Abstract P199: Randomized Comparison of the DAWN AC Computer Program and a Simple Manual Nomogram for Quality of Warfarin Dosing

Author(s):  
Robby Nieuwlaat ◽  
Lowiek Hubers ◽  
Alex C Spyropoulos ◽  
Alexander Stehouwer ◽  
Harriette G Van Spall ◽  
...  

Background In patients receiving warfarin, the quality of anticoagulant control as measured by the time-in-therapeutic range (TTR) for the International Normalized Ratio (INR) is a key determinant of risk for thromboembolic and bleeding events. Computer programs can assist physicians in optimizing TTR, but are expensive. The purpose of this study was to determine whether a computer system (DAWN AC) was non-inferior to a two-step manual nomogram used in a hospital anticoagulation clinic. Methods Stable anticoagulated patients receiving warfarin with target INR range 2-3 in the anticoagulation clinic were randomized to management with the newly acquired DAWN AC computer system or the clinic's standard of care, a simple manual dosing nomogram. After an initial run-in phase, study data collection started on February 1 st 2010 and was completed on August 8 th 2010. Primary outcome was the mean TTR calculated by the Rosendaal linear interpolation method. The non-inferiority margin was set at 4.5% lower TTR for DAWN AC compared with the nomogram. Results Of the 1,298 patients initially randomized, 1,127 were still managed by the clinic after the run-in phase and entered the study on February 1 st ; 564 were managed with DAWN AC, and 563 with the manual nomogram. The mean age of study patients was 69 ± 14 years and 62% were male. Main indications for anticoagulation were atrial fibrillation (48%) and prosthetic heart valves (25%). Mean follow-up was 172 days, encompassing 8,344 INR values and 155,041 patient days. Adherence to recommended warfarin doses was higher in the DAWN AC than in the nomogram group (99 vs. 90%; p<0.0001), the average interval between INR measurements was similar in the two groups (21 ± 12 vs. 21 ± 13 days; p=0.1987). In the primary analysis, mean TTR in the DAWN AC group was non-inferior to mean TTR in the nomogram group (71.0% ± 23.3 vs. 71.9% ± 22.9; non-inferiority p=0.0052). Conclusion Among stable patients receiving warfarin with a target INR of 2-3 in an anticoagulation clinic, quality of anticoagulant control with the DAWN AC computer program was non-inferior to a simple two-step manual dosing nomogram. The nomogram could be a useful dosing tool for physicians without access to a computerized warfarin dosing system.

2018 ◽  
Vol 36 (6) ◽  
pp. 349-357 ◽  
Author(s):  
Simen Svenkerud ◽  
Hugh MacPherson

Background Clear and unambiguous reporting is essential for researchers and clinicians to be able to assess the quality of research. To enhance the quality of reporting, consensus-based reporting guidelines are commonly used. Objectives To update and extend previous research by evaluating the more recent impact of STRICTA (STandards for Reporting Interventions in Controlled Trials of Acupuncture) and CONSORT (CONsolidated Standards Of Reporting Trials) guidelines on the quality of reporting of acupuncture trials. Methods By random sampling, approximately 45 trials from each of five 2-year time periods between 1994 and 2015 were included in the study. Using scoring sheets based on the STRICTA and CONSORT checklist items (range 0 to 7 and 0 to 5, respectively), the distribution of items reported over time was investigated, with changes shown using scatterplots. The primary analysis used a before-and-after t-test to compare time periods. A meta-analysis investigated whether or not trials published in journals that endorsed STRICTA were associated with better reporting. Results The study included 207 trials. Improved reporting of items over time was observed, as represented by changes in the scatterplot slope and intercept. The mean STRICTA score increased from 4.27 in the 1994–1995 period to 5.53 in 2014–2015, an 18% improvement. The mean CONSORT score rose from 1.01 in the 1994–1995 period to 3.32 in 2014–2015, an increment of 46%. There was proportionately lower reporting for items related to practitioner background (STRICTA) and for randomisation implementation and allocation concealment (CONSORT). Trials published in journals that endorsed STRICTA had statistically significantly superior reporting of both STRICTA and CONSORT items overall. Conclusion This study has provided evidence of an improvement in reporting of STRICTA and CONSORT items over the time period from 1994 to 2015. Journals that endorse STRICTA have a better record in terms of reporting quality. Some evidence suggests that the publication of STRICTA has had a positive impact on reporting quality.


Blood ◽  
2004 ◽  
Vol 104 (11) ◽  
pp. 2202-2202
Author(s):  
Ole Hauch ◽  
Michael F. Bullano ◽  
Chaitanya Sarawate ◽  
Thomas Iarocci ◽  
Vince J. Willey ◽  
...  

Abstract In the prophylactic anticoagulation of patients with venous thromboembolism (VTE), effective prophylaxis and risk of major bleeding event are two key concerns. In a recent study (Willey et al, Clin Ther2004: 26(7);1149–59), we demonstrated that VTE treatment in routine care in the managed care setting seems to be less effective from the outcomes perspective than what has been reported in clinical trials. It has been clearly demonstrated in chronic non valvular atrial fibrillation that there is an association between INR values and thromboembolic events and major bleeding events (Hylek et al, Ann Intern Med1994: 120;897–902 and Hylek et al, N Engl J Med1996: 335;540–46). In the actual practice setting, we examined the quality of INR control and the relationship between INR and recurrent VTE and bleeding event as well as the prognostic utility of INR monitoring for anticipating bleeding event and VTE recurrence. We conducted a retrospective, case-control analysis using medical and pharmacy claims spanning 4.5 years (10/1998–2003). A cohort of patients with incident VTE followed by anticoagulation prophylaxis was identified using pharmacy and medical claims (ICD-9 codes 451.1x, 451.8x, 415.1x). All subsequent hospitalizations were identified using the medical claims, and diagnoses for bleeding event and VTE were validated during medical record abstraction. INR values from both outpatient and inpatient settings were used to yield a continuous history of coagulation status. The resulting population (mean age 67 ±14; 38% male) had VTE, had begun anticoagulation, and was subsequently hospitalized. Within this population, groups were hospitalized for VTE (n=141), bleeding event (n=48), or for reasons other than VTE or bleeding event (control, n=275). The average time in therapeutic INR range (2.0 – 3.0) was 34% with 48% below and 18% above (Rosendaal’s linear interpolation method). Odds ratios relating bleeding event or VTE to INR values outside therapeutic INR range were calculated using univariate logistic regression analysis. First inpatient INR upon admission was predictive for the VTE or bleeding event (see figure). However, the outpatient INR values in closest time proximity prior to the VTE or bleeding appeared only to predict bleeding event and not VTE. Bleeding event was predicted by last outpatient INR > 3.0; bleeding likelihood was increased by a factor of approximately 2 to 3 for analyses using mean and lowest of last 3 INR values, respectively. Most recent INR value(s) prior to event did not predict VTE regardless of whether lowest, highest, or mean of last 3 values was used. Last outpatient INR value preceded the event by a median of 18, 26, and 21 days (VTE, bleeding event, and control, respectively). There is a clear relationship between INR at time of event and adverse outcome. However, for outpatient INR, low percent time in range and an apparent lack of predictive value for recurrent VTE signal there may be opportunity for quality improvement in management of anticoagulation for recurrent VTE. Figure Figure


2019 ◽  
Vol 119 (04) ◽  
pp. 675-684 ◽  
Author(s):  
Stefano Barco ◽  
Serena Granziera ◽  
Michiel Coppens ◽  
Jonathan Douxfils ◽  
Mathilde Nijkeuter ◽  
...  

Background Time in therapeutic range (TTR) measures the quality of vitamin K antagonist (VKA) anticoagulation. In patients with atrial fibrillation, the dichotomized SAMe-TT2-R2 score (≥2 vs. < 2 points) can predict if adequate TTR is unlikely to be achieved. Aims We validated the SAMe-TT2-R2 score in patients with venous thromboembolism (VTE) randomized to the warfarin arm of the Hokusai-VTE trial. Patients and Methods A total of 3,874 patients were included in the primary analysis (day 31–180 from randomization). The efficacy and safety outcomes were symptomatic recurrent VTE and major or clinically relevant non-major bleeding. Results The rates of recurrent VTE and bleeding events were higher in patients with a TTR below the median (< 66% vs. ≥66%) resulting in an absolute risk difference (ARD) of +0.5% (95% confidence interval: 0%, +1.1%) and +2.2% (0.9%, +3.5%), respectively. Patients with high SAMe-TT2-R2 score were 76% of total and had lower median TTR (64.7% vs. 70.7%). The SAMe-TT2-R2 score exhibited low negative (0.59) and positive (0.52) predictive value (TTR threshold 66%), and poor discrimination (c-statistic, 0.58). ARD between patients with high and low score was 0% (–0.6%, +0.7%) for recurrence and +1.3% (–0.1%, +2.7%) for bleeding. Results were confirmed in sensitivity analyses focusing on the whole study period (day 1–365). Conclusion In VTE patients, the SAMe-TT2-R2 score showed unsatisfactory discrimination and predictive value for individual TTR and did not correlate well with clinical outcomes. The choice of starting a patient on VKA cannot be based on this parameter and its routine use after VTE may not translate into clinical usefulness.


2016 ◽  
Vol 116 (08) ◽  
pp. 241-250 ◽  
Author(s):  
Richard P. Whitlock ◽  
Christopher B. Fordyce ◽  
Mark G. Midei ◽  
Dave Ellis ◽  
David Garcia ◽  
...  

SummaryTecarfarin is a novel vitamin K antagonist that is metabolised by carboxyl estererase, thereby eliminating the variability associated with cytochrome-mediated metabolism. EmbraceAC was designed to compare the quality of anticoagulation with tecarfarin and warfarin as determined by time in therapeutic range (TTR). In this phase 2/3 randomised and blinded trial, 607 patients with indications for chronic anticoagulation were assigned to warfarin (n=304) or tecarfarin (n=303). Dosing of study drugs was managed by a centralised dose control centre, which had access to genotyping. The primary analysis tested superiority of tecarfarin over warfarin for TTR. Patients were recruited between May 12, 2008 and May 12, 2009. TTR with tecarfarin and warfarin were similar (72.3% and 71.5%, respectively; p=0.51). In those taking CYP2C9 interacting drugs, the TTR on tecarfarin (n=92) was similar to that on warfarin (n=87, 72.2% and 69.9%, respectively; p=0.15). In patients with mechanical heart valves, the TTR of tecarfarin (n=42) was similar to that of warfarin (n=42, 68.4% and 66.3%, respectively; p=0.51). The same was true for the TTR in patients with any CYP2C9 variant allele and on CYP2C9-interacting drugs (tecarfarin, n=24, 76.5% vs warfarin, n=31, 69.5%; p=0.09). There was no difference in thromboembolic or bleeding events. In conclusion, superiority of tecarfarin over warfarin for TTR was not demonstrated. The TTR with tecarfarin was similar to that with well-controlled warfarin and tecarfarin appeared to be safe and well tolerated with few major bleeding and no thrombotic events. Favourable trends in certain subpopulations make tecarfarin a promising oral anticoagulant that deserves further study.Supplementary Material to this article is available online at www.thrombosis-online.com.


1995 ◽  
Vol 74 (02) ◽  
pp. 622-625 ◽  
Author(s):  
H H Brackmann ◽  
R Egbring ◽  
A Ferster ◽  
P Fondu ◽  
J M Girardel ◽  
...  

SummaryThe pharmacokinetics and tolerability of factor XIII (FXIII) from plasma were compared with those of FXIII from placenta in a randomised, double-blind, crossover study involving 13 patients with congenital FXIII deficiency. Both FXIII activity and FXIII antigen were monitored. No difference was seen in the mean half-lives of the two preparations (9.3 days and 9.1 days for plasma and placenta FXIII activity, respectively). Response was similar for both preparations, but was slightly greater for FXIII from plasma.Similar results were found for recovery (65% vs 60%). The area under the data completed by extrapolation was significantly higher for FXIII from plasma. No differences between preparations in terms of efficacy or tolerability were observed. It can be concluded that treatment with FXIII concentrate from plasma is as efficient as with FXIII concentrate from placenta in terms of recovery and half-life. Both preparations were equivalent in terms of safety during the observation period. With the administration of monthly injections of approximately 30 U/kg serious bleeding events were prevented and no other serious adverse events occurred.


2019 ◽  
Vol 11 (1) ◽  
pp. 9-18
Author(s):  
Abdul Wakhid ◽  
Ana Puji Astuti ◽  
Maya Kurnia Dewi

Logoterapi merupakan terapi untuk menemukan makna positif dibalik sebuah kejadian yang tidak diharapkan. Logoterapi dilaksanakan secara individu maupun berkelompok dalam bentuk konseling dan berorientasi pada pencarian makna hidup individu. Tujuan logoterapi meningkatkan makna pengalaman hidup individu yang diarahkan kepada pengambilan keputusan yang bertanggung jawab. Penelitian ini dilakukan dengan menggunakan rancangan pre-experiment dengan metode pre and post test group, artinya pengumpulan data dilakukan terhadap responden untuk membandingkan kualitas hidup sebelum dan sesudah dilakukan intervensi. Teknik pengambilan sampel dilakukan dengan metode total sampling yaitu pengambilan seluruh sampel dengan tetap memperhatikan kriteria yang telah ditetapkan. Jumlah pasien yang menjalani hemodialisis di RSUD Ungaran sebanyak 21 orang dan di RSUD Ambarawa sebanyak 25 pasien. Analisis data dilakukan dengan menggunakan uji t test dependent. Hasil penelitian didapatkan bahwa dari 46 responden didapatkan rata-rata skor kualitas hidup pasien yang mejalani hemodialisis sebesar 60.22 dengan skor terrendah 55 dan skor tertinggi 69. Bahwa dari 46 responden didapatkan rata-rata skor kualitas hidup pasien yang mejalani hemodialisis sebesar 88.72 dengan skor terrendah 79 dan skor tertinggi 103. Hasil uji statistik dengan uji t test dependent diketahui ada pengaruh logoterapi terhadap kemampuan memaknai hidup pada klien yang menjalani hemodialisis di RSUD Kabupaten Semarang (p value: 0,0001). Saran perlunya peningkatan kemampuan perawat dalam memberikan layanan kesehatan termasuk pemberian atau pemanduan penemuan makna hidup bagi pasien hemodialysis, agar selain dengan hemodialysis, ada faktor internal dari pasien yang dapat dijadikan sebagai motivasi untuk sembuh dari penyakit.   Kata Kunci: Logoterapi, kualitas hidup   IMPROVE THE QUALITY OF LIFE OF PATIENTS WITH RENAL FAILURE WHO UNDERWENT HEMODIALYSIS   ABSTRACT Logotherapy is a therapy to discover the positive meaning behind an unexpected event. Logotherapy is carried out individually or in groups in the form of counseling and oriented to the search for the meaning of individual life. This study aims to improve the quality of life of patients with renal failure who underwent hemodialysis. This research was conducted by using pre-experiment with pre-post test study. The sampling technique was done by the convenience sampling. The number of patients undergoing hemodialysis as many as 46 respondents. Data analysis was done by using test t test dependent. The result showed that from 46 respondents got the mean of quality of life of patients who had hemodialysis 60.22 with lowest score 55 and highest score 69. Whereas from 46 respondents got the mean score of life quality of patients who had hemodialysis 88.72 with score the lowest score 79 and the highest score 103. The result of statistical test with t test dependent is known there is influence of logoterapi to the ability of meaningful life on client who undergo hemodialysis at Semarang Regency hospitals (p value: 0.0001). Advice on the need to improve the nurse's ability to provide health services, including the provision or guidance of the discovery of the meaning of life for hemodialysis patients, in addition to hemodialysis, there are internal factors of the patient that can be used as a motivation to recover from illness.   Keywords: Logotherapy, quality of life, kidney failure.  


2018 ◽  
Vol 33 (2) ◽  
pp. 62-70 ◽  
Author(s):  
A Hossain ◽  
MM Islam ◽  
F Naznin ◽  
RN Ferdousi ◽  
FY Bari ◽  
...  

Semen was collected from four rams, using artificial vagina and viability%, motility% and plasma membrane integrity% were measured. Fresh ejaculates (n = 32) were separated by modified swim-up separation using modified human tubal fluid medium. Four fractions of supernatant were collected at 15-minute intervals. The mean volume, mass activity, concentration, motility%, viability%, normal morphology and membrane integrity% (HOST +ve) of fresh semen were 1.0 ± 0.14, 4.1 ± 0.1 × 109 spermatozoa/ml, 85.0 ± 1.3, 89.4 ± 1.0, 85.5 ± 0.7, 84.7 ± 0.5 respectively. There was no significant (P>0.05) difference in fresh semen quality parameters between rams. The motility%, viability% and HOST +ve % of first, second, third and fourth fractions were 53.4 ± 0.5, 68.2 ± 0.3, 74.8 ± 0.3 and 65.5 ± 0.4; 55.5 ± 0.4, 66.2 ± 0.4, 74.5 ± 0.3 and 73.6 ± 0.3 and 66.7 ± 0.5, 66.8 ± 0.5, 65.2 ± 0.4 and 74.7 ± 0.5 respectively. The motility%, viability% and membrane integrity% of separated semen samples differed significantly (P<0.05) between four fractions. The mean motility% and viability% were significantly higher (P<0.05) in third fraction (74.8 ± 0.3%), whereas the mean HOST +ve% was significantly higher (P<0.05) in fourth fraction (74.7 ± 0.5). All quality parameters of separated spermatozoa were significantly (P<0.05) lower than that of fresh semen. The pregnancy rates were higher with fresh semen (71%) in comparison to that of separated sample (57%).Bangl. vet. 2016. Vol. 33, No. 2, 62-70


2019 ◽  
pp. 195-207

Background: Autism spectrum disorder is characterized in part by atypical behavior in the communication, social, and visual domains. Success in vision therapy is judged not only by changes in optometric findings, but through improvement in quality of life involving communication, social behavior and visual behavior. It would therefore be beneficial to have a validated questionnaire to assess parent reported quality of life pre and post vision therapy specific to patients with autism spectrum disorder. To our knowledge, a questionnaire of this nature has not been previously published in the literature. Methods: Questionnaire items were generated through surveying medical literature based on symptoms in three different categories: visual behavior, social behavior and communication. A pool of 34 questions was developed initially and then with thorough discussion with other experts, a 20-point questionnaire was developed with each item reflected in the construct concept. A draft of 20 questions was then sent to 10 subject experts with clinical experience in the field for more than 20 years, to review the pooled items. Validity and reliability was established prior to assessing the psychometric properties of the ASD/QOL-VT. Prospective observational study was conducted for a duration of 18 months. The study included individuals undergoing vision therapy in the age range of 3 to 15 years who had been diagnosed with ASD. The questionnaire was administered to parents of these children prior to the start of vision therapy. All subjects completed a minimum of 60 vision therapy sessions. The questionnaire was readministered after completing 60 sessions of vision therapy. Results: Cronbach’s alpha value for this questionnaire was 0.93, which reflected very good internal consistency. Factorial analysis yielded four factors with an Eigen value exceeding 1.0 which accounted for 68% variation in the model. The Cronbach alpha value for subscales identified by factorial analysis is 0.97 indicating excellent internal reliability. The mean pre vision therapy social behavior, communication and visual behavior score was 12.0±3.21, 17.07±4.57 and 26.97±6.41 respectively. The mean post vision therapy scores for social behavior, communication and visual behavior was 8.27±4.16, 11.33±5.27 and 17.93±6.52 respectively. On paired t test, the mean difference in score was statistically significant with P<0.001 in all three subcategories. Conclusions: Our study presents the development of a valid and reliable parent questionnaire, the ASD/QOL-VT, that judges communication, social behavior, and visual behavior in autism. Results of the study conducted indicate that vision therapy can result in significant improvements in the quality of life of patients with ASD as judged by their parents. This is evidenced by statistically significant changes in psychometric properties of the ASD/QOL-VT in social behavior, communication and visual behavior.


2020 ◽  
Vol 26 (4) ◽  
pp. 353-363 ◽  
Author(s):  
Kathrin Zimmerman ◽  
Bobby May ◽  
Katherine Barnes ◽  
Anastasia Arynchyna ◽  
Elizabeth N. Alford ◽  
...  

OBJECTIVEHydrocephalus is a chronic medical condition that has a significant impact on children and their caregivers. The objective of this study was to measure the quality of life (QOL) of children with hydrocephalus, as assessed by both caregivers and patients.METHODSPediatric patients with hydrocephalus and their caregivers were enrolled during routine neurosurgery clinic visits. The Hydrocephalus Outcomes Questionnaire (HOQ), a report of hydrocephalus-related QOL, was administered to both children with hydrocephalus (self-report) and their caregivers (proxy report about the child). Patients with hydrocephalus also completed measures of anxiety, depression, fatigue, traumatic stress, and headache. Caregivers completed a proxy report of child traumatic stress and a measure of caregiver burden. Demographic information was collected from administration of the Psychosocial Assessment Tool (version 2.0) and from the medical record. Child and caregiver HOQ scores were analyzed and correlated with clinical, demographic, and psychological variables.RESULTSThe mean overall HOQ score (parent assessment of child QOL) was 0.68. HOQ Physical Health, Social-Emotional Health, and Cognitive Health subscore averages were 0.69, 0.73, and 0.54, respectively. The mean overall child self-assessment (cHOQ) score was 0.77, with cHOQ Physical Health, Social-Emotional Health, and Cognitive Health subscore means of 0.84, 0.79, and 0.66, respectively. Thirty-nine dyads were analyzed, in which both a child with hydrocephalus and his or her caregiver completed the cHOQ and HOQ. There was a positive correlation between parent and child scores (p < 0.004 for all subscores). Child scores were consistently higher than parent scores. Variables that showed association with caregiver-assessed QOL in at least one domain included child age, etiology of hydrocephalus, and history of endoscopic third ventriculostomy. There was a significant negative relationship (rho −0.48 to −0.60) between child-reported cHOQ score and child-reported measures of posttraumatic stress, anxiety, depression, and fatigue. There was a similar significant relationship between caregiver report of child’s QOL (HOQ) and caregiver assessment of the child’s posttraumatic stress symptoms as well as their assessment of burden of care (rho = −0.59 and rho = −0.51, respectively). No relationship between parent-reported HOQ and child-reported psychosocial factors was significant. No clinical or demographic variables were associated with child self-assessed cHOQ.CONCLUSIONSPediatric patients with hydrocephalus consistently rate their own QOL higher than their caregivers do. Psychological factors such as anxiety and posttraumatic stress may be associated with lower QOL. These findings warrant further exploration.


2019 ◽  
Author(s):  
Yaobin Yin ◽  
Jianguang Ji ◽  
Peng Lu ◽  
Wenyao Zhong ◽  
Liying Sun ◽  
...  

BACKGROUND With online health information becoming increasingly popular among patients and their family members, concerns have been raised about the accuracy from the websites. OBJECTIVE We aimed to evaluate the overall quality of the online information about scaphoid fracture obtained from Chinese websites using the local search engines. METHODS We conducted an online search using the keyword “scaphoid fracture” from the top 5 search engines in China, i.e. Baidu, Shenma, Haosou, Sougou and Bing, and gathered the top ranked websites, which included a total of 120 websites. Among them, 81 websites were kept for further analyses by removing duplicated and unrelated one as well as websites requiring payment. These websites were classified into four categories, including forum/social networks, commercials, academics and physician’s personals. Health information evaluation tool DISCERN and Scaphoid Fracture Specific Content Score (SFSCS) were used to assess the quality of the websites. RESULTS Among the 81 Chinese websites that we studied, commercial websites were the most common one accounting more than half of all websites. The mean DISCERN score of the 81 websites was 25.56 and no website had a score A (ranging from 64 to 80).The mean SFSCS score was 10.04 and no website had a score A (range between 24 and 30). In addition, DISCERN and SFSCS scores from academic and physician’s websites were significantly higher than those from the forum/social networks and commercials. CONCLUSIONS The overall quality of health information obtained from Chinese websites about scaphoid fracture was very low, suggesting that patients and their family members should be aware such deficiency and pay special attentions for the medical information obtained by using the current search engines in China.


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