The implementation potential of a method to monitor empirically-supported children’s mental health treatment through claims data

Background The delivery of evidence-supported treatments (EST) in children’s mental health could be a valuable measure for monitoring mental healthcare quality; however, efforts to monitor the use of EST in real world systems are hindered by the lack of pragmatic methods. This mixed methods study examined the implementation and agency response rate of a pragmatic, claims-based measure of EST designed to be applied as a universal quality measure for child psychotherapy encounters in a state Medicaid system. Methods Implementation potential of the EST measure was assessed with healthcare leader rankings of the reporting method’s acceptability, appropriateness and feasibility (n = 53), and post-implementation ratings of EST rate accuracy. Ability of the healthcare system to monitor EST through claims was measured by examining the agency responsivity in using the claims-based measure across 98 Medicaid-contracted community mental health (CMH) agencies in Washington State. Results The analysis found the reporting method had high implementation potential. The method was able to measure the use of an EST for 83% of children covered by Medicaid with 58% CMH agencies reporting > 0 ESTs in one quarter. Qualitative analyses revealed that the most significant barrier to reporting ESTs was the operability of electronic health record systems and agencies’ mixed views regarding the accuracy and benefits of reporting. Conclusions Measurement of child mental health ESTs through Medicaid claims reporting has acceptable implementation potential and promising real world responsiveness from CMH agencies in one state. Variation in reporting by agency site and low to moderate perceived value by agency leaders suggests the need for additional implementation supports for wider uptake.

Health belief model factors as predictors of parental misclassification of the weight of the preschool child

Background Parental misperception and underestimation of their child’s weight are documented in studies. Demographic factors like age and gender have been linked to misclassification. However, modifiable factors that could potentially frame future intervention and prevention strategies have not been explored. This study aimed to assess factors that could predict parental misclassification of their preschool child’s weight. Methods This was a cross-sectional study with 198 parents and their 2- to 5-year-old children who attended standalone preschools or childcare centers with preschools. Parents completed a questionnaire that asked about demographic features, personal and family health, and the assessment of their child’s weight using the three most frequently utilized measures. Logistic regression was conducted to assess the association between parental factors and child weight classification status. Instruments included the Parental Self-Efficacy for Promoting Healthy Physical Activity and Dietary Behaviors in Children Scale (PSEPAD), the Obesity Risk Scale (ORK-10), and the Adolescent Obesity Risk Scale (AORK). Analyses included frequencies, chi-square tests, Kappa coefficients, and logistic regressions. Results Parents were least accurate (35.9%) identifying child weight when selecting a picture (κ = -.028, p = .42). The pictorial and Likert method (κ = -.032, p = .37) showed parental agreement with child weight was not significantly better than chance. Statistically, a significant agreement was found in the weight-reporting method (κ = .21). Two of the three HBM-related measures were significantly related to accurate classification. Logistic regression showed child sex, PSEPAD scores, and ORK-10 scores were statistically significant predictors in the Likert method. The model had no statistical significance for the pictorial or weight-reporting method. Conclusion Results indicate parents support intervening if aware of child weight problems. However, parents do not accurately recognize healthy versus unhealthy weights and report that health providers are not informing them of weight deviations. Further, important relationships between the HBM variables were identified. Results show barriers (self-efficacy) mediate the impact of perceived severity (knowledge) regarding the parental ability to assess child weight accurately. These relationships and incorporation of the HBM principles of barriers and severity into prevention/intervention strategies need further exploration.

Planning and Reporting Method Validation Studies Print Email. A Supplement to the Eurachem Guide «The Fitness for Purpose of Analytical Methods»

Ukrainian translation of The Fitness for Purpose of Analytical Methods - A Laboratory Guide to Method Validation and Related Topics (2nd ed.), which was published in 2014, is offered. Since Document publication the Method Validation Working Group has identified areas where extra guidance would be appropriate. This extra guidance has been prepared in the form of supplementary documents, which should be used in conjunction with the Guide. Original Document is published on the Euracem website. https://www.eurachem.org/index.php/publications/guides/planning-validation-studies

Evaluating longitudinal toxicity of cetuximab in patients with metastatic colorectal cancer (mCRC): A pooled analysis from 1,302 patients in the ARCAD database.

3610 Background: Chronic lower grade adverse events (AE) can negatively affect a patient’s quality of life but it is difficult to capture using a traditional toxicity reporting approach. A novel AE reporting method was recently developed to describe, summarize, and present longitudinal AE profiles(Lopes et al, 2021). We leveraged this method to describe and compare the AE profiles of doublet chemotherapy (DC) + Cetuximab and DC alone in mCRC patients. Methods: This AE reporting method utilizes two additional AE metrics to complement the maximum (max) toxicity grade usually reported in clinical trials. Onset time indicates the time period in which max grade for an AE occurred for the first time, defined here as “early” (i.e. within first 42 days) and “late” (i.e. after the 42nd day). AE Load (AEL) indicates the overall severity of an AE in the entire treatment. AEL varies from 0 to 1. Higher AEL indicates a worse overall severity of that AE over time. AEL is the key metric for describing chronic AE. We included patients receiving DC + cetuximab (n = 738) and DC alone (n = 564 [ref group]) from two randomized first-line trials in the ARCAD database. Diarrhea, rash, hand-foot syndrome (HFS), fatigue, anorexia, and mucositis were examined and adjusted for backbone (FOLFOX vs. FOLFIRI), ECOG PS, sex, site location, dose reduction, and treatment length. Results: For rash, DC + cetuximab had a higher risk of G3+ (21% vs. 0.5%; odds ratio {OR} [95% confidence interval {CI}] = 50 [16,157], p < 0.001), increased overall severity over the entire treatment (AEL = 0.257 vs. 0.069; Adjusted difference in means–Mdiff [95% CI] = 0.22 [0.21,0.23], p < 0.001), and increased risk of early onset (67% vs. 33%; OR [95% CI] = 4.3 [2.7,6.7], p < 0.001). DC + cetuximab also had higher AEL for rash across max grades (p < 0.001 within G1, G2, and G3+). For HFS, DC + cetuximab had a higher risk of G3+ (OR [95% CI] = 6.0 [2.5,14], p < 0.001), increased overall severity (AEL = 0.139 vs. 0.087; Mdiff [95% CI] = 0.03 [0.03,0.04], p < 0.001), and slightly earlier onset (12.4 vs. 13.9 weeks; Mdiff, weeks [95% CI] = -4.9 [-0.80,-9.0], p = 0.021). Within each max grade, DC + cetuximab did not have higher AEL of HFS. No associations were found for diarrhea, fatigue, anorexia, or mucositis. Conclusions: The addition of cetuximab is associated with higher grade, more persistent, and more immediate rash. The higher severity in HFS with the addition of cetuximab appears to be related to higher grade but not chronic HFS. This method may be useful to describe different strategies, e.g. intermittent cetuximab. It provided a comprehensive view of acute and chronic toxicity profiles supporting its potential interest as new metrics in clinical trials. Lopes GS, Tournigand C, Olswold CL, et al. Adverse event load, onset, and maximum grade: A novel method of reporting adverse events in cancer clinical trials. Clinical Trials. 2021;18(1):51-60

EVALUATION OF ADVERSE DRUG REACTIONS IN A TERTIARY CARE CENTER IN SOUTH INDIA-A PROSPECTIVE OBSERVATIONAL STUDY

Aim:To Evaluate the Adverse Drug Reactions among patients attending a tertiary care centre. Materials and Methods: Aprospective spontaneous reporting method of Adverse Drug Reaction (ADR) in hospitalised setting was conducted for a period of six months. Results: The study came across with the demography of patients, the most commonly involved classes of drugs and assessment of ADRs. The results showed that 136 adverse drug reactions were reported from a total of 11584 patients and the overall incidence of ADR calculated from patient population was 0.81%. No signicant difference was seen in overall incidence of ADRs observed in males and females. Incidence of ADRs among adults (1.15%) was signicantly higher than paediatrics and geriatrics. Antibiotics (39.71%) were the drug class most commonly associated with ADRs. Causality assessment states that majority of the reported ADRs were probable according to WHO-UMC criteria. According to the severity assessment majority of the ADRs were mild in nature. Most of the ADRs were not preventable (76.47%) according to Schumock and Thornton preventability scale. Conclusion: ADR monitoring was found to be useful to measure the effectiveness and safe use of medication.

A two-year retrospective observational study of adverse drug reactions related to intravenous drug formulations

Introduction: Adverse drug reactions are the major obstacles to patient safety and drug therapy monitoring. Objectives: The present article provides information on intravenous products induced adverse drug reactions collected by spontaneous reporting method through an established pharmacovigilance wing working under NCC-PVPI in an Adverse Drug reaction monitoring center-Nalgonda, Telangana. Methods: A total number of 100 intravenous products induced ADRs were collected from different age groups by observational retrospective study for the year January 2018 to December 2019. Results: The results showed that the most affected age group was 20-29 yrs (28 %). The major contribution of the gender that exposed to ADRs was female- 73 % Most intravenous product induced ADRs were reported from the Department of OBG (46 %). Drug: Ceftriaxone-induced ADRs were (38 %). The most frequently reported ADR was fever and chills (56 %). Out of 100 ADRs, one was certain, 90 were probable/likely, and the remaining 9 were possible as per the WHO-causality scale. Conclusions: In the present work, most of the ADRs were because of intravenous antibiotics followed by anesthetic agents, antiepileptic drugs, ringer lactate, dextrose normal saline, and H2 blockers.

Detecting functional disabilities in elderly persons with cardiovascular diseases using the self-reporting method

The ability to perform basic activities of daily living (ADL) and instrumental ADL (IADL) is an essential indicator of the level of functional capacity in old age. The purpose of this paper was to evaluate reliability and validity of the self - reporting method in detecting functional difficulties among elderly persons with cardiovascular diseases. The Groningen Activity Restriction Scale was used to assess the limitations in functional capacity. The sample consisted of patients over the age of 65 with hypertensive disease, angina pectoris, ischaemic heart disease, degenerative valvular disorders, peripheral arterial disease, cardiac arrhythmias, cardiomyopathy and heart failure. The Cronbach’s alpha internal consistency coefficient was calculated for the total result. Differences in outcome with respect to age, educational level, marital status, and medical diagnoses of participants were compared by means of a t-test or one-way ANOVA. In the group of ADL, participants reported difficulties in climbing stairs (M=2.14, SD=1.07) and caring for feet and toenails (M=2.17, SD=1.27), while in the group of IADL, difficulties were present in performing heavier household chores (M=2.51, SD=1.31) as well as ironing and washing clothes (M=2.20, SD=1.29). Calculation of the Cronbach’s alpha coefficient points to a high degree of internal consistency for this scale on a chosen sample (α=0.95). The use of a validated self-reporting tool may be a valuable and reliable way for assessing the functional capacity of elderly persons with chronic diseases. The findings of this study indicate the possibility of using this method for prognostic purposes in patients with cardiovascular diseases. Introduction of instrumental support measures in a timely manner has a crucial role in delaying the progression of functional dependence.

A Novel Method Enables General Pathologists to Create Web Dynamic Forms for Synoptic Tumor Reporting

Context.— Tumor reporting constitutes a significant daily task of pathologists. An efficient tumor-reporting methodology is thus vitally important. The Web dynamic form (WbDF) method offers a multitude of advantages over the prevailing transcription-mediated reporting method based on static-text checklists. However, its adaptation has been severely hampered for 2 decades by its costly needs to maintain a complex back-end system and to change the system for frequent updates of reporting content. Objective.— To overcome these 2 obstacles with a serverless Web platform that enables users to create, customize, use and download WbDFs as synoptic templates for structured tumor reporting. Design.— Deploy ReactJS as a Web platform. Create form components in JavaScript Object Notation files. Use JavaScript Object Notation files to make WbDFs on the Web platform. Use the WbDFs to generate final pathology reports. Results.— Ordinary users (pathologists) can create/customize reporting templates as WbDFs on the Web platform. The WbDF can be used to make a pathology report and stored/shared like ordinary document files. There is no back-end system to change, nor a requirement for computer programming skills. Conclusions.— This strategy eliminates the need for a complex back-end system and the associated cost when updating tumor-reporting standards, making it possible to adopt the WbDF method without the technological drawbacks associated with content updates. It also opens a new field of how the tumor-reporting system should be organized, updated, and implemented.

Regulatory and motivational predictors of procrastination

This is a study of regulatory and motivational predictors of student procrastination. Students procrastinate more than young specialists. With age, procrastination decreases due to self-regulation, but procrastination has negative effects, so it is important to determine its predictors. Probably they will become motivation and self-regulation. For the diagnosis of the studied psychological characteristics were used self-reporting method. The study involved 198 students aged 17 to 24 years (M = 19.47; SD = 1.55), students in 1–4 courses, of which 65 % were girls. The results obtained indicate a negative relationship of procrastination with selfregulation and internal academic motivation, a positive one — with motivation. The features of changes in the severity of procrastination, self-regulation and educational motivation from junior to senior are revealed. It has been established that the most significant contribution to the level of procrastination is made by such functional components of self-regulation as programming and modeling.