Only patients are able to inform on the quality of life impact of a disease. However, in some cases the insight of patients is compromised and information can only be derived from clinicians. Also the focus of the study may be on outcomes that are of primary interest to the clinician or which are difficult for the patient to report. In such cases health outcome assessments made by clinicians are crucial. Where no suitable scale exists it is possible to develop outcome measures specifically for this purpose.

The development of clinician-reported outcome measures follows a similar careful procedure as that used to develop patient-reported outcome measures. Development is based on the following procedure:

  1. Interviews and/or focus groups are conducted with clinicians to ascertain how the disease affects the outcome of interest in patients.
  2. Verbatim transcripts are produced and content analysis applied. A conceptual framework on the impact of the condition is then developed and a pool of potential items supporting the conceptual framework is produced.
  3. Subsequent applications of the measure to clinicians are used to establish that the measure has inter-rater reliability, reproducibility and validity and that it covers all the issues of relevance.
  4. Rasch analysis is applied to clinicians’ responses to ensure that the final measure is unidimensional allowing the application of parametric analyses of trial data.