Optimizing Subcutaneous Immunoglobulin Therapy: A Modified Delphi Study on Supply Management and Best Practices in the U.S. Health Care System
Devin Wall, RN KORU Medical Systems dwall@korumedical.com
Elizabeth M. Younger, CRNP, PhD Johns Hopkins University School of Medicine
Kelvin Shaw, MD Allergy and ENT Associates
Chris Pratt, PharmD CVS
Suzanne Strasters, FNP-C GC Biopharma
Sam Mihelich, PharmD NuFactor Specialty Pharmacy
Will Holland, PharmD Realo Specialty Care Sarah
Taylor, RN Realo Specialty Care
Kolleen Casey, BSN KH Nursing Services
Nicole Graves, RN RxCrossroads
Abstract
Introduction
Subcutaneous immune globulin (SCIG) therapy is a flexible, patient-centered alternative to intravenous immune globulin (IVIG). While increasingly popular in home and specialty infusion care, managing the ancillary supplies for SCIG therapy remains complex. Current literature offers general guidance on SCIG administration but lacks detailed consensus on best practices for supply management, infusion site selection, and training requirements. This gap contributes to variability in practice and challenges for both patients and providers. The purpose of this Delphi study was to leverage multidisciplinary expertise to identify consensus in SCIG supply management, aiming to inform best practices, improve care consistency, and support the growing demand for SCIG therapy in home-based settings.
Methods
Nine multidisciplinary experts were recruited, representing prescribing providers, pharmacists, and infusion nurses with either recent or extensive experience in supporting, managing, or administering SCIG therapy in the clinical setting. The study consisted of multiple Delphi rounds. In the first round, participants answered 10 open-ended questions about best practices for ancillary supply management for patients receiving SCIG therapy. For the second Delphi round, responses and statements collected during the first round were categorized by theme and organized into forced-choice scale (77 items), ranked response (3 items), and rated response (20 items) questionnaire items. Participants reviewed, commented on, and ranked responses to identify consensus and areas of controversy. Participants were given the opportunity to clarify responses, achieve greater understanding, and explore opportunities for future research during optional individual interviews during a third and final Delphi round. Four out of the 9 original panelists opted to participate in individual interviews. The results of Delphi rounds were de-identified, clustered, and compared with existing literature surrounding best practices for SCIG infusion.
Results
The Delphi process identified several key findings: individualized approaches to needle selection, infusion site management, and flow rate adjustments are critical for minimizing adverse reactions and optimizing patient comfort. Additionally, the ease of use of infusion systems significantly impacts patient adherence and the need for clinical support, while ongoing education and follow-up are essential for addressing infusion-related challenges. The study also highlighted the importance of interdisciplinary collaboration and cost considerations in ensuring effective and patient-centered SCIG therapy delivery.
Consensus Areas:
Consensus emerged among the 9 participants within the domains of shared decision-making, selecting needle length and infusion site locations based on individual anatomical variation rather than bodyweight alone, and prioritizing patient-centered approaches (Somewhat Agree 11.1%; Agree up to 44.4%; Strongly Agree 56%). A simple infusion system with fewer steps was preferred over complex systems due to reduced training and education demands (Somewhat Agree 11.1%; Agree 55.6%; Strongly Agree 22.2%).
Disciplinary Variations:
Different priorities were noted across the disciplines of nursing, pharmacy, and prescribing providers, particularly in achieving optimal infusion rates for patients. These variations primarily emerged in the ordered response items, with Kendall’s W values between 0.24 and 0.38.
Conclusions
The study’s emphasis on individualized infusion practices and simplified systems aligns with the broader health care trend toward patient-centric approaches and home-based care. By establishing expert consensus and addressing gaps in current practices, the findings support the development of clearer guidelines and future innovations.
Introduction
Subcutaneous immune globulin (SCIG) therapy has emerged as an effective and patient-centered alternative to intravenous immune globulin (IVIG) for individuals requiring longterm immune globulin replacement. Traditionally, IVIG has been the primary route of administration; however, the complexity of venous access, patient discomfort, systemic side effects, and the demand for flexible, home-based therapies have driven the adoption of SCIG. SCIG allows for self-administration and improved treatment adherence, yet challenges persist, including variability in clinical practices, inconsistent equipment selection, and limited interdisciplinary collaboration.1-6 For vulnerable populations, such as the pediatric population, older adults, or those with mobility limitations, these challenges may exacerbate barriers to therapy and lead to suboptimal outcomes.6,7 This growing complexity necessitates a better understanding of the clinical, systemic, and patient-centered factors influencing SCIG therapy delivery.
Despite its advantages, SCIG therapy remains hindered by fragmented care delivery models and gaps in evidence-based practice guidelines.8,9 Current approaches to equipment selection, infusion site management, and patient education may be inconsistent and driven by institutional or health care provider preferences rather than standardized protocols.10,11 Specialty pharmacies and manufacturers frequently dictate the provision of supplies, with limited input from clinicians and patients, creating variability in the infusion experience. In some cases, clinicians may have inadequate training to guide patients in customizing their therapy to maximize comfort and adherence.
Objectives
- The objectives of the study were to:
- Identify areas of consensus and controversy on best practices in SCIG therapy, focusing on (a) infusion site selection and needle placement, (b) equipment use and troubleshooting, and (c) patient and caregiver education.
- Identify barriers to interdisciplinary collaboration in the delivery of SCIG therapy and inform strategies to enhance communication and decision-making among stakeholders.
- Prioritize innovations in equipment design and patient training to address challenges faced by patients with physical or cognitive limitations.
- Synthesize expert recommendations into a framework that promotes standardized, patient-centered care practices while allowing flexibility for individual needs.
This research aims to further inform the development of evidence-based practice guidelines for SCIG therapy, ensuring consistent, high-quality care for patients in both clinical and home-based settings. By addressing gaps in education, equipment usability, and interdisciplinary communication, the study seeks to optimize SCIG therapy outcomes and encourage broader adoption of this treatment modality.
Scope
The scope of this Delphi study encompasses SCIG therapy supply management practices for treatment in diverse patient populations and various infusion settings. Guided by the research question, “What are the best practice recommendations for the delivery, education, and interdisciplinary management of SCIG therapy supplies?” this study seeks to inform strategic approaches to improve patient outcomes, enhance safety, and standardize care. The study focuses on key aspects of SCIG therapy, including infusion site selection, equipment use, patient and caregiver education, and interdisciplinary collaboration.
Methods
Study Design
This study employed a 3-step modified Delphi method to identify areas of consensus and controversy on best practices in the administration of SCIG therapy. The Delphi method, well-suited for gathering expert opinions in a systematic and iterative process, was conducted electronically to accommodate geographically dispersed participants and ensure a transparent, structured approach to data collection and analysis.12
The Delphi process included qualitative and quantitative elements, allowing for both thematic exploration and prioritization of key issues. Participants included a multidisciplinary panel of pharmacists, infusion nurses, and prescribing providers, selected for their expertise and diverse practice settings. The iterative rounds were designed to identify and refine consensus on topics such as infusion site selection, equipment use, patient education, and interdisciplinary collaboration. This approach was chosen because it facilitates collective decision-making on complex issues that are not easily resolved through conventional analytical techniques but benefit from subjective judgments across specialties. The findings are intended to inform standardized, evidence-based recommendations that can be applied across clinical and home-based care settings.
Participants
The expert panel for this Delphi study was selected to ensure multidisciplinary representation, clinical expertise in SCIG therapy, and diversity in practice settings (Table 1). Participants included pharmacists, infusion nurses, and prescribing providers, all actively involved in the delivery or management of SCIG therapy in various infusion settings. To incorporate perspectives from key stakeholders, individuals were recruited through professional networks, academic affiliations, and referrals from relevant associations across the United States. Invitations were sent via email, accompanied by participant information and consent forms. Participants identified their disciplines from a prepopulated list which included the roles of Prescribing Provider, Pharmacist, Infusion Nurse, Case Manager, Nurse Navigator, Patient Advocate, or Other, in which case the respondent was able to self-identify their role in a free text field.
Inclusion criteria required participants to have: (a) recent (within 6 months) clinical experience prescribing, administering, or managing SCIG therapy, and/or (b) evidence of professional contributions, such as peer-reviewed publications, participation in scientific symposia, or teaching roles within this field. The aim was to recruit a panel of 6 to 10 experts, balancing representation from prescribers, pharmacists, and nurses to ensure a comprehensive range of perspectives. Recruitment relied on purposive and snowball sampling, targeting clinicians recognized as thought leaders or highly experienced in SCIG therapy. As this study prioritized health care professional perspectives, patients and the public were not directly involved in the design, conduct, or dissemination of this research.
Study Procedures
The initial open-ended questionnaire for this Delphi study was developed by a multidisciplinary research committee consisting of an infusion clinical specialist, a product development specialist, an epidemiologist, and a health economist. This committee drew on evidence from stakeholder interviews, a review of clinical guidelines (e.g., the Infusion Therapy Standards of Practice), and grey literature to ensure the framework was comprehensive and aligned with current practices and challenges in SCIG therapy. The research committee aimed to create a robust framework that addressed critical domains of supply characteristics, infusion site reaction mitigation, ease of use, SCIG administration, education and training, future research and innovation, cost considerations, and communication.
e-Delphi Survey Rounds
The study was conducted in iterative rounds. In the first round, an open-ended questionnaire invited the 9 participants to share their perspectives on challenges and best practices in SCIG therapy. The responses were thematically analyzed to generate key variables and structured response options for subsequent rounds. Open-ended survey responses were analyzed to capture qualitative insights to inform the development of closed-ended questions for the same 9 participants in the second round, allowing the panel to prioritize and refine recommendations, guidelines, and principles systematically. Thematic analysis was used to process and categorize the open-ended responses. The research team reviewed participant responses to identify recurring themes, patterns, and perspectives related to best practices for SCIG therapy and supply management. Responses were systematically coded into the categories of supply characteristics, infusion site reaction mitigation, ease of use, optimizing the infusion experience, supply availability, SCIG administration, training and education, new technologies, cost considerations, and communication. This qualitative feedback was integrated into the study design for subsequent rounds of the Delphi process. Additionally, the researchers integrated qualitative insights with the quantitative data to address discrepancies in consensus levels, refine the phrasing of areas of consensus or controversy, and introduce new items based on participant input. This structured and evidence-informed process ensured a rigorous approach to informing best practices in SCIG therapy supply management. Both survey rounds were administered electronically using Microsoft Forms to facilitate participation by geographically dispersed panel members. The first-round survey consisted of 10 open-ended questions (Table 2) designed to generate structured responses in the second-round survey (Supplementary, Appendix A). The second-round survey was divided into 8 sections corresponding to the coded themes identified during the first-round survey, reflecting key domains of SCIG therapy supply management: (a) supply characteristics, (b) infusion site reaction mitigation, (c) ease of use, (d) SCIG administration, (e) education and training, (f) future research and innovation, (g) cost considerations, and (h) communication. (Supplementary, Appendix B) Each survey contained embedded instructions and participation guidelines. Members of the expert panel were invited to participate via a web link sent to their provided email addresses.
During the second-round survey, panelists were asked to rate their agreement or assessment of each proposed practice recommendation, guideline, or principle. These responses were in the form of ratings using a 6-point forced-choice scale, a 10-point clinical impact scale, and ordered responses. Forced-choice scale items in this Delphi study were used to quantify levels of agreement with proposed statements related to SCIG therapy and supply management. The use of forced-choice response items instead of traditional Likert scales minimized the potential for response biases such as social desirability and acquiescence. Forced-choice formats require respondents to select options corresponding to the level of agreement or disagreement with a concept, topic, or practice without the ability to select a neutral option, thereby reducing the tendency to select socially desirable or indifferent responses, which is more common in Likert-type scales. Respondents may also tend to default to the middle option in longer surveys out of convenience or fatigue in a conscious or unconscious attempt to reduce the cognitive effort required to make a decision. Additionally, forced-choice items are advantageous in contexts where distinguishing the relative importance of various clinical practices is crucial, as they compel participants to prioritize specific practices over others, yielding clearer insights into expert consensus. By using this method, the study ensured a more nuanced and reliable assessment of expert priorities and preferences in clinical decision-making.13 These items were used to allow the researchers to measure the degree of positive or negative consensus on each statement abstracted from the round 1 survey. Response options included “strongly disagree” (0), “disagree” (1), “somewhat disagree” (2), “somewhat agree” (3), “agree” (4), “strongly agree” (5), and “I don’t know” (no score). The forced-choice scale responses were analyzed using median, mean, and interquartile range (IQR) to categorize the level and type of agreement (strong positive consensus, weak positive consensus, strong negative consensus, weak negative consensus, and disagreement). Forced-choice scale consensus thresholds are defined according to the criteria listed in Table 3.
Clinical impact scale items were rated on a scale of 1 to 10, with 1 indicating the lowest possible clinical impact to 10 indicating the highest possible clinical impact. This rating system was utilized to assess the perceived significance and practical relevance of each proposed recommendation or phenomenon in clinical settings. By assigning numerical values, panelists indicated the degree to which they believe a recommendation, principle, or circumstance will influence patient care, health care delivery, or outcomes. This scale provided a quantitative measure of the potential clinical importance of each statement, providing insights into how elements of patient care are both clinically meaningful and actionable. The results from the clinical impact scale guided the refinement of recommendations and clinical insights, ensuring that the final consensus reflects the most impactful and relevant practices for real-world application. The clinical impact rating responses were analyzed using median, mean, mode, and interquartile range (IQR) to categorize the level and type of agreement (strong consensus and moderate consensus). Clinical impact scale consensus thresholds are defined according to the criteria listed in Table 3.
Ordered response items were rated by allowing participants to drag-and-drop individual statements into a list ranking them in order of importance, with the first ordinal rank indicating the greatest importance and the last ordinal rank indicating the least importance. Open text fields were provided at the end of each section to allow participants to suggest modifications, provide rationale for their ratings, and propose new or excluded recommendations. The use of ordered response items in this Delphi study served to systematically capture and rank the priorities or preferences of the expert panel regarding specific recommendations or practices (Supplementary, Appendix B, items OR1-OR3). These items enabled participants to provide nuanced input by arranging options in order of perceived importance, relevance, or effectiveness, thereby offering insights into the relative value assigned to each item. This approach allowed the researchers to discern patterns in expert judgment, facilitating the identification of consensus on key priorities and areas requiring further deliberation or study. Additionally, ordered response items support the refinement of recommendations by highlighting areas of strong agreement or divergence, ensuring that the final consensus reflects both the collective expertise of the panel and the practical implications for clinical or operational contexts.
The round 2 survey included a total of 77 forced-choice scale items, 20 clinical impact rating items, and 3 ordered response items (Supplementary, Appendix B). While a third round of consensus via e-conference was initially planned to address unresolved discrepancies, it was deemed that individual interviews would be the most inclusive approach to identifying areas of consensus and controversy by offering panelists flexibility in participation and ensured that every participant had the opportunity to provide equal input during open-ended discussion. Efforts were made to identify and distinguish real clinical disagreements from those arising from fatigue or misunderstanding during one-on-one interviews. Four panelists opted to participate in this final interview stage. This iterative and inclusive approach ensured that the results reflected a broad range of expert perspectives while maintaining methodological rigor.
Consensus in this Delphi study was defined based on specific thresholds applied to the distribution of forced-choice scale responses, with metrics including the median, mean, and interquartile range (IQR). Strong positive consensus was defined as the median and mean ratings being between 4 and 5, with an IQR of ≤1, indicating high agreement and support for the recommendation, guideline, or principle. Moderate positive consensus was defined as median and mean being ≥3 and <4, with an IQR of <2, suggesting moderate agreement. Similarly, strong negative consensus was defined by median and mean ratings between 0 and 1, with an IQR of ≤1, reflecting strong opposition. Moderate negative consensus was defined as the median and mean falling between >1 and ≤2, with an IQR <2, indicating moderate disagreement. Disagreement, or lack of consensus, was defined as the IQR being ≥2, signifying significant variability in panelist responses and the absence of a clear collective opinion. These thresholds ensured a systematic and transparent evaluation of consensus levels for each recommendation.
Kendall’s W (Coefficient of Concordance) was employed to assess the level of agreement among experts when ranking ordered response survey items. Kendall’s W quantifies the degree of consensus by measuring the alignment of rankings provided by multiple respondents. It ranges from 0 (no agreement) to 1 (perfect agreement), making it a valuable tool for determining whether the panelists have a shared perspective on the relative importance or priority of survey items. A high Kendall’s W value indicates strong consensus, suggesting that the panelists are largely in agreement about the rankings of the items. Conversely, a low Kendall’s W value signifies a lack of consensus and variability in the rankings.14,15 By systematically applying Kendall’s W, the study ensures that agreement levels are objectively measured, guiding the iterative refinement process toward a cohesive, evidence-based set of recommendations.
A preliminary report detailing group responses, including qualitative feedback, was prepared and anonymized by the researchers and presented to participants who opted to participate in 1-on-1 interviews following the completion of the round 2 survey. The preliminary report consisted of the total number of respondents that selected each response option and mean score (forced-choice and clinical impact scale items), the rank sum and average rank (ordered response items), and open-ended responses.
Results
The areas of consensus derived from forced-choice scale survey items in this Delphi study highlight expert agreement on various aspects of SCIG therapy (Supplementary, Appendix A). Strong positive consensus was achieved on several clinical practices, including the importance of selecting appropriate needle length and placement based on individual patient factors, addressing infusion supply issues during initial assessments, and performing follow-up evaluations tailored to patient needs. There was also consensus on the clinical implications of needle length, optimal flow rates, and the influence of infusion system usability on training requirements. Cost considerations, such as the need to keep single-use supplies affordable, were also emphasized.
Moderate positive consensus was observed in areas related to patient comfort and practical aspects of infusion therapy, such as the role of adhesive dressings in skin irritation, the need for visual acuity assessments, and specific techniques for priming and needle insertion. Experts also agreed on the general principles guiding infusion rates, such as starting infusions slowly and adjusting based on patient tolerance, as well as the importance of education in mitigating supply inconsistencies.
In contrast, moderate negative consensus was reached on the feasibility of ensuring uniform supply distribution, such as guaranteeing a specific brand of pump for every patient. No items reached strong negative consensus, indicating minimal widespread disagreement among the panelists. Overall, the results reflect broad agreement on key clinical practices and supply management in SCIG therapy, while also highlighting areas where variability in practice persists.
Areas of consensus from the clinical impact survey items were categorized by the strength of agreement based on interquartile range (IQR) thresholds (Table 4). Strong consensus (IQR ≤ 2) was achieved on 2 items: the tendency of pumps/syringe drivers to break after more than 2 years of use and the potential for adhesive dressings to cause pain or discomfort during removal. These items had mean scores of 3.6 and 3.3, respectively, with median scores of 3, indicating moderate concern regarding their clinical impact.
Moderate consensus (IQR < 4) was observed for the statement that infusion site saturation can slow the infusion process and cause ulcerations. This item had a mean score of 4.9, a median of 5, and a mode of 5, suggesting a moderate to high perceived clinical impact. Overall, the results reflect a shared recognition of the potential complications associated with SCIG therapy equipment and infusion practices.
Ordered Responses
In the 3 ordered response items in this Delphi study, expert panelists ranked actions and qualities related to subcutaneous infusion therapy. For each ordered response item (OR1-OR3), key descriptive statistics such as median rank, mean rank, mode, rank sum, and squared deviations were calculated, alongside Kendall’s W (Coefficient of Concordance) to assess the level of agreement among respondents.
In OR1, which focused on actions for preventing infusion site reactions, Kendall’s W was calculated at 0.24, indicating weak agreement among the panelists. The most highly prioritized actions included using the “dry” priming technique and choosing the appropriate needle length, both achieving median ranks of 2. However, variability in rankings suggests a lack of strong consensus on other preventive actions (Figure 1).
OR2 evaluated qualities related to ease of use in infusion systems. This section showed a higher level of agreement with a Kendall’s W of 0.38. The highest-ranked quality was the ease of use supporting patient adherence, consistently ranked first by most panelists. Other factors, such as minimizing steps in instructions and ensuring safe needle insertion, were also prioritized, reflecting a moderate level of consensus around key usability aspects.
OR3 assessed priorities related to drug delivery, yielding a Kendall’s W of 0.34, indicating moderate agreement among the panelists. Delivering the infusion at the intended rate and ensuring the full prescribed dose were consistently ranked as top priorities, with median ranks of 2. However, there was more variability in the importance assigned to features like durability and maintenance requirements of the syringe driver.
Overall, the Kendall’s W values across the 3 categories suggest moderate to weak consensus among the expert panel.
Discussion
The findings of this modified Delphi study underscore the complexity and multifaceted nature of SCIG therapy supply management. By incorporating perspectives from pharmacists, infusion nurses, and prescribing providers, the study offers a comprehensive view of current practices, challenges, and priorities. Overall, the consensus patterns achieved highlight an overarching theme of patient-centered care, emphasizing simplified infusion systems, individualized approaches to ancillary supply selection, the importance of interdisciplinary collaboration, and collaboration with the patient to optimize outcomes.
Interviews
The final interview phase of this Delphi study offered further insights into SCIG therapy from panelists. Interviews were conducted by preparing a preliminary summary of survey results from rounds 1 and 2, which served to guide the discussion. Participant input underscored the need for patient-centered decision-making, interdisciplinary collaboration, and practical considerations to optimize therapy. Two prominent challenges consistently emerged: variable levels of training among infusion nurses and clinical educators, and the added complexity introduced by infusion devices or flow controllers.
Several clinicians emphasized in their practice the wide variability in nurse training, noting that agencies employing per diem staff often offer minimal instruction. This situation places a disproportionate burden on individual clinicians to seek out best practices independently, which can lead to inconsistencies in knowledge and, ultimately, affect patient outcomes. Conversely, agencies with robust internal education programs were described as providing more cohesive protocols and guidelines, thereby enhancing staff competency. The importance of standardizing basic training requirements was echoed repeatedly, reflecting a pressing need to ensure consistency in patient instruction, equipment use, and follow-up care.
Device complexity also emerged as a critical concern. Some participants noted that programmable infusion pumps, while advantageous in offering precise flow control, require detailed setup and place additional training demands on nurses and patients. When per diem clinicians lack sufficient preparation, the risk of user error and patient confusion increases. Devices that enable a syringe to be loaded directly, without disassembly or multi-step assembly, were repeatedly cited as preferable. Clinicians observed that simpler, more intuitive pumps foster greater confidence and adherence among patients, particularly those learning to manage therapy at home with limited external support.
The interviews further highlighted the importance of tailoring SCIG therapy to the individual. Clinicians underscored that needle length, gauge, and site selection should be guided by in-person evaluation whenever possible, given the anatomical and lifestyle differences among patients. Although the abdomen remains a popular site, other locations such as hips or thighs may prove more comfortable or practical, especially if large volumes require multiple injection sites. Equally critical is the recognition that strict flow-rate protocols do not always align with patient preferences. Many clinicians found it more successful to let patients select rates they tolerate best, as this autonomy contributes to better adherence. There was a similar openness to different methods of priming the infusion tubing, with some interviews pointing to a need for further data on “dry priming” techniques, and erroneous reports of subcutaneous emphysema at infusion site locations noted on imaging studies in clinical practice.
Supply management and communication between pharmacies, prescribing providers, and patients surfaced as another area requiring vigilance. While mismatched supplies or shipping errors were deemed unlikely to pose severe clinical hazards, they often cause logistical delays and may create frustration or lead to missed doses. These avoidable setbacks underscore the potential value of explicit prescriptions that specify particular pumps, needle lengths, and flow tubing, and the necessity of collaborative dialogue among all parties. At the same time, this practice should consider the pharmacist, nurse, and patient’s ability to troubleshoot or tailor supplies to the patient’s preference, as an explicit prescription may require prescriber approval to make changes. Many clinicians similarly stressed the importance of repeated patient education, particularly because the initial quantity of information can be overwhelming and affect the ability of patients to retain knowledge. Ongoing reinforcement, whether through scheduled visits or virtual follow-ups, helps ensure patients remain aware of options for altering needle length, adjusting flow rates, or modifying site selection.
Lastly, while many clinicians acknowledged the growing interest in off-label SCIG use—especially for conditions traditionally managed with IVIG— this expansion has been complicated by limited trial data and inconsistent payor policies. The interviews consistently recommended further research and clinical guidelines to address such gaps.
Overall, these final interviews underscored the dynamic nature of SCIG therapy and the essential role that flexible, patient-driven approaches play in promoting successful outcomes. Harmonizing training practices, simplifying pump designs, and maintaining transparent, responsive communication channels can help mitigate the risks posed by under-resourced education programs and overly complex infusion devices. Such measures, when combined with ongoing patient autonomy and thorough provider oversight, offer a promising path toward standardizing and enhancing SCIG administration across diverse clinical contexts.
Patient-Centered Approaches and Tailored Infusion Practices
A primary consensus emerged regarding the need to tailor SCIG infusion practices—particularly needle length, infusion site selection, and flow rate—to individual patient characteristics rather than relying solely on bodyweight or standardized protocols. These results align with previous literature indicating that interindividual variability, including skin integrity, subcutaneous tissue availability, and comfort levels, can significantly influence patients’ experiences and outcomes.16,17 Of particular note, panelists agreed that needle length too short or too long could respectively lead to dermal or intramuscular infiltration, heightening adverse events and potentially reducing therapeutic efficacy. Such nuanced infusion site management directly supports the tenets of patient-centric care, as it respects the unique physiological and lifestyle factors of each patient.
Preference for Simpler Infusion Systems
The preference for simplified infusion systems with fewer steps was another area of strong agreement, resonating with growing evidence that complex medical devices can lead to higher rates of user error, increased training demands, and lower adherence.18 Participants noted that systems requiring extensive programming or maintenance can impose undue burdens on both providers and patients. This inclination toward non-programmable devices may reflect a practical need to mitigate training fatigue and reduce inconsistencies in operational use. In keeping with these observations, participants also reported that a system’s ease of use directly affected the time and resources needed for patient education, underscoring how device simplicity can streamline clinical workflows and support sustainable homebased infusion programs.
Disciplinary Variations and Collaboration
Despite broad consensus on many aspects of SCIG supply management, the study revealed notable disciplinary variations, especially concerning optimal infusion rates. Pharmacists tended to prioritize standard protocols and cost-effectiveness, while nursing professionals emphasized real-time patient comfort and technical feasibility of adjusting infusion rates. Prescribers, on the other hand, often balanced clinical efficacy with insurance-mandated equipment constraints. These differences highlight the importance of sustained interdisciplinary dialogue to reconcile competing priorities and foster uniform best practices. In particular, the strong consensus on the necessity for ongoing patient education points to a clear opportunity for team-based coordination, ensuring that information is shared consistently and that patients understand how to adapt their infusion regimen safely.
Supply Inconsistencies and Cost Considerations
An additional challenge identified by participants pertains to supply variability, wherein brand or equipment substitutions may disrupt a patient’s established therapy routine. Panelists concurred that targeted education across all levels of the care continuum—clinicians, pharmacists, and manufacturers—represents the most feasible mitigation strategy. The cost dimension further complicates these issues; although experts generally agreed that lower-cost options do not necessarily compromise quality, many also noted that some cost-driven substitutions had resulted in increased leakage or technical difficulties. This dual focus on minimizing cost while maintaining or improving quality represents a critical area for future policy and procurement guidelines. Indeed, such findings echo broader discussions in health economics, wherein efficiency and patient-centeredness are often perceived to be at odds but can be reconciled through strategic innovation and value-based care models.19
Future Research and Innovation
Panelists consistently highlighted the lack of robust clinical trial data for SCIG therapy in certain autoimmune conditions—an area typically served by IVIG. Expanding the evidence base for SCIG in these indications could further validate its use and enhance uptake among clinicians wary of deviating from established IVIG protocols.20 Additionally, there was strong interest in innovative, non-programmable pumps that could handle variable syringe sizes and volumes. This focus on device innovation reflects the broader objective of reducing system complexity to improve patient adherence and reduce the likelihood of user error. Future research should also investigate the clinical impact of site saturation and flow rate configurations in diverse patient populations, including those with complex comorbidities. A more rigorous evidence base regarding optimal education, follow-up schedules, and infusion site selection could further refine the practical recommendations identified in this study.
Limitations
While the Delphi methodology enabled a structured approach to gather expert opinion, several limitations warrant consideration. First, the expert panel size was relatively small (n=9), potentially restricting the generalizability of the findings. Although heterogeneity across professional backgrounds was intentionally sought, the panel composition may not encompass the full range of perspectives across different health care systems or regions. Second, the transition to optional, individual interviews in the final round might have led to narrower insights, as only 4 of the original 9 participants opted in. Finally, the absence of patient and caregiver representatives, while consistent with the study design focusing on clinical expertise, precludes direct validation of the patient experiences and preferences reported indirectly by the expert panel.
Conclusion and Implications for Practice
Despite these limitations, the study offers actionable insights with broad implications for SCIG therapy. The strong consensus on individualized site selection, device simplicity, and patient-centered communication strategies provides a framework for standardizing SCIG programs in both home and specialty infusion settings.
By implementing robust training protocols and adopting flexible, easy-to-use devices, providers can reduce adverse events, enhance patient satisfaction, and potentially expand the eligible population for SCIG therapy. Furthermore, addressing cost concerns with systematic procurement policies that prioritize both patient safety and resource stewardship could improve consistency of supply. Ultimately, these measures align with the broader health care trend toward decentralization of specialty care, as more complex treatments, such as immunoglobulin replacement, migrate to the home setting.
In summary, this Delphi study reaffirms the critical role of multidisciplinary collaboration and patient-centered practices in SCIG therapy. By emphasizing tailored approaches to needle length, site selection, and infusion systems, the expert panel highlights a clear direction for advancing SCIG best practices. Continued research on novel device technologies and expanded clinical indications, coupled with sustained interdisciplinary communication, will be essential to optimize SCIG therapy’s safety, efficacy, and accessibility for diverse patient populations.
Disclosures: The results and conclusions presented in this study reflect the data accurately and impartially, without bias toward any specific product or manufacturer. This study received no external funding. The authors maintained full independence throughout the research process. For any questions about data integrity or potential conflicts of interest, please contact KORU Medical Systems at medicalaffairs@korumedical.com.
Supplementary Information: Appendix A and Appendix B can be found online. https://doi.org/10.70776/ZJVE7679.
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