scholarly journals Centralized patient-reported outcome data collection in transplantation is feasible and clinically meaningful

Cancer ◽  
2017 ◽  
Vol 123 (23) ◽  
pp. 4687-4700 ◽  
Author(s):  
Bronwen E. Shaw ◽  
Ruta Brazauskas ◽  
Heather R. Millard ◽  
Rachel Fonstad ◽  
Kathryn E. Flynn ◽  
...  
Keyword(s):  
Data Collection ◽  
Patient Reported Outcome ◽  
Outcome Data ◽  
Patient Reported ◽  
Outcome Data Collection

scholarly journals Building a National CML Registry

Blood ◽  
2019 ◽  
Vol 134 (Supplement_1) ◽  
pp. 3440-3440
Author(s):  
Ehab L. Atallah ◽  
Arun K Singavi ◽  
Bradley Taylor ◽  
Arielle Baim ◽  
Judith Myers ◽  
...  
Keyword(s):  
Side Effects ◽  
Data Collection ◽  
Clinical Data ◽  
Chart Review ◽  
Patient Reported Outcome ◽  
Outcome Data ◽  
Medical Monitoring ◽  
Patient Reported ◽  
Outcome Data Collection

Background: Tyrosine kinase inhibitor (TKI) therapy has led to phenomenal improvement in overall survival for patients with CML. Since TKI therapies were introduced and their results observed, very little innovative research has been conducted in CML. However, several important research directions remain, including, evaluating attempts to truly cure CML, i.e., patients off therapy with no detectable disease, evaluating long-term side effects and improving health related quality of life for patients who are unable to discontinue TKIs, and treatment of patients who are resistant to TKIs. Given that CML is a rare disease, this can only be achieved with considerable collaboration amongst CML experts. Such a collaboration is ongoing in the US NIH-funded Life After Stopping TKIs (LAST) study, which directly led to establishing the H. Jean Khoury Cure CML Consortium (HJKC3, named after a founding member, the late H. Jean Khoury, MD). One of the goals of the HJKC3 is to establish a national CML registry. A registry would collect longitudinal patient information to meet the critical need for both early and late outcomes research. A national CML registry is likely the only viable mechanism for identifying this population, enumerating baseline information, and addressing critical questions regarding late outcomes that may otherwise never be answered. This registry would also serve several other goals. The first aim of this registry is to prospectively collect and evaluate patient and physician compliance with recommended monitoring guidelines. The second goal is to collect data on survivorship. Some CML medications are associated with increased cardiovascular risk, nephrotoxicity, and pulmonary complications. Ensuring adequate medical monitoring of these long-term side effects and appropriately intervening is crucial to improve survival in patients with CML. The third goal is collecting patient reported outcome data directly from patients and linking that to compliance, complications, and clinical outcomes data. Lastly, this registry would inform potential clinical trials. Methods: After obtaining IRB approval, a pilot CML registry was developed at our institution with the goal of establishing the architecture for the infrastructure for a national CML registry. During this pilot we had two primary aims: first, to establish the most practical and efficient method for clinical data collection and second, to build and pilot test patient-reported outcome data collection. Retrospective clinical data was collected using REDCap with two primary mechanisms to populate the data into REDCap: 1) direct extraction and transfer of the data from the EHR and 2) manual chart review and data abstraction for complex fields or fields that require clinical interpretation. Broad categories of data that can be extracted from EMR include demographics, prior medical diagnosis, medications, some lab data, and prescription fill history. Examples of those requiring manual chart review include toxicity data, response, and disease progression data. For prospective chart review and patient-reported outcome data collection, informed consent was obtained electronically. Patient-reported outcomes assessments were administered online by emailing the study subjects a link to access a secure REDCap platform hosted by the MCW (CTSI) Clinical and Translational Science Institute. Measures include PROMIS computerized adaptive tests and select additional measures assessing a broad range of physical, emotional, cognitive, and social health domains. Progress: We identified 164 patients with CML to evaluate for inclusion. Of these, 72 (44%) were non-evaluable due to death, not an established patients, or other reasons and were included retrospectively only, while 92 (56%) were identified as potentially eligible for retrospective and prospective data collection. An invitation to join that included consent was sent to the 72 patients who had agreed to be contacted by email. Of those, 50 consented and 45 completed the baseline PROs, representing a 63% response rate. At 6 months, 39 completed the PRO assessment, representing an 87% retention rate. Data regarding human resource utilization are being collected to inform expected overall costs for a national registry. The next step is to expand to other sites in the HJKC3. Disclosures Atallah: Jazz: Consultancy; Helsinn: Consultancy; Jazz: Consultancy; Helsinn: Consultancy; Novartis: Consultancy; Takeda: Consultancy, Research Funding; Pfizer: Consultancy. Shaw:Therakos: Other: Speaker Engagement.

PatientConcept App � an innovative tool to improve therapy adherence and to implement risk management plans. (Preprint)

2018 ◽  
Author(s):  
Michael Lang ◽  
Martin Mayr ◽  
Stefan Ringbauer ◽  
Lukas Cepek
Keyword(s):  
Risk Management ◽  
Disease Management ◽  
Chronically Ill ◽  
Patient Reported Outcome ◽  
Outcome Data ◽  
Daily Routine ◽  
Software Application ◽  
Patient Reported ◽  
Management Plans ◽  
Chronically Ill Patients

UNSTRUCTURED Background: Adherence constitutes a great challenge for disease management, particularly when treating chronically ill patients facing an extensive, complex and long-term therapy. Earlier studies emphasize the relevance of adherence for improving therapy benefits. Besides the positive impact of increased patient support, the use of mobile health applications has gained importance in disease management. Objective: We aimed to develop a software application providing innovative features to simplify the contact between patients and treating physicians in order to overcome adherence barriers, to implement risk management plans and to collect patient reported outcome data. Methods: A novel software application ensuring data security was developed. Various innovative modules have been implemented, enabling bidirectional communication between treating physicians and patients, supporting therapy monitoring and management and allowing the collection of large sets of anonymous patient data. Results: The PatientConcept app is freely available for download and is tested since 2016, with more than 1800 generated patient IDs and 279 patients documenting health data according to risk management plans online in 2017. The impact on adherence issues is currently tested in larger patient populations. Conclusion: This innovative app provides a feasible and cost-optimized possibility to intensify and simplify the communication between patients and their treating physicians across indications, thus promising an exceptional benefit to both. It may not only support chronically ill patients in managing their daily life and improving adherence, but can also facilitate the implementation of risk management plans through automated monitoring, thus supporting physicians in their daily routine. Furthermore, patient reported outcome data can be collected. Importantly, a secure ID-associated data management ensures patient anonymity complying with highest data safety standards.

Health-related quality-of-life (HRQoL) analysis from a randomized phase II trial of androgen signaling inhibitors with or without androgen deprivation therapy (ADT) for castration-sensitive prostate cancer: LACOG 0415.

2021 ◽  
Vol 39 (6_suppl) ◽  
pp. 64-64
Author(s):  
Andrey Soares ◽  
Diogo Assed Bastos ◽  
Fabio A. B. Schutz ◽  
Eduardo Cronemberger ◽  
Murilo Luz ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Locally Advanced ◽  
Patient Reported Outcome ◽  
Abiraterone Acetate ◽  
Outcome Data ◽  
Rank Test ◽  
Emotional Wellbeing ◽  
Patient Reported ◽  
Related Quality

64 Background: LACOG0415 is a 3-arm randomized trial evaluating ADT with abiraterone acetate plus prednisone (ADT+AAP), apalutamide alone (APA) or apalutamide with AAP (APA+AAP) for patients with locally-advanced, high-risk biochemical recurrence or metastatic castration-sensitive prostate cancer (ASCO 2020). In this trial, ADT+AAP and APA+AAP achieved the primary endpoint of percentage of patients with PSA ≤ 0.2 ng/mL at week 25. Apalutamide alone showed a high PSA decline > 50% rate, but did not achieve the pre-specified PSA threshold. Here we report patient-reported outcome data using Functional Assessment of Cancer Therapy-Prostate (FACT-P). Methods: HRQoL was measured in the overall population using the FACT-P questionnaire, comprising 5 subscales: physical wellbeing (PWB), functional wellbeing (FWB), emotional wellbeing (EWB), social/family wellbeing (SFWB), and prostate cancer subscale (PCS). Scores for each patient were measured at baseline and every four weeks until week 25. Questionnaire completion was defined as ≥ 1 question answered at an assessment time point. Analysis of HRQoL change from baseline and deterioration included only patients with baseline and ≥ 1 postbaseline score. Differences greater than 10-points in FACT-P total score and differences greater than 3-points in PWB, FWB, EWB, SFWB, and PCS scores were considered clinically significant. The time-to-event endpoint was estimated by Kaplan-Meier method and compared by stratified log-rank test. Results: 128 patients were included in LACOG0415 trial and 122 of them completed the HRQoL assessments (ranging from 95.3% at baseline to 79.7% at week 25). FACT-P and all subscales scores were similar for all three arms at baseline. There were no meaningful differences in FACT-P scores at baseline and at week 25 between the 3 arms. The subscales scores also showed no statistically differences at baseline and at week 25. Time to FACT-P deterioration did not show any statistically difference between three arms ( P=0.3371). Conclusions: ADT free alternatives with APA alone or APA+AAP did not show meaningful differences in HRQoL in patients with advanced castration-sensitive prostate cancer compared to ADT+AAP. The short follow-up period limited the ability to explore differences in HRQoL after 25 weeks. Larger studies with longer follow-up are needed to further evaluate HRQoL with ADT-free strategies. Clinical trial information: NCT02867020. [Table: see text]

Analyzing patient‐reported outcome data when completion differs between arms in open‐label trials: an application of principal stratification

2019 ◽  
Vol 28 (10) ◽  
pp. 1386-1394 ◽  
Author(s):  
Jessica K. Roydhouse ◽  
Roee Gutman ◽  
Vishal Bhatnagar ◽  
Paul G. Kluetz ◽  
Rajeshwari Sridhara ◽  
...  
Keyword(s):  
Patient Reported Outcome ◽  
Outcome Data ◽  
Principal Stratification ◽  
Open Label ◽  
Patient Reported
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