Diabetes mellitus (DM) is a complex multisystemic disease that requires high quality care, increases the risk of potentially life-threatening complications, and imposes a high impact on healthcare services and a heavy economic burden on society [
The pathogenesis and long-term metabolic and vascular complications of type 2 diabetes (T2DM) are fairly well known but its treatment has remained challenging, with only half of the patients achieving the recommended HbA1c target, and a significant proportion of the diabetic population still do not receiving adequate care [
To address these issues, this study was designed with the primary objective of assessing factors involved in adherence to CPGs on T2DM diabetes. Secondary objectives were to identify major barriers preventing adherence to main CPGs and to develop a document with conclusions regarding actions for improving adherence to guidelines, which will finally contribute to a more effective care of patients with T2DM.
This was a cross-sectional multicenter study based on a two-round Delphi survey (the IMPLICA study). IMPLICA is the Spanish acronym for “Factores IMPLicados en el seguimiento de las guías de páctIca Clínica en diAbetes” (factors involved in adherence to clinical practice guidelines in diabetes). The study was conducted over two 3-month periods (first Delphi round from April to June, 2020; second Delphi round from August to October, 2020). The study protocol was approved by the Ethics Committee for Clinical Research of Hospital Clínico San Carlos, Madrid (Spain).
A panel of three clinically active specialists in endocrinology, metabolism, and nutrition with special interest and large experience in the care of patients with diabetes was recruited to form the scientific committee of the study. They were responsible for the development of the study questionnaire and supervision of the progression of the study, including the recruitment of participants, coordination of the analysis, and interpretation of data. The content and topics to be included in the study questionnaire were designed by the scientific committee based on their experience and a comprehensive search of the literature to identify previously conducted studies with high level of evidence and key primary studies focused on the care of subjects with 2TDM and, particularly, on CPGs and adherence to recommendations.
Study participants were experienced practicing specialists in endocrinology, metabolism, and nutrition attending a minimum of 10 patients with T2DM every week in either public or private institutions throughout Spain. Participants were recruited through formal e-mail invitations that included a brochure with full information about the project. Participation in the study was anonymous. The questionnaire was lodged in an Internet microsite that could be accessed via a weblink included in the brochure. Only physicians who accepted to participate in the study were provided with access to the questionnaire microsite URL and the user’s password. Participation in the study was anonymous and voluntary.
The final questionnaire emerged from a two-round Delphi consensus process and was composed of 8 sections with a total of 43 items. Section
For each item of the study questionnaire, the mean value of the five possible responses in the 5-point Likert scale was calculated. A consensus was established in favor of the recommendation when the sum of responses “strongly agree” (Likert score 5), and “moderately agree” (Likert score 4) was greater than 75% of the total responses obtained for that item. By contrast, a consensus against the recommendation was reached when the sum of responses “strongly disagree” (Likert score 2) and “moderately disagree” (Likert score 1) was greater than 75% of the total responses for that item. When none of these previous assumptions were met, a consensus for or against the statement was not reached. Since this was a qualitative rather than a quantitative study, the number of selected participants based on the probabilistic error was not established [
A total of 98 endocrinologists (40 men, 58 women) with a mean (SD) age of 44.9 (9.2) years (range 29-65) agreed to participate in the study. They had been practicing for a mean (SD) of 16.0 (9.5) years. Almost all participants (90.8%) worked in public hospitals (tertiary care hospitals in 75%) located in urban areas (99%), with a median of 9 endocrinologists working in their services. Participation in a training program on diabetes and in a research program in the previous 12 months was reported by 78.6% and 53.1% of participants, respectively. Also, 67.3% reported that they had attended between 76 and 150 patients in the last week, and that more than 25% of patients were diagnosed with T2DM according to 69.4% of participants.
All participants used CPGs in the care of patients with T2DM, with the American Diabetes Association/European Association for the Study of Diabetes (ADA/EASD) recommendations as the most commonly used guideline (99%), followed by the document of integral approach of T2DM of the Spanish Society of Endocrinology and Nutrition (SEEN) by 79.6%, the American Association of Clinical Endocrinologists/American College of Endocrinologists (AACE/ACE) comprehensive type 2 diabetes management algorithm by 38.8%, the recommendations for the pharmacological treatment of hyperglycemia in T2DM of the Spanish Society of Diabetes (SED) by 34.7%, the T2DM in adults: management NICE by 10.2%, and the Clinical Practice Guidelines for the Prevention and Management of Diabetes in, Canada, Professional Section of Diabetes Canada by 8.2%. As shown in Figure
Factors related to not following recommendations of CPGs (scored from
Consensus was achieved in 7 of 10 items included in this section (percentages of agreement from 80.2% to 98%) (Table
Factors related to clinical practice guidelines (CPGs).
Items of the questionnaire | Total number | Number of responses (%) | ||
---|---|---|---|---|
Disagree (moderately disagree/strongly disagree) (Likert 1-2) | Neither agree nor disagree (Likert 3) | Agree (moderately agree/strongly agree) (Likert 4-5) | ||
(i) The evolution of the research, given that sometimes there are subsequent findings that are proven uncertain or irreproducible, may reduce the credibility of the CPG recommendations | 96 | 20 (20.8) | 5 (5.2) | 71 (74.0) |
(ii) The complexity of the process recommended in the CPG difficults adherence | 96 | 48 (50.0) | 6 (6.3) | 42 (43.8) |
(iii) Scientific advances organized in the form of guidelines and recommendations are an invaluable help for clinicians | 98 | 2 (2.0) | 2 (2.0) | 94 (95.9) |
(iv) The objective of the guidelines is to provide an up-to-date informative framework that helps the clinician to make the most appropriate decisions individually for each patient | 98 | 3 (3.0) | 1 (1.0) | 94 (95.9) |
(v) The dynamic nature of scientific knowledge implies the periodic reassessment of the CPGs | 98 | 2 (2.0) | 0 | 96 (97.9) |
(vi) An effective dissemination of the CPGs and their updates is necessary | 98 | 2 (2.0) | 0 | 96 (97.9) |
(vii) There are different CPGs whose recommendations do not coincide | 96 | 13 (13.6) | 6 (6.3) | 77 (80.2)† |
(viii) Although a guide is well implemented it is difficult to maintain it, since after a certain time professionals tend to return to their previous routines | 96 | 66 (68.8) | 6 (6.3) | 24 (25.0) |
(ix) It is crucial to incorporate adherence indicators to the CPGs | 96 | 4 (4.2) | 6 (6.3) | 86 (89.6)† |
(x) The large number of CPGs on diabetes may prevent effective dissemination | 96 | 6 (6.3) | 4 (4.2) | 86 (89.6)† |
Participants agreed that limitations established by the healthcare system prevent adherence to CPGs (75%), and that differences in local administrative regulations between autonomous communities have a different impact on adherence (90.9%) (Table
Factors related to the healthcare system and the healthcare center.
Items of the questionnaire | Total number | Number of responses (%) | ||
---|---|---|---|---|
Disagree (moderately disagree/strongly disagree) (Likert 1-2) | Neither agree nor disagree (Likert 3) | Agree (moderately agree/strongly agree) (Likert 4-5) | ||
Healthcare system-related factors | ||||
(i) The limitations to the prescription established by the public healthcare system prevent treatment according to the CPG | 96 | 18 (18.7) | 3 (6.3) | 72 (75.0)† |
(ii) Differences in administrative limitations of local authorities between autonomous communities may have a different impact on adherence to CPGs | 98 | 4 (4.1) | 5 (5.1) | 89 (90.9) |
(iii) Recommendations of international CPGs generally do not coincide with the current situation of our healthcare system | 96 | 45 (46.9) | 10 (10.4) | 41 (42.7) |
Healthcare center-related factors | ||||
(i) The clinician does not have enough time in the care of his/her patients to follow some recommendations | 96 | 4 (4.1) | 3 (3.1) | 89 (92.7)† |
(ii) There are no adequate material resources for the diagnosis and treatment recommended in the CPG | 96 | 30 (31.3) | 14 (14.6) | 52 (54.2) |
(iii) There are not adequate human resources for the diagnosis and treatment recommended in the CPG | 96 | 10 (10.4) | 3 (3.1) | 83 (86.5)† |
As shown in Table
Factors related to diabetes and the clinician.
Items of the questionnaire | Total number | Number of responses (%) | ||
---|---|---|---|---|
Disagree (moderately disagree/strongly disagree) (Likert 1-2) | Neither agree nor disagree (Likert 3) | Agree (moderately agree/strongly agree) (Likert 4-5) | ||
Diabetes-related factors | ||||
(i) The complexity of the pathology makes it difficult to be compliant with the CPG | 96 | 61 (63.5) | 11 (11.5) | 24 (25.0) |
(ii) The risk of hypoglycemia continues to be a limiting factor for the comprehensive control of patients with diabetes | 96 | 12 (12.5) | 4 (4.2) | 80 (83.4)† |
Clinician-related factors | ||||
(i) Therapeutic inertia means that despite knowing the CPG recommendations, the clinician continues with his previous practice | 96 | 12 (12.5) | 4 (4.2) | 80 (83.3)† |
(ii) The constant updates of the CPGs make it difficult to be up to date and have a deep knowledge of them | 96 | 28 (29.2) | 8 (8.3) | 60 (62.5) |
(iii) Professionals must handle complex pharmacological treatment, which is perceived as a difficulty for intensification | 96 | 24 (25.0) | 12 (12.5) | 60 (62.5) |
(iv) The lack of connection between all the members of the interdisciplinary team that manages diabetes makes access to new agents and combined therapies difficult | 96 | 23 (23.9) | 10 (10.4) | 63 (65.6) |
(v) It would be necessary to have the support of dietitians and podiatrists in the management of patients with T2DM | 98 | 1 (1.0) | 3 (3.1) | 94 (95.9) |
(vi) The insufficient number of nursing personnel with specific training in diabetes education makes it difficult to approach patients with T2DM | 98 | 2 (2.0) | 2 (2.0) | 94 (95.9) |
In this section of 7 items, consensus was achieved in only 2 (28.6%) (Figure
Factors related to the patient preventing adherence to recommendations of CPGs (5-point Likert scale; agree: moderately/strongly agree (scores 4-5), disagree: moderately/strongly disagree (scores 1-2).
Finally, there were no statistically significant differences in the responses obtained according to the participant’s age of ≤40 years (
This two-round Delphi study was conducted to explore the level of adherence to CPGs for T2DM by Spanish endocrinologists and to identify barriers associated with nonadherence. Different characteristics of participants enhance the value of their responses, including a wide range of age (mean 45 years), large experience (mean 16 years), tertiary care hospitals from the public health care system and large specialized services (median 9 endocrinologist) as the working setting, and high percentage of endocrinologists who reported participation in training programs of diabetes and research projects during the last year. These characteristics may explain the fact that 100% of participants were aware and used CPGs in daily practice, with ADA/EASD recommendations as the most commonly used by almost all of them, followed by recommendations of the SEEN, the AACE/ACE, and the SED. Other CPGs (NICE and Diabetes Canada) were used by only around 10% of participants. Interestingly, lack of time, individualized patient management, and insufficient human resources were three important reasons to account for nonadherence to CPGs on the endocrinologist perspective.
Although many studies have addressed compliance with metabolic and biochemical targets, blood pressure, healthy diet, physical exercise, or therapeutic recommendations in retrospective and prospective cohorts of subjects with T2DM [
From the perspective of intrinsic features of guidelines, there was a consistent agreement on the advantages of their use, particularly, to support appropriate decisions in individual patients, the need to update information regularly, and the importance of incorporating adherence indicators in the CPGs. In relation to factors associated with clinicians, consensus was achieved regarding insufficient human resources with support on the part of nursing personnel, dietitians, and podiatrists, as well as the risk of hypoglycemia as a limiting factor for the control of patients and the negative role of therapeutic inertia. Therapeutic inertia impairs the ability of to attain and maintain glycemic targets, which in turn increases risks for the development and progression of diabetes-related complications. Therapeutic inertia has been identified as an important contributor to failure to advance or deintensify treatment, although in a broader concept clinical inertia includes also issues such as failure to screen, make appropriate referrals, and manage risk factors and complications [
In a study to assess adherence to German treatment guidelines for T2DM with the participation of 46 experienced physicians, they had a consistent perspective on the value of the national treatment guidelines, but perceived patient inability and demotivation to be the strongest adherence barriers [
The present results should be interpreted taking into account the observational and exploratory nature of the survey based on self-reporting, reflecting the subjective perception of the participants. However, the number of participants was almost 100, and all of them were endocrinologists with a solid experience in type 2 diabetic patients care; so, the survey was able to capture a broad set of perspectives of adherence barriers related to the guidelines, healthcare system, physicians, and patients. It is, to our knowledge, the first assessment of physician perspective on T2DM guideline adherence in the Spanish-speaking area.
Nonadherence to CPGs on T2DM is a multifactorial problem but the existence of multiple CPGs, the lack of time, the therapeutic inertia, and the complexity of diabetes has been identified as factors limiting adherence. Hypoglycemia continues to be a barrier for achievement of targets recommended by CPGs. Increasing the number of healthcare professionals in the multidisciplinary teams (diabetes specialist nurses, dietitians, and podiatrists) is necessary in providing good patient care and promoting adherence to CPGs.
The data used to support the findings of this study are available from the corresponding author upon request.
The authors declare that they have participated as speakers and meetings supported by Novo-Nordisk as well as advisory boards with Novo-Nordisk.
All authors participated in the development of the study protocol, study questionnaire, discussion of the results, and drafting of the manuscript. All authors have seen and approved the final manuscript.
The authors thank Grupo Saned, S.L., for logistic and statistical support and Marta Pulido, MD, PhD, for editing the manuscript and editorial assistance. This study was founded by Novo Nordisk España, Madrid, Spain.