Subcutaneous immunoglobulin replacement therapy in patients with immunodeficiencies – impact of drug packaging and administration method on patient-reported outcomes
Bibliographic record
Abstract
Abstract Background:Understanding the impact of subcutaneous immunoglobulin (SCIg) packaging (vials and pre-filled syringes [PFS]) and administration methods (pump and manual push) upon treatment experience can potentially facilitate optimization of patient outcomes. Here, the perspective of patients with primary and secondary immunodeficiency receiving SCIg was evaluated. Methods: An online survey conducted by the Associatin des Patients Immunodéficients du Québec (APIQ) (10/2020–03/2021) of patients in Canada contained questions on SCIg use: reasons for choosing packaging and administration methods, training experiences, self‑infusion characteristics, and switching packaging methods. The survey captured structured patient‑reported outcomes such as treatment satisfaction (via TSQM), symptom state (via PASS), general health perception (via GHP), and physical and mental function (via PROMIS). Respondents using SCIg were compared by their SCIg packaging, and then stratified by their administration method in a sub-analysis. Results: Sixty-six respondents were currently using vials, with 38 using a pump and 28 using manual push; 120 respondents were currently using PFS (5 and 10 mL sizes), with 38 using a pump and 82 using manual push. PFS users were associated with a significantly lower SCIg dose (p=0.02), a significantly shorter infusion preparation time (p=0.02), and a trend for shorter actual infusion time (p=0.07) compared with vial users. Treatment satisfaction was similar between vial and PFS users in terms of effectiveness and convenience, both overall and in the manual push subgroup; in the pump subgroup, vial users showed a trend for improved convenience compared with PFS users (p=0.07). Vial users were associated with greater global satisfaction compared with PFS users, both overall and in the manual push subgroup (both p=0.02). Conclusions: PFS users were associated with 17% lower SCIg dose compared with vial users, consistent with wastage caused by drawing the product into syringes from vials. PFS users were also associated with shorter pre-infusion times, reflecting simpler administration mechanics compared with vial users. Higher global satisfaction among vial users compared with PFS users may be due to incompatibility of currently available PFS and pump sizes, and sub-optimal SCIg training delivered during the COVID-19 pandemic; patient experience on PFS is expected to improve once these temporary factors resolve.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.002 | 0.005 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.000 | 0.001 |
| Bibliometrics | 0.000 | 0.001 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.001 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.000 | 0.000 |
| Insufficient payload (model declined to judge) | 0.001 | 0.000 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".