Neuzillet 2014.
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 + WL‐TURBT followed by BLC + BL‐TURBT Comparator: WLC followed by WL‐TURBT Adjuvant instillation therapy: NA |
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Outcomes | Outcome(s)
Results
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Funding sources | NA | |
Declarations of interest | NA | |
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: "based on a computer‐generated random sequence (1:1), sequentially numbered individual sealed envelopes were prepared by an independent statistician with the group the relevant patient was to be assigned, i.e., a first TURB with WLC and PDD (hexaminolevulinate [HAL]arm) or WLC alone (control arm). Randomization was done the day before the first TURB." Comment: method of sequence generation clearly described |
Allocation concealment (selection bias) | Unclear risk | Quote: "based on a computer‐generated random sequence (1:1), sequentially numbered individual sealed envelopes were prepared by an independent statistician with the group the relevant patient was to be assigned, i.e., a first TURB with WLC and PDD (hexaminolevulinate [HAL]arm) or WLC alone (control arm). Randomization was done the day before the first TURB" Comment: allocation concealment unclear |
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 | Low risk | Quote: "excluded from follow‐up n=2 and n=2, respectively (see figure)" Comment: low rate of participants (< 10%) 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 |