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: 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.

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.

Quality assessment of meta-analyses evaluating randomized clinical trials to improve the prognosis of septic shock: an overview of systematic reviews.

Objective: Clinical guidelines for the treatment of septic shock are based on the studies with the best scientific evidence, which are meta-analyses of clinical trials. However, these meta-analyses may have methodological limitations that prevent their conclusions from being extrapolated to routine clinical practice. Therefore, the objective of this study is to determine the quality of these meta-analyses through a systematic review.Methods: In this systematic review, we searched MEDLINE, Scopus and EMBASE from inception to May 2019. We selected meta-analyses from clinical trials that determined the effectiveness of an intervention in reducing the incidence of mortality in patients with septic shock. All items were extracted from the Overview Quality Assessment Questionnaire (OQAQ), which collects information from both systematic reviews and meta-analyses.Results: A total of 34 studies were included. Most elements of the OQAQ were conducted satisfactorily, although 35.3% of meta-analyses did not use a quality assessment of the studies included in other analyses. In 52.9% of meta-analyses, the quality of the studies was high or very high.Conclusions: The methods used to obtain the results should be taken into account when recommending an intervention to treat septic shock if the evidence comes from a meta-analysis of the analyzed characteristics.

Examining the role of funders in ensuring value and reducing waste in research: An organizational case-study of the Patient-Centered Outcomes Research Institute.

International experts have recommended actions that funders can take to improve the value of research investments. They state that self-assessment and public sharing are the basis for accountability and improvement. We examined our policies and practice to determine the extent to which the Patient-Centered Outcomes Research Institute's (PCORI) policies and practices as a research funder align with international best practice recommendations. A self-audit of current policies and practice against 17 recommendations and 35 sub-recommendations representing five major stages of research production, based on adapted methods used for self-assessment by another funder, was performed.  Fit of existing PCORI policies and practices with 35 sub-recommendations, qualitative assessment of adequacy (area of strength; area of partial strength; area of growth; not applicable) for 17 recommendations for five stages of research production was assessed. Of the 17 recommendations, 15 were applicable to PCORI's research mission and focus.  PCORI has policies and practices in place for all elements of six recommendations ("area of strength") and policies that address each element but with some still in active development for three ("area of partial strength"). PCORI is partially addressing six of the 15 relevant recommendations ("area of growth"). Areas for growth include making study protocols publicly available, improving policies on data sharing, and enhancing collaboration with other funders to reduce redundant funding. A voluntary consortium of international funders is underway to encourage further progress, including additional self-assessment and public sharing for accountability. These findings indicate PCORI has undertaken efforts to align its funding practices with international recommendations to ensure the value of public dollars invested in research.  Further efforts will likely require additional coordination and collaboration between funders and stakeholders.

Sex bias in basic science and translational otolaryngology research.

OBJECTIVES/HYPOTHESIS: Recent studies revealed sex bias in surgical research. Although many diseases exhibit sex-based clinically relevant differences, otolaryngology research has not been evaluated for sex reporting and sex-based analysis. We postulate that a similar bias is prevalent in otolaryngology literature. STUDY DESIGN: Literature review. METHODS: Articles published from 2016 to 2017 in The Laryngoscope, Otolaryngology-Head and Neck Surgery, and JAMA Otolaryngology-Head and Neck Surgery were reviewed. Articles with animal subjects, human subject cells, or commercial cell lines were included. Data collected included study type, cell/animal sex, and sex-based data analysis. RESULTS: One hundred forty-four basic/translational research articles were identified. Sixty-nine (47.9%) of those lacked sex reporting. Of 75 studies that reported sex, 22 (29.3%) included both sexes, and 11 (14.7%) analyzed data by sex. One hundred five (72.9%) used animal subjects, of which 54 (51.9%) lacked sex breakdown. Among animal studies, 48/105 included only one sex, and three articles analyzed data by sex. Fifty-four studies used commercial cell lines (N = 23) or human/animal subject cells (N = 31). Among cell groups, 28/54 (51.9%) were of unknown sex, and seven were single sex. Eight (14.8%) studies included data analysis by sex. Domestic studies exhibited a lower rate of sex reporting in both animal and cell studies, and a lower rate of sex-based analysis in cell studies. CONCLUSIONS: Sex may influence outcomes significantly but is underreported and underanalyzed in basic/translational otolaryngology research. Because this research frequently lays the groundwork for clinical trials and standards of care, future research must address these sex-based discrepancies. LEVEL OF EVIDENCE: NA Laryngoscope, 129:613-618, 2019.

Evidence supporting regulatory-decision making on orphan medicinal products authorisation in Europe: methodological uncertainties.

BACKGROUND: To assess uncertainty in regulatory decision-making for orphan medicinal products (OMP), a summary of the current basis for approval is required; a systematic grouping of medical conditions may be useful in summarizing information and issuing recommendations for practice. METHODS: A grouping of medical conditions with similar characteristics regarding the potential applicability of methods and designs was created using a consensus approach. The 125 dossiers for authorised OMP published between 1999 and 2014 on the EMA webpage were grouped accordingly and data was extracted from European Public Assessment Reports (EPARs) to assess the extent and robustness of the pivotal evidence supporting regulatory decisions. RESULTS: 88% (110/125) of OMP authorizations were based on clinical trials, with 35% (38/110) including replicated pivotal trials. The mean (SD) number of pivotal trials per indication was 1.4 (0.7), and the EPARs included a median of three additional non-pivotal supportive studies. 10% of OMPs (13/125) were authorised despite only negative pivotal trials. One-third of trials (53/159) did not include a control arm, one-third (50/159) did not use randomisation, half the trials (75/159) were open-label and 75% (119/159) used intermediate or surrogate variables as the main outcome. Chronic progressive conditions led by multiple system/organs, conditions with single acute episodes and progressive conditions led by one organ/system were the groups where the evidence deviated most from conventional standards. Conditions with recurrent acute episodes had the most robust datasets. The overall size of the exposed population at the time of authorisation of OMP - mean(SD) 190.5 (202.5) - was lower than that required for the qualification of clinically-relevant adverse reactions. CONCLUSIONS: The regulatory evidence supporting OMP authorization showed substantial uncertainties, including weak protection against errors, substantial use of designs unsuited for conclusions on causality, use of intermediate variables, lack of a priorism and insufficient safety data to quantify risks of relevant magnitude. Grouping medical conditions based on clinical features and their methodological requirements may facilitate specific methodological and regulatory recommendations for the study of OMP to strengthen the evidence base.

Sex bias in rhinology research.

BACKGROUND: Analysis of general surgery literature has revealed noteworthy sex bias and underreporting. Our objective was to determine the prevalence of sex bias and underreporting in rhinology. METHODS: All articles in 2016 issues of Rhinology, the American Journal of Rhinology and Allergy (AJRA), and the International Forum of Allergy and Rhinology (IFAR) were reviewed. Of 369 articles, 248 met inclusion criteria. Excluded studies were cadaveric, meta-analysis/review, and editorial. Data collected included study type, demographics, and sex-based statistical analysis. RESULTS: There were 202 clinical and 46 basic science/translational studies. From 188 of 202 clinical studies with known sex, 1 included participants of a single sex. Sex matching >50% (SM50 ) was found in 81.9%, and 55.9% performed sex-based statistical analysis. Domestic clinical studies performed sex-based analysis more frequently than international (54.9% vs 44.4%) and exhibited a higher rate of SM50 (84.5% vs 80.3%), though these differences were not statistically significant. For basic/translational studies, 54.5% (24/44) provided sex breakdown. Among these, 29.2% included 1 sex, and 8.3% performed sex-based analysis. Of 10 using animals, 70.0% utilized 1 sex. The remaining 30.0% did not report sex. None of 4 cell line studies reported cell sex. Less than half (46.2%) of domestic and 56.3% of international studies reported sex breakdown; 7.7% of domestic and 3.0% of international studies performed sex-based analysis. CONCLUSION: Although sex may impact outcomes, research without sex reporting and analysis is prevalent, particularly among basic science/translational studies. Future research must account for sex in demographics and analysis to best inform evidence-based clinical guidelines.

Participant retention practices in longitudinal clinical research studies with high retention rates.

BACKGROUND: There is a need for improving cohort retention in longitudinal studies. Our objective was to identify cohort retention strategies and implementation approaches used in studies with high retention rates. METHODS: Longitudinal studies with ≥200 participants, ≥80% retention rates over ≥1 year of follow-up were queried from an Institutional Review Board database at a large research-intensive U.S. university; additional studies were identified through networking. Nineteen (86%) of 22 eligible studies agreed to participate. Through in-depth semi-structured interviews, participants provided retention strategies based on themes identified from previous literature reviews. Synthesis of data was completed by a multidisciplinary team. RESULTS: The most commonly used retention strategies were: study reminders, study visit characteristics, emphasizing study benefits, and contact/scheduling strategies. The research teams were well-functioning, organized, and persistent. Additionally, teams tailored their strategies to their participants, often adapting and innovating their approaches. CONCLUSIONS: These studies included specialized and persistent teams and utilized tailored strategies specific to their cohort and individual participants. Studies' written protocols and published manuscripts often did not reflect the varied strategies employed and adapted through the duration of study. Appropriate retention strategy use requires cultural sensitivity and more research is needed to identify how strategy use varies globally.

The CROWN Initiative: journal editors invite researchers to develop core outcomes in women's health.

ᅟ.

Evidence-based vector control? Improving the quality of vector control trials.

Vector-borne diseases (VBDs) such as malaria, dengue, and leishmaniasis cause a high level of morbidity and mortality. Although vector control tools can play a major role in controlling and eliminating these diseases, in many cases the evidence base for assessing the efficacy of vector control interventions is limited or not available. Studies assessing the efficacy of vector control interventions are often poorly conducted, which limits the return on investment of research funding. Here we outline the principal design features of Phase III vector control field studies, highlight major failings and strengths of published studies, and provide guidance on improving the design and conduct of vector control studies. We hope that this critical assessment will increase the impetus for more carefully considered and rigorous design of vector control studies.

The CROWN Initiative: journal editors invite researchers to develop core outcomes in women's health.

ᅟ.