PROMs and PREMs: The Revolution in Patient-Centered Assessment in the Healthcare System

The healthcare system, historically focused on pathology and clinical outcomes measured by professionals, is undergoing a major transformation. Patient experience and perceived outcomes are becoming essential indicators for evaluating and improving the quality of care. At the heart of this evolution are Patient-Reported Outcome Measures (PROMs) and Patient-Reported Experience Measures (PREMs). These patient-reported measures offer a unique and indispensable perspective on the effectiveness of treatments and the quality of care. The development of PROMs and PREMs has been intense worldwide over the past decade, with a significant acceleration observed since 2015, reflecting a profound evolution in healthcare systems. The objective of this summary note is twofold: to determine the scope of legitimacy for pharmaceutical companies in using PROMs and PREMs, and to promote the value of their use throughout the drug lifecycle to encourage their widespread adoption. But beyond medication, PROMs and PREMs are revolutionizing evaluation across the entire healthcare system.

What Are PROMs and PREMs? Key Definitions and Distinctions

To understand this "revolution," it is essential to define these two distinct yet complementary concepts.

Patient-Reported Outcome Measures (PROMs) are measures of healthcare outcomes reported directly by patients. They assess patients' perceptions of their health status, symptoms, functional abilities, quality of life, and well-being. The evaluation is based on self-administered questionnaires or other data collection tools. PROMs can be generic, exploring issues important to the general population, or specific, focusing on a particular disease, intervention, or dimension (pain, fatigue, anxiety, depression). Generic PROMs commonly used in international studies include the EQ-5D (with its 3L and 5L versions), the SF-36 or SF-12 (short versions of the SF-36), and PROMIS (Patient-Reported Outcomes Measurement Information System). The World Health Organization (WHO) has also developed tools such as the WHO-5 (Well-being Index) and the WHO Disability Assessment Schedule 2.0 (WHO-DAS-12), which are generic PROMs. The ICHOM (International Consortium for Health Outcomes Measurement) recommends standardized sets of PROMs for various diseases or populations. Patient-Reported Experience Measures (PREMs), on the other hand, measure patients’ experiences with the healthcare system or the care they received. They cover the quality of the relationship with healthcare professionals, the organization of care, access to information, the facility environment, etc. The definition of PREMs is not always systematically reported or standardized internationally by assessment agencies, with the exception of some, such as the HAS in France. Initiatives such as the Consumer Quality Index (CQI) in the Netherlands or the CAHPS® (Consumer Assessment of Healthcare Providers and Systems) surveys in the United States are examples of standardized PREM questionnaires used on a large scale. In France, the e-Satis system is an example of mandatory national collection of PREMs.

The key distinction lies in what is measured: PROMs assess the outcome (changes in the patient’s health status), while PREMs assess the experience (how care was delivered and perceived). These two types of measures complement each other in providing a comprehensive view of the quality of care as perceived by patients.

Why are PROMs and PREMs important? Objectives and benefits

The growing interest in PROMs and PREMs is not accidental. They provide a unique and valuable perspective that was previously underrepresented in quality of care assessments. Their implementation is likely to generate numerous benefits and impact all stakeholders in the healthcare system. For patients and users, PROMs and PREMs offer a way to have their voices heard and contribute to improving their own care and that of others. Completing these questionnaires empowers patients to become active participants in their health and the evolution of the system. PROMs can facilitate communication with healthcare professionals during consultations by providing structured information about their symptoms and quality of life, which can improve follow-up and shared decision-making. Patient experience collection initiatives, such as PREMs surveys, strengthen the feeling of being heard and valued. For healthcare professionals and organizations, the use of PROMs and PREMs can improve daily clinical practice. The results can help to better monitor patient progress, quickly identify problems that might otherwise go undetected, and adapt treatments or support. At the organizational level, data aggregation allows for the evaluation of service performance, internal benchmarking to identify areas for improvement, and better resource allocation. For example, using PROM results can improve patients' quality of life by providing physicians with feedback on their functional status. For health authorities and regulators, PROMs and PREMs provide essential data for managing the healthcare system. They are used to assess the performance and quality of healthcare providers, to inform regulatory decisions (funding, authorization, reimbursement), and to enhance transparency. While not systematic everywhere, the public dissemination of results allows users to make informed choices among healthcare providers. The integration of PROMs and PREMs into pay-for-performance (P4P) models aims to incentivize healthcare providers to improve patient-reported outcomes and experiences. Furthermore, this data is invaluable for clinical research and evaluating treatment efficacy. In short, PROMs and PREMs constitute a new and complementary source of information, enabling a shift from purely clinical evaluation to a more comprehensive assessment that places the patient's perspective at the heart of the process. Integration of PROMs and PREMs into the Drug Lifecycle: The use of PROMs and PREMs is particularly relevant and variable throughout the drug lifecycle. Even before clinical trials begin, pharmaceutical companies can collect indicators from patients, often informally (interviews, focus groups), to better define their needs and priorities. Unstructured indicators or PREMs are primarily collected at this initial stage. Social media analytics initiatives, forum verbatim comments, and social listening can provide new and complementary information to industry for this purpose. During the research and development phase, particularly during clinical trials (phases II and especially III), PROMs are widely integrated. The majority of clinical trials conducted by pharmaceutical companies include PROMs, whether generic and/or drug-specific. This data collection (primarily PROMs) is a crucial phase, as it influences future assessments by health authorities. PROMs are used to evaluate the added value of the treatment or to examine whether the data collection can detect significant effects and influence the study's conclusions, particularly the benefit-risk assessment. However, obtaining Marketing Authorization (MA) is still largely unaffected by this data, as the evaluation is primarily based on clinical outcomes measured by healthcare professionals (CROMs). When applying for early access to a drug, the French National Authority for Health (HAS) recommends including a disease-specific self-administered questionnaire (PROM), whenever this measure is deemed relevant in practice. For reimbursement applications, the HAS stipulates that the absence of quality of life data (which can be measured by PROMs) can, in some cases, negatively impact the assessment of the Improvement in Medical Benefit (ASMR). However, the systematic integration and actual influence of this data on reimbursement decisions remain difficult to clearly assess. At the price negotiation stage by the Economic Committee for Health Products (CEPS), there is no formal recommendation regarding the integration of patient-reported outcomes (PROMs/PREMs). The negotiation process relies primarily on the assessment previously carried out by the health authorities. Finally, in the context of post-marketing surveillance studies, the HAS (French National Authority for Health) recommends the integration of a self-administered questionnaire (PROM) to collect data on quality of life or other measures relevant to patients. The absence of a PROM in the post-registration study protocol must be systematically justified. The integration of PROMs is therefore formalized and present throughout the drug lifecycle, at both the European and national levels. Conversely, PREMs are less formally integrated into the drug cycle itself, being more often measured at the healthcare system level and frequently collected informally by manufacturers prior to clinical trials.

The Use of PROMs and PREMs in the Healthcare System: An International Overview

A preliminary study compared the situation in France with that of four other countries, while a more in-depth report analyzed the use of PROMs and PREMs in 13 countries (7 European and 6 Anglo-Saxon). This overview highlights a wide variety of approaches and levels of implementation.

The levels of PROM and PREM collection vary considerably from one country to another. Initiatives are observed at the national, regional (or provincial), and local levels. Sweden is often cited as a leading country in the routine collection of PROMs and PREMs, particularly through its National Quality Registries (NQRs), which cover numerous conditions and procedures. The majority of the countries studied have structured national initiatives for PROMs (9 out of 13), sometimes supplemented by local initiatives. The situation is also varied for PREMs; some countries, such as Sweden, Norway, and the Netherlands, have long-standing or structured national systems, while others, such as the United States, use standardized systems like CAHPS® on a large scale. Germany and Denmark do not report any routine national or regional initiatives for PROMs, leaving data collection to local or research initiatives. The use of data from PROMs and PREMs falls into several main categories: Comparison and Benchmarking: This is a very common use for both PROMs (10 out of 13 countries) and PREMs. The goal is to compare outcomes between healthcare providers (facilities, professionals) to identify best practices and stimulate improvement. Countries such as England, the United States, and Sweden actively use this data for comparison. Benchmarking involves a continuous effort to learn from best practices. Accreditation (or Certification): The use of PROMs in healthcare facility accreditation processes is rare; none of the countries studied reported it. In contrast, PREM results are used in these systems in four countries, including France, where the national e-Satis system is integrated into the certification of healthcare facilities. Some Canadian provinces also use PREM survey results for accreditation. Public Dissemination of Results: Transparency is an important objective, but the public dissemination of PROM and PREM results is not systematic everywhere. It takes place in different formats: national reports by pathology (Sweden), rankings produced by insurers or associations (Netherlands), national websites (England with NHS Digital, United States with Hospital Compare). In France, e-Satis results are publicly disseminated via the Scope Santé website. Pay-for-Performance (P4P): The integration of PROMs and PREMs into healthcare provider funding models is a growing practice, although less common than for comparison purposes. Some countries link a portion of providers’ compensation to the results obtained on these indicators. Sweden uses PREMs to compensate primary care providers. The Netherlands uses them to inform funding agencies. The United States includes PROMs and PREMs in various P4P programs (e.g., the Hospital Value-Based Purchasing program, the ESRD QIP for dialysis). Belgium integrated PREMs into its P4P program in 2018. In France, e-Satis results are integrated into the Financial Incentive for Quality Improvement (IFAQ) scheme.

The international landscape shows that the use of PROMs is more focused on comparison and research, while PREMs are more often incorporated into regulatory mechanisms, such as certification or pay-for-performance.

The Status of PROMs and PREMs in France

France is part of this national and international movement to take the patient’s perspective into account. The French National Authority for Health (HAS) plays a key role in this area. A preliminary study examined the perspectives of health authorities, patients, and pharmaceutical companies in France.

When it comes to PREMs, France is among the most advanced countries in terms of collecting and using their results.

The national e-Satis system is a mandatory system for collecting patient experience and satisfaction feedback following certain hospitalizations (short-stay acute care, outpatient surgery, and rehabilitation). Data collected via e-Satis is used for comparisons between healthcare facilities, incorporated into the healthcare facility certification process, publicly disseminated via the Scope Santé website to inform the public, and taken into account in the quality-based funding mechanism (IFAQ). Regarding PROMs, France is currently less advanced than with PREMs in terms of a national system for routine data collection. However, many initiatives are currently under development or being tested. Public and nonprofit research platforms facilitate the collection of PROMs, such as the AP-HP’s ComPaRe platform, where patients with chronic illnesses complete online questionnaires, or the Renaloo association’s Moi Patient platform for patients with chronic kidney disease. Within the framework of national pilot programs for innovative organizations, as stipulated in Article 51 of the 2018 Social Security Financing Law (LFSS 2018), the use of PROMs is being considered or implemented. This is the case for the lump-sum payment for chronic kidney disease care (with the potential integration of PROMIS-29), or for the pilot program for episode-based payment for certain surgical procedures (hip, knee, colectomy for cancer) where professionals can use existing PROMs. The pilot program for incentives for shared care (IPEP) and the project for lump-sum payments to teams of healthcare professionals in the community (PEPS) also use patient questionnaires, including PREMs. Regional initiatives also exist, such as the collection of PROMs from HIV-positive patients tested in Aquitaine as part of an ANRS study. French healthcare facilities participate in international initiatives, notably the ICHOM project, contributing to benchmarking for various conditions (cancers, cataracts). France also participates in the OECD overview on the collection of PROMs for specific conditions such as hip replacement or breast cancer. The HAS (French National Authority for Health) plays an active role in supporting these developments. It plans to continue and expand its work on measuring patient-perceived quality. It offers practical guides to assist with the local implementation of PROMs. Three initial guides have been published: one general guide on concepts and criteria, and two others focusing on specific contexts (hip/knee replacement/colorectal cancer and COPD patient pathways). In its scoping note, the HAS (French National Authority for Health) also considered, following the report, initiating a self-referral to include the development and implementation of PROMs (Program for the Improvement of Patient Experience) and PREMs (Prevention of Patient Experience) measures in a multi-year program. Despite significant initiatives, France still lacks a structured national or regional system for the routine collection of PROMs, unlike PREMs. PROMs data are often collected within the framework of specific research projects or experiments.

Challenges and Opportunities for the Implementation of PROMs and PREMs

The large-scale deployment and optimal use of PROMs and PREMs face several challenges, which have been identified both in France and internationally.

A major obstacle lies in the lack of standardization. There is significant variation in the instruments (questionnaires) used to measure PROMs and PREMs, the data collection methods, and the ways in which results are presented. This lack of standardization makes it difficult to compare different initiatives or healthcare providers. Even within the same medical condition, several PROMs may be used, preventing direct comparison of results between patients or institutions. The lack of consensus on PREMs is particularly noteworthy, with a definition that is not always clear at the international level. Methodological and operational difficulties are also encountered. Designing relevant questionnaires adapted to different populations (age, health status, language proficiency) is complex. Response rates to questionnaires, particularly online or in routine clinical practice, can be relatively low. The length of some questionnaires can be an obstacle. Successful implementation of data collection requires careful planning beforehand. It is important to clearly define the objectives of data collection, the target populations, and the collection timeframes. Technical and organizational barriers exist. Integrating PROM and PREM data into existing information systems (electronic health records, registries) can be complex. Healthcare professionals may lack the training and dedicated time to use these indicators during consultations and to discuss the results with patients. The lack of human and financial resources to support data collection and analysis is a hindrance. Another significant challenge, particularly in the context of pharmaceuticals, is the lack of consideration given to patient indicators by health authorities in certain decisions. Analysis of concrete examples has shown limited flexibility on the part of authorities in using this data, for example, beyond the standard clinical criteria for marketing authorization. Similarly, patient indicators are not formally required for drug price negotiations in France. In the broader healthcare system, PROM results are not used for facility accreditation in the countries studied.

In light of these challenges, several measures can be taken:

• Standardization is crucial, as it promotes the use of validated and standardized tools, particularly through international initiatives (ICHOM, OECD Paris) that develop sets of indicators. Harmonization at the national or regional level (such as the initiative in Wales) can facilitate comparison and implementation. Support for healthcare professionals is essential, through training, practical guides (such as those from the HAS), and the integration of PROMs into the clinical workflow with dedicated time for discussing results. Adapting data collection methods (paper, online, tablet, mobile app) to make them simple and flexible for patients, while taking into account the specific needs of the target populations, is also crucial. Using technologies like Computer Adaptive Testing (CAT) for PROMIS can reduce the burden on the patient.
• Patient involvement in the co-creation of measurement tools and data collection processes enhances their acceptability and relevance.
• Strategic integration of PROMs and PREMs into health policies: incorporating them into evaluation (reimbursement, access), certification, and pay-for-performance mechanisms. Public sector commitment is a key driver.
• Transparent dissemination of results, achieved by standardizing report formats and making them accessible to the public and professionals.

These measures require a strong commitment from all stakeholders in the healthcare system.

What Does the Future Hold for PROMs and PREMs? Perspectives and Development

The momentum behind the development of PROMs and PREMs is strong and should not be questioned. The future of these patient-reported measures looks promising, with several avenues for development.

A key trend is the increased integration into routine clinical practice. The goal is for the collection of PROMs and PREMs to no longer be limited to research projects or experiments, but to become an integral part of patient follow-up, consultations, and ongoing quality assessment. Expanding data collection to a wider range of conditions and care settings (primary care, chronic diseases, mental health, home care) is also being considered.

Standardization will remain a major challenge in enabling reliable comparisons and large-scale data aggregation. International efforts (ICHOM, PaRIS) to define standardized sets of PROMs and PREMs by condition or care pathway will continue to play a vital role. Technological advances will offer new opportunities for the collection and use of patient data. Mobile applications, connected devices, and online platforms facilitate real-time data collection and integration into electronic health records. The analysis of unstructured data from social media or patient verbatim ("social listening") could also be further structured to extract useful insights into the experience and perceived outcomes. The strategic use of data by health authorities and payers is also expected to increase. Although challenges remain, it is likely that PROM and PREM results will play an increasingly important role in the evaluation of health technologies (medicines, medical devices), reimbursement decisions, price negotiations, and facility funding. The emphasis on Value-Based Healthcare, which incorporates outcomes that are important to patients, reinforces the relevance of PROMs. In France, the HAS (French National Authority for Health) has clearly stated its intention to continue and expand its work in this area, with the prospect of a multi-year program dedicated to developing the implementation of PREMs and PROMs. The development of practical guides and support for local pilot projects are concrete steps to facilitate adoption. The role of patients and their associations will continue to grow. Their involvement in the design, deployment, and use of PROMs and PREMs is recognized as a key success factor. In conclusion, the future of PROMs and PREMs lies in their deeper and more systematic integration into quality of care assessment and decision-making at all levels of the healthcare system. This evolution is essential to truly place the patient’s perspective at the heart of the quality improvement process and to guide healthcare systems based on what really matters to those receiving care. Despite the challenges, current trends suggest that PROMs and PREMs are destined to become indispensable tools for a more patient-centered, transparent, and efficient healthcare system.