Table 4 Characteristics of included publications, by reporting of demographic characteristics
From: Diversity in randomized clinical trials for peripheral artery disease: a systematic review
Study Characteristics | Reporting characteristics: Age | Reporting characteristics: Sex | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Trial Name and Clinical Trial ID No. | Author | Country of PI's affiliation | Study location(s) | Number of study locations | Sex of lead author | Year of publication | Number of enrolled participants | Number of excluded participants | Reporting of age | Age (mean) | Age (SD) | Reporting of sex | Male (n) | Female (n) |
EMINENT NCT02921230 | Gouëffic et al., 2022 [31] | Germany and France | Austria, Belgium,France, Germany, Ireland,Italy, Netherlands, Spain, Switzerland,UK | 60 | Male | 2022 | 775 | 73 | Yes | 68.9 | 8.9 | Yes | 543 | 232 |
AcoArt II/BTK China NCT02137577 | Jia et al., 2021 [32] | China | China (Dalian, Beijing Shanghai, Guangzhou, Shenyang, Shijiazhuang, and Tianjin) | 11 | Unknown | 2021 | 120 | 5 | Yes | 70.75 | 8.2 | Yes | 72 | 48 |
BIOLUX P-II NCT01867736 | Zeller et al., 2015 [33] | Germany | Austria, Belgium [ Bonheiden and Dendermonde], and Germany [ Bad Krozingen, Berlin, and Leipzig]) | 6 | Male | 2015 | 72 | 16 | Yes | 71.25 | 9.6 | Yes | 57 | 15 |
SINGA-PACLI NCT02129634 | Patel et al., 2021 [34] | Singapore | Singapore | 2 | Male | 2021 | 138 | 48 | Yes | 62.5 | 10 | Yes | 93 | 45 |
The Chocolate Touch Study NCT02924857 | Shishehbor et al., 2022 [35] | USA and Germany | US, Austria, Germany, New Zealand | 27 | Male | 2022 | 333 | 20 | Yes | 69.4 | 9.5 | Yes | 180 | 133 |
ILLUMENATE NCT01858428 | Krishnan et al., 2017 [36] | USA | United States and Austria | 44 | Male | 2017 | 300 | 30 | Yes | 69.05 | 10.05 | Yes | 176 | 124 |
TIGRIS NCT01576055 | Laird et al., 2018 [37] | USA | USA | 36 | Male | 2018 | 267 | 25 | Yes | 67.3 | 9.1 | Yes | 190 | 77 |
ILLUMENATE EU NCT01858363 | Schroeder et al., 2017 [38] | Germany | Germany | 18 | Male | 2017 | 294 | 54 | Yes | 68 | 9 | Yes | 209 | 85 |
COMPARE NCT02701543 | Steiner et al., 2020 [39] | Germany | Germany | 1 | Female | 2020 | 414 | 22 | Yes | 68.3 | 9.65 | Yes | 260 | 154 |
ZILVERPASS NCT01952457 | Bosiers et al., 2020 [40] | Belgium | Belgium | 5 | Male | 2020 | 220 | 15 | Yes | 68.6 | 10.45 | Yes | 159 | 61 |
RANGER II SFA NCT03064126 | Sachar et al., 2021 [41] | USA and Germany | USA and Germany | 67 | Male | 2021 | 376 | 33 | Yes | 69.85 | 9.9 | Yes | 240 | 136 |
NR ChiCTR1900023619 | Liao et al., 2022 [42] | China | China | 1 | Male | 2022 | 60 | 2 | Yes | 68.75 | 8.8 | Yes | 38 | 22 |
IMPERIAL NCT02574481 | Gray et al., 2018 [43] | USA and Germany | USA and Germany | 68 | Male | 2018 | 465 | 25 | Yes | 68.15 | 9.45 | Yes | 308 | 157 |
REAL PTX NCT01728441 | Bausback et al., 2019 [44] | Germany | Germany | 5 | Female | 2019 | 150 | 28 | Yes | 68.85 | 9.55 | Yes | 102 | 48 |
Study Characteristics | Reporting characteristics: Race | Reporting of other demographic characteristics (socio-economic status, marital status, immigration, etc.) | Clinical outcomes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Trial Name and Clinical Trial ID No. | Author | Reporting of race | White (n) | Black (n) | American Indian/Alaska Native (n) | Hispanic/Latino (n) | Asian (n) | Native Hawaian/Pacific Islander (n) | Other (n) | Not disclosed (n) | Reporting of outcomes by demographics | Clinical outcome reported by demographic characteristics | |
EMINENT NCT02921230 | Gouëffic et al., 2022 [31] | Yes | 668 | 3 | 1 | 2 | 1 | 0 | 24 | 76 | No | No | No |
AcoArt II/BTK China NCT02137577 | Jia et al., 2021 [32]Â | No | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | No | No | No |
BIOLUX P-II NCT01867736 | Zeller et al., 2015 [33] | No | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | No | No | No |
SINGA-PACLI NCT02129634 | Patel et al., 2021 [34] | No | 0 | 0 | 0 | 0 | 67 | 0 | 3 | 0 | No | No | No |
The Chocolate Touch Study NCT02924857 | Shishehbor et al., 2022 [35] | No | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | No | No | No |
ILLUMENATE NCT01858428 | Krishnan et al., 2017 [36] | No | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | No | Sex | Primary patency and CD-TLR |
TIGRIS NCT01576055 | Laird et al., 2018 [37] | Yes | 168 | 20 | 0 | 0 | 4 | 0 | 4 | 0 | No | No | No |
ILLUMENATE EU NCT01858363 | Schroeder et al., 2017 [38] | No | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | No | Sex | Primary patency |
COMPARE NCT02701543 | Steiner et al., 2020 [39] | No | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | No | No | No |
ZILVERPASS NCT01952457 | Bosiers et al., 2020 [40] | No | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | No | No | No |
RANGER II SFA NCT03064126 | Sachar et al., 2021 [41] | Yes | 214 | 24 | 1 | 29 | 102 | 0 | 1 | 5 | No | Yes | No |
NR ChiCTR1900023619 | Liao et al., 2022 [42] | No | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | No | No | No |
IMPERIAL NCT02574481 | Gray et al., 2018 [43] | Yes | 313 | 32 | 4 | 24 | 113 | 1 | 4 | 2 | No | No | No |
REAL PTX NCT01728441 | Bausback et al., 2019 [44] | No | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | No | No | No |