Category: Nevin Manimala

Front Neurol. 2023 Jun 27;14:1212868. doi: 10.3389/fneur.2023.1212868. eCollection 2023.

ABSTRACT

BACKGROUND: Lymphoplasmapheresis (LPE) is a new therapy developed on the basis of traditional plasma exchange (PE) in combination with leukapheresis. Currently, it remains unclear whether PE and LPE show differences in efficacy for severe MG.

METHODS: A retrospective analysis was conducted on 198 MG patients, 75 in the PE group and 123 in the LPE group, and the patients’ Myasthenia Gravis Foundation of America (MGFA) Clinical Classification was Class IV. The treatment outcome was the change in Quantitative Myasthenia Gravis Score (QMGS) from baseline to the end of treatment. Propensity score matching (PSM) was applied for the balance of confounders between the two groups.

RESULTS: In this study cohort, the safety profile of LPE and PE was good and no serious adverse events were observed. Based on PSM, 62 patients treated with LPE and 62 patients treated with PE were entered into a comparative efficacy analysis. In the PE group, patients underwent a total of 232 replacements, with a mean of 3.74. PE significantly improved the patients’ QMGS performance, with the mean QMGS decreasing from 22.98 ± 4.03 points at baseline to 18.34 ± 5.03 points after treatment, a decrease of 4.68 ± 4.04 points (p < 0.001). A decrease of ≥3 points in QMGS was considered a significant improvement, with a treatment response rate of 67.7% in the PE group. In the LPE group, patients received a total of 117 replacements, with a mean of 1.89. The patients’ mean QMGS was 23.19 ± 4.11 points at baseline and was 16.94 ± 5.78 points after treatment, a decrease of 6.26 ± 4.39 points (p < 0.001). The improvement in QMGS was more significant in patients treated with LPE compared to the PE group (p = 0.039). The treatment response rate in the LPE group was 79%, which was not significantly different compared to the PE group (p = 0.16). The LEP group had a shorter mean length of stay compared to the PE group (10.86 ± 3.96 vs. 12.14 ± 4.14 days), but the difference was not statistically significant (p = 0.13). During the 2-month follow-up period, LPE may be associated with better functional outcomes for patients, with lower QMG score and relapse rate. LPE and PE were both effective in reducing the levels of inflammatory cytokines (TNF-α, IL-1β, and IL-6) and AChR-Ab. Compared to PE, LPE was superior in the reduction of AChR-Ab titer.

CONCLUSION: In severe MG, LPE may be a more preferred treatment option than PE. It achieves treatment outcomes that are not inferior to or even better than PE with fewer replacements. This study provides further evidence to support the application of LPE as a new treatment option for MG.

PMID:37441608 | PMC:PMC10335809 | DOI:10.3389/fneur.2023.1212868

Front Pediatr. 2023 Jun 27;11:1140556. doi: 10.3389/fped.2023.1140556. eCollection 2023.

ABSTRACT

BACKGROUND: Non-pharmaceutical interventions (NPIs), such as social distancing and hand washing, have been associated with a decline in the preterm birth rate worldwide. We aimed to evaluate whether the preterm birth rate in Korea during the coronavirus disease 2019 lockdown has changed compared to that in previous years.

METHOD: A birth registry from the Korea Statistical Information Service, which is a nationwide official database, was used to include all births claimed to have occurred between 2011 and 2020. Newborns with gestational age (GA) less than 22 weeks and birth weight less than 220 g were excluded. The pre-NPI period was designated as January 2011 to January 2020, and the NPI period was defined as February 2020 to December 2020. We assessed the effect of NPI on the incidence of prematurity per 100 births using an interrupted time-series quasi-experimental design and implementing an autoregressive integrated moving average (ARIMA) model.

RESULTS: From 2011 to 2020, a total of 3,931,974 live births were registered, among which 11,416 were excluded. Consequently, the final study population included 3,920,558 live births (both singleton and multiple births) among which 275,009 (7.0%) were preterm. The preterm birth rate was significantly higher during the NPI period (8.68%) compared to that in the pre-NPI period (6.92%) (P < 0.001). The ARIMA model showed that in all singleton and multiple births, except those in July (observed 9.24, expected 8.54, [95% prediction interval {PI} 8.13-8.96], percent difference 7.81%), September (observed 7.89, expected 8.35, [95% PI 7.93-8.76], percent difference -5.66%), and December (observed 9.90, expected 9.40, [95% PI 8.98-9.82], percent difference 5.2%), most observed values were within the 95% PI of the expected values and showed an increasing trend.

CONCLUSION: In this nationwide observational study, the trend in premature birth rate did not significantly change due to NPI implementation in Korea, as it had been increasing since 2011. The trend of Korea’s birth rate appears to be unaffected by the implementation of NPIs; however, further studies with a longer follow-up period are needed.

PMID:37441577 | PMC:PMC10333519 | DOI:10.3389/fped.2023.1140556

Nurs Res. 2023 Jul 11. doi: 10.1097/NNR.0000000000000681. Online ahead of print.

ABSTRACT

BACKGROUND: Little is known about where young adults with chronic illness die in the United States and factors associated with place of death.

OBJECTIVES: This study aimed to examine place of death and factors associated with place of death for young adults with chronic illness using the most recent national data.

METHODS: Our sample (N = 405,535) from the National Center for Health Statistics Division of Vital Statistics death certificate data (2003-2018) included young adults (age 18-39 years) who died from chronic conditions common in childhood or young adulthood. Conditions were grouped by underlying pathophysiology (oncological, cardiovascular, neuromuscular, metabolic, hematological/immunological, renal, chromosomal/congenital, gastrointestinal, respiratory). Place of death was dichotomized into acute care (inpatient, outpatient/emergency room, dead on arrival) or non-acute care (home, hospice, nursing home/long-term care, other, unknown). Examined factors were sex, year of death, age, race (White, Black, Asian/Pacific Islander, American Indian/Alaskan Native), cause of death, and city of residence population (100,000 or greater and under 100,000). Descriptive statistics and logistic regression were used to examine factors related to place of death.

RESULTS: Over half of young adults died in acute care settings. Young adults who were Asian/Pacific Islander or Black or who died from a respiratory or renal cause of death were most likely to die in an acute care setting. Rates of acute care death decreased over the studied years.

DISCUSSION: Many young adults died in an acute care setting. Race and cause of death were the most influential factors associated with place of death. Young adults with an oncological cause of death were less likely to die in an acute care setting than patients with other underlying causes. This may indicate that specific care needs or preferences at the end of life may differ in certain disease populations and may affect place of death. Previous research has shown similar results in other developmental populations; however, given the complex psychosocial concerns that often arise during young adulthood, further research is needed to describe how the young adult status may specifically affect place of death.

PMID:37440265 | DOI:10.1097/NNR.0000000000000681

JAMA Oncol. 2023 Jul 13. doi: 10.1001/jamaoncol.2023.2150. Online ahead of print.

ABSTRACT

IMPORTANCE: In spite of the effectiveness of endocrine therapy plus cyclin-dependent kinase (CDK) 4/6 inhibitors as the first-line treatment for estrogen receptor (ER)-positive, erb-b2 receptor tyrosine kinase 2 (ERBB2 [formerly HER2/neu])-negative (ER+/ERBB2-) metastatic breast cancer (MBC), patients eventually develop resistance, and eventually most will receive chemotherapy. The METEORA-II trial compared a metronomic all-oral treatment with intravenous (IV) chemotherapy.

OBJECTIVE: To compare the efficacy of the oral vinorelbine plus cyclophosphamide plus capecitabine (VEX) regimen vs weekly IV paclitaxel among patients with ER+/ERBB2- MBC who are candidates for chemotherapy.

DESIGN, SETTING, AND PARTICIPANTS: This phase 2 randomized clinical trial including 140 women 18 years and older (randomized 1:1) with ER+/ERBB2- MBC was carried out from September 13, 2017, to January 14, 2021 at 15 centers in Italy. Eligible patients could have received 1 prior line of chemotherapy for MBC and/or 2 lines of endocrine therapy (including CDK4/6 inhibitors).

INTERVENTIONS: In 4-week cycles, patients received either metronomic oral VEX or weekly IV paclitaxel.

MAIN OUTCOMES AND MEASURES: The primary end point was investigator-assessed time to treatment failure (TTF) defined as the interval between the date of randomization to the end of treatment (because of disease progression or lack of tolerability or because further trial treatment was declined). Secondary end points included progression-free survival (PFS), overall survival (OS), and disease control rate (complete or partial response or stable disease lasting for at least 24 weeks).

RESULTS: In total, 133 patients received either VEX (n = 70) or paclitaxel (n = 63) in 4-weekly cycles. The median age was 61 (range, 30-80) years. The VEX treatment significantly prolonged TTF vs paclitaxel (hazard ratio [HR], 0.61; 95% CI, 0.42-0.88; P = .008), median TTF was 8.3 (95% CI, 5.6-11.1) months for VEX vs 5.7 (95% CI, 4.1-6.1) months for paclitaxel, and the 12-month TTF was 34.3% for VEX vs 8.6% for paclitaxel. The median PFS was 11.1 (95% CI, 8.3-13.8) months vs 6.9 (95% CI, 5.4-10.1) months favoring VEX (HR, 0.67; 95% CI, 0.46-0.96, P = .03). The 12-month PFS was 43.5% for VEX vs 21.9% for paclitaxel. No difference in OS was found. The TF event for 55.6% of patients was progression of disease; for 23% it was AEs. More patients assigned to VEX had at least 1 grade 3 or 4 targeted adverse event (VEX, 42.9%; 95% CI, 31.1%-55.3% vs paclitaxel, 28.6%; 95% CI, 17.9%-41.3%), but essentially no alopecia.

CONCLUSION AND RELEVANCE: This randomized clinical trial found significantly prolonged TTF and PFS for oral VEX but no improvement in OS compared with intravenous paclitaxel, despite increased but still manageable toxic effects. The VEX regimen may provide more prolonged disease control than weekly paclitaxel for ER+/ERBB2- MBC.

TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02954055.

PMID:37440239 | DOI:10.1001/jamaoncol.2023.2150

JAMA Netw Open. 2023 Jul 3;6(7):e2323205. doi: 10.1001/jamanetworkopen.2023.23205.

ABSTRACT

IMPORTANCE: Common mental disorders (CMD), which include depression and anxiety, are prevalent among people living with HIV and are associated with suboptimal antiretroviral therapy (ART) adherence.

OBJECTIVE: To assess the effect of a lay health worker-led psychological intervention on ART adherence, virologic suppression, and mental health symptoms.

DESIGN, SETTING, AND PARTICIPANTS: Open-label pragmatic cluster trial with 1:1 block randomization of 16 health facilities in rural Bikita, Zimbabwe. Recruitment occurred from October 2018 to December 2019, and participants were followed up for 12 months, ending in December 2020. Participants were adults aged 18 years and older, who spoke English or Shona, screened positive for CMD (Shona Symptoms Questionnaire [SSQ]-14 score ≥9), received first-line ART for 6 or more months, had no World Health Organization stage 4 disease, no psychosis, were not pregnant, and provided informed consent. Data were analyzed from March 2021 to February 2022.

INTERVENTION: The Friendship Bench, consisting of 6 lay health worker-led weekly problem-solving therapy sessions and optional peer-led group support.

MAIN OUTCOMES AND MEASURES: The primary outcome was mean adherence during 2 to 6 months of follow-up, and the secondary outcomes were mean adherence during 1 to 12 months of follow-up, change in SSQ-14 and Patient Health Questionnaire (PHQ-9) scores (3, 6, 9, and 12 months), and viral load suppression (6 and 12 months).

RESULTS: A total of 516 participants were recruited (244 in Friendship Bench and 272 in enhanced standard care facilities); 438 (84.9%) were female and the mean (SD) age was 45.6 (10.9) years. Mean (SD) adherence between 2 to 6 months was 89.9% (18.4%) in the Friendship Bench group and 87.2% (20.1%) in the control group. The intervention had no statistically significant effect on adherence between 2 to 6 months (unadjusted mean difference, 1.93 percentage points; 95% CI, -1.20 to 5.06 percentage points; P = .23), between months 1 to 12 (mean difference 0.79 percentage points; 95% CI, -2.14 to 3.71 percentage points; P = .60), or viral suppression. Declines in SSQ-14 scores from baseline to 3 months (difference, -1.65; 95% CI, -3.07 to -0.24), 6 months (difference, -1.57; 95% CI, -2.98 to -0.15), and 9 months (difference, -1.63; 95% CI, -3.05 to -0.22) were greater in the Friendship Bench than the standard care group (P < .05). There were no differences in the decline in the SSQ-14 scores from baseline to 12 months and in declines in PHQ-9 scores from baseline to 3, 6, 9, and 12 months.

CONCLUSIONS AND RELEVANCE: In this randomized trial of HIV-positive participants with CMD, the Friendship Bench intervention had no effect on adherence and viral suppression, possibly due to the absence of skill-based adherence training and a ceiling effect.

TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT03704805.

PMID:37440230 | DOI:10.1001/jamanetworkopen.2023.23205

J Music Ther. 2023 Jul 13:thad010. doi: 10.1093/jmt/thad010. Online ahead of print.

ABSTRACT

Change in music therapy is often modeled linearly. In linear analysis, change is represented as the difference between the scores recorded before and after treatment, where changes in the input are proportional to the output. However, changes in complex systems are often not linear and depend on time. We propose Dynamic Systems Theory (DST) as a means to overcome the shortcomings of linear analysis and enrich the study of change in music therapy. This article aims to introduce and critically discuss the applications of DST in music therapy, focusing on its theoretical and methodological aspects. DST offers a meta-framework to model nonlinear change in music therapy, considering time as continuous. The application of DST can further enhance the understanding of how music therapy works, the shape of the change, and how the relevant therapeutic processes within music therapy support therapeutic change. An introduction to DST theory is provided along with its history, implications, assessment methods, statistical analyses, mathematical modeling, and implementation examples in music therapy research.

PMID:37440201 | DOI:10.1093/jmt/thad010

Nucl Med Commun. 2023 Jul 14. doi: 10.1097/MNM.0000000000001735. Online ahead of print.

ABSTRACT

OBJECTIVE: Metastatic castration resistant-prostate cancer (mCRPC) is deadly condition that remains incurable despite various therapies. Initial studies have shown promising results with Lutetium-177 prostate-specific membrane antigen (177Lu-PSMA) therapy for advanced prostate cancer. However, most of the published efficacy and safety data is retrospective. The purpose of the study was to prospectively evaluate the therapeutic efficacy and safety results of 177Lu-PSMA therapy in mCRPC patients after 2 cycles.

METHODS: Twenty-five patients of mCRPC, treated with standard care treatment were enrolled for 2 cycles of 177Lu-PSMA therapy. Prostate-specific antigen (PSA), Eastern Cooperative Oncology Group (ECOG) performance status, Visual Analogue Score (VAS) and Analgesic Quantification Scale (AQS) for efficacy and hemoglobin, total leukocyte, platelets and serum creatinine for toxicity were recorded pre and post-therapy. Paired sample t-test was used for statistical analysis.

RESULTS: Treated patients with mean PSA level of 157 ng/ml received mean dose of 6.84 GBq of 177Lu-PSMA. For PSA, partial response (PR) was seen in 11/25 (44%), stable disease (SD) in 8/25 (32%) and progressive disease (PD) in 6/25 (24%) patients. Grade 1 and 2 hemoglobin toxicity was seen in 5/25 (20%) and 6/25 (24%) patients respectively. No patient developed grade 3 or 4 bone marrow toxicities. Grade 1 and 2 nephrotoxicity was seen in 1 patient each. Statistically significant difference was seen in ECOG, VAS and AQS scores (P < 0.001). No significant nephrotoxicity was observed (P = 0.558).

CONCLUSION: Efficacy and safety of 177Lu-PSMA therapy after 2 cycles have shown significant PSA response and pain palliation in heavily pretreated mCRPC patients.

PMID:37440195 | DOI:10.1097/MNM.0000000000001735

J Hand Surg Eur Vol. 2023 Jul 13:17531934231187553. doi: 10.1177/17531934231187553. Online ahead of print.

ABSTRACT

We developed a classification for open hand fractures based on risk score to predict the risk of infection requiring re-debridement. A total of 846 retrospectively included patients underwent multivariable analysis with backward elimination to derive the predictive risk score from independent predictors. The incidence of infection requiring re-debridement was 4%. Independent predictors include diabetes mellitus or immunocompromised condition, injuries from a bite, fractures with comminution/bone loss, neurovascular injuries and inadequate soft tissue coverage. The area under the receiver operating characteristic curve of the prediction score was 0.79. The new classification system for open hand fractures divides patients into three groups: low-risk open fractures (Type I, score <1); moderate-risk open fractures (Type II, score 1 to 2.5); and high-risk open fractures (Type III, score >2.5), based on the risk of infection requiring re-debridement. Re-debridement and delayed primary closure are suggested for type III open fractures.Level of evidence: III.

PMID:37440189 | DOI:10.1177/17531934231187553

Egypt J Immunol. 2023 Jul;30(3):74-81.

ABSTRACT

Chronic lymphocytic leukemia (CLL) is a malignant blood disorder in which there is an excess of white blood cells (lymphocytes) in blood and lymphoid tissues. CLL patients experience different clinical behaviors with diversity in disease course and outcome. Accordingly, prognostic markers are crucial for employing appropriate therapy protocols. CD163 (cluster of differentiation 163) is a monocyte/macrophage receptor. Soluble CD163 (sCD163) is an emerging prognostic player in the field of hematopoietic neoplasms. This study aimed to assess the prognostic potential of sCD163 as a serological marker in CLL. The study included 41 CLL patients and 44 apparently normal healthy volunteers as controls. Expression of CD38 and cytoplasmic ZAP 70 in CLL cells was assessed using flow cytometry. Beta 2 microglobulin (B2M), sCD23, and sCD163 serological markers were measured by ELISA. Serum levels of sCD163 were statistically significantly higher in CLL cases compared to controls (p=0.000). sCD163 levels were positively correlated with absolute lymphocyte count, sCD23, and B2M levels (p= 0.027, p=0.01, and p=0.004, respectively). In conclusion, levels of sCD163 in CLL is a promising prognostic tool for evaluating disease progression.

PMID:37440184

Cannabis Cannabinoid Res. 2023 Jul 13. doi: 10.1089/can.2022.0338. Online ahead of print.

ABSTRACT

Background: The use of cannabis with various forms of exercise (e.g., running) has received increased media attention in recent years, contradicting the popular stereotype that cannabis is associated with sedentary behavior. Although cross-sectional evidence suggests a positive association between cannabis use and exercise engagement, to date, the acute effects of cannabis on exercise remain unclear. Methods: The present within-subjects crossover study compared participants’ experiences of running after ad libitum use of legal market cannabis (cannabis run) to running without cannabis (non-cannabis run) in a real-world setting. Participants (n=49) were cannabis users between the ages of 21 and 49 years (mean=30.82, standard deviation [SD]=6.21). The majority of participants were male (61.5%) and non-Hispanic White (81.6%). Results: Participants (n=49) ran an average of 3.88 miles (SD=2.28) during their cannabis and non-cannabis runs. Although participants ran an average of 31 seconds/mile slower during their cannabis run, this difference was not statistically significant (p=0.12). Participants reported experiencing (1) less negative affect (p=0.03), (2) greater feelings of positive affect (p<0.001), tranquility (p=0.004), enjoyment (p=0.004), and dissociation (p=0.001), and (3) more runner’s high symptoms (p<0.001) during their cannabis (vs. non-cannabis) runs. Participants also reported lower pain levels after their cannabis (vs. non-cannabis) run (p=0.03). Perceived exertion did not differ between runs (p=0.33). Cannabis form, cannabinoid content, and feelings of “high” were largely unrelated to participants’ experience of exercise while under the influence of cannabis. Conclusions: Results suggest that acute cannabis use may be associated with a more positive exercise experience among regular cannabis users. Research using varied methodologies, a range of exercise modalities, and diverse populations is needed to establish the long-term harms and benefits associated with this behavior, as well as the generalizability of these findings to other populations and settings.

PMID:37440169 | DOI:10.1089/can.2022.0338