Clin Infect Dis. 2022 Sep 10;75(4):690-701 doi: 10.1093/cid/ciab988.
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Transplantation. 2022 Aug 1;106(8):1677-1689 doi: 10.1097/TP.0000000000004072.
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Ann Behav Med. 2019 May 3;53(6):592-595 doi: 10.1093/abm/kay060.
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Transpl Infect Dis. 2024 Apr;26(2):e14216 doi: 10.1111/tid.14216.
CET Conclusion
BACKGROUND:
Cytomegalovirus (CMV) infections among hematopoietic stem cell transplant (HSCT) and solid organ transplant (SOT) recipients impose a significant health care resource utilization (HCRU)-related economic burden. Maribavir (MBV), a novel anti-viral therapy (AVT), approved by the United States Food and Drug Administration for post-transplant CMV infections refractory (with/without resistance) to conventional AVTs has demonstrated lower hospital length of stay (LOS) versus investigator-assigned therapy (IAT; valgancilovir, ganciclovir, foscarnet, or cidofovir) in a phase 3 trial (SOLSTICE). This study estimated the HCRU costs of MBV versus IAT. METHODS:An economic model was developed to estimate HCRU costs for patients treated with MBV or IAT. Mean per-patient-per-year (PPPY) HCRU costs were calculated using (i) annualized mean hospital LOS in SOLSTICE, and (ii) CMV-related direct costs from published literature. Probabilistic sensitivity analysis with Monte-Carlo simulations assessed model robustness. RESULTS:Of 352 randomized patients receiving MBV (n = 235) or IAT (n = 117) for 8 weeks in SOLSTICE, 40% had HSCT and 60% had SOT. Mean overall PPPY HCRU costs of overall hospital-LOS were $67,205 (95% confidence interval [CI]: $33,767, $231,275) versus $145,501 (95% CI: $62,064, $589,505) for MBV and IAT groups, respectively. Mean PPPY ICU and non-ICU stay costs were: $32,231 (95% CI: $5,248, $184,524) versus $45,307 (95% CI: $3,957, $481,740) for MBV and IAT groups, and $82,237 (95% CI: $40,397, $156,945) MBV versus $228,329 (95% CI: $94,442, $517,476) for MBV and IAT groups, respectively. MBV demonstrated cost savings in over 99.99% of simulations. CONCLUSIONS:This analysis suggests that Mean PPPY HCRU costs were 29%-64% lower with MBV versus other-AVTs. |
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J Health Commun. 2024 Mar 3;29(3):200-210 doi: 10.1080/10810730.2024.2313988.
Concerns related to bodily integrity, medical mistrust, superstition, and disgust with respect to organ transplantation remain commonly cited barriers among African American, Caucasian, and Hispanic non-donors. The current study examined two narrative strategies for mitigating these barriers by eliciting feelings of happiness or sadness. African American, Caucasian, and Hispanic non-donors (N = 576) were randomly assigned to a radio ad that communicated either a recipient narrative or a waiting list narrative. As expected, the recipient narrative elicited greater feelings of happiness whereas the waiting list narrative aroused greater feelings of sadness. Moderated mediation analyses revealed models in which happiness, not sadness, was the mediator, such that the narrative frame was associated with ad persuasiveness. Additionally, only medical mistrust interacted with happiness to predict ad persuasiveness The results are discussed with an emphasis on message design strategies to employ among reluctant adult African American, Caucasian, and Hispanic potential donors. |
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Clin Infect Dis. 2024 Jan 25;78(1):48-56 doi: 10.1093/cid/ciad477.
CET Conclusion
BACKGROUND:
The immunogenicity of the standard influenza vaccine is reduced in solid-organ transplant (SOT) recipients, so new vaccination strategies are needed in this population. METHODS:Adult SOT recipients from 9 transplant clinics in Switzerland and Spain were enrolled if they were >3 months after transplantation. Patients were randomized (1:1:1) to a MF59-adjuvanted or a high-dose vaccine (intervention), or a standard vaccine (control), with stratification by organ and time from transplant. The primary outcome was vaccine response rate, defined as a ≥4-fold increase of hemagglutination-inhibition titers to at least 1 vaccine strain at 28 days postvaccination. Secondary outcomes included polymerase chain reaction-confirmed influenza and vaccine reactogenicity. RESULTS:A total of 619 patients were randomized, 616 received the assigned vaccines, and 598 had serum available for analysis of the primary endpoint (standard, n = 198; MF59-adjuvanted, n = 205; high-dose, n = 195 patients). Vaccine response rates were 42% (84/198) in the standard vaccine group, 60% (122/205) in the MF59-adjuvanted vaccine group, and 66% (129/195) in the high-dose vaccine group (difference in intervention vaccines vs standard vaccine, 0.20; 97.5% confidence interval [CI], .12-1); P < .001; difference in high-dose vs standard vaccine, 0.24 [95% CI, .16-1]; P < .001; difference in MF59-adjuvanted vs standard vaccine, 0.17 [97.5% CI, .08-1]; P < .001). Influenza occurred in 6% of the standard, 5% in the MF59-adjuvanted, and 7% in the high-dose vaccine groups. Vaccine-related adverse events occurred more frequently in the intervention vaccine groups, but most of the events were mild. CONCLUSIONS:In SOT recipients, use of an MF59-adjuvanted or a high-dose influenza vaccine was safe and resulted in a higher vaccine response rate. CLINICAL TRIALS REGISTRATION:Clinicaltrials.gov NCT03699839. |
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JAMA Netw Open. 2023 Dec 1;6(12):e2346901 doi: 10.1001/jamanetworkopen.2023.46901.
CET Conclusion
IMPORTANCE:
The effectiveness of goal-directed care to reduce loss of brain-dead potential donors to cardiac arrest is unclear. OBJECTIVE:To evaluate the effectiveness of an evidence-based, goal-directed checklist in the clinical management of brain-dead potential donors in the intensive care unit (ICU). DESIGN, SETTING, AND PARTICIPANTS:The Donation Network to Optimize Organ Recovery Study (DONORS) was an open-label, parallel-group cluster randomized clinical trial in Brazil. Enrollment and follow-up were conducted from June 20, 2017, to November 30, 2019. Hospital ICUs that reported 10 or more brain deaths in the previous 2 years were included. Consecutive brain-dead potential donors in the ICU aged 14 to 90 years with a condition consistent with brain death after the first clinical examination were enrolled. Participants were randomized to either the intervention group or the control group. The intention-to-treat data analysis was conducted from June 15 to August 30, 2020. INTERVENTIONS:Hospital staff in the intervention group were instructed to administer to brain-dead potential donors in the intervention group an evidence-based checklist with 13 clinical goals and 14 corresponding actions to guide care, every 6 hours, from study enrollment to organ retrieval. The control group provided or received usual care. MAIN OUTCOMES AND MEASURES:The primary outcome was loss of brain-dead potential donors to cardiac arrest at the individual level. A prespecified sensitivity analysis assessed the effect of adherence to the checklist in the intervention group. RESULTS:Among the 1771 brain-dead potential donors screened in 63 hospitals, 1535 were included. These patients included 673 males (59.2%) and had a median (IQR) age of 51 (36.3-62.0) years. The main cause of brain injury was stroke (877 [57.1%]), followed by trauma (485 [31.6%]). Of the 63 hospitals, 31 (49.2%) were assigned to the intervention group (743 [48.4%] brain-dead potential donors) and 32 (50.8%) to the control group (792 [51.6%] brain-dead potential donors). Seventy potential donors (9.4%) at intervention hospitals and 117 (14.8%) at control hospitals met the primary outcome (risk ratio [RR], 0.70; 95% CI, 0.46-1.08; P = .11). The primary outcome rate was lower in those with adherence higher than 79.0% than in the control group (5.3% vs 14.8%; RR, 0.41; 95% CI, 0.22-0.78; P = .006). CONCLUSIONS AND RELEVANCE:This cluster randomized clinical trial was inconclusive in determining whether the overall use of an evidence-based, goal-directed checklist reduced brain-dead potential donor loss to cardiac arrest. The findings suggest that use of such a checklist has limited effectiveness without adherence to the actions recommended in this checklist. TRIAL REGISTRATION:ClinicalTrials.gov Identifier: NCT03179020. |
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Am J Transplant. 2023 Dec;23(12):1939-1948 doi: 10.1016/j.ajt.2023.08.004.
CET Conclusion
An ambulatory medication safety dashboard was developed to identify missing labs, concerning labs, drug interactions, nonadherence, and transitions in care. This system was tested in a 2-year, prospective, cluster-randomized, controlled multicenter study. Pharmacists at 5 intervention sites used the dashboard to address medication safety issues, compared with usual care provided at 5 control sites. A total of 2196 transplant events were included (1300 intervention vs 896 control). During the 2-year study, the intervention arm had a 11.3% (95% confidence interval, 7.1%-15.5%) absolute risk reduction of having ≥1 emergency department (ED) visit (44.2% vs 55.5%, respectively; P < .001, respectively) and a 12.3% (95% confidence interval, 8.2%-16.4%) absolute risk reduction of having ≥1 hospitalization (30.1% vs 42.4%, respectively; P < .001). In those with ≥1 event, the median ED visit rate (2 [interquartile range (IQR) 1, 5] vs 2 [IQR 1, 4]; P = .510) and hospitalization rate (2 [IQR 1, 3] vs 2 [IQR 1, 3]; P = .380) were similar. Treatment effect varied by comorbidity burden, previous ED visits or hospitalizations, and heart or lung recipients. A bioinformatics dashboard-enabled, pharmacist-led intervention reduced the risk of having at least one ED visit or hospitalization, predominantly demonstrated in lower risk patients. |
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Liver Transpl. 2023 Nov 9; doi: 10.1097/LVT.0000000000000298.
CET Conclusion
Brain death triggers an inflammatory cascade that damages organs before procurement, adversely affecting the quality of grafts. This randomized clinical trial aimed to compare the efficacy of liraglutide compared to placebo in attenuating brain death-induced inflammation, endoplasmic reticulum stress, and oxidative stress. We conducted a double-blinded, placebo-controlled, randomized clinical trial with brain-dead donors. Fifty brain-dead donors were randomized to receive subcutaneous liraglutide or placebo. The primary outcome was the reduction in IL-6 plasma levels. Secondary outcomes were changes in other plasma pro-inflammatory (IL-1β, interferon-γ, TNF) and anti-inflammatory cytokines (IL-10), expression of antiapoptotic ( BCL2 ), endoplasmic reticulum stress markers ( DDIT3/CHOP , HSPA5/BIP ), and antioxidant ( superoxide dismutase 2 , uncoupling protein 2 ) genes, and expression TNF, DDIT3, and superoxide dismutase 2 proteins in liver biopsies. The liraglutide group showed lower cytokine levels compared to the placebo group during follow-up: Δ IL-6 (-28 [-182, 135] vs. 32 [-10.6, 70.7] pg/mL; p = 0.041) and Δ IL-10 (-0.01 [-2.2, 1.5] vs. 1.9 [-0.2, 6.1] pg/mL; p = 0.042), respectively. The administration of liraglutide did not significantly alter the expression of inflammatory, antiapoptotic, endoplasmic reticulum stress, or antioxidant genes in the liver tissue. Similar to gene expression, expressions of proteins in the liver were not affected by the administration of liraglutide. Treatment with liraglutide did not increase the organ recovery rate [OR = 1.2 (95% CI: 0.2-8.6), p = 0.82]. Liraglutide administration reduced IL-6 and prevented the increase of IL-10 plasma levels in brain-dead donors without affecting the expression of genes and proteins related to inflammation, apoptosis, endoplasmic reticulum stress, or oxidative stress. |
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Health Commun. 2023 Jul 23;1-13 doi: 10.1080/10410236.2023.2232607.
The organ shortage continues to present problems around the world including the United States. In response, some countries have switched from an opt-in organ donor registry to an opt-out registry. The United States currently utilizes an opt-in registry where an individual is not considered an organ donor until they register their intentions. In the current study, U.S. adults were randomly assigned to a 2 (message valence: promotional, refutational) x 2 (autonomy restoration postscript: present, not present) x 2 (social proof: high likes, low likes) posttest only control group design evaluating social media message regarding an opt-out organ donor registry for implementation in the U.S. Results revealed an interaction between message valence and autonomy on freedom threat perceptions toward the message. Consistent with psychological reactance theory, freedom threat perceptions were positively associated with reactance, which in turn was positively associated with an intention to sign a petition and call a representative to voice disapproval of the opt-out organ donor registry. The discussion is focused on pragmatic recommendations for organ donor practitioners and advocates as well as the theoretical contributions to reactance theory. |
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World J Transplant. 2023 Jun 18;13(4):190-200 doi: 10.5500/wjt.v13.i4.190.
CET Conclusion
BACKGROUND:
The Hispanic community has a high demand for organ donation but a shortage of donors. Studies investigating factors that could promote or hinder organ donation have examined emotional video interventions. Factors acting as barriers to organ donation registration have been classified as: (1) Bodily integrity; (2) medical mistrust; (3) "ick"-feelings of disgust towards organ donation; and (4) "jinx"-fear that registration may result in one dying due to premeditated plans. We predict that by providing necessary information and education about the donation process via a short video, individuals will be more willing to register as organ donors. AIM:To determine perceptions and attitudes regarding barriers and facilitators to organ donation intention among Hispanic residents in the New York metro politan area. METHODS:This study was approved by the Institutional Review Board at Northwell Health. The approval reference number is No. 19-0009 (as presented in Supplementary material). Eligible participants included Hispanic New York City (NYC) residents, 18 years of age and above, who were recruited voluntarily through Cloud Research and participated in a larger randomized survey study of NYC residents. The survey an 85-item Redcap survey measured participant demographics, attitudes, and knowledge of organ donation as well as the intention to register as an organ donor. Attention checks were implemented throughout the survey, and responses were excluded for those who did fail. Participants were randomly assigned two-between subject conditions: To view a short video on organ donation and then proceed to complete the survey (i.e., video first) and view the same video at the end of the survey (video last). No intra-group activities were conducted. This study utilized an evidenced-based emotive educational intervention (video) which was previously utilized and was shown to increase organ donation registration rates at the Ohio Department of Motor Vehicles. Results were analyzed using Jamovi statistical software. Three hundred sixty-five Hispanic individuals were included in the analysis. Once consent was obtained and participants entered the survey (the survey sample is presented in Supplementary material), participants were asked to report on demographic variables and their general impression of organ donation after death. The video depicted stories regarding organ donation after death from various viewpoints, including from the loved ones of a deceased person who died waiting for a transplant; from the loved ones of a deceased person whose organs were donated upon death; and, from those who were currently waiting for a transplant. RESULTS:Using a binomial logistic regression, the analysis provides information about the relationship between the effects of an emotive video and the intention to donate among Hispanic participants who were not already registered as donors. The willingness to go back and register was found to be significantly more probable for those who watched the emotive video before being asked about their organ donation opinions (odds ratio: 2.05, 95% confidence interval: 1.06-3.97). Motivations for participation in organ donation were also captured with many stating the importance of messages coming from "people like me" and a message that highlights "the welfare of those in need". Overall, the findings suggest that using an emotive video that addresses organ donation barriers to prompt organ donation intentions can be effective among the Hispanic populous. Future studies should explore using targeted messaging that resonates with specific cultural groups, highlighting the welfare of others. CONCLUSION:This study suggests that an emotive educational intervention is likely to be effective in improving organ donation registration intent among the Hispanic population residing in NYC. |
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Prog Transplant. 2023 Jun;33(2):121-129 doi: 10.1177/15269248231164177.
INTRODUCTION:
Medication errors, adverse events, and nonadherence in organ transplant recipients are common and can lead to suboptimal outcomes. A medication safety dashboard was developed to identify issues in medication therapy. RESEARCH QUESTIONS:Can a multicenter bioinformatics dashboard accurately identify clinically relevant medication safety issues in US military Veteran transplant recipients? DESIGN:The dashboard was tested through a 24-month, prospective, cluster-randomized controlled multicenter study. Pharmacists used the dashboard to identify and address potential medication safety issues, which was compared with usual care. RESULTS:Across the 10 sites (5 control sites and 5 intervention sites), 2012 patients were enrolled (1197 intervention vs 831 control). The mean age was 65 (10) years, 95% male, and 27% Black. The dashboard produced 18 132 alerts at a rate of 0.61(0.32) alerts per patient-month, ranging from 0.44 to 0.72 across the 5 intervention sites. Lab-based issues were most common (83.4%), followed by nonadherence (9.4%) and transitions in care (6.4%); 56% of alerts were addressed, taking an average of 43 (29) days. Common responses to alerts included those already resolved by another provider (N = 4431, 44%), the alert not clinically relevant (N = 3131, 31%), scheduling of follow-up labs (N = 591, 6%), and providing medication reconciliation/education (N = 99, 1%). Inaccurate flags significantly decreased over the study by a mean of -0.6% per month (95% CI -0.1 to -1.0; P = .0265), starting at 13.4% and ending at 2.6%. CONCLUSION:This multicenter cluster-randomized controlled trial demonstrated that a medication safety dashboard was feasibly deployable across the VA healthcare system, creating valid alerts. |
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Nurse Educ Pract. 2023 Mar;68:103596 doi: 10.1016/j.nepr.2023.103596.
AIM:
To develop and evaluate an educational programme aimed at undergraduate training to increase and improve knowledge, attitudes and behaviour towards the organ and tissue donation and transplants (OTDT). BACKGROUND:The request for OTDT falls on the health personnel and the reduction of family refusals depends on their attitude and competence, which is vital to increase OTDT. The evidence highlights the efficacy of starting training at early stages and the implementation of educational programmes in universities is recommended to reduce family refusals. DESIGN:A randomised controlled trial. METHODS:A randomised controlled trial with an experimental group (EG) -theory class and round table- and a control group (CG) -theory class- that transitions to a delayed experimental group. A sample of 73 students was distributed in parallel randomised groups. RESULTS:The groups increased their knowledge and improved their attitude, significantly changing their behaviour in the follow-up. These changes in the experimental groups were more significant than in CG in perceived quality of information (z = -4.948; p = <0.001), level of knowledge (EG1 and CG z = -2.245; p = 0.025) (EG2 and CG z = -2.215; p = 0.027), attitude (EG1 and CG z = -2.687; p = 0.007) (EG2 and CG z = -2.198; p = 0.028) and behaviour (EG1 and CG t = 2.054; p = 0.044) (EG2 and CG z = -2.797; p = 0.005). CONCLUSIONS:The education programme has proven effective, promoting knowledge, change and entrenchment of attitudes, facilitating conversations with families, enabling willingness to donate and increasing potential donors. |