Still to ARRIVE at adequate reporting of orthodontic studies involving animal models.

BACKGROUND: The ARRIVE 2.0 guidelines were introduced to improve the reporting of animal studies. The aim of this study was to assess the reporting adherence of orthodontic speciality animal studies in relation to ARRIVE 2.0 guidelines. Associations between the reporting and study characteristics were explored. MATERIALS AND METHOD: An electronic database search was undertaken using Medline via PubMed (www.pubmed.ncbi.nlm.nih.gov) to identify studies meeting the eligibility criteria published between 1 January 2018 and 31 December 2023. Data extraction was performed in duplicate and independently. Descriptive statistics and frequency distributions for the responses to each checklist item were calculated. Mean values for adequate reporting per ARRIVE item were calculated. A sum score was calculated by adding the responses (0 = not reported, 1 = inadequate reporting, 2 = adequate reporting) per item and sub-questions. On an exploratory basis, univariable linear regression between summary score and study characteristics (year of publication, continent of authorship, type of centre, and number of authors) was performed. RESULTS: Three hundred and eighty-four studies were analysed. Variability in the adequate reporting of the ARRIVE 2.0 guideline items was evident. In particular, in 32% of studies, there was a lack of reporting of the priori sample size calculation. Overall, the mean reporting score for the sample was 57.9 (SD 6.7 and range 34-74). There were no associations between score and study characteristics except for a weak association for year of publication with a small improvement over time (each additional year). CONCLUSIONS: The reporting of animal studies relevant to the speciality of orthodontics is sub-optimal in relation to the ARRIVE 2.0 guidelines. There was a tendency for the non-reporting of items pertaining to study sample size, eligibility, methods to reduce bias and interpretation/scientific implications. Greater awareness and reporting adherence to the ARRIVE 2.0 guidelines are required to reduce research waste involving animal models.

The OHStat Guidelines for Reporting Observational Studies and Clinical Trials in Oral Health Research: explanation and elaboration.

Adequate and transparent reporting is necessary for critically appraising research. Yet, evidence suggests that the design, conduct, analysis, interpretation, and reporting of oral health research could be greatly improved. Accordingly, the Task Force on Design and Analysis in Oral Health Research-statisticians and trialists from academia and industry-empaneled a group of authors to develop methodological and statistical reporting guidelines identifying the minimum information needed to document and evaluate observational studies and clinical trials in oral health: the OHstat Guidelines. Drafts were circulated to the editors of 85 oral health journals and to Task Force members and sponsors and discussed at a December 2020 workshop attended by 49 researchers. The final version was subsequently approved by the Task Force in September 2021, submitted for journal review in 2022, and revised in 2023. The checklist consists of 48 guidelines: 5 for introductory information, 17 for methods, 13 for statistical analysis, 6 for results, and 7 for interpretation; 7 are specific to clinical trials. Each of these guidelines identifies relevant information, explains its importance, and often describes best practices. The checklist was published in multiple journals. The article was published simultaneously in JDR Clinical and Translational Research, the Journal of the American Dental Association, and the Journal of Oral and Maxillofacial Surgery. Completed checklists should accompany manuscripts submitted for publication to these and other oral health journals to help authors, journal editors, and reviewers verify that the manuscript provides the information necessary to adequately document and evaluate the research.

The OHStat Guidelines for Reporting Observational Studies and Clinical Trials in Oral Health Research: manuscript checklist.

Adequate and transparent reporting is necessary for critically appraising published research. Yet, ample evidence suggests that the design, conduct, analysis, interpretation, and reporting of oral health research could be greatly improved. Accordingly, the Task Force on Design and Analysis in Oral Health Research-statisticians and trialists from academia and industry-identified the minimum information needed to report and evaluate observational studies and clinical trials in oral health: the OHStat Guidelines. Drafts were circulated to the editors of 85 oral health journals and to Task Force members and sponsors and discussed at a December 2020 workshop attended by 49 researchers. The guidelines were subsequently revised by the Task Force's writing group. The guidelines draw heavily from the Consolidated Standards for Reporting Trials (CONSORT), Strengthening the Reporting of Observational Studies in Epidemiology (STROBE), and CONSORT harms guidelines and incorporate the SAMPL guidelines for reporting statistics, the CLIP principles for documenting images, and the GRADE indicating the quality of evidence. The guidelines also recommend reporting estimates in clinically meaningful units using confidence intervals, rather than relying on P values. In addition, OHStat introduces 7 new guidelines that concern the text itself, such as checking the congruence between abstract and text, structuring the discussion, and listing conclusions to make them more specific. OHStat does not replace other reporting guidelines; it incorporates those most relevant to dental research into a single document. Manuscripts using the OHStat guidelines will provide more information specific to oral health research.

Development of 'OXIS Classification' calibration website for dental researchers.

PURPOSE: The variations in interproximal contact areas have been categorised open (O), point (X), straight (I), and curved contact (S). This is based on their shapes and termed as OXIS classification. The interactive OXIS calibration website was developed to assist researchers seeking appropriate knowledge, minimise the overload of material, optimise efficiency in calibration and, to provide repositories for clinicians, healthcare workers, and policymakers. METHODS: The website was developed in two phases. The first phase of development included expert group discussion, Focus Group Discussion (FGD), and the implementation of FGD recommendations. The second phase emphasised registration and development of the interactive web portal on OXIS classification. The developed website was subjected to user experience testing, functional testing, performance testing, security testing, device, platform testing, and then hosted. Calibrated students and faculties evaluated it with the help of Suitability Assessment of Materials (SAM) and System Usability Scale (SUS). Finally, after amendments, the website was evaluated by non-calibrated researchers and multidisciplinary experts. RESULTS: The total agreement was 74% for overall SAM category. Pooled mean total score of SUS was 52.7 (SD 7.17; range 45-67.5), indicating an average score. CONCLUSION: The content of the developed website has been evaluated as "satisfactory" and its technical quality as "of higher standards".

Assessing methodological quality in dental education research using MERSQI: Analysis of publications from two journals.

PURPOSE: The Medical Education Research Study Quality Instrument (MERSQI) has been used frequently to assess the methodological quality of medical education but not for dental education. The present study aimed to assess the methodological quality using MERSQI scores of articles published in the Journal of Dental Education (JDE) and the European Journal of Dental Education (EJDE). METHODS: A cross-sectional assessment of the quality of manuscripts published in 2012, 2017, and 2022 JDE and EJDE was conducted. MERSQI data, numbers of authors, first and corresponding author degrees, geographic origins, and funding information were also extracted for each included study. Descriptive and analytical statistics were conducted, and significance level was set at α < 0.05. RESULTS: Four hundred ninety-five articles met the inclusion criteria. The most common study design was a single-group cross-sectional or single-group posttest and conducted in one institution for all studied years. In all journals and years, studies were assessed mainly by participants. The study outcome was mostly satisfaction, attitudes, perceptions, opinions, and general facts. The total mean MERSQI score for each journal and year varied. Year and geographic origin significantly affected the total MERSQI score. Papers originating from Asia had the highest score, followed by South America, Europe, North America, Oceania, and Africa. CONCLUSION: MERSQI score is applicable to the assessment of the methodological quality of dental educational research. The MERSQI score for most of the domains was similar for both journals. The MERSQI score was affected by publication years and geographic origins.

Commentary: Challenges and Opportunities for Women in Dental Research.

This commentary integrates and expands on the preceding articles in this issue that document and celebrate a century of women's achievements in the International Association for Dental Research (IADR). The increasing participation and leadership of women in dental and craniofacial research and within the IADR were viewed from the perspective of a changing culture of science. The steps that have been taken by the IADR to develop greater inclusiveness are acknowledged, and some of the challenges that remain are discussed in terms of obstacles that are most often social or cultural in origin. Comparisons are made across countries, and the social determinants that lead to differences in women's participation are described. Recommendations are made for developing strategies to change elements of our institutional cultures that have provided advantages to some groups of researchers more than to others. The unconscious biases and a lack of commitment to diversity, equity, and inclusion that limit the participation of members of some groups limit the progress and achievements of science in general.

Evaluation of dental trials comparing baseline differences using p values.

INTRODUCTION: Significance testing for comparison of the baseline differences between the intervention arms has received a strong condemnation. The goal of this study was to assess the prevalence of randomized controlled trials (RCTs) comparing the baseline characteristics between intervention groups using significance tests in top ten impact factor dental journals. MATERIALS AND METHODS: RCTs published in 10 high impact factor dental journals were searched in PubMed database. Literature search was limited to time duration of 5 years from September 2012 to August 2017. RESULTS: We analysed 521 RCTs after excluding 47 non-RCT articles from the total of 568 articles. Baseline demographic characteristics table was not reported in 45.9% of the RCTs and 26.2% of the RCTs did not report table of baseline clinical characteristics. In 38.9% of the studies, significance testing was employed to compare baseline differences between the intervention arms. CONCLUSIONS: Many trials published in the reputed dental journals failed to follow the recommendations of CONSORT statement regarding reporting of baseline tables and avoiding comparison of baseline differences with significance test.

Statistical testing against baseline in orthodontic research: a meta-epidemiologic study.

BACKGROUND/OBJECTIVES: To assess the prevalence of within-group comparisons from baseline to follow-up in published orthodontic articles and to identify potential associations between this statistical problem and a number of study characteristics. MATERIALS/METHOD: The most recent 24 issues of four leading orthodontic journals with highest impact factor (American Journal of Orthodontics and Dentofacial Orthopedics; AJODO, European Journal of Orthodontics; EJO, Angle Orthodontist; ANGLE, Orthodontics and Craniofacial Research; OCR) were electronically searched until December 31st 2017. The proportion of articles using comparisons against baseline and interpretation of findings according to within-group comparisons were recorded. The association of this practice with journal, year of publication, study design, continent of authorship, number of centres and researchers, statistical significance of results, and statistical analysis was tested. Univariable and multivariable modified Poisson regression were used to identify significant predictors. RESULTS: Overall, 339 articles were eligible for inclusion with the majority published in ANGLE (n = 157, 46%), followed by AJODO (n = 75, 22%), and EJO (n = 75, 22%). A total of 60 studies (18%) presented interpretation of their findings based on within-group comparisons against baseline in isolation. Statistical significance of the primary outcome was a very strong predictor of the prevalence of this flawed approach (RR: 2.33, 95% CIs: 1.22, 4.43; P = 0.01). LIMITATIONS: The effect of time since publication was not addressed. CONCLUSIONS/IMPLICATIONS: Statistical testing and interpretation within groups is prevalent in orthodontic research. Endorsement of accurate conduct and reporting of statistical analyses and interpretation of research findings is important in order to promote optimal inferences to support clinical decision-making.

Quality Assessment of Randomized Clinical Trials Reporting in Endodontic Journals: An Observational Study from 2012 to 2017.

INTRODUCTION: Reports on randomized clinical trials (RCTs) are of critical importance because readers of research often do not access the full text. This study aimed to assess the reporting quality of RCTs in 2 leading endodontic journals. METHODS: Issues of 2 endodontic journals, the Journal of Endodontics and the International Journal of Endodontics, dated from 2012 to 2017 were hand searched to identify RCT reports. A 37-item checklist based on the Consolidated Standards of Reporting Trials statement was used to examine the completeness of RCT reporting. RESULTS: One hundred nine RCT reports were included in this study. The majority were published in the Journal of Endodontics (82%). The mean overall reporting quality score was 65.0% (95% confidence interval, 77.3-66.5). Most (80%-100%) RCTs clearly reported the author/contact details, trial design, participant characteristics, number of participants, and recruitment status as well as the study's intervention(s), objective(s), outcome(s), and conclusions. Conversely, only 56 of the 109 articles (51%) satisfactorily reported all 5 items related to the randomization method. Registration of reviews was not reported in any of the included abstracts. Most of the studies included in this analysis did not report their RCT registration (22%), funding (35%), or protocols (23%). CONCLUSIONS: The results of this study suggest that the reporting quality of RCTs in endodontic journals requires further improvement. Better reporting of RCTs is particularly important for ensuring the reliability of research findings and ultimately promoting the practice of evidence-based dentistry. Optimal RCT reporting should be encouraged, preferably by complying with the Consolidated Standards of Reporting Trials guidelines.

Methodological and Reporting Quality of Systematic Reviews and Meta-analyses in Endodontics.

INTRODUCTION: The aim of this systematic review (SR) was to evaluate the quality of SRs and meta-analyses (MAs) in endodontics. METHODS: A comprehensive literature search was conducted to identify relevant articles in the electronic databases from January 2000 to June 2017. Two reviewers independently assessed the articles for eligibility and data extraction. SRs and MAs on interventional studies with a minimum of 2 therapeutic strategies in endodontics were included in this SR. Methodologic and reporting quality were assessed using A Measurement Tool to Assess Systematic Reviews (AMSTAR) and Preferred Reporting Items for Systematic Review and Meta-Analyses (PRISMA), respectively. The interobserver reliability was calculated using the Cohen kappa statistic. Statistical analysis with the level of significance at P < .05 was performed using Kruskal-Wallis tests and simple linear regression analysis. RESULTS: A total of 30 articles were selected for the current SR. Using AMSTAR, the item related to the scientific quality of studies used in conclusion was adhered by less than 40% of studies. Using PRISMA, 3 items were reported by less than 40% of studies, which were on objectives, protocol registration, and funding. No association was evident comparing the number of authors and country with quality. Statistical significance was observed when quality was compared among journals, with studies published as Cochrane reviews superior to those published in other journals. AMSTAR and PRISMA scores were significantly related. CONCLUSIONS: SRs in endodontics showed variability in both methodologic and reporting quality.

Nyvad Criteria for Caries Lesion Activity and Severity Assessment: A Validated Approach for Clinical Management and Research.

The Nyvad classification is a visual-tactile caries classification system devised to enable the detection of the activity and severity of caries lesions with special focus on low-caries populations. The criteria behind the classification reflect the entire continuum of caries, ranging from clinically sound surfaces through noncavitated and microcavitated caries lesions in enamel, to frank cavitation into the dentin. Lesion activity at each severity stage is discriminated by differences in surface topography and lesion texture. The reliability of the Nyvad criteria is high to excellent when used by trained examiners in the primary and permanent dentitions. The Nyvad criteria have construct validity for lesion activity assessments because of their ability to reflect the well-known caries-controlling effect of fluoride. Predictive validity was demonstrated by showing that active noncavitated lesions are at higher risk of progressing to a cavity or filled state than do inactive noncavitated lesions. Lesion activity assessment performed successfully as a screening tool to identify individuals with a poor caries prognosis. Because of their predictive validity, the Nyvad criteria are superior to other current caries lesion descriptors for the detection of changes in the lesion activity status over time. The Nyvad criteria fulfill all the formal requirements for a robust caries lesion classification and are recommended for evidence-based caries management in clinical practice and in research.

Impact of Selection Bias on Treatment Effect Size Estimates in Randomized Trials of Oral Health Interventions: A Meta-epidemiological Study.

Emerging evidence suggests that design flaws of randomized controlled trials can result in over- or underestimation of the treatment effect size (ES). The objective of this study was to examine associations between treatment ES estimates and adequacy of sequence generation, allocation concealment, and baseline comparability among a sample of oral health randomized controlled trials. For our analysis, we selected all meta-analyses that included a minimum of 5 oral health randomized controlled trials and used continuous outcomes. We extracted data, in duplicate, related to items of selection bias (sequence generation, allocation concealment, and baseline comparability) in the Cochrane Risk of Bias tool. Using a 2-level meta-meta-analytic approach with a random effects model to allow for intra- and inter-meta-analysis heterogeneity, we quantified the impact of selection bias on the magnitude of ES estimates. We identified 64 meta-analyses, including 540 randomized controlled trials analyzing 137,957 patients. Sequence generation was judged to be adequate (at low risk of bias) in 32% ( n = 173) of trials, and baseline comparability was judged to be adequate in 77.8% of trials. Allocation concealment was unclear in the majority of trials ( n = 458, 84.8%). We identified significantly larger treatment ES estimates in trials that had inadequate/unknown sequence generation (difference in ES = 0.13; 95% CI: 0.01 to 0.25) and inadequate/unknown allocation concealment (difference in ES = 0.15; 95% CI: 0.02 to 0.27). In contrast, baseline imbalance (difference in ES = 0.01, 95% CI: -0.09 to 0.12) was not associated with inflated or underestimated ES. In conclusion, treatment ES estimates were 0.13 and 0.15 larger in trials with inadequate/unknown sequence generation and inadequate/unknown allocation concealment, respectively. Therefore, authors of systematic reviews using oral health randomized controlled trials should perform sensitivity analyses based on the adequacy of sequence generation and allocation concealment.

The use of tailored subheadings was successful in enhancing compliance with CONSORT in a dental journal.

OBJECTIVES: Efforts to enhance the reporting of clinical trials have intensified in recent years with automated strategies and editorial involvement showing promise in improving compliance with accepted guidelines. This study aimed to evaluate the effectiveness of a concerted approach to adherence to CONSORT (CONsolidated Standards Of Reporting Trials) guidelines in a dental journal. MATERIALS AND METHODS: Following the publication of an exemplar clinical trial on the American Journal of Orthodontics and Dentofacial Orthopedics (AJO-DO) website and related changes to the author guidelines, trial submissions were required to follow a standard format incorporating subheadings mirroring the CONSORT guidelines. Compliance with CONSORT was assessed in initial submissions over a 30-month period. Reporting was compared to submissions of randomized controlled trials (RCTs) which did not include subheadings over the same period. RESULTS: Seventy-one RCTs were submitted to the AJO-DO from January 2014 to June 2016, 49 with subheadings and 22 without. Most CONSORT items (e.g. random sequence generation, allocation concealment and blinding) were more frequently adequately reported when RCTs were submitted with inclusion of subheadings. Overall, reporting quality of the submitted RCTs was 15.2% higher with use of the subheadings format (95%CI: 10.5, 20.0; p<0.001) with a mean overall score of 87.3%. CONCLUSION: Enhanced compliance of submitted RCTs was found with use of a bespoke approach to trial presentation utilizing CONSORT item subheadings. The improvement in initial submissions is particularly encouraging as this arose without input either from peer reviewers or journal editors. This simple approach may have wider applicability.

Expert panels as a reference standard in orthodontic research: An assessment of published methods and reporting.

INTRODUCTION: The aim of this study was to investigate the expert panel methodology applied in orthodontics and its reporting quality. Additionally, the relationship between the reporting quality and a range of variables was explored. METHODS: PubMed was searched for orthodontic studies in which the final diagnosis or assessment was made by 2 or more experts published up to March 16, 2015. Reporting quality assessment was conducted using an established modified checklist. The relationship between potential predictors and the total score was assessed using univariable linear regression. RESULTS: We identified 237 studies with a mean score of 9.97 (SD, 1.12) out of a maximum of 15. Critical information about panel methodology was missing in all studies. The panel composition differed substantially across studies, ranging from 2 to 646 panel members, with large variations in the expertise represented. Only 17 studies (7.2%) reported sample size calculations to justify the panel size. Panel members were partly blinded in 65 (27.4%) studies. Most studies failed to report which statistic was used to compute intrarater (65.8%) and interrater (66.2%) agreements. Journal type (nonorthodontic: ß, 0.23; 95% CI, -0.07 to 0.54 compared with orthodontic), publication year (ß, 0; 95% CI, -0.02 to 0.02 for each additional year), number of authors (1-3: ß, 0.30; 95% CI, -0.13 to 0.74 compared with at least 6; 4-5: ß, 0.18; 95% CI, -0.29 to 0.33 compared with at least 6), and number of centers involved (single: ß, 0.20; 95% CI, -0.14 to 0.54 compared with multicenter) were not significant predictors of improved reporting. Studies published in Asia and Australia had significantly lower scores compared with those published in Europe (ß, -0.54; 95% CI, -0.92 to -0.17). CONCLUSIONS: Formal guidelines on methodology and reporting of studies involving expert panels are required.

Surveys on Reporting Guideline Usage in Dental Journals.

The objectives of this study were 1) to find out if and how authors and peer reviewers for dental journals are encouraged to use reporting guidelines (RGs); 2) to identify factors related to RG endorsement; and 3) to assess the knowledge, opinions, and future plans of dental journal editors in chief (EICs) on RGs. A total of 109 peer-reviewed and original research-oriented dental journals that were indexed in the MEDLINE and/or SCIE database in 2015 were included. The "instructions to authors" and "instructions to reviewers" of these journals were identified and retrieved from journals' official websites. Any mention of RGs or other related policies were sought and extracted. In addition, an anonymous survey of the EICs of the included journals was conducted with a validated questionnaire. All 109 journals provided "instructions to authors," among which 55 (50.5%) mentioned RGs. Only the CONSORT (45.0%), PRISMA (13.8%), and STROBE (12.8%) guidelines were mentioned by >10% of the included journals. Statistical analyses suggest that RGs were more frequently mentioned by SCIE-indexed journals (P < 0.001), higher-impact journals (P = 0.002), and journals that endorsed the ICMJE recommendations (P < 0.001). "Instructions to reviewers" were available online for only 9 journals (8.3%), 3 of which mentioned RGs. For the EIC survey, the response rate was 32.1% (35 of 109). Twenty-six editors (74.3%) stated that they knew what RGs were before receiving our questionnaire. Twenty-four editors (68.6%) believed that RGs should be adopted by all refereed dental journals where appropriate. RGs are important tools for enhancing research reporting and reducing avoidable research waste, but currently they are not widely endorsed by dental journals. Joint efforts by all stakeholders to further promote RG usage in dentistry are needed.