Support surfaces are an integral component of pressure ulcer prevention and treatment, but there is insufficient evidence to guide clinical decision making in this area. In an effort to provide clinical guidance for selecting support surfaces based on individual patient needs, the Wound, Ostomy and Continence Nurses Society (WOCN®) set out to develop an evidence- and consensus-based algorithm. A Task Force of clinical experts was identified who: 1) reviewed the literature and identified evidence for support surface use in the prevention and treatment of pressure ulcers; 2) developed supporting statements for essential components for the algorithm, 3) developed a draft algorithm for support surface selection; and 4) determined its face validity. A consensus panel of 20 key opinion leaders was then convened that: 1.) reviewed the draft algorithm and supporting statements, 2.) reached consensus on statements lacking robust supporting evidence, 3.) modified the draft algorithm and evaluated its content validity. The Content Validity Index (CVI) for the algorithm was strong (0.95 out of 1.0) with an overall mean score of 3.72 (out of 1 to 4), suggesting that the steps were appropriate to the purpose of the algorithm. To our knowledge, this is the first evidence and consensus based algorithm for support surface selection that has undergone content validation.
The peripheral nerve injury repair market is rapidly evolving as a result of new and disruptive technologies now available to nerve repair surgeons. The question of market size is of keen interest to all stakeholders but its determination presents significant challenges. A market size determination without consideration of clinical decision factors and how they directly impact the selection of repair method and device/product utilizations will be lacking in important information. This is especially true in the context of newer technologies and their potential impact on the market. A market size estimate without consideration of claims data would ignore critical components in estimating procedure numbers and therefore be at risk of inaccuracies. For most medical device/product companies, the challenge of building a market size estimate model that enlists robust data and clinical decision making information can be a daunting undertaking. The need to provide a convincing method of market size determination and present it to all stakeholders in a meaningful way is central to success. Failure to achieve these goals can harm a company’s credibility and impact investor confidence/enthusiasm, marketing efforts and ultimately impact the trajectory of the company’s future.
Magellan Medical Technology Consultants was contracted to determine the market size for the transected peripheral nerve injury repair market in the U.S. To build a comprehensive and robust market estimate model, Magellan used claims data from national databanks on DRG and CPT claims codes as well as national Emergency Department statistics on trauma data. These data served to establish the number of peripheral nerve transected repairs cases per year. Magellan also administered an on-line survey to nerve repair surgeons and developed a clinical decision device/product selection model. Magellan combined these disparate data sets and analyzed them to produce a robust market estimate model. This model produced a U.S. market size estimate of $1.68 billion dollars per year. Magellan produced a white paper that details the methods and results of the steps used to establish this market size estimate.
Skin injury related to medical adhesive usage is a prevalent but underrecognized complication that occurs across all care settings and among all age groups. Little guidance exists in the literature regarding appropriate selection and proper use of adhesive products to minimize medical adhesive–related skin injury, as well as best practices for skin care preventive strategies, application and removal techniques, and assessment and treatment of such injuries. In an effort to define best practices for prevention of such injury, a consensus panel of 23 recognized key opinion leaders convened to establish consensus statements on the assessment, prevention, and treatment of medical adhesive–related skin injury. The consensus summit was held in December 2012 and was made possible by an unrestricted educational grant from 3M.
Magellan Medical Technology Consultants was contracted to assist in facilitating this important consensus summit. Magellan managed the project, starting with the planning stage and continuing through literature review, ranking of evidence, consensus statement development, creation of a state of the science summit presentation, and the consensus voting process. After the summit, Magellan provided medical writing assistance for this manuscript, which details the consensus definitions and statements established during the summit and identifies research priorities for development of new adhesive technologies and protocols for skin protection.