Changes In Scale Scores Research Articles

515 - Rapid and early onset of itch relief with tapinarof cream 1% once daily in two pivotal phase 3 trials in adults and children down to two years of age with atopic dermatitis

Abstract Introduction Itch is the most bothersome symptom for patients with atopic dermatitis (AD), with a significant negative impact on health-related quality of life. Rapid onset of pruritus relief with sustained efficacy is a key outcome for AD therapies. In a phase 2 trial in adults and adolescents with moderate to severe AD, tapinarof cream 1% once daily (QD) demonstrated efficacy versus vehicle and was well tolerated. Objective Here, we evaluate time to onset of itch relief in the pivotal phase 3 trials with tapinarof cream 1% QD in the treatment of adults and children down to 2 years of age with AD. Materials and Methods In ADORING 1 and 2, two identical, double-blind, vehicle-controlled trials, patients were randomized 2:1 to tapinarof cream 1% or vehicle QD for 8 weeks. Patients with a Validated Investigator Global Assessment for Atopic DermatitisTM score of ≥3, an Eczema Area and Severity Index score of ≥6, and body surface area involvement of 5–35% were included. Efficacy endpoints that evaluated itch relief were mean changes in Peak Pruritus-Numerical Rating Scale (PP-NRS) score (daily and by visit [Weeks 1, 2, 4, and 8]) from baseline through Week 8. The PP-NRS considers a person’s worst itch over the past 24 hours, assessed on an 11-point scale (0 indicates “no itch” and 10 is “worst imaginable itch”). Daily PP-NRS scores were recorded in diaries. Patients aged ≥12 years self-completed the PP-NRS, while caregivers completed it for children aged <12 years. Results 407 and 406 patients were randomized in ADORING 1 and 2. At baseline, mean (standard deviation [SD]) PP-NRS scores were 6.7 (2.4) and 6.8 (2.3) in both trials, respectively. For daily evaluations of itch from baseline, greater reductions in PP-NRS scores (mean [SD]) for tapinarof versus vehicle were observed as early as Day 1, 24 hours after initial application, in ADORING 1 (–1.2 [2.2] vs –0.9 [2.0]) and Day 2 in ADORING 2 (–1.6 [2.4] vs –1.4 [2.1]). Improvements in daily PP-NRS scores (mean [SD]) with tapinarof versus vehicle continued through the first 2 weeks (Day 14; –3.0 [2.8] vs –2.0 [2.4] and –2.9 [2.7] vs –1.8 [2.6]), and through Week 8 of both trials. There were statistically significant and clinically meaningful reductions in mean weekly PP-NRS scores as early as Week 1, the first assessment, for patients treated with tapinarof compared with vehicle (–2.0 vs –1.2 [P<0.0001]) and (–2.0 vs –1.3 [P=0.0010]), in ADORING 1 and 2, respectively. Significantly greater reductions in mean PP-NRS scores with tapinarof versus vehicle were seen for all visits through Week 8 (–4.1 vs –2.6 and –4.1 vs –2.4 [both P<0.0001]), for both trials. Conclusions Tapinarof cream 1% QD demonstrated rapid, clinically meaningful, and significant onset of pruritus relief as early as 24 hours after initial application compared with vehicle. Improvements in itch with tapinarof cream increased through Week 8 in both trials in adults and children down to 2 years with AD.

Classical TAP vs. I TAP Using the Same Dose of Local Anesthetic in Elective Cesarean Section: A Randomized Controlled Trial.

The effectiveness of postoperative pain control following a Cesarean section influences mother-child attachment, improves early healing, and undoubtedly hastens discharge. Transverse abdominis plane (TAP) and ilioinguinal iliohypogastric (ILIH) blocks have been used to minimize postoperative opioid intake, although their relative effectiveness is unknown. The study aims to determine which procedure was more effective at reducing the need for postoperative rescue analgesics after lower segment Cesarean section (LSCS). TAP block or I TAP (TAP block plus ilioinguinal iliohypogastric nerve block). Both procedures used the same amount of local anesthetic. A sealed envelope technique was used to randomly assign 210 patients who received LSCS into two equal groups to receive either ultrasound (US)-guided TAP block or US-guided ILIH nerve block with US-guided TAP block at the conclusion of the procedure. As per the study protocol, the charge nurse in the postoperative ward gave rescue analgesics to patients who complained of discomfort. At hours 0, 2, 4, 6, 8, 10, and 24 following surgeries, a blinded observer checked on the patient and noted the effectiveness of pain management, the quantity of rescue analgesics used, and patient satisfaction. While there was a substantial decrease in pain score while resting at 2, 3, 4, 8, 12, 16, 20, and 24 postoperative hours in the ITAP group, there was not a significant change in visual analogue scale (VAS) score at the first postoperative hour. However, there was a large delay in the first request for analgesia in the ITAP group (13.15 ± 1.85) as opposed to the TAP group (10.06 ± 1.61) and there was a significant decline in nalbuphine use as well as a higher satisfaction score in the ITAP group. Following LSCS, ITAP block offered better postoperative analgesia than TAP block in terms of quality.

Evaluating the sensitivity of EQ-5D-5L in patients with brain metastases: a secondary analysis of NRG CC001.

EuroQoL EQ-5D is a commonly used measure of health-related quality of life (HRQOL) in clinical trials given the use of its index score as a measure of health utilities. It is unclear whether EQ-5D is sensitive to changes in neurocognitive function and progression that occur following brain radiation. This study sought to evaluate the sensitivity of EQ-5D-5L in reflecting these changes. A secondary analysis of NRG Oncology CC001 was performed. Mean EQ-5D-5L index and visual analog scale (VAS) score changes from baseline between groups of patients stratified by neurocognitive function and intracranial progression status were assessed. MD Anderson Symptom Inventory for brain tumor (MDASI-BT) symptom and interference items were also analyzed between groups. EQ-5D-5L index and VAS score changes between patients who had cognitive failure and those that had preserved cognition showed no significant differences at any time point. In contrast, VAS changes at 4 (1.61 vs -5.13, P = .05) and 6 months (8.17 vs -0.14, P = .04) were significantly improved in the patients who survived without intracranial progression.MDASI-BT cognitive factor scores were significantly improved in the cohort of patients with preserved neurocognitive function at 2 (1.68 vs 2.08, P = .05) and 4 months (1.35 vs 1.83, P = .04). MDASI-BT symptom interference was significantly associated with intracranial progression at 4 months, but not with neurocognitive status. EQ-5D-5L index and VAS scores were not sensitive to neurocognitive changes that patients experienced, but VAS scores were sensitive to progression. This study challenges the routine use of EQ-5D as a QoL metric in brain metastases clinical trials that are focused on preventing neurocognitive dysfunction. NCT# 02360215.

Efficacy and safety of a novel pain management device, AT-04, for endometriosis-related pain: study protocol for a phase III randomized controlled trial

BackgroundEndometriosis-related pain encompassing dysmenorrhea, dyspareunia, and chronic pelvic pain, reduces the quality of life in premenopausal women. Although treatment options for endometriosis alleviate this pain, approximately one-third of women still experience pain even after receiving treatment, indicating the need for novel approaches to pain relief in those women. The Angel Touch device (AT-04) is a portable magnetic fields irradiation device that incorporates a combination of mixed alternative magnetic fields at 2 kHz and 83.3 MHz. A phase III trial confirmed the efficacy and safety of AT-02, a prototype of AT-04, for pain relief in patients with fibromyalgia.MethodsThis is a phase III, multicenter, prospective, randomized, sham device-controlled, double-blind, parallel study. The participants will be premenopausal women aged > 18 years who have endometriosis-related pain with at least moderate severity. Considering dropouts, 50 participants have been deemed appropriate. Eligible women will be centrally registered, and the data center will randomly allocate them in a 1:1 ratio to the intervention and control groups. Women in the intervention group will receive electromagnetic wave irradiation generated by AT-04 and those who in the control group will wear a sham device for 16 weeks, and both groups will wear AT-04 for another 4 weeks. The primary outcome measure is the change in the Numeric Rating Scale score at 16 weeks compared with the baseline. Secondary outcome measures are efficacy for pelvic pain including dysmenorrhea and non-menstrual pain, and chronic pelvic pain not related to menstruation, dysmenorrhea, and dyspareunia, and improvement of quality of life during the study period. Safety will be evaluated by device defects and the frequency of adverse events. The study protocol has been approved by the Clinical Study Review Board of Chiba University Hospital, Chiba, Japan, and will be conducted in accordance with the principles of the Declaration of Helsinki and the Japanese Clinical Trials Act and relevant notifications.DiscussionThis study aims to develop a novel method of managing endometriosis-related pain. The AT-04 is an ultralow-invasive device that can be used without inhibiting ovulation, suggesting potential benefits to women of reproductive-age.Trial registration number Japan Registry of Clinical Trials (jRCTs032230278).

Efficacy and safety of add-on mirogabalin to conventional therapy for the treatment of peripheral neuropathic pain after thoracic surgery: the multicenter, randomized, open-label ADMIT-NeP study

BackgroundFor chronic pain after thoracic surgery, optimal timing of its diagnosis and effective treatment remains unresolved, although several treatment options are currently available. We examined the efficacy and safety of mirogabalin, in combination with conventional pain therapy (nonsteroidal anti-inflammatory drugs and/or acetaminophen), for treating peripheral neuropathic pain (NeP) after thoracic surgery.MethodsIn this multicenter, randomized, open-label, parallel-group study, patients with peripheral NeP were randomly assigned 1:1 to mirogabalin as add-on to conventional therapy or conventional treatment alone.ResultsOf 131 patients of consent obtained, 128 were randomized (mirogabalin add-on group, 63 patients; conventional treatment group, 65 patients). The least squares mean changes (95% confidence interval [CI]) in Visual Analogue Scale (VAS) score for pain intensity at rest from baseline to Week 8 (primary endpoint) were − 51.3 (− 54.9, − 47.7) mm in the mirogabalin add-on group and − 47.7 (− 51.2, − 44.2) mm in the conventional group (between-group difference: − 3.6 [95% CI: − 8.7, 1.5], P = 0.161). However, in patients with Self-administered Leeds Assessment of Neuropathic Symptoms and Signs (S-LANSS) score (used for the screening of NeP) ≥ 12 at baseline, the greater the S-LANSS score at baseline, the greater the decrease in VAS score in the mirogabalin add-on group, while no such trend was observed in the conventional treatment group (post hoc analysis). This between-group difference in trends was statistically significant (interaction P value = 0.014). Chronic pain was recorded in 7.9% vs. 16.9% of patients (P = 0.171) at Week 12 in the mirogabalin add-on vs. conventional treatment groups, respectively. Regarding activities of daily living (ADL) and quality of life (QOL), changes in Pain Disability Assessment Scale score and the EQ-5D-5L index value from baseline to Week 8 showed significant improvement in the mirogabalin add-on group vs. conventional treatment group (P < 0.001). The most common adverse events (AEs) in the mirogabalin add-on group were dizziness (12.7%), somnolence (7.9%), and urticaria (3.2%). Most AEs were mild or moderate in severity.ConclusionsAddition of mirogabalin to conventional therapy did not result in significant improvement in pain intensity based on VAS scores, but did result in significant improvement in ADL and QOL in patients with peripheral NeP after thoracic surgery.Trial registrationJapan Registry of Clinical Trials jRCTs071200053 (registered 17/11/2020).

Modulatory effects of aerobic training on the degree centrality of brain functional activity in subthreshold depression

BackgroundAerobic training has been shown to effectively prevent the progression of depressive symptoms from subthreshold depression (StD) to major depressive disorder (MDD), and understanding how aerobic training promotes changes in neuroplasticity is essential to comprehending its antidepressant effects. Few studies, however, have quantified the alterations in spontaneous brain activity before and after aerobic training for StD. MethodsParticipants included 44 individuals with StD and 34 healthy controls (HCs). Both groups underwent moderate aerobic training for eight weeks, and resting state functional magnetic resonance imaging (rs-fMRI) data were collected before and after training. The degree centrality (DC) changes between the two groups and the DC changes in each group before and after training were quantified. ResultsThe rs-fMRI results showed that compared with the HCs, the DC values of the StD group in the orbital region of the left inferior frontal gyrus significantly depreciated at baseline. After aerobic training, the results of the follow-up examination revealed no significant difference in the DC values between the two groups. In addition, compared with baseline, the StD group exhibited an significant decrease in the DC values of the left dorsolateral superior frontal gyrus; while the HCs group exhibited an significant decrease in the DC values of the left thalamus. No statistically significant connection was seen between changes in DC values and psychological scale scores in the StD group. ConclusionsOur findings suggest that regular aerobic training can enhance brain plasticity in StD. In addition, we demonstrated that DC is a relevant and accessible method for evaluating the functional plasticity of the brain induced by aerobic training in StD.

Effect of deep brain stimulation compared with drug therapy alone on the progression of Parkinson's disease.

Parkinson's disease (PD) symptoms deteriorate with disease progression. Although deep brain stimulation (DBS) can effectively improve the motor signs of PD patients, it is not yet known whether DBS surgery, which is an invasive treatment modality, may change the progression of PD. The aim of this work was to compare the effect of DBS with that of drug treatment on the progression of PD. A total of 77 patients with PD with the Hoehn and Yahr scale (HY) stage of 2.5 or 3 were included, and were divided into 34 in the drug therapy alone group (Drug-G) and 43 in the DBS therapy group (DBS-G). All patients were subjected to a follow-up of 2 years, and disease severity was assessed by the Unified Parkinson's Disease Rating Scale part III (UPDRS-III), the Montreal Cognitive Assessment (MOCA), the Hamilton Anxiety Scale (HAMA), and the Hamilton Depression Scale (HAMD) scores. In addition, the quality of life of patients and the burden on their family were assessed by the 39-item PD questionnaire (PDQ-39) scores, daily levodopa equivalent dose (LED), patient's annual treatment-related costs, and the Zarit Caregiver Burden Scale (ZCBS) score. The changes in relevant scale scores between the two groups were compared at each follow-up stage. The UPDRS-III score of the patients in the "off" state increased from year to year in both groups, and the degree of increase of this score was greater in the DBS-G than in the Drug-G group. The MOCA score in both groups began to decline in the 2nd year of follow-up, and the decline was greater in the Drug-G than in the DBS-G group. DBS treatment did not affect patients' psychiatric disorders. The PDQ39, LED, costs, and ZCBS were negatively correlated with the follow-up time in patients in the DBS-G group, and positively correlated with the follow-up time in patients in the Drug-G. PD is progressive regardless of treatment. The findings from this follow-up study suggest that the disease progression of patients in DBS-G may be slightly faster compared to the drug-G, but the advantages of DBS are also evident. Indeed, DBS better improves patient's motor signs and quality of life and reduces the family burden. In addition, DBS has less impact on patients in terms of cognitive and mental effects.

Ultrasound-guided suprainguinal fascia iliaca block to position the patient for neuraxial anaesthesia in acetabular surgery - a randomized controlled pilot study.

Neuraxial anaesthesia is a common choice for most hip and lower limb operations. Pain associated with positioning is often a deterrent, and the vast literature suggests different regional blocks and opioids for these patients. Patients with acetabular fractures may experience increased pain, and thus are more difficult to position for the neuraxial block. We conducted a randomized controlled pilot study to assess and compare the analgesic efficacy of ultrasound-guided suprainguinal fascia iliaca block (SFICB) versus systemic fentanyl to facilitate positioning for combined spinal epidural (CSE) anaesthesia in patients undergoing acetabular fracture surgery. Twenty patients referred for surgical repair of acetabular fractures were randomly assigned to receive either ultrasound-guided SFICB (group B) or intravenous fentanyl (group F). Changes in visual analogue scale (VAS) scores in supine and sitting position, improvement in sitting angle (SA), positioning quality, rescue analgesic requirement, total opioid consumption, comfort VAS scores, and complications were noted to compare both groups. The post-intervention VAS score in the sitting position was significantly lower in group B than in group F (5.9 ± 2.1 vs. 3.5 ± 1.5, P = 0.01). Group B also had more significant improvement in SA (27.5° (20.75-36.5°), in comparison to group F (10 (5-18.75), P = 0.006). The positioning quality was better in group B, with 70% of patients achieving an optimal position compared to only 10% in group F ( P = 0.02). Ultrasound-guided SFICB, as compared to systemic fentanyl, provided better analgesia and helped to achieve a better and more comfortable position to perform the neuraxial block.

The Medical Student Guide to Pharmacy: Piloting an Interactive Textbook on Basic Pharmacology Principles and Clinical Correlations.

Despite the wide use of medications in clinical practice, graduating medical students often feel unprepared for the task of prescribing upon starting residency. With recent educational initiatives aiming to transform learning modalities, we sought to pilot an interactive textbook on basic pharmacology principles at our institution as a supplement to first-year lectures and assess its subjective impact on students' knowledge of content as well as confidence to apply material in the real world through pre- and post-intervention surveys. First-year medical students were invited to complete non-validated, voluntary, anonymous, emailed, online surveys consisting of Likert scale and free-text response questions. Our investigation served as a pilot test for future iterations of this research. Response rates for the pre- and post-intervention surveys were 73/145 (50%) and 38/145 (26%), respectively, with the post-intervention survey further reduced to 13 individuals who indicated use of the interactive textbook. Questions regarding interactive textbook chapters that overlapped with course content were excluded from data analysis due to an inability to separate learning gains from lectures versus the interactive textbook. Post-intervention survey responses all showed significant changes in mean Likert scale scores on student-perceived knowledge and confidence to apply material with P < .001. Free-text response questions revealed limited exposure to the field of pharmacy and interactions with pharmacists prior to medical school. Our pilot study on the initial use of an interactive textbook titled The Medical Student Guide to Pharmacy presented us with valuable insight into providing first-year medical students with a clinically oriented supplemental resource within coursework on basic pharmacology. Challenges for the future include better integrating the interactive textbook into class lectures to facilitate increased use by students as well as developing more targeted, validated assessments of the impact it has on students' learning.

Transient Worsening of Pain After Administration of Immune Checkpoint Inhibitors - A Case Series.

Transient pain enhancement or flare pain, is observed following the administration of immune checkpoint inhibitors (ICIs). However, the detailed mechanism of this phenomenon remains unclear. In this report, we present our experience of documenting the course of flare pain following ICI administration in six cases. Six patients with advanced solid tumors received ICI monotherapy between July 2017 and November 2019. Their pain increased within hours of ICI administration despite being stable before ICI administration. We evaluated the changes in the numerical rating scale (NRS) score over 72 h after ICI administration. Four non-small cell lung cancer patients, one gastric cancer patient, and one renal cell cancer patient were included. Four patients experienced an increase in NRS, as evidenced by scores on two or more scales compared to the day before administration, whereas two patients showed an increase only on one scale. The NRS score decreased to almost the same level as that on the day before administration. Flare pain is observed in the same area as the primary site. Most of the pain was alleviated without the need for rescue analgesics, although one patient experienced a 4-point increase in the NRS scale. Flare pain may occur following ICI administration. Healthcare providers should be aware of these events and provide patients with suitable information and coping techniques.

Modulation of High‐Frequency rTMS on Reward Circuitry in Individuals with Nicotine Dependence: A Preliminary fMRI Study

Although previous studies have shown that repetitive transcranial magnetic stimulation (rTMS) can ameliorate addictive behaviors and cravings, the underlying neural mechanisms remain unclear. This study aimed to investigate the effect of high‐frequency rTMS with the left dorsolateral prefrontal cortex (L‐DLPFC) as a target region on smoking addiction in nicotine‐dependent individuals by detecting the change of spontaneous brain activity in the reward circuitry. We recruited 17 nicotine‐dependence participants, who completed 10 sessions of 10 Hz rTMS over a 2‐week period and underwent evaluation of several dependence‐related scales, and resting‐state fMRI scan before and after the treatment. Functional connectivity (FC) analysis was conducted with reward‐related brain regions as seeds, including ventral tegmental area, bilateral nucleus accumbens (NAc), bilateral DLPFC, and bilateral amygdala. We found that, after the treatment, individuals showed reduced nicotine dependence, alleviated tobacco withdrawal symptoms, and diminished smoking cravings. The right NAc showed increased FC with right fusiform gyrus, inferior temporal gyrus (ITG), calcarine fissure and surrounding cortex, superior occipital gyrus (SOG), lingual gyrus, and bilateral cuneus. No significant FC changes were observed in other seed regions. Moreover, the changes in FC between the right NAc and the right ITG as well as SOG before and after rTMS were negatively correlated with changes in smoking scale scores. Our findings suggest that high‐frequency L‐DLPFC‐rTMS reduces nicotine dependence and improves tobacco withdrawal symptoms, and the dysfunctional connectivity in reward circuitry may be the underlying neural mechanism for nicotine addiction and its therapeutic target.

Impact of Switching From Immediate- or Prolonged-Release to Once-Daily Extended-Release Tacrolimus (LCPT) on Tremor in Stable Kidney Transplant Recipients: The Observational ELIT Study.

Once-daily extended-release tacrolimus (LCPT) exhibits increased bioavailability versus immediate-release (IR-TAC) and prolonged release (PR-TAC) tacrolimus. Improvements in tremor were previously reported in a limited number of kidney transplant patients who switched to LCPT. We conducted a non-interventional, non-randomized, uncontrolled, longitudinal, prospective, multicenter study to assess the impact of switching to LCPT on tremor and quality of life (QoL) in a larger population of stable kidney transplant patients. The primary endpoint was change in The Essential Tremor Rating Assessment Scale (TETRAS) score; secondary endpoints included 12-item Short Form Survey (SF-12) scores, tacrolimus trough concentrations, neurologic symptoms, and safety assessments. Subgroup analyses were conducted to assess change in TETRAS score and tacrolimus trough concentration/dose (C0/D) ratio by prior tacrolimus formulation and tacrolimus metabolizer status. Among 221 patients, the mean decrease of TETRAS score after switch to LCPT was statistically significant (p < 0.0001 vs. baseline). There was no statistically significant difference in change in TETRAS score after switch to LCPT between patients who had received IR-TAC and those who had received PR-TAC before switch, or between fast and slow metabolizers of tacrolimus. The overall increase of C0/D ratio post-switch to LCPT was statistically significant (p < 0.0001) and from baseline to either M1 or M3 (both p < 0.0001) in the mITT population and in all subgroups. In the fast metabolizers group, the C0/D ratio crossed over the threshold of 1.05ng/mL/mg after the switch to LCPT. Other neurologic symptoms tended to improve, and the SF-12 mental component summary score improved significantly. No new safety concerns were evident. In this observational study, all patients had a significant improvement of tremor, QoL and C0/D ratio post-switch to LCPT irrespective of the previous tacrolimus formulation administered (IR-TAC or PR-TAC) and irrespective from their metabolism status (fast or slow metabolizers).

The Feasibility and Effects of Self-Acupressure on Symptom Burden and Quality of Life in Hemodialysis Patients: A Pilot RCT.

Symptom burden among long-term hemodialysis (HD) patients is high, and addressing symptoms has been identified as a key research priority by patients. Acupressure has shown some effectiveness in management of symptoms in patients with HD. The purpose of this study was to explore the feasibility and the effect of implementing a self-administered acupressure intervention on symptom burden and quality of life for in-center HD patients. A pilot randomized controlled study. Two outpatient community HD clinics between in Calgary, Alberta, Canada. Patients on HD for at least 3 months and with at least one symptom score rated greater than moderate were eligible for the study. Participants were randomized into either the (1) self-acupressure + usual care or (2) usual care alone group. Participants in the acupressure group were given a wooden acupressure tool and taught how to self-administer protocol on 6 acupressure sites for the 4-weeek study duration. Feasibility outcomes were assessed through satisfaction surveys and attrition. Other outcomes included quality of life and symptom scores by validated questionnaires (EQ-5D-5L and Integrated Palliative Outcome Score-Renal [IPOS-Renal]). Thirty-two participants were successfully enrolled in the study; acceptability was high with study completion at 98% in the intervention group and 82% adherence rate to the 4-week protocol. Participants in the intervention group reported an improved change score in quality of life (EQ-5D-5L Index Score change = +0.053; EQ-5D-5L visual analog scale score change = +6.7). Participants in the intervention group also reported improved symptom scores (IPOS-Renal overall change = -2.8). Small sample size and intervention duration are limitations of this pilot study. The results from this study suggest that self-acupressure was acceptable and feasible in this sample of HD patients. Self-acupressure may have a role for supporting the management of symptoms in HD patients. These pilot results can be used to inform larger more definitive investigations.

The Effect of Social Media Addiction on Premenstruel Syndrome and Sleep Quality

Objective: This study was conducted to determine the impact of social media addiction on premenstrual syndrome (PMS) and sleep quality. Material-Method: The study population consisted of female students enrolled in the Health Sciences Faculty of a public university (n=884). Data were collected using the "Personal Information Form," "Social Media Addiction Scale (SMAS)," "Premenstrual Syndrome Scale (PMSS)," and "Pittsburgh Sleep Quality Index (PSQI)" instruments. Descriptive statistics, Pearson correlation analysis and Linear Regression Analysis were used for statistical evaluation. Results: The mean age of the students was 20.40±1.65, and the mean age of menarche was 13.42±1.60. The mean total score for PMSS was 129.57±37.75, the mean total score for SMAS was 12.93±4.84, and the mean score for PSQI was 13.22±2.04. The correlation analysis revealed a positive relationship between SMAS and the total scores of PMSS and PSQI (r=.325, p=.000; r=271, p=.000). In addition, as a result of the regression analysis, a 1-unit change in the social media addiction scale score causes a positive increase of .325 units (β) on the total score of the premenstrual syndrome scale and a positive increase of 0.444 units (β) on the total score of the PSQI. Conclusion: Social media addiction was found to be an effective variable in increasing premenstrual syndrome symptoms and poor sleep quality.

ASSESSING THE IMPLEMENTATION OF COVID-19 INFECTION CONTROL BEST PRACTICES IN NURSING HOMES

Abstract The COVID-19 pandemic has claimed over a million lives in the United States, with nursing homes suffering over 158,000 deaths through 2022. In a cluster randomized controlled trial (RCT) with 136 nursing homes, we delivered best-practice training to improve COVID-19 infection control practices. We sought to assess the implementation of infection control practices in participating nursing homes using Project ECHO (Extension for Community Health Outcomes) as an implementation strategy. We delivered a 16-week infectious disease and quality improvement training via real-time, interactive videoconferencing. We surveyed nursing home administrators (NHAs) and nursing staff at baseline and 6-month follow-up. Using validated items from the Centers for Disease Control and Prevention (CDC), the surveys inquired about 80 infection control best-practice activities (yes/no) related to preparedness, visitation policies, communication, protocols, management of deceased residents, education, staffing, personal protective equipment (PPE), and hygiene practices. We also assessed readiness for change and implementation climate in nursing homes with validated scales. We assessed changes in infection control practices and implementation scale scores between baseline and 6-month follow-up. A total of 197 unique participants from 126 nursing homes responded to our surveys. We found that visitation decisions were less likely made on a case-by-case basis by the end of 6 months (91% vs.76%, p=0.025) and an increase in informational materials developed for residents and families at the appropriate reading level (88% vs. 100%, p=0.021) was observed. We also saw changes in some individual items, e.g., an increase in delegating to non-physician staff

Patterns of neuromyelitis optica spectrum disorder attacks in different age groups and sexes depending on the status of immunosuppressive therapy: A retrospective cohort study.

The association between onset age and sex with relapse risk in neuromyelitis optica spectrum disorder (NMOSD) remains inconclusive. We aimed to describe the clinical features of patients with NMOSD in different age groups and sexes and to analyse relapse characteristics pre- and post-immunosuppressive therapy (IST). Patients with NMOSD were retrospectively reviewed from our clinical centre's database. Demographic and clinical data, attack presentation, and disease course pre- and post-IST were investigated. We also analysed the effect of onset age on the annualized relapse rate and relapse risk according to sex and IST status. Interactions on the additive scale between onset age and sex were analysed. A restricted cubic spline was used to analyse potential nonlinear correlations. Longitudinal changes in the Expanded Disability Status Scale score across NMOSD attacks were analysed using linear mixed-effect models. In total, 533 patients experienced 1394 attacks pre-IST and 753 relapses post-IST. Older age at onset was correlated with more myelitis attacks but fewer optic neuritis attacks, with no sex-related differences in attack presentation. Pre-IST, relapse risk increased with age at onset in women, while a U-shaped correlation between onset age and relapse risk was found in men. Post-IST, an inverted U-shaped association between the predicted relapse risk and onset age was observed in women. Conversely, a negative correlation between the predicted relapse risk and onset age was found in men. Overall, a higher ratio of myelitis attacks was found post-IST. Patients of different onset ages and sexes had different relapse patterns before and after IST.

Maintenance of the synergistic effects of cord blood cells and erythropoietin combination therapy after additional cord blood infusion in children with cerebral palsy: 1-year open-label extension study of randomized placebo-controlled trial

BackgroundThis 1-year open-label extension study aimed to identify the persistent synergistic effects of allogeneic umbilical cord blood (UCB) cells and erythropoietin (EPO) in children with cerebral palsy (CP) for up to 2 years.MethodsThis open-label extension study followed children with CP who were enrolled in the previous randomized, double blind, placebo-controlled trial. The following groups from the first trial were maintained: (A) UCB + EPO, (B) UCB, (C) EPO, and (D) only placebo, and all the participants had continued active rehabilitation. This extended study started 3 months after termination of the first trial, which had a 1-year follow-up duration. All subjects received single additional UCB intravenous infusion at the extension baseline regardless of their initial allocation. Outcome measures were the gross motor performance measure (GMPM), gross motor function measure-66 (GMFM-66), and Bayley scales of infant development-II (BSID-II), which were followed at 3, 6, and 12 months after the extension baseline. Changes in the outcome scores from the baseline values of the previous trial and this study were analysed.ResultsSixty-nine children (4.29 ± 1.28 years, M:F = 34:35) were included in this study. Each group showed improvements in the outcome measures at 12 months after additional UCB infusion compared to the baseline scores, except for GMFM and GMPM in Group C which were elevated at 3 and 6 months post-therapy. Total subject analyses did not show significant differences in the outcome measures between the four different groups at 3, 6 and 12 months after additional UCB therapy. However, patients with severe dysfunction, whose GMFCS levels were IV and V, revealed a larger improvement of the GMPM score in Group A than in Group D (Ps < 0.05) from the baseline value of the previous trial. The changes in BSID-II mental scale scores were positively correlated with the number of administered total nucleated cells per unit body weight during this one-year extension study period (r = 0.536, P = 0.001).ConclusionsThese results suggest that when administering UCB to treat patients with CP, combination therapy with EPO is more effective, and the effect might last as long as 2 years, especially in patients with severe impairments.Trial registration: CHA Bundang Medical Center IRB, No. 2015–06-093, approved on July 29, 2015, (https://www.e-irb.com:3443/devlpg/nlpgS200.jsp), ClinicalTrials.gov, NCT03130816, retrospectively registered on April 27, 2017 (https://clinicaltrials.gov/ct2/show/NCT03130816?term=NCT03130816&draw=2&rank=1).

Multiorgan Dysfunction Syndrome in Abusive and Accidental Pediatric Traumatic Brain Injury.

Abusive head trauma (AHT) is a mechanism of pediatric traumatic brain injury (TBI) with high morbidity and mortality. Multiorgan dysfunction syndrome (MODS), defined as organ dysfunction in two or more organ systems, is also associated with morbidity and mortality in critically ill children. Our objective was to compare the frequency of MODS and evaluate its association with outcome between AHT and accidental TBI (aTBI). This was a single center, retrospective cohort study including children under 3 years old admitted to the pediatric intensive care unit with nonpenetrating TBI between 2014 and 2021. Presence or absence of MODS on days 1, 3, and 7 using the Pediatric Logistic Organ Dysfunction-2 score and new impairment status (Functional Status Scale score change > 1 compared with preinjury) at hospital discharge (HD), short-term timepoint, and long-term timepointwere abstracted from the electronic health record. Multiple logistic regression was performed to examine the association between MODS and TBI mechanism with new impairment status. Among 576 children, 215 (37%) had AHT and 361 (63%) had aTBI. More children with AHT had MODS on days 1 (34% vs. 23%, p = 0.003), 3 (28% vs. 6%, p < 0.001), and 7 (17% vs. 3%, p < 0.001) compared with those with aTBI. The most common organ failures were cardiovascular ([AHT] 66% vs. [aTBI] 66%, p = 0.997), neurologic (33% vs. 16%, p < 0.001), and respiratory (34% vs. 15%, p < 0.001). MODS was associated with new impairment in multivariable logistic regression at HD (odds ratio 19.1 [95% confidence interval 9.8-38.6, p < 0.001]), short-term discharge (7.4 [3.7-15.2, p < 0.001]), and long-term discharge (4.3 [2.0-9.4, p < 0.001])]. AHT was also associated with new impairment at HD (3.4 [1.6-7.3, p = 0.001]), short-term discharge (2.5 [1.3-4.7, p = 0.005]), and long-term discharge (2.1 [1.1-4.1, p = 0.036]). Abusive head trauma as a mechanism was associated with MODS following TBI. Both AHT mechanism and MODS were associated with new impairment at all time points.

PP81 Efficacy Of Transcranial Direct Current Stimulation For Depressive Episode Disorders

IntroductionDepression is a general term that describes different depressive disorders which are highly prevalent and disabling, characterized by decreases in quality of life. Transcranial Direct Current Stimulation (tDCS) is a non-invasive brain modulation technique used, among other purposes, for the treatment of chronic pain and headache. In order to clarify the effect of this stimulation on depressive disorders, the objective of this review was to evaluate efficacy and safety of treatment with tDCS for depressive disorders.MethodsA systematic research study was carried out on 30 June 2022 in MEDLINE (by Pubmed), Embase, Literatura Latino-Americana e do Caribe em Ciências da Saúde (LILACS), PsycInfo e Global Mental Health databases. Were included systematic reviews (SR) with meta-analysis that selected patients with depression, in use of tDCS, using as comparator sham stimulation (placebo) or any other treatment (pharmacologic or no) or any comparison between pre-and post-intervention.ResultsEight SR with meta-analysis of randomized clinical trials (RCTs) on the efficacy and safety of tDCS in the treatment of depressive disorders were retrieved. Subjects were assessed for clinical response, remission, change in scores on depression scales, occurrence of procedure-related adverse events, and treatment dropout. Three systematic reviews showed results that point to the effectiveness of tDCS for the clinical response outcome and one considering the remission outcome. As for the outcome measured by the change in depression scale scores, all included reviews showed favorable results for tDCS. It is noteworthy that the studies included in the reviews have methodological limitations. With regard to safety, an increased risk treatment-emergent mania or hypomania (TEM) has been observed.ConclusionsThe tDCS association with antidepressants showed favorable results to this technology in a sample with depression and varied clinical characteristics. Regarding safety of this technology, tDCS did not show adverse effects of greater severity, but was verified to have an increased risk of TEM.

Naloxone use by Aotearoa New Zealand emergency medical services, 2017-2021.

Emergency medical services (EMS) use of naloxone in the prehospital setting is indicated in patients who have significantly impaired breathing or level of consciousness when opioid intoxication is suspected. The present study characterised naloxone use in a nationwide sample of Aotearoa New Zealand road EMS patients to establish a baseline for surveillance of any changes in the future. A retrospective analysis of rates of patients with naloxone administrations was conducted using Hato Hone St John (2017-2021) and Wellington Free Ambulance (2018-2021) electronic patient report form datasets. Patient demographics, presenting complaints, naloxone dosing, and initial and last vital sign clinical observations were described. There were 2018 patients with an equal proportion of males and females, and patient median age was 47 years. There were between 8.0 (in 2018) and 9.0 (in 2020) naloxone administrations per 100 000 population-years, or approximately one administration per day for the whole country of 5 million people. Poisoning by unknown agent(s) was the most common presenting complaint (61%). The median dose of naloxone per patient was 0.4 mg; 85% was administered intravenously. The median observed change in Glasgow Coma Scale score was +1, and respiratory rate increased by +2 breaths/min. A national rate of EMS naloxone patients was established; measured clinical effects of naloxone were modest, suggesting many patients had reasons other than opioid toxicity contributing to their symptoms. Naloxone administration rates provide indirect surveillance information about suspected harmful opioid exposures but need to be interpreted with care.