ICF-Based Biopsychosocial Assessment With AI-Assisted Profile Prediction: Trapeziometacarpal Osteoarthritis Model

Официальное название

ICF-Based Biopsychosocial Assessment With Artificial Intelligence-Assisted Profile Prediction: Trapeziometacarpal Osteoarthritis Model

Обзор

Trapeziometacarpal osteoarthritis (TMC OA) is a common condition affecting the base of the thumb that causes pain, weakness, and difficulty with daily hand use. Current clinical assessment often focuses on physical findings alone, without considering psychological and social factors that also influence patient outcomes. This study has three objectives organized as interrelated work packages: OBJECTIVE 1 (Clinical Assessment): To comprehensively assess individuals with TMC OA using the International Classification of Functioning, Disability and Health (ICF) framework. This includes evaluating pain, joint mobility, grip strength, daily activity limitations, social participation, psychological factors (anxiety, depression, fear of movement, pain beliefs), and environmental factors (family support, ergonomic adaptations). OBJECTIVE 2 (AI Knowledge Evaluation): To compare the medical knowledge performance of four large language models (Claude, ChatGPT, Gemini, LLaMA) in answering clinical questions about TMC OA, using criteria such as accuracy, reproducibility, comprehensiveness, clinical relevance, and readability. OBJECTIVE 3 (AI-Based Prediction): To analyze whether the best-performing large language model can predict multidimensional ICF-based patient profiles using only a limited set of core clinical parameters.

Подробное описание

This research consists of three independent but interrelated work packages with different methods and targets.

Work Package 1 (Clinical Data Collection and ICF-Based Profile Analysis): Participants with TMC OA will undergo a single face-to-face comprehensive assessment using a cross-sectional design. The assessment battery is structured according to the ICF framework and covers five domains: (a) Body Structure/Function: pain, joint mobility, grip and pinch strength, joint stability, and OA staging; (b) Activity: daily activity limitations and pain-activity patterns (avoidance, overdoing, pacing); (c) Participation: social, domestic, and occupational participation; (d) Personal Factors: pain beliefs, coping strategies, kinesiophobia, anxiety, and depression; (e) Environmental Factors: family support and ergonomic adaptations.

Work Package 2 (Comparison of Large Language Models' Clinical Knowledge Performance): Four large language models (Claude, ChatGPT, Gemini, LLaMA) will be queried with questions frequently encountered in the TMC OA domain. Responses will be evaluated by subject matter experts using five criteria: accuracy, reproducibility (same questions repeated two times), comprehensiveness, clinical relevance, and readability (health literacy appropriateness).

Work Package 3 (LLM-Based Predictive Profile Modeling): The best-performing LLM identified in WP2 will be provided with core clinical predictors from WP1 data. The model's predictions for multidimensional ICF-based patient profiles will be compared against actual assessment results using established agreement and performance metrics.

Sample size: Based on a priori power analysis (alpha=0.05, power=0.80, effect size=0.131), a minimum of 93 participants is required.

Первичные конечные точки

• Grip Strength [Срок оценки: Baseline (single assessment at enrollment)]
• Pinch Strength [Срок оценки: Baseline (single assessment at enrollment)]
• Thumb Opposition (Kapandji Score) [Срок оценки: Baseline (single assessment at enrollment)]
• Pain Intensity [Срок оценки: Baseline (single assessment at enrollment)]
• Pain Duration [Срок оценки: Baseline (single assessment at enrollment)]
• Radiographic Severity (Eaton-Littler Stage) [Срок оценки: Baseline (single assessment at enrollment)]
• Radial Subluxation Ratio [Срок оценки: Baseline (single assessment at enrollment)]
• Upper Extremity Disability (QuickDASH) [Срок оценки: Baseline (single assessment at enrollment)]
• Hand Disability (Turkish Thumb Disability Index - TDX) [Срок оценки: Baseline (single assessment at enrollment)]
• Joint Hypermobility (Beighton Score) [Срок оценки: Baseline (single assessment at enrollment)]

Вторичные конечные точки (5)

• Correlations Between Pain-Activity Patterns and Clinical Variables [Срок оценки: Baseline (single assessment at enrollment)]
• Kinesiophobia Level (Tampa Kinesiophobia Scale) [Срок оценки: Baseline (single assessment at enrollment).]
• Pain Beliefs Profile (Pain Beliefs Questionnaire) [Срок оценки: Baseline (single assessment at enrollment)]
• Anxiety and Depression (Hospital Anxiety and Depression Scale) [Срок оценки: Baseline (single assessment at enrollment).]
• Pain Coping Strategies (Pain Coping Questionnaire) [Срок оценки: Baseline (single assessment at enrollment)]

Критерии участия

Критерии включения

• Diagnosis of trapeziometacarpal osteoarthritis (TMC OA) confirmed by an orthopedic surgeon and/or hand surgeon
• TMC OA-related symptoms persisting for more than 3 months
• Aged between 25 and 74 years
• Literate in Turkish
• Adequate cognitive function (Mini-Mental State Examination score of 25 or above)
• No other chronic systemic disease (e.g., rheumatoid arthritis, chronic diabetes, cardiovascular disease, chronic hepatitis)
• Voluntary participation with signed informed consent

Критерии исключения

• Unwillingness to participate
• Presence of a different orthopedic condition or prior surgery involving the thumb on the unilateral upper extremity
• Uncontrolled systemic diseases (chronic obstructive pulmonary disease, congestive heart failure, endocrine system disease, history of stroke)
• Diagnosis of any major psychopathology and currently receiving psychiatric or psychological treatment
• Pregnancy

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Turkey (Türkiye) · 1 центр

• Hacettepe University, Faculty of Physical Therapy and Rehabilitation, Hand Surgery Rehabil — Ankara

Идентификаторы

NCT: NCT07458971 · FTREK25/168

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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