Learn about Patient Reported Outcome Measures (PROMs).
Patient Reported Outcomes: A Primer on the Conceptual Frameworks
Clinicians often refer to patient reported outcomes (PROs) as patient surveys, quality of life measures, questionnaires, or waiting room activities. But the formal definition comes from the Food and Drug Administration (FDA) in the United States, which defines PROs as:
“…any report of the status of a patient’s health condition that comes directly from the patient, without interpretation of the patient’s response by a clinician or anyone else.”1
The reason we use the definition from the FDA stems from the history of PROs. PROs got its footing in clinical trials conducted in the mid-1990s, when health economists were trying to quantify subjective reports changes in study participants’ health conditions2. While PROs are still used in clinical trials, they have grown to be used in real-world clinical practice, including as means to track symptom history, monitor the effects of an intervention, and as an outcome measures for quality improvement or performance evaluation3.
The FDA definition is itself subject to some interpretation depending on the conceptual, operational, and administration models of interest. This post will focus on the various conceptual models that can be applied to defining and measuring PROs.
New in PROs
New articles continue to add perspectives and ideas about patient-reported outcomes (PROs). Here is some recent literature for those looking to better understand PROs and their effects on the healthcare system and clinical care.
Summary of the 22nd Annual ISOQOL Conference
The 22nd annual conference for the International Society of Quality of Life Research (ISOQOL) was recently held in our backyard – right here in Vancouver. The theme of this year’s conference was “The Matrix: Quality of Life in Social Context”. Indeed, many of the presentations looked at quality-of-life using a variety of different lenses than the conventional patient-reported symptom severity and functional status one. Social well-being was one lens with which “quality-of-life” was measured. So too was a concept of personalizing the meaning of quality-of-life to the individual patient.
Guest Post: Selecting a PRO instrument for use at the point-of-care: the experience of the Alberta Ocular Brachytherapy Program
Patient-reported outcomes (PROs) were originally developed for clinical trials, where they were incorporated into regular data collection along with biospecimen sampling, testing, or other measures. As a result, PRO instruments could afford to be lengthy – many questions could be asked to capture the fine nuances of symptom severity and functional status.
PROs have since grown into an important tool used by many clinicians as part of routine clinical practice [1]. But using the same PRO instruments developed for clinical trials at the point-of-care has several problems. First, the length of these instruments can place a burden on patients prior to their clinical encounter. Second, the scoring of these instruments can be onerous for the physician, especially when trying to do so between patients. Collectively, this can disrupt the clinical flow, causing delays and frustrations.
This was the situation faced by the Alberta Ocular Brachytherapy Program in Edmonton, Alberta. This program specializes in the treatment of uveal melanoma, the most common form of eye cancer [2].
Guest Post: Patients with chronic OAB – how much do they know about their condition?
From a healthcare systems perspective, chronic conditions represent some of the most challenging healthcare needs to address. Studies in both the United States and Canada consistently demonstrate that these conditions are amongst those with the widest variations in their utilization of resources – driven not by clinical guidelines, but the availability of services in the local area [1, 2]. When poorly managed, chronic conditions can also result in expensive acute incidents, requiring hospitalization and potentially more complicated care [3].
To help manage these conditions and defray the costs associated with their care, patient self-management is often advocated [4]. Under this, patients are expected to help manage their condition by avoiding behaviors that exacerbate symptoms and perform minor interventions themselves. Underlying the self-management principal is that patients have a good understanding of their condition, its management, and treatments.
Overactive bladder (OAB) is an example of a chronic condition that is expensive to manage through the healthcare system, and proper patient self-management can minimize those costs. A recent survey of Canadians approximated that 2.1 million individuals had the condition, costing provincial healthcare systems $380 million per year to care for [5].
As a first step to designing a formal self-management program, a multidisciplinary outpatient urology clinic based in Calgary, Alberta set out to study how much patients diagnosed with OAB knew about their condition. It was hypothesized that patients with more severe OAB symptoms would be more knowledgeable about the condition and its associated treatments compared to those with less severe OAB, either because of education from their primary care physician or through self-education.
Guest Post: Using mHealth to collect patient reported outcomes from youths with physical disabilities
Youths with physical disabilities often experience pain (Ehde et al., 2009). This pain can cause considerable disruption in their daily activities such as sleep, appetite, family functions, and peer relationships (Oddson et al., 2006). Clinically managing this pain requires regular surveillance, often based on patient self-reports.
Patient-reported outcomes (PROs) are frequently used to self-report factors associated with health, such as pain. PROs are validated instruments used to assess symptom severity and functional impairment (McDowell, 2006). They are conventionally administered through paper-and-pencil methods, either through postal surveys or at the point-of-care (Fayers et al, 2007). However, this mode of administration has multiple limitations (Kalnins et al., 1999).
Performance Anxiety and PROMs
On February 25th, members from the VALHUE study team attended the 26th annual CHSPR health policy conference titled “Performance Anxiety”, in Vancouver, BC. This year’s conference was focused on performance measurement in the Canadian healthcare system, and included Canadian as well as international perspectives from UK and Australia. The conference featured discussions about the current state of affairs of performance measurement in Canada; what is being done, how, and the impact of performance measurement on healthcare system change. Included in that was the role patients play in engaging in research through the use of patient reported outcome measures (PROMs) and patient reported experience measures (PREMs).