Abstract and Introduction
Data from registries can be especially useful in the evaluation of healthcare effectiveness. Thus, the goal of this study was to report on use of the US Wound Registry to investigate the outcomes of a broad population of patients undergoing treatment. Using a 5-year slice of de-identified data from electronic health records originating from 59 hospital-based outpatient wound centers in 18 states, outcomes, patient and wound variables, and costs for facility and physician fees and procedures were analyzed for 5240 patients with 7099 wounds. Mean patient age was 61.7 years with 52.3% being male and the majority Caucasian (73.1%) and Medicare beneficiaries (52.6%). The mean number of serious comorbid conditions per patient was 1.8, with the most common being diabetes (46.8%), obese or overweight (71.3%), and having cardiovascular or peripheral vascular disease (51.3%). More than 1.6% of patients died in service or within 4 weeks of the last visit. Almost two thirds of wounds healed (65.8%) with an average time to heal of 15 weeks and 10% of wounds taking 33 weeks or more to heal. The average wound surface area was 19.5 cm2. Half of wounds that healed did so with only the use of moist wound care (50.8%) and without the need for advanced therapeutics. Mean cost to heal per wound was $3927 with jeopardized flaps and grafts the most expensive ($9358). This Registry would seem ideal for comparative effectiveness research in wound care, as it includes patients often excluded from randomized controlled trials and reflects actual practice.
A rough population prevalence rate for chronic nonhealing wounds in the United States is 2% of the general population. A conservative estimate of the staggering cost of caring for these wounds exceeds $50 billion per year.[2–5] This is 10 times more than the annual budget of the World Health Organization. Despite the fact that the prevalence rate of chronic wounds is similar to that of heart failure, unlike heart failure, little is known regarding the outcome of these patients or the comparative effectiveness of the treatments they receive. Randomized controlled trials (RCTs) in wound healing are infrequent compared to problems of similar prevalence, and almost without exception are funded by the pharmaceutical or wound management industry on the conceptual framework of "is product A better than product B" under rigorously controlled conditions, including a limited portion of the affected population. Although patient care does improve as better products and devices become available, such trials are costly and time consuming, generally exclude patients with serious comorbidities, and are never directed at patients with the hardest to heal wounds (eg, sickle cell ulcers, vasculitis, scleroderma). Patients with chronic wounds suffer from a multitude of comorbid conditions that would have excluded them from nearly every RCT performed in the past 10 years. RCTs in wound care have also consistently failed to provide data on the most vulnerable populations such as those with dementia, the disabled, racial minorities, and the very elderly. Nevertheless, most of what we know about wound "outcomes" has been derived from these studies (eg, healing rates, time to heal). Some wound care-related businesses have reported "healing rates" as a measure of the success of their program or product, but these data have been vetted (usually post hoc) by excluding patients classified as "palliative care" or those with "anticipated amputations" so that the apparent success of the program is not impacted by patients unlikely to do well.
The Institute of Medicine (IOM) has promoted the collection of outcome information as a byproduct of documenting care within electronic health records (EHRs), which could be mined for outcome and other patient-related information. The Federal Coordinating Council for Comparative Effectiveness Research (CER) Report established that "longitudinal linked electronic health record (EHR) databases or patient registries should be a major area of investment for [comparative effectiveness] research." The strong external validity of registries is achieved by the fact that, unlike RCTs, they include "typical patients." As discussed in the AHRQ document on "Registries for Documenting Patient Outcomes, a Users Guide," registry data can provide a good description of the course of a disease and impact of interventions in actual practice. Data from registries can approximate the effects of interventions as well as RCTs, and may be particularly useful in the evaluation of health care effectiveness.[10–12]
Driven by the need for such real world data from patients with chronic wounds, particularly those with multiple comorbid conditions, in 2005 the authors created a registry of wound care patients from de-identified electronic health records. The registry provides a window on the real world effectiveness of current wound care interventions. Because of the unique ability of the EHR to automate charge calculation and track-associated costs, the authors also have access to information regarding resource utilization. Thus, the goal of the present study was to report on use of the US Wound Registry to investigate the outcomes of a broad population of patients undergoing treatment among hospital-based outpatient wound centers across several states. This study is not a cost effectiveness study, although such a study is possible with the registry.
Wounds. 2012;24(1) © 2012 Health Management Publications, Inc.
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