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ORIGINAL ARTICLE
Year : 2020  |  Volume : 10  |  Issue : 2  |  Page : 152-156

Are endodontic abstracts of published randomized clinical trials reported adequately?


1 Department of Restorative Dental Sciences, College of Dentistry, King Saud University, Riyadh 11545, Saudi Arabia
2 Department of Preventive Dental Sciences, College of Dentistry, Prince Sattam Bin Abdulaziz University, Al-Kharj 11942, Saudi Arabia
3 Department of Conservative Dental Sciences, College of Dentistry, Prince Sattam Bin Abdulaziz University, Al-Kharj 11942, Saudi Arabia

Date of Submission22-Sep-2019
Date of Decision28-Oct-2019
Date of Acceptance09-Nov-2019
Date of Web Publication23-Apr-2020

Correspondence Address:
Dr. Fahd A Aljarbou
Department of Restorative Dental Sciences, College of Dentistry, King Saud University, Riyadh
Saudi Arabia
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/sej.sej_143_19

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  Abstract 

Introduction: The aim is to assess the randomized clinical trials reporting quality of abstract in two main endodontic journals and their adherence with the Consolidated Standards of Reporting Trials (CONSORT) guidelines.
Materials and Methods: A hand search looking for all randomized clinical trials published in two endodontic journals; the International Endodontic Journal (IEJ) and the Journal of Endodontics (JOE) from 2012 to 2019; was carried out. A modified CONSORT abstracting checklist was followed and the data were analyzed descriptively.
Results: A total of 140 abstracts gathered and distributed as 18% in the IEJ and 82% in the JOE. The overall mean score for reporting quality was 49.7%. There was 100% checklist score in authors' details, objectives, interventions, outcome, and conclusion. Deficient reporting in the randomization procedures, blinding, and allocation concealment was present in most of the abstracts. There was no mention of registrations and funding sources in any included abstract.
Conclusions: The randomized clinical trials reporting quality of abstract in endodontic journals are suboptimal. More adherence to the CONSORT guidelines is recommended.

Keywords: Abstracts, endodontic journal, endodontics, evidence-based dentistry, randomized clinical trials


How to cite this article:
Aljarbou FA, Alharbi F, Alamri HM. Are endodontic abstracts of published randomized clinical trials reported adequately?. Saudi Endod J 2020;10:152-6

How to cite this URL:
Aljarbou FA, Alharbi F, Alamri HM. Are endodontic abstracts of published randomized clinical trials reported adequately?. Saudi Endod J [serial online] 2020 [cited 2020 Jun 3];10:152-6. Available from: http://www.saudiendodj.com/text.asp?2020/10/2/152/283138


  Introduction Top


As science is currently advancing at a high pace, and considering the enormous amount of research published annually, randomized clinical trials are on top of biomedical evidence;[1] however, the trials' critical findings and application in practice depend on its validity, which relies on the adoption of an adequate methodology, study design, and interpretation of the findings. The high-quality reporting of each component is essential for controlling randomized clinical trials' internal validity.[2]

Currently, all journals require a limited number of words in the abstract section, leading the authors to compromise the quality of reporting. However, the abstract is an essential component of the published article as it serves as the foundation of initial screening in any systematic review. In the hierarchy of evidence, the only type of research that is considered to have higher evidence than randomized clinical trials is systematic reviews and meta-analysis.[3] This type of exhaustive research is based on screening a considerable number of published articles to include or exclude them in the review, and this screening process relies solely on the abstract section.

In regard to quality assessment, the use of an objective scale becomes essential to avoid bias in assessment; therefore, multiple objective scales, including different markers and checklists, were designed to serve this purpose.[4] In a systematic review, 21 scales to assess the quality of randomized clinical trial studies were found;[5] however, not all were valid and reliable. Because of these discrepancies, the Consolidated Standards of Reporting Trials (CONSORT) statement was presented.[6] The CONSORT was developed to update the guidelines for reporting randomized clinical trial studies, which will improve the reporting quality of research in the medical researches (www.consort-statement.org). Currently, there are 585 journals that adopt CONSORT, which represents more than half of the main medical journals listed in the Abridged Index Medicus on PubMed. The latest CONSORT update regarding the abstract reporting of the studies includes reporting of 25 essential items.[7]

The reporting quality of randomized clinical trials in the medical researches was investigated in regard to their methodologies and results; it was concluded that there is an inadequate correlation between the quality of the trial studies and its being reported.[8],[9] Another investigation was conducted to assess the abstract reporting quality of studies published in dental journals, and it was found that the abstract reporting is suboptimal under the CONSORT guidelines.[10] Therefore, the recommendation to abide to the CONSORT guidelines was published to further control the quality of published studies.[11]

The study is aiming to assess the published randomized clinical trials reporting quality of abstract in two main endodontic journals and their adherence with the CONSORT guidelines as well as to note the areas that need improvement in published randomized clinical trials studies in endodontic journals.


  Materials and Methods Top


Two main endodontic journals, i.e. the International Endodontic Journal (IEJ) and the Journal of Endodontics (JOE), were selected based on their high impact factor scores. A hand search was done to find out all randomized clinical trials published in these endodontic journals from January 2012 to June 2019. Human trials were included, while laboratory trials, in vitro, and conference abstracts were excluded. Articles having these keywords “randomized controlled trial,” “assigned,” “prospective,” or “comparative” were screened in the title and abstract, and then, full text was retrieved for the included papers that have one or more of these terms. A literature search was independently done and in duplicate by two authors. Disagreement was disbanded by an open discussion between the two authors. All the potential studies were examined through a piloted extraction sheet. Using the CONSORT abstract items guidelines, a score value was assigned accordingly.[7] Any item that fulfill the checklist get scored as Yes or No if not fulfilling. An item was considered as not applicable (NA) if the trial protocol made it impossible to include. The overall score for each trial was counted and converted to a percentage following this formula: Total score = (total number of “Yes”/[19(total number of “NA” items)])/100.

Further information such as author's count, the continent and country of first author, and clinical protocol of the research was also registered for each article. A pilot study used to calibrate the examiners by examining a randomly selected 10% of the included trial twice with 3 months in between readings. The examiners were directly referring to the CONSORT checklist [Figure 1] and related explanations.
Figure 1: Consolidated Standards of Reporting Trials items checklist for abstracts to include when reporting a randomized clinical trial

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Statistical analysis

Data presented descriptively as counts and percentages in compliance with the CONSORT items checklist. Due to the limited number and unbalanced cohort of trials apart from tabulations, statistical analyses were not performed among the variant. SPSS version 22.00 (Stata Corp., College Station, TX, USA) was used to generate the stats and tables.


  Results Top


At the start of 2012 until June 2019, 140 randomized clinical trials were identified out of 3566 articles (approximately 4% of published articles) in the two main journals in endodontics [Table 1]. Two-thirds of the published studies were coming from Asia and Europe, 40.7% and 25.7%, respectively, while Africa represented 1.4% of the total. There were no randomized clinical trials conducted in Australia. The JOE had the majority of published studies [Table 1].
Table 1: The abstract reporting characteristics of 140 randomized clinical trials published in the two leading endodontic journals

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In accordance to the distributional characteristics related to the first author, most of the included randomized clinical trials studies were done in academic setting (86%) and two-thirds of the included trials (66%) had 4–6 authors, but only a small number of randomized clinical trials formally included the involvement of a statistician in the trials (5%) [Table 2].
Table 2: Number and percentage of included abstracts in accordance to the distributional characteristics related to the first author

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The overall mean CONSORT score was 49.7% (95% confidence interval [CI]: 48.1–51.3). It ranged from 42.9% to 57.9% [Figure 2]. With little differences, studies having fewer than four authors got the highest mean score (mean = 51.5, 95% CI: 47.3–55.6). Despite the limited number of African trial, it scored the highest reporting quality (mean score 63.2, 95% CI: 58.0–68.4), while Asia scored the least (mean score 48.3, 95% CI: 45.7–50.8) [Table 1].
Figure 2: Mean Consolidated Standards of Reporting Trials score according to the year of publication

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With regard to the CONSORT items, most abstracts (80–100%) adequately reported the study title, contact details of the authors, the trial design, reporting the interventions, outcome (s), objective (s), and conclusions. However, there was lack of abstract reporting 4%–46% in the characteristic and participants count and their recruitment status, number of the analyzed participants in each group, method of randomization to groups or interventions, and blinding of either clinicians, patients, or assessors. There was no mention for the adverse effect of the intervention (harms), registration of the trial, and source of funds in any of the randomized clinical trials [Table 3].
Table 3: The modified 19 items for Consolidated Standards of Reporting Trial abstract checklist presented in percentages

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Reliability

Bland and Altman plots [Figure 3]a and [Figure 3]b demonstrated the absence of systematic error scoring in the CONSORT checklist. The random error was minimal and considered to be within acceptable limits[2] for both intraexaminer and interexaminer reliability.
Figure 3: (a) Bland–Altman plot for intraexaminer reliability test. (b) Bland–Altman plot for interexaminer reliability test

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  Discussion Top


Quality assessment of research in different fields of medicine and dentistry has been underway for a long time to assure the validity and quality of the published research;[8],[12] because of that history, different scales have been progressed throughout time to enable readers, researchers, reviewers, and editors to assess the quality of published randomized clinical trials. Harrisonet al. developed a simple quantitative scale to assess orthodontic randomized clinical trial studies, and this scale was used to assess published papers in orthodontic journals from 1989 to 1998.[13] Later, after the CONSORT assessment checklist was published, 117 randomized clinical trial studies in orthodontics assessed between 2006 and 2011 were inadequately reported.[14] Another study looked at the studies published in orthodontic journals that have endorsed the CONSORT guidelines for reporting randomized clinical trials studies and observed that despite the guidelines' being endorsed, there was still a deficit in the quality of the reporting papers.[15]

Many researchers have been assessing the quality of randomized clinical trial studies in different areas over the years, and whether in the dental or medical field,[12] they have all concluded that the quality of published work is suboptimal. This conclusion has led many authors to recommend better adherence to the CONSORT guidelines.[4],[8],[16],[17]

A recent study was published assessing the quality of endodontic randomized clinical trials from 1997 to 2012 found poor overall reporting quality. They suggested better adherence with the CONSORT guidelines to raise the quality of papers being published.[16] The primary issue with that study is that most of the assessed randomized clinical trial studies were published before the latest guidelines were issued by the CONSORT in 2010.[7] Moreover, although the study duration is longer than the current study, the number of the reported papers was lower, which may be attributed to their initial search methodology. The search was performed electronically using Mesh terms, and because not all randomized clinical trial studies have complied with the CONSORT guideline that the randomized clinical trial should be mentioned in the title, a number of studies may have been unintentionally excluded. In our study, 17% of the included articles failed to mention in the title that the study is a randomized clinical trial.

The abstract component is very important in any study, and this becomes more critical when a systematic review or a meta-analysis is going to include it.[3] The mean CONSORT score for an abstract included in this study was deemed to be suboptimal (mean score 49.7%), although both journals have endorsed the CONSORT guidelines. The main deficiencies in abstract reporting were observed to be in the reporting of study design as randomized in the titles, method of randomization, blinding of assessor(s), the analyzed participants count in each group, the adverse effect of the intervention (harms), and registration of the trial and source of funds.[10] It was observed that editor's implementation of CONSORT guidelines in abstract reporting of randomized clinical trials may help improve the quality of the study.[9] This improvement was also observed when the qualities of randomized clinical trial studies were assessed before and after implementation of the CONSORT guidelines in the American Journal of Orthodontics and Dentofacial Orthopaedics.[11] There should be more encouragement of better quality reporting of trials at multiple levels, including the international or national level. Locally, few endodontic clinical studies mainly case reports were published and this should encourage researchers to beneficial the current study in structuring any future clinical trials.[18],[19]


  Conclusions Top


This study observed suboptimal abstract reporting quality of the published randomized clinical trials in the two leading endodontic journals, and after reviewing the literature that addressed the adherence to the CONSORT guidelines, it is clear that abstracts of published randomized clinical trials are not complying with the CONSORT guidelines and that greater effort should be made by reviewers and editors to better control abstract reporting.

Financial support and sponsorship

Nil.

Conflicts of interest

There are no conflicts of interest.



 
  References Top

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Concato J, Shah N, Horwitz RI. Randomized, controlled trials, observational studies, and the hierarchy of research designs. N Engl J Med 2000;342:1887-92.  Back to cited text no. 1
    
2.
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Green S. Systematic reviews and meta-analysis. Singapore Med J 2005;46:270-3.  Back to cited text no. 3
    
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Begg C, Cho M, Eastwood S, Horton R, Moher D, Olkin I, et al. Improving the quality of reporting of randomized controlled trials. The CONSORT statement. JAMA 1996;276:637-9.  Back to cited text no. 6
    
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Schulz KF, Altman DG, Moher D, CONSORT Group. CONSORT 2010 statement: Updated guidelines for reporting parallel group randomised trials. BMJ 2010;340:c332.  Back to cited text no. 7
    
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Ghimire S, Kyung E, Kang W, Kim E. Assessment of adherence to the CONSORT statement for quality of reports on randomized controlled trial abstracts from four high-impact general medical journals. Trials 2012;13:77.  Back to cited text no. 8
    
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Hopewell S, Ravaud P, Baron G, Boutron I. Effect of editors' implementation of CONSORT guidelines on the reporting of abstracts in high impact medical journals: Interrupted time series analysis. BMJ 2012;344:e4178.  Back to cited text no. 9
    
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Seehra J, Wright NS, Polychronopoulou A, Cobourne MT, Pandis N. Reporting quality of abstracts of randomized controlled trials published in dental specialty journals. J Evid Based Dent Pract 2013;13:1-8.  Back to cited text no. 10
    
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Pandis N, Shamseer L, Kokich VG, Fleming PS, Moher D. Active implementation strategy of CONSORT adherence by a dental specialty journal improved randomized clinical trial reporting. J Clin Epidemiol 2014;67:1044-8.  Back to cited text no. 11
    
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Sjögren P, Halling A. Quality of reporting randomised clinical trials in dental and medical research. Br Dent J 2002;192:100-3.  Back to cited text no. 12
    
13.
Harrison JE. Clinical trials in orthodontics I: Demographic details of clinical trials published in three orthodontic journals between 1989 and 1998. J Orthod 2003;30:25-30.  Back to cited text no. 13
    
14.
Fleming PS, Buckley N, Seehra J, Polychronopoulou A, Pandis N. Reporting quality of abstracts of randomized controlled trials published in leading orthodontic journals from 2006 to 2011. Am J Orthod Dentofacial Orthop 2012;142:451-8.  Back to cited text no. 14
    
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Bearn DR, Alharbi F. Reporting of clinical trials in the orthodontic literature from 2008 to 2012: Observational study of published reports in four major journals. J Orthod 2015;42:186-91.  Back to cited text no. 15
    
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Lucena C, Souza EM, Voinea GC, Pulgar R, Valderrama MJ, De-Deus G. A quality assessment of randomized controlled trial reports in endodontics. Int Endod J 2017;50:237-50.  Back to cited text no. 16
    
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Pandis N, Polychronopoulou A, Eliades T. An assessment of quality characteristics of randomised control trials published in dental journals. J Dent 2010;38:713-21.  Back to cited text no. 17
    
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Riyahi AM, Saad AY. Lower lip paresthesia as a sequel of mental nerve irritation secondary to periradicular periodontitis. Saudi Endod J 2018;8:55.  Back to cited text no. 18
  [Full text]  
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Bafaqeeh MS, Alqedairi A. Maxillary first premolar with three root canals: Four case reports. Saudi Endod J 2019;9:216.  Back to cited text no. 19
  [Full text]  


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  [Figure 1], [Figure 2], [Figure 3]
 
 
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  [Table 1], [Table 2], [Table 3]



 

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