scholarly journals Antibiotic Stewardship in Patients after Cellular Therapy with Febrile Neutropenia- a Single Center Prospective Unblinded Randomized Trial

Blood ◽  
2021 ◽  
Vol 138 (Supplement 1) ◽  
pp. 747-747
Author(s):  
Ron Ram ◽  
Odelia Amit ◽  
Amos Adler ◽  
Yael Bar-On ◽  
Ofrat Beyar-Katz ◽  
...  
Keyword(s):  
Febrile Neutropenia ◽  
Antibiotic Stewardship ◽  
Cellular Therapy ◽  
Randomized Study ◽  
Intervention Group ◽  
Secondary Outcome ◽  
Control Group ◽  
Single Center ◽  
Car T ◽  
Empiric Antibiotic

Abstract Background: Neutropenic fever is a life-threatening condition which is common in patients undergoing allogeneic/autologous hematopoietic cell transplantation (HCT) or chimeric antigen receptor - T cell (CAR-T) therapy. Empirical treatment includes monotherapy with a beta-lactam containing anti-pseudomonal activity. Nevertheless, stewardship of antibiotic in this vulnerable population is controversial. Methods: This was a single center, prospective, unblinded randomized study, of patients after HCT or CAR-T therapy that were enrolled between January 2020 and March 2021. Allocation was concealed in sequentially numbered sealed opaque envelopes. All patients signed informed consent and the study was approved by the Tel Aviv Medical Center Institutional Review Board. Patients were randomly assigned to receive either standard empiric antibiotic ( piperacillin/tazobactam or ceftazidime) that was continued until recovery of counts (control group), or standard empiric antibiotic that was discontinued after 48-72 hours providing there was no evidence of clinical or microbiology documented infection (intervention group). Rapid identification of bloodstream infections was performed with BioFire filmarray multiplex PCR assay (bioMerieux), and results were used to adjust antibiotic treatment early. The primary outcome was the percentage of days without empiric antibiotic (antibiotic-free-neutropenia days). Secondary outcome included successful response to treatment, defined as the combination of- continuation of clinical improvement on day 5 after initiation of antibiotic, no reoccurrence of bacetermia/fever/clinical infection signs on day 5, and no need for additional therapy on day 4-5 after starting antibiotic. Breakthrough fever, death within 30 days of episode onset, duration of hospitalization, duration of neutropenia, graft vs. host disease (GVHD) and characteristics of cytokine release syndrome (CRS) were also evaluated, as appropriate. Results: 110 patients were randomized to standard therapy (control group, n=51) and antibiotic stewardship strategy (intervention group, n=59), Figure 1. The patients' baseline characteristics were well-balanced between the 2 groups, Table 1. Febrile neutropenia occurred in 91 of the patients, and these patients were eligible for the per-protocol analysis. In the intention-to-treat population, the fraction of antibiotic-free neutropenia days was significantly higher for patients allocated to the stewardship arm, compared to those allocated to the standard arm (median [IQR], 0.8 [0.62-0.86] versus 0.51 [0.17-0.86], respectively, p=.0016). This was also true for the subgroups of patients treated per-protocol (median [IQR], 0.75 [0.61-0.83] versus 0.42 [0.12-0.72], respectively, p<.001) and in the subgroups of patients after allogeneic HCT, autologous HCT and CAR-T therapy (0.75 [0.57-0.86] vs. 0.5 [0.40-0.51], p=.0046; 0.66 [0.62-0.83] vs. 0.59 [0.19-0.81], p=.077; and 0.7 [0.45-0.82] vs 0.06 [0-0.28], p=.025, respectively), Figure 2. There was no difference in the success rate between the 2 groups (84.7% vs. 78%, P =0.45). Thirty-day death rate was similarly low in both groups. Other outcome are depicted in Table 2. Linear regression was used to assess the interaction of patient and treatment variables with the fraction of antibiotic-free days. Assignment to the stewardship arm was significantly associated with a higher fraction of antibiotic-free days (p=.003), whereas CART treatment was associated with a lower fraction of antibiotic-free days (p=.004). Conclusions: This is the first randomized study showing in a homogenous population of patients after cellular therapy, the safety of antibiotic stewardship. Optimization of antibiotic schedule is a widely available and cost-effective strategy to improve treatment outcomes in patients with high risk febrile neutropenia after cellular therapy. Figure 1 Figure 1. Disclosures Ram: Gilead: Honoraria; Novartis: Honoraria. Avivi: Kite, a Gilead Company: Speakers Bureau; Novartis: Speakers Bureau.

scholarly journals Rational and Design of the SIMULATOR Study: A Multicentre Randomized Study to Assess the Impact of SIMULation-bAsed Training on Transoesophageal echocardiOgraphy leaRning for Cardiology Residents

2021 ◽  
Vol 8 ◽  
Author(s):  
Théo Pezel ◽  
Anne Bernard ◽  
Yoan Lavie Badie ◽  
Julien Dreyfus ◽  
Etienne Audureau ◽  
...  
Keyword(s):  
Randomized Study ◽  
Intervention Group ◽  
Medical Residents ◽  
Control Group ◽  
Traditional Teaching ◽  
Single Center ◽  
Simulation Based ◽  
Simulator Study ◽  
And Performance ◽  
The Impact

Introduction: Simulation-based training in transesophageal echocardiography (TEE) seems promising. However, data are limited to non-randomized or single-center studies. To assess the impact of simulation-based vs. traditional teaching on TEE knowledge and performance for medical residents in cardiology.Materials and Methods: Nationwide prospective randomized multicenter study involving 43 centers throughout France allowing for the inclusion of >70% of all French cardiology residents. All cardiology residents naive from TEE will be included. Randomization with stratification by center will allocate residents to either a control group receiving theoretical knowledge by e-learning only, or to an intervention group receiving two simulation-based training sessions on a TEE simulator in addition.Results: All residents will undergo both a theoretical test (0–100 points) and a practical test on a TEE simulator (0–100 points) before and 3 months after the training. Satisfaction will be assessed by a 5-points Likert scale. The primary outcomes will be to compare the scores in the final theoretical and practical tests between the two groups, 3 months after the completion of the training.Conclusion: Data regarding simulation-based learning in TEE are limited to non-randomized or single-center studies. The randomized multicenter SIMULATOR study will assess the impact of simulation-based vs. traditional teaching on TEE knowledge and performance for medical residents in cardiology, and whether such an educational program should be proposed in first line for TEE teaching.

scholarly journals Effectiveness and cost-effectiveness of an optimized process of providing assistive technology for impaired upper extremity function: Protocol of a prospective, quasi-experimental non-randomized study (OMARM)

2021 ◽  
pp. 1-14
Author(s):  
Uta Roentgen ◽  
Loek van der Heide ◽  
Ingrid E.H. Kremer ◽  
Huub Creemers ◽  
Merel A. Brehm ◽  
...  
Keyword(s):  
Cost Effectiveness ◽  
Assistive Technology ◽  
Upper Extremity ◽  
Randomized Study ◽  
Intervention Group ◽  
Control Group ◽  
Full Potential ◽  
Extremity Function ◽  
Quasi Experimental ◽  
Upper Extremity Function

BACKGROUND: Impaired upper extremity function due to muscle paresis or paralysis has a major impact on independent living and quality of life (QoL). Assistive technology (AT) for upper extremity function (i.e. dynamic arm supports and robotic arms) can increase a client’s independence. Previous studies revealed that clients often use AT not to their full potential, due to suboptimal provision of these devices in usual care. OBJECTIVE: To optimize the process of providing AT for impaired upper extremity function and to evaluate its (cost-) effectiveness compared with care as usual. METHODS: Development of a protocol to guide the AT provision process in an optimized way according to generic Dutch guidelines; a quasi-experimental study with non-randomized, consecutive inclusion of a control group (n= 48) receiving care as usual and of an intervention group (optimized provision process) (n= 48); and a cost-effectiveness and cost-utility analysis from societal perspective will be performed. The primary outcome is clients’ satisfaction with the AT and related services, measured with the Quebec User Evaluation of Satisfaction with AT (Dutch version; D-QUEST). Secondary outcomes comprise complaints of the upper extremity, restrictions in activities, QoL, medical consumption and societal cost. Measurements are taken at baseline and at 3, 6 and 9 months follow-up.

A Randomized Study to Assess the Impact of Pharmacist Counseling of Employer-Based Health Plan Beneficiaries With Diabetes

2011 ◽  
Vol 25 (2) ◽  
pp. 169-179 ◽  
Author(s):  
Dale F. Kraemer ◽  
Wayne A. Kradjan ◽  
Theresa M. Bianco ◽  
Judi A. Low
Keyword(s):  
Diabetes Management ◽  
Statistical Significance ◽  
Glycosylated Hemoglobin ◽  
Randomized Study ◽  
Intervention Group ◽  
Control Group ◽  
Counseling Intervention ◽  
Care Plans ◽  
Pharmacist Counseling ◽  
The Impact

Objective: To assess the impact of pharmacist counseling on empowering people with diabetes to better self-care. Introduction: Community-based pharmacists can play a key role in educating and empowering people in such programs. Methods: A randomized trial compared the effects of pharmacist counseling (intervention group) with printed materials (control group) in diabetic beneficiaries of several employer-based health care plans. All participants also received waiver of out-of-pocket expenses for diabetic-related medications and supplies. Clinical, humanistic, and claim outcomes were evaluated at baseline and at 1 year follow-up. Results: Sixty-seven beneficiaries participated in this study. The 0.50% decrease from baseline in glycosylated hemoglobin (A1c) was statistically significant ( P = .0008) in the intervention group and the difference between the groups approached statistical significance ( P = .076). Beneficiaries in both groups had greater claim costs for diabetic-related medications and supplies during the study year. Both groups also improved in ability to manage their diabetes with the counseling group showing a significantly better understanding of diabetes ( P = .0024). Conclusion: There was a trend toward improvement in A1c in patients counseled by pharmacist with an increased utilization of diabetes-related medications and supplies. Counseling also improved diabetes knowledge and empowered patients to better diabetes management.

scholarly journals Impact of ascorbic acid in reducing the incidence of vancomycin associated nephrotoxicity in critically ill patients: A preliminary randomized controlled trial

F1000Research ◽  
2021 ◽  
Vol 10 ◽  
pp. 929
Author(s):  
Nouran Hesham El-Sherazy ◽  
Naglaa Samir Bazan ◽  
Sara Mahmoud Shaheen ◽  
Nagwa A. Sabri
Keyword(s):  
Ascorbic Acid ◽  
Critically Ill ◽  
Critically Ill Patients ◽  
Statistical Significance ◽  
Intervention Group ◽  
Secondary Outcome ◽  
Control Group ◽  
Control Groups ◽  
The Absolute ◽  
And Control

Background Antioxidants show nephroprotective effect against vancomycin associated nephrotoxicity (VAN) in animals. This study aimed to assess the ascorbic acid nephro-protective role against VAN clinically. Methods Forty-one critically ill patients were randomly assigned to one of two groups: intervention group (vancomycin IV plus ascorbic acid, n=21) or control group (vancomycin IV only, n=20). Primary outcomes were the incidence of VAN and the absolute change in creatinine parameters, while mortality rate was the secondary outcome. Nephrotoxicity was defined as an increase in serum creatinine (S.cr) by at least 0.5 mg/dL or 50% of baseline for at least two successive measurements. This study is registered at Clinicaltrials.gov (NCT03921099), April 2019. Results Mean absolute S.cr increase was significant when compared between both groups, P-value = 0.036, where S.cr increased by 0.05(0.12) and 0.34(0.55) mg/dL in the intervention and control groups, respectively. Mean absolute Cr.cl decline was significant when compared between both groups, P-value = 0.04, where Cr.cl was decreased by 5.9(17.8) and 22.3(30.4) ml/min in the intervention and control groups, respectively. Incidence of VAN was 1/21(4.7%) versus 5/20(25%) in the intervention and control groups, respectively (RR: 0.19; CI: 0.024–1.49; P-value = 0.093). Mortality was higher in the control group; however, it was not statistically significant, P-value = 0.141. Conclusion Co-administration of ascorbic acid with vancomycin preserved renal function and reduced the absolute risk of VAN by 20.3%, however, the reduction in VAN incidence didn’t reach statistical significance level. Further large multicenter prospective trials are recommended.

scholarly journals Scaled-Up Nutrition Education on Pulse-Cereal Complementary Food Practice in Ethiopia: A Cluster-Randomized Trial

2020 ◽  
Author(s):  
Getenesh Berhanu Teshome ◽  
Susan J. Whiting ◽  
Timothy J. Green ◽  
Demelash Mulualem ◽  
Carol J. Henry
Keyword(s):  
Nutritional Status ◽  
Nutrition Education ◽  
Weight Status ◽  
Dietary Diversity ◽  
Randomized Study ◽  
Intervention Group ◽  
Complementary Food ◽  
Southern Ethiopia ◽  
Control Group ◽  
Cluster Randomized

Abstract Background Improving children's weight status through nutrition education (NE) for mothers about using pulses in complementary feeding has been demonstrated in pilot studies, but no effect on stunting was reported. The aim of the study was to evaluate the effectiveness of a 9-month pulse-nutrition education program on mothers' knowledge, attitude, and practices (KAP) towards pulses, as well as its impact on children's dietary diversity, and nutritional status. The NE was delivered by Health Extension Workers (HEWs). Methods A cluster randomized study was employed for the community-based interventional study. Twelve randomly selected villages in Sidama Zone, Southern Ethiopia were included in the study. A total of 772 mother-child pairs involved in the study; where 386 mother-child pairs in the intervention group received additional messages about pulse-cereal complementary food, and 386 pairs (the control) received only routine health education for 9 months. A survey on mothers’ KAP and anthropometric measurements of the children were taken at baseline, midline, and endline. Results At baseline and endline, maternal KAP and the dietary diversity score of the children (mean age at endline 18.8 ± 2.9 mo) were assessed. Results : Intervention mothers’ KAP improved ( p <0.001) at midline and endline compared to that of the control group, as did frequency of pulse consumption and DDS among children. At 9 months, the prevalence of stunting, wasting, and underweight was significantly reduced in the intervention group compared to the control group ( p =0.001). Conclusions NE delivered by HEWs improved KAP of mothers regarding pulse consumption and dietary diversity of children led to improved nutritional status of the children. Training HEWs on the use of pulses for CF may be an effective way to improve the health of children in Ethiopian communities.

Evaluating the effects of a mindfulness mobile application on student pharmacists’ stress, burnout, and mindfulness

2021 ◽  
Author(s):  
Angela Chu ◽  
Tyler M Rose ◽  
Danielle A Gundrum ◽  
Tressa E McMorris ◽  
Eytan A Klausner ◽  
...  
Keyword(s):  
Mobile Application ◽  
Controlled Trial ◽  
Intervention Group ◽  
Secondary Outcome ◽  
Control Group ◽  
Intervention Period ◽  
Entire Study ◽  
Positive Effects ◽  
Waitlist Control Group

Abstract Disclaimer In an effort to expedite the publication of articles, AJHP is posting manuscripts online as soon as possible after acceptance. Accepted manuscripts have been peer-reviewed and copyedited, but are posted online before technical formatting and author proofing. These manuscripts are not the final version of record and will be replaced with the final article (formatted per AJHP style and proofed by the authors) at a later time. Purpose Pharmacists report high levels of burnout. Mindfulness approaches have been demonstrated to have positive results in the general population and in other healthcare professions. However, limited studies have been performed evaluating mindfulness approaches in student pharmacists. The aim of this study was to evaluate the effectiveness of daily use of a mindfulness mobile application in improving student pharmacists’ perceived stress, burnout, and mindfulness. Methods This study was a randomized, longitudinal, waitlist-controlled trial. The intervention group was asked to meditate using the mindfulness application Headspace daily for at least 6 weeks. The waitlist control group was asked to abstain from using the application for the entire study. Stress, burnout, and mindfulness were assessed using validated survey instruments at baseline, 6 weeks, and 10 weeks. A secondary outcome was to assess the persistence of application use after the intervention period. Results Fifty-six participants completed the study. The intervention group reported significantly lower scores on stress and burnout at 6 weeks compared to the control group. The intervention group also reported significantly higher scores on mindfulness. The differences in stress, burnout, and mindfulness persisted at follow-up. The mean percentage of students in the intervention group who used the application each day was 90% over the intervention period and 62% over the follow-up period. Conclusion A mindfulness mobile application significantly improved student pharmacists’ stress, burnout, and mindfulness with daily use. Most participants continued to use the application for 4 weeks after the end of the intervention. Positive effects on stress and mindfulness persisted even with decreased use.

Abstract WP221: Very Brief Intervention Improves Stroke Response in a Randomized Trial: Stroke Ready Very Brief Intervention

Stroke ◽  
2020 ◽  
Vol 51 (Suppl_1) ◽  
Author(s):  
Lesli E Skolarus ◽  
Maria Cielito Robles ◽  
Springer Mellanie ◽  
Chun Chieh Lin ◽  
Casey Corches ◽  
...  
Keyword(s):  
Brief Intervention ◽  
Action Plan ◽  
Controlled Trial ◽  
Intervention Group ◽  
Secondary Outcome ◽  
Average Score ◽  
Control Group ◽  
Symptom Recognition ◽  
Stroke Symptom ◽  
One To One

Introduction: Stroke pre-hospital delay has not improved over time. Hypothesis: Stroke Ready, a very brief (5 minute), theory based, peer-led, stroke preparedness intervention, will increase stroke response compared with a control intervention. Methods: We performed a randomized, single-blind controlled trial among adults in Flint, MI. The stroke preparedness intervention group received a Stroke Ready pamphlet and action plan, while the control group received stroke prevention materials - both delivered during a one-to-one interaction with a trained peer educator. Research staff, blinded to group intervention assignment, assessed baseline and immediate post-intervention outcomes. Primary outcome was change in stroke response (behavioral intent to call 911) using a community-modified stroke action test (range 0-12). Secondary outcome was change in stroke symptom recognition (range 0-8). We conducted descriptive analyses and used a linear regression model to evaluate the effect of the intervention on stroke response after adjustment for pre-intervention intent, age, education, race, marital status, history of stroke, stroke in someone they know and psychological constructs. Results: We enrolled 129 participants (74 intervention; 55 control). Mean age was 60 years (SD 14); 61% were women, 89% were African American and 19% were not high school graduates. Intervention participants had greater improvement in stroke response than control participants (figure 1), which remained after full adjustment (improvement in average score for stroke response was 1.7 higher in intervention participants than control participants, 95% CI 0.9-2.5, p<0.0001). There was no difference in stroke symptom recognition (figure 1). Conclusion: The Stroke Ready very brief intervention increased stroke response. This new approach using a very brief, one-to-one interaction with trained peer educators is a promising, scalable, intervention to increase stroke response.

scholarly journals Effectiveness of a primary care-based group educational intervention in the management of patients with migraine: a randomized controlled trial

2019 ◽  
Vol 20 ◽  
Author(s):  
Iñaki Aguirrezabal ◽  
Maria Soledad Pérez de San Román ◽  
Raquel Cobos-Campos ◽  
Estibalitz Orruño ◽  
Arturo Goicoechea ◽  
...  
Keyword(s):  
Primary Care ◽  
Educational Intervention ◽  
Controlled Trial ◽  
Basque Country ◽  
Intervention Group ◽  
Cost Effective ◽  
Response To Treatment ◽  
Secondary Outcome ◽  
Control Group ◽  
Randomised Controlled

Abstract Aim: The aim of this study was to assess the effectiveness of a primary care-based group educational intervention about concepts of pain neuroscience for the management of migraine compared to the routine medical care delivered to patients with this condition. Background: The way pain is understood has been radically changed in recent decades, thanks to developments in the field of neuroscience. Thus, migraine may develop as a result of an exaggerated perception of threat that activates the pain neuromatrix, which might be modifiable, from a learning perspective, by adjusting the beliefs and behaviours that favour the onset of an attack. Methods: A randomised controlled trial was carried out in five primary care health centres of Vitoria-Gasteiz (Basque Country, Spain). The follow-up period was 12 months. The main outcome measure was the reduction in days lost due to migraine-related disability according to the Migraine Disability Assessment Test (MIDAS) score. Secondary outcome measures included the intensity and frequency of the pain and the number of analgesic drugs taken in the previous three months. A positive response to treatment was considered when the MIDAS score decreased by at least 50% from baseline. Findings: Days lost due to migraine-related disability decreased by at least 50% in 68.9% (n = 37) of patients in the intervention group and 34.6% of patients in the control group (n = 18) (P < 0.001). The intensity of the headache [odds ratio (OR) 9.116; P = 0.005] and the medication intake (OR 13.267; P < 0.001) were also significantly reduced with the intervention. Conclusions: The provision of suitable information through a group educational intervention delivered in primary care appears to be effective in preventing migraine attacks. Moreover, the intervention could offer a new cost-effective management alternative that seems to reduce the need for pharmacological treatment in patients with migraine.

scholarly journals Safety and effectiveness of a Tai Chi-based cardiac rehabilitation programme for chronic coronary syndrom patients: study protocol for a randomised controlled trial

BMJ Open ◽  
2020 ◽  
Vol 10 (7) ◽  
pp. e036061
Author(s):  
Jing Ma ◽  
Jian wei Zhang ◽  
Hua Li ◽  
Lian shan Zhao ◽  
Ai ying Guo ◽  
...  
Keyword(s):  
Cardiac Rehabilitation ◽  
Outcome Measures ◽  
Tai Chi ◽  
Short Form ◽  
Intervention Group ◽  
Secondary Outcome ◽  
Control Group ◽  
Cardiac Rehabilitation Programme ◽  
Tai Chi Exercise ◽  
Randomised Controlled

IntroductionPreliminary evidence from clinical observations suggests that Tai Chi exercise may offer potential benefits for patients with chronic coronary syndrom (CCS). However, the advantages for CCS patients to practice Tai Chi exercise as rehabilitation have not been rigorously tested and there is a lack of consensus on its benefits. This study aims to develop an innovative Tai Chi Cardiac Rehabilitation Program (TCCRP) for CCS patients and to assess the efficacy, safety and acceptability of the programme.Methods and analysisWe propose to conduct a multicentre randomised controlled clinical trial comprising of 150 participants with CCS. The patients will be randomly assigned in a 1:1 ratio into two groups. The intervention group will participate in a supervised TCCRP held three times a week for 3 months. The control group will receive supervised conventional exercise rehabilitation held three times a week for 3 months. The primary and secondary outcomes will be assessed at baseline, 1 month, 3 months after intervention and after an additional 3-month follow-up period. Primary outcome measures will include a score of 36-Item Short Form Survey and Chinese Perceived Stress Scale. The secondary outcome measures will include body composition, cardiopulmonary exercise test, respiratory muscle function, locomotor skills, echocardiogram, New York Heart Association classification, heart rate recovery time and laboratory examination. Other measures also include Seattle Angina Scale, Pittsburgh Sleep Quality Index, Patient Health Questionnaire-9, Generalized Anxiety Disorder-7 and Berg Balance Scale. All adverse events will be recorded and analysed.Ethics and disseminationThis study conforms to the principles of the Declaration of Helsinki and relevant ethical guidelines. Ethical approval has been obtained from the Ethics Committee of Chinese People’s Libration Army General Hospital (approval number: S2019-060-02). Findings from this study will be published and presented at conferences for widespread dissemination of the results.Trial registration numberNCT03936504.

An Interactive Web-Based Intervention to Achieve Healthy Weight in Young Children

2017 ◽  
Vol 57 (5) ◽  
pp. 547-557 ◽  
Author(s):  
Ellen R. Wald ◽  
Linda J. Ewing ◽  
Stacey C. L. Moyer ◽  
Jens C. Eickhoff
Keyword(s):  
Healthy Lifestyle ◽  
Controlled Trial ◽  
Intervention Group ◽  
Lifestyle Changes ◽  
Secondary Outcome ◽  
Control Group ◽  
Healthy Weight ◽  
Healthy Behavior ◽  
Reduced Body ◽  
Z Scores

This prospective, randomized, controlled trial for parents of overweight and obese 3- to 7-year-olds was performed to assess the feasibility of a program promoting healthy eating and lifestyle by targeting parents as agents of change. The intervention was composed of 6-in-person group sessions and a customized website over 12 months. The control group received customary care. The primary outcome was feasibility of the intervention to promote healthy behavior change measured by attendance. The secondary outcome was effectiveness assessed by attaining reduced body mass index (BMI) z scores, healthy behavior changes and increased parent self-efficacy. Seventy-three child-parent dyads were enrolled; 14 parents never attended any sessions. Participation in follow-up assessments did not meet the hypothesized level. Ultimate BMI z scores did not differ between control and intervention groups. Parenting skills did not improve in the intervention group. This intervention to achieve healthy lifestyle changes in children via their parents as “change agents” was unsuccessful.

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