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.

Tree-based modeling of complex interactions of phosphorus loadings and environmental factors.

Phosphorus (P) enrichment has been observed in the historic oligotrophic Greater Everglades in Florida mainly due to P influx from upstream, agriculturally dominated, low relief drainage basins of the Everglades Agricultural Area (EAA). Our specific objectives were to: (1) investigate relationships between various environmental factors and P loads in 10 farm basins within the EAA, (2) identify those environmental factors that impart major effects on P loads using three different tree-based modeling approaches, and (3) evaluate predictive models to assess P loads. We assembled thirteen environmental variable sets for all 10 sub-basins characterizing water level management, cropping practices, soils, hydrology, and farm-specific properties. Drainage flow and P concentrations were measured at each sub-basin outlet from 1992-2002 and aggregated to derive monthly P loads. We used three different tree-based models including single regression trees (ST), committee trees in Bagging (CTb) and ARCing (CTa) modes and ten-fold cross-validation to test prediction performances. The monthly P loads (MPL) during the monitoring period showed a maximum of 2528 kg (mean: 103 kg) and maximum monthly unit area P loads (UAL) of 4.88 kg P ha(-1) (mean: 0.16 kg P ha(-1)). Our results suggest that hydrologic/water management properties are the major controlling variables to predict MPL and UAL in the EAA. Tree-based modeling was successful in identifying relationships between P loads and environmental predictor variables on 10 farms in the EAA indicated by high R(2) (>0.80) and low prediction errors. Committee trees in ARCing mode generated the best performing models to predict P loads and P loads per unit area. Tree-based models had the ability to analyze complex, non-linear relationships between P loads and multiple variables describing hydrologic/water management, cropping practices, soil and farm-specific properties within the EAA.

Malaria drug and vaccine trials in Africa: obstacles and opportunities.

There are several new treatments and vaccine technologies in clinical development for childhood malaria that have arrived in the clinical phase of evaluation during the past 5-10 years. This is a long-awaited change as until this time there had been little in the pipeline. As these products progress, evaluating them in the populations for whom they are being developed is becoming increasingly challenging. Many more capable trial sites are required and thousands of children and their parents need to be willing to take part in all the clinical trials that will be necessary if even a handful of these products make it through to obtaining a marketing approval license. Then, beyond licensure, these products will need to be assessed in more 'real-life' phase IV trials to establish whether they can truly impact the high level of mortality that malaria brings to the under-five population in Africa. Here we explore the issues that face both the trial sites and the product developers and present how this opportunity should be utilised to develop experienced African clinical researchers and facilities alongside getting these products through into public health use.

Approaching the community about screening children for a multicentre malaria vaccine trial.

Community sensitisation, as a component of community engagement, plays an important role in strengthening the ethics of community-based trials in developing countries and is fundamental to trial success. However, few researchers have shared their community sensitisation strategies and experiences. We report on our perspective as researchers on the sensitisation activities undertaken for a phase II malaria vaccine trial in Kilifi District (Kenya) and Korogwe District (Tanzania), with the aim of informing and guiding the operational planning of future trials. We report wide variability in recruitment rates within both sites; a variability that occurred against a backdrop of similarity in overall approaches to sensitisation across the two sites but significant differences in community exposure to biomedical research. We present a range of potential factors contributing to these differences in recruitment rates, which we believe are worth considering in future community sensitisation plans. We conclude by arguing for carefully designed social science research around the implementation and impact of community sensitisation activities.

The illusion of certainty and the certainty of illusion: a caution when reading scientific articles.

Critical thinking is necessary to read the scientific literature. However, in addition to questions about the science, often one must also question the meaning of the text. This article provides an example of the analyses needed to understand a single sentence. In so doing, it raises several interesting issues of meaning, measurement, statistical analyses, and the form in which results are presented and interpreted.

Katsu: traditional Japanese resuscitation methods.

Twelve traditional Japanese resuscitation methods, called Katsu, are described, and their history and medical aspects are compared with those of traditional Western methods of manual resuscitation. Five katsu, developed parallel to but independently of traditional Western methods, are inferior to CPR and are of historical interest only. Seven katsu not evaluated by Western researchers could be valuable if proven effective because they can be applied where CPR cannot.

Efficacy of laser interferometry in predicting visual result of YAG laser posterior capsulotomy.

One hundred fifteen patients with cloudy posterior capsules that required capsulotomies were evaluated by laser interferometry. The predicted acuity was within one line of postoperative acuity in 44 patients (38.3%) and within two lines in 73 patients (63.5%). The correlation coefficient between the predicted and actual post-capsulotomy acuities was 0.38. However, the predicted retinal visual acuity was compared to postoperative Snellen visual acuity and found to differ by an average of three lines. A large number of false negative results reduced the clinical usefulness of the test.