DI Jiaqi, LI Xuanlin, CAO Jiamin, et al. Analysis of the Outcome Indicators in Randomized Controlled Trials of Idiopathic Pulmonary Fibrosis[J]. Journal of Traditional Chinese Medicine2021, 62(12): 1040-1045.
DI Jiaqi, LI Xuanlin, CAO Jiamin, et al. Analysis of the Outcome Indicators in Randomized Controlled Trials of Idiopathic Pulmonary Fibrosis[J]. Journal of Traditional Chinese Medicine2021, 62(12): 1040-1045.DOI: 10.13288/j.11-2166/r.2021.12.007.
Objective To analyze the outcome indicators used in current randomized controlled trials(RCTs) of idiopathic pulmonary fibrosis(IPF)
and to provide references for the rational use of outcome indicators in IPF clinical researches. Methods Databases including CNKI
Wanfang
VIP
Sinomed
PubMed and Web of Science were searched from the inception date to May 8 th
2020 for RCTs of IPF. Literature was screened and data was extracted. The frequency of outcome indicators in RCTs of IPF were descriptively analyzed. Results Totally 84 RCTs were included involving 71 outcome indicators with the frequency of 672 times. The outcome indicators were grouped into seven types
which include 25 physicochemical outcomes with frequency of 251 times(37.35%)
12 symptom and syndrome outcomes with frequency of 92 times(13.69%)
11 long-term prognostic outcomes with frequency of 115 times(17.11%)
8 quality of life outcomes with frequency of 58 times(8.63%)
3 safety outcomes with frequency of 105 times(15.63%)
2 traditional Chinese medicine symptom/syndrome outcomes with frequency of four times(0.60%)
and 10 other outcomes with frequency of 47 times(6.99%). Conclusion The outcome indicators are varied in current RCTs of IPF; some outcomes have no unified evaluation criteria; and there are problems of irregular use of the outcomes. Therefore