Development of the CDISC Pediatrics User Guide: a CDISC and conect4children collaboration.

Introduction: The conect4children (c4c) project aims to facilitate efficient planning and delivery of paediatric clinical trials. One objective of c4c is data standardization and reuse. Interoperability and reusability of paediatric clinical trial data is challenging due to a lack of standardization. The Clinical Data Interchange Standards Consortium (CDISC) standards that are required or recommended for regulatory submissions in several countries lack paediatric specificity with limited awareness within academic institutions. To address this, c4c and CDISC collaborated to develop the Pediatrics User Guide (PUG) consisting of cross-cutting data items that are routinely collected in paediatric clinical trials, factoring in all paediatric age ranges. Methods and Results: The development of the PUG consisted of six stages. During the scoping phase, subtopics (each containing several clinically relevant concepts) were suggested and debated for inclusion in the PUG. Ninety concepts were selected for the modelling phase. Concept maps describing the Research Topic and representation procedure were developed for the 19 concepts that had no (or partial) previous modelling in CDISC. Next, metadata and implementation examples were developed for concepts. This was followed by a CDISC internal review and a public review. For both these review stages, the feedback comments were either implemented or rejected based on budget, timelines, expert review, and scope. The PUG was published on the CDISC website on February 23, 2023. Discussion: The PUG is a first step in bridging the lack of child specific CDISC standards, particularly within academia. Several academic and industrial partners were involved in the development of the PUG, and c4c has undertaken multiple steps to publicize the PUG within its academic partner organizations - in particular, the European Reference Networks (ERNs) that are developing registries and dictionaries in 24 disease areas. In the long term, continued use of the PUG in paediatric clinical trials will enable the pooling of data from multiple trials, which is particularly important for medical domains with small populations.

Non-Inferiority Trials: A Systematic Review on Methodological Quality and Reporting Standards.

BACKGROUND: Non-inferiority (NI) trials require unique trial design and methods, which pose challenges in their interpretation and applicability, risking introduction of inferior therapies in clinical practice. With the abundance of novel therapies, NI trials are increasing in publication. Prior studies found inadequate quality of reporting of NI studies, but were limited to certain specialties/journals, lacked NI margin evaluation, and did not examine temporal changes in quality. We conducted a systematic review without restriction to journal type, journal impact factor, disease state or intervention to evaluate the quality of NI trials, including a comprehensive risk of bias assessment and comparison of quality over time. METHODOLOGY: We searched PubMed and Cochrane Library databases for NI trials published in English in 2014 and 2019. They were assessed for: study design and NI margin characteristics, primary results, and risk of bias for blinding, concealment, analysis method and missing outcome data. RESULTS: We included 823 studies. Between 2014 and 2019, a shift from publication in specialty to general journals (15% vs 28%, p < 0.001) and from pharmacological to non-pharmacological interventions (25% vs 38%, p = 0.025) was observed. The NI margin was specified in most trials for both years (94% vs 95%). Rationale for the NI margin increased (36% vs 57%, p < 0.001), but remained low, with clinical judgement the most common rationale (30% vs 23%), but more 2019 articles incorporating patient values (0.3% vs 21%, p < 0.001). Over 50% of studies were open-label for both years. Gold standard method of analyses (both per protocol + (modified) intention to treat) declined over time (43% vs 36%, p < 0.001). DISCUSSION: The methodological quality and reporting of NI trials remains inadequate although improving in some areas. Improved methods for NI margin justification, blinding, and analysis method are warranted to facilitate clinical decision-making.

The 300 Marines: characterizing the US Marines with perfect scores on their physical and combat fitness tests.

Few US Marines earn perfect 300 scores on both their Physical Fitness Test (PFT) and Combat Fitness Test (CFT). The number 300 invokes the legendary 300 Spartans that fought at the Battle of Thermopylae, which inspired high physical fitness capabilities for elite ground forces ever since. Purpose: Determine distinguishing characteristics of the "300 Marines" (perfect PFT and CFT scores) that may provide insights into the physical and physiological requirements associated with this capability. These tests have been refined over time to reflect physical capabilities associated with Marine Corps basic rifleman performance. Materials and methods: Data were analyzed from US Marines, including 497 women (age, 29 ± 7 years; height 1.63 ± 0.07 m; body mass, 67.4 ± 8.4 kg) and 1,224 men (30 ± 8 years; 1.77 ± 0.07 m; 86.1 ± 11.1 kg). Marines were grouped by whether they earned perfect 300 scores on both the PFT and CFT (300 Marines) or not. We analyzed group differences in individual fitness test events and body composition (dual-energy x-ray absorptiometry). Results: Only 2.5% (n = 43) of this sample earned perfect PFT and CFT scores (n = 21 women; n = 22 men). Compared to sex-matched peers, 300 Marines performed more pull-ups, with faster three-mile run, maneuver-under-fire, and movement-to-contact times (each p < 0.001); 300 Marines of both sexes had lower fat mass, body mass index, and percent body fat (each p < 0.001). The lower percent body fat was explained by greater lean mass (p = 0.041) but similar body mass (p = 0.085) in women, whereas men had similar lean mass (p = 0.618), but lower total body mass (p = 0.025). Conclusion: Marines earning perfect PFT and CFT scores are most distinguished from their peers by their maneuverability, suggesting speed and agility capabilities. While both sexes had considerably lower percent body fat than their peers, 300 Marine women were relatively more muscular while men were lighter.

Current status and future of genomics in fetal and maternal medicine: A scientific review commissioned by European Board and College of Obstetrics and Gynaecology (EBCOG).

This EBCOG guidance reviews the current and future status of genomics within fetal and maternal medicine. This document addresses the clinical uses of genetic testing in both screening and diagnostic testing prenatally. The role of genomics within fetal and maternal medicine is described. The research and future implications of genetic testing as well as the educational, ethical and economic implications of genomics are discussed.

Characterization of Prototype Gummy Formulations Provides Insight into Setting Quality Standards.

Gummy formulations are considered suitable alternatives to traditional oral dosage forms like tablets and capsules due to their merits that include chewability, softness/flexibility, improved drug release, administration without water, appealing organoleptic properties, better patient compliance, easy preparation and usefulness for persons of different ages (e.g. children). Though there is increasing interest in gummy formulations containing drugs, measurable parameters, and specification limits for evaluating their quality are scarce. Quality check forms an essential part of the pharmaceutical development process because drug products must be distributed as consistently stable, safe, and therapeutically effective entities. Consequently, some quality parameters that could contribute to the overall performance of typical gummy formulations were investigated employing six brands of non-medicinal gummies as specimens. Accordingly, key physicochemical and micromechanical characteristics namely adhesiveness (0.009 - 0.028 mJ), adhesive force (0.009 - 0.055 N), chewiness (2.780 - 6.753 N), cohesiveness (0.910 - 0.990), hardness (2.984 - 7.453 N), springiness (0.960 - 1.000), and resilience (0.388 - 0.572), matrix firmness - compression load (2.653 - 6.753 N) and work done (3.288 - 6.829 mJ), rupture (5.315 - 29.016 N), moisture content (< 5%), weight uniformity (< 2.5 g; < 7.5% deviation), and intraoral dissolution pH (≥ 3.5 ≤ 6.8) were quantified to identify measures that may potentially function as specification limits and serve as prospective reference points for evaluating the quality of gummy formulations. Findings from this work contribute to ongoing efforts to standardize the quality control strategies for gummy formulations, particularly those intended for oral drug delivery.

Review of the Australian nurse teacher professional practice standards: An e-Delphi study.

AIM: The aim of the study was to review the 2010 Australian nurse teacher professional practice standards ('the Standards') to see if they were still relevant to current nursing educator practice in any practice setting, such as academia or clinical settings. BACKGROUND: It has been over 10 years since 'the Standards have been reviewed. Nurse education practice has met many challenges in the past decade, so it is timely to evaluate whether the Standards are still relevant to nursing educators today. DESIGN: A modified Delphi technique was used for this study. METHODS: Delphi surveys were used to obtain consensus on the relevance of the Standards' statements to any nursing educator. Links to two electronic surveys were sent to an expert panel of nursing educator leaders. Also, two online focus groups of nursing educators from any practice setting or level of experience were held. Results from the first survey and focus groups led to word changes and additional statements, which were included in the second Delphi survey. RESULTS: Forty participants responded to the first survey and 38 to the second. Fifteen nursing educators attended the focus groups. There was ≥85 % agreement on all statements in the first survey. with similar high agreement responses in the second survey. Changes in the Standards included language used around culture, inclusion of 'sustainability of the program' and 'demonstrates knowledge and expertise in teaching and educational practice'. CONCLUSIONS: The Australian nurse teacher professional practice standards remain highly relevant to nursing educators across all practice settings. In response to feedback from nursing educators some changes to language and additional standard statements were included in the revised standards.

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.

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.

mzIdentML 1.3.0 - Essential progress on the support of crosslinking and other identifications based on multiple spectra.

The mzIdentML data format, originally developed by the Proteomics Standards Initiative in 2011, is the open XML data standard for peptide and protein identification results coming from mass spectrometry. We present mzIdentML version 1.3.0, which introduces new functionality and support for additional use cases. First of all, a new mechanism for encoding identifications based on multiple spectra has been introduced. Furthermore, the main mzIdentML specification document can now be supplemented by extension documents which provide further guidance for encoding specific use cases for different proteomics subfields. One extension document has been added, covering additional use cases for the encoding of crosslinked peptide identifications. The ability to add extension documents facilitates keeping the mzIdentML standard up to date with advances in the proteomics field, without having to change the main specification document. The crosslinking extension document provides further explanation of the crosslinking use cases already supported in mzIdentML version 1.2.0, and provides support for encoding additional scenarios that are critical to reflect developments in the crosslinking field and facilitate its integration in structural biology. These are: (i) support for cleavable crosslinkers, (ii) support for internally linked peptides, (iii) support for noncovalently associated peptides, and (iv) improved support for encoding scores and the corresponding thresholds.

A knowledge synthesis of health research reporting standards relevant to epilepsy surgery.

OBJECTIVE: Numerous studies have examined epilepsy surgery outcomes, yet the variability in the level of detail reported hampers our ability to apply these findings broadly across patient groups. Established reporting standards in other clinical research fields enhance the quality and generalizability of results, ensuring that the insights gained from studying these surgeries can benefit future patients effectively. This study aims to assess current reporting standards for epilepsy surgery research and identify potential gaps and areas for enhancement. METHODS: The Enhancing the Quality and Transparency of Health Research (EQUATOR) repository was accessed from inception to April 27, 2023, yielding 561 available reporting standards. Reporting standards were manually reviewed in duplicate independently for applicability to epilepsy and/or neurosurgery research. The reporting standards had to cover the following aspects in human studies: (1) reporting standards for epilepsy/epilepsy surgery and (2) reporting standards for neurosurgery. Disagreements were resolved by a third author. The top five neurosurgery, neurology, and medicine journals were also identified through Google Scholar's citation index and examined to determine the relevant reporting standards they recommended and whether those were registered with EQUATOR. RESULTS: Of the 561 EQUATOR reporting standards, 181 were pertinent to epilepsy surgery. One was related to epilepsy, six were specific to surgical research, and nine were related to neurological/neurosurgical research. The remaining 165 reporting standards were applicable to research across various disciplines and included but were not limited to CONSORT (Consolidated Standards of Reporting Trails), STROBE (Strengthening the Reporting of Observational Studies in Epidemiology), and PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses). None of these required reporting factors associated with epilepsy surgery outcomes, such as duration of epilepsy or magnetic resonance imaging findings. SIGNIFICANCE: Reporting standards specific to epilepsy surgery are lacking, reflecting a gap in standards that may affect the quality of publications. Improving this gap with a set of specific reporting standards would ensure that epilepsy surgery studies are more transparent and rigorous in their design.

Safety-netting advice documentation out-of-hours: a retrospective cohort from 2013 to 2020.

BACKGROUND: Providing safety-netting advice (SNA) in out-of-hours primary care is a recognised standard of safe care but it is not known how frequently this occurs in practice. AIM: Assess the frequency and type of SNA documented in out-of-hours primary care and explore factors associated with its presence. DESIGN AND SETTING: Retrospective cohort using the Birmingham Out-of-hours General Practice Research Database. METHOD: A stratified sample of 30 adult consultation records per month from July 2013 to February 2020 were assessed using a safety-netting coding tool. Associations were tested using linear and logistic regression. RESULTS: The overall frequency of SNA per consultation was 78.0%, increasing from 75.7% (2014) to 81.5% (2019). The proportion of specific SNA and the average number of symptoms patients were told to look out for increased with time. The most common symptom to look out for was if the patients' condition worsened followed by if their symptoms persisted, but only one in five consultations included a time-frame to reconsult for persistent symptoms. SNA was more frequently documented in face-to-face treatment-centre encounters compared to telephone-consultations (Odds Ratio [OR]=1.77, p=0.02), for possible infections (OR=1.53, p=0.006), and less frequently for mental (vs. physical) health consultations (OR=0.33, p=0.002) and where follow-up was planned (OR=0.34, p<0.001). CONCLUSION: The frequency of SNA documented in OOH was higher than previously reported during in-hours care. Over time, the frequency of SNA and proportion that contained specific advice increased, however this study highlights potential consultations where SNA could be improved, such as mental health and telephone consultations.

The Cultural Evolution and Social Pressures of Liposuction Among Iraqi Women: Navigating Modern Beauty Standards Amidst Conservative Traditions.

This editorial explores the impact of societal transformation on Iraqi women's lives, particularly concerning beauty standards and cosmetic procedures like liposuction. It examines the influences of modernization, social media, and social pressures juxtaposed with traditional conservative values. The transition from repressive regimes to more open, albeit unstable, political landscapes has led to significant shifts in women's roles, with increased conservatism contrasting with emerging modernist influences. The role of social media in amplifying modern beauty ideals creates internal conflicts for women striving to balance these with traditional expectations. The growing acceptance of cosmetic procedures indicates a shift toward integrating modern beauty standards within Iraqi society.

Spatio-temporal evaluation of metals and metalloids in the water of high Andean livestock micro-watersheds, Amazonas, Peru.

Cattle ranching is a fundamental economic activity in northern Peru, where proper management of water resources is crucial. This study, a pioneer in the region, evaluated water quality and its suitability for human consumption, vegetable irrigation, and livestock production. It is also the first study to document the presence of metals and metalloids in vulnerable areas because they are located at the headwaters of river watersheds. The spatiotemporal evaluation of physicochemical parameters, metals, and metalloids was performed in five micro-watersheds (Cabildo, Timbambo, Pomacochas, Atuen, and Ventilla) from water samples collected in the dry season (October 2017) and wet season (March 2018). The parameters were analyzed using microwave plasma atomic emission spectrometry. The results were contrasted with international and Peruvian quality standards related to dairy cow production. The highest values of pH, total dissolved solids, and electrical conductivity were reported during the dry season, and the highest turbidity during the wet season. Of the metals evaluated, arsenic (As) was omnipresent in all the micro-watersheds, followed by lead (Pb). In contrast to World Health Organization regulations, concentrations of As, cadmium (Cd), Pb, and iron represent a risk; according to Peruvian regulations, As and Pb exceed the concentrations established for use in animal drinking water and vegetable irrigation, and according to water guidelines for dairy cattle, concentrations of As, Pb, Cd, and Al exceed the permitted limits. The high concentrations of these metals in the study area are attributable to a synergy between natural factors, such as Andean geology and livestock activity. The data reported will allow for proper water resource management, pollution prevention, and the design and adoption of mitigation measures.

Striking Differences in Kendo Headgear.

BACKGROUND:  Kendo, a martial art developed by the samurai, is rooted deep in Japanese culture with traditional armor that has seen little change over the past centuries. Despite its century-old design, kendo helmets are manufactured without third-party testing to verify their quality and effectiveness against head trauma. OBJECTIVE: To evaluate the effectiveness of different helmet stitching patterns and padding materials in mitigating impact forces that could lead to sports-related concussions (SRC) in kendo, and to assess variations in safety performance across different genders and kendo ranks (Dan and Kyu). METHODS: We collected data from 10 kendo practitioners (six males and four females), analyzing over 4,000 strikes using shinai on a sensor-equipped mannequin. Various helmet stitching patterns (ranging from 2 mm to 9 mm) and padding types (polyurethane-based and different thicknesses of cotton-based pads) were tested under controlled conditions simulating realistic impacts encountered in kendo practice. RESULTS: The results indicated that helmets with wider stitching patterns (e.g. 8 mm and 9 mm) generally offered better energy absorption, exhibiting statistically significant lower mean g-forces with a 95% confidence interval compared to tighter patterns (2 mm, 4 mm, 6 mm, and 8 mm x 2 mm) (p < 0.001). Additionally, the polyurethane-based padding outperformed cotton-based padding by a statistically significant reduction of impact force (p < 0.001). Significant differences in striking force were also observed between genders and ranks, with male and higher-rank (Dan) practitioners delivering stronger impacts (both p < 0.001). CONCLUSIONS: This study highlights the critical influence of helmet stitching patterns and padding materials on the protective capabilities against concussions in kendo. Even though helmets with narrower stitching patterns cost more, helmets with wider stitching patterns and polyurethane padding material provide enhanced safety benefits. We do not know how the difference in striking force between genders and ranks affects the outcome of a kendo match.

Multi-centric evaluation of Truenat MTB and MTB-RIF Dx assays for diagnosis of extrapulmonary tuberculosis.

Extra-pulmonary TB (EPTB) is difficult to diagnose due to paucibacillary nature of disease. Current study evaluated accuracy of Truenat MTB and MTB-Rif Dx (TN), for detection of Mycobacterium tuberculosis and resistance to rifampicin. Samples were collected from 2103 treatment naive adults with presumptive EPTB, and tested by smear microscopy, liquid culture (LC) (MGIT-960) and GeneXpert MTB/RIF (GX) (Microbiological Reference Standards, MRS). TN results were compared to MRS and Composite Reference Standards (CRS, Microbiology, histopathology, radiology, clinical features prompting decision to treat, response to treatment). CRS grouped patients into 551 confirmed, 1096 unconfirmed, and 409 as unlikely TB. TN sensitivity and specificity was 73.7% and 90.4% against GX. Against LC, Overall sensitivity of GX was 67.6%, while that of TN was 62.3%. Highest sensitivity by TN was observed in pus samples (89%) and highest specificity (92%) in CSF samples, similar to GX. TN sensitivity was better in fluid and biopsy samples and slightly inferior for lymph node aspirates compared to GX. TN sensitivity for RIF resistance detection was slightly superior to GX. TN and GX results were further compared to Clinical Reference Standards. TN detected 170 TB patients initiated on treatment missed by GX, while GX detected 113 such patients missed by TN. Of 124 samples with RIF resistance discordance between GX and TN, GX reported 103/124 as sensitive, 3/124 as indeterminate and 18 as resistant (13/18 samples had low/very low DNA load) while TN reported RIF resistance indeterminate in 103/111 low/very low DNA load samples. Due to paucibacillary nature of EPTB samples, culture yield was poor and phenotypic drug susceptibility testing failed to resolve the discordance. The study establishes TN at par with GX and can be utilized for quick and accurate diagnosis of EPTB.

Evaluating the Validity of International Standards of Height, Weight, and Body Mass Index on Jordanian Children and Adolescents.

BACKGROUND: the variations in a child's overall body shape and figure among different countries are attributable to differences in genetics, environmental factors, and the interaction between these elements. This study aims to evaluate the validity, reliability, and appropriateness of applying international growth standards to Jordanian children and adolescents aged 2-19 years old. METHODS: 65,828 Jordanian children and adolescents (43% males; 57% females) aged 2-19 years old were selected from the Hakeem Program database and various private schools across Jordan. Height-for-age, weight-for-age, and body mass index (BMI)-for-age were analyzed comparatively for Jordanian children and adolescents against international growth standards. The z-score for each record was computed based on international equations. RESULTS: Mean z-scores for height-for-age, weight-for-age, and BMI-for-age for both genders showed significant deviation from international standards across most age intervals. It was found that in most age groups, Jordanian children and adolescents were shorter and lighter than CDC and WHO standards, except for females at ages ≥ 16 years, who were heavier with higher BMI-for-age values than CDC standards based on weight-for-age and BMI-for-age equations. Moreover, Jordanian males at ages ≥ 12 years had lower BMI-for-age values than CDC standards. CONCLUSIONS: Jordanian children and adolescents showed significant deviations in their measurements from international standards and growth reference values. The development of a population-specific growth chart is highly recommended to enhance the accuracy of evaluating children's and adolescents' wellness.

ICP-MS As a Contributing Tool to Nontarget Screening (NTS) Analysis for Environmental Monitoring.

Due to the increasing number of chemicals released into the environment, nontarget screening (NTS) analysis is a necessary tool for providing comprehensive chemical analysis of environmental pollutants. However, NTS workflows encounter challenges in detecting both known and unknown pollutants with common chromatography high-resolution mass spectrometry (HRMS) methods. Identification of unknowns is hindered by limited elemental composition information, and quantification without identical reference standards is prone to errors. To address these issues, we propose the use of inductively coupled plasma mass spectrometry (ICP-MS) as an element-specific detector. ICP-MS can enhance the confidence of compound identification and improve quantification in NTS due to its element-specific response and unambiguous chemical composition information. Additionally, mass balance calculations for individual elements (F, Br, Cl, etc.) enable assessment of total recovery of those elements and evaluation of NTS workflows. Despite its benefits, implementing ICP-MS in NTS analysis and environmental regulation requires overcoming certain shortcomings and challenges, which are discussed herein.

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.