Login to Access Video or Poster Abstract: MP61-03
Sources of Funding: None

Introduction

Randomized controlled trials (RCTs) are the "gold standard" methodology for determining whether treatment effects are due to chance. The fragility index (FI) is used to determine the number of events that would be required to change significant positive results to non-significant (p>0.05). Herein, we assess the quality of reporting of RCTs in vesicoureteral reflux (VUR) literature using the 2010 CONSORT statement, and for studies with significant positive findings, calculate the FI as a measure of robustness of the results.

Methods

A comprehensive search was conducted through MEDLINE® and Embase® to identify RCTs in VUR literature from 2000-16. Two reviewers independently selected articles, and evaluated them using the 2010 CONSORT checklist. An overall quality of reporting score (OQR) was calculated by dividing the number of checklist items present in each study by the maximum possible score (34) and expressed as a percentage. Studies were classified as low (<40%), moderate (40-70%) and high quality (>70%). A methodological index score (MIS) out of 4 was assigned based on: sample size justification, allocation concealment, randomization method, and blinding of outcome assessors. Of 2052 initial results, 2003 (98%) were excluded because they did not focus on VUR/were not RCTs. After full text screening of 50 articles, we excluded 28 (56%) that did not meet our criteria. For studies reporting significant positive results, we calculated the FI by manually adding events to the group with fewest events until the p value was no longer significant.

Results

Of the 22 included studies, the mean OQR was 45±16% with 9 (41%) identified as low, 11 (50%) as moderate and 2 (9%) as high quality (Table 1). The mean MIS was 1.95±1. There was no difference in OQR between studies published from 2007-16 (n=15) versus those before 2007 (n=7) (41±15% vs. 44±20%, p=0.70) or RCTs with a sample size >100 (n=15) vs. <100 (n=7) (40±15% vs. 46±17%, p=0.41). However, we noted a difference when we compared RCTs with biostatistician support (n=4) vs. those without (n=18) (62±9% vs. 40±14%, p<0.01). 7 studies reported significant positive results making calculation of FI possible. The mean FI was 5.8±5.1 indicating that most studies were fragile. There was no correlation between the OQS and FI. _x000D_

Conclusions

The current OQR in VUR literature is suboptimal. In addition, most FI scores were between 1-5 indicating that only a few events would be required to completely change the results of these studies. Implementation of the CONSORT checklist as a prerequisite for submission of manuscripts may improve the quality of reporting, and calculation of the FI could provide readers with an objective measure of robustness for the reported results.

Funding

None