A Systematic Review and Meta-Analysis of Randomised Controlled Trials

[Posted 24/Oct/2023]

AUDIENCE: Nursing

KEY FINDINGS: Patients with heart failure benefit from home-based cardiac telerehabilitation intervention. With the rapid development of information and communication technology, home-based cardiac telerehabilitation has great potential and may be used as an adjunct or substitute for centre-based cardiac rehabilitation.

BACKGROUND: Purpose of this study is to evaluate the effectiveness of home-based cardiac telerehabilitation in patients with heart failure.

DETAILS: This systematic review and meta-analysis of randomised controlled trials were designed and reported in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. Two researchers independently screened eligible studies. The Cochrane Handbook for Systematic Reviews of Interventions was used to assess the risk of bias within the included studies. A fixed- or random-effects meta-analysis model was used to determine the mean difference, based on the results of the heterogeneity test. A total of 2291 studies were screened. The meta-analysis included data from 16 studies representing 4557 participants. The results indicated that home-based cardiac telerehabilitation could improve heart rate, VO2 peak, 6-minute walk distance, quality of life and reduce readmission rates. No significant differences were observed in the left ventricular ejection fraction percentages between the home-based cardiac telerehabilitation and usual care groups. Compared with centre-based cardiac rehabilitation, home-based cardiac telerehabilitation showed no significant improvement in outcome indicators.

Copyright © John Wiley & Sons Ltd. All rights reserved.

Source: Gao, Y., Wang, N., Zhang, L., et al. (2023). Effectiveness of Home-Based Cardiac Telerehabilitation in Patients With Heart Failure: A Systematic Review and Meta-Analysis of Randomised Controlled Trials. J Clin Nurs. 2023; 32(21-22): 7661-7676. Published: October, 2023. DOI: 10.1111/jocn.16726.

A WHO Systematic Analysis

[Posted 24/Mar/2025]

AUDIENCE: Ob/Gyn, Family Medicine, Nursing

KEY FINDINGS: Haemorrhage remains the leading cause of death, despite the existence of effective clinical interventions, emphasising the need for improved access to quality health care. The timing of most deaths in the postpartum period demands renewed commitment to improving the provision of postpartum care in addition to intrapartum care. Indirect causes of death require health system approaches to integrate obstetric and non-obstetric care.

BACKGROUND: Maternal mortality is not on track to meet Sustainable Development Goal (SDG) target 3.1 of a global maternal mortality ratio below 70 per 100,000 livebirths by 2030. Updated evidence on causes of death is needed to accelerate progress.

DETAILS: Authors conducted a multi-strategy systematic review to identify causes of maternal deaths occurring in 2009-20. Data sources included civil registration and vital statistics systems data from the WHO Mortality Database, reports published by Member States, and national and subnational journal articles identified via bibliographic databases. Authors used a Bayesian hierarchical model to estimate the maternal cause of death distribution by SDG regions and worldwide. Given the paucity of data on maternal suicide and late maternal deaths occurring beyond 42 days postpartum, additional analyses were conducted to estimate the proportion of maternal deaths from suicide and the ratio of maternal to late maternal deaths (all cause). Globally, the most common cause of maternal death was haemorrhage (27%; 80% uncertainty interval 22-32), followed by indirect obstetric deaths (23%, 18-30), and hypertensive disorders (16%, 14-19). The proportion of haemorrhage deaths varied substantially by region and was highest in sub-Saharan Africa and Western Asia and Northern Africa. The proportion of maternal deaths from hypertensive disorders was highest in Latin America and the Caribbean. Most maternal deaths from haemorrhage and sepsis occurred during the postpartum period. Only 12 countries recorded one or more maternal suicides; of those countries, the proportion of deaths from suicide ranged from below 1% to 26% of maternal deaths. For countries reporting at least one late maternal death (ie, deaths that occur more than 42 days but less than 1 year after the termination of pregnancy), the ratio of late maternal deaths to maternal deaths up to 42 days ranged from <0.01 to 0.07.

Copyright © World Health Organization and The Author(s); licensee Elsevier Ltd. All rights reserved.

Source: Cresswell, J. A., Alexander, M., Chong, M. Y. C., et al. (2024). Global and Regional Causes of Maternal Deaths 2009-20: A WHO Systematic Analysis. The Lancet Global Health. 2025; Published: March 5, 2025. DOI: 10.1016/S2214-109X(24)00560-6.

A Phase 3 Randomized Clinical Trial

[Posted 11/Mar/2025]

AUDIENCE: Psychiatry, Family Medicine, Nursing

KEY FINDINGS: Results of this randomized clinical trial show that brexpiprazole + sertraline combination treatment statistically significantly improved PTSD symptoms vs sertraline + placebo, indicating its potential as a new efficacious treatment for PTSD. Brexpiprazole + sertraline was tolerated by most participants, with a safety profile consistent with that of brexpiprazole in approved indications.

BACKGROUND: New pharmacotherapy options are needed for posttraumatic stress disorder (PTSD). Purpose of this study is to investigate the efficacy, safety, and tolerability of brexpiprazole and sertraline combination treatment (brexpiprazole + sertraline) compared with sertraline + placebo for PTSD.

DETAILS: This was a parallel-design, double-blind, randomized clinical trial conducted from October 2019 to August 2023. The study had a 1-week, placebo run-in period followed by an 11-week, double-blind, randomized, active-controlled, parallel-arm period (with 21-day follow-up) and took place at 86 clinical trial sites in the US. Adult outpatients with PTSD were enrolled (volunteer sample). The primary end point was change in Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) total score (which measures the severity of 20 PTSD symptoms) from randomization (week 1) to week 10 for brexpiprazole + sertraline vs sertraline + placebo. Safety assessments included adverse events. A total of 1327 individuals were assessed for eligibility. After 878 screen failures, 416 participants (mean [SD] age, 37.4 [11.9] years; 310 female [74.5%]) were randomized. Completion rates were 137 of 214 participants (64.0%) for brexpiprazole + sertraline and 113 of 202 participants (55.9%) for sertraline + placebo. At week 10, brexpiprazole + sertraline demonstrated statistically significant greater improvement in CAPS-5 total score (mean [SD] at randomization, 38.4 [7.2]; LS mean [SE] change, -19.2 [1.2]; n = 148) than sertraline + placebo (randomization, 38.7 [7.8]; change, -13.6 [1.2]; n = 134), with LS mean difference, -5.59 (95% CI, -8.79 to -2.38; P .001). All key secondary and other efficacy end points were also met. Treatment-emergent adverse events with incidence of 5% or greater for brexpiprazole + sertraline (and corresponding incidences for sertraline + placebo) were nausea (25 of 205 [12.2%] and 23 of 196 [11.7%]), fatigue (14 of 205 [6.8%] and 8 of 196 [4.1%]), weight increase (12 of 205 [5.9%] and 3 of 196 [1.5%]), and somnolence (11 of 205 [5.4%] and 5 of 196 [2.6%]). Discontinuation rates due to adverse events were 8 of 205 participants (3.9%) for brexpiprazole + sertraline and 20 of 196 participants (10.2%) for sertraline + placebo.

Copyright © American Medical Association. All Rights Reserved.

Source: Davis, L. L., Behl, S., Lee, D., et al. (2024). Brexpiprazole and Sertraline Combination Treatment in Posttraumatic Stress Disorder: A Phase 3 Randomized Clinical Trial. JAMA Psychiatry. 2025; 82(3): 218-227. Published: March, 2025. DOI: 10.1001/jamapsychiatry.2024.3996.

[Posted 4/Mar/2025]

AUDIENCE: Nursing

KEY FINDINGS:

BACKGROUND: Diaper rash is a frequent diagnosis among neonates in the Neonatal Intensive Care Unit (NICU). It is characterized by an acute inflammatory eruption of the skin in the diaper area.

DETAILS: This study aimed to investigate the effect of colloid oatmeal and colloid cream on diaper rash among preterm neonates in the NICU. This study took place in the NICU of El-Raml Children's Hospital at Wengat in Alexandria, Egypt. Using a randomized control trial pre-posttest design with three parallel groups. Ninety preterm neonates with diaper rash were randomly assigned to three equal groups. Diaper Dermatitis Scale attached with demographic and clinical data was used. The outcome was assessed for four consecutive days for each group. Preterm neonates who received colloid oatmeal had significantly declined in the total mean score of severity of diaper rash in 3rd and 4th days with mean 0.833 ± 1.234 and 0.000 ± 0.000 compared to 2.333 ± 0.844 and 1.500 ± 1.224 in colloid group and 2.566 ± 0.817 and 1.966 ± 1.325 in the control group (p₁ = 0.027 in the 4th day, and p₂ and p₃ < 0.001 for each day).

Copyright © Neonatal Nurses Association. Published by Elsevier Ltd. All rights reserved.

Source: Saleh. S. E., Ismail, E.M., Fathy, H. M. A. E., et al. (2024). The Effect of Colloid Oatmeal Compared to Colloid Cream on Diaper Rash Among Preterm Neonates in the Neonatal Intensive Care Unit. J. Neonatal Nurs.. 2025; 31(1): 135-145. Published: February, 2025. DOI: 10.1016/j.jnn.2024.07.017.

[Posted 3/Mar/2025]

AUDIENCE: Endocrinology, Family Medicine

KEY FINDINGS: The FDA has resolved the shortage of semaglutide injection products, a glucagon-like peptide 1 (GLP-1) medication, meeting US demand, ending a nearly 3-year shortage. Patients and prescribers may still see intermittent and limited localized supply disruptions as the products move through the supply chain from the manufacturer and distributors to local pharmacies.

BACKGROUND: FDA has determined the shortage of semaglutide injection products, a glucagon-like peptide 1 (GLP-1) medication, is resolved. Semaglutide injection products have been in shortage since 2022 due to increased demand.

DETAILS: FDA confirmed with the drug's manufacturer that their stated product availability and manufacturing capacity can meet the present and projected national demand. Patients and prescribers may still see intermittent and limited localized supply disruptions as the products move through the supply chain from the manufacturer and distributors to local pharmacies.

To avoid unnecessary disruption to patient treatment, the agency does not intend to take action against compounders for violations of the FD&C Act arising from conditions that depend on semaglutide injection products’ inclusion on FDA’s drug shortage list:

• For a state-licensed pharmacy or physician compounding under section 503A of the FD&C Act: compounding, distributing or dispensing semaglutide injection products that are essentially a copy of an FDA-approved product within 60 calendar days from today's announcement, until April 22, 2025.
• For outsourcing facilities under section 503B of the FD&C Act: compounding, distributing or dispensing semaglutide injection products that are essentially a copy of an FDA-approved drug product within 90 calendar days from today’s announcement, until May 22, 2025. FDA may still take action regarding violations of any other statutory or regulatory requirements, such as to address findings that a product may be of substandard quality or otherwise unsafe.

Current shortage status of other GLP-1 products (as of February 21, 2025):

FDA continues to actively monitor drug availability and is currently working to determine whether the demand or projected demand for each drug in shortage exceeds the available supply.

• Dulaglutide injection: In shortage. Manufacturer has reported all presentations are available.
• Liraglutide injection: In shortage. Manufacturer has reported two presentations are available, and three have limited availability.

Source: FDA cLarifies Policies for Compounders as National GLP-1 Supply Begins to Stabilize. FDA. Published: February, 21, 2025.

A Case Report

[Posted 11/Feb/2025]

AUDIENCE: Nursing

KEY FINDINGS: This case report describes the use of prone positioning in a pregnant patient. The report offers critical care nurses insights into the clinical management of patients who are pregnant or have intra-abdominal hypertension.

BACKGROUND: Prone ventilation is a standard treatment for acute respiratory distress syndrome, and its clinical benefits are well established. However, implementing prone positioning safely and effectively is challenging in patients who are pregnant, have intra-abdominal hypertension, or are in other high-risk groups.

DETAILS: A patient in the third trimester of pregnancy (28 weeks and 6 days of gestation) developed a body temperature of 39 °C and severe respiratory distress. She was transferred to the intensive care unit, received noninvasive ventilation, and ultimately underwent endotracheal intubation. Because her oxygenation index remained below 100, she received a diagnosis of severe acute respiratory distress syndrome. The patient was safely placed in the prone position with a swim ring while receiving venovenous extracorporeal membrane oxygenation. During this period, her intra-abdominal pressure did not increase significantly. Outcomes: The fetus was delivered by cesarean birth, and the patient was transferred to the general ward after extubation.

Copyright © American Association of Critical-Care Nurses. All rights reserved.

Source: Xu, J., Fu, F., Ding, Q., et al. (2024). Prone Positioning in a Pregnant Woman With Severe Acute Respiratory Distress Syndrome: A Case Report. Crit Care Nurse. 2024; Published: February, 2025. DOI: 10.4037/ccn2025831.