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Notification of international normalized ratio test in atrial fibrillation patients treated with warfarin via short message service: Study protocol for a randomized controlled trial.

ABSTRACT: Atrial Fibrillation (AF) is the most common abnormal heart rhythm. AF patients usually use warfarin therapy. Safety and efficacy of warfarin are dependent on maintaining the International Normalized Ratio (INR) within the therapeutic range.We will use a Short Message Service (SMS) to evaluate the effect of a reminder on carrying out the INR laboratory test in a timely manner.This study (a Randomized Controlled Trial) will be done in Loghman hospital Tehran, Iran. Convenience sampling will be done and 400 AF patients that have inclusion criteria will be randomized equally to an intervention or control group. Patients in the intervention group will receive an SMS that will remind them of the INR test date. The SMS will be sent at 6 PM on the day before and 8 AM on the scheduled date but the patients of the control group will receive usual care without any SMS reminders. We will evaluate the effect of reminders on carrying out the INR test in a timely manner and maintaining the INR in the therapeutic range. Patients' follow-up will be done via telephone conversation to identify thromboembolic events, bleeding and mortality. The data will be analyzed by IBM SPSS version 24. We will use independent samples t-test or Mann-Whitney and Chi-square tests for the analyses of outcomes.This protocol describes the randomized control trial to study the effects of the SMS reminder system on adherence to the timing of INR test in AF patients treated with warfarin. The research will also form the basis for future decision support systems for monitoring of patients who receive oral anticoagulants.Iranian Registry of Clinical Trials (http://www.irct.ir) was used to register the trial and IRCT ID was IRCT2016052528070N1.This research was supported by Mashhad University of Medical Sciences.

SUBMITTER: Sheibani R

PROVIDER: S-EPMC5586986 | biostudies-literature | 2017 Jul

REPOSITORIES: biostudies-literature

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Notification of international normalized ratio test in atrial fibrillation patients treated with warfarin via short message service: Study protocol for a randomized controlled trial.

Sheibani Reza R Sheibani Mehdi M Hejazi Yamin Y Eslami Saeid S

Electronic physician 20170725 7

<h4>Background</h4>Atrial Fibrillation (AF) is the most common abnormal heart rhythm. AF patients usually use warfarin therapy. Safety and efficacy of warfarin are dependent on maintaining the International Normalized Ratio (INR) within the therapeutic range.<h4>Objective</h4>We will use a Short Message Service (SMS) to evaluate the effect of a reminder on carrying out the INR laboratory test in a timely manner.<h4>Methods</h4>This study (a Randomized Controlled Trial) will be done in Loghman ho ...[more]

PMID: 28894528

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Project description:BackgroundAnticoagulation management is difficult in chronic kidney disease, with frequent supratherapeutic international normalized ratios (INRs ≥ 4) increasing hemorrhagic risk. We evaluated whether the interaction of INR and lower estimated glomerular filtration rate (eGFR) increases hemorrhage risk and whether patients with lower eGFRs experience slower anticoagulation reversal.Study designProspective cohort study.Setting & participantsWarfarin pharmacogenetics cohort (1,273 long-term warfarin users); warfarin reversal cohort (74 warfarin users admitted with INRs ≥ 4).PredictoreGFR, INR as time-dependent covariate, and their interaction in the pharmacogenetics cohort; eGFR in the reversal cohort.Outcomes & measurementsIn the pharmacogenetics cohort, hemorrhagic (serious, life-threatening, and fatal bleeding) risk was assessed using proportional hazards regression. In the reversal cohort, anticoagulation reversal was assessed from changes in INR, warfarin and metabolite concentrations, clotting factors (II, VII, IX, and X), and PIVKA-II (protein induced by vitamin K absence or antagonist II) levels at presentation and after reversal, using linear regression and path analysis.ResultsIn the pharmacogenetics cohort, 454 (35.7%) had eGFRs < 60 mL/min/1.73 m(2). There were 137 hemorrhages in 119 patients over 1,802 person-years of follow-up (incidence rate, 7.6 [95% CI, 6.4-8.9]/100 person-years). Patients with lower eGFRs had a higher frequency of INR ≥ 4 (P<0.001). Risk of hemorrhage was affected significantly by eGFR-INR interaction. At INR<4, there was no difference in hemorrhage risk by eGFR (all P ≥ 0.4). At INR≥4, patients with eGFRs of 30 to 44 and < 30 mL/min/1.73 m(2) had 2.2-fold (95% CI, 0.8-6.1; P=0.1) and 5.8-fold (95% CI, 2.9-11.4; P<0.001) higher hemorrhage risks, respectively, versus those with eGFRs ≥ 60 mL/min/1.73 m(2). In the reversal cohort, 35 (47%) had eGFRs < 45 mL/min/1.73 m(2). Patients with eGFRs < 45 mL/min/1.73 m(2) experienced slower anticoagulation reversal as assessed by INR (P=0.04) and PIVKA-II level (P=0.008) than those with eGFRs ≥ 45 mL/min/1.73 m(2).LimitationsLimited sample size in the reversal cohort, unavailability of antibiotic use and urine albumin data.ConclusionsPatients with lower eGFRs have differentially higher hemorrhage risk at INR ≥ 4. Moreover, because the INR reversal rate is slower, hemorrhage risk is prolonged.

Project description:BackgroundAlthough warfarin has been extensively studied in clinical trials, little is known about rates of hemorrhage attributable to its use in routine clinical practice. Our objective was to examine incident hemorrhagic events in a large population-based cohort of patients with atrial fibrillation who were starting treatment with warfarin.MethodsWe conducted a population-based cohort study involving residents of Ontario (age ≥ 66 yr) with atrial fibrillation who started taking warfarin between Apr. 1, 1997, and Mar. 31, 2008. We defined a major hemorrhage as any visit to hospital for hemorrage. We determined crude rates of hemorrhage during warfarin treatment, overall and stratified by CHADS(2) score (congestive heart failure, hypertension, age ≥ 75 yr, diabetes mellitus and prior stroke, transient ischemic attack or thromboembolism).ResultsWe included 125 195 patients with atrial fibrillation who started treatment with warfarin during the study period. Overall, the rate of hemorrhage was 3.8% (95% confidence interval [CI] 3.8%-3.9%) per person-year. The risk of major hemorrhage was highest during the first 30 days of treatment. During this period, rates of hemorrhage were 11.8% (95% CI 11.1%-12.5%) per person-year in all patients and 16.7% (95% CI 14.3%-19.4%) per person-year among patients with a CHADS(2) scores of 4 or greater. Over the 5-year follow-up, 10 840 patients (8.7%) visited the hospital for hemorrhage; of these patients, 1963 (18.1%) died in hospital or within 7 days of being discharged.InterpretationIn this large cohort of older patients with atrial fibrillation, we found that rates of hemorrhage are highest within the first 30 days of warfarin therapy. These rates are considerably higher than the rates of 1%-3% reported in randomized controlled trials of warfarin therapy. Our study provides timely estimates of warfarin-related adverse events that may be useful to clinicians, patients and policy-makers as new options for treatment become available.

Project description:BackgroundCurrently, there is a lack of sepsis screening tools that can be widely used worldwide. Pulmonary sepsis can be of sufficient concern to physicians due to their noticeable symptoms, which usually rely less on screening tools.AimTo investigate the efficiency of the international normalized ratio (INR) for the early rapid recognition of adult nonpulmonary infectious sepsis.MethodsThis is a prospective observational study. A total of 108 sepsis patients and 106 nonsepsis patients were enrolled according to relevant inclusion and exclusion criteria. Commonly used clinical indicators, such as white blood cell, neutrophil count, lymphocyte count, neutrophil-lymphocyte count ratio (NLCR), platelets (PLT), prothrombin time, INR, activated partial thromboplastin time, and quick Sequential "Sepsis-related" Organ Failure Assessment (qSOFA) scores were recorded within 24 h after admission. The diagnostic performances of these clinical indicators were analyzed and compared through multivariate logistic regression analysis, Spearman correlation, and receiver operating characteristic curve analysis.ResultsThe INR value of the sepsis group was significantly higher than that of the nonsepsis group. INR has superior diagnostic efficacy for sepsis, with an area under the curve value of 0.918, when those preexisting diseases which significantly affect coagulation function were excluded. The diagnostic efficacy of the INR was more significant than that of NLCR, PLT, and qSOFA (P < 0.05). Moreover, INR levels of 1.17, 1.20, and 1.22 could be used to categorize the relative risk of nonpulmonary infections sepsis into three categories: low, medium and high risk, respectively.ConclusionThe INR is a promising and easily available biomarker for diagnosis, and it can be used as one of the indicators for early screening of adult nonpulmonary infectious sepsis. When its value is higher than the optimal cutoff value (1.22), high vigilance is required for adult nonpulmonary infectious sepsis.

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Notification of international normalized ratio test in atrial fibrillation patients treated with warfarin via short message service: Study protocol for a randomized controlled trial.

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Notification of international normalized ratio test in atrial fibrillation patients treated with warfarin via short message service: Study protocol for a randomized controlled trial.

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