Dataset Information

Electronic Patient-Reported Outcome Measures in Radiation Oncology: Initial Experience After Workflow Implementation.

ABSTRACT: BACKGROUND:Mobile health (mHealth) technologies are increasingly used in various medical fields. However, the potential of mHealth to improve patient care in radiotherapy by acquiring electronic patient reported outcome measures (ePROMs) during treatment has been poorly studied so far. OBJECTIVE:The aim of this study was to develop and implement a novel Web app (PROMetheus) for patients undergoing radiotherapy. Herein, we have reported our experience with a focus on feasibility, patient acceptance, and a correlation of ePROMs with the clinical course of the patients. METHODS:In the period between January and June 2018, 21 patients used PROMetheus to score side effects, symptoms, and quality of life-related parameters during and after their treatment. Items of the Patient Reported Outcome version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) were chosen based on the primary site of disease, 27 items for head and neck tumors, 21 items for thoracic tumors, and 24 items for pelvic tumors. RESULTS:In total, 17 out of the 21 patients (81%) regularly submitted ePROMs and more than 2500 data points were acquired. An average of 5.2, 3.5, and 3.3 min was required to complete the head and neck, thorax, and pelvis questionnaires, respectively. ePROMS were able to detect the occurrence of both expected and unexpected side effects during the treatment. In addition, a gradual increase in the severity of side effects over the course the treatment and their remission afterward could be observed with ePROMs. In total, 9 out of the 17 patients (53%), mostly those with head and neck and thoracic cancers, reported PRO-CTCAE grade III or IV fatigue with severe impairments of activities of daily life. CONCLUSIONS:This study shows the successful implementation of an ePROM system and a high patient acceptance. ePROMs have a great potential to improve patient care in radiotherapy by providing a comprehensive documentation of symptoms and side effects, especially of ones that are otherwise underreported.

SUBMITTER: Hauth F

PROVIDER: S-EPMC6685133 | biostudies-literature | 2019 Jul

REPOSITORIES: biostudies-literature

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Electronic Patient-Reported Outcome Measures in Radiation Oncology: Initial Experience After Workflow Implementation.

Hauth Franziska F Bizu Verena V App Rehan R Lautenbacher Heinrich H Tenev Alina A Bitzer Michael M Malek Nisar Peter NP Zips Daniel D Gani Cihan C

JMIR mHealth and uHealth 20190724 7

<h4>Background</h4>Mobile health (mHealth) technologies are increasingly used in various medical fields. However, the potential of mHealth to improve patient care in radiotherapy by acquiring electronic patient reported outcome measures (ePROMs) during treatment has been poorly studied so far.<h4>Objective</h4>The aim of this study was to develop and implement a novel Web app (PROMetheus) for patients undergoing radiotherapy. Herein, we have reported our experience with a focus on feasibility, p ...[more]

PMID: 31342906

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Project description:PurposeDespite evidence for clinical benefits, recommendations in guidelines, and options for electronic data collection, routine assessment of patient-reported outcomes (PROs) is mostly not implemented in clinical practice. This study aimed to plan, conduct and evaluate the implementation of electronic PRO (e-PRO) assessment in the clinical routine of an inpatient radiation oncology clinic.MethodsThe guideline- and evidence-based, stepwise approach of this single-center implementation study comprised preparatory analyses of current practice, selection of assessment instruments and times, development of staff training, and evidence-based recommendations regarding the use of the e-PRO assessment, as well as on-site support of the implementation. Process evaluation focused on potential clinical benefit (number of documented symptoms and supportive measures), feasibility and acceptance (patient contacts resulting in completion/non-completion of the e-PRO assessment, reasons for non-completion, preconditions, facilitators and barriers of implementation), and required resources (duration of patient contacts to explain/support the completion).ResultsSelection of instruments and assessment times resulted in initial assessment at admission (EORTC QLQ-C30, QSR 10), daily symptom monitoring (EORTC single items), and assessment at discharge (EORTC QLQ-C30). Recommendations for PRO-based clinical action and self-management advice for patients concerning nine core symptoms were developed. Staff training comprised group and face-to-face meetings and an additional e-learning course was developed. Analyses of clinical records showed that e-PRO assessment identified more symptoms followed by a higher number of supportive measures compared to records of patients without e-PRO assessment. Analysis of n = 1597 patient contacts resulted in n = 1355 (84.9%) completed e-PROs (initial assessment: n = 355, monitoring: n = 967, final assessment: n = 44) and n = 242 (15.2%) non-completions. Instructions or support to complete e-PROs took on average 5.5 ± 5.3 min per patient contact. The most challenging issue was the integration of the results in clinical practice.ConclusionE-PRO assessment in oncologic inpatient settings is acceptable for patients and can support symptom identification and the initiation of supportive measures. The challenge of making the "data actionable" within the clinical workflow and motivating clinical staff to use the results became evident.

Project description:ObjectivesTo identify patient-reported outcome measures (PROMs) and patient-reported experience measures (PREMs) in clinical quality registries, for people with cutaneous melanoma, to inform a new Australian Melanoma Clinical Outcomes Registry; and describe opportunities and challenges of routine PROM/PREM collection, especially in primary care.DesignSystematic review.Primary and secondary outcome measuresWhich PROMs and PREMs are used in clinical quality registries for people with cutaneous melanoma, how they are collected, frequency of collection, participant recruitment methods and funding models for each registry.Results1134 studies were identified from MEDLINE, PreMEDLINE, Embase, PsychInfo, Cochrane Database of Abstracts of Reviews of Effects databases and TUFTS Cost-Effectiveness Analysis Registry, alongside grey literature, from database inception to 5th February 2020. Following screening, 14 studies were included, identifying four relevant registries: Dutch Melanoma Registry, Adelphi Real-World Disease-Specific Programme (Melanoma), Patient-Reported Outcomes Following Initial treatment and Long-term Evaluation of Survivorship Registry, and Cancer Experience Registry. These used seven PROMs: EuroQol-5 Dimensions, Functional Assessment of Cancer-General (FACT-G) and FACT-Melanoma (FACT-M), European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Cancer 30 (EORTC QLQ-C30), Fatigue Assessment Scale Hospital Anxiety and Depression Scale, Patient-Reported Outcome Measures Information System-29 and one PREM; EORTC QLQ-Information Module 26. PROMs/PREMs in registries were reported to improve transparency of care; facilitate clinical auditing for quality assessment; enable cost-effectiveness analyses and create large-scale research platforms. Challenges included resource burden for data entry and potential collection bias toward younger, more affluent respondents. Feedback from patients with melanoma highlighted the relevance of PROMs/PREMs in assessing patient outcomes and patient experiences.ConclusionsClinical registries indicate PROMs/PREMs for melanoma care can be incorporated and address important gaps, however cost and collection bias may limit generalisability.Prospero registration numberCRD42018086737.

Project description:The purpose of this study was to describe our experience with 1.0T MR-SIM including characterization, quality assurance (QA) program, and features necessary for treatment planning. Staffing, safety, and patient screening procedures were developed. Utilization of an external laser positioning system (ELPS) and MR-compatible couchtop were illustrated. Spatial and volumetric analyses were conducted between CT-SIM and MR-SIM using a stereotactic QA phantom with known landmarks and volumes. Magnetic field inhomogeneity was determined using phase difference analysis. System-related, in-plane distortion was evaluated and temporal changes were assessed. 3D distortion was characterized for regions of interest (ROIs) 5-20 cm away from isocenter. American College of Radiology (ACR) recommended tests and impact of ELPS on image quality were analyzed. Combined ultrashort echotime Dixon (UTE/Dixon) sequence was evaluated. Amplitude-triggered 4D MRI was implemented using a motion phantom (2-10 phases, ~ 2 cm excursion, 3-5 s periods) and a liver cancer patient. Duty cycle, acquisition time, and excursion were evaluated between maximum intensity projection (MIP) datasets. Less than 2% difference from expected was obtained between CT-SIM and MR-SIM volumes, with a mean distance of < 0.2 mm between landmarks. Magnetic field inhomogeneity was < 2 ppm. 2D distortion was < 2 mm over 28.6-33.6 mm of isocenter. Within 5 cm radius of isocenter, mean 3D geometric distortion was 0.59 ± 0.32 mm (maximum = 1.65 mm) and increased 10-15 cm from isocenter (mean = 1.57 ± 1.06 mm, maximum = 6.26 mm). ELPS interference was within the operating frequency of the scanner and was characterized by line patterns and a reduction in signal-to-noise ratio (4.6-12.6% for TE = 50-150 ms). Image quality checks were within ACR recommendations. UTE/Dixon sequences yielded detectability between bone and air. For 4D MRI, faster breathing periods had higher duty cycles than slow (50.4% (3 s) and 39.4% (5 s), p < 0.001) and ~fourfold acquisition time increase was measured for ten-phase versus two-phase. Superior-inferior object extent was underestimated 8% (6 mm) for two-phase as compared to ten-phase MIPs, although < 2% difference was obtained for ≥ 4 phases. 4D MRI for a patient demonstrated acceptable image quality in ~ 7 min. MR-SIM was integrated into our workflow and QA procedures were developed. Clinical applicability was demonstrated for 4D MRI and UTE imaging to support MR-SIM for single modality treatment planning.

Project description:BackgroundWith the rise of digital health technologies and telemedicine, the need for evidence-based evaluation is growing. Patient-reported outcome measures (PROMs) and patient-reported experience measures (PREMs) are recommended as an essential part of the evaluation of telemedicine. For the first time, a systematic review has been conducted to investigate the use of PROMs and PREMs in the evaluation studies of telemedicine covering all application types and medical purposes.ObjectiveThis study investigates the following research questions: in which scenarios are PROMs and PREMs collected for evaluation purposes, which PROM and PREM outcome domains have been covered and how often, which outcome measurement instruments have been used and how often, does the selection and quantity of PROMs and PREMs differ between study types and application types, and has the use of PROMs and PREMs changed over time.MethodsWe conducted a systematic literature search of the MEDLINE and Embase databases and included studies published from inception until April 2, 2020. We included studies evaluating telemedicine with patients as the main users; these studies reported PROMs and PREMs within randomized controlled trials, controlled trials, noncontrolled trials, and feasibility trials in English and German.ResultsOf the identified 2671 studies, 303 (11.34%) were included; of the 303 studies, 67 (22.1%) were feasibility studies, 70 (23.1%) were noncontrolled trials, 20 (6.6%) were controlled trials, and 146 (48.2%) were randomized controlled trials. Health-related quality of life (n=310; mean 1.02, SD 1.05), emotional function (n=244; mean 0.81, SD 1.18), and adherence (n=103; mean 0.34, SD 0.53) were the most frequently assessed outcome domains. Self-developed PROMs were used in 21.4% (65/303) of the studies, and self-developed PREMs were used in 22.3% (68/303). PROMs (n=884) were assessed more frequently than PREMs (n=234). As the evidence level of the studies increased, the number of PROMs also increased (τ=-0.45), and the number of PREMs decreased (τ=0.35). Since 2000, not only has the number of studies using PROMs and PREMs increased, but the level of evidence and the number of outcome measurement instruments used have also increased, with the number of PREMs permanently remaining at a lower level.ConclusionsThere have been increasingly more studies, particularly high-evidence studies, which use PROMs and PREMs to evaluate telemedicine. PROMs have been used more frequently than PREMs. With the increasing maturity stage of telemedicine applications and higher evidence level, the use of PROMs increased in line with the recommendations of evaluation guidelines. Health-related quality of life and emotional function were measured in almost all the studies. Simultaneously, health literacy as a precondition for using the application adequately, alongside proper training and guidance, has rarely been reported. Further efforts should be pursued to standardize PROM and PREM collection in evaluation studies of telemedicine.

Project description:PurposeOur purpose was to report outcomes of a novel palliative radiation therapy protocol that omits computed tomography simulation and prospectively collects electronic patient-reported outcomes (ePROs).Methods and materialsPatients receiving extracranial, nonstereotactic, linear accelerator-based palliative radiation therapy who met inclusion criteria (no mask-based immobilization and a diagnostic computed tomography within 4 weeks) were eligible. Global pain was scored with the 11-point numerical pain rating scale (NPRS). Patients were coded as having osseous or soft tissue metastases and no/mild versus severe baseline pain (NPRS ≥ 5). Pain response at 4 weeks was measured according to the international consensus (no analgesia adjustment). Transition to ePRO questionnaires was completed in 3 phases. Initially, pain assessments were collected on paper for 11 months, then pilot ePROs for 1 month and then, after adjustments, revised ePROs from 1 year onwards. ePRO feasibility criteria were established with reference to the paper-based process and published evidence.ResultsBetween May 2018 and November 2019, 542 consecutive patients were screened, of whom 163 were eligible (30%), and 160 patients were successfully treated. The proportion of patients eligible for the study improved from approximately 20% to 50% by study end. Routine care pain monitoring via ePROs was feasible. One hundred twenty-seven patients had a baseline NPRS recording. Ninety-five patients had osseous (61% severe pain) and 32 had soft tissue (25% severe pain) metastases. Eighty-four patients (66%) were assessable for pain response at 4 weeks. In the 41 patients with severe osseous pain, overall and complete pain response was 78% and 22%, respectively.ConclusionsBy study completion, 50% of patients receiving palliative extracranial radiation therapy avoided simulation, streamlining the treatment process and maximizing patient convenience. Pain response for patients with severe pain from osseous lesions was equivalent to published evidence.

Project description:PurposeIntegrating magnetic resonance (MR) into radiotherapy planning has several advantages. This report details the clinical implementation of an MR simulation (MR-planning) program for external beam radiotherapy (EBRT) in one of North America's largest radiotherapy programs.Methods and materialsAn MR radiotherapy planning program was developed and implemented at Sunnybrook Health Sciences Center in 2016 with two dedicated wide-bore MR platforms (1.5 and 3.0 Tesla). Planning MR was sequentially implemented every 3 months for separate treatment sites, including the central nervous system (CNS), gynecologic (GYN), head and neck (HN), genitourinary (GU), gastrointestinal (GI), breast, and brachial plexus. Essential protocols and processes were detailed in this report, including clinical workflow, optimized MR-image acquisition protocols, MR-adapted patient setup, strategies to overcome risks and challenges, and an MR-planning quality assurance program. This study retrospectively reviewed simulation site data for all MR-planning sessions performed for EBRT over the past 5 years.ResultsFrom July 2016 to December 2021, 8798 MR-planning sessions were carried out, which corresponds to 25% of all computer tomography (CT) simulations (CT-planning) performed during the same period at our institution. There was a progressive rise from 80 MR-planning sessions in 2016 to 1126 in 2017, 1492 in 2018, 1824 in 2019, 2040 in 2020, and 2236 in 2021. As a result, the relative number of planning MR/CT increased from 3% of all planning sessions in 2016 to 36% in 2021. The most common site of MR-planning was CNS (49%), HN (13%), GYN (12%), GU (12%), and others (8%).ConclusionDetailed clinical processes and protocols of our MR-planning program were presented, which have been improved over more than 5 years of robust experience. Strategies to overcome risks and challenges in the implementation process are highlighted. Our work provides details that can be used by institutions interested in implementing an MR-planning program.

Project description:ObjectivesTo evaluate the feasibility of a digital and continuous collection and reporting of patient-reported outcome measures (PROMs) and patient-reported experience measures (PREMs) for chronic heart failure (CHF).DesignA single-site pilot study was settled for evaluating the feasibility of the intervention, both using qualitative and quantitative data (ie, workshop, surveys).SettingThe pilot has been implemented in a Tuscan specialised hospital (Italy).Participants162 patients were involved. Inclusion criteria were: a previous diagnosis of HF, age ≥18 years, absence of cognitive impairment or active tumours, ability to provide informed consent to study participation.InterventionThe continuous collection and reporting of PROMs and PREMs has been designed and implemented in 2018. PREMs questionnaires for patients were developed, while Kansas City Cardiomyopathy Questionnaire-12 was used for assessing PROMs. Questionnaires are administered at specific time points: discharge; 30 days, 7 and 12 months after the discharge. Enrolment of patients, administration and real-time reporting of questionnaires are carried on through a digital platform.Outcome measuresEnrolment, response and drop-out rates were considered to assess the feasibility of the intervention. Qualitative data were collected during meetings and workshops with health workers. The representativeness of the recruited sample with respect to the population characteristics was also evaluated.ResultsThe system has been successfully implemented during 2018. Response rates have been consistently above 50%, demonstrating patients' transversal willingness to participate. All the involved stakeholders acknowledged the feasibility of the design. The recruited sample is significantly different in terms of age and educational level compared with the overall population characteristics.ConclusionIt is possible to run a web-based systematic collection and reporting system for CHF patient-reported data. Systematic collection and reporting of PROMs and PREMs data allows professionals to increasingly assume CHF patient perspective in their daily work. Limitations will be used to improve the system.

Dataset Information

Electronic Patient-Reported Outcome Measures in Radiation Oncology: Initial Experience After Workflow Implementation.

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Electronic Patient-Reported Outcome Measures in Radiation Oncology: Initial Experience After Workflow Implementation.

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