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  • Mombelli M
  • Neofytos D
  • Huynh-Do U
  • Sánchez-Céspedes J
  • Stampf S
  • et al.
Clin Infect Dis. 2024 Jan 25;78(1):48-56 doi: 10.1093/cid/ciad477.
CET Conclusion
Reviewer: Mr John Fallon, Centre for Evidence in Transplantation, Nuffield Department of Surgical Sciences University of Oxford
Conclusion: This large multi-centre double-blinded randomised trial demonstrated a higher vaccine response using MF59-adjuvanated and high-dose influenza vaccines compared with standard vaccine, but this did not lead to improved clinical outcomes, with no difference in the incidence of influenza. Overall, the trial is robustly designed with clear outcome measures, though choosing the main clinically relevant outcome, clinical efficacy, as a secondary measure due the samples size this would require. The vaccine response in standard vaccine was 42%, 60% in MF-59-adjuvanted and 66% in the high dose group, while these differences are significant, if it does not translate to clinical outcome it is more difficult to make a case for their use given the increased cost and potential side effect burden. Adverse events occurred in 84% and 86% in the MF59-adjuvanted and high dose cohorts and only 59% for the standard vaccine, but all were mild side effects, such as: pain, redness, swelling, arthralgia, fatigue, and headache. De novo anti-HLA antibodies and biopsy-proven acute rejection was rare across all groups. Despite the vaccine response rate differences, when scrutinising seroprotection by strains within the trivalent vaccine (H1N1, H3N2 & B), one can see the potential cause for the lack of clinical efficacy. Across all three groups baseline protection is around 60% for H1N1 and around 30% for the other strains, likely due to the large number of participants (83%) who have previously received an influenza vaccine, and given the majority of participants are primary recipients, they are likely to have been immunocompetent at the time of the previous vaccine. They have demonstrated MF59-adjuvanted and high-dose vaccines to be safe in the solid organ transplant population, and given pervious evidence of clinical benefit in high risk populations such as the elderly, these vaccine could provide clinical benefit in transplant populations, but definitive evidence to alter practice is not provided here.
Aims: They aimed to evaluate whether MF59-adjuvanated or high-dose influenza vaccines elicited better immunogenicity, were safe had better clinical efficacy compared to standard vaccine.
Interventions: Intervention vaccines were MF59-adjuvanated and high-dose influenza vaccine versus control, standard influenze vaccine.
Participants: 598 adults who received a solid organ transplant >3 months prior to enrolment.
Outcomes: The primary outcome was antibody response rate at day 2 post-vaccine. The secondary clinical outcomes were influenza confirmed on PCR and vaccine reactogenicity. The secondary immunogenicity outcomes were: geometric mean titres of haemagglutination inhibition, seroproctection rates, seroconversion rates, seroconversion factors for each strain.
Follow Up: 180 days
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.

  • Westphal GA
  • Robinson CC
  • Giordani NE
  • Teixeira C
  • Rohden AI
  • et al.
JAMA Netw Open. 2023 Dec 1;6(12):e2346901 doi: 10.1001/jamanetworkopen.2023.46901.
CET Conclusion
Reviewer: Mr Keno Mentor, Centre for Evidence in Transplantation, Nuffield Department of Surgical Sciences University of Oxford
Conclusion: Potential brain-dead organ donors are frequently lost to cardiac arrest prior to organ retrieval. This unblinded randomised trial investigated the efficacy of employing an ICU-based checklist to optimise donor physiology to reduce the rate of donor loss. The checklist included various aspects of critical care management and was randomised to 743 patients (vs. 792 controls). Although there was a numerical improvement in the intervention group, there was no significant difference in rate of donor loss between the two groups. There are several important confounders that are not controlled for in this trial, but the most important limitation is due to the lack of blinding. ICU units in the control arm could have improved their practice in response to being included in such a trial, negating any potential effect due to the intervention.
Aims: This study aimed to investigate the whether an evidence-based, goal-directed checklist was effective in delaying cardiac arrest in brain-dead potential donors in the intensive care unit (ICU).
Interventions: At cluster level, eligible hospitals were randomised to provide either checklist guidance or usual care. At individual level, potential organ donors were randomised to receive either checklist guidance or usual care.
Participants: At cluster level, hospitals with a mean number of ≥ 10 brain-dead potential donors annually over the previous 2 years were eligible. At individual level, brain dead organ donors in the ICU (aged 14 to 90 years) were enrolled.
Outcomes: The primary endpoint was the loss of brain-dead potential donors to cardiac arrest. The secondary endpoints included the conversion of brain-dead potential donors to actual organ donors and the number of solid organs recovered per actual organ donor.
Follow Up: 14 days or until transfer from the ICU to the operating room
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.

  • Taber DJ
  • Ward RC
  • Buchanan CH
  • Axon RN
  • Milfred-LaForest S
  • et al.
Am J Transplant. 2023 Dec;23(12):1939-1948 doi: 10.1016/j.ajt.2023.08.004.
CET Conclusion
Reviewer: Mr Simon Knight, Centre for Evidence in Transplantation, Nuffield Department of Surgical Sciences University of Oxford
Conclusion: This interesting study from the US randomised 10 VA transplant centres, at a centre level, to use of a computerised alert dashboard designed to identify recipients at risk of non-adherence, drug interactions and abnormal/missing lab values. The authors found that use of the dashboard significantly reduced the incidence of hospital admissions (by 12.3%) and emergency department visits (by 11.3%), although the incidence of registry-reported acute rejection episodes was increased. There are potential issues with cluster randomisation in this type of study. When the number of centres is small, cluster randomisation can lead to imbalances in the groups in terms of baseline demographics and standard care levels. There is some evidence of this – ED visits and hospitalisations differed significantly in the year preceding the study between the control and intervention groups, and there are demographic and transplant mix differences as well. All of these may affect the risk of the outcomes. It is likely that the intervention was not used optimally by the participating pharmacists, with delays in responding to alerts and a lack of response to many. The key to successful implementation is therefore likely to be in optimising the workflow to ensure that alerts are acted upon in a timely fashion to achieve maximum benefit.
Aims: This study aimed to report the outcomes of the cluster-randomised ISTEP trial, which aimed to examine the effectiveness of a bioinformatics-driven dashboard to guide pharmacist-led medication therapy management intervention in solid organ transplant recipients.
Interventions: Participants were randomised to either standard care combined with the pharmacist-led, bioinformatics dashboard intervention or standard care alone.
Participants: 1982 veterans receiving 2196 transplants.
Outcomes: The primary endpoints were the overall rate of veterans affairs (VA) emergency department (ED) visits and VA hospitalisations. Secondary endpoints included patient survival, graft survival and acute rejection episodes.
Follow Up: 24 months

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.

  • Custódio G
  • Massutti AM
  • da Igreja MR
  • Lemos NE
  • Crispim D
  • et al.
Liver Transpl. 2023 Nov 9; doi: 10.1097/LVT.0000000000000298.
CET Conclusion
Reviewer: Mr John Fallon, Centre for Evidence in Transplantation, Nuffield Department of Surgical Sciences University of Oxford
Conclusion: This modest sized double-blinded, placebo-controlled RCT was robustly designed, with sound methodology, and demonstrated liraglutide treatment to the donor reduced circulating IL-6 and prevented increase in IL-10. While IL-6 is a pro-inflammatory cytokine which induces the expression of various transcription factors related to inflammation, in this study its reduction in the donor did not translate into any altered gene expression within the liver tissue. They also found no significant differences in their other inflammatory cytokines. In terms of correlation with outcome, the study was severely limited by the number transplanted in their own centre, resulting in a small cohort of recipients they were able to follow-up, they do not specifically report the rates of EAD, however on looking at the results, by Olthoff criteria the rates of EAD, were low and comparable. While the trial is not groundbreaking it is mechanistically interesting with the effects of the GLP-1 agonist measurable within the donors. It is also ethically interesting considering little research is done in donors currently, which could be a valuable window of opportunity to deliver therapies to improve organ outcomes.
Aims: To assess if delivery of liraglutide to brainstem death donors reduced donor inflammation prior to organ donations with correlation to liver transplant outcomes.
Interventions: The intervention group donors received 3mg of liraglutide subcutaneously (0.5mL) at the point of randomisation and then every 6 hours until donation. The placebo group received 0.5mL of normal saline.
Participants: 50 adult DBD donors, of which 12 livers went on to be transplanted in the study centre.
Outcomes: The primary outcome measure was IL-6 levels in the donor prior to first dose and immediately prior to retrieval. The secondary outcomes were donor plasma levels of IL-1β, IL-10, IFN-γ, TNF and BCL-2. Assessment of liver tissue for inflammation related gene expression and immunohistochemistry. The exploratory outcomes were the utilisation rate of the livers and early allograft dysfunction in the livers transplanted in the study centre.
Follow Up: The organ donation period

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.

  • Karar H
  • Shafiekhani M
  • Mahmoudi MM
  • Azadeh N
  • Shamsaeefar A
  • et al.
BMC Res Notes. 2023 Oct 26;16(1):295 doi: 10.1186/s13104-023-06568-9.
CET Conclusion
Reviewer: Mr Keno Mentor, Centre for Evidence in Transplantation, Nuffield Department of Surgical Sciences University of Oxford
Conclusion: This non-blinded randomised study compared two techniques for arterial anastomosis of the pancreas graft in simultaneous pancreas/kidney (SPK) transplant. The standard technique involves using a ‘y-graft’ derived from the bifurcation of the common iliac into the internal and external iliac arteries, while the modified technique tested in this study uses this standard technique with the addition of an extension graft derived from donor carotid artery. 30 patients were randomised equally between the two groups with no significant differences found in the primary outcomes of post-operative thrombosis, pancreatitis and surgical site infection. Small patient numbers and a lack of analysis of important donor and graft confounding factors (e.g. donor age, cold ischaemic time, etc) mean these findings cannot be generalised.
Aims: The aim of this study was to examine whether a novel technique for arterial reconstruction improves post-surgical outcomes in SPK transplant receipts.
Interventions: Participants were randomised to receive either the the Y-graft technique or the Y-graft and extension technique.
Participants: 30 simultaneous pancreas-kidney transplant recipeints.
Outcomes: The main clinical outcomes of this study were incidence of the post-surgical complications (pancreatitis, vascular events, fistula formation, and rejection).
Follow Up: 3 months following transplantation
INTRODUCTION:

Simultaneous pancreas kidney (SPK) transplantation is an invaluable procedure to enhance the quality of life of insulin-dependent patients with advanced renal disease. The creation of vascular anastomoses of the donor's pancreas vessels to the recipient's, is of utmost importance to predict the graft outcome and surgical complications. In the study we introduce a novel technique for arterial reconstruction during SPK transplantation.

METHODS:

Conventionally, during the SPK transplantation, a so-called Y-graft is anastomosed between donor's superior mesenteric and splenic artery to the recipient's right iliac artery. In the study we adopted a new technique by preparing an extra extension using the donor's carotid artery, to be anastomosed to the Y-graft and the iliac artery. In this non-blinded randomized clinical trial we compared the surgical complications and early outcomes between the 2 groups of patients with the traditional and new arterial reconstruction techniques during 3 months after transplantation.

RESULTS:

Thirty adult patients were included in the study. The incidence of pancreatitis, vascular thrombosis and surgical site infection was lower in the new Y-graft and extension technique, which was not statistically significant. However, the calculated Cohen's d index showed the medium effect of new Y-graft and extension technique on complication after SPK transplantations.

CONCLUSION:

The post-operative complications tend to be lower in the novel arterial reconstruction technique, however a study on a larger patient group is encouraged to confirm our primary results.

TRIAL REGISTRATION:

The study was registered at the Iranian Registry of Clinical Trials on 12/05/2022; IRCT 20210625051701N2; ( http://www.irct.ir/ ).

  • 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.

  • Zhang W
  • Feng X
  • Deng X
  • Jin M
  • Li J
  • et al.
Gland Surg. 2023 May 30;12(5):619-627 doi: 10.21037/gs-23-116.
CET Conclusion
Reviewer: Mr John O'Callaghan, Centre for Evidence in Transplantation, Nuffield Department of Surgical Sciences University of Oxford
Conclusion: This paper reports on a relatively large randomised controlled trial in kidney-pancreas transplantation. The key criticism of this paper is a lack of detail about what the control level of care was. The nurse-led MDT that was introduced is described in detail as a well-organised, responsive and well staffed system. It is not clear if this was compared to a control system of care that was completely unstructured and therefore unsurprising that there was a difference in patient outcomes. It is not clear if only a nurse-led MDT is required, or if the same result would have been seen with the introduction of such a well-structured scheme with a different lead clinician. The study included 218 patients and the intervention group had a significantly shorter length of stay, higher patient satisfaction, lower readmission rate, and pulmonary infection. The method of randomisation is not described and the study was only blinded for data analysis. The study was powered to detect a reduction in gastrointestinal (GI) bleeding, which seems like a very unusual primary outcome for such a study.
Aims: The aim of this study was to investigate the application of a transplant nurse-led multidisciplinary team (MDT) in the perioperative care of simultaneous pancreas and kidney transplantation (SPKT) patients.
Interventions: Participants were randomised to receive either the nurse-led MDT intervention group or the conventional care group.
Participants: 218 SPKT recipients.
Outcomes: The main outcomes of interest were incidence of postoperative complications, hospital stay, readmission rate, total cost of hospitalization and quality of postoperative nursing.
Follow Up: N/A
BACKGROUND:

Simultaneous pancreas and kidney transplantation (SPKT) is an effective treatment option for individuals who suffer from both diabetes mellitus and renal failure. However, experiments exploring nurse-led multidisciplinary team management during the perioperative management of patients undergoing SPKT are currently limited. This study aims to explore the clinical performance of a transplant nurse-led multidisciplinary team (MDT) in the perioperative management of SPKT patients.

METHODS:

A total of 218 patients who underwent SPKT were randomly assigned to either a control group (n=116) receiving conventional care or an intervention group (n=102) managed through a transplant nurse-led MDT approach. The incidence of postoperative complications, hospital stay, total hospitalization cost, readmission rate, and postoperative nursing quality were compared between these 2 groups.

RESULTS:

The intervention and control groups showed no significant differences in age, gender, and body mass index. Compared with the control group, the intervention group had a significantly lower incidence of postoperative pulmonary infection and gastrointestinal (GI) bleeding (27.6% vs. 14.7% and 31.0% vs. 15.7%, respectively, both P<0.05). Compared to the control group, the intervention group had significantly lower hospitalization costs, length of hospital stay, and readmission rate 30 days after discharge (32.98±9.10 vs. 36.78±15.36, 26.47±13.4 vs. 31.03±11.61 and 31.4% vs. 50.0%, respectively, all P<0.05). Additionally, the intervention group had significantly better quality of postoperative nursing care than the control group (11.61±0.69 vs. 9.64±1.42, P<0.01), the availability of infection control and prevention measures (11.74±0.61 vs. 10.53±1.11, P<0.01), the effectiveness of health education (11.73±0.61 vs. 10.41±1.06, P<0.01), the effectiveness of rehabilitation training (11.77±0.54 vs. 10.37±0.96, P<0.01), and the patient satisfaction with nursing care (11.83±0.42 vs. 10.81±1.08, P<0.01).

CONCLUSIONS:

The nurse-led MDT model for transplant patients can reduce complications, shorten hospital stays, and save costs. It also provides clear guidelines for nurses, improving care quality and aiding patient recovery.

TRIAL REGISTRATION:

Chinese Clinical Trial Registry ChiCTR1900026543.

  • Tang J
  • He R
  • Zhang L
  • Xu S
Ann Transplant. 2023 May 23;28:e940211 doi: 10.12659/AOT.940211.
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 randomised controlled trial in anaesthesia for simultaneous kidney-pancreas transplantation. Reversal of neuromuscular blockade with sugammadex is compared to neostigmine. There is great detail in the methods regarding the anaesthetic procedures and processes but there is no description of the randomisation or blinding. The study was powered for a significant improvement in the number of patients reaching TOFratio >0.9 within 40 minutes (essentially the reversal of neuromuscular blockade). There was a significantly faster reversal of neuromuscular blockade with sugammadex administration than neostigmine (median 3 minutes versus median 12 minutes). Time to extubation and length of PACU stay were also significantly reduced. There were no safety concerns in terms of renal function or other complications, but only 7 days follow up is reported.
Aims: The aim of this study was to determine the effect of sugammadex in simultanous pancreas-kidney (SPK) transplant recipients.
Interventions: Participants were randomised to receive either a sugammadex injection or the neostigmine-atropine complex.
Participants: 50 SPK transplant recipients.
Outcomes: The main outcomes of interest included assessment of blood glucose, serum creatinine, creatinine clearance rate, mean arterial pressure, serum amylase, heart rate, time from sugammadex/neostigmine administration at the scheduled time to recovery, and post-acute pulmonary complications.
Follow Up: 108 hours following surgery

BACKGROUND Simultaneous pancreas-kidney transplantation (SPK) is a time-consuming and important surgical procedure, which can provide a physiological mean of achieving normoglycemia and render patients free of dialysis. The potential clinical benefits of sugammadex include fast and predictable reverse deep neuromuscular blockade (NMB), but whether sugammadex affects the function of SPK grafts is uncertain. MATERIAL AND METHODS Forty-eight patients were studied and reversed deep NMB with either sugammadex (n=24) or neostigmine (n=24). The safety variables included serum creatinine (Scr), creatinine clearance rate (CCr), serum amylase (AMS), blood glucose (Glu), mean arterial pressure (MAP), and heart rate (HR). Secondary outcomes were time from administration of sugammadex/neostigmine at the scheduled time to recovery of a TOF ratio to 0.7 and 0.9, and post-acute pulmonary complications. RESULTS Scr at T2-6 was significantly lower than that at T0-1 (P<0.01), while CCr was higher (P<0.05). Between the 2 groups, Scr, CCr, and AMS were similar at the same timepoints (P>0.05). MAP, HR, and Glu were higher in group S than in group N at T1 (P<0.05). The recovery time of TOF=0.7 was 3 (2.4-4.2) min for group S and 12.1 (10.2-15.9) min for group N (P<0.001), and recovery time to TOFr ≥0.9 was 4.8 (3.6-7.1) min for group S and 23.5 (19.8-30.8) in group S. Compared to group N, group S had lower risk for post-acute pulmonary complications: supplemental oxygen requirements 0 vs 4 (16.7%), pulmonary atelectasis 0 vs 2 (0.83%), pneumonia 1 (4.2%) vs 3 (12.5%), and hypoxemia 1 (4.2%) vs 4 (16.7%). CONCLUSIONS Sugammadex administration is safe and effective for SPK transplantation recipients.

  • Ai Li E
  • Farrokhi K
  • Zhang MY
  • Offerni J
  • Luke PP
  • et al.
Transpl Int. 2023 Feb 1;36:10442 doi: 10.3389/ti.2023.10442.
CET Conclusion
Reviewer: Reshma Rana Magar, Centre for Evidence in Transplantation, Nuffield Department of Surgical Sciences University of Oxford
Conclusion: This systematic review and meta-analysis investigated the role of heparin thromboprophylaxis in simultaneous pancreas-kidney (SPK) transplantation, pancreas after kidney (PAK) transplantation and pancreas transplant alone (PTA). Study selection and data extraction were performed in duplicate. Only 11 studies, all of which were retrospective, were included. However, all the included studies were considered high quality (MINORS score > 60%). The authors found that heparin thromboprophylaxis reduced early pancreas thrombosis and pancreas loss by over two-folds for SPK, PAK and PTA, without resulting in an increase in the incidence of bleeding or acute return to the operating room. Heterogeneity was high for some of the outcomes but was not explored. No adjustments for confounders were made in the analyses.
Expert Review
Reviewer: Mr Simon Knight, Centre for Evidence in Transplantation, Nuffield Department of Surgical Sciences University of Oxford
Clinical Impact Rating 2
Review: Graft thrombosis is a recognised and feared complication of pancreas transplantation, resulting from a thromboinflammatory response and relatively low flow through the graft (1). It is more frequently seen in circulatory death (DCD) grafts and following pancreas transplant alone (PTA) compared to simultaneous pancreas kidney transplant (SPK) (1,2). Most centres employ some form of anticoagulation protocol in the peri-operative period to reduce the risk of thrombosis, although exact protocols vary considerably, and the evidence-base is limited. Use of anticoagulation is often monitored and adjusted using measures such as the activated partial thromboplastin clotting time (APTT) or thromboelastogram (TEG), with limited evidence that TEG monitoring may be beneficial (3,4). In their recent systematic review, Ai Li et al. attempt to summarise the literature regarding heparin thromboprophylaxis following pancreas transplantation (5). They identified 11 studies investigating heparin use in SPK and PTA recipients, of which just 4 were comparative and none were prospective. They conclude that heparinization significantly decreases the risk of early pancreatic thrombosis and graft loss due to thrombosis, with no evidence of increased bleeding or reoperation risk. Whilst the limited amount of observational data published in the literature does appear to support this conclusion overall, there are significant limitations to this study. There is no randomised controlled trial evidence available, and very limited comparative data meaning that the authors resort to comparing single-arm observational data to the control cohorts of other studies. Given the differences in protocols and surgical techniques between centres, the validity of this is uncertain. Even in the four comparative studies, there is significant heterogeneity in treatment protocols and monitoring strategies, meaning that the optimum regimen is unclear. The authors employ fixed effects methods in some of their meta-analysis. Given the heterogeneous and observational nature of the data, the assumptions of a fixed effects analysis are probably not met. Indeed, re-analysis using a random effects model increases uncertainty and loses the significant treatment effects seen in fixed effects analysis. It is unlikely that there is enough equipoise to undertake a large RCT of heparin versus no heparin following pancreas transplantation as most centres now use some form of anticoagulation. However, there is scope for future studies to investigate the optimal protocol and monitoring strategy for anticoagulation, including the use of TEG monitoring.
Aims: This study aimed to assess the effect of heparin thromboprophylaxis in simultaneous pancreas-kidney (SPK) transplantation, pancreas after kidney (PAK) transplantation and pancreas transplant alone (PTA).
Interventions: A literature search was performed on PubMed, EMBASE, BIOSIS, MEDLINE, Cochrane Library and Web of Science. Two reviewers independently selected studies for inclusion and extracted the data. Risk of bias was assessed using the Methodological Index for Non-Randomized Studies (MINORS).
Participants: 11 studies were included in the review.
Outcomes: Outcomes of interest were pancreas thrombosis during early post-transplant period, incidence of postoperative bleeding, pancreas graft loss due to thrombosis, acute return to the operating room, and units of packed red blood cells (pRBC) used.
Follow Up: N/A

Thrombosis is a leading causes of pancreas graft loss after simultaneous pancreas kidney (SPK), pancreas after kidney (PAK), and pancreas transplant alone (PTA). There remains no standardized thromboprophylaxis protocol. The aim of this systematic review and meta-analysis is to evaluate the impact of heparin thromboprophylaxis on the incidence of pancreas thrombosis, pancreas graft loss, bleeding, and secondary outcomes in SPK, PAK, and PTA. Following PRISMA guidelines, we systematically searched BIOSIS®, PubMed®, Cochrane Library®, EMBASE®, MEDLINE®, and Web of Science® on April 21, 2021. Primary peer-reviewed studies that met inclusion criteria were included. Two methods of quantitative synthesis were performed to account for comparative and non-comparative studies. We included 11 studies, comprising of 1,122 patients in the heparin group and 236 patients in the no-heparin group. When compared to the no-heparin control, prophylactic heparinization significantly decreased the risk of early pancreas thrombosis and pancreas loss for SPK, PAK and PTA without increasing the incidence of bleeding or acute return to the operating room. Heparin thromboprophylaxis yields an approximate two-fold reduction in both pancreas thrombosis and pancreas loss for SPK, PAK and PTA. We report the dosage, frequency, and duration of heparin administration to consolidate the available evidence.

  • Shepherd L
  • O'Carroll RE
  • Ferguson E
Soc Sci Med. 2023 Jan;317:115545 doi: 10.1016/j.socscimed.2022.115545.
CET Conclusion
Reviewer: Reshma Rana Magar, Centre for Evidence in Transplantation, Nuffield Department of Surgical Sciences University of Oxford
Conclusion: This study aimed to establish whether factors such as anticipated regret, the deceased wishes and next-of-kin attitudes could predict next-of-kin approval for organ donation, and to develop a model of next-of-kin decision making regarding organ donation in Wales, UK, which has an opt-out system. A total of 808 participants were randomly assigned to imagine whether a deceased relative had either opted-in, opted-out or had not registered a decision (deemed consent). The authors concluded that anticipated regret significantly influenced the next-of-kin approval for organ donation, and also that if the next-of kin had negative beliefs towards organ donation, they were less likely to follow the deceased wishes to donate. It is possible that the participants may have underestimated the influence of their emotions on future decision-making process; thus, how they believed they would act may be different from how they behave in real life. The authors do a good job of acknowledging this. However, the study did not assess ethnicity or religion, both of which have been found to affect the decision of the next-of-kin on organ donation. These could have acted as potential confounders in the analyses. Perhaps another factor the authors could have also considered is the type of relationship between the deceased donor and the next-of-kin. It would have been interesting to see if relatives with negative attitude towards organ donation were able to override their beliefs and follow the deceased donor’s wishes to donate if the deceased donor was an authority figure or a final decision maker when alive. For example, in cultures where fathers are the main decision makers, there may be a higher chance of sons/daughters respecting their deceased father’s wishes to donate despite their negative affective attitudes, in comparison to fathers respecting their deceased children’s wishes.
Aims: This study aimed to investigate how the deceased donor’s wishes, negative affective attitudes, perceived benefits and anticipated regret had an effect on the next-of-kin’s approval of organ donation under opt-out legislation.
Interventions: Participants were randomised to imagine if their deceased relative had either opted in, opted-out or not registered a decision (deemed consent).
Participants: Adults (≥18 years) living in Wales.
Outcomes: The outcome variables of interest included previous health-based philanthropy, uncertainty, anticipated regret, intention of next-of-kin to approve donation of organs, negative affective attitudes and perceived benefits.
Follow Up: Not reported
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.