Patients receiving frequent hemodialysis have better health-related quality of life compared to patients receiving conventional hemodialysis

Most patients with end-stage kidney disease value their health-related quality of life (HRQoL) and want to know how it will be affected by their dialysis modality. We extended the findings of two prior clinical trial reports to estimate the effects of frequent compared to conventional hemodialysis on additional measures of HRQoL. The Daily Trial randomly assigned 245 patients to receive frequent (six times per week) or conventional (three times per week) in-center hemodialysis. The Nocturnal Trial randomly assigned 87 patients to receive frequent nocturnal (six times per week) or conventional (three times per week) home hemodialysis. All patients were on conventional hemodialysis prior to randomization, with an average feeling thermometer score of 70 to 75 (a visual analog scale from 0 to 100 where 100 is perfect health), an average general health scale score of 40 to 47 (a score from 0 to 100 where 100 is perfect health), and an average dialysis session recovery time of 2 to 3 hours. Outcomes are reported as the between-treatment group differences in one-year change in HRQoL measures and analyzed using linear mixed effects models. After one year in the Daily Trial, patients assigned to frequent in-center hemodialysis reported a higher feeling thermometer score, better general health, and a shorter recovery time after a dialysis session compared to standard thrice-weekly dialysis. After one year in the Nocturnal Trial, patients assigned to frequent home hemodialysis also reported a shorter recovery time after a dialysis session, but no statistical difference in their feeling thermometer or general health scores compared to standard home dialysis schedules. Thus, patients receiving day or nocturnal hemodialysis on average recovered approximately one hour earlier from a frequent compared to conventional hemodialysis session. Patients treated in an in-center dialysis facility reported better HRQoL with frequent compared to conventional hemodialysis. Most patients with end-stage kidney disease value their health-related quality of life (HRQoL) and want to know how it will be affected by their dialysis modality. We extended the findings of two prior clinical trial reports to estimate the effects of frequent compared to conventional hemodialysis on additional measures of HRQoL. The Daily Trial randomly assigned 245 patients to receive frequent (six times per week) or conventional (three times per week) in-center hemodialysis. The Nocturnal Trial randomly assigned 87 patients to receive frequent nocturnal (six times per week) or conventional (three times per week) home hemodialysis. All patients were on conventional hemodialysis prior to randomization, with an average feeling thermometer score of 70 to 75 (a visual analog scale from 0 to 100 where 100 is perfect health), an average general health scale score of 40 to 47 (a score from 0 to 100 where 100 is perfect health), and an average dialysis session recovery time of 2 to 3 hours. Outcomes are reported as the between-treatment group differences in one-year change in HRQoL measures and analyzed using linear mixed effects models. After one year in the Daily Trial, patients assigned to frequent in-center hemodialysis reported a higher feeling thermometer score, better general health, and a shorter recovery time after a dialysis session compared to standard thrice-weekly dialysis. After one year in the Nocturnal Trial, patients assigned to frequent home hemodialysis also reported a shorter recovery time after a dialysis session, but no statistical difference in their feeling thermometer or general health scores compared to standard home dialysis schedules. Thus, patients receiving day or nocturnal hemodialysis on average recovered approximately one hour earlier from a frequent compared to conventional hemodialysis session. Patients treated in an in-center dialysis facility reported better HRQoL with frequent compared to conventional hemodialysis. There is a growing effort to make health care and health policies more patient-centered. This requires greater knowledge of how a treatment affects patient-reported outcomes, where information comes directly from a patient without interpretation of their treatment response by a clinician.1Anker S.D. Agewall S. Borggrefe M. et al.The importance of patient-reported outcomes: a call for their comprehensive integration in cardiovascular clinical trials.Eur Heart J. 2014; 35: 2001-2009Crossref PubMed Scopus (219) Google Scholar Most patients with end-stage kidney disease place enormous value on their health-related quality of life (HRQoL), even over survival, and want to know how their HRQoL will be affected by their choice of dialysis modality.2Ramkumar N. Beddhu S. Eggers P. et al.Patient preferences for in-center intense hemodialysis.Hemodial Int. 2005; 9: 281-295Crossref PubMed Scopus (64) Google Scholar More than 2 million people worldwide receive conventional hemodialysis 3 sessions per week to sustain life.3Jain A.K. Blake P. Cordy P. Garg A.X. Global trends in rates of peritoneal dialysis.J Am Soc Nephrol. 2012; 23: 533-544Crossref PubMed Scopus (377) Google Scholar More frequent hemodialysis (5 or 6 sessions per week) results in greater weekly solute and fluid removal, and may be associated with better HRQoL (as observed in small studies4Walsh M. Culleton B. Tonelli M. Manns B. 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: 1500-1508Abstract Full Text Full Text PDF PubMed Scopus (189) Google Scholar, 5Suri R.S. Nesrallah G.E. Mainra R. et al.Daily hemodialysis: a systematic review.Clin J Am Soc Nephrol. 2006; 1: 33-42Crossref PubMed Scopus (169) Google Scholar). We previously reported the primary results of 2 parallel 12-month follow-up randomized controlled trials of frequent hemodialysis (Frequent Hemodialysis Network [FHN] Daily and Nocturnal Trials).6Chertow G.M. Levin N.W. Beck G.J. et al.In-center hemodialysis six times per week versus three times per week.N Engl J Med. 2010; 363: 2287-2300Crossref PubMed Scopus (823) Google Scholar, 7Rocco M.V. Lockridge Jr., R.S. Beck G.J. et al.The effects of frequent nocturnal home hemodialysis: the Frequent Hemodialysis Network Nocturnal Trial.Kidney Int. 2011; 80: 1080-1091Abstract Full Text Full Text PDF PubMed Scopus (403) Google Scholar One of 2 coprimary outcomes reported in the primary results of these trials was the baseline to 12-month change in a commonly used patient-reported physical health survey score (the Physical Health Composite from the RAND Short-Form 36-item survey8Suri R.S. Garg A.X. Chertow G.M. et al.Frequent Hemodialysis Network (FHN) randomized trials: study design.Kidney Int. 2007; 71: 349-359Abstract Full Text Full Text PDF PubMed Scopus (192) Google Scholar). After 1 year in the Daily Trial, patients assigned to frequent versus conventional in-center hemodialysis reported a better score.6Chertow G.M. Levin N.W. Beck G.J. et al.In-center hemodialysis six times per week versus three times per week.N Engl J Med. 2010; 363: 2287-2300Crossref PubMed Scopus (823) Google Scholar After 1 year in the Nocturnal Trial, we could not reliably determine whether patients assigned to frequent nocturnal versus conventional hemodialysis truly differed in this score, as the trial did not meet its recruitment target, resulting in estimates with wide confidence intervals.7Rocco M.V. Lockridge Jr., R.S. Beck G.J. et al.The effects of frequent nocturnal home hemodialysis: the Frequent Hemodialysis Network Nocturnal Trial.Kidney Int. 2011; 80: 1080-1091Abstract Full Text Full Text PDF PubMed Scopus (403) Google Scholar Several additional patient-reported measures of general well-being were collected in the FHN trials to better assess the multidimensional concept of HRQoL. These measures have not been reported elsewhere. In this article, we investigated whether frequent hemodialysis compared with conventional hemodialysis affects 4 measures of HRQoL collected in the 2 FHN trials. Patient selection from both trials is presented in Figure 1a and 1b . Baseline characteristics of patients in each trial are summarized in Tables 1 and 2. As confirmed in previous reports, the baseline characteristics of patients assigned to frequent versus conventional hemodialysis were similar in each trial.Figure 1Flow diagram for Daily Trial and Nocturnal Trial. (a) Flow diagram for Daily Trial showing the number of patients enrolled and assigned to each study arm (intervention/control), and number of patients who completed the baseline and 12-month HRQoL measures, including reasons for dropout. (b) Flow diagram for Nocturnal Trial showing the number of patients enrolled and assigned to each study arm (intervention/control), and number of patients who completed the baseline and 12-month HRQoL measures, including reasons for dropout.View Large Image Figure ViewerDownload Hi-res image Download (PPT)Table 1Baseline characteristics of the Daily TrialCharacteristicsn (%)Mean ± SDMedian [25th, 75th percentiles]All patients (N = 245)3 times/wk (n = 120)6 times/wk (n = 125)Age (yr)50.4 ± 13.950 [42, 59]52.0 ± 14.152 [43, 60]48.9 ± 13.647 [41, 58]Male151 (61.6)73 (60.8)78 (62.4)Black race102 (41.6)53 (44.2)49 (39.2)Education (completed high school or less)109 (45.1)53 (44.5)56 (45.5)Primary language English196 (80.0)101 (84.2)95 (76.0)Duration of end-stage renal disease (yr) <272 (29.4)35 (29.2)37 (29.6) 2–576 (31.0)42 (35.0)34 (27.2) > 597 (39.6)43 (35.8)54 (43.2)Diabetes100 (40.8)50 (41.7)50 (40.0)Charlson Comorbidity Index1.82 ± 1.952 [0, 3]1.88 ± 2.032 [0, 3]1.76 ± 1.892 [0, 3]Predialysis serum albumin (g/dl)3.94 ± 0.423.94 ± 0.463.94 ± 0.37Predialysis hemoglobin (mg/dl)11.9 ± 1.2612.0 ± 1.2411.9 ± 1.28Dialysis Std Kt/Vurea2.52 ± 0.352.53 ± 0.392.50 ± 0.31Antidepressant35 (14.3)15 (12.5)20 (16.0)Opioid42 (17.1)19 (15.8)23 (18.4)Physical Health Composite (RAND short form-36)38.1 ± 10.538.0 ± 9.738.1 ± 11.2Mental Health Composite (RAND short form-36)45.1 ± 11.846.0 ± 10.344.3 ± 13.0Beck Depression Inventory score12.5 ± 9.012.4 ± 9.512.6 ± 8.6Std, standard. Open table in a new tab Table 2Baseline characteristics in the Nocturnal TrialCharacteristicsn (%)Mean ± SDMedian [25th, 75th percentiles]All patients (N = 87)3 times/wk (n = 42)6 times/wk (n = 45)Age (yr)52.8 ± 13.654 [43, 69]54.0 ± 12.954 [45, 62]51.7 ± 14.453 [42, 64]Male57 (65.5)28 (66.7)29 (64.4)Black race23 (26.4)11 (26.2)12 (26.7)Education (completed high school or less)34 (39.5)14 (33.3)20 (45.5)Primary language English77 (88.5)36 (85.7)41 (91.1)End-stage renal disease vintage (yr) < 258 (66.7)30 (71.4)28 (62.2) 2–513 (14.9)5 (11.9)8 (17.8) > 516 (18.4)7 (16.7)9 (20.0)Diabetes37 (42.5)18 (42.9)19 (42.2)Charlson Comorbidity Index1.72 ± 1.752 [0, 3]1.88 ± 1.932 [0, 3]1.58 ± 1.572 [0, 2]Predialysis serum albumin (g/dl)3.91 ± 0.493.92 ± 0.513.90 ± 0.48Predialysis hemoglobin (mg/dl)11.8 ± 1.1111.9 ± 1.0911.6 ± 1.12Dialysis Std Kt/Vurea2.34 ± 0.312.34 ± 0.342.35 ± 0.28Antidepressant22 (25.3)10 (23.8)12 (26.7)Opioid18 (20.7)7 (16.7)11 (24.4)Physical Health Composite (RAND SF36)37.8 ± 8.9738.2 ± 8.337.5 ± 9.6Mental Health Composite (RAND ± ± ± Depression Inventory ± ± ± standard. Open table in a new tab standard. standard. The baseline and follow-up HRQoL measures for patients assigned to frequent versus conventional hemodialysis in each trial are presented in Table The of the baseline HRQoL measures were similar in patients assigned to frequent compared with conventional hemodialysis in both with the of differences in the health and general health scale scores in the Nocturnal general measures of health-related quality of life in the Daily and Nocturnal observed baseline for randomized The observed 4 and patients with both baseline and 4 and both baseline and and ± and treatment and treatment effects were for the baseline value of each In the Daily Trial for clinical recovery time from and treatment effects from difference of on or with confidence from from ± ± ± ± to = ± to = ± ± ± ± ± ± ± ± ± to = ± to = ± ± ± ± ± ± ± ± ± to = ± to = ± ± ± ± ± ± ± ± ± to = ± to = ± ± ± ± ± health ± ± ± ± to = ± to = ± ± ± ± ± ± ± ± ± to = ± to = ± ± ± ± ± to recovery to to to to to = to Health The observed baseline for randomized The observed 4 and patients with both baseline and 4 and both baseline and and treatment effects were for the baseline value of each In the Daily Trial for clinical recovery time from and treatment effects from difference of on Open table in a new tab Health The of each HRQoL in follow-up is also presented in Table was completed by more than of after patients who or a kidney in follow-up were from patients in the Daily Trial and 3 patients in the Nocturnal Trial, and patients in the Daily Trial and patients in the Nocturnal Trial, The baseline score was in patients assigned to frequent hemodialysis and in patients assigned to conventional hemodialysis. 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Patients who to be randomized each trial a higher baseline HRQoL than patients who but were not and it the effects observed in these 2 trials will not to the hemodialysis M.V. B. Eggers et characteristics of in the Frequent Hemodialysis Network (FHN) and nocturnal J 2011; Full Text Full Text PDF PubMed Scopus Google Scholar these HRQoL measures were completed a time to each patient and not a time after a hemodialysis it this the of the In as compared with conventional thrice-weekly frequent in-center hemodialysis and frequent nocturnal hemodialysis both the time it to from a hemodialysis session. Frequent in-center hemodialysis also and in general measures of HRQoL. The FHN Daily and Nocturnal trials are 2 trials of frequent in-center hemodialysis and home nocturnal by the of Health of and and and the for and The and and of both the trials are as are the of randomization, and baseline clinical R.S. Garg A.X. Chertow G.M. et al.Frequent Hemodialysis Network (FHN) randomized trials: study design.Kidney Int. 2007; 71: 349-359Abstract Full Text Full Text PDF PubMed Scopus (192) Google Scholar patients receiving hemodialysis with the to in or were enrolled the 2 trials in the and and Trial Nocturnal Trial In the Daily Trial, we randomly assigned 245 patients to receive frequent times per week) or conventional times per week) in-center hemodialysis. In the Nocturnal Trial, we randomly assigned 87 patients to receive frequent nocturnal times per week) or conventional times per week) hemodialysis As the Daily Trial hemodialysis patients on 3 times weekly hemodialysis in hemodialysis were for and were for and 245 were randomized of who patients not to of the time for 3 per week and the in the trial R. et to and of the Frequent Hemodialysis Network (FHN) Daily Nephrol. 2012; PubMed Scopus Google Scholar not reported in a similar of and in the Nocturnal Trial. As previously patients randomly assigned the Daily Trial, compared with patients who but were not randomly higher baseline measures of M.V. B. Eggers et characteristics of in the Frequent Hemodialysis Network (FHN) and nocturnal J 2011; Full Text Full Text PDF PubMed Scopus Google Scholar The was also in the Nocturnal M.V. B. Eggers et characteristics of in the Frequent Hemodialysis Network (FHN) and nocturnal J 2011; Full Text Full Text PDF PubMed Scopus Google Scholar As previously frequent hemodialysis in more solute and fluid per with fluid for each hemodialysis G.M. Levin N.W. Beck G.J. et al.In-center hemodialysis six times per week versus three times per week.N Engl J Med. 2010; 363: 2287-2300Crossref PubMed Scopus (823) Google Scholar, 7Rocco M.V. Lockridge Jr., R.S. Beck G.J. et al.The effects of frequent nocturnal home hemodialysis: the Frequent Hemodialysis Network Nocturnal Trial.Kidney Int. 2011; 80: 1080-1091Abstract Full Text Full Text PDF PubMed Scopus (403) Google Scholar As previously a coprimary HRQoL in each of the FHN trials was the physical health score from the RAND 36-item health R.S. Garg A.X. Chertow G.M. et al.Frequent Hemodialysis Network (FHN) randomized trials: study design.Kidney Int. 2007; 71: 349-359Abstract Full Text Full Text PDF PubMed Scopus (192) Google Scholar This the number of patients who were to be randomized each of the trials (as for statistical to a to difference in the RAND G.M. Levin N.W. Beck G.J. et al.In-center hemodialysis six times per week versus three times per week.N Engl J Med. 2010; 363: 2287-2300Crossref PubMed Scopus (823) Google Scholar, R.S. Garg A.X. Chertow G.M. et al.Frequent Hemodialysis Network (FHN) randomized trials: study design.Kidney Int. 2007; 71: 349-359Abstract Full Text Full Text PDF PubMed Scopus (192) Google Scholar patient-reported measures of general health were collected the FHN and we analyzed these measures for this Patients and were of the of hemodialysis and As HRQoL were by in or a call by of group and M. 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