Cross-Cultural Translation into Brazilian Portuguese and Validation of the Oral Anticoagulation Knowledge Tool (AKT-Br)

ABSTRACT Introduction: Oral anticoagulants are the treatment of choice for diverse types of coagulation disorders. Warfarin is widely used by the Brazilian population, possibly due to its lower cost than other oral anticoagulants. However, it has a high risk of serious adverse effects if used incorrectly. The Anticoagulation Knowledge Tool (AKT) can assess a patient's knowledge about her/his oral anticoagulant therapy and can assist health professionals in identifying patients with difficulties in adherence. This study aimed to translate, culturally adapt, and validate the AKT into Brazilian Portuguese. Methods: After a standard forward-backward procedure to translate the AKT into Brazilian Portuguese (AKT-Br), a version of the instrument was applied in three groups (patients, pharmacists, and the general population). The reliability of the AKT-Br was tested using an internal consistency measure and test-retest. The validity of the instrument was confirmed with data from the contrasted groups. All statistical analyses were performed with RStudio. Results: The median scores obtained with the AKT-Br were 29.0, 17.0, and 7.5 for pharmacists, patients, and the general population, respectively (maximum score of 35 points). There was moderate internal consistency for the instrument and test-retest reliability was satisfactory. Analysis of variance for validity of the groups revealed a significant relationship between the total score and the evaluated groups. Conclusion: The ATK-Br is a reliable and valid tool to assess knowledge about oral anticoagulants. AKT-Br can be used in clinical practice as an auxiliary tool to improve patient care through personalised educational interventions.

Cross-Cultural Translation into Brazilian Portuguese and Validation of the Oral Anticoagulation Knowledge Tool (AKT-Br).

INTRODUCTION: Oral anticoagulants are the treatment of choice for diverse types of coagulation disorders. Warfarin is widely used by the Brazilian population, possibly due to its lower cost than other oral anticoagulants. However, it has a high risk of serious adverse effects if used incorrectly. The Anticoagulation Knowledge Tool (AKT) can assess a patient's knowledge about her/his oral anticoagulant therapy and can assist health professionals in identifying patients with difficulties in adherence. This study aimed to translate, culturally adapt, and validate the AKT into Brazilian Portuguese. METHODS: After a standard forward-backward procedure to translate the AKT into Brazilian Portuguese (AKT-Br), a version of the instrument was applied in three groups (patients, pharmacists, and the general population). The reliability of the AKT-Br was tested using an internal consistency measure and test-retest. The validity of the instrument was confirmed with data from the contrasted groups. All statistical analyses were performed with RStudio. RESULTS: The median scores obtained with the AKT-Br were 29.0, 17.0, and 7.5 for pharmacists, patients, and the general population, respectively (maximum score of 35 points). There was moderate internal consistency for the instrument and test-retest reliability was satisfactory. Analysis of variance for validity of the groups revealed a significant relationship between the total score and the evaluated groups. CONCLUSION: The ATK-Br is a reliable and valid tool to assess knowledge about oral anticoagulants. AKT-Br can be used in clinical practice as an auxiliary tool to improve patient care through personalised educational interventions.

Publication speed in pharmacy practice journals: A comparative analysis.

BACKGROUND: Scholarly publishing system relies on external peer review. However, the duration of publication process is a major concern for authors and funding bodies. OBJECTIVE: To evaluate the duration of the publication process in pharmacy practice journals compared with other biomedical journals indexed in PubMed. METHODS: All the articles published from 2009 to 2018 by the 33 pharmacy practice journals identified in Mendes et al. study and indexed in PubMed were gathered as study group. A comparison group was created through a random selection of 3000 PubMed PMIDs for each year of study period. Articles with publication dates outside the study period were excluded. Metadata of both groups of articles were imported from PubMed. The duration of editorial process was calculated with three periods: acceptance lag (days between 'submission date' and 'acceptance date'), lead lag (days between 'acceptance date' and 'online publication date'), and indexing lag (days between 'online publication date' and 'Entry date'). Null hypothesis significance tests and effect size measures were used to compare these periods between both groups. RESULTS: The 33 pharmacy practice journals published 26,256 articles between 2009 and 2018. Comparison group random selection process resulted in a pool of 23,803 articles published in 5,622 different journals. Acceptance lag was 105 days (IQR 57-173) for pharmacy practice journals and 97 days (IQR 56-155) for the comparison group with a null effect difference (Cohen's d 0.081). Lead lag was 13 (IQR 6-35) and 23 days (IQR 9-45) for pharmacy practice and comparison journals, respectively, which resulted in a small effect. Indexing lag was 5 days (IQR 2-46) and 4 days (IQR 2-12) for pharmacy practice and control journals, which also resulted in a small effect. Slight positive time trend was found in pharmacy practice acceptance lag, while slight negative trends were found for lead and indexing lags for both groups. CONCLUSIONS: Publication process duration of pharmacy practice journals is similar to a general random sample of articles from all disciplines.

Safety and Efficacy of Oral Anticoagulants Therapies in Patients With Atrial Fibrillation Undergoing Percutaneous Coronary Intervention: A Network Meta-Analysis.

BACKGROUND: Different antithrombotic treatments, from vitamin K antagonists to direct oral anticoagulants (DOACs), are available to reduce ischemic risks in patients with atrial fibrillation (AF) after percutaneous coronary intervention (PCI). Objective: To synthetize evidence about the benefit-risk ratio of antithrombotic treatments and their combinations in patients with AF and PCI. METHODS: A network meta-analysis and a stochastic multicriteria acceptability analysis (SMAA) were performed including randomized controlled trials (RCT) that evaluate antithrombotic treatments in adults with AF and PCI. Searches were conducted in PubMed and Scopus (updated November-2019). Outcomes compared included bleeding, stroke, and death (Prospero registration: CRD42019146813). RESULTS: Five RCTs were included (11 532 patients). Vitamin K antagonists + dual antiplatelet therapy was associated with major bleeding (odds ratio: 0.52 [95% CI: 0.32-0.86]) compared to DOAC + P2Y12. No statistical differences were found among DOAC regimens for the main outcomes, including bleeding, stroke, and death. Surface under the cumulative ranking curve analysis (SUCRA) and SMAA demonstrated edoxaban 60 mg + P2Y12 inhibitor as the worst option (28%). Apixaban 5 mg + P2Y12 inhibitor was the safest alternative (63%) in all scenarios. CONCLUSIONS: Insufficient evidence on the clinical superiority among anticoagulant regimens exists, although apixaban slightly stands out. Edoxaban was associated with more adverse events. To strength this evidence, well-designed, low risk of bias clinical trials are needed. Cost-minimization analyses are required to provide further information for clinical decision-making.

Impact of Pharmacist-led Discharge Counseling on Hospital Readmission and Emergency Department Visits: A Systematic Review and Meta-analysis.

BACKGROUND: Transitions of care can contribute to medication errors and other adverse drug events. PURPOSE: The aim of this study was to evaluate the impact of pharmacist-led discharge counseling on hospital readmission and emergency department visits through a systematic review and meta-analysis. EDATA SOURCES: Lectronic searches were performed in PubMed, Scopus, and DOAJ (Directory of Open Access Journals), along with a manual search (July 2017). PROSPERO registration no. CRD42017068444. STUDY SELECTION: Two independent reviewers performed all the steps of the systematic review process (screening of titles and abstracts, full-text appraisal, data extraction, and quality assessment), with contributions from a third researcher. We included randomized controlled trials (RCTs) reporting data on pharmacist-led discharge counseling. DATA EXTRACTION: Primary extracted outcomes were emergency department visits and hospital readmission rates. DATA SYNTHESIS: Meta-analyses of intervention versus usual care for hospital readmission and emergency department visit rates were performed using the inverse variance method. Results are reported as risk ratios (RRs) with 95% confidence intervals (CIs). Prediction intervals (PIs) were also calculated. Sensitivity and subgroup analyses were performed. A total of 21 RCTs were included in the qualitative synthesis and 18 in the meta-analyses (n = 7,244 patients). The original meta-analysis revealed a significant difference in the impact between pharmacist-led discharge counseling and usual care on overall hospital readmission (RR = 0.864 [95% CI 0.763-0.997], P = .020) and emergency department (RR = 0.697 [95% CI 0.535-0.907], P = .007) visits. However, the small number of included studies, the high heterogeneity among trials (I2 between 40% and 60%), and the wide PIs (hospital readmission: PI 0.542-1.186; emergency department visits: PI 0.027-1.367) prevented drawing further conclusions. CONCLUSIONS: Insufficient evidence exists regarding the effect of pharmacist-led discharge counseling on hospital readmission and emergency department visits. Further well-designed clinical trials with defined core outcome sets are needed.

Pharmacotherapy problems in cardiology patients 30 days post discharge from a tertiary hospital in Brazil: a randomized controlled trial.

OBJECTIVES: This is a randomized controlled trial that aims to evaluate the impact of pharmacist-led discharge counseling on reducing pharmacotherapy problems in the 30-day postdischarge period of cardiology patients from a tertiary hospital in Brazil. METHODS: At discharge, two cardiovascular pharmacy residents performed a medication counseling session with the intervention group, and the follow-up was performed by telephone (3 and 15 days after discharge). The number of pharmacotherapy problems was evaluated during a pharmacist-led ambulatory consultation 30 days after discharge. RESULTS: A total of 66 and 67 patients were randomized to the intervention and control groups, respectively, but only 51 patients were analyzed in each group, all with similar baseline characteristics. The intervention group had significantly fewer pharmacotherapy problems compared to the control (p<0.001), and 100% of the patients had at least one problem. We observed five problems significantly more frequently in the control group: "incorrect time of taking" (p=0.003), "use higher dose of medication" (p=0.007), "use lower dose of medication" (p=0.014), "restart discontinued medication" (p=0.011), and "underdosing prescription" (p=0.009). Simvastatin, enalapril, carvedilol, and atorvastatin were the medications more associated with pharmacotherapy problems. CONCLUSIONS: We concluded that pharmacist-led discharge counseling should be an indispensable service, as patients exhibited less pharmacotherapy problems in the 30-day postdischarge period, especially related to drug administration and adherence.

Description of network meta-analysis geometry: A metrics design study.

BACKGROUND: The conduction and report of network meta-analysis (NMA), including the presentation of the network-plot, should be transparent. We aimed to propose metrics adapted from graph theory and social network-analysis literature to numerically describe NMA geometry. METHODS: A previous systematic review of NMAs of pharmacological interventions was performed. Data on the graph's presentation were collected. Network-plots were reproduced using Gephi 0.9.1. Eleven geometric metrics were tested. The Spearman test for non-parametric correlation analyses and the Bland-Altman and Lin's Concordance tests were performed (IBM SPSS Statistics 24.0). RESULTS: From the 477 identified NMAs only 167 graphs could be reproduced because they provided enough information on the plot characteristics. The median nodes and edges were 8 (IQR 6-11) and 10 (IQR 6-16), respectively, with 22 included studies (IQR 13-35). Metrics such as density (median 0.39, ranged 0.07-1.00), median thickness (2.0, IQR 1.0-3.0), percentages of common comparators (median 68%), and strong edges (median 53%) were found to contribute to the description of NMA geometry. Mean thickness, average weighted degree and average path length produced similar results than other metrics, but they can lead to misleading conclusions. CONCLUSIONS: We suggest the incorporation of seven simple metrics to report NMA geometry. Editors and peer-reviews should ensure that guidelines for NMA report are strictly followed before publication.

Mapping the characteristics of network meta-analyses on drug therapy: A systematic review.

BACKGROUND: Network meta-analysis (NMA) is a new tool developed to overcome some limitations of pairwise meta-analyses. NMAs provide evidence on more than two comparators simultaneously. This study aimed to map the characteristics of the published NMAs on drug therapy comparisons. METHODS: A systematic review of NMAs comparing pharmacological interventions was performed. Searches in Medline (PubMed) and Scopus along with manual searches were conducted. The main characteristics of NMAs were systematically collected: publication metadata, criteria for drug inclusion, statistical methods used, and elements reported. A methodological quality score with 25 key elements was created and applied to the included NMAs. To identify potential trends, the median of the publication year distribution was used as a cut-off. RESULTS: The study identified 365 NMAs published from 2003 to 2016 in more than 30 countries. Randomised controlled trials were the primary source of data, with only 5% including observational studies, and 230 NMAs used a placebo as a comparator. Less than 15% of NMAs were registered in PROSPERO or a similar system. One third of studies followed PRISMA and less than 9% Cochrane recommendations. Around 30% presented full-search strategies of the systematic review, and 146 NMAs stated the selection criteria for drug inclusion. Over 75% of NMAs presented network plots, but only half described their geometry. Statistical parameters (model fit, inconsistency, convergence) were properly reported by one third of NMAs. Although 216 studies exhibited supplemental material, no data set of primary studies was available. The methodological quality score (mean 13·9; SD 3·8) presented a slightly positive trend over the years. CONCLUSION: The map of the published NMAs emphasises the potential of this tool to gather evidence in healthcare, but it also identified some weaknesses, especially in the report, which limits its transparency and reproducibility.

Impact of discharge medication counseling in the cardiology unit of a tertiary hospital in Brazil: A randomized controlled trial.

OBJECTIVES: This study aimed to evaluate the impact of pharmacist-provided discharge counseling on mortality rate, hospital readmissions, emergency department visits, and medication adherence at 30 days post discharge. METHODS: This randomized controlled trial was approved by the local ethics committee and included patients aged 18 years or older admitted to the cardiology ward of a Brazilian tertiary hospital. The intervention group received a pharmacist-led medication counseling session at discharge and a telephone follow-up three and 15 days after discharge. The outcomes included the number of deaths, hospital readmissions, emergency department visits, and medication adherence. All outcomes were evaluated during a pharmacist-led ambulatory consultation performed 30 days after discharge. RESULTS: Of 133 patients, 104 were included in the analysis (51 and 53 in the intervention and control groups, respectively). The intervention group had a lower overall readmission rate, number of emergency department visits, and mortality rate, but the differences were not statistically significant (p>0.05). However, the intervention group had a significantly lower readmission rate related to heart disease (0% vs. 11.3%, p=0.027), despite the small sample size. Furthermore, medication counseling contributed significantly to improved medication adherence according to three different tools (p<0.05). CONCLUSIONS: Pharmacist-provided discharge medication counseling resulted in better medication adherence scores and a lower incidence of cardiovascular-associated hospital readmissions, thus representing a useful service for cardiology patients.

Pharmacist-led discharge medication counselling: A scoping review.

RATIONALE, AIMS, AND OBJECTIVES: Discharge medication counselling has produced improved quality of care and health outcomes, especially by reducing medication errors and readmission rates, and improving medication adherence. However, no studies have assembled an evidence-based discharge counselling process for clinical pharmacists. Thus, the present study aims to map the components of the pharmacist-led discharge medication counselling process. METHODS: We performed a scoping review by searching electronic databases (Pubmed, Scopus, and DOAJ) and conducting a manual search to identify studies published up to July 2017. Studies that addressed pharmacist-led discharge medication counselling, regardless of the population, clinical conditions, and outcomes evaluated, were included. RESULTS: A total of 1563 studies were retrieved, with 75 matching the inclusion criteria. Thirty-two different components were identified, and the most prevalent were the indication of the medications and adverse drug reactions, which were reported in more than 50% of the studies. The components were reported similarly by studies from the USA and the rest of the world, and over the years. However, 2 differences were identified: the use of a dosage schedule, which was more frequent in studies published in 2011 or before and in studies outside the USA; and the teach-back technique, which was used more frequently in the USA. Poor quality reporting was also observed, especially regarding the duration of the counselling, the number of patients, and the medical condition. CONCLUSION: Mapping the components of the pharmacist-led discharge counselling studies through a scoping review allowed us to reveal how this service is performed around the world. Wide variability in this process and poor reporting were identified. Future studies are needed to define the core outcome set of this clinical pharmacy service to allow the generation of robust evidence and reproducibility in clinical practice.

Antioxidant effects of vitamins in type 2 diabetes: a meta-analysis of randomized controlled trials.

BACKGROUND: Vitamins are essential micronutrients with antioxidant potential that may provide a complementary treatment for patients with chronic diseases. Our aim was to assess the effect of vitamin supplementation on the antioxidant status and glycemic index of type 2 diabetes mellitus patients. METHODS: We performed a systematic review with meta-analyses. Electronic searches were conducted in PubMed, Scopus, and Web of Science (December 2017). Randomized controlled trials evaluating the effect of any vitamin or vitamin complex supplementation on antioxidant status as primary outcome were included. The outcomes considered were: reduction of malondialdehyde (MDA); augmentation of glutathione peroxidase (GPx); changes in total antioxidant capacity (TAC), enhance in superoxide dismutase enzyme-SOD, and thiobarbituric acid reactive substances (TBARS). Outcomes of glycemic control were also evaluated. Pairwise meta-analyses were performed using software Review Manager 5.3. RESULTS: Thirty trials fulfilled the inclusion criteria, but only 12 could be included in the meta-analyses of antioxidant outcomes. The most commonly studied vitamins were B, C, D and E. Vitamin E was related to significant reduction of blood glucose as well as glycated hemoglobin compared to placebo, while both vitamins C and E were mainly associated with reducing MDA and TBARS and elevating GPx, SOD and TAC, compared to placebo. However, outcome reports in this field are still inconsistent (e.g. because of a lack of standard measures). CONCLUSIONS: Supplementation of vitamin E may be a valuable strategy for controlling diabetes complications and enhancing antioxidant capacity. The effects of other micronutrients should be further investigated in larger and well-designed trials to properly place these complementary therapies in clinical practice.

Impact of discharge medication counseling in the cardiology unit of a tertiary hospital in Brazil: A randomized controlled trial

OBJECTIVES: This study aimed to evaluate the impact of pharmacist-provided discharge counseling on mortality rate, hospital readmissions, emergency department visits, and medication adherence at 30 days post discharge. METHODS: This randomized controlled trial was approved by the local ethics committee and included patients aged 18 years or older admitted to the cardiology ward of a Brazilian tertiary hospital. The intervention group received a pharmacist-led medication counseling session at discharge and a telephone follow-up three and 15 days after discharge. The outcomes included the number of deaths, hospital readmissions, emergency department visits, and medication adherence. All outcomes were evaluated during a pharmacist-led ambulatory consultation performed 30 days after discharge. RESULTS: Of 133 patients, 104 were included in the analysis (51 and 53 in the intervention and control groups, respectively). The intervention group had a lower overall readmission rate, number of emergency department visits, and mortality rate, but the differences were not statistically significant (p>0.05). However, the intervention group had a significantly lower readmission rate related to heart disease (0% vs. 11.3%, p=0.027), despite the small sample size. Furthermore, medication counseling contributed significantly to improved medication adherence according to three different tools (p<0.05). CONCLUSIONS: Pharmacist-provided discharge medication counseling resulted in better medication adherence scores and a lower incidence of cardiovascular-associated hospital readmissions, thus representing a useful service for cardiology patients.