January 2012

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Original Research »

Producing Precise Outcomes in Randomized, Controlled Trials and Clinical Studies

Thu, 1/12/12 - 11:08am | 0 Comments | 982 reads

Index: WOUNDS 2012;24(1):3–9

  Abstract: Evidence-based medicine (EBM) uses the current best evidence to inform decisions about care of individual patients, healthcare procedures, and technologies. The “gold standard” for optimal evidence in the Cochrane system is Level I randomized, controlled trials (RCTs) and meta-analyses of several RCTs. In order to achieve this level of evidence, one of the most important measures is the use of outcomes/endpoints. This article will provide, in short form, recommendations on how to achieve rigorous endpoints or outcomes in studies on wound management. Consistency in measuring endpoints/outcomes improves quality of care. To achieve such consistency it is important to 1) use predefined and robust outcomes; 2) adapt outcomes to the intervention under investigation; and 3) use the best evidence available. Also, it is emphasized that the use of complete wound closure or healing as an outcome measure is not always possible or suitable. Remaining patient-focused clarifies which other endpoints are relevant. Finally, “basic care” must be clearly defined and standardized when used as a comparative intervention in a RCT. In conclusion, the use of correct, clinically relevant outcomes or endpoints is of vital importance when establishing optimal evidence in wound healing and care.


 

Original Research »

Wound Care Outcomes and Associated Cost Among Patients Treated in US Outpatient Wound Centers: Data From the US Wound Registry

Thu, 1/12/12 - 11:47am | 0 Comments | 1485 reads

Index: WOUNDS 2012;24(1):10–17

  Abstract: 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.


 

Review »

Benchmarking Chronic Wound Healing Outcomes

Thu, 1/12/12 - 12:27pm | 0 Comments | 711 reads

Index: WOUNDS 2012;24(1):18–24

  Abstract: Background. Benchmarking chronic wound outcomes (comparing outcomes achieved in practice to those reported elsewhere) begins with documenting and summarizing individual and cohort outcomes of one’s practice, continues with searching for comparable results, and is completed by improving care if benchmark outcomes exceed one’s own. Objective. Literature reviewed illustrated this cycle of document-summarize-search-compare outcomes of a recognized healing measure—percent completely healed within 12 weeks of care. Methods. MEDLINE and Association for the Advancement of Wound Care (AAWC) Venous and Pressure Ulcer Guidelines and Evidence Table searches identified example healing benchmarks from randomized controlled trials (RCTs) with 100 subjects/group with a diabetic foot ulcer (DU), venous leg ulcer (VU), or pressure ulcer (PU). Graphed benchmarks were compared to outcomes reported for same-etiology cohorts to illustrate institutional and patient-level benchmarking. Results. Cohorts in some settings reported results similar to the best RCT results for DU and VU. More adequately powered PU RCTs are needed to provide full- and partial-thickness PU benchmarks. RCTs have strengths and limitations as benchmarking resources. Risk-adjusted analyses would improve benchmarking. Conclusion. Documenting and comparing outcomes to published results can support current interventions, highlight opportunities for improvement, or ensure that interventions applied are working to meet individual patient and wound care goals.


 
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