scholarly journals Trial Characteristics and Appropriateness of Statistical Methods Applied for Design and Analysis of Randomized School-Based Studies Addressing Weight-Related Issues: A Literature Review

2018 ◽  
Vol 2018 ◽  
pp. 1-7 ◽  
Author(s):  
Moonseong Heo ◽  
Singh R. Nair ◽  
Judith Wylie-Rosett ◽  
Myles S. Faith ◽  
Angelo Pietrobelli ◽  
...  
Keyword(s):  
Power Analysis ◽  
Multilevel Models ◽  
Intracluster Correlation ◽  
The Past ◽  
School Based ◽  
Study Characteristics ◽  
Larger Sample ◽  
Cluster Level ◽  
Future School

Objective. To evaluate whether clustering effects, often quantified by the intracluster correlation coefficient (ICC), were appropriately accounted for in design and analysis of school-based trials. Methods. We searched PubMed and extracted variables concerning study characteristics, power analysis, ICC use for power analysis, applied statistical models, and the report of the ICC estimated from the observed data. Results. N=263 papers were identified, and N=121 papers were included for evaluation. Overall, only a minority (21.5%) of studies incorporated ICC values for power analysis, fewer studies (8.3%) reported the estimated ICC, and 68.6% of studies applied appropriate multilevel models. A greater proportion of studies applied the appropriate models during the past five years (2013–2017) compared to the prior years (74.1% versus 63.5%, p=0.176). Significantly associated with application of appropriate models were a larger number of schools (p=0.030), a larger sample size (p=0.002), longer follow-up (p=0.014), and randomization at a cluster level (p<0.001) and so were studies that incorporated the ICC into power analysis (p=0.016) and reported the estimated ICC (p=0.030). Conclusion. Although application of appropriate models has increased over the years, consideration of clustering effects in power analysis has been inadequate, as has report of estimated ICC. To increase rigor, future school-based trials should address these issues at both the design and analysis stages.

What Does Evidence-Based Practice Mean to You? A Follow-Up Study Examining School-Based Speech-Language Pathologists' Perspectives on Evidence-Based Practice

2020 ◽  
Vol 29 (2) ◽  
pp. 688-704
Author(s):  
Katrina Fulcher-Rood ◽  
Anny Castilla-Earls ◽  
Jeff Higginbotham
Keyword(s):  
Clinical Practice ◽  
Research Evidence ◽  
Evidence Based Practice ◽  
Evidence Based ◽  
Clinical Expertise ◽  
Speech Language Pathologists ◽  
School Based ◽  
Research Findings ◽  
Ebp Implementation

Purpose The current investigation is a follow-up from a previous study examining child language diagnostic decision making in school-based speech-language pathologists (SLPs). The purpose of this study was to examine the SLPs' perspectives regarding the use of evidence-based practice (EBP) in their clinical work. Method Semistructured phone interviews were conducted with 25 school-based SLPs who previously participated in an earlier study by Fulcher-Rood et al. 2018). SLPs were asked questions regarding their definition of EBP, the value of research evidence, contexts in which they implement scientific literature in clinical practice, and the barriers to implementing EBP. Results SLPs' definitions of EBP differed from current definitions, in that SLPs only included the use of research findings. SLPs seem to discuss EBP as it relates to treatment and not assessment. Reported barriers to EBP implementation were insufficient time, limited funding, and restrictions from their employment setting. SLPs found it difficult to translate research findings to clinical practice. SLPs implemented external research evidence when they did not have enough clinical expertise regarding a specific client or when they needed scientific evidence to support a strategy they used. Conclusions SLPs appear to use EBP for specific reasons and not for every clinical decision they make. In addition, SLPs rely on EBP for treatment decisions and not for assessment decisions. Educational systems potentially present other challenges that need to be considered for EBP implementation. Considerations for implementation science and the research-to-practice gap are discussed.

Facilitating Parental Involvement in Speech Therapy for Children With Speech Sound Disorders: A Survey of Speech-Language Pathologists' Practices, Perspectives, and Strategies

2020 ◽  
Vol 29 (4) ◽  
pp. 1987-1996
Author(s):  
Sherine R. Tambyraja
Keyword(s):  
Parental Involvement ◽  
Online Survey ◽  
Speech Therapy ◽  
Speech Sound ◽  
Speech Sound Disorders ◽  
Speech Sound Disorder ◽  
Speech Language Pathologists ◽  
School Based ◽  
Homework Completion

Purpose This study investigated the extent to which speech-language pathologists (SLPs) facilitate parents' completion of homework activities for children with speech sound disorder (SSD). In addition, this study explored factors related to more consistent communication about homework completion and strategies considered particularly effective for supporting this element of parental involvement. Method Licensed SLPs serving at least one child with SSD were invited to participate in an online survey. Questions relevant to this study gathered information regarding (a) frequency of communication about homework distribution and follow-up, (b) demographic and workplace characteristics, and (c) an open-ended question about the specific strategies used to support parental involvement and completion of homework activities. Results Descriptive results indicated considerable variability with respect to how frequently SLPs engaged in communication about homework completion, but that school-based SLPs were significantly less likely to engage in this type of follow-up. Strategies considered effective, however, were similar across therapy contexts. Conclusion These results suggest potentially important differences between school-based services and therapy in other contexts with respect to this particular aspect of service provision for children with SSD.

Socio-economic differences in smoking among adolescents in a school-based smoking intervention: The X:IT II study

2021 ◽  
pp. 140349482110076
Author(s):  
Lotus S. Bast ◽  
Lisbeth Lund ◽  
Stine G. LauemØller ◽  
Simone G. Kjeld ◽  
Pernille Due ◽  
...  
Keyword(s):  
Preventive Intervention ◽  
First Year ◽  
Difference In Difference ◽  
Current Smoking ◽  
Smoking Intervention ◽  
School Time ◽  
School Based ◽  
Inequality In Health ◽  
Baseline Response

Aims: Socio-economic inequalities in health behaviour may be influenced by health interventions. We examined whether the X:IT II intervention, aiming at preventing smoking in adolescence, was equally effective among students from different occupational social classes (OSC). Methods: We used data from the multi-component school-based smoking preventive intervention X:IT II, targeting 13- to 15-year-olds in Denmark. The intervention was tested in 46 schools with 2307 eligible students at baseline (response rate=86.6%) and had three main intervention components: smoke-free school time, smoke-free curriculum and parental involvement. We used a difference-in-difference design and estimated the change in current smoking after the first year of implementation in high versus low OSC. Analyses were based on available cases ( N=1190) and imputation of missing data at follow-up ( N=1967). Results: We found that 1% of the students from high OSC and 4.9% from low OSC were smokers at baseline (imputed data), and 8.2% of the students from high OSC and 12.2% from low OSC were smokers at follow-up. Difference-in-difference estimates were close to zero, indicating no differential trajectory. Conclusions: As intended, the X:IT II intervention, designed to apply equally to students from all socio-economic groups, did not seem to create different trajectories in current smoking among adolescents in high and low socio-economic groups. To diminish social inequality in health, future studies should carefully consider the ability to affect all socio-economic groups equally, or even to appeal mainly to participants from lower socio-economic groups, as they are often the ones most in need of intervention.

Penile Lymphoepithelioma-Like Carcinoma: A Rare Case With PD-L1 Expression

2021 ◽  
pp. 106689692098834
Author(s):  
Raquel Machado-Neves ◽  
Bernardo Teixeira ◽  
Elsa Fonseca ◽  
Pedro Valente ◽  
Joaquim Lindoro ◽  
...  
Keyword(s):  
Human Papillomavirus ◽  
Tumor Cells ◽  
Rare Case ◽  
Malignant Tumors ◽  
Squamous Cell Carcinomas ◽  
The Third ◽  
The Past ◽  
First Case ◽  
Lymphoplasmacytic Infiltrate

Most malignant tumors of the penis are squamous cell carcinomas (SCC), being divided in 2 groups, one human papillomavirus (HPV)-related and another non-HPV-related, with lymphoepithelioma-like carcinoma (LELC) being one of the rarest HPV-related SCC. In this article, we report a case of a 50-year-old man who presented testicular swelling and pain for the past 3 months. A penile mass was identified, and the patient was submitted to a total penectomy. The penectomy specimen showed an ulcerated lesion at the glans reaching the cavernous bodies. Microscopic examination showed undifferentiated epithelial cells with syncytial growth pattern mix with a dense lymphoplasmacytic infiltrate, consistent with LELC. The tumor cells expressed p16 and all 3 different clones of PDL1 (22C3, SP263, and SP142). The patient is alive and well with a follow-up of 3 months. To our knowledge, this is the third LELC of the penis reported in literature and the first case reported with PDL1 expression.

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.

scholarly journals O21 The incidence of COVID-19 among children with rheumatic diseases receiving biological agents

Rheumatology ◽  
2021 ◽  
Vol 60 (Supplement_1) ◽  
Author(s):  
Nadezhda Tsurikova ◽  
Elena Ligostaeva ◽  
Vadim Avdeenko ◽  
Nataliya Kobzeva ◽  
Irina Tsiganok ◽  
...  
Keyword(s):  
Rheumatic Diseases ◽  
Lupus Erythematosus ◽  
Biological Agents ◽  
Tnf Receptor ◽  
The Past ◽  
Different Types ◽  
Mediterranean Fever ◽  
Positive Results ◽  
Single Center Observational Study

Abstract Background/Aims  During the COVID-19 pandemic, analysis of the incidence of COVID-19 among patients suffering from rheumatic diseases and receiving therapy with biological agents remains relevant. Methods  This single-center observational study included 118 children suffering from various rheumatic diseases and receiving therapy with anti-rheumatic drugs and biological agents. In this research, we analyzed the incidence of CIVID-19 and the frequency of documented contact with SARS-CoV-2 in the period from 01.03.2020 to 11.10.2020 (32 weeks). The results were analyzed using descriptive statistics. Results  Among 118 children, there were 28 (24%) boys and 90 (76%) girls, average age 10.3±4.2. 104 (88.2%) patients had different types of juvenile idiopathic arthritis (JIA), 2 (1.6%) children had systemic lupus erythematosus (SLE), 2 (1.6%) patients had juvenile dermatomyositis (JDM), 1 (1%) child had ANCA-associated vasculitis, 6 (5%) patients had familial Mediterranean fever (FMF), 2 (1.6%) children had deficiency of adenosine deaminase 2 (DADA2), 1 (1%) child had TNF receptor-associated periodic syndrome (TRAPS). In this group of patients 94 (79%) patients were treated with methotrexate, 1 (1%) - azathioprine, 3 (2%) patients received hydroxychloroquine, 6(5%) - mycophenolate mofetil, 4 (3%) - sulfasalazine, 14(11%) children received prednisone, 6(5%) - cyclosporine A. All children included in this study received biological agents for more than 1 year, the distribution of biological agents among patients was as follows: 41(34%) - etanercept, 33(28%) - adalimumab, 24 (20%) - tocilizumab, 7 (6%) - canakinumab, 3 (2%) - abatacept, 4 (3%) - golimumab, 6 (5%) - rituximab. Out of 118 children, 4 (3%) patients had flu-like symptoms and positive results of PCR tests for COVID-19 (1 patient was treated with etanercept, 1 - adalimumab, 1 - tocilizumab, 1 - rituximab), none of the patients had signs of SARS-CoV-2 pneumonia. 10 (8%) patients had documented contact with COVID-19: among this patients 2 children had flu-like symptoms, positive results of PCR tests and absence of COVID-19 pneumonia (one of this patient was treated with adalimumab, another one - with rituximab), one more patient was treated with tocilizumab and had positive PCR test without any symptoms of COVID-19; other 7 children had negative PCR tests and didn’t have any signs of COVID-19. Conclusion  Among our patients with various rheumatic diseases treated with biological agents there were no registered severe cases of COVID-19. Over the past period (32 weeks of follow-up) 3% of children with COVID-19 were identified and 8% patients had documented contact with COVID-19, but we suppose it is too early to make conclusions about the degree and severity of COVID-19 among children suffering from rheumatic diseases and receiving various biological agents. Further follow-up is needed to better understand the risk and impact of COVID-19 among children with rheumatic diseases and receiving therapy with biological agents. Disclosure  N. Tsurikova: None. E. Ligostaeva: None. V. Avdeenko: None. N. Kobzeva: None. I. Tsiganok: None. K. Skorobogatova: None. A. Motkina: None.

scholarly journals 797. Management of Patients with Multiple Clostridioides difficile Infection Recurrences using a Tapered-Pulsed Fidaxomicin Strategy

2020 ◽  
Vol 7 (Supplement_1) ◽  
pp. S441-S442
Author(s):  
Xing Tan ◽  
Andrew M Skinner ◽  
Benjamin Sirbu ◽  
Larry H Danziger ◽  
Dale N Gerding ◽  
...  
Keyword(s):  
First Episode ◽  
Initial Symptom ◽  
Once Daily ◽  
The Past ◽  
Clostridioides Difficile ◽  
Time To Recurrence ◽  
Clostridioides Difficile Infection ◽  
The Mean ◽  
Systemic Antibiotics

Abstract Background There is a paucity of data assessing outcomes of alternate fidaxomicin strategies in patients with recurrent Clostridioides difficile infection (rCDI). The objective of our study is to evaluate a tapered-pulsed (T-P) fidaxomicin regimen that was administered immediately following a course of CDI treatment with initial symptom resolution in patients with multiple rCDI. Methods We reviewed the characteristics and outcomes of 46 consecutive patients who received T-P fidaxomicin between January 1, 2014-June 30, 2019 in a specialty CDI clinic. The first episode in which fidaxomicin T-P was administered was analyzed. Failure was defined as the persistence of diarrhea and/or the need for additional CDI treatment at any time on T-P fidaxomicin. Sustained clinical cure (SCC) was defined as resolution of diarrhea without recurrence. Recurrence was defined as the return of diarrhea requiring retreatment with CDI therapy after completion of T-P fidaxomicin. Both SCC and recurrence were evaluated at 30 and 90 days after completion of T-P fidaxomicin. Results The mean±SD age of the 46 patients was 63.2±19.9 years, 71.7% were female, and the mean±SD CDI episodes within the past year was 3±1.4 . Most patients (73.9%) had previously failed a vancomycin tapered and/or pulsed regimen. Prior to administering T-P fidaxomicin, a treatment regimen was given to ensure resolution of symptoms. The CDI treatment most commonly used (58.7%) was vancomycin. The T-P fidaxomicin regimen used consisted of 200 mg given once daily for 7 days followed by 200 mg every other day for a median (min-max) duration of 33 (6-120) days. Two patients (4%) failed to respond to T-P fidaxomicin; 34 (74%) and 28 (61%) achieved SCC at 30 and 90 days, respectively. Among the 44 patients that successfully completed the T-P fidaxomicin regimen, recurrence developed in 10 (22.7%) and 16 (36.4%) of patients at 30 and 90 days, respectively, with a median (min-max) time to recurrence of 20 (3-87) days (Figure 1). Four patients with recurrence had received subsequent systemic antibiotics. Figure 1. Course of CDI therapy and follow-up Conclusion A tapered-pulsed fidaxomicin strategy may be effective in patients with multiply rCDI who are refractory to other treatments, including a vancomycin tapered and pulsed regimen. Disclosures Larry H. Danziger, PharmD, Merck (Speaker’s Bureau)

Outcome of thoracolumbar surgical feline intervertebral disc disease

2021 ◽  
pp. 1098612X2110280
Author(s):  
Kayla M Fowler ◽  
Theresa E Pancotto ◽  
Stephen R Werre ◽  
Michaela J Beasley ◽  
William Kay ◽  
...  
Keyword(s):  
Clinical Outcome ◽  
Intervertebral Disc ◽  
Positive Outcome ◽  
Intervertebral Disc Herniation ◽  
Intervertebral Disc Disease ◽  
Disc Disease ◽  
Exact Test ◽  
Imaging Results ◽  
Larger Sample

Objectives The aim of this study was to evaluate the outcome and prognosis of thoracolumbar feline intervertebral disc disease (IVDD) treated by surgical decompression. Methods This was a multi-institutional retrospective study evaluating the age, breed, sex, body weight, presenting complaint, neuroanatomic diagnosis at presentation, diagnostic imaging results, surgery performed and the overall outcome at discharge and at recheck. Bivariable associations between variables were assessed using the Kruskal–Wallis test (age and grade of IVDD at presentation) and Fisher’s exact test (grade of IVDD at presentation and outcome). Results A total of 35 cats met the inclusion criteria for the study. The most frequently reported clinical sign was difficulty walking (54.2%). The majority of cats presented with an L4–S3 localization (57%). The most common site of intervertebral disc herniation (IVDH) was at L6–L7 (34%). The majority of feline patients that received surgery had a positive outcome at the time of discharge (62.5%; n = 20/32) and at the time of the 2-week recheck (91.3%; n = 21/23). No association was identified between the age of the patient and the grade of IVDD. No association was identified between the presenting grade of IVDD and the clinical outcome at the time of discharge or at the time of recheck evaluation. Conclusions and relevance Cats undergoing spinal decompressive surgery for thoracolumbar IVDH appear to have a favorable prognosis independent of the initial presenting grade of IVDD. A larger sample size and a longer length of follow-up is necessary to obtain statistical associations between the presenting grade of IVDD and overall clinical outcome.

Reward-Related Attentional Capture Moderates the Association between Fear-Driven Motives and Heavy Drinking

2021 ◽  
pp. 1-11
Author(s):  
Chang Liu ◽  
Murat Yücel ◽  
Chao Suo ◽  
Mike E. Le Pelley ◽  
Jeggan Tiego ◽  
...  
Keyword(s):  
Alcohol Consumption ◽  
Attentional Capture ◽  
Heavy Drinking ◽  
Drinking Motives ◽  
Drinking Patterns ◽  
Cognitive Mechanisms ◽  
Problematic Drinking ◽  
The Past ◽  
Motivational Profile

Background: To date, there has been little investigation on how motivational and cognitive mechanisms interact to influence problematic drinking behaviours. Towards this aim, the current study examined whether reward-related attentional capture is associated with reward, fear (relief), and habit drinking motives, and further, whether it interacts with these motives in relation to problematic drinking patterns. Methods: Ninety participants (mean age = 34.8 years, SD = 9.1, 54% male) who reported having consumed alcohol in the past month completed an online visual search task that measured reward-related attentional capture as well as the Habit Reward Fear Scale, a measure of drinking motives. Participants also completed measures of psychological distress, impulsivity, compulsive drinking, and consumption items of Alcohol Use Disorders Identification Test. Regression analyses examined the associations between motives for alcohol consumption and reward-related attentional capture, as well as the associations between reward-related attentional capture, motives, and their interaction, with alcohol consumption and problems. Results: Greater reward-related attentional capture was associated with greater reward motives. Further, reward-related attentional capture also interacted with fear motives in relation to alcohol consumption. Follow-up analyses showed that this interaction was driven by greater fear motives being associated with heavier drinking among those with lower reward-related attentional capture (i.e., “goal-trackers”). Conclusion: These findings have implications for understanding how cognition may interact with motives in association with problematic drinking. Specifically, the findings highlight different potential pathways to problematic drinking according to an individual’s cognitive-motivational profile and may inform tailored interventions to target profile-specific mechanisms. Finally, these findings offer support for contemporary models of addiction that view excessive goal-directed behaviour under negative affect as a critical contributor to addictive behaviours.

Sign in / Sign up

Export Citation Format

Share Document