit organisation (13.7% of the total number of trials).> Most studies were multicentre trials (n = 126; 55.8%) and were mostly conducted in The Netherlands only (n = 131; 58.0%) (Table 2).
A majority were randomized controlled trials (n = 13) and most addressed postoperative pain (n = 15).
However, most trials incorporate unvalidated definitions of cognitive impairment (n = 13) that vary across studies.
Whilst more recent trials were more likely to provide a justification of sample size, sample sizes were generally small (see Additional file 1) with most trials including fewer than forty subjects (range n = 20 58).
Most trials recruited adult subjects capable of giving informed consent (n = 208; 92.0%), while 7 (3.1%) trials included adult subjects not capable of giving informed consent and/or minors <18 years, and 11 (4.9%) included both types of subjects.
Most trials received comments on the subject information sheet and consent form (n = 182, 80.5%), methodology and planned statistical analyses (n = 160, 70.8%), and supporting documentation, including clinical trial agreements and certificates of insurance (n = 154, 68.1%).
Based on data from four trials (n = 250), sleep latency and sleep duration were most affected.
The exact distribution of T- and N-stages was not available for all but for most trials.
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