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Nevin Manimala Statistics

Refining Prognosis in Localized Gastrointestinal Stromal Tumor: Clinical Significance of Phosphatase and Tensin Homolog Low Expression and Gene Loss

JCO Precis Oncol. 2022 Aug;6:e2200129. doi: 10.1200/PO.22.00129.

ABSTRACT

PURPOSE: To investigate the use of PTEN biomarker to improve prognostic stratification in patients with localized gastrointestinal stromal tumor (GIST).

METHODS: PTEN expression and genomic analysis were performed on two independent GIST-60 (n = 60) and GIST-100 (n = 100) cohorts, respectively.

RESULTS: PTEN expression was significantly lower in patients with local and metastatic recurrent tumor compared with those with no recurrence (P = .004). PTEN low expression was significantly associated with poor disease-free survival (DFS) compared with PTEN high expression (43.73 v 117.95 months; P = .0084) and distant metastatic-free survival (DMFS; 57.95 v 117.95 months; P = .0032). PTEN heterozygous loss was observed in approximately 10% of the patients in each cohort and was associated with poor DFS compared with patients with PTEN normal status (27.56 months v not reached [NR]; P < .001) and DMFS (27.56 months v NR; P < .001). Multivariate analysis revealed that PTEN expression was an independent clinical prognosis factor besides tumor size, mitosis index, and location (hazard ratio for DFS: 3.8; P = .033; hazard ratio for DMFS 5.7, P = .01). Furthermore, PTEN low expression was independently associated with poor DMFS in clinically high-risk patients (mDMFS: 42.28 v 65.61 months; P = .0166). In addition, PTEN heterozygous loss was independently associated with poor DMFS in patients at either low/intermediate risk (mDMFS: 18.05 months for PTEN loss v NR for PTEN normal status; P < .001) or at high risk (mDMFS: 27.19 months for PTEN loss v 105.36 months for PTEN normal status; P = .044).

CONCLUSION: PTEN low expression/gene loss is an independent significant prognostic factor and a promising component to strengthen the clinical prognostic tools in patients with localized GIST.

PMID:36001861 | DOI:10.1200/PO.22.00129

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Nevin Manimala Statistics

Bayesian Sample Size Planning Tool for Phase I Dose-Finding Trials

JCO Precis Oncol. 2022 Aug;6:e2200046. doi: 10.1200/PO.22.00046.

ABSTRACT

PURPOSE: Through Bayesian inference, we propose a method called BayeSize as a reference tool for investigators to assess the sample size and its associated scientific property for phase I clinical trials.

METHODS: BayeSize applies the concept of effect size in dose finding, assuming that the maximum tolerated dose can be identified on the basis of an interval surrounding its true value because of statistical uncertainty. Leveraging a decision framework that involves composite hypotheses, BayeSize uses two types of priors, the fitting prior (for model fitting) and sampling prior (for data generation), to conduct sample size calculation under the constraints of statistical power and type I error.

RESULTS: Simulation results showed that BayeSize can provide reliable sample size estimation under the constraints of type I/II error rates.

CONCLUSION: BayeSize could facilitate phase I trial planning by providing appropriate sample size estimation. Look-up tables and R Shiny app are provided for practical applications.

PMID:36001859 | DOI:10.1200/PO.22.00046

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Nevin Manimala Statistics

Growth Effects on Velopharyngeal Anatomy Within the First 2 Years of Life

J Speech Lang Hear Res. 2022 Aug 24:1-12. doi: 10.1044/2022_JSLHR-22-00186. Online ahead of print.

ABSTRACT

PURPOSE: Limited quantitative data exist regarding growth of the velopharynx within the first 2 years of life. The purpose of this study was to (a) quantify changes in velopharyngeal structures due to growth during the first 2 years of life, (b) examine the impact of sex and race within this age range, and (c) provide normative measures for comparison to individuals with cleft palate.

METHOD/DESCRIPTION: A retrospective chart review was completed of all patients up to 24 months of age that underwent magnetic resonance imaging of the head for medical necessity within the past 18 months using a three-dimensional fluid-attenuated inversion recovery sequence. Measurements of the velopharynx were obtained from 200 scans consistent with previous literature. Participants were divided into five groups based on corrected age for comparison. Variables of interest included adenoid depth, angle of origin, effective velopharyngeal ratio, effective velar length, levator veli palatini length, origin-origin distance, pharyngeal depth, sagittal angle, velopharyngeal ratio, velar insertion distance, velar length, and velar thickness.

RESULTS: Velopharyngeal dimensions were significantly different among corrected age groups after controlling for sex and race. Regarding age, analyses revealed significant differences in all variables of interest except effective velopharyngeal ratio. Regarding sex, significant differences were observed for angle of origin, effective velopharyngeal ratio, effective velar length, levator veli palatini muscle length, and velar insertion distance. Regarding race, a significant difference was only observed for angle of origin.

CONCLUSIONS: Results of this study demonstrate growth of velopharyngeal anatomy in normative infants with race and sex effects apparent in children up to 24 months of age. Variable growth trends were observed among different velopharyngeal measures.

PMID:36001858 | DOI:10.1044/2022_JSLHR-22-00186

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Nevin Manimala Statistics

Radial tuberosity anatomy in intramedullar repair of distal biceps tendon ruptures. A radiological study

Acta Orthop Belg. 2022 Jun;88(2):392-398. doi: 10.52628/88.2.9683.

ABSTRACT

The aim of this study was to measure cortex thickness and medullar canal width of the bicipital tuberosity, to evaluate the accessibility of a intramedullar fixation device and the resistance to pullout strengths of the anterior cortex. The final objective was to determine the length of tendon ingrowth size that will be expected when using this surgical technique. A total of 144 computer tomography images of the proximal radius were used. Bone thickness of the anterior and posterior cortex and medullar canal size were measured. The possible ingrowth of the tendon was measured both for an anatomical and non- anatomical reinsertion. Statistical and concordance analyses of results were performed. The average width of the medullar canal was 8,7mm proximal, 7,9mm distal and 7,7mm at the tuberosity. The average posterior and anterior cortex measured respectively 2,5mm and 2,9mm proximal, 3,2mm and 3,2mm distal and 2,8mm and 1,9mm at the radial tuberosity. The possible non-anatomical ingrowth was 7,6 mm on average and the possible anatomical ingrowth was 7,6mm on average. The radial tuberosity anatomy can accommodate the new distal biceps fixation device. The anterior cortex on which the new device relies for support has a similar thickness as the posterior cortex used in bicortical fixation devices which may suggest similar resistance to pull-out strengths. The availability for intra-osseous fixation of the tendon stump may avoids tendon gapping. The intra-osseous length for the tendon stump surpassed reported tendon slippage during mobilization and active contraction of the distal biceps tendon.

PMID:36001849 | DOI:10.52628/88.2.9683

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Nevin Manimala Statistics

The prevalence of frozen shoulder in patients with limited Dupuytren disease

Acta Orthop Belg. 2022 Jun;88(2):387-391. doi: 10.52628/88.2.9933.

ABSTRACT

Evidence from the literature suggests an association between Dupuytren disease and frozen shoulder syndrome, both clinically and histologically. An increased tendency for fibrotic healing after repetitive microtrauma could be an underlying mechanism. However, it remains unclear how strong this association is and if only mild signs of Dupuytren disease would also increase the risk of frozen shoulder. In 61 patients, we examined the hands for signs of Dupuytren disease and the shoulders for pain and limited motion. We found a 21,7% prevalence of frozen shoulder syndrome in patients with signs of Dupuytren disease versus 13,9% in those without. The other way around, in patients with frozen shoulder syndrome the prevalence of Dupuytren disease was 50% versus 36.7% in those without frozen shoulder syndrome. These differences were not statistically significant, contrary to similar research in the literature. However, methodological issues, especially the choice of control group, may explain the differences between our findings and previous studies. We conclude that the clinical association between Dupuytren disease may not be so strong as previously thought, especially in patients with only limited signs of the disease.

PMID:36001848 | DOI:10.52628/88.2.9933

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Nevin Manimala Statistics

Non-contact wound area assessment by digital planimetry using photo editing software

Acta Orthop Belg. 2022 Jun;88(2):368-371. doi: 10.52628/88.2.8215.

ABSTRACT

To objectively assess wound healing utilizing a novel digital photo planimetry method. 58 wounds mostly of traumatic origin were studied. In method I (control or gold standard), a transparent plastic graph paper sheet with 2.5 mm squares was placed on the wound to trace the wound edges. This was scanned and analyzed in Adobe Photoshop (PS6) to estimate the area. In the novel method (method II), we clicked a photo with one-inch lines marked (on either side of the wound). This photo was similarly assessed in PS6. A two-sample t-test was used for analysis. Photos were clicked every third day. The time taken to calculate the resultant area was also noted. 484 photos and 1936 values were analyzed. The mean areas obtained were 10690 mm 2 and 10859 mm 2 respectively by methods I and II. The mean difference was 0.824%, 95% CI [-0.05, 1.60] and p = 0.923. The inter and intra- observer variation was < 2% for all readings. The time taken by the novel method was much lesser than the time-tested method (mean = 82 sec vs 178 sec; p < 0.01). The difference in area by the two methods is not statistically significant. The accuracy of both methods is therefore comparable. Our novel method is easier, more cost-effective, equally accurate, safer and reproducible in comparison with the transparency squares method, especially for flat or 2-dimensional wounds.

PMID:36001845 | DOI:10.52628/88.2.8215

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Nevin Manimala Statistics

Comparison of the WALANT and the PFNB techniques in the surgical treatment of unimalleolar fractures: a prospective study

Acta Orthop Belg. 2022 Jun;88(2):359-367. doi: 10.52628/88.2.8351.

ABSTRACT

The popliteal fossa nerve block (PFNB) technique is one of the most popular anesthesia method in the foot and ankle surgery. The wide awake local anesthesia no tourniquet (WALANT) technique is an local anesthetic method and it has been gaining popularity in orthopedic surgery in recent years. Our aim is to compare the efficacy of the WALANT and the PFNB techniques in pain management. This prospective study included 40 patients with lateral malleolar and medial malleolar fractures. The first group was anesthetized using the WALANT technique; in the second group, PFNB was performed. All patients were evaluated for intrasurgical bleeding amounts, mean arterial pressure, surgery time and VAS scores for presurgical pain, pain during the local anesthetic injection sequence, mean intrasurgical pain, mean postsurgical pain. A total of 40 patients in both groups were successfully operated on with the WALANT and the PFNB techniques. When the two groups were compared, statistically significant differences were observed for mean intrasurgical VAS (p = 0.033), mean postsurgical VAS (p = 0.038) and intrasurgical bleeding (p = 0.006). No significant difference was found in pain scores during anesthetic injection (p = 0.529), mean arterial pressure (p = 0.583) and surgery time (p = 0.277). The PFNB technique is more successful in pain management in the treatment of the unimalleolar fractures. Intrasurgical bleeding amounts were less detected in the WALANT tech- nique. The both techniques are a reliable and suitable anesthetic method in the surgical treatment of uni- malleolar fractures.

PMID:36001844 | DOI:10.52628/88.2.8351

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Nevin Manimala Statistics

Are running stitches needed in DT4 Single Anteromedial Bundle Biological Augmentation transplant preparation?

Acta Orthop Belg. 2022 Jun;88(2):355-358. doi: 10.52628/88.2.8982.

ABSTRACT

Partial running whipstitches are commonly used in DT4 SAMBBA (Single Anteromedial Bundle Biological Augmentation) transplant preparation. We wanted to determine whether or not running whipstitches all over the graft affected the risk of iterative rupture and the overall outcome of the procedure. Two groups of 32 patients comparable in terms of sex, age, sport level and type of sport practiced were recruited in this prospective cohort study. DT4 SAMBBA was performed for all patients by a single surgeon. One cohort was treated with a full length running whipstitches during SAMBBA DT4 transplant preparation (F), the other had a classical SAMBBA DT4 graft preparation (NO F). The ACL RSI, subjective IKDC and KOOS scores were established preoperatively and with a 4 years follow-up. Complication rates (iterative rupture, cyclops syndrome) as well as pre and postoperative score variations were calculated. No statistically significant difference in terms of frequency of iterative rupture or complications could be demonstrated (NO F 9.3% vs F 3.1%, p = 0.61). There was no difference either on score variations compared pre and post operatively. Full running whipstitches of the DT4 SAMBBA transplant does not seem to influence the ligamentoplasty outcomes with a 4 years follow-up.

PMID:36001843 | DOI:10.52628/88.2.8982

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Quadriceps tendon vs hamstring autograft in primary ACL reconstruction – a comparative study with minimum two-year follow-up

Acta Orthop Belg. 2022 Jun;88(2):347-354. doi: 10.52628/88.2.7306.

ABSTRACT

Recently there has been growing interest in the quadriceps tendon (QUAD) as a valid option for reconstruction of the anterior cruciate ligament (ACLR). The aims of the study is to compare the outcomes achieved in anatomic ACLR involving QUAD vs. Hamstring (HT) autografts. A total of 52 consecutive patients underwent an ACLR, 25 patients with QUAD graft and 27 with HT graft. The same surgical technique, fixation method and postoperative protocol were used in both groups. The following parameters were evaluated: functional status (Lysholm, Tegner, subjective IKDC scores), joint stability (Lachman and pivot shift tests), surgical reoperation rate, complications, degree of satisfaction and return to previous level of activity. Descriptive statistics were analysed using the Student’s t-test. Forty four patients were evaluated (20 QUAD, 24 HT), with a mean follow-up of 27.4 months. Two patients were re-operated in the QUAD group (including one ACL revision), and one patient in the HT group required an ACL revision. There were no significant differences between the two groups in postoperative scores: Lysholm (96.05 vs. 96.05), IKDC (86.2 vs. 91.2) and Tegner (6 vs. 5) scales. The percentage of negative Lachman and pivot shift tests was similar in the two groups (45% vs. 50% and 40% vs. 45.8%, respectively). There were no significant differences between the groups in the degree of satisfaction (95.8% vs. 80%, p = .16) or in the percentage who returned to their previous level of activity (62.5% vs. 45%, p = .17). The use of a QUAD graft in ACL reconstruction leads to similar clinical and functional outcomes to those obtained with HT.

PMID:36001842 | DOI:10.52628/88.2.7306

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Nevin Manimala Statistics

The addition of oral Tranexamic acid to knee arthroplasty patients does not further improve blood loss: a double blinded randomized control trial

Acta Orthop Belg. 2022 Jun;88(2):335-341. doi: 10.52628/88.2.8383.

ABSTRACT

Perioperative intravenous (IV) TA has become routine in knee and hip arthroplasty. Less evidence exists on the administration of oral TA in the post- operative period. Our study aims to identify the efficacy and safety of combined perioperative IV and post-operative oral TA on blood loss and Hemoglobin (Hb) drop compared to perioperative IV TA alone. Patients undergoing primary elective knee arthro- plasty at our institution were invited to participate in the study (n=50). A computer-generated randomisation sequence was created online (www.randomization. org), with an allocation ratio of 1:1 and a block size of 50. Group A received perioperative IV TA alone and post-operative oral TA (n= 26) and Group B received perioperative IV TA plus 48 hours additional oral placebo (n= 24). Day 3 total blood loss and Hb drop was calculated. Continuous, normally distributed data (total blood loss) was compared utilising using one-way analysis of variance with post hoc Tukey test. Continuous skewed data (Hb drop) was compared using the Kruskal-Wallis test. P <0.05 was considered statistically significant. Group A demonstrated a trend in decreased total blood loss that was close to statistical significance ( p = 0.072). No difference in Hb drop was identified between the 2 groups. Increased nausea was also observed in Group A. The administration of oral TA to post-operative knee arthroplasty patients does not improve further blood loss compared to patients receiving perioperative IV TA pre-operatively and at wound closure.

PMID:36001840 | DOI:10.52628/88.2.8383