To streamline the guideline challenge

Clinical practice guidelines (CPGs) are a systematically developed body of knowledge and instructions with the noble aim of assisting healthcare providers in the choice of appropriate interventions in specific clinical situations. This means that CPGs have an impact on healthcare (provided they are implemented) and can play an important role in the elaboration of public health policies. The aims of the present Editorial are to highlight the European Society of Anaesthesiology (ESA) strategy and directions on CPG development, to describe a standardised process to be followed by future ESA CPG task forces, and to help anaesthesiologists, other clinicians and the CPG end-users to critically read and appraise them. Since its creation, the ESA has strongly supported the development of high-quality, evidence-based CPGs as a tool to harmonise and improve clinical practice in anaesthesiology (in the definition of ESA, this includes intensive care, emergency and perioperative medicine as well as pain therapy) throughout Europe. Accordingly, appropriate methodologies and rigorous strategies, which all medical Scientific Societies provide are of paramount importance in the CPG development process, because the potential benefits of CPGs are only as good as the quality of the CPGs themselves. The validity of any CPG depends on the rigour with which available evidence has been comprehensively assessed. This is an essential element if a CPG is to be trusted by clinicians and implemented into clinical practice. This is in line with the goals of promoting the best interests and values of research in Europe, and the principles of the writing and application of CPGs of the Alliance for Biomedical Research in Europe (BioMed Alliance), a nonprofit association of which the ESA is member. However, recommendations within CPGs are sometimes presented and, accordingly, perceived by the end-user clinicians as an ‘alien’ body of ‘virtual’ instructions (in some instances not strongly supported by the literature) intended to be applied at the bedside. There are several reasons why clinicians may consider CPGs as not really adapted to their clinical needs. One of them, paradoxically, is that there are many domains where CPGs do not exist and clinicians are still obliged to provide care based on individual or collective experience. The second is that in some cases, the relevance of clinical questions has been sacrificed to respect methodological constraints. The third is that many CPGs, because of lack of solid evidence, require clinical reasoning and this is not explicitly presented in most CPGs (i.e. tools for clinical reasoning are not proposed). Finally, implementation strategies are rarely part of the CPG process. What clinicians often ask for and need to know is to what extent a recommendation can be trusted. Systematic and explicit methods for assessing evidence could reduce heterogeneity among different CPGs on the same subject. If simple answers are provided to specific clinical problems then comprehension and implementation of CPGs may be improved. If clinical reasoning tools are part of the CPG, it is expected that heterogeneity in reasoning will decrease. Recommendations should be easily integrated with the clinician's own judgement, and with individual patient needs and preferences. In summary, more ‘clinician-friendly’ CPGs are necessary. This aspect of CPG development has rarely been addressed and it is a major ESA goal to put the end-user clinician (without sacrificing methodological rigour) at the centre of the efforts. To provide solutions to some of these challenges, the ESA Guidelines Committee, together with the ESA Board of Directors and the National Anaesthesiologists’ Societies Committee (NASC), has decided to implement several changes in the ESA CPG development process. Increase the number of guidelines so that more and more fields and aspects of our specialty are covered. This is probably best done by synergising with the Guidelines Committees of the 39 national anaesthesiology societies (NAS) that are part of NASC and also with the subspecialty societies that collaborate with the ESA. The models of collaboration are in the process of definition and each CPG will be based on a specific memorandum of understanding (MOU). The advantages of such synergy are numerous, not only in terms of a potentially increased numbers of CPGs that can be developed with the available budgets, but also in terms of quality, diffusion and harmonisation. Collaboration among NAS and subspecialist societies will be encouraged to enforce the strength and the acceptance of the guidelines, and to reduce redundancies and inconsistencies. Streamline the challenges of ‘clinician-friendly’, systematic, independent, transparent and auditable CPGs. With these goals in mind, a number of relevant aspects of guideline development, presentation and diffusion need to be assessed, discussed and followed for the production of future guidelines. Asking the right question is an essential step in providing the right answer The ESA will encourage and support the development of CPGs that best fulfil clinicians’ expectations. Specific attention will be paid to the way questions and recommendations are formulated so that solid methodology serves (i.e. does not ‘sacrifice’) clinical relevance. Accordingly, ESA policy will focus on planning only CPGs that are ‘really needed’ with a definite perspective and clear scopes and achievements. It is important to define whether a CPG is intended to correct/improve poor practice or change a clinical approach or policy. In the ESA, an enhanced connection between different committees (guideline and scientific committees), scientific subcommittees and national societies through NASC, will ensure from the available scientific evidence the definition of the real needs of clinicians that can find answers, and not add more doubts. In a sequential process, which starts with a clear description of the overall objective(s) and definition of the clinical question(s) covered by the guideline, the interventions of interest and the outcomes that may be affected if the CPG is implemented will be described. Different kinds of CPG can be developed; each type is characterised by a specific methodology and time required for its development, dissemination, implementation and update. Over recent years, the ESA has produced not only CPGs which, with the aim of completely covering a domain of knowledge/practice, included recommendations related to many aspects of that specific domain, such as the guideline on management of severe perioperative bleeding,1 but also guidelines focused on a clinical controversy, such as the guideline on perioperative fasting.2 The latter is a shorter text, which is easier to read, faster to develop, and with a higher probability of successful dissemination and implementation. These considerations bring us to the question of whether it is more useful to develop a comprehensive large CPG or a shorter, more focused one. Very few CPGs have been easily translated into clinical practice, resulting in suboptimal adherence. This is mainly because of the difficulties in implementing the recommendations, and to the perception by clinicians about the utility of a guideline in itself, which has ambiguous medicolegal significance even if based on strong evidence, application is not compulsory, although guidelines can assume a normative role in legal debates.3 Efforts are mandatory to improve CPG acceptability by clinicians and implementation in the ‘true clinical world’. Accordingly, future guidelines will be supplemented with dedicated ‘apps’ with condensed guideline content. Because many CPGs have recommendations based on weak evidence that requires clinical reasoning on evaluating the risk/benefits of interventions applied to an individual patient, future CPGs will be accompanied by e-learning modules that explicitly address clinical reasoning adapted to them. Recent evidence suggests that clinical reasoning is a necessary component of patient safety.4 The ESA Guidelines Committee agrees with that conclusion. Production of CPGs on a few relevant, defined, controversial or previously unaddressed questions, which can be developed in an acceptable period of time, and followed by e-learning modules, could enhance acceptance, adherence and diffusion, improve standards of care and patient safety, and partly cover the high costs of guideline development. Evaluation of the evidence The validity of any CPG depends strongly on the quality of evaluation of the existing evidence. This is essential for a CPG to be trusted by clinicians and implemented in clinical practice. Correct literature searches and skilful weighting of each relevant study, not biased by the confidence of randomised controlled trials (RCTs) and systematic reviews being superior to other types of studies and evidence, are crucial.5 Quality of evidence influences the extent to which we can trust a specific recommendation, and a guideline is only as good as the evidence on which it is based. However, clinicians need also to be confident that following a recommendation will do more good than harm, in other words, it is important to evaluate the strength of recommendations. As preliminary steps of CPG development, the following important aspects need to be evaluated: identification of the patients to whom the CPG applies; the clinical setting and the options to be compared; existence of scientific evidence that can guide the recommendations; other recommendations/CPGs that cover the same issue; definition of the target users; budget; timelines and who should be involved. The correct definition of the questions addressed by a CPG is fundamental to the evidence-based decision-making process, and strongly influences the recommendations. Questions will drive evidence search. A ‘well built’ question should include four parts, referred to as PICO, that identify the patient problem or Population, Intervention, Comparison, and Outcome(s).6 Experts of the task force are asked to pay particular attention to this first step, which has important implications in respect of the ability of a CPG to be accepted and implemented. Too broad a set of questions may generate heterogeneous evidence, which will be difficult to interpret. Also important for the task force is the choice of the most important outcome, and this may differ in emphasis among the different CPG end users. Outcomes should accordingly be rated and defined.7 This is a cornerstone moment to which great attention should be given. Questions raised will govern the literature search and give a first frame to the future recommendations; the number of questions will ensure a manageable size and adequate focus of the future CPG. In this phase, it is important to concentrate on the controversial aspects and on the interventions where changes are welcome, resisting the temptation to be comprehensive. Assessment of risk of bias by a systematic approach with incorporation of widely accepted tools to grade the recommendations such as Preferred Reporting Items of Systematic reviews and Meta-Analyses (PRISMA) and CONsolidated Standards Of Reporting Trials (CONSORT) statements, Cochrane risk of bias tool and Grading of Recommendations, Assessment, Development and Evaluation (GRADE) should be applied by guidelines authors.8–10 When underlying evidence suffers from systematically flawed methodology and bias because of poor-quality studies that often overestimate the intervention effects, there is still a risk of flawed and weak recommendations from using tools such as GRADE and Appraisal of Guidelines for REsearch & Evaluation (AGREE).11–13 However, these tools will help CPG task force members in reporting literature and offering standardised procedures to report trial findings transparently and fully, thereby aiding their critical appraisal and interpretation. One major issue that may undermine the validity of guidelines is our trust in the published literature and peer-review process, which cannot be taken for granted as quality assurance. Unfortunately, our field has suffered from serious setbacks recently because of scientific fraud, and fraud in the peer-review process.14 Accordingly, grading evidence merely on the publication label (i.e. the superiority of systematic reviews over RCTs, and RCTs over observational studies) exposes task forces to risks of developing flawed and false recommendations. Correct implementation of tools such as PRISMA and GRADE to assess the impact of bias may help restore our trust in the peer-review process and the published literature.11,12 These tools are vigorously promoted by the ESA and should be mandatory in order not to expose CPGs to likely criticism of the evaluation and presentation of evidence. The ESA requests that the GRADE approach is used.8,12 GRADE is an internationally accepted method for making transparent recommendations using a well defined methodology to grade the strength of recommendations and the quality of underlying evidence. Implementation tools should be part of the CPG. Implementation of the recommendations is probably the part of the CPG process that has received the least attention. The ESA Guidelines Committee will require that all future CPGs be developed with (at least some) tools for implementation although this may, of course, require on-site adaptation. All previously exposed new measures, especially the ‘end-user’ approach, are intended to facilitate implementation. Transparency of guideline development The clear methodological principles outlined above together with a distinguished expert task force and a clear policy of disclosure of conflicts of interest (COI) are basic tenets. A crucial aspect is the selection of the members of the task force. The number of experts should be less than 10 to maximise efficiency, selected on the basis of transparent, recognised and public criteria. All members will actively participate in the development of the CPG to be qualified as a co-author in accordance with the Vancouver criteria.15 A controversial issue for the task force constitution is the COI disclosure. COI can be described both as direct financial interests with entities that have direct interests in products or services relevant to the topic of the guideline, and indirect interests related to issues such as academic advancement, intellectual attachments to specific points of view or emphasis of an individual's own research. It is difficult to avoid some COI that could potentially influence the quality of a CPG and its acceptance, especially when, as stated above, it is mandatory to have a task force with recognised expertise in the field. If our broad definition of COI is accepted, it may be impossible to gather experts without some COI. Moreover, it should be underlined that the other participants in CPG development, such as other healthcare professionals, patients and policymakers may also have a COI.16 There are no widely accepted methods for updating CPGs.17 Criteria for updating are based on fixed/variable delays (2 to 4 years); availability of new evidence and a requirement for extended/new recommendations from new evidence. Each criterion has advantages and inconveniences. Given the effort required to develop methodologically solid CPGs, the ESA Guidelines Committee has decided to adopt a strategy of CPG updating based on the following principles. Creation of the task force of a of well experts in the domain of the CPG for a preliminary evaluation of the followed by an to other members of the task force on the basis of will give the future CPG a of enhanced scientific and and together with and acceptance, being as an intellectual of experts also within the The ESA Guidelines Committee should guide and the of the task force and not only evaluate who have applied to an but also identify any who do not the best scientific field a potential of validity and in of the task force. 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