Category: Statistics

Med Princ Pract. 2022 Feb 16. doi: 10.1159/000522626. Online ahead of print.

ABSTRACT

OBJECTIVE: While SARS-CoV-2 primarily affects lung tissue, it may cause direct or indirect damage to the cardiovascular system and permanent damage may occur. Arterial stiffness is an early indicator of cardiovascular disease risk. The aim of our study was to establish the potential effects of SARS-CoV-2 on the vascular system evaluated by transthoracic echocardiographic (TTE) examination.

SUBJECTS AND METHODS: This study compared arterial stiffness between the survivors of COVID-19 and those without a history of COVID-19 infection. The difference in aortic diameter was examined using echocardiography.

RESULTS: The study included 50 patients who survived COVID-19 in the last 3 to 6 months and 50 age- and gender-matched healthy volunteers. In surviving COVID-19 patients, aortic diastolic diameter in cm ([3.1±0.2] vs. [2.9±0.1], p < 0.001), pulse pressure ([43.02±14.05] vs [35.74±9.86], p = 0.004), aortic distensibility ([5.61±3.57] vs [8.31±3.82], p < 0.001), aortic strain ([10.56±4.91] vs [13.88±5.86], p = 0.003), pulse pressure/stroke volume index ([1.25±0.47] vs [0.98±0.28], p = 0.001) and aortic stiffness index ([2.82±0.47] vs [2.46±0.45], p < 0.001) were statistically significant compared to the control group.

CONCLUSION: SARS-CoV-2 may cause reduced or impaired aortic elasticity parameters linked to impaired arterial wall function in COVID-19 survivors compared with controls.

PMID:35172305 | DOI:10.1159/000522626

Eur J Cancer. 2022 Feb 13;164:39-51. doi: 10.1016/j.ejca.2021.12.030. Online ahead of print.

ABSTRACT

BACKGROUND: Biomarkers for cyclin-dependent kinase 4/6 inhibitors, such as palbociclib, for patients with hormone receptor-positive/HER2-negative metastatic breast cancer are lacking. Thymidine kinase is a proliferation marker downstream of the cyclin-dependent kinase 4/6 pathway. We prospectively investigated the prognostic role of serum thymidine kinase activity (sTKa), in patients treated with Palbociclib + fulvestrant.

PATIENTS AND METHODS: PYTHIA was a phase II, single-arm, multicentre, trial that enrolled 124 post-menopausal women with endocrine-resistant hormone receptor-positive/HER2-negative metastatic breast cancer. Serum samples were collected pre-treatment (pre-trt; n = 122), at day 15 of cycle 1 (D15; n = 108), during the one week-off palbociclib before initiating cycle 2 (D28; n = 108) and at end of treatment (n = 76). sTKa was determined centrally using Divitum®, a refined ELISA-based assay with a limit of detection of 20 Divitum Units (Du)/L. The primary study endpoint was progression-free survival, assessed for its association with pre- and on-treatment sTKa.

RESULTS: Data from 122 women were analysed. Pre-treatment sTKa was not associated with clinical characteristics and moderately correlated with tissue Ki-67. Palbociclib + fulvestrant markedly suppressed sTKa levels at D15, with 83% of patients recording levels below limit of detection. At D28, sTKa showed a rebound in 60% of patients. At each timepoint, higher sTKa was associated with shorter progression-free survival (each p < 0.001), with the strongest effect at D15.

CONCLUSIONS: STKa is an independent prognostic biomarker in patients treated with palbociclib. High pre-treatment sTKa and its incomplete suppression during treatment may identify patients with poorer prognosis and primary resistance. This warrants validation in prospective comparative trials. CLINICALTRIALS.

GOV IDENTIFIER: NCT02536742; EudraCT 2014-005387-15.

PMID:35172272 | DOI:10.1016/j.ejca.2021.12.030

Infect Dis Now. 2022 Feb 13:S2666-9919(22)00030-6. doi: 10.1016/j.idnow.2022.01.007. Online ahead of print.

ABSTRACT

OBJECTIVES: While the World Health Organization has recommended preoperative washing with plain or antimicrobial soap for surgical site infection (SSI) prevention, it has not formulated recommendations on use of chlorhexidine gluconate (CHG)-impregnated cloths. The purpose of this systematic review was to evaluate the benefit of preoperative bathing with CHG-cloths on SSI incidence.

PATIENTS AND METHODS: Publications were searched on Medline, CENTRAL, Web of Science, Clinical Trial between 01/01/1990 and 30/06/2018. Randomized controlled trials (RCT), quasi-randomized, case-control and cohort studies on patients with surgery (Population) having preoperative bathing with CHG-cloths (Intervention) or antiseptic soap, plain soap, placebo, no washing, no instruction (Comparator) were included. The main outcome was SSI occurrence. The results were synthetized using the Odds-Ratio (OR) and 95% confidence interval [95%CI]. Study quality was assessed using the Cochrane and Newcastle-Ottawa tools and evidence quality with the GRADE method. Statistics were calculated on RevMan5.3.

RESULTS: All in all, 1108 publications were identified and 3 were included in the meta-analysis. OR of the 2 cohort studies was 0.25 [95%CI: 0.13-0.50] for use of CHG-cloths the evening and the morning before intervention versus non-compliance with preoperative washing. OR of the RCT was 0.12 [95%CI: 0.02-1.00] for use of CHG-cloths the evening and the morning before intervention versus a shower with antibacterial soap the evening before the intervention. Study quality was moderate.

CONCLUSIONS: While the available studies show a benefit for CHG-cloths on SSI occurrence in orthopaedic surgery, there is no comparison with usual practices. Further studies are needed to confirm the benefit of CHG-cloths for preoperative washing.

PMID:35172215 | DOI:10.1016/j.idnow.2022.01.007

Int J Drug Policy. 2022 Feb 13;102:103615. doi: 10.1016/j.drugpo.2022.103615. Online ahead of print.

ABSTRACT

BACKGROUND: In 2019-2020, record-high numbers of overdoses have been reported across the UK. We estimated perceived availability to and carriage of naloxone and explored factors associated with carriage among people who inject drugs (PWID) engaged with services in England, Wales, and Northern Ireland.

METHODS: Participants were PWID enrolled in the Unlinked Anonymous Monitoring Survey in 2019 who reported past-year injection drug use (n = 2,139). Recruitment occurred through specialist and community drug agencies located across the UK, excluding Scotland. Socio-demographic, behavioural and service use characteristics were self-reported. Participants were asked whether they carry naloxone (timeframe unspecified). If they answered “no”, they were further asked whether it is available in their area. Perceived naloxone availability and carriage were estimated by requirement region, classified using the Nomenclature of Territorial Units for Statistics 1. We used the Gelberg-Andersen Model of healthcare access to explore predisposing, enabling and need factors associated with regionally-aggregated naloxone carriage.

RESULTS: Perceived naloxone availability was ≥95% in all 11 regions; naloxone carriage varied (mean: 61.1; range: 48%-71%; P<0.01). Among predisposing factors, female gender (adjusted odds ratio (AOR): 1.52; 95% confidence interval (CI): 1.21-1.91) was positively associated with naloxone carriage, whilst recruitment in Yorkshire and the Humber-relative to London-was negatively associated (AOR: 0.55; 95%CI: 0.37-0.82). Among enabling factors, past-year contact with needle and syringe programmes (AOR: 1.74; 95%CI: 1.39-2.18) and currently receiving treatment for drug use (AOR: 1.75; 95%CI: 1.24-2.46) were positively associated with naloxone carriage. Among need characteristics, past-month heroin injection, with or without past-month high-risk drinking or benzodiazepine use, was positively associated with carriage relative to no heroin injection (range of AORs: 1.71-2.58).

CONCLUSION: Perceived naloxone availability is very high among PWID attending services in England, Wales, and Northern Ireland. Naloxone carriage is moderately high and varying across regions, and appears improved through recent engagement with harm-reduction programs.

PMID:35172254 | DOI:10.1016/j.drugpo.2022.103615

J Shoulder Elbow Surg. 2022 Feb 13:S1058-2746(22)00221-X. doi: 10.1016/j.jse.2022.01.125. Online ahead of print.

ABSTRACT

BACKGROUND: The Patient-Reported Outcomes Measurement Information System (PROMIS) has emerged as a valid and efficient means of collecting outcomes in patients with rotator cuff tears. The purpose of this study was to establish threshold score changes to determine minimal clinically important difference (MCID) and substantial clinical benefit (SCB) in PROMIS computer adaptive test (CAT) scores following rotator cuff repair (RCR). Additionally, we sought to identify potential risk factors for failing to achieve MCID and SCB.

METHODS: Patients undergoing arthroscopic RCR were identified over a 24-month period. Only patients that completed both preoperative and postoperative PROMIS CAT assessments were included in this cohort. PROMIS CAT forms for upper extremity physical function (PROMIS-UE), pain interference (PROMIS-PI), and depression (PROMIS-D) were utilized with minimum of 1.5 year follow-up. Statistical analysis was performed to determine threshold score changes to determine anchor-based MCID and SCB, as well as risk factors for failure to achieve significant clinical improvement following surgery.

RESULTS: Of 198 eligible patients, 168 (84.8%) were included in analysis. Delta PROMIS-UE values of 5.8 and 9.7 (area under the curve (AUC) = 0.906 and 0.949, respectively) and delta PROMIS-PI values of -11.4 and -12.9 (AUC = 0.875 and 0.938, respectively) were identified as threshold predictors of MCID and SCB achievement. On average, 81%, 65%, and 55% of patients achieved MCID for PROMIS-UE, PROMIS-PI, and PROMIS-D while 71%, 61%, and 38% of patients in the cohort respectively achieved SCB. MCID achievement in PROMIS-UE significantly differed according to risk factors including smoking status (LR: 9.8, p=0.037), tear size (LR: 10.4, p<0.001), distal clavicle excision (LR: 6.1, p=0.005), and prior shoulder surgery (LR: 19.2, p<0.001). Factors influencing SCB achievement for PROMIS-UE were smoking status (LR: 9.3, p=0.022), tear size (LR: 8.0, p=0.039), and prior shoulder surgery (11.9, p<0.001). Significantly different rates of MCID and SCB achievement in PROMIS-PI for smoking status (LR: 7.0, p=0.030 and LR: 5.2, p=0.045) and prior shoulder surgery (LR: 9.1, p=0.002 and LR: 7.4, p=0.006) were also identified.

DISCUSSION AND CONCLUSION: The majority of patients showed clinically significant improvements that exceeded the established MCID for PROMIS-UE and PROMIS-PI following RCR. Patients with larger tear sizes, a history of prior shoulder surgery, tobacco users, and those who received concomitant distal clavicle excision were at risk for failing to achieve MCID in PROMIS-UE. Additionally, smokers and patients who underwent prior shoulder surgery demonstrated significantly lower improvements in pain scores following surgery.

PMID:35172206 | DOI:10.1016/j.jse.2022.01.125

J Tissue Eng Regen Med. 2022 Feb 16. doi: 10.1002/term.3290. Online ahead of print.

ABSTRACT

Technological advances in the field of implantology have led to the concept of surface modifications to enhance implant stability by utilization of current concepts of tissue engineering and materials such as platelet concentrates and stem cells. The purpose of the present randomized controlled clinical trial was to evaluate and compare the effect of platelet rich fibrin matrix (PRFM) with and without peripheral blood mesenchymal stem cells (PBMSCs) on implant stability; by assessing the bone to implant contact (BIC) using resonance frequency analysis (RFA), insertion torque and also to establish and correlate the same with implant stability quotient (ISQ). A total of 15 patients with 30 sites ensuring a minimum of two dental implants adjacently placed in an edentulous area; with the age group of 25-50 years of both the sexes were categorized into Group 1 (dental implant with PRFM) and Group 2 (dental implant with PBMSCs embedded in PRFM). Insertion torque values at the time of dental implant placement and ISQ using RFA was recorded at 1 week, 1 month, and 3 months post operatively. There was no significant difference (p = 0.81) in Insertion torque values between both the groups (G1 and G2). Platelet rich fibrin matrix along with PBMSCs enhanced implant stability as higher and statistically significant ISQ values were noted at 1 week (p = 0.18), 1 month (p ≤ 0.001), and 3 months (p ≤ 0.001) intervals in the G2 group. Platelet rich fibrin matrix and PBMSCs showed promising results as a potential regenerative material for increasing and enhancing BIC and hence implant stability.

PMID:35172029 | DOI:10.1002/term.3290

Bioinformatics. 2022 Feb 16:btac098. doi: 10.1093/bioinformatics/btac098. Online ahead of print.

ABSTRACT

MOTIVATION: Drawing peaks in a data window of an MS data set happens at all time in MS data visualization applications. This asks to retrieve from an MS data set some selected peaks in a data window whose image in a display window reflects the visual feature of all peaks in the data window. If an algorithm for this purpose is asked to output high quality solutions in real time, then the most fundamental dependence of it is on the storage format of the MS data set.

RESULTS: We present mzMD, a new storage format of MS data sets and an algorithm to query this format of a storage system for a summary (a set of selected representative peaks) of a given data window. We propose a criterion Q-score to examine the quality of data window summaries. Experimental statistics on real MS data sets verified the high speed of mzMD in retrieving high-quality data window summaries. mzMD reported summaries of data windows whose Q-score outperforms those mzTree reported. The query speed of mzMD is the same as that of mzTree whereas its query speed stability is better than that of mzTree.

AVAILABILITY: The source code is freely available at https://github.com/yrm9837/mzMD-java.

SUPPLEMENTARY INFORMATION: Supplementary data are available at Bioinformatics online.

PMID:35171986 | DOI:10.1093/bioinformatics/btac098

Med Phys. 2022 Feb 16. doi: 10.1002/mp.15546. Online ahead of print.

ABSTRACT

PURPOSE: Accurately segmenting curvilinear structures, e.g., retinal blood vessels or nerve fibers, in the medical image is essential to the clinical diagnosis of many diseases. Recently, deep learning has become a popular technology to deal with the image segmentation task and it has obtained remarkable achievement. However, the existing methods still have many problems when segmenting the curvilinear structures in medical images, such as losing the details of curvilinear structures, producing many false-positive segmentation results. To mitigate these problems, we propose a novel end-to-end curvilinear structure segmentation network called Curv-Net.

METHODS: Curv-Net is an effective encoder-decoder architecture constructed based on selective kernel (SK) and multi-bidirectional convolutional LSTM (Multi-Bi-ConvLSTM). To be specific, we first employ the SK module in the convolutional layer to adaptively extract the multi-scale features of the input image, and then we design a Multi-Bi-ConvLSTM as the skip concatenation to fuse the information learned in the same stage and propagate the feature information from the deep stages to the shallow stages, which can enable the feature captured by Curv-Net to contain more detail information and high-level semantic information simultaneously to improve the segmentation performance.

RESULTS: The effectiveness and reliability of our proposed Curv-Net are verified on three public datasets: two color fundus datasets (DRIVE and CHASE_DB1) and one corneal nerve fiber dataset (CCM-2). We calculate the ACC (accuracy), SE (sensitivity), SP (specificity), Dice (Dice similarity coefficient) and AUC (area under the receiver) for the DRIVE and CHASE_DB1 datasets. The ACC, SE, SP, Dice and AUC of the DRIVE dataset are 0.9629, 0.8175, 0.9858, 0.8352 and 0.9810, respectively. For the CHASE_DB1 dataset, the values are 0.9810, 0.8564, 0.9899, 0.8143 and 0.9832, respectively. To validate the corneal nerve fiber segmentation performance of the proposed Curv-Net, we test it on the CCM-2 dataset and calculate Dice, SE and FDR (false discovery rate) metrics. The Dice, SE and FDR achieved by Curv-Net are 0.8114±0.0062, 0.8903±0.0113 and 0.2547±0.0104, respectively.

CONCLUSIONS: Curv-Net is evaluated on three public datasets. Extensive experimental results demonstrate that Curv-Net outperforms the other superior curvilinear structure segmentation methods. This article is protected by copyright. All rights reserved.

PMID:35172016 | DOI:10.1002/mp.15546

PLoS One. 2022 Feb 16;17(2):e0264021. doi: 10.1371/journal.pone.0264021. eCollection 2022.

ABSTRACT

BACKGROUND: Acanthamoeba keratitis is challenging to treat and thought to result in poor outcomes, but very few comparative studies exist to assess whether ulcers caused by Acanthamoeba are worse than those caused by bacteria or fungus.

METHODS: In a retrospective cohort study, all cases of smear- or culture-proven Acanthamoeba keratitis diagnosed from January 2006 to June 2011 at an eye hospital in South India were identified from the microbiology database. Random samples of the same number of cases of bacterial and fungal keratitis, matched by year, were identified from the same database in order to compare outcomes between the three types of organism. The main outcomes were the time until the following events: re-epithelialization, discontinuation of antimicrobials, perforation/keratoplasty, elevated intraocular pressure, and new cataract.

RESULTS: The median time until re-epithelialization was 113 days for Acanthamoeba keratitis, 30 days for fungal keratitis, and 25 days for bacterial keratitis, and the median time until discontinuation of antimicrobial therapy was 100 days for Acanthamoeba keratitis, 49 days for fungal keratitis, and 40 days for bacterial keratitis. Compared to the other two organisms, Acanthamoeba ulcers took significantly longer to re-epithelialize (adjusted HR 0.4, 95% CI 0.3 to 0.6 relative to bacterial ulcers and HR 0.3, 95% CI 0.2 to 0.5 relative to fungal ulcers; overall p<0.001) and had significantly longer courses of antimicrobials (adjusted HR 0.3, 95% CI 0.2 to 0.6 relative to bacterial ulcers and HR 0.5, 95%CI 0.3 to 0.8 relative to fungal ulcers; overall p<0.001). No statistically significant difference was observed between the three organisms for the other time-to-event outcomes.

CONCLUSIONS: Acanthamoeba keratitis was more difficult to treat and had worse clinical outcomes than bacterial or fungal ulcers, highlighting the lack of adequate treatment regimens for this infection.

PMID:35171970 | DOI:10.1371/journal.pone.0264021

PLoS One. 2022 Feb 16;17(2):e0263890. doi: 10.1371/journal.pone.0263890. eCollection 2022.

ABSTRACT

BACKGROUND: Bangladesh is a South Asian developing country trying to achieve the Sustainable Development Goals (SDG)-3 and the objective of the Rural Electrification Board (REB) regarding child mortality. Infectious diseases are leading causes of child mortality, and lack of exclusive breastfeeding (EBF) among infants aged 0-6 months increases child morbidity and mortality from various infectious diseases in developing countries. However, as per existing literature, no study has been conducted yet to determine the lack of EBF practice effect on child mortality in Bangladesh. With this backdrop, the authors intend to measure the likelihood of infectious diseases due to the lack of EBF of infants aged 0-6 months in Bangladesh.

MATERIALS AND METHODS: This study used Bangladesh Demographic and Health Survey (BDHS) data over 1996-97 to 2017-18. The mothers of infants aged 0-6 months who were willingly participated in the BDHSs were considered to include in our analysis. Initially, there were 9,133 cases in the combined dataset. After filtering, there were 5,724 cases in the final dataset. We have considered diarrhea (D), acute respiratory infection (ARI) separately as well as the presence of either D or ARI or both and named as CoDARI as outcome variables. This study used both graphical and statistical techniques (Chi-square test, Wald test, and logistic regression) to analyze the data. The odds ratio (OR) and 95% confidence interval (CI) were used to quantify the likelihood of infectious diseases due to lack of EBF practice and its elasticity, respectively.

RESULTS: The EBF practice got a conspicuous increasing trend, but the prevalence of infectious diseases was declined from 0 to 3 months of age of infants, whereas an inverse scenario is observed between 4-6 months. The significance of that inverse relationship was confirmed by p-value corresponding to the chi-square test and the Wald test of the adjusted regression coefficients after adjusting the associated factor’s effect on infectious diseases. The adjusted ORs also concluded that the lack of EBF practice up to six months of age could enhance the risk of D, ARI, and CoDARI by 2.11 [95% CI: 1.56-2.85], 1.43 [95% CI: 1.28-1.60], and 1.48 [95% CI: 1.32-1.66] times higher, respectively.

CONCLUSION: Findings of this study emphasize the importance of EBF up to six months of age of infants against diarrhea and ARI specific morbidity and mortality. Our results also agreed to the recommendation of the World Health Organization (WHO), United Nations International Children’s Emergency Fund (UNICEF), American Academy of Pediatrics (AAP), American Academy of Family Physicians (AAFP), and National Nutrition Programme of Ethiopia (NNPE) that the EBF practice for the first six months of age could be a best, cost-effective, long-lasting natural preventive way to reduce the child morbidity and mortality due to infectious diseases in developing countries. Therefore, findings would help policymakers ensuring the achievement target of REB and SDG-3 associated with the health sector in Bangladesh.

PMID:35171952 | DOI:10.1371/journal.pone.0263890