Negligible Therapeutic Impact, False-positives, Overdiagnosis and Lead-time Are the Reasons Why Radiographs Bring More Harm Than Benefits in the Caries Diagnosis of Preschool Children: Secondary Analysis of a Randomized Clinical Trial 

2020 ◽  
Author(s):  
Laura Regina Antunes Pontes ◽  
Juan Sebastian Lara ◽  
Tatiane Fernandes Novaes ◽  
Julia Gomes Freitas ◽  
Thais Gimenez ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Preschool Children ◽  
Lead Time ◽  
Visual Inspection ◽  
Secondary Analysis ◽  
Caries Detection ◽  
Diagnostic Strategy ◽  
Radiographic Assessment ◽  
Deciduous Molars

Abstract Background: To evaluate the clinical course and interventions required during two years of follow-up of dental surfaces of deciduous molars diagnosed, and consequently treated, by two different strategies: diagnosis made by clinical examination alone or associated with radiographs.Methods: This is a secondary analysis of a two-arm randomized clinical trial with two parallel groups related to the diagnostic strategy for caries detection in preschool children. 216 children (3 to 6 years old) were followed-up for two years. All dental surfaces were diagnosed by visual inspection and later, through radiographic assessment. Baseline treatment was made in accordance with the results obtained by visual inspection performed alone or combined with radiographic method, considering the allocated group. Dental surfaces with no restoration needs, or those restored at the beginning of the study were followed-up for two years. The treatment decision was made according to the allocated group. The outcome was the occurrence of failure (a new caries lesion or a restoration replacement) during the follow-up. Results: 4,383 proximal and occlusal surfaces of deciduous molars in 216 preschool children were diagnosed and treated according to the abovementioned diagnostic strategies and followed-up for 24 months. The assessment of radiographs made change the initial decision reached by visual inspection in about 30% of the surfaces when all types of interventions were considered. However, most disagreements occurred for initial lesions, where radiographs tended to underestimate them. Discordances between methods occurred in less than 5% of all surfaces when considered lesions requiring operative treatment. For discrepancy cases, the placed interventions guided by following the radiographic results did not present less failures against those made following only visual inspection. As a matter of fact, the use of radiographs in the diagnostic strategy for caries detection in children brought more harms than benefits due to the occurrence of false-positives, overdiagnosis and lead-time bias.Conclusions: Simultaneous association of visual inspection and radiographic assessment for caries detection in preschool children causes more harms than benefits, and therefore, visual inspection should be conducted alone in the regular clinical practice.Trial registration: clinicaltrials.gov platform: NCT02078453, registered on 5th March 2014

scholarly journals Negligible therapeutic impact, false-positives, overdiagnosis and lead-time are the reasons why radiographs bring more harm than benefits in the caries diagnosis of preschool children

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Laura Regina A. Pontes ◽  
◽  
Juan Sebastian Lara ◽  
Tatiane Fernandes Novaes ◽  
Julia Gomes Freitas ◽  
...  
Keyword(s):  
Preschool Children ◽  
Lead Time ◽  
Visual Inspection ◽  
False Positives ◽  
Caries Detection ◽  
Diagnostic Strategy ◽  
Radiographic Assessment ◽  
Occlusal Surfaces ◽  
Deciduous Molars

Abstract Background To evaluate the clinical course and interventions required during two years of follow-up of dental surfaces of deciduous molars diagnosed, and consequently treated, by two different strategies: diagnosis made by clinical examination alone or associated with radiographs. Methods This is a secondary analysis of a two-arm randomized clinical trial with parallel groups related to the diagnostic strategy for caries detection in preschool children. 216 children (3–6 years old) were followed-up for two years. All dental surfaces were diagnosed by visual inspection and later, through radiographic assessment. Baseline treatment was made in accordance with the results obtained by visual inspection performed alone or combined with radiographic method, considering the allocated group. Dental surfaces with no restoration needs, or those restored at the beginning of the study were followed-up for two years. The treatment decision was made according to the allocated group. The outcome was the occurrence of failure (a new caries lesion or a restoration replacement) during the follow-up. Results 4383 proximal and occlusal surfaces of deciduous molars in 216 preschool children were diagnosed and treated according to the abovementioned diagnostic strategies and followed-up for 24 months. The assessment of radiographs made change the initial decision reached by visual inspection in about 30% of the surfaces when all types of interventions were considered. However, most disagreements occurred for initial lesions, where radiographs tended to underestimate them. Discordances between methods occurred in less than 5% of all surfaces when considered lesions requiring operative treatment. For discrepancy cases, the placed interventions guided by following the radiographic results did not present less failures against those made following only visual inspection. As a matter of fact, the use of radiographs in the diagnostic strategy for caries detection in children brought more harms than benefits due to the occurrence of false-positives, overdiagnosis and lead-time bias. Conclusions Simultaneous association of visual inspection and radiographic assessment for caries detection in preschool children causes more harms than benefits, and therefore, visual inspection should be conducted alone in the regular clinical practice. Trial registration Clinicaltrials.gov platform: NCT02078453, registered on 5th March 2014.

scholarly journals Association between smoking cessation and post-hospitalization healthcare costs: a matched cohort analysis

2019 ◽  
Vol 19 (1) ◽  
Author(s):  
Margaret B. Nolan ◽  
Bijan J. Borah ◽  
James P. Moriarty ◽  
David O. Warner
Keyword(s):  
Clinical Trial ◽  
Hospital Discharge ◽  
Healthcare Costs ◽  
Smoking Status ◽  
Cohort Analysis ◽  
Secondary Analysis ◽  
Population Based ◽  
Point Prevalence ◽  
Point Prevalence Abstinence

Abstract Background The potential economic benefit in terms of reduced healthcare costs when patients quit smoking after hospital discharge has not been directly measured. The aim of this study was to compare the costs for hospital admission and six-month follow-up for a cohort of patients who self-reported abstinence from cigarettes at 6 months after hospital discharge and a matched group of patients who reported continued smoking. Materials and methods This was a secondary analysis of a recent population-based clinical trial cohort (ClinicalTrials.gov ID: NCT01575145), with cohort membership determined by self-reported 7 day point prevalence abstinence at 6 months after the index hospital discharge. Participants were admitted to Mayo Clinic Hospital, Rochester, MN, between May 5, 2012 and August 10, 2014 for any indication and lived in the areas covered by postal codes included in Olmsted County, MN. Propensity score matching was used to control for differences between groups other than smoking status, and any residual imbalance was adjusted through generalized linear model with gamma distribution for cost and log-link transformation. Results Of 600 patients enrolled in the clinical trial, 144 could be contacted and self-reported 7 day point prevalence abstinence at 6 months after hospital discharge. Of these patients, 99 were successfully matched for this analysis. The cost for the index hospitalization was significantly greater in patients who abstained compared to those that did not abstain (mean difference of $3042, higher for abstainers, 95% CI $170 to $5913, P = 0.038). However, there was no difference between mean 6-month follow-up costs, number of inpatient hospitalizations, or number of emergency room visits for abstainers versus non-abstainers. Conclusion There was no evidence to support the hypothesis that abstinence at 6 months after hospital discharge is associated with a decrease in health care costs or utilization over the first 6 months after hospital discharge.

Impact of visual inspection and radiographs for caries detection in children through a 2-year randomized clinical trial

2020 ◽  
Vol 151 (6) ◽  
pp. 407-415.e1 ◽  
Author(s):  
Laura R.A. Pontes ◽  
Tatiane F. Novaes ◽  
Juan S. Lara ◽  
Thais Gimenez ◽  
Bruna L.P. Moro ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Randomized Clinical Trial ◽  
Visual Inspection ◽  
Caries Detection

scholarly journals Risk of keratinocyte carcinomas with vitamin D and calcium supplementation: a secondary analysis of a randomized clinical trial

2020 ◽  
Vol 112 (6) ◽  
pp. 1532-1539
Author(s):  
Michael N Passarelli ◽  
Margaret R Karagas ◽  
Leila A Mott ◽  
Judy R Rees ◽  
Elizabeth L Barry ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Vitamin D ◽  
Cell Carcinoma ◽  
Randomized Clinical Trial ◽  
Calcium Supplementation ◽  
Secondary Analysis ◽  
Colorectal Adenomas ◽  
Double Blind ◽  
Skin Cancers

ABSTRACT Background It is unknown whether dietary supplementation with vitamin D or calcium prevents keratinocyte carcinomas, also known as nonmelanoma skin cancers. Objectives This study aimed to determine whether daily vitamin D or calcium supplementation alters the risk of basal cell carcinoma (BCC) or invasive cutaneous squamous cell carcinoma (SCC). Methods The Vitamin D/Calcium Polyp Prevention Study is a completed multicenter, double-blind, placebo-controlled, partial 2 × 2 factorial, randomized clinical trial of vitamin D, calcium, or both for the prevention of colorectal adenomas. During 2004–2008, a total of 2259 men and women, 45–75 y of age, recently diagnosed with a colorectal adenoma, were randomly assigned to 1000 IU/d of vitamin D3 or placebo and 1200 mg/d of calcium carbonate or placebo for 3 or 5 y, and followed after treatment ended. Reports of incident BCC or SCC were confirmed from pathology records. Results During a median follow-up of 8 y, 200 (9%) participants were diagnosed with BCC and 68 (3%) participants were diagnosed with SCC. BCC incidence was unrelated to treatment with vitamin D compared with no vitamin D (HR: 0.96; 95% CI: 0.73, 1.26), calcium compared with no calcium (HR: 1.01; 95% CI: 0.74, 1.39), and both agents compared with neither (HR: 0.99; 95% CI: 0.65, 1.51). SCC incidence was unrelated to treatment with vitamin D compared with no vitamin D (HR: 0.79; 95% CI: 0.49, 1.27), but there was suggestive evidence of beneficial treatment effects for calcium compared with no calcium (HR: 0.60; 95% CI: 0.36, 1.01) and both agents compared with neither (HR: 0.42; 95% CI: 0.19, 0.91). Conclusions Calcium alone or in combination with vitamin D may reduce the risk of SCC, but not BCC. This trial was registered at clinicaltrials.gov as NCT00153816.

scholarly journals Neurodevelopmental status and follow-up in preschool children with heart disease in London, UK

2020 ◽  
pp. archdischild-2019-317824
Author(s):  
Aparna Hoskote ◽  
Deborah Ridout ◽  
Victoria Banks ◽  
Suzan Kakat ◽  
Monica Lakhanpaul ◽  
...  
Keyword(s):  
Heart Disease ◽  
Preschool Children ◽  
Child Development ◽  
Normal Development ◽  
Secondary Analysis ◽  
Clinical Event ◽  
Convenience Sample ◽  
Heart Operation ◽  
History Of

ObjectiveTo describe neurodevelopment and follow-up services in preschool children with heart disease (HD).DesignSecondary analysis of a prospectively collected multicentre dataset.SettingThree London tertiary cardiac centres.PatientsPreschool children<5 years of age: both inpatients and outpatients.MethodsWe analysed results of Mullen Scales of Early Learning (MSEL) and parental report of follow-up services in a representative convenience sample evaluated between January 2014 and July 2015 within a previous study.ResultsOf 971 preschool children: 577 (59.4%) had ≥1 heart operation, 236 (24.3%) had a known diagnosis linked to developmental delay (DD) (‘known group’) and 130 (13.4%) had history of clinical event linked to DD. On MSEL assessment, 643 (66.2%) had normal development, 181 (18.6%) had borderline scores and 147 (15.1%) had scores indicative of DD. Of 971 children, 609 (62.7%) were not receiving follow-up linked to child development and were more likely to be under these services with a known group diagnosis, history of clinical event linked to DD and DD (defined by MSEL). Of 236 in known group, parents of 77 (32.6%) and of 48 children not in a known group but with DD 29 (60.4%), reported no child development related follow-up. DD defined by MSEL assessment was more likely with a known group and older age at assessment.ConclusionsOur findings indicate that a ‘structured neurodevelopmental follow-up pathway’ in preschool children with HD should be considered for development and evaluation as children get older, with particular focus on those at higher risk.

Effectiveness of Resin-Based Sealants with and without Fluoride Placed in a High Caries Risk Population: Multicentric 2-Year Randomized Clinical Trial

2018 ◽  
Vol 52 (4) ◽  
pp. 312-322 ◽  
Author(s):  
Michèle Muller-Bolla ◽  
Fréderic Courson ◽  
Laurence Lupi-Pégurier ◽  
Corinne Tardieu ◽  
Shrisha Mohit ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Randomized Clinical Trial ◽  
Retention Rate ◽  
Intervention Group ◽  
Assessment System ◽  
Caries Detection ◽  
Control Group ◽  
Caries Risk ◽  
High Caries Risk

A split-mouth randomized clinical trial was carried out to assess the effectiveness of sealants in preventing carious ICDAS (International Caries Detection and Assessment System) 3–6 lesions within a 2-year follow-up. We evaluated the effectiveness of 2 types of resin-based sealants, with and without fluoride, their retention rates, and the caries risk factors related to their outcomes. The study included 663 tooth pairs in 400 children (aged 5–15 years) considered to be at high individual caries risk (ICR) and presenting permanent molars free of caries or affected by ICDAS 1–2 lesions. In the first randomization, molars were either randomized to the treatment group receiving a dental sealant or the control group (nontreatment), and in the second randomization the sealant material to be used in the intervention group was selected. Uni- and multivariate Cox proportional hazard models were employed. At the 2-year follow-up, 483 tooth pairs were assessed: sealed molars had 83% (adjusted HR = 0.17; 95% CI: 0.15–0.20) less risk of developing ICDAS 3–6 lesions than molars without sealant. The magnitude of the protective effect was lower among teeth with ICDAS 1–2 lesions or with occlusal deep fissures than without. If the total retention rate of sealants was 70% at 2 years, sealant loss was not associated with the risk of caries (HR = 1.29, 95% CI: 0.92–1.79, p = 0.14). Sealants allow the prevention of new ICDAS 3–6 lesions or progression of noncavitated carious lesions in children at high ICR, and the effect of the sealant was similar regardless of whether it contained fluoride or not.

Detection of early occlusal caries of the first permanent molar using different techniques (An in vivo study)

2019 ◽  
Vol 31 (1) ◽  
pp. 1-8
Author(s):  
Samah F. Al-Qazzaz ◽  
Abeer M. Hassan
Keyword(s):  
Sensitivity And Specificity ◽  
Visual Inspection ◽  
Caries Detection ◽  
Occlusal Caries ◽  
Clinical Sensitivity ◽  
Permanent Molar ◽  
Permanent Molars ◽  
Early Caries ◽  
First Permanent Molars ◽  
Better Than

Background: Molars and premolars are considered as the most vulnerable teeth of caries attack, which is related to the morphology of their occlusal surfaces along with the difficulty of plaque removal. different methods were used for early caries detection that provide sensitive, accurate preoperative diagnosis of caries depths to establish adequate preventive measures and avoid premature tooth treatment by restoration. The aim of the present study was to evaluate the clinical sensitivity and specificity rates of DIAGNOdent and visual inspection as opposed to the ICDAS for the detection of initial occlusal caries in noncavitated first permanent molars. Materials and Methods: This study examined 139 occlusal surface of the first permanent molar pooled from fifty patients aged 8-9 years by three methods. The selected criteria include one occlusal site per tooth (first permanent molars) with carious lesions range from 0 to 3 according to ICDASII (gold standard) visual criteria then the clinical sensitivity and specificity of visual inspection according to Ekstrand et al.in 1997 and DIAGNOdent were performed. . Results: the highest correlation was found between the ICDASII and DIAGNOdent. The sensitivity of the DIAGNOdent for the enamel caries detection (D1) was better than that of visual inspection. The sensitivity and the specificity for the DIAGNOdent at D3 threshold were better than the D1 threshold and the visual inspection method. Conclusion: DIAGNOden pen can be used as a tool for early caries detection in cases of difficult diagnosis that provide good additional sensitivity to the visual inspection.

The impact of increasing interbody fusion levels at the fractional curve on lordosis, curve correction, and complications in adult patients with scoliosis

2020 ◽  
pp. 1-10
Author(s):  
Dominic Amara ◽  
Praveen V. Mummaneni ◽  
Shane Burch ◽  
Vedat Deviren ◽  
Christopher P. Ames ◽  
...  
Keyword(s):  
Postoperative Complications ◽  
Revision Surgery ◽  
Lumbar Lordosis ◽  
Interbody Fusion ◽  
Pelvic Incidence ◽  
Secondary Analysis ◽  
Lumbar Interbody Fusion ◽  
Curve Correction ◽  
Surgery Rates

OBJECTIVERadiculopathy from the fractional curve, usually from L3 to S1, can create severe disability. However, treatment methods of the curve vary. The authors evaluated the effect of adding more levels of interbody fusion during treatment of the fractional curve.METHODSA single-institution retrospective review of adult patients treated for scoliosis between 2006 and 2016 was performed. Inclusion criteria were as follows: fractional curves from L3 to S1 > 10°, ipsilateral radicular symptoms concordant on the fractional curve concavity side, patients who underwent at least 1 interbody fusion at the level of the fractional curve, and a minimum 1-year follow-up. Primary outcomes included changes in fractional curve correction, lumbar lordosis change, pelvic incidence − lumbar lordosis mismatch change, scoliosis major curve correction, and rates of revision surgery and postoperative complications. Secondary analysis compared the same outcomes among patients undergoing posterior, anterior, and lateral approaches for their interbody fusion.RESULTSA total of 78 patients were included. There were no significant differences in age, sex, BMI, prior surgery, fractional curve degree, pelvic tilt, pelvic incidence, pelvic incidence − lumbar lordosis mismatch, sagittal vertical axis, coronal balance, scoliotic curve magnitude, proportion of patients undergoing an osteotomy, or average number of levels fused among the groups. The mean follow-up was 35.8 months (range 12–150 months). Patients undergoing more levels of interbody fusion had more fractional curve correction (7.4° vs 12.3° vs 12.1° for 1, 2, and 3 levels; p = 0.009); greater increase in lumbar lordosis (−1.8° vs 6.2° vs 13.7°, p = 0.003); and more scoliosis major curve correction (13.0° vs 13.7° vs 24.4°, p = 0.01). There were no statistically significant differences among the groups with regard to postoperative complications (overall rate 47.4%, p = 0.85) or need for revision surgery (overall rate 30.7%, p = 0.25). In the secondary analysis, patients undergoing anterior lumbar interbody fusion (ALIF) had a greater increase in lumbar lordosis (9.1° vs −0.87° for ALIF vs transforaminal lumbar interbody fusion [TLIF], p = 0.028), but also higher revision surgery rates unrelated to adjacent-segment pathology (25% vs 4.3%, p = 0.046). Higher ALIF revision surgery rates were driven by rod fracture in the majority (55%) of cases.CONCLUSIONSMore levels of interbody fusion resulted in increased lordosis, scoliosis curve correction, and fractional curve correction. However, additional levels of interbody fusion up to 3 levels did not result in more postoperative complications or morbidity. ALIF resulted in a greater lumbar lordosis increase than TLIF, but ALIF had higher revision surgery rates.

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