Endpoints for Wound Patients – Do We Really Care?

There seems to be a lot of confusion between Patient Reported Outcomes (PRO) and Quality Measures. I see those terms get used interchangeably. A PRO is a measurement of patients’ perception of their own health status or quality of life. A PRO instrument is a scientifically designed survey instrument that is developed and tested to accurately and reliably capture some concept(s) of self-perceived health status.

Some patient reported outcomes have been approved by CMS as Quality Measures that can be reported for credit under the Merit Based Incentive Payment System (MIPS). A good example of those are the PROMIS measures.

PROMIS was developed with funding from the National Institutes of Health (NIH) and has now been taken over by Northwestern University. You can obtain various types of PROMIS tools on tablets or you can provide them to patients via a paper form. CMS has approved these to be used as Clinical Practice Improvement Activities (CPIA) as well.

A Qualified Clinical Data Registry (QCDR) could develop a “non-MIPS” quality measure (that can be reported for MIPS credit) or a practice Improvement Activity (IA) around any PRO. Here’s the way CMS words the IA associated with measuring patient reported outcomes: “Participation in a QCDR, demonstrating performance of activities for promoting use of patient-reported outcome (PRO) tools and corresponding collection of PRO data.”

In other words, if an organization or entity develops and validates a data collection instrument as a PRO (regardless of whether it is collected electronically or on paper), then a QCDR could turn that activity into a quality measure or practice improvement activity for credit under MIPS.

In point of fact, the USWR did that with wound-related Quality of Life (w-QoL). We spent the money to license this validated tool, develop it into a quality measure, and got CMS to approve it among the first group of measures we launched in 2014. However, last year CMS rejected it. I’ll repeat that: CMS rejected measuring Patient reported wound-related Quality of Life as a quality measure that could be reported under MIPS. The reason given by CMS was that simply measuring wound related QOL wasn’t sufficient to be considered a quality measure. It would be necessary to show that wound care had improved quality of life by some specific percentage. I had given the wound related QOL to 400 patients in my wound center, and to 100 of those both before and after wound care. I sent the QOL data along with about 75 different elements of clinical data (e.g. diagnosis, wound measurements, wound outcome, etc.) to the developer, but they were not able to get a grant to analyze the clinical data in relation to the QOL. So, we weren’t able to estimate whether and by what percentage wound care could be expected to improve wound-related QOL using this tool. As a result, I gave up the idea of measuring quality of life among patients with wounds.

I gave up measuring quality of life among patients with wounds because I had personally funded the initiative to that point only to have CMS reject the measure, because no entity involved in the treatment of wounds cared enough to fund the analysis of the data, and no wound care doctors had any incentive to report wound related quality of life. It’s expensive to launch PROs. There has to be a reason to do it. So, despite the lip service given to how much we supposedly care about PROs such as improvements in quality of life – I still say it’s all just talk. CMS doesn’t care enough about patient reported outcomes like Quality of Life to incentivize collecting it as a quality measure,  and  manufacturers don’t care enough to fund the additional analysis that is needed.

It’s a shame, because The Center for Devices and Radiological Health (CDRH or Center) has released a report entitled, “Value and Use of Patient-Reported Outcomes (PROs) in Assessing Effects of Medical Devices.” It is part of their 2016-2017 Strategic Priorities which was to Partner with Patients by incorporating the patient perspective as evidence in their decisions. PROs are commonly used in medical device regulatory submissions as a measure of the patient experience with a medical device, and wound care uses a lot of medical devices like Negative Pressure Wound Therapy (NPWT) and cellular and/or Tissue based products (CTPs). It’s likely those devices are going to need PROs in the future.

The CDRH report provides some useful links to questionnaires. Since 2016, CDRH includes a summary of patient perspective data considered in Premarket approvals (PMAs) and de novo decisions.  FDA decision summaries and other useful information are available in web-accessible searchable databases. The device manufacturers should care about PROs. Maybe one of them will fund the analysis of the wound-related quality of life data on 400 patients that’s sitting in someone’s computer – and support resubmitting a QOL quality measure to CMS. I will believe we will care about patient reported outcomes when that happens.


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