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Management Concepts of Metabolic Dysfunction Associated Steatotic Liver Disease (MASLD) Among Chinese Physicians

2026年6月26日 更新者:Novo Nordisk A/S

Attitudes, Perceptions, Clinical Practice, and Barriers in Diagnosis and Management of Patients With Metabolic Dysfunction-associated Steatotic Liver Disease: a Cross-sectional Survey on Physicians in China

This study is a cross-sectional survey-based study. The main goal of this study is to investigate the attitudes, perceptions, and clinical practice in assessing liver fibrosis following a metabolic dysfunction-associated steatotic liver disease (MASLD) diagnosis, and the management of MASLD patients among Chinese physicians in the departments of endocrinology / hepatology / infection / gastroenterology in Grade IIIA hospitals in provincial capitals or municipalities.

調査の概要

状態

募集

条件

研究の種類

観察的

入学 (推定)

470

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。

研究連絡先

研究場所

      • Beijing、中国
        • 募集
        • Novo Nordisk Investigational Site

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

はい

サンプリング方法

非確率サンプル

調査対象母集団

Physicians from department of endocrinology, hepatology, gastroenterology, department of infectious diseases, and from Grade IIIA hospitals located in provincial capitals will be enrolled to take the survey.

説明

Inclusion Criteria:

  • Has provided informed consent.
  • Registered clinical practice location in provincial capital or municipality.
  • Physician with a license for clinical practice.
  • Employed in the Department of Endocrinology, Hepatology, Infection or Gastroenterology.
  • Hospital level: Grade IIIA hospital.
  • Hold a professional title of associate chief physician or above, or senior attending physician (as an attending physician for more than or equal to (≥) 3 years).
  • Conducts outpatient clinics for at least 1 half-days per week.
  • The patient load of MASLD/MASH per month in the department should be:
  • a. Endocrinology ≥20 patients per month
  • b. Hepatology/Gastroenterology/ Infectious ≥30 patients per month

Exclusion Criteria:

-Participants will be excluded if they have unwillingness precluding adequate cooperation, fail to complete the questionnaire, or submit questionnaires verified as invalid.

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

コホートと介入

グループ/コホート
介入・治療
Physicians treating MASLD
The survey will be conducted via 15-minute online questionnaire survey of 30 specialists in the departments of endocrinology, hepatology, infection, and gastroenterology.
This study is a cross-sectional survey-based study. The design is observational and descriptive. Collection of data will be performed via a quantitative online survey.

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
To investigate attitudes and perceptions concerning the reasons for further severity assessment (mainly refers to the assessment of liver fibrosis) following a MASLD diagnosis
時間枠:At the data capture (Day 1)

The reason for severity assessment will be measured via questionnaires. The corresponding questionnaire items were designed to explore whether physicians would conduct further evaluation for patients diagnosed with MASLD and what dimensions such further evaluation would cover. Details of the questions are shown below:

  1. For patients with confirmed MASLD, will you perform additional diagnostic evaluation? (Single choice)

    • Yes, I will conduct subsequent assessment and risk stratification
    • No, a confirmed MASLD diagnosis is sufficient.
  2. For physicians who selected "Yes": What dimensions will your additional diagnostic evaluation cover? (Multiple choices)

    • Rule out other liver diseases
    • Assess metabolic comorbidities and risk factors
    • Identify whether the patient has concurrent MASH
    • Determine the stage of liver fibrosis
    • Others, please specify
At the data capture (Day 1)
Methods used for diagnose liver fibrosis
時間枠:At the data capture (Day 1)

Methods used for liver fibrosis diagnosis will be assessed via questionnaires. The corresponding questionnaire items asked physicians to select the examinations they use to assess the stage of liver fibrosis in patients with MASLD.

For physicians who perform liver fibrosis staging: Among patients with confirmed MASLD, which of the following tools do you use in routine clinical practice to evaluate liver fibrosis stage? Available response options include FibroScan, FibroTouch, Magnetic Resonance Elastography (MRE), fibrosis-specific serological tests (e.g., PIIINP, C-IV, LN, HA), simple scoring systems (e.g., FIB-4, NFS, APRI), and others (please specify).

At the data capture (Day 1)
To find percentages of patients who undergo different liver fibrosis examination
時間枠:At the data capture (Day 1)

Percentages of patients who undergo different liver fibrosis examination will be measured via questionnaires. The corresponding questionnaire items asked physicians to report the proportion of patients with MASLD for whom they utilize each liver fibrosis assessment method in routine clinical practice.

For each selected examination tool, physicians report the proportion of patients receiving the test in their daily clinical work using predefined categories (≤10%, 10%-25%, 25%-50%, 50%-75%, and 75%-100%).

At the data capture (Day 1)
To find reasons for insufficient liver fibrosis assessment
時間枠:At the data capture (Day 1)

This will be assessed via questionnaires. The corresponding questionnaire items investigate whether physicians believe there is insufficient liver fibrosis assessment in current clinical practice. Those who answer affirmatively are then asked to select contributing factors.

For patients with confirmed MASLD, physicians are asked: do you think liver fibrosis assessment is currently inadequate in clinical practice? If yes, what are the leading causes of insufficient fibrosis evaluation? Physicians can select from predefined causes, including clinicians paying insufficient attention to liver fibrosis evaluation, low patient acceptance rate of liver biopsy, low diagnostic accuracy of existing noninvasive fibrosis assessment tools, lack of effective pharmacotherapies for liver fibrosis, and others (please specify). There is also an option indicating that there is no inadequate liver fibrosis assessment in clinical practice, which is mutually exclusive with the other options.

At the data capture (Day 1)
To investigate importance order of the reasons for insufficient liver fibrosis assessment
時間枠:At the data capture (Day 1)

This will be measured via questionnaires. The corresponding questionnaire items investigate whether physicians believe there is insufficient liver fibrosis assessment in current clinical practice. Those who answer affirmatively are then asked to rank the contributing factors in order of importance.

For the selected causes of insufficient fibrosis evaluation, physicians rank each factor based on its importance in contributing to inadequate liver fibrosis assessment in clinical practice.

At the data capture (Day 1)

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

捜査官

  • スタディディレクター:Clinical Transparency (dept. 2834)、Novo Nordisk A/S

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3日

一次修了 (推定)

2027年2月23日

研究の完了 (推定)

2027年2月23日

試験登録日

最初に提出

2026年6月11日

QC基準を満たした最初の提出物

2026年6月26日

最初の投稿 (実際)

2026年7月2日

学習記録の更新

投稿された最後の更新 (実際)

2026年7月2日

QC基準を満たした最後の更新が送信されました

2026年6月26日

最終確認日

2026年6月1日

詳しくは

本研究に関する用語

追加の関連 MeSH 用語

その他の研究ID番号

  • DAS-8853
  • U1111-1336-6265 (その他の識別子:World Health Organization (WHO))

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?

はい

IPD プランの説明

According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

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

いいえ

米国FDA規制機器製品の研究

いいえ

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