Tag: statistics

J Natl Cancer Inst. 2021 Sep 11:djab172. doi: 10.1093/jnci/djab172. Online ahead of print.

ABSTRACT

BACKGROUND: The symptom burden associated with cancer and its treatment can negatively impact patients’ quality of life and survival. Symptom-focused collaborative care model (CCM) interventions can improve outcomes, but only if patients engage with them. We assessed the receptivity of severely symptomatic oncology patients to a remote nurse-led CCM intervention.

METHODS: In a pragmatic, cluster-randomized, stepped wedge trial conducted as part of the NCI IMPACT Consortium (E2C2, NCT03892967), patients receiving cancer care were asked to rate their sleep disturbance, pain, anxiety, emotional distress, fatigue, and limitations in physical function. Patients reporting at least one severe symptom (≥7/10) were offered phone consultation with a nurse symptom care manager (RN SCM). Initially, patients had to “opt-in” to receive a call, but the protocol was later modified so they had to “opt-out” if they did not want a call. We assessed the impact of opt-in vs. opt-out framing and patient characteristics on receptiveness to RN SCM calls. All statistical tests were 2-sided.

RESULTS: Of the 1204 symptom assessments (from 864 patients) on which at least one severe symptom was documented, 469 (39.0%) indicated receptivity to an RN SCM phone call. The opt-out period (odds ratio [OR] = 1.61, 95% confidence interval [CI] = 1.12 to 2.32, p=.01), receiving care at a tertiary care center (OR = 3.59, 95% CI = 2.18 to 5.91, p<.001), and having severe pain (OR = 1.80, 95% CI = 1.24 to 2.62, p=.002), were associated with statistically significantly greater willingness to receive a call.

CONCLUSION: Many severely symptomatic patients were not receptive to an RN SCM phone call. Better understanding of reasons for refusal and strategies for improving patient receptivity are needed.

PMID:34508602 | DOI:10.1093/jnci/djab172

J Clin Endocrinol Metab. 2021 Sep 11:dgab671. doi: 10.1210/clinem/dgab671. Online ahead of print.

ABSTRACT

CONTEXT: Obesity prevalence has increased in type 1 diabetes (T1D). However, the relationship between body composition and severe diabetic eye disease (SDED) is unknown.

OBJECTIVE: To investigate the associations between body composition and SDED in adults with T1D.

METHODS: From 5401 adults with T1D in the Finnish Diabetic Nephropathy Study, we assessed 3468, and 437 underwent dual-energy-X-ray-absorptiometry for body composition analysis. The composite outcome was SDED, defined as proliferative retinopathy, laser treatment, anti-VEGF treatment, diabetic maculopathy, vitreous hemorrhage, and vitrectomy. Logistic regression analysis evaluated the associations between body composition and SDED. Multivariable Cox regression analysis assessed the associations between the anthropometric measures and SDED. Subgroup analysis was performed by stages of albuminuria. The relevance ranking of each variable was based on the z statistic.

RESULTS: During a median follow-up of 14.5 (IQR 7.8-17.5) years, 886 SDED events occurred. Visceral/android fat ratio was associated with SDED (OR 1.40, z=3.13), as well as the percentages of visceral (OR 1.80, z=2.45) and android fat (OR 1.28, z=2.08), but not the total body fat percentage. Waist-height ratio showed the strongest association with the SDED risk (HR=1.28, z= 3.73), followed by the waist (HR 1.01, z=3.03), body mass index (HR 1.03, z=2.33), and waist-hip ratio (HR 1.15, z=2.22). The results were similar in normo- and microalbuminuria, but not significant in macroalbuminuria. A WHtR ≥ 0.5 increased the SDED risk by 28% at the normo- and microalbuminuria stages.

CONCLUSIONS: WHtR, a hallmark of central obesity, is associated with SDED in individuals with type 1 diabetes.

PMID:34508598 | DOI:10.1210/clinem/dgab671

Int J Epidemiol. 2021 Sep 11:dyab180. doi: 10.1093/ije/dyab180. Online ahead of print.

ABSTRACT

BACKGROUND: Research documents social and economic antecedents of adverse birth outcomes, which may include involuntary job loss. Previous work on job loss and adverse birth outcomes, however, lacks high-quality individual data on, and variation in, plausibly exogenous job loss during pregnancy and therefore cannot rule out strong confounding.

METHODS: We analysed unique linked registries in Denmark, from 1980 to 2017, to examine whether a father’s involuntary job loss during his spouse’s pregnancy increases the risk of a low-weight (i.e. <2500 grams) and/or preterm (i.e. <37 weeks of gestational age) birth. We applied a matched-sibling design to 743 574 sibling pairs.

RESULTS: Results indicate an increased risk of a low-weight birth among infants exposed in utero to fathers’ unexpected job loss [odds ratio (OR) = 1.37, 95% confidence interval (CI): 1.07, 1.75]. Sex-specific analyses show that this result holds for males (OR = 1.70, 95% CI: 1.14, 2.53) but not females (OR = 1.24, 95% CI: 0.80, 1.91). We find no relation with preterm birth.

CONCLUSIONS: Findings support the inference that a father’s unexpected job loss adversely affects the course of pregnancy, especially among males exposed in utero.

PMID:34508593 | DOI:10.1093/ije/dyab180

Hum Mol Genet. 2021 Sep 11:ddab261. doi: 10.1093/hmg/ddab261. Online ahead of print.

ABSTRACT

The use of external controls in genome-wide association study (GWAS) can significantly increase the size and diversity of the control sample, enabling high-resolution ancestry matching and enhancing the power to detect association signals. However, the aggregation of controls from multiple sources is challenging due to batch effects, difficulty in identifying genotyping errors, and the use of different genotyping platforms. These obstacles have impeded the use of external controls in GWAS and can lead to spurious results if not carefully addressed. We propose a unified data harmonization pipeline that includes an iterative approach to quality control (QC) and imputation, implemented before and after merging cohorts and arrays. We apply this harmonization pipeline to aggregate 27 517 European control samples from 16 collections within dbGaP. We leverage these harmonized controls to conduct a GWAS of Crohn’s disease. We demonstrate a boost in power over using the cohort samples alone, and that our procedure results in summary statistics free of any significant batch effects. This harmonization pipeline for aggregating genotype data from multiple sources can also serve other applications where individual level genotypes, rather than summary statistics, are required.

PMID:34508597 | DOI:10.1093/hmg/ddab261

Rheumatology (Oxford). 2021 Sep 11:keab699. doi: 10.1093/rheumatology/keab699. Online ahead of print.

ABSTRACT

OBJECTIVE: SM03, a novel chimeric monoclonal antibody specific to B cell-restricted antigen CD22, has been developed to treat rheumatoid arthritis (RA) and other B cell-related diseases. This 24-week Phase II randomized, double-blind, multi-dose, placebo-controlled study aimed to evaluate the efficacy and safety of SM03 in moderately-to-severely active RA patients in China.

METHODS: One hundred fifty-six patients on background methotrexate were randomized in a 1:1:1 ratio to receive a cumulative dose of 3600 mg (high dose, 600 mg * 6 infusions at weeks 0, 2, 4, 12, 14, and 16) or 2400 mg SM03 (low dose, 600 mg * 4 infusions at weeks 0, 2, 12, and 14), or the placebo. The primary outcome was the 24-week American College of Rheumatology 20% improvement criteria (ACR20) response rate. Safety was also assessed.

RESULTS: The 24-week ACR20 response rate was significantly higher with high (65.3%, p= 0.002) and low-dose SM03 (56.9%, p= 0.024) than placebo (34.0%), but comparable between the high and low dose group. The rate of adverse events was not statistically different among the high dose group (35.3%), the low dose group (51.9%) and the placebo group (34.6%). Thirteen (12.6%) patients receiving SM03 reported treatment-emergent infections, including 3.9% patients in the high-dose group. No patients reported severe treatment-emergent infections or malignancies.

CONCLUSIONS: In active RA Chinese patients receiving background methotrexate, SM03 at a cumulative dose of both 2400 mg and 3600 mg is efficacious and well-tolerated throughout the 24 weeks of treatment. Moreover, SM03 has demonstrated a good safety profile.

TRIAL REGISTRATION NUMBER: ClinicalTrials.gov, https://clinicaltrials.gov, NCT04192617.

PMID:34508557 | DOI:10.1093/rheumatology/keab699

Rheumatology (Oxford). 2021 Sep 11:keab629. doi: 10.1093/rheumatology/keab629. Online ahead of print.

ABSTRACT

OBJECTIVES: To explore the efficacy of plasma exchange (PE) therapy in refractory idiopathic inflammatory myopathy (IIM) patients with positive anti-signal recognition particle (SRP) antibody.

METHODS: Nine refractory IIM patients with positive anti-SRP antibody were enrolled, who received PE therapy at Ruijin Hospital from Octobor 2017 to December 2020. The clinical manifestations, laboratory tests, chest CT and lower extremity MRI images before and after PE therapy were compared. The treatment response was evaluated by the 2016 American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) myositis response criteria.

RESULTS: 88.9% (8/9) subjects had achieved improvement by 3 weeks after PE therapy, with 55.6% (5/9) minimal improvement and 33.3% (3/9) moderate improvement. There were statistically significant improvements between baseline and after PE therapy at 3 weeks on the core set measures: physician global activity, patient global activity, Health Assessment Questionnaire (HAQ), manual muscle testing (MMT), extramuscular disease activity, and muscle enzymes activity including creatine kinase (CK), lactate dehydrogenase (LDH), aspartate transaminase (AST), except for alanine transaminase (ALT). Moreover, the chest CT showed regression of ground glass opacities and irregular linear opacities after PE therapy in four patients with interstitial lung disease. The MRI images of lower extremity in four patients showed reduction of muscle oedema after the therapy.

CONCLUSION: PE therapy is effective for refractory IIM patients with positive anti-SRP antibody. It should be considered as an alternative treatment for those patients who are resistant to the combined therapy of glucocorticoids and immunosuppressive agents.

PMID:34508561 | DOI:10.1093/rheumatology/keab629

JNMA J Nepal Med Assoc. 2021 Apr 30;59(236):322-326. doi: 10.31729/jnma.5150.

ABSTRACT

INTRODUCTION: Cesarean section is a common obstetric procedure which is done to reduce complications in high risk pregnancies. The aim of study was to find out the prevalence of cesarean section in a maternity unit of a tertiary care center.

METHODS: A descriptive cross-sectional study was conducted among 497 pregnant women presenting in a maternity unit of a tertiary center of Kathmandu, Nepal over a period of six months from March to August 2017 after taking ethical approval from Institutional Review Committee (Ref. 24). In this study, the prevalence of cesarean section, perinatal outcome, maternal and neonatal complications if any were observed. Data and descriptive analysis were done using Statistical Package for the Social Sciences version 22. Point estimate at 95% Confidence Interval was calculated along with frequency and percentage for binary data.

RESULTS: The prevalence of cesarean section was 171 (34.4%) at 95% Confidence interval (30.2-38.7). Most common indication for cesarean section was fetal distress 53 (31%). The maternal complications developed in 11 (6.4%) among those who delivered via cesarean delivery; Surgical Site Infection being the most common maternal complication. The neonatal intensive care unit admission rate among the newborns via cesarean section delivery was 48 (27.43%) and neonatal sepsis 14 (8%) was most common adverse neonatal outcome.

CONCLUSIONS: The cesarean rate at the study center is higher than standard target rate of World Health Organization. Neonatal and maternal adverse outcome in current study were comparable with existing literatures.

PMID:34508541 | DOI:10.31729/jnma.5150

Br J Surg. 2021 Sep 11:znab260. doi: 10.1093/bjs/znab260. Online ahead of print.

ABSTRACT

BACKGROUND: A permanent stoma after anterior resection for rectal cancer is common. Preoperative counselling could be improved by providing individualized accurate prediction modelling.

METHODS: Patients who underwent anterior resection between 2007 and 2015 were identified from the Swedish Colorectal Cancer Registry. National Patient Registry data were added to determine presence of a stoma 2 years after surgery. A training set based on the years 2007-2013 was employed in an ensemble of prediction models. Judged by the area under the receiving operating characteristic curve (AUROC), data from the years 2014-2015 were used to evaluate the predictive ability of all models. The best performing model was subsequently implemented in typical clinical scenarios and in an online calculator to predict the permanent stoma risk.

RESULTS: Patients in the training set (n = 3512) and the test set (n = 1136) had similar permanent stoma rates (13.6 and 15.2 per cent). The logistic regression model with a forward/backward procedure was the most parsimonious among several similarly performing models (AUROC 0.67, 95 per cent c.i. 0.63 to 0.72). Key predictors included co-morbidity, local tumour category, presence of metastasis, neoadjuvant therapy, defunctioning stoma use, tumour height, and hospital volume; the interaction between age and metastasis was also predictive.

CONCLUSION: Using routinely available preoperative data, the stoma outcome at 2 years after anterior resection for rectal cancer can be predicted fairly accurately.

PMID:34508549 | DOI:10.1093/bjs/znab260

JNMA J Nepal Med Assoc. 2021 Apr 30;59(236):361-364. doi: 10.31729/jnma.5500.

ABSTRACT

INTRODUCTION: Healthcare workers are always at the risk of exposure to different diseases like respiratory illness including COVID-19. Using appropriate face mask or respiratory protective equipment correctly can prevent transmission of diseases from and to healthcare workers while caring for patients. The study aimed to find out the practice regarding use of face masks during the COVID-19 pandemic in a tertiary care center.

METHODS: A descriptive cross-sectional study was conducted at a tertiary care hospital during June-July 2020 after receiving ethical approval from the review committee regarding practice of use of face masks. Convenience sampling method was used and a sample size of 162 was taken. Descriptive statistical analysis was done. Point estimate at 95% Confidence Interval was calculated along with frequency and proportion for binary data.

RESULTS: Among 162 participants, 123 (75.9%) knew the correct way of using the masks (72.5-79.3 at 95% Confidence Interval).

CONCLUSIONS: In this study regarding practice of use of face masks, most of the healthcare workers knew the correct way of using masks and practised hygiene before and after using masks.

PMID:34508538 | DOI:10.31729/jnma.5500

JNMA J Nepal Med Assoc. 2021 Apr 30;59(236):350-355. doi: 10.31729/jnma.5360.

ABSTRACT

INTRODUCTION: Gonial angle measurements serve as an important parameter of the craniofacial complex and are usually studied on lateral cephalograms, but recently panoramic radiographs have also been used. The aim of this study is to measure the gonial angle using orthopantomogram and lateral cephalogram based on age, gender, ethnicity, and skeletal malocclusion in a tertiary care hospital.

METHODS: This is a descriptive cross-sectional study comprising 350 selected radiographs of apparently healthy individuals collected for a period of one year, from the Department of Oral Radiology of a tertiary care centre of Nepal. Gonial angle measurements were recorded from digital panoramic radiograph (both right and left side) and lateral cephalogram. Data was collected in terms of age, gender, ethnicity, and skeletal malocclusion and then statistically analysed using the Statistical Package for the Social Sciences version 20.

RESULTS: The mean gonial angle for panoramic right, left and lateral cephalogram was 122.490±7.570, 123.620±7.060, and 124.150±6.910, respectively. There was a decrease in the mean values of the gonial angle observed as age advances seen in all the radiographs. The gonial angle measured in Class III malocclusion was higher in all the radiographs, followed by Class II and Class I. Gonial angles obtained in females were higher than the males in all the radiographs. Finally, the Aryan population showed a higher gonial angle compared to the Mongolian population in all the radiographs.

CONCLUSIONS: Panoramic radiograph (left side), could be considered as a reliable tool to measure the gonial angle.

PMID:34508539 | DOI:10.31729/jnma.5360