scholarly journals A Randomized Controlled Trial of Enhanced Cleaning to Reduce Contamination of Healthcare Worker Gowns and Gloves with Multidrug-Resistant Bacteria

2013 ◽  
Vol 34 (5) ◽  
pp. 487-493 ◽  
Author(s):  
Aaron S. Hess ◽  
Michelle Shardell ◽  
J. Kristie Johnson ◽  
Kerri A. Thom ◽  
Mary-Claire Roghmann ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Relative Risk ◽  
Confidence Interval ◽  
Healthcare Worker ◽  
Controlled Trial ◽  
Multidrug Resistant ◽  
Resistant Bacteria ◽  
Randomized Controlled ◽  
The Mean ◽  
Control Rooms

Objective.To determine whether enhanced daily cleaning would reduce contamination of healthcare worker (HCW) gowns and gloves with methicillin-resistant Staphylococcus aureus (MRSA) or multidrug-resistant Acinetobacter baumannii (MDRAB).Design.A cluster-randomized controlled trial.Setting.Four intensive care units (ICUs) in an urban tertiary care hospital.PARTICIPANTS.ICU rooms occupied by patients colonized with MRSA or MDRAB.INTERVENTION.Extra enhanced daily cleaning of ICU room surfaces frequently touched by HCWs.Results.A total of 4,444 cultures were collected from 132 rooms over 10 months. Using fluorescent dot markers at 2,199 surfaces, we found that 26% of surfaces in control rooms were cleaned and that 100% of surfaces in experimental rooms were cleaned (P < .001). The mean proportion of contaminated HCW gowns and gloves following routine care provision and before leaving the rooms of patients with MDRAB was 16% among control rooms and 12% among experimental rooms (relative risk, 0.77 [95% confidence interval, 0.28-2.11]; P = .23). For MRSA, the mean proportions were 22% and 19%, respectively (relative risk, 0.89 [95% confidence interval, 0.50-1.53]; P = .16).Discussion.Intense enhanced daily cleaning of ICU rooms occupied by patients colonized with MRSA or MDRAB was associated with a nonsignificant reduction in contamination of HCW gowns and gloves after routine patient care activities. Further research is needed to determine whether intense environmental cleaning will lead to significant reductions and fewer infections.Trial Registration.ClinicalTrials.gov identifier: NCT01481935.

The effectiveness of emotional freedom techniques (EFT) on depression of postmenopausal women: a randomized controlled trial

2021 ◽  
Vol 0 (0) ◽  
Author(s):  
Asieh Mehdipour ◽  
Parvin Abedi ◽  
Somayeh Ansari ◽  
Maryam Dastoorpoor
Keyword(s):  
Randomized Controlled Trial ◽  
Postmenopausal Women ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Randomized Controlled ◽  
Moderate Depression ◽  
Before And After ◽  
The Mean ◽  
And Control

Abstract Objectives Postmenopausal women are at greater risk of depression. Depression may negatively affect the quality of life of women. An emotional freedom technique (EFT) is an evidence-based therapy combining cognitive and exposure components with acupressure. This study aimed to evaluate the effect of EFT on depression in postmenopausal women. Methods This was a randomized controlled trial in which 88 women with mild to moderate depression recruited from a menopausal clinic in Ahvaz, Iran, and randomly assigned into two groups of EFT (n=44) and control for sham therapy (n=44). Women in the EFT group received two sessions of training and asked to continue EFT for 8 weeks, one time per day. The Beck Depression Inventory (BDI2) completed by women before and after the intervention. The control group received training on sham acupressure points similar to the intervention group. Data collected using a demographic and BDI2. Women requested to complete the BDI2 before and after the intervention. The independent t-test, chi-square, and ANCOVA were used to analyze data. Results The mean depression score in the intervention group reduced from 20.93 ± 4.6 to 10.96 ± 4.38 in comparison to the control group that reduced from 19.18 ± 2.79 to 17.01 ± 6.05 after intervention (p=0.001). After the 8 week intervention, the frequency of moderate depression decreased from 56.8 to 9.35% in the intervention and from 50 to 29.5% in the control group. In total, 63.4 and 34.15% in the intervention and control groups were free of depression respectively after the intervention (p<0.001). Conclusions The results of this study showed that using EFT for 8 weeks could significantly reduce the mean score of depression in postmenopausal women. Using this method in public health centers for postmenopausal women is recommended.

scholarly journals Results Are Similar Two Years After Acute or Delayed Anterior Cruciate Ligament Reconstruction. A Randomized Controlled Trial

2017 ◽  
Vol 5 (5_suppl5) ◽  
pp. 2325967117S0017
Author(s):  
Karl Eriksson ◽  
Christoffer von Essen ◽  
Björn Barenius
Keyword(s):  
Randomized Controlled Trial ◽  
Primary Endpoint ◽  
Pivot Shift ◽  
Controlled Trial ◽  
Acl Injury ◽  
Activity Level ◽  
Randomized Controlled ◽  
Delayed Group ◽  
The Mean

Objectives: Acute ACLR has been avoided since the 1990’s due to reports of postoperative stiffness. But are these risks still valid with modern arthroscopic techniques? The aim of this randomized controlled trial was to assess the impact of the time between injury and reconstruction on the outcome after ACLR. Our hypothesis was that acute ACLR with semitendinosus graft can be performed safely. Methods: The primary endpoint was ROM at three months after surgery. A power calculation revealed the need for 64 patients to detect a ROM difference of 5 degrees between the groups (5% significance level). 70 patients with a high recreational activity level (Tegner ≥6) who presented with an acute ACL injury were randomized to an acute reconstruction within 8 days from the injury or delayed reconstruction (after normalized ROM) 6-10 weeks after the injury. Fixation was with Endobutton in femur and a metallic interference screw in tibia. The rehabilitation was performed at the same physiotherapy center for all patients. Follow up assessment was performed by a physiotherapist not involved with the rehabilitation. The follow up at 24 months included ROM, Lachman, instrumented laxity with Rolimeter, pivot shift, one leg hop index, Biodex, IKDC, KOOS, Lysholm and Tegner Activity level, and a VAS question regarding knee function and the knee function’s effect on activity level. Results: Seventy percent of the patients were males, mean age at the time of surgery was 27 years (18 -41) and the median pre-injury Tegner level was 9 (6-10) with no differences between the groups. 64 (91%) patients were assessed at three months with no difference according to the primary endpoint. Median Tegner level was restored to pre-injury levels in both groups after one year, and did not change between one and two years. 63 (90%) patients were available for the 2-year follow up. There was one graft rupture and one contralateral ACL injury in both groups. There was additional surgery in 15% of the acute patients and in 31% in the delayed (n.s.). The mean instrumented laxity was 1.8 mm in the acute and 2.0 in the delayed group. There were no positive pivot shift in the acute group and 6 patients with grade 1 or not possible to perform in the delayed group (p=0.039). IKDC revealed no significant differences between the groups. Lysholm score was 87 in both groups. KOOS values showed no significant difference between the groups. VAS response to the question “How is your knee working on a scale from 0-100? (100 = best)” was 81 in the acute and 71 in the delayed group (p=0.1) and “How does your knee affect your activity level? (100 = no affection)” the mean score was 75 in the acute and 67 in the delayed group (p=0.3). Functional strength (one leg hop index >90%) was 85% in the acute and 67% in the delayed group (n.s). Conclusion: We found no increased risk of arthrofibrosis after acute ACLR. Good results can be achieved at two years regardless of ROM and swelling in the acute stage.

scholarly journals A Randomized Controlled Trial of Daily and Weekly Iron Supplementations for Improving Iron Status in the Infants

2021 ◽  
Author(s):  
Nalinee Pattrakornkul ◽  
Parichaya Ngamcherdtrakul ◽  
Warawut Kriangburapa ◽  
Siriporn Tangjaturonrasme ◽  
Ramorn Yampratoom
Keyword(s):  
Randomized Controlled Trial ◽  
Iron Deficiency ◽  
Iron Supplementation ◽  
Iron Status ◽  
Controlled Trial ◽  
Daily Group ◽  
Randomized Controlled ◽  
The Mean ◽  
Mean Differences ◽  
Weekly Group

Abstract Background: Iron deficiency anemia screening and iron supplementation in infants aged 6-12 months are recommended in the Guideline in Child Health Supervision. This study aims to evaluate the effectiveness of weekly iron supplementation compared with daily supplementation in improving the iron status in infants.Methods: A single-blind randomized controlled trial was conducted in infants aged 6 months visiting the Well Child Clinic between May 2019 and November 2020 at Burapha University Hospital, Chonburi, Thailand. The intervention consisted of either daily or weekly iron supplementation combined with iron-rich complementary food promotion for six months. The outcomes were the differences of serum ferritin and hematological variables before and after being iron supplemented. Results: Sixty-nine six-month-old healthy infants were randomized to receive either 10 mg Fe/day (daily group) or 30 mg Fe/week (weekly group). Forty-five infants (daily group; n = 24 and weekly group; n = 21) completed the intervention. After the six-month period of iron supplementation, the mean differences of serum ferritin in the daily and the weekly group were 8.78±37.21 and -13.05 ±17.53 ng/mL, respectively (95%CI: 4.54, 39.12; P=0.015). The mean differences of hemoglobin in the daily and the weekly group were 0.58±0.82 and 0.08±0.59 g/dL, respectively (95%CI: 0.06, 0.93; P=0.026). Daily supplementation could prevent iron deficiency more than weekly supplementation significantly (P=0.029), particularly in the exclusive breastfeeding subgroup (P=0.032).Conclusions: Daily iron supplementation is more effective than weekly iron supplementation in improving iron status and hemoglobin level in infants, especially in the exclusively breast-feds.Trial registration: TCTR20191107001, November 7th, 2019. Retrospectively registered, http://www.thaiclinicaltrials.org

scholarly journals Randomized Controlled Trial of Tailored Music Listening Intervention for Sleep in Dementia

2020 ◽  
Vol 4 (Supplement_1) ◽  
pp. 215-215
Author(s):  
Darina Petrovsky ◽  
Shana Roan ◽  
Nalaka Gooneratne ◽  
Joke Bradt ◽  
Laura Gitlin ◽  
...  
Keyword(s):  
Older Adults ◽  
Randomized Controlled Trial ◽  
African American ◽  
Controlled Trial ◽  
Sleep Disruption ◽  
Music Listening ◽  
Music Intervention ◽  
Clinical Dementia Rating ◽  
Randomized Controlled ◽  
The Mean

Abstract Sleep disruption in older adults living with Alzheimer’s disease and related dementias (ADRD) is debilitating and contributes to increased institutionalization, reduced cognitive function, and accelerated disease progression. Given the potential harmful effects of pharmacologic treatment, non-pharmacologic approaches, such as music, may provide a safer alternative to improve sleep quality in this vulnerable population. No empirically validated music protocol exists to address sleep disruption in older adults with ADRD living at home. Therefore, the specific aims of this wait-list randomized controlled trial were to examine the 1) feasibility; 2) acceptability; and 3) preliminary efficacy of a tailored music intervention in home-dwelling older adults with ADRD with sleep disruption and their caregivers. This presentation focuses on baseline characteristics of dyads, which included persons with ADRD and their caregivers who have completed the clinical trial so far (N=28). The mean age of persons with ADRD was 71.6 (SD: 7.6). The mean age of caregivers was 58.7 (SD: 16.7). Sixty-eight percent (n=19) of persons with ADRD were female. Similarly, the majority of caregivers were female (n=20, 71.4%). Seventy-four percent of persons with ADRD scored 0.5 on the Clinical Dementia Rating instrument, indicative of very mild dementia. The majority of dyads identified themselves as non-Hispanic (&gt;92%). Seventy-nine percent of persons with ADRD identified themselves as Black or African-American (n=22, 79%), while 82.1% of caregivers identified themselves as Black or African American. Preliminary analysis of qualitative data indicates high acceptability of the intervention. Results from this research study will inform a future efficacy trial.

scholarly journals A randomized controlled trial comparing oxytocin administration before and after placental delivery in the prevention of postpartum haemorrhage in a tertiary care hospital in Bankura district of West Bengal, India

2020 ◽  
Vol 9 (5) ◽  
pp. 1976
Author(s):  
Rahul Kirtania ◽  
Jayita Pal ◽  
Sisir Biswas ◽  
Aditi Aich
Keyword(s):  
Randomized Controlled Trial ◽  
Blood Loss ◽  
Controlled Trial ◽  
Active Management ◽  
Control Group ◽  
Care Hospital ◽  
Normal Delivery ◽  
Randomized Controlled ◽  
Significant Difference ◽  
The Mean

Background: PPH is the prime cause of maternal mortality worldwide. The incidence of PPH can be drastically combatted by application of uterotonic in active management of third stage labour. Timing of its administration is a matter of concern. This study aimed to assess whether timing of administration of oxytocin would have any impact on incidence or mean blood loss of PPH.Methods: It was a single blinded randomized controlled trial conducted in the department of Obstetrics and Gynecology, Bankura Sammilani Medical College for 6 months where 100 antenatal mothers admitted for normal delivery in labour room were allocated randomly in study and control group considering inclusion and exclusion criteria. Incidence of PPH and mean blood loss had been identified clinically by following them for 24 hours.Results: Only 9% of study population had experienced PPH. There was no statistically significant difference in incidence of PPH with difference in timing of administration of oxytocin (p >0.05). But there was statistically significant decrease in mean blood loss if oxytocin was administered before the placental delivery. The mean blood loss with oxytocin administered before placental delivery was 296.8 ml (102.45) and after placental delivery was 452.0 (128.87) ml respectively.Conclusions: Policy makers should keep in mind not only the incidence of PPH, but the mean blood loss amount too in a setting where anaemia in pregnancy is quite prevalent.

scholarly journals Increasing response rates to follow-up questionnaires in health intervention research: Randomized controlled trial of a gift card prize incentive

2017 ◽  
Vol 14 (4) ◽  
pp. 381-386 ◽  
Author(s):  
Amy J Morgan ◽  
Ronald M Rapee ◽  
Jordana K Bayer
Keyword(s):  
Randomized Controlled Trial ◽  
Confidence Interval ◽  
Odds Ratio ◽  
Response Rate ◽  
Controlled Trial ◽  
Response Rates ◽  
Health Intervention ◽  
Randomized Controlled ◽  
Gift Card

Background/aims Achieving a high response rate to follow-up questionnaires in randomized controlled trials of interventions is important for study validity. Few studies have tested the value of incentives in increasing response rates to online questionnaires in clinical trials of health interventions. This study evaluated the effect of a gift card prize-draw incentive on response rates to follow-up questionnaires within a trial of an online health intervention. Method The study was embedded in a host randomized controlled trial of an online parenting program for child anxiety. A total of 433 participants were randomly allocated to one of two groups: (1) being informed that they would enter a gift card prize-draw if they completed the final study questionnaire (24-week follow-up) and (2) not informed about the prize-draw. All participants had a 1 in 20 chance of winning an AUD50 gift card after they completed the online questionnaire. Results The odds of the informed group completing the follow-up questionnaire were significantly higher than the uninformed group, (79.6% vs 68.5%, odds ratio = 1.79, 95% confidence interval = 1.15–2.79). This response rate increase of 11.1% (95% confidence interval = 2.8–19.1) occurred in both intervention and control groups in the host randomized controlled trial. The incentive was also effective in increasing questionnaire commencement (84.6% vs 75.9%, odds ratio = 1.74, 95% confidence interval = 1.07–2.84) and reducing the delay in completing the questionnaire (19.9 vs 22.6 days, hazard ratio = 1.34, 95% confidence interval = 1.07–1.67). Conclusion This study adds to evidence for the effectiveness of incentives to increase response rates to follow-up questionnaires in health intervention trials.

scholarly journals Hydroxychloroquine for Early Treatment of Adults With Mild Coronavirus Disease 2019: A Randomized, Controlled Trial

2020 ◽  
Author(s):  
Oriol Mitjà ◽  
Marc Corbacho-Monné ◽  
Maria Ubals ◽  
Cristian Tebé ◽  
Judith Peñafiel ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Viral Load ◽  
Adverse Events ◽  
Usual Care ◽  
Symptom Onset ◽  
Early Treatment ◽  
Complete Resolution ◽  
Controlled Trial ◽  
Randomized Controlled ◽  
The Mean

Abstract Background No effective treatments for coronavirus disease 2019 (COVID-19) exist. We aimed to determine whether early treatment with hydroxychloroquine (HCQ) would be efficacious for outpatients with COVID-19. Methods Multicenter open-label, randomized, controlled trial conducted in Catalonia, Spain, between 17 March and 26 May 2020. Patients recently diagnosed with &lt;5-day of symptom onset were assigned to receive HCQ (800 mg on day 1 followed by 400 mg once daily for 6 days) or usual care. Outcomes were reduction of viral load in nasopharyngeal swabs up to 7 days after treatment start, disease progression up to 28 days, and time to complete resolution of symptoms. Adverse events were assessed up to 28 days. Results A total of 293 patients were eligible for intention-to-treat analysis: 157 in the control arm and 136 in the intervention arm. The mean age was 41.6 years (SD, 12.6), mean viral load at baseline was 7.90 log10 copies/mL (SD, 1.82), and median time from symptom onset to randomization was 3 days. No differences were found in the mean reduction of viral load at day 3 (−1.41 vs −1.41 log10 copies/mL in the control and intervention arm, respectively) or at day 7 (−3.37 vs −3.44). Treatment did not reduce risk of hospitalization (7.1% control vs 5.9% intervention) nor shorten the time to complete resolution of symptoms (12 days, control vs 10 days, intervention). No relevant adverse events were reported. Conclusions In patients with mild COVID-19, no benefit was observed with HCQ beyond the usual care.

scholarly journals Randomized, Controlled Trial Comparing Mitral Valve Repair With Leaflet Resection Versus Leaflet Preservation on Functional Mitral Stenosis

Circulation ◽  
2020 ◽  
Vol 142 (14) ◽  
pp. 1342-1350
Author(s):  
Vincent Chan ◽  
C. David Mazer ◽  
Faeez Mohamad Ali ◽  
Adrian Quan ◽  
Marc Ruel ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Mitral Valve ◽  
Mitral Regurgitation ◽  
Mitral Stenosis ◽  
Controlled Trial ◽  
Walking Distance ◽  
Peak Exercise ◽  
Unique Identifier ◽  
Randomized Controlled ◽  
The Mean

Background: Equipoise exists between the use of leaflet resection and preservation for surgical repair of mitral regurgitation caused by prolapse. We therefore performed a randomized, controlled trial comparing these 2 techniques, particularly in regard to functional mitral stenosis. Methods: One hundred four patients with degenerative mitral regurgitation surgically amenable to either leaflet resection or preservation were randomized at 7 specialized cardiac surgical centers. Exclusion criteria included anterior leaflet or commissural prolapse, as well as a mixed cause for mitral valve disease. Using previous data, we determined that a sample size of 88 subjects would provide 90% power to detect a 5–mm Hg difference in mean mitral valve gradient at peak exercise, assuming an SD of 6.7 mm with a 2-sided test with α=5% and 10% patient attrition. The primary end point was the mean mitral gradient at peak exercise 12 months after repair. Results: Patient age, proportion who were female, and Society of Thoracic Surgeons risk score were 63.9±10.4 years, 19%, and 1.4±2.8% for those who were assigned to leaflet resection (n=54), and 66.3±10.8 years, 16%, and 1.9±2.6% for those who underwent leaflet preservation (n=50). There were no perioperative deaths or conversions to replacement. At 12 months, moderate mitral regurgitation was observed in 3 subjects in the leaflet resection group and 2 in the leaflet preservation group. The mean transmitral gradient at 12 months during peak exercise was 9.1±5.2 mm Hg after leaflet resection and 8.3±3.3 mm Hg after leaflet preservation ( P =0.43). The participants had similar resting peak (8.3±4.4 mm Hg versus 8.4±2.6 mm Hg; P =0.96) and mean resting (3.2±1.9 mm Hg versus 3.1±1.1 mm Hg; P =0.67) mitral gradients after leaflet resection and leaflet preservation, respectively. The 6-minute walking distance was 451±147 m for those in the leaflet resection versus 481±95 m for the leaflet preservation group ( P =0.27). Conclusions: In this adequately powered randomized trial, repair of mitral prolapse with either leaflet resection or leaflet preservation was associated with similar transmitral gradients at peak exercise at 12 months postoperatively. These data do not support the hypothesis that a strategy of leaflet resection (versus preservation) is associated with a risk of functional mitral stenosis. Registration: URL: https://www.clinicaltrials.gov ; Unique identifier NCT02552771.

A randomized controlled trial with 4-month follow-up of adjunctive repetitive transcranial magnetic stimulation of the left prefrontal cortex for depression

2007 ◽  
Vol 38 (3) ◽  
pp. 323-333 ◽  
Author(s):  
A. Mogg ◽  
G. Pluck ◽  
S. V. Eranti ◽  
S. Landau ◽  
R. Purvis ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Magnetic Stimulation ◽  
Sham Group ◽  
Rating Scale ◽  
Repetitive Transcranial Magnetic Stimulation ◽  
Controlled Trial ◽  
Randomized Controlled ◽  
Real Group ◽  
The Mean

BackgroundEffectiveness of repetitive transcranial magnetic stimulation (rTMS) for major depression is unclear. The authors performed a randomized controlled trial comparing real and sham adjunctive rTMS with 4-month follow-up.MethodFifty-nine patients with major depression were randomly assigned to a 10-day course of either real (n=29) or sham (n=30) rTMS of the left dorsolateral prefrontal cortex (DLPFC). Primary outcome measures were the 17-item Hamilton Depression Rating Scale (HAMD) and proportions of patients meeting criteria for response (⩾50% reduction in HAMD) and remission (HAMD⩽8) after treatment. Secondary outcomes included mood self-ratings on Beck Depression Inventory-II and visual analogue mood scales, Brief Psychiatric Rating Scale (BPRS) score, and both self-reported and observer-rated cognitive changes. Patients had 6-week and 4-month follow-ups.ResultsOverall, Hamilton Depression Rating Scale (HAMD) scores were modestly reduced in both groups but with no significant group×time interaction (p=0.09) or group main effect (p=0.85); the mean difference in HAMD change scores was −0.3 (95% CI −3.4 to 2.8). At end-of-treatment time-point, 32% of the real group were responders compared with 10% of the sham group (p=0.06); 25% of the real group met the remission criterion compared with 10% of the sham group (p=0.2); the mean difference in HAMD change scores was 2.9 (95% CI −0.7 to 6.5). There were no significant differences between the two groups on any secondary outcome measures. Blinding was difficult to maintain for both patients and raters.ConclusionsAdjunctive rTMS of the left DLPFC could not be shown to be more effective than sham rTMS for treating depression.

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