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 Table of Contents  
ORIGINAL ARTICLE
Year : 2016  |  Volume : 7  |  Issue : 1  |  Page : 10-16

Compliance with and awareness about long-term oral anticoagulant therapy among Saudi patients in a University Hospital, Riyadh, Saudi Arabia


1 Department of Center of Excellence in Thrombosis and Hemostasis, College of Medicine, Center of Excellence in Thrombosis and Hemostasis, King Saud University, Riyadh, Saudi Arabia
2 Department of Physiology, College of Medicine, Center of Excellence in Thrombosis and Hemostasis, King Saud University, Riyadh, Saudi Arabia

Date of Web Publication25-Apr-2016

Correspondence Address:
Nervana M. K Bayoumy
Department of Physiology, College of Medicine, Center of Excellence in Thrombosis and Hemostasis, King Saud University, P.O. Box 2925, Riyadh 11461
Saudi Arabia
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/1658-5127.181107

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  Abstract 

Context: Oral anticoagulant therapy (OAT) is one of the most widely used therapies. Being on such regimens requires high degree of compliance and adequate knowledge to avoid serious complications. Aims: This study aims to assess compliance with and awareness about OAT among Saudi patients, and their willingness to use the point-of-care (POC) international normalized ratio (INR) testing devices for self-monitoring. Settings and Design: This cross-sectional study was conducted at a tertiary hospital in Riyadh, Saudi Arabia, over 6 months. Subjects and Methods: A face-to-face interview has been carried out for all patients based on the questionnaire carried out for all patients based on the questionnaire. Results were analyzed according to demographics, adherence, knowledge, and INR control. Statistical Analysis Used: Statistical Package for the Social Sciences version 19 software (SPSS Inc., Chicago, IL, USA) was used. Results: One hundred sixty-two patients were interviewed, of which females (69.1%) exceeded males (30.1%). Most of them were on warfarin (80.2%), received education by their physicians. In general, patients had poor knowledge and medium adherence (53.1%) (scored < 50%). About 24% of the poor knowledge group (PKG) were highly adherent compared to 14.5% of the fine knowledge group (FKG). However, 53.2% of FKG had a controlled INR where this percentage reduces to 27% in PKG. The most incorrect answered question in both groups was related to warfarin-drug-interactions (75.3%). The majority (74.7%) was eager to make use of the POC-INR devices. Conclusions: The participants' knowledge was generally poor but level of knowledge did not play a role in compliance. Regardless, an education program should be accommodated to help patients in improving their medication control and reducing clinical visits. The majority was willing to adopt (POC) INR devices that will certainly help them in managing their treatment and potentially reducing adverse clinical outcomes.

Keywords: Compliance, knowledge, oral anticoagulant, therapy


How to cite this article:
Al-Omair SF, Musallam NA, Al-Deghaither NY, Al-Sadoun NA, Bayoumy NM. Compliance with and awareness about long-term oral anticoagulant therapy among Saudi patients in a University Hospital, Riyadh, Saudi Arabia. J Appl Hematol 2016;7:10-6

How to cite this URL:
Al-Omair SF, Musallam NA, Al-Deghaither NY, Al-Sadoun NA, Bayoumy NM. Compliance with and awareness about long-term oral anticoagulant therapy among Saudi patients in a University Hospital, Riyadh, Saudi Arabia. J Appl Hematol [serial online] 2016 [cited 2018 May 23];7:10-6. Available from: http://www.jahjournal.org/text.asp?2016/7/1/10/181107


  Introduction Top


Oral anticoagulant therapy (OAT) is used in treating various thromboembolic events.[1] Warfarin is commonly used but it has a narrow therapeutic window.[2] The international normalized ratio (INR) is used to maintain patients on OAT in the therapeutic range which varies mainly between 2.0 and 3.0.[3],[4] An alternative method is the INR point-of-care testing (POCT) devices, which reveal results rapidly.[5] This study assesses the compliance and knowledge of Saudi patients on OAT since it has not been done locally. INR needs to be measured regularly; many patients are inconvenienced by the repeated hospital visits. POC devices have been introduced to tackle such issues.


  Subjects and Methods Top


This cross-sectional study was conducted in the anticoagulation clinic at King Khalid University Hospital (KKUH) in Riyadh during the period November 2013–April 2014. KKUH is one of the biggest well-known tertiary hospitals and has been functioning since 1982. The anticoagulation clinic is an active clinic receiving about sixty patients in each operating day to monitor and manage their treatment. It operates half a day on Sunday, Tuesday, and Thursday. A sample of 378 patients on OAC therapy was established in the period between November 2013 and April 2014. All patients from both genders and all ages had to be on OAT for more than 6 months attending the anticoagulation clinic in KKUH, Riyadh, Saudi Arabia, to be included in the study. Patients on OAC < 6 months and patients with cognitive impairment attending the clinic without a companion were excluded from the study. A face-to-face interview questionnaire consisting of four parts was carried out. The first part of the questionnaire consisted of demographics and the anticoagulation treatment regimen (name of the oral drug, information provider, indication and duration of treatment, previous hospitalization because of the treatment, OAC complication, and concurrent medications). In the second part, the Morisky 8-item medication adherence scale [6] was used to assess patients' compliance. The third part of the questionnaire consisted of ten questions to assess patients' knowledge about OAT, the questions were derived from the oral anticoagulation knowledge test (OAK) developed by Zeolla et al.[7] It covered the main topics on warfarin such as medication safety, diet and Vitamin K interactions, complication of OAC when taken with nonsteroidal anti-inflammatory drugs, the INR test, goal range of INR, effect of missing one dose and its management, when the patient should seek immediate medical attention, besides the importance of monitoring any signs of bleeding. The last part aimed to assess the INR control, which included five questions on the patient's last two INR readings, their therapeutic INR range, check-up frequency, presence of any companion during visits, and the last question was to assess the patients' willingness to use INR POC devices and what are the factors formulating their opinions. The questionnaire was translated into an Arabic version correspondently with the study's population. Both English and Arabic versions were analyzed and approved by an English/Arabic high school teacher. Only the 162 patients who completed the questionnaires were interviewed and included in the analysis. In this study, the following criteria were applied.

Compliance

The patient has high, medium, or low adherence based on the Morisky 8-item medication adherence scale [6] (0 = high adherence, 1 or 2 = medium adherence, and >2= low adherence).

Knowledge

Participants were divided into two groups based on their knowledge level: Satisfactory knowledge group, where they score 7 out of 10 (75%) correct answers in the OAK test [7] and unsatisfactory group, scoring below 7. However, this classification was not applicable because of the minor number (n = 19) in the satisfactory knowledge group, and it will be insignificant in analyzing the effect of knowledge on their INR control and the other related factors. Therefore, a new classification was done; fine knowledge about OAT (ine knowledge group [FKG]): Participants who scored at least (50%) (≥5 correct answers out of ten questions); poor knowledge about OAT (poor knowledge group [PKG]): Participants who scored below (50%) (<5 questions). “Do not know” option was provided, and it was scored as “false.”

International Normalized Ratio Control and International Normalized Ratio Point-of-Care Testing Devices

The INR readings on the last two visits for each patient were obtained to assess if it was within the therapeutic range. In addition to that, the patients were asked in the final part of the questionnaire if they were willing to use the INR POC testing devices and about the factors affecting their decision.

Data analysis was performed using Statistical Package for the Social Sciences (SPSS) version 19 software (SPSS Inc., Chicago, IL, USA) where nominal variables were expressed as frequencies and quantitative variables (age, scores) as mean ± standard deviation scoring about knowledge and adherence was carried out. Comparison between knowledge, adherence, and INR range with demographics was done using Chi-square test. All statistical tests were declared statistically significant at P ≤ 0.05.


  Results Top


One hundred sixty-two patients attending the anticoagulation clinic at KKUH were interviewed out of 387-estimated sample size. Females (69.1%) exceeded males (30.1%). The mean age was 52.09 ± 15.342. About 85.8% of the participants were from Riyadh, while only 14.2% of the respondents were living in different territories of the kingdom [Table 1].
Table 1: Descriptive data for demographic information (n=162)

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Descriptive Data About Anticoagulation Treatment

Most of the respondents (89.5%) were on Coumadin (Warfarin). Nearly 80.2% of the total respondents received education about the treatment mainly by their physicians, while 19.8% did not receive any education about OAT. Indications of OAT are shown in [Graph 1 [Additional file 1]], where 39.5% of the participants were taking the medication to treat different thromboembolic diseases.

Compliance with Oral Anticoagulant Therapy

Patients' compliance was assessed based on Morisky 8-item medication adherence scale (0 = high adherence, 1 or 2 = medium adherence, and >2= low adherence). The majority (53.1%) of patients had medium adherence, leaving 20.4% with high adherence, and 26.6% with low adherence.

On studying the relationship between patients' demographics and their compliance with their treatment, 45.15% of the highly adherent participants were from the old age group (60 years and above). However, this was statistically insignificant (P = 0.336). The results showed that 30% (n = 15) from the total males were highly adherent while only 16.1% (n = 18) of the total female participants were highly adherent. Compliance's association with gender was also statistically insignificant (P = 0.081). The correlation between compliance and the educational level was clinically insignificant although it was statistically significant (P = 0.032). As it was found that those who are illiterate and those who have low education were highly adherent with their treatment. However, only 27.3% (n = 9) of the highly adherent participants were highly educated [Table 2] and [Graph 2 [Additional file 2]].
Table 2: Association between demographic characteristics and adherence

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Patients' Knowledge About Oral Anticoagulant Therapy

Initially, participants were divided into two groups based on their knowledge level: Satisfactory knowledge group where they score 7 out of 10 (75%) correct answers in the OAK test and unsatisfactory group, scoring below 7. However, this classification was not applicable because of the limited number (n = 19) in the satisfactory knowledge group that will affect the analysis of knowledge on their INR control and other factors. Therefore, a new classification was done; FKG: Participants who scored at least 50% (≥5 correct answers out of ten questions). PKG: Participants who scored below 50% (<5 questions). Nearly 43.8% of the total females were in FKG while only 26% of the total males fall in this category (P = 0.032) [Graph 3 [Additional file 3]]. There was an insignificant difference between FKG and PKG regarding the participant's age (P = 0.271) [Table 3]. There was a slight difference between FKG and PKG regarding their level of education (P = 0.444). About 50% of FKG were highly educated while 40% were among PKG. Regarding the relationship between knowledge and compliance, high adherent participants were higher in PKG representing 24% than 14.5% of FKG (P = 0.205). However, a significant difference was discovered between the two groups regarding their INR control; 53.2% of FKG had a controlled INR where this percentage falls into 27% among PKG (P = 0.001). Based on the questions derived from the OAK test, we found that the most incorrect answered question in both groups was related to warfarin-drug-interactions while the most correct answered question was related to the INR-goal range [Table 4].
Table 3: Association between demographic characteristics and knowledge

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Table 4: Questions from the oral anticoagulation knowledge test

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International Normalized Ratio Point-of-Care Testing Devices

The final part of the questionnaire assessed patients' willingness to use the INR-POC test devices. The results showed that 74.7% (n = 121) were accepting to use the INR-POCT devices if they were available while 25.3% (n = 41) disapproved to consume them.


  Discussion Top


Being on oral anticoagulation regimens requires high degree of compliance and adequate knowledge to avoid serious complications that can result from the treatment. With increasing need for long-term adherence to treatment, a reliable and valid measure of patient adherence, which can be easily administered, is needed. This study reports the development and evaluation of a medication adherence scale that is easy to administer. The scale can be used as an initial tool to screen patients for low adherence, and at risk for uncontrolled INR, compared to patients with medium to high adherence. Adherence to oral anticoagulant treatment is influenced by many factors, some of which are modifiable. Adherence rates have been shown to be associated with age, gender, and education level. Several studies have shown demographic disparities between younger and older individuals regarding medication adherence.[8],[9] Other factors reported to negatively impact adherence to prescribed therapies include lack of knowledge regarding OAT, complexity of medication regime, health care system perceptions by the patients, side effects of medication, and poor quality of life. In our study, we identified several modifiable variables in the logistic regression model that predict medication adherence. Our study revealed that almost half of the patients (53.1%) have medium adherence to OAT and only 20% have high adherence based on Morisky 8-item medication adherence scale. High adherence was found in males more than females where the percentage of the highly adherent participants in males was 45% while in females, it was 16%. Our study revealed an unexpected result, it showed that 75% of patients with high adherence have an abnormal INR and 62% of patients with poor adherence have also an abnormal INR which indicates that the INR control was insignificantly associated with medication adherence (P = 0.204). Similarly, Esmerio et al. had also showed that there was no statistically significant difference between adherence and INR control.[10] In contrary to our results, there were some studies that found an association between compliance and INR control. Barcellona et al.[4] and Kimmel et al.[11] showed that compliance is an important factor in maintaining the INR; results revealed that the adherent patients have a better INR control than the nonadherent patients. The results showed an association between age and compliance as patients get older they become more adherent with their OAT. The majority of our compliant patients were 60 years old and above and that could be due to the long duration on oral anticoagulants that made them appreciate the importance of compliance and how complications may arise if they were not adherent. The study also revealed that there is no clinical correlation between INR control and education level. The participants' knowledge was generally poor where most of them (61.7%) were in the PKG, who scored less than 50% in the OAK test. Previous studies were in agreement with this finding.[12],[13],[14] On the other hand, only 38.3% were in the fair knowledge group. This classification was done to study the influence of the patients' knowledge about OAT on INR control and compliance, also to check if gender, age, and level of education have any relation to the patients' knowledge. Results showed a positive association between the patients' knowledge and the INR control. This was demonstrated when more than half of the participants (53.2%) with fair knowledge on OAT had their INR values within the therapeutic range. This result emphasizes the need for patient education to increase knowledge regarding OAT. There were some studies that assessed the relationship of the patients' knowledge about oral anticoagulants and the INR control. Some of them add to and strengthen our results such as Khudair and Hanssens et al.[15] and Tang et al.[12] results, which showed that knowledge affects the INR control positively. Kagansky et al. reported the same thing but it was only observed in elderly.[16] Conversely, there were some studies that oppose these results as Yahaya et al.,[17] Davis et al.,[18] Hasan et al.[19] and Baker et al.,[20] who showed no correlation between OAT knowledge and INR control. However, these studies faced several limitations that might affect their results' generalizability such as small sample sizes,[17],[18],[20] the lack of fully validated data collection tools,[18] the variables used in measuring the patient knowledge were limited,[18] and use of nonstandardized data collection techniques. Unexpectedly, the results showed that there was no association between the patients' knowledge and compliance as we were assuming that the more educated the patient the keener and adherent he/she will be. Wang et al.[21] reinforced our expectation as the study showed that better knowledge and higher satisfaction were associated with higher warfarin adherence. Similarly, another study revealed that knowledge about medications and self-efficacy exerts significant influence on medication adherence in patients taking warfarin.[22] However, the results contradiction could be explained due to different adherent scaling techniques, different setting places and the different sample sizes. This study showed that half the participants with fair knowledge have high education; yet, knowledge's association with level of education was statistically insignificant. This could be because the majority of the participants were females and from older generations and back then females did not have the same cultural understanding and the same opportunities to study as females are having nowadays. However, there were many studies that conflict with our result such as Khudair and Hanssens,[15] Yahaya et al.,[17] Guzman et al.,[23] and Bounda et al.,[24] which showed a correlation between knowledge and level of education. The results showed that 50% of the participants in the fair knowledge group were in the middle age group (40–59 years) whereas only 24.2% were in the young age group (20–39 years) and 25.8% were in the old age group (60+ years.). There were no significant differences found among the three groups. Matalqah et al. reinforced this result.[14] However other studies showed that patient's knowledge decline with advanced age.[12],[13],[24] As for knowledge's association with gender, there was a significant difference. About 43.8% from the total females were in the FKG while this percentage reduces to 26% from the total males who were enrolled in it. However, there were some studies with opposing results, which revealed that gender has no influence on knowledge.[12],[13] As mentioned previously, OAT requires a regular monitoring to insure that the INR values are within normal range, which is measured using laboratory-based testing. POC-INR (POCT) device for self-monitoring is considered as an alternative method to laboratory testing where the INR is determined from a drop of blood obtained by a finger stick. It has the advantage of revealing results instantly.[25] Self-monitoring (POC) INR devices will help patients in avoiding inconvenient repeated visits to the hospital just to run a simple blood test. In our study, patients were asked if they were willing to use the (POC) INR devices; the majority of patients were willing to adopt such devices. Self-management enables the patients to participate and manage their therapy in a manner similar to glucose-self-monitoring management. Using (POC) INR devices for self-monitoring is also considered cost-effective to the healthcare systems as well to the patients. A minority of the patients (25.3%) refused to use (POC) INR devices and that is because they trust the lab results more than the results obtained by the (POC) INR devices.

Study Limitations

The number of patients attending the clinic was less than what was expected (60 patients per day). Another reason is the refusal of patients to participate in the study especially male patients. This may have affected our sample where only 30.1% of the participants were males. The study was applied to KKUH anticoagulant clinic only and did not include more than one hospital, which limits the general findings in other centers. Other important factors include the fast workflow of the clinic and the fact that the clinic operates only 3 days a week.

Study Strengths

Our study's significance lies in assessing knowledge about OAT and compliance with such therapy since it has not been assessed locally. This study also estimated the willingness of patients to make use of (POC) INR devices for self-monitoring, which was not mentioned in any previous local study. A validated questionnaire was used in our study. Thus, a pilot study was not needed.


  Conclusions Top


On the basis of our study, patients had poor knowledge about OAT, but most of them were highly adherent compared to the FKG. However, significant difference was noted in INR control where the FKG had controlled INR more than the PKG. Our results showed that the level of knowledge did not affect the degree of compliance, but educational programs would definitely help patients in having less complications, less visits to the clinics and improve their routine in general. The majority of patients were accepting to the idea of using the POC-INR devices, which will help them in keeping the INR within the therapeutic range, and potentially reducing adverse clinical outcomes.

Financial Support and Sponsorship

Nil.

Conflicts of Interest

There are no conflicts of interest.

 
  References Top

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    Tables

  [Table 1], [Table 2], [Table 3], [Table 4]


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