Tag: statistics

J Exp Orthop. 2022 Jul 10;9(1):67. doi: 10.1186/s40634-022-00503-w.

ABSTRACT

PURPOSE: Intraoperative wound irrigation prior to closure during total joint arthroplasty (TJA) is an essential component of preventing infections and limiting health care system costs. While studies have shown the efficacy of dilute betadine in reducing infection risk, there remains concerns over its safety profile and theoretical inactivation by blood and serum. This study aims to compare infection and wound complications between chlorhexidine gluconate (CHG) and betadine lavage during TJA.

METHODS: All primary TJA between 2019-2021 were analyzed at a single institution, and periprosthetic joint infection (PJI), wound drainage, 30 and 90-day emergency room (ER) readmission due to wound complications, aseptic loosening, and revision surgery rate were compared between patients undergoing intraoperative CHG versus betadine lavage prior to closure. Baseline demographics were controlled, and multivariate logistic regression was performed to compare complication rates.

RESULTS: A total of 410 TJA, including 160 hip and 250 knee arthroplasties were included. Compared to the dilute betadine cohort, all TJA patients undergoing CHG lavage had a statistically significant lower 30 and 90-day emergency room readmission rate due to wound complications. Both hip and knee arthroplasty patients with CHG had a statistically significant lower rate of postoperative superficial drainage and dressing saturation at clinic follow-up, but only knee arthroplasty patients had significant decreased readmission rate for incisional wound vacuum placement and close inpatient monitoring of wound healing. Among all TJA, there was no significant association in the rate of PJI requiring return to the OR between groups.

CONCLUSIONS: Although betadine is cost-effective and has been shown to reduce PJI rates, there remains concerns in the literature over soft tissue toxicity and wound healing. This study suggests CHG may be as efficacious as dilute betadine in preventing PJI while also decreasing the risk of superficial drainage and wound complications needing unplanned ER visits during the acute postoperative period.

PMID:35819733 | DOI:10.1186/s40634-022-00503-w

Neurotherapeutics. 2022 Jul 11. doi: 10.1007/s13311-022-01271-2. Online ahead of print.

ABSTRACT

Thoughtful clinical trial design is critical for efficient therapeutic development, particularly in the field of amyotrophic lateral sclerosis (ALS), where trials often aim to detect modest treatment effects among a population with heterogeneous disease progression. Appropriate outcome measure selection is necessary for trials to provide decisive and informative results. Investigators must consider the outcome measure’s reliability, responsiveness to detect change when change has actually occurred, clinical relevance, and psychometric performance. ALS clinical trials can also be performed more efficiently by utilizing statistical enrichment techniques. Innovations in ALS prediction models allow for selection of participants with less heterogeneity in disease progression rates without requiring a lead-in period, or participants can be stratified according to predicted progression. Statistical enrichment can reduce the needed sample size and improve study power, but investigators must find a balance between optimizing statistical efficiency and retaining generalizability of study findings to the broader ALS population. Additional progress is still needed for biomarker development and validation to confirm target engagement in ALS treatment trials. Selection of an appropriate biofluid biomarker depends on the treatment mechanism of interest, and biomarker studies should be incorporated into early phase trials. Inclusion of patients with ALS as advisors and advocates can strengthen clinical trial design and study retention, but more engagement efforts are needed to improve diversity and equity in ALS research studies. Another challenge for ALS therapeutic development is identifying ways to respect patient autonomy and improve access to experimental treatment, something that is strongly desired by many patients with ALS and ALS advocacy organizations. Expanded access programs that run concurrently to well-designed and adequately powered randomized controlled trials may provide an opportunity to broaden access to promising therapeutics without compromising scientific integrity or rushing regulatory approval of therapies without adequate proof of efficacy.

PMID:35819713 | DOI:10.1007/s13311-022-01271-2

Int J Behav Med. 2022 Jul 11. doi: 10.1007/s12529-022-10113-6. Online ahead of print.

ABSTRACT

BACKGROUND: High sedentary time (ST) and low physical activity may increase cardiovascular risk, potentially though cardiac-autonomic dysregulation. This study investigated associations of statistically exchanging device-measured ST and physical activity with measures of cardiac-autonomic regulation in previously pregnant women.

METHOD: This cross-sectional, secondary analysis included 286 women (age = 32.6 ± 5.7 years; 68% white) measured 7-15 years after delivery. ST and light (LPA), moderate (MPA), vigorous (VPA), and moderate-to-vigorous (MVPA) intensity physical activity were measured by ActiGraph GT3X. ST was further partitioned into long (≥ 30 min) and short (< 30 min) bouts. MVPA was also partitioned into long (≥ 10 min) and short (< 10 min) bouts. Cardiac-autonomic regulation was assessed by heart rate variability (HRV) (resting heart rate, natural log transformed standard deviation of normal R-R intervals [lnSDNN], natural log-transformed root mean square of successive differences [lnRMSSD]) from a 5-min seated ECG. Progressive isotemporal substitution models adjusted for confounders. Sensitivity analyses removed women with related underlying medical conditions and who did not meet respiration rate criteria.

RESULTS: Initial analyses found no significant associations with HRV when exchanging 30 min of ST and physical activity (p > 0.05). Yet, replacing long- and short-bout ST with 30 min of long-bout MVPA yielded significantly higher (healthier) lnRMSSD (B = 0.063 ± 0.030 and B = 0.056 ± 0.027, respectively; both p < 0.05). Sensitivity analyses strengthened these associations and yielded further associations of higher lnSDNN and lnRMSSD when replacing 30 min of short-bout MVPA with equivalent amounts of long-bout MVPA (B = 0.074 ± 0.037 and B = 0.091 ± 0.046, respectively).

CONCLUSION: Replacing ST with long-bout MVPA is a potential strategy to improve cardiac-autonomic function in previously pregnant women.

PMID:35819720 | DOI:10.1007/s12529-022-10113-6

Indian J Pediatr. 2022 Jul 12. doi: 10.1007/s12098-022-04285-y. Online ahead of print.

NO ABSTRACT

PMID:35819703 | DOI:10.1007/s12098-022-04285-y

Rice (N Y). 2022 Jul 12;15(1):37. doi: 10.1186/s12284-022-00582-4.

ABSTRACT

Being one of the most important staple dietary constituents globally, genetic enhancement of cultivated rice for yield, agronomically important traits is of substantial importance. Even though the climatic factors and crop management practices impact complex traits like yield immensely, the contribution of variation by underlying genetic factors surpasses them all. Previous studies have highlighted the importance of utilizing exotic germplasm, landraces in enhancing the diversity of gene pool, leading to better selections and thus superior cultivars. Thus, to fully exploit the potential of progenitor of Asian cultivated rice for productivity related traits, genome wide association study (GWAS) for seven agronomically important traits was conducted on a panel of 346 O. rufipogon accessions using a set of 15,083 high-quality single nucleotide polymorphic markers. The phenotypic data analysis indicated large continuous variation for all the traits under study, with a significant negative correlation observed between grain parameters and agronomic parameters like plant height, culm thickness. The presence of 74.28% admixtures in the panel as revealed by investigating population structure indicated the panel to be very poorly genetically differentiated, with rapid LD decay. The genome-wide association analyses revealed a total of 47 strong MTAs with 19 SNPs located in/close to previously reported QTL/genic regions providing a positive analytic proof for our studies. The allelic differences of significant MTAs were found to be statistically significant at 34 genomic regions. A total of 51 O. rufipogon accessions harboured combination of superior alleles and thus serve as potential candidates for accelerating rice breeding programs. The present study identified 27 novel SNPs to be significantly associated with different traits. Allelic differences between cultivated and wild rice at significant MTAs determined superior alleles to be absent at 12 positions implying substantial scope of improvement by their targeted introgression into cultivars. Introgression of novel significant genomic regions into breeder’s pool would broaden the genetic base of cultivated rice, thus making the crop more resilient.

PMID:35819660 | DOI:10.1186/s12284-022-00582-4

Clin Rheumatol. 2022 Jul 11. doi: 10.1007/s10067-022-06283-z. Online ahead of print.

ABSTRACT

Intestinal pseudo-obstruction (IPO) is a rare gastrointestinal complication of systemic lupus erythematosus (SLE). We aimed to determine the prevalence and in-hospital outcomes of SLE-related intestinal pseudo-obstruction (SLE-IPO) using a large national database. This is a retrospective study using Nationwide Inpatient Sample (NIS) from 2016 to 2018. We included adult patients with SLE using International Classification of Diseases 10th Revision (ICD-10) code M32 in combination with codes for IPO, and we determined the in-hospital mortality, occurrence of sepsis, length of hospitalization, use of total parenteral nutrition (TPN), and frequency of surgical gastrointestinal procedures. The prevalence of IPO among hospitalized adult SLE patients was 1.7%, and the in-hospital mortality of SLE-IPO was 5.04%. Compared with SLE patients without IPO (group 2), SLE-IPO patients had higher in-hospital mortality (OR 2.07, 95%CI 1.60-2.64), higher risk of sepsis (OR 1.63, 95%CI 1.42-1.87), longer in-hospital stay (β 3.09, 95%CI 2.76-3.42), and higher frequency of TPN (OR 16.20, 95%CI 11.62-22.21) and gastrointestinal procedures (OR 5.47, 95%CI 4.62-6.43). SLE-IPO was associated with increased risk of sepsis (OR 1.29, 95%CI 1.12-1.49), compared with idiopathic IPO patients (group 3), and a possible increase in the frequency of gastrointestinal procedures (OR 1.14, 95%CI 0.96-1.34) compared with IPO secondary to diabetes mellitus (group 4), although not statistically significant. SLE-IPO patients were at twofold risk of in-hospital mortality compared with SLE patients without IPO. SLE-IPO was also associated with longer in-hospital stay and increased frequency of TPN and gastrointestinal procedures. Key Points • The prevalence of IPO in adult SLE patients was 1.7% in this US-based database. • In-hospital mortality rate of SLE-IPO was 4.95%. SLE-IPO patients were associated with twofold risk of in-hospital mortality compared with those without IPO. • SLE-IPO patients were also at increased risk of sepsis, and they had higher rate of TPN and gastrointestinal procedures.

PMID:35819642 | DOI:10.1007/s10067-022-06283-z

Can J Anaesth. 2022 Jul 12. doi: 10.1007/s12630-022-02279-0. Online ahead of print.

ABSTRACT

PURPOSE: Peripheral nerve blocks improve analgesia following hip fracture; however, there are little published data on safety and outcomes of continuous regional anesthetic techniques. Our institution offers pre- and perioperative, anesthesiologist-delivered ultrasound-guided suprainguinal fascia iliaca catheters (FICs) to patients with hip fracture. We aimed to document the safety profile of this technique and establish whether there are any significant clinical benefits in outcomes measured by the UK National Hip Fracture Database.

METHODS: We performed a single-centre historical cohort study of 2,187 patients admitted to our institution with hip fracture over a 5.75-year period. Of these, 915 were treated with FIC and 1,272 received standard care (single-shot block). To control for baseline differences between these two cohorts, we used propensity score matching and exact matching, resulting in two well-matched groups of 728 patients treated with an FIC and standard care.

RESULTS: No serious complications were observed as a result of an FIC. Unplanned removal occurred in 146/852 (17.1%) patients with documented data. No differences in 30-day mortality, pressure ulcer rates, or hospital length of stay were observed between the matched groups. The percentage of patients who were discharged to their usual residence was 79.3% in the FIC cohort vs 75.1% in the standard care cohort (difference, 4.2%; 95% confidence interval, -0.1 to 8.4; P = 0.06).

DISCUSSION: Our single-centre propensity-matched historical cohort study suggests that ultrasound-guided suprainguinal fascia iliaca catheterization is a safe technique for patients with hip fracture and that our service is deliverable and sustainable within the UK’s National Health Service. This study did not show statistically significant differences in outcomes between patients treated with FIC and standard care. An adequately powered multicentre randomized controlled trial comparing these approaches is warranted.

PMID:35819630 | DOI:10.1007/s12630-022-02279-0

Ann Nucl Med. 2022 Jul 11. doi: 10.1007/s12149-022-01767-z. Online ahead of print.

ABSTRACT

OBJECTIVE: The Oncotype DX (ODX) estimates the 10-year risk of metastasis or recurrence of breast cancer and indicates whether chemotherapy is likely to be effective; however, the high cost of this test may limit its use for patients. The aim of this study was to evaluate the potential of preoperative imaging using mammography (MMG), ultrasonography (US), and dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI), and positron emission tomography/computed tomography (PET/CT) metabolic parameters in predicting the ODX recurrence score (ODXRS), which prognosticates estrogen receptor-positive (ER +)/human epidermal growth factor receptor 2-negative (HER2-) breast cancer.

METHODS: This retrospective study was conducted on 51 patients with ER+/ HER2- early-stage breast cancer with preoperative images available. Surgical specimens were sent for ODX assay and the ODXRS was categorized as low (<18) or intermediate/high (≥18). MMG/US findings were classified according to BI-RADS categories. For MRI analysis, tumor growth orientation was evaluated in addition to morphological assessment in BI-RADS. For PET/CT analysis, standardized uptake value (SUV) of the tumor were measured. Patient, tumor, and image characteristics were compared between the two groups, and predictors of the low ODXRS group were determined by logistic regression analysis. Two-sided P values less than 0.05 were considered statistically significant.

RESULTS: Thirty-two (63%) and 19 (37%) patients were categorized as low and intermediate/high ODXRS, respectively. On univariate analysis, nuclear grade, tumor margin, and tumor growth orientation on MRI, and SUV_max on PET/CT were significantly associated with a low ODXRS. Multivariate analysis revealed that tumor growth orientation perpendicular to the Cooper’s ligament on MRI (P = 0.031) and a low SUV_max on PET/CT (P = 0.016) were independent prognostic factors for a low ODXRS. As a predictor of low ODXRS, the receiver operating characteristic (ROC) analysis of the SUV_max showed that using 3.0 as the optimal cut-off value has a sensitivity and specificity of 94.4% and 73.0%, respectively, with an area under the curve (AUC) of 0.923.

CONCLUSIONS: The combination of perpendicular tumor growth orientation to Cooper’s ligaments on MRI and a low SUV_max on PET/CT may predict a low ODXRS.

PMID:35819628 | DOI:10.1007/s12149-022-01767-z

Vet Surg. 2022 Jul 12. doi: 10.1111/vsu.13851. Online ahead of print.

ABSTRACT

OBJECTIVE: To describe the transoral endoscopic arytenopexy (TEA) and evaluate its effects on the rima glottis area (RGA) and laryngeal epiglottic-glottic seal (LEGS). We hypothesize the TEA will be a feasible surgical technique and the TEA will provide a significant increase in RGA with minimal change to the LEGS.

STUDY DESIGN: Canine cadaveric model.

ANIMALS: Fifteen medium- to large-breed canine cadavers.

METHODS: Endoscopic photos of the larynx were taken with the epiglottis open for baseline RGA measurement and closed for baseline measurement of exposed RGA and LEGS. A custom endoscopic gag port (EGP) facilitated the TEA, performed by suturing the lateral aspect of the left arytenoid soft tissues to adjacent pharyngeal wall across the piriform recess. Endoscopic photos were repeated to measure changes in RGA and LEGS. A computerized planimetric analysis program was used to calculate baseline RGA and LEGS. The RGA was reported in % change from baseline. The LEGS was reported as intact or altered. A nonparametric Wilcoxon signed-rank test was used to compare baseline to post-TEA RGA.

RESULTS: The mean baseline RGA was 0.52 ± 0.28 cm³ and mean post-TEA RGA was 0.78 ± 0.37 cm³ (p-value < .0001). The LEGS remained intact post-TEA in all cadavers.

CONCLUSIONS: The TEA was technically feasible and resulted in an increase in RGA while maintaining the LEGS.

CLINICAL SIGNIFICANCE: The TEA may provide a minimally invasive addition to the established techniques for reducing airway resistance while minimizing the impact on the LEGS.

PMID:35819626 | DOI:10.1111/vsu.13851

Bioinformatics. 2022 Jul 12:btac451. doi: 10.1093/bioinformatics/btac451. Online ahead of print.

ABSTRACT

MOTIVATION: In this paper we consider how to evaluate survival distribution predictions with measures of discrimination. This is non-trivial as discrimination measures are the most commonly used in survival analysis and yet there is no clear method to derive a risk prediction from a distribution prediction. We survey methods proposed in literature and software and consider their respective advantages and disadvantages.

RESULTS: Whilst distributions are frequently evaluated by discrimination measures, we find that the method for doing so is rarely described in the literature and often leads to unfair comparisons or ‘C-hacking’. We demonstrate by example how simple it can be to manipulate results and use this to argue for better reporting guidelines and transparency in the literature. We recommend that machine learning survival analysis software implements clear transformations between distribution and risk predictions in order to allow more transparent and accessible model evaluation.

AVAILABILITY: The code used in the final experiment is available at https://github.com/RaphaelS1/distribution_discrimination.

SUPPLEMENTARY INFORMATION: Supplementary data are available at Bioinformatics online.

PMID:35818973 | DOI:10.1093/bioinformatics/btac451