Comparing health data across countries has never been a simple task for medical researchers, but it’s even more difficult to analyze data about patients with lower limb absence/amputation (LLA). Prosthetic devices and other assistive technologies vary greatly in availability around the globe, and doctors in different jurisdictions have been collecting different information about their LLA patients based on their local norms. Numerous articles have described how the prosthetics and orthotics sector lacks a unified voice because the terminology and types of tests performed on LLA patients differ so greatly from country to country. The purpose of this project was to develop a consensus around the most important Core Data Set and Outcome Measures that will be collected by providers (doctors) when they perform consultations to users (patients) with lower limb amputation/absence. The lack of an international language for standard protocols surrounding prosthetics and orthotics prevents effective tracking of patient progress and reduces data readability and comparability for medical researchers.
CollaborateUp designed and facilitated two series of highly participatory and engaging consensus building processes to develop standardized medical registries for all stakeholders seeking to improve lower limb absence/amputation (LLA) outcomes. This consensus building process brought together nearly 60 academics, bioengineers, prosthetists, healthcare providers, clinicians, healthcare managers, researchers, and prosthetic users to share their personal experiences and preferences for a standardized Core Data Set and Outcome Measures for a LLA registry. In order to obtain input from all parties, CollaborateUp designed and administered a total of 8 surveys and conducted 8 virtual meetings over the course of 6 weeks. The surveys were sent to all consensus process participants, with 4 surveys relating to the Core Data Set and the other 4 relating to Outcome Measures.
Given the project guidelines for a true consensus building process, CollaborateUp created consensus surveys and modified them each week based on the results of our virtual discussions. The 8 virtual meetings were geared towards drawing out participants’ own experiences working in a clinical setting with amputees, researching orthotics from a university, or wearing a prosthetic in their day-to-day life. CollaborateUp established from the start that participants were highly encouraged to offer suggestions and provide pushback on the possible LLA registry items.
The survey responses on each Outcome Measure or Core Data Set registry item were considered to have consensus if they met a threshold of 75 percent participant agreement. Survey questions that did not have a 75 percent consensus in responses were then discussed in greater detail during our virtual consensus meetings. Hearing perspectives directly from prosthetic users was tremendously helpful in the ISPO’s ability to narrow down the most essential LLA registry items for both Outcome Measures and a Core Data Set.
An event in December launched the COMPASS (Consensus Outcome Measures for Prosthetic and Amputation Services) and the LEAD (Lower Extremity Amputation Dataset). The event detailed the need for improved data collection and data analysis, presented the final LEAD and COMPASS, gave examples of how data could be used to inform health policy for improved, efficient rehabilitation services, and highlighted future directions. A publication detailing the COMPASS and the LEAD was published in Prosthetics and Orthotics International in October 2021.