Construct Validity and Inter-Rater Reliability of a Tool Designed for Nurses

[Posted 17/Jan/2023]

AUDIENCE: Nursing

KEY FINDINGS: The surgical wound assessment tool was deemed to be acceptable, valid and reliable for monitoring the status of surgical wound healing. However, further modification and testing are needed to strengthen the tool and to determine the applicability of the tool in other populations.

BACKGROUND: Purpose of this study is to validate construct validity and inter-rater reliability of a surgical wound assessment tool. Wound assessment is central to appropriate wound management. However, limited standard surgical wound assessment tools are available to assist nurses in assessing and recording progress in the healing of surgical wounds.

DETAILS: A prospective observational study was utilised to test the validity and reliability. The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) guideline was used. Convenience sampling was used to recruit 260 patients who underwent elective or emergency surgery at a hospital in Vietnam. Exploratory factor analysis was used to examine the construct validity of the surgical wound assessment tool. Inter-rater reliability was calculated using the intraclass correlation coefficient and Cohen's kappa to determine reliability of the overall scale and identified items. The results of the exploratory factor analysis supported a three-component structure of the surgical wound assessment tool. The intraclass correlation coefficient value of the overall scale was 0.79 (95% CI 0.67-0.89), p < .001, confirming excellent inter-rater reliability. Cohen's kappa value ranged from 0.5 to 1, demonstrating moderate to almost perfect level of agreement for individual items, except for one item on pain.

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

Source: Do, H. T. T., Edwards, H., Finlayson, K. (2023). Surgical Wound Assessment Tool: Construct Validity and Inter-Rater Reliability of a Tool Designed for Nurses. Journal of Clinical Nursing. 2023; 32: 83-95. Published: January, 2023. DOI: 10.1111/jocn.16476.

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.

Primary Results of the PEERLESS Randomized Controlled Trial

[Posted 4/Feb/2025]

AUDIENCE: Cardiology, Emergency Medicine

KEY FINDINGS: PEERLESS met its primary end point in favor of LBMT compared with CDT in treatment of intermediate-risk pulmonary embolism. LBMT had lower rates of clinical deterioration and/or bailout and postprocedural intensive care unit use compared with CDT, with no difference in mortality or bleeding.

BACKGROUND: There are a lack of randomized controlled trial data comparing outcomes of different catheter-based interventions for intermediate-risk pulmonary embolism.

DETAILS: PEERLESS is a prospective, multicenter, randomized controlled trial that enrolled 550 patients with intermediate-risk pulmonary embolism with right ventricular dilatation and additional clinical risk factors randomized 1:1 to treatment with large-bore mechanical thrombectomy (LBMT) or catheter-directed thrombolysis (CDT). The primary end point was a hierarchal win ratio composite of the following (assessed at the sooner of hospital discharge or 7 days after the procedure): (1) all-cause mortality, (2) intracranial hemorrhage, (3) major bleeding, (4) clinical deterioration and/or escalation to bailout, and (5) postprocedural intensive care unit admission and length of stay. Assessments at the 24-hour visit included respiratory rate, modified Medical Research Council dyspnea score, New York Heart Association classification, right ventricle/left ventricle ratio reduction, and right ventricular function. End points through 30 days included total hospital stay, all-cause readmission, and all-cause mortality. The primary end point occurred significantly less frequently with LBMT compared with CDT (win ratio, 5.01 [95% CI, 3.68-6.97]; P<0.001). There were significantly fewer episodes of clinical deterioration and/or bailout (1.8% versus 5.4%; P=0.04) with LBMT compared with CDT and less postprocedural intensive care unit use (P<0.001), including admissions (41.6% versus 98.6%) and stays >24 hours (19.3% versus 64.5%). There were no significant differences in mortality, intracranial hemorrhage, or major bleeding between strategies or in a secondary win ratio end point including the first 4 components (win ratio, 1.34 [95% CI, 0.78-2.35]; P=0.30). At the 24-hour visit, respiratory rate was lower for patients treated with LBMT (18.3±3.3 versus 20.1±5.1; P<0.001), and fewer had moderate to severe modified Medical Research Council dyspnea scores (13.5% versus 26.4%; P<0.001), New York Heart Association classifications (16.3% versus 27.4%; P=0.002), and right ventricular dysfunction (42.1% versus 57.9%; P=0.004). Right ventricle/left ventricle ratio reduction was similar (0.32±0.24 versus 0.30±0.26; P=0.55). Patients treated with LBMT had shorter total hospital stays (4.5±2.8 overnights versus 5.3±3.9 overnights; P=0.002) and fewer all-cause readmissions (3.2% versus 7.9%; P=0.03), whereas 30-day mortality was similar (0.4% versus 0.8%; P=0.62).

Copyright © American Heart Association, Inc. All rights reserved.

Source: Jaber, W. A., Gonsalves, C. F., Stortecky, S., et al. (2024). Large-Bore Mechanical Thrombectomy Versus Catheter-Directed Thrombolysis in the Management of Intermediate-Risk Pulmonary Embolism: Primary Results of the PEERLESS Randomized Controlled Trial. Circulation. 2025; 151(5). Published: February 4, 2025. DOI: 10.1161/CIRCULATIONAHA.124.07236.

[Posted 31/Dec/2024]

AUDIENCE: Nursing

KEY FINDINGS: Nursing staff interventions regarding shock team activation significantly improved the time of diagnosis and acceptance of patients with cardiogenic shock in a cardiovascular hospital, enhancing the overall quality of care provided to these patients.

BACKGROUND: Patients with cardiogenic shock have a 25% to 50% mortality rate despite the introduction of mechanical circulatory devices and coordinated medical treatment. The use of shock teams has improved outcomes for these patients.

DETAILS: A cardiovascular hospital with a multidisciplinary shock team had inconsistency and delays in recognition and diagnosis of patients with cardiogenic shock. A nurse-led, preintervention-postintervention quality improvement project was performed in April and May 2021 and in April and May 2022 within a cardiovascular hospital in north Texas. The 2 nursing staff interventions regarding shock team activation were education and shock alert implementation. Time from first signs to diagnosis (for inpatients) and time from initial transfer request to acceptance (for transferring patients) were measured. Descriptive and statistical analyses were conducted using R, version 4.0.0 (R Foundation for Statistical Computing). The mean (SD) time to diagnosis of cardiogenic shock decreased significantly from 17.98 (28.39) hours in the preintervention group (n = 25) to 8.15 (12.26) hours in the postintervention group (n = 45; P = .045). For patients with cardiogenic shock transferring from referring hospitals, the median (IQR) time to acceptance was 1.55 (0.08-3.18) hours in the preintervention group and 0.35 (0.00-0.72) hours in the postintervention group (P < .001).

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

Source: Krais, S., Sheasby, J., Banwait, J., et al. (2024). Improving Cardiogenic Shock Team Activation Through Nurse Education and Alert Implementation. Crit Care Nurse. 2024; 44(6): 24–30. Published: October, 2024. DOI: 10.4037/ccn2024259.

The YAWNS NB Randomized Clinical Trial

[Posted 30/Dec/2024]

AUDIENCE: Psychiatry, Family Medicine

KEY FINDINGS: Results of the YAWNS NB randomized clinical trial show that, as a simple, scalable, direct-to-patient intervention, YAWNS-1 substantially reduced BZRA use and improved sleep outcomes. It could be implemented to transform insomnia care for older adults at the population level.

BACKGROUND: Direct-to-patient interventions enabling transitions from long-term benzodiazepine receptor agonist (BZRA) use to cognitive behavioral therapy for insomnia (CBTI) by older adults has the potential to reduce BZRA use and related harms while improving sleep outcomes without requiring prearranged clinician involvement. Aim of this study was to compare 2 direct-to-patient behavior change interventions with treatment as usual (TAU) on BZRA use, sleep, and other health outcomes, and uptake of CBTI techniques.

DETAILS: The Your Answers When Needing Sleep in New Brunswick (YAWNS NB) study was a 3-arm, pragmatic, open-label, minimum-contact, randomized clinical trial. The study began November 2020 and ended June 2022. Participants were randomly allocated to 1 of 3 groups, including 2 different mailed behavior change interventions or no intervention (TAU). Participants were from communities across the province of New Brunswick, Canada, and included adults 65 years and older living independently with long-term use of BZRAs and current or past insomnia. The Sleepwell package (YAWNS-1) consisted of a cover letter and 2 booklets (“How to Stop Sleeping Pills” and “How to Get Your Sleep Back”). The other package (YAWNS-2) included updated versions of the 2 booklets (“You May Be at Risk” and “How to Get a Good Night’s Sleep Without Medication”) used in the Eliminating Medications Through Patient Ownership of End Results (EMPOWER) study. Main outcomes and measures: BZRA use at 6 months was the primary measure. Secondary measures included CBTI use, sleep, insomnia, daytime sleepiness, safety, anxiety, frailty, and quality of life.

A total of 1295 individuals expressed interest in the study, and 565 (43.6%) completed a baseline assessment. Participants had a mean (SD) age of 72.1 (5.7) years, a mean (SD) BZRA use duration of 11.4 (9.1) years, and 362 (64.1%) were female. Discontinuations and dose reductions of 25% or greater were highest with YAWNS-1 (50 of 191 [26.2%]; 39 of 191 [20.4%]; total, 46.6%) compared with YAWNS-2 (38 of 187 [20.3%]; 27 of 187 [14.4%]; total, 34.8%, P = .02) and TAU (14 of 187 [7.5%]; 24 of 187 [12.8%]; total, 20.3%, P < .001). YAWNS-1 also demonstrated better uptake of CBTI techniques and sleep outcomes compared with YAWNS-2 (new CBTI techniques: 3.1 vs 2.4; P =.03; sleep efficiency change: 4.1% vs -1.7%; P =.001) and reduced insomnia severity and daytime sleepiness compared with TAU (insomnia severity index change: -2.0 vs 0.3; P <.001; Epworth Sleepiness Scale change: -0.8 vs 0.3; P =.001).

Copyright © American Medical Association. All Rights Reserved.

Source: Gardner, D. M., Turner, J. P., Magalhaes, S., et al. (2024). Patient Self-Guided Interventions to Reduce Sedative Use and Improve Sleep: The YAWNS NB Randomized Clinical Trial. JAMA Psychiatry. 2024; 81(12): 1187-1197. Published: December, 2024. DOI: 10.1001/jamapsychiatry.2024.2731.

[Posted 26/Nov/2024]

AUDIENCE: Cardiology, Emergency Medicine

ACTION: The U.S. Food and Drug Administration has approved Attruby (acoramidis) to treat adults with cardiomyopathy (disorder that affects heart muscle) of wild-type or variant (hereditary) transthyretin-mediated amyloidosis (ATTR-CM) to reduce death and hospitalization related to heart problems.

Attruby is taken orally, twice daily. Recommended dosing is available in the prescribing information.

DISEASE OR CONDITION: ATTR-CM is a rare and serious disease that affects the heart muscle. In patients with ATTR-CM, there is a build-up of protein deposits in the heart, causing the walls of the heart to become stiff, and making the left ventricle unable to properly relax and fill with blood (called cardiomyopathy). As the condition progresses, the heart can become unable to pump blood out adequately, causing heart failure.

There are two types of ATTR-CM, hereditary ATTR-CM (hATTR-CM) and wild-type ATTR-CM (wATTR-CM). In hATTR-CM, which can run in families, there’s a variant in the transthyretin gene, which results in protein deposits in the heart. In wATTR-CM, there is no variant in the transthyretin gene.

While the true prevalence of ATTR-CM is unknown, increasing awareness and enhanced diagnostic tools have led to increasing estimates of the number of patients with ATTR-CM.

EFFECTIVENESS: The efficacy and safety of Attruby were evaluated in a multicenter, international, randomized, double-blind, placebo-controlled study in 611 adult patients with wild-type or hereditary (variant) ATTR-CM (NCT03860935).

The primary endpoint of the study included all-cause mortality and cumulative frequency of cardiovascular-related hospitalizations (CVH) over 30 months. At 30 months, more patients taking Attruby vs placebo were alive (81% vs 74%) and there were fewer CVH in those taking Attruby vs placebo (mean number of 0.3 vs 0.6 per year).

SAFETY INFORMATION: The most common adverse reactions were diarrhea and upper abdominal pain. Most of these gastrointestinal adverse reactions were categorized as mild and resolved without drug discontinuation.

DESIGNATIONS: Attruby received orphan drug designation for this indication.

Source: FDA Approves Drug for Heart Disorder Caused by Transthyretin-Mediated Amyloidosis. FDA. Published: November 25, 2024.