Early identification of functional somatic disorders in an internal medicine diagnostic clinic: The DISTRESS trial

IF 1.9 3区医学 Q3 MEDICINE, RESEARCH & EXPERIMENTAL

Contemporary clinical trials Pub Date : 2025-09-17 DOI:10.1016/j.cct.2025.108082

Michael M. Madsen , Christian Trolle , Lotte V. Fynne , Michele Colombo , Rasmus L. Pedersen , Vibeke N. Sørensen , Susan R. Christensen , Per Fink , Lise K. Gormsen

{"title":"Early identification of functional somatic disorders in an internal medicine diagnostic clinic: The DISTRESS trial","authors":"Michael M. Madsen , Christian Trolle , Lotte V. Fynne , Michele Colombo , Rasmus L. Pedersen , Vibeke N. Sørensen , Susan R. Christensen , Per Fink , Lise K. Gormsen","doi":"10.1016/j.cct.2025.108082","DOIUrl":null,"url":null,"abstract":"<div><h3>Background</h3><div>Functional Somatic Disorders (FSDs) affect approximately 10 % of the general population (1) and often lead to reduced quality of life, extensive diagnostic evaluations and increased healthcare costs. The DISTRESS (Diagnostic Intervention in Secondary care Targeting patients Referred for Evaluation of bodily Stress Symptoms) trial protocol describes a randomised clinical trial evaluating a novel FSD Diagnostic Clinic, with the aim of providing early diagnosis and thereby helping patients and clinicians bring the diagnostic odyssey to a definitive and meaningful conclusion.</div></div><div><h3>Methods/design</h3><div>This pragmatic, randomised trial employs allocation concealment and blinded outcome assessment, although the randomisation allocation is unavoidably unmasked to patients and clinicians due to the nature of the intervention. Patients with suspected FSD are randomised 1:1 to either the FSD Diagnostic Clinic, where internal medicine specialists (internists) undertake the FSD diagnostic process, or to usual diagnostic assessment. The two co-primary outcomes evaluate (a) healthcare utilization and (b) costs-effectiveness, assessed alongside health-related quality of life measured by the SF-36 survey at 12 months post-intervention. Secondary outcomes include relevant clinical outcomes and overall public expenses.</div></div><div><h3>Discussion</h3><div>The DISTRESS trial addresses challenges in diagnosing FSDs by evaluating a novel Diagnostic Clinic model and its impact on patient outcomes, cost-effectiveness, and healthcare utilization. Insights from separately conducted qualitative studies will complement the trial by assessing the clinic's acceptability and integration within the healthcare system. By training internists to diagnose and manage FSDs using approaches typically employed by FSD specialists, the FSD Diagnostic Clinic expands access to timely care within a stepped care model.</div></div><div><h3>Trial Registration</h3><div><span><span>ClinicalTrials.gov</span><svg><path></path></svg></span> Identifier: <span><span>NCT06025617</span><svg><path></path></svg></span></div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"158 ","pages":"Article 108082"},"PeriodicalIF":1.9000,"publicationDate":"2025-09-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Contemporary clinical trials","FirstCategoryId":"3","ListUrlMain":"https://www.sciencedirect.com/science/article/pii/S1551714425002769","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q3","JCRName":"MEDICINE, RESEARCH & EXPERIMENTAL","Score":null,"Total":0}

引用次数: 0

Abstract

Background

Functional Somatic Disorders (FSDs) affect approximately 10 % of the general population (1) and often lead to reduced quality of life, extensive diagnostic evaluations and increased healthcare costs. The DISTRESS (Diagnostic Intervention in Secondary care Targeting patients Referred for Evaluation of bodily Stress Symptoms) trial protocol describes a randomised clinical trial evaluating a novel FSD Diagnostic Clinic, with the aim of providing early diagnosis and thereby helping patients and clinicians bring the diagnostic odyssey to a definitive and meaningful conclusion.

Methods/design

This pragmatic, randomised trial employs allocation concealment and blinded outcome assessment, although the randomisation allocation is unavoidably unmasked to patients and clinicians due to the nature of the intervention. Patients with suspected FSD are randomised 1:1 to either the FSD Diagnostic Clinic, where internal medicine specialists (internists) undertake the FSD diagnostic process, or to usual diagnostic assessment. The two co-primary outcomes evaluate (a) healthcare utilization and (b) costs-effectiveness, assessed alongside health-related quality of life measured by the SF-36 survey at 12 months post-intervention. Secondary outcomes include relevant clinical outcomes and overall public expenses.

Discussion

The DISTRESS trial addresses challenges in diagnosing FSDs by evaluating a novel Diagnostic Clinic model and its impact on patient outcomes, cost-effectiveness, and healthcare utilization. Insights from separately conducted qualitative studies will complement the trial by assessing the clinic's acceptability and integration within the healthcare system. By training internists to diagnose and manage FSDs using approaches typically employed by FSD specialists, the FSD Diagnostic Clinic expands access to timely care within a stepped care model.

Trial Registration

ClinicalTrials.gov Identifier: NCT06025617

查看原文本刊更多论文

内科诊断诊所功能性躯体疾病的早期识别：窘迫试验。

背景：功能性躯体疾病（FSDs）影响大约10% %的普通人群(1)，并经常导致生活质量下降、广泛的诊断评估和医疗保健费用增加。“窘迫”（二级医疗诊断干预，针对接受身体应激症状评估的患者）试验方案描述了一项随机临床试验，评估一种新的FSD诊断诊所，目的是提供早期诊断，从而帮助患者和临床医生将诊断过程得出明确而有意义的结论。方法/设计：这项实用的随机试验采用分配隐藏和盲法结果评估，尽管由于干预的性质，患者和临床医生不能盲法。怀疑患有消防处性功能障碍的病人按1:1的比例随机分配到消防处诊断诊所，由内科专家（内科医生）进行消防处诊断程序，或接受常规诊断评估。两个共同主要结局评估(a)医疗保健利用和(b)成本效益，同时在干预后12 个月通过SF-36调查测量健康相关生活质量。次要结局包括相关临床结局和总体公共支出。讨论：DISTRESS试验通过评估一种新的诊断临床模型及其对患者预后、成本效益和医疗保健利用的影响，解决了诊断fsd的挑战。单独进行的定性研究的见解将通过评估诊所的可接受性和医疗保健系统内的整合来补充试验。通过培训内科医生使用消防处专家通常采用的方法诊断和管理消防处疾病，消防处诊断诊所在阶梯式护理模式下扩大了获得及时护理的机会。试验注册：ClinicalTrials.gov标识符：NCT06025617。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

求助全文

约1分钟内获得全文求助全文

来源期刊

Contemporary clinical trials 医学-药学

CiteScore

3.70

自引率

4.50%

发文量

281

审稿时长

44 days

期刊介绍： Contemporary Clinical Trials is an international peer reviewed journal that publishes manuscripts pertaining to all aspects of clinical trials, including, but not limited to, design, conduct, analysis, regulation and ethics. Manuscripts submitted should appeal to a readership drawn from disciplines including medicine, biostatistics, epidemiology, computer science, management science, behavioural science, pharmaceutical science, and bioethics. Full-length papers and short communications not exceeding 1,500 words, as well as systemic reviews of clinical trials and methodologies will be published. Perspectives/commentaries on current issues and the impact of clinical trials on the practice of medicine and health policy are also welcome.