Introduction

The benefits of a patient-centered ecosystem to strengthen the process of healthcare decision-making and clinical care continue to be identified and come into sharper focus. At the core of this discussion is the use of patient-reported outcomes (PRO), data on health conditions that come directly from patients without input from others (e.g., a healthcare provider) [1, 2].

Advocates for the added value of the patient voice in healthcare decision-making point to the synergistic effect of the use of PRO measures (PROM) in routine clinical care in combination with more traditional diagnostic assessments [3] and clinical care decisions [4]. This sentiment was echoed by the Centers for Medicare & Medicaid Services (CMS) in the United States (US) in 2015, which adopted a system rewarding value rather than volume when reimbursing healthcare providers for services provided [5]; in the decade that has followed, other stakeholders (e.g., reimbursement/regulatory agencies, health policy-makers) have begun to explore ways to transform this concept into an actionable plan.

PRO data are typically collected through PROMs, or questionnaires that are specifically developed for this purpose. Generally, there is consensus that PROMs can provide valuable insight for clinical care. The use of PROMs at the individual patient level enables patients to actively participate in their care and for healthcare providers to gain a better understanding of patients’ symptoms, functioning, and health-related quality of life [3]. At the population level, the systematic capture of PRO data over time facilitates the ability to assess gaps (in healthcare performance and/or delivery) and shape policy decisions in healthcare delivery [3].

The development of digital health technologies has reached peak pace, and the ability to capture a vast range of PRO data digitally is revolutionizing the traditional healthcare model [6]. Digital technologies encompass a wide array of information technology (e.g., remote sensors and wearables, telehealth, data analytics) aiming to improve healthcare delivery [7]. They offer real-time, personalized care with the potential to improve how healthcare providers diagnose and treat disease and how patients monitor their care [6]. The World Health Organization (WHO) has developed a Global Strategy on Digital Health, with an aim of making health systems “more efficient and sustainable, enabling them to deliver good quality, affordable and equitable care [8].” To this end, WHO has outlined the need for translating data into action [8]. In addition, the European Commission has prioritized digital health through shared data resources (e.g., data, expertise, computing processing, and storage capacities) and greater patient access to health data and digital tools [9].

Although these benefits are increasingly being recognized by healthcare systems, challenges (e.g., logistics, bureaucracy, costs, data security) remain for their integration in existing healthcare structures (6), as do concerns of possible harms associated with digital technologies [10]. Organizations such as the Agency for Healthcare Research and Quality (AHRQ) in the US have endeavored to harmonize implementation efforts through the development of the Outcomes Measures Framework [11]. This minimum set of standardized outcome measures across five clinical indications is a concrete step in building a data infrastructure that can support the use of PROMs in both research and clinical settings [11].

Several reviews have examined the benefits and challenges associated with adoption of PROMs into routine clinical care; however, the majority of these address a specific condition or treatment area [12,13,14,15], with few studies available that provide an agnostic overview. Against this background, the aim of the current study was to conduct a scoping review to identify current benefits of and roadblocks to the use of PRO data in the patient-clinician interaction from both perspectives, plus to examine the challenges at the healthcare system level for incorporating PROMs into the clinical workflow. A critical examination of the findings was performed to evaluate the current thinking and propose a set of policy enablers so other organizations can harness the potential of PROMs.

Methods

Search strategy

A scoping review was conducted according to guidance from the Preferred Reporting Items for Systematic Reviews and Meta-Analyses statement (PRISMA) [16]. The Embase and MEDLINE databases were searched on November 25, 2024, for articles published from 2014 to the present. The search strategy (see Supplementary Table 1) was developed to capture all articles that discuss the role of PRO data in patient quality of life, clinical care, and value assessment decision-making. No other restrictions were applied.

A manual search was performed of websites of national health technology assessment agencies in countries with established healthcare decision-making systems, including Australia, Canada, England, France, Germany, Scotland, Spain, the US and Italy, as well as of key national organizations (NHS Digital, the International Consortium for Health Outcomes Measurement, and 4Core Outcome Measures in Effectiveness Trials) and initiatives (Health Outcomes Observatory [H2O] and AHRQ). A snowballing approach was applied to identify additional publications related to the research question to ensure all relevant articles were identified.

All searches were conducted by a trained reviewer and validated by a second, senior reviewer. Title/abstract and full-text screening were carried out by a single reviewer with a second reviewer conducting a quality check of 15% of excluded articles. All included publications were validated by a senior researcher. Data extraction of included studies was carried out in a pre-specified template by a single reviewer and validated by a second reviewer based on thematic analysis.

Screening and data extraction

The thematic analysis of publications mapped findings to three key topics of interest: (1) benefits/barriers at the patient level, (2) benefits/barriers at the clinical level, and (3) challenges at the healthcare service level for the integration of PROMs into clinical workflows.

Results

The database searches yielded 1,846 hits. After deduplication and removal of conference abstracts, 1,280 articles were reviewed at the title/abstract level, of which 1,266 were excluded, leaving 14 articles for full-text review. An additional 14 articles were identified as part of snowballing efforts, resulting in 28 articles undergoing full-text review. Of these, 15 were excluded, leaving 13 articles [17,18,19,20,21,22,23,24,25,26,27,28,29] for inclusion in the review. The most common reason for exclusion was that the article was not publicly available (n = 5) or that it was not published within the eligibility period (n = 3). Other studies focused on topics such as PRO software, healthcare costs, and provider performance, which was beyond the scope of this review. The manual search of key websites did not identify any relevant publications. The literature attrition is provided as a PRISMA diagram in Fig. 1.

Fig. 1
figure 1

Literature attrition diagram. Abbreviation: PRO patient-reported outcome

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Findings from eligible articles were categorized into three main thematic areas examining benefits and/or barriers at each of the patient level, clinician level, and healthcare service level. An overview of the results is shown in Fig. 2 with more detail provided in the sections below.

Fig. 2
figure 2

Benefits and barriers in PROMs use in clinical care across stakeholders. Abbreviations: PRO patient-reported outcome; PROM patient-reported outcome measure

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Benefits at the patient level

Six studies [18,19,20,21, 23, 26] addressed the benefits of PROM incorporation at the patient level. A common theme among these studies was the ability of PROMs to improve the patient’s experience in times of illness and treatment but also to better highlight the patient’s perspective on their symptomatology, their condition, and their care.

In their recent scoping review, Silveira Bianchim et al., 2023 [23] reported that PROMs were universally considered to have the potential to drive increases in patient satisfaction (i.e., with treatment and services), in patient awareness (i.e., of symptoms and self-management) and in improving outcomes such as quality of life and global health status. They cited completion rates ranging from 30 to 100% but also stated that 92% of patients agreed that PROMs are generally easy to understand and that 76% saw routine inclusion of PROMs in a positive way. Generally, these authors proposed two main theories regarding the benefits of PROMs: (1) the promotion of proactive communication and positive health behaviors, and (2) the increase in clinician awareness of patients’ symptoms.

Similarly, Mejdahl et al., 2020 [18] identified several benefits to the patient-clinician relationship, including the prompting of a wider scope of dialogue, encouraging patients to express emotions during visits and influencing the balance of power during the visit. Ruseckaite et al., 2022 [20] also highlighted improved communication between clinician and patient in their study, noting that a potential role of PROMs is to “facilitate shared decision-making” between the patient and clinician and to support efforts in patient-centered care. They further hypothesized that a unique benefit of PRO data is the ability to apply the information in real time unlike diagnostic testing which is rarely performed in this manner. As a result, the immediacy of PRO data can provide the clinician with valuable subjective (patient) information to augment the objective data from diagnostic tests and provide the patient with an avenue to provide additional information during visits, which ultimately may enhance shared decision-making in clinical practice.

The use of PROMs as a method for improving clinician-patient communication was noted in two other studies. In Greenhalgh et al., 2017 [26], PRO data were observed as a method for patients to express their thoughts without uncomfortable discussions, which is particularly beneficial to reserved patients who prefer not to discuss personal or sensitive issues. Reaney et al., 2015 [19] previously discussed this subject by highlighting the difference in perception that exists between patients and healthcare providers regarding treatments and outcomes. They point out the importance of incorporating PROMs into clinical care in a manner that will maximize the validity and acceptability of the data, while ensuring that the patient’s perspective is adequately provided to all stakeholders. Finally, Sawatzky et al., 2021 [21] referred to patient-level effects as “micro-level” implications and proposed that PROMs could provide different treatment options or goals of care and ultimately impact the continuation or addition of interventions. They recommended that PRO data be interpreted with the patient in dialogue to maximize the possibility of a response shift.

Barriers at the patient level

Three studies [18, 23, 26] discussing barriers to widespread PROM adoption at the patient level were identified. These papers were headlined by basic “uncertainty on how PROMs work” (logistically and practically) and how to best implement PROMs to self-manage their healthcare [23]. Mejdahl et al., 2020 [18] identified three specific barriers to PROM adoption: (1) variability in how clinicians apply PROMs during visits, (2) lack of follow-up on problems identified by PROMs, and (3) unfulfilled patient expectations owing to PROMs. Additionally, Greenhalgh et al., 2017 [26] noted challenges in the use of standardized versus individualized PROMs. While standardized PROMs were considered to be helpful for many patients, especially those, as discussed earlier, who were unlikely to discuss personal or sensitive issues with their clinician, individualized PROMs were found to be less useful. Individualized PROMs were found to be less able to judge change over time, owing to differences in the ways that cues were “defined by different patients, between patients and interviewers and over time.” The consensus regarding barriers to widespread PROM adoption thus skew not toward the potential value of PRO data but to the logistical barriers in collecting, applying, and interpreting PRO data in a meaningful and beneficial way.

Benefits at the clinical level

Nine papers [17,18,19,20,21,22, 26, 28, 29] discussed the benefits or barriers associated with PROMs from the clinician perspective. In general, most authors identified the ability of PRO data to clarify symptomatology and inform clinical decision-making as the most crucial benefits. Schick-Makaroff et al., 2019 [22] documented this in their study of PROMs in kidney care, cataloguing specific responses or recommendations from registered nurses based on patient recorded quality-of-life data. Alterations in care ranged from no change (i.e., maintain current treatment regimen) to medication changes, referrals to paramedical colleagues (i.e., dieticians) to encouraging home exercise programs. Important was the observation that “no change” in care was viewed as a positive interaction, as it indicated that benefits were being seen from the existing treatment approach.

Reaney et al., 2015 [19] and Ruseckaite et al., 2022 [20] both highlighted the brief nature of physician-patient encounters and the inherent value of PROMs in providing supplemental information and helping to differentiate treatment options, beyond efficacy and safety alone, in order to address patient-specific concerns. Ruseckaite et al., 2022 [20] further discussed this tailored approach to treatment, particularly the value of real-time interpretation of PRO data, where the immediate review and interpretation of PRO data by the clinician allows for more rapid responses to changes in the patient’s status and a more individualized patient experience. This is echoed elsewhere by suggestions that PROMs can improve the clinician-patient relationship by allowing clinicians to better understand patients’ symptoms and their specific effect on each individual patient [26, 28].

Finally, several authors [17, 19,20,21, 23, 26,27,28] commented on the ability of PROMs to increase physician satisfaction by leading to improved patient outcomes and overall efficiencies in the patient care pathway, suggesting that improvements in well-being may extend beyond that of the patient and could also include the clinician [28]. Per-visit savings of between five and 10 min were noted with the use of electronic PRO surveys prior to appointments [28]. This was accompanied by a greater ability of the clinician to focus on the examination and communication with the patient. This is captured well in Sawatzky et al., 2021 [21] who termed clinician-related effects as the “meso-level.” The authors suggested that improvements in clinician performance can be seen via performance monitoring of PRO data, resulting in quality improvements which may in fact extend beyond the clinician level and may also play a role in the accreditation process for healthcare organizations as a whole.

Barriers at the clinical level

Chief among the barriers identified from the physician perspective was the concern regarding the feasibility of integrating PRO data into daily patient care [29]. The complexity in establishing routine collection of PRO data and potential tension among stakeholders regarding the different uses of PRO data (i.e., for competing purposes) are the main drivers of hesitation. Despite these challenges, Van Der Wees et al., 2014 [29] reported that participants in their survey/interview study emphasized the value of “just getting started” and that rather than remaining paralyzed by indecision, clinicians should begin utilizing PRO data as much as possible and use that momentum to identify and overcome hurdles as they are encountered. Related to this, the variation in clinicians’ applications of PROMs and PRO data during visits has been identified as a potential barrier, as has the lack of follow-up on problems identified in PRO data [18]. In one study, only 15 of 23 physicians (65%) opened the PROM consultation document on their computer during patient visits and, among those who did view PRO data, the degree to which PRO data or results were articulated to the patient varied widely [18]. These barriers all reflect the general attitude that the collection of PRO data is essential on a theoretical level, although the practical application of data collection and implementation – and the associated changes in clinical decision-making – remain in the developmental stage.

Challenges at the healthcare service level for the integration of proms into clinical workflows

Three papers [21, 24, 27] examined the use of PROMs in decision-making at a healthcare system level. Central to the proposed benefits to the healthcare system are potential improvements in efficiency associated with the use of PRO data.

Spertus et al., 2024 [24] highlighted this benefit by suggesting that the ability of a clinician to assess and score a PROM before meeting with the patient allows the clinician to begin the visit informed as to the patient’s status and any recent changes to their health, which can save time during the visit itself. There is also a potential role for PRO data to be coupled with emerging telehealth treatment options, where PRO data can provide a rapid update on patient status and further streamline the virtual clinician-patient interaction. They raised additional points, such as the potential bias created by PRO surveys being completed only by survivors. If the treatment intervention in a randomized trial results in increased survivorship compared with placebo, patients in the poorest health are more likely to survive as part of the treatment group than as part of the control group. As a result, the average health status in the treatment group would appear to be lower than the control group, owing to the presence of sicker patients who survived in the intervention group. This may then give an inaccurate portrayal of the value of the treatment, from a PROM perspective. The authors also commented on the difficulties with between-group interpretation, noting that in a common survey such as the Kansas City Cardiomyopathy Questionnaire, a between-group difference of only 2.5 points (less than half of the clinically important difference) can reflect asymmetric distribution of patients in comparator groups. The authors pointed to a recent CMS proposal that recommends that collecting serial PROMs should be part of quality assurance measures by healthcare systems, citing this as further evidence of the potential benefit of PRO data.

Sawatzky et al., 2021 [21] referred to system-wide benefits or effects as the final or “macro-level” tier in their multi-level examination of PROMs. They suggested that PROMs can influence health policy decisions, including healthcare coverage and the provision and reimbursement of health services. They indicated that the potential shift in response caused by the addition of PRO data would center around the unmet needs – both healthcare and service related – of the population. They further recommended that decisions influenced by PRO data critically reflect on the conceptualization of health as part of a broader approach to decision-making at the healthcare system level.

Porter et al., 2016 [27] examined the potential challenges to the healthcare system with regard to PRO collection and use, concluding that there is evidence from systematic reviews to indicate that PROMs can impact the processes of care but that there is less compelling evidence of their ability to actually impact outcomes of care. The authors attributed this to a lack of “link-up” between PROMs and clinical decision-making, stating that there are currently limitations on how to interpret measures and how they can be used to directly influence clinical decision-making.

A summary of these findings is presented in Fig. 2.

Discussion

The added value of the patient voice in healthcare decision-making has been widely acknowledged, yet the implementation of PRO data in routine clinical care has been fragmented. This scoping review aimed to identify and summarize the benefits of and barriers to rooting PROMs in the healthcare lifecycle from both the patient and clinician perspectives. A critical examination of the evidence was performed with the aim to evaluate the current thinking around this issue and set forth related policy enablers for the benefit of a wide variety of organizations.

The transformative potential of PROMs in improving patient care and driving healthcare reform was underscored by all the included publications. The use of PROMs was considered to enhance the patient-provider relationship, improve communication and promote shared decision-making by facilitating a wider scope of discussion during the patient-clinician interaction.

From the patient perspective, PROMs can play a valuable role in enabling patients to more actively engage in their healthcare. At a minimum, PROMs allow for increased awareness of their symptoms, their condition, and as an opportunity to raise concerns about their care. Several studies noted that, during the process of completing a PROM, patients felt more at ease discussing uncomfortable topics and can encourage self-reflection by articulating issues regarding either their condition or care received that would not have been apparent in a typical consultation. In turn, this has the potential to empower patients to raise these concerns with clinicians, shifting the balance of power toward the middle and giving a greater foundation to the patient voice [18, 23]. Although not clearly presented by the included studies, PROMs completed during healthcare encounters can play a significant role in transforming the traditional disease-focused paradigm in healthcare to a positive health behaviour model by bringing to light with the impact of social determinants of health (e.g., poverty, employment, education) or other cultural/background considerations on health and disease outcomes [30].

Barriers to widespread PRO adoption at the patient level related to a lack of certainty on the purpose of PROMs, how they work, and how they best can be used to self-manage care. One important gap highlighted in the studies was how PROMs created an expectation on the part of patients for clinicians to take action on their PRO data, and a lack of actionable response often left patients feeling “unfulfilled.” As pointed out by Mejdahl, et al., 2020 [18], however, there is variability in patient involvement when PROMs are in play, and the aforementioned benefits are not automatic. Efforts to standardize the collection, application, and interpretation of PRO data in a meaningful and beneficial way will help address some of these logistical issues and potentially increase wider uptake of PROMs.

From the clinician perspective, there was consensus on the ability of PRO data to clarify symptomatology and inform clinical decision-making which can result in higher-quality visits by providing additional information and perspective on the patient’s current status, their experience and/or progression since the previous interaction. Several studies emphasized the importance of PROMs as supplementary data that can be a differentiator of treatments with similar efficacy and safety profiles, and the value of real-time interpretation of PRO data to provide patients with a more personalized experience.

On a theoretical level, the integration of PROMs into daily patient care is essential. In reality, as is known from implementation science and change management [31], it is a time-consuming, logistically challenging process that requires buy-in from clinicians for it to become an effective gear in the workflow. In addition, stakeholders are often at odds with the competing objectives of the uses of PRO data. In a 2014 survey/interview study [29], participants suggested that clinician indecision on the use of PRO data could be effectively addressed by just diving into the process as a way to see its inherent value.

At the healthcare system level, evidence was strong for how the use of PROMs improves the processes of care but the ability to draw a direct connection between PROMs and improvement in outcomes was limited. This is an important observation, as the majority of the evidence in the current review supports the use of PROMs as a method to improve patient-clinician communication and increase the overall pool of information available to clinicians, although few of the papers cited in this review provide evidence of improvements in outcomes. Spertus, et al., 2024 [24] concluded that insurance reimbursement for PROMs offered the greatest possibility to increase their use and emphasize PROMs as inexpensive, accurate tools that could be leveraged by healthcare systems.

Overall, although some studies in this review provided data to back up their claims, a number of eligible studies were descriptive in nature. Since a lack of empirical evidence regarding the ability of PROMs to actually improve outcomes is cited by several authors as a concern and/or source of hesitation, the lack of data-driven studies is disappointing. While commentaries, surveys, and interview studies provide anecdotal evidence, the use of PROMs in regular clinical practice requires objective data to continue to push forward. This gap is highlighted further when considering the emerging use of clinimetrics, i.e., the science of clinical measurements, in assessing the subjective experience of care, which may guide the planning, implementation, and monitoring of personalized treatment strategies in future [32, 33]. The use or PROMs is a cornerstone to this effort will be stalled without data-driven work. As such, it is incumbent upon researchers to focus on this aspect of PROM research going forward.

Although the concept of PRO data remains promising, clearly, there remain significant barriers to its routine and widespread adoption. This is not surprising, however, since the path from innovation to implementation is often a long one [34]. For example, the gap between the introduction of electronic health records in the hospital setting and their widespread use spanned 50 years [34]. Building upon the harmonization efforts of AHRQ, the standardization of outcome measures is a crucial step in accelerating value improvements in healthcare. Collaborations such as the H2O project promote health data as an essential resource that should be accessible to all legitimate stakeholders [35]. The project, which is a partnership of university hospitals, patient organizations, and the pharmaceutical industry, can offer patients the opportunity to control their data in a safe and standardized way, which is an integral component of facilitating widespread adoption of the use of PRO data across the healthcare spectrum.

Limitations

This study followed rigorous methodology to identify articles from the most used databases. However, the wide-ranging language used to describe PROMs and the wide variety of PROMs that are in or recommended for use made searches difficult to conduct. The ambiguity of language may result in some articles being missed, although more than 1,800 initial hits were identified, providing a suitably large pool for screening. The database searches were augmented with snowball searching of important commentaries, which provided a robust group of eligible articles.

Conclusions

PROMs have a long history of use in clinical research; however, their use in everyday practice is growing and the benefits to the patient, the clinician, and the healthcare system itself are many. Much evidence supports the ability of PROMs to improve patient-clinician communication, improve satisfaction in both patients and clinicians, to promote shared decision-making, and to improve resource utilization.

There has been hesitation; however, in the widespread implementation of PROMs in practice, due largely to the unfamiliarity of both clinicians and patients regarding the practical use of PROMs, the difficulty in finding a “starting point” for clinicians and, importantly, a lack of objective evidence to indicate that PROMs improve objective outcomes.

More objective data are needed to further define the intended outcomes of PRO integration in clinical care. Strategic alliances that can promote governance frameworks will be integral in supporting the unique, but interrelated needs at the patient, clinician, and healthcare system levels to fully implement the concept of value-based, equitable healthcare.