Here’s some straight talk on clinical pathways. We’ve all gotten the message on “evidence based” medicine by which payers use data, primarily from randomized controlled trials (RCTs) to decide what treatments they will cover. I’ve had some concerns about that since Dr. Marissa Carter and I published a paper showing that nearly 75% of the patients in wound centers would have been excluded from every wound care RCT published between 1998 and 2008. In other words, the RCTs are “non-generalizable” – meaning, they don’t include the sick patients we see, but the results are used to determine whether certain treatments are covered.
As any wound care clinician knows, the key to good outcomes is not providing one specific “evidence based” therapy, but methodically performing a host of interventions many of which are simply appropriate usual care. This methodical approach to patient care can best be described as a “pathway.” A good pathway ensures that a patient gets (in a logical sequence)—basic blood work, vascular screening, regular off-loading and/or compression, nutritional assessment, treatment of deep tissue infection, debridement, etc. If the wound has not closed by at least 30% within 30 days, then it is not on a healing trajectory and advanced therapeutics may be considered. That’s when the discussion about pathways gets interesting.
In conjunction with the Institute for Clinical Outcomes Research (ICOR), the USWR has predictive models for each major wound type that can estimate the likelihood that a given wound will heal. These models could be used to prioritize advanced therapeutics for patients whose wounds have a low likelihood of healing. We also have a model that can predict the number of HBOT treatments needed to improve a DFU (and which might be used to predict those patients for whom HBOT is futile).
Payers have already created customized pathways for oncology patients. They are now beginning to do it for wound care patients. These pathways could theoretically use models to prioritize certain types of care, or to omit certain interventions (like hyperbaric oxygen therapy) altogether. They are being written now by virtually every major payer.
In an April white paper, The Personalized Medicine Coalition said that payers need to work with stakeholders early on to structure clinical pathways appropriately, given that evidence needed to justify the use of “personalized medicine” like this is likely to take more time and require additional information. The National Patient Advocate Foundation has raised concerns surrounding payers’ use of clinical pathways in a July report, saying that transparency must be an important aspect of clinical pathways. At the very least, patients should have the right to know when their physician is participating in a clinical pathway. Avalere also raised transparency as a concern in own report on the issue. The report said there is limited public information about pathway development and the degree of flexibility clinicians have to adopt treatment plans that deviate from a pathway to meet patients’ needs.