Ann Rheum Dis 66:iii40-iii41 doi:10.1136/ard.2007.079798
  • Looking at clinical trials and more

Minimal clinically important improvement/difference (MCII/MCID) and patient acceptable symptom state (PASS): what do these concepts mean?

  1. Tore K Kvien1,
  2. Turid Heiberg2,
  3. Kåre B Hagen3
  1. 1
    Department of Rheumatology, Diakonhjemmet Hospital, Oslo, Norway
  2. 2
    Department of Research and Education, Ullevål University Hospital, Oslo, Norway
  3. 3
    National Resource Centre for Rehabilitation in Rheumatology, Departmentt of Rheumatology, Diakonhjemmet Hospital, Oslo, Norway
  1. Tore K Kvien, Department of Rheumatology, Diakonhjemmet Hospital, Box 23 Vinderen, N-0319 Oslo, Norway; t.k.kvien{at}
  • Accepted 25 July 2007


An increasing focus has over recent years been directed to the use of categorical endpoints to define response, i.e. to define cut-points for important improvement and/or acceptable clinical state. The levels of Minimal Clinically Important Improvement (MCII) are typically defined according to the patients perception of what is an important improvement. It can be defined as the smallest change in measurement that signifies an important improvement. MCII signifies an improvement of relevance in a clinical trial, or the minimal meaningful change at an individual level. The Minimal Clinically Important Difference (MCID) may reflect either an improvement or a worsening. Patient Acceptable Symptom State (PASS) has been defined as the highest level of symptom beyond which patients consider themselves well. Cut-points for MCII and PASS are usually identified through two different statistical approaches. The 75th percentage approach identifies the cut-point corresponding to the 75 percentile of the scores for improvement in patients who report an important improvement by the anchoring question. Applying receiver operating characteristic (ROC) curves allows for choosing the threshold that is the best compromise between sensitivity and specificity for each outcome criterion.

The identified cut-points for MCII and PASS may easily be incorporated as endpoints in clinical trials, and will provide information about the proportion of patients that achieve an improvement exceeding the level accepted as MCII and achieve a state accepted as PASS.


  • Competing interests: None declared.

  • Abbreviations:
    ankylosing spondylitis
    health-related quality of life
    Minimal Clinically Important Difference
    Minimal Clinically Important Improvement
    Patient Acceptable Symptom State
    rheumatoid arthritis
    receiver operating characteristic
    visual analogue scales