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. 2021 Dec 1;2021(12):CD013776. doi: 10.1002/14651858.CD013776.pub2

O’Brien 2013.

Study characteristics
Methods
  • randomized, non‐blinded

  • single center/United Kingdom

Participants Study setting
  • primary


Eligibility criteria
  • patients with suspected new NMIBC


Non‐eligibility criteria
  • suspicion of MIBC

  • previous BCa

  • porphyria

  • pregnancy

  • sensitivity 5‐ALA


Intervention cohort
  • participants recruited: 129

  • unifocal/multifocal tumors: 55/70/not stated: 4


Comparator cohort
  • participants recruited: 120

  • unifocal/multifocal tumors: 36/79/not stated: 5

Interventions Intervention: WLC + BLC followed by WL‐TURBT + BL‐TURBT
Comparator: WLC followed by WL‐TURBT
Adjuvant instillation therapy: 40 mg mitomycin C in 40 mL saline
Outcomes Outcome(s)
  • recurrence‐free survival


Results
  • median follow‐up: 12 months

  • RFS rate at 12 months was 16% in intervention group and 22% in comparator group

Funding sources NR
Declarations of interest 2 authors: speaker for GE Healthcare; 1 author: speaker for Photocure; 1 author: speaker for Ipsen
Contact of study author Date of contact attempt to first study author: 30 November 2020
Contact status: no reply to date
Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: "randomization was performed in the urology department of Guy’s Hospital by means of sealed envelopes in blocks of 20"
Comment: method of sequence generation clearly described
Allocation concealment (selection bias) Low risk Quote: "randomization was performed in the urology department of Guy’s Hospital by means of sealed envelopes in blocks of 20"
Comment: allocation concealment clearly described
Blinding of participants and personnel (performance bias)
Surgeon High risk Quote: NA
Comment: surgeon unblinded
Blinding of participants and personnel (performance bias)
Participants/study personnel Unclear risk Quote: NA
Comment: unclear whether study participants and other study personnel were blinded
Blinding of outcome assessment (detection bias)
Subjective outcomes (all outcomes) Unclear risk Quote: NA
Comment: unclear whether study personnel were blinded
Incomplete outcome data (attrition bias)
Oncological outcomes Unclear risk Quote: "excluded from follow‐up see figure 3"
Comment: unclear rate (10% to 20%) of participants lost to follow‐up
Selective reporting (reporting bias) Low risk Quote: NA
Comment: reporting according to the protocol (ISRCTN14275387) of primary outcome measure (recurrence rate of bladder tumor at 3 months and 12 months postsurgery) and secondary outcome measures (analysis of histology)
Other bias Low risk Quote: NA
Comment: no other bias identified