Points of View Benefits and Challenges of Patient-Reported Outcome Measure (PROM) Interventions from a Systematic Review
Benefits and Challenges of Patient-Reported Outcome Measure (PROM) Interventions Based on Systematic Reviews

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Shinji Tsubakihara, Senior Researcher, Pharmaceutical and Industrial Policy Research Institute
Takahiro Shiraishi, Senior Researcher, Pharmaceutical and Industrial Policy Research Institute
Kyumi Yoshino, Senior Researcher, Pharmaceutical and Industrial Policy Research Institute

SUMMARY

1. Introduction

Patient-Reported Outcome (PRO)" is now considered an important element for promoting patient participation in healthcare in industry, government, and academia. (Patient-Reported Outcome Measure, or PROM) used in clinical trials based on the FDA's published ^data1 ) and an analysis of the number of clinical trials introducing PROs in major ^countries2). From these analyses, we found that PROs are being incorporated into clinical trial endpoints as part of Clinical Outcome Assess-ment (COA) to evaluate changes in patient symptoms and experiences with (new) drug interventions, and that patient experiences are being used in drug development in an increasing number of cases. The number of cases in which PROs are incorporated into clinical trial endpoints and patient experiences are used in drug development is on the rise. For more information on PROs, please refer to News No. 75.

Meta-analyses of cancer clinical trials have continuously reported that self-rated values of health-related quality of life (HRQoL) by specific PROMs are statistically correlated with patient mortality outcomes and are useful in predicting ^{outcomes3, 4, 5)}. Specifically, retrospective analyses have shown that the use of the EORTC QLQ-C30, a cancer disease-specific PROM, is highly likely to contribute to the prediction of mortality events and behavior in response to event-related symptoms (such as pain and anorexia) in cancer patients.

In contrast, whether the act of asking patients to report their own status using PROMs is in itself beneficial remains controversial. Although there are many clinical studies that have prospectively evaluated PROM self-assessment behavioral interventions for patients, the conclusions regarding the value and effectiveness of the interventions vary when looking at individual studies.

In this article, we selected articles appropriate to the topic of this paper from systematic reviews and meta-analyses of PROM intervention clinical studies and clinical trials obtained through a literature search in 2020 and beyond, and three members of the Policy Research Institute's "Value Evaluation Team" agreed to outline five articles. The paper also introduces the advantages and challenges of implementing PROMs in real clinical practice, clinical research, and clinical trials. According to the FDA's "Guidance for IndustryPatient-Reported Outcome Measures" (2009), PROs are measures of patient-reported outcomes such as symptoms and quality of life. According to the FDA's "Guidance for IndustryPatient-Reported Outcome Measures" (2009), PROs are health outcomes directly reported by patients, such as symptoms and quality of life, and PROMs are tools such as scales and questionnaires used to evaluate and measure these PROs. In the original paper, the terms "PROs" and "PROMs" are used in the plural, but in this paper, they are used in the singular.

2. Summary of the systematic review

(1)-(4) provide an overview of four systematic reviews of PROM intervention clinical studies. Two of the reviews are qualitative and two are quantitative evaluations of the effects of PROM interventions across diseases, and two are meta-analyses that evaluate the effects of PROM interventions on various outcomes in cancer patients and on events such as death. Each review is unique, but interpretation needs to be considered because of differences in target diseases, analysis objectives, outcomes covered, and analysis methods. Finally, an overview of one systematic review of pediatric oncology clinical research (5) is presented.

⁽ 1) Campbell R.et al.

This is a systematic review of clinical studies that evaluated the experience of PROM use in actual clinical practice from a qualitative (qualitative) perspective. The rationale for limiting the review to qualitative studies was to explore the perspectives and perceptions of both patients and providers of PROMs in order to identify the benefits and limitations of PROM use in clinical practice. This review is based on the internationally used "the PreferredReporting Items for Systematic Reviews and Meta-Analyses (PRISMA) The quality of each article was assessed according to the 2009 edition of the "PreferredReporting Items for Systematic Reviews and Meta-Analyses (PRISMA)" and the guidelines of the "Centre for Reviews and Dissemination (CRD)" in the UK. The quality of each article was independently assessed by two reviewers using the Consolidated Criteria for Reporting Qualitative research (COREQ) checklist. Two reviewers independently evaluated each paper using "the Consolidated Criteria for Reporting Qualitative research (COREQ) checklist" and discussed and reached a conclusion until a consensus was reached on the scoring results.

Of the 2,388 articles selected from various literature databases using the defined search criteria through May 2021, 52 articles on 50 PROM intervention clinical studies ultimately met the criteria for the purpose of this review. The number of studies in terms of facility or care studied was 22 in primary care, 9 in hospitals, 9 in outpatient clinics, 4 in palliative care, 5 in multiple settings, and 1 in other; when categorizing studies from the perspective of assessing the value/effectiveness of PROM interventions, 26 were from the provider perspective, 7 from the patient perspective, and 17 from both. The means of PROM collection was 26 electronically reported PROMs ("ePRO"), 12 paper-described PROMs, 4 two-party studies, and 8 no type descriptions. These studies used a variety of PROMs with diverse patient groups as controls, including cancer, diabetes, and cardiovascular disease.

The review identified the following five key benefits of PROM implementation: (1) active patient engagement and partnership with patients, (2) improved accuracy of consultation focus, (3) improved quality of medical care, (4) standardization of patient outcome monitoring, and (5) enhanced patient-provider relationships (Table 1). (Table 1). The specific benefits of each were described as (1) enabling both patients and healthcare providers to further recognize the current situation and to think carefully about it, (2) promoting patient participation in treatment, and (3) facilitating the setting of treatment goals between patients and healthcare providers. In (2), PROMs can be used as a tool to assist in disease screening and facilitate prioritization of patient needs; (3) can be used as a diagnostic aid; they are useful in realizing personalized care; they ensure the practice of holistic care; they can connect healthcare providers to the responses necessary for patients; (4) can be used to determine treatment efficacy and side effects; and (5) can be used as a tool to identify symptoms. (4) can be used to determine treatment effects and side effects, and to monitor changes in symptoms and disease progression; and (5) can be used to reassure patients about the care provided by healthcare providers, and PROMs can show interest in patients and strengthen relationships with them.

At the same time, the following limitations of the PROM effect were noted. (1) PROMs may not provide honest answers (for example, when diagnosing depression, patients may not want to be treated), (2) PROMs may lead to unimportant claims, which may force the clinician to deal with low priority issues, and (3) PROMs may only reflect part of the patient's overall picture. (3) inaccuracy due to insufficient information, speculative recognition of patients' problems, patients themselves not being aware of the use of PROMs in decision making, and excessive expectations of medical staff by patients. (5) concerns that PROMs are not formal enough to build a close relationship, and (6) concerns about the lack of conversation with doctors. Other opinions included the opinion that PROM evaluations are not specific enough to show clinical meaning, concerns about giving patients unnecessary information, and the opinion that PROMs are not suitable for all patients, such as the elderly.

While the study demonstrated the advantages of PROMs in clinical practice from the perspectives of both patients and clinicians, it also pointed out some limitations, and the authors suggest that further research is needed to address these limitations if PROMs are to be recognized and widely used as a means of improving patient outcomes in clinical practice.

⁽ 2) Bonsel J.M.et al.

PROM data are used not only for the health of individual patients, but also for policy-level decision making by providing information feedback to health care providers, insurers, and policy makers to understand and improve the level of medical technology provided by health care institutions and to identify and fill shortfalls in health care resources. This systematic review identifies recent applications of PROM data from clinical studies of PROM interventions conducted at the micro-level (individual patients), meso-level (patient groups), and macro-level (community and society). The purpose of this study is to identify recent applications of PROM data from clinical studies of PROM interventions conducted from a societal (regional) perspective. The "function" here refers to the mechanism by which a PROM intervention affects a given patient outcome.

The reviews were selected according to the PRISMA guidelines (2020 edition), and two reviewers were independently selected using "the Effective Public Healthcare Panacea Project's Quality Assessment Tool for Quantitative Studies. A score was assigned to each assessment domain, and a three-point scale (0, 1, or 2 or higher, with lower scores indicating higher quality) was used for the overall assessment, depending on the number of weak points. The results of screening of 11,121 papers were selected using the search criteria defined by August 2023 using multiple databases and excluding duplicates. 159 papers were selected as applicable, and 57 papers were extracted by selecting papers with or without comparison groups and other criteria. Twenty-one new papers were added based on the tracking of cited papers, and finally, 76 clinical studies and 78 papers met the criteria.

Because of the diversity of results described, we present here the analysis of micro-level (individual patient) studies, which had the largest number of studies (Table 2). Patient outcomes varied from study to study, ranging from events such as "death" and "reduction in emergency room visits and readmissions" to "improvement in physical, mental, and social functioning," "improvement in depressive symptoms and cancer-related symptoms," and "experience with appropriate medical care" in the studies of cancer patients, for example. The first is that "patient outcomes" were defined as "improvement in physical, mental, and social functioning. First, the functions of PROMs that accounted for more than half of the studies with "improved patient outcomes" were "data feedback to healthcare providers (9/18)," "symptom screening (10/14)," and "symptom monitoring (18/25). A small number also did not provide feedback to patients. A small number of PROMs did not provide feedback to patients but did improve outcomes (3/3), and a high percentage of PROMs were effective in supporting patient decision-making (3/3).

The most common type of PROM used was "disease-specific measures" (55 studies), with about 70% of the studies reporting improved outcomes with PROM interventions. In contrast, four studies used "generic health rating scales" such as the EQ-5D alone, and only one study found improvement in outcomes. Nine studies combined disease-specific and generic scales, and 44% of the studies found improvement, a higher percentage than for generic scales alone. By disease area, "malignancies," "primary care," "orthopedics/trauma," and "gastrointestinal diseases" were the most common disease areas, in that order, suggesting that PROM interventions were relatively effective in improving outcomes in these areas, which have a high affinity for PROMs (Table 3). In addition, feedback of PROM data to healthcare providers is particularly effective in improving outcomes in cases in which it alerts providers to abnormalities in patients and leads to optimal responses.

The authors noted the following reasons why clinical studies of PROM interventions have not been successful. First, the authors noted that interventions using the Generic Health Rating Scale alone do not provide sufficient insight or information for health care providers to make therapeutic responses or treatment changes. Second, they note that PROM interventions tend to have a pronounced impact on outcomes such as improved general health perceptions and improved symptom burden, but not as strong an impact on event outcomes such as improved quality of life and prolonged survival. Other reasons inferred for this include patients' reluctance to discuss symptoms with their providers, providers' lack of sufficient time to continue, and providers' lack of knowledge about PROMs, which prevents them from implementing them.

Finally, the authors note that the quality of clinical studies demonstrating the effectiveness of PROM interventions is not yet sufficient, and further refinement and standardization of definitions of control treatments and intervention methods is needed. However, while there are many challenges to implementing PROMs in daily practice, several previous studies have described the value of PROMs in helping patients become more aware of their condition and potentially empowering them to actively participate in their own treatment. The results of the review also showed that PROMs provide important information and insight to health care providers about patient outcomes and increase their effectiveness in leading to appropriate medical care, making PROMs an important part of modern health care.

(3) Graupner C.et al ^.

While the previous review (2) showed that many PROM intervention trials have been conducted in patients with malignancies, what is presented here is a review dedicated to clinical studies examining the effects of PROM interventions in cancer care. This review includes studies comparing PROM intervention and non-intervention groups of cancer patients, as well as studies comparing PROM intervention studies with and without feedback to patients and/or providers. The review was conducted according to the PRISMA (2009 edition) guidelines. 8,341 reports and 8 additional reports were screened by 3 investigators, retrieved from multiple databases with defined conditions from 1998 to 2018, and 22 research articles were included in the review.

Of the 22 PROM intervention clinical studies with various outcomes, the results of the review of 15 studies that controlled for the PROM nonintervention group showed that the PROM intervention was reported to be beneficial in each outcome item (Table 4). Significantly improved" was defined as a significant improvement in all or some of the set outcomes in the intervention group relative to the nonintervention group; "trend toward improvement" was defined as an improvement in outcomes better in the intervention group than in the nonintervention group, although this was not explained by statistical analysis; "trend toward improvement (n.s.)" was defined as better in the intervention group, although not significantly different; "n.s." was defined as no significant difference ( not significant. Fourteen of the studies provided feedback of PROM data to patients and/or providers. Of these, 5 studies evaluated the impact on symptoms, 1 study found a significant improvement in the group with feedback, and 2 studies evaluated patient satisfaction, 1 study found a significant increase in the group with feedback. The two studies that evaluated patient satisfaction showed a significant increase in one study. Of the six studies that evaluated the relationship between patients and their health care providers (health care institutions), five studies described improvement in the with-feedback group, regardless of statistical significance.

The authors noted that while the PROM intervention studies in cancer patients were challenged by the fact that they often lacked power, feedback is strongly recommended, as more positive effects were observed when PROM data were fed back to patients and/or health care providers.

(4）Balitsky A.K.et al.(2024) ^9）

An updated systematic review and meta-analysis of PROM intervention randomized clinical trials in patients with solid tumors and hematologic tumors undergoing cancer treatment was reported in 2024. The review was conducted according to the PRISMA (2020 edition) guidelines: 9,662 articles were extracted from a search using multiple databases and definition criteria for the period 2012-2022, and 8 reviewers were paired and independently screened and scrutinized with the addition of 1 cited article After pairwise independent screening and vetting, 45 research papers were accepted, including the adjudicator. Of these, 27 studies included patients receiving chemotherapy. The quality of evidence for each outcome meta-analysis was assessed according to the international standard "Grading of Recommendations Assessment, Development and Evaluation (GRADE). GRADE.

Clinical studies examining event rates were selected for this meta-analysis, including Basch E. et al.'s (2016,2017) randomized clinical ^{study10, 11) that} evaluated the effect of ePRO intervention on prolonging cancer patients' lives, which was also accepted for review (2) and (3). This study found that 766 patients with four types of cancer undergoing chemotherapy were randomly assigned to two groups with or without ePRO intervention, and after a median follow-up of approximately 7 years, a significant survival benefit was observed in the intervention group (Figure 1). In addition to this, three studies evaluating the impact of the PROM intervention on survival were included in the meta-analysis. The analysis found a small but significant survival benefit with PROM intervention (Hazard Ratio 0.84, 95% CI 0.72-0.98, GRADE: Moderate), suggesting that the use of PROMs in cancer patients may prolong life (Figure 2). It can be inferred that this contributory effect is largely influenced by the results of the Basch et al. study, in which the largest number of patients was tested and a significant survival benefit was observed. In addition, a meta-analysis of the impact of PROM interventions on HRQoL showed a significant improvement in quality of life at the 12-week assessment in the EORTC QLQ-C30 cancer-specific disease scale intervention study (weighted mean difference 2.45, 95% CI 0.42-4. 48,GRADE: Moderate). However, no significant improvement was observed at the 24- and 48-week assessments of the QLQ-C30 intervention (Figure 3, GRADE: Low, Very Low) and at the 24-week assessment of the EQ-5D intervention, a generic rating scale (no figure, GRADE: Very Low). In addition, a meta-analysis of emergency facility transport and hospitalization events did not identify a significant event reduction effect of the PROM intervention (no figure, GRADE: Low for both).

This review suggests that PROMs are effective in prolonging survival and improving quality of life, and that PROM collection may help providers better understand patients' changing symptoms and needs, and may help avoid poor patient outcomes by addressing problems earlier. On the other hand, while previous studies have shown that the act of writing PROMs makes patients more aware of their symptoms and more willing to discuss their symptoms with their health care providers, oncologists are more familiar with managing physical symptoms but less familiar with addressing issues related to quality of life and mental health. This indicates a challenge in introducing PROMs into the routine care of cancer patients. However, the review states that various studies of PROM interventions have shown evidence of patient benefit, and that the introduction of PROMs into cancer care is important, and that further research is needed to incorporate PROMs into routine care, as they provide a standardized, high-quality outcome measure.

(5) Rothmund M.et al. (2022) ¹² )

This review is a systematic review of supportive care intervention trials for pediatric cancer patients. Although not strictly a review of PROM intervention trials, we believe that patient quality of life is an important measure in supportive interventions to alleviate symptoms and distress, and we have chosen to include it in this article to gain a better understanding of the current use of PROMs in the pediatric setting.

From 4,789 studies retrieved by definition criteria from European and U.S. clinical trial databases from supportive intervention clinical trials for pediatric cancer patients initiated after January 2007, 229 studies were eligible for inclusion after three reviewers assessed eligibility. This review was said to be compliant with the PRISMA (2015 edition) guidelines. Medical interventions were categorized as "drugs" (systemic or local administration) and "procedures" (including pain relief, radiation, ultrasound, and surgical); behavioral interventions were categorized as "educational, psychological, and social" and "physical" (exercise, etc.); interventions not included above, such as diet, were analyzed as "other.

Table 5 shows a breakdown of the number of supportive intervention trials for 229 pediatric cancer patients and an excerpt of the percentage of PROM use (items with differences). The percentage of PROM use between groups was statistically analyzed with a ^χ2test (95% confidence interval), and Ф/V indicates effect size. Geographic analysis showed 49% in North America, 20% in Europe, 7% in Asia, and 6% in international studies, of which 49% in North America, 56% in Europe, 35% in Asia, and 21% in international studies used some form of PROM ( p = 0.053). Single-center trials accounted for 63% and multicenter international collaborations for 11%, with the former 47% using PROMs versus 21% in the latter ( p = 0.032). Academia-initiated trials accounted for 88%, and the remainder were industry-initiated trials. There was a significant difference in the percentage of PROMs used in academia-led trials (48%) versus company-led trials (19%) ( p = 0.004).

In terms of tumor type, trials involving both solid and hematologic tumors accounted for about half of the trials (48%), with 55% using PROMs ( p = 0.004). By intervention type, "drugs" was the most common (47%), followed by "procedures" (6%), "physical" behavioral interventions (18%), and "educational, psychological, and social" behavioral interventions (21%); PROM use was significantly skewed by intervention type with 22%, 29%, 68%, and 79%, respectively ( p < 0. 001). 001) (Table 5, Figure 4). Multivariate analysis using binomial logistic regression predicted the likelihood of PROMs being introduced into pediatric cancer supportive care trials in each group, with blood cancer alone and drug intervention trials significantly less likely to introduce them (both p < 0.05, no table).

Based on the review results, the authors concluded that the following problems with supportive intervention trials for pediatric cancer patients were identified: 1) the proportion of PROM use was significantly low, despite the fact that the majority of the purpose of supportive care should be to improve quality of life, 2) although the number of trials has increased over time, the proportion of PROM introduction has changed little, 3) despite the fact that drug intervention trials account for the majority of trials, the proportion of PROM introduction was significantly lower than that of drug intervention trials. (3) The rate of PROM use was extremely low despite the fact that many trials involved drug intervention.

The study also noted that although previous studies have shown that children and adolescents require multidimensional assessment, including psychological distress as well as physical distress, the currently available PROMs for pediatric cancer patients are insufficient for psychological assessment, and pediatric PRO research is lagging behind. It is necessary for health care providers and caregivers, such as parents, to assess the condition of pediatric patients according to age and cognitive ability to supplement information (clinician-reported outcome, observer-reported outcome). However, proxy-reporting alone does not provide sufficient information on the psychological burden of pediatric patients and may underestimate quality of life, and since PROs are the only means of gaining in-depth knowledge of information related to the subjective experiences of pediatric patients that is not available to others, the introduction of PROMs into supportive intervention trials should be the standard, without exception. It should be the standard, according to the report.

3. Summary and Discussion

A systematic review/meta-analysis of four PROM intervention clinical studies and one systematic review of PROM use in pediatric cancer clinical studies are outlined. In general, qualitative and quantitative analyses of clinical studies indicate that PROM interventions in practice are useful in improving patient outcomes. In detail, the review found that "PROMs encourage patients to actively participate in their treatment, and that active discussions with health care providers lead to improved awareness of their own health," that "understanding patient needs through PROMs leads to improved quality of care, including more appropriate and prompt medical responses," that "PROM interventions may contribute to prolonged patient survival and improved health-related quality of life," and that "PROMs may contribute to improved health-related quality of life. PROM interventions may contribute to prolonging patient survival and improving health-related quality of life," "feedback of PROM data to patients and providers is useful for improving various patient outcomes," and "PROM interventions are suggested to be more useful for improving outcomes on disease-specific measures than on generic measures. While clinical studies in various disease ^{areas13, 14, 15)} have reported statistical correlations between scores on disease-specific and generic rating scales, the two reviews did not show statistical differences, but did show that disease-specific rating scales compared to generic rating scales, such as the EQ-5D, may be useful in improving patient outcomes A number of challenges to PROM collection have been noted. Individuals have expressed skepticism about the reliability of PROMs, ^{such as} "PROM data are not clinically meaningful," "PROM data contain inaccuracies due to over- or under-information," "PROMs do not provide honest responses from patients, " ⁶⁾ and "PROM interventions worsen health-related quality of life in patients. A review of PROM collection in cancer ^care16) found that "the burden on healthcare providers (workload, time, technology, and responsibility) incurred in the collection and utilization of PROM data in routine care," "inadequate (ePRO) infrastructure at healthcare institutions," "patients' lack of understanding of PROMs," "patients' unfamiliarity with ePRO input operations" and other issues. In addition to the lack of infrastructure, the author of citation 9 cites "insufficient incentives for healthcare providers to collect and utilize PROM data. ^"17) The challenges of PROM intervention studies include "high risk of bias and insufficient power of detection, " ⁸⁾ "collection methods, measurement methods, outcome setting, timing of implementation, ^{9, 16)}, etc., and there are numerous hurdles to standardizing the implementation of PROMs into routine clinical practice. In addition, a review of pediatric oncology clinical trials indicated that the use of PROMs is significantly low in company-initiated trials and drug intervention trials, a point that the pharmaceutical industry should reflect on.

The development of technology to collect and structure the "candid" voices of patients in the exam room and in their daily lives is an important element in resolving these issues. Currently, a voice AI tool is being developed that can record conversations with patients and classify patient information in "SOAP" (S: subjective information, O: objective information, A: evaluation, P: planning) categories to create medical ^records18). Physicians at facilities that have actually implemented these tools in daily medical care say that they have improved the efficiency of medical care not only in charting, but also in patient support and information sharing. In addition, natural language processing AI is being developed to assist in the diagnosis of dementia risk based on conversations between doctors and patients, limited to ^diseases19).

If these technologies advance in the near future, they will free the patient side from the conventional problem of immaturity of ePRO tablet operation skills by children and the elderly. As for the standardization of PROMs, which is an issue for medical providers, it will be possible to standardize data collection methods using PROMs with AI voice or AI guidance, and as for the lack of trust in PROM data, the possibility of obtaining honest answers from patients will be increased by asking them questions in a conversational style. As a result, the amount of data obtained from the patient's voice will be vastly increased. As a result, the vast amount of natural language unstructured data obtained from patients' voices will be structured by AI and can be used for comparison among medical technologies, which will be one of the important indicators for improving outcomes for the development of new medical technologies.

Considering the value of PROMs at the micro level (individual), the importance of "shared ^{decision-making20)} (hereafter SDM): shared decision making" has been increasing recently as one of the initiatives for "patient-centered" healthcare. shared is often described as joint or collaborative. It is a consensus-building process in which patients and providers mutually understand what is important to them and what should be done, and decide on a treatment plan through discussion, while satisfying the needs of patients to make their own choices about their own treatment, so that patients do not feel anxious or frustrated by the asymmetry of information between providers and patients. There are reports that patient-reported SDM is associated with increased treatment ^{satisfaction21)} and that SDM has resulted in decreased conflict over treatment ^decisions22). In such situations, PROMs that "accurately" reveal the patient's condition can be utilized for mutual understanding of the current situation between the patient and the healthcare provider, and we believe that PROMs can contribute to SDM as an important tool.

When viewed at the macro level (society), global trends indicate that many OECD member countries are currently scaling up the scope of PROMs to be collected or expanding the target diseases for which PROMs are collected, and it is reported that governments, hospitals, and universities are the most common entities implementing PROM programs, in that ^order23). Many of these countries use PROM data, the "voice of the patient" collected by government and academia, as an indicator to evaluate and improve the "quality" of the medical care provided. In medical technology development, efficacy and safety evaluations obtained from clinical trials conducted by companies remain the most important evidence. However, it is expected that many innovative medical innovations will be produced in the future. In Japan, it is important that industry, government, and academia cooperate to establish a system for continuous and "accurate" evaluation of the value of new medical technologies provided to patients, including appropriate PROM data as well as medical information obtained after the product is launched.

If the concept of patient participation in medical care becomes widespread in daily medical care and clinical research, and if it becomes common practice to collect patient opinions in the real world, the understanding of "wellbeing" sought by individual patients will deepen, and the significance of SDM will increase, which may lead to improvement of the quality of medical care. At the same time, the constant use of highly accurate and standardized health-related quality of life measurement tools in medical care and clinical trials according to diseases and symptoms will create an environment that will enable further innovation and accurate evaluation of medical technologies. This is true not only for efficacy and safety, but also for economic evaluation.

4. Conclusion

In recent years, ePRO infrastructure development research and ePRO intervention research have been conducted in cancer patients and HIV patients by domestic ^{academia24,25)}, and much more discussion and research is needed to realize the aforementioned environment. Industry, government, and academia should understand the value of PROs and cooperate to promote the understanding of the value of collecting the patient's voice in society, and eventually, policies to implement disease-specific and highly accurate PROMs for each patient segment, such as children and the elderly, in the clinic, development policies to enhance the functionality of PROMs, policies to promote the algorithmization of PROM data, and policies to promote the use of PROM data. We expect that policies to promote the implementation of disease-specific and accurate PROMs for each patient segment (e.g., children, elderly, etc.), policies to promote the development of advanced PROM functions, and policies to link PROM data to various health and medical information will be promoted in an integrated manner.

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