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. 2021 Mar 4;16(3):e0247952. doi: 10.1371/journal.pone.0247952

The magnitude of non-adherence and contributing factors among adult outpatient with Diabetes Mellitus in Dilla University Referral Hospital, Gedio, Ethiopia

Bisrat Desalegn Boshe 1, Getachew Nenko Yimar 2, Aberash Eifa Dadhi 3, Worku Ketema Bededa 4,*
Editor: Claudia Marotta5
PMCID: PMC7932062  PMID: 33661976

Abstract

Introduction

The global prevalence of Diabetes Mellitus (DM) has increased alarmingly over the last two decades. On top of this, the issues of non-adherence to the prescribed medicines further fuel the DM- related complications to become one of the top causes of mortality and morbidity. Despite the considerable efforts in addressing the poor adherence issues, there are still plenty of problems ahead of us yet to be addressed. The objective of this study was to determine the extent of non-adherence and its contributing factors among diabetic patients attending the medical Referral clinic of Dilla University Referral Hospital.

Methods

The institutional-based descriptive cross-sectional study was carried out among patients with diabetes mellitus attending the medical referral clinic of Dilla University Referral Hospital.

A systematic random sampling method was used to recruit study participants, and tool was adopted to assess for adherence. A pretested semi-structured questionnaire was used to collect information on factors influencing non-adherence to the diabetic medications, and in-depth interview questionnaire was used for key informant interviews for the qualitative part. Data analysis was carried out using SPSS-20.

Results

The overall prevalence of non-adherence to diabetic treatment regimen among the study participants was 34.0%. The study revealed that cost of transport to the hospital and taking alcohol were significantly associated with non-adherence to the diabetic treatment regimen with the (AOR = 6.252(13.56, 28.822); p < 0.000) and (AOR = 13.12(8.06, 44.73); p<0.002) respectively.

Conclusions

The study revealed that significant numbers of participants were non-adherent to the Diabetes Mellitus treatment regimens. Intensive counseling, and health education on the importance of good adherence and negative consequences of poor adherence need to be discussed with the patients before starting the medications, and amidst follow up.

1. Introduction

The leading endocrine disorder, Diabetes mellitus, is characterized by an abnormal metabolism and an inappropriately raised amount of serum glucose due to either absolute shortage of insulin or reduced tissue responsiveness to insulin [1].

The total number of people who will be affected by diabetes is expected to be 366 million cases by the year 2030. The rate of increment of this disease is immense in developing countries because of changes in lifestyle over the last few years. The region is being affected by the dual effects of non-infectious diseases like DM and infectious diseases, yet with the problems of accessibility to health care, and treatment [2,3].

Even though data regarding the prevalence of Diabetes Mellitus in active Tuberculosis is not sufficient in our country, literatures in other countries show the significant burden of Diabetes mellitus among active Tuberculosis with negative health outcomes. The problem is more worrisome in the developing countries where Tuberculosis is endemic, and the expected prevalence of Diabetes Mellitus is increasing alarmingly [4,5].

Diabetes Mellitus is the most important cause of both mortality and early infirmity; in the United States, it is the leading cause of blindness among working-age adults, end-stage renal disease, and non-traumatic limb amputations. It also increases the risk of cardiac, cerebral, and peripheral vascular disease two- to seven-fold and is a major contributor to neonatal morbidity and mortality and in the obstetric setting. Most of the overwhelming complications of diabetes can be prevented or delayed by the proper treatment of increased blood glucose levels and other modifiable risk factors. In treating diabetes, the timing of therapy is fundamental as the early recognition and treatment of the disease decides the clinical outcome [2,3,6].

In Africa, up to 80% of diabetic patients are underdiagnosed, and appearing to the health care facilities with complications is not uncommon. The chronic nature of the disease without symptoms will contribute for the late presentations. For some, poverty is the main reason for not to appear at Hospitals and take medications [7,8].

In Ethiopia, the national data on prevalence and incidence of diabetes are unsatisfactory despite an increment in patient attendance rates and medical admissions in the major hospitals. The World Health Organization (WHO) projected the number of diabetic cases in Ethiopia by 2030 to about 1.8 million [9].

Apart from the poor health seeking behavior of the society, non-adherence to the management play a pivotal role in the development of diabetes related complications. If the patient is not a good adherent, complications like cardiovascular, renal, neurologic [6,10], and extra cost to the health care system [1113] will result. The cumulative global expenditure on the management of diabetes and its complications in 2013 was US$ 548 billion. In Africa, the cost per person with diabetes was US$ 208.07 (IDF, 2014a). This emphasizes the serious need of attention in the prevention and management of diabetes, and also addressing issues of non-adherence [1416].

In Ethiopia, the pervasive problems of economic instability, low educational background, and service unreachability to health care facilities might have played a significant role in the increased incidence of medication non-adherence. As far as our knowledge goes, the information on the level of non-adherence to diabetic treatment and the associated factors lacks in the study setting. We believe it was necessary to establish the factors that affect the adherence to the anti-diabetic treatment with the goal of improving the adherence and ultimately decreasing the incidences of diabetes complications.

2. Methodology

2.1 Study setting

The study setting was Dilla University Referral Hospital, Gedio zone, Southern Nation Nationality Peoples Regional State, Ethiopia. Dilla University Referral Hospital found in Dilla town that is located 365 km south of Addis Ababa, (the capital city of Ethiopia). The Hospital was established In 1928 G.C the Sudan Interior Mission (SIM) established a one block clinic in Dilla, Later in 1958 G.C, this clinic was upgraded and named ‘‘Leul Mekonnin Hospital” After 48 years of inception (in 1976 G.C) the missionaries handed the hospital over to the Ministry of Health (MOH). The hospital was upgraded to give services for 250, 000 population and inaugurated on January 30, 1985 G.C bearing the name ‘‘Dilla Rural Hospital’.’ June 2009 G.C, it has been transferred to the hands of Dilla University in accordance with the agreement signed between Dilla University and Gedeo Zone Administration.

Currently, it is under the college of medicine and health science of Dilla University that gives educational service for new innovative medical education program students, Emergency Surgery & Obstetric, Health Officer, Midwifery, Psychiatry, and Anesthesia together with clinical service to the community. The hospital gives services to about 5 million people in Southern part of Southern Nation Nationalities and People and Southern parts of Oromia and Somali. Now the hospital has 555 different workers who are functioning on different services, of which 335 are administration workers. The other 220 workers are health professionals.

2.2. Study design and population

Institutional based cross-sectional study was conducted in order to assess non-adherence to diabetic treatment regimen and factors associated with non-adherence to treatment regimen among diabetic out patients at Dilla University Referral Hospital who came for follow up at Diabetic and chronic care clinic.

2.3. Inclusion & exclusion

2.3.1 Inclusive criteria

Those patient diagnosed as diabetes mellitus in chronic follow-up for greater than three months Patients greater than 18 years Avail themselves during data collection time.

2.3.2. Exclusive criteria

Very ill patients/admitted inpatient were excluded, Patient age less than 18 years and Those who are in diabetic coma or mentally incompetents.

Gestational diabetes

2.4. Sample size determination

The sample size was calculated using single population proportion formula as follows

n=Z12P(1P)w2n=(1.95)20.5(10.5)(0.05)2
n=3.84×0.5×0.50.025=384

Where:

n = desired sample size for population >10,000.

Z = standard normal duration usually set as 1.96 (which corresponds to 95% confidence level).

P = we use positive prevalence estimated. To maximize sample size. Negative prevalence = 1–0.5 = 0.5.

W = degree of accuracy desired (marginal error is 0.05).

As there is no previous study on topic under study in the study area, to estimate prevalence a figure of 0.5 used to get the possible minimum large sample size.

Since the total population is<10,000 that is 318; we use the Correction formula to determine final sample size.

nf=n1+nN=nf=3841+384318=175

N = final sample size when a population is <10,000.

n = initial sample size when the population is >10,000.

nf = estimated study population.

Then 10% contingency was added on 175

175×10%=17.5=nf+contingency=191

2.5. Study design, participants, and sampling procedure

The institutional -based cross-sectional study was conducted in order to assess non-adherence to diabetic treatment regimens and factors associated with non-adherence to treatment regimens among diabetic outpatients. All diabetic patients who attend the medical referral clinics for treatment and follow up at Dilla University Referral Hospital were included. The study population consisted of all diabetic patients who attend the chronic illness clinics for treatment and follow up of Dilla University Referral Hospital during the study period were included. The single population proportion formula was used to calculate the sample size.

For the quantitative part, the study participants were recruited as they came to the clinic using a systematic random sampling technique with a sampling interval of every third patient. The sampling was done until 191 study participants were recruited. The choice of the first study participant was identified through random sampling by picking either the 1st or the 2nd patient by way of tossing a coin. Participants who met the inclusion criteria and willing to participate in the study were included. For the qualitative part, purposive sampling was used to select nurses and doctors as key informants from among nurses and doctors working at the diabetic clinic.

The quantitative data was collected using a pretested semi-structured questionnaire which was used. It was serialized and administer to the study participants with the help of 3 trained research assistants, a supervisor, and the principal investigator. The data included demographic characteristics, assessment of non-adherence, and reasons for non-adherence.

Adapted version of Morisky Medication adherence questionnaire was developed to evaluate non-adherence to diabetic treatment [17]. Based on the scores obtained 0 was considered high adherence, 1 or 2 as medium adherence, and >2 was low adherence. In this study, medium and high adherence were considered as adherent and low adherence as non-adherent for statistical purposes. The study participants were asked to recall whether they had missed any doses of any ant-diabetic medications on day to day basis over the last week. To increase accuracy on the number of pills prescribed, the study participants’ hospital files and previous prescriptions were reviewed. Study participants were investigated for reasons for non-adherence to diabetic treatments. For physical exercise and dietary assessment, whether the patient is doing regular exercise and follow dietary advice given by his treating physician, the treating physicians were sources of information.

The questionnaires were checked for completeness and reliability of responses manually. For the quantitative part, data were coded, entered in SPSS for windows version 20.0. Appropriate descriptive and analytical (Chi-square, OR, bivariate, multivariate) test was used to determine the prevalence of non-adherence and statistically significant association between the dependent variable and independent variables whereas for the qualitative part thematic approach was used. Results were presented in texts, graphs, and tables.

2.6. Study variables

2.6.1. Dependent variable

Non-adherence to Diabetes mellitus treatment.

2.6.2. Independent variables

Socio-demographic Variable.

  • Sex

  • Age

  • Religion

  • Marital status

  • Monthly income

  • Occupation

  • Social support

  • Educational status

Health service factor- patient related factors.

  • Distance from the hospital

  • Drug supply

  • Staff motivation

  • Diabetic education

Treatment factors.

  • Side effects

  • Duration treatment

  • Duration since diagnosis

  • Pill burden/ Run out of pills

  • Perception on the causes of diabetes

  • Perceived benefits of treatment

  • Perceived harm of treatment

  • Other chronic illness

  • Use of traditional medicine

  • Monitoring blood sugar level

2.7. Data quality assurance

The quality of data was assured by properly designed questionnaire, proper training of the interviewers and supervisors of the data collection procedures, proper categorization and coding of the questionnaire. Every day, 10% of the computed questionnaires are viewed and checked for completeness and relevance by the supervisors and principal investigator and the necessary feedback was offered to data collectors in the next morning before the actual procedure.

2.8. Ethical considerations

IRB of Dilla University had approved the ethical clearance. Based on the objective of the study an official letter was sent to Dilla University Referral Hospital that was involved in the study from Dilla University, College of Health Science Research and Publication committee prior to the data collection period. Verbal informed consent was obtained after briefing the objective of the study. Those who were willing to be interviewed were signed in the space provided. The minor groups were not included in our inclusion criteria. Confidentiality was maintained and all respondents’ questionnaire anonymously prepared S1 File.

3. Results

3.1. Socio-demographic and economic characteristics

A total of 191 diabetes mellitus patients were enrolled in this study, out of which 106(56%) were males and 85 (44%) were females. The mean age of the study participants was 55.4 (SD ± 12.85). Most 114(60.2%) of the study participants were aged between 40–59 years and a few 21(11.5%) were aged less than 40 years. About 63(33.5%) participants could only read and write and 55(29%) had attended grades 1–8 whereas 15.2%, 10.5% had no formal education and college/university respectively. More than 80% of the study participants were married and 13.2% were widowed with 4.2% divorced. The occupation section of the respondents indicates that 32.5%, 23%, and 23.6% of patients were housewives, government employees and private working respectively. About 3.1% and 3.7% were retired and student respectively. Approximately half of the study 49.2% participants earned less than five hundred Ethiopian birr per month.

More than half of the study participants, 122(63.9%), had social support. Among them, 52(42.6%) by a family member, 21(17.2%) by local edir and ekub, 18(14.8%) by the government workers like health extension workers, 16(13.1%) by faith- based organization, and the remaining 15(12.2%) were supported by the non-government organization Table 1.

Table 1. Socio-demographic and economic characteristics of T2DM patients who attend the medical referral clinics for treatment and follow up at DURH, 2017.

Variable Frequency Percent
SEX
Male 107 56.0
Female 84 44.0
Age (Years)
<30 18 9.4
30–40 35 18.4
41–50 50 26.2
51–60 73 38.2
>60 15 7.8
Religion
Orthodox 78 40.8
Protestant 68 35.6
Muslim 19 9.9
Catholic 23 12.0
others (specify) 3 1.6
Educational status
No formal education 29 15.2
Read and write 64 33.5
Grade 1–8 57 29.8
Grade 9–12 11 5.8
TVET 10 5.2
College/University 20 10.5
Marital status
Never married 3 1.6
Married 155 81.2
Widowed 25 13.1
Divorced 8 4.2
Occupation status
Government employee 45 23.6
Private working 44 23.0
Student 7 3.7
Merchant 27 14.1
House wife 62 32.5
Retired 6 3.1
Monthly income
<500 92 49.2
501–1000 36 17.8
1001–2000 27 14.1
>2000 36 18.9

3.2. Types of Diabetes Mellitus & perceived causes

About 173 (90.6%) of study participants were type II. More than half of reported patient perceptions on causes of diabetes were consuming sugary diets 56(29.3%), stress 33(17.3%), genetics 27(14.1%), eating fatty foods 27(14.1%), being overweight or obese 26(13.6%), inadequate physical activity 19(9.9%) and It is a punishment from God for past sins 3(1.6%). The perception of diabetic patients on Causes of diabetes mellitus was evaluated by the key informants as appropriate perception.

“Few patients relate it to consuming sugar diet especially the old generation but most of them don’t know what caused their illness.”

(Key informant 2 –doctor).

“Relatively a lot of our patients actually know and will tell you my ancestral related family members. So they know it is hereditary factor, genetic factor that contributes.”

(Key informant 4- doctor).

3.3. Magnitude of non-adherence to diabetic treatment regimen

The overall prevalence of non-adherence to diabetic treatment regimen among the study participants was 34.0%. About 73(38.2%) of the study participant do not follow either the dosing drugs or appointment according to the agreement with the treating physician. The major reasons participants ascribed to these were nothing should be swallowed during the fasting period, ant diabetic drugs are not necessary if sugary diets were not consumed, traditional medicine cure diabetes, prayers could cure diabetes and forgetfulness.

The majority, 166(86.9%), of the study participants do not conduct a regular exercise to standard. Most of the participant reported that lack of information (70.2%), shortage of time (17.8%), the difficulty of changing previous habits (6%), granting self-permission(4.2%), poor self-control(1.3%), and critical illness (5%) were the main reason non-sticking to the exercise. Regarding diet management 79.6% of the participant did not attend to their dietary intake according to the advice given by the managing physician due to lack of money to buy food (52.4%), lack of diet options (27.2%) economic reasons S1 Fig.

Adherence to diabetic treatment regimen was viewed by the key informants to be insufficient. Between 20% and 40% of the target population was said to be non-adherent.

“It is difficult to estimate in percent but I can say in general the adherence to diabetic treatment regimen is not good.”

(Key informant 1-doctor).

“Adherence is insufficient among patients attending our medical referral clinic. I would say 20% do not adhere and 80% adhere.”

(Key informant 2- doctor).

“I can say adherence is not a hundred percent. Those who adhere are 70% and those who don’t are 30%.”

(Key informant 3 –nurse).

3.4. Patient-related factors for non-adherence diabetic treatment regimen

The predominant patient- related reasons reported by participants for missing to take diabetic treatment regimen were, when away from home 154 (80.6%), when taking alcohol 148(77.5%), and any long-lasting comorbidity 117(61.3%) whereas few participants 6(3.1%) reported that they do take treatment when feeling better Table 2.

Table 2. Patient related factors for non-adherence to diabetic treatment regimen among T2DM patients who attend the medical referral clinics for treatment and follow up at DURH, 2017.

Variables Frequency Percent
Miss Rx when away from home 154 80.6
Miss Rx when take alcohol 148 77.5
Long lasting comorbidity 117 61.3
Miss Rx when symptom are controlled 50 26.2
Miss Rx when felt worse 35 18.3
Miss Rx when difficulty of remembering 26 13.1
Miss Rx when upset/depressed 29 15.1
Miss Rx when Busy 24 12.6
when did not understand 23 12
when feel better 18 9.4
when feel medication harm health 14 7.3
Miss when feel No benefit 6 3.1
Fear of Stigma 22 11.5

Most of the key informants quoted being away from home, change of habits, stopping to take medicine when they feel better, perceived lack of efficacy of the prescribed medicine, and forgetfulness as patient- related factor for non-adherence.

Most of chronic care patient particularly diabetic patients being away from home and change of habits mostly observed problems on follow up”

(Key informant 2- doctor).

“Some of the patients complain forgetfulness as the main reason for missing the ordered medication”

(Key informant 3-nurse).

“Some patient misses their drug when they feel better and when they think lack of efficacy of the prescribed medicine”

(Key informant 2- doctor).

3.5. Health care system and treatment-related factors

More than half 122 (63.7%) of the study participants resided at distant less than or equal to 10 km away from the facility and about 71(37.1%) live at distant more than 10km. About (49) 25.7% of the participant missed the appointment due to inability to afford the transportation cost. Almost half of the participants did not get their diabetic education from the treating physician and also about one-third of the participants 57(29.6%) had a strained relationships with health care providers. Near half of the study participants 102(53.4%) obtained their diabetic medication(s) from Dilla University Referral hospital pharmacy.

Approximately 152(80%) missed diabetic medicine due to they cannot afford and more than half 111 (58.1%) were on co-medication for long-term illnesses such as anti-hypertensive. A relatively high proportion, 128(66.8%) of study participants had at least one diabetes complication. About 11(6.0%) reported that they sometimes used traditional medicine for managing diabetes and again 26(13.6%) had experienced side effects like hypoglycemia.

About half of the study participants, 97(50.8%), were more than five years since the diagnosis and almost all of them 96(50.3%) has started diabetic treatment at the time of diagnosis confirmed. The majority, 183(95.8%), of the participant gets tested their blood sugar level Table 3.

Table 3. Distribution of study participants by duration since the diagnosis of diabetes mellitus among T2DM patients who attend the medical referral clinics for treatment and follow up at DURH, 2017.

Duration in year since Diagnosis Frequency Percent
< = 2 55 28.8
2–5 39 20.4
5–10 47 24.6
>10 50 26.2

Most of the key informants regarded occasional stock out of diabetic medication including diagnostic tests as major health system- related factors contributing to non-adherence to the diabetic treatment regimen.

” Some patients say the drugs and blood sugar tests are no available in the hospital occasional or expensive when it is available and others complain that they do not have money for transport and even for food.”

(Key informant 2—doctor).

“Few patients say their drugs got finished and were waiting for the next clinic, others say they had traveled upcountry while others think they are okay.”

(Key informant 3 –nurse).

3.6. Factors associated with non-adherence to diabetic treatment regimen

None of the socio-demographic and socio-economic characteristics was significantly associated with non-adherence to diabetic treatment regimen at (p>0.05). And also none of the patient perceptions on causes of diabetes mellitus was significantly associated with non-adherence to the diabetic treatment regimen (p> 0.05).

Alcohol usage, being away from home, being upset, feeling no benefit, stigma, and did not understand about treatment were statistically significant by bivariate analysis for COR at 20.02 (p < 0.000), 26.02(p< 0.000), 3.63(p<0.042), 2.68 (p<0.002), 4.04 (p<0.046) respectively. The rest of patient-related factors were not statistically significant (p > 0.05). Again the cost of transport to hospital and Side effect of treatment were statistically significant COR at 6.252 (p < 0.05) and 2.64 (p<0.042) respectively.

Variables from bivariate analysis with p ≤ 0.25 were fitted into the binary logistic regression model to identify factors independently associated with non-adherence to the diabetic treatment regimen. The variables included were being away from home, taking alcohol, feeling better, being upset, and cost of transport to the hospital. Using the stepwise forward likelihood ratio method, the variables cost of transport to the hospital and taking alcohol were identified as the predictors of non-adherence to the diabetic treatment regimen. Cost of transport to hospital was significantly associated with non-adherence to the diabetic treatment regimen (AOR = 6.252(13.56, 28.822). Taking alcohol was significantly associated with non-adherence to diabetic treatment regimen (AOR = 13.12(8.06, 44.73) Table 4.

Table 4. Association between variable understudy and non-adherence diabetic treatment regimen among T2DM patients who attend the medical referral clinics for treatment and follow up at DURH, 2017.

Variables Adherence level OR (95% CI)
Utia Adherent Non-adherent Cr COR(95% CI) A AOR(95% CI)
Alcohol usage ****
Yes 62(49.2%) 64(50.8%) 20(5.96,67.15) 13.12 (8.06, 44.73)
No 3(4.4%) 65(95.6%) 1.01 1 1
Being away from home
Yes 63(47.7%) 69(52.3%) 26(6,09–111.02)
No 2(3.3%) 57(96.7%) 1
Being upset
 Yes 18(60%) 12(40%) 1. 3.63 (1.62,8.14)
  No 65(33.6%) 128(66.6%) 1
No benefit
 Yes 10(55.6%) 8(44.4%) 2.68 (1.03,7.16)
 No 55(31.8%) 118(68.2%) 1
Fear of stigma
 Yes 14(63.6%) 8(36.4%) 4.04(21.60, 10.19)
 No 51(30.2%) 118(69.8%) 11 1
Did not understand about treatment
 Yes 13(56.5%) 10(43.5%) 2.90(1.19, 7.04)
 No 52(32.1%) 116(67.0%) 1
Lack money for transport
Yes 61(95.3%) 3(4.7%) 625.6.25(13.56,28.82) 62 6.25(13.5,28.82)
No 4(3.1%) 123(96.9%) 3.63 1 1
Side effect 2
Yes 11(55%) 9(45%) 2.64(1.03,6.76)
No 54(31.6%) 117(68.4%) 11 1

4. Discussion

In this study, there was high a prevalence of non-adherence to physical exercise and dietary regimen that is 86.9% and 79.6% respectively in comparison with adherence to ant diabetic medication. This is almost comparable with the studies carried out in Zimbabwe, Saudi Arabia, Mexico, and Hungary showed that 26%–85% of the study subjects did not follow the physician’s advice on exercise however, the instructions on diet were followed by 38%–76.8% of them [1821]. The reasons for non-adherence to diet recommendations could be lack of information, economic reasons, being away from home, Difficulty of changing previous habits, granting self-permission, and poor self-control. With regards to exercise, it could be attributed to lack of motivation, change in their habits, lack of information, exercise as potentially exacerbating illness, lack of exercise partner, and specific locations away from home.

The study has shown that, none of the social demographic characteristics were significantly associated with non-adherence to the diabetic treatment regimens. The findings are consistent with results from other studies from Zimbabwe and México [18,19]. The findings were in differences with studies carried out in Uganda [19,22] in which female gender was significantly associated with non-adherence to the diabetic treatment regimen and in South Western Nigeria [23] where gender and occupation were significantly associated with non-adherence to the diabetic treatment regimen. This might be a result of not adjusting for confounding factors for the Nigerian study. The findings also differed from those studies carried out in [21] Hawaii [24] and France [22,25] where adherence was strongly associated with age. Presumably, the differences in sample sizes, might attribute to the discrepancies.

The study revealed that, the financial problem in which approximately 92 (50%) of the participants with a monthly income of less than 500 Ethiopian birr was one of the main external challenges of adherence. This is close to a study done in Nigeria which was around 56.6%. In Ethiopia, the non-adherence is 37.1% which was due to financial difficulty [23,26].

The most commonly reported diabetic patient’s perceptions on causes of diabetes were consuming sugary diets, stress, genetics, eating fatty foods, being overweight or obese, and inadequate physical activity in the current study. The findings were consistent with those of other studies [10].

The Support provided by the family played a beneficial role in enhancing adherence, in our study around 42.6% was found while a similar result of 45.7% was found in another study The general finding from different research articles showed that patients who had emotional support and help from family members, or healthcare providers were more likely to be adherent to the treatment. [13,15]

In this study, it is also found that having social support have positively affected the adherence to diabetic treatment regimens. This finding is indifferent to the studies referred here [18,22]. This could be due to differences in lifestyles among populations in various countries whereby some could be more interrelated and supportive than others.

In this study, none of the patient perceptions on causes of diabetes mellitus were significantly (P > 0.05) associated with non-adherence to the diabetic treatment regimens in the current study. The finding was in line with a study carried out in Zimbabwe [18] but differs from a study conducted in the United Kingdom [27], this could have been due to differences in their socio-economic status.

Duration of having diabetes and long-standing other illnesses were not significantly associated with non-adherence to the diabetic treatment regimen in the current study. This finding is similar to the study done at around Jimma [28]. Duration of treatment, taking of traditional medicine, other medications for other long term illness, and side effects of the drugs were not significantly associated with non-adherence to diabetic treatment agent. The long duration of diabetes treatment greater than ten years was found to be significantly associated with non-adherence to oral hypoglycemic medications in a study conducted in Zimbabwe [18] which did not agree with the current study.

The health care system-related factors specifically the availability of diabetic medication, distance from health facility, patient-health care provider relationship, diabetic education, and high medication cost were not significantly associated with non-adherence to the diabetic treatment regimen. This finding was almost similar to the study carried out in Jimma [28] in regard to the distance from the health facility but different from a study conducted in Zimbabwe. [18] This could be due to the difference in socioeconomic variation between Ethiopia and Zimbabwe for accessibility of health service [29].

In the current study, the cost of transport to the hospital and taking alcohol were identified as the predictors of non-adherence to the diabetic treatment regimens. Cost of transport to hospital was significantly associated with non-adherence to the diabetic treatment regimen (AOR = 8.51; 95% CI: 5.63–36.03; P < 0.000). Taking alcohol was significantly associated with non-adherence to the diabetic treatment regimen. (AOR = 4.12; 95% CI: 1.26–8.73; P < 0.002). Taking alcohol will affect the timing, and also contributes to forgetfulness [19,23,30,31].

Conclusion

In this study, the overall prevalence of non-adherence to diabetic treatment regimen was substantial. Counseling the patients on the importance of adherence to the treatment is crucial.

Supporting information

S1 Fig. Showing the magnitude of adherence and non-adherence among the participants among T2DM patients who attend the medical referral clinics for treatment and follow up at DURH, 2017.

(PDF)

S1 File

(PDF)

Acknowledgments

The authors acknowledge all the respondents who took part in the study.

Data Availability

All relevant data are within the manuscript and its Supporting information files.

Funding Statement

This study was performed under the Ministry of Science and Higher Education and supervision of Dilla University College of Medicine and Health Sciences.

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Decision Letter 0

Claudia Marotta

Transfer Alert

This paper was transferred from another journal. As a result, its full editorial history (including decision letters, peer reviews and author responses) may not be present.

11 Jan 2021

PONE-D-20-36834

Assessing the Magnitude of Non-adherences to the treatment of DM and associated factors ; A hospital based Cross-sectional study

PLOS ONE

Dear Dr. Bededa,

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PLOS ONE

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dear authors follow reviewer suggestion to improve your paper

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Reviewer #1: Yes

Reviewer #2: No

Reviewer #3: No

**********

2. Has the statistical analysis been performed appropriately and rigorously?

Reviewer #1: Yes

Reviewer #2: No

Reviewer #3: Yes

**********

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Reviewer #1: Yes

Reviewer #2: Yes

Reviewer #3: No

**********

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Reviewer #2: No

Reviewer #3: Yes

**********

5. Review Comments to the Author

Please use the space provided to explain your answers to the questions above. You may also include additional comments for the author, including concerns about dual publication, research ethics, or publication ethics. (Please upload your review as an attachment if it exceeds 20,000 characters)

Reviewer #1: I read with great interest the paper. I find it well wrote on important topic.

Only some suggestion

1. Introduction: diabetes is a risk factor for onset infectious diseases (es tuberculosis) and to worst outcome. Please add information about this relationship and how they influence in worst each other (see and cite doi: 10.4314/ahs.v17i3.20. PMID: 29085405; PMCID: PMC5656213; doi: 10.1186/s13104-018-3209-9. PMID: 29402317; PMCID: PMC5800087T doi: 10.1111/tmi.12704. Epub 2016 May 18. PMID: 27102229.)

2. Methods and result well wrote

3. Discussion add how is not only important diagnosis but care diabetes especially in low setting (see and citeDiabetes in active tuberculosis in low-income countries: to test or to take care? Lancet Glob Health. 2019 Jun;7(6):e707. doi: 10.1016/S2214-109X(19)30173-1. PMID: 31097272)

Reviewer #2: The authors have made interesting observations in this study. Nevertheless, the study is demerited for several reasons as detailed in my comments below.

1. The study is not powered by a statistically calculated sample size as it has applied random sampling method. The observations of the study cannot be extrapolated to the general population due to it’s cross-sectional design.

2. The study was conducted in 2017 and is communicated to a journal in 2020. This is a major concern as it limits the validity of the results for the recent times. The sample size is 191 subjects. To conduct this study in a hospital setting should not have been time consuming. I am concerned for reasons in delay in conducting and completing the study.

3. The salient findings of the study as mentioned in the abstract do not add any novel dimension for further research. I do not find any significance except for the fact that it is reported from a hospital in Ethiopia.

4. The manuscript is badly formatted. It appears that the authors did not proof check the manuscript and did not adhere to neat formatting norms on Word document. The manuscript appears un-appealing to the reviewers.

5. The authors have used erroneous English with too many grammatical errors and incomplete sentences. For eg “ In the section on introduction the line “In Africa, up to 80 % of diabetic patients are underdiagnosed and will complicate” I am sure that this manuscript was not proof checked.

6. The reference for Morisky Medication adherence questionnaire has not been cited.

7. Though the tables 1 and 2 have been cited, they do not appear in the main PDF of the manuscript. The tables are badly formatted and do not appeal to the reviewers.

8. There are no foot notes below tables which indicate the lapse in correct presentation of results.

9. Figures 1 and 2 are shoddy and needless.

10. References are badly formatted and do not comply to the journal’s specifications.

11. References 1 is unsuitable for a citation.

12. In short, this is a shoddy presentation of cross-sectional study with no robust validation. It would not worthwhile to make technical comments for a manuscript which does not comply to the basic requirements of a scientific manuscript. The authors need to seriously review the standard of writing manuscripts before communicating them to an international peer reviewed journal of significant impact factor. In view of the comments above, I deem it unsuitable for publication in Plos One in the present form.

Reviewer #3: The present manuscript encompasses a diabetes mellitus disease and non adherence . There are many articles on this subject in the literature.

The present work needs a thorough revision in material and methods, results and discussion. Diabetes Mellitus Type 2 disease is extremely common amongst adults and the non adherence. Was this a case control study? the inclusion/exclusion criteria need more details. The status of Diabetes disease need to be determined by laboratory exams. These information can be shown in a descriptive table.

It is also not clear if the number of subjects included in the study is supported by sample size calculations, as both diabetes and non adherence are common in the general population. Can this subject size support your conclusions?

In summary, the study design needs to be revisited to improve its results and its relevance.

**********

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Reviewer #1: No

Reviewer #2: No

Reviewer #3: No

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Attachment

Submitted filename: Review comments.docx

PLoS One. 2021 Mar 4;16(3):e0247952. doi: 10.1371/journal.pone.0247952.r002

Author response to Decision Letter 0


4 Feb 2021

Manuscript PONE-D-20-36834

Point- by- Point Rebuttal Letter

We really thank the academic editor, and all the three reviewers for their valuable comments on our manuscript.

Please kindly find below our response to each point raised by the academic editor and reviewers. We hope that we clearly addressed all of them, and that the manuscript will be now appropriate for publication. We bolded the comments, and highlighted the responses by green color.

Sincerely,

On behalf of all the four authors,

Worku Ketema Bededa

Journal Requirements:

1.) Please ensure that your manuscript meets PLOS ONE's style requirements, including those for file naming.

� Thank you for your guide, and we have checked the templates and made the adjustments to meet the journal requirements.

2.) We note that your study uses the Morisky Medication Adherence Scale, which requires a license for use. Please include a short statement in your methods section to clarify whether you obtained a license to use the MMAS scale in your work, and whether the license was obtained prospectively or retrospectively.

� You raised important point, and since it is difficult to secure the license for MMAS, we developed a tool based on the contents of MMAS from study done by Boon-How Chew N-HH, Mohd-Sidik Sherina (17)

3.) Please provide additional details regarding participant consent. In the ethics statement in the Methods and online submission information, please ensure that you have specified (1) whether consent was informed and (2) what type you obtained (for instance, written or verbal, and if verbal, how it was documented and witnessed). If your study included minors, state whether you obtained consent from parents or guardians. If the need for consent was waived by the ethics committee, please include this information.

If you are reporting a retrospective study of medical records or archived samples, please ensure that you have discussed whether all data were fully anonymized before you accessed them and/or whether the IRB or ethics committee waived the requirement for informed consent. If patients provided informed written consent to have data from their medical records used in research, please include this information.

� We apologize for not including these all data in the original document, and really appreciate your patience. It is now well explained in the methodology part, under the subtitle 2.8.

4.) Please amend your list of authors on the manuscript to ensure that each author is linked to an affiliation. Authors’ affiliations should reflect the institution where the work was done (if authors moved subsequently, you can also list the new affiliation stating “current affiliation:….” as necessary).

� Thank you for the comments, and corrected

5.) Please amend either the title on the online submission form (via Edit Submission) or the title in the manuscript so that they are identical.

� Done

6.) Please include captions for your Supporting Information files at the end of your manuscript, and update any in-text citations to match accordingly.

� Done

7.) Please include your tables as part of your main manuscript and remove the individual files. Please note that supplementary tables should be uploaded as separate "supporting information" files.

� We again apologizes for this, and now amended.

� We generally appreciate your cherished comments, and now feel the manuscript is appropriate for publication, as we tried our best in addressing all your productive comments point by point.

Reviewer #1: I read with great interest the paper. I find it well wrote on important topic. Only some suggestion 1. Introduction: diabetes is a risk factor for onset infectious diseases (es tuberculosis) and to worst outcome. Please add information about this relationship and how they influence in worst each other (see and cite doi: 10.4314/ahs.v17i3.20. PMID: 29085405; PMCID: PMC5656213; doi: 10.1186/s13104-018-3209-9. PMID: 29402317; PMCID: PMC5800087T doi: 10.1111/tmi.12704. Epub 2016 May 18. PMID: 27102229.).

Response; we are grateful to respond to your constructive comments, and we viewed the aforementioned papers, included some important points as deemed relevant.

For instances; Even though data regarding the prevalence of Diabetes Mellitus in active Tuberculosis is not sufficient in our country, literatures in other countries show the significant burden of Diabetes mellitus among active Tuberculosis with negative health outcomes. The problem is more worrisome in the developing countries where Tuberculosis is endemic, and the expected prevalence of Diabetes Mellitus is increasing alarmingly. [4,5]

2. Methods and result well wrote 3. Discussion add how is not only important diagnosis but care diabetes especially in low setting (see and cite. Diabetes in active tuberculosis in low-income countries: to test or to take care? Lancet Glob Health. 2019 Jun;7(6):e707. doi: 10.1016/S2214-109X(19)30173-1. PMID: 31097272)

o We appreciate for your review, on discussion part, yes we included the importance of cost effective strategies in curbing the burden of DM, especially in low income countries. We however did not discussed Diabetes in the active TB as it was not included in the result part. In fact it was mentioned in the introduction part as indicated above. We surely will consider it in our future research project.

Reviewer #2: The authors have made interesting observations in this study. Nevertheless, the study is demerited for several reasons as detailed in my comments below.

1. The study is not powered by a statistically calculated sample size as it has applied random sampling method. The observations of the study cannot be extrapolated to the general population due to it’s cross-sectional design.

� Response; the reviewer has made interesting points, and as you all one of the limitations of cross-sectional study design is that the study cannot comfortably extrapolate to the general population, but still can gives you clue on the burden of the problem. We recommended that our finding be justified by a better sample size and study design. In general, we strongly believe that our findings will add something to the diabetes mellitus care with all the limitations.

2. The study was conducted in 2017 and is communicated to a journal in 2020. This is a major concern as it limits the validity of the results for the recent times. The sample size is 191 subjects. To conduct this study in a hospital setting should not have been time consuming. I am concerned for reasons in delay in conducting and completing the study.

� Response; Sure, we are somehow late in communicating the journal. This is mainly because I, the correspondent author, was somehow busy of my study, Residency. We agreed that the findings in this paper will contributes something for the Diabetes care, particularly as there is no study done in the area on specific topic so far.

3. The salient findings of the study as mentioned in the abstract do not add any novel dimension for further research. I do not find any significance except for the fact that it is reported from a hospital in Ethiopia.

� This is an important point, and we still consider our study deemed important as it is the first in its kind in our study area. We, as a clinicians are witnessing the problems of adherence with Diabetes treatment in particular, and chronic diseases in general. We therefore want to know what is really behind these all mess specifically in our area. We are at least come to know that alcohol consumption and distance from the health facilities are among the obstacles, hence interested to work on these area for the betterment of our patients.

4. The manuscript is badly formatted. It appears that the authors did not proof check the manuscript and did not adhere to neat formatting norms on Word document. The manuscript appears un-appealing to the reviewers.

� We apologize for these inconveniences, and hope that you get the manuscript perfectly interesting now than before.

5. The authors have used erroneous English with too many grammatical errors and incomplete sentences. For eg “In the section on introduction the line “In Africa, up to 80 % of diabetic patients are underdiagnosed and will complicate” I am sure that this manuscript was not proof checked.

� We thank the reviewer for his effort, and we amended it, after we sought help from our colleges English Department staffs. It is now edited as; “In Africa, up to 80 % of diabetic patients are underdiagnosed, and appearing to the health care facilities with complications is not uncommon”.

6. The reference for Morisky Medication adherence questionnaire has not been cited.

� We appreciate for your detail evaluation of the paper, and now corrected and referred as reference number (17).

7. Though the tables 1 and 2 have been cited, they do not appear in the main PDF of the manuscript. The tables are badly formatted and do not appeal to the reviewers.

� Done

8. There are no foot notes below tables which indicate the lapse in correct presentation of results.

� We now put the amendment, and there is statement before each table elaborating about it.

9. Figures 1 and 2 are shoddy and needless.

� Omitted now based on your recommendation.

10. References are badly formatted and do not comply to the journal’s specifications.

� We understand and agree with this observation, and we thank the reviewer for pointing this out. It is now amended.

11. References 1 is unsuitable for a citation.

� Corrected

12. In short, this is a shoddy presentation of cross-sectional study with no robust validation. It would not worthwhile to make technical comments for a manuscript which does not comply to the basic requirements of a scientific manuscript. The authors need to seriously review the standard of writing manuscripts before communicating them to an international peer reviewed journal of significant impact factor. In view of the comments above, I deem it unsuitable for publication in Plos One in the present form.

� We really thank you for you’re the details and valuable comments on the manuscript, and we are optimistic that, now responses we replied above will suited you very well, and the manuscript is appropriate for publication.

Reviewer #3: The present manuscript encompasses a diabetes mellitus disease and non adherence . There are many articles on this subject in the literature. The present work needs a thorough revision in material and methods, results and discussion. Diabetes Mellitus Type 2 disease is extremely common amongst adults and the non adherence. Was this a case control study? the inclusion/exclusion criteria need more details. The status of Diabetes disease need to be determined by laboratory exams. These information can be shown in a descriptive table. It is also not clear if the number of subjects included in the study is supported by sample size calculations, as both diabetes and non adherence are common in the general population. Can this subject size support your conclusions? In summary, the study design needs to be revisited to improve its results and its relevance.

o Response; we thank the reviewer for his kind comments and useful insights. The methodology, results and discussion have been revised thoroughly. We included some important points which were not present in the original manuscript from the mother document.

o Regarding the study design, it was institutional based cross-sectional study, not a case control. The inclusion and exclusion criteria have been included in the methodology part.

o We understand your concern, and the study units were people with already diagnosed T2DM who have been on the treatment for more than three months.

o The detail of study design and sample size calculation was included under the methodology part, we would have included it in the sample size calculation. For further information, it has been described as follows;

o Sample size determination: The sample size was calculated using single population proportion formula as follows

n=Z12P(1−P)w2 n=(1.95)20.5(1−0.5)(0.05)2

n=3.84 x 0.5 x 0.50.025 n= 384

Where:

n=desired sample size for population >10,000

Z=standard normal duration usually set as 1.96 (which corresponds to 95% confidence level)

P=we use positive prevalence estimated. To maximize sample size. Negative prevalence =1-0.5=0.5

W=degree of accuracy desired (marginal error is 0.05)

As there is no previous study on topic under study in the study area, to estimate prevalence a figure of 0.5 used to get the possible minimum large sample size.

Since the total population is<10,000 that is 318; we use the Correction formula to determine final sample size.

��=n1+nN = ��=3841+384318 = 175

N=final sample size when a population is <10,000

n=initial sample size when the population is >10,000

nf=estimated study population

Then 10% contingency was added on 175

175×10%=17.5 = nf + contingency = 191

� We generally appreciate your valuable comments, and now feel the manuscript is appropriate for publication, as we tried our best in addressing all your constructive comments point by point.

Attachment

Submitted filename: Response letter to Reviewers.pdf

Decision Letter 1

Claudia Marotta

17 Feb 2021

The magnitude of non-adherence and contributing factors among adult outpatient with Diabetes mellitus in Dilla University Referral Hospital, Gedio, Ethiopia

PONE-D-20-36834R1

Dear Dr. Worku,

We’re pleased to inform you that your manuscript has been judged scientifically suitable for publication and will be formally accepted for publication once it meets all outstanding technical requirements.

Within one week, you’ll receive an e-mail detailing the required amendments. When these have been addressed, you’ll receive a formal acceptance letter and your manuscript will be scheduled for publication.

An invoice for payment will follow shortly after the formal acceptance. To ensure an efficient process, please log into Editorial Manager at http://www.editorialmanager.com/pone/, click the 'Update My Information' link at the top of the page, and double check that your user information is up-to-date. If you have any billing related questions, please contact our Author Billing department directly at authorbilling@plos.org.

If your institution or institutions have a press office, please notify them about your upcoming paper to help maximize its impact. If they’ll be preparing press materials, please inform our press team as soon as possible -- no later than 48 hours after receiving the formal acceptance. Your manuscript will remain under strict press embargo until 2 pm Eastern Time on the date of publication. For more information, please contact onepress@plos.org.

Kind regards,

Claudia Marotta

Academic Editor

PLOS ONE

Additional Editor Comments (optional):

dear Authors congratulations

Reviewers' comments:

Reviewer's Responses to Questions

Comments to the Author

1. If the authors have adequately addressed your comments raised in a previous round of review and you feel that this manuscript is now acceptable for publication, you may indicate that here to bypass the “Comments to the Author” section, enter your conflict of interest statement in the “Confidential to Editor” section, and submit your "Accept" recommendation.

Reviewer #1: All comments have been addressed

Reviewer #3: All comments have been addressed

**********

2. Is the manuscript technically sound, and do the data support the conclusions?

The manuscript must describe a technically sound piece of scientific research with data that supports the conclusions. Experiments must have been conducted rigorously, with appropriate controls, replication, and sample sizes. The conclusions must be drawn appropriately based on the data presented.

Reviewer #1: Yes

Reviewer #3: Yes

**********

3. Has the statistical analysis been performed appropriately and rigorously?

Reviewer #1: Yes

Reviewer #3: Yes

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4. Have the authors made all data underlying the findings in their manuscript fully available?

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Reviewer #1: Yes

Reviewer #3: Yes

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Reviewer #1: Yes

Reviewer #3: Yes

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6. Review Comments to the Author

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Reviewer #1: Authors worte an interesting paper. The role of non comunicable diseases in low setting is crucial also in global halth approuch wiev

I suggest to accept this new version of paper

Reviewer #3: (No Response)

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Reviewer #1: Yes: Francesco Di Gennaro

Reviewer #3: No

Acceptance letter

Claudia Marotta

22 Feb 2021

PONE-D-20-36834R1

The magnitude of non-adherence and contributing factors among adult outpatient with Diabetes mellitus in Dilla University Referral Hospital, Gedio, Ethiopia

Dear Dr. Bededa:

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Kind regards,

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on behalf of

Dr. Claudia Marotta

Academic Editor

PLOS ONE

Associated Data

    This section collects any data citations, data availability statements, or supplementary materials included in this article.

    Supplementary Materials

    S1 Fig. Showing the magnitude of adherence and non-adherence among the participants among T2DM patients who attend the medical referral clinics for treatment and follow up at DURH, 2017.

    (PDF)

    S1 File

    (PDF)

    Attachment

    Submitted filename: Review comments.docx

    Attachment

    Submitted filename: Response letter to Reviewers.pdf

    Data Availability Statement

    All relevant data are within the manuscript and its Supporting information files.


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