Glossary for randomized clinical trials

Abstract

Randomized clinical trials are positioned at the highest level of primary clinical evidence, as they are designed to be unbiased with a reduced risk of systematic error. The Consolidated Standards of Reporting Trials (CONSORT) statement was first developed in 1996 to improve the reporting quality of randomized clinical trials with updates being published subsequently. Recently, the Preferred Reporting Items for RAndomized Trials in Endodontics (PRIRATE) 2020 guidelines were developed exclusively for the field of Endodontics to address the suboptimal quality of randomized clinical trials submitted to Endodontic journals, which result in many being rejected. A principal flaw in submissions is the fact that many authors are unclear on the keys terms that should be used when developing manuscripts for publication. Clearly, authors should be aware of the most common terms used when conducting and reporting randomized clinical trials. Hence, the aim of the current paper is to present a comprehensive glossary of the terminology used in randomized clinical trials in order to assist authors when designing, executing and writing‐up randomized clinical trials.

Effectiveness of pulpotomy compared with root canal treatment in managing non‐traumatic pulpitis associated with spontaneous pain: A systematic review and meta‐analysis

“…All studies performed a randomization process to ensure an equal chance for the participants to be enrolled in either intervention or control groups. There was also allocation concealment preventing any knowledge of the selection process (Nagendrababu, Duncan, Pulikkotil, & Dummer, 2021). The postoperative pain was self‐assessed by participants, avoiding any bias in the measurement of this outcome.…”

Outcome measures to assess the effectiveness of endodontic treatment for pulpitis and apical periodontitis for use in the development of European Society of Endodontology (ESE) S3 level clinical practice guidelines: a protocol

“…Measurable changes in disease, health, function or quality of life that evaluate the effectiveness of an intervention or exposure. Primary outcomes represent the most critical measures addressing the research question, whilst secondary outcomes assist in the interpretation and understanding of the primary outcome (Nagendrababu et al 2021).…”

“…Primary outcomes represent the most critical measures addressing the research question, whilst secondary outcomes assist in the interpretation and understanding of the primary outcome (Nagendrababu et al . 2021).…”

Effectiveness of Educational Interventions for Fall Prevention: A Systematic Review

“…Regarding randomization, the studies included in this review used standardized techniques, from the use of computational algorithms to the use of sealed envelopes. It is emphasized that the study by Harper 21 describes, in the method, quasi-randomization, however, it was included because it presents three basic criteria to be considered RCT, which are: randomization, control and intervention 31 .…”