Methodology of a randomized clinical trial of symptom management strategies in patients receiving chronic hemodialysis: The SMILE study

Contemporary Clinical Trials

Volumn 31, Issue 5, 2010, Pages 491-497

  Weisbord, Steven D ^a,b   Shields, Anne Marie ^a   Mor, Maria K ^a,c   Sevick, Mary Ann ^a,b,c   Homer, Marcia ^a   Peternel, Janet ^a   Porter, Patricia ^a   Rollman, Bruce L ^b   Palevsky, Paul M ^a,b   Arnold, Robert M ^b   Fine, Michael J ^a,b  

^a VETERANS AFFAIRS MEDICAL CENTER   (United States)

^b UNIVERSITY OF PITTSBURGH SCHOOL OF MEDICINE   (United States)

^c UNIVERSITY OF PITTSBURGH GRADUATE SCHOOL OF PUBLIC HEALTH   (United States)

Author keywords

Depression; Erectile dysfunction; Hemodialysis; Pain; Sexual dysfunction; Symptoms

Indexed keywords

ADULT; ARTICLE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; DEPRESSION; DISEASE SEVERITY; EVIDENCE BASED PRACTICE; FEMALE; FEMALE SEXUAL FUNCTION INDEX; HEALTH CARE PERSONNEL; HEMODIALYSIS; HUMAN; INTERNATIONAL INDEX OF ERECTILE FUNCTION QUESTIONNAIRE; KIDNEY DISEASE; MALE; MCGILL PAIN QUESTIONNAIRE; MEDICAL DECISION MAKING; METHODOLOGY; MULTICENTER STUDY; NURSE TRAINING; OBSERVATIONAL STUDY; OUTPATIENT DEPARTMENT; PAIN; PATIENT HEALTH QUESTIONNAIRE 9; QUESTIONNAIRE; RANDOMIZED CONTROLLED TRIAL; SEXUAL DYSFUNCTION; SHORT FORM 12; SYMPTOM MANAGEMENT INVOLVING END STAGE RENAL DISEASE;

ALGORITHMS; CHRONIC DISEASE; DATA COLLECTION; DEPRESSION; FEMALE; HEMODIALYSIS UNITS, HOSPITAL; HUMANS; IMPOTENCE, VASCULOGENIC; KIDNEY FAILURE, CHRONIC; MALE; OUTPATIENTS; PAIN; PATIENT SATISFACTION; PSYCHOMETRICS; QUALITY OF LIFE; QUESTIONNAIRES; RANDOMIZED CONTROLLED TRIALS AS TOPIC; SEXUAL DYSFUNCTION, PHYSIOLOGICAL;

EID: 77957752030     PISSN: 15517144     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.cct.2010.06.005     Document Type: Article

References (42)

1. US Renal Data System: USRDS 2008 Annual Data Report. Bethesda, MD. The National Institutes of Health, National Institute of Diabetes and Digestive and Kidney Diseases.
2. Wanner C., Krane V., Marz W., et al. Atorvastatin in patients with type 2 diabetes mellitus undergoing hemodialysis. N Engl J Med 2005, 353:238-248.
3. Eknoyan G., Beck G.J., Cheung A.K., et al. Effect of dialysis dose and membrane flux in maintenance hemodialysis. N Engl J Med 2002, 347:2010-2019.
4. Evans R.W., Manninen D.L., Garrison L.P., et al. The quality of life of patients with end-stage renal disease. N Engl J Med 1985, 312:553-559.
5. Evans R.W., Rader B., Manninen D.L. The quality of life of hemodialysis recipients treated with recombinant human erythropoietin. Cooperative Multicenter EPO Clinical Trial Group. Jama 1990, 263:825-830.
6. Johnson J.P., McCauley C.R., Copley J.B. The quality of life of hemodialysis and transplant patients. Kidney Int 1982, 22:286-291.
7. Kimmel P.L. Just whose quality of life is it anyway? Controversies and consistencies in measurements of quality of life. Kidney International 2000, 57:S113-S120.
8. Kimmel P.L., Peterson R.A., Weihs K.L., et al. Aspects of quality of life in hemodialysis patients. J Am Soc Nephrol 1995, 6:1418-1426.
9. Davison S.N., Jhangri G.S., Johnson J.A. Longitudinal validation of a modified Edmonton symptom assessment system (ESAS) in haemodialysis patients. Nephrol Dial Transplant 2006, 21:3189-3195.
10. Merkus M.P., Jager K.J., Dekker F.W., de Haan R.J., Boeschoten E.W., Krediet R.T. Physical symptoms and quality of life in patients on chronic dialysis: results of The Netherlands Cooperative Study on Adequacy of Dialysis (NECOSAD). Nephrol Dial Transplant 1999, 14:1163-1170.
11. Parfrey P.S., Vavasour H., Bullock M., Henry S., Harnett J.D., Gault M.H. Symptoms in end-stage renal disease: dialysis v transplantation. Transplant Proc 1987, 19:3407-3409.
12. Weisbord S.D., Carmody S.S., Bruns F.J., et al. Symptom burden, quality of life, advance care planning and the potential value of palliative care in severely ill haemodialysis patients. Nephrol Dial Transplant 2003, 18:1345-1352.
13. Davison S.N. Pain in hemodialysis patients: prevalence, cause, severity, and management. Am J Kidney Dis 2003, 42:1239-1247.
14. Davison S.N., Jhangri G.S. The impact of chronic pain on depression, sleep, and the desire to withdraw from dialysis in hemodialysis patients. J Pain Symptom Manage 2005, 30:465-473.
15. Kimmel P.L. Psychosocial factors in dialysis patients. Kidney Int 2001, 59:1599-1613.
16. Kimmel P.L. Depression in patients with chronic renal disease: what we know and what we need to know. J Psychosom Res 2002, 53:951-956.
17. Kimmel P.L., Peterson R.A., Weihs K.L., et al. Multiple measurements of depression predict mortality in a longitudinal study of chronic hemodialysis outpatients. Kidney Int 2000, 57:2093-2098.
18. Rosas S.E., Joffe M., Franklin E., et al. Prevalence and determinants of erectile dysfunction in hemodialysis patients. Kidney Int 2001, 59:2259-2266.
19. Barakzoy A.S., Moss A.H. Efficacy of the world health organization analgesic ladder to treat pain in end-stage renal disease. J Am Soc Nephrol 2006, 17:3198-3203.
20. Seibel I., Poli De Figueiredo C.E., Teloken C., Moraes J.F. Efficacy of oral sildenafil in hemodialysis patients with erectile dysfunction. J Am Soc Nephrol 2002, 13:2770-2775.
21. Carreon M., Fried L.F., Palevsky P.M., Kimmel P.L., Arnold R.M., Weisbord S.D. Clinical correlates and treatment of bone/joint pain and difficulty with sexual arousal in patients on maintenance hemodialysis. Hemodial Int 2008, 12:268-274.
22. Hedayati S.S., Bosworth H.B., Briley L.P., et al. Death or hospitalization of patients on chronic hemodialysis is associated with a physician-based diagnosis of depression. Kidney Int 2008, 74:930-936.
23. Hedayati S.S., Bosworth H.B., Kuchibhatla M., Kimmel P.L., Szczech L.A. The predictive value of self-report scales compared with physician diagnosis of depression in hemodialysis patients. Kidney Int 2006.
24. Kimmel P.L., Peterson R.A. Depression in end-stage renal disease patients treated with hemodialysis: tools, correlates, outcomes, and needs. Semin Dial 2005, 18:91-97.
25. Kimmel P.L., Thamer M., Richard C.M., Ray N.F. Psychiatric illness in patients with end-stage renal disease. Am J Med 1998, 105:214-221.
26. Levy N.B., Blumenfield M., Beasley C.M., et al. Fluoxetine in depressed patients with renal failure and in depressed patients with normal kidney function. Gen Hosp Psychiatry 1996, 18:8-13.
27. Blumenfield M., Levy N.B., Spinowitz B., et al. Fluoxetine in depressed patients on dialysis. Int J Psychiatry Med 1997, 27:71-80.
28. Weisbord S.D., Fried L.F., Mor M.K., Resnick A.L., Unruh M.L., Palevsky P.M., et al. Renal provider recognition of symptoms in patients on maintenance hemodialysis. Clin J Am Soc Nephrol 2007, 2:960-967.
29. Borson S., Scanlan J.M., Chen P., Ganguli M. The Mini-Cog as a screen for dementia: validation in a population-based sample. J Am Geriatr Soc 2003, 51:1451-1454.
30. Borson S., Scanlan J.M., Watanabe J., Tu S.P., Lessig M. Simplifying detection of cognitive impairment: comparison of the Mini-Cog and Mini-Mental State Examination in a multiethnic sample. J Am Geriatr Soc 2005, 53:871-874.
31. Davis T.C., Long S.W., Jackson R.H., Mayeaux E.J., George R.B., Murphy P.W., et al. Rapid estimate of adult literacy in medicine: a shortened screening instrument. Fam Med 1993, 25:391-395.
32. Kleinpeter M.A. Health literacy affects peritoneal dialysis performance and outcomes. Adv Perit Dial 2003, 19:115-119.
33. Melzack R. The short-form McGill Pain Questionnaire. Pain 1987, 30:191-197.
34. Rosen R., Brown C., Heiman J., Leiblum S., Meston C., Shabsigh R., et al. The Female Sexual Function Index (FSFI): a multidimensional self-report instrument for the assessment of female sexual function. J Sex Marital Ther 2000, 26:191-208.
35. Rosen R.C., Cappelleri J.C., Smith M.D., Lipsky J., Pena B.M. Development and evaluation of an abridged, 5-item version of the International Index of Erectile Function (IIEF-5) as a diagnostic tool for erectile dysfunction. Int J Impot Res 1999, 11:319-326.
36. Watnick S., Wang P.L., Demadura T., Ganzini L. Validation of 2 depression screening tools in dialysis patients. Am J Kidney Dis 2005, 46:919-924.
37. Seethala S., Hess R., Bossola M., Unruh M.L., Weisboard S.D. Sexual function in women receiving maintenance dialysis. Hemodial Int 2010, 14:55-60.
38. Cafazzo J.A., Leonard K., Easty A.C., Rossos P.G., Chan C.T. Patient-perceived barriers to the adoption of nocturnal home hemodialysis. Clin J Am Soc Nephrol 2009, 4:784-789.
39. Neri L., Rocca Rey L.A., Gallieni M., Brancaccio D., Cozzolino M., Colombi A., et al. Occupational stress is associated with impaired work ability and reduced quality of life in patients with chronic kidney failure. Int J Artif Organs 2009, 32:291-298.
40. Weisbord S.D., Fried L.F., Arnold R.M., Fine M.J., Levenson D.J., Peterson R.A., et al. Prevalence, severity, and importance of physical and emotional symptoms in chronic hemodialysis patients. J Am Soc Nephrol 2005, 16:2487-2494.
41. Weisbord S.D., Fried L.F., Arnold R.M., Rotondi A.J., Fine M.J., Levenson D.J., et al. Development of a symptom assessment instrument for chronic hemodialysis patients: the Dialysis Symptom Index. J Pain Symptom Manage 2004, 27:226-240.
42. Rubin H.R., Fink N.E., Plantinga L.C., Sadler J.H., Kliger A.S., Powe N.R. Patient ratings of dialysis care with peritoneal dialysis vs hemodialysis. Jama 2004, 291:697-703.