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Prepublished online as a Blood First Edition Paper on August 22, 2002; DOI 10.1182/blood-2002-03-0801.
CLINICAL OBSERVATIONS, INTERVENTIONS, AND THERAPEUTIC TRIALS
From the Centre for Allogeneic Stem Cell
Transplantation, Departments of Clinical Immunology and Hospital
Infection Control, Hematology, Karolinska Institutet, Huddinge
University Hospital, Stockholm, Sweden.
After myeloablative treatment and allogeneic stem cell
transplantation (SCT), patients are kept in isolation rooms in the hospital to prevent neutropenic infections. During a 3-year period, patients were given the option of treatment at home after SCT. Daily
visits by an experienced nurse and daily phone calls from a physician
from the unit were included in the protocol. We compared 36 patients
who wished to be treated at home with 18 patients who chose hospital
care (control group 1). A matched control group of 36 patients treated
in the hospital served as control group 2. All home care patients had
hematologic malignancies and 19 were in first remission or
first chronic phase. Of the donors, 25 were unrelated. The patients
spent a median of 16 days at home (range, 0-26 days). Before discharge
to the outpatient clinic after SCT, patients spent a median of
4 days (range, 0-39 days) in the hospital. In the multivariate
analysis, the home care patients were discharged earlier (relative risk
[RR] 0.33, P = .03), had fewer days on total
parenteral nutrition (RR 0.24, P < .01), less acute graft-versus-host disease (GVHD) grades II-IV (RR 0.25, P = .01), lower transplantation-related
mortality rates (RR 0.22, P = .04), and lower costs (RR
0.37, P < .05), compared with the controls treated in
the hospital. The 2-year survival rates were 70% in the home care
group versus 51% and 57% (not significant) in the 2 control
groups, respectively (P < .03). To conclude, home care
after SCT is a novel and safe approach. This study found it to be
advantageous, compared with hospital care.
(Blood. 2002;100:4317-4324) Over the past 30 years, allogeneic hematopoietic
stem cell transplantation (SCT) has emerged as a curative therapy for a
number of lethal disorders affecting the hematopoietic
system.1-5 After conditioning with high doses of
chemoradiotherapy, pancytopenia occurs and infectious complications,
including bacterial bacteremia, invasive fungal infections, and viral
infections, are common.6-9 During the pancytopenic phase,
the patients are kept in a protected environment, such as laminar air
flow rooms (LAF) or reversed isolation.10-13 Despite this,
infectious complications are common causes of morbidity and mortality
shortly after SCT.
Home care is mainly used for palliative care in end-stage cancer
patients and in geriatrics.14,15 However, there is some controversy regarding the quality of life and costs of home care as
compared with those of hospital care.16-19 In more recent
years, home care for outpatients has been given in some centers
performing autologous SCT.15 One study of SCT allowed
patients to leave their rooms and the hospital at will.20
Patients living close to the hospital were allowed to go home for a few
hours and sometimes overnight. We used another approach in our patients
who underwent SCT. After conditioning and transplantation in the
hospital, the patients were given the opportunity to be treated at home
during the pancytopenic phase. An experienced nurse from our unit
visited the patients once or twice daily until the patient could be
discharged to the outpatient clinic. To our knowledge, this has not
been done before. A pilot study including 11 patients treated at home in this way showed that the procedure was safe.21 In the
present study, we planned to treat 36 patients at home during the
pancytopenic phase; 2 of them could not go home for medical reasons. We
compared these 36 patients with 18 patients who were offered home care, but preferred hospital care. Since some of these patients might have
been less psychologically fit than those treated at home, we also
compared a second control group of 36 patients, matched for various
risk factors, with the home care group. They came from other parts of
Sweden, or abroad, where home care was not possible, because they lived
too far from the hospital. The aim of the study was to compare outcome
of home care with hospital care after SCT.
Patients and patient selection for home care
Information
Conditioning Conditioning consisted of 60 mg/kg cyclophosphamide (Cy) for 2 days, combined with 10 Gy of total body irradiation (TBI), single fraction, with the lungs shielded to receive no more than 9 Gy, or fractionated 3 Gy daily for 4 days.22 The amount of 4 mg/kg per day busulfan (Bu), divided into 4 doses given for 4 days (total dose 16 mg/kg), was adjusted to the Bu levels.23,24 It was combined with 60 mg/kg Cy for 2 days. A few patients were given reduced conditioning including 30 mg/m2 per day fludarabine for 6 days, combined with 4 mg/kg per day Bu for 2 days (total dose 8 mg/kg), combined with 2 mg/kg per day thymoglobulin (Sangstat, IMTIX, Lyons, France) for 4 days.25 In patients who received unrelated grafts, 2 mg/kg per day thymoglobulin was given for 2 to 4 days before SCT.22,26Centre infrastructure and outpatient management The Centre for Allogeneic Stem Cell Transplantation (CAST) has 12 single rooms, 6 with reversed isolation. There are 6 doctors, 15 nurses, and 10 assistant nurses. Every day we have at least 4 doctors, 4 nurses, and 3 assistant nurses at the ward and one nurse for home care during daytime. During nights we have one doctor on call and 2 nurses in service at the ward. We have one senior doctor on call at home. After discharge from CAST, adult patients are referred to the outpatient clinic at the Department of Hematology and children to the Department of Pediatric Hemato-oncology. At the outpatient clinic, check-ups are performed twice weekly for the first 3 months and thereafter less frequently, dependent on the status of the patient. When patients are readmitted to the hospital, adults are cared for at CAST and children at the Department of Pediatrics.Home care After the graft had been infused, the patients could go home. An experienced nurse from the ward visited the patient once or twice daily, for a median of 1 hour (range, 0.5 to 3 hours), depending on the needs of the patient. The nurse checked vital signs, including temperature and blood pressure, and examined the patient's mouth for mucositis, herpes lesions, and fungi, as well as the skin for acute graft-versus-host disease (GVHD) or other lesions. In the morning, the nurse took blood samples from the central venous line (10-25 mL/d) and gave intravenous medications, erythrocyte transfusions if the patient had a hemoglobin (Hb) level less than 80 g/L, and platelet transfusions when the platelet count fell below 30 × 109/L, or if there were signs of hemorrhage.21-23,26 If the patient's fluid intake was less than 2 liters in 24 hours and weight had decreased by more than 2 kg, parenteral nutrition was started. If the patient could not feed himself or herself at all, total parenteral nutrition (TPN) was given. Mucosal pain was treated with oral paracetamol or oral morphine. If this was not sufficient, continuous intravenous morphine was given, using a home pump. If the nurse needed any advice, she called the physician at the ward when she visited the patient. At the hospital, the nurse and the physician went through all the clinical and laboratory data. After this, the physician called the patient to tell him or her about the chemistry results, to check the patient's status, and to change medications, if needed. The patient was asked to take his or her temperature frequently and if it rose above 38.5°C, the patient was to call the unit and return to the hospital. This was done to ensure that the patient did not develop septic shock or acute respiratory distress syndrome at home. Blood cultures and a chest x-ray were taken at the SCT unit and intravenous antibiotics were started. The patient received a check-up in the hospital for an infection and, if the patient felt well, he could go home even with a fever; intravenous antibiotics were continued at home. Criteria for admission to the ward were (1) deterioration of the patient's condition, (2) if the patient's temperature rose above 38.5°C, at least twice, (3) if the patient needed intravenous injections more than twice daily, and (4) if the caregiver was unable to stay at home and support the patient. Before admission to the ward, the patient or the caregiver always contacted the responsible physician.Hospital care Patients being cared for at the hospital were treated in conventional single rooms with reversed isolation and a relative or friend could stay with them.22 They could take a walk outside the hospital after 6:00 PM on weekdays and during weekends.21,22,26 Patients treated in the hospital and at home were asked to avoid persons with symptoms of or having contagious diseases, going near construction areas when they were out walking due to the risk of aspergillosis, visiting anyone, and shopping. Patients in the hospital participated in a prospective randomized trial comparing platelet transfusions when platelet counts fell less than 30 × 109/L versus less than 10 × 109/L.Infection prophylaxis Infection prophylaxis was the same for the home care patients as for those treated in the hospital. During conditioning, all patients started with gut decontamination consisting of 500 mg oral ciprofloxacin twice a day and 250 mg amphotericin B once a day until neutrophils were more than 0.5 × 109/L. Co-trimoxazole was given as prophylaxis against Pneumocystis carinii during conditioning until 2 days before transplantation and after SCT when the absolute neutrophil count (ANC) was more than 0.5 × 109/L and was maintained for 6 months. To avoid myelotoxicity induced by co-trimoxazole, 15 mg leukovorin was given intravenously once daily until ANC was more than 0.5 × 109/L. Leukovorin was not given the day before or on the day when methotrexate injections were given. To prevent oral candidiasis, mycostatin was given from the day of SCT once a day for the first 3 months after transplantation. Patients with a herpes simplex virus immunoglobulin G (IgG) titer of more than 10 000 (determined by enzyme-linked immunosorbent assay [ELISA]) received oral or intravenous acyclovir prophylaxis until ANC was more than 0.5 × 109/L. Granulocyte colony-stimulating factor at 5 µg/kg per day was given from day +10 after SCT until ANC was more than 0.5 × 109/L for 2 consecutive days.Blood cultures were taken the first time the patient had a temperature of more than 38.5°C and cultures from urine, nasopharynx, stool, or the central venous line incision were taken, when indicated. Subsequent blood cultures were obtained when patients had a high fever and chills or in the event of a continuous fever, 2 to 3 times weekly. Immunosuppression and donors Cyclosporine (CyA) combined with 4 doses of methotrexate was given as prophylaxis against GVHD.22,23,26,27 One patient in the home care group with a twin donor received no prophylaxis. Only a few patients were given CyA and prednisolone (Table 1). Of the donors in the home care group, one was an identical twin, 10 were HLA antigen-identical siblings, and 25 were HLA-A-, HLA-B-, and HLA-DR 1-compatible unrelated. HLA antigen matching criteria were the same for the home care and the hospital care patients. In
control group 1, 7 donors were HLA antigen-identical siblings and 11 were unrelated donors. In control group 2, 12 donors were HLA
antigen-identical siblings and 24 were unrelated donors. Details regarding treatment have been reported elsewhere in
detail.22,23,26
Monitoring Patients at home were monitored using the same charts and chemistry as patients in the hospital. Patient therapy compliance was noted in the charts.Statistics The Fisher exact test was used to compare the distribution of patients with bacteremia and the Mann-Whitney U test to compare days with fever, TPN, antibiotics, transfusions, and other data. The probability of GVHD, transplantation-related mortality (TRM), relapse, leukemia-free survival (LFS), and survival rates were compared using the method of Kaplan-Meier with the log-rank test (Mantel-Haenszel).28 Cox regression model was used for the multivariate analysis.29 Factors with P = .1 in the univariate analysis were included in the multivariate analysis. The following factors were analyzed: home care or hospital care, type of donor (sibling/unrelated), source of stem cells (BM vs PBSC), diagnosis, stage of disease (early was defined as first remission or chronic phase; late was defined as more advanced), sex, age, cytomegalovirus (CMV) serology, fever, bacteremia, acute GVHD (grade 0-I vs grade II-IV), time to engraftment, absolute neutrophil count (ANC more than 0.5 × 109/L), nucleated cell dose, donor age, donor sex, and female donor to male recipient. Home care was the main factor to be tested whereas all the other factors were included to control for differences between the groups. To correct for multiple comparisons a Bonferroni correction was made. As 5 multivariate analysis were made, the new significance level will be .05/5 = .01. Only patients surviving more than 30 days were included in the analysis of acute GVHD. A minimum of 90 days of follow-up was a criterion for relapse and chronic GVHD.Calculation of costs The costs were calculated from the day of transplantation. The calculation did not include costs prior to transplantation, such as tissue typing, donor search, cell harvest, and so forth. The costs, calculated in US dollars as $1084 per day in the hospital, included medication, hospital bed, and staff. The same costs were calculated for patients staying at home, because the ward also served as a back-up for the home care patients. The costs were calculated until day 76, that is, the last day of discharge from the hospital among the control patients (Table 2). Every visit to the outpatient clinic was estimated at $200. The cost per day when patients were readmitted to the ward was $798. This calculation does not include loss of income to patients and caregivers. Such costs are covered by the health insurance system in Sweden. Patients in the hospital could also have a relative or a friend staying with them. The health care system in Sweden pays for a relative for 60 days as a caregiver.
Days at home in the home care group Among the 36 patients in the home care group, 2 never went home because they were too sick to leave the hospital. The others went home on median day +1 after the transplantation (range, 0-8 days). One patient had to wait until day 8 because she had no caregiver at home until then. Of the 34 patients who went home, 21 were readmitted to the ward on 33 occasions, median 1 day (range, 0-25 days), because of fever (n = 24), no caregiver at home (n = 2), diarrhea and/or fever and/or pain (n = 3), pain (n = 1), GVHD (n = 1), nausea and vomiting (n = 1), and mucositis (n = 1).The time to discharge to the outpatient clinic was significantly faster
in the home care group than in the control groups
Fever and infections We found no difference in the number of days with fever of 38.5°C or higher in the home care group versus the control groups (Table 3), but, significantly more blood cultures were taken in the 2 control groups than in the home care group (P = .01). Bacteremia occurred in 25% of patients in the home care group versus 44% and 39% in the 2 control groups, respectively (Table 3, ns). In the multivariate analysis, bacteremia was associated with a male recipient (P < .05). The number of days on intravenous antibiotics was the same in the 3 groups (Table 3).Engraftment and transfusions Engraftment, time to a white blood cell (WBC) count of more than 0.2 × 109/L, time to an ANC of more than 0.5 × 109/L, and time to a platelet count of more than 30 × 109/L were similar in the home care group and the control groups (Table 3, Figure 1A). Likewise, we found no difference in number of platelet transfusions in the home care group and the controls. However, control group 1 needed significantly more erythrocyte transfusions (median 7 vs 4) than the home care group (Table 3, P < .05).Analgesics and TPN A median of 1 day on analgesics in the home care group was significantly lower than a median of 15 in control group 1 (Table 3, P < .05). In the multivariate analysis, intravenous analgesics were associated with CMV seropositivity in the recipient and/or donor (Table 5). A median of 4 days on TPN in the home care group was significantly shorter than 23 and 10 days in the control groups 1 and 2, respectively (Table 3, P < .001, P < .01). In the univariate analysis, days on TPN was associated with hospital care, delayed engraftment, CMV reactivation, and bacteremia (Table 4). In the multivariate analysis, TPN was associated with hospital care and delayed engraftment (Table 5).GVHD and TRM The probability of grades II-IV acute GVHD in the home care group was 17%, which was significantly lower than 42% and 45% in the control groups 1 and 2, respectively (Figure 2, P < .05). In the univariate and multivariate analyses, acute GVHD grades II-IV was associated with hospital care and PBSCs, as compared with BM as the cell source (Tables 4 and 5). TRM was 8% in the home care group, which was significantly better than 49% and 35% in the control groups 1 and 2, respectively (Figure 3, P < .01, P = .02). In the univariate and multivariate analysis, TRM was associated with acute GVHD, hospital care, and bacteremia (Tables 4 and 5).
Reasons for death and survival The reasons for death in the 3 groups are listed in Table 6. The 2-year survival rate was 70% in the home care group (P < .03), compared with 51% and 57% in control groups 1 and 2 (Figure 4). In the univariate analysis, death was associated with acute GVHD grades II-IV, bacteremia, and hospital care (Table 3). In the multivariate analysis, death was associated with GVHD and bacteremia (Table 4).
Bonferroni correction After correction for multiple analysis (Bonferroni correction), home care was statistically associated with fewer days on TPN (P < .01) and a lower incidence of acute GVHD grades II-IV (P = .01) (Table 5).Quality of life All patients and their caregivers answered an anonymous questionnaire when they were discharged to the outpatient clinic. No patient treated at home regretted this decision. They were glad to stay with their families and to take part in activities at home and walk when they felt like it. One patient given reduced conditioning and treated at home was a 57-year-old lawyer with myelodysplastic syndrome (MDS). He took a walk to and spent a couple of hours at his work every day. A 54-year-old woman with AML M4, treated with complete myeloablative therapy, got up every morning at 6:00 AM when the nurse arrived and invited her to coffee. She made her bed every day and did the laundry to get some exercise. A 15-year-old boy with AML M4 having car sickness declined to visit the hospital to see the physician who wished to examine his blisters. The physician therefore went to his home instead.Costs The median cost of treatment from day 0 until day +76 was $25 340 for the home care group, compared with $36 437 for control group 1 (P < .001) and $33 620 for control group 2 (P < .05, Table 2). In the multivariate analyses, high costs were associated with late engraftment, acute GVHD grades II-IV, and hospital care (Table 5).
This study of home care during the pancytopenic phase for patients who underwent SCT used experienced nurses from the Stem Cell Transplant Ward and was supported by a grant from the Swedish Cancer Society for 3 years. The main reason for the project when it started was to allow the patient to be treated at home instead of in a hospital. The first aim was to find out whether home care was safe and useful for the patients and their relatives. The trial was not randomized because we wished to treat as many patients as possible at home during this period. Many people opposed this because they thought the patients might die at home. Therefore, the pediatricians initially refused to have children participate in the study; only adults were included. To reduce the risk of sudden death at home (eg, from septic shock or the adult respiratory distress syndrome), patients were taken to the hospital when they had a fever of more than 38.5°C. Many of them (62%) were readmitted to the unit. However, after a median of 1 day in the hospital, they could go home again and and stay there. The first patients and their caregivers were very enthusiastic and, after 17 months, 11 patients had been treated at home. We then did a safety evaluation of the study.21 At that time, 22 patients had been given the choice of being treated at home. There were 11 patients who could not be treated at home, and they served as controls. In this evaluation, we found to our surprise that the patients treated at home had bacteremia less often, spent fewer days on TPN, had fewer erythrocyte transfusions, and had fewer days on intravenous antibiotics and intravenous analgesics than the controls. This preliminary study indicated not only that it was safe to be treated at home during the neutropenic phase after SCT, but better in many respects than isolation in the hospital. As the study continued, more patients wanted to be treated at home and 2 children, 14 and 15 years of age, were included. Although 36 patients had agreed to be treated at home, 18 were not because they had no caregiver, felt safer in the hospital, and so forth. We were criticized for selecting controls who were eligible for the home care project but who could not take part in it. This could have introduced a bias in which the controls treated in the hospital were more or less psychologically fit and had a worse outcome than those treated at home. To overcome this problem, we added another control group consisting of 36 patients who could not be offered treatment at home because they lived too far away from the Stockholm area. These controls were matched for as many prognostic variables as possible (Table 1). On the whole, they are typical of those who have undergone a transplantation in our unit during the past few years. For instance, we use more unrelated donors than HLA antigen-identical siblings and PBSCs more frequently than BM.26,30 The home care group had several advantages compared with the 2 control groups. They could be discharged to the outpatient clinic faster although the times to engraftment of ANC and platelets were the same (Table 3). Since the home care patients usually took care of their food and medication themselves, they could be discharged to the outpatient clinic earlier than those treated in the hospital who more often had trouble in eating. Other reasons for an earlier discharge may be that the home care patients could eat and drink more and therefore required less TPN than the controls treated in the hospital, and were more active and therefore had a better appetite. They could also go to their own kitchen whenever they wanted and take something they were used to and liked to eat. They probably felt more like eating because they could eat their meals together with their families. The larger space and the walks outside may also have stimulated the appetite. They also may have forced themselves to eat because of the wish to stay at home. We also found that the home care patients were less likely to develop grades II-IV acute GVHD than the controls (Figure 2, Tables 4 and 5). The reasons for this may have been better nutrition and maybe a trend for less bacteremia. Infections can lead to GVHD. For instance, gnotobiotic mice have a lower risk of developing GVHD.31,32 A clinical study showed that patients treated in laminar air flow rooms were less likely to develop GVHD than those treated in regular hospital rooms.33 Because of the lower risk of GVHD in the home care group, TRM was also significantly lower in this group than in the controls (Figure 3, Tables 4 and 5). In the safety analysis of this study, the main concern was the risk of septic shock or the adult respiratory distress syndrome, which are fatal complications. However, none of the patients in the 3 groups died of these conditions. Another concern was whether the risk of an Aspergillus infection would increase in the home care patients, who were not isolated. However, so far, no patient has acquired a clinical Aspergillus infection. Indeed, such infections were rare in our patients who underwent SCT.7 This may be due to our cool climate, since other studies have reported reduced Aspergillus infection rates in patients who underwent SCT who are strictly isolated.12,34 In the analysis of TRM and survival, the disease and stage of the disease were not significant in comparison with GVHD, bacteremia, and hospital care. One reason for this may have been the short follow-up because only a few patients so far have had a relapse of their hematologic malignancy (Table 6). Relapse is otherwise a major cause of mortality after SCT for hematologic malignancies.1-5 It is obvious that most patients who were given the opportunity to be treated at home appreciated this option. Unfortunately, this could only be offered to those living close to the hospital and a specialized SCT unit. Indeed, no patient regretted this decision. As regards the quality of life, we could not compare the groups, because most of those treated in the hospital were not eligible for treatment at home. As regards costs, it was cheaper to be cared for at home because home care patients were discharged earlier to the outpatient clinic (Tables 2, 3, and 4). Home care is probably also cheaper than hospital care because home care patients required less TPN and antibiotics and, in addition, TRM was reduced and more lives were saved. Furthermore, fewer nurses and doctors were needed and the hospital beds could be used more efficiently. Home care can function only if experienced nurses from an SCT unit and hospital beds are available when needed in case of an emergency or high fever. Then, home care can be used to supplement hospital care for patients living near specialized SCT units. There are several differences favoring the home care arm. With the Bonferroni correction, it cannot be excluded that the lower TRM may be influenced by chance. Still, the study provides evidence that patients are not put at risk by being treated at home. To conclude, home care during the pancytopenic phase after SCT is a novel and safe approach. According to this study, home care had several advantages (eg, faster discharge, reduced need for TPN, a lower incidence of acute GVHD, lower TRM, and lower costs) over treatment in the hospital. This study should be used as the basis for a prospective randomized study comparing home care with hospital care after SCT.
We thank the caregivers and the patients who participated in this study. We also thank all nurses (especially Birgitta Bjurman), physicians, and other staff who helped in this study; Inger Hammarberg for secretarial help; Bengt Jönsson, professor of Health Economics, Stockholm School of Economics, for advice regarding evaluation of costs; and Bo Nilsson, BSc, Department of Cancer Epidemiology, Karolinska Institutet, for statistical advice; and editor Francis Walsh and Dr Zoe Walsh for checking the language. This article is dedicated to Dr Karl-Erik Myrbäck, former head of the Department of Hospital Control, Huddinge University Hospital, for his belief in this project when so many were against it. He was an enthusiastic coworker in this project, but died tragically before it was finished.
Submitted March 14, 2002; accepted July 15, 2002.
Prepublished online as Blood First Edition Paper, August 22, 2002; DOI 10.1182/blood-2002-03-0801.
Supported by grants from the Swedish Cancer Society (999508 and 0070-B99-13XAC), the Children's Cancer Foundation (1997/073), the Swedish Medical Research Council (K2000-06X-05971-20A), the Cancer Society in Stockholm, the Tobias Foundation, the FRF Foundation, and Karolinska Institutet.
Karl-Erik Myrbäck died on June 19, 2001.
The publication costs of this article were defrayed in part by page charge payment. Therefore, and solely to indicate this fact, this article is hereby marked "advertisement" in accordance with 18 U.S.C. section 1734.
Reprints: Britt-Marie Svahn, Ward Director, Centre for Allogeneic Stem Cell Transplantation, Huddinge University Hospital, B87, SE-141 86 Stockholm, Sweden; e-mail: b-m.svahn{at}transpl.hs.sll.se.
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Abstract
Introduction
that is, median 19 days versus 29 days (Table 
