How can real-world evidence aid decision making during the life cycle of nonprescription medicines?

Real-world evidence (RWE) is an emerging scientific discipline which is being increasingly utilized for decision making on prescription-only medicines. However, there has been little focus to date on the application of RWE within the nonprescription sector. This paper reviews the existing and potential applications of RWE for nonprescription medicines, using the nonprescription medicine life cycle as a framework for discussion. Relevant sources of real-world data (RWD) are reviewed and compared with those available for prescribed medicines. Existing life-cycle data gaps are identified where RWE is required or where use of RWE can complement data from randomized controlled trials. Published RWE examples relating to nonprescription medicines are summarized, and potential relevant future sources of RWD discussed. Challenges and limitations to the use of RWE on nonprescription medicines are discussed, and recommendations made to promote optimal and appropriate use of RWE in this sector. Overall, RWE currently plays a key role in specific phases of the nonprescription medicine life cycle, including reclassification and postmarketing safety surveillance. The increasing availability of patient-generated health data is likely to further increase the utilization of RWE to aid decision making on nonprescription medicines.

Incorporating patient generated health data into pharmacoepidemiological research.

Epidemiology and pharmacoepidemiology frequently employ Real-World Data (RWD) from healthcare teams to inform research. These data sources usually include signs, symptoms, tests, and treatments, but may lack important information such as the patient's diet or adherence or quality of life. By harnessing digital tools a new fount of evidence, Patient (or Citizen/Person) Generated Health Data (PGHD), is becoming more readily available. This review focusses on the advantages and considerations in using PGHD for pharmacoepidemiological research. New and corroborative types of data can be collected directly from patients using digital devices, both passively and actively. Practical issues such as patient engagement, data linking, validation, and analysis are among important considerations in the use of PGHD. In our ever increasingly patient-centric world, PGHD incorporated into more traditional Real-Word data sources offers innovative opportunities to expand our understanding of the complex factors involved in health and the safety and effectiveness of disease treatments. Pharmacoepidemiologists have a unique role in realizing the potential of PGHD by ensuring that robust methodology, governance, and analytical techniques underpin its use to generate meaningful research results.

Determination of the abduction-adduction axis of rotation at the human knee: helical axis representation.

This study used a finite helical axes representation to derive the axis of rotation of the human knee in the frontal plane for the neutral flexion/extension posture during resting and no load-bearing conditions. The three-dimensional finite helical axis pathway of the tibia relative to the femur was computed by passively adducting/abducting the lower limb via a servomotor system. Knee joint movements as a result of the positional perturbations were captured with an active marker kinematic tracking system. Contrary to traditional assumptions used in studies conducted under a similar experimental paradigm, our results indicated that the knee joint center, defined as the intercept point between the finite helical axis and the mid-coronal plane of the distal femur, was located within the femoral notch for a wide range of abduction and adduction angles (6 degrees abduction to 6 degrees adduction angles). Our data also indicated that at the neutral posture of the knee, the helical axes directions change as a function of the abduction/adduction perturbation angle. These findings are not only essential to error minimization during joint moment calculations, but can also facilitate new biomechanical interpretations of, for example, the functional role of the quadriceps and patellofemoral joint mechanics to overall knee stability in the medial-lateral direction.