Lack Of Anti-Xa Assay Standardization Results In Significant Dose Variation In Neonates and Children Receiving Enoxaparin

Blood ◽  
2013 ◽  
Vol 122 (21) ◽  
pp. 2379-2379
Author(s):  
Lindsey A. Greene ◽  
Connie Law ◽  
Mike Jung ◽  
Sara Walton ◽  
Leslie J. Raffini
Keyword(s):  
Conflicts Of Interest ◽  
Median Number ◽  
Therapeutic Monitoring ◽  
Dose Titration ◽  
Controlled Clinical Trial ◽  
Cumulative Number ◽  
Significant Difference ◽  
Pharmacokinetic Properties ◽  
The Mean ◽  
Dose Variation

Abstract Introduction Due to favorable pharmacokinetic properties, enoxaparin is the most frequently used anticoagulant in children. Unlike adults, a developing hemostatic system provides rationale for therapeutic monitoring with an anti-Xa goal of 0.5-1 units/ml. However, accepted therapeutic ranges are not well correlated with clinical outcomes (i.e. thrombosis or hemorrhage) and there is no assay standardization. In 2011 the coagulation laboratory at the Children's Hospital of Philadelphia (CHOP) changed anti-Xa laboratory assays resulting in anti-Xa levels that were on average, 33% higher than the prior assay (Figure 1). We describe how this change in assay influenced therapeutic enoxaparin dose (mg/kg) at our center. Methods The coagulation laboratory performed simultaneous anti-Xa measurements using the Stachrom (old) assay and Rotachrom (new) assay on 19 subjects from split plasma samples. The new assay was then implemented into clinical practice. Information on anti-Xa values and enoxaparin dosing during the initiation of anticoagulation was retrospectively compiled for the 6 months pre and post assay change. Data on enoxaparin dosing and anti-Xa values was collected on 109 children in the old assay phase and 104 children in the new assay phase. Therapeutic enoxaparin dose was defined as the first dose resulting in an anti-Xa value 0.5- 1 unit/ml. All subjects initiated on anticoagulation during this 12 month period were included. Anti-Xa levels were obtained per CHOP standard clinical monitoring: until therapeutic, after dose adjustment, and every other week while inpatient with some subjects more frequently evaluated per provider discretion. Cumulative number of inpatient anti-Xa values obtained was determined for each subject. Enoxaparin dosing and cumulative anti-Xa values pre and post assay changes in each cohort were analyzed using a t-test. Results Using 19 split samples there was strong correlation between the two assays (r=0.96), however, the means between the two assays differed significantly (p <0.0001) with new assay findings being, on average, 33% higher (Figure 1). There was a significant decrease in the new assay mean therapeutic enoxaparin dose (mg/kg) in subjects <3 months (p=0.01) and 3 months–2 years (p<0.0001), but not in subjects >2 years (p=0.18) (Table 1). However, the mean first therapeutic anti-Xa value was significantly higher in subjects > 2 yrs post-assay change (p=0.001). Among all 213 subjects, a total of 1,061 inpatient anti-Xa values were obtained, with a median of 3 (range: 1-32) per subject. Median number of anti-Xa values obtained to achieve therapeutic range was 2 (range: 1-6) prior to assay change and 1 (range: 1-7) post assay change with a significant difference (p=0.004) observed between the groups. Conclusions Using split patient samples, the Rotachrom assay demonstrated significantly higher anti-Xa values than the Stachrom assay. Once the Rotachrom assay was clinically implemented, there was a significant difference in weight based enoxaparin dosing in subjects < 2 years, and higher anti-Xa levels in subjects > 2 yrs. These observations demonstrate enoxaparin dose titration to achieve therapeutic anti-Xa is vulnerable to assay variability. Since these assays are not well standardized, this practice is likely to provide false reassurance of efficacy and safety. The large number of anti-Xa levels obtained may represent unnecessary venipuncture as well as misappropriation of time and resources. It is possible the majority of neonates and children may be safely and effectively treated with weight based dosing without monitoring. These data support a randomized controlled clinical trial in neonates and children comparing safety and efficacy of enoxaparin weight based dosing to dosing titrated to achieve therapeutic anti-Xa. Disclosures: No relevant conflicts of interest to declare.

scholarly journals THU0517 THE ROLE OF ULTRASOUND-DEFINED SYNOVITIS GRADE I IN PATIENTS PRESENTING WITH INFLAMMATORY ARTHRALGIA, A RETROSPECTIVE STUDY

2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 497.2-497
Author(s):  
J. Arroyo Palomo ◽  
M. Arce Benavente ◽  
C. Pijoan Moratalla ◽  
B. A. Blanco Cáceres ◽  
A. Rodriguez
Keyword(s):  
Rheumatoid Arthritis ◽  
Inflammatory Arthritis ◽  
Statistical Tests ◽  
Median Number ◽  
Painful Joint ◽  
Significant Difference ◽  
The Mean ◽  
Specialized Unit

Background:Musculoeskeletal ultrasound (MSUS) is frequently used in several rheumatology units to detect subclinical inflammation in patients with joint symptoms suspected for progression to inflammatory arthritis (IA). Synovitis grade I (EULAR-OMERACT combined score) is known to be a casual finding in healthy individuals, but studies headed to unravel its possible role on rheumatic diseases are sparse.Objectives:To investigate the correlation between synovitis grade I, and the diagnosis of IA made after a year follow-up period since MSUS findings, in patients of an MSUS-specialized unit of a Rheumatology Department.Methods:We conducted a descriptive, retrospective and unicentric study. 30 patients were selected from the MSUS-specialized unit of our Rheumatology Department from July-18 to January-19. Patients presenting synovitis grade 0 (exclusively), 2 and/or 3 on combined score were excluded. Data collection at baseline included age, sex, immunological profile and previous physical examination to the MSUS findings, as well as the diagnosis made by the rheumatologist in 1-year visit follow-up: dividing the patient sample into two groups: those who were diagnosed with IA and those not. Non-parametric statistical tests for comparing means were used.Results:The mean age was 51,6 years and 70% were females. 6 (20%) patients were diagnosed with inflammatory arthritis after a year follow-up: 2 (4,8%) psoriatic arthritis, 1 (3,3%) undifferentiated arthritis, 1 (3,3%) rheumatoid arthritis, 1 (3,3%) Sjögren’s syndrome. Non-inflammatory arthropathies were also found 24 (80%), of which, 12 (40%) were non-specific arthralgias and 8 (19%) osteoarthritis.In the group of patients who did not developed an IA the mean C-reactive protein (CPR) value was 3,12 mg/L and erythrocyte sedimentation rate (ESR) was 8,2 mm; all of them were rheumatoid factor (RF) positive and ACPA-negative except one patient. 5 (31,3%) patients presented low antinuclear antibodies (ANAs) levels. In those who HLA B-27 and Cw6 were tested (4,25%); both were negative except for one that was HLA B-27 positive. The median number of swollen and painful joint count was 0, and the mean of joints with MSUS involvement was 3,5; the mean involved metacarpophalangeal (MCP) joints was 1,83; proximal interphalangeal (PIP) joints was 1,48 and distal interphalangeal (DIP) joints 0,21.Among the group of patients that developed an IA the mean of CPR and ESR was 9,27 mg/L and 14,17 mm respectively; 2 (33%) patients were RF- positive, and 1 ACPA-positive. ANAs were positive in 3 cases (50%). The median of swollen joint count was 2 and for painful joint count was 0, the median of joints with MSUS involvement was 4,5. The mean of MSUS involvement was for MCP, PIP and DIP joints: 1,67, 2 and 0. Comparing the means of CPR values in the two groups with Student’s t-test we obtained a statistically significant difference (p=0,023). No other significant differences were found.Conclusion:Despite the limitations and possible statistical bias, the presence of MSUS-defined synovitis grade I and elevated CRP levels could be related to further diagnoses of inflammatory arthropathy. Besides, the absence of synovitis in DIP joints might have a diagnostic role. Normal physical exploration and normal levels of CRP might suggest low MSUS value. However, further research is needed to clarify the role of MSUS-defined synovitis grade I.References:[1]D’Agostino MA et al. Scoring ultrasound synovitis in rheumatoid arthritis: a EULAR-OMERACT ultrasound taskforce-Part 1: definition and development of a standardized, consensus-based scoring system. RMD Open. 2017;3(1):e000428.[2]Van den Berg R et al. What is the value of musculoskeletal ultrasound in patients presenting with arthralgia to predict inflammatory arthritis development? A systematic literature review. Arthritis Research & Therapy (2018) 20:228.Disclosure of Interests:None declared

Hodgkin Lymphoma Outcomes: Can We Expect Ethnic Parity in a Hispanic Prevalent Population?

Blood ◽  
2019 ◽  
Vol 134 (Supplement_1) ◽  
pp. 4056-4056
Author(s):  
Michelle Janania Martinez ◽  
Prathibha Surapaneni ◽  
Juan F Garza ◽  
Tyler W Snedden ◽  
Snegha Ananth ◽  
...  
Keyword(s):  
Hodgkin Lymphoma ◽  
Conflicts Of Interest ◽  
Relative Survival ◽  
Complete Response ◽  
Statistical Testing ◽  
P Value ◽  
Hispanic Population ◽  
Significant Difference ◽  
The Mean

BACKGROUND It is estimated that 8110 persons will be diagnosed with Hodgkin Lymphoma (HL) in the US during 2019, but the advent of new treatment options has increased the cure rate to at least 80%. It has been reported that the rates of HL are lower in the adolescent and young adult (AYA) Hispanic population but significantly higher in the Hispanic population older than 65. The relative survival estimates are stated to be similar between AYA Hispanics (HI) and non-Hispanics (NH) but for ages 65-84, HI have a significantly higher mortality rate. Pediatric studies have suggested that ethnicity plays a role in outcomes in patients with HL but there is limited data in the adult population. There is an unmet need in the field, where dossiers on underrepresented ethnic minorities need to be carefully considered and compared to existing data. Therefore, our study aims to compare survival outcomes in Hispanics vs Non-Hispanics with HL, who were treated at the only NCI designated cancer center of South Texas. To our knowledge this is the largest cohort of HL patients from a single academic institution that serves primarily Hispanics. METHODS We located and retrospectively analyzed a total of 616 patients with diagnosis of Lymphoma (HL and NHL) by International Classification of Diseases (ICD) codes and identified 116 cases of HL; all the patients received care at UT Health San Antonio, between 2008-2018. Key variables for each patient included age, gender, race/ethnicity, comorbidities, insurance status, stage, BM and extranodal involvement, treatment received, outcome at 3 and 5 years and vitality status in 2018. Continuously distributed outcomes were summarized with the mean and standard deviation and categorical outcomes were summarized with frequencies and percentages. The significance of variation in the mean with disease category was assessed with one way ANOVA and the significance of associations between categorical outcomes was assessed with Pearson's Chi Square or Fisher's Exact test as appropriate. Multivariate logistic regression was used to model binary outcomes in terms of covariates and indicators of disease. All statistical testing was two-sided with a significance level of 5%. R1 was used throughout. The study was approved by the local Institutional Review Board. The findings will be available to patients, funders and medical community through traditional publishing and social media. RESULTS We identified 116 patients with HL, of which 73 were HI (63%), 43 NH (36%) and 1 not specified (1%). In regard to race, 92% identified as Caucasian, 4% as African American, 3% other and 1% Asian. The median age at diagnosis was 37.4, (SD 15.13). There were 49 females (42%) and 67 males (58%). The most common funding source was commercial insurance N=54 (47%), followed by a hospital payment plan N=30 (26%), Medicare N=16 (14%), unfunded N=13 (11%) and Medicaid N=3 (2%). Most prevalent co-morbidities were HTN N=28 (24%) and diabetes mellitus N= 23(20%); 50% of patients had no co-morbidities (N=63).At diagnosis ECOG of 0-1 was seen in 108 patients (93%); 8 were Stage I (7%), 39 stage II (33%), 32 stage III (28%), and 37 stage IV (32%). EBV was positive in 26 patients (22%). There were 15 patients that were HIV positive (13%), 54% with CD4 count <200, and 12 (75%) on antiretroviral therapy at diagnosis. Median PFS was 853.85 days (SD 912.92). We excluded patients who were lost to follow up or had not reached 3/5 years. At 3 year follow up there was: complete response in 37 HI (74%) vs 22 NH (92%); disease progression in 8 (16%) vs 0 (0%); death in 5 (10%) vs 2 (8%), respectively (p-value= 0.094). At 5 year follow up there was: complete response in 30 HI (77%) vs 17 NH (90%); progressive disease in 2 (5%) vs 0 (0); death 7 (18%) vs 2 (11%), respectively (p-value = 0.619). At the end of 2018, 41 HI (84%) were alive compared to 22 NH (88%) [p-value 0.74]. CONCLUSION Within the limitations of sample size, our study demonstrates that in the prevalently Hispanic population of our institution, HI patients with HL have no statistically significant difference in outcome when compared to NH patients. Disclosures No relevant conflicts of interest to declare.

Platelet Delta Granule and Serotonin Concentrations Are Decreased in Patients with Postural Orthostatic Tachycardia Syndrome.

Blood ◽  
2009 ◽  
Vol 114 (22) ◽  
pp. 2419-2419
Author(s):  
Lisa Rinker ◽  
Nicole Zadzilka ◽  
Mohammad K Kanjwal ◽  
Beverly Karabin ◽  
Kathryn Boehm ◽  
...  
Keyword(s):  
Nervous System ◽  
Selective Serotonin Reuptake Inhibitors ◽  
Conflicts Of Interest ◽  
Orthostatic Intolerance ◽  
Postural Orthostatic Tachycardia Syndrome ◽  
Serotonin Level ◽  
Control Subjects ◽  
Storage Pool ◽  
Significant Difference ◽  
The Mean

Abstract Abstract 2419 Poster Board II-396 Syncope is generally defined as a state of temporary, partial or complete, loss of consciousness (fainting) with spontaneous recovery. The basis for the phenomenon is complex and includes a variety of orthostatic intolerance conditions including neurocardiogenic syncope (NCS), postural orthostatic tachycardia syndrome (POTS), and other disorders affecting the autonomic nervous system. NCS patients and POTS patients can be differentiated with an upright tilt test because either bradycardia or tachycardia will occur with hypotension, respectively. Both are induced by the inability to maintain adequate systemic blood pressure. Though the two primary types of syncope are different in origin, both conditions are treated similarly. Recent reports suggest that syncope is a low serotonin (5HT) disorder and selective serotonin reuptake inhibitors (SSRIs) are a commonly prescribed treatment for both NCS and POTS patients. The major storage pool of serotonin, independent of the central nervous system, is contained in platelet dense granules (DG). Peripheral serotonin aids in vasoconstriction and blood clotting. Individuals prone to syncope may be deficient in serotonin. Insufficient peripheral serotonin may create conditions that lead to hypotension and excessive bleeding in an individual. We previously reported that patients having episodes of syncope (Blood, 112(11):451, 2008) had statistically significant decreases of DG/PL, consistent with DG storage pool deficiency (δSPD), and PL 5HT concentrations when compared to control subjects. Our test subjects were screened by questionnaire to determine syncope and distinction between NCS and POTS was not considered. These patients had an average of 3.08 ± 0.52 DG/PL and a mean 5HT concentration of 248.40 ± 37.94 ng/109 PL (PL 5HT normal range = 215-850 ng/109 PL). Control subjects (n=24) had an average of 4.22 ± 0.12 DG/PL and a 5HT concentration of 666.54 ± 56.25; both values having a significant difference (p=.003 and p<.001) by a Mann-Whitney Rank Order test respectively. We now report the DG/PL and 5-HT values obtained exclusively from patients diagnosed with POTS by tilt-table assessment and compared with control subjects. Patients for this study were obtained from our cardiology clinic and all were positive for POTS; they were not currently taking or were recently prescribed a SSRI for therapeutic management of their condition. Control subjects did not have syncope or history of bleeding. Peripheral blood was collected and PLs obtained via centrifugation to determine the mean DG/PL by electron microscopy and the mean 5HT concentration extracted from PLs using an ELISA technique. POTS patients (n=14) had a mean serotonin level of 326.6 ± 76.7 ng/109 PL compared to 589.6 ± 56.3 ng/109PL (p<0.004) for control subjects (n=21). POTS patients exhibited a mean of 2.6 ± 0.31 DG/PL compared to the control subject value of 4.16 ± 0.09 DG/PL (p<0.001). To date there is no significant difference in the number of PL DG or 5HT levels POTS patients compared to our previous evaluation of undefined syncope patients. These results support the hypothesis that syncope (NCS and POTS) may be the result of low peripheral serotonin levels. Our preliminary data demonstrates that POTS patients have low serotonin levels and δSPD when compared to control subjects. This study is ongoing to increase the total number of POTS patients enrolled as well as to recruit subjects diagnosed with NCS to determine whether a difference in DG and/or 5HT exists to explain either bradycardia or tachycardia as an early symptom in the development of hypotension. Disclosures: No relevant conflicts of interest to declare.

Study of Renal Iron Overload by T2* MRI in a Large Cohort of Thalassemia Major Patients

Blood ◽  
2012 ◽  
Vol 120 (21) ◽  
pp. 5177-5177
Author(s):  
Antonella Meloni ◽  
Daniele De Marchi ◽  
Vincenzo Positano ◽  
Gaetano Giuffrida ◽  
Sabrina Armari ◽  
...  
Keyword(s):  
Iron Overload ◽  
Conflicts Of Interest ◽  
Left Kidney ◽  
Significant Negative Correlation ◽  
Thalassemia Major ◽  
Iron Deposition ◽  
Significant Difference ◽  
The Mean ◽  
The Right ◽  
T2 Mri

Abstract Abstract 5177 Background. Renal dysfunction has been reported in adult subjects with thalassemia major (TM) since 1975. One of the main cause is the iron overload consequent to regular transfusions. Multiecho T2* MRI is a well-established technique for cardiac and hepatic iron overload assessment, but there very few report concerning the kidneys. The aims of this study were to describe the T2* values of the kidneys in patients with TM, to investigate the correlation between renal and myocardial or hepatic siderosis and biventricular cardiac function. Methods. 119 TM patients (58 men, 30. 7 ± 8. 2 years) enrolled in the Myocardial Iron Overload (MIOT) networks underwent MRI. For the measurement of iron overload, multiecho T2* sequences were used. The left ventricle was segmented into a 16-segments standardized model and the T2* value on each segment was calculated as well as the global value. In the liver, the T2* value was assessed in a single region of interest (ROI) in a homogeneous area of the parenchyma. For each kidney, T2* values were calculated in three different ROIs and were averaged to obtain a representative value for the kidney. The mean T2* value over the kidneys was also calculated. Cine images were obtained to quantify biventricular morphological and functional parameters in a standard way. Results. T2* values in the right kidney were significant lower than in the left kidney (40. 3±11. 9 ms vs 44. 1±12. 7 ms, P<0. 0001). The mean T2* value over the kidneys was 42. 2±11. 9 ms and 40 patients (33. 6%) had a pathological value (T2*<36 ms, lower limit of normal evaluated on 20 healthy subjects). The mean T2* value did not show a significant difference amongst men ad women (43. 2±11. 7 ms versus 41. 3±12. 1 ms, P=0. 378). The mean T2* values increased with age in a significant manner (r=0. 321, P<0. 0001). There was a significant negative correlation between serum ferritin levels and mean renal T2* values (r=-0. 446, P<0. 0001). Significant positive correlations of the mean T2* values were demonstrated for liver (r=0. 511, P<0. 0001) and global heart (r=0. 262, P=0. 004) T2* values (Figure 1). No correlation was found between renal iron overload and bi-ventricular function parameters. Conclusions. Systemic T2* differences between left and right kidneys were found, with significant lower values in the right one. Mean T2* value increased with age. We confirmed that kidney iron deposition was not very common in TM, but it was correlated with iron deposition in liver and heart. Disclosures: No relevant conflicts of interest to declare.

scholarly journals Randomized Controlled Clinical Trial Comparing Transurethral Eneucleation and Resection of Prostate and Trans-urethral Resection of Prostate in the Management of Benign Prostatic Hyperplasia

2017 ◽  
Vol 7 (3) ◽  
pp. 216-220
Author(s):  
Md Mehedi Hasan ◽  
Samira Rahat Afroze ◽  
Muhammad Abdur Rahim ◽  
Muhammad Abdus Salam
Keyword(s):  
Controlled Trial ◽  
Ethical Review ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Transurethral Resection Of Prostate ◽  
Randomized Controlled ◽  
Significant Difference ◽  
Group A ◽  
The Mean ◽  
Group B

Background: Transurethral resection of prostate (TURP) is the predominant surgical procedure for benign prostatic hypertension (BPH) but is not devoid of complications like capsular perforation, drop in Hb%, drop in Na+, residual adenoma; hence endeavors are evolving to combat such complications. A newer technique transurethral enucleation and resection of prostate (TUERP) has been devised to solve these problems. This study was designed to compare the safety and the efficacy of newer technique, TUERP with widely practiced TURP Methods: This randomized controlled trial was done at BSMMU, after getting ethical approval from the ethical review committee of the institute, from January to October, 2009. A total of 60 BPH patients were purposively enrolled in this study, after obtaining informed written consent and they were randomized as control, Group A (30 patients, underwent TURP) and experimental group, Group B (30 patients, underwent TEURP).Results: The mean preoperative Hb% level of Group A was 15.1 gm% (SD ± 0.5) and perioperative Hb% level was 13.04 gm% (SD ± 6.06). There was significant difference (P <0.05). The mean preoperative Hb% of Group B was 15.2 gm% (SD ± 0.5) and perioperative Hb% was 15.2 gm% (SD ± 0.48). There was no difference (P >0.05). The mean preoperative Na + of Group A was 140 mmol/l (SD ± 4.1) and perioperative Na+ was 126 mmol/l (SD ± 6.8). There was significant difference (P<0.01). The mean preoperative Na+ of Group B was 136 mmol/l (SD ± 4) and perioperative Na+ was 136 mmol/l (SD ± 2.70). There was no difference (P >0.05).Conclusion: TUERP eliminates drop in Hb% and Na+which are usual consequences following TURP. Thus TUERP can be advocated in the treatment of BPH as it also allows completeresection down to surgical capsule.Birdem Med J 2017; 7(3): 216-220

scholarly journals The effect of delivery ball and warm shower on the childbirth experience of nulliparous women: A randomized controlled clinical trial

2021 ◽  
Author(s):  
parvaneh sharifipour ◽  
Masoomeh Kheirkhah ◽  
Mojgan Rajati ◽  
hamid haghani
Keyword(s):  
Clinical Trial ◽  
Pregnant Women ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Control Groups ◽  
Childbirth Experience ◽  
Nulliparous Women ◽  
Significant Difference ◽  
The Mean ◽  
And Control

Abstract Background Childbirth is a unique experience that affects women’s life. Therefore, this study was performed to determine the effect of delivery ball and warm shower on the childbirth experience of primiparous women. Methods This study is a clinical trial that was carried out on primiparous pregnant women referred to Motazedi Hospital in Kermanshah, Iran. Sampling was done by continuous method and pregnant women were divided into three groups of delivery ball-warm shower (n = 33), delivery ball (n = 33) and control (n = 33). Exercise with ball at the dilation of 4 cm was similar in the two groups of delivery ball-warm shower and delivery ball, but the first group also used warm shower at the dilatation of 7 cm. The control group only received the routine delivery care. Demographic information form consisting of pregnancy history and information about the mother and infant were completed and the childbirth experience questionnaire (CEQ) were completed by the women two hours after the childbirth. Results There was a statistically significant difference in the mean score of childbirth experience after the intervention between the two groups of delivery ball-warm shower and control (P = 0.001), and also between the delivery ball and control groups (P = 0.001). There was a statistically significant difference in the mean scores of professional support between the two groups of delivery ball-warm shower and control (P = 0.02) and also between the delivery ball and control groups (p = 0.02). There was a statistically significant difference in the mean scores of participation between the two groups of delivery ball-warm shower and control (P = 0.003) and also between the delivery ball and control groups (P = 0.01). There was also a statistically significant difference in the mean scores of sense of security between the two groups of delivery ball-warm shower and control (P = 0.01). Conclusion Delivery ball and warm shower were effective interventions to create a positive childbirth experience. This method was more effective than using delivery ball alone in childbirth experience. To achieve a positive experience of childbirth in mothers, the use of both intervention (delivery ball and warm shower) is recommended.

scholarly journals The effect of distraction techniques on pain and stress during labor: a randomized controlled clinical trial

2019 ◽  
Vol 19 (1) ◽  
Author(s):  
Paria Amiri ◽  
Mojgan Mirghafourvand ◽  
Khalil Esmaeilpour ◽  
Mahin Kamalifard ◽  
Reyhaneh Ivanbagha
Keyword(s):  
Intervention Group ◽  
Active Phase ◽  
Labor Pain ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Fear Of Childbirth ◽  
Control Groups ◽  
Significant Difference ◽  
The Mean ◽  
And Control

Abstract Background Pain control and the stress associated with labor and delivery are among the most important issues of health care system. Use of distraction techniques during childbirth is reported to reduce pain and stress of labor. However, there is a limited publication that looked on the effect of distraction techniques on labor pain and stress. Thus, the aim of this study was to determine the effect of distraction techniques on labor pain and stress (primary outcomes), fear of childbirth, length of delivery stages, first minute Apgar score and oxytocin consumption (secondary outcomes). Methods A randomized controlled clinical trial was conducted on 68 pregnant women. Participants were allocated into two groups (intervention and control groups) by blocked randomization. Participants in the intervention group received distraction techniques in four sessions. Questionnaires of Fear of Childbirth (W-DEQ version A) and PSS once were completed before intervention and again at the 36th week for the W-DEQ and in the active phase for the PSS through interviews. The pain was assessed through VAS during active phase per hour. The length of delivery stages was recorded in the partograph chart. Data were analyzed by independent t-test and ANCOVA. Results The mean of perceived stress during labor in the intervention group was significantly less than that of the control group (AMD: -3.2; 95% CI: − 0.8 to − 6.0; P = 0.01). The mean (SD) of pain intensity during labor was less than in the intervention and control groups compare to the control group (6.2 vs 7.5; P < 0.001). There was no significant difference between the two groups in terms of fear of childbirth score (AMD: 5.3; 95% CI: 13.0 to − 6.0; P = − 2.3). Moreover, there was no statistically significant difference between the two groups in terms of the active phase of labor (P = 0.504), second stage of delivery (P = 0.928), total length of delivery (P = 0.520), Apgar score (P = 1.000) and frequency of oxytocin consumption (P = 0.622). Conclusion According to the results, distraction techniques can reduce the pain and stress of labor, but further studies by using the distraction techniques are needed to reach a decisive conclusion. Trial registration IRCT2017042910324N39; Name of registry: Iranian Registry of Clinical Trials; Registered 11 September 2017. URL of registry: https://fa.irct.ir/user/trial/10814/view. Date of enrolment of the first participant to the trial: September 2017.

scholarly journals Antimicrobial Use in Brazilian Swine Herds: Assessment of Use and Reduction Examples

2021 ◽  
Vol 9 (4) ◽  
pp. 881
Author(s):  
Mauricio Cabral Dutra ◽  
Luisa Zanolli Moreno ◽  
Ricardo Augusto Dias ◽  
Andrea Micke Moreno
Keyword(s):  
Median Number ◽  
Mean Value ◽  
Antimicrobial Use ◽  
Good Practices ◽  
Sanitary Condition ◽  
Significant Difference ◽  
Therapeutic Needs ◽  
The Mean ◽  
Lifetime Exposure ◽  
Swine Herds

Brazil, as a major pig producer, is currently experiencing the widespread use of antimicrobials as a serious issue to be addressed. For measures to be taken in this direction, the extent of the problem must be known. The goal of this study was to evaluate the use of antimicrobials in 25 Brazilian swine herds. Antimicrobial use from birth to slaughter was correlated with biosecurity and productivity. After the first assessment (2016; M0), 13 herds implemented good practices to reduce antimicrobial use. Four years after the implementation of these measures (2020; M1), data about antimicrobial usage from these herds were collected. The results of the first assessment (M0) demonstrated a troublesome scenario: the mean value of antimicrobials used was 358.4 mg/kg of pig produced; the median of the pig’s lifetime exposure to antimicrobials was 73.7%, and the median number of drugs used was seven. A positive correlation between the antimicrobials consumed and the pig’s antimicrobial exposure time was detected. Nevertheless, these data did not correlate with biosecurity score or productivity. A significant difference was detected in M1, where a median 30% reduction in antimicrobials consumed was detected. There was also a 44.3% reduction of the pig’s lifetime exposure to antimicrobials. The median number of drugs used was reduced from seven to five. Antimicrobial use did not always reflect the sanitary condition or the real therapeutic needs, easily leading to overuse.

scholarly journals The effect of local heat therapy on fatigue among patients with chronic obstructive pulmonary disease: A randomized controlled clinical trial

2021 ◽  
Author(s):  
Masume Shahpasand ◽  
Ali Mohammadpour ◽  
Samane Najafi ◽  
Mansooreh Sobhani
Keyword(s):  
Chronic Obstructive Pulmonary Disease ◽  
Pulmonary Disease ◽  
Intervention Group ◽  
Local Heat ◽  
Controlled Clinical Trial ◽  
Chronic Obstructive ◽  
Obstructive Pulmonary Disease ◽  
Significant Difference ◽  
Heat Therapy ◽  
The Mean

Background & Aim: Fatigue is one of the most prevalent symptoms among people with chronic obstructive pulmonary disease (COPD). Heat therapy is considered as one of the proposed methods to relieve the symptoms in these patients. Therefore, the aim of this study was to determine the effect of local heat therapy on fatigue among patients with COPD. Methods & Materials: This randomized controlled clinical trial study was conducted on 46 patients with chronic obstructive pulmonary disease referred to Allameh Bohlool Hospital in Gonabad, Iran in 2019. The participants were selected according to the inclusion criteria and were then randomly assigned to the two groups of intervention and placebo. Local packs were placed on the anterior of the chest twice a day for 23 minutes and for five days among the participants of both groups. The hot pack was 50ºC for the patients in the intervention group, but it was equal to body temperature in the placebo group. The severity of fatigue was once measured before the intervention and then one day after the final intervention in both groups. The demographic information form and Krupp fatigue severity scale were used to collect the data. Descriptive statistics and chi-square, MannWhitney, and Wilcoxon tests were used to analyze the data. Besides, the level of significance was considered at least 0.05. Results: The results indicated that the two groups were homogenous in terms of demographic information and the type of disease (P>0.05). There was no statistically significant difference between the mean score of fatigue before the intervention in the experimental and placebo groups (P=0.9). However, the mean score of fatigue decreased significantly among the intervention group patients compared to those in the placebo group (P<0.001) after the intervention. There was also a significant difference between the two groups in the mean score of fatigue before and after the intervention (P<0.01). Conclusion: According to the results, topical heat therapy is effective in reducing fatigue among patients with COPD, but it is recommended to conduct further studies before the implementation of this approach.

scholarly journals The Effect of Distraction Techniques on Pain and Stress during Labor: A Randomized Controlled Clinical Trial

2019 ◽  
Author(s):  
Paria Amiri ◽  
Mojgan Mirghafourvand ◽  
Khalil Esmaeilpour ◽  
Mahin Kamalifard ◽  
Reyhaneh Ivanbagha
Keyword(s):  
Intervention Group ◽  
Active Phase ◽  
Labor Pain ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Fear Of Childbirth ◽  
Control Groups ◽  
Significant Difference ◽  
The Mean ◽  
And Control

Abstract Background: Pain control and the stress associated with labor and delivery are among the most important issues of health care system. Use of distraction techniques during childbirth is reported to reduce pain and stress of labor. However, there is a limited publication that looked on the effect of distraction techniques on labor pain and stress. Thus, the aim of this study was to determine the effect of distraction techniques on labor pain and stress (primary outcomes), fear of childbirth, length of delivery stages, first minute Apgar score and oxytocin consumption (secondary outcomes). Methods: A randomized controlled clinical trial was conducted on 68 pregnant women. Participants were allocated into two groups (intervention and control groups) by blocked randomization. Participants in the intervention group received distraction techniques in four sessions. Questionnaires of Fear of Childbirth (W-DEQ version A) and PSS once were completed before intervention and again at the 36th week for the W-DEQ and in the active phase for the PSS through interviews. The pain was assessed through VAS during active phase per hour. The length of delivery stages was recorded in the partograph chart. Data were analyzed by independent t-test and ANCOVA . Results: The mean of perceived stress during labor in the intervention group was significantly less than that of the control group (AMD: -3.2; 95% CI: -0.8 to -6.0; P= 0.01). The mean (SD) of pain intensity during labor was less than in the intervention and control groups compare to the control group (6.2 vs 7.5; P<0.001). There was no significant difference between the two groups in terms of fear of childbirth score (AMD: 5.3; 95% CI: 13.0 to -6.0; P= -2.3). Moreover, there was no statistically significant difference between the two groups in terms of the active phase of labor (P= 0.504), second stage of delivery (P= 0.928), total length of delivery (P= 0.520), Apgar score (P= 1.000) and frequency of oxytocin consumption (P= 0.622). Conclusion: According to the results, distraction techniques can reduce the pain and stress of labor, but further studies by using the distraction techniques are needed to reach a decisive conclusion .

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