68 results on '"Pengel, L"'
Search Results
2. Equity, Diversity and Inclusion (EDI) in Organ Transplantation:An ESOT Survey About EDI Within ESOT as an Organization and its Educational Activities, and Transplantation Research and Science
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Pengel, L. H.M., Kaisar, M., Benjamens, S., Ibrahim, M., Ricci, V., Bellini, M. I., Breithaupt-Faloppa, A. C., Falk, C., Maple, H., Marson, L., Ortiz, F., Papalois, V., Paredes, D., Forsberg, A., Pengel, L. H.M., Kaisar, M., Benjamens, S., Ibrahim, M., Ricci, V., Bellini, M. I., Breithaupt-Faloppa, A. C., Falk, C., Maple, H., Marson, L., Ortiz, F., Papalois, V., Paredes, D., and Forsberg, A.
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The European Society of Organ Transplantation (ESOT) strives to promote equity, diversity, and inclusion (EDI) across all its activities. We surveyed the transplant community’s experiences and perspectives regarding EDI within ESOT as an organization and its educational activities, and research in general. A total of 299 respondents completed the questionnaire. About half agreed that ESOT’s Executive Committee, Council, and Sections/Committees are diverse and inclusive (51%) and that ESOT promotes EDI in its live and digital educational activities (54%). Forty percent of respondents agreed that scientific and clinical trials in the field of transplantation are diverse and inclusive. Despite the wide distribution of the survey, most of the respondents self-identified as White and were either physician or surgeon. However, the results contribute a unique insight into the experiences and perspectives of the transplantation community regarding EDI. Whilst ESOT is committed to the principles of EDI, perceptions and the high number of proposals show the apparent need to prioritize efforts to embed EDI across ESOT and transplantation science. These data should constitute a starting point for change and provide guidance for future efforts to promote EDI within the transplantation community.
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- 2023
3. Post living kidney donation risk in relation to the donor baseline demographic characteristics: a systematic review and meta-analysis
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Bellini, MI, Nozdrin, M, Pengel, L, Knight, S, and Papalois, V
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Introduction: Living kidney donation risk is likely to differ according to donor’s demographic characteristics. Methods: Systematic review and meta-analysis of the effects of age, sex, body mass index (BMI) and ethnicity on donor’s kidney function, end stage renal disease (ESRD) incidence, survival, proteinuria, hypertension, and surgical complications. Results: 5129 studies were identified, 31 meeting the inclusion criteria, mainly from USA and Europe. Donors aged > 60 years had on average 9.54 ml/min/1.73m2 lower eGFR compared to younger donors(p30 was found to significantly lower donor’s eGFR 1-year post-donation: on average the eGFR of obese donors was 2.7 ml/min/1.7m2 lower (95%CI: -3.24 to -2.15 p Conclusion: Obesity and male sex were associated with inferior outcomes. Post-donation, donors aged>60 increased their eGFR gap, compared to younger donors. African donors had a higher incidence of ESRD compared to Caucasian donors. BMI lowers eGFR post-donation, although the clinical significance is minimal.
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- 2022
4. Proposed Definitions of Antibody-Mediated Rejection for Use as a Clinical Trial Endpoint in Kidney Transplantation
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Roufosse, C., Becker, J.U., Rabant, M., Seron, D., Bellini, M.I., Böhmig, G.A., Budde, K., Diekmann, F., Glotz, D., Hilbrands, L.B., Loupy, A., Oberbauer, R., Pengel, L., Schneeberger, S., Naesens, M., Roufosse, C., Becker, J.U., Rabant, M., Seron, D., Bellini, M.I., Böhmig, G.A., Budde, K., Diekmann, F., Glotz, D., Hilbrands, L.B., Loupy, A., Oberbauer, R., Pengel, L., Schneeberger, S., and Naesens, M.
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Item does not contain fulltext, Antibody-mediated rejection (AMR) is caused by antibodies that recognize donor human leukocyte antigen (HLA) or other targets. As knowledge of AMR pathophysiology has increased, a combination of factors is necessary to confirm the diagnosis and phenotype. However, frequent modifications to the AMR definition have made it difficult to compare data and evaluate associations between AMR and graft outcome. The present paper was developed following a Broad Scientific Advice request from the European Society for Organ Transplantation (ESOT) to the European Medicines Agency (EMA), which explored whether updating guidelines on clinical trial endpoints would encourage innovations in kidney transplantation research. ESOT considers that an AMR diagnosis must be based on a combination of histopathological factors and presence of donor-specific HLA antibodies in the recipient. Evidence for associations between individual features of AMR and impaired graft outcome is noted for microvascular inflammation scores ≥2 and glomerular basement membrane splitting of >10% of the entire tuft in the most severely affected glomerulus. Together, these should form the basis for AMR-related endpoints in clinical trials of kidney transplantation, although modifications and restrictions to the Banff diagnostic definition of AMR are proposed for this purpose. The EMA provided recommendations based on this Broad Scientific Advice request in December 2020; further discussion, and consensus on the restricted definition of the AMR endpoint, is required.
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- 2022
5. Surrogate Endpoints for Late Kidney Transplantation Failure
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Naesens, M., Budde, K., Hilbrands, L.B., Oberbauer, R., Bellini, M.I., Glotz, D., Grinyó, J., Heemann, U., Jochmans, I., Pengel, L., Reinders, M., Schneeberger, S., Loupy, A., Naesens, M., Budde, K., Hilbrands, L.B., Oberbauer, R., Bellini, M.I., Glotz, D., Grinyó, J., Heemann, U., Jochmans, I., Pengel, L., Reinders, M., Schneeberger, S., and Loupy, A.
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Contains fulltext : 252106.pdf (Publisher’s version ) (Open Access), In kidney transplant recipients, late graft failure is often multifactorial. In addition, primary endpoints in kidney transplantation studies seek to demonstrate the short-term efficacy and safety of clinical interventions. Although such endpoints might demonstrate short-term improvement in specific aspects of graft function or incidence of rejection, such findings do not automatically translate into meaningful long-term graft survival benefits. Combining many factors into a well-validated model is therefore more likely to predict long-term outcome and better reflect the complexity of late graft failure than using single endpoints. If conditional marketing authorization could be considered for therapies that aim to improve long-term outcomes following kidney transplantation, then the surrogate endpoint for graft failure in clinical trial settings needs clearer definition. This Consensus Report considers the potential benefits and drawbacks of several candidate surrogate endpoints (including estimated glomerular filtration rate, proteinuria, histological lesions, and donor-specific anti-human leukocyte antigen antibodies) and composite scoring systems. The content was created from information prepared by a working group within the European Society for Organ Transplantation (ESOT). The group submitted a Broad Scientific Advice request to the European Medicines Agency (EMA), June 2020: the request focused on clinical trial design and endpoints in kidney transplantation. Following discussion and refinement, the EMA made final recommendations to ESOT in December 2020 regarding the potential to use surrogate endpoints in clinical studies that aim to improving late graft failure.
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- 2022
6. Allograft Function as Endpoint for Clinical Trials in Kidney Transplantation
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Hilbrands, L.B., Budde, K., Bellini, M.I., Diekmann, F., Furian, L., Grinyó, J., Heemann, U., Hesselink, D.A., Loupy, A., Oberbauer, R., Pengel, L., Reinders, M., Schneeberger, S., Naesens, M., Hilbrands, L.B., Budde, K., Bellini, M.I., Diekmann, F., Furian, L., Grinyó, J., Heemann, U., Hesselink, D.A., Loupy, A., Oberbauer, R., Pengel, L., Reinders, M., Schneeberger, S., and Naesens, M.
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Contains fulltext : 252052.pdf (Publisher’s version ) (Open Access), Clinical study endpoints that assess the efficacy of interventions in patients with chronic renal insufficiency can be adopted for use in kidney transplantation trials, given the pathophysiological similarities between both conditions. Kidney dysfunction is reflected in the glomerular filtration rate (GFR), and although a predefined (e.g., 50%) reduction in GFR was recommended as an endpoint by the European Medicines Agency (EMA) in 2016, many other endpoints are also included in clinical trials. End-stage renal disease is strongly associated with a change in estimated (e)GFR, and eGFR trajectories or slopes are increasingly used as endpoints in clinical intervention trials in chronic kidney disease (CKD). Similar approaches could be considered for clinical trials in kidney transplantation, although several factors should be taken into account. The present Consensus Report was developed from documentation produced by the European Society for Organ Transplantation (ESOT) as part of a Broad Scientific Advice request that ESOT submitted to the EMA in 2020. This paper provides a contemporary discussion of primary endpoints used in clinical trials involving CKD, including proteinuria and albuminuria, and evaluates the validity of these concepts as endpoints for clinical trials in kidney transplantation.
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- 2022
7. Rationale for Surrogate Endpoints and Conditional Marketing Authorization of New Therapies for Kidney Transplantation
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Naesens, M., Loupy, A., Hilbrands, L.B., Oberbauer, R., Bellini, M.I., Glotz, D., Grinyó, J., Heemann, U., Jochmans, I., Pengel, L., Reinders, M., Schneeberger, S., Budde, K., Naesens, M., Loupy, A., Hilbrands, L.B., Oberbauer, R., Bellini, M.I., Glotz, D., Grinyó, J., Heemann, U., Jochmans, I., Pengel, L., Reinders, M., Schneeberger, S., and Budde, K.
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Contains fulltext : 252103.pdf (Publisher’s version ) (Open Access), Conditional marketing authorization (CMA) facilitates timely access to new drugs for illnesses with unmet clinical needs, such as late graft failure after kidney transplantation. Late graft failure remains a serious, burdensome, and life-threatening condition for recipients. This article has been developed from content prepared by members of a working group within the European Society for Organ Transplantation (ESOT) for a Broad Scientific Advice request, submitted by ESOT to the European Medicines Agency (EMA), and reviewed by the EMA in 2020. The article presents the rationale for using surrogate endpoints in clinical trials aiming at improving late graft failure rates, to enable novel kidney transplantation therapies to be considered for CMA and improve access to medicines. The paper also provides background data to illustrate the relationship between primary and surrogate endpoints. Developing surrogate endpoints and a CMA strategy could be particularly beneficial for studies where the use of primary endpoints would yield insufficient statistical power or insufficient indication of long-term benefit following transplantation.
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- 2022
8. Proposed Definitions of T Cell-Mediated Rejection and Tubulointerstitial Inflammation as Clinical Trial Endpoints in Kidney Transplantation
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Seron, D., Rabant, M., Becker, J.U., Roufosse, C., Bellini, M.I., Böhmig, G.A., Budde, K., Diekmann, F., Glotz, D., Hilbrands, L.B., Loupy, A., Oberbauer, R., Pengel, L., Schneeberger, S., Naesens, M., Seron, D., Rabant, M., Becker, J.U., Roufosse, C., Bellini, M.I., Böhmig, G.A., Budde, K., Diekmann, F., Glotz, D., Hilbrands, L.B., Loupy, A., Oberbauer, R., Pengel, L., Schneeberger, S., and Naesens, M.
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Contains fulltext : 252101.pdf (Publisher’s version ) (Open Access), The diagnosis of acute T cell-mediated rejection (aTCMR) after kidney transplantation has considerable relevance for research purposes. Its definition is primarily based on tubulointerstitial inflammation and has changed little over time; aTCMR is therefore a suitable parameter for longitudinal data comparisons. In addition, because aTCMR is managed with antirejection therapies that carry additional risks, anxieties, and costs, it is a clinically meaningful endpoint for studies. This paper reviews the history and classifications of TCMR and characterizes its potential role in clinical trials: a role that largely depends on the nature of the biopsy taken (indication vs protocol), the level of inflammation observed (e.g., borderline changes vs full TCMR), concomitant chronic lesions (chronic active TCMR), and the therapeutic intervention planned. There is ongoing variability-and ambiguity-in clinical monitoring and management of TCMR. More research, to investigate the clinical relevance of borderline changes (especially in protocol biopsies) and effective therapeutic strategies that improve graft survival rates with minimal patient morbidity, is urgently required. The present paper was developed from documentation produced by the European Society for Organ Transplantation (ESOT) as part of a Broad Scientific Advice request that ESOT submitted to the European Medicines Agency for discussion in 2020. This paper proposes to move toward refined definitions of aTCMR and borderline changes to be included as primary endpoints in clinical trials of kidney transplantation.
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- 2022
9. A comparison of ECG-based home monitoring devices in adults with congenital heart disease
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Bokma, J P, primary, Pengel, L K D, additional, Robbers-Visser, D, additional, Groenink, M, additional, Boekholdt, S M, additional, and Bouma, B J, additional
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- 2021
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10. What Is The Evidence For Oxygenated Hypothermic Machine Perfusion in Kidney Transplantation? A Systematic Review*.: Abstract# D2684
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Pall, K., OʼCallaghan, J., and Pengel, L.
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- 2014
11. COVID‐19 and education: restructuring after the pandemic
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Bellini, MI, Pengel, L, Potena, L, Segantini, L, and Group, ESOT COVID‐19 Working
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2019-20 coronavirus outbreak ,medicine.medical_specialty ,Biomedical Research ,Coronavirus disease 2019 (COVID-19) ,Restructuring ,Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) ,Physical Distancing ,webinar ,Disease ,Review Article ,030230 surgery ,COVID-19 ,education ,pandemic ,telemedicine ,Global Health ,Specialties, Surgical ,Education, Distance ,03 medical and health sciences ,0302 clinical medicine ,COVID‐19 ,Pandemic ,medicine ,Humans ,Review Articles ,Pandemics ,Transplantation ,business.industry ,SARS-CoV-2 ,Death toll ,Italy ,Family medicine ,030211 gastroenterology & hepatology ,Periodicals as Topic ,business - Abstract
COVID-19 challenges to keep a valuable educational offer with lockdown measures and social distancing are reviewed. Scientific Societies had to think of new alternatives to maintain meetings with conversion to a virtual format and development of online resources, rapidly available and broadly accessible. Other in person activities as face-to-face clinics have been substituted by telemedicine; the same happened with surgical training in theatre, given the suspension of most of the operations. Finally, the need to share and communicate in a continuous evolving scenario, has impacted negatively the integrity of peer review process, not following the normal procedures to ensure scientific integrity and reproducibility in the earliest phases of the pandemic.
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- 2021
12. Systematic review of clinical practice guidelines in kidney transplantation
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O'Donoghue, K, Reed, R, Knight, S, O'Callaghan, J, Ayaz-Shah, A, Hassan, S, Morris, P, and Pengel, L
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animal structures ,Systematic Reviews ,embryonic structures ,Systematic Review ,human activities - Abstract
Background Clinical practice guidelines (CPGs) are widely used to inform the development of protocols for clinical management. Previous work has demonstrated that the quality of CPGs varies widely. This systematic review aimed to determine the quality of CPGs in kidney transplantation in the UK. Methods CPGs in kidney transplantation published between 2010 and 2017 were identified through searches of MEDLINE, NHS NICE Evidence, and websites of relevant UK societies. Using the Appraisal of Guidelines for Research and Evaluation (AGREE) II tool, three appraisers rated the quality of CPGs across six domains, the overall quality of each CPG, and whether it should be recommended for future use. Domain scores were calculated, and inter‐rater reliability using the intraclass correlation coefficient (ICC) was reported. Results Thirteen CPGs met the inclusion criteria. The domain ‘clarity of presentation’ scored highest, followed closely by ‘scope and purpose’. The poorest scoring domains were ‘applicability’ and ‘editorial independence’. Editorial independence also had the widest range of scores. Of the 13 CPGs, one was not recommended for future use, seven were recommended for use with modifications, and five for future use with no need for modification. Mean overall CPG quality was 5 (range 3–6) of a maximum score of 7, and mean inter‐rater reliability was substantial with an ICC of 0·71. Conclusion UK CPGs scored satisfactorily, although with wide variation in how well each domain scored both within and across CPGs. The quality of UK CPGs can still be improved.
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- 2018
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13. Critical appraisal of United Kingdom clinical practice guidelines in kidney transplantation using the Appraisal of Guidelines for Research and Education (AGREE) II tool: A systematic review
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Knight, SR, Pengel, L, O'Callaghan, J, and Morris, P
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musculoskeletal diseases - Abstract
Purpose Patient specific instrumentation (PSI) has been proposed as a means of improving surgical accuracy and ease of implantation during technically challenging procedures such as unicompartmental knee arthroplasty (UKA). The purpose of this prospective randomised controlled trial (RCT) was to compare the accuracy of implantation and functional outcome of mobile bearing medial UKA s implanted with and without PSI by experienced UKA surgeons. Methods Mobile-bearing medial UKA s implanted were implanted in 43 patients using either PSI guides or conventional instrumentation. Intra-operative measurements, meniscal bearing size implanted, and post-operative radiographic analyses were performed to assess component positioning. Functional outcome was determined using the Oxford Knee Score (OKS). Results PSI guides could not be used in 3 cases due to concerns regarding accuracy and registration onto native anatomy, particularly on the tibial side. In general, similar component alignment and positioning was achieved using the two systems (n.s. for coronal/sagittal alignment and tibial coverage). The PSI group had greater tibial slope (p=0.029). The control group had a higher number of optimum size meniscal bearing inserted (95% versus 52%; p=0.001). There were no differences in OKS improvements (n.s). Conclusions Component positioning for the two groups was similar for the femur but less accurate on the tibial side using PSI, often with some unnecessarily deep resections of the tibial plateau. Although PSI was comparable to conventional instrumentation based on OKS improvements at 12-months, we continue to use conventional instrumentation for UKA at our institution until further improvements to the PSI guides can be demonstrated.
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- 2017
14. Safety of intraoperative blood salvage during liver transplantation in patients with hepatocellular carcinoma; systematic review and meta-analysis
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Rutten, V., primary, Aijtink, V., additional, Meijer, B., additional, Scalera, I., additional, Mihaylov, V., additional, Heikkila, K., additional, Pengel, L., additional, Perera, T., additional, and Hartog, H., additional
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- 2018
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15. Systematic review of clinical practice guidelines in kidney transplantation
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O'Donoghue, K. J. M., primary, Reed, R. D., additional, Knight, S. R., additional, O'Callaghan, J. M., additional, Ayaz-Shah, A. A., additional, Hassan, S., additional, Morris, P. J., additional, and Pengel, L. H. M., additional
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- 2017
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16. What Is The Evidence For Oxygenated Hypothermic Machine Perfusion in Kidney Transplantation? A Systematic Review*.
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Pall, K., primary, OʼCallaghan, J., additional, and Pengel, L., additional
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- 2014
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17. The Rate of Publication of Abstracts in Solid Organ Transplantation Presented at Scientific Meetings
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Zucker, K., primary, Pengel, L. H., additional, Liu, L. Q., additional, and Morris, P. J., additional
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- 2012
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18. QUALITY OF REPORTING OF RANDOMIZED CONTROLLED TRIALS IN SOLID ORGAN TRANSPLANTATION.
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Morris, P J., primary, Pengel, L H.M., additional, and Barcena, L, additional
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- 2008
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19. Acute low back pain: systematic review of its prognosis
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Pengel, L. H M, primary
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- 2003
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20. Past, Present, and Future of Dynamic Kidney and Liver Preservation and Resuscitation
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Jochmans, I., Akhtar, M. Z., Nasralla, D., Kocabayoglu, P., Boffa, C., Kaisar, M., Brat, A., O'Callaghan, J., Pengel, L. H. M., Knight, S., and Ploeg, R. J.
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The increased demand for organs has led to the increased usage of “higher risk” kidney and liver grafts. These grafts from donation after circulatory death or expanded criteria donors are more susceptible to preservation injury and have a higher risk of unfavorable outcomes. Dynamic, instead of static, preservation could allow for organ optimization, offering a platform for viability assessment, active organ repair and resuscitation. Ex situmachine perfusion and in situregional perfusion in the donor are emerging as potential tools to preserve and resuscitate vulnerable grafts. Preclinical findings have ignited clinical organ preservation research that investigates dynamic preservation, its various modes (continuous, preimplantation) and temperatures (hypo‐, sub, or normothermic). This review outlines the current status of dynamic preservation of kidney and liver grafts and describes ongoing research and emerging clinical trials. The authors summarize recent advances in the field of dynamic preservation of kidneys and livers, and detail ongoing and upcoming research that will advance the field.
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- 2016
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21. Physiotherapist-directed exercise, advice, or both for subacute low back pain: A randomized trial
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Pengel, L. H. M., Refshauge, K. M., Maher, C. G., Nicholas, M. K., Rob Herbert, and Mcnair, P.
22. Acute low back pain: Systematic review of its prognosis
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Pengel, L. H. M., Rob Herbert, Maher, C. G., and Refshauge, K. M.
23. European Guideline for the Management of Kidney Transplant Patients With HLA Antibodies: By the European Society for Organ Transplantation Working Group
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Mamode, Nizam, Bestard, Oriol, Claas, Frans, Furian, Lucrezia, Griffin, Sian, Legendre, Christophe, Pengel, Liset, Naesens, Maarten, Institut Català de la Salut, [Mamode N] Department of Transplantation, Guys Hospital, London, United Kingdom. [Bestard O] Grup de Recerca en Nefrologia i Trasplantament Renal, Vall d’Hebron Hospital Universitari, Barcelona, Spain. [Claas F] Department of Immunology, Leiden University Medical Center, Leiden, Netherlands. Department of Immunology, University of Antwerp, Antwerp, Belgium. [Furian L] Kidney and Pancreas Transplantation Unit, Department of Surgical Gastroenterological and Oncological Sciences, University Hospital of Padua, Padua, Italy. [Griffin S] Department of Nephrology, University Hospital of Wales, Cardiff, United Kingdom. [Legendre C] Department of Nephrology and Adult Kidney Transplantation, Hôpital Necker and Université de Paris, Paris, France. [Pengel L] Centre for Evidence in Transplantation, University of Oxford, Oxford, United Kingdom. [Naesens M] Department of Microbiology, Immunology and Transplantation, KU Leuven, Leuven, Belgium, and Vall d'Hebron Barcelona Hospital Campus
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Waiting Lists ,ALLOCATION SYSTEM ,Health Services Administration::Organization and Administration::Appointments and Schedules::Waiting Lists [HEALTH CARE] ,kidney transplantation ,PAIRED DONATION ,Antibodies ,técnicas de investigación::técnicas de investigación::técnicas inmunológicas::pruebas inmunológicas::pruebas de histocompatibilidad [TÉCNICAS Y EQUIPOS ANALÍTICOS, DIAGNÓSTICOS Y TERAPÉUTICOS] ,sensitization ,Hospitals - Llistes d'espera ,LONG-TERM OUTCOMES ,MEDIATED REJECTION ,HLA Antigens ,Therapeutics::Renal Replacement Therapy::Kidney Transplantation [ANALYTICAL, DIAGNOSTIC AND THERAPEUTIC TECHNIQUES, AND EQUIPMENT] ,Living Donors ,Humans ,DONOR-SPECIFIC ANTIBODIES ,HIGHLY SENSITIZED PATIENTS ,ASSAY ,guidelines ,Transplantation ,Science & Technology ,Histocompatibility Testing ,CROSS-MATCH TEST ,Ronyons - Trasplantació ,terapéutica::tratamiento de reemplazo renal::trasplante de riñón [TÉCNICAS Y EQUIPOS ANALÍTICOS, DIAGNÓSTICOS Y TERAPÉUTICOS] ,HLA antibodies ,incompatible ,Quality of Life ,Kidney Transplantation ,Investigative Techniques::Investigative Techniques::Immunologic Techniques::Immunologic Tests::Histocompatibility Testing [ANALYTICAL, DIAGNOSTIC AND THERAPEUTIC TECHNIQUES, AND EQUIPMENT] ,Surgery ,SURVIVAL BENEFIT ,Human medicine ,ACCESS ,Life Sciences & Biomedicine ,Complex major d'histocompatibilitat ,administración de los servicios de salud::organización y administración::citas y programación::listas de espera [ATENCIÓN DE SALUD] - Abstract
HLA antibodies; Guidelines; Incompatible Anticuerpos HLA; Pautas; Incompatible Anticossos HLA; Directrius; Incompatible This guideline, from a European Society of Organ Transplantation (ESOT) working group, concerns the management of kidney transplant patients with HLA antibodies. Sensitization should be defined using a virtual parameter such as calculated Reaction Frequency (cRF), which assesses HLA antibodies derived from the actual organ donor population. Highly sensitized patients should be prioritized in kidney allocation schemes and linking allocation schemes may increase opportunities. The use of the ENGAGE 5 ((Bestard et al., Transpl Int, 2021, 34: 1005–1018) system and online calculators for assessing risk is recommended. The Eurotransplant Acceptable Mismatch program should be extended. If strategies for finding a compatible kidney are very unlikely to yield a transplant, desensitization may be considered and should be performed with plasma exchange or immunoadsorption, supplemented with IViG and/or anti-CD20 antibody. Newer therapies, such as imlifidase, may offer alternatives. Few studies compare HLA incompatible transplantation with remaining on the waiting list, and comparisons of morbidity or quality of life do not exist. Kidney paired exchange programs (KEP) should be more widely used and should include unspecified and deceased donors, as well as compatible living donor pairs. The use of a KEP is preferred to desensitization, but highly sensitized patients should not be left on a KEP list indefinitely if the option of a direct incompatible transplant exists. The authors declare that this study received funding from Hansa Biopharma. The funder was not involved in the study design, collection, analysis, interpretation of data, the writing of this article or the decision to submit it for publication. Medical writing support was provided by Linda Edmondson and Rebecca Mant, independent medical writers, funded by the European Society of Organ Transplantation.
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- 2022
24. European Society for Organ Transplantation (ESOT)-TLJ 3.0 Consensus on Histopathological Analysis of Pre-Implantation Donor Kidney Biopsy: Redefining the Role in the Process of Graft Assessment.
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Zaza G, Cucchiari D, Becker JU, de Vries APJ, Eccher A, Florquin S, Kers J, Rabant M, Rossini M, Pengel L, Marson L, and Furian L
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- Humans, Reproducibility of Results, Kidney pathology, Biopsy, Tissue Donors, Graft Survival, Kidney Transplantation methods, Organ Transplantation
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The ESOT TLJ 3.0. consensus conference brought together leading experts in transplantation to develop evidence-based guidance on the standardization and clinical utility of pre-implantation kidney biopsy in the assessment of grafts from Expanded Criteria Donors (ECD). Seven themes were selected and underwent in-depth analysis after formulation of PICO (patient/population, intervention, comparison, outcomes) questions. After literature search, the statements for each key question were produced, rated according the GRADE approach [Quality of evidence: High (A), Moderate (B), Low (C); Strength of Recommendation: Strong (1), Weak (2)]. The statements were subsequently presented in-person at the Prague kick-off meeting, discussed and voted. After two rounds of discussion and voting, all 7 statements reached an overall agreement of 100% on the following issues: needle core/wedge/punch technique representatively [B,1], frozen/paraffin embedded section reliability [B,2], experienced/non-experienced on-call renal pathologist reproducibility/accuracy of the histological report [A,1], glomerulosclerosis/other parameters reproducibility [C,2], digital pathology/light microscopy in the measurement of histological variables [A,1], special stainings/Haematoxylin and Eosin alone comparison [A,1], glomerulosclerosis reliability versus other histological parameters to predict the graft survival, graft function, primary non-function [B,1]. This methodology has allowed to reach a full consensus among European experts on important technical topics regarding pre-implantation biopsy in the ECD graft assessment., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2023 Zaza, Cucchiari, Becker, de Vries, Eccher, Florquin, Kers, Rabant, Rossini, Pengel, Marson and Furian.)
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- 2023
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25. Does Exercise Training Improve Physical Fitness and Health in Adult Liver Transplant Recipients? A Systematic Review and Meta-analysis.
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De Smet S, O'Donoghue K, Lormans M, Monbaliu D, and Pengel L
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- Adult, Humans, Physical Fitness, Exercise, Muscle Strength physiology, Quality of Life, Liver Transplantation adverse effects, Resistance Training
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Background: The impaired physical fitness of end-stage liver disease patients often persists after liver transplantation (LT) and compromises posttransplant recovery. This systematic review and meta-analysis evaluated evidence supporting the potential of exercise training to improve physical fitness and health-related quality of life (HRQOL) after LT., Methods: Bibliographic searches identified all randomized controlled trials (RCTs) comparing aerobic and strength training versus usual care after LT. Risk of bias was assessed, and study outcomes measuring physical fitness and HRQOL were extracted. Meta-analysis was performed if at least 3 studies reported on an outcome., Results: Eight RCTs (n = 334) were identified. Methodological study quality varied and was poorly reported. Meta-analyses showed a trend for favorable effects of exercise on cardiorespiratory fitness (peak oxygen uptake or 6-min walking distance; 6 studies, n = 275; standardized mean difference: 0.23, 95% confidence interval [CI], -0.01 to 0.48) and of strength training either or not combined with aerobic training on muscular fitness (dynamometry-assessed muscle strength or 30-s sit-to-stand test; 3 studies, n = 114; standardized mean difference: 0.34, 95% CI, -0.03 to 0.72). A favorable effect was found for exercise on the Short-Form Health Survey-36 HRQOL physical function subcomponent (3 studies, n = 194; mean difference: 9.1, 95% CI, 0.3-17.8). No exercise-related adverse events were observed., Conclusions: RCTs indicate that exercise training in LT recipients is safe, improves physical function aspects of HRQOL, and may benefit cardiorespiratory and muscular fitness. The strength of evidence is, however, limited by the low number of patients and study quality. More adequately powered, high-quality RCTs are warranted., Competing Interests: The authors declare no conflicts of interest., (Copyright © 2022 Wolters Kluwer Health, Inc. All rights reserved.)
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- 2023
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26. ESOT Consensus Platform for Organ Transplantation: Setting the Stage for a Rigorous, Regularly Updated Development Process.
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Cillo U, Weissenbacher A, Pengel L, Jochmans I, Roppolo D, Amarelli C, Belli LS, Berenguer M, De Vries A, Ferrer J, Friedewald J, Furian L, Greenwood S, Monbaliu D, Nadalin S, Neyrinck A, Strazzabosco M, Toso C, Zaza G, Thuraisingham R, Berney T, Potena L, Montserrat N, and Selzner N
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- Humans, Consensus, Societies, Medical, Organ Transplantation
- Abstract
The European Society for Organ Transplantation (ESOT) has created a platform for the development of rigorous and regularly updated evidence based guidelines for clinical practice in the transplantation field. A dedicated Guideline Taskforce, including ESOT-council members, a representative from the Centre for Evidence in Transplantation, editors of the journal Transplant International has developed transparent procedures to guide the development of guidelines, recommendations, and consensus statements. During ESOT's first Consensus Conference in November 2022, leading experts will present in-depth evidence based reviews of nine themes and will propose recommendations aimed at reaching a consensus after public discussion and assessment by an independent jury. All recommendations and consensus statements produced for the nine selected topics will be published including the entire evidence-based consensus-finding process. An extensive literature review of each topic was conducted to provide final evidence and/or expert opinion., Competing Interests: IJ received speaker fees from XVIVO perfusion paid to her institution. IJ is an ESOT Councilor for which she receives no reimbursement. JFe is recipient of a grant supported by Instituto de Salud Carlos III (ISCIII) through the project “PI18/00161 (Optimization of pancreas transplant graft: A multicentric study of histo-morphological and functional characteristics of unaccepted organs.)” and co-funded by the European Union. AdV received in the past speaker and consultation fees from Astellas, Chiesi, Hansa, Novartis, Sandoz, CSL Behring all of which paid to his institution. AdV is chair of the Dutch Kidney Advisory Committee (Landelijk Overleg NierTransplantatie LONT) for which he receives no reimbursement. The remaining authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2022 Cillo, Weissenbacher, Pengel, Jochmans, Roppolo, Amarelli, Belli, Berenguer, De Vries, Ferrer, Friedewald, Furian, Greenwood, Monbaliu, Nadalin, Neyrinck, Strazzabosco, Toso, Zaza, Thuraisingham, Berney, Potena, Montserrat and Selzner.)
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- 2022
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27. European Guideline for the Management of Kidney Transplant Patients With HLA Antibodies: By the European Society for Organ Transplantation Working Group.
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Mamode N, Bestard O, Claas F, Furian L, Griffin S, Legendre C, Pengel L, and Naesens M
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- Antibodies, HLA Antigens, Histocompatibility Testing, Humans, Living Donors, Quality of Life, Waiting Lists, Kidney Transplantation
- Abstract
This guideline, from a European Society of Organ Transplantation (ESOT) working group, concerns the management of kidney transplant patients with HLA antibodies. Sensitization should be defined using a virtual parameter such as calculated Reaction Frequency (cRF), which assesses HLA antibodies derived from the actual organ donor population. Highly sensitized patients should be prioritized in kidney allocation schemes and linking allocation schemes may increase opportunities. The use of the ENGAGE 5 ((Bestard et al., Transpl Int, 2021, 34: 1005-1018) system and online calculators for assessing risk is recommended. The Eurotransplant Acceptable Mismatch program should be extended. If strategies for finding a compatible kidney are very unlikely to yield a transplant, desensitization may be considered and should be performed with plasma exchange or immunoadsorption, supplemented with IViG and/or anti-CD20 antibody. Newer therapies, such as imlifidase, may offer alternatives. Few studies compare HLA incompatible transplantation with remaining on the waiting list, and comparisons of morbidity or quality of life do not exist. Kidney paired exchange programs (KEP) should be more widely used and should include unspecified and deceased donors, as well as compatible living donor pairs. The use of a KEP is preferred to desensitization, but highly sensitized patients should not be left on a KEP list indefinitely if the option of a direct incompatible transplant exists., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2022 Mamode, Bestard, Claas, Furian, Griffin, Legendre, Pengel and Naesens.)
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- 2022
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28. Risks for donors associated with living kidney donation: meta-analysis.
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Bellini MI, Nozdrin M, Pengel L, Knight S, and Papalois V
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- Aged, Female, Glomerular Filtration Rate, Humans, Kidney, Living Donors, Male, Nephrectomy adverse effects, Obesity complications, Retrospective Studies, Time Factors, Hypertension epidemiology, Kidney Failure, Chronic complications, Kidney Failure, Chronic epidemiology, Kidney Failure, Chronic surgery, Kidney Transplantation
- Abstract
Background: Living kidney donation risk is likely to differ according to donor's demographics. We aimed to analyse the effects of age, sex, body mass index (BMI) and ethnicity., Methods: A systematic review and meta-analysis was undertaken of the effects of preoperative patient characteristics on donor kidney function outcomes, surgical complications, and hypertension., Results: 5129 studies were identified, of which 31 met the inclusion criteria, mainly from the USA and Europe. The estimated glomerular filtration rate (eGFR) in donors aged over 60 years was a mean of 9.54 ml per min per 1.73 m2 lower than that of younger donors (P < 0.001). Female donors had higher relative short- and long-term survival. BMI of over 30 kg/m2 was found to significantly lower the donor's eGFR 1 year after donation: the eGFR of obese donors was lower than that of non-obese patients by a mean of -2.70 (95 per cent c.i. -3.24 to -2.15) ml per min per 1.73 m2 (P < 0.001). Obesity was also associated with higher blood pressure both before and 1 year after donation, and a higher level of proteinuria, but had no impact on operative complications. In the long term, African donors were more likely to develop end-stage renal disease than Caucasians., Conclusion: Obesity and male sex were associated with inferior outcomes. Older donors (aged over 60 years) have a larger eGFR decline than younger donors, and African donors have a higher incidence of ESRD than Caucasians., (© The Author(s) 2022. Published by Oxford University Press on behalf of BJS Society Ltd.)
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- 2022
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29. Allograft Function as Endpoint for Clinical Trials in Kidney Transplantation.
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Hilbrands L, Budde K, Bellini MI, Diekmann F, Furian L, Grinyó J, Heemann U, Hesselink DA, Loupy A, Oberbauer R, Pengel L, Reinders M, Schneeberger S, and Naesens M
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- Albuminuria, Allografts, Disease Progression, Glomerular Filtration Rate, Humans, Kidney Transplantation, Renal Insufficiency, Chronic
- Abstract
Clinical study endpoints that assess the efficacy of interventions in patients with chronic renal insufficiency can be adopted for use in kidney transplantation trials, given the pathophysiological similarities between both conditions. Kidney dysfunction is reflected in the glomerular filtration rate (GFR), and although a predefined (e.g., 50%) reduction in GFR was recommended as an endpoint by the European Medicines Agency (EMA) in 2016, many other endpoints are also included in clinical trials. End-stage renal disease is strongly associated with a change in estimated (e)GFR, and eGFR trajectories or slopes are increasingly used as endpoints in clinical intervention trials in chronic kidney disease (CKD). Similar approaches could be considered for clinical trials in kidney transplantation, although several factors should be taken into account. The present Consensus Report was developed from documentation produced by the European Society for Organ Transplantation (ESOT) as part of a Broad Scientific Advice request that ESOT submitted to the EMA in 2020. This paper provides a contemporary discussion of primary endpoints used in clinical trials involving CKD, including proteinuria and albuminuria, and evaluates the validity of these concepts as endpoints for clinical trials in kidney transplantation., Competing Interests: LH reports speaker fees from Astellas, consultancy and research support from Chiesi, consultancy for Novartis, and research support from Sandoz. KB has received honoraria and/or research funding from Alexion, Astellas, Bristol Myers Squibb, Chiesi, Fresenius, Hansa, Hexal, Merck, Novartis, Otsuka, Pfizer, Roche, Sandoz, Siemens, and Veloxis. LF has received honoraria and/or research funding from Astellas, Chiesi, Hansa, and Novartis. JG consults for Sanofi. UH has received grants/research support from Baxter, Chiesi, and Neovii; speakers' bureaux/honoraria from Chiesi and Hansa; and consulting fees from Astellas, Hansa, Neovii, Novartis, and Teva. DH has received lecture fees and consulting fees from Astellas, Chiesi, MedinCell, Novartis, and Vifor; and grant support (paid to institution) from Astellas, Bristol Myers Squibb, and Chiesi. RO has received grants/research support from Amgen, Astellas, and Chiesi; and speakers' bureaux/honoraria from Amgen, Astellas, Chiesi, Hansa, Neovii, Novartis, and Teva. MR has received lecture fees from Astellas and Chiesi; and research grant support (paid to institution) from Astellas and Chiesi for investigator initiated studies. SS has received grants/research support from Bridge to Life, Chiesi, Neovii, Novartis, Organ Recovery Systems, and Sandoz; speakers' bureaux/honoraria from Astellas, BMS, Chiesi, Novartis, OrganOx, and Sanofi; and consulting fees from Astellas, Atara, Merck, NefroHealth, Novartis, Sandoz, and Teva. The remaining authors declare that the work was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2022 Hilbrands, Budde, Bellini, Diekmann, Furian, Grinyó, Heemann, Hesselink, Loupy, Oberbauer, Pengel, Reinders, Schneeberger and Naesens.)
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- 2022
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30. Proposed Definitions of T Cell-Mediated Rejection and Tubulointerstitial Inflammation as Clinical Trial Endpoints in Kidney Transplantation.
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Seron D, Rabant M, Becker JU, Roufosse C, Bellini MI, Böhmig GA, Budde K, Diekmann F, Glotz D, Hilbrands L, Loupy A, Oberbauer R, Pengel L, Schneeberger S, and Naesens M
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- Biopsy, Graft Rejection etiology, Humans, Inflammation pathology, Kidney pathology, T-Lymphocytes, Kidney Transplantation adverse effects, Kidney Transplantation methods
- Abstract
The diagnosis of acute T cell-mediated rejection (aTCMR) after kidney transplantation has considerable relevance for research purposes. Its definition is primarily based on tubulointerstitial inflammation and has changed little over time; aTCMR is therefore a suitable parameter for longitudinal data comparisons. In addition, because aTCMR is managed with antirejection therapies that carry additional risks, anxieties, and costs, it is a clinically meaningful endpoint for studies. This paper reviews the history and classifications of TCMR and characterizes its potential role in clinical trials: a role that largely depends on the nature of the biopsy taken (indication vs protocol), the level of inflammation observed (e.g., borderline changes vs full TCMR), concomitant chronic lesions (chronic active TCMR), and the therapeutic intervention planned. There is ongoing variability-and ambiguity-in clinical monitoring and management of TCMR. More research, to investigate the clinical relevance of borderline changes (especially in protocol biopsies) and effective therapeutic strategies that improve graft survival rates with minimal patient morbidity, is urgently required. The present paper was developed from documentation produced by the European Society for Organ Transplantation (ESOT) as part of a Broad Scientific Advice request that ESOT submitted to the European Medicines Agency for discussion in 2020. This paper proposes to move toward refined definitions of aTCMR and borderline changes to be included as primary endpoints in clinical trials of kidney transplantation., Competing Interests: MR has received lecture fees from Astellas and Chiesi; and research grant support (paid to institution) for investigator-initiated studies from Astellas and Chiesi. JB consults for Sanofi. GB has received honoraria and/or research funding from Astellas, CareDx, CSL Behring, Fresenius, Hansa, Neovii, and Vitaeris. KB has received honoraria and/or research funding from Alexion, Astellas, Bristol Myers Squibb, Chiesi, Fresenius, Hansa, Hexal, Merck, Novartis, Otsuka, Pfizer, Roche, Sandoz, Siemens, and Veloxis. DG reports consultancy agreements and scientific boards for AstraZeneca, BMS, Hansa, and Sanofi. LH reports speaker fees from Astellas, consultancy and research support from Chiesi, consultancy for Novartis, and research support from Sandoz. RO has received grants/research support from Amgen, Astellas, and Chiesi; and speakers’ bureaux/honoraria from Amgen, Astellas, Chiesi, Hansa, Neovii, Novartis, and Teva. SS has received grants/research support from Bridge to Life, Chiesi, Neovii, Novartis, Organ Recovery Systems, and Sandoz; speakers’ bureaux/honoraria from Astellas, BMS, Chiesi, Novartis, OrganOx, and Sanofi; and consulting fees from Astellas, Atara, Merck, NefroHealth, Novartis, Sandoz, and Teva. The remaining authors declare that the work was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2022 Seron, Rabant, Becker, Roufosse, Bellini, Böhmig, Budde, Diekmann, Glotz, Hilbrands, Loupy, Oberbauer, Pengel, Schneeberger and Naesens.)
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- 2022
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31. Rationale for Surrogate Endpoints and Conditional Marketing Authorization of New Therapies for Kidney Transplantation.
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Naesens M, Loupy A, Hilbrands L, Oberbauer R, Bellini MI, Glotz D, Grinyó J, Heemann U, Jochmans I, Pengel L, Reinders M, Schneeberger S, and Budde K
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- Biomarkers, Humans, Marketing, Drug Approval, Kidney Transplantation
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Conditional marketing authorization (CMA) facilitates timely access to new drugs for illnesses with unmet clinical needs, such as late graft failure after kidney transplantation. Late graft failure remains a serious, burdensome, and life-threatening condition for recipients. This article has been developed from content prepared by members of a working group within the European Society for Organ Transplantation (ESOT) for a Broad Scientific Advice request, submitted by ESOT to the European Medicines Agency (EMA), and reviewed by the EMA in 2020. The article presents the rationale for using surrogate endpoints in clinical trials aiming at improving late graft failure rates, to enable novel kidney transplantation therapies to be considered for CMA and improve access to medicines. The paper also provides background data to illustrate the relationship between primary and surrogate endpoints. Developing surrogate endpoints and a CMA strategy could be particularly beneficial for studies where the use of primary endpoints would yield insufficient statistical power or insufficient indication of long-term benefit following transplantation., Competing Interests: LH reports speaker fees from Astellas, consultancy and research support from Chiesi, consultancy for Novartis, and research support from Sandoz. RO has received grants/research support from Amgen, Astellas, and Chiesi; and speakers' bureaux/honoraria from Amgen, Astellas, Chiesi, Hansa, Neovii, Novartis, and Teva. SS has received grants/research support from Bridge to Life, Chiesi, Neovii, Novartis, Organ Recovery Systems, and Sandoz; speakers' bureaux/honoraria from Astellas, BMS, Chiesi, Novartis, OrganOx, and Sanofi; and consulting fees from Astellas, Atara, Merck, NefroHealth, Novartis, Sandoz, and Teva. DG reports consultancy agreements and scientific boards for AstraZeneca, BMS, Hansa, and Sanofi. UH has received grants/research support from Baxter, Chiesi, and Neovii; speakers' bureaux/honoraria from Chiesi and Hansa; and consulting fees from Astellas, Hansa, Neovii, Novartis, and Teva. IJ's institution has received speaker's fees from XVIVO Perfusion. MR has received lecture fees from Astellas and Chiesi; and research grant support (paid to institution) from Astellas and Chiesi for investigator-initiated studies. SS has received grants/research support from Bridge to Life, Chiesi, Neovii, Novartis, Organ Recovery Systems, and Sandoz; speakers' bureaux/honoraria from Astellas, BMS, Chiesi, Novartis, OrganOx, and Sanofi; and consulting fees from Astellas, Atara, Merck, NefroHealth, Novartis, Sandoz, and Teva. KB has received honoraria and/or research funding from Alexion, Astellas, Bristol Myers Squibb, Chiesi, Fresenius, Hansa, Hexal, Merck, Novartis, Otsuka, Pfizer, Roche, Sandoz, Siemens, and Veloxis. The remaining authors declare that the work was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2022 Naesens, Loupy, Hilbrands, Oberbauer, Bellini, Glotz, Grinyó, Heemann, Jochmans, Pengel, Reinders, Schneeberger and Budde.)
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- 2022
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32. Patient-Reported Outcomes as Endpoints in Clinical Trials of Kidney Transplantation Interventions.
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Tong A, Oberbauer R, Bellini MI, Budde K, Caskey FJ, Dobbels F, Pengel L, Rostaing L, Schneeberger S, and Naesens M
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- Humans, Patient Reported Outcome Measures, Quality of Life, Surveys and Questionnaires, Transplant Recipients, Kidney Transplantation, Nephrology methods
- Abstract
Patient-reported outcomes (PROs) that assess individuals' perceptions of life participation, medication adherence, disease symptoms, and therapy side effects are extremely relevant in the context of kidney transplantation. All PROs are potentially suitable as primary or secondary endpoints in interventional trials that aim to improve outcomes for transplant recipients. Using PRO measures (PROMs) in clinical trials facilitates assessment of the patient's perspective of their health, but few measures have been developed and evaluated in kidney transplant recipients; robust methodologies, which use validated instruments and established frameworks for reporting, are essential. Establishing a core PROM for life participation in kidney transplant recipients is a critically important need, which is being developed and validated by the Standardized Outcomes in Nephrology (SONG)-Tx Initiative. Measures involving electronic medication packaging and smart technologies are gaining traction for monitoring adherence, and could provide more robust information than questionnaires, interviews, and scales. This article summarizes information on PROs and PROMs that was included in a Broad Scientific Advice request on clinical trial design and endpoints in kidney transplantation. This request was submitted to the European Medicines Agency (EMA) by the European Society for Organ Transplantation in 2016. Following modifications, the EMA provided its recommendations in late 2020., Competing Interests: RO has received grants/research support from Amgen, Astellas, and Chiesi; and speakers’ bureaux/honoraria from Amgen, Astellas, Chiesi, Hansa, Neovii, Novartis, and Teva. KB has received honoraria and/or research funding from Alexion, Astellas, Bristol Myers Squibb, Chiesi, Fresenius, Hansa, Hexal, Merck, Novartis, Otsuka, Pfizer, Roche, Sandoz, Siemens, and Veloxis. SS has received grants/research support from Bridge to Life, Chiesi, Neovii, Novartis, Organ Recovery Systems, and Sandoz; speakers’ bureaux/honoraria from Astellas, BMS, Chiesi, Novartis, OrganOx, and Sanofi; and consulting fees from Astellas, Atara, Merck, NefroHealth, Novartis, Sandoz, and Teva. The remaining authors declare that the work was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2022 Tong, Oberbauer, Bellini, Budde, Caskey, Dobbels, Pengel, Rostaing, Schneeberger and Naesens.)
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- 2022
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33. Alloimmune Risk Stratification for Kidney Transplant Rejection.
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Bestard O, Thaunat O, Bellini MI, Böhmig GA, Budde K, Claas F, Couzi L, Furian L, Heemann U, Mamode N, Oberbauer R, Pengel L, Schneeberger S, and Naesens M
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- Graft Rejection, Graft Survival, HLA Antigens, Histocompatibility Testing, Humans, Living Donors, Risk Assessment, Tissue Donors, Kidney Transplantation
- Abstract
Different types of kidney transplantations are performed worldwide, including biologically diverse donor/recipient combinations, which entail distinct patient/graft outcomes. Thus, proper immunological and non-immunological risk stratification should be considered, especially for patients included in interventional randomized clinical trials. This paper was prepared by a working group within the European Society for Organ Transplantation, which submitted a Broad Scientific Advice request to the European Medicines Agency (EMA) relating to clinical trial endpoints in kidney transplantation. After collaborative interactions, the EMA sent its final response in December 2020, highlighting the following: 1) transplantations performed between human leukocyte antigen (HLA)-identical donors and recipients carry significantly lower immunological risk than those from HLA-mismatched donors; 2) for the same allogeneic molecular HLA mismatch load, kidney grafts from living donors carry significantly lower immunological risk because they are better preserved and therefore less immunogenic than grafts from deceased donors; 3) single-antigen bead testing is the gold standard to establish the repertoire of serological sensitization and is used to define the presence of a recipient's circulating donor-specific antibodies (HLA-DSA); 4) molecular HLA mismatch analysis should help to further improve organ allocation compatibility and stratify immunological risk for primary alloimmune activation, but without consensus regarding which algorithm and cut-off to use it is difficult to integrate information into clinical practice/study design; 5) further clinical validation of other immune assays, such as those measuring anti-donor cellular memory (T/B cell ELISpot assays) and non-HLA-DSA, is needed; 6) routine clinical tests that reliably measure innate immune alloreactivity are lacking., Competing Interests: OB has received research funding from Chiesi and served as adviser for Hansa Biopharma. OT has received research funding from bioMérieux, Bristol Myers Squibb, and Immucor; and has consultancy agreements with Biotest and Novartis. GB has received honoraria and/or research funding from Astellas, CareDx, CSL Behring, Fresenius, Hansa, Neovii, and Vitaeris. KB has received honoraria and/or research funding from Alexion, Astellas, Bristol Myers Squibb, Chiesi, Fresenius, Hansa, Hexal, Merck, Novartis, Otsuka, Pfizer, Roche, Sandoz, Siemens, and Veloxis. FC is a scientific adviser for GenDx and Immucor. LF has received honoraria and/or research funding from Astellas, Chiesi, Hansa, and Novartis. UH has received grants/research support from Baxter, Chiesi, and Neovii; speakers’ bureaux/honoraria from Chiesi and Hansa; and consulting fees from Astellas, Hansa, Neovii, Novartis, and Teva. NM has received honoraria from Hansa, Chiesi, Novartis, and Takeda. RO has received grants/research support from Amgen, Astellas, and Chiesi; and speakers’ bureaux/honoraria from Amgen, Astellas, Chiesi, Hansa, Neovii, Novartis, and Teva. SS has received grants/research support from Bridge to Life, Chiesi, Neovii, Novartis, Organ Recovery Systems, and Sandoz; speakers’ bureaux/honoraria from Astellas, BMS, Chiesi, Novartis, OrganOx, and Sanofi; and consulting fees from Astellas, Atara, Merck, NefroHealth, Novartis, Sandoz, and Teva. The remaining authors declare that the work was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2022 Bestard, Thaunat, Bellini, Böhmig, Budde, Claas, Couzi, Furian, Heemann, Mamode, Oberbauer, Pengel, Schneeberger and Naesens.)
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- 2022
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34. Surrogate Endpoints for Late Kidney Transplantation Failure.
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Naesens M, Budde K, Hilbrands L, Oberbauer R, Bellini MI, Glotz D, Grinyó J, Heemann U, Jochmans I, Pengel L, Reinders M, Schneeberger S, and Loupy A
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- Biomarkers, Glomerular Filtration Rate, Graft Rejection etiology, Graft Rejection prevention & control, Graft Survival, HLA Antigens, Humans, Kidney, Transplant Recipients, Kidney Transplantation, Renal Insufficiency surgery
- Abstract
In kidney transplant recipients, late graft failure is often multifactorial. In addition, primary endpoints in kidney transplantation studies seek to demonstrate the short-term efficacy and safety of clinical interventions. Although such endpoints might demonstrate short-term improvement in specific aspects of graft function or incidence of rejection, such findings do not automatically translate into meaningful long-term graft survival benefits. Combining many factors into a well-validated model is therefore more likely to predict long-term outcome and better reflect the complexity of late graft failure than using single endpoints. If conditional marketing authorization could be considered for therapies that aim to improve long-term outcomes following kidney transplantation, then the surrogate endpoint for graft failure in clinical trial settings needs clearer definition. This Consensus Report considers the potential benefits and drawbacks of several candidate surrogate endpoints (including estimated glomerular filtration rate, proteinuria, histological lesions, and donor-specific anti-human leukocyte antigen antibodies) and composite scoring systems. The content was created from information prepared by a working group within the European Society for Organ Transplantation (ESOT). The group submitted a Broad Scientific Advice request to the European Medicines Agency (EMA), June 2020: the request focused on clinical trial design and endpoints in kidney transplantation. Following discussion and refinement, the EMA made final recommendations to ESOT in December 2020 regarding the potential to use surrogate endpoints in clinical studies that aim to improving late graft failure., Competing Interests: KB has received honoraria and/or research funding from Alexion, Astellas, Bristol Myers Squibb, Chiesi, Fresenius, Hansa, Hexal, Merck, Novartis, Otsuka, Pfizer, Roche, Sandoz, Siemens, and Veloxis. LH reports speaker fees from Astellas, consultancy and research support from Chiesi, consultancy for Novartis, and research support from Sandoz. RO has received grants/research support from Amgen, Astellas, and Chiesi; and speakers’ bureaux/honoraria from Amgen, Astellas, Chiesi, Hansa, Neovii, Novartis, and Teva. DG reports consultancy agreements and scientific boards for AstraZeneca, BMS, Hansa, and Sanofi. UH has received grants/research support from Baxter, Chiesi, and Neovii; speakers’ bureaux/honoraria from Chiesi and Hansa; and consulting fees from Astellas, Hansa, Neovii, Novartis, and Teva. IJ’s institution has received speaker’s fees from XVIVO Perfusion. MR has received lecture fees from Astellas and Chiesi; and research grant support (paid to institution) from Astellas and Chiesi for investigator-initiated studies. SS has received grants/research support from Bridge to Life, Chiesi, Neovii, Novartis, Organ Recovery Systems, and Sandoz; speakers’ bureaux/honoraria from Astellas, BMS, Chiesi, Novartis, OrganOx, and Sanofi; and consulting fees from Astellas, Atara, Merck, NefroHealth, Novartis, Sandoz, and Teva. The remaining authors declare that the work was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2022 Naesens, Budde, Hilbrands, Oberbauer, Bellini, Glotz, Grinyó, Heemann, Jochmans, Pengel, Reinders, Schneeberger and Loupy.)
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- 2022
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35. Proposed Definitions of Antibody-Mediated Rejection for Use as a Clinical Trial Endpoint in Kidney Transplantation.
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Roufosse C, Becker JU, Rabant M, Seron D, Bellini MI, Böhmig GA, Budde K, Diekmann F, Glotz D, Hilbrands L, Loupy A, Oberbauer R, Pengel L, Schneeberger S, and Naesens M
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- Antibodies, Biopsy, Graft Rejection, HLA Antigens, Humans, Isoantibodies, Kidney Transplantation
- Abstract
Antibody-mediated rejection (AMR) is caused by antibodies that recognize donor human leukocyte antigen (HLA) or other targets. As knowledge of AMR pathophysiology has increased, a combination of factors is necessary to confirm the diagnosis and phenotype. However, frequent modifications to the AMR definition have made it difficult to compare data and evaluate associations between AMR and graft outcome. The present paper was developed following a Broad Scientific Advice request from the European Society for Organ Transplantation (ESOT) to the European Medicines Agency (EMA), which explored whether updating guidelines on clinical trial endpoints would encourage innovations in kidney transplantation research. ESOT considers that an AMR diagnosis must be based on a combination of histopathological factors and presence of donor-specific HLA antibodies in the recipient. Evidence for associations between individual features of AMR and impaired graft outcome is noted for microvascular inflammation scores ≥2 and glomerular basement membrane splitting of >10% of the entire tuft in the most severely affected glomerulus. Together, these should form the basis for AMR-related endpoints in clinical trials of kidney transplantation, although modifications and restrictions to the Banff diagnostic definition of AMR are proposed for this purpose. The EMA provided recommendations based on this Broad Scientific Advice request in December 2020; further discussion, and consensus on the restricted definition of the AMR endpoint, is required., Competing Interests: CR is supported by the National Institute for Health Research (NIHR) Biomedical Research Centre based at Imperial College Healthcare NHS Trust and Imperial College London. The views expressed are those of the authors and not necessarily those of the NHS, the NIHR or the Department of Health. CR’s research activity is made possible with generous support from Sidharth and Indira Burman. JUB consults for Sanofi. MR has received lecture fees from Astellas and Chiesi; and research grant support (paid to institution) from Astellas and Chiesi for investigator-initiated studies. GB has received honoraria and/or research funding from Astellas, CareDx, CSL Behring, Fresenius, Hansa, Neovii, and Vitaeris. KB has received honoraria and/or research funding from Alexion, Astellas, Bristol Myers Squibb, Chiesi, Fresenius, Hansa, Hexal, Merck, Novartis, Otsuka, Pfizer, Roche, Sandoz, Siemens, and Veloxis. DG reports consultancy agreements and scientific boards for AstraZeneca, BMS, Hansa, and Sanofi. LH reports speaker fees from Astellas, consultancy and research support from Chiesi, consultancy for Novartis, and research support from Sandoz. RO has received grants/research support from Amgen, Astellas, and Chiesi; and speakers’ bureaux/honoraria from Amgen, Astellas, Chiesi, Hansa, Neovii, Novartis, and Teva. SS has received grants/research support from Bridge to Life, Chiesi, Neovii, Novartis, Organ Recovery Systems, and Sandoz; speakers’ bureaux/honoraria from Astellas, BMS, Chiesi, Novartis, OrganOx, and Sanofi; and consulting fees from Astellas, Atara, Merck, NefroHealth, Novartis, Sandoz, and Teva. The remaining authors declare that the work was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2022 Roufosse, Becker, Rabant, Seron, Bellini, Böhmig, Budde, Diekmann, Glotz, Hilbrands, Loupy, Oberbauer, Pengel, Schneeberger and Naesens.)
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- 2022
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36. How good is a living donor? Systematic review and meta-analysis of the effect of donor demographics on post kidney transplant outcomes.
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Bellini MI, Nozdrin M, Pengel L, Knight S, and Papalois V
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- Creatinine, Delayed Graft Function epidemiology, Delayed Graft Function etiology, Female, Graft Rejection epidemiology, Graft Rejection prevention & control, Graft Survival, Humans, Incidence, Living Donors, Male, Obesity, Tissue Donors, Kidney Transplantation adverse effects
- Abstract
Background and Aims: Living donor kidneys are considered the best quality organs. In the attempt to expand the donor pool, the donor's age, sex and body mass index (BMI) might be considered as potential determinants of the kidney transplant outcomes, and thus guide recipient selection. We aimed to investigate the effects of donor demographics on kidney function, graft and recipient survival, delayed graft function (DGF) and acute rejection (AR)., Methods: Systematic review and meta-analysis. EMBASE, MEDLINE, Web of Science, BIOSIS, CABI, SciELO and Cochrane were searched using algorithms. NHBLI tools were used for risk of bias assessment. Mean difference (MD), standardized mean difference (SMD), and risk ratio (RR) were calculated in Revman 5.4 RESULTS: Altogether, 5129 studies were identified by the search algorithm; 47 studies met the inclusion criteria and were analyzed. No significant difference in recipient 1-year survival was found between recipients of donors aged < 50 vs donors aged > 50 (RR = 0.65 95% CI: 0.1-4.1), and recipients of donors aged < 60 vs donors aged > 60 (RR = 0.81 95% CI: 0.3-2.3). Graft survival was significantly higher in recipients of grafts from donors aged < 60. Risk of AR (RR = 0.62 95% CI: 0.5-0.8) and DGF (RR = 0.28 95% CI: 0.1-0.9) were significantly lower in recipients of grafts from donors aged < 60. One-year serum creatinine was significantly lower in recipients from donors aged < 60 years compared to donors aged > 60 years (MD = 0.3 mg/dl 95% CI: 0.1-0.9), although there was high heterogeneity. Recipients of grafts from male donors had lower 1-year serum creatinine (MD = 0.12 mg/dl 95% CI: 0.2-0.1) and higher eGFR compared to recipients of female donors (p < 0.00001). Donor obesity increased the incidence of delayed graft function but not acute rejection (RR = 0.66 95% CI: 0.32-1.34)., Conclusions: Older donor age was associated with worse post-transplant outcomes and recipients of male donors had better 1-year eGFR. Donor obesity affects the incidence of delayed graft function, but not the incidence of acute rejection in recipients., (© 2022. The Author(s).)
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- 2022
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37. The Impact of Recipient Demographics on Outcomes from Living Donor Kidneys: Systematic Review and Meta-Analysis.
- Author
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Bellini MI, Nozdrin M, Pengel L, Knight S, and Papalois V
- Abstract
Background and Aims: Recipient demographics affect outcomes after kidney transplantation. The aim of this study was to assess, for kidneys retrieved from living donors, the effect of recipient sex, ethnicity, and body mass index (BMI) on delayed graft function (DGF) and one-year graft function, incidence of acute rejection (AR), and recipient and graft survivals. Methods: A systematic review and meta-analysis was performed. EMBASE and MEDLINE databases were searched using algorithms through Ovid. Web of Science collection, BIOSIS, CABI, Korean Journal database, Russian Science Citation Index, and SciELO were searched through Web of Science. Cochrane database was also searched. Risk of bias was assessed using the NHBLI tools. Data analysis was performed using Revman 5.4. Mean difference (MD) and risk ratio (RR) were used in analysis. Results: A total of 5129 studies were identified; 24 studies met the inclusion criteria and were analysed. Female recipients were found to have a significantly lower serum creatinine 1-year-post renal transplantation (MD: -0.24 mg/dL 95%CI: -0.18 to -0.29 p < 0.01) compared to male recipients. No significant difference in survival between male and female recipients nor between Caucasians and Africans was observed ( p = 0.08). However, Caucasian recipients had a higher 1-year graft survival compared to African recipients (95% CI 0.52-0.98) with also a lower incidence of DGF (RR = 0.63 p < 0.01) and AR (RR = 0.55 p < 0.01). Recipient obesity (BMI > 30) was found to have no effect on 1-year recipient ( p = 0.28) and graft survival ( p = 0.93) compared to non-obese recipients although non-obese recipients had a lower rate of DGF (RR = 0.65 p < 0.01) and AR (RR = 0.81 p < 0.01) compared to obese recipients. Conclusions: Gender mismatch between male recipients and female donors has negative impact on graft survival. African ethnicity and obesity do not to influence recipient and graft survival but negatively affect DGF and AR rates.
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- 2021
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38. COVID-19 and education: restructuring after the pandemic.
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Bellini MI, Pengel L, Potena L, and Segantini L
- Subjects
- Biomedical Research standards, Biomedical Research trends, COVID-19 epidemiology, Global Health, Humans, Italy epidemiology, Pandemics, Peer Review, Research standards, Peer Review, Research trends, Periodicals as Topic standards, Periodicals as Topic trends, Physical Distancing, Biomedical Research organization & administration, COVID-19 prevention & control, Education, Distance organization & administration, Specialties, Surgical education, Telemedicine organization & administration
- Abstract
COVID-19 challenges to keep a valuable educational offer with lockdown measures and social distancing are reviewed. Scientific Societies had to think of new alternatives to maintain meetings with conversion to a virtual format and development of online resources, rapidly available and broadly accessible. Other in person activities as face-to-face clinics have been substituted by telemedicine; the same happened with surgical training in theatre, given the suspension of most of the operations. Finally, the need to share and communicate in a continuous evolving scenario, has impacted negatively the integrity of peer review process, not following the normal procedures to ensure scientific integrity and reproducibility in the earliest phases of the pandemic., (© 2021 Steunstichting ESOT. Published by John Wiley & Sons Ltd.)
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- 2021
- Full Text
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39. Supplemental oxygen during hypothermic kidney preservation: A systematic review.
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O'Callaghan JM, Pall KT, and Pengel LHM
- Subjects
- Humans, Kidney Transplantation, Organ Preservation, Oxygen therapeutic use
- Abstract
We reviewed the evidence for ex-vivo Supplemental Oxygen during Hypothermic preservation (SOH) for deceased donor kidneys. Bibliographic databases were searched for human and animal studies of SOH in kidney transplantation reporting on patient or animal survival rate, discard rate, technical complications or renal function outcomes. We make special reference to a specific subgroup: supplemental oxygen applied during cold perfusion, referred to as Hypothermic Oxygenated Perfusion (HOP). Four human and 25 animal studies were identified. The data present conflicting results but suggest that the effects of oxygen on restoring kidney function during preservation may be of value for DCD kidneys and/or kidneys that have undergone a period of hypotension, warm ischemia or poor perfusion in the donor. There is very little information available from human or animal studies. This work highlights to the transplant community that far more high quality clinical studies are required to understand this technology and its role before widespread clinical introduction., (Copyright © 2017 The Authors. Published by Elsevier Inc. All rights reserved.)
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- 2017
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40. Evidence-based medicine in daily surgical decision making: a survey-based comparison between the UK and Germany.
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Schnitzbauer AA, Proneth A, Pengel L, Ansorg J, Anthuber M, Bechstein WO, Schlitt HJ, and Geissler EK
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- Adult, Attitude of Health Personnel, Female, General Surgery statistics & numerical data, Germany, Humans, Male, Middle Aged, Surveys and Questionnaires, United Kingdom, Decision Making, Evidence-Based Medicine statistics & numerical data, General Surgery standards
- Abstract
Background: Evidence-based medicine (EbM) is a vital part of reasonable and conclusive decision making for clinicians in daily clinical work. To analyze the knowledge and the attitude of surgeons towards EbM, a survey was performed in the UK and Germany., Methods: A web-based questionnaire was distributed via mailing lists from the Royal College of Surgeons of England (RCSE) and the Berufsverband Deutscher Chirurgen (BDC). Our primary aim was to get information about knowledge of EbM amongst German and British surgeons., Results: A total of 549 individuals opened the questionnaire, but only 198 questionnaires were complete and valid for analysis. In total, 40,000 recipients were approached via the mailing lists of the BDC and RCSE. The response rate was equally low in both countries. On a scale from 1 (unimportant) to 10 (very important), all participants rated EbM as very important for daily clinical decision making (7.3 ± 1.9) as well as for patients (7.8 ± 1.9) and the national health system (7.8 ± 1.9). On a scale from 1 (unimportant) to 5 (very important), systematic reviews (4.6 ± 0.6) and randomized controlled trials (4.6 ± 0.6) were identified as the highest levels of study designs to enhance evidence in medicine. British surgeons considered EbM to be more important in daily clinical work when compared to data from German surgeons (7.9 ± 1.6 vs. 6.7 ± 2.1, p < 0.001). Subgroup analysis showed different results in some categories; however, a pattern to explain the differences was not evident. Personal requirements expressed in a free text field emphasized the results and reflected concerns such as broad unwillingness and lack of interdisciplinary approaches for patients (n = 59: 25 in the UK and 34 in Germany)., Conclusion: The overall results show that EbM is believed to be important by surgeons in the UK and Germany. However, perception of EbM in the respective health system (UK vs. Germany) may be different. Nonetheless, EbM is an important tool to navigate through daily clinical problems although a discrepancy between the knowledge of theoretical abstract terms and difficulties in implementing EbM in daily clinical work has been detected. The provision of infrastructure, courses and structured education as a permanent instrument will advance the knowledge, application and improvement of EbM in the future., (© 2014 S. Karger AG, Basel.)
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- 2015
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41. The transplant library of randomized controlled trials and systematic reviews.
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Pengel L and Morris P
- Subjects
- Databases, Bibliographic, Humans, Software, User-Computer Interface, Randomized Controlled Trials as Topic, Review Literature as Topic, Transplantation methods
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- 2011
- Full Text
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42. The effect of ankle taping on detection of inversion-eversion movements in participants with recurrent ankle sprain.
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Refshauge KM, Raymond J, Kilbreath SL, Pengel L, and Heijnen I
- Subjects
- Adult, Ankle Injuries physiopathology, Athletic Tape, Female, Humans, Male, Movement, Orthopedic Procedures, Range of Motion, Articular, Recurrence, Sprains and Strains physiopathology, Young Adult, Ankle Injuries therapy, Proprioception, Sprains and Strains therapy
- Abstract
Background: Taping is often used to counter the proprioceptive deficit after joint injury such as ankle sprain. However, the effect of taping on proprioceptive acuity at the ankle is unclear, with conflicting findings., Hypothesis: Application of tape improves detection of inversion and eversion movements at the ankle., Study Design: Controlled laboratory study., Methods: The 70% threshold for movement detection was measured in 16 participants with recurrent ankle sprain under 2 conditions: with the ankle taped or untaped. The threshold for movement detection was examined at 3 velocities (0.1 deg/s, 0.5 deg/s, and 2.5 deg/s) and in 2 directions (inversion and eversion)., Results: Application of tape significantly decreased the ability to detect movements at the ankle (P < .023). For example, at 0.5 deg/s, the 70% detection threshold was 3.40 degrees +/- 1.05 degrees in inversion and 3.49 degrees +/- 1.15 degrees in eversion at the untaped ankle, and 4.02 degrees +/- 0.86 degrees in inversion and 4.04 degrees +/- 0.89 degrees in eversion at the taped ankle., Conclusion: Taping the ankle decreased the ability to detect movement in the inversion-eversion plane in participants with recurrent ankle sprain., Clinical Relevance: The findings suggest that the efficacy of taping is unlikely to be explained by an enhanced ability to detect inversion or eversion movements. However, because it has been found effective in reducing the incidence of ankle sprain, clinicians should continue taping to reduce the likelihood of resprain.
- Published
- 2009
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43. Searching the transplantation library.
- Author
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Barcena L, Pengel L, and Morris PJ
- Subjects
- Databases, Bibliographic, Libraries, Organ Transplantation, Randomized Controlled Trials as Topic
- Published
- 2008
- Full Text
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44. Registry of randomized controlled trials in transplantation: July 1 to December 31, 2006.
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Pengel L, Barcena L, and Morris PJ
- Subjects
- Humans, Organ Transplantation, Randomized Controlled Trials as Topic, Registries
- Published
- 2007
- Full Text
- View/download PDF
45. Registry of randomized controlled trials in transplantation: January 1 to June 30, 2006.
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Pengel L, Barcena L, and Morris PJ
- Subjects
- Animals, Humans, Immunosuppressive Agents pharmacology, Time Factors, Organ Transplantation statistics & numerical data, Randomized Controlled Trials as Topic, Registries
- Published
- 2007
- Full Text
- View/download PDF
46. Postural and respiratory functions of the pelvic floor muscles.
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Hodges PW, Sapsford R, and Pengel LH
- Subjects
- Adult, Anal Canal, Arm, Electromyography, Female, Humans, Hypercapnia physiopathology, Male, Middle Aged, Motor Activity physiology, Movement physiology, Muscle Contraction physiology, Respiratory Dead Space physiology, Vagina, Muscle, Skeletal physiology, Pelvic Floor physiology, Posture physiology, Respiratory Mechanics physiology
- Abstract
Aims: Due to their contribution to modulation of intra-abdominal pressure (IAP) and stiffness of the sacroiliac joints, the pelvic floor muscles (PFM) have been argued to provide a contribution to control of the lumbar spine and pelvis. Furthermore, as IAP is modulated during respiration this is likely to be accompanied by changes in PFM activity., Methods: In order to evaluate the postural and respiratory function of the PFM, recordings of anal and vaginal electromyographic activity (EMG) were made with surface electrodes during single and repetitive arm movements that challenge the stability of the spine. EMG recordings were also made during respiratory tasks: quiet breathing and breathing with increased dead-space to induce hypercapnoea., Results: EMG activity of the PFM was increased in advance of deltoid muscle activity as a component of the pre-programmed anticipatory postural activity. This activity was independent of the direction of arm movement. During repetitive movements, PFM EMG was tonic with phasic bursts at the frequency of arm movement. This activity was related to the peak acceleration of the arm, and therefore the amplitude of the reactive forces imposed on the spine. Respiratory activity was observed for the anal and vaginal EMG and was primarily expiratory. When subjects moved the arm repetitively while breathing, PFM EMG was primarily modulated in association with arm movement with little respiratory modulation., Conclusions: This study provides evidence that the PFM contribute to both postural and respiratory functions.
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- 2007
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47. Registry of randomized controlled trials in transplantation: July 1-December 31, 2005 [corrected].
- Author
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Pengel L, Barcena L, and Morris PJ
- Subjects
- Heart Transplantation statistics & numerical data, Kidney Transplantation statistics & numerical data, Liver Transplantation statistics & numerical data, Pancreas Transplantation statistics & numerical data, Registries, Organ Transplantation statistics & numerical data, Randomized Controlled Trials as Topic statistics & numerical data
- Published
- 2006
- Full Text
- View/download PDF
48. Registry of randomized controlled trials in transplantation: January 1 to June 30, 2005.
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Pengel L, Barcena L, and Morris PJ
- Subjects
- Humans, Organ Transplantation, Randomized Controlled Trials as Topic, Registries
- Published
- 2006
- Full Text
- View/download PDF
49. Registry of randomized controlled trials in transplantation.
- Author
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Barcena L, Pengel L, and Morris PJ
- Subjects
- Humans, Immunosuppression Therapy methods, Immunosuppression Therapy statistics & numerical data, Transplantation Immunology, United Kingdom, Randomized Controlled Trials as Topic statistics & numerical data, Registries, Transplantation statistics & numerical data
- Published
- 2005
- Full Text
- View/download PDF
50. Registry of randomized controlled trials in transplantation.
- Author
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Pengel L, Barcena L, and Morris PJ
- Subjects
- Humans, Organ Transplantation, Randomized Controlled Trials as Topic statistics & numerical data, Registries
- Published
- 2005
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