Review of patient-reported outcomes (PROs) and non-PROs in randomized controlled trials addressing head/neck cancers.

BACKGROUND: To assess the frequency of patient-reported outcomes (PROs) and non-PROs in randomized controlled trials (RCTs) addressing head/neck cancers. METHODS: We included RCTs about interventions to treat head/neck cancers. PubMed was searched on September 16, 2022 and included studies published during three periods (2000-2002, 2010-2012, and 2020-2022). Data on types of outcomes and instruments to measure them were extracted and organized into PROs and non-PROs, and temporal trends for reporting outcomes were determined. RESULTS: There was a reduction in the frequency of non-PROs (40% to 22%) and an increase in PROs (5% to 19%) over 20 years. The frequency of reporting both non-PROs and PROs seemed to be stable over the same period (55% to 58%). A great variety of instruments to measure PROs and non-PROs was identified. CONCLUSIONS: There has been a growth in the types of PROs in more recent years, and they were more frequently reported in RCTs. However, head/neck cancer trials with a combination of PROs and non-PROs were the most prevalent.

Reducing the residue of retractions in evidence synthesis: ways to minimise inappropriate citation and use of retracted data.

The incorporation of publications that have been retracted is a risk in reliable evidence synthesis. Retraction is an important mechanism for correcting the literature and protecting its integrity. Within the medical literature, the continued citation of retracted publications occurs for a variety of reasons. Recent evidence suggests that systematic reviews and meta-analyses often unwittingly cite retracted publications which, at least in some cases, may significantly impact quantitative effect estimates in meta-analyses. There is strong evidence that authors of systematic reviews and meta-analyses may be unaware of the retracted status of publications and treat them as if they are not retracted. These problems are difficult to address for several reasons: identifying retracted publications is important but logistically challenging; publications may be retracted while a review is in preparation or in press and problems with a publication may also be discovered after the evidence synthesis is published. We propose a set of concrete actions that stakeholders (eg, scientists, peer-reviewers, journal editors) might take in the near-term, and that research funders, citation management systems, and databases and search engines might take in the longer term to limit the impact of retracted primary studies on evidence syntheses.

Overview of systematic reviews on periodontal-orthodontic interactions: A comprehensive literature analysis.

The aims of this research were to investigate the methodological quality of systematic reviews on periodontal-orthodontic interactions (i.e. reviews of primary research broadly defined as any including both periodontic and orthodontic components) and to provide a mapping of the researched topics. We searched four major databases (PubMed, Lilacs, Web of Science, and Embase) for systematic reviews of periodontal-orthodontic interactions. We used the AMSTAR-2 tool (the acronym is derived from 'a measurement tool to assess systematic reviews') to assess the methodological quality of the included systematic reviews. Individual AMSTAR-2 ratings were tabulated, and the percentage per item was calculated. To assess the association between the AMSTAR-2 percentage score and the overall confidence in the systematic review results, an ordinal regression model was used. We initially retrieved 973 documents, and 43 systematic reviews were included. Systematic reviews of interventions were the most prevalent (n = 26, 60.5%). Most of the systematic reviews did not report a meta-analysis (n = 25, 58.1%). In addition, most of the studies included in the systematic reviews had an unclear or high risk of bias. Most of the systematic reviews were rated as having critically low or low overall confidence (n = 34, 79.1%). A significant correlation was found between the AMSTAR-2 percentage score and overall confidence in the results. The methodological quality of systematic reviews on periodontal-orthodontic interactions can be improved. The limitations of our study include potential language bias and an arbitrary classification of the topics researched.

A case study evaluating the effect of clustering, publication bias, and heterogeneity on the meta-analysis estimates in implant dentistry.

Meta-analyses may provide imprecise estimates when important meta-analysis parameters are not considered during the synthesis. The aim of this case study was to highlight the influence of meta-analysis parameters that can affect reported estimates using as an example pre-existing meta-analyses on the association between implant survival and sinus membrane perforation. PubMed was searched on 7 July 2021 for meta-analyses comparing implant failure in perforated and non-perforated sinus membranes. Primary studies identified in these meta-analyses were combined in a new random-effects model with odds ratios (ORs), confidence intervals (CIs), and prediction intervals reported. Using this new meta-analysis, further meta-analyses were then undertaken considering the clinical, methodological, and statistical heterogeneity of the primary studies, publication bias, and clustering effects. The meta-analyses with the greatest number and more homogeneous studies provided lower odds of implant failure in non-perforated sites (OR 0.49, 95 % CI = [0.26, 0.92]). However, when considering heterogeneity, publication bias, and clustering (number of implants), the confidence in these results was reduced. Interpretation of estimates reported in systematic reviews can vary depending on the assumptions made in the meta-analysis. Users of these analyses need to carefully consider the impact of heterogeneity, publication bias, and clustering, which can affect the size, direction, and interpretation of the reported estimates.

Education and learning: potential methodological and ethical issues in systematic reviews containing a meta-analysis: some critical reading suggestions for junior doctors.

Junior doctors make clinical decisions regularly; therefore, they need to adequately interpret the evidence supporting these decisions. Patients can be harmed if clinical treatments are supported by biased or unreliable evidence. Systematic reviews that contain meta-analyses of randomized controlled trials are a relatively low-biased type of evidence to support clinical interventions. Therefore, it is reasonable to think that doctors will likely select this type of study to answer clinical questions. In this article, doctors are informed about potential methodological and ethical issues in systematic reviews that contain a meta-analysis that are sometimes not easily identified or even overlooked by the current tools developed to assess their methodological quality or risk of bias. The article presents a discussion of topics related to data extraction, accuracy in reporting, reproducibility, heterogeneity, quality assessment of primary studies included in the systematic review, sponsorship, and conflict of interest. It is expected that the information reported will be useful for junior doctors when they are reading and interpreting evidence from systematic reviews containing meta-analyses of therapeutic interventions, mainly those doctors unfamiliar with methodological principles.

The need for clear criteria for the selection of participants in scientific workshops.

Scientific workshops are held to develop important documents for clinical practice and policymaking. In these workshops, people with different skills and backgrounds meet to discuss, plan and conduct the development of systematic reviews and clinical guidelines that will be references for researchers, clinicians, patients and other stakeholders, such as insurance companies. The aim of this opinion article is to initiate a discussion on the need for clear and measurable criteria for the selection of participants in scientific workshops. Some examples of workshops in different dental disciplines are used to illustrate that apparently there is no transparent reporting of the criteria used to select participants. Some ethical implications are described in this article, as well as some suggestions to increase transparency in the process of selecting the participants for these scientific workshops. It is expected that overall trust in research, including from parties not directly associated with it, will increase when these selection criteria are transparently reported.

Effect of nanofibers as reinforcement on resin-based dental materials: A systematic review of in vitro studies.

This systematic review provides an update on the effect of nanofibers as reinforcement on resin-based dental materials. A bibliographic search was conducted in MEDLINEPubMed, Embase, Web of Science, Scopus, BVS (LILACS, BBO e IBECS), Cochrane, LIVIVO, and gray literature (BDTD) to identify relevant articles up to May 2021. In vitro studies that evaluated and compared the mechanical properties of nanofibers resin-based composite materials, were eligible. No publication year or language restriction was applied, and methodological quality was assessed using two methods. In a total of 6100 potentially eligible studies, 81 were selected for full-text analysis and 35 were included for qualitative analysis. Of the 35 included studies, a total of 29 studies evaluated the flexural strength (FS) of the materials. These groups were distinguished according to the resin-based materials tested and nanofiber types. Most of the studies evaluated materials composed of glass fibers and demonstrated higher values of FS when compared to resin-based materials without nanofibers. The incorporation of nanofibers into resin-based dental materials improved the mechanical properties compared to resin-based materials without nanofibers, suggesting better performance of these materials in high-stressbearing application areas. Further clinical studies are required to confirm the efficacy of resin-based materials with nanofibers.

Reporting of flow diagrams in randomised controlled trials published in periodontology and implantology: a survey.

BACKGROUND: Item 13 of the CONSORT guidelines recommends documentation of the participant flow in randomised clinical trials (RCTs) using a diagram. In the medical literature, the reporting of the flow of participants in RCTs has been assessed to be inadequate. The quality of reporting flow diagrams in periodontology and implantology remains unknown. The aim of this study was to assess the reporting of flow diagrams in RCTs published in periodontology and implantology journals. MATERIALS AND METHODS: RCTs published between 15th January 2018 and 15th January 2022 in twelve high-ranked periodontology and implantology journals were identified. Trial characteristics at the RCT level were extracted. The flow diagram included in each RCT was assessed for completeness of reporting in relation to published criteria and the CONSORT flow diagram template. RESULTS: From the 544 eligible articles, 85% were single-centre, 82% of parallel-group design and 79% investigated surgical interventions. Three-hundred and fifteen (58%) articles were published in CONSORT endorsing journals. A flow diagram was reported in 317 (58%) trials and reporting was more common in periodontology (73.1%). Overall, 56% of publications with a flow diagram reported a complete CONSORT flow diagram, while in 44% of flow diagrams, at least one point from the CONSORT reporting template was missing. Reasons for loss to follow-up (69.7%) and exclusions from the RCT analysis (86.4%) were poorly reported. CONCLUSION: The reporting of flow diagrams in periodontology and implantology RCTs was sub-optimal. Greater awareness of the importance of fully completing the participant CONSORT flow diagram is required.

ASSESSMENT OF THE FREQUENCY OF REPORTING DENTAL PATIENT-REPORTED OUTCOMES (dPROs) IN A SAMPLE OF RANDOMIZED CONTROLLED TRIALS ON ROOT COVERAGE PROCEDURES.

OBJECTIVE: Dental patient-reported outcomes (dPROs) are important for understanding the impact of proposed therapies on patients' oral health. The aims of the present study were to investigate the frequency of the reporting of dPROs in randomized controlled trials (RCTs) of root coverage procedures and to assess associations between the study/article characteristics and the reporting level of the dPROs. METHODS: The PubMed database was searched for RCTs of root coverage procedures in March 16, 2022 and articles published up to March 2022 were included. Information on the types of outcomes and the characteristics of the studies/articles were extracted and reported as frequencies and percentages. Univariate and multivariate binary logistic regression analyses were performed to investigate the associations between the study/article characteristics and the reporting level of dPROs. RESULTS: The search initially identified 387 articles, and after applying the eligibility criteria, 135 articles reporting 135 RCTs were included. A combination of dPROs and non-dPROs was reported in 61.5% of the selected trials, while 37.8% of the trials reported only non-dPROs. Pain or discomfort was the most frequently reported dPRO (n = 58, 43% of the RCTs). More recently published RCTs reported more dPROs. The country of the first author (odds ratio [OR]: 4.39; 95% CI: 1.76-10.95; P < .01), protocol registration (OR: 0.36; 95% CI: 0.16-0.83; P = .02), and RCT type (OR: 0.38; 95% CI: 0.17-0.83; P = .02) were significantly associated with the reporting level of the dPROs. CONCLUSIONS: Researchers in recent years seem to be paying more attention to the importance of dPROs. RCTs in which the first authors were from developed countries, registered trials, and RCTs with a parallel design were more likely to report dPROs than RCTs with first authors from developing countries, unregistered trials, and RCTs with a split-mouth design.

A comprehensive overview of studies that assessed article retractions within the biomedical sciences.

This study aims to provide a comprehensive overview of previous research that has investigated retractions within the biomedical fields and assess their methodological quality. We searched three major electronic databases for articles on retractions within the biomedical field: PubMed, Web of Science, and Scopus. In total, 162 articles were included in the analysis. We evaluated their methodological quality using the items of "a measurement tool to assess systematic reviews" (AMSTAR-2) checklist and the Cochrane guidance. The studies had been published in more than 20 biomedical disciplines or fields of investigation, and two-thirds were published after 2017. Concerning methodology, none of the studies fulfilled all the suggested items; five studies did not meet any of the suggested AMSTAR-2 categories or Cochrane guidelines. The most prevalent reported reasons for retraction were fraud and plagiarism (21.0%). In summary, there has been increasing interest in assessing the characteristics and impact of retractions in the biomedical sciences. The studies cited types of misconduct more often than honest errors as a major reason for retraction. The methodological quality of the existing studies in this area appears to be suboptimal. Future investigators should improve upon this, particularly in the quality of the data selection and extraction.

Are highly ranked dental journals at risk of editorial bias? An examination of information on the reporting of peer-review practices.

The objective of the present study was to assess how clearly and transparently reported are the editorial policies of highly ranked dental journals regarding the handling of submitted manuscripts. A total of 92 dental journals classified by impact factor had their websites scrutinized between 22 July and 6 September 2021 for all information on their policies regarding the handling of submitted manuscripts by editors. The information included items that could indicate potential risk of editorial bias. A total of 49 (53.3%) of the selected journals allowed the submission of all types of manuscripts, while 26 (28.3%) journals did not allow some types of manuscripts to be submitted (some manuscripts are only commissioned). The criteria for the acceptance of submitted manuscripts were clearly reported in eight (8.7%) journals, and only one reported the criteria in a hierarchical fashion. Sixteen (17.4%) journals reported a policy for handling the submitted manuscript when an editor was the author of the manuscript. Nine (9.8%) journals reported the possibility of a rebuttal letter by authors after manuscript rejection, but for most (62%) journals this information was not reported. The reporting of editorial policies regarding the peer-review process in highly ranked dental journals should be improved.

Should informed consent and information related to patient recruitment in clinical trials be available to the reader of scientific articles? A case study in dentistry.

Ethical aspects in research should be transparently reported. This study aimed to investigate whether informed consent and information related to patient recruitment in clinical studies are well reported in the scientific literature. Randomized clinical trials (RCTs) on root coverage procedures published between November 2016 and November 2021 were selected from the PubMed database. Items/questions were used to guide the extraction of data related to patient recruitment, with a focus on the detailed report of informed consent used to clarify the research to the patient. Data were extracted from the published article and the respective research protocol published in a public registry. Information related to potential selective outcome reporting (SOR) was also extracted. In total, 187 documents were initially screened and 74 reports of RCTs were included. No informed consent was published in the article. Only one research protocol provided a link to the informed consent. Deviations from reporting in the research protocol and published article were found, suggesting SOR. Informed consent and information related to patient recruitment in RCTs on root covering procedures are severely underreported. The present findings may stimulate further discussion and debate on the need for making this information publicly available.

COMBINATION OF Nd:YAG AND Er:YAG LASERS MIGHT IMPROVE PERIODONTAL PROBING DEPTHS AND CLINICAL ATTACHMENT LEVELS, BUT THE LEVEL OF EVIDENCE IS VERY WEAK.

ARTICLE TITLE AND BIBLIOGRAPHIC INFORMATION: Estrin NE, Moraschini V, Zhang Y, Romanos GE, Sculean A, Miron RJ. Combination of Nd:YAG and Er:YAG lasers in non-surgical periodontal therapy: a systematic review of randomized clinical studies. Lasers Med Sci. 2022 Apr 1. doi: 10.1007/s10103-022-03548-6. Epub ahead of print. PMID: 35364744. SOURCE OF FUNDING: There was no statement on the source of funding. TYPE OF STUDY/DESIGN: Systematic review with meta-analysis.

The Reporting Quality of Split-Mouth Studies in Implant Dentistry: A Survey.

PURPOSE: The results of trials can inform health care decisions. However, this is dependent on both clear and transparent reporting. The aim of this study was to assess the reporting quality of split-mouth trials in implant dentistry in relation to the CONSORT extension checklist for reporting within-person randomized clinical trials (RCTs). MATERIALS AND METHODS: Split-mouth trials published between January 1, 1997, and September 30, 2020, were identified from four databases. Study characteristics at the level of each trial were extracted. Each trial was assessed against a 37-item checklist and assigned one of four categories. Descriptive statistics and the frequencies of the ratings per checklist item were calculated. A percentage score was calculated per study. Linear regression assessed associations between the aggregate score and the study characteristics. RESULTS: Two hundred forty-four trials were analyzed. More than 50% of the RCTs were published between 2016 and 2020, were published in specialty journals (81.2%), and were interventional-type RCTs (98.4%). Generally, the reporting of checklist items was suboptimal in many areas. The reporting score was predicated by the number of authors (> 7 vs baseline [1 to 4] authors: ß: 6.00; 1.48, 10.52; P = .01), authors' continent (Europe vs Americas: ß: 5.30; 0.85, 9.74; P = .02), and the number of participants (per-unit increase: ß: .07; 0.01, 0.12; P = .02). CONCLUSION: The reporting of split-mouth trials in implant dentistry seems to be suboptimal. The endorsement and adherence to the CONSORT extension for the within-person trials checklist by journal editors and investigators could improve reporting quality and transparency.

Methodological assessment of systematic reviews of in-vitro dental studies.

BACKGROUND: Systematic reviews of in-vitro studies, like any other study, can be of heterogeneous quality. The present study aimed to evaluate the methodological quality of systematic reviews of in-vitro dental studies. METHODS: We searched for systematic reviews of in-vitro dental studies in PubMed, Web of Science, and Scopus databases published up to January 2022. We assessed the methodological quality of the systematic reviews using a modified "A MeaSurement Tool to Assess systematic Reviews" (AMSTAR-2) instrument. The 16 items, in the form of questions, were answered with yes, no, or py (partial yes). Univariable and multivariable linear regression models were used to examine the association between systematic review characteristics and AMSTAR-2 percent score. Overall confidence in the results of the systematic reviews was rated, based on weaknesses identified in critical and non-critical AMSTAR-2 items. RESULTS: The search retrieved 908 potential documents, and after following the eligibility criteria, 185 systematic reviews were included. The most researched topics were ceramics and dental bonding. The overall rating for the confidence in the results was critically low in 126 (68%) systematic reviews. There was high variability in the response among the AMSTAR-2 items (0% to 75% positively answered). The univariable analyses indicated dental specialty (p = 0.03), number of authors (coef: 1.87, 95% CI: 0.26, 3.47, p = 0.02), and year of publication (coef: 2.64, 95% CI: 1.90, 3.38, p < 0.01) were significantly associated with the AMSTAR-2 percent score. Whereas, in the multivariable analysis only specialty (p = 0.01) and year of publication (coef: 2.60, 95% CI: 1.84, 3.35, p < 0.001) remained significant. Among specialties, endodontics achieved the highest AMSTAR-2 percent score. CONCLUSIONS: The methods of systematic reviews of in vitro dental studies were suboptimal. Year of publication and dental specialty were associated with AMSTAR-2 scores. The overall rating of the confidence in the results was low and critically low for most systematic reviews.