Systematic searches of the NGC guideline database and CINAHL, MEDLINE, and Cochrane reference databases using the search terms venous ulcer and guideline identified all relevant source guidelines to be included for the ICVUG update. Major and minor recommendations from all source guidelines were evaluated, condensed, and clarified before content validation by 23 wound care respondents from a variety of specialties and settings. The evidence used to inform each major/minor recommendation then was reviewed and updated by the ICVUG task force. Of the 1069 studies identified and evaluated by systematic literature review of evidence supporting each recommendation, 533 were included in the guideline. All evidence reviewed and included in the update was published before December 31, 2015.
From each recommendation-focused literature search, the ICVUG team selected up to 5 references representing the “best available evidence” supporting the recommendation per the previously published standardized criteria for the highest level of published evidence.1 Many recommendations had A-level evidence sufficient to inform clinical decisions. Updated references were added to the ICVUG Evidence Table that followed corresponding recommendations in the guideline. This part of the process was extremely labor-intensive and took many months of volunteer team member hours. The final steps were to update the implementation tools and then resubmit to the NGC, which was done in March 2016.
Collaboration among societies. All wound care member organizations were invited to participate in the ICGTF guideline development process. It offered opportunities for subspecialists in all settings within the wound care community to use guidelines to reinforce each other’s work on effective wound care teams, refer appropriately, and examine practice evidence. Not only is guideline collaboration resource-efficient, but it also encourages synergy. In this process, representatives from the WHS studied the ICVUG working document, added new evidence, and offered suggestions to harmonize the ICVUG with the recently updated WHS CPG. In addition, CAET members of the ICVUG team added evidence and participated in the content validation portion of the update. With these methods, consistency, patient care and wound outcomes improve as all relevant parties are using the same set of guidelines to inform their practice. For example, inclusion of the recent guideline published by the Society for Vascular Surgery (SVS) and the American Venous Forum (AVF) offered depth and strength in analysis of the evidence regarding surgical interventions.13
The content validation survey was sent electronically to all members of the AAWC and WHS; 2000 invitations were sent and 31 people responded. These subject matter experts contributed comments to simplify each recommendation into a clear, actionable statement of who does what to whom, by when, and under what circumstances. Expected outcomes to be monitored are specified within the recommendation as appropriate. Respondents also were asked to content-validate each recommendation for relevance using a 4-point Likert scale (1 = not relevant, 2 = too confusing to decide, 3 = relevant, need to improve, 4 = relevant and succinct). Content validity of a recommendation was sufficient for guideline inclusion if its content validity index (CVI — the percent of online survey respondents rating it 3 or 4 for clinical relevance) was at least 0.75.
IOM-required Strength of Recommendation (SOR) relates to a recommendation’s capacity to do patients more good than harm.10 Respondents to the online survey rated this as 2 = more benefit than harm, 1 = similar benefit and harm, or 0 = more harm than benefit. The average SOR is included with each recommendation for guideline user information. A good strength of recommendation is a score of 1.50 or more.
According to work by Bolton et al12,14,15 and Black et al,16 this objective method of guideline development surpasses consensus and provides clear operational definitions for opportunities for research and education within the wound care field. Widely believed recommendations, with a high CVI but weak supporting evidence, offer opportunities to inspire future research; recommendations with a low CVI (rarely believed) but with strong evidence offer opportunities for education. As a result, these “guidelines of guidelines” not only reveal the soundness of evidence informing current wound care decisions, but they also inspire research and education to improve future decisions.