Results of a Delphi Panel to Address Management of Gastrointestinal Side Effects Observed with Use of Delayed-release Dimethyl Fumarate (P3.242)
Bibliographic record
Abstract
OBJECTIVE: To gain insight into gastrointestinal (GI) events associated with delayed-release dimethyl fumarate (DMF) from clinicians who treat patients with relapsing-remitting multiple sclerosis (RRMS), and to obtain consensus on effective management strategies and appropriate expectations for patients with GI events. BACKGROUND: Delayed-release DMF (240 mg twice daily) is approved for treatment of relapsing forms of MS (USA, Australia) or relapsing-remitting MS (Canada, EU). In clinical trials, events associated with GI tolerability (nausea, vomiting, abdominal pain, diarrhea) were more common in patients treated with delayed-release DMF compared with placebo-treated patients. The Delphi method (a consensus-building technique) was initiated in the US and Canada to obtain information about managing these side effects in a real-world setting. DESIGN/METHODS: A steering committee designed and conducted surveys of clinicians in the US and Canada whose MS patients receive treatment with delayed-release DMF. Two rounds of questionnaires were developed that include questions relating to clinician experience with treatment-associated GI events. Results from the first questionnaire were used to develop the second questionnaire and were provided along with the second questionnaire in an effort to obtain consensus on the management of each specific GI event. RESULTS: Sixty-four respondents completed the first round questionnaire. Most (63/64) indicated that 蠅1 of their patients had experienced GI side effects (typically <20[percnt] of patients). Most strategies attempted to manage the GI side effects, including food-based strategies, prescription medications, and/or nonprescription medications were reported as effective some of the time. The most frequently used strategies were included in the second round questionnaire to obtain consensus (蠅70[percnt] agreement) regarding their potential effectiveness. The final results of the Delphi process will be presented. CONCLUSIONS: Strategies identified by clinicians to manage GI events associated with delayed-release DMF will be important in clinical practice to improve tolerability and compliance. Study Supported by: Biogen Idec Inc.
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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 | 0.125 | 0.134 |
| Meta-epidemiology (narrow) | 0.001 | 0.001 |
| Meta-epidemiology (broad) | 0.001 | 0.001 |
| Bibliometrics | 0.002 | 0.001 |
| Science and technology studies | 0.003 | 0.002 |
| Scholarly communication | 0.001 | 0.002 |
| Open science | 0.001 | 0.007 |
| Research integrity | 0.002 | 0.002 |
| Insufficient payload (model declined to judge) | 0.003 | 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".