Patient Reported Outcome Indices for Multiple Sclerosis
The Patient Reported Outcome Indices for Multiple Sclerosis (PRIMUS) is a disease specific patient-reported outcome questionnaire which measures the quality of life (QoL) of patients with multiple sclerosis.{{cite journal|last=Doward|first=LC|author2=McKenna, S.P. |author3=Meads, D.M. |author4=Twiss, J |author5= Eckert, BJ |title=The development of patient-reported outcome indices for multiple sclerosis (PRIMUS)|journal=Multiple Sclerosis Journal|year=2009|volume=15|issue=9|pages=1092–1102|doi=10.1177/1352458509106513|pmid=19556315|s2cid=7459469 }}
The measure contains an assessment of quality of life, activity limitations and symptoms. A higher score on any or all of these scales indicates a lower quality of life due to the disease.{{cite journal|last=Twiss|first=James|author2=Doward, Lynda C. |author3=McKenna, Stephen P. |author4= Eckert, Benjamin |title=Interpreting scores on multiple sclerosis-specific patient reported outcome measures (the PRIMUS and U-FIS)|journal=Health and Quality of Life Outcomes|date=2010|volume=8|issue=117|pages=117|doi=10.1186/1477-7525-8-117|pmid=20937112|pmc=2964544 |doi-access=free }}
History and properties
First published in 2009 by Galen Research and funded by Novartis Pharmaceuticals, the PRIMUS was developed in order to provide a more holistic view of the impact of MS on a patient.
The measure has three scales: quality of life, symptoms and activity limitations, which are designed to be used together or as standalone measures. The QoL and symptom scales are based on simple statements with dichotomous response options. Each scale has a total score which ranges from 0 to 22. The activity scale is based on 15 statements describing tasks. Patients are asked to rate their ability to perform these tasks on a scale from 1 to 3. The total score of the activities section ranges from 0 to 30.{{cite journal|last=McKenna|first=Stephen P. |author2=Doward, Lynda C. |author3=Twiss, James |author4=Hagell, Peter |author5=Oprandi, Nadia C. |author6=Fisk, John |author7=Grand'Maison, Francois |author8=Bhan, Virender |author9=Arbizu, Txomin |author10=Brassat, David |author11=Kohlmann, Thomas |author12=Meads, David M. |author13=Eckert, Benjamin J. |title=International Development of the Patient-Reported Outcome Indices for Multiple Sclerosis (PRIMUS)|journal=Value in Health|date=December 2010|volume=13|issue=8|pages=946–951|doi=10.1111/j.1524-4733.2010.00767.x|pmid=20667058 |doi-access=free }}
International use
Since the development of the PRIMUS, it has been translated into several languages including Canadian English and French, French, German, Italian, Spanish, Swedish, US English, Australian and New Zealand English and US Spanish.{{cite web|title=Measures Database|url=http://www.galen-research.com/measures-database/|work=Galen-Research.com|publisher=Galen Research|access-date=8 October 2013}} This has allowed researchers to conduct studies for specific populations, such as Spain{{cite journal|last=Hernandez|first=M.A.|author2=Mora, S.|title=Use of the PRIMUS scale to assess quality of life in a Spanish population of multiple sclerosis patients.|journal=Neurologia|year=2013|volume=28|issue=6|pages=340–347|doi=10.1016/j.nrleng.2012.06.003|pmid=23067780 |url=http://zl.elsevier.es/en/revista/neurologia-495/articulo/use-of-the-primus-scale-90217987|access-date=8 October 2013|url-access=subscription}} and Europe.{{cite journal|last=Karampampa|first=Korinna|author2=Gustavsson, Anders |author3=Miltenburger, Carolin |author4= Eckert, Benjamin |title=Treatment experience, burden and unmet needs (TRIBUNE) in MS study: results from five European countries|journal=Multiple Sclerosis|year=2012|volume=18|issue=2|pages=7–15|doi=10.1177/1352458512441566|pmid=22623122|s2cid=36736082 }}
Clinical studies
The PRIMUS has been utilized in clinical trials which assess the efficacy of a treatment or medication. If a patient's score on the PRIMUS changes after a trial has taken place, it is inferred that the trial has had an effect on the patient's quality of life. PRIMUS has been used to assess the efficacy of fingolimod{{cite journal|last=Ziemssen|first=T.|author2=Meergans, M. |author3=Vollmar, P. |author4=Kempcke, R |author5=Tracik, F. |author6= van Lokven, T. |title=Study design and first interim results of a registry study to establish long-term safety and pharmaco-economic data on fingolimod (Gilenya®) in multiple sclerosis patients in Germany (PANGAEA)|journal=Multiple Sclerosis|date=October 2012|volume=18|issue=4|page=222|doi=10.1177/1352458512459019|s2cid=208625075 }}{{cite conference
|first = van Lokven
|last = T.
|author2 = Kempcke, R.
|author3 = Ziemssen, T.
|author4 = Meergans, M.
|title = Study design of a non-interventional registry study to establish long-term safety and pharmaco-economic data on fingolimod (Gilenya®) in multiple sclerosis patients (PANGAEA)
|book-title = 5th Joint triennial congress of the European and Americas Committees for Treatment and Research in Multiple Sclerosis
|date = 2011-10-20
|location = Amsterdam, the Netherlands
|url = http://registration.akm.ch/einsicht.php?XNABSTRACT_ID=137571&XNSPRACHE_ID=2&XNKONGRESS_ID=150&XNMASKEN_ID=900
|access-date = September 10, 2013
|url-status = dead
|archive-url = https://archive.today/20131108154143/http://registration.akm.ch/einsicht.php?XNABSTRACT_ID=137571&XNSPRACHE_ID=2&XNKONGRESS_ID=150&XNMASKEN_ID=900
|archive-date = 2013-11-08
}}{{cite journal|last=Cascione|first=Mark|author2=Wynn, Daniel |author3=Agashivala, Neetu |author4=McCague, Kevin |author5=Pestreich, Linda |author6=Schofield, Lesley |author7=Kim, Edward |author8= Barbato, Luigi |title=Patient-Reported Treatment Satisfaction, Reasons for Therapy Change, and Health-Related Quality of Life at Baseline from the Trial To Evaluate Patient OutComes, Safety and Tolerability of Fingolimod|journal=Neurology|date=2013|volume=80|issue=1|doi=10.1212/WNL.80.7_supplement.P03.222 |url=http://www.neurology.org/cgi/content/meeting_abstract/80/1_MeetingAbstracts/P03.222|access-date=9 October 2013|url-access=subscription}} and rivastigmine.{{cite journal|last=Maurer|first=M|author2=Ortler, S |author3=Baier, M |author4=Meergans, M |author5=Scherer, P |author6=Hofmann, WE |author7= Tracik, F. |title=Randomised multicentre trial on safety and efficacy of rivastigmine in cognitively impaired multiple sclerosis patients|journal=Multiple Sclerosis|date=2012-10-15|volume=19|issue=5|pages=631–638|doi=10.1177/1352458512463481|pmid=23069874|s2cid=6838286}}