All fields of study have their terms and jargon.  This is not unusual. However, the field of patient-focused policy may be may be unique in the sheer number of terms that appear to be similar, but all mean very specific things.  This has caused understandable confusion for industry and advocacy groups, but it is also causing confusion among regulators, policy makers, and patient experience researchers.  Given the muddled nature of these policy terms, I thought it might be a good idea to discuss a few of them in detail.

Let’s start with the acronym “PPI”.  I have encountered many iterations of what this acronym means including Patient Perspective Input, Patient Perspective Information, and Patient Preference Insights among others.  If you look to FDA, you will find that PPI stands for Patient Preference Information.  This is helpful, but what exactly is patient preference?  Patient preference is an assessment of patients’ desire for specific outcomes or attributes of a health intervention given a choice of interventions. Patient preference can be assessed as a patient-centered benefit risk, which is a quantitative assessment of patients’ tolerance for risks from a health intervention given its benefits compared to risk and benefits of alternative interventions.

Patient preference and patient-centered benefit risk are types of patient input.  As it turns out, patient input is an umbrella term for a range of insights that also includes patient experience and patient perspectives.  Patient perspectives are attitudes, perceptions, priorities, concerns, opinions, views, or preferences about their disease or its management.  While patient experience captures patients’ experiences, perspectives, preferences, needs, views, and priorities about living with their disease and its treatment.  Patient experience is an important component in patient-focused drug and medical device development.

If that wasn’t enough, there’s more!  Quite a bit of confusion exists about the difference between patient input and patient preference and patient reported outcomes (PROs).  PROs are measurements reported directly from a patient including symptoms, function, and quality of life unobservable by a clinician.  These are an individual measurement of personal function reported by the patient.  A lot of work has been done to develop validated PROs for use in clinical trials.  More recently, FDA is working on guidance for the development of clinical outcome assessments (COAs).  COAs include PROs and other performance-based measures used to assess clinical outcomes that may be reported by a clinician, patient, or observer.

There is a lot here, and we haven’t even covered all the terms being used in this policy space.  It’s no wonder there is confusion and lack of consistency.  There is a lot of work to be done to create a coherent framework in patient-focused policy.  Simplifying the terms we use would be a good place to start. 

Want some help sorting through all these terms?  I created a handy infographic that covers the ones described in this blog.  Send me an email at info@esc-strategic.com with your email address and I will send you a pdf.  The first 100 people to send me an email and a snail-mail address will receive a glossy infographic on cardstock to tack up in their office.