Because of growing resources devoted to individuals requiring community care for leg ulcers,1,2 the Ottawa Community Care Access Centre (CCAC) established and evaluated the feasibility of a dedicated community leg ulcer service. CCAC is the regional authority responsible for home care in Ontario, Canada. Approximately 1 million people live in the catchment area, which includes urban and rural areas. Health care in the province is provided through a publicly funded health insurance system that covers the entire population. Regionally based home care authorities broker nursing and other services from for-profit and not-for-profit providers.
Both regionally based and individual nursing agencies are moving toward the use of practice guidelines for wound care. With a goal of providing evidence-based care, an interdisciplinary Leg Ulcer Protocol Task Force was formed to review existing practice guidelines, determine their suitability for use by the new service, and incorporate the appropriate evidence-based recommendations into a local community care leg ulcer protocol. This paper illustrates the Task Force's experiences in developing and updating the Ontario Leg Ulcer Community Care Protocol.
Task Force researchers developed a conceptual framework-the Practice Guideline Evaluation and Adaptation Cycle-to facilitate the systematic development of a local evidence-based leg ulcer protocol (Figure 1).3,4 The leg ulcer care protocol, initially developed and released in September 2000,5 was reviewed again 2 years later during a regularly scheduled review and revision. The protocol development process involved 10 major steps, as follows: (1) identify a clinical area to promote best practices; (2) establish a guideline evaluation group; (3) establish a guideline appraisal process; (4) search and retrieve existing guidelines; (5) assess the quality, currency, and content of existing guidelines; (6) adapt guidelines for local use; (7)external review; (8) finalize local guidelines; (9) official endorsement; and (10) scheduled review and revision. These steps are further explored below.
IDENTIFY A CLINICAL AREA TO PROMOTE BEST PRACTICES
Leg ulcer care was identified as a clinical area in which best practices should be promoted, based on several factors: (1) the concern about increasing resources devoted to this condition, particularly the cost of supplies; (2) the sense that considerable practice variations existed in the care of leg ulcer patients in the region; and (3) the limited use of known effective treatments (eg, compression therapy).6
Partnering with these researchers, the CCAC began a regional prevalence study of leg ulcer care; a knowledge, attitudes, and practice (KAP) survey of home care nurses and family physicians; and a cost analysis of caring for individuals with leg ulcers.1,2,6 The data were then used to justify and guide the development of an evidence-based leg ulcer service.
The next major task was determining best practices for leg ulcer care in the new service. The decision was made to examine existing guidelines to determine if any were suitable for adoption, rather than developing new rigorous practice guidelines.
ESTABLISH A GUIDELINE EVALUATION GROUP
The CCAC, together with a nursing agency, established an interdisciplinary Leg Ulcer Protocol Task Force. The rationale for establishing the interdisciplinary committee was to ensure that all key provider stakeholders were present and could offer input on issues crossing disciplinary boundaries, such as referral criteria and treatment.
The initial Task Force included a community enterostomal therapist, a community nurse, a home care manager, a special project and research officer from the home care authority, physicians (vascular surgeon, dermatologist, hematologist/epidemiologist, and family physician), and health service researchers (health sociologist, nurse scientist, and health information specialist).
Interest in the protocol after its release led to expansion of the Task Force to include another enterostomal therapist, another family physician, and 2 visiting home nurses from 3 other regions in the province. This expanded group updated the protocol.
ESTABLISH A GUIDELINE APPRAISAL PROCESS
The appraisal process for existing practice guidelines included selecting a guideline appraisal instrument and establishing criteria for selecting guidelines to appraise. Based on a review of existing guideline appraisal instruments,7 the Appraisal Instrument for Clinical Guidelines8 was selected for its ease in application and its acceptable reliability and evidence of validity.9,10
The 37-item guidelines appraisal instrument was divided into 3 dimensions that allowed comparison of guideline quality:
- Dimension 1 (20 items) focused on the rigor with which the guideline was developed.
- Dimension 2 (12 items) focused on guideline context and content and assessed the issues of guideline reliability, applicability, flexibility, and clarity.
- Dimension 3 (5 items) assessed guideline dissemination and monitoring and addressed issues related to guideline application.
Each guideline appraiser's ratings were scored, with each guideline given a standardized dimensional score ranging from 0 to 100. A score of 100 indicated that all appraisers considered that a guideline had fulfilled all criteria for that dimension.9 A user manual ensured that all questions were interpreted consistently. Although version 2 of the Appraisal Instrument for Clinical Guidelines (AGREE Collaboration Writing Group)11 was available when updating the protocol, the original instrument was retained to compare the quality scores of the newly identified guidelines with those already appraised.
In addition to using the Appraisal Instrument for Clinical Guidelines, appraisers were asked to provide global assessments of the guideline as a measure of overall quality.
Appraisers provided an overall numerical rating of guideline quality and an assessment of whether the guideline should be recommended. For example, they were asked, "Overall, how would you rate the quality of this guideline on a scale ranging from 0 to 10, with 0 indicating the lowest possible quality and 10 representing the highest possible quality?" Each appraiser's guideline recommendation was elicited by asking whether he or she would "strongly recommend this guideline for use in practice without modifications," "recommend this guideline for use in practice on condition of some alterations or with provisos," or "not recommend this guideline (not suitable for use in practice)."
For manageability, the Task Force initially restricted the appraisal process to guidelines that:
- were developed or updated after 1998 (1 year after a systematic compression therapy review clearly demonstrated the benefit of this therapy)12
- focused primarily on management of leg ulcers
- were written in English (translation capacity was unavailable)
- provided references to the scientific literature (evidence-based guidelines must, at least, include references).
The decision to restrict the focus to guidelines published after 1998 was based on limited resources, the need to keep the guideline evaluation task manageable, and limited evidence suggesting that guidelines older than 3 years are more likely to become outdated.13 All guidelines initially appraised were developed between 1998 and 2001.
SEARCH FOR AND RETRIEVE EXISTING GUIDELINES
The Task Force identified existing guidelines by searching MEDLINE and the Internet using the following medical search headings (MeSH) and text words: clinical practice guideline(s), consensus standards, consensus statement, leg ulcer(s), practice guideline(s), and venous stasis. Known Web site practice guideline databases and the US National Guideline Clearinghouse were also searched.3 Originally, 19 potential leg ulcer guidelines were identified (MEDLINE, 14; Internet, 4; and colleagues, 1). Ten of 19 were eliminated because they were developed or published before 1998.14-23 In addition, 4 others were excluded: 1 was not in English,24 1 was not strictly about leg ulcer management,25 1 did not provide references,26 and 1 was incomplete.27
Five guidelines met the Task Force's criteria for guideline appraisal: the Royal College of Nursing (RCN),28-29 the Scottish Intercollegiate Guidelines Network (SIGN),30 the Clinical Resource Efficiency Support Team of Northern Ireland (CREST),31 the Compliance Network Physicians/Health Force Initiative (CNP/HFI),32 and the Venous Insufficiency Epidemiologic and Economic Studies (VEINES) Task Force33 (Table 1). Two guidelines were not identified by MEDLINE. The same approach was used when the protocol was reviewed for updating, with 2 additional guidelines identified: the New Zealand Guidelines Group34 and the Canadian Association of Wound Care.35
It should be noted that despite the inclusion criterion of reviewing only guidelines published after 1998, the group was asked to consider the University of Pennsylvania guideline.22 This guideline was published before the cutoff date. Because adding another guideline into the evaluation process had resource implications, the group focused on the 3 national professional bodies and 2 international groups that met inclusion criteria.
ASSESS GUIDELINE: QUALITY
Next, each identified guideline was independently appraised using the appraisal instrument. The Task Force received a copy of the guideline, together with the appraisal instrument. Nine to 12 individuals appraised each guideline. In all cases, the appraisal was completed by at least 3 community nurses, an enterostomal therapist, a physician, and 2 researchers. The results were tabulated using Statistical Package for the Social Sciences software (SPSS Inc, Chicago, IL).
The quality dimension scores for the original 5 guidelines and the 2 guidelines added at the update are presented in Table 2. Standardized quality scores related to the rigor of guideline development (Dimension 1) ranged from 10% to 72% (interpreted as the percentage of items addressed by the guideline). Generally, guidelines had higher scores on the dimension of context and content (Dimension 2) than Dimension 1 (2 scores ranged from 33% to 75%). On guideline application (Dimension 3), quality scores ranged from 0% to 70%.
Table 2 also shows the results of questions used to assess overall guideline quality. The mean global quality rating (range, 0 to 10) for the guidelines ranged from 3 (VEINES) to 8.4 (RCN). The global assessment rating (ie, strongly recommend, recommend with modification, do not recommend) differentiated 3 guidelines, with 5 or more appraisers strongly recommending the RCN, SIGN, and NZ guidelines. The CREST and CNP/HFI guidelines were overwhelmingly recommended with modification (CREST, 11 of 12 appraisers recommended with modification; CNP/HFI, 9 of 10). Most appraisers failed to recommend VEINES and CAWC.
To identify recommendation similarities and differences, the Task Force conducted a content analysis of guideline recommendations (Table 3). Content analysis revealed certain variations in the recommendations and differences created by levels of evidence assigned to the recommendations by different guideline developers.
ASSESS GUIDELINE: CURRENCY
Guideline release information is found in Table 1. The updating process determined that none of the original 5 guidelines had undergone any additional updates.
ASSESS GUIDELINE: CONTENT
Quality scores from the Guidelines Appraisal Instrument (Table 2) and a systematic comparison of the specific recommendations from each guideline (Table 3) formed the basis of discussion and consensus building, which led to adoption and adaptation of the local protocol recommendations. The Task Force used the data (Table 2) to fully appreciate the quality differences among the guidelines being reviewed, as well as members' views regarding recommendations for use in practice. Table 3 focuses the discussion regarding specific guideline recommendations and their potential for local application. Greater importance was placed on recommendations with more evidence or, when evidence was lacking, those with greater agreement across the guidelines.
Although formal group processes, such as Delphi or nominal group techniques,36-38 may help participants reach consensus on each recommendation, these processes may be artificial and cumbersome. Instead, informal group discussion was selected to reach consensus, as this approach emulates the way decisions are often made in clinical settings.
ADAPT GUIDELINES FOR LOCAL USE
Although the Task Force favored many RCN guideline recommendations, it also drew on recommendations from the SIGN, CREST, and CNP/HFI guidelines. Three NZ guideline recommendations were later incorporated into the protocol when it was updated. Acknowledging the potential problems inherent when taking recommendations out of context, the Task Force did not adapt any recommendation to such an extent that the recommendation was no longer in keeping with its originally justifying evidence. The Ontario Leg Ulcer Community Care Protocol Reference Guide, which synthesizes the Task Force's adaptation of international guidelines, is presented in Figure 2. A detailed protocol was also developed that includes specifics, level of evidence and supporting references, and rationale for each recommendation.
A draft of the initial protocol was sent to community nurses and family physicians for external review. Of the 96 randomly selected physicians surveyed, 69 (72%) responded; of these, 93% indicated that the protocol should be adopted by the CCAS- "as is," 82%, or with "minor modifications," 11%. Certain physicians questioned where patients could be referred for Doppler assessments, and several raised concerns about remaining involved in patient care.
In addition, a home care nurse focus group was held to review recommendations and offer feedback, with the nurses unanimously supporting the protocol. The draft protocol was sent to 3 recognized leg ulcer care experts who were not involved in selecting the protocol recommendations. They reviewed the document and confirmed that the Task Force had not inappropriately adapted any guideline recommendations.
FINALIZE LOCAL GUIDELINES
Practitioner feedback was considered, with all responding physicians contacted to address their individual issues. The protocol document was then finalized and ratified by the Task Force. With no major changes, the Task Force did not resend the protocol document for further review. When needed, however, soliciting additional comments is useful for obtaining clinician feedback, disseminating the protocol, and encouraging clinician buy-in.
The CCAC endorsed the protocol in Ottawa, Ontario, where it was adopted by a large community nursing agency (Ottawa Victorian Order of Nurses). In this setting, the leg ulcer service consisted of a dedicated team of primary and secondary nurses who provided care in patient homes and 2 nurse-run leg ulcer clinics.
In Kingston, Ontario, the protocol was endorsed by an interdisciplinary wound care working group, spanning the hospital and community sectors and consisting of nurses and physicians. Leg ulcer care in this region is only provided in the home.
In the Waterloo region of Ontario, the protocol was adopted by ET NOW, a nursing agency contracted to provide dedicated wound and ostomy care. ET NOW provides services in both home and long-term-care settings. Nurses perform ankle-brachial index assessments in the home or clinic, depending on the service delivery model in each setting.
SCHEDULED REVIEW AND REVISION
To complete the final step in the process-scheduled protocol review and revision-another literature guideline search was conducted. Quality and content of newly found guidelines were appraised and guideline recommendations were incorporated into the Recommendations Matrix, as required (Table 3). The Task Force reviewed the information and discussed inclusion of new recommendations in the protocol. The protocol document was then updated and redistributed to all clinical partners.
The Practice Guideline Evaluation and Adaptation Cycle revealed that an interdisciplinary group of relevant stakeholders could systematically appraise, review, and compare practice guideline recommendations and produce and update a local protocol in a timely manner.
A valid and reliable guideline appraisal instrument added legitimacy to the process, helped focus the group, and permitted easy identification of methodologic and content strengths and weaknesses of different guidelines. Future efforts to appraise guideline quality should use the AGREE Instrument (http://www.agreecollaboration.org).11 With careful content analysis of the recommendations included in the various guidelines, the interdisciplinary group easily identified those recommendations that were most appropriate for the local setting. Searching the Internet in addition to MEDLINE allowed the group to locate guidelines posted on the Internet prior to or in place of publication in MEDLINE-indexed journals.
Because the appraisal process is time consuming, busy clinicians had to be convinced of the value of appraising the guidelines and, as needed, reminded and encouraged to complete their appraisal. As clinicians focused on the recommendations, with each level of supporting evidence, an environment was created in which group members could question and challenge local expert opinions or current practices that contradicted the evidence. The process led to a "made at home" clinical protocol that incorporates the best available evidence from international practice guidelines. Local practitioner review addressed the concerns and issues of local providers before the protocol was finalized. The protocol review by external leg ulcer experts increased the Task Force's confidence in the appropriateness of their adaptation of the international guidelines.
The Task Force observed that in addition to directly promoting evidence-informed leg ulcer care through the protocol, the experience of participating in the guideline evaluation and adaptation process increased knowledge of existing practice guidelines. Previously, nurses were more familiar with guidelines developed by nursing bodies; physicians were more familiar with guidelines developed by medical bodies. Transferring literature search and guideline appraisal and adaptation skills to Task Force members enhanced the local capacity to continue evaluation and adoption of best practices. The philosophy of striving for best practices through use of the best available evidence became ingrained, with other areas of care (eg, diabetic foot care) being worked through a similar process.
In addition to the Task Force's positive experiences with the process and the protocol, a pre/post evaluation of the implementation of the new service in 1 region showed statistically significant differences.39 Focusing on individuals with venous disease, the overall 3-month healing rate in the year before protocol implementation was 23% (n = 18/78) (venous disease, 22.8% [n = 13/57];mixed venous disease, 23.8% [n = 5/21]). In the year following protocol implementation, the overall healing rate increased to 55.6% (n = 100/180) (venous disease, 58.7% [n = 64/109]; mixed venous disease, 50.7% [n = 36/71]). The median number of nursing visits declined from 37 to 25 (P = .04), and the median supply costs declined from Can $1538 (US $1236) to Can $325 (US $261) per case (P = .005). The data validate the regional leg ulcer protocol and support the value of the described process for evaluating and adapting existing guidelines for local use.
Practice guidelines are necessary, but not sufficient, in the move to evidence-based practice. Uptake and implementation of an existing practice guideline requires proactive effort and purposeful attention. The Practice Guideline Evaluation and Adaptation Cycle offers a framework for adapting well-developed national or international clinical practice guidelines for local application. This step-by-step approach ensures the process is systematic and rigorous, and it efficiently promotes best practices by raising health care providers' awareness of evidence-based recommendations and adapting them for local use. The development and uptake of this protocol was advanced through the iterative nature of the practice guideline evaluation and adaptation cycle. This framework would also be useful to health care providers in other settings who wish to support evidence-based practice. The Task Force encourages others to use the framework and report their experiences.;
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