scholarly journals LO45: Does the use of point of care ultrasonography improve survival in emergency department patients with undifferentiated hypotension? The first Sonography in Hypotension and Cardiac Arrest in the Emergency Department (SHOC-ED1) Study; an international randomized controlled trial

CJEM ◽  
2017 ◽  
Vol 19 (S1) ◽  
pp. S43
Author(s):  
P.R. Atkinson ◽  
J. Milne ◽  
L. Diegelmann ◽  
H. Lamprecht ◽  
M. Stander ◽  
...  
Keyword(s):  
Emergency Department ◽  
Randomized Controlled Trial ◽  
Length Of Stay ◽  
Diagnostic Accuracy ◽  
Standard Care ◽  
Primary Outcome ◽  
Point Of Care ◽  
Controlled Trial ◽  
Randomized Controlled ◽  
Secondary Outcomes

Introduction: Point of care ultrasound (PoCUS) is an established tool in the initial management of patients with undifferentiated hypotension in the emergency department (ED). While PoCUS protocols have been shown to improve early diagnostic accuracy, there is little published evidence for any mortality benefit. We report the findings from our international multicenter randomized controlled trial, assessing the impact of a PoCUS protocol on survival and key clinical outcomes. Methods: Recruitment occurred at 7 centres in North America (4) and South Africa (3). Scans were performed by PoCUS-trained physicians. Screening at triage identified patients (SBP<100 or shock index>1), randomized to PoCUS or control (standard care and no PoCUS) groups. Demographics, clinical details and study findings were collected prospectively. Initial and secondary diagnoses were recorded at 0 and 60 minutes, with ultrasound performed in the PoCUS group prior to secondary assessment. The primary outcome measure was 30-day/discharge mortality. Secondary outcome measures included diagnostic accuracy, changes in vital signs, acid-base status, and length of stay. Categorical data was analyzed using Fishers test, and continuous data by Student T test and multi-level log-regression testing. (GraphPad/SPSS) Final chart review was blinded to initial impressions and PoCUS findings. Results: 258 patients were enrolled with follow-up fully completed. Baseline comparisons confirmed effective randomization. There was no difference between groups for the primary outcome of mortality; PoCUS 32/129 (24.8%; 95% CI 14.3-35.3%) vs. Control 32/129 (24.8%; 95% CI 14.3-35.3%); RR 1.00 (95% CI 0.869 to 1.15; p=1.00). There were no differences in the secondary outcomes; ICU and total length of stay. Our sample size has a power of 0.80 (α:0.05) for a moderate effect size. Other secondary outcomes are reported separately. Conclusion: This is the first RCT to compare PoCUS to standard care for undifferentiated hypotensive ED patients. We did not find any mortality or length of stay benefits with the use of a PoCUS protocol, though a larger study is required to confirm these findings. While PoCUS may have diagnostic benefits, these may not translate into a survival benefit effect.

scholarly journals A randomized controlled trial on a self-guided Internet-based intervention for gambling problems

2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Lara Bücker ◽  
Josefine Gehlenborg ◽  
Steffen Moritz ◽  
Stefan Westermann
Keyword(s):  
Randomized Controlled Trial ◽  
Depressive Symptoms ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Group Differences ◽  
Control Group ◽  
Gambling Problems ◽  
Randomized Controlled ◽  
Secondary Outcomes ◽  
Internet Based Intervention

AbstractThe majority of individuals with problematic and pathological gambling remain untreated, and treatment barriers are high. Internet-based interventions can help to address existing barriers, and first studies suggest their potential for this target group. Within a randomized controlled trial (N = 150) with two assessment times (baseline and post-intervention), we aimed to investigate the feasibility, acceptance, and effectiveness of a self-guided Internet-based intervention targeted at gambling problems. We expected a significant reduction in gambling symptoms (primary outcome) and depressive symptoms as well gambling-specific dysfunctional thoughts (secondary outcomes) in the intervention group (IG) compared to a wait-list control group with access to treatment-as-usual (control group, CG) after the intervention period of 8 weeks. Results of the complete cases, per protocol, intention-to-treat (ITT), and frequent user analyses showed significant improvements in both groups for primary and secondary outcomes but no significant between-group differences (ITT primary outcome, F(1,147) = .11, p = .739, ηp2 < .001). Moderation analyses indicated that individuals in the IG with higher gambling and depressive symptoms, older age, and comorbid anxiety symptoms showed significant improvement relative to the CG. The intervention was positively evaluated (e.g., 96.5% rated the program as useful). Possible reasons for the nonsignificant between-group differences are discussed. Future studies should include follow-up assessments and larger samples to address limitations of the present study. Trial Registration ClinicalTrials.gov (NCT03372226), http://clinicaltrials.gov/ct2/show/NCT03372226, date of registration (13/12/2017).

scholarly journals An Internet-Based Cognitive Behavioral Therapy Program Adapted to Patients With Cardiovascular Disease and Depression: Randomized Controlled Trial

10.2196/14648 ◽  
2019 ◽  
Vol 6 (10) ◽  
pp. e14648 ◽  
Author(s):  
Peter Johansson ◽  
Mats Westas ◽  
Gerhard Andersson ◽  
Urban Alehagen ◽  
Anders Broström ◽  
...  
Keyword(s):  
Cardiovascular Disease ◽  
Randomized Controlled Trial ◽  
Cognitive Behavioral Therapy ◽  
Primary Outcome ◽  
Behavioral Therapy ◽  
Controlled Trial ◽  
Cognitive Behavioral ◽  
Randomized Controlled ◽  
Secondary Outcomes ◽  
Eq Vas

Background Depression is a common cause of reduced well-being and prognosis in patients with cardiovascular disease (CVD). However, there is a lack of effective intervention strategies targeting depression. Objective The study aimed to evaluate the effects of a nurse-delivered and adapted internet-based cognitive behavioral therapy (iCBT) program aimed at reducing depression in patients with CVD. Methods A randomized controlled trial was conducted. A total of 144 patients with CVD with at least mild depression (Patient Health Questionnaire–9 [PHQ-9] score ≥5) were randomized 1:1 to a 9-week program of iCBT (n=72) or an active control participating in a Web-based discussion forum (online discussion forum [ODF], n=72). The iCBT program, which included 7 modules, was adapted to fit patients with CVD. Nurses with an experience of CVD care provided feedback and a short introduction to cognitive behavioral therapy. The primary outcome, depression, was measured using PHQ-9. Secondary outcomes were depression measured using the Montgomery-Åsberg Depression Rating Scale–self-rating version (MADRS-S), health-related quality of life (HRQoL) measured using Short Form 12 (SF-12) survey and EuroQol Visual Analogue Scale (EQ-VAS), and the level of adherence. An intention-to-treat analysis with multiple imputations was used. Between-group differences in the primary and secondary outcomes were determined by the analysis of covariance, and a sensitivity analysis was performed using mixed models. Results Compared with ODF, iCBT had a significant and moderate treatment effect on the primary outcome depression (ie, PHQ-9; mean group difference=−2.34 [95% CI −3.58 to −1.10], P<.001, Cohen d=0.62). In the secondary outcomes, compared with ODF, iCBT had a significant and large effect on depression (ie, MADRS-S; P<.001, Cohen d=0.86) and a significant and moderate effect on the mental component scale of the SF-12 (P<.001, Cohen d=0.66) and the EQ-VAS (P<.001, Cohen d=0.62). Overall, 60% (n=43) of the iCBT group completed all 7 modules, whereas 82% (n=59) completed at least half of the modules. No patients were discontinued from the study owing to a high risk of suicide or deterioration in depression. Conclusions Nurse-delivered iCBT can reduce depression and improve HRQoL in patients with CVD, enabling treatment for depression in their own homes and at their preferred time. Trial Registration ClinicalTrials.gov NCT02778074; https://clinicaltrials.gov/ct2/show/NCT02778074

scholarly journals Efficacy of electro-acupuncture and manual acupuncture versus sham acupuncture for knee osteoarthritis: statistical analysis plan for a randomized controlled trial

2019 ◽  
Author(s):  
Jian-Feng Tu ◽  
Jing-Wen Yang ◽  
Li-Qiong Wang ◽  
Yang Wang ◽  
Jin-ling Li ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Statistical Analysis ◽  
Knee Osteoarthritis ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Statistical Analysis Plan ◽  
Sham Acupuncture ◽  
Manual Acupuncture ◽  
Randomized Controlled ◽  
Secondary Outcomes

Abstract Background: Acupuncture therapies are widely used for knee osteoarthritis (KOA), despite contradictory evidences. Current study is designed to determine the efficacy of electro-acupuncture and manual acupuncture versus sham acupuncture for KOA. Methods/design: Current study is a multi-center, three-arm, randomized controlled trial which will enroll 480 participants with KOA in China. Participants will be randomly assigned (1:1:1) to receive 24 sessions of electro-acupuncture, manual acupuncture, or sham acupuncture over 8 weeks. The primary outcome is the response rate - the proportion of patients who simultaneously achieve minimal clinically important improvement in pain and function domains at 8 weeks. The primary outcome will be analyzed using Z-test with intention-to-treat set. Secondary outcomes contain pain, function, global patient assessment and quality of life. Full details of the statistical analysis plan for the primary and secondary outcomes will be described in this article. The statistical analysis plan was written and submitted without knowledge of the study data. Discussion: The data will be analyzed according to this pre-specified statistical analysis plan to avoid data-driven analysis and enhance the transparency of current trial. The trial will provide high-quality evidence on the efficacy of acupuncture for KOA.

scholarly journals P122: Emergency department length of stay for alcohol intoxicated patients presenting with head injury

CJEM ◽  
2017 ◽  
Vol 19 (S1) ◽  
pp. S119
Author(s):  
C. Varner ◽  
S.L. McLeod ◽  
C. Thompson ◽  
B. Borgundvaag
Keyword(s):  
Emergency Department ◽  
Randomized Controlled Trial ◽  
Head Injury ◽  
Length Of Stay ◽  
Alcohol Intoxication ◽  
Controlled Trial ◽  
Care Hospital ◽  
Randomized Controlled ◽  
Ed Visits ◽  
Study Inclusion

Introduction: Excessive consumption of alcohol is associated with harm and responsible for up to 30% of emergency department (ED) visits. ED visits and length of stay (LOS) related to alcohol intoxication have increased over the last decade. The objective of this study was to compare the ED LOS of alcohol intoxicated and non-alcohol intoxicated patients presenting to the ED with acute head injury. Methods: This was a nested cohort analysis of patients screened for enrollment in a randomized controlled trial assessing minor traumatic brain injury (MTBI) discharge instructions in the ED of an academic tertiary care hospital (annual census 65,000). Patients aged 18 to 64 years presenting to the ED with a Canadian Emergency Department Information System (CEDIS) chief complaint of a head injury or suspected concussion occurring within 24 hours were eligible for study inclusion. Patients were identified as acutely intoxicated by their treating clinical providers. ED LOS for patients acutely intoxicated and those not intoxicated was compared using a Mann-Whitney U test using the Hodges-Lehmann method. Proportional differences were assessed using chi-square statistics. Results: A total of 164 patients were included in the analysis, 46 (28.0%) intoxicated and 118 (72.0%) not intoxicated. Median (IQR) ED LOS was 2.9 (1.5, 6.6) hours for intoxicated and 1.8 (1.3, 2.9) hours for non-intoxicated patients (Δ1.1 hours; 95% CI: 0.4, 1.8). Arrival by ambulance was higher in the intoxicated (73.9%) compared to the non-intoxicated (29.7%) group (Δ44.3%; 95% CI: 27.6, 57.1). Patients were more likely to have experienced assault in the intoxicated (34.8%) compared to the non-intoxicated (6.8%) group (Δ28.0%; 95% CI: 14.5, 42.8). There no difference in the proportion of patients who arrived after daytime hours, had a brain computed tomography, received analgesia in the ED, had another traumatic injury or had a history of psychiatric illness. Conclusion: One third of patients screened for a randomized controlled trial for MTBI were deemed ineligible for study inclusion due to acute alcohol intoxication. Alcohol intoxication was associated with prolonged ED LOS. Future studies specifically aimed at identifying factors that impact care on this frequent ED patient population are needed.

scholarly journals Impact of point-of-care ultrasound on the hospital length of stay for internal medicine inpatients with cardiopulmonary diagnosis at admission. – Study protocol of a randomized controlled trial: the IMFCU-1 (Internal Medicine Focused Clinical Ultrasound) study

2019 ◽  
Author(s):  
Ximena Anaite Cid ◽  
David Canty ◽  
Alistair Royse ◽  
Andrea Maier ◽  
Douglas Johnson ◽  
...  
Keyword(s):  
Internal Medicine ◽  
Randomized Controlled Trial ◽  
Length Of Stay ◽  
Patient Management ◽  
Point Of Care ◽  
Controlled Trial ◽  
Hospital Length ◽  
Hospital Length Of Stay ◽  
Point Of Care Ultrasound ◽  
Randomized Controlled

Abstract Background Point-of-care ultrasound (POCUS) is emerging as a reliable and valid clinical tool that impacts diagnosis and clinical decision making, and timely intervention for optimal patient management. This makes its utility in patients admitted to internal medicine wards attractive. However, there is still an evidence gap in all the medical setting of how its use affects clinical variables such as length of stay, morbidity and mortality. Methods/design A prospective randomized controlled trial assessing the effect of a surface POCUS of the heart, lungs, and femoral and popliteal veins performed by an internal medicine physician during the first 24 hours of patient admission to the unit with a presumptive cardiopulmonary diagnosis. The University of Melbourne iHeartScan, iLungScan and 2-point venous compression protocols are followed to identify left and right ventricular function, significant valvular heart disease, pericardial and pleural effusion, consolidation, pulmonary edema, pneumothorax and proximal deep venous thrombosis. Patient management is not commanded by the protocol and is at the discretion of the treating team. A total of 250 patients will be recruited at one tertiary hospital. Participants are randomized to receive POCUS or no POCUS. The primary outcome measured will be hospital length of stay. Secondary outcomes include the change in diagnosis and management, 30-day hospital readmission and health care costs. Discussion This study will evaluate the clinical impact of multi-organ POCUS in internal medicine patients admitted with cardiopulmonary diagnosis on the hospital length of stay. Recruitment of participants has commenced in September of 2018 and is estimated to be completed by March 2020.

scholarly journals Impact of point-of-care ultrasound on the hospital length of stay for internal medicine inpatients with cardiopulmonary diagnosis at admission: study protocol of a randomized controlled trial—the IMFCU-1 (Internal Medicine Focused Clinical Ultrasound) study

Trials ◽  
2020 ◽  
Vol 21 (1) ◽  
Author(s):  
Ximena Cid ◽  
David Canty ◽  
Alistair Royse ◽  
Andrea B. Maier ◽  
Douglas Johnson ◽  
...  
Keyword(s):  
Internal Medicine ◽  
Randomized Controlled Trial ◽  
Length Of Stay ◽  
Patient Management ◽  
Point Of Care ◽  
Controlled Trial ◽  
Hospital Length ◽  
Hospital Length Of Stay ◽  
Point Of Care Ultrasound ◽  
Randomized Controlled

Abstract Background Point-of-care ultrasound (POCUS) is emerging as a reliable and valid clinical tool that impacts diagnosis and clinical decision-making as well as timely intervention for optimal patient management. This makes its utility in patients admitted to internal medicine wards attractive. However, there is still an evidence gap in all the medical setting of how its use affects clinical variables such as length of stay, morbidity, and mortality. Methods/design A prospective randomized controlled trial assessing the effect of a surface POCUS of the heart, lungs, and femoral and popliteal veins performed by an internal medicine physician during the first 24 h of patient admission to the unit with a presumptive cardiopulmonary diagnosis. The University of Melbourne iHeartScan, iLungScan, and two-point venous compression protocols are followed to identify left and right ventricular function, significant valvular heart disease, pericardial and pleural effusion, consolidation, pulmonary edema, pneumothorax, and proximal deep venous thrombosis. Patient management is not commanded by the protocol and is at the discretion of the treating team. A total of 250 patients will be recruited at one tertiary hospital. Participants are randomized to receive POCUS or no POCUS. The primary outcome measured will be hospital length of stay. Secondary outcomes include the change in diagnosis and management, 30-day hospital readmission, and healthcare costs. Discussion This study will evaluate the clinical impact of multi-organ POCUS in internal medicine patients admitted with cardiopulmonary diagnosis on the hospital length of stay. Recruitment of participants commenced in September 2018 and is estimated to be completed by March 2020. Trial registration Australian and New Zealand Clinical Trial Registry, ACTRN12618001442291. Registered on 28 August 2018.

scholarly journals Efficacy of acupuncture based on acupoint combination theory for irritable bowel syndrome: study protocol for a multicenter randomized controlled trial

2021 ◽  
Author(s):  
Jing-wen Sun ◽  
Zhi-gang Li ◽  
Ming-liang Sun ◽  
Da Li ◽  
Jun Zhao ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Irritable Bowel Syndrome ◽  
Social Adjustment ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Randomized Controlled ◽  
Self Rating ◽  
Multicenter Randomized Controlled Trial ◽  
Secondary Outcomes ◽  
Irritable Bowel

Abstract Background: Irritable bowel syndrome (IBS) is a chronic gastrointestinal disorder characterized by abdominal pain, diarrhea or constipation, and changes in defecation patterns. No organic disease has been found to explain these symptoms by routine clinical examination. This study aims to investigate the efficacy and safety of acupuncture therapy for IBS patients based on conventional treatments. We also want to explore the optimal acupoint combination recommended for IBS and clarify the clinical advantage of "multi-acupoint co-effect and synergistic effect".Methods and analysis: A total of 204 eligible patients who meet the Rome IV criteria for IBS will be randomly allocated to receive different acupuncture. Each patient will receive 12 acupuncture treatments over four weeks and will be followed up for four weeks. The primary outcome is the IBS-symptom severity score (IBS-SSS). The secondary outcomes include the Bristol stool form scale(BSFS), the work and social adjustment score (WSAS), the IBS-quality of life (IBS-QOL), self-rating anxiety scale (SAS), and the self-rating depression scale (SDS). Both the primary outcome and the secondary outcomes measures are collected at baseline, 2 weeks, and 4 weeks of the intervention, 6 weeks, and 8 weeks after the intervention.Ethics and dissemination: The entire project has been approved by the ethics committee of Beijing University of Chinese Medicine ( 2020BZYLL0903 ) .Discussion: This is a multicenter randomized controlled trial for IBS in China. This may shed light on the efficacy of acupuncture as an alternative to IBS. The results of the trial will be disseminated in peer-reviewed publications. Trial registration: Chinese Clinical Trials Register, ID: ChiCTR2000041215.First registered on 12 December 2020. http://www.chictr.org.cn/.

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