Development of Patient Reported Outcome Measures (PROM)
The benefits, importance and relevance of Patient Reported Outcomes (PROs) have already been discussed in a previous article. We highlighted the benefits of PROs for precision medicine, for randomised controlled trials (RCTs) and for the marketing authorisation of medicines. > Read the full article here!
Today, we want to look at this topic from a different angle and answer the question of who actually creates the questionnaires that ask for subjective patient responses. How are PROMs checked for validity, i.e., the accuracy of the match between the measurement result and the measurement construct, and reliability, i.e., the error-free measurement so that the measurements also match the population? Are there any international standards for PROMs?
To answer these questions, we start at the beginning, with the manufacturers of PROMs. In the following, we will first introduce the two most important players in the industry.
What exactly is the ICHOM initiative?
In the book “Redefining Health Care”, 2006 the authors Michael E. Porter and Elisabeth O. Teisberg introduced the concept of value-based health care. This means that health care should be oriented in such a way that it creates “value” for patients. Value is defined as the outcome of health divided by the costs spent on it. The value calculation also includes, for instance, patient-reported outcomes. Ultimately, healthcare is to be focused on the value and the composition of the endpoint categories. Up to now, healthcare has only paid attention to the endpoint categories mortality, i.e., the number of deaths from a certain disease per 1,000 people per year, and morbidity, i.e., the number of people who fall ill in a population per year. Based on their own conviction that PROs in particular have a great additional benefit for healthcare, Porter and Teisberg, together with the Boston Consulting Group, founded the ICHOM in 2012 to collect these PROs.
ICHOM – that stands for International Consortium for Health Outcome Measurements, based in Boston, USA, develops the necessary tools to measure Patient Reported Outcomes together with patients, physicians and other industry experts. These are standardised questionnaires, so-called standard sets, which patients fill out themselves, depending on the target group and disease.[3,4] These standard sets are then used to measure subjective endpoints of therapies on the patients’ perceived quality of life. The result is then comparable in the same target group or among patients with the same disease.
What does ICHOM do?
What is the PROMIS initiative?
National divisions of PROMIS
The international PROMIS initiative is divided into national units. In Germany, for example, there is PROMIS Germany, based at the Charité Berlin. These national units translate the individual questionnaires so that they remain internationally comparable. In addition, PROMIS Germany takes care of the validation of the sets. This means that PROMIS Germany makes sure that the questionnaires really measure the construct they are supposed to measure.
Benefits and importance of the work of PROMIS and ICHOM
Self-reported patient outcomes collected by the two initiatives are enabling ever more individualised, precise therapy management, prognosis and screening. These measured outcomes have already become increasingly relevant in medical research and therapy evaluation in recent years. For example, the assessment of the benefit of the endpoint “quality of life” has been firmly anchored as a subjective endpoint in therapy evaluations for several years. Thus, we at XO Life also consider PROs to be a useful instrument to help medicine develop even more precisely, patient-oriented and value-oriented in the future.
 Terwee C.B., Zuidgeest M., Vonkeman H.E, Cella D., Haverman L., Noorda L.D. (n.d.). Common patient-reported outcomes across ICHOM Standard Sets – the potential contribution of PROMIS. https://osf.io/fbw2j/download
 Harvard Business School. (n.d.) International Consortium for Health Outcome Measurement. https://www.isc.hbs.edu/about-michael-porter/affiliated-organizations-institutions/Pages/ichom.aspx
 IQWiG. (2020) Konzepte zur Generierung versorgungsnaher Daten und deren Auswertung zum Zwecke der Nutzenbewertung von Arzneimitteln nach § 35a SGB V. https://www.iqwig.de/download/a19-43_versorgungsnahe-daten-zum-zwecke-der-nutzenbewertung_rapid-report_v1-1.pdf?rev=184598
 Deutsches Ärzteblatt. (2020). Rehabilitation: Messbarer Patientennutzen als Ziel. https://www.aerzteblatt.de/archiv/212785/Rehabilitation-Messbarer-Patientennutzen-als-Ziel
 ICHOM. (n.d.). About Us. https://www.ichom.org/mission/#founders
 Cella D. et al. (2007). The Patient-Reported Outcomes Measurement Information System (PROMIS). https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2829758/
 PROMIS. (n.d.). Hintergrund. https://promis-germany.de/ueber-promis-2/hintergrund/
 PROMIS. (n.d.). Publications by Year. https://www.healthmeasures.net/explore-measurement-systems/promis/measure-development-research/publications-promis