The International Consolidated Venous Ulcer Guideline Update 2015: Process Improvement, Evidence Analysis, and Future Goals
In 2015, members of the Association for the Advancement of Wound Care (AAWC), Wound Healing Society, and the Canadian Association for Enterostomal Therapy formed the International Consolidated Guidelines Taskforce to update the AAWC Venous Ulcer Guidelines to the collaborative, intersociety, endorsed International Consolidated Venous Ulcer Guideline.
This “guideline of guidelines” integrates recommendations from all relevant, published evidence-based guidelines on venous ulcer care and prevention. The update process was conducted in accordance with the National Guideline Clearinghouse inclusion criteria and was informed by a systematic review of the evidence, with additional content validation of each venous ulcer management recommendation. Twenty-three (23) wound experts participated. Compared to the 2010 version of the guideline, A-level recommendations increased from 62% to 77%, 31 recommendations were removed, and new recommendations included quality of life evaluations and surgical treatment options. Gaps in the evidence and needed areas for research include surgical, topical, and pharmaceutical interventions. Collaboration among societies and stakeholders and rigorous guideline development processes may expedite the implementation of evidence-based practices, fill in research gaps, and provide a powerful unified voice to regulatory and reimbursement agencies with the ultimate goal of improving outcomes for persons with a venous ulcer.
Sackett et al,1 later supported by Thoma and Eaves,2 defined evidence-based medicine as “integration of the best evidence from systematic research with clinical expertise and patient values.” Evidence-based practice informs clinical judgment, using evidence and the risks/benefits of a therapy to assess the most appropriate treatment plan for patients. Clinical-based practice guidelines (CPGs) derived from a rigorous review of the evidence have been developed by primary care and specialty societies to support clinician and patient decisions about appropriate health care in specific clinical circumstances.3 More broadly, CPGs consolidate the evidence, which serves as recommendations, benchmarks, or standards of care widely available to all health care stakeholders. Thousands of guidelines are available for clinicians and patients; however, not all CPGs are developed to the same evidence or recommendation standards. A review4 found a wide variety of standards is evident in bias, usability, and effectiveness in providing specific recommendations for clinicians to implement. Many guidelines are untested and often lack validation, which contributes to a lack of acceptance and poor CPG implementation rates.5 As elucidated by Kredo et al6 in a guideline development review, challenges remain in the integration of CPGs into electronic health records, adaption for multiple care settings, and conversion into patient shared decision making aids.
Institute of Medicine (IOM)/National Guideline Clearinghouse (NGC) guideline process. In 2011, the IOM3 redefined CPGs as “statements that include recommendations intended to optimize patient care that are informed by a systematic review of evidence and an assessment of the benefits and harms of alternative care options.” This updated definition was needed to ensure a standardization of guideline development and to improve the quality and trustworthiness of the data, which had not been consistent previously. Similarly, in 2014 the NGC7 followed suit and mirrored the IOM, requiring all included guidelines to be based on a systematic review of the evidence as well as an assessment of the risks/benefits of all recommendations and alternative options. Currently, the NGC requires updates at least every 5 years and has strict criteria for guideline development and processes. In a validity study of current guidelines, Shekelle et al8 found 90% of CPGs were still valid after 3.6 years but that 50% were out of date within 5.8 years; these authors also recommended updates every 3 years to reduce the burden of the process and to maintain the most current and relevant evidence. Further, guideline methodologists9,10 are examining best practice strategies to update guidelines given the onerous amount of work required. Some suggested methods include ongoing, focused reviews of evidence that can range from monthly to every 3 years.
Venous Ulcer Guideline Background
In 2002, the Association for the Advancement of Wound Care (AAWC) formed its Guidelines Task Force to develop evidence-based CPGs for the treatment of venous ulcers (VUs). The first iteration, the Venous Ulcer Care Initiative (VUCI), was published on the NGC site in 2005 and an updated version was accepted in 2010.11 The inaugural 24-member, multidisciplinary, all-volunteer Task Force consisted of 4 APNs, 7 wound ostomy continence (WOC) nurses, 5 physicians, 4 physical therapists, 2 PhDs, 1 DPM, and 1 registered pharmacist. During project initiation, the group identified perceived barriers to the practice of quality, evidence-based VU management and resolved to develop a unified VU guideline, applicable across specialties, to align wound care evidence and practice across the continuum of care. For the 2005 VU guideline, the group agreed by consensus on pioneering a “guideline of venous ulcer guidelines” development methodology, which included assembling all recommendations from existing VU guidelines and replacing consensus with content validation as a criterion for including a recommendation in the guideline. The volunteer multidisciplinary wound care team members, practicing in a variety of settings, independently rated the clinical relevance of unique recommendations in an online survey. This process is described previously.11
Subsequently, guideline developers systematically reviewed MEDLINE, CINAHL, and Cochrane databases to find best available evidence supporting each recommendation using standardized, recognized evidence criteria adapted from those used to develop prior Agency for Healthcare Research and Quality (AHRQ) pressure ulcer guidelines.8 Recommendation categories included patient assessment, supporting diagnostics, risk factor screening, wound assessment and management, compression treatments, monitoring, patient-centered outcomes, and prevention of future ulcers. The 2010 update included a systematic review of the new evidence and resubmission to NGC.
For the 2015 AAWC Venous Ulcer Guideline (VUG) update, the AAWC formed the International Consolidated Guidelines Task Force (ICGTF) and invited wound societies from the United States and around the world to collaborate. The VUG, which began as the VUCI, was renamed the International Consolidated Venous Ulcer Guideline (ICVUG) in 2015. Current members in the ICGTF include the Wound Healing Society (WHS), the Canadian Association for Enterostomal Therapy (CAET), the Japanese Wound Healing Society, and the Asociación Mexicana para el Cuidado Integral y Cicatrización de Heridas AC.12
The ICGTF began the process of updating the ICVUG based on the IOM and NGC criteria. The ICVUG is intended to inform VU clinical care decisions with best available evidence and content-validated relevance using standardized, current opinion ratings and the extent to which each recommendation confers more benefit than harm as independently rated by multidisciplinary individuals skilled in wound care. The process of inter-society guideline development and results of the collaborative ICVUG update are described.
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.
A total of 27 source guidelines were included in this update, compared to 21 source guidelines in 2010.11 Several previous source guidelines had been withdrawn from the NGC, while societies such as the AVF and the Society of Vascular Medicine produced new guidelines in the interim.13
The 2015 ICVUG includes 7 overall categories of VU care, 33 major recommendations, and 106 minor recommendations to guide and educate clinicians on best practices. Of the 141 recommendations, 77% of the evidence supported an A-level grade, 4% was B-level, and the remaining 18% was C-level evidence. This represented a marked increase in the amount of A-level-supported evidence since the last update (77% versus 62%). Each major category of ulcer care had evidence that was upgraded to A-level in the ICVUG I (see Table 1). Thirty-one (31) recommendations from the 2010 VUCI were removed because either they did not meet CVI of >0.75 or lacked A-level evidence criteria to support their use (see Table 2).
In 2013, Morton et al17 reviewed the 2010 VU guideline update to identify areas for research. Many gaps in evidence identified in 2010 still remain as gaps in evidence after the 2015 review.11,17 Numerous recommendations for nutritional, biophysical adjuncts, surgical care, and topical interventions were removed because they did not have new evidence added since 2010 and the CVI was <0.75. Recommendations on the use of sharp debridement, timing of wound biopsy, physical therapy exercises, and negative pressure are among those with updated/higher level evidence in the ICVUG. Interestingly, the final major recommendations on palliative care did not have any supporting evidence higher than C3 (expert opinion)1 in either the 2010 VUG or the 2015 ICVUG; this indicates an important area for research and improvement. New evidence added to support surgical interventions was attributed to a recent VU guideline by the SVS in 2014.13
One (1) major area identified in the 2015 update is assessment of depression and the impact of VUs on quality of life. Previously, this was a poorly assessed aspect of VU care.5 Twelve (12) new recommendations to monitor quality-of-care indicators (pain, depression, and other health-related quality-of-life issues) were included based on the MEDLINE searches. These were added after the content validation survey was completed, so content validity and SOR (for these new recommendations) will be added at the next formal update. Another area that was expanded was the section on compression therapy; new recommendations have become available to help clinicians inform their decision making.
The ICGTF guideline development process provided a transparent, collaborative mechanism that linked organizations involved in the care of people with venous ulceration, clarified each wound care team professional’s unique role and contributions to the field, and improved validity and effectiveness of CPG implementation.
Agreement among societies sends a powerful message to regulators and payers when issues of treatment, prevention, reimbursement, and coverage arise. Wound healing societies and stakeholders are wise to take note of these ventures and find common ground to provide effective, evidence-based, high-quality care to patients. Collaborative ventures, such as this ICGTF, demonstrate that representative societies understand the critical need for a unified voice. A recent joint CPG released by The American Podiatric Medical Society and the SVS on the management of the diabetic foot is an example of such opportunity in action.18 Further intersociety collaboration and publication will strengthen stakeholder positions when advocating for coverage and reimbursement as well as the ability to optimize effectiveness of guideline implementation across care settings.
By transparently compiling all recommendations of all clinically relevant guidelines, the ICGTF procedure ensures the guidelines are comprehensive, relevant, and interdisciplinary, meeting IOM standards for “guidelines one can trust.”3 In addition to updating the recommendations, content validation was performed again to ascertain clinical relevance and to rate the strength of the recommendations.
Next Steps and Limitations to Address
A well-known gap remains between guideline publication and clinician implementation.5,18,19 To bridge settings and specialties and encourage consistency across the care continuum, the IGCTF develops implementation tools to accompany released guidelines, which is not standard for guidelines.5 These tools include simplified checklists, 1-page professional and patient brochures congruent with the guidelines, and teaching slides; these are available from www.aawconline.org and any participating ICGTF organization that chooses to share this link. Implementation tools can be valuable in supporting institutional quality improvement programs, professional education, and providing rationale for choices of actions taken.
The ICVUG cites compelling evidence that medical-grade compression is the gold standard for treating VUs, yet a retrospective analysis19 of a large wound care registry involving real-time clinical data by Fife et al showed only 17% of clinicians actually apply it; the authors posit the reasons that evidence-based treatments are not universally implemented “can be explained by the high cognitive effort to either learn or remember the treatment, the complexity of implementing the treatment, and the lack of sufficient reimbursement for performing the treatment. Adjusting reimbursement (whether correcting regional inequities or issues with supplies), improving physician education (perhaps via point of service reminders or ensuring that societal guidelines arrive at the national level), and decreasing complexity with easier-to-use products would shift the equation toward better compliance.” According to Van Hecke et al,5 the broad distribution of wound care guidelines via the internet and through wound healing associations ensures clinicians have access to clinical practice guidelines that can improve VU care.
ICGTF guidelines are designed to unify care by serving all members of the wound care team (including the patient) across all settings, highlighting care consistent with recognized quality measures.19-22 Limited health care resources led to global recognition of the need to provide better care at lower cost. This has resulted in multinational attempts to define, benchmark, and incentivize the use of quality metrics. However, these metrics must be defined by evidence and focus on aspects that make a difference in the quality of care, with objective and measurable outcomes. Hence, the use of quality measures for VUs is likely to improve compliance with clinical practice guideline recommendation. Linking reimbursement to quality measures provides a powerful incentive to adhere to evidence-based care, but this mechanism requires intense scrutiny and validation before implementation.
Currently, a comparison study23 showed very few accepted quality measures relevant to wound care and even fewer that are directly related to VU care are available. In the US, wound care clinicians can contribute data to this effort through qualified clinical data registries such as the US Wound Registry. The current set of 20 wound-related quality measures drafted by the US Wound Registry include 9 that are specific to VU care.23 Further analysis of registry data will identify which quality measures lead to better patient outcomes and provide additional data to enhance clinical practice guidelines. These data also can be used to analyze the implementation of guideline recommendations, which currently is an under-researched area.
A continuing challenge remains in the translation of evidence into practice of the ICVUG for use by those intended to benefit: the person who lives with a VU. The AAWC has developed patient education pamphlets consistent with these content-validated, evidence-based venous CPGs. However, involvement of the patient in the guideline process and electronic linkages to shared decision-making aids for use at the point-of-care remain goals for development. A comparison study24 and a prospective, quasi-experimental, descriptive study25 showed unified content-validated, evidence-based guidelines developed from all relevant guidelines with implementation tools that serve patients and all members of the wound care team, across specialties, settings, and borders can improve the consistency and quality of wound care and outcomes, reducing costs of implementation. ICGTF guideline development processes offer opportunities to unify wound care guidelines so all professions and societies can move past outdated consensus to collaborate in consistently using of evidence-based, content-validated wound care.
The complexity of wound care patient encounters as well as wound care policy decision-making demands reliable, valid, evidence-based CPG resources. A “guideline of guidelines” condenses all relevant recommendations and evidence into a content-validated bundle that serves every member of the wound care team, including the patient, and makes it widely available for dissemination among stakeholders. ICVUG meets those standards and has added endorsements from multiple wound healing associations in the US and abroad. All interested organizations are invited to collaborate in developing future ICGTF venous and pressure ulcer guideline updates as well as similarly developed guidelines on wound infection and diabetic foot ulcers.
A call to action is in place to report quality measures related to VU care reflected within the ICGTF guidelines. Wound care has a unique opportunity to meet that call and hopefully reduce the gap between research and provision of care, employing collaborative team practice in applying ICVUG. Gaps remain between practice and research, requiring rigorous clinical research to improve outcomes for patients with VUs. ICVUG sets the stage for following content-validated recommendations that serve the whole wound care team using current best available evidence to improve the consistency and quality of care and outcomes for patients with a VU.
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Potential Conflicts of Interest: none disclosed
Ms. Couch is a nurse practitioner, Wound Healing and Limb Preservation Center, George Washington University Hospital, Washington, DC. Ms. Corbett is an advanced practice nurse, Hartford Hospital, Hartford, CT. Dr. Gould is a physician, Kent Hospital Wound Recovery and Hyperbaric Medicine Center, Warwick, RI. Ms. Girolami is a registered nurse, Maineville, OH. Dr. Bolton is an adjunct professor, Department of Surgery, Robert Wood Johnson University Medical School, New Brunswick, NJ. Please address correspondence to: Kara S. Couch, MS, CRNP, CWS, Wound Healing and Limb Preservation Center, 900 23rd Street NW, Ground Floor, Washington, DC 20037; email: firstname.lastname@example.org.