Data interpretation
Global QoL results were evaluated based on the comparison between the experimental arm and the control arm, as previously reported [We analyzed abstracts and full texts to assess how authors described and interpreted QoL results. The description was considered “favorable” when (i) authors claimed that global QoL “did not worsen” upon treatment, because a novel therapy should aim to guarantee an improvement in QoL, and not only a reduced worsening; (ii) authors emphasized the effect of treatment on QoL outcomes with superior scores only in some symptoms or functions but without a concomitant improvement in GSH/global QoL; and (iii) authors declared an improvement in QoL results in the same arm, comparing pre- and post-treatment outcomes, without an appropriate comparison between the two arms. The description of QoL data was considered “neutral” when the description and discussion of QoL results were coherent with the data reported in the manuscript or at international conferences. Two investigators independently assessed the description of QoL results in RCTs. Discrepancies were resolved by consensus.