Health-Related Quality of Life Among Warfarin Using Clients in a Cardiac Centre: A Cross-sectional Descriptive Study

Sapana Pokhrel; Mandira Onta; Ranjita Karmacharya; Avilasha Bhagat; Prem Shankar Chaurasiya

doi:10.12688/f1000research.147174.1

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Research Article

Health-Related Quality of Life Among Warfarin Using Clients in a Cardiac Centre: A Cross-sectional Descriptive Study

[version 1; peer review: awaiting peer review]

Sapana Pokhrel ¹, Mandira Onta², Ranjita Karmacharya³, Avilasha Bhagat⁴, Prem Shankar Chaurasiya ⁵

Sapana Pokhrel ¹, Mandira Onta², [...] Ranjita Karmacharya³, Avilasha Bhagat⁴, Prem Shankar Chaurasiya ⁵

PUBLISHED 24 Jun 2024

Author details Author details

¹ Internal Medicine, Civil Service Hospital, Kathmandu, Bagmati, Nepal
² Internal Medicine, Institute of medicine, Tribhuwan University, Kathmandu, Bagmati, Nepal
³ Tribhuvan University, Institute of Medicine, Pokhara Nursing Campus, Pokhara,, Pokhara, Nepal
⁴ Internal Medicine, National Medical College, Birgunj, Madhesh, Nepal
⁵ Internal Medicine, Kalaiya Hospital, Kalaiya, Madhesh, Nepal

Sapana Pokhrel
Roles: Funding Acquisition, Investigation, Methodology

Mandira Onta
Roles: Project Administration, Resources, Software

Ranjita Karmacharya
Roles: Supervision, Validation, Writing – Review & Editing

Avilasha Bhagat
Roles: Visualization, Writing – Original Draft Preparation

Prem Shankar Chaurasiya
Roles: Conceptualization, Data Curation, Formal Analysis

OPEN PEER REVIEW

REVIEWER STATUS AWAITING PEER REVIEW

Abstract

Background

Warfarin is an oral anticoagulant with strict therapeutic levels, dietary restrictions, and drug interactions that play a significant role in the physical, psychological, and social well-being of clients throughout their lives. Thus, the study aimed to assess the HRQoL of warfarin using clients in a cardiac Centre.

Methods

A cross-sectional descriptive study design was carried out among 270 clients from 10th February to 10th March 2021 in the outpatient department of Manmohan Cardiothoracic, Vascular and Transplant Centre, Nepal. Ethical approval was taken from the Institutional Review Committee, Institute of Medicine (Reference no. 261/2021). A non-probability purposive sampling technique was followed. Data was collected through a structured Interview Schedule by using the WHO QOL-BREF version questionnaire. Variables were coded, entered in EPI-DATA version 3.1, and then transferred to SPSS 16 for descriptive and inferential statistical analysis.

Results

The mean score for overall quality of life was 55.60±10.25. More than half of the clients (64.8%) had a moderate level of quality of life. The mean scores for the physical, psychological, social, and environmental domains were 47.08±14.39, 56.50±14.35, 64.17±11.50, and 54.65±12.25 respectively. A statistically significant association between age (p=.015), sex (p=.007), socio-economic class (p≤.001), and comorbidities (p=.002) with overall quality of life was observed. Strong positive correlation was observed between physical (r=.768, p≤.001), psychological (r=.794, p≤.001), environmental domain (r=.777, p≤.001) with overall quality of life.

Conclusions

This study concluded that the warfarin-using clients had moderate mean scores of WHOQOL-BREF. The physical domain was the most compromised one and age, sex, socioeconomic class, and comorbidities in clients were significantly associated with overall quality of life. Therefore, it is necessary to conduct an awareness program for healthcare care professionals and family members regarding the physical, psychological, social, and environmental health of warfarin using clients to improve their quality of life.

Keywords

Clients, Comorbidities, Health-related Quality of Life, Transplant, Warfarin

Corresponding authors: Sapana Pokhrel, Prem Shankar Chaurasiya

Competing interests: No competing interests were disclosed.

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

Copyright: © 2024 Pokhrel S 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: Pokhrel S, Onta M, Karmacharya R et al. Health-Related Quality of Life Among Warfarin Using Clients in a Cardiac Centre: A Cross-sectional Descriptive Study [version 1; peer review: awaiting peer review]. F1000Research 2024, 13:681 (https://doi.org/10.12688/f1000research.147174.1) First published: 24 Jun 2024, 13:681 (https://doi.org/10.12688/f1000research.147174.1) Latest published: 24 Jun 2024, 13:681 (https://doi.org/10.12688/f1000research.147174.1)

Introduction

Rheumatic Heart Disease (RHD) prevalence is 10.2 per 1,000 children and increases with advancing age, with 35.3% of high-risk eligible patients of RHD treated with warfarin. The government has decided to provide free valve replacement surgery to all patients suffering from RHD to strengthen their quality of life.¹

Annually, in average 700 valve replacement surgeries are done among two major cardiac centers including Manmohan Cardiothoracic Vascular and Transplant Center and all the patients after valve replacement surgery receive warfarin to prevent thromboembolic complications.²

Warfarin became the most recommended oral anticoagulant for the prevention of thrombo-embolism immediately after its introduction in the 1950s, especially in patients with deep vein thrombosis, atrial fibrillation, stroke prophylaxis including prosthetic heart valve replacement. Warfarin is highly effective in treating these diseases, but it may be hard to maintain the target of the International Normalized Ratio (INR) range. Therefore, there is a risk of over- and under-anticoagulation.³^,⁴

Warfarin became the most recommended oral anticoagulant for the prevention of thrombo-embolism immediately after its introduction in the 1950s, especially in patients with deep vein thrombosis, atrial fibrillation, stroke prophylaxis including prosthetic heart valve replacement. Warfarin is highly effective in treating these diseases, but it may be hard to maintain the target of the International Normalized Ratio (INR) range. Therefore, there is a risk of over- and under-anticoagulation.

Patients under oral anticoagulant therapy require frequent follow-up for testing to control the INR. Additionally, chronic warfarin usage affects their perception of the health-related Quality of Life (HRQoL) as well as their health status due to overall lifestyle modification, dietary restrictions regarding vitamin K, and the fear of compromised physical activity which ultimately results in a negative impact on patient-reported HRQoL.³^,⁵

Treatment with oral anticoagulants like warfarin may influence their health and quality of life due to changes in lifestyle and frequent hospital follow-ups for INR monitoring and dose adjustments. Thus, the objective of the study was to determine the difficulties of patients living with long-term oral anticoagulant therapy via HRQoL assessment.

Methods

Research design and setting

A cross-sectional hospital-based descriptive study was conducted at the outpatient department of Manmohan Cardiothoracic Vascular and Transplant Centre, Maharajgunj, Kathmandu, which is under Tribhuvan University, Institute of Medicine. It is a 100-bed capacity and designated center in the fields of Cardiac, Thoracic, and Vascular treatment in Nepal. It belongs to Bagmati Pradesh which has one of the highest warfarin users following rheumatic heart disease-related valve replacement. The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) guidelines were strictly followed during the study.

Study population

The study population was the clients visiting the outpatient department of Manmohan Cardiothoracic Vascular and Transplant Centre, Kathmandu, and using warfarin therapy.

Sampling technique

Non-probability purposive sampling technique was adopted to select the sample of 270 warfarin-using clients in the study. Clients using warfarin for the last two months were ascertained by checking the Outpatient Department (OPD) card or asking the clients waiting outside the OPD individually and interviewed as a sample unit.

Inclusion criteria

Clients using warfarin medicine for at least two months, age ≥ 18 years, able to consent (both written and verbal) were included in this study.

Ethical consideration

The approval of the research proposal was obtained from the Research Committee of Pokhara Nursing Campus, Tribhuvan University (TU), and ethical clearance from the Institutional Review Committee (IRC) of Tribhuvan University, Kathmandu on feb 2, 2021 ref no. 261/(6-11) E2/077/078 The formal permission was taken from Man Mohan Cardiothoracic Vascular and Transplant Centre (MCTVC) for data collection through a request letter from Pokhara Nursing Campus.

Clients using warfarin medicine for at least two months, age ≥ 18 years, able to consent both written and verbal were included in this study.

The consent was both verbal and written. The participants were initially informed about the nature of the research verbally and then a written consent form was filled out and asked to sign by them if interested.

Sample size calculation

The required sample size for this study was calculated by using the following formula (standard deviation of mean for infinite population).⁶

n = \frac{z α^{2} . σ^{2}}{d^{2}}

Where,

n = Required minimum sample size

Zα = Significant value at α level of significance

σ = Standard deviation

d = Desired level of precision

The sample size was calculated based on the study done in Pakistan using the WHOQoL-BREF tool regarding Health-related quality of life among warfarin using patients having domain mean ± standard deviation of 64.27±26.28.⁷

Applying the above formula in significant value for 95% confidence interval (Zα =1.96) and 5% relative error of the mean was 3.2135,

So, Required sample size

\begin{array}{l} n = {1.96}^{2} {26.28}^{2} / {21.35}^{2} \\ = 256.92 \\ \sim 257 \end{array}

This results in a minimum sample size of 257. After adding a nonresponse rate of 5%, the final sample size was 269.85 = ~270.

Hence, 270 final sample sizes had been calculated and considered for study purposes.

Research instrumentation

A structured interview questionnaire that included demographics, questions related to warfarin, and a brief version of the World Health Organization Quality of Life assessment tool (WHOQoL-BREF, 1996) to assess the health-related quality of life of warfarin-using clients.

WHOQoL-BREF consisted of 26 questions. Each question was rated in a 5-point positive direction (1=very poor, 2=poor, 3=average, 4=good, 5=very good) but questions Q3, Q4, and Q26 were negatively phrased. Higher scores denote higher quality of life. Clients were requested to respond to the questions related to the aspects of life experienced in the last four weeks. Questions 3 to 26 were divided into 4 different domains; the physical domain; the psychological domain; the social relationship domain, and the environmental domain.

Data were analyzed based on the transformed score. All four domains were taken into consideration to evaluate the overall quality of life.

The questionnaire was pre-tested in Shahid Gangalal National Heart Centre in 10% (26 clients) of the minimum required sample size and high internal consistency was found with 0.879 Cronbach’s alpha coefficient. The modification was done only in warfarin-related questions i.e. side effect (menorrhagia) based on findings of pre-testing.

Research method proper

Hospital authorities including the research and nursing departments were briefed about the study. The researcher visited the clients who were waiting outside the OPD. Clients using warfarin (≥2 months) and age ≥18 years were ascertained by checking the Outpatient Department (OPD) card and asking the clients waiting outside the OPD. Each client was explained about the purpose of the study and requested voluntary participation. Both verbal and written consent were taken from participants before conducting the interview. Information from participants was collected by the researcher herself using a structured interview schedule after proper instruction about the questionnaire. Confidentiality was maintained by using code numbers on each questionnaire. The research room was used during the interview to maintain privacy. The average time taken to complete the interview for one participant was approximately 20-25 minutes and each day 10-14 clients were interviewed. The duration of data collection was four weeks from 10 February 2021 to 10 March 2021. The response rate was cent percent. The data was collected on working days.

Statistical analysis

After complete data collection, data was checked for completeness and accuracy. Data was then coded and entered on the same day of data collection. Data was entered using EPI-DATA version 3.1 and transferred into Statistical Package for Social Sciences (SPSS 16 version) for further analysis. Both descriptive and inferential statistics methods were used to analyze the data.

Descriptive statistics were used to evaluate the demographic variables, warfarin-related variables, responses on WHOQoL-BREF items, domain scores, and level of quality of life of the clients. The chi-square test was used to identify the association between the health-related quality of life among warfarin-using clients and selected variables and the correlation coefficient was used to identify the relationship between each domain to overall HRQOL.

Results

Table 1 shows that there were 270 participants of which 58.5 percent were female. The highest percentage of clients (41.9%) fall in the age group 40 to 59 years with an overall mean age ±S.D. is 44.03±14.24. Likewise, 48.5 percent belonged to upper caste, 86.3 percent were married, and 57.8 percent represented urban areas.

Table 1. Socio-demographic characteristics of warfarin using clients.

		n=270
Characteristics	Number	Percent
Age group (In completed Years)
18-39	111	41.1
40-59	113	41.9
60-78	46	17.0
(Mean Age±SD = 44.03±14.24 years, Minimum =18 years and Maximum =78 years)
Sex
Female	158	58.5
Male	112	41.5
Ethnicity
Upper Caste	131	48.5
Disadvantaged janajati	103	38.1
Dalit	17	6.3
Religious minorities	10	3.7
Disadvantaged non dalit tarai caste	9	3.4
Marital status
Married	233	86.3
Unmarried	37	13.7
Place of residence
Urban	156	57.8
Rural	114	42.2

Table 2 depicts that 71.1 percent of the clients were literate. Nearly half (48.1%) of the clients fall under the upper-lower socioeconomic class.

Table 2. Educational and socio-economic status of warfarin using clients.

		n=270
Characteristics	Number	Percent
Education status
Cannot read and write	78	28.9
Can read and write	192	71.1
Level of education (N=192)
Primary school	54	28.1
Middle school certificate	30	15.6
High school certificate	51	26.6
Intermediate or diploma	37	19.3
Graduate or post graduate	19	9.9
Professional or honours	1	0.5
Socioeconomic status
Upper class	2	0.7
Upper middle class	32	11.9
Lower middle class	75	27.8
Upper lower class	130	48.1
Lower class	31	11.5

Table 3 illustrates that the indication of warfarin use in 67 percent of clients was valve replacement, 43.7 percent of clients were using warfarin for more than 5 years, and the side effect of warfarin was not experienced by 83 percent of clients. Among 46 clients having side effects, more than half (52.17%) had menorrhagia.

Table 3. Information on the use of warfarin among warfarin using clients.

		n=270
Variables	Number	Percent
Indication of warfarin use
VR	181	67.0
DVT	44	16.3
RHD	22	8.1
AF	16	5.9
PE	7	2.7
Duration of warfarin use
<1 Year	79	29.3
1-5 Years	73	27.0
>5 Years	118	43.7
Side effects of warfarin
No	224	83
Yes	46	17
*Types of side effects (N=46)**
Menorrhagia (in females)	24	52.17
Severe Haemorrhage	14	30.43
Slight Bruise	5	10.86
Epistaxis	4	8.69
Thrombosis	2	4.34

* Multiple response.

Table 4 shows that 78.1 percent of the clients experienced no comorbidities and for those who experienced comorbidities, 33.9 percent were suffering from HTN. Nearly half of the clients (47.6%) were using <5mg/day as their daily dose of warfarin. More than half of the client’s (50.7%) latest INR level was found deranged i.e. <2 and >3.5.

Table 4. Comorbidities, daily dose and latest INR level of warfarin using clients.

		n=270
Variables	Number	Percent
Comorbidities
No	211	78.1
Yes	59	21.9
Types of comorbidities* (N=59)
HTN	20	33.9
DM	10	16.9
Hypothyroidism	9	15.3
COPD	8	13.6
Arthritis	5	8.5
Prostatomegaly	5	8.5
Others**	10	16.9
Daily dose of warfarin
<5 mg/day	128	47.4
5-7.5 mg/day	123	45.6
>7.5 mg/day	19	7
INR level
<2	107	39.6
2-3.5	133	49.3
>3.5	30	11.1

* Multiple response.

** Others-Renal and Gallbladder Stones, Cancer, Hepatitis, Parkinsonism.

Table 5 depicts that; 34.4 percent of the clients had perceived their poor quality of life while 42.22 percent of clients were satisfied with their general health. Likewise, 56.3 percent of clients expressed a need for more than 3 medicines per day to function in their daily lives and only one client was very satisfied with his work capacity. Similarly, 55.9 percent of clients were satisfied with themselves, and 14.4 percent had always felt negative. Regarding the aspects of the psychological domain, 79.6 percent of clients had good personal relationships whereas 22.6 percent of clients were dissatisfied with their sexual life. Similarly, 71.1 percent of the clients were satisfied with their living place while 42.6 percent only had a little money to meet their health needs.

Table 5. Warfarin user's responses on WHOQoL-BREF items.

						n=270
WHOQoL-BREF Items	Very poor No. (%)	Poor No. (%)	Average No. (%)	Good No. (%)	Very good No. (%)	Mean±SD
Perceived overall QoL and Health Satisfaction
Quality of life	7 (2.6)	93 (34.4)	86 (31.9)	82 (30.4)	2 (.7)	2.92±.882
Health Satisfaction	4 (1.5)	94 (34.8)	55 (20.4)	114 (42.2)	3 (1.1)	3.07±.934
Physical domain
Physical pain	14 (5.2)	102 (37.8)	90 (33.3)	56 (20.7)	8 (3)	2.79±.932
Medication need	16 (5.9)	152 (56.3)	89 (33)	13 (4.8)	0 (0.0)	2.37±.670
Everyday energy	15 (5.6)	115 (42.6)	87 (32.2)	48 (17.8)	5 (1.9)	2.68±.894
Get around abilities	14 (5.2)	66 (24.4)	50 (18.5)	99 (36.7)	41 (15.2)	3.32±1.152
Sleep satisfaction	11 (4.1)	90 (33.3)	36 (13.3)	105 (38.9)	28 (10.4)	3.18±1.128
Daily activities	2(.7)	45 (16.7)	91 (33.7)	126 (46.7)	6 (2.2)	3.33±.803
Work Capacity	8 (3.0)	158 (58.5)	61 (22.6)	42 (15.6)	1 (.4)	2.52±.803
Psychological domain
Enjoying life	10 (3.7)	37 (13.7)	103 (38.1)	116 (43.0)	4 (1.5)	3.25±.846
Meaningful life	6 (2.2)	11 (4.1)	103 (38.1)	146 (54.1)	4 (1.5)	3.49±.704
Ability to concentrate	11 (4.1)	88 (32.6)	43 (15.9)	119 (44.1)	9 (3.3)	3.10±.1.028
Body appearance	6 (2.2)	10 (3.7)	127 (47.0)	112 (41.5)	15 (5.6)	3.44±.753
Self-satisfaction	0 (0.0)	28 (10.4)	87 (32.2)	151 (55.9)	4 (1.5)	3.49±.699
Negative Feelings	39 (14.4)	72 (26.7)	75 (27.8)	73 (27.0)	11 (4.1)	2.80±.1.114
Social Relationship Domain
Relationship satisfaction	0 (0.0)	10 (3.7)	35(13.0)	215 (79.6)	10 (3.7)	3.83±.537
Sexual satisfaction	11 (4.1)	61 (22.6)	127 (47.0)	68 (25.2)	3 (1.1)	2.97±.829
Social support	0 (0.0)	9 (3.3)	40 (14.8)	190 (70.4)	31 (11.5)	3.9±.623
Environmental Domain
Life Safety	7 (2.6)	66 (24.4)	86 (31.9)	109 (40.4)	2 (.7)	3.12±.877
Healthy environment	1 (.4)	1 (.4)	50 (18.5)	186 (68.9)	32 (11.9)	3.91±.588
Financial Satisfaction	19 (7.0)	115 (42.6)	64 (23.7)	55 (20.4)	17 (6.3)	2.76±1.054
Informational sources	19 (7.0)	91 (33.7)	60 (22.2)	84 (31.1)	16 (5.9)	2.95±1.081
Leisure activities	13 (4.8)	145 (53.7)	68 (25.2)	43 (15.9)	1 (.4)	2.53±.83
Living Place	1 (.4)	7 (2.6)	55 (20.4)	192 (71.1)	15 (15.6)	3.79±.594
Healthcare satisfaction	6 (2.2)	90 (33.3)	60 (22.2)	102 (37.8)	12 (4.4)	3.09±.987
Transport Satisfaction	14 (5.2)	65 (24.1)	51 (18.9)	99 (36.7)	41 (15.2)	3.33±1.149

Table 6 shows that minimum and maximum scores for a physical, psychological, social relationship, and environmental domains are 7.14, 4.17, 16.67, 18.75, and 82.14, 91.67, 100, and 87.5 respectively. The mean highest and lowest scores were found in the social relationship domain (64.17±11.5) and physical domain (47.08±14.39) while mean scores for the psychological domain and environmental domain were 56.5±14.35 and 54.65±12.25 respectively. Similarly, the mean score for overall quality of life was 55.60±10.25.

Table 6. Health-related quality of life of warfarin using clients.

					n=270
Domains	Transferred score			95% CI*
Minimum		Maximum	Mean±SD	Lower	Upper
Physical	7.14	82.14	47.08±14.39	45.43	48.47
Psychological	4.17	91.67	56.50±14.35	54.55	58.14
Social	16.67	100	64.17±11.50	62.74	65.41
Environmental	18.75	87.5	54.65±12.25	53.20	56.16
Overall QoL	28.94	84.23	55.60±10.25	54.33	56.92

* CI-Confidence Interval.

Table 7 depicts that the higher percentage of warfarin users (64.8%) had a moderate level of quality of life whereas 16.3 percent clients had low quality of life and 18.9 percent had a relatively high level of quality of life.

Table 7. Level of health-related quality of life of warfarin using clients.

			n=270
Level of quality of life	No. (%)	95% Confidence Interval
Level of quality of life	No. (%)	Lower	Upper
Low (≤45)	44(16.3)	12.1	20.4
Moderate (45–65)	175(64.8)	59.2	70.8
Relatively High (>65)	51(18.9)	13.7	23.4

Table 8 depicts the highly significant association of health-related quality of life of warfarin user with their residence, education, and socioeconomic class (p≤.001). Likewise, a significant association was found between age (p=.015) and sex (p≤.007) of warfarin-using clients with their health-related quality of life.

Table 8. Association between level of quality of life of warfarin using clients and socio-demographic characteristics.

					n=270
Characteristics Age	Level of Quality of life			χ²	p-value
Characteristics Age	Low No. (%)	Moderate No. (%)	Relatively high No. (%)	χ²	p-value
18-45 Years	21 (13.6)	95 (61.7)	38 (24.7)
46-78 Years	23 (19.8)
Sex	80 (69.0)	13 (11.2)	8.451	.015
Male	11 (9.8)	72 (64.3)	29 (25.9)
Female	33 (20.9)
Marital status	103 (65.2)	22 (13.9)	9.903	.007
Married	35 (15)	153 (67.5)	45 (19.3)
Unmarried	9 (24.3)
Residence of clients	22 (59.5)	6 (16.2)	2.048	.359
Urban	20 (12.8)	94 (60.3)	42 (26.9)
Rural	24 (21.1)	81 (71.1)	9 (7.9)	16.549	<.001
Socioeconomic class
Middle	8 (7.3)	64 (58.7)	37 (33.9)
Lower	36 (22.4)	111 (68.9)	14 (8.7)	31.985	<.001

Table 9 elucidates the statistically significant association of comorbidities (p=.008) with health-related quality of life while non-significant results were observed in the case of indication, duration, side effects, daily dose of warfarin, and latest INR level.

Table 9. Association between level of quality of life and warfarin-related variables.

					n=270
Variables	Level of Quality of life			χ²	p-value
Variables	Low No. (%)	Moderate No. (%)	Relatively high No. (%)	χ²	p-value
Indication of Medicine Use
VR	29 (16.1)	117 (64.6)	35 (19.3)
NVR	15 (16.8)	58 (65.2)	.086	.958
16 (17.0)
Duration of warfarin use
<1 Year	16 (20.3)	50 (63.3)	13 (16.4)
1-5 Year	10 (13.7)	53 (72.6)	10 (13.7)	4.866	.301
>5 Year	18 (15.3)	72 (61.0)	28 (23.7)
Side effect of Medicine
No	33 (14.7)	146 (65.2)	45 (20.1)
Yes	11 (23.9)	29 (63.1)	3.004	.223
6 (13.0)
Comorbidities
No	27 (12.8)	140 (66.4)	44 (20.8)
Yes	17 (28.8)	35 (59.3)	9.582	.008
7 (11.9)
Daily dose of Warfarin
<5mg/day	20 (15.6)	85 (66.4)	23 (18)
5-7.5mg/day	20 (16.3)	81 (65.9)	22 (17.8)	3.005	.557
>7.5mg/day	4 (21.1)	9 (47.4)	6 (31.5)
INR Level
Deranged (<2 and>3.5)	24 (17.5)	92 (67.2)	21 (15.3)	2.365	.308
Ranged (2-3.5)	20 (15.0)	83 (62.4)	30 (22.6)

Table 10 presents statistically significant positive correlations observed between each domain of quality of life, perceived quality of life, and health satisfaction rated by warfarin using clients as well as overall calculated quality of life. A positive strong correlation was found between the overall quality of life and physical domain (r=.768, p≤.001), psychological domain (r=.794, p≤.001), environmental domain (r=.777, p≤.001), and moderate correlation with social relation domain (r=.545, p≤.001).

Table 10. Relationship among perceived QoL, perceived health satisfaction, four domains, and overall QoL of warfarin using clients.

		Perceived QoL	Perceived health satisfaction	Physical domain	Psychological domain	Social domain	Environmental domain	Overall QoL
Perceived QoL	Correlation (r)	1
	Sig. (2-tailed)
Perceived Health satisfaction	Correlation (r)	.574^**	1
Perceived Health satisfaction	Sig. (2-tailed)	<.001
Physical domain	Correlation (r)	.321^**	.440^**	1
	Sig. (2-tailed)	<.001	<.001
Psychological domain	Correlation (r)	.438^**	.484^**	.605^**	1
Psychological domain	Sig. (2-tailed)	<.001	<.001	<.001
Social Domain	Correlation (r)	.203^**	.295^**	.277^**	.400^**	1
	Sig. (2-tailed)	<.001	<.001	<.001	<.001
Environmental domain	Correlation (r)	.457^**	.435^**	.612^**	.619^**	.372^**	1
Environmental domain	Sig. (2-tailed)	<.001	<.001	<.001	<.001	<.001
Overall QoL	Correlation (r)	.419^**	.505^**	.768^**	.794^**	.545^**	.777^**	1
	Sig. (2-tailed)	<.001	<.001	<.001	<.001	<.001	<.001

** Correlation is significant at the 0.01 level (2-tailed), r- Spearman's rank correlation.

Discussion

Health-related quality of life among warfarin-using clients

The findings of the present study resulted in a mean score (55.60±10.25) for overall quality of life among warfarin-using clients. More than half (64.8%) of the clients had a moderate level of quality of life (45-65). Likewise, 18.9% had a relatively high quality of life (>65) and 16.3% had a low quality of life ((δ45). A relatively high quality of life (65.00±16.00) was observed in a study conducted in France⁸ among long-term vitamin K antagonist users. Similarly, a study conducted in Malaysia regarding health-related quality of life among atrial fibrillation patients using warfarin therapy resulted relatively high mean score (69.3±16.3) for overall quality of life.⁹ Another Malaysian study also showed a relatively high mean score (68.7±11.30) on overall quality of life in warfarin users.¹⁰

The present study evaluates the HRQoL of warfarin using clients based on mean scores obtained from each domain of WHOQoL-BREF. In this study, the highest mean score is found for the social relationship domain (64.17±11.5). The study conducted by Almeida et al. in Brazil also resulted in the highest mean score (80.4±23.8) for the same domain.¹¹ The mean score for the social relationship domain was found similar to the present study in the study conducted in Pakistan (64.27±26.28), Malaysia (63.35±27.06), and Saudi Arabia (64.46±26.19).¹²^–¹⁴ However, contradictory findings (mean score 49.0±10.7) were obtained from the study conducted in Malaysia for the same domain.¹⁰ The highest mean score for the social relationship domain in our setting might be due to better personal relationships and satisfactory support from family and friends.

Likewise, the mean score for the physical domain is found lowest (47.08±14.39) among all four domains of WHOQoL-BREF in this study which is consistent with the findings of the alike studies conducted in Malaysia (61.14±15.96), Pakistan (62.44±15.36), and Saudi Arabia (62.11±15.53).¹²^–¹⁴ In addition, the lowest mean score (44.0±9.6) for physical health was also found in a study conducted in Italy,¹⁵ and two different studies in Malaysia (47.0±9 and 45.0±10.2.¹⁰^,¹⁶ In contrast, the highest mean score for their study in physical health (47.00±4.00) was found in the study conducted in Turkey.¹⁷ Experience of extreme physical pain, presence of comorbidities, poor sleep pattern, and compromised work capacity may have adversely affected the physical quality of life of warfarin-using clients.

Regarding the psychological domain in this study, the domain score ranges from 4.17 to 91.67 with moderate mean±SD (56.5±14.35) which is consistent with the findings (mean±sd 52.7±8.5 and 53.5±9.6) of the studies conducted in Malaysia for the same domain.¹⁰^,¹⁶ Relatively higher mean scores (68.58±16.11, 67.84±15.54, 68.20±16.11, and 65.33±17.50) for the psychological domain were found in the studies conducted in Malaysia, Pakistan, Saudi Arabia, and Turkey, which is also the highest mean score among four domains of their studies.¹²^–¹⁴^,¹⁸

Similarly, a moderate mean score (54.65±12.25) for the environmental domain is found in the present study with scores ranging from 18.75 to 87.50, which is consistent with the mean score for the environmental domain in the studies conducted in Malaysia (62.78±17.58), Pakistan (63.45±17.66) and Saudi Arabia (63.43±17.60).⁷^,¹³^,¹⁴ Comparatively lower mean score for the environmental domain in the Nepalese context might be due to lower socioeconomic status, lack of information regarding therapy, poor recreational habits, and limited accessibility to health services, and transportation facilities.

Association between HRQoL of warfarin users and selected variables

This study resulted in a significant association between overall age (p=.015), sex (p=.007), place of residence (p≤.001), and socioeconomic class (p≤.001) with health-related quality of life of warfarin users. Relatively high quality of life was observed in the 24.7 percent younger group whereas a statistically significant association was observed in physical (p≤.001) and psychological domains (p=.002). This finding varies with the study conducted in Malaysia where a non-significant (p=.76) association was found with age.¹³ Likewise, the findings of this study showed that male warfarin-using clients had better scores in all domains of QoL which is in contrast (p=.146) to the findings of a similar study conducted in Pakistan.¹² This might be due to better control of males in household income and decision-making power in our context. Regarding the place of residence, urban clients had a significantly better quality of life in all domains except the social relationship domain (p=.159). Similarly, a higher mean score was found in the middle socioeconomic class (60.30±9.74 versus 52.41±9.34) in comparison to the lower socioeconomic class with overall quality of life.

Furthermore, a statistically significant association (p=.008) between quality of life and the presence of comorbidities was observed in the present study having better quality of life in clients with no comorbidities than those having various comorbidities in all domains except the environmental domain (p=.712). However, the study conducted by Iqbal et al. in Pakistan resulted in better and statistically significant findings in all four domains of QoL with p-value ranges from <.001 to.002.¹² Comparatively better (56.88±10.16 versus 54.35±10.22) but statistically non-significant association (p=.308) was observed in those with controlled INR levels which is consistent with the findings of the study conducted in Spain (4.9±1.0 versus 3.6±1.3).¹⁹

Relationship among health-related quality of life and domain scores

The findings of the present study resulted in a moderate positive correlation between overall quality of life with perceived quality of life (r=.419, p≤.001) and health satisfaction (r=.505, p<.001). Similarly, strong positive correlation between overall quality of life and psychological (r=.794, p≤.001), environmental (r=.777, p≤.001), physical domain (r=.768, p≤.001), and moderate positive correlation with social relationship domain (r=.545, p≤.001) was observed in this study. This finding was supported by the study conducted in Pakistan which showed a positive relationship (correlation coefficient values range from 0.242 to 0.627, p≤.001) between each domain of QoL with overall QoL.¹²

Conclusion

Based on the findings of this study, it concludes that the highest mean score is obtained in the social relationship domain, while the lowest mean score is observed in the physical health domain. The overall health-related quality of life of clients using warfarin therapy is moderate. Further, the quality of life of the clients using warfarin therapy tends to vary with their age, sex, place of residence, socioeconomic class, and comorbidities present in them. Similarly, physical health, psychological, and environmental domains have considerably strong positive associations with overall quality of life. Likewise, a moderate positive relationship is found between actual quality of life and perceived quality of life and health satisfaction.

Limitation

In this study exploration of subjective information might have been limited due to structured questionnaires. The generalizability of the findings might be limited due to a cross-sectional purposively selected single-setting sample. Respondents’ response bias might have influenced the overall result of the study.

Implication

The findings of the current study could help to inform healthcare professionals about the problems faced by warfarin-using clients and focus more on making their better quality of life while prescribing and providing holistic care throughout therapy. Findings might be supportive to concerned authorities to strengthen themselves for improving the quality of life of clients. This study also might serve as a baseline reference for concluding further studies on a similar subject.

Recommendation

Institutional authorities should conduct awareness programs for healthcare professionals and family members regarding the physical, psychological, social, and environmental health of warfarin using clients to improve their quality of life from time to time.

More emphasis should be given by the concerned authority while taking care of and counseling patients above 45 years, females, rural residents, those of lower socioeconomic class, and those who have comorbidities.

Further qualitative and multiple-setting research should be done for more generalizability.

Ethics and consent

The approval of the research proposal was obtained from the Research Committee of Pokhara Nursing Campus, Tribhuvan University (TU), and ethical clearance from the Institutional Review Committee (IRC) of Tribhuvan University, Kathmandu on feb 2, 2021 ref no. 261/(6-11) E2/077/078 The formal permission was taken from Man Mohan Cardiothoracic Vascular and Transplant Centre (MCTVC) for data collection through a request letter from Pokhara Nursing Campus.

Clients using warfarin medicine for at least two months, age ≥ 18 years, able to consent both written and verbal were included in this study.

The consent was both verbal and written. The participants were initially informed about the nature of the research verbally and then a written consent form was filled out and asked to sign by them if interested.

Data availability

Underlying data

Figshare: Health-Related Quality of Life Among Warfarin Using Clients in a Cardiac Centre: A Cross-sectional Descriptive Study:

Data SPSS https://doi.org/10.6084/m9.figshare.24958602 ²⁰

This project contains the following underlying data:

• Data SPSS (raw data for the 270 individuals included in the final analysis)

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

Extended data

Figshare: Questionnaire

https://doi.org/10.6084/m9.figshare.24972114 ²¹

The project contains tools used for data collection.

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

Reporting guidelines

Figshare: STROBE checklist for ‘Impact of Clinical Factors on Hospital Stay and Hospital Readmission Rate After Acute Exacerbation Of COPD: A Retrospective Cross-Sectional Study.

STROBE checklist

https://doi.org/10.6084/m9.figshare.24987990 ²²

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

regarding quality of life and other aspects of clients using warfarin therapy.

References

1. Nepal R, Bista M, Dhungana SP: Patterns of rheumatic heart disease and treatment practices at tertiary care center in nepal: A descriptive cross-sectional study. J. Nepal Med. Assoc. 2020; 58(230): 784–788. Publisher Full Text
2. Koirala B: Surgery for Rheumatic Heart Disease in Nepal. Nepal. Heart J. 2016 Aug 27 [cited 2024 Jan 9]; 13(2): 11–14. Publisher Full Text Reference Source
3. Asian Journal of Biomedical and Pharmaceutical Sciences.[cited 2024 Jan 9]. Reference Source
4. Wen MS, Ta M, Lee M, et al.: Warfarin Pharmacogenetics: New Life for an Old Drug. Acta Cardiol. Sin. 2013 May [cited 2024 Jan 9]; 29(3): 235. Free Full Text
5. Iqbal MS, Kassab YW, Al-Saikhan FI, et al.: Assessing quality of life using WHOQOL-BREF: A cross-sectional insight among patients on warfarin in Malaysia. Saudi Pharm. J. 2020 Aug 1; 28(8): 936–942. Publisher Full Text
6. Cochran WG: Sampling Techniques. Wiley; 3rd Ed.1977. (047116240x)|PDF. [cited 2024 Jan 9]. Reference Source
7. Iqbal MS, Muthanna FMS, Kassab YW, et al.: Determinants of health-related quality of life among warfarin patients in Pakistan. PLoS One. 2020 Jun 1 [cited 2024 Jan 9]; 15(6): e0234734. Publisher Full Text
8. Benzimra M, Bonnamour B, Duracinsky M, et al.: Real-life experience of quality of life, treatment satisfaction, and adherence in patients receiving oral anticoagulants for atrial fibrillation. Patient Prefer. Adherence. 2018 Jan 4 [cited 2024 Jan 10]; 12: 79–87. Publisher Full Text Reference Source
9. Radaideh KM, Matalqah LM: Health-Related Quality of Life among Atrial fibrillation Patients Undergoing Anticoagulation Therapy. Epidemiol. Biostat. Public Health. 2018 [cited 2024 Jan 10]; 15(1): e12763-1–e12763-8. Publisher Full Text Reference Source
10. Ng DLC, Malik NMBA, Chai CS, et al.: Time in therapeutic range, quality of life and treatment satisfaction of patients on long-term warfarin for non-valvular atrial fibrillation: a cross-sectional study. Health Qual. Life Outcomes. 2020 Dec 1 [cited 2024 Jan 10]; 18(1): 1–9. Publisher Full Text
11. Almeida GDQ, Noblat L d A, Passos LCS, et al.: Quality of Life analysis of patients in chronic use of oral anticoagulant: An observational study. Health Qual. Life Outcomes. 2011 Oct 25 [cited 2024 Jan 12]; 9(1): 91–96. Publisher Full Text
12. Iqbal MS, Muthanna FMS, Kassab YW, et al.: Determinants of health-related quality of life among warfarin patients in Pakistan. PLoS One. 2020 Jun 1 [cited 2024 Jan 10]; 15(6): e0234734. Publisher Full Text
13. Iqbal MS, Kassab YW, Al-Saikhan FI, et al.: Assessing quality of life using WHOQOL-BREF: A cross-sectional insight among patients on warfarin in Malaysia. Saudi Pharm. J. 2020 Aug 1; 28(8): 936–942. Publisher Full Text
14. Al-Saikhan F: Warfarin therapy adherence and health-related quality of life among patients using warfarin in Saudi Arabia. Niger. J. Clin. Pract. 2020 Mar 1 [cited 2024 Jan 10]; 23(3): 398–407. Publisher Full Text Reference Source
15. Magon A, Arrigoni C, Moia M, et al.: Determinants of health-related quality of life: A cross-sectional investigation in physician-managed anticoagulated patients using Vitamin K antagonists. Health Qual. Life Outcomes. 2020 Mar 16 [cited 2024 Jan 10]; 18(1): 1–9. Publisher Full Text
16. Leh-Ching Ng D, Gan GG, Chai CS, et al.: Comparing quality of life and treatment satisfaction between patients on warfarin and direct oral anticoagulants: a cross-sectional study. Patient Prefer. Adherence. 2019 Aug 14 [cited 2024 Jan 10]; 13: 1363–1373. Publisher Full Text Reference Source
17. Aktas H, Inci S, Dogan P, et al.: Spontaneous rectus sheath hematoma in a patient treated with apixaban. Intractable Rare Dis. Res. 2016; 5(1): 47–49. Publisher Full Text
18. Çoban E, Ataklı D, Soysal A, et al.: Quality of Life of Patients Under Anticoagulant Therapy Compared to Patients Treated with Antiplatelet Therapy. Arch. Neuropsychiatry. 2018 [cited 2024 Jan 12]; 55(2): 157. Free Full Text
19. Varona JF, Seguí-Ripoll JM, Lozano-Duran C, et al.: Health-related quality of life in nonvalvular atrial fibrillation patients with controlled or uncontrolled anticoagulation status. Health Qual. Life Outcomes. 2020 Dec 1 [cited 2024 Jan 10]; 18(1): 1–10. Publisher Full Text
20. Untitled Item: [cited 2024 Jan 12]. Publisher Full Text Reference Source
21. Chaurasiya P: Untitled Item.2024 Jan 10 [cited 2024 Jan 12]. Publisher Full Text
22. STROBE-checklist-v4-cross-sectional Health-Related Quality of Life Among Warfarin Using Clients in a Cardiac Centre.[cited 2024 Jan 12]. Publisher Full Text Reference Source

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VERSION 1 PUBLISHED 24 Jun 2024

Author details Author details

¹ Internal Medicine, Civil Service Hospital, Kathmandu, Bagmati, Nepal
² Internal Medicine, Institute of medicine, Tribhuwan University, Kathmandu, Bagmati, Nepal
³ Tribhuvan University, Institute of Medicine, Pokhara Nursing Campus, Pokhara,, Pokhara, Nepal
⁴ Internal Medicine, National Medical College, Birgunj, Madhesh, Nepal
⁵ Internal Medicine, Kalaiya Hospital, Kalaiya, Madhesh, Nepal

Sapana Pokhrel
Roles: Funding Acquisition, Investigation, Methodology

Mandira Onta
Roles: Project Administration, Resources, Software

Ranjita Karmacharya
Roles: Supervision, Validation, Writing – Review & Editing

Avilasha Bhagat
Roles: Visualization, Writing – Original Draft Preparation

Prem Shankar Chaurasiya
Roles: Conceptualization, Data Curation, Formal Analysis

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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https://doi.org/10.12688/f1000research.147174.1

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Pokhrel S, Onta M, Karmacharya R et al. Health-Related Quality of Life Among Warfarin Using Clients in a Cardiac Centre: A Cross-sectional Descriptive Study [version 1; peer review: awaiting peer review]. F1000Research 2024, 13:681 (https://doi.org/10.12688/f1000research.147174.1)

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[1] 1. Nepal R, Bista M, Dhungana SP: Patterns of rheumatic heart disease and treatment practices at tertiary care center in nepal: A descriptive cross-sectional study. J. Nepal Med. Assoc. 2020; 58(230): 784–788. Publisher Full Text

[2] 2. Koirala B: Surgery for Rheumatic Heart Disease in Nepal. Nepal. Heart J. 2016 Aug 27 [cited 2024 Jan 9]; 13(2): 11–14. Publisher Full Text Reference Source

[3] 3. Asian Journal of Biomedical and Pharmaceutical Sciences.[cited 2024 Jan 9]. Reference Source

[4] 4. Wen MS, Ta M, Lee M, et al.: Warfarin Pharmacogenetics: New Life for an Old Drug. Acta Cardiol. Sin. 2013 May [cited 2024 Jan 9]; 29(3): 235. Free Full Text

[5] 5. Iqbal MS, Kassab YW, Al-Saikhan FI, et al.: Assessing quality of life using WHOQOL-BREF: A cross-sectional insight among patients on warfarin in Malaysia. Saudi Pharm. J. 2020 Aug 1; 28(8): 936–942. Publisher Full Text

[6] 6. Cochran WG: Sampling Techniques. Wiley; 3rd Ed.1977. (047116240x)|PDF. [cited 2024 Jan 9]. Reference Source

[7] 7. Iqbal MS, Muthanna FMS, Kassab YW, et al.: Determinants of health-related quality of life among warfarin patients in Pakistan. PLoS One. 2020 Jun 1 [cited 2024 Jan 9]; 15(6): e0234734. Publisher Full Text

[8] 8. Benzimra M, Bonnamour B, Duracinsky M, et al.: Real-life experience of quality of life, treatment satisfaction, and adherence in patients receiving oral anticoagulants for atrial fibrillation. Patient Prefer. Adherence. 2018 Jan 4 [cited 2024 Jan 10]; 12: 79–87. Publisher Full Text Reference Source

[9] 9. Radaideh KM, Matalqah LM: Health-Related Quality of Life among Atrial fibrillation Patients Undergoing Anticoagulation Therapy. Epidemiol. Biostat. Public Health. 2018 [cited 2024 Jan 10]; 15(1): e12763-1–e12763-8. Publisher Full Text Reference Source

[10] 10. Ng DLC, Malik NMBA, Chai CS, et al.: Time in therapeutic range, quality of life and treatment satisfaction of patients on long-term warfarin for non-valvular atrial fibrillation: a cross-sectional study. Health Qual. Life Outcomes. 2020 Dec 1 [cited 2024 Jan 10]; 18(1): 1–9. Publisher Full Text

[11] 11. Almeida GDQ, Noblat L d A, Passos LCS, et al.: Quality of Life analysis of patients in chronic use of oral anticoagulant: An observational study. Health Qual. Life Outcomes. 2011 Oct 25 [cited 2024 Jan 12]; 9(1): 91–96. Publisher Full Text

[12] 12. Iqbal MS, Muthanna FMS, Kassab YW, et al.: Determinants of health-related quality of life among warfarin patients in Pakistan. PLoS One. 2020 Jun 1 [cited 2024 Jan 10]; 15(6): e0234734. Publisher Full Text

[13] 13. Iqbal MS, Kassab YW, Al-Saikhan FI, et al.: Assessing quality of life using WHOQOL-BREF: A cross-sectional insight among patients on warfarin in Malaysia. Saudi Pharm. J. 2020 Aug 1; 28(8): 936–942. Publisher Full Text

[14] 14. Al-Saikhan F: Warfarin therapy adherence and health-related quality of life among patients using warfarin in Saudi Arabia. Niger. J. Clin. Pract. 2020 Mar 1 [cited 2024 Jan 10]; 23(3): 398–407. Publisher Full Text Reference Source

[15] 15. Magon A, Arrigoni C, Moia M, et al.: Determinants of health-related quality of life: A cross-sectional investigation in physician-managed anticoagulated patients using Vitamin K antagonists. Health Qual. Life Outcomes. 2020 Mar 16 [cited 2024 Jan 10]; 18(1): 1–9. Publisher Full Text

[16] 16. Leh-Ching Ng D, Gan GG, Chai CS, et al.: Comparing quality of life and treatment satisfaction between patients on warfarin and direct oral anticoagulants: a cross-sectional study. Patient Prefer. Adherence. 2019 Aug 14 [cited 2024 Jan 10]; 13: 1363–1373. Publisher Full Text Reference Source

[17] 17. Aktas H, Inci S, Dogan P, et al.: Spontaneous rectus sheath hematoma in a patient treated with apixaban. Intractable Rare Dis. Res. 2016; 5(1): 47–49. Publisher Full Text

[18] 18. Çoban E, Ataklı D, Soysal A, et al.: Quality of Life of Patients Under Anticoagulant Therapy Compared to Patients Treated with Antiplatelet Therapy. Arch. Neuropsychiatry. 2018 [cited 2024 Jan 12]; 55(2): 157. Free Full Text

[19] 19. Varona JF, Seguí-Ripoll JM, Lozano-Duran C, et al.: Health-related quality of life in nonvalvular atrial fibrillation patients with controlled or uncontrolled anticoagulation status. Health Qual. Life Outcomes. 2020 Dec 1 [cited 2024 Jan 10]; 18(1): 1–10. Publisher Full Text

[20] 20. Untitled Item: [cited 2024 Jan 12]. Publisher Full Text Reference Source

[21] 21. Chaurasiya P: Untitled Item.2024 Jan 10 [cited 2024 Jan 12]. Publisher Full Text

[22] 22. STROBE-checklist-v4-cross-sectional Health-Related Quality of Life Among Warfarin Using Clients in a Cardiac Centre.[cited 2024 Jan 12]. Publisher Full Text Reference Source

Health-Related Quality of Life Among Warfarin Using Clients in a Cardiac Centre: A Cross-sectional Descriptive Study

Abstract

Background

Methods

Results

Conclusions

Keywords

Introduction

Methods

Research design and setting

Study population

Sampling technique

Inclusion criteria

Ethical consideration

Sample size calculation

Research instrumentation

Research method proper

Statistical analysis

Results

Table 1. Socio-demographic characteristics of warfarin using clients.

Table 2. Educational and socio-economic status of warfarin using clients.

Table 3. Information on the use of warfarin among warfarin using clients.

Table 4. Comorbidities, daily dose and latest INR level of warfarin using clients.

Table 5. Warfarin user's responses on WHOQoL-BREF items.

Table 6. Health-related quality of life of warfarin using clients.

Table 7. Level of health-related quality of life of warfarin using clients.

Table 8. Association between level of quality of life of warfarin using clients and socio-demographic characteristics.

Table 9. Association between level of quality of life and warfarin-related variables.

Table 10. Relationship among perceived QoL, perceived health satisfaction, four domains, and overall QoL of warfarin using clients.

Discussion

Health-related quality of life among warfarin-using clients

Association between HRQoL of warfarin users and selected variables

Relationship among health-related quality of life and domain scores

Conclusion

Limitation

Implication

Recommendation

Data availability

Underlying data

Extended data

Reporting guidelines

References

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