Rating (clinical trials) explained

Within the field of clinical trials, rating is the process by which a human evaluator subjectively judges the response of a patient to a medical treatment.[1] [2] The rating can include more than one treatment response. The assessor is normally an independent observer other than the patient, but the assessor can also be the patient (a patient-reported outcome). Furthermore, some clinical outcomes can only be assessed by the patient (a "private phenomenon").[3]

Because the evaluation is subjective, this can result in both inter-rater or intra-rater reliability.[4] When conducting clinical trials, ensuring rating consistency is important, but can prove to be quite difficult to obtain. Studies dealing with such indications as pain, mental disease or mood are not able to easily track progress with physical or physiological testing, rather, verbal subjective human testing is used. This can allow for an array of differences in rating.

Blinded assessors who are not told which treatment group a patient belongs to have a significantly lower observer bias compared to non-blinded assessors.[5] [6]

Rater training is sometimes used in an attempt to lower rater variability.[7] [8]

Notes and References

  1. Targum SD . Evaluating rater competency for CNS clinical trials . Journal of Clinical Psychopharmacology . 26 . 3 . 308–10 . June 2006 . 16702896 . 10.1097/01.jcp.0000219049.33008.b7 . 7047308 . primary .
  2. Khan A, Yavorsky WC, Liechti S, DiClemente G, Rothman B, Opler M, DeFries A, Jovic S . Assessing the sources of unreliability (rater, subject, time-point) in a failed clinical trial using items of the Positive and Negative Syndrome Scale (PANSS) . Journal of Clinical Psychopharmacology . 33 . 1 . 109–17 . February 2013 . 23277234 . 10.1097/JCP.0b013e3182776ebe . 27439252 . primary .
  3. Moustgaard H, Bello S, Miller FG, Hróbjartsson A . Subjective and objective outcomes in randomized clinical trials: definitions differed in methods publications and were often absent from trial reports . Journal of Clinical Epidemiology . 67 . 12 . 1327–34 . December 2014 . 25263546 . 10.1016/j.jclinepi.2014.06.020 . review .
  4. Book: Chin R, Lee BY . Chapter 4.5.3: Observer Variability . Principles and Practice of Clinical Trial Medicine . 25 July 2008 . 72–74 . Elsevier . 978-0-08-055793-9 . https://books.google.com/books?id=HgmrI2r5eo4C&q=4.5.3&pg=PA73 .
  5. Hróbjartsson A, Thomsen AS, Emanuelsson F, Tendal B, Hilden J, Boutron I, Ravaud P, Brorson S . Observer bias in randomized clinical trials with measurement scale outcomes: a systematic review of trials with both blinded and nonblinded assessors . Canadian Medical Association Journal . 185 . 4 . E201–11 . March 2013 . 23359047 . 3589328 . 10.1503/cmaj.120744 . review .
  6. Hróbjartsson A, Thomsen AS, Emanuelsson F, Tendal B, Rasmussen JV, Hilden J, Boutron I, Ravaud P, Brorson S . Observer bias in randomized clinical trials with time-to-event outcomes: systematic review of trials with both blinded and non-blinded outcome assessors . International Journal of Epidemiology . 43 . 3 . 937–48 . June 2014 . 24448109 . 10.1093/ije/dyt270 . review . free .
  7. Opler MG, Yavorsky C, Daniel DG . Positive and Negative Syndrome Scale (PANSS) Training: Challenges, Solutions, and Future Directions . Innovations in Clinical Neuroscience . 14 . 11–12 . 77–81 . December 2017 . 29410941 . 5788255 . review .
  8. Web site: Hall C, Dallabrida SM . Why Rater Training Matters in Clinical Trials: A Science Overview . https://web.archive.org/web/20160424071708/https://www.clinicalleader.com/doc/why-rater-training-matters-in-clinical-trials-a-science-overview-0001 . 24 April 2016 . dead . 16 March 2015 . Clinical Leader .

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