OBJECTIVE: Using different criteria for classifying patients into various stages of a disease can modify the stage-specific prognosis, even though the overall disease course remains unchanged. This is known as the "Will Rogers phenomenon," precluding the use of historical controls for treatment trials. We assessed whether the Will Rogers phenomenon may affect multiple sclerosis (MS) prognosis when applying different diagnostic criteria. METHODS: Patients with a clinically isolated syndrome (CIS) suggestive of MS were studied. After 1 year, each patient was classified as CIS or evolved to MS according to two diagnostic criteria (Poser and McDonald). The outcome for prognosis was the time to reach an Expanded Disability Status Scale score > or = 3.0. RESULTS: 309 patients were studied for a median period of 84 months. After 1 year, 16% of patients had MS according to Poser and 44% according to McDonald criteria. The probability to reach Expanded Disability Status Scale score > or = 3.0 at median follow-up was 11% in CIS patients according to Poser and 7% according to McDonald criteria; it was 46% in MS patients according to Poser and 27% acccording to McDonald criteria. The group with a discordant diagnosis had a worse prognosis than that of CIS patients according to both criteria (p = 0.01), but better than that of MS patients according to both criteria (p = 0.01). INTERPRETATION: The use of different diagnostic criteria may generate spurious improvements in the medium-term prognosis of MS. This calls for caution in using historical controls for MS trials.
OBJECTIVE: Using different criteria for classifying patients into various stages of a disease can modify the stage-specific prognosis, even though the overall disease course remains unchanged. This is known as the "Will Rogers phenomenon," precluding the use of historical controls for treatment trials. We assessed whether the Will Rogers phenomenon may affect multiple sclerosis (MS) prognosis when applying different diagnostic criteria. METHODS:Patients with a clinically isolated syndrome (CIS) suggestive of MS were studied. After 1 year, each patient was classified as CIS or evolved to MS according to two diagnostic criteria (Poser and McDonald). The outcome for prognosis was the time to reach an Expanded Disability Status Scale score > or = 3.0. RESULTS: 309 patients were studied for a median period of 84 months. After 1 year, 16% of patients had MS according to Poser and 44% according to McDonald criteria. The probability to reach Expanded Disability Status Scale score > or = 3.0 at median follow-up was 11% in CIS patients according to Poser and 7% according to McDonald criteria; it was 46% in MS patients according to Poser and 27% acccording to McDonald criteria. The group with a discordant diagnosis had a worse prognosis than that of CIS patients according to both criteria (p = 0.01), but better than that of MS patients according to both criteria (p = 0.01). INTERPRETATION: The use of different diagnostic criteria may generate spurious improvements in the medium-term prognosis of MS. This calls for caution in using historical controls for MS trials.
Authors: Roos M van der Vuurst de Vries; Julia Y Mescheriakova; Yu Yi M Wong; Tessel F Runia; Naghmeh Jafari; Johnny P Samijn; Janet W K de Beukelaar; Beatrijs H A Wokke; Theodora A M Siepman; Rogier Q Hintzen Journal: JAMA Neurol Date: 2018-11-01 Impact factor: 18.302
Authors: J William L Brown; Alasdair Coles; Dana Horakova; Eva Havrdova; Guillermo Izquierdo; Alexandre Prat; Marc Girard; Pierre Duquette; Maria Trojano; Alessandra Lugaresi; Roberto Bergamaschi; Pierre Grammond; Raed Alroughani; Raymond Hupperts; Pamela McCombe; Vincent Van Pesch; Patrizia Sola; Diana Ferraro; Francois Grand'Maison; Murat Terzi; Jeannette Lechner-Scott; Schlomo Flechter; Mark Slee; Vahid Shaygannejad; Eugenio Pucci; Franco Granella; Vilija Jokubaitis; Mark Willis; Claire Rice; Neil Scolding; Alastair Wilkins; Owen R Pearson; Tjalf Ziemssen; Michael Hutchinson; Katharine Harding; Joanne Jones; Christopher McGuigan; Helmut Butzkueven; Tomas Kalincik; Neil Robertson Journal: JAMA Date: 2019-01-15 Impact factor: 56.272
Authors: Jan-Patrick Stellmann; Anneke Neuhaus; Lena Herich; Sven Schippling; Matthias Roeckel; Martin Daumer; Roland Martin; Christoph Heesen Journal: PLoS One Date: 2012-11-29 Impact factor: 3.240