Tag: statistics

Hernia. 2023 May 28. doi: 10.1007/s10029-023-02803-1. Online ahead of print.

ABSTRACT

PURPOSE: Although there have been numerous studies on single-incision laparoscopic inguinal hernia repair (SIL-IHR), the short- and long-term outcomes in patients from a large single institution who underwent single-incision laparoscopic transabdominal preperitoneal hernioplasty (SIL-TAPP) have rarely been reported. The purpose of this study is to evaluate the short- and long-term outcomes of SIL-TAPP and its safety and feasibility in patients from a large single institution.

METHODS: The details of 1,054 procedures in 966 patients who underwent SIL-TAPP at the Affiliated Hospital of Nantong University from January 2015 to October 2022 were retrospectively analysed. SIL-TAPP was performed completely through the umbilicus using conventional laparoscopic instruments. Short-term and long-term outcomes of SIL-TAPP were collected by outpatient and telephone follow-ups. In addition, we further compared the operation time, length of postoperative hospital stay, and postoperative complications of patients with simple and complicated unilateral inguinal hernias.

RESULTS: A total of 1,054 procedures were performed for 878 unilateral inguinal hernias and 88 bilateral inguinal hernias. In total, there were 803 (76.2%) indirect inguinal hernias, 192 (18.2%) direct inguinal hernias, 51 (4.8%) femoral hernias and 8 (0.8%) combined hernias. The mean operative time was 35.5 ± 17.0 min for unilateral inguinal hernias and 51.9 ± 25.5 min for bilateral inguinal hernias. There was one (0.1%) conversion to two-incision laparoscopic transabdominal preperitoneal hernioplasty. No intraoperative haemorrhages, inferior epigastric vessel injury or nerve damage occurred. Postoperative complications were minor and could be resolved without surgical intervention. The mean length of hospital stay was 1.3 ± 0.8 days. The median follow-up was 44 months, no trocar hernia occurred, and there was one (0.1%) recurrence. The operation time in the complicated inguinal hernia group was significantly higher than that in the simple inguinal hernia group (38.9 ± 22.3 vs. 35.0 ± 15.6, p = 0.025). The length of postoperative hospital stay and complication rate of the complicated inguinal hernia group were slightly higher than those of the simple inguinal hernia group, but the difference was not statistically significant.

CONCLUSION: SIL-TAPP is safe and technically feasible, and both short- and long-term outcomes are acceptable.

PMID:37245176 | DOI:10.1007/s10029-023-02803-1

Neurol Ther. 2023 May 28. doi: 10.1007/s40120-023-00494-5. Online ahead of print.

ABSTRACT

INTRODUCTION: This multicentre, randomised, open-label, and prospective study aimed to evaluate the effectiveness of memantine (memantine solution) on speech function in patients with moderate to severe Alzheimer’s disease (AD) who were already on donepezil therapy.

METHODS: Participants were divided into two groups: the drug trial group was administered donepezil + memantine (memantine solution), while the control group was administered only donepezil. Patients in the test group were required to increase the dose of memantine by 5 mg/day per week for the first 4 weeks and were maintained at 20 mg/day until the end of the trial.

RESULTS: Of the 188 participants, 24 dropped out, and 164 completed the final research process. As the primary outcome, K-WAB showed an increase in scores in both groups compared to baseline scores; however, the difference was not statistically significant (P = 0.678). After 12 weeks, the donepezil treatment group had higher K-MMSE and lower CDR-SB scores than the donepezil and memantine combination group, indicating better cognitive and functional status. However, this effect was not sustained for 24 weeks. Patients who were assigned to receive only donepezil had Relevant Outcome Scale for AD (ROSA) scores that were higher by an average of 4.6 points compared to the donepezil and memantine combination group. The NPI-Q index improved compared to baseline values in both groups.

CONCLUSIONS: Although several clinical studies have reported significant improvements in speech function after the administration of memantine, clinical studies on speech function improvement in patients with Alzheimer’s disease are still insignificant. There are no studies on the effect of donepezil and memantine in combination treatment on language function in the moderate and severe stages of AD. Therefore, we investigated the effect of memantine (memantine solution) on speech function in patients with moderate to severe AD who were administered donepezil at a stable dose. Although the efficacy of the combination therapy was not superior to that of donepezil monotherapy alone, memantine was effective in improving behavioural symptoms in patients with moderate or severe AD.

PMID:37245175 | DOI:10.1007/s40120-023-00494-5

J Endocrinol Invest. 2023 May 28. doi: 10.1007/s40618-023-02112-5. Online ahead of print.

ABSTRACT

PURPOSE: Infection with the human immunodeficiency virus (HIV) predisposes to endocrine disorders, manifesting as a metabolic phenotype that affects the entire adipose-musculoskeletal unit (AMS). The present cross-sectional study aimed to investigate differences in irisin and adiponectin concentrations between people living with HIV and healthy controls, as well as to explore potential correlations between the levels of the aforementioned adipokines and markers of calcium homeostasis.

METHODS: 46 HIV-infected individuals and 39 healthy controls (all men) were included in the study. Anthropometric data, adipokine levels, 25-hydroxyvitamin D [(25(OH)D)] and parathyroid hormone (PTH) concentrations were evaluated in the two groups. Correlations for the relationship between adiponectin, irisin, and PTH levels were examined. The results were adjusted for several confounders, including 25(OH)D levels, anthropometry, physical activity, bone mineral density, testosterone levels, and exposure to ultraviolet B radiation.

RESULTS: Mean adiponectin concentrations were significantly lower in the HIV group compared to the control group: 5868 ± 3668 vs 9068 ± 4277 ng/mL, p = 0.011. The same was applicable to irisin concentrations: 8.31 ± 8.17 (HIV) vs 29.27 ± 27.23 (controls) ng/mL, p = 0.013. A statistically significant and negative correlation was observed between irisin and PTH in the control group (r = – 0.591; p = 0.033). In contrast, no significant correlation was observed between PTH and irisin in the HIV group (p = 0.898).

CONCLUSION: Our results are the first to suggest a possible down regulation of the inverse relationship between PTH and irisin in HIV patients and to highlight that AMS dyshomeostasis could be involved in the development of skeletal and adipose HIV-related morbidities.

PMID:37245160 | DOI:10.1007/s40618-023-02112-5

Am J Orthod Dentofacial Orthop. 2023 May 27:S0889-5406(23)00256-1. doi: 10.1016/j.ajodo.2023.05.003. Online ahead of print.

ABSTRACT

INTRODUCTION: This study aimed to analyze the effects of premolar extraction treatment with vertical control on changes in the anatomy and aerodynamics of the oropharynx in Class II hyperdivergent malocclusion with nonsevere crowding.

METHODS: Thirty-nine patients with Class II hyperdivergent malocclusion were enrolled consecutively. All the participants underwent 4 premolar extractions. The high-pull J-hook and mini-implants were used to provide vertical control. Cone-beam computed tomography was performed before and after treatment. The participants were divided into a decreased lower vertical facial height group (n = 23) and an increased lower vertical facial height group (n = 16) on the basis of superimposition. The aerodynamic characteristics, including airway resistance (inspiration, R_in; expiration, R_ex) and maximum velocity (inspiration, Vmax_in; expiration, Vmax_ex) at inspiration and expiration, were calculated using computational fluid dynamics. Anatomic characteristics, including volume and cross-sectional area (CSA_min), were measured using the Dolphin Imaging software (Dolphin Imaging and Management Solutions, Chatsworth, Calif).

RESULTS: After treatment, the median volume and CSA_min increased by 2357 mm³ and 43 mm², respectively, and median R_in and Vmax_ex decreased by 0.15 Pa/L/min and 0.24 m×s^-1, respectively, in decreased lower vertical facial height group. In contrast, the median CSA_min decreased by 9.5 mm² in the increased lower vertical facial height group. All the changes were statistically significant (all P <0.05). Significant differences in volume, CSA_min, R_in, and Vmax_ex were observed between the 2 groups.

CONCLUSIONS: Vertical control might improve the anatomic and aerodynamic characteristics of the oropharyngeal airway during premolar extraction treatment of Class II hyperdivergent malocclusion with nonsevere crowding.

PMID:37245126 | DOI:10.1016/j.ajodo.2023.05.003

Swiss Med Wkly. 2023 May 18;153:40083. doi: 10.57187/smw.2023.40083.

ABSTRACT

BACKGROUND AND AIMS: Chronic musculoskeletal pain is a major public health problem worldwide. Both self-reported functional capacity and self-perceived health status are reduced in patients with chronic musculoskeletal pain. Previous studies mostly assessed functional capacity through self-reported questionnaires instead of objective measurements. The aim of this study, therefore, is to assess the amount of change over time and its clinical meaningfulness in functional capacity and self-perceived health status of patients with chronic musculoskeletal pain undergoing Bern Ambulatory Interprofessional Rehabilitation (BAI-Reha).

METHODS: The registry-based longitudinal cohort study with prospectively collected data from a rehabilitation programme took place in a real-life setting. Patients (n = 81) with chronic musculoskeletal pain took part in the BAI-Reha. The main outcomes were the six-minute-walk test (6MWT), the safe maximum floor-to-waist lift (SML) and the European Quality of Life and Health measure visual analogue scale (EQ VAS). Timepoints of measurement were at baseline and post-BAI-Reha (i.e., at 4 months). The quantity of interest was the adjusted time effect (point estimate, 95% confidence interval, and p-value for testing the null hypothesis of no change over time). Statistical significance (α = 0.05) and clinical meaningfulness of the mean value change over time were assessed using predefined thresholds (six-minute-walk test 50 m, SML 7 kg, and EQ VAS 10 points).

RESULTS: The linear mixed model analysis showed a statistically significant change over time for the six-minute-walk test (mean value change 56.08 m, 95% CI [36.13, 76.03]; p <0.001), SML (mean value change 3.92 kg, 95% CI [2.66, 5.19]; p <0.001), and EQ VAS (mean value change 9.58 points, 95% CI [4.87, 14.28]; p <0.001). Moreover, the improvement in the six-minute-walk test is clinically meaningful (mean value change 56.08 m) and almost clinically meaningful (mean value change 9.58 points) in the EQ VAS.

CONCLUSION: Patients walk further, lift more weight, and feel healthier after interprofessional rehabilitation when compared to baseline measurement. These findings confirm and add to previous results.

IMPLICATIONS: We encourage other providers of rehabilitation for patients with chronic musculoskeletal pain to measure functional capacity with objective outcome variables and to use self-reported outcome measures in addition to self-perceived health status. The well-established assessments used in this study are suitable for this purpose.

PMID:37245120 | DOI:10.57187/smw.2023.40083

Swiss Med Wkly. 2023 May 24;153:40084. doi: 10.57187/smw.2023.40084.

ABSTRACT

BACKGROUND: Optimal throughput times in emergency departments can be adjudicated by emergency physicians. Emergency physicians can also define causes of delays during work-up, such as waiting for imaging, clinical chemistry, consultations, or exit blocks. For adequate streaming, the identification of predictors of delays is important, as the attribution of resources depends on acuity, resources, and expected throughput times.

OBJECTIVE: This observational study aimed to identify the causes, predictors, and outcomes of emergency physician-adjudicated throughput delays.

METHODS: Two prospective emergency department cohorts from January to February 2017 and from March to May 2019 around the clock in a tertiary care centre in Switzerland were investigated. All consenting patients were included. Delay was defined as the subjective adjudication of the responsible emergency physician regarding delay during emergency department work-up. Emergency physicians were interviewed for the occurrence and cause of delays. Baseline demographics, predictor values, and outcomes were recorded. The primary outcome – delay – was presented using descriptive statistics. Univariable and multivariable logistic regression analyses were performed to assess the associations between possible predictors and delays and hospitalization, intensive care, and death with delay.

RESULTS: In 3656 (37.3%) of 9818 patients, delays were adjudicated. The patients with delays were older (59 years, interquartile range [IQR]: 39-76 years vs 49 years, IQR: 33-68 years) and more likely had impaired mobility, nonspecific complaints (weakness or fatigue), and frailty than the patients without delays. The main causes of delays were resident work-up (20.4%), consultations (20.2%), and imaging (19.4%). The predictors of delays were an Emergency Severity Index of 2 or 3 at triage (odds ratio [OR]: 3.00; confidence interval [CI]: 2.21-4.16; OR: 3.25; CI: 2.40-4.48), nonspecific complaints (OR: 1.70; CI: 1.41-2.04), and consultation and imaging (OR: 2.89; CI: 2.62-3.19). The patients with delays had an increased risk for admission (OR: 1.56; CI: 1.41-1.73) but not for mortality than those without delays.

CONCLUSION: At triage, simple predictors such as age, immobility, nonspecific complaints, and frailty may help to identify patients at risk of delay, with the main reasons being resident work-up, imaging, and consultations. This hypothesis-generating observation will allow the design of studies aimed at the identification and elimination of possible throughput obstacles.

PMID:37245118 | DOI:10.57187/smw.2023.40084

Isr Med Assoc J. 2023 May;25(5):328-331.

ABSTRACT

BACKGROUND: Esophageal cancer is comprised of adenocarcinoma and squamous cell carcinoma and is the sixth leading cause of cancer-related mortality worldwide. Upper endoscopy may reveal a partially or completely lumen-occluding mass at diagnosis, yet the prognostic significance of such a presentation is not clear.

OBJECTIVES: To investigate whether endoscopic obstructing lesions have a meaning regarding patient prognosis.

METHODS: We reviewed upper gastrointestinal endoscopic studies performed over a 20-year period (2000-2020). We compared overall survival, disease stage, histologic criteria, and anatomic location of the lesions in esophagus lumen-obstructing and non-obstructing tumors. Differences between the two groups were statistically evaluated.

RESULTS: Sixty-nine patients were diagnosed with histologically confirmed esophageal cancer. As assessed through endoscopy, 32/69 (46%) patients had obstructive and 37/69 (54%) had non-obstructive cancers. Median survival was significantly shorter in the lumen-obstructing lesions compared with the non-obstructing lesions (3.5 months vs. 10 months, P = 0.001). Female median survival displayed a trend toward shorter survival compared to males (3.5 months vs. 10 months, P = 0.059). There was no statistically significant difference in the percentages of advanced, stage IV disease in the obstructive group and the non-obstructive group (11/32 [34.3%] and 14/37 [37.8%], respectively P = 0.80).

CONCLUSIONS: Obstructive esophageal cancers predict shorter median overall survival compared with non-obstructive cancers, without any correlation between obstruction of the lesion and tumor metastatic stage.

PMID:37245096

Isr Med Assoc J. 2023 May;25(5):324-327.

ABSTRACT

BACKGROUND: Cancellation of transesophageal echocardiography (TEE) tests leads to inefficient use of echocardiography laboratory (echo lab) time and wastes resources.

OBJECTIVES: To identify the causes of same-day TEE cancellations in hospitalized patients, to formulate a TEE order screening protocol, and to evaluate its efficacy at implementation.

METHODS: We performed a prospective analysis of inpatients referred to a single tertiary hospital echo lab for TEE study by inpatient wards. A comprehensive screening protocol emphasizing active participation of all links directly involved in the chain of inpatient TEE referral was developed and implemented. Comparison of pre- and post-implementation of the new screening protocol on two consecutive periods of 6 months on TEE cancellation rates out of total ordered TEEs stratified by cause categories was performed.

RESULTS: : In total, 304 inpatient TEE procedures were ordered during the initial observation period; 54(17.8%) were canceled on the same day. The most common cancellation reasons were equally respiratory distress and patient not in fasted state (20.4% of total cancellations and 3.6% of all scheduled TEEs for each cause). Following implementation of the new screening process, total TEEs ordered (192) and cancelled (16) dropped significantly. A decrease in the rate of each cancellation category was observed, with statistical significance achieved for the overall cancellation rate (8.3% vs. 17.8%, P = 0.003), but not for the individual cancellation categories in split analysis.

CONCLUSIONS: A concerted effort to implement a comprehensive screening questionnaire significantly reduced same-day cancellations of scheduled TEEs.

PMID:37245095

Ann Neurol. 2023 May 28. doi: 10.1002/ana.26714. Online ahead of print.

ABSTRACT

Platform trials allow efficient evaluation of multiple interventions for a specific disease. The HEALEY ALS Platform Trial is testing multiple investigational products in parallel and sequentially in persons with ALS with the goal of rapidly identifying novel treatments to slow disease progression. Platform trials have considerable operational and statistical efficiencies compared to typical randomized controlled trials due to their use of shared infrastructure and shared control data. We describe the statistical approaches required to achieve the objectives of a platform trial in the context of ALS. This includes following regulatory guidance for the disease area of interest and accounting for potential differences in outcomes of participants within the shared control (potentially due to differences in time of randomization, mode of administration and eligibility criteria). Within the HEALEY ALS Platform Trial, the complex statistical objectives are met using a Bayesian shared parameter analysis of function and survival. This analysis serves to provide a common integrated estimate of treatment benefit, overall slowing in disease progression, as measured by function and survival while accounting for potential differences in the shared control group using Bayesian hierarchical modeling. Clinical trial simulation is used to provide a better understanding of this novel analysis method and complex design. This article is protected by copyright. All rights reserved.

PMID:37245090 | DOI:10.1002/ana.26714

J Clin Nurs. 2023 May 27. doi: 10.1111/jocn.16769. Online ahead of print.

ABSTRACT

BACKGROUND: Qualified individualised nursing care should be provided to all communities and ethnic groups with free of ethnocentrism.

AIMS: To evaluate nurses’ individualised care behaviours and ethnocentric attitudes and predict the relationship between their individualised care behaviours and ethnocentric attitudes.

DESIGN: A descriptive and exploratory study.

METHODS: This study was conducted with 250 nurses working in a public and two private hospitals in a city, an area with many refugees. Data were collected using the Ethnocentrism Scale and Individualised Care Behaviours Scale. Structural equation model analysis to test hypothetical model and descriptive statistics were used.

RESULTS: Nurses working in the private hospitals had a higher individualised care decision control mean score. Those nurses who enjoyed spending time with people from different cultures had lower mean ethnocentrism scale scores, higher individualised care clinical status, personal life and decision control status subscales mean scores compared to other nurses. Mean scores of the individualised care personal life and decision control status subscales of the nurses who followed the literature on transcultural nursing was higher. A significant relationship between the ethnocentrism levels and individualised care behaviours was identified. Accordingly, the ethnocentric attitudes of the nurses negatively affected their individualised care behaviours, and the model established between the two concepts is statistically appropriate.

CONCLUSIONS: Nurses who work in private hospitals, receive intercultural nursing education and enjoy spending time with different cultures have higher individualised care behaviours and lower ethnocentrism levels. Ethnocentric attitudes of the nurses negatively affected their individualised care behaviours. Care strategies should be developed that consider the factors that will maximize individualised care practices that minimize ethnocentric behaviours among nurses.

IMPLICATIONS FOR THE PROFESSION: Increasing awareness on individualised care behaviours, ethnocentric attitudes and effected factors will contribute to improve of nursing care quality of nurses while giving care to individuals from different cultures.

PMID:37245069 | DOI:10.1111/jocn.16769