Tag: statistics

Am J Clin Pathol. 2021 Sep 14:aqab133. doi: 10.1093/ajcp/aqab133. Online ahead of print.

ABSTRACT

OBJECTIVES: Rituximab (RTX) is associated with variable adverse gastrointestinal (GI) events. However, the histologic correlate in affected patients is not well defined.

METHODS: Patients (n = 93) who had received RTX and undergone endoscopic biopsies were identified. CD20 and PAX5 immunostains were performed on biopsy specimens showing inflammatory pathology (group A, 36 patients) and 35 of 57 noninflammatory biopsies (group B) that were taken within 1 year from the last RTX infusion. Histologic findings were correlated with tissue B-cell depletion (CD20/PAX5-/-).

RESULTS: B cells were depleted in 12 (33%) of 36 group A biopsy specimens. After excluding biopsies taken more than 1 year from the last RTX infusion, the frequencies of tissue B-cell depletion were similar between group A (12/26; 46.2%) and group B (17/35; 48.6%) (P > .05). Also, the frequencies of inflammatory pathology were not statistically different whether B cells were depleted or not (P > .05). In group A with tissue B-cell depletion (n = 12), causality was indicated in two (17%) cases showing lymphocytic colitis pattern of injury (LCPI).

CONCLUSIONS: In RTX-treated patients, tissue B-cell depletion does not appear to be the main cause of inflammatory pathology in the GI tract. A minor subset, however, develops histologic evidence of potential RTX-induced effect, notably in the form of LCPI.

PMID:34520518 | DOI:10.1093/ajcp/aqab133

PLoS One. 2021 Sep 14;16(9):e0257315. doi: 10.1371/journal.pone.0257315. eCollection 2021.

ABSTRACT

PURPOSE: The present study evaluated changes in bone tracer uptake (BTU) after medial open-wedge high tibial osteotomy (MOWHTO) and determined whether postoperative BTU correlates with clinical symptoms, radiologic parameters, or cartilage regeneration following MOWHTO.

METHODS: A total of 210 knees underwent MOWHTO for medial compartmental osteoarthritis (OA) were enrolled in this study. Mean follow-up period was 42.7 months. We assessed BTU for the medial compartment of the knee before MOWHTO and at the time of plate removal. Radiologic parameters included Kellgren-Lawrence (K-L) grade and Hip-Knee-Ankle angle (HKAA). Clinical evaluation included American Knee Society (AKS) score and cartilage status was graded at the time of MOWHTO and second-look arthroscopy according to the International Cartilage Repair Society (ICRS) grading system and articular cartilage regeneration stage. Statistical analysis performed to assess the relationships among postoperative BTU of the medial compartment, radiologic parameters, arthroscopic changes and clinical outcomes.

RESULTS: BTU of medial femoral condyle and tibial plateau were significantly decreased at 2 years after MOWHTO (p<0.001). AKS scores and arthroscopic cartilage status were also significantly improved following MOWHTO. BMI and postoperative HKAA showed significant correlations with postoperative changes of BTU in uni- and multi-variable analysis. Meanwhile, postoperative changes of BTU did not show significant correlation with clinical outcomes or cartilage regeneration following MOWHTO.

CONCLUSION: Lower BMI and postoperative valgus alignment were significant predictor for postoperative BTU decrease of the medial compartment following MOWHTO. However, postoperative changes of BTU did not reflect cartilage regeneration or clinical outcomes until the midterm follow-up.

PMID:34520482 | DOI:10.1371/journal.pone.0257315

PLoS One. 2021 Sep 14;16(9):e0256903. doi: 10.1371/journal.pone.0256903. eCollection 2021.

ABSTRACT

INTRODUCTION: During COVID-19 pandemic, the use of several drugs has represented the worldwide clinical practice. However, though the current increase of knowledge about the disease, there is still no effective treatment for the usage of drugs. Thus, we retrospectively assessed use and effects of therapeutic regimens in hospitalized patients on in-hospital mortality.

METHODS: COVOCA is a retrospective observational cohort study on 18 COVID centres throughout Campania Region Hospitals. We included adult patients with confirmed SARS-CoV-2 infection, discharged/dead between March/June 2020.

RESULTS: 618 patients were included, with an overall in-hospital cumulative mortality incidence of 23.1%. Most prescribed early treatments were antivirals (72%), antibiotics (65%) and hydroxychloroquine/anticoagulants (≈50%). Tocilizumab, indeed, was largely prescribed late during hospitalization. Multivariable models, with a cut-off at day 2 for early COVID-19 therapy administration, did not disclose any significant association of a single drug administration on the clinical outcome.

DISCUSSION: COVOCA represents the first multicenter database in Campania region. None drug class used during the pandemic significantly modified the outcome, regardless of therapy beginning, both overall and net of those already in non-invasive ventilation (NIV)/ orotracheal intubation (OTI) at hospitalization. Our cumulative incidence of mortality seems lower than other described during the same period, particularly in Northern Italy.

PMID:34520465 | DOI:10.1371/journal.pone.0256903

PLoS One. 2021 Sep 14;16(9):e0255340. doi: 10.1371/journal.pone.0255340. eCollection 2021.

ABSTRACT

OBJECTIVE: This study aimed to assess the prevalence and associated factors of post-traumatic stress disorder among health professionals working in South Gondar Zone hospitals in the era of the COVID-19 pandemic, Amhara Ethiopia 2020.

METHODS: Institutional based cross-sectional study design was conducted. A total of 396 respondents completed the questionnaire and were included in the analysis. A previously adapted self-administered pretested standard questionnaire, Impact of Event Scale-Revised (IES-R-22) was used to measure post-traumatic stress disorder. Data was entered into Epi data version 4.4.2 then exported to SPSS version 24 for analysis. Descriptive and analytical statistical procedures, bivariate, and multivariate binary logistic regressions with odds ratios and 95% confidence interval were employed. The level of significance of association was determined at a p-value < 0.05.

RESULTS: The prevalence of post-traumatic stress disorder among health care providers in this study was 55.1% (95% CI: 50.3, 59.6). Lack of standardized PPE supply (AOR = 2.5 7,95CI;1.37,4.85), respondents age > 40 years (AOR = 3.95, 95CI; 1.74, 8.98), having medical illness (AOR = 4.65, 95CI;1.65,13.12), perceived stigma (AOR = 1.97, 95CI;1.01, 3.85), history of mental illness(AOR = 8.08,95IC;2.18,29.98) and having poor social support (AOR = 4.41,95CI;2.65,7.3) were significantly associated with post-traumatic stress disorder at p-value < 0.05. Conversely, being a physician (AOR = 0.15, 95CI; 0.04, 0.56) was less affected by PTSD.

CONCLUSIONS: The prevalence of post-traumatic stress disorder among health care providers in this study was high. Adequate and standardized PPE supply, giving especial emphasis to those care providers with medical illness, history of mental illness, and having poor social support, creating awareness in the community to avoid the stigma faced by health care providers who treat COVID patients is recommended.

PMID:34520471 | DOI:10.1371/journal.pone.0255340

J Orthop Trauma. 2021 Sep 14. doi: 10.1097/BOT.0000000000002271. Online ahead of print.

ABSTRACT

OBJECTIVES: The goals of this study were to investigate trends in the timing to femur fracture fixation in trauma centers in the United States, identify predictors for delayed treatment, and analyze the association of timing to fixation with in-hospital morbidity and mortality using data from the National Trauma Data Bank (NTDB).

METHODS: Patients with femoral shaft fractures treated from 2007-2015 were identified from the NTDB, and grouped by timing of femur fixation: <24 hours, 24-48 hours, and >48 hours after hospital presentation. The primary outcome measure was in-hospital postoperative mortality rate. Secondary outcomes included complication rates, length of hospital stay (LOS), days spent in the intensive care unit (ICU LOS), and days on a ventilator.

RESULTS: Among the 108,825 unilateral femoral shaft fractures identified, 74.2% were fixed within 24 hours, 16.5% between 24-48 hours, and 9.4% >48 hours. The mortality rate was 1.6% overall for the group. When fixation was delayed >48 hours, patients were at risk of significantly higher mortality rate (OR 3.60; 95% confidence interval [CI], 3.13-4.14), longer LOS (OR 2.14; CI 2.06-2.22), longer ICU LOS (OR 3.92; CI 3.66-4.20), more days on a ventilator (OR 5.38; CI 4.89-5.91), and more postoperative complications (OR 2.05; CI 1.94-2.17; p<0.0001).

CONCLUSIONS: Our study confirms that delayed fixation of femoral shaft fractures is associated with increased patient morbidity and mortality. Patients who underwent fixation >48 hours after presentation were at the greatest risk for increased morbidity and mortality. Although some patients require optimization/resuscitation prior to fracture fixation, efforts should be made to expedite operative fixation.

LEVEL OF EVIDENCE: Prognostic Level III. See Instructions for Authors for a complete description of levels of evidence.

PMID:34520446 | DOI:10.1097/BOT.0000000000002271

PLoS Med. 2021 Sep 14;18(9):e1003738. doi: 10.1371/journal.pmed.1003738. eCollection 2021 Sep.

ABSTRACT

BACKGROUND: Tuberculosis (TB) preventive therapy (TPT) is an essential component of care for people living with HIV (PLHIV). We compared efficacy, safety, completion, and drug-resistant TB risk for currently recommended TPT regimens through a systematic review and network meta-analysis (NMA) of randomized trials.

METHODS AND FINDINGS: We searched MEDLINE, Embase, and the Cochrane Library from inception through June 9, 2020 for randomized controlled trials (RCTs) comparing 2 or more TPT regimens (or placebo/no treatment) in PLHIV. Two independent reviewers evaluated eligibility, extracted data, and assessed the risk of bias. We grouped TPT strategies as follows: placebo/no treatment, 6 to 12 months of isoniazid, 24 to 72 months of isoniazid, and rifamycin-containing regimens. A frequentist NMA (using graph theory) was carried out for the outcomes of development of TB disease, all-cause mortality, and grade 3 or worse hepatotoxicity. For other outcomes, graphical descriptions or traditional pairwise meta-analyses were carried out as appropriate. The potential role of confounding variables for TB disease and all-cause mortality was assessed through stratified analyses. A total of 6,466 unique studies were screened, and 157 full texts were assessed for eligibility. Of these, 20 studies (reporting 16 randomized trials) were included. The median sample size was 616 (interquartile range [IQR], 317 to 1,892). Eight were conducted in Africa, 3 in Europe, 3 in the Americas, and 2 included sites in multiple continents. According to the NMA, 6 to 12 months of isoniazid were no more efficacious in preventing microbiologically confirmed TB than rifamycin-containing regimens (incidence rate ratio [IRR] 1.0, 95% CI 0.8 to 1.4, p = 0.8); however, 6 to 12 months of isoniazid were associated with a higher incidence of all-cause mortality (IRR 1.6, 95% CI 1.2 to 2.0, p = 0.02) and a higher risk of grade 3 or higher hepatotoxicity (risk difference [RD] 8.9, 95% CI 2.8 to 14.9, p = 0.004). Finally, shorter regimens were associated with higher completion rates relative to longer regimens, and we did not find statistically significant differences in the risk of drug-resistant TB between regimens. Study limitations include potential confounding due to differences in posttreatment follow-up time and TB incidence in the study setting on the estimates of incidence of TB or all-cause mortality, as well as an underrepresentation of pregnant women and children.

CONCLUSIONS: Rifamycin-containing regimens appear safer and at least as effective as isoniazid regimens in preventing TB and death and should be considered part of routine care in PLHIV. Knowledge gaps remain as to which specific rifamycin-containing regimen provides the optimal balance of efficacy, completion, and safety.

PMID:34520459 | DOI:10.1371/journal.pmed.1003738

Int J Lang Commun Disord. 2021 Sep 14. doi: 10.1111/1460-6984.12670. Online ahead of print.

ABSTRACT

BACKGROUND: Simulation-based learning can be used in university programmes to provide speech-language pathology students with essential clinical experiences. However, limited research has explored the use of simulation to support students’ development of skills in clinical practice with people who stutter.

AIMS: (1) To evaluate students’ clinical skills in managing stuttering within a simulation-based learning programme; (2) to develop an assessment tool, the Standardised Patient Interview Rating Scale for Stuttering (SPIRS-Stuttering); and (3) to conduct a preliminary investigation of its validity in measuring students’ performance.

METHODS & PROCEDURES: Speech-language pathology students (n = 114) participated in a simulation-based stuttering programme in addition to academic coursework in fluency disorders. Students’ clinical skills were assessed over two simulation sessions using the SPIRS-Stuttering tool, adapted from an earlier iteration of the SPIRS tool. Content validity, intra-rater reliability and internal consistency of the SPIRS-Stuttering tool were also explored.

OUTCOMES & RESULTS: Students demonstrated a statistically significant improvement in stuttering clinical skills between sessions 1 and 4 of the simulation-based stuttering programme. Good content validity was achieved for the SPIRS-Stuttering tool with a low level of intra-rater reliability and variable internal consistency.

CONCLUSIONS & IMPLICATIONS: This study identified that students’ clinical skills in stuttering improved during participation in a simulation-based programme undertaken in conjunction with an academic course on fluency disorders. The results of this study support the inclusion of this learning modality in university programme curricula. Whilst the SPIRS-Stuttering tool enabled assessment of speech-language pathology students’ clinical skills in stuttering management, further exploration of reliability is required.

WHAT THIS PAPER ADDS: What is already known on this subject Within speech-language pathology, simulation-based learning is a teaching approach used in university clinical programme curricula. Simulation-based learning is used as an opportunity for students to gain specific clinical skills, particularly if clinical experiences are readily not available. Research in speech-language pathology has revealed that students value simulation because it provides a safe learning environment. What this study adds to existing knowledge There are fewer opportunities for students to gain clinical experience in the management of stuttering in adults. This study explored students’ clinical skill development within a stuttering simulation-based learning programme. Additionally, it detailed the development and preliminary investigation of validity of the SPIRS-Stuttering, an assessment tool used in a simulation-based learning environment. What are the potential or actual clinical implications of this work? Students’ clinical skills in the assessment and management of stuttering in adults, as measured by the SPIRS-Stuttering, improved during participation in the stuttering simulation-based learning programme. Further investigation of validity of the SPIRS-Stuttering tool is required to confidently measure students’ performance. The stuttering simulation-based learning programme can be used to provide students with an opportunity to develop their clinical skills in stuttering, a practice area in speech-language pathology that is not always available to students.

PMID:34519389 | DOI:10.1111/1460-6984.12670

Pediatr Blood Cancer. 2021 Sep 14:e29342. doi: 10.1002/pbc.29342. Online ahead of print.

ABSTRACT

BACKGROUND: Integratedbehavioral health models have been proposed as care delivery approaches to mitigate mental health disparities in primary care settings. However, these models have not yet been widely adopted or evaluated in pediatric oncology medical homes.

METHODS: We conducted a retrospective cohort study of 394 children with newly diagnosed cancer at Dana-Farber/Boston Children’s Cancer and Blood Disorders Center (DF/BCH) from April 2013 to January 2017. Baseline sociodemographic characteristics and psychiatry utilization outcomes at 12 months following diagnosis were abstracted from the medical record. The severity of household material hardship (HMH), a concrete poverty exposure, at diagnosis and race/ethnicity were characterized by parent report using the Psychosocial Assessment Tool 2.0 (PAT). Associations between sociodemographic characteristics and receipt of psychiatry consultation were assessed with multivariable logistic regression models.

RESULTS: Among 394 children, 29% received a psychiatric consultation within 12 months postdiagnosis. Of these, 88% received a new psychiatric diagnosis, 76% received a psychopharmacologic recommendation, and 62% received a new behavioral intervention recommendation. In multivariable logistic regression adjusting for age, cancer diagnosis, and PAT total score, there was no statistically significant association between HMH severity or household income and psychiatry utilization. Children who identified as racial/ethnic minorities were significantly less likely to receive a psychiatry consultation (OR = 0.48, 95% CI = 0.27-0.84).

CONCLUSIONS: In a pediatric oncology medical home with an integrated behavioral health model, socioeconomic status was not associated with disparate psychiatry utilization. However, there remained a profound racial/ethnic disparity in psychiatry utilization, highlighting the need for additional research and care delivery intervention.

PMID:34519425 | DOI:10.1002/pbc.29342

Clin Infect Dis. 2021 Sep 14:ciab787. doi: 10.1093/cid/ciab787. Online ahead of print.

ABSTRACT

BACKGROUND: Annual mass drug administration (MDA) using praziquantel is the cornerstone of schistosomiasis morbidity control, but is not sufficient to interrupt transmission. We implemented a cluster-randomized trial to compare the effectiveness of four different intervention packages to interrupt transmission of Schistosoma haematobium in a seasonal transmission setting of Côte d’Ivoire.

METHODS: Sixty-four localities with a S. haematobium prevalence in school children aged 13-14 years above 4% were randomly assigned to one of four intervention arms over a 3-year period: (1) the current standard strategy consisting of annual MDA before peak of transmission; (2) annual MDA after peak of transmission; (3) biannual MDA; and (4) standard MDA combined with snail control. The primary outcome was prevalence and intensity of S. haematobium infection in children aged 9-12 years 1 year after the final intervention, using urine filtration performed by experienced microscopists.

RESULTS: By study end, we observed the lowest S. haematobium prevalence in the biannual MDA, compared to the standard treatment arm (0.6% vs. 7.5%; odds ratio [OR] = 0.07, 95% confidence interval [CI] = 0.02 to 0.24). The prevalence in arms 2 and 4 was about 3.5%, which was not statistically significantly different from the standard strategy (both ORs 0.4, 95% CI = 0.1 to ~1.8). New cases of infection were still observed in all arms at study end.

CONCLUSIONS: Biannual MDA was the only regimen that outperformed the standard treatment. All strategies resulted in decreased prevalence of infection, however none of them was able to interrupt transmission of S. haematobium within a 3-year period.

PMID:34519344 | DOI:10.1093/cid/ciab787

Hum Brain Mapp. 2021 Sep 14. doi: 10.1002/hbm.25577. Online ahead of print.

ABSTRACT

Many key findings in neuroimaging studies involve similarities between brain maps, but statistical methods used to measure these findings have varied. Current state-of-the-art methods involve comparing observed group-level brain maps (after averaging intensities at each image location across multiple subjects) against spatial null models of these group-level maps. However, these methods typically make strong and potentially unrealistic statistical assumptions, such as covariance stationarity. To address these issues, in this article we propose using subject-level data and a classical permutation testing framework to test and assess similarities between brain maps. Our method is comparable to traditional permutation tests in that it involves randomly permuting subjects to generate a null distribution of intermodal correspondence statistics, which we compare to an observed statistic to estimate a p-value. We apply and compare our method in simulated and real neuroimaging data from the Philadelphia Neurodevelopmental Cohort. We show that our method performs well for detecting relationships between modalities known to be strongly related (cortical thickness and sulcal depth), and it is conservative when an association would not be expected (cortical thickness and activation on the n-back working memory task). Notably, our method is the most flexible and reliable for localizing intermodal relationships within subregions of the brain and allows for generalizable statistical inference.

PMID:34519385 | DOI:10.1002/hbm.25577