Detection of Fetal Anomalies by Remotely Directed and Interpreted Ultrasound (Teleultrasound): A Randomized Noninferiority Trial

2021 ◽  
Author(s):  
Julie R. Whittington ◽  
Dawn S. Hughes ◽  
Nader Z. Rabie ◽  
Songthip T. Ounpraseuth ◽  
Wendy N. Nembhard ◽  
...  
Keyword(s):  
Patient Satisfaction ◽  
Predictive Value ◽  
Primary Outcome ◽  
Rate Sensitivity ◽  
Control Group ◽  
Fetal Anomalies ◽  
Maternal Fetal Medicine ◽  
Maternal Characteristics ◽  
Key Points ◽  
Ultrasound Group

Objective To determine the accuracy and reliability of remotely directed and interpreted ultrasound (teleultrasound) as compared with standard in-person ultrasound for the detection of fetal anomalies, and to determine participants' satisfaction with teleultrasound. Study Design This was a single-center, randomized (1:1) noninferiority study. Individuals referred to the maternal–fetal medicine (MFM) ultrasound clinic were randomized to standard in-person ultrasound and counseling or teleultrasound and telemedicine counseling. The primary outcome was major fetal anomaly detection rate (sensitivity). All ultrasounds were performed by registered diagnostic medical sonographers and interpretations were done by a group of five MFM physicians. After teleultrasound was completed, the teleultrasound patients filled out a satisfaction survey using a Likert scale. Newborn data were obtained from the newborn record and statewide birth defect databases. Results Of 300 individuals randomized in each group, 294 were analyzed in the remotely interpreted teleultrasound group and 291 were analyzed in the in-person ultrasound group. The sensitivity of sonographic detection of 28 anomalies was 82.14% in the control group and of 20 anomalies in the telemedicine group, it was 85.0%. The observed difference in sensitivity was 0.0286, much smaller than the proposed noninferiority limit of 0.05. Specificity, negative predictive value, positive predictive value, and accuracy were more than 94% for both groups. Patient satisfaction was more than 95% on all measures, and there were no significant differences in patient satisfaction based on maternal characteristics. Conclusion Teleultrasound is not inferior to standard in-person ultrasound for the detection of fetal anomalies. Teleultrasound was uniformly well received by patients, regardless of demographics. These key findings support the continued expansion of telemedicine services. Key Points

scholarly journals Effect of Ketorolac on the Prevention of Postoperative Catheter-Related Bladder Discomfort in Patients Undergoing Robot-Assisted Laparoscopic Radical Prostatectomy: A Randomized, Double-Blinded, Placebo-Controlled Study

2019 ◽  
Vol 8 (6) ◽  
pp. 759
Author(s):  
Jun-Young Park ◽  
Jun Hyuk Hong ◽  
Jihion Yu ◽  
Doo-Hwan Kim ◽  
Gi-Ho Koh ◽  
...  
Keyword(s):  
Patient Satisfaction ◽  
Radical Prostatectomy ◽  
Primary Outcome ◽  
Laparoscopic Radical Prostatectomy ◽  
Controlled Study ◽  
Control Group ◽  
Robot Assisted ◽  
Pain Scores ◽  
Patient Satisfaction Scores ◽  
Double Blinded

Urinary catheterization can cause catheter-related bladder discomfort (CRBD). Ketorolac is widely used for pain control. Therefore, we evaluated the effect of ketorolac on the prevention of CRBD in patients undergoing robot-assisted laparoscopic radical prostatectomy (RALP). All patients were randomly allocated to the ketorolac group or the control group. The primary outcome was CRBD above a moderate grade at 0 h postoperatively. CRBD above a moderate grade at 1, 2, and 6 h was also assessed. Postoperative pain, opioid requirement, ketorolac-related complications, patient satisfaction, and hospitalization duration were also assessed. The incidence of CRBD above a moderate grade at 0 h postoperatively was significantly lower in the ketorolac group (21.5% vs. 50.8%, p = 0.001) as were those at 1, 2, and 6 h. Pain scores at 0 and 1 h and opioid requirement over 24 h were significantly lower in the ketorolac group, while patient satisfaction scores were significantly higher in the ketorolac group. Ketorolac-related complications and hospitalization duration were not significantly different between the two groups. This study shows ketorolac can reduce postoperative CRBD above a moderate grade and increase patient satisfaction in patients undergoing RALP, suggesting it is a useful option to prevent postoperative CRBD.

Videoconferencing in a mental health service in The Netherlands: A randomized controlled trial on patient satisfaction and clinical outcomes for outpatients with severe mental illness

2016 ◽  
Vol 23 (5) ◽  
pp. 513-520 ◽  
Author(s):  
Alexander M Hulsbosch ◽  
M Annet Nugter ◽  
Petra Tamis ◽  
Hans Kroon
Keyword(s):  
Mental Illness ◽  
Patient Satisfaction ◽  
Severe Mental Illness ◽  
Effect Size ◽  
Statistical Power ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Added Value ◽  
Control Group ◽  
Degree Of Satisfaction

Introduction The goal of the study was to determinate if there was added value in the use of videoconferencing (VCF) in outpatient care for people with severe mental illness (SMI). Methods A VCF-group was compared to a control group (care as usual) over a period of 18 months. Block randomization was used to assign patients to one of the two groups. The video communication was available to the patients on a 24/7 basis, so that emergency calls could also be made via VCF. The primary outcome was patient satisfaction, other outcomes were: quality of life, loneliness, daily functioning (psychologically and socially), and the fulfilment of needs of care. Eventually, 93 patients signed their informed consent and participated. Results For the primary outcome a statistically significant time by treatment interaction effect was found, where higher degree of satisfaction was associated with the patients in the VCF-group. The secondary outcomes revealed no differences between the two groups. Despite the participants not using the VCF units extensively during the project, they were reasonably satisfied with VCF; on average, they rated the service with a 7.5 grade (on a scale from 1–10). Discussion Although the study showed a positive result for patient satisfaction, overall the VCF seemed to have limited impact. So VCF might not offer much added value to care as usual. However, statistical power in this study dropped somewhat due to dropout. Furthermore, VCF usage was lower than expected. Assuming that VCF will be most effective if it is actually used, it seems likely that the actual effect-size reached in this study has been significantly lower than the anticipated effect-size. Finally, this study shows that VCF is a tool that can be used in the care for people with severe mental illness.

Screening for haemorrhagic disorders in paediatric patients by means of a questionnaire

2009 ◽  
Vol 29 (S 01) ◽  
pp. S87-S89 ◽  
Author(s):  
I. Music ◽  
M. Novak ◽  
B. Acham-Roschitz ◽  
W. Muntean
Keyword(s):  
Predictive Value ◽  
Laboratory Diagnosis ◽  
Von Willebrand Disease ◽  
Control Group ◽  
Older Children ◽  
Mild Disease ◽  
History Of ◽  
Von Willebrand ◽  
Specific Symptoms ◽  
Infants And Young Children

SummaryAim: In children, screening for haemorrhagic disorders is further complicated by the fact that infants and young children with mild disease in many cases most likely will not have a significant history of easy bruising or bleeding making the efficacy of a questionnaire even more questionable. Patients, methods: We compared the questionnaires of a group of 88 children in whom a haemorrhagic disorder was ruled out by rigorous laboratory investigation to a group of 38 children with mild von Willebrand disease (VWD). Questionnaires about child, mother and father were obtained prior to the laboratory diagnosis on the occasion of routine preoperative screening. Results: 23/38 children with mild VWD showed at least one positive question in the questionnaire, while 21/88 without laboratory signs showed at least one positive question. There was a trend to more specific symptoms in older children. Three or more positive questions were found only in VWD patients, but only in a few of the control group. The question about menstrual bleeding in mothers did not differ significantly. Sensitivity of the questionnaire for a hemostatic disorder was 0.60, while specifity was 0.76. The negative predictive value was 0.82, but the positive predictive value was only 0.52. Conclusions: Our small study shows, that a questionnaire yields good results to exclude a haemostatic disorder, but is not a sensitive tool to identify such a disorder.

Comparative study of intracranial access in thrombectomy using next generation 0.088 inch guide catheter technology

2021 ◽  
pp. neurintsurg-2021-017341
Author(s):  
Devin V Bageac ◽  
Blake S Gershon ◽  
Jan Vargas ◽  
Maxim Mokin ◽  
Zeguang Ren ◽  
...  
Keyword(s):  
Primary Outcome ◽  
Primary Outcome Measure ◽  
Secondary Outcome ◽  
Control Group ◽  
Anterior Circulation ◽  
Guide Catheter ◽  
Catheter Failure ◽  
Catheter Technology ◽  
Intracranial Vasculature

BackgroundMost conventional 0.088 inch guide catheters cannot safely navigate intracranial vasculature. The objective of this study is to evaluate the safety of stroke thrombectomy using a novel 0.088 inch guide catheter designed for intracranial navigation.MethodsThis is a multicenter retrospective study, which included patients over 18 years old who underwent thrombectomy for anterior circulation large vessel occlusions. Technical outcomes for patients treated using the TracStar Large Distal Platform (TracStar LDP) or earlier generation TRX LDP were compared with a matched cohort of patients treated with other commonly used guide catheters. The primary outcome measure was device-related complications. Secondary outcome measures included guide catheter failure and time between groin puncture and clot engagement.ResultsEach study arm included 45 patients. The TracStar group was non-inferior to the control group with regard to device-related complications (6.8% vs 8.9%), and the average time to clot engagement was 8.89 min shorter (14.29 vs 23.18 min; p=0.0017). There were no statistically significant differences with regard to other technical outcomes, including time to recanalization (modified Thrombolysis In Cerebral Infarction (mTICI) ≥2B). The TracStar was successfully advanced into the intracranial internal carotid artery in 33 cases (73.33%); in three cases (6.67%), it was swapped for an alternate catheter. Successful reperfusion (mTICI 2B-3) was achieved in 95.56% of cases. Ninety-day follow-up data were available for 86.67% of patients, among whom 46.15% had an modified Rankin Score of 0–2%, and 10.26% were deceased.ConclusionsTracstar LDP is safe for use during stroke thrombectomy and was associated with decreased time to clot engagement. Intracranial access was regularly achieved.

scholarly journals The Predictive Value of the Mother’s Risk Factors in Formation of Fetal Developmental Delay

2021 ◽  
Vol 8 ◽  
pp. 2333794X2199914
Author(s):  
Maka Chigladze
Keyword(s):  
Risk Factors ◽  
Pregnant Women ◽  
Predictive Value ◽  
Negative Impact ◽  
Deficiency Anemia ◽  
Control Group ◽  
Case Group ◽  
Retrospective Case ◽  
Standards Of Living ◽  
Poor Nutrition

The research aimed at studying the mother’s social-hygienic and medical biological risk factors and determining their predictive value. The retrospective case-control study was conducted with 142 pregnant women participating in it. In the case group there were involved 92 mothers whose pregnancy was completed by the birth of a newborn baby suffering from the intrauterine growth restriction. The control group was made of 50 pregnant women, whose pregnancy was completed by the birth of a healthy neonate. The research resulted in specifying the risk factors of high priority: the low standards of living (OR 3.61), chronic stress (OR-3.06), sleeping disorder (OR-3.33) and poor nutrition (OR-3.81). As regards the coexisting pathology the following was revealed: endocrine pathology (OR-3.27), ischemic heart disease (OR-4.35), arterial hypertension (OR-6.47), iron deficiency anemia (OR-4.11), pathology of respiratory system (OR-3.42), chronic genital inflammatory and infectious processes. The preeclampsia (92%) and low amniotic fluid (89%) were detected to have the high predictive value. The awareness of risk factors allows us to employ the timely measures for the reduction of negative impact on the fetus and neonate.

scholarly journals Circulating tumour DNA methylation in hepatocellular carcinoma diagnosis using digital droplet PCR

2021 ◽  
Vol 49 (3) ◽  
pp. 030006052199296
Author(s):  
Juan Wang ◽  
Liu Yang ◽  
Yanjun Diao ◽  
Jiayun Liu ◽  
Jinjie Li ◽  
...  
Keyword(s):  
Hepatocellular Carcinoma ◽  
Dna Methylation ◽  
Likelihood Ratio ◽  
Predictive Value ◽  
Positive Likelihood Ratio ◽  
Negative Likelihood Ratio ◽  
Control Group ◽  
Control Subjects ◽  
Droplet Pcr ◽  
Healthy Control

Objective To evaluate the performance of a DNA methylation-based digital droplet polymerase chain reaction (ddPCR) assay to detect aberrant DNA methylation in cell-free DNA (cfDNA) and to determine its application in the detection of hepatocellular carcinoma (HCC). Methods The present study recruited patients with liver-related diseases and healthy control subjects. Blood samples were used for the extraction of cfDNA, which was then bisulfite converted and the extent of DNA methylation quantified using a ddPCR platform. Results A total of 97 patients with HCC, 80 healthy control subjects and 46 patients with chronic hepatitis B/C virus infection were enrolled in the study. The level of cfDNA in the HCC group was significantly higher than that in the healthy control group. For the detection of HCC, based on a cut-off value of 15.7% for the cfDNA methylation ratio, the sensitivity and specificity were 78.57% and 89.38%, respectively. The diagnostic accuracy was 85.27%, the positive predictive value was 81.91% and the negative predictive value was 87.20%. The positive likelihood ratio of 15.7% in HCC diagnosis was 7.40, while the negative likelihood ratio was 0.24. Conclusions A sensitive methylation-based assay might serve as a liquid biopsy test for diagnosing HCC.

scholarly journals Healthy eating and lifestyle in pregnancy (HELP): a cluster randomised trial to evaluate the effectiveness of a weight management intervention for pregnant women with obesity on weight at 12 months postpartum

2021 ◽  
Author(s):  
Sharon A. Simpson ◽  
Elinor Coulman ◽  
Dunla Gallagher ◽  
Karen Jewell ◽  
David Cohen ◽  
...  
Keyword(s):  
Weight Management ◽  
Healthy Eating ◽  
Primary Outcome ◽  
Intervention Group ◽  
Control Group ◽  
Risky Drinking ◽  
Management Intervention ◽  
Cluster Randomised ◽  
Secondary Outcomes ◽  
Weight Management Intervention

Abstract Objective To assess whether a weight management intervention for pregnant women with obesity was effective in reducing body mass index (BMI) 12 months after giving birth. Methods Pragmatic, cluster randomised controlled trial (RCT) with embedded cost-effectiveness analysis. 598 women with a BMI of ≥30 kg/m2 (between 12 and 20 weeks gestation) were recruited from 20 secondary care maternity units in England and Wales. BMI at 12 months postpartum was the primary outcome. A range of clinical and behavioural secondary outcomes were examined. Interventions Women attending maternity units randomised to intervention were invited to a weekly weight management group, which combined expertise from a commercial weight loss programme with clinical advice from midwives. Both intervention and control participants received usual care and leaflets on diet and physical activity in pregnancy. Results Mean (SD) BMI at 12 months postpartum was 36.0 kg/m2 (5.2) in the control group, and 37.5 kg/m2 (6.7) in the intervention group. After adjustment for baseline BMI, the intervention effect was −0.02 (95% CI −0.04 to 0.01). The intervention group had an improved healthy eating score (3.08, 95% CI 0.16 to 6.00, p < 0.04), improved fibre score (3.22, 1.07 to 5.37, p < 0.01) and lower levels of risky drinking at 12 months postpartum compared to the control group (OR 0.45, 0.27 to 0.74, p < 0.002). The net incremental monetary benefit was not statistically significantly different between arms, although the probability of the intervention being cost-effective was above 60%, at policy-relevant thresholds. Conclusions There was no significant difference between groups on the primary outcome of BMI at 12 months. Analyses of secondary outcomes indicated improved healthy eating and lower levels of risky drinking. Trial registration: Current Controlled Trials ISRCTN25260464.

scholarly journals A113 ANNUAL COLONOSCOPY VOLUME IS NOT PREDICTIVE OF COLONOSCOPY QUALITY - FINDINGS FROM THE SOUTHWEST ONTARIO COLONOSCOPY COHORT

2021 ◽  
Vol 4 (Supplement_1) ◽  
pp. 92-93
Author(s):  
M Sey ◽  
O Siddiqi ◽  
C McDonald ◽  
S cocco ◽  
Z Hindi ◽  
...  
Keyword(s):  
Predictive Value ◽  
Detection Rate ◽  
Primary Outcome ◽  
Case Mix ◽  
Operating Characteristics ◽  
Polyp Detection ◽  
Cecal Intubation ◽  
Polyp Detection Rate ◽  
Secondary Outcomes ◽  
Colonoscopy Quality

Abstract Background Performing a minimum number of colonoscopies annually has been proposed by some jurisdictions as a requirement for maintaining privileges. However, this practice is supported by limited evidence. Aims The objective of this study was to determine if annual colonoscopy volume was associated with colonoscopy quality metrics. Methods A population-based study was performed using the Southwest Ontario Colonoscopy cohort, which consists of all adult patients who underwent colonoscopy between April 2017 and Oct 2018 at 21 academic and community hospitals within the health region. Data were collected through a mandatory quality assurance form completed after each procedure and pathology reports were manually reviewed. Physician annualized colonoscopy volumes were compared by correlation analysis to each quality-related outcome, by means of the area under the receiver operating characteristics curve (AUROC), and logistic regression. The prognostic value of colonoscopy volume was also adjusted for case-mix and potential confounders in separate regression analyses for each outcome. The primary outcome was ADR. Secondary outcomes were polyp detection rate (PDR), sessile serrated polyp detection rate (SSPDR), and cecal intubation. Results A total of 47,195 colonoscopies were performed by 75 physicians (37.5% by gastroenterologists, 60% by general surgeons, 2.5% others). There were no clear relationships between annual colonoscopy volumes and study outcomes. Colonoscopy volume was not associated with ADR (OR 1.03, 95% CI 0.96–1.10, p=0.48) and corresponded to an AUROC not significantly different from the null (AUROC 0.52, 95% CI 0.43–0.61, p=0.65). Multi-variable regression adjusting for case-mix also demonstrated no predictive value of annual colonoscopy volume for the primary outcome (OR 1.03, 95% CI 0.94–1.12, p=0.55). Similarly, analyses of secondary outcomes failed to find an association between colonoscopy volume and PDR, SSPDR, or cecal intubation (Table 1). Conclusions Annual colonoscopy volumes do not predict ADR, PDR, SSPDR, or cecal intubation rate. Results of unconditional and conditional approaches for examining the predictive value of annual colonoscopy volume for quality related outcomes. Funding Agencies None

scholarly journals Effects of different thermal insulation methods on the nasopharyngeal temperature in patients undergoing laparoscopic hysterectomy: a prospective randomized controlled trial

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Guanyu Yang ◽  
Zefei Zhu ◽  
Hongyu Zheng ◽  
Shifeng He ◽  
Wanyue Zhang ◽  
...  
Keyword(s):  
Thermal Insulation ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Laparoscopic Hysterectomy ◽  
Control Group ◽  
Prospective Randomized Controlled Trial ◽  
Warming Blanket ◽  
Group A ◽  
Insulation Effect ◽  
Group B

Abstract Background This study explored the comparison of the thermal insulation effect of incubator to infusion thermometer in laparoscopic hysterectomy. Methods We assigned 75 patients enrolled in the study randomly to three groups: Group A: Used warming blanket; group B: Used warming blanket and infusion thermometer; group C: Used warming blanket and incubator. The nasopharyngeal temperature at different time points during the operation served as the primary outcome. Results The nasopharyngeal temperature of the infusion heating group was significantly higher than that of the incubator group 60 min from the beginning of surgery (T3): 36.10 ± 0.20 vs 35.81 ± 0.20 (P<0.001)90 min from the beginning of surgery (T4): 36.35 ± 0.20 vs 35.85 ± 0.17 (P<0.001). Besides, the nasopharyngeal temperature of the incubator group was significantly higher compared to that of the control group 60 min from the beginning of surgery (T3): 35.81 ± 0.20 vs 35.62 ± 0.18 (P<0.001); 90 min from the beginning of surgery (T4): 35.85 ± 0.17 vs 35.60 ± 0.17 (P<0.001). Regarding the wake-up time, that of the control group was significantly higher compared to the infusion heating group: 24 ± 4 vs 21 ± 4 (P = 0.004) and the incubator group: 24 ± 4 vs 22 ± 4 (P = 0.035). Conclusion Warming blanket (38 °C) combined infusion thermometer (37 °C) provides better perioperative thermal insulation. Hospitals without an infusion thermometer can opt for an incubator as a substitute. Trial registration This trial was registered with ChiCTR2000039162, 20 October 2020.

scholarly journals 141. Implementation of Veterans Affairs Outpatient Antimicrobial Stewardship Interventions for Asymptomatic Bacteriuria and Acute Respiratory Infections, a Stepped Wedge Randomized Study

2020 ◽  
Vol 7 (Supplement_1) ◽  
pp. S81-S82
Author(s):  
Grace Mortrude ◽  
Mary Rehs ◽  
Katherine Sherman ◽  
Nathan Gundacker ◽  
Claire Dysart
Keyword(s):  
Patient Satisfaction ◽  
Primary Outcome ◽  
Respiratory Infections ◽  
Asymptomatic Bacteriuria ◽  
Educational Interventions ◽  
Antibiotic Prescribing ◽  
Acute Respiratory Infections ◽  
Stepped Wedge ◽  
Post Intervention ◽  
The Impact

Abstract Background Outpatient antimicrobial prescribing is an important target for antimicrobial stewardship (AMS) interventions to decrease antimicrobial resistance in the United States. The objective of this study was to design, implement and evaluate the impact of AMS interventions focused on asymptomatic bacteriuria (ASB) and acute respiratory infections (ARIs) in the outpatient setting. Methods This randomized, stepped-wedge trial evaluated the impact of educational interventions to providers on adult patients presenting to primary care (PC) clinics for ARIs and ASB from 10/1/19 to 1/31/20. Data was collected by retrospective chart review. An antibiotic prescribing report card was provided to PC providers, then an educational session was delivered at each PC clinic. Patient education materials were distributed to PC clinics. Interventions were made in a step-wise (figure 1) fashion. The primary outcome was percentage of overall antibiotic prescriptions as a composite of prescriptions for ASB, acute bronchitis, upper-respiratory infection otherwise unspecified, uncomplicated sinusitis, and uncomplicated pharyngitis. Secondary outcomes included individual components of the primary outcome, a composite safety endpoint of related hospital, emergency department or primary care visit within 4 weeks, antibiotic appropriateness, and patient satisfaction surveys. Figure 1 Results There were 887 patients included for analysis (405 pre-intervention, 482 post-intervention). Baseline characteristics are summarized in table 1. After controlling for type 1 error using a Bonferroni correction the primary outcome was not significantly different between groups (56% vs 49%). There was a statistically significant decrease in prescriptions for bronchitis (20.99% vs 12.66%; p=0.0003). Appropriateness of prescriptions for sinusitis (OR 4.96; CI 1.79–13.75; p=0.0021) and pharyngitis (OR 5.36; CI 1.93 – 14.90; p=0.0013) was improved in the post-intervention group. The composite safety outcome and patient satisfaction survey ratings did not differ between groups. Table 1 Conclusion Multifaceted educational interventions targeting providers can improve antibiotic prescribing for indications rarely requiring antimicrobials without increasing re-visit or patient satisfaction surveys. Disclosures All Authors: No reported disclosures

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