Telemedicine Technology Supporting the Diagnostic Process Based on Automated Analysis of Laboratory Test Results With a Structured Medical History: A Prospective, Two-Center, Two-Phase Clinical Validation Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 899
- 试验地点
- 2
- 主要终点
- Percentage of Participants for Whom the Urgency Category Assigned by the Software Was Not Lower Than the Category Assigned by the Expert Physician (Patient Triage Safety Indicator)
研究概览
简要总结
This study evaluates a certified artificial intelligence (AI) based software system that automatically interprets laboratory test results in combination with a structured, dynamically generated medical history questionnaire.
The purpose of the study is to determine how accurately and how safely the system assigns a patient to a category of urgency of medical contact, and how closely the interpretations produced by the system correspond to the assessment of an expert physician.
Adults treated at two university hospitals in Katowice, Poland, who are referred for laboratory testing, complete an electronic medical history questionnaire after their laboratory results become available. The system then generates an interpretation for each laboratory result, including a category of urgency of medical contact, a suggested medical specialty and suggested further laboratory tests. The attending physician independently records a clinical assessment of the same laboratory results and medical history without access to the output of the system. An independent expert physician subsequently establishes the reference assessment, blinded to the authorship of the assessments being compared. The interpretation report is released to the participant only after the assessment of the attending physician has been recorded and locked.
The study is conducted in two phases. The first phase (609 participants) is exploratory and uses the initial version of the system. The second phase (290 participants) is confirmatory and uses the final, frozen version of the system. All outcome measures are assessed in both phases; the pre-specified confirmatory hypothesis test applies to the second phase.
The endpoints of this study are properties of the software system, namely the concordance of its output with an expert reference assessment. Health outcomes of participants are not measured.
详细描述
Design. LTC-VALID is a prospective, two-center, single-arm, two-phase clinical validation study of a CE-marked class IIa medical device software intended for the automated interpretation of laboratory test results.
Phase structure. Phase I (609 participants, months 1 to 9) is exploratory and serves algorithm development and gap identification using version 1.0 of the software. An interposed optimization stage (months 9 to 10) produces a frozen version 2.0. Phase II (290 participants, months 11 to 13) is confirmatory. All outcome measures listed below are collected identically in both phases and are reported separately by phase. Results from the two phases are not pooled, because the two phases evaluate different versions of the software. The pre-specified confirmatory hypothesis test for the co-primary measures is applied to Phase II data; Phase I results for the same measures are exploratory and are reported descriptively.
Procedures. Eligible participants provide written informed consent, are referred for a mandatory basic laboratory panel and one or two of 29 specialist laboratory panels, and provide a single blood draw at a certified laboratory collection point. After the results become available, the participant completes a dynamically generated electronic medical history questionnaire. The software produces one interpretation per laboratory result; interpretations are not aggregated by the software. The attending physician records an independent clinical assessment of the same data while blinded to the software output; this assessment is locked before the interpretation report is released to the participant. Participants complete a questionnaire evaluating the report, and physicians complete a form evaluating the completeness and relevance of the automated medical history.
Reference standard and comparators. An independent expert physician receives the complete documentation and establishes an own reference assessment before reviewing the assessments to be compared. The assessments of the software, of the attending physician and of large language models are presented in random order and blinded as to authorship. The comparators are comparators of assessment, not study arms; the study is single-arm and no randomization or control group is used.
Reporting standard. The primary analysis follows the Standards for Reporting of Diagnostic Accuracy Studies (STARD). The study is a diagnostic accuracy study and not a study of clinical effectiveness.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Treated at one of the two participating clinical centers of the Medical University of Silesia
- •Age 18 years or older and under 80 years
- •Presence of symptoms justifying the initiation of a diagnostic work-up
- •Meets the criteria for ordering at least one of the 29 specialist laboratory panels included in the study
- •Able to complete an electronic questionnaire in Polish independently, using a smartphone or a personal computer
- •Holds a Polish national identification number (PESEL)
- •Written informed consent covering all three components of the study
排除标准
- •Pregnancy
- •Age 80 years or older
- •Inability to provide informed consent, including cognitive impairment or a language barrier
- •Participation in another clinical study that could affect the results
- •Refusal of consent to any of the three components of the study
研究组 & 干预措施
AI-Based Interpretation of Laboratory Test Results
Single arm. All participants complete an electronic, dynamically generated medical history questionnaire administered by the software after their laboratory results become available, and subsequently receive a software-generated interpretation report. The report is released to the participant only after the independent clinical assessment of the attending physician has been recorded and locked. No control group is used. The assessments of the attending physician, of an independent expert physician and of large language models are comparators of assessment and do not constitute study arms.
干预措施: AI-based laboratory result interpretation software (Diagnostic Test)
结局指标
主要结局
Percentage of Participants for Whom the Urgency Category Assigned by the Software Was Not Lower Than the Category Assigned by the Expert Physician (Patient Triage Safety Indicator)
时间窗: Through completion of the expert reference assessment for all enrolled participants, up to 16 months after study start
The urgency category assigned by the software is compared with the urgency category assigned by an expert physician serving as the reference standard. The urgency categories, ordered from highest to lowest, are: immediate medical contact, urgent medical contact, routine medical contact, and no need for medical contact. A participant is counted in the numerator when the category assigned by the software is the same as or higher than the category assigned by the expert physician. The measure is the percentage of participants counted in the numerator. Range: 0 to 100 percent; higher values indicate better performance. The measure is assessed separately in each study phase and data from the two phases are not combined. Each comparison is based on data locked at the time of enrollment; the expert assessment is performed retrospectively, in batches, on a locked dataset, and the calendar timing of the batch review does not affect the measured quantity.
Percentage of Participants for Whom the Urgency Category Assigned by the Software Was Identical to the Category Assigned by the Expert Physician (Patient Triage Accuracy)
时间窗: Through completion of the expert reference assessment for all enrolled participants, up to 16 months after study start
The urgency category assigned by the software is compared with the urgency category assigned by an expert physician serving as the reference standard. The urgency categories, ordered from highest to lowest, are: immediate medical contact, urgent medical contact, routine medical contact, and no need for medical contact. A participant is counted in the numerator when the category assigned by the software is identical to the category assigned by the expert physician. The measure is the percentage of participants counted in the numerator. Range: 0 to 100 percent; higher values indicate better performance. The measure is assessed separately in each study phase and data from the two phases are not combined. Each comparison is based on data locked at the time of enrollment; the expert assessment is performed retrospectively, in batches, on a locked dataset, and the calendar timing of the batch review does not affect the measured quantity.
次要结局
- Sensitivity for the Immediate Medical Contact Category(Through completion of the expert reference assessment for all enrolled participants, up to 16 months after study start)
- Sensitivity for the Urgent Medical Contact Category(Through completion of the expert reference assessment for all enrolled participants, up to 16 months after study start)
- Agreement on Urgency Category Measured by Quadratic Weighted Cohen's Kappa(Through completion of the expert reference assessment for all enrolled participants, up to 16 months after study start)
- Per-Result Concordance on Recommended Medical Specialty(Through completion of the expert reference assessment for all enrolled participants, up to 16 months after study start)
- Per-Result Concordance on Recommended Additional Laboratory Tests(Through completion of the expert reference assessment for all enrolled participants, up to 16 months after study start)
- Comparative Concordance of the Software, the Attending Physician and Large Language Models Against the Reference Standard(Months 15 to 18 after study start)
- Proportion of Participants Rating the Interpretation Report as Comprehensible(Immediately after release of the report)
- Proportion of Automated Medical History Records Assessed by the Attending Physician as Complete and Relevant(Immediately after the assessment of the attending physician)