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Nevin Manimala Statistics

Identification of protective and ‘at risk’ HLA genotypes for the development of pseudotumours around metal-on-metal hip resurfacings

Bone Jt Open. 2023 Mar 14;4(3):182-187. doi: 10.1302/2633-1462.43.BJO-2023-0003.R1.

ABSTRACT

Hip resurfacing remains a potentially valuable surgical procedure for appropriately-selected patients with optimised implant choices. However, concern regarding high early failure rates continues to undermine confidence in use. A large contributor to failure is adverse local tissue reactions around metal-on-metal (MoM) bearing surfaces. Such phenomena have been well-explored around MoM total hip arthroplasties, but comparable data in equivalent hip resurfacing procedures is lacking. In order to define genetic predisposition, we performed a case-control study investigating the role of human leucocyte antigen (HLA) genotype in the development of pseudotumours around MoM hip resurfacings. A matched case-control study was performed using the prospectively-collected database at the host institution. In all, 16 MoM hip resurfacing ‘cases’ were identified as having symptomatic periprosthetic pseudotumours on preoperative metal artefact reduction sequence (MARS) MRI, and were subsequently histologically confirmed as high-grade aseptic lymphocyte-dominated vasculitis-associated lesions (ALVALs) at revision surgery. ‘Controls’ were matched by implant type in the absence of evidence of pseudotumour. Blood samples from all cases and controls were collected prospectively for high resolution genetic a nalysis targeting 11 separate HLA loci. Statistical significance was set at 0.10 a priori to determine the association between HLA genotype and pseudotumour formation, given the small sample size. Using a previously-reported ALVAL classification, the majority of pseudotumour-positive caseswere found to have intermediate-grade group 2 (n = 10; 63%) or group 3 (n = 4; 25%) histological findings. Two further patients (13%) had high-grade group 4 lesions. HLA-DQB1*05:03:01 (p = 0.0676) and HLA-DRB1*14:54:01 (p = 0.0676) alleles were significantly associated with a higher risk of pseudotumour formation, while HLA-DQA1*03:01:01 (p = 0.0240), HLA-DRB1*04:04:01 (p = 0.0453), HLA-C*01:02:01 (p = 0.0453), and HLA-B*27:05:02 (p = 0.0855) were noted to confer risk reduction. These findings confirm the association between specific HLA genotypes and the risk of pseudotumour development around MoM hip resurfacings. Specifically, the two ‘at risk’ alleles (DQB1*05:03:01 and DRB1*14:54:01) may hold clinical value in preoperative screening and prospective surgical decision-making.

PMID:37051827 | DOI:10.1302/2633-1462.43.BJO-2023-0003.R1

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The impact of cement fixation on early mortality in arthroplasty for hip fracture

Bone Jt Open. 2023 Mar 16;4(3):198-204. doi: 10.1302/2633-1462.43.BJO-2023-0006.R1.

ABSTRACT

Cementing in arthroplasty for hip fracture is associated with improved postoperative function, but may have an increased risk of early mortality compared to uncemented fixation. Quantifying this mortality risk is important in providing safe patient care. This study investigated the association between cement use in arthroplasty and mortality at 30 days and one year in patients aged 50 years and over with hip fracture. This retrospective cohort study used linked data from the Australian Hip Fracture Registry and the National Death Index. Descriptive analysis and Kaplan-Meier survival curves tested the unadjusted association of mortality between cemented and uncemented procedures. Multilevel logistic regression, adjusted for covariates, tested the association between cement use and 30-day mortality following arthroplasty. Given the known institutional variation in preference for cemented fixation, an instrumental variable analysis was also performed to minimize the effect of unknown confounders. Adjusted Cox modelling analyzed the association between cement use and mortality at 30 days and one year following surgery. The 30-day mortality was 6.9% for cemented and 4.9% for uncemented groups (p = 0.003). Cement use was significantly associated with 30-day mortality in the Kaplan-Meier survival curve (p = 0.003). After adjusting for covariates, no significant association between cement use and 30-day mortality was shown in the adjusted multilevel logistic regression (odd rati0 (OR) 1.1, 95% confidence interval (CI) 0.9 to 1.5; p = 0.366), or in the instrumental variable analysis (OR 1.0, 95% CI 0.9 to 1.0, p=0.524). There was no significant between-group difference in mortality within 30days (hazard ratio (HR) 0.9, 95% CI 0.7to 1.1; p = 0.355) or one year (HR 0.9 95% CI 0.8 to 1.1; p = 0.328) in the Cox modelling. No statistically significant difference in patient mortality with cement use in arthroplasty was demonstrated in this population, once adjusted for covariates. This study concludes that cementing in arthroplasty for hip fracture is a safe means of surgical fixation.

PMID:37051818 | DOI:10.1302/2633-1462.43.BJO-2023-0006.R1

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The effect of ethnicity on the age-related changes of spinopelvic characteristics: a systematic review

Bone Joint Res. 2023 Apr 1;12(4):231-244. doi: 10.1302/2046-3758.124.BJR-2022-0335.R1.

ABSTRACT

Spinopelvic characteristics influence the hip’s biomechanical behaviour. However, to date there is little knowledge defining what ‘normal’ spinopelvic characteristics are. This study aims to determine how static spinopelvic characteristics change with age and ethnicity among asymptomatic, healthy individuals. This systematic review followed the Preferred Reporting Items for Systematic Review and Meta-Analyses guidelines to identify English studies, including ≥ 18-year-old participants, without evidence of hip or spine pathology or a history of previous surgery or interventional treatment, documenting lumbar lordosis (LL), sacral slope (SS), pelvic tilt (PT), and pelvic incidence (PI). From a total of 2,543 articles retrieved after the initial database search, 61 articles were eventually selected for data extraction. When all ethnicities were combined the mean values for LL, SS, PT, and PI were: 47.4° (SD 11.0°), 35.8° (SD 7.8°), 14.0° (SD 7.2°), and 48.8° (SD 10°), respectively. LL, SS, and PT had statistically significant (p < 0.001) changes per decade at: -1.5° (SD 0.3°), -1.3° (SD 0.3°), and 1.4° (SD 0.1°). Asian populations had the largest age-dependent change in LL, SS, and PT compared to any other ethnicity per decade at: -1.3° (SD 0.3°) to -0.5° (SD 1.3°), -1.2° (SD 0.2°) to -0.3° (SD 0.3°), and 1.7° (SD 0.2°) versus 1.1° (SD 0.1°), respectively. Ageing alters the orientation between the spine and pelvis, causing LL, SS, and PT to modify their orientations in a compensatory mechanism to maintain sagittal alignment for balance when standing. Asian populations have the largest degree of age-dependent change to their spinopelvic parameters compared to any other ethnicity, likely due to their lower PI.

PMID:37051815 | DOI:10.1302/2046-3758.124.BJR-2022-0335.R1

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Effect of multifactorial intensive treatment in patients with diabetic kidney disease: a meta-analysis with trial sequential analysis

Diabetes Obes Metab. 2023 Apr 12. doi: 10.1111/dom.15093. Online ahead of print.

ABSTRACT

AIM: This meta-analysis was performed to assess the efficacy and safety of multifactorial intensive treatment (MT) in patients with diabetic kidney disease (DKD).

METHODS: We systematically searched PubMed, Embase and Web of science from their inception to February 2023 to identify randomized control trials (RCTs) evaluating the effect and safety of MT in patients with DKD. The quality of included RCTs was assessed using the risk of bias tool. The outcomes were expressed as hazard ratios (HR), risk ratio (RR) or weight mean difference (WMD) with 95% confidence intervals (95% CI), with a meta-analysis of a fixed-effect or random-effect model.

RESULTS: Five RCTs were included for data analysis. The pooled analysis showed that, MT was associated with significant reductions in all-cause mortality (HR=0.75, 95%CI: 0.60, 0.93; P=0.008) and cardiovascular event disease (CVD) rate (HR=0.55, 95%CI: 0.44, 0.68; P<0.001). MT significantly decreased the retinopathy progression (HR=0.79, 95%CI: 0.66, 0.95; P=0.011), progression of macroalbuminuria (HR=0.64, 95%CI: 0.43, 0.95; P=0.027) and progression of microalbuminuria (HR=0.69, 95%CI: 0.56, 0.86; P=0.001). In addition, MT was not associated with an increased risk of all adverse events (RR=1.00, 95%CI: 0.97, 1.03; P=0.830) and all severe adverse events (RR=0.92, 95%CI: 0.74, 1.15; P=0.478), and the statistical power was confirmed by trial sequential analysis.

CONCLUSION: The present study suggested that MT had a remarkable benefit on the risk of all-cause mortality and CVD in patients with DKD. Our results were promising, but had certain limitations, which warrants additional large-scale RCTs to validate our findings. This article is protected by copyright. All rights reserved.

PMID:37046362 | DOI:10.1111/dom.15093

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Clinico-pathologic relationships with Ki67 and its change with short-term aromatase inhibitor treatment in primary ER + breast cancer: further results from the POETIC trial (CRUK/07/015)

Breast Cancer Res. 2023 Apr 12;25(1):39. doi: 10.1186/s13058-023-01626-3.

ABSTRACT

PURPOSE: Ki67 assessed at diagnosis (Ki67baseline) is an important prognostic factor in primary oestrogen receptor-positive (ER +) breast cancer. Proportional change in Ki67 after 2 weeks (∆Ki672week) is associated with clinical benefit from endocrine therapies and residual Ki67 (Ki672week) with recurrence-free survival. The aim was to define the association between Ki67baseline and after aromatase inhibitor (AI) exposure ∆Ki672week and Ki672week with key prognostic and biologic factors utilising data from the POETIC study.

PATIENTS AND METHODS: In POETIC 4480 postmenopausal patients with primary ER and/or PgR + breast cancer were randomised 2:1 to 2 weeks’ presurgical AI (anastrozole or letrozole) or no presurgical treatment (control). Ki67 was measured centrally in core-cut biopsies taken prior to AI and in core-cuts or the excision biopsy at surgery. Relationships between the Ki67 and biologic factors were explored using linear regression.

RESULTS: Established associations of Ki67baseline with biologic factors including PgR status, tumour grade, tumour size, histological subtype, nodal status, and vascular invasion were confirmed in the HER2- subpopulation. In the HER2 + subpopulation only grade and tumour size were significantly associated with Ki67baseline. In control group Ki672week was 18% lower than Ki67baseline (p < 0.001) when Ki672week was measured in excision biopsies but not when measured in core-cuts. Median suppression by AIs (∆Ki672week) was 79.3% (IQR: -89.9 to -54.6) and 53.7% (IQR: -78.9 to -21.1) for HER2-negative and HER2-positive cases, respectively. Significantly less suppression occurred in PgR- vs PgR + and HER2 + vs HER2- tumours which remained apparent after adjustment for 2-week sample type.

CONCLUSIONS: The magnitude of this study allowed characterisation of relationships between Ki67baseline, ∆Ki672week and Ki672week with high degrees of confidence providing a reference source for other studies. Lower values of Ki67 occur when measured on excision biopsies and could lead to apparent but artefactual decreases in Ki67: this should be considered when either ∆Ki672week or Ki672week is used in routine clinical practice to aid treatment decisions or in clinical trials assessing new drug therapies.

PMID:37046348 | DOI:10.1186/s13058-023-01626-3

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Investigating the factors affecting myopia in retinopathy of prematurity after laser treatment

Int J Retina Vitreous. 2023 Apr 12;9(1):27. doi: 10.1186/s40942-023-00456-x.

ABSTRACT

BACKGROUND: We investigated the effect of the number of laser shots applied on the myopic variables to elucidate the mechanism of myopia development in laser-treated retinopathy of prematurity (ROP) eyes.

METHODS: A total of 33 eyes of 17 infants with ROP who underwent laser treatment were included in the analysis. Cycloplegic retinoscopic refraction testing was carried out and the spherical equivalent (SE) was calculated. Relationships between SE and various variables (including the number of laser shots applied) were examined. In addition, an age-matched control group without ROP was prepared and ocular structural parameters were compared.

RESULTS: Although there was no statistical difference in axial length (AL) between two groups (p = 0.88), SE was significantly more myopic in the ROP group (p < 0.001). SE was associated with AL, corneal refraction (CR), and crystalline lens power (CLP) in the ROP group. Of these three factors (AL, CR, and CLP), CLP and the number of laser shots applied were significantly correlated (p = 0.003); however, no correlations were observed between the number of laser shots and AL or CR (p = 0.15 and 0.10, respectively). Very similar tendency was observed in the analysis of the difference between right and left eyes in each child.

CONCLUSIONS: In laser-treated ROP eyes, AL, CR, and CLP were related to the degree of myopia. Moreover, the number of shots applied also affected the myopic status in laser-treated ROP eyes. Among AL, CR, and CLP, only CLP was correlated with the laser shots applied.

PMID:37046346 | DOI:10.1186/s40942-023-00456-x

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Metastasis pattern and prognosis in children with neuroblastoma

World J Surg Oncol. 2023 Apr 12;21(1):130. doi: 10.1186/s12957-023-03011-y.

ABSTRACT

BACKGROUND: We aimed to investigate the different metastases and prognoses of neuroblastoma (NB) and determine the risk factors of metastasis.

METHOD: Data of 1224 patients with NB were obtained from the Surveillance, Epidemiology and End Results database (2010-2018). Pearson’s chi-square test, Kaplan-Meier analysis, multivariable logistic regression and Cox regression analysis were used to determine the factors associated with prognosis.

RESULTS: The overall incidence of NB was an age-adjusted rate of 8.2 patients per 1,000,000 children. In total, 1224 patients were included in our study, with 599 patients (48.9%) exhibiting distant metastases. Compared to patients with non-metastatic NB, a greater proportion of patients with metastatic NB were under 1 year, male, had an adrenal primary site, unilateral tumour, a tumour size > 10 cm, neuroblastoma-not otherwise specified (NB-NOS), second malignant neoplasms and were more likely to choose radiotherapy and chemotherapy. Multivariate Cox regression showed that metastasis was an independent risk factor for overall survival (OS) and cancer-specific survival (CSS). The survival rate of non-metastatic patients with NB was better than those with metastasis (OS: hazard ratio (HR): 0.248, P < 0.001; CSS: HR: 0.267, P < 0.001). The bone and liver were the two most common isolated metastatic sites in NB. However, no statistical difference was observed in OS and CSS between the only bone metastasis group, only liver metastasis group and bone metastasis combined with liver metastasis group (all P > 0.05). Additionally, age at diagnosis > 1 year (odds ratio (OR): 3.295, P < 0 .001), grades III-IV (OR: 26.228, P < 0 .001) and 5-10 cm tumours (OR: 1.781, P < 0 .001) increased the risk of bone metastasis of NB. Moreover, no surgical treatment (OR: 2.441, P < 0 .001) increased the risk of liver metastasis of NB.

CONCLUSION: Metastatic NB has unique clinicopathological features, with the bone and liver as the most common single metastatic sites of NB. Therefore, more aggressive treatment is recommended for high-risk children with NB displaying distant metastases.

PMID:37046344 | DOI:10.1186/s12957-023-03011-y

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Early and mid-term outcomes of off-pump versus on-pump coronary artery bypass surgery in patients with triple-vessel coronary artery disease: a randomized controlled trial

J Cardiothorac Surg. 2023 Apr 13;18(1):140. doi: 10.1186/s13019-023-02258-6.

ABSTRACT

BACKGROUND AND AIM OF THE STUDY: Several studies have compared early and late outcomes of on-pump coronary artery bypass grafting (CABG) and off-pump CABG. However, there is still an ongoing debate on this matter, especially in patients with triple-vessel coronary artery disease (3VD).

METHODS: We randomly assigned 274 consecutive patients with 3VD to two equal groups to undergo on-pump CABG or off-pump CABG. The primary outcome was major adverse cardiac and cerebrovascular events (MACCE), including all-cause mortality, acute coronary syndrome, stroke or transient ischemic attack, and the need for repeat revascularization. The secondary outcomes were postoperative infection, ventilation time, ICU admission duration, hospital stay length, and renal failure after surgery.

RESULTS: The median follow-up duration was 31.2 months (range 24.6-35.2 months). The mean age of patients was 61.4 ± 9.3 years (range: 38-86), and 207 (78.7%) were men. There were 15 (11.2%) and 9 (7.0%) MACCE occurrences in on-pump and off-pump groups, respectively (P value = 0.23). MACCE components including all-cause death, non-fatal MI, CVA, and revascularization did not significantly differ between on-pump and off-pump groups. We observed no difference in the occurrence of MACCE between off-pump and on-pump groups in multivariable regression analysis (HR = 0.57; 95% CI 0.24-1.32; P value = 0.192). There were no statistical differences in postoperative outcomes between the off-pump and on-pump CABG groups.

CONCLUSIONS: Off-pump CABG is an equal option to on-pump CABG for 3VD patients with similar rates of MACCE and postoperative complications incidence when surgery is performed in the same setting by an expert surgeon in both methods. (IRCT20190120042428N1).

PMID:37046338 | DOI:10.1186/s13019-023-02258-6

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Vaccine cold chain management practice and associated factors among health professionals in Ethiopia: systematic review and meta-analysis

J Pharm Policy Pract. 2023 Apr 12;16(1):55. doi: 10.1186/s40545-023-00560-1.

ABSTRACT

BACKGROUND: Administration of potent vaccine in a manner of well-maintained cold chain system is one of the public health focus areas in developing regions of the world. Health professionals’ adherence towards good vaccine cold chain management practices is an important element to ensure potent vaccine reached to users. Studies on health professionals’ practice on vaccine cold chain maintenance and associated factors in Ethiopia have shown wide variations. The aim of this systematic review and meta-analysis is to produce the overall/pooled prevalence of health professionals’ good vaccine cold chain management practice and to identify its associated factors in Ethiopia.

METHODS: Systematic review and meta-analysis was conducted on vaccine cold chain management practice and associated factors among health professionals in Ethiopia. Literature search was made on international data bases using medical subject heading and key words. Data were extracted using Microsoft excel and imported to STATA version 17 for analysis. Heterogeneity was checked using Cochrane Q test and I2 statistics. Weighted inverse variance random effect model was used to estimate the pooled level of good vaccine cold chain management practice among health professionals. Publication bias was checked using funnel plot and using Egger’s test.

RESULTS: A total of ten studies were included in the review. The overall/pooled prevalence of good vaccine cold chain management practice in Ethiopia is 27.48% with 95% CI (25.70-29.26). Having good knowledge on vaccine cold chain management AOR 2.27 95% CI (1.72-2.99), and have received on-job training AOR 6.64 95% CI (4.60-9.57) are factors positively associated with vaccine cold chain management practice among health professionals in Ethiopia.

CONCLUSION: The overall/pooled prevalence of good vaccine cold chain management practice is much lower than the expected level. There is a need to plan on-job trainings for all vaccine handlers and other health professionals supposed to work on vaccination program.

PMID:37046331 | DOI:10.1186/s40545-023-00560-1

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Early discontinuation of long-acting reversible contraceptives and associated factors among women discontinuing long-acting reversible contraceptives at national referral hospital, Kampala-Uganda; a cross-sectional study

Contracept Reprod Med. 2023 Apr 12;8(1):27. doi: 10.1186/s40834-023-00223-1.

ABSTRACT

BACKGROUND: High levels of unmet need for contraception and unwanted pregnancies are high in developing countries despite efforts to reduce them. Long-acting reversible contraceptive (LARC) methods are more than 99% effective in preventing pregnancy. Discontinuation of LARC within the first year of initiation contributes to the high levels of unmet need. This study aimed to determine the prevalence and factors associated with the first-year discontinuation of LARC at Kawempe National Referral hospital.

METHODS: A facility-based cross-sectional study was conducted from February 2020 to June 2021. We consecutively recruited 354 participants who discontinued a LARC (intrauterine device {IUD} and sub-dermal implant) during the study period after informed written consent. Data on duration of use, reasons for discontinuation, and factors associated were collected using a face-to-face interviewer-administered questionnaire and review of client records. Early LARC discontinuation was defined as the termination of the contraception within the first 12 months of use. Data were entered using SPSS version 14/0 and analyzed in STATA version 15. Prevalence was expressed as a proportion while logistic regression was used to assess factors associated with early LARC discontinuation. Variables with a p-value of < 0.05 were considered statistically significant.

RESULTS: The proportion of first-year discontinuation of LARC was 29%. Women Age less than 25 years (OR = 5.07; 95% CI: 1.1-24.8) and those who desired a family size of fewer than four children (OR = 3.19; 95%CI: 1.2-8.7 ) were more likely to discontinue the LARC within 12 months of initiation after multivariate analysis. Method-related reasons for removal were painful menstrual cramps for implants, recurrent infections for IUDs, and a non-side effect reason was the desire to get pregnant.

CONCLUSION: A high proportion of women discontinue LARC within 12 months following initiation. Young adults and those who desire small families are more likely to have first-year discontinuation of LARC. We recommend age-specific counseling for patients receiving the LARC and further studies looking at the depth analysis of reasons for the first-year discontinuation.

PMID:37046325 | DOI:10.1186/s40834-023-00223-1