Assessment of medication-related burden among a sample of Iraqi patients with systemic lupus erythematosus and its relationship with disease activity: a cross-sectional study

Hawraa Kadhim Abbas; Dheyaa Jabbar Kadhim; Faiq Isho Gorial; Laith G. Shareef

doi:10.12688/f1000research.124698.1

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Research Article

Assessment of medication-related burden among a sample of Iraqi patients with systemic lupus erythematosus and its relationship with disease activity: a cross-sectional study

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

Hawraa Kadhim Abbas¹, Dheyaa Jabbar Kadhim¹, Faiq Isho Gorial², Laith G. Shareef ³

PUBLISHED 23 Aug 2022

Author details Author details

¹ Department of Clinical Pharmacy, College of Pharmacy, University of Baghdad, Baghdad, 10011, Iraq
² Rheumatology Unit, Department of Medicine, College of Medicine, University of Baghdad, Baghdad, 10011, Iraq
³ Department of Pharmacy, Al-Esraa University College, Baghdad, 10011, Iraq

Hawraa Kadhim Abbas
Roles: Conceptualization, Data Curation, Formal Analysis, Funding Acquisition, Investigation, Methodology, Project Administration, Writing – Original Draft Preparation

Dheyaa Jabbar Kadhim
Roles: Conceptualization, Methodology, Project Administration, Supervision, Validation, Visualization

Faiq Isho Gorial
Roles: Investigation, Methodology, Software, Supervision, Validation, Visualization, Writing – Review & Editing

Laith G. Shareef
Roles: Resources, Software, Validation, Visualization, Writing – Review & Editing

OPEN PEER REVIEW

REVIEWER STATUS

Abstract

Background: Systemic lupus erythematosus (SLE) is a chronic autoimmune disease with high morbidity and disability. The routines involved in taking medications, side effects, the nature of medicines, difficulties with the healthcare system, and disruptions to social activities all contribute to patients frequently experiencing medication-related burdens (MRB). The current study aimed to assess the perceived MRB among a sample of SLE patients from Iraq and to look for any possible relationship between MRB and disease activity.
Methods: The current study was cross-sectional on diagnosed SLE patients who arrived at Baghdad Teaching Hospital/Medical City/Rheumatology department from September 2021 to January 2022. MRB was measured using the Living with Medicines Questionnaire (LMQ).
Results: The study recruited 156 SLE patients. The patients were 35.8 ±11.7 years old on average. Great majority of them were women (96.8 %). The average LMQ score was 117.30± 18.37. The results showed that most patients (69.87%) experienced a moderate level of burden, followed by a low level (19.87%), high level (7.69%), and no burden at all (2.56%). No patients experienced an extremely high level of burden (0.0%). The mean burden scores for two LMQ domains—relationships with health care professionals (HCPs) and effectiveness of prescription medications—were the lowest (below average).
Conclusions: Many of the SLE patients in this study reported experiencing MRB. Healthcare professionals should implement strategies to reduce this burden, particularly for low-income patients.

Keywords

Systemic lupus erythematosus, medication-related burden, Living with Medicines Questionnaire, SELENA-SLEDAI, Iraq.

Corresponding author: Laith G. Shareef

Competing interests: No competing interests were disclosed.

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

Copyright: © 2022 Kadhim Abbas H 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: Kadhim Abbas H, Jabbar Kadhim D, Isho Gorial F and Shareef LG. Assessment of medication-related burden among a sample of Iraqi patients with systemic lupus erythematosus and its relationship with disease activity: a cross-sectional study [version 1; peer review: 1 approved with reservations]. F1000Research 2022, 11:970 (https://doi.org/10.12688/f1000research.124698.1) First published: 23 Aug 2022, 11:970 (https://doi.org/10.12688/f1000research.124698.1) Latest published: 01 Nov 2022, 11:970 (https://doi.org/10.12688/f1000research.124698.2)

Introduction

Systemic lupus erythematosus (SLE) is a chronic, heterogeneous autoimmune disease associated with complex and varied immunological dysregulation.¹ Regardless of age or race, women of childbearing age are 10 times more likely than men to be affected by SLE. Globally, SLE prevalence and incidence vary considerably with sex, age, ethnicity, and time.² In Iraq, the prevalence of SLE is about 1/1867 of the general population, and the first case of SLE was reported in 1971.³ Genetic factors, environmental factors, and hormonal factors are believed to contribute to the occurrence of SLE.⁴ Systemic lupus erythematosus is an autoimmune disease with a chronic-relapsing course in which periods of remission alternate with periods of activity of the disease.⁵ Multiple organ systems, including the musculoskeletal, mucocutaneous, cardiopulmonary, renal, and hematologic systems, are clinically involved in SLE.¹ The short-term goals of SLE treatment are to reduce or control disease activity, alleviate clinical symptoms, and achieve clinical remission. The long-term objectives are to achieve long-term sustained remission of the disease, lower mortality, enhance the quality of life, avoid and reduce recurrence, reduce adverse drug responses, prevent and control organ damage carried on by the disease, and prevent and control certain organ damage events.⁶ The US Food and Drug Administration currently approved corticosteroids, antimalarials like hydroxychloroquine, and belimumab for treating SLE. Nonsteroidal anti-inflammatory drugs (NSAIDs), immunosuppressive and immunomodulatory drugs and rituximab are further treatments for the management of SLE.⁷ The idea of “medication-related burden” (MRB) or “treatment burden” succinctly describes the entire workload that patients are subject to as a result of using healthcare, with several harmful effects on their lives.⁸ Because medications are the primary method of managing most disorders, MRB is a significant portion of the overall treatment burden and is commonly mentioned in qualitative studies.⁹ The treatment burden includes financial, temporal, physical, and psychosocial time demands on patients to adhere to the recommended treatment plan.¹⁰ Adherence to the prescribed regimen may be difficult for patients who experience high MRB. As a result, patients stop taking their medications as prescribed, which raises morbidity and mortality, the frequency of hospital admissions, and the expenditure on healthcare.⁹ Systemic lupus erythematosus is associated with high unmet needs and a considerable patient burden.¹¹ The current study aimed to measure MRB among a sample of Iraqi patients with SLE and to determine the possible association between MRB and disease activity.

Methods

Ethical approval

The scientific and ethical committee examined and gave its approval to the research proposal that was submitted to the College of Pharmacy, the University of Baghdad, which describes the goals of the current study as well as the expected methods for data collection (ethics board approval code: 2014 on 15^th February 2021). Additionally, approval was obtained from the Iraqi Ministry of Health (ethics board approval code: 6325) on 25^th February 2021. The investigator explained the purpose of the study to each participant and obtained verbal consent. Written informed consent was then gained before administering the questionnaire. No incentives were offered to the patients.

Study design

The current study was an observational, cross-sectional study on already diagnosed SLE patients.

Setting

This research was conducted in a single center and recruited patients who attended Baghdad Teaching Hospital/Medical City/Rheumatology Department from September 2021 to January 2022.

Sample size

G*Power (RRID:SCR_013726) version 3.1.9.7 software was used to figure out the number of participants. With a 95% confidence interval, 90% power, a two-tailed alpha of 0.05, and an effect size of 0.30, and the output parameters were as the following: noncentrally parameter δ= 3.6404323, critical t =1.9780988, Df= 132 the sample size had to be at least 134 patients (f).

Eligibility criteria

The inclusion criteria of the study were: (1) SLE patients who were eligible to participate in the study and were ≥ 18 years of age and either sex, (2) Had the disease for ≥ 6 months.

Exclusion criteria

The exclusion criteria of the study were: (1) Patients didn’t consent to participate, (2) Patients with hearing, speech, or cognitive deficits (physical or mental state) impairing understanding of the questions.

Bias

During sample selection, selection bias may occur. This is particularly apparent in retrospective cohort studies when exposure and outcome have already happened. As a matter of fact, in this study, sampling error is less probable. The ideal study population is well-defined, accessible, highly dependable, and reasonable in order to get the intended outcome. To remove prejudice, participants were chosen in such a manner that individuals with hearing, speech, or cognitive issues that limit subject understanding were not given included. We also utilized common terms to prevent misinterpretation.

The questionnaires

The Arabic version⁸ of the living with medicine questionnaire (LMQ) was used to assess MRB in SLE patients. The LMQ consisted of 41 items to which participants responded on a five-point Likert-type scale (from strongly disagree to agree strongly). Furthermore, a free text (open-ended) question permitted the participant to add any additional topics not addressed in the questionnaire. Relationships with health professionals, Practicalities, Information, Efficacy, Side effects, Attitudes, Impact, and Control were the 8 domains covered by the questionnaire. The total LMQ score is the sum of all 41 questionnaire questions and ranges from 41 to 205, with higher scores suggesting more MRB.⁸ In addition, SLE disease activity was evaluated using the Systemic Lupus Erythematosus Disease Activity Index score with the Safety of Estrogens in Lupus Erythematosus National Assessment (SELENA-SLEDAI).¹²

Administration of questionnaires

When the patients presented at the Rheumatology Department, they were asked whether they would accept to participate in the study. If they would, each patient was explained the questionnaire and given 20 to 30 minutes to complete it.

Statistical analysis

IBM SPSS Statistics (RRID: SCR_016479) version 27 software for Microsoft Windows was used throughout the statistical analysis process. The participants and disease were calculated by descriptive statistics (means, standards deviations, frequencies and percentages). Because the continuous variables were not normally distributed, non-parametric tests were used for the differential analyses. Spearman correlation was used to measure the correlations of LMQ domains with the SELENA-SLEDAI Score. The impact of a patient’s demographic on MRB was evaluated using the Mann-Whitney and Kruskal-Wallis tests. P-values below 0.05 were regarded as statistically significant.

Results

The study recruited 156 SLE patients Figure 1.⁶² 95.5% of the study participants living in urban cities. The patient’s age was 35.8 ±11.7 years old on average. 96.8% of the population were women, and 71.8% of them were married. More than two-thirds (68%) had primary or secondary school degrees, and 66.7% had a middle income, as shown in Table 1.

Figure 1. Study participant flowchart.

Table 1. The sociodemographic characteristics of the patients.

	Subcategory	Frequency (N)		%
Gender	Male	5		3.2
Gender	Female	151		96.8
Education level	Illiterate	31		19.9
	Primary school	53		34
	Secondary school	53		34
	College degree	19		12.2
Social status	Single	32		20.5
	Married	112		71.8
	Divorced	9		5.8
	Widowed	3		1.9
Living Place	Urban	149		95.5
Living Place	Rural	7		4.5
Monthly income (Iraqi dinars)	< 0.5 million	49		31.4
	0.5-1.0 million	104		66.7
	> 1.0 million	3		1.9
Cigarette smokers	Yes	6		3.8
Cigarette smokers	No	150		96.2
Alcohol drinker	Yes	-----		-----
Alcohol drinker	No	156		100.0
Age (years)	Minimum	Maximum	Mean	Std. Dev.
Age (years)	18	69	35.76	11.66

The mean SELENA-SLEDAI value was 15.26 ± 10.199, the mean disease duration was 6.248 ± 5.44 years, no. of chronic medications was 4.6 ± 2.23, no. of other chronic diseases was 0.62 ± 0.85 as shown in (Table 2).

Table 2. Disease characteristics of the patients.

Variables	Mean (SD)
Disease duration (years) (mean ± SD)	6.248 (5.44)
Number of chronic medications (mean ± SD)	4.6 (2.23)
Number of other chronic diseases (mean ± SD)	0.62 (0.85)
SELENA-SLEDAI value (mean ± SD)	15.26 (10.199)

The mean LMQ score was 117.30 ± 18.37 (Range: 52-163). The findings showed that the majority of the SLE patients experienced a moderate degree of medication burden (69.87%), followed by minimum burden (19.87%) and high burden (7.69%). Finally, no burden at all (2.56%), with no patient experiencing an extremely high burden (0.0 %), as illustrated in Table 3.

Table 3. Perceived MRB using LMQ in patients with SLE (N = 156).

LMQ overall Score (mean ± SD)	117.30 ± 18.37
Degree of burden	Frequency (%)
No burden at all (41–73)	4 (2.56%)
Minimum burden (74 –106)	31 (19.87%)
A moderate degree of burden (107–139)	109 (69.87%)
High burden (140–172)	12 (7.69%)
Extremely high burden (173–205)	--

Two LMQ domains had the lowest mean of burden scores (below the average): domain-1 [relationships with health care professionals (HCPs)] and domain-5 (effectiveness of prescribed medications). In other words, the patients had good relationships with their HCPs and reasonable belief in their medication effectiveness, reducing their MRB in these two domains. On the other hand, three domains had the highest mean of burden scores: Domain-2 (practical difficulties in using medicines), Domain-6 (concerns about medicine use), and Domain-7 (impact of using medications on daily life). In other words, the patients had relatively great difficulties in using medicines and had concerns about medicine use and their prescriptions impact their everyday life, as illustrated in Table 4.

Table 4. Descriptive statistics of LMQ domains.

LMQ domain	Min.	Max.	Mean	S. D
Domain1: Relationships with HCPs	5.00	17.00	7.03	2.51
Domain 2: Practical Difficulties in Using Medicines	9.00	32.00	22.07	4.17
Domain 3: Cost-Related Burden	4.00	15.00	10.49	2.05
Domain 4: Side Effects of Medicines	4.00	20.00	13.77	3.78
Domain 5: Effectiveness of prescribed medications	6.00	25.00	10.90	4.64
Domain 6: Concerns about Medicines Use	11.00	34.00	24.40	4.51
Domain 7: Impact of Using Medicines on Daily Life	8.00	28.00	19.65	3.79
Domain 8: Autonomy to Vary Regimen	3.00	14.00	8.99	3.00

Six domains of LMQ (domains 2, 3, 4, 5, 6, and 7) had significant (P-value <0.05) positive correlations with the SELENA-SLEDAI score. In other words, when the scores of these six LMQ domains increase, the scores of SELENA-SLEDAI increase. In contrast, Domain-1 (relationships with HCPs) and Domain-8 (autonomy to vary regimen) had non-significant (P-value ˃0.05) correlations with the SELENA-SLEDAI score as illustrated in (Table 5).

Table 5. The correlations among LMQ domains and SELENA-SLEDAI score.

LMQ Domains		SELENA-SEDAI
Domain 1: Relationships with HCPs	Correlation Coefficient	0.077
Domain 1: Relationships with HCPs	P-value	0.337
Domain 2: Practical difficulties in using medicines	Correlation Coefficient	0.487
Domain 2: Practical difficulties in using medicines	P-value	0.000*
Domain 3: Cost-related burden	Correlation Coefficient	0.251
Domain 3: Cost-related burden	P-value	0.002*
Domain 4: Side effects of medicines	Correlation Coefficient	0.517
Domain 4: Side effects of medicines	P-value	0.000*
Domain 5: Effectiveness of prescribed medications	Correlation Coefficient	0.330
Domain 5: Effectiveness of prescribed medications	P-value	0.000*
Domain 6: Concerns about medicine use	Correlation Coefficient	0.381
Domain 6: Concerns about medicine use	P-value	0.000*
Domain 7: Impact of using medicines on daily life	Correlation Coefficient	0.491
Domain 7: Impact of using medicines on daily life	P-value	0.000*
Domain 8: Autonomy to vary regimen	Correlation Coefficient	0.082
Domain 8: Autonomy to vary regimen	P-value	0.311

According to Mann-Whitney test, there were no significant differences in MRB (total LMQ score) according to eight demographic and clinical characteristics (Table 6A). However, according to Kruskal-Wallis test, there was a significant difference in the total LMQ score according to the patient’s income. The higher-income patient had significantly lower MRB (total LMQ score) compared to low-income patients (Table 6B).

Table 6A. Influence of patients’ demographic and clinical characteristics on medication burden.

Medication Burden	Gender	N	Mean Rank	P-value
Total LMQ score	Male	5	77.60	0.964
Total LMQ score	Female	151	78.53	0.964
	Social status	N	Mean Rank
Total LMQ score	Without spouse	44	79.10	0.917
Total LMQ score	Married	112	78.26	0.917
	Address	N	Mean Rank
Total LMQ score	Urban	149	77.90	0.443
Total LMQ score	Rural	7	91.29	0.443
	Smoker	N	Mean Rank
Total LMQ score	Yes	6	101.25	0.208
Total LMQ score	No	150	77.59	0.208
	Chronic disease	N	Mean Rank
Total LMQ score	No	85	78.40	0.976
Total LMQ score	Yes	71	78.62	0.976
	Chronic medications	N	Mean Rank
Total LMQ score	≤ 5	116	76.41	0.582
Total LMQ score	> 5	40	84.56	0.582
	Disease duration	N	Mean Rank
Total LMQ score	≤ 5 years	91	77.49	0.741
Total LMQ score	> 5 years	65	79.92	0.741
	Age category	N	Mean Rank
Total LMQ score	≤ 40 years	97	82.02	0.212
Total LMQ score	40 > years	59	72.71	0.212

Table 6B. Influence of Patient’s Demographic on Medication Burden.

	Monthly income (ID)	N	Mean Rank	P-value
Total LMQ score	˂ 0.5 million ID	49	92.90	0.015*
	0.5-1.0 million ID	104	72.69
	>1.0 million ID	3	44.67

	Education level	N	Mean Rank	P-value
Total LMQ score	Illiterate	31	71.60	0.262
	Primary school	53	88.13
	Secondary school	53	76.00
	University	19	69.87

* Significant (P-value <0.05) according to Kruskal-Wallis Test.

LMQ: Living with Medicine Questionnaire.

Discussion

Systemic lupus erythematosus is a chronic, prototypic autoimmune disorder that may affect almost any organ or system.¹³ SLE continues to carry an unacceptably high morbidity burden.¹⁴ However, over the past 50 years, patient survival has drastically increased, probably due to earlier diagnosis and more effective treatment plans.¹⁵ This study measured MRB and assessed any associations between the MRB and various patient-related factors. As shown in sociodemographic data of the patients, about (96.8%) of patients were female. Nearly 80% of autoimmune disease patients are female, which brings attention to the gender disparity.¹⁶

According to our study, a significant number of the participants (97.44%) had varying degrees of MRB. For patients and their families, chronic rheumatic diseases such as rheumatoid arthritis (RA), ankylosing spondylitis (AS), and SLE are very burdensome.¹⁷^–²¹ In addition, patients who had organ failure (such as lupus nephritis), disease flare-ups, high disease activity, and chronic disease are more burdened.²²

The current study showed that the mean LMQ score was 117.30 ± 18.37 with the majority of the participants reporting experiencing minimum (19.87%) to moderate (69.87%) MRB. According to the recent increase of interest in understanding and quantifying MRB, there is currently no study measuring MRB among SLE patients to compare our results. Most of the available studies included patients with chronic diseases in general. The results of the current study differ from those in Qatar,⁸ where the MRB ranged from minimal (66.8%) to moderate (24.1%) degrees of burden while being comparable to those in England²³: minimal (33.1%) to moderate (54.6%); and in Kuwait⁹ that ranged from minimal (35.4%) to moderate (62.0%) degrees of burden.

The three domains with the highest mean burden scores were (practical difficulties in using medications), (concerns about the use of drugs), and (the impact of using medicines on daily life). The results are consistent with recent qualitative research that examined patient perceptions on treatment and MRB and showed that medication use could impair relationships, work, and social relationships and have adverse physiological effects.²⁴^,²⁵ In addition, patients are burdened more by dealing with their drugs’ harmful effects and adjusting their daily routines to meet the requirements of their therapeutic regimens.²⁶^–²⁸

In the current study, two LMQ domains had the lowest mean of burden scores: (relationships with HCPs) and (the effectiveness of prescribed medications). In other words, the patients had good relationships with their HCPs and reasonable belief in their medication effectiveness, reducing their MRB in these two domains. To make appropriate therapy decisions, developing a connection between the patient and the HCP can allow collaborative discussions²⁹^,³⁰ to assist practitioners in identifying the specific MRB observed and understanding the actual lived experiences of the patient. Improvements in patient knowledge, satisfaction, and therapeutic and health outcomes were made possible by the value of two-way patient-provider interactions where patients’ experiences are discussed and shared decisions.²⁹^,³¹ Across studies, people’s good attitude toward medications could be seen.³²^–³⁴ Positive attitudes were primarily associated with trust in healthcare professionals, positive drug experiences, and achieving anticipated therapeutic goals.³²^–³⁶

Six domains of LMQ (practical difficulties, cost, side effects, effectiveness of prescribed medications, concerns regarding medication use, and the effect of medication use on daily life) correlated positively with the SELENA-SLEDAI score. In addition, treatment burden was associated with several adverse health outcomes, including specific symptoms,³⁷^,³⁸ recurrence of disease,³⁹^–⁴¹ decline in health,³⁸^,⁴⁰ reduced survival,⁴¹ decreased treatment satisfaction⁴² and reduced quality of life.⁴³^,⁴⁴

Age, gender, marital status, place of residence, smoking, the number of drugs one takes, comorbidities, the length of the disease, and level of education were unrelated to MRB (P> 0.05 for all comparisons). The results of the current study do not match the results of many previous studies. Age and treatment burden showed a significant relationship. Given the likelihood of illness and various disorders, older persons appeared to have a higher treatment burden than younger people.³⁷^,⁴⁴^,⁴⁵ Chronic conditions such as diabetes⁴⁶ were associated with a more significant treatment burden. Longer illness duration in diabetic patients was linked to lower burden.⁴⁷ Using many medications³⁸^,⁴⁸^–⁵² emerged as the most common predictor of commitment. In addition, the low education level was associated with a higher medication burden.⁵³

Patients with higher income had significantly lower MRB (total LMQ score) compared to low-income patients. Rheumatic diseases are frequently treated with many drug combinations, contributing to the patient’s burden of high medical costs.⁵⁴ As a result, patients on the border of poverty are more likely to stop taking their drugs due to financial difficulties.⁵⁵^–⁶¹

Limitations

When interpreting the findings of this study, a few potential limitations should be considered. The first thing to remember was the limited patient population, partially due to rheumatic disorders’ rarity. Second, self-selection and recall bias was probably present in the results obtained from self-report questionnaires. Third, all participants were recruited from one center. Finally, it is crucial to replicate this study with a larger sample size because our patients might not be representative of Iraqi patients overall. Another limitation is the cross-sectional nature of the data, which was presented at a specific time and does not account for changes in participants’ lived experiences regarding medication usage and adherence over time.

Conclusions

A significant number of the SLE patients in this research had MRB, with the majority of participants reporting a medium level of burden. According to the present research results, HCPs should be aware of the influence of treatment strategies on the lives of SLE patients. Furthermore, healthcare professionals must develop initiatives to reduce this burden, particularly amongst low-income populations.

Data availability

Underlying data

Zenodo: Demographic data along with questionnaires responses. https://doi.org/10.5281/zenodo.6941308.⁶²

This project contains the following underlying data:

- Article’s data.xlsx (Demographic data along with questionnaires 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 Baghdad Teaching Hospital/Consultation Clinic team for their continuous support during data collection and patient interviews.

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Version 2

VERSION 2 PUBLISHED 23 Aug 2022

Author details Author details

Hawraa Kadhim Abbas
Roles: Conceptualization, Data Curation, Formal Analysis, Funding Acquisition, Investigation, Methodology, Project Administration, Writing – Original Draft Preparation

Dheyaa Jabbar Kadhim
Roles: Conceptualization, Methodology, Project Administration, Supervision, Validation, Visualization

Faiq Isho Gorial
Roles: Investigation, Methodology, Software, Supervision, Validation, Visualization, Writing – Review & Editing

Laith G. Shareef
Roles: Resources, Software, 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.

Article Versions (2)

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Published: 01 Nov 2022, 11:970

https://doi.org/10.12688/f1000research.124698.2

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Published: 23 Aug 2022, 11:970

https://doi.org/10.12688/f1000research.124698.1

© 2022 Kadhim Abbas H 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.

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Kadhim Abbas H, Jabbar Kadhim D, Isho Gorial F and Shareef LG. Assessment of medication-related burden among a sample of Iraqi patients with systemic lupus erythematosus and its relationship with disease activity: a cross-sectional study [version 1; peer review: 1 approved with reservations]. F1000Research 2022, 11:970 (https://doi.org/10.12688/f1000research.124698.1)

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Reviewer Report 27 Sep 2022

Bridget Hodkinson, Division of Rheumatology, Department of Medicine, Groote Schuur Hospital, University of Cape Town, Cape Town, South Africa

Approved with Reservations

https://doi.org/10.5256/f1000research.136920.r149919

This paper measured medication-related burden amongst Iraqi SLE patients and showed moderate burden, particularly in areas of practical difficulties in using medications, concerns about the use of drugs, and the impact of using medicines on daily life. This is an ... Continue reading

How did “illiterate” patients complete the questionnaire? Almost 20% of your patients are illiterate according to your data.
Table 6B shows that patients with a lower monthly income had significantly higher MRB scores. In the discussion, you assume this is due to financial constraints causing pts to stop meds. Do you have evidence for this? Suggest looking at individual domains affected by income to defend your interpretation. Other reasons may be true also.
Are you able to comment on SLE organ involvement (e.g. nephritis, NPSLE) effects on MRB rather than just the summation score? See your ref 22. If not mention this as a limitation.

There are a few grammatical/style errors that need addressing:

The use of brackets midsentence, e.g. pg 7 - "…(practical difficulties in using medications), (concerns about the use of drugs), and (the impact of using medicines on daily life)."
Also, paragraph 1 of the discussion needs refining – avoid words like “unacceptably” and “drastically – these are not used in scientific writing.
Revise “about (96.8%) of patients”, say over 96% were female or the vast majority (96.8%) were female.
Clean up the repetitive headings of Table 6A and B, make another column for p-value in Table 5 and delete the rows of the p-value. Remove column 1 from Table 6.
Combine Tables 3 and 4.

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

Yes
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?

Yes
Are the conclusions drawn adequately supported by the results?

Partly

Competing Interests: No competing interests were disclosed.

Reviewer Expertise: Rheumatology

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.

CITE

Report a concern

Author Response 01 Nov 2022

Laith G. Shareef, Department of Pharmacy, Al-Esraa University College, Baghdad, 10011, Iraq

01 Nov 2022

Author Response

1. How did “illiterate” patients complete the questionnaire? Almost 20% of your patients are illiterate according to your data.

Answer:
After obtaining the patient's permission to participate in the ... Continue reading 1. How did “illiterate” patients complete the questionnaire? Almost 20% of your patients are illiterate according to your data.

Answer:
After obtaining the patient's permission to participate in the research, we interviewed them in a dedicated room in the rheumatology unit, explained each item in the questionnaire, acquired the patient's degree of reaction, and noted it in the questionnaire.

2. Table 6B shows that patients with a lower monthly income had significantly higher MRB scores. In the discussion, you assume this is due to financial constraints causing pts to stop meds. Do you have evidence for this? Suggest looking at individual domains affected by income to defend your interpretation. Other reasons may be true also.

Answer:
Because rheumatic diseases are frequently treated with many drug combinations, which contributes to the patient's burden of high medical costs, when we looked at two items of cost-related burden domain: "I worry about paying for my medicines. I have to pay more than I can afford for my medicines", in these items the mean of burden score higher than the average, in other words, those patients were more worried about paying for their medicines, and they paid for their medicines more than they can afford, leading to increase the burden of medicines on patients with low monthly income and contribute to an inadequate level of adherence.

3. Are you able to comment on SLE organ involvement (e.g., nephritis, NPSLE) effects on MRB rather than just the summation score? See your ref 22. If not mention this as a limitation.

Answer:
We cannot comment on the effects of SLE organ involvement (e.g., nephritis, NPSLE) on MRB; this needs further study; we can determine it as a limitation in the current study.

There are a few grammatical/style errors that need addressing:
1- The use of brackets midsentence, e.g. pg 7 - "(practical difficulties in using medications), (concerns about the use of drugs), and (the impact of using medicines on daily life)."

Answer:
The new version includes the requested adjustments.

2- Also, paragraph 1 of the discussion needs refining – avoid words like “unacceptably” and “drastically – these are not used in scientific writing.

Answer:
The new version includes the requested adjustments.

3- Revise “about (96.8%) of patients”, say over 96% were female or the vast majority (96.8%) were female.

Answer:
The new version includes the requested adjustments.

4- Clean up the repetitive headings of Table 6A and B, make another column for p-value in Table 5 and delete the rows of the p-value. Remove column 1 from Table 6.

Answer:
The new version includes the requested adjustments.

5- Combine Tables 3 and 4.

Answer:
The new version includes the requested adjustments.
1. How did “illiterate” patients complete the questionnaire? Almost 20% of your patients are illiterate according to your data.

Answer:
After obtaining the patient's permission to participate in the research, we interviewed them in a dedicated room in the rheumatology unit, explained each item in the questionnaire, acquired the patient's degree of reaction, and noted it in the questionnaire.

2. Table 6B shows that patients with a lower monthly income had significantly higher MRB scores. In the discussion, you assume this is due to financial constraints causing pts to stop meds. Do you have evidence for this? Suggest looking at individual domains affected by income to defend your interpretation. Other reasons may be true also.

Answer:
Because rheumatic diseases are frequently treated with many drug combinations, which contributes to the patient's burden of high medical costs, when we looked at two items of cost-related burden domain: "I worry about paying for my medicines. I have to pay more than I can afford for my medicines", in these items the mean of burden score higher than the average, in other words, those patients were more worried about paying for their medicines, and they paid for their medicines more than they can afford, leading to increase the burden of medicines on patients with low monthly income and contribute to an inadequate level of adherence.

3. Are you able to comment on SLE organ involvement (e.g., nephritis, NPSLE) effects on MRB rather than just the summation score? See your ref 22. If not mention this as a limitation.

Answer:
We cannot comment on the effects of SLE organ involvement (e.g., nephritis, NPSLE) on MRB; this needs further study; we can determine it as a limitation in the current study.

There are a few grammatical/style errors that need addressing:
1- The use of brackets midsentence, e.g. pg 7 - "(practical difficulties in using medications), (concerns about the use of drugs), and (the impact of using medicines on daily life)."

Answer:
The new version includes the requested adjustments.

2- Also, paragraph 1 of the discussion needs refining – avoid words like “unacceptably” and “drastically – these are not used in scientific writing.

Answer:
The new version includes the requested adjustments.

3- Revise “about (96.8%) of patients”, say over 96% were female or the vast majority (96.8%) were female.

Answer:
The new version includes the requested adjustments.

4- Clean up the repetitive headings of Table 6A and B, make another column for p-value in Table 5 and delete the rows of the p-value. Remove column 1 from Table 6.

Answer:
The new version includes the requested adjustments.

5- Combine Tables 3 and 4.

Answer:
The new version includes the requested adjustments.
Competing Interests: No competing interests were disclosed. Close
Report a concern
Respond or Comment

COMMENTS ON THIS REPORT

Author Response 01 Nov 2022

Laith G. Shareef, Department of Pharmacy, Al-Esraa University College, Baghdad, 10011, Iraq

01 Nov 2022

Author Response

1. How did “illiterate” patients complete the questionnaire? Almost 20% of your patients are illiterate according to your data.

Answer:
After obtaining the patient's permission to participate in the ... Continue reading 1. How did “illiterate” patients complete the questionnaire? Almost 20% of your patients are illiterate according to your data.

Answer:
After obtaining the patient's permission to participate in the research, we interviewed them in a dedicated room in the rheumatology unit, explained each item in the questionnaire, acquired the patient's degree of reaction, and noted it in the questionnaire.

2. Table 6B shows that patients with a lower monthly income had significantly higher MRB scores. In the discussion, you assume this is due to financial constraints causing pts to stop meds. Do you have evidence for this? Suggest looking at individual domains affected by income to defend your interpretation. Other reasons may be true also.

Answer:
Because rheumatic diseases are frequently treated with many drug combinations, which contributes to the patient's burden of high medical costs, when we looked at two items of cost-related burden domain: "I worry about paying for my medicines. I have to pay more than I can afford for my medicines", in these items the mean of burden score higher than the average, in other words, those patients were more worried about paying for their medicines, and they paid for their medicines more than they can afford, leading to increase the burden of medicines on patients with low monthly income and contribute to an inadequate level of adherence.

3. Are you able to comment on SLE organ involvement (e.g., nephritis, NPSLE) effects on MRB rather than just the summation score? See your ref 22. If not mention this as a limitation.

Answer:
We cannot comment on the effects of SLE organ involvement (e.g., nephritis, NPSLE) on MRB; this needs further study; we can determine it as a limitation in the current study.

There are a few grammatical/style errors that need addressing:
1- The use of brackets midsentence, e.g. pg 7 - "(practical difficulties in using medications), (concerns about the use of drugs), and (the impact of using medicines on daily life)."

Answer:
The new version includes the requested adjustments.

2- Also, paragraph 1 of the discussion needs refining – avoid words like “unacceptably” and “drastically – these are not used in scientific writing.

Answer:
The new version includes the requested adjustments.

3- Revise “about (96.8%) of patients”, say over 96% were female or the vast majority (96.8%) were female.

Answer:
The new version includes the requested adjustments.

4- Clean up the repetitive headings of Table 6A and B, make another column for p-value in Table 5 and delete the rows of the p-value. Remove column 1 from Table 6.

Answer:
The new version includes the requested adjustments.

5- Combine Tables 3 and 4.

Answer:
The new version includes the requested adjustments.
1. How did “illiterate” patients complete the questionnaire? Almost 20% of your patients are illiterate according to your data.

Answer:
After obtaining the patient's permission to participate in the research, we interviewed them in a dedicated room in the rheumatology unit, explained each item in the questionnaire, acquired the patient's degree of reaction, and noted it in the questionnaire.

2. Table 6B shows that patients with a lower monthly income had significantly higher MRB scores. In the discussion, you assume this is due to financial constraints causing pts to stop meds. Do you have evidence for this? Suggest looking at individual domains affected by income to defend your interpretation. Other reasons may be true also.

Answer:
Because rheumatic diseases are frequently treated with many drug combinations, which contributes to the patient's burden of high medical costs, when we looked at two items of cost-related burden domain: "I worry about paying for my medicines. I have to pay more than I can afford for my medicines", in these items the mean of burden score higher than the average, in other words, those patients were more worried about paying for their medicines, and they paid for their medicines more than they can afford, leading to increase the burden of medicines on patients with low monthly income and contribute to an inadequate level of adherence.

3. Are you able to comment on SLE organ involvement (e.g., nephritis, NPSLE) effects on MRB rather than just the summation score? See your ref 22. If not mention this as a limitation.

Answer:
We cannot comment on the effects of SLE organ involvement (e.g., nephritis, NPSLE) on MRB; this needs further study; we can determine it as a limitation in the current study.

There are a few grammatical/style errors that need addressing:
1- The use of brackets midsentence, e.g. pg 7 - "(practical difficulties in using medications), (concerns about the use of drugs), and (the impact of using medicines on daily life)."

Answer:
The new version includes the requested adjustments.

2- Also, paragraph 1 of the discussion needs refining – avoid words like “unacceptably” and “drastically – these are not used in scientific writing.

Answer:
The new version includes the requested adjustments.

3- Revise “about (96.8%) of patients”, say over 96% were female or the vast majority (96.8%) were female.

Answer:
The new version includes the requested adjustments.

4- Clean up the repetitive headings of Table 6A and B, make another column for p-value in Table 5 and delete the rows of the p-value. Remove column 1 from Table 6.

Answer:
The new version includes the requested adjustments.

5- Combine Tables 3 and 4.

Answer:
The new version includes the requested adjustments.
Competing Interests: No competing interests were disclosed. Close
Report a concern

Comments on this article Comments (0)

Version 2

VERSION 2 PUBLISHED 23 Aug 2022

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Version 2 (revision) 01 Nov 22
Version 1 23 Aug 22	read

Bridget Hodkinson, University of Cape Town, Cape Town, South Africa

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Reviewer Report

28 Views

27 Sep 2022 | for Version 1

Bridget Hodkinson, Division of Rheumatology, Department of Medicine, Groote Schuur Hospital, University of Cape Town, Cape Town, South Africa

28 Views Cite this report Responses(1)

Approved With Reservations

How did “illiterate” patients complete the questionnaire? Almost 20% of your patients are illiterate according to your data.
Table 6B shows that patients with a lower monthly income had significantly higher MRB scores. In the discussion, you assume this is due to financial constraints causing pts to stop meds. Do you have evidence for this? Suggest looking at individual domains affected by income to defend your interpretation. Other reasons may be true also.
Are you able to comment on SLE organ involvement (e.g. nephritis, NPSLE) effects on MRB rather than just the summation score? See your ref 22. If not mention this as a limitation.

There are a few grammatical/style errors that need addressing:

The use of brackets midsentence, e.g. pg 7 - "…(practical difficulties in using medications), (concerns about the use of drugs), and (the impact of using medicines on daily life)."
Also, paragraph 1 of the discussion needs refining – avoid words like “unacceptably” and “drastically – these are not used in scientific writing.
Revise “about (96.8%) of patients”, say over 96% were female or the vast majority (96.8%) were female.
Clean up the repetitive headings of Table 6A and B, make another column for p-value in Table 5 and delete the rows of the p-value. Remove column 1 from Table 6.
Combine Tables 3 and 4.

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

Yes
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?

Yes
Are the conclusions drawn adequately supported by the results?

Partly

Competing Interests

No competing interests were disclosed.

Reviewer Expertise

Rheumatology

Respond to this report

Responses (1)

Author Response

01 Nov 2022

Laith G. Shareef, Department of Pharmacy, Al-Esraa University College, Baghdad, 10011, Iraq

1. How did “illiterate” patients complete the questionnaire? Almost 20% of your patients are illiterate according to your data.

Answer:
After obtaining the patient's permission to participate in the research, we interviewed them in a dedicated room in the rheumatology unit, explained each item in the questionnaire, acquired the patient's degree of reaction, and noted it in the questionnaire.

2. Table 6B shows that patients with a lower monthly income had significantly higher MRB scores. In the discussion, you assume this is due to financial constraints causing pts to stop meds. Do you have evidence for this? Suggest looking at individual domains affected by income to defend your interpretation. Other reasons may be true also.

Answer:
Because rheumatic diseases are frequently treated with many drug combinations, which contributes to the patient's burden of high medical costs, when we looked at two items of cost-related burden domain: "I worry about paying for my medicines. I have to pay more than I can afford for my medicines", in these items the mean of burden score higher than the average, in other words, those patients were more worried about paying for their medicines, and they paid for their medicines more than they can afford, leading to increase the burden of medicines on patients with low monthly income and contribute to an inadequate level of adherence.

3. Are you able to comment on SLE organ involvement (e.g., nephritis, NPSLE) effects on MRB rather than just the summation score? See your ref 22. If not mention this as a limitation.

Answer:
We cannot comment on the effects of SLE organ involvement (e.g., nephritis, NPSLE) on MRB; this needs further study; we can determine it as a limitation in the current study.

There are a few grammatical/style errors that need addressing:
1- The use of brackets midsentence, e.g. pg 7 - "(practical difficulties in using medications), (concerns about the use of drugs), and (the impact of using medicines on daily life)."

Answer:
The new version includes the requested adjustments.

2- Also, paragraph 1 of the discussion needs refining – avoid words like “unacceptably” and “drastically – these are not used in scientific writing.

Answer:
The new version includes the requested adjustments.

3- Revise “about (96.8%) of patients”, say over 96% were female or the vast majority (96.8%) were female.

Answer:
The new version includes the requested adjustments.

4- Clean up the repetitive headings of Table 6A and B, make another column for p-value in Table 5 and delete the rows of the p-value. Remove column 1 from Table 6.

Answer:
The new version includes the requested adjustments.

5- Combine Tables 3 and 4.

Answer:
The new version includes the requested adjustments.

View more View less

Competing Interests

No competing interests were disclosed.

Alongside their report, reviewers assign a status to the article:

Approved - the paper is scientifically sound in its current form and only minor, if any, improvements are suggested

Approved with reservations - A number of small changes, sometimes more significant revisions are required to address specific details and improve the papers academic merit.

Not approved - fundamental flaws in the paper seriously undermine the findings and conclusions

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Assessment of medication-related burden among a sample of Iraqi patients with systemic lupus erythematosus and its relationship with disease activity: a cross-sectional study

Abstract

Keywords

Introduction

Methods

Ethical approval

Study design

Setting

Sample size

Eligibility criteria

Exclusion criteria

Bias

The questionnaires

Administration of questionnaires

Statistical analysis

Results

Figure 1. Study participant flowchart.

Table 1. The sociodemographic characteristics of the patients.

Table 2. Disease characteristics of the patients.

Table 3. Perceived MRB using LMQ in patients with SLE (N = 156).

Table 4. Descriptive statistics of LMQ domains.

Table 5. The correlations among LMQ domains and SELENA-SLEDAI score.

Table 6A. Influence of patients’ demographic and clinical characteristics on medication burden.

Table 6B. Influence of Patient’s Demographic on Medication Burden.

Discussion

Limitations

Conclusions

Data availability

Underlying data

Acknowledgments

References

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