Akman B, Uyar M, Afsar B, Sezer S, Ozdemir FN, Haberal M Adherence, depression and quality of life in patients on a renal transplantation waiting list. Transpl Int. 2007 Aug;20(8):682-7. doi: 10.1111/j.1432-2277.2007.00495.x. Epub 2007 May 29.
Bandura A Self-efficacy: toward a unifying theory of behavioral change. Psychol Rev. 1977 Mar;84(2):191-215. doi: 10.1037//0033-295x.84.2.191. No abstract available.
Bansal, A , et al., Accuracy of the PROMIS-57 Depression and Anxiety Scales in Kidney Transplant Recipients, in CST-CNTRP-SQT Joint Scientific Meeting. 2017: Halifax, NS, Canada.
Baranyi A, Krauseneck T, Rothenhausler HB Overall mental distress and health-related quality of life after solid-organ transplantation: results from a retrospective follow-up study. Health Qual Life Outcomes. 2013 Feb 8;11:15. doi: 10.1186/1477-7525-11-15.
Barrett, T A., Outpatient Cardiac Palliative Care Reduces Healthcare Utilization. The Journal of Heart and Lung Transplantation, 2020. 39(4, Supplement): p. S362.
Basch E Patient-Reported Outcomes - Harnessing Patients' Voices to Improve Clinical Care. N Engl J Med. 2017 Jan 12;376(2):105-108. doi: 10.1056/NEJMp1611252. No abstract available.
Baumann AJ, Wheeler DS, James M, Turner R, Siegel A, Navarro VJ Benefit of Early Palliative Care Intervention in End-Stage Liver Disease Patients Awaiting Liver Transplantation. J Pain Symptom Manage. 2015 Dec;50(6):882-6.e2. doi: 10.1016/j.jpainsymman.2015.07.014. Epub 2015 Aug 22.
Blevins CA, Weathers FW, Davis MT, Witte TK, Domino JL The Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5): Development and Initial Psychometric Evaluation. J Trauma Stress. 2015 Dec;28(6):489-98. doi: 10.1002/jts.22059. Epub 2015 Nov 25.
Bryant RA, Creamer M, O'Donnell M, Silove D, McFarlane AC The capacity of acute stress disorder to predict posttraumatic psychiatric disorders. J Psychiatr Res. 2012 Feb;46(2):168-73. doi: 10.1016/j.jpsychires.2011.10.007. Epub 2011 Nov 14.
Butler LD, Koopman C, Classen C, Spiegel D Traumatic stress, life events, and emotional support in women with metastatic breast cancer: cancer-related traumatic stress symptoms associated with past and current stressors. Health Psychol. 1999 Nov;18(6):555-60. doi: 10.1037//0278-6133.18.6.555.
Cardena E, Koopman C, Classen C, Waelde LC, Spiegel D Psychometric properties of the Stanford Acute Stress Reaction Questionnaire (SASRQ): a valid and reliable measure of acute stress. J Trauma Stress. 2000 Oct;13(4):719-34. doi: 10.1023/A:1007822603186.
Chisholm-Burns MA, Spivey CA, Wilks SE Social support and immunosuppressant therapy adherence among adult renal transplant recipients. Clin Transplant. 2010 May-Jun;24(3):312-20. doi: 10.1111/j.1399-0012.2009.01060.x. Epub 2009 Aug 19.
Dano S, Pokarowski M, Liao B, Tang E, Ekundayo O, Li V, Edwards N, Ford H, Novak M, Mucsi I Evaluating symptom burden in kidney transplant recipients: validation of the revised Edmonton Symptom Assessment System for kidney transplant recipients - a single-center, cross-sectional study. Transpl Int. 2020 Apr;33(4):423-436. doi: 10.1111/tri.13572. Epub 2020 Jan 30.
Davison SN, Jassal SV Supportive Care: Integration of Patient-Centered Kidney Care to Manage Symptoms and Geriatric Syndromes. Clin J Am Soc Nephrol. 2016 Oct 7;11(10):1882-1891. doi: 10.2215/CJN.01050116. Epub 2016 Aug 10.
Davison SN, Rathwell S, Ghosh S, George C, Pfister T, Dennett L The Prevalence and Severity of Chronic Pain in Patients With Chronic Kidney Disease: A Systematic Review and Meta-Analysis. Can J Kidney Health Dis. 2021 Feb 19;8:2054358121993995. doi: 10.1177/2054358121993995. eCollection 2021.
Davison SN Patient-Oriented Research: Clinical Innovation Based on CKD Patients' Priorities for Care. Am J Kidney Dis. 2016 Dec;68(6):833-835. doi: 10.1053/j.ajkd.2016.09.004. No abstract available.
Di Maio M, Basch E, Bryce J, Perrone F Patient-reported outcomes in the evaluation of toxicity of anticancer treatments. Nat Rev Clin Oncol. 2016 May;13(5):319-25. doi: 10.1038/nrclinonc.2015.222. Epub 2016 Jan 20.
Engel GL The need for a new medical model: a challenge for biomedicine. Science. 1977 Apr 8;196(4286):129-36. doi: 10.1126/science.847460.
Epstein AS, Goldberg GR, Meier DE Palliative care and hematologic oncology: the promise of collaboration. Blood Rev. 2012 Nov;26(6):233-9. doi: 10.1016/j.blre.2012.07.001. Epub 2012 Aug 5.
Freeman N, Le LW, Singer LG, Colman R, Zimmermann C, Wentlandt K Impact of a transplant palliative care clinic on symptoms for patients awaiting lung transplantation. J Heart Lung Transplant. 2016 Aug;35(8):1037-9. doi: 10.1016/j.healun.2016.05.006. Epub 2016 May 16. No abstract available.
Fries JF, Cella D, Rose M, Krishnan E, Bruce B Progress in assessing physical function in arthritis: PROMIS short forms and computerized adaptive testing. J Rheumatol. 2009 Sep;36(9):2061-6. doi: 10.3899/jrheum.090358.
Hays RD, Bjorner JB, Revicki DA, Spritzer KL, Cella D Development of physical and mental health summary scores from the patient-reported outcomes measurement information system (PROMIS) global items. Qual Life Res. 2009 Sep;18(7):873-80. doi: 10.1007/s11136-009-9496-9. Epub 2009 Jun 19.
Hays RD, Spritzer KL, Schalet BD, Cella D PROMIS(R)-29 v2.0 profile physical and mental health summary scores. Qual Life Res. 2018 Jul;27(7):1885-1891. doi: 10.1007/s11136-018-1842-3. Epub 2018 Mar 22.
Jin S, Xiang B, Zhong L, Yan L, Chen Z, Wang W, Xu M, Yang J Quality of life and psychological distress of adult recipients after living donor liver transplantation. Transplant Proc. 2013 Jan-Feb;45(1):281-5. doi: 10.1016/j.transproceed.2012.05.076.
Joshi VD Quality of life in end stage renal disease patients. World J Nephrol. 2014 Nov 6;3(4):308-16. doi: 10.5527/wjn.v3.i4.308.
Koopman C, Gore-Felton C, Classen C, Kim P, Spiegel D Acute stress reactions to everyday stressful life events among sexual abuse survivors with PTSD. J Child Sex Abus. 2001;10(2):83-99. doi: 10.1300/j070v10n02_05.
Kovacs AZ, Molnar MZ, Szeifert L, Ambrus C, Molnar-Varga M, Szentkiralyi A, Mucsi I, Novak M Sleep disorders, depressive symptoms and health-related quality of life--a cross-sectional comparison between kidney transplant recipients and waitlisted patients on maintenance dialysis. Nephrol Dial Transplant. 2011 Mar;26(3):1058-65. doi: 10.1093/ndt/gfq476. Epub 2010 Aug 4.
Kwok, M , et al., Psychosocial distress and health related quality of life in kidney transplant recipients, in CST-CNTRP-SQT Joint Scientific Meeting 2017: Halifax, NS, Canada.
Lee RT, Ramchandran K, Sanft T, Von Roenn J Implementation of supportive care and best supportive care interventions in clinical trials enrolling patients with cancerdagger. Ann Oncol. 2015 Sep;26(9):1838-1845. doi: 10.1093/annonc/mdv207. Epub 2015 Apr 28.
Morales JM, Varo E, Lazaro P Immunosuppressant treatment adherence, barriers to adherence and quality of life in renal and liver transplant recipients in Spain. Clin Transplant. 2012 Mar-Apr;26(2):369-76. doi: 10.1111/j.1399-0012.2011.01544.x. Epub 2011 Oct 30.
Ontario, C C., Symptom Management Guides to Practice. Website accessed October 11, 2020.
Papuga MO, Dasilva C, McIntyre A, Mitten D, Kates S, Baumhauer JF Large-scale clinical implementation of PROMIS computer adaptive testing with direct incorporation into the electronic medical record. Health Syst (Basingstoke). 2017 Dec 7;7(1):1-12. doi: 10.1057/s41306-016-0016-1. eCollection 2018.
Pelgur H, Atak N, Kose K Anxiety and depression levels of patients undergoing liver transplantation and their need for training. Transplant Proc. 2009 Jun;41(5):1743-8. doi: 10.1016/j.transproceed.2008.11.012.
Penkower L, Dew MA, Ellis D, Sereika SM, Kitutu JM, Shapiro R Psychological distress and adherence to the medical regimen among adolescent renal transplant recipients. Am J Transplant. 2003 Nov;3(11):1418-25. doi: 10.1046/j.1600-6135.2003.00226.x.
Perepletchikova, F and A.E. Kazdin, Treatment Integrity and Therapeutic Change: Issues and Research Recommendations. Clinical Psychology: Science and Practice, 2005. 12(4): p. 365-383.
Pullen LC Bringing palliative care to transplant. Am J Transplant. 2021 Jul;21(7):2315-2316. doi: 10.1111/ajt.16035. No abstract available.
Report, T -H.T., We ask because we care- The Tri-Hospital + TPH Health Equity Data Collection Research Project Report. 2013: p. 51.
Rodin G, An E, Shnall J, Malfitano C Psychological Interventions for Patients With Advanced Disease: Implications for Oncology and Palliative Care. J Clin Oncol. 2020 Mar 20;38(9):885-904. doi: 10.1200/JCO.19.00058. Epub 2020 Feb 5.
Rodin, G and L.A. Gillies, Individual Psychotherapy for the Patient with Advanced Disease, in Handbook of Psychiatry in Palliative Medicine, W.B. Harvey Max Chochinov, Editor. 2009, Oxford University Press: New York. p. 189-196.
Rodrigue JR, Nelson DR, Hanto DW, Reed AI, Curry MP Patient-reported immunosuppression nonadherence 6 to 24 months after liver transplant: association with pretransplant psychosocial factors and perceptions of health status change. Prog Transplant. 2013 Dec;23(4):319-28. doi: 10.7182/pit2013501.
Segawa E, Schalet B, Cella D A comparison of computer adaptive tests (CATs) and short forms in terms of accuracy and number of items administrated using PROMIS profile. Qual Life Res. 2020 Jan;29(1):213-221. doi: 10.1007/s11136-019-02312-8. Epub 2019 Oct 8.
Sim J, Lewis M The size of a pilot study for a clinical trial should be calculated in relation to considerations of precision and efficiency. J Clin Epidemiol. 2012 Mar;65(3):301-8. doi: 10.1016/j.jclinepi.2011.07.011. Epub 2011 Dec 9.
Smith AB, Hanbury A, Retzler J Item banking and computer-adaptive testing in clinical trials: Standing in sight of the PROMISed land. Contemp Clin Trials Commun. 2018 Nov 17;13:005-5. doi: 10.1016/j.conctc.2018.11.005. eCollection 2019 Mar.
Spiegel, D and P. Spira, Supportive-Expressive Group Therapy: A Treatment Manual of Psychosocial Intervention for Women with Recurrent Breast Cancer. 1991, Stanford, CA: Psychosocial Treatment Laboratory, Stanford University School of Medicine.
Stover AM, Basch EM Using patient-reported outcome measures as quality indicators in routine cancer care. Cancer. 2016 Feb 1;122(3):355-7. doi: 10.1002/cncr.29768. Epub 2015 Nov 30. No abstract available.
Tang E, Bansal A, Novak M, Mucsi I Patient-Reported Outcomes in Patients with Chronic Kidney Disease and Kidney Transplant-Part 1. Front Med (Lausanne). 2018 Jan 15;4:254. doi: 10.3389/fmed.2017.00254. eCollection 2017.
Tang, E , et al. Validation of the PROMIS-57 and PROMIS-29 short form profile questionnaires in patients undergoing Hemodialysis. in Annual General Meeting of the Canadian Society of Nephrology. 2018. Vancouver, BC.
Whitehead AL, Julious SA, Cooper CL, Campbell MJ Estimating the sample size for a pilot randomised trial to minimise the overall trial sample size for the external pilot and main trial for a continuous outcome variable. Stat Methods Med Res. 2016 Jun;25(3):1057-73. doi: 10.1177/0962280215588241. Epub 2015 Jun 19.
Wiebe C, Nevins TE, Robiner WN, Thomas W, Matas AJ, Nickerson PW The Synergistic Effect of Class II HLA Epitope-Mismatch and Nonadherence on Acute Rejection and Graft Survival. Am J Transplant. 2015 Aug;15(8):2197-202. doi: 10.1111/ajt.13341. Epub 2015 Jun 11.
Emotion And Symptom-focused Engagement (EASE) Intervention for the Management of Emotional and Physical Symptoms Among Solid Organ Transplant Recipients-pilot Study
Interventional studies are often prospective and are specifically tailored to evaluate direct impacts of treatment or preventive measures on disease.
Observational studies are often retrospective and are used to assess potential causation in exposure-outcome relationships and therefore influence preventive methods.
Expanded access is a means by which manufacturers make investigational new drugs available, under certain circumstances, to treat a patient(s) with a serious disease or condition who cannot participate in a controlled clinical trial.
Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.
Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.