Peritoneal Dialysis Guidelines 2019 Part 2: Main Text (Position paper of the Japanese Society for Dialysis Therapy)

Ryuzaki, Munekazu; Ito, Yasuhiko; Nakamoto, Hidetomo; Ishikawa, Yuichi; Itami, Noritomo; Ito, Minoru; Ueda, Atsushi; Kanazawa, Yoshie; Kawanishi, Hideki; Kanno, Yoshihiko; Sugiyama, Hitoshi; Tsuruya, Kazuhiko; Terawaki, Hiroyuki; Tomo, Tadashi; Fukasawa, Mizuya; Yamashita, Akihiro C.; Yokoi, Hideki; Nakayama, Masaaki; Yuasa, Hidemichi; Tsujimoto, Yasushi; Tsujimoto, Hiraku; Saka, Yosuke; Kuroki, Yusuke; Yasuda, Kaoru; Fujii, Takayuki; Kanno, Atsuhiro; Fujikura, Emi; Watanabe, Kimio; Obata, Yoko; Murashima, Miho; Toda, Naohiro; Yamamoto, Shuto; Tsujimoto, Yoshihiro; Sakurada, Tsutomu; Komukai, Daisuke; Uchiyama, Kiyotaka; Washida, Naoki; Morimoto, Kohkichi; Kasai, Takahiro; Maruyama, Yukio; Higuchi, Chieko; Io, Hiroaki; Wakabayashi, Keiichi

doi:10.1186/s41100-021-00361-9

Table 8 Evidence profile

From: Peritoneal Dialysis Guidelines 2019 Part 2: Main Text (Position paper of the Japanese Society for Dialysis Therapy)

Certainty assessment							Number of patients		Effect		Certainty	Importance
No. of studies	Study design	Bias risk	Inconsistency	Indirectness	Inaccuracy	Other	Laparoscopy	Laparotomy	Relative [95% CI]	Absolute (95% CI)	Certainty	Importance
Catheter survival (larger numbers indicate superiority of laparoscopy) (transplants and deaths included in withdrawals)
6	RCT	Serious ^a	Not serious	Not serious ^b	Serious ^c	None	211/263 (80.2%)	198/263 (75.3%)	RR 1.07 [0.98–1.16]	53 patients increased per 1000 patients (15 patients decreased to 120 patients increased)	⨁⨁◯◯ Low	Critical
Catheter survival (larger numbers indicate superiority of laparoscopy) (transplants and deaths not included in withdrawals)
5	RCT	Serious ^a	Not serious	Not serious ^b	Serious ^c	None	172/211 (81.5%)	164/213 (77.0%)	RR 1.02 [0.92–1.13]	15 patients increased per 1000 patients (62 patients decreased to 100 patients increased)	⨁⨁◯◯ Low	Critical
Complications (event occurrences): early complications (leaks). While other outcomes are also possible, we used leaks at the insertion site as the representative.
7	RCT	Serious ^a	Serious ^d	Not serious	Serious ^c	None	14/288 (4.9%)	23/283 (8.1%)	RR 0.86 [0.25–3.02]	11 patients decreased per 1000 patients (61 decrease to 164 patients increased)	⨁◯◯◯ Very low	Critical
Complications (event occurrences): late complications (hernia) <we judged hernia to be an important late complication, and other infections as separate outcomes>
4	RCT	Very serious ^e	Not serious	Not serious	Serious ^c	None	4/196 (2.0%)	6/195 (3.1%)	RR 0.75 [0.21–2.72]	8 patients decreased per 1000 patients (24 decrease to 53 patients increased)	⨁◯◯◯ Very low	Critical
Complications: PD catheter infections (exit site tunnel infections) <because peritonitis has many other factors, we decided it was not useful for this decision, and used exit site tunnel infections as representative>
4	RCT	Serious ^a	Not serious	Not serious	Serious ^c	None	10/129 (7.8%)	11/133 (8.3%)	RR 0.99 [0.43–2.29]	1 patient decreased per 1000 patients (47 decreased to 107 patients increased)	⨁⨁◯◯ Low	Critical
Abnormalities that require reoperation
1	RCT	Not serious	Not serious	Not serious	Serious ^c	None	8/46 (17.4%)	8/44 (18.2%)	RR 0.96 [0.39–2.33]	7 patients decreased per 1000 patients (111 decreased to 242 patients increased)	⨁⨁⨁◯ Moderate	Critical
QOL (Pain 1)—number of patients who complained of pain (see note 1)
2	RCT	Serious ^f	Not serious	Serious ^g	Serious ^h	None	29/62 (46.8%)	29/65 (44.6%)	RR 1.05 [0.80–1.39]	22 patients increased per 1000 patients (89 patients decreased to 174 patients increased)
QOL (Pain 2)—average pain score
1	RCT	Serious ^f	Not serious	Serious ^g	Serious ⁱ	None	21	24	-	MD decreased by 1 (2.24 decrease to 0.24 increase)	⨁◯◯◯ Very low	Critical
Catheter migration: statistically significant difference was found overall, but a subgroup analysis without securement found no significant difference between groups.
6	RCT	Serious ^a	Not serious	Not serious	Not serious	None	12/267 (4.5%)	31/259 (12.0%)	RR 0.42 [0.18–0.96]	69 patients decreased per 1000 patients (98 patients decreased to 5 patients decreased)	⨁⨁⨁◯ Moderate	Critical

CI, confidence interval; RR, risk ratio; MD, mean difference
^aNo studies were randomized here, so we had to lower it by one grade
^bDue to methods different from those used in Japan and issues with outcome measurement, we lowered both indirectness and bias risk by one grade after thorough consideration
^cThe 2% difference appears to indicate a difference when the intervention is chosen, and we determined that the 95% CI straddles the threshold
^dI² (degree of inter-study variance) was 52%, meaning that the directionality of effects differs between studies, so we lowered inconsistency by one grade
^eDue to the complete absence of randomized studies, we lowered it by two grades
^fMany unclear elements
^gDue to an alternative outcome for QOL
^hThe 10% difference appears to indicate a difference when the intervention is chosen, and we determined that the 95% CI straddles the threshold
ⁱThe details of the pain score are unclear, so we lowered this by 1 grade
^jThere are more than 10 days of difference in hospitalizations between studies; the discharge guidelines appear unclear
^kThe 3-day difference appears to indicate a difference when the intervention is chosen; while the 95% CI does not straddle the threshold, there are not enough cases
Note 1:
Because “events” was classified as the number of patients complaining of pain, even slight pain was counted, indicating a problem with the methods. We have included this for reference only

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ISSN: 2059-1381

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