Category: Statistics

JAMA Netw Open. 2023 Aug 1;6(8):e2327145. doi: 10.1001/jamanetworkopen.2023.27145.

ABSTRACT

IMPORTANCE: Anti-programmable cell death-1 (anti-PD-1) improves relapse-free survival when used as adjuvant therapy for high-risk resected melanoma. However, it can lead to immune-related adverse events (irAEs), which become chronic in approximately 40% of patients with high-risk melanoma treated with adjuvant anti-PD-1.

OBJECTIVE: To determine the incidence, characteristics, and long-term outcomes of chronic irAEs from adjuvant anti-PD-1 therapy.

DESIGN, SETTING, AND PARTICIPANTS: This retrospective multicenter cohort study analyzed patients treated with adjuvant anti-PD-1 therapy for advanced and metastatic melanoma between 2015 and 2022 from 6 institutions in the US and Australia with at least 18 months of evaluable follow-up after treatment cessation (range, 18.2 to 70.4 months).

MAIN OUTCOMES AND MEASURES: Incidence, spectrum, and ultimate resolution vs persistence of chronic irAEs (defined as those persisting at least 3 months after therapy cessation). Descriptive statistics were used to analyze categorical and continuous variables. Kaplan-Meier curves assessed survival, and Wilson score intervals were used to calculate CIs for proportions.

RESULTS: Among 318 patients, 190 (59.7%) were male (median [IQR] age, 61 [52.3-72.0] years), 270 (84.9%) had a cutaneous primary, and 237 (74.5%) were stage IIIB or IIIC at presentation. Additionally, 226 patients (63.7%) developed acute irAEs arising during treatment, including 44 (13.8%) with grade 3 to 5 irAEs. Chronic irAEs, persisting at least 3 months after therapy cessation, developed in 147 patients (46.2%; 95% CI, 0.41-0.52), of which 74 (50.3%) were grade 2 or more, 6 (4.1%) were grade 3 to 5, and 100 (68.0%) were symptomatic. With long-term follow-up (median [IQR], 1057 [915-1321] days), 54 patients (36.7%) experienced resolution of chronic irAEs (median [IQR] time to resolution of 19.7 [14.4-31.5] months from anti-PD-1 start and 11.2 [8.1-20.7] months from anti-PD-1 cessation). Among patients with persistent irAEs present at last follow-up (93 [29.2%] of original cohort; 95% CI, 0.25-0.34); 55 (59.1%) were grade 2 or more; 41 (44.1%) were symptomatic; 24 (25.8%) were using therapeutic systemic steroids (16 [67%] of whom were on replacement steroids for hypophysitis (8 [50.0%]) and adrenal insufficiency (8 [50.0%]), and 42 (45.2%) were using other management. Among the 54 patients, the most common persistent chronic irAEs were hypothyroid (38 [70.4%]), arthritis (18 [33.3%]), dermatitis (9 [16.7%]), and adrenal insufficiency (8 [14.8%]). Furthermore, 54 [17.0%] patients experienced persistent endocrinopathies, 48 (15.1%) experienced nonendocrinopathies, and 9 (2.8%) experienced both. Of 37 patients with chronic irAEs who received additional immunotherapy, 25 (67.6%) experienced no effect on chronic irAEs whereas 12 (32.4%) experienced a flare in their chronic toxicity. Twenty patients (54.1%) experienced a distinct irAE.

CONCLUSIONS AND RELEVANCE: In this cohort study of 318 patients who received adjuvant anti-PD-1, chronic irAEs were common, affected diverse organ systems, and often persisted with long-term follow-up requiring steroids and additional management. These findings highlight the likelihood of persistent toxic effects when considering adjuvant therapies and need for long-term monitoring and management.

PMID:37535354 | DOI:10.1001/jamanetworkopen.2023.27145

JAMA Netw Open. 2023 Aug 1;6(8):e2327272. doi: 10.1001/jamanetworkopen.2023.27272.

ABSTRACT

IMPORTANCE: Deviations from international resuscitation guidelines during the management of pediatric cardiac arrest are frequent and affect clinical outcomes. An interactive tablet application (app), PediAppRREST, was developed to reduce guideline deviations during pediatric cardiac arrest.

OBJECTIVE: To assess the effectiveness of PediAppRREST in improving the management of simulated in-hospital pediatric cardiac arrest.

DESIGN, SETTING, AND PARTICIPANTS: This multicenter 3-group simulation-based randomized clinical trial was conducted from September 2020 to December 2021 at 4 Italian university hospitals (Padua, Florence, Rome, Novara). Participants included residents in pediatrics, emergency medicine, and anesthesiology. Analyses were conducted as intention-to-treat. Data were analyzed from January to June 2022.

INTERVENTIONS: Teams were randomized to 1 of 3 study groups: an intervention group that used the PediAppRREST app; a control group that used a paper-based cognitive aid, the Pediatric Advanced Life Support (PALS) pocket card; and a control group that used no cognitive aids. All the teams managed the same standardized simulated scenario of nonshockable pediatric cardiac arrest.

MAIN OUTCOMES AND MEASURES: The primary outcome was the number of deviations from guidelines, measured by a 15-item checklist based on guideline recommendations. The main secondary outcomes were quality of chest compressions, team clinical performance (measured by the Clinical Performance Tool), and perceived team leader’s workload. Study outcomes were assessed via video reviews of the scenarios.

RESULTS: Overall 100 teams of 300 participants (mean [SD] age, 29.0 [2.2] years; 195 [65%] female) were analyzed by intention-to-treat, including 32 teams randomized to the PediAppRREST group, 35 teams randomized to the PALS control group, and 33 teams randomized to the null control group. Participant characteristics (210 pediatric residents [70%]; 48 anesthesiology residents [16%]; 42 emergency medicine residents [14%]) were not statistically different among the study groups. The number of deviations from guidelines was significantly lower in the PediAppRREST group than in the control groups (mean difference vs PALS control, -3.0; 95% CI, -4.0 to -1.9; P < .001; mean difference vs null control, -2.6; 95% CI, -3.6 to -1.5; P < .001). Clinical Performance Tool scores were significantly higher in the PediAppRREST group than control groups (mean difference vs PALS control, 1.4; 95% CI, 0.4 to 2.3; P = .002; mean difference vs null control, 1.1; 95% CI, 0.2 to 2.1; P = .01). The other secondary outcomes did not significantly differ among the study groups.

CONCLUSIONS AND RELEVANCE: In this randomized clinical trial, the use of the PediAppRREST app resulted in fewer deviations from guidelines and a better team clinical performance during the management of pediatric cardiac arrest.

TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT04619498.

PMID:37535352 | DOI:10.1001/jamanetworkopen.2023.27272

J Sports Med Phys Fitness. 2023 Aug 3. doi: 10.23736/S0022-4707.23.15056-0. Online ahead of print.

ABSTRACT

BACKGROUND: Poor information is available regarding real field data on the different factors that could have an influence on curve sprint and its association with anthropometric and strength parameters.

METHODS: We designed a crossover pilot-study that enrolled 14 track and field athletes of 200 and 400 m (8/14 men, age: 20.5±2.3 years, height: 1.73±0.06 m; body mass: 60.5±6.2 kg) that performed randomly in two different days assessment of anthropometric parameters, jump test by squat jump (SJ) and triple hop distance (THD), performance during a 20-m curve sprint (day 1), and assessment of 1RM for right and left limb on Bulgarian split squat (BSS) (day 2). The unpaired t test and Pearson’s correlation were used for data analysis.

RESULTS: No statistical differences for anthropometric and strength parametric parameters between right and left lower limbs were observed. Twenty-meter curve sprints were negatively associated with body mass (P=0.0059, R=-0.7) and Body Mass Index (BMI; P=0.032, R=0.6). Moreover, a negative association was observed with SJ height (P=0.0025, R=-0.7), speed (P=0.0028; R=-0.7), strength (P=0.009, R=-0.7) and power (P=0.009, R=-0.7). Finally, 20-m curve sprint negatively correlated with right (P=0.0021, R=-0.7) and left (P<0.0001, R=-0.9) THD and 1 RM right (P=0.025, R=-0.6;) and left (P=0.0049, R=-0.7) BSS, respectively.

CONCLUSIONS: This pilot study demonstrated that 20-m curve sprint was negatively associated with body mass, BMI, vertical jump performance, THD and 1RM BSS. This information could be useful to coaches and sport scientists as a reference value to improve athlete performance for 200- and 400-m athletes.

PMID:37535342 | DOI:10.23736/S0022-4707.23.15056-0

Med Sci Sports Exerc. 2023 Aug 2. doi: 10.1249/MSS.0000000000003271. Online ahead of print.

ABSTRACT

PURPOSE: To compare the effects of free-weight and machine-based resistance training on strength, hypertrophy, and joint discomfort.

METHODS: Thirty-eight resistance-trained men participated in an 8-week resistance program allocated into free-weight (n = 19) or machine-based (n = 19) groups. Training variables were identical for both modalities, so they only differed in the use of barbells or machines to execute the full squat, bench press, prone bench pull, and shoulder press exercises. The velocity-based method was implemented to accurately adjust the intensity throughout the program. Strength changes were evaluated using 8 velocity-monitored loading tests (4 exercises x 2 modalities) and included the relative one-repetition maximum (1RMRel), as well as the mean propulsive velocity against low (MPVLow) and high (MPVHigh) loads. Ultrasound-derived cross-sectional area (CSA) of quadriceps (proximal and distal regions), pectoralis major, and rectus abdominis was measured to examine hypertrophy. Complementarily, WOMAC and DASH questionnaires were administrated to assess changes in lower- and upper-limb joint discomfort. Outcomes were compared using ANCOVA and percentage of change (∆) statistics.

RESULTS: Each group significantly (p < 0.001) increased 1RMRel, MPVLow, and MPVHigh for both modalities tested, but especially in the one they trained. When considering together the 8 exercises tested, strength changes for both modalities were similar (∆ differences ≤1.8%, p ≥ 0.216). Likewise, the CSA of all the muscles evaluated was significantly increased by both modalities, with no significant differences between them (∆ difference ≤ 2.0%, p ≥ 0.208). No between-group differences (p ≥ 0.144) were found for changes in stiffness, pain, and functional disability levels, which were reduced by both modalities.

CONCLUSIONS: Free-weight and machine-based modalities are similarly effective to promote strength and hypertrophy without increasing joint discomfort.

PMID:37535335 | DOI:10.1249/MSS.0000000000003271

Med Sci Sports Exerc. 2023 Jul 28. doi: 10.1249/MSS.0000000000003260. Online ahead of print.

ABSTRACT

INTRODUCTION: Objectively measured physical activity (PA) data were collected in the accelerometry sub-study of the UK Biobank. UK Biobank also contains information about MS diagnosis at the time of and after PA collection. This study aims to: 1) Quantify the difference in PA between prevalent MS cases and matched healthy controls; 2) Evaluate the predictive performance of objective PA measures for incident MS cases.

METHODS: The first analysis compared eight accelerometer-derived PA summaries between MS patients (N = 316) and matched controls (30 controls for each MS case). The second analysis focused on predicting time to MS diagnosis among participants who were not diagnosed with MS. A total of 19 predictors including eight measures of objective PA were compared using Cox proportional hazards models (number of events = 47; 585,900 person-years of follow-up).

RESULTS: In the prevalent MS study, the difference between MS cases and matched controls was statistically significant for all PA summaries (p < 0.001). In the incident MS study, the most predictive variable of progression to MS in univariate Cox regression models was lower age (C = 0.604) and the most predictive PA variable was lower relative amplitude (RA, C = 0.594). A two-stage forward selection using Cox regression resulted in a model with concordance C = 0.693 and four predictors: age (p = 0.015), stroke (p = 0.009), Townsend deprivation index (p = 0.874), and RA (p = 0.004). A model including age, stroke, and RA had a concordance of C = 0.691.

CONCLUSIONS: Objective PA summaries were significantly different and consistent with lower activity among study participants who had MS at the time of the accelerometry study. Among individuals who did not have MS, younger age, stroke history, and lower RA were significantly associated with higher risk of a future MS diagnosis.

PMID:37535318 | DOI:10.1249/MSS.0000000000003260

Aging Clin Exp Res. 2023 Aug 3. doi: 10.1007/s40520-023-02516-6. Online ahead of print.

ABSTRACT

BACKGROUND: Recently developed absolute and body size normalized handgrip strength (HGS) cut-points could be used individually and collectively to predict mobility problems and falls.

AIMS: We examined the associations of (1) each absolute and normalized weakness cut-point, (2) collective weakness categories, and (3) changes in weakness status on future falls in older Americans.

METHODS: The analytic sample included 11,675 participants from the 2006-2018 waves of the Health and Retirement Study. Falls were self-reported. Men were classified as weak if their HGS was < 35.5-kg (absolute), < 0.45 kg/kg (body mass normalized), or < 1.05 kg/kg/m² (body mass index normalized). While, women were considered weak if their HGS was < 20.0-kg, < 0.337 kg/kg, or < 0.79 kg/kg/m². Collective weakness categorized those below 1, 2, or all 3 cut-points. The collective weakness categories were also used to observe changes in weakness status over time.

RESULTS: Older Americans below each absolute and normalized cut-point had greater odds for future falls: 1.23 (95% confidence interval (CI): 1.15-1.32) for absolute weakness, 1.20 (CI 1.11-1.29) for body mass index normalized weakness, and 1.26 (CI 1.17-1.34) for body mass normalized weakness. Persons below 1, 2, or all 3 weakness cut-points had 1.17 (CI 1.07-1.27), 1.29 (CI 1.18-1.40), and 1.36 (CI 1.24-1.48) greater odds for future falls, respectively. Those in some changing weakness categories had greater odds for future falls: 1.26 (CI 1.08-1.48) for persistent and 1.31 (CI 1.11-1.55) for progressive.

DISCUSSION: Collectively using these weakness cut-points may improve their predictive value.

CONCLUSION: We recommend HGS be evaluated in mobility and fall risk assessments.

PMID:37535311 | DOI:10.1007/s40520-023-02516-6

Med Biol Eng Comput. 2023 Aug 3. doi: 10.1007/s11517-023-02894-z. Online ahead of print.

ABSTRACT

Humeral motion can be challenging to measure and analyze. Typically, Euler/Cardan sequences are used for humeral angle decomposition, but choice of rotation sequence has substantial effects on outcomes. A new method called True axial rotation calculation may be more precise. The objective of this study is to compare humeral axial rotation measured from two systems (optical motion capture and inertial measurement units (IMUs)) and calculated with two methods (Euler angles and True axial). Motion of torso and dominant humerus of thirty participants free from any upper limb impairments was tracked using both systems. Each participant performed a functional tasks protocol. Humeral axial rotation was calculated with Euler decomposition and the True axial method. Waveforms were compared with two-way ANOVA statistical parametric mapping. A consistent pattern emerged: axial rotation was not different between motion capture systems when using the True axial method (p > .05), but motion capture systems showed relatively large magnitude differences (~ 20-30°) when using Euler angle calculation. Between-calculation method differences were large for both motion capture systems. Findings suggest that the True axial rotation method may result in more consistent findings that will allow for precise measurements and comparison between motion capture systems. Two methods for calculating humeral axial rotation measured from optical motion capture and inertial measurement units were compared.

PMID:37535299 | DOI:10.1007/s11517-023-02894-z

Environ Sci Pollut Res Int. 2023 Aug 3. doi: 10.1007/s11356-023-29090-8. Online ahead of print.

ABSTRACT

This study investigated the impact of efficiency, reliability, responsiveness, safety, and security on customer satisfaction with sustainable e-banking. The study used a quantitative methodology, with data collected from customers of commercial banks in South Punjab, Pakistan. A Likert scale questionnaire was used to collect cross-sectional data. A sample of 350 was analyzed using the Statistical Package for the Social Sciences (SPSS) for testing descriptive statistics, correlation analysis, and regression results. The study’s results revealed that efficiency, reliability, responsiveness, safety, and security significantly impacted customer satisfaction with e-banking services. Efficiency and reliability were the most crucial factors influencing customer satisfaction, followed by safety, security, and responsiveness. The research findings have important implications for commercial banks, as they highlight the critical role of these factors in the development of sustainable e-banking practices. Overall, the study provides valuable insights for commercial banks seeking to improve their e-banking services and ensure customer satisfaction. Commercial banks can enhance their competitiveness and achieve sustainable growth in the highly competitive e-banking sector by prioritizing efficiency, reliability, responsiveness, and safety and security.

PMID:37535282 | DOI:10.1007/s11356-023-29090-8

Ann Surg Oncol. 2023 Aug 3. doi: 10.1245/s10434-023-14033-x. Online ahead of print.

ABSTRACT

BACKGROUND: This study aimed to compare the efficacy and postoperative quality of life for patients with esophageal cancer treated by either the modified or the traditional thoracolaparoscopic McKeown procedure.

METHODS: This retrospective case-control study included 269 patients with esophageal cancer admitted to three medical centers in China from February 2020 to August 2022. The patients were divided according to surgical method into the layered hand-sewn end-to-end invagination anastomosis group (modified group) and the traditional hand anastomosis group (traditional group). Propensity score-matching (PSM) was used to maintain balance and comparability between the two groups.

RESULTS: The differences in age and tumor location between the patients in the traditional and modified groups were statistically significant. After PSM, the aforementioned factors were statistically insignificant. After PSM, each group had 101 patients. The modified group showed the greater advantage in terms of postoperative hospital stay (P = 0.036), incidence of anastomotic leak (P = 0.009), and incidence of gastroesophageal reflux (P < 0.001), and the difference was statistically significant. The results of the Quality of Life Questionnaire Core 30 (QLQ-C30) and Quality of Life Questionnaire Oesophageal Cancer Module 18 (QLQ-OES18) scales showed that the modified group also had the advantage over the traditional group in terms of physical function, overall health status, loss of appetite, eating, reflux, obstruction, and loss of appetite scores at the first and third months after surgery.

CONCLUSION: The modified thoraco-laparoscopic McKeown procedure is a safe and effective surgical approach that can significantly reduce the incidence of postoperative anastomotic leak and gastroesophageal reflux, shorten the postoperative hospital stay, and improve the postoperative quality of life for patients with esophageal cancer.

PMID:37535270 | DOI:10.1245/s10434-023-14033-x

Ann Surg Oncol. 2023 Aug 3. doi: 10.1245/s10434-023-13894-6. Online ahead of print.

ABSTRACT

BACKGROUND: The incidence of occult breast cancer among patients undergoing reduction mammoplasty or risk-reducing mastectomies ranges from 1% to approximately 10%, respectively. Identification of incidental cancer often mandates subsequent mastectomy due to ambiguous margins. This study aimed to determine the incidence of contralateral malignancy among patients undergoing oncoplastic breast-conserving surgery (OBCS) with concurrent symmetry procedures.

METHODS: The authors reviewed their prospectively maintained institutional database of patients with unilateral breast cancer who underwent OBCS. Patients who underwent excisional biopsy on the contralateral breast were analyzed separately. Patient demographics, pathologic features, and subsequent disease management were evaluated.

RESULTS: Between March 2018 and July 2022, 289 patients underwent OBCS with a symmetry procedure, and 100 patients yielded contralateral breast tissue specimens. For 14 patients, a planned excisional biopsy was performed with their symmetry procedure, and five lesions (36%) were found to be malignant. Of the remaining 86 patients, 92% underwent preoperative breast magnetic resonance imaging (MRI). Four patients (4.7%) had occult malignancies identified on the contralateral breast pathology; three patients with ductal carcinoma in situ and one patient with invasive lobular carcinoma. Three patients had undergone preoperative MRI without suspicious findings. No patients required mastectomy for treatment of the contralateral breast cancer.

CONCLUSION: The incidence of occult malignancy among OBCS symmetry procedures approaches 5%. The final pathology of excisional biopsies had a higher upgrade rate than previously reported. All identified malignancies were early-stage disease. The higher incidence of occult breast cancer in this population warrants the routine orientation of all specimens, which allows patients with incidental early-stage cancer the option of breast preservation.

PMID:37535266 | DOI:10.1245/s10434-023-13894-6