The primary objective of this systematic review is, for the first time, to identify and conduct a critical evaluation of all English language evidence-based clinical practice guidelines (EB-CPGs) pertaining to the management of acute ankle injuries in adults through the application of the AGREE II instrument.
We identified five EB-CPGS which fit our inclusion criteria, and these covered important areas of clinical practice. However large areas of practice have yet to be addressed by CPG committees (Table 2) Furthermore, even those published guidelines have significant deficiencies.
Table 2
Categories of clinical practice relating to ankle injuries that are or are not covered by these five evidence-based clinical practice guidelines.
Area/Type of Injury
|
Sprain
|
Dislocation
|
Fracture
|
A) Diagnosis
|
|
|
|
- Physical Examination
|
Yes
|
Yes
|
-
|
- Imaging
|
Yes
|
Yes
|
yes
|
B) Treatment
|
|
|
LAF related
|
- Conservative
|
Yes
|
-
|
-
|
- Surgical
|
DFTS related
|
-
|
-
|
- Drugs
|
Yes, but not well-covered
|
-
|
-
|
C) Follow up: Physio/Rehab
|
Yes
|
-
|
-
|
D) Prevention
|
Yes
|
-
|
-
|
E) First Aid
|
-
|
-
|
-
|
Legend: LAF = Lateral Ankle Fracture; DTFS = Distal Tibiofibular Syndesmosis; Physio = Physiotherapy; Rehab = Rehabilitation
All five EB-CPGs that we evaluated have some relevance to soft tissue injuries of the ankle [22, 43–46], however despite the enormous worldwide burden of acute ankle injuries, we have been unable to identify any EB-CPGs that specifically focus on management of this injury in the emergency setting. In addition, although first aid officers play a crucial role in offering essential help and early care to many individuals who suffer from acute ankle injuries during work (sports, and public events [47], for example, in Australia and New Zealand, pharmacists follow RICE protocol, recommend NSAIDs, and utilize a handbook to inform their decision–making for acute lateral ankle ligament sprain (LALS) [48–50], there are no EB-CPGs designed for use by pre-hospital practitioners. In the area of orthopedic fracture management, EB-CPGs were lacking in important acute diagnostic and management categories such as disruptions to the distal tibio-fibular syndesmosis, to the medial (deltoid) ligament or management of ankle fracture in emergency-room settings.
In the existing EB-CPGs we found that no guideline achieved consistently high scores across all domains. "Ankle Stability and Movement Coordination Impairments: Ankle Ligament Sprains," which is associated with the International Classification of Functioning, Disability, and Health from the orthopedic section of the American Physical Therapy Association [22], received the highest overall score across all domains, closely followed by the NICE guideline [45] (see Fig. 2). The KNGF guideline for physical therapy in patients with acute ankle sprain [46] received the lowest overall score; as might be expected from its early development date (published 2006) ( Fig. 2). These findings indicate variations in the quality and comprehensiveness of the EB-CPGs, with some domains demonstrating higher overall quality and others with potential deficiencies, suggesting areas for potential improvement in guideline development and presentation.
Domains in which scores exceed 80% (good quality):
Overall, four domains exceeded the threshold for ‘acceptable’ quality (mean score of 60% or above): ‘Scope and Purpose’, ‘Stakeholder involvement’, ‘Rigour of development’, and ‘Clarity of presentation’. Domains "Scope and Purpose" and "Clarity of Presentation" were generally strong in all EB-CPGs assessed (range 84.7% − 93.0% and 81.9% − 90.3% respectively; see Fig. 2), indicating that these CPGs generally had clear objectives and were presented in a comprehensible manner.
Our findings also noted improved of the quality content in the rigor in the development process of ankle injury EB-CPGs over time, especially items 13 and 14 ‘The guideline has been externally reviewed by experts prior to its publication’ and ‘A procedure for updating the guideline is provided’; these had the lowest overall score among the 8 items; KNGF [46] (the oldest CPG) scored less than 10% in these two items ( see Table 3 ). External review by experts is a fundamental step in ensuring the quality and credibility of evidence-based clinical practice guidelines (EB-CPGs) prior to their publication [51, 52].
Table 3
AGREE II items’ scores and the mean score for each guideline
Item
|
Lateral Ankle Ligament Sprains
|
ACR
|
Diagnosis, Treatment and prevention of Ankle Sprains
|
NICE
|
KNGF
|
Mean
|
Score & Purpose
|
|
|
|
|
|
|
1.The overall objective(s) of the guideline is (are) specifically described.
|
100%
|
87.5%
|
91.7%
|
87.5%
|
87.5%
|
90.8%
|
2.The health question(s) covered by the guideline is (are) specifically described.
|
87.5%
|
87.5%
|
83.3%
|
83.3%
|
87.5%
|
85.8%
|
3.The population (patients, public, etc.) to whom the guideline is meant to apply is specifically described.
|
91.7%
|
87.5%
|
79.2%
|
83.3%
|
91.7%
|
86.7%
|
Stakeholder involvement
|
|
|
|
|
|
|
4.The guideline development group includes individuals from all the relevant professional groups.
|
79.2%
|
79.2%
|
83.3%
|
79.2%
|
83.3%
|
80.8%
|
5.The views and preferences of the target population (patients, public, etc.) have been sought.
|
50%
|
33.3%
|
58.3%
|
54.2%
|
29.2%
|
45%
|
6.The target users of the guideline are clearly defined.
|
76%
|
66.7%
|
95.8%
|
75%
|
95.8%
|
81.9%
|
Rigour of development
|
|
|
|
|
|
|
7.Systematic methods were used to search for evidence.
|
100%
|
70.8%
|
95.6%
|
95.8%
|
8.3%
|
74.1%
|
8.The criteria for selecting the evidence are clearly described.
|
100%
|
79.2%
|
95.6%
|
95.8%
|
45.8%
|
83.3%
|
9.The strengths and limitations of the body of evidence are clearly described.
|
91.7%
|
37.5%
|
75%
|
83.3%
|
58.3%
|
69.2%
|
10.The methods for formulating the recommendations are clearly described.
|
79.2%
|
75%
|
91.7%
|
75%
|
50%
|
74.2%
|
11.The health benefits, side effects, and risks have been considered in formulating the recommendations.
|
70.8%
|
62.5%
|
66.7%
|
100%
|
70.8%
|
74.2%
|
12.There is an explicit link between the recommendations and the supporting evidence.
|
87.5%
|
50%
|
83.3%
|
100%
|
87.5%
|
81.7%
|
13.The guideline has been externally reviewed by experts prior to its publication.
|
95.8%
|
50%
|
66.7%
|
83.3%
|
4.2%
|
60%
|
14.A procedure for updating the guideline is provided.
|
100%
|
45.8%
|
91.7%
|
70.8%
|
8.3%
|
63.3%
|
Clarity of presentation
|
|
|
|
|
|
|
15.The recommendations are specific and unambiguous.
|
83.3%
|
87.5%
|
83.3%
|
91.7%
|
87.5%
|
86.7%
|
16.The different options for management of the condition or health issue are clearly presented.
|
87.5%
|
87.5%
|
87.5%
|
87.5%
|
87.5%
|
87.5%
|
17.Key recommendations are easily identifiable.
|
95.8%
|
91.7%
|
75%
|
91.7%
|
79.2%
|
86.7
|
Applicability
|
|
|
|
|
|
|
18.The guideline describes facilitators and barriers to its application.
|
33.3%
|
29.2%
|
62.5%
|
54.2%
|
20.8%
|
40%
|
19.The guideline provides advice and/or tools on how the recommendations can be put into practice.
|
75%
|
45.8%
|
58.3%
|
91.7%
|
29.2%
|
60%
|
20.The potential resource implications of applying the recommendations have been considered.
|
45.8%
|
54.2%
|
45.8%
|
66.7%
|
16.7%
|
45.8%
|
21.The guideline presents monitoring and/or auditing criteria.
|
29.2%
|
25%
|
33.3%
|
58.3%
|
37.5%
|
36.7%
|
Editorial independence
|
|
|
|
|
|
|
22.The view of the funding body have not influenced the content of the guideline.
|
83.3%
|
75%
|
25%
|
66.7%
|
4.2%
|
50.8
|
23.Competing interests of guideline development group members have been recorded and addressed.
|
79.2%
|
83.3%
|
37.5%
|
70.8%
|
8.3%
|
55.82%
|
Domains in which scores exceed 60% (acceptable quality):
Item five in domain 2 (stakeholder involvement) evaluates the degree to which relevant experts, stakeholders, patients, and the public have contributed to diverse perspectives, experiences, and expertise, leading to the creation of more comprehensive, relevant, and effective CPGs. Item 5 ‘The views and preferences of the target population (patients, public, etc.) have been sought’ had the lowest score among the three items in this domain, and all guidelines scored < 60% on this important item. The low scores reflect the absence of multidisciplinary teams and the failure to consider patients' views and experiences during guideline development. For example, KNGF [46] and ACR [43] guidelines did not show clear information obtained from interviews of these stakeholders or from literature reviews of patient/public values, preferences or experiences. formal consultations with patients/public to determine priority topics, participation of these stakeholders on the guideline development group, or that external review by these stakeholders on draft documents had been addressed rigorously. Within specific guideline projects, patients’ opinions may be incorporated when framing the question so patients should again be engaged at the developer level by helping determine when guidelines need updating and evaluating the developer's approach to patient engagement [53].
Guideline developers need to thoughtfully consider patient engagement at each step; specific goals may dictate types of engagement utilized [54]. Engaging patients through multiple mechanisms – for example, guideline development group (GDG), participation and public comment – has advantages and may be a particularly important strategy for addressing barriers such as GDG members representing only select views [53, 55, 56].
Including professionals from various related disciplines may be perceived as complicating the process [57]. However, to improve patient care related to the guideline's topic, all relevant disciplines should be involved in the guideline development group [58]. Guideline developers actively reach out to relevant patient organizations early in the process to define the guideline's scope and include patient representatives in their panels [53, 54]. NICE, for example, actively reaches out, but the organizations often don’t respond. Additionally, they should consider searching for qualitative and other types of research on patients' values and preferences. Ensuring such engagement is crucial for enhancing the quality and acceptance of CPGs within the medical community and promoting their effective implementation in clinical practice [51].
Domains in which mean scores exceed 40% (low quality):
‘Editorial Independence’, and ‘Applicability’ domains had mean scores which fell below 60% (range 6.3% − 81.3% and 26% − 67.7% respectively; Fig. 2).
During the appraisal process we found that strategies to improve guideline implementation were seldom considered. In the five evaluated EB-CPGs applicability scores were low because developers discussed few details relating to costs, implementation barriers, or criteria for monitoring adherence. For an extended period, the prevailing assumption among guideline developers was that presenting practitioners with well-supported evidence in a structured format would automatically lead to improved performance [59, 60]. However, findings from numerous controlled trials and systematic reviews indicate that efforts to implement guidelines often fall short of significant success (Bero et al., 1998; Wensing et al., 1998; Grol and Grimshaw, 1999; Grimshaw et al., 2001; Grol 2001b)[61]. At best, small to moderate improvements in the care process have been found (usually not more than 5–10%, depending on the implementation methods used). Notably, guideline impact on patient outcomes has frequently not been studied or has been difficult to obtain (Grimshaw and Russell, 1993; Hunt et al., 1998) [32]. Applicability was also found to be the lowest-scoring domain in a recent evaluation of English language CPGs related to spine disorders [33]. Previous work by Green et. al. on CPGs and expert consensus documents related to ankle sprain also classified this domain as extremely low quality [16]. application tools should be developed, such as indicators for performance assessment, teaching materials, patient information pamphlets, or computer decision aids [34]. It is important to involve the end users in the development process to ensure local acceptance and relevance to local practice [34, 61].
Domain 5 (items 18–21) reviews the way in which the guideline addresses the applicability of the recommendations to end-users, including the identification of barriers and facilitators to implementation (item 18), advice and/or tools on how the recommendations can be put into practice (item19), the potential resource implications of applying the recommendations (item 20), and the inclusion of monitoring or auditing criteria (item 21). Items 18 and 21 had the lowest overall scores of any item. (see Fig. 3 and Table 3).
Criteria for monitoring and/or audit purposes are frequently formulated after the publication of guidelines, often experiencing a considerable delay. This requires specialized expertise that may not be readily available during the guideline development process. Institutions involved in guideline development should consider gradually integrating these monitoring and audit considerations into the early phases of the development process [62].
Editorial Independence scored low, possibly due to insufficient information about funding sources and conflicts of interest. Improving scores in this domain could be achieved by providing more comprehensive details on these aspects. New strategies for managing financial and intellectual conflicts of interest are being introduced [63–65]. It is recommended for CPGs to include information under the following headings: Contributors, Funding, Competing Interests, Provenance and Peer Review, and Author Affiliations [64]. In the domain of editorial independence, CPGs are evaluated based on the following statements: ‘The views of the funding body have not influenced the content of the CPG’ and ‘Competing interests of members of the CPG development group have been recorded and addressed’ [34, 66]. suggested that the decision pathway itself should be more transparent and require a declaration of interest before participation [67]. The extent of conflict of interest should be linked to its scope and be sensitive to time-limitation. CPG designers should have greater focus on the wider decision-making process, rather than on expert activities. Conflicts of interest can be overcome by flexibility, enhanced status of expert witnesses and by greater non-industry sponsorship of professional educational and research activities [68].