The psychosocial evaluation is well-recognized as an important component of the multifaceted assessment process to determine candidacy for heart transplantation, lung transplantation, and long-term mechanical circulatory support (MCS). However, there is no consensus-based set of recommendations for either the full range of psychosocial domains to be assessed during the evaluation, or the set of processes and procedures to be used to conduct the evaluation, report its findings, and monitor patients’ receipt of and response to interventions for any problems identified. This document provides recommendations on both evaluation content and process. It represents a collaborative effort of the International Society for Heart and Lung Transplantation (ISHLT) and the Academy of Psychosomatic Medicine, American Society of Transplantation, International Consortium of Circulatory Assist Clinicians, and Society for Transplant Social Workers. The Nursing, Health Science and Allied Health Council of the ISHLT organized a Writing Committee composed of international experts representing the ISHLT and the collaborating societies. This Committee synthesized expert opinion and conducted a comprehensive literature review to support the psychosocial evaluation content and process recommendations that were developed. The recommendations are intended to dovetail with current ISHLT guidelines and consensus statements for the selection of candidates for cardiothoracic transplantation and MCS implantation. Moreover, the recommendations are designed to promote consistency across programs in the performance of the psychosocial evaluation by proposing a core set of content domains and processes that can be expanded as needed to meet programs’ unique needs and goals.
Keywords
Candidates for heart transplantation, lung transplantation, and long-term mechanical circulatory support (MCS) undergo a multifaceted assessment process. The psychosocial evaluation is integral to this process for several reasons. First, it provides information relevant for the selection of patients for transplantation and MCS. Second, it enables care planning and the provision of interventions to improve patients’ viability as transplant and/or MCS candidates. Third, it facilitates referrals for care for patients deemed ineligible for transplantation or MCS. Fourth, for patients who undergo transplantation or device implantation (either as a bridge to transplantation or as permanent, “destination,” therapy), information from the psychosocial evaluation facilitates post-transplantation/post-implantation care to support optimal psychosocial and medical outcomes.
The International Society for Heart and Lung Transplantation (ISHLT), leading a collaboration with the Academy of Psychosomatic Medicine (APM), American Society of Transplantation (AST), International Consortium of Circulatory Assist Clinicians (ICCAC), and Society for Transplant Social Workers (STSW), convened a Writing Committee of international experts to produce this consensus document, which provides recommendations for: (a) the content of the psychosocial evaluation; and (b) the process of evaluation performance, reporting, and use by transplantation and MCS programs. The primary aim of the recommendations is to aid programs to construct evaluation protocols that comprehensively gather information on psychosocial factors recognized in ISHLT guidelines and consensus statements,
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and/or in the empirical literature as relevant to patient selection for transplantation or long-term MCS implantation. In addition, when psychosocial contraindications for selection are identified, the recommendations outline the implementation of referrals for treatments or interventions that may improve patients’ well-being and suitability as transplantation or MCS candidates.Need for recommendations
Pre-transplant psychosocial factors, including patients’ history of medical adherence, mental health, substance use, and social support, predict outcomes after cardiothoracic transplantation. As reviewed herein, these outcomes include post-transplant medical adherence and quality of life (QOL), as well as transplant-related morbidities and mortality. Although there are fewer studies, similar effects are observed in patients receiving long-term MCS. Transplantation and MCS programs perform evaluations to assess psychosocial factors as part of the patient selection process. However, despite recognition of the value of the psychosocial evaluation by ISHLT guidelines and consensus statements,
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these documents have not delineated the full range of psychosocial domains that should be assessed, or the set of processes and procedures to be used to conduct the evaluation, report its findings, and monitor patients’ receipt of interventions for any identified problems. To the best of our knowledge, these issues have not been fully delineated in any other published professional society guidelines or recommendations.The clinical literature developed over the past 30 years has included extensive expert advice and commentary on rationale, ethical underpinnings, and essential content of the psychosocial evaluation.
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This literature has also offered some heuristic tools to guide and summarize the evaluation.29
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In addition, there is an empirical literature that identifies psychosocial risk factors for patient outcomes, suggesting that the evaluation should include such factors. In the absence of any previous synthesis of both expert opinion and the empirical literature into a consensus-based, comprehensive set of recommendations for practice, cardiothoracic transplantation and MCS programs have been left to determine their own approach to the psychosocial evaluation. Anecdotal evidence indicates that programs—and individual psychosocial evaluators—vary in the range of psychosocial domains examined; the breadth of elements considered within each domain; and the processes used to report evaluation findings and implement evaluation recommendations.4
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Variability in content and process may contribute to inequities in care and treatment options offered to patients. Conversely, greater consistency in the psychosocial evaluation both within and across programs may promote greater equity in both candidate selection and overall patient care.How to use this document
This report represents a consensus of expert opinion and does not meet the criteria of “guidelines” as defined by the ISHLT. The Writing Committee judged that development of consensus-based recommendations was most appropriate for several reasons. First, guidance for decisions about the content and processes involved in psychosocial evaluation comes only in part from empirical literature; it also reflects expert experience. However, we note areas supported by robust empirical data in our discussion of the recommendations offered herein.
Second, the psychosocial evaluation of cardiothoracic transplantation and MCS candidates is complex because many domains of functioning and well-being are relevant for candidate selection and patient care. Moreover, the process of conducting the evaluation requires tailoring based on patients’ ability to provide requested information, given such factors as their medical status and capacity to participate actively in the evaluation. Thus, it would not be appropriate to list strict, prescriptive guidelines for universal application. Likewise, and similar to other consensus-based recommendations in the field of cardiothoracic transplantation,
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the Writing Committee asserts that the recommendations offered should not be interpreted as standard of care by health-care providers, patients, or third-party payers, or in legal proceedings. Instead, the recommendations were developed to be flexible enough to accommodate the unique aspects of each patient, and each transplantation and MCS program across a wide spectrum of health-care delivery systems. The recommendations should be used to support programs’ efforts to conduct and utilize the results of comprehensive psychosocial evaluations.Finally, it is noteworthy that the recommendations focus on psychosocial evaluation content and process issues that are independent of any psychometric instruments or measures that evaluators may choose to administer to patients as part of the evaluation. Psychometric instrumentation is an evolving field, with measures routinely undergoing revision and/or being discarded in favor of superior tools. However, the content areas that should be assessed, and basic procedures to be used in the evaluation process transcend specific psychometric instrumentation and thus are the focus of the recommendations.
Methods
At the 2015 annual scientific meeting of the ISHLT, the Nursing, Health Science and Allied Health (NHSAH) Council of the ISHLT agreed on the importance of developing consensus recommendations for the psychosocial evaluation of cardiothoracic transplantation and long-term MCS candidates. The Council solicited interest in this work from the ISHLT Standards and Guidelines Committee, and invited a Writing Committee chair who worked with the Council to propose a slate of Committee members. The Committee composition and plan of work were approved by the ISHLT Standards and Guidelines Committee in April 2016. The Writing Committee reflected diverse constituencies. It included NHSAH Council members as well as members of the ISHLT Heart Failure and Transplantation, MCS, and Pulmonary Transplantation Councils. Participation was also sought from 4 key organizations with relevant expertise: the APM, AST, ICCAC, and STSW. These organizations each approved the plan of work in April–May 2016 and contributed at least 2 representatives to the Writing Committee. In total, the Writing Committee consisted of 27 expert members and was diverse in disciplines represented (including psychology, psychiatry, nursing, social work, pharmacy, cardiology and pulmonology) and geography (with members from 23 programs across eight countries). The ISHLT Board of Directors approved the final consensus document in February 2018; each of the 4 participating organizations approved it in February-March 2018.
The Writing Committee adhered to the ISHLT Standards and Guidelines Document Development Protocol (September 2015 update). The Committee was organized into a leadership group, composed of the Committee chair and co-chairs of each of 3 Subcommittees. The Subcommittees were assigned areas of work, including: (a) synthesis of expert opinion on the content of the psychosocial evaluation; and (b) synthesis of expert opinion on the processes and procedures for conducting the evaluation, reporting its results, and implementing any additional testing or treatment; and (c) literature reviews of empirical evidence to support the Committee’s recommendations regarding both evaluation content and process.
The main strategy for the literature searches, reviewed by a medical librarian, was designed to identify empirical articles focused on psychosocial risk or protective factors for adverse post-transplantation/post-implantation clinical and behavioral outcomes (Table 1). In addition, the Committee consulted published expert reviews and commentaries. Because the consensus document provides recommendations and not guidelines, grading of levels of evidence for recommendations was not undertaken as per ISHLT Standards and Guidelines Protocol specifications.
Table 1Inclusion Criteria and Search Strategy for Empirical Evidence Supporting Consensus Recommendations
a
Although a formal systematic review or meta-analysis36 for each recommended domain of the psychosocial evaluation was not feasible within the scope of the consensus document development process, the Writing Committee performed literature searches using a consistent approach to inclusion criteria and search-term strategies for each psychosocial domain considered, as per the ISHLT Standards and Guidelines Document Development Protocol. Published systematic reviews and meta-analyses are cited where available.
| Inclusion criteria |
| Search term strategy |
| 1. Combination of: |
| (a) Terms to identify the relevant patient populations ([title words: heart transplant* or lung transplant* or heart-lung transplant* or mechanical circulatory* or ventricular assist* or circulatory support or destination therapy] OR [key words: heart transplantation or lung transplantation or heart-lung transplantation or heart-assist devices or assisted circulation or heart, artificial]). |
| and |
| (b) Terms to identify relevant post-transplant/post-implantation clinical and behavioral outcomes that could be affected by psychosocial factors ([title words: survival or morbidity or mortality or graft rejection or infection or hospitalization or cancer or adheren* or complian* or medicat* or self-manage* or self-care or health-manage* or smok* or alcohol or tobacco or substance] OR [key words: health or survival or morbidity or mortality or neoplasms or graft rejection or infection or hospitalization or arrhythmias, cardiac or hemorrhage or stroke or patient compliance or medication adherence or self-care or alcohol drinking or substance-related disorders or tobacco use or smoking or smoking cessation]). |
| and |
| (c) Additional terms iteratively identified by Writing Committee members charged with examining the literature on specific psychosocial risk factors (e.g., medical adherence history, mental health history, substance use/abuse history). The work was iterative because Committee members simultaneously discussed what domains of psychosocial factors were essential to include in the psychosocial evaluation, drawing on their own expertise and review of existing ISHLT guidelines and consensus recommendations. |
| 2. Additional articles either found in the bibliographies of identified publications or authored by or known to Committee members. Included (especially when little to no literature was identified in cardiothoracic transplantation or in MCS) were seminal empirical articles from other areas of organ transplantation and from literature on advanced heart disease and advanced lung disease populations. |
a Although a formal systematic review or meta-analysis
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for each recommended domain of the psychosocial evaluation was not feasible within the scope of the consensus document development process, the Writing Committee performed literature searches using a consistent approach to inclusion criteria and search-term strategies for each psychosocial domain considered, as per the ISHLT Standards and Guidelines Document Development Protocol. Published systematic reviews and meta-analyses are cited where available.b Required by the ISHLT Standards and Guidelines Document Development Protocol.
The Writing Committee chair, working with Subcommittee co-chairs, was responsible for organizing monthly discussions of assigned work within each Subcommittee and for evaluating the literature searches’ completeness. Each Writing Committee member reviewed and provided input on multiple drafts of all recommendations and drafts of the entire consensus document.
Recommendations for the Content of the Psychosocial Evaluation
The broad rationale for the recommended domains to be assessed in the evaluation stems from the need to:
- (a)Assess risk factors for poor post-transplantation/post-implantation outcomes.
- (b)Collect information on factors related to patients’ knowledge, understanding, and capacity to engage in decision-making about transplantation and/or MCS.
- (c)Collect information to characterize patients’ personal, social, and environmental resources and circumstances, including factors that may mitigate the impact of any psychosocial risk factors on post-transplantation/post-implantation outcomes.
- (d)Unique to MCS candidates, evaluate patients’ knowledge about and capacity to operate the device.
Table 2 lists the recommendations for evaluation content, including 10 domains and the components comprising each. Although the Committee viewed these domains and their components as essential, transplantation and MCS programs may determine that additional elements require assessment, according to local protocols and/or regulatory bodies. Table 3 summarizes the empirical evidence supporting each recommended content domain.
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, - De Geest S.
- Burkhalter H.
- Bogert L.
- et al.
Describing the evolution of medication nonadherence from pretransplant until 3 years post-transplant and determining pretransplant medication nonadherence as risk factor for post-transplant nonadherence to immunosuppressives: the Swiss Transplant Cohort Study.
Transpl Int. 2014; 27: 657-666
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Table 2Consensus Recommendations on the Content of Psychosocial Evaluation of Adult Cardiothoracic Transplant Candidates and Long-term MCS Candidates: Domains to Be Assessed and Components to be Included Within Each Domain
| Evaluation domain | Components within each domain |
|---|---|
| A. Risk factors for poor outcomes after transplantation/implantation | |
| 1. Treatment adherence and health behaviors |
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| 2. Mental health history |
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| 3. Substance use history |
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| B. Factors related to patients’ knowledge, understanding, and capacity to engage in decision-making | |
| 4. Cognitive status and capacity to give informed consent |
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| 5. Knowledge and understanding of current illness |
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| 6. Knowledge and understanding of current treatment options |
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| C. Factors specific to patients’ personal, social, and environmental resources, and circumstances | |
| 7. Coping with illness |
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| 8. Social support |
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| 9. Social history |
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| D. Factors specific to patients under consideration for MCS | |
| 10. Knowledge about and capacity to operate MCS device |
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a The order of listing of the domains to be assessed in the psychosocial evaluation is based on conceptual distinctions (see subheadings in the table) and is not meant to imply any recommendation that the domains should be assessed in this order.MCS, mechanical circulatory support.
Table 3Empirical Evidence Supporting the Inclusion of Each Domain of the Psychosocial Evaluation
| A. Risk factors for poor outcomes after transplantation/implantation |
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| B. Factors related to patients’ knowledge, understanding, and capacity to engage in decision-making |
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