Patient Palatability and Preference Study of Three Potassium Binders in Patients with CKD and Hyperkalemia: Rationale and Design of the APPETIZE Study
Bibliographic record
Abstract
Background: Patients with CKD are at risk of hyperkalemia (HK) which has been associated with a higher risk of cardiovascular events and mortality. Recently approved K+ binders provide new treatment options to fulfil the unmet need for HK treatment beyond traditional K+ binders, which are poorly tolerated by patients and are associated with GI side effects. Methods: APPETIZE is a cross-sectional, randomised cross-over study with the aim to evaluate the palatability of and patient preference for 3 currently available K+ binders: Sodium Polystyrene Sulphonate (SPS) or Calcium Polystyrene Sulphonate (CPS), Sodium Zirconium Cyclosilicate (Lokelma®) and Calcium Patiromer Sorbitex (Veltassa®). A single (patient) blind side-by-side, sip and spit taste-test approach will be utilised where patients will be presented with a single full, per label dose of each product to replicate the real-world patient experience. Patient ratings, assessed on a 0-10 scale and emotional response using the AdSAM tool® to evaluate feelings (Appeal, Engagement and Empowerment) will be used to assess patient centric attributes: taste (primary outcome), texture, smell, mouthfeel and likelihood of adherence (secondary outcomes) of each product. Preferential ranking will be performed after all 3 products have been tested. Sixty CKD patients (both dialysis and non-dialysis) with HK per country (480 overall) from US, Canada, Spain, Italy, Germany, France, Sweden and Norway will be included, with equal proportions of patients ever-treated and never-treated with K+ binders. Results: APPETIZE will describe, compare and rank palatability and preference of 3 currently available K+ binders by country. Initial results are anticipated towards end of 2020. Conclusions: Utilizing innovative methodology, APPETIZE will generate evidence intended for patients and physicians (including nephrologists and cardiologists) regarding patient palatability, patient preference and predicted likelihood of adherence for currently available K+ binders.
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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 | 0.005 | 0.004 |
| Meta-epidemiology (narrow) | 0.001 | 0.001 |
| Meta-epidemiology (broad) | 0.003 | 0.002 |
| Bibliometrics | 0.001 | 0.001 |
| Science and technology studies | 0.001 | 0.002 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.001 | 0.001 |
| Research integrity | 0.002 | 0.002 |
| Insufficient payload (model declined to judge) | 0.007 | 0.001 |
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".