Mr Tom Gallagher, Division of Liver and Pancreas Transplantation, St. Vincent's University Hospital Transplant Centre, Dublin
Methodological Appraisers:
Katriona O'Donoghue, Centre for Evidence in Transplantation,The Royal College of Surgeons of England
Anam Ayaz-Shah, Centre for Evidence in Transplantation, The Royal College of Surgeons of England.
Overall Guideline Assessment:
★★★★☆☆☆ (4 of 7)
Appraiser 1
Appraiser 2
Appraiser 3
5
3
4
Recommendation for future use
Appraiser 1
Appraiser 2
Appraiser 3
Yes with modifications
Yes with modifications
Yes
Domain 1 - Scope and Purpose
76%
Appraiser 1
Appraiser 2
Appraiser 3
1.
The overall objective(s) of the guideline is (are) specifically described
6
6
5
2.
The health question(s) covered by the guideline is (are) specifically described
4
5
6
3.
The population (patients, public, etc.) to whom the guideline is meant to apply is specifically described
5
6
7
Domain 2 - Stakeholder Involvement
54%
Appraiser 1
Appraiser 2
Appraiser 3
4.
The guideline development group includes individuals from all the relevant professional groups
5
3
4
5.
The views and preferences of the target population (patients, public, etc.) have been sought
3
4
2
6.
The target users of the guideline are clearly defined
6
6
5
Domain 3 - Rigour of Development
54%
Appraiser 1
Appraiser 2
Appraiser 3
7.
Systematic methods were used to search for evidence
4
3
6
8.
The criteria for selecting the evidence are clearly described
4
2
3
9.
The strengths and limitations of the body of evidence are clearly described
7
6
2
10.
The methods for formulating the recommendations are clearly described
5
2
3
11.
The health benefits, side effects, and risks have been considered in formulating the recommendations
6
2
4
12.
There is an explicit link between the recommendations and the supporting evidence
6
4
5
13.
The guideline has been externally reviewed by experts prior to its publication
5
6
6
14.
A procedure for updating the guideline is provided
4
1
6
Domain 4 - Clarity of Presentation
78%
Appraiser 1
Appraiser 2
Appraiser 3
15.
The recommendations are specific and unambiguous
6
6
6
16.
The different options for management of the condition or health issue are clearly presented
5
4
5
17.
Key recommendations are easily identifiable
7
6
6
Domain 5 - Applicability
26%
Appraiser 1
Appraiser 2
Appraiser 3
18.
The guideline describes facilitators and barriers to its application
3
3
5
19.
The guideline provides advice and/or tools on how the recommendations can be put into practice
2
1
2
20.
The potential resource implications of applying the recommendations have been considered
4
2
2
21.
The guideline presents monitoring and/ or auditing
3
1
3
Domain 6 - Editorial Independence
61%
Appraiser 1
Appraiser 2
Appraiser 3
22.
The views of the funding body have not influenced the content of the guideline
5
5
6
23.
Competing interests of guideline development group members have been recorded and addressed
5
4
3
Living donor liver transplantation (LDLT) has been increasingly embraced around the world as an important strategy to address the shortage of deceased donor livers. The aim of this guideline, approved by the International Liver Transplantation Society (ILTS), is to provide a collection of expert opinions, consensus, and best practices surrounding LDLT. Recommendations were developed from an analysis of the National Library of Medicine living donor transplantation indexed literature using the Grading of Recommendations Assessment, Development and Evaluation methodology. Writing was guided by the ILTS Policy on the Development and Use of Practice Guidelines (www.ilts.org). Intended for use by physicians, these recommendations support specific approaches to the diagnostic, therapeutic, and preventive aspects of care of living donor liver transplant recipients.
Dr Kevin Lu, Institute of Urology, Asia University Hospital, Taiwan
Methodological Appraisers:
Anam Ayaz-Shah, Centre for Evidence in Transplantation, The Royal College of Surgeons of England.
Katriona O'Donoghue, Centre for Evidence in Transplantation, The Royal College of Surgeons of England
Overall Guideline Assessment:
★★★★★☆☆ (5 of 7)
Appraiser 1
Appraiser 2
Appraiser 3
6
6
4
Recommendation for future use
Appraiser 1
Appraiser 2
Appraiser 3
Yes with modifications
Yes
Yes with modifications
Domain 1 - Scope and Purpose
81%
Appraiser 1
Appraiser 2
Appraiser 3
1.
The overall objective(s) of the guideline is (are) specifically described
7
7
6
2.
The health question(s) covered by the guideline is (are) specifically described
7
5
7
3.
The population (patients, public, etc.) to whom the guideline is meant to apply is specifically described
5
5
4
Domain 2 - Stakeholder Involvement
56%
Appraiser 1
Appraiser 2
Appraiser 3
4.
The guideline development group includes individuals from all the relevant professional groups
6
7
4
5.
The views and preferences of the target population (patients, public, etc.) have been sought
2
6
2
6.
The target users of the guideline are clearly defined
5
4
3
Domain 3 - Rigour of Development
54%
Appraiser 1
Appraiser 2
Appraiser 3
7.
Systematic methods were used to search for evidence
2
4
3
8.
The criteria for selecting the evidence are clearly described
3
1
4
9.
The strengths and limitations of the body of evidence are clearly described
7
7
4
10.
The methods for formulating the recommendations are clearly described
5
3
3
11.
The health benefits, side effects, and risks have been considered in formulating the recommendations
7
6
4
12.
There is an explicit link between the recommendations and the supporting evidence
5
7
5
13.
The guideline has been externally reviewed by experts prior to its publication
2
2
1
14.
A procedure for updating the guideline is provided
5
6
6
Domain 4 - Clarity of Presentation
74%
Appraiser 1
Appraiser 2
Appraiser 3
15.
The recommendations are specific and unambiguous
7
3
5
16.
The different options for management of the condition or health issue are clearly presented
6
6
5
17.
Key recommendations are easily identifiable
7
6
4
Domain 5 - Applicability
39%
Appraiser 1
Appraiser 2
Appraiser 3
18.
The guideline describes facilitators and barriers to its application
2
5
3
19.
The guideline provides advice and/or tools on how the recommendations can be put into practice
2
6
4
20.
The potential resource implications of applying the recommendations have been considered
3
5
1
21.
The guideline presents monitoring and/ or auditing
4
4
1
Domain 6 - Editorial Independence
72%
Appraiser 1
Appraiser 2
Appraiser 3
22.
The views of the funding body have not influenced the content of the guideline
4
7
4
23.
Competing interests of guideline development group members have been recorded and addressed
6
7
4
With current treatment regimens, a relatively high proportion of transplant recipients experience underimmunosuppression or overimmunosuppression. Recently, several promising biomarkers have been identified for determining patient alloreactivity, which help in assessing the risk of rejection and personal response to the drug; others correlate with graft dysfunction and clinical outcome, offering a realistic opportunity for personalized immunosuppression. This consensus document aims to help tailor immunosuppression to the needs of the individual patient. It examines current knowledge on biomarkers associated with patient risk stratification and immunosuppression requirements that have been generally accepted as promising. It is based on a comprehensive review of the literature and the expert opinion of the Biomarker Working Group of the International Association of Therapeutic Drug Monitoring and Clinical Toxicology. The quality of evidence was systematically weighted, and the strength of recommendations was rated according to the GRADE system. Three types of biomarkers are discussed: (1) those associated with the risk of rejection (alloreactivity/tolerance), (2) those reflecting individual response to immunosuppressants, and (3) those associated with graft dysfunction. Analytical aspects of biomarker measurement and novel pharmacokinetic-pharmacodynamic models accessible to the transplant community are also addressed. Conventional pharmacokinetic biomarkers may be used in combination with those discussed in this article to achieve better outcomes and improve long-term graft survival. Our group of experts has made recommendations for the most appropriate analysis of a proposed panel of preliminary biomarkers, most of which are currently under clinical evaluation in ongoing multicentre clinical trials. A section of Next Steps was also included, in which the Expert Committee is committed to sharing this knowledge with the Transplant Community in the form of triennial updates.
Mr John O’Callaghan, Centre for Evidence in Transplantation, The Royal College of Surgeons of England.
Methodological Appraisers:
Anam Ayaz-Shah, Centre for Evidence in Transplantation, The Royal College of Surgeons of England
Katriona O'Donoghue, Centre for Evidence in Transplantation, The Royal College of Surgeons of England
Overall Guideline Assessment:
★★★★☆☆☆ (4 of 7)
Appraiser 1
Appraiser 2
Appraiser 3
2
6
5
Recommendation for future use
Appraiser 1
Appraiser 2
Appraiser 3
Yes with modifications
Yes with modifications
Yes with modifications
Domain 1 - Scope and Purpose
94%
Appraiser 1
Appraiser 2
Appraiser 3
1.
The overall objective(s) of the guideline is (are) specifically described
6
7
6
2.
The health question(s) covered by the guideline is (are) specifically described
7
7
7
3.
The population (patients, public, etc.) to whom the guideline is meant to apply is specifically described
6
7
7
Domain 2 - Stakeholder Involvement
28%
Appraiser 1
Appraiser 2
Appraiser 3
4.
The guideline development group includes individuals from all the relevant professional groups
4
4
3
5.
The views and preferences of the target population (patients, public, etc.) have been sought
1
1
1
6.
The target users of the guideline are clearly defined
4
4
2
Domain 3 - Rigour of Development
32%
Appraiser 1
Appraiser 2
Appraiser 3
7.
Systematic methods were used to search for evidence
2
1
2
8.
The criteria for selecting the evidence are clearly described
1
3
3
9.
The strengths and limitations of the body of evidence are clearly described
1
3
4
10.
The methods for formulating the recommendations are clearly described
2
3
3
11.
The health benefits, side effects, and risks have been considered in formulating the recommendations
5
5
6
12.
There is an explicit link between the recommendations and the supporting evidence
6
7
6
13.
The guideline has been externally reviewed by experts prior to its publication
1
1
2
14.
A procedure for updating the guideline is provided
1
1
1
Domain 4 - Clarity of Presentation
78%
Appraiser 1
Appraiser 2
Appraiser 3
15.
The recommendations are specific and unambiguous
5
6
5
16.
The different options for management of the condition or health issue are clearly presented
5
6
6
17.
Key recommendations are easily identifiable
5
6
7
Domain 5 - Applicability
25%
Appraiser 1
Appraiser 2
Appraiser 3
18.
The guideline describes facilitators and barriers to its application
1
5
3
19.
The guideline provides advice and/or tools on how the recommendations can be put into practice
1
6
2
20.
The potential resource implications of applying the recommendations have been considered
1
5
1
21.
The guideline presents monitoring and/ or auditing
3
1
1
Domain 6 - Editorial Independence
33%
Appraiser 1
Appraiser 2
Appraiser 3
22.
The views of the funding body have not influenced the content of the guideline
1
1
1
23.
Competing interests of guideline development group members have been recorded and addressed
6
5
4
Atypical hemolytic uremic syndrome (aHUS) emerged during the last decade as a disease largely of complement dysregulation. This advance facilitated the development of novel, rational treatment options targeting terminal complement activation, e.g., using an anti-C5 antibody (eculizumab). We review treatment and patient management issues related to this therapeutic approach. We present consensus clinical practice recommendations generated by HUS International, an international expert group of clinicians and basic scientists with a focused interest in HUS. We aim to address the following questions of high relevance to daily clinical practice: Which complement investigations should be done and when? What is the importance of anti-factor H antibody detection? Who should be treated with eculizumab? Is plasma exchange therapy still needed? When should eculizumab therapy be initiated? How and when should complement blockade be monitored? Can the approved treatment schedule be modified? What approach should be taken to kidney and/or combined liver-kidney transplantation? How should we limit the risk of meningococcal infection under complement blockade therapy? A pressing question today regards the treatment duration. We discuss the need for prospective studies to establish evidence-based criteria for the continuation or cessation of anticomplement therapy in patients with and without identified complement mutations.
Mr John O’Callaghan, Centre for Evidence in Transplantation, The Royal College of Surgeons of England. Katriona O'Donoghue, Centre for Evidence in Transplantation, The Royal College of Surgeons of England.
Methodological Appraisers:
Dr Liset Pengel, Centre for Evidence in Transplantation, The Royal College of Surgeons of England
Katriona O'Donoghue, Centre for Evidence in Transplantation, The Royal College of Surgeons of England
Overall Guideline Assessment:
★★★★☆☆☆ (4 of 7)
Appraiser 1
Appraiser 2
Appraiser 3
4
3
4
Recommendation for future use
Appraiser 1
Appraiser 2
Appraiser 3
Yes with modifications
Yes with modifications
No
Domain 1 - Scope and Purpose
80%
Appraiser 1
Appraiser 2
Appraiser 3
1.
The overall objective(s) of the guideline is (are) specifically described
7
7
6
2.
The health question(s) covered by the guideline is (are) specifically described
6
4
4
3.
The population (patients, public, etc.) to whom the guideline is meant to apply is specifically described
5
7
6
Domain 2 - Stakeholder Involvement
56%
Appraiser 1
Appraiser 2
Appraiser 3
4.
The guideline development group includes individuals from all the relevant professional groups
4
3
7
5.
The views and preferences of the target population (patients, public, etc.) have been sought
2
1
2
6.
The target users of the guideline are clearly defined
6
7
7
Domain 3 - Rigour of Development
18%
Appraiser 1
Appraiser 2
Appraiser 3
7.
Systematic methods were used to search for evidence
1
1
2
8.
The criteria for selecting the evidence are clearly described
1
1
3
9.
The strengths and limitations of the body of evidence are clearly described
1
2
2
10.
The methods for formulating the recommendations are clearly described
3
1
3
11.
The health benefits, side effects, and risks have been considered in formulating the recommendations
4
3
3
12.
There is an explicit link between the recommendations and the supporting evidence
5
3
4
13.
The guideline has been externally reviewed by experts prior to its publication
1
1
2
14.
A procedure for updating the guideline is provided
1
1
1
Domain 4 - Clarity of Presentation
57%
Appraiser 1
Appraiser 2
Appraiser 3
15.
The recommendations are specific and unambiguous
6
4
2
16.
The different options for management of the condition or health issue are clearly presented
4
3
4
17.
Key recommendations are easily identifiable
6
6
5
Domain 5 - Applicability
32%
Appraiser 1
Appraiser 2
Appraiser 3
18.
The guideline describes facilitators and barriers to its application
2
4
6
19.
The guideline provides advice and/or tools on how the recommendations can be put into practice
1
4
5
20.
The potential resource implications of applying the recommendations have been considered
4
1
3
21.
The guideline presents monitoring and/ or auditing
3
1
1
Domain 6 - Editorial Independence
56%
Appraiser 1
Appraiser 2
Appraiser 3
22.
The views of the funding body have not influenced the content of the guideline
6
7
4
23.
Competing interests of guideline development group members have been recorded and addressed
6
1
2
The education, evaluation, and support of living donors before, during, and after donation have historically been considered the roles and responsibilities of transplant programs. Although intended to protect donors, ensure true informed consent, and prevent coercion, this structure often leaves referring nephrologists unclear about the donor process and uncertain regarding the ultimate outcome of potential donors for their patients. The aim of this article is to help the referring nephrologist understand the donor referral and evaluation process, help the referring nephrologist understand the responsibilities of the transplant program, and offer suggestions about how the referring nephrologist can help to improve efficiencies in the process of donor education and evaluation. A partnership between referring nephrologists and transplant programs is an important step in advancing living kidney donation. The referring nephrologists are the frontline providers and are in a unique position to offer education about living donation and improve efficiencies in the process. Understanding the donor referral and evaluation process, the responsibilities of the transplant program, and the potential role referring nephrologists can play in the process is critical to establishing such a partnership.
Mr John O’Callaghan, Centre for Evidence in Transplantation, The Royal College of Surgeons of England. Katriona O'Donoghue, Centre for Evidence in Transplantation, The Royal College of Surgeons of England.
Methodological Appraisers:
Dr Liset Pengel, Centre for Evidence in Transplantation, The Royal College of Surgeons of England
Katriona O'Donoghue, Centre for Evidence in Transplantation, The Royal College of Surgeons of England
Overall Guideline Assessment:
★★★★☆☆☆ (4 of 7)
Appraiser 1
Appraiser 2
Appraiser 3
4
4
5
Recommendation for future use
Appraiser 1
Appraiser 2
Appraiser 3
Yes with modifications
Yes with modifications
Yes
Domain 1 - Scope and Purpose
70%
Appraiser 1
Appraiser 2
Appraiser 3
1.
The overall objective(s) of the guideline is (are) specifically described
6
5
6
2.
The health question(s) covered by the guideline is (are) specifically described
6
1
5
3.
The population (patients, public, etc.) to whom the guideline is meant to apply is specifically described
5
6
7
Domain 2 - Stakeholder Involvement
50%
Appraiser 1
Appraiser 2
Appraiser 3
4.
The guideline development group includes individuals from all the relevant professional groups
5
6
7
5.
The views and preferences of the target population (patients, public, etc.) have been sought
2
1
2
6.
The target users of the guideline are clearly defined
4
2
7
Domain 3 - Rigour of Development
39%
Appraiser 1
Appraiser 2
Appraiser 3
7.
Systematic methods were used to search for evidence
4
3
6
8.
The criteria for selecting the evidence are clearly described
3
3
5
9.
The strengths and limitations of the body of evidence are clearly described
2
2
4
10.
The methods for formulating the recommendations are clearly described
4
5
5
11.
The health benefits, side effects, and risks have been considered in formulating the recommendations
5
1
4
12.
There is an explicit link between the recommendations and the supporting evidence
6
3
6
13.
The guideline has been externally reviewed by experts prior to its publication
1
1
4
14.
A procedure for updating the guideline is provided
1
1
1
Domain 4 - Clarity of Presentation
63%
Appraiser 1
Appraiser 2
Appraiser 3
15.
The recommendations are specific and unambiguous
5
5
5
16.
The different options for management of the condition or health issue are clearly presented
4
3
3
17.
Key recommendations are easily identifiable
5
7
6
Domain 5 - Applicability
39%
Appraiser 1
Appraiser 2
Appraiser 3
18.
The guideline describes facilitators and barriers to its application
2
5
7
19.
The guideline provides advice and/or tools on how the recommendations can be put into practice
2
4
6
20.
The potential resource implications of applying the recommendations have been considered
3
1
5
21.
The guideline presents monitoring and/ or auditing
3
1
1
Domain 6 - Editorial Independence
81%
Appraiser 1
Appraiser 2
Appraiser 3
22.
The views of the funding body have not influenced the content of the guideline
5
7
7
23.
Competing interests of guideline development group members have been recorded and addressed
6
3
7
Living donor kidney transplantation (LDKT) offers better quality of life and clinical outcomes, including patient survival, compared with remaining on dialysis or receiving a deceased donor kidney transplant. Although LDKT education within transplant centers for both potential recipients and living donors is very important, outreach and education to kidney patients in settings other than transplant centers and to the general public is also critical to increase access to this highly beneficial treatment. In June 2014, the American Society of Transplantation's Live Donor Community of Practice, with the support of 10 additional sponsors, convened a consensus conference to determine best practices in LDKT, including a workgroup focused on developing a set of recommendations for optimizing outreach and LDKT education outside of transplant centers. Members of this workgroup performed a structured literature review, conducted teleconference meetings, and met in person at the 2-day conference. Their efforts resulted in consensus around the following recommendations. First, preemptive transplantation should be promoted through increased LDKT education by primary care physicians and community nephrologists. Second, dialysis providers should be trained to educate their own patients about LDKT and deceased donor kidney transplantation. Third, partnerships between community organizations, organ procurement organizations, religious organizations, and transplant centers should be fostered to support transplantation. Fourth, use of technology should be improved or expanded to better educate kidney patients and their support networks. Fifth, LDKT education and outreach should be improved for kidney patients in rural areas. Finally, a consensus-driven, evidence-based public message about LDKT should be developed. Discussion of the effect and potential for implementation around each recommendation is featured, particularly regarding reducing racial and socioeconomic disparities in access to LDKT. To accomplish these recommendations, the entire community of professionals and organizations serving kidney patients must work collaboratively toward ensuring accurate, comprehensive, and up-to-date LDKT education for all patients, thereby reducing barriers to LDKT access and increasing LDKT rates.
Mr John O’Callaghan, Centre for Evidence in Transplantation, The Royal College of Surgeons of England. Katriona O'Donoghue, Centre for Evidence in Transplantation, The Royal College of Surgeons of England.
Methodological Appraisers:
Dr Liset Pengel, Centre for Evidence in Transplantation, The Royal College of Surgeons of England
Katriona O'Donoghue, Centre for Evidence in Transplantation, The Royal College of Surgeons of England
Overall Guideline Assessment:
★★★★☆☆☆ (4 of 7)
Appraiser 1
Appraiser 2
Appraiser 3
5
3
5
Recommendation for future use
Appraiser 1
Appraiser 2
Appraiser 3
Yes with modifications
Yes with modifications
Yes with modifications
Domain 1 - Scope and Purpose
83%
Appraiser 1
Appraiser 2
Appraiser 3
1.
The overall objective(s) of the guideline is (are) specifically described
6
6
6
2.
The health question(s) covered by the guideline is (are) specifically described
6
6
5
3.
The population (patients, public, etc.) to whom the guideline is meant to apply is specifically described
5
7
7
Domain 2 - Stakeholder Involvement
61%
Appraiser 1
Appraiser 2
Appraiser 3
4.
The guideline development group includes individuals from all the relevant professional groups
5
4
7
5.
The views and preferences of the target population (patients, public, etc.) have been sought
6
3
7
6.
The target users of the guideline are clearly defined
4
1
5
Domain 3 - Rigour of Development
24%
Appraiser 1
Appraiser 2
Appraiser 3
7.
Systematic methods were used to search for evidence
3
1
4
8.
The criteria for selecting the evidence are clearly described
2
1
1
9.
The strengths and limitations of the body of evidence are clearly described
2
3
1
10.
The methods for formulating the recommendations are clearly described
4
2
4
11.
The health benefits, side effects, and risks have been considered in formulating the recommendations
6
3
4
12.
There is an explicit link between the recommendations and the supporting evidence
6
1
3
13.
The guideline has been externally reviewed by experts prior to its publication
1
1
3
14.
A procedure for updating the guideline is provided
1
1
1
Domain 4 - Clarity of Presentation
59%
Appraiser 1
Appraiser 2
Appraiser 3
15.
The recommendations are specific and unambiguous
6
2
4
16.
The different options for management of the condition or health issue are clearly presented
6
1
4
17.
Key recommendations are easily identifiable
7
7
4
Domain 5 - Applicability
32%
Appraiser 1
Appraiser 2
Appraiser 3
18.
The guideline describes facilitators and barriers to its application
3
2
6
19.
The guideline provides advice and/or tools on how the recommendations can be put into practice
1
4
2
20.
The potential resource implications of applying the recommendations have been considered
5
3
2
21.
The guideline presents monitoring and/ or auditing
3
3
1
Domain 6 - Editorial Independence
56%
Appraiser 1
Appraiser 2
Appraiser 3
22.
The views of the funding body have not influenced the content of the guideline
6
6
7
23.
Competing interests of guideline development group members have been recorded and addressed
1
1
5
Live-donor kidney transplantation (LDKT) is the best treatment for eligible people with late-stage kidney disease. Despite this, living kidney donation rates have declined in the United States in recent years. A potential source of this decline is the financial impact on potential and actual living kidney donors (LKDs). Recent evidence indicates that the economic climate may be associated with the decline in LDKT and that there are nontrivial financial ramifications for some LKDs. In June 2014, the American Society of Transplantation's Live Donor Community of Practice convened a Consensus Conference on Best Practices in Live Kidney Donation. The conference included transplant professionals, patients, and other key stakeholders (with the financial support of 10 other organizations) and sought to identify best practices, knowledge gaps, and opportunities pertaining to living kidney donation. This workgroup was tasked with exploring systemic and financial barriers to living kidney donation. The workgroup reviewed literature that assessed the financial effect of living kidney donation, analyzed employment and insurance factors, discussed international models for addressing direct and indirect costs faced by LKDs, and summarized current available resources. The workgroup developed the following series of recommendations to reduce financial and systemic barriers and achieve financial neutrality for LKDs: (1) allocate resources for standardized reimbursement of LKDs' lost wages and incidental costs; (2) pass legislation to offer employment and insurability protections to LKDs; (3) create an LKD financial toolkit to provide standardized, vetted education to donors and providers about options to maximize donor coverage and minimize financial effect within the current climate; and (4) promote further research to identify systemic barriers to living donation and LDKT to ensure the creation of mitigation strategies.