Table 1.

Reasons for excluding PRO articles

Non-randomised studies	Inclusion criteria				Requirements to contain high risk of bias				Comments
	P	I	C	O	Response ≥70%	Baseline each group	Baseline comparable/or adjusted	Statistical comparison between groups
Bacon et al29	Yes	Yes	No	–	–	–	–	–	No concurrent group
Ball et al30	Yes	Yes	No	–	–	–	–	–	Cryotherapy
Befort et al31	Yes	Yes	Yes	Yes	No	–	–	–	Low response
Bergman et al32	Yes	Yes	Yes	Yes	Yes	Yes	Yes	No	No appropriate test
Bergman et al33	Yes	Yes	Yes	Yes	No	–	–	–	Low response
Brandeis et al34	Yes	No	–	–	–	–	–	–	29% LDR-BT+EBRT
Brown et al35	Yes	No	–	–	–	–	–	–	EBRT
Burnett et al36	Yes	Yes	Yes	Yes	No	–	–	–	Response not reported
Chaikin et al37	No	–	–	–	–	–	–	–	Staging not reported
Chen et al38	Yes	Yes	Yes	Yes	Yes	Yes	No	–	No confounder control
Choo et al39	Yes	Yes	Yes	Yes	Yes	No	–	–	Baseline not reported
Clark et al40	Yes	Yes	Yes	Yes	No	–	–	–	Low response
Downs et al41	Yes	Yes	Yes	Yes	Yes	Yes	No	–	No confounder control
Eton et al42	Yes	Yes	Yes	Yes	No	–	–	–	Low response
Frank et al43	Yes	Yes	Yes	Yes	No	–	–	–	Low response
Fulmer et al44	Yes	Yes	Yes	Yes	No	–	–	–	Response not reported
Gore et al45	Yes	Yes	Yes	Yes	No	–	–	–	Low response
Guedea et al46	Yes	Yes	Yes	Yes	Yes	Yes	No	–	No confounder control
Hashine et al47	Yes	Yes	Yes	Yes	Yes	Yes	No	–	No confounder control
Hashine et al48	Yes	Yes	Yes	Yes	Yes	Yes	No	–	No confounder control
Hervouet et al49	No	–	–	–	–	–	–	–	≥20% T3–T4 in control groups
Hollenbeck et al50	Yes	No	–	–	–	–	–	–	LDR-BT+EBRT
Jo et al51	Yes	No	–	–	–	–	–	–	High-dose rate brachytherapy
Johnstone et al52	Yes	No	–	–	–	–	–	–	EBRT
Joly et al53	Yes	No	–	–	–	–	–	–	LDR-BT+EBRT
Kakehi et al54	Yes	Yes	Yes	Yes	Yes	No	–	–	Baseline not reported
Lev et al55	Yes	No	–	–	–	–	–	–	LDR-BT+EBRT
Lilleby et al56	Yes	No	–	–	–	–	–	–	EBRT
Litwin et al57	Yes	Yes	Yes	Yes	No	–	–	–	Low response
Litwin et al58	Yes	No	–	–	–	–	–	–	25% LDR-BT+EBRT
Mehta et al59	Yes	Yes	Yes	No	–	–	–	–	“Fear of cancer”*
Miller et al60	Yes	No	–	–	–	–	–	–	44% LDR-BT+EBRT
Miller et al61	Yes	Yes	Yes	Yes	Yes	No	–	–	Baseline not reported
Monahan et al62	Yes	Yes	Yes	Yes	No	–	–	–	Low response
Namiki et al63	Yes	Yes	Yes	Yes	No	–	–	–	Low response
Namiki et al64	Yes	Yes	Yes	Yes	No	–	–	–	Low response
Ohashi et al65	Yes	Yes	Yes	Yes	No	–	–	–	Low response
Pinkawa et al66	Yes	Yes	No	–	–	–	–	–	LDR-BT+hormones†
Roach et al67	Yes	No	–	–	–	–	–	–	EBRT, single-arm trial
Sanda et al68	Yes	Yes	Yes	Yes	No	–	–	–	Low response
Schover et al69	Yes	Yes	Yes	Yes	No	–	–	–	Low response
Soderdahl et al70	Yes	Yes	Yes	Yes	No	–	–	–	Low response
Speight et al71	Yes	Yes	Yes	Yes	No	–	–	–	Response not reported
Stone et al72	Yes	Yes	No	–	–	–	–	–	LDR-BT+hormones†
Trojan et al73	Yes	Yes	Yes	Yes	No	–	–	–	Low response
Tward et al74	Yes	Yes	Yes	No	–	–	–	–	Mortality differs§
Valicenti et al75	Yes	Yes	Yes	Yes	No	–	–	–	Response not reported
Van de Poll- Franse et al76	Yes	No	–	–	–	–	–	–	LDR-BT+EBRT
Wyler et al77	Yes	Yes	Yes	Yes	Yes	Yes	No	–	No confounder control
Zagar et al78	Yes	No	–	–	–	–	–	–	LDR-BT+EBRT
‘NO’ counts	2	13	4	2	19	3	6	1	Total: 50 studies
	PICO not met: 21				High risk of bias: 29

–: not appropriate.

*Mehta et al⁵⁹: no appropriate endpoint.

†Pinkawa et al⁶⁶; Stone et al⁷²: neoadjuvant hormonal therapy.

§Tward et al⁷⁴: non-disease-related mortality differs greatly.C, comparison of interest is radical prostatectomy, external beam radiotherapy, or no primary therapy; EBRT, external beam radiotherapy; I, intervention of interest is low-dose rate brachytherapy as monotherapy; LDR-BT, permanent interstitial low-dose rate brachytherapy; O, outcome of interest is function, bother, or generic health-related quality of life; P, patients with localised prostate cancer; PRO, patient-reported outcomes.