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. 2010 Mar 13;468(6):1635–1648. doi: 10.1007/s11999-010-1285-9

Table 2.

Quality assessment of randomized controlled trials

Item Chin et al. 2007 [8] Kim et al. 2007 [25] Kolisek et al. 2007 [27] Shen et al. 2007 [39] Tashiro et al. 2007 [40] Chotanaphuti et al. 2008 [9] Han et al. 2008 [15] Lüring et al. 2008 [32] Karachalios et al. 2008 [20] Kashyap & van Ommeren 2008 [22] Wohlrab et al. 2009 [47] Juosponis et al. 2009 [19] Karpman & Smith [21]
1. Was there clear concealment of allocation? 3 1 3 1 1 1 0 3 3 0 1 3 1
2. Were the inclusion and exclusion criteria clearly defined? 1 1 1 1 1 1 1 1 1 0 1 1 1
3. Were the outcomes of trial participants who withdrew or excluded after allocation described and included in an intention-to-treat analysis? 0 0 0 1 0 0 1 1 1 0 0 0 1
4. Were the treatment and control groups adequately described at entry, and if so were the groups well matched or appropriate covariate adjustment made? 1 1 1 1 1 1 1 1 1 1 1 1 1
5.Were the healthcare workers/ surgeons experienced in both interventions prior to the start of the trials? 1 1 0 0 0 1 1 1 0 1 0 1 0
6. Were the care programs other than trial options identical? 1 1 0 1 1 0 1 1 1 1 0 1 1
7.Were the outcome measures clearly defined in the text with a definition of any ambiguous terms encountered? 1 1 1 1 1 1 1 1 1 1 1 1 1
8. Were the outcome assessors blind to assignment status? 1 1 0 0 0 0 1 0 1 0 0 0 1
9. Was the timing of outcome measures appropriate? 1 1 1 1 1 1 1 1 1 1 1 1
10.Was followup active with the trial participants being called back or approached for assessment at set times or passive? 0 1 1 1 1 0 1 1 0 1 0 1 1
11.Was loss to followup reported, and if so were less than 5% of trial participants lost to followup? 0 0 0 1 0 1 1 1 1 1 0 0 1
12.Were the authors able to provide supplementary details of the trial in addition to published data? 1 0 0 1 0 0 0 0 0 0 0 0 0
Total 11 9 8 10 7 7 11 12 11 7 5 10 10