Nearly every week I get a question about the different registry participation options for wound care and hyperbaric medicine. We need all the data we can get in the fields of wound care and hyperbaric medicine. The thought process should not be that one approach is better than another. Different types of registries serve different purposes.

Maybe the following overview is useful:

The US Wound Registry – USWR

  • The US Wound Registry is comprised of IDENTIFIED ELECTRONIC HEALTH RECORD DATA.
    • Data are de-identified when they are extracted for analysis
    • Because the registry has identified patient data, outcomes can be linked to Medicare Claims data to understand the impact of certain diseases or treatments on the cost of care
  • Participating clinics and practitioners agree to transmit the entire patient EHR to the USWR.
    • There is no “secondary data entry” (no one has to sit down and enter data into a database).
    • There is no patient selection bias (a huge problem for registries and the primary reason that the FDA does not trust them) because 100% of patients are included along with 100% of their problems.
  • For data to be useful for research, it needs structure that allows information to be collated and compared. The reason that this particular EHR data can be used for research is that the EHR was specifically designed with structured fields so that when data was entered into the EHR in the usual course of patient care, it was entered primarily through menu driven options that facilitate later analysis.
  • The purpose of the USWR is to facilitate physician participation in the Quality Payment Program and to track the natural history and outcome of patients with specific disease states and/or their response to specific treatments (e.g. treatment with hyperbaric oxygen therapy or cellular and/or tissue based products, or who have conditions like diabetic foot ulcers,  or late effects of radiation, etc.).
  • The USWR is recognized by CMS as a Qualified Clinical Data Registry (QCDR)
  • The USWR develops quality measures which can be used for the purpose of reporting quality data to CMS as well as to determine whether patients received the appropriate standard of care (or “usual and customary care”).
  • Because the USWR is a quality registry, an institutional IRB review is not required to participate.   However, when data are extracted for analysis, an IRB reviews the plan for using the data.
  • The HBOTR data has already been used to defend the physician payment rate for HBOT (by demonstrating the number of comorbid conditions of patients undergoing HBOT and their number of medications).
  • More information:
  • Read the White Paper on Analysis of Bias Criteria Checklist for Wound Care Registries & EHRs, available from the USWR.

The tools needed to participate in the USWR will soon be available via a “SMART  app” for Cerner. This will allow practitioners to report wound and hyperbaric oxygen therapy quality measures without secondary data entry, directly from their hospital EHR and participate in the USWR and the hyperbaric oxygen therapy registry. Eventually a similar app will be available for the Epic EHR.

Dartmouth Registry

I’ll ask Dr. Jay Buckey from Dartmouth to post a guest blog about the Dartmouth registry. However, as a “big picture,” the Dartmouth registry contains de-identified data. This means that the data cannot be linked to Medicare claims data down the road. Data are entered via secondary data entry (this means that someone must enter data “by hand” into a database). The data structure for research is provided through the data collection tool. You have to do the manual data entry process of transferring data from medical records into the registry. The goals of a project like this have to be clearly established ahead of time because the data fields have to be built to answer specific questions. Keep in mind that it requires IRB approval for a facility or practitioner to participate in the Dartmouth registry. You do not need a specific EHR or “app” to participate in the Dartmouth registry, however, you will have to input data by hand on each patient, and it suffers from patient selection bias since no one knows which patients were NOT entered.

We need all the data we can get. It’s probably too late to save some HBOT indications because we needed to be committed to the registry process a decade ago. I hope we don’t make the same mistake with the current off-label indications. As the use of off-label HBOT increases, clinicians should collect registry data on the off-label indications so we can better understand what DOESN’T work– which is what the ethicists Chan and Brody recommended more than a decade ago.

I tried to demonstrate the differences between the USWR and the Dartmouth registry with the table below but remember this is not a CONTEST.

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