Medication-related burden among patients with diabetes mellitus and its relation to diabetic control parameters: an observational study

Ayman Jamal Noori; Dheyaa Jabbar Kadhim; Muqdad Abdulhasan Al-Hilal

doi:10.12688/f1000research.124941.1

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Research Article

Medication-related burden among patients with diabetes mellitus and its relation to diabetic control parameters: an observational study

[version 1; peer review: 1 approved with reservations]

Ayman Jamal Noori ¹, Dheyaa Jabbar Kadhim¹, Muqdad Abdulhasan Al-Hilal²

PUBLISHED 28 Sep 2022

Author details Author details

¹ Department of Clinical Pharmacy, College of Pharmacy, University of Baghdad, Baghdad, 10011, Iraq
² Specialized Center for Endocrinology and Diabetes, Alrusafa Health Directorate, Baghdad, 10011, Iraq

Ayman Jamal Noori
Roles: Conceptualization, Data Curation, Formal Analysis, Investigation, Methodology, Validation, Visualization, Writing – Original Draft Preparation, Writing – Review & Editing

Dheyaa Jabbar Kadhim
Roles: Conceptualization, Methodology, Supervision, Validation, Visualization, Writing – Review & Editing

Muqdad Abdulhasan Al-Hilal
Roles: Conceptualization, Methodology, Supervision, Validation, Visualization, Writing – Review & Editing

OPEN PEER REVIEW

REVIEWER STATUS

This article is included in the Sociology of Health gateway.

Abstract

Background: Diabetes mellitus (DM) refers to a group of metabolic abnormalities that are linked with significant morbidity, death, and health-care costs. Management options for patients with chronic illnesses such as diabetes are growing more complicated, which may result in a therapeutic burden for patients. The purpose of this research was to quantify the forms of concerns diabetic individuals have with medication that influence overall burden, as well as to examine the sociodemographic and clinical factors linked with negative medication use experiences and increased levels of burden.
Methods: The present research was a cross-sectional study of diagnosed diabetes patients who attended the Specialized Center for Endocrinology and Diabetes between 1^st of December 2021 and 30^th April 2022 in Baghdad, Iraq. The Living with Medicines Questionnaire (LMQ) was used to assess medication-related burden (MRB).
Results: The study recruited 193 patients with diabetes mellitus. The participants were adults with an average age of 50±15 years. More than half (52.8%) of the participating patients were women, and more than half (51.3%) also had one or more other chronic diseases. Additionally, 23.3% of patients had polypharmacy (≥ 5 medications). More than one-third had diabetes complications: neuropathy (45.6%) or retinopathy (38.9%). The mean LMQ score was (122.8±15.5). The research revealed that most of the DM patients experienced a moderate degree of medication burden (72.5%), followed by high burden (14.5%), minimum burden (12.4%), and no burden at all (0.5%) with no patient experiencing extremely high burden (0.0 %). Patients with uncontrolled blood glucose (high HbA1c), neuropathy, or retinopathy had a significantly higher medication burden.
Conclusions: The MRB among diabetic patients is at a very high level. This information may be helpful to health care professionals and policymakers seeking to understand MRB for patients with diabetes. Future studies should focus on developing interventions that help reduce such burdens.

Keywords

Diabetes mellitus, medication-related Burden, Living with Medicines Questionnaire, diabetic control parameters, Iraq

Corresponding author: Ayman Jamal Noori

Competing interests: No competing interests were disclosed.

Grant information: The author(s) declared that no grants were involved in supporting this work.

Copyright: © 2022 Jamal Noori A et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

How to cite: Jamal Noori A, Jabbar Kadhim D and Abdulhasan Al-Hilal M. Medication-related burden among patients with diabetes mellitus and its relation to diabetic control parameters: an observational study [version 1; peer review: 1 approved with reservations]. F1000Research 2022, 11:1112 (https://doi.org/10.12688/f1000research.124941.1) First published: 28 Sep 2022, 11:1112 (https://doi.org/10.12688/f1000research.124941.1) Latest published: 28 Sep 2022, 11:1112 (https://doi.org/10.12688/f1000research.124941.1)

Introduction

Diabetes is a series of metabolic abnormalities characterized by hyperglycemia which are caused by abnormalities in insulin activity, production, or even both. Type 1 and type 2 diabetes are the most common types of diabetes.¹ Type 2 diabetes is a chronic disease defined mostly by insulin resistance and high blood glucose levels, which may lead to increased morbidity and mortality.² Type 1 diabetes is characterized by autoimmune destruction of the pancreas' beta cells, leading to absolute insulin deficiency.³ Diabetes constitutes a severe public health care issue. According to the international diabetic federation, in 2021 the total global number of adult diabetic patients was 537 million, which represents 9.8% of the total population; 73 million live in the Middle East and North Africa (MENA), which include the highest regional prevalence of 16.2%.⁴^,⁵ In Iraq, studies suggested the prevalence of diabetes (13.9%). However, some Iraqi cities have a high diabetes mellitus (DM) prevalence of as much as one in five adults.⁶^,⁷

Many patients find it burdensome to take many medications for long-term diseases. This burden is complex and influenced by various aspects, such as medicine formulation, regimen, adverse outcomes, socioeconomic burden, and healthcare influences.⁸^–¹¹ Medicine has been demonstrated to make patients' everyday life more difficult, including medication administration, controlling, and traveling.⁸^,¹⁰ Medication-related burden (MRB) affects patients' health and well-being, as well as their views and behaviors regarding treatments.⁸ Diabetes is a non-communicable chronic disease that needs lifelong treatment, mostly with more than one medication to achieve the target blood glucose. The prevalence of many comorbidities and diabetic complications increase the number and burden of medication use.¹² Extra medication and much more complicated prescription programs have been associated with poorer patient outcomes, notably higher patient non-adherence.¹³^,¹⁴ Increased medication complexity or burden has also been associated with higher HbA1c, healthcare costs, and death rates among elderly individuals.¹⁵^–¹⁸

The purpose of this research was to quantify the sorts of concerns diabetic people have with medication that relate to total burden, as well as to examine the socio-demographic and clinical factors related with unfavourable medication use situations and high levels of burden.

Methods

Ethical approval

On March 23, 2021, the scientific and ethical committee of Baghdad University's College of Pharmacy reviewed and approved the research proposal that explains the aims of the present study as well as the anticipated procedures for data collection (ethics board approval code: 2615). Additionally, on November 11th, 2021, clearance was acquired from the Iraqi Ministry of Health (ethical board approval code: 110483). Before giving the questionnaire, the investigator described the goal of the research to each participant and got written consent to participate in the study. The participants were not offered any incentives.

Study design

This research was a descriptive cross-sectional study carried out on individuals who had been diagnosed with diabetes.

Setting

This study was carried out at a single location, and participants were recruited from patients who were seen at the Specialized Center for Endocrinology and Diabetes at the Al-Rusafa Health Directorate in Baghdad, Iraq, during the period from the first of December 2021 to the end of April 2022.

Sample size

The statistical tool G*Power (RRID:SCR 013726) edition 3.1.9.7 was utilized to determine the sample size. To a 95% confidence level, the following have been the calculated results: Df = 194, noncentrally parameter = 3.3087, critical t = 1.6527 The sample size required to be in the range of 196 individuals (f).

Eligibility criteria

The inclusion criteria of the study were diabetic patients aged 18 years and above of either sex that were diagnosed with DM at least one year before this study and used at least one pharmacological treatment for DM and were able to communicate and willing to participate in the study.

Exclusion criteria

The study's exclusion criteria were patients with cognitive, hearing, or speech deficits that affect their understanding level, pregnancy or lactation, and patients who give incomplete information.

Bias

Sampling error may arise throughout sample selection. This is especially noticeable in retrospective cohort studies when exposure and result have already occurred. In this research, sampling error is less likely. In order to get the desired conclusion, the ideal research population is well-defined, accessible, highly reliable, and reasonable. To avoid bias, participants were recruited in such a way that persons with hearing, speech, or cognitive problems that restrict topic understanding were excluded. We also used standard words to prevent confusion.

Study questionnaire

The study questionnaire is divided into two parts. The first part contains questions about patients' demographical and clinical information, including gender, age, duration of illness, social status, education level, residence, diabetes type, other chronic diseases, monthly income, emergency attendance, and several chronic medications currently used. The second part is the Living with Medicines Questionnaire (LMQ). The Arabic version¹⁹ of LMQ version 3 was used to measure MRB experienced by the DM patients. The LMQ-3 consists of 41 items about which participants expressed their overall degree of agreement using a 5 Point Likert scale [ranging from (strongly agree) through to (strongly disagree)]. It contained eight domains: interactions and communication with health care providers (HCPs) regarding medications (five items), practical difficulties (seven items), medications cost burden (three items), side-effects burden of drugs (four items), belief about the efficacy of medicines (six items), concern about medicine use (seven items), interferences of medications with daily life (six items), and control of drug use (three items). The sum of domain scores yields a total scale score (LMQ-3 overall score) measuring the general degree of MRB, varying from 41 to 205, with higher values suggesting greater pharmaceutical loads.¹⁹^–²²

Questionnaire administration

The researcher gathered all of the data needed for this study. After briefly describing the goal of the research and obtaining an informed consent form, the patients completed the questionnaire, which took around 15-20 minutes.

Laboratory and clinical examination

Additionally, the researcher (after patients’ permission) ordered blood sample withdrawal for the analysis of glycosylated hemoglobin in all patients involved in this study. Also, the researcher requested examining the patients for diabetic neuropathy using United Kingdom Screening Test,²³ while eye examination was performed by dilated fundus examination by a specialist physician.

Statistical analyses

During the statistical analysis, version 25 of the IBM SPSS Statistics (RRID: SCR 016479) software for Microsoft Windows was used. All research items were analyzed using descriptive statistics (means, standard deviations, frequencies, and percentages). The association between biological parameters and MRB Score was determined using Pearson correlation. Using independent T-tests and one-way analysis of variance (ANOVA) testing, the effect of patients' demographic and clinical features on MRB was determined (total LMQ Score). Furthermore, an independent T-test was employed to assess the associations between medication burden (total LMQ score) and DM control/complications (neuropathy & retinopathy). A P-value below 0.05 was considered statistically meaningful.

Results

The study recruited 193 patients with diabetes mellitus.³³ The participants were adults with an average age of (50.15±13.6 years). More than half (52.8%) of the participating patients were women, and more than three-quarters were married with primary/secondary school education. In addition, the majority (95.3%) have lived in urban areas and had low income (65.8%) (Table 1).

Table 1. The sociodemographic characteristics of the patients.

	Subcategory		Frequency (N)	%
Gender	Male		91	47.2
Gender	Female		102	52.8
Education level	Illiterate		22	11.4
	Primary school		89	46.1
	Secondary school		59	30.6
	College degree		23	11.9
Social status	Single		25	13
	Married		154	79.8
	Divorced		2	1.0
	Widowed		12	6.2
Living place	Urban		184	95.3
Living place	Rural		9	4.7
Cigarette smokers	Yes		31	16.1
Cigarette smokers	No		162	83.9
Monthly income	Less than 0.5 million ID		127	65.8
	0.5-1 million ID		50	25.9
	More than 1 million ID		16	8.3
Alcohol drinker	Yes		2	1
Alcohol drinker	No		191	99.0
	Minimum	Maximum	Mean	Std. Dev
Age (years)	18	77	50.15	13.6

The mean disease duration was (9.32±7.33 years). More than three quarters (83.4%) of the participating patients had type 2 DM, and more than half (51.3%) also had one or more chronic diseases. Additionally, 23.3% of patients had polypharmacy (≥ 5 medications). Less than one-quarter (16.1%) were admitted to the emergency room during the last 12 months. More than one-third had diabetes complications: neuropathy (45.6%) or retinopathy (38.9%) (Table 2).

Table 2. The clinical characteristics of the patients.

Clinical characteristic	Subcategory		Frequency (N)	%
DM type	Type 1 DM		32	16.6
DM type	Type 2 DM		161	83.4
No. of other chronic diseases	0		94	48.7
	1		65	33.7
	2		31	16.1
	3		3	1.6
Emergency admission in the last 12 months	Yes		31	16.1
Emergency admission in the last 12 months	No		162	83.9
No. of emergency admission in the last 12 months	1		8	4.1
	2		15	7.8
	3		3	1.6
	˃3		5	2.5
No. of chronic medications	1		18	9.3
	2		58	30.1
	3		42	21.8
	4		30	15.5
	5		20	10.4
	6		13	6.7
	≥7		12	6.2
Neuropathy	Without Neuropathy		104	53.9
	With Neuropathy		88	45.6
	Examination not accomplished		1	0.5
Retinopathy	Without retinopathy		113	58.5
	With retinopathy		75	38.9
	Examination not accomplished		5	2.6
DM duration (years)	Minimum	Maximum	Mean	Std. Dev
	1.00	38.00	9.32	7.33

The mean LMQ score was (122.8±15.5). The findings showed that most of the DM patients experienced a moderate degree of medication burden (72.5%), followed by a high burden (14.5%) and a minimum burden (12.4%), and no burden at all (0.5%), with no patient experiencing extremely high burden (0.0 %) as illustrated in Table 3.

Table 3. Perceived MRB using LMQ in patients with diabetes.

LMQ overall score (mean ± SD)		122.8±15.5
Degree of burden	The range of each category	Number of patients	%
No burden	(41-73)	1	0.52
Minimum burden	(74-106)	24	12.44
Moderate burden	(107-139)	140	72.54
High burden	(140-172)	28	14.50
Extremely high burden	(173-205)	-	-

Four LMQ domains had the lowest mean of burden scores (below the average): domain 1 (relationships with HCPs), domain 2 (practical difficulties in using medicines), domain 5 (effectiveness of prescribed medications), and domain 6 (concerns about drugs use). In other words, the patients had good relationships with HCPs, low practical difficulties in using medicine, reasonable belief in their effectiveness, and shared concerns about medicine use. On the other hand, four domains had the highest mean of burden scores: domain 3 (cost related burden), domain 4 (side effects of medicines), domain 7 (impact of using medications on daily life), and domain 8 (autonomy to vary regimen). In other words, the patients had difficulty with medicine costs, could not change their regimen, and their medicine impacted their daily life (Table 4).

Table 4. Descriptive statistics of LMQ domains.

LMQ themes	Minimum	Maximum	Mean	Std. deviation
Domain 1: Relationships with HCPs	6.00	20.00	12.52	2.26
Domain 2: Practical difficulties in using medicines	9.00	29.00	20.10	3.88
Domain 3: Cost-related burden	4.00	15.00	11.41	2.63
Domain 4: Side effects of medicines	4.00	19.00	12.68	3.25
Domain 5: Effectiveness of prescribed medications	8.00	22.00	14.29	3.08
Domain 6: Concerns about medicines use	14.00	35.00	22.45	3.77
Domain 7: Impact of using medicines on daily life	6.00	28.00	19.20	3.92
Domain 8: Autonomy to vary regimen	5.00	15.00	10.20	1.73

There were no significant differences in medication burden (total LMQ) according to patient demographic characteristics (Table 5).

Table 5. Influence of patients’ demographics on medication burden (total LMQ).

	Characteristics	N	Mean	Std. deviation	P-value
	Age
Total LMQ	<65 years	169	123.03	15.52	0.661
Total LMQ	≥65 years	24	121.54	15.79	0.661
	Gender
Total LMQ	Male	91	122.20	15.41	0.586
Total LMQ	Female	102	123.42	15.67	0.586
	Residence
Total LMQ	Urban	184	122.92	15.74	0.749
	Rural	9	121.22	10.52
	No	191	122.95	15.55
	DM type
Total LMQ	Type 1	32	125.47	15.41	0.296
Total LMQ	Type 2	161	122.32	15.54	0.296
	Social status
Total LMQ	Without spouse	39	123.95	15.39	0.62
Total LMQ	With spouse	154	122.56	15.59	0.62
	Income
Total LMQ	˂0.5 million ID	127	123.36	15.62	0.518
	0.5-1.0 million ID	50	122.88	13.35
	>1.0 million ID	16	118.63	20.78
	Education
Total LMQ	Illiterate	22	128.32	14.03	0.057
	primary school	89	123.47	14.44
	Secondary school	59	122.56	15.23
	University	23	115.91	19.67

Patients who were admitted to the emergency department (ED) last year had a significantly (P-value <0.05) higher medication burden (total LMQ) compared to not admitted patients (Table 6).

Table 6. Influence of patients’ clinical characteristics on medication burden (total LMQ score).

	Clinical characteristics	N	Mean	Std. deviation	P-value
	DM type
Total LMQ	Type 1	32	125.47	15.41	0.296
Total LMQ	Type 2	161	122.32	15.54	0.296
	ED admission last year
Total LMQ	Yes	31	130.65	11.83	0.002*
Total LMQ	No	162	121.35	15.72	0.002*
	Chronic disease
Total LMQ	No	94	122.10	16.49	0.515
Total LMQ	Yes	99	123.56	14.59	0.515
	No. of chronic medications
Total LMQ	≤5	168	122.48	15.72	0.394
Total LMQ	>5	25	125.32	14.17	0.394
	Disease duration
Total LMQ	≤5 years	73	120.60	14.35	0.118
Total LMQ	>5 years	120	124.21	16.10	0.118

* Significant (P-value <0.05) according to independent T-test; DM: diabetes mellitus; ED: emergency department; LMQ: Living with Medicines Questionnaire.

There were significant (P-value <0.05) differences in medication burden in terms of total LMQ scores according to diabetes control (HbAlc) and complications (neuropathy and retinopathy). In other words, patients with uncontrolled blood glucose (high HbA1c), neuropathy, or retinopathy had a significantly (P-value <0.05) higher medication burden (total LMQ) (Table 7).

Table 7. The relationships between medication burden (total LMQ) and DM control/complications (neuropathy & retinopathy).

Medication burden parameter	HbA1c	N	Mean	Std. deviation	P-value
Total LMQ	≤7	35	115.06	15.09	0.001*
Total LMQ	˃7	157	124.65	15.14	0.001*
	Neuropathy
Total LMQ	No	104	119.60	14.33	0.001*
	Yes	88	126.84	16.05	0.001*
	Retinopathy
Total LMQ	No	113	120.55	15.21	0.009*
	Yes	75	126.49	15.26	0.009*

* Significant (P-value <0.5) according to independent T-test. DM: diabetes mellitus; HbA1c: haemoglobin A1c; LMQ: Living with Medicines Questionnaire.

Discussion

Diabetes is a chronic condition requiring long-term medical treatment. Whenever lifestyle adjustments alone fail to achieve or maintain the desired glycemic control, the majority of patients are routinely recommended prescription medicine.¹² The vast majority of published studies have understood the biological viewpoint of MRB as the quantity of pills or treatments frequently taken by specific patients to treat their conditions, ignoring the patient’s views.⁹^,²⁴ To our knowledge, no published research has quantified MRB amongst diabetic patients in Iraq. Consequently, the purpose of this research was to assess the problems diabetic patients encounter with drugs that contribute to the overall MRB and the variables that affect them.

The current study indicated that nearly all the participants (99%) suffered from varying degrees of MRB. A study in Qatar found that 90% of DM patients were suffering from MRB.¹⁹ Utilization of prescription medication to manage glucose levels and manage concomitant illnesses is an important aspect of diabetes therapy and might even greatly contribute to the MRB for this disease. The most frequent degree of MRB in the current study was moderate burden (72.5%); however, inconsistent with the results of the present study, most DM participants in Qatar were of minimum burden (66.8%). The high level of services administered to DM patients in Qatar at low cost and in one clinical setting¹⁹ may explain such findings.

Four domains had the highest mean of burden scores: cost-related burden, side effects of medicine, the impact of using medication on daily life, and autonomy to vary regimen. Traditionally the focus of guidelines for clinical practice on specific diseases, the growing coexistence of various chronic conditions, and the lack of systematic strategies for addressing issues related with the implications of therapies supposed that patients with long-term illnesses such as DM had to deal with complex medication-related instructions and tasks for the remainder of their lives.²⁵ Dealing with the unpleasant effects of medication and needing to adjust daily activities to meet the requirements of therapeutic interventions imposes an additional stress on individuals.²⁶^–²⁸ On the other hand, the patients had good relationships with HCPs, low practical difficulties in using medicine, reasonable belief in their effectiveness, and shared concerns about medicine use. The preponderance of patients with T2DM in Iraq (76.3%) according to a prior research were adamant about the requirement of anti-diabetic therapy for ensuring constant glycemic control (scores of specific-necessity were more significant than the score of specific-concern).²⁹

There were no significant differences in medication burden (total LMQ) according to patient demographic characteristics. However, a study in Qatar found that unmarried, female gendered DM patients demonstrated significantly higher scores of medication burden.¹⁹ Patients admitted to ED last year had substantially higher MRB (total LMQ) compared to not admitted patients. Previous studies showed that high MRB leads to decreased medication adherence,¹⁹^,²² and the non-adherence to medication increases emergency room visits and hospitalization.³⁰ Patients with uncontrolled blood glucose (high HbA1c), neuropathy, or retinopathy had significantly higher medication burdens. Diabetes-related microvascular and macrovascular complications in many patients with type 2 diabetes result in polypharmacotherapy and a high pill burden.³¹^,³²

The limitations of the present research demand examination. First, an MRB measurement was patient-reported and hence subjective. The research sample was limited to a single site; therefore, the results may not be representative of the population of individuals with DM in Iraq. Thirdly, due to the cross-sectional design of the research, we were unable to examine how these patient experiences evolved over time.

Conclusions

The medicine burden for diabetic people is at a very high level. This knowledge may assist pharmacists, doctors, nurses, and other clinicians, as well as policymakers, in comprehending MRB for people with diabetes. Accordingly, future studies should continue to measure MRB while moving the science toward developing interventions aimed at reducing such burdens.

Data availability

Underlying data

Zenodo: Demographic details, as well as questionnaire responses, https://doi.org/10.5281/zenodo.6968395.³³

This project contains the following underlying data:

- Article’s data.xlsx (Demographic details, as well as questionnaire responses)

Data are available under the terms of the Creative Commons Attribution 4.0 International license (CC-BY 4.0).

Acknowledgments

The authors thank the participants and the Specialized Center for Endocrinology and Diabetes, Alrusafa Health Directorate, Baghdad/Iraq team for their continuous support during data collection and patient interviews.

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30. Polonsky WH, Henry RR: Poor medication adherence in type 2 diabetes: recognizing the scope of the problem and its key contributors. Patient Prefer. Adherence. 2016; 10: 1299–1307. PubMed Abstract | Publisher Full Text
31. Morrish NJ, Wang SL, Stevens LK, et al.: Mortality and causes of death in the WHO Multinational Study of Vascular Disease in Diabetes. Diabetologia. 2001; 44(2): S14–S21. PubMed Abstract | Publisher Full Text
32. Stamler J, Vaccaro O, Neaton JD, et al.: Multiple Risk Factor Intervention Trial Research G. Diabetes, other risk factors, and 12-yr cardiovascular mortality for men screened in the Multiple Risk Factor Intervention Trial. Diabetes Care. 1993; 16(2): 434–444. PubMed Abstract | Publisher Full Text
33. Noori AJ: Demographic details, as well as questionnaire responses. [Dataset]. Zenodo.2022. Publisher Full Text

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Author details Author details

¹ Department of Clinical Pharmacy, College of Pharmacy, University of Baghdad, Baghdad, 10011, Iraq
² Specialized Center for Endocrinology and Diabetes, Alrusafa Health Directorate, Baghdad, 10011, Iraq

Ayman Jamal Noori
Roles: Conceptualization, Data Curation, Formal Analysis, Investigation, Methodology, Validation, Visualization, Writing – Original Draft Preparation, Writing – Review & Editing

Dheyaa Jabbar Kadhim
Roles: Conceptualization, Methodology, Supervision, Validation, Visualization, Writing – Review & Editing

Muqdad Abdulhasan Al-Hilal
Roles: Conceptualization, Methodology, Supervision, Validation, Visualization, Writing – Review & Editing

Competing interests

No competing interests were disclosed.

Grant information

The author(s) declared that no grants were involved in supporting this work.

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Published: 28 Sep 2022, 11:1112

https://doi.org/10.12688/f1000research.124941.1

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Jamal Noori A, Jabbar Kadhim D and Abdulhasan Al-Hilal M. Medication-related burden among patients with diabetes mellitus and its relation to diabetic control parameters: an observational study [version 1; peer review: 1 approved with reservations]. F1000Research 2022, 11:1112 (https://doi.org/10.12688/f1000research.124941.1)

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Open Peer Review

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VERSION 1

PUBLISHED 28 Sep 2022

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Reviewer Report 16 Dec 2022

Ahmed Awaisu, Department of Clinical Pharmacy and Practice, College of Pharmacy, QU Health, Qatar University, Doha, Qatar

Approved with Reservations

https://doi.org/10.5256/f1000research.137189.r151759

This paper presents an interesting study about patient-reported medication burden in patients with diabetes in Iraq and its relationship with diabetes control. However, major revisions are needed for the paper to be indexed. I suggest some recommendations for improvement.
... Continue reading

This paper presents an interesting study about patient-reported medication burden in patients with diabetes in Iraq and its relationship with diabetes control. However, major revisions are needed for the paper to be indexed. I suggest some recommendations for improvement.

General

The manuscript is fairly well-written. However, it requires significant editing, syntax improvement and attention to detail in several places. Definitely, this paper should undergo professional language editing by experts in the area in order to be considered for indexing.
Throughout the manuscript, poor and inappropriate scientific terminologies were used. For example, "diabetic patients" instead of patients with diabetes, "diabetic people", "complicated prescription program", "pharmaceutical loads " etc.
This is a single-center study with a very small sample (193 patients) and one cannot draw generalizations from the findings; therefore, I doubt the usefulness of this study.
The Introduction needs significant improvement to identify gaps in the literature and the rationale for the conduct of the study.
The Methods section requires improvement as will be explained later.
The data require more robust statistical analysis, specifically multivariate regression analysis.
Finally, the results, particularly the tables, need better presentation.

Abstract

The Abstract is fairly well-written, but syntax and readability can be better in places.
The study objective is not clear and not SMART (Specific, Measurable, Achievable, Reliable, Time-framed). Please revise in the Abstract and the main manuscript.

Introduction

The Introduction and other parts of the paper contain several grammatical errors in places. Several sentences need syntax and readability improvement. Therefore, the paper should undergo language editing before it can be considered for indexing.
An Introduction should reflect “what is known”, “the gap in the literature”, “the research problem and rationale” and “the study objectives”. The Introduction has provided some insight into what is known in the literature. However, the gaps are not clearly presented and the rationale for the conduct of the study is not presented.
The following sentence is poorly written: “Medicine has been demonstrated to make patients' everyday life more difficult, including medication administration, controlling, and traveling.^8,10”
Again, I would like to stress that the study objective is not SMART and not well-written.

Methods

The Methods contain most of the elements required; however, most sub-sections require improvement.
Setting: The study setting is not adequately described. What is this center for? How many patients attend the center monthly and annually? Who or which population in Iraq does the center serve? What about the services, facilities, and specialties available? Please also write the dates of patients' recruitment using proper conventions of writing dates.
Sample size: How were the parameters used for sample size estimation determined? I am not very convinced as these were unconventional parameters for a cross-sectional study.
Sampling technique: The sampling technique has not been described, yet the investigators concluded that there was no bias in their study.
Bias: As a reader, I do not agree with the content of this section. For a study that is single-centered and with no description of sampling technique, how could you assume that its findings are free of bias?
Study questionnaire: Describe the psychometrics of the original LMQ and the Arabic-translated version. What are “pharmaceutical loads”?
Statistical analysis: I am very certain that the data analysis is suboptimal. The investigators should consult with an experienced biostatistician to conduct more robust analysis. For example, multivariate logistic regression analysis may be needed in order to relate the medication burden and other factors (demographic and clinical) with glycemic control. In this case, univariate regression may be warranted before the multivariate regression analysis.

Results

Authors try to explain the finding, which is not needed.
All tables need to be revised and improved to meet the standard of tables in published articles.
Table 1: Merge the column of frequency with that of %. "Illiterate"? Do you mean 'No formal education'?
Table 2: Merge the column of frequency with that of %. I am very surprised that no patients with “nephropathy (kidney damage)” among the whole study population. It is surprising to see that in a population of patients with diabetes, there was no patient with a complication of nephropathy or CKD, which is highly prevalent.
Table 3: It is really confusing how the ranges of burden were determined. Are these based on a validated method or reference?
Table 5: Merge the column of mean with that of SD (it should be mean±SD). Remove the column with “Total LMQ” as it is unnecessary.
Table 6: Merge the column of mean with that of SD (it should be mean±SD). Remove the column with “Total LMQ” as it is unnecessary.
Table 7: Same as above

Discussions

The Discussion should be improved to focus on the major findings and to cite relevant literature. Several important previous studies are not cited. The authors should be able to do a more thorough literature search. There are several studies from USA, Malaysia, and Europe.

Conclusion

Can be better written to reflect the study objectives and findings.

Decision: MAJOR REVISION

Is the work clearly and accurately presented and does it cite the current literature?

Partly
Is the study design appropriate and is the work technically sound?

Yes
Are sufficient details of methods and analysis provided to allow replication by others?

Partly
If applicable, is the statistical analysis and its interpretation appropriate?

Partly
Are all the source data underlying the results available to ensure full reproducibility?

Partly
Are the conclusions drawn adequately supported by the results?

Yes

Competing Interests: No competing interests were disclosed.

Reviewer Expertise: Medication use optimization and outcome research

I confirm that I have read this submission and believe that I have an appropriate level of expertise to confirm that it is of an acceptable scientific standard, however I have significant reservations, as outlined above.

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Ahmed Awaisu, Qatar University, Doha, Qatar

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Reviewer Report

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16 Dec 2022 | for Version 1

Ahmed Awaisu, Department of Clinical Pharmacy and Practice, College of Pharmacy, QU Health, Qatar University, Doha, Qatar

16 Views Cite this report Responses(0)

Approved With Reservations

This paper presents an interesting study about patient-reported medication burden in patients with diabetes in Iraq and its relationship with diabetes control. However, major revisions are needed for the paper to be indexed. I suggest some recommendations for improvement.

General

The manuscript is fairly well-written. However, it requires significant editing, syntax improvement and attention to detail in several places. Definitely, this paper should undergo professional language editing by experts in the area in order to be considered for indexing.
Throughout the manuscript, poor and inappropriate scientific terminologies were used. For example, "diabetic patients" instead of patients with diabetes, "diabetic people", "complicated prescription program", "pharmaceutical loads " etc.
This is a single-center study with a very small sample (193 patients) and one cannot draw generalizations from the findings; therefore, I doubt the usefulness of this study.
The Introduction needs significant improvement to identify gaps in the literature and the rationale for the conduct of the study.
The Methods section requires improvement as will be explained later.
The data require more robust statistical analysis, specifically multivariate regression analysis.
Finally, the results, particularly the tables, need better presentation.

Abstract

The Abstract is fairly well-written, but syntax and readability can be better in places.
The study objective is not clear and not SMART (Specific, Measurable, Achievable, Reliable, Time-framed). Please revise in the Abstract and the main manuscript.

Introduction

The Introduction and other parts of the paper contain several grammatical errors in places. Several sentences need syntax and readability improvement. Therefore, the paper should undergo language editing before it can be considered for indexing.
An Introduction should reflect “what is known”, “the gap in the literature”, “the research problem and rationale” and “the study objectives”. The Introduction has provided some insight into what is known in the literature. However, the gaps are not clearly presented and the rationale for the conduct of the study is not presented.
The following sentence is poorly written: “Medicine has been demonstrated to make patients' everyday life more difficult, including medication administration, controlling, and traveling.^8,10”
Again, I would like to stress that the study objective is not SMART and not well-written.

Methods

The Methods contain most of the elements required; however, most sub-sections require improvement.
Setting: The study setting is not adequately described. What is this center for? How many patients attend the center monthly and annually? Who or which population in Iraq does the center serve? What about the services, facilities, and specialties available? Please also write the dates of patients' recruitment using proper conventions of writing dates.
Sample size: How were the parameters used for sample size estimation determined? I am not very convinced as these were unconventional parameters for a cross-sectional study.
Sampling technique: The sampling technique has not been described, yet the investigators concluded that there was no bias in their study.
Bias: As a reader, I do not agree with the content of this section. For a study that is single-centered and with no description of sampling technique, how could you assume that its findings are free of bias?
Study questionnaire: Describe the psychometrics of the original LMQ and the Arabic-translated version. What are “pharmaceutical loads”?
Statistical analysis: I am very certain that the data analysis is suboptimal. The investigators should consult with an experienced biostatistician to conduct more robust analysis. For example, multivariate logistic regression analysis may be needed in order to relate the medication burden and other factors (demographic and clinical) with glycemic control. In this case, univariate regression may be warranted before the multivariate regression analysis.

Results

Authors try to explain the finding, which is not needed.
All tables need to be revised and improved to meet the standard of tables in published articles.
Table 1: Merge the column of frequency with that of %. "Illiterate"? Do you mean 'No formal education'?
Table 2: Merge the column of frequency with that of %. I am very surprised that no patients with “nephropathy (kidney damage)” among the whole study population. It is surprising to see that in a population of patients with diabetes, there was no patient with a complication of nephropathy or CKD, which is highly prevalent.
Table 3: It is really confusing how the ranges of burden were determined. Are these based on a validated method or reference?
Table 5: Merge the column of mean with that of SD (it should be mean±SD). Remove the column with “Total LMQ” as it is unnecessary.
Table 6: Merge the column of mean with that of SD (it should be mean±SD). Remove the column with “Total LMQ” as it is unnecessary.
Table 7: Same as above

Discussions

The Discussion should be improved to focus on the major findings and to cite relevant literature. Several important previous studies are not cited. The authors should be able to do a more thorough literature search. There are several studies from USA, Malaysia, and Europe.

Conclusion

Can be better written to reflect the study objectives and findings.

Decision: MAJOR REVISION

Is the work clearly and accurately presented and does it cite the current literature?

Partly
Is the study design appropriate and is the work technically sound?

Yes
Are sufficient details of methods and analysis provided to allow replication by others?

Partly
If applicable, is the statistical analysis and its interpretation appropriate?

Partly
Are all the source data underlying the results available to ensure full reproducibility?

Partly
Are the conclusions drawn adequately supported by the results?

Yes

Competing Interests

No competing interests were disclosed.

Reviewer Expertise

Medication use optimization and outcome research

I confirm that I have read this submission and believe that I have an appropriate level of expertise to confirm that it is of an acceptable scientific standard, however I have significant reservations, as outlined above.

Respond to this report

Responses (0)

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[2] 2. Carrillo-Sepulveda MA, Maddie N, Johnson CM, et al.: Vascular hyperacetylation is associated with vascular smooth muscle dysfunction in a rat model of non-obese type 2 diabetes. Mol. Med. 2022; 28(1): 1–14.

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[16] 16. Rodbard HW, Green AJ, Fox KM, et al.: Impact of type 2 diabetes mellitus on prescription medication burden and out-of-pocket healthcare expenses. Diabetes Res. Clin. Pract. 2010; 87(3): 360–365. PubMed Abstract | Publisher Full Text

[17] 17. Wimmer BC, Bell JS, Fastbom J, et al.: Medication regimen complexity and polypharmacy as factors associated with all-cause mortality in older people: a population-based cohort study. Ann. Pharmacother. 2016; 50(2): 89–95.

[18] 18. Abdelaziz TS, Sadek KM: Effect of reducing medication regimen complexity on glycaemic control in patients with diabetes. Rom. J. Intern. Med. 2019; 57(1): 23–29. PubMed Abstract | Publisher Full Text

[19] 19. Zidan A, Awaisu A, El-Hajj MS, et al.: Medication-related burden among patients with chronic disease conditions: perspectives of patients attending non-communicable disease clinics in a primary healthcare setting in Qatar. Pharmacy. 2018; 6(3): 85. PubMed Abstract | Publisher Full Text

[20] 20. Katusiime B, Corlett SA, Krska J: Development and validation of a revised instrument to measure burden of long-term medicines use: the Living with Medicines Questionnaire version 3. Patient Relat. Outcome Meas. 2018; 9: 155–168. PubMed Abstract | Publisher Full Text

[21] 21. Zidan A, Awaisu A, Hasan S, et al.: The Living with Medicines Questionnaire: translation and cultural adaptation into the Arabic context. Value Health Reg. Issues. 2016; 10: 36–40. PubMed Abstract | Publisher Full Text

[22] 22. Awad A, Alhadab A, Albassam A: Medication-related burden and medication adherence among geriatric patients in Kuwait: a cross-sectional study. Front. Pharmacol. 2020; 11: 1296. PubMed Abstract | Publisher Full Text

[23] 23. Soheilykhah S, Rashidi M, Dehghan F, et al.: Prevalence of peripheral neuropathy in diabetic patients. Iranian Journal of Diabetes and Obesity. 2013; 5(3): 107–113.

[24] 24. Krska J, Corlett SA, Katusiime B: Complexity of medicine regimens and patient perception of medicine burden. Pharmacy. 2019; 7(1): 18. PubMed Abstract | Publisher Full Text

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[30] 30. Polonsky WH, Henry RR: Poor medication adherence in type 2 diabetes: recognizing the scope of the problem and its key contributors. Patient Prefer. Adherence. 2016; 10: 1299–1307. PubMed Abstract | Publisher Full Text

[31] 31. Morrish NJ, Wang SL, Stevens LK, et al.: Mortality and causes of death in the WHO Multinational Study of Vascular Disease in Diabetes. Diabetologia. 2001; 44(2): S14–S21. PubMed Abstract | Publisher Full Text

[32] 32. Stamler J, Vaccaro O, Neaton JD, et al.: Multiple Risk Factor Intervention Trial Research G. Diabetes, other risk factors, and 12-yr cardiovascular mortality for men screened in the Multiple Risk Factor Intervention Trial. Diabetes Care. 1993; 16(2): 434–444. PubMed Abstract | Publisher Full Text

[33] 33. Noori AJ: Demographic details, as well as questionnaire responses. [Dataset]. Zenodo.2022. Publisher Full Text

Medication-related burden among patients with diabetes mellitus and its relation to diabetic control parameters: an observational study

Abstract

Keywords

Introduction

Methods

Ethical approval

Study design

Setting

Sample size

Eligibility criteria

Exclusion criteria

Bias

Study questionnaire

Questionnaire administration

Laboratory and clinical examination

Statistical analyses

Results

Table 1. The sociodemographic characteristics of the patients.

Table 2. The clinical characteristics of the patients.

Table 3. Perceived MRB using LMQ in patients with diabetes.

Table 4. Descriptive statistics of LMQ domains.

Table 5. Influence of patients’ demographics on medication burden (total LMQ).

Table 6. Influence of patients’ clinical characteristics on medication burden (total LMQ score).

Table 7. The relationships between medication burden (total LMQ) and DM control/complications (neuropathy & retinopathy).

Discussion

Conclusions

Data availability

Underlying data

Acknowledgments

References

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