Clinical Validation of an Artificial Intelligence System for the Interpretation of Laboratory Test Results Combined With a Structured Medical History (LTC-VALID)
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
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.
調査の概要
状態
詳細な説明
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.
Statistical approach. The two primary outcome measures are co-primary and are evaluated using an intersection-union test; both must meet their pre-specified criteria. The pre-specified criteria apply to Phase II: for the safety measure, the lower bound of the one-sided 95 percent confidence interval is at or above 95 percent; for the accuracy measure, at or above 90 percent. Confidence intervals for proportions are calculated using exact methods (Clopper-Pearson). Phase I is exploratory and its data are reported descriptively. Sensitivity for the rare urgency categories is reported with confidence intervals and event counts as a secondary, non-confirmatory measure, because its denominator is not sufficient for formal hypothesis testing at the planned sample size.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Jerzy Chudek, MD, PhD
- 電話番号：+48322591202
- メール：clinicaltrials@labplus.pl
研究場所
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Katowice、ポーランド
- Independent Public Clinical Hospital named after Andrzej Mielecki, Medical University of Silesia
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コンタクト：
- Jerzy Chudek
- 電話番号：+48322591202
- メール：clinicaltrials@labplus.pl
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Katowice、ポーランド
- Prof. K. Gibinski University Clinical Center, Medical University of Silesia
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コンタクト：
- Michal Holecki, MD, PhD
- 電話番号：+48322591202
- メール：clinicaltrials@labplus.pl
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参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：診断
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：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.
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A CE-marked class IIa medical device software for the automated interpretation of laboratory test results, operated within its intended purpose.
The software administers a structured medical history questionnaire in which subsequent questions are selected dynamically on the basis of the laboratory results and of previous answers.
For each laboratory result the software generates one interpretation, comprising a category of urgency of medical contact (immediate, urgent, routine, or no need for medical contact), a suggested medical specialty, a list of suggested further laboratory tests, and an explanatory text addressed to the patient.
Interpretations are not aggregated by the software.
The interpretation report is generated once per participant, after completion of the questionnaire, and is released to the participant after the assessment of the attending physician has been recorded and locked.
The generated report is not used to direct the clinical management of the participant.
他の名前：
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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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)
時間枠：Through completion of the expert reference assessment for all enrolled participants, up to 16 months after study start
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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.
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Through completion of the expert reference assessment for all enrolled participants, up to 16 months after study start
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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)
時間枠：Through completion of the expert reference assessment for all enrolled participants, up to 16 months after study start
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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.
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Through completion of the expert reference assessment for all enrolled participants, up to 16 months after study start
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Sensitivity for the Immediate Medical Contact Category
時間枠：Through completion of the expert reference assessment for all enrolled participants, up to 16 months after study start
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Proportion of participants assigned by the expert physician to the immediate medical contact category who were assigned to the same category by the software.
Range: 0 to 100 percent; higher values indicate better performance.
Reported with a 95 percent confidence interval and the number of events.
No formal hypothesis test is performed, because the expected denominator at the planned sample size is not sufficient for confirmatory testing.
Assessed separately in both study phases.
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Through completion of the expert reference assessment for all enrolled participants, up to 16 months after study start
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Sensitivity for the Urgent Medical Contact Category
時間枠：Through completion of the expert reference assessment for all enrolled participants, up to 16 months after study start
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Proportion of participants assigned by the expert physician to the urgent medical contact category who were assigned to the same category by the software.
Range: 0 to 100 percent; higher values indicate better performance.
Reported with a 95 percent confidence interval and the number of events.
No formal hypothesis test is performed, because the expected denominator at the planned sample size is not sufficient for confirmatory testing.
Assessed separately in both study phases.
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Through completion of the expert reference assessment for all enrolled participants, up to 16 months after study start
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Agreement on Urgency Category Measured by Quadratic Weighted Cohen's Kappa
時間枠：Through completion of the expert reference assessment for all enrolled participants, up to 16 months after study start
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Agreement between the urgency category assigned by the software and by the expert physician, expressed as Cohen's kappa with quadratic weights applied to the four ordered urgency categories.
Range: -1 to 1; higher values indicate better agreement.
Reported with a 95 percent confidence interval.
Supplementary to the co-primary measure of accuracy.
Assessed separately in both study phases.
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Through completion of the expert reference assessment for all enrolled participants, up to 16 months after study start
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Per-Result Concordance on Recommended Medical Specialty
時間枠：Through completion of the expert reference assessment for all enrolled participants, up to 16 months after study start
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Concordance between the medical specialty recommended by the software and by the expert physician, evaluated at the level of a single laboratory result.
Reported as precision and macro-averaged recall.
Range: 0 to 1; higher values indicate better performance.
Assessed separately in both study phases.
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Through completion of the expert reference assessment for all enrolled participants, up to 16 months after study start
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Per-Result Concordance on Recommended Additional Laboratory Tests
時間枠：Through completion of the expert reference assessment for all enrolled participants, up to 16 months after study start
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Concordance between the additional laboratory tests recommended by the software and by the expert physician, evaluated at the level of a single laboratory result.
Reported as precision and macro-averaged recall.
Range: 0 to 1; higher values indicate better performance.
Assessed separately in both study phases.
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Through completion of the expert reference assessment for all enrolled participants, up to 16 months after study start
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Comparative Concordance of the Software, the Attending Physician and Large Language Models Against the Reference Standard
時間枠：Months 15 to 18 after study start
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Concordance of three sources of assessment - the software, the attending physician and large language models - with the same expert reference assessment, using the measures defined above.
Assessments are compared retrospectively on a locked dataset.
Reported descriptively for each source; no ranking test is performed.
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Months 15 to 18 after study start
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Proportion of Participants Rating the Interpretation Report as Comprehensible
時間枠：Immediately after release of the report
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Proportion of participants who, in a study-specific questionnaire completed after release of the interpretation report, indicate that the content of the report was comprehensible.
Range: 0 to 100 percent; higher values indicate better performance.
Assessed separately in both study phases.
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Immediately after release of the report
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Proportion of Automated Medical History Records Assessed by the Attending Physician as Complete and Relevant
時間枠：Immediately after the assessment of the attending physician
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Proportion of automated medical history records for which the attending physician reports no objections regarding completeness or relevance, recorded in a study-specific form.
Range: 0 to 100 percent; higher values indicate better performance.
Assessed separately in both study phases.
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Immediately after the assessment of the attending physician
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協力者と研究者
スポンサー
捜査官
- 主任研究者：Jerzy Chudek, MD, PhD、Medical University of Silesia in Katowice
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- LP004
- FEDS.01.02-IP.01-0078/24 (その他の助成金/資金番号：European Funds for Lower Silesia 2021-2027 (FEDS))
- BNW/NWN/0052/KB1/34/26 (その他の識別子：Bioethics Committee, Medical University of Silesia in Katowice)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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