Integration Of Patient-reported Outcomes Research Articles

Use of Patient-Reported Outcomes in Risk Prediction Model Development to Support Cancer Care Delivery: A Scoping Review.

The integration of patient-reported outcomes (PROs) into electronic health records (EHRs) has enabled systematic collection of symptom data to manage post-treatment symptoms. The use and integration of PRO data into routine care are associated with overall treatment success, adherence, and satisfaction. Clinical trials have demonstrated the prognostic value of PROs including physical function and global health status in predicting survival. It is unknown to what extent routinely collected PRO data are used in the development of risk prediction models (RPMs) in oncology care. The objective of the scoping review is to assess how PROs are used to train risk RPMs to predict patient outcomes in oncology care. Using the scoping review methodology outlined in the Joanna Briggs Institute Manual for Evidence Synthesis, we searched four databases (MEDLINE, CINAHL, Embase, and Web of Science) to locate peer-reviewed oncology articles that used PROs as predictors to train models. Study characteristics including settings, clinical outcomes, and model training, testing, validation, and performance data were extracted for analyses. Of the 1,254 studies identified, 18 met inclusion criteria. Most studies performed retrospective analyses of prospectively collected PRO data to build prediction models. Post-treatment survival was the most common outcome predicted. Discriminative performance of models trained using PROs was better than models trained without PROs. Most studies did not report model calibration. Systematic collection of PROs in routine practice provides an opportunity to use patient-reported data to develop RPMs. Model performance improves when PROs are used in combination with other comprehensive data sources.

The use of PROMs (patient-reported outcome measures) and PREMs (patient-reported experience measures) in Cardiology: current state and applications to improve patient care

The integration of patient-reported outcomes and experiences through PROMs and PREMs tools represents a significant evolution in the quality of care and clinical practice. This article reviews the state of the art and the application experiences of these tools, focusing on their impact on the management of cardiovascular diseases. The use of PROMs and PREMs allows for a more comprehensive assessment of patient well-being by integrating with traditional clinical indicators. An increasing number of studies suggests that the systematic collection of these data can help physicians in better identifying individual patient's needs, improving doctor-patient communication, and personalizing therapies. In aggregate form, these data can be used to improve the quality of services. This article explores the main international experiences, starting from the activities carried out in this field by the European Society of Cardiology, the challenges in implementing such tools, and the prospects for a more widespread adoption in daily clinical practice. It emphasizes the activities carried out in Italy by the Fondazione Toscana Gabriele Monasterio and the Management and Healthcare Laboratory of the Scuola Superiore Sant'Anna of Pisa, highlighting the importance of validated tools, appropriate technologies, and a cultural change to promote patient-centered care.

The status of drug evaluation in older adults in the United Kingdom: Bridging the representation gap.

Older adults are persistently underrepresented in clinical drug trials worldwide, despite increasing multiple long-term conditions and significant prescribing in this demographic. We discuss systemic challenges such as the exclusion of people with comorbid conditions and the lack of assessment for comorbidities as modifiers of treatment effects and highlight the rising trend of polypharmacy, especially among the oldest age groups, which is linked to a significant percentage of unplanned hospitalizations and medication errors. The consequences of these trends prompted the United Kingdom National Overprescribing review, culminating in a set of recommendations for drug development tailored to older adults. Building on this, two critical reports released in April 2023 by the International Longevity Centre (ILC) and the Nuffield Council on Bioethics (NCOB) are discussed. These reports emphasize the importance of diversity and inclusion in clinical trials, advocating for ethical frameworks and methodologies that cater to the complex needs of older adults. The development of inclusive criteria, innovative statistical methodologies, and the integration of patient-reported outcomes are needed to address the persistent barriers to older adult participation in research, suggesting that pragmatic trials, exemplified by the UK's RECOVERY trial during the COVID-19 pandemic, could pave the way for more inclusive research practices.

Clinic-based perspectives on the integration of patient-reported outcomes (PROs) in a tertiary cancer center.

This study examines providers' and clinic staff's perspectives on patient-reported outcomes (PROs) implementation at an academic medical center. An anonymous and voluntary survey was administered to Henry Ford Cancer providers and clinic staff 18months after PROs program implementation in September 2020, to obtain their feedback on perceived barriers, impact on workflows, and PROs administration frequency in routine cancer care. A total of 180 providers and 40 clinic staff were invited to complete the survey; 31% and 63% completed the survey, respectively. Approximately 68% of providers reported that electronically integrated PROs scores were either beneficial or somewhat beneficial to their patients, while only 28% of the clinic staff reported that PROs were beneficial or somewhat beneficial to patients. According to the clinic staff, the most common barriers to PROs completion included lack of patients' awareness of the utility of the program with respect to their care, patients' health status at check-in, and PROs being offered too frequently. There is favorable acceptance of the PROs program by providers, but clinic staff found it less favorable. Interventions to address barriers and improve program engagement are needed to ensure broad adoption of PROs in oncology practice.

Humanization Guide of the Spanish Society of Hospital Pharmacy for patients with inflammatory immune-mediated diseases

ObjectiveThis study reports on the results of a project conducted by the Spanish Society of Hospital Pharmacy with patients with immune-mediated inflammatory diseases, with the following objectives: to understand the experience of patients living with these diseases and the role of healthcare workers in such experience, and to identify opportunities to promote or boost humanization in hospital pharmacy units. MethodA user-centered design methodology was used, implementing exploratory and qualitative research tools. Led by a managing team made up of experts in the methodology, a variety of people participated in this project. The team comprised representatives of patients with immune-mediated inflammatory diseases, healthcare workers responsible for their care, members of the immune-mediated inflammatory disease working group of the Spanish Society of Hospital Pharmacy, and members of two patient advocacy organizations (Spanish Association of Persons with Chronic Immune-Mediated Inflammatory Diseases and the Spanish Association of Patients with Psoriasis). The research tools used included in-depth interviews, patients’ diaries, ethnographic studies, and co-creation workshops. ResultsFive initiatives were identified as best practices to be implemented: The creation of functional or comprehensive care units; shared medical records; integration of patient-reported outcomes with patient experiences; implementation of the “capacity, motivation, opportunity” pharmaceutical care model; and a closer interaction with patient advocacy organizations. Six opportunities to improve the current situation were selected as priority areas for hospital pharmacy departments: spreading knowledge about immune-mediated inflammatory diseases; promoting a multidisciplinary approach to these diseases; generating awareness on the role of hospital pharmacists; revisiting the internal organization of pharmacy departments; establishing closer relationships with patients; and seeing things from the patients’ point of view. Ten smart humanization initiatives were proposed and classified in an impact-effort matrix: “Demystifying IMID”, “IMID teen challenge”, “Patient-care academy”, “Satellite consultation”, “IMID network”, “A click away from the pharmacy”, Medicines poker”, “Patient-to-patient consultation”, “Pharma-friendly consultation”, and “Patient-centered IMID sessions”. ConclusionsThis Annex to the Spanish Society of Hospital Pharmacy’s Guidelines for the Humanization of Hospital Pharmacy Units intends to promote a humanizing culture, bringing to the fore the unique value of every single patient suffering from an immune-mediated inflammatory disease, including their family and friends and their beliefs and needs, preserving their dignity.

The prognostic value of quality of life in atrial fibrillation on patient value

BackgroundIn this study, the prognostic value of AF-related quality of life (AFEQT) at baseline on Major Adverse Cardiovascular Events (MACE) and improvement of perceived symptoms (EHRA) was assessed. Furthermore, the relationship between QoL and AF-related hospitalizations was assessed.MethodsA cohort of AF-patients diagnosed between November 2014 and October 2019 in four hospitals embedded within the Netherlands Heart Network were prospectively followed for 12 months. MACE was defined as stroke, myocardial infarction, heart failure and/or mortality. Subsequently, MACE, EHRA score improvement and AF-related hospitalizations between baseline and 12 months of follow-up were recorded.ResultsIn total, 970 AF-patients were available for analysis. In analyses with patients with complete information on the confounder subset 36/687 (5.2%) AF-patients developed MACE, 190/432 (44.0%) improved in EHRA score and 189/510(37.1%) were hospitalized during 12 months of follow-up. Patients with a low AFEQT score at baseline more often developed MACE (OR(95%CI): 2.42(1.16–5.06)), more often improved in EHRA score (OR(95%CI): 4.55(2.45–8.44) and were more often hospitalized (OR(95%CI): 4.04(2.22–7.01)) during 12 months post diagnosis, compared to patients with a high AFEQT score at baseline.ConclusionsAF-patients with a lower quality of life at diagnosis more often develop MACE, more often improve on their symptoms and also were more often hospitalized, compared to AF-patients with a higher quality of life. This study highlights that the integration of patient-reported outcomes, such as quality of life, has the potential to be used as a prognostic indicator of the expected disease course for AF.

Improving Outcome-Driven Care in Multiple Myeloma Using Patient-Reported Outcomes: A Qualitative Evaluation Study.

Multiple myeloma is an incurable disease with a considerable illness and treatment burden, which negatively impacts patients' quality of life. This study aimed to evaluate the implementation of multiple myeloma care in five Dutch hospitals, related to the three objectives of outcome-driven care, which are defined as (1) providing information for shared decision making in individual patient care, (2) supporting the learning capacity of healthcare professionals and healthcare institutions through benchmarking and (3) developing outcome-driven and patient-centred contracting by health insurers. In this qualitative study, semi-structured interviews about experiences with patient-reported outcomes were conducted with patients, healthcare professionals and other stakeholders 2 years after implementation. Data were thematically analysed, and emerging topics were clustered around the three objectives of outcome-driven care. A total of 46 interviews were held (15 with patients, 16 with professionals and 15 with other stakeholders) that showed patients with multiple myeloma were willing to complete patient-reported outcomes, although integration of patient-reported outcomes in shared decision making fell short in clinical practice. Aggregated patient-reported outcomes were considered important for improving quality of care; however, data collection and data exchange are hindered by privacy legislation, limitations of IT systems and a lack of data standards. Patient-reported outcomes were expected to contribute to cost-effective multiple myeloma treatment, yet outcome-driven reimbursement is still lacking. Outcome-driven multiple myeloma care using patient-reported outcomes is feasible, provided that (1) patient-reported outcomes and shared decision making are integrated into clinical practice, (2) legal and technical obstacles hindering data collection are removed and (3) health insurers adjust their reimbursement plans to facilitate outcome-driven care.

Integration of patient-reported outcomes into survivorship care.

271 Background: Patient reported outcomes (PRO) can be valuable clinical tools to embed the voice of patients into the clinical experience. The use of PROs in the context of cancer survivorship is relatively under-explored. Methods: Disease-specific modules of the MD Anderson Symptom Inventory (MDASI) PRO were integrated into the electronic health record (EHR), and distributed 3-7 days prior to survivorship clinic visits through the patients’ EHR portal. Patients with virtual visits were called 24 hours prior, instructed how to video link, and how to complete the MDASI PRO. For patients who completed the PRO electronically, results were reviewed during clinic visit. High symptom alerts (> = 7) for four key symptoms were established and triggered an automatic message to care teams for review. Results: From Sept 1, 2020 – August 31, 2021, 2,196 PRO surveys were sent to patients with 1,268 submitting results (57.74%) (see Table). Within specific clinics, the submission rates varied greatly between in-person and virtual appointments (33% vs. 83%). Submission rates varied by clinics, with responses ranging from 28.57% - 73.59%. Clinics with higher overall rates had a higher proportion of virtual visits. Conclusions: Electronic distribution of PROs can be successfully integrated into long term survivorship clinic visits. Virtual visits had overall much higher PRO response rates, due to pre-visit workflows which encouraged the completion of PROs. We conclude that patient education and real time support is needed to facilitate patients’ completion of PRO surveys through the electronic portal.[Table: see text]

Integration of Patient-reported Outcomes in a Total Joint Arthroplasty Program at a High-volume Academic Medical Center

Introduction:Despite widely appreciated barriers to successful clinical implementation, the literature regarding how to operationalize electronic health record-integrated patient-reported outcomes (PROs) remains sparse. We offer a detailed summary of the implementation of PROs into the standard of care at a major tertiary academic medical center.Methods:Collection of four Patient-Reported Outcomes Measurement Information System computer adaptive tests was piloted in a large academic orthopaedic surgery ambulatory clinic starting in October 2016. The Patient-Reported Outcomes Measurement Information System computer adaptive tests (Physical Function, Pain Intensity, Pain Interference, and Ability to Return to Social Roles and Activities) were initially implemented as manual order sets to be administered before surgery through 2 years after surgery. Completion rate over time, mean time to completion for all PRO domains, and the overall distribution of symptom severity were used to evaluate the success of the pilot. A subsequent optimization and redesign of the pilot was conducted using tablets, automation of questionnaire deployment, and improved results review to address obstacles encountered during the pilot phase.Results:Two thousand nine distinct joint arthroplasty patients (mean age = 65) completed at least one set of PRO assessments, with overall completion rates reaching 68% and mean completion time of 3 minutes. Focal points during the implementation process included engagement and training of staff, selection of an appropriate patient population and outcome measures, and user friendly data displays for patients and providers.Conclusion:Our pilot program successfully demonstrated that PROs can be administered, scored, and made immediately available within the electronic health record to patients and their providers with minimal disruption of clinical workflows. Although considerable operational and technological challenges remain, we found that the implementation of PROs in clinical care within an ambulatory practice at an academic medical center can be achieved through a constellation of several key factors.

Integration of patient-reported outcomes (PROs) for personalized symptom management in "real-world" oncology practices: a population-based cohort comparison study of impact on healthcare utilization.

The use of patient-reported outcomes (PROs) for routine cancer distress screening is endorsed globally as a quality-care standard. However, there is little research on the integration of PROs in "real-world" oncology practices using implementation science methods. The Improving Patient Experience and Health Outcome Collaborative (iPEHOC) intervention was established at multisite disease clinics to facilitate the use of PRO data by clinicians for precision symptom care. The aim of this study was to examine if patients exposed to the intervention differed in their healthcare utilization compared with contemporaneous controls in the same time frame. We used a PRE- and DURING-intervention population cohort comparison study design to estimate the effects of the iPEHOC intervention on the difference in difference (DID) for relative rates (RR) for emergency department (ED) visits, hospitalizations, psychosocial oncology (PSO), palliative care visits, and prescription rates for opioids and antidepressants compared with controls. A small significantly lower Difference in Difference (DID) (- 0.223) in the RR for ED visits was noted for the intervention compared with controls over time (0.947, CI 0.900-0.996); and a DID (- 0.0329) for patients meeting ESAS symptom thresholds (0.927, CI 0.869-0.990). A lower DID in palliative care visits (- 0.0097), psychosocial oncology visits (- 0.0248), antidepressant prescriptions (- 0.0260) and an increase in opioid prescriptions (0.0456) in the exposed population compared with controls was also noted. A similar pattern was shown for ESAS as a secondary exposure variable. Facilitating uptake of PROs data may impact healthcare utilization but requires examination in larger scale "real-world" trials.

The Use of Patient-Reported Outcomes in Patients Treated With Maintenance Hemodialysis: A Perspective

There is increasing interest in the integration of patient-reported outcomes (PROs) into health care research and clinical practice for the benefit of patients with end-stage kidney disease receiving hemodialysis. In a research setting, PROs can be used as a patient-centered primary or secondary outcome in clinical studies. In routine care, PRO data may be used to support service delivery through benchmarking and audit or inform and enhance the care of the individual patient by improving patient-clinician communication. Despite evidence demonstrating the potential benefits of PROs and prioritization of these outcomes by patients, their use in kidney disease remains limited. Although there are significant methodological and operational challenges for the widespread integration of PROs, there is now consensus that this area should be at the forefront of clinical research and implementation science. We discuss the current use of PROs for patients with end-stage kidney disease receiving hemodialysis and identify a roadmap for increasing the evidence base and introducing PROs into mainstream clinical practice.

Implementing Recommended Long Term Follow up Screening and Preventive Practices in an Allogeneic Hematopoietic Cell Transplant Survivorship Clinic

The number of allogeneic hematopoietic cell transplantation (HCT) survivors is projected to increase and guidelines for screening and management of late effects have been established. Although the value of a systematic process for the long-term care of HCT survivors and screening of late effects is increasingly recognized, best practices for the implementation of survivorship care delivery has not been well described. In October 2016, we established a Survivorship Clinic for allogeneic HCT recipients in our Blood and Marrow Transplant (BMT) Program. A consultative model aimed to augment care provided by the patient's primary transplant and primary care physician was felt to best fit our program's needs. Patients (pts) are seen by a Nurse Practitioner (NP) and social worker (SW) at day 100 and 1 year visits. Visits include a comprehensive history and physical, symptom assessment, and graft-versus-host disease evaluation, as well as review and provision of a treatment summary and care plan. 1-year recommended assessments include: bone density scan, vitamin D, TSH, lipid panel, HbA1c, Ferritin, pulmonary function tests (PFTs), ophthalmic exam, and mammogram and pelvic exam (women). We performed a formal review of follow up with recommended screening guidelines among pts seen in our Survivorship Clinic from 2016-2018. Since its establishment, 161 pts received allogeneic HCT in our Program, of whom 131 pts have been seen at day 100 and 42 have been seen at 1-year. Patients not seen at day 100 were due to relapse, death or acute illness where they were not able to attend the clinic visit. Among pts seen at day 100 but not at 1 year, 7 were international, 2 were deferred due to relapse, 12 died prior to one year follow up, one transferred care to another facility and 67 have not reached their 1-year follow up. Of 42 pts seen at 1 year, all have received a complete treatment summary and care plan at both day 100 and 1 year. 35 pts had an evaluation and follow up with their transplant SW for psychosocial assessment. 41 pts had a bone density scan completed. All 42 pts completed a screening TSH, vitamin D, lipid panel, HbA1c, Ferritin, and PFTs. 36 saw ophthalmology for a yearly exam. Of the 20 women seen at 1 year, all 20 had mammograms done and 19 had gynecologic exams. In summary, this review of our NP run BMT survivorship clinic demonstrates feasibility and a high rate of adherence to recommended late effects screening practices for HCT survivors. As the survivorship program continues to grow, further integration of patient-reported outcomes and interventional research on late effects to improve the well-being of long-term survivors is planned.

Provider perspectives on the integration of patient-reported outcomes in an electronic health record.

ObjectiveIntegrating patient-reported outcomes (PROs) into electronic health records (EHRs) can improve patient-provider communication and delivery of care. However, new system implementation in health-care institutions is often accompanied by a change in clinical workflow and organizational culture. This study examines how well an EHR-integrated PRO system fits clinical workflows and individual needs of different provider groups within 2 clinics.Materials and MethodsNorthwestern Medicine developed and implemented an EHR-integrated PRO system within the orthopedics and oncology departments. We conducted interviews with 11 providers who had interacted with the system. Through thematic analysis, we synthesized themes regarding provider perspectives on clinical workflow, individual needs, and system features.ResultsOur findings show that EHR-integrated PROs facilitate targeted conversation with patients and automated triage for psychosocial care. However, physicians, psychosocial providers, and medical assistants faced different challenges in their use of the PRO system. Barriers mainly stemmed from a lack of actionable data, workflow disruption, technical issues, and a lack of incentives.DiscussionThis study sheds light on the ecosystem around EHR-integrated PRO systems (such as user needs and organizational factors). We present recommendations to address challenges facing PRO implementation, such as optimizing data collection and auto-referral processes, improving data visualizations, designing effective educational materials, and prioritizing the primary user group.ConclusionPRO integration into routine care can be beneficial but also require effective technology design and workflow configuration to reach full potential use. This study provides insights into how patient-generated health data can be better integrated into clinical practice and care delivery processes.

Longitudinal Changes of Impairments in Health-Related Quality of Life in Lower-Risk MDS Patients: A European Leukemianet Study

Introduction Patient perception and perspective have become relevant in individualised therapy planning in MDS. Thus, integration of patient-reported outcomes (PRO), including health-related quality of life (HRQoL), in studies and in clinical practice is essential. We demonstrated recently pronounced impairments in HRQoL in patients with MDS (Stauder et al., Leukemia 2018). However, longitudinal data on aspects of HRQoL in MDS are rare.Objectives 1. To describe longitudinal changes of HRQoL in MDS and 2. To compare the time course in different patient subgroups to define patients at high risk of deterioration of HRQoL.Methods The EUMDS Registry is a prospective, non-interventional longitudinal study, enrolling newly diagnosed patients with IPSS low or intermediate-1 MDS from 143 haematology centres in 17 European countries and Israel. HRQOL was assessed by EQ-5D questionnaire. Patients were selected, if they fully completed the EQ-5D score (five dimensions and VAS) at baseline and at 6 and 12 months, resulting in a total of 743 subjects at 86 centres in 15 countries. Differences in response for the five EQ-5D dimensions between patients subgroups were evaluated using chi-squareMcNemar tests. For EQ-VAS, the mean score with standard deviation was calculated. Wilcoxon's signed ranks tests were conducted to identify changes over time between HRQOL values at baseline and at 6, 12 months.Results•Moderate/severe impairments at initial diagnosis were observed in the dimensions mobility (39.4%), self-care (10.2%), usual activities (32.6%), pain discomfort (46.6%) and anxiety/depression (36.7%).•As compared with baseline a pronounced increase in moderate/severe problems was observed at 12 months in the dimensions self-care (10.2% (baseline) vs 15.5% (12 mo); p=0.003) and in usual activities (32.6% vs 40.6%; p=0.001). In contrast, self-reported mobility, pain and anxiety/depression did not change significantly. Decrease in VAS over time revealed a trend toward significance (75 vs. 70; p=0.056).•More pronounced impairment of HRQOL was most significantly observed in patients of advanced age: 60-75 yrs in self-care 8.3% vs 14.3% (p=0.016) and in usual activities 28% vs 35.7% (p=0.032); in persons 75+ years in self-care 14.2% vs 19.8% (p=0.058) and in usual activities 48.7% vs 50.3% (p=0.003). Similarly, VAS significantly decreased in the latter group from 70 to 66 (p=0.038).•Increases in impairments were most prominent in male patients in self-care (9.7 vs 16.7%; p=0.002) and in usual activities (29.4 vs 38.7%; p=0.003), whereas in women HRQoL at the different time points was not significantly different.•Pronounced decreases in HRQoL aspects was observed in anemic patients (Hb-levels <10g/dl) at initial diagnosis: mobility 47.4 vs 55.2% (p=0.06), self-care 13.5 vs 21.1% (p=0.015), usual activities 41.3 vs 52.7% (p=0.006), pain/discomfort 43.3 vs 55.6% (p=0.058) and VAS (70 vs 68; p=0.051). A reduction in HRQoL was observed even in patients with a Hb-level ≥10 g/dl in the dimension self-care (7.9 vs 12.1%; p=0.042).•Pronounced decreases in problems in HRQoL were observed in anemic patients (Hb<10 g/dL) who received transfusions in self-care (18.1% vs 25.6%; p=0.029), in usual activities (43.6% vs 61.5%; p=0.038), and in VAS (67.3 vs 61.9; p=0.003).•Transfusion dependent patients were at high risk to develop impairments in VAS (70 vs 64; p=0.006) and in most dimensions of EQ-5D (mobility 50.2 vs 62%, p=0.017), self-care (8.8 vs 11.5%, p=0.017), usual activities (41.6 vs 62.9%, p=0.01) and pain/discomfort (48.3 vs 58.5%, p=0.038).Conclusions Low-risk MDS patients report relevant restrictions in distinct dimensions at initial diagnosis. A relevant drop in HRQoL is observed at 12 months particularly in self-care and in usual activities. Patients of advanced age, males and those with initial low Hb-levels most frequently reported declines in HRQoL. Transfusion-need represents a relevant predictor of deterioration of HRQoL. These analyses form the basis to identify vulnerable patients and to tailor individualized interventions and treatment approaches. Analyses are planned to unravel the role of intervention therapies on observed changes in HRQoL. DisclosuresStauder:Teva: Research Funding; Novartis: Honoraria, Membership on an entity's Board of Directors or advisory committees; Celgene: Honoraria, Membership on an entity's Board of Directors or advisory committees. Fenaux:Celgene: Honoraria, Research Funding; Jazz: Honoraria, Research Funding; Roche: Honoraria; Otsuka: Honoraria, Research Funding; Janssen: Honoraria, Research Funding. Garelius:novartis: Honoraria. Efficace:Incyte: Consultancy; Amgen: Consultancy; TEVA: Consultancy; Bristol Meyers Squibb: Consultancy; Orsenix: Consultancy; Seattle Genetics: Consultancy; Lundbeck: Research Funding; TEVA: Research Funding; AMGEN: Research Funding. de Witte:Amgen: Consultancy, Research Funding; Celgene: Honoraria, Research Funding; Novartis: Research Funding.

Clinical decision-making and health-related quality of life during first-line and maintenance therapy in patients with advanced non-small cell lung cancer (NSCLC): findings from a real-world setting

BackgroundMaintenance therapy (MT) with pemetrexed has been shown to improve overall and progression-free survival of patients with non-squamous non-small cell lung cancer (NSCLC), without impairing patients’ health-related quality of life (HRQOL) substantially. Comprehensive data on HRQOL under real-life conditions are necessary to enable informed decision-making. This study aims to (1) assess HRQOL during first-line chemotherapy and subsequent MT and (2) record patients’ and physicians’ reasons leading to clinical decisions on MT.MethodsPatients treated for NSCLC at three Austrian medical centres were included. HRQOL was assessed at every chemotherapy cycle using the EORTC QLQ-C30/+LC13 questionnaire. Semi-structured interviews were conducted before MT initiation and at the time of discontinuation to evaluate patients’ and physicians’ reasons for treatment decisions. Longitudinal QOL analysis was based on linear mixed models.ResultsSixty-one (73%) out of 84 patients were considered for MT. Thirty-six patients (43%) received MT and 29 (35%) discontinued therapy. Decisions on MT initiation (in 20 cases by the physician vs 4 by the patient) and discontinuation (19 vs 10) were mainly voiced by the physician. Treatment toxicity of first-line chemotherapy was the main reason for rejection of MT in patients with stable disease and was more often indicated by patients than clinicians. HRQOL data were collected from 83 patients at 422 assessment time points and indicated significantly lower symptom severity during MT compared with first-line therapy for nausea and vomiting (p = 0.006), sleep disturbances (p < 0.001), appetite loss (p = 0.043), constipation (p = 0.017) and chest pain (p = 0.022), and a deterioration in emotional functioning (p = 0.023) and cognitive functioning (p = 0.044) during MT.ConclusionsOur results indicate that HRQOL and symptom burden improve between first-line treatment to MT in some respects, although some late toxicity persists. Discrepancies between patients’ and physicians’ perception of reasons for rejecting MT were evident. Thus, the integration of patient-reported outcomes, such as HRQOL, is required to enable shared decision-making and personalised healthcare based on mutual understanding of treatment objectives.

Development of a radiation oncology-specific prospective data registry for clinical research and quality improvement: A clinical workflow-based solution.

197 Background: The computerized ‘paperless’ medical recording system has transformed the modern health information system and serves as an idea platform for cancer registry development, particularly in a specialty like radiation oncology, where technological advances generate unprecedented amounts of data. Methods: From May 2011 to May 2015, physicians prospectively inputted data on patients seen during consultation in the Department of Radiation Oncology at UCLA. Using a customized interface established between an in-house registry and a commercially-available, hospital-based electronic medical record system (Epic Systems, Inc. Verona, WI), a parcel was created for data deposition, which was also linked to the Aria Treatment Planning Station (Varian Medical Systems, Inc., Palo Alto, CA). This registry was designed to assimilate into routine physician work-flow and was based on the completion of tabular entries, which were templated by disease sites. The total number of data fields per disease site ranged from 9 to 73 (median, 21). Results: A total of 7,646 patients were logged into the registry. Primary disease sites were prostate (N = 1,247), breast (N = 1157), head/neck (N = 726), central nervous system (N = 638), lung (N = 439), brain metastasis (N = 349), gastrointestinal (N = 238), gynecologic (N = 234), other (N = 2,618). The mean data capture completion rate by physicians was 55% (range, 32 to 65%); however, this rate did not differentiate between true incomplete (data available but not collected), versus data that was either unavailable, not required, or not applicable. A total of 46 independent, investigator-initiated research studies have been undertaken using queries supported by the registry from multiple access points, 8 of which were published in peer-reviewed journals. Conclusions: The development of a radiation oncology-specific registry not only enhanced research efficiency and facilitated quality assurance, but also fostered data reuse and promoted self-education by producing quality information to guide clinical practice. Our next steps include the integration of patient-reported outcomes through radiation oncology-specific surverys, the documentation of cost of delivery of care of specific treatment pathways, and the implementation of data collection processes in the community.

Logistical Considerations for Integrating Patient-Reported Outcomes in Multiregional Clinical Trials

Patient-reported outcomes (PROs) are increasingly used in clinical trials for a variety of purposes, including demonstration of efficacy as a primary endpoint. Study teams face many unique logistical challenges when implementing PROs in multiregional clinical trials, including in terms of the resources needed to create questionnaires, train staff in their use, andanalyze patient feedback to them. For example, creation and validation of novel questionnaires require special expertise. Being aware of such challenges early in the process will enable successful integration of PROs in multiregional clinical trials.

The role of technical advances in the adoption and integration of patient-reported outcomes in clinical care.

Patient-reported outcomes (PROs) are gaining recognition as key measures for improving the quality of patient care in clinical care settings. Three factors have made the implementation of PROs in clinical care more feasible: increased use of modern measurement methods in PRO design and validation, rapid progression of technology (eg, touchscreen tablets, Internet accessibility, and electronic health records), and greater demand for measurement and monitoring of PROs by regulators, payers, accreditors, and professional organizations. As electronic PRO collection and reporting capabilities have improved, the challenges of collecting PRO data have changed. To update information on PRO adoption considerations in clinical care, highlighting electronic and technical advances with respect to measure selection, clinical workflow, data infrastructure, and outcomes reporting. Five practical case studies across diverse health care settings and patient populations are used to explore how implementation barriers were addressed to promote the successful integration of PRO collection into the clinical workflow. The case studies address selecting and reporting of relevant content, workflow integration, previsit screening, effective evaluation, and electronic health record integration. These case studies exemplify elements of well-designed electronic systems, including response automation, tailoring of item selection and reporting algorithms, flexibility of collection location, and integration with patient health care data elements. They also highlight emerging logistical barriers in this area, such as the need for specialized technological and methodological expertise, and design limitations of current electronic data capture systems.

Using Technology to Improve Data Capture and Integration of Patient-Reported Outcomes Into Clinical Care: Pilot Results in a Busy Colorectal Unit

Patient-reported outcomes are traditionally collected through paper questionnaires. This process is labor intensive and costly. The aim of this study was to assess the feasibility of using tablet computing technology to streamline the questionnaire intake process and integrate patient-reported outcomes into electronic health records for access at the point of care. Response-driven electronic questionnaires for patients with colorectal disorders were designed. The impact of this technology on clinical workflow and questionnaire response rates was assessed. Historical data on paper questionnaire response rates over a similar time period were compared with the electronic data. From June through July 2009, data from 103 patient visits to 2 surgeons over 8 clinic days were included. Females comprised 69.7% of the sample with a median age of 49 (range, 18-84) years. When patients checked in 30 minutes early, 82% completed the forms by their scheduled visit time. The questionnaires response rate was 96%. Scores were calculated automatically and included in the electronic health record. Median questionnaire completion time was 15 (interquartile range, 8-21) minutes. Conversely, collection rates of historical data for the same surgeons over a 2-month period revealed that 152 patient visits yielded 38 paper questionnaires, a response rate of 25%. Collection of patient-reported outcomes by use of tablet technology and automatic transmission into the electronic chart with data storage for later use is feasible. This process can overcome many of the inefficiencies associated with paper questionnaires.