Potential effects of lowering the threshold of statistical significance in the field of chronic rhinosinusitis – A meta-research on published randomized controlled trials over last decade

OBJECTIVE: To evaluate the impact of change in p-value threshold from 0.05 to 0.005, on published Randomized Controlled Trials (RCTs) over the last ten years in the field of chronic rhinosinusitis. METHODS: A search of the PubMed database from 1st January 2011 to 31st December 2020 was conducted to include all RCTs that used p-value to determine the effects of an intervention. Data extracted included p-values, type of intervention, publishing journal with indexing, registration, funding, and multi- or single center status. The proportion of primary endpoints having p < 0.005 was determined first, followed by those with p > 0.005 but <0.05. Logistic regression analysis was used to determine if any trial characteristic was associated with reporting of significant p-values. RESULTS: In total, 168 primary endpoints were identified from 123 RCTs. On analysis, 80 had a p-value <0.05, i.e., statistically significant on conventional parameter. Out of these, 53.75% had a p-value <0.005, which would retain significance under the proposed threshold, and the remaining 46.25% to be reclassified as “suggestive”. None of the trial characteristics were contributing to reporting of conventional or proposed p-values on logistic regression analysis. CONCLUSION: Lowering the p-value threshold would render 46.25% of a decade of published RCTs results (in the field of CRS) to be reclassified as merely “suggestive” and not significant. Trial characteristics were not found contributing to reporting of p-value <0.005 or even <0.05. LEVEL OF EVIDENCE: II.