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Transfusions at home in patients with myelodysplastic syndromes
Leukemia Research 36 (2012) 684–688
Contents lists available at SciVerse ScienceDirect
Leukemia Research journal homepage: www.elsevier.com/locate/leukres
Transfusions at home in patients with myelodysplastic syndromes Pasquale Niscola a,∗ , Andrea Tendas a , Marco Giovannini a , Luca Cupelli a , Malgorzata Monika Trawinska a , Massimiliano Palombi a , Laura Scaramucci a , Gregorio Antonio Brunetti b , Alessio Perrotti a , Benedetta Neri a , Fabio Efficace c , Claudio Cartoni b , Paolo de Fabritiis a , Franco Mandelli d a
Hematology Unit, S. Eugenio Hospital, Rome, Italy Hematology, Department of Cellular Biotechnologies and Hematology, University “La Sapienza”, Rome, Italy Data Center and Health Outcomes Research Unit of the Italian Group for Adult Hematologic Diseases (GIMEMA), Rome, Italy d AIL (Italian Association Against Leukemias, Lymphomas and Myeloma), Rome, Italy b c
a r t i c l e
i n f o
Article history: Received 29 September 2011 Received in revised form 12 January 2012 Accepted 18 January 2012 Available online 14 February 2012 Keywords: Chronic anemia Frail patient Home care Managed care Myelodysplastic syndromes Transfusions at home
a b s t r a c t We report descriptive data of a home care (HC) program, throughout a 5-years period (2006–2010), focusing on the reliability and the safety of transfusions at home in 211 patients affected by myelodysplastic syndromes (MDS). Our results outline the potentially relevant role of a specifically dedicated HC service in the global management of frail MDS patients for which transfusions at home may represent a valuable option to maintain a good quality of life and avoid the possible discomfort due to hospital admissions and outpatient visits. © 2012 Elsevier Ltd. All rights reserved.
1. Introduction Myelodysplastic syndromes (MDS) are a heterogeneous group of bone marrow disorders [1] with a higher incidence in the elderly [1–3]. Chronic anemia is one of the main clinical features of MDS [1,4] and can greatly compromise patients’ quality of life (QoL) [5,6]. Although erytropoietic stimulating agents (ESAs) and novel agents may provide some clinical benefits and prolonged transfusion independence in many patients [1,7–9], regular administration of red blood cells (RBCs) concentrates continues to represent the only effective measure for most of the patients [7–9]. Appointments for medical visits, blood sample collections and transfusions, could thus represent an additional burden for these patients as they are typically provided on outpatient basis. Therefore, discomfort arising from driving distances and long waiting times in the hospital may often be important issues that could further complicate an optimal management of MDS patients and this might be particularly true for elderly patients, for those with medical comorbid
∗ Corresponding author at: Hematology Unit, S. Eugenio Hospital, Piazzale dell’Umanesimo 10, Rome 00144, Italy. Tel.: +39 0651002454; fax: +39 0651003245. E-mail address: [email protected] (P. Niscola). 0145-2126/$ – see front matter © 2012 Elsevier Ltd. All rights reserved. doi:10.1016/j.leukres.2012.01.010
conditions [10,11] or physical impairments [12–14] and social difficulties. Relying on family members or friends for travels to hospital for visits and transfusions, may also be an additional concern and stressful factor for some patients and their families [15,16]. The above mentioned issues illustrate how challenging could be, for some patients, to follow an outpatient care program on a regular basis. Hence, choice of the clinical setting in which RBCs transfusions can be administered could be a critical aspect of the management of MDS patients. In particular, for patients with higher risk MDS and a limited life expectancy or managed with palliative and supportive care, home care (HC) could represent, wherever possible, the most appropriate approach potentially helping patients maintain a good QoL [17–19]. Previous work has shown the potential role of HC in the global management of patients affected by hematological malignancies [20–25], for whom transfusion therapy is the most frequently provided domiciliary intervention [20,23]. This is particularly true for MDS patients with functional impairments [21–24]. In this paper we report the results from the experience of our hospital-based HC service throughout a 5-year period, describing patients’ characteristics, clinical indications, operating procedures and feasibility. We also focus on safety issues in the management of RBC transfusions in MDS patients at home.
P. Niscola et al. / Leukemia Research 36 (2012) 684–688
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Table 1 Summary of home transfusion criteria adopted by our team. Inclusion criteria Patient and disease
Caregiver Home environment
Patient living in Rome or within the near urban area covered by our HC service. Disease-related chronic anemia refractory to all conventional measures, including ESAs. Physical limitations and/or compromised clinical and personal status. Social and family problems resulting in the impossibility to travel to the hospital and to attend clinical visits and transfusions. Stable medical conditions.a Adequate venous access. Informed and written consent. Responsible, capable and collaborating adult suitable at home. Other than a family member, caregiver would be also a friend or a home-aid assistant. Deemed adequate and suitable for a HC program. In particular, the home should be deemed easily accessible, clear, comfortable and safe to perform the transfusion. Availability of a functioning telephone.
Exclusion criteria Patient and disease
Caregiver Home environment
Patient’s refusal. Urgent transfusion in emergent clinical situations.a Inadequate vascular accesses. Sepsis.a Anemia due to underlying causes (hemolysis, active bleeding, iron and vitamins deficiency and so on) potentially resolvable by other measures (vitamins, iron, steroids, correction of a coagulation defect, surgery and so on) whenever applicable.a Positive indirect antiglobulin test (recipient serum – donors blood cross matching) and no antigen-negative donors RBCs units (both for autoantibodies and alloantibodies). Unresolved and/or undiagnosed fever, cardiovascular instability and/or others active clinical illnesses.a History of previous severe transfusion-related adverse reactions.a Patient living alone; no capable and responsible adult suitable as caregiver. Poor home conditions; home deemed unsafe and unsuitable for transfusion.
HC, home care; ESAs, erytropoietic stimulating agents; MDS, myelodysplastic syndromes; RBC, red blood cells. a For patients on a palliative care program, such as terminally ill patients, these criteria were considered on a case to case basis.
2. Patients and methods This retrospective study included 211 MDS followed up in a hematological HC program of St. Eugenio Hospital of Rome throughout a 5-year period (2006–2010). Patients have been admitted to hematological HC program. This HC program has been financially supported by the largest Italian Hematological Patient Association (i.e. the Roman Section of the Italian Association against Leukemias, Lymphomas and Myeloma, RomAIL) since 2006. Our staff is multidisciplinary and includes hematologists, nurses, psychologists, social workers and other health-care providers trained in hematology, palliative care and rehabilitation medicine [23,25]. The eligibility criteria for entering patients in the HC program are carefully assessed during an initial interview with the patient and the “designated” caregiver. The availability at home of a capable adult, as reliable caregiver, is the main inclusion criteria to allow patients entering the HC program. According to our working model, the caregiver, usually a member of the family is considered a key active player of our HC staff. In particular, the care giver is well informed and instructed, from the very beginning, about delayed transfusion-related reactions so as to allow him/her promptly identify adverse and relevant symptoms and inform our team. The patient’s informed consent is routinely obtained before the first home transfusion. A previous history of hospital transfusion is not considered an essential condition to take patients in the HC program. Written guidelines for the management of HC transfusion, of eventually occurring clinical complications, and criteria for the rapid admission of patients in case of severe adverse events, eventually unmanageable at home, have been developed and used as standard practice guidelines. The HC team closely works with general services and diagnostic structures of St Eugenio hospital. In particular a close relationship and collaboration with the blood transfusion service (BTS) of our hospital was established. Transfusion therapy is provided as part of a global HC program and is prescribed and supervised by our specialized and multidisciplinary trained staff basing on our institutional established transfusion criteria (Table 1) and operating model (Table 2) as well as in accordance with the Italian law, local regulation and previously reported guidelines on home transfusion [18,26,27]. The responsibility for home transfusion relies on the attending hematologist and on the nurse. The former evaluates the patient’s clinical status and the laboratory results. RBCs units are requested to the BTS of our hospital according to hemoglobin (Hb) levels (Hb < 8 g/dl) and/or to the clinical status and the symptom burden reported by the patient. In particular, a higher Hb threshold (Hb < 10 g/dl) is requested for patients with active cardiac and respiratory diseases. The attending hematologist assists the patient at home for all the duration of the transfusion and follows all aspects of the entire course of the HC program; moreover, all medications, such iron chelators, were given according to current practice guidelines for MDS [8,9]. The nurse is responsible for the maintenance of an adequate venous access, for the collection of blood samples for compatibility tests and for their safe transport in an adequate container to the BTS. Both the nurse and the hematologist are responsible to ensure
that drugs (such as adrenaline, chlorphenamine and hydrocortisone), materials and devices to handle any emergency are available at home before transfusions. Also all team members have to ensure the continuity of the therapeutic relationship with the patient and caregiver, reporting any delayed reactions by regular telephone contacts.
3. Results Overall, all 211 MDS patients were included in the HC program and received transfusions at home. Only 5 patients did not meet the inclusion criteria and were excluded from this HC program. Patient’s characteristics at the enrolment in the HC program are shown in Table 3. In general, the majority of patients had an adequate venous access and no long-term venous access by a central venous catheter (CVC) or long-line peripherally inserted central catheters (PICC) were requested as mandatory condition before the inclusion in the HC program; the temporary venous accesses to perform pretransfusion blood collection and the infusion of blood components were positioned and maintained by nurses or by physicians of our HC service for the time strictly necessary. Out of 211 patients, 174 (82%) were transfusion dependent at the start of the HC program. The remaining 37 (18%) failed ESAs and became transfusion-dependent during the HC program. At the enrolment to the HC program, median baseline Hb concentration was 8.3 (7.4–10.1) g/dl. Severe non-hematologic comorbidities were seen in 183/211 (87%) patients, with a median number of comorbid illnesses of 2 (0–6) per patient; cardiovascular and neurological diseases prevailed (Table 3). Median duration of HC was 9.2 (1–41) months. Among 211 patients, 37 (18%) patients received their first transfusion at home. Patients were followed at home for a median of 9.2 (1–41) months after the inclusion in the HC program. The median number of RBCs packages transfused for patient was 38 (range 1–162) for a total of 7766 units that were given in 4980 domiciliary transfusions. The median Hb level for which RBCs units were requested was 8.2 (range 6.9–9.8) g/dl. Nearly
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Table 2 Operating model of home transfusion. Tasks
Team member(s)
Comment
Decision making, refining indication to RBCs transfusion.
Hematologist
Definition of blood group. RBCs request to BTS.
Hematologist – Transfusionist (BTS) Hematologist
Pre-transfusion sample collection visit.
Nurse
Transport of blood samples to BTS for compatibility tests. Preparation of RBCs units and compatibility test.
Nurse
The common transfusion threshold adopted should be 8 g/dl; in individual patients with symptomatic anemia and in those with severe cardiorespiratory diseases, a higher transfusion threshold should be adopted. Blood group definition should be performed at entry. Maximum of two RBC units for each transfusion. In case of extremely severe anemia (Hb < 6 g/dl) a number of units greater than 2 could be requested by transfusing however separately with a break of more than 24 h. Blood sample for compatibility tests should be provided within 96 h prior the expected date of the transfusion; after 96 h, a new sample is required. A safe transport container should be used.
Positioning and maintenance of venous access.
Nurse
Transport of RBCs units from the BTS to patient’s home. Administration of transfusion (each RBC unit should be transfused in 1.5–2.0 h at a rate of 3 mL per minute; not plus than 2 RBC units for each transfusion).
Hematologist or caregiver Hematologist with or without the assistance of a nurse.
Patient’s surveillance and monitoring.
Hematologist
Collection of all transfusion-related wastes and its return to the hospital. Seeking the medical attention in case of emerging symptoms potentially referable to delayed transfusion-related adverse reactions. Call the patient 24 h after the transfusion.
Hematologist
Transfusionist (BTS)
Caregiver, Hematologist
Full compatible and leukoreduced blood components should be used. Saline-washed or irradiated RBCs units should be used where indicated and requested. According to the patient’s clinical needs, pooled platelet concentrates, single-donor platelet aphaeresis and fresh frozen plasma can be also requested and infused at home. According to the patient’s preference and the status and the availability of venous accesses, a needle-cannula would be placed by the nurse at the time of the pretransfusion blood collection and then maintained until the transfusion. A safe and refrigerated transport container should be used. Major drugs, materials and devices for the treatment of any adverse reactions (such as adrenaline, chlorphenamine and hydrocortisone) should be present at home before the start of the transfusion. At least one capable adult designated as caregiver should be present for all the duration of transfusion. All the duration of transfusion and at least 30 min after the end of the procedure. A safe and appropriate disposal should be guaranteed. The care giver should be appropriately informed and instructed about delayed transfusion-related reactions to allow prompt symptom identification and communication. Regular telephone contacts are recommended to ensure the continuity of the therapeutic relationship with the patient and to support the caregiver and record any delayed reactions not yet communicated.
Nurse or hematologist
RBC, red blood cells; BTS, blood transfusion service.
all transfusions were safely administered at home without any serious adverse effect (Table 4). Mild complications, such as mild allergic, urticarial and febrile non-hemolytic transfusion reactions occurred in 12 (0.0024%) of 4980 domiciliary for transfusions and were observed in 11 (5.2%) of 211 patients (Table 4). However, all complications were managed at home and no hospital admissions due to home transfusions were recorded. No particularly difficult venous access were recorded; only 4 (2%) of 211 patients had a CVC at the time of the inclusion in the HC program. Thereafter, during the HC program, additional eight (4%) patients required hospital admission because of the need of a PICC or a CVC. HC service
Table 4 Home transfusion (4980 transfusionsa ): clinical complications. Adverse reactionsb
Table 3 Patient’s characteristics. Age Sex Median baseline Hb level Physical disability
Comobidities
and transfusion at home were highly appreciated by patients and their families. No complaints or withholding from the HC program on patient’s request were recorded. Disease evolution into acute myeloid leukemia (AML) occurred at home in 59 (28%) out of 211 cases; hydroxycarbamide was administrated with palliative intent, given the compromised clinical status of affected individuals, none of them being eligible to receive intensive chemotherapy or other disease-modifying treatments.
Cardiovascular Neurological Diabetes Associated cancer Pulmonary Kidney Peptic Ulcer Liver
85 years (69–98) 85 male, 126 female 8.3 (7.4–10.1) 162/211 (77%) 64/211 (30%) 48/211 (23%) 41/211 (20%) 29/211 (14%) 25/211 (12%) 23/211 (11%) 22/211 (10%) 13/211 (6%)
Extravasations/vascular access related hematoma Fever (>38 ◦ C) Cardiorespiratory symptoms (fluid overload and others complications) Skin rash Nausea and vomiting Total
Number of complication events (%) 6 (0.0012) 2 (0.0004) 2 (0.0004)
1 (0.0002) 1 (0.0002) 12 (0.0024)
a A maximum of 2 red blood cell units have been administered for each transfusion. b All adverse reactions were managed at home; a rapid resolution and an uncomplicated outcome were observed in all cases.
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Table 5 Advantages and disadvantages of transfusion at home compared to hospital. Advantages
Logistic Psychological Medical QoL Safety and liability
Costs
Social and Economic Disadvantages
Logistic and organizational Medical
Safety and liability Regulatory and legal concerns
Costs
4. Discussion In our hematological department, a HC program, financially supported by a national Patient Association (AIL), was implemented with the aim of managing frail hematological patients outside the traditional in-hospital model of care. An additional aim in setting up this program was that of improving QoL for patients and their families and to optimize the use health economic resources [23,28–30]. The development of alternatives to hospitalization for MDS patients raises the question of the safety and the feasibility of home blood transfusion, which may be indicated under specific conditions (Table 1). On the basis of our data and on the ground of current knowledge in this area [18,24], pro and cons of blood transfusions at home are summarized in Table 5. According to our experience, RBC transfusions at home were feasible, reliable, effective and well accepted by older MDS patients, avoiding personal and family’s distress and possible social and economic costs due to travels to hospital. The main limitation of the present report is that not providing quantitative on patients’ QoL, as we did not implement a formal QoL assessment for these patients. We are currently implementing such patient-reported QoL outcomes to provide evidence base data on the value of our approach. Also, we cannot draw conclusions on cost as we did not perform a cost analysis comparing costs of transfusions at home versus hospital. However, preliminary data recently presented by our group indicate economic and QoL advantages of this model of care [30]. Other studies also, have previously indicated some economic advantages in this setting [29,30]. The major concern about “out-of-hospital transfusions” is represented by the distance from the hospital in case of severe reactions [18]. These concerns may negatively influence the patients’ attitudes regarding out-of-hospital blood transfusion [28]. Previous work, however, suggests that occurrence of clinical adverse reactions was very low, and our experience confirm this data [18,24]. We emphasize, that home transfusions are typically administered through stringent safety criteria by a careful patient’ selection and strict adherence to institutional guidelines and these might often be more stringent than those adopted in a hospital or in an outpatient setting. The main feature of our HC service is that of being a hospital-based team, closely working with a BTS that constantly support the activities of our team. Furthermore, patients were managed, in almost cases, by nurses and physicians usually working in
No need to travel to the hospital; no long waits for visits. Less distressing and more comfortable in the patient’s own home environment; closeness of loved ones. Less patient’s discomfort and energy expenditure; decreased infections. Potential for better QoL. Higher attention and better monitoring to single patient at home; potential for fewer transfusion errors and adverse reactions. Free for patients and families. The costs have been covered by the Public Health Care System and by a nonprofit organization. Potential for fewer days lost from work for family members. Time expensive for the team Distance from advanced medical service; full reanimation measures not immediately available in an emergent situation. Greater risk due to increased distance from hospital care and emergency services. National and local laws and regulations should be considered before to providing the transfusion service at home. More expensive for the health care agency?
our hematology unit, allowing a close integration between all services involved in all phases of the transfusion process. In addition, the commitment of an attending hematologist, which followed at home each single patient during the entire duration of the transfusion, had a decisive role in our experience. In this regard, some critical aspects of Italian law and regulation of transfusion practice should be clarified. Unlike other countries, where the nurse can infuse blood at home [18], according to Italian law health care regulations, only physicians can administer a blood transfusion. So in addition of prescribing and ordering blood transfusion, the physician should also directly perform the procedure under his/her responsibility. In this model, the nurse can cooperate and assist the physician in various phases of the transfusion process but he/she cannot perform the infusion of blood. Moreover, in our experience the transfusions were free of any charge for patients [29]. The latter represent an important practical aspect. In other health care systems, where patients should pay for transfusions, the cost at home is higher than for those given in an outpatient setting [28] and this concern may negatively influence the patient’s attitude regarding the choice to receive a domiciliary transfusion. In conclusion, our experience with domiciliary management of RBC transfusions was positive and our preliminary findings could form the basis for more analytic studies [30] focusing on the influence of a HC transfusion program on patient’s QoL and cost analysis. Funding source No financial support has been received for this work. Conflict of interest All authors have no conflicts of interest to declare. Acknowledgment None. Contributors. P.N. wrote the paper and gave substantial contributions to the conception and design of the study, acquisition, analysis and interpretation of data; A.T., M.G., M.M.T., L.C. M.P., L.S., G.A.B., A.P., B.N., F.E. and C.C. gave substantial contributions to the conception and design of the study, acquisition, analysis and interpretation
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of data, revising the article critically for important intellectual content; P.dF. and F.M. gave the final approval of the version to be submitted. References [1] Greenberg PL, Attar E, Bennett JM, Bloomfield CD, De Castro CM, Deeg HJ, et al. Myelodysplastic syndromes. J Natl Compr Canc Netw 2011;9(January (1)):30–56. [2] Williamson PJ, Kruger AR, Reynolds PJ, Hamblin TJ, Oscier DG. Establishing the incidence of myelodysplastic syndrome. Br J Haematol 1994;87(August (4)):743–5. [3] Stauder R, Nösslinger T, Pfeilstöcker M, Sperr WR, Wimazal F, Krieger O, et al. Impact of age and comorbidity in myelodysplastic syndromes. J Natl Compr Canc Netw 2008;6(October (9)):927–34. [4] Gupta P, LeRoy SC, Luikart SD, Bateman A, Morrison VA. Long-term blood product transfusion support for patients with myelodysplastic syndromes (MDS): cost analysis and complications. Leuk Res 1999;23(October (10)):953–9. [5] Caocci G, La Nasa G, Efficace F. Health-related quality of life and symptom assessment in patients with myelodysplastic syndromes. Expert Rev Hematol 2009;2(February (1)):69–80. [6] Pinchon DJ, Stanworth SJ, Dorée C, Brunskill S, Norfolk DR. Quality of life and use of red cell transfusion in patients with myelodysplastic syndromes. A systematic review. Am J Hematol 2009;84(October (10)):671–7. [7] Greenberg PL. Current therapeutic approaches for patients with myelodysplastic syndromes. Br J Haematol 2010;150(July (2)):131–43. [8] Greenberg PL, Attar E, Battiwalla M, Bennett JM, Bloomfield CD, DeCastro CM, et al. NCCN myelodysplastic syndromes panel. Myelodysplastic syndromes. J Natl Compr Canc Netw 2008;6(October (9)):902–26. [9] Santini V, Alessandrino PE, Angelucci E, Barosi G, Billio A, Di Maio M, et al. Italian Society of Hematology. Clinical management of myelodysplastic syndromes: update of SIE, SIES, GITMO practice guidelines. Leuk Res 2010;34(December (12)):1576–88. [10] Della Porta MG, Malcovati L, Strupp C, Ambaglio I, Kuendgen A, Zipperer E, et al. Risk stratification based on both disease status and extra-hematologic comorbidities in patients with myelodysplastic syndrome. Haematologica 2011;96(March (3)):441–9. [11] Naqvi K, Garcia-Manero G, Sardesai S, Oh J, Vigil CE, Pierce S, et al. Association of comorbidities with overall survival in myelodysplastic syndrome: development of a prognostic model. J Clin Oncol 2011;29(June (16)):2240–6. [12] Tendas A, Niscola P, Ales M, Baraldi L, Boschetto C, Caiazza E, et al. Disability and physical rehabilitation in patients with advanced hematological malignancies followed in a home care program. Support Care Cancer 2009;17(December (12)):1559–60. [13] Tendas A, Niscola P, Cinque R, Cupelli L, Giovannini M, Ales M, et al. Motor disability in malignant hematology: an epidemiological study on Italian hospitalized patients. Leuk Res 2010;34(February (2)):e66.
[14] Tendas A, Niscola P, Giovannini M, Scaramucci L, Cupelli L, Dentamaro T, et al. Epidemiology and pathogenesis of incident pain-related disability in malignant hematology: an Italian survey. Ann Hematol 2011;90(June (6)):719–20. [15] Ritchie EK, Lachs MS. Management of myelodysplastic syndromes in the geriatric patient. Curr Hematol Malig Rep 2009;4(January (1)):3–9. [16] Ria R, Moschetta M, Reale A, Mangialardi G, Castrovilli A, Vacca A, et al. Managing myelodysplastic symptoms in elderly patients. Clin Interv Aging 2009;4:413–23. [17] Ademokun A, Kaznica S, Deas S. Home blood transfusion: a necessary service development. Transfus Med 2005;15(June (3)):219–22. [18] Benson K. Home is where the heart is: do blood transfusions belong there too? Transfus Med Rev 2006;20(July (3)):218–29. [19] Havet N, Morelle M, Remonnay R, Carrere MO. Cancer patients’ willingness to pay for blood transfusions at home: results from a contingent valuation study in a French cancer network. Eur J Health Econ 2011. June 10 [Epub ahead of print]. [20] Niscola P, de Fabritiis P, Cartoni C, Romani C, Sorrentino F, Dentamaro T, et al. Home care management of patients affected by hematologic malignancies: a review. Haematologica 2006;91(November (11)):1523–9. [21] Alfieri P. Home blood and platelet transfusions as part of a domiciliary program of supportive care in patients with blood malignancies: an Italian single-centre experience. Haematologica 2008;93(Suppl. 2):172 [abs. 0430]. [22] Alfieri P, Ferrara L, Leonardi G, Luppi M, Marasca R, Torelli G, et al. Home care for unfit elderly patients with myelodysplastic syndromes: an Italian single-center experience. Haematologica 2009;94(Suppl. 2):49 [abs. 0127]. [23] Niscola P, Cartoni C, de Fabritiis P, Foà R, Mandelli F. Long term activity and ongoing development toward a new model of Home Care Organization in Rome: the ROMAIL-GIUSEPPE PAPA Home Hematological Hospital. Haematologica 2007;92:54a–5a. [24] Isaia G, Tibaldi V, Astengo M, Ladetto M, Marinello R, Bo M, et al. Home management of hematological patients requiring hospital admission. Arch Gerontol Geriatr 2010;51(November–December (3)):309–11. [25] Cartoni C, Niscola P, Breccia M, Brunetti G, D’Elia GM, Giovannini M, et al. Hemorrhagic complications in patients with advanced hematological malignancies followed at home: an Italian experience. Leuk Lymphoma 2009;50:387–91. [26] Fridey JL. Practical aspects of out-of-hospital transfusion. Am J Clin Pathol 1997;107(April (4 Suppl. 1)):S64–71. [27] Thompson HW, McKelvey J. Home blood transfusion therapy: a home health agency’s 5-year experience. Transfusion (Paris) 1995;35(May (5)):453. [28] Benson K, Balducci L, Milo KM, Heckel L, Lyman GH. Patients’ attitudes regarding out-of-hospital blood transfusion. Transfusion (Paris) 1996;36(February (2)):140–3. [29] Cartoni C, Brunetti GA, D’Elia GM, Breccia M, Niscola P, Marini MG, et al. Cost analysis of a domiciliary program of supportive and palliative care for patients with hematologic malignancies. Haematologica 2007;92(May (5)):666–73. [30] Cartoni C, Tendas A, Brunetti GA, Meloni E, Niscola P, Efficace F, et al. Hospital versus home care for patients with hematological malignancies in curative or terminal phase: cost analysis and cost-effectiveness study. Haematologica 2011;96(S3):2a.
Contents lists available at SciVerse ScienceDirect
Leukemia Research journal homepage: www.elsevier.com/locate/leukres
Transfusions at home in patients with myelodysplastic syndromes Pasquale Niscola a,∗ , Andrea Tendas a , Marco Giovannini a , Luca Cupelli a , Malgorzata Monika Trawinska a , Massimiliano Palombi a , Laura Scaramucci a , Gregorio Antonio Brunetti b , Alessio Perrotti a , Benedetta Neri a , Fabio Efficace c , Claudio Cartoni b , Paolo de Fabritiis a , Franco Mandelli d a
Hematology Unit, S. Eugenio Hospital, Rome, Italy Hematology, Department of Cellular Biotechnologies and Hematology, University “La Sapienza”, Rome, Italy Data Center and Health Outcomes Research Unit of the Italian Group for Adult Hematologic Diseases (GIMEMA), Rome, Italy d AIL (Italian Association Against Leukemias, Lymphomas and Myeloma), Rome, Italy b c
a r t i c l e
i n f o
Article history: Received 29 September 2011 Received in revised form 12 January 2012 Accepted 18 January 2012 Available online 14 February 2012 Keywords: Chronic anemia Frail patient Home care Managed care Myelodysplastic syndromes Transfusions at home
a b s t r a c t We report descriptive data of a home care (HC) program, throughout a 5-years period (2006–2010), focusing on the reliability and the safety of transfusions at home in 211 patients affected by myelodysplastic syndromes (MDS). Our results outline the potentially relevant role of a specifically dedicated HC service in the global management of frail MDS patients for which transfusions at home may represent a valuable option to maintain a good quality of life and avoid the possible discomfort due to hospital admissions and outpatient visits. © 2012 Elsevier Ltd. All rights reserved.
1. Introduction Myelodysplastic syndromes (MDS) are a heterogeneous group of bone marrow disorders [1] with a higher incidence in the elderly [1–3]. Chronic anemia is one of the main clinical features of MDS [1,4] and can greatly compromise patients’ quality of life (QoL) [5,6]. Although erytropoietic stimulating agents (ESAs) and novel agents may provide some clinical benefits and prolonged transfusion independence in many patients [1,7–9], regular administration of red blood cells (RBCs) concentrates continues to represent the only effective measure for most of the patients [7–9]. Appointments for medical visits, blood sample collections and transfusions, could thus represent an additional burden for these patients as they are typically provided on outpatient basis. Therefore, discomfort arising from driving distances and long waiting times in the hospital may often be important issues that could further complicate an optimal management of MDS patients and this might be particularly true for elderly patients, for those with medical comorbid
∗ Corresponding author at: Hematology Unit, S. Eugenio Hospital, Piazzale dell’Umanesimo 10, Rome 00144, Italy. Tel.: +39 0651002454; fax: +39 0651003245. E-mail address: [email protected] (P. Niscola). 0145-2126/$ – see front matter © 2012 Elsevier Ltd. All rights reserved. doi:10.1016/j.leukres.2012.01.010
conditions [10,11] or physical impairments [12–14] and social difficulties. Relying on family members or friends for travels to hospital for visits and transfusions, may also be an additional concern and stressful factor for some patients and their families [15,16]. The above mentioned issues illustrate how challenging could be, for some patients, to follow an outpatient care program on a regular basis. Hence, choice of the clinical setting in which RBCs transfusions can be administered could be a critical aspect of the management of MDS patients. In particular, for patients with higher risk MDS and a limited life expectancy or managed with palliative and supportive care, home care (HC) could represent, wherever possible, the most appropriate approach potentially helping patients maintain a good QoL [17–19]. Previous work has shown the potential role of HC in the global management of patients affected by hematological malignancies [20–25], for whom transfusion therapy is the most frequently provided domiciliary intervention [20,23]. This is particularly true for MDS patients with functional impairments [21–24]. In this paper we report the results from the experience of our hospital-based HC service throughout a 5-year period, describing patients’ characteristics, clinical indications, operating procedures and feasibility. We also focus on safety issues in the management of RBC transfusions in MDS patients at home.
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Table 1 Summary of home transfusion criteria adopted by our team. Inclusion criteria Patient and disease
Caregiver Home environment
Patient living in Rome or within the near urban area covered by our HC service. Disease-related chronic anemia refractory to all conventional measures, including ESAs. Physical limitations and/or compromised clinical and personal status. Social and family problems resulting in the impossibility to travel to the hospital and to attend clinical visits and transfusions. Stable medical conditions.a Adequate venous access. Informed and written consent. Responsible, capable and collaborating adult suitable at home. Other than a family member, caregiver would be also a friend or a home-aid assistant. Deemed adequate and suitable for a HC program. In particular, the home should be deemed easily accessible, clear, comfortable and safe to perform the transfusion. Availability of a functioning telephone.
Exclusion criteria Patient and disease
Caregiver Home environment
Patient’s refusal. Urgent transfusion in emergent clinical situations.a Inadequate vascular accesses. Sepsis.a Anemia due to underlying causes (hemolysis, active bleeding, iron and vitamins deficiency and so on) potentially resolvable by other measures (vitamins, iron, steroids, correction of a coagulation defect, surgery and so on) whenever applicable.a Positive indirect antiglobulin test (recipient serum – donors blood cross matching) and no antigen-negative donors RBCs units (both for autoantibodies and alloantibodies). Unresolved and/or undiagnosed fever, cardiovascular instability and/or others active clinical illnesses.a History of previous severe transfusion-related adverse reactions.a Patient living alone; no capable and responsible adult suitable as caregiver. Poor home conditions; home deemed unsafe and unsuitable for transfusion.
HC, home care; ESAs, erytropoietic stimulating agents; MDS, myelodysplastic syndromes; RBC, red blood cells. a For patients on a palliative care program, such as terminally ill patients, these criteria were considered on a case to case basis.
2. Patients and methods This retrospective study included 211 MDS followed up in a hematological HC program of St. Eugenio Hospital of Rome throughout a 5-year period (2006–2010). Patients have been admitted to hematological HC program. This HC program has been financially supported by the largest Italian Hematological Patient Association (i.e. the Roman Section of the Italian Association against Leukemias, Lymphomas and Myeloma, RomAIL) since 2006. Our staff is multidisciplinary and includes hematologists, nurses, psychologists, social workers and other health-care providers trained in hematology, palliative care and rehabilitation medicine [23,25]. The eligibility criteria for entering patients in the HC program are carefully assessed during an initial interview with the patient and the “designated” caregiver. The availability at home of a capable adult, as reliable caregiver, is the main inclusion criteria to allow patients entering the HC program. According to our working model, the caregiver, usually a member of the family is considered a key active player of our HC staff. In particular, the care giver is well informed and instructed, from the very beginning, about delayed transfusion-related reactions so as to allow him/her promptly identify adverse and relevant symptoms and inform our team. The patient’s informed consent is routinely obtained before the first home transfusion. A previous history of hospital transfusion is not considered an essential condition to take patients in the HC program. Written guidelines for the management of HC transfusion, of eventually occurring clinical complications, and criteria for the rapid admission of patients in case of severe adverse events, eventually unmanageable at home, have been developed and used as standard practice guidelines. The HC team closely works with general services and diagnostic structures of St Eugenio hospital. In particular a close relationship and collaboration with the blood transfusion service (BTS) of our hospital was established. Transfusion therapy is provided as part of a global HC program and is prescribed and supervised by our specialized and multidisciplinary trained staff basing on our institutional established transfusion criteria (Table 1) and operating model (Table 2) as well as in accordance with the Italian law, local regulation and previously reported guidelines on home transfusion [18,26,27]. The responsibility for home transfusion relies on the attending hematologist and on the nurse. The former evaluates the patient’s clinical status and the laboratory results. RBCs units are requested to the BTS of our hospital according to hemoglobin (Hb) levels (Hb < 8 g/dl) and/or to the clinical status and the symptom burden reported by the patient. In particular, a higher Hb threshold (Hb < 10 g/dl) is requested for patients with active cardiac and respiratory diseases. The attending hematologist assists the patient at home for all the duration of the transfusion and follows all aspects of the entire course of the HC program; moreover, all medications, such iron chelators, were given according to current practice guidelines for MDS [8,9]. The nurse is responsible for the maintenance of an adequate venous access, for the collection of blood samples for compatibility tests and for their safe transport in an adequate container to the BTS. Both the nurse and the hematologist are responsible to ensure
that drugs (such as adrenaline, chlorphenamine and hydrocortisone), materials and devices to handle any emergency are available at home before transfusions. Also all team members have to ensure the continuity of the therapeutic relationship with the patient and caregiver, reporting any delayed reactions by regular telephone contacts.
3. Results Overall, all 211 MDS patients were included in the HC program and received transfusions at home. Only 5 patients did not meet the inclusion criteria and were excluded from this HC program. Patient’s characteristics at the enrolment in the HC program are shown in Table 3. In general, the majority of patients had an adequate venous access and no long-term venous access by a central venous catheter (CVC) or long-line peripherally inserted central catheters (PICC) were requested as mandatory condition before the inclusion in the HC program; the temporary venous accesses to perform pretransfusion blood collection and the infusion of blood components were positioned and maintained by nurses or by physicians of our HC service for the time strictly necessary. Out of 211 patients, 174 (82%) were transfusion dependent at the start of the HC program. The remaining 37 (18%) failed ESAs and became transfusion-dependent during the HC program. At the enrolment to the HC program, median baseline Hb concentration was 8.3 (7.4–10.1) g/dl. Severe non-hematologic comorbidities were seen in 183/211 (87%) patients, with a median number of comorbid illnesses of 2 (0–6) per patient; cardiovascular and neurological diseases prevailed (Table 3). Median duration of HC was 9.2 (1–41) months. Among 211 patients, 37 (18%) patients received their first transfusion at home. Patients were followed at home for a median of 9.2 (1–41) months after the inclusion in the HC program. The median number of RBCs packages transfused for patient was 38 (range 1–162) for a total of 7766 units that were given in 4980 domiciliary transfusions. The median Hb level for which RBCs units were requested was 8.2 (range 6.9–9.8) g/dl. Nearly
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Table 2 Operating model of home transfusion. Tasks
Team member(s)
Comment
Decision making, refining indication to RBCs transfusion.
Hematologist
Definition of blood group. RBCs request to BTS.
Hematologist – Transfusionist (BTS) Hematologist
Pre-transfusion sample collection visit.
Nurse
Transport of blood samples to BTS for compatibility tests. Preparation of RBCs units and compatibility test.
Nurse
The common transfusion threshold adopted should be 8 g/dl; in individual patients with symptomatic anemia and in those with severe cardiorespiratory diseases, a higher transfusion threshold should be adopted. Blood group definition should be performed at entry. Maximum of two RBC units for each transfusion. In case of extremely severe anemia (Hb < 6 g/dl) a number of units greater than 2 could be requested by transfusing however separately with a break of more than 24 h. Blood sample for compatibility tests should be provided within 96 h prior the expected date of the transfusion; after 96 h, a new sample is required. A safe transport container should be used.
Positioning and maintenance of venous access.
Nurse
Transport of RBCs units from the BTS to patient’s home. Administration of transfusion (each RBC unit should be transfused in 1.5–2.0 h at a rate of 3 mL per minute; not plus than 2 RBC units for each transfusion).
Hematologist or caregiver Hematologist with or without the assistance of a nurse.
Patient’s surveillance and monitoring.
Hematologist
Collection of all transfusion-related wastes and its return to the hospital. Seeking the medical attention in case of emerging symptoms potentially referable to delayed transfusion-related adverse reactions. Call the patient 24 h after the transfusion.
Hematologist
Transfusionist (BTS)
Caregiver, Hematologist
Full compatible and leukoreduced blood components should be used. Saline-washed or irradiated RBCs units should be used where indicated and requested. According to the patient’s clinical needs, pooled platelet concentrates, single-donor platelet aphaeresis and fresh frozen plasma can be also requested and infused at home. According to the patient’s preference and the status and the availability of venous accesses, a needle-cannula would be placed by the nurse at the time of the pretransfusion blood collection and then maintained until the transfusion. A safe and refrigerated transport container should be used. Major drugs, materials and devices for the treatment of any adverse reactions (such as adrenaline, chlorphenamine and hydrocortisone) should be present at home before the start of the transfusion. At least one capable adult designated as caregiver should be present for all the duration of transfusion. All the duration of transfusion and at least 30 min after the end of the procedure. A safe and appropriate disposal should be guaranteed. The care giver should be appropriately informed and instructed about delayed transfusion-related reactions to allow prompt symptom identification and communication. Regular telephone contacts are recommended to ensure the continuity of the therapeutic relationship with the patient and to support the caregiver and record any delayed reactions not yet communicated.
Nurse or hematologist
RBC, red blood cells; BTS, blood transfusion service.
all transfusions were safely administered at home without any serious adverse effect (Table 4). Mild complications, such as mild allergic, urticarial and febrile non-hemolytic transfusion reactions occurred in 12 (0.0024%) of 4980 domiciliary for transfusions and were observed in 11 (5.2%) of 211 patients (Table 4). However, all complications were managed at home and no hospital admissions due to home transfusions were recorded. No particularly difficult venous access were recorded; only 4 (2%) of 211 patients had a CVC at the time of the inclusion in the HC program. Thereafter, during the HC program, additional eight (4%) patients required hospital admission because of the need of a PICC or a CVC. HC service
Table 4 Home transfusion (4980 transfusionsa ): clinical complications. Adverse reactionsb
Table 3 Patient’s characteristics. Age Sex Median baseline Hb level Physical disability
Comobidities
and transfusion at home were highly appreciated by patients and their families. No complaints or withholding from the HC program on patient’s request were recorded. Disease evolution into acute myeloid leukemia (AML) occurred at home in 59 (28%) out of 211 cases; hydroxycarbamide was administrated with palliative intent, given the compromised clinical status of affected individuals, none of them being eligible to receive intensive chemotherapy or other disease-modifying treatments.
Cardiovascular Neurological Diabetes Associated cancer Pulmonary Kidney Peptic Ulcer Liver
85 years (69–98) 85 male, 126 female 8.3 (7.4–10.1) 162/211 (77%) 64/211 (30%) 48/211 (23%) 41/211 (20%) 29/211 (14%) 25/211 (12%) 23/211 (11%) 22/211 (10%) 13/211 (6%)
Extravasations/vascular access related hematoma Fever (>38 ◦ C) Cardiorespiratory symptoms (fluid overload and others complications) Skin rash Nausea and vomiting Total
Number of complication events (%) 6 (0.0012) 2 (0.0004) 2 (0.0004)
1 (0.0002) 1 (0.0002) 12 (0.0024)
a A maximum of 2 red blood cell units have been administered for each transfusion. b All adverse reactions were managed at home; a rapid resolution and an uncomplicated outcome were observed in all cases.
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Table 5 Advantages and disadvantages of transfusion at home compared to hospital. Advantages
Logistic Psychological Medical QoL Safety and liability
Costs
Social and Economic Disadvantages
Logistic and organizational Medical
Safety and liability Regulatory and legal concerns
Costs
4. Discussion In our hematological department, a HC program, financially supported by a national Patient Association (AIL), was implemented with the aim of managing frail hematological patients outside the traditional in-hospital model of care. An additional aim in setting up this program was that of improving QoL for patients and their families and to optimize the use health economic resources [23,28–30]. The development of alternatives to hospitalization for MDS patients raises the question of the safety and the feasibility of home blood transfusion, which may be indicated under specific conditions (Table 1). On the basis of our data and on the ground of current knowledge in this area [18,24], pro and cons of blood transfusions at home are summarized in Table 5. According to our experience, RBC transfusions at home were feasible, reliable, effective and well accepted by older MDS patients, avoiding personal and family’s distress and possible social and economic costs due to travels to hospital. The main limitation of the present report is that not providing quantitative on patients’ QoL, as we did not implement a formal QoL assessment for these patients. We are currently implementing such patient-reported QoL outcomes to provide evidence base data on the value of our approach. Also, we cannot draw conclusions on cost as we did not perform a cost analysis comparing costs of transfusions at home versus hospital. However, preliminary data recently presented by our group indicate economic and QoL advantages of this model of care [30]. Other studies also, have previously indicated some economic advantages in this setting [29,30]. The major concern about “out-of-hospital transfusions” is represented by the distance from the hospital in case of severe reactions [18]. These concerns may negatively influence the patients’ attitudes regarding out-of-hospital blood transfusion [28]. Previous work, however, suggests that occurrence of clinical adverse reactions was very low, and our experience confirm this data [18,24]. We emphasize, that home transfusions are typically administered through stringent safety criteria by a careful patient’ selection and strict adherence to institutional guidelines and these might often be more stringent than those adopted in a hospital or in an outpatient setting. The main feature of our HC service is that of being a hospital-based team, closely working with a BTS that constantly support the activities of our team. Furthermore, patients were managed, in almost cases, by nurses and physicians usually working in
No need to travel to the hospital; no long waits for visits. Less distressing and more comfortable in the patient’s own home environment; closeness of loved ones. Less patient’s discomfort and energy expenditure; decreased infections. Potential for better QoL. Higher attention and better monitoring to single patient at home; potential for fewer transfusion errors and adverse reactions. Free for patients and families. The costs have been covered by the Public Health Care System and by a nonprofit organization. Potential for fewer days lost from work for family members. Time expensive for the team Distance from advanced medical service; full reanimation measures not immediately available in an emergent situation. Greater risk due to increased distance from hospital care and emergency services. National and local laws and regulations should be considered before to providing the transfusion service at home. More expensive for the health care agency?
our hematology unit, allowing a close integration between all services involved in all phases of the transfusion process. In addition, the commitment of an attending hematologist, which followed at home each single patient during the entire duration of the transfusion, had a decisive role in our experience. In this regard, some critical aspects of Italian law and regulation of transfusion practice should be clarified. Unlike other countries, where the nurse can infuse blood at home [18], according to Italian law health care regulations, only physicians can administer a blood transfusion. So in addition of prescribing and ordering blood transfusion, the physician should also directly perform the procedure under his/her responsibility. In this model, the nurse can cooperate and assist the physician in various phases of the transfusion process but he/she cannot perform the infusion of blood. Moreover, in our experience the transfusions were free of any charge for patients [29]. The latter represent an important practical aspect. In other health care systems, where patients should pay for transfusions, the cost at home is higher than for those given in an outpatient setting [28] and this concern may negatively influence the patient’s attitude regarding the choice to receive a domiciliary transfusion. In conclusion, our experience with domiciliary management of RBC transfusions was positive and our preliminary findings could form the basis for more analytic studies [30] focusing on the influence of a HC transfusion program on patient’s QoL and cost analysis. Funding source No financial support has been received for this work. Conflict of interest All authors have no conflicts of interest to declare. Acknowledgment None. Contributors. P.N. wrote the paper and gave substantial contributions to the conception and design of the study, acquisition, analysis and interpretation of data; A.T., M.G., M.M.T., L.C. M.P., L.S., G.A.B., A.P., B.N., F.E. and C.C. gave substantial contributions to the conception and design of the study, acquisition, analysis and interpretation
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