Category: Statistics

Eur Arch Otorhinolaryngol. 2024 Oct 23. doi: 10.1007/s00405-024-09048-3. Online ahead of print.

ABSTRACT

PURPOSE: This study aims to develop a practical algorithm for utilizing smartphone-based thermal imaging (SBTI) in the perioperative setting and to establish a standardized evaluation method for objectively assessing SBTI images for cutaneous perfusion of pedicled flaps in the face, head, and neck.

METHODS: This prospective conducted study, integrated SBTI into the assessment of 16 patients undergoing reconstructive surgery for face and neck defects. Thermal images were captured at four timepoints: after marking (T1), after flap elevation (T2), upon completion of surgery (T3), and 24 h postoperatively (T4). The flap areas were divided into three flap zones and graded based on temperature differences (ΔT), with a grading system where grade 1 indicated perfect perfusion and grades 2 to 5 indicated increasing perfusion impairment.

RESULTS: 6 male and 10 female patients aged 64-93 years (mean 78.5 years) undergoing reconstructive pedicled skin flap surgery for facial and neck defects (1 × 1 cm to 11 × 8 cm) due to diagnoses of malignant cutaneous lesions were investigated. Intraoperative assessments indicated good perfusion across flaps. One postoperative dehiscence occurred in an 83-year-old male with a cervical advancement flap, correlated with a significant temperature difference (ΔT > 4 °C) intraoperatively. Statistical analysis revealed a strong positive correlation (p = 0.0003) between clinical assessment grades and ΔT values between specific flap zones at T3.

CONCLUSION: SBTI is an easy-to-apply, low-cost, real-time and reproducible technique for indirect perfusion assessment in pedicled skin flaps of the head and neck region. Further studies are needed implementing this methodology in large and free flaps.

PMID:39443388 | DOI:10.1007/s00405-024-09048-3

J Robot Surg. 2024 Oct 24;18(1):375. doi: 10.1007/s11701-024-02136-w.

ABSTRACT

Robotic-assisted surgery has revolutionised minimally invasive approaches, particularly in colorectal surgery. While many single-center studies on colorectal surgeries exist in present literature, including experiences with Senhance® Robotic Systems, comprehensive multi-center studies are lacking. This study, conducted through the TransEnterix European Patient Registry (“TRUST”), aims to assess the safety and feasibility in this context. The present study explored procedural times, complications, robotic malfunction and limitations, adverse events and pain management outcomes for colorectal procedures, including sigmoid resection, right hemicolectomy and rectal surgery collected in two European centers. Data from 355 colorectal surgeries showed that the median duration of surgery was 147.2 min (IQR: 124.3-183.0), the docking time was reported with a median of 3.4 min (IQR: 2.0-5.4) and the console time was found at a mean of 84.4 min (SD: 33.6). Despite minimal blood loss, pain scores, and robotic malfunction, 2.9% of the cases (10 instances) required conversions to either an open or laparoscopic approach. Further, most robotic limitations were attributed to limited motion (18.9%, 67 cases) and collisions (11.5%, 41 cases). Adverse events (24 cases, 6.8%) were effectively managed, with 23 instances judged completely unrelated to the robotic system. This study underscores the positive outcomes and safety profile of Senhance® Robotic Systems in colorectal surgery, contributing valuable insights for future research and clinical practice.

PMID:39443387 | DOI:10.1007/s11701-024-02136-w

Surg Endosc. 2024 Oct 23. doi: 10.1007/s00464-024-11343-3. Online ahead of print.

ABSTRACT

BACKGROUND: Esophageal cancer remains a significant global health challenge. Several treatment modalities were explored in randomized controlled trials (RCTs) in recent decades. This study evaluates the robustness of RCTs focusing on esophageal cancer treatment using the fragility index (FI) and reverse fragility index (RFI).

METHODS: A systematic review of RCTs studying different treatment modalities for esophageal cancer from 2000 to 2023 was conducted. The FI and RFI were utilized to gauge the robustness of statistically significant and non-significant outcomes, respectively. The FI represents the minimal number of patient outcomes that would need to alter to overturn a trial’s statistical significance, while RFI indicates the minimal changes required to achieve significance in non-significant results.

RESULTS: Out of 4028 studies retrieved, 21 RCTs were included for final analysis. The studies spanned 2001 to 2023 with a mean followup of 66 months (range, 29-108 months) and median number of patients of 194 (range, 45-802). The most common treatment modalities examined in these studies were neoadjuvant chemoradiotherapy (n = 7, 33.3%), neoadjuvant chemotherapy (n = 4, 19.0%), and neoadjuvant immunotherapy (n = 2, 9.5%). Only 5 studies (23.8%) had a statistically significant primary outcome result with a median FI of 6 (IQR, 2.5-8.5). Non-significant primary outcomes were seen in 16 studies (76.2%) with a median RFI of 4 (IQR 1-11) and lost to followup of 0 (IQR 0-4). In the study with the highest FI (10), the FI was lower than the number of patients lost to followup (13).

CONCLUSION: Our findings demonstrate that most RCTs on esophageal cancer treatments did not report significant primary outcomes. The few studies that reported significant results had a low fragility index, suggesting a vulnerability in their findings.

PMID:39443379 | DOI:10.1007/s00464-024-11343-3

Surg Endosc. 2024 Oct 23. doi: 10.1007/s00464-024-11337-1. Online ahead of print.

ABSTRACT

BACKGROUND: The COVID-19 pandemic has profoundly impacted the field of surgery, mostly through infectious risks, staff shortages, reduced hospital capacities, and changed patient pathways. Prompted by an increase in wound complications, we performed an in-depth analysis of an example surgical procedure.

METHODS: A consecutive cohort of 195 patients undergoing laparoscopic cholecystectomy was studied retrospectively. Data of patients receiving cholecystectomy before, during, and after the peak of the pandemic were compared. The potential influence of patient characteristics, pandemic phase, and staffing level (surgeons and nurse assistants) was analyzed statistically. In the primary analyses, the composite measure of a ‘textbook outcome’ was examined, which was defined as no relevant complication, hospital stay < 5 days, and no readmission.

RESULTS: During the COVID-19 phase, acute biliary disease was more common than in the pre-COVID-19 phase (62% vs. 30%). In 35% of cases, no qualified operating room nurse was available. Intraoperative features and postoperative complication rates were increased (bile spillage in 46%, wound complications in 24%). A 59-year-old male admitted with acute cholecystitis during COVID-19 died of wound-related septic shock. Multivariate analysis confirmed the acuity of gallbladder inflammation (odds ratio 5.3) and old age (2.6) as risk factors for a non-textbook outcome. The absence of qualified nursing staff was clearly associated with a non-textbook outcome (odds ratio 3.3).

CONCLUSIONS: The fact that laparoscopic cholecystectomy outcomes were worse during COVID-19 can be partly attributed to a change in patient case-mix, but the shortage of qualified nursing staff in the operating room also had a strong negative influence.

PMID:39443378 | DOI:10.1007/s00464-024-11337-1

Surg Endosc. 2024 Oct 23. doi: 10.1007/s00464-024-11350-4. Online ahead of print.

ABSTRACT

OBJECTIVE: To explore the application of small-sized magnetically controlled capsule gastroscopy (MCCG) in upper gastrointestinal diseases screening in asymptomatic individuals.

METHODS: A retrospective analysis of the clinical data of 2163 asymptomatic individuals who underwent small-sized MCCG at our center from September 2022 to December 2023. The detection of submucosal tumors, polyps and ulcers in the upper gastrointestinal tract, the tolerance and safety of the subjects were statistically analyzed.

RESULTS: Suspected submucosal tumors in the upper gastrointestinal tract were detected in 34 (1.57%) of 2136 subjects, with a higher incidence in females and no observed age difference. Polyps were detected in 328 subjects (15.16%), with a higher incidence in females and an increased detection rate with increasing age. Ulcers were detected in 27 subjects (1.25%), with a higher incidence in males and no observed age difference. There was no significant discomfort in all subjects, and no adverse event or capsule retention occurred.

CONCLUSION: Small-sized MCCG can be used for focal lesion screening in the upper gastrointestinal tract and is comfortable and safe, making it a safe and efficient method for examining upper gastrointestinal diseases in the physical examination population.

PMID:39443377 | DOI:10.1007/s00464-024-11350-4

Arch Gynecol Obstet. 2024 Oct 23. doi: 10.1007/s00404-024-07764-z. Online ahead of print.

ABSTRACT

OBJECTIVE: The aim of our study was to assess the impact of sequential embryo transfer on pregnancy outcomes among patients with recurrent implantation failure (RIF).

METHODS: We conducted a comprehensive search across various databases for eligible clinical trials from inception to January 2024. Randomized controlled trials (RCTs) were included if they compared sequential embryo transfer, comprising both cleavage-stage and blastocyst-stage embryos, with other transfer protocols in infertile women with repeated implantation failure. Meta-analysis was performed using Revman software. Our primary focus was on the ongoing pregnancy rate. Our secondary measures included rates of chemical pregnancies, clinical pregnancies, miscarriages, and multiple pregnancies.

RESULTS: Seven RCTs, encompassing 909 patients, met the inclusion criteria. Sequential embryo transfer demonstrated a significant increase in the ongoing pregnancy rate compared to the control group (OR = 2.28, 95% CI [1.46, 3.56], p = 0.003). Moreover, the sequential embryo transfer group exhibited notable improvements in chemical and clinical pregnancy rates. There were no statistically significant differences between the groups regarding multiple pregnancy and miscarriage rates (p > 0.05).

CONCLUSIONS: Sequential embryo transfer shows promise in enhancing pregnancy outcomes among RIF patients. However, additional trials are warranted to validate our findings.

PMID:39443375 | DOI:10.1007/s00404-024-07764-z

Arch Gynecol Obstet. 2024 Oct 23. doi: 10.1007/s00404-024-07792-9. Online ahead of print.

ABSTRACT

PURPOSE: This study aimed to investigate the clinical safety and efficacy of laparoscopic lateral suspension (LLS) with mesh in the treatment of severe anterior and apical pelvic organ prolapse (POP) Chinese women with a 2-year follow-up.

METHODS: We conducted an observational cohort study. Sixty patients who presented apical (uterovaginal or vault) and anterior prolapse at stage 3 or higher were enrolled. The LLS surgical procedure was performed in accordance with Dubuisson standard operation. The objective and subjective cures as well as the surgery-related complications were evaluated. The POP-related questionnaires were used to evaluate the quality of life before operation and at 24 months after operation follow-up.

RESULTS: Objective cure rates at 2 years of follow-up were 88.3% for the anterior compartment, 100% for the apical compartment and 93.3% for the posterior compartment. The subjective cure rate reached to 93.3%. There were statistically significant lower scores of the pelvic floor impact questionnaire-7 (PFIQ-7) and the pelvic floor distress inventory-short form-20 (PFDI-20) for all women after surgery and they exhibited similar scores of the pelvic organ prolapsed-urinary incontinence sexual questionnaire-12 (PISQ-12) (P = 0.317). And no significant difference was demonstrated in international consultation on the incontinent questionnaire short form (ICI-Q-SF) (P = 0.551). No major complications associated with LLS were observed in our study.

CONCLUSION: We consider that LLS with mesh operation is safe, feasible and effective to correct severe apical and anterior POP after 2-year follow-up.

PMID:39443373 | DOI:10.1007/s00404-024-07792-9

AAPS PharmSciTech. 2024 Oct 23;25(8):255. doi: 10.1208/s12249-024-02970-z.

ABSTRACT

The rapid progress in artificial intelligence (AI) has revolutionized problem-solving across various domains. The global challenge of pharmaceutical product recalls imposes the development of effective tools to control and reduce shortage of pharmaceutical products and help avoid such recalls. This study employs AI, specifically machine learning (MI), to analyze critical factors influencing formulation, manufacturing, and formulation complexity which could offer promising avenue for optimizing drug development processes. Utilizing FDAZilla and SafeRX tools, an open database model was constructed, and predictive statistical models were developed using Multivariate Analysis and the Least Absolute Shrinkage and Selection Operator (LASSO) Approach. The study focuses on key descriptors such as delivery route, dosage form, dose, BCS classification, solid-state and physicochemical properties, release type, half-life, and manufacturing complexity. Through statistical analysis, a data simplification process identifies critical descriptors, assigning risk numbers and computing a cumulative risk number to assess product complexity and recall likelihood. Partial Least Square Regression and the LASSO approach established quantitative relationships between key descriptors and cumulative risk numbers. Results have identified key descriptors; BCS Class I, dose number, release profile, and drug half-life influencing product recall risk. The LASSO model further confirms these identified descriptors with 71% accuracy. In conclusion, the study presents a holistic AI and machine learning approach for evaluating and forecasting pharmaceutical product recalls, underscoring the importance of descriptors, formulation complexity, and manufacturing processes in mitigating risks associated with product quality.

PMID:39443361 | DOI:10.1208/s12249-024-02970-z

Clin Oral Investig. 2024 Oct 23;28(11):609. doi: 10.1007/s00784-024-06000-x.

ABSTRACT

OBJECTIVES: Oroantral communication (OAC) is a relatively common and mild complication of maxillary tooth extractions. Preoperative prediction of OAC can reduce treatment duration and prepare both operators and patients for the procedure. This study aims to identify alarming radiographic and clinical indicators that can predict OAC therefore assisting clinical decision making to practicing general dentists.

METHODS: In this retrospective case-control study the OAC group consisting of 97 cases and a control group twice the size was established. Clinical data were collected, and measurements were conducted separately by two blinded observers on digital panoramic radiographs. Inter-rater reliability was assessed. In case of disagreement a third observer’s results were utilized. The correlation between OAC and demographic data (age, sex), as well as various factors assessed on panoramic radiographs (including, but not limited to, the length of the root, root projection into the sinus, bone width, presence of mesial and distal adjacent teeth), was statistically evaluated.

RESULTS: Inter-rater reliability was found to be excellent. Several factors were identified as potential predictors of OAC. According to our model, the strongest predictors were the distance between the cemento-enamel junction and marginal bone, extent of root projection into the sinus, presence of sinus recess around the roots, angulation, and absence of the mesial adjacent tooth.

CONCLUSIONS: Well-defined measurements on panoramic radiographs may aid in predicting OAC. Further prospective investigations are necessary to confirm these indicators and address factors related to clinical examination and operation.

CLINICAL RELEVANCE: We present several clinical and radiographic warning signs of OAC that can facilitate pre-extraction decision-making.

PMID:39443353 | DOI:10.1007/s00784-024-06000-x

Arch Osteoporos. 2024 Oct 23;19(1):102. doi: 10.1007/s11657-024-01458-4.

ABSTRACT

We aimed to investigate the risk of hip fracture associated with zoledronic acid treatment compared to alendronate on a population level. The risk of hip fracture was lower in women using zoledronic acid and higher in women who had discontinued treatment. The findings support the effectiveness of intravenous bisphosphonate.

PURPOSE: To investigate whether zoledronic acid (ZOL) was associated with a lower risk of the first hip fracture than alendronate (ALN) in Norway using real-world data.

METHODS: Nationwide data on drugs dispensed in outpatient pharmacies were individually linked with all hospital-treated hip fractures. Individuals aged 50-89 years without previous hip fracture were included at their first filling of a prescription for ALN or ZOL during 2005-2016. Hazard ratios (HRs) with 95% confidence intervals (95% CIs) for first hip fracture by time-varying exposure to ZOL versus ALN were estimated in sex-stratified flexible parametric survival analyses. Covariates included time-varying accumulated ALN exposure and comorbidity level expressed by the prescription-based Rx-Risk Comorbidity Index, marital status, education, and residential urbanity.

RESULTS: Of 75,250 women who initiated treatment, 72,614 (96.5%) were exposed to ALN and 6366 (8.5%) to ZOL. Of 12,739 men who initiated treatment, 12,311 (96.6%) were exposed to ALN and 784 (6.2%) to ZOL. In women, the HR for first hip fracture was 0.75 (95% CI: 0.61-0.91) for ZOL versus ALN. In men, the corresponding HR was 0.59 (95% CI: 0.32-1.07). Discontinued treatment was associated with increased risk compared with current ALN treatment in women (HR: 1.33; 95% CI: 1.24-1.42, men: HR 1.13 (95% CI: 0.95-1.35)).

CONCLUSIONS: In women, the risk of first hip fracture when treated with ZOL was 25% lower than when treated with ALN. Discontinued treatment was associated with a 33% increase in hip fracture risk. Similar, albeit statistically non-significant, results were observed in men.

PMID:39443347 | DOI:10.1007/s11657-024-01458-4