Background: End-stage renal disease patients experience significant impairments in health-related quality of life (HRQOL). Testing various strategies to improve patient HRQOL in multicenter clinical trials, such as the Frequent Hemodialysis Network (FHN) trials is vitally important. Aims: Theaim of this paper is to describe the design and conduct of HRQOL and patient-reported outcomes (PRO) assessment in the FHN trials. Methods: In the FHN trials, HRQOL was examined as a multidimensional concept, and the SF-36 RAND Physical Health Composite score was one of the co-primary outcomes. The instruments completed to assess HRQOL included the Medical Outcomes Study Short Form SF-36, Health Utilities Index 3, Sleep Problems Index, Beck Depression Inventory and feeling thermometer. These instruments have been shown to have high reliability, validity and responsiveness to change in the end-stage renal disease population. Additional items evaluating PRO including sexual function, time to recovery after dialysis and patients’ self-perceived burden to caregiver were also assessed. All questionnaires were administered by trained interviewers using computer-assisted telephone interviewing to ensure blinding and minimizing selection bias. Interim analysis reveals that these instruments can be used to collect a comprehensive set of HRQOL measures with minimal patient burden. Conclusions: Accurate measurement of HRQOL and PRO can help us test whether hemodialysis interventions improve the health and well-being of this compromised patient population. We have shown that a comprehensive set of HRQOL measures can be centrally collected through telephone interviews in a blinded fashion, in a way that is well tolerated with minimum respondent burden.

Keywords:
Health-related quality of life, Frequent Hemodialysis Network, End-stage renal disease
1.
Merkus MP, et al: 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.
2.
Parfrey PS, et al: Clinical features and severity of nonspecific symptoms in dialysis patients. Nephron 1988;50:121–128.
3.
Jhamb M, et al: Fatigue in patients receiving maintenance dialysis: a review of definitions, measures, and contributing factors. Am J Kidney Dis 2008;52:353–365.
4.
Weisbord SD, et al: Prevalence, severity, and importance of physical and emotional symptoms in chronic hemodialysis patients. J Am Soc Nephrol 2005;16:2487–2494.
5.
Agganis BT, et al: Depression and cognitive function in maintenance hemodialysis patients. Am J Kidney Dis 2010;56:704–712.
6.
Park HC, et al: Depression and health-related quality of life in maintenance hemodialysis patients. Clin Nephrol 2010;73:374–380.
7.
Unruh ML, et al: Sleep quality and clinical correlates in patients on maintenance dialysis. Clin Nephrol 2003;59:280–288.
8.
Kimmel PL, Cohen SD, Weisbord SD: Quality of life in patients with end-stage renal disease treated with hemodialysis: survival is not enough! J Nephrol 2008;21(suppl 13):S54–S58.
9.
Ramkumar N, et al: Patient preferences for in-center intense hemodialysis. Hemodial Int 2005;9:281–295.
10.
DeOreo PB: Hemodialysis patient-assessed functional health status predicts continued survival, hospitalization, and dialysis-attendance compliance. Am J Kidney Dis 1997;30:204–212.
11.
Lowrie EG, et al: Medical outcomes study short form-36: a consistent and powerful predictor of morbidity and mortality in dialysis patients. Am J Kidney Dis 2003;41:1286–1292.
12.
Mapes DL, et al: Health-related quality of life as a predictor of mortality and hospitalization: the Dialysis Outcomes and Practice Patterns Study (DOPPS). Kidney Int 2003;64:339–349.
13.
DeOreo PB: The use of patient-based instruments to measure, manage, and improve quality of care in dialysis facilities. Adv Ren Replace Ther 2001;8:125–130.
14.
Meyer KB, et al: Monitoring dialysis patients’ health status. Am J Kidney Dis 1994;24:267–279.
15.
Kimmel PL, et al: Aspects of quality of life in hemodialysis patients. J Am Soc Nephrol 1995;6:1418–1426.
16.
Suri RS, et al: Frequent Hemodialysis Network (FHN) randomized trials: study design. Kidney Int 2007;71:349–359.
17.
Unruh M, et al: Effects of hemodialysis dose and membrane flux on health-related quality of life in the HEMO Study. Kidney Int 2004;66:355–366.
18.
Bayliss G, Danziger J: Nocturnal versus conventional haemodialysis: some current issues. Nephrol Dial Transplant 2009;24:3612–3617.
19.
Suri RS, et al: Daily hemodialysis: a systematic review. Clin J Am Soc Nephrol 2006;1:33–42.
20.
Walsh M, et al: A systematic review of the effect of nocturnal hemodialysis on blood pressure, left ventricular hypertrophy, anemia, mineral metabolism, and health-related quality of life. Kidney Int 2005;67:1500–1508.
21.
Lockridge RS Jr: Daily dialysis and long-term outcomes – the Lynchburg Nephrology NHHD experience. Nephrol News Issues 1999;13:16, 19, 23–26.
22.
McPhatter LL, et al: Nightly home hemodialysis: improvement in nutrition and quality of life. Adv Ren Replace Ther 1999;6:358–365.
23.
Fong E, Bargman JM, Chan CT: Cross-sectional comparison of quality of life and illness intrusiveness in patients who are treated with nocturnal home hemodialysis versus peritoneal dialysis. Clin J Am Soc Nephrol 2007;2:1195–1200.
24.
Manns BJ, et al: Nocturnal hemodialysis does not improve overall measures of quality of life compared to conventional hemodialysis. Kidney Int 2009;75:542–549.
25.
Heidenheim AP, et al: Patient quality of life on quotidian hemodialysis. Am J Kidney Dis 2003;42(suppl 1):36–41.
26.
Jaber BL, et al: Effect of daily hemodialysis on depressive symptoms and postdialysis recovery time: interim report from the FREEDOM (Following Rehabilitation, Economics and Everyday-Dialysis Outcome Measurements) Study. Am J Kidney Dis 2010;56:531–539.
27.
Kalantar-Zadeh K, Unruh M: Health related quality of life in patients with chronic kidney disease. Int Urol Nephrol 2005;37:367–378.
28.
Unruh ML, Weisbord SD, Kimmel PL: Health-related quality of life in nephrology research and clinical practice. Semin Dial 2005;18:82–90.
29.
Ware J, Keller S: Quality of Life and Pharmacoeconomics in Clinical Trials, ed 2. Interpreting General Health Measures, 1996, pp 445–460.
30.
Ware J, et al: SF-36 Health Survey Manual and Interpretation Guide. Boston, The Health Institute, 1993.
31.
Bergner M, et al: The Sickness Impact Profile: development and final revision of a health status measure. Med Care 1981;19:787–805.
32.
Campbell A, Converse P, Rogers W: The Quality of American Life: Perceptions, Evaluations and Satisfactions. New York, Russell Sage Foundation, 1976.
33.
Hornberger JC, Redelmeier DA, Petersen J: Variability among methods to assess patients’ well-being and consequent effect on a cost-effectiveness analysis. J Clin Epidemiol 1992;45:505–512.
34.
Hunt S, McEwan J, McKenna SP: Measuring Health Status. London, Croom Helm, 1986.
35.
Bergner M: Development, testing and use of the Sickness Impact Profile Quality of Life Assessment: Key Issues in the 1990s. Dordrecht, Kluwer Academic Publishers, 1993.
36.
Edgell ET, et al: A review of health-related quality-of-life measures used in end-stage renal disease. Clin Ther 1996;18:887–938.
37.
Cagney KA, et al: Formal literature review of quality-of-life instruments used in end-stage renal disease. Am J Kidney Dis 2000;36:327–336.
38.
Kurtin PS, et al: Patient-based health status measures in outpatient dialysis. Early experiences in developing an outcomes assessment program. Med Care 1992;30(suppl): MS136–MS149.
39.
Rettig RA, Sadler JH: Measuring and improving the health status of end stage renal disease patients. Health Care Financ Rev 1997;18:77–82.
40.
Beusterien KM, et al: The effects of recombinant human erythropoietin on functional health and well-being in chronic dialysis patients. J Am Soc Nephrol 1996;7:763–773.
41.
Nortvedt MW, et al: Performance of the SF-36, SF-12, and RAND-36 summary scales in a multiple sclerosis population. Med Care 2000;38:1022–1028.
42.
Churchill DN, et al: Measurement of quality of life in end-stage renal disease: the time trade-off approach. Clin Invest Med 1987;10:14–20.
43.
Laupacis A, Wong C, Churchill D: The use of generic and specific quality-of-life measures in hemodialysis patients treated with erythropoietin. The Canadian Erythropoietin Study Group. Control Clin Trials 1991;12(suppl):168S–179S.
44.
Liem YS, Bosch JL, Hunink MG: Preference-based quality of life of patients on renal replacement therapy: a systematic review and meta-analysis. Value Health 2008;11:733–741.
45.
Torrance GW: Preferences for health outcomes and cost-utility analysis. Am J Manag Care 1997;(suppl):S8–S20.
46.
Horsman J, et al: The Health Utilities Index (HUI): concepts, measurement properties and applications. Health Qual Life Outcomes 2003;1:54.
47.
Baldassarre FG, et al: Effect of coronary artery bypass graft surgery on older women’s health-related quality of life. Heart Lung 2002;31:421–431.
48.
Schunemann HJ, et al: Evaluation of the minimal important difference for the feeling thermometer and the St. George’s Respiratory Questionnaire in patients with chronic airflow obstruction. J Clin Epidemiol 2003;56:1170–1176.
49.
Cohen SD, et al: Screening, diagnosis, and treatment of depression in patients with end-stage renal disease. Clin J Am Soc Nephrol 2007;2:1332–1342.
50.
Hedayati SS, Finkelstein FO: Epidemiology, diagnosis, and management of depression in patients with CKD. Am J Kidney Dis 2009;54:741–752.
51.
Shidler NR, Peterson RA, Kimmel PL: Quality of life and psychosocial relationships in patients with chronic renal insufficiency. Am J Kidney Dis 1998;32:557–566.
52.
Kimmel PL: Psychosocial factors in adult end-stage renal disease patients treated with hemodialysis: correlates and outcomes. Am J Kidney Dis 2000;35(suppl 1):S132–S140.
53.
Kimmel PL, et al: Psychiatric illness in patients with end-stage renal disease. Am J Med 1998;105:214–221.
54.
Moul DE, et al: Self-report measures of insomnia in adults: rationales, choices, and needs. Sleep Med Rev 2004;8:177–198.
55.
Johns MW: A new method for measuring daytime sleepiness: the Epworth sleepiness scale. Sleep 1991;14:540–545.
56.
Buysse DJ, et al: The Pittsburgh Sleep Quality Index: a new instrument for psychiatric practice and research. Psychiatry Res 1989;28:193–213.
57.
King AC, et al: Moderate-intensity exercise and self-rated quality of sleep in older adults. A randomized controlled trial. JAMA 1997;277:32–37.
58.
Carpenter JS, Andrykowski MA: Psychometric evaluation of the Pittsburgh Sleep Quality Index. J Psychosom Res 1998;45:5–13.
59.
Iliescu EA, et al: Quality of sleep and health-related quality of life in haemodialysis patients. Nephrol Dial Transplant 2003;18:126–132.
60.
Cousineau N, et al: Measuring chronic patients’ feelings of being a burden to their caregivers: development and preliminary validation of a scale. Med Care 2003;41:110–118.
61.
Lindsay RM, et al: Minutes to recovery after a hemodialysis session: a simple health-related quality of life question that is reliable, valid, and sensitive to change. Clin J Am Soc Nephrol 2006;1:952–959.
62.
Chang TI, Winkelmayer WC: Kidney disease and antihypertensive medication adherence: the need for improved measurement tools. Am J Kidney Dis 2010;56:423–426.
63.
Hansen RA, et al: Comparison of methods to assess medication adherence and classify nonadherence. Ann Pharmacother 2009;43:413–422.
64.
Unruh M, et al: Bias in assessment of health-related quality of life in a hemodialysis population: a comparison of self-administered and interviewer-administered surveys in the HEMO study. J Am Soc Nephrol 2003;14:2132–2141.
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2011
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