Abstract
Aims:
Address treatment burden and general perceptions of pharmacological treatment in patients with diabetes.
Methods:
We surveyed adult patients with diabetes cared for in a tertiary academic medical center about: i) knowledge about the impact of glucose-lowering medication use on diabetes control and complications, ii) common beliefs about natural medicine and insulin use, iii) attitudes towards glucose-lowering medications, iv) burden of treatment, v) general knowledge of diabetes pharmacological treatment, and vi) perceptions of shared decision-making.
Results:
Two hundred-four participants completed the survey. While most (90%) agreed that adherence to medication would control diabetes and improve quality of life, 30–40% were not certain that it would translate to fewer disease complications. About one of three thought medications could be harmful (29.4%). Over 50% agreed or was unsure that natural remedies were as good/better than prescribed medications. About 30% acknowledged difficulties taking their diabetes medications and monitoring blood glucose, and over 50% were concerned about treatment costs. Nearly 30% denied receiving a detailed explanation from their clinician regarding their disease and is treatment.
Conclusions:
Our results highlight the importance of patient education regarding pharmacological treatment for diabetes, and eliciting sources of distress and treatment burden among patients with diabetes.
Keywords: diabetes, shared decision-making, burden of treatment, patient reported outcomes, medication adherence, financial burden
INTRODUCTION
Worldwide, diabetes is a major cause of morbidity, mortality, and impaired health-related quality of life. [1,2] A multifaceted treatment approach (e.g. control of blood glucose, blood pressure, dyslipidemia, smoking, obesity, etc.) is required to reduce the risks of diabetes complications and death. [3] Glycemic control, in particular, is fundamental to diabetes management and can be achieved with intensive lifestyle therapy and use of glucose-lowering medications, including insulin. [4–7] Unfortunately, adherence to glucose-lowering medications is poor. A recent systematic review reported treatment adherence to be variable across studies, ranging from 38.5% to 93.1%, where only 22% of the included studies reported an adherence rate of ≥80%. [8] Improving medication adherence is therefore a priority for clinicians and health systems.
Many factors can influence a patient’s ability to adhere to treatment recommendations, ranging from their general knowledge about the disease to sociocultural factors, family influences, economic situation, and treatment burden. When these factors are positively aligned (optimal environment, positive family influences, favorable economic situation, low treatment burden, high disease knowledge, etc.), they improve medication adherence. Conversely, poor disease knowledge, high treatment burden, psychological impairment, and a low economic situation can impede adherence. [9,10]
Despite a rapidly growing evidence base regarding the efficacy of glucose-lowering medications and the importance of medication adherence, little is known about how patients perceive and cope with their pharmacological treatment. A better understanding of the factors driving medication adherence and treatment burden may help clinicians engage in shared decision-making about glucose-lowering regimens, develop treatment plans that are acceptable and manageable for patients, and ultimately improve patients’ glycemic control, quality of life, and health outcomes. To address this important knowledge gap, we examined how patients with diabetes perceive the benefits and risks associated with glucose-lowering therapy, their knowledge about the impact of glucose-lowering therapy on risk of complications, and their self-reported treatment burden associated with the use of glucose-lowering medications.
METHODS
Setting and participants
This cross-sectional study was conducted using a structured, online questionnaire administered to patients seen in an Endocrinology, Internal Medicine, and Family Medicine Clinics located at an academic tertiary medical center in Monterrey, México. Participants were recruited in a consecutive fashion before or after their routine medical checkups. Adults aged 18 years or older with a diagnosis of type 1 or type 2 diabetes who were treated with at least one glucose-lowering medication were included. Participants with cognitive impairment or language barriers who were unable to comprehend verbal and written instructions were excluded from study. For participants with visual impairment, the study survey was read aloud by one of the study members and the provided answers were recorded. This study was approved by the local institutional ethics and research committee.
Study survey and design
The electronic survey instrument was designed by the study team drawing upon relevant literature, previously validated questionnaires, and discussions with subject matter experts with vast experience treating patients with diabetes. [11–14] Survey questions were iteratively refined by co-investigators, revised, and ultimately unanimously approved prior to implementation. The survey was pilot tested by three patients who met criteria for study enrollment but were not part of the study to ensure survey clarity and understanding. Patients’ recommendations for revisions were implemented, resulting in the final survey. (Appendix 1)
The survey evaluated the following: i) their knowledge about the impact of glucose-lowering medication use on diabetes control and diabetes complications, ii) common beliefs about natural medicine and insulin use, iii) attitudes towards glucose-lowering medications, iv) burden of treatment-related to diabetes, v) general knowledge of the disease pharmacological treatment, and lastly, vi) participants perceptions of shared decision-making between them and their clinician. It was divided in two sections. In the first section, clinical and demographical characteristics were obtained (age, gender, highest education level completed, weight and height, type of diabetes diagnosis, years since diabetes diagnosis, family history of diabetes). In the second section, we included 33 statements describing patients’ perceptions of the benefits and risks of pharmacological treatment of diabetes (11 questions), beliefs about natural medicine (e.g. ginseng, moringa) and insulin use (5 questions), attitude towards their treatment for diabetes (2 questions), burden of treatment (8 questions), and general knowledge of pharmacological treatment of diabetes (7 questions), to which patients rated their level of agreement using a 3-point Liker scale (disagree, neutral, agree). Furthermore, three questions of multiple-choice answers about shared decision-making between the patient and clinician were also included in this section.
Statistical analysis
Summary statistics were calculated as means (standard deviations), medians (interquartile ranges), and frequencies (percentages). Analyses were conducted using SPSS Statistics version 24 (Armonk, NY).
RESULTS
Clinical and demographic characteristics
We approached 232 potential participants and 204 accepted the invitation to participate in the survey (88% acceptance rate); all are included in the analyses. Mean age of participants was 55.7 years (SD, 12.9), 62.7% were women, and 73.5% had less than a high school education. (Table 1) The vast majority (82.4%) were either overweight or obese. Nearly 83% of patients reported a family history of diabetes. More than half (51%) were not aware of their diabetes type.
Table 1:
Demographic and clinical characteristics
| Age (mean, SD) | 55.7 (12.9) |
| Age (groups) (n, %) | |
| 0–20 years | 3 (1.5) |
| 21–40 years | 20 (9.8) |
| 41–60 years | 111 (54.4) |
| 61–80 years | 67 (32.8) |
| >80 years | 3 (1.5) |
| Female gender (n, %) | 128 (62.7) |
| BMI (mean, SD) | 30.2 (6.3) |
| BMI (groups) (n, %) | |
| Underweight | 8 (3.9) |
| Normal weight | 28 (13.7) |
| Overweight | 66 (32.4) |
| Type 1 obesity | 59 (28.9) |
| Type 2 obesity | 22 (10.8) |
| Morbid obesity | 15 (7.4) |
| School degree (n, %) | |
| Without studies | 28 (13.7) |
| Elementary School completed | 64 (31.4) |
| Middle School completed | 58 (28.4) |
| High School completed | 25 (12.3) |
| Bachelor’s Degree completed | 29 (14.2) |
| Type of diabetes (n, %) | |
| Diabetes type 1 | 15 (7.4) |
| Diabetes type 2 | 85 (41.7) |
| Does not know | 104 (51) |
| Years of diagnosis (mean, IQR) | 10 (4.8 – 18) |
| Family history of diabetes (n, %) | 169 (82.8) |
SD: standard deviation; IQR: Interquartile Range; BMI: Body Mass Index
Perceived benefits and risks associated with pharmacological treatment of diabetes
Most participants agreed that taking their prescribed medication would help them control their diabetes (88.7%) and improve their quality of life (91.7%). When asked about the impact of their medication on preventing microvascular (blindness, kidney disease, neuropathy) and macrovascular (myocardial infarction, stroke) complications of diabetes, 60–70% responded that they believed that the medications prescribed to them would prevent these complications. However, 29.4% noted that they expected their medication to cause frequent episodes of hypoglycemia and 28.4% believed it to be a collateral side effect that must be endured and cannot be avoided. Additionally, one in three of participants expected their medications to cause additional harm other than hypoglycemia. (Table 2)
Table 2:
Questionnaire on the perception of benefits and risks, knowledge, beliefs, attitudes, and burden of pharmacological treatment
| In disagreement | Not sure | In agreement | |
|---|---|---|---|
| Perception of benefits and risks of pharmacological treatment | |||
| Using the medicine my doctor prescribes will help me control my disease. | 18 (8.8) | 5 (2.5) | 181 (88.7) |
| Using the medicine my doctor prescribes to treat my diabetes will aid in preventing me from going blind due to the disease. | 41 (20.1) | 29 (14.2) | 134 (65.7) |
| Using the medicine my doctor prescribes to treat my diabetes will help me prevent from getting end-stage kidney disease or needing dialysis. | 40 (19.6) | 26 (12.7) | 138 (67.6) |
| Using the medicine my doctor prescribes to treat my diabetes will help me prevent having a heart attack from the disease. | 31 (15.2) | 43 (21.1) | 130 (63.7) |
| Using the medicine my doctor prescribes to treat my diabetes will help me prevent from having a stroke. | 34 (16.7) | 46 (22.5) | 124 (60.8) |
| Using the medicine that my doctor prescribes to treat my diabetes will help me prevent the development of diabetic foot. | 35 (17.2) | 22 (10.8) | 147 (72.1) |
| Using the medicine my doctor prescribes to treat my diabetes will help me prevent feeling pain and / or burning on my feet. | 42 (20.6) | 35 (17.2) | 127 (62.3) |
| Using the medicine my doctor prescribes to treat my diabetes will help me improve my quality of life. | 7 (3.4) | 10 (4.9) | 187 (91.7) |
| If I use the medicine that my doctor prescribes for diabetes, I will have low blood sugar (hypoglycemia) very frequently. | 116 (56.9) | 28 (13.7) | 60 (29.4) |
| Low blood sugar (hypoglycemia) is a side effect that must be endured. | 123 (60.3) | 23 (11.3) | 58 (28.4) |
| Using the medicine prescribed by my doctor could harm my health. | 114 (55.9) | 20 (9.8) | 70 (34.3) |
| Beliefs about drug treatment | |||
| The natural medicine that exists for diabetes is just as good or better than the medicines that my doctor prescribes. | 93 (45.6) | 45 (22.1) | 66 (32.4) |
| Natural medicine can cure my diabetes completely. | 145 (71.1) | 23 (11.3) | 36 (17.6) |
| The insulin and / or medications I take damage my kidneys. | 79 (38.7) | 41 (20.1) | 84 (41.2) |
| The insulin and / or the medications I take cause blindness. | 128 (62.7) | 40 (19.6) | 36 (17.6) |
| When someone is prescribed with insulin it means that they are in the final or a very advanced stage of diabetes. | 91 (44.6) | 31 (15.2) | 82 (40.2) |
| Attitudes towards drug treatment | |||
| I believe that the treatment prescribed by my doctor is the best option for my health. | 16 (7.8) | 14 (6.9) | 174 (85.3) |
| Following my diabetes treatment makes me feel better and more confident on a day-to-day basis. | 14 (6.9) | 1 (0.5) | 189 (92.6) |
| Burden of drug treatment | |||
| It is uncomfortable having to take / inject diabetes medicine at times when I am busy at work / school. | 120 (58.8) | 17 (8.3) | 67 (32.8) |
| I am always worried that I forget to take / inject my medicine at the right time. | 79 (38.7) | 8 (3.9) | 117 (57.4) |
| Measuring glucose (sugar) at home is very difficult. | 124 (60.8) | 17 (8.3) | 63 (30.9) |
| I feel guilty when I miss or forget to take a dose of medicine. | 79 (38.7) | 11 (5.4) | 114 (55.9) |
| The financial burden of diabetes treatment distresses me. | 82 (40.29) | 12 (5.9) | 110 (53.9) |
| The financial cost of my diabetes treatment distresses me. | 80 (39.2) | 9 (4.4) | 115 (56.4) |
| My diabetes treatment significantly affects my social life and my relationships with other people. | 152 (74.5) | 7 (3.4) | 45 (22.1) |
| Treating my illness makes me feel like I am a burden to my family. | 121 (59.3) | 6 (2.9) | 77 (37.7) |
| General knowledge about drug treatment | |||
| If diabetes is not under control with a drug at the maximum dose, another drug or insulin needs to be added to your treatment. | 42 (20.6) | 21 (10.3) | 141 (69.1) |
| If the sugar level is under control, you can stop taking the medicine. | 118 (57.8) | 12 (5.9) | 74 (36.3) |
| If I feel fine, I can stop taking my diabetes medicine, even if my blood sugar is high. | 186 (91.2) | 4 (2) | 14 (6.9) |
| Treatment for diabetes is life-long. | 16 (7.8) | 14 (6.9) | 174 (85.3) |
| I can eat whatever I want if I am on my diabetes medicine. | 147 (72.1) | 7 (3.4) | 50 (24.5) |
| I don’t need to exercise if I am on my diabetes medicine. | 178 (87.3) | 9 (4.4) | 17 (8.3) |
| If I take / inject my diabetes medicine my blood sugar levels will go down, even if I only do it sometimes. | 129 (63.2) | 16 (7.8) | 59 (28.9) |
Common beliefs regarding pharmacological treatment of diabetes
The majority of patients either agreed with or were not sure whether natural remedies were as good or better than their prescribed glucose-lowering medications (54.5%), and many believed that they could cure diabetes permanently (28.9%). Additionally, 61.3% of survey respondents either agreed or were not sure on that insulin could damage their kidneys, and 37.2% agreed or were not sure on that it could cause blindness. A total of 55.4% agreed or was not sure on that if a patient with diabetes required insulin, that signified they were in the final and most advanced stage of the disease. (Table 2)
Attitudes towards pharmacological treatment
The vast majority of participants believed that their prescribed medications were the best thing for their health (85.3%) and that adhering to their treatment made them feel better and safer in their everyday life (92.6%). (Table 2)
Burden of treatment
Nearly 33% of participants stated that it was uncomfortable to take/inject their diabetes medication during busy times and that monitoring their blood glucose at home was difficult for them. More than half expressed constant worry about forgetting to take their prescribed medication at the proper time (57.4%) or feeling guilty when they did forget to do so (55.9%). Furthermore, more than half were worried about medication and how they will be able to afford to continue to obtain their medications). A total of 22.1% of respondents felt that diabetes affected their social life and relationships with other people and 37.7% felt like a burden to their family because of their disease. (Table 2)
General knowledge about diabetes pharmacological treatment
Only 8.8% of participants agreed with the statement that they could discontinue a glucose-lowering medication if they felt well but their blood glucose level was elevated. However, if their blood glucose was under control, 36.3% agreed that they could discontinue their medication. Most participants knew that diabetes was a life-long disease (85.3%) and were aware that they had to follow specific dietary and lifestyle habits as part of their treatment regimen. However, 24.5% of participants also believed that they could eat whatever they wanted if they were compliant with their medications and 28.9% believed that blood glucose levels would normalize with pharmacological treatment even if these medications were taken sporadically. (Table 2)
Perception of Shared Decision Making.
Seventy percent of participants reported receiving detailed information about their disease from their clinician, including a discussion of the benefits and risks of the specific medications they were treated with. Among these patients, 60.8% endorsed adequate understanding, and 9.8% endorsed partial understanding of the clinician’s explanation during these conversations. Overall, 72.5% of participants reported being explained what “optimal diabetes control” means and only 39.7% noted that their clinician offered them different treatment options, while the remainder indicated that the clinician chose their medication without seeking the patient’s input.
DISCUSSION
People living with diabetes have mixed feelings about their diabetes medications, partly because of inadequate knowledge about the likely benefits and harms of treatment, with evidence of impact on treatment burden. Indeed, the vast majority of patients with diabetes treated with glucose-lowering medications believed them to improve their quality of life and reduce risks of both microvascular and macrovascular complications. However, they also anticipated their glucose-lowering medications to have significant side effects, including hypoglycemia (about 1 in 3 participants). For insulin, in particular, many believed it could lead to kidney disease or cause blindness. These data underscore the importance of improving patient/clinician communication and shared decision-making about glucose-lowering therapies, as misconceptions about the benefits and harms of treatment may worsen adherence, increase treatment burden, and impair quality of life.
Participant responses revealed important gaps in understanding the pathophysiology of diabetes and its optimal management. For example, 54.5% of them either agreed or were not sure whether natural medicine was as good or even better than their prescribed medication. They also overestimated both the benefits and harms of their medications. We believe this to be related to sociocultural influences and clinicians not adequately educating patients on their disease. Patient misinformation could lead to harmful practices that could be deleterious for their health in both the short and long term. This can be rectified through better conversations between patients and clinicians, facilitated shared decision-making (such as through use of validated decision aids), and engagement of Certified Diabetes Care and Education Specialists (CDCESs) in the patient’s care. Earlier work has found that patient misconception, misinformation, and lack of knowledge about their medications are among the main factors that lead to treatment discontinuation and lack of metabolic control. [15] Conversely, patient education correlates with higher treatment satisfaction levels and better adherence to it. [16,17] Poorly adherent patients are more likely to report worries about medication side effects, doubt medication efficacy, report self-consciousness factors that could interfere with treatment, and experience higher rates of hypoglycemia. [17] Therefore, providing patients with adequate information is a key component for optimal diabetes care and may promote better attitudes and self-care practices [18], ultimately resulting in better treatment adherence and metabolic control.
Despite the importance of diabetes education, only 60% of participants reported receiving and understanding education on the benefits and risks of their treatment from their clinician. This is important, as patients who do not receive adequate information from their clinicians will seek it on their own [19], and it may not be accurate or pertinent to them. The majority of participants also did not endorse engaging in shared decision-making with their clinicians. Thus, to improve diabetes management and health outcomes, more emphasis needs to be placed on patient education, informed and shared decision-making, and screening for knowledge and understanding.
Treatment burden is defined as “the impact of health care on patients’ functioning and well-being, apart from specific treatment side effects”. [20] Patients with diabetes often face complex treatment regimes, require ongoing medical attention, invest economic resources on their treatment as well as meet physical and emotional demands. [21–23] In our study, we also observed a significant amount of treatment burden, especially regarding the economic costs of treatment. This may be driven by the fact most patients in our hospital have low to middle incomes and are more affected than wealthier patients by high medication costs. Treatment burden, low household income, high out-of-pocket expenditures for medications [17,24], psychological impairment, and treatment burden all lead to worse adherence. [22, 25–27] Treatment burden is therefore important to both elicit from patients and to adequately address. Yet, video graphic analysis of clinical encounters between patients with diabetes and their clinicians, Bohlen et al. revealed that while treatment burden is discussed in 93.5% of encounters, efforts to address it were rarely undertaken, representing missed opportunities for reducing rate of treatment discontinuation. [28] In our survey, nearly 4 in every 10 participants agreed on that their disease treatment made them feel like a burden to their family, and 25% agreed that diabetes significantly affected their social life and relationship with other people. Comparable to our findings, Nicolucci et al. reported in a survey of patients with diabetes that 40% of them reported their medication interfered with their ability to have a normal life. [29] It is important for clinicians to be aware of the treatment burden that could accompany diabetes and to actively inquire for factors that could increase distress among patients.
A strength of this study includes the involing a population often excluded from studies yet in need of better engagement. Still, some limitations should be acknowledged. This was a single academic-center study, therefore our findings may not be generalizable to all people living with diabetes and the selected population was not random, which could introduce selection bias and affect results accuracy. The questionnaire was not statistically validated, leaving its reproducibility in question. Finally, we did not perform a power estimation to determine the sample size, as such, the precision of our results could be uncertain. Also the generalizability of our results is uncertain, as scarce literature on this topic is available on future studies should be performed to provide more clarity.
Our findings are, however, informative for low and middle income patients with lower educational attainment, and provide an evidence base for patient populations commonly excluded from prior research. In conclusion, a great proportion of patients living with diabetes lacks adequate understanding regarding their disease, treatment effect and risks and reported having burden of illness and treatment Herein, our results highlight the importance of patient education regarding pharmacological treatment for diabetes, of the use of shared decision-making between patients and the clinicians, and not to assume, but rather to directly bring to light situations that could lead to increased distress and treatment burden in the patient. Taking all these factors into consideration is vital in the process of providing holistic and patient-centered diabetes care that can hopefully translate not only into a reduced risk of diabetes complications, but also into helping patients have a better quality of life and achieve their goals and life expectations.
Supplementary Material
DECLARATIONS
Conflict of interest:
None. Dr. McCoy advises Emmi® on the development of diabetes-related education materials and has received support from NIDDK, PCORI, and AARP®. This effort was funded in part by the National Institute of Health (NIH) National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) grant number K23DK114497 (RM). NSO was supported by the National Cancer Institute of the National Institutes of Health under Award Number K08CA248972. SM was supported by the Arkansas Biosciences Institute, the major research component of the Arkansas Tobacco Settlement Proceeds Act of 2000, and by the United States Department of Veterans Affairs Health Services Research & Development Service of the VA Office of Research and Development, under Merit review award number 1I21HX003268-01A1. Study contents are the sole responsibility of the authors and do not necessarily represent the official views of NIH, the Department of Veterans Affairs, or the United States Government.
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