scholarly journals Patient Reported Outcomes: Listening for What is Most Important in Clinical Care and Patient‐focused Drug Development

2021 ◽  
Author(s):  
Barbara Ameer
Keyword(s):  
Drug Development ◽  
Patient Reported Outcomes ◽  
Clinical Care ◽  
Patient Reported ◽  
Patient Focused Drug Development

scholarly journals Patient-reported outcomes in drug development for hematology

Hematology ◽  
2015 ◽  
Vol 2015 (1) ◽  
pp. 496-500 ◽  
Author(s):  
Catherine Acquadro ◽  
Antoine Regnault
Keyword(s):  
Clinical Trials ◽  
Drug Development ◽  
Patient Reported Outcomes ◽  
Clinical Decision Making ◽  
Well Being ◽  
New Drugs ◽  
Specific Situation ◽  
Treatment Benefit ◽  
Hematologic Diseases ◽  
Patient Reported

Abstract Patient-reported outcomes (PROs) are any outcome evaluated directly by the patient himself and based on the patient's perception of a disease and its treatment(s). PROs are direct outcome measures that can be used as clinical meaningful endpoints to characterize treatment benefit. They provide unique and important information about the effect of treatment from a patient's view. However, PROs will only be considered adequate if the assessment is well-defined and reliable. In 2009, the FDA has issued a guidance, which defines good measurement principles to consider for PRO measures intended to give evidence of treatment benefit in drug development. In hematologic clinical trials, when applied rigorously, they may be used to evaluate overall treatment effectiveness, treatment toxicity, and quality of patient's well-being at short-term and long-term after treatment from a patient's perspective. In situations in which multiple treatment options exist with similar survival outcome or if a new therapeutic strategy needs to be evaluated, the inclusion of PROs as an endpoint can provide additional data and help in clinical decision making. Given the diversity of the hematological field, the approach to measurement needs to be tailored for each specific situation. The importance of PROs in hematologic diseases has been highlighted in a number of international recommendations. In addition, new perspectives in the regulatory field will enhance the inclusion of PRO endpoints in clinical trials in hematology, allowing the voice of the patients with hematologic diseases to be taken into greater consideration in the development of new drugs.

scholarly journals Benefits of patient-reported outcomes in Dermatology Drug Development

2015 ◽  
Vol 18 (3) ◽  
pp. A184 ◽  
Author(s):  
C. Copleymerriman ◽  
S. Zelt ◽  
M. Clark ◽  
A. Gnanasakthy
Keyword(s):  
Drug Development ◽  
Patient Reported Outcomes ◽  
Patient Reported

The Use of Patient-reported Outcomes at an Individual Level – Benefits and Challenges

2010 ◽  
Vol 06 (01) ◽  
pp. 19
Author(s):  
Agnes Czimbalmos ◽  
Andrew Bottomley ◽  
◽  
Keyword(s):  
Patient Reported Outcomes ◽  
Clinical Care ◽  
Healthcare Services ◽  
Individual Level ◽  
Patient Health Status ◽  
Hrqol Data ◽  
Patient Reported ◽  
Patient Health ◽  
Related Quality ◽  
Health Related

The aim of this article is to review the application of patient-reported outcomes (PROs) in clinical care and consider its benefits, challenges and potential improvements. Previous studies demonstrated that health-related quality of life (HRQoL) data provide information to clinicians on patient health status, QoL, symptoms and wellbeing, along with any changes in these, and helps clinicians judge the needs of patients and tailor treatments accordingly. In addition, the benefits of the application of HRQoL tools include the involvement of patients in informed decision-making in terms of their treatment or care, higher patient satisfaction with healthcare services, improved patient–clinician relationships and better communication. In many studies, health professionals have expressed their interest in using these measures but feel they need to better understand them. Despite the wide use of information-gathering questionnaires and their promising results, it is still a challenge to predict the full value of these measures in clinical care. This article addresses these major concerns.

Untangling a web of Electronic Patient Reported Outcomes data to support quality improvement.

2019 ◽  
Vol 37 (27_suppl) ◽  
pp. 311-311
Author(s):  
Meggan Davis ◽  
Erik Winters ◽  
Lisa Acomb ◽  
Matt Palmgren ◽  
Kerry K McMillen ◽  
...  
Keyword(s):  
Patient Reported Outcomes ◽  
Clinical Care ◽  
Program Improvement ◽  
Project Team ◽  
Distress Screening ◽  
Response Distribution ◽  
Data Infrastructure ◽  
Patient Reported ◽  
Volume Response ◽  
Data Tables

311 Background: Adoption of Electronic Patient Reported Outcomes (ePROs) as part of clinical care is aided by the ability to respond to feedback and develop solutions founded on data. This requires access to usage, volume, response, and system performance data, yet with limited resources the infrastructure needed to store and analyze these data is often an afterthought. The Seattle Caner Care Alliance followed an iterative process to create dashboards featuring content-specific metrics while improving the underlying infrastructure of patient-generated data collected via the ePRO program. Methods: For each dashboard, the project team followed 7 steps: 1) Clarify the purpose. 2) Brainstorm requirements with content-specific stakeholders. 3) Create initial drafts for review, testing, and validation. 4) Validate that metrics are clear and provide value. 5) Update dashboards and review with stakeholders. 6) Perform technical clean-up and improvement to data infrastructure. 7) Iterate until all stakeholders approve. Results: 27 data tables were linked to create four content-specific dashboards: Overall Key Performance Indicators (KPI), an experimental dashboard, and responses to chemotherapy symptom and distress screening surveys. The KPI dashboard featured completion rate, adoption rate, survey and intervention volumes with the ability to filter by ePRO type, diagnosis, and intervention. The experimental dashboard allowed the project team to test data points, visualizations and methodologies before creating dashboards or updating data structures. Chemotherapy symptom and distress screening dashboards displayed interventions by symptom or concern, severity, referrals, and response distribution. Conclusions: Data collected via an ePRO program offers an opportunity for improvement during implementation and ongoing program development. An iterative approach to analyzing these data and creating dashboards that engaged stakeholders and focused on data quality was an effective way to untangle a complex web of patient-generated data and to support program improvement. Future ePRO implementation would benefit from the inclusion of a flexible data development approach as part of planning and design.

scholarly journals Patient-reported outcomes in clinical practice

Hematology ◽  
2015 ◽  
Vol 2015 (1) ◽  
pp. 501-506 ◽  
Author(s):  
Sarah Dobrozsi ◽  
Julie Panepinto
Keyword(s):  
Clinical Practice ◽  
Patient Outcomes ◽  
Patient Reported Outcomes ◽  
Clinical Care ◽  
Patient Reported Outcome ◽  
Physician Communication ◽  
Valuable Data ◽  
Patient Reported ◽  
Improve Patient

Abstract Patient-reported outcome (PRO) measurement plays an increasingly important role in health care and understanding health outcomes. PROs are any report of a patient's health status that comes directly from the patient, and can measure patient symptoms, patient function, and quality-of-life. PROs have been used successfully to assess impairment in a clinical setting. Use of PROs to systematically quantify the patient experience provides valuable data to assist with clinical care; however, initiating use of PROs in clinical practice can be daunting. Here we provide suggestions for implementation of PROs and examples of opportunities to use PROs to tailor individual patient therapy to improve patient outcomes, patient–physician communication, and the quality of care for hematology/oncology patients.

scholarly journals Research methodology for orthopaedic surgeons, with a focus on outcome

2018 ◽  
Vol 3 (5) ◽  
pp. 160-167 ◽  
Author(s):  
Anne Lübbeke
Keyword(s):  
Public Health ◽  
Research Methodology ◽  
Patient Reported Outcomes ◽  
Conceptual Models ◽  
Clinical Care ◽  
Clinically Important Difference ◽  
Key Points ◽  
Significant Difference ◽  
Patient Reported ◽  
Different Types

Since improving the patient’s condition is the ultimate goal of clinical care and research, this review of research methodology focuses on outcomes in the musculoskeletal field. This paper provides an overview of conceptual models, different types of outcomes and commonly assessed outcomes in orthopaedics as well as epidemiological and statistical aspects of outcomes determination, measurement and interpretation. Clinicians should determine the outcome(s) most important to patients and/or public health in collaboration with the patients, epidemiologists/statisticians and other stakeholders. Key points in outcome choice are to evaluate both the benefit and harm of a health intervention, and to consider short- and longer-term outcomes including patient-reported outcomes. Outcome estimation should aim at identifying a clinically important difference (not the same as a statistically significant difference), at presenting measures of effects with confidence intervals and at taking the necessary steps to minimize bias. Cite this article: EFORT Open Rev 2018;3 DOI: 10.1302/2058-5241.3.170064

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