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Nevin Manimala Statistics

Protocol for developing a healthcare transition intervention for young people with spinal cord injuries using a participatory action research approach

BMJ Open. 2021 Jul 29;11(7):e053212. doi: 10.1136/bmjopen-2021-053212.

ABSTRACT

INTRODUCTION: While healthcare transition (HCT) interventions are recognised as an important area in paediatric rehabilitation, there has been limited research focusing on young people with spinal cord injuries (SCI). In this study, researchers will collaborate with young people with SCI and their parents/caregivers to develop, implement and evaluate the feasibility and acceptability of a HCT intervention aimed at supporting young people with SCI during their transition from paediatric to adult healthcare services.

METHODS AND ANALYSIS: A participatory action research (PAR) approach will be used to co-develop the HCT intervention with young people with SCI aged 14-25 years and their parents/caregivers. Three phases will be conducted to address the five objectives of this study. Phase 1 will use semi-structured interviews to explore young people and parent/caregivers’ experiences of HCT. In Phase 2a, both young people and parent/caregivers will be co-researchers. They will be included in the analysis of the interviews and will be asked to participate in co-design workshops to inform the development of a prototype HCT intervention. In Phase 2b, using focus groups, feedback on the prototype HCT intervention will be collected. In Phase 3, the refined prototype HCT intervention will be implemented, and young people with SCI and parent/caregivers will evaluate the feasibility and acceptability of the HCT intervention in semi-structured interviews. A reference group, including stakeholders and end users, will be consulted at different time points.

ETHICS AND DISSEMINATION: The study has received ethics approval from Western Sydney University Human Research and Ethics Committee (H14029). The researcher will use the results of this study as chapters in a thesis to obtain a Doctor of Philosophy degree. The findings will be disseminated via publication in peer-reviewed journals and will be presented at local, national or international conferences.

TRIAL REGISTRATION NUMBER: ACTRN12621000500853.

PMID:34326059 | DOI:10.1136/bmjopen-2021-053212

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TCF7L2 Genetic Variants Do Not Influence Insulin Sensitivity or Secretion Indices in Autoantibody-Positive Individuals at Risk for Type 1 Diabetes

Diabetes Care. 2021 Jul 29:dc210531. doi: 10.2337/dc21-0531. Online ahead of print.

ABSTRACT

OBJECTIVE: We aimed to test whether type 2 diabetes (T2D)-associated TCF7L2 genetic variants affect insulin sensitivity or secretion in autoantibody-positive relatives at risk for type 1 diabetes (T1D).

RESEARCH DESIGN AND METHODS: We studied autoantibody-positive TrialNet Pathway to Prevention study participants (N = 1,061) (mean age 16.3 years) with TCF7L2 single nucleotide polymorphism (SNP) information and baseline oral glucose tolerance test (OGTT) to calculate indices of insulin sensitivity and secretion. With Bonferroni correction for multiple comparisons, P values < 0.0086 were considered statistically significant.

RESULTS: None, one, and two T2D-linked TCF7L2 alleles were present in 48.1%, 43.9%, and 8.0% of the participants, respectively. Insulin sensitivity (as reflected by 1/fasting insulin [1/IF]) decreased with increasing BMI z score and was lower in Hispanics. Insulin secretion (as measured by 30-min C-peptide index) positively correlated with age and BMI z score. Oral disposition index was negatively correlated with age, BMI z score, and Hispanic ethnicity. None of the indices were associated with TCF7L2 SNPs. In multivariable analysis models with age, BMI z score, ethnicity, sex, and TCF7L2 alleles as independent variables, C-peptide index increased with age, while BMI z score was associated with higher insulin secretion (C-peptide index), lower insulin sensitivity (1/IF), and lower disposition index; there was no significant effect of TCF7L2 SNPs on any of these indices. When restricting the analyses to participants with a normal OGTT (n = 743; 70%), the results were similar.

CONCLUSIONS: In nondiabetic autoantibody-positive individuals, TCF7L2 SNPs were not related to insulin sensitivity or secretion indices after accounting for BMI z score, age, sex, and ethnicity.

PMID:34326068 | DOI:10.2337/dc21-0531

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Does an innovative paper-based health information system (PHISICC) improve data quality and use in primary healthcare? Protocol of a multicountry, cluster randomised controlled trial in sub-Saharan African rural settings

BMJ Open. 2021 Jul 29;11(7):e051823. doi: 10.1136/bmjopen-2021-051823.

ABSTRACT

INTRODUCTION: Front-line health workers in remote health facilities are the first contact of the formal health sector and are confronted with life-saving decisions. Health information systems (HIS) support the collection and use of health related data. However, HIS focus on reporting and are unfit to support decisions. Since data tools are paper-based in most primary healthcare settings, we have produced an innovative Paper-based Health Information System in Comprehensive Care (PHISICC) using a human-centred design approach. We are carrying out a cluster randomised controlled trial in three African countries to assess the effects of PHISICC compared with the current systems.

METHODS AND ANALYSIS: Study areas are in rural zones of Côte d’Ivoire, Mozambique and Nigeria. Seventy health facilities in each country have been randomly allocated to using PHISICC tools or to continuing to use the regular HIS tools. We have randomly selected households in the catchment areas of each health facility to collect outcomes’ data (household surveys have been carried out in two of the three countries and the end-line data collection is planned for mid-2021). Primary outcomes include data quality and use, coverage of health services and health workers satisfaction; secondary outcomes are additional data quality and use parameters, childhood mortality and additional health workers and clients experience with the system. Just prior to the implementation of the trial, we had to relocate the study site in Mozambique due to unforeseen logistical issues. The effects of the intervention will be estimated using regression models and accounting for clustering using random effects.

ETHICS AND DISSEMINATION: Ethics committees in Côte d’Ivoire, Mozambique and Nigeria approved the trials. We plan to disseminate our findings, data and research materials among researchers and policy-makers. We aim at having our findings included in systematic reviews on health systems interventions and future guidance development on HIS.

TRIAL REGISTRATION NUMBER: PACTR201904664660639; Pre-results.

PMID:34326056 | DOI:10.1136/bmjopen-2021-051823

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Sample size determination and power analysis using the G*Power software

J Educ Eval Health Prof. 2021;18:17. doi: 10.3352/jeehp.2021.18.17. Epub 2021 Jul 30.

ABSTRACT

Appropriate sample size calculation and power analysis have become major issues in research and publication processes. However, the complexity and difficulty of calculating sample size and power require broad statistical knowledge, there is a shortage of personnel with programming skills, and commercial programs are often too expensive to use in practice. The review article aimed to explain the basic concepts of sample size calculation and power analysis; the process of sample estimation; and how to calculate sample size using G*Power software (latest ver. 3.1.9.7; Heinrich-Heine-Universität Düsseldorf, Düsseldorf, Germany) with 5 statistical examples. The null and alternative hypothesis, effect size, power, alpha, type I error, and type II error should be described when calculating the sample size or power. G*Power is recommended for sample size and power calculations for various statistical methods (F, t, χ2, Z, and exact tests), because it is easy to use and free. The process of sample estimation consists of establishing research goals and hypotheses, choosing appropriate statistical tests, choosing one of 5 possible power analysis methods, inputting the required variables for analysis, and selecting the “Calculate” button. The G*Power software supports sample size and power calculation for various statistical methods (F, t, χ2, z, and exact tests). This software is helpful for researchers to estimate the sample size and to conduct power analysis.

PMID:34325496 | DOI:10.3352/jeehp.2021.18.17

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Cardiac Output Measurement in Neonates and Children Using Noninvasive Electrical Bioimpedance Compared With Standard Methods: A Systematic Review and Meta-Analysis

Crit Care Med. 2021 Jul 29. doi: 10.1097/CCM.0000000000005144. Online ahead of print.

ABSTRACT

OBJECTIVE: To systematically review and meta-analyze the validity of electrical bioimpedance-based noninvasive cardiac output monitoring in pediatrics compared with standard methods such as thermodilution and echocardiography.

DATA SOURCES: Systematic searches were conducted in MEDLINE and EMBASE (2000-2019).

STUDY SELECTION: Method-comparison studies of transthoracic electrical velocimetry or whole body electrical bioimpedance versus standard cardiac output monitoring methods in children (0-18 yr old) were included.

DATA EXTRACTION: Two reviewers independently performed study selection, data extraction, and risk of bias assessment. Mean differences of cardiac output, stroke volume, or cardiac index measurements were pooled using a random-effects model (R Core Team, R Foundation for Statistical Computing, Vienna, Austria, 2019). Bland-Altman statistics assessing agreement between devices and author conclusions about inferiority/noninferiority were extracted.

DATA SYNTHESIS: Twenty-nine of 649 identified studies were included in the qualitative analysis, and 25 studies in the meta-analyses. No significant difference was found between means of cardiac output, stroke volume, and cardiac index measurements, except in exclusively neonatal/infant studies reporting stroke volume (mean difference, 1.00 mL; 95% CI, 0.23-1.77). Median percentage error in child/adolescent studies approached acceptability (percentage error less than or equal to 30%) for cardiac output in L/min (31%; range, 13-158%) and stroke volume in mL (26%; range, 14-27%), but not in neonatal/infant studies (45%; range, 29-53% and 45%; range, 28-70%, respectively). Twenty of 29 studies concluded that transthoracic electrical velocimetry/whole body electrical bioimpedance was noninferior. Transthoracic electrical velocimetry was considered inferior in six of nine studies with heterogeneous congenital heart disease populations.

CONCLUSIONS: The meta-analyses demonstrated no significant difference between means of compared devices (except in neonatal stroke volume studies). The wide range of percentage error reported may be due to heterogeneity of study designs, devices, and populations included. Transthoracic electrical velocimetry/whole body electrical bioimpedance may be acceptable for use in child/adolescent populations, but validity in neonates and congenital heart disease patients remains uncertain. Larger studies in specific clinical contexts with standardized methodologies are required.

PMID:34325447 | DOI:10.1097/CCM.0000000000005144

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A template for physical resilience research in older adults: Methods of the PRIME-KNEE study

J Am Geriatr Soc. 2021 Jul 29. doi: 10.1111/jgs.17384. Online ahead of print.

ABSTRACT

BACKGROUND: Older adults with similar health conditions often experience widely divergent outcomes following health stressors. Variable recovery after a health stressor may be due in part to differences in biological mechanisms at the molecular, cellular, or system level, that are elicited in response to stressors. We describe the PRIME-KNEE study as an example of ongoing research to validate provocative clinical tests and biomarkers that predict resilience to specific health stressors.

METHODS: PRIME-KNEE is an ongoing, prospective cohort study that will enroll 250 adults ≥60 years undergoing total knee arthroplasty. Data are collected at baseline (pre-surgery), during surgery, daily for 7 days after surgery, and at 1, 2, 4, and 6 months post-surgery. Provocative tests include a cognition-motor dual-task walking test, cerebrovascular reactivity assessed by functional near-infrared spectroscopy, peripheral blood mononuclear cell reactivity ex vivo to lipopolysaccharide toxin and influenza vaccine, and heart rate variability during surgery. Cognitive, psychological, and physical performance batteries are collected at baseline to estimate prestressor reserve. Demographics, medications, comorbidities, and stressor characteristics are abstracted from the electronic medical record and via participant interview. Blood-based biomarkers are collected at baseline and postoperative day 1. Repeated measures after surgery include items from a delirium assessment tool and pain scales administered daily by telephone for 7 days and cognitive change index (participant and informant), lower extremity activities of daily living, pain scales, and step counts assessed by Garmin actigraphy at 1, 2, 4, and 6 months after surgery. Statistical models use these measures to characterize resilience phenotypes and evaluate prestressor clinical indicators associated with poststressor resilience.

CONCLUSION: If PRIME-KNEE validates feasible clinical tests and biomarkers that predict recovery trajectories in older surgical patients, these tools may inform surgical decision-making, guide pre-habilitation efforts, and elucidate mechanisms underlying resilience. This study design could motivate future geriatric research on resilience.

PMID:34325481 | DOI:10.1111/jgs.17384

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The relationships of nursing students’ satisfaction and self-confidence after a simulation-based course with their self-confidence while practicing on real patients in Vietnam

J Educ Eval Health Prof. 2021;18:16. doi: 10.3352/jeehp.2021.18.16. Epub 2021 Jul 30.

ABSTRACT

PURPOSE: Simulation teaching refers to the replication of real-life scenarios, enabling students to practice nursing skills and learn actively in a safe environment. It also helps students control their anxiety and fears when caring for real patients. This study investigated the relationships of Vietnamese nursing students’ self-confidence in clinical practice with their satisfaction and self-confidence in simulation-based practice.

METHODS: This cross-sectional descriptive study included 182 nursing students. The data collection included 2 separate stages with 2 main questionnaires. The Student Satisfaction and Self-Confidence in Learning Scale was used to measure students’ satisfaction and self-confidence after learning in the simulation room. The Confidence Scale was used to measure students’ self-confidence when first performing techniques on actual patients. Data were analyzed by descriptive and Pearson correlation statistics.

RESULTS: Students’ satisfaction and self-confidence during the simulation course were quite high (mean±standard deviation [SD], 4.06±0.48 and 4.11±0.46 out of 5.0, respectively). In contrast, their confidence when first practicing on a patient was moderate (mean±SD, 3.19±0.62 out of 5.0). Students’ satisfaction showed moderate and weak positive correlations with self-confidence in pre-clinical practice and in clinical practice (r=0.33, P<0.001 and r=0.26, P<0.001, respectively).

CONCLUSION: Simulation has become an effective teaching strategy that can help nursing students be well-prepared for clinical placements in Vietnam. An effective nursing education strategy is needed to enhance the satisfaction and self-confidence of nursing students in simulation and then in clinical practice to help achieve professional engagement and development.

PMID:34325495 | DOI:10.3352/jeehp.2021.18.16

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Time to a Negative SARS-CoV-2 PCR Predicts Delayed Return to Work After Medical Leave in COVID-19 Infected Health Care Workers

J Occup Environ Med. 2021 Jul 27. doi: 10.1097/JOM.0000000000002336. Online ahead of print.

ABSTRACT

OBJECTIVE: To investigate whether health care workers’ (HCWs) return to work (RTW) after coronavirus disease 2019 (COVID-19) was associated with time to a negative viral detection test.

METHODS: To evaluate the association of return to work (RTW) with an undetectable RT-PCR adjusting for different factors.

RESULTS: 375 HCWs who required medical leave for COVID-19 at a hospital in Madrid. Multivariable analyses confirmed the association of delayed RTW with interval to negative PCR (ORadj 1.12, 95% CI 1.08, 1.17) as well as age, sex, and nursing staff and clinical support services compared to physicians. A predictive model based on those variables is proposed, which had an area under the receiver operating curve of 0.82.

CONCLUSIONS: Delayed RTW was associated with longer interval to a negative RT-PCR after symptom onset, adjusting for occupational category, age, and sex.

PMID:34325436 | DOI:10.1097/JOM.0000000000002336

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Measuring Proximal Tibial Metaphyseal Width and Lateral Epiphyseal Height Improves Determination of Remaining Growth in Children

J Pediatr Orthop. 2021 Jul 29. doi: 10.1097/BPO.0000000000001853. Online ahead of print.

ABSTRACT

BACKGROUND: Accurate assessments of skeletal maturity is of critical importance to guide type and timing of orthopaedic surgical interventions. Several quantitative markers of the proximal tibia were recently developed using historical knee radiographs. The purpose of the present study was to determine which marker would be most effective in assessment of full-length radiographs in a modern pediatric patient population.

METHODS: All full-length radiographs at our institutions between 2013 and 2018 were reviewed. Inclusion criteria for our study required that the child reached final height as defined by 2 consecutive unchanged heights, at least 6 months apart, after age 16 for boys and 14 for girls. Patients with metabolic bone disease, prior surgery such as epiphysiodesis, or previous infections around the knee were excluded. Summary statistics for each of the 3 proximal tibial ratios were calculated and multiple linear regression was performed with percent of growth remaining as a dependent variable. A recommended regression model is presented and evaluated.

RESULTS: A total of 692 full-length radiographs met inclusion criteria. Proximal tibial ratios were calculated and averaged values for each percent of growth remaining was presented. Multiple linear regression demonstrated that using all 3 variables led to overfitting of the model so tibial metaphyseal width/lateral tibial epiphyseal height was selected as the optimal ratio for use by clinicians. The optimal model for determining growth was found to have R2=0.723 in the developmental set and R2=0.762 in an excluded validation set.

CONCLUSIONS: This study demonstrates that the proximal tibial metaphyseal width/lateral tibial epiphyseal height is the ideal measurement for clinicians seeking to determine growth remaining in children. It presents average values between 0% and 25% of growth remaining. This study also develops and validates a multivariable regression model for determining percentage of growth remaining in children that will allow for quantitative determination of growth using full-length radiographs.

LEVEL OF EVIDENCE: Level III.

PMID:34325444 | DOI:10.1097/BPO.0000000000001853

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Admission Hemoglobin Is Prognostic for In-Hospital Mortality in Oldest-Old Patients with Acute Ischemic Stroke

Gerontology. 2021 Jul 29:1-8. doi: 10.1159/000514678. Online ahead of print.

ABSTRACT

INTRODUCTION: Anemia is a common condition encountered in acute ischemic stroke, and only a few pieces of evidence has been produced suggesting its possible association with short-term mortality have been produced. The study sought to assess whether admission anemia status had any impact on short-term clinical outcome among oldest-old patients with acute ischemic stroke.

MATERIALS AND METHODS: A retrospective review of Electronic Medical Recording System was performed in 2 tertiary hospitals. Data, from the oldest-old patients aged > = 80 years consecutively admitted with a diagnosis of acute ischemic stroke between January 1, 2015, and December 31, 2019, were analyzed. Admission hemoglobin was used as indicator for anemia and severity. Univariate and multivariate regression analyses were used to compare in-hospital mortality and length of in-hospital stay in different anemia statuses and normal hemoglobin patients.

RESULTS: A total of 705 acute ischemic stroke patients were admitted, and 572 were included in the final analysis. Of included patients, 240 of them were anemic and 332 nonanemic patients. A statistical difference between the 2 groups was found in in-hospital mortality (p < 0.001). After adjustment for baseline characteristics, the odds ratio value of anemia for mortality were 3.91 (95% confidence intervals (CI) 1.60-9.61, p = 0.003) and 7.15 (95% CI: 1.46-34.90, p = 0.015) in moderate and severely anemic patients, respectively. Similarly, length of in-hospital stay was longer in anemic patients (21.64 ± 6.17 days) than in nonanemic patients (19.08 ± 5.48 days, p < 0.001).

CONCLUSIONS: Increased severity of anemia may be an independent risk factor for increased in-hospital mortality and longer length of stay in oldest-old patients with acute ischemic stroke.

PMID:34325428 | DOI:10.1159/000514678