Geavlete 2012.
Study characteristics | ||
Methods |
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Participants | Study setting
Eligibility criteria
Non‐eligibility criteria
Intervention cohort
Comparator cohort
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Interventions | Intervention: WLC + BLC followed by WL‐TURBT + BL‐TURBT Comparator: WLC followed by WL‐TURBT Adjuvant instillation therapy: mitomycin C (no further information on dosage) |
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Outcomes | Outcome(s)*
Results
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Funding sources | NR | |
Declarations of interest | 1 author: received honoraria from GE Healthcare when spoke at a company‐sponsored symposia | |
Contact of study author | Date of contact attempt to first study author: 30 November 2020 Contact status: no reply to date |
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Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "randomized by means of sealed envelopes, thus ensuring allocation concealment by the ‘sequentially‐numbered, opaque, sealed envelopes’ method" Comment: method of sequence generation clearly described |
Allocation concealment (selection bias) | Low risk | Quote: "randomized by means of sealed envelopes, thus ensuring allocation concealment by the ‘sequentially‐numbered, opaque, sealed envelopes’ method" Comment: allocation concealment clearly described |
Blinding of participants and personnel (performance bias) Surgeon | High risk | Quote: "in each case, the urologist performing the procedure was informed on whether HAL‐BLC would be available only after finishing the WLC to ensure maximum attention to the standard investigation" 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: "to ensure the complete objectivity of the evaluation, the urologists performing the follow‐up of WLCs were unaware of the diagnostic and treatment modality initially applied in each case" Comment: blinding of study personnel reported only at the time point of WLCs |
Incomplete outcome data (attrition bias) Oncological outcomes | Unclear risk | Quote: "during the follow‐up period, 17 patients in the HAL‐BLC arm and 13 in the WLC arm did not complete the 2 years protocol and were consequently excluded from the trial." Comment: unclear rate (10% to 20%) of participants lost to follow‐up |
Selective reporting (reporting bias) | Unclear risk | Quote: NA Comment: no protocol available |
Other bias | Low risk | Quote: NA Comment: no other bias identified |