Application Of Patient-reported Outcomes Research Articles

An application (ePRO) -based patient reported outcomes of quality of life from an innovative cancer care delivery model.

e23176 Background: With the accessibility of smartphones, it has become possible to develop applications for patient-reported outcomes. Quality of life (QoL) is an important measure in oncology research. We developed a phone application that could use any standardized form to be filled in by the patient. Here, we report using the EORTC questionnaire, QLQ-C30, built into the application as a form for data collection from our ongoing district cancer care program, which offers support at government district hospitals in India using an alternate oncology work force. Methods: An application (ePRO) was created, which allows one doctor administrator to follow the patients. Once the application is downloaded, the patient opens the QoL questionnaire (QLQ-C30), built into the application, and completes it using a smartphone. The researcher downloaded the data in Excel format and analyzed it. The application was attempted at a tertiary cancer center and a public hospital district cancer unit. A cross-sectional study was conducted over six months in 2023.The data were analyzed using SPSS version 24. Results: The application was downloaded and activated on the smartphones of 441 patients. Patients completed the form available through the application. Of all the respondents, 229 (51.9%) were male and 212 (48.1%) were female. The mean QoL of the tertiary hospital was 69.29, with a standard deviation (SD) of 18.98.The QoL scores were 50.94 (SD 23.50) in district hospital 1 and 77.01 (SD 17.35) in district hospital 2. The difference between one district and the other was significant (p < 0.001). The symptom scale scores varied between district hospitals and other hospitals. Conclusions: This presentation serves two purposes: to validate a new patient-reported outcome application and to provide data on QoL from peripheral centers compared with tertiary centers. The use of technology is feasible and can help gather patient-reported outcomes easily. There appears to be a difference in the quality of life of patients from different geographical locations. [Table: see text]

A Mobile Health Application Integrated in the Electronic Health Record for Rheumatoid Arthritis Patient-Reported Outcomes: A Controlled Interrupted Time-Series Analysis of Impact on Visit Efficiency.

Patient-reported outcome (PRO) collection between visits for rheumatoid arthritis (RA) could improve visit efficiency, reducing in-person visits for patients with stable symptoms while facilitating access for those with symptoms. We examined whether a mobile health PRO application integrated in the electronic health record (EHR) could reduce visit volume for those with RA. We developed an application for RA that prompted patients every other day to complete brief PRO questionnaires. Results of the application were integrated into the EHR. We tested the application in a controlled interrupted time-series analysis between 2020 and 2023. Rheumatologists received EHR-based messages based on PRO results recommending the patient receive a visit earlier or later than scheduled. The primary outcome was monthly visit volume during the year before versus the year after initiation. A total of 150 patients with RA consented and used the application. The median age was 62 years, 83% were female, 7% had fewer than 2 years of disease, and 50% were seropositive; 150 controls were well matched. Among those in the application cohort, the estimated monthly median visit volume in the year before use of the application was 31.2 (95% confidence interval [95% CI] 28.0-34.3); in controls, this was 30.4 (95% CI 27.3-33.6). In the year using the application, the estimated monthly visit volume was 36.8 (95% CI 33.4-40.3) compared to 38.7 (95% CI 35.2-42.3) in controls. The difference in the differences between the cohorts was not statistically significant (-2.7 visits, 95% CI -9.3 to 4.0). No differences were noted in flare rates or visit delays. In this initial trial of a PRO application intervention to improve visit efficiency, we found no association with reduced visit volume.

The global patient-reported outcomes for multiple sclerosis initiative: bridging the gap between clinical research and care - updates at the 2023 plenary event.

Significant advancements have been achieved in delineating the progress of the Global PROMS (PROMS) Initiative. The PROMS Initiative, a collaborative endeavor by the European Charcot Foundation and the Multiple Sclerosis International Federation, strives to amplify the influence of patient input on MS care and establish a cohesive perspective on Patient-Reported Outcomes (PROs) for diverse stakeholders. This initiative has established an expansive, participatory governance framework launching four dedicated working groups that have made substantive contributions to research, clinical management, eHealth, and healthcare system reform. The initiative prioritizes the global integration of patient (For the purposes of the Global PROMS Initiative, the term "patient" refers to the people with the disease (aka People with Multiple Sclerosis - pwMS): any individual with lived experience of the disease. People affected by the disease/Multiple Sclerosis: any individual or group that is affected by the disease: E.g., family members, caregivers will be also engaged as the other stakeholders in the initiative). insights into the management of MS care. It merges subjective PROs with objective clinical metrics, thereby addressing the complex variability of disease presentation and progression. Following the completion of its second phase, the initiative aims to help increasing the uptake of eHealth tools and passive PROs within research and clinical settings, affirming its unwavering dedication to the progressive refinement of MS care. Looking forward, the initiative is poised to continue enhancing global surveys, rethinking to the relevant statistical approaches in clinical trials, and cultivating a unified stance among 'industry', regulatory bodies and health policy making regarding the application of PROs in MS healthcare strategies.

Application of Patient-Reported Outcomes in Back Pain in Adults: Part 2

The aim of the research is generalization of information about the most common foreign and domestic scales and questionnaires used in acute and chronic back pain (BP). The analysis of Russian-language and foreign literature was carried out with a search depth of 5 years (2016–2021) in the following databases: e-Library, PubMed, Oxford Press, Clinical Keys, Springer, Elsevier, Google Scholar. To diagnose back pain and assess the characteristics of its course in dynamics, both a standardized study is used: collection of complaints, anamnesis, objective examination, assessment of neurological status, as well as valid PRO. For timely diagnosis and monitoring of the development of BP in patients with osteochondrosis of the spine, a wide range of scales and questionnaires were proposed, which we ranged into 4 groups: scales for assessing the quality of life of patients with BP; scales for assessing the characteristics of pain in BP; scales for assessing disease outcomes in BP; scales for assessing disability in BP. The second part of the thematic review presents an analysis of the advantages and disadvantages of scales for assessing pain characteristics, disease outcome and disability in patients with BP. Patient-reported outcomes assessment tools for patients with BP are popular in the world medical practice, however, it is necessary to adapt to the use in domestic clinical practice of such scales as Pain Quality Assessment Scale and Pain Quality Assessment Scale Revised (PQAS and PQAS-R), The Patient Assessment for Low Back Pain - Symptoms (PAL-S), Orebro Musculoskeletal Pain Questionnaire (OMPQ).

A cross-sectional study on the application of patient-reported outcome measurements in clinical trials of traditional Chinese medicine in mainland China.

Objectives: Patient-reported outcomes (PROs) provide a global perspective of patient health status which plays an enormous role in evaluating clinical efficacy. However, the application of PROs in traditional Chinese medicine (TCM) was still insufficiently studied in mainland China. Methods: This cross-sectional study was performed based on interventional clinical trials of TCM that were conducted in mainland China from 1 January 2010, to 15 July 2022. Data was retrieved from the ClinicalTrials.gov and Chinese Clinical Trial Registry. We included interventional clinical trials of TCM for which the country of the primary sponsors or recruitment settings in mainland China. For each included trial, data including clinical trial phases, study settings, participant's age, sex, diseases, and the patient-reported outcome measures (PROMs) were extracted. Trials were categorized into four categories according to 1) listed PROs as primary endpoints, 2) listed PROs as secondary endpoints, 3) listed PROs as coprimary outcomes (both primary and secondary endpoints), and 4) did not mention any PROMs. Results: Among a total of 3,797 trials, 680 (17.9%) trials listed PROs as primary endpoints, 692 (18.2%) trials listed PROs as secondary endpoints, and 760 (20.0%) trials listed PROs as coprimary endpoints. Among 675,787 participants included in the registered trials, 448,359 (66.3%) patients' data were scientifically collected by PRO instruments. Neurological diseases (11.8%), musculoskeletal symptoms (11.5%), mental health conditions (9.1%) were the most common conditions evaluated by PROMs. Disease-specific symptoms related concepts were used most frequently (51.3%), followed by health-related quality of life concepts. Visual analog scale, 36-item Short-Form Health Questionnaire, and TCM symptom score were the most common PROMs in these trials. Conclusion: In this cross-sectional study, the use of PROs increased in the past decades according to clinical trials of TCM conducted in mainland China. Considering that the application of PROs in clinical trials of TCM has some existing issues including uneven distribution and lack of normalized PROs of TCM, further study should be focused on the standardization and normalization of TCM-specific scales.

Analysis of patient-reported outcomes in the approval of novel oncology drugs in the United States, 2017–2022

With the growing notion of patient-focused drug development, the quality of life and other patient-reported outcomes (PROs) of cancer patients are gaining considerable attention. Several drug regulatory agencies, including the U.S. Food and Drug Administration (FDA), are calling attention to PROs. This review aims to comprehensively characterise the application of PROs and regulatory considerations for PROs in the FDA-approved novel oncology drugs. The FDA review documents and labels for novel oncology drugs approved from July 2017 to July 2022 were retrieved. We collected and analysed drug approval information, types of endpoints for PROs, PRO measures, designs of trials including PROs, and regulatory comments on PRO-related contents. Results demonstrated that PROs were used more commonly for solid tumours than hematologic malignancies, which might be correlated with the disease characteristics. We further categorised and analysed existing PRO measures, providing insight for tool selection in future oncology trial design. Our findings also indicated that PROs currently do not play a significant role in oncology drug approvals. The major deficiencies related to PROs commented on by FDA reviewers were analysed, followed by recommendations for improvements. This review demonstrates that PROs currently do not play a significant role in oncology drug marketing review, and how they can be used to support the approval of new oncology drugs is still in the exploratory stage. This current situation is not only related to the deficiencies in the design and implementation of PRO-related contents in oncology trials, but more importantly, it is a reminder that we should pay more attention to patient experience in the development of oncology drugs. This study was not supported by any funding.

Use of patient-reported outcomes in heart failure: from clinical trials to routine practice.

Heart failure (HF) is a complex syndrome that affects mortality/morbidity and acts at different levels in the patient's life, resulting in a drastic impairment in multiple aspects of daily activities (e.g. physical, mental/emotional, and social) and leading to a reduction in quality of life. The definition of disease status and symptom severity has been traditionally based on the physician assessment, while the patient's experience of disease has been long overlooked. The active participation of patients in their own care is necessary to better understand the perception of disease and the multiple aspects of life affected, and to improve adherence to treatments. Patient-reported outcomes (PROs) aim to switch traditional care to a more patient-centred approach. Although PROs demonstrated precision in the evaluation of disease status and have a good association with prognosis in several randomized controlled trials, their implementation into clinical practice is limited. This review discusses the modalities of use of PROs in HF, summarizes the most largely adopted PROs in HF care, and provides an overview on the application of PROs in trials and the potential for their transition to clinical practice. By discussing the advantages and the disadvantages of their use, the reasons limiting their application in daily clinical routine, and the strategies that may promote their implementation, this review aims to foster the systematic integration of the patient's standpoint in HF care.

Symptom Trajectories Informing Patient Care After Lung Cancer Surgery: A Longitudinal Patient-Reported Outcome Study.

Application of patient-reported outcomes (PROs) in surgical oncology has been limited because of patient heterogeneity. We analyzed symptom trajectories and their associations with recovery outcomes after lung cancer surgery, aiming to profile the heterogeneity of patients' experiences and to identify patients needing extensive care. Symptoms were assessed with the MDASI-LC before surgery, daily after surgery in hospital and weekly within 1 month after discharge. Patients were clustered based on symptoms from post-operative day 1 (POD1) to POD5, using the latent-class-trajectory-model. Functional recovery was compared across the trajectories. Logistic regression was used to explore risk factors for trajectories of more severe symptoms. Based on the five most severe post-surgery symptoms (pain, fatigue, coughing, shortness of breath, and disturbed sleep), we identified three distinct symptom trajectories among 424 patients [mild, N = 225 (53.07%); severe-to-mild, N = 86 (20.28%); severe, N = 104 (24.53%)]. At discharge, more 'severe' patients (73.96%) did not achieve a functional recovery compared with those in mild (32.54%, P < 0.0001) or severe-to-mild (56.96%, P = 0.0274) groups. Factors of significant symptom increase on POD1 were younger-than-55 (OR = 1.94 [95% CI 1.30-2.93], P = 0.001), undergoing open or multi-port video-assisted thoracoscopic surgery (OR = 1.59 [95% CI 1.05-2.41], P = 0.03), and using two chest tubes (OR = 1.72 [95% CI 1.12-2.65], P = 0.01). For patients experiencing dramatic symptom increase on POD1, older age (OR = 2.51 [95% CI 1.40-4.59], P = 0.002) was associated with 'severe' trajectory. This study demonstrated that PRO measures were capable of profiling heterogeneous symptom trajectories after lung cancer surgery. Those in-hospital trajectories were able to differentiate patients' responses to treatments and signal the needs for extensive post-discharge care.

Application of Patient-Reported Outcomes in Back Pain in Adults: Part 1

The aim of the research is generalization of information about the most common foreign and domestic scales and questionnaires used in acute and chronic back pain (BP). The analysis of Russian-language and foreign literature was carried out with a search depth of 5 years (2016–2021) in the following databases: e-Library, PubMed, Oxford Press, Clinical Keys, Springer, Elsevier, Google Scholar. For the diagnosis of acute and chronic BP and the assessment of the characteristics of its course in dynamics, both a standardized study may be use: collection of complaints, anamnesis, objective examination, assessment of neurological status, as well as valid scales and questionnaires. For the timely diagnosis and monitoring of the development of BP in patients, a wide range of scales and questionnaires were proposed, which were conventionally ranked into 4 groups: scales for assessing the quality of life of patients with BP; scales for assessing the characteristics of pain in BP; scales for assessing the outcomes of the disease in BP; scales for assessing disability in BP. The first part of the thematic review presents an analysis of the advantages and disadvantages of scales for assessing the quality of life of patients with BP. These perspective scales for assessing the quality of life of patients with BP are popular in the world neurological practice. It is necessary to adapt to the use in domestic clinical practice the Stratford Functional Back Pain Scale, the Index of Disability Associated with Pain, The Patient Assessment for Low Back Pain–Impacts.

Application of Patient-Reported Outcome Measurements in Clinical Trials in China

Regulatory authorities, industry peers, and international health policies have emphasized the value of assessing patient-reported outcomes (PROs) in clinical studies. Despite the increase in the number of clinical studies in the last decade in China, little is known about the extent of the use of PROs. To evaluate the application and characteristics of PRO instruments as primary and secondary outcomes in randomized clinical trials in China. A cross-sectional study of interventional clinical trials conducted in China from January 1, 2010, to December 31, 2020, was performed. Data obtained from the Chinese Clinical Trial Registry and ClinicalTrials.gov databases were evaluated. Trials were categorized according to those that (1) precisely listed PRO tools as outcomes, (2) mentioned patient subjective feelings in outcomes but did not clarify which tools were used for assessment, and (3) did not mention any PRO measurements. Data on study phase, setting, participant age, and sex were extracted from trials that considered patient feelings, along with the target diseases and names of the PRO tools. Among a total of 34 033 trials, 6915 (20.3%) listed the explicit PRO instruments used and 3178 (9.3%) included PRO in their outcomes but did not include the names of the assessment tools. From more than 32 million people included in the registered trials, data on 1.5 million (4.7%) patients were scientifically collected by PRO instruments, and subjective feelings were assessed for 693 867 (2.1%) participants. Pain (16.8%), cancer (15.6%), and musculoskeletal symptoms (13.3%) were the most common conditions for which PROs were precisely collected by tools. The most common tools for PRO measurements were the visual analog scale, Short-Form 36, and Hamilton Depression Scale. In this cross-sectional study, the use of PROs increased during the study period in clinical trials conducted in China. However, patient opinion appears to still be rarely measured. The application of PRO is geographically unevenly distributed. Development of PRO instruments, especially those suitable for the Chinese population, may be useful. Further expansion of PROs with respect to the scope of diseases is needed to avoid missing important data.

Abstract 2559: An analysis of patient-reported outcomes of radiation dermatitis in a multiracial/ethnic breast cancer population

Abstract More than half of cancer patients are treated with radiotherapy (RT), and many patients will develop acute radiation dermatitis (ARD) or skin reactions at some point during their treatment. In breast cancer, RT is a common adjuvant treatment and acute RT-induced dermatitis or skin reactions is a frequent side effect. Most acute RT-induced skin reactions resolve after several weeks, but some side effects persist and can cause serious complications. RD is reported by either the radiation oncologist or the patient and previous studies reported that there are disagreements between clinician-reported outcomes (CROs) and patient-reported outcomes (PROs). We have previously reported skin toxicity results using the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE). The current study focused on PROs of ARD symptoms that most frequently affect breast cancer patients and the degree that treatment impacted their normal daily activities. We evaluate the quality of life questionnaire administered on the last day of RT to 516 breast cancer patients receiving RT. Participants were asked to rate ARD-related symptoms on a 5-point Likert scale (0=Not bothered at all to 4=Very much). The symptoms measured were breast tenderness, pain, itching, warmth to touch, swelling, hyperpigmentation, blistering, thickening of the skin, hardness of breast, flaking, slow healing wounds, and erythema. Patients were also asked to rate the extent to which their treatment disrupted their normal daily activities on a 10-point Likert scale (0=Not all to 10=A lot). Hyperpigmentation was the most commonly reported symptom, with 25% of patients being highly bothered by the symptom. Erythema followed as the second most commonly reported symptom. Of the total 516 patients, 320 (77%) reported some form of disruption to their normal daily activities due to treatment. A number of the patient reported ARD-related symptoms differ by race/ethnicity, age, obesity, smoking history, and tumor stage. The results from a recent systematic review and meta-analysis, CROs and PROs of breast RD showed strong concordance. However, investigators concluded that clinicians reported significantly more acute edema, less acute breast pain, and less chronic breast shrinkage than patients. Considering the increasing combined application of CROs and PROs in clinical trials, our future research will highlight a critical issue regarding the accuracy of symptom reporting and subsequent management provided to patients. We will identify strategies to standardize items using a single tool to accurately and precisely estimate ARD from both the clinician and patient. Given the negative impact of ARD on patients' quality of life, further studies of ARD symptomology from both a patient and clinician standpoint are necessary to improve ARD management. Citation Format: Laura G. Acosta, Cristiane Takita, Jean L. Wright, Isildinha M. Reis, George R. Yang, Jennifer J. Hu. An analysis of patient-reported outcomes of radiation dermatitis in a multiracial/ethnic breast cancer population [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2021; 2021 Apr 10-15 and May 17-21. Philadelphia (PA): AACR; Cancer Res 2021;81(13_Suppl):Abstract nr 2559.

Patient-Reported Outcomes and Evidence-Based Practice in Speech-Language Pathology.

Purpose The patient's perspective of their health is a core component of evidence-based practice (EBP) and person-centered care. Patient-reported outcomes (PROs), captured with PRO measures (PROMs), are the main way of formally soliciting and measuring the patient's perspective. Currently, however, PROs play a relatively small role in mainstream speech-language pathology practice. The purpose of this article is to raise important questions about how PROs could be applied to EBP in speech-language pathology for individuals with communication disorders and to propose preliminary approaches to address some of these questions. Method Based on a narrative review of the literature, this article introduces relevant terminology and broadly describes PRO applications in other health care fields. The article also raises questions related to PRO-informed clinical practice in speech-language pathology. To address some of these questions, the article explores previous research to provide suggestions for clinical administration, interpretation, and future research. Conclusion More routine measurement of subjective health constructs via PROMs-for example, constructs such as effort, participation, self-efficacy, and psychosocial functioning-may improve EBP. More routine use of PROMs could significantly expand the information that is available to clinicians about individual clients and add to the evidence base for the profession of speech-language pathology. However, careful consideration and more research are needed on how to capture and interpret PROs from individuals with cognitive and language disorders.

A Paradigm Shift: Sharing Patient Reported Outcome via a National Infrastructure.

Digital solutions transform the way clinical services can be provided and make it possible for patients to participate in decisions concerning their own treatment. With the aim to support a better and more efficient healthcare system in Denmark, it has been agreed among authorities and care providers to establish a national infrastructure for sharing data between hospitals, municipalities, general practitioners and patients and concurrently develop standardized national digital cross-sector questionnaires for the purpose. Sharing data via the national infrastructure enables proactive involvement through patient reported outcomes (PRO). The national infrastructure forms a paradigm shift 1) for collaboration by moving from a baton-passing workflow to sharing-based workflow and 2) for the development of digital cross-sector questionnaires. Cross-sector questionnaire definitions are stored in a national questionnaire repository, and are used in local PRO applications to capture the patients' responses.

Are patient-reported outcomes useful in post-treatment follow-up care for women with early breast cancer? A scoping review.

Patient-reported outcomes (PROs) are frequently used to evaluate treatment effects and quality of life in clinical trials. The application of PROs in breast cancer clinics is evolving but their use to generate real-time information for use in follow-up care is uncommon. This proactive use might help to shift healthcare delivery toward a more patient-centered approach by acting as a screening tool for unmet needs or a dialogue tool to discuss issues proposed by the patient. This review aims to determine the effects and feasibility of using PROs proactively during follow-up care in early breast cancer. A systematic search was conducted in January 2019 in PubMed, Cochrane Library, Embase, and CINAHL. Studies that exclusively concerned women treated for early breast cancer where PROs were used as a proactive tool during follow-up were included. The search revealed a total of 653 records and four eligible studies were identified; three of which concerned the use of PROs both as a screening tool and as a dialogue tool, and one study in which PROs were used solely as a screening tool. The studies explored the feasibility of collecting and integrating PROs in the clinic and their ability to detect otherwise unrecognized problems. All of the included studies were prone to bias, but they point to potential benefits in respect of better symptom management in follow-up care. Our search identified a small number of low to moderate quality studies of the proactive use of PROs during follow-up after treatment for early stage breast cancer. The limited evidence available suggests that PROs may be useful for providing a more complete picture of the patient's symptoms and problems, possibly leading to improvements in symptom management.

PROeverywhere: Bridging the implementation gap of patient-reported outcomes with a mobile app.

203 Background: Patient reported outcome (PRO) data are critical for informing patient-centered care and have been shown to enhance our ability to communicate with patients, to control their symptoms, and to impact their survival. However, PRO data are not commonly collected in routine cancer care due to implementation challenges such as cost, technological rigidity of existing electronic health records, and misalignment of stakeholders’ incentives. Methods: In an effort to bridge the unmet needs of PRO collection and integration into routine cancer care, we aim to develop an effective, scalable, and sustainable symptom monitoring and management system that can be accessible worldwide. The system was developed using Xcode, the integrative development environment of Apple Inc., with the Swift programing language. Results: On Nov 28th, 2017, we launched a free, mobile PRO application on the Apple App Store – PROeverywhere. PROeverywhere is designed for reporting twelve common symptoms from the National Cancer Institute’s Common Terminology Criteria for Adverse Events. These symptoms include pain, fatigue, nausea/vomiting, appetite loss, diarrhea, constipation, shortness of breath, depression, anxiety, insomnia, memory problems, and neuropathy. Symptoms are reported in a 5-point scale – no symptom, mild, moderate, severe, and disabling. PROeverywhere has the functions to record symptoms, summarize the reporting in printout, and automatically store and analyze the input into graphical interpretations. Updates to PROeverywhere will be released in July 2018, with additional features that include longitudinal tracking dashboard, emoji scale, Spanish questionnaire, and “social networking” capability to connect users with potential to allow remote, real-time, reporting and monitoring. PROeverywhere is downloadable worldwide and securely powered by Google Firebase. Conclusions: PROeverywhere is developed to enable PRO data to be shared more easily and regularly in routine cancer care. Implementation of this free mobile application would allow for consistency in collection of PRO data with the potential to impact patient outcomes globally.

Use of Patient-Reported Outcome Measures in Quality Oncology Practice Initiative-Registered Practices: Results of a National Survey.

Measuring patient-reported outcomes (PROs) in clinical practice has been associated with improved survival and quality of life for patients with cancer. However, this application of PROs is relatively new, and little is known about how practices collect PROs, which PROs are measured, and what challenges are met in implementation. We surveyed Quality Oncology Practice Initiative-registered practices in December 2015 to understand the current state of PROs use and identify areas where implementation support may be needed. PRO collectors were asked to describe their views, practices, and challenges with implementation; noncollectors were asked about their interest in and perceived barriers to collection. Eighty-nine practices (38% of those that viewed the participation request) completed ≥ 50% of the survey and comprised the analytic sample. Most (79%) responders noted that collecting PROs was a high priority; slightly fewer actually collected PROs (69%). Most collectors (79%) were affiliated with hospitals or medical centers, and nearly all (94%) had electronic health records (EHRs). Collectors saw more patients per week than noncollectors ( P < .01). The PROs used by collectors addressed several topics, including patient distress (78%), symptoms (76%), and experience or satisfaction (70%). Perceived implementation challenges were similar for collectors and noncollectors: patient unwillingness to complete questionnaires and insufficient staff support; noncollectors additionally cited lack of PRO integration in the electronic health records. Widespread agreement that PRO collection is important has led to early adoption among a sizable minority of Quality Oncology Practice Initiative practices. Reaching consensus regarding which PROs are meaningful and developing and sharing best-practices that overcome implementation barriers could facilitate implementation and maximize PRO utility.

Patient-Reported Outcomes in Myelodysplastic Syndromes and MDS/MPN Overlap Syndromes: Stepping Onto the Stage with Changing Times.

Quality of life (QOL) and symptom burden are important measures captured by patient-reported outcomes (PROs). Myelodysplastic and myelodysplastic/myeloproliferative (MDS/MPN) neoplasm overlap syndromes are notable for significant morbidity and mortality, including a wide spectrum of physical and psychosocial effects. Thus, the development and application of PROs can provide meaningful information to facilitate communication and assist in follow up care. Disease-specific measures can more accurately reflect the full breadth of functional restrictions and symptoms. While traditional endpoints include remission, relapse, and survival rates, adoption of PROs in myeloid neoplasm clinical trials can facilitate drug approval. Integration of PROs in myeloid neoplasms is an important measure to capture QOL and symptoms, which can improve disease management.

Montreal Accord on Patient-Reported Outcomes (PROs) use series – Paper 4: patient-reported outcomes can inform clinical decision making in chronic care

BackgroundProviding patient-centered health care requires that patient needs, preferences, and valued outcomes are more fully integrated into all decisions. Patient-reported outcome (PRO) measures provide unique information from the patient perspective on overall health, symptoms, burden, and treatment response. ObjectiveWe sought to describe applications of PROs in clinical settings and considerations for implementation from the perspectives of PRO researchers, clinicians, administrators, policy makers, and patients attending a multidisciplinary meeting. DiscussionClinical applications of PROs include individual level use for medical decision making and aggregate use for comparative effectiveness research, program evaluation, quality improvement, and performance assessments. Considerations of feasibility on workflow impact and patient burden, display of results, and administration frequency are important. PROs with strong psychometric properties, actionable thresholds, and interpretable results should be selected. We provide current exemplars of PRO use in various clinical applications, initial lessons learned, and highlight conceptual, logistical, and consequential considerations of PRO data collection. A research agenda is proposed to address critical knowledge gaps. In conclusion, PROs can be used in clinical settings to support patient-centered care. This requires an assessment of feasibility in the intended setting of use, measurement considerations, and process measures to optimize integration and use.

Use of patient-reported outcomes in outpatient settings as a means of patient involvement and self-management support – a qualitative study of the patient perspective

Rationale, aims and objectives Patient-reported outcomes (PRO) is being implemented in clinical practice across different healthcare settings with various purposes. Involving the patients in reporting outcomes may increase their attention to symptoms and thereby support their self-management. The aim of the present study was to describe patients’ experiences with a web-based PRO system where patients fill in a PRO questionnaire at home or in the outpatient clinic prior to a consultation. Moreover, the study aimed to explore how PRO influenced the interaction between patients and clinicians during the consultation.Methods Through participant observations of nine consultations and 12 semi-structured interviews with patients after the consultation this interpretive description study explored patients’ experiences with the PRO system. The PRO included self-assessment on health-related quality of life, symptoms, and well-being. Patients who visited the outpatient clinic at Department of Renal Medicine at Aarhus University Hospital in the Central Denmark Region in February and March 2014 and in March and August 2015 were invited to participate. We used a convenience sampling approach to recruit patients who had completed at least two PRO questionnaires.Results The analysis revealed rudiments of PRO in clinical practice leading to an increased understanding of their chronic disease, patient-centred communication and an additional focus on psychosocial problems. However, the very application of PRO in the outpatient clinic and the patient attitudes were substantial and crucial barriers for PRO as a method to achieve patient involvement and self-management.Conclusion The use of PRO in outpatient consultations may support patients' self-management by a) impelling patient-centred communication in the consultation, b) legitimising talk about psychosocial problems, and c) increasing the patients' understanding of their disease. Yet, applying PRO into clinical practice does not automatically involve the patients and support their self-management. We suggest supplementary clinical initiatives to strengthen the patient involving benefits of PRO.

환자성과보고 및 삶의 질 도구 개념 및 적용: 국내의 적용 도입 제언

Objectives: This study reviewed the concepts and applications of Patient-Reported Outcomes (PRO) and measures of Quality of Life (QoL). Methods: We overviewed the current measures of PROs and QoL measures, development methods for measures, and clinical and policy applications with various examples. Results: Clinicians use PROs to make decisions for better effective treat ments in clinical settings. Health providers or administrators use PROs to monitor and evaluate quality of services for clinical improvements and, to make decisions for efficient managments for fi nancial reason. Also, PROs are good tools to observe patients’ responses in new clinical trials and to confirm patients’ compliance of treatments. Given the current these versatile applications of PROs in other country, we think there are good practical lessons for clinical or policy implications in Korea. Despite many efforts to use PROs in local studies already, there are still rooms to apply for prac tical policy applications with PROs. Conclusion: PROs have become significant measures to prove treatments or to make decision for patients with chronic illness. We suggest that Korean clinicians and policy makers should pay more attention to try feasible innovative PROs applications with realworld data.