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 type

• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness

  Disease epidemiology

  Drug utilisation

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Medical condition to be studied:
  Pain

Population studied

• Age groups:
  • Adults (18 to < 46 years)
  • Adults (46 to < 65 years)
  • Adults (65 to < 75 years)
  • Adults (75 to < 85 years)
  • Adults (85 years and over)
• Estimated number of subjects:
  100

Study design details

• Main study objective:
  Participant usability of the mobile app within the context of the pilot study
• Outcomes:
  Concordance between patient-mediated PHR data and EHR-extracted data, Willingness to participate in the pilot study and its procedures for data collection Distribution of entry methods (portal import, pick-list, NDC, or free-text) for medications
• Data analysis plan:
  All study variables will be summarized descriptively. Summary statistics for continuous variables include number of observations, mean, standard deviation, median, minimum, and maximum. Summary statistics for categorical data (dichotomous and polychotomous variables) include counts in the number of missing, and the number of observations, as well as percentages for each level. Concordance will be assessed as the percentage of completeness and accuracy of data elements across select structured data domains/fields comparing patient-mediated PHR data against EHR-extracted data (considered as benchmark)