scholarly journals Analysis of the Impact of Intraoperative Margin Assessment with Adjunctive Use of MarginProbe versus Standard of Care on Tissue Volume Removed

2012 ◽  
Vol 2012 ◽  
pp. 1-4 ◽  
Author(s):  
Ronald J. Rivera ◽  
Dennis R. Holmes ◽  
Lorraine Tafra
Keyword(s):  
Controlled Trial ◽  
Local Therapy ◽  
Standard Of Care ◽  
Breast Conserving Surgery ◽  
Control Group ◽  
Tissue Volume ◽  
Initial Surgery ◽  
Cosmetic Outcomes ◽  
And Control ◽  
The Impact

Breast conserving surgery has been accepted as the optimal local therapy for women with early breast cancer, emphasizing the necessity to balance oncologic goals with patient satisfaction and cosmetic outcomes. In the move to enhance a surgeon's ability to achieve histologically clear margins intraoperatively at the initial surgery, the MarginProbe (Dune Medical Devices, Caesarea, Israel) has emerged as an effective tool to accomplish that task. Based on previously reported success using the device, we assessed cosmesis and tissue resection volumes among participants in a randomized-controlled trial comparing the standard of care lumpectomy performed with and without the MarginProbe. The use of the MarginProbe device resulted in a 57% reduction in reexcision rates compared to the control group with a small increase in tissue volume removed at the primary lumpectomy. When total tissue volumes removed were analyzed, the device and control groups were still very similar after normalization to bra cup size. We concluded that the MarginProbe is an effective device to assist surgeons in determining margin status intraoperatively while allowing for better patient cosmetic outcomes due to the smaller volumes of tissue resected and the reduction in patient referrals for second surgeries due to positive margins.

Abstract P186: A Randomized Preschool Trial To Promote Cardiovascular Health In Colombia: 18 Month Follow Up.

Circulation ◽  
2012 ◽  
Vol 125 (suppl_10) ◽  
Author(s):  
Jaime Céspedes ◽  
German Briceño ◽  
Michael Farkouh ◽  
Rajesh Vedanthan ◽  
Martha Leal ◽  
...  
Keyword(s):  
Educational Intervention ◽  
Cardiovascular Health ◽  
Controlled Trial ◽  
Intervention Group ◽  
Educational Programs ◽  
Control Group ◽  
Active Lifestyle ◽  
And Control ◽  
The Impact

Introduction: Educational programs for children can increase uptake of healthy lifestyle behaviors. However, the impact of educational programs in preschool-aged children in low- and middle-income countries is not known. We conducted a five month educational intervention in preschool facilities (PF) in Bogota, Colombia, to assess changes in preschooler’s knowledge, attitudes and habits (KAH) towards healthy eating and living an active lifestyle. Methods: We conducted a cluster, randomized, controlled trial, and randomly assigned 14 PF in Bogota to a five-month educational intervention (7 PF) or to usual curriculum (7 PF). The intervention included classroom activities and use of printed material and videos. A total of 1216 pre-school children, 928 parents, and 120 teachers participated. A structured survey was used to evaluate changes in KAH with a weighted total score (WTS). The primary outcome was change in children's WTS, and the secondary outcomes were change in parents’ and teachers' WTS. The control PF were provided the intervention after the initial evaluation. To assess sustainability, we evaluated both intervention and control groups at 18 months. Results: At 6 months, children in the intervention group showed 10.9% increase in WTS vs. 5.3% in controls, p<0.001, after adjustment for cluster, sex, age and teachers' educational level. Among parents, the equivalent results were 8.9% and 3.1%, respectively, p< 0.001, and among teachers 9.4% and 2.5%, p=0.06. At the 18-month extended follow-up, both the intervention and control children showed a significant further increase in WTS, p<0.001 (Figure 1). In parents and teachers in the intervened group, there was no significant increase in WTS, p=0.7417, and p=0.1197. In the control group, there was an increase in WTS in teachers but not in parents, p=0.001, and p=0.4239. Conclusion: A preschool based intervention, aimed at changing KAH related to healthy diet and active lifestyle, is feasible, efficacious and sustainable up to 18 months in very young children in Colombia.

O3 DIRECT ORAL FEEDING FOLLOWING MINIMALLY INVASIVE ESOPHAGECTOMY (NUTRIENT II TRIAL): AN INTERNATIONAL, MULTICENTER, OPEN-LABEL RANDOMIZED CONTROLLED TRIAL

2019 ◽  
Vol 32 (Supplement_2) ◽  
Author(s):  
Gijs H K Berkelmans ◽  
Laura F C Fransen ◽  
Annemarie C P Dolmans-Zwartjes ◽  
Ewout A Kouwenhoven ◽  
Marc J van Det ◽  
...  
Keyword(s):  
Anastomotic Leakage ◽  
Functional Recovery ◽  
Controlled Trial ◽  
Minimally Invasive Esophagectomy ◽  
Standard Of Care ◽  
Oral Feeding ◽  
Control Group ◽  
P Value ◽  
Invasive Esophagectomy ◽  
And Control

Abstract Aim Patients undergoing an esophagectomy are often kept nil-by-mouth postoperatively out of fear for increasing anastomotic leakage and pulmonary complications. This study investigates the effect of direct start of oral feeding following minimally invasive esophagectomy (MIE) compared to standard of care. Background & Methods Elements of enhanced recovery after surgery (ERAS) protocols have been successfully introduced in patients undergoing an esophagectomy. However, start of oral intake, which is an essential part of the ERAS protocols, remains a matter of debate. Patients in this multicenter, international randomized controlled trial were randomized to directly start oral feeding (intervention) after a MIE with intrathoracic anastomosis or to receive nil-by-mouth and tube feeding for five days postoperative (control group). Primary outcome was time to functional recovery. Secondary outcome parameters included anastomotic leakage, pneumonia rate and other surgical complications scored by predefined definitions. Results Baseline characteristics were similar in the intervention (n=65) and control (n=67) group. Functional recovery was seven days for patients receiving direct oral feeding compared to eight days in the control group (p-value 0.436). Anastomotic leakage rate did not differ in the intervention (18.5%) and control group (16.4%, p-value 0.757). Pneumonia rates were comparable between the intervention (24.6%) and control group (34.3%, p-value 0.221). Other morbidity rates were similar, except for chyle leakage which was more prevalent in the standard of care group (p-value 0.032). Conclusions Direct oral feeding after an esophagectomy does not affect functional recovery and did not increase incidence or severity of postoperative complications.

scholarly journals Effect of a Virtual Reality-enhanced Exercise and Education Intervention on Patient Engagement and Learning in Cardiac Rehabilitation: Randomized Controlled Trial (Preprint)

2020 ◽  
Author(s):  
Victoria Vavala ◽  
Daniel Graves ◽  
Shannon Ames ◽  
Pavitra Krishnamani
Keyword(s):  
Virtual Reality ◽  
Cardiac Rehabilitation ◽  
Patient Adherence ◽  
Controlled Trial ◽  
Intervention Group ◽  
Standard Of Care ◽  
Final Visit ◽  
Control Group ◽  
Satisfaction With Treatment ◽  
And Control

BACKGROUND Cardiac rehabilitation is clinically proven to reduce morbidity and mortality, but many patients do not attend treatment. Those who do attend frequently do not finish their full course of treatment. This is greatly influenced by socioeconomic factors but is also due to patients’ lack of understanding on the importance of their care and a lack of motivation to maintain attendance. OBJECTIVE The goal of this study was to explore the potential benefits of virtual reality (VR) walking trails within cardiac rehabilitation treatment, specifically on patient education retention, satisfaction with treatment, and overall attendance of treatment sessions. METHODS New cardiac rehabilitation patients were enrolled and randomized on a rolling basis to either control or intervention groups. Intervention patients completed time on the treadmill with VR walking trails, including audio recorded education; control patients completed standard of care therapy. Both groups were assisted by nursing staff for all treatment sessions. Primary outcomes were determined by assessing six-minute-walk-test (6MWT) improvement. Additionally, secondary outcomes of patients’ cardiac knowledge and satisfaction were assessed via computer-based questionnaire; patient adherence to recommended number of sessions was also monitored. Cardiac knowledge assessment included a pre-rehabilitation education quiz, the same quiz repeated at their final visit, and again at a 2-month follow up. The satisfaction questionnaire was completed at their final visit. RESULTS Between January 2018 and May 2019, 72 patients were enrolled, 41 to the intervention group and 31 to the control group. Based upon the results of the pre- and post-rehabilitation 6MWT, no differences were seen between intervention and control groups (P = .23). No statistical differences were seen between groups on education (P = .50) or satisfaction (P = .30) at any time point. The control group had statistically more favorable rates of attendance, both by risk group (P = .024) and by completion of minimum sessions (P = .046), but no correlation was seen between study group and reason for ending treatment. CONCLUSIONS While no improvements were seen in the VR intervention group over the control group, it is worth noting that limitations in the study design may have influenced these outcomes, not the medium itself. Furthermore, qualitative information suggests that patients may have indeed enjoyed their experience with VR in a way that the quantitative data in this study may not have captured. Suggested within this paper are further considerations of how and when VR should be applied to cardiac rehabilitation. CLINICALTRIAL ClinicalTrials.gov NCT03945201

A Randomized Controlled Trial of the Effects of Group Conversation Treatment on Monologic Discourse in Aphasia

2021 ◽  
pp. 1-15
Author(s):  
Elizabeth Hoover ◽  
Gayle DeDe ◽  
Edwin Maas
Keyword(s):  
Randomized Controlled Trial ◽  
Narrative Analysis ◽  
Group Treatment ◽  
Controlled Trial ◽  
Primary Outcome Measure ◽  
Control Group ◽  
Percent Correct ◽  
Randomized Controlled ◽  
And Control ◽  
The Impact

Purpose Evidence has shown that group conversation treatment may improve communication and reduce social isolation for people with aphasia. However, little is known about the impact of conversation group treatment on measures of discourse. This project explored the impact of conversation treatment on measures of monologic discourse. Method In this randomized controlled trial, 48 participants with chronic aphasia were randomly assigned to dyadic, large group, or control conditions. Conversation group treatment was provided for 1 hr, twice per week, for 10 weeks. Discourse samples were collected and coded at pretreatment, posttreatment, and 6-week maintenance. There were three narrative tasks: (a) Comprehensive Aphasia Test (CAT) picture description, (b) Cat Rescue Picture, and (c) Cinderella retell. All narratives were coded using the percent correct information units (percent CIUs), the CAT standardized narrative analysis method, and the complete utterance (CU) method. Results No significant changes were observed on percent CIU, which was the primary outcome measure. The treated groups demonstrated improvement on aspects of the CU method following treatment, whereas the control group did not. Significant changes were observed for other CIU measures and the CAT standardized narrative analysis in both the treated and control groups. Conclusions The results suggest that the CU measures were more sensitive to the effects of conversation treatment in monologic discourse compared to CIU and CAT measures. Changes were more common in absolute rather than relative values, suggesting that conversation treatment impacts the overall amount of language produced rather than efficiency of production.

Reduced re-excisions while conserving tissue volume resected in DCIS patients.

2012 ◽  
Vol 30 (27_suppl) ◽  
pp. 144-144
Author(s):  
Beth Cutler Freedman ◽  
Susan K. Boolbol ◽  
Costanza Cocilovo ◽  
Lorraine Tafra
Keyword(s):  
Ductal Carcinoma ◽  
Breast Conservation ◽  
Positive Margin ◽  
Standard Of Care ◽  
Control Group ◽  
Tissue Volume ◽  
Novel Device ◽  
Device Use ◽  
The Impact ◽  
Total Tissue

144 Background: The ability to obtain negative margins with a single surgical procedure remains a challenge, particularly in patients with ductal carcinoma in situ (DCIS). Many techniques have been reported to lower the positive margin rate, at a cost of additional tissue resected. A novel device (MarginProbe, Dune Medical Devices, Inc.) is intended to provide surgeons with real time, intraoperative detection of cancerous tissues at the margins of excised specimens. An analysis was performed to determine the impact on tissue volume of the previously reported improvement in candidates for re-excision associated with device use for patients with a DCIS component. Methods: 596 patients undergoing breast conservation using wire localization were randomized in a prospective, international, multicenter (n=21) study. Randomization occurred in the operating room, following standard of care lumpectomy, including palpation and any indicated additional resections. Positive readings required additional resections of the cavity; device was used on main lumpectomy specimen only. Pathologists were blinded to study arm. Tissue volume of all specimens and resections was recorded. Since reducing candidates for re-excision requires removing additional tissue associated with cancer, we looked at total tissue volume removed across all surgeries, to assess the final impact to the patient. Results: Total tissue volumes removed during all surgeries (lumpectomy and re-excisions) for patients with DCIS alone was similar between the study group and control group, while the decrease in candidates for re-excision was significant (13% vs. 37%, p=0.004). For patients with DCIS and invasive carcinoma, the total volume excised was also similar, and the decrease in re-excision candidates was significant (13% vs. 33%, p<0.001). Conclusions: Unlike other techniques for reducing re-excisions, device use does not require an increase in tissue volume to achieve a significant reduction in the number of candidates for re-excision. [Table: see text]

scholarly journals Randomized Controlled Trial Study of the Impact of a Spiritual Intervention on Hope and Spiritual Well-Being of Persons with Cancer

2021 ◽  
Vol 39 (3) ◽  
Author(s):  
Ardashir Afrasiabifar ◽  
Asadollah Mosavi ◽  
Abolfazl Taghipour Jahromi ◽  
Nazafarin Hosseini
Keyword(s):  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Well Being ◽  
Control Group ◽  
Randomized Controlled ◽  
Before And After ◽  
Spiritual Well Being ◽  
Spiritual Intervention ◽  
And Control ◽  
The Impact

Objective. To determine the impact of spiritual intervention on hope and spiritual well-being of persons with cancer Methods. Randomized controlled trial in which 74 patients with cancer referring to a chemotherapy ward of Shahid Rajaie Hospital in Yasuj city, Iran, were participated. The eligible patients were randomly assigned to either intervention or control group. Spiritual-based intervention was performed based on the protocol in four main fields namely; religious, existence, emotional and social over 5 sessions before chemotherapy.The participants in the control group had received usual cares .Data were collected using Snyder's Hope Scale and Ellison's Scale Spiritual Well-Being Scale on a week before and after intervention. Results. The total mean scores of the scales of hope and spiritual well-being in both groups did not present statistical differences in the pre-intervention assessment. In contrast, at the post assessment, significant differences (p<0.001) were found in the mean scores between the intervention and control groups on the hope scale (60.9 versus 39.8) and on the spiritual well-being scale (94.3 versus 71.6). Conclusion. Spiritual intervention could promote hope and spiritual well-being of persons with cancer.

Cognitive Therapy and Recovery from Acute Psychosis: a Controlled Trial

1996 ◽  
Vol 169 (5) ◽  
pp. 602-607 ◽  
Author(s):  
Val Drury ◽  
Max Birchwood ◽  
Ray Cochrane ◽  
Fiona MacMillan
Keyword(s):  
Controlled Trial ◽  
Control Group ◽  
Positive Symptoms ◽  
Acute Psychosis ◽  
Low Level ◽  
Clinical Recovery ◽  
Clinical Models ◽  
And Control ◽  
The Impact ◽  
Degree Of Recovery

BackgroundA trial of CT in acute psychosis conducted by the authors has shown a significant impact on the rate and degree of recovery of positive symptoms, the focus of the intervention. This paper seeks to determine whether these effects generalise to other features of acute psychosis including dysphoria, insight and ‘low level’ psychotic thinking which were not directly targeted.MethodMeasures of dysphoria, insight and psychotic thinking were taken over a six-month period following presentation for acute psychosis. Using survival analysis, time to recovery from psychosis using three definitions of increasing stringency was compared between the CT and control group.ResultsCT was associated with a 25–50% reduction in recovery time depending on the definition used.ConclusionThe impact of the CT intervention extended beyond positive symptoms to include insight, dysphoria and ‘low level’ psychotic thinking. Nevertheless this kind of ‘clinical’ recovery required a median of 20 weeks to complete. Implications for clinical models of acute care are discussed.

scholarly journals Optimal wound closure of diabetic foot ulcers with early initiation of TLC-NOSF treatment: post-hoc analysis of Explorer

2019 ◽  
Vol 28 (6) ◽  
pp. 358-367 ◽  
Author(s):  
José Luis Lázaro-Martínez ◽  
Michael Edmonds ◽  
Gerry Rayman ◽  
Jan Apelqvist ◽  
Kristien Van Acker ◽  
...  
Keyword(s):  
Diabetic Foot ◽  
Wound Closure ◽  
Controlled Trial ◽  
Standard Of Care ◽  
Foot Ulcers ◽  
Control Group ◽  
Diabetic Foot Ulcers ◽  
Post Hoc Analysis ◽  
Post Hoc ◽  
The Impact

Objective: In March 2018, the Explorer study, an international, double-blind, randomised controlled trial (RCT), established that adding a TLC-NOSF (UrgoStart Contact, Laboratoires Urgo, France) dressing to good local standard of care (SoC) significantly and substantially increases wound closure and reduces the healing time of neuroischaemic diabetic foot ulcers (DFU). Besides the TLC-NOSF treatment, the wound duration was the only other covariate that had an influence on the wound closure rate in the regression model used in the original study. The purpose of this work was to further document the impact of wound duration on the healing outcomes of the DFUs included in the Explorer study and to discuss complementary pragmatic observations on the TLC-NOSF effect. Method: In this post-hoc analysis of the Explorer data, the wound closure rates by week 20 are reported for the global cohort (n=240, Intention-to-treat population) and for the treated (n=126) and control groups (n=114) according to DFU duration and location. Results: For the combined group, wound closure rates decreased with the increase of wound duration at baseline (from 57% in wounds ≤2 months to 19% in wounds >11 months). Whatever the wound duration subgroups analysed, higher closure rates were reported in the TLC-NOSF group than in the control group. However, the maximal difference between the two treatments was reported in wounds with a duration of ≤2 months (71% versus 41%, 30 percentage points difference, Relative Risk 1.7, 95% Confidence Interval 1.1 to 2.8). Regarding wound location subgroup analyses, the outcomes were always in favour of the TLC-NOSF treatment, with closure rates ranging between 43% and 61% within the TLC-NOSF group, and between 25% and 40% within the control group. Conclusion: This clinical evidence supports that treating DFUs with TLC-NOSF dressing and good SoC results in higher wound closure rates than with a neutral dressing and the same good standard of care, whatever the duration and the location of the treated wounds. However, the earlier the TLC-NOSF dressing is initiated in DFU treatment, the greater the benefits.

scholarly journals Corticosteroid Resistance in Smokers—A Substudy Analysis of the CORTICO-COP Randomised Controlled Trial

2021 ◽  
Vol 10 (12) ◽  
pp. 2734
Author(s):  
Pradeesh Sivapalan ◽  
Andras Bikov ◽  
Charlotte Suppli Ulrik ◽  
Therese Sophie Lapperre ◽  
Alexander G. Mathioudakis ◽  
...  
Keyword(s):  
Smoking Status ◽  
Controlled Trial ◽  
Standard Of Care ◽  
Control Group ◽  
Chronic Obstructive ◽  
Obstructive Pulmonary Disease ◽  
Corticosteroid Resistance ◽  
Significant Difference ◽  
Randomised Controlled ◽  
The Impact

The CORTICO-COP trial showed that eosinophil-guided corticosteroid-sparing treatment for acute exacerbation of chronic obstructive pulmonary disease was non-inferior to standard of care and decreased the accumulated dose of systemic corticosteroids that patients were exposed to by approximately 60%. Smoking status has been shown to affect corticosteroid responsiveness. This post hoc analysis investigated whether eosinophil-guided treatment is non-inferior to conventional treatment in current smokers. The main analysis of current smokers showed no significant difference in the primary endpoint, days alive, and out of hospital within 14 days between the control group (mean, 9.8 days; 95% confidence interval (CI), 8.7–10.8) and the eosinophil-guided group (mean, 8.7 days; 95% CI, 7.5–9.9; p = 0.34). Secondary analyses of the number of exacerbations or deaths, the number of intensive care unit admissions or deaths, lung function improvement, and change in health-related quality of life also showed no significant differences between the two groups. The results of a sensitivity analysis of ex-smokers are consistent with the main analysis. Our results suggest that eosinophil-guided treatment is non-inferior to standard of care in current smokers and ex-smokers. Because data on the impact of smoking status on eosinophil-guided treatments are sparse, more randomised trials are needed to confirm our results.

scholarly journals A multicenter, randomized, open-label, controlled trial to evaluate the efficacy and tolerability of hydroxychloroquine and a retrospective study in adult patients with mild to moderate coronavirus disease 2019 (COVID-19)

PLoS ONE ◽  
2020 ◽  
Vol 15 (12) ◽  
pp. e0242763 ◽  
Author(s):  
Cheng-Pin Chen ◽  
Yi-Chun Lin ◽  
Tsung-Chia Chen ◽  
Ting-Yu Tseng ◽  
Hon-Lai Wong ◽  
...  
Keyword(s):  
Retrospective Study ◽  
Controlled Trial ◽  
Standard Of Care ◽  
Public Hospitals ◽  
Control Group ◽  
Rt Pcr ◽  
Open Label ◽  
Viral Shedding ◽  
Randomized Controlled ◽  
And Control

Objective In this study, we evaluated the efficacy of hydroxychloroquine (HCQ) against coronavirus disease 2019 (COVID-19) via a randomized controlled trial (RCT) and a retrospective study. Methods Subjects admitted to 11 designated public hospitals in Taiwan between April 1 and May 31, 2020, with COVID-19 diagnosis confirmed by pharyngeal real-time RT-PCR for SARS-CoV-2, were randomized at a 2:1 ratio and stratified by mild or moderate illness. HCQ (400 mg twice for 1 d or HCQ 200 mg twice daily for 6 days) was administered. Both the study and control group received standard of care (SOC). Pharyngeal swabs and sputum were collected every other day. The proportion and time to negative viral PCR were assessed on day 14. In the retrospective study, medical records were reviewed for patients admitted before March 31, 2020. Results There were 33 and 37 cases in the RCT and retrospective study, respectively. In the RCT, the median times to negative rRT-PCR from randomization to hospital day 14 were 5 days (95% CI; 1, 9 days) and 10 days (95% CI; 2, 12 days) for the HCQ and SOC groups, respectively (p = 0.40). On day 14, 81.0% (17/21) and 75.0% (9/12) of the subjects in the HCQ and SOC groups, respectively, had undetected virus (p = 0.36). In the retrospective study, 12 (42.9%) in the HCQ group and 5 (55.6%) in the control group had negative rRT-PCR results on hospital day 14 (p = 0.70). Conclusions Neither study demonstrated that HCQ shortened viral shedding in mild to moderate COVID-19 subjects.

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