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Online KidClot education for patients and families initiating warfarin therapy: The eKITE study
Abstract
Anticoagulation with Vitamin K antagonists (VKA) has always posed challenges in terms of monitoring requirements. These challenges were further exacerbated in the setting of the COVID-19 pandemic, with limited access to and/or avoidance of laboratory testing. The importance of utilizing point of care (POC) health technology for individualized patient management is salient. The foundation of effective home INR monitoring is establishing patient knowledge about their therapy and INR testing proficiency. The eKITE series was developed to support patients in establishing foundational knowledge required for VKA (warfarin) management and INR monitoring. The primary objectives were to evaluate eKITE, a patient-oriented innovative online education program for warfarin therapy, participant learning stress, and patient preference for online learning. This multi-center prospective study provided patients access to warfarin online education. Participants were required to complete written quizzes assessing warfarin knowledge of key concepts proficiency and identifying knowledge deficits. Patient preference, evaluating calm (lack of anxiety) while learning, and an INR on a home meter was completed. Participants performed INR tests at home and reported INRs by telephone. The analysis included 144 children and caregivers enrolled at five US and CDN sites. Most indications for anticoagulation were cardiac (congenital or acquired heart disease) with varied INR target ranges. Mean knowledge scores for warfarin and INR self-testing modules were 97%, with low anxiety with TTR of 84%. Patient preferred online learning. eKITE is an effective teaching modality for warfarin/home INR monitoring with safe INR testing and warfarin management that is appropriate for pediatrics and adults alike.
Prologue
The whir in the hallways is deafening. Lights bright, alarms are ringing in a chorus of unsynchronized beeps and screeches. It has been more than a week since I have slept. Snuggled beside me is my precious child, whining and equally irritated with the asynchronous symphony, further compounded by anxiety, procedures, and pain. The sun has broken.
The staff smiles are welcoming and incessant, as one after one, they approach hurried, urgent, assiduous, their need to coach me for our upcoming departure to the warmth of home. Each provides essential information that I will require to keep my child, my treasure, safe and healthy. Yet, my eyes are heavy, blurred, and my brain foggy, trapped in a dark heavy cloud. How am I to follow? Comprehend? and retain anything? As they instruct, my precious child yearns for loving arms, compassion and love, whining, crying in disquiet. Overwhelmed does not adequately describe my ineffable exhaustion. Amidst this, how am I to learn about warfarin? Such a challenging medication, with so much to know. Concentrate, I tell myself, focus; now is my only opportunity to learn. I must be alert. It seems to be nonsensical.
... Consistent with previous research Schulman et al., 2020), they can be viable options, showing comparable effectiveness in treatment and prevention by significantly reducing the risk of thrombosis without causing major adverse events. However, VKAs, in contrast, require monitoring (Bauman et al., 2022) and pose a higher bleeding risk, as confirmed by meta-analyses (Khan et al., 2021b). Besides the observation that NOACs outperformed VKAs in fatal bleeding events, there were no significant differences identified in other outcomes across the drugs. ...
Background
Anticoagulants are the primary means for the treatment and prevention of venous thromboembolism (VTE), but their clinical standardized application still remains controversial. The present study intends to comprehensively compare the efficacy and safety of various anticoagulants in VTE.
Methods
Medline, Embase, and Cochrane Library from their inception up to August 2023 were searched to compare the efficacy and safety of various anticoagulants in VTE. We extracted data on study settings, baseline characteristics, interventions, and outcomes, applying the intention-to-treat principle. Two researchers assessed study bias using the Cochrane tool, resolving disagreements through discussion or third-party adjudication. Network meta-analyses were performed based on Bayesian generalized linear models, and a frequentist framework with multivariate random effects was used to fit the model.
Results
In terms of treatment, 58 trials with 119,417 patients proved eligible, while 125 trials with 225,414 patients were included in terms of prevention. All anticoagulants were found to reduce the recurrence or incidence of VTE compared with Placebo, of which high-level evidence indicated that direct thrombin inhibitors (TIs) and novel oral anticoagulants (NOACs) were the two most effective drugs. For treatment, low molecular weight heparin (LMWH), unfractionated heparin (UFH), and vitamin K antagonists (VKAs) significantly increased the risk of major bleeding in comparison to Placebo. For prevention, only UFH (OR 2.0, 95% CI 1.2–3.3) and NOACs (OR 1.8, 95% CI 1.2–2.6) showed significant increased risks in major bleeding. Additionally, after an exhaustive analysis of NOACs, analysis showed that apixaban (RR 0.5, 95%CI 0.17–1.46) had a superior performance in major bleeding compared to rivaroxaban (RR 3.87, 95%CI 1.48–10.09).
Conclusion
TIs and NOACs were superior in efficacy with minimal side effects, making them pivotal choices for both prevention and treatment of VTE. Clinical practitioners must carefully weigh drug characteristics, indications, and contraindications to optimize treatment outcomes.
Systematic Review Registration
https://www.crd.york.ac.uk/PROSPERO/display_record.php?RecordID=466775.
... Professional organizations widely endorse anticoagulants for preventing and treating blood clots in conditions that have a higher risk of leading to venous thromboembolism and stroke (e.g., chronic atrial fibrillation, artificial heart valves, antiphospholipid syndrome, genetic or acquired thrombophilia, cancer). 1,2 While anticoagulants may reduce morbidity and mortality in some patients, [3][4][5] they may also lead to serious adverse effects (e.g., bleeding). 6,7 The 2014 National Action Plan for Adverse Drug Event Prevention (ADE Action Plan) identified anticoagulants as a leading cause of adverse drug events. ...
Introduction
Warfarin continues to be used in children for specific indications. Children must test their blood regularly and adherence to the medication routine can be highly challenging. Warfarin nonadherence has the potential for significant complications. Blister packaging (BP) is not commonly applied to warfarin therapy due to frequent dose titrations however BP may be useful in improving adherence.
Objective
To evaluate the efficacy of BP warfarin to determine its impact on outpatient management.
Methods
Retrospective chart review of children aged from 18 months to 18 years with suboptimal adherence transitioned to BP between 2021 and 2023. Data collected included international normalized ratio (INR) reminders, missed doses, bleeding or thrombotic events, and INRs for 6 months pre-/post-BP. Time in therapeutic range (TTR) analysis as a measure of safety and efficacy was used.
Results
Eleven charts were reviewed. Mean and median age were 11 and 9 years, respectively (4 to 17 range), nine female and two male. International normalized ratio reminders required decreased 30% pre-/post-BP initiation 84 (mean 7.6, range 0 to 18/child) and 59 (mean 5.4; range 1 to 15/child), respectively. Missed doses decreased by 20% pre-/post-BP 35 (mean 3.2; range 0 to 10) and 29 (mean 2.6; range 0 to 10), respectively. The TTR increased by a median of 11.61% from pre to post. This difference was not statistically significant (P-value from Wilcoxon signed rank test: 0.1602).
Conclusion
This study demonstrates that BP is a viable option that supports warfarin management. Caregivers described BP as beneficial with a trend to increased TTR and a decrease in healthcare provider workload.
Warfarin is a commonly prescribed anticoagulant which is indicated for the management of various medical conditions. However, there are challenges associated with warfarin use, such as difficulty in achieving the target international normalized ratio (INR), serious adverse events, and drug and dietary interactions leading to poor patient compliance, which, if not addressed, increase the risk of adverse events and burden on the healthcare system. Warfarin needs regular monitoring owing to its narrow therapeutic index. Digital health may emerge as a promising avenue for warfarin management. Our objective is to review digital health's role in managing warfarin, its limitations, and future directions. Digital healthcare applications can help patients monitor warfarin, increase patient compliance, provide patient education, decrease the need for clinical visits, empower the patient’s participation in their own healthcare, and assist clinicians with decision support, thereby improving outcomes and quality of life. Therefore, this review article is aimed at clinicians, pharmacists, nurses, and researchers involved in managing warfarin. We specifically focus on recent digital technologies that have shown potential for warfarin management such as mobile applications, anticoagulation software, point-of-care and wireless INR devices, artificial intelligence and machine learning, and telehealth. Furthermore, we describe their limitations, relevance to patient care and clinical practice, and future directions.
Objective
To assess the feasibility of implementing a web-based discharge education programme for general surgery patients both prior to and after hospital discharge.
Design, setting and participants
This is a prospective, two-arm, pilot randomised controlled trial. Patients who had a general surgery procedure were recruited from a tertiary hospital between October 2020 and January 2021. Patients were randomly assigned to either the standard education or the web-based education intervention.
Intervention
The web-based education comprised of three components designed to enhance patients’ knowledge, skills and confidence to improve their engagement with self-care, and the ability to detect any postoperative issues that can arise during the postdischarge period.
Main outcomes and measures
The primary outcome was feasibility in terms of recruitment, randomisation, retention and treatment fidelity related to intervention delivery, adherence and satisfaction. Secondary outcomes were patient activation, self-care ability and unplanned healthcare utilisation.
Results
Eighty-five patients were recruited and randomised (42 control; 43 intervention). Twenty-three (27%) were lost to follow-up. All patients received their group allocation as randomised and all patients in the intervention group received the web-based education prior to discharge. Postdischarge, patients accessed the education an average of 3 times (SD 3.14), with 4 minutes (SD 16) spent on the website. 28 (97%) of the intervention patients found the content easy to understand, 25 (86%) found it useful and 24 (83%) were satisfied with its content. There was a significant association between the intervention and patient activation ( F( 1,60)=9.347, p=0.003), but not for self-care ability and unplanned healthcare utilisations.
Conclusion
This pilot study demonstrated the feasibility of implementing a web-based education programme. There was a high number of participants lost to follow-up, requiring additional attention in the design and implementation of a larger trial.
Trial registration number
ACTRN12620000389909p.
Anticoagulant treatment of pediatric central venous catheter-related venous thromboembolism (CVC-VTE) has not been specifically evaluated. In EINSTEIN-Jr, 500 children with any VTE received rivaroxaban or standard anticoagulants. A predefined analysis of the CVC-VTE cohort was performed. Children with CVC-VTE (age, birth to 17 years) were administered rivaroxaban or standard anticoagulants during the 1-month (children <2 years) or 3-month (all other children) study period. Predefined outcomes were recurrent VTE, change in thrombotic burden on repeat imaging, and bleeding. Predictors for continuation of anticoagulant therapy beyond the study period were evaluated. One hundred twenty-six children with symptomatic (n = 76, 60%) or asymptomatic (n = 50, 40%) CVC-VTE received either rivaroxaban (n = 90) or standard anticoagulants (n = 36). There was no recurrent VTE (0%; 95% confidence interval [CI], 0.0%-2.8%). Three children had the principal safety outcome: none had major bleeding and 3 children had clinically relevant nonmajor bleeding (2.4%; 95% CI, 0.7%-6.5%), all in the rivaroxaban arm. Complete or partial vein recanalization occurred in 57 (55%) and 38 (37%) of 103 evaluable children, respectively. Results were similar for symptomatic and asymptomatic CVC-VTE. Continuation of anticoagulant therapy beyond the study period occurred in 61 (48%) of children and was associated with residual VTE but only in children <2 years (odds ratio [OR], 20.9; P = .003) and continued CVC use (OR, 6.7; P = .002). Anticoagulant therapy appeared safe and efficacious and was associated with reduced clot burden in most children with symptomatic or asymptomatic CVC-VTE. Residual VTE and continued CVC use were associated with extended anticoagulation. This trial was registered at www.clinicaltrials.gov as #NCT02234843.
Background
Little is known about how to develop and deliver storytelling as an intervention to support those managing chronic illnesses. This scoping review aims to describe the core elements of storytelling interventions in order to help facilitate its implementation.
Methods
A scoping review was conducted in seven databases for articles published up to May 2014 to identify interventions that describe in detail how storytelling was used to support people in disease self-management interventions.
Results
Ten articles met all inclusion criteria. Core elements consistently observed across the storytelling interventions were: reflection and interactive meaning-making of experiences; principles of informality and spontaneity; non-directional and non-hierarchical facilitation; development of group norms and conduct to create a community among participants; and both an individual and collective role for participants. Differences were also observed across interventions, such as: the conceptual frameworks that directed the design of the intervention; the type and training of facilitators; intervention duration; and how session topics were selected and stories delivered. Furthermore, evaluation of the intervention and outcome assessment varied greatly across studies.
Conclusion
The use of storytelling can be a novel intervention to enhance chronic disease self-management. The core elements identified in the review inform the development of the intervention to be more patient-centred by guiding participants to take ownership of and lead the intervention, which differs significantly from traditional support groups. Storytelling has the potential to provide patients with a more active role in their health care by identifying their specific needs as well as gaps in knowledge and skills, while allowing them to form strong bonds with peers who share similar disease-related experiences. However, measures of impact differed across interventions given the variation in chronic conditions. Our findings can guide future development and implementations of storytelling interventions.
The objective of this study was to investigate the effectiveness of brain-based learning (BBL) and animated cartoons on video compact discs (VCDs) in enhancing the healthy habits of school children. A representative sample of 1085 school children in the first through the third grades at 16 schools was selected by multistage random sampling. Knowledge of healthy habits and self-reported adoption of practices were assessed by a questionnaire. BBL and VCD, either combined or as single-intervention techniques, led to improved knowledge and practice of healthy behavior, whereas conventional teaching did not. As a single-intervention technique, BBL on its own led to a greater improvement in healthy practices than VCD, but the addition of BBL to VCD made no difference, and there was no difference between BBL and VCD in terms of improvements in knowledge. In conclusion, both BBL and VCD are effective, but VCD requires fewer resources. Recommendations are made for further research.
Point-of-care INR (POC INR) meters can provide a safe and effective method for monitoring oral vitamin K antagonists (VKAs) in children. Stollery Children's Hospital has a large POC INR meter loan program for children requiring oral VKAs. Our protocol requires that POC INR results be compared to the standard laboratory INR for each child on several consecutive tests to ensure accuracy of CoaguChek XS (Roche Diagnostics, Basel Switzerland) meter. It was the objective of the study to determine the accuracy of the CoaguChek XS by comparing whole blood INR results from the CoaguChek XS to plasma INR results from the standard laboratory in children. POC INR meter validations were performed on plasma samples from two time points from 62 children receiving warfarin by drawing a venous blood sample for laboratory prothrombin (PT)-INR measurements and simultaneous INR determinations using the POC-INR meter. Agreement between CoaguChek XS INR and laboratory INR was assessed using Bland-Altman plots. Bland-Altman's 95% limits of agreement were 0.11 (-0.20; 0.42) and 0.13 (-0.22; 0.48) at the two time points, respectively. In conclusion, the CoaguChek XS meter appraisal generates an accurate and precise INR measure in children when compared to laboratory INR test results.
Medical e-learning technology is widely employed to create an online platform for patients and healthcare providers alike. However, there are few studies that have investigated the reasons why some users reject e-learning technology usage after their initial experience. This study was conducted with the aim to better understand the factors leading to patients' continued usage of e-learning technologies. The theoretical foundation was based on the expectation-confirmation theory (ECT). The questionnaire survey was conducted during a two-month period and covered a total sample of 281 outpatients in a regional-teaching hospital. We found that the intention to continue e-learning usage was significantly related to patients' education level, expectation, perceived performance, confirmation and satisfaction. The use of this ECT model may provide administrators in the healthcare industry insights into the implementation of e-learning technologies. This research also opens up a new direction and enhances the completeness of related researches in the fields of medical informatics and health education.
Oral anticoagulant therapy has been shown to be effective for several indications. The optimal intensity of anticoagulation for each indication, however, is largely unknown. To determine this optimal intensity, randomised clinical trials are conducted in which two target levels of anticoagulation are compared. This approach is inefficient, since the choice of the target levels will be arbitrary. Moreover, the achieved intensity is not taken into account.
We propose a method to determine the optimal achieved intensity of anticoagulation. This method can be applied within a clinical trial as an “efficacy-analysis”, but also on data gathered in day-to-day patient care.
In this method, INR-specific incidence rates of events, either thromboembolic or hemorrhagic, are calculated. The numerator of the incidence rate is based on data on the INR at the time of the event. The denominator consists of the person-time at each INR value, summed over all patients, and is calculated from all INR measurements of all patients during the follow-up interval. This INR-specific person-time is calculated with the assumption of a linear increase or decrease between two consecutive INR determinations. Since the incidence rates may be substratified on covariates, efficient assessment of the effects of other factors (e.g. age, sex, comedication) by multivariate regression analysis becomes possible.
This method allows the determination of the optimal pharmacological effects of anticoagulation, which can form a rational starting point for choosing the target levels in subsequent clinical trials.
Inadequate functional health literacy is common, but its impact on patients with chronic diseases is not well described.
To examine among patients with hypertension or diabetes the relationship between their functional health literacy level and their knowledge of their chronic disease and treatment.
We conducted a cross-sectional survey of patients with hypertension and diabetes presenting to the general medicine clinics at 2 urban public hospitals. Literacy was measured by the Test of Functional Health Literacy in Adults. Knowledge of their illness was assessed in patients with diabetes or hypertension using 21 hypertension and 10 diabetes questions based on key elements in educational materials used in our clinics.
A total of 402 patients with hypertension and 114 patients with diabetes were enrolled. Mean (+/- SD) knowledge scores for patients with hypertension with inadequate (n = 189), marginal (n = 49), or adequate (n = 155) literacy were 13.2 +/- 3.1, 15.3 +/- 2.2, and 16.5 +/- 2.3, respectively (range, 4-20; P < .001). A total of 92% of patients with hypertension and adequate literacy levels knew that a blood pressure reading of 160/100 mm Hg was high compared with 55% of those in the lowest reading level (P < .001). Mean (+/- SD) knowledge scores for patients with diabetes with inadequate (n = 50), marginal (n = 13), or adequate (n = 51) literacy were 5.8 +/- 2.1, 6.8 +/- 1.9, and 8.1 +/- 1.6, respectively (range, 1-10; P < .001). A total of 94% of patients with diabetes and adequate functional health literacy knew the symptoms of hypoglycemia compared with 50% of those with inadequate literacy (P < .001).
Inadequate functional health literacy poses a major barrier to educating patients with chronic diseases, and current efforts to overcome this appear unsuccessful.
To determine the relationship of literacy to asthma knowledge and ability to use a metered-dose inhaler (MDI) among patients with asthma.
Cross-sectional survey.
Emergency department and asthma clinic at an urban public hospital.
Convenience sample of 273 patients presenting to the emergency department for an asthma exacerbation and 210 patients presenting to a specialized asthma clinic for routine care.
Measurement of literacy with the Rapid Estimate of Adult Literacy in Medicine, asthma knowledge (20 question oral test), and demonstration of MDI technique (six-item assessment).
Only 27% of patients read at the high-school level, although two thirds reported being high-school graduates; 33% read at the seventh- to eighth-grade level, 27% at the fourth- to sixth-grade level, and 13% at or below the third-grade level. Mean asthma knowledge scores (+/-SD) were directly related to reading levels: 15.1+/-2.5, 13.9+/-2.5, 13.4+/-2.8, 11.9+/-2.5, respectively (p < 0.01). Patient reading level was the strongest predictor of asthma knowledge score in multivariate analysis. Poor MDI technique (< or =3 correct steps) was found in 89% of patients reading at less than the third-grade level compared with 48% of patients reading at the high-school level. In multivariate regression analyses, reading level was the strongest predictor of MDI technique.
Inadequate literacy was common and strongly correlated with poorer knowledge of asthma and improper MDI use.
A whole blood prothrombin time/international normalized ratio (PT/INR) monitor (CoaguChek, Roche Diagnostics Corp., Indianapolis, IN) was assessed in children for its accuracy, reliability, safety, and acceptance by health care personnel and patient's families. The PT/INR values measured by the CoaguChek monitor showed an excellent correlation with PT/INR values measured by the Hospital for Sick Children (HSC) laboratory (r = 0.96) and Hamilton Civic Hospitals Research Centre (HCHRC) laboratory (r = 0.92) in clinic patients and a close correlation with PT/INR values measured by the HSC laboratory (r = 0.76) and HCHRC laboratory (r = 0.74) in patients at home. Reduced correlation in the home setting did not adversely affect clinical management. The whole blood PT/INR monitor is safe and accurate for children requiring oral anticoagulation therapy in either the outpatient clinic or home setting.
This study analyzed whether inadequate functional health literacy is an independent risk factor for hospital admission.
We studied a prospective cohort of 3260 Medicare managed care enrollees.
Of the participants, 29.5% were hospitalized. The crude relative risk (RR) of hospitalization was higher for individuals with inadequate literacy (n = 800; RR = 1.43; 95% confidence interval [CI] = 1.24, 1.65) and marginal literacy (n = 366; RR = 1.33; 95% CI = 1.09, 1.61) than for those with adequate literacy (n = 2094). In multivariate analysis, the adjusted relative risk of hospital admission was 1.29 (95% CI = 1.07, 1.55) for individuals with inadequate literacy and 1.21 (95% CI = 0.97, 1.50) for those with marginal literacy.
Inadequate literacy was an independent risk factor for hospital admission among elderly managed care enrollees.
Children with severe hemophilia are at risk for reduced bone mineral density (BMD) because of reduced weight-bearing exercise and hepatitis C infection. Reduced bone density in childhood is a risk factor for osteoporosis in later life.
We performed a cross-sectional survey of bone density among 19 children with severe hemophilia, at the Royal Children's Hospital. Results were correlated with findings of blinded objective evaluations of the joints of the lower limb and with hepatitis C status.
The mean lumbar bone mineral apparent density for patients was reduced (0.102 g/cm3), compared with that for control subjects (0.113 g/cm3). The mean areal BMD z score was -0.92, which was significantly reduced, compared with that for control subjects. The difference in bone density was independent of body size. There was a statistically significant relationship between the lumbar BMD z scores and the maximal single joint evaluation scores, but there was no difference based on hepatitis C status.
Our results suggest that children with severe hemophilia have reduced BMD. Patients at risk are those with signs of hemophilic arthropathy. Because osteoporosis may complicate the future treatment of patients with hemophilia, screening of young patients for reduced bone density is recommended.
This article about antithrombotic therapy in children is part of the 7th American College of Chest Physicians Conference on Antithrombotic and Thrombolytic Therapy: Evidence-Based Guidelines. Grade 1 recommendations are strong and indicate that the benefits do, or do not, outweigh the risks, burden, and costs. Grade 2 suggests that individual patients' values may lead to different choices (for a full understanding of the grading see Guyatt et al, CHEST 2004; 126:179S-187S). Among the key recommendations in this article are the following. In neonates with venous thromboembolism (VTE), we suggest treatment with either unfractionated heparin or low-molecular-weight heparin (LMWH), or radiographic monitoring and anticoagulation therapy if extension occurs (Grade 2C). We suggest that clinicians not use thrombolytic therapy for treating VTE in neonates, unless there is major vessel occlusion that is causing the critical compromise of organs or limbs (Grade 2C). For children (ie, > 2 months of age) with an initial VTE, we recommend treatment with i.v. heparin or LMWH (Grade 1C+). We suggest continuing anticoagulant therapy for idiopathic thromboembolic events (TEs) for at least 6 months using vitamin K antagonists (target international normalized ratio [INR], 2.5; INR range, 2.0 to 3.0) or alternatively LMWH (Grade 2C). We suggest that clinicians not use thrombolytic therapy routinely for VTE in children (Grade 2C). For neonates and children requiring cardiac catheterization (CC) via an artery, we recommend i.v. heparin prophylaxis (Grade 1A). We suggest the use of heparin doses of 100 to 150 U/kg as a bolus and that further doses may be required in prolonged procedures (both Grade 2 B). For prophylaxis for CC, we recommend against aspirin therapy (Grade 1B). For neonates and children with peripheral arterial catheters in situ, we recommend the administration of low-dose heparin through a catheter, preferably by continuous infusion to prolong the catheter patency (Grade 1A). For children with a peripheral arterial catheter-related TE, we suggest the immediate removal of the catheter (Grade 2C). For prevention of aortic thrombosis secondary to the use of umbilical artery catheters in neonates, we suggest low-dose heparin infusion (1 to 5 U/h) (Grade 2A). In children with Kawasaki disease, we recommend therapy with aspirin in high doses initially (80 to 100 mg/kg/d during the acute phase, for up to 14 days) and then in lower doses (3 to 5 mg/kg/d for > or = 7 weeks) [Grade 1C+], as well as therapy with i.v. gammaglobulin within 10 days of the onset of symptoms (Grade 1A).
This document provides health care professionals involved in initiating and monitoring oral anticoagulation therapy with guidelines for the provision of safe and effective patient self-testing/patient self-management of oral anticoagulation.
The consensus group has critically reviewed the literature and compared the results of usual care (UC) vs. anticoagulation clinic and patient self-management/patient self-testing (PSM/PST). The education and training of patients for self-monitoring are described, together with the suitability of patients, the effect on quality of life and cost-effectiveness. The consensus agrees that patient self-testing and patient self-management are effective methods of monitoring oral anticoagulation therapy, providing outcomes at least as good as, and possibly better than, those achieved with an anticoagulation clinic. All patients must be appropriately selected and trained. Currently available self-testing/self-management devices give INR results which are comparable with those obtained in laboratory testing. The most frequent testing frequency is weekly but lower frequency of testing can be justified based on institutional or patient conditions.
The consensus agrees that there are several points in favour of PST/PSM, for example, a higher degree of medical safety, increased patient education, improved response to changes in lifestyle, increased independence for the patient and improved quality of life.
Oral anticoagulation therapy with warfarin is the mainstay of prevention and treatment of thromboembolic disease. However, it remains one of the leading causes of harmful medication errors and medication-related adverse events. The beneficial outcomes of oral anticoagulation therapy are directly dependent upon the quality of dose and anticoagulation management, but the literature is not robust with regards to what constitutes such management. This review focuses on, and attempts to define, the parameters of high-quality anticoagulation management and identifies the appropriate outcome measures constituting high-quality management. Elements discussed include the most fundamental measure, time in therapeutic range, along with other parameters including therapy initiation, time to therapeutic range, dosing management when patients are not in therapeutic range, perioperative dosing management, patient education, and other important outcome measures. Healthcare providers who manage oral anticoagulation therapy should utilize these parameters as a measure of their performance in an effort to achieve high-quality anticoagulation management.
Stories in all of their many forms, including books, plays, skits, movies, poems, and songs, appeal to individuals of all ages but especially the young. Children are easily engaged in stories, and today's generation of children, the millennium generation, demands interactive, multimedia-rich environments. Story as a teaching and learning technique is pervasive in the classroom but is infrequently used to promote health. Because of advancing technology, it is possible to create interactive digital storytelling programs that teach children health topics. Using digital storytelling in an interactive environment to promote health has not been tested, but there is empirical support for using story in health education and interactive technology to promote health. This article briefly reviews the literature and discusses how technology and storytelling can be joined to promote positive health outcomes.
Background
Recently, the randomized EINSTEIN‐Jr. study showed similar efficacy and safety for rivaroxaban and standard anticoagulation for treatment of pediatric venous thromboembolism (VTE). The rivaroxaban dosing strategy was established based on phase 1 and 2 data in children and through pharmacokinetic (PK) modeling.
Methods
Rivaroxaban treatment with tablets or the newly‐developed granules‐for‐oral suspension formulation was bodyweight‐adjusted and administered once‐daily, twice‐daily or thrice‐daily for children with bodyweights of ≥30, ≥12‐<30, and <12kg, respectively. Previously, these regimens were confirmed for children weighing ≥20kg but only predicted in those <20kg. Based on sparse blood sampling, the daily area under the plasma concentration–time curve [AUC(0‐24)ss] and trough [Ctrough,ss] and maximum [Cmax,ss] steady‐state plasma concentrations were derived using population PK modeling. Exposure‐response graphs were generated to evaluate the potential relationship of individual PK parameters with recurrent VTE, repeat imaging outcomes, and bleeding or adverse events. A taste‐and‐texture questionnaire was collected for suspension‐recipients.
Results
Of the 335 children (aged 0‐17 years) allocated to rivaroxaban, 316 (94.3%) were evaluable for PK analyses. Rivaroxaban exposures were within the adult exposure range. No clustering was observed for any of the PK parameters with efficacy, bleeding, or adverse event outcomes. Results were similar for the tablet and suspension formulation. Acceptability and palatability of the suspension were favorable.
Discussion
Based on this analysis and the recently documented similar efficacy and safety of rivaroxaban compared with standard anticoagulation, we conclude that bodyweight‐adjusted pediatric rivaroxaban regimens with either tablets or suspension are validated and provide for appropriate treatment of children with VTE.
Background:
Rivaroxaban has been shown to be efficacious for treatment of venous thromboembolism in adults, and has a reduced risk of bleeding compared with standard anticoagulants. We aimed to develop paediatric rivaroxaban regimens for the treatment of venous thromboembolism in children and adolescents.
Methods:
In this phase 2 programme, we did three studies to evaluate rivaroxaban treatment in children younger than 6 months, aged 6 months to 5 years, and aged 6-17 years. Our studies used a multicentre, single-arm design at 54 sites in Australia, Europe, Israel, Japan, and north America. We included children with objectively confirmed venous thromboembolism previously treated with low-molecular weight heparin, fondaparinux, or a vitamin K antagonist for at least 2 months or, in children who had catheter-related venous thromboembolism for at least 6 weeks. We administered rivaroxaban orally in a bodyweight-adjusted 20 mg-equivalent dose, based on physiologically-based pharmacokinetic modelling predictions and EINSTEIN-Jr phase 1 data in young adults, in either a once-daily (tablets; for those aged 6-17 years), twice-daily (in suspension; for those aged 6 months to 11 years), or three times-daily (in suspension; for those younger than 6 months) dosing regimen for 30 days (or 7 days for those younger than 6 months). The primary aim was to define rivaroxaban treatment regimens that match the target adult exposure range. The principal safety outcome was major bleeding and clinically relevant non-major bleeding. Analyses were per-protocol. The predefined efficacy outcomes were symptomatic recurrent venous thromboembolism, asymptomatic deterioration on repeat imaging at the end of the study treatment period. These trials are registered at ClinicalTrials.gov, numbers NCT02564718, NCT02309411, and NCT02234843.
Findings:
Between Feb 11, 2013, and Dec 20, 2017, we enrolled 93 children (ten children younger than 6 months; 15 children aged 6 months to 1 year; 25 children aged 2-5 years; 32 children aged 6-11 years; and 11 children aged 12-17 years) into our study. 89 (96%) children completed study treatment (30 days of treatment, or 7 days in those younger than 6 months), and 93 (100%) children received at least one dose of study treatment and were evaluable for the primary endpoints. None of the children had a major bleed, and four (4%, 95% CI 1·2-10·6) of these children had a clinically relevant non-major bleed (three children aged 12-17 years with menorrhagia and one child aged 6-11 years with gingival bleeding). We found no symptomatic recurrent venous thromboembolism in any patients (0%, 0·0-3·9). 24 (32%) of 75 patients with repeat imaging had their thrombotic burden resolved, 43 (57%) patients improved, and eight (11%) patients were unchanged. No patient deteriorated. We confirmed therapeutic rivaroxaban exposures with once-daily dosing in children with bodyweights of at least 30 kg and with twice-daily dosing in children with bodyweights of at least 20 kg and less than 30 kg. Children with low bodyweights (<20 kg, particularly <12 kg) showed low exposures so, for future studies, rivaroxaban dosages were revised for these weight categories, to match the target adult exposure range. 61 (66%) of 93 children had adverse events during the study. Pyrexia was the most common adverse event (ten [11%] events), and anaemia and neutropenia or febrile neutropenia were the most frequent grade 3 or worse events (four [4%] events each). No children died or were discontinued from rivaroxaban because of adverse events.
Interpretation:
Treatment with bodyweight-adjusted rivaroxaban appears to be safe in children. The treatment regimens that we confirmed in children with bodyweights of at least 20 kg and the revised treatment regimens that we predicted in those with bodyweights less than 20 kg will be evaluated in the EINSTEIN-Jr phase 3 trial in children with acute venous thromboembolism.
Funding:
Bayer AG, Janssen Research and Development.
Background:
Discharge education is essential for postoperative general surgery patients for their self-management of care at home post discharge. The first 30 days' post-surgery is pivotal to the post-operative recovery process as this is when most post-operative complications occur. Insufficient discharge education can compromise patients' recovery process causing postoperative complications and unplanned hospital readmissions.
Objectives:
To identify the discharge education provided to general surgery patients.
Design:
Systematic mixed studies review.
Data sources:
Literature data sources were searched from December 2017 to January 2018 using the four databases: EBSCO CINAHL Plus, EBSCO MEDLINE, Ovid EMBASE and COCHRANE Library. Searches were supplemented with hand searching of reference lists.
Review methods:
The relevance of the articles was reviewed using the inclusion and exclusion criteria; included data were extracted and presented in a summary table. Two reviewers appraised the methodological quality of the articles using the Mixed Methods Appraisal Tool. Discussions were held to examine emergent themes, quality scores of the studies, and agreement reached by consensus. Themes were derived through inductive analysis.
Results:
A total of 468 records were screened for titles and abstracts and 7 studies met the inclusion criteria. There was a mix of qualitative and quantitative studies. The majority of the included sample were patients with one quantitative study including patients' family and nurses. Discharge education was delivered at various timing and at different doses during the surgical process. Education delivered was mostly standardised and some of the discharge interventions were tailored and included a checklist for stoma care and a discharge warning tool. Four themes were identified: quality of discharge education influences its uptake, health care professionals' perceptions of their role in the delivery of discharge education to patients, patients' preferences for education delivery and patients' participation in their self-care.
Conclusions:
The quality of discharge education has an influence on patient participation in their management of care post discharge. Assessing patients' preparedness for discharge is an essential component of discharge planning process. The presentation, timing and frequency of discharge education was important in the delivery of information. Tailored education reflecting the learning needs of patients using multiple media delivered in varying doses enhanced patients' overall knowledge for successful management of recovery post discharge. The scarcity of recent literature in discharge education indicates that the quantity of evidence regarding discharge education intervention in general surgery patients is low and further work in this area needs to be undertaken.
Objective:
The objective of this study was to evaluate transition to adult care for AYAs requiring indefinite warfarin therapy within a structured self-management program.
Outcome measures:
Results were compared between Phase 1 (enrollment to patient self-management) and Phase 2 (independent warfarin management) 6months following confirmation of transition to adult care. There was no statistical difference between outcome measures except INR testing frequency, and no adverse events.
Conclusions:
This transition process resulted in successful transition as measured by TTR and other clinical end-points from pediatric to adult care. Implementing a formal transition process for young adults with chronic health conditions that considers patient preferences motivates and empowers them over time to develop autonomy with warfarin self-management, results in successful transition and warfarin management.
Background:
Patient self-management (PSM) in adults is safer and more cost effective than conventional management. Warfarin is a narrow therapeutic index drug with individual patient response to changes and frequently a long-term therapy. Children and their families are proposed to be able to effectively manage their child's warfarin therapy. Increased health related quality of life is highly associated with effective therapy in patients with chronic conditions.
Objectives:
The aim of this study is to evaluate the safety and efficacy of PSM over time including HRQOL and variables that may influence PFU success at PSM.
Patients/methods:
Children and their family units (PFUs) current performing patient self-testing/monitoring for ≥3months were enrolled in this cohort study. PFUs participated in comprehensive education on warfarin testing and management followed by an apprenticeship. Socio-demographic, clinical, and laboratory data were collected to evaluate safety and efficacy and health related quality of life. Outcomes were compared between the first 6months on PSM (phase 1) and the last 6months data collected on PSM (phase 2).
Results:
Forty-two patients performed PSM for a median of 2.7years (range: 1.1-6.2years). Time in therapeutic range was 90% and 92.9% (p=0.30) in phases 1 and 2 respectively. All measures were strongly associated with improved heath related quality of life. PFUs socio-demographic status did not influence success at PSM. All PFUs maintained warfarin knowledge and INR testing competency. Warfarin dosing decision errors median 0 (range: 0-5, p=0.73) and a median 0 (range 0-4, p=0.55) per patient in phases 1 and 2 respectively. There were no adverse hemorrhagic or thrombotic events.
Conclusions:
Empowering PFUs to self-manage warfarin results in increased knowledge and understanding of their health condition, improved commitment to their health care and adherence to medication regimens and is demonstrated to be sustainable over time.
Objective To collaborate with community members to develop tailored infographics that support comprehension of health information, engage the viewer, and may have the potential to motivate health-promoting behaviors.
Methods The authors conducted participatory design sessions with community members, who were purposively sampled and grouped by preferred language (English, Spanish), age group (18–30, 31–60, >60 years), and level of health literacy (adequate, marginal, inadequate). Research staff elicited perceived meaning of each infographic, preferences between infographics, suggestions for improvement, and whether or not the infographics would motivate health-promoting behavior. Analysis and infographic refinement were iterative and concurrent with data collection.
Results Successful designs were information-rich, supported comparison, provided context, and/or employed familiar color and symbolic analogies. Infographics that employed repeated icons to represent multiple instances of a more general class of things (e.g., apple icons to represent fruit servings) were interpreted in a rigidly literal fashion and thus were unsuitable for this community. Preliminary findings suggest that infographics may motivate health-promoting behaviors.
Discussion Infographics should be information-rich, contextualize the information for the viewer, and yield an accurate meaning even if interpreted literally.
Conclusion Carefully designed infographics can be useful tools to support comprehension and thus help patients engage with their own health data. Infographics may contribute to patients’ ability to participate in the Learning Health System through participation in the development of a robust data utility, use of clinical communication tools for health self-management, and involvement in building knowledge through patient-reported outcomes.
Cancer is one of the leading causes of death around the world. Mortality from breast cancer can be reduced if the cancer is detected early enough. It is important to find effective communication that encourages early detection of breast cancer. This study aimed to measure differences between narrative and didactic communication on breast cancer awareness, knowledge of appropriate diagnostic exams, attitude toward breast self-exam, and intention to screen for breast cancer through a breast self-exam. It further aimed to test whether any differences in outcomes were associated with the format used to deliver the communication: video or infographic. The effects of the communication strategies were tested using an experimental design with a control group and four experimental groups: narrative video, didactic video, narrative infographic, or didactic infographic. A total of 194 Italian-speaking women ages 18-30 years completed questionnaires before and after exposure. Positive increases were found for all outcome variables after exposure to any communication strategy tested. The didactic message delivered in video format had the most positive effect on awareness and knowledge, whereas the narrative video message had the most positive effect on attitude and intention. For both message types, videos had a more positive influence than infographics when communicating breast cancer information for this audience. This was the first study of message effects of breast cancer communication with Italian-speaking young women. Further research is warranted to understand how to maximize communication strategies so that they are the most effective in influencing behaviors and if these results are consistent with other linguistic populations.
Interactive whiteboards (IWB) are regarded as one of the most revolutionary instructional technologies for various educational levels. While the impacts of IWBs in classroom settings have been examined recently in a number of studies, this study not only looks at the perception but also examines the actual usage and behaviors associated with promising IWB features in practical settings. The main goal of this paper is to evaluate both teachers' perceptions and their use of IWBs. A questionnaire was developed based on an extensive literature review as well as related instructional theories and models. The questionnaire consisted of questions about demographics, usage, and teachers' perceptions related to IWBs. For this study, 174 teacher-participants, who have actively used IWBs for instruction, were selected from various educational levels (from grade 6 to 12). The results show that teachers believe that IWBs can be used for different subject domains. Also, teachers believe that IWBs can be used to facilitate learning and instruction under the following conditions, 1) collaboration with colleagues, 2) training about effective instructional strategies using IWB, and 3) more frequent teacher use of IWBs to improve IWB competency.
The number of children receiving treatment with anticoagulants for thromboembolic complications has risen over the last decade(1). Children's physiologic response to anticoagulants is inherently different to that of adults (2-6). The complexity of anticoagulation management in the acute setting has led to the development of dedicated Anticoagulation Services within many major paediatric centres (7-13).This article is protected by copyright. All rights reserved.
Prior research has identified deficiencies in the standard process of providing instructions for care at discharge from the emergency department (ED). Patients typically receive a brief verbal instruction, along with preformatted written discharge documents. Studies have found that understanding and retention of such information by families are very poor, leading to nonadherence in follow-up care, unnecessary return visit to the ED, and poor health outcomes. The combination of systems factors (information content, delivery methods, and timing) and patient factors (health literacy, language proficiency, and cultural factors) contributes to the challenge of providing successful discharge communication. Internet and mobile devices provide a novel opportunity to better engage families in this process.Mobile health can address both system- and patient-level challenges. By incorporating images, animation, and full Web-based video content, more comprehensible content that is better suited for patients with lower health literacy and today's visual learners can be created. Information can also be delivered both synchronously and asynchronously, enabling the health care providers to deliver health education to the patients electronically to their home, where health care occurs. Furthermore, the providers can track information access by patients, customize content to the individual patients, and reach other caregivers who may not be present during the ED visit. Further research is needed to develop the systems and best practices for incorporating mobile health in the ED setting.
Introduction:
Management of oral anticoagulant therapy (OAT) in children is complex and frequent testing of the International Normalised Ratio (INR) is a significant burden. This study evaluates the impact of a home INR self-testing (home ST) program on the quality of life (QoL) of children and their families. The aim of the study was to determine if participation in a home ST program improves QoL for children requiring long-term OAT and their families.
Materials and methods:
Children aged eight to 18 years requiring long-term OAT and parents of children participated. Quantitative methods comprised three validated QoL questionnaires; the anticoagulation specific PAC QL©, the PedsQL™ and the PedsQL FIM™. Questionnaires were completed before commencing home ST and 6-12 months later. Qualitative methods consisted of open-ended questions which participants answered when completing the questionnaires for the second time. Results of INRs tested at home were collected.
Results:
Fifty-five parents and 35 children participated. The percentage of time the children's INRs were in their target therapeutic range was 71.3. Parents reported statistically significant improvements in QoL for themselves (mean increase 6.9), their family (mean increase 8.6) and their child (mean increase 11.1) following the commencement of home ST (difference p≤0.003 on all questionnaires). The children did not report a statically significant improvement in QoL.
Conclusion:
Parents reported significant improvement for their child's QoL, their QoL and the families' function following commencement of home ST. Children did not report a significant improvement in their QoL, but clearly identified satisfaction with home ST.
Neonates and children are receiving anticoagulation therapy much more frequently now than at any time in the past. There are a multitude of factors which contribute to this trend and they are well described elsewhere. The majority of recent reviews of anticoagulation therapy in children have focussed, not inappropriately, on the specific anticoagulant agents used, and our lack of knowledge about their basic pharmacokinetics, pharmacodynamics, and impact on commonly used monitoring tests. This review will address some of the difficulties of anticoagulation in children from the other perspective, considering specific patient populations such as neonates and adolescents, and also specific clinical situations which increase the complexity of anticoagulation such as in children with cancer, or children who need invasive procedures. There remains just as much research required into how best to manage these populations and circumstances as is required to understand the basic mechanisms of anticoagulant interactions with paediatric plasma.
Measurement of quality of life (QOL) has been accepted as an important outcome measure in therapeutic clinical trials. Long-term antithrombotic therapy is hypothesized to induce treatment dissatisfaction and influence QOL. Health-related quality of life (HRQOL) can be measured by an inventory developed specific to the patient condition. Pediatric QOL inventory for children on long-term antithrombotic therapy should assess constructs salient for this population. Creation of an HRQOL measurement inventory requires rigor and methodological adherence. Identification and evaluation of QOL constructs is critical to improve care and is accepted as the "gold standard" measurement for patient-centered outcomes in clinical research. The use of a valid and reliable HRQOL inventory specific for the antithrombotic therapy is required for upcoming clinical trials as it will provide a method to measure change in HRQOL specific to the antithrombotic agent. In this way, it will be possible to provide the child/family with information to make safe and effective therapeutic choices, define future antithrombotic therapy research strategies, and inform decision makers to change policies to improve health care.
This study tested the efficacy of a multimedia interactive DVD as an education tool for patients with end-stage renal disease in terms of enhancing patient knowledge and decision-making skills and decreasing uncertainty.
End-stage renal case numbers in Taiwan are growing by approximately 6000 new patients per year. Helping patients choose an optimal treatment method to maximise quality of life is an important healthcare issue for this patient population.
This study adopted a quasi-experimental design and focused on subjects being treated at one medical centre in southern Taiwan. The study divided subjects into experimental and control groups.
The experimental group received three multimedia interactive DVD nursing-guided interventions. The control group received only normal hospital health education. The study gathered data using several scales addressing knowledge, uncertainty perception and decision regret. Scales were implemented immediately before and after the multimedia interactive DVD nursing guidance intervention and at four and eight weeks postintervention. This study used an independent t-test, chi-square test and repeated measures analysis of variance.
This study found significant improvements in the experimental group in terms of knowledge, pre-dialysis uncertainty and decision regret. Experimental group subjects scored particularly less in terms of decision regret than those in the control group.
This study demonstrated the efficacy of the developed multimedia interactive DVD in significantly improving end-stage renal patient knowledge and reducing patient uncertainties and postdecision regret. Study findings can be used as a reference guide for clinical nursing education efforts in hospital and other healthcare settings.
This article concerning the pharmacokinetics and pharmacodynamics of vitamin K antagonists (VKAs) is part of the American College of Chest Physicians Evidence-Based Clinical Practice Guidelines (8th Edition). It describes the antithrombotic effect of the VKAs, the monitoring of anticoagulation intensity, and the clinical applications of VKA therapy and provides specific management recommendations. Grade 1 recommendations are strong and indicate that the benefits do or do not outweigh the risks, burdens, and costs. Grade 2 recommendations suggest that the individual patient's values may lead to different choices. (For a full understanding of the grading, see the "Grades of Recommendation" chapter by Guyatt et al, CHEST 2008; 133:123S-131S.) Among the key recommendations in this article are the following: for dosing of VKAs, we recommend the initiation of oral anticoagulation therapy, with doses between 5 mg and 10 mg for the first 1 or 2 days for most individuals, with subsequent dosing based on the international normalized ratio (INR) response (Grade 1B); we suggest against pharmacogenetic-based dosing until randomized data indicate that it is beneficial (Grade 2C); and in elderly and other patient subgroups who are debilitated or malnourished, we recommend a starting dose of < or = 5 mg (Grade 1C). The article also includes several specific recommendations for the management of patients with nontherapeutic INRs, with INRs above the therapeutic range, and with bleeding whether the INR is therapeutic or elevated. For the use of vitamin K to reverse a mildly elevated INR, we recommend oral rather than subcutaneous administration (Grade 1A). For patients with life-threatening bleeding or intracranial hemorrhage, we recommend the use of prothrombin complex concentrates or recombinant factor VIIa to immediately reverse the INR (Grade 1C). For most patients who have a lupus inhibitor, we recommend a therapeutic target INR of 2.5 (range, 2.0 to 3.0) [Grade 1A]. We recommend that physicians who manage oral anticoagulation therapy do so in a systematic and coordinated fashion, incorporating patient education, systematic INR testing, tracking, follow-up, and good patient communication of results and dose adjustments [Grade 1B]. In patients who are suitably selected and trained, patient self-testing or patient self-management of dosing are effective alternative treatment models that result in improved quality of anticoagulation management, with greater time in the therapeutic range and fewer adverse events. Patient self-monitoring or self-management, however, is a choice made by patients and physicians that depends on many factors. We suggest that such therapeutic management be implemented where suitable (Grade 2B).
The complexities of managing oral anticoagulation therapy in children have been well described and various management strategies have been designed to optimise clinical outcomes within this challenging population. To date, outcome measurements used within paediatric studies investigating oral anticoagulant management have focused upon achieving therapeutic range and examining the incidence of medication-related adverse events. Whilst the reporting of such data is a priority, the relatively small number of children participating in clinical studies of oral anticoagulant management and the difficulties associated with conducting multi-centre interventional trials in such populations limit the ability of researchers to measure the significance of interventions made. This review examines current methods of reporting outcomes for paediatric oral anticoagulation management and identifies how the inclusion of quality of life as an outcome measure may strengthen the methodology of research aimed at measuring the impact of management interventions within the field of paediatric oral anticoagulant therapy.
Increasing numbers of children require warfarin thromboprophylaxis. Home INR testing by the patient (PST) has revolutionized warfarin management. However, the family/patient must contact the health team for guidance for warfarin dosing. Patient self management(PSM) prepares a patient performing PST to take an active role in warfarin dosing. Adult studies demonstrate that PSM is safe and effective with improved adherence and treatment satisfaction quality of life (QOL).
To estimate the safety and efficacy in children performing PSM or PST, to evaluate warfarin dose decision making in PSM, and warfarin related QOL.
Warfarinized children performing PST for >3m were randomized to PST or PSM. The PSM group underwent warfarin management education and assumed independent warfarin management. INRs were collected for a year prior to and for 1 year of study to determine TTR and warfarin decision making. QOL was assessed through inventory completion and interviews.
28 children were randomized and followed for 12 months. TTR was (83.9% pre/ post), and 77.7% pre to 83.0% post for PST and PSM (p=0.312). Appropriate warfarin decision making was 90% with no major bleeding episodes and no thromboembolic events. PSM was preferred by families. Conclusions: PSM for children may be a safe and effective management strategy for warfarinized children. Clinical studies with larger sample size are required.
Long term anticoagulation (LTA) is hypothesized to induce treatment dissatisfaction influence quality of life (QOL). QOL is measured by a tool developed specific to the patient condition. Pediatric QOL inventory for children on LTA should assess constructs salient for this population. Identification and evaluation of QOL constructs, critical to improve care, and is accepted as the "gold-standard" measurement for patient-centered outcomes in clinical research.
To develop and preliminarily validate a pediatric QOL inventory for children/families receiving LTA. Secondary objective was to determine how anticoagulation disrupts children's life.
Stage 1: Item/theme generation through focus groups and existing inventories, Stage 2: Item reduction, inventory generation and content validity. Stage 3: Inventory refinement, implementation and reliability testing. Responses were evaluated for variability, internal consistency, and scale structure. Item reduction was based on response rate, item variability, and clinical utility.
Two inventories, KIDCLOT-PAC-Child -Tween QL and KIDCLOT-PAC Parent-proxy-QL were developed. Content and face validity was assessed by experts, parents, and patients. Internal consistency determined by Cronbach's alpha was good for parent-proxy(0.82) and child(0.89). Pearson correlation was acceptable with >0.5 for test-retest reliability (parent inventory).
KIDCLOT-PAC-QL is the first preliminarily validated inventory to assess QOL in anticoagulated children. The inventory identifies barriers in care and areas for improvement in order to modify care to provide the "best" management (improved QOL associated with safety and efficacy) for children requiring LTA.
Advances in medical and surgical therapy in children have resulted in increased survival in children with primary illnesses. However, thrombosis is a serious complication of this success and results in mortality and morbidity. Prevention or treatment of thrombosis using warfarin is challenging in children due to its narrow therapeutic index and the unique differences in children, including variable nutritional intake and the occurrence of common concomitant viral or bacterial illnesses which alter warfarin metabolism. The variable response to warfarin in children necessitates frequent International Normalized Ratio (INR) monitoring. Education may improve time in therapeutic range (TTR) a measure of warfarin effect, and a surrogate for patient adherence, safety and efficacy.
The Pediatric Anticoagulation program (Stollery Children's Hospital) developed a novel child-focused educational program KIDCLOT-POC about warfarin therapy and POC-INR meter use. A total of twenty eight children, and their caregivers, participated in KIDCLOT-POC. Questionnaire score comparisons and practical demonstrations assessed the learners' theoretical and practical knowledge of warfarin management.
In caregivers, the median pre, post and knowledge retention questionnaire scores were 50 (IQR 27), 93 (IQR 6) (p<0.0001) and 96 (IQR 6) (p<0.0001), respectively. In the 18 children who were >or=6 years of age, post and knowledge retention questionnaire scores were 90 (IQR 16) and 92 (IQR 23) (p=0.44), respectively. The TTR for all children was 81.7% (SD 13.1).
Implementation of KIDCLOT-POC program appears to promote high knowledge development and retention in children and caregivers and high TTR with no adverse events.
To evaluate the effect of cartoon illustrations on patient comprehension of and compliance with ED release instructions.
A prospective, randomized, controlled study of consecutive patients who presented to the ED of a community teaching hospital with lacerations necessitating wound repair during a three-month study period. At ED release, the patients were randomly assigned to receive wound care instructions with or without cartoon illustrations. Three days later, the patients were followed up by telephone. A blinded investigator asked a series of questions designed to test the patient's recall of, understanding of, and compliance with wound care instructions.
A total of 234 patients were successfully contacted by telephone; 105 (45%) had been given ED release instructions with cartoons, 129 (55%), without cartoons. There was no significant difference in age, gender, level of education, or satisfaction with the ED visit between the two groups. The patients given cartoon instructions were more likely to have read the instructions (98% vs 79%, p < 0.001), were more likely to answer all wound care questions correctly (46% vs 6%, p < 0.001), and were more compliant with daily wound care (77% vs 54%, p < 0.01). Subset analysis of those patients who had less than a high school education (n = 57) demonstrated even larger differences between the two treatment groups in terms of comprehension of and compliance with ED release instructions.
Cartoon illustrations are an effective strategy for conveying information and may improve patient compliance with ED release instructions.
Functional health literacy is associated with illness-related knowledge, understanding, and treatment perceptions for several chronic illnesses. This study examined health literacy in relation to knowledge and understanding of HIV/AIDS.
Persons living with HIV/AIDS recruited from AIDS service organizations and HIV clinics completed the Test of Functional Health Literacy for Adults (TOFHLA) reading comprehension scale and measures of health status, knowledge and understanding of health status, perceptions of primary care givers, and perceptions of anti-HIV treatments.
Eighteen percent of the sample scored below the cutoff for marginal functional health literacy on the TOFHLA. Controlling for years of education, persons of lower health literacy were significantly less likely to have an undetectable HIV viral load, somewhat less likely to know their CD4 cell count and viral load, and lower health-literacy persons who knew their CD4 count and viral load were less likely to understand their meaning. Lower health literacy was also related to misperceptions that anti-HIV treatments reduce risks for sexually transmitting HIV and beliefs that anti-HIV treatments can relax safer-sex practices.
Poor health literacy creates barriers to fully understanding one's health, illness, and treatments. Misperceptions of treatment in the case of HIV infection creates danger for potentially transmitting treatment-resistant strains of HIV. These results have implications for patient education and treatment programming for people who have poor health-literacy skills and are living with HIV/AIDS.
Many older adults in Medicare managed care programs have low health literacy, and this may affect use of preventive services.
To determine whether older adults with inadequate health literacy were less likely to report receiving influenza and pneumococcal vaccinations, mammograms, and Papanicolaou smears than individuals with adequate health literacy after adjusting for other covariates.
Cross-sectional survey; home interviews with community dwelling enrollees.
Medicare managed care enrollees 65 to 79 years old in four US cities (n = 2722).
Short Test of Functional Health Literacy in Adults and self-reported preventive service use.
In bivariate analyses, self-reported lack of preventive services was higher among individuals with inadequate health literacy than those with adequate health literacy: never had an influenza vaccination: 29% versus 19% (P = 0.000); never had a pneumococcal vaccination: 65% versus 54% (P = 0.000); no mammogram in the last 2 years: 24% versus 17% (P = 0.017); never had a Papanicolaou smear: 10% versus 5% (P = 0.002). After adjusting for demographics, years of school completed, income, number of physician visits, and health status, people with inadequate health literacy were more likely to report they had never received the influenza (OR, 1.4; 95% CI, 1.1-1.9) or pneumococcal vaccination (OR, 1.3; 95% CI, 1.1-1.7), and women were less likely to have received a mammogram (OR, 1.5; 95% CI, 1.0-2.2) or Papanicolaou smear (OR, 1.7; 95% CI, 1.0-3.1).
Among Medicare managed care enrollees, inadequate health literacy is independently associated with lower use of preventive health services.
The aim of anticoagulation treatment is to reach an optimal international normalised ratio (INR) level in which the risk of thrombosis as well as bleeding is minimal. Recently developed methods that allow self-managed control of anticoagulation make more frequent testing possible and may thus represent a better alternative than conventional control.
In this meta-analysis, randomized, controlled trials comparing self-management with conventional control with regard to time in therapeutic range and number of bleedings and thromboses were investigated. Eight clinical trials fulfilled the criteria for inclusion, representing about 870 patient-years and 1300 patients.
The difference in time in therapeutic range was on average 10% in favour of self-management. The rate of major and fatal bleedings was 3.5% per patient-years with conventional control, 2.4% per patient-years with self-management. The rate of thrombosis was 3.9% per patient-years with conventional control as against 2.7% with self-management. OddsratioMH for major clinical events was 0.62 (95% CI 0.429, 0.895); p < 0.01.
This meta-analysis shows that self-managed control of anticoagulation improves safety and efficacy and is probably a better alternative than conventional control for selected groups of patients.
To examine the impact of low health literacy on medical care use and costs.
The study sample consisted of 3260 noninstitutionalized elderly persons enrolling in a Medicare managed care plan in 1997 in Cleveland, Ohio; Houston, Texas; South Florida; and Tampa, Florida. Health literacy--the degree to which individuals have the capacity to obtain, process, and understand basic health information and services needed to make appropriate health decisions--was measured using the Short Test of Functional Health Literacy in Adults. We used a 2-part regression model to examine the association between health literacy and medical costs, adjusting for age, sex, race/ethnicity, education, income, alcohol and tobacco consumption, and comorbid conditions. Results are presented as mean differences (with 95% confidence intervals [CI]) between the inadequate and adequate groups and, separately, the marginal and adequate groups.
When compared to those with adequate health literacy, emergency room costs were significantly higher (62 to 1551; 95% CI: -3267; P = 0.08) and inpatient (89 to 596; 95% CI: -2630; P = 0.57).
Persons with inadequate health literacy incur higher medical costs and use an inefficient mix of services.
People often miss taking prescribed medication, because of forgetfulness, changing medication schedules or busy lifestyles. It is estimated that between 40% and 60% of people do not take medication as prescribed, which can lead to worse health outcomes. Packaging of medications with reminder systems for the day and/or time of the week is an attempt to help people take long-term medications. We assessed eight studies involving 1,137 participants who were taking self-administered medications for at least one month. The studies involved different types of packaging, and different medications for a variety of health problems. We found that reminder packaging increased the proportion of people taking their medications when measured by pill count; however, this effect was not large. We found insufficient information to say whether reminder packaging had an effect on improving health outcomes. Reminder packing for certain individuals may represent a simple method for improving the taking of medications; further research is needed to improve the design and targeting of these devices.
Near-patient testing has made self-monitoring of anticoagulation with warfarin feasible, and several trials have suggested that such monitoring might be equal to or better than standard monitoring. We did a systematic review and meta-analysis of all randomised controlled trials that assessed the effects of self-monitoring or self-management (self-testing and self-dosage) of anticoagulation compared with standard monitoring.
We searched the Cochrane Register of Controlled Trials, MEDLINE, EMBASE to April 2005, and contacted manufacturers and authors of relevant studies. Outcomes analysed were: major haemorrhage, thromboembolic events, death, tests in range, minor haemorrhage, frequency of testing, and feasibility of self-monitoring.
We identified 14 randomised trials of self-monitoring: pooled estimates showed significant reductions in thromboembolic events (odds ratio 0.45, 95% CI 0.30-0.68), all-cause mortality (0.61, 0.38-0.98), and major haemorrhage (0.65, 0.42-0.99). Trials of combined self-monitoring and self-adjusted therapy showed significant reductions in thromboembolic events (0.27, 0.12-0.59) and death (0.37, 0.16-0.85), but not major haemorrhage (0.93, 0.42-2.05). No difference was noted in minor haemorrhage. 11 trials reported improvements in the mean proportion of international normalisation ratios in range.
Self-management improves the quality of oral anticoagulation. Patients capable of self-monitoring and self-adjusting therapy have fewer thromboembolic events and lower mortality than those who self-monitor alone. However, self-monitoring is not feasible for all patients, and requires identification and education of suitable candidates.
Interventions for restoring patency of central venous catheter lumens
- Bauman
Communicating breast cancer screening with young women: an experimental test of didactic and narrative messages using video and infographics
- Arcia