Critical analysis of the reporting quality of randomized trials within Endodontics using the Preferred Reporting Items for RAndomized Trials in Endodontics (PRIRATE) 2020 quality standard checklist

Abstract

To critically evaluate the reporting quality of a random sample of clinical trials published in Endodontics against the PRIRATE 2020 checklist and to analyse the association between the quality of reported trials and a variety of parameters. Fifty randomized clinical trials relating to Endodontics were randomly selected from the PubMed database from 2015 to 2019 and evaluated by two independent reviewers. For each trial, a score of "1" was awarded when it fully reported each item in the PRIRATE guidelines whereas a score of "0" was awarded when an item was not reported; when the item was reported inadequately a score of "0.5" was awarded. For the items that were not relevant to the trial, "Not Applicable (NA)" was given. Based on the interquartile range of the overall scores received, trials were categorised into "Low" (0-58.4%), "Moderate" (58.5-72.8%) and "High" (72.9-100%) quality. The associations between characteristics and quality of clinical trials were investigated. Descriptive statistics, frequency analysis and percentage analyses were used to describe the data. To determine the significance of categorical data, the Chi-Square test was used. The probability value 0.05 was considered as the level of significance. Based on the overall scores, 13 (26%), 25(50%) and 12 (24% ) of the reports of clinical trials were categorized as "High", "Moderate" and "Low" quality, respectively. Three items (1b, 6d, 11e) were adequately reported in all manuscripts whilst two items (5k, 5m) were scored "NA" in all the reports. The reports published from Europe had a significantly greater percentage of "High" quality scores, compared to Asia, Middle East, North America and South America (p=0.0002). The "High" quality reports were published significantly more often in impact factor journals (p=0.045). Reports of clinical trials published in journals that adhered to the CONSORT guidelines had significantly more "High" scores compared to those that did not (p=0.008). Clinical trials with protocols registered a priori had a significantly greater percentage of "High" scores compared to the trials that were not registered in advance (p=0.003). No significant difference occurred between the quality of clinical trials and the number of authors, journal (Endodontic specialty vs Non-Endodontic specialty) or year of publication. Reports of randomized clinical trials published in the speciality of Endodontics had a substantial number of deficiencies. To create high quality reports of clinical trials, authors should comply with the PRIRATE 2020 guidelines.