August 28, 2018: ADAPTABLE Patient-Reported Health Data Codes Now Available

The ADAPTABLE pragmatic trial relies on patients to report key information at baseline and throughout follow-up. To capture these data, ADAPTABLE investigators developed a LOINC (Logical Observation Identifiers Names and Codes) patient-reported item set, which is now publicly available.

The development of the item set is part of the ADAPTABLE Supplement, an initiative funded by the Office of the Assistant Secretary for Planning and Evaluation to develop best practices for capturing patient-reported outcome data and optimal analytic approaches for using the data in a pragmatic clinical trial. Additional reference material can be found in the ADAPTABLE Supplement Roundtable Meeting summary, in a report describing the results of a literature review of data standards and metadata standards for variables of interest, and on GitHub. The project is expected to inform future efforts to integrate patient-reported data in the electronic health record and provide opportunities to streamline data for use in pragmatic trials. Information from the project is being added to the Living Textbook as it accumulates; learn more in the chapters on Using Electronic Health Record Data and Choosing and Specifying End Points and Outcomes.

ADAPTABLE (Aspirin Dosing: A Patient-Centric Trial Assessing Benefits and Long-Term Effectiveness) aims to identify the optimal dose of aspirin therapy for secondary prevention in atherosclerotic cardiovascular disease and is the first major randomized comparative effectiveness trial to be conducted by the National Patient-Centered Clinical Research Network (PCORnet).

March 14, 2018: Public Input on Patient-Reported Outcome Measures Due April 1

The Agency for Healthcare Research and Quality (AHRQ) is requesting information to help inform a competition in the fall to develop and implement user-friendly technical tools for the collection of patient-reported outcome (PRO) data. The AHRQ is interested in learning about experiences with physical function PRO measures that are currently in use in ambulatory care settings, including primary and secondary care, as well as the methods used to collect these data. The information will be used to select physical function measures for the competition, which aims to bolster collection and integration of PRO data in the electronic health record by developing and piloting new, user-friendly tools. Responses can be emailed to Janey.hsiao@ahrq.hhs.gov and are due April 1, 2018.

New White Paper from Collaboratory PRO Core on the Impact of Patient-Reported Outcomes on Clinical Practice

Patient-reported outcome (PRO) measures are often used in pragmatic clinical trials to assess endpoints that are meaningful to stakeholders. These measures may also support patient care, although there is mixed evidence about effects of PROs on (1) improved patient-provider communication, clinical decision-making, and patient satisfaction; (2) enhanced patient outcomes; and (3) helped ensure better quality of care from a healthcare systems perspective. In a new white paper from the Collaboratory Patient-Reported Outcomes Core, the available evidence in the literature is examined to determine when PROs have the potential to provide added value to patient care.

The full text of the white paper can be found here: Impact of Patient-Reported Outcomes on Clinical Practice_V1.0

Study Shows Patient-Reported Outcomes Valid & Reliable for Adverse Events of Cancer Treatment


In a study recently published in JAMA Oncology, researchers found that patient reporting of adverse events of cancer treatment using a new scale gave valid and reliable assessments that correlated with standard measures of functioning and quality of life. The National Cancer Institute (NCI) developed a patient-reported outcome (PRO) version of its Common Terminology Criteria for Adverse Events (CTCAE), which is the standard system for reporting toxicities of cancer treatment in clinical trials. The PRO-CTCAE was then tested among more than 900 patients undergoing treatment at 9 cancer centers. As described in a commentary by Benjamin Movsas, MD, these results are encouraging for PROs to be integrated in informing treatment recommendations, symptom management, and even labeling decisions.

Read more about PROs in the Living Textbook chapter on this topic.


Computer Adaptive Testing Approach to Patient-Reported Outcomes


Michael Bass and Maria Varela Diaz of the Department of Social Sciences, Feinberg School of Medicine, Northwestern University, have kindly given the Living Textbook permission to post their presentation (link opens as a PDF) about how to use an application programming interface (API) to create a computer adaptive testing (CAT) program that integrates patient-reported outcome (PRO) measures with an institution’s electronic health record (EHR) system.

With a CAT approach, PRO assessment can cover a wide range of question/response items with increased precision. In their CAT application, the authors describe a clinical use case for a mobile health solution, using measures from the NIH-sponsored PRO Measurement Information System (PROMIS®) domain framework, in which a health assessment is issued by a physician, administered to a patient via phone, and then sent back to the EHR.

You can read more about CAT in the Patient-Reported Outcomes chapter of the Living Textbook.