The overall score ranged from 2 to 7 of 7 across CPGs. Fifty-one (44%) CPGs scored 5 or greater, whereas 64 (56%) scored less than 5.
Overall, 72 (63%) CPGs were recommended for future use with modifications, 21 (18%) were recommended for use without modifications, 16 (14%) were not recommended, and for 6 (5%) CPGs, appraisers did not agree whether the CPG should be recommended.
Only 6 CPGs explicitly described in the guideline document that a patient representative was included in the working group and had contributed to the development of the guideline.
The majority of CPGs (n = 71) did not describe sources of funding for the development of the CPG. Of those that described funding sources (n = 44), the majority were funded by nonindustry (n = 27), followed by industry (n = 7), a mixture of industry and nonindustry (n = 4), whereas 6 CPGs stated that no funding was received.
The ICC across CPGs ranged from 0.28 to 0.92, indicating a fair to almost perfect level of interrater agreement. The average interrater reliability was substantial at 0.74.
Ninety-three item score adjustments occurred across CPGs. Score adjustments most commonly occurred in the domain “editorial independence,” specifically for item 22 (the views of the funding body have not influenced the content of the guideline). Item score adjustments did not alter the average domain scores across CPGs, and there was only 1 difference in the order from highest to lowest scoring items. Item 10 (the methods for formulating the recommendations are clearly described) moved up from 15th position to 14th position and item 22 moved down from 14th position to 15th position. There were no adjustments across CPGs for the 2 overall ratings.
Variability in the methodology and quality of 115 CPGs in Ktx was found in this systematic review. The highest scoring domain was “scope and purpose” followed by “clarity of presentation,” which is consistent with previous international studies where these domains have also scored highest.3-5,127,128 These 2 domains are important because they look at the overall language, structure, and format of the guideline as well as the overall aim, health questions, and target population. Simple, easy to understand CPGs appear to be the most accessed by clinicians and more likely to be implemented.129-131 The majority of CPGs adhered well to the items within these domains, indicating that guideline developers worldwide may understand the value and importance of these components. It may also be that the fulfillment of these components does not require a large amount of resources.132 It is encouraging that guideline developers are getting these aspects correct, as without adherence to these domains, CPGs may form cumbersome, complex documents that are likely ineffectual in clinical practice.
The poorest scoring domain was “applicability” which is consistent with previous studies.3-5,127 All items in this domain scored poorly across CPGs. The “applicability” domain examines whether CPGs have provided advice or tools for putting recommendations into practice, described facilitators and barriers in implementation, considered the resource implications of applying recommendations, and presented monitoring or auditing criteria. Unlike other domains, adhering to the aspects of “applicability” may require a larger amount of resources via the implementation of pilot testing, economic evaluations, educational tools, and patient leaflets.6 Useful CPGs however are those that can be adapted to clinical practice, not those that merely excel in theoretical content, and CPGs that are not clinically applicable arguably waste time and resources when recommendations are not used by the intended health practices.130 Decision making at the point of care may be compromised because without accessibility to reliable and replicable guidance, uncertainty remains. Treatment may be potentially delayed and inconsistencies emerge, which creates difficulty when assessing outcomes. A lack of proper consideration of the underlying evidence or poor clarity in presentation will also affect a clinician's confidence in the guidelines, meaning that adherence is less likely. Moreover, there is a potential harm to healthcare systems when limited resources are expended on prescribed interventions that are unaffordable, or compromise operating efficiency.133 Despite this, developers continuously overlook the applicability of CPGs. Organizations might need to consider refraining in developing CPGs unless they have the necessary funding and resources to address these aspects.
Comparatively, the domains “rigor of development” and “stakeholder involvement” scored slightly better, although still averaged poorly overall. Described as the strongest indicator for guideline quality, the domain “rigor of development” examines the processes used to gather and synthesize the evidence.127 Clinical practice guidelines based on poor-quality evidence risk the recommendation of suboptimal, ineffective, or even harmful practices.133 The use of systematic methods in the searching and selection of evidence are scrutinized in this domain, as well as reporting the strengths and limitations of evidence used to inform recommendations via specific instruments, such as Grading of Recommendations Assessment, Development and Evaluation (GRADE) and the Jadad scale. Informal tools may also be used, but the essential component is transparently reporting all methods used in the identification, inclusion, and utilization of the evidence. Many CPGs are developed with low-level evidence or without the inclusion of evidence, instead based on expert opinion.134,135 The rationale behind this is that they provide continuity to clinical practice where there is a need for guidance and the evidence is poor. Reporting all methodological aspects is therefore particularly essential to allow the users of CPGs to judge the validity of the content.
Also examined within this domain is the undertaking of external reviews and including a procedure and date for CPG revision, items where CPGs again scored poorly. The external review is an important aspect as those individuals not directly involved in the process of CPG development have an opportunity to examine recommendations. Lack of awareness, familiarity, and agreement of CPGs have been identified as barriers to their usage and adherence to recommendations.131,136 The inclusion of clinicians as external reviewers may encourage those within their practice to be more engaged with the implementation of guidance.137 Involving those outside the working group may also help to ensure that recommendations are relevant, reliable, and free from bias. According to AGREE II, external reviewers should consist of both clinical and methodological experts. Also recommended is publicly documenting the methodology used, as well as all reviewer criticisms, and the rationale for any modifications that did or did not occur to ensure transparency.138
There does not appear to be a consensus on the timeframe for CPG review, possibly because this is largely dependent on the content of the CPG and how regularly new, relevant evidence materializes.139 Studies examining the validity of CPGs in healthcare show variable results where a fifth of CPGs developed in the Spanish National Health System were out of date within 5 years.140 Half of CPGs published by the US Agency for Healthcare Research and Quality were obsolete after 5.8 years, and 86% of CPGs developed by the UK National Institute for Health and Clinical Excellence were still up to date 3 years after publication.141,142 The challenge for CPG developers is to ensure recommendations are valid, reliable, and up to date without wasting time and resources in identifying new evidence if there is no significant change, or the evidence does not warrant changes to current recommendations.142 The Transplant Library is a resource that provides quick access to high-quality evidence that could warrant changes to recommendations.143 For improvements in this item, developers should document the proposed date for CPG review detailing clearly the intended methodology, monitor the literature regularly, and update recommendations when new evidence suggests the need for modification.
The poorest scoring item across CPGs was seeking the views and preferences of the target population, which is 1 of 3 items included in the domain “stakeholder involvement.” The importance of patient preferences to clinical decision making has gained steady momentum and has led to advocating the involvement of patient and public representatives in the development of CPGs.144,145 A collaborative approach is recommended which allows the formulation of CPGs that are not only evidence-based but that are more likely to be adhered to by patients and therefore useful in clinical practice. The incorporation of a patient representative in the working group and in the development of CPGs was examined in this systematic review. Disappointingly, very few CPGs included a patient representative. Similar findings are reported in a systematic review spanning 2 decades between 1980 and 2007 highlighting that little progress has been made with improving this area.127 The Guideline International Network provide a useful online toolkit which details practical support for obtaining patient perspectives via 3 main strategies: consultation, participation, and communication.146 Guideline developers would benefit from incorporating such examples in the development of CPGs to ensure they are clinically applicable to the target population.
The domain “editorial independence” examines competing interests declarations and whether recommendations may be biased by the views of funding bodies or CPG developers. Clinical practice guidelines performed moderately in this domain, and the majority of CPGs did not describe details of funding. The CPG developers may underestimate the importance of addressing and declaring all competing interests and financial aid. Alternatively, excluding this information may be a sinister way of concealing the exchange of professional or financial gains for the promotion of specific recommendations. Clinical practice guidelines are widely distributed and have the power to influence clinical practice protocols, and unethical or unsafe recommendations must not be put forward for personal or organizational gain. Preventing competing interests in CPG development is a difficult and complex task. Excluding individuals with conflicts of interest in the involvement of CPG development is a possible solution; however, this is dependent on self-reporting, and evidence suggests that many individuals are not transparent, or even aware of their own conflicts of interest.147 It may also be difficult to exclude certain individuals with conflicts of interest because their expertise is not replaceable.148 Similarly, considerable time and resources are involved in the development of CPGs, and funding may not be available from nonconflicting organizations. Conflicts of interest and involvement of funders in CPG development should be reduced as much as possible to avoid biased guidelines.148 The CPG users would benefit from explicit, publicly accessible details of funding and conflicts of interest, which will increase their confidence about the reliability of CPGs for clinical practice.
This systematic review has limitations. Included CPGs were published in English only, the majority of which were developed in Australia and the United States. Therefore, the overall mean results were largely influenced by the CPG development procedures in place in these countries. Systematic searches located CPGs published in journals; however, manual searches were constrained to include international transplantation societies that would be producers of CPGs. The majority of these societies were located in developed countries, indicating that the quality of CPGs in developing countries are likely underrepresented in this systematic review. A study that surveyed international members of The Transplantation Society on the uptake of a CPG on cytomegalovirus management in solid organ transplantation reported that 20% of respondents were from developing countries.149 It may be that CPGs from developing countries are sparse, and this community relies on CPGs published by other national and international organizations. A large portion of CPGs included in this systematic review were produced in 2010 and 2011 and could be considered out of date. However, because these CPGs have not been updated and are currently available for use in clinical practice, the inclusion of these CPGs is relevant to the overall quality of international CPGs. Clinical practice guidelines on all aspects of Ktx and kidney donation were included in the systematic review, enabling an extensive range of topic areas to be covered. However, because of this variability, recommendations could not be compared across CPGs.
A strength of the systematic review is the use of 3 appraisers for all CPGs, which included individuals with a methodological background and kidney transplant clinicians. The rationale for inclusion of both was to ensure that the examination and interpretation of CPGs was representative of differences in clinical and methodological opinion. Appraisals were completed individually and multiple appraisers with differing affiliations were used to limit the influence of confirmation bias. All appraisers completed the training module before appraising any CPGs and the ICC demonstrates that there was a good cohesion between all appraisers.
The AGREE II instrument incorporates specific criteria for all 23 items, however, is limited by a lack of guidance on how to make the overall assessments. Appraisers could have rated these differently depending on which aspects of CPG development they felt were most representative of overall CPG quality.127 There is also no cutoff to distinguish between high- and low-quality clinical practice guidelines, an aspect identified as important by many users.150 The number of items in each domain is not consistent and items attributed to “rigor of development” or “applicability” will have less of an effect on the overall domain score compared to items in the “editorial independence” domain. As with all critical appraisals, the AGREE II is also dependent on methodological reporting. CPG developers may have used utilized methods not described in the document.
The quality of international CPGs in Ktx requires significant improvement. Only a small number of CPGs scored well overall and were recommended for future use without modifications. The majority scored poorly overall and required modification, and a small number were not recommended for future use. All CPGs demonstrated variability in domain and item scores with most performing well in the domains “scope and purpose” and “clarity of presentation” and poorly in the domain “applicability.” The CPG developers should pay closer attention to the components of the AGREE II and endeavor to incorporate them into CPGs. Many aspects could be easily improved without an additional burden on time and resources. High-quality CPGs will support evidence-based decision making and will ultimately lead to better outcomes for kidney transplant recipients.
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