Standard Care Group Research Articles

Effect of an oral stimulation protocol on breastfeeding among preterm infants: a randomised controlled trial

ObjectivesThe objectives are to assess the effectiveness of a modified and adapted oral sensorimotor intervention (MA-OSMI) protocol for infants in India on the rate and performance of breastfeeding among preterm...

Tenofovir and Hepatitis B Virus Transmission During Pregnancy: A Randomized Clinical Trial.

Standard care for preventing mother-to-child transmission (MTCT) of hepatitis B virus (HBV) in highly viremic mothers consists of maternal antiviral prophylaxis beginning at gestational week 28 combined with an HBV vaccine series and HBV immune globulin (HBIG) at birth. However, HBIG is unavailable in some resource-limited areas. To determine whether initiating tenofovir disoproxil fumarate (TDF) at gestational week 16 combined with HBV vaccinations for infants is noninferior to the standard care of TDF at gestational week 28 combined with HBV vaccinations and HBIG for infants in preventing MTCT in mothers with HBV and high levels of viremia. An unblinded, 2-group, randomized, noninferiority clinical trial was conducted in 7 tertiary care hospitals in China. A total of 280 pregnant individuals (who all identified as women) with HBV DNA levels greater than 200 000 IU/mL were enrolled between June 4, 2018, and February 8, 2021. The final follow-up occurred on March 1, 2022. Pregnant individuals were randomly assigned to receive either TDF starting at gestational week 16 with HBV vaccinations for the infant or TDF starting at gestational week 28 with HBV vaccinations and HBIG administered to the infant. The primary outcome was the MTCT rate, defined as detectable HBV DNA greater than 20 IU/mL or hepatitis B surface antigen positivity in infants at age 28 weeks. Noninferiority was established if the MTCT rate in the experimental group did not increase by more than an absolute difference of 3% compared with the standard care group, as measured by the upper limit of the 2-sided 90% CI. Among 280 pregnant individuals who enrolled in the trial (mean age, 28 years; mean gestational age at enrollment, 16 weeks), 265 (95%) completed the study. Among all live-born infants, using the last observation carried forward, the MTCT rate was 0.76% (1/131) in the experimental group and 0% (0/142) in the standard care group. In the per-protocol analysis, the MTCT rate was 0% (0/124) in the experimental group and 0% (0/141) in the standard care group. The between-group difference was 0.76% (upper limit of the 2-sided 90% CI, 1.74%) in all live-born infants and 0% (upper limit of the 2-sided 90% CI, 1.43%) in the per-protocol analysis. Both comparisons met the criterion for noninferiority. Rates of congenital defects and malformations were 2.3% (3/131) in the experimental group and 6.3% (9/142) in the standard care group (difference, 4% [2-sided 95% CI, -8.8% to 0.7%]). Among pregnant women with HBV and high levels of viremia, TDF beginning at gestational week 16 combined with HBV vaccination for infants was noninferior to the standard care of TDF beginning at gestational week 28 combined with HBIG and HBV vaccination for infants. These results support beginning TDF at gestational week 16 combined with infant HBV vaccine to prevent MTCT of HBV in geographic areas where HBIG is not available. ClinicalTrials.gov Identifier: NCT03476083.

TEC-ADHERE: Real-World Persistence and Adherence on Dimethyl Fumarate in Patients with Relapsing-Remitting Multiple Sclerosis in the French OroSEP Patient-Support Program.

Treatment persistence and adherence are essential for achieving therapeutic goals in patients with multiple sclerosis (MS). OroSEP is an independent patient-support program (PSP) in France for patients with relapsing-remitting MS (RRMS) receiving oral disease-modifying therapies. TEC-ADHERE (NCT04221191; 08/19/2019-09/15/2022) was a prospective, non-interventional, phase4 study to assess the effect of OroSEP on persistence and adherence to dimethyl fumarate (DMF; Tecfidera™) in patients with RRMS. Outcomes were compared for patients in OroSEP versus non-OroSEP patients who received their neurologists' standard of care (SoC). Patients initiated DMF at month0 (M0); follow-up visits occurred at M3 and M6. Primary outcome was persistence at M6. Secondary outcomes included persistence at M1 and M3, adherence at M6 (Girerd questionnaire), anxiety (Generalized Anxiety Disorder Assessment), patient satisfaction at M6 (Treatment Satisfaction Questionnaire for Medication), patient and neurologist satisfaction with OroSEP participation, and adverse events (AEs). Per-protocol population included 341 patients (OroSEP, n = 135; SoC, n = 206). Persistence was similar for OroSEP vs SoC (M6, 75.9% vs 76.6%; M1, 96.0% vs 92.4%; M3, 85.5% vs 89.0%). At M6, mean adherence was higher for OroSEP (5.4) vs SoC (4.7; p < 0.0001), and good adherence (Girerd score = 6) was achieved by more OroSEP patients (55.7%) than SoC patients (29.6%; p < 0.01). Mean anxiety scores were lower in the OroSEP group than in the SoC group at baseline (7.1 vs 8.8; p = 0.02) and M6 (3.4 vs 6.1; p < 0.001). Mean satisfaction scores at M6 were higher for OroSEP (77.4) vs SoC (64.2; p < 0.01). Most neurologists (n = 11/14) agreed that OroSEP helped improve adherence. Treatment-related AEs occurred in 62 (36.3%) OroSEP patients and 76 (42.9%) SoC patients; most common were flushing, diarrhea, hot flush, and abdominal pain. These outcomes support the value of PSPs in encouraging adherence, alleviating anxiety, improving patient satisfaction, and supporting patients to be more independent in managing MS. ClinicalTrials.gov identifier, NCT04221191.

CTNI-01. INTERVENTION OUTCOMES OF ENHANCED RECOVERY AFTER SURGERY PROTOCOL VERSUS STANDARD CARE FOR GLIOMA PATIENTS IN SELECTED HOSPITALS IN DEMOCRATIC REPUBLIC OF THE CONGO: RANDOMIZATION AND STRATIFICATION OF PROVIDERS AND HOSPITALS

Abstract BACKGROUND Enhanced Recovery after Surgery (ERAS) protocols have shown promise in improving perioperative care and patient outcomes in various surgical specialties. Aim: This study will aim to assess the efficacy of ERAS compared to the current standard of care (SOC) for glioma patients in DRC hospitals. METHODS A pragmatic, multicenter, randomized controlled trial will be designed to evaluate the outcomes of glioma patients treated with ERAS protocols versus SOC in selected hospitals in DRC. EXPECTED RESULTS A total of 100 glioma patients will be included in this study, with 50 patients in the ERAS group and 50 in the SOC group. The primary analysis will reveal that the ERAS group will have significantly fewer post-operative complications (p &amp;lt; 0.05) and a shorter length of hospital stay (p &amp;lt; 0.05) compare to the SOC group. Patient satisfaction scores will also higher in the ERAS group. Subgroup analyses by hospital center will indicate consistent trends in favor of the ERAS protocol. Randomization of providers and stratification by hospital will aim to mitigate the influence of individual provider practices and hospital-specific factors on the study outcomes. This approach will be expected to enhance the validity of the results and ensure equitable representation across hospitals. CONCLUSIONS The unique design of randomizing providers and stratifying by hospital will be a critical component of this multicenter trial, which seeks to provide valuable insights into the potential benefits of ERAS protocols for glioma patients in DRC. The findings will guide clinical practice and healthcare policy in resource-constrained settings, ultimately improving the care and outcomes of glioma patients

Alteplase in COVID-19 severe hypoxemic respiratory failure: the TRISTARDS multicenter randomized trial

BackgroundPulmonary intravascular thrombus formation has been widely observed in patients with respiratory failure, for example, in patients with SARS-CoV-2 infection (COVID-19). The aim of this study was to evaluate the efficacy/safety of alteplase thrombolysis in COVID-19 severe hypoxemic respiratory failure. In this multicenter, open-label study, patients were randomized to receive alteplase (low- or high-dose) over 5 days plus standard of care (SOC), or SOC alone. The primary endpoint was time to clinical improvement (≥ 2-point decrease on WHO Clinical Progression Scale, or hospital discharge) up to Day 28. Secondary endpoints included all-cause mortality at Day 28, treatment failure at Day 28 and change in arterial oxygen partial pressure/fractional inspired oxygen (PaO2/FiO2) ratio at Day 6 versus baseline.ResultsSixty-nine patients were randomized to alteplase (low- or high-dose) and 35 to SOC; 65% were on high-flow oxygen or non-invasive ventilation at baseline. Median time to clinical improvement was 25 days in the alteplase group and > 28 days (median not reached) in the SOC group. All-cause mortality was 8/69 (12%) versus 10/35 (29%) in the alteplase versus SOC groups, respectively (unadjusted risk difference [RD], − 17% [95% confidence interval (CI) − 34 to 0], p = 0.047; adjusted RD, − 16% [95% CI − 31 to 1], p = 0.058). The PaO2/FiO2 ratio (mean [standard deviation]) increased by + 30 (84) mmHg in the alteplase group and decreased by − 12 (59) mmHg in the SOC group (adjusted mean difference vs. SOC, p = 0.052). Differences were greater in patients receiving high-dose alteplase, and in those not receiving invasive ventilation. Eighteen patients (26.1%) in the alteplase group discontinued treatment due to adverse events. Major bleeding was more frequent with alteplase than with SOC (9 vs. 0 patients); no bleeding was fatal. The study closed early due to insufficient patient recruitment.ConclusionAlteplase was not associated with faster clinical recovery from COVID-19 severe hypoxemic respiratory failure. A numerical difference in survival and PaO2/FiO2 ratio was observed, particularly in patients not receiving invasive ventilation. These exploratory findings merit further investigation in larger patient cohorts that are adequately powered to confirm the hypotheses generated in this study regarding the impact of alteplase on treatment outcomes.Trial registration ClinicalTrials.gov: NCT04640194 (November 23, 2020); https://clinicaltrials.gov/study/NCT04640194 (early discontinuation due to insufficient patient recruitment).

Telemedicine for long-term continuous positive airway pressure therapy: A six-month follow-up study in Japan using propensity score matching

BackgroundDuring the coronavirus disease (COVID-19) pandemic, Japan's health insurance system allowed continuous positive airway pressure (CPAP) telephone consultations to extend clinic visit intervals. This study aimed to determine whether 6-month CPAP adherence in the telemedicine (TM) group was inferior to that in the standard care group. MethodsPatients receiving long-term CPAP therapy for at least 6 months for obstructive sleep apnea (OSA) from two clinics in Japan were recruited between May and July 2020. The TM group consisted of patients who had not visited the clinic in person for 6 months, with physicians providing telephone consultations every 1–2 months. The standard care group included patients who visited the clinic monthly for physician consultation. In both groups, physicians reviewed CPAP usage data via telemonitoring. Patients were classified into three groups according to change in adherence: ≤ −5%, > −5 to <5%, and ≥5%. The primary outcome was the number of patients with worsened CPAP adherence (≤−5%). ResultsOf the 479 patients in the TM group and 146 in the standard care group, 120 were matched using propensity score 1:1 nearest neighbor matching and selected from both groups. Adherence worsened in 41 (34.2%) and 32 (26.7 %) patients in the TM and standard care groups, respectively. The TM group was not inferior to the standard care group in terms of the proportion of patients with worsened CPAP adherence (χ2 = 1.81, df = 1, P = 0.178). ConclusionsThis study found no significant difference in the 6-month CPAP adherence between the TM and standard care groups.

Automated oxygen administration versus manual control in acute cardiovascular care: a randomised controlled trial.

Oxygen therapy is commonly administered to patients with acute cardiovascular conditions during hospitalisation. Both hypoxaemia and hyperoxia can cause harm, making it essential to maintain oxygen saturation (SpO2) within a target range. Traditionally, oxygen administration is manually controlled by nursing staff, guided by intermittent pulse oximetry readings. This study aimed to compare standard manual oxygen administration with automated oxygen administration (AOA) using the O2matic device. In this randomised controlled trial, 60 patients admitted to a cardiac department with an acute cardiovascular condition requiring oxygen therapy were randomised to either standard care (manual oxygen administration) or AOA via the O2matic device. The primary outcome was the percentage of time spent within the desired SpO2 range (92%-96% or 94%-98%) over 24 hours. Patients had a mean age of 75.8±12.4 years, with an average SpO2 of 93%. Those in the AOA group (n=25) spent significantly more time within the target SpO2 range (median 87.0% vs 60.6%, p<0.001) compared with the standard care group (n=28). Time spent below the desired SpO2 range was significantly lower in the AOA group (7.9% vs 33.6%, p<0.001). No significant differences in time spent above the desired SpO2 range were observed between the two groups. AOA with the O2matic device is superior to standard manual control in maintaining SpO2 within the target range in patients hospitalised with acute cardiovascular conditions. The automated systems significantly reduce the time spent in hypoxaemia without increasing hyperoxia. NCT05452863.

Effect of early mobilization on functional recovery in ICU patients with post-COVID ARDS

Background. The COVID-19 pandemic has significantly increased the number of patients requiring intensive care unit (ICU) admissions due to severe complications such as acute respiratory distress syndrome (ARDS). Prolonged ICU stays, often associated with immobility, lead to muscle weakness, ICU-acquired weakness (ICU-AW), and reduced functional status, which impede recovery. Early mobilization in the ICU has been proposed as a beneficial intervention to mitigate these effects, but its impact on patients with post-COVID ARDS remains underexplored. Objective. This study aimed to evaluate the effect of early mobilization on functional recovery in ICU patients with post-COVID ARDS. Methods. A prospective, randomized controlled trial was conducted at Saveetha Medical College and Hospital, Chennai, from August 2021 to August 2024. Two hundred patients with post-COVID ARDS were randomly assigned to either an early mobilization or standard care group. The early mobilization group received structured physical therapy interventions within 48 hours of ICU admission. Functional status was measured using the ICU Mobility Scale (IMS) and Functional Status Scale ICU (FSS ICU) at baseline, weekly, and discharge. Secondary outcomes included the duration of ICU stay, mechanical ventilation, and incidence of ICU-AW. Results. Patients in the early mobilization group demonstrated significantly higher functional recovery, with a mean IMS score of 7.8 ± 1.2 compared to 4.3 ± 1.5 in the standard care group (p &lt; 0.001). The FSS ICU score was also significantly higher in the early mobilization group (90.6 ± 8.3) than in the standard care group (65.4 ± 10.7; p &lt; 0.001). Additionally, early mobilization reduced the mean ICU stay (14.5 ± 3.2 vs. 19.8 ± 4.1 days, p &lt; 0.001), shortened the duration of mechanical ventilation (10.1 ± 2.9 vs. 13.7 ± 3.6 days, p &lt; 0.001), and decreased the incidence of ICU-AW (20% vs. 45%, p = 0.002). Conclusion. Early mobilization significantly improves functional recovery, reduces ICU stay and mechanical ventilation duration, and lowers ICU-AW risk in post-COVID ARDS patients. These findings highlight the importance of integrating early mobility into standard ICU care to enhance patient outcomes.

Treated obstructive sleep apnoea and incident arrhythmias

Abstract Background Obstructive sleep apnoea (OSA) is prevalent in approximately 15% of western populations. Cardiovascular disease and arrhythmia are extremely common in this group with significant morbidity overlap. Whilst treatment of OSA with continuous positive airways pressure (CPAP) appears to reduce hypertension, bradycardia and recurrence of atrial fibrillation (AF), large randomised control trials and meta-analyses do not demonstrate a significant reduction of incident tachyarrhythmias such as atrial fibrillation or sudden cardiac death. Some smaller studies suggest that AF may have up to 20% incidence. Analysis of these studies suggest that there may be significant heterogeneity in both CPAP usage and OSA phenotype, confounding the results. Furthermore, standard arrhythmia detection often underestimates paroxysmal arrhythmias. This on-going trial investigates a treated OSA population using CPAP monitoring and implantable loop recorders (ILR). Purpose This study aims to identify the incidence of arrhythmia in a treated OSA population with comprehensive arrhythmia monitoring and CPAP usage. It also explores the mechanisms linking OSA and arrhythmia such as heart rate variability and turbulence and cardiac biomarkers in order to identify at risk sub populations. Methods Continuous moderate-to-severe OSA patients were recruited from a major UK sleep centre after ECG and medical history confirmed the absence of arrhythmia. Each patient was then randomised to receive either standard-care or standard-care with an ILR with 24-hour heart rate variability/turbulence measurements, echocardiography (where possible) and cardiac biomarkers at baseline and 12 months. All patients had remote CPAP usage monitoring (where possible). The trial ended at 36 months after enrolment. Results 200 patients were recruited to the trial. Current mean average follow-up is 28 months in this on-going trial. Mean age and apnoea hypopnea index at enrolment was 53 years and 43.8 respectively. To date we have diagnosed atrial fibrillation in 15% of the ILR group compared to 2% in the standard care group. Other arrhythmias detected in the ILR group include two with supraventricular tachycardia and 2 with significant pauses but not requiring further treatment. Final analysis of arrhythmia incidence with CPAP usage and heart rate variability/turbulence, and cardiac biomarkers is ongoing with final results due by the time of final submission. Conclusion Arrhythmias, particularly AF, are highly incident in OSA despite CPAP treatment. This study may determine if heterogenous CPAP usage confounds the above observation and whether there may be predictors of arrhythmia that may indicate a need for arrhythmia screening in the OSA population.

Midwifery Continuity of Care During Pregnancy, Birth, and the Postpartum Period: A Matched Cohort Study.

To compare pregnancy outcomes in a midwifery continuity of care (MCoC) model to standard midwifery care in Sweden. Matched cohort study. Public healthcare during pregnancy and childbirth, Stockholm, Sweden. Women giving birth at Karolinska University Hospital site Huddinge in Stockholm between January 1, 2019, and August 31, 2021. Data on all births including MCoC and standard care, during the time period, were retrieved from the national Swedish Pregnancy Register. Propensity score matching was applied to obtain a matched set from the standard care group for every woman in the MCoC model. Based on the matched cohort, we estimated risk ratios (RR) for binary outcomes with 95% confidence intervals (CI). Interventions during labor, mode of birth, and preterm birth (< 37 gestational weeks). Compared with standard care, women in the MCoC model were more likely to give birth spontaneously (RR 1.06 95% CI 1.02-1.10) and less likely to have an elective cesarean on maternal request (RR 0.24 95% CI 0.11-0.51). The risk of preterm birth was also reduced in the MCoC group (RR 0.51 95% CI 0.32-0.82). The MCoC model was associated with fewer medical interventions and improved pregnancy outcomes.

Microaxial Flow Pump Hemodynamic and Metabolic Effects in Infarct-Related Cardiogenic Shock

Mechanical circulatory support with a microaxial flow pump (MAFP) has been shown to improve survival in ST-elevation myocardial infarction-induced cardiogenic shock (STEMI-CS). Understanding the impact on hemodynamic stability over time is crucial for optimizing patient treatment. To determine if an MAFP reduces the need for pharmacological circulatory support without compromising hemodynamics compared with standard care in STEMI-CS. This was a substudy of the Danish-German (DanGer) Shock trial, an international, multicenter, open-label randomized clinical trial. Patients from 14 heart centers across Denmark, Germany, and the UK were enrolled. Inclusion criteria for the trial were STEMI and systolic blood pressure less than 100 mm Hg or ongoing vasopressor treatment, left ventricular ejection fraction less than 45%, and arterial lactate level greater than 2.5 mmol/L. Of the enrolled patients, after exclusions from death in the catheterization laboratory or immediately on intensive care unit (ICU) admission, the remaining patients had serial recordings of hemodynamics, arterial lactate, and use of vasoactive drugs. Patients who were in comas after cardiac arrest and patients with mechanical complications or right ventricular failure were excluded. Data were analyzed from May to September 2024. MAFP and standard of care or standard of care alone. Hemodynamic status in terms of heart rate and blood pressure, metabolic status in terms of arterial lactate concentration, and vasoactive-inotropic score (VIS). The clinical events during the first 72 hours were as follows: death from all causes, escalation of mechanical circulatory support, and discharge alive from the ICU. From 355 enrolled patients, 324 (mean [IQR] age, 68 [58-75] years; 259 male [80%]) underwent ICU treatment (169 [52%] in the MAFP group, 155 [48%] in the standard-care group). Baseline characteristics were balanced. There was no difference in heart rate between groups, and mean arterial pressure was above the treatment target of 65 mm Hg in both groups but was achieved with a lower VIS in the MAFP group. No difference in arterial lactate level was found between groups at randomization, but on arrival to the ICU, the MAFP group had significantly lower arterial lactate levels compared with the standard-care group (mean difference, 1.3 mmol/L; 95% CI, 0.7-1.9 mmol/L), a difference that persisted throughout the first 24 hours of observation. The MAFP group achieved lactate normalization (<2 mmol/L) 12 hours (95% CI, 5-18 hours) before the standard-care group. Use of a MAFP reduces the use of vasopressors and inotropic medication while maintaining hemodynamic stability and achieving faster normalization of lactate level in patients with STEMI-CS. ClinicalTrials.gov Identifier: NCT01633502.

Empagliflozin as a novel therapy for cirrhotic refractory ascites: a randomized controlled study

BackgroundCirrhotic refractory ascites (RA) patients have few alternatives for treatment. Empagliflozin is now known to have natriuretic and neurohormonal modulatory effects. This research investigated the safety and efficacy of empagliflozin in the management of RA when added to the standard of care (SoC) compared to SoC alone.MethodsPatients were randomized to receive either a fixed dose of 10 mg of empagliflozin plus standard of care (SoC) or SoC alone. Patients were followed up for 3 months. The primary endpoint was achieving no need for large-volume paracentesis (LVP).ResultsForty-two patients were randomized equally, and intention-to-treat was performed. There was a statistically significant decrease in the need for LVP in the empagliflozin group compared to the SoC group (100% in the SoC vs. 42.9% in the empagliflozin group, p < 0.001). By the end of the study, the total resolution of ascites was reported in approximately 24% of patients. Muscle cramps and newly developed hyponatremia were more common in the empagliflozin group, but they were mild. Acute kidney injury was more common in the SoC group.ConclusionsEmpagliflozin may be an effective option for use as an add-on therapy in the management of RA, with an accepted safety profile.Trial registrationThe trial was registered at www.clinicaltrials.gov under the identifier NCT05430243. The registration was submitted on 18/06/2022. It is available at https://clinicaltrials.gov/study/NCT05430243.Graphical

Neuropsychological outcomes following endovascular clot retrieval and intravenous thrombolysis in ischemic stroke.

Cognitive impairment, anxiety, depression, fatigue, and dependence in instrumental activities of daily living (ADL) are common after stroke; however, little is known about how these outcomes may differ following treatment with endovascular clot retrieval (ECR), intravenous tissue plasminogen activator (t-PA), or conservative management. Patients were recruited after acute treatment and invited to participate in an outcome assessment 90-120 days post-stroke. The assessment included a cognitive test battery and several questionnaires. The COVID-19 pandemic led to significant disruptions in recruitment and data collection, and the t-PA and conservative management groups were combined into a standard medical care (SMC) group. Sixty-two participants were included in the study (ECR = 31, SMC = 31). Mean age was 66.5 (20-86) years, and 35 (56.5%) participants were male. Participants treated with ECR had significantly higher National Institutes of Health Stroke Scale scores at presentation and significantly lower education. After adjusting for stroke severity, premorbid intellectual ability, and age, treatment with ECR was associated with significantly better performances on measures of cognitive screening, visual working memory, and verbal learning and memory. Participants treated with ECR also experienced less fatigue and were more likely to achieve independence in basic and instrumental ADLs. Despite this, cognitive impairment and fatigue were still common among participants treated with ECR and anxiety and depression symptoms were experienced similarly by both groups. Cognitive impairment and fatigue were less common but still prevalent following treatment with ECR. This has important practical implications for stroke rehabilitation, and routine assessment of cognition, emotion, and fatigue is recommended for all stroke survivors regardless of stroke treatment and functional outcome.

Virtual reality for the management of pain and anxiety during outpatient manual vacuum aspiration for miscarriage or incomplete abortion: a mixed methods trial.

To evaluate the efficacy and acceptability of virtual reality (VR) as a distraction technique in the management of acute pain and anxiety during outpatient uterine aspiration using a manual vacuum aspirator (MVA). This mixed methods study included a prospective multi-centre randomised controlled trial and structured individual interviews. Of the 72 patients approached, 50 consenting, eligible participants were randomised to VR intervention (immersive video content 'The Forest of Serenity') or standard care during MVA for the management of miscarriage or incomplete abortion from July 2021-July 2022 across two university hospitals in London, UK. Expected and actual pain scores, and anxiety before and after the procedure were measured as numeric rating scores (0-10). Structured interviews were undertaken after the procedure in women randomised to VR. Statistical analysis of pain and anxiety scores were by intention-to-treat including all randomised participants, using Stata-12 software. Qualitative analysis was achieved by thematic analysis of transcribed interviews. There was no significant difference in pain or anxiety scores reported by participants randomised to VR compared with standard care. Mean worst pain scores were 5.98 and 6.88 in the standard care and VR groups respectively (p-value 0.13), with corresponding anxiety scores at the end of the procedure 3.94 and 3.3 (p-value 0.57). Qualitative analysis from interviews was highly favourable from women randomised to VR with all participants reporting a positive experience. 90% (18/20) of participants reported that VR reduced their anxiety and 71% (15/21) stated that it helped to reduce or distract from their pain. While virtual reality did not decrease pain or anxiety scores during MVA, it is a feasible and acceptable option that may improve patient experience. Randomisation to VR during MVA did not reduce pain or anxiety scores. However, at structured interview most participants reported that VR reduced their anxiety and reduced or distracted them from their pain. VR is a feasible and acceptable option that may improve patient experience during MVA.

The Impact of Infliximab on Hyperinflammation State in Hospitalized COVID-19 Patients: A Retrospective Study

Background and Objectives: Elevated levels of pro-inflammatory cytokines have been linked to increased mortality in COVID-19 patients. Infliximab, a tumor necrosis factor inhibitor, has been reported to improve outcomes in COVID-19 patients by targeting the hyperinflammatory response. Our objective was to evaluate the effectiveness of incorporating Infliximab into standard care guidelines for the management of COVID-19. Materials and Methods: A retrospective analysis was conducted on 111 participants who were moderate to severe COVID-19 patients admitted to the hospital. Among them, 74 individuals received solely standard treatment, while 37 received standard therapy plus Infliximab. The primary outcomes of the study centered around the changes in laboratory test parameters. The secondary clinical findings included clinical recovery defined as improvement in patient oxygenation, time till recovery, and assessing necessity for ICU admission, and mortality rates. Results: There was no statistical difference observed in the inflammatory markers including, LDH, Ferritin, CRP, neutrophil to lymphocyte ratio (NLR), and P/F ratio between both groups and in the clinical outcomes including clinical recovery (p = 1.0), time to improvement (p = 0.436), and mortality rate (p = 0.601). However, there was a significant increase in secondary infection (45.9%, 20.3%; p = 0.005), and in liver enzymes, ALT (79.5, 50.0 IU/L; p = 0.02) and AST (57.5, 38.0 IU/L; p = 0.019) in the Infliximab group and the standard care group, respectively. Conclusions: Infliximab therapy did not demonstrate significant benefits compared to standard of care in moderate to severe hospitalized COVID-19 patients.

Extracorporeal Blood Purification and Acute Kidney Injury in Cardiac Surgery

Cardiac surgery-associated acute kidney injury (CSA-AKI) remains a significant problem following cardiopulmonary bypass (CPB). Various strategies are proposed to attenuate CSA-AKI, including extracorporeal blood purification (EBP), but little is known about the effect of EBP through an acrylonitrile-sodium methallylsulfonate/polyethyleneimine membrane during CPB. To determine whether the use of an EBP device in a nonemergent cardiac surgery population reduces CSA-AKI after CPB. This double-blind, randomized clinical trial was conducted in 2 tertiary hospitals in Spain. Patients 18 years or older undergoing nonemergent cardiac surgery who were at high risk for CSA-AKI were enrolled from June 15, 2016, through November 5, 2021, with follow-up data through February 5, 2022. Of 1156 patients assessed, 343 patients were randomized (1:1) to either receive EBP or standard care. Nonselective EBP device connected to the CPB circuit. The primary outcome was the rate of CSA-AKI in the 7 days after randomization. Among 343 patients randomized (169 to receive EBP and 174 to receive usual care), the mean (SD) age was 69 (9) years and 119 were females. The rate of CSA-AKI was 28.4% (95% CI, 21.7%-35.8%) in the EBP group vs 39.7% (95% CI, 32.3%-47.3%) in the standard care group (P = .03), with an adjusted difference of 10.4% (95% CI, 2.3%-18.5%) using a log-binomial model (P = .01). No significant differences (P > .05) were observed in most of the predefined clinical secondary end points or post hoc exploratory end points. In a sensitivity analysis, EBP was found to be more effective in terms of CSA-AKI reduction in patients with chronic kidney disease, diabetes, hypertension, low left ventricular ejection fraction (<40%), and lower body mass index (<30). No differences were observed between the groups in adverse events tracking. The use of a nonselective EBP device connected to the CPB circuit in a nonemergent population of patients undergoing cardiac surgery was associated with a significant reduction of CSA-AKI in the first 7 days after surgery. ClinicalTrials.gov Identifier: NCT02518087.

Cost-effectiveness of a patient-reported outcome-based remote monitoring and alert intervention for early detection of critical recovery after joint replacement: A randomised controlled trial.

While the effectiveness of patient-reported outcome measures (PROMs) as an intervention to impact patient pathways has been established for cancer care, it is unknown for other indications. We assessed the cost-effectiveness of a PROM-based monitoring and alert intervention for early detection of critical recovery paths following hip and knee replacement. The cost-effectiveness analysis (CEA) is based on a multicentre randomised controlled trial encompassing 3,697 patients with hip replacement and 3,110 patients with knee replacement enrolled from 2019 to 2020 in 9 German hospitals. The analysis was conducted with a subset of 546 hip and 492 knee replacement cases with longitudinal cost data from 24 statutory health insurances. Patients were randomised 1:1 to a PROM-based remote monitoring and alert intervention or to a standard care group. All patients were assessed at 12-months post-surgery via digitally collected PROMs. Patients within the intervention group were additionally assessed at 1-, 3-, and 6-months post-surgery to be contacted in case of critical recovery paths. For the effect evaluation, a PROM-based composite measure (PRO-CM) was developed, combining changes across various PROMs in a single index ranging from 0 to 100. The PRO-CM included 6 PROMs focused on quality of life and various aspects of physical and mental health. The primary outcome was the incremental cost-effectiveness ratio (ICER). The intervention group showed incremental outcomes of 2.54 units PRO-CM (95% confidence interval (CI) [0.93, 4.14]; p = 0.002) for patients with hip and 0.87 (95% CI [-0.94, 2.67]; p = 0.347) for patients with knee replacement. Within the 12-months post-surgery period the intervention group had less costs of 376.43€ (95% CI [-639.74, -113.12]; p = 0.005) in patients with hip, and 375.50€ (95% CI [-767.40, 16.39]; p = 0.060) in patients with knee replacement, revealing a dominant ICER for both procedures. However, it remains unclear which step of the multistage intervention contributes most to the positive effect. The intervention significantly improved patient outcomes at lower costs in patients with hip replacements when compared with standard care. Further it showed a nonsignificant cost reduction in knee replacement patients. This reinforces the notion that PROMs can be utilised as a cost-effective instrument for remote monitoring in standard care settings. Registration: German Register for Clinical Studies (DRKS) under DRKS00019916.

Improving Medication Adherence in Geriatric T2DM Patients: A Factorial Randomized Controlled Trial

Abstract Background: The complexity of managing type 2 diabetes (T2D) in the elderly is compounded by the need to balance over-prescription, under-prescription, and appropriate prescription. Managing hyperglycemia and its complications, along with geriatric syndromes such as cognitive impairment and falls, often leads to use of an increased number of medications. Quality improvement measures, while aimed at better management, can inadvertently contribute to the burden of polypharmacy. Addressing medication non-adherence is crucial, as it is a significant contributor to poor clinical outcomes, increased hospitalizations, and healthcare costs. Objectives: This study thus aimed to evaluate the effectiveness of interventions to improve medication adherence among elderly patients with T2D. It assessed the impact of a medication adherence device, clinical pharmacological intervention, and their combination compared to standard of care (SOC) alone on adherence rates, adverse drug reactions (ADRs), and glycemic control. Materials and Methods: This pilot study was a factorial randomized controlled trial. A total of 120 elderly T2D patients with a medication adherence rate of less than 80% over the past year were randomized into four groups: (1) medication adherence device + SOC, (2) clinical pharmacological intervention + SOC, (3) combined intervention + SOC, and (4) SOC alone. The primary outcome was medication adherence, assessed through pill counting. ADRs were evaluated using the Naranjo ADR causality assessment scale, and glycemic control was monitored through HbA1c levels. Statistical analyses included chi-square tests and ANOVA, with significance set at P &lt; 0.05. Results: Interim analysis showed the highest adherence rate in the combined intervention group (82.1%), followed by the clinical pharmacological intervention + SOC group (75.3%), the medication adherence device + SOC group (73.1%), and the SOC alone group (70.0%). The combined intervention group also recorded the lowest ADR rate (6.6%). Regarding glycemic control, 81% of the combined intervention group achieved an HbA1c level of less than 7%, compared to 80% in the clinical pharmacological intervention + SOC group, 78% in the medication adherence device + SOC group, and 69% in the SOC alone group. Differences in glycemic control were not statistically significant (P = 0.950). Conclusions: The study indicates that combined interventions including medication adherence devices along with SOC significantly improve medication adherence and reduce ADRs in elderly T2D patients. Future research should focus on diverse populations and long-term sustainability of these interventions.

Randomized study of temporary diaphragm pacing for enhanced recovery after surgery in cardiac surgery patients at risk of prolonged mechanical ventilation

ObjectiveProlonged mechanical ventilation after cardiac surgery significantly increases morbidity and mortality. The aim of this study is to establish the role of diaphragmatic pacing to decrease mechanical ventilation burden in high-risk patients undergoing cardiac surgery. MethodsThis is a prospective, randomized trial of temporary diaphragmatic pacing electrode use in patients undergoing cardiac surgery (NCT04899856). Prognostic enrichment strategy was used to identify patients at higher risk of prolonged mechanical ventilation by having inclusion criteria of prior open cardiac surgery, left ventricular ejection fraction less than 30%, history of stroke, intra-aortic balloon pump, or history of chronic obstructive pulmonary disease. Two electrodes were placed in each hemidiaphragm intraoperatively. On arrival to the intensive care unit, patients were randomized to immediate diaphragmatic pacing or standard of care. ResultsForty patients received implants, with 19 in the treatment group and 21 in the standard of care group. Only 1 patient in the treatment group was on mechanical ventilation at 24 hours versus 4 patients in the standard of care group, resulting in a relative risk reduction of 71% being on mechanical ventilation at 24 hours postoperatively. Predictive enrichment strategy was used to identify patients most likely to respond to therapy of diaphragmatic pacing. In this analysis, median time on mechanical ventilation was 17.7 hours (interquartile range, 8.3-23.4) for the 15 patients in the standard of care group and 9.4 hours (interquartile range, 7.14-12.5) for the 13 patients in the treatment group, for an improvement of 8 hours with diaphragm pacing (P < .05). ConclusionsTemporary diaphragmatic pacing improved weaning from mechanical ventilation by 8 hours with a significant reduction of prolonged mechanical ventilation. Multicenter randomized trials confirming diaphragmatic pacing as an Enhanced Recovery After Surgery tool to decrease mechanical ventilation may reduce length of stay, postoperative infections, and additive costs.

Early integration of palliative care versus standard cardiac care for patients with heart failure (EPCHF): a multicentre, parallel, two-arm, open-label, randomised controlled trial

Heart failure is a substantial global health concern that severely affects patients' quality of life. We aimed to compare the effects of early integration of palliative care (EIPC) and standard cardiac care on health status and mood of patients with non-terminal heart failure. EPCHF was a multicentre, parallel, two-arm, open-label, randomised controlled trial carried out at University Hospital Bonn and University Hospital Düsseldorf in Germany. Eligible patients (aged 18years or older) had heart failure, with New York Heart Association class IIor more and NT-proBNP concentrations greater than or equal to 400pg/mL. Patients were randomly assigned (1:1) to receive EIPC with standard cardiac care or standard cardiac care alone. Randomisation was computer-generated with allocation concealment, variable block sizes, and stratification by investigational site. The primary endpoints were health status and mood, measured every 3months over 12months using the Functional Assessment of Chronic Illness Therapy-Palliative Care (FACIT-PAL) and the Kansas City Cardiomyopathy Questionnaire (KCCQ), analysed by intention to treat. This trial is registered with DRKS.de, DRKS00013922. Between May 21, 2019, and Nov 15, 2021, 843patients were assessed for eligibility, 205of whom were enrolled (100 assigned to EIPC and 105assigned to standard cardiac care). 143 (70%) patients were male and 62 (30%) were female. Over 12months, both groups significantly improved in FACIT-PAL and KCCQ Overall Summary Score(OSS) with no significant differences between the groups (FACIT-PAL adjusted mean difference 0·98points [95% CI -1·28to 3·23]; p=0·40; KCCQ-OSS adjusted mean difference -2·06points [-7·89to 3·78]; p=0·49). Nine (9%) patients in the EIPC group and seven (7%) patients in the standard cardiac care group died from any cause, with no significant differences in time to death between the two groups (hazard ratio [HR] 1·32 [95% CI 0·49 to 3·54]; p=0·58). 22 (22%) patients in the EIPC group and 21 (21%) patients in the standard cardiac care group were hospitalised at least once due to heart failure, with no significant differences in time to heart-failure-related hospitalisation between the two groups (HR 1·09 [0·61 to 1·98]; p=0·77). 70 (70%) patients in the EIPC group and 62 (59%) in the standard cardiac care group had any adverse events (p=0·10). In this open-label, randomised clinical trial, standard cardiac care, featuring guideline-directed optimisation of medical therapy and regular 3-monthly follow-ups was found to be as effective as when combined with EIPC in improving health status and mood in patients with non-terminal heart failure. Future clinical practices should consider EIPC based on individual patient needs. Federal Ministry of Education and Research.