ARTICLE
ARTICLE
Jie Sun 1,2 Purpose: We aimed to determine the effects of using evidence-based pharmacy care on
Guo-Mei Chen 1,2 satisfaction and cognition among patients with non-valvular atrial fibrillation (NVAF) and
Ji Huang 1,2 taking rivaroxaban.
1
Patients and Methods: Between July 2018 and June 2019, 200 consecutive hospitalized
Department of Pharmacy, The First
People’s Hospital of Taicang, Taicang, patients taking oral rivaroxaban, who were diagnosed with NVAF and registered in the
People’s Republic of China; 2The hospital information management system, were randomly assigned to a control group
Affiliated Taicang Hospital of Suzhou (n=100) and a study group (n=100) in a single-blind manner. The control group received
University, Taicang, People’s Republic of
China pharmaceutical care based on the general pharmaceutical care model whereas the study
group received care based on an evidence-based pharmaceutical care model. Patients’
satisfaction and cognition were evaluated regularly using questionnaires. The follow-up
time was 1 year. We compared differences in satisfaction and cognition between the two
groups after pharmaceutical-related care administered by clinical pharmacists.
Results: The study group had higher satisfaction scores than the control group after the EBP
intervention (14.58±0.88 vs.13.81±1.01, p<0.01); cognition scores were also higher in the
study group (22.58±2.19 vs 20.80±3.02, p<0.01) after the intervention. In the study group,
satisfaction was increased from a score of 10.15±1.33 before the EBP intervention. Cognition
also increased after the intervention in the study group, from a score of 9.88±4.09 pre-
intervention. In the control group, satisfaction was 10.04±1.29 before the traditional phar
maceutical care intervention, smaller than the 13.81±1.01 after the intervention (p<0.01).
Cognition in the control group was 9.83±3.51 before traditional pharmaceutical care, smaller
than the 20.80±3.02 after the intervention (p<0.01).
Conclusion: The care model based on evidence-based pharmacy care can improve patient
satisfaction and cognition, providing more comprehensive safety and efficacy of subsequent
medication.
Keywords: clinical pharmacist, evidence-based pharmacy, non-valvular atrial fibrillation,
rivaroxaban, satisfaction, cognition
undiagnosed atrial fibrillation.2–5 An epidemiological survey study was approved by the Ethics Committee of The First
in China revealed that the age-adjusted prevalence of atrial People’s Hospital of Taicang (KY-2019-21), and all
fibrillation was 0.65% and was as high as 7.5% in individuals patients provided their informed consent prior to com
over 80 years old.6 The proportion of these patients who mencement of the study.
develop ischemic stroke is approximately 5% per year, and
20–30% of patients with ischemic stroke were diagnosed Inclusion and Exclusion Criteria
with atrial fibrillation before, during, or after the event.7–9 The inclusion criteria were: (1) age ≥ 18 years; (2) confirma
Because the mortality from stroke is considerably amelio tion by electrocardiogram and echocardiography of NVAF
rated by the use of anticoagulant therapy, anticoagulants (atrial fibrillation without the following conditions: ① artifi
should be administered in most patients with atrial fibrilla cial mechanical heart valves and ② moderate to severe mitral
tion. In several large studies, novel oral anticoagulants have stenosis [mostly associated with rheumatism];17,18 (3) patients
been proven to be effective in reducing the complications of with clear anticoagulant indications and taking oral rivaroxa
stroke and thromboembolism and significantly reducing the ban (Bayer Medical Care Co., Ltd., National Drug License
risk of intracranial hemorrhage.10–13 Rivaroxaban is a direct J20180075, 10 mg/tablet); and (4) agreeing to participate in
inhibitor of factor Xa, with rapid absorption and high oral the study and having signed the informed consent form.
bioavailability. Furthermore, this drug is less affected by The exclusion criteria were: (1) patients with atrial
foods and other drugs and is convenient to administer, with fibrillation, except for valvular atrial fibrillation; (2)
no need for routine monitoring of blood clotting indexes. patients with abnormal coagulation function and severe
Evidence-based pharmacy (EBP) is an extension and bleeding tendencies; (3) patients undergoing dialysis; and
expansion of evidence-based medicine in the field of phar (4) patients taking anticoagulants other than rivaroxaban.
macy. EBP is a process of clinical practice in which drug All enrolled patients met the anticoagulant treatment
treatment decisions are made after systematically collect criteria for NVAF according to the European Society of
ing and evaluating the scientific evidence, evaluating the Cardiology (ESC) 2020 thromboembolism risk assessment
role of the drug in clinical treatment plans, and fully of atrial fibrillation: CHA2DS2-VASC score (S2 and A2
considering the needs and wishes of the patient.14–16 In represent previous stroke, transient ischemic attack, or
the past, very few approaches to pharmaceutical care have thromboembolism and age ≥75 years, respectively. These
used evidence-based methods, and amongst them, some two factors multiply a patient’s risk of thromboembolism
only provide short-term care. Although EBP offers phar and are major risk factors for thromboembolism in patients
maceutical care that is more suitable for individual patients with atrial fibrillation; therefore, the score for these two
on the basis of scientific evidence, constant improvement factors is 2 points each. A, H, C, D, Sc, and V represent
in the awareness and understanding of a disease and age 65–74 years, hypertension, congestive heart failure, dia
improving the effect of treatment takes time, as all pro betes mellitus, sex [female], and vascular disease; these
blems cannot be solved at once. In this study, participants factors each represent 1 point. The highest score is 9, and
were randomized to receive evidence-based pharmaceuti oral anticoagulants are recommended [or should be consid
cal care for an extended duration of 1 year. Subsequently, ered] for patients with CHA2DS2-VASC scores ≥1 for men
we explored whether pharmaceutical care according to and ≥2 for women. No risk factors [ie, a score of 0] indicates
EBP was superior to traditional pharmaceutical care in no need for antithrombotic therapy). After inclusion, all
terms of satisfaction and cognition, from the perspective patients were assessed for the risk of bleeding following
of patients. antithrombotic therapy using the HAS-Bled score (hyperten
sion, abnormal renal/liver function, stroke, bleeding history
or predisposition, labile international normalized ratio [INR],
Methods older age [age ≥65 years], concomitant use of drugs/alcohol),
Study Participants and the dosage of rivaroxaban was determined or adjusted
From July 2018 to June 2019, 200 hospitalized patients according to the scoring results. According to ESC
who were diagnosed with non-valvular atrial fibrillation guidelines,1 the initial dose is 20 mg without any special
(NVAF) and treated with oral rivaroxaban were randomly conditions. If there are special conditions such as advanced
divided into a control group and a study group (n=100 age or renal insufficiency, the dose will be reduced appro
patients in each group) and followed up for 1 year. This priately, such as 10–15 mg/d.
informed regarding the type of pharmaceutical care received. tent validity index of all items was 0.90, indicating that the
However, because of the nature of the study, the researchers questionnaire had good content validity.22 Additionally, the
were not blinded to the care method. Patients in the two result of the Kaiser–Meyer–Olkin test was >0.6 in a Bartlett’s
groups were provided with different pharmaceutical care sphericity test (P<0.01), indicating that the questionnaire had
interventions before, during, and after the treatment regimen. good structural validity.23 The degrees of satisfaction and
Using online (telephone and short messaging service) and cognition were assigned points during data processing.
offline (hospital visit for consultation) methods, we regularly “Very satisfied or highly aware” received 3 points, “satisfied
evaluated patients’ satisfaction (including the degree of pro or moderately aware” received 2 points, and “dissatisfied or
blem resolution, service attitude, professional level, detail of low awareness” received 1 point. In this study, the advan
response, and response time) and cognition (including of tages and disadvantages of the two monitoring or care mod
disease, drug indications, drug dosage and administration, els were compared in real-world settings.
drug effectiveness, drug safety, and monitoring indicators)
using a questionnaire. Patients were evaluated at admission Statistical Analysis
and followed up in outpatient visits, and the relevant findings IBM SPSS version 22.0 statistical software was used for data
were documented. "Patients followed
are evaluated at admission and followd
up in outpatient visits, and the relevant findings." analysis (IBM Corp., Armonk, NY, USA). Measurement data
The study group received care based on the evidence- are expressed as mean ± standard deviation (X±s). The t-test
based pharmaceutical model, as follows. According to each was used for comparisons between groups. Enumeration data
patient’s medical history and signs, relevant clinical indicators, are expressed as rate (n, %), and the χ2 test or Fisher’s exact
and drug use, clinical pharmacists fully consider patients’ test was used for comparisons between groups. Statistical
wishes and preferences according to the questions raised by significance was set at P<0.05.
patients and their families. Pharmacists search the relevant
literature, evaluate the level of evidence according to the
literature type, use meta-analysis-based methods to screen
Results
for effective and reasonable evidence, then sort and analyze Baseline Comparison Between Patient
We analyze and the evidence. After systematic analysis and comprehensive Groups Before the Study
evaluate
comprehensively. evaluation, clinical pharmacists provide objective and reason During implementation of the pharmaceutical care inter
able suggestions to patients, using appropriate language, ventions, no patients were lost to follow-up or discontinued
according to the relevant evidence (Table 1 and Figure 1).1,19 their participation in the study group, except one patient in
The control group received care based on the general or the control group who withdrew their participation owing to
traditional pharmaceutical care model, as follows. Patients financial reasons. Basic information on the patients in both
are monitored according to the clinical experience of phar groups is presented in Table 2. We analyzed data of age, sex,
macists, medication instructions, and individual case reports. educational level, CHA2DS2-VASC score, comorbidities,
"Patients are monitored based on pharmacists' clinical experience, and creatinine clearance rate for patients in both groups; the
medication instructions, and individual case reports."
observed difference was not statistically significant (P>0.05
Evaluation Criteria and Indicators
in all cases). Therefore, the basic information regarding all
Prior to implementing the two types of pharmaceutical care,
enrolled patients was comparable.
participants in both groups were required to complete
a questionnaire survey regarding their satisfaction and cogni
tion. The relevant indicators were monitored monthly and all Comparison of Study Results Between
concerns, questions, and outcomes were recorded during the Patient Groups
intervention period. After the intervention, a questionnaire Comparison of Satisfaction and Cognition Between
survey was again conducted for each patient to compare the Patient Groups Before Intervention
degree of satisfaction and cognition between the two groups There was no significant difference in the degree of satis
following the respective interventions. The questionnaire faction and cognition between the study group and control
Class I Evidence and/or general agreement that a given treatment or procedure is beneficial, useful, Is recommended or
effective. is indicated
Class II Conflicting evidence and/or divergence of opinion about the usefulness/efficacy of the given treatment or procedure.
Class III Evidence or general agreement that the given treatment or procedure is not useful/effective, Is not recommended
and in some cases may be harmful.
Level of evidence A Data derived from multiple randomized clinical trials or meta-analyses.
Level of evidence B Data derived from single randomized clinical or large non-randomized studies.
Level of evidence C Consensus of opinion of the experts and/or small studies, retrospective studies, registries.
group before the implementation of pharmaceutical care response, and total satisfaction (P<0.05). There was no sig
(P>0.05), as shown in Table 3. nificant difference in the degree of problem resolution and
response time (P> 0.05). The comparison of cognition
Comparison of Satisfaction and Cognition Between between the two groups after implementation of pharmaceu
Patient Groups After Intervention tical care showed statistically significant differences with
We compared satisfaction among the two groups after the respect to disease, dosage and administration of drugs, effec
different interventions. We observed statistically significant tiveness and safety of drugs, and total cognition (P<0.05).
differences in service attitude, professional level, detail of There was no significant difference regarding indications and
medication monitoring indexes (P>0.05), as shown in Table 4.
Discussion
Effects of an Evidence-Based
Pharmaceutical Care Model on Patient
Satisfaction and Cognition
Before the implementation of pharmaceutical care inter
ventions in the study group and control group, there was
no significant difference between groups regarding the
degree of satisfaction and cognition. After implementation
Figure 1 A decision-making process to establish a pharmacy care plan according to of the different care interventions, satisfaction and cogni
medical/pharmacy evidence that is compatible with national health policy and
tion were significantly improved among participants in the
patient factors.
Abbreviation: EBP, evidence-based pharmacy.. two groups, and the difference was statistically significant
Education 0.94
Primary school and below 58 58.0% 56 56.6%
Table 3 Comparison of Satisfaction and Cognition Between Two Groups Before Intervention (X±s)
Items Study Group Control Group P
Table 4 Comparison of Satisfaction and Cognition Between Two Groups After Intervention (X±s)
Items Study Group Control Group P
Table 5 Comparison of Satisfaction of Two Groups Before and After Intervention (X±s)
Items Study Group P Control Group P
Table 6 Comparison of Cognition of Two Groups Before and After Intervention (X±s)
Items Study Group P Control Group P
(P<0.05), indicating the need for implementation of evi summarize the evidence for patients in the study group,
dence-based pharmaceutical care. these patients were willing to spend more time with
After implementation of the different pharmaceutical a clinical pharmacist. Because pharmacists spent
care models, a comparison between the participant a relatively long contact time with patients, they could
groups showed that patients who received evidence- better understand the needs and preferences of their
based pharmaceutical care had more obvious satisfaction patients, answer treatment-related questions in more
in terms of the service attitude, professional level, and detail and with greater authority, and provide more
detail of response. In terms of response time, although appropriate medication guidance. Furthermore, there
more time was needed to collect, evaluate, and was no significant difference for the degree of problem
solving, which may be related to the fact that rivarox drugs that are suitable for their clinical needs within the
aban had not been used for a long time in the study appropriate time, in doses that meet their individual needs,
population; the questions raised about rivaroxaban over and at the lowest cost to them and to the community. When
lapped with evidence-based information in the instruc making a drug treatment decision, understanding the needs of
tions and guidelines. Moreover, rivaroxaban is a new patients and seeking reliable evidence are complicated by the
drug and therefore, evidence about this drug is relatively increasing number of electronic information resources, as well
lacking. "Both groups are also similar in terms of cognition about
drug indications and medication monitoring indicators."
as the increasing number and types of drugs on the market.
Both groups were also similar in terms of cognition about Patients have different conditions and different expectations of
drug indications and medication monitoring indicators. This treatment. Not all data have the same value in terms of
may be related to the fact that the indications for rivaroxaban evidence.19 Obtained data require extensive scientific evalua
in China are relatively clear and easy to remember after tion and interpretation, and different sources of evidence pro
repeated explanation. At the same time, rivaroxaban does vide different levels of evidence in decision making.25,26
not require routine monitoring and has little interaction with In this study, we innovatively applied EBP care among
other drugs or foods, and a regular review is only needed patients using the principle of PICO-S (Participants’ research
according to renal function. In this study, patients were object, Intervention, Comparison, Outcome, Study design).
monitored with less frequency, and insignificant differences PICO-S emphasizes that patients should actively participate
in treatment cognition were observed. However, following in the treatment process to establish a good relationship
EBP care, cognition in other dimensions showed obvious between pharmacists and patients. Clinical pharmacists
improvement, indicating that through EBP, full and detailed should fully understand the needs and preferences of patients,
pharmacological care can help to improve patients’ under as well as the characteristics of their disease, and they should
standing of their disease and medications, thereby improving then search the relevant evidence, evaluate the level of evi
overall medication compliance and clinical efficacy and dence, and conduct systematic analysis (eg, meta-analysis) of
reducing adverse events. the evidence. Finally, clinical pharmacists should use appro
priate language to make recommendations for individualized
treatment decisions, which adds additional value with respect
Importance of Evidence-Based to clinical outcomes.27,28
Pharmaceutical Care The ESC guidelines for atrial fibrillation also emphasize
Under a background of the urgent pursuit of health-related that patients should be actively involved in treatment deci
knowledge and the contradictory relationship between sup sions. A patient study on the influence of direct oral antic
ply and demand for medical care, the relationship between oagulants (DOACs) on stroke prevention in atrial fibrillation
doctors and patients is becoming increasingly strained. showed that greater patient involvement in decision making
Patients are desperate to understand their illness but doctors can help to prevent and address negative effects on their daily
are too busy to provide a detailed explanation to each patient. life to improve compliance and overall satisfaction with
Additionally, with the development of modern technologies, treatment and may improve prognosis and increase uptake
patients can acquire non-professional medical knowledge via of DOACs.29 In another study of pharmacists’ experiences in
the Internet. However, specious suggestions and conclusions clinical pharmaceutical care during the COVID-19
from online platforms may further aggravate the already pandemic,30 many pharmacists working in hospitals had to
strained relationship between doctors and patients. The pro adjust their working mode and were reassigned to the inten
vision of high-quality pharmaceutical care can alleviate the sive care unit. These pharmacists participated in the provi
aforementioned problem, to some extent. As early as 2006, sion and evaluation of evidence in their new position, which
the World Health Organization and the International offered a new reference for doctors in treating patients.
Federation of Pharmacy jointly compiled a pharmacist’s Owing to the severity of the pandemic, many patients could
manual entitled “Developing Pharmacy Practice-A Focus not enter a hospital to receive treatment from specialists but
on Patient Care,”24 which clearly proposes the use of evi could only seek care in the community. Pharmacists in the
dence-based medicine concepts and methods in pharmacy community could fully understand the needs and fears of
practice. patients through communication with their patients, provid
The ultimate purpose of evidence-based pharmaceutical ing patients with evidence-based care after evaluation and
care is rational drug use, which requires that patients receive participating in the compilation and dissemination of
"Pharmacists working in hospitals have to adjust their working
mode and are reassigned to the intensive care unit."
educational materials. Verbal advice could also be provided follow-up period could have been extended and the fre
to patients, members of the public, and health professionals. quency of follow-up could have been increased (preferably
During the pandemic, pharmacists have become an important to once a month or more). Particularly in the case of out
member of the treatment team as a bridge between doctors patients, detailed follow-up should be conducted before and
and patients, which has been affirmed by doctors, and have after treatment, which can assist in identifying additional
improved patients’ satisfaction with pharmacists and their problems. In addition to evidence regarding basic diseases,
understanding of their disease. Similarly, the evidence- drug science, and humanistic care, most of the evidence-
based pharmaceutical care model has received positive based pharmacy services in this study were according to
reports in terms of monitoring adverse drug reactions and patients’ questions. This has led to incidents that may affect
the rational use of antibiotics.31,32 This can significantly the results. In future work, an initiative to help guide patients
reduce the occurrence of adverse reactions and improve the in identifying problems and that uses EBP to solve these
rate of reasonable antibiotics use. problems should be adopted. Due to the single blind method
The implementation of evidence-based pharmaceutical used in this study, there may be subjective bias of the
care has significantly improved patient satisfaction and cogni researcher, but this is the nature of the experiment dictates
tion. In clinical practice and in other previous studies, it has that the two groups need to be treated differently.
been shown that encouraging patients to participate in treat
ment decision making and evaluating the available evidence
are crucial. Only by thoroughly understanding patients’ needs
Implications for Future Research and
and preferences as well as their existing difficulties and past Clinical Practice
drug experiences can drug treatment be optimized in patients Relevant studies have pointed out that pharmacists are now
(literature).14–16 Clinical pharmacists scientifically evaluate extensively involved in the treatment and management of
the evidence to arrive at a conclusion through systematic chronic diseases, including the distribution of educational
analysis (such as meta-analysis), then recommend the most material, review of drug therapy, as well as the provision of
appropriate treatment to patients using language that the pharmaceutical advice to patients. Pharmacist-led care has an
patient can understand. Patients can receive individualized impact on the clinical progression of chronic diseases; how
treatment, which can help to improve patient compliance and ever, determining which method of care can best serve
enhance the effect of treatment. Of course, it takes time for the patients deserves further discussion.33 We believe that evi
pharmacist and patient to develop a trusting relationship. dence-based pharmaceutical care in patients with NVAF who
In conclusion, although thorough systematic analysis and are treated with rivaroxaban can be comprehensive and
comprehensive evaluation of the available evidence in EBP accurate in mitigating issues associated with the use of this
care of patients requires a slightly longer time than usual care, drug. The care model in this study can enable patients to have
patients’ desire for high-quality medical care that meets their a more comprehensive understanding of the advantages and
health needs can be satisfied and patients’ knowledge levels disadvantages of the drug and improve patient satisfaction
can be increased. EBP care can also promote the development and cognition. Thus, quality of medical treatment can be
of high-quality professional skills among pharmacists. assured, the doctor–patient relationship can be improved,
safety and effectiveness of drug use can be enhanced, and
Strengths and Limitations the burden on clinicians can be reduced. Whether there are
Compared with previous studies, this study included more significant differences in patient outcomes, readmission
homogeneous populations and a clear control group. It used rates, test indicators, and various economic indicators
statistical methods to compare the satisfaction and cognition requires further follow-up study. Educational institutions of
of these patients under different pharmaceutical care modes pharmacy in many countries have established courses related
on the premise that there was no statistical difference at to evidence-based practice or that require pharmaceutical
baseline. This study shows obvious statistical differences in students to master evidence-based practice skills.34 As mem
satisfaction and cognition, which can better reflect the char bers of the pharmaceutical profession, pharmacists should
acteristics and advantages of evidence-based pharmacy. It keep pace with the times, constantly improving their profes
also illustrates the necessity of implementing evidence- sional skills, such as by applying the abovementioned
based pharmacy. But it also has some shortcomings. The approaches to other diseases and drugs and by constantly
sample size in this study was not sufficiently large; also, the improving pharmaceutical care based on scientific methods.
28. Toklu HZ, Hussain A. The changing face of pharmacy practice and 31. Han AL. Study on the application value of evidence-based pharmacy
the need for a new model of pharmacy education. J Young Pharm. to drug adverse reactions. Electron J Clin Med Lit. 2018;5(16):152.
2013;5(2):38–40. doi:10.1016/j.jyp.2012.09.001 32. Yao JJ. Effect of evidence-based pharmacy on rational use of anti
29. Medlinskiene K, Richardson S, Fylan B, et al. Patient perspectives on biotics in clinic. Medicine. 2016;3:145.
factors affecting direct oral anticoagulant use for stroke prevention in 33. Jia X, Zhou S, Luo D, et al. Effect of pharmacist-led cares on
atrial fibrillation. Patient Prefer Adherence. 2021;15:953–966. medication adherence and inhalation technique in adult patients
doi:10.2147/PPA.S302016 with asthma or COPD: a systematic review and meta-analysis.
30. Paudyal V, Cadogan C, Fialová D, et al. Provision of clinical phar J Clin Pharm Ther. 2020;45(5):904–917. doi:10.1111/jcpt.13126
macy services during the COVID-19 pandemic: experiences of phar 34. Zhang LL, Yi L, Die HU, et al. Systematic review of evidence-based
macists from 16 European countries. Res Social Adm Pharm. 2020;17 pharmacy definitions and literature. J CN EBM. 2011;11(1):7–13.
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