| Literature DB >> 34389560 |
Stephanie Knippschild1, Jeremias Loddenkemper2, Sabrina Tulka2, Christine Loddenkemper2, Christine Baulig2.
Abstract
OBJECTIVES: Access to full texts of randomised controlled clinical trials (RCTs) is often limited, so brief summaries of studies play a pivotal role. In 2008, a checklist was provided to ensure the transparency and completeness of abstracts. The aim of this investigation was to estimate adherence to the reporting guidelines of the Consolidated Standards of Reporting Trials (CONSORT) criteria for abstracts (CONSORT-A) in RCT publications. PRIMARY ENDPOINT: Assessment according to the percentage of compliance with the 16 CONSORT-A criteria per study.Entities:
Keywords: oral & maxillofacial surgery; oral medicine; statistics & research methods
Year: 2021 PMID: 34389560 PMCID: PMC8365792 DOI: 10.1136/bmjopen-2020-045372
Source DB: PubMed Journal: BMJ Open ISSN: 2044-6055 Impact factor: 2.692
Figure 1Description of the selection procedure and documentation of the number of published RCTs from dental implantology, the aim being a data pool to identify—per criterion and study—the degree of adherence to the CONSORT recommendations for abstracts. Fifty study reports had to be excluded from further investigation and analysis because the clinical indication (n=1) or the study design (n=39) were not compatible or the respective data sets referred to investigations of animals (n=7), were reviews (n=1) or were not identifiable as RCTs (n=2). CONSORT, Consolidated Standards of Reporting Trials; RCTs, randomised controlled trials.
Study characteristics of 212 RCT abstracts of implantology in terms of the frequency (N) and relative frequency (%)
| Study characteristics | Frequencies | |
| Form of abstract | Structured | 174 (82%) |
| Unstructured | 38 (18%) | |
| Year of publication | 2014 | 101 (48%) |
| 2015 | 74 (35%) | |
| 2016 | 37 (17%) | |
| Journals | European Journal of Oral Implantology | 36 (17%) |
| Clinical oral implants research | 36 (17%) | |
| The International Journal of Oral & Maxillofacial Implants | 23 (11%) | |
| Clinical implant dentistry and related research | 22 (11%) | |
| Other | 95 (45%) | |
| Provenance | Europe | 70 (33%) |
| America | 21 (10%) | |
| Africa | 6 (3%) | |
| Asia | 35 (17%) | |
| Not specified | 80 (38%) | |
| Word count (median) | 258 (min. 94; max. 659) | |
| No of cases analysed (median) | 36 (min. 10; max. 360) | |
| Impact factor (median) | 2.3280 (min. 0; max. 5.62) | |
RCT, randomised controlled trial.
Implementation N (%) of CONSORT-A in 212 reports of published RCTs in the field of implantology
| CONSORT criterion | Implementation N (%) | Implementation N (%) |
| Identification as a randomised trial in the title | 95 (45) | 95 (45)* |
| Trial design | 66 (31) | 66 (31)* |
| Participant characteristics | 154 (73) | 154 (73)* |
| Interventions | 212 (100) | 200 (94) |
| Objective | 209 (99) | 209 (99)* |
| Definition primary endpoint | 198 (93) | 117 (55) |
| Randomisation | 35 (17) | 13 (6) |
| Blinding | 41 (19) | 21 (10) |
| Numbers randomised | 97 (46) | 97 (46)* |
| Recruitment | 196 (93) | 196 (93)* |
| Numbers analysed | 57 (27) | 57 (27)* |
| Results of outcome | 207 (98) | 133 (63) |
| Harms | 23 (11) | 23 (11)* |
| Conclusion | 204 (96) | 47 (22) |
| Trial registration | 10 (5) | 10 (5)* |
| Funding | 8 (4) | 8 (4)* |
| Total |
Presentation of the degree of adherence I (information given in the abstract) and degree of adherence II (correct documentation in accordance with CONSORT-A).
*Variables without a formal degree of adherence II.
CONSORT, Consolidated Standards of Reporting Trials; CONSORT-A, CONSORT criteria for abstracts; RCTs, randomised controlled trials.
Figure 2Illustration of the degree of adherence per study (%) in a box plot (n=212). Degree of adherence I (quantitative implementation), degree of adherence II (qualitative implementation).
Figure 3Graphical representation of proportional implementation of criteria to facilitate locating the corresponding information in the abstract (degree of adherence I vs degree of adherence II).