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

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.

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Publication Details

Journal
BMC Primary Care
Published
2025-05-24
DOI
https://doi.org/10.1186/s12875-025-02873-3
Primary Topic
Fibromyalgia and Chronic Fatigue Syndrome Research
Type
article
Field-Weighted Citation Impact
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article

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

Caroline Elzner, Thomas Keller, Lukas Zimmerli, Roland von Känel et al.
BMC Primary Care
Fibromyalgia and Chronic Fatigue Syndrome Research
article

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

Caroline Elzner, Thomas Keller, Lukas Zimmerli, Roland von Känel, Stefan Neuner‐Jehle, Reto W. Kressig, Idris Guessous, Anne Angelilo-Scherer, Edouard Battegay, Neige Morin, Pierre Krayenbühl, Karl Pauls
article en

Abstract

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.

BMC Primary CareVol. 26(1)
Statistisches Bundesamt (DE), University of Zurich (CH), University Hospital of Basel (CH), International Longevity Centre (GB), University Hospital of Zurich (CH), Vifor Pharma (Switzerland) (CH), University Hospital of Geneva (CH), Felix Platter-Hospital (CH), Solothurner Spitäler (CH), Kantonsschule Olten (CH), Spital Uster (CH), Berlin Center for Epidemiology and Health Research (DE)
Openalex Percentile: Top 86%
Fibromyalgia and Chronic Fatigue Syndrome Research
DOIOpen Access PDFOpenAlex
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