Reporting quality of randomized controlled trials in otolaryngology: review of adherence to the CONSORT statement
Abstract Background Randomized controlled trials are the gold standard in medical and surgical research to assess the efficacy of therapeutic interventions. The reporting of these trials should be of high quality to allow readers’ appropriate interpretation and application. Methods The objectives of...
| Main Authors: | , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
BMC
2018-05-01
|
| Series: | Journal of Otolaryngology - Head and Neck Surgery |
| Subjects: | |
| Online Access: | http://link.springer.com/article/10.1186/s40463-018-0277-8 |
| _version_ | 1797972677882806272 |
|---|---|
| author | Yu Qing Huang Katsiaryna Traore Badr Ibrahim Maida J. Sewitch Lily H. P. Nguyen |
| author_facet | Yu Qing Huang Katsiaryna Traore Badr Ibrahim Maida J. Sewitch Lily H. P. Nguyen |
| author_sort | Yu Qing Huang |
| collection | DOAJ |
| description | Abstract Background Randomized controlled trials are the gold standard in medical and surgical research to assess the efficacy of therapeutic interventions. The reporting of these trials should be of high quality to allow readers’ appropriate interpretation and application. Methods The objectives of our study were to assess the extent to which the recent Otolaryngology – Head and Neck Surgery (ORL-HNS) randomized control trials in the top nine journals and in the top Canadian journal comply with the Consolidated Standards of Reporting Trials (CONSORT) statement, and to identify the CONSORT items most in need of improvement. Based on the impact factor and circulation number of 2014, the top nine Otolaryngology journals and the top Canadian Otolaryngology journal were selected and were searched to identify RCTs published in English and between 2010 and 2014. Two authors independently reviewed and extracted data using a standardized data extraction form constructed with the help of a medical librarian. Our outcome was to assess the adherence of articles reporting to the CONSORT items. Descriptive statistics were used. Results One hundred and eighty-two Otolaryngologic RCTs were identified in the top nine international journals and in the top Canadian journal. The inter-rater reliability between two raters was 0.32. The extent of adherence to CONSORT Statement ranged from 25 to 93.5% with a mean of 59.0% and a median of 59.4%. Only 6.5% of RCTs described the individual responsible for enrolling and assigning subjects and method of randomization; 32.4% reported the estimated effect size and precision; 40.6% reported a sample size calculation and 32.4% mentioned external validity or implications of the findings. Conclusion Findings revealed that the reporting of RCTs in the top nine ORL-HNS journals and in the top Canadian ORL-HNS journal is suboptimal. The quality of reporting can be improved by addressing the three CONSORT items found most deficient in this study namely, sample size calculations, estimated effect size and precision, and external validity. |
| first_indexed | 2024-04-11T03:52:19Z |
| format | Article |
| id | doaj.art-bc3120caad5d4c1caab62cafe2df98a1 |
| institution | Directory Open Access Journal |
| issn | 1916-0216 |
| language | English |
| last_indexed | 2024-04-11T03:52:19Z |
| publishDate | 2018-05-01 |
| publisher | BMC |
| record_format | Article |
| series | Journal of Otolaryngology - Head and Neck Surgery |
| spelling | doaj.art-bc3120caad5d4c1caab62cafe2df98a12023-01-02T01:44:27ZengBMCJournal of Otolaryngology - Head and Neck Surgery1916-02162018-05-014711710.1186/s40463-018-0277-8Reporting quality of randomized controlled trials in otolaryngology: review of adherence to the CONSORT statementYu Qing Huang0Katsiaryna Traore1Badr Ibrahim2Maida J. Sewitch3Lily H. P. Nguyen4Faculty of Medicine, McGill UniversityFaculty of Medicine, McGill UniversityDepartment of Otolaryngology – Head and Neck Surgery, University of MontrealFaculty of Medicine, McGill UniversityDepartment of Otolaryngology – Head and Neck Surgery, McGill UniversityAbstract Background Randomized controlled trials are the gold standard in medical and surgical research to assess the efficacy of therapeutic interventions. The reporting of these trials should be of high quality to allow readers’ appropriate interpretation and application. Methods The objectives of our study were to assess the extent to which the recent Otolaryngology – Head and Neck Surgery (ORL-HNS) randomized control trials in the top nine journals and in the top Canadian journal comply with the Consolidated Standards of Reporting Trials (CONSORT) statement, and to identify the CONSORT items most in need of improvement. Based on the impact factor and circulation number of 2014, the top nine Otolaryngology journals and the top Canadian Otolaryngology journal were selected and were searched to identify RCTs published in English and between 2010 and 2014. Two authors independently reviewed and extracted data using a standardized data extraction form constructed with the help of a medical librarian. Our outcome was to assess the adherence of articles reporting to the CONSORT items. Descriptive statistics were used. Results One hundred and eighty-two Otolaryngologic RCTs were identified in the top nine international journals and in the top Canadian journal. The inter-rater reliability between two raters was 0.32. The extent of adherence to CONSORT Statement ranged from 25 to 93.5% with a mean of 59.0% and a median of 59.4%. Only 6.5% of RCTs described the individual responsible for enrolling and assigning subjects and method of randomization; 32.4% reported the estimated effect size and precision; 40.6% reported a sample size calculation and 32.4% mentioned external validity or implications of the findings. Conclusion Findings revealed that the reporting of RCTs in the top nine ORL-HNS journals and in the top Canadian ORL-HNS journal is suboptimal. The quality of reporting can be improved by addressing the three CONSORT items found most deficient in this study namely, sample size calculations, estimated effect size and precision, and external validity.http://link.springer.com/article/10.1186/s40463-018-0277-8CONSORT adherenceRCTs in otolaryngologyReporting quality |
| spellingShingle | Yu Qing Huang Katsiaryna Traore Badr Ibrahim Maida J. Sewitch Lily H. P. Nguyen Reporting quality of randomized controlled trials in otolaryngology: review of adherence to the CONSORT statement Journal of Otolaryngology - Head and Neck Surgery CONSORT adherence RCTs in otolaryngology Reporting quality |
| title | Reporting quality of randomized controlled trials in otolaryngology: review of adherence to the CONSORT statement |
| title_full | Reporting quality of randomized controlled trials in otolaryngology: review of adherence to the CONSORT statement |
| title_fullStr | Reporting quality of randomized controlled trials in otolaryngology: review of adherence to the CONSORT statement |
| title_full_unstemmed | Reporting quality of randomized controlled trials in otolaryngology: review of adherence to the CONSORT statement |
| title_short | Reporting quality of randomized controlled trials in otolaryngology: review of adherence to the CONSORT statement |
| title_sort | reporting quality of randomized controlled trials in otolaryngology review of adherence to the consort statement |
| topic | CONSORT adherence RCTs in otolaryngology Reporting quality |
| url | http://link.springer.com/article/10.1186/s40463-018-0277-8 |
| work_keys_str_mv | AT yuqinghuang reportingqualityofrandomizedcontrolledtrialsinotolaryngologyreviewofadherencetotheconsortstatement AT katsiarynatraore reportingqualityofrandomizedcontrolledtrialsinotolaryngologyreviewofadherencetotheconsortstatement AT badribrahim reportingqualityofrandomizedcontrolledtrialsinotolaryngologyreviewofadherencetotheconsortstatement AT maidajsewitch reportingqualityofrandomizedcontrolledtrialsinotolaryngologyreviewofadherencetotheconsortstatement AT lilyhpnguyen reportingqualityofrandomizedcontrolledtrialsinotolaryngologyreviewofadherencetotheconsortstatement |