**1. Introduction**

Venous thromboembolism (VTE) is a complex multifactorial disease influenced by acquired or inherited predispositions to thrombosis, environmental exposures, and the interaction between them, and can manifest as deep vein thrombosis (DVT) or pulmonary thromboembolism (PTE) [1].

The average annual incidence is approximately 1 per 1000 in the adult population, with a higher incidence rate in men than in women. The incidence increases after the age of 45, reaching a rate of 5 or 6 per 1000 inhabitants annually in the elderly over 80 years [1–3].

Approximately 50% of thrombotic events occur during or shortly after hospitalization, with 24% in surgical patients and 22% in medical patients [1]. PTE accounts for 5-10% of hospitalized patient deaths, making VTE the most common cause of preventable deaths in hospitalized patients, and thromboprophylaxis is an important strategy to improve patient safety in hospitals [4].

Clot formation during hospitalization, surgical procedure, or health care is known as hospital-acquired thrombosis and can occur during hospitalization and up to 90 days after discharge [4]. In addition, VTE is associated with recurrence, postthrombotic syndrome, chronic pulmonary hypertension, and bleeding due to anticoagulation [1, 5, 6]. These complications substantially contribute to patient morbidity and the cost of management [4].

Although national and international consensus is available, studies show that 50% of at-risk patients do not receive adequate prophylaxis [7]. According to these consensuses for the prevention of VTE induced in hospitals, should take into account the risk factors for the occurrence of an event, the benefits of available prophylactic agents, possible complications, and the cost of treatment, information that should be part of a formal hospital strategy supporting the decision of the professionals involved [8, 9].

Clinical Practice Guidelines (CPGs) are tools that contain recommendations on clinical health interventions, with the aim of improving patient care, based on a systematic review of evidence to assess the benefits and harms of different therapeutic alternatives in health care [10, 11].

The Institute of Medicine (IOM) defines CPGs as "statements that included recommendations, intended to optimize patient care, informed by a systematic review of evidence and an assessment of the benefits and harms of alternative care options". CPGs are underpinned by systematic review evidence and are usually formulated by groups of stakeholders with relevant domain expertise [12].

One way to obtain the CPGs is through adaptation. The ADAPTE Collaboration, an international collaboration of researchers, guideline developers, and guideline implementers, has developed a systematic approach tool for adapting guidelines considering the organizational and cultural environment to application in a different context. In this way, it is possible to take advantage of existing guidelines and produce high-quality adaptation [13].

*Methodological Quality of Clinical Practice Guidelines for Pharmacological Prophylaxis… DOI: http://dx.doi.org/10.5772/intechopen.103660*

The use of an instrument to assess the quality of guidelines, the Appraisal of guidelines research and Evaluation (AGREE II), is recommended during the guidelines decision and selection tasks that take place within the adaptation process by the ADAPTE methodology. From the selected CPGs, summaries of recommendations are created, allowing the visualization of whether the recommendations from different CPGs are similar or different, verifying which of these have strong evidence and providing the clinical importance of each one of them [14, 15].

Therefore, the aim of this study was to analyze the methodological quality of CPGs for pharmacological VTE prophylaxis in adult hospitalized medical and surgical patients; and to summarize the main categories of the recommendations included in high-quality CPGs.

#### **1.1 Adaptation of clinical practice guidelines**

Adaptation of guidelines is a systematic approach to modify guidelines produced in a cultural place and organizational setting to be applicable in another context [16]. The adaptation is an alternative to the development of a new guideline preserving the principle of evidence-based practice [17].

The ADAPTE collaboration is a group of researchers, guideline developers, and guideline implementers who proposed a systematic approach to adapting guidelines that ensure the elaboration of final recommendations and that address specific health issues adapted to the context of use, meeting local needs, priorities, legislation, policy, and resources [16].

The process is divided into 3 main phases, set up, adaptation and finalization, with 24 steps divided into 9 modules [13]. **Figure 1** demonstrates a summary of the processes.

The Set-up phase is described in 6 steps. At this stage, it must be verified whether the adaptation is feasible, tracking the availability of guidelines in specific repertoires to proceed with the adaptation process. A working group must also be defined with the activities to be developed by each member for the selected topic. All members must have their tasks well described and must sign the conflict-of-interest term. At this stage, it must also be defined how the consensus for decision-making among the members will be carried out, which must be described in the final document. All stages of the set-up phase must be described in the adaptation plan [11, 13, 16].

In the adaptation phase, the clinical questions that guide the search for CPGs must be defined. The search must be carried out with the elaboration of the clinical question. For this purpose, an acronym can be used, for example, PIPOH: Population, Intervention, Professional, Outcome and Health care setting, which allows for defining the clinical question by addressing the aspects necessary for the development of a welldefined search strategy, being able to identify relevant guidelines in databases and guideline-specific repositories, websites of guideline development organizations and specialized societies [11, 13, 16]. **Table 1** describes the components of the acronym.

The quality of the selected guidelines can be evaluated by the AGREE II (http:// www.agreetrust.org)instrument,through the 23 items that make up the tool, and evaluate the guideline development method. In addition to quality, experts should be aware of the guidelines' update dates and check whether the recommendations have undergone changes that may impact the adaptation of the CPGs [11, 13].

Another factor to be evaluated is the content of the guidelines, through the extraction of recommendations, with their levels of evidence that must compose the matrices and can be grouped by guideline or by similarity [13].

#### *Anticoagulation - Current Perspectives*

#### **Figure 1.**

*Summary of the adaptation process from the description of the ADAPTE tool. ADAPTE collaboration (2009) was prepared and adopted by the author [13].*


#### **Table 1.**

*Description of the PIPOH acronym for the elaboration of the clinical question ADAPTE collaboration (2009) prepared and adapted by the author [13].*

The recommendations help the end-user of the CPGs by describing what should be done to make an appropriate decision in certain situations and optimize patient care to improve the health outcome both individually and collectively [13].

The acceptability and applicability of recommendations to the target context depend on the adaptation to variables such as availability and organization of health services, resources, beliefs, and values of the population. All details of the process must be recorded in a draft document [11, 13].

In the finalization phase, the external review process by users must take place. Thus, all comments received must be evaluated by the elaboration group that proceeds with the modification of the guideline, if pertinent. Every process must also be documented. At this stage, the guideline update plan should also be considered. With all the prerequisites defined, the final version can be produced and deployed [13].

#### **1.2 Quality assessment of clinical practice guidelines**

Adaptation involves the step of critically evaluating the methodological quality of the CPGs for the selection of high-quality guidelines, determined by confidence in how potential biases in the elaboration process were addressed and by verifying the validity of recommendations for clinical practice considering the risks, benefits, and costs [11, 13].

The first version of the Appraisal of Guidelines Research and Evaluation (AGREE) was published in 2003 by the AGREE collaboration, a group of international guidelines developers and researchers, with the aim of obtaining a tool for assessing the quality of CPGs. The evaluation included a judgment of the methods used to develop the guidelines, the components of the final recommendations, and the factors that are linked to their implementation. The instrument was translated into several languages and quickly became accepted as a gold standard tool for guideline evaluation. It has been tested in 11 countries in more than 100 guidelines and with more than 200 evaluators, being endorsed by the World Health Organization, the Council of Europe, and the Guideline International Network (GIN). The revised version was published in 2009 [15].

All 23 items on the instrument are scored on a Likert scale from one to seven, where one is "strongly disagree" and seven is "strongly agree". Scores between 2 and 6 are assigned when the item does not meet all criteria and considerations [15]. In this way, each domain is scored according to the dimension of quality addressed as described in **Table 2**.


The quality score is calculated for each of the six domains independently, which receives a score ranging from 0 to 100%. The calculation is performed by adding the

#### **Table 2.**

*Domains of the AGREE II instrument. AGREE next steps consortium (2017), prepared and adapted by the author [15].*

scores of the individual items and calculating the maximum and minimum scores that the domain could receive depending on the number of evaluators, with at least two being indicated [15]. The calculation of the score for each domain does not indicate that one domain is more relevant than the other. The AGREE II manual also does not set a limit to distinguish between high- and low-quality CPGs [18, 19].
