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.

American dental hygienists' attitudes towards chairside medical screening in a dental setting.

OBJECTIVES: Targeted screening for medical conditions in a dental setting can be an effective strategy for early identification of individuals at increased disease risk. Dentists, patients and physicians have a favourable attitude towards this strategy. Given that dental hygienists (DHs) are involved in preventive and educational activities, this seems like a natural extension to their roles. We report on the attitudes of American DHs towards chairside medical screening. METHODS: A 5-point Likert scale (1 = very important/willing, 5 = very unimportant/unwilling) survey was mailed to a nationwide random sample of US practicing DHs. Descriptive statistics were used for all questions, and the Friedman nonparametric analysis of variance was used for multi-element questions. RESULTS: A total of 3133 respondents returned the completed questionnaires for an effective response rate of 49.2% and a margin of error 1.8%. The majority of respondents felt it was important to perform/conduct chairside screening for hypertension (94%), diabetes mellitus (89%), cardiovascular disease (85%), HIV (79%) and hepatitis infection (78%); were willing to refer a patient for medical consult (94%), conduct screening that yields immediate results (85%); and were willing to collect the data/samples needed (57-95%). The most important considerations were dentist/owner support (98%), training (97%), patient willingness (98%) and time (98%). CONCLUSION: Similar to dentists, physicians and patients, the majority of the DHs had a favourable attitude towards chairside medical screening. Integrating the DH into screening activities is likely to require additional training and education regarding the diseases of interest, something that could be accomplished through continuing education courses and eventually incorporation into the educational curriculum.

Saliva, diagnostics, and dentistry.

Saliva, a scientific and clinical entity familiar to every oral health researcher and dental practitioner, has emerged as a translational and clinical commodity that has reached national visibility at the National Institutes of Health and the President's Office of Science and Technology. "Detecting dozens of diseases in a sample of saliva" was issued by President Obama as one of the 14 Grand Challenges for biomedical research in the 21(st) Century (National Economic Council, 2010). In addition, NIH's 2011 Government Performance Report Act (GPRA) listed 10 initiatives in the high-risk long-term category (Collins, 2011). The mandate is to determine the efficacy of using salivary diagnostics to monitor health and diagnose at least one systemic disease by 2013. The stage is set for the scientific community to capture these national and global opportunities to advance and substantiate the scientific foundation of salivary diagnostics to meet these goals. A specific calling is to the oral, dental, and craniofacial health community. Three areas will be highlighted in this paper: the concept of high-impact diagnostics, the role of dentists in diagnostics, and, finally, an infrastructure currently being developed in the United Kingdom--The UK Biobank--which will have an impact on the translational and clinical utilizations of saliva.

The Walden House Young Adult HIV project: meeting the needs of multidiagnosed youth.

Walden House, Inc.'s Young Adult Human Immunodeficiency Virus (HIV) (YAH) project is supported by the Special Projects of National Significance Program of the Health Resources and Services Administration (SPNS-HRSA). This project has served 512 high-risk young people (ages 13-25 years), 101 of them living with HIV/acquired immunodeficiency syndrome (AIDS). The YAH project offers treatment services and a coordinated support system to adolescents and young adults who are in need of HIV/AIDS services as well as behavioral health care; all clients suffer from multiple diagnoses. This system includes medical and psychological assessment, referral and coordination; therapy and counseling services; transportation; peer education and counseling; legal information and referral; and case management for long-term options. YAH provides HIV testing access, pretest and posttest counseling, HIV and sexually transmitted disease education, HIV-positive speakers as role models, and community-based outreach. YAH also serves as a resource within Walden House to spur enhancement of service provision for HIV care as well as programming for young people. The emphasis is on providing a comprehensive continuum of services, with the case manager and peer staff coordinating services to try to meet the diverse needs of each client. The complexity and intensity of the target population's needs challenge the traditional models of care. This project provided almost 4 h daily of cost-effective rehabilitation programming to each client, increased participants' self-reported measures of well-being, and increased staff's ability to deal with HIV issues.

Design and baseline participant characteristics of the Human Immunodeficiency Virus Epidemiology Research (HER) Study: a prospective cohort study of human immunodeficiency virus infection in US women.

The prospective, multisite human immunodeficiency (HIV) Epidemiology Research Study was established to define the biologic, psychologic, and social effects of HIV infection on the health of US women. From 1993 to 1995, a total of 871 HIV-infected women and 439 demographically matched, uninfected women aged 16-55 years, half of whom reported injection drug use and half of whom reported only sexual risk behaviors, were recruited in four US cities. Two sites recruited primarily from medical/drug therapy care settings, and two recruited from community sources. Women consented to biannual interviews; physical examination; blood, urine, and cervicovaginal specimen collection and repository; laboratory assays; and abstraction of outpatient and inpatient medical records to document HIV and acquired immunodeficiency syndrome-related diagnoses. Retention was greater than 88% at the third 6-month follow-up. Lower retention was associated with currently injecting drugs, not having dependent children, and not being infected with HIV at enrollment. In addition to the core study, a variety of nested studies are under way, some in collaboration with other HIV cohorts and various Public Health Service agencies. This cohort is distinct from other HIV longitudinal cohorts in the diversity of its participants and the comprehensive range of measures to study prospectively the biomedical, social, and emotional effects of the HIV epidemic on infected women and those whose behavior puts them at high risk of infection.

Vitamin A deficiency and maternal-infant transmissions of HIV in two metropolitan areas in the United States.

OBJECTIVE: To determine whether vitamin A deficiency is associated with maternal-infant HIV transmission among HIV-infected pregnant women in two United States cities. METHODS: Third trimester serum vitamin A levels were evaluated using high-performance liquid chromatography in 133 HIV-infected women who delivered livebirths during May 1986 to May 1994 and whose infants had known HIV infection status. RESULTS: Sixteen per cent (seven out of 44) of the transmitting mothers and 6% (five out of 89) of the non-transmitting mothers had severe vitamin A deficiency (< 0.70 mumol/l; P = 0.05). Maternal-infant transmission was also associated with prematurity < 37 weeks gestation (P = 0.02), and Cesarean section delivery (P = 0.04), CD4 percentage (P = 0.03) and marginally associated with duration of membrane rupture of > or = 4 h (P = 0.06) by univariate analysis. In a multivariate logistic regression model, severe vitamin A deficiency [adjusted odds ratio (AOR), 5.05; 95% confidence interval (CI), 1.20-21.24], Cesarean section delivery (AOR, 3.75; 95% CI, 1.10-12.87), and prematurity (AOR, 2.25; 95% CI, 1.22-4.13) were associated with transmission after adjusting for CD4+ percentage, and duration of membrane rupture. CONCLUSION: Increased risk of maternal-infant transmission was associated with severe vitamin A deficiency among non-breastfeeding women in these cohorts from the United States.

HIV-1 seroprevalence in chest clinic and hospital tuberculosis patients in New York City, 1989-1991.

OBJECTIVE: To describe more fully HIV-1 and tuberculosis (TB) coinfection in TB patients attending New York City Department of Health chest clinics (1989-1991) and one inner-city hospital (1990-1991). DESIGN: An unlinked serosurvey using HIV-1-antibody testing of remnant blood specimens collected for routine medical purposes. SUBJECTS: A total of 1414 clinic and 856 hospital patients. OUTCOME MEASURES: HIV seropositivity and TB infection/disease. RESULTS: A total of 327 (23%) of the clinic patients were HIV-1-positive, with a significantly higher seroprevalence in men (29 versus 15%, P < 0.001) and in young and middle-aged adults aged 30-50 years (P < 0.001). HIV-1 prevalence by TB diagnostic class was: class 2 (purified protein derivative-positive and chest radiograph-negative), 11% (64 out of 570); class 3 (active disease), 34% (197 out of 582); class IV (old/inactive disease), 30% (39 out of 130). Of the hospital patients 487 (57%) were HIV-1-positive. HIV-1 seroprevalence was 55% for those who were identified or believed to be HIV-1-negative on admission as indicated on the medical chart. HIV-1 seroprevalence in the clinic population decreased initially, but later increased, although not to study onset levels. CONCLUSIONS: There is considerable overlap between the TB and HIV epidemics in New York City; a part of the increasing TB incidence may be independent of HIV coinfection. The control of TB will necessitate prompt diagnosis of TB and HIV-1, appropriate TB treatment and/or chemoprophylaxis, and a greater commitment to tackle the social conditions associated with the spread of the disease.

HIV-1 infection among New York City inmates.

A blinded seroprevalence survey for HIV-1 infection was conducted among individuals entering New York City (NYC) prisons in 1989. Data collected included age group, race/ethnicity, syphilis serologic results and self-admitted drug use. Remnant serum specimens were tested for HIV-1 antibody by enzyme-linked immunosorbent assay and confirmed by Western blot. Of 2236 inmates surveyed, 413 (18.5%) were HIV-1 positive. Rates varied by subgroup, and were higher for women than men (25.8 versus 16.1%; odds ratio 1.8; P less than 0.01), for drug users than inmates who denied drug use (25 versus 14%; odds ratio 2.3; P less than 0.01), for intravenous heroin users (43 versus 15% in drug users not using heroin), and for inmates with positive rapid plasma reagin test (RPR) results (34.5 versus 16.1% in RPR-negative inmates). Use of intravenous heroin was most strongly related, by logistic regression, to HIV-1 seropositivity. The results are among the highest found in US inmates, and suggest that there were 12,500 seropositive individuals incarcerated in 1989. This represents approximately 10% of the estimated number of seropositive individuals in NYC. The NYC Correctional System should be viewed as a front-line institution in the fight against AIDS through provision of HIV-related prevention services and clinical care, and drug treatment.

Measles-associated diarrhea in hospitalized children in Lima, Peru: pathogenic agents and impact on growth.

Because the causes of measles-associated diarrhea are not well known, 0- to 5-year-old children presenting to the hospital with measles-associated diarrhea (cases, n = 77) or acute diarrhea only (controls, n = 77) were compared. Growth and diarrheal morbidity were evaluated for 1 month after acute illness. Campylobacter jejuni was more frequently isolated from cases (31%) than controls (16%; P = .03). Rotavirus was absent in all cases versus 28% of controls (P less than .001). Incidence density for new episodes of diarrhea was significantly greater in cases (6.5 vs. 4.1; odds ratio, 1.6; confidence intervals, 1.09-2.34; P = .01), as was duration of episodes (3 vs. 2 days, P = .02). Both groups showed similar positive cumulative percentage weight gains throughout follow-up. These data support the theory of measles as a risk factor for developing diarrhea. The bacteriologic and virologic findings may reflect the immunologic response of the host to measles infection.

Single dose piperazine therapy for Ascaris lumbricoides: an unsuccessful method of promoting growth.

One-hundred eighty-five Bangladeshi children age 1 1/2 to 8 yr with no Ascaris lumbricoides infection or with light, moderate, or heavy infection were randomly assigned to treatment of placebo groups, with treatment given in a double-blind fashion. The groups were comparable for nutritional and socioeconomic parameters. Treatment consisted of a single dose of piperazine citrate administered twice within a 2-wk period. The cure rates for the low, moderate, and heavy A. lumbricoides infected subgroups were 53, 31, and 36%, respectively. With more severe infections, worm eradication was more difficult and the rate of reinfection after treatment was more rapid. The rate of reinfection was significantly different for the low A. lumbricoides infected treatment and placebo subgroups for 5 months after treatment, for the moderate treatment and placebo subgroups for 3 months after treatment, and for the heavy A. lumbricoides infected treatment and placebo subgroups there was a difference, although not significant, for 1 month after treatment. Anthropometric measurements were obtained for a period of 11 months. Analysis of covariance revealed no significant difference for change of weight, change of height, weight-for age, weight-for-height, height-for-age, triceps skinfold, midarm circumference, and the abdominal girth to chest circumference ratio between the treatment and placebo groups after drug administration. The results of this study do not support single dose worm therapy as a means to enhance growth.