A Historical Analysis of Randomized Controlled Trials in Rotator Cuff Tears

Vincenzo Candela; Umile Giuseppe Longo; Calogero Di Naro; Gabriella Facchinetti; Anna Marchetti; Gaia Sciotti; Giulia Santamaria; Ilaria Piergentili; Maria Grazia De Marinis; Ara Nazarian; Vincenzo Denaro

doi:10.3390/ijerph17186863

A Historical Analysis of Randomized Controlled Trials in Rotator Cuff Tears

Int J Environ Res Public Health. 2020 Sep 20;17(18):6863. doi: 10.3390/ijerph17186863.

Affiliations

¹ Department of Orthopedic and Trauma Surgery, Campus Bio-Medico University, Trigoria, 00128 Rome, Italy.
² Department of Orthopedic and Trauma Surgery, Research Unit Nursing Science, Campus Bio-Medico University, Trigoria, 00128 Rome, Italy.
³ Carl J. Shapiro Department of Orthopaedic Surgery and Center for Advanced Orthopaedic Studies, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA 02215, USA.

Abstract

Background and objectives: Our research aimed to evaluate the quality of reporting of randomized controlled trials (RCTs) linked to rotator cuff (RC) tears. The present study analyzed factors connected to the quality of the RCTs and trends in the quality of reporting through time. Materials and Methods: The online databases used to search all RCTs on the topic of RC surgery completed until March 2020 were PubMed and Ovid (MEDLINE). The quality of reporting was evaluated using the modified Coleman methodology score (MCMS) and the consolidated standards of reporting trials (CONSORT). Results: The online search found 957 articles. Finally, 183 studies were included in the quantitative synthesis. A total of 97 (53%) of 183 studies had a level of evidence I and 86 (47%) of 183 studies had a level of evidence II, according to the Oxford Center of Evidence Based Medicine (EBM). A statistically significant difference in MCMS between articles written before 2010 and articles written after 2010 was found. Articles written after 2010 had, on average, the highest Coleman score. The average number of CONSORT checklist items for each article across all analyzed RCTs was 21.67. The 37 studies completed up to 2010 averaged a number of checklist items of 19.97 and the studies completed between 2011 and 2019 averaged a number of checklist items of 22.10. A statistically significant difference in the number of checklist items between articles written before 2010 and articles written after 2010 was found. Articles written after 2010 had on average more checklist items. However, low correlation (0.26) between the number of checklist items for each article and the respective Coleman score was found. On the other hand, articles with the CONSORT diagram had a significantly high Coleman score. Conclusions: An improvement in the quantity and quality of RCTs relating to RC surgery over the analyzed period was found.

Keywords: consolidated standards of reporting trials; modified Coleman methodology score; quality; randomized controlled trial; rotator cuff tear.

Publication types

Review

MeSH terms

Checklist
Evidence-Based Medicine
Humans
Randomized Controlled Trials as Topic / standards
Rotator Cuff Injuries* / therapy
Rotator Cuff* / surgery