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Nevin Manimala Statistics

Is biceps tenodesis necessary when performing arthroscopic rotator cuff repair in patients older than 55 years?

Arch Orthop Trauma Surg. 2022 Nov 27. doi: 10.1007/s00402-022-04707-8. Online ahead of print.

ABSTRACT

INTRODUCTION: In patients with arthroscopic rotator cuff repair, tenotomy and tenodesis are the most performed surgical procedures for the biceps long head (BLH) pathologies. Controversy continues as to which surgical procedure provides better results. This study aimed to compare the clinical outcomes of tenotomy and tenodesis applied to the biceps long head in patients who underwent arthroscopic rotator cuff repair.

MATERIALS AND METHODS: In our study, the clinical results of 706 patients who underwent arthroscopic rotator cuff repair with tenotomy or tenodesis on the long biceps head were evaluated retrospectively. Rotator cuff repair patients were divided into two groups as single-row and double-row repair patients. The clinical results of patients who underwent tenotomy and tenodesis in single-row (n = 383) and double-row (n = 323) repair groups were compared. The clinical outcomes of the patients who underwent tenotomy and tenodesis without distinction between double/single-row repair were also compared. Preoperative and postoperative clinical evaluations of the patients were made with Constant Shoulder Score (CSS) and visual pain scale (VAS). The presence of the Popeye sign in the arm, tenderness in the bicipital groove, and cramping in the biceps muscle in the postoperative period was evaluated and compared among groups. Preoperative and postoperative clinical results of the patients were compared within the groups.

RESULTS: A total of 706 patients with a mean age of 61.78 ± 20.94 years and a mean follow-up period of 29.15 ± 14.28 months were evaluated. The mean age of the tenodesis group (58.13 ± 8.47) was significantly lower than the tenotomy group (61.52 ± 22.58) (p < 0.05). The mean CSS and VAS mean postoperatively in the tenotomy group (n = 587) were 76.84 ± 12.74 and 2.29 ± 2.78. The postoperative mean CSS and VAS in the tenodesis group (n = 119) were 77.56 ± 11.23 and 2.64 ± 2.70. There was no statistically significant difference between the postoperative clinical scores of patients who underwent tenotomy and patients who underwent tenodesis (p > 0.05). There was no difference between the tenotomy and tenodesis groups regarding Popeye deformity (p = 0.980). Bicipital groove tenderness and cramping in the biceps muscle were significantly higher in the tenodesis group (p < 0.001, < 0.001). Tenodesis was performed in 68, and tenotomy was performed in 315 out of 383 patients who underwent single-row rotator cuff repair. Tenodesis was performed in 51, and tenotomy was performed in 272 of 334 patients who underwent double-row rotator cuff repair. When singe versus double-row groups was compared, there was no significant difference in VAS, CSS, Popeye sing, bicipital groove tenderness, or biceps muscle cramping. When tenotomy versus tenodesis was compared within single- and double-row repair groups, there was no significant difference in VAS or CSS. There was no difference between the tenotomy and tenodesis groups regarding Popeye deformity, but bicipital groove tenderness and muscle cramping were more in tenodesis groups regardless of the repair rows.

CONCLUSIONS: The effect of tenodesis versus tenotomy for BHL pathologies in patients who underwent arthroscopic rotator cuff repair was not significant for clinical scores, but bicipital groove tenderness and biceps muscle cramping were significantly higher in the tenodesis group.

PMID:36436066 | DOI:10.1007/s00402-022-04707-8

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Adherence to Guidelines in Heart Failure, Is It Valid for Elderly Patients?

Isr Med Assoc J. 2022 Nov;24(11):757-762.

ABSTRACT

BACKGROUND: Current guidelines for the treatment of heart failure with reduced ejection fraction (HFrEF) are based on studies that have excluded or underrepresented older patients.

OBJECTIVES: To assess the value of guideline directed medical therapy (GDMT) in HFrEF patients 80 years of age and older.

METHODS: A single-center retrospective study included patients hospitalized with a first and primary diagnosis of acute decompensated heart failure (ADHF) and ejection fraction (EF) of ≤ 40%. Patients 80 years of age and older were stratified into two groups: GDMT, defined as treatment at hospital discharge with at least two drugs of the following groups: beta-blockers, angiotensin converting enzyme inhibitor (ACEI), angiotensin receptor blocker (ARB), or mineralocorticoid antagonists; and a personalized medicine group, which included patients who were treated with up to one of these drug groups. The primary outcomes were 90-day all-cause mortality, 90-day rehospitalization, and 3-years mortality.

RESULTS: The study included 1152 patients with HFrEF. 254 (22%) patients who were at least 80 years old. Of the group, 123 were GDMT at discharge. When GDMT group was compared to the personalized medicine group, there were no statistically significant differences in terms 90-day mortality (17% vs. 13%, P = 0.169), 90-day readmission (51 % vs. 45.6%, P = 0.27), or 3-year mortality (64.5% vs. 63.3%, P = 0.915).

CONCLUSIONS: Adherence to guidelines in the older adult population may not have the same effect as in younger patients who were studied in the randomized clinical trials. Larger prospective studies are needed to further address this issue.

PMID:36436045

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A case-control analysis of the associations between Fibromyalgia Syndrome and Osteoporosis

Isr Med Assoc J. 2022 Nov;24(11):737-740.

ABSTRACT

BACKGROUND: Fibromyalgia syndrome (FMS) is characterized by widespread musculoskeletal pain and tenderness with associated neuropsychological symptoms such as fatigue, unrefreshing sleep, cognitive dysfunction, anxiety, and depression. Osteoporosis is defined as a reduction of bone density. Previous studies to determine an association of FMS with osteoporosis showed mixed results, partially due to small sample sizes and lack of statistical power.

OBJECTIVES: To evaluate the association of FMS with osteoporosis.

METHODS: We conducted a case-control study utilizing the database from Israel’s largest health maintenance organization. FMS patients were compared to age- and sex-matched controls. Data were analyzed using chi-square and t-tests. Multivariable logistic regression models assessed the association between osteoporosis and FMS. Spearman’s rho test was used for correlation.

RESULTS: We utilized data from 14,296 FMS patients and 71,324 age- and sex-matched controls. Spearman’s rho test showed a significant correlation between FMS and osteoporosis (correlation coefficient 0.55, P < 0.001). A logistic regression for osteoporosis showed an odds ratio [OR] of 1.94 (95% confidence interval [95%CI] 1.83-2.06, P < 0.001) for FMS compared to controls and found higher body mass index to be slight protective (OR 0.926, 95%CI 0.92-0.93, P < 0.001).

CONCLUSIONS: There is a significant correlation between FMS and osteoporosis. Early detection of predisposing factors for osteoporosis in FMS patients and implementation of suitable treatments and prevention measures (such as dietary supplements, resistance or weight bearing exercise, and bone-mineral enhancing pharmacological therapy) may reduce both occurrence rate and severity of osteoporosis and its complications, such as fractures.

PMID:36436041

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Use of tranexamic acid in decreasing blood loss during and after delivery among women in Africa: a systematic review and meta-analysis

Arch Gynecol Obstet. 2022 Nov 27. doi: 10.1007/s00404-022-06845-1. Online ahead of print.

ABSTRACT

BACKGROUND: Africa is a developing continent with a high maternal mortality rate. It is beneficial to implement interventions that alleviate the problem. As a result, this systematic review and meta-analysis was carried out to summarize evidence that will assist concerned bodies in proposing strategies to reduce maternal mortality due to post-partum hemorrhage.

METHODS: This systematic review and meta-analysis includes randomized control trials (RCT) studies searched from various databases (PubMed, Web of Sciences, SCOPUS, African Journal Online, Clinical trials, and African indexes Medics). Data synthesis and statistical analysis were conducted using a combination of review manager 5.3 and STATA Version 14 software. The effect measure utilized was the standardized mean difference for estimated mean blood loss and mean hemoglobin level.

RESULTS: This systematic review and meta-analysis includes a total of 3308 women. The pooled standardized mean difference showed that tranexamic acid statistical significantly reduced the estimated amount of blood loss after vaginal delivery (standardized mean difference with 95% CI – 0.93 [- 1.45, – 0.41]) and during and after cesarean delivery (standardized mean difference with 95% CI – 1.93 [- 2.40, – 1.47]).

CONCLUSION: Tranexamic acid has been found to be a good choice for reducing blood loss during and after delivery in Africa regardless of the mode of delivery. Tranexamic acid had no effect on hemoglobin levels before and after delivery. To reduce maternal mortality due to post-partum hemorrhage, it is critical to implement and strengthen interventions aimed at increasing tranexamic acid uptake in Africa.

PMID:36436014 | DOI:10.1007/s00404-022-06845-1

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Comparative analysis of the effects of dalteparin and reviparin on perioperative blood loss in patients with extracapsular hip fractures treated with intramedullary nailing

Med Glas (Zenica). 2023 Feb 1;20(1). doi: 10.17392/1526-22. Online ahead of print.

ABSTRACT

Aim To determine differences between reviparin and dalteparin treatment in patients with extracapsular hip fractures treated with intramedullary nailing and their effects on perioperative blood loss and early postoperative recovery. Methods Retrospective comparative study included 68 patients with extracapsular hip fracture who were divided into dalteparin and reviparin group. Medical records were used to obtain demographic data, laboratory parameters, haemoglobin and haematocrit levels, platelet count, mortality rate and medical complications. Results Out of total 68 patients, 31 were in reviparin and 37 in dalteparin group. Mean age of patients was 70.5 (±14.4) and 76.8 (±8.4) years in reviparin and dalteparin group, respectively (p=0.071). Median values of haemoglobin levels on the first postoperative day were lower in dalteparin group compared to reviparin group (p=0.012). On the first postoperative day haematocrit values were also lower in dalteparin than in reviparin group (p=0.015). Both groups showed an increase in platelet count on the first postoperative day, but without significant difference (p=0.084). There was no statistically significant difference in intrahospital mortality between the groups (6.4% vs. 2.7%; p=0.588). One case of pulmonary embolism was detected in the dalteparin group. Conclusion Low-molecular-weight heparin is the drug of choice in patients with hip fractures for thromboprophylaxis. Due to non-antithrombin-mediated actions, reviparin and dalteparin could have different effects on perioperative blood loss. Both dalteparin and reviparin are safe and effective agents for thromboprophylaxis in patients with proximal femur fractures.

PMID:36435999 | DOI:10.17392/1526-22

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Parameters in predicting the risk of a prolonged hospital stay in patients with acute exacerbation of chronic obstructive pulmonary disease: a single-centre experience

Med Glas (Zenica). 2023 Feb 1;20(1). doi: 10.17392/1514-22. Online ahead of print.

ABSTRACT

Aim To identify clinical and laboratory parameters on admission and/or during a hospital stay that would predict prolonged hospital stay in patients with acute exacerbation of chronic obstructive pulmonary disease (AECOPD). Methods A retrospective cross-sectional study was conducted at the Clinic for Pulmonary Diseases and Tuberculosis, Clinical Centre University of Sarajevo for the period 2019-2021 accounting patients admitted due to AECOPD. The need for hospitalization was evaluated according to the current GOLD criteria and certain clinical parameters. Spirometry testing and laboratory analysis were performed for all patients on the day of admission and on the 10th day of hospital stay. Linear regression was used to show the relationship between multiple independent predictor variables and LOS. Results A total of 50 patients were evaluated during their hospital stay due to AECOPD. Median of LOS was 22.02±1.06, with 90% hospital survival rate. Due to AECOPD the median of LOS in the intensive care unit (ICU) was 4±0.68 days with pH<7.35 in 34% of hospitalized patients. According to spirometry classification on the day of admission, 56% of patients were assigned to group 3 and 16% to group 4 with significant improvement identified on spirometry findings on discharge. Platelets on the day of admission were the only statistically significant positive predictors of the length of hospital stay. Conclusion Identifying chronic obstructive pulmonary disease patients at risk of frequent exacerbations and appropriate disease management could reduce the disease burden.

PMID:36435996 | DOI:10.17392/1514-22

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Early introduction of peanut reduces peanut allergy across risk groups in pooled and causal inference analyses

Allergy. 2022 Nov 27. doi: 10.1111/all.15597. Online ahead of print.

ABSTRACT

BACKGROUND: The LEAP study has shown the effectiveness of early peanut introduction in prevention of peanut allergy (PA). In the EAT study, a statistically significant reduction in PA was present only in per-protocol (PP) analyses, which can be subject to bias.

OBJECTIVE: To combine individual-level data from the LEAP and EAT trials and provide robust evidence on the bias-corrected, causal effect of early peanut introduction.

METHOD: As part of the European Union-funded iFAAM project, this pooled analysis of individual paediatric patient data combines and compares effectiveness and efficacy estimates of oral tolerance induction among different risk strata and analysis methods.

RESULTS: An intention-to-treat (ITT) analysis of pooled data showed a 75% reduction in PA (p<0.0001) among children randomized to consume peanut from early infancy. A protective effect was present across all eczema severity groups, irrespective of enrolment sensitization to peanut, and across different ethnicities. Earlier age of introduction was associated with improved effectiveness of the intervention. In the pooled PP analysis, peanut consumption reduced the risk of PA by 98% (p<0.0001). A causal inference analysis confirmed the strong PP effect (89% average treatment effect relative risk reduction p<0.0001). A multivariable causal inference analysis approach estimated a large (100%) reduction in PA in children without eczema (p=0.004).

CONCLUSION: We demonstrate a significant reduction in PA with early peanut introduction in a large group of pooled, randomized participants. This significant reduction was demonstrated across all risk subgroups, including children with no eczema. Furthermore, our results point to increased efficacy of the intervention with earlier age of introduction.

PMID:36435990 | DOI:10.1111/all.15597

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Association of lipid accumulation products with testosterone deficiency in adult American men: A cross-sectional study

Andrology. 2022 Nov 27. doi: 10.1111/andr.13355. Online ahead of print.

ABSTRACT

PURPOSE: Testosterone deficiency and changes in testosterone levels are important in men’s health and may be associated with fat accumulation. In order to investigate the connection between testosterone and fat accumulation in adult males, we employed lipid accumulation product (LAP) and compared it to TyG and HOMA-IR.

MATERIALS AND METHODS: A intersecting surface research of participators from 2013-2014was carried out using NHANES, in addition, participants from 2015 to 2016 were selected. Using multivariate adjusted logistic regression, the connection between LAP, testosterone levels, and testosterone insufficiency was investigated, smoothed curve fitting to integrate non-linear relationships, and subgroup analysis to identify sensitive populations.

RESULTS: After removing all potential confounders, testosterone levels in 1651 subjects tended to decrease with increasing continuous variable LAP (β = -0.49, 95% CI [-0.77, -0.22], p = 0.0005) and adding the chance of testosterone deficiency (OR = 1.01, 95% CI [1.01,1.01], p < 0.0001). In the LAP quartile, testosterone levels decreased the most (β = -77.65, 95% CI [-110.99, -44.31], p <0.0001) and the risk of testosterone deficiency was highest (OR = 2.76, 95% CI [1.47, 5.20], p = 0.0016). The AUC values were 0.718(95% CI: 0.688-0.750) for LAP, 0.723 (95% CI: 0.689-0.756) for HOMA-IR, and 0.673(95% CI: 0.640-0.708) for TyG, with no statistical difference between LAP and HOMA-IR comparisons. The cut-off value of LAP ≥ 52.408 predicted testosterone deficiency with good sensitivity and specificity.

CONCLUSION: Higher LAP was linked to a higher incidence of testosterone loss and inadequate, especially in hypertensive and nonsmoker. LAP is a better predictor of testosterone deficiency than TyG and does not differ significantly from the HOMA-IR phase. This article is protected by copyright. All rights reserved.

PMID:36435978 | DOI:10.1111/andr.13355

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Design Considerations for Two Stage Enrichment Clinical Trials

Biometrics. 2022 Nov 27. doi: 10.1111/biom.13805. Online ahead of print.

ABSTRACT

When there is a predictive biomarker, enrichment can focus the clinical trial on a benefiting subpopulation. We describe a two-stage enrichment design, in which the first stage is designed to efficiently estimate a threshold and the second stage is a “phase III-like” trial on the enriched population. The goal of this paper is to explore design issues: sample size in stages 1 and 2, and re-estimation of the stage 2 sample size following stage 1. By treating these as separate trials, we can gain insight into how the predictive nature of the biomarker specifically impacts the sample size. We also show that failure to adequately estimate the threshold can have disastrous consequences in the second stage. While any bivariate model could be used, we assume a continuous outcome and continuous biomarker, described by a bivariate normal model. The correlation coefficient between the outcome and biomarker is the key to understanding the behavior of the design, both for predictive and prognostic biomarkers. Through a series of simulations we illustrate the impact of model misspecification, consequences of poor threshold estimation, and requisite sample sizes that depend on the predictive nature of the biomarker. Such insight should be helpful in understanding and designing enrichment trials. This article is protected by copyright. All rights reserved.

PMID:36435977 | DOI:10.1111/biom.13805

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Theoretical insight into the acidity and cooperativity effect of the LLM-105∙(HNO3)2 system

J Mol Model. 2022 Nov 26;28(12):401. doi: 10.1007/s00894-022-05376-5.

ABSTRACT

In order to reveal the nature of the acidity in explosive product, the acidities and cooperativity effects from the intermolecular H-bonding interactions in the LLM-105∙∙∙(HNO3)2 ternary systems were investigated at the B3LYP/6-311 + + G** and M062X/6-311 + + G** levels, with the integral equation formalism polarized continuum model (IEFPCM) based on the self-consistent-reaction-field. The results show that for the ternary systems, the intermolecular H-bonding interactions are stronger than those in the binary complexes, resulting in the lower [H+] concentrations and larger pKa1 values upon the ternary-complex formations. However, there is no obvious correlation between the acidities and cooperativity effects or APT charges of the H atoms involving the H-bonds. Surface electrostatic potential (ESP) and reduced density gradient are used to reveal the nature of the H-bond and acidity. Interestingly, the acidity is closely related to the ESPs of the H atom (VS,H) involving the intermolecular H-bond, but not to the statistical quantities. This is mainly because both acidity and VS,H are the local properties of system, whereas the cooperativity and statistical quantity of ESP are the global property.

PMID:36435941 | DOI:10.1007/s00894-022-05376-5