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Effect of Benson's relaxation technique versus music intervention on physiological parameters and stress of children with thalassemia during blood transfusions: A randomized controlled trial
Badr, E. A., Ibrahim, H., Saleh, S. E.
Journal of pediatric nursing. 2023
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Editor's Choice
Abstract
BACKGROUND Children with thalassemia are generally dependent on blood transfusions and face a lot of stress and alteration in their physiological parameters through the procedure. AIM: This study aimed to investigate the effect of Benson's relaxation technique versus music intervention on physiological parameters and stress of children with thalassemia during blood transfusions. DESIGN A randomized, controlled trial with three parallel groups. METHODS One hundred and twenty preschool-age children with thalassemia who underwent blood transfusions were randomly assigned to three groups. Children of the control group received only routine hospital care through blood transfusions. Music intervention group children listened to recorded Mozart's music and children of Benson's relaxation group received relaxation intervention before and during the blood transfusions. Outcome measures were physiological parameters and behavioral distress levels. SETTING Hematology outpatient clinic of the Children's University Hospital at El-Shatby in Alexandria from October 2022 to February 2023. RESULTS The mean total score of children's behavioral responses to stress before the blood transfusions procedure was 19.32 ± 4.08, 14.20 ± 0.93, and 16.92 ± 4.74 in the control, music, and Benson groups, respectively. Beyond that, there was a decline in their physiological parameters and behavioral stress response during and after procedure among groups of study (P = 0.005 & <0.001, respectively). CONCLUSION Music and Benson's relaxation interventions had a helpful effect on stabilizing the physiological parameters and reducing behavioral distress levels in children with thalassemia undergoing blood transfusions. PRACTICE IMPLICATIONS This study directs paediatric nurses to apply Benson's relaxation and music interventions for children with thalassemia to enhance their responses.
PICO Summary
Population
Preschool-age children with thalassemia who underwent blood transfusions (n= 120).
Intervention
Benson’s relaxation technique intervention (n= 40).
Comparison
Mozart's music intervention (n= 40); routine hospital care (n= 40).
Outcome
The mean total score of children's behavioral responses to stress before the blood transfusions procedure was 19.32 ± 4.08, 14.20 ± 0.93, and 16.92 ± 4.74 in the control, music, and Benson groups, respectively. Beyond that, there was a decline in their physiological parameters and behavioral stress response during and after procedure among groups of study.
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Estimating Bleeding Risk in Patients with Cancer-Associated Thrombosis: Evaluation of Existing Risk Scores and Development of a New Risk Score
de Winter MA, Dorresteijn JAN, Ageno W, Ay C, Beyer-Westendorf J, Coppens M, Klok FA, Moustafa F, Riva N, Ruiz Artacho PC, et al
Thrombosis and haemostasis. 2021
Abstract
BACKGROUND Bleeding risk is highly relevant for treatment decisions in cancer-associated thrombosis (CAT). Several risk scores exist, but have never been validated in patients with CAT and are not recommended for practice. OBJECTIVES To compare methods of estimating clinically relevant (major and clinically relevant nonmajor) bleeding risk in patients with CAT: (1) existing risk scores for bleeding in venous thromboembolism, (2) pragmatic classification based on cancer type, and (3) new prediction model. METHODS In a posthoc analysis of the Hokusai VTE Cancer study, a randomized trial comparing edoxaban with dalteparin for treatment of CAT, seven bleeding risk scores were externally validated (ACCP-VTE, HAS-BLED, Hokusai, Kuijer, Martinez, RIETE, and VTE-BLEED). The predictive performance of these scores was compared with a pragmatic classification based on cancer type (gastrointestinal; genitourinary; other) and a newly derived competing risk-adjusted prediction model based on clinical predictors for clinically relevant bleeding within 6 months after CAT diagnosis with nonbleeding-related mortality as the competing event ("CAT-BLEED"). RESULTS Data of 1,046 patients (149 events) were analyzed. Predictive performance of existing risk scores was poor to moderate (C-statistics: 0.50-0.57; poor calibration). Internal validation of the pragmatic classification and "CAT-BLEED" showed moderate performance (respective C-statistics: 0.61; 95% confidence interval [CI]: 0.56-0.66, and 0.63; 95% CI 0.58-0.68; good calibration). CONCLUSION Existing risk scores for bleeding perform poorly after CAT. Pragmatic classification based on cancer type provides marginally better estimates of clinically relevant bleeding risk. Further improvement may be achieved with "CAT-BLEED," but this requires external validation in practice-based settings and with other DOACs and its clinical usefulness is yet to be demonstrated.
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Use of electronic self-administered bleeding assessment tool in diagnosis of paediatric bleeding disorders
Kaur D, Kerlin BA, Stanek JR, O'Brien SH
Haemophilia : the official journal of the World Federation of Hemophilia. 2021
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Free full text
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Editor's Choice
Abstract
INTRODUCTION In the era of electronic medical records, pen-and-paper-based physician-administered bleeding assessment tools (BAT) remain under-utilized in the clinical setting, as they are noted to be time-consuming. AIM: The current study reviews the use of an electronic self-administered bleeding assessment tool (eBAT) prospectively in a paediatric haematology clinic and in comparison with a physician administered BAT (pBAT). MATERIALS AND METHODS This was reviewed and approved in the current form because the aims statement includes the method regarding comparison of 2 groups. So no additional section required. RESULTS A total of 94 BAT response pairs were available for analysis. The median time required for patients or parents to complete the eBAT was 8 min, with less than a third of the patients requiring over 10 min. The median bleeding scores noted in this study were 4 for both the BATs, with strong positive correlation between the eBAT and the physician administered bleeding questionnaire. The eBAT had a sensitivity of 93.8% (95% CI 82.8%-98.7%), a specificity of 34.8% (95% CI 21.4%-50.3%), a positive predictive value (PV) of 60.0% (95% CI 54.5%-65.2%) and a negative PV of 84.2% (95% CI 62.5%-94.5%) for identifying a bleeding disorder. CONCLUSIONS Findings indicate that eBAT is a valid and time-efficient screening tool for evaluating patients' bleeding symptoms, which can improve clinical applicability of BATs by reducing time for bleeding history review.
PICO Summary
Population
Paediatric haematology patients (n=94).
Intervention
Electronic self-administered bleeding assessment tool (eBAT), (n= 94).
Comparison
Physician administered BAT (pBAT), (n= 94).
Outcome
The median time required for patients or parents to complete the eBAT was 8 min, with less than a third of the patients requiring over 10 min. The median bleeding scores noted in this study were 4 for both the BATs, with strong positive correlation between the eBAT and the physician administered bleeding questionnaire. The eBAT had a sensitivity of 93.8%, a specificity of 34.8%, a positive predictive value (PV) of 60.0%, and a negative PV of 84.2% for identifying a bleeding disorder.
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Weekly epistaxis duration as an indicator of epistaxis severity in hereditary hemorrhagic telangiectasia-Preliminary results from a randomized controlled trial
Wu V, Lee JM, Vozoris NT, Faughnan ME
Laryngoscope investigative otolaryngology. 2021;6(3):370-375
Abstract
OBJECTIVES There is great interest in developing and studying novel therapies for epistaxis in hereditary hemorrhagic telangiectasia (HHT) given its associated morbidity and impact on patients' quality of life. Several recent randomized controlled trials (RCTs) have been negative, likely attributed to poorly characterized outcome measures. This study reported on and evaluated an epistaxis outcome measure, weekly epistaxis duration (WED) in an ongoing RCT, with the aim of better characterizing the measurement of epistaxis for clinical trials. MATERIALS AND METHODS Patients were recruited to an ongoing phase II, double-blind, cross-over RCTs of oral doxycycline for HHT-associated epistaxis. Patients were included for the epistaxis measures analysis if they had already completed the initial 3-month run-in period, and had received treatment of either study drug doxycycline or placebo for a minimum of 6 months. The primary measure of interest was patient-reported outcome (PRO)-WED, captured from prospective daily diaries. Epistaxis severity score (ESS) was collected as a secondary outcome. RESULTS Seven patients were included for analysis, with 98% completion of the daily diary. The average PRO-WED across all patients was 85.0 minutes, SD 93.2 at baseline, and 65.6 minutes, SD 59.5 during treatment/placebo. Coefficient of variance for PRO-WED at baseline and during treatment/placebo was 0.49, SD 0.1 and 0.58, SD 0.2, respectively. Statistically significant changes in the mean PRO-WED from baseline to treatment/placebo was noted in six patients (86%). Only two patients (29%) had a significant change in ESS, with both reporting decreased (improved) scores after treatment/placebo as compared to baseline. CONCLUSIONS PRO-WED was a feasible clinical trials measure, was reasonably stable during baseline measurement, and appeared to be variable with treatment state, suggesting it may provide a sensitive clinical trials PRO in HHT.
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Exploring the components of bleeding outcomes in transfusion trials for patients with hematologic malignancy
Balitsky AK, Liu Y, Van der Meer PF, Heddle NM, Arnold DM
Transfusion. 2020
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Editor's Choice
Abstract
Clinically significant bleeding in patients with hematologic malignancies is a heterogeneous composite outcome currently defined as World Health Organization (WHO) bleeding Grades 2, 3, and 4. However, the clinical significance of some minor bleeds categorized as WHO Grades 1 and 2 remains controversial. We analyzed the number and frequency of individual signs and symptoms of WHO Grades 1 and 2 bleeds and explored their association with more severe incident bleeds graded as WHO Grades 3 and 4. STUDY DESIGN AND METHODS We aggregated daily bleeding assessment data from three randomized controlled trials conducted in patients with hematologic malignancies that used bleeding as an outcome. Cox proportional hazard regression analysis was used to identify signs and symptoms categorized as WHO Grades 1 and 2 bleeds that were associated with more severe bleeds (Grades 3 and 4). RESULTS We collected data from 315 patients (n = 5476 daily bleeding assessments; 3383 [61.8%] with a bleed documented). A total of 98.3% (3326/3383) were Grade 1 and 2 bleeds and 1.7% (57/3383) were Grades 3 and 4. Grade 1 and 2 bleeds were composed of 20 different bleeding signs and symptoms. Hematuria (hazard ratio, 16.1; 95% confidence interval, 4.4-59.2; P < .0001) was associated with incident Grade 3 or 4 bleeds. CONCLUSION In patients with hematologic malignancy, only hematuria (microscopic and/or macroscopic) was associated with more severe incident bleeds. This findings require validation in independent data sets.
PICO Summary
Population
Patients with haematologic malignancies and chemotherapy-induced thrombocytopenia (3 randomised controlled trials (RCTs), n= 315).
Intervention
Less severe bleeds (WHO Grades 1 and 2).
Comparison
More severe bleeds (WHO Grades 3 and 4).
Outcome
The total data aggregated from the 3 RCTs was 5,476 daily bleeding assessments, 61.8% with a bleed documented. A total of 98.3% were Grade 1 and 2 bleeds and 1.7% were Grades 3 and 4. Grade 1 and 2 bleeds were composed of 20 different bleeding signs and symptoms. Haematuria was associated with incident Grade 3 or 4 bleeds. In patients with haematologic malignancy, only haematuria was associated with more severe bleeds.
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Clinical Pharmacist-Provided Services In Iron-Overloaded Beta-Thalassaemia Major Children: A New Insight Into Patient Care
Bahnasawy SM, El Wakeel LM, Beblawy NE, El-Hamamsy M
Basic & Clinical Pharmacology & Toxicology. 2017;120(4):354-359
Abstract
Iron-overloaded β-thalassaemia major (BTM) children have high risk of delayed sexual/physical maturation, liver/heart diseases and reduced life expectancy. The lifelong need to use iron chelators, their unpleasant administration, side effects and lack of awareness regarding iron overload risks all hamper BTM patient compliance to iron chelators. This study evaluated the impact of clinical pharmacist-provided services on the outcome of iron-overloaded BTM children. Forty-eight BTM children were randomly assigned to either control group, who received standard medical care, or intervention group, who received standard medical care plus clinical pharmacist-provided services. Services included detection of drug-related problems (DRPs) and their management, patient education regarding disease nature and iron chelators, as well as providing patient-tailored medication charts. After six months of study implementation, there was a highly significant difference between the control and intervention groups in serum ferritin (SF) (mean: 3871 versus 2362, μg/l, p = 0.0042), patient healthcare satisfaction (median: 24.47 versus 90.29, p < 0.0001) and quality of life (QoL) (median: 49.84 versus 63.51, p = 0.0049). The intervention group showed a decline from baseline to the end of study in DRPs (64-4), the number of non-compliant patients (24-3) and mean SF levels (3949-2362 μg/l, p < 0.0001). Clinical pharmacist-provided services can positively impact the outcome of BTM children.
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Thromboelastographic follow-up of prophylactic thrombocyte transfusion
Sahin DG, Akay OM, Karagulle M, Gunduz E, Gulbas Z
Blood. 2013;122((21):):4826.
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Intra-patient variability of thromboelastographic parameters following in vivo and ex vivo administration of recombinant activated factor VII in haemophilia patients. A multi-centre, randomised trial
Kenet G, Stenmo CB, Blemings A, Wegert W, Goudemand J, Krause M, Schramm W, Kirchmaier C, Martinowitz U
Thrombosis and Haemostasis. 2010;103((2):):351-9.
Abstract
Thromboelastography methods have been used to predict or monitor treatment of haemophilia patients with recombinant activated factor VII (rFVIIa). However, neither of the two thromboelastographic methods (ROTEM and TEG) has as yet been validated. This multi-centre, randomised trial compared both methods in terms of intra- and inter- patient variability following in vivo and ex vivo rFVIIa administration to haemophilia A and B patients with and without inhibitors. Patients ((3)16 years old) received the same intravenous rFVIIa dose (45, 90 or 180 microg/kg) twice, 1-12 weeks apart. Blood samples were collected pre-dose and 15, 60, 120 and 240 minutes post-dose for ROTEM and TEG analysis. Pre-dose samples were also spiked ex vivo with rFVIIa (0. 6, 1. 2 or 2. 4 microg/ml), to correspond to the three in vivo doses. Twenty-six haemophilia A and four haemophilia B patients were enrolled. A significant treatment effect was observed with in vivo rFVIIa (p<0. 05) with more pronounced effects in inhibitor (n=14) versus non-inhibitor (n=16) patients. There was a strong positive correlation between ROTEM and TEG parameters. Intra- and inter-patient variation was large for all thromboelastography parameters at all time points and rFVIIa doses. Intra-patient variation was generally lower for non-inhibitor than inhibitor patients, and lower following ex vivo spiking versus in vivo rFVIIa administration. In conclusion, there was a clear effect of rFVIIa on all thromboelastography parameters, but the large intra- and inter-patient variability following in vivo rFVIIa administration renders the use of our method unsuitable for dose-response prediction for haemophilia patients in the clinical setting.
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Factor concentrate tracking in haemophilia home therapy: a randomized trial (RCT)
Heddle N
Vox Sanguinis. 2004;87((Suppl 3):):11. Abstract No. Tu08.06.
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The effects of infusion methods on platelet count, morphology, and corrected count increment in children with cancer: in vitro and in vivo studies
Norville R, Hinds P, Wilimas J, Fairclough D, Fischl S, Kunkel K
Oncology Nursing Forum. 1994;21((10):):1669-73.
Abstract
PURPOSE/OBJECTIVES To determine whether infusion method influences the quality of platelets transfused. DESIGN Linked in vitro and in vivo study. Quasi-experimental design for in vitro and cross-over design with balanced randomization for in vivo. SETTING Pediatric cancer center in the midsouthern United States. SAMPLE Pheresed/pooled platelet units in vitro (n = 12). In vivo convenience sample of 26 children, ages 2-19 years, with cancer and thrombocytopenia who required platelet transfusion. METHODS Two infusion pumps (IMED 980 and Gemini, IMED Corp., San Diego, CA) versus gravity flow for in vitro platelet infusion. Gemini infusion pump versus gravity flow for in vivo platelet transfusion. MAIN OUTCOME MEASURES Platelet count, morphology score, and corrected count increment. FINDINGS No significant differences noted in platelet count or morphology score among or across the three infusion methods in vitro. No significant differences noted between the two infusion methods in platelet count or corrected count increment in vivo. CONCLUSIONS Although limited to a specific patient population, setting, and infusion device, findings revealed that the pump was clinically acceptable because it did not negatively affect platelet recovery. Replication of this study with other infusion devices is recommended. IMPLICATIONS FOR NURSING PRACTICE Study findings validate the current nursing procedure for the administration of platelets at the study setting. Use of infusion pumps for platelet transfusions is time-efficient and energy-efficient for nurses because the pumps offer a well-controlled infusion rate, accurate volume measurement, and an alarm system for monitoring the infusion.