Journal of Clinical and Diagnostic Research, ISSN - 0973 - 709X

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On Sep 2018




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On Aug 2018




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MBBS, MD (Pathology),
Sanjay Gandhi institute of trauma and orthopedics,
Bengaluru.
On Aug 2018




Dr. Mamta Gupta,
"It gives me great pleasure to be associated with JCDR, since last 2-3 years. Since then I have authored, co-authored and reviewed about 25 articles in JCDR. I thank JCDR for giving me an opportunity to improve my own skills as an author and a reviewer.
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Dr. Mamta Gupta
Consultant
(Ex HOD Obs &Gynae, Hindu Rao Hospital and associated NDMC Medical College, Delhi)
Aug 2018




Dr. Rajendra Kumar Ghritlaharey

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Thanking you
With sincere regards
Dr. Rajendra Kumar Ghritlaharey, M.S., M. Ch., FAIS
Associate Professor,
Department of Paediatric Surgery, Gandhi Medical College & Associated
Kamla Nehru & Hamidia Hospitals Bhopal, Madhya Pradesh 462 001 (India)
E-mail: drrajendrak1@rediffmail.com
On May 11,2011




Dr. Shankar P.R.

"On looking back through my Gmail archives after being requested by the journal to write a short editorial about my experiences of publishing with the Journal of Clinical and Diagnostic Research (JCDR), I came across an e-mail from Dr. Hemant Jain, Editor, in March 2007, which introduced the new electronic journal. The main features of the journal which were outlined in the e-mail were extensive author support, cash rewards, the peer review process, and other salient features of the journal.
Over a span of over four years, we (I and my colleagues) have published around 25 articles in the journal. In this editorial, I plan to briefly discuss my experiences of publishing with JCDR and the strengths of the journal and to finally address the areas for improvement.
My experiences of publishing with JCDR: Overall, my experiences of publishing withJCDR have been positive. The best point about the journal is that it responds to queries from the author. This may seem to be simple and not too much to ask for, but unfortunately, many journals in the subcontinent and from many developing countries do not respond or they respond with a long delay to the queries from the authors 1. The reasons could be many, including lack of optimal secretarial and other support. Another problem with many journals is the slowness of the review process. Editorial processing and peer review can take anywhere between a year to two years with some journals. Also, some journals do not keep the contributors informed about the progress of the review process. Due to the long review process, the articles can lose their relevance and topicality. A major benefit with JCDR is the timeliness and promptness of its response. In Dr Jain's e-mail which was sent to me in 2007, before the introduction of the Pre-publishing system, he had stated that he had received my submission and that he would get back to me within seven days and he did!
Most of the manuscripts are published within 3 to 4 months of their submission if they are found to be suitable after the review process. JCDR is published bimonthly and the accepted articles were usually published in the next issue. Recently, due to the increased volume of the submissions, the review process has become slower and it ?? Section can take from 4 to 6 months for the articles to be reviewed. The journal has an extensive author support system and it has recently introduced a paid expedited review process. The journal also mentions the average time for processing the manuscript under different submission systems - regular submission and expedited review.
Strengths of the journal: The journal has an online first facility in which the accepted manuscripts may be published on the website before being included in a regular issue of the journal. This cuts down the time between their acceptance and the publication. The journal is indexed in many databases, though not in PubMed. The editorial board should now take steps to index the journal in PubMed. The journal has a system of notifying readers through e-mail when a new issue is released. Also, the articles are available in both the HTML and the PDF formats. I especially like the new and colorful page format of the journal. Also, the access statistics of the articles are available. The prepublication and the manuscript tracking system are also helpful for the authors.
Areas for improvement: In certain cases, I felt that the peer review process of the manuscripts was not up to international standards and that it should be strengthened. Also, the number of manuscripts in an issue is high and it may be difficult for readers to go through all of them. The journal can consider tightening of the peer review process and increasing the quality standards for the acceptance of the manuscripts. I faced occasional problems with the online manuscript submission (Pre-publishing) system, which have to be addressed.
Overall, the publishing process with JCDR has been smooth, quick and relatively hassle free and I can recommend other authors to consider the journal as an outlet for their work."



Dr. P. Ravi Shankar
KIST Medical College, P.O. Box 14142, Kathmandu, Nepal.
E-mail: ravi.dr.shankar@gmail.com
On April 2011
Anuradha

Dear team JCDR, I would like to thank you for the very professional and polite service provided by everyone at JCDR. While i have been in the field of writing and editing for sometime, this has been my first attempt in publishing a scientific paper.Thank you for hand-holding me through the process.


Dr. Anuradha
E-mail: anuradha2nittur@gmail.com
On Jan 2020

Important Notice

Original article / research
Year : 2009 | Month : August | Volume : 3 | Issue : 4 | Page : 1663 - 1670 Full Version

Factors Associated with Warfarin Therapy Knowledge and Anticoagulation Control among Patients Attending a Warfarin Clinic in Malaysia


Published: August 1, 2009 | DOI: https://doi.org/10.7860/JCDR/2009/.550
YAHAYA A H M *, HASSALI M A **, AWAISU A***, SHAFIE A A ****

*( M.Pharma) (Clin. Pharm),BPharm(Hons), Master of Clinical Pharmacy Pharmacy DepartmentHospital Teluk Intan ** (PhD),Senior Lecturer Discipline of Social & AdministrativePharmacy, School of Pharmaceutical Sciences, ***( M.Pharma) (Clin. Pharm) Doctoral Research Fellow Discpline of Clinical Pharmacy,**** (PhD)Discipline of Social & Administrative Pharmacy School of Pharmaceutical Sciences Universiti Sains Malaysia 11800 Penang,( Malaysia)

Correspondence Address :
Mohamed Azmi Ahmad Hassali,
Ph: +6046533888 ext. 4085,Fax: +604-6570017.
E-mail address:azmihassali@usm.my

Abstract

Objective: To determine the factors that correlated with the patient’s knowledge of warfarin therapy, the level of medication adherence and INR control.
Methods: A cross-sectional survey was conducted at the Warfarin Clinic of Hospital Teluk Intan, Malaysia. The systematic random sampling method was used in sample selection and face-to-face interviews using standard questionnaires were administered to determine the demographic characteristics, the patient’s knowledge of warfarin therapy and medication adherence. Medical records were reviewed to determine anticoagulation control during the study period.
Results: A total of 52 patients were enrolled in the survey (mean ± SD age of 58.73  9.55 years), with a response rate of 95%. A large proportion (63.5%) of the respondents had only primary school education and 71.2% were low-income earners (below RM500 per month). About 69% of the respondents were able to read and 53.8% were able to understand Malay (the national language of the country). A majority of the patients (98%) had verbal medication education through medical or nursing officers. Only 44.2% of patients knew about their medications, but the medication adherence was fairly good at 76.1%. The study showed that age, income level, level of education, and literacy in various languages were significantly associated with the patient’s knowledge on warfarin therapy (p< 0.05). The study also showed a significant difference between those patients who knew/did not know about their medications in terms of warfarin therapy knowledge (p<0.05).
Conclusion: Age, income, educational level, literacy and race were significantly correlated with the patient’s knowledge of anticoagulation. The study did not find any association between anticoagulation control and the knowledge of anticoagulation.
Practice Implications: The disadvantaged groups receiving anticogulation therapy, including the low-income earners, the elderly, the less-educated and the illiterate, should be given utmost care and attention.

Keywords

warfarin, knowledge, patients, education, anticoagulation control.

Introduction
Warfarin has been the mainstay oral anticoagulant agent for the last several decades despite its narrow therapeutic index and difficulties to use (1),(2). It has become a successful agent for the medical management of thromboembolic diseases such as chronic atrial fibrillation, mechanical heart valve replacement, deep vein thrombosis, pulmonary embolism, and valvular heart disease, among others (3). This has led to a dramatic increase in the number of patients receiving warfarin therapy and those who are referred to anticoagulation clinics. However, warfarin therapy is plagued by the need to frequently fine-tune dosage, based on the International Normalized Ratio (INR), the relatively large variability in dosage requirements based in part on CYP2C9 activity, its slow action dependent onset and offset on the depletion and restoration of vitamin K-dependent clotting factors and many drug interactions (4).

Interactions with other drugs, dietary intake, poor adherence with medication and deficiency in patient knowledge are factors associated with non-therapeutic treatment outcomes (3). Therefore, it is pertinent to assess the patient’s knowledge of and adherence to warfarin therapy. Adhering to prescribed recommendations during treatment is essential, but managing and educating patients with low literacy skills is a challenge for health care providers (3). The patient’s knowledge on warfarin has been shown to be a determinant of anticoagulation control (5) and patient education and counseling is an integral component of a successful warfarin therapy.

Several factors could play a role on the patient’s knowledge on warfarin therapy, adherence to its treatment and overall management of the therapy. A multidisciplinary education program may improve the patient’s knowledge on warfarin therapy, drug adherence, as well as adherence to medical advice (6). Malaysia, a multiracial Southeast Asian nation with Malay, Chinese, and Indians as the majority, is an entity with cultural diversities and distinct genetic variability among the several races. These diversities have important clinical implications on how therapeutic agents with genetic polymorphism such as warfarin, should be used in practice, as well as the impact of cultural practices and knowledge on warfarin therapy. This study therefore, aims to determine the sociodemographic factors associated with the patient’s knowledge on warfarin therapy, the level of therapy adherence, and INR control.

Material and Methods

Setting
The study was conducted at the Warfarin Clinic of Hospital Teluk Intan, which operates on a once weekly-basis (every Wednesday). The clinic was established in August 1999 to accommodate the expansion in the number of patients undergoing outpatient anticoagulation therapy (i.e. warfarin). A Warfarin dosing protocol was designed to ensure a more efficient and standardized system of evaluating anticoagulation therapy. It consists of dosage initiation, maintenance and adjustment of warfarin based on diagnosis, intervention required if the INR is outside normal therapeutic range and a recommended schedule for the patient’s follow-up. All patients on warfarin therapy are referred to this clinic for review and management by a physician. The patient has his/her INR checked before seeing the physician for further management.

Study Design
This was a cross-sectional study conducted over 4 months. A face-to-face interview using a structured questionnaire was performed by trained data collectors at the anticoagulation clinic. During the study, the patient’s current and previous INRs were also assessed to evaluate the level of anticoagulation control.

Sampling
A randomized systematic sampling was used in the patient’s selection. A minimum sample size of 47 patients was needed to detect an estimation of 20% patients who had poor knowledge on warfarin therapy, with 10% accuracy (EpiInfo version 6). Patients eligible for inclusion in the study were those who had been to the anticoagulation clinic for more than 5 visits. This criterion was set up because most previous studies showed the patient INR to be stable after the fifth visit. Fifty-two patients responded to the questionnaires. The medical records of the selected patients were then reviewed to assess the overall management of warfarin therapy, including the 5 most recent INRs recorded and warfarin doses prescribed.

Data Collection Procedure and Instruments
Data were collected using a standardized form and two questionnaires (one for adherence assessment and the other for knowledge evaluation). The collected data included: demographic information such as the highest level of education, household income and literacy level; indication for and duration of warfarin therapy; and concurrent drug therapies. The patient’s source(s) of information on their warfarin therapy, access to the warfarin booklet and understanding of its contents were also recorded. The patient’s adherence to warfarin therapy was assessed through counting of tablets and a 4-item Moriskey questionnaire during the session.

The questionnaire to assess warfarin therapy knowledge was designed in 3 major Malaysian languages; Malay, Chinese and Tamil. It was validated by an expert panel consisting of 2 physicians and 2 senior pharmacists employed at the study hospital. The forward-backward translation method was used in translating the questionnaire into each language, to ensure conceptual equivalence. Face-to-face interviews were conducted by three researchers trained in questionnaire administration, who did not work in the clinic, as an effort to decrease potential bias.

The patient’s knowledge of warfarin therapy was also evaluated during the interview sessions. The standardized assessment of knowledge consisted of questions that were intended to determine the patient’s knowledge of: indication, dose, mechanism of action, administration time, importance of blood monitoring, food-warfarin interactions, drug-warfarin interactions, actions to be taken in case of missed doses, adverse effects and the actions to be taken if an adverse effect occurs. The precautionary steps on certain occasions such as warfarin in pregnancy and before tooth extraction, were also asked. For the purposes of analysis, each question was assigned a point and the total point obtained, indicated the patient’s overall knowledge on warfarin therapy.

The patient’s medical profiles were further reviewed to determine the indication of warfarin therapy. The 5 most current INR values were reviewed and compared with target INRs specified in the local anticoagulant protocol. An audit concerning the management of anticoagulation was also conducted. The anticoagulation protocol provided guides for healthcare providers in patient management and ensured uniformity and continuity of service. The audit of patient management helped the investigators to ensure that other factors were considered in the analysis.

Statistical Analysis
Descriptive statistics were used to present the data on demographic characteristics, literacy level, adherence to warfarin therapy, and knowledge of warfarin therapy. Continuous variables were expressed as mean ± standard deviation (SD), whereas categorical variables were expressed as percentages and frequencies. Factors thought to contribute to the patient’s knowledge on warfarin therapy and adherence, were analyzed using correlation analysis. The a priori level of significance for all analyses was two-tailed at 0.05. All statistical analyses were performed using SPSS software, version 11.0.

Results

A total of 55 patients were selected for the study, with 52 responding to all the study questionnaires (95% response rate). The male to female ratio of the participants was 1.1:0.9. The mean age ± SD of the respondents was 58.73 ± 9.55 years, with nearly half of them in the 60-79 year-old category. Two-thirds of the study patients were Malay and an overwhelming proportion of the patients (86.5%) had been to the anticoagulation clinic for more than 10 times. Moreover, the vast majority of the patients (63.5%-71.2%) belonged to the low household income category and had only primary school education. Most of the patients lived within more than 10 kilometers radius away from the clinic. The majority (61.5%) of the patients had received warfarin therapy due to chronic atrial fibrillation. The detailed patient’s characteristics are presented in (Table/Fig 1).

Opportunities to receive education on warfarin therapy were determined during the interview sessions. On normal clinic days, patients should receive counseling from the prescriber or nurses regarding warfarin therapy as soon as possible, after initiation of therapy. In this study, no documentation was found in the patient’s medical records, on whether the patients had been educated on warfarin therapy. However, the majority of the patients (94.2%) admitted that they received education on warfarin from medical officers (93.9%). Nearly all the patients were given a warfarin booklet, but only 78.4% indicated that they read it. Of this, 85% reported that they understood the contents of the booklet.

The international normalized ratios (INRs) for all patients were reviewed. The complete medical records of two patients could not be found and they were therefore excluded from further evaluations. Only 10% of study participants had 80% or more of their 5 consecutive INR readings within the targeted range. About 16% had 4 to 5 (80-100%) INR readings outside the target range and 6% had 3 (60%) INR readings within the supratherapeutic range (Table/Fig 2).

A review of the patient’s medical records and appointment schedules found that all patients adhered to the appointment schedules of the clinic. The patient’s warfarin therapy adherence was assessed using the 4-item Moriskey instrument and was further verified by pill counting. A total of 12 patients (23.1%) had poor adherence when assessed using Moriskey instrument; 10 patients (19.2%) claimed that they had sometimes forgotten to take medications, while the other 2 claimed that they had inadequate medications refill (an insufficient supply of medication). About 58% of the non-adhered patients missed a warfarin dose once a month, whereas 25% and 17% missed 2 to 4 doses and at least 5 doses per month, respectively. Patients were asked further questions about the awareness of their current warfarin dose and this was correlated with what was prescribed in the medical profile. This study found that the proportion of agreement of self-reported awareness of the warfarin dose by the patient, as compared to the assessments in medical records, was 92%, (N=52) kappa = 0.923, p<0.001. Only 44.2% were aware of the warfarin doses prescribed to them (Table/Fig 3)

Assessment of the knowledge on warfarin therapy was conducted using the knowledge questionnaire. The results showed that a majority (67.3%) of the patients had poor knowledge of different tablet dosage forms and their strength. The knowledge concerning the indication for warfarinization was also assessed. The proportion of patients who knew the indication and those who did not, was almost equal. Nearly 71.2% of the patients understood the mechanism of action of warfarin. The patient’s knowledge was assessed, regarding the following: missed doses and actions to be taken, importance of INR monitoring, warfarin-food interactions, warfarin-drugs interactions, adverse events of warfarin and actions to be taken when they are perceived to occur and precautions to be taken while on warfarin therapy. (Table/Fig 4) summarizes these key findings.

The overall score for each patient’s knowledge on warfarin therapy was calculated (i.e. a point was given for each correct answer). An overall total score above 80% was considered as good knowledge, 50% to 80% as fairly good and less than 50% as poor knowledge. (Table/Fig 5) shows the overall scores. (Table/Fig 6) presents the factors that might be associated with the patient’s knowledge on warfarin therapy. Correlation analysis showed that the patient’s knowledge on warfarin therapy was significantly associated with their age (r = -0.367, p = 0.007), household income (rs = 0.291, p = 0.036), educational level (rs = 0.328, p = 0.018) and the number of readable languages (rs = 0.387, p = 0.005).

The average percentage of INR that achieved targeted range (over 5 readings) was 41.92 ± 25.44, with a median of 40%. None of the factors was associated with the anticoagulation control.


Discussion

Unlike most previous studies on the patient’s knowledge on warfarin therapy (5), this study also assessed the incidence of the international normalized ratio (INR) at or outside the targeted range via the assessment of the patient’s medical records. Ninety percent of the 50 patients reviewed, had an INR that might indicate an inadequate therapy or over-warfarinization. However, no relationship was found between the patient’s knowledge and anticoagulation control. This was contrary to a previous study where the patient’s education and knowledge were identified as important factors which could affect the anticoagulation control (5). Prior knowledge of warfarin has been associated with a decreased risk of bleeding. Written and verbal information has been shown to improve anticoagulation control. While past studies suggest that patient education may be associated with better clinical outcomes, doubts remain about the effectiveness of patient education strategies (7).

Perhaps, there could be some explanations for the low patient’s knowledge of anticoagulation. There might be flaws in the nature and extent of information provided by healthcare personnel on anticoagulation, as well as the method of delivery. This was shown by a low score of the patient’s knowledge in those patients who claimed to be educated by prescribers or nurses. A lack of knowledge and skills among health care professionals providing anticoagulation services might contribute to reluctance in advising patients on the risks and complication of anticoagulation. More widespread dissemination of guidelines to the medical staff is required, with specific instructions for counseling patients receiving anticoagulation. The other possible factor involved, might be the patient’s inability to understand and retain the advice given. Poor doctor-patient communication has been well described for other chronic conditions (8). More effective communication arises from understanding the patient’s expectations, involving patients in negotiating their treatment plan and the continuity and accessibility of the staff. Better levels of the knowledge of the patients may also be achieved if the information is reinforced by simple measures such as repetition or use of written materials. The availability of a non-physician counselor such as a clinical pharmacist or a nurse practitioner, has also been shown to increase the patient’s knowledge about medical treatments (9).

There was a difference in the patient’s knowledge of anticoagulation among the different age groups. The elderly patients had poor knowledge on the subject as compared to the younger ones. This might be due to the inability to remember, and to the fact that the former category is often given many medications. Improvement in s enhancing the knowledge of anticoagulation among elderly patients is needed, as they are at a high risk of side effects. There is also a need of specific anticoagulation dosing and introduction of an initiation protocol for the elderly, as a study showed that the protocol performs better than empirical dosing for older patients (10).

Household income and education level are the other factors which are found to be associated with the patien’s knowledge of anticoagulation. Patients with low anticoagulation knowledge were found to have low levels of education and low household income. For patients with low household income, medication and treatment adherence may be major problems. A study on the knowledge of cardiovascular disease among the Canadian population, found that patients from a low socioeconomic background had poor knowledge of disease11. Thus, the educational approach in enhancing the patient’s knowledge should consider individual differences.

Illiteracy has become an increasingly important problem, especially, as it relates to health care. Literacy is defined as the basic ability to read and speak in the common language (Malay language in the Malaysian context). Health care professionals cannot assume that all patients know how to read, but direct questioning based on the assumption that the inability to read amounts to illiteracy often causes shame and embarrassment. Assessing a patient’s reading skills in the clinical setting is important and provides insight into an individual’s ability to function adequately in the healthcare environment. In this study, the illiteracy rate was almost 30%. This was probably because a majority of the study patients had low levels of education. The illiteracy levels also had a significant correlation with the knowledge of poor patients towards warfarin therapy. In the United States, researchers have found that illiteracy directly correlated to poorer health and disease.12. The consequences of health illiteracy are lack of knowledge about medical care, lack of understanding of services, poorer adherence rate, increased rate of hospitalization and increased health care cost (13).

The purpose of written patient education materials (warfarin booklet in this case) is to provide information about health promotion, diagnostic procedures, treatments and medications. Patients need information that they can understand in order to undertake self-care behaviours. The potential for serious adverse effects of anticoagulation therapy requires that written patient informational material is at a reading level that patients can understand. Older patients with poor reading abilities are at a greater risk of not following instructions because of the difficulty that they have in formulating questions to ask to their healthcare provider and are further hampered by the burden of shame and embarrassment associated with illiteracy. Healthcare providers have a responsibility to use education materials that will meet the unique learning needs of patients with low literacy. Understandable information is important in reducing health care barriers to patient education and improved patient outcomes. There are many steps which can be taken to improve patient communication. Providing visual materials (for instance photos or drawings) while verbally explaining instructions to patients could increase the probability that patients will recall the information when compared to only providing instruction verbally. Another medium that could be used is the audiotape. In one study, researchers found that patients with low literacy chose an audiotape over a paper tool written at an appropriate grade level (14),(15).


Conclusion

Warfarin still remains the drug of choice for patients with thromboembolic diseases, and therefore appropriate educational strategies must be considered. The patient’s age, educational status and household income were significantly associated with his/her knowledge of anticoagulation.

Practice Implications
The disadvantaged groups receiving anticogulation therapy, including the low-income earners, the elderly, the illiterates, and those with low levels of education, should always be given utmost care and attention to enhance their knowledge and awareness on warfarin therapy.

Acknowledgement

We hereby acknowledge with thanks the assistance of the under-listed persons during the conduct of this study:Director of Hospital Teluk Intan, Amutha Selvaraj, BPharm (Hons), RPh, Lim Gean Yee, BPharm (Hons), RPh, Norirmawath Shaharuddin, BPharm (Hons), RPhRokiah Isahak, BPharm (Hons), MPharm(Clin.Pharm), RPh

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