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 Table of Contents  
Year : 2022  |  Volume : 34  |  Issue : 1  |  Page : 22-26

Analysis report of adherence to consort statement for reporting randomized controlled trials (RCTs) Associated with temporomandibular disorders (TMDs): A cross-sectional study

1 Department of Oral Medicine and Radiology, D. Y. Patil Dental School, Lohegaon, Pune, Maharashtra, India
2 Department of Oral Pathology and Microbiology, D. Y. Patil Dental School, Lohegaon, Pune, Maharashtra, India
3 Department of Oral and Maxillofacial Surgery, D Y Patil Dental College and Hospital, D Y Patil Vidyapeeth, Pimpri, Pune, Maharashtra, India
4 Department of Oral and Maxillofacial Surgery, D. Y. Patil Dental School, Lohegaon, Pune, Maharashtra, India
5 Independent Research Consultant, Pune, Maharashtra, India

Date of Submission19-Sep-2021
Date of Decision24-Nov-2021
Date of Acceptance16-Jan-2022
Date of Web Publication25-Mar-2022

Correspondence Address:
Dr. Kalyani Bhate
Professor, Department of Oral and Maxillofacial Surgery, D Y Patil Dental College and Hospital, D Y Patil Vidyapeeth, Pimpri, Pune, Maharashtra
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Source of Support: None, Conflict of Interest: None

DOI: 10.4103/jiaomr.jiaomr_273_21

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Purpose: Temporomandibular disorders (TMDs) and their management are widely sought after by clinicians. They often refer to the reported randomized controlled trials (RCTs) in the literature. The Consolidated Standards of Reporting Trials (CONSORT) statement aims to improve the quality of published RCTs and is endorsed by healthcare journals. Despite the widespread acceptance of CONSORT, its use for reporting clinical trials in the journals remains suboptimal. The purpose of this study was to evaluate, to what extent RCTs related to TMDs have adhered to the CONSORT statement. Methodology: RCTs related to TMDs, published in PubMed from January 2017 to March 2021 were retrieved. Each article was assessed for its adherence to the CONSORT statement by four trained and calibrated investigators. Results: 88 articles were evaluated. Out of 37 items in the checklist, only 4 items demonstrated 100% adherence (item 2a, 2b, 5, 12a, and 16). The most under-reported items were 7a, 8b, 9, 10, 17a, 17b, 19, 23, and 24 (less than 50%). The mean percentage of adherence remained 71.2 ± 12.6. Only one study showed 100% adherence and three studies had less than 50% adherence. Considering adherence of abstract checklist, three items demonstrated 100% adherence (items 4, 5, and 6). Poor reporting was noted with items 8, 13, 15, and 16. The mean percentage of adherence to abstract reporting remained 68.60 ± 11.79. Conclusion: The present study indicates good adherence to CONSORT statement in reporting RCTs related to TMD management. Probably the mandatory instructions from the journals and increasing awareness among the researchers about CONSORT reporting might have done the trick.

Keywords: Adherence, CONSORT statement, randomized controlled trials, temporo-mandibular disorders

How to cite this article:
Shete-Motgi A, Shete M, Bhate K, Kshirsagar K, Kakodkar P. Analysis report of adherence to consort statement for reporting randomized controlled trials (RCTs) Associated with temporomandibular disorders (TMDs): A cross-sectional study. J Indian Acad Oral Med Radiol 2022;34:22-6

How to cite this URL:
Shete-Motgi A, Shete M, Bhate K, Kshirsagar K, Kakodkar P. Analysis report of adherence to consort statement for reporting randomized controlled trials (RCTs) Associated with temporomandibular disorders (TMDs): A cross-sectional study. J Indian Acad Oral Med Radiol [serial online] 2022 [cited 2022 May 27];34:22-6. Available from: https://www.jiaomr.in/text.asp?2022/34/1/22/340753

   Introduction Top

Temporomandibular disorders (TMDs) affect almost 5% to 12% of the population making it the second most common musculoskeletal condition.[1] In general, these constitute of multiple signs and symptoms associated with Temporomandibular joint, masticatory muscles or both.[2] This symptom complex is often managed by multiple specialists like Oral Physicians and Radiologists, Prosthodontists, Orthodontists, Psychiatrists, Physiotherapists and Neurologists. Nevertheless, the management of TMDs is often complex and challenging. There is a continuous quest to identify easy, simple and feasible TMD management technique, and hence researchers are always undertaking clinical experimentations.

Randomized controlled trials (RCTs) are believed to be a rigorous and robust method of research to determine whether a cause–effect relation exists between outcome and intervention and well conducted RCTs are invariably recommended for decision-making in the clinical practice.[3] Literature is replete with RCTs related to TMD management.

To improve the quality of reporting RCTs, there are a variety of checklists available for the researchers including JBI Critical appraisal checklist, Jadad Scale, Modified Jadad Scale, Delphi List, Chalmers Scale, National Institute for Clinical Excellence (NICE) methodology checklist, Downs and Black checklist, and several other tools but these are not commonly used or recommended nowadays.[4] The CONSORT statement remains the most comprehensive and widely accepted tool for reporting RCTs. It was first published in 1996. The latest has been the CONSORT 2010, consisting of a checklist of 25 items that guides reporting of essential items of a RCT. The CONSORT checklist is divided into six sections: title and abstract, introduction, methods, results, discussion, and other information.[5] It addresses the minimum criteria for designing, analyzing and interpreting the trial. Hence, it is a useful tool in the research that allows the researcher to conduct a RCT and the clinician to critically assess the quality of evidence.[6] Despite the widespread acceptance of CONSORT, it is reported by several studies that adherence to CONSORT for the reporting of RCT is poor.[5]

Considering this background, the present study was designed to assess the reporting quality of RCTs regarding management of TMDs by evaluating its adherence to the CONSORT guidelines.

   Materials and Methods Top

The current study was a retrospective, cross-sectional record analysis study not involving human participants. The Institutional Ethics committee of D Y Patil Dental School, Lohegaon, Pune, has permitted exemption from ethical clearance [Certificate no. IECDYPDS/F-02/2021, dated 30-03-2021]. As this was not a systematic review, meta-analysis was not applicable. This study was conducted during 1 April 2021 to 31 July 2021. Inclusion criteria – The scientific publications on the RCTs related to TMDs were retrieved from PubMed (https://pubmed.ncbi.nlm.nih.gov/). The terms used for this search were management of TMD or TMJ disorders and TMD/TMJ management and RCT. The research articles in English published during January 2017 to March 2021 were selected. Exclusion criteria – Other general trials and controlled trials were excluded. In total, 110 articles were retrieved and out of those, 88 unique articles were selected after screening for the title and abstract. 84 articles were from international journals and 4 articles were from a national journal. Out of these, eight random articles were initially evaluated by all four authors for the purpose of standardization as well as calibration of the process. Four authors (AS, MS, KK, and KB) trained themselves to use the CONSORT statement checklist 2010. The areas of disagreement were discussed by all of the authors till a common consensus was reached. Later, each author individually assessed 20 articles. Furthermore, the authors also inspected “Instructions to author” section of the selected journals to check whether the CONSORT reporting was mandatory for the RCT manuscript. The findings were recorded in an excel sheet. Descriptive statistics viz. number percentage, mean, standard deviation, and median were calculated.

   Results Top

A total of 88 articles [Supplementary File 1] were selected from 40 journals. Of the 40 journals, 4 journals did not recommend CONSORT for reporting RCT in the “Instructions to Authors” guidelines [Supplementary File 2].

[Table 1] demonstrates adherence to CONSORT statement data for the 88 articles. Overall, out of the 37 items in the checklist, only 4 items showed 100% adherence (# 2a, 2b, 5, 12a, and 16). The most under-reported items were # 7a, 8b, 9, 10, 17a, 17b, 19, 23, and 24 (less than 50%). Out of the 37 items in the checklist, when individual studies were considered, in general the adherence ranged from 15 to 37 items, with a median of 25 items. The mean percentage of adherence remained 71.2 ± 12.6. There was only one study with 100% adherence and three studies with less than 50% adherence.
Table 1: Percentage of adherence of items of CONSORT for manuscript

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[Table 2] demonstrates adherence to the Abstract checklist of CONSORT for the 88 articles. For only three items 100% adherence was observed (items # 4, 5, and 6). Poor reporting was noted with items #8, 13, 15, and16. While considering individual studies, out of the 16 listed items, adherence ranged from 7 to 16 items per study, with an overall median of 11 items. The mean percentage of adherence remained at 68.60 ± 11.79.
Table 2: Percentage of adherence of items of CONSORT for abstract

Click here to view

   Discussion Top

Results from RCTs have direct impact on patient care and outcomes, and hence, accurate and complete reporting of the design, conduct, analysis, and generalizability of the trial should be there.[7] The RCT protocol should be planned methodically and their outcomes should be reported clearly.[8] Well-designed, well-conducted, and well-reported RCTs provide the most unbiased data for reducing uncertainties around the effects of an outcome of interest and for improving the reliability of findings.[5] The clinicians often refer to previous interventional studies for guidance and ease of conducting studies.[9],[10],[11],[12],[13],[14],[15]

RCTs on TMD management from 2017 to 2021 have indicated a mean adherence of 71% to the CONSORT statement as revealed by the results of the present study. This is in consensus with the study by Fricton et al.,[16] who carried out critical appraisal of methods used in RCTs of treatments for TMDs and indicated that there was improvement in the quality of RCTs. Diversely, Abeer-A Al-Namankany et al.[17 reported that quality of reporting of RCTs between 1985 and 2006 in Pediatric dentistry journals was poor and ever since the development of CONSORT statement, the reporting of RCTs is improved. Recent study indicate that most of the RCTs on the prevention of occlusal caries have followed the CONSORT guidelines.[18]

Conversely, there are studies which imply that the reporting of clinical trials in journals remains poor.[19 Little improvement is seen in reporting of RCTs related to restorative dentistry in spite of endorsement of CONSORT.[20] Publications regarding RCTs on mandibular third molar in PubMed from 2015 to 2020 did not show 100% adherence to the CONSORT guidelines.[21] RCTs on Medical Informatics-Clinical Decision Support showed overall reporting quality to be low.[22] Additionally, suboptimal reporting of RCTs in the medical field has also been observed by various authors like Nagendran M et al.,[23] and Hopewell S et al.[24] Such poor adherence to CONSORT leads to insufficient clarity, confusion, reduced transparency, difficulty in reproducibility, questionable validity of the study and compromised interpretation of the results. Poorly reported RCTs fail to help the clinicians to guide for implementation of various management modalities.[21]

Each item mentioned in the CONSORT statement holds a special significance.[25] Abstract of the article, is very important for the readers.[26] The article searches and initial evaluation is made usually by reading the abstract. In the present study, 68.6% adherence was observed for the CONSORT abstract checklist. The areas of poor reporting were blinding status (#8), harms (#13), trial registration (#15), and funding (#16). These items were also found to be under reported in an earlier study.[21] The cause for this may be the word limit specifications by the journals. Most of the times, it is restricted to around 250–300 words and authors might find it difficult to mention all the details.

Overall reporting adherence of 71% was noted. The under-reported items in the present study were 7a, 8b, 9, 10, 17a, 17b, 19, 23, and 24. Sample size calculation (#7a) is very important as no study can be initiated without knowing the number of participants. The authors should give the details for assessing the authenticity and, relevance to statistical as well as clinical significance. Randomization (# 8, 9, 10) is one of the most important aspect of conducting RCT. The type of randomization and method used to employ the random allocation sequence needs to be mentioned. This will give an idea about bias free distributions of the groups. The calculation of risk difference (#17b) is a parameter for depiction of clinical significance and also for population generalization. It is necessary to mention this estimation when it is a binary outcome. When treating the patients, the most vital aspect for clinicians is to know about the harms (#19) caused to the participants. Being a primary responsibility, the clinicians should be able to avoid or minimize harms while providing maximum benefit to the patients. The registration of all the interventional trials is a scientific, ethical, and moral responsibility[27] and the author should provide trial number and name of trial registry (#23). The ICMJE (International Committee of Medical Journal Editors) gives guidance on acceptable registries (www.icmje.org/faq.pdf). A full accessible protocol (#24) pre-specifies methodology of the trial and can help to restrict the likelihood of undeclared post hoc changes to the trial. A full protocol proves to be beneficial to the readers and researchers. The authors should make effort to identify several options to make the protocol available.[27]

   Limitation Top

The present study analysis was limited to only TMD studies and considered articles of five years only. Further, the articles from PubMed were only considered. Hence, the results cannot be generalized across the articles published in other databases.

Future study prospects

Time and again, the importance of adherence to CONSORT guidelines for reporting RCTs has been published. Adherence to CONSORT greatly improves inclusivity, standardization of reporting and clarity to the readers. The adherence to CONSORT and overall reporting quality not only depends upon the authors but also on the journal policies. The editor should mandate the peer reviewers to review the RCT manuscript using CONSORT statement. In fact, the peer reviewers should be well versed with the CONSORT statement as their role is very important.[28] A systematic review in 2008 mentioned that adopting the CONSORT by journals has improved the quality of reporting trials.[29] In the future, ICMJE can mandate all the journals to include CONSORT reporting in their “Instruction to Authors” and the indexing bodies can consider this point as an important check mark while granting indexing to the journal. Based on the results of this study, future studies can be planned with a robust study design considering the lacunae of the present study.

   Conclusion Top

The results of the present study indicate an acceptable adherence of TMD studies reporting with CONSORT statement, although 100% is always desirable. With regards to TMD studies, it is admirable as compared to the observations from other studies in the literature. Probably the mandatory instructions from the journals will help achieve the 100% adherence.

Financial support and sponsorship


Conflicts of interest

There are no conflicts of interest.

   Supplementary File 1 Top

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