biostudies-literatureHebestreit HGerman InnovationsfondUniversitätsklinikum Würzburg47https://www.ebi.ac.uk/biostudies/studies/S-EPMC8842899biostudies-literatureUnknown17(1)<h4>Background</h4>In individuals suffering from a rare disease the diagnostic process and the confirmation of a final diagnosis often extends over many years. Factors contributing to delayed diagnosis include health care professionals' limited knowledge of rare diseases and frequent (co-)occurrence of mental disorders that may complicate and delay the diagnostic process. The ZSE-DUO study aims to assess the benefits of a combination of a physician focusing on somatic aspects with a mental health expert working side by side as a tandem in the diagnostic process.<h4>Study design</h4>This multi-center, prospective controlled study has a two-phase cohort design.<h4>Methods</h4>Two cohorts of 682 patients each are sequentially recruited from 11 university-based German Centers for Rare DiseasesOrphanet journal of rare diseasesDual guidance structure for evaluation of patients with unclear diagnosis in centers for rare diseases (ZSE-DUO): study protocol for a controlled multi-center cohort study.PMC884289901NVF17031Heuschmann PFrommer JHennermann JWeiler CZeidler COtt SHaas AQuitmann JPfister LHebestreit HHaas KBlomeke JSpangenberger AGlode ALatzko PBerger ABabka CDieris-Hirche JZenker KSchippers CGreger HSelig USchulz JBBohm LBrinkmann FWalter SRomanos MHilbig BVolk DDebatin KMKrassort HSchaubert KSchoels LBerneburg MHerpertz SSteinbuchel TGundel HMusacchio TStosser Sde Zwaan Mde Greck MRieß OCeliker MImhof CLucke TTuscher OBritz VUngethum KRampp CZhang KDHolthofer LBrandstetter LVogel MEymann JSchneider SGrasemann CDeibele AKratz CPetermann-Meyer AKassubek JDillmann-Jehn KJunne FLoew THerrmann-Werner ASuchant SKoschitzki KTGodecke VMundlos CEttinger MSchmidt AVollmuth CMuller SJacob TBullinger MBottger BZajt KKMaisch TNießen MMeyer TSchubert KGabrian MHaisch LZSE-DUO working groupGraessner HZipfel SBraun BRutsch FKuhn JKristensen KGrauer EHaase MKrauth CNohre MSroka ACario HDeckert JAkkaya FBarlescu LDos Santos IMWarrings BBarsch-Michelmann AKropff BMohnike KErtl MWagner TOFLudolph ACWitt SHeuft GHeld MRichter ANanciu ANPfeifer-Duck CZeltner LKick LKarl SHett JSchweiger SPapagianni AHeinrich ILapstich AMMonninger MVolnov SPiduhn LSBergbreiter ASchwalba MLorenz DfalseDual guidance structure for evaluation of patients with unclear diagnosis in centers for rare diseases (ZSE-DUO): study protocol for a controlled multi-center cohort study.<h4>Background</h4>In individuals suffering from a rare disease the diagnostic process and the confirmation of a final diagnosis often extends over many years. Factors contributing to delayed diagnosis include health care professionals' limited knowledge of rare diseases and frequent (co-)occurrence of mental disorders that may complicate and delay the diagnostic process. The ZSE-DUO study aims to assess the benefits of a combination of a physician focusing on somatic aspects with a mental health expert working side by side as a tandem in the diagnostic process.<h4>Study design</h4>This multi-center, prospective controlled study has a two-phase cohort design.<h4>Methods</h4>Two cohorts of 682 patients each are sequentially recruited from 11 university-based German Centers for Rare Diseases2022-01-01T00:00:00Z2022 Feb2025-04-26T09:46:33.249Z2024-11-19T21:52:44.667ZS-EPMC88428993516480410.1186/s13023-022-02176-1