Tag: statistics

Phys Rev Lett. 2023 Jun 16;130(24):241402. doi: 10.1103/PhysRevLett.130.241402.

ABSTRACT

We produce gravitational waveforms for nonspinning compact binaries undergoing a quasicircular inspiral. Our approach is based on a two-timescale expansion of the Einstein equations in second-order self-force theory, which allows first-principles waveform production in tens of milliseconds. Although the approach is designed for extreme mass ratios, our waveforms agree remarkably well with those from full numerical relativity, even for comparable-mass systems. Our results will be invaluable in accurately modeling extreme-mass-ratio inspirals for the LISA mission and intermediate-mass-ratio systems currently being observed by the LIGO-Virgo-KAGRA Collaboration.

PMID:37390425 | DOI:10.1103/PhysRevLett.130.241402

Arthritis Rheumatol. 2023 Jun 30. doi: 10.1002/art.42637. Online ahead of print.

ABSTRACT

OBJECTIVE: Preliminary evidence suggests that vagus nerve stimulation (VNS) may have some benefit in patients with rheumatoid arthritis (RA), however prior studies have been small and/or uncontrolled; this study aimed to address that gap.

METHODS: This randomized, double-blind, sham-controlled trial enrolled patients aged 18-75 years with active RA who had failed conventional synthetic disease-modifying antirheumatic drugs (csDMARDs) and were naïve to biologic and/or targeted synthetic DMARDs. All patients received an auricular vagus nerve stimulator and were randomized 1:1 to active stimulation or sham. The primary endpoint was the proportion of patients achieving 20% improvement in American College of Rheumatology criteria (ACR20) at week 12. Secondary endpoints included mean changes in disease activity score of 28 joints with C-reactive protein (DAS28-CRP) and Health Assessment Questionnaire-Disability Index (HAQ-DI).

RESULTS: A total of 113 patients (mean age 54 years; 82% female) enrolled, and 101 patients (89.4%) completed week 12. ACR20 response at week 12 was 25.0% for active stimulation vs 26.9% for sham (difference vs sham [95% CI]: -1.9 [-18.8-14.9], p=0.823). The least square mean (SE) change in DAS28-CRP was -0.95 (0.16) for active stimulation and -0.66 (0.16) for sham (p=0.201); in HAQ-DI it was -0.19 (0.06) for active stimulation and -0.02 (0.06) for sham (p=0.044). Adverse events occurred in 17 patients (15%); all were mild or moderate.

CONCLUSION: Auricular VNS did not meaningfully improve RA disease activity. If VNS with other modalities is pursued in the future for the treatment of RA, larger, controlled studies will be needed to understand its utility. This article is protected by copyright. All rights reserved.

PMID:37390360 | DOI:10.1002/art.42637

Ann Am Thorac Soc. 2023 Jun 30. doi: 10.1513/AnnalsATS.202212-1062OC. Online ahead of print.

ABSTRACT

RATIONALE: Clinical care guidelines advise lung volume recruitment (LVR) be performed routinely by people with neuromuscular disease (NMD), to maintain lung and chest wall flexibility and slow lung function decline. However, the evidence-base is limited and no randomised controlled trials (RCT) of regular LVR in adults have been published.

OBJECTIVE: To evaluate the effect of regular LVR on respiratory function and quality of life in adults with NMD.

METHODS: Randomised controlled trial with assessor blinding, conducted between September 2015 and May 2019. People (>14 years old) with NMD and vital capacity (VC) <80% predicted were eligible, stratified by disease sub-group (amyotrophic lateral sclerosis/motor neurone disease or Other NMDs) and randomised to three months of twice-daily LVR or breathing exercises. The primary outcome was change in maximum insufflation capacity (MIC) from baseline to 3-months, analysed using a linear mixed model approach.

RESULTS: 76 participants (47% female, median age 57 (31-68) years, mean baseline VC 40±18% predicted) were randomised (LVR=37). 73 participants completed the study. There was a statistically significant difference in MIC between groups (linear model interaction effect p=0.002; observed mean difference = 0.19 [0.00 to 0.39] L). MIC increased by 0.13 [0.01 to 0.25] L in the LVR group, predominantly within the first month. No interaction or treatment effects were observed in secondary outcomes of lung volumes, respiratory system compliance or quality of life. No adverse events were reported.

CONCLUSIONS: Regular LVR increased MIC in a sample of LVR-naïve participants with NMD. We found no direct evidence that regular LVR modifies respiratory mechanics or slows the rate of lung volume decline. The implications of increasing MIC are unclear, and the change in MIC may represent practice. Prospective long-term clinical cohorts with comprehensive follow-up, objective LVR usage, and clinically meaningful outcome data are needed.

CLINICAL TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry ACTRN12615000565549 (anzctr.org.au) Primary Source of Funding: National Health and Medical Research Council/Motor Neurone Disease Research Institute of Australia co-funded Postgraduate Scholarship (2014/GNT1093831); Mavis Gallienne MND Victoria grant (GIA 1703); Institute for Breathing and Sleep grants (2014, 2018); Physiotherapy Research Foundation grant (S14-013).

PMID:37390359 | DOI:10.1513/AnnalsATS.202212-1062OC

J Crohns Colitis. 2023 Jun 30:jjad110. doi: 10.1093/ecco-jcc/jjad110. Online ahead of print.

ABSTRACT

BACKGROUNDS AND AIMS: Absence of neutrophils is the minimum standard to consider histological remission of ulcerative colitis (UC). The PICaSSO Histological remission Index (PHRI) is a new simple index for UC based only on the detection of neutrophils. We evaluate PHRI’s correlation with endoscopy and its prognostic value compared to other established indices.

METHODS: Consecutive patients with UC underwent colonoscopy at 2 referral centres (Birmingham, UK and Milan, Italy) and were followed up for 2 years. Correlation between histology (PHRI, Nancy [NHI] and Robarts [RHI]) and endoscopy (Mayo Endoscopic Score [MES]; Ulcerative Colitis Severity Endoscopic Index of Severity [UCEIS], and PICaSSO score) was calculated as Spearman coefficients. Diagnostic performance of endoscopy was assessed with ROC curves and outcome stratification with Kaplan-meier curves.

RESULTS: 192 patients with UC were enrolled, representing all grades of endoscopic severity. Correlation between histology and endoscopy did not differ significantly when using PHRI instead of NHI or RHI. In particular, PHRI’s correlation with MES, UCEIS and PICaSSO was 0.745, 0.718, and 0.694, respectively. Endoscopically-assessed remission reflected the absence of neutrophils (PHRI = 0) with areas under the ROC curve of 0.905, 0.906, and 0.877 for MES, UCEIS, and PICaSSO, respectively. The hazard ratio for disease flare between patients in histological activity/remission was statistically similar (p>0.05) across indexes (2.752, 2.706, and 2.871 for RHI, NHI, and PHRI, respectively).

CONCLUSION: PHRI correlates with endoscopy and stratifies risk of relapse similarly to RHI and NHI. Neutrophil-only assessment of UC is a simple yet viable alternative to established histological scores.

PMID:37390319 | DOI:10.1093/ecco-jcc/jjad110

J Am Acad Orthop Surg. 2023 Jun 30. doi: 10.5435/JAAOS-D-23-00239. Online ahead of print.

ABSTRACT

INTRODUCTION: Replicating native knee kinematics remains the ultimate goal of total knee arthroplasty (TKA). Technology, such as robotics, provides robust intraoperative data; however, no evidence-based targets currently exist for improved clinical outcomes. Furthermore, some surgeons target a rectangular flexion space in TKA unlike the native knee. This study evaluated the effect of in vivo flexion gap asymmetry on patient-reported outcome measures (PROMs) in contemporary TKA.

METHODS: In vivo tibiofemoral joint space dimensions were measured during 129 TKAs using a calibrated tension device before and after complete posterior cruciate ligament resection. PROMs were compared based on the final dimensions and the change in flexion gap dimensions at 90° of flexion: (1) equal laxity, (2) lateral laxity, and (3) medial laxity. Groups did not differ by demographics (P ≥ 0.347), clinical follow-up (P = 0.134), tibiofemoral alignment (P = 0.498), or preoperative PROMs (P ≥ 0.093). Mean follow-up for the cohort was 1.5 years (range, 1-3).

RESULTS: Pain with climbing stairs, pain while standing upright, and knees “always feeling normal” scores were superior for patients with equal or lateral laxity compared with medial laxity (P ≤ 0.064). Pain with level walking, University of California Los Angeles activity level, KOOS JR, and satisfaction scores also tended to be superior for patients with equal or lateral laxity, although it lacked statistical significance (P ≥ 0.111).

DISCUSSION: Results of this study suggest that patients with either an equally tensioned rectangular flexion space or with later-flexion lateral laxity after posterior cruciate ligament resection may achieve superior PROMs. Findings support the clinical benefit of facilitating posterolateral femoral roll back in flexion, which mimics native knee kinematics and further helps define targets for advanced technology.

PMID:37390317 | DOI:10.5435/JAAOS-D-23-00239

Medicine (Baltimore). 2023 Jun 30;102(26):e34128. doi: 10.1097/MD.0000000000034128.

ABSTRACT

The coronavirus disease 2019 has become a threat to global healthcare because of its rapid spread and evolution. In severe cases, the initial management of the disease is mainly supportive therapy and mechanical ventilation. Therefore, we investigated whether a modified emergency department workflow affects the efficacy will influence the efficacy and patient outcomes of traumatic brain injury (TBI) in Taiwan. This retrospective observational study used the Chang Gung Research Database in Taiwan from 7 hospitals in the Chang Gung Memorial Hospital System. Clinical index parameters and treatment efficiencies were analyzed between the locally transmitted period (January 20, 2020-June 7, 2020, period 2) and the community spread period (May 19, 2021-July 27, 2021, period 4) with the same interval of the pre-pandemic in 2019 as a reference period. During the locally transmitted period, only the time interval for patients who had to wait for a brain CT examination was, on average, 7.7 minutes shorter, which reached statistical significance. In addition, the number of TBI patients under 18 years of age decreased significantly during the community spread period. The “Door to the operating room (OR),” with polymerase chain reaction (PCR) testing, was on average 109.7 minutes slower than without the PCR testing in the reference period 2019. TBI treatment efficiency was delayed because of the PCR test. However, the surgical volume and functional outcome during these 2 periods were statistically insignificant compared to the pre-pandemic period because the spread of the virus was well controlled and hospital capacity was increased.

PMID:37390292 | DOI:10.1097/MD.0000000000034128

Medicine (Baltimore). 2023 Jun 30;102(26):e34107. doi: 10.1097/MD.0000000000034107.

ABSTRACT

This study aims to review the 1481 cases of medical complaints from Fujian Provincial Jinshan Hospital in the past 5 years for providing a reference for new hospitals to deal with medical complaints, optimize medical procedures, improve medical quality, and enhance patient experience. The medical complaint information received by the hospital’s medical department and service center accepted and transferred by the health administrative department in the past 5 years was systematically reviewed and statistically analyzed by using hierarchical clustering method. The transfer of the health administration department (61.5%) and the acceptance of the service center (28.9%) were the main sources of medical complaints in hospital. The incidence of medical complaints per 10,000 patients in the hospital was between 3 and 6. The maximum number of complaints was 2017 (5.28 cases/10,000 population), and the least was in 2019 (3.2 cases/10,000 population). The median of complaints was 25, and May to Sep was the period of high incidence of medical complaints each year. In 5 years, the month with the largest number of complaints was May 2020 (41 cases), followed by August 2017(40 cases), and the month with the least number was November 2020 (11 cases). In the past 5 years, the hospital’s medical complaints were mainly in 4 aspects: medical process (n = 329, 22.2%), medical environment (n = 282, 19%), humanistic care (n = 277, 18.7%), and medical management (n = 209, 14.1%). The most frequent complaints were in clinical departments, among which the emergency, outpatient, and pediatric departments accounted for more than 50%. The top 3 complaints were doctors (n = 778, 53%), logistics (n = 284, 19%), and nurses (n = 239, 16%). The main way to resolve complaints was letter and telephone feedback (n = 1372, 92.6%). Our research recommends that new hospitals change their concepts, pay more attention to the services and quality of medical resources and logistical support, follow the best practices of patient-centered, perfect various medical complaint channels, and establish multiple methods. They should also properly accept and dispose medical complaints, improve the timeliness and feedback efficiency of responding to medical complaints, strengthen communication, exchange, and dialogue, and improve patients’ medical experience and sense of gain.

PMID:37390291 | DOI:10.1097/MD.0000000000034107

Medicine (Baltimore). 2023 Jun 30;102(26):e34077. doi: 10.1097/MD.0000000000034077.

ABSTRACT

Amantadine hydrochloride is a risky drug for triggering delirium in dialysis patients; however, it is often administered casually. Furthermore, little is known regarding the recovery and prognosis of dialysis patients with amantadine-associated delirium. Data of this retrospective cohort study were collected from a local hospital database for hospitalizations between January 2011 and December 2020. Patients were divided into 2 cohorts: early recovery (recovery within 14 days) and delayed recovery (recovery more than 14 days). The cases were analyzed together with the intermonth temperature using descriptive statistics. A Kaplan-Meier survival curve and binary logistic regression were applied for the analyses of prognoses and factors. A total of 57 patients were included in this study. The most common symptoms were hallucinations (45.61%) and muscle tremors (43.86%). Early recovery was observed in 63.16% of the patients. Only 3.51% of the cases occurred in local summer (June, July, and August). Better prognoses for survival (hazard ratio [HR] = 0.066, 95% confidence interval [95% CI] = 0.021-0.212) and hospitalization costs (7968.42 ± 3438.43 CNY vs 12852.38 ± 9361.13 CNY, P = .031) were observed in patients with early recovery than in those with delayed recovery. In the multivariate logistic regression adjusted by 1:1 propensity score matching, delayed recovery was independently caused by insomnia (P = .022, = 10.119, 95% CI = 1.403-72.990) and avoided in patients with urine volume over 300 mL (P = .029, = 0.018, 95% CI = 0.006-0.621). The increment (per 100 mg) of cumulative dose (P = .190, = 1.588, 95% CI = 0.395-3.172) tended to be a risk of delayed recovery. The area under curve of the receiver operating characteristic curve was 0.867, with a sensitivity of 90.5% and a specificity of 82.4% at the cutoff point (cutoff = 0.432). For amantadine-associated delirium in dialysis patients with uneven seasonal distribution, early recovery with better prognosis should be the aim of treatment by giving priority to the remedy of insomnia.

PMID:37390288 | DOI:10.1097/MD.0000000000034077

Medicine (Baltimore). 2023 Jun 30;102(26):e34129. doi: 10.1097/MD.0000000000034129.

ABSTRACT

The purpose of this study was to compare the dose distribution characteristics of automatic volume-modulated arc therapy (Auto-VMAT) planning and manual volume-modulated arc therapy (Manual-VMAT) planning of Philips Pinnacle3 9.10 planning system, to provide a basis for optimal radiation therapy planning for cervical cancer. Ten patients with cervical cancer in our hospital from September to December 2018 were selected, and 2 treatment plans, Auto-VMAT plan and Manual-VMAT plan, were designed using Pinnacle3 9.10 planning system, respectively, to evaluate the maximum dose Dmax, mean dose Dmean, homogeneity index of the target area according to the dose volume histogram, the conformability index, plan optimization time, monitor units (MUs), organ at risk and other indicators. The results were that the Auto-VMAT plan was superior to the Manual-VMAT plan for target area Dmean, conformability index, and homogeneity index, with statistically significant differences (P < .05) and no significant difference in maximum dose Dmax (P > .05); rectal V40, V50, and Dmean in the Auto-VMAT plan, bladder V40, V50, and Dmean, small bowel V30, V40, V50 and Dmean, and right and left femoral V50 and Dmean were all lower than the Manual-VMAT plan, and the difference was statistically significant (P < .05); the mean optimization time for the Auto-VMAT and Manual-VMAT plans was 47 minutes and 35 minutes, respectively, an increase of 34%. The average number of MUs was 519 MUs and 374 MUs, respectively, an increase of 28%. This study concluded that the Pinnacle3 9.10-based Auto-VMAT plan was clinically feasible and significantly superior to the Manual-VMAT plan in terms of improved target area uniformity and conformability and reduced organ endangerment dose while reducing the impact of human factors on the quality of plan design.

PMID:37390285 | DOI:10.1097/MD.0000000000034129

Medicine (Baltimore). 2023 Jun 30;102(26):e34046. doi: 10.1097/MD.0000000000034046.

ABSTRACT

BACKGROUND: Restless legs syndrome (RLS) is a common neurological disease that has a significant impact on daily activities and quality of life, for which there is often no satisfactory therapy. Complementary medicine, such as acupressure and hydrotherapy, is used to treat patients with RLS; however, the clinical evidence is unclear. This study aims to investigate the effects and feasibility of self-administered hydrotherapy and acupressure in patients with RLS.

METHODS: This is a randomized, controlled, open-label, exploratory, clinical study with 3 parallel arms, comparing both self-applied hydrotherapy (according to the German non-medical naturopath Sebastian Kneipp) and acupressure in addition to routine care in comparison to routine care alone (waiting list control) in patients with RLS. Fifty-one patients with at least moderate restless-legs syndrome will be randomized. Patients in the hydrotherapy group will be trained in the self-application of cold knee/lower leg affusions twice daily for 6 weeks. The acupressure group will be trained in the self-application of 6-point-acupressure therapy once daily for 6 weeks. Both interventions take approximately 20 minutes daily. The 6-week mandatory study intervention phase, which is in addition to the patient preexisting routine care treatment, is followed by a 6-week follow-up phase with optional interventions. The waitlist group will not receive any study intervention in addition to their routine care before the end of week 12. Outcome parameters including RLS-severity, disease and health-related quality of life (RLS-QoL, SF-12), Hospital Anxiety and Depression Score in German version, general self-efficacy scale, and study intervention safety will be measured at baseline and after 6 and 12 weeks. The statistical analyses will be descriptive and exploratory.

CONCLUSION: In the case of clinically relevant therapeutic effects, feasibility, and therapeutic safety, the results will be the basis for planning a future confirmatory randomized trial and for helping to develop further RLS self-treatment concepts.

PMID:37390284 | DOI:10.1097/MD.0000000000034046