An exploratory pilot study to assess the feasibility of linking real world over-the-counter (OTC) analgesics use through consumer survey data to personal health record (PHR) data (My Medications and Medical Records (MyMMR))

Study identification

• EU PAS number:
  EUPAS50081
• Study ID:
  50082
• Official title and acronym:
  An exploratory pilot study to assess the feasibility of linking real world over-the-counter (OTC) analgesics use through consumer survey data to personal health record (PHR) data (My Medications and Medical Records (MyMMR))
• DARWIN EU® study:
  No
• Study countries:
  United States
• Study description:
  Capturing over-the-counter (OTC) medication use and health-related outcomes is historically difficult, limiting the ability to generate real-world evidence (RWE) about OTC products since data sources are scarce and disjointed. Recent US regulations regarding individuals’ access to their health records along with the broad adoption of smartphones and advances in digital technology hold promise to overcome these challenges. The intent of the pilot study is to determine the feasibility and scalability of using a mobile application (app)-based technology as a means to enable collection/assessments and integration of real world OTC medication usage information and patient reported outcomes (PROs) with health records data (PHR data). The pilot study will enroll a cohort of patients with ongoing acute or chronic (non-cancer) pain in order to serve as a proof-of-concept project to uncover insights into the feasibility of employing such technology across a diverse population. A key goal of the pilot will be to determine how best to capture these types of data in an unobtrusive manner to minimize burden on the study population and to determine the concordance of select PHR data captured via patient-mediation as compared to EHR data extraction via an integrated delivery network (IDN).
• Study status:
  Planned

Research institutions and networks

Institutions

Sutter Health

Study timelines

Date when funding contract was signed

Planned:01/11/2023

Actual:01/11/2022

Study start date

Planned:07/02/2023

Date of final study report

Planned:31/08/2023

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Johnson & Johnson, LLC

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable