scholarly journals 841. Implications of C. difficile Treatment on Environmental Contamination: A Randomized Controlled Trial with Microbiologic, Environmental, and Molecular Outcomes

2019 ◽  
Vol 6 (Supplement_2) ◽  
pp. S11-S12
Author(s):  
Nicholas A Turner ◽  
Maria Gergen ◽  
William Rutala ◽  
Daniel J Sexton ◽  
Vance G Fowler, Jr. ◽  
...  

Abstract Background Clostridioides difficile is a leading cause of healthcare-associated infection. Despite multimodal prevention efforts, in-hospital transmission continues to occur. In this study, we tested whether the choice of treatment can reduce C. difficile shedding and contamination of the inpatient environment. Methods We conducted a prospective, unblinded, randomized controlled trial of adult inpatients with C. difficile at Duke University Hospital. Thirty subjects were randomized 1:1:1 to receive metronidazole, vancomycin, or fidaxomicin. Stool specimens and environmental samples from five high-touch surfaces were serially collected throughout each subject’s hospital stay. Each specimen was assessed by quantitative culture and PCR ribotyping. Primary outcomes included the change over time in C. difficile stool burden and environmental contamination relative to treatment choice. As a secondary outcome, we examined the correlation between infecting strains and contaminating strains present in the care environment. Results Relative to metronidazole (Figure 1), C. difficile stool shedding decreased more rapidly for patients receiving vancomycin (P = 0.05) and most rapidly with fidaxomicin (P = 0.002). Treatment choice had no significant effect on total C. difficile colony counts across sites sampled over time (Figure 2). However, both vancomycin (P = 0.001) and fidaxomicin (P = 0.01) were associated with lower proportions of positive environmental cultures than metronidazole (Figure 3). Ribotyping of subjects’ stool isolates matched surrounding environmental isolates >90% of the time (Figure 4). Conclusion Fidaxomicin and vancomycin reduced C. difficile stool burden more rapidly than metronidazole. Environmental results were mixed: fidaxomicin and vancomycin were associated with fewer positive surface cultures, but no difference in total colony counts. High concordance between stool and environmental ribotypes confirms that most room contamination originated from study subjects, without a significant contribution from any additional sources. Treatment choice may have a role in reducing C. difficile contamination of the hospital environment. Further study is needed to assess for effect on disease incidence. Disclosures All Authors: No reported Disclosures.

2020 ◽  
Vol 29 (1S) ◽  
pp. 412-424
Author(s):  
Elissa L. Conlon ◽  
Emily J. Braun ◽  
Edna M. Babbitt ◽  
Leora R. Cherney

Purpose This study reports on the treatment fidelity procedures implemented during a 5-year randomized controlled trial comparing intensive and distributed comprehensive aphasia therapy. Specifically, the results of 1 treatment, verb network strengthening treatment (VNeST), are examined. Method Eight participants were recruited for each of 7 consecutive cohorts for a total of 56 participants. Participants completed 60 hr of aphasia therapy, including 15 hr of VNeST. Two experienced speech-language pathologists delivered the treatment. To promote treatment fidelity, the study team developed a detailed manual of procedures and fidelity checklists, completed role plays to standardize treatment administration, and video-recorded all treatment sessions for review. To assess protocol adherence during treatment delivery, trained research assistants not involved in the treatment reviewed video recordings of a subset of randomly selected VNeST treatment sessions and completed the fidelity checklists. This process was completed for 32 participants representing 2 early cohorts and 2 later cohorts, which allowed for measurement of protocol adherence over time. Percent accuracy of protocol adherence was calculated across clinicians, cohorts, and study condition (intensive vs. distributed therapy). Results The fidelity procedures were sufficient to promote and verify a high level of adherence to the treatment protocol across clinicians, cohorts, and study condition. Conclusion Treatment fidelity strategies and monitoring are feasible when incorporated into the study design. Treatment fidelity monitoring should be completed at regular intervals during the course of a study to ensure that high levels of protocol adherence are maintained over time and across conditions.


Author(s):  
Kari Bø ◽  
Lene Anette H. Haakstad ◽  
Gøran Paulsen ◽  
Anne Mette Rustaden

Abstract Introduction and hypothesis Urinary incontinence (UI) is common in women who exercise. We aimed to investigate new onset UI in formerly inactive, overweight or obese women (BMI > 25) participating in three different strength training modalities compared with a non-exercising control group. Methods This was a secondary analysis of an assessor blinded randomized controlled trial investigating the effect of 12 weeks of three strength training concepts for women on muscle strength and body composition. None of the programs included pelvic floor muscle training. International Consensus on Incontinence Questionnaire Urinary Incontinence Short Form (ICIQ-UI-SF) was used to investigate primary outcome; new onset UI, and secondary outcome; ICIQ-UI-SF sum score. Suissa and Shuster’s exact unconditional test was used to analyze difference in new onset UI. Difference in ICIQ-UI-SF sum score is presented as mean with 95% CI. Results At baseline 40 out of 128 (31.2%) participants reported UI. Three out of 27, 2 out of 17, 2 out of 23, and 0 out of 21 women in the three training and control groups respectively had new onset UI. There were no statistically significant differences in new onset UI across the groups or when collapsing new onset UI in the intervention groups compared with the controls (7 out of 67 vs 0 out of 21), p = 0.124. After the intervention the control group reported worse ICIQ-UI-SF sum score than any of the training groups; mean difference − 6.6 (95% CI: −11.9, −1.27), p = 0.012, but there was no difference in change from baseline to 12 weeks between the groups p = 0.145). Conclusions There was no statistically significant change in UI after strength training.


2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 7.1-8
Author(s):  
A. Luquini ◽  
Y. Zheng ◽  
H. Xie ◽  
C. Backman ◽  
P. Rogers ◽  
...  

Background:Arthritis often leads to presenteeism (decreased at-work productivity), missed days from work and permanent work disability, leading to reduced quality of life and high costs to individuals and society. Yet, health services addressing the employment needs of people with arthritis are lacking.Objectives:We evaluated the effectiveness of the Making-it-WorkTM(MiW) program, an online self-management program developed to help people with inflammatory arthritis (IA) deal with employment issues.Methods:A multi-center RCT evaluated the effectiveness of MiW at improving presenteeism and preventing work cessation (WC) over two years. Participants were recruited from rheumatologist practices, consumer organizations and arthritis programs, in three Canadian provinces. Eligibility criteria: diagnosis of IA, employed, age 18-59, and concerned about ability to work. Participants were randomized 1:1 to MiW or usual care plus printed material on workplace tips. MiW consists of five online self-learning modules and group meetings, and individual vocational counselling and ergonomic consultations. Questionnaires were administered every 6 months. Outcomes were presenteeism [Rheumatoid Arthritis Work Instability Scale (RA-WIS)], time to WC ≥ 6 months, and time to WC ≥ 2 months (secondary outcome). Baseline characteristics (age, gender, ethnicity, occupation, education, disease duration and self-employment) were collected. Intention-to-treat (ITT) longitudinal analysis of RA-WIS using linear mixed effect regression models with 2-year comparison as primary endpoint and survival analysis for time to WC using Kaplan-Meier and Cox Proportional Hazard models were performed. Robustness analyses were conducted by using various missing values imputation methods like last observation carried forward, imputation using worse possible outcomes and model-based multiple imputations; using square root transformation of RA-WIS outcome; and adjusting for baseline covariates. SAS version 9.4 was used.Results:A total of 564 participants were recruited, with 478 (84.75%) completing 2-year follow-up. Baseline characteristics were similar between groups. Mean RA-WIS scores were significantly lower in the intervention group from 6 months onwards, with the greatest difference observed at 2 years (-1.78, 95%CI: -2.7, -0.9, p < .0001), yielding a standardized effect size of 32%. Satisfactory robustness was observed. Work cessation occurred less often in intervention than control groups, but only reached statistical significance for WC ≥ 2 months (WC ≥ 6 months: 31 versus 44 events, aHR 0.70, 95%CI: 0.44, 1.11, p = 0.13; WC ≥ 2 months: 39 versus 61 events, aHR: 0.65, 95%CI: 0.43, 0.98, p = 0.04).Conclusion:Results of the RCT reveal the program was effective at improving presenteeism and preventing short-term WC. Effectiveness at preventing long-term work disability will be assessed at 5 years. This program fills one of the most important and costly unmet needs for people with inflammatory arthritis.References:[1]Carruthers EC, Rogers P, Backman CL, et al. “Employment and arthritis: making it work” a randomized controlled trial evaluating an online program to help people with inflammatory arthritis maintain employment (study protocol).BMC Med Inform Decis Mak. 2014;14:59. Published 2014 Jul 21. doi:10.1186/1472-6947-14-59Disclosure of Interests:Andre Luquini: None declared, Yufei Zheng: None declared, Hui Xie: None declared, Catherine Backman: None declared, Pamela Rogers: None declared, Alex Kwok: None declared, Astrid Knight: None declared, Monique Gignac: None declared, Dianne Mosher: None declared, Linda Li: None declared, John Esdaile: None declared, Carter Thorne Consultant of: Abbvie, Centocor, Janssen, Lilly, Medexus/Medac, Pfizer, Speakers bureau: Medexus/Medac, Diane Lacaille: None declared


2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Jacomijn Hofstra ◽  
Jorien van der Velde ◽  
Petra Jannette Havinga ◽  
Lies Korevaar

Abstract Background The onset of mental health problems generally occurs between the ages of 16 and 23 – the years in which young people follow post-secondary education, which is a major channel in our society to prepare for a career and enhance life goals. Several studies have shown that students with mental health problems have a higher chance of early school leaving. Supported Education services have been developed to support students with mental health problems to remain at school. The current project aims to study the effect of an individually tailored Supported Education intervention on remaining at school, study success, and satisfaction of students with mental health problems studying at an institute for intermediate vocational education and a university of applied sciences in the Netherlands. Methods/design The design combines quantitative research (Randomized Controlled Trial; RCT) with qualitative research (monitoring, interviews, focus groups). One hundred students with mental health problems recruited from the two educational institutes will be randomly allocated to either the intervention or control condition. The students in the intervention condition receive the Supported Education intervention given by a Supported Education specialist, the students in the active control condition receive support as usual plus advice from a trained staff member on potential supportive resources regarding studying with mental health problems. The primary outcome ‘remaining at school’, and the secondary outcome ‘study success’ will be determined using data from the school’s administration. The secondary outcome ‘student satisfaction’ and other variables that will be studied in a more exploratory way, such as self-efficacy and study skills, will be determined through online questionnaires at baseline, at 6 and at 12 months follow-up. Focus groups and interviews with the students and Supported Education specialists will be carried out to complement the trial. Discussion This RCT is the first to assess the effect of Supported Education on remaining at school, next to study success and student satisfaction among students with mental health problems. The use of a mixed-methods design will result in a thorough evaluation of the effect of the intervention. Issues regarding the influx and possible attrition of students in the follow-up are discussed. Trial registration The study was registered with Trialregister.nl, no. NL8349, date registered: February 4th 2020. Register name: Community participation through education. Effectiveness of Supported Education for youth with mental health problems, a mixed methods study – Study protocol for a Randomized Controlled Trial. Protocol Version: 3, date: May 28th, 2021.


2021 ◽  
Vol 10 (10) ◽  
pp. 2182
Author(s):  
Jihyun Kim ◽  
Hoyoung Lee ◽  
Tae-Young Choi ◽  
Joong Il Kim ◽  
Byoung-Kab Kang ◽  
...  

Acupuncture is believed to improve ovarian reserve and reproductive outcomes in women undergoing in vitro fertilization (IVF). This study was conducted to evaluate the effect of network-optimized acupuncture followed by IVF on the oocyte yield in women showing a poor ovarian response. This study was an exploratory randomized controlled trial conducted from June 2017 to January 2020 at the Pusan National University Hospital. Women diagnosed with poor ovarian response were enrolled and randomly divided into two groups: IVF alone and Ac + IVF groups (16 acupuncture sessions before IVF treatment). Eight acupoints with high degree centrality and betweenness centrality were selected using network analysis. Among the participants, compared with the IVF treatment alone, the acupuncture + IVF treatment significantly increased the number of retrieved mature oocytes in women aged more than 37 years and in those undergoing more than one controlled ovarian hyperstimulation cycle. The negative correlation between the number of retrieved mature oocytes and consecutive controlled ovarian hyperstimulation cycles was not observed in the Ac + IVF group irrespective of the maternal age. These findings suggest that physicians can consider acupuncture for the treatment of women with poor ovarian response and aged > 37 years or undergoing multiple IVF cycles.


PEDIATRICS ◽  
2000 ◽  
Vol 105 (Supplement_3) ◽  
pp. 935-940 ◽  
Author(s):  
Sally Longstaffe ◽  
Michael E. K. Moffatt ◽  
Jeanne C. Whalen

Background. Previous studies have suggested changes in self-concept with successful treatment of primary nocturnal enuresis (PNE), but behavioral changes have not been reported as a consistent associated finding. Objective. To determine if self-concept and behavior change after 6 months of treatment of monosymptomatic PNE by conditioning alarm or desmopressin acetate (DDAVP). Design. Randomized, controlled trial in an inner-city hospital clinic. Subjects were 182 children referred or recruited through media publicity, randomly assigned both to 1 of 8 pediatricians and 1 of 3 treatment groups (alarm, DDAVP, or placebo). Included were children &gt;7 years old with PNE, no daytime symptoms, bladder capacity &gt;50% expected, and wetting &gt;3 times a week. Excluded were children with central nervous system disorders or developmental delays, and those currently on DDAVP or alarm. Subjects completed thePiers-Harris Children's Self-Concept Scale and Harter's Perceived Competence Scale for Children (PCSC) at initial visit and after 6 months of treatment. Parents completed the Achenbach Child Behavior Checklist (CBCL) at the same times. Results. After 6 months of treatment the Piers-Harris total score showed a highly significant treatment by period interaction effect for DDAVP, a significant effect for alarm, and no effect for placebo. For children who achieved 75% dryness the CBCL showed a treatment by improvement interaction effect that was highly significant for DDAVP and placebo with no effect for alarm. For the PCSC there were no treatment or outcome interaction effects. After 6 months of treatment there were significant changes over time unrelated to outcome or treatment in the Piers-Harris Subscales and in the CBCL Internalizing and Externalizing Scores, and the Social Thought and Attention Problems Subscales. The PCSC was more stable with no changes in total score, and positive changes over time in only 2 Subscales, Scholastic and Social. Conclusion. Children's self-concept improved with the type of treatment and amount of success. Parents' perceptions of behavior improve with type of treatment and amount of success. Children rate their self-concept and some physical attributes better after treatment with any of DDAVP, alarm, or placebo regardless of outcome. Frequent follow-up with emotional support and encouragement appear to be important components of an efficacious intervention for children with nocturnal enuresis.


2014 ◽  
Vol 7 (1) ◽  
pp. 40-45 ◽  
Author(s):  
Surajit Awsakulsutthi ◽  
Kwanjit Punpho ◽  
Jinpitcha Mamom ◽  
Pairat Baikrut ◽  
Patcharee Yingchoorod

2020 ◽  
Author(s):  
Shanshan Li ◽  
Qing Zhang ◽  
Xuan Yin ◽  
Hongyu Yue ◽  
Wei Zhang ◽  
...  

Abstract Background: Postoperative pain is a common disorder that interferes with the quality of sleep after nasal endoscopic surgery and delays postoperative recovery. Acupuncture is an effective tool for pain management. However, electroacupuncture specifically for the relief of postoperative pain after nasal endoscopic surgery has not yet been studied through a randomized controlled trial. Method/Design: A pilotrandomized, sham-controlled, patient- and- assessor-blind trial is designed to evaluate the efficacy and safety of electroacupuncturein managing postoperative pain following nasal endoscopic surgery of sinusitis with nasal polyps. There will be 30participants randomly allocated to an electroacupuncture or non-invasive sham control in a 1:1 ratio. Treatment will be done within 2 hours before operation, immediately after the operation upon arrival to the recovery ward, and once daily for 3 days. The primary outcome of the Pain Numerical Rating Scale (NRS) will be analyzed using the area-under-the-curve (AUC) method. The secondary outcome measures include Heart Rate (HR) and Blood Pressure (BP) after operation, the sleep quality during the hospital stay (Actigragh),Quality of Recovery-15 (QoR-15), and the MOS item short form health survey (SF-36). ITT analysis will be used in this RCT. Discussion: This pilot randomized controlled trial will explore the feasibility of further clinical application for the management of postoperative pain using electroacupuncture treatment, and it will inform the design of a further full-scale trial. Trial Registration: Chinese Clinical Trial Registry, ChiCTR1900024183, Date: 2019-06-29. URL: http://www.chictr.org.cn/showproj.aspx?proj=40573 Keywords: Electroacupuncture; postoperative pain;nasal endoscopic surgery; RCT; randomized controlled trial; clinical trial


2017 ◽  
Vol 4 (7) ◽  
pp. 2291
Author(s):  
Rajasekaran C. ◽  
Vijaykumar K. ◽  
Arulkumaran M. ◽  
Meera S. S.

Background: Incisional hernia forms the most common delayed morbidity following midline laparotomy surgeries- causing mental trauma to the patient impairing their quality of life and scars the name and fame of the surgeon. So, the need for possible attributes on surgeon’s aspect to prevent the incisional hernia is the need of the hour. We planned a randomized controlled trial to compare two different abdominal closure techniques to reduce the incidence of Incisional hernia following midline laparotomy incisions. We advocated Hughes abdominal repair which includes a series of two horizontal and two vertical mattresses within single suture whereby the tension load of suture is distributed both along and across the suture line.Methods: 1:1 Randomized controlled trial in which the patient is blinded and obviously operating surgeon is non-blinded. Evaluating examiner and radiologist are blinded.100 patients who underwent emergency and elective midline laparotomies were enrolled in the study and intra-operatively randomized into two groups in 1:1 pattern. Ethical clearance obtained from the Institutional ethical committee. The primary outcome measure is the incidence of burst abdomen at the end of 15 days by the evaluating surgeon (non-operated surgeon who is blinded). The secondary outcome is the incidence of incisional hernia at the end of one year-evaluated by detailed clinical examination with radiological proof using CT abdomen.Results: The incidence of incisional hernia is significantly low in Hughes abdominal repair than conventional abdominal closure.Conclusions: Hughes abdominal wall closure is superior to conventional closure in both emergency and elective laparotomy cases, in prevention of wound dehiscence and Incisional hernias later. Present study encourages us that Hughes abdominal wall repair is comparable to mesh repairs. This study needs to be continued further to a vast sample size to perfectly assess the statistical significance.


Author(s):  
Dang Tinh Pham ◽  
Thi Ngoc Le ◽  
Ton Ngoc Vu Phan ◽  
Parshal Bhandari ◽  
Sairah Zia ◽  
...  

OBJECTIVE The aim of this study was to access the influence of active warming after epidural anesthesia (EDA) and before general anesthesia in prevention of perioperative hypothermia. METHOD This randomized controlled trial was conducted in the department of anesthesiology in university medical center of Ho Chi Minh city, Vietnam from December 2019 until April 2020. This trial included 60 adult patients who were scheduled for major abdominal surgery with a duration of at least 120 minutes and under combined general anesthesia and EDA. Patients were excluded if age was below 18 years, American Society Anesthesiologists’ physical status classification of IV or higher, or refusal of EDA. Written informed consent was obtained for all patients. Patients were divided randomly into two groups. The first group received 10 minutes of active air-forced warming after EDA before the induction of general anesthesia. The second group was covered with a blanket 10 minutes after EDA and before general anesthesia. Core temperatures were recorded throughout the study. The primary outcome measures were the incidence of perioperative hypothermia and the degree of hypothermia. The secondary outcome measures were rate and time for body temperature to return to normal and incidence of postoperative body shivering. RESULTS Without active warming (n = 21), 70% of patients became hypothermic (<36°C) postoperatively. Active air-forced warming for 10 minutes after EDA and before induction of general anesthesia decreased the incidence of postoperative hypothermia to 26.7% (n = 8). CONCLUSION Active air-forced warming for 10 minutes after EDA and before induction of general anesthesia is efficient in reducing the incidence of perioperative hypothermia.


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