Category: Statistics

J Pediatr Gastroenterol Nutr. 2022 Jun 6. doi: 10.1097/MPG.0000000000003510. Online ahead of print.

ABSTRACT

OBJECTIVES: To determine how the use of biological therapy is associated with surgical intervention for paediatric inflammatory bowel disease (PIBD) at population level.

METHODS: Hospital Episode Statistics data were obtained for all admissions within England, (1997-2015), in children aged 0-18 years, with an ICD-10 code for diagnosis of Crohn’s disease (CD), ulcerative colitis (UC) or inflammatory bowel disease-unclassified (IBD-U). OPCS codes for major surgical resection associated with PIBD and for biological therapy were also obtained. Data are presented as median values (interquartile range).

RESULTS: In total, 22,645 children had a diagnosis of PIBD of which 13,722 (61%) had CD, 7,604 (34%) UC and 1,319 (5.8%) cases IBD-U. Biological therapy was used in 4,054 (17.9%) cases. Surgical resection was undertaken in 3,212 (14%) cases, more commonly for CD than UC (17.5 vs 10.3%, p<0.0001). Time from diagnosis to major surgical resection was 8.3 (1.2-28.2) months in CD and 8.2 (0.8-21.3) months in UC. As the time-frame of the data-set progressed, there was a decreased rate of surgical intervention (p=0.04) and an increased use of biological therapy (p<0.0001). Additionally, the number of new diagnoses of PIBD increased.

CONCLUSION: The introduction of biologic agents has been associated with a reduction in cases undergoing surgery in children with a known diagnosis of PIBD. As time progresses we will be able to determine whether biological therapies prevent the need for surgery altogether or just delay this until adulthood.An infographic is available for this article at: http://links.lww.com/MPG/C846.

PMID:35666884 | DOI:10.1097/MPG.0000000000003510

J Pediatr Gastroenterol Nutr. 2022 Jun 6. doi: 10.1097/MPG.0000000000003493. Online ahead of print.

ABSTRACT

OBJECTIVES: We aimed to determine the growth and safety parameters in newborns fed a goat milk based infant formula (GMF) using a randomized double-blind trial, in which a cow milk formula (CMF) served as a control and a breast fed (BF) group as a reference.

METHODS: Healthy term infants (n=218) aged up to 14 days old were recruited from 25 European study centers and randomized to GMF or CMF. Weight, length, head circumference were measured at baseline, and at 14, 28, 56, 84, and 112 days at the study clinics. Adverse events were recorded and stool characteristics, reflux, fussiness, colic, and flatulence were self-reported by parents in 3-day diaries. Anthropometric measurements were transformed to WHO standardized age- and sex adjusted z-scores. Analyses of covariance and linear mixed modeling were used to statistically analyze growth, while adjusting for potential confounders when studying the breast-fed group (n=86).

RESULTS: Comparing the GMF to the CMF group, weight gain [mean difference 227.8 g (95% CI -16.6-439.0)] and z-scores for anthropometric measurements were similar after 112 days intervention. Infant formula groups showed greater mean (SD) weight z-scores than the BF group from 84 days onwards (GMF: 0.28 (0.84), CMF: 0.12 (0.88), BF -0.19 (1.02), p<0.05), whereas length and head circumference z-scores were similar. Incidences of serious adverse events and reflux, fussiness, colic, and flatulence were similar among the three groups.

CONCLUSION: Our data demonstrate that GMF provides adequate growth, has a good tolerability, and is safe to use in infants.

PMID:35666856 | DOI:10.1097/MPG.0000000000003493

Circ Genom Precis Med. 2022 Jun 6:101161CIRCGEN121003612. doi: 10.1161/CIRCGEN.121.003612. Online ahead of print.

ABSTRACT

BACKGROUND: Although many polygenic risk scores (PRS) for cardiovascular traits have been developed in European populations, it is an urgent task to construct a PRS and to evaluate its ability in non-European populations. We developed a genome-wide PRS for blood pressure in a Japanese population and examined the associations between this PRS and hypertension prevalence.

METHODS: We performed a cross-sectional study in 11 252 Japanese individuals who participated in the J-MICC (Japan Multi-Institutional Collaborative Cohort) study. Using publicly available GWAS summary statistics from Biobank Japan, we developed the PRS in the target data (n=7876). With >30 000 single nucleotide polymorphisms, we evaluated PRS performance in the test data (n=3376). Hypertension was defined as systolic blood pressure of 130 mm Hg or more, or diastolic blood pressure of 85 mm Hg or more, or taking an antihypertensive drug.

RESULTS: Compared with the middle PRS quintile, the prevalence of hypertension at the top PRS quintile was higher independently from traditional risk factors (odds ratio, 1.73 [95% CI, 1.32-2.27]). The difference of mean systolic blood pressure and diastolic blood pressure between the middle and the top PRS quintile was 4.55 (95% CI, 2.26-6.85) and 2.32 (95% CI, 0.86-3.78) mm Hg, respectively. Subgroups reflecting combinations of Japanese PRS and modifiable lifestyles and factors (smoking, alcohol intake, sedentary time, and obesity) were associated with the prevalence of hypertension. A European-derived PRS was not associated with hypertension in our participants.

CONCLUSIONS: A PRS for blood pressure was significantly associated with hypertension and BP traits in a general Japanese population. Our findings also highlighted the importance of a combination of PRS and risk factors for identifying high-risk subgroups.

PMID:35666837 | DOI:10.1161/CIRCGEN.121.003612

Int J Med Robot. 2022 Jun 6:e2431. doi: 10.1002/rcs.2431. Online ahead of print.

ABSTRACT

INTRODUCTION: The purpose of this study was to evaluate outcomes in elderly patients (age≥65 years) undergoing robotic colorectal surgery (RCRS) in comparison with non-elderly patients.

MATERIALS AND METHODS: Data was collected on elderly and non-elderly patients who underwent RCRS from a prospectively maintained database.

RESULTS: A total of 89 elderly and 73 non-elderly patients were identified. No statistically significant differences in postoperative complication, reoperation, wound infection, anastomotic leak or mortality were observed. The median length of stay was 1 day longer in elderly patients (p=0.007). Subgroup analysis of octogenarians demonstrated outcomes that compared favourably with younger patients.

CONCLUSION: RCRS in elderly patients is safe and effective, with outcomes that do not differ significantly with younger patients. Older age should not be considered to be a specific exclusion criteria for RCRS. To our knowledge, this study represents the largest in the literature to examine outcomes specifically in elderly patients undergoing RCRS. This article is protected by copyright. All rights reserved.

PMID:35666815 | DOI:10.1002/rcs.2431

IEEE Trans Cybern. 2022 Jun 6;PP. doi: 10.1109/TCYB.2022.3172790. Online ahead of print.

ABSTRACT

Due to the frequent changes in operating conditions, time-varying behaviors, including slow-varying dynamics and switching modes, commonly exist in industrial processes, resulting in different degrees of shifting in the process data distribution. When the data distribution shifts in a relatively wide range, conventional adaptive methods become ineffective since they are unable to distinguish normal shifts from real faults, leading to false alarms. In this study, an incremental variational Bayesian Gaussian mixture model (IncVBGMM) is proposed for developing a fine-scale adaptive monitoring scheme to efficiently accommodate the shifting data distribution caused by different degrees of time-varying behaviors. First, IncVBGMM with decremental optimization is proposed to adapt to the changing data distribution via the automatic complement of local models while reducing redundancy to optimize the mixture model. Then, a fine-scale adaptive monitoring scheme is built with physical interpretations to discern between normal shifts and real faults by joint analysis of the static and dynamic information. In addition, a novel monitoring statistic called the expectation of variational Bayesian inference distance (EVBID) is proposed, which can quantify the distance from samples to the variational monitoring model and indicate the fault effects. Case studies involving a real-world three-phase flow facility reveal that the proposed method can accurately differentiate various types of faults from normal shifts and effectively adapt to the time-varying dynamics.

PMID:35666782 | DOI:10.1109/TCYB.2022.3172790

IEEE/ACM Trans Comput Biol Bioinform. 2022 Jun 6;PP. doi: 10.1109/TCBB.2022.3178446. Online ahead of print.

ABSTRACT

Statistical analysis on genomic data can explore the relationship between gene sequence and phenotype. Particularly, counting the genomic mutation samples and associating with related phenotypes for statistical analysis can annotate the variation sites and help to diagnose genovariation. Expansion of the size of variation sample data helps to increase the accuracy of statistical analysis. It is feasible to securely share data from genomic databases on cloud platforms. In this paper, we design a secure counting query protocol that can securely share genomic data on cloud platforms. Our protocol supports statistical analysis of the genomic data in VCF (Variant Call Format) files by counting query. There are three participants of data owner, cloud platform and query party. Firstly, the genomic data is preprocessed to reduce the data size. Secondly, Paillier homomorphic is used so that genomic data can be securely shared and calculated on cloud platform. Finally, the results which be decrypted is used to implement counting function of the protocol. Experimental results show that the protocol can implement the query counting function after homomorphic encryption. The query time is less than 1 second, which provide a feasible solution to share genomic data securely on cloud platform for statistical analysis.

PMID:35666798 | DOI:10.1109/TCBB.2022.3178446

PLoS One. 2022 Jun 6;17(6):e0269690. doi: 10.1371/journal.pone.0269690. eCollection 2022.

ABSTRACT

The integration of family planning (FP) with childhood immunisations is considered a promising approach to addressing postpartum women’s unmet need for FP in resource limited settings. This study set out to examine client and health provider perceptions of the quality of FP services that were integrated with childhood immunisations in Kenya and Uganda. Semi-structured interviews with clients (n = 30) and health providers (n = 27) were conducted in 16 rural health facilities. Interviews centred on the respondents’ experiences receiving/delivering FP services, their interactions with providers/clients, and their views on the quality of FP services. Client and provider perceptions of quality were compared through a thematic analysis of interview transcripts, and findings were synthesised using Jain and Hardee’s revised FP Quality of Care Framework. Using audit data, health facility characteristics and resources were also summarised through descriptive statistics to contextualise the qualitative findings. The dignity and respect experienced by clients was central to the respondents’ perceptions of quality. These two dimensions were not conceptualised as distinct facets of quality, but were instead perceived to be a product of the 1) access to needed services, 2) choice of contraceptives, 3) interpersonal communication, 4) information, and 5) confidentiality afforded to clients. Additionally, clients and providers alike believed that the integration of FP services with childhood immunisations had a positive effect on clients’ access to needed services and on the confidentiality they experienced in a context where modern contraceptive use was stigmatised and where a lack of support from some husbands impeded access to FP services. Understanding clients’ and providers’ conceptualisation of quality is critical to the design of high quality and client-centred integrated FP services.

PMID:35666759 | DOI:10.1371/journal.pone.0269690

Lung Cancer. 2022 May 27;169:61-66. doi: 10.1016/j.lungcan.2022.05.016. Online ahead of print.

ABSTRACT

OBJECTIVES: Recent advances in lung cancer treatment warrants reassessment of the volume-outcome association in lung cancer surgery. This study reassessed the relationship between surgical case-volume and both in-hospital and long-term mortality after lung cancer surgery using a current database to reflect recent advances.

MATERIALS AND METHODS: Using the database of the National Health Insurance Service in Korea, data of all adult patients who underwent lung cancer surgery in Korea between 2005 and 2019 were obtained. Hospitals were categorized by the annual number of lung cancer surgeries. Risk-adjusted in-hospital and 1, 3, 5-year mortality after surgery were assessed.

RESULTS: A total of 84,194 lung cancer surgeries were performed in 163 centers during the study period. High-volume centers were defined as > 200 cases/year, medium-volume centers as 60-200 cases/year, and low-volume centers as < 60 cases/year. After adjustment, in-hospital mortality was significantly lower in high-volume centers (1.03%) compared to medium-volume centers (2.06%, adjusted odds ratio [OR], 1.43; 95% confidence interval [CI], 1.23-1.65; P < 0.001), and low-volume centers (3.08%, OR, 1.32; 95% CI, 1.16-1.51; P < 0.001). Long-term mortality was also significantly lower in high-volume centers compared to the other groups.

CONCLUSION: High-volume centers showed lower in-hospital and long-term mortality compared to centers with less case-volume.

PMID:35660970 | DOI:10.1016/j.lungcan.2022.05.016

J Cancer Res Clin Oncol. 2022 Jun 4. doi: 10.1007/s00432-022-04079-x. Online ahead of print.

ABSTRACT

PURPOSE: Lung cancer is the leading cause of cancer mortality worldwide. To improve the therapeutic outcomes, drug delivery systems, and particularly liposomes, have been widely investigated. Therefore, this review analyzed systematically the literature to inquire about the safety and efficacy of liposomal formulations in lung cancer treatment.

METHODS: Three electronic databases (PubMed, Web of Science and Cochrane CENTRAL) were systematically searched until May 2020. Clinical trials containing information about the effects of liposomal formulations in lung cancer patients were considered eligible.

RESULTS: Twenty two selected studies present different treatment options for both small and non-small-cell lung cancers. After compiling and analyzing all the published information, we verified that combination of liposomal cisplatin and paclitaxel led to a statistically significant improvement of the evaluated outcomes. Moreover, tecemotide, a liposome-based immunotherapy, demonstrated lower toxicity compared to control groups. Evidences that other subgroups could benefit from this formulation were also provided.

CONCLUSION: This systematic review (registration number CRD42021246587) demonstrates that liposomal formulations are promising alternatives to overcome limitations of traditional cancer therapy. However, larger, longer, randomized and double-blinded clinical trials, selecting their patients’ cohort considering more responsive subgroups would be beneficial to strengthen the scientific and clinical evidence of the results herein reported.

PMID:35660950 | DOI:10.1007/s00432-022-04079-x

Mod Rheumatol. 2022 Jun 4:roac057. doi: 10.1093/mr/roac057. Online ahead of print.

ABSTRACT

OBJECTIVES: To evaluate the efficacy and safety of intravenous immunoglobulin (IVIG) in the treatment of dermatomyositis (DM) and polymyositis (PM).

METHODS: A comprehensive systematic review was conducted in accordance with the guidelines of PRISMA (Preferred Reporting Items for Systematic Reviews And Meta-analyses). PubMed, Embase, and China National Knowledge Infrastructure (CNKI) were searched to find articles published between July 1919 and May 2021 concerning IVIG therapy in PM/DM. We analyzed continuum data through mean difference and the estimated pooled improvement rate through Log transformation. We calculated all the effect measures with a 95% confidence interval. The I²statistic was calculated to assess statistical heterogeneity across the studies. I²values of 25%, 50% and 75% were defined as low, moderate and high, respectively. All analyses were conducted using R Studio, Version 3.6.3.

RESULTS: Seventeen papers pertinent to our questions were found: three case-control studies, fourteen non-randomized studies. We evaluated the efficacy of IVIG in DM/PM by the indicators of creatine kinase (CK), Manual Muscle Test (MMT) scores, Medical Research Council (MRC) scale, the Activities of Daily Living (ADL) scale and the pooled improvement rate. In a meta-analysis, we found that IVIG significantly improved the level of CK (SMD -0.69, 95%CI -0.93, -0.46; P<0.0001), MMT (SMD 1.12; 95%CI 0.77, 1.47; P<0.00001), MRC (SMD 1.59; 95%CI 0.86, 2.33; P<0.00001), ADL (SMD 1.07; 95%CI 0.59, 1.56; P<0.0001). The CK levels in DM and PM were also significantly improved after IVIG (SMD = -0.73, 95%CI -1.12, -0.34; P=0.0002; and SMD = -3.29, 95%CI -5.82, -0.76; P < 0.0001, respectively). The meta-analysis of three RCTs showed that there was a statistically significant improvement after IVIG (SMD 0.63; 95%CI 0.22, 1.03; P=0.002). In a random effects model pooled muscle power improvement rate was 77% (95% CI: 66.0-87.0%). Meta-analyses of IVIG as first-line therapy showed a significant improvement of CK level (SMD -0.71; 95%CI -1.12, -0.30; P=0.0007). In three studies, the polled improvement rate of esophageal disorders was 88% (95% CI: 80.0-95.0%). There was no statistically significant difference in the rate of improvement between the number of courses < 2 and ≥ 2 (0.80 vs. 0.80 %, P = 0.9). The corticosteroid-sparing effect of IVIG was also well demonstrated, with the proportion of corticosteroid-sparing success reaching 81.8% (72/88). Adverse reactions included headache, fever, Hypotension and dizzy and so on. Mild cortical stroke, staphylococcal septicaemia, asymptomatic myocardial infarction, cerebral infarction, deep vein thrombosis and subendocardial ischemia as severe adverse events were found in seven cases.

CONCLUSION: IVIG seems to be an effective drug for DMPM, improving muscle strength, CK levels and esophageal involvement, and it is well tolerated by patients.

PMID:35660927 | DOI:10.1093/mr/roac057