Patient-reported Outcome Measures in Solid Organ Transplant Recipients: Current use, Challenges, and Recommendations for Future use

Abstract

Worldwide, the number of patients receiving solid organ transplantation each year is increasing. In recent years, there has been growing recognition of the need to understand how these additional life years are experienced and valued by recipients. Patient-reported outcomes (PROs)—such as symptoms, functioning, and health-related quality of life—provide direct insight into health from the patient’s perspective and are increasingly acknowledged as key outcomes in both research and clinical care. Different patient-reported outcome measures (PROMs) have been developed in the field of transplantation. However, their current use in both clinical care and research in solid organ transplant recipients remains inconsistent and limited. This narrative review summarizes the current state of PRO and PROM use in solid organ transplantation across different organs and settings, highlights recent initiatives and ongoing implementation efforts, and outlines challenges in PROM selection, application and interpretation. Although the field of kidney transplantation is currently leading in the development and implementation of PROM initiatives, comparable efforts in liver, lung, and heart transplantation remain limited, resulting in slow and heterogeneous progress across organ domains. To support broader adoption, we propose a stepwise roadmap for PROM implementation in transplantation. A more systematic and thoughtful integration of PROs and PROMs holds potential to improve shared decision-making, generate evidence that aligns more closely with the priorities of transplant recipients, and ultimately support more meaningful clinical decisions and improved outcomes for transplant recipients.

INTRODUCTION

“The patient is the center of the medical universe around which all our works revolve and towards which all our efforts tend”—John Benjamin Murphy (1857–1916), Professor of surgery, Chicago. Although this quote dates back >100 y, the importance of outcomes reported directly by patients themselves has only been recognized in recent decades.¹ A patient-reported outcome (PRO) is a measurement of any aspect of a patient’s health that comes directly from the patient, that is, without the interpretation of the patient’s responses by a physician or anyone else.² A patient-reported outcome measure (PROM) is a structured tool, such as a questionnaire, which allows these outcomes to be captured.³ PROMs can be classified as either generic or disease-specific instruments. Generic PROMs assess universal aspects of health and well-being and can be applied across a broad range of patients, conditions and treatments.⁴ Disease-specific PROMs assess aspects of health and well-being that are specific to a particular disease, condition or treatment, and are designed for use in specific patient groups.³

PROMs, in the context of medical care, were initially used in research, particularly in clinical trials evaluating treatment effectiveness. Over time, their use has expanded to support clinical decision-making, compare outcomes between healthcare providers, encourage quality improvement, and assess practices and policies.¹

In clinical care, PROMs have been found to encourage self-reflection of patients, to assist in identifying patients’ needs and priorities, and to support more active patient engagement in managing their own health.⁵ PROMs also enhance clinician awareness of patient symptoms and symptom burden and contribute to shared decision-making.^5,6 Moreover, they improve patient-provider communication and increase patient satisfaction.¹ As demonstrated in studies conducted among patients with cancer, this may ultimately lead to important improvements in health outcomes, such as better health-related quality of life (HRQoL), less visits to the emergency room, and better overall (quality-adjusted) survival.^7,8

In 2023, a total of 172 409 patients worldwide received a solid organ transplantation (SOT), an increase of 9.5% compared with 2022.⁹ SOT is associated with significant survival benefits, resulting in millions of life years gained.¹⁰ Moreover, HRQoL generally improves after SOT.¹¹ However, in the long-term, HRQoL remains lower compared with the general population, often compromising health aspects such as physical functioning, bodily pain, general health, and role limitations duo to physical problems.^12-14 Symptom burden is high among all types of SOT recipients, with many symptoms linked to the unavoidable use of immunosuppressive drugs.¹⁵ A recent study in kidney transplant recipients showed that a higher number of symptoms is associated with lower physical and mental HRQoL, and that this influence is partially mediated by patients’ beliefs about their condition (ie, unhelpful illness perceptions such as a perceived lack of knowledge or personal control).¹⁶ Furthermore, emotional symptoms such as anxiety and depressive symptoms can affect up to 20%–60% of SOT recipients and are associated with increased mortality, de novo malignancy, noncompliance, and graft loss.¹⁷ Additionally, poor sleep quality is highly prevalent among SOT recipients and is frequently associated with anxiety and depression, lower quality of life, and higher comorbidity.¹⁸ Also, sexual symptoms are highly prevalent among kidney transplant recipients, these are considered the most burdensome symptoms, and their prevalence is negatively associated with HRQoL. Yet, these symptoms are often underrecognized and remain undiscussed and un(der)treated in clinical practice.¹⁹

These findings highlight the critical need not only to extend life through transplantation but also to improve HRQOL in the additional years gained. The inclusion of PROs and the use of PROMs represent essential tools to achieve this.

Recognizing this need, recent efforts have emphasized the importance of incorporating PROs in transplantation research and clinical practice, but so far these have been limited to kidney transplant recipients.^20,21 One key initiative is the “Standardized Outcomes in Nephrology-Transplantation” (SONG-Tx); an international project aimed at developing a core outcome set for kidney transplantation trials, based on shared priorities among all stakeholders.^20,22 Another international working group of healthcare providers and patient representatives that underscores the importance of PROs, is the “International Consortium for Health Outcomes Measurement.” This consortium developed a standardized minimum set of PROs—and provided guidance on which PROMs to use to captures these PROs—for patients with chronic kidney disease (CKD), including transplant recipients, targeted for clinical use.²¹

Despite these efforts, the use of these sets—or the routine collection of PROs in general—is not yet common practice.

In this narrative review, we aimed to give an overview of the current use of PROs and PROMs in SOT recipients, identify challenges to their implementation, and provide practical recommendations for this implementation. Although the use of PROs and PROMs are also highly relevant in the care of transplant candidates and living donors, these populations fall outside the scope of the present review.

CURRENT STATE OF THE FIELD

Current use of PROs and PROMs in Studies in SOT

Several reviews have evaluated the extent to which PROs and PROMs have been included in different types of studies across different transplant populations. For example: in kidney transplantation, <3% of 397 randomized controlled trials (RCTs) (published between 1974–2015; protocols between 2010 and 2016) reported on PROs, most often pain, fatigue, sleep problems, adherence, and quality of life.²³ In liver transplantation, PROs were included in 13% of 55 published RCTs and 17% of 24 ongoing RCTs (2013–2018), with “symptoms” being most common in published and “quality of life” in ongoing trials.²⁴ In lung transplantation, 20% of 20 interventional and 10% of 31 observational prospective studies (all published in 2019) captured PROs, primarily HRQoL, pain, neuropsychological and pulmonary symptoms.²⁵ In heart transplantation, PROMs were reported in 12% of interventional and 9% of observational studies registered between 1999 and 2022, mostly HRQoL and cardiac symptoms; importantly, inclusion rose to 34% in studies initiated after 2020.²⁶

The scope of studies investigating PROs as primary or secondary endpoints in SOT patients is quite diverse. Interventional trials have evaluated the effectiveness and side effects of immunosuppressive and other drugs,^27-32 lifestyle, training, and rehabilitation interventions,^33-37 mindfulness-based therapies,^38,39 adherence interventions,⁴⁰ and digital tools.^40-42 Observational studies have compared PROs across patients groups with or without specific conditions or medications,^43-46 with the general population,^47-50 and in relation to outcomes such as mortality,^18,51-53 or tracked changes within individual patients over time.^47,54-59

Despite this breadth, the overall use of PROs in transplantation studies remains limited, with most focusing on HRQoL or a small set of symptoms. Encouragingly, the inclusion of PROs seems to have increased in recent years, but systematic use is still lacking. Future research should build on this positive trend by consistently incorporating PROs as core outcomes.

PROMs Used in Studies and Related Research Initiatives

The PROMs used to measure PROs in SOT studies are highly diverse. For instance, Ju et al⁶⁰ identified 29 different PROMs across only 16 SOT studies,⁶⁰ whereas a systematic review in heart transplantation reported 115 different PROMs in 102 studies.⁶¹ Generic tools, particularly the 36-Item Short Form Health Survey (SF-36) and the EuroQol 5-Dimension, are most frequently applied across organ groups. In kidney transplantation, the SF-36 also dominates, alongside the specific Kidney Disease Quality of Life questionnaire and the World Health Organization Quality of Life questionnaire.^12,26,62 Despite the availability of at least 26 validated transplant-specific PROMs⁶³ their actual use remains limited (only ~ 13% of used instruments^26,62). See Table 1 for a complete overview.

TABLE 1.

Properties of most frequently used PROMs per transplant population

PROM	Usage in kidney/heart/liver transplant recipientsa	Generic or disease-specific	Domain coverage
36-item Short Form Health Survey	Kidney: 61%12 Heart: 42%26 Liver: 30%62	Generic	HRQoL Physical functioning Role limitations (physical) Bodily pain General health perceptions Often grouped as a “physical component score” Vitality Social functioning Role limitations (emotional) Mental health Often grouped as a “mental component score”
Kidney Disease Quality of Life	Kidney: 18%12	Disease-specific with generic HRQOL-component	HRQoL; Includes the SF-12 (the short version of the SF-36), supplemented with: Burden of kidney disease Symptoms Effect of disease
EuroQol-5 Dimensions	Heart: 25%26 Liver: 18%62	Generic	HRQoL/health status Mobility Self-care Usual activities Pain/discomfort Anxiety/depression
Chronic heart failure HRQoL questionnaire	Heart: 21%26	Disease-specific	HRQoL Physical functioning Cognitive functioning General health Mental health
World Health Organization Quality of Life assessment	Kidney: 16%12 Liver: 5%62	Generic	HRQoL Physical health Psychological health Social relationships Environment health
Nottingham health profile	Liver: 16%62	Generic	HRQoL Sleep Energy Physical mobility Pain Emotional reactions Social isolation

^aUsage percentages reflect the proportion of studies using each PROM in different types of literature: for kidney transplant recipients: studies describing HRQoL in kidney transplant recipients; for heart transplant recipients: clinical studies in heart transplant recipients using PROMs; for liver transplant recipients: studies on liver transplant candidates and recipients addressing PRO(M)s.

HRQoL, health-related quality of life; PRO, patient-reported outcome; PROM, patient-reported outcome measure.

The importance of incorporating PROs as endpoints in clinical trials for SOT recipients has been widely recognized. Patients, caregivers, and healthcare providers united in the previously mentioned SONG-Tx initiative,²² collectively concluded that PROs should be a core outcome domain in kidney transplantation trials. Within this initiative, the patient-prioritized domain of “life participation” (ie, the ability to engage in meaningful activities) was proposed as such a core outcome, and a specific PROM—the SONG Life Participation (SONG-LP)—has recently (2023) been developed and validated for kidney transplant recipients.⁶⁴ To date, no studies applying this PROM have been published.

Comparable initiatives are largely absent in other organ domains. In liver transplantation, an international working group was proposed in 2020 to develop a core outcome set including PROs, but no progress has since been reported in the literature.²⁴ Meanwhile, the European Society for Organ Transplantation called for a core set of validated PROMs co-produced with patients, and relevant across the liver transplant journey, though this remains to be operationalized.⁶⁵ In heart transplantation, efforts have begun to develop a patient-centered PROM via registry studies,⁶¹ while in lung transplantation no such initiatives exist, although the need to move beyond mortality as an outcome has been emphasized.⁶⁶

Together, these findings illustrate the slow and heterogeneous progress across organ domains, underscoring the need for coordinated PROM development and application in research.

Current use of PROMS in Clinical Practice and Developments

The extent to which PROMs are currently integrated into clinical practice for SOT recipients is not well established. It is likely that initiatives exist at local or institutional levels that have not yet been captured in the published literature.

A separate systematic review of SOT quality indicators found that only 4% of 114 defined metrics were PROMs, underscoring their limited role in practice.⁶⁷ However, a trial in lung transplant recipients showed that PROM feedback increased HRQoL discussions and led to meaningful differences in patient management, although no improvement in overall HRQoL was observed at 6 mo.⁶⁸ These results are in line with a Cochrane review (2021) of 116 randomized trials on the routine provision of feedback from PROMs to healthcare providers and patients in clinical practice.⁶⁹ The review concluded that PROM feedback probably improves quality of life, enhances patient–physician communication and disease control, and makes it twice as likely that patients receive either a relevant diagnosis or a relevant notation in their medical record.⁶⁹

PROMs have been implemented into routine dialysis care in the Netherlands since 2018, demonstrating feasibility. A study describing this first experience showed that patients perceived discussing their HRQoL and symptom scores as insightful and valuable, indicating that PROM use at the individual patient level is suitable.⁶ Following this initiative of routine PROMs implementation, the “Patient-reported OutcomeS In kidney Transplant recipients: Input of Valuable Endpoints (POSITIVE) study” was initiated in several Dutch hospitals.⁷⁰ This ongoing study explores the implementation of PROMs in kidney transplant recipients, learning lessons from the implementation in routine dialysis care and aligning with the PROMs used in routine dialysis care to ensure comparability and longitudinal follow-up. Qualitative and quantitative results are expected in 2026, hereby contributing to our understanding of PROMs implementation in kidney transplant recipients.^16,19,71

In addition to alignment across different phases of nephrological care, alignment within the broader SOT field is also needed. The PROMs Transplant Care project is an initiative by the Netherlands Transplantation Society and the Dutch Transplant Foundation. The project aims to establish and implement a standardized set of PROs and PROMs for both clinical care of SOT recipients and registration purposes. The implementation of the PROMS is set to begin in the second half of 2026.

Together, these findings illustrate that while isolated initiatives demonstrate feasibility and potential value, robust evidence on effectiveness, sustainability, and optimal implementation strategies in SOT is still largely missing. Future research should therefore focus on rigorous trials and implementation studies that address reliability, resource requirements, and real-world clinical impact of PROM use.

CHALLENGES

Choice of PROs and PROMs

The greatest challenge arises from the vast number of both generic and disease-specific, as well as transplant-specific, PROs and PROMs, leading to choice overload. While it is evident that HRQoL and symptoms are the primary PROs, selecting which PROM best captures the desired outcomes can be challenging.

However, a few international guidelines provide structured recommendations for the selection, integration, and reporting of PROs in clinical trials and their protocols^72–75 (see Tables 2 and 3 for a complete overview).

TABLE 2.

Initiatives regarding PRO(M) use in research and implementation in clinical practice—general

Initiative (organization/initiators)	Description
Consensus-based Standards for the selection of health Measurement Instruments initiative, in collaboration with the Core Outcome Measures in Effectiveness Trials initiative	Published a consensus-based guideline for selecting outcome measurement instruments (including PROs) for use in core outcome sets in clinical trials.72
International, consensus-based Standard Protocol Items: Recommendations for Interventional Trials-PRO extension	Provides guidance on items to include in clinical trial protocols when PROs are primary or key secondary outcome.73,74
Consolidated Standards of Reporting Trials-PRO extension	Provides recommendations for reporting PRO results in randomized clinical trial publications.75
Patient-Reported Outcomes Measurement Information System International Collaboration	Developed a standardized system of PROMs based on item response theory, covering physical, mental, and social health, for use across various health conditions, languages, countries, research, and clinical care.76
Food and Drug Administration	Actively encourages and supports the use of PROMs in clinical trials and regulatory decision-making, particularly for substantiating labeling claims.2
European Medicines Agency	Highlights the systematic integration of PROs as a key goal in its “Regulatory Science Strategy to 2025,” aiming to promote patient-centered drug development and informed benefit-risk evaluation.77
American Society of Transplantation–Patient-Focused Drug Development initiative	Commissioned the development of a comprehensive survey to capture transplant recipients’ unmet needs and treatment experiences with immunosuppressive therapy, aiming to advance PROMs as formal clinical trial endpoints and guide future regulatory acceptance.78

PRO, patient-reported outcome; PROM, patient-reported outcome measure.

TABLE 3.

Initiatives regarding PRO(M) use in research and implementation in clinical practice – organ specific

Initiative (organization/initiators)	Description
Standardised Outcomes in Nephrology-Transplantation (kidney)	International initiative to develop a core outcome set for kidney transplantation trials, based on stakeholder consensus. Identified PROs (including “life participation”) as essential outcomes. Developed a PROM for life participation; the SONG-Life Participation instrument.20,22,64
ICHOM CKD Standard Set (CKD, including kidney transplant recipients)	International collaboration of professionals and patients. Developed a minimum set of PROs, and recommended PROMs for use in clinical care for patients with CKD, including transplant recipients.21
Patient-reported OutcomeS In kidney Transplant recipients: Input of Valuable Endpoints study (kidney)	Dutch multicenter implementation study exploring routine PROM use in kidney transplant recipients. Aligned with PROMs used in dialysis care to enable longitudinal follow-up. Results expected in 2026.70
PRO-GUIDE project (nephrology, including SOT relevance)	Dutch initiative developing a generic PROMs toolbox, and a communication and symptom-treatment PRO-guide to support healthcare professionals in responding and acting on PROM results in clinical care for patients on dialysis. Focuses on symptoms also highly relevant to SOT recipients (eg, fatigue, sleep, mental health, sexual problems).79,80
Brustia et al (liver)	Proposed an international working group to develop a core outcome set for liver transplantation including PROs.24 No follow-up reported.
ESOT consensus statement on outcomes measures in liver transplantation (lver)	Proposed a value-based health care framework and emphasized co-development of a core set of validated, phase-specific PROMs for use in trials and clinical care. Recently published (2024); no implementation yet.65
Mahmoudi et al (heart)	Published a review as a first step in a mixed-method study to develop a patient-centered PROM for heart transplant recipients.61
PROMS Transplant Care project (all SOT recipients)	Dutch initiative to define and implement a standard set of PROs and PROMs for all SOT recipients, for use in both clinical care and national registration. Implementation planned for 2026.

CKD, chronic kidney disease; ESOT, European Society for Organ Transplantation; PRO, patient-reported outcome; PROM, patient-reported outcome measure; SOT, solid organ transplantation.

The question of how to select a PROM specifically for clinical trials involving SOT patients has been explored by Ju et al.⁶⁰ The authors emphasize that selecting a PROM requires careful alignment with the target population, research question, and the specific intervention under study. Their proposed stepwise approach begins with identifying PROs that are both meaningful to key stakeholders—such as transplant recipients, caregivers, and healthcare providers—and relevant to the intervention. Once the key PROs have been identified, suitable PROMs can be selected based on their feasibility, relevance to the population, and evidence of reliability, validity, and responsiveness.

The literature shows that disease- and transplant-specific PROMs used to assess quality of life in SOT recipients show substantial heterogeneity in their development, content, and quality.⁶³ This includes wide variation in the extent of patient involvement during development, the HRQoL domains covered, and the methodological rigor of validation studies. Such heterogeneity complicates the comparison of outcomes across studies and makes it challenging to select the most appropriate PROM for a specific context.⁶³

This heterogeneity underscores the urgent need for consensus on which PROs and PROMs should be used, to enable comparability and support consistent implementation in both research and clinical care.

The patient-reported outcomes measurement information system (PROMIS) is a globally used, important example of international standardization of PROs and PROMs.⁷⁶ PROMIS is a standardized measurement system comprising a broad range of item response theory-based PROMs, developed from item banks. It is designed to assess commonly relevant generic aspects of physical, mental, and social health in both adults and children across various health conditions, languages, and countries.⁷⁶ Its use has steadily increased in recent years.⁸¹ In this measurement system, PROMs can be administered through computerized adaptive testing, which tailors question selection based on individual responses, or as fixed short forms (ie, nonadaptive testing). The generic short forms can be supplemented with disease-specific PROMs, although these are not part of the PROMIS item banks and need to be added separately. However, the use of computerized adaptive testing may pose challenges for certain populations—especially those with limited digital skills—potentially affecting accessibility, ease of use, and validity of responses.

The PROMIS-57, a 57-item questionnaire assessing 7 health domains, and the PROMIS-29, a shorter 29-item version embedded within it, have demonstrated strong reliability and validity in kidney transplant recipients.⁸² A validation study in heart transplant recipients has supported the reliability and validity of 4 PROMIS domains: physical function, fatigue, depression, and social functioning.⁸³ PROMIS has not been validated in liver and lung transplant recipients, although it has already been used in these populations.^84,85

PROM Score Interpretation and Application

The diversity of PROs and PROMs complicates not only comparison of results across studies, organ types, and clinical settings, but also the conduct of high-level analyses such as meta-analyses. Crosswalk tables are being developed to translate scores between instruments,^76,86-88 but interpretation of PROM scores remains challenging, especially for clinicians unfamiliar with these tools. Van der Willik et al have published an educational article on the interpretation of PROM scores, illustrated with examples from nephrology care.³ Concepts such as minimal detectable change (“the smallest change in score that can be detected beyond measurement error”), minimal important change (“the smallest change in score in the construct to be measured which patients perceive as important”), and response shift (“a change in the meaning of one’s self-evaluation, which can be a result of recalibration, reprioritization and/or reconceptualization of the PRO”) are most relevant for interpretation.³

Furthermore, it is crucial to provide healthcare providers with tools to discuss PROM results effectively and act upon them, because HRQoL and symptom burden often remain undiscussed and un(der)treated in routine clinical practice, because of sensitivity of topics, assumptions about relevance, or time constraints.⁸⁹

Although not SOT-specific, lessons can be learned from the field of nephrology. A qualitative study in the dialysis population provided insight into how PROM results can be discussed,⁸⁹ forming the basis of the “PRO-GUIDE” project.⁷⁹ This initiative aims to develop a patient-centered symptom-management guide and PROMs toolbox to support communication and evidence-based management of PROM results. Although developed initially for dialysis patients, its aims to develop general PROMs tools suitable for different contexts and focuses on common symptoms such as fatigue, sleep, sexual, and mental problems makes it equally relevant for SOT recipients.^15,80,90 Importantly, the first tool to support healthcare providers in discussing PROM results is already available in Dutch and English.⁷⁹

To maximize the value of PROMs in transplantation, future efforts should focus on developing interpretation methods and practical tools that enable clinicians to act on results in routine care. Ideally, PROM use should follow a continuous cycle: assessing PROMs, discussing results with patients, addressing identified symptoms through targeted interventions, and monitoring their effects over time (Figure 1).

FIGURE 1.

Roadmap for the implementation of PROMs in clinical care for solid organ transplantation. The ultimate goal is to establish a continuous cycle at the patient level: assessing PROMs, discussing results with patients, addressing identified symptoms through targeted interventions, and monitoring their effects over time. PRO, patient-reported outcome; PROM, patient-reported outcome measure.

Frequency of PROM Assessment

The optimal frequency of PROM assessment in clinical care is unclear, and evidence is scarce. One qualitative study in patients with CKD found no consensus; however, patients and clinicians agreed that administering electronic PROMs more than once per month is burdensome.⁹¹ Current literature suggests aligning assessments with clinic visits, adjusting frequency to disease trajectory, and using ad hoc completion when relevant.⁹² Overall, 1 to 2 assessments per year appears reasonable, with higher frequency during interventions requiring monitoring.^70,89

RECOMMENDATIONS FOR FUTURE USE

From the above, it becomes clear that the current use of PROMs in the SOT field is still limited and highly heterogeneous across both research and clinical care. A call for broader adoption is not only driven by patients and healthcare providers, but is increasingly echoed by regulatory agencies (Tables 2 and 3). The Food and Drug Administration actively encourages the use of PROMs in clinical trials and regulatory decision-making, particularly to substantiate labeling claims.² Likewise, the European Medicines Agency, in its Regulatory Science Strategy to 2025, explicitly prioritizes patient-centered drug development, including the systematic incorporation of PROs into risk–benefit evaluations of medicines.⁷⁷ Thus, the use of PROMs is no longer merely desirable—it is steadily evolving into a requirement. In line with this trend, the American Society of Transplantation has recently initiated the development of a large-scale survey to assess transplant recipients’ unmet needs and experiences with immunosuppressive therapy. This effort, grounded in the Food and Drug Administration’s patient-focused drug development framework, underscores the importance of systematically incorporating the patient voice into therapeutic innovation.⁷⁸ At the same time, several shortcomings hinder the full integration of PROMs into SOT research and care. These include a lack of consensus on which PROs and PROMs should be prioritized, uncertainty about the optimal frequency of assessments, challenges in the interpretation of scores, and limited embedding of PROMs into daily clinical practice. Addressing these gaps is essential to move from fragmented, ad-hoc use toward coordinated and systemic application of PROMs across the SOT field.

A useful precedent can be found in the National Health Service in England, where routine PROM collection has been embedded into orthopedic care since 2009. All patients undergoing elective hip or knee replacement are invited to complete PROMs before and after surgery, with results feeding into national benchmarking.⁹³ This demonstrates that when PROMs are mandated and coordinated at scale, they can yield robust datasets that inform clinical care, policy, and research while reducing duplication of effort across centers.

More recently, 2 studies on PROM implementation—one in gender-affirming care and one in oncology—have provided concrete approaches and transferable lessons that may guide future implementation efforts in SOT.^94,95

Based on the studies described above and drawing on the general implementation framework recently developed by the Dutch Santeon hospitals⁹⁶ together with the transplant-specific strategy of the earlier mentioned Dutch PROMs Transplant Care project, we propose a structured, stepwise roadmap to guide the systematic implementation of PROMs clinical care in SOT (Figure 1).

First, (inter)national-level coordination is needed to overcome the current fragmented and heterogeneous use of PROMs in SOT. Dedicated steering committees—convened by national transplant societies in collaboration with patient organizations—should bring together clinicians, patients, researchers, and policymakers. Their mandate is to define clear goals for PROM use in transplantation, ensure feasibility across centers, and guarantee equity of access. Embedding PROMs into national registries and electronic health records will enable long-term follow-up, support comparison between centers, and facilitate secondary use for research and quality improvement.

Second, consensus must be reached on which PROs and PROMs to adopt and at which time points, addressing the lack of standardization. We propose that PROMIS measures should serve as the standard generic instruments in SOT, complemented by organ- or transplant-specific PROMs when necessary. By offering a standardized, flexible, and precise approach to measure universally relevant PROs, PROMIS enhances comparability, reliability, and efficiency in both research and clinical care. Furthermore, integration with other systems, including electronic health records is possible.⁷⁶

Third, structured PROMs-training programs for healthcare providers— such as PRO-GUIDE^79,80—will be key to ensure successful uptake. These should cover, among other things, practical skills in administration, scoring, interpretation, and patient-professional communication, including how to have (culturally appropriate) conversations about sensitive PROM results such as mental and sexual health problems.

Fourth, alignment with clinical workflows in SOT is essential to facilitate integration into daily care and to increase efficiency, ensuring that PROMs are not perceived as an extra administrative task but a time-saving clinical tool that enhances patient-centered care. PROMs should preferably be administered electronically and aligned with routine clinic visits, while offering article-based or interviewer-assisted options to ensure accessibility for all patients. The different steps in the PROM cycle—assessing patient responses, discussing results, addressing identified issues (eg, through referral to physiotherapists, psychologists, or sexologists), and monitoring the effect of interventions—can be shared within the clinical team, with responsibilities allocated according to local expertise and workflow. For example, in some centers nurses or social workers commonly discuss PROMs with patients,⁹⁷ while in others physicians take a more prominent role.

Finally, there is a need for systematic evaluation of the routine use of PROMs, as robust evidence on effectiveness and sustainability is still lacking in SOT. This requires studies that assess feasibility, uptake, clinical impact, cost-effectiveness, and long-term sustainability under real-world conditions. Such evaluations do not necessarily require individual-level randomization; designs such as pre–post comparisons, interrupted time series, stepped-wedge trials, or natural experiments across centers can provide rigorous evidence on impact and sustainability.

Recommendations for PROM use in Future Research

Beyond clinical care, PROMs should also be established as standard endpoints in clinical research. Although traditional outcomes such as graft survival and mortality remain fundamental, they do not capture the full effect of therapeutic interventions on the patients HRQoL and symptoms.

We propose that ethics committees make the inclusion of PROMs as clinical endpoints a prerequisite for approval of future clinical trials in SOT, in line with current expectations from regulatory agencies. Ideally, a core generic instrument measuring HRQoL and symptoms should be mandated across all studies to enable comparability, with organ- or transplant-specific PROMs added as needed.

If PROMs are systematically incorporated into both clinical care and research, they can provide important insights in PROs at both the population and patient levels.

At the population level, pooled PROM data can be integrated into meta-analyses to evaluate treatment effects, compare outcomes across patient groups or with healthy individuals, and inform evidence-based treatment guidelines. Structured, longitudinal collection of individual PROM results yields insights into trajectories of symptoms and HRQoL over time, and can further strengthen our understanding of their impact on outcomes such as mortality.^18,51-53

At the patient level, PROMs provide a more comprehensive understanding of life after transplantation, support shared decision-making, and enable tailored interventions. For example, patients with CKD often prioritize quality of life over longevity,⁹⁸ whereas kidney transplant recipients generally value graft survival above life expectancy—suggesting a higher tolerance for immunosuppression than clinicians typically recommend.⁹⁹ As symptom experiences vary by gender and age,¹⁹ PROMs capturing immunosuppression-related side effects, symptoms, and HRQoL can guide regimen selection for individual patients.

CONCLUSIONS

Despite growing recognition of the value of PROMs in SOT research and clinical care, their use is currently low, inconsistent, and heterogeneous. Without systematic efforts, PROMs remain fragmented and underutilized, despite clear calls from patients, clinicians and regulators to integrate the patient voice into transplantation research and care. The routine collection of standardized PROMs holds great potential to improve both research quality and patient outcomes. The next step is coordinated, large-scale implementation, ensuring that PROMs become an integral part of SOT research and clinical care.