Roland von Känel, Stefan Neuner-Jehle, Reto W Kressig, Idris Guessous, Pierre Alexandre Krayenbühl, Lukas Zimmerli, Anne Angelilo-Scherer, Thomas Keller, Caroline Elzner, Karl Pauls, Neige Morin, Edouard Battegay
{"title":"一种新的鉴别诊断对管理初级保健中不明原因疲劳患者的影响:一项前瞻性、随机、对照、开放和多中心的初级保健研究。","authors":"Roland von Känel, Stefan Neuner-Jehle, Reto W Kressig, Idris Guessous, Pierre Alexandre Krayenbühl, Lukas Zimmerli, Anne Angelilo-Scherer, Thomas Keller, Caroline Elzner, Karl Pauls, Neige Morin, Edouard Battegay","doi":"10.1186/s12875-025-02873-3","DOIUrl":null,"url":null,"abstract":"<p><strong>Aims of the study: </strong>Unexplained fatigue is a common reason for encounters in primary care. However, currently no aid orients physicians in detecting its potential causes. The aim of this study was to evaluate whether the novel Fatigue Differential Diagnostic Aid (FDDA) supported clinicians in better managing unexplained fatigue.</p><p><strong>Methods: </strong>This was a prospective, cluster-randomized, controlled, open, and multicenter study comparing the use of the FDDA vs usual care in patients with unexplained fatigue as the main reason for encounter. The primary endpoint was difference in Patient Global Impression of Change (PGIC) between groups at 3 months. Among pre-defined secondary endpoints were: Difference in change of PGIC between groups at 6 months; percentage of patients with fatigue reduction; mean reduction in fatigue; clinician's confidence in diagnosis; patient satisfaction with quality of care (diagnostic process and treatment); number of clinician-reported visits; number of referrals to specialists; and time until final diagnosis.</p><p><strong>Results: </strong>112 primary care practitioners (PCPs) recruited in Switzerland between 2017 to 2020 were randomly cluster-assigned to the FDDA = 57 or usual care = 55 arm. Of these, 15 (FDDA) and 22 (usual care) PCPs recruited 93 patients (FDDA: n = 40, usual care: n = 53). The achieved sample size was less than planned. There was no difference in PGIC at 3 months between groups (D = 0.06, 95%-CI: -0.41 - -0.53, p = 0.802). Among secondary endpoints, no significant differences occurred in PGIC at 6 months, nor in fatigue reduction. However, in the FDDA group, more patients reported less fatigue at 3 or 6 months (D = 18.9%, 95%-CI: -33.6 - -4.3%, p = 0.011), and increased satisfaction with treatment management at 1 month (FDDA 56.8% vs usual care 25.0%, p = 0.004) and 3 months (FDDA 64.9% vs usual care 31.0%, p = 0.003); the FDDA was also associated with higher total number of visits (median 4.0 vs 3.0, p < 0.001).</p><p><strong>Conclusions: </strong>In this pilot study, the FDDA, a structured diagnostic aid for guiding PCPs in identifying the causes of unexplained fatigue in their patients, was not able to show a global improvement in patient outcomes despite improvements in fatigue and satisfaction with care. The evaluation of fatigue in larger-scale studies is warranted.</p><p><strong>Trial registration: </strong>This trial was retrospectively registered on ClinicalTrials.gov.</p><p><strong>Trial registration number: </strong> NCT05861492. Date of registration: 17th May 2023. The ethics committee of Ethikkommission Nordwest- und Zentralschweiz (EKNZ) had originally voiced the opinion that no registration was required because no drug or intervention was involved, i.e., the study was non-interventional and observational. However, the study authors felt that the study should be retrospectively registered because the FDDA could be interpreted to be an active intervention. At the time of registration, two protocol deviations occurred that are explicitly addressed in the Methods section of this manuscript. Because of the low sample size, we statistically compared \"patients\" instead of \"comparing patients nested in doctors\" (the latter was performed as an additional analysis). Thus, cluster randomization was performed, but the analysis to consider this was not feasible.</p>","PeriodicalId":72428,"journal":{"name":"BMC primary care","volume":"26 1","pages":"183"},"PeriodicalIF":2.6000,"publicationDate":"2025-05-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12102925/pdf/","citationCount":"0","resultStr":"{\"title\":\"Effects of a novel differential diagnosis aid for managing patients with unexplained fatigue in primary care: a prospective randomized, controlled, open and multicenter study in primary care.\",\"authors\":\"Roland von Känel, Stefan Neuner-Jehle, Reto W Kressig, Idris Guessous, Pierre Alexandre Krayenbühl, Lukas Zimmerli, Anne Angelilo-Scherer, Thomas Keller, Caroline Elzner, Karl Pauls, Neige Morin, Edouard Battegay\",\"doi\":\"10.1186/s12875-025-02873-3\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Aims of the study: </strong>Unexplained fatigue is a common reason for encounters in primary care. However, currently no aid orients physicians in detecting its potential causes. The aim of this study was to evaluate whether the novel Fatigue Differential Diagnostic Aid (FDDA) supported clinicians in better managing unexplained fatigue.</p><p><strong>Methods: </strong>This was a prospective, cluster-randomized, controlled, open, and multicenter study comparing the use of the FDDA vs usual care in patients with unexplained fatigue as the main reason for encounter. The primary endpoint was difference in Patient Global Impression of Change (PGIC) between groups at 3 months. Among pre-defined secondary endpoints were: Difference in change of PGIC between groups at 6 months; percentage of patients with fatigue reduction; mean reduction in fatigue; clinician's confidence in diagnosis; patient satisfaction with quality of care (diagnostic process and treatment); number of clinician-reported visits; number of referrals to specialists; and time until final diagnosis.</p><p><strong>Results: </strong>112 primary care practitioners (PCPs) recruited in Switzerland between 2017 to 2020 were randomly cluster-assigned to the FDDA = 57 or usual care = 55 arm. Of these, 15 (FDDA) and 22 (usual care) PCPs recruited 93 patients (FDDA: n = 40, usual care: n = 53). The achieved sample size was less than planned. There was no difference in PGIC at 3 months between groups (D = 0.06, 95%-CI: -0.41 - -0.53, p = 0.802). Among secondary endpoints, no significant differences occurred in PGIC at 6 months, nor in fatigue reduction. However, in the FDDA group, more patients reported less fatigue at 3 or 6 months (D = 18.9%, 95%-CI: -33.6 - -4.3%, p = 0.011), and increased satisfaction with treatment management at 1 month (FDDA 56.8% vs usual care 25.0%, p = 0.004) and 3 months (FDDA 64.9% vs usual care 31.0%, p = 0.003); the FDDA was also associated with higher total number of visits (median 4.0 vs 3.0, p < 0.001).</p><p><strong>Conclusions: </strong>In this pilot study, the FDDA, a structured diagnostic aid for guiding PCPs in identifying the causes of unexplained fatigue in their patients, was not able to show a global improvement in patient outcomes despite improvements in fatigue and satisfaction with care. The evaluation of fatigue in larger-scale studies is warranted.</p><p><strong>Trial registration: </strong>This trial was retrospectively registered on ClinicalTrials.gov.</p><p><strong>Trial registration number: </strong> NCT05861492. Date of registration: 17th May 2023. 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引用次数: 0
摘要
研究目的:不明原因的疲劳是在初级保健遭遇的常见原因。然而,目前尚无指导医生检测其潜在原因的方法。本研究的目的是评估新的疲劳鉴别诊断辅助(FDDA)是否支持临床医生更好地管理不明原因的疲劳。方法:这是一项前瞻性、集群随机、对照、开放和多中心研究,比较了以不明原因疲劳为主要原因的患者使用fda和常规护理。主要终点是3个月时两组患者总体变化印象(PGIC)的差异。预先设定的次要终点包括:6个月时两组间PGIC变化的差异;患者疲劳减轻的百分比;平均减少疲劳;临床医师对诊断的信心;患者对护理质量的满意度(诊断过程和治疗);医生报告的就诊次数;转介给专科医生的次数;还有时间等待最终诊断。结果:2017年至2020年在瑞士招募的112名初级保健医生(pcp)被随机分组分配到FDDA = 57或常规护理= 55组。其中,15个(fda)和22个(常规护理)pcp招募了93例患者(fda: n = 40,常规护理:n = 53)。实现的样本量低于计划。3个月时各组PGIC无差异(D = 0.06, 95% ci: -0.41 - -0.53, p = 0.802)。在次要终点中,6个月时PGIC和疲劳减少没有显著差异。然而,在FDDA组中,更多的患者报告在3或6个月时疲劳减轻(D = 18.9%, 95% ci: -33.6 - -4.3%, p = 0.011),并且在1个月时(FDDA 56.8%比常规护理25.0%,p = 0.004)和3个月时(FDDA 64.9%比常规护理31.0%,p = 0.003)对治疗管理的满意度增加;FDDA也与更高的总就诊次数相关(中位数为4.0 vs 3.0, p)。结论:在这项试点研究中,FDDA是一种结构化的诊断辅助工具,用于指导pcp识别患者不明原因疲劳的原因,尽管在疲劳和护理满意度方面有所改善,但无法显示患者预后的整体改善。在大规模的研究中对疲劳进行评估是有必要的。试验注册:本试验回顾性注册在clinicaltrials .gov.试验注册号:NCT05861492。注册日期:2023年5月17日。西北和中央瑞士伦理委员会(EKNZ)的伦理委员会最初表示不需要注册,因为不涉及药物或干预措施,即该研究是非干预性和观察性的。然而,该研究的作者认为该研究应该进行回顾性登记,因为fda可以被解释为一种积极的干预。在注册时,发生了两个方案偏差,在本文的方法部分中明确指出。由于样本量小,我们在统计上比较“患者”,而不是“比较嵌套在医生中的患者”(后者作为附加分析进行)。因此,进行了聚类随机化,但考虑到这一点的分析是不可行的。
Effects of a novel differential diagnosis aid for managing patients with unexplained fatigue in primary care: a prospective randomized, controlled, open and multicenter study in primary care.
Aims of the study: Unexplained fatigue is a common reason for encounters in primary care. However, currently no aid orients physicians in detecting its potential causes. The aim of this study was to evaluate whether the novel Fatigue Differential Diagnostic Aid (FDDA) supported clinicians in better managing unexplained fatigue.
Methods: This was a prospective, cluster-randomized, controlled, open, and multicenter study comparing the use of the FDDA vs usual care in patients with unexplained fatigue as the main reason for encounter. The primary endpoint was difference in Patient Global Impression of Change (PGIC) between groups at 3 months. Among pre-defined secondary endpoints were: Difference in change of PGIC between groups at 6 months; percentage of patients with fatigue reduction; mean reduction in fatigue; clinician's confidence in diagnosis; patient satisfaction with quality of care (diagnostic process and treatment); number of clinician-reported visits; number of referrals to specialists; and time until final diagnosis.
Results: 112 primary care practitioners (PCPs) recruited in Switzerland between 2017 to 2020 were randomly cluster-assigned to the FDDA = 57 or usual care = 55 arm. Of these, 15 (FDDA) and 22 (usual care) PCPs recruited 93 patients (FDDA: n = 40, usual care: n = 53). The achieved sample size was less than planned. There was no difference in PGIC at 3 months between groups (D = 0.06, 95%-CI: -0.41 - -0.53, p = 0.802). Among secondary endpoints, no significant differences occurred in PGIC at 6 months, nor in fatigue reduction. However, in the FDDA group, more patients reported less fatigue at 3 or 6 months (D = 18.9%, 95%-CI: -33.6 - -4.3%, p = 0.011), and increased satisfaction with treatment management at 1 month (FDDA 56.8% vs usual care 25.0%, p = 0.004) and 3 months (FDDA 64.9% vs usual care 31.0%, p = 0.003); the FDDA was also associated with higher total number of visits (median 4.0 vs 3.0, p < 0.001).
Conclusions: In this pilot study, the FDDA, a structured diagnostic aid for guiding PCPs in identifying the causes of unexplained fatigue in their patients, was not able to show a global improvement in patient outcomes despite improvements in fatigue and satisfaction with care. The evaluation of fatigue in larger-scale studies is warranted.
Trial registration: This trial was retrospectively registered on ClinicalTrials.gov.
Trial registration number: NCT05861492. Date of registration: 17th May 2023. The ethics committee of Ethikkommission Nordwest- und Zentralschweiz (EKNZ) had originally voiced the opinion that no registration was required because no drug or intervention was involved, i.e., the study was non-interventional and observational. However, the study authors felt that the study should be retrospectively registered because the FDDA could be interpreted to be an active intervention. At the time of registration, two protocol deviations occurred that are explicitly addressed in the Methods section of this manuscript. Because of the low sample size, we statistically compared "patients" instead of "comparing patients nested in doctors" (the latter was performed as an additional analysis). Thus, cluster randomization was performed, but the analysis to consider this was not feasible.