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Patient Centred Outcomes: the REAL measure of success for pharma

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Date: 26/5/2017

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Angela Rylands, Patient Centred Outcomes Consultant, pH Associates.

"Healthcare exists to improve and extend people's lives", described the authors of a recent 'Pharmafocus' article (May 2017). "When it comes down to it..", the authors assert, "..the ultimate measure of success of any treatment is the actual impact it has on the patient". Presumably, treatment should make life easier for the individual with a health condition, by allowing the individual to go about their daily living, with minimal obstruction from their health related issues. The ability to measure the actual impact of a treatment on the patient, means being able to evaluate health-care outcomes in 'real', human terms.  But how can we do this accurately?

Fortunately, there are a number of robust and reliable ways of measuring the 'real' impact of treatment on patients, commonly referred to patient centred outcomes (PCOs), or patient reported outcomes (PROs). PCO measures are carefully designed questionnaires, or instruments that allow patients to describe aspects of their health, healthcare or treatment in a way that is meaningful to them. In other words, PCO measures can tell us about how a treatment is impacting an individual's life. For example, a PCO may tell us how well a patient is getting on with their day-to-day tasks, their ability to dress or wash, or go to work, or to spend time with friends and family. Whatever it is that patients with a particular condition have identified as important, these are the things (or 'concepts') that patients are often concerned about their condition or treatment disrupting.  Perhaps patients' 'real' aspirations about treatments are that they enable the individual to get on with usual daily lives as normally as possible. Your next question may be; how do we know what the patients want, unless we ask them?

Well-designed PCO measures have done just that; in the development phases of valid and acceptable PCO instruments (according to the European Medical Agency [EMA] and Food and Drug Administration [FDA] guidelines), a group of patients with a particular condition will have been interviewed extensively to determine the most pertinent aspects of their daily living that are affected by their condition.  A robust PCO instrument will have been meticulously designed to include the 'items' or 'concepts' outlined by the patients during carefully structured interviews or focus groups. After several iterations of refinement and psychometric validation with clinicians and patients, the PCO measure/instrument should then be fit for purpose.  Subsequent tests of the PCO instrument's reliability (or repeatability) will be necessary to substantiate it's robustness, and eventually, a PCO measure that stands to measure the 'real' impact of a treatment on a patient, is derived. 

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Pharma is certainly not missing out on the opportunity to measure the patient experience using PCOs. Not least because PCO data is now viewed as important enough to support the drug application process (often by backing up the assertions of product efficacy made by the manufacturer).  In fact, PCOs are changing the face of treatment delivery, and pharma are beginning to include PCO measurement much earlier in the drug development process, thereby enabling pharma to actually put the patient experience at the heart of treatment delivery. Not only are pharma increasingly viewing PCOs as critical to understand the effectiveness of medicines, but PCO data really does allows pharma to stand proudly beside their patient-centric logos.  The data can and does enhance personalised care for patients, helping to determine how patient subgroups react to various treatment options in the short, medium and long-term and the data can also facilitate the patient-clinician dialogue, providing critical insights to clinicians and healthcare providers about how patients are responding to treatments.

Amidst the rapidly growing technology and easy availability of patient-sourced data (via increasing numbers of online patient support communities, forums and blogs) there are ample sources of PCO data to be gathered.  Of course, methods to use this data should be considered cautiously and the PCO field is making tremendous efforts to introduce rigour to the quickly evolving technologies (e.g. ISPOR guidelines). There is a new wave of patients out there that are more and more willing to share PCO related data and with the rise of personalised health data with Apple's Health app and wearable health trackers, we are entering an era of exciting possibilities for PCO data collection. 

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Pharma must seize this opportunity to embed robust PCO measurement into the next generation of healthcare solutions and maintain the mantra of keeping patients at the heart of their drug development by helping PCO take a leading role in measuring the success of pharmaceutical products. 

 

If you would like to hear more about how you can collect data from patients please contact us: angelarylands@phassociates.com and catherinebottomley@phassociates.com

 

 

 

 

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