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Nevin Manimala Statistics

Time-dependent prognostic accuracy measures for recurrent event data

Biometrics. 2024 Oct 3;80(4):ujae150. doi: 10.1093/biomtc/ujae150.

ABSTRACT

In many clinical contexts, the event of interest could occur multiple times for the same patient. Considerable advancement has been made on developing recurrent event models based on or that use biomarker information. However, less attention has been given to evaluating the prognostic accuracy of a biomarker or a composite score obtained from a fitted recurrent event-rate model. In this manuscript, we propose novel measures to characterize the prognostic accuracy of a marker measured at baseline in the presence of recurrent events. The proposed estimators are based on a semiparametric frailty model that accounts for the informativeness of a marker and unobserved heterogeneity among patients with respect to the rate of event occurrence. We investigate the asymptotic properties of the proposed accuracy estimators and demonstrate these estimators’ finite sample performance through simulation studies. The proposed estimators have minimal bias and appropriate coverage. The estimators are applied to evaluate the performance of a baseline forced expiratory volume, a measure of lung capacity, for repeated episodes of pulmonary exacerbations in patients with cystic fibrosis.

PMID:39723565 | DOI:10.1093/biomtc/ujae150

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Nevin Manimala Statistics

Semi-parametric sensitivity analysis for trials with irregular and informative assessment times

Biometrics. 2024 Oct 3;80(4):ujae154. doi: 10.1093/biomtc/ujae154.

ABSTRACT

Many trials are designed to collect outcomes at or around pre-specified times after randomization. If there is variability in the times when participants are actually assessed, this can pose a challenge to learning the effect of treatment, since not all participants have outcome assessments at the times of interest. Furthermore, observed outcome values may not be representative of all participants’ outcomes at a given time. Methods have been developed that account for some types of such irregular and informative assessment times; however, since these methods rely on untestable assumptions, sensitivity analyses are needed. We develop a sensitivity analysis methodology that is benchmarked at the explainable assessment (EA) assumption, under which assessment and outcomes at each time are related only through data collected prior to that time. Our method uses an exponential tilting assumption, governed by a sensitivity analysis parameter, that posits deviations from the EA assumption. Our inferential strategy is based on a new influence function-based, augmented inverse intensity-weighted estimator. Our approach allows for flexible semiparametric modeling of the observed data, which is separated from specification of the sensitivity parameter. We apply our method to a randomized trial of low-income individuals with uncontrolled asthma, and we illustrate implementation of our estimation procedure in detail.

PMID:39723564 | DOI:10.1093/biomtc/ujae154

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Nevin Manimala Statistics

Long term surgical outcomes following renal transplantation in Aotearoa New Zealand: the South Island Chapter

ANZ J Surg. 2024 Dec 26. doi: 10.1111/ans.19372. Online ahead of print.

ABSTRACT

BACKGROUND: Over the last decade, there has been a steady increase in the number of patients diagnosed with end stage renal failure (ESRF). Renal transplant remains the best available treatment for ESRF. The aim of this study is to assess the surgical outcomes following renal transplantation in a single tertiary centre in Aotearoa New Zealand.

METHODS: A retrospective observational study was performed in Christchurch Hospital. All live-related and deceased donor adult renal transplants performed between 1 January 2009 and 1 January 2023 were included in the study. Patients were identified from the local transplant database (Proton) and data were extracted from both electronic and hardcopy records.

RESULT: There were 227 live-related and 150 deceased donor renal transplants performed over the study period. Median BMI in the study cohort was 27 kg/m2. The most common aetiology of ESRF was glomerular disease. Obese (BMI 30-40 kg/m2) patients had a higher incidence of post-operative complications. Ethnicity was shown to be associated with a higher incidence of post-operative complications. This was only statistically significant in the Pacific Islander group (P = 0.013). Live-related donor graft survival was 97% at 1 year and 93% at 5 years while deceased donor graft survival was 95% at 1 year and 92% at 5 years.

CONCLUSION: This study showed that graft outcome in our cohort was comparable to international data. However, further studies are needed to assess whether specific ethnic groups are truly linked to a higher incidence of post-operative complications.

PMID:39723559 | DOI:10.1111/ans.19372

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Nevin Manimala Statistics

Pointe Assessment Screen Shah Edison (PASSE) for Pointe Readiness: A Pilot Study

J Dance Med Sci. 2024 Dec 26:1089313X241307736. doi: 10.1177/1089313X241307736. Online ahead of print.

ABSTRACT

Introduction: As demanding as dancing en pointe is, no universal standard exists to determine when a ballet dancer is ready to advance to this next level. The goal of this study was to provide preliminarily tested and reliable guidelines for a screening tool that can be used to determine (1) if a dancer is ready for pointe, (2) reasons why a dancer may not be ready, and (3) areas for improvement to guide training and preparation. Methods: Participants: Seventeen dancers aged 9 to 17 years with a minimum 4 years of ballet and who were either possibly ready for pointe or had been in pointe class less than 3 months participated in this study. Study Design: Dancers were prospectively assessed by two physicians using the Pointe Assessment Screening Shah Edison (PASSÉ) tool for assessing pointe readiness. Interrater reliability and the relationship of individual tests to overall pointe readiness were evaluated using descriptive statistics, kappa, diagnostic metrics, and logistic regression. Setting: Private practice office; ballet studios. Results: There was 94% agreement among raters in determining overall pointe readiness, and individual tests all had significant interrater agreement ranging from 62% to 97% (P ≤ .04). Ankle plantarflexion >90° (100%), stability in grand plié (100%), and holding relevé (96%) had the highest sensitivity for overall readiness, indicating their necessity to advance to pointe. The tests with greatest specificity for identifying lack of readiness were relevé passé (72%), sauté (72%), and airplane (69%). Conclusions: This study provides preliminary testing of a reliable screening tool, the PASSÉ screen, which can be utilized to determine pointe readiness with excellent interrater agreement for the overall pass/fail and significant agreement for tests that contribute to readiness. At minimum, dancers must be able to pass the grand plié, ankle plantar flexion, and relevé tests. Also passing the sauté, relevé passé, and airplane tests indicates high likelihood of readiness.

PMID:39723557 | DOI:10.1177/1089313X241307736

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Nevin Manimala Statistics

Quality evolution of laparoscopic cholecystectomy videos over two decades: a comparative study of YouTube and WebSurg

ANZ J Surg. 2024 Dec 26. doi: 10.1111/ans.19359. Online ahead of print.

ABSTRACT

BACKGROUND: Laparoscopic cholecystectomy is one of the most commonly performed surgeries worldwide. With the rise of online platforms like YouTube and WebSurg, surgical videos have become popular educational tools. However, the quality of these videos varies, raising concerns about their reliability. This study evaluates the changes in the quality of laparoscopic cholecystectomy videos over two decades and compares the educational value of YouTube and WebSurg videos.

METHODS: Twenty-four videos were analyzed and divided into four groups: older YouTube, older WebSurg, newer YouTube, and newer WebSurg. Six videos from each group were selected based on relevance and popularity. Three independent surgeons assessed them using standardized scoring systems, including the JAMA Benchmark Score, Global Quality Score (GQS), LAP-VEGaS, and a new Laparoscopic Cholecystectomy-Specific Score (LAP Chole-SS). Video characteristics such as duration, uploader type, and viewer engagement were also considered. Statistical comparisons were made between the groups.

RESULTS: The analysis showed that although newer videos were longer, the difference was not statistically significant (P = 0.74). Newer videos had significantly better image quality (P < 0.001). WebSurg videos consistently outperformed YouTube videos across all evaluation criteria. WebSurg scored higher in the JAMA Benchmark (2.62 versus 1.66), GQS (3.58 versus 2.63), LAP-VEGaS (13.7 versus 6.58), and LAP Chole-SS (4.08 versus 2.33).

CONCLUSION: In conclusion, WebSurg provides higher-quality, peer-reviewed content, making it more reliable for surgical education, while YouTube offers accessibility but often lacks educational rigor.

PMID:39723551 | DOI:10.1111/ans.19359

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Nevin Manimala Statistics

Clinicopathologic Characteristics of Breast Cancer Patients Who Had a Pathologic Complete Response after Neoadjuvant Treatment

Ann Ital Chir. 2024;95(6):1240-1248. doi: 10.62713/aic.3403.

ABSTRACT

AIM: Breast cancer is the most common cancer in women and is a leading cause of cancer-related mortality. The role of neoadjuvant therapy (NAT) in conjunction with surgical intervention is becoming increasingly prominent in the field of oncology. NAT enhance the probability of breast-conserving surgery in cases of locally advanced breast cancer and in patients with metastatic or inoperable disease.

METHODS: The study included patients who underwent surgery following neoadjuvant chemotherapy for breast cancer between 2012 and 2022. Their files were retrospectively analyzed. The following parameters were examined and statistically analyzed for patients with and without pathological complete response: age, gender, tumor size, location, stage, pathological type, grade, hormone receptor status, molecular type, and the type of surgery performed.

RESULTS: The study cohort comprised 329 patients who received NAT for breast cancer. Of the patients included in the study, 243 underwent mastectomy and 86 underwent breast-conserving surgery. A postoperative histopathologic examination revealed pathologic complete response (pCR) in 89 patients. The results of the statistical analysis indicated that certain parameters, including high grade, negative hormone receptor status, human epidermal growth factor receptor 2 (HER2) positivity, Ki-67 ≥30, and early tumor stage, were associated with higher rates of pCR following NAT.

CONCLUSIONS: The biomarkers identified in this study, including hormone receptor negativity, anatomical Tumour, Node, Metastasis (TNM) Stages 1-2 tumors, positive HER2 amplification, Ki-67 proliferation ≥30%, luminal B/HER2 (+) and HER2 (+) molecular subtypes, are crucial in predicting the likelihood of a complete response to NAT in breast cancer. The presence of these clinicopathologic biomarkers facilitates the process of therapeutic decision-making by identifying patients who are likely to achieve a complete response.

PMID:39723525 | DOI:10.62713/aic.3403

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Nevin Manimala Statistics

Tips and Tricks to Facilitate Late Open Surgical Conversion after Endovascular Aortic Aneurysms Repair

Ann Ital Chir. 2024;95(6):1076-1084. doi: 10.62713/aic.3487.

ABSTRACT

Endovascular repair has significantly improved the treatment of aortic aneurysms, particularly in older and high-risk patients. However, many studies have not found significant differences in long-term outcomes when comparing open and endovascular repair methods. Additionally, endovascular repair is associated with a higher rate of aortic-related reinterventions compared to open repair (OR), sometimes necessitating late open surgical conversion (LOSC). The increasing number of endovascular aortic aneurysm repairs exposes vascular surgeons to a growing number of patients requiring late open surgical conversion (LOSC) after previous endovascular aneurysm repair (EVAR) or thoracic endovascular aortic repair (TEVAR). LOSC following endovascular procedures is associated with higher perioperative mortality and complication rates compared to primary open repair of aortic aneurysms. This review summarizes the current knowledge, indications, possibilities, and techniques for LOSC after initial endovascular procedures. While the incidence of complications requiring LOSC remains relatively low, the number of endovascular procedures performed has increased significantly over the last decade, suggesting a rise in LOSC procedures as well. Due to the complexity involved, LOSC procedures should be performed in high-volume centers by highly experienced vascular surgeons. This underlines the importance of educating the younger generation of vascular surgeons in both endovascular and open aortic surgery.

PMID:39723523 | DOI:10.62713/aic.3487

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Nevin Manimala Statistics

Systematic Review and Meta-Analysis of Application of Ultrasound-Guided Thoracic Paravertebral Block in Clinical Surgical Treatment

Ann Ital Chir. 2024;95(6):1026-1047. doi: 10.62713/aic.3495.

ABSTRACT

AIM: There is a lack of consensus regarding the efficacy of thoracic paravertebral block (TPVB) and erector spinae plane block (ESPB) for postoperative pain in randomized controlled trials (RCTs). The comparison of TPVB and ESPB was explored through a systematic review and meta-analysis (MA) of relevant RCTs.

METHODS: A comprehensive search of relevant literature was conducted using databases such as PubMed, Embase, and MEDLINE, from 2019 to June 2024. The search utilized keywords such as “TPVB”, “ESPB”, and “postoperative analogy”. Following the search, quality evaluation and extraction of outcome indicators were implemented. The software RevMan5.3 was employed for data analysis and evaluation.

RESULTS: The analysis included 18 articles. In patients at rest, a significant difference in pain scores was observed between the TPVB group and the ESPB group at 1 h postoperatively, with a standardized mean difference (SMD) of -0.52 [95% confidence interval (CI): -0.88 to -0.16, p = 0.005]. In non-resting patients, there were significant differences in pain scores between TPVB and ESPB at 24 and 48 h postoperatively. At 24 h postoperatively, the SMD was -0.37 (95% CI: -0.69 to -0.05, p = 0.02), and at 48 h postoperatively, in the visual analog scale (VAS) subgroup, the SMD was -0.38 (95% CI: -0.65 to -0.11, p = 0.006). Furthermore, notable statistical variations were identified in the frequency of rescue analgesia required following surgery between TPVB and ESPB.

CONCLUSIONS: The meta-analysis indicated that lower clinical pain scores in non-resting states at 24 and 48 h post-surgery were associated with TPVB rather than ESPB. This finding was accompanied by a more discernible and accurate analgesic effect, as well as a significant reduction in the need for rescue analgesia following surgical procedures.

PMID:39723521 | DOI:10.62713/aic.3495

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Nevin Manimala Statistics

Comparison of the Efficacy and Safety of Thyroid Microwave Ablation and Radiofrequency Ablation versus Open Surgery for the Treatment of Benign Thyroid Nodules: A Propensity Score Matching Study

Ann Ital Chir. 2024;95(6):1108-1117. doi: 10.62713/aic.3531.

ABSTRACT

AIM: With the advantage of preserving thyroid function while minimizing intervention-related morbidity, minimally invasive thermal ablation techniques such as microwave ablation (MWA) and radiofrequency ablation (RFA) have emerged as alternatives to traditional open surgery. This study compares the efficacy and safety of MWA and RFA with that of open surgery for the treatment of benign thyroid nodules by utilizing a propensity score matching study design to improve comparability.

METHODS: This retrospective study included patients with benign thyroid nodules treated at the North China Electric Power University (Baoding) School Hospital between May 2020 and May 2023. Following propensity score matching, the patients were equally divided into three treatment groups: MWA, RFA, and open surgery. Data on demographic characteristics, thyroid function, treatment outcomes (including nodule size reduction, postoperative pain, cosmetics, hospital stay, and quality of life (QoL)), and postoperative complications were analyzed.

RESULTS: A total of 160 patients, including 55 patients who received MWA, 58 patients treated with RFA and 47 patients operated with open surgery, were initially included. Propensity score matching, aimed at minimizing baseline differences among the groups, was conducted, leaving behind 105 patients, who were equally distributed with 35 persons per group. Compared to open surgery, both MWA and RFA significantly reduced intraoperative blood loss, operation time, length of hospital stay, and pain scores (p < 0.05). The incidence of complications, such as hypothyroidism, hematoma, wound pain, and incision adhesion, was also significantly lower (p < 0.05). In addition, the MWA and RFA were superior to open surgery in terms of cosmetic satisfaction and overall QoL scores (p < 0.05). No significant differences were observed between the MWA and RFA groups in terms of treatment efficacy, complication rates, cosmetic satisfaction, and QoL scores (p > 0.05). At the 6-month follow-up, no significant differences in thyroid function were observed among the three treatment modalities (p > 0.05).

CONCLUSIONS: MWA and RFA exhibit comparable outcomes, in terms of efficacy and safety, for the treatment of benign thyroid nodules, with advantages over open surgery including shorter hospital stays, lower level of postoperative pain, better cosmetic outcomes, higher QoL scores, and lower rates of certain complications.

PMID:39723518 | DOI:10.62713/aic.3531

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Nevin Manimala Statistics

Jaw Growth and Development in Class II Division I Malocclusion Children Using the Myobrace® Muscle Function Appliance

Ann Ital Chir. 2024;95(6):1270-1279. doi: 10.62713/aic.3555.

ABSTRACT

AIM: Class II Division I malocclusion is common in pediatric orthodontics, and is often associated with malocclusion and poor muscle functionality. However, research on post-treatment changes in maxillomandibular dimensions, excluding normal development influences, is limited. Therefore, this study aimed to investigate the effects of Myobrace® appliance and targeted muscle functional training on maxillomandibular dimensions in children with Class II Division I malocclusion, compared to directed oral muscle training alone.

METHODS: This retrospective study included 96 children with Class II Division I malocclusion. Based on the treatment method, the patients were divided into two groups: the treatment group (patients who underwent treatment with the Myobrace® muscle function appliance combined with directed muscle functional training for one year) and the control group (patients who received only directive oral muscle training for one year). The growth changes in jaws in both groups were assessed through X-ray cephalometry and plaster casting.

RESULTS: The Sella-Nasion to A point angle (SNA) had increased (p > 0.05), and the maxilla length increased, with significant differences between the two groups (p < 0.05). Furthermore, after intervention, there was a significant increase in mandibular length (p < 0.05). There was a slight decrease in the S-Co value indicating the position of the mandibula. However, this change was not significant, indicating that the mandibula didn’t move forward after treatment. The angle between the Frankfort Horizontal Plane and mandibular planes (MP-FH) increased after treatment (p > 0.05), and there were increasing trends on the Y axis, posterior heights, and anterior heights, and these changes were statistically significant (p < 0.05). Additionally, we observed a significant increase in the dental arch (p < 0.05) in the treatment group compared to the control group. This finding suggested that the Myobrace® appliance can promote dental arch growth.

CONCLUSIONS: Myobrace® appliance effectively boosts dental arch growth while correcting Class II Division I malocclusion. However, it may be limited in cases of Class II Division I with high-angle, maxillary protrusion, or severe mandibular retrusion, emphasizing the significance of assessing patient characteristics to ensure optimal improvement.

PMID:39723517 | DOI:10.62713/aic.3555