Tag: statistics

J Shoulder Elbow Surg. 2023 May 26:S1058-2746(23)00388-9. doi: 10.1016/j.jse.2023.04.011. Online ahead of print.

ABSTRACT

INTRODUCTION: In high functioning patients, the ceiling effect associated with many patient-reported outcome measures (PROMs) limits the ability to appropriately stratify success. The percent maximal possible improvement (%MPI) was introduced as another evaluation tool, with a proposed threshold of success at 30%. It remains unclear if this threshold correlates with perceived patient success following shoulder arthroplasty. The purpose of this study was to compare the proportion of patients that achieved the minimal clinically important difference (MCID) and %MPI for different outcome scores and to define the %MPI thresholds associated with patient satisfaction following primary reverse shoulder arthroplasty (rTSA).

METHODS: A retrospective review was performed of an international shoulder arthroplasty database between 2003 and 2020. All primary rTSAs performed using a single implant system with minimum 2-year follow-up were reviewed. Pre- and postoperative outcome scores were evaluated for all patients to determine the raw improvement and %MPI. The proportion of patients achieving the MCID and 30% MPI were determined for each outcome score. Thresholds for the minimal clinically important %MPI (MCI-%MPI) were calculated using an anchor-based method for each outcome score and stratified by age and sex.

RESULTS: 2,573 shoulders with a mean follow-up of 47 months were included. Outcome scores with known ceiling effects (SST, SPADI, UCLA) had higher rates of patients achieving the 30% MPI, but not the previously reported MCID. Inversely, outcome scores without significant ceiling effects (Constant and SAS scores) had higher rates of patients achieving the MCID, but not the 30% MPI. The MCI-%MPI differed among outcome scores and mean values were as follows: 33% for the SST, 27% for the Constant score, 35% for the ASES score, 43% for the UCLA score, 34% for the SPADI score, and 30% for the SAS score. The MCI-%MPI increased with greater age for SPADI (p<0.04) and SAS (p<0.01) scores, meaning that patients with higher thresholds required a greater fraction of the possible improvement for a given score to be satisfied, but did not reach statistical significance for other scores. Females had a greater MCI-%MPI for the SAS and ASES scores and a lower MCI-MPI% for the SPADI score.

CONCLUSION: The %MPI offers a simple method to quickly assess improvements across patient outcome scores. However, the %MPI that represents patient improvement after surgery is not uniformly the previously established 30% threshold. Surgeons should utilize score-specific estimates of the MCI-%MPI to gauge success when evaluating patients undergoing primary rTSA.

LEVEL OF EVIDENCE: Basic Science Study; Validation of Outcome Instruments.

PMID:37245623 | DOI:10.1016/j.jse.2023.04.011

J Shoulder Elbow Surg. 2023 May 26:S1058-2746(23)00385-3. doi: 10.1016/j.jse.2023.04.008. Online ahead of print.

ABSTRACT

BACKGROUND: Shoulder arthroplasty, including hemiarthroplasty, reverse and anatomical total shoulder arthroplasty, improves quality of life by reducing shoulder pain and restoring function in patients not only with irreparable rotator cuff tears and/or cuff tear arthropathy but also with osteoarthritis posttraumatic arthritis, proximal humeral fractures, etc. Given the rapid developments in artificial joints and improvements in postoperative outcomes, the number of shoulder arthroplasty surgeries is increasing worldwide. Therefore, we investigated changes in trends over time in Korea.

METHODS: We analyzed the longitudinal changes in the incidence of shoulder arthroplasty including anatomic and reverse total shoulder arthroplasty, hemiarthroplasty, and shoulder revision arthroplasty by changes in the Korean age profile, surgical facilities, and geographical regions using the Korean Health Insurance Review and Assessment Service (HIRA) database from 2010-2020. Data were also collected from the National Health Insurance Service (NHIS) and the Korean Statistical Information Service (KOSIS).

RESULTS: From 2010-2020, the total shoulder arthroplasty rate per 1,000,000 person-years increased from 10.571 to 101.372 (time trend = 1.252; 95% CI 1.233-1.271, p < 0.001). The shoulder hemiarthroplasty rate per 1,000,000 person-years decreased from 6.414 to 3.685 (time trend = 0.933; 95% CI 0.907-0.960, p < 0.001). The shoulder revision arthroplasty rate per 1,000,000 person-years increased from 0.792 to 2.315; the increase was significant (time trend = 1.133; 95% CI 1.101-1.166, p < 0.001).

DISCUSSION: Overall, total shoulder arthroplasty and shoulder revision arthroplasty are increasing and shoulder hemiarthroplasty is decreasing. For both total shoulder arthroplasty and shoulder revision arthroplasty, steep increases are evident in the numbers of patients in their 70s and older than 80 years. The shoulder hemiarthroplasty trend is decreasing regardless of differences in age groups, surgical facilities, and geographical regions. Shoulder revision arthroplasty is preferentially performed in Seoul.

PMID:37245622 | DOI:10.1016/j.jse.2023.04.008

J Shoulder Elbow Surg. 2023 May 26:S1058-2746(23)00384-1. doi: 10.1016/j.jse.2023.04.007. Online ahead of print.

ABSTRACT

BACKGROUND: The purpose of this study was to identify nationwide disparities in the rates of operative management of rotator cuff tears based on race, ethnicity, insurance type, and socioeconomic status.

METHODS: Patients diagnosed with a full or partial rotator cuff tear from 2006-2014 were identified in the Healthcare Cost and Utilization Project’s National Inpatient Sample database using International Classification of Diseases, Ninth Revision (ICD-9) diagnosis codes. Bivariate analysis using chi-square tests and adjusted, multivariable logistic regression models were used to evaluate differences in the rates of operative versus non-operative management for rotator cuff tears.

RESULTS: This study included 46,167 patients. When compared with white patients, adjusted analysis showed that minority race and ethnicity were associated with lower rates of operative management for Black [adjusted odds ratio (AOR): 0.31, 95% confidence interval (CI): 0.29-0.33; p < 0.001], Hispanic [AOR: 0.49, 95% CI: 0.45-0.52; p < 0.001], Asian or Pacific Islander [AOR: 0.72, 95% CI: 0.61-0.84; p < 0.001], and Native American patients [AOR: 0.65, 95% CI: 0.50-0.86; p = 0.002]. In comparison to privately insured patients, our analysis also found that self-payers [AOR: 0.08, 95% CI: 0.07-0.10; p < 0.001], Medicare beneficiaries [AOR: 0.76, 95% CI: 0.72-0.81; p < 0.001], and Medicaid beneficiaries [AOR: 0.33, 95% CI: 0.30-0.36; p < 0.001] had lower odds of receiving surgical intervention. Additionally, relative to those in the bottom income quartile, patients in all other quartiles experienced nominally higher rates of operative repair; these differences were statistically significant for the second quartile [AOR: 1.09, 95% CI: 1.03-1.16; p = 0.004].

CONCLUSION: There are significant nationwide disparities in the likelihood of receiving operative management for rotator cuff tear patients of differing race/ethnicity, payer status, and socioeconomic status. Further investigation is needed to fully understand and address causes of these discrepancies to optimize care pathways.

PMID:37245619 | DOI:10.1016/j.jse.2023.04.007

Pediatr Neurol. 2023 Apr 14;145:11-21. doi: 10.1016/j.pediatrneurol.2023.04.006. Online ahead of print.

ABSTRACT

BACKGROUND: To investigate the activity of the gut-brain axis in the pathogenesis of childhood epilepsy and to define biomarkers capable of assisting with determining new strategies in that context.

METHODS: Twenty children with epilepsy of “unknown etiology” and seven healthy controls in the same age group were included in the study. The groups were compared using a questionnaire. Stool samples were stored in tubes containing DNA/RNA Shield (Zymo Research) with a sterile swab. Sequencing was carried out using the MiSeq System (Illumina). The 16S rRNA sequencing of samples using next-generation sequencing involved V4 variable region polymerase chain reaction amplification concluded by 2 × 250-bp paired-end sequencing of amplicons and at least 50,000 reads (>Q30) per sample. DNA sequences were classified at the genus level using the Kraken program. Bioinformatics and statistical analysis were then performed.

RESULTS: Individuals’ gut microbiota relative abundance values differed between the groups at the genus, order, class, family, and phylum levels. Flavihumibacter, Niabella, Anoxybacillus, Brevundimonas, Devosia, and Delftia were seen only in the control group, whereas Megamonas and Coriobacterium were observed only in the epilepsy group. The linear discriminant analysis effect size method identified 33 taxa as important in differentiating the groups.

CONCLUSIONS: We think that bacterial varieties (such as Megamonas and Coriobacterium) that differ between the two groups can be employed as useful biomarkers in the diagnosis and follow-up of epileptic patients. We also predict that, in addition to epilepsy treatment protocols, the restoration of eubiotic microbiota may increase the success of treatment.

PMID:37245274 | DOI:10.1016/j.pediatrneurol.2023.04.006

Am J Cardiol. 2023 May 26;199:37-43. doi: 10.1016/j.amjcard.2023.04.041. Online ahead of print.

ABSTRACT

There is limited evidence regarding the prognostic value of the 6-minute walk test for patients with advanced heart failure (HF). Accordingly, we studied 260 patients presenting to inpatient cardiac rehabilitation (CR) with advanced HF. The primary outcome was 3-year all-cause mortality after discharge from CR. The association between 6-minute walk distance (6MWD) and the primary outcome was determined using the multivariable Cox regression analysis. To avoid collinearity, 6MWD at admission (6MWD_adm) to CR and 6MWD at discharge (6MWD_disch) from CR were analyzed separately. At multivariable analysis, 4 baseline characteristics (age, ejection fraction, systolic blood pressure, and blood urea nitrogen) were identified as prognostic of the primary outcome (baseline risk model). After adjusting for the baseline risk model, the hazard ratios of 6MWD_adm and 6MWD_disch modeled as per 50-m increase for the primary outcome were 0.92 (95% confidence interval [CI] 0.85 to 0.99, p = 0.035) and 0.93 (95% CI 0.88 to 0.99, p = -017), respectively. After adjusting for the Meta-analysis Global Group in Chronic Heart Failure (MAGGIC) score, the corresponding hazard ratios were 0.91 (95% CI 0.84 to 0.98, p = 0.017) and 0.93 (95% CI 0.88 to 0.99, p = 0.016). The addition of either 6MWD_adm or 6MWD_disch to the baseline risk model or the MAGGIC score yielded a statistically significant increase in global chi-square and in the net proportion of survivors reclassified downward. In conclusion, our data suggest that the distance covered during a 6-minute walk test predicts survival and provides incremental prognostic information on the top of well-established prognostic factors and the MAGGIC risk score in advanced HF.

PMID:37245248 | DOI:10.1016/j.amjcard.2023.04.041

J Physiol Pharmacol. 2023 Feb;74(1). doi: 10.26402/jpp.2023.1.10. Epub 2023 May 23.

ABSTRACT

To observe the evolution of the intestinal microbiota in patients after allogeneic hematopoietic stem cell transplantation (allo-HSCT) and discuss the relationship between the intestinal microbiota and graft-versus-host disease (GVHD). In this study, 11 patients who underwent allo-HSCT in the Aerospace Central Hospital from January 2021 to October 2021 were selected, along with 11 donors. Fecal specimens were collected 7 times: at admission, after pre-treatment, and every 3 weeks after transplantation from patients and once from donors. The composition of the intestinal microbiota and its association with GVHD after allogeneic hematopoietic stem cell transplantation were analyzed by 16S rRNA sequencing. Of the 11 patients, 5 developed GVHD, and 6 did not. The diversity of the intestinal microbiota among GVHD patients first increased and then decreased after transplantation, while that among non-GVHD patients first increased and then tended to be stable. The diversity of the intestinal microbiota among GVHD patients was lower than that among non-GVHD patients before pre-treatment and after transplantation. The taxa diversity of the intestinal microbiota in the non-GVHD group was better than that in the GVHD group before allo-HSCT, and the difference was statistically significant (P<0.05 for OTUs and CHAO1 index). The taxa abundance of Enterococcaceae 2.16% (2.13%, 2.22%) before allo-HSCT was significantly higher than that in the non-GVHD group 1.33% (0.27%, 1.52%), and the difference was statistically significant (P=0.004). There was no significant difference between the GVHD group and the non-GVHD group in the diversity of the intestinal microbiota of donors (P<0.05). The characteristics of the intestinal microbiota in the final sample of patients in the GVHD group were similar to the preoperative structure of the intestinal microbiota. In conclusion: The decrease in the diversity of the intestinal microbiota after HSCT may be a risk factor for the occurrence of GVHD. The presence of Enterococcaceae in the intestinal microbiota may be associated with an increased risk of developing GVHD. The intestinal microbiota reconstitute to be close to the intestinal microbiota composition of the donors in the non-GVHD group.

PMID:37245237 | DOI:10.26402/jpp.2023.1.10

J Physiol Pharmacol. 2023 Feb;74(1). doi: 10.26402/jpp.2023.10.08. Epub 2023 May 23.

ABSTRACT

To identify molecular markers for early diagnosis and new targets for treatment of cervical squamous cell carcinoma. Our study involved 52 carcinoma tissues that were confirmed pathologically as cervical squamous cell carcinoma (CSCC) at the Fourth Hospital of Hebei Medical University in 2021. We obtained 36 control specimens from patients who had undergone hysterectomy for benign uterine diseases in 2021, with no cervical lesions as confirmed by pathology. Total RNA was extracted from all the samples. Reverse transcription and quantitative real-time PCR were performed. Immunohistochemical staining for interferon-stimulated gene 15 (ISG15) protein was performed. Descriptive analyses including mean and standard deviation were used to compare different groups. For data that do not conform to normal distribution, we use Wilcox rank sum test to make statistics to compare different groups with the median and interquartile. Mann Whitney U test was used to compare non-parametric continuous data, and categorical variables were analyzed using chi-square test. Receiver operating characteristic (ROC) curve was used to evaluate the possibility of using ISG15 as a new biomarker for cervical squamous cell carcinoma. Compared with normal cervical tissues, mRNA expression of ISG15 in cervical cancer tissues was significantly lower (P<0.01); mRNA expression was significantly lower in patients with nerve invasion (P<0.05). Difference in ISG15 protein expression was statistically significant (no expression/low expression) in the cancer samples compared to normal tissues (P<0.01). The area under ROC curve was 0.810 (P<0.001) and the sensitivity and specificity were 75% and 54%, respectively. Spearman’s correlation analysis showed that ISG15 mRNA was positively correlated with protein expression (r=0.358, P=0.001). Deficiency of ISG15 may be associated with the occurrence and progression of CSCC. It could be used as a potential tumor marker in research and treatment of CSCC.

PMID:37245235 | DOI:10.26402/jpp.2023.10.08

West Afr J Med. 2023 May 27;40(5):469-475.

ABSTRACT

BACKGROUND: Knowledge and compliance with malaria treatment guidelines are among the major issues affecting treatment outcome for malaria in Nigeria. Primary health care (PHC) facilities are the first point of contact with the national health system for patients with malaria and other diseases.

OBJECTIVE: This study assessed the knowledge and compliance with malaria National Treatment Guidelines (NTG) among PHC workers in Lere local government area of Kaduna State, North western Nigeria.

METHODS: This was a descriptive cross-sectional study conducted among 42 community health workers. The total population of all eligible participants was used for subject selection. Data were analysed with SPSS IBM version 25.0 and STATA/SE 12. The level of statistical significance p-value was set at p<0.05.

RESULTS: The mean age of the respondents was 38.02±9.23 years. Majority of the respondents were males (25; 59.5%) and community health extension workers (CHEWs) (24; 57.1%). Almost one-third (28.6%) of the PHC workers had poor knowledge of the recommendations of the NTG for malaria, while 14.3% had poor compliance with the NTG. Bivariate analysis showed a significant relationship between older age and good knowledge of the NTG ( χ2 =0.03, p=0.04). Multivariate analysis further revealed that the odds for poor knowledge of NTG was 40% higher among CHEWs compared to other health workers (AOR=1.40, 95% CI=0.25-7.93). The odds for good knowledge was lower by 55% among those who had practiced for <10 years compared to >10 years (OR=0.45, 95% CI=0.06-3.32).

CONCLUSION: Poor knowledge and compliance to malaria NTG were commoner among lower cadre (CHEWs) staff with relatively fewer years in PHC practice. There is a need for training, retraining and equitable distribution of the NTG to ensure access and also improve knowledge and utilisation of the NTG for malaria by rural PHC workers.

PMID:37245219

Orv Hetil. 2023 May 28;164(21):811-819. doi: 10.1556/650.2023.32759. Print 2023 May 28.

ABSTRACT

Fragmentation of health data and biomedical research data is a major obstacle for precision medicine based on data-driven decisions. The development of personalized medicine requires the efficient exploitation of health data resources that are extraordinary in size and complexity, but highly fragmented, as well as technologies that enable data sharing across institutions and even borders. Biobanks are both sample archives and data integration centers. The analysis of large biobank data warehouses in federated datasets promises to yield conclusions with higher statistical power. A prerequisite for data sharing is harmonization, i.e., the mapping of the unique clinical and molecular characteristics of samples into a unified data model and standard codes. These databases, which are aligned to a common schema, then make healthcare information available for privacy-preserving federated data sharing and learning. The re-evaluation of sensitive health data is inconceivable without the protection of privacy, the legal and conceptual framework for which is set out in the GDPR (General Data Protection Regulation) and the FAIR (findable, accessible, interoperable, reusable) principles. For biobanks in Europe, the BBMRI-ERIC (Biobanking and Biomolecular Research Infrastructure – European Research Infrastructure Consortium) research infrastructure develops common guidelines, which the Hungarian BBMRI Node joined in 2021. As the first step, a federation of biobanks can connect fragmented datasets, providing high-quality data sets motivated by multiple research goals. Extending the approach to real-word data could also allow for higher level evaluation of data generated in the real world of patient care, and thus take the evidence generated in clinical trials within a rigorous framework to a new level. In this publication, we present the potential of federated data sharing in the context of the Semmelweis University Biobanks joint project. Orv Hetil. 2023; 164(21): 811-819.

PMID:37245207 | DOI:10.1556/650.2023.32759

Hum Genet. 2023 May 28. doi: 10.1007/s00439-023-02568-8. Online ahead of print.

ABSTRACT

Migraine-a painful, throbbing headache disorder-is the most common complex brain disorder, yet its molecular mechanisms remain unclear. Genome-wide association studies (GWAS) have proven successful in identifying migraine risk loci; however, much work remains to identify the causal variants and genes. In this paper, we compared three transcriptome-wide association study (TWAS) imputation models-MASHR, elastic net, and SMultiXcan-to characterise established genome-wide significant (GWS) migraine GWAS risk loci, and to identify putative novel migraine risk gene loci. We compared the standard TWAS approach of analysing 49 GTEx tissues with Bonferroni correction for testing all genes present across all tissues (Bonferroni), to TWAS in five tissues estimated to be relevant to migraine, and TWAS with Bonferroni correction that took into account the correlation between eQTLs within each tissue (Bonferroni-matSpD). Elastic net models performed in all 49 GTEx tissues using Bonferroni-matSpD characterised the highest number of established migraine GWAS risk loci (n = 20) with GWS TWAS genes having colocalisation (PP4 > 0.5) with an eQTL. SMultiXcan in all 49 GTEx tissues identified the highest number of putative novel migraine risk genes (n = 28) with GWS differential expression at 20 non-GWS GWAS loci. Nine of these putative novel migraine risk genes were later found to be at and in linkage disequilibrium with true (GWS) migraine risk loci in a recent, more powerful migraine GWAS. Across all TWAS approaches, a total of 62 putative novel migraine risk genes were identified at 32 independent genomic loci. Of these 32 loci, 21 were true risk loci in the recent, more powerful migraine GWAS. Our results provide important guidance on the selection, use, and utility of imputation-based TWAS approaches to characterise established GWAS risk loci and identify novel risk gene loci.

PMID:37245199 | DOI:10.1007/s00439-023-02568-8