scholarly journals The Utility of Real-Time Remote Auscultation Using an Internet-Connected Electronic Stethoscope: An Open-Label Randomized Controlled Pilot Trial

2021 ◽  
Author(s):  
Takahiro Ito ◽  
Takanobu Hirosawa ◽  
Yukinori Harada ◽  
Kohei Ikenoya ◽  
Shintaro Kakimoto ◽  
...  
Keyword(s):  
Real Time ◽  
Intervention Group ◽  
Control Group ◽  
Cardiac Auscultation ◽  
Open Label ◽  
Electronic Stethoscope ◽  
Randomized Controlled ◽  
Valvular Diseases ◽  
Lung Auscultation ◽  
Total Test

Abstract Objective: This study aimed to assess the utility of real-time remote auscultation using the cardiopulmonary simulators.Methods: In this open-label, randomized controlled trial, the researchers randomly assigned general internal medicine doctors to the real-time remote auscultation group (intervention group) or the classical auscultation group (control group). In the training session, participants listened to five different lung sounds and five cardiac sounds in a previously determined order with the correct classification. In the test session, participants had to classify the five lung sounds and five cardiac sounds in random order. For both sessions, the intervention group auscultated at a distance of 220 m, with an Internet-connected electronic stethoscope while watching the auscultation places on the computer screen. The control group performed direct auscultation using a classical stethoscope. The primary outcome was the total test score.Results: Twenty participants were included in the study. The total test scores of lung auscultation in the intervention (86%) and control (90%) groups were not significantly different (P = .54). The total test score of cardiac auscultation in the control group (94%) was superior to that in the intervention group (72%, P < .05). Valvular diseases were not misclassified as normal sounds in real-time remote cardiac auscultation. Discussion and Conclusions: The utility of real-time remote lung auscultation using an Internet-connected electronic stethoscope was comparable to that of classical lung auscultation. Classical cardiac auscultation was superior to real-time remote cardiac auscultation. However, real-time remote cardiac auscultation is useful for classifying valvular diseases and normal sounds. Trial Registration: UMIN-CTR UMIN000043153; https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000049259 The date of first registration:28/01/2021

The Utility of Real-Time Remote Cardiac Auscultation Using a Bluetooth-Connected Electronic Stethoscope: Open-Label Randomized Controlled Pilot Trial (Preprint)

2020 ◽  
Author(s):  
Takanobu Hirosawa ◽  
Yukinori Harada ◽  
Kohei Ikenoya ◽  
Shintaro Kakimoto ◽  
Taro Shimizu
Keyword(s):  
Real Time ◽  
Heart Sound ◽  
Intervention Group ◽  
Heart Sounds ◽  
Control Group ◽  
Cardiac Auscultation ◽  
Open Label ◽  
Patient Simulator ◽  
Electronic Stethoscope ◽  
Randomized Controlled

BACKGROUND With the coronavirus disease 2019 pandemic, the need for telemedicine is rapidly growing worldwide. The development and improvement of remote physical examination systems, especially remote auscultation, are required to facilitate telemedicine. A Bluetooth system combined with an electronic stethoscope is a promising option for remote auscultation in clinics and hospitals. In our previous work, we demonstrated that the utility of a Bluetooth-connected real-time remote auscultation system for the lung simulator is comparable to that of classical direct auscultation. However, the utility of such systems remains unknown for cardiac auscultation. OBJECTIVE This study was conducted to evaluate the utility of real-time auscultation using a Bluetooth-connected electronic stethoscope compared to that of classical auscultation using a cardiology patient simulator. METHODS This was an open-label randomized controlled trial, including senior residents and faculty members in the Department of General Internal Medicine of a university hospital. The only exclusion criterion was a refusal to participate. All participants attended a tutorial session, in which they listened to 15 heart sounds on the cardiology patient simulator using a traditional stethoscope and were told the correct classification. Thereafter, participants were randomly assigned to either the real-time remote auscultation group (intervention group) or the classical auscultation group (control group) for test sessions. In the test sessions, participants had to classify a series of ten heart sounds. The intervention group remotely listened to the heart sounds using an electronic stethoscope, a Bluetooth transmitter, and a wireless, noise-canceling, stereo headset. The control group listened to the heart sounds directly using a classic stethoscope. The primary outcome was the test score. The secondary outcomes were the rates of correct answers for each heart sound. The two groups were compared using Fisher’s exact test. RESULTS In total, 20 participants were included; six and 14 were assigned to the intervention and control groups, respectively. There was no difference in age (P=.99), sex (P=.99), or years from graduation (P=.78) between the two groups. The overall test score in the intervention group (50/60, 83.3%) was not different from that in the control group (119/140, 85.0%) (P=.77). There was no heart sound for which the correct answer rate differed between groups. CONCLUSIONS This study demonstrated that the utility of a real-time remote cardiac auscultation system using a Bluetooth-connected electronic stethoscope was comparable to that of direct auscultation using a classic stethoscope. This implies that the real world’s essential heart sounds could be classified by a real-time remote cardiac auscultation system using a Bluetooth-connected electronic stethoscope. CLINICALTRIAL UMIN-CTR UMIN000041601; https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000047136

scholarly journals The Utility of Real-Time Remote Lung Auscultation Using a Bluetooth-Connected Electronic Stethoscope: Open-Label Randomized Controlled Pilot Trial (Preprint)

2020 ◽  
Author(s):  
Takanobu Hirosawa ◽  
Yukinori Harada ◽  
Kohei Ikenoya ◽  
Shintaro Kakimoto ◽  
Yuki Aizawa ◽  
...  
Keyword(s):  
Real Time ◽  
Test Score ◽  
Intervention Group ◽  
Control Group ◽  
Lung Sounds ◽  
Lung Sound ◽  
Open Label ◽  
Electronic Stethoscope ◽  
Randomized Controlled ◽  
Lung Simulator

BACKGROUND The urgent need for telemedicine has become clear situation in the pandemic of the coronavirus disease 2019. To facilitate telemedicine, the development and improvement of remote examination systems are required. A system combining an electronic stethoscope and Bluetooth connectivity is a promising option for remote auscultation in clinics and hospitals. However, the utility of such systems remains unknown. OBJECTIVE This study was conducted to assess the utility of real-time auscultation, using a Bluetooth-connected electronic stethoscope compared to that of classical auscultation, using a lung simulator. METHODS This was an open-label randomized controlled trial, including senior residents and faculty in the department of general internal medicine of a university hospital. The only exclusion criterion was a refusal to participate. All participants attended a tutorial session, in which they listened to 15 lung sounds on the lung simulator using a classic stethoscope and were told the correct classification. Thereafter, participants were randomly assigned to either the real-time remote auscultation group (intervention group) or the classical auscultation group (control group), for test sessions. In the test sessions, participants had to classify a series of ten lung sounds. The intervention group listened to the lung sounds remotely, using the electronic stethoscope, a Bluetooth transmitter, and a wireless, noise-canceling, stereo headset. The control group listened to the lung sounds directly using a traditional stethoscope. The primary outcome was the test score, and the secondary outcomes were the rates of correct answers for each lung sound. The two groups were compared using the Fisher exact test. RESULTS In total, 20 participants were included; eleven and nine were assigned to the intervention and control groups, respectively. There was no difference in age (P=.25), sex (P=.82), and years from graduation (P=.15) between the two groups. The overall test score in the intervention group (80/110, 72.7%) was not different from that in the control group (71/90, 78.9%) (P=.32). The only lung sound for which the correct answer rate differed between groups was that of pleural friction rubs (P=.03); it was lower in the intervention group (3/11, 27%) than in the control group (7/9, 78%,). CONCLUSIONS The utility of a real-time remote auscultation system using a Bluetooth-connected electronic stethoscope was comparable to that of direct auscultation using a classic stethoscope, except for classification of pleural friction rubs. CLINICALTRIAL UMIN-CTR UMIN000040828; https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046222.

Investigating the Impact of Cognitive Training for Individuals With Bothersome Tinnitus: A Randomized Controlled Trial

2021 ◽  
pp. 019459982199474
Author(s):  
Maggie Xing ◽  
Dorina Kallogjeri ◽  
Jay F. Piccirillo
Keyword(s):  
Randomized Controlled Trial ◽  
Cognitive Training ◽  
Mixed Model ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Functional Index ◽  
Open Label ◽  
Randomized Controlled ◽  
The Impact

Objective To evaluate the effectiveness of cognitive training in improving tinnitus bother and to identify predictors of patient response. Study Design Prospective open-label randomized controlled trial. Setting Online. Methods Participants were adults with subjective idiopathic nonpulsatile tinnitus causing significant tinnitus-related distress. The intervention group trained by using auditory-intensive exercises for 20 minutes per day, 5 days per week, for 8 weeks. The active control group trained on the same schedule with non–auditory intensive games. Surveys were completed at baseline, 8 weeks, and 12 weeks. Results A total of 64 participants completed the study. The median age was 63 years (range, 25-69) in the intervention group and 61 years (34-68) in the control group. Mixed model analysis revealed that within-subject change in Tinnitus Functional Index in the intervention group was not different than the control group, with marginal mean differences (95% CI): 0.24 (–11.20 to 10.7) and 2.17 (–8.50 to 12.83) at 8 weeks and 2.33 (–8.6 to 13.3) and 3.36 (–7.91 to 14.6) at 12 weeks, respectively. When the 2 study groups were compared, the control group had higher Tinnitus Functional Index scores than the intervention group by 10.5 points at baseline (95% CI, –0.92 to 29.89), 8.1 at 8 weeks (95% CI, –3.27 to 19.42), and 9.4 at 12 weeks (95% CI, –2.45 to 21.34). Conclusion Auditory-intensive cognitive training was not associated with changes in self-reported tinnitus bother. Given the potential for neuroplasticity to affect tinnitus, we believe that future studies on cognitive training for tinnitus remain relevant.

Validation of an Instrument for Real-Time Assessment of Neonatal Intubation Skills: A Randomized Controlled Simulation Study

2020 ◽  
Author(s):  
Lindie J.M.K. Kuijpers ◽  
Mathijs Binkhorst ◽  
Nicole K. Yamada ◽  
Romy N. Bouwmeester ◽  
Arno F.J. van Heijst ◽  
...  
Keyword(s):  
Construct Validity ◽  
Real Time ◽  
Simulation Study ◽  
Intraclass Correlation ◽  
Intervention Group ◽  
Control Group ◽  
Validity And Reliability ◽  
Patient Simulator ◽  
Randomized Controlled ◽  
Time Assessment

Objective This study aimed to evaluate the construct validity and reliability of real-time assessment of a previously developed neonatal intubation scoring instrument (NISI). Study Design We performed a randomized controlled simulation study at a simulation-based research and training facility. Twenty-four clinicians experienced in neonatal intubation (“experts”) and 11 medical students (“novices”) performed two identical elective intubations on a neonatal patient simulator. Subjects were randomly assigned to either the intervention group, receiving predefined feedback between the two intubations, or the control group, receiving no feedback. Using the previously developed NISI, all intubations were assessed, both in real time and remotely on video. Construct validity was evaluated by (1) comparing the intubation performances, expressed as percentage scores, with and without feedback, and (2) correlating the intubation performances with the subjects' level of experience. The intrarater reliability, expressed as intraclass correlation coefficient (ICC), of real-time assessment compared with video-based assessment was determined. Results The intervention group contained 18 subjects, the control group 17. Background characteristics and baseline intubation scores were comparable in both groups. The median (IQR) change in percentage scores between the first and second intubation was significantly different between the intervention and control group (11.6% [4.7–22.8%] vs. 1.4% [0.0–5.7%], respectively; p = 0.013). The 95% CI for this 10.2% difference was 2.2 to 21.4%. The subjects' experience level correlated significantly with their percentage scores (Spearman's R = 0.70; p <0.01). ICC's were 0.95 (95% CI: 0.89–0.97) and 0.94 (95% CI: 0.89–0.97) for the first and second intubation, respectively. Conclusion Our NISI has construct validity and is reliable for real-time assessment. Key Points

scholarly journals A Promising Food-Coaching Intervention Program to Achieve Optimal Gestational Weight Gain in Overweight and Obese Pregnant Women: Pilot Randomized Controlled Trial of a Smartphone App (Preprint)

2018 ◽  
Author(s):  
Ling-Jun Li ◽  
Izzuddin M Aris ◽  
Wee Meng Han ◽  
Kok Hian Tan
Keyword(s):  
Weight Gain ◽  
Pregnant Women ◽  
Real Time ◽  
Gestational Weight Gain ◽  
Controlled Trial ◽  
Intervention Group ◽  
Smartphone App ◽  
Control Group ◽  
Gestational Weight ◽  
Randomized Controlled

BACKGROUND Traditional dietary recommendations for achieving optimal gestational weight gain are ineffective for pregnant women due to the lack of real-time communication and tedious consultation processes. OBJECTIVE In this pilot study, we aimed to determine the feasibility of a novel food-coaching smartphone app for controlling gestational weight gain and macronutrient intake among overweight and obese pregnant women. METHODS We designed a randomized controlled trial and recruited 30 overweight and obese pregnant women (1:1 ratio) during 18-20 weeks of gestation and followed them up after 4 and 8 weeks, respectively. Both groups received standard pregnancy dietary orientation at recruitment, while the intervention group received 8 weeks of real-time food coaching via a smartphone app. This food-coaching smartphone app (Glycoleap, Holmusk, Singapore) aimed to improve care and outcomes for people with diabetes. Pregnant women using this app were able to upload food images (eg, a picture of a meal, a drink, or a dessert) and received real-time and detailed food-coaching comments and guidance provided by professional dietitians during the day (8 AM to 8 PM). We recorded detailed characteristics during recruitment and examined anthropometry at all visits. We compared the mean differences of the 8-week gestational weight gain and macronutrient intake between the two groups. RESULTS Upon study completion, three subjects dropped out from the intervention, and one gave birth prematurely in the control group. The acceptance rate of the smartphone app was 90%. More participants achieved optimal gestational weight gain per week in the intervention group (8/12, 67%) than in the control group (5/14, 36%). After the 8-week intervention, women in the intervention group appeared to have lower gestational weight gain (mean difference=–0.08 kg; 95% CI –1.80 to 1.63) and cholesterol intake (mean difference=–31.73 mg; 95% CI –102.91 to 39.45) than those in the control group. CONCLUSIONS Our findings showed that this food-coaching smartphone app is feasible and favorable for weight gain control and cholesterol intake control among overweight and obese pregnant women. Although our results were not significant (perhaps, attributed to the small sample size), it provided proof of concept for the feasibility of applying such technology in future randomized controlled trials with a larger sample size, an earlier intervention onset, and a longer follow-up for overweight and obese pregnant women.

scholarly journals A Promising Food-Coaching Intervention Program to Achieve Optimal Gestational Weight Gain in Overweight and Obese Pregnant Women: Pilot Randomized Controlled Trial of a Smartphone App

10.2196/13013 ◽  
2019 ◽  
Vol 3 (4) ◽  
pp. e13013 ◽  
Author(s):  
Ling-Jun Li ◽  
Izzuddin M Aris ◽  
Wee Meng Han ◽  
Kok Hian Tan
Keyword(s):  
Weight Gain ◽  
Pregnant Women ◽  
Real Time ◽  
Gestational Weight Gain ◽  
Controlled Trial ◽  
Intervention Group ◽  
Smartphone App ◽  
Control Group ◽  
Gestational Weight ◽  
Randomized Controlled

Background Traditional dietary recommendations for achieving optimal gestational weight gain are ineffective for pregnant women due to the lack of real-time communication and tedious consultation processes. Objective In this pilot study, we aimed to determine the feasibility of a novel food-coaching smartphone app for controlling gestational weight gain and macronutrient intake among overweight and obese pregnant women. Methods We designed a randomized controlled trial and recruited 30 overweight and obese pregnant women (1:1 ratio) during 18-20 weeks of gestation and followed them up after 4 and 8 weeks, respectively. Both groups received standard pregnancy dietary orientation at recruitment, while the intervention group received 8 weeks of real-time food coaching via a smartphone app. This food-coaching smartphone app (Glycoleap, Holmusk, Singapore) aimed to improve care and outcomes for people with diabetes. Pregnant women using this app were able to upload food images (eg, a picture of a meal, a drink, or a dessert) and received real-time and detailed food-coaching comments and guidance provided by professional dietitians during the day (8 AM to 8 PM). We recorded detailed characteristics during recruitment and examined anthropometry at all visits. We compared the mean differences of the 8-week gestational weight gain and macronutrient intake between the two groups. Results Upon study completion, three subjects dropped out from the intervention, and one gave birth prematurely in the control group. The acceptance rate of the smartphone app was 90%. More participants achieved optimal gestational weight gain per week in the intervention group (8/12, 67%) than in the control group (5/14, 36%). After the 8-week intervention, women in the intervention group appeared to have lower gestational weight gain (mean difference=–0.08 kg; 95% CI –1.80 to 1.63) and cholesterol intake (mean difference=–31.73 mg; 95% CI –102.91 to 39.45) than those in the control group. Conclusions Our findings showed that this food-coaching smartphone app is feasible and favorable for weight gain control and cholesterol intake control among overweight and obese pregnant women. Although our results were not significant (perhaps, attributed to the small sample size), it provided proof of concept for the feasibility of applying such technology in future randomized controlled trials with a larger sample size, an earlier intervention onset, and a longer follow-up for overweight and obese pregnant women.

SleepSure: a pilot randomized-controlled trial to assess the effects of eye masks and earplugs on the quality of sleep for patients in hospital

2018 ◽  
Vol 33 (2) ◽  
pp. 253-261 ◽  
Author(s):  
Samaher Sweity ◽  
Andrew Finlay ◽  
Charlotte Lees ◽  
Adam Monk ◽  
Toshi Sherpa ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Length Of Stay ◽  
Sleep Quality ◽  
Controlled Trial ◽  
Intervention Group ◽  
Recruitment Rate ◽  
Control Group ◽  
Inpatient Stay ◽  
Open Label ◽  
Randomized Controlled

Objective: To determine the short-term effects of supplying hospital inpatients with earplugs and eye masks, preparatory to a full-scale trial. Design: A single-centre, open-label, two-arm, parallel group, randomized-controlled trial. Setting: A total of 13 medical and surgical wards in a large teaching hospital in the United Kingdom. Participants: Everyone admitted to hospital aged 18 years or older, who stayed overnight and had the mental capacity and sufficient understanding of English to give consent, the ability to complete the study questionnaire and the ability to use earplugs and eye masks unaided was considered. Interventions: The intervention group was provided with earplugs and eye masks for use the following night, and the control group received standard care. Main measures: Sleep quality assessed using the SleepSure questionnaire after the first night of using the intervention, use of earplugs and eye masks, number of falls throughout their inpatient stay, use of zopiclone during inpatient stay, length of stay and recruitment rate. Results: A total of 1600 patients were admitted; out of which, 626 (39%) were eligible and 206 (13% total, 33% eligible) recruited (intervention group, 109). The intervention group’s mean sleep quality score was 6.33 (95% confidence interval (CI): 5.89–6.77), compared with 5.09 (95% CI: 4.66–5.52) in the control group ( p < 0.001). There were no differences in use of zopiclone, falls or length of stay between the groups. Of the intervention group, 91 (86%) reported using the earplugs and/or eye masks. Conclusions: The intervention seems feasible, and effective, but trial eligibility rate and rate of recruitment into the study were limited.

Effectiveness of an Educational Intervention in Reducing New International Postgraduates’ Acculturative Stress in Malaysian Public Universities: Protocol for a Cluster Randomized Controlled Trial (Preprint)

2018 ◽  
Author(s):  
Musheer Abdulwahid Al-Jaberi ◽  
Muhamad Hanafiah Juni ◽  
Hayati Kadir Shahar ◽  
Siti Irma Fadhilah Ismail ◽  
Murad Abdu Saeed ◽  
...  
Keyword(s):  
International Students ◽  
Acculturative Stress ◽  
Educational Program ◽  
Public Universities ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Policy Makers ◽  
Randomized Controlled ◽  
Cluster Randomized

BACKGROUND Universities around the world, including Malaysia, have attracted many international students from different countries. Research has reported that acculturative stress resulting from international students’ attempts to adjust to the cultures of host countries is one of the most challenging issues that affects their lives in general and academic lives in particular. OBJECTIVE This study aims to examine the effectiveness of an educational intervention on acculturative stress among new postgraduate international students joining Malaysian public universities. METHODS A cluster randomized controlled trial design with Malaysian public universities as the unit of randomization will be used in this study. Public universities will be randomized in a 1:1 ratio to be either in the intervention (educational program) or control group (waiting list). Participants in the intervention group will receive 7 sessions in 9 hours delivered by an expert in psychology and the researcher. The control group will receive the intervention once the 3-month follow-up evaluation is completed. RESULTS The data will be analyzed using the generalized estimation equation with a confidence interval value of 95%; significant differences between and within groups are determined as <i>P</i>&lt;.05. The results of the study underlie the effectiveness of educational program in decreasing acculturative stress of new international students and enabling them to cope with a new environment. The results of this study will contribute to previous knowledge of acculturative stress, acculturation, and adjustment of international students. Furthermore, such results are expected to play a role in raising university policy makers’ awareness of their postgraduate international students’ acculturative stress issues and how they can help them avoid such stress and perform well in their academic life. CONCLUSIONS We expect that the intervention group will score significantly lower than the wait-list group on the immediate and 3-month postintervention evaluation of acculturative stress and achieve a higher level of adjustment. Results will have implications for international students, policy makers at universities, the Malaysian Ministry of Higher Education, and future research. CLINICALTRIAL Clinical Trials Registry India CTRI/2018/01/011223; http://ctri.nic.in/Clinicaltrials/showallp.php?mid1= 21978&amp;amp;EncHid=&amp;amp;userName=Muhamad%20Hanafiah%20Juni INTERNATIONAL REGISTERED REPORT PRR1-10.2196/12950

Effectiveness of a web-based medication adherence tool with patient centered communication: Results of a clustered randomized controlled trial (Preprint)

2019 ◽  
Author(s):  
Jan van Lieshout ◽  
Joyca Lacroix ◽  
Aart van Halteren ◽  
Martina Teichert
Keyword(s):  
Randomized Controlled Trial ◽  
Medication Adherence ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Community Pharmacies ◽  
Web Based ◽  
Randomized Controlled ◽  
Tailored Interventions ◽  
Increased Risk

BACKGROUND Growing numbers of people use medication for chronic conditions; non-adherence is common, leading to poor disease control. A newly developed web-based tool to identify an increased risk for non-adherence with related potential individual barriers might facilitate tailored interventions and improve adherence. OBJECTIVE To assess the effectiveness of the newly developed tool to improve medication adherence. METHODS A cluster randomized controlled trial assessed the effectiveness of this adherence tool in patients initiating cardiovascular or oral blood glucose lowering medication. Participants were included in community pharmacies. They completed an online questionnaire comprising an assessments of their risk for medication non-adherence and subsequently of barriers to adherence. In pharmacies belonging to the intervention group, individual barriers displayed in a graphical profile on a tablet were discussed by pharmacists and patients at high non-adherence risk in face to face meetings and shared with their general practitioners and practice nurses. Tailored interventions were initiated by the healthcare providers. Barriers of control patients were not presented or discussed and these patients received usual care. The primary outcome was the difference in medication adherence at 8 months follow-up between patients with an increased non-adherence risk from intervention and control group, calculated from dispensing data. RESULTS Data from 492 participants in 15 community pharmacies were available for analyses (intervention 253, 7 pharmacies; control 239, 8 pharmacies). The intervention had no effect on medication adherence (-0.01; 95%CI -0.59 – 0.57; P= .96), neither in the post hoc per protocol analysis (0.19; 95%CI -0.50 – 0.89; P=.58). CONCLUSIONS This study showed no effectiveness of a risk stratification and tailored intervention addressing personal barriers for medication adherence. Various potential explanations for lack of effect were identified. These explanations relate for instance to high medication adherence in the control group, study power and fidelity. Process evaluation should elicit possible improvements and inform the redesign of intervention and implementation. CLINICALTRIAL The Netherlands National Trial Register: NTR5186. Date: May 18, 2015 (http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=5186)

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