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.

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.

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.

RATIONALE:

Family, and sometimes longstanding friends, have considerable influence over organ donation, through agreeing or disagreeing to the donation of a deceased individual's organs. To date, most research has been undertaken within opt-in systems.

OBJECTIVE:

This study advances on previous research by assessing next-of-kin approval under opt-out legislation. We tested whether next-of-kin approval varies when the deceased is a registered donor (opted-in), registered non-donor (opted-out) or has not registered a decision under an opt-out policy (deemed consent). We also tested if the deceased's wishes influenced next-of-kin approval through relatives anticipating regret for not donating and feelings of uncertainty. Finally, we assessed whether next-of-kin's own beliefs about organ donation influenced whether they followed the deceased's wishes.

METHODS:

Participants (N = 848) living in a country with opt-out legislation (Wales, UK) were asked to imagine a relative had died under an opt-out system and decided if their relatives' organs should be donated. Participants were randomly allocated to imagine the deceased had either (i) opted-in, (ii) opted-out or (iii) not registered a decision (deemed consent). The outcome variable was next-of-kin approval, with uncertainty and anticipated regret as potential mediators and next-of-kin's beliefs about organ donation as moderators.

RESULTS:

Next-of-kin approval was lower when the deceased had opted-out than under deemed consent. This was due to next-of-kin anticipating more regret for not donating under deemed consent than opt-out. Further analyses revealed the deceased's wishes influence next-of-kin approval, via anticipated regret, when next-of-kin did not hold negative beliefs about organ donation.

CONCLUSIONS:

The deceased's wishes were less likely to be followed when next-of-kin had negative beliefs towards donation. Developing large-scale campaigns to improve these beliefs in the general public should make people more likely to follow the deceased's wishes. As a result, these campaigns should improve the availability of donor organs.

BACKGROUND:

Therapies for refractory cytomegalovirus infections (with or without resistance [R/R]) in transplant recipients are limited by toxicities. Maribavir has multimodal anti-cytomegalovirus activity through the inhibition of UL97 protein kinase.

METHODS:

In this phase 3, open-label study, hematopoietic-cell and solid-organ transplant recipients with R/R cytomegalovirus were randomized 2:1 to maribavir 400 mg twice daily or investigator-assigned therapy (IAT; valganciclovir/ganciclovir, foscarnet, or cidofovir) for 8 weeks, with 12 weeks of follow-up. The primary endpoint was confirmed cytomegalovirus clearance at end of week 8. The key secondary endpoint was achievement of cytomegalovirus clearance and symptom control at end of week 8, maintained through week 16.

RESULTS:

352 patients were randomized (235 maribavir; 117 IAT). Significantly more patients in the maribavir versus IAT group achieved the primary endpoint (55.7% vs 23.9%; adjusted difference [95% confidence interval (CI)]: 32.8% [22.80-42.74]; P < .001) and key secondary endpoint (18.7% vs 10.3%; adjusted difference [95% CI]: 9.5% [2.02-16.88]; P = .01). Rates of treatment-emergent adverse events (TEAEs) were similar between groups (maribavir, 97.4%; IAT, 91.4%). Maribavir was associated with less acute kidney injury versus foscarnet (8.5% vs 21.3%) and neutropenia versus valganciclovir/ganciclovir (9.4% vs 33.9%). Fewer patients discontinued treatment due to TEAEs with maribavir (13.2%) than IAT (31.9%). One patient per group had fatal treatment-related TEAEs.

CONCLUSIONS:

Maribavir was superior to IAT for cytomegalovirus viremia clearance and viremia clearance plus symptom control maintained post-therapy in transplant recipients with R/R cytomegalovirus. Maribavir had fewer treatment discontinuations due to TEAEs than IAT. Clinical Trials Registration. NCT02931539 (SOLSTICE).

BACKGROUND:

Our objective was to determine if the addition of ultraviolet-C (UV-C) light to daily and discharge patient room cleaning reduces healthcare-associated infection rates of vancomycin-resistant enterococci (VRE) and Clostridioides difficile in immunocompromised adults.

METHODS:

We performed a cluster randomized crossover control trial in 4 cancer and 1 solid organ transplant in-patient units at the Johns Hopkins Hospital, Baltimore, Maryland. For study year 1, each unit was randomized to intervention of UV-C light plus standard environmental cleaning or control of standard environmental cleaning, followed by a 5-week washout period. In study year 2, units switched assignments. The outcomes were healthcare-associated rates of VRE or C. difficile. Statistical inference used a two-stage approach recommended for cluster-randomized trials with <15 clusters/arm.

RESULTS:

In total, 302 new VRE infections were observed during 45787 at risk patient-days. The incidence in control and intervention groups was 6.68 and 6.52 per 1000 patient-days respectively; the unadjusted incidence rate ratio (IRR) was 0.98 (95% confidence interval [CI], .78 - 1.22; P = .54). There were 84 new C. difficile infections observed during 26118 at risk patient-days. The incidence in control and intervention periods was 2.64 and 3.78 per 1000 patient-days respectively; the unadjusted IRR was 1.43 (95% CI, .93 - 2.21; P = .98).

CONCLUSIONS:

When used daily and at post discharge in addition to standard environmental cleaning, UV-C disinfection did not reduce VRE or C. difficile infection rates in cancer and solid organ transplant units.

OBJECTIVES:

Infection remains a major complication of organ transplantation. Paradoxically, epidemiological studies suggest better survival from serious infection. We analysed the relationship between organ transplantation and short -term mortality of patients with bloodstream infection.

METHODS:

Data on transplantation status was extracted from a large prospective, multi-centre clinical trial in bloodstream infection. Logistic regression for 28-day mortality was performed on the whole cohort and a propensity-matched cohort (3:1). Infective pathogen, focus of infection, and clinical variables were included in the model. Mediation analysis was performed on clinical variables to explore causation.

RESULTS:

4,178 participants were included in the full cohort, with 868 in the matched cohort, of which 217 received an organ transplant. Haematopoietic stem cell transplants (HSCT) were the most common transplant (n = 99), followed by kidney (n = 70). The most common pathogens were staphylococci and Enterobacterales. Transplantation status was associated with a reduced mortality in both the whole (Odds Ratio, OR 0.53; 95% CI 0.28, 0.77) and matched (OR 0.55, 95% CI 0.34, 0.90) cohort, while steroid use was robustly associated with increased mortality OR 4.4 (95% CI 3.12, 6.20) in the whole cohort and OR 5.24 (95% CI 2.79, 9.84) in the matched cohort. There was no interaction between steroid use and transplant status, so transplant patients on steroids generally had increased mortality relative to those without either.

CONCLUSIONS:

Organ transplantation is associated with a near halving of short term mortality in bloodstream infection, including a cohort matched for comorbidities, infective pathogen and focus. Steroid usage is associated with increased mortality regardless of transplant status. Understanding the mechanism and causation of this mortality benefit should be a focus of future research.

We assessed whether videos with medical footage of organ preservation and transplantation plus sad, unresolved, or uplifting stories differentially affect deceased organ donor registration among clients in Latinx-owned barbershops and beauty salons. In a 2 × 3 randomized controlled trial, participants (N = 1,696, mean age 33 years, 67% female) viewed one of six videos. The control portrayed a mother who received a kidney (uplifting), excluding medical footage. Experimental videos included medical footage and/or showed a mother waiting (unresolved) or sisters mourning their brother's death (sad). Regression models assessed relative impact of medical footage and storylines on: (1) registry enrollment, (2) donation willingness stage of change, and (3) emotions. Randomization yielded approximately equal groups relative to age, sex, education, religion, nativity, baseline organ donation willingness, beliefs, and emotions. Overall, 14.8% of participants registered. Neither medical footage, sad, nor unresolved stories differentially affected registration and changes in organ donation willingness. Sad and unresolved stories increased sadness and decreased positive affect by ~0.1 logits compared with the uplifting story. Educational videos about organ donation which excluded or included medical footage and varying emotional valence of stories induced emotions marginally but did not affect viewers' registration decisions differently. Heterogeneity of responses within video groups might explain the attenuated impact of including medical footage and varying emotional content. In future work, we will report qualitative reasons for participants' registration decisions by analyzing the free text responses from the randomized trial and data from semistructured interviews that were conducted with a subset of participants.