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.
Dr Annemarie Weissenbacher, Nuffield Department of Surgical Sciences, University of Oxford, Oxford, UK.
Methodological Appraisers:
Rhiannon Deierhoi Reed, University of Alabama at Birmingham, Comprehensive Transplant Institute, USA
Katriona O'Donoghue, Centre for Evidence in Transplantation, The Royal College of Surgeons of England
Overall Guideline Assessment:
★★★★★★☆ (6 of 7)
Appraiser 1
Appraiser 2
Appraiser 3
4
7
6
Recommendation for future use
Appraiser 1
Appraiser 2
Appraiser 3
Yes with modifications
Yes
Yes
Domain 1 - Scope and Purpose
91%
Appraiser 1
Appraiser 2
Appraiser 3
1.
The overall objective(s) of the guideline is (are) specifically described
6
7
7
2.
The health question(s) covered by the guideline is (are) specifically described
6
7
7
3.
The population (patients, public, etc.) to whom the guideline is meant to apply is specifically described
4
7
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
4
7
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
6
4
7
Domain 3 - Rigour of Development
60%
Appraiser 1
Appraiser 2
Appraiser 3
7.
Systematic methods were used to search for evidence
4
5
4
8.
The criteria for selecting the evidence are clearly described
4
5
5
9.
The strengths and limitations of the body of evidence are clearly described
4
4
7
10.
The methods for formulating the recommendations are clearly described
6
4
6
11.
The health benefits, side effects, and risks have been considered in formulating the recommendations
5
6
7
12.
There is an explicit link between the recommendations and the supporting evidence
6
4
7
13.
The guideline has been externally reviewed by experts prior to its publication
5
1
7
14.
A procedure for updating the guideline is provided
1
1
2
Domain 4 - Clarity of Presentation
87%
Appraiser 1
Appraiser 2
Appraiser 3
15.
The recommendations are specific and unambiguous
6
6
7
16.
The different options for management of the condition or health issue are clearly presented
5
6
7
17.
Key recommendations are easily identifiable
6
7
6
Domain 5 - Applicability
56%
Appraiser 1
Appraiser 2
Appraiser 3
18.
The guideline describes facilitators and barriers to its application
2
4
1
19.
The guideline provides advice and/or tools on how the recommendations can be put into practice
4
7
6
20.
The potential resource implications of applying the recommendations have been considered
4
5
7
21.
The guideline presents monitoring and/ or auditing
4
4
4
Domain 6 - Editorial Independence
53%
Appraiser 1
Appraiser 2
Appraiser 3
22.
The views of the funding body have not influenced the content of the guideline
4
1
7
23.
Competing interests of guideline development group members have been recorded and addressed
5
1
7
This document was developed through the collaborative efforts of the Society of Critical Care Medicine, the American College of Chest Physicians, and the Association of Organ Procurement Organizations. Under the auspices of these societies, a multidisciplinary, multi-institutional task force was convened, incorporating expertise in critical care medicine, organ donor management, and transplantation. Members of the task force were divided into 13 subcommittees, each focused on one of the following general or organ-specific areas: death determination using neurologic criteria, donation after circulatory death determination, authorization process, general contraindications to donation, hemodynamic management, endocrine dysfunction and hormone replacement therapy, pediatric donor management, cardiac donation, lung donation, liver donation, kidney donation, small bowel donation, and pancreas donation. Subcommittees were charged with generating a series of management-related questions related to their topic. For each question, subcommittees provided a summary of relevant literature and specific recommendations. The specific recommendations were approved by all members of the task force and then assembled into a complete document. Because the available literature was overwhelmingly comprised of observational studies and case series, representing low-quality evidence, a decision was made that the document would assume the form of a consensus statement rather than a formally graded guideline. The goal of this document is to provide critical care practitioners with essential information and practical recommendations related to management of the potential organ donor, based on the available literature and expert consensus.
Dr Annemarie Weissenbacher, Nuffield Department of Surgical Sciences, University of Oxford, Oxford, UK.
Methodological Appraisers:
Rhiannon Deierhoi Reed, University of Alabama at Birmingham, Comprehensive Transplant Institute, USA
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
6
Recommendation for future use
Appraiser 1
Appraiser 2
Appraiser 3
Yes with modifications
No
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
5
7
2.
The health question(s) covered by the guideline is (are) specifically described
5
5
6
3.
The population (patients, public, etc.) to whom the guideline is meant to apply is specifically described
5
4
7
Domain 2 - Stakeholder Involvement
39%
Appraiser 1
Appraiser 2
Appraiser 3
4.
The guideline development group includes individuals from all the relevant professional groups
5
1
6
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
2
7
6
Domain 3 - Rigour of Development
56%
Appraiser 1
Appraiser 2
Appraiser 3
7.
Systematic methods were used to search for evidence
5
7
7
8.
The criteria for selecting the evidence are clearly described
2
4
3
9.
The strengths and limitations of the body of evidence are clearly described
6
7
7
10.
The methods for formulating the recommendations are clearly described
5
1
5
11.
The health benefits, side effects, and risks have been considered in formulating the recommendations
6
4
7
12.
There is an explicit link between the recommendations and the supporting evidence
6
6
7
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
2
Domain 4 - Clarity of Presentation
80%
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
7
7
17.
Key recommendations are easily identifiable
6
2
7
Domain 5 - Applicability
33%
Appraiser 1
Appraiser 2
Appraiser 3
18.
The guideline describes facilitators and barriers to its application
2
4
2
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
4
1
21.
The guideline presents monitoring and/ or auditing
5
1
3
Domain 6 - Editorial Independence
28%
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
5
1
7
Use of organs from donors testing positive for hepatitis B virus (HBV) may safely expand the donor pool. The American Society of Transplantation convened a multidisciplinary expert panel that reviewed the existing literature and developed consensus recommendations for recipient management following the use of organs from HBV positive donors. Transmission risk is highest with liver donors and significantly lower with non-liver (kidney and thoracic) donors. Antiviral prophylaxis significantly reduces the rate of transmission to liver recipients from isolated HBV core antibody positive (anti-HBc+) donors. Organs from anti-HBc+ donors should be considered for all adult transplant candidates after an individualized assessment of the risks and benefits and appropriate patient consent. Indefinite antiviral prophylaxis is recommended in liver recipients with no immunity or vaccine immunity but not in liver recipients with natural immunity. Antiviral prophylaxis may be considered for up to 1 year in susceptible non-liver recipients but is not recommended in immune non-liver recipients. Although no longer the treatment of choice in patients with chronic HBV, lamivudine remains the most cost-effective choice for prophylaxis in this setting. Hepatitis B immunoglobulin is not recommended.
