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Nevin Manimala Statistics

Reporting of Harm in Randomized Controlled Trials of Therapeutic Exercise for Knee Osteoarthritis: A Systematic Review

Phys Ther. 2021 Jun 26:pzab161. doi: 10.1093/ptj/pzab161. Online ahead of print.

ABSTRACT

OBJECTIVE: The Consolidated Standards of Reporting Trials (CONSORT) recommends reporting adverse events (AEs) and dropouts (DOs) with their definitions. The purpose of this study was to identify how AEs and DOs were reported in randomized controlled trials (RCTs) of therapeutic exercise for knee osteoarthritis (OA).

METHODS: Data sources were the Cochrane Library, EMBASE, PUBMED, and CINAHL. Databases were searched to identify RCTs of therapeutic exercise for Knee OA published from January 1, 1980, through July 23, 2020. Researchers independently extracted participant and intervention characteristics and determined whether a clear statement of and reasons for AEs and DOs existed. The primary outcome was exercise-related harm. Physiotherapy Evidence Database (PEDro) scoring described study quality and risk of bias. Descriptive and inferential statistics characterized results. Meta-analysis was not performed due to data heterogeneity.

RESULTS: One hundred 13 studies (152 arms) from 25 countries were included with 5909 participants exercising. PEDro scores ranged from 4 to 9. Exercise intensity was not specified in 57.9% of exercise arms. Fifty studies (44.2%) included an AE statement and 24 (21.2%) reported AEs, yielding 297 patients. One hundred three studies (91.2%) had a DO statement. Sixteen studies (15.5%) provided reasons for DOs that could be classified as AEs among 39 patients, yielding a 13.1% increase in AEs. Thus, 336 patients (6.0%) experienced exercise-related harm among studies with a clear statement of AEs and DOs. A significant difference existed in misclassification of DOs pre- and post-CONSORT 2010 (12.2% vs 3.1%; X21 = 21.2).

CONCLUSIONS: In some studies, the reason for DOs could be considered AEs, leading to potential underreporting of harm. Improvements in reporting of harm were found pre-and post-CONSORT 2010. Greater clarity regarding AE and DO definitions and TherEx intensity are needed to determine safe dosing and mode of therapeutic exercise for knee OA.

IMPACT: More adherence to the CONSORT statement is needed regarding reporting of and defining AEs, DOs, and therapeutic exercise intensity; however, despite this, therapeutic exercise seems to be associated with minimal risk of harm.

PMID:34180534 | DOI:10.1093/ptj/pzab161

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Nevin Manimala Statistics

Subgroup analyses in randomized clinical trials: Value and limitations Review #3 on important aspects of randomized clinical trials in cardiovascular pharmacotherapy

Eur Heart J Cardiovasc Pharmacother. 2021 Jun 28:pvab048. doi: 10.1093/ehjcvp/pvab048. Online ahead of print.

NO ABSTRACT

PMID:34180504 | DOI:10.1093/ehjcvp/pvab048

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Nevin Manimala Statistics

The adaptation of the ‘Healthcare Complaints Analysis Tool’ for general practice

Fam Pract. 2021 Jun 28:cmab040. doi: 10.1093/fampra/cmab040. Online ahead of print.

ABSTRACT

BACKGROUND: Patient complaints about care in general practice are underutilized as a source of safety improvement data.

OBJECTIVE: This study aimed to adapt a secondary care complaints analysis tool for use in general practice contexts and assess the validity, reliability and usability of the adapted tool.

METHODS: The study was conducted in two phases. Phase A: The Healthcare Complaints Analysis Tool (HCAT) designed for use in secondary care was adapted for use in general practice using an iterative six-stage process. Phase B: Participants from key stakeholder groups [General practitioners (n = 5), complaints managers (n = 9), health service researchers (n = 4)]. Participants completed an online survey and analysed 20 fictionalized patient complaints using the adapted tool. Inter-rater reliability and agreement with a referent standard were analysed using Gwet’s AC1 statistic.

RESULTS: Phase A: The HCAT was adapted to the Healthcare Complaints Analysis Tool (General Practice) [HCAT(GP)]. The HCAT(GP) tool consists of three domains (clinical, management and relationship problems), and seven categories. The HCAT(GP) had both content and face validity. Phase B: Inter-rater reliability was substantial for the HCAT(GP) categories (Gwet’s AC1 = 0.65). Within-group agreement on the seven HCAT(GP) categories was substantial to perfect (AC1 0.61-0.85). Participants had substantial to perfect agreement with the referent standard across the survey with a mean AC1 of 0.899 (Range 0.76-0.97).

CONCLUSIONS: This study reports the adaptation of the HCAT(GP) and has established that the tool has sufficient validity, reliability and usability. This adapted tool can be applied to general practice complaints to identify areas for improvement.

PMID:34180507 | DOI:10.1093/fampra/cmab040

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Nevin Manimala Statistics

The relationship between physical activity attitude and life satisfaction: A sample of university students in Turkey

Work. 2021 Jun 23. doi: 10.3233/WOR-213513. Online ahead of print.

ABSTRACT

BACKGROUND: Physical activity is very important for a healthy life in the human existence, and regular physical activity and high attitudes towards physical activity can contribute to higher levels of life satisfaction of individuals.

OBJECTIVE: This study aimed to investigate the relationship between university students’ attitudes towards physical activity and their life satisfaction levels.

METHODS: In the study, the Cognitive Behavioral Physical Activity Questionnaire was used to measure the participants’ attitudes towards physical activity. In order to measure the participants’ life satisfaction levels, The Satisfaction with Life Scale was used. Descriptive statistics, independent sample t-test, One-way ANOVA, Pearson correlation analysis, and regression analysis were used in the analysis of the obtained data.

RESULTS: According to gender, it was determined that there was a statistically significant difference both in the result expectation and self-regulation sub-dimensions of physical activity attitude and the total score of physical activity attitude. When the correlation analysis results were analyzed, the statistically significant positive relationship between life satisfaction and outcome expectation, self-regulation sub-dimensions of physical activity attitude, and the total score of physical activity attitude was determined. Also, it was found that the attitude towards physical activity explained approximately 6%of life satisfaction.

CONCLUSIONS: It was determined that as the attitudes of the participants towards physical activity increased, their life satisfaction increased.

PMID:34180453 | DOI:10.3233/WOR-213513

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Nevin Manimala Statistics

Cortical structural changes related to early antiretroviral therapy (ART) interruption in perinatally HIV-infected children at 5 years of age

IBRO Neurosci Rep. 2021 Feb 10;10:161-170. doi: 10.1016/j.ibneur.2021.02.001. eCollection 2021 Jun.

ABSTRACT

ART interruption in children can occur especially in resource-limited settings for reasons including poor adherence, stock-outs, ART intolerance of non-pediatric formulas and pill size, as well as ultimately to test for HIV remission. Although early ART initiation is now standard of care in pediatric HIV management, very little is known on the effect of early ART initiation or subsequent interruption on brain development. This study aimed to investigate the effect of ART interruption on brain cortical thickness (CT) and folding in a subset of children from the Children with HIV Early antiRetroviral therapy (CHER) trial cohort who all started ART before 18 months of age. CHER participants in the neuroimaging follow-up study had magnetic resonance (MRI) scans on a 3T Siemens Allegra brain scanner at age 5.44 ± 0.37 years. MR images were processed using the automated cross-sectional stream in FreeSurfer v6.0 and vertex wise comparisons of CT and local gyrification indices (LGIs) were performed between HIV+ children and HIV- controls, as well as between HIV+ children on interrupted or continuous ART and controls. HIV+ children (n = 46) showed thicker cortex than HIV- children (n = 29) in bilateral frontal and left temporo-insular regions but lower LGIs in left superior and bilateral medial orbitofrontal cortex extending into rostral anterior cingulate. Children on interrupted ART (n = 21) had thicker cortex than HIV- controls in left frontal and right insular regions, but children on continuous treatment (n = 25) showed no difference from controls. Children on both interrupted and continuous ART showed region-specific alterations in LGI relative to controls. Cortical folding appears more sensitive than CT to early life events including early ART and interruption. However, immune health resilience in children can translate to long term preservation of morphometric brain development, especially for those on early and continuous treatment.

PMID:34179869 | PMC:PMC8211921 | DOI:10.1016/j.ibneur.2021.02.001

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Nevin Manimala Statistics

Group IIA secretory phospholipase 2 independently predicts mortality and positive blood culture in emergency department sepsis patients

J Am Coll Emerg Physicians Open. 2021 Jun 18;2(3):e12460. doi: 10.1002/emp2.12460. eCollection 2021 Jun.

ABSTRACT

OBJECTIVE: The IIA isoform of phospholipase A2 is an acute phase reactant that increases in sepsis, although data regarding its prognostic value are limited. We hypothesized that group IIA secretory phospholipase A2 (sPLA2-IIA) predicts sepsis mortality and positive cultures and sought to compare its predictive characteristics to lactate and procalcitonin.

METHODS: sPLA2-IIA and procalcitonin levels were measured at enrollment in emergency department patients with early severe sepsis and compared with lactate levels. The primary outcome was in-hospital mortality. The secondary outcome was any positive culture with a sub-group analysis of only blood-culture positive patients. Optimum cut-point was determined using receiver operating characteristics curves. A multivariable model was developed to test the independent prognostic value of elevated sPLA2-IIA to predict mortality.

RESULTS: Of the 192 patients in the cohort, 160, 153, and 158 had samples available for analysis of sPLA2-IIA, procalcitonin, and lactate, respectively. A total of 21% of patients met the primary outcome of in-hospital mortality. At a 100 ng/mL threshold for sPLA2-IIA, adjusted odds to predict mortality were 3.78 (95% confidence interval = 1.14-12.56, P = 0.03). sPLA2-IIA and procalcitonin were both elevated in culture-positive patients; however, the difference was not statistically significant. sPLA2-IIA was significantly higher in blood culture-positive patients.

CONCLUSION: An elevated level of sPLA2-IIA was associated with increased mortality in sepsis patients. sPLA2-IIA levels, unlike procalcitonin, also were significantly higher in blood culture-positive patients.

PMID:34179883 | PMC:PMC8212558 | DOI:10.1002/emp2.12460

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Nevin Manimala Statistics

Quantum processor-inspired machine learning in the biomedical sciences

Patterns (N Y). 2021 Apr 28;2(6):100246. doi: 10.1016/j.patter.2021.100246. eCollection 2021 Jun 11.

ABSTRACT

Recent advances in high-throughput genomic technologies coupled with exponential increases in computer processing and memory have allowed us to interrogate the complex molecular underpinnings of human disease from a genome-wide perspective. While the deluge of genomic information is expected to increase, a bottleneck in conventional high-performance computing is rapidly approaching. Inspired by recent advances in physical quantum processors, we evaluated several unconventional machine-learning (ML) strategies on actual human tumor data, namely “Ising-type” methods, whose objective function is formulated identical to simulated annealing and quantum annealing. We show the efficacy of multiple Ising-type ML algorithms for classification of multi-omics human cancer data from The Cancer Genome Atlas, comparing these classifiers to a variety of standard ML methods. Our results indicate that Ising-type ML offers superior classification performance with smaller training datasets, thus providing compelling empirical evidence for the potential future application of unconventional computing approaches in the biomedical sciences.

PMID:34179840 | PMC:PMC8212142 | DOI:10.1016/j.patter.2021.100246

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Nevin Manimala Statistics

Repeats expansions in ATXN2, NOP56, NIPA1 and ATXN1 are not associated with ALS in Africans

IBRO Neurosci Rep. 2021 Feb 10;10:130-135. doi: 10.1016/j.ibneur.2021.02.002. eCollection 2021 Jun.

ABSTRACT

Amyotrophic lateral sclerosis (ALS) is a fatal neurodegenerative disease characterized primarily by progressive loss of motor neurons. Although ALS occurs worldwide and the frequency and spectrum of identifiable genetic causes of disease varies across populations, very few studies have included African subjects. In addition to a hexanucleotide repeat expansion (RE) in C9orf72, the most common genetic cause of ALS in Europeans, REs in ATXN2, NIPA1 and ATXN1 have shown variable associations with ALS in Europeans. Intermediate range expansions in some of these genes (e.g. ATXN2) have been reported as potential risk factors, or phenotypic modifiers, of ALS. Pathogenic expansions in NOP56 cause spinocerebellar ataxia-36, which can present with prominent motor neuron degeneration. Here we compare REs in these genes in a cohort of Africans with ALS and population controls using whole genome sequencing data. Targeting genotyping of short tandem repeats at known loci within ATXN2, NIPA1, ATXN1 and NOP56 was performed using ExpansionHunter software in 105 Southern African (SA) patients with ALS. African population controls were from an in-house SA population control database (n = 25), the SA Human Genome Program (n = 24), the Simons Genome Diversity Project (n = 39) and the Illumina Polaris Diversity Cohort (IPDC) dataset (n = 50). We found intermediate RE alleles in ATXN2 (27-33 repeats) and ATXN1 (33-35 repeats), and NIPA1 long alleles (≥8 repeats) were rare in Africans, and not associated with ALS (p > 0.17). NOP56 showed no expanded alleles in either ALS or controls. We also compared the differences in allele distributions between the African and n = 50 European controls (from the IPDC). There was a statistical significant difference in the distribution of the REs in the ATXN1 between African and European controls (Chi-test p < 0.001), and NIPA1 showed proportionately more longer alleles (RE > 8) in Europeans vs. Africans (Fisher’s p = 0.016). The distribution of RE alleles in ATXN2 and NOP56 were similar amongst African and European controls. In conclusion, repeat expansions in ATXN2, NIPA1 and ATXN1, which showed associations with ALS in Europeans, were not replicated in Southern Africans with ALS.

PMID:34179866 | PMC:PMC8211917 | DOI:10.1016/j.ibneur.2021.02.002

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Morphological and Fitness Attributes of Young Male Portuguese Basketball Players: Normative Values According to Chronological Age and Years From Peak Height Velocity

Front Sports Act Living. 2021 Jun 10;3:629453. doi: 10.3389/fspor.2021.629453. eCollection 2021.

ABSTRACT

The aims of the present study were: (i) to describe the structural and functional attributes of young male Portuguese basketball players aged 12-16 years and (ii) to generate normative data according to chronological age and years from peak height velocity. A total of 281 male Portuguese young basketball players between the ages of 12 and 16 years were assessed in this study. Chronological age, maturity parameters (maturity offset and predicted age at peak height velocity), morphological (body mass, height, and skinfolds and length), and fitness (sprint, change of direction ability, jump, and upper body strength) attributes were measured. Descriptive statistics were determined for the age and maturity status, and the 10th, 25th, 50th, 75th, and 90th percentiles were chosen as reference values. Descriptive and normative values of the players’ morphological and fitness attributes, stratified by age and maturity status, are provided. The normative values of age at peak height velocity (category YAPHV = 0) showed that regional basketball players presented average values (50th percentile) of 169.8 cm for height, 173.3 cm for arm span, 55.6 kg for body mass, 3.34 s for the 20-m speed test, 10.31 s for the T-test, 4.75 m for the 2-kg medicine ball throw, 66.9 kg for the combined right and left handgrip strength, and 30.1 and 35.9 cm for jump height in the countermovement jump (CMJ) and CMJ with arm swing, respectively. In conclusion, these results may be helpful to quantify and control an athlete’s performance over time and to adjust strength and conditioning programs to biological demands.

PMID:34179772 | PMC:PMC8222820 | DOI:10.3389/fspor.2021.629453

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Nevin Manimala Statistics

CoviChain: A Blockchain Based Framework for Nonrepudiable Contact Tracing in Healthcare Cyber-Physical Systems During Pandemic Outbreaks

SN Comput Sci. 2021;2(5):346. doi: 10.1007/s42979-021-00746-x. Epub 2021 Jun 20.

ABSTRACT

With the world facing the new virus SARS-CoV-2, many countries have introduced instant Internet applications to identify people carrying the infection. Internet-of-Medical-Things (IoMT) have proven useful in collecting medical data as well in tracing an individual carrying the virus. The data collected or traced belongs to an individual and should be revealed to themselves and hospital providers, but not to any third-party unauthorized agencies. In this paper we use an off-chain distributed storage solution for loading large medical data sets and a blockchain implementation to securely transfer the data from the infected person to the hospital system using the edge infrastructure, and call it CoviChain. The Coronavirus Disease (COVID-19) statistics are loaded on to the edge, and moved to InterPlanetary File Systems (IPFS) storage to retrieve the hash of the data file. Once the hash is obtained, it is moved to the blockchain by means of smart contracts. As the information is being hashed twice, CoviChain addresses the security and privacy issues and avoid exposing individuals’ data while achieving larger data storage on the blockchain with reduced cost and time.

PMID:34179827 | PMC:PMC8214843 | DOI:10.1007/s42979-021-00746-x