Design of the Prevention of Adult Caries Study (PACS): a randomized clinical trial assessing the effect of a chlorhexidine dental coating for the prevention of adult caries

Abstract Background Dental caries is one of the primary causes of tooth loss among adults. It is estimated to affect a majority of Americans aged 55 and older, with a disproportionately higher burden in disadvantaged populations. Although a number of treatments are currently in use for caries prevention in adults, evidence for their efficacy and effectiveness is limited. Methods/Design The Prevention of Adult Caries Study (PACS) is a multicenter, placebo-controlled, double-blind, randomized clinical trial of the efficacy of a chlorhexidine (10% w/v) dental coating in preventing adult caries. Participants (n = 983) were recruited from four different dental delivery systems serving four diverse communities, including one American Indian population, and were randomized to receive either chlorhexidine or a placebo treatment. The primary outcome is the net caries increment (including non-cavitated lesions) from baseline to 13 months of follow-up. A cost-effectiveness analysis also will be considered. Discussion This new dental treatment, if efficacious and approved for use by the Food and Drug Administration (FDA), would become a new in-office, anti-microbial agent for the prevention of adult caries in the United States. Trial Registration Number NCT0035787

Psychosocial predictors of weight regain in the weight loss maintenance trial

This study's purpose was to identify psychosocial predictors of weight loss maintenance in a multi-site clinical trial, following a group-based weight loss program. Participants (N = 1025) were predominately women (63 %) and 38 % were Black (mean age = 55.6 years; SD = 8.7). At 12 months, higher SF-36 mental health composite scores were associated with less weight regain (p < .01). For Black participants, an interaction existed between race and friends' encouragement for exercise, where higher exercise encouragement was related to more weight regain (p < .05). At 30 months, friends' encouragement for healthy eating was associated with more weight regain (p < .05), whereas higher SF-36 mental health composite scores were related to less weight regain (p < .0001). Perceived stress and select health-related quality of life indices were associated with weight regain; this relationship varied across gender, race, and treatment conditions. Temporal changes in these variables should be investigated for their impact on weight maintenance

Weight loss history as a predictor of weight loss: results from Phase I of the weight loss maintenance trial

Past studies have suggested that weight loss history is associated with subsequent weight loss. However, questions remain whether method and amount of weight lost in previous attempts impacts current weight loss efforts. This study utilized data from the Weight Loss Maintenance Trial to examine the association between weight loss history and weight loss outcomes in a diverse sample of high-risk individuals. Multivariate regression analysis was conducted to determine which specific aspects of weight loss history predict change in weight during a 6-month weight loss intervention. Greater weight loss was predicted by fewer previous weight loss attempts with assistance (p = 0.03), absence of previous dietary/herbal weight loss supplement use (p = 0.01), and greater maximum weight loss in previous attempts (p <0.001). Future interventions may benefit from assessment of weight loss history and tailoring of interventions based on past weight loss behaviors and outcomes

Weight Loss During the Intensive Intervention Phase of the Weight-Loss Maintenance Trial

To improve methods for long-term weight management, the Weight Loss Maintenance (WLM) trial, a four-center randomized trial, was conducted to compare alternative strategies for maintaining weight loss over a 30-month period. This paper describes methods and results for the initial 6-month weight-loss program (Phase I)

Design of the Prevention of Adult Caries Study (PACS): A randomized clinical trial assessing the effect of a chlorhexidine dental coating for the prevention of adult caries

<p>Abstract</p> <p>Background</p> <p>Dental caries is one of the primary causes of tooth loss among adults. It is estimated to affect a majority of Americans aged 55 and older, with a disproportionately higher burden in disadvantaged populations. Although a number of treatments are currently in use for caries prevention in adults, evidence for their efficacy and effectiveness is limited.</p> <p>Methods/Design</p> <p>The Prevention of Adult Caries Study (PACS) is a multicenter, placebo-controlled, double-blind, randomized clinical trial of the efficacy of a chlorhexidine (10% w/v) dental coating in preventing adult caries. Participants (n = 983) were recruited from four different dental delivery systems serving four diverse communities, including one American Indian population, and were randomized to receive either chlorhexidine or a placebo treatment. The primary outcome is the net caries increment (including non-cavitated lesions) from baseline to 13 months of follow-up. A cost-effectiveness analysis also will be considered.</p> <p>Discussion</p> <p>This new dental treatment, if efficacious and approved for use by the Food and Drug Administration (FDA), would become a new in-office, anti-microbial agent for the prevention of adult caries in the United States.</p> <p>Trial Registration Number</p> <p>NCT00357877</p

Investigation of hospital discharge cases and SARS-CoV-2 introduction into Lothian care homes

Background The first epidemic wave of severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) in Scotland resulted in high case numbers and mortality in care homes. In Lothian, over one-third of care homes reported an outbreak, while there was limited testing of hospital patients discharged to care homes. Aim To investigate patients discharged from hospitals as a source of SARS-CoV-2 introduction into care homes during the first epidemic wave. Methods A clinical review was performed for all patients discharges from hospitals to care homes from 1st March 2020 to 31st May 2020. Episodes were ruled out based on coronavirus disease 2019 (COVID-19) test history, clinical assessment at discharge, whole-genome sequencing (WGS) data and an infectious period of 14 days. Clinical samples were processed for WGS, and consensus genomes generated were used for analysis using Cluster Investigation and Virus Epidemiological Tool software. Patient timelines were obtained using electronic hospital records. Findings In total, 787 patients discharged from hospitals to care homes were identified. Of these, 776 (99%) were ruled out for subsequent introduction of SARS-CoV-2 into care homes. However, for 10 episodes, the results were inconclusive as there was low genomic diversity in consensus genomes or no sequencing data were available. Only one discharge episode had a genomic, time and location link to positive cases during hospital admission, leading to 10 positive cases in their care home. Conclusion The majority of patients discharged from hospitals were ruled out for introduction of SARS-CoV-2 into care homes, highlighting the importance of screening all new admissions when faced with a novel emerging virus and no available vaccine

SARS-CoV-2 Omicron is an immune escape variant with an altered cell entry pathway

Vaccines based on the spike protein of SARS-CoV-2 are a cornerstone of the public health response to COVID-19. The emergence of hypermutated, increasingly transmissible variants of concern (VOCs) threaten this strategy. Omicron (B.1.1.529), the fifth VOC to be described, harbours multiple amino acid mutations in spike, half of which lie within the receptor-binding domain. Here we demonstrate substantial evasion of neutralization by Omicron BA.1 and BA.2 variants in vitro using sera from individuals vaccinated with ChAdOx1, BNT162b2 and mRNA-1273. These data were mirrored by a substantial reduction in real-world vaccine effectiveness that was partially restored by booster vaccination. The Omicron variants BA.1 and BA.2 did not induce cell syncytia in vitro and favoured a TMPRSS2-independent endosomal entry pathway, these phenotypes mapping to distinct regions of the spike protein. Impaired cell fusion was determined by the receptor-binding domain, while endosomal entry mapped to the S2 domain. Such marked changes in antigenicity and replicative biology may underlie the rapid global spread and altered pathogenicity of the Omicron variant

Smoking cessation and change in diastolic blood pressure, body weight, and plasma lipids. MRFIT Research Group

Cigarette smoking cessation was examined for its impact on diastolic blood pressure, weight, and plasma lipids in 3,470 special intervention males in the Multiple Risk Factor Intervention Trial. Change in smoking status (quitters vs nonquitters) was not independently associated with change in diastolic blood pressure or the subsequent use of antihypertensive medication for smokers who were normotensive at entry. More quitters (35%) became hypertensive than nonquitters (27%, P less than 0.01), although the groups had similar baseline diastolic blood pressure levels. Weight gain subsequent to cessation probably contributed to this excess incidence of hypertension in quitters. Stepped-care antihypertensive therapy lowered diastolic blood pressure similarly for hypertensive quitters and nonquitters. Weight increases of 6 lb or more by the 72-month visit occurred in 47% of quitters vs 25% of nonquitters (P less than 0.01); quitters did not differ from nonquitters in their change in total kilocalories from baseline to the 72-month visit. Quitters who gained 6 lb or more tended to be less obese at baseline, be less physically active, and smoke more cigarettes per day than those who did not gain this amount. Finally, quitters relative to nonquitters experienced an adjusted increase of 2.4 mg/dl high-density lipoprotein cholesterol, but no difference in total or low-density lipoprotein cholesterol. The implications for intervention are discussed as they relate to the common, but not inevitable, increase in weight subsequent to cessation

Developing and testing new smoking measures for the Health Plan Employer Data and Information Set

OBJECTIVE: To develop and test items for the Health Plan Employee Data and Information Set (HEDIS) that assess delivery of the full range of provider-delivered tobacco interventions. MATERIALS AND METHODS: The authors identified potential items via literature review; items were reviewed by national experts. Face validity of candidate items was tested in focus groups. The final survey was sent to a random sample of 1711 adult primary care patients; the re-test survey was sent to self-identified smokers. RESULTS: The process identified reliable items to capture provider assessment of motivation and provision of assistance and follow-up. CONCLUSIONS: One can reliably assess patient self-report of provider delivery of the full range of brief tobacco interventions. Such assessment and feedback to health plans and providers may increase use of evidence-based brief interventions

Teen reach: Outcomes from a randomized, controlled trial of a tobacco reduction program for teens seen in primary medical care

Objective. To test the long-term efficacy of brief counseling plus a computer-based tobacco intervention for teens being seen for routine medical care. Methods. Both smoking and nonsmoking teens, 14 to 17 years of age, who were being seen for routine visits were eligible for this 2-arm controlled trial. Staff members approached teens in waiting rooms of 7 large pediatric and family practice departments within a group-practice health maintenance organization. Of 3747 teens invited at ≥1 visits, 2526 (67%) consented and were randomized to tobacco intervention or brief dietary advice. The tobacco intervention was individually tailored on the basis of smoking status and stage of change. It included a 30-second clinician advice message, a 10-minute interactive computer program, a 5-minute motivational interview, and up to two 10-minute telephone or inperson booster sessions. The control intervention was a 5-minute motivational intervention to promote increased consumption of fruits and vegetables. Follow-up smoking status was assessed after 1 and 2 years. Results. Abstinence rates after 2 years were significantly higher for the tobacco intervention arm, relative to the control group, in the combined sample of baseline smokers and nonsmokers (odds ratio [OR]: 1.23; 95% confidence interval [CI]: 1.03-1.47). Treatment effects were particularly strong among baseline self-described smokers (OR: 2.42; 95% CI: 1.40-4.16) but were not significant for baseline nonsmokers (OR: 1.25; 95% CI: 0.97-1.61) or for those who had experimented in the past month at baseline (OR: 0.95; 95% CI: 0.45-1.98). Conclusions. Brief, computer-assisted, tobacco intervention during routine medical care increased the smoking cessation rate among self-described smokers but was less effective in preventing smoking onset. Copyright © 2005 by the American Academy of Pediatrics