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Nevin Manimala Statistics

Delirium detection methodologies: Implications for outcome measurement in clinical trials in postoperative delirium

Int J Geriatr Psychiatry. 2022 Mar;37(3). doi: 10.1002/gps.5695.

ABSTRACT

OBJECTIVE: Delirium is a common postoperative complication of hip fracture. Various methods exist to detect delirium as a reference standard. The goal of this study was to characterize the properties of the measures obtained in a randomized controlled trial, to document their relationship to the Diagnostic and Statistical Manual of Mental Disorders:Text Revision based diagnosis of postoperative delirium by a consensus panel, and to describe the method in detail to allow replication by others.

METHODS: A secondary analysis of the randomized trial STRIDE (A Strategy to Reduce the Incidence of Postoperative Delirium in Elderly Patients) was conducted. Delirium assessments were performed in 200 consecutive hip fracture repair patients ≥65 years old. Assessors underwent extensive training in delirium assessment and the final delirium diagnosis was adjudicated by a consensus panel of three physicians with expertise in delirium assessment.

RESULTS: A total of 680 consensus panel delirium diagnoses were completed. There were only 19 (2.8%, 19/678) evaluations where the delirium adjudication by the consensus panel differed from delirium findings by the Confusion Assessment Method (CAM). In 16 (84%, 16/19) of the cases, CAM was negative but the consensus panel diagnosed the patient as having delirium based on all of the available information including the CAM.

CONCLUSION: The consensus panel diagnosis was more sensitive compared to CAM alone, however the magnitude of the difference was not large. When assessors are well trained and delirium assessments are closely supervised throughout the study, CAM may be adequate for delirium diagnosis in a clinical trial. Future studies are needed to test this hypothesis.

PMID:35170079 | DOI:10.1002/gps.5695

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Nevin Manimala Statistics

Motor skills and intelligence in children with fetal alcohol spectrum disorder

Dev Med Child Neurol. 2022 Feb 15. doi: 10.1111/dmcn.15175. Online ahead of print.

ABSTRACT

AIM: To determine the relationship between motor abilities and intelligence in children and young people with prenatal alcohol exposure (PAE) being assessed for fetal alcohol spectrum disorder (FASD).

METHOD: This was a cross-sectional correlational study of children and young people with PAE being assessed for FASD. The relationship between motor abilities (Movement Assessment Battery for Children, Second Edition) and intelligence (Wechsler Intelligence Scale for Children, Fourth or Fifth Edition) was calculated using correlation and regression analyses. Attention and executive function were considered as potential confounding variables.

RESULTS: The relationship between motor abilities and intelligence in 73 children and young people (48 males, 25 females; aged 6-17y, mean age 10y 5mo [SD 2y 9mo]) assessed for FASD was small and statistically non-significant (r=0.05, p=0.67).

INTERPRETATION: The findings confirm that motor abilities and intelligence should be assessed separately when investigating an FASD diagnosis. Intelligence scores should not be used to estimate motor abilities, nor should they dictate when motor testing be completed. Assessing intelligence and motor domains separately will enhance diagnostic accuracy, identify the need for strategies or interventions to address functional motor skills, and further define the role of physiotherapy and occupational therapy in FASD assessment and intervention.

PMID:35170025 | DOI:10.1111/dmcn.15175

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Nevin Manimala Statistics

Better than ‘normal’: Describing the distribution of and outliers in RBC usage

Transfusion. 2022 Feb 16. doi: 10.1111/trf.16831. Online ahead of print.

ABSTRACT

BACKGROUND/CASE STUDIES: Optimizing a hospital blood inventory requires understanding the distribution of blood usage at the institution. Standard methods for describing red blood cell (RBC) usage like mean and standard deviation assume a normal distribution. Other distributions may fit the distribution of daily RBC usage better and provide more accurate insights into blood usage and in6ventory management.

STUDY DESIGN/METHODS: RBC usage data from 2014 through 2020 were queried from the laboratory information system. Theoretical distributions were fit against this empirical distribution of daily RBC usage. Goodness-of-fit was assessed visually using Pearson/Cullen and Frey plots as well as quantitatively using Kolomogorov-Smirnov (K-S) distance and the Akaike Information Criterion (AIC).

RESULTS/FINDINGS: 241,957 units of RBCs were transfused over 2557 days in the study period. The log-normal and gamma distributions had superior K-S distances and AICs for daily RBC usage. The top percentile of days for RBC usage was significantly more likely to have at least one ultramassively transfused patient (p < .001, Fisher’s Exact Test).

CONCLUSIONS: The log-normal and gamma distributions better describe the right-skewed and entirely positive empirical distribution of daily RBC usage as compared to the normal distribution. This should broadly inform inventory management efforts and future descriptions of RBC usage at the institutional level.

PMID:35170040 | DOI:10.1111/trf.16831

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Nevin Manimala Statistics

ISPE-endorsed guidance in using electronic health records for comparative effectiveness research in COVID-19: opportunities and trade-offs

Clin Pharmacol Ther. 2022 Feb 16. doi: 10.1002/cpt.2560. Online ahead of print.

ABSTRACT

As the scientific research community along with health care professionals and decision-makers around the world fight tirelessly against the COVID-19 pandemic, the need for comparative effectiveness research (CER) on preventive and therapeutic interventions for COVID-19 is immense. Randomized controlled trials markedly underrepresent the frail and complex patients seen in routine care, and they do not typically have data on long-term treatment effects. The increasing availability of electronic health records (EHRs) for clinical research offers the opportunity to generate timely real-world evidence reflective of routine care for optimal management of COVID-19. However, there are many potential threats to the validity of CER based on EHR data that are not originally generated for research purposes. To ensure unbiased and robust results, we need high-quality healthcare databases, rigorous study designs, and proper implementation of appropriate statistical methods. We aimed to describe opportunities and challenges in EHR-based CER for COVID-19-related questions and to introduce best practices in pharmacoepidemiology to minimize potential biases. We structured our discussion into the following topics: 1) Study population identification based on exposure status; 2) Ascertainment of outcomes; 3) Common biases and potential solutions; and 4) Data operational challenges specific to COVID-19 CER using EHR. We provide structured guidance for the proper conduct and appraisal of drug and vaccine effectiveness and safety research using EHR data for the pandemic. This manuscript is endorsed by the International Society for Pharmacoepidemiology (ISPE).

PMID:35170021 | DOI:10.1002/cpt.2560

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Nevin Manimala Statistics

The aftereffect of the ensemble average of facial expressions on subsequent facial expression recognition

Atten Percept Psychophys. 2022 Feb 15. doi: 10.3758/s13414-021-02407-w. Online ahead of print.

ABSTRACT

An ensemble or statistical summary can be extracted from facial expressions presented in different spatial locations simultaneously. However, how such complicated objects are represented in the mind is not clear. It is known that the aftereffect of facial expressions, in which prolonged viewing of facial expressions biases the perception of subsequent facial expressions of the same category, occurs only when a visual representation is formed. Using this methodology, we examined whether an ensemble can be represented with visualized information. Experiment 1 revealed that the presentation of multiple facial expressions biased the perception of subsequent facial expressions to less happy as much as the presentation of a single face did. Experiment 2 compared the presentation of faces comprising strong and weak intensities of emotional expressions with an individual face as the adaptation stimulus. The results indicated that the perceptual biases were found after the presentation of four faces and a strong single face, but not after the weak single face presentation. Experiment 3 employed angry expressions, a distinct category from the test expression used as an adaptation stimulus; no aftereffect was observed. Finally, Experiment 4 clearly demonstrated the perceptual bias with a higher number of faces. Altogether, these results indicate that an ensemble average extracted from multiple faces leads to the perceptual bias, and this effect is similar in terms of its properties to that of a single face. This supports the idea that an ensemble of faces is represented with visualized information as a single face.

PMID:35169990 | DOI:10.3758/s13414-021-02407-w

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Nevin Manimala Statistics

Mental Health Risk and Protective Factors of Nigerian Male Asylum Seekers Hosted in Southern Italy: a Culturally Sensitive Quantitative Investigation

J Racial Ethn Health Disparities. 2022 Feb 15. doi: 10.1007/s40615-022-01260-3. Online ahead of print.

ABSTRACT

This study provides a culturally sensitive quantitative investigation aimed at assessing the post-traumatic symptomatology, post-migratory difficulties, and resilience of 36 Nigerian male asylum seekers hosted in the province of Caserta, South Italy. A survey composed by the Harvard Trauma Questionnaire-Revised (HTQ-R), the Post-Migratory Checklist (PLMD), and the Connor-Davidson Resilience Scale (CD-RISC) was administered to participants. Descriptive and correlation analyses were made in order to describe the mental health risk and protective factors and understand the relation between these. A linear regression analysis was used to evaluate the influence of post-migratory difficulties and resilience on PTSD. Stratified bivariate analyses were also computed to detect PTSD group and no-PTSD group differences about post-migration difficulties and resilience levels. Regression analysis showed that PMLD numbers significantly increased the risk of having PTSD. No significant effect emerged for the level of resilience. Statistically significant differences between the PTSD group and non-PTSD group in relation to post-migratory difficulties were also found. No differences in the resilience factors emerged. The results offer a glimpse into a specific ethnic group of asylum seekers and its mental health risks and protective factors, taking into consideration the specificities of their past and current life-story experiences. Clinical implications for professionals working in the field of forced migration will be outlined.

PMID:35169994 | DOI:10.1007/s40615-022-01260-3

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Nevin Manimala Statistics

“Both a life saver and totally shameful”: young adult cancer survivors’ perceptions of medical crowdfunding

J Cancer Surviv. 2022 Feb 16. doi: 10.1007/s11764-022-01188-x. Online ahead of print.

ABSTRACT

PURPOSE: Young adults (YAs) diagnosed with cancer face high financial burden at a time in their lives when they are financially vulnerable. Some turn to medical crowdfunding, that is, using social media and other means to raise funds or resources to offset medical and usual life expenses. Major research gaps exist regarding the experiences of those who pursued crowdfunding. Thus, the study purpose was to describe the perceptions of, and experiences with, medical crowdfunding among a sample of YA cancer survivors.

METHODS: In February 2021, we distributed an online survey to YAs with a history of a cancer diagnosis, who had received grants from an organization that offers financial assistance. We calculated descriptive statistics on the crowdfunding sample and employed thematic analysis to analyze the open-ended questions.

RESULTS: In this sample (N = 113), 46 YA cancer survivors had engaged in medical crowdfunding and shared their perceptions and experiences. Our central theme, “The Crowdfunding Compromise” captures the trade-offs participants faced, which included subthemes of “crowdfunding as useful/helpful,” “factors associated with crowdfunding success,” and “questioning the why?”.

CONCLUSIONS: Among YA cancer survivors, medical crowdfunding brings shame and stigma in addition to financial support. YA cancer survivors demonstrate resilience in their attempts to find individual solutions to financial problems created by unchecked health care costs, the US health insurance infrastructure, and lack of legislation.

IMPLICATIONS FOR CANCER SURVIVORS: This study fills an important gap in understanding individual-level crowdfunding experiences. Implications include system-level approaches to addressing cancer-related financial burden and potential worsening of existing disparities through medical crowdfunding.

PMID:35169983 | DOI:10.1007/s11764-022-01188-x

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Nevin Manimala Statistics

Association between e-cigarette use and depression in US cancer survivors: a cross-sectional study

J Cancer Surviv. 2022 Feb 15. doi: 10.1007/s11764-022-01176-1. Online ahead of print.

ABSTRACT

PURPOSE: Though prior studies have observed significant association between e-cigarette use and mental health outcomes including depression in the general population, the relationship between e-cigarette use and clinical depression in the cancer survivor subpopulation is unknown. The purpose of this study was to examine the cross-sectional association between e-cigarette use and self-reported clinical depression among cancer survivors.

METHODS: Pooled data from the 2017 and 2018 Behavioral Risk Factor Surveillance Survey were used. Multivariable logistic regression was used to analyze the independent association between e-cigarette use and self-reported clinical depression in a sample of 7,498 cancer survivors.

RESULTS: Among cancer survivors in this study, 22.1% reported a history of clinical diagnosis of depression. The overall prevalence rates for current and former e-cigarette use were 2.6% and 10.5%, respectively. Analysis showed 51.3% of current users, 40% of former users, and 19.1% of those who had never used e-cigarettes self-reported a history of clinical depression. In the multivariable analysis, the odds of self-reported clinical depression were significantly higher for survivors who were current users (OR = 2.85; 95% CI: 1.38-5.90) and former users (OR = 1.63; 95% CI: 1.05-2.55) compared to never e-cigarette users.

CONCLUSION: Findings from this study suggest a statistically significant association between e-cigarette use and depression in cancer survivors. Future studies should focus on examining the longitudinal association between e-cigarette use and depression in cancer survivors.

IMPLICATIONS FOR CANCER SURVIVORS: Study findings reemphasized the need for interventions to support cancer survivors with evidence-based treatments for depression as well as the need for clinicians to screen for psychological distress and/or e-cigarette use and make appropriate recommendations.

PMID:35169981 | DOI:10.1007/s11764-022-01176-1

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Autologous Cultured Bone Marrow-Derived Mesenchymal Stem Cells in a Fibrin Spray to Treat Venous Ulcers: A Randomized Controlled Double-Blind Pilot Study

Surg Technol Int. 2022 Feb 16;40:sti40/1493. Online ahead of print.

ABSTRACT

We treated a small cohort of venous ulcers that were very unresponsive to standard and advanced therapies with autologous cultured bone marrow-derived mesenchymal stem cells (MSCs). This pilot clinical trial was randomized, controlled, and double-blinded. Subjects were treated with either normal saline (Group A), fibrin spray alone (Group B), or MSCs in fibrin (1 million cells/cm2 of wound bed surface) (Group C). The control and test materials were applied to the wound using a double-barreled syringe with thrombin and fibrinogen (with or without MSCs) in each barrel, or saline alone in both barrels. The MSCs were separated, cultured in vitro, and expanded in a dedicated Good Manufacturing Practice (GMP) facility from 30-50 ml of bone marrow aspirate obtained from the iliac crest in Group C subjects. To ensure that the study remained controlled and blinded, subjects who were randomized to one of the two control arms (saline or fibrin) underwent sham bone marrow aspiration performed by a hematologist who anesthetized the iliac crest area down to and pushing against the periosteum, but without penetrating the bone marrow. Therefore, both the clinician who evaluated wound progress and the study subjects had no knowledge of whether bone aspiration was actually performed and what treatment had been applied to the wound. The study was performed after full FDA investigational new drug (IND) approval. The primary endpoint was the rate of healing (wound closure as linear healing from the wound margins in cm/week), as measured by the Gilman equation. One-way ANOVA was used to calculate the statistical significance of differences between the mean healing rates of each of the 3 treatment groups every 4 weeks and over the 24 weeks of treatment. Overall, treatment with MSCs accelerated the healing rate by about 10-fold compared to those in the saline and fibrin control groups. Although the total number of patients in this pilot study was small (n=11), the statistical significance was surprisingly promising: p<0.01 and f-ratio of 15.9358. No serious adverse events were noted. This small but carefully performed prospective, controlled, randomized, and double-blinded pilot study in a rare population of totally unresponsive patients adds to previous reports showing the promise of MSCs in the treatment of chronic wounds and provides proof of principle for how to approach this type of very demanding clinical and translational research.

PMID:35168289

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Nevin Manimala Statistics

Differences in finished case quality between Invisalign and traditional fixed appliances

Angle Orthod. 2022 Mar 1;92(2):173-179. doi: 10.2319/032921-246.1.

ABSTRACT

OBJECTIVES: To compare the treatment and posttreatment effects of Invisalign aligners that incorporated SmartForce features and attachments to traditional fixed appliances.

MATERIALS AND METHODS: This randomized controlled trial included 66 patients, 32 aligners, and 34 fixed-appliance patients. The median ages of the aligner and braces patients were 26.7 (interquartile range [IQR]: 9.8) and 25.9 (IQR: 16.6) years, respectively. Pretreatment occlusion was assessed using the ABO Discrepancy Index. Posttreatment (T1) and 6-month retention (T2) occlusions were quantified using the ABO Objective Grading System (OGS) scores.

RESULTS: The braces group finished treatment significantly (P < .001) earlier (0.4 years) than the aligner group. The median DI scores for the aligner and braces groups were 4.5 and 7.0, respectively, which was a statistically significant (P = .015), but clinically insignificant, difference. There were no statistically significant between-group differences for the total OGS scores or any of the individual component scores at debond (T1) or after 6 months of retention (T2). During the posttreatment period, alignment and overjet worsened significantly in the aligner group, while buccolingual inclinations and occlusal relations improved. Over the same period, alignment worsened in the braces group and buccolingual inclinations improved. There was no statistically significant between-group difference in posttreatment changes of the total OGS scores.

CONCLUSIONS: While patients with simple malocclusions require 4.8 months longer treatment times with aligners than traditional braces, the treatment and 6-month posttreatment occlusal outcomes are similar.

PMID:35168256 | DOI:10.2319/032921-246.1