Specialist Physician Validation of the NOHARM Harm-Rating Rubric for Clinical Responses
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 80
- 主要终点
- Inverse-Probability-Weighted Confirmation of Rubric-Severe Classifications
研究概览
简要总结
The purpose of this study is to determine how closely potential-harm ratings assigned using the NOHARM rubric agree with independent ratings from specialty-matched physicians. The study uses reconstructed clinical consultation cases and previously generated responses written by artificial intelligence systems or physicians. The materials contain no patient identifiers or protected health information. Board-certified attending physicians from 10 medical specialties will review assigned case-response pairs through a secure website. For each response, they will indicate whether it contains an error, describe the error when applicable, and rate the greatest potential patient harm as none, mild, moderate, or severe. Reviewers will not be shown the response source, existing rubric rating, or other reviewers' ratings. Two specialists will initially review each response; a third may review it if the first two ratings differ. The study includes a development stage, possible rubric revision, and a separate validation stage.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Licensed or registered physician in good standing
- •Attending- or consultant-level physician actively practicing in allergy and immunology, cardiology, dermatology, endocrinology, gastroenterology, hematology, infectious disease, nephrology, neurology, or pulmonology
- •Practicing in the United States, Canada, United Kingdom, or Australia
- •Assigned clinical materials match the physician's specialty
- •Able to read and respond in English
- •Access to a computer with a stable internet connection
- •Willing and able to complete at least one remote specialist-rating engagement of approximately three hours
排除标准
- •Does not meet the professional, career-level, specialty, geographic, or credential-verification requirements above
- •Prior involvement with assigned cases, responses, or rubric information that could compromise independent rating
- •Unable to complete the remote rating activities in English
- •Unable or unwilling to follow the independent-rating procedures
- •For validation-stage assignments, participation in the rubric-revision process
研究组 & 干预措施
Specialist Physician Reviewers
Licensed or registered attending- or consultant-level physicians practicing in one of the represented medical specialties in the United States, Canada, United Kingdom, or Australia. Participants will independently review and rate reconstructed clinical case-response pairs during the development stage, validation stage, or both. Physicians involved in rubric revision will not provide validation-stage ratings.
结局指标
主要结局
Inverse-Probability-Weighted Confirmation of Rubric-Severe Classifications
时间窗: At completion of the development and validation stages, up to 2 months
The inverse-probability-weighted proportion of responses classified as severe by the NOHARM rubric that are also classified as severe by specialist consensus: P(specialist severe \| rubric severe). This measure will be calculated separately for the development and validation stages. Values range from 0 to 1; higher values indicate greater confirmation. The prespecified threshold is 0.70.
Inverse-Probability-Weighted Capture of Specialist-Severe Classifications
时间窗: At completion of the development and validation stages, up to 2 months
The inverse-probability-weighted proportion of responses classified as severe by specialist consensus that are also classified as severe by the NOHARM rubric: P(rubric severe \| specialist severe). This measure will be calculated separately for the development and validation stages. Values range from 0 to 1; higher values indicate greater capture. The prespecified threshold is 0.70. Both co-primary measures must meet this threshold.
次要结局
未报告次要终点
研究者
Jonathan Chen
Associate Professor of Medicine
Stanford University