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Patient AI Trust Dynamics Before and After Orthopedic Consultation (ORTHO-OP-GPT) (ORTHO-OP-GPT)

2026年8月26日 更新者:Utku Gürhan

Longitudinal Pre-Post Patient AI Trust Dynamics in Orthopedic Outpatients: A Mixed-Methods Observational Study With Matched Physician-Patient Dyads

Patients increasingly consult artificial intelligence (AI) chatbots such as ChatGPT for health information before clinical visits, yet the impact of an actual orthopedic consultation on patient trust in AI-derived information remains unknown. This prospective longitudinal observational study quantifies how a single orthopedic outpatient consultation modifies patient trust in AI chatbots, the concordance between AI-derived and physician-delivered information, and patient anxiety, using a paired pre-post survey design supplemented by a matched physician-side assessment. Adult patients (18 years and older) presenting to two orthopedic outpatient clinics in Cyprus complete a brief pre-consultation questionnaire (T0) capturing demographics, AI use patterns, prior AI consultation regarding the current complaint, baseline trust, expectations, and anxiety. Immediately after their consultation they complete a second questionnaire (T1) assessing concordance with physician advice, trust change, consultation facilitation, post-consultation anxiety, and future intention. The consulting physician completes a brief 30-second post-visit form capturing whether AI was discussed, the medical accuracy of AI-derived information conveyed by the patient, and the effect of the AI discussion on consultation duration. The primary outcomes are the paired within-patient change in AI trust between T0 and T1 and physician-patient concordance on AI versus physician advice. Target enrollment was 180 to obtain 150 paired completed assessments; 350 participants were enrolled.

調査の概要

詳細な説明

Background and Rationale: Cross-sectional surveys have documented increasing patient use of AI chatbots for health information seeking. However, no published study has assessed how an actual physician consultation modifies patient trust in AI in a paired pre/post design, nor has any study captured the physician perspective on the same encounter in a matched dyad. Routine clinical encounters may be the primary mechanism by which patients calibrate their trust in AI-derived medical information.

Setting and Population: Two university-affiliated orthopedic outpatient clinics in North Cyprus.

Procedures:

  • T0 (pre-consultation, waiting room, approximately 5 minutes): 14-item self-report questionnaire.
  • Consultation: usual care.
  • T1 (post-consultation, departure, approximately 5 minutes): 10-item self-report questionnaire.
  • Physician form (post-consultation, approximately 30 seconds): 5-item brief assessment.
  • Patient and physician forms are linked by an anonymous Participant ID.

Statistical Analysis Plan: Paired t-tests or Wilcoxon signed-rank tests for paired continuous outcomes; McNemar test or Stuart-Maxwell for paired categorical outcomes; Cohen's kappa for inter-rater agreement (AI versus physician); multinomial logistic regression for predictors of trust shift. All analyses two-sided, alpha equals 0.05. SPSS version 28.

Data Management: Anonymous CSV stored locally, encrypted, retained for 5 years per institutional policy. De-identified participant-level data available upon reasonable request after publication.

No formal pilot study is conducted. Instead, the first 20 participants will be prospectively monitored for protocol feasibility (mean completion time, drop-out rate, item-level missing data) as an embedded running pilot.

研究の種類

観察的

入学 (実際)

350

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

      • Kyrenia、キプロス
        • University of Kyrenia, Dr. Suat Gunsel Hospital - Orthopedic Outpatient Clinic
      • Nicosia、キプロス
        • Near East University Hospital - Orthopedic Outpatient Clinic

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

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

いいえ

サンプリング方法

非確率サンプル

調査対象母集団

Consecutive adult patients (18 years and older) presenting to the participating orthopedic outpatient clinics during the recruitment window who consent to participate. No specific orthopedic diagnosis is required.

説明

Inclusion Criteria:

  • Age 18 years or older
  • Presenting to an orthopedic outpatient clinic for any consultation
  • Able to read and respond to a Turkish-language questionnaire
  • Provides informed consent

Exclusion Criteria:

  • Inability to complete a self-report questionnaire (e.g., severe cognitive impairment, language barrier)
  • Re-presentation within the same recruitment window (each patient is enrolled only once)
  • Refusal of consent for either T0 or T1

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか?

デザインの詳細

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
Mean within-patient change in self-reported trust in artificial intelligence-derived health information, measured by a study-specific 5-point Likert item (T0.11) and a study-specific 3-level categorical change item (T1.4).
時間枠:Baseline (within 15 minutes pre-consultation in the orthopaedic outpatient waiting room) and immediately after the consultation (within 15 minutes of consultation exit, same-day index visit).
Trust in AI-derived health information is assessed pre-consultation by a study-specific single-item 5-point Likert scale (item T0.11: "How much do you trust the AI's answer?"; anchors 1 = not at all, 5 = completely), administered only to patients who reported pre-consultation AI use (item T0.9 = Yes). Post-consultation, trust change is reassessed by a study-specific 3-level categorical item (item T1.4: increased trust / unchanged / decreased trust). For paired analysis, the post-consultation score is derived by mapping T1.4 categories to integer shifts (+1 / 0 / -1, with floor 1 and ceiling 5) relative to T0.11. Unit of measure: Likert score points on a 1-5 scale (continuous derived score) and proportion of patients per 3-level category. Primary analysis: paired Wilcoxon signed-rank test on the derived continuous score; sensitivity analysis: McNemar test on the 3-level categorical change.
Baseline (within 15 minutes pre-consultation in the orthopaedic outpatient waiting room) and immediately after the consultation (within 15 minutes of consultation exit, same-day index visit).
Patient-physician concordance on artificial intelligence-versus-physician medical advice agreement, measured by Cohen's kappa coefficient between a study-specific 4-category patient item (T1.2) and a study-specific 5-point physician-rated AI medical accu
時間枠:Immediately after the consultation (within 15 minutes of consultation exit), for both patient (T1.2) and physician (H2) forms; same-day index visit.
Concordance is assessed by Cohen's kappa coefficient comparing patient-reported AI-physician concordance (item T1.2: fully concordant / partially concordant / discordant / physician did not address; dichotomized to concordant vs. non-concordant) and physician-reported AI medical accuracy (item H2: 5-point Likert anchored 1 = entirely incorrect to 5 = entirely correct; dichotomized at ≥ 3 as concordant). Unit of measure: kappa coefficient (range -1 to +1) with 95% confidence interval, and percentage of dyads classified as concordant on each instrument.
Immediately after the consultation (within 15 minutes of consultation exit), for both patient (T1.2) and physician (H2) forms; same-day index visit.

二次結果の測定

結果測定
メジャーの説明
時間枠
Percentage of enrolled patients reporting pre-consultation artificial intelligence use for the current orthopaedic complaint, measured by a study-specific single-item yes/no question (T0.9).
時間枠:Baseline (within 15 minutes pre-consultation, same-day index visit).
Proportion of enrolled patients responding "Yes" to item T0.9 ("Before today's appointment, did you ask an AI chatbot a question about this health concern?"). Unit of measure: percentage of participants, reported with exact (Clopper-Pearson) 95% confidence interval.
Baseline (within 15 minutes pre-consultation, same-day index visit).
Percentage of pre-consultation artificial-intelligence users whose physician independently confirmed that AI was raised during the consultation, measured by a study-specific yes/no physician item (H1).
時間枠:Baseline (T0.9, pre-consultation) and immediately after the consultation (H1, within 15 minutes of consultation exit), same-day index visit.
Among patients responding "Yes" to T0.9, the proportion in whom the treating physician independently reported "Yes" to item H1 ("Did the patient raise AI during this consultation?"). Unit of measure: percentage of patients with exact 95% confidence interval.
Baseline (T0.9, pre-consultation) and immediately after the consultation (H1, within 15 minutes of consultation exit), same-day index visit.
Percentage of consultations in which the physician reported that the artificial-intelligence discussion shortened, did not change, or prolonged the encounter, measured by a study-specific 3-category physician item (H3).
時間枠:Immediately after the consultation (within 15 minutes of consultation exit), same-day index visit.
Among consultations in which the patient raised AI (H1 = Yes), the physician's categorical rating of effect on consultation duration (H3: "shortened" / "no change" / "prolonged"). Unit of measure: percentage of consultations per category (descriptive).
Immediately after the consultation (within 15 minutes of consultation exit), same-day index visit.
Mean patient rating of how prior artificial-intelligence use facilitated the consultation, measured by a study-specific 5-point Likert item (T1.4b: 1 = much more difficult, 5 = much easier).
時間枠:Immediately after the consultation (within 15 minutes of consultation exit), same-day index visit.
Among patients with T0.9 = Yes, patient-reported facilitation by prior AI use (item T1.4b). Unit of measure: Likert score points (mean with standard deviation), and percentage of participants endorsing scores ≥ 4.
Immediately after the consultation (within 15 minutes of consultation exit), same-day index visit.
Mean patient-reported future intention to use and to recommend artificial intelligence for health information, measured by two study-specific 5-point Likert items (T1.7 future use; T1.8 recommendation to a friend).
時間枠:Immediately after the consultation (within 15 minutes of consultation exit), same-day index visit.
Future-use intention (item T1.7: 1 = definitely will not, 5 = definitely will) and recommendation intention (item T1.8: 1 = definitely will not, 5 = definitely will). Unit of measure: Likert score points (mean with standard deviation), and percentage of participants endorsing scores ≥ 4 on each item.
Immediately after the consultation (within 15 minutes of consultation exit), same-day index visit.
Mean within-patient change in consultation-related anxiety, measured by a study-specific six-item instrument (four-item anxiety subscale, range 4-20).
時間枠:Baseline (within 15 minutes pre-consultation) and immediately after the consultation (within 15 minutes of consultation exit), same-day index visit.
Anxiety is measured immediately before and immediately after the consultation using a study-specific six-item instrument modelled on the Amsterdam Preoperative Anxiety and Information Scale, with the referent moved from an impending procedure to the outpatient consultation. The anxiety subscale is the sum of four items (range 4-20). Protocol change: the 0-10 visual analogue scale originally registered for this outcome (items T0.14 and T1.5) was replaced by this instrument before data collection began and was never administered. Unit of measure: scale points. Analysis: paired t-test, with analysis of covariance for between-group comparison.
Baseline (within 15 minutes pre-consultation) and immediately after the consultation (within 15 minutes of consultation exit), same-day index visit.

その他の成果指標

結果測定
メジャーの説明
時間枠
Exploratory association between categorical post-consultation trust change and demographic predictors, estimated by multinomial logistic regression with the study-specific 3-level trust change item (T1.4) as the outcome and age band, sex, education level
時間枠:Through study completion, an average of 12 months from first enrolment.
Multinomial logistic regression model: outcome = T1.4 (decreased / unchanged / increased trust, reference category = unchanged); predictors = age band (5-level), sex (3-level), education (5-level), employment status, weekly internet-use frequency. Unit of measure: adjusted odds ratios with 95% confidence intervals.
Through study completion, an average of 12 months from first enrolment.
Internal consistency of a four-item artificial-intelligence trust subscale, measured by Cronbach's alpha across items T0.11 (baseline trust), T1.4 (post-consultation trust change, linearly recoded), T1.7 (future-use intention), and T1.8 (recommendation
時間枠:Through study completion, an average of 12 months from first enrolment.
Cronbach's alpha is estimated on the final analytic sample using the four trust-related Likert items listed. Unit of measure: alpha coefficient (range 0 to 1) with bootstrap 95% confidence interval.
Through study completion, an average of 12 months from first enrolment.

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スポンサー

捜査官

  • 主任研究者:Utku Gurhan, MD、University of Kyrenia

出版物と役立つリンク

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一般刊行物

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2026年6月1日

一次修了 (実際)

2026年7月31日

研究の完了 (実際)

2026年7月31日

試験登録日

最初に提出

2026年5月18日

QC基準を満たした最初の提出物

2026年6月1日

最初の投稿 (実際)

2026年6月8日

学習記録の更新

投稿された最後の更新 (実際)

2026年8月31日

QC基準を満たした最後の更新が送信されました

2026年8月26日

最終確認日

2026年8月1日

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