疼痛医学デジタルワークフローアルゴリズムの検証と評価（PGS 1.0）
疼痛医学デジタルワークフローのアルゴリズムの前向き検証とパフォーマンス評価（PGS 1.0）
This is a prospective, non-randomized, double blind, single center, single arm, validation study, to evaluate the performance of PGS 1.0 algorithm in analyzing pain specific symptoms and medical history data of pain patients referred to a pain expert consultation.
調査の概要
状態
条件
詳細な説明
Background and Rationale:
Chronic pain is a global epidemic. On average, 20% of the Western population suffers from chronic pain, and in some countries, such as the U.S., the number reaches up to 30%. When chronic pain is not properly diagnosed and treated, it leads not only to patient suffering but also to serious comorbidities, increased use of healthcare services, and, in growing numbers, addiction and misuse of prescription drugs.
Pain medicine, a relatively young medical field, offers evidence-based diagnosis and treatment tailored to the patient's pain mechanisms. However, there is a major gap between the large number of patients and the very limited number of pain specialists (around 4,000 in the U.S. and about 80 in Israel). This shortage leads to extremely long waiting times (5-6 months) while patients continue to suffer.
To help close this gap, PG Medical Systems, together with Dr. Simon Wolfson (Head of the Pain Institute at Rambam Health Care Campus), developed an algorithm that analyzes patient symptoms and provides recommendations for pain diagnosis and treatment pathways.
Study Objective:
The study aims to prospectively validate the algorithm's performance by collecting patient data via an online questionnaire at the Rambam Pain Institute. The results will compare the algorithm's diagnoses to those of pain specialists.
Study Procedures:
Patients visiting the Rambam Pain Institute (first-time or follow-up appointments) will be invited to join the study. After signing informed consent, they will complete an online questionnaire with the help of a research assistant. This is a one-time activity, following their medical consultation. The study does not involve additional clinical follow-up. Participation will not affect the patient's diagnosis or treatment.
Duration:
Each participant will spend about 45-60 minutes, including the consent process and questionnaire completion.
Compensation:
Participants will receive 100 NIS for their time.
Data Management and Privacy:
The study will collect only non-identifiable patient data. Each participant will be assigned a code number. Identifying details will remain securely stored at Rambam, linked only by the consent form. This allows for possible follow-up research but ensures that the sponsor company has access only to de-identified data.
Data Security:
All data is stored on Amazon's secure cloud with advanced encryption. Access requires strict authentication, servers are closed to public internet, and only approved private networks can connect. All data is encrypted in transfer and storage. Importantly, the system does not collect identifiable patient information.
研究の種類
入学 (推定)
連絡先と場所
研究連絡先
- 名前：Shany Blum, MD PhD
- 電話番号：+972545331773
- メール：shany@pgmeds.com
研究場所
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Haifa、イスラエル、31906
- 募集
- Pain Medicine Institute, Rambam Health Care Campus
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主任研究者：
- Simon Vulfsons, MD
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コンタクト：
- May Haddad, PhD
- 電話番号：+97247772166
- メール：ma_haddad@rambam.health.gov.il
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副調査官：
- Amir Minerbi, MD PhD
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
Male and Female patients aged 18-80, consecutively all patients referred to a pain expert.
説明
Inclusion Criteria:
- Patient is willing and capable of providing Informed Consent.
- Pain persisting for at least 1 month.
Exclusion Criteria:
None
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
- 観測モデル：CASE_ONLY
- 時間の展望：PROSPECTIVE
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 |
|---|---|---|
|
Agreement by percent agreement
時間枠：At the completion of patients' enrollment, agreement will be assessed between PGS 1.0 diagnosis and the expert diagnosis per patient (diagnosis of expert at the intake to the pain clinic and PGS 1.0 diagnosis as per the data the patient filled in).
|
Interrater reliability defined as the agreement between the PGS 1.0 algorithm and Pain Expert in rating pain patients' pain diagnosis as measured by percent agreement. |
At the completion of patients' enrollment, agreement will be assessed between PGS 1.0 diagnosis and the expert diagnosis per patient (diagnosis of expert at the intake to the pain clinic and PGS 1.0 diagnosis as per the data the patient filled in).
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Agreement by Cohen's Kappa coefficient.
時間枠：At the completion of patients' enrollment, agreement will be assessed between PGS 1.0 diagnosis and the expert diagnosis per patient (diagnosis of expert at the intake to the pain clinic and PGS 1.0 diagnosis as per the data the patient filled in).
|
Interrater reliability defined as the agreement between the PGS 1.0 algorithm and Pain Expert in rating pain patients' diagnosis as measured by Cohen's Kappa coefficient. |
At the completion of patients' enrollment, agreement will be assessed between PGS 1.0 diagnosis and the expert diagnosis per patient (diagnosis of expert at the intake to the pain clinic and PGS 1.0 diagnosis as per the data the patient filled in).
|
協力者と研究者
スポンサー
捜査官
- 主任研究者：Simon Vulfsons, MD、Rambam Health Care Campus
研究記録日
主要日程の研究
研究開始 (実際)
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
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。