Date Published: September 23, 2019
Publisher: Public Library of Science
Author(s): Peiying Zhang, Qian Lu, Huijuan Li, Wei Wang, Gaoqiang Li, Longmei Si, Yanming Ding, Tim Mathes.
This study aims to evaluate the quality of clinical practice guidelines(CPGs) for patients with diabetic foot worldwide. A search of guidelines websites, databases and academic institutions websites was performed from January 1st, 2010, until June 30th, 2018. Four assessors independently rated the quality of each CPG using the Appraisal of Guidelines for Research and Evaluation (AGREE) II instrument. Twelve CPGs satisfied the inclusion criteria. The median scores for the 6 AGREE II domains (scope and purpose, stakeholder involvement, rigor of development, clarity of presentation, applicability, and editorial independence) were 92.5%, 72.5%, 71.5%, 89%, 47%, and 77%, respectively. The overall quality of the CPGs was good since the majority of the CPGs reached an overall guideline quality between 5 and 7 points. Different CPGs had widely varying scores in the same area, ranging from 25 to 94 points.
Diabetic foot (DF) is a common and serious complication of diabetes mellitus. The prevalence of diabetic foot ulceration is about 6.3% worldwide. Individuals with diabetes and DF have been reported to be three times more likely to die at any time than those with diabetes who do not have DF . Such patients undergo suffering and bear an enormous economic burden [3, 4]. Standardized and scientific treatment can improve patient outcomes, save medical resources, and reduce unnecessary costs for patients. However, there is great variation in the treatment and management of DF in different areas and hospitals. High-quality CPGs for use in clinical practice are recommended as a decision-making tool. In 1990, the Institute of Medicine (IOM) provided a definition for clinical practice guidelines, which were systematically developed statements to assist practitioner and patient decisions regarding appropriate health care for specific clinical circumstances . As the best methods for guideline development have evolved, the IOM updated the definition of clinical practice guidelines which states that “clinical practice guidelines are 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 new definition better reflects the current consensus on what constitutes a clinical practice guideline. A high-quality CPG must be based on systematic review and balance benefits and drawbacks. However, the non-systematic creation of guidelines can lead to considerable variation, with implications for the quality of care and clinical decision-making . Therefore, finding CPGs regarding DF and evaluating their quality are essential. CPGs help reduce inappropriate practice variation, promote the translation of research into practice, and improve health care quality and safety.
Twelve CPGs meeting the criteria were included in our study. Five CPGs issued by the International Working Group on the Diabetic Foot (IWGDF) covered five aspects of DF. These CPGs were developed using the same method. They were therefore evaluated as one CPG. A flowchart illustrating our search of the CPGs is shown in Fig 1.
This study aims to evaluate the quality of clinical practice guidelines for diabetic foot worldwide. We identified twelve CPGs that discuss DF developed based on evidence from 2012 until now. The median scores for the 6 AGREE II domains (scope and purpose, stakeholder involvement, rigor of development, clarity of presentation, applicability, and editorial independence) were 92.5%, 72.5%, 71.5%, 89%, 47%, and 77%, respectively. The overall quality of the CPGs was good for the majority of the CPGs reached an overall guideline quality between 5 and 7 points. Different CPGs had widely varying scores in the same area, ranging from 25% to 94%. Clinical guidelines could be effective in improving the care provided to patients [31, 32]. The CPGs for DF performed well in the domains of “scope and purpose” and “clarity of guideline”, as also reported in other studies[12, 33]. Development of CPGs must be performed by a team, and potential participants in the development of the guideline should include clinicians, content experts, researchers, and policymakers. Most commonly, guideline development groups consist of 10 to 20 members from 3 to 5 relevant disciplines . A rigorous and transparent process for the development of guidelines is essential [34, 35]. The CPGs here had moderate rigor scores, as the median score in this domain was 71.5%. Systematic search for evidence, explicit inclusion and exclusion criteria, and the grading of evidence are basic components of rigor in guideline development. However, half of the CPGs lost points for having little information regarding these components. CPGs are expected to report specific methodological information regarding external review by experts and on how to formulate recommendations. The best way to interpret the link between the recommendations and the supporting evidence is to present evidence summaries or tables to the users in the guideline. A common problem presented in the CPGs studied here is that they do not contain sufficient explanations regarding the application of guidelines. This was an issue that was also regularly observed in other fields of research [10, 12, 36]. In the applicability domain, facilitating the efficient use of these evidence-based resources is also a key point during the development of CPGs. Future CPGs are expected to identify barriers and facilitators in implementing guidelines, provide tools or other resources promoting implementation, and provide cost information on the recommendations. The CPG from the RNAO set a good example in this respect. Of course, some conceptual models can also guide the implementation of CPGs for researchers and clinical staff. These models include the Knowledge-to-Action model , Ottawa model , and integrated–Promoting Action on Research Implementation in Health Services model . The process of obtaining information regarding conflict of interest and its description should also be strengthened. We suggest that there should be a scientific development standard for guideline developers. The AGREE II may also be used as a guide for guideline development. Finally, we suggest that all developers upload attachments when issuing the guidelines. This would enhance the quality of the methodology and transparency.
The CPGs for DF demonstrated good quality, although their applicability and reporting quality should be strengthened. In all guidelines, the domain “Scope and purpose” receives the highest score of 92.5% and the domain “Applicability” receives the lowest score of 47%. With this appraisal of current clinical practice guidelines for DF, Health care professionals can not only recognize DF CPGs, but also know which CPGs are more trustworthy and of potential high quality.