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. 2020 Jan 8;125(3):355–368. doi: 10.1111/bju.14967

Table 1.

Study criteria.

Study Inclusion period Country Inclusion criteria for AS Patients, n Age, years, median (range) Follow‐up, months, median (range) Overall metastatic rate, % Central pathology review Overall risk of bias
AS studies
Gilbert et al. 2016 [15] NR UK NR 177 NR NR NR Yes High
Li et al. 2015 [16] 1999–2013 China NR 78 29.5 (14–56) 74.4 (12–180) 23.1 Yes High
Kollmannsberger et al. 2015 [1] 1983–2012 Canada, Norway, Sweden, UK, USA NR 1139 30 (14–85) 62 (1–277) 19.4 No High
Daugaard et al. 2014 [17] 1984–2007 Denmark Standard policy 1226 30 (15–79) 180 (1–346) 31.2 No Moderate
Keskin et al. 2011 [18] 2002–2009 Turkey Patient preference 70 27.8 (16–67) 18.5 (6–71) 17.1 Yes High
Sturgeon et al. 2011 [19] 1981–2005 Canada Preferred management option, no pure choriocarcinoma 371 Mean 30.5 (13.2–76.6) 75.6 (0.96–310.8) 28.0 Yes Moderate
Kollmannsberger et al. 2010 [20] 1998–2007 Canada Preferred management option 223 29 (15–63) 52 (3–136) 26.5 Yes Moderate
Atsü et al. 2003 [21] 1978–2000 Turkey Normalization of markers 132 28 (16–52) 38 (6–265) 24.2 Yes High
Daugaard et al. 2003 [22] 1984–2002 Denmark Standard policy 301 34 (15–72) 60 (1–226) 28.6 No High
Alexandre et al. 2001 [23] 1984–1996 France Patient preference, not based on histopathological characteristics 88 30.5 (15.9–55.7) 51.6 (12–144) 27.3 Yes Moderate
Roeleveld et al. 2001 [24] 1982–1994 The Netherlands No pure choriocarcinoma, no history of any previous tumour 90 Mean 30 (16–60) 97.2 25.6 Yes Moderate
Colls et al. 1999 [25] 1980–1997 New Zealand Histological NSGCT, seminoma with β‐HCG ≥300 IU/L, or seminoma with elevated AFP 248 29 (16–77) 53 (1–185) 28.2 No High
Sogani et al. 1998 [26] 1979–1987 USA No T2–T4, no pure choriocarcinoma, no pure seminoma, no history of orchidopexy, no unreliability for close follow‐up 105 26 (15–46) 135.6 (28.8–201.6) 25.7 Yes High
Maher and Lee 1998 [27] 1980–1993 UK Standard policy 42 28 (18–53) 79.4 (30.6–183.2) 31.0 Yes High
Gels et al. 1995 [28] 1982–1992 The Netherlands Standard policy 154 29 (15–66) 84 (24–144) 27.3 No Moderate
Nicolai and Pizzocaro 1995 [29] 1981–1984 Italy Offered to all CS I patients, no tumour at cut end of spermatic cord 85 NR 132 (114–156) 29.4 Yes High
Ondrus and Hornak 1994 [30] 1984–NR Slovakia No seminoma or choriocarcinoma component 80 27 (13–58) Mean: 83.1 (61–110) 36.3 NR High
Tekgül et al. 1995 [31] 1985–1994 Turkey No tumour at cut end of spermatic cord, eligible for close and proper AS 58 31 (17–43) 39 (14–79) 29.3 Yes High
Read et al. 1992 [32] 1984–1987 UK and Norway No tumour at cut end of spermatic cord 373 NR 60 26.8 Yes Moderate
Sturgeon et al. 1992 [33] 1981–NR Canada Preferred management option, no pure choriocarcinoma 105 28 (17–76) 60 (12–121) 35.2 Yes Moderate
Rørth et al. 1991 [34] 1980–1984 Denmark Randomisation 83 30 (17–64) 64 (33–103) 27.7 Yes High
Wishnow et al. 1989 [46] 1981–1987 USA NR 82 NR NR 29.3 Yes High
Dunphy et al. 1988 [35] 1981–1986 USA NR 93 Mean 28 (16–54) 34 (12–61) 30.1 Yes Moderate
Thompson et al. 1988 [36] 1979–NR New Zealand No tumour at cut end of spermatic cord 36 27 (18–45) 36 (14–92) 33.3 Yes High
Freedman et al. 1987 [37] 1979–1983 UK NR 259 NR 30 (10–63) 27.0 Yes Moderate
Hoskin et al 1986 [38] 1979–1985 UK Histological NSGCT or seminoma with elevated AFP, no tumour at cut end of spermatic cord 126 NR 42 28.6 Yes Moderate
Primary RPLND studies
Nicolai et al. 2011* [39] 2002–2007 Italy NR 183 NR NR 18.6 Yes Moderate
Albers et al. 2003[10] 1996–2002 Germany CS I, randomisation 165 Mean 31.3 (SD 8.3) Mean 34.5 (12–64) 37.6 Yes Moderate
Spermon et al. (2002)* [40] 1986–1992 The Netherlands NR 50 NR NR 30.0 Yes High
Sweeney et al. 2000[43] 1990–1995 USA NR 292 NR 46 (24–89) 30.5 Yes Moderate
Albers et al. 1997[47] 1983–1994 Germany NR 78 NR Mean 58.2 (8–149) 35.9 Yes High
Albers et al. (1995)* [45] 1992–1993 USA CS I 90 NR Mean 15.9 (5–27) 27.8 Yes High
Moul et al. 1994* [44] 1980–1993 USA NR 92 NR NR (1–10) 41.3 Yes High
Klepp et al. 1990[42] 1981–1986 Sweden, Norway CS I, no previous malignancy 279 NR 50 (30–90) 37.6 Yes Moderate
Fung et al. 1988* [41] 1979–1987 USA NR 60 25 (15–56) 18 (NR) 33.3§ Yes Moderate
Total 1978–2013     7113          

AFP, α‐fetoprotein; β‐HCG, β‐human chorionic gonadotropin; NR, not reported. *Study endpoint is pathological Stage II. Study endpoint is pathological Stage II or relapse after pathological Stage I. Includes patients reported in multiple studies. §48.3% including patients with relapse after pathological Stage I.