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The Journal of Heart and Lung Transplantation
International Society for Heart and Lung Transplantation.

The 2018 ISHLT/APM/AST/ICCAC/STSW recommendations for the psychosocial evaluation of adult cardiothoracic transplant candidates and candidates for long-term mechanical circulatory support

  • Author Footnotes
    1 International Society for Heart and Lung Transplantation (ISHLT) representative.
    ,
    Author Footnotes
    2 Academy of Psychosomatic Medicine (APM) representative.
    ,
    Author Footnotes
    3 American Society of Transplantation (AST) representative.
    Mary Amanda Dew
    Correspondence
    Reprint requests: Mary Amanda Dew, PhD, Department of Psychiatry, University of Pittsburgh School of Medicine and Medical Center, 3811 O’Hara Street, Pittsburgh, PA 15213. Telephone: +412-624-3373. Fax: +412-586-9255.
    Footnotes
    1 International Society for Heart and Lung Transplantation (ISHLT) representative.
    2 Academy of Psychosomatic Medicine (APM) representative.
    3 American Society of Transplantation (AST) representative.
    Affiliations
    University of Pittsburgh School of Medicine and Medical Center, Pittsburgh, Pennsylvania, USA
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  • Author Footnotes
    2 Academy of Psychosomatic Medicine (APM) representative.
    Andrea F. DiMartini
    Footnotes
    2 Academy of Psychosomatic Medicine (APM) representative.
    Affiliations
    University of Pittsburgh School of Medicine and Medical Center, Pittsburgh, Pennsylvania, USA
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  • Author Footnotes
    1 International Society for Heart and Lung Transplantation (ISHLT) representative.
    Fabienne Dobbels
    Footnotes
    1 International Society for Heart and Lung Transplantation (ISHLT) representative.
    Affiliations
    Katholieke Universiteit Leuven, Leuven, Belgium
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  • Author Footnotes
    1 International Society for Heart and Lung Transplantation (ISHLT) representative.
    Kathleen L. Grady
    Footnotes
    1 International Society for Heart and Lung Transplantation (ISHLT) representative.
    Affiliations
    Northwestern University Feinberg School of Medicine, Chicago, Illinois, USA
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  • Author Footnotes
    2 Academy of Psychosomatic Medicine (APM) representative.
    ,
    Author Footnotes
    3 American Society of Transplantation (AST) representative.
    Sheila G. Jowsey-Gregoire
    Footnotes
    2 Academy of Psychosomatic Medicine (APM) representative.
    3 American Society of Transplantation (AST) representative.
    Affiliations
    Mayo Clinic, Rochester, Minnesota, USA
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  • Author Footnotes
    1 International Society for Heart and Lung Transplantation (ISHLT) representative.
    ,
    Author Footnotes
    4 International Consortium of Circulatory Assist Clinicians (ICCAC) representative.
    Annemarie Kaan
    Footnotes
    1 International Society for Heart and Lung Transplantation (ISHLT) representative.
    4 International Consortium of Circulatory Assist Clinicians (ICCAC) representative.
    Affiliations
    St. Paul’s Hospital, Vancouver, British Columbia, Canada
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  • Author Footnotes
    5 Society for Transplant Social Workers (STSW) representative.
    Kay Kendall
    Footnotes
    5 Society for Transplant Social Workers (STSW) representative.
    Affiliations
    Cleveland Clinic, Cleveland, Ohio, USA
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  • Author Footnotes
    1 International Society for Heart and Lung Transplantation (ISHLT) representative.
    Quincy-Robyn Young
    Footnotes
    1 International Society for Heart and Lung Transplantation (ISHLT) representative.
    Affiliations
    St. Paul’s Hospital, Vancouver, British Columbia, Canada
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  • Author Footnotes
    2 Academy of Psychosomatic Medicine (APM) representative.
    Susan E. Abbey
    Footnotes
    2 Academy of Psychosomatic Medicine (APM) representative.
    Affiliations
    University of Toronto and University Health Network, Toronto, Ontario, Canada
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  • Author Footnotes
    3 American Society of Transplantation (AST) representative.
    Zeeshan Butt
    Footnotes
    3 American Society of Transplantation (AST) representative.
    Affiliations
    Northwestern University Feinberg School of Medicine, Chicago, Illinois, USA
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  • Author Footnotes
    2 Academy of Psychosomatic Medicine (APM) representative.
    Catherine C. Crone
    Footnotes
    2 Academy of Psychosomatic Medicine (APM) representative.
    Affiliations
    INOVA Hospitals, Fairfax, Virginia, USA
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  • Author Footnotes
    1 International Society for Heart and Lung Transplantation (ISHLT) representative.
    Sabina De Geest
    Footnotes
    1 International Society for Heart and Lung Transplantation (ISHLT) representative.
    Affiliations
    Katholieke Universiteit Leuven, Leuven, Belgium

    University of Basel, Basel, Switzerland
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  • Author Footnotes
    1 International Society for Heart and Lung Transplantation (ISHLT) representative.
    ,
    Author Footnotes
    3 American Society of Transplantation (AST) representative.
    ,
    Author Footnotes
    6 Current affiliation: University of North Carolina, Chapel Hill, NC.
    Christina T. Doligalski
    Footnotes
    1 International Society for Heart and Lung Transplantation (ISHLT) representative.
    3 American Society of Transplantation (AST) representative.
    6 Current affiliation: University of North Carolina, Chapel Hill, NC.
    Affiliations
    Tampa General Hospital, Tampa, Florida, USA
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  • Author Footnotes
    1 International Society for Heart and Lung Transplantation (ISHLT) representative.
    Christiane Kugler
    Footnotes
    1 International Society for Heart and Lung Transplantation (ISHLT) representative.
    Affiliations
    University of Freiburg, Freiburg, Germany
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  • Author Footnotes
    5 Society for Transplant Social Workers (STSW) representative.
    Laurie McDonald
    Footnotes
    5 Society for Transplant Social Workers (STSW) representative.
    Affiliations
    University of North Carolina, Chapel Hill, North Carolina, USA
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  • Author Footnotes
    1 International Society for Heart and Lung Transplantation (ISHLT) representative.
    ,
    Author Footnotes
    7 Current affiliation: New York University Medical Center, New York, NY.
    Linda Ohler
    Footnotes
    1 International Society for Heart and Lung Transplantation (ISHLT) representative.
    7 Current affiliation: New York University Medical Center, New York, NY.
    Affiliations
    George Washington University, Washington, DC, USA
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  • Author Footnotes
    1 International Society for Heart and Lung Transplantation (ISHLT) representative.
    Liz Painter
    Footnotes
    1 International Society for Heart and Lung Transplantation (ISHLT) representative.
    Affiliations
    Auckland City Hospital, Auckland, New Zealand
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  • Author Footnotes
    1 International Society for Heart and Lung Transplantation (ISHLT) representative.
    ,
    Author Footnotes
    4 International Consortium of Circulatory Assist Clinicians (ICCAC) representative.
    Michael G. Petty
    Footnotes
    1 International Society for Heart and Lung Transplantation (ISHLT) representative.
    4 International Consortium of Circulatory Assist Clinicians (ICCAC) representative.
    Affiliations
    University of Minnesota, Minneapolis, Minnesota, USA
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  • Author Footnotes
    1 International Society for Heart and Lung Transplantation (ISHLT) representative.
    ,
    Author Footnotes
    4 International Consortium of Circulatory Assist Clinicians (ICCAC) representative.
    Desiree Robson
    Footnotes
    1 International Society for Heart and Lung Transplantation (ISHLT) representative.
    4 International Consortium of Circulatory Assist Clinicians (ICCAC) representative.
    Affiliations
    St. Vincent’s Hospital, Sydney, New South Wales, Australia
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  • Author Footnotes
    1 International Society for Heart and Lung Transplantation (ISHLT) representative.
    ,
    Author Footnotes
    4 International Consortium of Circulatory Assist Clinicians (ICCAC) representative.
    Thomas Schlöglhofer
    Footnotes
    1 International Society for Heart and Lung Transplantation (ISHLT) representative.
    4 International Consortium of Circulatory Assist Clinicians (ICCAC) representative.
    Affiliations
    Medical University of Vienna, Vienna, Austria
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  • Author Footnotes
    2 Academy of Psychosomatic Medicine (APM) representative.
    Terry D. Schneekloth
    Footnotes
    2 Academy of Psychosomatic Medicine (APM) representative.
    Affiliations
    Mayo Clinic, Rochester, Minnesota, USA
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  • Author Footnotes
    1 International Society for Heart and Lung Transplantation (ISHLT) representative.
    Jonathan P. Singer
    Footnotes
    1 International Society for Heart and Lung Transplantation (ISHLT) representative.
    Affiliations
    University of California at San Francisco, San Francisco, California, USA
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  • Author Footnotes
    1 International Society for Heart and Lung Transplantation (ISHLT) representative.
    Patrick J. Smith
    Footnotes
    1 International Society for Heart and Lung Transplantation (ISHLT) representative.
    Affiliations
    Duke University, Durham, North Carolina, USA
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  • Author Footnotes
    1 International Society for Heart and Lung Transplantation (ISHLT) representative.
    Heike Spaderna
    Footnotes
    1 International Society for Heart and Lung Transplantation (ISHLT) representative.
    Affiliations
    Trier University, Trier, Germany
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  • Author Footnotes
    1 International Society for Heart and Lung Transplantation (ISHLT) representative.
    ,
    Author Footnotes
    3 American Society of Transplantation (AST) representative.
    Jeffrey J. Teuteberg
    Footnotes
    1 International Society for Heart and Lung Transplantation (ISHLT) representative.
    3 American Society of Transplantation (AST) representative.
    Affiliations
    Stanford University, Stanford, California, USA
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  • Author Footnotes
    1 International Society for Heart and Lung Transplantation (ISHLT) representative.
    Roger D. Yusen
    Footnotes
    1 International Society for Heart and Lung Transplantation (ISHLT) representative.
    Affiliations
    Washington University, St. Louis, Missouri, USA
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  • Author Footnotes
    2 Academy of Psychosomatic Medicine (APM) representative.
    Paula C. Zimbrean
    Footnotes
    2 Academy of Psychosomatic Medicine (APM) representative.
    Affiliations
    Yale University, New Haven, Connecticut, USA
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  • Author Footnotes
    1 International Society for Heart and Lung Transplantation (ISHLT) representative.
    2 Academy of Psychosomatic Medicine (APM) representative.
    3 American Society of Transplantation (AST) representative.
    4 International Consortium of Circulatory Assist Clinicians (ICCAC) representative.
    5 Society for Transplant Social Workers (STSW) representative.
    6 Current affiliation: University of North Carolina, Chapel Hill, NC.
    7 Current affiliation: New York University Medical Center, New York, NY.
      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,
      • Mehra M.R.
      • Canter C.E.
      • Hannan M.M.
      • et al.
      The 2016 International Society for Heart Lung Transplantation listing criteria for heart transplantation: a 10-year update.
      • Weill D.
      • Benden C.
      • Corris P.A.
      • et al.
      A consensus document for the selection of lung transplant candidates: 2014—an update from the Pulmonary Transplantation Council of the International Society for Heart and Lung Transplantation.
      • Feldman D.
      • Pamboukian S.V.
      • Teuteberg J.J.
      • et al.
      The 2013 International Society for Heart and Lung Transplantation guidelines for mechanical circulatory support: Executive summary.
      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,
      • Mehra M.R.
      • Canter C.E.
      • Hannan M.M.
      • et al.
      The 2016 International Society for Heart Lung Transplantation listing criteria for heart transplantation: a 10-year update.
      • Weill D.
      • Benden C.
      • Corris P.A.
      • et al.
      A consensus document for the selection of lung transplant candidates: 2014—an update from the Pulmonary Transplantation Council of the International Society for Heart and Lung Transplantation.
      • Feldman D.
      • Pamboukian S.V.
      • Teuteberg J.J.
      • et al.
      The 2013 International Society for Heart and Lung Transplantation guidelines for mechanical circulatory support: Executive summary.
      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.
      • Barbour K.A.
      • Blumenthal J.A.
      • Palmer S.M.
      Psychosocial issues in the assessment and management of patients undergoing lung transplantation.
      • Blumenthal N.
      • Petty M.G.
      • McCorkle R.
      Missing domains of lung transplant patient selection.
      • Caro M.A.
      • Rosenthal J.L.
      • Kendall K.
      • et al.
      What the psychiatrist needs to know about ventricular assist devices: a comprehensive review.
      • Collins C.A.
      • Labott S.M.
      Psychological assessment of candidates for solid organ transplantation.
      • Crone C.C.
      • Wise T.N.
      Psychiatric aspects of transplantation. I: Evaluation and selection of candidates.
      • Dew M.A.
      • Switzer G.E.
      • DiMartini A.F.
      • et al.
      Psychosocial assessments and outcomes in organ transplantation.
      • DiMartini A.F.
      • Crone C.
      • Fireman M.
      • et al.
      Psychiatric aspects of organ transplantation in critical care.
      • DiMartini A.F.
      • Dew M.A.
      • Crone C.C.
      Organ transplantation.

      DiMartini AF, Shenoy A, Dew MA. Organ transplantation. In: Levenson JL, editor. The American Psychiatric Publishing textbook of psychosomatic medicine: psychiatric care of the medically ill. 3rd ed. Washington, DC: American Psychiatric Publishing, in press.

      • Dobbels F.
      • De Geest S.
      • Cleemput I.
      • et al.
      Psychosocial and behavioral selection criteria for solid organ transplantation.
      • Dobbels F.
      • Verleden G.
      • Dupont L.
      • et al.
      To transplant or not? The importance of psychosocial and behavioural factors before lung transplantation.
      • Eshelman A.
      • Mason S.
      • Nemeh H.
      • et al.
      LVAD destination therapy: applying what we know about psychiatric evaluation and management from cardiac failure and transplant.

      Grady KL, Dew MA. Psychosocial and quality-of-life issues in mechanical circulatory support. In: Kirklin JK, Rogers J, editors. Mechanical circulatory support: a companion to Braunwald’s Heart disease. 2nd ed. Philadelphia: Saunders; in press.

      • Jowsey S.G.
      • Taylor M.L.
      • Schneekloth T.D.
      • Clark M.M.
      Psychosocial challenges in transplantation.
      • Kay J.
      • Bienenfeld D.
      The clinical assessment of the cardiac transplant candidate.
      • Kendall K.
      • Ansley K.
      • Skillman M.
      Psychosocial issues in transplantation.
      • Klapheke M.M.
      The role of the psychiatrist in organ transplantation.
      • Kuntz K.
      • Weinland S.R.
      • Butt Z.
      Psychosocial challenges in solid organ transplantation.
      • Olbrisch M.E.
      • Benedict S.M.
      • Ashe K.
      • et al.
      Psychological assessment and care of organ transplant patients.
      • Olbrisch M.E.
      • Levenson J.L.
      Psychosocial assessment of organ transplant candidates: current status of methodological and philosophical issues.
      • Petty M.
      • Bauman L.
      Psychosocial issues in ventricular assist device implantation and management.
      • Prager L.M.
      Organ transplantation: pre-transplant assessment and post-transplant management.
      • Rivard A.L.
      • Hellmich C.
      • Sampson B.
      • et al.
      Preoperative predictors for postoperative problems in heart transplantation: psychiatric and psychosocial considerations.
      • Surman O.S.
      • Cosimi A.B.
      • DiMartini A.F.
      Psychiatric care of patients undergoing organ transplantation.
      • Zimbrean P.
      • Crone C.
      • Sher Y.
      • et al.
      Transplant psychiatry, Part 1: An introduction. Psychiatr.
      This literature has also offered some heuristic tools to guide and summarize the evaluation.
      • Maldonado J.R.
      • Dubois H.C.
      • David E.E.
      • et al.
      The Stanford Integrated Psychosocial Assessment for Transplantation (SIPAT): a new tool for the psychosocial evaluation of pre-transplant candidates.
      • Maltby M.C.
      • Flattery M.P.
      • Burns B.
      • et al.
      Psychosocial assessment of candidates and risk classification of patients considered for durable mechanical circulatory support.
      • Olbrisch M.E.
      • Levenson J.L.
      • Hamer R.
      The PACT: a rating scale for the study of clinical decision-making in psychosocial screening of organ transplant candidates.
      • Twillman R.K.
      • Manetto C.
      • Wellisch D.K.
      • et al.
      The Transplant Evaluation Rating Scale. A revision of the psychosocial levels system for evaluating organ transplant candidates.
      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.
      • Barbour K.A.
      • Blumenthal J.A.
      • Palmer S.M.
      Psychosocial issues in the assessment and management of patients undergoing lung transplantation.
      • Dew M.A.
      • Switzer G.E.
      • DiMartini A.F.
      • et al.
      Psychosocial assessments and outcomes in organ transplantation.
      • Dobbels F.
      • Verleden G.
      • Dupont L.
      • et al.
      To transplant or not? The importance of psychosocial and behavioural factors before lung transplantation.
      • Kendall K.
      • Ansley K.
      • Skillman M.
      Psychosocial issues in transplantation.
      • Kuntz K.
      • Weinland S.R.
      • Butt Z.
      Psychosocial challenges in solid organ transplantation.
      • Olbrisch M.E.
      • Benedict S.M.
      • Ashe K.
      • et al.
      Psychological assessment and care of organ transplant patients.
      • Prager L.M.
      Organ transplantation: pre-transplant assessment and post-transplant management.
      • Bruce C.R.
      • Delgado E.
      • Kostick K.
      • et al.
      Ventricular assist devices: a review of psychosocial risk factors and their impact on outcomes.
      • Corbett C.
      • Armstrong M.J.
      • Parker R.
      • et al.
      Mental health disorders and solid-organ transplant recipients.
      • Skotzko C.E.
      • Stowe J.A.
      • Wright C.
      • et al.
      Approaching a consensus: psychosocial support services for solid organ transplantation programs.
      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,
      • Weill D.
      • Benden C.
      • Corris P.A.
      • et al.
      A consensus document for the selection of lung transplant candidates: 2014—an update from the Pulmonary Transplantation Council of the International Society for Heart and Lung Transplantation.
      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
      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
      • 1.
        Peer-reviewed articles
        Required by the ISHLT Standards and Guidelines Document Development Protocol.
      • 2.
        Articles published in English
        Required by the ISHLT Standards and Guidelines Document Development Protocol.
      • 3.
        Articles focused on adults aged 18 and older
      • 4.
        Publication dates between 2000 through mid-2017, inclusive
      • 5.
        Seminal articles published before 2000 known to the Writing Committee members
      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
      • Moher D.
      • Liberati A.
      • Tetzlaff J.
      • et al.
      Preferred reporting items for sys-tematic reviews and meta-analyses: the PRISMA statement.
      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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      Psychosocial factors and quality-of-life after heart transplantation and mechanical circulatory support.
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      Depressive symptoms and all-cause mortality after heart transplantation.
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      Psychiatric predictors of long-term transplant-related outcomes in lung transplant recipients.
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      Psychosocial predictors of mortality following lung transplantation.
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      The role of depression and social isolation at time of waitlisting for survival eight years after heart transplantation.
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      Depression and anxiety as risk factors for morbidity and mortality after organ transplantation: a systematic review and meta-analysis.
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      Psychological disorders and distress after adult cardiothoracic transplantation.
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      Depressive symptoms and early mortality following lung transplantation: a pilot study.
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      Adherence to the therapeutic regimen in heart, lung, and heart-lung transplant recipients.
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      Nonadherence consensus conference summary report.
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      Palliative care and end-of-life issues in patients treated with left ventricular assist devices as destination therapy.
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      Psychosocial characteristics and outcomes in patients with left ventricular assist device implanted as destination therapy.
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      Outcomes of renal transplantation in patients with bipolar affective disorder and schizophrenia: a national retrospective cohort study.
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      Posttransplant outcomes in veterans with serious mental illness.
      • Price A.
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      Impact of psychotic disorder on transplant eligibility and outcomes.
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      Patients with psychotic disorders in solid-organ transplant.
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      Hospitalized psychoses after renal transplantation in the United States: incidence, risk factors, and prognosis.
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      Psychiatric interview and psychometric predictors of cardiac transplant survival.
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      Psychosocial evaluation and prediction of compliance problems and morbidity after heart transplantation.
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      Predictors of heavy drinking after liver transplantation for alcoholic liver disease in Denmark (1990-2013): a nationwide study with competing risks analyses.
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      Personality disorders: a challenge for transplantation.
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      Psychosocial sequelae of a heart-transplant recipient with a histrionic personality disorder.
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      Personality disorder as a contraindication for liver transplantation in alcoholic cirrhosis.
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      Examining gene-environment interplay in psychiatric disorders.
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      Prediction of treatment outcomes in psychiatry—where do we stand?.
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      • et al.
      Supporting family caregivers in providing care.
      • Botha P.
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      Smoking after cardiac transplantation.
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      Substance abuse at the time of left ventricular assist device implantation is associated with increased mortality.
      • Dew M.A.
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      Meta-analysis of risk for relapse to substance use after transplantation of the liver or other solid organs.
      • Dew M.A.
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      Rates and risk factors for nonadherence to the medical regimen after adult solid organ transplantation.
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      Correlates and outcomes of posttransplant smoking in solid organ transplant recipients: a systematic literature review and meta-analysis.
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      Smoking resumption after lung transplantation: standardised screening and importance for long-term outcome.
      • Vos R.
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      • et al.
      Long-term azithromycin therapy for bronchiolitis obliterans syndrome: divide and conquer?.
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      Lung cancer after heart transplantation: results from a large multicenter registry.
      • Gultekin B.
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      Incidence and outcomes of acute kidney injury after orthotopic cardiac transplant: a population-based cohort.
      • Na R.
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      High azathioprine dose and lip cancer risk in liver, heart, and lung transplant recipients: a population-based cohort study.
      • Nagele H.
      • Kalmar P.
      • Rodiger W.
      • et al.
      Smoking after heart transplantation: an underestimated hazard?.
      • Radovancevic B.
      • Poindexter S.
      • Birovljev S.
      • et al.
      Factors for development of accelerated coronary artery disease in cardiac transplant recipients.
      • Sanchez-Lazaro I.J.
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      • et al.
      Predictor factors for the development of arterial hypertension following heart transplantation.
      • Yagdi T.
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      Malignancy after heart transplantation: analysis of 24-year experience at a single center.
      • Barraclough K.
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      Predictors of decline in renal function after lung transplantation.
      • Dickson R.P.
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      • et al.
      High frequency of bronchogenic carcinoma after single-lung transplantation.
      • Hellemons M.E.
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      • et al.
      Former smoking is a risk factor for chronic kidney disease after lung transplantation.
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      • et al.
      Features of patients with gastrointestinal bleeding after implantation of ventricular assist devices.
      • Arora S.
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      The prognostic importance of modifiable risk factors after heart transplantation.
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      • Smith R.G.
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      • et al.
      Risk factor analysis for bridge to transplantation with the CardioWest total artificial heart.
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      Neurological complications following adult lung transplantation.
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      Outcome of heart transplants 15 to 20 years ago: graft survival, post-transplant morbidity, and risk factors for mortality.
      • Sanchez-Lazaro I.J.
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      Impact of smoking on survival after heart transplantation.
      • Rai H.S.
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      Marijuana use and organ transplantation: a review and implications for clinical practice.
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      The debate about marijuana usage in transplant candidates: recent medical evidence on marijuana health effects.
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      A microbiome assessment of medical marijuana.
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      • Greenan G.
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      • et al.
      Recreational marijuana use is not associated with worse outcomes after renal transplantation.
      • Ranney D.N.
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      • et al.
      Marijuana use in potential liver transplant candidates.
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      The recipient's heme oxygenase-1 promoter region polymorphism is associated with cardiac allograft vasculopathy.
      • Kopp B.T.
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      • et al.
      Cigarette smoking effect on survival after lung transplant in cystic fibrosis.
      • Moon S.
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      • et al.
      Risk factors and outcome of primary graft dysfunction after lung transplantation in Korea.
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      • et al.
      LVAD bloodstream infections: therapeutic rationale for transplantation after LVAD infection.
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      • et al.
      Does psychosocial compliance have an impact on long-term outcome after heart transplantation?.
      • Basile A.
      • Bernazzali S.
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      • et al.
      Risk factors for smoking abuse after heart transplantation.
      • Mehra M.R.
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      • et al.
      Recrudescent tobacco exposure following heart transplantation: clinical profiles and relationship with athero-thrombosis risk markers.
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      Epidemiology of alcohol use, abuse and dependence.
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      • Yost G.
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      • et al.
      Cognitive function, mental health, and health-related quality of life after lung transplantation.
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      • et al.
      Neuropsychological dysfunction in patients with end-stage pulmonary disease: lung transplant evaluation.
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      Cognitive function in adult cardiothoracic transplant candidates and recipients.
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      • et al.
      Psychological and cognitive status before and after heart transplantation.
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      • Blumenthal J.A.
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      Changes in neurocognitive functioning following lung transplantation.
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      The prevalence and prognostic significance of frailty in patients with advanced heart failure referred for heart transplantation.
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      • Mapelli D.
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      • Cavalli C.
      • et al.
      Clinical psychological and neuropsychological issues with left ventricular assist devices (LVADs).
      • Miller-Matero L.R.
      • Hyde-Nolan M.E.
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      • et al.
      Health literacy in patients referred for transplant: do patients have the capacity to understand?.
      • Parekh P.I.
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      • et al.
      Gas exchange and exercise capacity affect neurocognitive performance in patients with lung disease.
      • Putzke J.D.
      • Williams M.A.
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      • et al.
      Neuropsychological functioning among heart transplant candidates: a case control study.
      • Roman D.D.
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      • et al.
      Neuropsychological functioning in heart transplant candidates.
      • Smith P.J.
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      • Waters A.
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      Neurocognitive changes after lung transplantation.
      • Appelbaum P.S.
      Assessment of patients’ competence to consent to treatment.
      • Samelson-Jones E.
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      Cardiac transplantation in adult patients with mental retardation: do outcomes support consensus guidelines?.
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      Incidence and predictors of cognitive decline in patients with left ventricular assist devices.
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      • et al.
      Memory improvement following cardiac transplantation.
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      Neurocognitive assessments in advanced heart failure patients receiving continuous-flow left ventricular assist devices.
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      Cognitive impairment improves the predictive validity of physical frailty for mortality in patients with advanced heart failure referred for heart transplantation.
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      A systematic review of medication non-adherence in persons with dementia or cognitive impairment.
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      • Artinian N.T.
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      What do patients know about their heart failure?.
      • Huang B.
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      Knowledge is insufficient for self-care among heart failure patients with psychological distress.
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      • et al.
      State of the science. Promoting self-care in persons with heart failure. A statement from the American Heart Association.
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      Barriers and facilitators to self-care in chronic heart failure: a meta-synthesis of qualitative studies.
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      Evaluation of self-management interventions for chronic obstructive pulmonary disease.
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      Comprehensive self-management strategies.
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      Effectiveness of self-management interventions on mortality, hospital readmissions, chronic heart failure hospitalization rate and quality of life in patients with chronic heart failure: a systematic review.
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      • et al.
      Therapeutic patient education and all-cause mortality in patients with chronic heart failure: a propensity analysis.
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      • Koelling T.M.
      Relationship between improvements in heart failure patient disease specific knowledge and clinical events as part of a randomized controlled trial.
      • Davis L.A.
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      • et al.
      Lung transplant or bust: patients' recommendations for ideal lung transplant education.
      • Edlund J.E.
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      • Carey M.G.
      Patient understanding of potential risk and benefit with informed consent in a left ventricular assist device population: a pilot study.
      • Ivarsson B.
      • Ekmehag B.
      • Sjoberg T.
      Heart or lung transplanted patients' retrospective views on information and support while waiting for transplantation.
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      • et al.
      Assessment of patients' and caregivers' informational and decisional needs for left ventricular assist device placement: implications for informed consent and shared decision-making.
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      • et al.
      Identifying the educational needs of lung transplant recipients with cystic fibrosis.
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      • et al.
      Deciding about lung transplantation: informational needs of patients and support persons.
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      Patient perspectives on decision making in heart failure.
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      • et al.
      Decision making for destination therapy left ventricular assist devices: "there was no choice" versus "I thought about it an awful lot.".
      • Thompson J.S.
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      • et al.
      Development of a decision aid for patients with advanced heart failure considering a destination therapy left ventricular assist device.
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      Development of a decision aid for adult cystic fibrosis patients considering referral for lung transplantation.
      • Stacey D.
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      • et al.
      Decision aids for people facing health treatment or screening decisions.
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      • et al.
      Randomized trial of a decision aid for patients with cystic fibrosis considering lung transplantation.
      • Kostick K.
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      • et al.
      Development and pilot-testing of a patient decision aid for left ventricular assist device placement.
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      A multicenter trial of a shared decision support intervention for patients and their caregivers offered destination therapy for advanced heart failure: DECIDE-LVAD: rationale, design, and pilot data.
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      • et al.
      Randomized, controlled trial of an interactive videodisc decision aid for patients with ischemic heart disease.
      • Bohachick P.
      • Taylor M.V.
      • Sereika S.
      • et al.
      Social support, personal control, and psychosocial recovery following heart transplantation.
      • Dew M.A.
      • DiMartini A.F.
      • DeVito Dabbs A.J.
      • et al.
      Adherence to the medical regimen during the first two years after lung transplantation.
      • Goetzmann L.
      • Klaghofer R.
      • Wagner-Huber R.
      • et al.
      Psychosocial vulnerability predicts psychosocial outcome after an organ transplant: results of a prospective study with lung, liver, and bone-marrow patients.
      • Harper R.G.
      • Chacko R.C.
      • Kotik-Harper D.
      • et al.
      Self-report evaluation of health behavior, stress vulnerability, and medical outcome of heart transplant recipients.
      • Jowsey S.G.
      • Cutshall S.M.
      • Colligan R.C.
      • et al.
      Seligman's theory of attributional style: optimism, pessimism, and quality of life after heart transplant.
      • Leedham B.
      • Meyerowitz B.E.
      • Muirhead J.
      • et al.
      Positive expectations predict health after heart transplantation.
      • Myaskovsky L.
      • Dew M.A.
      • McNulty M.L.
      • et al.
      Trajectories of change in quality of life in 12-month survivors of lung or heart transplant.
      • Dew M.A.
      • DiMartini A.F.
      • DeVito Dabbs A.J.
      • et al.
      Onset and risk factors for anxiety and depression during the first 2 years after lung transplantation.
      • Dew M.A.
      • Roth L.H.
      • Schulberg H.C.
      • et al.
      Prevalence and predictors of depression and anxiety-related disorders during the year after heart transplantation.
      • Dobbels F.
      • De Geest S.
      • Martin S.
      • et al.
      Prevalence and correlates of depression symptoms at 10 years after heart transplantation: continuous attention required.
      • Evangelista L.S.
      • Moser D.
      • Dracup K.
      • et al.
      Functional status and perceived control influence quality of life in female heart transplant recipients.
      • Kugler J.
      • Tenderich G.
      • Stahlhut P.
      • et al.
      Emotional adjustment and perceived locus of control in heart transplant patients.
      • Sanchez R.
      • Bailles E.
      • Peri J.M.
      • et al.
      Assessment of psychosocial factors and predictors of psychopathology in a sample of heart transplantation recipients: a prospective 12-month follow-up.
      • Stilley C.S.
      • Dew M.A.
      • Stukas A.A.
      • et al.
      Psychological symptom levels and their correlates in lung and heart-lung transplant recipients.
      • Burker E.J.
      • Madan A.
      • Evon D.
      • et al.
      Educational level, coping, and psychological and physical aspects of quality of life in heart transplant candidates.
      • Burker E.J.
      • Evon D.M.
      • Sedway J.A.
      • et al.
      Appraisal and coping as predictors of psychological distress and self-reported physical disability before lung transplantation.
      • Myaskovsky L.
      • Dew M.A.
      • Switzer G.E.
      • et al.
      Quality of life and coping strategies among lung transplant candidates and their family caregivers.
      • Spaderna H.
      • Smits J.M.
      • Rahmel A.O.
      • et al.
      Psychosocial and behavioural factors in heart transplant candidates—an overview.
      • Taylor J.L.
      • Smith P.J.
      • Babyak M.A.
      • et al.
      Coping and quality of life in patients awaiting lung transplantation.
      • Burker E.J.
      • Evon D.M.
      • Galanko J.
      • et al.
      Health locus of control predicts survival after lung transplant.
      • Young L.D.
      • Schweiger J.
      • Beitzinger J.
      • et al.
      Denial in heart transplant candidates.
      • Conway A.
      • Schadewaldt V.
      • Clark R.
      • et al.
      The psychological experiences of adult heart transplant recipients: a systematic review and meta-summary of qualitative findings.
      • Abshire M.
      • Prichard R.
      • Cajita M.
      • et al.
      Adaptation and coping in patients living with an LVAD: a metasynthesis.
      • Tong A.
      • Howell M.
      • Wong G.
      • et al.
      The perspectives of kidney transplant recipients on medicine taking: a systematic review of qualitative studies.
      • Spaderna H.
      • Mendell N.R.
      • Zahn D.
      • et al.
      Social isolation and depression predict 12-month outcomes in the "waiting for a new heart study.".
      • Spaderna H.
      • Weidner G.
      • Koch K.C.
      • et al.
      Medical and psychosocial predictors of mechanical circulatory support device implantation and competing outcomes in the Waiting for a New Heart Study.
      • Weidner G.
      • Zahn D.
      • Mendell N.R.
      • et al.
      Patients' sex and emotional support as predictors of death and clinical deterioration in the Waiting for a New Heart Study: results from the 1-year follow-up.
      • DeVito Dabbs A.
      • Terhorst L.
      • Song M.K.
      • et al.
      Quality of recipient-caregiver relationship and psychological distress are correlates of self-care agency after lung transplantation.
      • Teichman B.J.
      • Burker E.J.
      • Weiner M.
      • et al.
      Factors associated with adherence to treatment regimens after lung transplantation.
      • Evon D.M.
      • Burker E.J.
      • Sedway J.A.
      • et al.
      Tobacco and alcohol use in lung transplant candidates and recipients.
      • Mollberg N.M.
      • Farjah F.
      • Howell E.
      • et al.
      Impact of primary caregivers on long-term outcomes after lung transplantation.
      • Tam V.
      • Arnaoutakis G.J.
      • George T.J.
      • et al.
      Marital status improves survival after orthotopic heart transplantation.
      • Dew M.A.
      • Kormos R.L.
      • DiMartini A.F.
      • et al.
      Prevalence and risk of depression and anxiety-related disorders during the first three years after heart transplantation.
      • Dew M.A.
      • Myaskovsky L.
      • Switzer G.E.
      • et al.
      Profiles and predictors of the course of psychological distress across four years after heart transplantation.
      • Bruce C.R.
      • Minard C.G.
      • Wilhelms L.A.
      • et al.
      Caregivers of patients with left ventricular assist devices: possible impacts on patients' mortality and Interagency Registry for Mechanically Assisted Circulatory Support–defined morbidity events.
      • Koeckert M.
      • Vining P.
      • Reyentovich A.
      • et al.
      Caregiver status and outcomes after durable left ventricular assist device implantation.
      Institute of Medicine
      • Evangelista L.S.
      • Rasmusson K.D.
      • Laramee A.S.
      • et al.
      Health literacy and the patient with heart failure—implications for patient care and research: a consensus statement of the Heart Failure Society of America.
      • Sadeghi S.
      • Brooks D.
      • Stagg-Peterson S.
      • et al.
      Growing awareness of the importance of health literacy in individuals with.
      • Wu J.R.
      • Holmes G.M.
      • DeWalt D.A.
      • et al.
      Low literacy is associated with increased risk of hospitalization and death among individuals with heart failure.
      • Cajita M.I.
      • Denhaerynck K.
      • Dobbels F.
      • et al.
      Health literacy in heart transplantation: prevalence, correlates and associations with health behaviors—findings from the international BRIGHT study.
      • Gordon E.J.
      • Wolf M.S.
      Health literacy skills of kidney transplant recipients.
      • Grady K.L.
      • Wang E.
      • Higgins R.
      • et al.
      Symptom frequency and distress from 5 to 10 years after heart transplantation.
      • Serper M.
      • Patzer R.E.
      • Reese P.P.
      • et al.
      Medication misuse, nonadherence, and clinical outcomes among liver transplant recipients.
      • Weng F.L.
      • Chandwani S.
      • Kurtyka K.M.
      • et al.
      Prevalence and correlates of medication non-adherence among kidney transplant recipients more than 6 months post-transplant: a cross-sectional study.
      • White-Williams C.
      • Grady K.L.
      • Naftel D.C.
      • et al.
      The relationship of socio-demographic factors and satisfaction with social support at five and 10 yr after heart transplantation.
      • Allen J.G.
      • Arnaoutakis G.J.
      • Orens J.B.
      • et al.
      Insurance status is an independent predictor of long-term survival after lung transplantation in the United States.
      • Allen J.G.
      • Weiss E.S.
      • Arnaoutakis G.J.
      • et al.
      Insurance and education predict long-term survival after orthotopic heart transplantation in the United States.
      • Emani S.
      • Tumin D.
      • Foraker R.E.
      • et al.
      Impact of insurance status on heart transplant wait-list mortality for patients with left ventricular assist devices.
      • Foraker R.E.
      • Tumin D.
      • Smith S.
      • et al.
      Insurance status by region at the time of heart transplantation: implications for survival.
      • Clerkin K.J.
      • Garan A.R.
      • Wayda B.
      • et al.
      Impact of socioeconomic status on patients supported with a left ventricular assist device: an analysis of the UNOS database (United Network for Organ Sharing).
      • DuBay D.A.
      • MacLennan P.A.
      • Reed R.D.
      • et al.
      Insurance type and solid organ transplantation outcomes: s historical perspective on how Medicaid expansion might impact transplantation outcomes.
      • Evans J.D.
      • Kaptoge S.
      • Caleyachetty R.
      • et al.
      Socioeconomic deprivation and survival after heart transplantation in England: an analysis of the United Kingdom Transplant Registry.
      • Merlo C.A.
      • Clark S.C.
      • Arnaoutakis G.J.
      • et al.
      National healthcare delivery systems influence lung transplant outcomes for cystic fibrosis.
      • Singh T.P.
      • Givertz M.M.
      • Semigran M.
      • et al.
      Socioeconomic position, ethnicity, and outcomes in heart transplant recipients.
      • Smith S.A.
      • Hasan A.
      • Binkley P.F.
      • et al.
      The impact of insurance and socioeconomic status on outcomes for patients with left ventricular assist devices.
      • Brown D.W.
      • Anda R.F.
      • Tiemeier H.
      • et al.
      Adverse childhood experiences and the risk of premature mortality.
      • Campbell J.A.
      • Walker R.J.
      • Egede L.E.
      Associations between adverse childhood experiences, high-risk behaviors, and morbidity in adulthood.
      • Husarewycz M.N.
      • El-Gabalawy R.
      • Logsetty S.
      • et al.
      The association between number and type of traumatic life experiences and physical conditions in a nationally representative sample.
      • Kershaw K.N.
      • Brenes G.A.
      • Charles L.E.
      • et al.
      Associations of stressful life events and social strain with incident cardiovascular disease in the Women’s Health Initiative.
      • Su S.
      • Jimenez M.P.
      • Roberts C.T.F.
      • et al.
      The role of adverse childhood experiences in cardiovascular disease risk: a review with emphasis on plausible mechanisms.
      • Kennedy C.C.
      • Zubair A.
      • Clark M.M.
      • et al.
      Childhood abuse is associated with worse survival following lung transplantation.
      • Casida J.M.
      • Peters R.M.
      • Magnan M.A.
      Self-care demands of persons living with an implantable left-ventricular assist device.
      • Gandhi J.
      • McCue A.
      • Cole R.
      Nonadherence in the advanced heart failure population.
      • Kato N.
      • Jaarsma T.
      • Ben Gal T.
      Learning self-care after left ventricular assist device implantation.
      • Slaughter M.S.
      • Pagani F.D.
      • Rogers J.G.
      • et al.
      Clinical management of continuous-flow left ventricular assist devices in advanced heart failure.
      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
      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.
      Evaluation domainComponents within each domain
      A. Risk factors for poor outcomes after transplantation/implantation
      1. Treatment adherence and health behaviors
      • Past and current level of adherence to the required medical regimen.
      • Knowledge and understanding of rationale and specific requirements of the current medical regimen (e.g., medication dosing; other self-management requirements; required clinical appointments and tests, etc.).
      • Willingness and intent to modify self-management and lifestyle behaviors to meet any changing regimen requirements.
      2. Mental health history
      • Past and current mood, anxiety, or other disorders including personality disorders.
      • Symptom severity and course, chronicity of symptoms.
      • Receipt, adherence, and response to psychiatric treatment; willingness to seek treatment.
      • Current or past suicidal ideation or self-injurious behaviors.
      • Mental health history of immediate family.
      3. Substance use history
      • Tobacco/alcohol/drug (licit and illicit) frequency, amount, duration of use, and length of abstinence.
      • Diagnosable disorder, level of impairment to health/work/relationships, legal issues.
      • Insight into any substance use problem, commitment to remain abstinent including prior attempts and periods of abstinence.
      • Prior and any current treatment for substance use, willingness to seek treatment, skills and supports for abstinence.
      • Substance use/abuse history of immediate family.
      B. Factors related to patients’ knowledge, understanding, and capacity to engage in decision-making
      4. Cognitive status and capacity to give informed consent
      • Evidence of cognitive impairment that would compromise capacity to comprehend information and engage in decision-making about treatment options.
      • Capacity to make judgments and decisions voluntarily without undue pressure from others.
      5. Knowledge and understanding of current illness
      • Knowledge and understanding of the causes and course of the organ disease to date and its impact on daily functioning and outcomes.
      • Understanding of rationale for treatments received and inadequacy of treatments to manage symptoms/disease progression.
      • Understanding of reasons for referral for transplant and/or MCS.
      6. Knowledge and understanding of current treatment options
      • Knowledge and understanding of risks and benefits of the surgical intervention under consideration (i.e., transplant, MCS).
      • Understanding of post-intervention medical regimen, self-care and lifestyle requirements.
      • Attitudes about the intervention (e.g., receptiveness, expectations, concerns/fears, reservations, values, preferences, and goals).
      C. Factors specific to patients’ personal, social, and environmental resources, and circumstances
      7. Coping with illness
      • Emotional response to illness; acceptance or denial about severity of illness, prognosis and treatment options.
      • Coping strategies used to manage illness and its impact on daily life (e.g., problem solving strategies used, reliance on others, avoidance coping).
      8. Social support
      • Availability, stability, and capacity of family and other sources to provide support.
      • Understanding and knowledge among family and other supports of treatment options and current care needs.
      • Expectations of family and other supports about care needs after intervention (i.e., transplant, MCS).
      9. Social history
      • Demographics, including religion/faith practices, education, literacy and health literacy.
      • Relationship history (e.g., marital status, other significant relationships, stability of relationships with others).
      • Employment experience and occupation.
      • Financial status, including insurance status or options for medical cost coverage, and living arrangements and number of dependents.
      • History of legal issues.
      • Concurrent life stressors and history of exposure to traumatic events.
      D. Factors specific to patients under consideration for MCS
      10. Knowledge about and capacity to operate MCS device
      • Knowledge and understanding of basic device operation, including signs of device malfunction.
      • Evidence of cognitive limitations, or physical limitations or disabilities (including sensory loss), that would compromise capacity to operate the device or to perceive and respond to device alarms.
      • Safety of the home environment for device operation, including access to a reliable source of electricity and accessibility of the home by health-care or emergency personnel.
      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
      • 1.
        Treatment adherence and health behaviors
        • Medication non-adherence before cardiothoracic and other solid-organ transplantation increases risk for post-transplant medication non-adherence,
          • 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.
          • Dobbels F.
          • Vanhaecke J.
          • Dupont L.
          • et al.
          Pretransplant predictors of posttransplant adherence and clinical outcome: an evidence base for pretransplant psychosocial screening.
          which, in turn, increases risks for acute and chronic graft rejection, and mortality.
          • Dobbels F.
          • Vanhaecke J.
          • Dupont L.
          • et al.
          Pretransplant predictors of posttransplant adherence and clinical outcome: an evidence base for pretransplant psychosocial screening.
          • Castelberry A.W.
          • Bishawi M.
          • Worni M.
          • et al.
          Medication nonadherence after lung transplantation in adult recipients.
          • De Geest S.
          • Abraham I.
          • Moons P.
          • et al.
          Late acute rejection and subclinical noncompliance with cyclosporine therapy in heart transplant recipients.
          • Dew M.A.
          • Kormos R.L.
          • Roth L.H.
          • et al.
          Early post-transplant medical compliance and mental health predict physical morbidity and mortality one to three years after heart transplantation.
          • Dobbels F.
          • De Geest S.
          • van Cleemput J.
          • et al.
          Effect of late medication non-compliance on outcome after heart transplantation: a 5-year follow-up.
          • Korb-Savoldelli V.
          • Sabatier B.
          • Gillaizeau F.
          • et al.
          Non-adherence with drug treatment after heart or lung transplantation in adults: a systematic review.
          • Morris A.A.
          • Kalogeropoulos A.P.
          • Zhao L.
          • et al.
          Race and ethnic differences in the epidemiology and risk factors for graft failure after heart transplantation.
        • Non-adherence to other components of the pre- or post-transplant regimen affects health outcomes.
          • Heart candidates with a history of general non-adherence to medical management have poorer survival post-transplant.
            • Owen J.E.
            • Bonds C.L.
            • Wellisch D.K.
            Psychiatric evaluations of heart transplant candidates: predicting post-transplant hospitalizations, rejection episodes, and survival.
          • Heart recipients less adherent to clinical follow-up or to the general medical regimen post-transplant are at elevated risk for graft rejection
            • De Geest S.
            • Dobbels F.
            • Martin S.
            • et al.
            Clinical risk associated with appointment noncompliance in heart transplant recipients.
            • Favaro A.
            • Gerosa G.
            • Caforio A.L.
            • et al.
            Posttraumatic stress disorder and depression in heart transplantation recipients: the relationship with outcome and adherence to medical treatment.
            and mortality.
            • Favaro A.
            • Gerosa G.
            • Caforio A.L.
            • et al.
            Posttraumatic stress disorder and depression in heart transplantation recipients: the relationship with outcome and adherence to medical treatment.
            • Farmer S.A.
            • Grady K.L.
            • Wang E.
            • et al.
            Demographic, psychosocial, and behavioral factors associated with survival after heart transplantation.
          • Lung recipients less adherent to home spirometry requirements are at higher risk for bronchiolitis obliterans syndrome.
            • Kugler C.
            • Fuehner T.
            • Dierich M.
            • et al.
            Effect of adherence to home spirometry on bronchiolitis obliterans and graft survival after lung transplantation.
          • MCS patients with a history of non-adherence to medical directives are at higher risk for complications such as pump thrombosis.
            • Kirklin J.K.
            • Naftel D.C.
            • Pagani F.D.
            • et al.
            Pump thrombosis in the Thoratec HeartMate II device: an update analysis of the INTERMACS Registry.
          • Poorer adherence to care requirements after MCS implantation is associated with poorer QOL.
            • Casida J.M.
            • Wu H.S.
            • Abshire M.
            • et al.
            Cognition and adherence are self-management factors predicting the quality of life of adults living with a left ventricular assist device.
      • 2.
        Mental health history
        • Depression and anxiety (both diagnosable disorders and clinically significant symptomatology) are the most common psychiatric conditions in transplant and MCS candidates and recipients.
          • Eshelman A.
          • Mason S.
          • Nemeh H.
          • et al.
          LVAD destination therapy: applying what we know about psychiatric evaluation and management from cardiac failure and transplant.
          • Corbett C.
          • Armstrong M.J.
          • Parker R.
          • et al.
          Mental health disorders and solid-organ transplant recipients.
          • Rosenberger E.M.
          • Fox K.R.
          • DiMartini A.F.
          • et al.
          Psychosocial factors and quality-of-life after heart transplantation and mechanical circulatory support.
        • Pre-transplant depression predicts mortality after cardiothoracic transplantation, as does post-transplant depression
          • Owen J.E.
          • Bonds C.L.
          • Wellisch D.K.
          Psychiatric evaluations of heart transplant candidates: predicting post-transplant hospitalizations, rejection episodes, and survival.
          • Havik O.E.
          • Sivertsen B.
          • Relbo A.
          • et al.
          Depressive symptoms and all-cause mortality after heart transplantation.
          • Rosenberger E.M.
          • DiMartini A.F.
          • DeVito Dabbs A.J.
          • et al.
          Psychiatric predictors of long-term transplant-related outcomes in lung transplant recipients.
          • Smith P.J.
          • Blumenthal J.A.
          • Trulock E.P.
          • et al.
          Psychosocial predictors of mortality following lung transplantation.
          • Spaderna H.
          • Zittermann A.
          • Reichenspurner H.
          • et al.
          The role of depression and social isolation at time of waitlisting for survival eight years after heart transplantation.
          ; these effects are seen in other types of solid-organ transplantation as well.
          • Dew M.A.
          • Rosenberger E.M.
          • Myaskovsky L.
          • et al.
          Depression and anxiety as risk factors for morbidity and mortality after organ transplantation: a systematic review and meta-analysis.
          Pre-transplant depression is a strong predictor of post-transplant depression.
          • Corbett C.
          • Armstrong M.J.
          • Parker R.
          • et al.
          Mental health disorders and solid-organ transplant recipients.
          • Dew M.A.
          • DiMartini A.F.
          Psychological disorders and distress after adult cardiothoracic transplantation.
        • Anxiety may predict post-transplant mortality, but the evidence base is small and not definitive.
          • Dew M.A.
          • Rosenberger E.M.
          • Myaskovsky L.
          • et al.
          Depression and anxiety as risk factors for morbidity and mortality after organ transplantation: a systematic review and meta-analysis.
        • Depression likely affects mortality in part through behavioral pathways.
          • Dew M.A.
          • Rosenberger E.M.
          • Myaskovsky L.
          • et al.
          Depression and anxiety as risk factors for morbidity and mortality after organ transplantation: a systematic review and meta-analysis.
          • Smith P.J.
          • Blumenthal J.A.
          • Snyder L.D.
          • et al.
          Depressive symptoms and early mortality following lung transplantation: a pilot study.
          In cardiothoracic transplant and MCS patients:
          • Depression is associated with poorer medical adherence, poorer coping strategies, and higher risks for complications, such as infections.
            • Owen J.E.
            • Bonds C.L.
            • Wellisch D.K.
            Psychiatric evaluations of heart transplant candidates: predicting post-transplant hospitalizations, rejection episodes, and survival.
            • Dew M.A.
            • DiMartini A.F.
            Psychological disorders and distress after adult cardiothoracic transplantation.
            • De Geest S.
            • Dobbels F.
            • Fluri C.
            • et al.
            Adherence to the therapeutic regimen in heart, lung, and heart-lung transplant recipients.
            • Fine R.N.
            • Becker Y.
            • De Geest S.
            • et al.
            Nonadherence consensus conference summary report.
            • Gordon R.J.
            • Weinberg A.D.
            • Pagani F.D.
            • et al.
            Prospective, multicenter study of ventricular assist device infections.
            • Swetz K.M.
            • Ottenberg A.L.
            • Freeman M.R.
            • et al.
            Palliative care and end-of-life issues in patients treated with left ventricular assist devices as destination therapy.
          • Such intermediate outcomes, in turn, increase risks for rehospitalization, graft rejection and loss, and mortality.
            • Castelberry A.W.
            • Bishawi M.
            • Worni M.
            • et al.
            Medication nonadherence after lung transplantation in adult recipients.
            • Favaro A.
            • Gerosa G.
            • Caforio A.L.
            • et al.
            Posttraumatic stress disorder and depression in heart transplantation recipients: the relationship with outcome and adherence to medical treatment.
            • Farmer S.A.
            • Grady K.L.
            • Wang E.
            • et al.
            Demographic, psychosocial, and behavioral factors associated with survival after heart transplantation.
            • Rosenberger E.M.
            • DiMartini A.F.
            • DeVito Dabbs A.J.
            • et al.
            Psychiatric predictors of long-term transplant-related outcomes in lung transplant recipients.
            • Smith P.J.
            • Blumenthal J.A.
            • Trulock E.P.
            • et al.
            Psychosocial predictors of mortality following lung transplantation.
            • Snipelsky D.
            • Stulak J.M.
            • Schettle S.D.
            • et al.
            Psychosocial characteristics and outcomes in patients with left ventricular assist device implanted as destination therapy.
        • A small literature on epidemiologically rare psychiatric disorders (psychosis, bipolar disorder), including some reports on cardiothoracic transplant recipients, finds that these disorders do not commonly have any impact on risk for graft rejection, other morbidities, or mortality.
          • Butler M.I.
          • McCartan D.
          • Cooney A.
          • et al.
          Outcomes of renal transplantation in patients with bipolar affective disorder and schizophrenia: a national retrospective cohort study.
          • Coffman K.L.
          • Crone C.
          Rational guidelines for transplantation in patients with psychotic disorders.
          • Evans L.D.
          • Stock E.M.
          • Zeber J.E.
          • et al.
          Posttransplant outcomes in veterans with serious mental illness.
          • Price A.
          • Whitwell S.
          • Henderson M.
          Impact of psychotic disorder on transplant eligibility and outcomes.
          • Zimbrean P.
          • Emre S.
          Patients with psychotic disorders in solid-organ transplant.
          • Such findings may be due to careful screening of such patients for transplantation, and close management thereafter.
            • Surman O.S.
            • Cosimi A.B.
            • DiMartini A.F.
            Psychiatric care of patients undergoing organ transplantation.
          • However, if management cannot be optimized, transplant outcomes can be adversely affected: risks for graft loss and mortality were increased in kidney recipients who required hospitalization for psychosis.
            • Abbott K.C.
            • Agodoa L.Y.
            • O’Malley P.G.
            Hospitalized psychoses after renal transplantation in the United States: incidence, risk factors, and prognosis.
        • A small literature suggests that personality disorders do not directly increase risk for post-transplant mortality,
          • Chacko R.C.
          • Harper R.G.
          • Gotto J.
          • et al.
          Psychiatric interview and psychometric predictors of cardiac transplant survival.
          • Shapiro P.A.
          • Williams D.L.
          • Foray A.T.
          • et al.
          Psychosocial evaluation and prediction of compliance problems and morbidity after heart transplantation.
          but may have indirect effects.
          • Personality disorders can increase the likelihood of maladaptive coping patterns and non-adherence, including return to substance use, in organ recipients.
            • Shapiro P.A.
            • Williams D.L.
            • Foray A.T.
            • et al.
            Psychosocial evaluation and prediction of compliance problems and morbidity after heart transplantation.
            • Askgaard G.
            • Tolstrup J.S.
            • Gerds T.A.
            • et al.
            Predictors of heavy drinking after liver transplantation for alcoholic liver disease in Denmark (1990-2013): a nationwide study with competing risks analyses.
            • Dobbels F.
            • Put C.
            • Vanhaecke J.
            Personality disorders: a challenge for transplantation.
            • Smith C.
            • Kesinger S.
            • Nelson D.
            • et al.
            Psychosocial sequelae of a heart-transplant recipient with a histrionic personality disorder.
          • Transplant recipients with personality disorders can have poor interpersonal relationships, thus decreasing the likelihood that they will have stable social support.
            • Yates W.R.
            • LaBrecque D.R.
            • Pfab D.
            Personality disorder as a contraindication for liver transplantation in alcoholic cirrhosis.
        • Family mental health history is rarely studied in transplant populations but is an established risk factor for many psychiatric disorders.
          • Allardyce J.
          • van Os J.
          Examining gene-environment interplay in psychiatric disorders.
          Family history can predict disorder course and what treatment is likely to be most effective.
          • McMahon F.J.
          Prediction of treatment outcomes in psychiatry—where do we stand?.
          Mental health problems and distress among family members may impair their ability to provide care and social support to the patient.
          • Reinhard S.C.
          • Given B.
          • Petlick N.H.
          • et al.
          Supporting family caregivers in providing care.
      • 3.
        Substance use history
        • Tobacco use and alcohol/drug abuse before cardiothoracic transplantation or MCS implantation increases the risk for use of these substances after transplantation/implantation.
          • Snipelsky D.
          • Stulak J.M.
          • Schettle S.D.
          • et al.
          Psychosocial characteristics and outcomes in patients with left ventricular assist device implanted as destination therapy.
          • Botha P.
          • Peaston R.
          • White K.
          • et al.
          Smoking after cardiac transplantation.
          • Cogswell R.
          • Smith E.
          • Hamel A.
          • et al.
          Substance abuse at the time of left ventricular assist device implantation is associated with increased mortality.
          • Dew M.A.
          • DiMartini A.F.
          • Steel J.
          • et al.
          Meta-analysis of risk for relapse to substance use after transplantation of the liver or other solid organs.
          • Dew M.A.
          • DiMartini A.F.
          • DeVito Dabbs A.
          • et al.
          Rates and risk factors for nonadherence to the medical regimen after adult solid organ transplantation.
          • Duerinckx N.
          • Burkhalter H.
          • Engberg S.J.
          • et al.
          Correlates and outcomes of posttransplant smoking in solid organ transplant recipients: a systematic literature review and meta-analysis.
          • Ruttens D.
          • Verleden S.E.
          • Goeminne P.C.
          • et al.
          Smoking resumption after lung transplantation: standardised screening and importance for long-term outcome.
          • Vos R.
          • Vanaudenaerde B.M.
          • Ottevaere A.
          • et al.
          Long-term azithromycin therapy for bronchiolitis obliterans syndrome: divide and conquer?.
        • Smoking tobacco increases the risks for post-transplant/post-implantation morbidities and mortality, including:
          • Cardiac allograft disease, cancers, hypertension, and acute kidney injury in heart recipients.
            • Crespo-Leiro M.G.
            • Villa-Arranz A.
            • Manito-Lorite N.
            • et al.
            Lung cancer after heart transplantation: results from a large multicenter registry.
            • Gultekin B.
            • Beyazpinar D.S.
            • Ersoy O.
            • et al.
            Incidence and outcomes of acute kidney injury after orthotopic cardiac transplant: a population-based cohort.
            • Na R.
            • Laaksonen M.A.
            • Grulich A.E.
            • et al.
            High azathioprine dose and lip cancer risk in liver, heart, and lung transplant recipients: a population-based cohort study.
            • Nagele H.
            • Kalmar P.
            • Rodiger W.
            • et al.
            Smoking after heart transplantation: an underestimated hazard?.
            • Radovancevic B.
            • Poindexter S.
            • Birovljev S.
            • et al.
            Factors for development of accelerated coronary artery disease in cardiac transplant recipients.
            • Sanchez-Lazaro I.J.
            • Martinez-Dolz L.
            • Almenar-Bonet L.
            • et al.
            Predictor factors for the development of arterial hypertension following heart transplantation.
            • Yagdi T.
            • Sharples L.
            • Tsui S.
            • et al.
            Malignancy after heart transplantation: analysis of 24-year experience at a single center.
          • Cancers and kidney disease in lung recipients.
            • Ruttens D.
            • Verleden S.E.
            • Goeminne P.C.
            • et al.
            Smoking resumption after lung transplantation: standardised screening and importance for long-term outcome.
            • Na R.
            • Laaksonen M.A.
            • Grulich A.E.
            • et al.
            High azathioprine dose and lip cancer risk in liver, heart, and lung transplant recipients: a population-based cohort study.
            • Barraclough K.
            • Menahem S.A.
            • Bailey M.
            • et al.
            Predictors of decline in renal function after lung transplantation.
            • Dickson R.P.
            • Davis R.D.
            • Rea J.B.
            • et al.
            High frequency of bronchogenic carcinoma after single-lung transplantation.
            • Hellemons M.E.
            • Agarwal P.K.
            • van der Bij W.
            • et al.
            Former smoking is a risk factor for chronic kidney disease after lung transplantation.
            • Singh G.
            • Albeldawi M.
            • Kalra S.S.
            • et al.
            Features of patients with gastrointestinal bleeding after implantation of ventricular assist devices.
            • Arora S.
            • Aukrust P.
            • Andreassen A.
            • et al.
            The prognostic importance of modifiable risk factors after heart transplantation.
          • Pump thrombosis and gastrointestinal bleeding in MCS recipients.
            • Kirklin J.K.
            • Naftel D.C.
            • Pagani F.D.
            • et al.
            Pump thrombosis in the Thoratec HeartMate II device: an update analysis of the INTERMACS Registry.
            • Singh G.
            • Albeldawi M.
            • Kalra S.S.
            • et al.
            Features of patients with gastrointestinal bleeding after implantation of ventricular assist devices.
          • Mortality in transplant and MCS recipients.
            • Nagele H.
            • Kalmar P.
            • Rodiger W.
            • et al.
            Smoking after heart transplantation: an underestimated hazard?.
            • Arora S.
            • Aukrust P.
            • Andreassen A.
            • et al.
            The prognostic importance of modifiable risk factors after heart transplantation.
            • Copeland J.G.
            • Smith R.G.
            • Bose R.K.
            • et al.
            Risk factor analysis for bridge to transplantation with the CardioWest total artificial heart.
            • Mateen F.J.
            • Dierkhising R.A.
            • Rabinstein A.A.
            • et al.
            Neurological complications following adult lung transplantation.
            • Roussel J.C.
            • Baron O.
            • Perigaud C.
            • et al.
            Outcome of heart transplants 15 to 20 years ago: graft survival, post-transplant morbidity, and risk factors for mortality.
            • Sanchez-Lazaro I.J.
            • Almenar L.
            • Martinez-Dolz L.
            • et al.
            Impact of smoking on survival after heart transplantation.
        • Alcohol abuse and drug abuse increase the risks for post-transplant/post-implantation morbidities and mortality, including:
          • Drive-line infections and hospital readmissions in MCS recipients.
            • Snipelsky D.
            • Stulak J.M.
            • Schettle S.D.
            • et al.
            Psychosocial characteristics and outcomes in patients with left ventricular assist device implanted as destination therapy.
            • Cogswell R.
            • Smith E.
            • Hamel A.
            • et al.
            Substance abuse at the time of left ventricular assist device implantation is associated with increased mortality.
          • Mortality in transplant and MCS recipients.
            • Owen J.E.
            • Bonds C.L.
            • Wellisch D.K.
            Psychiatric evaluations of heart transplant candidates: predicting post-transplant hospitalizations, rejection episodes, and survival.
            • Cogswell R.
            • Smith E.
            • Hamel A.
            • et al.
            Substance abuse at the time of left ventricular assist device implantation is associated with increased mortality.
        • Heavy inhaled cannabis use in organ transplant recipients has been linked to increased post-transplant infection risks in case reports;
          • Rai H.S.
          • Winder G.S.
          Marijuana use and organ transplantation: a review and implications for clinical practice.
          • Coffman K.L.
          The debate about marijuana usage in transplant candidates: recent medical evidence on marijuana health effects.
          inhaled/vaporized marijuana may be the source of fungal lung infections.
          • Thompson 3rd, G.R.
          • Tuscano J.M.
          • Dennis M.
          • et al.
          A microbiome assessment of medical marijuana.
          Cannabis may alter the metabolism of immunosuppressive medications but insufficient in vivo data exist to confirm this effect.
          • Stout S.M.
          • Cimino N.M.
          Exogenous cannabinoids as substrates, inhibitors, and inducers of human drug metabolizing enzymes: a systematic review.
          Cohort studies in kidney recipients and liver recipients have not demonstrated associations between marijuana use pre- or post-transplant and survival rates or (in kidney recipients) indices of graft function.
          • Rai H.S.
          • Winder G.S.
          Marijuana use and organ transplantation: a review and implications for clinical practice.
          • Greenan G.
          • Ahmad S.B.
          • Anders M.G.
          • et al.
          Recreational marijuana use is not associated with worse outcomes after renal transplantation.
          • Ranney D.N.
          • Acker W.B.
          • Al-Holou S.N.
          • et al.
          Marijuana use in potential liver transplant candidates.
        • Some studies did not find substance use/abuse to be associated with clinical outcomes after transplantation/implantation.
          • Dobbels F.
          • Vanhaecke J.
          • Dupont L.
          • et al.
          Pretransplant predictors of posttransplant adherence and clinical outcome: an evidence base for pretransplant psychosocial screening.
          • Freystaetter K.
          • Andreas M.
          • Bilban M.
          • et al.
          The recipient's heme oxygenase-1 promoter region polymorphism is associated with cardiac allograft vasculopathy.
          • Kopp B.T.
          • Groner J.
          • Tobias J.D.
          • et al.
          Cigarette smoking effect on survival after lung transplant in cystic fibrosis.
          • Moon S.
          • Park M.S.
          • Lee J.G.
          • et al.
          Risk factors and outcome of primary graft dysfunction after lung transplantation in Korea.
          • Poston R.S.
          • Husain S.
          • Sorce D.
          • et al.
          LVAD bloodstream infections: therapeutic rationale for transplantation after LVAD infection.
          • Sponga S.
          • Travaglini C.
          • Pisa F.
          • et al.
          Does psychosocial compliance have an impact on long-term outcome after heart transplantation?.
          This may reflect programs’ selection criteria and requirements regarding abstinence from use.
          • Bruce C.R.
          • Delgado E.
          • Kostick K.
          • et al.
          Ventricular assist devices: a review of psychosocial risk factors and their impact on outcomes.
          • Dobbels F.
          • Vanhaecke J.
          • Dupont L.
          • et al.
          Pretransplant predictors of posttransplant adherence and clinical outcome: an evidence base for pretransplant psychosocial screening.
          • Kopp B.T.
          • Groner J.
          • Tobias J.D.
          • et al.
          Cigarette smoking effect on survival after lung transplant in cystic fibrosis.
        • Abstinence affects risks:
          • The shorter the period of abstinence from tobacco use before heart, lung or other types of transplantation, the higher the risk of relapse post-transplant.
            • Duerinckx N.
            • Burkhalter H.
            • Engberg S.J.
            • et al.
            Correlates and outcomes of posttransplant smoking in solid organ transplant recipients: a systematic literature review and meta-analysis.
            • Ruttens D.
            • Verleden S.E.
            • Goeminne P.C.
            • et al.
            Smoking resumption after lung transplantation: standardised screening and importance for long-term outcome.
            • Vos R.
            • Vanaudenaerde B.M.
            • Ottevaere A.
            • et al.
            Long-term azithromycin therapy for bronchiolitis obliterans syndrome: divide and conquer?.
            • Basile A.
            • Bernazzali S.
            • Diciolla F.
            • et al.
            Risk factors for smoking abuse after heart transplantation.
            • Mehra M.R.
            • Uber P.A.
            • Prasad A.
            • et al.
            Recrudescent tobacco exposure following heart transplantation: clinical profiles and relationship with athero-thrombosis risk markers.
          • While duration of abstinence from alcohol/drug use has received little empirical attention in cardiothoracic transplantation or MCS, it is a strong predictor of relapse to use in other types of solid-organ transplantation.
            • Dew M.A.
            • DiMartini A.F.
            • Steel J.
            • et al.
            Meta-analysis of risk for relapse to substance use after transplantation of the liver or other solid organs.
        • Alcohol and drug abuse run in families,
          • Dawson D.A.
          • Hingson R.W.
          • Grant B.F.
          Epidemiology of alcohol use, abuse and dependence.
          and increase the risk for relapse to substance use in transplant populations.
          • Dew M.A.
          • DiMartini A.F.
          • Steel J.
          • et al.
          Meta-analysis of risk for relapse to substance use after transplantation of the liver or other solid organs.
      B. Factors related to patients’ knowledge, understanding, and capacity to engage in decision-making
      • 4.
        Cognitive status and capacity to give informed consent
        • At least some cognitive impairment is common in patients being evaluated for cardiothoracic transplant and/or MCS.
          • Bhat G.
          • Yost G.
          • Mahoney E.
          Cognitive function and left ventricular assist device implantation.
          • Cohen D.G.
          • Christie J.D.
          • Anderson B.J.
          • et al.
          Cognitive function, mental health, and health-related quality of life after lung transplantation.
          • Crews Jr, W.D.
          • Jefferson A.L.
          • Broshek D.K.
          • et al.
          Neuropsychological dysfunction in patients with end-stage pulmonary disease: lung transplant evaluation.
          • Cupples S.A.
          • Stilley C.S.
          Cognitive function in adult cardiothoracic transplant candidates and recipients.
          • Deshields T.L.
          • McDonough E.M.
          • Mannen R.K.
          • et al.
          Psychological and cognitive status before and after heart transplantation.
          • Hoffman B.M.
          • Blumenthal J.A.
          • Carney R.C.
          • et al.
          Changes in neurocognitive functioning following lung transplantation.
          • Jha S.R.
          • Hannu M.K.
          • Chang S.
          • et al.
          The prevalence and prognostic significance of frailty in patients with advanced heart failure referred for heart transplantation.
          • Mapelli D.
          • Bardi L.
          • Mojoli M.
          • et al.
          Neuropsychological profile in a large group of heart transplant candidates.
          • Mapelli D.
          • Cavazzana A.
          • Cavalli C.
          • et al.
          Clinical psychological and neuropsychological issues with left ventricular assist devices (LVADs).
          • Miller-Matero L.R.
          • Hyde-Nolan M.E.
          • Eshelman A.
          • et al.
          Health literacy in patients referred for transplant: do patients have the capacity to understand?.
          • Parekh P.I.
          • Blumenthal J.A.
          • Babyak M.A.
          • et al.
          Gas exchange and exercise capacity affect neurocognitive performance in patients with lung disease.
          • Putzke J.D.
          • Williams M.A.
          • Daniel J.F.
          • et al.
          Neuropsychological functioning among heart transplant candidates: a case control study.
          • Roman D.D.
          • Holker E.G.
          • Missov E.
          • et al.
          Neuropsychological functioning in heart transplant candidates.
          • Smith P.J.
          • Rivelli S.
          • Waters A.
          • et al.
          Neurocognitive changes after lung transplantation.
          However, absent moderate or severe dementia, other conditions including milder cognitive impairment and transient conditions (e.g., delirium/encephalopathy) that resolve do not necessarily preclude capacity to give informed consent.
          • Appelbaum P.S.
          Assessment of patients’ competence to consent to treatment.
        • A small literature suggests that patients with intellectual disabilities can achieve medical outcomes after solid-organ transplantation similar to other patients, provided they have the social support necessary for medical adherence.
          • Rosenberger E.M.
          • Fox K.R.
          • DiMartini A.F.
          • et al.
          Psychosocial factors and quality-of-life after heart transplantation and mechanical circulatory support.
          • Samelson-Jones E.
          • Mancini D.M.
          • Shapiro P.A.
          Cardiac transplantation in adult patients with mental retardation: do outcomes support consensus guidelines?.
        • Aside from its role in capacity to give consent, cognitive status can affect cardiothoracic transplant and MCS patient outcomes.
          • Cognitive functioning can improve with transplantation/implantation
            • Bhat G.
            • Yost G.
            • Mahoney E.
            Cognitive function and left ventricular assist device implantation.
            • Deshields T.L.
            • McDonough E.M.
            • Mannen R.K.
            • et al.
            Psychological and cognitive status before and after heart transplantation.
            • Hoffman B.M.
            • Blumenthal J.A.
            • Carney R.C.
            • et al.
            Changes in neurocognitive functioning following lung transplantation.
            • Fendler T.J.
            • Spertus J.A.
            • Gosch K.L.
            • et al.
            Incidence and predictors of cognitive decline in patients with left ventricular assist devices.
            • Smith P.J.
            • Blumenthal J.A.
            • Carney R.M.
            • et al.
            Neurobehavioral functioning and survival following lung transplantation.
            • Slaughter M.S.
            • Sobieski M.A.
            • Gallagher C.
            • Dia M.
            • Silver M.A.
            Low incidence of neurological events during long-term support with the HeartMate XVE left ventricular assist device.
            • Roman D.D.
            • Kubo S.H.
            • Ormaza S.
            • et al.
            Memory improvement following cardiac transplantation.
            and show continued gains over time.
            • Mapelli D.
            • Cavazzana A.
            • Cavalli C.
            • et al.
            Clinical psychological and neuropsychological issues with left ventricular assist devices (LVADs).
            • Petrucci R.J.
            • Wright S.
            • Naka Y.
            • et al.
            Neurocognitive assessments in advanced heart failure patients receiving continuous-flow left ventricular assist devices.
            • Petrucci R.J.
            • Rogers J.G.
            • Blue L.
            • et al.
            Neurocognitive function in destination therapy patients receiving continuous-flow vs pulsatile-flow left ventricular assist device support.
            However, some impairments may remain and/or worsen in the long term.
            • Cohen D.G.
            • Christie J.D.
            • Anderson B.J.
            • et al.
            Cognitive function, mental health, and health-related quality of life after lung transplantation.
            • Hoffman B.M.
            • Blumenthal J.A.
            • Carney R.C.
            • et al.
            Changes in neurocognitive functioning following lung transplantation.
            • Fendler T.J.
            • Spertus J.A.
            • Gosch K.L.
            • et al.
            Incidence and predictors of cognitive decline in patients with left ventricular assist devices.
            • Burker B.S.
            • Gullestad L.
            • Gude E.
            • et al.
            Cognitive function after heart transplantation: comparing everolimus-based and calcineurin inhibitor-based regimens.
            • Dew M.A.
            • Kormos R.L.
            • Winowich S.
            • et al.
            Quality of life outcomes after heart transplantation in individuals bridged to transplant with ventricular assist devices.
          • Greater cognitive impairment increases mortality risk both before and after cardiothoracic transplantation.
            • Smith P.J.
            • Blumenthal J.A.
            • Carney R.M.
            • et al.
            Neurobehavioral functioning and survival following lung transplantation.
            • Jha S.R.
            • Hannu M.K.
            • Gore K.
            • et al.
            Cognitive impairment improves the predictive validity of physical frailty for mortality in patients with advanced heart failure referred for heart transplantation.
          • Cognitive impairment increases risk for medication non-adherence in community samples;
            • Smith D.
            • Lovell J.
            • Weller C.
            • et al.
            A systematic review of medication non-adherence in persons with dementia or cognitive impairment.
            and in patients undergoing evaluation for cardiothoracic transplantation, it is associated with impairments in activities of daily living, including medication management and treatment regimen adherence.
            • Alosco M.L.
            • Spitznagel M.B.
            • Cohen R.
            • et al.
            Cognitive impairment is independently associated with reduced instrumental activities of daily living in persons with heart failure.
            • Alosco M.L.
            • Spitznagel M.B.
            • van Dulmen M.
            • et al.
            Cognitive function and treatment adherence in older adults with heart failure.
            • Hawkins L.A.
            • Kilian S.
            • Firek A.
            • et al.
            Cognitive impairment and medication adherence in outpatients with heart failure.
            • Putzke J.D.
            • Williams M.A.
            • Daniel F.J.
            • et al.
            Activities of daily living among heart transplant candidates: neuropsychological and cardiac function predictors.
          • In MCS patients, poorer cognitive function has been associated with reduced confidence in ability to manage the regimen and poorer QOL, but not with poorer medical adherence.
            • Casida J.M.
            • Wu H.S.
            • Abshire M.
            • et al.
            Cognition and adherence are self-management factors predicting the quality of life of adults living with a left ventricular assist device.
            The latter result may have been due to related findings that more cognitively impaired patients relied more heavily on others for their care.
            • Casida J.M.
            • Wu H.S.
            • Abshire M.
            • et al.
            Cognition and adherence are self-management factors predicting the quality of life of adults living with a left ventricular assist device.
      • 5.
        Knowledge and understanding of current illness
        • Level of knowledge in patients with advanced heart or lung disease (some of whom are considering transplantation) has frequently been found to be deficient.
          • Artinian N.T.
          • Magnan M.
          • Christian W.
          • et al.
          What do patients know about their heart failure?.
          • Huang B.
          • Moser D.
          • Dracup K.
          Knowledge is insufficient for self-care among heart failure patients with psychological distress.
          • Kessler R.
          • Stahl E.
          • Vogelmeier C.
          • et al.
          Patient understanding, detection, and experience of COPD exacerbations: an observational, interview-based study.
          • Sawicki G.S.
          • Sellers D.E.
          • McGuffie K.
          • et al.
          Adults with cystic fibrosis report important and unmet needs for disease information.
          Patients often report uncertainty about disease course and prognosis.
          • Sawicki G.S.
          • Sellers D.E.
          • McGuffie K.
          • et al.
          Adults with cystic fibrosis report important and unmet needs for disease information.
          • Allen L.A.
          • Stevenson L.W.
          • Grady K.L.
          • et al.
          Decision making in advanced heart failure. A scientific statement from the American Heart Association.
          • Allen L.A.
          • Yager J.
          • Funk M.J.
          • et al.
          Discordance between patient-predicted and model-predicted life expectancy among ambulatory patients with heart failure.
        • Inadequate knowledge and understanding is associated with poorer self-care and medical adherence.
          • Barnason S.
          • Zimmerman L.
          • Young L.
          An integrative review of interventions promoting self-care of patients with heart failure.
          • Bourbeau J.
          • Bartlett S.J.
          Patient adherence in COPD.
          • Macabasco-O’Connell A.
          • DeWalt D.A.
          • Brouksou K.A.
          • et al.
          Relationship between literacy, knowledge, self-care behaviors, and heart failure-related quality of life among patients with heart failure.
          • Reigel B.
          • Moser D.
          • Anker S.
          • et al.
          State of the science. Promoting self-care in persons with heart failure. A statement from the American Heart Association.
          • Siabani S.
          • Leeder S.R.
          • Davidson P.M.
          Barriers and facilitators to self-care in chronic heart failure: a meta-synthesis of qualitative studies.
        • Higher levels of knowledge in advanced heart or lung disease patients, including MCS candidates, can lead to improved self-care and thereby to fewer hospital readmissions, reduced mortality, and better psychosocial and QOL outcomes.
          • Maltby M.C.
          • Flattery M.P.
          • Burns B.
          • et al.
          Psychosocial assessment of candidates and risk classification of patients considered for durable mechanical circulatory support.
          • Bentsen S.B.
          • Langeland E.
          • Holm A.L.
          Evaluation of self-management interventions for chronic obstructive pulmonary disease.
          • Bourbeau J.
          • Lavoie K.L.
          • Sedeno M.
          Comprehensive self-management strategies.
          • Boyde M.
          • Turner C.
          • Thompson D.R.
          • Stewart S.
          Educational interventions for patients with heart failure. A systematic review of randomized controlled trials.
          • Ditewig J.B.
          • Blok H.
          • Havers J.
          • et al.
          Effectiveness of self-management interventions on mortality, hospital readmissions, chronic heart failure hospitalization rate and quality of life in patients with chronic heart failure: a systematic review.
          • Juilliere Y.
          • Jourdain P.
          • Suty-Selton C.
          • et al.
          Therapeutic patient education and all-cause mortality in patients with chronic heart failure: a propensity analysis.
          • Kommuri N.V.
          • Johnson M.L.
          • Koelling T.M.
          Relationship between improvements in heart failure patient disease specific knowledge and clinical events as part of a randomized controlled trial.
      • 6.
        Knowledge and understanding of current treatment options
        • Patients report gaps in understanding the range of treatment options and associated risks and benefits,
          • Davis L.A.
          • Ryszkiewicz E.
          • Schenk E.
          • et al.
          Lung transplant or bust: patients' recommendations for ideal lung transplant education.
          • Edlund J.E.
          • Edlund A.E.
          • Carey M.G.
          Patient understanding of potential risk and benefit with informed consent in a left ventricular assist device population: a pilot study.
          • Ivarsson B.
          • Ekmehag B.
          • Sjoberg T.
          Heart or lung transplanted patients' retrospective views on information and support while waiting for transplantation.
          as well as required self-care responsibilities after cardiothoracic transplantation/MCS implantation.
          • Davis L.A.
          • Ryszkiewicz E.
          • Schenk E.
          • et al.
          Lung transplant or bust: patients' recommendations for ideal lung transplant education.
          • Edlund J.E.
          • Edlund A.E.
          • Carey M.G.
          Patient understanding of potential risk and benefit with informed consent in a left ventricular assist device population: a pilot study.
          • Blumenthal-Barby J.S.
          • Kostick K.M.
          • Delgado E.D.
          • et al.
          Assessment of patients' and caregivers' informational and decisional needs for left ventricular assist device placement: implications for informed consent and shared decision-making.
          • David V.
          • Feldman D.
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