Introduction
Immunoglobulin replacement therapy is a common treatment for patients affected with various immunologic deficiency syndromes. It aims to increase the serum immunoglobulin G (IgG) level to normal physiologic concentrations and to protect against bacterial infections [
1]. In addition, Ig therapy is used for immune modulation in several auto-immune and neurological conditions. Ig therapy can be provided in a hospital or, if well tolerated, at home. The administration mode is either intravenously (IVIg) or subcutaneously (SCIg). Both modes of administering IgG have been demonstrated to provide adequate protection from infections and are well tolerated [
2]. Each mode has its strengths and weaknesses, and the choice of administration mode depends on a shared decision-making process where physician’s judgment, patient’s preferences, medical or individual needs, and sometimes the insurance coverage are taken into account [
3‐
5].
Treatment with Ig has a positive effect on the health-related quality of life (HRQoL) of patients with immunologic deficiency syndromes [
1,
6]. Nevertheless, the treatment scheme is often intensive and burdensome and may be required chronically. The Ig must constantly be replenished at specific intervals, depending on individual needs and mode of administration. Whereas IVIg is generally administered in relatively large volumes once every 3–4 weeks, SCIg is given in smaller more frequent doses, for example, once or twice a week. Patients switching from IVIg replacement therapy in the hospital or doctor’s office to home-based SCIg administration showed strong improvements in HRQoL [
7‐
11]. They not only felt more energetic, but they also reported increased emotional and social well-being and less restrictions on daily activities such as work and school. Furthermore, the introduction of home-based Ig therapy has shown to increase treatment satisfaction. Home treatment with SCIg is evaluated as more convenient, comfortable, and flexible and leads to greater independence in patients than hospital-based treatment with IVIg [
9,
12].
In most countries, home-based Ig treatment is given solely subcutaneously. In Europe, aside from the UK, Sweden, France, and the Netherlands [
13,
14], home-based intravenous infusion with Ig is still uncommon. Consequently, previous research on home-based Ig therapy predominantly focused on subcutaneous home treatment, often compared to intravenous treatment in hospitals. Literature on the effects of intravenous home treatment is scarce, and the few available studies are dated or concerned small numbers of patients with specific indications [
15‐
17]. Hence, a complete and thorough evaluation of user experiences and effects of home-based therapy for both administration modes is lacking. Moreover, previous studies on home-based Ig treatment have not taken into account both the patients’ and healthcare professionals’ perspectives. As the choice of location and mode of administration is based on shared decision-making of patients and healthcare professionals, an in-depth evaluation of the home treatment from different perspectives is of great importance. Therefore, the aim of this study is to evaluate home-based Ig treatment by assessing and comparing user experiences and the perceived value of home treatment for both patients and healthcare professionals, and to study potential differences between subcutaneous and intravenous modes of administration.
This study presents an evaluation of home treatment with IgG in the Netherlands. Although the majority of patients with immunologic deficiency syndromes is treated within a hospital setting (i.e., standard care), there is a rising number of patients in the Netherlands switching to home therapy after first receiving IgG treatment in the hospital. Currently, there are five service providers for home therapy with IgG in the Netherlands, and the Sanquin Home Service (SHS) is one of them. SHS operates independently and the service is not limited to specific plasma product brands. This service aims to provide personalized care at home to patients who receive immunoglobulin therapy by offering a variety of different schemes for home-based treatment, including subcutaneous and intravenous treatment and ranging from home-based infusion of Ig by a qualified nurse to guidance of patients and informal caregivers in the self-administration. Patients are referred to home-based treatment by the physician in the hospital, after the patient, informal caregiver(s), and physician together have decided that this treatment option is safe and appropriate given the medical and individual needs of the patients. The hospital-based physician remains responsible for the patient at all time and is kept informed by means of a web-based reporting system. In general, patients with SCIg treatment are trained by SHS nurses to self-administer and continue treatment by themselves after approximately three supported sessions. Patients with IVIg treatment receive permanent assistance in administering IgG, either from a nurse or an informal caregiver. Though the venipuncture is generally performed by the nurse, some patients are trained to execute specific steps in the procedure (e.g., removing the needle afterwards, programming the infusion pump). In all cases, SHS nurses are available as backup when needed.
This study offers an exceptional opportunity to compare both administration modes (SCIg and IVIg) in the home setting with the regular treatment (IVIg) in hospitals, and to evaluate the home treatment from the perspectives of all persons involved (i.e., patients, informal caregivers, and healthcare professionals).
Methods
Study Design and Population
Patients or their informal caregivers (i.e., parents, spouses) and healthcare professionals of the SHS filled in an online survey. All patients who recently or previously have been treated with immunoglobulins by the home service provider (in 2014–2015, or in the case of (ex) pregnant women, in the past 5 years) were approached for participation. Also, hospital professionals who prescribe home-based treatment to patients (specialists and specialized nurses) and the professionals involved in performing the treatment at home (qualified nurses) were asked to participate.
Patients and informal caregivers (n = 656) were invited to participate in the study by the pharmacy (Mediq) and healthcare professionals by SHS. They were contacted by letter with a request to register for the study through an online or written registration form. After registration, they received a personal e-mail with a link to an online questionnaire. Healthcare professionals (n = 156) were invited per e-mail by SHS to participate in the survey. Potential respondents received two reminders for completing the questionnaire, 2 and 4 weeks after the first request. Informed consent was obtained from all individual participants included in the study.
Questionnaires
Two questionnaires were developed (in Dutch): one for patients and their informal caregivers, and another for healthcare professionals [
18]. Draft versions of the questionnaires were based on focus group discussions and interviews with patients, informal caregivers, and healthcare professionals. In addition, we used literature and other relevant questionnaires as example. The questionnaires were pre-tested in 21 cognitive interviews with 11 patients and 10 professionals to evaluate the clarity and content validity of the questions [
19], and the questionnaires were adjusted accordingly (see Appendices
1 and
2 for the final questionnaires (translated into English)).
The questionnaire for patients and informal caregivers consisted of 155 questions and two overall ratings concerning the home-based service and hospital care (i.e., global rating and recommendation score). The questionnaire for healthcare professionals consisted of 90 questions and overall ratings. An overview of all constructed scales, from both questionnaires, can be found in Appendix
3 (see also “
Statistical Analysis”).
The global ratings concerning the home-based service and hospital care (addressed in both questionnaires) had answering scales from 0 (worst possible care) to 10 (best possible care). Recommendation scores assessed the probability of recommending the service to others (0 = not at all; 10 = very likely) [
20]. And the fear of needles was measured with an 11-point scale ranging from 0 (no fear at all) to 10 (extremely anxious). All other questions were positively formulated propositions, with a 5-point answering scale: (− 2) completely disagree, (− 1) partly disagree, (0) agree nor disagree, (1) partly agree, (2) completely agree. We chose a default of positively formulated questions, as this best resembled the experiences reported in the focus groups and interviews on which the questionnaires were based.
Statistical Analysis
Data were analyzed by using Stata, version 14.1. First, psychometric analysis was conducted to assess the dimensional structure of the questionnaires (see Appendix
3 for the 20 constructed scales, their underlying items, and internal consistency (Cronbach’s alpha)). Secondly, scores were calculated for each questionnaire and response group, either based on separate items or on reliable scales (alpha ≥ 0.70). Two scales for the comparison of the perspectives of clients and professionals showed moderate reliability (accessibility and communication: alpha = 0.61; perceived benefits of SHS: alpha = 0.58), but were included for descriptive purposes.
Differences in experiences and overall ratings between patients, informal caregivers, and the two types of healthcare professionals were examined with analysis of variance and consecutive post hoc tests. In addition, potential differences between patients with various administration modes (SC or IV) were examined by analysis of variance with correction for differences in the patients’ gender and age. A p value of < 0.05 was used as limit for statistical significance.
To compare the perspective of clients and healthcare professionals, similar items from the two questionnaires were used to compute comparable scale scores (see Appendix
3 (bottom part) for the five scales regarding the various perspectives on experiences, perceived benefits, and effects of home treatment). In the comparative analysis, the two types of healthcare professionals (SHS nurses and hospital professionals) are regarded as separate groups.
Discussion
This study assessed the patients’ and professionals’ perspective on the home treatment with subcutaneous or intravenous immunoglobulin replacement therapy by the Sanquin Home Service. The positive results of this evaluation suggest that the home treatment of SHS is highly personalized, effective, and well adapted to the needs and preferences of the target group. Both patients and professionals are predominantly positive about the SHS and highly appreciate the home-based treatment. Clients value the home treatment with a global rating of 8.84 on a scale from 0 to 10, nearly one point higher than their appraisal of the hospital-based treatment with Ig (7.85). Healthcare professionals value the SHS with an overall rating of 8.32.
The treatment at home enables and encourages the autonomy and participation of patients in daily life and contributes to their health. This applies both to subcutaneous and intravenous modes of home treatment, as nearly no differences were found in experiences and ratings of patients with these two administration modes. However, patients by whom the Ig is administered subcutaneously are more positive about the accessibility and communication of the SHS staff (nurses and coordinators) than patients receiving the Ig intravenously. As this latter patient group is more dependent on the SHS nurses in receiving their Ig product, it is likely that they are more critical towards the accessibility and communication with the SHS staff because these aspects are especially important to them.
Furthermore, patients and informal caregivers reported less positive experiences with the start of the SHS, regarding the practice sessions and the administration of Ig, than professionals did. It is likely that unfamiliarity with the procedures at the start of the home-based treatment explains this result. Similarly, unfamiliarity also seems to play a role in the fear of needles, as this appears to be higher when injected by a substitute or random nurse at home or in the hospital, and this fear was the lowest when injected by the usual and well-known SHS nurse (see Fig.
2). It can be assumed that the location of treatment may have a certain impact as patients are more likely to feel comfortable in their own environment and this may influence their perceived level of anxiety. In addition, the administration mode also seems to be related to the fear of needles, as patients receiving IVIg reported less fear than patients receiving SCIg. Because of the quasi-experimental and non-randomized design of this study, we cannot offer certainty about cause or effect; a fear of needles may very well affect the choice of administration mode, but also could be a consequence of it.
Finally, this study revealed a discrepancy between the perspectives of clients and hospital professionals, showing that the professionals gave a lower global evaluation of the home-based service and rated the effects of the service on the quality of life lower than patients.
Strengths and Limitations of This Study
The study provides insight into the practice of home treatment with immunoglobulin, being one of the first to evaluate both subcutaneous as intravenous home treatment and taking into account the different perspectives of both patients and professionals. The results presented are in line with a substantial number of earlier findings displaying the positive evaluation of home-based treatment with SCIg and/or IVIg [
7‐
11,
15,
16]. Nonetheless, a number of possible limitations should be considered when interpreting the results of this study.
Firstly, this study assesses home-based treatment with immunoglobulin of solely one provider (out of five) in the Netherlands, which may raise questions concerning the objectivity of the professional respondents. However, these professionals are not employed by SHS, as the home service relies on a national network of authorized and independent nurses from (local) home care organizations, and the hospital-based professionals work together with but are not in service of the SHS. Furthermore, the SHS nurses are not personally known to the physicians in the hospitals, and the nurses were not asked to rate their own performance.
Secondly, this study solely included clients who currently or recently received treatment by the SHS, and has no comparator group. Although this study also enrolled patients who recently stopped the home-based treatment, or who switched back to hospital treatment, we were not able to further analyze the experiences of these particular respondents due to the small number (n = 17).
In addition, the response to both questionnaires was only moderately high; 38% of the clients and 41% of the professionals responded to the survey. Though these percentages are common in healthcare evaluation surveys, it raises questions regarding the representativeness of this study. Nevertheless, non-response analyses showed no major differences between the characteristics of the client group invited to participate and the final respondents. Unfortunately, nothing is known about the representativeness of the professional respondents, as background characteristics of the non-responding professionals were not available. The relatively low response rate of the hospital professionals, with only about one third of the invited professionals who actually responded (vs. 69% of the SHS nurses), possibly reflects a lower level of involvement of hospital professionals with the SHS. However, as it is unclear how many of the professionals actually received and opened the e-mail with the invitation to fill out the questionnaire, this response rate is rather a lower bound.
Recommendations
Home treatment seems suitable to and is almost equally preferred by patients receiving SCIg or IVIg therapy. However, the differences found in this study regarding the experiences with SCIg and IVIg home-based therapy illustrate the importance of keeping a close focus on the treatment procedures, which are different for the two administration modes. It is advisable to keep this distinction salient in future research to further optimize home-based treatment for both patient groups. Also, we recommend further research into the needs and experiences of the different patient groups who receive home-based treatment with IgG. Because the neurologic and immunological indications are likely to result in different needs, with some conditions requiring only temporary IgG therapy while others may deteriorate in due course, the HRQoL and needs regarding home treatment may be impacted differently. Moreover, instead of asking patients to compare their views on treatment at home with their (prior) treatment in hospital, it may be more informative to compare the responses of two groups of patients: those who currently receive home treatment and those who continue to receive or who switched back to treatment in hospital. Future research among both patient groups (outbound and home treatment) should thus reveal actual differences in patient experiences in the two settings.
Switching to home treatment will expose patients to a certain degree of unfamiliarity and newness. Results of this study show that this is particularly true for the experiences with practice sessions and the administration of Ig. With proper guidance at the start of the home treatment and sufficient practice sessions of administration, the Ig product might accelerate the transition to a point where clients feel accustomed and at ease with home-based treatment. To ensure a smooth transfer to home-based treatment, the use of a hospital-based transfer team, with dedicated nurses who are familiar with IgG treatment and the organizations providing home treatment, could be helpful.
This study focused at different perspectives of all persons involved, as the decision on whether to receive home- or hospital-based Ig therapy is ultimately based on the shared decision-making of patients, informal caregivers, and healthcare professionals. Because of the discrepancy found between the patients’ and professionals’ perspectives, and given the key role of the hospital professionals in providing reliable information to (potential) patients, it is recommended to better inform these professionals about the actual effects of home-based treatment on the patients’ quality of life. Thus, enabling them to provide more reliable patient information, in order to optimize the process of shared decision-making regarding the location and administration mode of Ig therapy.
Compliance with Ethical Standards
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