PRO, PROMs, PREMs and PPI

Patient-Reported Measures (PROMs)

PROMs are questionnaires used to measure a patient's health status and health-related quality of life. They can be either general or disease-specific and include aspects such as functional status, health behaviors, and personal experience of care.

• Broad-based PROMs, like the EuroQol EQ-5D, enable comparisons across medical conditions and cost-effectiveness analysis.
• Disease-specific PROMs are designed for specific symptoms and conditions and have greater face validity but limit comparisons. Clinical studies often use a combination of both generic and disease-specific PROMs.

PROMs in research

PROMs were initially developed for use in research and were mainly used in England, Sweden, and parts of the US. By 2000, they were introduced in the US as a reimbursement mechanism for accountability. The use of PROMs has expanded beyond research to transform healthcare and improve quality and safety by placing patients at the center of decision-making. Regulatory bodies like the FDA and EMA have released guidelines mandating the use of PROMs in clinical trials. In the UK, it's mandatory to use PROMs to report outcomes for certain elective surgical patients, and the government aims to compare health services and drive quality improvement. The Patient-Reported Outcomes group at Oxford University has produced evidence-based reports on PROMs for chronic conditions and the use of PROMs has led to the need for guidance on the development and measurement of PROs.

Overcoming issues in the development and selection of PROMs

PROMsplay an important role in clinical trials and quality improvement initiatives. There are several methodological challenges in the development and selection of appropriate PROMs, such as validity, sensitivity, reliability, generalizability, and feasibility. One issue is the selection of valid and sensitive PROM instruments. Validity is based on whether the instrument accurately represents what it is intended to measure, and content validity is established through analysis of the instrument's content and the concept being measured. Another issue is the comparison between PROMs, as there may be different definitions of a particular outcome and multiple instruments to choose from. A conceptual model and framework can guide the selection and analysis of PROs. National guidelines and organizations such as PROMIS assist in standardizing the development and use of PROMs. Another challenge is the reliability and size of PROMs, and work is being done to make shorter, more reliable instruments using item response theory (IRT) and computerized adaptive testing tools. The goal of developing shorter and more reliable PROMs is to increase patient participation, particularly among underrepresented patient populations.

Patient-Reported Experience Measures (PREMs)

“Patient-reported experience measures (PREMs) are tools and instruments that report patient satisfaction scores with a health service and are generic tools that are often used to capture the overall patient experience of health care. (1)”

Patient-Reported Experience Measures (PREMs) are commonly used to evaluate patient satisfaction with healthcare services, both in the general population and in specific settings such as outpatient departments. These measures have been shown to have positive associations with patient satisfaction and safety, and are a reliable way of gauging the quality of care from a patient's perspective. Internationally, PREMs are also used to assess the clinical effectiveness and economic efficiency of healthcare.

However, limitations and challenges need to be taken into consideration when developing policies based on patient experience and PREMs. In the US, there is a trend of using patient satisfaction scores as metrics for reimbursement by the Centers for Medicare and Medicaid Services and private insurers. However, Lyu et al (2) argue that relying solely on these scores without considering context may not always be reliable, especially in surgical settings where patient satisfaction may not reflect the quality of surgical processes. In these cases, patient satisfaction may be more related to aspects of care that are familiar and visible to the patient, such as administrative processes, ward cleanliness, and discharge practices.

In the UK, there is a focus on measuring patient experience through both indicators and metrics. Metrics are precise measures of a specific attribute, such as the number of falls on a ward. Indicators, on the other hand, are metrics that identify issues requiring further investigation, such as an increase in the number of falls. Patient experience indicators are becoming increasingly important in NHS accountability frameworks, and are being used at various policy and management levels as the importance of patient experience as a marker of care quality becomes more widely accepted. The NHS National Quality Board has produced a definition of patient experience with eight indicators to guide measurement, including respect for patient values, communication and education, emotional support, and access to care.

Patient and Public Involvement (PPI)

PPI involves patients and the public actively participating in the entire research process, from inception to analysis and dissemination, in contrast to PROs and PROMs which involve research "about" or "to" patients. The involvement of consumers in the research process is thought to lead to higher quality and clinically relevant research. PPI has been supported by policies and initiatives, such as the 1999 Department of Health policy directive and INVOLVE, which promote and evaluate PPI in NHS research. Funding bodies, such as the NIHR, now require evidence of PPI in research applications for funding.

References

1. Weldring T, Smith SM. Patient-Reported Outcomes (PROs) and Patient-Reported Outcome Measures (PROMs) Health Serv Insights. 2013 Aug 4;6:61-8. doi: 10.4137/HSI.S11093. PMID: 25114561; PMCID: PMC4089835.
2. Lyu H, Wick EC, Housman M, Freischlag JA, Makary MA. Patient satisfaction as a possible indicator of quality surgical care. JAMA Surg. 2013;148(4):362–367.