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Futility in Clinical Trials

JAMA. 2023 Jul 31. doi: 10.1001/jama.2023.14111. Online ahead of print.

NO ABSTRACT

PMID:37523168 | DOI:10.1001/jama.2023.14111

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Uric acid index is a risk for mild cognitive impairment in type 2 diabetes

Hormones (Athens). 2023 Jul 31. doi: 10.1007/s42000-023-00465-3. Online ahead of print.

ABSTRACT

BACKGROUND: A new uric acid (UA) index has recently been proposed, while serum uric acid (SUA), fasting triglyceride, and fasting blood glucose levels in the index are shown to affect cognitive function. This study aims to investigate the clinical value of the UA index for assessing mild cognitive impairment (MCI) in type 2 diabetes (T2D) patients.

METHODS: This was an observational cross-sectional study with 616 participants. A generalized additive model was used to determine a linear or curvilinear relationship between cognitive performance and the UA index. Logistic regression and random forest models were both developed. A receiver operating characteristic curve (ROC) was delineated and the area under the curve (AUC) was calculated.

RESULTS: MCI was diagnosed in 313 participants (50.81%). Compared with the T2D-normal cognitive function group, MCI subjects had higher UA indexes, lower cognitive scores, and lower education levels (p < 0.001). Generalized additive models showed the UA index and the Montreal Cognitive Assessment (MoCA) score to be decreased linearly (p < 0.001). The UA index AUC was 0.751 (95% CI = 0.713-0.789, p < 0.001). The optimal cut-off point for the identification of MCI based on the UA index was 11.26 (sensitivity: 62.3%, specificity: 75.9%). Results for females in the cohort yielded an AUC change of + 2.5%, the less-educated population (AUC change of + 4.7%), and the hypertensive population (AUC change of + 1.1%). The AUCs were 0.791 (95% CI = 0.720-0.863) for the random forest model and 0.804 (95% CI = 0.770-0.837) for the logistic regression model, and no statistical significance was found (p = 0.758).

CONCLUSION: This study showed that the increased UA index was independently associated with MCI in patients with T2D, especially among female, less-educated, and hypertensive patients. It could be a potential indicator of MCI in T2D patients.

PMID:37523135 | DOI:10.1007/s42000-023-00465-3

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An AI-Enabled Dynamic Risk Stratification for Emergency Department Patients with ECG and CXR Integration

J Med Syst. 2023 Jul 31;47(1):81. doi: 10.1007/s10916-023-01980-x.

ABSTRACT

Emergency department (ED) triage scale determines the priority of patient care and foretells the prognosis. However, the information retrieved from the initial assessment is limited, hindering the risk identification accuracy of triage. Therefore, we sought to develop a ‘dynamic’ triage system as secondary screening, using artificial intelligence (AI) techniques to integrate information from initial assessment data and subsequent examinations. This retrospective cohort study included 134,112 ED visits with at least one electrocardiography (ECG) and chest X-ray (CXR) in a medical center from 2012 to 2022. Additionally, an independent community hospital provided 45,614 ED visits as an external validation set. We trained an eXtreme gradient boosting (XGB) model using initial assessment data to predict all-cause mortality in 7 days. Two deep learning models (DLMs) using ECG and CXR were trained to stratify mortality risks. The dynamic triage levels were based on output from the XGB-triage and DLMs from ECG and CXR. During the internal and external validation, the area under the receiver operating characteristic curve (AUC) of the XGB-triage model was >0.866; furthermore, the AUCs of DLMs using ECG and CXR were >0.862 and >0.886, respectively. The dynamic triage scale provided a higher C-index (0.914-0.920 vs. 0.827-0.843) than the original one and demonstrated better predictive ability for 5-year mortality, 30-day ED revisit, and 30-day discharge. The AI-based risk scale provides a more accurate and dynamic stratification of mortality risk in ED patients, particularly in identifying patients who tend to be overlooked due to atypical symptoms.

PMID:37523102 | DOI:10.1007/s10916-023-01980-x

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Do cancer centres and palliative care wards routinely measure patients’ quality of life? An international cross-sectional survey study

Support Care Cancer. 2023 Jul 31;31(8):499. doi: 10.1007/s00520-023-07964-4.

ABSTRACT

PURPOSE: Routinely assessing quality of life (QoL) of patients with cancer is crucial for improving patient-centred cancer care. However, little is known about whether or how cancer centres assess QoL for clinical practice or for research purposes. Therefore, our study aimed to investigate if QoL data is collected and if so, how and for what purposes.

METHOD: We conducted a cross-sectional survey study among 32 cancer centres in Europe and Canada. Centre representatives identified persons who they judged to have sufficient insight into QoL data collections in their wards to complete the survey. Descriptive statistics were used to summarise the information on QoL assessment and documentation.

RESULTS: There were 20 (62.5%) responding cancer centres. In total, 30 questionnaires were completed, of which 13 were completed for cancer wards and 17 for palliative care wards. We found that 23.1% and 38.5% of the cancer wards routinely assessed QoL among inpatients and outpatients with cancer, respectively, whereas, in palliative care wards, 52.9% assessed QoL for outpatients with cancer and 70.6% for the inpatients. Wide variabilities were observed between the cancer centres in how, how often, when and which instruments they used to assess QoL.

CONCLUSION: A sizable proportion of the cancer wards, especially, and palliative care wards apparently does not routinely assess patients’ QoL, and we found wide variabilities between the cancer centres in how they do it. To promote routine assessment of patients’ QoL, we proposed several actions, such as addressing barriers to implementing patient-reported outcome measures through innovative e-health platforms.

PMID:37523097 | DOI:10.1007/s00520-023-07964-4

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Effects of Drop Sets on Skeletal Muscle Hypertrophy: A Systematic Review and Meta-analysis

Sports Med Open. 2023 Jul 31;9(1):66. doi: 10.1186/s40798-023-00620-5.

ABSTRACT

BACKGROUND: One of the most popular time-efficient training methods when training for muscle hypertrophy is drop sets, which is performed by taking sets to concentric muscle failure at a given load, then making a drop by reducing the load and immediately taking the next set to concentric or voluntary muscle failure. The purpose of this systematic review and meta-analysis was to compare the effects of drop sets over traditional sets on skeletal muscle hypertrophy.

METHODS: This systematic review followed the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. The SPORTDiscus and MEDLINE/PubMed databases were searched on April 9, 2022, for all studies investigating the effects of the drop set training method on muscle hypertrophy that meets the predefined inclusion criteria. Comprehensive Meta-Analysis Version 3 (Biostat Inc., Englewood Cliffs, NJ, USA) was used to run the statistical analysis. Publication bias was assessed through visual inspection of the funnel plots for asymmetry and statistically by Egger’s regression test with an alpha level of 0.10.

RESULTS: Six studies met the predefined inclusion criteria. The number of participants in the studies was 142 (28 women and 114 men) with an age range of 19.2-27 years. The average sample size was 23.6 ± 10.9 (range 9-41). Five studies were included in the quantitative synthesis. Meta-analysis showed that both the drop set and traditional training groups increased significantly from pre- to post-test regarding muscle hypertrophy (drop set standardized mean difference: 0.555, 95% CI 0.357-0.921, p < 0.0001; traditional set standardized mean difference: 0.437, 95% CI 0.266-0.608, p < 0.0001). No significant between-group difference was found (standardized mean difference: 0.155, 95% CI – 0.199 to – 0.509, p = 0.392).

CONCLUSIONS: The results of this systematic review and meta-analysis indicate that drop sets present an efficient strategy for maximizing hypertrophy in those with limited time for training. There was no significant difference in hypertrophy measurements between the drop set and traditional training groups, but some of the drop set modalities took half to one-third of the time compared with traditional training.

PMID:37523092 | DOI:10.1186/s40798-023-00620-5

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A Pediatric Upper Airway Library to Evaluate Interpatient Variability of In Silico Aerosol Deposition

AAPS PharmSciTech. 2023 Jul 31;24(6):162. doi: 10.1208/s12249-023-02619-3.

ABSTRACT

The airway of pediatric patients’ changes through development, presenting a challenge in developing pediatric-specific aerosol therapeutics. Our work aims to quantify geometric variations and aerosol deposition patterns during upper airway development in subjects between 3.5 months-6.9 years old using a library of 24 pediatric models and 4 adult models. Computational fluid-particle dynamics was performed with varying particle size (0.1-10 μm) and flow rate (10-120 Lpm), which was rigorously analyzed to compare anatomical metrics (epiglottis angle (θE), glottis to cricoid ring ratio (GC-ratio), and pediatric to adult trachea ratio (H-ratio)), inhaler metrics (particle diameter, [Formula: see text], and flow rate, Q), and clinical metrics (age, sex, height, and weight) against aerosol deposition. Multivariate non-linear regression indicated that all metrics were all significantly influential on resultant deposition, with varying influence of individual parameters. Additionally, principal component analysis was employed, indicating that [Formula: see text], Q, GC-ratio, θE, and sex accounted for 90% of variability between subject-specific deposition. Notably, age was not statistically significant among pediatric subjects but was influential in comparing adult subjects. Inhaler design metrics were hugely influential, thus supporting the critical need for pediatric-specific inhalable approaches. This work not only improves accuracy in prescribing inhalable therapeutics and informing pediatric aerosol optimization, but also provides a framework for future aerosol studies to continue to strive toward optimized and personalized pediatric medicine.

PMID:37523076 | DOI:10.1208/s12249-023-02619-3

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Robotic-assisted technology does not influence functional outcomes among obese and morbidly obese total knee arthroplasty patients

J Exp Orthop. 2023 Jul 31;10(1):76. doi: 10.1186/s40634-023-00634-8.

ABSTRACT

PURPOSE: Despite benefits of total knee arthroplasty (TKA) on function and quality of life, obese patients have less improved functional outcomes following TKA compared to their normal weight counterparts. Furthermore, obesity is a risk factor for aseptic loosening and revision surgery following TKA. With known benefits of robotic-assisted TKA (RaTKA) in precision and patient satisfaction, we aimed to evaluate the differences in patient reported outcome and early complication rates for patients undergoing RaTKA versus conventional TKA among patients of varying BMI groups.

METHODS: This study was a retrospective cohort study of patients who underwent conventional versus RaTKA. Patients were grouped by BMI range (< 30 kg/m2, 30-40 kg/m2, and > 40 kg/m2). Patient-reported outcomes were measured by Oxford Knee Scores and 12-Item Short Form Survey scores preoperatively, 6-month, 1-year, and 2-year postoperatively. Mixed-effects linear models were built for each patient-reported outcome to assess the interaction between type of surgery and BMI while adjusting for known confounders such as demographic variables.

RESULTS: A total of 350 patients (n = 186 RaTKA, n = 164 conventional TKA) met inclusion criteria. SF-12 physical scores were significantly higher at 2-year follow-up among non-obese patients compared to obese and morbidly obese patients (p = 0.047). There was no statistically significant interaction between the type of surgery performed (RaTKA versus conventional TKA) and obesity regarding their effects on patient reported outcomes.

CONCLUSIONS: This study demonstrates no differences in functional outcomes among patients undergoing RaTKA compared to conventional TKA. Furthermore, obesity had no significant effect on this association.

LEVEL OF EVIDENCE: III.

PMID:37523073 | DOI:10.1186/s40634-023-00634-8

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Robotic-assisted vaginal natural orifice transluminal endoscopic surgery versus robotic-assisted single-site port for benign hysterectomy: a comparison of surgical outcomes

J Robot Surg. 2023 Jul 31. doi: 10.1007/s11701-023-01680-1. Online ahead of print.

ABSTRACT

The objective of this study is to evaluate the surgical outcomes for robotic-assisted vaginal natural orifice transluminal endoscopic surgery (R-VNOTES) hysterectomy versus robotic-assisted single-site port (RSSP) hysterectomy when performed for benign indications. This is a retrospective chart review in an academic tertiary setting. 404 patients underwent hysterectomy for benign indications. R-VNOTES hysterectomy and RSSP hysterectomy were performed by a single minimally invasive gynecologic surgeon from January 2015 to August 2022. The primary outcome of our study was total operative time (minutes). Secondary outcomes included estimated blood loss (mL), length of hospital stay (days), and postoperative pain score. Other intraoperative and postoperative surgical complications were also compared. 159 patients underwent R-VNOTES hysterectomy, and 269 patients underwent RSSP hysterectomy. Median length of surgery (minutes) demonstrated a statistically significant shorter operative time in the R-VNOTES hysterectomy group when compared to the RSSP hysterectomy group, (132 min versus 146 min, respectively, p = 0.0001). Additionally, patients in the R-VNOTES hysterectomy group experienced decreased postoperative pain levels at week 1 (6 versus 7, respectively, p = 0.01) and week 3 (1.5 versus 2.5, respectively, p = 0.01) after surgery. There were no statistically significant differences between the two groups when comparing length of hospital stay, estimated blood loss, and weight of the uterus. There was no difference in rates of urinary tract infection, blood transfusion, bowel injury, readmission, reoperation, conversion, deep surgical site infection, and venous thromboembolism between both groups. However, there was a higher rate of superficial SSI in the RSSP hysterectomy group (0.6% versus 4.5%, respectively, p = 0.03). When compared to RSSP hysterectomy, R-VNOTES hysterectomy is safe and feasible, as both approaches have comparable surgical outcomes. Patients undergoing R-VNOTES hysterectomy had shorter length of surgery, decreased postoperative pain, and lower rates of superficial surgical site infections.

PMID:37523047 | DOI:10.1007/s11701-023-01680-1

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Reconstruction of dental roots for implant planning purposes: a retrospective computational and radiographic assessment of single-implant cases

Int J Comput Assist Radiol Surg. 2023 Jul 31. doi: 10.1007/s11548-023-02996-x. Online ahead of print.

ABSTRACT

PURPOSE: The aim of the study was to assess the deviation between clinical implant axes (CIA) determined by a surgeon during preoperative planning and reconstructed tooth axes (RTA) of missing teeth which were automatically computed by a previously introduced anatomical SSM.

METHODS: For this purpose all available planning datasets of single-implant cases of our clinic, which were planned with coDiagnostix Version 9.9 between 2018 and 2021, were collected for retrospective investigation. Informed consent was obtained. First, the intraoral scans of implant patients were annotated and subsequently analyzed using the SSM. The RTA, computed by the SSM, was then projected into the preoperative planning dataset. The amount and direction of spatial deviation between RTA and CIA were then measured.

RESULTS: Thirty-five patients were implemented. The mean distance between the occlusal entry point of anterior and posterior implants and the RTA was 0.99 mm ± 0.78 mm and 1.19 mm ± 0.55, respectively. The mean angular deviation between the CIA of anterior and posterior implants and the RTA was 12.4° ± 3.85° and 5.27° ± 2.97° respectively. The deviations in anterior implant cases were systematic and could be corrected by computing a modified RTA (mRTA) with decreased deviations (0.99 mm ± 0.84 and 4.62° ± 1.95°). The safety distances of implants set along the (m)RTA to neighboring teeth were maintained in 30 of 35 cases.

CONCLUSION: The RTA estimated by the SSM revealed to be a viable implant axis for most of the posterior implant cases. As there are natural differences between the anatomical tooth axis and a desirable implant axis, modifications were necessary to correct the deviations which occurred in anterior implant cases. However, the presented approach is not applicable for clinical use and always requires manual optimization by the planning surgeon.

PMID:37523011 | DOI:10.1007/s11548-023-02996-x

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Variations in sural nerve formation and course in fetuses

Neurosurg Rev. 2023 Jul 31;46(1):189. doi: 10.1007/s10143-023-02098-x.

ABSTRACT

To investigate variations regarding the formation and course of the sural nerve (SN). We dissected 60 formalin-fixed Brazilian fetuses (n = 120 lower limbs) aged from the 16th to 34th weeks of gestational age. Three incisions were made in the leg to expose the SN, and the gastrocnemius muscle was retracted to investigate the SN course. Statistical analyses regarding laterality and sex were performed using the Chi-square test. Eight SN formation patterns were classified after analysis. Type 4 (in which the SN is formed by the union of the MSCN with the LSCN) was the most common SN formation pattern. Although there was no statistical association between the formation patterns and the lower limb laterality (p = 0.9725), there was as to sex (p = 0.03973), indicating an association between anatomical variation and sex. The site of branch joining was in the distal leg most time (53.75%). In all lower limbs, the SN or its branches crossed from the medial aspect of the leg to the lateral margin of the calcaneal tendon (CT). Most often, the SN is formed by joining the MSCN and the LSCN in the distal leg. The SN or its branches ran close to the saphenous vein, crossed the CT from medial to lateral, and distributed around the lateral malleolus.

PMID:37522997 | DOI:10.1007/s10143-023-02098-x