Comparative Analysis of Clinical Practice Guidelines for the Pharmacological Treatment of Type 2 Diabetes Mellitus in Latin America

Identification and Characteristics of the CPGs

The strategy identified 404 publications. Thirty-one papers meeting the selection criteria were found in the open search. Forty-six references that met the selection criteria were screened. Finally, 36 documents were discarded because they did not refer exclusively to the management of T2DM, or because they corresponded to duplicate references or older versions of an updated guideline. Although the Dominican Republic and Panama were prioritized a priori, no guidelines were found to have been developed in these countries. After reviewing duplicates and previous reviews, a total of 10 guidelines for the management of T2DM were selected and evaluated with the AGREE II tool (Fig. 1). The pharmacological recommendations were extracted for each Latin American guideline selected, obtaining a total of 128 recommendations. They were classified according to the patient group stipulated in the protocol.

The most recent versions of each CPG were chosen, finding one guideline published before 2010, one from 2015, one from 2016, and the remaining seven guidelines between 2017 and 2020 (Table 1). Sixty percent of the CPGs were prepared by the Ministry of Health or whoever acts in its stead, while the remaining percentage was prepared by a group of experts from different entities in each country. In Honduras, for example, international entities contributed to its preparation.

Table 1 Overall characteristics of the Latin American Type 2 Diabetes Guidelines identified Evaluation of the Quality of the CPGs of the Countries

The median percentage of CPG evaluation by the AGREE II instrument (Table 2) ranged from 29 to 96%. It is important to mention that for CPGs that exceed a median evaluation percentage of 60%, their features were all above 80% in their weighted percentages of the domains (Table 3).

Table 2 Domain scores and general evaluations of diabetes guidelines considered as reference guidelines and of the selected countries, according to AGREE IITable 3 Descriptive statistics of the AGREE II score obtained by each CPGDomain 1. Scope and Objective

This domain refers to the general purpose of the guideline, the specific health aspects, and the target population. The mean of the evaluation was 81% (range 39–100%). In this domain, 6 CPGs scored over 80% (Argentina-Chile-Colombia-Ecuador-Honduras-Mexico).

Domain 2. Stakeholder participation

This domain refers to the degree to which the guideline has been developed by those involved in the preparation and it represents the point of view of users. Stakeholders are all people who contributed to the preparation of the guideline, whether from a methodological (epidemiologists), clinical (all health personnel who see patients with diabetes), consumer (patient), economic ambit among others. The mean for evaluation was 73% (IQR 14–100). In this domain, six CPGs scored over 80% (Argentina-Brazil-Colombia-Ecuador-Honduras-Mexico).

Domain 3. Rigor in Preparation

This domain refers to the process used to gather and synthesize evidence, the methods used to formulate recommendations and to update them. The mean of the evaluation was 68% (range 14–95%). In this domain, six CPGs scored over 80% (Argentina-Brazil-Colombia-Ecuador-Honduras-Mexico).

Domain 4. Clarity of presentation

This domain refers to the language, structure, and format of the guideline. The mean evaluation was 80% (range 56–94%). In this domain, six CPGs scored over 80% (Argentina-Brazil-Chile-Ecuador-Honduras-Mexico).

Domain 5. Applicability

This domain refers to the possible barriers and facilitating factors for its implementation, strategies to improve its adoption and the implications of the application of the guideline on resources. The mean evaluation was 57% (range 6–96%). In this domain, four CPGs scored over 80% (Argentina-Colombia-Honduras-Mexico).

Domain 6. Editorial independence

This domain is related to the formulation of recommendations not being biased by conflicts of interest. The mean of the evaluation was 73% (range 0–100%). In this domain, seven CPGs scored over 80% (Argentina-Brazil-Chile-Colombia-Ecuador-Guatemala-Honduras-Mexico).

Global Evaluation of Guidelines

In the global evaluation of the CPGs, which contemplates the six domains evaluated, six guidelines were classified as strongly recommended (Argentina, Brazil, Colombia, Ecuador, Honduras, Mexico). Three CPGs are recommended with modifications (Chile, Costa Rica, Guatemala). Only one CPG is not recommended (Peru), as none of the domains scored > 60%.

In the overall score of the guideline, three CPGs (Costa Rica, Guatemala, and Peru) had a score of < 4 points (2, 4, and 9).

General Recommendations and by Country According to the Improvement Needs of Each of the Guidelines

In the case of the Honduras CPG, of 67 treatment recommendations proposed by the ADA, 15 recommendations coincided and only one differed. For the Mexican CPG, 19 treatment recommendations were found, three of which coincide with the ADA recommendations.

The Honduran CPG is the one with the highest methodological quality profile developed in Latin America, where the general objectives of the guidelines are specifically described. There is stakeholder participation, rigor in its preparation, clarity in its presentation, applicability in its context, and editorial independence.

The CPG developed in Brazil could be improved in the description of the general objectives and stakeholder participation. Although the rigor in its preparation is good, it does not consider procedures for its updating, which detracts from its quality. Regarding to clarity of presentation, the key recommendations could be better highlighted to make them more identifiable. Improving their barriers and facilitators for implementation is a key factor, as well as are the tools on how the recommendations can be put into practice. This guideline has the necessary editorial independence.

The Peruvian CPG is the least methodologically rigorous of those developed in LA, and its improvement is essential in all respects, including the description of the general objectives, stakeholder participation, the rigor of its preparation, the clarity of its presentation, its applicability in its context and its editorial independence.

In the Mexican CPG, the general objectives of the guideline are specifically described, there is participation of stakeholders which could be complemented with a larger group of professionals and include more perspectives of the target population, a greater description of the population, the rigor in its preparation is satisfactory, as well as the clarity of its presentation. It is important to provide a greater description of barriers and facilitators to increase applicability in its context, and its editorial independence is highlighted.

Comparison of reference CPG recommendations and country recommendations

The Latin American guidelines were compared, and it was found that none of the guidelines evaluated consider the elderly population in their treatment recommendations, unlike the reference guideline that contemplates differentiation for each of the defined profiles. Additionally, only the Honduras guideline has a recommendation on patients with T2DM who have renal complications. Three guidelines (Colombia-Honduras-Costa Rica) consider pharmacological therapy in patients with overweight; six guidelines (Honduras-Mexico-Peru-Ecuador-Costa Rica-Argentina) made recommendations based on the presence of cardiovascular disease or risk in the patients with T2DM. However, only the Argentine guideline recommends the use of an SGLT2 inhibitor in patients with established cardiovascular disease. Four guidelines (Ecuador-Peru-Costa Rica-Honduras) recommend the use of aspirin in all patients with coronary artery disease or cardiovascular risk who present T2DM. The Honduras guideline is the only one that considers patients with dyslipidemia and T2DM. Only four guidelines (Mexico-Colombia-Argentina-Honduras) made recommendations based on the risk of hypoglycemia.

Most of the guidelines (Colombia-Chile-Mexico-Brazil-Ecuador-Argentina-Honduras-Costa Rica) made recommendations based on the inadequate glycemic control of patients despite having received previous oral antidiabetic therapy. All of them recommend the use of triple therapy in patients with adequate glycemic control. It is noteworthy that Ecuador is the only guideline that recommends the use of glibenclamide associated to metformin in the event that glycemic control is not achieved. Only three guidelines (Colombia-Ecuador-Mexico) gave recommendations for patients who persist with elevated HbA1 levels despite prior treatment with oral hypoglycemic agents. Colombia and Mexico recommend combination therapy with a DPP-4 or SGLT-2 inhibitor in this patient profile. Seven guidelines (Honduras-Ecuador-Chile-Argentina-Costa Rica-Mexico-Guatemala) characterized the recommendations according to insulin therapy. All guidelines except the Honduran guideline recommend initiating therapy with NPH insulin (intermediate insulin) compared to insulin analogs. The Honduran guideline recommends starting with slow-acting insulins instead of NPH since they have been shown to be effective in reducing the risk of symptomatic nocturnal hypoglycemia.

In general, gaps are found in medication profiles and uses. Only seven recommendations for the use of insulin were found in all the CPGs consulted in six countries: Argentina, Brazil, Colombia, Ecuador, Honduras, and Mexico. Except for the Ecuadorian CPG, all the others considered the use of GRADE for the recommendation; the strength that endorsed the recommendation for the use of insulins was heterogeneous with no influence of possible conflicts of interest in all the recommendations given (Table 4).

Table 4 Recommendations alluding to the use of insulin in the CPGs consulted

Regarding patient values and preferences, no information was obtained for most of the countries. Three countries reported a benefit/cost analysis that supports the recommendation of the use of some drugs, where two of them considered an increase in costs in the treatment with GLP-1 analogs justified by the benefit of the patients with this medication and in the cases in which the use of insulin analogs is not feasible. The CPG from a third country indicated no evidence of a beneficial effect of long-acting analogs on the mortality, morbidity, quality of life, or costs outcomes. Only two CPGs were found that considered aspects of feasibility, acceptability, and equity that support the recommendation. All the countries that gave recommendations regarding the use of insulins considered education for their use and/or the detection of hypoglycemia (Table 5).

Table 5 Considerations regarding the use of insulin in the CPGs consulted

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