Home ePRO compliance in prostate cancer clinical studies.

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. 2063-2063
Author(s):  
Sarah Tressel Gary ◽  
Nadeeka Dias ◽  
Elisa Conrad ◽  
Kenneth G Faulkner
Keyword(s):  
Prostate Cancer ◽  
Clinical Studies ◽  
Daily Diary ◽  
Clinic Visit ◽  
Lower Number ◽  
Quality Data ◽  
Assessment Period ◽  
Patient Reported ◽  
Clinic Visits ◽  
At Home

2063 Background: Patient-reported outcomes (PRO) and electronic PRO (ePRO) play an important role in the development and approval of cancer products. Regulatory agencies are encouraging the inclusion of PRO-based endpoints that are indicative of clinical benefit in terms of patient symptoms and overall quality of life (QOL). Compliance with completion of ePRO assessments is an important component for obtaining accurate and high-quality data when conducting clinical trials. Traditionally, ePRO data in oncology trials has been collected mainly at clinic visits due to concerns over poor compliance at home. However, since symptoms and QOL can vary widely through a treatment course, it is often necessary to collect ePRO data more frequently in between clinic visits. It has been hypothesized that home completion, length of time in a study, and number of assessments may affect compliance. Methods: To address this hypothesis, ePRO compliance data was analyzed from two clinical studies in prostate cancer. Both studies used a handheld smartphone that contained an application to collect ePRO data. At the randomization visit, subjects completed ePRO assessments in clinic (2-3 questionnaires). Subsequently, all assessments were completed at home, including a daily diary and 1-4 questionnaires completed every 4-8 weeks for up to 14 months. Compliance was calculated as the number of assessments received divided by the number of assessments expected in a given assessment period. To evaluate assessment burden, each assessment period was categorized as requiring a lower number (daily diary and 1 questionnaire) or higher number (daily diary and 2-4 questionnaires) of assessments. Results: A total of 1,040 patients were included in the analysis. Overall compliance at the single clinic visit was 100%, which was expected since it was a required randomization visit. Overall compliance at home over 14 months was 80%. Compliance ranged from 78% to 89% over the duration of the studies, with no effect of time in the study on compliance. Compliance remained high even as patient numbers declined. Compliance when patients were required to complete a lower number of assessments (80%) was similar to compliance when patients were required to complete a higher number of assessments (79%). Compliance by region varied from 72% (Middle East) to 87% (Asia and Eastern Europe). Conclusions: The collection of ePRO at home provided high compliance that did not vary with length of time in the study or due to assessment burden. At home ePRO assessments provide an effective and feasible approach for recording symptoms and QOL in prostate cancer patients.

Compliance of subjects using electronic patient-reported outcomes (ePRO) in multinational prostate trials.

2014 ◽  
Vol 32 (4_suppl) ◽  
pp. 232-232
Author(s):  
Susan M. Dallabrida
Keyword(s):  
Quality Of Life ◽  
Prostate Cancer ◽  
Clinical Trials ◽  
Patient Reported Outcomes ◽  
Short Form ◽  
Quality Data ◽  
Data Set ◽  
Patient Reported ◽  
Clinic Visits

232 Background: Patient Reported Outcomes (PRO) and electronic PRO (ePRO) are increasingly becoming an important aspect of cancer clinical trials and patient care, especially with regard to measuring drug efficacy, patient quality of life and drug safety. Subject compliance with completion of PRO/ePRO assessments is an important component for obtaining accurate and high-quality data when conducting clinical trials. It has been hypothesized that patient health status, length of time in a trial and country of origin, may affect compliance. Methods: To address this hypothesis, an operational analysis was conducted to assess oncology subject completion compliance of PRO reports using an electronic tablet to determine its suitability and performance in use. Toward this objective, the compliance of prostate cancer patients in completing three electronic questionnaires that were administered at clinic visits was evaluated. Subjects were asked to complete the Brief Pain Inventory – Short Form (BPI-SF) at every clinic visit. At some clinic visits, subjects were asked to additionally complete the Functional Assessment of Cancer Therapy – Prostate (FACT-P) and the Euro Quality of Life 5 Dimensions (EQ-5D). Questionnaires were completed electronically on the tablet. Percent completion was calculated as the number of questionnaires completed divided by the number of questionnaires expected, based on attended clinic visits compiled for this review and the administration schedule for the questionnaires. Results: This review draws on the experience of over 1,000 subjects from 21 countries, and describes the individual and overall compliance with the expected questionnaire completion, the variance between subsequent visits, and compliance by country. Conclusions: The collection of ePRO using a clinic-based tablet yielded a highly complete data set in prostate cancer subjects demonstrating that this is an effective and feasible approach for recording symptoms and quality of life assessments.

scholarly journals Enhancing Patient-Provider Communication With the Electronic Self-Report Assessment for Cancer: A Randomized Trial

2011 ◽  
Vol 29 (8) ◽  
pp. 1029-1035 ◽  
Author(s):  
Donna L. Berry ◽  
Brent A. Blumenstein ◽  
Barbara Halpenny ◽  
Seth Wolpin ◽  
Jesse R. Fann ◽  
...  
Keyword(s):  
Controlled Trial ◽  
Clinic Visit ◽  
Self Report ◽  
Comprehensive Cancer Center ◽  
Cancer Center ◽  
Control Group ◽  
Cancer Symptoms ◽  
Patient Reported ◽  
Life Issues ◽  
Clinic Visits

Purpose Although patient-reported cancer symptoms and quality-of-life issues (SQLIs) have been promoted as essential to a comprehensive assessment, efficient and efficacious methods have not been widely tested in clinical settings. The purpose of this trial was to determine the effect of the Electronic Self-Report Assessment–Cancer (ESRA-C) on the likelihood of SQLIs discussed between clinicians and patients with cancer in ambulatory clinic visits. Secondary objectives included comparison of visit duration between groups and usefulness of the ESRA-C as reported by clinicians. Patients and Methods This randomized controlled trial was conducted in 660 patients with various cancer diagnoses and stages at two institutions of a comprehensive cancer center. Patient-reported SQLIs were automatically displayed on a graphical summary and provided to the clinical team before an on-treatment visit (n = 327); in the control group, no summary was provided (n = 333). SQLIs were scored for level of severity or distress. One on-treatment clinic visit was audio recorded for each participant and then scored for discussion of each SQLI. We hypothesized that problematic SQLIs would be discussed more often when the intervention was delivered to the clinicians. Results The likelihood of SQLIs being discussed differed by randomized group and depended on whether an SQLI was first reported as problematic (P = .032). Clinic visits were similar with regard to duration between groups, and clinicians reported the summary as useful. Conclusion The ESRA-C is the first electronic self-report application to increase discussion of SQLIs in a US randomized clinical trial.

scholarly journals Precision Assessment of COVID-19 Phenotypes Using Large-Scale Clinic Visit Audio Recordings: Harnessing the Power of Patient Voice

10.2196/20545 ◽  
2021 ◽  
Vol 23 (2) ◽  
pp. e20545
Author(s):  
Paul J Barr ◽  
James Ryan ◽  
Nicholas C Jacobson
Keyword(s):  
Machine Learning ◽  
High Risk ◽  
Language Processing ◽  
Large Scale ◽  
Clinical Symptoms ◽  
Clinical Phenotype ◽  
Clinic Visit ◽  
Patient Reported ◽  
Audio Recordings ◽  
Clinic Visits

COVID-19 cases are exponentially increasing worldwide; however, its clinical phenotype remains unclear. Natural language processing (NLP) and machine learning approaches may yield key methods to rapidly identify individuals at a high risk of COVID-19 and to understand key symptoms upon clinical manifestation and presentation. Data on such symptoms may not be accurately synthesized into patient records owing to the pressing need to treat patients in overburdened health care settings. In this scenario, clinicians may focus on documenting widely reported symptoms that indicate a confirmed diagnosis of COVID-19, albeit at the expense of infrequently reported symptoms. While NLP solutions can play a key role in generating clinical phenotypes of COVID-19, they are limited by the resulting limitations in data from electronic health records (EHRs). A comprehensive record of clinic visits is required—audio recordings may be the answer. A recording of clinic visits represents a more comprehensive record of patient-reported symptoms. If done at scale, a combination of data from the EHR and recordings of clinic visits can be used to power NLP and machine learning models, thus rapidly generating a clinical phenotype of COVID-19. We propose the generation of a pipeline extending from audio or video recordings of clinic visits to establish a model that factors in clinical symptoms and predict COVID-19 incidence. With vast amounts of available data, we believe that a prediction model can be rapidly developed to promote the accurate screening of individuals at a high risk of COVID-19 and to identify patient characteristics that predict a greater risk of a more severe infection. If clinical encounters are recorded and our NLP model is adequately refined, benchtop virologic findings would be better informed. While clinic visit recordings are not the panacea for this pandemic, they are a low-cost option with many potential benefits, which have recently begun to be explored.

Abstract 15897: Patient Experience With Telemedicine in Adults With Congenital Heart Disease

Circulation ◽  
2020 ◽  
Vol 142 (Suppl_3) ◽  
Author(s):  
Anudeep Dodeja ◽  
Matt Granger ◽  
Deboarah Mitchell ◽  
Rosemary Chumita ◽  
tracey sisk ◽  
...  
Keyword(s):  
Congenital Heart Disease ◽  
Heart Disease ◽  
Patient Experience ◽  
Congenital Heart ◽  
Healthcare Delivery ◽  
Clinic Visit ◽  
Healthcare Research ◽  
Healthcare Needs ◽  
Patient Reported ◽  
Clinic Visits

Introduction: COVID19 pandemic has resulted in drastic changes in healthcare delivery with increase in use of telemedicine. There is limited data on patient experience with telemedicine in adults with congenital heart disease (ACHD). Hypothesis: We hypothesized that ACHD patients would prefer in-person clinic visits over telemedicine, and this would be especially true for patients > 65 years who may be at a higher risk of experiencing technical limitations. Methods: We conducted a nurse administered telephone survey (Figure 1A) based on Agency for Healthcare Research and Quality recommendations to assess patient experience after ACHD telemedicine visits from March 2020 to June 2020. Results: Of 216 patients who had ACHD telemedicine visits, 136 (63%) agreed to participate in the survey. Mean age was 45 + 18 years, majority (65%) being video encounters. Most (98%) said that the telemedicine visit was successful in addressing their healthcare needs. Only 21 (15%) patients reported technical issues. Most patients (76%) were likely to choose telemedicine in the future instead of an in-person clinic visit provided testing was done separately. Given a choice between in-person clinic visit and telemedicine: 103 (76%) preferred telemedicine, 25 (18%) preferred in-person clinic visits, and 8 (6%) had no preference (Figure1B). Of the 25 patients over 65 years, 19 (76%) would choose telemedicine over the in-person clinic, and only one patient reported technical difficulties. Conclusion: In conclusion, patients reported a positive experience with ACHD telemedicine, which was true even among elderly patients. Technical limitations were infrequent even amongst the elderly. Majority of patients felt that their healthcare needs were addressed and would consider telemedicine over clinic visits if given a choice. This data is vital as payors move away from supporting telemedicine and hospitals restructure, with and without ongoing COVID 19 concerns.

Confirmatory Psychometric Evaluation of the Axillary Sweating Daily Diary: A Vaildated Patient-Reported Outcome Measure to Assess Axillary Hyperhidrosis Sweating Severity

2017 ◽  
Vol 1 ◽  
pp. s94 ◽  
Author(s):  
Dee Anna Glaser ◽  
Adelaide A Hebert ◽  
Sheri Fehnel ◽  
Dana DiBenedetti ◽  
Lauren Nelson ◽  
...  
Keyword(s):  
Outcome Measure ◽  
Daily Diary ◽  
Psychometric Evaluation ◽  
Patient Reported Outcome ◽  
Axillary Hyperhidrosis ◽  
Patient Reported Outcome Measure ◽  
Patient Reported

Abstract Not AvailableDisclosure: Study supported by Dermira.

scholarly journals Measuring What Matters for Children: A Systematic Review of Frequently Used Pediatric Generic PRO Instruments

2021 ◽  
Author(s):  
Tasneem Arsiwala ◽  
Nuzhat Afroz ◽  
Kattayoun Kordy ◽  
Christel Naujoks ◽  
Francesco Patalano
Keyword(s):  
Quality Of Life ◽  
Child Health ◽  
Clinical Studies ◽  
Task Force ◽  
Emotional Health ◽  
Research Practices ◽  
European Collaboration ◽  
Patient Reported ◽  
Good Research

Abstract Objective To provide an assessment of the quality of the most frequently used self-reported, generic patient-reported outcome measures (PROMs) that measure health-related quality of life (HRQoL) in children against the good research practices recommended by ISPOR task force for the pediatric population. Method Literature search was conducted on OvidSP database to identify the generic pediatric PROMs used in published clinical studies. The quality of PROMs used in more than ten clinical studies were descriptively evaluated against the ISPOR task force’s good research practices. Results Six PROMs were evaluated, namely Pediatric Quality-of-Life inventory 4.0 (PedsQL), Child Health Questionnaire (CHQ), KIDSCREEN, KINDL, DISABKIDS and Child Health and Illness Profile (CHIP). All PROMs, except KIDSCREEN, had versions for different age ranges. Domains of physical, social, emotional health and school activities were common across all the instruments, while domains of family activities, parent relations, independence, and self-esteem were not present in all. Children’s input was sought during the development process of PROMs. Likert scales were used in all the instruments, supplemented with faces (smileys) in instruments for children under 8 years. KIDSCREEN and DISABKIDS were developed in a European collaboration project considering the cross-cultural impact during development. Conclusion The comparison of the instruments highlights differences in the versions for different pediatric age groups. None of the PROMs fulfill all the good research practices recommended by the ISPOR task force. Further research is needed to define which age-appropriate domains are important for older children and adolescents.

scholarly journals 581 The Effects of the COVID Pandemic on Burn Clinic

2021 ◽  
Vol 42 (Supplement_1) ◽  
pp. S142-S142
Author(s):  
Theresa L Chin ◽  
Rita Frerk ◽  
Victor C Joe ◽  
Sara Sabeti ◽  
Kimberly Burton ◽  
...  
Keyword(s):  
Burn Injury ◽  
Univariate Analysis ◽  
Medical Facility ◽  
Burn Care ◽  
Appointment Date ◽  
Encrypted Communication ◽  
Time Of Presentation ◽  
Staying At Home ◽  
Clinic Visits ◽  
At Home

Abstract Introduction The COVID19 pandemic has led to anxiety and fears for the general public. People were concerned about coming to a medical facility where the virus might be transmitted. Furthermore, stay-at-home orders that were implemented during the pandemic did not apply to clinic visits but contributed to people staying at home even for medical care. We hypothesized that there were delays in burn care due to the pandemic. Methods We queried our clinic data for number of clinic visits and new burn evaluations by month. Patients referred to our clinic from March 15, 2020 to Sept 15, 2020 were reviewed for time of presentation after injury. Days from injury date to clinic referral date and days from clinic referral date to appointment date were calculated. Patients who were referred but did not show and were not seen in our ED were not included because injury date could not be determined. Univariate analysis was performed. Results As seen in Figure 1, our in-person clinic volume decreased in April and May 2020 but rebounded in June 2020 as compared to the number of clinic visits for the same months last year. Similarly, in Figure 2, our new burn evaluations decreased in April and May 2020 compared to our new burn volume from 2019. However, our video telehealth visits increased in March and April then decreased in June-August. Conclusions Our burn clinic remained open to see patients with burn injury throughout the pandemic, however, clinic visits were delayed early in the pandemic. While we had an increase in video telehealth, it does not account for the decrease in clinic visits. This may be due to low enrollment in the electronic medical record encrypted communication platform and/or limited knowledge/access to the technology. Additional care may have been informally given via telephone but not well captured. Furthermore, burn care was delivered in the following months. Additional investigation is necessary to see if the incidence of burn injury decreased.

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