Atraumatic Restorative Treatments in Australian Aboriginal Communities: A Cluster-randomized Trial

2020 ◽  
pp. 238008442096394
Author(s):  
P. Arrow ◽  
S. Piggott ◽  
S. Carter ◽  
R. McPhee ◽  
D. Atkinson ◽  
...  
Keyword(s):  
Intervention Group ◽  
Cluster Randomized Trial ◽  
Caries Experience ◽  
Atraumatic Restorative Treatment ◽  
Model Of Care ◽  
Aboriginal Communities ◽  
Restorative Treatment ◽  
Cluster Randomized ◽  
Delayed Intervention

Introduction: The management of early childhood caries (ECC) is challenging. Objectives: A model of care based on Atraumatic Restorative Treatment and the Hall Technique (ART-HT) to manage ECC was evaluated among remote Aboriginal communities in Australia. Methods: Aboriginal communities in the North-West of Western Australia were invited to participate and consenting communities were randomized into early or delayed intervention for the management of ECC. Children were examined at baseline and at the 11-mo follow-up. The early intervention group (test) was provided with the ART-based dental care at baseline while the delayed intervention group (control) was advised to seek care through the usual care options available within the community. At follow-up, both groups were examined by calibrated examiners, and were offered care using the ART-HT approach. Changes from baseline to follow-up in caries experience were tested using paired tests. Multivariate analysis after multiple imputation of missing data used generalised estimating equation (GEE) controlling for clustering within communities. Results: A total of 25 communities and 338 children (mean age = 3.6 y, SD 1.7) participated in the study (test = 177). At follow-up, 231 children were examined (68% retention, test = 125). At follow-up, children in the test group had more filled teeth (test filled teeth = 1.2, control filled teeth = 0.2, P < 0.001) and decreased levels of decayed teeth (mean test = 0.7 fewer teeth with decay, mean control = 1.0 more tooth with decay, P < 0.001). GEE analysis controlled for baseline caries experience, age, sex, and community water fluoride levels found increased rates of untreated decayed teeth (RR = 1.4, P = 0.02) and decreased rates of filled teeth (RR = 0.2, P < 0.001) at follow-up among the control group. Conclusion: A model of care relying on the principles of minimally invasive atraumatic approaches enabled the delivery of effective dental services to young children (<6 y) in remote Aboriginal Australian communities resulting in increased levels of care and improved oral health. Knowledge Transfer Statement: This cluster-randomized trial tested a multi-component model of dental care to young children with ECC in remote Aboriginal communities in Australia. The intervention, based on the atraumatic approaches using minimally invasive techniques encompassing preventive care, Atraumatic Restorative Treatment and the Hall Technique (ART-HT), delivered more restorative care and reduced the incidence of caries. This model of care was more effective than available standard care and should be incorporated into mainstream service delivery programs.

scholarly journals Comparative Effectiveness of Two Nonsurgical Treatments to Reduce Oral Health Disparities From Untreated Tooth Decay in Older Adults: Protocol for a Cluster Randomized Trial (Preprint)

2020 ◽  
Author(s):  
Suchitra Nelson ◽  
Jeffrey M Albert ◽  
Peter Milgrom
Keyword(s):  
Older Adults ◽  
Dental Caries ◽  
Low Income ◽  
Cluster Randomized Trial ◽  
Fluoride Varnish ◽  
Atraumatic Restorative Treatment ◽  
Silver Diamine Fluoride ◽  
Restorative Treatment ◽  
Cluster Randomized ◽  
Caries Lesions

BACKGROUND The majority of dental caries lesions in older adults are at the gumline, at the edges of failed fillings and crowns, and in the surfaces of roots after gum recession. These lesions are difficult to restore with conventional surgical treatments using a dental drill and restorations often fail. Clinical guidelines are general and apply treatments that were designed for younger individuals in the dental care of older adults. OBJECTIVE This study will compare the effectiveness of 2 evidence-based nonsurgical strategies to manage dental caries lesions in adults aged 62 or older: (1) biannual topical application of silver diamine fluoride versus (2) atraumatic restorative treatment + biannual fluoride varnish. METHODS A cluster randomized clinical trial is being conducted in 22 publicly subsidized and other low-income housing facilities/sites (Arm 1: 11 sites, 275 participants; Arm 2: 11 sites, 275 participants). At baseline, participants will be screened for caries lesions. Those with nonurgent lesions will be treated according to the treatment arm to which the housing site was randomly assigned. The primary outcomes are caries lesion arrest, tooth sensitivity, and tooth pain at 52 weeks after treatment. Analytic methods for the primary aim include a generalized estimating equation approach to determine noninferiority of silver diamine fluoride relative to atraumatic restorative treatment + fluoride varnish treatment. RESULTS The trial was funded in April 2019. Enrollment began in September 2019 and results are expected in June 2023. CONCLUSIONS This study will inform the standard of care for treating caries lesions in older adults. If effective, either of these interventions has broad applicability in clinical and community-based settings. CLINICALTRIAL ClinicalTrials.gov NCT03916926; https://clinicaltrials.gov/ct2/show/NCT03916926 INTERNATIONAL REGISTERED REPORT DERR1-10.2196/17840

scholarly journals Comparative Effectiveness of Two Nonsurgical Treatments to Reduce Oral Health Disparities From Untreated Tooth Decay in Older Adults: Protocol for a Cluster Randomized Trial

10.2196/17840 ◽  
2020 ◽  
Vol 9 (9) ◽  
pp. e17840
Author(s):  
Suchitra Nelson ◽  
Jeffrey M Albert ◽  
Peter Milgrom
Keyword(s):  
Older Adults ◽  
Dental Caries ◽  
Low Income ◽  
Cluster Randomized Trial ◽  
Fluoride Varnish ◽  
Atraumatic Restorative Treatment ◽  
Silver Diamine Fluoride ◽  
Restorative Treatment ◽  
Cluster Randomized ◽  
Caries Lesions

Background The majority of dental caries lesions in older adults are at the gumline, at the edges of failed fillings and crowns, and in the surfaces of roots after gum recession. These lesions are difficult to restore with conventional surgical treatments using a dental drill and restorations often fail. Clinical guidelines are general and apply treatments that were designed for younger individuals in the dental care of older adults. Objective This study will compare the effectiveness of 2 evidence-based nonsurgical strategies to manage dental caries lesions in adults aged 62 or older: (1) biannual topical application of silver diamine fluoride versus (2) atraumatic restorative treatment + biannual fluoride varnish. Methods A cluster randomized clinical trial is being conducted in 22 publicly subsidized and other low-income housing facilities/sites (Arm 1: 11 sites, 275 participants; Arm 2: 11 sites, 275 participants). At baseline, participants will be screened for caries lesions. Those with nonurgent lesions will be treated according to the treatment arm to which the housing site was randomly assigned. The primary outcomes are caries lesion arrest, tooth sensitivity, and tooth pain at 52 weeks after treatment. Analytic methods for the primary aim include a generalized estimating equation approach to determine noninferiority of silver diamine fluoride relative to atraumatic restorative treatment + fluoride varnish treatment. Results The trial was funded in April 2019. Enrollment began in September 2019 and results are expected in June 2023. Conclusions This study will inform the standard of care for treating caries lesions in older adults. If effective, either of these interventions has broad applicability in clinical and community-based settings. Trial Registration ClinicalTrials.gov NCT03916926; https://clinicaltrials.gov/ct2/show/NCT03916926 International Registered Report Identifier (IRRID) DERR1-10.2196/17840

scholarly journals Standing Meetings Are Feasible and Effective in Reducing Sitting Time among Office Workers—Walking Meetings Are Not: Mixed-Methods Results on the Feasibility and Effectiveness of Active Meetings Based on Data from the “Take a Stand!” Study

2020 ◽  
Vol 17 (5) ◽  
pp. 1713 ◽  
Author(s):  
Ida H Danquah ◽  
Janne S Tolstrup
Keyword(s):  
Mixed Methods ◽  
Intervention Group ◽  
Cluster Randomized Trial ◽  
Office Workers ◽  
Sitting Time ◽  
Explorative Study ◽  
Multiple Components ◽  
Cluster Randomized ◽  
Objectively Measured

Active meetings (standing or walking) have the potential to reduce sitting time among office workers. The aim of the present study was to explore the feasibility and effectiveness of standing and walking meetings. The “Take a Stand!” study was a cluster-randomized trial, consisting of multiple components including the possibility of active meetings. Analyses were based on the 173 participants in the intervention group. Feasibility was evaluated by questionnaire and interview data from participants, ambassadors and leaders. Effectiveness was assessed as the change in objectively measured sitting time from baseline to 3 months follow-up. Regular standing meetings were implemented at all offices and were generally popular, as they were perceived as more effective and focused. In contrast, only a few walking meetings were completed, and these were generally associated with several barriers and perceived as ineffective. Participants who participated in standing meetings on a regular basis had 59 min less sitting per 8 h workday (95%CI −101;−17) compared to participants who did not participate in standing meetings at all. Walking meeting participation was not significantly associated with changes in sitting time, likely due to the low number of employees who used this option. This explorative study concludes that standing meetings in office workplaces were feasible and well-liked by the employees, and having frequent standing meetings was associated with reduced sitting time. In contrast, walking meetings were unfeasible and less liked, and thus had no effect on sitting time.

scholarly journals Design and analysis of a 2-year parallel follow-up of repeated ivermectin mass drug administrations for control of malaria: Small sample considerations for cluster-randomized trials with count data

2021 ◽  
pp. 174077452110285
Author(s):  
Conner L Jackson ◽  
Kathryn Colborn ◽  
Dexiang Gao ◽  
Sangeeta Rao ◽  
Hannah C Slater ◽  
...  
Keyword(s):  
Randomized Trial ◽  
Cluster Randomized Trial ◽  
Mixed Effects ◽  
Small Sample ◽  
Mixed Effects Models ◽  
Type I ◽  
Cluster Randomized ◽  
Cluster Level ◽  
Generalized Estimating

Background: Cluster-randomized trials allow for the evaluation of a community-level or group-/cluster-level intervention. For studies that require a cluster-randomized trial design to evaluate cluster-level interventions aimed at controlling vector-borne diseases, it may be difficult to assess a large number of clusters while performing the additional work needed to monitor participants, vectors, and environmental factors associated with the disease. One such example of a cluster-randomized trial with few clusters was the “efficacy and risk of harms of repeated ivermectin mass drug administrations for control of malaria” trial. Although previous work has provided recommendations for analyzing trials like repeated ivermectin mass drug administrations for control of malaria, additional evaluation of the multiple approaches for analysis is needed for study designs with count outcomes. Methods: Using a simulation study, we applied three analysis frameworks to three cluster-randomized trial designs (single-year, 2-year parallel, and 2-year crossover) in the context of a 2-year parallel follow-up of repeated ivermectin mass drug administrations for control of malaria. Mixed-effects models, generalized estimating equations, and cluster-level analyses were evaluated. Additional 2-year parallel designs with different numbers of clusters and different cluster correlations were also explored. Results: Mixed-effects models with a small sample correction and unweighted cluster-level summaries yielded both high power and control of the Type I error rate. Generalized estimating equation approaches that utilized small sample corrections controlled the Type I error rate but did not confer greater power when compared to a mixed model approach with small sample correction. The crossover design generally yielded higher power relative to the parallel equivalent. Differences in power between analysis methods became less pronounced as the number of clusters increased. The strength of within-cluster correlation impacted the relative differences in power. Conclusion: Regardless of study design, cluster-level analyses as well as individual-level analyses like mixed-effects models or generalized estimating equations with small sample size corrections can both provide reliable results in small cluster settings. For 2-year parallel follow-up of repeated ivermectin mass drug administrations for control of malaria, we recommend a mixed-effects model with a pseudo-likelihood approximation method and Kenward–Roger correction. Similarly designed studies with small sample sizes and count outcomes should consider adjustments for small sample sizes when using a mixed-effects model or generalized estimating equation for analysis. Although the 2-year parallel follow-up of repeated ivermectin mass drug administrations for control of malaria is already underway as a parallel trial, applying the simulation parameters to a crossover design yielded improved power, suggesting that crossover designs may be valuable in settings where the number of available clusters is limited. Finally, the sensitivity of the analysis approach to the strength of within-cluster correlation should be carefully considered when selecting the primary analysis for a cluster-randomized trial.

Abstract P494: Long-term Outcomes of a Cluster-randomized Trial Testing the Effects Blood Pressure Telemonitoring and Pharmacist Management

Hypertension ◽  
2017 ◽  
Vol 70 (suppl_1) ◽  
Author(s):  
Karen L Margolis ◽  
Stephen E Asche ◽  
Anna R Bergdall ◽  
Steven P Dehmer ◽  
Beverly B Green ◽  
...  
Keyword(s):  
Blood Pressure ◽  
Randomized Trial ◽  
Clinical Care ◽  
Cluster Randomized Trial ◽  
Home Blood Pressure ◽  
Uncontrolled Hypertension ◽  
Routine Clinical Care ◽  
Differential Reduction ◽  
Cluster Randomized

Background/Aims: Hypertension is a common condition and leading cause of cardiovascular disease. We previously reported results of a cluster-randomized trial evaluating a home blood pressure (BP) telemonitoring and pharmacist management intervention, with significant reductions in BP favoring the intervention arm over 18 months. This analysis examined the durability of the intervention effect on BP through 54 months of follow-up and compared BP measurements performed in the research clinic and in routine clinical care. Methods: The Hyperlink trial randomized 16 primary care clinics having 450 study-enrolled patients with uncontrolled hypertension to either Telemonitoring Intervention (TI) or usual care (UC) study arms. BP was measured as the mean of 3 measurements obtained at each research clinic visit. General linear mixed models utilizing a direct likelihood-based ignorable approach for missing data were used to examine change from baseline to 54 months in systolic and diastolic BP (SBP and DBP). Results: Research clinic BP measurements were obtained from 326 (72%) study patients at the 54 month follow-up visit. Routine clinical care BP measurements were obtained from 444 (99%) of study patients from 7025 visits during the follow-up period. For TI patients, based on research clinic measurements baseline SBP was 148.2 mm Hg and 54 month follow-up was 131.2 mm Hg (-17.0 mm Hg, p<.001). For UC patients, baseline SBP was 147.7 mm Hg and 54 month follow-up was 131.7 mm Hg ( -16.0 mm Hg, p<.001). The differential reduction by study arm in SBP from baseline to 54 months was -1.0 mm Hg (95% CI: -5.4 to 3.4, p=0.63). For TI patients, baseline DBP was 84.4 mm Hg and 54 month follow-up was 77.8 (-6.6 mm Hg, p<.001). For UC patients, baseline DBP was 85.1 mm Hg and 54 month follow-up was 79.1 mm Hg (-6.0 mm Hg, p<.001). The differential reduction by study arm in DBP from baseline to 54 months was -0.6 mm Hg (95% CI: -3.5 to 2.4, p=0.67). SBP and DBP results from routine clinical measurements closely approximated the pattern of results from research clinic measurements. Conclusion: Significant BP reductions in the TI arm relative to UC were no longer seen at 54 month follow-up. To maintain intervention benefits over a longer period of time additional intervention is needed.

scholarly journals One-year follow-up of Atraumatic Restorative Treatment(ART) for dental caries in children undergoing oncohematological treatment: a pragmatic trial

2015 ◽  
Vol 15 (1) ◽  
Author(s):  
Cíntia Ferreira Gonçalves ◽  
Mariana Vargas Lindemaier e Silva ◽  
Luciane Rezende Costa ◽  
Orlando Ayrton de Toledo
Keyword(s):  
Dental Caries ◽  
Pragmatic Trial ◽  
Atraumatic Restorative Treatment ◽  
Restorative Treatment ◽  
One Year

Evaluation of a social media campaign to increase COVID-19 testing in migrant groups: A cluster randomized trial (Preprint)

2021 ◽  
Author(s):  
Ingeborg Hess Elgersma ◽  
Atle Fretheim ◽  
Thor Indseth ◽  
Anita Thorolvsen Munch ◽  
Live Bøe Johannessen ◽  
...  
Keyword(s):  
Social Media ◽  
Intervention Group ◽  
Cluster Randomized Trial ◽  
Control Group ◽  
Media Campaign ◽  
Predicted Probability ◽  
Simple Language ◽  
Media Intervention ◽  
Cluster Randomized ◽  
Migrant Groups

BACKGROUND A low test positivity rate is key to keeping the COVID-19 pandemic under control. Several migrant groups in Norway have seen higher rates of confirmed COVID-19 and related hospitalizations, while test positivity has remained high in the same groups. Social media sponsored ads have been an important part of the government’s strategy to reach these groups. OBJECTIVE In this study we aimed to investigate whether such a targeted Facebook campaign increased the rate of testing in certain migrant groups. METHODS We randomly assigned 386 Norwegian municipalities and city districts, to intervention or control groups. Individuals born in Syria, Pakistan, Eritrea, Turkey, Russia and Iraq residing in intervention areas were targeted with a social media campaign aiming at increasing the COVID-19 test rate. The campaign message was in simple language and conveyed in the users’ main language or in English. RESULTS During the follow-up period of two weeks, the predicted probability of conducting a COVID-19 test was 4.82 % (CI: 4.47 % - 5.18 %) in the control group, and 5.58 % (CI: 5.20 % - 5.99 %) in the intervention group (P=.004). CONCLUSIONS Our targeted social media intervention led to a modest, but potentially important, increase in test rates among migrants in Norway. CLINICALTRIAL ClinicalTrials.gov Identifier NCT04866589.

The Effect of Theory-lead Intervention for Knee Osteoarthritis in Older Adults: A Cluster Randomized Trial

2020 ◽  
Author(s):  
Limin Wang ◽  
Hongbo Chen ◽  
Han Lu ◽  
Yunlin Wang ◽  
Congying Liu ◽  
...  
Keyword(s):  
Older Adults ◽  
Knee Osteoarthritis ◽  
Transtheoretical Model ◽  
Intervention Group ◽  
Exercise Program ◽  
Exercise Adherence ◽  
Cluster Randomized Trial ◽  
Knee Function ◽  
Control Group ◽  
Cluster Randomized

Abstract Background: Knee osteoarthritis (KOA) is a common joint disease in people over 60 years old. Exercise therapy is one of the most effective non-pharmacological treatments for KOA, but low exercise adherence needs to be improved. The present study aimed to evaluate the effect of the transtheoretical model-lead home exercise intervention (TTM-HEI) program on exercise adherence, KOA symptoms and knee function in older adults with KOA. Methods: A two-arm, superiority, assessor-blinded, cluster randomized trial was conducted. Community-dwelling older adults with KOA were recruited from 14 community centers in Beijing, China via print and social media advertisements from April to October 2018. The intervention was a two-stage and 24-week transtheoretical model-based exercise program, and the control group underwent a same length but non-theory-based exercise program. Exercise adherence was measured by an 11-point numerical self-rating scale at weeks 4, 12, 24, 36, and 48 after the program started. KOA symptoms (pain intensity and joint stiffness) and knee function (lower limb muscle strength and balance) were measured at baseline, week 24, and week 48. Latent growth model (GLM), repeated measures ANOVA and independent t-test were the main statistical tests.Results: A total of 189 older adults (intervention group: n = 103, control group: n = 86) were enrolled. Differences of any outcome measures at baseline were not significant between groups. The growth rate of exercise adherence in the intervention group increased 2.175 units compared with the control group (unstandardized coefficient of slope on group B2 = 2.175, p < 0.001), and the intervention program maintained participants’ exercise adherence with 5.56 (SD = 1.00) compared with 3.16 (SD = 1.31) in the control group at week 48. In addition, TTM-HEI program showed significant effects on relieving KOA symptoms and improving knee function.Conclusion: The TTM-HEI could improve the participants’ exercise adherence, knee osteoarthritis symptoms and knee function over time.

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