Protocol of investigation into reporting quality of RCT abstracts on COVID-19 pursuant to CONSORT (CoCo study)—a review

Background!#!In 2020, the COVID-19 pandemic developed into a global crisis, the enormity and urgency of which accelerated research activities in the field. At the same time, manuscripts describing these research projects underwent fast-track peer review procedures and were published in freely accessible formats. Although full texts about COVID-19 are currently available for free, abstracts continue to play a key role since they provide essential information and possibly a decision basis for therapies. Abstracts are particularly important in case the full texts are not free, not all reports have been published in English and in emergency situations when there is less time for comprehensive analysis of all full texts. It is therefore necessary to ensure that abstracts-as publications in miniature format-contain comprehensive and transparent information. The CONSORT statement for abstracts (CONSORT-A) offers guidelines to authors how to include all necessary information in an abstract. Prior to the COVID-19 pandemic, the quality of reporting in medical research had already been the object of debate and criticism. The current crisis makes comprehensive documentation all the more important. Abstracts of COVID-19 RCTs should therefore report the criteria listed in the CONSORT-A statement fully and verifiably. The objective of this study is to check the completeness of abstracts of all COVID-19 RTCs published to date.!##!Methods!#!Based on a literature search in PubMed, Embase and the Cochrane Library, all publications up to 29 October 2020 are identified and examined in terms of the subject matter (reported results from COVID-19 studies) and their study design (RTC). Subsequently, suitable publications are examined for completeness and quality of abstracts. The CONSORT checklist for RTC abstracts serves as a basis in this procedure. The primary endpoint of the study is the percentage of correctly implemented items of the CONSORT statement for abstracts. The frequency of correct reporting of each individual item is checked in a second step.!##!Discussion!#!The study is expected to contribute to evaluating the reporting quality on COVID-19 studies, and specifically the completeness of abstracts of RTCs. It may thus support the assessment of current research into COVID-19.!##!Trial registration!#!Registration was not required as the study investigated existing literature

Reporting of statistical sample size calculations in publications of trials on age-related macular degeneration, glaucoma and cataract.

BackgroundTransparent and complete publications of randomised controlled trials (RCT) ought to comply with the guidelines of the CONSORT Statement, which stipulates sample size calculation as an important aspect of trial planning. The objective of this study was to analyse and compare the reporting of statistical sample size calculations in RCT papers on the treatment of age-related macular degeneration (AMD), glaucoma and cataract published in 2018.Material and methodsThis study comprises a total of 113 RCT papers (RCT-P) published in 2018 (AMD: 14, glaucoma: 28, cataract: 71), in English or German, and identified through an internet-based literature search in PubMed and EMBASE. The primary outcome measure of the study was the number of trials providing a complete description of the underlying sample case calculation on the basis of the variables required (significance level, expected outcomes, power, and resulting sample size).ResultsOf the RCTs reviewed, 64% (AMD), 61% (glaucoma) and 31% (cataract) provided a justification of the number of patients included. A complete description of the described studies' sample size calculation including all the necessary values (primary outcome measure of this study) was described by 21% of the AMD, 29% of the cataract and 18% of the glaucoma RCT publications (in total: 24 of 113 (21%) at a confidence interval of 95%: [13%; 29%]).ConclusionAll three treatment areas analysed lacked reporting quality regarding the justification of the number of patients included in a clinical trial based on a sample size calculation required for ethical reasons. More than half of all RCT publications reviewed did not provide all of the required information on statistical sample size calculation, and thus lacked transparency and completeness. It is therefore urgently required to involve methodologists in a study's planning and publishing processes to ensure that methodology descriptions are transparent and of high quality

Prevalence of Oral and Maxillofacial Disorders in Patients with Systemic Scleroderma-A Systematic Review

Background: Systematic scleroderma is a rare chronic autoimmune disease of unknown aetiology. The aim of this study was to identify the prevalence of orofacial pathognomonic conditions in patients with systemic scleroderma using only randomised prospective studies that investigated the treatment of oral and maxillofacial changes, highlighted associations between the disease and Sjogren's syndrome, and/or analysed the effect of oral hygiene. Methods: The literature was systematically reviewed based on Cochrane Library, EMBASE, PubMed, Scopus, and Web of Science articles published up to March 2020. The primary endpoint of this analysis was defined as an estimation of the prevalence of oral mucosal changes in different areas of the oral cavity (oral mucosa, tongue, lip, periodontal status, bones, and other regions) in patients suffering from scleroderma. Therefore, a systematic literature search (Cochrane Library, EMBASE, PubMed, Scopus, and Web of Science) was conducted and limited by the publication date (1950-03/2020) and the publication language (English). Extracted frequencies were pooled using methods for meta-analysis. In order to obtain the highest level of evidence, only prospective study reports were considered to be eligible. Results: After full-text screening, 14 (766 patients) out of 193 publications were eligible for the final analysis. Twelve studies produced reliable results in the final data sets. Calculation of the pooled effect estimate (random effects model) revealed a prevalence of 57.6% (95% CI: 40.8-72.9%) for the main area lip. For the area oral mucosa, a prevalence of 35.5% (95% CI: 15.7-62.0%) was calculated. The prevalence for other regions was only based on studies with salivary changes and was calculated to be 25.4% (95% CI: 14.2-41.3%). Conclusion: The most pathognomonic conditions in the orofacial region in patients with systemic scleroderma affect the lips, oral mucosa, and salivary glands

Influence of Luting Materials on the Retention of Cemented Implant-Supported Crowns: An In Vitro Study

The retention force of cemented crowns on implant abutments with various luting materials was evaluated. Cobalt–chromium crowns were cemented onto tapered titanium abutments (Camlog) with eugenol-free temporary cement (RelyX TempBond NE), composite-based temporary cement (Bifix Temp), zinc phosphate cement (Harvard Cement), glass-ionomer cements (Meron, Fuji I), and resin-modified glass-ionomer cements (Fuji II, Fuji Plus, Ketac Cem Plus). Specimen aging via hydrostress was performed in artificial saliva at 37 °C for 14 days (S1), followed by hydrothermal stress with thermocycling (S2). The crowns were removed, and the force was recorded (T1). Subsequently, the crowns were recemented, aged, and removed, and the force was recorded (T2, T3). The retention forces differences were statistically significant according to the storage conditions at T1 (p = 0.002) and T3 (p = 0.0002). After aging (S1), Ketac Cem Plus had the highest retention force median value difference (T3 versus T1) (−773 N), whereas RelyX TempBond NE had the lowest (−146 N). After aging (S2), Meron had the highest retention force median value difference (−783 N), whereas RelyX TempBond NE had the lowest (−168 N). Recementation decreased the retention force of the implant-supported cobalt–chromium crowns cemented and recemented with the same luting materials. Luting materials (at T1) and aging conditions significantly impacted the retention force