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. 2021 May 25;7(2):221-241.
doi: 10.3233/BLC-201510. eCollection 2021.

A Systematic Review of Outcome Reporting, Definition and Measurement Heterogeneity in Non-Muscle Invasive Bladder Cancer Effectiveness Trials of Adjuvant, Prophylactic Treatment After Transurethral Resection

Erik Veskimae  1 , Selvarani Subbarayan  2 , Riccardo Campi  3   4 , Domitille Carron  5 , Muhammad Imran Omar  2 , Cathy Yuan  6 , Konstantinos Dimitropoulos  2   7 , Mieke Van Hemelrijck  8 , Richard T Bryan  9 , James N'Dow  2   7 , Marek Babjuk  10 , J Alfred Witjes  11 , Richard Sylvester  12 , Steven MacLennan  2
Affiliations

A Systematic Review of Outcome Reporting, Definition and Measurement Heterogeneity in Non-Muscle Invasive Bladder Cancer Effectiveness Trials of Adjuvant, Prophylactic Treatment After Transurethral Resection

Erik Veskimae et al. Bladder Cancer. .

Abstract

Background: Heterogenous outcome reporting in non-muscle-invasive bladder cancer (NMIBC) effectiveness trials of adjuvant treatment after transurethral resection (TURBT) has been noted in systematic reviews (SRs). This hinders comparing results across trials, combining them in meta-analyses, and evidence-based decision-making for patients and clinicians.

Objective: We aimed to systematically review the extent of reporting and definition heterogeneity.

Methods: We included randomized controlled trials (RCTs) identified from SRs comparing adjuvant treatments after TURBT or TURBT alone in patients with NMIBC (with or without carcinoma in situ) published between 2000-2020. Abstracts and full texts were screened independently by two reviewers. Data were extracted by one reviewer and checked by another.

Results: We screened 807 abstracts; from 15 SRs, 57 RCTs were included. Verbatim outcome names were coded to standard outcome names and organised using the Williamson and Clarke taxonomy. Recurrence (98%), progression (74%), treatment response (in CIS studies) (40%), and adverse events (77%) were frequently reported across studies. However, overall (33%) and cancer-specific (33%) survival, treatment completion (17%) and treatment change (37%) were less often reported. Quality of Life (3%) and economic outcomes (2%) were rarely reported. Heterogeneity was evident throughout, particularly in the definitions of progression and recurrence, and how CIS patients were handled in the analysis of studies with predominantly papillary patients, highlighting further issues with the definition of recurrence and progression vs treatment response for CIS patients. Data reporting was also inconsistent, with some trials reporting event rates at various time-points and others reporting time-to-event with or without Hazard Ratios. Adverse events were inconsistently reported. QoL data was absent in most trials.

Conclusions: Heterogenous outcome reporting is evident in NMIBC effectiveness trials. This has profound implications for meta-analyses, SRs and evidence-based treatment decisions. A core outcome set is required to reduce heterogeneity.

Patient summary: This systematic review found inconsistencies in outcome definitions and reporting, pointing out the urgent need for a core outcome set to help improve evidence-based treatment decisions.

Keywords: Outcome reporting heterogeneity; TURBT; core outcome sets; non-muscle-invasive bladder cancer (NMIBC); systematic review.

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Conflict of interest statement

Erik Veskimae – Has no conflict of interest to report. Selvarani Subbarayan – Has no conflict of interest to report. Riccardo Campi – Has no conflict of interest to report. Domitille Carron – Has no conflict of interest to report. Muhammad Imran Omar – Has no conflict of interest to report. Cathy Yuan – Has no conflict of interest to report. Konstantinos Dimitropoulos – Has no conflict of interest to report. Mieke Van Hemelrijck – Has no conflict of interest to report. Richard T. Bryan – Reports other from Janssen EMEA, grants from UroGen Pharma, grants from QED Therapeutics, outside the submitted work. James N’Dow – Has no conflict of interest to report. Marek Babjuk – Has no conflict of interest to report. J. Alfred Witjes – Has no conflict of interest to report. Richard Sylvester – Has no conflict of interest to report. Steven MacLennan – Has no conflict of interest to report.

Figures

Fig.1
Fig.1
Preferred Reporting Items for Systematic Reviews (PRISMA) diagram of studies. SR, systematic review; RCT, randomized controlled trial.
See this image and copyright information in PMC

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