Tag: pubmed

Ann Am Thorac Soc. 2024 Dec 6. doi: 10.1513/AnnalsATS.202407-799OC. Online ahead of print.

ABSTRACT

RATIONALE: Multiple clinical practice guidelines lack recommendations pertaining to non-invasive ventilation (NIV) in acute asthma exacerbations due to a paucity of evidence. However, the evidence syntheses for these guidelines were performed years ago and more recent randomized controlled trials (RCTs) and observational studies have been published.

OBJECTIVE: Update the evidence syntheses from previous guidelines to further clarify the effects of NIV in acute asthma exacerbations.

METHODS: A systematic search of Medline, Embase and the Cochrane Library was conducted, studies comparing NIV plus standard medical therapy to standard medical therapy alone in adults with acute asthma exacerbation were selected using a priori selection criteria, and relevant data were extracted. Weighted aggregation (meta-analysis) was performed to summarize effects, which were appraised using the GRADE (Grading of Recommendations, Assessment, Development, and Evaluation) approach.

RESULTS: Eight RCTs and five observational studies were selected. NIV was associated with a reduced intubation rate (RCTs RR 0.46, CI 0.16-1.29 and observational studies RR 0.55, CI 0.45-0.68), admission rate (RR 0.57, CI 0.34-0.98), and time to improvement in accessory muscle use (Mean difference -1.13 hours, CI -1.28 – -0.99). Additional outcomes favored NIV plus standard medical therapy but didn’t reach statistical significance including dyspnea measures and spirometry measures. There were too few deaths to reliably assess mortality. The quality of evidence ranged from low to very low for all outcomes.

CONCLUSION: All statistically significant outcomes favored NIV plus standard medical therapy over standard medical therapy alone in adults with acute asthma exacerbation. Our aggregate data suggests that intubation rate may be reduced with NIV plus SMT, though the overall quality of the evidence is low. If this is a true effect, it may be clinically important because intubation has been shown to correlate with mortality in multiple observational trials. Given these findings, patients with acute asthma exacerbations may benefit from a trial of NIV in addition to standard medical therapy.

PMID:39642363 | DOI:10.1513/AnnalsATS.202407-799OC

JMIR Res Protoc. 2024 Dec 6;13:e65043. doi: 10.2196/65043.

ABSTRACT

BACKGROUND: Almost 40% of persons living with dementia make an emergency department (ED) visit each year. One of the most impactful and costly elements of their ED care is the decision to discharge or admit them to the hospital-the “disposition” decision. When more than one reasonable option exists regarding a health care decision, such as the decision to admit or not, it often requires a complex conversation between patients, care partners, and ED providers, ideally involving shared decision-making. However, little is known about how these conversations are conducted and the real-world context in which they take place. Best practices in ED communication and shared decision-making for persons living with dementia and their care partners are limited.

OBJECTIVE: This study aims to characterize current practices in ED disposition conversations for persons living with dementia and their care partners, informed by perspectives from patient and care partner participants.

METHODS: This study will use an ethnographic design, including direct observation methods with a semistructured data collection tool to capture the ED encounter for up to 20 patient and care partner dyads, including all discussions about dispositions. Follow-up qualitative, semistructured interviews will be conducted with persons living with dementia and their care partners to explore specific observations made during their ED encounter, and to gain insight into their perspective on their role and elements of decision support used during that conversation.

RESULTS: Data collection was initiated in October 2023, with 13 dyads recruited and observed as of July 2024. This study is expected to be completed by December 2024.

CONCLUSIONS: Novel methods can offer novel insights. By combining direct observation and follow-up interviews about an ED visit, our study design will provide insights into how ED disposition occurs in real-world settings for persons living with dementia. Findings can inform more patient-centered interventions for disposition decision-making.

INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/65043.

PMID:39642361 | DOI:10.2196/65043

Am J Phys Med Rehabil. 2024 Dec 3. doi: 10.1097/PHM.0000000000002675. Online ahead of print.

ABSTRACT

OBJECTIVE: Ideal volume of 5% dextrose (D5W) for median nerve hydrodissection (HD) for treating carpal tunnel syndrome (CTS) is still unknown. This study assessed the efficacy of nerve hydrodissection using varying volumes of D5W for treating mild to moderate CTS.

DESIGN: Eighty participants with unilateral mild to moderate CTS were randomized into groups to receive either 5 ml of normal saline (NS), 5 ml of D5W, 10 ml of NS, and 10 ml of D5W, with each group undergoing one session of ultrasound-guided HD. Visual Analogue Scale (VAS), Boston Carpal Tunnel Syndrome Questionnaire (BCTQ), grip and pinch strength, cross-sectional area (CSA) of median nerve, and electrophysiological assessment were performed at baseline and weeks 4 and 12.

RESULTS: In the 10 ml D5W group, VAS scores considerably improved compared with those in the NS groups. Although nerve CSA values decreased in all groups during follow-ups, the 10 mL D5W group showed a statistically significant improvement compared to the NS groups by the 12th week (p ≤ 0.01).

CONCLUSION: Ultrasound-guided median nerve HD with 10 ml D5W was more effective in reducing pain and nerve size than the NS groups at the 12th week.

PMID:39642354 | DOI:10.1097/PHM.0000000000002675

Am J Phys Med Rehabil. 2024 Dec 3. doi: 10.1097/PHM.0000000000002674. Online ahead of print.

ABSTRACT

OBJECTIVE: The aim of this study was compare the effects of Combined Training (CombT), which included Robot-Assisted Gait Training in addition to Traditional Balance Training (TBT), and TBT alone on balance and fear of falling (FoF) in patients with stroke based on objective assessment methods.

DESIGN: Patients were randomized into CombT Group (CombTG) (n = 21) and TBT Group (TBTG) (n = 21) for duration of 5-weeks. Balance were assessed with EncephaLog App recorded stand-up time (SUT), sit-down time (SDT), and directional sways during walking, Berg Balance Scale (BBS) and Timed Up and Go Test (TUG). International Fall Efficacy Scale (FES-I) measured fear of falling (FoF). Fugl Meyer Assessment-Lower Extremity (FMA-LE) assessed limb impairment. Foot posture were assessed with Foot Posture Index (FPI-6).

RESULTS: After the treatments, EncephaLog sways (anterior, medial, lateral: P = 0.04, P = 0.01, P = 0.02), SUT (P = 0.006), SDT (P = 0.002); BBS (P < 0.001); FES-I (P = 0.002) improved in CombTG. TUG (P = 0.01) and FMA-LE (P < 0.001) improved in TBTG. SUT (P = 0.01) and SDT (P = 0.04) showed statistically significant improvement in CombTG compared to TBTG; FMA-LE (P = 0.002) demonstrated statistically significant improvement in TBTG compared to CombTG.

CONCLUSION: Objective assessment indicated that combined treatments in subacute and chronic stroke rehabilitation enhance balance and reduce FoF more effectively than isolated approaches.

PMID:39642346 | DOI:10.1097/PHM.0000000000002674

Neurology. 2025 Jan 14;104(1):e210079. doi: 10.1212/WNL.0000000000210079. Epub 2024 Dec 6.

ABSTRACT

BACKGROUND AND OBJECTIVES: Disease-modifying treatments (DMTs) are a major unmet need in Parkinson disease (PD). To date, trials investigating DMT candidates in PD most often used a randomized controlled trial (RCT) design. Unfortunately, RCTs to date have not led to a breakthrough, in part because of the large sample sizes and length of follow-up required. In the interest of testing DMT candidates in a more efficient manner, it may be worthwhile to perform futility trials, which are smaller clinical trials that have originally been developed as phase 2 trials in oncology and more recently been used in progressive multiple sclerosis. In this investigation, we used original, patient-level data from DATATOP and PRECEPT, 2 large RCTs in early PD, to explore the feasibility of using the Simon 2-Stage futility trial design in early PD.

METHODS: This is a post hoc analysis of original, patient-level data from the DATATOP and PRECEPT RCTs in early PD. In our analyses, we use descriptive statistics, survival analysis, and binary logistic regression to explore thresholds of change in the Unified Parkinson Disease Rating Scale (UPDRS) motor score as the primary outcome measure, length of follow-up, inclusion and exclusion criteria, and projected sample sizes for Simon 2-Stage futility trials in early PD. We also performed bootstrapping experiments to illustrate the ability of trials using the Simon 2-Stage futility design to identify selegiline as nonfutile and tocopherol as futile.

RESULTS: PRECEPT included 806 participants (mean age 59.7 years, SD 10.3, 64.4% male), and DATATOP included 800 participants (mean age 61.1 years, SD 9.5, 64.4% male). Our analyses suggest that futility trials using the Simon 2-Stage methodology are feasible in PD. We propose a 5-point worsening on the UPDRS motor score as the primary outcome measure and a length of follow-up of 12 months. Trial simulations based on these data suggest the required sample size for such clinical trials to be lower than 200 participants.

DISCUSSION: Based on our analysis of DATATOP and PRECEPT, phase 2 clinical trials using the Simon 2-Stage methodology are feasible in PD and may offer an opportunity to expedite the discovery of promising treatments in early PD.

PMID:39642339 | DOI:10.1212/WNL.0000000000210079

Neurology. 2025 Jan 14;104(1):e210218. doi: 10.1212/WNL.0000000000210218. Epub 2024 Dec 6.

NO ABSTRACT

PMID:39642337 | DOI:10.1212/WNL.0000000000210218

JCO Clin Cancer Inform. 2024 Dec;8:e2400179. doi: 10.1200/CCI-24-00179. Epub 2024 Dec 6.

ABSTRACT

PURPOSE: Oral adjuvant endocrine therapy (AET) reduces the risk of cancer recurrence and death for women with hormone receptor-positive (HR+) breast cancer. Because of adverse symptoms and socioecologic barriers, AET adherence rates are low. We conducted post hoc analyses of a randomized trial of a remote symptom and adherence monitoring app to evaluate characteristics associated with higher app use, satisfaction, and how app use was associated with AET adherence.

METHODS: Patients prescribed AET were randomly assigned to receive one of three intervention conditions: app, app + feedback, or enhanced usual care. Baseline and 6-month follow-up surveys, app use, and pillbox-monitored AET adherence data for app and app + feedback participants were used. Logistic regression evaluated the association between sociodemographic/clinical characteristics and app utilization and satisfaction, and how app use was associated with AET adherence (>80%).

RESULTS: Overall, 163 women with early-stage HR+ breast cancer were included; 35.0% had high app use (≥75% of weeks enrolled). No sociodemographic characteristics were associated with app use. Satisfaction with the app was higher among those who were younger (88.9% for age 31-49 years v 54.9% for age 65+ years, P < .001), identified as White (76.8% v 60.1% for Black, P = .045), had lower health literacy (85.4% v 68.2% with higher health literacy, P = .017), or were nonurban residents (85.7% v 68.6% for urban, P = .021). Most participants (90.3%) with high app use were AET-adherent compared with 66.8% for those with lower app use (P < .001).

CONCLUSION: Use of a remote monitoring app was similar across sociodemographic characteristics, and more frequent app use was associated with a higher likelihood of 6-month AET adherence. Encouraging women to monitor medication adherence and communicate adverse symptoms could improve AET adherence.

PMID:39642329 | DOI:10.1200/CCI-24-00179

NCHS Data Brief. 2024 Nov;(37).

ABSTRACT

OBJECTIVES: This report presents provisional 2023 data on infant mortality rates using the U.S. linked birth/infant death files. Infant mortality rates are shown by infant age at death, maternal race and Hispanic origin, maternal age, gestational age, sex of the newborn, maternal state of residence, and the 10 leading causes of infant death.

METHODS: Data are from the period linked birth/infant death files, which link infant deaths with the corresponding birth certificates. Comparisons are made between provisional 2023 and final 2022 data. The linked birth/infant files are based on 100% of birth certificates and 98%-99% of infant death certificates registered in all states and the District of Columbia. For 2023, 1.2% of infant deaths remained unlinked. Infant deaths in states with less than 100% of infant death records linked to their respective birth records are weighted.

RESULTS: In 2023, the U.S. provisional infant mortality rate was 5.61 infant deaths per 1,000 live births, unchanged from the rate in 2022. From 2022 to 2023, changes in the neonatal mortality rate (from 3.59 to 3.65) and the postneonatal mortality rate (from 2.02 to 1.96) were not statistically significant. Changes in infant mortality rates were not significant by most of the characteristics examined: maternal race and Hispanic origin, maternal age, gestational age, sex, or the 10 leading causes of infant death. By state, infant mortality rates increased in Nevada and Washington and declined in New Mexico and West Virginia.

PMID:39642283

J Cardiovasc Pharmacol. 2024 Dec 1;84(6):565-577. doi: 10.1097/FJC.0000000000001635.

ABSTRACT

In a randomized double-blinded clinical trial of patients with ST segment elevation myocardial infarction (STEMI), goflikicept, an interleukin-1 blocker, significantly reduced systemic inflammation, measured as the area under the curve (AUC) for high-sensitivity C reactive protein at 14 days. We report secondary analyses of biomarkers at 28 days, and cardiac function and clinical end points at 1 year. Patients received a single administration of goflikicept 80 mg (n = 34), goflikicept 160 mg (n = 34), or placebo (n = 34). Both doses of goflikicept significantly reduced the AUC for high-sensitivity C reactive protein at 28 days compared with placebo, without statistically significant differences between the doses. There were no statistically significant differences between groups in the AUC for natriuretic peptides at 28 days. There were no significant differences between placebo, goflikicept 80 mg, and 160 mg groups in deaths (2.9%, 2.9%, and 0%), hospitalization for cardiovascular reasons (9.1%, 5.9%, and 0%), new-onset or progression of heart failure (9.1%, 5.9%, and 5.9%), and new or increased use of loop diuretics (24.2%, 14.7%, and 17.6%), nor in the number of patients with treatment emergent adverse events, with no treatment-related serious adverse events in any group. In conclusion, in patients with STEMI, interleukin-1 blockade with goflikicept 80 mg or 160 mg was well tolerated and associated with significant reduction of systemic inflammation. Further adequately powered studies are warranted to determine whether the reduction in systemic inflammation with goflikicept translates into a clinical benefit in patients with STEMI.

PMID:39642282 | DOI:10.1097/FJC.0000000000001635

J Acquir Immune Defic Syndr. 2025 Jan 1;98(1):12-19. doi: 10.1097/QAI.0000000000003531. Epub 2024 Dec 5.

ABSTRACT

BACKGROUND: The COVID-19 pandemic had great impact on HIV care and prevention worldwide, including in Brazil. We compared HIV testing, recent infection, and annualized incidence according to the COVID-19 pandemic period among cisgender men who have sex with men (MSM) and transgender women (TGW).

SETTING: HIV and sexually transmitted infection testing, prevention, and treatment referral service in Rio de Janeiro, Brazil.

METHODS: We used Maxim HIV-1 Limiting Antigen Avidity EIA as part of a recent infection testing algorithm to identify recent HIV infection cases and estimate annualized HIV incidences in the pre- (March 2018-February 2020) and post-COVID-19 pandemic onset period (March 2020-January 2022). Multivariable logistic regression model assessed factors associated with recent HIV infection.

RESULTS: Among 3814 MSM and 776 TGW, 593 (12.9%) tested positive for HIV and 119 (2.6%) were identified as having recent infection. Percentage of recent HIV infection did not differ between the COVID-19 periods. Overall annualized HIV incidence rates were 6.0% (95% confidence interval [CI]: 4.2 to 7.7) and 6.6% (95% CI: 4.3 to 9.0) in the pre- and post-COVID-19 periods, respectively. During the post-COVID-19 period, higher incidence rates were observed among TGW (8.4% [95% CI: 2.9 to 13.9]), those aged 18-24 years (7.8% [95% CI: 4.0 to 11.7]), of Black race (7.9% [95% CI: 3.8 to 12.0]), and those with <12 years of schooling (7.8% [95% CI: 4.8 to 10.8]). Compared to the pre-COVID-19 period, incidence rates were significantly higher in the post-COVID-19 period for those aged >30 years and TGW, while being lower for those with more years of schooling.

CONCLUSION: HIV incidence estimates remain high among MSM and TGW in Brazil, especially among the most vulnerable. The consequences of the COVID-19 pandemic on the HIV epidemic will likely persist and contribute to worsening HIV outcomes.

PMID:39642281 | DOI:10.1097/QAI.0000000000003531