Transplant Evidence Alert

The Transplant Evidence Alert provides a monthly overview of the 10 most important new clinical trials in organ transplantation, selected and reviewed by the Peter Morris Centre for Evidence in Transplantation (Oxford University).

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November 2023

Heart
  • Rafique M
  • Solberg OG
  • Gullestad L
  • Bendz B
  • Murbræch K
  • et al.
BMJ Open Sport Exerc Med. 2023 Jul 9;9(3):e001331 doi: 10.1136/bmjsem-2022-001331.
CET Conclusion
Reviewer: Mr John Fallon, Centre for Evidence in Transplantation, Nuffield Department of Surgical Sciences University of Oxford
Conclusion: This was a sub-study within a multicentre randomised control trial (HITTS), with these participants from a single centre in Norway and in which the cardiac assessments were performed by blinded investigators. The HITTS trial found that HIT early after HTx resulted in an improved VO2peak compared with MICT, as a result they are investigating the hypothesis that alterations to cardiac physiology may have partially caused this improvement. They found that LV GLS and EDV had statistically significant improvements as did IMR, suggesting that HIT early after HTx improves the microcirculatory function. However, these changes did not have a significant correlation with VO2peak at 12 months which was the primary endpoint of the original trial, making it harder to hold these changes are in part responsible for improved VO2peak. The main HITTS trial has robust methodology, but this, by the nature of being a sub-study, has limitations. Given the sample size was powered for VO2peak in the main HITTS trial, the result being a small sample size for the single centre sub-study. Despite limitations they find beneficial adaptions in the cardiovascular system as a result of the HIT, which they evaluate in more in-depth assessment than done in the original trial giving a possible mechanistic background to explain some of the improvements seen in the HITTS trial.
Aims: They aim to assess if high-intensity interval training (HIT) results in structural and functional cardiac adaptation in de novo heart transplant recipients compared with standard care exercised-based rehabilitation.
Interventions: Participants received either 9 months of HIT (four 4 min intervals at 85-95% peak effort with 3 min recovery at 60-70%) or moderate-intensity continuous training (MICT) (25 min of continuous training at 60-80% peak effort) which is the standard care recommended by the European Society of Cardiology.
Participants: 81 adult de novo heart transplant (HTx) recipients
Outcomes: The primary outcomes were changes in left ventricular (LV) global longitudinal strain (GLS), and echo assessment of LV dimensions and end-diastolic volume (EDV). The secondary outcomes were the changes in index of microcirculatory resistance (IMR) and coronary flow reserve (CFR).
Follow Up: 12 months posttransplantation.
OBJECTIVES:

High-intensity interval training (HIT) improves peak oxygen consumption (VO2peak) in de novo heart transplant (HTx) recipients. It remains unclear whether this improvement early after HTx is solely dependent on peripheral adaptations, or due to a linked chain of central and peripheral adaptations. The objective of this study was to determine whether HIT results in structural and functional adaptations in the cardiovascular system.

METHODS:

Eighty-one de novo HTx recipients were randomly assigned to participate in either 9 months of supervised HIT or standard care exercise-based rehabilitation. Cardiac function was assessed by echocardiogram and the coronary microcirculation with the index of microcirculatory resistance (IMR) at baseline and 12 months after HTx.

RESULTS:

Cardiac function as assessed by global longitudinal strain was significantly better in the HIT group than in the standard care group (16.3±1.2% vs 15.6±2.2%, respectively, treatment effect = -1.1% (95% CI -2.0% to -0.2%), p=0.02), as was the end-diastolic volume (128.5±20.8 mL vs 123.4±15.5 mL, respectively, treatment effect=4.9 mL (95% CI 0.5 to 9.2 mL), p=0.03). There was a non-significant tendency for IMR to indicate improved microcirculatory function (13.8±8.0 vs 16.8±12.0, respectively, treatment effect = -4.3 (95% CI -9.1 to 0.6), p=0.08).

CONCLUSION:

When initiated early after HTx, HIT leads to both structural and functional cardiovascular adaptations.

TRIAL REGISTRATION NUMBER:

NCT01796379.

Kidney
  • Steenvoorden TS
  • van Duin RE
  • Rood JAJ
  • Peters-Sengers H
  • Nurmohamed AS
  • et al.
Br J Clin Pharmacol. 2023 Dec;89(12):3629-3636 doi: 10.1111/bcp.15871.
CET Conclusion
Reviewer: Mr John O'Callaghan, Centre for Evidence in Transplantation, Nuffield Department of Surgical Sciences University of Oxford
Conclusion: This is a small study, albeit randomised. Only 5 patients received the alkaline phosphatase treatment and 6 placebo. Given the prior successful use of alkaline phosphatase in cardiac surgery patients could it not have been used in a larger study here, and therefore have more potential to identify any beneficial impact? The study was also conducted only in live kidney transplantation and therefore the potential impact on any ischeamia-reperfusion injury was relatively minimal. Donation after cardiac death is where any potential benefit lies. As it stands, the study showed no real difference between placebo and alkaline phosphatase. The study drug was safely administered in this small group of recipients.
Aims: The aim of this study was to assess the feasibility and safety of alkaline phosphatase for treating ischaemia–reperfusion injury in living donor kidney transplantation.
Interventions: Participants were randomised to either the alkaline phosphatase (bRESCAP) group or the placebo group.
Participants: 11 living donor kiney transplant recipients.
Outcomes: The primary endpoint was 1-year graft function. The secondary endpoints included (serious) AEs (SAEs), and urine and serum biomarkers.
Follow Up: 1 year posttransplantation
AIMS:

Ischemia-reperfusion injury (IRI) during kidney transplant procedures is associated with adverse outcome. Alkaline phosphatase (AP) is an enzyme that has the potential to dampen IRI. Prior to this study, it had not been tested in the setting of kidney transplantation. This study aimed to evaluate the safety and feasibility of peri-procedural AP administration in living donor kidney transplantation.

METHODS:

In this double blind, randomized, placebo-controlled, single-center pilot study, all eligible recipients of living donor kidneys were asked to give informed consent. AP (bRESCAP) or a placebo was administered intravenously over 24 hours after the transplantation procedure. The primary outcome-graft function at 1 year-was represented by iohexol measured glomerular filtration rate (mGFR). Serum and urine biomarkers within seven days after surgery were used as surrogate markers of kidney function and injury.

RESULTS:

Eleven patients were enrolled of whom five were treated with bRESCAP and six with placebo. After 1 year, mGFR was not different between groups. No specific adverse events were observed in the bRESCAP group. Urine expression of injury biomarkers CCL14, NGAL and Cystatin C was lower in the bRESCAP group at day seven. This was statistically significant.

CONCLUSION:

This study illustrates that bRESCAP treatment is feasible in kidney transplantation, might have a dampening effect on IRI induced renal inflammation, and raises no safety concerns. Future research will evaluate the effects of bRESCAP treatment in donation after circulatory death kidney transplantation where IRI is more pronounced.

  • Mac Curtain BM
  • Qian W
  • Temperley HC
  • O'Mahony A
  • Ng ZQ
  • et al.
Hernia. 2023 Sep 15; doi: 10.1007/s10029-023-02879-9.
CET Conclusion
Reviewer: Mr Keno Mentor, Centre for Evidence in Transplantation, Nuffield Department of Surgical Sciences University of Oxford
Conclusion: This systematic review synthesised the available data reporting on the rate and associated risk factors of incisional hernia (IH) after renal transplantation. The authors report on pooled results which are broadly similar to that of other surgical groups, with obesity, smoking and immunosuppression reported as the main risk factors for the development of IH. There are a number of fundamental errors in the statistical analysis. For example, forest plots are used inappropriately to depict cross-sectional data, and the risk of bias tool was modified by the authors resulting in all included studies being rated as ‘good’ or ‘very good’.
Aims: This study aimed to summarise the current literature on rates, risk factors and outcomes of incisional hernias following renal transplantation.
Interventions: Electronic databases including PubMed, EMBASE and the Cochrane CENTRAL were searched. Studies were selected independently by two reviewers and data were extracted independently by three reviewers. Risk of bias was assessed using a modified Newcastle–Ottawa scale.
Participants: 20 studies were included in the review.
Outcomes: The primary outcome was rates of IH. Secondary outcomes included risk factors for IH, and management and outcomes of IH.
Follow Up: N/A
PURPOSE:

Incisional hernia (IH) post renal transplant (RT) is relatively uncommon and can be challenging to manage clinically due to the presence of the kidney graft and patient immunosuppression. This systematic review and meta-analysis synthesises the current literature in relation to IH rates, risk factors and outcomes post RT.

METHODS:

PubMed, EMBASE, and Cochrane Central Registry of Controlled Trials (CENTRAL) were searched up to July 2023. The most up to date Preferred Reporting Items for Systematic Reviews and Meta Analyses guidelines were followed. Pertinent clinical information was synthesised. A meta-analysis of the pooled proportions of IH rates, the rates of patients requiring surgical repair and the rates of recurrence post RT are reported.

RESULTS:

Twenty studies comprising 16,018 patients were included in this analysis. The pooled rate of IH occurrence post RT was 4% (CI 3-5%). The pooled rate of IH repair post RT was 61% (CI 14-100%). The pooled rate of IH recurrence after repair was 16% (CI 9-23%). Risk factors identified for IH development post RT are BMI, immunosuppression, age, smoking, incision type, reoperation, concurrent abdominal wall hernia, lymphocele formation and pulmonary disease.

CONCLUSIONS:

IH post RT is uncommon and the majority of IH post RT are repaired surgically on an elective basis.

  • van den Born JC
  • Meziyerh S
  • Vart P
  • Bakker SJL
  • Berger SP
  • et al.
CET Conclusion
Reviewer: Mr Simon Knight, Centre for Evidence in Transplantation, Nuffield Department of Surgical Sciences University of Oxford
Conclusion: This multicentre trial from the Netherlands randomised de novo renal transplant recipients to one of three immunosuppression strategies – standard care, early steroid withdrawal or tacrolimus minimisation at 6 months. The study was designed to demonstrate non-inferiority in renal function at 24 months, and met the primary endpoint, with no difference seen between the three groups. There was a higher incidence of acute rejection in the early steroid withdrawal group, but no increase in DSA formation. In general, study design is good although unblinded, with centralised randomisation and intent-to-treat analysis. Withdrawal rate was around 25% in each arm at 24 months. Inclusion criteria are fairly broad for an immunosuppression minimisation study, allowing recipients up to 80 years of age, PRA up to 75% and first or second transplants. One notable exclusion criteria was for type 1 diabetic recipients; the authors do not provide a rationale for this.
Aims: The aim of this trial was to compare standard immunosuppression with two immunosuppression minimisation strategies in de novo kidney transplant recipients.
Interventions: Participants were randomised to one of three groups: the early steroid withdrawal arm, the standard-dose tacrolimus arm, and the tacrolimus minimisation arm.
Participants: 295 de novo kidney transplant recipients.
Outcomes: The primary outcome was kidney function at 24 months posttransplantation. The secondary outcomes were patient survival, treated rejection, kidney failure, discontinuation of study medication for more than 6 weeks, and treatment failure.
Follow Up: 24 months
BACKGROUND:

Evidence on the optimal maintenance of immunosuppressive regimen in kidney transplantation recipients is limited.

METHODS:

The Amsterdam, LEiden, GROningen trial is a randomized, multicenter, investigator-driven, noninferiority, open-label trial in de novo kidney transplant recipients, in which 2 immunosuppression minimization strategies were compared with standard immunosuppression with basiliximab, corticosteroids, tacrolimus, and mycophenolic acid. In the minimization groups, either steroids were withdrawn from day 3, or tacrolimus exposure was reduced from 6 mo after transplantation. The primary endpoint was kidney transplant function at 24 mo.

RESULTS:

A total of 295 participants were included in the intention-to-treat analysis. Noninferiority was shown for the primary endpoint; estimated glomerular filtration rate at 24 mo was 45.3 mL/min/1.73 m2 in the early steroid withdrawal group, 49.0 mL/min/1.73 m2 in the standard immunosuppression group, and 44.7 mL/min/1.73 m2 in the tacrolimus minimization group. Participants in the early steroid withdrawal group were significantly more often treated for rejection (P = 0.04). However, in this group, the number of participants with diabetes mellitus during follow-up and total cholesterol at 24 mo were significantly lower.

CONCLUSIONS:

Tacrolimus minimization can be considered in kidney transplant recipients who do not have an increased immunological risk. Before withdrawing steroids the risk of rejection should be weighed against the potential metabolic advantages.

  • Quint EE
  • Haanstra AJ
  • van der Veen Y
  • Maring H
  • Berger SP
  • et al.
BMJ Open. 2023 Jul 27;13(7):e072805 doi: 10.1136/bmjopen-2023-072805.
CET Conclusion
Reviewer: Mr Keno Mentor, Centre for Evidence in Transplantation, Nuffield Department of Surgical Sciences University of Oxford
Conclusion: This study protocol outlines the rationale and methodology for a proposed randomised control trial which will assess the efficacy of a prehabilitation program applied to patients awaiting kidney transplantation. Patients will be randomised to either routine care or a 12-week home-based program compromised of physical, nutritional and psychosocial interventions. The primary outcome is a change of score on the Tilburg Frailty Indicator (TFI), a validated frailty assessment tool. Of note, all outcome measures are pre-operative only i.e. the post-operative and long-term outcomes related to graft and patient survival will not be assessed in this trial.
Aims: This protocol for a randomised controlled trial aims to evaluate the effectiveness of a prehabilitation programme among kidney transplant candidates.
Interventions: Participants will be randomised to either the prehabilitation group or the usual care group.
Participants: Adult kidney transplant candidates that are currently on the transplant waiting list or are waitlisted during the study period.
Outcomes: The primary outcome is change in frailty status. The secondary outcomes are changes in physical fitness, psychological well-being, nutritional status, quality of life and clinical outcomes.
Follow Up: 26 weeks post-randomisation.
INTRODUCTION:

Kidney transplant candidates (KTCs) need to be in optimal physical and psychological condition prior to surgery. However, KTCs often experience compromised functional capacity which can be characterised as frailty. Prehabilitation, the enhancement of a person's functional capacity, may be an effective intervention to improve the health status of KTCs. The PREhabilitation of CAndidates for REnal Transplantation (PreCareTx) study aims to examine the effectiveness of a multimodal prehabilitation programme on the health status of KTCs, and to explore the potential of implementation of prehabilitation in daily clinical practice.

METHODS AND ANALYSIS:

This study uses a single centre, effectiveness-implementation hybrid type I study design, comprised of a randomised controlled trial and a mixed-methods study. Adult patients who are currently on the transplant waiting list or are waitlisted during the study period, at a university medical centre in The Netherlands, will be randomly assigned to either prehabilitation (n=64) or care as usual (n=64) groups. The prehabilitation group will undergo a 12-week home-based, tailored prehabilitation programme consisting of physical and/or nutritional and/or psychosocial interventions depending on the participant's deficits. This programme will be followed by a 12-week maintenance programme in order to enhance the incorporation of the interventions into daily life. The primary endpoint of this study is a change in frailty status as a proxy for health status. Secondary endpoints include changes in physical fitness, nutritional status, psychological well-being, quality of life and clinical outcomes. Tertiary endpoints include the safety, feasibility and acceptability of the prehabilitation programme, and the barriers and facilitators for further implementation.

ETHICS AND DISSEMINATION:

Medical ethical approval was granted by the Medical Ethics Committee Groningen, Netherlands (M22.421). Written informed consent will be obtained from all participants. The results will be disseminated at international conferences and in peer-reviewed journals.

TRIAL REGISTRATION NUMBER:

ClinicalTrials.gov, NCT05489432.

  • Rheault MN
  • Amaral S
  • Bock M
  • Chambers ET
  • Chavers B
  • et al.
Front Nephrol. 2023 May 15;3:1181076 doi: 10.3389/fneph.2023.1181076.
CET Conclusion
Reviewer: Mr John Fallon, Centre for Evidence in Transplantation, Nuffield Department of Surgical Sciences University of Oxford
Conclusion: The investigators present their protocol for the first randomised multicentre trial of its kind, done so based on a lack of clarity from a meta-analysis of smaller retrospective studies on rituximab in FSGS recurrence. The methodology has some limitations, firstly it is not blinded, which given it is only a single dose of rituximab pre-transplant, blinding could have relatively easily been incorporated. The study has been powered based on paediatric FSGS recurrence rates which are slightly higher than that of the adult population, meaning there could be a degree of underpowering in the design. This may be compounded by their inclusion of minimal change disease which they have predicted to have the same recurrence rate of FSGS based on a single small retrospective cohort study. There is no genetic testing done in the adult population, which could introduce bias given genetic nephrotic syndromes are highly unlikely to recur. However, the randomisation is robust and done centrally, with the investigators confident that if recruitment target is reached the study will be a success.
Aims: The investigators aim to assess if rituximab primitively with plasmapheresis reduced recurrence of FSGS at 1 year compared to plasma pheresis alone.
Interventions: The interventional arm will receive plasmapheresis with rituximab and the control arm will receive plasma pheresis only.
Participants: 160 children or adults with biopsy proven FSGS or MCD receiving living or deceased donor kidney for their 1st, 2nd or 3rd transplant. Patients with monogenic FSGS or secondary cause of FSGS and those who received rituximab 1 year prior to transplant will be excluded.
Outcomes: The primary outcome is FSGS recurrence at 1 year. The secondary outcomes are: time to FSGS recurrence, graft survival, patient survival, graft function (eGFR), acute rejection and proportion with CD19+ <1% at 1 month, 6 months, and 12 months.
Follow Up: 12 months posttransplantation.
BACKGROUND:

Focal segmental glomerulosclerosis (FSGS) is a common cause of end-stage kidney disease requiring kidney transplantation and can recur in the allograft in 30-80% of recipients resulting in reduced graft survival. Plasmapheresis has shown efficacy in treating some cases of recurrent FSGS but isolated plasmapheresis has not demonstrated efficacy in preventing recurrent FSGS. Rituximab has had anecdotal success in preventing recurrence in a single center study but has not been studied in combination with plasmapheresis for preventing FSGS recurrence.

METHODS:

We are conducting a randomized, controlled, multicenter clinical trial of adult and pediatric kidney transplant recipients with primary FSGS to assess whether plasmapheresis in combination with rituximab prevents recurrent disease post-transplantation.

DISCUSSION:

Rituximab combined with plasmapheresis is a promising, novel therapy to prevent recurrent FSGS, a disease with limited therapeutic options and no consensus guidelines for prevention or treatment.

CLINICAL TRIAL REGISTRATION:

https://clinicaltrials.gov/ct2/show/NCT03763643, identifier NCT03763643.

Liver
  • Kovács E
  • Maimeri N
  • Orlando F
  • Morselli F
  • Pallanch O
  • et al.
Physiol Int. 2023 Aug 28;110(3):211-226 doi: 10.1556/2060.2023.00211.
CET Conclusion
Reviewer: Reshma Rana Magar, Centre for Evidence in Transplantation, Nuffield Department of Surgical Sciences University of Oxford
Conclusion: This systematic literature review aimed to provide an overview of all randomized controlled trials in which the intervention was observed to have a statistically significantly effect in reducing mortality in critically ill patients with acute liver failure (ALF) or cirrhosis. Four independent reviewers were involved in the selection of eligible studies and data extraction. Nine RCTs were included in the review. However, the methodological quality of the included studies was not assessed. The authors found that antibiotic therapy was effective in reducing mortality among cirrhotic patients requiring hospitalization or ICU treatment. Tacrolimus administration following liver transplantation, albumin, HVP exchange and N-acetylcysteine were also associated with mortality reduction in specific aspects of hepatic failure during hospitalization and ICU therapy. Additionally, a positive effect of terlipressin in cirrhotic patients with sepsis was also observed.
Aims: The aim of this study was to identify all randomised controlled trials that showed a statistically significant effect of an intervention in reducing mortality in patients with hepatic failure.
Interventions: A literature search was conducted in three databases including PubMed, Scopus and Embase. Study selection and data extraction were performed by two independent reviewers.
Participants: 9 studies were included in the review.
Outcomes: The main outcome of interest included statistically significant differences in mortality between the intervention and control groups.
Follow Up: N/A
BACKGROUND:

Acute and chronic hepatic failure can lead to increased mortality in critically ill and perioperative patients. Understanding the pathophysiological principles of these conditions in critically ill patients is of great importance to reduce mortality. The aim of our systematic literature review was to identify all randomized controlled trials on any intervention that had a statistically significant documented reduction in mortality in patients with hepatic failure.

METHODS:

We searched PubMed, Scopus and Embase databases for pertinent studies on January 1st 2021. The following studies were included: randomized controlled trials; studies investigating adult critically ill or perioperative patient populations with any form of hepatic failure; mortality as primary or secondary outcome; and statistically significant differences in mortality between the examined groups.

RESULTS:

We finally found nine trials in our systematic review on the effect of antibiotic administration and infectious diseases among patients with cirrhosis (three studies); immune modulation after liver transplantation (one study); administration of colloids in cirrhotic patients (one study); the effect of high-volume plasma exchange in acute liver failure (one study); administration of N-acetylcysteine in acute liver failure (one study); and treatment with terlipressin (two studies).

CONCLUSION:

In the present review we found only nine randomized studies with a documented survival benefit in patients with liver failure. Strategies that most improved mortality were associated with the outcome of sepsis and renal function.

  • Pedro RAM
  • Scharranch BC
  • Araújo LO
  • Brandão LS
  • Andrade LDC
  • et al.
Crit Care Sci. 2023 Mar 1;35(1):11-18 doi: 10.5935/2965-2774.20230336-en.
CET Conclusion
Reviewer: Mr John O'Callaghan, Centre for Evidence in Transplantation, Nuffield Department of Surgical Sciences University of Oxford
Conclusion: This is the protocol for a clinical trial in liver transplantation. The study intends to examine the impact of high versus low mean arterial pressure during liver transplantation and the impact of this on renal function. The “low” MAP group (control) represents MAP 65-75mmHg and the “high” MAP group target is 85-90mmHg. Renal dysfunction will be defined by KDIGO guideline of 1.5-fold increase from baseline. Randomisation will be online and within 2 hours of entering ICU after liver transplant. The group allocation cannot be blinded, understandably. The protocol details the generic and specific management of the intervention and control groups.
Aims: This protocol for a randomised controlled trial aims to investigate the effect of a higher mean arterial pressure on the incidence of renal dysfunction following liver transplantation.
Interventions: Participants will be randomly assigned to either the intevention arm with the highest mean arterial pressure (MAP) of 85 - 90mmHg or the control arm with the lowest MAP of 65 - 70mmHg, for a duration of 24 hours following admission to the intensive care unit (ICU) for liver transplantation.
Participants: Adult patients (>18 years) admitted to the ICU following liver transplantation.
Outcomes: The primary outcome is patient death within the first 7 days. The secondary outcomes include 28-day mortality, retransplantation, renal replacement therapy, surgical site infection, days alive and free of renal dysfunction, renal dysfunction, length of stay, length of hospital stay, days alive and hospitalization-free, liver graft dysfunction, liver graft dysfunction (primary nonfunction) and major adverse kidney events.
Follow Up: 28 days
OBJECTIVE:

To explain the rationale and protocol of the methods and analyses to be used in the LIVER-PAM randomized clinical trial, which seeks to understand whether a higher mean arterial pressure is capable of reducing the incidence of renal dysfunction postoperatively after liver transplantation.

METHODS:

LIVER-PAM is an open-label, randomized, controlled, singlecenter clinical trial. Patients randomized to the intervention group will have a mean arterial pressure of 85 - 90mmHg in the initial 24 hours of postoperative management, while patients in the control group will have a mean arterial pressure of 65 - 70mmHg in the same period. A sample of 174 patients will be required to demonstrate a 20% reduction in the absolute incidence of renal dysfunction, with a power of 80% and an alpha of 0.05.

CONCLUSION:

If a 20% reduction in the absolute incidence of renal dysfunction in the postoperative period of liver transplantation is achieved with higher target mean arterial pressure in the first 24 hours, this would represent an inexpensive and simple therapy for improving current outcomes in the management of liver transplant patients.ClinicalTrials.gov Registry: NCT05068713.

Various
  • Pekmezaris R
  • Cigaran E
  • Patel V
  • Clement D
  • Sardo Molmenti CL
  • et al.
World J Transplant. 2023 Jun 18;13(4):190-200 doi: 10.5500/wjt.v13.i4.190.
CET Conclusion
Reviewer: Mr Simon Knight, Centre for Evidence in Transplantation, Nuffield Department of Surgical Sciences University of Oxford
Conclusion: This randomised study from New York recruited adult Hispanic residents and delivered an online survey to elicit their knowledge and views on organ donation. Participants were randomised to watch an emotive video on deceased donation either before answering the survey, or after. The authors found that participants who watched the video before answering the survey showed more willingness to register as a donor (OR 2.05) and greater awareness as to how to sign up. The study is well designed and interesting, demonstrating how simple information provision may impact donation decisions in diverse populations. It is worth noting that the study did not measure actual registrations, just intent, and future studies should look at impact on actual registration rates as a closer proxy to real-world benefit.
Aims: The aim of this study was to evaluate whether an educational video was effective in improving organ donation intent among Hispanic New York residents.
Interventions: Participants were randomised to either view a short educational video on organ donation prior to the survey or to view the same video following the survey.
Participants: 365 Hispanic New York City (NYC) residents.
Outcomes: The main outcomes of interest were to assess the impact of the emotional video on willingness to donate, and to identify driving factors for organ donation.
Follow Up: N/A
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.