Immunotherapy with check-point inhibitors (CPI) in adult malignancies: a protocol for the systematic review of the quality of economic analyses
Bibliographic record
Abstract
BACKGROUND: Immuno-oncology, and in particular, check-point inhibitors (CPIs), have led to a paradigm shift in the field of cancer care. The cost of new drug development is high, and many novel agents in oncology are significantly more expensive than older agents. Therefore, healthcare funders have factored measures of cost-effectiveness into decisions concerning drug reimbursement and incorporation of new agents into treatment algorithms. The methodology of cost-effectiveness evaluations, however, is less rigorously applied than those evaluating clinical efficacy and safety data. Thus, in spite of many regulatory bodies having approved CPIs based on existing economic analyses, to date, there has not been a systematic evaluation of the quality of health economic studies conducted on this new class of agents. Therefore, we propose to systematically review the methodologic and reporting quality of cost-effectiveness and cost-utility studies assessing CPIs to alternate established therapies, other immuno-oncology regimens, or placebo, in adults with malignancies. METHODS/DESIGN: The systematic review will include all published economic evaluations of CPIs compared with at least one other treatment in adult patients with solid or hematologic malignancies. A search will be performed to identify relevant studies in Ovid MEDLINE, EMBASE, Cost-effectiveness Analysis Registry, Evidence-Based Medicine Reviews, and the NIHR-HTA database. The titles and abstracts of all identified studies will be independently reviewed by two reviewers, who will then assess the full text of all articles deemed to meet eligibility criteria. Assessed articles will be screened for compliance with the Consolidated Health Economic Evaluation Reporting Standards (CHEERS) criteria. The association, with CHEERS criteria, of the journal impact factor, publication year, funding source, tumor site, trial or model-based study, and CPIs studied, will then be assessed. DISCUSSION: The systematic review will aim to provide an overview of the quality of economic analyses evaluating CPIs for the treatment of malignancies in adult patients. Any systemic or recurrent deficiencies in methodological or reporting quality will be described and used to inform recommendations for improved reporting of economic analyses. SYSTEMATIC REVIEW REGISTRATION: This review will not be registered with PROSPERO, it does not meet the eligibility criterion of addressing an outcome of the direct patient or clinical relevance.
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How this classification was reachedexpand
Direct model labels (unvalidated)
Per-model category and study-design labels from the labeling rounds. They are machine output, unvalidated, and the disagreement between models ships as data. No study design here is MEDLINE-validated yet.
| Model arm | Categories | Study design | Confidence |
|---|---|---|---|
| gemma | no category Domain: not available · Genre: Protocol About the Canadian research system: no · About a Canadian topic: no | Systematic review | low |
| gpt | Metaresearch Domain: Evaluation · Genre: Protocol About the Canadian research system: no · About a Canadian topic: no | Systematic review | medium |
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 | 0.010 | 0.001 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.004 | 0.001 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.000 |
| 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, unvalidatedLabeled directly by 2 models reading the full record.
The models disagree on parts of this classification; every voice is preserved in the section at the end of the page.
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".