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 distilled prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. Learned from the 10,348 direct Codex labels and 10,348 direct Gemma labels. Candidate is the union of thresholded teacher heads; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels or direct frontier model labels.
Codex and Gemma teacher scores by category
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.000 | 0.000 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.000 | 0.000 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.001 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.000 | 0.000 |
| Insufficient payload (model declined to judge) | 0.000 | 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 teacher head, 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".