JMIR Publications

ABSTRACT

Background:

Over the past decades, academics, clinicians, and pharmaceutical companies have developed over 1,000 patient-reported outcome (PRO) measures to describe natural history, manage disease, and measure the effects of interventions in trials. Clinically, PROs can promote better care. Patients themselves increasingly use PROs online to track their progression, share their data, and even self-experiment. However, existing PROs often have limitations. They were originally designed for paper, not electronic screens; they are generally long and therefore burdensome; they are often negatively framed, forcing patients to focus on disease rather than aspire to better health; they may have onerous licensing restrictions; and they are either so generic as to miss key domains or so specific that patients with multiple conditions require multiple (often repetitive) instruments to reflect their true status.

Objective:

To develop and validate the core items of a modular, patient-centric, PRO system (“Thrive”) that could accurately, sensitively, and positively measure health status across a range of chronic conditions with minimal burden.

Methods:

Thrive was developed in four phases, largely consistent with Food and Drug Administration guidance regarding PRO development. First, preliminary core items (common across multiple conditions; “core Thrive items”) were developed through literature review, analysis of ~20 existing PROs on PatientsLikeMe, and feedback from psychometric and content experts. Second, two rounds of cognitive interviews were iteratively conducted with patients to obtain feedback on the preliminary items. Third, core Thrive items were administered electronically along with comparator measures (including SF-20 and PHQ-9) to a large sample (N=2002) of adults with chronic diseases through the PatientsLikeMe platform. Based on theoretical and empirical rationale, items were revised or removed. Fourth, the revised core Thrive items were administered to another sample of patients (N=704) with generic and condition-specific comparator measures. A psychometric evaluation, which included both modern and classical test theory approaches, was conducted on these items, and several more items were removed.

Results:

The finalized instrument consists of a 19-item core including five multi-item subscales; “Core symptoms”, “Abilities”, “Mobility”, “Sleep”, and “Thriving.” Results provide evidence of construct (content, convergent) validity, high levels of test-retest and internal consistency reliability, and ability to detect change over time. The items did not exhibit bias based on gender or age, and the items generally functioned similarly across conditions. These results support the use of Thrive Core items across diverse chronic patient populations.

Conclusions:

Thrive appears to be a useful approach for capturing important domains for patients with chronic conditions. This “core” set serves as a foundation to begin developing modular condition-specific versions in the near future. Cross-walking against traditional PROs from the PatientsLikeMe platform is underway, in addition to clinical validation and comparison with biomarkers. Thrive is licensed under Creative Commons Attribution Sharealike 4.0.