Pilot Feasibility Study of Therapeutic Hypothermia for Moderate to Severe Acute Respiratory Distress Syndrome.

PubMed

Slack, Donald F; Corwin, Douglas S; Shah, Nirav G; Shanholtz, Carl B; Verceles, Avelino C; Netzer, Giora; Jones, Kevin M; Brown, Clayton H; Terrin, Michael L; Hasday, Jeffrey D

2017-07-01

Prior studies suggest hypothermia may be beneficial in acute respiratory distress syndrome, but cooling causes shivering and increases metabolism. The objective of this study was to assess the feasibility of performing a randomized clinical trial of hypothermia in patients with acute respiratory distress syndrome receiving treatment with neuromuscular blockade because they cannot shiver. Retrospective study and pilot, prospective, open-label, feasibility study. Medical ICU. Retrospective review of 58 patients with acute respiratory distress syndrome based on Berlin criteria and PaO2/FIO2 less than 150 who received neuromuscular blockade. Prospective hypothermia treatment in eight acute respiratory distress syndrome patients with PaO2/FIO2 less than 150 receiving neuromuscular blockade. Cooling to 34-36°C for 48 hours. Core temperature, hemodynamics, serum glucose and electrolytes, and P/F were sequentially measured, and medians (interquartile ranges) presented, 28-day ventilator-free days, and hospital mortality were calculated in historical controls and eight cooled patients. Average patient core temperature was 36.7°C (36-37.3°C), and fever occurred during neuromuscular blockade in 30 of 58 retrospective patients. In the prospectively cooled patients, core temperature reached target range less than or equal to 4 hours of initiating cooling, remained less than 36°C for 92% of the 48 hours cooling period without adverse events, and was lower than the controls (34.35°C [34-34.8°C]; p < 0.0001). Compared with historical controls, the cooled patients tended to have lower hospital mortality (75% vs 53.4%; p = 0.26), more ventilator-free days (9 [0-21.5] vs 0 [0-12]; p = 0.16), and higher day 3 P/F (255 [160-270] vs 171 [120-214]; p = 0.024). Neuromuscular blockade alone does not cause hypothermia but allowed acute respiratory distress syndrome patients to be effectively cooled. Results support conducting a randomized clinical trial of hypothermia in acute respiratory distress syndrome and the feasibility of studying acute respiratory distress syndrome patients receiving neuromuscular blockade.

Assessment of Solid Cancer Treatment Feasibility in Older Patients: A Prospective Cohort Study

PubMed Central

Laurent, Marie; Paillaud, Elena; Tournigand, Christophe; Caillet, Philippe; Le Thuaut, Aurélie; Lagrange, Jean-Léon; Beauchet, Olivier; Vincent, Hélène; Carvahlo-Verlinde, Muriel; Culine, Stéphane; Bastuji-Garin, Sylvie

2014-01-01

Purpose. To assess solid cancer treatment feasibility in older patients Methods. Between 2007 and 2010, 385 consecutive elderly patients (mean age: 78.9 ± 5.4 years; 47.8% males) with solid malignancies referred to two geriatric oncology clinics were included prospectively. We recorded feasibility of first-line chemotherapy (planned number of cycles in patients without metastases and three to six cycles depending on tumor site in patients with metastases), surgery (patient alive 30 days after successfully performed planned surgical procedure), radiotherapy (planned dose delivered), and hormonal therapy (planned drug dose given), and we recorded overall 1-year survival. Results. Main tumor sites were colorectal (28.6%), breast (23.1%), and prostate (10.9%), and 47% of patients had metastases. Planned cancer treatment was feasible in 65.7% of patients with metastases; this proportion was 59.0% for chemotherapy, 82.6% for surgery, 100% for radiotherapy, and 85.2% for hormonal therapy. In the group without metastases, feasibility proportions were 86.8% overall, 72.4% for chemotherapy, 95.7% for surgery, 96.4% for radiotherapy, and 97.9% for hormonal therapy. Factors independently associated with chemotherapy feasibility were good functional status defined as Eastern Cooperative Oncology Group performance status <2 (p < .0001) or activities of daily living >5 (p = .01), normal mobility defined as no difficulty walking (p = .01) or no fall risk (p = .007), and higher creatinine clearance (p = .04). Conclusion. Feasibility rates were considerably lower for chemotherapy than for surgery, radiotherapy, and hormonal therapy. Therefore, utilization of limited geriatric oncology resources may be optimized by preferential referral of elderly cancer patients initially considered for chemotherapy to geriatric oncology clinics. PMID:24569945

HOspitals and patients WoRking in Unity (HOW R U?): telephone peer support to improve older patients’ quality of life after emergency department discharge in Melbourne, Australia—a multicentre prospective feasibility study

PubMed Central

Lennox, Alyse; Curtis, Andrea; Wilson, Gillian; Rosewarne, Cate; Smit, De Villiers; O’Brien, Debra; Browning, Colette Joy; Boyd, Lee; Smith, Cathie; Cameron, Peter

2018-01-01

Objectives To ascertain the feasibility and acceptability of the HOW R U? programme, a novel volunteer-peer postdischarge support programme for older patients after discharge from the emergency department (ED). Design A multicentre prospective mixed-methods feasibility study. Setting Two tertiary hospital EDs in metropolitan Melbourne, Australia. Participants A convenience sample of 39 discharged ED patients aged 70 years or over, with symptoms of social isolation, loneliness and/or depression. Intervention The HOW R U? intervention comprised weekly social support telephone calls delivered by volunteer peers for 3 months following ED discharge. Primary and secondary outcome measures The primary outcomes were feasibility of study processes, intervention acceptability to participants and retention in the programme. Secondary outcomes were changes in loneliness level (UCLA-3—3-item Loneliness Scale), mood (5-item Geriatric Depression Scale) and health-related quality of life (EQ-5D-5L and EQ-VAS) postintervention. Results Recruitment was feasible, with 30% of eligible patients successfully recruited. Seventeen volunteer peers provided telephone support to patient participants, in addition to their usual hospital volunteer role. HOW R U? was well received, with 87% retention in the patient group, and no attrition in the volunteer group. The median age of patients was 84 years, 64% were female, and 82% lived alone. Sixty-eight per cent of patients experienced reductions in depressive symptoms, and 53% experiencing reduced feelings of loneliness, and these differences were statistically significant Patient feedback was positive and volunteers reported great satisfaction with their new role. Conclusion HOW R U? was feasible in terms of recruitment and retention and was acceptable to both patients and volunteers. The overall results support the potential for further research in this area and provide data to support the design of a definitive trial to confirm the observed effects. Trial registration number ANZCTRN12615000715572; Results. PMID:29903788

A Pilot Prospective Study of Fetomaternal Hemorrhage Identified by Anemia in Asymptomatic Neonates

PubMed Central

Stroustrup, Annemarie; Plafkin, Callie

2016-01-01

Background Fetomaternal hemorrhage (FMH) is a poorly understood condition in which fetal erythrocytes transfer to the maternal circulation via a faulty placental barrier. Little is known about the true incidence, epidemiology, or pathophysiology of FMH in the general pregnant population as existing studies are based on retrospective cohorts and manifest diagnosis and selection bias. Objective To evaluate the practicability of a prospective study of fetomaternal hemorrhage in the general population based on antepartum maternal blood testing and neonatal anemia. Study Design Prospective cohort study. Result Nineteen pregnant women were enrolled prior to the term delivery of twenty well infants. Five neonates were unexpectedly anemic on first postnatal testing. Antenatal maternal blood samples associated with 2 of 5 anemic newborns had positive Kleihauer-Betke testing while no newborn with a normal postnatal blood count had an associated abnormal Kleihauer-Betke test. Conclusion Clinically significant FMH may be more common than previously thought. Prospective epidemiological study of FMH is feasible. PMID:26765555

A pilot prospective study of fetomaternal hemorrhage identified by anemia in asymptomatic neonates.

PubMed

Stroustrup, A; Plafkin, C

2016-05-01

Fetomaternal hemorrhage (FMH) is a poorly understood condition in which fetal erythrocytes transfer to the maternal circulation via a faulty placental barrier. Little is known about the true incidence, epidemiology or pathophysiology of FMH in the general pregnant population as existing studies are based on retrospective cohorts and manifest diagnosis and selection bias. The objective of this study was to evaluate the practicability of a prospective study of FMH in the general population based on antepartum maternal blood testing and neonatal anemia. Prospective cohort study. Nineteen pregnant women were enrolled prior to the term delivery of 20 well infants. Five neonates were unexpectedly anemic on first postnatal testing. Antenatal maternal blood samples associated with two of the five anemic newborns had positive Kleihauer-Betke testing while no newborn with a normal postnatal blood count had an associated abnormal Kleihauer-Betke test. Clinically significant FMH may be more common than previously thought. Prospective epidemiological study of FMH is feasible.

Perioperative ketorolac in high risk breast cancer patients. Rationale, feasibility and methodology of a prospective randomized placebo-controlled trial.

PubMed

Forget, Patrice; Berlière, Martine; van Maanen, Aline; Duhoux, Francois P; Machiels, Jean-Pascal; Coulie, Pierre G; Bouche, Gauthier; De Kock, Marc

2013-10-01

Ketorolac, a NSAID routinely used during surgery proposed to have anticancer effects, is a promising way to improve postoperative oncological outcome. This effect may be particularly prominent in patients with elevated preoperative inflammatory scores, like the neutrophil:lymphocyte ratio. In this paper, we describe the rationale, the preliminary analyses in our patients, the feasibility and the methodology of a prospective randomized trial called "Ketorolac in Breast Cancer trial" (KBCt) (NCT01806259). Copyright © 2013 Elsevier Ltd. All rights reserved.

Feasibility of Mossbauer survey meter for hydrocarbon and mineral reserves

NASA Technical Reports Server (NTRS)

Singh, J. J.

1975-01-01

The feasibility of developing a Mossbauer survey meter for geophysical prospecting was investigated. Various critical requirements that will have to be met by the source and absorber crystals in such an instrument were identified. It was concluded that a survey meter based on (Rh-103 resonance (40 kev) yields Rh-103) isomeric transition is feasible and should be developed.

7 CFR 4280.172 - Application eligibility provisions.

Code of Federal Regulations, 2014 CFR

2014-01-01

...-COOPERATIVE SERVICE AND RURAL UTILITIES SERVICE, DEPARTMENT OF AGRICULTURE LOANS AND GRANTS Rural Energy for America Program General Renewable Energy System Feasibility Study Grants § 4280.172 Application.... (b) Applications must be from the prospective owner(s) of the renewable energy system for which the...

7 CFR 4280.172 - Application eligibility provisions.

Code of Federal Regulations, 2013 CFR

2013-01-01

...-COOPERATIVE SERVICE AND RURAL UTILITIES SERVICE, DEPARTMENT OF AGRICULTURE LOANS AND GRANTS Rural Energy for America Program General Renewable Energy System Feasibility Study Grants § 4280.172 Application.... (b) Applications must be from the prospective owner(s) of the renewable energy system for which the...

7 CFR 4280.172 - Application eligibility provisions.

Code of Federal Regulations, 2012 CFR

2012-01-01

...-COOPERATIVE SERVICE AND RURAL UTILITIES SERVICE, DEPARTMENT OF AGRICULTURE LOANS AND GRANTS Rural Energy for America Program General Renewable Energy System Feasibility Study Grants § 4280.172 Application.... (b) Applications must be from the prospective owner(s) of the renewable energy system for which the...

75 FR 27708 - Takes of Marine Mammals Incidental to Specified Activities; Taking Marine Mammals Incidental to...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-05-18

... Survey As part of the feasibility study for Shell's Alaskan prospects a survey is required to identify...): (1) Tolerance Numerous studies have shown that pulsed sounds from airguns are often readily detectable in the water at distances of many kilometers. Numerous studies have also shown that marine mammals...

Social Capital and Health: A Review of Prospective Multilevel Studies

PubMed Central

Murayama, Hiroshi; Fujiwara, Yoshinori; Kawachi, Ichiro

2012-01-01

Background This article presents an overview of the concept of social capital, reviews prospective multilevel analytic studies of the association between social capital and health, and discusses intervention strategies that enhance social capital. Methods We conducted a systematic search of published peer-reviewed literature on the PubMed database and categorized studies according to health outcome. Results We identified 13 articles that satisfied the inclusion criteria for the review. In general, both individual social capital and area/workplace social capital had positive effects on health outcomes, regardless of study design, setting, follow-up period, or type of health outcome. Prospective studies that used a multilevel approach were mainly conducted in Western countries. Although we identified some cross-sectional multilevel studies that were conducted in Asian countries, including Japan, no prospective studies have been conducted in Asia. Conclusions Prospective evidence from multilevel analytic studies of the effect of social capital on health is very limited at present. If epidemiologic findings on the association between social capital and health are to be put to practical use, we must gather additional evidence and explore the feasibility of interventions that build social capital as a means of promoting health. PMID:22447212

Social capital and health: a review of prospective multilevel studies.

PubMed

Murayama, Hiroshi; Fujiwara, Yoshinori; Kawachi, Ichiro

2012-01-01

This article presents an overview of the concept of social capital, reviews prospective multilevel analytic studies of the association between social capital and health, and discusses intervention strategies that enhance social capital. We conducted a systematic search of published peer-reviewed literature on the PubMed database and categorized studies according to health outcome. We identified 13 articles that satisfied the inclusion criteria for the review. In general, both individual social capital and area/workplace social capital had positive effects on health outcomes, regardless of study design, setting, follow-up period, or type of health outcome. Prospective studies that used a multilevel approach were mainly conducted in Western countries. Although we identified some cross-sectional multilevel studies that were conducted in Asian countries, including Japan, no prospective studies have been conducted in Asia. Prospective evidence from multilevel analytic studies of the effect of social capital on health is very limited at present. If epidemiologic findings on the association between social capital and health are to be put to practical use, we must gather additional evidence and explore the feasibility of interventions that build social capital as a means of promoting health.

Accelerating Dynamic Magnetic Resonance Imaging (MRI) for Lung Tumor Tracking Based on Low-Rank Decomposition in the Spatial–Temporal Domain: A Feasibility Study Based on Simulation and Preliminary Prospective Undersampled MRI

DOE Office of Scientific and Technical Information (OSTI.GOV)

Sarma, Manoj; Department of Radiation Oncology, University of California, Los Angeles, California; Hu, Peng

Purpose: To evaluate a low-rank decomposition method to reconstruct down-sampled k-space data for the purpose of tumor tracking. Methods and Materials: Seven retrospective lung cancer patients were included in the simulation study. The fully-sampled k-space data were first generated from existing 2-dimensional dynamic MR images and then down-sampled by 5 × -20 × before reconstruction using a Cartesian undersampling mask. Two methods, a low-rank decomposition method using combined dynamic MR images (k-t SLR based on sparsity and low-rank penalties) and a total variation (TV) method using individual dynamic MR frames, were used to reconstruct images. The tumor trajectories were derived on the basis ofmore » autosegmentation of the resultant images. To further test its feasibility, k-t SLR was used to reconstruct prospective data of a healthy subject. An undersampled balanced steady-state free precession sequence with the same undersampling mask was used to acquire the imaging data. Results: In the simulation study, higher imaging fidelity and low noise levels were achieved with the k-t SLR compared with TV. At 10 × undersampling, the k-t SLR method resulted in an average normalized mean square error <0.05, as opposed to 0.23 by using the TV reconstruction on individual frames. Less than 6% showed tracking errors >1 mm with 10 × down-sampling using k-t SLR, as opposed to 17% using TV. In the prospective study, k-t SLR substantially reduced reconstruction artifacts and retained anatomic details. Conclusions: Magnetic resonance reconstruction using k-t SLR on highly undersampled dynamic MR imaging data results in high image quality useful for tumor tracking. The k-t SLR was superior to TV by better exploiting the intrinsic anatomic coherence of the same patient. The feasibility of k-t SLR was demonstrated by prospective imaging acquisition and reconstruction.« less

Quantitative assessment of the entire right ventricle from one acoustic window: an attractive approach.

PubMed

McGhie, Jackie S; Menting, Myrthe E; Vletter, Wim B; Frowijn, René; Roos-Hesselink, Jolien W; van der Zwaan, Heleen B; Soliman, Osama I I; Geleijnse, Marcel L; van den Bosch, Annemien E

2017-07-01

The aim of this prospective study was to evaluate the feasibility and establish normal values of functional right ventricle (RV) parameters as assessed in our four, long-axis view RV model using iRotate echocardiography. Furthermore, we evaluated the potential use of this model in patients with abnormally loaded RVs. One hundred and fifty-five healthy subjects aged 20-72 years (≥28 subjects per decile) were prospectively recruited. We used non-dedicated RV speckle-tracking software to test the feasibility and to establish normal range values of peak systolic global longitudinal RV strain (RV-GLS) from the RV free-walls (septum was excluded). Also normal range values for: dimensions, tricuspid annular plane systolic excursion (TAPSE) and tricuspid annular peak systolic velocity (TDI-S') were established. The feasibility of RV-GLS was 88, 84, and 62%, respectively, in the lateral, inferior, and anterior free wall. Mean RV-GLS normal values were -24.5 ± 4.9% for lateral wall and -25.4 ± 5.0% for anterior wall. Mean RV-GLS in the inferior wall was -23.2 ± 4.4% in the aortic (Ao) view and -20.7 ± 5.0% in the coronal (CV) view. The feasibility of mean RV-GLS was 100% in the anterior, lateral, and inferior walls in abnormally dilated RVs. The feasibility of all RV parameters assessed in the four-view iRotate model is good to excellent. Normal values for RV dimension and function of the anterior, inferior, and lateral RV walls have been established. Further studies and dedicated RV speckle-tracking software are warranted to discover the full potential of this new technique. Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2016. For permissions, please email: journals.permissions@oup.com.

Prospective study of the feasibility and effectiveness of a second-trimester quadruple test for Down syndrome in Thailand.

PubMed

Kaewsuksai, Peeranan; Jitsurong, Siroj

2017-11-01

To evaluate the feasibility and effectiveness of a quadruple test for Down syndrome in the second trimester of pregnancy in clinical settings in Thailand. From October 2015 to September 2016, a prospective study was undertaken in 19 hospitals in Songkhla province, Thailand. Women with a singleton pregnancy of 14-18 weeks were enrolled and underwent the quadruple test. The risk cutoff value was set at 1:250. All women with a positive test (risk ≥1:250) were offered amniocentesis. Women were followed up until delivery. Among 2375 women, 206 (8.7%) had a positive quadruple test; 98 (47.6%) of these women voluntarily underwent amniocentesis. Overall, seven pregnancies were complicated with chromosomal abnormalities (2.9 cases in 1000), including four cases of Down syndrome (1.7 in 1000) and three of other abnormalities. The detection, false-positive, and accuracy rates of the quadruple test for Down syndrome were 75.0%, 8.6%, and 91.4%, respectively. The quadruple test was found to be a feasible and efficient method for screening for Down syndrome in the second trimester of pregnancy in a Thai clinical setting. The test should be performed for pregnant women before an invasive test for Down syndrome. © 2017 International Federation of Gynecology and Obstetrics.

The European initiative for quality management in lung cancer care.

PubMed

Blum, Torsten G; Rich, Anna; Baldwin, David; Beckett, Paul; De Ruysscher, Dirk; Faivre-Finn, Corinne; Gaga, Mina; Gamarra, Fernando; Grigoriu, Bogdan; Hansen, Niels C G; Hubbard, Richard; Huber, Rudolf Maria; Jakobsen, Erik; Jovanovic, Dragana; Konsoulova, Assia; Kollmeier, Jens; Massard, Gilbert; McPhelim, John; Meert, Anne-Pascale; Milroy, Robert; Paesmans, Marianne; Peake, Mick; Putora, Paul-Martin; Scherpereel, Arnaud; Schönfeld, Nicolas; Sitter, Helmut; Skaug, Knut; Spiro, Stephen; Strand, Trond-Eirik; Taright, Samya; Thomas, Michael; van Schil, Paul E; Vansteenkiste, Johan F; Wiewrodt, Rainer; Sculier, Jean-Paul

2014-05-01

Lung cancer is the commonest cause of cancer-related death worldwide and poses a significant respiratory disease burden. Little is known about the provision of lung cancer care across Europe. The overall aim of the Task Force was to investigate current practice in lung cancer care across Europe. The Task Force undertook four projects: 1) a narrative literature search on quality management of lung cancer; 2) a survey of national and local infrastructure for lung cancer care in Europe; 3) a benchmarking project on the quality of (inter)national lung cancer guidelines in Europe; and 4) a feasibility study of prospective data collection in a pan-European setting. There is little peer-reviewed literature on quality management in lung cancer care. The survey revealed important differences in the infrastructure of lung cancer care in Europe. The European guidelines that were assessed displayed wide variation in content and scope, as well as methodological quality but at the same time there was relevant duplication. The feasibility study demonstrated that it is, in principle, feasible to collect prospective demographic and clinical data on patients with lung cancer. Legal obligations vary among countries. The European Initiative for Quality Management in Lung Cancer Care has provided the first comprehensive snapshot of lung cancer care in Europe.

A prospective observational study assessing the feasibility of measuring blood lead levels in New Zealand hunters eating meat harvested with lead projectiles.

PubMed

Buenz, Eric J; Parry, Gareth J; Bauer, Brent A; Matheny, Lauren M; Breukel, Klaasz

2017-03-01

There is no safe level of lead exposure. Correlations suggest that hunters harvesting wild game with lead bullets may be at risk of lead exposure through eating minute lead particles from shrapnel in their wild game. This feasibility study will determine if it is possible to conduct an interventional controlled, blinded study to evaluate if there is a causal relationship between meat harvested with lead bullets and elevated blood lead levels in those who consume the meat. This is an observational case crossover study and the primary outcome is blood lead levels. Individuals will have blood lead levels measured 2-4 days after eating one serving of meat harvested with lead bullets. At three potential washout periods these same individuals will have a subsequent blood lead level analysis. This observational study will provide the data necessary to determine the washout period and sample size for a prospective interventional study to evaluate if meat harvested with lead bullets raises blood-lead levels in those who consume the meat. This study has been approved by the Health and Disabilities Ethics Committees of New Zealand. NCT02775890.

Retrospective Validation of a Surveillance System for Unexplained Illness and Death: New Haven County, Connecticut

PubMed Central

Kluger, Michael D.; Sofair, Andre N.; Heye, Constance J.; Meek, James I.; Sodhi, Rajesh K.; Hadler, James L.

2001-01-01

Objectives. This study investigated retrospective validation of a prospective surveillance system for unexplained illness and death due to possibly infectious causes. Methods. A computerized search of hospital discharge data identified patients with potential unexplained illness and death due to possibly infectious causes. Medical records for such patients were reviewed for satisfaction of study criteria. Cases identified retrospectively were combined with prospectively identified cases to form a reference population against which sensitivity could be measured. Results. Retrospective validation was 41% sensitive, whereas prospective surveillance was 73% sensitive. The annual incidence of unexplained illness and death due to possibly infectious causes during 1995 and 1996 in the study county was conservatively estimated to range from 2.7 to 6.2 per 100 000 residents aged 1 to 49 years. Conclusions. Active prospective surveillance for unexplained illness and death due to possibly infectious causes is more sensitive than retrospective surveillance conducted through a published list of indicator codes. However, retrospective surveillance can be a feasible and much less labor-intensive alternative to active prospective surveillance when the latter is not possible or desired. PMID:11499106

Oncologic Therapy Support Via Means of a Dedicated Mobile App (OPTIMISE-1): Protocol for a Prospective Pilot Trial

PubMed Central

El Shafie, Rami A; Bougatf, Nina; Sprave, Tanja; Weber, Dorothea; Oetzel, Dieter; Machmer, Timo; Huber, Peter E; Debus, Jürgen

2018-01-01

Background The increasing role of consumer electronics and Web-enabled mobile devices in the medical sector opens up promising possibilities for integrating novel technical solutions into therapy and patient support for oncologic illnesses. A recent survey carried out at Heidelberg University Hospital suggested a high acceptance among patients for an additional approach to patient care during radiotherapy based on patient-reported outcomes by a dedicated mobile app. Objective The aim of this trial (OPTIMISE-1: Oncologic Therapy Support Via Means of a Dedicated Mobile App – A Prospective Feasibility Evaluation) is to prospectively evaluate the feasibility of employing a mobile app for the systematic support of radiooncological patients throughout the course of their radiotherapy by monitoring symptoms and patient performance, and facilitating the background-exchange of relevant information between patient and physician. Methods The present single-center, prospective, exploratory trial, conducted at Heidelberg University Hospital, assesses the feasibility of integrating an app-based approach into patient-care during radiotherapy. Patients undergoing curative radiotherapy for thoracic or pelvic tumors will be surveyed regarding general performance, treatment-related quality of life (QoL) and symptoms, and their need to personally consult a physician by means of a mobile app during treatment. The primary endpoint of feasibility will be reached when 80% of the patients have successfully answered 80% of their respective questions scheduled for each treatment day. Furthermore, treatment-related patient satisfaction and health-related QoL is assessed by the Patient Satisfaction Questionnaire Short Form (PSQ-18) and the European Organization for Research and Treatment of Cancer (EORTC) questionnaires at the beginning (baseline) and end of radiotherapy, and at the first follow-up. Results This trial will recruit 50 patients over a period of 12 months. Follow-up will be completed after 18 months, and publication of results is planned at 24 months after trial initiation. Conclusions This study will serve as a basis for future studies aiming to exploit the constant innovation in mobile medical appliances and integrate novel patient-centered concepts into patient care in the context of radiotherapy. Trial Registration ClinicalTrials.gov NCT03168048; https://clinicaltrials.gov/ct2/show/NCT03168048 (Archived at WebCite http://www.webcitation.org/6wtWGgi0X) PMID:29510971

Longitudinal falls data in Parkinson's disease: feasibility of fall diaries and effect of attrition.

PubMed

Hunter, Heather; Rochester, Lynn; Morris, Rosie; Lord, Sue

2017-06-02

Identifying causes of falls for people with Parkinson's disease has met with limited success. Prospective falls measurement using the "gold standard" approach is challenging. This paper examines the process and outcomes associated with longitudinal falls reporting in this population. Participants were recruited from ICICLE-GAIT (a collaborative study with ICICLE-PD; an incident cohort study). Monthly falls diaries were examined over 48 months for accuracy of data and rate of attrition. To further inform analysis, characteristics of participants with 36-month completed diaries were compared with those who did not complete diaries. One hundred and twenty-one participants were included at baseline. By 12 months, falls diary data had reduced to 107 participants; to 81 participants by 36 months; and to 59 participants by 48 months. Key reasons for diary attrition were withdrawal from ICICLE-gait (n = 16) (13.2%), and noncompliance (n = 11) (9.1%). The only significant difference between the completed and non-completed diary groups was age at 36 months, with older participants being more likely to send in diaries. Prospective falls data is feasible to collect over the long term. Attrition rates are high; however, participants retained in the study are overall representative of the total falls diary cohort. Implications for Rehabilitation Understanding falls evolution in Parkinson's disease through consistent, personalized monitoring of falls events is critical to inform effective management. Our study shows that it is feasible to collect longitudinal falls data using "gold standard" methodology, although significant resources are required for implementation. We anticipate that our study methodology is broadly applicable to any at-risk falls cohort including older adults and diverse neurological conditions. Researchers and clinicians collating prospective falls data must ensure that participants understand what constitutes a fall, as per the World Health Organization definition. A second key point is to ensure prompt recording of any fall event.

Automated Title Page Cataloging: A Feasibility Study.

ERIC Educational Resources Information Center

Weibel, Stuart; And Others

1989-01-01

Describes the design of a prototype rule-based system for the automation of descriptive cataloging from title pages. The discussion covers the results of tests of the prototype, major impediments to automatic cataloging from title pages, and prospects for further progress. The rules implemented in the prototype are appended. (16 references)…

Teledynamic Evaluation of Oropharyngeal Swallowing

ERIC Educational Resources Information Center

Malandraki, Georgia A.; McCullough, Gary; He, Xuming; McWeeny, Elizabeth; Perlman, Adrienne L.

2011-01-01

Purpose: The objective of the present investigation was to test the feasibility and clinical utility of a real-time Internet-based protocol for remote, telefluoroscopic evaluation of oropharyngeal swallowing. Method: In this prospective cohort study, the authors evaluated 32 patients with a primary diagnosis of stroke or head/neck cancer. All…

Safer laparoscopic trocar entry: it's all about pressure.

PubMed

Tsaltas, Jim; Pearce, Scott; Lawrence, Anthony; Meads, Alan; Mezzatesta, Joseph; Nicolson, Scott

2004-08-01

This prospective observational study aimed to assess the feasibility of adapting peritoneal hyperdistention to 25 mmHg during laparoscopy in an Australian hospital environment. A total of 1150 consecutive diagnostic or operative laparoscopies were performed. All cases were monitored for early detection of untoward physiological changes. All patients had Veress needle insufflation with distension to 25 mmHg prior to insertion of the primary trocar. No patients experienced any surgical entry complications or adverse clinical effects noted during anaesthetic. The aim of the current study is to assess the feasibility and safety of increasing the peritoneal insufflation pressure to 25 mmHg for primary trocar insertion.

Safety and feasibility of sublingual microcirculation assessment in the emergency department for civilian and military patients with traumatic haemorrhagic shock: a prospective cohort study

PubMed Central

Naumann, David N; Mellis, Clare; Smith, Iain M; Mamuza, Jasna; Skene, Imogen; Harris, Tim; Midwinter, Mark J; Hutchings, Sam D

2016-01-01

Objectives Sublingual microcirculatory monitoring for traumatic haemorrhagic shock (THS) may predict clinical outcomes better than traditional blood pressure and cardiac output, but is not usually performed until the patient reaches the intensive care unit (ICU), missing earlier data of potential importance. This pilot study assessed for the first time the feasibility and safety of sublingual video-microscopy for THS in the emergency department (ED), and whether it yields useable data for analysis. Setting A safety and feasibility assessment was undertaken as part of the prospective observational MICROSHOCK study; sublingual video-microscopy was performed at the UK-led Role 3 medical facility at Camp Bastion, Afghanistan, and in the ED in 3 UK Major Trauma Centres. Participants There were 15 casualties (2 military, 13 civilian) who presented with traumatic haemorrhagic shock with a median injury severity score of 26. The median age was 41; the majority (n=12) were male. The most common injury mechanism was road traffic accident. Primary and secondary outcome measures Safety and feasibility were the primary outcomes, as measured by lack of adverse events or clinical interruptions, and successful acquisition and storage of data. The secondary outcome was the quality of acquired video clips according to validated criteria, in order to determine whether useful data could be obtained in this emergency context. Results Video-microscopy was successfully performed and stored for analysis for all patients, yielding 161 video clips. There were no adverse events or episodes where clinical management was affected or interrupted. There were 104 (64.6%) video clips from 14 patients of sufficient quality for analysis. Conclusions Early sublingual microcirculatory monitoring in the ED for patients with THS is safe and feasible, even in a deployed military setting, and yields videos of satisfactory quality in a high proportion of cases. Further investigations of early microcirculatory behaviour in this context are warranted. Trial registration number NCT02111109. PMID:28003301

Feasibility of Conducting a Longitudinal, Transnational Study of Filipino Migrants to the United States: A Dual-Cohort Design

PubMed Central

Gee, Gilbert C.; de Castro, A.B.; Wang, May C.; Crespi, Catherine M.; Morey, Brittany N.; Fujishiro, Kaori

2015-01-01

Most studies of immigrant health are cross-sectional and fail to collect information prior to migration, leading to potential bias and confounding. The present pilot study examines the feasibility of studying migrants prospectively, with baseline data collected before migration. The study followed two cohorts of Filipinos for one year, a migrant cohort (n=27) that emigrated to the U.S. and a second non-migrant cohort (n=26) in the Philippines. The one-year retention rate was 96% The migrant cohort arrived in the U.S. within 2 months of their baseline assessment. Migrants and non-migrants did not differ with regard to body mass index, waist circumference or waist to hip ratio at baseline or at follow-up. It is feasible to conduct a transnational, longitudinal study of two cohorts of Filipinos. This design provides important pre-migration information, is analogous to a natural experiment, can be upscaled, and allows for a rigorous examination of immigrant health. PMID:25913346

HOspitals and patients WoRking in Unity (HOW R U?): telephone peer support to improve older patients' quality of life after emergency department discharge in Melbourne, Australia-a multicentre prospective feasibility study.

PubMed

Lowthian, Judy A; Lennox, Alyse; Curtis, Andrea; Wilson, Gillian; Rosewarne, Cate; Smit, De Villiers; O'Brien, Debra; Browning, Colette Joy; Boyd, Lee; Smith, Cathie; Cameron, Peter; Dale, Jeremy

2018-06-14

To ascertain the feasibility and acceptability of the HOW R U? programme, a novel volunteer-peer postdischarge support programme for older patients after discharge from the emergency department (ED). A multicentre prospective mixed-methods feasibility study. Two tertiary hospital EDs in metropolitan Melbourne, Australia. A convenience sample of 39 discharged ED patients aged 70 years or over, with symptoms of social isolation, loneliness and/or depression. The HOW R U? intervention comprised weekly social support telephone calls delivered by volunteer peers for 3 months following ED discharge. The primary outcomes were feasibility of study processes, intervention acceptability to participants and retention in the programme. Secondary outcomes were changes in loneliness level (UCLA-3-3-item Loneliness Scale), mood (5-item Geriatric Depression Scale) and health-related quality of life (EQ-5D-5L and EQ-VAS) postintervention. Recruitment was feasible, with 30% of eligible patients successfully recruited. Seventeen volunteer peers provided telephone support to patient participants, in addition to their usual hospital volunteer role. HOW R U? was well received, with 87% retention in the patient group, and no attrition in the volunteer group.The median age of patients was 84 years, 64% were female, and 82% lived alone. Sixty-eight per cent of patients experienced reductions in depressive symptoms, and 53% experiencing reduced feelings of loneliness, and these differences were statistically significant Patient feedback was positive and volunteers reported great satisfaction with their new role. HOW R U? was feasible in terms of recruitment and retention and was acceptable to both patients and volunteers. The overall results support the potential for further research in this area and provide data to support the design of a definitive trial to confirm the observed effects. ANZCTRN12615000715572; Results. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Duodenal Electric Stimulation: Results of a First-in-Man Study.

PubMed

Aberle, Jens; Busch, Philipp; Veigel, Jochen; Duprée, Anna; Roesch, Thomas; zu Eulenburg, Christine; Paschen, Björn; Scholz, Bernd M; Wolter, Stefan; Sauer, Nina; Ludwig, Kaja; Izbicki, Jakob; Mann, Oliver

2016-02-01

The aim of this study was to demonstrate feasibility and safety of a new electric duodenal stimulation system (EDS, BALANCE) in humans. Secondary objectives were to evaluate the effect on glycemic control and weight loss in patients with obesity and type 2 diabetes mellitus (T2DM). In an open-labeled, prospective, single-arm, non-randomized multicenter study, 12 obese T2DM patients with a mean HbA1c of 8.0% received laparoscopic implantation of the BALANCE duodenal stimulating device. Adverse events, changes in glycemic control, cardiovascular parameters, and weight were collected. The follow-up period after implantation was 12 months. Device related severe adverse events did not occur. Mean HbA1c decreased by 0.8% (p = 0.02) and mean fasting blood glucose level (FBG) was reduced by 19% (p = 0.038) after the 12 months. Mean HDL level increased from 44 to 48 mg/dl (p = 0.033). EDS is a feasible and safe procedure. Positive effects on T2DM and some cardiovascular parameters (HDL, weight) were seen. However, further prospective randomized blinded studies are needed in order to evaluate the potential of this new minimally invasive method.

Feasibility study of a swept frequency electromagnetic probe (SWEEP) using inductive coupling for the determination of subsurface conductivity of the earth and water prospecting in arid regions

NASA Technical Reports Server (NTRS)

Latorraca, G. A.; Bannister, L. H.

1974-01-01

Techniques developed for electromagnetic probing of the lunar interior, and techniques developed for the generation of high power audio frequencies were combined to make practical a magnetic inductive coupling system for the rapid measurement of ground conductivity profiles which are helpful when prospecting for the presence and quality of subsurface water. A system which involves the measurement of the direction, intensity, and time phase of the magnetic field observed near the surface of the earth at a distance from a horizontal coil energized so as to create a field that penetrates the earth was designed and studied to deduce the conductivity and stratification of the subsurface. Theoretical studies and a rudimentary experiment in an arid region showed that the approach is conceptually valid and that this geophysical prospecting technique can be developed for the economical exploration of subterranean water resources.

Methods of Selecting Industries for Depressed Areas--An Introduction to Feasibility Studies. Developing Job Opportunities 2.

ERIC Educational Resources Information Center

Klaassen, Leo H.

This report presents severl alternative methods which may be employed by local authorities in identifying likely prospects for local industrialization, and describes a specialized input-output technique to define inter-industry relations and inter-regional relations of industries. This technique is applied, for illustrative purposes, to three…

Atrial Fibrillation Screening in Nonmetropolitan Areas Using a Telehealth Surveillance System With an Embedded Cloud-Computing Algorithm: Prospective Pilot Study

PubMed Central

Chen, Ying-Hsien; Hung, Chi-Sheng; Huang, Ching-Chang; Hung, Yu-Chien

2017-01-01

Background Atrial fibrillation (AF) is a common form of arrhythmia that is associated with increased risk of stroke and mortality. Detecting AF before the first complication occurs is a recognized priority. No previous studies have examined the feasibility of undertaking AF screening using a telehealth surveillance system with an embedded cloud-computing algorithm; we address this issue in this study. Objective The objective of this study was to evaluate the feasibility of AF screening in nonmetropolitan areas using a telehealth surveillance system with an embedded cloud-computing algorithm. Methods We conducted a prospective AF screening study in a nonmetropolitan area using a single-lead electrocardiogram (ECG) recorder. All ECG measurements were reviewed on the telehealth surveillance system and interpreted by the cloud-computing algorithm and a cardiologist. The process of AF screening was evaluated with a satisfaction questionnaire. Results Between March 11, 2016 and August 31, 2016, 967 ECGs were recorded from 922 residents in nonmetropolitan areas. A total of 22 (2.4%, 22/922) residents with AF were identified by the physician’s ECG interpretation, and only 0.2% (2/967) of ECGs contained significant artifacts. The novel cloud-computing algorithm for AF detection had a sensitivity of 95.5% (95% CI 77.2%-99.9%) and specificity of 97.7% (95% CI 96.5%-98.5%). The overall satisfaction score for the process of AF screening was 92.1%. Conclusions AF screening in nonmetropolitan areas using a telehealth surveillance system with an embedded cloud-computing algorithm is feasible. PMID:28951384

Symptoms and Needs of Head and Neck Cancer Patients at Diagnosis of Incurability - Prevalences, Clinical Implications, and Feasibility of a Prospective Longitudinal Multicenter Cohort Study.

PubMed

Alt-Epping, Bernd; Seidel, Wiebke; Vogt, Jeannette; Mehnert, Anja; Thomas, Michael; van Oorschot, Birgitt; Wolff, Hendrik; Schliephake, Henning; Canis, Martin; Dröge, Leif H; Nauck, Friedemann; Lordick, Florian

2016-01-01

Little is known about the physical symptoms and psychosocial burden of patients at the time of diagnosis of an incurable situation, although cancer treatment guidelines demand early assessment and integration of palliative care concepts, beginning from the diagnosis of incurability. Therefore, we initiated a prospective longitudinal multicenter cohort study assessing the symptoms and needs of patients suffering from incurable cancer (various entities), from the time of diagnosing incurability (i.e., before palliative anticancer treatment was initiated) and in 3-monthly intervals thereafter, by using validated self-reporting tools. Here, we focus on patients with head and neck cancer and present preliminary results on symptoms and need prevalences, on clinical implications, and on the feasibility of a methodologically complex assessment procedure in a particularly vulnerable study population. 22 patients completed the first visit. The Eastern Cooperative Oncology Group (ECOG) performance scores and most physical symptoms and psychosocial items varied between the extremes, from a virtually uncompromised condition to extremely perceived symptoms and needs. If intense face-to-face study support was provided, the study concept proved to be feasible, despite the complexity of assessment, problems in interdisciplinary and patient communication, comorbidities, and early death from complications. The striking variability in the perceived symptom and need intensities requires a highly individualized approach. For clinical purposes, a less complex screening procedure would be desirable, in order to enable a routine, early and comprehensive support, including palliative care services. © 2016 S. Karger GmbH, Freiburg.

Feasibility and safety of augmented-reality glass for computed tomography-assisted percutaneous revascularization of coronary chronic total occlusion: A single center prospective pilot study.

PubMed

Opolski, Maksymilian P; Debski, Artur; Borucki, Bartosz A; Staruch, Adam D; Kepka, Cezary; Rokicki, Jakub K; Sieradzki, Bartosz; Witkowski, Adam

2017-11-01

Percutaneous coronary intervention (PCI) of chronic total occlusion (CTO) may be facilitated by projection of coronary computed tomography angiography (CTA) datasets in the catheterization laboratory. There is no data on the feasibility and safety outcomes of CTA-assisted CTO PCI using a wearable augmented-reality glass. A total of 15 patients scheduled for elective antegrade CTO intervention were prospectively enrolled and underwent preprocedural coronary CTA. Three-dimensional and curved multiplanar CT reconstructions were transmitted to a head-mounted hands-free computer worn by interventional cardiologists during CTO PCI to provide additional information on CTO tortuosity and calcification. The results of CTO PCI using a wearable computer were compared with a time-matched prospective angiographic registry of 59 patients undergoing antegrade CTO PCI without a wearable computer. Operators' satisfaction was assessed by a 5-point Likert scale. Mean age was 64 ± 8 years and the mean J-CTO score was 2.1 ± 0.9 in the CTA-assisted group. The voice-activated co-registration and review of CTA images in a wearable computer during CTO PCI were feasible and highly rated by PCI operators (4.7/5 points). There were no major adverse cardiovascular events. Compared with standard CTO PCI, CTA-assisted recanalization of CTO using a wearable computer showed more frequent selection of the first-choice stiff wire (0% vs 40%, p < 0.001) and lower contrast exposure (166 ± 52 vs 134 ± 43 ml, p = 0.03). Overall CTO success rates and safety outcomes remained similar between both groups. CTA-assisted CTO PCI using an augmented-reality glass is feasible and safe, and might reduce the resources required for the interventional treatment of CTO. Copyright © 2017 Society of Cardiovascular Computed Tomography. Published by Elsevier Inc. All rights reserved.

HOspitals and patients WoRking in Unity (HOW R U?): protocol for a prospective feasibility study of telephone peer support to improve older patients' quality of life after emergency department discharge.

PubMed

Lowthian, Judy A; Lennox, Alyse; Curtis, Andrea; Dale, Jeremy; Browning, Colette; Smit, De Villiers; Wilson, Gillian; O'Brien, Debra; Rosewarne, Cate; Boyd, Lee; Garner, Cath; Cameron, Peter

2016-12-02

Older people presenting to an emergency department (ED) have a higher likelihood of social isolation, loneliness and depression; which are all associated with negative health outcomes and increased health service use, including higher rates of ED attendance. The HOW R U? study aims to ascertain the feasibility and acceptability of a postdischarge telephone support programme for older ED patients following discharge. The intervention, which aims to improve quality of life, will be delivered by hospital-based volunteers. A multicentre prospective uncontrolled feasibility study will enrol 50 community-dwelling patients aged ≥70 years with symptoms of loneliness or depression who are discharged home within 72 hours from the ED or acute medical ward. Participants will receive weekly supportive telephone calls over a 3-month period from a volunteer-peer. Feasibility will be assessed in terms of recruitment, acceptability of the intervention to participants and level of retention in the programme. Changes in level of loneliness (UCLA-3 item Loneliness Scale), mood (Geriatric Depression Scale-5 item) and health-related quality of life (EQ-5D-5L and EQ-VAS) will also be measured postintervention (3 months). Research ethics and governance committee approval has been granted for this study by each participating centre (reference: 432/15 and 12-09-11-15). Study findings will inform the design and conduct of a future multicentre randomised controlled trial of a postdischarge volunteer-peer telephone support programme to improve social isolation, loneliness or depressive symptoms in older patients. Results will be disseminated through peer-reviewed journal publication, and conference and seminar presentation. ACTRN12615000715572, Pre-results. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.

Multicenter pilot study of radiochemotherapy as first-line treatment for adults with medulloblastoma (NOA-07).

PubMed

Beier, Dagmar; Proescholdt, Martin; Reinert, Christiane; Pietsch, Torsten; Jones, David T W; Pfister, Stefan M; Hattingen, Elke; Seidel, Clemens; Dirven, Linda; Luerding, Ralf; Reijneveld, Jaap; Warmuth-Metz, Monika; Bonsanto, Matteo; Bremer, Michael; Combs, Stephanie E; Rieken, Stefan; Herrlinger, Ulrich; Kuntze, Holger; Mayer-Steinacker, Regine; Moskopp, Dag; Schneider, Thomas; Beringer, Andreas; Schlegel, Uwe; Stummer, Walter; Welker, Helmut; Weyerbrock, Astrid; Paulsen, Frank; Rutkowski, Stefan; Weller, Michael; Wick, Wolfgang; Kortmann, Rolf-Dieter; Bogdahn, Ulrich; Hau, Peter

2018-02-19

Medulloblastoma in adult patients is rare, with 0.6 cases per million. Prognosis depends on clinical factors and medulloblastoma entity. No prospective data on the feasibility of radiochemotherapy exist. The German Neuro-Oncology Working Group (NOA) performed a prospective descriptive multicenter single-arm phase II trial to evaluate feasibility and toxicity of radio-polychemotherapy. The NOA-07 trial combined craniospinal irradiation with vincristine, followed by 8 cycles of cisplatin, lomustine, and vincristine. Adverse events, imaging and progression patterns, histological and genetic markers, health-related quality of life (HRQoL), and cognition were evaluated. Primary endpoint was the rate of toxicity-related treatment terminations after 4 chemotherapy cycles, and the toxicity profile. The feasibility goal was reached if at least 45% of patients received at least 4 cycles of maintenance chemotherapy. Thirty patients were evaluable. Each 50% showed classic and desmoplastic/nodular histology. Sixty-seven percent were classified into the sonic hedgehog (SHH) subgroup without TP53 alterations, 13% in wingless (WNT), and 17% in non-WNT/non-SHH. Four cycles of chemotherapy were feasible in the majority (n = 21; 70.0%). Hematological side effects and polyneuropathy were prevalent toxicities. During the active treatment period, HRQoL and verbal fluency improved significantly. The 3-year event-free survival rate was 66.6% at the time of databank lock. Radio-polychemotherapy did lead to considerable toxicity and a high amount of dose reductions throughout the first 4 chemotherapy cycles that may affect efficacy. Thus, we propose frequent patient surveillance using this regimen. Modifications of the regimen may increase feasibility of radio-polychemotherapy of adult patients with medulloblastoma. © The Author(s) 2017. Published by Oxford University Press on behalf of the Society for Neuro-Oncology. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com

Functional recovery following critical illness in children: the "wee-cover" pilot study.

PubMed

Choong, Karen; Al-Harbi, Samah; Siu, Katie; Wong, Katie; Cheng, Ji; Baird, Burke; Pogorzelski, David; Timmons, Brian; Gorter, Jan-Willem; Thabane, Lehana; Khetani, Mary

2015-05-01

To determine the feasibility of conducting a longitudinal prospective study to evaluate functional recovery and predictors of impaired functional recovery in critically ill children. Prospective pilot study. Single-center PICU at McMaster Children's Hospital, Hamilton, Canada. Children aged 12 months to 17 years, with at least one organ dysfunction, limited mobility or bed rest during the first 48 hours of PICU admission, and a minimum 48-hour PICU length of stay, were eligible. Patients transferred from a neonatal ICU prior to ever being discharged home, already mobilizing well or at baseline functional status at time of screening, with an English language barrier, and prior enrollment into this study, were excluded. None. The primary outcome was feasibility, as defined by the ability to screen, enroll eligible patients, and execute the study procedures and measurements on participants. Secondary outcomes included functional status at baseline, 3 and 6 months, PICU morbidity, and mortality. Functional status was measured using the Pediatric Evaluation of Disability Inventory and the Participation and Environment Measure for Children and Youth. Thirty-three patients were enrolled between October 2012 and April 2013. Consent rate was 85%, and follow-up rates were 93% at 3 months and 71% at 6 months. We were able to execute the study procedures and measurements, demonstrating feasibility of conducting a future longitudinal study. Functional status deteriorated following critical illness. Recovery appears to be influenced by baseline health or functional status and severity of illness. Longitudinal research is needed to understand how children recover after a critical illness. Our results suggest factors that may influence the recovery trajectory and were used to inform the methodology, outcomes of interest, and appropriate sample size of a larger multicenter study evaluating functional recovery in this population.

Robotic radical hysterectomy with pelvic lymphadenectomy: our early experience.

PubMed

Vasilescu, C; Sgarbură, O; Tudor, St; Popa, M; Turcanu, A; Florescu, A; Herlea, V; Anghel, R

2009-01-01

Robotic surgery overcomes some limitations of laparoscopic surgery for prostate, rectal and uterine cancer. In this study we analyze the feasibility of robotic radical hysterectomy with pelvic lymphadenectomy in gynecological cancers in a developping program of robotic surgery. This prospective study started the 1st of March 2008. Since then, 250 cases of robotic surgery were performed out of which 29 cases addressed gynecological conditions. We selected all radical interventions summing up to 19 cases. Our final group consisted of 19 patients, a gedbetween 30 and 78 years old, with an average age of 53.22 years (+/- 10.03). Twelve patients were diagnosed with cervical cancer, the rest of them with endometrial cancer. Mean operative time was 180 +/- 23.45 min. Oral intake were started the next day after the operation and the patients were discharged 3.5 (+/- 1.2) days postoperatively. There were 3 urinary complications in patients with tumors adherent to the urinary bladder. We believe that robotic radical hysterectomy with pelvic lymphadenectomy in gynecological cancers is a rapid, feasible, and secure method that should be used whenever available. However further prospective studies and late follow-up results are needed in order to fully assess the value of this new technology.

Results of a Test and Win Contest to Raise Radon Awareness in Urban and Rural Settings

ERIC Educational Resources Information Center

Hahn, Ellen J.; Rayens, Mary Kay; Kercsmar, Sarah E.; Robertson, Heather; Adkins, Sarah M.

2014-01-01

Background: Radon is a leading cause of lung cancer, but few test their homes to determine radon levels. Purpose: The study assessed feasibility and success of a Test and Win Contest to promote radon testing in rural and urban communities. Methods: The prospective, quasi-experimental study tested a novel contest to raise radon awareness. Paid and…

Imaging of thrombi and assessment of left atrial appendage function: a prospective study comparing transthoracic and transoesophageal echocardiography

PubMed Central

Omran, H; Jung, W; Rabahieh, R; Wirtz, P; Becher, H; Illien, S; Schimpf, R; Luderitz, B

1999-01-01

Objective—To compare the value of current transthoracic echocardiographic systems and transoesophageal echocardiography for assessing left atrial appendage function and imaging thrombi.
Design—Single blind prospective study. Patients were first investigated by transthoracic echocardiography and thereafter by a second investigator using transoesophageal echocardiography. The feasibility of imaging the left atrial appendage, recording its velocities, and identifying thrombi within the appendage were determined by both methods.
Patients—117 consecutive patients with a stroke or transient neurological deficit.
Setting—Tertiary cardiac and neurological care centre.
Results—Imaging of the complete appendage was feasible in 75% of the patients by transthoracic echocardiography and in 95% by transoesophageal echocardiography. Both methods were concordant for the detection of thrombi in 10 cases. Transoesophageal echocardiography revealed two additional thrombi. In one of these patients, transthoracic echocardiography was not feasible and in the other the thrombus had been missed by transthoracic examination. In patients with adequate transthoracic echogenicity, the specificity and sensitivity of detecting left atrial appendage thrombi were 100% and 91%, respectively. Recording of left atrial appendage velocities by transthoracic echocardiography was feasible in 69% of cases. None of the patients with a velocity > 0.3 m/s had left atrial appendage thrombi. In the one patient in whom transthoracic echocardiographic evaluation missed a left atrial appendage thrombus, the peak emptying velocity of the left atrial appendage was 0.25 m/s.
Conclusions—A new generation echocardiographic system allows for the transthoracic detection of left atrial appendage thrombi and accurate determination of left atrial appendage function in most patients with a neurological deficit.

 Keywords: echocardiography; left atrial appendage thrombi; stroke; thromboembolism PMID:9922358

Oncologic Therapy Support Via Means of a Dedicated Mobile App (OPTIMISE-1): Protocol for a Prospective Pilot Trial.

PubMed

El Shafie, Rami A; Bougatf, Nina; Sprave, Tanja; Weber, Dorothea; Oetzel, Dieter; Machmer, Timo; Huber, Peter E; Debus, Jürgen; Nicolay, Nils H

2018-03-06

The increasing role of consumer electronics and Web-enabled mobile devices in the medical sector opens up promising possibilities for integrating novel technical solutions into therapy and patient support for oncologic illnesses. A recent survey carried out at Heidelberg University Hospital suggested a high acceptance among patients for an additional approach to patient care during radiotherapy based on patient-reported outcomes by a dedicated mobile app. The aim of this trial (OPTIMISE-1: Oncologic Therapy Support Via Means of a Dedicated Mobile App - A Prospective Feasibility Evaluation) is to prospectively evaluate the feasibility of employing a mobile app for the systematic support of radiooncological patients throughout the course of their radiotherapy by monitoring symptoms and patient performance, and facilitating the background-exchange of relevant information between patient and physician. The present single-center, prospective, exploratory trial, conducted at Heidelberg University Hospital, assesses the feasibility of integrating an app-based approach into patient-care during radiotherapy. Patients undergoing curative radiotherapy for thoracic or pelvic tumors will be surveyed regarding general performance, treatment-related quality of life (QoL) and symptoms, and their need to personally consult a physician by means of a mobile app during treatment. The primary endpoint of feasibility will be reached when 80% of the patients have successfully answered 80% of their respective questions scheduled for each treatment day. Furthermore, treatment-related patient satisfaction and health-related QoL is assessed by the Patient Satisfaction Questionnaire Short Form (PSQ-18) and the European Organization for Research and Treatment of Cancer (EORTC) questionnaires at the beginning (baseline) and end of radiotherapy, and at the first follow-up. This trial will recruit 50 patients over a period of 12 months. Follow-up will be completed after 18 months, and publication of results is planned at 24 months after trial initiation. This study will serve as a basis for future studies aiming to exploit the constant innovation in mobile medical appliances and integrate novel patient-centered concepts into patient care in the context of radiotherapy. ClinicalTrials.gov NCT03168048; https://clinicaltrials.gov/ct2/show/NCT03168048 (Archived at WebCite http://www.webcitation.org/6wtWGgi0X). ©Rami A El Shafie, Nina Bougatf, Tanja Sprave, Dorothea Weber, Dieter Oetzel, Timo Machmer, Peter E Huber, Jürgen Debus, Nils H Nicolay. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 06.03.2018.

Archeological Echocardiography: Digitization and Speckle Tracking Analysis of Archival Echocardiograms in the HyperGEN Study.

PubMed

Aguilar, Frank G; Selvaraj, Senthil; Martinez, Eva E; Katz, Daniel H; Beussink, Lauren; Kim, Kwang-Youn A; Ping, Jie; Rasmussen-Torvik, Laura; Goyal, Amita; Sha, Jin; Irvin, Marguerite R; Arnett, Donna K; Shah, Sanjiv J

2016-03-01

Several large epidemiologic studies and clinical trials have included echocardiography, but images were stored in analog format and these studies predated tissue Doppler imaging (TDI) and speckle tracking echocardiography (STE). We hypothesized that digitization of analog echocardiograms, with subsequent quantification of cardiac mechanics using STE, is feasible, reproducible, accurate, and produces clinically valid results. In the NHLBI HyperGEN study (N = 2234), archived analog echocardiograms were digitized and subsequently analyzed using STE to obtain tissue velocities/strain. Echocardiograms were assigned quality scores and inter-/intra-observer agreement was calculated. Accuracy was evaluated in: (1) a separate second study (N = 50) comparing prospective digital strain versus post hoc analog-to-digital strain, and (2) in a third study (N = 95) comparing prospectively obtained TDI e' velocities with post hoc STE e' velocities. Finally, we replicated previously known associations between tissue velocities/strain, conventional echocardiographic measurements, and clinical data. Of the 2234 HyperGEN echocardiograms, 2150 (96.2%) underwent successful digitization and STE analysis. Inter/intra-observer agreement was high for all STE parameters, especially longitudinal strain (LS). In accuracy studies, LS performed best when comparing post hoc STE to prospective digital STE for strain analysis. STE-derived e' velocities correlated with, but systematically underestimated, TDI e' velocity. Several known associations between clinical variables and cardiac mechanics were replicated in HyperGEN. We also found a novel independent inverse association between fasting glucose and LS (adjusted β = -2.4 [95% CI -3.6, -1.2]% per 1-SD increase in fasting glucose; P < 0.001). Archeological echocardiography, the digitization and speckle tracking analysis of archival echocardiograms, is feasible and generates indices of cardiac mechanics similar to contemporary studies. © 2015, Wiley Periodicals, Inc.

Archeological Echocardiography: Digitization and Speckle-Tracking Analysis of Archival Echocardiograms in the HyperGEN Study

PubMed Central

Aguilar, Frank G.; Selvaraj, Senthil; Martinez, Eva E.; Katz, Daniel H.; Beussink, Lauren; Kim, Kwang-Youn A.; Ping, Jie; Rasmussen-Torvik, Laura; Goyal, Amita; Sha, Jin; Irvin, Marguerite R.; Arnett, Donna K.; Shah, Sanjiv J.

2015-01-01

Background Several large epidemiologic studies and clinical trials have included echocardiography, but images were stored in analog format and these studies predated tissue Doppler imaging (TDI) and speckle-tracking echocardiography (STE). We hypothesized that digitization of analog echocardiograms, with subsequent quantification of cardiac mechanics using STE, is feasible, reproducible, accurate, and produces clinically valid results. Methods In the NHLBI HyperGEN study (N=2234), archived analog echocardiograms were digitized and subsequently analyzed using STE to obtain tissue velocities/strain. Echocardiograms were assigned quality scores and inter/intraobserver agreement was calculated. Accuracy was evaluated in (1) a separate second study (N=50) comparing prospective digital strain vs. post-hoc analog-to-digital strain; and (2) in a third study (N=95) comparing prospectively-obtained TDI e′ velocities with post-hoc STE e′ velocities. Finally, we replicated previously known associations between tissue velocities/strain, conventional echocardiographic measurements, and clinical data. Results Of the 2234 HyperGEN echocardiograms, 2150 (96.2%) underwent successful digitization and STE analysis. Inter/intraobserver agreement was high for all STE parameters, especially longitudinal strain (LS). In accuracy studies, LS performed best when comparing post-hoc STE to prospective digital STE for strain analysis. STE-derived e′ velocities correlated with, but systematically underestimated, TDI e′ velocity. Several known associations between clinical variables and cardiac mechanics were replicated in HyperGEN. We also found a novel independent inverse association between fasting glucose and LS (adjusted β =−2.4 [95% CI −3.6,−1.2]% per 1-SD increase in fasting glucose; P<0.001). Conclusions Archeological echocardiography, the digitization and speckle-tracking analysis of archival echocardiograms, is feasible and generates parameters of cardiac mechanics similar to contemporary studies. PMID:26525308

Compressed-Sensing Multi-Spectral Imaging of the Post-Operative Spine

PubMed Central

Worters, Pauline W.; Sung, Kyunghyun; Stevens, Kathryn J.; Koch, Kevin M.; Hargreaves, Brian A.

2012-01-01

Purpose To apply compressed sensing (CS) to in vivo multi-spectral imaging (MSI), which uses additional encoding to avoid MRI artifacts near metal, and demonstrate the feasibility of CS-MSI in post-operative spinal imaging. Materials and Methods Thirteen subjects referred for spinal MRI were examined using T2-weighted MSI. A CS undersampling factor was first determined using a structural similarity index as a metric for image quality. Next, these fully sampled datasets were retrospectively undersampled using a variable-density random sampling scheme and reconstructed using an iterative soft-thresholding method. The fully- and under-sampled images were compared by using a 5-point scale. Prospectively undersampled CS-MSI data were also acquired from two subjects to ensure that the prospective random sampling did not affect the image quality. Results A two-fold outer reduction factor was deemed feasible for the spinal datasets. CS-MSI images were shown to be equivalent or better than the original MSI images in all categories: nerve visualization: p = 0.00018; image artifact: p = 0.00031; image quality: p = 0.0030. No alteration of image quality and T2 contrast was observed from prospectively undersampled CS-MSI. Conclusion This study shows that the inherently sparse nature of MSI data allows modest undersampling followed by CS reconstruction with no loss of diagnostic quality. PMID:22791572

Evaluation of Buccal Cell Samples for Studies of Oral Microbiota.

PubMed

Yu, Guoqin; Phillips, Steve; Gail, Mitchell H; Goedert, James J; Humphrys, Michael; Ravel, Jacques; Ren, Yanfang; Caporaso, Neil E

2017-02-01

The human microbiota is postulated to affect cancer risk, but collecting microbiota specimens with prospective follow-up for diseases will take time. Buccal cell samples have been obtained from mouthwash for the study of human genomic DNA in many cohort studies. Here, we evaluate the feasibility of using buccal cell samples to examine associations of human microbiota and disease risk. We obtained buccal cells from mouthwash in 41 healthy participants using a protocol that is widely employed to obtain buccal cells for the study of human DNA. We compared oral microbiota from buccal cells with that from eight other oral sample types collected by following the protocols of the Human Microbiome Project. Microbiota profiles were determined by sequencing 16S rRNA gene V3-V4 region. Compared with each of the eight other oral samples, the buccal cell samples had significantly more observed species (P < 0.002) and higher alpha diversity (Shannon index, P < 0.02). The microbial communities were more similar (smaller beta diversity) among buccal cells samples than in the other samples (P < 0.001 for 12 of 16 weighted and unweighted UniFrac distance comparisons). Buccal cell microbial profiles closely resembled saliva but were distinct from dental plaque and tongue dorsum. Stored buccal cell samples in prospective cohort studies are a promising resource to study associations of oral microbiota with disease. The feasibility of using existing buccal cell collections in large prospective cohorts allows investigations of the role of oral microbiota in chronic disease etiology in large population studies possible today. Cancer Epidemiol Biomarkers Prev; 26(2); 249-53. ©2016 AACR. ©2016 American Association for Cancer Research.

Using routinely recorded data in the UK to assess outcomes in a randomised controlled trial: The Trials of Access.

PubMed

Powell, G A; Bonnett, L J; Tudur-Smith, C; Hughes, D A; Williamson, P R; Marson, A G

2017-08-23

In the UK, routinely recorded data may benefit prospective studies including randomised controlled trials (RCTs). In an on-going study, we aim to assess the feasibility of access and agreement of routinely recorded clinical and non-clinical data compared to data collected during a RCT using standard prospective methods. This paper will summarise available UK routinely recorded data sources and discuss our experience with the feasibility of accessing routinely recorded data for participants of a RCT before finally proposing recommendations for improving the access and implementation of routinely recorded data in RCTs. Setting: the case study RCT is the Standard and New Antiepileptic Drugs II (SANAD II) trial, a pragmatic, UK, multicentre, phase IV RCT assessing the clinical and cost-effectiveness of antiepileptic drug treatments for newly diagnosed epilepsy. 98 participants have provided written consent to permit the request of routinely recorded data. Study procedures: routinely recorded clinical and non-clinical data were identified and data requested through formal applications from available data holders for the duration that participants have been recruited into SANAD II. The feasibility of accessing routinely recorded data during a RCT is assessed and recommendations for improving access proposed. Secondary-care clinical and socioeconomic data is recorded on a national basis and can be accessed, although there are limitations in the application process. Primary-care data are recorded by a number of organisations on a de-identified basis but access for specific individuals has not been feasible. Access to data recorded by non-clinical sources, including The Department for Work and Pensions and The Driving and Vehicle Licensing Agency, was not successful. Recommendations discussed include further research to assess the attributes of routinely recorded data, an assessment of public perceptions and the development of strategies to collaboratively improve access to routinely recorded data for research. International Standard Randomised Controlled Trials, ISRCTN30294119 . Registered on 3 July 2012. EudraCT No: 2012-001884-64. Registered on 9 May 2012.

Salvage Stereotactic Reirradiation With or Without Cetuximab for Locally Recurrent Head-and-Neck Cancer: A Feasibility Study

DOE Office of Scientific and Technical Information (OSTI.GOV)

Comet, Benedicte; Kramar, Andrew; Faivre-Pierret, Mathieu

2012-09-01

Purpose: Normal tissues tolerance limits the use of reirradiation for recurrent head-and-neck cancers (HNC). Stereotactic body radiotherapy (SBRT) could offer precise irradiation while sparing healthy tissues. Results of a feasibility study using SBRT with or without cetuximab are reported for reirradiation of recurrent primary HNC. Methods and Materials: Patients with inoperable recurrent, or new primary tumor, in a previously irradiated area were included. Reirradiation dose was 36 Gy in six fractions of 6 Gy to the 85% isodose line covering 95% of the planning target volume. Patients with squamous cell carcinoma received concomitant cetuximab. Results: Between June 2007 and Januarymore » 2010, 40 patients were prospectively treated for 43 lesions. Median age was 60 and median tumor size was 29 mm. Fifteen patients received concomitant cetuximab and 1 received concomitant cisplatin. Median follow-up was 25.6 months with 34 patients evaluable for tumor response. Median overall survival was 13.6 months and response rate was 79.4% (15 complete and 12 partial responses). Grade 3 toxicity occurred in 4 patients. Conclusion: These results suggest that short SBRT with or without cetuximab is an effective salvage treatment with good response rate in this poor prognosis population with previously irradiated HNC. Treatment is feasible and, with appropriate care to limiting critical structure, acute toxicities are acceptable. A prospective multicenter Phase II trial of SRT and concomitant cetuximab in recurrent HNC squamous cell carcinoma is ongoing.« less

[Plant hydroponics and its application prospect in medicinal plants study].

PubMed

Zeng, Yan; Guo, Lan-Ping; Huang, Lu-Qi; Sun, Yu-Zhang

2007-03-01

This article introduced the theorem and method of hydroponics. Some examples of studies in agriculture and forestry were presented, the effects of elements, environmental stress and hormones on physiology of medicinal plants by using hydroponics were analyzed. It also introduced the feasibility and advantage of hydroponics in intermediate propagation and allelopathy of medicinal plant. And finally it made the conclusion that the way of hydroponics would be widely used in medicinal plant study.

Feasibility, efficacy, and predictive factors for the technical success of endoscopic nasogallbladder drainage: a prospective study.

PubMed

Yane, Kei; Maguchi, Hiroyuki; Katanuma, Akio; Takahashi, Kuniyuki; Osanai, Manabu; Kin, Toshifumi; Takaki, Ryo; Matsumoto, Kazuyuki; Gon, Katsushige; Matsumori, Tomoaki; Tomonari, Akiko; Nojima, Masanori

2015-03-01

Several studies have shown the useful-ness of endoscopic nasogallbladder drainage (ENGBD) in patients with acute cholecystitis. However, the procedure is difficult, and factors that affect technical success have not yet been clarified. We conducted a prospective study to eval-uate the technical feasibility, efficacy, and predictive factors for the technical success of ENGBD in patients with acute cholecystitis. All patients with moderate or severe acute cholecystitis who were enrolled underwent ENGBD between April 2009 and April 2011. Patients with surgically altered anatomy or pancreatobiliary malignancies were ex-cluded. The primary outcomes included technical success, clinical success, and complications. Factors that could affect the technical success were also examined. Of the 27 patients who underwent ENGBD during the study period, technical success was achieved in 21 (78%) and clinical improvement was achieved in 20 (95%). Early complications were encountered in four patients (15%). Gallbladder wall thickness (odds ratio [OR], 1.64; 95% confidence interval [CI], 1.08 to 2.47) and age (OR, 1.16; 95% CI, 1.00 to 1.35) were effective predictors of technical failure. ENGBD was effective in resolving acute cholecystitis; however, this modality was technically challenging and had a limited suc-cess rate. Because of technical difficulties, ENGBD should be reserved for limited indications. (Gut Liver, 2015;9239-246).

Atrial Fibrillation Screening in Nonmetropolitan Areas Using a Telehealth Surveillance System With an Embedded Cloud-Computing Algorithm: Prospective Pilot Study.

PubMed

Chen, Ying-Hsien; Hung, Chi-Sheng; Huang, Ching-Chang; Hung, Yu-Chien; Hwang, Juey-Jen; Ho, Yi-Lwun

2017-09-26

Atrial fibrillation (AF) is a common form of arrhythmia that is associated with increased risk of stroke and mortality. Detecting AF before the first complication occurs is a recognized priority. No previous studies have examined the feasibility of undertaking AF screening using a telehealth surveillance system with an embedded cloud-computing algorithm; we address this issue in this study. The objective of this study was to evaluate the feasibility of AF screening in nonmetropolitan areas using a telehealth surveillance system with an embedded cloud-computing algorithm. We conducted a prospective AF screening study in a nonmetropolitan area using a single-lead electrocardiogram (ECG) recorder. All ECG measurements were reviewed on the telehealth surveillance system and interpreted by the cloud-computing algorithm and a cardiologist. The process of AF screening was evaluated with a satisfaction questionnaire. Between March 11, 2016 and August 31, 2016, 967 ECGs were recorded from 922 residents in nonmetropolitan areas. A total of 22 (2.4%, 22/922) residents with AF were identified by the physician's ECG interpretation, and only 0.2% (2/967) of ECGs contained significant artifacts. The novel cloud-computing algorithm for AF detection had a sensitivity of 95.5% (95% CI 77.2%-99.9%) and specificity of 97.7% (95% CI 96.5%-98.5%). The overall satisfaction score for the process of AF screening was 92.1%. AF screening in nonmetropolitan areas using a telehealth surveillance system with an embedded cloud-computing algorithm is feasible. ©Ying-Hsien Chen, Chi-Sheng Hung, Ching-Chang Huang, Yu-Chien Hung, Juey-Jen Hwang, Yi-Lwun Ho. Originally published in JMIR Mhealth and Uhealth (http://mhealth.jmir.org), 26.09.2017.

A prospective study of the feasibility and acceptability of a Web-based, electronic patient-reported outcome system in assessing patient recovery after major gynecologic cancer surgery.

PubMed

Andikyan, Vaagn; Rezk, Youssef; Einstein, M Heather; Gualtiere, Gina; Leitao, Mario M; Sonoda, Yukio; Abu-Rustum, Nadeem R; Barakat, Richard R; Basch, Ethan M; Chi, Dennis S

2012-11-01

The purposes of this study are to evaluate the feasibility of capturing patient-reported outcomes (PROs) electronically and to identify the most common distressing symptoms in women recovering from major gynecologic cancer surgery. This was a prospective, single-arm pilot study. Eligible participants included those scheduled for a laparotomy for presumed or known gynecologic malignancy. Patients completed a Web-based "STAR" (Symptom Tracking and Reporting for Patients) questionnaire once preoperatively and weekly during the 6-week postoperative period. The questionnaire consisted of the patient adaptation of the NCI CTCAE 3.0 and EORTC QLQ-C30 3.0. When a patient submitted a response that was concerning, an automated email alert was sent to the clinician. The patient's assessment of STAR's usefulness was measured via an exit survey. Forty-nine patients completed the study. The procedures included the following: hysterectomy±staging (67%), resection of tumor (22%), salpingo-oophorectomy (6%), and other (4%). Most patients (82%) completed at least 4 sessions in STAR. The CTC generated 43 alerts. These alerts resulted in 25 telephone contacts with patients, 2 ER referrals, one new appointment, and one pharmaceutical prescription. The 3 most common patient-reported symptoms generating an alert were as follows: poor performance status (19%), nausea (18%), and fatigue (17%). Most patients found STAR useful (80%) and would recommend it to others (85%). Application of a Web-based, electronic STAR system is feasible in the postoperative period, highly accepted by patients, and warrants further study. Poor performance status, nausea, and fatigue were the most common distressing patient-reported symptoms. Copyright © 2012 Elsevier Inc. All rights reserved.

Electrochemotherapy as treatment option for hepatocellular carcinoma, a prospective pilot study.

PubMed

Djokic, Mihajlo; Cemazar, Maja; Popovic, Peter; Kos, Bor; Dezman, Rok; Bosnjak, Masa; Zakelj, Martina Niksic; Miklavcic, Damijan; Potrc, Stojan; Stabuc, Borut; Tomazic, Ales; Sersa, Gregor; Trotovsek, Blaz

2018-05-01

Electrochemotherapy provides non-thermal ablation of cutaneous as well as deep seated tumors. Based on positive results of the treatment of colorectal liver metastases, we conducted a prospective pilot study on hepatocellular carcinomas with the aim of testing the feasibility, safety and effectiveness of electrochemotherapy. Electrochemotherapy with bleomycin was performed on 17 hepatocellular carcinomas in 10 patients using a previously established protocol. The procedure was performed during open surgery and the patients were followed for median 20.5 months. Electrochemotherapy was feasible for all 17 lesions, and no treatment-related adverse events or major post-operative complications were observed. The median size of the treated lesions was 24 mm (range 8-41 mm), located either centrally, i.e., near the major hepatic vessels, or peripherally. The complete response rate at 3-6 months was 80% per patient and 88% per treated lesion. Electrochemotherapy of hepatocellular carcinoma proved to be a feasible and safe treatment in all 10 patients included in this study. To evaluate the effectiveness of this method, longer observation period is needed; however the results at medium observation time of 20.5 months after treatment are encouraging, in 15 out of 17 lesions complete response was obtained. Electrochemotherapy is predominantly applicable in patients with impaired liver function due to liver cirrhosis and/or with lesions where a high-risk operation is needed to achieve curative intent, given the intra/perioperative risk for high morbidity and mortality. Copyright © 2018 The Author(s). Published by Elsevier Ltd.. All rights reserved.

Cognitive-behavioural treatment for weight loss in primary care: a prospective study.

PubMed

Eichler, Klaus; Zoller, Marco; Steurer, Johann; Bachmann, Lucas M

2007-09-08

Cognitive-behavioural treatment (CBT) is effective for weight loss in obese patients, but such programmes are difficult to implement in primary care. We assessed whether implementation of a community-based CBT weight loss programme for adults in routine care is feasible and prospectively assessed patient outcome. The weight loss programme was provided by a network of Swiss general practitioners in cooperation with a community centre for health education. We chose a five-step strategy focusing on structure of care rather than primarily addressing individual physician behaviour. A multidisciplinary core group of trained CBT instructors acted as the central element of the programme. Overweight and obese adults from the community (BMI >25 kg/m2) were included. We used a patient perspective to report the impact on delivery of care and assessed weight change of consecutive participants prospectively with a follow-up of 12 months. Twenty-eight courses, with 16 group meetings each, were initiated over a period of 3 years. 44 of 110 network physicians referred patients to the programme. 147 of 191 study participants were monitored for one year (attrition rate: 23%). Median weight loss after 12 months for 147 completers was 4 kg (IQR: 1-7 kg; intention-to-treat analysis for 191 participants: 2 kg, IQR: 0-5 kg). The programme produced a clinically meaningful weight loss in our participants, with a relatively low attrition rate. Implementation of an easily accessible CBT programme for weight loss in daily routine primary care is feasible.

Child and adolescent musculoskeletal pain (CAM-Pain) feasibility study: testing a method of identifying, recruiting and collecting data from children and adolescents who consult about a musculoskeletal condition in UK general practice.

PubMed

Michaleff, Zoe A; Campbell, Paul; Hay, Alastair D; Warburton, Louise; Dunn, Kate M

2018-06-14

Test a method of identifying, recruiting and collecting data from children and adolescents who consult their general practitioner about a musculoskeletal condition. Prospective cohort feasibility study. 13 general practices in West Midlands of England. Patients aged 8-19 years who consult their general practice about a musculoskeletal condition. Patients were identified via a relevant musculoskeletal Read code entered at the point of consultation. Feasibility was assessed in terms of study processes (recruitment rates), data collection procedures (duration, response variability), resource utilisation (mail-outs) and ethical considerations (acceptability). From October 2016 to February 2017, an eligible musculoskeletal Read code was entered on 343 occasions, 202 patients were excluded (declined, n=153; screened not suitable, n=49) at the point of consultation. The remaining 141 patients were mailed an invitation to participate (41.1%); 46 patients responded to the invitation (response rate: 32.6%), of which 27 patients consented (consent rate: 19.1%). Participants mean age was 13.7 years (SD 2.7) and current pain intensity was 2.8 (SD 2.7). All participants completed the 6-week follow-up questionnaire. All participants found the interview questions to be acceptable and would consider participating in a similar study in the future. The majority of general practitioners/nurse practitioners, and all of the research nurses reported to be adequately informed about the study and found the study processes acceptable. The expected number of participants were identified and invited, but consent rate was low (<20%) indicating that this method is not feasible (eg, for use in a large prospective study). Recruiting children and adolescents with musculoskeletal conditions in a primary care setting currently presents a challenge for researchers. Further work is needed to identify alternative ways to conduct studies in this population in order to address the current knowledge gap in this field. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

An instrument measuring prospective mathematics teacher self-regulated learning: validity and reliability

NASA Astrophysics Data System (ADS)

Nugroho, A. A.; Juniati, D.; Siswono, T. Y. E.

2018-03-01

Self Regulated Learning (SRL) is an individual's ability to achieve academic goals by controlling behavior, motivate yourself and use cognitive in learning, so it is important for a teacher especially teachers of mathematics related to the ability of management, design, implementation of learning and evaluation of learning outcomes. The purpose of the research is to develop an instrument to describe the SRL of a prospective mathematics teacher. Data were collected by (1) the study of the theory of SRL produced the indicator SRL used to design the questionnaire SRL; (2) analysis of the questionnaire SRL obtained from several References; and (3) development stage of the SRL questionnaire through validity test of content and empirical validation. The study involved 2 content experts in mathematics, 1 linguist, and 92 prospective mathematics teachers. The results of the research on content validity test based on Indonesian expert and 2 content experts indicate that the content can assess the indicator of the SRL and feasible to be used, in the test of legibility of two prospective mathematics teacher concluded that the instrument has a language that can be understood by the prospective teacher of mathematics and on empirical validation involving 92 prospective mathematics teacher generate data that of 65 statements there are 3 invalid statements. Reliability calculation shows high category that values 0,93. The conclusion is the SRL instrument developed for the prospective mathematics teacher.

Real-Time Ultrasound-Guided Spinal Anaesthesia: A Prospective Observational Study of a New Approach

PubMed Central

Conroy, P. H.; Luyet, C.; McCartney, C. J.; McHardy, P. G.

2013-01-01

Identification of the subarachnoid space has traditionally been achieved by either a blind landmark-guided approach or using prepuncture ultrasound assistance. To assess the feasibility of performing spinal anaesthesia under real-time ultrasound guidance in routine clinical practice we conducted a single center prospective observational study among patients undergoing lower limb orthopaedic surgery. A spinal needle was inserted unassisted within the ultrasound transducer imaging plane using a paramedian approach (i.e., the operator held the transducer in one hand and the spinal needle in the other). The primary outcome measure was the success rate of CSF acquisition under real-time ultrasound guidance with CSF being located in 97 out of 100 consecutive patients within median three needle passes (IQR 1–6). CSF was not acquired in three patients. Subsequent attempts combining landmark palpation and pre-puncture ultrasound scanning resulted in successful spinal anaesthesia in two of these patients with the third patient requiring general anaesthesia. Median time from spinal needle insertion until intrathecal injection completion was 1.2 minutes (IQR 0.83–4.1) demonstrating the feasibility of this technique in routine clinical practice. PMID:23365568

A crossover randomized prospective pilot study evaluating a central venous catheter team in reducing catheter-related bloodstream infections in pediatric oncology patients.

PubMed

Secola, Rita; Azen, Colleen; Lewis, Mary Ann; Pike, Nancy; Needleman, Jack; Sposto, Richard; Doering, Lynn

2012-01-01

Treatment for most children with cancer includes the use of a central venous catheter (CVC). CVCs provide reliable venous access for delivery of chemotherapy and supportive care. This advantage is mitigated by an increased risk of bloodstream infections (BSIs). Despite the ubiquitous use of CVCs, few prospective studies have been conducted to address infection prevention strategies in pediatric oncology patients. Prospective, crossover pilot study of a CVC team intervention versus standard care. Two inpatient oncology units in a metropolitan children's hospital. A total of 41 patients/135 admissions for the experimental unit (EU) and 41/129 admissions for the control unit (CU). Patients received a CVC blood draw bundle procedure by a CVC registered nurse (RN) team member (experimental intervention: EU) for 6 months and by the assigned bedside RN (standard care: CU) for 6 months. Feasibility of implementing a CVC RN team; a significant difference in CVC-related BSIs between the team intervention versus standard care and risk factors associated in the development of CVC-related BSIs were determined. There were 7 CVC-related BSIs/1238 catheter days in the EU group (5.7/1000 catheter days) versus 3 CVC-related BSIs/1419 catheter days in the CU group (2.1/1000 catheter days; P = .97). Selected risk factors were not significantly associated with the development of a CVC-related BSI. A CVC team in the care of pediatric oncology patients is feasible; however, a larger cohort will be required to adequately determine the effectiveness of the team reducing CVC-related BSIs.

Robotic Radical Hysterectomy After Concomitant Chemoradiation in Locally Advanced Cervical Cancer: A Prospective Phase II Study.

PubMed

Gallotta, Valerio; Chiantera, Vito; Conte, Carmine; Vizzielli, Giuseppe; Fagotti, Anna; Nero, Camilla; Costantini, Barbara; Lucidi, Alessandro; Cicero, Carla; Scambia, Giovanni; Ferrandina, Gabriella

2017-01-01

To assess the feasibility of total robotic radical surgery (TRRS) in patients with locally advanced cervical cancer (LACC) who receive chemoradiation therapy (CT/RT). A prospective (preplanned) study of a nonrandomized controlled trial (Canadian Task Force classification level 2). Catholic University of the Sacred Hearth, Rome, Italy. Between September 2013 and January 2016, a total of 40 patients with LACC (Fédération Internationale de Gynécologie et d'Obstétrique stage IB2-III) were enrolled in the study. Robotic radical hysterectomy (RRH) plus pelvic and/or aortic lymphadenectomy was attempted within 6 weeks after CT/RT. The feasibility of TRRS as well as the rate, pattern, and severity of early and late postoperative complications were analyzed. After CT/RT, 29 patients (72.5%) underwent type B2 RRH, and 11 (27.5%) underwent type C1 RRH. Pelvic lymphadenectomy was performed in all cases. TRRS was successful in 39 of 40 cases (feasibility rate = 97.5%). In patients successfully completing TRRS, the median operating time was 185 minutes (range, 100-330 minutes), and the median blood loss was 100 mL (range, 50-300 mL). The median time of hospitalization counted from the first postoperative day was 2 days (range, 1-4 days). No intraoperative complications were recorded. During the observation period (median = 18 months; range, 4-28 months), 9 of 40 (22.5%) experienced postoperative complications, for a total number of 12 complications. As of April 2016, recurrence of disease was documented in 5 cases (12.5%). TRRS is feasible in LACC patients administered preoperative CT/RT, providing perioperative outcomes comparable with those registered in early-stage disease, and LACC patients receiving neoadjuvant chemotherapy. Copyright © 2016 AAGL. Published by Elsevier Inc. All rights reserved.

TryCYCLE: A Prospective Study of the Safety and Feasibility of Early In-Bed Cycling in Mechanically Ventilated Patients.

PubMed

Kho, Michelle E; Molloy, Alexander J; Clarke, France J; Ajami, Daana; McCaughan, Magda; Obrovac, Kristy; Murphy, Christina; Camposilvan, Laura; Herridge, Margaret S; Koo, Karen K Y; Rudkowski, Jill; Seely, Andrew J E; Zanni, Jennifer M; Mourtzakis, Marina; Piraino, Thomas; Cook, Deborah J

2016-01-01

The objective of this study was to assess the safety and feasibility of in-bed cycling started within the first 4 days of mechanical ventilation (MV) to inform a future randomized clinical trial. We conducted a 33-patient prospective cohort study in a 21-bed adult academic medical-surgical intensive care unit (ICU) in Hamilton, ON, Canada. We included adult patients (≥ 18 years) receiving MV who walked independently pre-ICU. Our intervention was 30 minutes of in-bed supine cycling 6 days/week in the ICU. Our primary outcome was Safety (termination), measured as events prompting cycling termination; secondary Safety (disconnection or dislodgement) outcomes included catheter/tube dislodgements. Feasibility was measured as consent rate and fidelity to intervention. For our primary outcome, we calculated the binary proportion and 95% confidence interval (CI). From 10/2013-8/2014, we obtained consent from 34 of 37 patients approached (91.9%), 33 of whom received in-bed cycling. Of those who cycled, 16(48.4%) were female, the mean (SD) age was 65.8(12.2) years, and APACHE II score was 24.3(6.7); 29(87.9%) had medical admitting diagnoses. Cycling termination was infrequent (2.0%, 95% CI: 0.8%-4.9%) and no device dislodgements occurred. Cycling began a median [IQR] of 3 [2, 4] days after ICU admission; patients received 5 [3, 8] cycling sessions with a median duration of 30.7 [21.6, 30.8] minutes per session. During 205 total cycling sessions, patients were receiving invasive MV (150 [73.1%]), vasopressors (6 [2.9%]), sedative or analgesic infusions (77 [37.6%]) and dialysis (4 [2.0%]). Early cycling within the first 4 days of MV among hemodynamically stable patients is safe and feasible. Research to evaluate the effect of early cycling on patient function is warranted. Clinicaltrials.gov: NCT01885442.

Safety and feasibility of pulmonary artery pressure-guided heart failure therapy: rationale and design of the prospective CardioMEMS Monitoring Study for Heart Failure (MEMS-HF).

PubMed

Angermann, Christiane E; Assmus, Birgit; Anker, Stefan D; Brachmann, Johannes; Ertl, Georg; Köhler, Friedrich; Rosenkranz, Stephan; Tschöpe, Carsten; Adamson, Philip B; Böhm, Michael

2018-05-19

Wireless monitoring of pulmonary artery (PA) pressures with the CardioMEMS HF™ system is indicated in patients with New York Heart Association (NYHA) class III heart failure (HF). Randomized and observational trials have shown a reduction in HF-related hospitalizations and improved quality of life in patients using this device in the United States. MEMS-HF is a prospective, non-randomized, open-label, multicenter study to characterize safety and feasibility of using remote PA pressure monitoring in a real-world setting in Germany, The Netherlands and Ireland. After informed consent, adult patients with NYHA class III HF and a recent HF-related hospitalization are evaluated for suitability for permanent implantation of a CardioMEMS™ sensor. Participation in MEMS-HF is open to qualifying subjects regardless of left ventricular ejection fraction (LVEF). Patients with reduced ejection fraction must be on stable guideline-directed pharmacotherapy as tolerated. The study will enroll 230 patients in approximately 35 centers. Expected duration is 36 months (24-month enrolment plus ≥ 12-month follow-up). Primary endpoints are freedom from device/system-related complications and freedom from pressure sensor failure at 12-month post-implant. Secondary endpoints include the annualized rate of HF-related hospitalization at 12 months versus the rate over the 12 months preceding implant, and health-related quality of life. Endpoints will be evaluated using data obtained after each subject's 12-month visit. The MEMS-HF study will provide robust evidence on the clinical safety and feasibility of implementing haemodynamic monitoring as a novel disease management tool in routine out-patient care in selected European healthcare systems. ClinicalTrials.gov; NCT02693691.

Efficacy of a novel swallowing exercise program for chronic dysphagia in long-term head and neck cancer survivors.

PubMed

Kraaijenga, Sophie A C; Molen, Lisette van der; Stuiver, Martijn M; Takes, Robert P; Al-Mamgani, Abrahim; Brekel, Michiel W M van den; Hilgers, Frans J M

2017-10-01

The efficacy of rehabilitative exercises for chronic dysphagia treatment in head and neck cancer survivors has not been studied extensively and is ambiguous. A prospective clinical phase II study using an intensive strength training program was carried out in 17 head and neck cancer survivors with chronic dysphagia. Both swallow and nonswallow exercises were performed for 6-8 weeks with a newly developed tool allowing for progressive muscle overload, including chin tuck, jaw opening, and effortful swallow exercises. Outcome parameters were feasibility, compliance, and parameters for effect. Feasibility in terms of the program completion rate was 88%. Compliance with the exercises was 97%. After the training period, chin tuck, jaw opening, and anterior tongue strength had substantially improved. All but 1 patient reported to benefit from the exercises. Feasibility and compliance were high. Some objective and subjective effects of progressive load on muscle strength and swallowing function could be demonstrated. © 2017 Wiley Periodicals, Inc.

Patient transport via private vehicle in Sequoia and Kings Canyon National Parks.

PubMed

Sae, Albert; Haverly, Stephen; Uller, Jeffery; Shalit, Marc; Stroh, Geoff

2005-05-01

Emergency medical service providers frequently encounter patients with low acuity. Because of liability and safety concerns, emergency medical service systems often prohibit privately owned vehicle (POV) transport. Thus, prehospital resources are used with questionable benefit. In Sequoia and Kings Canyon National Parks, our primary objective was to determine the feasibility of POV. We assessed patient compliance, satisfaction, and safety. Our hypothesis was that POV is feasible with online physician medical control. This study was a prospective observational analysis of outcomes from POV during a 1-year period. All POV patients were advised to seek medical attention at a hospital. POV patients were asked questions about their medical complaint and the events during transport and at the hospital. No documented admissions or patient deterioration was noted. During the survey, all patients were either "all better" (86%) or "somewhat better" (14%). We conclude that POV with carefully selected patients and online physician medical control is feasible and deserves further study in other systems.

A double-blind randomized placebo-controlled feasibility study evaluating individualized homeopathy in managing pain of knee osteoarthritis.

PubMed

Koley, Munmun; Saha, Subhranil; Ghosh, Shubhamoy

2015-07-01

Few homeopathic complexes seemed to produce significant effects in osteoarthritis; still, individualized homeopathy remained untested. We evaluated the feasibility of conducting an efficacy trial of individualized homeopathy in osteoarthritis. A prospective, parallel-arm, double-blind, randomized, placebo-controlled pilot study was conducted from January to October 2014 involving 60 patients (homeopathy, n = 30; placebo, n = 30) who were suffering from acute painful episodes of knee osteoarthritis and visiting the outpatient clinic of Mahesh Bhattacharyya Homeopathic Medical College and Hospital, West Bengal, India. Statistically significant reduction was achieved in 3 visual analog scales (measuring pain, stiffness, and loss of function) and Osteoarthritis Research Society International scores in both groups over 2 weeks (P < .05); however, group differences were not significant (P > .05). Overall, homeopathy did not appear to be superior to placebo; still, further rigorous evaluation in this design involving a larger sample size seems feasible in future. Clinical Trials Registry, India (CTRI/2014/05/004589). © The Author(s) 2015.

Haematopoietic SCT in severe autoimmune diseases: updated guidelines of the European Group for Blood and Marrow Transplantation

PubMed Central

Snowden, J A; Saccardi, R; Allez, M; Ardizzone, S; Arnold, R; Cervera, R; Denton, C; Hawkey, C; Labopin, M; Mancardi, G; Martin, R; Moore, J J; Passweg, J; Peters, C; Rabusin, M; Rovira, M; van Laar, J M; Farge, D

2012-01-01

In 1997, the first consensus guidelines for haematopoietic SCT (HSCT) in autoimmune diseases (ADs) were published, while an international coordinated clinical programme was launched. These guidelines provided broad principles for the field over the following decade and were accompanied by comprehensive data collection in the European Group for Blood and Marrow Transplantation (EBMT) AD Registry. Subsequently, retrospective analyses and prospective phase I/II studies generated evidence to support the feasibility, safety and efficacy of HSCT in several types of severe, treatment-resistant ADs, which became the basis for larger-scale phase II and III studies. In parallel, there has also been an era of immense progress in biological therapy in ADs. The aim of this document is to provide revised and updated guidelines for both the current application and future development of HSCT in ADs in relation to the benefits, risks and health economic considerations of other modern treatments. Patient safety considerations are central to guidance on patient selection and HSCT procedural aspects within appropriately experienced and Joint Accreditation Committee of International Society for Cellular Therapy and EBMT accredited centres. A need for prospective interventional and non-interventional studies, where feasible, along with systematic data reporting, in accordance with EBMT policies and procedures, is emphasized. PMID:22002489

Automated tru-cut imaging-guided core needle biopsy of canine orbital neoplasia. A prospective feasibility study

PubMed Central

Cirla, A.; Rondena, M.; Bertolini, G.

2016-01-01

The purpose of this study was to evaluate the diagnostic value of imaging-guided core needle biopsy for canine orbital mass diagnosis. A second excisional biopsy obtained during surgery or necropsy was used as the reference standard. A prospective feasibility study was conducted in 23 canine orbital masses at a single centre. A complete ophthalmic examination was always followed by orbital ultrasound and computed tomography (CT) examination of the head. All masses were sampled with the patient still on the CT table using ultrasound (US) guided automatic tru-cut device. The most suitable sampling approach to the orbit was chosen each time based on the CT image analysis. One of the following different approaches was used: trans-orbital, trans-conjunctival or trans-masseteric. In all cases, the imaging-guided biopsy provided a sufficient amount of tissue for the histopathological diagnosis, which concurred with the biopsies obtained using the excisional technique. CT examination was essential for morphological diagnosis and provided detailed topographic information that allowed us to choose the safest orbital approach for the biopsy. US guided automatic tru-cut biopsy based on CT images, performed with patient still on the CT table, resulted in a minimally invasive, relatively easy, and accurate diagnostic procedure in dogs with orbital masses. PMID:27540512

Automated tru-cut imaging-guided core needle biopsy of canine orbital neoplasia. A prospective feasibility study.

PubMed

Cirla, A; Rondena, M; Bertolini, G

2016-01-01

The purpose of this study was to evaluate the diagnostic value of imaging-guided core needle biopsy for canine orbital mass diagnosis. A second excisional biopsy obtained during surgery or necropsy was used as the reference standard. A prospective feasibility study was conducted in 23 canine orbital masses at a single centre. A complete ophthalmic examination was always followed by orbital ultrasound and computed tomography (CT) examination of the head. All masses were sampled with the patient still on the CT table using ultrasound (US) guided automatic tru-cut device. The most suitable sampling approach to the orbit was chosen each time based on the CT image analysis. One of the following different approaches was used: trans-orbital, trans-conjunctival or trans-masseteric. In all cases, the imaging-guided biopsy provided a sufficient amount of tissue for the histopathological diagnosis, which concurred with the biopsies obtained using the excisional technique. CT examination was essential for morphological diagnosis and provided detailed topographic information that allowed us to choose the safest orbital approach for the biopsy. US guided automatic tru-cut biopsy based on CT images, performed with patient still on the CT table, resulted in a minimally invasive, relatively easy, and accurate diagnostic procedure in dogs with orbital masses.

Standardized laparoscopic NOSE-colectomy is feasible with low morbidity.

PubMed

Wolthuis, Albert M; de Buck van Overstraeten, Anthony; Fieuws, Steffen; Boon, Katrien; D'Hoore, André

2015-05-01

In laparoscopic colorectal surgery, extraction site laparotomy can be avoided by natural orifice specimen extraction (NOSE) resulting in less postoperative pain, shorter length of stay, and less morbidity such as wound complications. To date, short-term outcome of a large prospective cohort of patients has not been studied. The aim of this prospective cohort study was to assess short-term outcome of laparoscopic left-sided NOSE-colectomy. Prospectively collected data of patients who had undergone elective laparoscopic NOSE-colectomy between July 2009 and December 2013 were analyzed retrospectively. Primary endpoint was short-term morbidity. A total of 110 patients were included in this study. Median age was 38 years (IQR: 32-56), median BMI was 23 kg/m(2) (IQR: 21-25), and 88% of the patients were female. Sixty-three patients (57%) underwent resection for endometriosis, 29 patients (26%) for diverticular disease, 16 patients (15%) for a tumor, and 2 patients for other indications. Median operating time was 85 min (IQR: 70-100) and median length of the extracted specimen was 20 cm (IQR: 16-25). Overall, 14 patients had a postoperative complication (13%), of which 9 were Clavien-Dindo grade 1 or 2 (8%). Four patients (3.6%) had an intraluminal bleeding from the anastomosis, which was treated endoscopically. There was 1 anastomotic leak (1%), treated by emergency laparotomy and creation of a new colorectal anastomosis (grade 3b). The median hospital stay was 5 days (IQR: 4-6). Laparoscopic NOSE-colectomy is safe and feasible with good short-term outcome. This study concerning a standardized operative technique is the first in literature reporting on a large group of patients.

Feasibility of conducting prospective observational research on critically ill, dying patients in the intensive care unit.

PubMed

van Beinum, Amanda; Hornby, Laura; Dhanani, Sonny; Ward, Roxanne; Chambers-Evans, Jane; Menon, Kusum

2017-01-01

Studying patients during the end of life is important, as it has the potential to lead to improvements in care for the dying. For patients who die after a controlled withdrawal of life-sustaining therapies in the intensive care unit, information about the natural history of death and the process of removing life support has additionally led to advances in practice for deceased organ donation. However, this unique population of severely critically ill and imminently dying patients has been difficult to study, largely due to assumptions made by research teams and ethics boards alike about the logistical difficulties of obtaining consent and completing research procedures before or during the process of withdrawal of life-sustaining therapies. In this paper, we describe the ethics substudy of the first prospective observational research study in Canada to obtain consent and collect clinical data on patients during the process of withdrawal of life-sustaining therapies in the intensive care unit. We describe in detail the process of protocol development, review by five institutional research ethics boards and bedside staff satisfaction with the study. We conclude that prospective research on a critically ill and imminently dying population is feasible and can be conducted in an ethical manner. Further information is needed about the experiences and motivations of families and substitute decision makers who provide consent for research on critically ill intensive care unit patients at the end of life. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.

Probiotics: Prevention of Severe Pneumonia and Endotracheal Colonization Trial-PROSPECT: a pilot trial.

PubMed

Cook, Deborah J; Johnstone, Jennie; Marshall, John C; Lauzier, Francois; Thabane, Lehana; Mehta, Sangeeta; Dodek, Peter M; McIntyre, Lauralyn; Pagliarello, Joe; Henderson, William; Taylor, Robert W; Cartin-Ceba, Rodrigo; Golan, Eyal; Herridge, Margaret; Wood, Gordon; Ovakim, Daniel; Karachi, Tim; Surette, Michael G; Bowdish, Dawn M E; Lamarche, Daphnee; Verschoor, Chris P; Duan, Erick H; Heels-Ansdell, Diane; Arabi, Yaseen; Meade, Maureen

2016-08-02

Probiotics are live microorganisms that may confer health benefits when ingested. Randomized trials suggest that probiotics significantly decrease the incidence of ventilator-associated pneumonia (VAP) and the overall incidence of infection in critically ill patients. However, these studies are small, largely single-center, and at risk of bias. The aim of the PROSPECT pilot trial was to determine the feasibility of conducting a larger trial of probiotics to prevent VAP in mechanically ventilated patients in the intensive care unit (ICU). In a randomized blinded trial, patients expected to be mechanically ventilated for ≥72 hours were allocated to receive either 1 × 10(10) colony-forming units of Lactobacillus rhamnosus GG or placebo, twice daily. Patients were excluded if they were at increased risk of L. rhamnosus GG infection or had contraindications to enteral medication. Feasibility objectives were: (1) timely recruitment; (2) maximal protocol adherence; (3) minimal contamination; and (4) estimated VAP rate ≥10 %. We also measured other infections, diarrhea, ICU and hospital length of stay, and mortality. Overall, in 14 centers in Canada and the USA, all feasibility goals were met: (1) 150 patients were randomized in 1 year; (2) protocol adherence was 97 %; (3) no patients received open-label probiotics; and (4) the VAP rate was 19 %. Other infections included: bloodstream infection (19.3 %), urinary tract infections (12.7 %), and skin and soft tissue infections (4.0 %). Diarrhea, defined as Bristol type 6 or 7 stools, occurred in 133 (88.7 %) of patients, the median length of stay in ICU was 12 days (quartile 1 to quartile 3, 7-18 days), and in hospital was 26 days (quartile 1 to quartile 3, 14-44 days); 23 patients (15.3 %) died in the ICU. The PROSPECT pilot trial supports the feasibility of a larger trial to investigate the effect of L. rhamnosus GG on VAP and other nosocomial infections in critically ill patients. Clinicaltrials.gov NCT01782755 . Registered on 29 January 2013.

The UAE healthy future study: a pilot for a prospective cohort study of 20,000 United Arab Emirates nationals.

PubMed

Abdulle, Abdishakur; Alnaeemi, Abdullah; Aljunaibi, Abdullah; Al Ali, Abdulrahman; Al Saedi, Khaled; Al Zaabi, Eiman; Oumeziane, Naima; Al Bastaki, Marina; Al-Houqani, Mohammed; Al Maskari, Fatma; Al Dhaheri, Ayesha; Shah, Syed M; Loney, Tom; El-Sadig, Mohamed; Oulhaj, Abderrahim; Wareth, Leila Abdel; Al Mahmeed, Wael; Alsafar, Habiba; Hirsch, Benjamin; Al Anouti, Fatme; Yaaqoub, Jamila; Inman, Claire K; Al Hamiz, Aisha; Al Hosani, Ayesha; Haji, Muna; Alsharid, Teeb; Al Zaabi, Thekra; Al Maisary, Fatima; Galani, Divya; Sprosen, Tim; El Shahawy, Omar; Ahn, Jiyoung; Kirchhoff, Tomas; Ramasamy, Ravichandran; Schmidt, Ann Marie; Hayes, Richard; Sherman, Scott; Ali, Raghib

2018-01-05

The United Arab Emirates (UAE) is faced with a rapidly increasing burden of non-communicable diseases including obesity, diabetes, and cardiovascular disease. The UAE Healthy Future study is a prospective cohort designed to identify associations between risk factors and these diseases amongst Emiratis. The study will enroll 20,000 UAE nationals aged ≥18 years. Environmental and genetic risk factors will be characterized and participants will be followed for future disease events. As this was the first time a prospective cohort study was being planned in the UAE, a pilot study was conducted in 2015 with the primary aim of establishing the feasibility of conducting the study. Other objectives were to evaluate the implementation of the main study protocols, and to build adequate capacity to conduct advanced clinical laboratory analyses. Seven hundred sixty nine UAE nationals aged ≥18 years were invited to participate voluntarily in the pilot study. Participants signed an informed consent, completed a detailed questionnaire, provided random blood, urine, and mouthwash samples and were assessed for a series of clinical measures. All specimens were transported to the New York University Abu Dhabi laboratories where samples were processed and analyzed for routine chemistry and hematology. Plasma, serum, and a small whole blood sample for DNA extraction were aliquoted and stored at -80 °C for future analyses. Overall, 517 Emirati men and women agreed to participate (68% response rate). Of the total participants, 495 (95.0%), 430 (82.2%), and 492 (94.4%), completed the questionnaire, physical measurements, and provided biological samples, respectively. The pilot study demonstrated the feasibility of recruitment and completion of the study protocols for the first large-scale cohort study designed to identify emerging risk factors for the major non-communicable diseases in the region.

A cost and returns evaluation of alternative dairy products to determine capital investment and operational feasibility of a small-scale dairy processing facility.

PubMed

Becker, K M; Parsons, R L; Kolodinsky, J; Matiru, G N

2007-05-01

This study examines the economic feasibility of 50- and 500-cow dairy processing facilities for fluid milk, yogurt, and cheese. Net present value and internal rate of return calculations for projected costs and returns over a 10-yr period indicate that larger yogurt and cheese processing plants offer the most profitable prospects, whereas a smaller yogurt plant would break even. A smaller cheese plant would have insufficient returns to cover the cost of capital, and fluid milk processing at either scale is economically infeasible. Economic success in processing is greatly contingent upon individual business, financial management, and marketing skills.

A Dual-Beam Irradiation Facility for a Novel Hybrid Cancer Therapy

NASA Astrophysics Data System (ADS)

Sabchevski, Svilen Petrov; Idehara, Toshitaka; Ishiyama, Shintaro; Miyoshi, Norio; Tatsukawa, Toshiaki

2013-01-01

In this paper we present the main ideas and discuss both the feasibility and the conceptual design of a novel hybrid technique and equipment for an experimental cancer therapy based on the simultaneous and/or sequential application of two beams, namely a beam of neutrons and a CW (continuous wave) or intermittent sub-terahertz wave beam produced by a gyrotron for treatment of cancerous tumors. The main simulation tools for the development of the computer aided design (CAD) of the prospective experimental facility for clinical trials and study of such new medical technology are briefly reviewed. Some tasks for a further continuation of this feasibility analysis are formulated as well.

Testing the Feasibility of Remote Patient Monitoring in Prenatal Care Using a Mobile App and Connected Devices: A Prospective Observational Trial.

PubMed

Marko, Kathryn I; Krapf, Jill M; Meltzer, Andrew C; Oh, Julia; Ganju, Nihar; Martinez, Anjali G; Sheth, Sheetal G; Gaba, Nancy D

2016-11-18

Excessive weight gain and elevated blood pressure are significant risk factors for adverse pregnancy outcomes such as gestational diabetes, premature birth, and preeclampsia. More effective strategies to facilitate adherence to gestational weight gain goals and monitor blood pressure may have a positive health benefit for pregnant women and their babies. The impact of utilizing a remote patient monitoring system to monitor blood pressure and weight gain as a component of prenatal care has not been previously assessed. The objective of this study is to determine the feasibility of monitoring patients remotely in prenatal care using a mobile phone app and connected digital devices. In this prospective observational study, 8 women with low risk pregnancy in the first trimester were recruited at an urban academic medical center. Participants received a mobile phone app with a connected digital weight scale and blood pressure cuff for at-home data collection for the duration of pregnancy. At-home data was assessed for abnormal values of blood pressure or weight to generate clinical alerts to the patient and provider. As measures of the feasibility of the system, participants were studied for engagement with the app, accuracy of remote data, efficacy of alert system, and patient satisfaction. Patient engagement with the mobile app averaged 5.5 times per week over the 6-month study period. Weight data collection and blood pressure data collection averaged 1.5 times and 1.1 times per week, respectively. At-home measurements of weight and blood pressure were highly accurate compared to in-office measurements. Automatic clinical alerts identified two episodes of abnormal weight gain with no false triggers. Patients demonstrated high satisfaction with the system. In this pilot study, we demonstrated that a system using a mobile phone app coupled to remote monitoring devices is feasible for prenatal care. ©Kathryn I Marko, Jill M Krapf, Andrew C Meltzer, Julia Oh, Nihar Ganju, Anjali G Martinez, Sheetal G Sheth, Nancy D Gaba. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 18.11.2016.

Determination of feasibility and utility of microscope-integrated optical coherence tomography during ophthalmic surgery: the DISCOVER Study RESCAN Results.

PubMed

Ehlers, Justis P; Goshe, Jeff; Dupps, William J; Kaiser, Peter K; Singh, Rishi P; Gans, Richard; Eisengart, Jonathan; Srivastava, Sunil K

2015-10-01

Optical coherence tomography (OCT) has transformed the clinical management of a myriad of ophthalmic conditions. Applying OCT to ophthalmic surgery may have implications for surgical decision making and patient outcomes. To assess the feasibility and effect on surgical decision making of a microscope-integrated intraoperative OCT (iOCT) system. Report highlighting the 1-year results (March 2014-February 2015) of the RESCAN 700 portion of the DISCOVER (Determination of Feasibility of Intraoperative Spectral Domain Microscope Combined/Integrated OCT Visualization During En Face Retinal and Ophthalmic Surgery) study, a single-site, multisurgeon, prospective consecutive case series regarding this investigational device. Participants included patients undergoing ophthalmic surgery. Data on clinical characteristics were collected, and iOCT was performed during surgical milestones, as directed by the operating surgeon. A surgeon questionnaire was issued to each surgeon and was completed after each case to evaluate the role of iOCT during surgery and its particular role in select surgical procedures. Percentage of cases with successful acquisition of iOCT (ie, feasibility). Percentage of cases in which iOCT altered surgical decision making (ie, utility). During year 1 of the DISCOVER study, a total of 227 eyes (91 anterior segment cases and 136 posterior segment cases) underwent imaging with the RESCAN 700 system. Successful imaging (eg, the ability to acquire an OCT image of the tissue of interest) was obtained for 224 of 227 eyes (99% [95% CI, 98%-100%]). During lamellar keratoplasty, the iOCT data provided information that altered the surgeon's decision making in 38% of the cases (eg, complete graft apposition when the surgeon believed there was interface fluid). In membrane peeling procedures, iOCT information was discordant with the surgeon's impression of membrane peel completeness in 19% of cases (eg, lack of residual membrane or presence of occult membrane), thus affecting additional surgical maneuvers. The DISCOVER study demonstrates the feasibility of real-time iOCT with a microscope-integrated iOCT system for ophthalmic surgery. The information gained from iOCT appears to allow surgeons to assess subtle details in a unique perspective from standard en face visualization, which can affect surgical decision making some of the time, although the effect of these changes in decision making on outcomes remains unknown. A prospective randomized masked trial is needed to confirm these results.

Prospective cohort study of a new vacuum delivery device to assist with complicated labour in low-resource settings.

PubMed

Khan, Mishal; Hashmani, Farah Naz; Ahmed, Sajjad; Ahmed, Owais; Asim, Shabnam S; Wajahat, Yasmin; Sobani, Shoaib; Syed, Shershah; Qazi, Fahad

2015-02-01

Currently available vacuum devices used to assist women undergoing complicated labour are unsuitable for use in low-resource settings. The objective of this study was to evaluate the safety and feasibility of a new low-cost vacuum device, named Koohi Goth Vacuum Delivery System (KGVDS), designed for use in low-resource settings. A hospital-based, multicentre, prospective cohort study with no control group was conducted in Karachi, Pakistan. After training, KGVDS devices were made available for use by labour room staff at their discretion when instrumental delivery was indicated. Women to whom KGVDS was applied were followed from the start of labour until discharge. Feasibility was assessed in terms of successful expulsion of the foetal head following application of KGVDS and ease of use ratings. Safety was assessed by observing maternal and newborn post-delivery outcomes prior to discharge. Koohi Goth Vacuum Delivery System was applied to 137 women requiring instrumental delivery, of whom 111 (81%; 95% CI = 74-88%) successfully expelled the foetal head assisted by KGVDS and 103 (75%) stated that they would agree to use KGVDS again. There were no serious maternal or neonatal injuries or infections related to KGVDS use. The mean score for 'ease of use' given by doctors and midwives using the device was 8 of 10. Koohi Goth Vacuum Delivery System was feasible and safe to use for assisting complicated deliveries in low-resource hospitals in this initial evaluation. Our results indicate that this new device may have the potential to improve birth outcomes in settings where most mortality occurs and that further evaluations should be conducted. © 2014 John Wiley & Sons Ltd.

Role of MRA in the detection of intracranial aneurysm in the acute phase of subarachnoid hemorrhage.

PubMed

Pierot, Laurent; Portefaix, Christophe; Rodriguez-Régent, Christine; Gallas, Sophie; Meder, Jean-François; Oppenheim, Catherine

2013-07-01

Magnetic resonance angiography (MRA) has been evaluated for the detection of unruptured intracranial aneurysms with favorable results at 3 Tesla (3T) and with similar diagnostic accuracy as both 3D time-of-flight (3D-TOF) and contrast-enhanced (CE-MRA) MRA. However, the diagnostic value and place of MRA in the detection of ruptured aneurysms has been little evaluated. Thus, the goal of this prospective single-center series was to assess the feasibility and diagnostic value of 3T 3D-TOF MRA and CE-MRA for aneurysm detection in acute non-traumatic subarachnoid hemorrhage (SAH). From March 2006 to December 2007, all consecutive patients admitted to our hospital with acute non-traumatic SAH (≤10 days) were prospectively included in this study evaluating MRA in the diagnostic workup of SAH. Feasibility of MRA and sensitivity/specificity of 3D-TOF and CE-MRA were assessed compared with gold standard DSA. In all, 84 consecutive patients (45 women, 39 men; age 23-86 years) were included. The feasibility of MRA was low (43/84, 51.2%). The reasons given for patients not undergoing magnetic resonance imaging (MRI) examination were clinical status (27 patients), potential delay in aneurysm treatment (11 patients) and contraindications to MRI (three patients). In patients explored by MRA, the sensitivity of CE-MRA (95%) was higher compared with 3D-TOF (86%) with similar specificity (80%). Also, 3D-TOF missed five aneurysms while CE-MRA missed two. The value of MRA in the diagnostic workup of ruptured aneurysms is limited due to its low feasibility during the acute phase of bleeding. Sensitivity for aneurysm detection was good for both MRA techniques, but tended to be better with CE-MRA. Copyright © 2013. Published by Elsevier Masson SAS.

Non-invasive, home-based electroencephalography hypoglycaemia warning system for personal monitoring using skin surface electrodes: a single-case feasibility study.

PubMed

Clewett, Christopher J; Langley, Phillip; Bateson, Anthony D; Asghar, Aziz; Wilkinson, Antony J

2016-03-01

Hypoglycaemia unawareness is a common condition associated with increased risk of severe hypoglycaemia. The purpose of the authors' study was to develop a simple to use, home-based and non-invasive hypoglycaemia warning system based on electroencephalography (EEG), and to demonstrate its use in a single-case feasibility study. A participant with type 1 diabetes forms a single-person case study where blood sugar levels and EEG were recorded. EEG was recorded using skin surface electrodes placed behind the ear located within the T3 region by the participant in the home. EEG was analysed retrospectively to develop an algorithm which would trigger a warning if EEG changes associated with hypoglycaemia onset were detected. All hypoglycaemia events were detected by the EEG hypoglycaemia warning algorithm. Warnings were triggered with blood glucose concentration levels at or below 4.2 mmol/l in this participant and no warnings were issued when in euglycaemia. The feasibility of a non-invasive EEG-based hypoglycaemia warning system for personal monitoring in the home has been demonstrated in a single case study. The results suggest that further studies are warranted to evaluate the system prospectively in a larger group of participants.

Evaluating Integrative Cancer Clinics With the Claim Assessment Profile: An Example With the InspireHealth Clinic

PubMed Central

Hilton, Lara; Elfenbaum, Pamela; Jain, Shamini; Sprengel, Meredith; Jonas, Wayne B.

2016-01-01

Background: The evaluation of freestanding integrative cancer clinical programs is challenging and is rarely done. We have developed an approach called the Claim Assessment Profile (CAP) to identify whether evaluation of a practice is justified, feasible, and likely to provide useful information. Objectives: A CAP was performed in order to (1) clarify the healing claims at InspireHealth, an integrative oncology treatment program, by defining the most important impacts on its clients; (2) gather information about current research capacity at the clinic; and (3) create a program theory and path model for use in prospective research. Study Design/Methods: This case study design incorporates methods from a variety of rapid assessment approaches. Procedures included site visits to observe the program, structured qualitative interviews with 26 providers and staff, surveys to capture descriptive data about the program, and observational data on program implementation. Results: The InspireHealth program is a well-established, multi-site, thriving integrative oncology clinical practice that focuses on patient support, motivation, and health behavior engagement. It delivers patient-centered care via a standardized treatment protocol. There arehigh levels of research interest from staff and resources by which to conduct research. Conclusions: This analysis provides the primary descriptive and claims clarification of an integrative oncology treatment program, an evaluation readiness report, a detailed logic model explicating program theory, and a clinical outcomes path model for conducting prospective research. Prospective evaluation of this program would be feasible and valuable, adding to our knowledge base of integrative cancer therapies. PMID:29444602

Feasibility of task-specific brain-machine interface training for upper-extremity paralysis in patients with chronic hemiparetic stroke.

PubMed

Nishimoto, Atsuko; Kawakami, Michiyuki; Fujiwara, Toshiyuki; Hiramoto, Miho; Honaga, Kaoru; Abe, Kaoru; Mizuno, Katsuhiro; Ushiba, Junichi; Liu, Meigen

2018-01-10

Brain-machine interface training was developed for upper-extremity rehabilitation for patients with severe hemiparesis. Its clinical application, however, has been limited because of its lack of feasibility in real-world rehabilitation settings. We developed a new compact task-specific brain-machine interface system that enables task-specific training, including reach-and-grasp tasks, and studied its clinical feasibility and effectiveness for upper-extremity motor paralysis in patients with stroke. Prospective beforeâ€"after study. Twenty-six patients with severe chronic hemiparetic stroke. Participants were trained with the brain-machine interface system to pick up and release pegs during 40-min sessions and 40 min of standard occupational therapy per day for 10 days. Fugl-Meyer upper-extremity motor (FMA) and Motor Activity Log-14 amount of use (MAL-AOU) scores were assessed before and after the intervention. To test its feasibility, 4 occupational therapists who operated the system for the first time assessed it with the Quebec User Evaluation of Satisfaction with assistive Technology (QUEST) 2.0. FMA and MAL-AOU scores improved significantly after brain-machine interface training, with the effect sizes being medium and large, respectively (p<0.01, d=0.55; p<0.01, d=0.88). QUEST effectiveness and safety scores showed feasibility and satisfaction in the clinical setting. Our newly developed compact brain-machine interface system is feasible for use in real-world clinical settings.

Feasibility of implementation of a "simplified, No-X-Ray, no-lead apron, two-catheter approach" for ablation of supraventricular arrhythmias in children and adults.

PubMed

Stec, Sebastian; Śledź, Janusz; Mazij, Mariusz; Raś, Małgorzata; Ludwik, Bartosz; Chrabąszcz, Michał; Śledź, Arkadiusz; Banasik, Małgorzata; Bzymek, Magdalena; Młynarczyk, Krzysztof; Deutsch, Karol; Labus, Michał; Śpikowski, Jerzy; Szydłowski, Lesław

2014-08-01

Although the "near-zero-X-Ray" or "No-X-Ray" catheter ablation (CA) approach has been reported for treatment of various arrhythmias, few prospective studies have strictly used "No-X-Ray," simplified 2-catheter approaches for CA in patients with supraventricular tachycardia (SVT). We assessed the feasibility of a minimally invasive, nonfluoroscopic (MINI) CA approach in such patients. Data were obtained from a prospective multicenter CA registry of patients with regular SVTs. After femoral access, 2 catheters were used to create simple, 3D electroanatomic maps and to perform electrophysiologic studies. Medical staff did not use lead aprons after the first 10 MINI CA cases. A total of 188 patients (age, 45 ± 21 years; 17% <19 years; 55% women) referred for the No-X-Ray approach were included. They were compared to 714 consecutive patients referred for a simplified approach using X-rays (age, 52 ± 18 years; 7% <19 years; 55% women). There were 9 protocol exceptions that necessitated the use of X-rays. Ultimately, 179/188 patients underwent the procedure without fluoroscopy, with an acute success rate of 98%. The procedure times (63 ± 26 vs. 63 ± 29 minutes, P > 0.05), major complications (0% vs. 0%, P > 0.05) and acute (98% vs. 98%, P > 0.05) and long-term (93% vs. 94%, P > 0.05) success rates were similar in the "No-X-Ray" and control groups. Implementation of a strict "No-X-Ray, simplified 2-catheter" CA approach is safe and effective in majority of the patients with SVT. This modified approach for SVTs should be prospectively validated in a multicenter study. © 2014 Wiley Periodicals, Inc.

Ictal and interictal electric source imaging in presurgical evaluation: a prospective study.

PubMed

Sharma, Praveen; Scherg, Michael; Pinborg, Lars H; Fabricius, Martin; Rubboli, Guido; Pedersen, Birthe; Leffers, Anne-Mette; Uldall, Peter; Jespersen, Bo; Brennum, Jannick; Mølby Henriksen, Otto; Beniczky, Sándor

2018-05-11

Accurate localization of the epileptic focus is essential for surgical treatment of patients with drug- resistant epilepsy. EEG source imaging (ESI) is increasingly used in presurgical evaluation. However, most previous studies analysed interictal discharges. Prospective studies comparing feasibility and accuracy of interictal (II) and ictal (IC) ESI are lacking. We prospectively analysed long-term video EEG recordings (LTM) of patients admitted for presurgical evaluation. We performed ESI of II and IC signals, using two methods: equivalent current dipole (ECD) and distributed source model (DSM). LTM recordings employed the standard 25-electrode array (including inferior temporal electrodes). An age-matched template head-model was used for source analysis. Results were compared with intracranial recordings (ICR), conventional neuroimaging methods (MRI, PET, SPECT) and outcome one year after surgery. Eighty-seven consecutive patients were analysed. ECD gave a significantly higher proportion of patients with localised focal abnormalities (94%) compared to MRI (70%), PET (66%) and SPECT (64%). Agreement between the ESI methods and ICR was moderate to substantial (k=0.56-0.79). Fifty-four patients were operated (47 for more than one year ago) and 62% of them became seizure-free. Localization accuracy of II-ESI was 51% for DSM and 57% for ECD; for IC-ESI this was 51% (DSM) and 62% (ECD). The differences between the ESI methods were not significant. Differences in localization accuracy between ESI and MRI (55%), PET (33%) and SPECT (40%) were not significant. II and IC ESI of LTM-data have high feasibility and their localisation accuracy is similar to the conventional neuroimaging methods. This article is protected by copyright. All rights reserved. This article is protected by copyright. All rights reserved.

Coordination and management of multicenter clinical studies in trauma: Experience from the PRospective Observational Multicenter Major Trauma Transfusion (PROMMTT) Study.

PubMed

Rahbar, Mohammad H; Fox, Erin E; del Junco, Deborah J; Cotton, Bryan A; Podbielski, Jeanette M; Matijevic, Nena; Cohen, Mitchell J; Schreiber, Martin A; Zhang, Jiajie; Mirhaji, Parsa; Duran, Sarah J; Reynolds, Robert J; Benjamin-Garner, Ruby; Holcomb, John B

2012-04-01

Early death due to hemorrhage is a major consequence of traumatic injury. Transfusion practices differ among hospitals and it is unknown which transfusion practices improve survival. This report describes the experience of the PRospective Observational Multicenter Major Trauma Transfusion (PROMMTT) Study Data Coordination Center in designing and coordinating a study to examine transfusion practices at ten Level 1 trauma centers in the US. PROMMTT was a multisite prospective observational study of severely injured transfused trauma patients. The clinical sites collected real-time information on the timing and amounts of blood product infusions as well as colloids and crystalloids, vital signs, initial diagnostic and clinical laboratory tests, life saving interventions and other clinical care data. Between July 2009 and October 2010, PROMMTT screened 12,561 trauma admissions and enrolled 1245 patients who received one or more blood transfusions within 6h of Emergency Department (ED) admission. A total of 297 massive transfusions were observed over the course of the study at a combined rate of 5.0 massive transfusion patients/week. PROMMTT is the first multisite study to collect real-time prospective data on trauma patients requiring transfusion. Support from the Department of Defense and collaborative expertise from the ten participating centers helped to demonstrate the feasibility of prospective trauma transfusion studies. The observational data collected from this study will be an invaluable resource for research in trauma surgery and it will guide the design and conduct of future randomized trials. Copyright © 2011 Elsevier Ireland Ltd. All rights reserved.

Coordination and management of multicenter clinical studies in trauma: Experience from the PRospective Observational Multicenter Major Trauma Transfusion (PROMMTT) Study

PubMed Central

Rahbar, Mohammad H.; Fox, Erin E.; del Junco, Deborah J.; Cotton, Bryan A.; Podbielski, Jeanette M.; Matijevic, Nena; Cohen, Mitchell J.; Schreiber, Martin A.; Zhang, Jiajie; Mirhaji, Parsa; Duran, Sarah; Reynolds, Robert J.; Benjamin-Garner, Ruby; Holcomb, John B.

2011-01-01

Aim Early death due to hemorrhage is a major consequence of traumatic injury. Transfusion practices differ among hospitals and it is unknown which transfusion practices improve survival. This report describes the experience of the PRospective Observational Multicenter Major Trauma Transfusion (PROMMTT) Study Data Coordination Center in designing and coordinating a study to examine transfusion practices at ten Level 1 trauma centers in the U.S. Methods PROMMTT was a multisite prospective observational study of severely injured transfused trauma patients. The clinical sites collected real-time information on the timing and amounts of blood product infusions as well as colloids and crystalloids, vital signs, initial diagnostic and clinical laboratory tests, life saving interventions and other clinical care data. Results Between July 2009 and October 2010, PROMMTT screened 12,561 trauma admissions and enrolled 1,245 patients who received one or more blood transfusions within 6 hours of ED admission. A total of 297 massive transfusions were observed over the course of the study at a combined rate of 5.0 massive transfusion patients/week. Conclusion PROMMTT is the first multisite study to collect real-time prospective data on trauma patients requiring transfusion. Support from the Department of Defense and collaborative expertise from the ten participating centers helped to demonstrate the feasibility of prospective trauma transfusion studies. The observational data collected from this study will be an invaluable resource for research in trauma surgery and it will guide the design and conduct of future randomized trials. PMID:22001613

Predicting intraoperative feasibility of combined TES-mMEP and cSSEP monitoring during scoliosis surgery based on preoperative neurophysiological assessment.

PubMed

Azabou, Eric; Manel, Véronique; Abelin-Genevois, Kariman; Andre-Obadia, Nathalie; Cunin, Vincent; Garin, Christophe; Kohler, Remi; Berard, Jérôme; Ulkatan, Sedat

2014-07-01

Combined monitoring of muscle motor evoked potentials elicited by transcranial electric stimulation (TES-mMEP) and cortical somatosensory evoked potentials (cSSEPs) is safe and effective for spinal cord monitoring during scoliosis surgery. However, TES-mMEP/cSSEP is not always feasible. Predictors of feasibility would help to plan the monitoring strategy. To identify predictors of the feasibility of TES-mMEP/cSSEP during scoliosis surgery. Prospective cohort study in a clinical neurophysiology unit and pediatric orthopedic department of a French university hospital. A total of 103 children aged 2 to 19 years scheduled for scoliosis surgery. Feasibility rate of intraoperative TES-mMEP/cSSEP monitoring. All patients underwent a preoperative neurological evaluation and preoperative mMEP and cSSEP recordings at both legs. For each factor associated with feasibility, we computed sensitivity, specificity, positive predictive value (PPV), and negative predictive value. A decision tree was designed. Presence of any of the following factors was associated with 100% feasibility, 100% specificity, and 100% PPV: idiopathic scoliosis, normal preoperative neurological findings, and normal preoperative mMEP and cSSEP recordings. Feasibility was 0% in the eight patients with no recordable mMEPs or cSSEPs during preoperative testing. A decision tree involving three screening steps can be used to identify patients in whom intraoperative TES-mMEP/cSSEP is feasible. Preoperative neurological and neurophysiological assessments are helpful for identifying patients who can be successfully monitored by TES-mMEP/cSSEP during scoliosis surgery. Copyright © 2014 Elsevier Inc. All rights reserved.

CPTAC Biospecimen Collection Solicitation | Office of Cancer Clinical Proteomics Research

Cancer.gov

A funding opportunity in support of the National Cancer Institute’s Clinical Proteomic Tumor Analysis Consortium (CPTAC) seeks to prospectively procure tumor samples, collected for proteomics investigation. The scope of work under this Statement of Work encompasses the activities needed to prospectively procure high quality, clinically annotated human tumor samples, blood and plasma, and when feasible, normal tissue from volunteer patients suffering from colon, ovarian, and breast cancer.

Software "Socrative" and Smartphones as Tools for Implementation of Basic Processes of Active Physics Learning in Classroom: An Initial Feasibility Study with Prospective Teachers

ERIC Educational Resources Information Center

Méndez Coca, David; Slisko, Josip

2013-01-01

Many physics professors have difficulties to know and assess in real time the learning of the students in their courses. Nevertheless, today, with Internet and the new technology devices that the students use every day, like smartphones, such tasks can be carried out relatively easy. The professor pose a few questions in "Socrative," the…

Filgrastim mobilization and collection of allogeneic blood progenitor cells from adult family donors: first interim report of a prospective German multicenter study.

PubMed

Beelen, D W; Ottinger, H; Kolbe, K; Pönisch, W; Sayer, H G; Knauf, W; Stockschläder, M; Scheid, C; Schaefer, U W

2002-12-01

Recombinant human granulocyte colony-stimulating factor (rhG-CSF) mobilized peripheral blood progenitor cells (PBPCs) from healthy individuals are a rapidly emerging alternative source to bone marrow for allogeneic transplantation. Although widely applied in the meantime, only limited information on feasibility and safety of mobilization and collection of PBPCs is currently available from prospective multicenter studies specifically designed to investigate this donation modality. This ongoing multicenter study on the performance as well as the short- and long-term safety profile of rhG-CSF-induced mobilization and collection of PBPCs was initiated in October 1999. The study is designed to recruit a total of 300 healthy family donors who will be followed regularly for a period of 5 years after donation. The first interim report presented here summarizes results obtained after enrollment of 150 donors from nine German institutions. The study protocol allowed the individual choice between two dose regimens of rh-CSF (10 micro g/kg per day vs 2x8 micro g/kg per day of donor body weight). The primary endpoint was defined as a yield of > or =5x10(6) CD34(+) cells/kg of recipient body weight in a single leukapheresis product. This endpoint was attained by 50% of donors receiving the lower rhG-CSF dose regimen and by 75% of donors with the higher dose regimen ( p<0.0009). A total of 478 acute adverse events attributable to the mobilization procedure were recorded and manifested predominantly as transient bone pain and headaches (80%). No persistent hematologic or nonhematologic adverse events have occurred in this study so far. Thus, the current experience in a prospective multicenter study supports previous single-center and retrospective registry reports in that the collection of PBPCs after rhG-CSF mobilization is feasible and associated with frequent, but generally mild and acceptable side effects.

Feasibility and Efficacy of Nurse-Driven Acute Stroke Care.

PubMed

Mainali, Shraddha; Stutzman, Sonja; Sengupta, Samarpita; Dirickson, Amanda; Riise, Laura; Jones, Donald; Yang, Julian; Olson, DaiWai M

2017-05-01

Acute stroke care requires rapid assessment and intervention. Replacing traditional sequential algorithms in stroke care with parallel processing using telestroke consultation could be useful in the management of acute stroke patients. The purpose of this study was to assess the feasibility of a nurse-driven acute stroke protocol using a parallel processing model. This is a prospective, nonrandomized, feasibility study of a quality improvement initiative. Stroke team members had a 1-month training phase, and then the protocol was implemented for 6 months and data were collected on a "run-sheet." The primary outcome of this study was to determine if a nurse-driven acute stroke protocol is feasible and assists in decreasing door to needle (intravenous tissue plasminogen activator [IV-tPA]) times. Of the 153 stroke patients seen during the protocol implementation phase, 57 were designated as "level 1" (symptom onset <4.5 hours) strokes requiring acute stroke management. Among these strokes, 78% were nurse-driven, and 75% of the telestroke encounters were also nurse-driven. The average door to computerized tomography time was significantly reduced in nurse-driven codes (38.9 minutes versus 24.4 minutes; P < .04). The use of a nurse-driven protocol is feasible and effective. When used in conjunction with a telestroke specialist, it may be of value in improving patient outcomes by decreasing the time for door to decision for IV-tPA. Copyright © 2017 National Stroke Association. Published by Elsevier Inc. All rights reserved.

[Nerve sparing techniques in deep endometriosis surgery to prevent urinary or digestive functional disorders: Techniques and results: CNGOF-HAS Endometriosis Guidelines].

PubMed

Rabischong, B; Botchorishvili, R; Bourdel, N; Curinier, S; Campagne-Loiseau, S; Pouly, J L; Canis, M

2018-03-01

To evaluate the feasibility and functional urinary and digestive results of nerve sparing techniques in endometriosis surgery. A research on the medline/pubmed database using specific keywords (nerve sparing, endometriosis, pelvic nerves) identified 7 publications among about 50 whose purpose was to describe the feasibility, the techniques and the functional results of nerve preservation in this indication. Among them there are: 2 uncontrolled retrospective studies, 3 prospective non-randomized studies, a meta-analysis and a review of the literature. Nerve preservation requires a perfect knowledge of the anatomy of the pelvic autonomic system. The laparoscopic approach is preferred by the different authors due to its anatomical advantage. The feasibility of this technique seems to be demonstrated despite certain limitations in the different studies and depending of the retroperitoneal extension of the lesions. When feasible, it is likely to significantly improve postoperative urinary function (urinary retention) compared to a conventional technique. It is observed no difference regarding digestive function. Nerve sparing in this indication is a technique the feasibility of which has been demonstrated and is subject to the topography and extent of the disease. In the absence of invasion or entrapment of pelvic autonomic nerves by endometriosis, this technique improves postoperative voiding function (NP3). During pelvic surgery for endometriosis, it is recommended to identify and preserve autonomic pelvic nerves whenever possible (GradeC). Copyright © 2018. Published by Elsevier Masson SAS.

Weekly Cisplatin and Volumetric-Modulated Arc Therapy With Simultaneous Integrated Boost for Radical Treatment of Advanced Cervical Cancer in Elderly Patients: Feasibility and Clinical Preliminary Results.

PubMed

Mazzola, Rosario; Ricchetti, Francesco; Fiorentino, Alba; Levra, Niccolò Giaj; Fersino, Sergio; Di Paola, Gioacchino; Ruggieri, Ruggero; Alongi, Filippo

2017-06-01

To evaluate the feasibility and clinical preliminary results of weekly cisplatin and volumetric-modulated arc therapy to the pelvis with simultaneous integrated boost to macroscopic disease in a cohort of elderly patients. Inclusion criteria of this prospective study were age ≥70 years, Karnofsky performance status 70 to 100, locally advanced histologically proven squamous cervical carcinoma, and patients unable to undergo brachytherapy. Radiation doses prescribed were 66 Gy to the macroscopic disease and 54 Gy to the pelvic nodes in 30 fractions. Weekly cisplatin dose was 40 mg/mq. A total of 30 patients were recruited. Median follow-up was 32 months (range: 8-48 months). Median age was 72 years (range: 70-84 years). The 3-year overall survival and local control were 93% and 80%, respectively. The median time to progression was 24 months (range: 6-30 months). Analyzing clinical outcome grouping based on the stage of disease, II versus III, the 3-year overall survival was 100% and 85%, respectively. The 3-year local control was 91% for stage II and 67% for stage III. Acute and late toxicities were acceptable without severe events. Weekly cisplatin and volumetric-modulated arc therapy-simultaneous integrated boost for radical treatment of advanced cervical cancer in the current cohort of elderly patients were feasible. Long-term results and prospective randomized trials are advocated.

Weekly Cisplatin and Volumetric-Modulated Arc Therapy With Simultaneous Integrated Boost for Radical Treatment of Advanced Cervical Cancer in Elderly Patients: Feasibility and Clinical Preliminary Results

PubMed Central

Mazzola, Rosario; Ricchetti, Francesco; Fiorentino, Alba; Levra, Niccolò Giaj; Fersino, Sergio; Di Paola, Gioacchino; Ruggieri, Ruggero

2016-01-01

Background: To evaluate the feasibility and clinical preliminary results of weekly cisplatin and volumetric-modulated arc therapy to the pelvis with simultaneous integrated boost to macroscopic disease in a cohort of elderly patients. Materials and Methods: Inclusion criteria of this prospective study were age ≥70 years, Karnofsky performance status 70 to 100, locally advanced histologically proven squamous cervical carcinoma, and patients unable to undergo brachytherapy. Radiation doses prescribed were 66 Gy to the macroscopic disease and 54 Gy to the pelvic nodes in 30 fractions. Weekly cisplatin dose was 40 mg/mq. Results: A total of 30 patients were recruited. Median follow-up was 32 months (range: 8-48 months). Median age was 72 years (range: 70-84 years). The 3-year overall survival and local control were 93% and 80%, respectively. The median time to progression was 24 months (range: 6-30 months). Analyzing clinical outcome grouping based on the stage of disease, II versus III, the 3-year overall survival was 100% and 85%, respectively. The 3-year local control was 91% for stage II and 67% for stage III. Acute and late toxicities were acceptable without severe events. Conclusion: Weekly cisplatin and volumetric-modulated arc therapy–simultaneous integrated boost for radical treatment of advanced cervical cancer in the current cohort of elderly patients were feasible. Long-term results and prospective randomized trials are advocated. PMID:27402633

Feasibility of energy medicine in a community teaching hospital: an exploratory case series.

PubMed

Dufresne, Francois; Simmons, Bonnie; Vlachostergios, Panagiotis J; Fleischner, Zachary; Joudeh, Ramsey; Blakeway, Jill; Julliard, Kell

2015-06-01

Energy medicine (EM) derives from the theory that a subtle biologic energy can be influenced for therapeutic effect. EM practitioners may be trained within a specific tradition or work solo. Few studies have investigated the feasibility of solo-practitioner EM in hospitals. This study investigated the feasibility of EM as provided by a solo practitioner in inpatient and emergent settings. Feasibility study, including a prospective case series. Inpatient units and emergency department. To investigate the feasibility of EM, acceptability, demand, implementation, and practicality were assessed. Short-term clinical changes were documented by treating physicians. Patients, employees, and family members were enrolled in the study only if study physicians expected no or slow improvement in specific symptoms. Those with secondary gains or who could not communicate perception of symptom change were excluded. EM was found to have acceptability and demand, and implementation was smooth because study procedures dovetailed with conventional clinical practice. Practicality was acceptable within the study but was low upon further application of EM because of cost of program administration. Twenty-four of 32 patients requested relief from pain. Of 50 reports of pain, 5 (10%) showed no improvement; 4 (8%), slight improvement; 3 (6%), moderate improvement; and 38 (76%), marked improvement. Twenty-one patients had issues other than pain. Of 29 non-pain-related problems, 3 (10%) showed no, 2 (7%) showed slight, 1 (4%) showed moderate, and 23 (79%) showed marked improvement. Changes during EM sessions were usually immediate. This study successfully implemented EM provided by a solo practitioner in inpatient and emergent hospital settings and found that acceptability and demand justified its presence. Most patients experienced marked, immediate improvement of symptoms associated with their chief complaint. Substantial practicality issues must be addressed to implement EM clinically in a hospital, however.

Feasibility and predictive performance of the Hendrich Fall Risk Model II in a rehabilitation department: a prospective study.

PubMed

Campanini, Isabella; Mastrangelo, Stefano; Bargellini, Annalisa; Bassoli, Agnese; Bosi, Gabriele; Lombardi, Francesco; Tolomelli, Stefano; Lusuardi, Mirco; Merlo, Andrea

2018-01-11

Falls are a common adverse event in both elderly inpatients and patients admitted to rehabilitation units. The Hendrich Fall Risk Model II (HIIFRM) has been already tested in all hospital wards with high fall rates, with the exception of the rehabilitation setting. This study's aim is to address the feasibility and predictive performances of HIIFRM in a hospital rehabilitation department. A 6 months prospective study in a Italian rehabilitation department with patients from orthopaedic, pulmonary, and neurological rehabilitation wards. All admitted patients were enrolled and assessed within 24 h of admission by means of the HIIFRM. The occurrence of falls was checked and recorded daily. HIIFRM feasibility was assessed as the percentage of successful administrations at admission. HIIFRM predictive performance was determined in terms of area under the Receiver Operating Characteristic (ROC) curve (AUC), best cutoff, sensitivity, specificity, positive and negative predictive values, along with their asymptotic 95% confidence intervals (95% CI). One hundred ninety-one patents were admitted. HIIFRM was feasible in 147 cases (77%), 11 of which suffered a fall (7.5%). Failures in administration were mainly due to bedridden patients (e.g. minimally conscious state, vegetative state). AUC was 0.779(0.685-0.873). The original HIIFRM cutoff of 5 led to a sensitivity of 100% with a mere specificity of 49%(40-57%), thus suggesting using higher cutoffs. Moreover, the median score for non-fallers at rehabilitation units was higher than that reported in literature for geriatric non fallers. The best trade-off between sensitivity and specificity was obtained by using a cutoff of 8. This lead to sensitivity = 73%(46-99%), specificity = 72%(65-80%), positive predictive value = 17% and negative predictive value = 97%. These results support the use of the HIIFRM as a predictive tool. The HIIFRM showed satisfactory feasibility and predictive performances in rehabilitation wards. Based on both available literature and these results, the prediction of falls among all hospital wards, with high risk of falling, could be achieved by means of a unique tool and two different cutoffs: a standard cutoff of 5 in geriatric wards and an adjusted higher cutoff in rehabilitation units, with predictive performances similar to those of the best-preforming pathology specific tools for fall-risk assessment.

Evaluating Integrative Cancer Clinics With the Claim Assessment Profile: An Example With the InspireHealth Clinic.

PubMed

Hilton, Lara; Elfenbaum, Pamela; Jain, Shamini; Sprengel, Meredith; Jonas, Wayne B

2018-03-01

The evaluation of freestanding integrative cancer clinical programs is challenging and is rarely done. We have developed an approach called the Claim Assessment Profile (CAP) to identify whether evaluation of a practice is justified, feasible, and likely to provide useful information. A CAP was performed in order to (1) clarify the healing claims at InspireHealth, an integrative oncology treatment program, by defining the most important impacts on its clients; (2) gather information about current research capacity at the clinic; and (3) create a program theory and path model for use in prospective research. This case study design incorporates methods from a variety of rapid assessment approaches. Procedures included site visits to observe the program, structured qualitative interviews with 26 providers and staff, surveys to capture descriptive data about the program, and observational data on program implementation. The InspireHealth program is a well-established, multi-site, thriving integrative oncology clinical practice that focuses on patient support, motivation, and health behavior engagement. It delivers patient-centered care via a standardized treatment protocol. There arehigh levels of research interest from staff and resources by which to conduct research. This analysis provides the primary descriptive and claims clarification of an integrative oncology treatment program, an evaluation readiness report, a detailed logic model explicating program theory, and a clinical outcomes path model for conducting prospective research. Prospective evaluation of this program would be feasible and valuable, adding to our knowledge base of integrative cancer therapies.

NOSE laparoscopic gastrectomies for early gastric cancer may reduce morbidity and hospital stay: early results from a prospective nonrandomized study.

PubMed

Hüscher, Cristiano G S; Lirici, Marco Maria; Ponzano, Cecilia

2017-04-01

Natural orifice specimen extraction - NOSE laparoscopy is a promising technique that avoids mini-laparotomy, possibly reducing postoperative pain, wound infections and hospital stay. Recent systematic reviews have shown that postoperative morbidity associated with laparoscopically assisted gastrectomies is similar to that after open gastrectomies. More specifically, there is no difference in wound infection rate. The study objective was to evaluate whether postoperative morbidity and hospital stay may be reduced by transoral specimen extraction after laparoscopically assisted gastrectomy for early gastric cancer (EGC). A prospective, nonrandomized study was carried out starting in August 2012. Data from all patients operated on during the first year, with minimum 18 months follow-up, were collected to assess feasibility, oncologic results, postoperative morbidity, hospital stay and functional results. Overall, 14 patients were included and followed-up. After gastric resection, a 3 cm opening was created on the gastric stump, and the specimen, divided into three segments stitched one to each other, was sutured to the gastric tube and retrieved through the mouth. Postoperative morbidity was 7.14% (1/14): one case of pneumonia. No wound infection occurred. The mean postoperative hospital stay was 4.7 ± 1.0 days. NOSE laparoscopic subtotal gastrectomy is feasible and safe, with similar oncologic results as LAG, but decreased morbidity and hospital stay.

Healing Touch as a Supportive Intervention for Adult Acute Leukemia Patients: A Pilot Investigation of Effects on Distress and Symptoms

PubMed Central

Danhauer, Suzanne C.; Tooze, Janet A.; Holder, Paige; Miller, Christina; Jesse, Michelle T.

2013-01-01

Background Goals were to determine the feasibility of conducting a study of Healing Touch (HT) for acute leukemia patients and to obtain preliminary data on its effectiveness. Methods Forty hospitalized leukemia patients completed a brief survey of HT knowledge/experience. A prospective cohort (N=12) was invited to participate in an HT intervention (9 30-minute sessions over 3 weeks); they completed measures of distress, symptoms, and sleep (at weeks 1 and 5), and completed single item ratings of fatigue, nausea, distress, and pain immediately pre-post selected HT sessions. The Wilcoxon signed rank test was used to analyze change in pre-post session ratings and distress, symptom, and sleep measures. Results Among survey respondents, 8% had used HT in the past, and 71% were interested in using HT. In the prospective cohort, there were significant pre-post session improvements in fatigue and nausea (but not in distress and pain). There were no significant changes between weeks 1 and 5 in distress, symptoms, or sleep. Ratings and qualitative feedback on HT were positive, focused mainly on feeling relaxed following HT sessions. Conclusions It is feasible to recruit patients hospitalized for acute leukemia to a study of HT. Preliminary data on short-term improvements in symptoms indicate these are promising outcomes for future study. PMID:19087765

Prevalence of patent foramen ovale and usefulness of percutaneous closure device in carcinoid heart disease.

PubMed

Mansencal, Nicolas; Mitry, Emmanuel; Pillière, Rémy; Lepère, Céline; Gérardin, Benoît; Petit, Jérôme; Gandjbakhch, Iradj; Rougier, Philippe; Dubourg, Olivier

2008-04-01

The aim of this study was to assess (1) the incidence of patent foramen ovale (PFO) in carcinoid syndrome (CS) and (2) the feasibility of percutaneous closure procedure in selected patients with CS. One hundred eight patients were prospectively studied: 54 with CS and an age- and gender-matched control group. All patients underwent conventional and contrast echocardiography. Patients with clinical signs of dyspnea (New York Heart Association class > or =III), cyanosis, carcinoid heart disease (CHD), and severe PFO were referred for the percutaneous closure of PFO. The prevalence of PFO was 41% in patients with CS and 22% in the control group (p = 0.03) and was significantly higher in patients with CHD (59%, p = 0.009). Four patients (14% of those with CHD) were referred for the percutaneous closure of PFO, and 3 patients ultimately underwent PFO closure (using Amplatzer septal occluders). At 6-month follow-up, New York Heart Association class was improved in all patients, as well as arterial blood gas results (p = 0.04) and 6-minute walking distance (p = 0.03), but all patients presented residual right-to-left shunts. In conclusion, this prospective study demonstrates that in patients with CHD, the prevalence of PFO is high and that percutaneous closure of PFO is feasible, with a reduction in symptoms but with residual shunting.

Probiotics: Prevention of Severe Pneumonia and Endotracheal Colonization Trial (PROSPECT): A Feasibility Clinical Trial

ClinicalTrials.gov

2018-03-23

Ventilator Associated Pneumonia (VAP); Other Infections; Antibiotic-Associated Diarrhea; C-Difficile; Duration of Mechanical Ventilation; Length of ICU Stay; Length of Hospital Stay; ICU and Hospital Mortality

Joint distraction for thumb carpometacarpal osteoarthritis: a feasibility study with 1-year follow-up.

PubMed

Spaans, Anne J; Minnen, L Paul van; Braakenburg, Assa; Mink van der Molen, Aebele B

2017-08-01

The purpose of this pilot study was to evaluate the feasibility of joint distraction of the first carpometacarpal (CMC1) joint in patients with CMC1 osteoarthritis (OA). An external joint distractor was placed over the CMC1 joint by K-wire fixation in the trapezium and the metacarpal. The joint was distracted 3 mm during surgery. The device was then kept in place for 8 weeks. Disabilities of the Arm, Shoulder, and Hand (DASH) score, Michigan Hand Outcome Questionnaire (MHQ), Visual Analogue Scale (VAS), and grip strength were recorded preoperatively and at set postoperative intervals. Five female patients with an average age of 53 years (range = 41-61) were included. One year postoperatively, average DASH, MHQ, and VAS scores improved compared to preoperative values; DASH 53 to 27, MHQ 48 to 76, and VAS pain 48 to 14. There were no technical problems associated with the device. One patient had a local pin site infection treated successfully with oral antibiotics. This study concludes that joint distraction of the osteoarthritic CMC1 joint is technically feasible. In this small, prospective pilot study the majority of the results were favourable during short-term follow-up.

Does live music benefits patients with brain and spinal injury?

PubMed

Zhang, C-C; Mou, L; Wang, X; Guo, D

2015-09-01

The purpose of this study is to examine the feasibility and prospective success associated with implementing and evaluating a six-week live music intervention on an inpatient neurorehabilitation ward. In total 26 patients were included in this study. Out of which, 15 were patients and 11 were staff members. Staff participants completed wellbeing measures at before and after music. Patients completed an assortment of validated measures at five consecutive time points from baseline to follow-up. Staff participants experienced a minor decrease in wellbeing over time. The majority of the data collected from patients illustrated positive trends, with improvements in wellbeing, pain, cognition functioning, independent functioning, and mobility. The feasibility indicates that with modifications that this project is a viable venture. We found that live music appears to be promising new addition to neurorehabilitation.

A prospective trial of hyperbaric oxygen for chronic sequelae after brain injury (HYBOBI).

PubMed

Churchill, Susan; Weaver, Lindell K; Deru, Kayla; Russo, Antonietta A; Handrahan, Diana; Orrison, William W; Foley, John F; Elwell, Heather A

2013-01-01

Some practitioners advocate hyperbaric oxygen (HBO2) for sequelae following brain injury. This study assessed recruitment, tolerance and safety in preparation for a randomized clinical trial. Prospective, open-label feasibility study. Hyperbaric medicine department of a tertiary academic hospital. Participatory adult outpatients with problems from stroke (n=22), anoxia (13) or trauma (28) that occurred at least 12 months before enrollment, without contraindications to HBO2. Sixty-three participants enrolled in the study (21 females,42 males). Age was 45 +/- 16 years (18-76) and time from injury was 6.9 +/- 7.1 years (1.0-29.3). Fifty-three completed the study intervention, and 55 completed the assessment battery. PARTICIPANTS underwent 60 daily HBO2 sessions (1.5 atm abs, 100% oxygen, 60 minutes). Assessments were conducted at baseline, after the HBO2 course, and six months later. The prime outcome was feasibility. To estimate the immediate and long-term effects of HBO2, we assessed neuropsychological measures, questionnaires, neurologic exam and physical functioning measures. Some participants also had pre- and post-HBO2 speech evaluation (n=27) and neuroimaging (n=17). The study met our a priori definition for feasibility for recruitment, but 44% required additional time to complete the 60 sessions (up to 105 days). HBO2-related adverse events were rare and not serious. Although many participants reported improvement in symptoms (51% memory, 51% attention/concentration, 48% balance/coordination, 45% endurance, 20% sleep) post-HBO2, and 93% reported that they would participate in the study again, no standardized testing showed clinically important improvement. In the small subset of those undergoing neuroimaging, apparent improvement was observed in auditory functional MRI (8/13), MR spectroscopy (9/17) and brain perfusionby CT angiography (5/9). Conducting an HBO2 clinical trial in this population was feasible. Although many participants reported improvement, the lack of concurrent controls limits the strength of inferences from this trial, especially considering lack of change in standardized testing. The clinical relevance of neuroimaging changes is unknown. The findings of this study may indicate a need for caution when considering the broad application of HBO2 more than one year after brain injury due to stroke, severe TBI and anoxia, until there is more compelling evidence from carefully designed sham-controlled, blinded clinical trials.

A novel hemostatic powder for upper gastrointestinal bleeding: a multicenter study (the "GRAPHE" registry).

PubMed

Haddara, Sami; Jacques, Jeremie; Lecleire, Stéphane; Branche, Julien; Leblanc, Sarah; Le Baleur, Yann; Privat, Jocelyn; Heyries, Laurent; Bichard, Philippe; Granval, Philippe; Chaput, Ulriikka; Koch, Stephane; Levy, Jonathan; Godart, Bruno; Charachon, Antoine; Bourgaux, Jean-François; Metivier-Cesbron, Elodie; Chabrun, Edouard; Quentin, Vincent; Perrot, Bastien; Vanbiervliet, Geoffroy; Coron, Emmanuel

2016-12-01

Background and study aims: The hemostatic powder TC-325 (Hemospray; Cook Medical, Winston-Salem, North Carolina, USA) has shown promising results in the treatment of upper gastrointestinal bleeding (UGIB) in expert centers in pilot studies. The aim of this study was to evaluate the feasibility and efficacy of TC-325 in a large prospective registry of use in routine practice. Patients and methods: The data of all patients treated with TC-325 were prospectively collected through a national registry. Outcomes were the immediate feasibility and efficacy of TC-325 application, as well as the rates of rebleeding at Day 8 and Day 30. Multivariate analysis was performed to determine predictive factors of rebleeding. Results: A total of 202 patients were enrolled and 64 endoscopists participated from 20 centers. TC-325 was used as salvage therapy in 108 patients (53.5 %). The etiology of bleeding was an ulcer in 75 patients (37.1 %), tumor in 61 (30.2 %), postendoscopic therapy in 35 (17.3 %), or other in 31 (15.3 %). Application of the hemostatic powder was found to be very easy or easy in 31.7 % and 55.4 %, respectively. The immediate efficacy rate was 96.5 %. Recurrence of UGIB was noted at Day 8 and Day 30 in 26.7 % and 33.5 %, respectively. Predictive factors of recurrence at Day 8 were melena at initial presentation and use of TC-325 as salvage therapy. Conclusion: These multicenter data confirmed the high rate of immediate hemostasis, excellent feasibility, and good safety profile of TC-325, which could become the treatment of choice in bleeding tumors or postendoscopic bleeding but not in bleeding ulcers where randomized studies are needed. ClinicalTrials.gov (NCT02595853). © Georg Thieme Verlag KG Stuttgart · New York.

Blood pressure self-monitoring in pregnancy: examining feasibility in a prospective cohort study.

PubMed

Tucker, Katherine L; Taylor, Kathryn S; Crawford, Carole; Hodgkinson, James A; Bankhead, Clare; Carver, Tricia; Ewers, Elizabeth; Glogowska, Margaret; Greenfield, Sheila M; Ingram, Lucy; Hinton, Lisa; Khan, Khalid S; Locock, Louise; Mackillop, Lucy; McCourt, Christine; Pirie, Alexander M; Stevens, Richard; McManus, Richard J

2017-12-28

Raised blood pressure (BP) affects approximately 10% of pregnancies worldwide, and a high proportion of affected women develop pre-eclampsia. This study aimed to evaluate the feasibility of self-monitoring of BP in pregnancy in women at higher risk of pre-eclampsia. This prospective cohort study of self-monitoring BP in pregnancy was carried out in two hospital trusts in Birmingham and Oxford and thirteen primary care practices in Oxfordshire. Eligible women were those defined by the UK National Institute for Health and Care Excellence (NICE) guidelines as at higher risk of pre-eclampsia. A total of 201 participants were recruited between 12 and 16 weeks of pregnancy and were asked to take two BP readings twice daily three times a week through their pregnancy. Primary outcomes were recruitment, retention and persistence of self-monitoring. Study recruitment and retention were analysed with descriptive statistics. Survival analysis was used to evaluate the persistence of self-monitoring and the performance of self-monitoring in the early detection of gestational hypertension, compared to clinic BP monitoring. Secondary outcomes were the mean clinic and self-monitored BP readings and the performance of self-monitoring in the detection of gestational hypertension and pre-eclampsia compared to clinic BP. Of 201 women recruited, 161 (80%) remained in the study at 36 weeks or to the end of their pregnancy, 162 (81%) provided any home readings suitable for analysis, 148 (74%) continued to self-monitor at 20 weeks and 107 (66%) at 36 weeks. Self-monitored readings were similar in value to contemporaneous matched clinic readings for both systolic and diastolic BP. Of the 23 who developed gestational hypertension or pre-eclampsia and self-monitored, 9 (39%) had a raised home BP prior to a raised clinic BP. Self-monitoring of BP in pregnancy is feasible and has potential to be useful in the early detection of gestational hypertensive disorders but maintaining self-monitoring throughout pregnancy requires support and probably enhanced training.

Short-term Clinical Course of Knee Pain in Children and Adolescents: A Feasibility Study Using Electronic Methods of Data Collection.

PubMed

Swain, Michael S; Kamper, Steven J; Maher, Chris G; Latimer, Jane; Broderick, Carolyn; McKay, Damien; Henschke, Nicholas

2017-10-01

Musculoskeletal disorders, such as knee pain, are common in children and adolescents, but there is a lack of high quality research that evaluates the clinical course of these conditions. The objective of this study was to evaluate the feasibility of conducting a prospective study of children and adolescents with knee pain using electronic methods of data collection. Children and adolescents with knee pain that presented to primary care physiotherapy clinics were enrolled and followed-up on a weekly basis via short messaging service (SMS) until their knee pain had recovered (i.e. two consecutive weeks of no pain). Feasibility was assessed in terms of recruitment, retention and response rates to SMS and an online questionnaire. Baseline and 6-month follow-up measures included pain, disability, physical function, physical activity and health related quality of life. Kaplan-Meier survival analysis was used to estimate the median time to knee pain recovery. Thirty participants (mean age 13.0 ± 2.2 years, 53% boys) were recruited over 26 months. The overall response rate to weekly SMS follow-up was 71.3% (809 received/1135 sent). One third of participants stopped responding to SMS prior to recovery, and these participants typically had a much lower response rate during the time they remained in the study. At 6-month follow-up, 80% of the cohort completed the final online questionnaire, and 29% of participants still reported current knee pain (≥1/10 VAS). The median time for knee pain recovery was 8 weeks (95%CI: 5, 10). Electronic data collection alone seems insufficient to track pain recovery in young people and may need to be supplemented with more traditional data collection methods. Researchers should consider further measures to address slow recruitment rates and high attrition when designing large prospective studies of children and adolescents in the future. Copyright © 2016 John Wiley & Sons, Ltd. Copyright © 2016 John Wiley & Sons, Ltd.

Novel, Family-Centered Intervention to Improve Nutrition in Patients Recovering From Critical Illness: A Feasibility Study.

PubMed

Marshall, Andrea P; Lemieux, Margot; Dhaliwal, Rupinder; Seyler, Hilda; MacEachern, Kristen N; Heyland, Daren K

2017-06-01

Critically ill patients are at increased risk of developing malnutrition-related complications because of physiological changes, suboptimal delivery, and reduced intake. Strategies to improve nutrition during critical illness recovery are required to prevent iatrogenic underfeeding and risk of malnutrition. The purpose of this study was to assess the feasibility and acceptability of a novel family-centered intervention to improve nutrition in critically ill patients. A 3-phase, prospective cohort feasibility study was conducted in 4 intensive care units (ICUs) across 2 countries. Intervention feasibility was determined by patient eligibility, recruitment, and retention rates. The acceptability of the intervention was assessed by participant perspectives collected through surveys. Participants included family members of the critically ill patients and ICU and ward healthcare professionals (HCPs). A total of 75 patients and family members, as well as 56 HCPs, were enrolled. The consent rate was 66.4%, and 63 of 75 (84%) of family participants completed the study. Most family members (53/55; 98.1%) would recommend the nutrition education program to others and reported improved ability to ask questions about nutrition (16/20; 80.0%). Family members viewed nutrition care more positively in the ICU. HCPs agreed that families should partner with HCPs to achieve optimal nutrition in the ICU and the wards. Health literacy was identified as a potential barrier to family participation. The intervention was feasible and acceptable to families of critically ill patients and HCPs. Further research to evaluate intervention impact on nutrition intake and patient-centered outcomes is required.

Anticipatory precrash restraint sensor feasibility study: Final report

DOE Office of Scientific and Technical Information (OSTI.GOV)

Kercel, S.W.; Dress, W.B.

1995-08-01

This report explores feasibility of an anticipatory precrash restraint sensor. The foundation principle is the anticipation mechanism found at a primitive level of biological intelligence and originally formalized by the mathematical biologist Robert Rosen. A system based on formal anticipatory principles should significantly outperform conventional technologies. It offers the prospect of high payoff in prevention of death and injury. Sensors and processes are available to provide a good, fast, and inexpensive description of the present dynamical state of the vehicle to the embedded system model in the anticipation engine. The experimental part of this study found that inexpensive radar inmore » a real-world setting does return useful data on target dynamics. The data produced by a radar system can be converted to target dynamical information by good, fast and inexpensive signal-processing techniques. Not only is the anticipatory sensor feasible, but further development under the sponsorship of the National Highway Traffic Safety Administration is necessary and desirable. There are a number of possible lines of follow-on investigation. The level of effort and expected benefits of various alternatives are discussed.« less

District heating and cooling feasibility study, Dunkirk, New York

DOE Office of Scientific and Technical Information (OSTI.GOV)

Not Available

The objective of this project is to perform a preliminary investigation of the technical and economic feasibility of implementing a district heating and cooling (DHC) system in the City of Dunkirk, New York. The study was conducted by first defining a heating and cooling (HC) load service area. Then, questionnaires were sent to prospective DHC customers. After reviewing the owners responses, large consumers of energy were interviewed for more detail of their HC systems, including site visits, to determine possibilities of retrofitting their systems to district heating and cooling. Peak HC loads for the buildings were estimated by Burns andmore » Roe's in-house computer programs. Based on the peak loads, certain customers were determined for suitability as anchor customers. Various options using cogeneration were investigated for possible HC sources. Equipment for HC sources and HC loads were sized and their associated costs estimated. Finally, economic analyses were performed. The conclusion is that it is technically and economically feasible to implement a district heating and cooling system in the City of Dunkirk. 14 figs., 15 tabs.« less

The Role of Telemedicine in Auditory Rehabilitation: A Systematic Review.

PubMed

Bush, Matthew L; Thompson, Robin; Irungu, Catherine; Ayugi, John

2016-12-01

The purpose of this study was to assess the feasibility and effectiveness of live telemedicine applications in hearing amplification and cochlear implantation. A systematic search was performed in PubMed, MEDLINE, PsychINFO, CINALH, and Web of Science to identify peer-reviewed research. Inclusion criteria were titles containing words from the search terms 1) audiology, otolaryngology, and hearing impairment, 2) rehabilitative methods, and 3) telemedicine. Exclusion criteria were: 1) non-English articles, and 2) non-original research. Twelve eligible studies were identified. The studies employed a prospective design in nine of the articles and retrospective case series in three. The use of telemedicine for the provision of cochlear implant services was examined in eight of the articles and with hearing aids in four of the articles. The types of services include intraoperative cochlear implant telemetry; implant programming and assessment of electrode-specific measures and speech recognition after implantation. Hearing aid programming and remote gain assessments were also reported. Many studies assess patient and provider satisfaction along with encounter time comparison. The studies occurred from 2009 to 2014 and took place in seven countries. This review examined the feasibility of remote telemedicine connection to provide in auditory rehabilitation services through hearing aids and cochlear implants. There are significant concerns regarding Internet bandwidth limitations for remote clinics. There is a paucity of research examining reimbursement and cost-effectiveness for services. Further prospective research investigating cost-effectiveness and bandwidth limitations is warranted to assess long-term sustainability of remote audiological rehabilitative service delivery.

Availability and feasibility of structured, routine collection of comorbidity data in a colorectal cancer multi-disciplinary team (MDT) setting.

PubMed

Abukar, A A; Ramsanahie, A; Martin-Lumbard, K; Herrington, E R; Winslow, V; Wong, S; Ahmed, S; Thaha, M A

2018-05-03

Availability of comorbidity assessment at multi-disciplinary team (MDT) discussions is cornerstone in making the MDT process more robust and decisive in optimising treatment and improving quality of survivorship. Comorbidity assessments using tools, such as the ACE-27 questionnaire would aid in optimising the decision-making process at MDTs so that treatment decisions can be made without delay. This study determined the availability of comorbidity data in a CRC MDT and the feasibility of routine comorbidity data collection using the validated ACE-27 questionnaire. Secondary aims determined the optimal time and method of collecting comorbidity data. A retrospective mapping exercise (phase I; 6-months) examined the availability of comorbidity data within the MDT. Phase II prospectively collected comorbidity data using ACE-27 for a 3-month period following a short pilot. In phase I, 73/135 (54%) patients had comorbidity data readily available informing the MDT discussion; 62 patients lacked this information. After a review of the patient records, it was clear that 41 of these 62 also had comorbidities and 21 out of the 135 had ≥ 2 major system disorders. Common referral sources to the MDT were surgical outpatient clinics (42%) and the endoscopy unit (13%). The average lead-time from referral to MDT discussion was 14 days. In phase II, an ACE-27 questionnaire was prospectively administered in 50 patients, mean age 54 years (range 20-84). Male: female ratio 26:24. Average time to administer ACE-27 was 4.8 min (range 1-15). The phase I study confirmed the widely acknowledged view of poor comorbidity data availability within a CRC MDT. Phase II demonstrated the feasibility of routinely collecting comorbidity data using ACE-27.

Achieving high convection volumes in postdilution online hemodiafiltration: a prospective multicenter study

PubMed Central

Chapdelaine, Isabelle; Nubé, Menso J; Blankestijn, Peter J; Bots, Michiel L; Konings, Constantijn J A M; Kremer Hovinga, Ton K; Molenaar, Femke M; van der Weerd, Neelke C; Grooteman, Muriel P C

2017-01-01

Abstract Background. Available evidence suggests a reduced mortality risk for patients treated with high-volume postdilution hemodiafiltration (HDF) when compared with hemodialysis (HD) patients. As the magnitude of the convection volume depends on treatment-related factors rather than patient-related characteristics, we prospectively investigated whether a high convection volume (defined as ≥22 L/session) is feasible in the majority of patients (>75%). Methods. A multicenter study was performed in adult prevalent dialysis patients. Nonparticipating eligible patients formed the control group. Using a stepwise protocol, treatment time (up to 4 hours), blood flow rate (up to 400 mL/min) and filtration fraction (up to 33%) were optimized as much as possible. The convection volume was determined at the end of this optimization phase and at 4 and 8 weeks thereafter. Results. Baseline characteristics were comparable in participants (n = 86) and controls (n = 58). At the end of the optimization and 8 weeks thereafter, 71/86 (83%) and 66/83 (80%) of the patients achieved high-volume HDF (mean 25.5 ± 3.6 and 26.0 ± 3.4 L/session, respectively). While treatment time remained unaltered, mean blood flow rate increased by 27% and filtration fraction increased by 23%. Patients with <22 L/session had a higher percentage of central venous catheters (CVCs), a shorter treatment time and lower blood flow rate when compared with patients with ≥22 L/session. Conclusions. High-volume HDF is feasible in a clear majority of dialysis patients. Since none of the patients agreed to increase treatment time, these findings indicate that high-volume HDF is feasible just by increasing blood flow rate and filtration fraction. PMID:29225810

Using prospective hazard analysis to assess an active shooter emergency operations plan.

PubMed

Card, Alan J; Harrison, Heidi; Ward, James; Clarkson, P John

2012-01-01

Most risk management activity in the healthcare sector is retrospective, based on learning from experience. This is feasible where the risks are routine, but emergency operations plans (EOP) guide the response to events that are both high risk and rare. Under these circumstances, it is important to get the response right the first time, but learning from experience is usually not an option. This case study presents the rationale for taking a proactive approach to improving healthcare organizations' EOP. It demonstrates how the Prospective Hazard Analysis (PHA) Toolkit can drive organizational learning and argues that this toolkit may lead to more efficient improvement than drills and exercises. © 2012 American Society for Healthcare Risk Management of the American Hospital Association.

"FIND Technology": investigating the feasibility, efficacy and safety of controller-free interactive digital rehabilitation technology in an inpatient stroke population: study protocol for a randomized controlled trial.

PubMed

Bird, M L; Cannell, J; Callisaya, M L; Moles, E; Rathjen, A; Lane, K; Tyson, A; Smith, S

2016-04-16

Stroke results in significant disability, which can be reduced by physical rehabilitation. High levels of repetition and activity are required in rehabilitation, but patients are typically sedentary. Using clinically relevant and fun computer games may be one way to achieve increased activity in rehabilitation. A single-blind randomized controlled trial will be conducted to evaluate the feasibility, efficacy and safety of novel stroke-specific rehabilitation software. This software uses controller-free client interaction and inertial motion sensors. Elements of feasibility include recruitment into the trial, ongoing participation (adherence and dropout), perceived benefit, enjoyment and ease of use of the games. Efficacy will be determined by measuring activity and using upper-limb tasks as well as measures of balance and mobility. The hypothesis that the intervention group will have increased levels of physical activity within rehabilitation and improved physical outcomes compared with the control group will be tested. Results from this study will provide a basis for discussion of feasibility of this interactive video technological solution in an inpatient situation. Differences in activity levels between groups will be the primary measure of efficacy. It will also provide data on measures of upper-limb function, balance and mobility. ACTRN12614000427673 . Prospectively registered 17 April 2014.

Elastic Scattering Spectroscopy for the Detection of Pre-Cancer and Early Cancer of the Breast

DTIC Science & Technology

2006-06-01

and it is not currently possible even to use biopsy forceps through the sheath alone. However, it is practical to pass an ESS probe through the...to accept our ESS probe, tiny biopsy forceps or brushes for cytological PAGE 53 PAGE 54 examination. We envisage being able to take...ductoscopy (where biopsy is not feasible) and detect aneuploidy, an important prognostic factor. These results justify further prospective studies

A theory-based decision aid for patients with cancer: results of feasibility and acceptability testing of DecisionKEYS for cancer.

PubMed

Hollen, Patricia J; Gralla, Richard J; Jones, Randy A; Thomas, Christopher Y; Brenin, David R; Weiss, Geoffrey R; Schroen, Anneke T; Petroni, Gina R

2013-03-01

Appropriate utilization of treatment is a goal for all patients undergoing cancer treatment. Proper treatment maximizes benefit and limits exposure to unnecessary measures. This report describes findings of the feasibility and acceptability of implementing a short, clinic-based decision aid and presents an in-depth clinical profile of the participants. This descriptive study used a prospective, quantitative approach to obtain the feasibility and acceptability of a decision aid (DecisionKEYS for Balancing Choices) for use in clinical settings. It combined results of trials of patients with three different common malignancies. All groups used the same decision aid series. Participants included 80 patients with solid tumors (22 with newly diagnosed breast cancer, 19 with advanced prostate cancer, and 39 with advanced lung cancer) and their 80 supporters as well as their physicians and nurses, for a total of 160 participants and 10 health professionals. The decision aid was highly acceptable to patient and supporter participants in all diagnostic groups. It was feasible for use in clinic settings; the overall value was rated highly. Of six physicians, all found the interactive format with the help of the nurse as feasible and acceptable. Nurses also rated the decision aid favorably. This intervention provides the opportunity to enhance decision making about cancer treatment and warrants further study including larger and more diverse groups. Strengths of the study included a theoretical grounding, feasibility testing of a practical clinic-based intervention, and summative evaluation of acceptability of the intervention by patient and supporter pairs. Further research also is needed to test the effectiveness of the decision aid in diverse clinical settings and to determine if this intervention can decrease overall costs.

The Aging, Community and Health Research Unit-Community Partnership Program for older adults with type 2 diabetes and multiple chronic conditions: a feasibility study.

PubMed

Markle-Reid, Maureen; Ploeg, Jenny; Fisher, Kathryn; Reimer, Holly; Kaasalainen, Sharon; Gafni, Amiram; Gruneir, Andrea; Kirkconnell, Ross; Marzouk, Sam; Akhtar-Danesh, Noori; Thabane, Lehana; Rojas-Fernandez, Carlos; Upshur, Ross

2016-01-01

Few studies have examined the effectiveness of community-based self-management interventions in older adults with type 2 diabetes mellitus (T2DM) and multiple chronic conditions (MCC). The objectives of this study were to examine the feasibility of implementation in practice (primary) and the feasibility of study methods and potential effectiveness (secondary) of the Aging, Community and Health-Community Partnership Program, a new 6-month interprofessional, nurse-led program to promote diabetes self-management in older adults (>65 years) with T2DM and MCC. This study used a prospective one-group pre-test/post-test design. Participants were recruited from a specialized diabetes clinic. They received a median of three in-home/clinic visits by certified diabetes educators (CDEs) and attended a median of three group wellness sessions provided by the CDEs in partnership with a community-based seniors' association. The primary outcome was the feasibility of the program (acceptability, fidelity, implementation barriers/facilitators). Secondary outcomes included the feasibility of the study methods (recruitment/retention rates and procedures, eligibility criteria, data collection and analysis methods) and potential effectiveness of the program based on 6-month changes in self-reported outcomes including self-management behavior (diet, exercise, self-monitoring), health status (quality of life, mental health), and costs of service use. Analysis of feasibility outcomes was primarily based on descriptive statistics. The potential effectiveness of the program was explored using different tests, with the results expressed using descriptive statistics and effect estimates (95 % confidence intervals). In total, 45 (88 %) of 51 eligible persons consented to participate. Of these, 37 (82 %) completed the 6-month follow-up. Participants and providers viewed the program as acceptable and feasible. Participants had a higher SF-12 physical component summary score at 6 months compared with baseline (mean score difference 3.0, 95 % CI 0.2-5.8). Median costs for diabetes care increased over 6 months (reflecting inclusion of program costs), while other service costs either decreased or remained unchanged. This study offers preliminary evidence that the program was feasible to deliver and acceptable to participants and providers. Initial results suggest that the program may improve physical functioning. A randomized controlled trial is feasible, with some adaptations to the program and study methods that were identified from this feasibility study. Clinicaltrials.gov identifier: NCT01880476.

Physiological and Performance Measures for Baseline Concussion Assessment.

PubMed

Dobney, Danielle M; Thomas, Scott G; Taha, Tim; Keightley, Michelle

2017-05-17

Baseline testing is a common strategy for concussion assessment and management. Research continues to evaluate novel measures for potential to improve baseline testing methods. The primary objective was to; 1) determine the feasibility of including physiological, neuromuscular and mood measures as part of baseline concussion testing protocol, 2) describe typical values in a varsity athlete sample, and 3) estimate the influence of concussion history on these baseline measures. Prospective observational study. University Athletic Therapy Clinic. 100 varsity athletes. Frequency and domain measures of heart rate variability (HRV), blood pressure (BP), grip strength, Profile of Mood States and the Sport Concussion Assessment Tool-2. Physiological, neuromuscular performance and mood measures were feasible at baseline. Participants with a history of two or more previous concussions displayed significantly higher diastolic blood pressure. Females reported higher total mood disturbance compared to males. Physiological and neuromuscular performance measures are safe and feasible as baseline concussion assessment outcomes. History of concussion may have an influence on diastolic blood pressure.

Feasibility and validity of frailty measurement in geriatric rehabilitation.

PubMed

Arjunan, Aparna; Peel, Nancye M; Hubbard, Ruth E

2018-02-10

The measurement of frailty using a Frailty Index (FI) has been criticised as too time-consuming for use in hospital settings. We aimed to assess the feasibility and characteristics of an FI derived from routinely collected data. A total of 258 participants aged 65 and older were included in a single-centre prospective cohort study conducted in inpatient geriatric rehabilitation wards. The functional independence measure (FIM™), medication count and comorbidities were coded as deficits. An FI could be derived in all participants. It was normally distributed with a mean (SD) of 0.42 (0.13) and reached a submaximal limit of 0.69. Adjusting for age and sex, the odds ratio of a poor outcome (death/discharge to higher care) was 1.38 (confidence interval 1.11-1.70) per unit (0.1) increase in FI. Derivation of an FI from routinely collected data is feasible in geriatric rehabilitation settings and is predictive of poor outcomes. © 2018 AJA Inc.

Remote Ambulatory Management of Veterans with Obstructive Sleep Apnea

PubMed Central

Fields, Barry G.; Behari, Pratima Pathak; McCloskey, Susan; True, Gala; Richardson, Diane; Thomasson, Arwin; Korom-Djakovic, Danijela; Davies, Keith; Kuna, Samuel T.

2016-01-01

Study Objectives: Despite significant medical sequelae of obstructive sleep apnea (OSA), the condition remains undiagnosed and untreated in many affected individuals. We explored the feasibility of a comprehensive, telemedicine-based OSA management pathway in a community-based Veteran cohort. Methods: This prospective, parallel-group randomized pilot study assessed feasibility of a telemedicine-based pathway for OSA evaluation and management in comparison to a more traditional, in-person care model. The study included 60 Veterans at the Philadelphia Veterans Affairs Medical Center and two affiliated community-based outpatient clinics. Telemedicine pathway feasibility, acceptability, and outcomes were assessed through a variety of quantitative (Functional Outcomes of Sleep Questionnaire, dropout rates, positive airway pressure [PAP] adherence rates, participant satisfaction ratings) and qualitative (verbal feedback) metrics. Results: There was no significant difference in functional outcome changes, patient satisfaction, dropout rates, or objectively measured PAP adherence between groups after 3 months of treatment. Telemedicine participants showed greater improvement in mental health scores, and their feedback was overwhelmingly positive. Conclusions: Our pilot study suggests that telemedicine-based management of OSA patients is feasible in terms of patient functional outcomes and overall satisfaction with care. Future studies should include larger populations to further elucidate these findings while assessing provider- and patient-related cost effectiveness. Citation: Fields BG, Behari PP, McCloskey S, True G, Richardson D, Thomasson A, Korom-Djakovic D, Davies K, Kuna ST. Remote ambulatory management of veterans with obstructive sleep apnea. SLEEP 2016;39(3):501–509. PMID:26446115

Prospective Observational Study of Single-Site Multiport Per-umbilical Laparoscopic Endosurgery versus Conventional Multiport Laparoscopic Cholecystectomy: Critical Appraisal of a Unique Umbilical Approach

PubMed Central

Jategaonkar, Priyadarshan Anand; Yadav, Sudeep Pradeep

2014-01-01

Purpose. This prospective observational study compares an innovative approach of Single-Site Multi-Port Per-umbilical Laparoscopic Endo-surgery (SSMPPLE) cholecystectomy with the gold standard—Conventional Multi-port Laparoscopic Cholecystectomy (CMLC)—to assess the feasibility and efficacy of the former. Methods. In all, 646 patients were studied. SSMPPLE cholecystectomy utilized three ports inserted through three independent mini-incisions at the umbilicus. Only the day-to-day rigid laparoscopic instruments were used in all cases. The SSMPPLE cholecystectomy group had 320 patients and the CMLC group had 326 patients. The outcomes were statistically compared. Results. SSMPPLE cholecystectomy had average operative time of 43.8 min and blood loss of 9.4 mL. Their duration of hospitalization was 1.3 days (range, 1–5). Six patients (1.9%) of this group were converted to CMLC. Eleven patients had controlled gallbladder perforations at dissection. The Visual Analogue Scores for pain on postoperative days 0 and 7, the operative time, and the scar grades were significantly better for SSMPPLE than CMLC. However, umbilical sepsis and seroma outcomes were similar. We had no bile-duct injuries or port-site hernias in this study. Conclusion. SSMPPLE cholecystectomy approach complies with the principles of laparoscopic triangulation; it seems feasible and safe method of minimally invasive cholecystectomy. Overall, it has a potential to emerge as an economically viable alternative to single-port surgery. PMID:24876955

A prospective evaluation of a standardized strategy for the use of a polymeric everolimus-eluting bioresorbable scaffold in ST-segment elevation myocardial infarction: Rationale and design of the BVS STEMI STRATEGY-IT study.

PubMed

Ielasi, Alfonso; Varricchio, Attilio; Campo, Gianluca; Leoncini, Massimo; Cortese, Bernardo; Vicinelli, Paolo; Brugaletta, Salvatore; di Uccio, Fortunato Scotto; Latib, Azeem; Tespili, Maurizio

2017-06-01

To assess the feasibility and the clinical results following a prespecified bioresorbable vascular scaffold (Absorb BVS) implantation strategy in ST-elevation myocardial infarction (STEMI) patients. Concerns raised about the BVS safety in STEMI setting because a not negligible thrombosis rate was reported within 30 days and 12 months after implantation. Technical procedural issues related to the structural BVS features were advocated as probable causes for the thrombotic events. This is an investigators-owned and -directed, prospective, nonrandomized, single-arm multicenter registry intended to obtain data from 500 consecutive STEMI patients undergoing primary PCI with BVS (1.1 or GT1) following a prespecified implantation protocol. The study is recorded in ClinicalTrials.gov with the identifier: NCT02601781. The primary endpoint is a device-oriented composite end-point (DOCE) of cardiac death, any myocardial infarction clearly attributable to the intervention culprit vessel and ischemic-driven target lesion revascularization within 30 days after the index procedure. The DOCE will be assessed even at 6-month, 1-, 3-, and 5-year follow-up. This will be the first study investigating the feasibility and the early- and long-term clinical impact of a prespecified BVS implantation protocol in thrombotic lesions causing STEMI. Here, we describe the rationale and the design of the study. © 2016 Wiley Periodicals, Inc. © 2016 Wiley Periodicals, Inc.

An eHealth Application of Self-Reported Sports-Related Injuries and Illnesses in Paralympic Sport: Pilot Feasibility and Usability Study

PubMed Central

2017-01-01

Background Sport participation is associated with a risk of sports-related injuries and illnesses, and Paralympic athletes’ additional medical issues can be a challenge to health care providers and medical staff. However, few prospective studies have assessed sports-related injuries and illnesses in Paralympic sport (SRIIPS) over time. Advances in mobile phone technology and networking systems offer novel opportunities to develop innovative eHealth applications for collection of athletes’ self-reports. Using eHealth applications for collection of self-reported SRIIPS is an unexplored area, and before initiation of full-scale research of SRIIPS, the feasibility and usability of such an approach needs to be ascertained. Objective The aim of this study was to perform a 4-week pilot study and (1) evaluate the monitoring feasibility and system usability of a novel eHealth application for self-reported SRIIPS and (2) report preliminary data on SRIIPS. Methods An eHealth application for routine collection of data from athletes was developed and adapted to Paralympic athletes. A 4-week pilot study was performed where Paralympic athletes (n=28) were asked to weekly self-report sport exposure, training load, general well-being, pain, sleep, anxiety, and possible SRIIPS. The data collection was followed by a poststudy use assessment survey. Quantitative data related to the system use (eg, completed self-reports, missing responses, and errors) were analyzed using descriptive statistics. The qualitative feasibility and usability data provided by the athletes were condensed and categorized using thematic analysis methods. Results The weekly response rate was 95%. The athletes were of the opinion that the eHealth application was usable and feasible but stated that it was not fully adapted to Paralympic athletes and their impairments. For example, it was difficult to understand how a new injury or illness should be identified when the impairment was involved. More survey items related to the impairments were requested, as the athletes perceived that injuries and illnesses often occurred because of the impairment. Options for description of multifactorial incidents including an injury, an illness, and the impairment were also insufficient. Few technical issues were encountered, but athletes with visual impairment reported usability difficulties with the speech synthesizer. An incidence rate of 1.8 injuries and 1.7 illnesses per 100 hours of athlete exposure were recorded. The weekly pain prevalence was 56% and the impairment contributed to 20% of the reported incidents. Conclusions The novel eHealth-based application for self-reported SRIIPS developed and tested in this pilot study was generally feasible and usable. With some adaptation to accommodate Paralympic athletes’ prerequisites and improved technical support for athletes with visual impairment, this application can be recommended for use in prospective studies of SRIIPS. Trial Registration ClinicalTrials.gov NCT02788500; https://clinicaltrials.gov/ct2/show/NCT02788500 (Archived by WebCite at http://www.webcitation.org/6v56OqTeP) PMID:29187343

Is it feasible to discuss an advance directive with a Chinese patient with advanced malignancy? A prospective cohort study.

PubMed

Wong, S Y; Lo, S H; Chan, C H; Chui, H S; Sze, W K; Tung, Y

2012-06-01

Advance directives have been implemented for years in western countries, but the concept is new to Asian cultures. According to traditional Chinese culture, family members usually play a decisive role in a patient's treatment plan. Thus it may be hard to implement an advance directive despite its importance to the treatment of patients. The objectives of this study were to assess the feasibility of advance directive engagement and to explore significant contributing factors to achieving such a goal. Prospective cohort study. Palliative Care Unit of Clinical Oncology, Tuen Mun Hospital, Hong Kong. The subjects of the investigation were adult patients diagnosed to have advanced malignancy and newly referred to the hospice service from 24 April 2009 to 30 July 2009. Data were collected from nursing assessment forms, locally designed advance directive forms, a checklist completed by oncologists, and details available in the electronic hospital record. Of the 191 eligible patients, 120 (63%) had the advance directive, whereas 71 (37%) did not. In the Cox regression model, the patient having insight of a poor prognosis was the most significant factor facilitating advance directive engagement (P=0.001). Any family objection in the discussion of advance directives was also an important factor, though it did not reach statistical significance (P=0.082). Other factors like age, gender, education, religion, financial status, living environment, understanding the diagnosis, bereavement experience, type of cancer, nature of illness, courses of chemotherapy or radiotherapy received, main caregiver, in-house supporter, nurse-led clinic attendance, clinical psychologist consultation, and in-patient hospice nurse coordinator interview were all statistically insignificant. Our study demonstrated that it was feasible to discuss an advance directive with Chinese patients with advanced malignancy. When patients have insight about their poor prognosis and family members have no objection, it may be appropriate to discuss an advance directive.

Is My Facility a Good Candidate for CHP?

EPA Pesticide Factsheets

Learn if a facility is a good candidate for CHP by answering a list of questions, and access the CHP Spark Spread Estimator, a tool that helps evaluate a prospective CHP system for its potential economic feasibility.

Prospects for elimination of soil-transmitted helminths.

PubMed

Ásbjörnsdóttir, Kristjana H; Means, Arianna R; Werkman, Marleen; Walson, Judd L

2017-10-01

Soil-transmitted helminths (STH) are endemic in 120 countries and are associated with substantial morbidity and loss of economic productivity. Although current WHO guidelines focus on morbidity control through mass drug administration (MDA), there is global interest in whether a strategy targeting disease elimination might be feasible in some settings. This review summarizes the prospects for switching from control to an elimination strategy. STH control efforts have reduced the intensity of infections in targeted populations with associated reductions in morbidity. However, adults are not frequently targeted and remain important reservoirs for reinfection of treated children. Recent modeling suggests that transmission interruption may be possible through expanded community-wide delivery of MDA, the feasibility of which has been demonstrated by other programs. However, these models suggest that high levels of coverage and compliance must be achieved. Potential challenges include the risk of prematurely dismantling STH programs and the potential increased risk of antihelminthic resistance. Elimination of STH may offer an opportunity to eliminate substantial STH-related morbidity while reducing resource needs of neglected tropical disease programs. Evidence from large community trials is needed to determine the feasibility of interrupting the transmission of STH in some geographic settings.

Feasibility of a prospective, randomised, open-label, international multicentre, phase III, non-inferiority trial to assess the safety of active surveillance for low risk ductal carcinoma in situ - The LORD study.

PubMed

Elshof, Lotte E; Tryfonidis, Konstantinos; Slaets, Leen; van Leeuwen-Stok, A Elise; Skinner, Victoria P; Dif, Nicolas; Pijnappel, Ruud M; Bijker, Nina; Rutgers, Emiel J Th; Wesseling, Jelle

2015-08-01

The current debate on overdiagnosis and overtreatment of screen-detected ductal carcinoma in situ (DCIS) urges the need for prospective studies to address this issue. A substantial number of DCIS lesions will never form a health hazard, particularly if it concerns non- to slow-growing low-grade DCIS. The LORD study aims to evaluate the safety of active surveillance in women with low-risk DCIS. This is a randomised, international multicentre, open-label, phase III non-inferiority trial, led by the Dutch Breast Cancer Research Group (BOOG 2014-04) and the European Organization for Research and Treatment of Cancer (EORTC-BCG 1401). Standard treatment will be compared to active surveillance in 1240 women aged ⩾ 45 years with asymptomatic, screen-detected, pure low-grade DCIS based on vacuum-assisted biopsies of microcalcifications only. Both study arms will be monitored with annual digital mammography for a period of 10 years. The primary end-point is 10-year ipsilateral invasive breast cancer free percentage. Secondary end-points include patient reported outcomes, diagnostic biopsy rate during follow-up, ipsilateral mastectomy rate and translational research. To explore interest in and feasibility of the LORD study we conducted a survey among EORTC and BOOG centres. A vast majority of EORTC and BOOG responding centres expressed interest in participation in the LORD study. The proposed study design is endorsed by nearly all centres. Copyright © 2015 The Authors. Published by Elsevier Ltd.. All rights reserved.

The Normal Fetal Pancreas.

PubMed

Kivilevitch, Zvi; Achiron, Reuven; Perlman, Sharon; Gilboa, Yinon

2017-10-01

The aim of the study was to assess the sonographic feasibility of measuring the fetal pancreas and its normal development throughout pregnancy. We conducted a cross-sectional prospective study between 19 and 36 weeks' gestation. The study included singleton pregnancies with normal pregnancy follow-up. The pancreas circumference was measured. The first 90 cases were tested to assess feasibility. Two hundred ninety-seven fetuses of nondiabetic mothers were recruited during a 3-year period. The overall satisfactory visualization rate was 61.6%. The intraobserver and interobserver variability had high interclass correlation coefficients of of 0.964 and 0.967, respectively. A cubic polynomial regression described best the correlation of pancreas circumference with gestational age (r = 0.744; P < .001) and significant correlations also with abdominal circumference and estimated fetal weight (Pearson r = 0.829 and 0.812, respectively; P < .001). Modeled pancreas circumference percentiles for each week of gestation were calculated. During the study period, we detected 2 cases with overgrowth syndrome and 1 case with an annular pancreas. In this study, we assessed the feasibility of sonography for measuring the fetal pancreas and established a normal reference range for the fetal pancreas circumference throughout pregnancy. This database can be helpful when investigating fetomaternal disorders that can involve its normal development. © 2017 by the American Institute of Ultrasound in Medicine.

[Laparoscopic cholecystectomy with transgastric gallbladder extraction].

PubMed

Jurczak, Florent

2011-11-01

To describe and evaluate a new cholecystectomy technique combining classical dissection with currently available mini-instrumentation (3 and 5 mm) and gallbladder removal through a short gastrotomy. After a feasibility study, we set up a protocol for this procedure using instrumentation currently available on the market. We performed 106 procedures, including 99 in a prospective study between January 2008 and July 2010. Cholecystectomy was performed with the described technique in 99 of 106 eligible patients (22 males and 77 females, mean age 45.8 years (range 18-77); median BMI 26.4 kg/m2 (range 22-36)). Forty-eight patients had at least one gallstone larger than 10 mm. There were no postoperative gastric complications and recovery was always rapid. This procedure is technically feasible, safe and reproducible. The results are good, with minimal abdominal wall trauma. Normal physical activity can be resumed rapidly with no risk of incisional hernia.

Red mud application in construction industry: review of benefits and possibilities

NASA Astrophysics Data System (ADS)

Lima, M. S. S.; Thives, L. P.; Haritonovs, V.; Bajars, K.

2017-10-01

Red mud is a waste originated in the processing of bauxite into aluminium, which properties of high alkalinity make it cumulatively stored, occupying increasing deforested areas. Annually, it is estimated that approximately 117 million tons of red mud are generated in the world, with no prospect of use, what represents an imminent risk of pollution prone to contamination. Nevertheless, environmental liabilities caused by red mud affect not only the environment, but also the companies responsible for the waste, which will be subject to highest fee payments. Although there are studies that prove the feasibility of using this solid waste in the constitution of ceramic materials, there are no large-scale applications. This study seeks to evaluate the possibilities of red mud application in construction industry, focusing into two main areas: cement production/ceramic material and road construction. Backgrounds from other researchers were taken into consideration and analysed according environmental, economic and technical feasibilities.

Mobile, real-time, and point-of-care augmented reality is robust, accurate, and feasible: a prospective pilot study.

PubMed

Kenngott, Hannes Götz; Preukschas, Anas Amin; Wagner, Martin; Nickel, Felix; Müller, Michael; Bellemann, Nadine; Stock, Christian; Fangerau, Markus; Radeleff, Boris; Kauczor, Hans-Ulrich; Meinzer, Hans-Peter; Maier-Hein, Lena; Müller-Stich, Beat Peter

2018-06-01

Augmented reality (AR) systems are currently being explored by a broad spectrum of industries, mainly for improving point-of-care access to data and images. Especially in surgery and especially for timely decisions in emergency cases, a fast and comprehensive access to images at the patient bedside is mandatory. Currently, imaging data are accessed at a distance from the patient both in time and space, i.e., at a specific workstation. Mobile technology and 3-dimensional (3D) visualization of radiological imaging data promise to overcome these restrictions by making bedside AR feasible. In this project, AR was realized in a surgical setting by fusing a 3D-representation of structures of interest with live camera images on a tablet computer using marker-based registration. The intent of this study was to focus on a thorough evaluation of AR. Feasibility, robustness, and accuracy were thus evaluated consecutively in a phantom model and a porcine model. Additionally feasibility was evaluated in one male volunteer. In the phantom model (n = 10), AR visualization was feasible in 84% of the visualization space with high accuracy (mean reprojection error ± standard deviation (SD): 2.8 ± 2.7 mm; 95th percentile = 6.7 mm). In a porcine model (n = 5), AR visualization was feasible in 79% with high accuracy (mean reprojection error ± SD: 3.5 ± 3.0 mm; 95th percentile = 9.5 mm). Furthermore, AR was successfully used and proved feasible within a male volunteer. Mobile, real-time, and point-of-care AR for clinical purposes proved feasible, robust, and accurate in the phantom, animal, and single-trial human model shown in this study. Consequently, AR following similar implementation proved robust and accurate enough to be evaluated in clinical trials assessing accuracy, robustness in clinical reality, as well as integration into the clinical workflow. If these further studies prove successful, AR might revolutionize data access at patient bedside.

Percutaneous intraductal radiofrequency ablation for clearance of occluded metal stent in malignant biliary obstruction: feasibility and early results.

PubMed

Pai, Madhava; Valek, Vlastimil; Tomas, Andrasina; Doros, Attila; Quaretti, Pietro; Golfieri, Rita; Mosconi, Cristina; Habib, Nagy

2014-02-01

The major complication occurring with biliary stents is stent occlusion, frequently seen because of tumour in-growth, epithelial hyperplasia, and sludge deposits, resulting in recurrent jaundice and cholangitis. We report a prospective study with the results of first in man percutaneous intraductal radiofrequency (RF) ablation to clear the blocked metal stents in patients with malignant biliary obstruction using a novel bipolar RF catheter. Nine patients with malignant biliary obstruction and blocked metal stents were included. These patients underwent intraductal biliary RF ablation through the blocked metal stent following external biliary decompression with an internal-external biliary drainage. All nine patients had their stent patency restored successfully without the use of secondary stents. Following this intervention, there was no 30-day mortality, haemorrhage, bile duct perforation, bile leak, or pancreatitis. Of the nine patients, six are alive and three patients are dead with a median follow-up of 122 (range 50-488) days and a median stent patency of 102.5 (range 50-321) days. Six patients had their stent patent at the time of last follow-up or death. Three patients with stent blockage at 321, 290, and 65 days postprocedure underwent percutaneous transhepatic drain insertion and repeat ablation. In this selective group of patients, it appears that this new approach is safe and feasible. Efficacy remains to be proven in future, randomized, prospective studies.

Longitudinal molecular characterization of endoscopic specimens from colorectal lesions

PubMed Central

Minarikova, Petra; Benesova, Lucie; Halkova, Tereza; Belsanova, Barbora; Suchanek, Stepan; Cyrany, Jiri; Tuckova, Inna; Bures, Jan; Zavoral, Miroslav; Minarik, Marek

2016-01-01

AIM: To compare molecular profiles of proximal colon, distal colon and rectum in large adenomas, early and late carcinomas. To assess feasibility of testing directed at molecular markers from this study in routine clinical practice. METHODS: A prospective 3-year study has resulted in the acquisition of samples from 159 large adenomas and 138 carcinomas along with associated clinical parameters including localization, grade and histological type for adenomas and localization and stage for carcinomas. A complex molecular phenotyping has been performed using multiplex ligation-dependent probe amplification technique for the evaluation of CpG-island methylator phenotype (CIMP), PCR fragment analysis for detection of microsatellite instability and denaturing capillary electrophoresis for sensitive detection of somatic mutations in KRAS, BRAF, TP53 and APC genes. RESULTS: Molecular types according to previously introduced Jass classification have been evaluated for large adenomas and early and late carcinomas. An increase in CIMP+ type, eventually accompanied with KRAS mutations, was notable between large adenomas and early carcinomas. As expected, the longitudinal observations revealed a correlation of the CIMP+/BRAF+ type with proximal location. CONCLUSION: Prospective molecular classification of tissue specimens is feasible in routine endoscopy practice. Increased frequency of some molecular types corresponds to the developmental stages of colorectal tumors. As expected, a clear distinction is notable for tumors located in proximal colon supposedly arising from the serrated (methylation) pathway. PMID:27239120

Prospective feasibility analysis of a novel off-line approach for MR-guided radiotherapy.

PubMed

Bostel, Tilman; Pfaffenberger, Asja; Delorme, Stefan; Dreher, Constantin; Echner, Gernot; Haering, Peter; Lang, Clemens; Splinter, Mona; Laun, Frederik; Müller, Marco; Jäkel, Oliver; Debus, Jürgen; Huber, Peter E; Sterzing, Florian; Nicolay, Nils H

2018-05-01

The present work aimed to analyze the feasibility of a shuttle-based MRI-guided radiation therapy (MRgRT) in the treatment of pelvic malignancies. 20 patients with pelvic malignancies were included in this prospective feasibility analysis. Patients underwent daily MRI in treatment position prior to radiotherapy at the German Cancer Research Center. Positional inaccuracies, time and patient compliance were assessed for the application of off-line MRgRT. In 78% of applied radiation fractions, MR imaging for position verification could be performed without problems. Additionally, treatment-related side effects and reduced patient compliance were only responsible for omission of MRI in 9% of radiation fractions. The study workflow took a median time of 61 min (range 47-99 min); duration for radiotherapy alone was 13 min (range 7-26 min). Patient positioning, MR imaging and CT imaging including patient repositioning and the shuttle transfer required median times of 10 min (range 7-14 min), 26 min (range 15-60 min), 5 min (range 3-8 min) and 8 min (range 2-36 min), respectively. To assess feasibility of shuttle-based MRgRT, the reference point coordinates for the x, y and z axis were determined for the MR images and CT obtained prior to the first treatment fraction and correlated with the coordinates of the planning CT. In our dataset, the median positional difference between MR imaging and CT-based imaging based on fiducial matching between MR and CT imaging was equal to or less than 2 mm in all spatial directions. The limited space in the MR scanner influenced patient selection, as the bore of the scanner had to accommodate the immobilization device and the constructed stereotactic frame. Therefore, obese, extremely muscular or very tall patients could not be included in this trial in addition to patients for whom exposure to MRI was generally judged inappropriate. This trial demonstrated for the first time the feasibility and patient compliance of a shuttle-based off-line approach to MRgRT of pelvic malignancies.

The Role of Telemedicine in Auditory Rehabilitation: A Systematic Review

PubMed Central

Bush, Matthew L.; Thompson, Robin; Irungu, Catherine; Ayugi, John

2016-01-01

Objective The purpose of this study was to assess the feasibility and effectiveness of live telemedicine applications in hearing amplification and cochlear implantation. Data Sources and Study Selection A systematic search was performed in PubMed, MEDLINE, PsychINFO, CINALH, and Web of Science to identify peer-reviewed research. Inclusion criteria were titles containing words from the search terms (1) audiology, otolaryngology, and hearing impairment, (2) rehabilitative methods, and (3) telemedicine. Exclusion criteria were 1) non-English articles, and 2) non-original research. Data Extraction and Synthesis Twelve eligible studies were identified. The studies employed a prospective design in nine of the articles and retrospective case series in three. The use of telemedicine for the provision of cochlear implant services was examined in eight of the articles and with hearing aids in four of the articles. The types of services include intraoperative cochlear implant telemetry; implant programming and assessment of electrode-specific measures and speech recognition after implantation. Hearing aid programming and remote gain assessments were also reported. Many studies assess patient and provider satisfaction along with encounter time comparison. The studies occurred from 2009–2014 and took place in seven countries. Conclusions This review examined the feasibility of remote telemedicine connection to provide in auditory rehabilitation services through hearing aids and cochlear implants. There are significant concerns regarding Internet bandwidth limitations for remote clinics. There is a paucity of research examining reimbursement and cost-effectiveness for services. Further prospective research investigating cost-effectiveness and bandwidth limitations is warranted to assess long-term sustainability of remote audiological rehabilitative service delivery. PMID:27755363

Sentinel Lymph Node Detection Using Carbon Nanoparticles in Patients with Early Breast Cancer

PubMed Central

Lu, Jianping; Zeng, Yi; Chen, Xia; Yan, Jun

2015-01-01

Purpose Carbon nanoparticles have a strong affinity for the lymphatic system. The purpose of this study was to evaluate the feasibility of sentinel lymph node biopsy using carbon nanoparticles in early breast cancer and to optimize the application procedure. Methods Firstly, we performed a pilot study to demonstrate the optimized condition using carbon nanoparticles for sentinel lymph nodes (SLNs) detection by investigating 36 clinically node negative breast cancer patients. In subsequent prospective study, 83 patients with clinically node negative breast cancer were included to evaluate SLNs using carbon nanoparticles. Another 83 SLNs were detected by using blue dye. SLNs detection parameters were compared between the methods. All patients irrespective of the SLNs status underwent axillary lymph node dissection for verification of axillary node status after the SLN biopsy. Results In pilot study, a 1 ml carbon nanoparticles suspension used 10–15min before surgery was associated with the best detection rate. In subsequent prospective study, with carbon nanoparticles, the identification rate, accuracy, false negative rate was 100%, 96.4%, 11.1%, respectively. The identification rate and accuracy were 88% and 95.5% with 15.8% of false negative rate using blue dye technique. The use of carbon nanoparticles suspension showed significantly superior results in identification rate (p = 0.001) and reduced false-negative results compared with blue dye technique. Conclusion Our study demonstrated feasibility and accuracy of using carbon nanoparticles for SLNs mapping in breast cancer patients. Carbon nanoparticles are useful in SLNs detection in institutions without access to radioisotope. PMID:26296136

Feasibility of aerosol drug delivery to sleeping infants: a prospective observational study.

PubMed

Amirav, Israel; Newhouse, Michael T; Luder, Anthony; Halamish, Asaf; Omar, Hamza; Gorenberg, Miguel

2014-03-26

Delivery of inhaled medications to infants is usually very demanding and is often associated with crying and mask rejection. It has been suggested that aerosol administration during sleep may be an attractive alternative. Previous studies in sleeping children were disappointing as most of the children awoke and rejected the treatment. The SootherMask (SM) is a new, gentle and innovative approach for delivering inhaled medication to infants and toddlers. The present pilot study describes the feasibility of administering inhaled medications during sleep using the SM. Prospective observational study. Out patients. 13 sleeping infants with recurrent wheezing who regularly used pacifiers and were <12 months old. Participants inhaled technetium99mDTPA-labelled normal saline aerosol delivered via a Respimat Soft Mist Inhaler (SMI) (Boehringer-Ingelheim, Germany) and SM + InspiraChamber (IC; InspiRx Inc, New Jersey, USA). The two major outcomes were the acceptability of the treatment and the lung deposition (per cent of emitted dose). All infants who fulfilled the inclusion criteria successfully received the SM treatment during sleep without difficulty. Mean lung deposition (±SD) averaged 1.6±0.5% in the right lung. This study demonstrated that the combination of Respimat, IC and SM was able to administer aerosol therapy to all the sleeping infants who were regular pacifier users with good lung deposition. Administration of aerosols during sleep is advantageous since all the sleeping children accepted the mask and ensuing aerosol therapy under these conditions, in contrast to previous studies in which there was frequent mask rejection using currently available devices. NCT01120938.

Treatment of nulliparous women with severe fear of childbirth via the Internet: a feasibility study.

PubMed

Nieminen, Katri; Andersson, Gerhard; Wijma, Barbro; Ryding, Elsa-Lena; Wijma, Klaas

2016-01-01

The aim of the present study was to test the feasibility of Internet interventions among nulliparous women suffering from severe fear of childbirth (FOC) by means of an Internet-delivered therapist-supported self-help program based on cognitive behavioral therapy (ICBT). Prospective, longitudinal cohort study. A feasibility study of an ICBT program for the treatment of severe FOC in pregnant women. Twenty-eight Swedish-speaking nulliparous women with severe FOC recruited via a project home page from January 2012 to December 2013. The main components of the ICBT program for the treatment of severe FOC comprised psycho-education, breathing retraining, cognitive restructuring, imaginary exposure, in vivo exposure and relapse prevention. The study participants were anonymously self-recruited over the Internet, interviewed by telephone and then enrolled. All participants were offered 8 weeks of treatment via the Internet. Participants reported their homework weekly, submitted measurements of their fear and received feedback from a therapist via a secure online contact management system. Level of FOC measured with the Wijma Delivery Expectancy/Experience Questionnaire (W-DEQ A) during screening at enrollment and weekly during the treatment (W-DEQ version A), and after the delivery (W-DEQ version B). A statistically significant (p < 0.0005) decrease of FOC [W-DEQ sum score decreased pre to post-therapy, with a large effect size (Cohen's d = 0.95)]. The results of this feasibility study suggest that ICBT has potential in the treatment of severe FOC during pregnancy in motivated nulliparous women. The results need to be confirmed by randomized controlled studies.

Acceptability and feasibility of HIV testing in general medicine by ELISA or rapid test from finger-stick whole blood.

PubMed

Demorat, Hubert; Lopes, Amanda; Chopin, Dorothée; Delcey, Véronique; Clevenbergh, Philippe; Simoneau, Guy; Evans, John; Mouly, Stéphane; Bergmann, Jean-François; Sellier, Pierre

2018-02-01

Guidelines recommend routine universal HIV testing in adults to reduce the pool of infected patients unaware of their status, without specific recommendations concerning the method. We compared acceptability and feasibility of HIV testing by ELISA tests or rapid tests from finger-stick whole blood. Prospective randomized multi-center study comparing acceptability and feasibility of routine universal HIV testing by ELISA tests, with a charge, subsequently reimbursed by Social Security for affiliated patients, or rapid tests from finger-stick whole blood, without any charge from the patients or the general practitioner for the study. A single investigator performed all interventions. After consent, all adults (18-70 years old) consulting their general practitioner in Paris, France, unaware of their status, were enrolled. Testing was performed immediately for the patients in the rapid test arm; a prescription was given for testing in a lab for the patients in the ELISA arm. The primary endpoint was acceptability of each method. The secondary endpoint was feasibility of each method, assessed one month after the consultation. Two hundred and seventy patients were enrolled: 133 patients in the ELISA arm, 137 in the rapid test arm. Acceptability of the rapid test (92%) was higher than that of the ELISA (63.9%), P<0.0001. Feasibility of the rapid test (100%) was higher than that of the ELISA (50.5%), P<0.0001. A center effect was shown concerning feasibility of ELISA but not concerning feasibility of rapid tests. Rapid testing from finger-stick whole blood is more acceptable and feasible than ELISA for routine universal HIV testing. A larger use of rapid tests, ideally free of charge, by general practitioners could reduce the pool of infected patients unaware of their status. Copyright © 2018 Elsevier Masson SAS. All rights reserved.

Topical corticosteroid phobia in atopic dermatitis: International feasibility study of the TOPICOP score.

PubMed

Stalder, J-F; Aubert, H; Anthoine, E; Futamura, M; Marcoux, D; Morren, M-A; Trzeciak, M; Szalai, Z; Veres, K; Deleuran, M; Vestergaard, C; Boralevi, F; Chu, C-Y; De Raeve, L; Svensson, Å; Fölster-Holst, R; Buchner, M; Takaoka, R; Aoki, V; Chernyshov, P; Chernyshova, L; Murrell, D F; Zhao, C; Mckinster, C D; Von Kobyletzky, L; Eichenfield, L; Totri, C; Lio, P; Seneschal, J; Moret, L; Barbarot, S

2017-11-01

Adherence to topical corticosteroids (TCS) is essential for the effective treatment of atopic dermatitis but can be limited by concerns about their use. This study examined the feasibility of applying the validated TOPICOP score for assessing TCS phobia across different countries. This was a prospective multicentre feasibility study conducted in 21 hospitals in 17 countries. Patients >3 months of age with atopic dermatitis or their parents or legal representatives completed a validated translation of the TOPICOP questionnaire in the country's native language. Respondents also completed questionnaires collecting opinions about the feasibility and acceptability of the TOPICOP questionnaire. A total of 1564 participants in 15 countries were included in the analysis. 81% of respondents considered the questions clear or very clear, and 79% reported that it took less than 5 minutes to complete. Each of the individual items in the TOPICOP questionnaire was considered to be not at all difficult to answer by 49% to 74% of participants. The mean global TOPICOP score was 44.7%±20.5. Mean TOPICOP subscores were 37.0±22.8% for knowledge and beliefs, 54.7±27.8% for fears and 50.1±29.1% for behaviours. Global scores and subscores differed between countries, although the subscores did not always vary in parallel, suggesting different levels of TCS phobia and different drivers for each country. The TOPICOP score can be feasibly applied across countries and may therefore be useful for obtaining qualitative and quantitative data from international studies and for adapting patient education and treatment. © 2017 EAACI and John Wiley and Sons A/S. Published by John Wiley and Sons Ltd.

Prospective multi-center study of an automatic online seizure detection system for epilepsy monitoring units.

PubMed

Fürbass, F; Ossenblok, P; Hartmann, M; Perko, H; Skupch, A M; Lindinger, G; Elezi, L; Pataraia, E; Colon, A J; Baumgartner, C; Kluge, T

2015-06-01

A method for automatic detection of epileptic seizures in long-term scalp-EEG recordings called EpiScan will be presented. EpiScan is used as alarm device to notify medical staff of epilepsy monitoring units (EMUs) in case of a seizure. A prospective multi-center study was performed in three EMUs including 205 patients. A comparison between EpiScan and the Persyst seizure detector on the prospective data will be presented. In addition, the detection results of EpiScan on retrospective EEG data of 310 patients and the public available CHB-MIT dataset will be shown. A detection sensitivity of 81% was reached for unequivocal electrographic seizures with false alarm rate of only 7 per day. No statistical significant differences in the detection sensitivities could be found between the centers. The comparison to the Persyst seizure detector showed a lower false alarm rate of EpiScan but the difference was not of statistical significance. The automatic seizure detection method EpiScan showed high sensitivity and low false alarm rate in a prospective multi-center study on a large number of patients. The application as seizure alarm device in EMUs becomes feasible and will raise the efficiency of video-EEG monitoring and the safety levels of patients. Copyright © 2014 International Federation of Clinical Neurophysiology. Published by Elsevier Ireland Ltd. All rights reserved.

Feasibility and radiation dose of high-pitch acquisition protocols in patients undergoing dual-source cardiac CT.

PubMed

Sommer, Wieland H; Albrecht, Edda; Bamberg, Fabian; Schenzle, Jan C; Johnson, Thorsten R; Neumaier, Klement; Reiser, Maximilian F; Nikolaou, Konstatin

2010-12-01

The objective of this study was to compare image quality and radiation dose between high-pitch and established retrospectively and prospectively gated cardiac CT protocols using an Alderson-Rando phantom and a set of patients. An anthropomorphic Alderson-Rando phantom equipped with thermoluminiscent detectors and a set of clinical patients underwent the following cardiac CT protocols: high-pitch acquisition (pitch 3.4), prospectively triggered acquisition, and retrospectively gated acquisition (pitch 0.2). For patients with sinus rhythm below 65 beats per minute (bpm), high-pitch protocol was used, whereas for patients in sinus rhythm between 65 and 100 bpm, prospective triggering was used. Patients with irregular heart rates or heart rates of ≥ 100 bpm, were examined using retrospectively gated acquisition. Evaluability of coronary artery segments was determined, and effective radiation dose was derived from the phantom study. In the phantom study, the effective radiation dose as determined with thermoluminescent detector (TLD) measurements was lowest in the high-pitch acquisition (1.21, 3.12, and 11.81 mSv, for the high-pitch, the prospectively triggered, and the retrospectively gated acquisition, respectively). There was a significant difference with respect to the percentage of motion-free coronary artery segments (99%, 87%, and 92% for high-pitch, prospectively triggered, and retrospectively gated, respectively (p < 0.001), whereas image noise was lowest for the high-pitch protocol (p < 0.05). High-pitch scans have the potential to reduce radiation dose up to 61.2% and 89.8% compared with prospectively triggered and retrospectively gated scans. High-pitch protocols lead to excellent image quality when used in patients with stable heart rates below 65 bpm.

Current progress and future prospect of microalgal biomass harvest using various flocculation technologies.

PubMed

Wan, Chun; Alam, Md Asraful; Zhao, Xin-Qing; Zhang, Xiao-Yue; Guo, Suo-Lian; Ho, Shih-Hsin; Chang, Jo-Shu; Bai, Feng-Wu

2015-05-01

Microalgae have been extensively studied for the production of various valuable products. Application of microalgae for the production of renewable energy has also received increasing attention in recent years. However, high cost of microalgal biomass harvesting is one of the bottlenecks for commercialization of microalgae-based industrial processes. Considering harvesting efficiency, operation economics and technological feasibility, flocculation is a superior method to harvest microalgae from mass culture. In this article, the latest progress of various microalgal cell harvesting methods via flocculation is reviewed with the emphasis on the current progress and prospect in environmentally friendly bio-based flocculation. Harvesting microalgae through bio-based flocculation is a promising component of the low-cost microalgal biomass production technology. Copyright © 2014 Elsevier Ltd. All rights reserved.

Comparison of Combined Endoscopic Ultrasonography and Endoscopic Secretin Testing With the Traditional Secretin Pancreatic Function Test in Patients With Suspected Chronic Pancreatitis: A Prospective Crossover Study.

PubMed

Kothari, Darshan; Ketwaroo, Gyanprakash; Sawhney, Mandeep S; Freedman, Steven D; Sheth, Sunil G

2017-07-01

We aimed to determine the feasibility and accuracy of a combined endoscopic ultrasonography (EUS) with a shortened pancreatic function testing (sEUS) for structural and functional assessment using a single instrument in patients with suspected chronic pancreatitis (CP). We completed a prospective crossover study, enrolling patients with suspected CP. Patients who underwent both traditional 1-hour secretin pancreatic function test (sPFT) and sEUS were included in the analysis. We compared study results for test concordance and for correlation of peak bicarbonate concentrations. Eleven (64.7%) of 17 patients had concordant sPFT and sEUS findings when the cutoff for peak bicarbonate was 80 mEq/L. Six patients had discordant findings with a negative sPFT and positive sEUS. This poor concordance suggests that sEUS is an unreliable functional test. Lowering the sEUS cutoff to 70 mEq/L resulted in improved concordance (64.7% vs 70.6%). Finally, there was no significant correlation between peak bicarbonate concentrations (r = 0.47; 95% confidence interval, -0.02 to 0.79) in these 2 functional tests. We demonstrate poor concordance between sPFT and sEUS suggesting that a combined shortened functional and structural test using a single instrument may not be a feasible test for diagnosis of suspected CP when a cutoff of 80 mEq/L is used.

Prospective Validation of Objective Prognostic Score for Advanced Cancer Inpatients in South Korea: A Multicenter Study.

PubMed

Yoon, Seok Joon; Suh, Sang-Yeon; Lee, Yong Joo; Park, Jeanno; Hwang, Sunwook; Lee, Sanghee Shiny; Ahn, Hong Yup; Koh, Su-Jin; Park, Keon Uk

2017-01-01

Objective Prognostic Score (OPS) was developed as an easy and simple prognosticating tool in South Korea. It has been validated retrospectively in a single center in South Korea. We aimed to validate the OPS prospectively for advanced cancer inpatients in South Korea using a multicenter study. This was a prospective cohort study. We enrolled 243 advanced cancer patients admitted in five palliative care units in South Korea from May 2013 till March 2015. Seven members of the Korean Palliative Medicine Research Network who are experts of palliative care led the study. Clinical variables (dyspnea/anorexia/performance status) and laboratory variables (total leukocyte counts/serum total bilirubin/serum creatinine/lactate dehydrogenase) were collected at the enrollment. Survival time was calculated as days from enrollment to death during admission. A total of 217 patients were included in the final analysis (feasibility: 89.3%). Survival time of the higher OPS group (OPS ≥3) and the lower OPS group (OPS <3) was 10.0 (95% confidence interval (CI) 7.72-12.28) days and 32.0 (95% CI 25.44-38.56) days, respectively. There were significant differences between the 2 groups (p < 0.001). Overall accuracy of OPS ≥3 for predicting survival less than three weeks was 71.0%. OPS was successfully validated using a prospective multicenter study in South Korea. It is a useful method to predict three-week survival of Korean inpatients with advanced cancer.

Intraoperative application of geometric three-dimensional mitral valve assessment package: a feasibility study.

PubMed

Mahmood, Feroze; Karthik, Swaminathan; Subramaniam, Balachundhar; Panzica, Peter J; Mitchell, John; Lerner, Adam B; Jervis, Karinne; Maslow, Andrew D

2008-04-01

To study the feasibility of using 3-dimensional (3D) echocardiography in the operating room for mitral valve repair or replacement surgery. To perform geometric analysis of the mitral valve before and after repair. Prospective observational study. Academic, tertiary care hospital. Consecutive patients scheduled for mitral valve surgery. Intraoperative reconstruction of 3D images of the mitral valve. One hundred and two patients had 3D analysis of their mitral valve. Successful image reconstruction was performed in 93 patients-8 patients had arrhythmias or a dilated mitral valve annulus resulting in significant artifacts. Time from acquisition to reconstruction and analysis was less than 5 minutes. Surgeon identification of mitral valve anatomy was 100% accurate. The study confirms the feasibility of performing intraoperative 3D reconstruction of the mitral valve. This data can be used for confirmation and communication of 2-dimensional data to the surgeons by obtaining a surgical view of the mitral valve. The incorporation of color-flow Doppler into these 3D images helps in identification of the commissural or perivalvular location of regurgitant orifice. With improvements in the processing power of the current generation of echocardiography equipment, it is possible to quickly acquire, reconstruct, and manipulate images to help with timely diagnosis and surgical planning.

Electronic patient-reported outcomes from home in patients recovering from major gynecologic cancer surgery: A prospective study measuring symptoms and health-related quality of life.

PubMed

Cowan, Renee A; Suidan, Rudy S; Andikyan, Vaagn; Rezk, Youssef A; Einstein, M Heather; Chang, Kaity; Carter, Jeanne; Zivanovic, Oliver; Jewell, Elizabeth J; Abu-Rustum, Nadeem R; Basch, Ethan; Chi, Dennis S

2016-11-01

We previously reported on the feasibility of a Web-based system to capture patient-reported outcomes (PROs) in the immediate postoperative period. The purpose of this study was to update the experience of these patients and assess patient and provider satisfaction and feedback regarding the system. This is a prospective cohort study of patients scheduled to undergo laparotomy for presumed gynecologic malignancy. Patients completed a Web-based Symptom Tracking and Reporting (STAR) questionnaire preoperatively and weekly during a 6-week postoperative period. Email alerts were sent to study nurses when concerning patient responses were entered. The patient and the nurse assessments of STAR's usefulness were measured via an exit survey. The study enrolled 96 eligible patients. Of these, 71 patients (74%) completed at least four of seven total sessions. Of the patients who completed the exit satisfaction survey, 98% found STAR easy to use; 84% found it useful; and 82% would recommend it to other patients. Despite positive feedback from patients, clinical personnel found that the STAR system increased their current workload without enhancing patient care. Application of an electronic program for PROs in those recovering from major gynecologic cancer surgery is feasible, and acceptable to most patients. While most clinicians did not find STAR clinically helpful, the majority of patients reported a positive experience with the system and would recommend its use. The program helped many patients feel more empowered in their postoperative recovery. Copyright © 2016 Elsevier Inc. All rights reserved.

Video recording of neonatal resuscitation: A feasibility study to inform widespread adoption

PubMed Central

Shivananda, Sandesh; Twiss, Jennifer; el-Gouhary, Enas; el-Helou, Salhab; Williams, Connie; Murthy, Prashanth; Suresh, Gautham

2017-01-01

AIM To determine the feasibility of introducing video recording (VR) of neonatal resuscitation (NR) in a perinatal centre. METHODS This was a prospective cohort quality improvement study on preterm infants and their caregivers. Based on evidence and experience of other centers using VR intervention, a contextually relevant implementation and evaluation strategy was designed in the planning phase. The components of intervention were pre-resuscitation team huddle, VR of NR and video debriefing (VD), all occurring on the same day. Various domains of feasibility and sustainability as well as feasibility criteria were predefined. Data for analysis was collected using quantitative and qualitative methods. RESULTS Seventy-one caregivers participated in VD of 14 NRs facilitated by six trained instructors. Ninety-one percent of caregivers perceived enhanced learning and patient safety and, 48 issues were identified related to policy, caregiver roles, and latent safety threats. Ninety percent of caregivers expressed their willingness to participate in VD activity and supported the idea of integrating it into a resuscitation team routine. Eighty-three percent and 50% of instructors expressed satisfaction with video review software and quality of audio VR. No issues about maintenance of infant or caregivers’ confidentiality and erasure of videos were reported. Criteria for feasibility were met (refusal rate of < 10%, VR performed on > 50% of occasions, and < 20% caregivers’ perceiving a negative impact on team performance). Necessary adaptations to enhance sustainability were identified. CONCLUSION VR of NR as a standard of care quality assurance activity to enhance caregivers’ learning and create opportunities that improve patient safety is feasible. Despite its complexity with inherent challenges in implementation, the intervention was acceptable, implementable, and potentially sustainable with adaptations. PMID:28224098

What Fermenter?

ERIC Educational Resources Information Center

Terry, John

1987-01-01

Discusses the feasibility of using fermenters in secondary school laboratories. Includes discussions of equipment, safety, and computer interfacing. Describes how a simple fermenter could be used to simulate large-scale processes. Concludes that, although teachers and technicians will require additional training, the prospects for biotechnology in…

A Prospective Study of Loss of Consciousness in Epilepsy Using Virtual Reality Driving Simulation and Other Video Games

PubMed Central

Yang, Li; Morland, Thomas B.; Schmits, Kristen; Rawson, Elizabeth; Narasimhan, Poojitha; Motelow, Joshua E.; Purcaro, Michael J.; Peng, Kathy; Raouf, Saned; DeSalvo, Matthew N.; Oh, Taemin; Wilkerson, Jerome; Bod, Jessica; Srinivasan, Aditya; Kurashvili, Pimen; Anaya, Joseph; Manza, Peter; Danielson, Nathan; Ransom, Christopher B.; Huh, Linda; Elrich, Susan; Padin-Rosado, Jose; Naidu, Yamini; Detyniecki, Kamil; Hamid, Hamada; Fattahi, Pooia; Astur, Robert; Xiao, Bo; Duckrow, Robert B.; Blumenfeld, Hal

2010-01-01

Patients with epilepsy are at risk of traffic accidents when they have seizures while driving. However, driving is an essential part of normal daily life in many communities, and depriving patients of driving privileges can have profound consequences for their economic and social well being. In the current study, we collected ictal performance data from a driving simulator and two other video games in patients undergoing continuous video/EEG monitoring. We captured 22 seizures in 13 patients and found that driving impairment during seizures differed both in terms of magnitude and character, depending on the seizure type. Our study documents the feasibility of the prospective study of driving and other behaviors during seizures through the use of computer-based tasks. This methodology may be applied to further describe differential driving impairment in specific types of seizures and to gain data on anatomical networks disrupted in seizures that impair consciousness and driving safety. PMID:20537593

Haptic-Based Neurorehabilitation in Poststroke Patients: A Feasibility Prospective Multicentre Trial for Robotics Hand Rehabilitation

PubMed Central

Daud Albasini, Omar A.; Oboe, Roberto; Tonin, Paolo; Paolucci, Stefano; Sandrini, Giorgio; Piron, Lamberto

2013-01-01

Background. Haptic robots allow the exploitation of known motor learning mechanisms, representing a valuable option for motor treatment after stroke. The aim of this feasibility multicentre study was to test the clinical efficacy of a haptic prototype, for the recovery of hand function after stroke. Methods. A prospective pilot clinical trial was planned on 15 consecutive patients enrolled in 3 rehabilitation centre in Italy. All the framework features of the haptic robot (e.g., control loop, external communication, and graphic rendering for virtual reality) were implemented into a real-time MATLAB/Simulink environment, controlling a five-bar linkage able to provide forces up to 20 [N] at the end effector, used for finger and hand rehabilitation therapies. Clinical (i.e., Fugl-Meyer upper extremity scale; nine hold pegboard test) and kinematics (i.e., time; velocity; jerk metric; normalized jerk of standard movements) outcomes were assessed before and after treatment to detect changes in patients' motor performance. Reorganization of cortical activation was detected in one patient by fMRI. Results and Conclusions. All patients showed significant improvements in both clinical and kinematic outcomes. Additionally, fMRI results suggest that the proposed approach may promote a better cortical activation in the brain. PMID:24319496

Feasibility of FDG-PET in myocarditis: Comparison to CMR using integrated PET/MRI.

PubMed

Nensa, Felix; Kloth, Julia; Tezgah, Ercan; Poeppel, Thorsten D; Heusch, Philipp; Goebel, Juliane; Nassenstein, Kai; Schlosser, Thomas

2018-06-01

Besides cardiac sarcoidosis, FDG-PET is rarely used in the diagnosis of myocardial inflammation, while cardiac MRI (CMR) is the actual imaging reference for the workup of myocarditis. Using integrated PET/MRI in patients with suspected myocarditis, we prospectively compared FDG-PET to CMR and the feasibility of integrated FDG-PET/MRI in myocarditis. A total of 65 consecutive patients with suspected myocarditis were prospectively assessed using integrated cardiac FDG-PET/MRI. Studies comprised T2-weighted imaging, late gadolinium enhancement (LGE), and simultaneous PET acquisition. Physiological glucose uptake in the myocardium was suppressed using dietary preparation. FDG-PET/MRI was successful in 55 of 65 enrolled patients: two patients were excluded due to claustrophobia and eight patients due to failed inhibition of myocardial glucose uptake. Compared with CMR (LGE and/or T2), sensitivity and specificity of PET was 74% and 97%. Overall spatial agreement between PET and CMR was κ = 0.73. Spatial agreement between PET and T2 (κ = 0.75) was higher than agreement between PET and LGE (κ = 0.64) as well as between LGE and T2 (κ = 0.56). In patients with suspected myocarditis, FDG-PET is in good agreement with CMR findings.

Haptic-based neurorehabilitation in poststroke patients: a feasibility prospective multicentre trial for robotics hand rehabilitation.

PubMed

Turolla, Andrea; Daud Albasini, Omar A; Oboe, Roberto; Agostini, Michela; Tonin, Paolo; Paolucci, Stefano; Sandrini, Giorgio; Venneri, Annalena; Piron, Lamberto

2013-01-01

Background. Haptic robots allow the exploitation of known motor learning mechanisms, representing a valuable option for motor treatment after stroke. The aim of this feasibility multicentre study was to test the clinical efficacy of a haptic prototype, for the recovery of hand function after stroke. Methods. A prospective pilot clinical trial was planned on 15 consecutive patients enrolled in 3 rehabilitation centre in Italy. All the framework features of the haptic robot (e.g., control loop, external communication, and graphic rendering for virtual reality) were implemented into a real-time MATLAB/Simulink environment, controlling a five-bar linkage able to provide forces up to 20 [N] at the end effector, used for finger and hand rehabilitation therapies. Clinical (i.e., Fugl-Meyer upper extremity scale; nine hold pegboard test) and kinematics (i.e., time; velocity; jerk metric; normalized jerk of standard movements) outcomes were assessed before and after treatment to detect changes in patients' motor performance. Reorganization of cortical activation was detected in one patient by fMRI. Results and Conclusions. All patients showed significant improvements in both clinical and kinematic outcomes. Additionally, fMRI results suggest that the proposed approach may promote a better cortical activation in the brain.

Feasibility of portable sleep monitors to detect obstructive sleep apnea (OSA) in a vulnerable urban population.

PubMed

Nickerson, Jillian; Lee, Euny; Nedelman, Michael; Aurora, R Nisha; Krieger, Ana; Horowitz, Carol R

2015-01-01

Portable sleep monitors may offer a convenient method to expand detection of obstructive sleep apnea (OSA), yet few studies have evaluated this technology in vulnerable populations. We therefore aimed to assess the feasibility and acceptability of portable sleep monitors for detection of OSA in a prediabetic, urban minority population. We recruited a convenience sample of participants at their 12-month follow-up for a community-partnered, peer-led lifestyle intervention aimed to prevent diabetes in prediabetic and overweight patients in this prospective mixed-methods pilot study. All participants wore portable sleep monitors overnight at home. We qualitatively explored perceptions about OSA and portable monitors in a subset of participants. We tested 72 people, predominantly non-White, female, Spanish speaking, uninsured, and of low income. Use of portable sleep monitors was feasible: 100% of the monitors were returned and all participants received results. We detected OSA in 49% (defined as an Apnea-Hypopnea Index [AHI] >5) and moderate-severe OSA in 14% (AHI >15) requiring treatment in 14%. In 21 qualitative interviews, participants supported increased use of portable sleep monitors in their community, were appropriately concerned that OSA could cause progression to diabetes, and thought weight loss could prevent or improve OSA. Portable sleep monitors may represent a feasible method for detecting OSA in high-risk urban minority populations. © Copyright 2015 by the American Board of Family Medicine.

Feasibility and acceptance of a pharmacist-run tele-oncology service for chemotherapy-induced nausea and vomiting in ambulatory cancer patients.

PubMed

Yap, Kevin Y-L; Low, Hui X; Koh, Ken S; Un, Matthew; Shih, Vivianne; Chan, Alexandre

2013-05-01

The use of telemedicine for cancer patients is limited, particularly in Asia. These patients need to be monitored because more are being treated as outpatients, so that any treatment-related side effects can be managed. We assessed the feasibility and acceptance of a pharmacist-run tele-oncology service to monitor chemotherapy-induced nausea and vomiting (CINV) in ambulatory cancer patients. A single-center, prospective study was conducted at a local cancer center. Patients' CINV symptoms were monitored through short message service (SMS) for 5 days post-chemotherapy. Feasibility was measured by patients' adherence to the service, patient satisfaction, and number of pharmacist interventions. Acceptance was measured by the accrual rate. The accrual rate was 37.6% (68/181 patients). Sixty patients (median age, 49.5 years) completed the study. Overall adherence was 73.3%. The majority (90.0%) were comfortable with the duration of SMS monitoring, especially adherent patients (95.5% versus 75.0%, p=0.038). Over half (61.7%) found the SMS advice useful. Twenty-two intervention calls were made by pharmacists for uncontrolled CINV. A pharmacist-run tele-oncology service for real-time monitoring of CINV is feasible in ambulatory cancer patients. Incorporating the monitoring of other side effects will enhance its value and acceptance by patients for post-chemotherapy symptom management.

Eye-tracking computer systems for inpatients with tetraplegia: findings from a feasibility study.

PubMed

van Middendorp, J J; Watkins, F; Park, C; Landymore, H

2014-12-02

Study design:A longitudinal, prospective, self-controlled cohort study.Objectives:To determine (1) the preliminary benefits of using eye-tracking computer systems (ETCSs) among inpatients with tetraplegia and (2) the feasibility of carrying out a well-powered randomized controlled trial.Setting:Specialist Spinal Cord Injuries Centre, United Kingdom; 6 months during 2013-2014.Methods:Individuals with tetraplegia who were admitted to the center and enrolled in this study were trained and allowed to use the ETCS (Tobii Eyegaze C15 System) twice a week for a duration of 10 weeks. Standardized training modules were developed and offered to all study participants. Study feasibility indicators as well as the Appraisals of Disability: Primary and Secondary Scale, Hospital Anxiety and Depression Scale and the Assistive Technology Device Predisposition Assessment questionnaire scores were taken before and after study enrollment.Results:A total of 31 inpatients with tetraplegia were screened. Although 14 patients (45%) met the study eligibility criteria, 6 patients (19%) consented to be enrolled in the study. Three participants did not complete the planned training schedule because of medical, technical and logistic reasons. Although half of the participants agreed that the ETCS under study was easy to use, no substantial improvements were seen in terms of psychological outcomes, appraisals of disability or independence.Conclusions:The conduct of a controlled trial evaluating the benefits of using ETCSs among newly injured patients with tetraplegia comes with considerable feasibility challenges. Until substantial technical improvements of ETCSs have been implemented, future research should initially focus on those individuals with tetraplegia who are living in the community and who have expressed a need to enhance their computer access and communication skills.Spinal Cord advance online publication, 2 December 2014; doi:10.1038/sc.2014.219.

Prospective Nonrandomized Comparative Study of Laparoscopic Versus Open Surgical Staging for Endometrial Cancer in India.

PubMed

Ansar P P; Ayyappan S; Mahajan, Vikash

2018-06-01

Laparoscopic procedures to treat endometrial cancer are currently emerging. At present, we have evidence to do laparoscopic oncologic resections for endometrial cancer as proven by many prospective studies from abroad such as LAP2 by GOG. So, we have decided to assess the safety and feasibility of such a study in our population with the following as our primary objectives: (1) to study whether laparoscopy is better compared to open approach in terms of duration of hospital stay, perioperative morbidity and early recovery from surgical trauma and (2) to study whether the laparoscopic approach is noninferior to the open approach in terms of number of lymph nodes harvested in lymphadenectomy and rate of conversion to open surgery. We did a prospective nonrandomized comparative study of open versus laparoscopy approach for surgical staging of endometrial cancer from 16th May 2013 to 15th May 2015. To prove a significant difference in the hospital stay, we needed 29 patients in each arm. Thirty patients in each arm were enrolled for the study. The median duration of stay in the open arm was 7 days and in the laparoscopy arm it was 5 days. The advantage of 2 days in the laparoscopic arm was statistically significant ( P value 0.006). Forty percent of patients in the open arm had to stay in the hospital for more than 7 days whereas only 3% of patients in the laparoscopy arm required to stay for more than 7 days ( P value 0.001). This difference was statistically significant. There was no significant difference between the early complication rates between the two arms (20% in open vs. 13% in laparoscopy; P value 0.730). There was a conversion rate of 10% in laparoscopy. The median number of nodes harvested in open arm was 16.50 and in the laparoscopy arm, it was 13.50. The difference was not statistically significant ( P value 0.086). Laparoscopy approach for endometrial cancer staging is feasible in Indian patients and the short-term advantages are replicable with same oncologic safety as proved by randomized controlled trials.

Can body composition be used to optimize the dose of platinum chemotherapy in lung cancer? A feasibility study.

PubMed

Crosby, Vincent; D'Souza, Catherine; Bristow, Carina; Proffitt, Amy; Hussain, Asmah; Potter, Vanessa; Hennig, Ivo; O'Connor, Richard; Baracos, Vickie; Wilcock, Andrew

2017-04-01

Current methods of dosing platinum-based chemotherapy are suboptimal. Potentially, taking lean body mass into account may help. To inform the design of a future study, we first examined the feasibility and acceptability of such an approach using dual-energy X-ray absorptiometry (DEXA) and explored aspects suggestive of over- and under-dosing. Patients with lung cancer offered platinum-based chemotherapy over 1 year were identified and, if eligible, invited to take part in a prospective feasibility study. Questionnaires examined acceptability of the DEXA scan and of a future study that randomized between traditional dosing and one adjusted according to body composition. Dose-limiting toxicity (DLT) and a lack of neutropenia explored potential over- and under-dosing, respectively. Of the 173 patients offered chemotherapy, 123 (71%) were ineligible, mostly because of failing entry criteria (84, 49%). Of the 50 approached, 18 (36%) participated, most receiving carboplatin, with 17 providing data. All found a DEXA scan acceptable; other assessments were fully completed, except nadir and pre-chemotherapy blood counts. Most (94%) were prepared to take part in a future study, although the additional hospital visits for a nadir blood count were unpopular with some. Five (29%) patients experienced six episodes of DLT which resulted in discontinuation (3), dose reduction (2) or change to a less toxic regimen (1). Nine (60%) patients experienced either no (2) or inconsistent (7) neutropenia. A randomized trial appears acceptable and feasible in patients receiving carboplatin. Adjustment of our entry criteria and avoiding a hospital visit for a nadir blood count should aid recruitment.

Feasibility of Energy Medicine in a Community Teaching Hospital: An Exploratory Case Series

PubMed Central

Dufresne, Francois; Simmons, Bonnie; Vlachostergios, Panagiotis J.; Fleischner, Zachary; Joudeh, Ramsey; Blakeway, Jill

2015-01-01

Abstract Background: Energy medicine (EM) derives from the theory that a subtle biologic energy can be influenced for therapeutic effect. EM practitioners may be trained within a specific tradition or work solo. Few studies have investigated the feasibility of solo-practitioner EM in hospitals. Objective: This study investigated the feasibility of EM as provided by a solo practitioner in inpatient and emergent settings. Design: Feasibility study, including a prospective case series. Settings: Inpatient units and emergency department. Outcome measures: To investigate the feasibility of EM, acceptability, demand, implementation, and practicality were assessed. Short-term clinical changes were documented by treating physicians. Participants: Patients, employees, and family members were enrolled in the study only if study physicians expected no or slow improvement in specific symptoms. Those with secondary gains or who could not communicate perception of symptom change were excluded. Results: EM was found to have acceptability and demand, and implementation was smooth because study procedures dovetailed with conventional clinical practice. Practicality was acceptable within the study but was low upon further application of EM because of cost of program administration. Twenty-four of 32 patients requested relief from pain. Of 50 reports of pain, 5 (10%) showed no improvement; 4 (8%), slight improvement; 3 (6%), moderate improvement; and 38 (76%), marked improvement. Twenty-one patients had issues other than pain. Of 29 non–pain-related problems, 3 (10%) showed no, 2 (7%) showed slight, 1 (4%) showed moderate, and 23 (79%) showed marked improvement. Changes during EM sessions were usually immediate. Conclusions: This study successfully implemented EM provided by a solo practitioner in inpatient and emergent hospital settings and found that acceptability and demand justified its presence. Most patients experienced marked, immediate improvement of symptoms associated with their chief complaint. Substantial practicality issues must be addressed to implement EM clinically in a hospital, however. PMID:26035025

Handheld calorimeter is a valid instrument to quantify resting energy expenditure in hospitalized cirrhotic patients: a prospective study.

PubMed

Glass, Cathy; Hipskind, Peggy; Cole, Denise; Lopez, Rocio; Dasarathy, Srinivasan

2012-10-01

Nutrition management of cirrhosis in hospitalized patients is overlooked despite the clinical significance of sarcopenia or loss of muscle mass in cirrhosis. Determining optimal nutrition requirement needs precise measurement of resting energy expenditure (REE) in the cirrhotic patient. Predictive equations are not accurate, and the metabolic cart is expensive and cumbersome. The authors therefore performed a prospective study to examine the feasibility and accuracy of a handheld respiratory calorimeter (HHRC) in quantifying the REE in hospitalized cirrhotic patients not in the intensive care unit. The study was done in 2 phases: in the first phase, the REE of 24 consecutive healthy volunteers was measured using an HHRC in different positions. The objective of this phase was to identify the impact of body and arm position on measured REE. Subsequently, in the second phase of the study, REE was measured using the HHRC and the metabolic cart in 25 consecutive well-characterized, hospitalized cirrhotic patients. The degree of concordance was calculated. Body position and arm position did not significantly affect the measured REE using HHRC. In patients with cirrhosis, the mean measured REE (kcal/d) using the HHRC was 1453.2 ± 319.3 in the hospital room, 1525.6 ± 305.2 in a quiet environment, and 1553.7 ± 270.6 with the metabolic cart (P > .1). Predicted REE using 2 widely used equations did not correlate either with each other or with the measured REE. HHRC is a valid, feasible, and rapid method to determine optimal caloric needs in hospitalized cirrhotic patients.

20 CFR 641.525 - Are there any other groups of individuals who should be given special consideration when...

Code of Federal Regulations, 2010 CFR

2010-04-01

..., to the extent feasible, to individuals who have incomes below the poverty level, who have poor employment prospects and who have the greatest social and/or economic need and to individuals who are...

Grey situation group decision-making method based on prospect theory.

PubMed

Zhang, Na; Fang, Zhigeng; Liu, Xiaqing

2014-01-01

This paper puts forward a grey situation group decision-making method on the basis of prospect theory, in view of the grey situation group decision-making problems that decisions are often made by multiple decision experts and those experts have risk preferences. The method takes the positive and negative ideal situation distance as reference points, defines positive and negative prospect value function, and introduces decision experts' risk preference into grey situation decision-making to make the final decision be more in line with decision experts' psychological behavior. Based on TOPSIS method, this paper determines the weight of each decision expert, sets up comprehensive prospect value matrix for decision experts' evaluation, and finally determines the optimal situation. At last, this paper verifies the effectiveness and feasibility of the method by means of a specific example.

Grey Situation Group Decision-Making Method Based on Prospect Theory

PubMed Central

Zhang, Na; Fang, Zhigeng; Liu, Xiaqing

2014-01-01

This paper puts forward a grey situation group decision-making method on the basis of prospect theory, in view of the grey situation group decision-making problems that decisions are often made by multiple decision experts and those experts have risk preferences. The method takes the positive and negative ideal situation distance as reference points, defines positive and negative prospect value function, and introduces decision experts' risk preference into grey situation decision-making to make the final decision be more in line with decision experts' psychological behavior. Based on TOPSIS method, this paper determines the weight of each decision expert, sets up comprehensive prospect value matrix for decision experts' evaluation, and finally determines the optimal situation. At last, this paper verifies the effectiveness and feasibility of the method by means of a specific example. PMID:25197706

Fast track multi-discipline treatment (FTMDT trial) versus conventional treatment in colorectal cancer--the design of a prospective randomized controlled study

PubMed Central

2011-01-01

Background Laparoscopy-assisted surgery, fast-track perioperative treatment are both increasingly used in colorectal cancer treatment, for their short-time benefits of enhanced recovery and short hospital stays. However, the benefits of the integration of the Laparoscopy-assisted surgery, fast-track perioperative treatment, and even with the Xelox chemotherapy, are still unknown. In this study, the three treatments integration is defined as "Fast Track Multi-Discipline Treatment Model" for colorectal cancer and this model extends the benefits to the whole treatment process of colorectal cancer. The main purpose of the study is to explore the feasibility of "Fast Track Multi-Discipline Treatment" model in treatment of colorectal cancer. Methods The trial is a prospective randomized controlled study with 2 × 2 balanced factorial design. Patients eligible for the study will be randomized to 4 groups: (I) Laparoscopic surgery with fast track perioperative treatment and Xelox chemotherapy; (II) Open surgery with fast track perioperative treatment and Xelox chemotherapy; (III) Laparoscopic surgery with conventional perioperative treatment and mFolfox6 chemotherapy; (IV) Open surgery with conventional perioperative treatment and mFolfox6 chemotherapy. The primary endpoint of this study is the hospital stays. The secondary endpoints are the quality of life, chemotherapy related adverse events, surgical complications and hospitalization costs. Totally, 340 patients will be enrolled with 85 patients in each group. Conclusions The study initiates a new treatment model "Fast Track Multi-Discipline Treatment" for colorectal cancer, and will provide feasibility evidence on the new model "Fast Track Multi-Discipline Treatment" for patients with colorectal cancer. Trial registration ClinicalTrials.gov: NCT01080547 PMID:22111914

An eHealth Application of Self-Reported Sports-Related Injuries and Illnesses in Paralympic Sport: Pilot Feasibility and Usability Study.

PubMed

Fagher, Kristina; Jacobsson, Jenny; Dahlström, Örjan; Timpka, Toomas; Lexell, Jan

2017-11-29

Sport participation is associated with a risk of sports-related injuries and illnesses, and Paralympic athletes' additional medical issues can be a challenge to health care providers and medical staff. However, few prospective studies have assessed sports-related injuries and illnesses in Paralympic sport (SRIIPS) over time. Advances in mobile phone technology and networking systems offer novel opportunities to develop innovative eHealth applications for collection of athletes' self-reports. Using eHealth applications for collection of self-reported SRIIPS is an unexplored area, and before initiation of full-scale research of SRIIPS, the feasibility and usability of such an approach needs to be ascertained. The aim of this study was to perform a 4-week pilot study and (1) evaluate the monitoring feasibility and system usability of a novel eHealth application for self-reported SRIIPS and (2) report preliminary data on SRIIPS. An eHealth application for routine collection of data from athletes was developed and adapted to Paralympic athletes. A 4-week pilot study was performed where Paralympic athletes (n=28) were asked to weekly self-report sport exposure, training load, general well-being, pain, sleep, anxiety, and possible SRIIPS. The data collection was followed by a poststudy use assessment survey. Quantitative data related to the system use (eg, completed self-reports, missing responses, and errors) were analyzed using descriptive statistics. The qualitative feasibility and usability data provided by the athletes were condensed and categorized using thematic analysis methods. The weekly response rate was 95%. The athletes were of the opinion that the eHealth application was usable and feasible but stated that it was not fully adapted to Paralympic athletes and their impairments. For example, it was difficult to understand how a new injury or illness should be identified when the impairment was involved. More survey items related to the impairments were requested, as the athletes perceived that injuries and illnesses often occurred because of the impairment. Options for description of multifactorial incidents including an injury, an illness, and the impairment were also insufficient. Few technical issues were encountered, but athletes with visual impairment reported usability difficulties with the speech synthesizer. An incidence rate of 1.8 injuries and 1.7 illnesses per 100 hours of athlete exposure were recorded. The weekly pain prevalence was 56% and the impairment contributed to 20% of the reported incidents. The novel eHealth-based application for self-reported SRIIPS developed and tested in this pilot study was generally feasible and usable. With some adaptation to accommodate Paralympic athletes' prerequisites and improved technical support for athletes with visual impairment, this application can be recommended for use in prospective studies of SRIIPS. ClinicalTrials.gov NCT02788500; https://clinicaltrials.gov/ct2/show/NCT02788500 (Archived by WebCite at http://www.webcitation.org/6v56OqTeP). ©Kristina Fagher, Jenny Jacobsson, Örjan Dahlström, Toomas Timpka, Jan Lexell. Originally published in JMIR Human Factors (http://humanfactors.jmir.org), 29.11.2017.

The Use of Intercessory Prayer to Reduce Disruptive Behaviors of Patients With Dementia: A Pilot Feasibility Study.

PubMed

Struve, Ann Riesselman; Lu, Der-Fa; Hart, Laura K; Keller, Theresa

2016-06-01

A prospective longitudinal design was used to identify the feasibility, and preliminary efficacy of 12 weeks of intercessory prayer to reduce the disruptive behaviors of six late-stage dementia patients. One group of Catholic nuns offered the Lord's Prayer for assigned patients twice a day. Intercessory prayer for the entire subject group was also offered, by a second group of nuns, via a Latria (modality) called "Perpetual Adoration." Disruptions were documented from 3 weeks preintervention to 3 weeks postintervention. Consents were received for two thirds of invited patients. Retention was reduced by the death of two patients. Fidelity, assessed by retrospective report, was maintained throughout the study. Use of off-label antipsychotic medications was reduced or discontinued in four patients during the trial. The repeated measures analysis of variance, while indicative of a trend, did not reach a level of significance, likely due to small sample size. However, the average effect on behavior resulted in a reduction of disruptive incidents, for the group, in approximately 27 behavior categories/week. This study suggests that it is feasible to improve the life quality of patients in the terminal phase of their illness through prayer reducing their need to respond to life in a disturbed manner. © The Author(s) 2015.

Feasibility study of utilizing ultraportable projectors for endoscopic video display (with videos).

PubMed

Tang, Shou-Jiang; Fehring, Amanda; Mclemore, Mac; Griswold, Michael; Wang, Wanmei; Paine, Elizabeth R; Wu, Ruonan; To, Filip

2014-10-01

Modern endoscopy requires video display. Recent miniaturized, ultraportable projectors are affordable, durable, and offer quality image display. Explore feasibility of using ultraportable projectors in endoscopy. Prospective bench-top comparison; clinical feasibility study. Masked comparison study of images displayed via 2 Samsung ultraportable light-emitting diode projectors (pocket-sized SP-HO3; pico projector SP-P410M) and 1 Microvision Showwx-II Laser pico projector. BENCH-TOP FEASIBILITY STUDY: Prerecorded endoscopic video was streamed via computer. CLINICAL COMPARISON STUDY: Live high-definition endoscopy video was simultaneously displayed through each processor onto a standard liquid crystal display monitor and projected onto a portable, pull-down projection screen. Endoscopists, endoscopy nurses, and technicians rated video images; ratings were analyzed by linear mixed-effects regression models with random intercepts. All projectors were easy to set up, adjust, focus, and operate, with no real-time lapse for any. Bench-top study outcomes: Samsung pico preferred to Laser pico, overall rating 1.5 units higher (95% confidence interval [CI] = 0.7-2.4), P < .001; Samsung pocket preferred to Laser pico, 3.3 units higher (95% CI = 2.4-4.1), P < .001; Samsung pocket preferred to Samsung pico, 1.7 units higher (95% CI = 0.9-2.5), P < .001. The clinical comparison study confirmed the Samsung pocket projector as best, with a higher overall rating of 2.3 units (95% CI = 1.6-3.0), P < .001, than Samsung pico. Low brightness currently limits pico projector use in clinical endoscopy. The pocket projector, with higher brightness levels (170 lumens), is clinically useful. Continued improvements to ultraportable projectors will supply a needed niche in endoscopy through portability, reduced cost, and equal or better image quality. © The Author(s) 2013.

Feasibility of nonselective testing for hemoglobinopathies in early pregnancy in The Netherlands.

PubMed

Kaufmann, Judith O; Demirel-Güngör, Gönül; Selles, Anke; Hudig, Cisca; Steen, Gerard; Ponjee, Gabrielle; Holleboom, Cas; Freeman, Liv M; Hendiks, Joris; Wijermans, Pierre; Giordano, Piero C; Kerkhoffs, Jean-Louis

2011-12-01

To examine the feasibility of standardized hemoglobinopathy (HBP) carrier testing for pregnant women in The Netherlands in addition to the standard anemia screening. We assessed the prevalence of HBP in women at the time of the first pregnancy visit using both a prospective cohort (N = 703) and a retrospective series of women selected at random (N = 588). For the purpose of analysis, the population was divided into a high risk and a low risk group for HBP based on maternal ethnicity. Screening for HBP utilized standard screening tests for anemia, with additional high performance liquid chromatography (Variant II); molecular analysis was performed by Gap-polymerase chain reaction (Gap-PCR) and if necessary, direct sequencing and multiplex ligation-dependent probe amplification (MLPA). Family history was reported or collected from the medical records. β-Globin defects were found in 3.9% of the total population (50/1291). The frequency in the high risk population was 5.6% (37/656), compared with 1.2% (6/501) in the low risk group. In the prospective study we found 30 HBP carriers, leading to testing of 16 partners and identification of two couples at risk. One affected child was born. Mean gestational age at the screening was 11.3 weeks with a standard deviation (SD) of 5.8. We found that the prevalence of HBP carriers is high enough in our population to warrant HBP testing for the entire multiethnic population in early pregnancy at the time of anemia screening. This is feasible as most women had their booking early in their first trimester. Copyright © 2011 John Wiley & Sons, Ltd.

RNA transcriptional biosignature analysis for identifying febrile infants with serious bacterial infections in the emergency department: a feasibility study.

PubMed

Mahajan, Prashant; Kuppermann, Nathan; Suarez, Nicolas; Mejias, Asuncion; Casper, Charlie; Dean, J Michael; Ramilo, Octavio

2015-01-01

To develop the infrastructure and demonstrate the feasibility of conducting microarray-based RNA transcriptional profile analyses for the diagnosis of serious bacterial infections in febrile infants 60 days and younger in a multicenter pediatric emergency research network. We designed a prospective multicenter cohort study with the aim of enrolling more than 4000 febrile infants 60 days and younger. To ensure success of conducting complex genomic studies in emergency department (ED) settings, we established an infrastructure within the Pediatric Emergency Care Applied Research Network, including 21 sites, to evaluate RNA transcriptional profiles in young febrile infants. We developed a comprehensive manual of operations and trained site investigators to obtain and process blood samples for RNA extraction and genomic analyses. We created standard operating procedures for blood sample collection, processing, storage, shipping, and analyses. We planned to prospectively identify, enroll, and collect 1 mL blood samples for genomic analyses from eligible patients to identify logistical issues with study procedures. Finally, we planned to batch blood samples and determined RNA quantity and quality at the central microarray laboratory and organized data analysis with the Pediatric Emergency Care Applied Research Network data coordinating center. Below we report on establishment of the infrastructure and the feasibility success in the first year based on the enrollment of a limited number of patients. We successfully established the infrastructure at 21 EDs. Over the first 5 months we enrolled 79% (74 of 94) of eligible febrile infants. We were able to obtain and ship 1 mL of blood from 74% (55 of 74) of enrolled participants, with at least 1 sample per participating ED. The 55 samples were shipped and evaluated at the microarray laboratory, and 95% (52 of 55) of blood samples were of adequate quality and contained sufficient RNA for expression analysis. It is possible to create a robust infrastructure to conduct genomic studies in young febrile infants in the context of a multicenter pediatric ED research setting. The sufficient quantity and high quality of RNA obtained suggests that whole blood transcriptional profile analysis for the diagnostic evaluation of young febrile infants can be successfully performed in this setting.

Symplicity multi-electrode radiofrequency renal denervation system feasibility study.

PubMed

Whitbourn, Robert; Harding, Scott A; Walton, Antony

2015-05-01

The aim of this study was to test the safety and performance of the Symplicity™ multi-electrode radio-frequency renal denervation system which was designed to reduce procedure time during renal denervation. The multi-electrode radiofrequency renal denervation system feasibility study is a prospective, non-randomised, open label, feasibility study that enrolled 50 subjects with hypertension. The study utilises a new renal denervation catheter which contains an array of four electrodes mounted in a helical configuration at 90 degrees from each other to deliver radiofrequency energy simultaneously to all four renal artery quadrants for 60 seconds. The protocol specified one renal denervation treatment towards the distal end of each main renal artery with radiofrequency energy delivered for 60 seconds per treatment. Total treatment time for both renal arteries was two minutes. The 12-month change in office systolic blood pressure (SBP) and 24-hour SBP was -19.2±25.2 mmHg, p<0.001, and -7.6±20.0 mmHg, p=0.020, respectively. There were three patients with access-site complications, none of which was related to energy delivery; all were treated successfully. No new renal artery stenosis or hypertensive emergencies occurred. The Symplicity multi-electrode radiofrequency renal denervation system was associated with a significant reduction in SBP at 12 months and minimal complications whilst it also reduced procedure time. NCT01699529.

OS02.1 Multicenter pilot study of radio-chemotherapy as first-line treatment for adults with medulloblastoma - the NOA-07 trial

PubMed Central

Beier, D.; Proescholdt, M.; Reinert, C.; Hattingen, E.; Seidel, C.; Dirven, L.; Lürding, R.; Pfister, S.; Pietsch, T.; Hau, P.

2017-01-01

Abstract Background: Medulloblastoma in adult patients has a low incidence, with 0.6 cases per million. Prognosis depends on clinical factors and medulloblastoma entity. In contrast to children, no prospective data on the feasibility of radio-chemotherapy in adults exists. The German Neuro-Oncology Working Group (NOA) performed a prospective multicenter single-arm Phase II trial to evaluate the feasibility and toxicity of radio-chemotherapy in this population. Methods: The NOA-07 trial combined cranio-spinal irradiation with vincristine, followed by a maximum of eight cycles of cisplatin, lomustine and vincristine. Adverse events, imaging and progression patterns, combined histological and genetic markers, health-related quality of life (HRQoL) and cognition were evaluated prospectively. The primary endpoints were the rate of toxicity-related treatment terminations after four cycles of chemotherapy, and the toxicity profile. Findings: Thirty patients were evaluable. Fifty percent of patients showed classic, and 50% desmoplastic-nodular histology. Sixty-eight percent of patients were genetically classified into the sonic hedgehog (SHH) subgroup without TP53 alterations, 13.6% in wingless (WNT), and 17.7% in Non-WNT/Non-SHH (Group 4). Four cycles of chemotherapy were feasible in the majority of patients (n=21; 70.0%). Leukopenia was the major toxicity, with 79 events of CTC grade 3 and 4 in 17 patients. Polyneuropathy and ototoxicity were the only grade 3 or 4 non-haematological toxicities during the active treatment phase and occurred 12 times in eight patients and one time in one patient, respectively. Events were also calculated per cycle and showed an increase of toxicity over treatment time. Feasibility appeared to be age-dependent, leading to application of four cycles of chemotherapy in 72.7% of patients below age 45 and 62.5% of patients 45 or above. Testing for all eight adjuvant cycles revealed that 45.5% of all patients younger than 45 years completed eight cycles, whereas only 12.5% of patients over 45 years received all cycles. Severe adverse events were significantly more frequent in patients older than 45 years of age (p = 0.040). We observed no treatment-related deaths. During the active treatment period, HRQoL showed clinically relevant improvements in several domains. Verbal fluency also improved. The 3-year EFS rate was 66.6% at the time of databank lock. Interpretation: This is a prospective trial in a homogenous population of adults with medulloblastoma. Radio-chemotherapy was safe and tolerable throughout the active treatment phase and generated improvements of HRQoL and cognition. However, toxicity was more severe than in comparable paediatric trials. Thus, we propose frequent patient surveillance using this regimen. We conclude that NOA-07 sets the standard for future randomized trials in adults with medulloblastoma.

ALternate Site Cardiac ResYNChronization (ALSYNC): a prospective and multicentre study of left ventricular endocardial pacing for cardiac resynchronization therapy.

PubMed

Morgan, John M; Biffi, Mauro; Gellér, László; Leclercq, Christophe; Ruffa, Franco; Tung, Stanley; Defaye, Pascal; Yang, Zhongping; Gerritse, Bart; van Ginneken, Mireille; Yee, Raymond; Jais, Pierre

2016-07-14

The ALternate Site Cardiac ResYNChronization (ALSYNC) study evaluated the feasibility and safety of left ventricular endocardial pacing (LVEP) using a market-released pacing lead implanted via a single pectoral access by a novel atrial transseptal lead delivery system. ALSYNC was a prospective clinical investigation with a minimum of 12-month follow-up in 18 centres of cardiac resynchronization therapy (CRT)-indicated patients, who had failed or were unsuitable for conventional CRT. The ALSYNC system comprises the investigational lead delivery system and LVEP lead. Patients required warfarin therapy post-implant. The primary study objective was safety at 6-month follow-up, which was defined as freedom from complications related to the lead delivery system, implant procedure, or the lead ≥70%. The ALSYNC study enrolled 138 patients. The LVEP lead implant success rate was 89.4%. Freedom from complications meeting the definition of primary endpoint was 82.2% at 6 months (95% CI 75.6-88.8%). In the study, 14 transient ischaemic attacks (9 patients, 6.8%), 5 non-disabling strokes (5 patients, 3.8%), and 23 deaths (17.4%) were observed. No death was from a primary endpoint complication. At 6 months, the New York Heart Association class improved in 59% of patients, and 55% had LV end-systolic volume reduction of 15% or greater. Those patients enrolled after CRT non-response showed similar improvement with LVEP. The ALSYNC study demonstrates clinical feasibility, and provides an early indication of possible benefit and risk of LVEP. NCT01277783. Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2016. For permissions please email: journals.permissions@oup.com.

Safety and feasibility of xenon as an adjuvant to sevoflurane anaesthesia in children undergoing interventional or diagnostic cardiac catheterization: study protocol for a randomised controlled trial.

PubMed

Devroe, Sarah; Lemiere, Jurgen; Van de Velde, Marc; Gewillig, Marc; Boshoff, Derize; Rex, Steffen

2015-03-04

Xenon has minimal haemodynamic side effects when compared to volatile or intravenous anaesthetics. Moreover, in in vitro and in animal experiments, xenon has been demonstrated to convey cardio- and neuroprotective effects. Neuroprotection could be advantageous in paediatric anaesthesia as there is growing concern, based on both laboratory studies and retrospective human clinical studies, that anaesthetics may trigger an injury in the developing brain, resulting in long-lasting neurodevelopmental consequences. Furthermore, xenon-mediated neuroprotection could help to prevent emergence delirium/agitation. Altogether, the beneficial haemodynamic profile combined with its putative organ-protective properties could render xenon an attractive option for anaesthesia of children undergoing cardiac catheterization. In a phase-II, mono-centre, prospective, single-blind, randomised, controlled study, we will test the hypothesis that the administration of 50% xenon as an adjuvant to general anaesthesia with sevoflurane in children undergoing elective cardiac catheterization is safe and feasible. Secondary aims include the evaluation of haemodynamic parameters during and after the procedure, emergence characteristics, and the analysis of peri-operative neuro-cognitive function. A total of 40 children ages 4 to 12 years will be recruited and randomised into two study groups, receiving either a combination of sevoflurane and xenon or sevoflurane alone. Children undergoing diagnostic or interventional cardiac catheterization are a vulnerable patient population, one particularly at risk for intra-procedural haemodynamic instability. Xenon provides remarkable haemodynamic stability and potentially has cardio- and neuroprotective properties. Unfortunately, evidence is scarce on the use of xenon in the paediatric population. Our pilot study will therefore deliver important data required for prospective future clinical trials. EudraCT: 2014-002510-23 (5 September 2014).

Feasibility of 2 × 24-h dietary recalls combined with a food-recording booklet, using EPIC-Soft, among schoolchildren.

PubMed

Trolle, E; Amiano, P; Ege, M; Bower, E; Lioret, S; Brants, H; Kaic-Rak, A; de Boer, E J; Andersen, L F

2011-07-01

The aim of this study was to evaluate the feasibility of the suggested trans-European methodology for undertaking representative dietary surveys among schoolchildren: 2 × 24-h dietary recalls (24-HDRs) combined with a food-recording booklet, using EPIC-Soft (the software developed to conduct 24-HDRs in the European Prospective Investigation into Cancer and Nutrition (EPIC) Study) pc-program. A total of 75 children aged 7-8 years and 70 children aged 12-13 years old were recruited through the Civil Registration System in Denmark, and 57 children aged 7-8 years and 47 children aged 12-13 years were recruited through schools in Spain. Each child with one parent completed two face-to-face 24-HDRs, combined with optional use of a food-recording booklet (FRB) to be filled in by the child, a parent or other proxy persons for preparing the recalls. Feasibility was evaluated by questionnaires completed by parents, children and interviewers, and by selected data from the 24-HDRs. The face-to-face interviews with the child and a parent together are confirmed as feasible. The children participated actively in the interviews, the oldest children being most active. The children, parents and interviewers agreed that children needed help from the parents, and that parents were of help to the child. In both countries, other proxy persons, such as teachers or the school cafeteria staff, were involved before the interview, and the majority of the parents and children reported that the FRB had been a help for the child during the interview. Further results point at specific needed improvements of the tools. The evaluated method is shown feasible in two culturally diverse European populations. However, the feasibility study also points to specific improvements of tools and data collection protocol that are strongly recommended before implementation of the method in each country of a pan-European dietary survey.

Prospects for colliders and collider physics to the 1 PeV energy scale

NASA Astrophysics Data System (ADS)

King, Bruce J.

2000-08-01

A review is given of the prospects for future colliders and collider physics at the energy frontier. A proof-of-plausibility scenario is presented for maximizing our progress in elementary particle physics by extending the energy reach of hadron and lepton colliders as quickly and economically as might be technically and financially feasible. The scenario comprises 5 colliders beyond the LHC—one each of e+e- and hadron colliders and three μ+μ- colliders — and is able to hold to the historical rate of progress in the log-energy reach of hadron and lepton colliders, reaching the 1 PeV constituent mass scale by the early 2040's. The technical and fiscal requirements for the feasibility of the scenario are assessed and relevant long-term R&D projects are identified. Considerations of both cost and logistics seem to strongly favor housing most or all of the colliders in the scenario in a new world high energy physics laboratory.

The feasibility and perioperative complications of outpatient knee arthroplasty.

PubMed

Berger, Richard A; Kusuma, Sharat K; Sanders, Sheila A; Thill, Elizabeth S; Sporer, Scott M

2009-06-01

The duration of hospitalization and subsequent length of recovery after elective knee arthroplasty have decreased. We hypothesized same-day discharge following either a unicompartmental (UKA) or total knee arthroplasty (TKA) in an unselected group of patients would not result in a higher perioperative complication rate than standard-length hospitalization when following a comprehensive perioperative clinical pathway, including preoperative teaching, regional anesthesia, preemptive oral analgesia, preemptive antiemetics, and a rapid rehabilitation protocol. We prospectively followed 111 of all 121 patients who had primary knee arthroplasty completed by noon and who agreed to be followed prospectively; 25 had UKA and 86 TKA. Of the 111 patients, 104 (94%, 24 with UKA and 80 with TKA) met discharge criteria and were discharged directly to home the day of surgery. Nausea requiring additional treatment before discharge was the most common reason for a delay in discharge. There were four (3.6%) readmissions (all with TKA) and one emergency room visit without readmission (in a patient with a TKA) within the first week after surgery, while there were four subsequent readmissions (3.6%) and one additional emergency room visit without readmission within three months of surgery, all among patients undergoing TKA. There were no deaths, cardiac events, or pulmonary complications during this study. Outpatient knee arthroplasty surgery is feasible in a large percentage of patients yet early readmissions may be decreased with a prolonged hospitalization. Level IV, therapeutic study. See Guidelines for Authors for a complete description of levels of evidence.

Prospective Study of Combined Colon and Endometrial Cancer Screening in Women With Lynch Syndrome: A Patient-Centered Approach

PubMed Central

Huang, Marilyn; Sun, Charlotte; Boyd-Rogers, Stephanie; Burzawa, Jennifer; Milbourne, Andrea; Keeler, Elizabeth; Yzquierdo, Rebecca; Lynch, Patrick; Peterson, Susan K.; Lu, Karen

2011-01-01

Background: Endometrial and colorectal cancers are the most common cancers in Lynch syndrome. Consensus guidelines recommend annual endometrial biopsy (EMB) and regular colonoscopies. We assessed the feasibility of concurrently performing EMB and colonoscopy and evaluated women's perception of pain, satisfaction, and acceptability. Methods: From July 2002 to December 2009, women who had a gene mutation for Lynch syndrome, met the Amsterdam II criteria, or had a high-risk situation that required screening were prospectively enrolled. After conscious sedation, the procedures were sequentially performed. Patients completed pre- and postprocedure questionnaires assessing pain, level of satisfaction, and acceptability. The Wilcoxon rank test and Mann-Whitney test were used to compare pain scores. Results: Forty-two women completed the study. Median age was 37 years (range, 25 to 73). Nineteen had previously had an EMB in the office setting. Women reported significantly lower median levels of pain in the combined procedure compared with previous office setting biopsies (P < .001). Regardless of parity, women reported significantly less pain for an EMB as part of the combined screen compared with an office EMB (parous, P = .003; nulliparous, P = .026). Women also reported a high level of satisfaction and more convenience in the combined procedure. All participants preferred combined to separately scheduled procedures and would recommend the combined procedure to their relatives. Conclusion: Combined colon and endometrial cancer screening is a patient-centered approach that is feasible, acceptable, and may improve adherence to Lynch syndrome screening recommendations. PMID:21532810

Transoral robotic surgery using the thulium:YAG laser: a prospective study.

PubMed

Van Abel, Kathryn M; Moore, Eric J; Carlson, Matthew L; Davidson, Jennifer A; Garcia, Joaquin J; Olsen, Steven M; Olsen, Kerry D

2012-02-01

To compare thulium:YAG laser-assisted transoral robotic surgery (TY:TORS) and conventional electrocautery-equipped TORS (EC:TORS) in patients undergoing transoral resection of upper aerodigestive tract malignant neoplasms. Prospective matched cohort study. Tertiary academic referral center. Fifteen patients undergoing TY:TORS were matched on the basis of tumor site, clinical T stage, sex, and age with 30 control subjects undergoing EC:TORS. The primary outcome was a comparison between the feasibility of TY:TORS compared with EC:TORS. The secondary outcome was a comparison between the safety and functional outcome of TY:TORS compared with EC:TORS in patients undergoing resection of upper aerodigestive tract malignant neoplasms. All the tumors underwent complete excision with negative margins. Estimated blood loss was minimal (<150 mL) for 87% of TY:TORS patients (13 of 15) and 63% of EC:TORS controls (19 or 30). Intraoperative pharyngotomy was reported in 8% of TY:TORS patients (1 of 13) and 42% of EC:TORS controls (11 of 30) (P = .03). Postoperative pain was greater in EC:TORS compared with TY:TORS (P = .02). No statistically significant differences were noted in hemostasis, postoperative bleeding rates, or other complications. Compared with EC:TORS, TY:TORS seems feasible and safe. In addition, TY:TORS resulted in fewer intraoperative pharyngotomies and less postoperative pain than did EC:TORS, which may be because of decreased collateral thermal damage, improved visualization, and finer cutting using the thulium laser.

Definitional-mission report: I-shaped power-interconnection study in Thailand. Export trade information

DOE Office of Scientific and Technical Information (OSTI.GOV)

Shrivastava, V.K.; Sandell, D.H.

The Government of Thailand is implementing a Southern Seaboard Development Project. The developing of the project will increase demand for all utility and infrastructure systems and services. The distribution of electric power in the new area falls within the responsibility of the Provincial Electricity Authority (PEA). The U.S. Trade and Development Program (TDP) funded a Definitional Mission to evaluate the prospects of TDP funding a feasibility study for an I-Shaped power interconnection study for supplying electricity to the 15 provinces in Southern Thailand. The mission concluded that TDP should provide a grant to PEA to select a U.S. firm tomore » carry out the proposed I-Shaped Interconnection study for power distribution in southern Thailand. The overall potential for exports resulting from the project is conservatively estimated at $120 million, not including any follow-on work and spare parts inventory, typical of such projects. TDP's program in Thailand has enjoyed enviable success in exports and TDP's support of the proposed feasibility study will clearly maintain and very likely add to that momentum.« less

Evaluation of a mobile voiding diary for pediatric patients with voiding dysfunction: a prospective comparative study.

PubMed

Johnson, Emilie K; Estrada, Carlos R; Johnson, Kathryn L; Nguyen, Hiep T; Rosoklija, Ilina; Nelson, Caleb P

2014-09-01

One potential strategy for improving voiding diary completion rates and data quality is use of a mobile electronic format. We evaluated the acceptability and feasibility of mobile voiding diaries for patients with nonneurogenic lower urinary tract dysfunction, and compared mobile and paper voiding diaries. We prospectively enrolled children presenting with daytime symptoms of lower urinary tract dysfunction between July 2012 and April 2013. We enrolled an initial cohort of patients who were provided a paper voiding diary and a subsequent cohort who were provided a mobile voiding diary. We conducted in person interviews and assessed completion rates and quality, comparing paper and mobile voiding diary groups. We enrolled 45 patients who received a paper voiding diary and 38 who received a mobile voiding diary. Completion rates were 78% for paper voiding diaries and 61% for mobile voiding diaries (p = 0.10). Data quality measures for patients completing paper vs mobile voiding diaries revealed a larger proportion (63% vs 52%) providing a full 5 days of data and a smaller proportion (20% vs 65%) with data gaps. However, the paper voiding diary also demonstrated a lower proportion (80% vs 100%) that was completely legible and a lower proportion (40% vs 65%) with completely prospective data entry. The use of a mobile voiding diary was acceptable and feasible for our patients with lower urinary tract dysfunction, although completion rates were somewhat lower compared to paper voiding diaries. Data quality was not clearly better for either version. The mobile voiding diary format may offer data quality advantages for select groups but it did not display significant superiority when provided universally. Copyright © 2014 American Urological Association Education and Research, Inc. Published by Elsevier Inc. All rights reserved.

Prospective evaluation of tools to assess the psychological response of CPR provision to a relative who has suffered a cardiac arrest: a pilot project.

PubMed

Nunnink, Leo; Williamson, Fran; Broome, Annette; McNeill, Iain

2011-02-01

We aimed to evaluate assessment tools to measure the psychological impact of providing CPR to a relative. We set out to evaluate the Revised Impact of Event Scale (IES-R) and Texas Inventory of Grief (TIG) for comparing CPR providers and non-providers, and to establish whether research of this nature had a negative impact on the participants. We also collected narrative data from CPR providers. Prospective sampling of relatives of patients presenting to hospital who had witnessed their relative have a cardiac arrest and who had performed or witnessed CPR. Participants performed two interviews and completed the IES-R and the TIG. Twenty-nine cardiac arrest victims presented, with ten relatives enrolled. The IES-R and TIG were feasible, and registered moderate responses from CPR providers and non-providers. There was no significant difference in the IES-R score between CPR providers and non-providers (1.96 vs. 1.04, p=0.3). There was no significant difference between scores obtained at two different time points (1.75 vs. 1.63, p=0.43). Participants demonstrated a moderate response on the TIG (mean TIG score 2.8, SD 1.7). Participants did not have a negative perception of study involvement, and actually perceived a benefit from discussion with a health professional. It is acceptable and achievable to prospectively assess the response of a cardiac arrest victim's relatives to the provision of CPR. The test instruments used were appropriate and feasible. Results suggested a sample size of 48 to achieve a statistically significant result. Crown Copyright © 2010. Published by Elsevier Ireland Ltd. All rights reserved.

Locoregional mitomycin C injection for esophageal stricture after endoscopic submucosal dissection.

PubMed

Machida, H; Tominaga, K; Minamino, H; Sugimori, S; Okazaki, H; Yamagami, H; Tanigawa, T; Watanabe, K; Watanabe, T; Fujiwara, Y; Arakawa, T

2012-06-01

This prospective study aimed to evaluate the feasibility and safety of locoregional mitomycin C (MMC) injection to treat refractory esophageal strictures after endoscopic submucosal dissection (ESD) for superficial esophageal carcinoma. Patients with dysphagia and strictures that were refractory to repeated endoscopic balloon dilation (EBD) were eligible. After EBD, MMC was injected into the dilated site. Between June 2009 and August 2010, five patients were recruited. The treatment was performed once in two patients and twice in three patients with recurrent dysphagia or restenosis. In all patients, passing a standard endoscope through the site was easy and the dysphagia grade improved (grade 3→1 in 3 patients, grade 4→2 in 2 patients). No serious complications were noted. During the observation period of 4.8 months, neither recurrent dysphagia nor re-stricture appeared in any of the patients. The combination of locoregional MMC injections and EBD is feasible and safe for the treatment of esophageal strictures after ESD.Recently, endoscopic submucosal dissection (ESD) has been developed and accepted as a new endoscopic treatment for gastrointestinal tumors. ESD is a promising treatment for superficial esophageal carcinoma (SEC), and it has a reliable en bloc resection rate. However, the application of ESD for widespread lesions is challenging because of the high risk of the development of severe strictures, which lead to a low quality of life after ESD. Although endoscopic balloon dilation (EBD) is effective for benign strictures, it needs to be performed frequently until the dysphagia disappears 1. Mitomycin C (MMC), which is a chemotherapeutic agent derived from some Streptomyces species 2, reduces scar formation when topically applied to a surgical lesion. MMC has been applied to treat strictures in a variety of anatomical locations, including a variety of organs 3. The aim of this study was to prospectively evaluate both the feasibility and the safety of locoregional MMC injection therapy in patients with refractory esophageal strictures after ESD for SEC. © Georg Thieme Verlag KG Stuttgart · New York.

Prospective evaluation of the feasibility, safety, and efficacy of Cocoon Duct Occluder for transcatheter closure of large patent ductus arteriosus: A single-center study with short- and medium-term follow-up results

PubMed Central

Sinha, Santosh Kumar; Razi, Mahmadula; Pandey, Rama Niwas; Kumar, Prakash; Krishna, Vinay; Jha, Mukesh Jitendra; Mishra, Vikas; Asif, Mohammad; Abdali, Nasar; Tewari, Pradyot; Thakur, Ramesh; Pandey, Umeshwar; Varma, Chandra Mohan

2017-01-01

Objective: To evaluate the feasibility, safety, and efficacy of a novel Cocoon Duct Occluder device for the transcatheter closure (TCC) of large patent ductus arteriosus (PDA). Methods: In this prospective, non-randomized study, consecutive patients with large PDA (narrowest diameter: ≥3.5/4.0 mm in symptomatic/asymptomatic patients, respectively), who underwent TCC with Cocoon Duct Occluder at our institute between November, 2012 and June, 2016 were examined. TCC was performed using the standard technique, and devices were antegradely delivered via 6–10F delivery sheaths. Device embolization, residual shunt, hemolysis, left pulmonary artery (LPA) stenosis, procedural and fluoroscopy time, and mortality were assessed. Patients were followed-up by transthoracic echocardiography with color Doppler imaging at 24 h (D1), 1 month (D30), and 6 months (D180) after implantation. Results: A total of 57 patients (age: 11.7±2.8 years; weight: 22.3±3.5 kg) were enrolled. The mean narrowest diameter was 7.4±0.7 mm. The PDA closure was successfully performed in each patient. Fluoroscopy and procedural time was 6.7±3.2 min and 23.9±2.7 min, respectively. Postprocedural angiography revealed that 49 (85.9%) patients had immediate and complete closure, whereas 8 (14.1%) had residual shunt. Color Doppler imaging at D1 revealed complete closure in 52 (91.3%) patients. At D30, complete closure was reported in all patients and was maintained at D180. Hemolysis, embolization, obstruction of LPA or descending aorta, and death were not reported till D180. Conclusion: TCC using Cocoon Duct Occluder is feasible, safe, and effective in the management of patients with large PDA, with excellent results on short- and medium-term follow-up. PMID:29145233

Probing dark matter at the LHC using vector boson fusion processes.

PubMed

Delannoy, Andres G; Dutta, Bhaskar; Gurrola, Alfredo; Johns, Will; Kamon, Teruki; Luiggi, Eduardo; Melo, Andrew; Sheldon, Paul; Sinha, Kuver; Wang, Kechen; Wu, Sean

2013-08-09

Vector boson fusion processes at the Large Hadron Collider (LHC) provide a unique opportunity to search for new physics with electroweak couplings. A feasibility study for the search of supersymmetric dark matter in the final state of two vector boson fusion jets and large missing transverse energy is presented at 14 TeV. Prospects for determining the dark matter relic density are studied for the cases of wino and bino-Higgsino dark matter. The LHC could probe wino dark matter with mass up to approximately 600 GeV with a luminosity of 1000  fb(-1).

Feasibility and limits of inguinal hernia repair under local anaesthesia in a limited resource environment: a prospective controlled study.

PubMed

Bourgouin, S; Goudard, Y; Montcriol, A; Bordes, J; Nau, A; Balandraud, P

2017-10-01

Local anaesthesia (LA) has proven effective for inguinal hernia repair in developed countries. Hernias in low to middle income countries represent a different issue. The aim of this study was to analyse the feasibility of LA for African hernia repairs in a limited resource environment. Data from patients who underwent herniorrhaphy under LA or spinal anaesthesia (SA) by the 6th and 7th Forward Surgical Team were prospectively collected. All of the patients benefited from a transversus abdominis plane (TAP) block for postoperative analgesia. Primary endpoints concerned the pain response and conversion to general anaesthesia. Secondary endpoints concerned the complication and recurrence rates. Predictors of LA failure were then identified. In all, 189 inguinal hernias were operated during the study period, and 119 patients fulfilled the inclusion criteria: 57 LA and 62 SA. Forty-eight percent of patients presented with inguinoscrotal hernias. Local anaesthesia led to more pain during surgery and necessitated more administration of analgesics but resulted in fewer micturition difficulties and better postoperative pain control. Conversion rates were not different. Inguinoscrotal hernia and a time interval <50 min between the TAP block and skin incision were predictors of LA failure. Forty-four patients were followed-up at one month. No recurrence was noted. Local anaesthesia is a safe alternative to SA. Small or medium hernias can easily be performed under LA in rural centres, but inguinoscrotal hernias required an ultrasound-guided TAP block performed 50 min before surgery to achieve optimal analgesia, and should be managed only in centres equipped with ultrasonography.

Feasibility and acceptability of a self-measurement using a portable bioelectrical impedance analysis, by the patient with chronic heart failure, in acute decompensated heart failure.

PubMed

Huguel, Benjamin; Vaugrenard, Thibaud; Saby, Ludivine; Benhamou, Lionel; Arméro, Sébastien; Camilleri, Élise; Langar, Aida; Alitta, Quentin; Grino, Michel; Retornaz, Frédérique

2018-06-01

Chronic heart failure (CHF) is a major public health matter. Mainly affecting the elderly, it is responsible for a high rate of hospitalization due to the frequency of acute heart failure (ADHF). This represents a disabling pathology for the patient and very costly for the health care system. Our study is designed to assess a connected and portable bioelectrical impedance analysis (BIA) that could reduce these hospitalizations by preventing early ADHF. This prospective study included patients hospitalized in cardiology for ADHF. Patients achieved 3 self-measurements using the BIA during their hospitalization and answered a questionnaire evaluating the acceptability of this self-measurement. The results of these measures were compared with the clinical, biological and echocardiographic criteria of patients at the same time. Twenty-three patients were included, the self-measurement during the overall duration of the hospitalization was conducted autonomously by more than 80% of the patients. The acceptability (90%) for the use of the portable BIA was excellent. Some correlations were statistically significant, such as the total water difference to the weight difference (p=0.001). There were common trends between the variation of impedance analysis measures and other evaluation criteria. The feasibility and acceptability of a self-measurement of bioelectrical impedance analysis by the patient in AHF opens up major prospects in the management of monitoring patients in CHF. The interest of this tool is the prevention of ADHF leading to hospitalization or re-hospitalizations now requires to be presented by new studies.

Limited-preparation CT colonography in frail elderly patients: a feasibility study.

PubMed

Keeling, Aoife N; Slattery, Michael M; Leong, Sum; McCarthy, Eoghan; Susanto, Maja; Lee, Michael J; Morrin, Martina M

2010-05-01

Full colonic preparation can be onerous and may be poorly tolerated in frail elderly patients. The purpose of this study was to prospectively assess the image quality and diagnostic yield of limited-preparation CT colonography (CTC) in elderly patients with suspected colorectal cancer who were deemed medically unfit or unsuitable for colonoscopy. A prospective study was performed of 67 elderly patients with reduced functional status referred for CTC. Participants were prescribed a limited bowel preparation consisting of a low-residue diet for 3 days, 1 L of 2% oral diatrizoate meglumine (Gastrografin) 24 hours before CTC, and 1 L of 2% oral Gastrografin over the 2 hours immediately before CTC. No cathartic preparation was administered. All colonic segments were graded from 1 to 5 for image quality (1, unreadable; 2, poor; 3, equivocal; 4, good; 5, excellent) and reader confidence. Clinical and conventional colonoscopy follow-up findings were documented, and all colonic and extracolonic pathologic findings were documented. Overall image quality and reader confidence in the evaluation of the colon was rated good or excellent in 84% of the colonic segments. Colonic abnormalities were identified in 12 patients (18%), including four colonic tumors, two polyps, and seven colonic strictures. Incidental extraintestinal findings were detected in 43 patients (64%), including nine patients with lesions radiologically consistent with malignancy. Limited-preparation low-dose CTC is a feasible and useful minimally invasive technique with which to evaluate the colon and exclude gross pathology (mass lesions and polyps > 1 cm) in elderly patients with diminished performance status, yielding good to excellent image quality.

The development of depressive symptoms during medical internship stress predicts worsening vascular function.

PubMed

Fiedorowicz, Jess G; Ellingrod, Vicki L; Kaplan, Mariana J; Sen, Srijan

2015-09-01

We sought to prospectively determine whether the onset of internship stress and any subsequent depression alters physiological markers of early vascular disease We explored potential mechanisms linking stress and depression to vascular disease in a prospective cohort of 37 participants exposed to medical internship stress, an established precipitant of depressive symptomatology. Change in depressive symptom score from baseline over one year of internship stress was inversely correlated with change in the reactive hyperemia index (RHI), a measure of peripheral endothelial function (r=0.41, p=0.01). The change in depressive symptoms in the first six months of internship was similarly related to change in RHI over one year (r=0.38, p=0.02). While the development of depressive symptoms did not significantly impact changes in endothelial progenitor cells (EPCs), EPCs did significantly decrease with the year of internship stress (11.9 to 3.4cells/ml blood; p=0.01). Endothelial function may be a critical link between stress, depression, and cardiovascular disease and a feasible surrogate outcome for prospective studies. Copyright © 2015 Elsevier Inc. All rights reserved.

The Development of Depressive Symptoms During Medical Internship Stress Predicts Worsening Vascular Function

PubMed Central

Fiedorowicz, Jess G.; Ellingrod, Vicki L.; Kaplan, Mariana J.; Sen, Srijan

2015-01-01

Objective We sought to prospectively determine whether the onset of internship stress and any subsequent depression alters physiological markers of early vascular disease Methods We explored potential mechanisms linking stress and depression to vascular disease in a prospective cohort of 37 participants exposed to medical internship stress, an established precipitant of depressive symptomatology. Results Change in depressive symptom score from baseline over one year of internship stress was inversely correlated with change in the reactive hyperemia index (RHI), a measure of peripheral endothelial function (r=0.41, p=0.01). The change in depressive symptoms in the first six months of internship was similarly related to change in RHI over one year (r=0.38, p=0.02). While the development of depressive symptoms did not significantly impact changes in endothelial progenitor cells (EPCs), EPCs did significantly decrease with the year of internship stress (11.9 to 3.4 cells/ml blood; p=0.01). Conclusion Endothelial function may be a critical link between stress, depression, and cardiovascular disease and a feasible surrogate outcome for prospective studies. PMID:26115588

Peroral endoscopic pyloromyotomy is efficacious and safe for refractory gastroparesis: prospective trial with assessment of pyloric function.

PubMed

Jacques, Jérémie; Pagnon, Lauriane; Hure, Florent; Legros, Romain; Crepin, Sabrina; Fauchais, Anne-Laure; Palat, Sylvain; Ducrotté, Philippe; Marin, Benoit; Fontaine, Sebastien; Boubaddi, Nour Edine; Clement, Marie-Pierre; Sautereau, Denis; Loustaud-Ratti, Veronique; Gourcerol, Guillaume; Monteil, Jacques

2018-06-12

 Gastroparesis is a functional disorder with a variety of symptoms that is characterized by delayed gastric emptying in the absence of mechanical obstruction. A recent series of retrospective studies has demonstrated that peroral endoscopic pyloromyotomy (G-POEM) is a promising endoscopic procedure for treating patients with refractory gastroparesis. The aim of this prospective study was to evaluate the feasibility, safety, and efficacy of G-POEM.  20 patients with refractory gastroparesis (10 diabetic and 10 nondiabetic) were prospectively included in the trial. Patients were treated by G-POEM after evaluation of pyloric function using an endoscopic functional luminal imaging probe. Clinical responses were evaluated using the Gastroparesis Cardinal Symptom Index (GCSI), and quality of life was assessed using the Patient Assessment of Upper Gastrointestinal Disorders - Quality of Life scale and the Gastrointestinal Quality of Life Index scores. Gastric emptying was measured using 4-hour scintigraphy before G-POEM and at 3 months.  Feasibility of the procedure was 100 %. Compared with baseline values, G-POEM significantly improved symptoms (GCSI: 1.3 vs. 3.5; P  < 0.001), quality of life, and gastric emptying (T½: 100 vs. 345 minutes, P  < 0.001; %H2: 56.0 % vs. 81.5 %, P  < 0.001; %H4: 15.0 % vs. 57.5 %, P  = 0.003) at 3 months. The clinical success of G-POEM using the functional imaging probe inflated to 50 mL had specificity of 100 % and sensitivity of 72.2 % ( P  = 0.04; 95 % confidence interval 0.51 - 0.94; area under the curve 0.72) at a distensibility threshold of 9.2 mm 2 /mmHg.  G-POEM was efficacious and safe for treating refractory gastroparesis, especially in patients with low pyloric distensibility. © Georg Thieme Verlag KG Stuttgart · New York.

Safety and feasibility of endovascular aortic aneurysm repair as day surgery.

PubMed

Hanley, Stephen C; Steinmetz, Oren; Mathieu, Eva S; Obrand, Daniel; Mackenzie, Kent; Corriveau, Marc-Michel; Abraham, Cherrie Z; Gill, Heather L

2018-06-01

The adoption of endovascular aneurysm repair (EVAR) during the past two decades has led to significantly shorter length of stay as well as lower hospital resource use. Currently, most patients are admitted to the hospital after EVAR; however, there are no standard observation periods, and timing of discharge is based on clinical judgment. The aim of this study was to confirm the safety and feasibility of performing EVAR as outpatient surgery. We developed criteria to identify patients for potential same-day discharge (infrarenal aneurysm, low perioperative risk, to be accompanied for first 24 hours). We then implemented a prospective trial that observed patients planned for same-day discharge and compared them with a historical control group (patients who had undergone EVAR during the previous 2 years and met same-day discharge criteria). Basic demographic and operative data as well as length of stay, inpatient and perioperative complications, emergency department visits, readmissions, reinterventions, and deaths were collected. The primary outcome was the 30-day complication rate, and the study was powered to assess noninferiority. Prospectively, we assessed 266 patients and planned 110 (41%) for outpatient EVAR (62% of historical controls met outpatient criteria). Demographic characteristics were similar between planned outpatients and historical controls. In planned outpatients, hospital stay was significantly shorter (0.7 ± 2.6 days vs 2.5 ± 6.9 days; P < .01), and 79% were discharged the same day of surgery. The 30-day follow-up was available for all study patients and 94% of control patients; there were no differences in complication (11% vs 9%), readmission (2% vs 4%), reintervention (4% vs 4%), or mortality (1% vs 1%) rates, but study patients had significantly more emergency department visits (15% vs 6%; P < .05). Unsuccessful same-day discharge was associated with longer operative times, increased blood loss, and use of general anesthesia. In selected patients undergoing elective EVAR, same-day discharge is feasible without increasing complication rates. Health resource utilization remains a challenge in transitioning to an outpatient model. Copyright © 2018. Published by Elsevier Inc.

A prospective pilot study to evaluate an animated home-based physical exercise program as a treatment option for patients with rheumatoid arthritis.

PubMed

Zernicke, Jan; Kedor, Claudia; Müller, Angela; Burmester, Gerd-Rüdiger; Reißhauer, Anett; Feist, Eugen

2016-08-18

Physical exercises and physiotherapy are of great importance for maintenance of joint function in patients with rheumatoid arthritis (RA). However, many RA patients complain about problems to receive prescriptions or have a lack of access to physiotherapy. Recent reports have shown positive effects of the Wii game console on physical and psychosocial conditions of patients with other underlying diseases. The primary objectives of this prospective controlled pilot study were to investigate feasibility and patients' assessment using an animated home-based exercise program. This pilot study was conducted as a single-center, cross-over trial with two treatment arms over 24 weeks. Eligibility criteria included patients with RA reaching low disease activity under therapy with a biological disease modifying anti-rheumatic drug (bDMARD). After detailed instruction, 15 patients started with a conventional home-based physical exercise program and 15 patients began with a predefined animated exercise program by using the Wii game console for 12 weeks. Afterwards, patients were crossed-over to the other treatment arm for another period of 12 weeks. Multi-methodical assessments were performed by qualitative analysis of the interview-data as well as statistical analysis of functional tests and patient reported outcomes (PRO's). Evaluation of the interviews indicated feasibility and usefulness of the chosen animated home-based exercise program. Forefoot disabilities were identified as a main limiting factor for performing some of the animated exercises. After 12 weeks, both treatment arms showed improvement of functional tests without significant differences between groups: Overall muscle strength improved for a mean value of 10 Newton (+12 %) and the mean 6-min walk test (6-MWT) distance increased for 28 meters (+5 %). This study showed that an animated home-based exercise program by using a Wii game console was feasible and beneficial for RA patients. Compared to standard physical home exercises, similar effects were observed indicating that such an animated program might be an alternative supportive option for RA patients. ClinicalTrials.gov ID: NCT02658370 (19-Jan-2016).

Prescription opioid use and misuse: piloting an educational strategy for rural primary care physicians.

PubMed

Srivastava, Anita; Kahan, Meldon; Jiwa, Ashifa

2012-04-01

To evaluate the feasibility and effectiveness of a multifaceted educational intervention to improve the opioid prescribing practices of rural family physicians in a remote First Nations community. Prospective cohort study. Sioux Lookout, Ont. Family physicians. Eighteen family physicians participated in a 1-year study of a series of educational interventions on safe opioid prescribing. Interventions included a main workshop with a lecture and interactive case discussions, an online chat room, video case conferencing, and consultant support. Responses to questionnaires at baseline and after 1 year on knowledge, attitudes, and practices related to opioid prescribing. The main workshop was feasible and was well received by primary care physicians in remote communities. At 1 year, physicians were less concerned about getting patients addicted to opioids and more comfortable with opioid dosing. Multifaceted education and consultant support might play an important role in improving family physician comfort with opioid prescribing, and could improve the treatment of chronic pain while minimizing the risk of addiction.

A feasibility study comparing UK older adult mental health inpatient wards which use protected engagement time with other wards which do not: study protocol.

PubMed

Nolan, Fiona M; Fox, Chris; Cheston, Richard; Turner, David; Clark, Allan; Dodd, Emily; Khoo, Mary-Ellen; Gray, Richard

2016-01-01

Protected engagement time (PET) is a concept of managing staff time on mental health inpatient wards with the aim of increasing staff and patient interaction. Despite apparent widespread use of PET, there remains a dearth of evidence as to how it is implemented and whether it carries benefits for staff or patients. This protocol describes a study which is being carried out on mental health wards caring for older adults (aged over 65) in England. The study shares a large proportion of the procedures, measures and study team membership of a recently completed investigation of the impact of PET in adult acute mental health wards. The study aims to identify prevalence and components of PET to construct a model for the intervention, in addition to testing the feasibility of the measures and procedures in preparation for a randomised trial. The study comprises four modules and uses a mixed methods approach. Module 1 involves mapping all inpatient wards in England which provide care for older adults, including those with dementia, ascertaining how many of these provide PET and in what way. Module 2 uses a prospective cohort method to compare five older adult mental health wards that use PET with five that do not across three National Health Service (NHS) Foundation Trust sites. The comparison comprises questionnaires, observation tools and routinely collected clinical service data and combines validated measures with questions developed specifically for the study. Module 3 entails an in-depth case study evaluation of three of the participating PET wards (one from each NHS Trust site) using semi-structured interviews with patients, carers and staff. Module 4 describes the development of a model and fidelity scale for PET using the information derived from the other modules with a working group of patients, carers and staff. This is a feasibility study to test the application of the measures and methods in inpatient wards for older adults and develop a draft model for the intervention. The next stage will prospectively involve testing of the model and fidelity scale in randomised conditions to provide evidence for the effectiveness of PET as an intervention. ISRCTN31919196.

Prospective observational studies to assess comparative effectiveness: the ISPOR good research practices task force report.

PubMed

Berger, Marc L; Dreyer, Nancy; Anderson, Fred; Towse, Adrian; Sedrakyan, Art; Normand, Sharon-Lise

2012-01-01

In both the United States and Europe there has been an increased interest in using comparative effectiveness research of interventions to inform health policy decisions. Prospective observational studies will undoubtedly be conducted with increased frequency to assess the comparative effectiveness of different treatments, including as a tool for "coverage with evidence development," "risk-sharing contracting," or key element in a "learning health-care system." The principle alternatives for comparative effectiveness research include retrospective observational studies, prospective observational studies, randomized clinical trials, and naturalistic ("pragmatic") randomized clinical trials. This report details the recommendations of a Good Research Practice Task Force on Prospective Observational Studies for comparative effectiveness research. Key issues discussed include how to decide when to do a prospective observational study in light of its advantages and disadvantages with respect to alternatives, and the report summarizes the challenges and approaches to the appropriate design, analysis, and execution of prospective observational studies to make them most valuable and relevant to health-care decision makers. The task force emphasizes the need for precision and clarity in specifying the key policy questions to be addressed and that studies should be designed with a goal of drawing causal inferences whenever possible. If a study is being performed to support a policy decision, then it should be designed as hypothesis testing-this requires drafting a protocol as if subjects were to be randomized and that investigators clearly state the purpose or main hypotheses, define the treatment groups and outcomes, identify all measured and unmeasured confounders, and specify the primary analyses and required sample size. Separate from analytic and statistical approaches, study design choices may strengthen the ability to address potential biases and confounding in prospective observational studies. The use of inception cohorts, new user designs, multiple comparator groups, matching designs, and assessment of outcomes thought not to be impacted by the therapies being compared are several strategies that should be given strong consideration recognizing that there may be feasibility constraints. The reasoning behind all study design and analytic choices should be transparent and explained in study protocol. Execution of prospective observational studies is as important as their design and analysis in ensuring that results are valuable and relevant, especially capturing the target population of interest, having reasonably complete and nondifferential follow-up. Similar to the concept of the importance of declaring a prespecified hypothesis, we believe that the credibility of many prospective observational studies would be enhanced by their registration on appropriate publicly accessible sites (e.g., clinicaltrials.gov and encepp.eu) in advance of their execution. Copyright © 2012 International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc. All rights reserved.

Participant acceptability of exercise in kidney disease (PACE-KD): a feasibility study protocol in renal transplant recipients

PubMed Central

Bishop, Nicolette C; Billany, Roseanne; Smith, Alice C

2017-01-01

Introduction Cardiovascular disease (CVD) is a major cause of mortality in renal transplant recipients (RTRs). General population risk scores for CVD underestimate the risk in patients with chronic kidney disease (CKD) suggesting additional non-traditional factors. Renal transplant recipients also exhibit elevated inflammation and impaired immune function. Exercise has a positive impact on these factors in patients with CKD but there is a lack of rigorous research in RTRs, particularly surrounding the feasibility and acceptability of high-intensity interval training (HIIT) versus moderate-intensity continuous training (MICT) in this population. This study aims to explore the feasibility of three different supervised aerobic exercise programmes in RTRs to guide the design of future large-scale efficacy studies. Methods and analysis Renal transplant recipients will be randomised to HIIT A (16 min interval training with 4, 2 and 1 min intervals at 80%–90% of peak oxygen uptake (VO2 peak)), HIIT B (4×4 min interval training at 80%–90% VO2peak) or MICT (~40 min cycling at 50%–60% VO2peak) where they will undertake 24 supervised sessions (approximately thrice weekly over 8 weeks). Assessment visits will be at baseline, midtraining, immediate post-training and 3 months post-training. The study will evaluate the feasibility of recruitment, randomisation, retention, assessment procedures and the implementation of the interventions. A further qualitative sub-study QPACE-KD (Qualitative Participant Acceptability of Exercise in Kidney Disease) will explore patient experiences and perspectives through semistructured interviews and focus groups. Ethics and dissemination All required ethical and regulatory approvals have been obtained. Findings will be disseminated through conference presentations, public platforms and academic publications. Trial registration number Prospectively registered; ISRCTN17122775. PMID:28947458

[The Bremen periodic health exam - feasibility of a new concept].

PubMed

Schmiemann, Guido; Biesewig-Siebenmorgen, Jürgen; Gebhardt, Klaus; Egidi, Günther

2014-01-01

All members of the Statutory Health Insurance are entitled to receive preventive health examinations. The current concept, however, does not take individual risk factors into account systematically. To improve this, the "Bremen Health Examination" was developed. The central component is a screening questionnaire to be completed by the patient, which is stratified by age, i.e., 35 to 69 years and ≥ 70 years. The feasibility and acceptance of this concept have been assessed. In a prospective observational study, a selected sample of general practitioners (GPs) was asked to implement the questionnaires during all preventive health examinations within a four-week period. The GPs subsequently answered content-related questions as well as Likert-scaled questions on the relevance of the issues addressed, and the feasibility of the new concept. 17 out of 20 GPs approached for the study included a total of 171 patients. On average, the patients in the two groups were 52 and 75 years of age, respectively, and answered 4.4 prompting questions positively. Age and gender had no significant effect on the frequency of "positively" answered questions. Implementing the questionnaire extended the duration of the health examination, however, GPs overall rated the time required for discussing newly assessed problems as adequate (four-level Likert scale, 1=yes; 4=no; Ø 1.59; SD 0.77). The implementation of the Bremen Health Examination appears to be feasible from the GP perspective. Copyright © 2014. Published by Elsevier GmbH.

Urinalysis of MMX-mesalazine as a tool to monitor 5-ASA adherence in daily IBD practice.

PubMed

Römkens, Tessa E H; Te Morsche, Rene; Peters, Wilbert; Burger, David M; Hoentjen, Frank; Drenth, Joost P H

2018-03-01

Adherence is pivotal but challenging in ulcerative colitis (UC) treatment. Many methods to assess adherence are subjective or have limitations. (Nac-)5-aminosalicylic acid (5-ASA) urinalysis by high-performance liquid chromatography (HPLC) seems feasible and reproducible in healthy volunteers. We performed a prospective study in adult quiescent UC patients to evaluate the feasibility of spot (Nac-)5-ASA urinalysis by HPLC to assess adherence in daily inflammatory bowel disease (IBD) care. Twenty-nine patients (51.7% male, mean age 52 ± 11 years) were included (median FU 9 months) and weekly spot urine samples were collected. We found large variation in spot (Nac-)5-ASA urinary excretion that was unrelated to brand, dosing schedule or dosage of 5-ASA. In conclusion, spot (Nac-)5-ASA urinalysis is not applicable to assess 5-ASA adherence in daily IBD care. © 2017 The British Pharmacological Society.

Plenoptic Ophthalmoscopy: A Novel Imaging Technique.

PubMed

Adam, Murtaza K; Aenchbacher, Weston; Kurzweg, Timothy; Hsu, Jason

2016-11-01

This prospective retinal imaging case series was designed to establish feasibility of plenoptic ophthalmoscopy (PO), a novel mydriatic fundus imaging technique. A custom variable intensity LED array light source adapter was created for the Lytro Gen1 light-field camera (Lytro, Mountain View, CA). Initial PO testing was performed on a model eye and rabbit fundi. PO image acquisition was then performed on dilated human subjects with a variety of retinal pathology and images were subjected to computational enhancement. The Lytro Gen1 light-field camera with custom LED array captured fundus images of eyes with diabetic retinopathy, age-related macular degeneration, retinal detachment, and other diagnoses. Post-acquisition computational processing allowed for refocusing and perspective shifting of retinal PO images, resulting in improved image quality. The application of PO to image the ocular fundus is feasible. Additional studies are needed to determine its potential clinical utility. [Ophthalmic Surg Lasers Imaging Retina. 2016;47:1038-1043.]. Copyright 2016, SLACK Incorporated.

Minimal invasive surgery in the newborn: current status and evidence.

PubMed

Lacher, Martin; Kuebler, Joachim F; Dingemann, Jens; Ure, Benno M

2014-10-01

The evolution of minimally invasive surgery (MIS) in the newborn has been delayed due to the limited working space and the unique physiology. With the development of smaller instruments and advanced surgical skills, many of the initial obstacles have been overcome. MIS is currently used in specialized centers around the world with excellent feasibility. Obvious advantages include better cosmesis, less trauma, and better postoperative musculoskeletal function, in particular after thoracic procedures. However, the aim of academic studies has shifted from proving feasibility to a critical evaluation of outcome. Prospective randomized trials and high-level evidence for the benefit of endoscopic surgery are still scarce. Questions to be answered in the upcoming years will therefore include both advantages and potential disadvantages of MIS, especially in neonates. This review summarizes recent developments of MIS in neonates and the evidence for its use. Copyright © 2014 Elsevier Inc. All rights reserved.

Prospects for a Muon Spin Resonance Facility in the MuCool Test Area

DOE Office of Scientific and Technical Information (OSTI.GOV)

Johnstone, John A.

2017-04-12

This paper investigates the feasibility of re-purposing the MuCool Test Area beamline and experimental hall to support a Muon Spin Resonance facility, which would make it the only such facility in the US. This report reviews the basic muon production concepts studied and operationally implemented at TRIUMF, PSI, and RAL and their application to the MTA facility. Two scenarios were determined feasible. One represents an initial minimal-shielding and capital-cost investment stage with a single secondary muon beamline that transports the primary beam to an existing high-intensity beam absorber located outside of the hall. Another, upgraded stage, involves an optimized productionmore » target pile and high-intensity absorber installed inside the experimental hall and potentially multiple secondary muon lines. In either scenario, with attention to target design, the MTA can host enabling and competitive Muon Spin Resonance experiments« less

Framing 'fracking': Exploring public perceptions of hydraulic fracturing in the United Kingdom.

PubMed

Williams, Laurence; Macnaghten, Phil; Davies, Richard; Curtis, Sarah

2015-07-13

The prospect of fracking in the United Kingdom has been accompanied by significant public unease. We outline how the policy debate is being framed by UK institutional actors, finding evidence of a dominant discourse in which the policy approach is defined through a deficit model of public understanding of science and in which a technical approach to feasibility and safety is deemed as sufficient grounds for good policymaking. Deploying a deliberative focus group methodology with lay publics across different sites in the north of England, we find that these institutional framings are poorly aligned with participants' responses. We find that unease regularly overflows the focus on safety and feasibility and cannot be satisfactorily explained by a lack of understanding on the part of participants. We find that scholarship from science and technology studies productively elucidates our participants' largely sceptical positions, and orientates strategies for responding to them more effectively. © The Author(s) 2015.

Framing ‘fracking’: Exploring public perceptions of hydraulic fracturing in the United Kingdom

PubMed Central

Williams, Laurence; Macnaghten, Phil; Davies, Richard; Curtis, Sarah

2015-01-01

The prospect of fracking in the United Kingdom has been accompanied by significant public unease. We outline how the policy debate is being framed by UK institutional actors, finding evidence of a dominant discourse in which the policy approach is defined through a deficit model of public understanding of science and in which a technical approach to feasibility and safety is deemed as sufficient grounds for good policymaking. Deploying a deliberative focus group methodology with lay publics across different sites in the north of England, we find that these institutional framings are poorly aligned with participants’ responses. We find that unease regularly overflows the focus on safety and feasibility and cannot be satisfactorily explained by a lack of understanding on the part of participants. We find that scholarship from science and technology studies productively elucidates our participants’ largely sceptical positions, and orientates strategies for responding to them more effectively. PMID:26170264

FEASIBILITY AND SAFETY OF CONTRAST-ENHANCED ULTRASOUND IN THE DISTAL LIMB OF SIX HORSES.

PubMed

Seiler, Gabriela S; Campbell, Nigel; Nixon, Britton; Tsuruta, James K; Dayton, Paul A; Jennings, Samuel; Redding, W Rich; Lustgarten, Meghann

2016-05-01

Vascular alterations play important roles in many orthopedic diseases such as osteoarthritis, tendonitis, and synovitis in both human and equine athletes. Understanding these alterations could enhance diagnosis, prognosis, and treatment. Contrast-enhanced ultrasound (CEUS) could be a valuable method for evaluation of blood flow and perfusion of these processes in the equine distal limb, however no reports were found describing feasibility or safety of the technique. The goal of this prospective, experimental study was to describe the feasibility and safety of distal limb CEUS in a sample of six horses. For each horse, CEUS of the distal limb was performed after intravenous injections of 5 and 10 ml, as well as intra-arterial injections of 0.5 and 1 ml contrast medium. Vital parameters were monitored and CEUS images were assessed qualitatively and quantitatively for degree of contrast enhancement. None of the horses had clinically significant changes in their vital parameters after contrast medium injection. One horse had a transient increase in respiratory rate, and several horses had mild increases of systolic blood pressure of short duration after intravenous, but not after intra-arterial injections. Intra-arterial injection was possible in all horses and resulted in significantly improved contrast enhancement both quantitatively (P = 0.027) and qualitatively (P = 0.019). Findings from this study indicated that CEUS is a feasible and safe diagnostic test for evaluation of the equine distal limb. Future studies are needed to assess the clinical utility of this test for horses with musculoskeletal diseases. © 2016 American College of Veterinary Radiology.

Clinical feasibility study of protrach dualcare a new speaking valve with heat and moisture exchanger for tracheotomized patients.

PubMed

de Kleijn, B J; van As-Brooks, C J; Wedman, J; van der Laan, B F A M

2017-12-01

The aim of this study was to evaluate the clinical feasibility of the ProTrach DualCare (Atos Medical, Hörby, Sweden), a device combining a hands-free speaking valve and a Heat and Moisture Exchanger (HME) for tracheotomized patients. A non-randomized, prospective single center feasibility study. Sixteen adult tracheotomized patients were included. Participants were asked to test the DualCare for two weeks while continuing their normal activities. After these two weeks, participants could choose whether or not to take part in the long-term evaluation. The EuroQOL-5D, Borg scale and questionnaires on speaking, pulmonary function and patient preference were used. During the long-term evaluation, a minor redesign was implemented and all participants were asked to test the new device again for one week, with a potential long-term evaluation. Eleven decided to participate. The device was well-tolerated. Speaking noise was reduced ( p  = 0.020) and speech was considered to sound more natural compared to previously used devices according to the users ( p  = 0.020). Overall 11 participants preferred the DualCare to their standard device. No serious adverse events were reported. Overall, 11 of 16 participants preferred the DualCare to their standard speaking valve or HME. Users of the DualCare were able to use hands free speech with the benefits of an HME and the device was considered clinically feasible and has the potential to improve quality of life of tracheotomized patients. 2b.

The feasibility of short term prophylactic antibiotics in gastric cancer surgery.

PubMed

Lee, Jun Suh; Lee, Han Hong; Song, Kyo Young; Park, Cho Hyun; Jeon, Hae Myung

2010-12-01

Most surgeons administer prophylactic antibiotics for 3 to 5 days postoperatively. However, the Center for Disease Control (CDC) guideline recommends antibiotic therapy for 24 hours or less in clean/uncontaminated surgery. Thus, we prospectively studied the use of short term prophylactic antibiotic therapy after gastric cancer surgery. A total of 103 patients who underwent gastric cancer surgery between October 2007 and June 2008 were prospectively enrolled in a short term prophylactic antibiotics program. One gram of cefoxitin was administered 30 minutes before the incision, and one additional gram was administered intraoperatively for cases with an operation time over 3 hours. Postoperatively, one gram was administered 3 times, every 8 hours. Patients were checked routinely for fever. All cases received open surgery, and the surgical wounds were dressed and checked for Surgical Site Infection (SSI) daily. Of the 103 patients, 15 were dropped based on exclusion criteria (severe organ dysfunction, combined resection of the colon, etc). The remaining 88 patients were included in the short-term program of prophylactic antibiotic use. Of these patients, SSIs were detected in 8 (9.1%) and fever after 2 postoperative days was detected in 11 (12.5%). The incidence of SSIs increased with patient age, and postoperative fever correlated with operation time. Short term prophylactic antibiotic usage is feasible in patients who undergo gastric cancer surgery, and where there are no grave comorbidities or combined resection.

The politics of health reform: why do bad things happen to good plans?

PubMed

Oberlander, Jonathan

2003-01-01

This paper examines political feasibility and its implications for health reform. I discuss the political obstacles to health reform in the United States, disentangling perennial barriers from contemporary constraints. I then explore major reform options and their political prospects. I argue that while incremental reform now appears to be the most feasible option, the political climate may change in a way that permits a bolder vision. Moreover, incremental reform may not be sustainable in the long run, for the same reason that makes it politically popular now: It does not change the status quo in the health system.

Neural Activity Reveals Preferences Without Choices

PubMed Central

Smith, Alec; Bernheim, B. Douglas; Camerer, Colin

2014-01-01

We investigate the feasibility of inferring the choices people would make (if given the opportunity) based on their neural responses to the pertinent prospects when they are not engaged in actual decision making. The ability to make such inferences is of potential value when choice data are unavailable, or limited in ways that render standard methods of estimating choice mappings problematic. We formulate prediction models relating choices to “non-choice” neural responses and use them to predict out-of-sample choices for new items and for new groups of individuals. The predictions are sufficiently accurate to establish the feasibility of our approach. PMID:25729468

Some engineering aspects of the Nicholson-Koch mobile chipper

Treesearch

Donald L. Sirois

1981-01-01

A proto-type mobile chip harvester has been designed to harvest forest biomass in the form of logging residuals for use as energy wood. The proto-type is presently undergoing developmental tests. Results are encouraging, indicating mechanical feasibility with prospects of working systems within the next several years.

Motivational engagement in first-time hearing aid users: A feasibility study.

PubMed

Ferguson, Melanie; Maidment, David; Russell, Naomi; Gregory, Melanie; Nicholson, Richard

2016-07-01

To assess (1) the feasibility of incorporating the Ida Institute's Motivation Tools into a UK audiology service, (2) the potential benefits of motivational engagement in first-time hearing aid users, and (3) predictors of hearing aid and general health outcome measures. A feasibility study using a single-centre, prospective, quasi-randomized controlled design with two arms. The Ida Institute's Motivation Tools formed the basis for motivational engagement. First-time hearing aid users were recruited at the initial hearing assessment appointment. The intervention arm underwent motivational engagement (M+, n = 32), and a control arm (M-, n = 36) received standard care only. The M+ group showed greater self-efficacy, reduced anxiety, and greater engagement with the audiologist at assessment and fitting appointments. However, there were no significant between-group differences 10-weeks post-fitting. Hearing-related communication scores predicted anxiety, and social isolation scores predicted depression for the M+ group. Readiness to address hearing difficulties predicted hearing aid outcomes for the M- group. Hearing sensitivity was not a predictor of outcomes. There were some positive results from motivational engagement early in the patient journey. Future research should consider using qualitative methods to explore whether there are longer-term benefits of motivational engagement in hearing aid users.

Feasibility and acceptability of an early childhood obesity prevention intervention: results from the healthy homes, healthy families pilot study.

PubMed

Keita, Akilah Dulin; Risica, Patricia M; Drenner, Kelli L; Adams, Ingrid; Gorham, Gemma; Gans, Kim M

2014-01-01

This study examined the feasibility and acceptability of a home-based early childhood obesity prevention intervention designed to empower low-income racially/ethnically diverse parents to modify their children's health behaviors. We used a prospective design with pre-/posttest evaluation of 50 parent-child pairs (children aged 2 to 5 years) to examine potential changes in dietary, physical activity, and sedentary behaviors among children at baseline and four-month follow-up. 39 (78%) parent-child pairs completed evaluation data at 4-month follow-up. Vegetable intake among children significantly increased at follow-up (0.54 cups at 4 months compared to 0.28 cups at baseline, P = 0.001) and ounces of fruit juice decreased at follow-up (11.9 ounces at 4 months compared to 16.0 ounces at baseline, P = 0.036). Sedentary behaviors also improved. Children significantly decreased time spent watching TV on weekdays (P < 0.01) and also reduced weekend TV time. In addition, the number of homes with TV sets in the child's bedroom also decreased (P < 0.0013). The findings indicate that a home-based early childhood obesity prevention intervention is feasible, acceptable and demonstrates short-term effects on dietary and sedentary behaviors of low-income racially/ethnically diverse children.

The feasibility of single-port laparoscopic appendectomy using a solo approach: a comparative study.

PubMed

Kim, Say-June; Choi, Byung-Jo; Jeong, Wonjun; Lee, Sang Chul

2016-03-01

To investigate the feasibility and safety of solo surgery with single-port laparoscopic appendectomy, which is termed herein solo-SPLA (solo-single-port laparoscopic appendectomy). This study prospectively collected and retrospectively analyzed data from patients who had undergone either non-solo-SPLA (n = 150) or solo-SPLA (n = 150). Several devices were utilized for complete, skin-to-skin solo-SPSA, including a Lone Star Retractor System and an adjustable mechanical camera holder. Operating times were not significantly different between solo- and non-solo-SPLA (45.0 ± 21.0 minutes vs. 46.7 ± 26.1 minutes, P = 0.646). Most postoperative variables were also comparable between groups, including the necessity for intravenous analgesics (0.7 ± 1.2 ampules [solo-SPLA] vs. 0.9 ± 1.5 ampules [non-solo-SPLA], P = 0.092), time interval to gas passing (1.3 ± 1.0 days vs. 1.4 ± 1.0 days, P = 0.182), and the incidence of postoperative complications (4.0% vs. 8.7%, P = 0.153). Moreover, solo-SPLA effectively lowered the operating cost by reducing surgical personnel expenses. Solo-SPLA economized staff numbers and thus lowered hospital costs without lengthening of operating time. Therefore, solo-SPLA could be considered a safe and feasible alternative to non-solo-SPLA.

Transradial access for visceral endovascular interventions in morbidly obese patients: safety and feasibility.

PubMed

Biederman, Derek M; Marinelli, Brett; O'Connor, Paul J; Titano, Joseph J; Patel, Rahul S; Kim, Edward; Tabori, Nora E; Nowakowski, Francis S; Lookstein, Robert A; Fischman, Aaron M

2016-05-07

Transradial access (TRA) has been shown to lower morbidity and bleeding complications compared to transfemoral access in percutaneous coronary interventions. Morbid obesity, commonly defined as a body mass index (BMI) ≥40 kg/m2, has been shown to be a risk factor for access site complications irrespective of access site. This study evaluates the safety and feasibility of performing visceral endovascular interventions in morbidly obese patients via TRA. Procedural details, technical success, and 30-day major and minor access site, bleeding, and neurological adverse events were prospectively recorded in a database of 1057 procedures performed via the radial artery. From this database we identified 22 visceral interventions performed with TRA in 17 morbidly obese patients (age: 53 ± 11 years, female: 71%) with a median BMI of 42.7 kg/m2. Interventions included radio-embolization (n = 7, 31.8%), chemo-embolization (n = 6, 27.3%), uterine fibroid embolization (n = 4, 18.2%), renal embolization (n = 2, 9.1%), hepatic embolization (n = 1, 4.5%), lumbar artery embolization (n = 1, 4.5%), and renal angioplasty (n = 1, 4.5%). The technical success was 100%. There were no major or minor adverse access site, bleeding, or neurological complications at 30 days. This study suggests visceral endovascular interventions performed in morbidly obese patients are safe and feasible.

Minor laparoscopic liver resection as day-case surgery (without overnight hospitalisation): a pilot study.

PubMed

Rebibo, Lionel; Leourier, Pauline; Badaoui, Rachid; Le Roux, Fabien; Lorne, Emmanuel; Regimbeau, Jean-Marc

2018-06-25

Day-case surgery (DCS) has become increasingly popular over recent years, as has laparoscopic liver resection (LLR) for the treatment of benign or malignant liver tumours. The purpose of this prospective study was to demonstrate the feasibility of minor LLR as DCS. Prospective, intention-to-treat, non-randomised study of patients undergoing minor LLR between July 2015 and December 2017. Exclusion criteria were resection by laparotomy, major LLR, difficult locations for minor LLR, history of major abdominal surgery, hepatobiliary procedures without liver parenchyma resection, cirrhosis with Child > A and/or portal hypertension, significant medical history and exclusion criteria for DCS. The primary endpoint was the unplanned overnight admission rate. Secondary endpoints were the reason for exclusion, complication data, criteria for DCS evaluation, satisfaction and compliance with the protocol. One hundred sixty-seven patients underwent liver resection during the study period. LLR was performed in 92 patients (55%), as DCS in 23 patients (25%). Reasons for minor LLR were liver metastasis (n = 9), hepatic adenoma (n = 5), hepatocellular carcinoma (n = 4), ciliated hepatic foregut cyst (n = 2) and other benign tumours (n = 3). All day-case minor LLR, except two patients, consisted of single wedge resection, while one patient underwent left lateral sectionectomy. There were four unplanned overnight admissions (17.4%), one unscheduled consultation (4.3%), two hospital readmissions (8.6%) and no major complications/mortality. Compliance with the protocol was 69.5%. Satisfaction rate was 91%. In selected patients, day-case minor LLR is feasible with acceptable complication and readmission rates. Day-case minor LLR can therefore be legitimately proposed in selected patients.

A prospective randomized open-label crossover trial of regional citrate anticoagulation vs. anticoagulation free liver dialysis by the Molecular Adsorbents Recirculating System

PubMed Central

2012-01-01

Introduction The Molecular Adsorbent Recycling System (MARS) is used to treat patients with liver failure. Observational data suggest that citrate anticoagulation during MARS is feasible. Comparative studies on the optimal anticoagulation regimen during MARS are lacking. The aim of the current study was to evaluate two heparin-free anticoagulation regimens. Methods We performed a prospective randomized open-label crossover study of regional citrate anticoagulation against no anticoagulation. Ten patients (age 55 ± 11 years) with liver failure undergoing MARS treatment were included. The primary endpoint was completion of MARS sessions. Secondary endpoints included treatment efficacy and safety. Longevity of MARS treatment was plotted as a Kaplan-Meier estimate. Fisher's exact test was used for contingency table analysis. Results Of a total of 27 6-hour sessions, four sessions had to be terminated prematurely, three due to occlusive clotting of the extracorporeal circuit and one due to uncontrollable bleeding from the vascular access site. All four events occurred in the group without anticoagulation. Between group comparison demonstrated citrate anticoagulation to significantly increase the likelihood of completed MARS treatment (Fisher's exact test, P 0.04). This translates into higher bilirubin reduction ratios when citrate was applied (reduction ratio 0.25 vs. 0.15, P 0.02). Systemic ionized calcium concentrations were significantly reduced during citrate anticoagulation (P < 0.001) but remained within a safe range. We observed no major adverse events. Conclusions Regional citrate anticoagulation in patients with liver failure is feasible. Citrate anticoagulation provides superior patency of the extracorporeal circuit. Avoidance of anticoagulation during MARS results in significant loss of treatment efficacy, due to treatment downtime. Additional studies are required to identify the optimal anticoagulation regimen for extracorporeal circulation in patients with liver failure. PMID:22305273

Methodology for energy strategy to prescreen the feasibility of Ground Source Heat Pump systems in residential and commercial buildings in the United States

DOE PAGES

Cho, Soolyeon; Ray, Saurabh; Im, Piljae; ...

2017-09-21

Geothermal resources have potential to reduce dependence on fossil fuels. The viability of geothermal heat pumps or ground source heat pumps (GSHPs) is significant as a potential alternative energy source with substantial savings potential. While the prospect of these systems is promising for energy efficiency, careful feasibility analysis is required before implementation. Here, this paper presents the results of evaluation of the application feasibility for GSHPs in buildings across seven climate zones in three United States regions. A comprehensive methodology is developed to measure the integrated feasibility of GSHPs using compiled data for energy use intensity, energy cost and designmore » parameters. Four different feasibility metrics are utilized: ground temperature, outdoor weather condition, energy savings potential, and cost benefits. For each metric, a corresponding feasibility score system is developed. The defined integrated feasibility score classifies the locations into five different feasibility levels ranging from Fair (0–20), Moderate (21–40), Good (41–60), High (61–80), and Very High (81–100). Conclusions show the GSHP feasibility level is High for 3 sites, Good for 8 sites and Moderate for 4 sites. Through the methodology, it is possible to develop a practical energy strategy for more economic and sustainable GSHP systems at an early design stage in the various viewpoints of geometries, climate conditions, operational factors, and energy costs.« less

Methodology for energy strategy to prescreen the feasibility of Ground Source Heat Pump systems in residential and commercial buildings in the United States

DOE Office of Scientific and Technical Information (OSTI.GOV)

Cho, Soolyeon; Ray, Saurabh; Im, Piljae

Geothermal resources have potential to reduce dependence on fossil fuels. The viability of geothermal heat pumps or ground source heat pumps (GSHPs) is significant as a potential alternative energy source with substantial savings potential. While the prospect of these systems is promising for energy efficiency, careful feasibility analysis is required before implementation. Here, this paper presents the results of evaluation of the application feasibility for GSHPs in buildings across seven climate zones in three United States regions. A comprehensive methodology is developed to measure the integrated feasibility of GSHPs using compiled data for energy use intensity, energy cost and designmore » parameters. Four different feasibility metrics are utilized: ground temperature, outdoor weather condition, energy savings potential, and cost benefits. For each metric, a corresponding feasibility score system is developed. The defined integrated feasibility score classifies the locations into five different feasibility levels ranging from Fair (0–20), Moderate (21–40), Good (41–60), High (61–80), and Very High (81–100). Conclusions show the GSHP feasibility level is High for 3 sites, Good for 8 sites and Moderate for 4 sites. Through the methodology, it is possible to develop a practical energy strategy for more economic and sustainable GSHP systems at an early design stage in the various viewpoints of geometries, climate conditions, operational factors, and energy costs.« less

The Jackson Heart KIDS Pilot Study: Theory-Informed Recruitment in an African American Population.

PubMed

Beech, Bettina M; Bruce, Marino A; Crump, Mary E; Hamilton, Gina E

2017-04-01

Recruitment for large cohort studies is typically challenging, particularly when the pool of potential participants is limited to the descendants of individuals enrolled in a larger, longitudinal "parent" study. The increasing complexity of family structures and dynamics can present challenges for recruitment in offspring. Few best practices exist to guide effective and efficient empirical approaches to participant recruitment. Social and behavioral theories can provide insight into social and cultural contexts influencing individual decision-making and facilitate the development strategies for effective diffusion and marketing of an offspring cohort study. The purpose of this study was to describe the theory-informed recruitment approaches employed by the Jackson Heart KIDS Pilot Study (JHKS), a prospective offspring feasibility study of 200 African American children and grandchildren of the Jackson Heart Study (JHS)-the largest prospective cohort study examining cardiovascular disease among African American adults. Participant recruitment in the JHKS was founded on concepts from three theoretical perspectives-the Diffusion of Innovation Theory, Strength of Weak Ties, and Marketing Theory. Tailored recruitment strategies grounded in participatory strategies allowed us to exceed enrollment goals for JHKS Pilot Study and develop a framework for a statewide study of African American adolescents.

The Jackson Heart KIDS Pilot Study: Theory-Informed Recruitment in an African American Population

PubMed Central

Beech, Bettina M.; Bruce, Marino A.; Crump, Mary E.; Hamilton, Gina E.

2016-01-01

Recruitment for large cohort studies is typically challenging, particularly when the pool of potential participants is limited to the descendants of individuals enrolled in a larger, longitudinal “parent” study. The increasing complexity of family structures and dynamics can present challenges for recruitment in offspring. Few best practices exist to guide effective and efficient empirical approaches to participant recruitment. Social and behavioral theories can provide insight into social and cultural contexts influencing individual decision-making and facilitate the development strategies for effective diffusion and marketing of an offspring cohort study. The purpose of this study was to describe the theory-informed recruitment approaches employed by the Jackson Heart KIDS Pilot Study (JHKS), a prospective offspring feasibility study of 200 African American children and grandchildren of the Jackson Heart Study (JHS)—the largest prospective cohort study examining cardiovascular disease among African American adults. Participant recruitment in the JHKS was founded on concepts from three theoretical perspectives—the Diffusion of Innovation Theory, Strength of Weak Ties, and Marketing Theory. Tailored recruitment strategies grounded in participatory strategies allowed us to exceed enrollment goals for JHKS Pilot Study and develop a framework for a statewide study of African American adolescents. PMID:27129858

Preoperative Accelerated Partial Breast Irradiation for Early-Stage Breast Cancer: Preliminary Results of a Prospective, Phase 2 Trial

DOE Office of Scientific and Technical Information (OSTI.GOV)

Nichols, Elizabeth, E-mail: Enichols1@umm.edu; Kesmodel, Susan B.; Bellavance, Emily

Purpose: To assess the feasibility of utilizing 3-dimensional conformal accelerated partial-breast irradiation (APBI) in the preoperative setting followed by standard breast-conserving therapy. Patients and Methods: This was a prospective trial testing the feasibility of preoperative APBI followed by lumpectomy for patients with early-stage invasive ductal breast cancer. Eligible patients had T1-T2 (<3 cm), N0 tumors. Patients received 38.5 Gy in 3.85-Gy fractions delivered twice daily. Surgery was performed >21 days after radiation therapy. Adjuvant therapy was given as per standard of care. Results: Twenty-seven patients completed treatment. With a median follow-up of 3.6 years (range, 0.5-5 years), there have been no local or regional failures.more » A complete pathologic response according to hematoxylin and eosin stains was seen in 4 patients (15%). There were 4 grade 3 seromas. Patient-reported cosmetic outcome was rated as good to excellent in 79% of patients after treatment. Conclusions: Preoperative 3-dimensional conformal radiation therapy−APBI is feasible and well tolerated in select patients with early-stage breast cancer, with no reported local recurrences and good to excellent cosmetic results. The pathologic response rates associated with this nonablative APBI dose regimen are particularly encouraging and support further exploration of this paradigm.« less

Tracing a Path to the Past: Exploring the Use of Commercial Credit Reporting Data to Construct Residential Histories for Epidemiologic Studies of Environmental Exposures.

PubMed

Hurley, Susan; Hertz, Andrew; Nelson, David O; Layefsky, Michael; Von Behren, Julie; Bernstein, Leslie; Deapen, Dennis; Reynolds, Peggy

2017-02-01

Large-scale environmental epidemiologic studies often rely on exposure estimates based on linkage to residential addresses. This approach, however, is limited by the lack of residential histories typically available for study participants. Our objective was to evaluate the feasibility of using address data from LexisNexis (a division of RELX, Inc., Dayton, Ohio), a commercially available credit reporting company, to construct residential histories for participants in the California Teachers Study (CTS), a prospective cohort study initiated in 1995-1996 to study breast cancer (n = 133,479). We evaluated the degree to which LexisNexis could provide retrospective addresses prior to study enrollment, as well as the concordance with existing prospective CTS addresses ascertained at the time of the completion of 4 self-administered questionnaires. For approximately 80% of CTS participants, LexisNexis provided at least 1 retrospective address, including nearly 25,000 addresses completely encompassed by time periods prior to enrollment. This approach more than doubled the proportion of the study population for whom we had an address of residence during the childbearing years-an important window of susceptibility for breast cancer risk. While overall concordance between the prospective addresses contained in these 2 data sources was good (85%), it was diminished among black women and women under the age of 40 years. © The Author 2017. Published by Oxford University Press on behalf of the Johns Hopkins Bloomberg School of Public Health.

Nonoperative management in children with early acute appendicitis: A systematic review.

PubMed

Xu, Jane; Adams, Susan; Liu, Yingrui Cyril; Karpelowsky, Jonathan

2017-09-01

Appendectomy has remained the gold standard treatment of acute appendicitis for more than 100years. Nonoperative management (NOM) has been shown to be a valid treatment alternative for acute uncomplicated appendicitis in adults. A systematic review of available evidence comparing operative management (OM) and NOM in children with acute uncomplicated appendicitis was performed. Systematic searches of MedLine, Embase, and a clinical trial register (https://clinicaltrials.gov/) were performed in March 2016. Only articles that studied NOM for uncomplicated appendicitis in children were included. Data generation was performed independently by two authors, and quality was assessed using the rating schema by the Oxford Centre for Evidence-Based Medicine. 15 articles were selected: four retrospective analyses, four prospective cohort studies, four prospective nonrandomized comparative trials and one randomized controlled trial (RCT). Initial success of the NOM groups (a cure within two weeks of intervention) ranged from 58 to 100%, with 0.1-31.8% recurrence at one year. Although present literature is scarce, publications support the feasibility of further studies investigating NOM of acute uncomplicated appendicitis in children. Higher quality prospective RCTs with larger sample sizes and robust randomization methods, studying the noninferiority of NOM with antibiotics compared with OM are required to establish its utility. This manuscript is a systematic review and thus assigned the lowest evidence used from the manuscripts analyzed which is a Level IV. Copyright © 2017. Published by Elsevier Inc.

Implementation of a Regional Virtual Tumor Board: A Prospective Study Evaluating Feasibility and Provider Acceptance

PubMed Central

Marshall, Christy L.; Petersen, Nancy J.; Naik, Aanand D.; Velde, Nancy Vander; Artinyan, Avo; Albo, Daniel; Berger, David H.

2014-01-01

Abstract Background: Tumor board (TB) conferences facilitate multidisciplinary cancer care and are associated with overall improved outcomes. Because of shortages of the oncology workforce and limited access to TB conferences, multidisciplinary care is not available at every institution. This pilot study assessed the feasibility and acceptance of using telemedicine to implement a virtual TB (VTB) program within a regional healthcare network. Materials and Methods: The VTB program was implemented through videoconference technology and electronic medical records between the Houston (TX) Veterans Affairs Medical Center (VAMC) (referral center) and the New Orleans (LA) VAMC (referring center). Feasibility was assessed as the proportion of completed VTB encounters, rate of technological failures/mishaps, and presentation duration. Validated surveys for confidence and satisfaction were administered to 36 TB participants to assess acceptance (1–5 point Likert scale). Secondary outcomes included preliminary data on VTB utilization and its effectiveness in providing access to quality cancer care within the region. Results: Ninety TB case presentations occurred during the study period, of which 14 (15%) were VTB cases. Although one VTB encounter had a technical mishap during presentation, all scheduled encounters were completed (100% completion rate). Case presentations took longer for VTB than for regular TB cases (p=0.0004). However, VTB was highly accepted with mean scores for satisfaction and confidence of 4.6. Utilization rate of VTB was 75%, and its effectiveness was equivalent to that observed for non-VTB cases. Conclusions: Implementation of VTB is feasible and highly accepted by its participants. Future studies should focus on widespread implementation and validating the effectiveness of this model. PMID:24845366

[Present situation and prospect of enhanced recovery after surgery in pancreatic surgery].

PubMed

Feng, Mengyu; Zhang, Taiping; Zhao, Yupei

2017-05-25

Enhanced recovery after surgery is a multimodal perioperative strategy according to the evidence-based medicine and multidisciplinary collaboration, aiming to improve the restoration of functional capacity after surgery by reducing surgical stress, optimal control of pain, early oral diet and early mobilization. Compared with other sub-specialty in general surgery, pancreatic surgery is characterized by complex disease, highly difficult procedure and more postoperative complications. Accordingly, pancreatic surgery shares a slow development in enhanced recovery after surgery. In this review, the feasibility, safety, application progress, prospect and controversy of enhanced recovery after surgery in pancreatic surgery are discussed.

[Hysteroscopic fallopian tube sterilization procedure: feasibility and one-year follow-up].

PubMed

Gibon, E; Lopès, P; Linet, T; Martigny, H; Orieux, C; Philippe, H-J

2006-03-01

Hysteroscopic flexible micro-insert (Essure) is an ambulatory improvement of fallopian tube sterilization, which is a deliberated suppression of fertility. The aim of this study was an evaluation of feasibility (learning curve) and the first year outcome of this method. This prospective study, carried out between February 2002 and March 2003, included patients who were matching with manufacturer recommendations. One surgeon only realized all the device placements. Fifty patients were included (one year follow-up). Mean age was 41 (+/-3.3), mean parity was 2.7 (+/-0.8). Mean time needed for device placement was 26 minutes (+/-6.5) and was reduced with increased experience. Six failures of placement (12%) were related, because of submucus leiomyomas, proximal tubal stenotic disease or too retroverted uterus. Only 5 patients (11,4%) described intensive pelvic pain during the placement. The only case of device expulsion benefited from a successful second placement. The one-year follow-up showed no significant difference of body weight increasing, duration or quantity of menstruation, neither significant pelvic pain nor vaginal bleeding. Tolerance was rated at least at "somewhat satisfied". There have been no pregnancies reported in 670 woman-months of effectiveness. Our results agree in any point with those of larger studies. We think that hysteroscopy micro-insert placement is not only reserved to specialized centers but also to any gynecologist who is used to performing hysteroscopy because of its feasibility.

A review of social media methods and lessons learned from the National Children's Study.

PubMed

Burke-Garcia, Amelia; Winseck, Kate; Jouvenal, Leslie Cooke; Hubble, David; Kulbicki, Kathryn M

2017-08-01

Given the reach and influence of social media, the National Children's Study Vanguard Study evaluated the feasibility, acceptability, and cost of using social media to support participant retention. We describe a social media experiment designed to assess the impact of social media on participant retention, discuss several key considerations for integrating social media into longitudinal research, and review factors that may influence engagement in research-related social media. User participation varied but was most active when at launch. During the short life of the private online community, a total of 39 participants joined. General enthusiasm about the prospect of the online community was indicated. There were many lessons learned throughout the process in areas such as privacy, security, and Institutional Review Board clearance. These are described in detail. The opportunity to engage participants in longitudinal research using online social networks is enticing; however, more research is needed to consider the feasibility of their use in an ongoing manner. Recommendations are presented for future research seeking to use social media to improve retention in longitudinal research.

Feasibility of allogeneic stem-cell transplantation after azacitidine bridge in higher-risk myelodysplastic syndromes and low blast count acute myeloid leukemia: results of the BMT-AZA prospective study.

PubMed

Voso, M T; Leone, G; Piciocchi, A; Fianchi, L; Santarone, S; Candoni, A; Criscuolo, M; Masciulli, A; Cerqui, E; Molteni, A; Finelli, C; Parma, M; Poloni, A; Carella, A M; Spina, F; Cortelezzi, A; Salvi, F; Alessandrino, E P; Rambaldi, A; Sica, S

2017-07-01

Allogeneic stem-cell transplantation (HSCT) is the only curative treatment in myelodysplastic syndromes (MDS). Azacitidine (AZA) is increasingly used prior to HSCT, however in Europe it is only approved for patients who are not eligible for HSCT. We conducted a phase II multicenter study to prospectively evaluate the feasibility of HSCT after treatment with AZA in 70 patients with a myelodysplastic syndrome (MDS), 19 with acute myeloid leukemia (AML), and 8 with chronic myelomonocytic leukemia (CMML). After a median of four cycles (range 1-11): 24% of patients achieved complete remission, 14% partial remission, 8% hematologic improvement, 32% had stable and 22% progressive disease. Ten patients discontinued treatment before the planned four cycles, due to an adverse event in nine cases. A HSC donor was identified in 73 patients, and HSCT was performed in 54 patients (74% of patients with a donor). Main reasons for turning down HSCT were lack of a donor, an adverse event, or progressive disease (9, 12, and 16 patients, respectively). At a median follow-up of 20.5 months from enrolment, response to AZA was the only independent prognostic factor for survival. Compared to baseline assessment, AZA treatment did not affect patients' comorbidities at HSCT: the HCT-CI remained stable in 62% patients, and worsened or improved in 23% and 15% of patients, respectively. Our study shows that HSCT is feasible in the majority of patients with HR-MDS/AML/CMML-2 after AZA treatment. As matched unrelated donor was the most frequent source of donor cells, the time between diagnosis and HSCT needed for donor search could be 'bridged' using azacitidine. These data show that AZA prior to HSCT could be a better option than intensive chemotherapy in higher-risk MDS. The trial has been registered with the EudraCT number 2010-019673-1. © The Author 2017. Published by Oxford University Press on behalf of the European Society for Medical Oncology. All rights reserved. For permissions, please email: journals.permissions@oup.com.

Development of an occupational advice intervention for patients undergoing lower limb arthroplasty (the OPAL study).

PubMed

Baker, Paul; Coole, Carol; Drummond, Avril; McDaid, Catriona; Khan, Sayeed; Thomson, Louise; Hewitt, Catherine; McNamara, Iain; McDonald, David; Fitch, Judith; Rangan, Amar

2018-06-28

There are an increasing number of patients of working age undergoing hip and knee replacements. Currently there is variation in the advice and support given about sickness absence, recovery to usual activities and return to work after these procedures. Earlier, sustainable, return to work improves the health of patients and benefits their employers and society. An intervention that encourages and supports early recovery to usual activities, including work, has the potential to reduce the health and socioeconomic burden of hip and knee replacements. A two-phase research programme delivered over 27 months will be used to develop and subsequently test the feasibility of an occupational advice intervention to facilitate return to work and usual activities in patients undergoing lower limb arthroplasty. The 2 phases will incorporate a six-stage intervention mapping process: Phase 1: Intervention mapping stages 1-3: 1 Needs assessment (including rapid evidence synthesis, prospective cohort analysis and structured stakeholder interviews) 2 Identification of intended outcomes and performance objectives 3 Selection of theory-based methods and practical strategies Phase 2: Intervention mapping stages 4-6: 4 Development of components and materials for the occupational advice intervention using a modified Delphi process 5 Adoption and implementation of the intervention 6 Evaluation and feasibility testing The study will be undertaken in four National Health Service (NHS) hospitals in the United Kingdom and two Higher Education Institutions. OPAL (Occupational advice for Patients undergoing Arthroplasty of the Lower limb) aims to develop an occupational advice intervention to support early recovery to usual activities including work, which is tailored to the requirements of patients undergoing hip and knee replacements. The developed intervention will then be assessed with a specific focus on evaluating its feasibility as a potential trial intervention to improve speed of recovery to usual activities including work. The study was registered retrospectively with the International Standard Randomised Controlled Trials Number (ISRCTN): 27426982 (Date 20/12/2016) and the International prospective register of systematic reviews (PROSPERO): CRD42016045235 (Date 04/08/2016).

Evaluation of Oral and Maxillofacial Surgery Residents' Operative Skills: Feasibility and Engagement Study Using SIMPL Software for a Mobile Phone.

PubMed

Kaban, Leonard B; Cappetta, Alyssa; George, Brian C; Lahey, Edward T; Bohnen, Jordan D; Troulis, Maria J

2017-10-01

There are no universally accepted tools to evaluate operative skills of surgical residents in a timely fashion. The purpose of this study was to determine the feasibility of using a smartphone application, SIMPL (System for Improving and Measuring Procedural Learning), developed by a multi-institutional research collaborative, to achieve a high rate of timely operative evaluations and resident communication and to collect performance data. The authors hypothesized that these goals would be achieved because the process is convenient and efficient. This was a prospective feasibility and engagement study using SIMPL to evaluate residents' operative skills. SIMPL requires the attending surgeon to answer 3 multiple-choice questions: 1) What level of help (Zwisch Scale) was required by the trainee? 2) What was the level of performance? 3) How complex was the case? The evaluator also can dictate a narrative. The sample was composed of 3 faculty members and 3 volunteer senior residents. Predictor variables were the surgeons, trainees, and procedures performed. Outcome variables included number and percentage of procedures performed by faculty-and-resident pairs assessed, time required to complete assessments, time lapsed to submission, percentage of assessments with narratives, and residents' response rates. From March through June 2016, 151 procedures were performed in the operating room by the faculty-and-resident teams. There were 107 assessments submitted (71%). Resident response (self-assessment) to faculty evaluations was 81%. Recorded time to complete assessments (n = 75 of 107) was shorter than 2 minutes. The time lapsed to submission was shorter than 72 hours (100%). Dictations were submitted for 35 evaluations (33%). Data for the type of help, performance, and complexity of cases were collected for each resident. SIMPL facilitates timely intraoperative evaluations of surgical skills, engagement by faculty and residents, and collection of detailed procedural data. Additional prospective trials to assess this tool further are planned. Copyright © 2017 American Association of Oral and Maxillofacial Surgeons. Published by Elsevier Inc. All rights reserved.

Simplifying Logistics and Avoiding the Unnecessary in Patients With Breast Cancer Undergoing Sentinel Node Biopsy. A Prospective Feasibility Trial of the Preoperative Injection of Super Paramagnetic Iron Oxide Nanoparticles.

PubMed

Karakatsanis, A; Olofsson, H; Stålberg, P; Bergkvist, L; Abdsaleh, S; Wärnberg, F

2018-06-01

Sentinel node is routinely localized with the intraoperative use of a radioactive tracer, involving challenging logistics. Super paramagnetic iron oxide nanoparticle is a non-radioactive tracer with comparable performance that could allow for preoperative localization, would simplify the procedure, and possibly be of value in axillary mapping before neoadjuvant treatment. The current trial aimed to determine the a priori hypothesis that the injection of super paramagnetic iron oxide nanoparticles in the preoperative period for the localization of the sentinel node is feasible. This is a prospective feasibility trial, conducted from 9 September 2014 to 22 October 2014 at Uppsala University Hospital. In all, 12 consecutive patients with primary breast cancer planned for resection of the primary and sentinel node biopsy were recruited. Super paramagnetic iron oxide nanoparticles were injected in the preoperative visit in the outpatient clinic. The radioactive tracer ( 99 mTc) and the blue dye were injected perioperatively in standard fashion. A volunteer was injected with super paramagnetic iron oxide nanoparticles to follow the decline in the magnetic signal in the sentinel node over time. The primary outcome was successful sentinel node detection. Super paramagnetic iron oxide nanoparticles' detection after preoperative injection (3-15 days) was successful in all cases (100%). In the volunteer, axillary signal was presented for 4 weeks. No adverse effects were noted. Conclusion and relevance: Preoperative super paramagnetic iron oxide nanoparticles' injection is feasible and leads to successful detection of the sentinel node. That may lead to simplified logistics as well as the identification, sampling, and marking of the sentinel node in patients planned for neoadjuvant treatment.

Phase I/II prospective trial of cancer-specific imaging using ultrasound spectrum analysis tissue-type imaging to guide dose-painting prostate brachytherapy.

PubMed

Ennis, Ronald D; Quinn, S Aidan; Trichter, Frieda; Ryemon, Shannon; Jain, Anudh; Saigal, Kunal; Chandrashekhar, Sarayu; Romas, Nicholas A; Feleppa, Ernest J

2015-01-01

To assess the technical feasibility, toxicity, dosimetry, and preliminary efficacy of dose-painting brachytherapy guided by ultrasound spectrum analysis tissue-type imaging (TTI) in low-risk, localized prostate cancer. Fourteen men with prostate cancer who were candidates for brachytherapy as sole treatment were prospectively enrolled. Treatment planning goal was to escalate the tumor dose to 200% with a modest de-escalation of dose to remaining prostate compared with our standard. Primary end points included technical feasibility of TTI-guided brachytherapy and equivalent or better toxicity compared with standard brachytherapy. Secondary end points included dose escalation to tumor regions and de-escalated dose to nontumor regions on the preimplant plan, negative prostate biopsy at 2 years, and freedom from biochemical failure. Thirteen of fourteen men successfully completed the TTI-guided brachytherapy procedure for a feasibility rate of 93%. A software malfunction resulted in switching one patient from TTI-guided to standard brachytherapy. An average of 2.7 foci per patient was demonstrated and treated with an escalated dose. Dosimetric goals on preplan were achieved. One patient expired from unrelated causes 65 days after brachytherapy. Toxicity was at least as low as standard brachytherapy. Two-year prostate biopsies were obtained from six men; five (83%) were definitively negative, one showed evidence of disease with treatment effect, and none were positive. No patients experienced biochemical recurrence after a median followup of 31.5 (24-52) months. We have demonstrated that TTI-guided dose-painting prostate brachytherapy is technically feasible and results in clinical outcomes that are encouraging in terms of low toxicity and successful biochemical disease control. Copyright © 2015 American Brachytherapy Society. Published by Elsevier Inc. All rights reserved.

Pilot feasibility of an mHealth system for conducting ecological momentary assessment of mood-related symptoms following traumatic brain injury.

PubMed

Juengst, Shannon B; Graham, Kristin M; Pulantara, I Wayan; McCue, Michael; Whyte, Ellen M; Dicianno, Brad E; Parmanto, Bambang; Arenth, Patricia M; Skidmore, Elizabeth R D; Wagner, Amy K

2015-01-01

This study assessed pilot feasibility and validity of a mobile health (mHealth) system for tracking mood-related symptoms after traumatic brain injury (TBI). A prospective, repeated measures design was used to assess compliance with daily ecological momentary assessments (EMA) conducted via a smartphone application over an 8-week period. An mHealth system was developed specifically for individuals with TBI and utilized previously validated tools for depressive and anxiety symptoms (Patient Health Questionnaire-9, Generalized Anxiety Disorder-7). Feasibility was assessed in 20 community-dwelling adults with TBI via an assessment of compliance, satisfaction and usability of the smartphone applications. The authors also developed and implemented a clinical patient safety management mechanism for those endorsing suicidality. Participants correctly completed 73.4% of all scheduled assessments, demonstrating good compliance. Daily assessments took <2 minutes to complete. Participants reported high satisfaction with smartphone applications (6.3 of 7) and found them easy to use (6.2 of 7). Comparison of assessments obtained via telephone-based interview and EMA demonstrated high correlations (r = 0.81-0.97), supporting the validity of conducting these assessments via smartphone application in this population. EMA conducted via smartphone demonstrates initial feasibility among adults with TBI and presents numerous opportunities for long-term monitoring of mood-related symptoms in real-world settings.

New prospective 4D-CT for mitigating the effects of irregular respiratory motion

NASA Astrophysics Data System (ADS)

Pan, Tinsu; Martin, Rachael M.; Luo, Dershan

2017-08-01

Artifact caused by irregular respiration is a major source of error in 4D-CT imaging. We propose a new prospective 4D-CT to mitigate this source of error without new hardware, software or off-line data-processing on the GE CT scanner. We utilize the cine CT scan in the design of the new prospective 4D-CT. The cine CT scan at each position can be stopped by the operator when an irregular respiration occurs, and resumed when the respiration becomes regular. This process can be repeated at one or multiple scan positions. After the scan, a retrospective reconstruction is initiated on the CT console to reconstruct only the images corresponding to the regular respiratory cycles. The end result is a 4D-CT free of irregular respiration. To prove feasibility, we conducted a phantom and six patient studies. The artifacts associated with the irregular respiratory cycles could be removed from both the phantom and patient studies. A new prospective 4D-CT scanning and processing technique to mitigate the impact of irregular respiration in 4D-CT has been demonstrated. This technique can save radiation dose because the repeat scans are only at the scan positions where an irregular respiration occurs. Current practice is to repeat the scans at all positions. There is no cost to apply this technique because it is applicable on the GE CT scanner without new hardware, software or off-line data-processing.

Soro West: A non-seismically defined, fault cut-off prospect in the Papuan Fold and Thrust Belt, Papua New Guinea

DOE Office of Scientific and Technical Information (OSTI.GOV)

Robinson, W.F.; Swift, C.M. Jr.

Soro West is a fault cut-off prospect located in the frontal portion of the Papuan Fold and Thrust Belt. Prospective Toro and Imburu sandstones are interpreted to be in the hanging wall of the Soro Thrust. Truncation against the thrust, both updip and through lateral ramps, provides the trapping mechanism. The Soro West Prospect was defined using geological, geochemical, remote sensing, and geophysical data. The definition and location of the trap is a primary risk and work was focused on this aspect. Surface geological data (lithology, strikes, and dips) topography and synthetic aperture radar imagery were incorporated into the evaluation.more » Statistical curvature analysis techniques helped define the shape of the structure and the locations of the lateral ramps. Strontium isotope analyses of Darai Limestone surface samples refined erosional levels using a locally-derived reference curve. Severe karst precludes the acquisition of coherent surface seismic data, so the primary geophysical tool used was magnetotellurics (MT). A detailed, pre-survey feasibility study defined expected responses from alternative structural models. The MT data demonstrated that the limestone at surface is underlain by thick conductive clastics and not another Darai Limestone sheet. The data also constrained the range of fault cut-off positions significantly. Multiple, three-dimensionally consistent, restorable alternative structural models were created using results from all analyses. These led to a positive assessment of the prospect and an exploratory test is to be drilled in 1996.« less

Acute pancreatitis patient registry to examine novel therapies in clinical experience (APPRENTICE): an international, multicenter consortium for the study of acute pancreatitis.

PubMed

Papachristou, Georgios I; Machicado, Jorge D; Stevens, Tyler; Goenka, Mahesh Kumar; Ferreira, Miguel; Gutierrez, Silvia C; Singh, Vikesh K; Kamal, Ayesha; Gonzalez-Gonzalez, Jose A; Pelaez-Luna, Mario; Gulla, Aiste; Zarnescu, Narcis O; Triantafyllou, Konstantinos; Barbu, Sorin T; Easler, Jeffrey; Ocampo, Carlos; Capurso, Gabriele; Archibugi, Livia; Cote, Gregory A; Lambiase, Louis; Kochhar, Rakesh; Chua, Tiffany; Tiwari, Subhash Ch; Nawaz, Haq; Park, Walter G; de-Madaria, Enrique; Lee, Peter J; Wu, Bechien U; Greer, Phil J; Dugum, Mohannad; Koutroumpakis, Efstratios; Akshintala, Venkata; Gougol, Amir

2017-01-01

We have established a multicenter international consortium to better understand the natural history of acute pancreatitis (AP) worldwide and to develop a platform for future randomized clinical trials. The AP patient registry to examine novel therapies in clinical experience (APPRENTICE) was formed in July 2014. Detailed web-based questionnaires were then developed to prospectively capture information on demographics, etiology, pancreatitis history, comorbidities, risk factors, severity biomarkers, severity indices, health-care utilization, management strategies, and outcomes of AP patients. Between November 2015 and September 2016, a total of 20 sites (8 in the United States, 5 in Europe, 3 in South America, 2 in Mexico and 2 in India) prospectively enrolled 509 AP patients. All data were entered into the REDCap (Research Electronic Data Capture) database by participating centers and systematically reviewed by the coordinating site (University of Pittsburgh). The approaches and methodology are described in detail, along with an interim report on the demographic results. APPRENTICE, an international collaboration of tertiary AP centers throughout the world, has demonstrated the feasibility of building a large, prospective, multicenter patient registry to study AP. Analysis of the collected data may provide a greater understanding of AP and APPRENTICE will serve as a future platform for randomized clinical trials.

A new challenge in clinical research in childhood ALL: the prospective meta-analysis strategy for intergroup collaboration.

PubMed

Valsecchi, M G; Masera, G

1996-12-01

We consider the problems arising in clinical research on childhood acute lymphoblastic leukemia (ALL). Given the therapeutic progress achieved over the last few decades, any improvement in the outcome for the majority of children with ALL is difficult to assess with the usual size trials. Furthermore, the progress in genetics and molecular biology has now led to the identification of subgroups of children, typically with rare characteristics, for whom new treatments still await evaluation. For both these aspects of clinical research, there is an increasing need for international intergroup cooperation. After a discussion on the role of retrospective meta-analysis and randomized controlled trials in ALL research, we suggest that intergroup studies could be made more feasible, but still scientifically rigorous, by adopting a strategy of prospective meta-analysis. This strategy can be described as follows: i) different groups prospectively plan to ask the same randomized question within their protocols which may differ in other aspects, and to pool their data in order to evaluate treatment effect; ii) the management of the study can be de-centralized, by allowing each group to be responsible for conducting its own protocol. We would like to stimulate the debate on the methodological and practical aspects of research perspectives in ALL (and in pediatric oncology).

The Feasibility and Impact of Routine Combined Limited Transthoracic Echocardiography and Lung Ultrasound on Diagnosis and Management of Patients Admitted to ICU: A Prospective Observational Study.

PubMed

Haji, Kavi; Haji, Darsim; Canty, David J; Royse, Alistair G; Tharmaraj, Dhaksha; Azraee, Meor; Hopkins, Lynda; Royse, Collin F

2018-02-01

Limited transthoracic echocardiography (TTE) and lung ultrasound increasingly is performed in the intensive care unit (ICU), though used in a goal-directed rather than routine manner. Prospective observational study. Tertiary ICU. Ninety-three critically ill participants within 24 hours of admission to ICU. A treating intensivist documented a clinical diagnosis and management plan before and after combined limited TTE and lung ultrasound. Ultrasound was performed by an independent intensivist and checked for accuracy offline by a second reviewer. Ultrasound images were interpretable in 99%, with good interobserver agreement. The hemodynamic diagnosis was altered in 66% of participants, including new (14%) or altered (25%) abnormal states or exclusion of clinically diagnosed abnormal state (27%). Valve pathology of at least moderate severity was diagnosed for mitral regurgitation (7%), aortic stenosis (1%), aortic stenosis and mitral regurgitation (1%), tricuspid regurgitation (3%), and 1 case of mitral regurgitation was excluded. Lung pathology diagnosis was changed in 58% of participants including consolidation (13%), interstitial syndrome (4%), and pleural effusion (23%), and exclusion of clinically diagnosed consolidation (6%), interstitial syndrome (3%), and pleural effusion (9%). Management changed in 65% of participants including increased (12%) or decreased (23%) fluid therapy, initiation (10%), changing (6%) or cessation (9%) of inotropic, vasoactive or diuretic drugs, non-invasive ventilation (3%), and pleural drainage (2%). Routine screening of patients with combined limited TTE and lung ultrasound on admission to ICU is feasible and frequently alters diagnosis and management. Copyright © 2018 Elsevier Inc. All rights reserved.

[Feasibility and effectiveness of laparoscopic right colectomy with extracorporeal anastomosis].

PubMed

Feroci, F; Lenzi, E; Kröning, K C; Moraldi, L; Cantafio, S; Borrelli, A; Giaconi, G; Scatizzi, M

2011-02-01

Despite the laparoscopic right hemicolectomy has been validated by many randomized prospective trials, clear evidences on the validity of the totally mini-invasive technique, namely, through intracorporeal anastomosis, are still lacking. The aim of this study was the assessment of short-term outcome within three months from laparoscopic right colectomy with intra- or extra-corporeal anastomosis. With no exclusion, all patients undergoing laparoscopic right hemicolectomy at our institution have been enrolled in this study. Group A included patients undergoing laparoscopic right hemicolectomy with extracorporeal anastomosis (LAC) and Group B, included patients undergoing laparoscopic right hemicolectomy with intracorporeal anastomosis (TLC). Patients' data, surgery details, results of postoperative period and histological tests have been prospectively recorded in a database and analysed. Between December 2006 and December 2008, 45 patients underwent right hemicolectomy, 21 with extracorporeal anastomosis and 24 had intracorporeal ones. As to patients' characteristics and histopathological results there are no difference between the groups. Anastomotic dehiscence occurred one in group A and one in group B (P>0.05). Both patients underwent reoperation. We recorded 6 postoperative ileus with vomiting in the LAC group and only 1 in the TLC group (P<0.05). The incidence of Non-Surgical Site Complications (NSSC) was of 4.54% in LAC group and 8.33% in TLC group (P>0.05). Hospitalization was of 5 days for both groups. In conclusion, we believe that this technique is feasible in terms of safety; it doesn't significatively affect the length of surgical procedure and guarantees maintenance of oncological radicality standards of reference. Besides it significatively improves quality of the post-operative period.

Totally intracorporeal delta-shaped B-I anastomosis following laparoscopic distal gastrectomy using the Tri-Staple™ reloads on the manual Ultra handle: a prospective cohort study with historical controls.

PubMed

Man-I, Mariko; Suda, Koichi; Kikuchi, Kenji; Tanaka, Tsuyoshi; Furuta, Shimpei; Nakauchi, Masaya; Ishikawa, Ken; Ishida, Yoshinori; Uyama, Ichiro

2015-11-01

A delta-shaped anastomosis in totally laparoscopic Billroth I gastrectomy could be performed easily and sufficiently using only laparoscopic linear staplers. However, the restricted maneuverability and severe blurring of these staplers along with their limited hemostability induced strain. In this study, we determined the feasibility and safety of performing delta-shaped anastomosis using the Endo GIA™ Reloads with Tri-Staple™ Technology combined with Endo GIA™ Ultra Universal stapler (Tri-Staple) with a particular focus on short-term surgical outcomes. We performed a single-institutional prospective interventional study (UMIN 000008014). The Tri-Staple was prospectively used on 23 consecutive patients who underwent a curative totally laparoscopic Billroth I gastrectomy with delta-shaped anastomosis. These patients were matched with the 19 patients previously treated using the ENDOPATH(®) ETS Articulating Linear Cutters (ETS) on clinical and demographic characteristics. There were no differences between the groups in anastomosis-related local complications, morbidity, non-anastomosis-related local complications, total systemic complications, and short-term outcomes with the exception of significantly reduced blood loss in the Tri-Staple group (ETS vs. Tri-Staple: 37 [10-306] vs. 15 [5-210] mL, p = 0.02). Intraoperative bleeding from the staple line was significantly reduced in the Tri-Staple group. The postoperative drain indwelling period (ETS vs. Tri-Staple, 6 [4-10] vs. 4 [2-43] days, p = 0.032), fasting period (5 [3-7] vs. 3 [3-24] days, p = 0.022), and hospital stay (14 [10-47] vs. 11 [6-58] days, p = 0.025) were significantly shorter in the Tri-Staple group. There was no mortality in this series. Acceleration assessed as indices of blurring of stapler tip might have a significant adverse influence on staple-line bleeding at stapling sites. Totally laparoscopic Billroth I distal gastrectomy using Tri-Staple was feasible and safe with favorable short-term surgical outcomes. Reduced blurring while stapling may be a novel endpoint which newly developed stapling devices should target.

Ketogenic diet in migraine: rationale, findings and perspectives.

PubMed

Barbanti, Piero; Fofi, Luisa; Aurilia, Cinzia; Egeo, Gabriella; Caprio, Massimiliano

2017-05-01

Ketogenic diet (KD) is an established treatment for refractory pediatric epilepsy and a promising therapy for diverse neurological diseases. Clinical data on KD in migraine-obtained from 150 patients investigated in case reports and prospective studies-suggest that KD may be a rapid onset effective prophylaxis for episodic and chronic migraine. KD would contribute to restore brain excitability and metabolism and to counteract neuroinflammation in migraine, although its precise mechanism is still unclear. Randomized controlled studies are needed to confirm the usefulness of KD in migraine and to investigate its optimal duration, repeatability, feasibility in normal weight subjects, efficacy in pediatric population and association to conventional migraine prophylaxis.

Prospects for inferring pairwise relationships with single nucleotide polymorphisms

Treesearch

Jeffery C. Glaubitz; O. Eugene, Jr. Rhodes; J. Andrew DeWoody

2003-01-01

An extraordinarily large number of single nucleotide polymorphisms (SNPs) are now available in humans as well as in other model organisms. Technological advancements may soon make it feasible to assay hundreds of SNPs in virtually any organism of interest. One potential application of SNPs is the determination of pairwise genetic relationships in populations without...

The Prospects for the Implementation of School-Based Financial Management in Taiwan

ERIC Educational Resources Information Center

Ho, Hsuan-fu

2010-01-01

The current approach to solving educational problems in Taiwan is to adopt policies employed in Western countries. However, given the very different cultural and educational environment of Asia, not all policies effective in Western countries are necessarily applicable to schools in Taiwan. Therefore, an examination of the feasibility and…

The application and development of artificial intelligence in smart clothing

NASA Astrophysics Data System (ADS)

Wei, Xiong

2018-03-01

This paper mainly introduces the application of artificial intelligence in intelligent clothing. Starting from the development trend of artificial intelligence, analysis the prospects for development in smart clothing with artificial intelligence. Summarize the design key of artificial intelligence in smart clothing. Analysis the feasibility of artificial intelligence in smart clothing.

Standardised versus individualised multiherb Chinese herbal medicine for oligomenorrhoea and amenorrhoea in polycystic ovary syndrome: a randomised feasibility and pilot study in the UK

PubMed Central

Flower, Andrew; Prescott, Philip; Wing, Trevor; Moore, Michael; Lewith, George

2017-01-01

Objectives To explore feasibility of a randomised study using standardised or individualised multiherb Chinese herbal medicine (CHM) for oligomenorrhoea and amenorrhoea in women with polycystic ovary syndrome (PCOS), to pilot study methods and to obtain clinical data to support sample size calculations. Design Prospective, pragmatic, randomised feasibility and pilot study with participant and practitioner blinding. Setting 2 private herbal practices in the UK. Participants 40 women diagnosed with PCOS and oligomenorrhoea or amenorrhoea following Rotterdam criteria. Intervention 6 months of either standardised CHM or individualised CHM, 16 g daily taken orally as a tea. Main outcome measures Our primary objective was to determine whether oligomenorrhoea and amenorrhoea were appropriate as the primary outcome measures for the main study. Estimates of treatment effects were obtained for menstrual rate, body mass index (BMI), weight and hirsutism. Data were collected regarding safety, feasibility and acceptability. Results Of the 40 participants recruited, 29 (72.5%) completed the study. The most frequently cited symptoms of concern were hirsutism, weight and menstrual irregularity. Statistically significant improvements in menstrual rates were found at 6 months within group for both standardised CHM (mean difference (MD) 0.18±0.06, 95% CI 0.06 to 0.29; p=0.0027) and individualised CHM (MD 0.27±0.06, 95% CI 0.15 to 0.39; p<0.001), though not between group (p=0.26). No improvements were observed for BMI nor for weight in either group. Improvements in hirsutism scores found within group for both groups were not statistically significant between group (p=0.09). Liver and kidney function and adverse events data were largely normal. Participant feedback suggests changing to tablet administration could facilitate adherence. Conclusions A CHM randomised controlled trial for PCOS is feasible and preliminary data suggest that both individualised and standardised multiherb CHMs have similar safety profiles and clinical effects on promoting menstrual regularity. These data will inform the design of a study in primary care that will incorporate an appropriate control. Trial registration number ISRCTN 31072075; Results. PMID:28159846

Presurgical mapping of basal cell carcinoma or squamous cell carcinoma by confocal laser endomicroscopy compared to traditional micrographic surgery: a single-centre prospective feasibility study.

PubMed

Schulz, Alexandra; Daali, Samira; Javed, Mehreen; Fuchs, Paul Christian; Brockmann, Michael; Igressa, Alhadi; Charalampaki, Patra

2016-12-01

At present, no ideal diagnostic tools exist in the market to excise cancer tissue with the required safety margins and to achieve optimal aesthetic results using tissue-conserving techniques. In this prospective study, confocal laser endomicroscopy (CLE) and the traditional gold standard of magnifying glasses (MG) were compared regarding the boundaries of in vivo basal cell carcinoma and squamous cell carcinoma. Tumour diameters defined by both methods were measured and compared with those determined by histopathological examination. Nineteen patients were included in the study. The CLE technique was found to be superior to excisional margins based on MG only. Re-excision was required in 68% of the cases following excision based on MG evaluation, but only in 27% of the cases for whom excision margins were based on CLE. Our results are promising regarding the distinction between tumour and healthy surrounding tissue, and indicate that presurgical mapping of basal cell carcinoma and squamous cell carcinoma is possible. The tool itself should be developed further with special attention to early detection of skin cancer.

Prospective Clinical Study of Precision Oncology in Solid Tumors.

PubMed

Sohal, Davendra P S; Rini, Brian I; Khorana, Alok A; Dreicer, Robert; Abraham, Jame; Procop, Gary W; Saunthararajah, Yogen; Pennell, Nathan A; Stevenson, James P; Pelley, Robert; Estfan, Bassam; Shepard, Dale; Funchain, Pauline; Elson, Paul; Adelstein, David J; Bolwell, Brian J

2015-11-09

Systematic studies evaluating clinical benefit of tumor genomic profiling are lacking. We conducted a prospective study in 250 patients with select solid tumors at the Cleveland Clinic. Eligibility required histopathologic diagnosis, age of 18 years or older, Eastern Cooperative Oncology Group performance status 0-2, and written informed consent. Tumors were sequenced using FoundationOne (Cambridge, MA). Results were reviewed at the Cleveland Clinic Genomics Tumor Board. Outcomes included feasibility and clinical impact. Colorectal (25%), breast (18%), lung (13%), and pancreatobiliary (13%) cancers were the most common diagnoses. Median time from consent to result was 25 days (range = 3-140). Of 223 evaluable samples, 49% (n = 109) of patients were recommended a specific therapy, but only 11% (n = 24) received such therapy: 12 on clinical trials, nine off-label, three on-label. Lack of clinical trial access (n = 49) and clinical deterioration (n = 29) were the most common reasons for nonrecommendation/nonreceipt of genomics-driven therapy. © The Author 2015. Published by Oxford University Press. All rights reserved. For Permissions, please e-mail: journals.permissions@oup.com.

Applicability of transoral endoscopic parathyroidectomy through vestibular route for primary sporadic hyperparathyroidism: A South Indian experience.

PubMed

Bhargav, P R K; Sabaretnam, M; Amar, V; Devi, N Vimala

2018-05-04

Primary hyperparathyroidism is one of the most common endocrine disorders requiring surgical parathyroidectomy for its definitive treatment. Surgical exploration is traditionally performed through conventional open neck approach. A wide range of minimal access and minimally invasive endoscopic techniques (gas less and with gas) have been attempted in the past two decades. In this context, we evaluated the feasibility and safety of an innovative transoral endoscopic parathyroidectomy (EP) technique, which represents a paradigm shift in transluminal endocrine surgery. This is a prospective study conducted at a tertiary care Endocrine Surgery Department in South India between May 2016 and August 2017. We employed a novel transoral, lower vestibular route for EP. All the clinical, investigative, operative, pathological and post-operative data were collected from our prospectively filled database. Statistical analysis was performed with SPSS 20.0 version. Under inhalational general anaesthesia, access to the neck was obtained with 3 ports (central frenulotomy and two lateral port sites), dissected in subplatysmal plane and insufflated with 6 mm Hg CO 2 for working space. Rest of surgical steps is similar to conventional open parathyroidectomy. Out of the 38 hyperparathyroidism cases operated during the study, 12 (32%) were operated by this technique. Mean operative time was 112 ± 15 min (95-160). The post-operative course was uneventful with no major morbidity, hypocalcemia or recurrent laryngeal nerve palsy. Cure and diagnosis were confirmed by> 50% fall in intraoperative parathyroid hormone levels and histopathology (all were benign solitary adenomas). Through this study, we opine that this novel transoral vestibular route parathyroidectomy is a feasibly applicable approach for primary sporadic hyperparathyroidism, especially with solitary benign adenomas.

Efficacy of early switch from intravenous to oral antimicrobials in patients with aspiration pneumonia: A prospective observational study.

PubMed

Uni, Masahiro; Nishimura, Naoki; Yamano, Yasuhiko; Ishikawa, Genta; Kitamura, Atsushi; Tomishima, Yutaka; Jinta, Torahiko; Takahashi, Osamu; Deshpande, Gautam; Chohnabayashi, Naohiko

2015-09-01

Previous reports have documented the efficacy of an early switch from intravenous to oral antimicrobials in community-acquired pneumonia, but not aspiration pneumonia. Therefore, we assessed the feasibility and efficacy of these newly developed criteria for community-acquired pneumonia in patients with aspiration pneumonia. This prospective observational study included consecutive patients admitted with aspiration pneumonia over a 10-month period at St. Luke's International Hospital; we excluded patients that required intensive care. The criteria for an early switch were stability of vital signs (temperature ≤ 38 °C; respiratory rate ≤ 24 breaths/min; pulse rate ≤ 100 beats/min for >24 h) and a successful swallow evaluation (repetitive saliva swallowing test score ≥ 2; modified water swallowing test score ≥ 4). Our primary endpoint was successful completion of antimicrobial treatment 30 days after the switch, without reversion to intravenous antimicrobials. Our anticipated success rate was set as 60-75%, based on a previous study. Of the 70 patients admitted with aspiration pneumonia, 32 (45.7%) were excluded, and 38 (54.3%) met the inclusion criteria. Of these 38 patients, 29 (76.3%) met the switch criteria. The median duration of hospital stay for the included patients was 16 (5-30) days and 30 (12-68) days, respectively (P=0.03). Among patients who met the switch criteria, 26 (89.7%) completed oral treatment successfully while 3 (10.3%) reverted to intravenous antimicrobials. Approximately 75% of patients met the switch criteria; of these, nearly 90% underwent safe conversion to oral therapy. These results demonstrate the efficacy and feasibility of our switch criteria. Copyright © 2015. Published by Elsevier B.V.

Prospective analysis of laparoscopic versus open radical nephrectomy for renal tumours more than 7 cm.

PubMed

Khan, Mohd Mubashir Ali; Patel, Rajkumar Ashokkumar; Jain, Nitesh; Balakrishnan, Arunkumar; Venkataraman, Murali

2018-03-23

To analyse the feasibility of laparoscopic radical nephrectomy (LRN) for renal tumours> 7 cm and to compare the operative and oncologic outcomes with open radical nephrectomy (ORN). This was a prospective, observational, comparative study. The study was conducted at a tertiary care super-speciality hospital. All the patients who underwent radical nephrectomy for> 7 cm renal tumours during a period of 2 years (April 2012 to May 2014) were included in the study. Thirty patients were included in each ORN and LRN group. Pre-operative, intra-operative and post-operative data for all these patients were collected and analysed. Statistical Package for the Social Sciences (SPSS, version 11.0 for Windows, Chicago, IL). Mean age of patients in ORN and LRN groups was 57.3 ± 6.1 years and 54.9 ± 5.7 years, respectively (P = 0.220). As compared to ORN, LRN had less drop in post-operative haemoglobin (1.39 ± 0.55 g/dl vs. 4.07 ± 1.023 g/dl, P < 0.05), less drop in haematocrit value (4.7 ± 3.25% vs. 9.5 ± 5.13%, P < 0.05), less analgesic requirement for tramadol hydrochloride (165 ± 74.5 mg vs. 260 ± 181.66 mg) and less mean hospital stay (4.2 days vs. 6.1 days, P < 0.05). There was no statistically significant difference in post-operative complication rate and recurrence-free survival over a median follow-up of 17 months (93.9% - LRN vs. 90% - ORN) Conclusions: LRN for large renal tumours is feasible and achieves oncologic outcomes similar to that obtained with ORN.

Feasibility of a cardiologist-only approach to sedation for electrical cardioversion of atrial fibrillation: a randomized, open-blinded, prospective study.

PubMed

Guerra, Federico; Pavoni, Ilaria; Romandini, Andrea; Baldetti, Luca; Matassini, Maria Vittoria; Brambatti, Michela; Luzi, Mario; Pupita, Giuseppe; Capucci, Alessandro

2014-10-20

Sedation with propofol should be administered by personnel trained in advanced airway management. To overcome this limitation, the use of short acting benzodiazepines by cardiologists spread widely, causing concerns about the safety of this procedure in the absence of anesthesiology assistance. The aim of the study was to compare feasibility of a cardiologist-only approach with an anesthesiologist-assisted sedation protocol during elective direct-current cardioversion (DCC) of persistent atrial fibrillation (AF). This prospective, open-blinded, randomized study included 204 patients, which were admitted for scheduled cardioversion of persistent AF, and randomized in a 1:1 fashion to either propofol or midazolam treatment arm. Patients in the propofol group underwent DCC with anesthesiologist assistance, while patients in the midazolam group saw the cardiologist as the only responsible for both sedation and DCC. Twenty-three adverse events occurred: 13 in the propofol group and 10 in the midazolam group (p=NS). Most of them were related to bradyarrhythmias and respiratory depressions. There was no need of intubation or other advanced resuscitation techniques in any of these patients. No differences were found regarding procedure tolerability and safety endpoints between the two groups. DCC procedures with anesthesiology support were burdened by higher delay from scheduled time and higher costs. Sedation with midazolam administered by cardiologist-only appears to be as safe as sedation with propofol and anesthesiologist assistance. Adverse events were few in both groups and easily handled by the cardiologist alone. A cardiologist-only approach to sedation provides less procedural delay, thus being easier to schedule and correlated with fewer costs. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.

Fast 3-T MR-guided transrectal prostate biopsy using an in-room tablet device for needle guide alignment: a feasibility study.

PubMed

Overduin, Christiaan G; Heidkamp, Jan; Rothgang, Eva; Barentsz, Jelle O; de Lange, Frank; Fütterer, Jurgen J

2018-05-22

To assess the feasibility of adding a tablet device inside the scanner room to assist needle-guide alignment during magnetic resonance (MR)-guided transrectal prostate biopsy. Twenty patients with one cancer-suspicious region (CSR) with PI-RADS score ≥ 4 on diagnostic multiparametric MRI were prospectively enrolled. Two orthogonal scan planes of an MR fluoroscopy sequence (~3 images/s) were aligned to the CSR and needle-guide pivoting point. Targeting was achieved by manipulating the needle-guide under MR fluoroscopy feedback on the in-room tablet device. Technical feasibility and targeting success were assessed. Complications and biopsy procedure times were also recorded. Needle-guide alignment with the in-room tablet device was technically successful in all patients and allowed sampling after a single alignment step in 19/20 (95%) CSRs (median size 14 mm, range: 4-45). Biopsy cores contained cancer in 18/20 patients. There were no per-procedural or post-biopsy complications. Using the tablet device, the mean time to first biopsy was 5.8 ± 1.0 min and the mean total procedure time was 23.7 ± 4.1 min. Use of an in-room tablet device to assist needle-guide alignment was feasible and safe during MR-guided transrectal prostate biopsy. Initial experience indicates potential for procedure time reduction. • Performing MR-guided prostate biopsy using an in-room tablet device is feasible. • CSRs could be sampled after a single alignment step in 19/20 patients. • The mean procedure time for biopsy with the tablet device was 23.7 min.

Planning study for Merkel cell carcinoma based on the relapse pattern.

PubMed

Hoeller, Ulrike; Schubert, Tina; Mueller, Thomas; Budach, Volker; Ghadjar, Pirus; Brenner, Winfried; Kuschke, Wolf

2017-04-01

To develop a technique for radiation (RT) of in-transit path ways (IT) in Merkel cell carcinoma. In the planning study, IT were ink-marked on the skin during sentinel lymphscintigraphy and wire-marked in planning-CT. Pre- and post-operative planning-CTs were acquired. The clinical target volume (CTV) included tumor bed plus safety margin, IT and draining nodes, the planning volume (PTV) the CTV plus 0.5-1cm margin. VMAT plans with 2-3 arcs were analyzed. A planning study was performed for five pts. including two pts. with primary tumor (PT) in head and neck, 1 pt. each with PT of elbow, forearm and upper leg respectively. Plans showed satisfactory PTV coverage: D mean 100%±0%, D 98% 92.4%±2.24%, homogeneity index (HI) 0.095±0.01, conformation number (CN) 0.84±0.01 and conformality index (CI) 0.95±0.01. The planning study confirms feasibility of highly conformal irradiation of IT pathways based on individualized target delineation. Currently, patients referred for non-metastatic MCC are encouraged to enroll in a prospective clinical study that evaluates the feasibility of radiation of IT pathways. Copyright © 2017 Elsevier B.V. All rights reserved.

Feasibility of Using Mobile ECG Recording Technology to Detect Atrial Fibrillation in Low-Resource Settings.

PubMed

Evans, Grahame F; Shirk, Arianna; Muturi, Peter; Soliman, Elsayed Z

2017-12-01

Screening for atrial fibrillation (AF), a major risk factor for stroke that is on the rise in Africa, is becoming increasingly critical. This study sought to examine the feasibility of using mobile electrocardiogram (ECG) recording technology to detect AF. In this prospective observational study, we used a mobile ECG recorder to screen 50 African adults (66% women; mean age 54.3 ± 20.5 years) attending Kijabe Hospital (Kijabe, Kenya). Five hospital health providers involved in this study's data collection process also completed a self-administered survey to obtain information on their access to the Internet and mobile devices, both factors necessary to implement ECG mobile technology. Outcome measures included feasibility (completion of the study and recruitment of the patients on the planned study time frame) and the yield of the screening by the mobile ECG technology (ability to detect previously undiagnosed AF). Patients were recruited in a 2-week period as planned; only 1 of the 51 patients approached refused to participate (98% acceptance rate). All of the 50 patients who agreed to participate completed the test and produced readable ECGs (100% study completion rate). ECG tracings of 4 of the 50 patients who completed the study showed AF (8% AF yield), and none had been previously diagnosed with AF. When asked about continuous access to Internet and personal mobile devices, almost all of the health care providers surveyed answered affirmatively. Using mobile ECG technology in screening for AF in low-resource settings is feasible, and can detect a significant proportion of AF cases that will otherwise go undiagnosed. Further study is needed to examine the cost-effectiveness of this approach for detection of AF and its effect on reducing the risk of stroke in developing countries. Copyright © 2016 World Heart Federation (Geneva). Published by Elsevier B.V. All rights reserved.

Feasibility and reliability of the SHOT: A short scale for measuring pretreatment severity of alcohol withdrawal in the emergency department.

PubMed

Gray, Sara; Borgundvaag, Bjug; Sirvastava, Anita; Randall, Ian; Kahan, Meldon

2010-10-01

Use of a symptom-triggered scale to measure the severity of alcohol withdrawal could reduce the rate of seizures and other complications. The current standard scale, the Clinical Institute of Withdrawal Assessment (CIWA), takes a mean (±SD) of 5 minutes to complete, requiring 30 minutes of nursing time per patient when multiple measures are required. The objective was to assess the feasibility and reliability of a brief scale of alcohol withdrawal severity. The SHOT is a brief scale designed to assess alcohol withdrawal in the emergency department (ED). It includes four items: sweating, hallucinations, orientation, and tremor (SHOT). It was developed based on a literature review and a consensus process by emergency and addiction physicians. The SHOT was first piloted in one ED, and then a prospective observational study was conducted at a different ED to measure its feasibility and reliability. Subjects included patients who were in alcohol withdrawal. One nurse administered the SHOT and CIWA, and the physician repeated the SHOT independently. The SHOT was done only at baseline, before treatment was administered. In the pilot study (12 patients), the SHOT took 1 minute to complete on average, and the CIWA took 5 minutes. Sixty-one patients participated in the prospective study. For the SHOT and the CIWA done by the same nurse, the kappa was 0.88 (95% confidence interval [CI] = 0.52 to 1.0; p < 0.0001), and the Pearson's r was 0.71 (p < 0.001). The kappa for the nurse's CIWA score and the physician's SHOT score was 0.61 (95% CI = 0.25 to 0.97; p < 0.0006), and the Pearson's r was 0.48 (p = 0.002). The SHOTs performed by the nurse and physician agreed on the need for benzodiazepine treatment in 30 of 37 cases (82% agreement, kappa = 0.35, 95% CI = 0.03 to 0.67; p < 0.02). The mean (±SD) time taken by nurses and physicians to complete the SHOT was 1 (± 0.52) minute (median = 0.6 minutes). Seventeen percent of patients scored positive on the SHOT for hallucinations or disorientation. The SHOT has potential as a feasible and acceptable tool for measuring pretreatment alcohol withdrawal severity in the ED. Further research is needed to validate the SHOT, to assess the utility of serial measurements of the SHOT, and to demonstrate that its use reduces length of stay and improves clinical outcomes. © 2010 by the Society for Academic Emergency Medicine.

First series of total robotic hysterectomy (TRH) using new integrated table motion for the da Vinci Xi: feasibility, safety and efficacy.

PubMed

Giannini, Andrea; Russo, Eleonora; Mannella, Paolo; Palla, Giulia; Pisaneschi, Silvia; Cecchi, Elena; Maremmani, Michele; Morelli, Luca; Perutelli, Alessandra; Cela, Vito; Melfi, Franca; Simoncini, Tommaso

2017-08-01

To present the first case series of total robotic hysterectomy (TRH), using integrated table motion (ITM), which is a new feature comprising a unique operating table by Trumpf Medical that communicates wirelessly with the da Vinci Xi surgical system. ITM has been specifically developed to improve multiquadrant robotic surgery such as that conducted in colorectal surgery. Between May and October 2015, a prospective post-market study was conducted on ITM in the EU in 40 cases from different specialties. The gynecological study group comprised 12 patients. Primary endpoints were ITM feasibility, safety and efficacy. Ten patients underwent TRH. Mean number of ITM moves was three during TRH; there were 31 instances of table moves in the ten procedures. Twenty-eight of 31 ITM moves were made to gain internal exposure. The endoscope remained inserted during 29 of the 31 table movements (94%), while the instruments remained inserted during 27 of the 31 moves (87%). No external instrument collisions or other problems related to the operating table were noted. There were no ITM safety-related observations and no adverse events. This preliminary study demonstrated the feasibility, safety and efficacy of ITM for the da Vinci Xi surgical system in TRH. ITM was safe, with no adverse events related to its use. Further studies will be useful to define the real role and potential benefit of ITM in gynecological surgery.

Counseling and exercise intervention for smoking reduction in patients with schizophrenia: a feasibility study.

PubMed

Bernard, Paquito Philippe Noel; Esseul, Elodie Christine; Raymond, Laurent; Dandonneau, Loic; Xambo, Jean-Jacques; Carayol, Marion Sara; Ninot, Gregory Jean-Marie Guilyn

2013-02-01

Smoking cessation is possible for individuals with schizophrenia but the relapse rate is high. It is necessary to develop more flexible approaches to help these patients. The aim of this study was to examine the feasibility of an intervention approach that integrates counseling and exercise for participants with schizophrenia or schizoaffective disorder. A single group prospective design was used in this study. A sample of inpatients with schizophrenia or schizoaffective disorder participated in a program called "oxygen group", a program combining five sessions of smoking reduction counseling and three sessions of moderate intensity exercise over an 8-week period. Tobacco consumption, motivation, carbon monoxide level, anxiety and depression, smoking self-efficacy, nicotine dependence and waist circumference were measured pre- and post-intervention. Participants reported their satisfaction with the study characteristics after completion of the intervention. Smoking consumption and CO level were assessed at 6-week post-intervention follow-up. Twelve individuals (mean age 45.7±10.8years) were recruited. Participant attendance was 81.3%. There were no dropouts. Significant decreases were found for tobacco consumption (P=.04) and CO rate (P=.003) at the end of the intervention and were maintained at 6-week follow-up. Compared to baseline levels, there were no changes in depression and anxiety. Smoking cessation motivation increased significantly. This intervention appears feasible and acceptable to patients with schizophrenia and there were promising findings regarding smoking reduction. Larger trials to test the intervention are warranted. Copyright © 2013 Elsevier Inc. All rights reserved.

Private sector surgical training: feasibility through the lens of appendicectomy.

PubMed

Yap, Raymond; Cullinan, Mark

2017-12-01

Training in medicine and surgery has been a public hospital responsibility in Australia. Increasing specialist training needs has led to pressure on speciality societies to find additional training posts, with one utilized solution being the establishment of private hospital training. This growing use has been despite no previously published evaluations of private hospital training in Australia. This article seeks to evaluate the feasibility of surgical training in private hospitals in appendicectomy. Data were prospectively collected on registrar involvement in appendicectomy cases at a single private tertiary institution over 1 year. These data were divided into groups according to registrar involvement and analysed, looking at training caseload, operating theatre time and complications. A total of 122 cases were analysed over the study period. Registrars were more likely to have increased primary operator responsibility if they were an accredited versus unaccredited registrar (P = 0.04) and if the case was open versus laparoscopic (P < 0.001). There was an increase of 15% in total procedure time when the registrar was involved (P = 0.04). There was no significant difference in complications whether the registrar was involved or not. Training in the private sector in Australia appears feasible, with a small loss of efficiency and no increase in complications. This article hopes to further encourage implementation and evaluation of private sector training programs to expand current training positions. Further studies, in different specialty and procedural domains, are needed to assess and evaluate the ongoing feasibility of private sector training. © 2016 Royal Australasian College of Surgeons.

Utility of the electronic information resource UpToDate for clinical decision-making at bedside rounds.

PubMed

Phua, J; See, K C; Khalizah, H J; Low, S P; Lim, T K

2012-02-01

Clinical questions often arise at daily hospital bedside rounds. Yet, little information exists on how the search for answers may be facilitated. The aim of this prospective study was, therefore, to evaluate the overall utility, including the feasibility and usefulness of incorporating searches of UpToDate, a popular online information resource, into rounds. Doctors searched UpToDate for any unresolved clinical questions during rounds for patients in general medicine and respiratory wards, and in the medical intensive care unit of a tertiary teaching hospital. The nature of the questions and the results of the searches were recorded. Searches were deemed feasible if they were completed during the rounds and useful if they provided a satisfactory answer. A total of 157 UpToDate searches were performed during the study period. Questions were raised by all ranks of clinicians from junior doctors to consultants. The searches were feasible and performed immediately during rounds 44% of the time. Each search took a median of three minutes (first quartile: two minutes, third quartile: five minutes). UpToDate provided a useful and satisfactory answer 75% of the time, a partial answer 17% of the time and no answer 9% of the time. It led to a change in investigations, diagnosis or management 37% of the time, confirmed what was originally known or planned 38% of the time and had no effect 25% of the time. Incorporating UpToDate searches into daily bedside rounds was feasible and useful in clinical decision-making.

Integrated Bio-behavioral Approach to Improve Adherence to Pre-exposure Prophylaxis and Reduce HIV Risk in People Who Use Drugs: A Pilot Feasibility Study.

PubMed

Shrestha, Roman; Altice, Frederick L; Karki, Pramila; Copenhaver, Michael M

2018-03-26

This study reports the feasibility, acceptability, and preliminary efficacy of the bio-behavioral community-friendly health recovery program-an integrated, HIV prevention intervention to improve pre-exposure prophylaxis (PrEP) adherence and HIV-risk reduction behaviors among high-risk people who use drugs. We used a within-subjects, pretest-posttest follow-up design to recruit participants, who were HIV-uninfected, methadone-maintained and reported HIV-risk behaviors and had initiated PrEP (n = 40; males: 55%). Participants were assessed at baseline (T 0 ), immediately post-intervention (4 weeks: T 4 ) and 4 weeks post-intervention (T 8 ). Immediately after completing the four weekly intervention groups, participants underwent a post-intervention assessment including in-depth qualitative interviews. Feasibility was high, assessed by participant willingness to enroll (90.1%) and retention (95%). Results showed that participants were highly satisfied and perceived the intervention as valuable and acceptable [mean: 81.3 (range 0-100)]. Significant enhancements in self-reported PrEP adherence [F(2,74) = 7.500, p = 0.001] and PrEP-related knowledge [F(2,74) = 3.828, p = 0.026] were observed. Drug-related (e.g., injection of drugs, sharing of injection equipment) and sex-related (e.g., number of sexual partners, condomless sex) risk behaviors were reduced, while information, motivation, and behavioral skills (IMB) constructs increased. The results support feasibility and high acceptability and support further examination of the efficacy of this combination bio-behavioral intervention in a prospective clinical trial.

How to Establish and Follow up a Large Prospective Cohort Study in the 21st Century--Lessons from UK COSMOS.

PubMed

Toledano, Mireille B; Smith, Rachel B; Brook, James P; Douglass, Margaret; Elliott, Paul

2015-01-01

Large-scale prospective cohort studies are invaluable in epidemiology, but they are increasingly difficult and costly to establish and follow-up. More efficient methods for recruitment, data collection and follow-up are essential if such studies are to remain feasible with limited public and research funds. Here, we discuss how these challenges were addressed in the UK COSMOS cohort study where fixed budget and limited time frame necessitated new approaches to consent and recruitment between 2009-2012. Web-based e-consent and data collection should be considered in large scale observational studies, as they offer a streamlined experience which benefits both participants and researchers and save costs. Commercial providers of register and marketing data, smartphones, apps, email, social media, and the internet offer innovative possibilities for identifying, recruiting and following up cohorts. Using examples from UK COSMOS, this article sets out the dos and don'ts for today's cohort studies and provides a guide on how best to take advantage of new technologies and innovative methods to simplify logistics and minimise costs. Thus a more streamlined experience to the benefit of both research participants and researchers becomes achievable.

How to Establish and Follow up a Large Prospective Cohort Study in the 21st Century - Lessons from UK COSMOS

PubMed Central

Toledano, Mireille B.; Smith, Rachel B.; Brook, James P.; Douglass, Margaret; Elliott, Paul

2015-01-01

Large-scale prospective cohort studies are invaluable in epidemiology, but they are increasingly difficult and costly to establish and follow-up. More efficient methods for recruitment, data collection and follow-up are essential if such studies are to remain feasible with limited public and research funds. Here, we discuss how these challenges were addressed in the UK COSMOS cohort study where fixed budget and limited time frame necessitated new approaches to consent and recruitment between 2009-2012. Web-based e-consent and data collection should be considered in large scale observational studies, as they offer a streamlined experience which benefits both participants and researchers and save costs. Commercial providers of register and marketing data, smartphones, apps, email, social media, and the internet offer innovative possibilities for identifying, recruiting and following up cohorts. Using examples from UK COSMOS, this article sets out the dos and don’ts for today's cohort studies and provides a guide on how best to take advantage of new technologies and innovative methods to simplify logistics and minimise costs. Thus a more streamlined experience to the benefit of both research participants and researchers becomes achievable. PMID:26147611

A phase I/II clinical trial for the hybrid of intracavitary and interstitial brachytherapy for locally advanced cervical cancer.

PubMed

Murakami, Naoya; Kato, Shingo; Nakano, Takashi; Uno, Takashi; Yamanaka, Takeharu; Sakurai, Hideyuki; Yoshimura, Ryoichi; Hiratsuka, Junichi; Kuroda, Yuki; Yoshio, Kotaro; Itami, Jun

2016-08-17

This paper describes about a study protocol of phase I/II multicenter prospective clinical trial evaluating the feasibility and efficacy of the hybrid of intracavitary and interstitial brachytherapy (HBT) for locally advanced uterine cervical cancer patients. Patients with histologically confirmed FIGO stage IB2, IIA2, IIB, and IIIB uterine cervical carcinoma width of which is larger than 5 cm assessed by MRI will be entered to this clinical trial. Protocol therapy is 30-30.6 Gy in 15-17 fractions of whole pelvic radiotherapy concurrent with weekly CDDP (40 mg/m(2)), followed by 24 Gy in 4 fractions of HBT and central shield EBRT up to 50-50.4 Gy in 25-28 fractions. Tumor width is assessed again within one week before the first HBT and if the tumor width is larger than 4 cm, patients proceed to the secondary registration. In phase I section, feasibility of this will be investigated. If less than 10 % out of 20 patients experienced greater than grade 3 acute non-hematologic adverse effects, the study proceeds to phase II part. In phase II part a total of 55 patients will be accrued and the efficacy of the HBT will be investigated comparing with historical control data. If the lower margin of 90 % confidence interval of the 2-year pelvic progression-free survival of the HBT trial is higher than 64 %, the HBT is considered to be more effective than conventional ICBT. The aim of this study is to demonstrate the feasibility and efficacy of the HBT for locally advanced cervical cancer. This trial will clarify the indication, feasibility, and efficacy of this new technique. UMIN000019081 ; Registration date: 2015/9/30.

Simultaneous Assessment of Myocardial Perfusion, Wall Motion, and Deformation during Myocardial Contrast Echocardiography: A Feasibility Study.

PubMed

Zoppellaro, Giacomo; Venneri, Lucia; Khattar, Rajdeep S; Li, Wei; Senior, Roxy

2016-06-01

Ultrasound contrast agents may be used for the assessment of regional wall motion and myocardial perfusion, but are generally considered not suitable for deformation analysis. The aim of our study was to assess the feasibility of deformation imaging on contrast-enhanced images using a novel methodology. We prospectively enrolled 40 patients who underwent stress echocardiography with continuous intravenous infusion of SonoVue for the assessment of myocardial perfusion imaging with flash replenishment technique. We compared longitudinal strain (Lε) values, assessed with a vendor-independent software (2D CPA), on 68 resting contrast-enhanced and 68 resting noncontrast recordings. Strain analysis on contrast recordings was evaluated in the first cardiac cycles after the flash. Tracking of contrast images was deemed feasible in all subjects and in all views. Contrast administration improved image quality and increased the number of segments used for deformation analysis. Lε of noncontrast and contrast-enhanced images were statistically different (-18.8 ± 4.5% and -22.8 ± 5.4%, respectively; P < 0.001), but their correlation was good (ICC 0.65, 95%CI 0.42-0.78). Patients with resting wall-motion abnormalities showed lower Lε values on contrast recordings (-18.6 ± 6.0% vs. -24.2 ± 5.5%, respectively; P < 0.01). Intra-operator and inter-operator reproducibility was good for both noncontrast and contrast images with no statistical differences. Our study shows that deformation analysis on postflash contrast-enhanced images is feasible and reproducible. Therefore, it would be possible to perform a simultaneous evaluation of wall-motion abnormalities, volumes, ejection fraction, perfusion defects, and cardiac deformation on the same contrast recording. © 2016, Wiley Periodicals, Inc.

Integrating Aerobic Training Within Subacute Stroke Rehabilitation: A Feasibility Study

PubMed Central

Sage, Michael D.; Brunton, Karen; Fraser, Julia; Howe, Jo-Anne; Bayley, Mark; Brooks, Dina; McIlroy, William E.; Mansfield, Avril; Inness, Elizabeth L.

2014-01-01

Background Aerobic activity positively affects patients recovering from stroke and is part of best practice guidelines, yet this evidence has not been translated to routine practice. Objective The objective of this study was to evaluate the feasibility of a model of care that integrated aerobic training in an inpatient rehabilitation setting for patients in the subacute stage of stroke recovery. Key elements of the program were personalized training prescription based on submaximal test results and supervision within a group setting. Design This was a prospective cohort study. Methods Participants (N=78) completed submaximal exercise testing prior to enrollment, and the test results were used by their treating physical therapists for exercise prescription. Feasibility was evaluated using enrollment, class attendance, adherence to prescription, and participant perceptions. Results Overall, 31 patients (40%) were referred to and completed the exercise program. Cardiac comorbidities were the main reason for nonreferral to the fitness group. Program attendance was 77%; scheduling conflicts were the primary barrier to participation. The majority of participants (63%) achieved 20 minutes of continuous exercise by the end of the program. No adverse events were reported, all participants felt they benefited from the program, and 80% of the participants expressed interest in continuing to exercise regularly after discharge. Limitations Cardiac comorbidities prevented enrollment in the program for 27% of the admitted patients, and strategies for inclusion in exercise programs in this population should be explored. Conclusions This individualized exercise program within a group delivery model was feasible; however, ensuring adequate aerobic targets were met was a challenge, and future work should focus on how best to include individuals with cardiac comorbidities. PMID:25082924

Feasibility of Extracorporeal Shock Wave Myocardial Revascularization Therapy for Post-Acute Myocardial Infarction Patients and Refractory Angina Pectoris Patients.

PubMed

Myojo, Masahiro; Ando, Jiro; Uehara, Masae; Daimon, Masao; Watanabe, Masafumi; Komuro, Issei

2017-04-06

Extracorporeal shockwave myocardial revascularization (ESMR) is one of the new treatment options for refractory angina pectoris (RAP), and some studies have indicated its effectiveness. A single-arm prospective trial to assess the feasibility of ESMR using Cardiospec for patients with post-acute myocardial infarction (AMI) and RAP was designed and performed. The patients were treated with 9 sessions of ESMR to the ischemic areas for 9 weeks. The feasibility measures included echocardiography; cardiac magnetic resonance imaging; troponin T, creatine kinase-MB (CK-MB), and brain natriuretic peptide testing; and a Seattle Angina Questionnaire (SAQ) survey. Three post-AMI patients and 3 RAP patients were enrolled. The post-AMI patients had already undergone revascularization with percutaneous coronary intervention (PCI) in the acute phase. In two patients, adverse events requiring admission occurred: one a lumbar disc hernia in a post-AMI patient and the other congestive heart failure resulting in death in an RAP patient. No apparent elevations in CK-MB and troponin T levels during the trial were observed. Echocardiography revealed no remarkable changes of ejection fraction; however, septal E/E' tended to decrease after treatments (11.6 ± 4.8 versus 9.2 ± 2.8, P = 0.08). Concerning the available SAQ scores for two RAP patients, one patient reported improvements in angina frequency and treatment satisfaction and the other reported improvements in physical limitations and angina stability. In this feasibility study, ESMR seems to be a safe treatment for both post-AMI patients and RAP patients. The efficacy of ESMR for post-AMI patients remains to be evaluated with additional studies.

DOE Office of Scientific and Technical Information (OSTI.GOV)

Kenda, W.; Shrivastava, V.K.

A Definitional Mission team evaluated the prospects of the US Trade and Development Program (TDP) funding a feasibility study that would assist the Government of Kenya in developing power cogeneration plants in three Kenyan sugar factories and possibly two more that are now in the planning stage or construction. The major Kenyan sugar producing region around Kisumu, on Lake Victoria has climatic conditions that permit cane growing operations ideally suitable for cogeneration of power in sugar factories. The total potentially available capacity from the proposed rehabilitation of the three mills will be approximately 25.15 MW, or 5.7 percent of totalmore » electricity production.« less

Deliberative democracy in health care: current challenges and future prospects.

PubMed

Safaei, Jalil

2015-01-01

There is a vast body of literature on deliberative, participative, or engaged democracy. In the area of health care there is a rapidly expanding literature on deliberative democracy as embodied in various notions of public engagement, shared decision-making (SDM), patient-centered care, and patient/care provider autonomy over the past few decades. It is useful to review such literature to get a sense of the challenges and prospects of introducing deliberative democracy in health care. This paper reviews the key literature on deliberative democracy and SDM in health care settings with a focus on identifying the main challenges of promoting this approach in health care, and recognizing its progress so far for mapping out its future prospects in the context of advanced countries. Several databases were searched to identify the literature pertinent to the subject of this study. A total of 56 key studies in English were identified and reviewed carefully for indications and evidence of challenges and/or promising avenues of promoting deliberative democracy in health care. Time pressure, lack of financial motivation, entrenched professional interests, informational imbalance, practical feasibility, cost, diversity of decisions, and contextual factors are noted as the main challenges. As for the prospects, greater clarity on conception of public engagement and policy objectives, real commitment of the authorities to public input, documenting evidence of the effectiveness of public involvement, development of patient decision supports, training of health professionals in SDM, and use of multiple and flexible methods of engagement leadership suited to specific contexts are the main findings in the reviewed literature. Seeking deliberative democracy in health care is both challenging and rewarding. The challenges have been more or less identified. However, its prospects are potentially significant. Such prospects are more likely to materialize if deliberative democracy is pursued more systematically in the broader sociopolitical domains.

Deliberative democracy in health care: current challenges and future prospects

PubMed Central

Safaei, Jalil

2015-01-01

Background There is a vast body of literature on deliberative, participative, or engaged democracy. In the area of health care there is a rapidly expanding literature on deliberative democracy as embodied in various notions of public engagement, shared decision-making (SDM), patient-centered care, and patient/care provider autonomy over the past few decades. It is useful to review such literature to get a sense of the challenges and prospects of introducing deliberative democracy in health care. Objective This paper reviews the key literature on deliberative democracy and SDM in health care settings with a focus on identifying the main challenges of promoting this approach in health care, and recognizing its progress so far for mapping out its future prospects in the context of advanced countries. Method Several databases were searched to identify the literature pertinent to the subject of this study. A total of 56 key studies in English were identified and reviewed carefully for indications and evidence of challenges and/or promising avenues of promoting deliberative democracy in health care. Results Time pressure, lack of financial motivation, entrenched professional interests, informational imbalance, practical feasibility, cost, diversity of decisions, and contextual factors are noted as the main challenges. As for the prospects, greater clarity on conception of public engagement and policy objectives, real commitment of the authorities to public input, documenting evidence of the effectiveness of public involvement, development of patient decision supports, training of health professionals in SDM, and use of multiple and flexible methods of engagement leadership suited to specific contexts are the main findings in the reviewed literature. Conclusion Seeking deliberative democracy in health care is both challenging and rewarding. The challenges have been more or less identified. However, its prospects are potentially significant. Such prospects are more likely to materialize if deliberative democracy is pursued more systematically in the broader sociopolitical domains. PMID:29355181

Feasibility and Definition of a Limited-Scale Lunar Polar Volatiles Prospecting Mission

NASA Astrophysics Data System (ADS)

Heldmann, J. L.; Elphic, R. C.; Colaprete, A.; Beyer, R. A.; Fong, T.; Cockrell, J.; Pedersen, L.

2011-12-01

The recent Lunar Crater Observing and Sensing Satellite (LCROSS) mission has provided evidence for significant amounts of cold-trapped volatiles in Cabeus crater near the Moon's south pole. Moreover, LRO/Diviner measurements of extremely cold lunar polar surface temperatures imply that volatiles can be stable outside of areas of strict permanent shadow. These discoveries hint at potentially extensive near-surface deposits at both lunar poles. The physical state, composition and distribution of these volatiles are key scientific issues that relate to source and emplacement mechanisms. These issues are also important for enabling lunar in situ resource utilization (ISRU). An assessment of the feasibility of cold-trapped volatile ISRU requires a priori information regarding the location, form, quantity, and potential for extraction of available resources. A small robotic mission to a persistently shadowed but briefly sunlit location with suitable environmental conditions (e.g., short periods of oblique sunlight and subsurface cryogenic temperatures which permit volatile trapping) can help answer these scientific and exploration questions. Key parameters must be defined in order to identify suitable landing sites, plan surface operations, and achieve mission success. To address this need, we have conducted an initial study for a lunar polar volatile prospecting mission, assuming the use of a solar-powered robotic lander and rover. Here we present the mission concept, goals and objectives, and landing site selection analysis for a short-duration, landed, solar-powered mission to a volatile-rich site.

Feasibility and Definition of a Lunar Polar Volatiles Prospecting Mission

NASA Technical Reports Server (NTRS)

Heldmann, Jennifer; Elphic, Richard; Colaprete, Anthony; Fong, Terry; Pedersen, Liam; Beyer, Ross; Cockrell, James

2012-01-01

The recent Lunar Crater Observing and Sensing Satellite (LCROSS) mission has provided evidence for significant amounts of cold trapped volatiles in Cabeus crater near the Moon's south pole. Moreover, LRO/Diviner measurements of extremely cold lunar polar surface temperatures imply that volatiles can be stable outside or areas of strict permanent shadows. These discoveries suggest that orbital neutron spectrometer data point to extensive deposits at both lunar poles. The physical state, composition and distribution of these volatiles are key scientific issues that relate to source and emplacement mechanisms. These issues are also important for enabling lunar in situ resource utilization (ISRU). An assessment of the feasibility of cold-trapped volatile ISRU requires a priori information regarding the location, form, quantity, and potential for extraction of available resources. A robotic mission to a mostly shadowed but briefly .unlit location with suitable environmental conditions (e.g. short periods of oblique sunlight and subsurface cryogenic temperatures which permit volatile trapping) can help answer these scientific and exploration questions. Key parameters must be defined in order to identify suitable landing sites, plan surface operations, and achieve mission success. To address this need, we have conducted an initial study for a lunar polar volatile prospecting mission, assuming the use of a solar-powered robotic lander and rover. Here we present the mission concept, goals and objectives, and landing site selection analysis for a short-duration, landed, solar-powered mission to a potential hydrogen volatile-rich site.

Electromagnetic-Guided MLC Tracking Radiation Therapy for Prostate Cancer Patients: Prospective Clinical Trial Results.

PubMed

Keall, Paul J; Colvill, Emma; O'Brien, Ricky; Caillet, Vincent; Eade, Thomas; Kneebone, Andrew; Hruby, George; Poulsen, Per R; Zwan, Benjamin; Greer, Peter B; Booth, Jeremy

2018-06-01

To report on the primary and secondary outcomes of a prospective clinical trial of electromagnetic-guided multileaf collimator (MLC) tracking radiation therapy for prostate cancer. Twenty-eight men with prostate cancer were treated with electromagnetic-guided MLC tracking with volumetric modulated arc therapy. A total of 858 fractions were delivered, with the dose per fraction ranging from 2 to 13.75 Gy. The primary outcome was feasibility, with success determined if >95% of fractions were successfully delivered. The secondary outcomes were (1) the improvement in beam-target geometric alignment, (2) the improvement in dosimetric coverage of the prostate and avoidance of critical structures, and (3) no acute grade ≥3 genitourinary or gastrointestinal toxicity. All 858 planned fractions were successfully delivered with MLC tracking, demonstrating the primary outcome of feasibility (P < .001). MLC tracking improved the beam-target geometric alignment from 1.4 to 0.90 mm (root-mean-square error). MLC tracking improved the dosimetric coverage of the prostate and reduced the daily variation in dose to critical structures. No acute grade ≥3 genitourinary or gastrointestinal toxicity was observed. Electromagnetic-guided MLC tracking radiation therapy for prostate cancer is feasible. The patients received improved geometric targeting and delivered dose distributions that were closer to those planned than they would have received without electromagnetic-guided MLC tracking. No significant acute toxicity was observed. Copyright © 2018 Elsevier Inc. All rights reserved.

Automated Docking Screens: A Feasibility Study

PubMed Central

2009-01-01

Molecular docking is the most practical approach to leverage protein structure for ligand discovery, but the technique retains important liabilities that make it challenging to deploy on a large scale. We have therefore created an expert system, DOCK Blaster, to investigate the feasibility of full automation. The method requires a PDB code, sometimes with a ligand structure, and from that alone can launch a full screen of large libraries. A critical feature is self-assessment, which estimates the anticipated reliability of the automated screening results using pose fidelity and enrichment. Against common benchmarks, DOCK Blaster recapitulates the crystal ligand pose within 2 Å rmsd 50−60% of the time; inferior to an expert, but respectrable. Half the time the ligand also ranked among the top 5% of 100 physically matched decoys chosen on the fly. Further tests were undertaken culminating in a study of 7755 eligible PDB structures. In 1398 cases, the redocked ligand ranked in the top 5% of 100 property-matched decoys while also posing within 2 Å rmsd, suggesting that unsupervised prospective docking is viable. DOCK Blaster is available at http://blaster.docking.org. PMID:19719084

Automated docking screens: a feasibility study.

PubMed

Irwin, John J; Shoichet, Brian K; Mysinger, Michael M; Huang, Niu; Colizzi, Francesco; Wassam, Pascal; Cao, Yiqun

2009-09-24

Molecular docking is the most practical approach to leverage protein structure for ligand discovery, but the technique retains important liabilities that make it challenging to deploy on a large scale. We have therefore created an expert system, DOCK Blaster, to investigate the feasibility of full automation. The method requires a PDB code, sometimes with a ligand structure, and from that alone can launch a full screen of large libraries. A critical feature is self-assessment, which estimates the anticipated reliability of the automated screening results using pose fidelity and enrichment. Against common benchmarks, DOCK Blaster recapitulates the crystal ligand pose within 2 A rmsd 50-60% of the time; inferior to an expert, but respectrable. Half the time the ligand also ranked among the top 5% of 100 physically matched decoys chosen on the fly. Further tests were undertaken culminating in a study of 7755 eligible PDB structures. In 1398 cases, the redocked ligand ranked in the top 5% of 100 property-matched decoys while also posing within 2 A rmsd, suggesting that unsupervised prospective docking is viable. DOCK Blaster is available at http://blaster.docking.org .

Total mesorectal excision training in soft cadaver: feasibility and clinical application.

PubMed

Tantiphlachiva, Kasaya; Suansawan, Channarong

2006-09-01

The major problem in the treatment of rectal cancer is local recurrence. After the introduction of total mesorectal excision (TME), the recurrent rate decreased from 100% to around 10%. The purpose of the present study was to evaluate the quality of organ and tissue plane preservation in soft cadaver and to assess the feasibility to perform the procedure (mobilization of colon and rectum, total mesorectal excision and stapler anastomosis) in soft cadaver. Colorectal Division, Department of Surgery and Surgical Training Center Department of Anatomy, Faculty of Medicine, Chulalongkorn University. Prospective descriptive study. Seven soft cadavers were used for total mesorectal excision (TME) training. These procedures were performed by 21 participants (1 soft cadaver for 3 participants). The procedures were done under the supervision of experienced colorectal surgeons. The successfulness, satisfaction in performing the procedure and the quality of organ preservation were evaluated using standardized questionnaires. Participants were satisfied about TME training in soft cadaver (mean 8.24-8.71) and rated that soft cadavers were good in terms of internal organs and tissue plane preservation (mean 7.19-8.19) (0 = extremely unsatisfied, 10 = extremely satisfied). Training of TME in soft cadaver is feasible. The similarity in tissue quality (texture, consistency, color) of the preserved organs to that of the living and the good feel of performing the procedure make the trainee better understand the techniques and improve their skills.

Development and evaluation of a holistic surgical head and neck cancer post-treatment follow-up clinic using touchscreen technology-Feasibility study.

PubMed

Semple, C J; Lannon, D; Qudairat, E; McCaughan, E; McCormac, R

2018-03-01

The efficacy of traditional follow-up care is being challenged, as cancer survivors' supportive and psychological needs are often neither identified, nor addressed. This study's aim was to develop a holistic surgical follow-up clinic for oral and oropharyngeal cancer patients were participants completed a disease-specific health-related quality of life tool (UWQOLv4) and item prompt list (Patient Concern Inventory) on a touchscreen computer. Information generated was used to focus the consultation on patient's identified needs and concerns. By means of a prospective non-randomised, pre-test post-test design, this follow-up clinic was evaluated using the patient enablement instrument (PEI) and patient content checklist (PCC). Feasibility was explored from the patient perspective (satisfaction survey) and clinician perspective (qualitative interview). Forty-four consecutive patients were recruited. Findings demonstrating five of the eight topics (overall QOL, emotions, head and neck symptoms, side-effects of treatment, chronic non-specific) on PCC were discussed more frequently, but changes were not statistically significant. The PEI highlighted a trend towards perceived improvement in four of the six items. Using touchscreen computers to aid communication during routine follow-up was reported as both feasible and beneficial by patients and clinicians. Providing a patient-focused follow-up consultation can facilitate the identification of unmet needs, permitting timely and appropriate intervention being initiated. © 2018 John Wiley & Sons Ltd.

Single-step simultaneous side-by-side placement of a self-expandable metallic stent with a 6-Fr delivery system for unresectable malignant hilar biliary obstruction: a feasibility study.

PubMed

Kawakubo, Kazumichi; Kawakami, Hiroshi; Kuwatani, Masaki; Kudo, Taiki; Abe, Yoko; Kawahata, Shuhei; Kubo, Kimitoshi; Kubota, Yoshimasa; Sakamoto, Naoya

2015-02-01

Bilateral self-expandable metallic stent (SEMS) placement for the management of unresectable malignant hilar biliary obstruction (UMHBO) is technically challenging to perform using the existing metallic stents with thick delivery systems. The recently developed 6-Fr delivery systems could facilitate a single-step simultaneous side-by-side placement through the accessory channel of the duodenoscope. The aim of this study was to evaluate the feasibility of this procedure. Between May and September 2013, 13 consecutive patients with UMHBO underwent a single-step simultaneous side-by-side placement of SEMS with the 6-Fr delivery system. The technical success rate, stent patency, and rate of complications were evaluated from the prospectively collected database. Technical success was achieved in 11 (84.6%, 95% confidence interval [CI]: 57.8-95.8) patients. The median procedure time was 25 min. Early and late complications were observed in 23% (one segmental cholangitis and two liver abscesses) and 15% (one segmental cholangitis and one cholecystitis) patients, respectively. Median dysfunction free patency was 263 days (95% CI: 37-263). Five patients (38%) experienced stent occlusion that was successfully managed by endoscopic stent placement. A single-step simultaneous side-by-side placement of SEMS with a 6-Fr delivery system was feasible for the management of UMHBO. © 2014 Japanese Society of Hepato-Biliary-Pancreatic Surgery.

The feasibility of single-port laparoscopic appendectomy using a solo approach: a comparative study

PubMed Central

Kim, Say-June; Choi, Byung-Jo; Jeong, Wonjun

2016-01-01

Purpose To investigate the feasibility and safety of solo surgery with single-port laparoscopic appendectomy, which is termed herein solo-SPLA (solo-single-port laparoscopic appendectomy). Methods This study prospectively collected and retrospectively analyzed data from patients who had undergone either non-solo-SPLA (n = 150) or solo-SPLA (n = 150). Several devices were utilized for complete, skin-to-skin solo-SPSA, including a Lone Star Retractor System and an adjustable mechanical camera holder. Results Operating times were not significantly different between solo- and non-solo-SPLA (45.0 ± 21.0 minutes vs. 46.7 ± 26.1 minutes, P = 0.646). Most postoperative variables were also comparable between groups, including the necessity for intravenous analgesics (0.7 ± 1.2 ampules [solo-SPLA] vs. 0.9 ± 1.5 ampules [non-solo-SPLA], P = 0.092), time interval to gas passing (1.3 ± 1.0 days vs. 1.4 ± 1.0 days, P = 0.182), and the incidence of postoperative complications (4.0% vs. 8.7%, P = 0.153). Moreover, solo-SPLA effectively lowered the operating cost by reducing surgical personnel expenses. Conclusion Solo-SPLA economized staff numbers and thus lowered hospital costs without lengthening of operating time. Therefore, solo-SPLA could be considered a safe and feasible alternative to non-solo-SPLA. PMID:26942160

Public and Private Cooperation in Providing Student Housing. ACCCA Management Report, 1986-7/3.

ERIC Educational Resources Information Center

Cofer, Berdette H.; Cunningham, W. Dean

Prospective students interested in attending Columbia College, which is located in a rural area near Sonora, California, have, until recently, faced a lack of available on- and off-campus housing. In 1983, a local developer expressed an interest in building and operating student housing on campus. After determining the feasibility and legality of…

Immune tolerance: critical issues of factor dose, purity and treatment complications.

PubMed

DiMichele, D M

2006-12-01

The current practice of immune tolerance induction (ITI) therapy has been largely influenced by the results of small institutional studies and three large registries. However, many questions remain. Successful outcome predictors for ITI in haemophilia A have been suggested by the analyses of two of these registries. Among these predictors, factor VIII (FVIII) dose/dosing regimen remains a controversial outcome parameter, demonstrating a strong direct relationship to ITI success in the international registry and a weaker inverse relationship in the North American registry. There is an international multicentre prospective randomized trial underway to further study the role of FVIII dose in successful ITI induction in a good risk haemophilia A inhibitor patient cohort. FVIII purity also remains an unproved ITI outcome predictor. Institutional experience with von-Willebrand-factor-containing products has suggested its therapeutic advantage in both inhibitor development and eradication. The International ITI Study, although not designed to answer this particular question, may be able to determine an impact on outcome depending on the final distribution of investigator choice of product among the study subjects. Much less is known about the influence of factor IX (FIX) dose and purity on ITI success in haemophilia B. Importantly, nephrotic syndrome has been a major determinant of ITI failure in FIX inhibitor patients, particularly those with the allergic phenotype. Unfortunately, large prospective randomized trials in this group will not be feasible. Rather, we will have to rely on prospectively collected registry data to build our knowledge base of inhibitors and ITI in haemophilia B.

PROSPECTIVE EVALUATION OF AN IN VITRO RADIATION RESISTANCE ASSAY IN LOCALLY ADVANCED CANCER OF THE UTERINE CERVIX: A SOUTHWEST ONCOLOGY GROUP STUDY

PubMed Central

Randall, Leslie M; Monk, Bradley J; Moon, James; Parker, Ricardo; Al-Ghazi, Muthana; Wilczynski, Sharon; Fruehauf, John P; Markman, Maurie; Burger, Robert A

2010-01-01

Objectives To investigate the feasibility of performing a fresh-tissue, in vitro radiation resistance assay (IVRRA) in a cooperative group setting and to assess the association of IVRRA results with clinical outcomes. Methods Women with Stages IIB-IVA carcinoma of the uterine cervix without obvious para-aortic lymphadenopathy on imaging were eligible. Primary tumor biopsies were shipped to a central testing facility where agar-based cell suspensions were exposed to 300 cGy of RT ± cisplatin and cultured for 5 days. 3H-thymidine incorporation was used to determine percent cell inhibition (PCI) of test specimen compared to that of the untreated control. Tumors were considered to exhibit extreme radiation resistance (ERR), intermediate radiation resistance (IRR) or low radiation resistance (LRR) based on a standard data set from 39 previously studied specimens. Standardized doses of external beam radiation and intracavitary brachytherapy, when feasible, in addition to platinum-based chemotherapy were mandated. Progression-free survival (PFS) was the primary endpoint. Clinical response and overall survival (OS) were secondary endpoints. Clinical investigators were blinded to assay data and vice versa. Results Thirty-six patients were enrolled, but analysis was limited to 17 patients whose specimens were adequate for IVRRA. The median follow-up time was 40 months. There was no association between IVRRA and response. In the Cox model, IRR/ERR tumors showed worse PFS [HR=11.2 (95% CI 1.3–96, p=0.03)] and worse OS [HR=11.7 (95% CI 1.4–99.6, p=0.03)] compared to LRR tumors when IVRRA was performed with RT alone, but there were no associations between IVRRA and PFS or OS when cisplatin was added to the IVRRA. Conclusions IVRRA (RT alone) results correlated with PFS and OS in this prospective trial, but follow-up trials are indicated to address feasibility and to confirm results in an expanded cohort. If confirmed, IVRRA could potentially direct molecular identification of novel targeted therapeutic approaches which might counteract radiation resistance. PMID:20846714

Feasibility of web-based self-triage by parents of children with influenza-like illness: a cautionary tale.

PubMed

Anhang Price, Rebecca; Fagbuyi, Daniel; Harris, Racine; Hanfling, Dan; Place, Frederick; Taylor, Todd B; Kellermann, Arthur L

2013-02-01

Self-triage using web-based decision support could be a useful way to encourage appropriate care-seeking behavior and reduce health system surge in epidemics. However, the feasibility and safety of this strategy have not previously been evaluated. To assess the usability and safety of Strategy for Off-site Rapid Triage (SORT) for Kids, a web-based decision support tool designed to translate clinical guidance developed by the Centers for Disease Control and Prevention to help parents and adult caregivers determine if a child with influenza-like illness requires immediate care in an emergency department (ED). Prospective pilot validation study conducted between February 8 and April 30, 2012. Staff who abstracted medical records and made follow-up calls were blinded to the SORT algorithm's assessment of the child's level of risk. Two pediatric emergency departments in the National Capital Region. Convenience sample of 294 parents and adult caregivers who were at least 18 years of age; able to read and speak English; and the parent or legal guardian of a child 18 years or younger presenting to 1 of 2 EDs with signs and symptoms meeting Centers for Disease Control and Prevention criteria for influenza-like illness. Completion of the SORT for Kids survey. Caregiver ratings of the website's usability and the sensitivity of the underlying algorithm for identifying children who required immediate ED management of influenza-like illness, defined as receipt of 1 or more of 5 essential clinical services. Ninety percent of participants reported that the website was "very easy" to understand and use. Ratings did not differ by respondent race, ethnicity, or educational attainment. Of the 15 patients whose initial ED visit met explicit criteria for clinical necessity, the Centers for Disease Control and Prevention algorithm classified 14 as high risk, resulting in an overall sensitivity of 93.3% (exact 95% CI, 68.1%-99.8%). Specificity of the algorithm was poor. This pilot study suggests that web-based decision support to help parents and adult caregivers self-triage children with influenza-like illness is feasible. However, prospective refinement of the clinical algorithm is needed to improve its specificity without compromising patient safety.

Feasibility of sedation and analgesia interruption following cannulation in neonates on extracorporeal membrane oxygenation

PubMed Central

Wildschut, E. D.; Hanekamp, M. N.; Vet, N. J.; Houmes, R. J.; Ahsman, M. J.; Mathot, R. A. A.; de Wildt, S. N.

2010-01-01

Purpose In most extracorporeal membrane oxygenation (ECMO) centers patients are heavily sedated to prevent accidental decannulation and bleeding complications. In ventilated adults not on ECMO, daily sedation interruption protocols improve short- and long-term outcome. This study aims to evaluate safety and feasibility of sedation interruption following cannulation in neonates on ECMO. Methods Prospective observational study in 20 neonates (0.17–5.8 days of age) admitted for ECMO treatment. Midazolam (n = 20) and morphine (n = 18) infusions were discontinued within 30 min after cannulation. Pain and sedation were regularly assessed using COMFORT-B and visual analog scale (VAS) scores. Midazolam and/or morphine were restarted and titrated according to protocolized treatment algorithms. Results Median (interquartile range, IQR) time without any sedatives was 10.3 h (5.0–24.1 h). Median interruption duration for midazolam was 16.5 h (6.6–29.6 h), and for morphine was 11.2 h (6.7–39.4 h). During this period no accidental extubations, decannulations or bleeding complications occurred. Conclusions This is the first study to show that interruption of sedatives and analgesics following cannulation in neonates on ECMO is safe and feasible. Interruption times are 2–3 times longer than reported for adult ICU patients not on ECMO. Further trials are needed to substantiate these findings and evaluate short- and long-term outcomes. PMID:20508914

High dose hypofractionated frameless volumetric modulated arc radiotherapy is a feasible method for treating canine trigeminal nerve sheath tumors.

PubMed

Dolera, Mario; Malfassi, Luca; Marcarini, Silvia; Mazza, Giovanni; Carrara, Nancy; Pavesi, Simone; Sala, Massimo; Finesso, Sara; Urso, Gaetano

2018-06-08

The aim of this prospective pilot study was to evaluate the feasibility and effectiveness of curative intent high dose hypofractionated frameless volumetric modulated arc radiotherapy for treatment of canine trigeminal peripheral nerve sheath tumors. Client-owned dogs with a presumptive imaging-based diagnosis of trigeminal peripheral nerve sheath tumor were recruited for the study during the period of February 2010 to December 2013. Seven dogs were enrolled and treated with high dose hypofractionated volumetric modulated arc radiotherapy delivered by a 6 MV linear accelerator equipped with a micro-multileaf beam collimator. The plans were computed using a Monte Carlo algorithm with a prescription dose of 37 Gy delivered in five fractions on alternate days. Overall survival was estimated using a Kaplan-Meier curve analysis. Magnetic resonance imaging (MRI) follow-up examinations revealed complete response in one dog, partial response in four dogs, and stable disease in two dogs. Median overall survival was 952 days with a 95% confidence interval of 543-1361 days. Volumetric modulated arc radiotherapy was demonstrated to be feasible and effective for trigeminal peripheral nerve sheath tumor treatment in this sample of dogs. The technique required few sedations and spared organs at risk. Even though larger studies are required, these preliminary results supported the use of high dose hypofractionated volumetric modulated arc radiotherapy as an alternative to other treatment modalities. © 2018 American College of Veterinary Radiology.

Exergaming for health: a community-based pediatric weight management program using active video gaming.

PubMed

Christison, Amy; Khan, Huma Ali

2012-04-01

To evaluate the efficacy and feasibility of a multifaceted, community-based weight intervention program for children using exergaming technology (activity-promoting video gaming). This is a prospective observational pilot study. Forty-eight children, between the ages of 8 and 16 years, who are overweight or obese, enrolled in Exergaming for Health, a multidisciplinary weight management program, which used active video gaming. Primary outcome measures were change in body mass index (BMI) z scores. Most children (n = 40, 83%) completed the program and participated in outcome evaluations. The average BMI change was -0.48 kg/m(2) (SD = 0.93), P < .002 (BMI z-score change was -0.072, SD = 0.14, P < .0001). The average Global Self-Worth score improved, screen time and soda intake reduced, and exercise hours per week increased. The Exergaming for Health program may be an effective weight management intervention that is feasible with high participation rates. A larger randomized controlled trial is needed to confirm these results.

Progress and prospects for field cultivation of Iridaea cordata and Gigartina exasperata

DOE Office of Scientific and Technical Information (OSTI.GOV)

Mumford, T.F. Jr.; Waaland, J.R.

1980-01-01

Research on cultivation of two carrageenan producing seaweeds, Iridaea cordatas and Gigartina exasperata, has resulted in 60 net units, each 1.2 x 18 m outplanted in the inland marine waters of Washington State. This paper traces the progress from beginning field and laboratory studies that demonstrated the biological feasibility of growing these species on artificial substrates, to current commercial sized net modules. The results achieved with these species are compared with other experimental, pilot, and commercial-scale red algal cultivation efforts. Methods are given here for inoculating nets and outplanting them in small, intermediate and commercial-scale net modules which can bemore » used to determine the feasibility of cultivating these or other species in various localities. A brief summary of supporting research which has been accomplished, which is in progress, and which needs to be done is also given. The outlook for expanded seaweed cultivation is promising and its potential great for providing new and expanded sources of chemicals, food, and biomass.« less

Optimizing tubal ligation service delivery: a prospective cohort study to measure the task-sharing experience of Marie Stopes International Ethiopia.

PubMed

Nuccio, Olivia; Sendek, Birhanu; Park, Min Hae; Mesele, Tesfaye; Okello, Francis Ogojo; Gordon-Maclean, Cristin

2017-03-01

The Ethiopian government implements a progressive task-sharing policy for health services as a strategy to address shortages of highly skilled providers and increase access to critical services, such as family planning. Since 2009, Marie Stopes International Ethiopia has trained health officers to provide tubal ligations, a permanent method of family planning, as part of its task-sharing strategy. The objectives of this research were to evaluate task-sharing tubal ligations to health officers at Marie Stopes International Ethiopia, specifically: (a) to investigate safety, as measured by the proportion of major adverse events; (b) to evaluate the feasibility, as measured by adherence to the standard tubal ligation procedure protocol and (c) to investigate acceptability to clients of the tubal ligation procedure provided by health officers. We established a prospective cohort of women aged  ≥18 years presenting for tubal ligation at Marie Stopes International Ethiopia sites in three regions in Ethiopia (March–May 2014). Data on adverse events (incomplete procedure, pain, bleeding, infection, perforation) were collected intra-operatively; peri-operatively (1-h post-procedure); and post-operatively (7 days post-procedure). To measure feasibility, 65% of procedures were selected for ‘audit’, where a nurse observed and scored health officers adherence to standard protocol using an 18-item checklist. To assess acceptability, women were asked about their satisfaction with the procedure. In total, 276 women were enrolled in the study. 97.5% of procedures took place in rural settings. All participants were followed up 7 days post-procedure (100% response rate). The overall proportion of major adverse events was 3% (95% CI 1–6%). The most frequent adverse event was ‘failure to complete the TL’ (2.2%, n = 6). The average score on protocol adherence was 96.9%. Overall, 98.2% (n = 271) of clients would recommend the procedure to a friend. Findings from this study, indicating safety, feasibility and acceptability, are consistent with the existing literature, which indicate safety and acceptability for task-sharing tubal ligations, and other methods of contraception with non-physician health providers. This study adds to scant literature on task-sharing tubal ligations in rural and low-resource settings.

Mindfulness-based Intervention for Female Adolescents with Chronic Pain: A Pilot Randomized Trial

PubMed Central

Chadi, Nicholas; McMahon, Audrey; Vadnais, Majorie; Malboeuf-Hurtubise, Catherine; Djemli, Anissa; Dobkin, Patricia L.; Lacroix, Jacques; Luu, Thuy Mai; Haley, Nancy

2016-01-01

Objective To test the feasibility of a randomized-controlled trial measuring the impact of an adapted mindfulness-based intervention (MBI) in female adolescents with chronic pain. Methods This was a single center, single-blind, prospective, experimental, longitudinal trial conducted in a pediatric tertiary care center. Participants had a history of chronic pain during at least three months. They were randomized into an intervention group or a wait-list control group. Both groups successively followed an adapted eight-week MBI designed specifically for adolescents with chronic pain. Pre-determined criteria were established to assess the feasibility, validity and acceptability of the study model. Data evaluating changes in quality of life, depression, anxiety, pain perception, psychological distress and salivary cortisol were collected throughout the 4-month study period. Results Nineteen female participants completed the study and had a mean age of 15.8 years (range 13.9 -17.8). Attrition rate was low (17%). Attendance to mindfulness sessions (84%) and compliance to study protocol (100%) were high. All participants reported a positive change in the way they coped with pain. No changes in quality of life, depression, anxiety, pain perception, and psychological distress were detected. Significant reductions in pre-and post-mindfulness session salivary cortisol levels were observed (p<0.001). Conclusions Mindfulness is a promising therapeutic approach for which limited data exist in adolescents with chronic pain. Our study indicates the feasibility of conducting such interventions in teenage girls. A large trial is needed to demonstrate the efficacy and bio-physiological impacts of MBIs in teenagers with chronic pain. PMID:27924146

The international Hip Outcome Tool-33 (iHOT-33): multicenter validation and translation to Spanish.

PubMed

Ruiz-Ibán, Miguel Angel; Seijas, Roberto; Sallent, Andrea; Ares, Oscar; Marín-Peña, Oliver; Muriel, Alfonso; Cuéllar, Ricardo

2015-05-20

The international Hip Outcome Tool-33 (iHOT-33) is a 33-item self administered outcome measure based on a Visual Analogue Scale response format designed for young and active population with hip pathology. The aim of the present study is to translate and validate the iHOT-33 into Spanish. 97 patients undergoing hip arthroscopy were included in this prospective and multicenter study performed between January 2012 and May 2014. Crosscultural adaptation was used to translate iHOT-33 into Spanish. Patients completed the questionnaire before and after surgery. Feasibility, reliability, internal consistency, construct validity (correlation with Western Ontario and McMaster Universities Osteoarthritis Index), ceiling and floor effects and sensitivity to change were assessed for the present study. Mean age was 48 years old. Feasibility: 41.2 % patients had no blank questions, and 71.3 % of patients had fulfilled all but one or two questions. Reliability: ICC for the global questionnaire was 0.97, showing that the questionnaire is highly reproducible. Internal consistency: Cronbach's alpha was 0.98 for the global questionnaire. Construct validity: there was a high correlation with WOMAC (correlation coefficient >0.5). The Ceiling effect (taking into account the minimum detectable change) was 12.1 % and the floor effect was 21.6 %, for the global questionnaire. Large sensitivity to change was shown. the Spanish version of iHOT-33 has shown to be feasible, reliable and sensible to changes for patients undergoing hip arthroscopy. This validated translation of iHOT-33 allows for comparisons between studies involving either Spanish- or English-speaking patients. Prognostic study, Level I.

Online self-administered training for post-traumatic stress disorder treatment providers: design and methods for a randomized, prospective intervention study

PubMed Central

2012-01-01

This paper presents the rationale and methods for a randomized controlled evaluation of web-based training in motivational interviewing, goal setting, and behavioral task assignment. Web-based training may be a practical and cost-effective way to address the need for large-scale mental health training in evidence-based practice; however, there is a dearth of well-controlled outcome studies of these approaches. For the current trial, 168 mental health providers treating post-traumatic stress disorder (PTSD) were assigned to web-based training plus supervision, web-based training, or training-as-usual (control). A novel standardized patient (SP) assessment was developed and implemented for objective measurement of changes in clinical skills, while on-line self-report measures were used for assessing changes in knowledge, perceived self-efficacy, and practice related to cognitive behavioral therapy (CBT) techniques. Eligible participants were all actively involved in mental health treatment of veterans with PTSD. Study methodology illustrates ways of developing training content, recruiting participants, and assessing knowledge, perceived self-efficacy, and competency-based outcomes, and demonstrates the feasibility of conducting prospective studies of training efficacy or effectiveness in large healthcare systems. PMID:22583520

An experimental study of potential residential and commercial applications of small-scale hybrid power systems

NASA Astrophysics Data System (ADS)

Acosta, Michael Anthony

The research presented in this thesis provides an understanding of small-scale hybrid power systems. Experiments were conducted to identify potential applications of renewable energy in residential and commercial applications in the Rio Grande Valley of Texas. Solar and wind energy converted into electric energy was stored in batteries and inverted to power common household and commercial appliances. Several small to medium size hybrid power systems were setup and utilized to conduct numerous tests to study renewable energy prospects and feasibility for various applications. The experimental results obtained indicate that carefully constructed solar power systems can provide people living in isolated communities with sufficient energy to consistently meet their basic power needs.

Participant acceptability of exercise in kidney disease (PACE-KD): a feasibility study protocol in renal transplant recipients.

PubMed

Bishop, Nicolette C; Billany, Roseanne; Smith, Alice C

2017-09-24

Cardiovascular disease (CVD) is a major cause of mortality in renal transplant recipients (RTRs). General population risk scores for CVD underestimate the risk in patients with chronic kidney disease (CKD) suggesting additional non-traditional factors. Renal transplant recipients also exhibit elevated inflammation and impaired immune function. Exercise has a positive impact on these factors in patients with CKD but there is a lack of rigorous research in RTRs, particularly surrounding the feasibility and acceptability of high-intensity interval training (HIIT) versus moderate-intensity continuous training (MICT) in this population. This study aims to explore the feasibility of three different supervised aerobic exercise programmes in RTRs to guide the design of future large-scale efficacy studies. Renal transplant recipients will be randomised to HIIT A (16 min interval training with 4, 2 and 1 min intervals at 80%-90% of peak oxygen uptake (VO 2 peak )), HIIT B (4×4 min interval training at 80%-90% VO 2peak ) or MICT (~40 min cycling at 50%-60% VO 2peak ) where they will undertake 24 supervised sessions (approximately thrice weekly over 8 weeks). Assessment visits will be at baseline, midtraining, immediate post-training and 3 months post-training. The study will evaluate the feasibility of recruitment, randomisation, retention, assessment procedures and the implementation of the interventions. A further qualitative sub-study QPACE-KD (Qualitative Participant Acceptability of Exercise in Kidney Disease) will explore patient experiences and perspectives through semistructured interviews and focus groups. All required ethical and regulatory approvals have been obtained. Findings will be disseminated through conference presentations, public platforms and academic publications. Prospectively registered; ISRCTN17122775. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Can we predict necrosis intra-operatively? Real-time optical quantitative perfusion imaging in surgery: study protocol for a prospective, observational, in vivo pilot study.

PubMed

Jansen, Sanne M; de Bruin, Daniel M; van Berge Henegouwen, Mark I; Strackee, Simon D; Veelo, Denise P; van Leeuwen, Ton G; Gisbertz, Suzanne S

2017-01-01

Compromised perfusion as a result of surgical intervention causes a reduction of oxygen and nutrients in tissue and therefore decreased tissue vitality. Quantitative imaging of tissue perfusion during reconstructive surgery, therefore, may reduce the incidence of complications. Non-invasive optical techniques allow real-time tissue imaging, with high resolution and high contrast. The objectives of this study are, first, to assess the feasibility and accuracy of optical coherence tomography (OCT), sidestream darkfield microscopy (SDF), laser speckle contrast imaging (LSCI), and fluorescence imaging (FI) for quantitative perfusion imaging and, second, to identify/search for criteria that enable risk prediction of necrosis during gastric tube and free flap reconstruction. This prospective, multicenter, observational in vivo pilot study will assess tissue perfusion using four optical technologies: OCT, SDF, LSCI, and FI in 40 patients: 20 patients who will undergo gastric tube reconstruction after esophagectomy and 20 patients who will undergo free flap surgery. Intra-operative images of gastric perfusion will be obtained directly after reconstruction at four perfusion areas. Feasibility of perfusion imaging will be analyzed per technique. Quantitative parameters directly related to perfusion will be scored per perfusion area, and differences between biologically good versus reduced perfusion will be tested statistically. Patient outcome will be correlated to images and perfusion parameters. Differences in perfusion parameters before and after a bolus of ephedrine will be tested for significance. This study will identify quantitative perfusion-related parameters for an objective assessment of tissue perfusion during surgery. This will likely allow early risk stratification of necrosis development, which will aid in achieving a reduction of complications in gastric tube reconstruction and free flap transplantation. Clinicaltrials.gov registration number NCT02902549. Dutch Central Committee on Research Involving Human Subjects registration number NL52377.018.15.

The use of the RenalGuard system in cardiac surgery with cardiopulmonary bypass: a first in man prospective, observational, feasibility pilot study

PubMed Central

Giri, Ramesh; Wrigley, Benmjamin; Hennessy, Anne-Marie; Nicholas, Johann; Nevill, Alan

2017-01-01

Objectives As proof of concept, this prospective, observational study assessed the feasibility and early clinical outcomes of performing on-pump cardiac surgery with the RenalGuard system. Background Acute kidney injury (AKI) is reported in up to 30% of patients undergoing cardiac surgery and is a recognised independent predictor of both morbidity and mortality. Forced diuresis with the RenalGuard system reduces the incidence of AKI during percutaneous coronary intervention procedures but its use in cardiac surgery has not been explored. Methods Ten consecutive patients who were at risk of developing AKI during cardiac surgery were selected. The RenalGuard system was used to facilitate forced diuresis using weight-adjusted intravenous furosemide while maintaining neutral fluid balance by matched intravenous fluid replacement. This regimen was initiated preoperatively in all patients and continued for 6–12 hours postoperatively. Serum creatinine, electrolytes and need for renal replacement were documented in all patients. Results The RenalGuard system functioned successfully in all patients and facilitated high perioperative urine outputs, even when patients were placed on cardiopulmonary bypass (CPB). There were no incidences of significant (A) electrolyte imbalance, (B) changes in haemoglobin levels or (C) pulmonary oedema. No patients developed AKI within 36 hours of surgery despite one patient developing cardiac tamponade 8 hours postoperatively and one patient developing paralytic ileus. One patient, however, was ‘electively’ haemofiltered on day 2 after developing acute right ventricular failure. The median intensive care stay was 1.5 (1, 5) days. Conclusion The RenalGuard system can be used successfully in patients undergoing cardiac surgery with CPB and may reduce the incidence of AKI in at-risk patients. Trial registration NCT02974946; Pre-results. PMID:29071091

The use of the RenalGuard system in cardiac surgery with cardiopulmonary bypass: a first in man prospective, observational, feasibility pilot study.

PubMed

Luckraz, Heyman; Giri, Ramesh; Wrigley, Benmjamin; Hennessy, Anne-Marie; Nicholas, Johann; Nevill, Alan

2017-01-01

As proof of concept, this prospective, observational study assessed the feasibility and early clinical outcomes of performing on-pump cardiac surgery with the RenalGuard system. Acute kidney injury (AKI) is reported in up to 30% of patients undergoing cardiac surgery and is a recognised independent predictor of both morbidity and mortality. Forced diuresis with the RenalGuard system reduces the incidence of AKI during percutaneous coronary intervention procedures but its use in cardiac surgery has not been explored. Ten consecutive patients who were at risk of developing AKI during cardiac surgery were selected. The RenalGuard system was used to facilitate forced diuresis using weight-adjusted intravenous furosemide while maintaining neutral fluid balance by matched intravenous fluid replacement. This regimen was initiated preoperatively in all patients and continued for 6-12 hours postoperatively. Serum creatinine, electrolytes and need for renal replacement were documented in all patients. The RenalGuard system functioned successfully in all patients and facilitated high perioperative urine outputs, even when patients were placed on cardiopulmonary bypass (CPB). There were no incidences of significant (A) electrolyte imbalance, (B) changes in haemoglobin levels or (C) pulmonary oedema. No patients developed AKI within 36 hours of surgery despite one patient developing cardiac tamponade 8 hours postoperatively and one patient developing paralytic ileus. One patient, however, was 'electively' haemofiltered on day 2 after developing acute right ventricular failure. The median intensive care stay was 1.5 (1, 5) days. The RenalGuard system can be used successfully in patients undergoing cardiac surgery with CPB and may reduce the incidence of AKI in at-risk patients. NCT02974946; Pre-results.

Percutaneous Radiofrequency Ablation of Painful Spinal Tumors Adjacent to the Spinal Cord with Real-Time Monitoring of Spinal Canal Temperature: A Prospective Study

DOE Office of Scientific and Technical Information (OSTI.GOV)

Nakatsuka, Atsuhiro, E-mail: nakatuka@clin.medic.mie-u.ac.jp; Yamakado, Koichiro; Takaki, Haruyuki

2009-01-15

PurposeTo prospectively evaluate the feasibility, safety, and clinical utility of bone radiofrequency (RF) ablation with real-time monitoring of the spinal canal temperature for the treatment of spinal tumors adjacent to the spinal cord.Materials and MethodsOur Institutional Review Board approved this study. Patients gave informed consent. The inclusion criteria were (a) a painful spinal metastasis and (b) a distance of 1 cm or less between the metastasis and the spinal cord. The thermocouple was placed in the spinal canal under CT fluoroscopic guidance. When the spinal canal temperature reached 45{sup o}C, RF application was immediately stopped. RF ablation was considered technicallymore » successful when the procedure was performed without major complications. Clinical success was defined as a fall in the visual analogue scale score of at least 2 points.ResultsTen patients with spinal tumors measuring 3-8 cm (mean, 4.9 {+-} 1.5 cm) were enrolled. The distance between the tumor and the spinal cord was 1-6 mm (mean, 2.4 {+-} 1.6 mm). All procedures were judged technically successful (100%). The spinal canal temperature did not exceed 45{sup o}C in 9 of the 10 patients (90%). In the remaining patient, the temperature rose to 48{sup o}C, resulting in transient neural damage, although RF application was immediately stopped when the temperature reached 45{sup o}C. Clinical success was achieved within 1 week in all patients (100%).ConclusionBone RF ablation with real-time monitoring of the spinal canal temperature is feasible, safe, and clinically useful for the treatment of painful spinal metastases adjacent to the spinal cord.« less

Effectiveness of Ambulatory Tru-Close Thoracic Vent for the Outpatient Management of Pneumothorax: A Prospective Pilot Study.

PubMed

Kim, Yong Pyo; Haam, Seok Jin; Lee, Sungsoo; Lee, Geun Dong; Joo, Seung-Moon; Yum, Tae Jun; Lee, Kwang-Hun

2017-01-01

This study aimed to assess the technical feasibility, procedural safety, and long-term therapeutic efficacy of a small-sized ambulatory thoracic vent (TV) device for the treatment of pneumothorax. From November 2012 to July 2013, 18 consecutive patients (3 females, 15 males) aged 16-64 years (mean: 34.7 ± 14.9 years, median: 29 years) were enrolled prospectively. Of these, 15 patients had spontaneous pneumothorax and 3 had iatrogenic pneumothorax. A Tru-Close TV with a small-bore (11- or 13-Fr) catheter was inserted under bi-plane fluoroscopic assistance. Technical success was achieved in all patients. Complete lung re-expansion was achieved at 24 hours in 88.9% of patients (16/18 patients). All patients tolerated the procedure and no major complications occurred. The patients' mean numeric pain intensity score was 2.4 (range: 0-5) in daily life activity during the TV treatment. All patients with spontaneous pneumothorax underwent outpatient follow-up. The mean time to TV removal was 4.7 (3-13) days. Early surgical conversion rate of 16.7% (3/18 patients) occurred in 2 patients with incomplete lung expansion and 1 patient with immediate pneumothorax recurrence post-TV removal; and late surgical conversion occurred in 2 of 18 patients (11.1%). The recurrence-free long-term success rate was 72.2% (13/18 patients) during a 3-year follow-up period from November 2012 to June 2016. TV application was a simple, safe, and technically feasible procedure in an outpatient clinic, with an acceptable long-term recurrence-free rate. Thus, TV could be useful for the immediate treatment of pneumothorax.

Helical-Tip Needle for Transthoracic Percutaneous Image-Guided Biopsy of Lung Tumors: Results of a Pilot Prospective Comparative Study with a Standard Tru-Cut Needle

DOE Office of Scientific and Technical Information (OSTI.GOV)

Veltri, Andrea, E-mail: andrea.veltri@unito.it; Busso, Marco; Sardo, Diego

PurposeTo prospectively evaluate feasibility and diagnostic performance of the 14-gauge helical-tip (Spirotome™, Cook{sup ®} Medical, Bloomington, USA) needle in transthoracic needle biopsy (TTNB) of lung lesions, compared to a conventional 18-gauge Tru-Cut needle.Materials and MethodsStudy was institutional review board approved, with informed consent obtained. Data from synchronous Spirotome and Tru-Cut image-guided TTNB of 20 consecutive patients with malignant peripheral lung tumors larger than 3 cm were enrolled for pathologic characterization and mutational analysis. Samples obtained with Spirotome and Tru-Cut needle were compared for fragmentation, length, weight, morphologic and immunohistochemistry typifying, tumor cellularity (TC) and DNA concentration.ResultsThe technical success rate for TTNBmore » with Spirotome was 100%, and no major complications occurred. Less fragmentation (mean 2 vs. 3 fragments, P = .418), greater weight (mean 13 vs. 8.5 mg, P = .027) and lower length (mean 10.2 vs. 12.6 mm, P = .174) were observed with Spirotome compared to Tru-Cut needle. Accuracy of Spirotome and Tru-Cut needle in defining cancer histotype was similar (90%). Absolute and relative TC (mean 42 vs. 38, 124 vs. 108/10HPF), and DNA concentration (mean 49.6 vs. 39.0 ng/μl) were higher with Spirotome compared to Tru-Cut needle, with no statistical significance (P = .787 and P = .140, respectively).Conclusions Percutaneous 14-gauge Spirotome TTNB of selected lesions is feasible and accurate. It provides adequate samples for diagnosis, comparable to 18-gauge Tru-Cut needle, with a higher amount of tumor tissue (weight, TC, DNA concentration) even in shorter samples.« less

[Robotic rectal resection in rectal cancer: short term results in a monocentric prospective study].

PubMed

Bianchi, P; Petz, W; Spinoglio, G; Belotti, D; Bertani, E; Zampino, M G; Crosta, C; Lazzari, R; Andreoni, B

2011-12-01

The aim of this study was to evaluate technical feasibility, oncological safety and short-term clinical results of robotic rectal resection for cancer. From January 2008 to July 2010, 46 patients (27 males and 19 females, median age 69 years, median BMI 24.6 kg/m2) with histologically-proven adenocarcinoma of medium and distal rectum were enrolled in a prospective database. Preoperative assessment was performed with colonoscopy with biopsies, thoraco-abdominal CT scan, pelvic MRI and endorectal-ultrasound (ERUS). In the case of locally advanced non metastatic disease (T3/4 or N1/2), patients received preoperative radiotherapy (45 Grays in 5 weeks) and chemotherapy (oral Capecitabine). The robotic system was a four-arms Da Vinci® (Intuitive Surgical, Sunnyvale, CA, USA); arms position is not modified during the entire surgical procedure. Twenty-five patients received a preoperative radio-chemotherapy. Surgical procedure was an abdomino-perineal amputation in nine patients and an anterior resection in the remaining 37, with temporary ileostomy in 16 cases and a laparoscopic mobilization of splenic flexure in 25. Median operative time was 251 minutes, median time of first bowel movements 1.7 days and median hospital stay 6.7 days. Major complications requiring reoperation verified in 2 patients, while overall complication rate is 15.2%. Median number of harvested lymph nodes per patient was 18; median distance of the tumour from distal resection margin was 2 cm; distance of the tumour from circumferential margin was superior to 1 mm in all of the patients. At a median follow up of 11 months, all patients are alive and disease-free. Robotic rectal resection is a feasible technique which can provide good oncological and short-term clinical results.

Haplo-identical transplantation for acquired severe aplastic anaemia in a multicentre prospective study.

PubMed

Xu, Lan-Ping; Wang, Shun-Qing; Wu, De-Pei; Wang, Jian-Min; Gao, Su-Jun; Jiang, Ming; Wang, Cun-Bang; Zhang, Xi; Liu, Qi-Fa; Xia, Ling-Hui; Wang, Xin; Huang, Xiao-Jun

2016-10-01

We conducted a prospective, multicentre study to confirm the feasibility of haplo-identical transplantation in treatment of severe aplastic anaemia (SAA) as salvage therapy, by analysing the outcomes of 101 patients who received haplo-identical transplantation between June 2012 and October 2015. All cases surviving for more than 28 d achieved donor myeloid engraftment. The median time for myeloid engraftment was 12 (range, 9-25) days and 15 (range, 7-101) days for platelets, with a cumulative platelet engraftment incidence of 94·1 ± 0·1%. With a median follow-up of 18·3 (3·0-43·6) months, recipients from haplo-identical transplantation had more cumulative incidence of grade II-IV acute graft-versus-host disease (aGVHD, 33·7% vs. 4·2%, P < 0·001), more chronic GVHD (22·4% vs. 6·6%, P = 0·014) at 1 year, but similar grade III-IV aGVHD (7·9% vs. 2·1%, P = 0·157), 3-year estimated overall survival (OS, 89·0% vs. 91·0%, P = 0·555) and failure-free survival (FFS, 86·8% vs. 80·3%, P = 0·659) when compared with 48 patients who received contemporaneous transplantation from matched related donors. Multivariate analysis showed no significant difference in engraftment and survival between the two cohorts. Both OS and FFS for the entire population correlated significantly with grades III-IV aGVHD. In conclusion, haplo-identical transplantation is a feasible choice for SAA with favourable outcomes. © 2016 John Wiley & Sons Ltd.

Prospective Study on Music Therapy in Terminally Ill Cancer Patients during Specialized Inpatient Palliative Care.

PubMed

Kordovan, Sarah; Preissler, Pia; Kamphausen, Anne; Bokemeyer, Carsten; Oechsle, Karin

2016-04-01

This study was a prospective evaluation of feasibility, acceptance, and potential beneficial effects of music therapy in terminally ill cancer patients on a specialized palliative care inpatient ward. Intervention had to consist of at least two sessions, but frequency and duration was left to the patients` decision. Different music therapy methods were offered to the patient at the beginning of every session. Patients rated their subjective benefit. Disease-related and sociodemographic factors were considered as potentially influencing factors. A total of 166 music therapy sessions were performed with 41 patients (average, 4; range, 2-10). Average session duration was 41 minutes (range, 20-70). Most favored methods were therapeutic conversation in 84% of sessions; listening to relaxing music, 39%; playing an instrument, 31%; and music-lead imagination, 11%. Receptive music therapy was applied in 45%, active forms in 25%, a combination of both in 7%, and therapeutic conversation only in 23%. Music therapy was rated to be "helpful" in 68%. Positive effects were significantly associated with frequency (p = 0.009) and duration (p = 0.040), living in a partnership (p = 0.017), having children (p = 0.035), psycho-oncologic therapy (p = 0.043), experience with music therapy (p = 0.007), role of music in life (p = 0.035), playing an instrument (p = 0.021), and singing regularly (p = 0.003). Music therapy techniques, especially receptive methods, are feasible and well accepted in terminally ill cancer patients. Therapeutic conversation seems to play an important role. Frequency and duration of music therapy, previous experience with music and music therapy, as well as sociodemographic factors influence positive effects of music therapy.

Satellite Power System (SPS): an Overview of Prospective Organizational Structures in the Solar Satellite Field

NASA Technical Reports Server (NTRS)

Edler, H. G.

1978-01-01

A literature survey, interviews with acknowledged experts in the fields of organizational entities, space, solar energy, and the SPS concept, and an analysis of these inputs to identify the organizational alternatives and make judgments as to their feasibility to serve as patterns for a future SPS entity are presented. Selection and evaluation criteria were determined to include timeliness, reliability, and adequacy to contribute meaningfully to the U.S. supply; political feasibility (both national and international) and cost-effectiveness (including environmental and other external costs). Based on these criteria, four organizational alternatives are discussed which offer reasonable promise as potential options for SPS. These included three domestic alternatives and one international alternative.

Laparoscopic versus open total mesorectal excision: a case-control study.

PubMed

Breukink, S O; Pierie, J P E N; Grond, A J K; Hoff, C; Wiggers, T; Meijerink, W J H J

2005-09-01

Because definitive long-term results are not yet available, the oncological safety of laparoscopic surgery for treatment of rectal cancer remains unproven. The aim of this prospective non-randomised study was to assess the feasibility and short-term outcome of laparoscopic total mesorectal excision (LTME) after 25--30 Gy preoperative radiotherapy and to compare the results with a matched-control group of open TME (OTME). A series of 41 patients with primary rectal cancer underwent LTME for rectal cancer and were matched with a historical control group of 41 patients who underwent OTME. Both groups received preoperative short-term radiotherapy. There was no mortality in the LTME group and 2% mortality in the OTME group. The overall postoperative morbidity was 37% in the LTME group and 51% in the OTME group, including an anastomotic leakage of 9 and 14% in the LTME and OTME groups respectively. A positive circumferential margin was found in 7% of patients in the LTME group and in 12% of the patients in the OTME group. This study shows that LTME is technically feasible and can be performed safely. We show at least a similar surgical completeness using a laparoscopic technique compared with open surgery.

Balneotherapy Together with a Psychoeducation Program for Benzodiazepine Withdrawal: A Feasibility Study

PubMed Central

De Maricourt, P.; Hergueta, Th.; Galinowski, A.; Salamon, R.; Diallo, A.; Vaugeois, C.; Lépine, J. P.; Olié, J. P.

2016-01-01

Benzodiazepines should be prescribed on a short-term basis, but a significant proportion of patients (%) use them for more than 6 months, constituting a serious public health issue. Indeed, few strategies are effective in helping patients to discontinue long-term benzodiazepine treatments. The aim of this study was to assess the feasibility and the impact of a program including cognitive behavioural therapy, psychoeducation, and balneotherapy in a spa resort to facilitate long-term discontinuation of benzodiazepines. We conducted a prospective multicentre cohort study. Patients with long-term benzodiazepine use were recruited with the aim of anxiolytic withdrawal by means of a psychoeducational program and daily balneotherapy during 3 weeks. The primary efficacy outcome measure was benzodiazepine use 6 months after the program, compared to use at baseline. A total of 70 subjects were enrolled. At 6 months, overall benzodiazepine intake had decreased by 75.3%, with 41.4% of patients completely stopping benzodiazepine use. The results also suggest a significantly greater improvement in anxiety and depression symptoms among patients who discontinued benzodiazepines compared to patients who only reduced their use. Our findings suggest that balneotherapy in association with a psychoeducative program is efficient in subjects with benzodiazepine addiction. PMID:27956923

Feasibility of rapid and automated importation of 3D echocardiographic left ventricular (LV) geometry into a finite element (FEM) analysis model

PubMed Central

Verhey, Janko F; Nathan, Nadia S

2004-01-01

Background Finite element method (FEM) analysis for intraoperative modeling of the left ventricle (LV) is presently not possible. Since 3D structural data of the LV is now obtainable using standard transesophageal echocardiography (TEE) devices intraoperatively, the present study describes a method to transfer this data into a commercially available FEM analysis system: ABAQUS©. Methods In this prospective study TomTec LV Analysis TEE© Software was used for semi-automatic endocardial border detection, reconstruction, and volume-rendering of the clinical 3D echocardiographic data. A newly developed software program MVCP FemCoGen©, written in Delphi, reformats the TomTec file structures in five patients for use in ABAQUS and allows visualization of regional deformation of the LV. Results This study demonstrates that a fully automated importation of 3D TEE data into FEM modeling is feasible and can be efficiently accomplished in the operating room. Conclusion For complete intraoperative 3D LV finite element analysis, three input elements are necessary: 1. time-gaited, reality-based structural information, 2. continuous LV pressure and 3. instantaneous tissue elastance. The first of these elements is now available using the methods presented herein. PMID:15473901

Evaluation of the implementation of a quality system in a basic research laboratory: viability and impacts.

PubMed

Fraga, Hilda Carolina de Jesus Rios; Fukutani, Kiyoshi Ferreira; Celes, Fabiana Santana; Barral, Aldina Maria Prado; Oliveira, Camila Indiani de

2012-01-01

To evaluate the process of implementing a quality management system in a basic research laboratory of a public institution, particularly considering the feasibility and impacts of this improvement. This was a prospective and qualitative study. We employed the norm "NIT DICLA 035--Princípios das Boas Práticas de Laboratório (BPL)" and auxiliary documents of Organisation for Economic Co-operation and Development to complement the planning and implementation of a Quality System, in a basic research laboratory. In parallel, we used the PDCA tool to define the goals of each phase of the implementation process. This study enabled the laboratory to comply with the NIT DICLA 035 norm and to implement this norm during execution of a research study. Accordingly, documents were prepared and routines were established such as the registration of non-conformities, traceability of research data and equipment calibration. The implementation of a quality system, the setting of a laboratory focused on basic research is feasible once certain structural changes are made. Importantly, impacts were noticed during the process, which could be related to several improvements in the laboratory routine.

Electronic Adherence Monitoring in a High-Utilizing Pediatric Asthma Cohort: A Feasibility Study.

PubMed

Kenyon, Chén Collin; Chang, Joyce; Wynter, Sheri-Ann; Fowler, Jessica C; Long, Jin; Bryant-Stephens, Tyra C

2016-06-22

Inner-city, minority children with asthma have the highest rates of morbidity and death from asthma and the lowest rates of asthma controller medication adherence. Some recent electronic medication monitoring interventions demonstrated dramatic improvements in adherence in lower-risk populations. The feasibility and acceptability of such an intervention in the highest-risk children with asthma has not been studied. Our objective was to assess the feasibility and acceptability of a community health worker-delivered electronic adherence monitoring intervention among the highest utilizers of acute asthma care in an inner-city practice. This was a prospective cohort pilot study targeting children with the highest frequency of asthma-related emergency department and hospital care within a local managed care Medicaid plan. The 3-month intervention included motivational interviewing, electronic monitoring of controller and rescue inhaler use, and outreach by a community health worker for predefined medication alerts. We measured acceptability by using a modified technology acceptability model and changes in asthma control using the Asthma Control Test (ACT). Given prominent feasibility issues, we describe qualitative patterns of medication use at baseline only. We enrolled 14 non-Hispanic black children with a median age of 3.5 years. Participants averaged 7.8 emergency or hospital visits in the year preceding enrollment. We observed three distinct patterns of baseline controller use: 4 patients demonstrated sustained use, 5 patients had periodic use, and 5 patients lapsed within 2 weeks. All participants initiated use of the electronic devices; however, no modem signal was transmitted for 5 or the 14 participants after a mean of 45 days. Of the 9 (64% of total) caregivers who completed the final study visit, all viewed the electronic monitoring device favorably and would recommend it to friends, and 5 (56%) believed that the device helped to improve asthma control. ACT scores improved by a mean of 2.7 points (P=.05) over the 3-month intervention. High-utilizer, minority families who completed a community health worker-delivered electronic adherence intervention found it generally acceptable. Prominent feasibility concerns, however, such as recruitment, data transmission failure, and lost devices, should be carefully considered when designing interventions in this setting.

CT colonography with reduced bowel preparation after incomplete colonoscopy in the elderly.

PubMed

Iafrate, F; Hassan, C; Zullo, A; Stagnitti, A; Ferrari, R; Spagnuolo, A; Laghi, A

2008-07-01

We prospectively assessed the feasibility and acceptance of computerized tomographic colonography (CTC) without bowel cathartic preparation in elderly patients after incomplete colonoscopy. A total of 136 patients underwent CTC without cathartic preparation. The time delay between conventional colonoscopy and CTC ranged between 3 and 20 days, depending on the clinical situation. Before CTC, fecal tagging was achieved by adding diatrizoate meglumine and diatrizoate sodium to regular meals. CTCs were interpreted using a primary two-dimensional (2D) approach and 3D images for further characterization. Patients were interviewed before and 2 weeks after CTC to assess preparation acceptance. CTC was feasible and technically successful in all the 136 patients. Fecal tagging was judged as excellent in 113 (83%) patients and sufficient in 23 (17%). Average CT image interpretation time was 14.8 min. Six (4.4%) cases of colorectal cancer and nine (6.6%) large polyps were detected, as well as 23 (11.3%) extracolonic findings of high clinical importance. No major side effect occurred, although 25% patients reported minor side effects, especially diarrhea. Overall, 76/98 patients replied that they would be willing to repeat the test if necessary. CTC without cathartic preparation is a technically feasible and safe procedure to complete a colonic study in the elderly, prompting its use in clinical practice.

A nurse-run clinic for patients with incidentally discovered small abdominal aortic aneurysms is feasible and cost-effective.

PubMed

Griffin, J L; Clarke, G A; Roake, J A; Lewis, D R

2015-04-01

Patients with incidentally discovered small abdominal aortic aneurysms (AAA) require assessment by a vascular surgery department for possible enrollment in a surveillance programme. Our unit implemented a vascular nurse-run AAA clinic in October 2010. The aim of this study was to assess the feasibility of a specialist nurse-run small AAA clinic. Demographic and clinical data were collected prospectively for all patients seen in the new vascular nurse clinic between October 2010 and November 2012. A validated AAA operative mortality score was used to aid decision making by the vascular nurse. Some 250 patients were seen in the clinic. 198 (79.2%) patients were enrolled in surveillance, 40 (16%) declined enrollment and 12 (4.8%) were referred to a consultant clinic for further assessment. The majority of patients were male and the mean age was 73.7 years. Co-morbidities included hypertension, a history of cardiovascular disease, and hyperlipidaemia. The majority of referrals were considered to be low operative risk. No aneurysms ruptured whilst under surveillance. A nurse-run clinic that assesses patients with incidentally discovered small AAAs for inclusion in AAA surveillance is a feasible alternative to assessment of these patients in a consultant-run clinic. © The Author(s) 2014 Reprints and permissions: sagepub.co.uk/journalsPermissions.nav.

Acute pancreatitis patient registry to examine novel therapies in clinical experience (APPRENTICE): an international, multicenter consortium for the study of acute pancreatitis

PubMed Central

Papachristou, Georgios I.; Machicado, Jorge D.; Stevens, Tyler; Goenka, Mahesh Kumar; Ferreira, Miguel; Gutierrez, Silvia C.; Singh, Vikesh K.; Kamal, Ayesha; Gonzalez-Gonzalez, Jose A.; Pelaez-Luna, Mario; Gulla, Aiste; Zarnescu, Narcis O.; Triantafyllou, Konstantinos; Barbu, Sorin T.; Easler, Jeffrey; Ocampo, Carlos; Capurso, Gabriele; Archibugi, Livia; Cote, Gregory A.; Lambiase, Louis; Kochhar, Rakesh; Chua, Tiffany; Tiwari, Subhash Ch.; Nawaz, Haq; Park, Walter G.; de-Madaria, Enrique; Lee, Peter J.; Wu, Bechien U.; Greer, Phil J.; Dugum, Mohannad; Koutroumpakis, Efstratios; Akshintala, Venkata; Gougol, Amir

2017-01-01

Background We have established a multicenter international consortium to better understand the natural history of acute pancreatitis (AP) worldwide and to develop a platform for future randomized clinical trials. Methods The AP patient registry to examine novel therapies in clinical experience (APPRENTICE) was formed in July 2014. Detailed web-based questionnaires were then developed to prospectively capture information on demographics, etiology, pancreatitis history, comorbidities, risk factors, severity biomarkers, severity indices, health-care utilization, management strategies, and outcomes of AP patients. Results Between November 2015 and September 2016, a total of 20 sites (8 in the United States, 5 in Europe, 3 in South America, 2 in Mexico and 2 in India) prospectively enrolled 509 AP patients. All data were entered into the REDCap (Research Electronic Data Capture) database by participating centers and systematically reviewed by the coordinating site (University of Pittsburgh). The approaches and methodology are described in detail, along with an interim report on the demographic results. Conclusion APPRENTICE, an international collaboration of tertiary AP centers throughout the world, has demonstrated the feasibility of building a large, prospective, multicenter patient registry to study AP. Analysis of the collected data may provide a greater understanding of AP and APPRENTICE will serve as a future platform for randomized clinical trials. PMID:28042246

Longevity of metal-ceramic crowns cemented with self-adhesive resin cement: a prospective clinical study

PubMed

Brondani, Lucas Pradebon; Pereira-Cenci, Tatiana; Wandsher, Vinicius Felipe; Pereira, Gabriel Kalil; Valandro, Luis Felipe; Bergoli, César Dalmolin

2017-04-10

Resin cements are often used for single crown cementation due to their physical properties. Self-adhesive resin cements gained widespread due to their simplified technique compared to regular resin cement. However, there is lacking clinical evidence about the long-term behavior of this material. The aim of this prospective clinical trial was to assess the survival rates of metal-ceramic crowns cemented with self-adhesive resin cement up to six years. One hundred and twenty-nine subjects received 152 metal-ceramic crowns. The cementation procedures were standardized and performed by previously trained operators. The crowns were assessed as to primary outcome (debonding) and FDI criteria. Statistical analysis was performed using Kaplan-Meier statistics and descriptive analysis. Three failures occurred (debonding), resulting in a 97.6% survival rate. FDI criteria assessment resulted in scores 1 and 2 (acceptable clinical evaluation) for all surviving crowns. The use of self-adhesive resin cement is a feasible alternative for metal-ceramic crowns cementation, achieving high and adequate survival rates.

Neutron therapy of resistant thyroid gland cancer

NASA Astrophysics Data System (ADS)

Choynzonov, E. L.; Gribova, O. V.; Startseva, Zh. A.; Lisin, V. A.; Novikov, V. A.; Musabaeva, L. I.

2017-09-01

The purpose of this study was to analyze the results of the combined modality treatment and radiation therapy using 6.3 MeV fast neutrons c. The study included 45 patients with thyroid gland cancers who received the combined modality treatment and radiation therapy alone with the use of 6.3 MeV fast neutrons generated within U-120 cyclotron. The clinical trial of neutron-photon therapy used alone and in combination with the surgery for the patients with aggressive forms of thyroid cancer showed feasibility of increasing the effectiveness of treatment due to the reduction in the incidence of local recurrences. In addition, satisfactory treatment tolerance and absence of severe specific complications dictate the necessity of prospective studies to improve treatment outcomes.

Feasibility of a Telehealth Educational Program on Self-Management of Pain and Fatigue in Adult Cancer Patients.

PubMed

Rocque, Gabrielle B; Halilova, Karina I; Varley, Allyson L; Williams, Courtney P; Taylor, Richard A; Masom, David G; Wright, William J; Partridge, Edward E; Kvale, Elizabeth A

2017-06-01

Pain and fatigue are common symptoms among cancer patients and often lead to substantial distress. Innovative self-management programs for pain and fatigue are needed. The primary objective was to assess the feasibility of a telehealth pain and fatigue self-management program among adult cancer patients. Secondary objectives included assessment of differences in patient characteristics, recruitment, and retention of patients based on two screening strategies: 1) navigator-collected, patient-reported pain or fatigue and 2) in-clinic, physician-identified pain or fatigue. This prospective, nonrandomized, pre-post evaluation assessed feasibility, which was defined as 50% of eligible patients choosing to participate and completing the intervention. Patient demographics and patient-reported outcomes (patient activation, distress, symptoms, and quality of life) were collected at baseline and study completion. Differences in baseline characteristics were compared between cohorts and for patients who did vs. did not graduate from the program. The program did not meet feasibility requirements because of only 34% of eligible patients choosing to participate. However, 50% of patients starting the program graduated. Differences in baseline characteristics and retention rates were noted by recruitment strategy. At baseline, 27.3% of navigated patients were at the highest activation level compared with 7.1% in the physician-referred, non-navigated patients (P = 0.17); more than 15% of non-completers were at the lowest activation level compared with 9% of completers (P = 0.85). Telehealth self-management program for pain and fatigue may be better accepted among selected segments of cancer patients. Larger scale studies are needed to assess the efficacy of this program in a more selective activated population. Copyright © 2017 American Academy of Hospice and Palliative Medicine. Published by Elsevier Inc. All rights reserved.

Clinical feasibility of simultaneous multi-slice imaging with blipped-CAIPI for diffusion-weighted imaging and diffusion-tensor imaging of the brain.

PubMed

Yokota, Hajime; Sakai, Koji; Tazoe, Jun; Goto, Mariko; Imai, Hiroshi; Teramukai, Satoshi; Yamada, Kei

2017-12-01

Background Simultaneous multi-slice (SMS) imaging is starting to be used in clinical situation, although evidence of clinical feasibility is scanty. Purpose To prospectively assess the clinical feasibility of SMS diffusion-weighted imaging (DWI) and diffusion-tensor imaging (DTI) with blipped-controlled aliasing in parallel imaging for brain lesions. Material and Methods The institutional review board approved this study. This study included 156 hyperintense lesions on DWI from 32 patients. A slice acceleration factor of 2 was applied for SMS scans, which allowed shortening of the scan time by 41.3%. The signal-to-noise ratio (SNR) was calculated for brain tissue of a selected slice. The contrast-to-noise ratio (CNR), apparent diffusion coefficient (ADC), and fractional anisotropy (FA) were calculated in 36 hyperintense lesions with a diameter of three pixels or more. Visual assessment was performed for all 156 lesions. Tractography of the corticospinal tract of 29 patients was evaluated. The number of tracts and averaged tract length were used for quantitative analysis, and visual assessment was evaluated by grading. Results The SMS scan showed no bias and acceptable 95% limits of agreement compared to conventional scans in SNR, CNR, and ADC on Bland-Altman analyses. Only FA of the lesions was higher in the SMS scan by 9% ( P = 0.016), whereas FA of the surrounding tissues was similar. Quantitative analysis of tractography showed similar values. Visual assessment of DWI hyperintense lesions and tractography also resulted in comparable evaluation. Conclusion SMS imaging was clinically feasible for imaging quality and quantitative values compared with conventional DWI and DTI.

Measuring decision quality: psychometric evaluation of a new instrument for breast cancer surgery

PubMed Central

2012-01-01

Background The purpose of this paper is to examine the acceptability, feasibility, reliability and validity of a new decision quality instrument that assesses the extent to which patients are informed and receive treatments that match their goals. Methods Cross-sectional mail survey of recent breast cancer survivors, providers and healthy controls and a retest survey of survivors. The decision quality instrument includes knowledge questions and a set of goals, and results in two scores: a breast cancer surgery knowledge score and a concordance score, which reflects the percentage of patients who received treatments that match their goals. Hypotheses related to acceptability, feasibility, discriminant validity, content validity, predictive validity and retest reliability of the survey instrument were examined. Results We had responses from 440 eligible patients, 88 providers and 35 healthy controls. The decision quality instrument was feasible to implement in this study, with low missing data. The knowledge score had good retest reliability (intraclass correlation coefficient = 0.70) and discriminated between providers and patients (mean difference 35%, p < 0.001). The majority of providers felt that the knowledge items covered content that was essential for the decision. Five of the 6 treatment goals met targets for content validity. The five goals had moderate to strong retest reliability (0.64 to 0.87). The concordance score was 89%, indicating that a majority had treatments concordant with that predicted by their goals. Patients who had concordant treatment had similar levels of confidence and regret as those who did not. Conclusions The decision quality instrument met the criteria of feasibility, reliability, discriminant and content validity in this sample. Additional research to examine performance of the instrument in prospective studies and more diverse populations is needed. PMID:22681763

Ultrasound-Guided Radiofrequency Ablation Using a New Electrode with an Electromagnetic Position Sensor for Hepatic Tumors Difficult to Place an Electrode: A Preliminary Clinical Study.

PubMed

Kang, Tae Wook; Lee, Min Woo; Song, Kyoung Doo; Rhim, Hyunchul; Lim, Hyo Keun; Kang, Wonseok; Kim, Kyunga

2017-12-01

To evaluate whether a new electrode embedded with an electromagnetic position sensor (EMPS) improves the technical feasibility of percutaneous radiofrequency ablation (RFA) in patients with hepatic tumors difficult to place an electrode under ultrasonography (US) guidance and to assess short-term therapeutic efficacy and safety. This prospective study was approved by the institutional review board, and written informed consent was obtained from all patients. Between January 2015 and December 2016, 10 patients (7 men and 3 women; age range 52-75 years) with a single hepatic tumor (median 1.4 cm; range 1.1-1.8 cm) difficult to place an electrode under US guidance were enrolled. The technical feasibility of targeting and overlapping ablation during the RFA procedure was graded using a four-point scale and analyzed using the Wilcoxon signed rank test according to the use of EMPS. In addition, the rates of technical success, local tumor progression (LTP), and major complications were assessed. The use of the new RF electrode with EMPS significantly improved the technical feasibility of targeting and overlapping ablation (p = 0.002 and p = 0.003, respectively). After treatment, the technical success rate was 100%. LTP was not found in any patient during the follow-up period (median 8 months; range 4-22 months). No major procedure-related complications occurred. The technical feasibility of percutaneous RFA improves with the use of this RF electrode embedded with an EMPS. Short-term therapeutic efficacy and safety after RFA using the electrode were promising in patients with hepatic tumors difficult to place an electrode under US guidance.

Family physician-led, team-based, lifestyle intervention in patients with metabolic syndrome: results of a multicentre feasibility project

PubMed Central

Jeejeebhoy, Khursheed; Dhaliwal, Rupinder; Heyland, Daren K.; Leung, Roger; Day, Andrew G.; Brauer, Paula; Royall, Dawna; Tremblay, Angelo; Mutch, David M.; Pliamm, Lew; Rhéaume, Caroline; Klein, Doug

2017-01-01

Background: Metabolic syndrome (MetS) is a medical condition with major complications and health care costs. Previous research has shown that diet and exercise can improve and reverse this condition. The goal of this study was to test the feasibility and effectiveness of implementing the Canadian Health Advanced by Nutrition and Graded Exercise (CHANGE) program into diverse family medicine practices to improve MetS. Methods: In this longitudinal before-after study, 305 adult patients with MetS were recruited from 3 diverse family medicine team-based organizations to the CHANGE personalized diet and exercise program. Participants were followed for 12 months. Primary outcomes included feasibility and reversal of MetS. Secondary outcomes included improvement in MetS components, changes in diet quality, aerobic fitness and cardiovascular risk. Results: Participants attended 76% and 90% of the kinesiologist and dietitian visits, respectively. At 12 months, 19% of patients (95% confidence interval [CI] 14%-24%) showed reversal of MetS, VO2max increased by 16% (95% CI 13%-18%), and Healthy Eating Index and Mediterranean Diet Scores improved by 9.6% (95% CI 7.6%-11.6%) and 1.4% (1.1%-1.6%), respectively. In addition, the Prospective Cardiovascular Munster (PROCAM) 10-year risk of acute coronary event decreased by 1.4%, from a baseline of 8.6%. Interpretation: A team-based program led by the family physician that educates patients about the risks of MetS, and with a dietitian and kinesiologist, empowers them to undertake an individualized supervised program of diet modification and exercise, is feasible, improves aerobic capacity and diet quality, reverses MetS and improves MetS components at 12 months. PMID:28401139

Family physician-led, team-based, lifestyle intervention in patients with metabolic syndrome: results of a multicentre feasibility project.

PubMed

Jeejeebhoy, Khursheed; Dhaliwal, Rupinder; Heyland, Daren K; Leung, Roger; Day, Andrew G; Brauer, Paula; Royall, Dawna; Tremblay, Angelo; Mutch, David M; Pliamm, Lew; Rhéaume, Caroline; Klein, Doug

2017-01-01

Metabolic syndrome (MetS) is a medical condition with major complications and health care costs. Previous research has shown that diet and exercise can improve and reverse this condition. The goal of this study was to test the feasibility and effectiveness of implementing the Canadian Health Advanced by Nutrition and Graded Exercise (CHANGE) program into diverse family medicine practices to improve MetS. In this longitudinal before-after study, 305 adult patients with MetS were recruited from 3 diverse family medicine team-based organizations to the CHANGE personalized diet and exercise program. Participants were followed for 12 months. Primary outcomes included feasibility and reversal of MetS. Secondary outcomes included improvement in MetS components, changes in diet quality, aerobic fitness and cardiovascular risk. Participants attended 76% and 90% of the kinesiologist and dietitian visits, respectively. At 12 months, 19% of patients (95% confidence interval [CI] 14%-24%) showed reversal of MetS, VO2max increased by 16% (95% CI 13%-18%), and Healthy Eating Index and Mediterranean Diet Scores improved by 9.6% (95% CI 7.6%-11.6%) and 1.4% (1.1%-1.6%), respectively. In addition, the Prospective Cardiovascular Munster (PROCAM) 10-year risk of acute coronary event decreased by 1.4%, from a baseline of 8.6%. A team-based program led by the family physician that educates patients about the risks of MetS, and with a dietitian and kinesiologist, empowers them to undertake an individualized supervised program of diet modification and exercise, is feasible, improves aerobic capacity and diet quality, reverses MetS and improves MetS components at 12 months.

Robot-assisted task-oriented upper extremity skill training in cervical spinal cord injury: a feasibility study.

PubMed

Vanmulken, D A M M; Spooren, A I F; Bongers, H M H; Seelen, H A M

2015-07-01

Prospective multiple case study. To test (1) the feasibility of haptic robot technology (Haptic Master (HM)) use to improve arm-hand function (AHF) and arm-hand skill performance (AHSP) in persons with a cervical spinal cord injury (C-SCI), (2) inventory participants' motivation and expectation to work with the robot technology used and (3) to descriptively report the results in individual cases. Rehabilitation Centre. Five C-SCI patients were trained for 6 weeks, 3 days per week, 60 min per day. Therapists filled out the Usefulness, Satisfaction and Ease-of-use questionnaire (USE). The Intrinsic Motivational Inventory (IMI) and credibility and expectancy questionnaire (CEQ) were filled out by participants. Performance at activity level was gauged using the Van Lieshout test for AHF in Tetraplegia and the Spinal Cord Independence Measure. Function level was gauged using muscle strength testing and the International Classification for Surgery of the Hand in Tetraplegia. As to the feasibility of the application of haptic robot technology, the mean USE score was 65%. Mean IMI and CEQ results were 67% and 60%, respectively. Participants were motivated to train with the HM. All participants rated credibility higher than expectations regarding the improvement. In the current patients, little progress was demonstrated at the International Classification of Functioning, Disability and Health function and the activity level. It is feasible to train C-SCI persons with the HM. Therapists report that working with the HM is easy to learn and easy to perform. Usability of the HM may be improved. Further research is needed to assess in which group of C-SCI and at which stage of rehabilitation HM training may be most beneficial.

Liver transection using vascular stapler: a review

PubMed Central

Bruns, Helge; Weitz, Jürgen; Schmidt, Jan; Büchler, Markus W.

2008-01-01

The clinical experience using a novel technique of liver resection with vascular staplers for dissection of hepatic parenchyma, was documented most recently in a prospective manner. These data have clearly demonstrated for the first time that stapler hepatectomy is a safe and fast dissection technique in major liver surgery (e.g. hepatectomy) which is feasible in a routine clinical setting. PMID:18773103

Spatially explicit power analysis for occupancy-based monitoring of wolverine populations in the U.S

Treesearch

Martha M. Ellis; Jacob S. Ivan; Michael K. Schwartz

2014-01-01

Conservation scientists and resource managers often have to design monitoring programs for species that are rare or patchily distributed across large landscapes. Such programs are frequently expensive and seldom can be conducted by one entity. It is essential that a prospective power analysis be undertaken to ensure stated monitoring goals are feasible. We developed a...

A novel technique using high energy synchronous double-wave laser in endoscopic submucosal dissection of patients with superficial esophageal neoplasm.

PubMed

Yao, Jun; Li, Jun; Wang, Peng; Liu, Feng; Li, Zhaoshen

2018-06-08

BACKGROUND : Endoscopic submucosal dissection (ESD) has been widely used to treat superficial esophageal neoplasms (SENs). Intraoperative bleeding is one of the main concerns that makes ESD in the esophagus more difficult and time consuming with higher complication rates. We introduced a novel laser endoknife system that enabled better intraoperative hemostasis, and preliminarily investigated its feasibility in ESD for patients with SENs.  17 consecutive patients with SENs were prospectively enrolled. The laser endoknife system was used in marking and submucosal dissection. Data on therapeutic outcomes were collected and analyzed.  The median diameter of the lesions was 2.5 cm and of the resected specimens was 3.0 cm. The median procedure time was 48 minutes. Histologic evaluation revealed 15 high grade intraepithelial neoplasias and two squamous cell carcinomas. No intraoperative bleeding occurred during laser cutting and no significant complications occurred postoperatively. Curative R0 resection was achieved in all patients.  Our new laser endoknife system was feasible in the submucosal dissection of SENs and showed great prospects for future application. © Georg Thieme Verlag KG Stuttgart · New York.

Preoperative Modified FOLFIRINOX Treatment Followed by Capecitabine-Based Chemoradiation for Borderline Resectable Pancreatic Cancer

PubMed Central

Katz, Matthew H. G.; Shi, Qian; Ahmad, Syed A.; Herman, Joseph M.; Marsh, Robert de W.; Collisson, Eric; Schwartz, Lawrence; Frankel, Wendy; Martin, Robert; Conway, William; Truty, Mark; Kindler, Hedy; Lowy, Andrew M.; Bekaii-Saab, Tanios; Philip, Philip; Talamonti, Mark; Cardin, Dana; LoConte, Noelle; Shen, Perry; Hoffman, John P.; Venook, Alan P.

2016-01-01

IMPORTANCE Although consensus statements support the preoperative treatment of borderline resectable pancreatic cancer, no prospective, quality-controlled, multicenter studies of this strategy have been conducted. Existing studies are retrospective and confounded by heterogeneity in patients studied, therapeutic algorithms used, and outcomes reported. OBJECTIVE To determine the feasibility of conducting studies of multimodality therapy for borderline resectable pancreatic cancer in the cooperative group setting. DESIGN, SETTING, AND PARTICIPANTS A prospective, multicenter, single-arm trial of a multimodality treatment regimen administered within a study framework using centralized quality control with the cooperation of 14 member institutions of the National Clinical Trials Network. Twenty-nine patients with biopsy-confirmed pancreatic cancer preregistered, and 23 patients with tumors who met centrally reviewed radiographic criteria registered. Twenty-two patients initiated therapy (median age, 64 years [range, 50–76 years]; 55% female). Patients registered between May 29, 2013, and February 7,2014. INTERVENTIONS Patients received modified FOLFIRINOX treatment (85 mg/m2 of oxaliplatin, 180 mg/m2 of irinotecan hydrochloride, 400 mg/m2 of leucovorin calcium, and then 2400 mg/m2 of 5-fluorouracil for 4 cycles) followed by 5.5 weeks of external-beam radiation (50.4 Gy delivered in 28 daily fractions) with capecitabine (825 mg/m2 orally twice daily) prior to pancreatectomy. MAIN OUTCOMES AND MEASURES Feasibility, defined by the accrual rate, the safety of the preoperative regimen, and the pancreatectomy rate. RESULTS The accrual rate of 2.6 patients per month was superior to the anticipated rate. Although 14 of the 22 patients (64% [95% CI, 41%–83%]) had grade 3 or higher adverse events, 15 of the 22 patients (68% [95% CI, 49%–88%]) underwent pancreatectomy. Of these 15 patients, 12 (80%) required vascular resection, 14 (93%) had microscopically negative margins, 5 (33%) had specimens that had less than 5% residual cancer cells, and 2 (13%) had specimens that had pathologic complete responses. The median overall survival of all patients was 21.7 months (95% CI, 15.7 to not reached) from registration. CONCLUSIONS AND RELEVANCE The successful completion of this collaborative study demonstrates the feasibility of conducting quality-controlled trials for this disease stage in the multi-institutional setting. The data generated by this study and the logistical elements that facilitated the trial's completion are currently being used to develop cooperative group trials with the goal of improving outcomes for this subset of patients. TRIAL REGISTRATION clinicaltrials.gov Identifier: NCT01821612 PMID:27275632

Screening Poststroke Fatigue; Feasibility and Validation of an Instrument for the Screening of Poststroke Fatigue throughout the Rehabilitation Process.

PubMed

Kruithof, Nena; Van Cleef, Melanie Hubertina Maria; Rasquin, Sascha Maria Cornelia; Bovend'Eerdt, Thamar Johannes Henricus

2016-01-01

Our objective is to investigate the feasibility and validity of a new instrument to screen for determinants of poststroke fatigue during the rehabilitation process. This prospective cohort study was conducted within the stroke department of a rehabilitation center. The participants in the study were postacute adult stroke patients. The Detection List Fatigue (DLF)was administered 2 weeks after the start of the rehabilitation program and again 6 weeks later. To determine the construct validity, the Hospital Anxiety and Depression Scale, the Checklist Individual Strength subscale fatigue, and the Fatigue Severity Scale--7-item version were administered. A fatigue rating scale was used to measure the patients' fatigue experience. Frequency analyses of the number of patients reporting poststroke fatigue determinants according to the DLF were performed. One hundred seven patients (mean age 60 years) without severe communication difficulties were included in the study. The DLF was easy to understand and quick to administer. The DLF showed good internal consistency (Cronbach's alpha: .79 and .87), high convergent validity (rs = .85 and rs = .79), and good divergent validity (rs = .31 and rs = .45). The majority of the patients (88.4%-90.2%) experienced at least 2 poststroke fatigue (PSF) determinants,of which "sleeping problem" was most frequently reported. The DLF is a feasible and valid instrument for the screening of PSF determinants throughout the rehabilitation process in stroke patients. Future studies should investigate whether the use of the list in determining a treatment plan prevents the development of PSF.

A Feedback-Controlled Mandibular Positioner Identifies Individuals With Sleep Apnea Who Will Respond to Oral Appliance Therapy.

PubMed

Remmers, John E; Topor, Zbigniew; Grosse, Joshua; Vranjes, Nikola; Mosca, Erin V; Brant, Rollin; Bruehlmann, Sabina; Charkhandeh, Shouresh; Zareian Jahromi, Seyed Abdolali

2017-07-15

Mandibular protruding oral appliances represent a potentially important therapy for obstructive sleep apnea (OSA). However, their clinical utility is limited by a less-than-ideal efficacy rate and uncertainty regarding an efficacious mandibular position, pointing to the need for a tool to assist in delivery of the therapy. The current study assesses the ability to prospectively identify therapeutic responders and determine an efficacious mandibular position. Individuals (n = 202) with OSA participated in a blinded, 2-part investigation. A system for identifying therapeutic responders was developed in part 1 (n = 149); the predictive accuracy of this system was prospectively evaluated on a new population in part 2 (n = 53). Each participant underwent a 2-night, in-home feedback-controlled mandibular positioner (FCMP) test, followed by treatment with a custom oral appliance and an outcome study with the oral appliance in place. A machine learning classification system was trained to predict therapeutic outcome on data obtained from FCMP studies on part 1 participants. The accuracy of this trained system was then evaluated on part 2 participants by examining the agreement between prospectively predicted outcome and observed outcome. A predicted efficacious mandibular position was derived from each FCMP study. Predictive accuracy was as follows: sensitivity 85%; specificity 93%; positive predictive value 97%; and negative predictive value 72%. Of participants correctly predicted to respond to therapy, the predicted mandibular protrusive position proved efficacious in 86% of cases. An unattended, in-home FCMP test prospectively identifies individuals with OSA who will respond to oral appliance therapy and provides an efficacious mandibular position. The trial that this study reports on is registered on www.clinicaltrials.gov, ID NCT03011762, study name: Feasibility and Predictive Accuracy of an In-Home Computer Controlled Mandibular Positioner in Identifying Favourable Candidates for Oral Appliance Therapy. © 2017 American Academy of Sleep Medicine

[Research Progress and Development Prospect of Biomedical Plate].

PubMed

Li, Xiao; Liu, Jing; Wu, Qiang; Wang, Yanjie; Xiao, Tao; Liu, Lihong; Yu, Shu

2016-12-01

Different generations of biomedical materials are analyzed in this paper.The current clinical uses of plates made of metals,polymers or composite materials are evaluated,and nano hydroxyapatite/polylactic acid composites and carbon/carbon composite plates are introduced as emphasis.It is pointed out that the carbon/carbon composites are of great feasibility and advantage as a new generation of biomedical materials,especially in the field of bone plate.Compared to other biomaterials,carbon/carbon composites have a good biocompatibility and mechanical compatibility because they have similar elastic modulus,porosity and density to that of human bones.With the development of the technology in knitting and material preparation,carbon/carbon composite plates have a good application prospect.

Prospective cohort study of febrile neutropenia in breast cancer patients with neoadjuvant and adjuvant chemotherapy: CSPOR-BC FN study.

PubMed

Ishikawa, Takashi; Sakamaki, Kentaro; Narui, Kazutaka; Kaise, Hiroshi; Tsugawa, Koichiro; Ichikawa, Yasushi; Mukai, Hirofumi

2016-07-01

With the increasing use of adjuvant chemotherapy for treating early breast cancer, febrile neutropenia management has become crucial. Guidelines for febrile neutropenia management are mostly based on a Caucasian population survey although ethnic differences are reported in terms of adverse events. We survey the current status of febrile neutropenia and risk factors in Japanese female breast cancer patients receiving neoadjuvant and adjuvant chemotherapy regimens potential for febrile neutropenia. Subsequently, we plan to conduct a multicenter prospective cohort study involving 1000 patients with operable breast cancer. With the current state of oral antibiotics being routinely prescribed without hematology tests, we survey febrile neutropenia based on two different definitions, namely, true febrile neutropenia: ≥37.5°C and Grade 4 neutropenia, and surrogate febrile neutropenia: ≥37.5°C and oral antibiotic and antipyretic intake. The comparison of true febrile neutropenia and surrogate febrile neutropenia incidences is anticipated to provide information on the safety and feasibility of chemotherapy management without performing blood tests. © The Author 2016. Published by Oxford University Press. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

Post-acute crisis text messaging outreach for suicide prevention: a pilot study.

PubMed

Berrouiguet, Sofian; Gravey, Michel; Le Galudec, Mickaël; Alavi, Zarrin; Walter, Michel

2014-07-30

Several post-suicide prevention strategies such as sending postcards or making phone calls have been used to keep in contact with suicide attempters. The continuity of care has been beneficial to the prevention of post-acute suicidal behaviors. The aim of the study was to evaluate the technical feasibility and acceptability of text messaging outreach in post-acute suicide attempters. Eighteen post-suicidal patients were included in a prospective, monocentric, open-label, 2 months pilot study. The text messages were sent from the intranet program that we specially developed for the study. Technical feasibility of this text message intervention was evaluated by the analysis of text message reports. Acceptability of such intervention was evaluated by a standardized phone interview. Our study showed that receiving text messages sent from an intranet program after a suicide attempt is technically possible. This post-crisis outreach program was accepted by the patients who found it to have a positive preventive impact. Text messaging outreach offers several advantages such as lower cost, and easier utilization compared to current post-acute care strategies. We suggest further randomized controlled trials in a large sample of suicidal patients to assess the efficacy of this novel outreach tool for prevention of post-acute suicide. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.

Monitoring adverse drug reactions in children using community pharmacies: a pilot study

PubMed Central

Stewart, Derek; Helms, Peter; McCaig, Dorothy; Bond, Christine; McLay, James

2005-01-01

Aims To determine the feasibility of a community pharmacy-based parental adverse drug reaction (ADR) reporting system for children. Design Prospective study of parent-reported ADRs using a questionnaire issued to the parent or guardians of children 0–11 years of age collecting prescribed medicine for amoxicillin, and/or salbutamol, and collecting prescribed medicine for, or purchasing, paracetamol or ibuprofen suspension. Setting Seven community pharmacies in Grampian, Scotland. Results During a 4-week period 360 prescriptions or purchases for the study medications occurred. Two hundred and sixty-seven parents (85.5%) agreed to participate in the study. One hundred and six participants (40%) returned a total of 122 questionnaires. The demographics of responders and nonresponders including medication, age of child, and social status as assessed by the Depcat score were similar. There was no evidence of under-representation of any socio-economic group. Possible adverse events were detected using a symptom tick list and perceived ADRs using free text entry. Using the symptom tick list approach the most commonly reported symptoms were diarrhoea (28.9%) and tiredness (31.6%) for amoxicillin. The levels of diarrhoea and tiredness reported for ibuprofen, paracetamol and salbutamol were 15% and 20%, 7.4% and 18.5%, and 20% and 0%, respectively. Using the freehand section of the questionnaire 15 specific ADRs were reported by parents (12.3%). Eight children (21.2%) reported ADRs attributed to amoxicilin [diarrhoea (n = 4), fever (n = 1), anorexia (n = 1), hyperactivity (n = 1) and nonspecific (n = 1)], five to paracetamol [diarrhoea (n = 3), anorexia, irritability, crying and very angry (n = 1) and not stated (n = 1)], two to ibuprofen [diarrhoea (n = 1), not stated (n =)]. Only one off-label prescription was identified and this was for salbutamol syrup prescribed to a child under 2 years of age. Conclusions The prospective monitoring of paediatric ADRs, using a questionnaire issued to parents or guardians in the community pharmacies, is feasible. PMID:15948932

Screening for tuberculosis in an urban shelter for homeless in Switzerland: a prospective study.

PubMed

Janssens, Jean-Paul; Wuillemin, Timothee; Adler, Dan; Jackson, Yves

2017-05-16

Whereas high risk groups such as asylum seekers are systematically screened for active tuberculosis (TB) upon entry in Switzerland, this strategy does not apply to homeless persons despite a reported high risk. Geneva health and social authorities implemented an intersectoral project to screen for active TB in homeless persons. We aimed to assess acceptability of this program and prevalence of active TB in this group. This prospective study targeted all homeless adults registering for shelter accommodation in Geneva during winter 2015. Applicants were proposed a questionnaire-based screening ( www.tb-screen.ch ) exploring epidemiological and clinical risk factors for active TB. Participants with a positive score underwent diagnostic procedures at Geneva University Hospital. Enhanced TB surveillance targeting homeless persons in the community was continued 3 months after the study termination. Overall, 726/832 (87.3%) homeless persons accepted the screening procedure. Most were young male migrants without access to care in Switzerland. Male gender (adjusted OR: 2.14; 95% confidence interval: 1.27-3.62), age below 25 years (aOR: 4.16; 95% CI: 1.27-13.64) and short duration of homelessness (aOR: 1.75; 95% CI: 1.06-2.87) were predictors of acceptance. Thirty (4.1%) had positive screening scores but none of the 24 who underwent further testing had active TB. Post-study surveillance did not identify any incident case in Geneva. Active TB screening targeting highly mobile homeless persons in shelters was well accepted and feasible. The participants' sociodemographic profile highlighted the heterogeneity of homeless groups in Europe and the null TB prevalence the variability of their active TB risks. These findings underline the feasibility of health programs targeting this hard to reach group and the need for close monitoring of this social group considering the rapid changes in international mobility patterns to tailor preventive and screening strategies to the local context.

Standardised versus individualised multiherb Chinese herbal medicine for oligomenorrhoea and amenorrhoea in polycystic ovary syndrome: a randomised feasibility and pilot study in the UK.

PubMed

Lai, Lily; Flower, Andrew; Prescott, Philip; Wing, Trevor; Moore, Michael; Lewith, George

2017-02-03

To explore feasibility of a randomised study using standardised or individualised multiherb Chinese herbal medicine (CHM) for oligomenorrhoea and amenorrhoea in women with polycystic ovary syndrome (PCOS), to pilot study methods and to obtain clinical data to support sample size calculations. Prospective, pragmatic, randomised feasibility and pilot study with participant and practitioner blinding. 2 private herbal practices in the UK. 40 women diagnosed with PCOS and oligomenorrhoea or amenorrhoea following Rotterdam criteria. 6 months of either standardised CHM or individualised CHM, 16 g daily taken orally as a tea. Our primary objective was to determine whether oligomenorrhoea and amenorrhoea were appropriate as the primary outcome measures for the main study. Estimates of treatment effects were obtained for menstrual rate, body mass index (BMI), weight and hirsutism. Data were collected regarding safety, feasibility and acceptability. Of the 40 participants recruited, 29 (72.5%) completed the study. The most frequently cited symptoms of concern were hirsutism, weight and menstrual irregularity. Statistically significant improvements in menstrual rates were found at 6 months within group for both standardised CHM (mean difference (MD) 0.18±0.06, 95% CI 0.06 to 0.29; p=0.0027) and individualised CHM (MD 0.27±0.06, 95% CI 0.15 to 0.39; p<0.001), though not between group (p=0.26). No improvements were observed for BMI nor for weight in either group. Improvements in hirsutism scores found within group for both groups were not statistically significant between group (p=0.09). Liver and kidney function and adverse events data were largely normal. Participant feedback suggests changing to tablet administration could facilitate adherence. A CHM randomised controlled trial for PCOS is feasible and preliminary data suggest that both individualised and standardised multiherb CHMs have similar safety profiles and clinical effects on promoting menstrual regularity. These data will inform the design of a study in primary care that will incorporate an appropriate control. ISRCTN 31072075; Results. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.

Validation of the Spanish version of the Hip Outcome Score: a multicenter study.

PubMed

Seijas, Roberto; Sallent, Andrea; Ruiz-Ibán, Miguel Angel; Ares, Oscar; Marín-Peña, Oliver; Cuéllar, Ricardo; Muriel, Alfonso

2014-05-13

The Hip Outcome Score (HOS) is a self-reported questionnaire evaluating the outcomes of treatment interventions for hip pathologies, divided in 19 items of activities of daily life (ADL) and 9 sports' items. The aim of the present study is to translate and validate HOS into Spanish. A prospective and multicenter study with 100 patients undergoing hip arthroscopy was performed between June 2012 and January 2013. Crosscultural adaptation was used to translate HOS into Spanish. Patients completed the questionnaire before and after surgery. Feasibility, reliability, internal consistency, construct validity (correlation with Western Ontario and McMaster Universities Osteoarthritis Index), ceiling and floor effects and sensitivity to change were assessed for the present study. Mean age was 45.05 years old. 36 women and 64 men were included. Feasibility: 13% had at least one missing item within the ADL subscale and 17% within the sport subscale. Reliability: the translated version of HOS was highly reproducible with intraclass correlation coefficient of 0.95 for ADL and 0.94 for the sports subscale. Internal consistency was confirmed with Cronbach's alpha >0.90 in both subscales. Construct validity showed statistically significant correlation with WOMAC. Ceiling effect was observed in 6% and 12% for ADL and sports subscale, respectively. Floor effect was found in 3% and 37% ADL and sports subscale, respectively. Large sensitivity to change was shown in both subscales. The translated version of HOS into Spanish has shown to be feasible, reliable and sensible to changes for patients undergoing hip arthroscopy. This validated translation of HOS allows for comparisons between studies involving either Spanish- or English-speaking patients. Prognostic study, Level I.

Biomolecular characterization of glass surfaces

NASA Astrophysics Data System (ADS)

Clare, Alexis G.; Hall, Matthew M.; Korwin-Edson, Michelle L.; Goldstein, Alan H.

2003-08-01

This paper introduces the concept of biomolecular characterization of inorganic surfaces. The choice of biomolecule is discussed followed by techniques that can be used to analyse the quantity of bound species, strength of binding, the nature of binding sites, conformational changes and the layer morphology. The prospects of modelling this data using a combination of molecular dynamics simulation and protein structural modelling and the correlation to measured data are outlined. The studies described in this paper are directed toward assessing the feasibility of biomolecular characterization, however, the data collected in the process are designed to also help elucidate our understanding of the interaction between biomolecular species and inorganic materials interfaces.

Ultrasound-Guided 50% Ethyl Alcohol Injection for Patients With Malleolar and Olecranon Bursitis: A Prospective Pilot Study

PubMed Central

Hong, Ji Seong; Lee, Jin Hyung

2016-01-01

Objective To evaluate the feasibility and effect of ultrasound-guided ethyl alcohol injection on malleolar and olecranon synovial proliferative bursitis. Methods Twenty-four patients received ultrasound-guided 50% diluted ethyl alcohol injection at the site of synovial proliferative bursitis after aspiration of the free fluid. Results Swelling and symptoms significantly decreased in 13 of the 24 patients without any complications. Eleven patients had partial improvement in swelling and symptoms. Conclusion Ultrasound-guided alcohol injection could be an alternative therapeutic option before surgery in patients with chronic intractable malleolar and olecranon synovial proliferative bursitis. PMID:27152282

Rapid sequence induction of anaesthesia via the intraosseous route: a prospective observational study.

PubMed

Barnard, E B G; Moy, R J; Kehoe, A D; Bebarta, V S; Smith, J E

2015-06-01

Intraosseous (IO) drug infusion has been reported to have similar pharmacokinetics to intravenous (IV) infusion. In military and civilian trauma, the IO route is often used to obtain rapid and reliable parenteral access for drug administration. Only a few case reports have described the use of IO infusion to administer drugs for rapid sequence induction of anaesthesia (RSI). We aimed to assess the feasibility of the administration of RSI drugs via an IO catheter in a prospective observational study. A prospective observational study was undertaken at a combat hospital in Afghanistan. A validated data form was used to record the use of IO drugs for RSI by the prehospital, physician-led Medical Emergency Response Team (MERT), and by inhospital physicians. Data were captured between January and May 2012 by interview with MERT physicians and inhospital physicians directly after RSI. The primary outcome measure was the success rate of first-pass intubation with direct laryngoscopy. 34 trauma patients (29 MERT and 5 inhospital) underwent RSI with IO drug administration. The median age was 24 years and median injury severity score 25; all were male. The predominant mechanism of injury was blast (n=24), followed by penetrating (n=6), blunt (n=3) and burn (n=1). First-pass intubation success rate was 97% (95% CI 91% to 100%). A Cormack-Lehane grade 1 view, by direct laryngoscopy, was obtained at first look in 91% (95% CI 81% to 100%) of patients. In this prospective, observational study, IO drug administration was successfully used for trauma RSI, with a comparable first pass intubation success than published studies describing the IV route. RCDM/Res/Audit/1036/12/0162. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

Development of a PROficiency-Based StePwise Endovascular Curricular Training (PROSPECT) Program.

PubMed

Maertens, Heidi; Aggarwal, Rajesh; Desender, Liesbeth; Vermassen, Frank; Van Herzeele, Isabelle

2016-01-01

Focus on patient safety, work-hour limitations, and cost-effective education is putting pressure to improve curricula to acquire minimally invasive techniques during surgical training. This study aimed to design a structured training program for endovascular skills and validate its assessment methods. A PROficiency-based StePwise Endovascular Curricular Training (PROSPECT) program was developed, consisting of e-learning and hands-on simulation modules, focusing on iliac and superficial femoral artery atherosclerotic disease. Construct validity was investigated. Performances were assessed using multiple-choice questionnaires, valid simulation parameters, global rating scorings, and examiner checklists. Feasibility was assessed by passage of 2 final-year medical students through this PROSPECT program. Ghent University Hospital, a tertiary clinical care and academic center in Belgium with general surgery residency program. Senior-year medical students were recruited at Ghent University Hospital. Vascular surgeons were invited to participate during conferences and meetings if they had performed at least 100 endovascular procedures as the primary operator during the last 2 years. Overall, 29 medical students and 20 vascular surgeons participated. Vascular surgeons obtained higher multiple-choice questionnaire scores (median: 24.5-22.0 vs. 15.0-12.0; p < 0.001). Students took significantly longer to treat any iliac or femoral artery stenosis (3.3-14.8 vs. 5.8-30.1min; p = 0.001-0.04), whereas in more complex cases, fluoroscopy time was significantly higher in students (8.3 vs. 21.3min; p = 0.002; 7.3 vs. 13.1min; p = 0.03). In all cases, vascular surgeons scored higher on global rating scorings (51.0-42.0 vs. 29.5-18.0; p < 0.001) and examiner checklist (81.5-75.0 vs. 54.5-43.0; p < 0.001). Hence, proficiency levels based on median expert scores could be determined. There were 2 students who completed the program and passed for each step within a 3-month period during their internships. A feasible and construct validated surgical program to train cognitive, technical, and nontechnical endovascular skills was developed. A structured, stepwise, proficiency-based valid endovascular program to train cognitive, technical, and human factor skills has been developed and proven to be feasible. A randomized controlled trial has been initiated to investigate its effect on performances in real life, patient outcomes, and cost-effectiveness. Copyright © 2015 Association of Program Directors in Surgery. Published by Elsevier Inc. All rights reserved.

Tricuspid Annular Geometry: A Three-Dimensional Transesophageal Echocardiographic Study

PubMed Central

Mahmood, Feroze; Kim, Han; Chaudary, Bilal; Bergman, Remco; Matyal, Robina; Gerstle, Jeniffer; Gorman, Joseph H.; Gorman, Robert C.; Khabbaz, Kamal R.

2013-01-01

Objective To demonstrate the clinical feasibility of accurately measuring tricuspid annular area by 3-dimensional (3D) transesophageal echocardiography (TEE) and to assess the geometric differences based on the presence of tricuspid regurgitation (TR). Also, the shape of the tricuspid annulus was compared with previous descriptions in the literature. Design Prospective. Setting Tertiary care university hospital. Interventions Three-dimensional TEE. Participants Patients undergoing cardiac surgery. Measurements and Main Results Volumetric data sets from 20 patients were acquired by 3D TEE and prospectively analyzed. Comparisons in annular geometry were made between groups based on the presence of TR. The QLab (Philips Medical Systems, Andover, MA) software package was used to calculate tricuspid annular area by both linear elliptical dimensions and planimetry. Further analyses were performed in the 4D Cardio-View (TomTec Corporation GmBH, Munich, Germany) and MATLAB (Natick, MA) software environments to accurately assess annular shape. It was found that patients with greater TR had an eccentrically dilated annulus with a larger annular area. Also, the area as measured by the linear ellipse method was overestimated as compared to the planimetry method. Furthermore, the irregular saddle-shaped geometry of the tricuspid annulus was confirmed through the mathematic model developed by the authors. Conclusions Three-dimensional TEE can be used to measure the tricuspid annular area in a clinically feasible fashion, with an eccentric dilation seen in patients with TR. The tricuspid annulus shape is complex, with annular high and low points, and annular area calculation based on linear measurements significantly overestimates 3D planimetered area. PMID:23725682

DOE Office of Scientific and Technical Information (OSTI.GOV)

Denys, Alban, E-mail: alban.denys@chuv.ch; Lachenal, Yann; Duran, Rafael

PurposeTo report feasibility and potential benefits of high-frequency jet ventilation (HFJV) in tumor ablations techniques in liver, kidney, and lung lesions.MethodsThis prospective study included 51 patients (14 women, mean age 66 years) bearing 66 tumors (56 hepatic, 5 pulmonary, 5 renal tumors) with a median size of 16 ± 8.7 mm, referred for tumor ablation in an intention-to-treat fashion before preoperative anesthesiology visit. Cancellation and complications of HFJV were prospectively recorded. Anesthesia and procedure duration, as well as mean CO{sub 2} capnea, were recorded. When computed tomography guidance was used, 3D spacial coordinates of an anatomical target <2 mm in diameter on 8 slabs ofmore » 4 slices of 3.75-mm slice thickness were registered.ResultsHFJV was used in 41 of 51 patients. Of the ten patients who were not candidate for HFJV, two patients had contraindication to HFJV (severe COPD), three had lesions invisible under HFJV requiring deep inspiration apnea for tumor targeting, and five patients could not have HFJV because of unavailability of a trained anesthetic team. No specific complication or hypercapnia related to HFJV were observed despite a mean anesthetic duration of 2 h and ventilation performed in procubitus (n = 4) or lateral decubitus (n = 6). Measured internal target movement was 0.3 mm in x- and y-axis and below the slice thickness of 3.75 mm in the z-axis in 11 patients.ConclusionsHFJV is feasible in 80 % of patients allowing for near immobility of internal organs during liver, kidney, and lung tumor ablation.« less

Real-time fusion of coronary CT angiography with x-ray fluoroscopy during chronic total occlusion PCI.

PubMed

Ghoshhajra, Brian B; Takx, Richard A P; Stone, Luke L; Girard, Erin E; Brilakis, Emmanouil S; Lombardi, William L; Yeh, Robert W; Jaffer, Farouc A

2017-06-01

The purpose of this study was to demonstrate the feasibility of real-time fusion of coronary computed tomography angiography (CTA) centreline and arterial wall calcification with x-ray fluoroscopy during chronic total occlusion (CTO) percutaneous coronary intervention (PCI). Patients undergoing CTO PCI were prospectively enrolled. Pre-procedural CT scans were integrated with conventional coronary fluoroscopy using prototype software. We enrolled 24 patients who underwent CTO PCI using the prototype CT fusion software, and 24 consecutive CTO PCI patients without CT guidance served as a control group. Mean age was 66 ± 11 years, and 43/48 patients were men. Real-time CTA fusion during CTO PCI provided additional information regarding coronary arterial calcification and tortuosity that generated new insights into antegrade wiring, antegrade dissection/reentry, and retrograde wiring during CTO PCI. Overall CTO success rates and procedural outcomes remained similar between the two groups, despite a trend toward higher complexity in the fusion CTA group. This study demonstrates that real-time automated co-registration of coronary CTA centreline and calcification onto live fluoroscopic images is feasible and provides new insights into CTO PCI, and in particular, antegrade dissection reentry-based CTO PCI. • Real-time semi-automated fusion of CTA/fluoroscopy is feasible during CTO PCI. • CTA fusion data can be toggled on/off as desired during CTO PCI • Real-time CT calcium and centreline overlay could benefit antegrade dissection/reentry-based CTO PCI.

Feasibility and outcomes of combined transcatheter aortic valve replacement with other structural heart interventions in a single session: a matched cohort study.

PubMed

Khattab, Ahmed A; Gloekler, Steffen; Sprecher, Beate; Shakir, Samera; Guerios, Enio; Stortecky, Stefan; O'Sullivan, Crochan J; Nietlispach, Fabian; Moschovitis, Aris; Pilgrim, Thomas; Buellesfeld, Lutz; Wenaweser, Peter; Windecker, Stephan; Meier, Bernhard

2014-01-01

Concurrent cardiac diseases are frequent among elderly patients and invite simultaneous treatment to ensure an overall favourable patient outcome. To investigate the feasibility of combined single-session percutaneous cardiac interventions in the era of transcatheter aortic valve implantation (TAVI). This prospective, case-control study included 10 consecutive patients treated with TAVI, left atrial appendage occlusion and percutaneous coronary interventions. Some in addition had patent foramen ovale or atrial septal defect closure in the same session. The patients were matched in a 1:10 manner with TAVI-only cases treated within the same time period at the same institution regarding their baseline factors. The outcome was validated according to the Valve Academic Research Consortium (VARC) criteria. Procedural time (126±42 vs 83±40 min, p=0.0016), radiation time (34±8 vs 22±12 min, p=0.0001) and contrast dye (397±89 vs 250±105 mL, p<0.0001) were higher in the combined intervention group than in the TAVI-only group. Despite these drawbacks, no difference in the VARC endpoints was evident during the in-hospital period and after 30 days (VARC combined safety endpoint 32% for TAVI only and 20% for combined intervention, p=1.0). Transcatheter treatment of combined cardiac diseases is feasible even in a single session in a high-volume centre with experienced operators.

Text Messaging Improves Participation in Laboratory Testing in Adolescent Liver Transplant Patients.

PubMed

McKenzie, Rebecca B; Berquist, William E; Foley, Megan A; Park, K T; Windsheimer, Jered E; Litt, Iris F

In solid organ transplant patients, non-participation in all aspects of the medical regimen is a prevalent problem associated with adverse consequences particularly in the adolescent and young adult (AYA) age group. This study is the first to evaluate the feasibility, utility and impact of a text messaging (TM) intervention to improve participation in laboratory testing in adolescent liver transplant patients. AYA patients, aged 12 to 21 years, were recruited for a prospective pilot trial evaluating a TM intervention delivered over a 1-year period. The intervention involved automated TM reminders with feedback administered according to a prescribed laboratory testing frequency. Participation rate in laboratory testing after the intervention was compared to the year prior. Patient responses and feedback by text and survey were used to assess feasibility, acceptability and use of the intervention. Forty-two patients were recruited and 33 patients remained enrolled for the study duration. Recipients of the TM intervention demonstrated a significant improvement in participation rate in laboratory testing from 58% to 78% (P<.001). This rate was also significantly higher than in non-intervention controls (P=.003). There was a high acceptability, response rate and a significant correlation with reported versus actual completion of laboratory tests by TM. TM reminders significantly improved participation in laboratory testing in AYA liver transplant patients. The intervention demonstrated feasibility, acceptability, and use with a high proportion of patients who engaged in and perceived a benefit from using this technology.

The feasibility of measuring renal blood flow using transesophageal echocardiography in patients undergoing cardiac surgery.

PubMed

Yang, Ping-Liang; Wong, David T; Dai, Shuang-Bo; Song, Hai-Bo; Ye, Ling; Liu, Jin; Liu, Bin

2009-05-01

There is no reliable method to monitor renal blood flow intraoperatively. In this study, we evaluated the feasibility and reproducibility of left renal blood flow measurements using transesophageal echocardiography during cardiac surgery. In this prospective noninterventional study, left renal blood flow was measured with transesophageal echocardiography during three time points (pre-, intra-, and postcardiopulmonary bypass) in 60 patients undergoing cardiac surgery. Sonograms from 6 subjects were interpreted by 2 blinded independent assessors at the time of acquisition and 6 mo later. Interobserver and intraobserver reproducibility were quantified by calculating variability and intraclass correlation coefficients. Patients with Doppler angles of >30 degrees (20 of 60 subjects) were eliminated from renal blood flow measurements. Left renal blood flow was successfully measured and analyzed in 36 of 60 (60%) subjects. Both interobserver and intraobserver variability were <10%. Interobserver and intraobserver reproducibility in left renal blood flow measurements were good to excellent (intraclass correlation coefficients 0.604-0.999). Left renal arterial luminal diameter for the pre, intra, and postcardiopulmonary bypass phases, ranged from 3.8 to 4.1 mm, renal arterial velocity from 25 to 35 cm/s, and left renal blood flow from 192 to 299 mL/min. In patients undergoing cardiac surgery, it was feasible in 60% of the subjects to measure left renal blood flow using intraoperative transesophageal echocardiography. The interobserver and intraobserver reproducibility of renal blood flow measurements was good to excellent.

Feasibility and outcomes of combined transcatheter aortic valve replacement with other structural heart interventions in a single session: a matched cohort study

PubMed Central

Khattab, Ahmed A; Gloekler, Steffen; Sprecher, Beate; Shakir, Samera; Guerios, Ênio; Stortecky, Stefan; O'Sullivan, Crochan J; Nietlispach, Fabian; Moschovitis, Aris; Pilgrim, Thomas; Buellesfeld, Lutz; Wenaweser, Peter; Windecker, Stephan; Meier, Bernhard

2014-01-01

Background Concurrent cardiac diseases are frequent among elderly patients and invite simultaneous treatment to ensure an overall favourable patient outcome. Aim To investigate the feasibility of combined single-session percutaneous cardiac interventions in the era of transcatheter aortic valve implantation (TAVI). Methods This prospective, case–control study included 10 consecutive patients treated with TAVI, left atrial appendage occlusion and percutaneous coronary interventions. Some in addition had patent foramen ovale or atrial septal defect closure in the same session. The patients were matched in a 1:10 manner with TAVI-only cases treated within the same time period at the same institution regarding their baseline factors. The outcome was validated according to the Valve Academic Research Consortium (VARC) criteria. Results Procedural time (126±42 vs 83±40 min, p=0.0016), radiation time (34±8 vs 22±12 min, p=0.0001) and contrast dye (397±89 vs 250±105 mL, p<0.0001) were higher in the combined intervention group than in the TAVI-only group. Despite these drawbacks, no difference in the VARC endpoints was evident during the in-hospital period and after 30 days (VARC combined safety endpoint 32% for TAVI only and 20% for combined intervention, p=1.0). Conclusions Transcatheter treatment of combined cardiac diseases is feasible even in a single session in a high-volume centre with experienced operators. PMID:25332781

Transferring Patients From Methadone to Buprenorphine: The Feasibility and Evaluation of Practice Guidelines.

PubMed

Lintzeris, Nicholas; Monds, Lauren A; Rivas, Consuelo; Leung, Stefanie; Dunlop, Adrian; Newcombe, David; Walters, Carina; Galea, Susanna; White, Nancy; Montebello, Mark; Demirkol, Apo; Swanson, Nicola; Ali, Robert

Transfer from methadone to buprenorphine is problematic for many opioid-dependent patients, with limited documented evidence or practical clinical guidance, particularly for the range of methadone doses routinely prescribed for most patients (>50 mg). This study aimed to implement and evaluate recent national Australian guidelines for transferring patients from methadone to buprenorphine. A multisite prospective cohort study. Participants were patients who transferred from methadone to buprenorphine-naloxone at 1 of 4 specialist addiction centers in Australia and New Zealand. Clinicians were trained in the guidelines, and medical records were reviewed to examine process (eg, transfer setting, doses, and guideline adherence) and safety (precipitated withdrawal) measures. Participants completed research interviews before and after transfer-assessing changes in substance use, health outcomes, and side effects. In all, 33 participants underwent transfer, 9 from low methadone doses (<30 mg), 9 from medium doses (30-50 mg), and 15 from high doses (>50 mg). The majority of high-dose transfers occurred in inpatient settings. There was reasonable guideline adherence, and no complications identified in the low and medium-dose transfers. Three high-dose transfers (20%) experienced precipitated withdrawal, and 7/33 participants (21%) returned to methadone within 1 week of attempted transfer. Transfer is feasible in outpatient settings for those transferring from methadone doses below 50 mg; however, inpatient settings and specialist supervision is recommended for higher-dose transfers. The Australian clinical guidelines appear safe and feasible, although further research is required to optimize high-dose transfer procedures.

3D laparoscopic surgery: a prospective clinical trial.

PubMed

Agrusa, Antonino; Di Buono, Giuseppe; Buscemi, Salvatore; Cucinella, Gaspare; Romano, Giorgio; Gulotta, Gaspare

2018-04-03

Since it's introduction, laparoscopic surgery represented a real revolution in clinical practice. The use of a new generation three-dimensional (3D) HD laparoscopic system can be considered a favorable "hybrid" made by combining two different elements: feasibility and diffusion of laparoscopy and improved quality of vision. In this study we report our clinical experience with use of three-dimensional (3D) HD vision system for laparoscopic surgery. Between 2013 and 2017 a prospective cohort study was conducted at the University Hospital of Palermo. We considered 163 patients underwent to laparoscopic three-dimensional (3D) HD surgery for various indications. This 3D-group was compared to a retrospective-prospective control group of patients who underwent the same surgical procedures. Considerating specific surgical procedures there is no significant difference in term of age and gender. The analysis of all the groups of diseases shows that the laparoscopic procedures performed with 3D technology have a shorter mean operative time than comparable 2D procedures when we consider surgery that require complex tasks. The use of 3D laparoscopic technology is an extraordinary innovation in clinical practice, but the instrumentation is still not widespread. Precisely for this reason the studies in literature are few and mainly limited to the evaluation of the surgical skills to the simulator. This study aims to evaluate the actual benefits of the 3D laparoscopic system integrating it in clinical practice. The three-dimensional view allows advanced performance in particular conditions, such as small and deep spaces and promotes performing complex surgical laparoscopic procedures.

Monitoring of cerebral oxygen saturation during resuscitation in out-of-hospital cardiac arrest: a feasibility study in a physician staffed emergency medical system.

PubMed

Schewe, Jens-Christian; Thudium, Marcus O; Kappler, Jochen; Steinhagen, Folkert; Eichhorn, Lars; Erdfelder, Felix; Heister, Ulrich; Ellerkmann, Richard

2014-10-05

Despite recent advances in resuscitation algorithms, neurological injury after cardiac arrest due to cerebral ischemia and reperfusion is one of the reasons for poor neurological outcome. There is currently no adequate means of measuring cerebral perfusion during cardiac arrest. It was the aim of this study to investigate the feasibility of measuring near infrared spectroscopy (NIRS) as a potential surrogate parameter for cerebral perfusion in patients with out-of-hospital resuscitations in a physician-staffed emergency medical service. An emergency physician responding to out-of-hospital emergencies was equipped with a NONIN cerebral oximetry device. Cerebral oximetry values (rSO2) were continuously recorded during resuscitation and transport. Feasibility was defined as >80% of total achieved recording time in relation to intended recording time. 10 patients were prospectively enrolled. In 89.8% of total recording time, rSO2 values could be recorded (213 minutes and 20 seconds), thus meeting feasibility criteria. 3 patients experienced return of spontaneous circulation (ROSC). rSO2 during manual cardiopulmonary resuscitation (CPR) was lower in patients who did not experience ROSC compared to the 3 patients with ROSC (31.6%, ± 7.4 versus 37.2% ± 17.0). ROSC was associated with an increase in rSO2. Decrease of rSO2 indicated occurrence of re-arrest in 2 patients. In 2 patients a mechanical chest compression device was used. rSO2 values during mechanical compression were increased by 12.7% and 19.1% compared to manual compression. NIRS monitoring is feasible during resuscitation of patients with out-of-hospital cardiac arrest and can be a useful tool during resuscitation, leading to an earlier detection of ROSC and re-arrest. Higher initial rSO2 values during CPR seem to be associated with the occurrence of ROSC. The use of mechanical chest compression devices might result in higher rSO2. These findings need to be confirmed by larger studies.

Feasibility of high-intensity interval training and moderate-intensity continuous training in adults with inactive or mildly active Crohn's disease: study protocol for a randomised controlled trial.

PubMed

Tew, Garry A; Carpenter, Roger; Seed, Michael; Anderson, Simon; Langmead, Louise; Fairhurst, Caroline; Bottoms, Lindsay

2017-01-01

Structured exercise training has been proposed as a useful adjunctive therapy for Crohn's disease by improving immune function and psychological health, reducing fatigue and promoting gains in muscle and bone strength. However, the evidence for exercise in Crohn's disease is sparse, with only a handful of small prospective trials [1, 2], with methodological limitations, including the use of non-randomised and non-controlled study designs and small sample sizes. Here, we describe the protocol for a study that aims to assess the feasibility and acceptability of two common types of exercise training-high-intensity interval training (HIIT) and moderate-intensity continuous training (MICT)-in adults with inactive or mildly active Crohn's disease (CD). This is a randomised, controlled, assessor-blinded, feasibility trial with three parallel groups. Forty-five adults with inactive or mildly active Crohn's disease will be randomly assigned 1:1:1 to HIIT, MICT or usual care control. Participants in the HIIT and MICT groups will be invited to undertake three sessions of supervised exercise each week for 12 consecutive weeks. HIIT sessions will consist of ten 1-min intervals of cycling exercise at 90% of peak power output separated by 1 min of active recovery. MICT sessions will involve 30 min of continuous cycling at 35% of peak power output. Participants will be assessed before randomisation and 13 and 26 weeks after randomisation. Feasibility outcomes include rates of recruitment, retention and adherence. Interviews with participants will explore the acceptability of the exercise programmes and study procedures. Clinical/health outcomes include cardiorespiratory fitness, body mass index, resting blood pressure, markers of disease activity (faecal calprotectin and Crohn's Disease Activity Index) and activated T cell cytokine profiles. Study questionnaires include the Inflammatory Bowel Disease Quality of Life Questionnaire, EQ-5D-5L, IBD Fatigue Scale, Hospital and Anxiety Depression Scale, and International Physical Activity Questionnaire. This study will provide useful information on the feasibility and acceptability of supervised exercise training in adults with inactive and mildly active Crohn's disease and will inform the design of a subsequent, adequately powered, multi-centre trial. The trial is registered with the International Standard Randomised Controlled Trial Register (ISRCTN13021107). Date registration assigned was 02/12/2015.

Feasibility of a multicentre, randomised controlled trial of laparoscopic versus open colorectal surgery in the acute setting: the LaCeS feasibility trial protocol.

PubMed

Harji, Deena; Marshall, Helen; Gordon, Katie; Crow, Hannah; Hiley, Victoria; Burke, Dermot; Griffiths, Ben; Moriarty, Catherine; Twiddy, Maureen; O'Dwyer, John L; Verjee, Azmina; Brown, Julia; Sagar, Peter

2018-02-22

Acute colorectal surgery forms a significant proportion of emergency admissions within the National Health Service. There is limited evidence to suggest minimally invasive surgery may be associated with improved clinical outcomes in this cohort of patients. Consequently, there is a need to assess the clinical effectiveness and cost-effectiveness of laparoscopic surgery in the acute colorectal setting. However,emergency colorectal surgical trials have previously been difficult to conduct due to issues surrounding recruitment and equipoise. The LaCeS (randomised controlled trial of Laparoscopic versus open Colorectal Surgery in the acute setting) feasibility trial will determine the feasibility of conducting a definitive, phase III trial of laparoscopic versus open acute colorectal resection. The LaCeS feasibility trial is a prospective, multicentre, single-blinded, parallel group, pragmatic randomised controlled feasibility trial. Patients will be randomised on a 1:1 basis to receive eitherlaparoscopic or open surgery. The trial aims to recruit at least 66 patients from five acute general surgical units across the UK. Patients over the age of 18 with a diagnosis of acute colorectal pathology requiring resection on clinical and radiological/endoscopic investigations, with a National Confidential Enquiry into Patient Outcome and Death classification of urgent will be considered eligible for participation. The primary outcome is recruitment. Secondary outcomes include assessing the safety profile of laparoscopic surgery using intraoperative and postoperative complication rates, conversion rates and patient-safety indicators as surrogate markers. Clinical and patient-reported outcomes will also be reported. The trial will contain an embedded qualitative study to assess clinician and patient acceptability of trial processes. The LaCeS feasibility trial is approved by the Yorkshire and The Humber, Bradford Leeds Research Ethics Committee (REC reference: 15/ YH/0542). The results from the trial will be presented at national and international colorectal conferences and will be submitted for publication to peer-reviewed journals. ISRCTN15681041; Pre-results. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

The Feasibility of Using Computer and Internet in Teaching Family Education for the 8th Grade Class

ERIC Educational Resources Information Center

Alluhaydan, Nuwayyir Saleh F.

2016-01-01

This paper is just a sample template for the prospective authors of IISTE. Over the decades, the concepts of holons and holonic systems have been adopted in many research fields, but they are scarcely attempted on labour planning. A literature gap exists, thus motivating the author to come up with a holonic model that uses exponential smoothing to…

How to make the fourth revolution: Human factors in the adoption of electronic instructional aids

NASA Technical Reports Server (NTRS)

Demerath, N. J.; Daniels, L. A.

1973-01-01

The prospects and problems of getting higher education in the United States (high school and above) to more fully utilize electronic technologies are examined. Sociological, psychological, and political factors are analyzed to determine the feasibility of adopting electronic instructional techniques. Differences in organizations, attitudes, and customs of different kinds of students, teachers, administrators, and publics are crucial factors in innovation.

Weight-bearing recommendations after operative fracture treatment-fact or fiction? Gait results with and feasibility of a dynamic, continuous pedobarography insole.

PubMed

Braun, Benedikt J; Veith, Nils T; Rollmann, Mika; Orth, Marcel; Fritz, Tobias; Herath, Steven C; Holstein, Jörg H; Pohlemann, Tim

2017-08-01

Rehabilitation after lower-extremity fractures is based on the physicians' recommendation for non-, partial-, or full weight-bearing. Clinical studies rely on this assumption, but continuous compliance or objective loading rates are unknown. The purpose of this study was to determine the compliance to weight-bearing recommendations by introducing a novel, pedobarography system continuously registering postoperative ground forces into ankle, tibial shaft and proximal femur fracture aftercare and test its feasibility for this purpose. In this prospective, observational study, a continuously measuring pedobarography insole was placed in the patients shoe during the immediate post-operative aftercare after ankle, tibial shaft and intertrochanteric femur fractures. Weight-bearing was ordered as per the institutional standard and controlled by physical therapy. The insole was retrieved after a maximum of six weeks (28 days [range 5-42 days]). Non-compliance was defined as a failure to maintain, or reach the ordered weight-bearing within 30%. Overall 30 patients were included in the study. Fourteen (47%) of the patients were compliant to the weight-bearing recommendations. Within two weeks after surgery patients deviated from the recommendation by over 50%. Sex, age and weight did not influence the performance (p > 0.05). Ankle fracture patients (partial weight-bearing) showed a significantly increased deviation from the recommendation (p = 0.01). Our study results show that, despite physical therapy training, weight-bearing compliance to recommended limits was low. Adherence to the partial weight-bearing task was further decreased over time. Uncontrolled weight-bearing recommendations should thus be viewed with caution and carefully considered as fiction. The presented insole is feasible to determine weight bearing continuously, could immediately help define real-time patient behaviour and establish realistic, individual weight-bearing recommendations.

Feasibility of transnasal endoscopy in screening for esophageal and gastric varices in patients with chronic liver disease

PubMed Central

de Faria, Anderson Antônio; Dias, Carlos Alberto Freitas; Dias Moetzsohn, Luciana; de Castro Carvalho, Silas; Ferrari, Tereza Abreu; Nunes Arantes, Vitor

2017-01-01

Background and study aims  Screening for esophageal and gastric varices is indicated for patients with portal hypertension or cirrhosis. Typically, conventional endoscopy is used; however, the need for sedation increases the costs and risks, especially in cirrhotic patients. Use of transnasal endoscopy with an ultrathin endoscope enables study of the upper gastrointestinal tract without the need for sedation. The objective of this study is to evaluate the feasibility of transnasal endoscopy in screening for esophageal and gastric varices in patients with chronic liver disease. Patients and methods  This was a prospective study in which transnasal endoscopy was carried out in patients with cirrhosis or portal hypertension who had indications for screening of esophageal and gastric varices. The following variables were evaluated: demographical data, duration of procedure, patient tolerance and acceptance, adverse events (AEs), endoscopic findings and interobserver agreement related to portal hypertension alterations ( kappa index). Results  A total of 50 patients entered the study. The most common cause of liver disease was chronic viral hepatitis (66 %). Among the cirrhotic patients, most of the patients were Child-Pugh A (74 %). In 5 patients (10 %), nasal intubation was not possible. Two patients (4 %) experienced minor epistaxis. Tolerance was excellent or good in 92 % according with a visual analogic scale. In 16 patients (32 %), esophageal varices were detected and in 2 patients (4 %) gastric varices were detected. The mean duration of the procedure was 7 minutes. Conclusions  Transnasal endoscopy is feasible, effective and well tolerated for screening of esophageal and gastric varices in patients with chronic liver disease. It can be performed in outpatient clinics safely and without the use of sedation. PMID:28691048

Home-Based Screening for Biliary Atresia Using Infant Stool Color Cards in Canada: Quebec Feasibility Study.

PubMed

Morinville, Véronique; Ahmed, Najma; Ibberson, Cindy; Kovacs, Lajos; Kaczorowski, Janusz; Bryan, Stirling; Collet, Jean-Paul; Schreiber, Richard

2016-04-01

Biliary atresia (BA) is a leading cause of liver failure and liver transplantation in pediatrics. BA manifests by 3 weeks of life with jaundice and pale stools. Delayed diagnosis and surgical intervention with Kasai portoenterostomy after 3 months of age is significantly associated with poor prognosis for native liver survival. A national Taiwan infant stool color card (SCC) screening program has entirely eliminated late Kasai portoenterostomy >90 days of age and improved native liver survival. A recent large-scale prospective cohort study in British Columbia, Canada, indicated that distribution of SCC on the maternity ward was feasible, led to high utilization rate, and was cost-effective. The aim of the present study was to assess the generalizability of this screening strategy in another Canadian jurisdiction with a different sociodemographic profile. An SCC was distributed to families of newborns discharged at St Mary's Hospital Center, Montreal, Quebec. Families were instructed to monitor their infant's stool color for 21 days and then complete and mail the SCC to the study center. Phone surveys to families who did not return cards were used to estimate total card utilization rate. Two thousand two hundred forty-six infants were eligible for inclusion; 99.9% were enrolled. Mail SCC return rate was 63.3%. No cases of BA were identified. All of the 118 families who completed the phone survey reported that they had utilized the SCC. Conservative and optimistic estimates for total card utilization rates were 82% and 100%, respectively. The high enrollment and utilization rates in this screening study strongly support the feasibility of implementing a Canadian SCC screening program to improve outcomes of children with BA.

Development of a Web Portal for Physical Activity and Symptom Tracking in Oncology Patients: Protocol for a Prospective Cohort Study.

PubMed

Marthick, Michael; Dhillon, Haryana M; Alison, Jennifer A; Cheema, Birinder S; Shaw, Tim

2018-05-15

Significant benefits accrue from increasing physical activity levels in people with a history of cancer. Physical activity levels can be increased using behavioral change interventions in this population. Access to Web portals and provision of activity monitors to provide feedback may support behavior change by encouraging patient engagement in physical therapy. The Web portal evaluated in this study will provide a system to monitor physical activity and sleep, for use by both clinician and patient, along with symptom and health-related quality of life tracking capabilities. The aim of this study was to outline a protocol for a feasibility study focused on a Web-based portal that provides activity monitoring and personalized messaging to increase physical activity in people with cancer. Using a longitudinal cohort design, people with cancer will be serially allocated to 3 intervention cohorts of 20 participants each and followed for 10 weeks. Cohort 1 will be provided a wearable activity monitor and access to a Web-based portal. Cohort 2 will receive the same content as Cohort 1 and in addition will receive a weekly activity summary message. Cohort 3 will receive the same content as Cohorts 1 and 2 and in addition will receive a personalized weekly coaching message. Feasibility of the use of the portal is the primary outcome. Results are expected in early 2018. Outcome measures will include goal attainment and completion rate. This study will provide information about the feasibility of investigating eHealth initiatives to promote physical activity in people with cancer. RR1-10.2196/9586. ©Michael Marthick, Haryana M Dhillon, Jennifer A Alison, Birinder S Cheema, Tim Shaw. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 15.05.2018.

Rehabilitation program after mesenchymal stromal cell transplantation augmented by vascularized bone grafts for idiopathic osteonecrosis of the femoral head: a preliminary study.

PubMed

Aoyama, Tomoki; Fujita, Yasuko; Madoba, Katsuyuki; Nankaku, Manabu; Yamada, Minoru; Tomita, Motoko; Goto, Koji; Ikeguchi, Ryosuke; Kakinoki, Ryosuke; Matsuda, Shuichi; Nakamura, Takashi; Toguchida, Junya

2015-03-01

To determine the feasibility and safety of implementing a 12-week rehabilitation program after mesenchymal stromal cell (MSC) transplantation augmented by vascularized bone grafting for idiopathic osteonecrosis (ION) of the femoral head. A prospective case series. University clinical research laboratory. Participants (N=10) with ION who received MSC transplantation augmented by vascularized bone grafting. A 12-week exercise program, which included range-of-motion (ROM) exercises, muscle-strengthening exercises, and aerobic training. Measures of ROM, muscle strength, Timed Up and Go test, and Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36) were collected before surgery and again at 6 and 12 months after surgery. All participants completed the 12-week program. External rotation ROM as well as extensor and abductor muscle strength significantly improved 6 months after treatment compared with that before treatment (P<.05). Significant improvements were also seen in physical function, role physical, and bodily pain subgroup scores of the SF-36 (P<.05). No serious adverse events occurred. This study demonstrates the feasibility and safety of a multiplex rehabilitation program after MSC transplantation and provides support for further study on the benefits of rehabilitation programs in regenerative medicine. Copyright © 2015 American Congress of Rehabilitation Medicine. Published by Elsevier Inc. All rights reserved.

A prospective protocol for nasopharyngeal carcinoma in children and adolescents: the Italian Rare Tumors in Pediatric Age (TREP) project.

PubMed

Casanova, Michela; Bisogno, Gianni; Gandola, Lorenza; Cecchetto, Giovanni; Di Cataldo, Andrea; Basso, Eleonora; Indolfi, Paolo; D'Angelo, Paolo; Favini, Francesca; Collini, Paola; Potepan, Paolo; Ferrari, Andrea

2012-05-15

Nasopharyngeal carcinoma (NPC) is very rare in childhood. It differs from its adult counterpart in the prevalence of the nonkeratinizing, undifferentiated subtype and by an advanced clinical stage at onset and better chances of survival. The risk of long-term treatment-related toxicity also may be a more important issue in younger individuals. A prospective chemoradiotherapy protocol for pediatric NPC was started in Italy in 2000 within the framework of the Rare Tumors in Pediatric Age (TREP) project. Three courses of cisplatin/5-fluorouracil induction chemotherapy were followed by radiotherapy (doses up to 65 grays) with concomitant cisplatin. Forty-six patients (ages 9-17 years) were considered eligible for the study over a 10-year period. The ratio of observed to expected cases based on epidemiological data was approximately 1 for both children and adolescents. All but 1 patient had lymph node involvement, and 5 patients had distant metastases. The rate of response to primary chemotherapy was 90%. The 5-year overall and progression-free survival rates were 80.9% and 79.3%, respectively (median follow-up, 62 months). The only statistically significant prognostic variable was the presence or absence of distant metastases. A 65% incidence of late sequelae was reported. This study demonstrates the feasibility and efficacy of a prospective protocol even for such rare tumors as pediatric NPC. The use of lower radiotherapy doses than those used in adults did not affect locoregional failure rates. Long-term follow-up will be needed to obtain more information on both survival and treatment sequelae. The next objective will be to establish broader, international prospective cooperation schemes. Copyright © 2011 American Cancer Society.

Morbidity and mortality from a propensity score-matched, prospective cohort study of laparoscopic versus open total gastrectomy for gastric cancer: data from a nationwide web-based database.

PubMed

Etoh, Tsuyoshi; Honda, Michitaka; Kumamaru, Hiraku; Miyata, Hiroaki; Yoshida, Kazuhiro; Kodera, Yasuhiro; Kakeji, Yoshihiro; Inomata, Masafumi; Konno, Hiroyuki; Seto, Yasuyuki; Kitano, Seigo; Hiki, Naoki

2018-06-01

Controversy persists regarding the technical feasibility of laparoscopic total gastrectomy (LTG), and to our knowledge, no prospective study with a sample size sufficient to investigate its safety has been reported. We aimed to compare the postoperative morbidity and mortality rates in patients undergoing LTG and open total gastrectomy (OTG) for gastric cancer in prospectively enrolled cohort using nationwide web-based registry. From August 2014 to July 2015, consecutive patients undergoing LTG or OTG (925 and 1569 patients, respectively) at the participating institutions were enrolled prospectively into the National Clinical Database registration system. We constructed propensity score (PS) models separately in four facility yearly case-volume groups, and evaluated the postoperative morbidity and mortality in PS-matched 1024 patients undergoing LTG or OTG. The incidence of overall morbidity were 84 (16.4%) in the OTG and 54 (10.3%) in the LTG groups (p = 0.01).The incidence of anastomotic leakage and pancreatic fistula grade B or above were not significantly different between the two groups (LTG 5.3% vs. OTG 6.1%, p = 0.59, LTG 2.7% vs. OTG 3.7%, p = 0.38, respectively). There were also no significant differences in the 30-day and in-hospital mortality rates between the two groups (LTG 0.2% vs. OTG 0.4%, p = 0.56; LTG 0.4% vs. OTG 0.4%, p = 1.00, respectively). The results from our nationally representative data analysis showed that LTG could be a safe procedure to treat gastric cancer compared to OTG. The indication for LTG should be considered carefully in a clinical setting.

Development and study of 99mTc-1-Thio-D-glucose for visualization of malignant tumors

NASA Astrophysics Data System (ADS)

Zeltchan, R.; Medvedeva, A.; Sinilkin, I.; Bragina, O.; Chernov, V.; Stasyuk, E.; Rogov, A.; Il'ina, E.; Skuridin, V.

2017-09-01

The preclinical studies of 99mTc-1-Thio-D-glucose, a new tumor-seeking agent based on technetium-99m-labeled glucose derivative, were conducted, and the feasibility of using this radiopharmaceutical for tumor visualization was studied. The preclinical studies were carried out strictly in accordance with the local legislation and were regulated by the generally accepted research standards. 99mTc-1-Thio-D-glucose was found to have optimal pharmacokinetic and physico-chemical properties for diagnostic imaging and was proved to belong to the low-toxic substances. The potential utility of 99mTc-1-thio-D-glucose for tumor imaging was studied in vitro and in vivo models. The present study demonstrated that 99mTc-1-Thio-D-glucose is a prospective radiopharmaceutical for cancer visualization.

Magnetic Resonance Imaging-Guided Transurethral Ultrasound Ablation of Prostate Tissue in Patients with Localized Prostate Cancer: A Prospective Phase 1 Clinical Trial.

PubMed

Chin, Joseph L; Billia, Michele; Relle, James; Roethke, Matthias C; Popeneciu, Ionel V; Kuru, Timur H; Hatiboglu, Gencay; Mueller-Wolf, Maya B; Motsch, Johann; Romagnoli, Cesare; Kassam, Zahra; Harle, Christopher C; Hafron, Jason; Nandalur, Kiran R; Chronik, Blaine A; Burtnyk, Mathieu; Schlemmer, Heinz-Peter; Pahernik, Sascha

2016-09-01

Magnetic resonance imaging-guided transurethral ultrasound ablation (MRI-TULSA) is a novel minimally invasive technology for ablating prostate tissue, potentially offering good disease control of localized cancer and low morbidity. To determine the clinical safety and feasibility of MRI-TULSA for whole-gland prostate ablation in a primary treatment setting of localized prostate cancer (PCa). A single-arm prospective phase 1 study was performed at three tertiary referral centers in Canada, Germany, and the United States. Thirty patients (median age: 69 yr; interquartile range [IQR]: 67-71 yr) with biopsy-proven low-risk (80%) and intermediate-risk (20%) PCa were treated and followed for 12 mo. MRI-TULSA treatment was delivered with the therapeutic intent of conservative whole-gland ablation including 3-mm safety margins and 10% residual viable prostate expected around the capsule. Primary end points were safety (adverse events) and feasibility (technical accuracy and precision of conformal thermal ablation). Exploratory outcomes included quality of life, prostate-specific antigen (PSA), and biopsy at 12 mo. Median treatment time was 36min (IQR: 26-44) and prostate volume was 44ml (IQR: 38-48). Spatial control of thermal ablation was ±1.3mm on MRI thermometry. Common Terminology Criteria for Adverse Events included hematuria (43% grade [G] 1; 6.7% G2), urinary tract infections (33% G2), acute urinary retention (10% G1; 17% G2), and epididymitis (3.3% G3). There were no rectal injuries. Median pretreatment International Prostate Symptom Score 8 (IQR: 5-13) returned to 6 (IQR: 4-10) at 3 mo (mean change: -2; 95% confidence interval [CI], -4 to 1). Median pretreatment International Index of Erectile Function 13 (IQR: 6-28) recovered to 13 (IQR: 5-25) at 12 mo (mean change: -1; 95% CI, -5 to 3). Median PSA decreased 87% at 1 mo and was stable at 0.8 ng/ml (IQR: 0.6-1.1) to 12 mo. Positive biopsies showed 61% reduction in total cancer length, clinically significant disease in 9 of 29 patients (31%; 95% CI, 15-51), and any disease in 16 of 29 patients (55%; 95% CI, 36-74). MRI-TULSA was feasible, safe, and technically precise for whole-gland prostate ablation in patients with localized PCa. Phase 1 data are sufficiently compelling to study MRI-TULSA further in a larger prospective trial with reduced safety margins. We used magnetic resonance imaging-guided transurethral ultrasound to heat and ablate the prostate in men with prostate cancer. We showed that the treatment can be targeted within a narrow range (1mm) and has a well-tolerated side effect profile. A larger study is under way. NCT01686958, DRKS00005311. Copyright © 2016. Published by Elsevier B.V.

High-intensity focused ultrasound (HIFU) for pancreatic carcinoma: evaluation of feasibility, reduction of tumour volume and pain intensity.

PubMed

Marinova, Milka; Rauch, Maximilian; Mücke, Martin; Rolke, Roman; Gonzalez-Carmona, Maria A; Henseler, Jana; Cuhls, Henning; Radbruch, Lukas; Strassburg, Christian P; Zhang, Lian; Schild, Hans H; Strunk, Holger M

2016-11-01

Prognosis of patients with locally advanced pancreatic adenocarcinoma is extremely poor. They often suffer from cancer-related pain reducing their quality of life. This prospective observational study aimed to evaluate feasibility, local tumour response, and changes in quality of life and symptoms in Caucasian patients with locally advanced pancreatic cancer treated by ultrasound-guided high-intensity focused ultrasound (HIFU). Thirteen patients underwent HIFU, five with stage III, eight with stage IV UICC disease. Ten patients received simultaneous palliative chemotherapy. Postinterventional clinical assessment included evaluation of quality of life and symptom changes using standardized questionnaires. CT and MRI follow-up evaluated the local tumour response. HIFU was successfully performed in all patients. Average tumour reduction was 34.2 % at 6 weeks and 63.9 % at 3 months. Complete or partial relief of cancer-related pain was achieved in 10 patients (77 %), five of whom required less analgesics for pain control. Quality of life was improved revealing increased global health status and alleviated symptoms. HIFU treatment was well tolerated. Eight patients experienced transient abdominal pain directly after HIFU. HIFU ablation of pancreatic carcinoma is a feasible, safe and effective treatment with a crucial benefit in terms of reduction of tumour volume and pain intensity. • US-guided HIFU is feasible and safe for patients with unresectable pancreatic cancer. • HIFU can considerably reduce tumour volume and cancer-related pain. • Patients treated with HIFU experienced significant and lasting reduction of pain intensity. • HIFU has a crucial clinical benefit for patients with pancreatic cancer.

Feasibility and preliminary efficacy of a web-based smoking cessation intervention for HIV-infected smokers: a randomized controlled trial.

PubMed

Shuter, Jonathan; Morales, Daniela A; Considine-Dunn, Shannon E; An, Lawrence C; Stanton, Cassandra A

2014-09-01

To evaluate the feasibility and preliminary efficacy of a Web-based tobacco treatment for persons living with HIV (PLWH). Prospective, randomized controlled trial. HIV-care center in the Bronx, New York. Eligibility criteria included HIV infection, current tobacco usage, interest in quitting, and access to a computer with internet. One hundred thirty-eight subjects enrolled, and 134 completed the study. Positively Smoke Free on the Web (PSFW), an 8-session, 7-week targeted tobacco treatment program for PLWH, was compared with standard care (brief advice to quit and self-help brochure). All subjects were offered nicotine patches. The main feasibility outcomes were number of sessions logged into, number of Web pages visited, number of interactive clicks, and total time logged in. The main efficacy outcome was biochemically verified, 7-day point prevalence abstinence 3 months after intervention. PSFW subjects logged into a mean of 5.5 of 8 sessions and 26.2 of 41 pages. They executed a mean of 10 interactive clicks during a mean total of 59.8 minutes logged in. Most required reminder phone calls to complete the sessions. Educational level, anxiety score, and home access of the Web site were associated with Web site usage. Ten percent of the PSFW group vs. 4.3% of controls achieved the abstinence end point. Among those who completed all 8 sessions, 17.9% were abstinent, and among women completers, 30.8% were abstinent. Web-based treatment is a feasible strategy for PLWH smokers, and preliminary findings suggest therapeutic efficacy.

Feasibility of event-related potential (ERP) biomarker use to study effects of mother's voice exposure on speech sound differentiation of preterm infants.

PubMed

D Chorna, Olena; L Hamm, Ellyn; Shrivastava, Hemang; Maitre, Nathalie L

2018-01-01

Atypical maturation of auditory neural processing contributes to preterm-born infants' language delays. Event-related potential (ERP) measurement of speech-sound differentiation might fill a gap in treatment-response biomarkers to auditory interventions. We evaluated whether these markers could measure treatment effects in a quasi-randomized prospective study. Hospitalized preterm infants in passive or active, suck-contingent mother's voice exposure groups were not different at baseline. Post-intervention, the active group had greater increases in/du/-/gu/differentiation in left frontal and temporal regions. Infants with brain injury had lower baseline/ba/-/ga/and/du/-/gu/differentiation than those without. ERP provides valid discriminative, responsive, and predictive biomarkers of infant speech-sound differentiation.

Quality Indexes and Feasibility Analysis of Traditional Dried Anchovy From Buru Island

NASA Astrophysics Data System (ADS)

Krisanta Enda Savitri, Imelda; Sormin, R. B. D.; Silaban, Bernita

2017-10-01

Dried anchovy is a prominent fishery product in Buru Island Maluku. It is produce traditionally in villages Batuboi and Siahoni at Kayeli bay. Drying process was done in open air under the sun directly during two days to produce dried anchovy with a prospective marketable. This preliminary research was aimed to investigated the quality indexes and business feasibility of dried anchovy produced by processor comunity. The quality index was found by laboratory analysis of sample dried anchovy referring to Indonesian National Standard. The data for feasibility analysis was found by interview and by using quesioner list. The average Quality indexes of dried anchovy as follows: Water 14.22 grams percent; Protein 55.68 grams percent; Fat 2.29 grams percent; Ash 9.02 grams percent; Total Bacteri (TPC) 3,5 × 102-; organoleptic value 7.79; E. coli, Salmonella and Mold were unidentified. Total cost of dried anchovy production is 37,050,720 Rupiahs/year with the income was 224,000,000 Rupiahs/year. Total profit is 217,824,880 Rupiahs/year and the Revenue Cost ratio was 6.05. Dried anchovy from Buru Island has a good quality and also has a good business feasibility.

Feasibility of studying brain morphology in major depressive disorder with structural magnetic resonance imaging and clinical data from the electronic medical record: A pilot study

PubMed Central

Hoogenboom, Wouter S.; Perlis, Roy H.; Smoller, Jordan W.; Zeng-Treitler, Qing; Gainer, Vivian S.; Murphy, Shawn N.; Churchill, Susanne E.; Kohane, Isaac S.; Shenton, Martha E.; Iosifescu, Dan V.

2012-01-01

For certain research questions related to long-term outcomes or to rare disorders, designing prospective studies is impractical or prohibitively expensive. Such studies could instead utilize clinical and magnetic resonance imaging data (MRI) collected as part of routine clinical care, stored in the electronic medical record (EMR). Using major depressive disorder (MDD) as a disease model, we examined the feasibility of studying brain morphology and associations with remission using clinical and MRI data exclusively drawn from the EMR. Advanced automated tools were used to select MDD patients and controls from the EMR who had brain MRI data, but no diagnosed brain pathology. MDD patients were further assessed for remission status by review of clinical charts. Twenty MDD patients (eight full-remitters, six partial-remitters, and six non-remitters), and fifteen healthy control subjects met all study criteria for advanced morphometric analyses. Compared to controls, MDD patients had significantly smaller right rostral-anterior cingulate volume, and level of non-remission was associated with smaller left hippocampus and left rostral-middle frontal gyrus volume. The use of EMR data for psychiatric research may provide a timely and cost-effective approach with the potential to generate large study samples reflective of the real population with the illness studied. PMID:23149041

IT-based Psychosocial Distress Screening in Patients with Sarcoma and Parental Caregivers via Disease-specific Online Social Media Communities.

PubMed

Pohlig, Florian; Lenze, Ulrich; Muhlhofer, Heinrich M L; Lenze, Florian W; Schauwecker, Johannes; Knebel, Carolin; Zimmermann, Tanja; Herschbach, Peter

2017-01-01

Psychosocial distress can be frequently observed in patients with sarcoma, depicting a relevant clinical problem. However, prospective data collection on psychosocial distress in patients with rare tumors is often time-consuming. In this context, social media such as Facebook can serve as a potential platform to expand research. The aim of this study was to assess the feasibility of psychosocial distress screening in patients with osteosarcoma and Ewing's sarcoma via social media. For this study an online questionnaire including general information and self-assessment distress measurement tools for patients and parents was created. The link to the questionnaire was then posted on the main page of the two largest disease-specific Facebook communities on osteosarcoma and Ewing's sarcoma. Within 2 months, 28 patients and 58 parents of patients were enrolled. All patients with osteosarcoma and Ewing's sarcoma, as well as the majority of parental caregivers of such patients, showed relevant psychosocial distress levels. Crowdsourcing via disease-specific patient communities on Facebook is feasible and provides great potential for acquisition of medical data of rare diseases. Copyright© 2017, International Institute of Anticancer Research (Dr. George J. Delinasios), All rights reserved.

Hyperspectral imaging for detection of arthritis: feasibility and prospects

NASA Astrophysics Data System (ADS)

Milanic, Matija; Paluchowski, Lukasz A.; Randeberg, Lise L.

2015-09-01

Rheumatoid arthritis (RA) is a disease that frequently leads to joint destruction. It has a high incidence rate worldwide, and the disease significantly reduces patients' quality of life. Detecting and treating inflammatory arthritis before structural damage to the joint has occurred is known to be essential for preventing patient disability and pain. Existing diagnostic technologies are expensive, time consuming, and require trained personnel to collect and interpret data. Optical techniques might be a fast, noninvasive alternative. Hyperspectral imaging (HSI) is a noncontact optical technique which provides both spectral and spatial information in one measurement. In this study, the feasibility of HSI in arthritis diagnostics was explored by numerical simulations and optimal imaging parameters were identified. Hyperspectral reflectance and transmission images of RA and normal human joint models were simulated using the Monte Carlo method. The spectral range was 600 to 1100 nm. Characteristic spatial patterns for RA joints and two spectral windows with transmission were identified. The study demonstrated that transmittance images of human joints could be used as one parameter for discrimination between arthritic and unaffected joints. The presented work shows that HSI is a promising imaging modality for the diagnostics and follow-up monitoring of arthritis in small joints.

Feasibility study on introduction of the bio-fuel power generation in tropical regions

NASA Astrophysics Data System (ADS)

1993-03-01

Study is made on feasibility of introducing the bio-fuel power generation in tropical regions, especially in South East Asia including Okinawa and South America. Biomass promising as bio-fuel is bagasse and palm oil mill dregs; and bagasse is found to be advantageous to the use for large-scaled power generation. Prospective uses of bagasse are a combined use of gasification process and gas turbine power generation, an effective use of gas turbine exhaust heat at sugar cane factories, and a use of the system to be developed which totalizes these two. As to how to carry out the R and D project, since the gasification power generation process itself is a high technology and has partially unknown fields, it is desirable that research and development are conducted in such technologically developed countries as Japan (Okinawa). A developmental plan, therefore, is worked out as such that a pilot plant of approximately 3000kW is to be constructed in Okinawa because the period for bagasse production is at least 3 months there, and a commercial-scale plant is to be constructed and operated in such big bagasse-producing countries as Brazil.

Telemedicine-guided education on secondary stroke and fall prevention following inpatient rehabilitation for Texas patients with stroke and their caregivers: a feasibility pilot study.

PubMed

Jhaveri, Mansi M; Benjamin-Garner, Ruby; Rianon, Nahid; Sherer, Mark; Francisco, Gerard; Vahidy, Farhaan; Kobayashi, Kayta; Gaber, Mary; Shoemake, Paige; Vu, Kim; Trevino, Alyssa; Grotta, James; Savitz, Sean

2017-09-03

The aftermath of stroke leaves many consequences including cognitive deficits and falls due to imbalance. Stroke survivors and families struggle to navigate the complex healthcare system with little assistance posthospital discharge, often leading to early hospital readmission and worse stroke outcomes. Telemedicine Guided Education on Secondary Stroke and Fall Prevention Following Inpatient Rehabilitation feasibility study examines whether stroke survivors and their caregivers find value in telerehabilitation (TR) home visits that provide individualised care and education by a multidisciplinary team after discharge from inpatient rehabilitation. A prospective, single arm, pilot study is designed to evaluate the feasibility of weekly TR home visits initiated postdischarge from inpatient rehabilitation. Newly diagnosed patients with stroke are recruited from a Houston-based comprehensive stroke centre inpatient rehabilitation unit, loaned an iPad with data plan and trained to use information technology security-approved videoconferencing application. After hospital discharge, six weekly TR home visits are led by rotating specialists (pharmacist, physical/occupational therapist, speech therapist, rehabilitation physician, social worker, geriatrician specialised in fracture prevention) followed by satisfaction survey on week 7. Specialists visually assess patients in real time, educate them on secondary stroke and fall prevention and suggest ways to improve function including direct medical interventions when indicated. Primary outcomes are proportion of eligible patients consenting to the study, participation rate in all six TR home visits and satisfaction score. The study started 31 December 2015 with plan to enrol up to 50 patients over 24 months. Feasibility study results will inform us as to whether a randomised controlled trial is warranted to determine efficacy of TR home visit intervention in improving stroke outcomes. Ethics approval obtained by the Institutional Review Board (IRB), Committee for the Protection of Human Subjects, IRB number: HSC-MS-14-0994. Study results will be submitted for publication in a peer-reviewed journal. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Evaluating the Minimal Specimens From Endoscopic Ultrasound-Guided Fine-Needle Aspiration in Pancreatic Masses

PubMed Central

Park, Joo Kyung; Kang, Ki Joo; Oh, Cho Rong; Lee, Jong Kyun; Lee, Kyu Taek; Jang, Kee Taek; Park, Sang-Mo; Lee, Kwang Hyuck

2016-01-01

Abstract Endoscopic ultrasound-guided fine-needle aspiration (EUS-FNA) has become one of the most useful diagnostic modalities for the diagnosis of pancreatic mass. The aim of this study was to investigate the role of analyzing the minimal specimens obtained by EUS-FNA for the diagnosis of solid masses of pancreas. This study consisted of retrospective and prospective analyses. The retrospective study was performed on 116 patients who underwent EUS-FNA of solid masses for cytological smear, histological analysis, and combined analysis including immunohistochemical (IHC) staining. In the prospective study, 79 patients were enrolled to evaluate the quality and accuracy of EUS-FNA histological analysis and feasibility of IHC staining. The final diagnoses of all patients included pancreatic cancer (n = 126), nonpancreatic cancer (n = 21), other neoplasm (n = 27), and benign lesions (n = 21). In our retrospective study, the combined analysis was more sensitive than cytological analysis alone (P < 0.01). The overall sensitivity of cytology, histology, and combined analysis was 69.8%, 67.2%, and 81.8%, respectively. In the prospective analysis, 64.2% of all punctures were helpful for determining the diagnosis and 40.7% provided sufficient tissue for IHC staining. Histological analysis was helpful for diagnosis in 74.7% of patients. IHC staining was necessary for a definite diagnosis in 11.4% of patients, especially in the cases of nonmalignant pancreatic mass. Histological analysis and IHC study of EUS-FNA specimens was useful for the accurate diagnosis of pancreatic and peripancreatic lesions. Combined analysis showed significantly higher sensitivity than cytology alone because IHC staining was helpful for a diagnosis in some patients. PMID:27227937

Feasibility study of the RenalGuard™ balanced hydration system: a novel strategy for the prevention of contrast-induced nephropathy in high risk patients.

PubMed

Dorval, Jean-Francois; Dixon, Simon R; Zelman, Richard B; Davidson, Charles J; Rudko, Robert; Resnic, Frederic S

2013-06-20

Contrast-induced nephropathy (CIN) is a frequent complication following angiographic procedures with significant impact on healthcare costs, and long-term outcomes. Multiple reno-protective strategies have been studied but few have shown benefit in prospective randomized studies beyond limiting the exposure to iodinated contrast and adequate intravenous. We studied the performance and safety of a novel system designed to achieve precise real-time high volume fluid balance using a closed loop hydration monitoring and infusion system. This prospective, multi-center, FDA approved phase II feasibility study was designed to evaluate the safety and the performance of the RenalGuard matched hydration system. Between October 2006 and November 2007, twenty-three subjects at high risk for CIN (with an estimated glomerular filtration rate (eGFR)<50ml/min/1.73m(2)) undergoing diagnostic or therapeutic catheterization were treated with the system. The primary endpoint of the study was defined as the ability of the system to effectively dynamically match fluid administration to urine output. The 23 subjects at high risk for CIN enrolled had a mean±SD eGFR of 39±9.3. Patients achieved an hourly urine flow rate of 620±400ml/h. The system had a mean effectiveness rate of 99.9% over the duration of therapy with an average saline volume infused of 3825ml closely matched, minute to minute, to urine output of 3579ml. There were no major device-related complications from the experimental therapy, though one patient developed hypokalemia requiring replacement. Two subjects (9.5%) developed CIN as defined by >0.5mg/dl or >25% rise in serum creatinine at 48-60h post contrast administration when compared with the baseline. The study confirmed that the RenalGuard(TM) system is safe and dynamically balances volume hydration with urine production. Further randomized studies are needed to confirm the efficacy of the system in reducing the incidence of CIN. Copyright © 2011 Elsevier Ireland Ltd. All rights reserved.

Feasibility and effectiveness of the implementation of a primary prevention programme for type 2 diabetes in routine primary care practice: a phase IV cluster randomised clinical trial

PubMed Central

2012-01-01

Background The objective of this study is to perform an independent evaluation of the feasibility and effectiveness of an educational programme for the primary prevention of type 2 diabetes (DM2) in high risk populations in primary care settings, implanted within the Basque Health Service - Osakidetza. Methods/design This is a prospective phase IV cluster clinical trial conducted under routine conditions in 14 primary health care centres of Osakidetza, randomly assigned to an intervention or control group. We will recruit a total sample of 1089 individuals, aged between 45 and 70 years old, without diabetes but at high risk of developing the condition (Finnish Diabetes Risk Score, FINDRISC ≥ 14) and follow them up for 2 years. Primary health care nursing teams of the intervention centres will implement DE-PLAN, a structured educational intervention program focused on changing healthy lifestyles (diet and physical activity); while the patients in the control centres will receive the usual care for the prevention and treatment of DM2 currently provided in Osakidetza. The effectiveness attributable to the programme will be assessed by comparing the changes observed in patients exposed to the intervention and those in the control group, with respect to the risk of developing DM2 and lifestyle habits. In terms of feasibility, we will assess indicators of population coverage and programme implementation. Discussion The aim of this study is to provide the scientific basis for disseminate the programme to the remaining primary health centres in Osakidetza, as a novel way of addressing prevention of DM2. The study design will enable us to gather information on the effectiveness of the intervention as well as the feasibility of implementing it in routine practice. Trial registration ClinicalTrials.gov NCT01365013 PMID:23158830

Kinect-based choice reaching and stepping reaction time tests for clinical and in-home assessment of fall risk in older people: a prospective study.

PubMed

Ejupi, Andreas; Gschwind, Yves J; Brodie, Matthew; Zagler, Wolfgang L; Lord, Stephen R; Delbaere, Kim

2016-01-01

Quick protective reactions such as reaching or stepping are important to avoid a fall or minimize injuries. We developed Kinect-based choice reaching and stepping reaction time tests (Kinect-based CRTs) and evaluated their ability to differentiate between older fallers and non-fallers and the feasibility of administering them at home. A total of 94 community-dwelling older people were assessed on the Kinect-based CRTs in the laboratory and were followed-up for falls for 6 months. Additionally, a subgroup (n = 20) conducted the Kinect-based CRTs at home. Signal processing algorithms were developed to extract features for reaction, movement and the total time from the Kinect skeleton data. Nineteen participants (20.2 %) reported a fall in the 6 months following the assessment. The reaction time (fallers: 797 ± 136 ms, non-fallers: 714 ± 89 ms), movement time (fallers: 392 ± 50 ms, non-fallers: 358 ± 51 ms) and total time (fallers: 1189 ± 170 ms, non-fallers: 1072 ± 109 ms) of the reaching reaction time test differentiated well between the fallers and non-fallers. The stepping reaction time test did not significantly discriminate between the two groups in the prospective study. The correlations between the laboratory and in-home assessments were 0.689 for the reaching reaction time and 0.860 for stepping reaction time. The study findings indicate that the Kinect-based CRT tests are feasible to administer in clinical and in-home settings, and thus represents an important step towards the development of sensor-based fall risk self-assessments. With further validation, the assessments may prove useful as a fall risk screen and home-based assessment measures for monitoring changes over time and effects of fall prevention interventions.

Prospective single-arm study of intraoperative radiotherapy for locally advanced or recurrent rectal cancer.

PubMed

Tan, Jennifer; Heriot, Alexander G; Mackay, Jack; Van Dyk, Sylvia; Bressel, Mathias Ab; Fox, Chris D; Hui, Andrew C; Lynch, A Craig; Leong, Trevor; Ngan, Samuel Y

2013-10-01

This study aims to evaluate the feasibility and outcomes of intraoperative radiotherapy (IORT) using high-dose-rate (HDR) brachytherapy for locally advanced or recurrent rectal cancers. Despite preoperative chemoradiation, patients with locally advanced or recurrent rectal cancers undergoing surgery remain at high risk of local recurrence. Intensification of radiation with IORT may improve local control. This is a prospective non-randomised study. Eligible patients were those with T4 rectal cancer or pelvic recurrence, deemed suitable for radical surgery but at high risk of positive resection margins, without evidence of metastasis. Chemoradiation was followed by radical surgery. Ten gray (Gy) was delivered to tumour bed via an IORT applicator at time of surgery. There were 15% primary and 85% recurrent cancers. The 71% received preoperative chemoradiation. R0, R1 and R2 resections were 70%, 22% and 7%, respectively. IORT was successfully delivered in 27 of 30 registered patients (90% (95% confidence interval (CI) = 73-98) ) at a median reported time of 12 weeks (interquartile range (IQR) = 10-16) after chemoradiation. Mean IORT procedure and delivery times were 63 minutes (range 22-105 minutes). Ten patients (37% (95% CI = 19-58) ) experienced grade 3 or 4 toxicities (three wound, four abscesses, three soft tissue, three bowel obstructions, three ureteric obstructions and two sensory neuropathies). Local recurrence-free, failure-free and overall survival rates at 2.5 years were 68% (95% CI = 52-89), 37% (95% CI = 23-61) and 82% (95% CI = 68-98), respectively. The addition of IORT to radical surgery for T4 or recurrent rectal cancer is feasible. It can be delivered safely with low morbidity and good tumour outcomes. © 2013 The Authors. Journal of Medical Imaging and Radiation Oncology © 2013 The Royal Australian and New Zealand College of Radiologists.

Serotonin Receptors in the Medulla Oblongata of the Human Fetus and Infant: The Analytic Approach of the International Safe Passage Study

PubMed Central

Folkerth, Rebecca D.; Paterson, David S.; Broadbelt, Kevin G.; Dan Zaharie, S.; Hewlett, Richard H.; Dempers, Johan J.; Burger, Elsie; Wadee, Shabbir; Schubert, Pawel; Wright, Colleen; Sens, Mary Ann; Nelsen, Laura; Randall, Bradley B.; Tran, Hoa; Geldenhuys, Elaine; Elliott, Amy J.; Odendaal, Hein J.; Kinney, Hannah C.

2016-01-01

The Safe Passage Study is an international, prospective study of approximately 12 000 pregnancies to determine the effects of prenatal alcohol exposure (PAE) upon stillbirth and the sudden infant death syndrome (SIDS). A key objective of the study is to elucidate adverse effects of PAE upon binding to serotonin (5-HT) 1A receptors in brainstem homeostatic networks postulated to be abnormal in unexplained stillbirth and/or SIDS. We undertook a feasibility assessment of 5-HT1A receptor binding using autoradiography in the medulla oblongata (6 nuclei in 27 cases). 5-HT1A binding was compared to a reference dataset from the San Diego medical examiner’s system. There was no adverse effect of postmortem interval ≤100 h. The distribution and quantitated values of 5-HT1A binding in Safe Passage Study cases were essentially identical to those in the reference dataset, and virtually identical between stillbirths and live born fetal cases in grossly non-macerated tissues. The pattern of binding was present at mid-gestation with dramatic changes in binding levels in the medullary 5-HT nuclei over the second half of gestation; there was a plateau at lower levels in the neonatal period and into infancy. This study demonstrates feasibility of 5-HT1A binding analysis in the medulla in the Safe Passage Study. PMID:27634962

Progressive resistance training in head and neck cancer patients undergoing concomitant chemoradiotherapy

PubMed Central

Lonkvist, Camilla K.; Vinther, Anders; Zerahn, Bo; Rosenbom, Eva; Deshmukh, Atul S.; Hojman, Pernille

2017-01-01

Objectives Patients with head and neck squamous cell carcinoma undergoing concomitant chemoradiotherapy (CCRT) frequently experience weight loss, especially loss of lean body mass (LBM), and reduced functional performance. This study investigated whether a 12‐week hospital‐based progressive resistance training (PRT) program during CCRT is feasible in the clinical setting before planning initiation of a larger randomized study which is the long‐term goal. Study design Prospective pilot study. Methods Twelve patients receiving CCRT were planned to attend a 12‐week PRT program. Primary endpoint was feasibility measured as attendance to training sessions. Secondary endpoints included changes in functional performance, muscle strength, and body composition measured by Dual‐energy X‐ray Absorptiometry (DXA) scans. Furthermore, sarcomeric protein content, pentose phosphate pathway (PPP) activity, and glycolysis were determined in muscle biopsies. Results Twelve patients with p16 positive oropharyngeal cancer were enrolled. The primary endpoint was met with 9 of the 12 patients completing at least 25 of 36 planned training sessions. The mean attendance rate was 77%. Functional performance was maintained during the treatment period and increased during follow‐up (p < 0.01). Strength was regained after an initial dip during treatment, paralleling responses in LBM and sarcomeric protein content. LBM began to increase immediately after treatment. The PPP was upregulated after the treatment period, whilst glycolysis remained unchanged. No adverse events were related to PRT and in questionnaires, patients emphasized the social and psychological benefits of attendance. Conclusion Progressive resistance training is feasible and safe during CCRT for head and neck cancer, and is associated with high patient satisfaction. Level of Evidence 2C. PMID:29094074

Feasibility and Acceptability of Mobile Epilepsy Educational System (MEES) for People with Epilepsy in Malaysia

PubMed Central

Neni, Widiasmoro Selamat

2012-01-01

Abstract Background: Telemedicine innovations, including short message service (SMS), have been used to address a range of health concerns in a variety of settings. Practical, safe, and cost-effective, this simple tool can also potentially improve patients' understanding toward their own diseases via knowledge enhancement. This study was designed to develop and assess the feasibility and acceptability of an SMS-based epilepsy educational program for epilepsy patients. Subjects and Methods: This was a prospective randomized interventional study. Epilepsy outpatients from three general hospitals in East Coast Peninsular Malaysia received the SMS-based mobile epilepsy educational system (MEES) for a 3-month period. Results: In total, 51 patients completed the study (median age, 25.0 years; 51.0% female; 92.2% Malay; 56.9% single; education level, 70.6% ≤SPM/Cambridge O-level equivalent; 25.5% supportive workers; monthly income, 58.8% ≤MYR 500.0/USD 158.5). Approximately 86.0% of the patients owned at least a mobile phone. The total cost of SMS delivery was economically affordable (MYR 3.08/USD 0.98 per patient). Overall, 74.0% agreed that MEES was either very or quite useful. It is encouraging that the majority of patients have offered positive comments and favorable opinions specifically toward epilepsy education (94.0%), drug-taking reminder (90.0%), and clinic appointment reminder (88.0%). It was also reported that 88.2% of the participants would recommend MEES to other people with epilepsy. Conclusions: The current study adds to the growing evidence suggesting that a greater investment in telemedicine programs involving SMS would be both feasible and well received by patients and could be a potentially valuable approach to increase access and effectiveness of epilepsy care. PMID:23078181

Feasibility and acceptability of mobile epilepsy educational system (MEES) for people with epilepsy in Malaysia.

PubMed

Lua, Pei Lin; Neni, Widiasmoro Selamat

2012-12-01

Telemedicine innovations, including short message service (SMS), have been used to address a range of health concerns in a variety of settings. Practical, safe, and cost-effective, this simple tool can also potentially improve patients' understanding toward their own diseases via knowledge enhancement. This study was designed to develop and assess the feasibility and acceptability of an SMS-based epilepsy educational program for epilepsy patients. This was a prospective randomized interventional study. Epilepsy outpatients from three general hospitals in East Coast Peninsular Malaysia received the SMS-based mobile epilepsy educational system (MEES) for a 3-month period. In total, 51 patients completed the study (median age, 25.0 years; 51.0% female; 92.2% Malay; 56.9% single; education level, 70.6% ≤SPM/Cambridge O-level equivalent; 25.5% supportive workers; monthly income, 58.8% ≤MYR 500.0/USD 158.5). Approximately 86.0% of the patients owned at least a mobile phone. The total cost of SMS delivery was economically affordable (MYR 3.08/USD 0.98 per patient). Overall, 74.0% agreed that MEES was either very or quite useful. It is encouraging that the majority of patients have offered positive comments and favorable opinions specifically toward epilepsy education (94.0%), drug-taking reminder (90.0%), and clinic appointment reminder (88.0%). It was also reported that 88.2% of the participants would recommend MEES to other people with epilepsy. The current study adds to the growing evidence suggesting that a greater investment in telemedicine programs involving SMS would be both feasible and well received by patients and could be a potentially valuable approach to increase access and effectiveness of epilepsy care.

Is 2D speckle tracking echocardiography useful for detecting and monitoring myocardial dysfunction in adult m.3243A>G carriers? - a retrospective pilot study.

PubMed

Koene, S; Timmermans, J; Weijers, G; de Laat, P; de Korte, C L; Smeitink, J A M; Janssen, M C H; Kapusta, L

2017-03-01

Cardiomyopathy is a common complication of mitochondrial disorders, associated with increased mortality. Two dimensional speckle tracking echocardiography (2DSTE) can be used to quantify myocardial deformation. Here, we aimed to determine the usefulness of 2DSTE in detecting and monitoring subtle changes in myocardial dysfunction in carriers of the 3243A>G mutation in mitochondrial DNA. In this retrospective pilot study, 30 symptomatic and asymptomatic carriers of the mitochondrial 3243A>G mutation of whom two subsequent echocardiograms were available were included. We measured longitudinal, circumferential and radial strain using 2DSTE. Results were compared to published reference values. Speckle tracking was feasible in 90 % of the patients for longitudinal strain. Circumferential and radial strain showed low face validity (low number of images with sufficient quality; suboptimal tracking) and were therefore rejected for further analysis. Global longitudinal strain showed good face validity, and was abnormal in 56-70 % (depending on reference values used) of the carriers (n = 27). Reproducibility was good (mean difference of 0.83 for inter- and 0.40 for intra-rater reproducibility; ICC 0.78 and 0.89, respectively). The difference between the first and the second measurement exceeded the measurement variance in 39 % of the cases (n = 23; feasibility of follow-up 77 %). Even in data collected as part of clinical care, two-dimensional strain echocardiography seems a feasible method to detect and monitor subtle changes in longitudinal myocardial deformation in adult carriers of the mitochondrial 3243A>G mutation. Based on our data and the reported accuracy of global longitudinal strain in other studies, we suggest the use of global longitudinal strain in a prospective follow-up or intervention study.

DOE Office of Scientific and Technical Information (OSTI.GOV)

Dorenberg, Eric J., E-mail: eric.dorenberg@rikshospitalet.no; Jakobsen, Jarl A.; Brabrand, Knut

Purpose. To evaluate the feasibility of using contrast-enhanced ultrasound (CEUS) during uterine artery embolization (UAE) in order to define the correct end-point of embolization with complete devascularization of all fibroids. Methods. In this prospective study of 10 consecutive women undergoing UAE, CEUS was performed in the angiographic suite during embolization. When the angiographic end-point, defined as the 'pruned-tree' appearance of the uterine arteries was reached, CEUS was performed while the angiographic catheters to both uterine arteries were kept in place. The decision whether or not to continue the embolization was based on the findings at CEUS. The results of CEUSmore » were compared with those of contrast-enhanced magnetic resonance imaging (MRI) 1 day as well as 3 months following UAE. Results. CEUS was successfully performed in all women. In 4 cases injection of particles was continued based on the findings at CEUS despite angiographically complete embolization. CEUS imaging at completion of UAE correlated well with the findings at MRI. Conclusion. The use of CEUS during UAE is feasible and may increase the quality of UAE.« less

Research on advanced transportation systems

NASA Astrophysics Data System (ADS)

Nagai, Hirokazu; Hashimoto, Ryouhei; Nosaka, Masataka; Koyari, Yukio; Yamada, Yoshio; Noda, Keiichirou; Shinohara, Suetsugu; Itou, Tetsuichi; Etou, Takao; Kaneko, Yutaka

1992-08-01

An overview of the researches on advanced space transportation systems is presented. Conceptual study is conducted on fly back boosters with expendable upper stage rocket systems assuming a launch capacity of 30 tons and returning to the launch site by the boosters, and prospect of their feasibility is obtained. Reviews are conducted on subjects as follows: (1) trial production of 10 tons sub scale engines for the purpose of acquiring hardware data and picking up technical problems for full scale 100 tons thrust engines using hydrocarbon fuels; (2) development techniques for advanced liquid propulsion systems from the aspects of development schedule, cost; (3) review of conventional technologies, and common use of component; (4) oxidant switching propulsion systems focusing on feasibility of Liquefied Air Cycle Engine (LACE) and Compressed Air Cycle Engine (CACE); (5) present status of slosh hydrogen manufacturing, storage, and handling; (6) construction of small high speed dynamometer for promoting research on mini pump development; (7) hybrid solid boosters under research all over the world as low-cost and clean propulsion systems; and (8) high performance solid propellant for upper stage and lower stage propulsion systems.

Prospects for a Muon Spin Resonance Facility in the Fermilab MuCool Test Area

DOE Office of Scientific and Technical Information (OSTI.GOV)

Johnstone, John A.; Johnstone, Carol

This paper investigates the feasibility of re-purposing the MuCool Test Area (MTA) beamline and experimental hall to support a Muon Spin Resonance (MuSR) facility, which would make it the only such facility in the US. This report reviews the basic muon production concepts studied and operationally implemented at TRIUMF, PSI, and RAL and their application in the context of the MTA facility. Two scenarios were determined feasible. One, an initial minimal-shielding and capital-cost investment stage with a single secondary muon beamline that utilizes an existing high- intensity beam absorber and, another, upgraded stage, that implements an optimized production target pile,more » a proximate high-intensity absorber, and optimized secondary muon lines. A unique approach is proposed which chops or strips a macropulse of H$^-$ beam into a micropulse substructure – a muon creation timing scheme – which allows Muon Spin Resonance experiments in a linac environment. With this timing scheme, and attention to target design and secondary beam collection, the MTA can host enabling and competitive Muon Spin Resonance experiments.« less

Development and validation of a questionnaire to measure preferences and expectations of patients undergoing palliative chemotherapy: EXPECT questionnaire.

PubMed

Patil, V M; Chakraborty, S; Jithin, T K; Dessai, S; Sajith Babu, T P; Raghavan, V; Geetha, M; Kumar, T Shiva; Biji, M S; Bhattacharjee, A; Nair, C

2016-01-01

The objective was to design and validate the questionnaire for capturing palliative chemotherapy-related preferences and expectations. Single arm, unicentric, prospective observational study. EXPECT questionnaire was designed to capture preferences and expectations of patients undergoing palliative chemotherapy. This questionnaire underwent a linguistic validation and then was tested in patients. Ten patients are undergoing chemotherapy for solid tumors who fulfilled the inclusion and exclusion criteria self-administered the EXPECT questionnaire in regional language. After filling this questionnaire, they self-administered quick questionnaire-10 (QQ-10). SPSS version 16 (IBM New York) was used for analysis. Completion rate of EXPECT questionnaire was calculated. The feasibility, face validity, utility and time taken for completion of EXPECT questionnaire was also assessed. The completion rate of this questionnaire was 100%. All patients completed questionnaire within 5 min. The QQ-10 tool confirmed the feasibility, face validity and utility of the questionnaire. EXPECT questionnaire was validated in the regional language, and it's an effective tool for capturing patient's preferences and expectation from chemotherapy.

[Per partum acidosis: Interest and feasibility of cerebral Doppler during labor].

PubMed

Barrois, M; Chartier, M; Lecarpentier, E; Goffinet, F; Tsatsaris, V

2016-09-01

To evaluate feasibility and interest of fetal cerebral Doppler during labor and the link with fetal pH to predict perinatal fetal asphyxia. Our prospective study in a university perinatal center, included patients during labor. There were no risk factors during pregnancy and patients were included after 37 weeks of pregnancy. For each patient an ultrasound with cerebral Doppler was done concomitant to a fetal scalp blood sample. We collected maternal and fetal characteristics as well as cervix dilatation, fetal heart rate analysis and fetal presentation. Among 49 patients included over a period of 4 months, cerebral Doppler failed in 7 cases (11%). Majority of failure occurred at 10cm of dilatation (P=0.007, OR=14.1 [1.483; 709.1275]). Others factors like: maternal age, body mass index, parity, history of C-Section were not associated with higher rate of failure. We did not found either significant correlation between cerebral fetal Doppler and pH on fetal scalp blood sample (r=0.15) nor pH at cord blood sample (r=0.13). No threshold of cerebral Doppler is significant for fetal asphyxia prediction. Fetal cerebral Doppler is feasible during labor with a low rate of failure but not a good exam to predict fetal acidosis and asphyxia. Copyright © 2016 Elsevier Masson SAS. All rights reserved.

Feasibility of a novel low-volume and sodium phosphate-free bowel preparation regimen for colon capsule endoscopy.

PubMed

Zhou, Jieqiong; Tang, Xiaowei; Wang, Jing; Chen, Zhenyu; Wang, Xinying; Jiang, Bo

2017-08-01

Bowel preparation regimens for colon capsule endoscopy are not yet standardized since they are not well optimized. The aim of the present study was to evaluate the feasibility of a novel low-volume and sodium phosphate-free bowel preparation regimen for colon capsule endoscopy. A total of 31 patients were prospectively enrolled. In the novel regimen, on the day prior to examination, a low-fiber diet was permitted, 5 mg mosapride citrate was administered twice (1 h prior to lunch and supper) and 1 l polyethylene glycol was administered in the evening. On the day of the examination, an additional 1 l polyethylene glycol, 5 mg mosapride citrate and 200 mg simethicone were administered before capsule ingestion. Polyethylene glycol booster (0.5 l) was administered twice, at 1 and 4 h following capsule ingestion. Colon cleansing levels, ileocecal valve transit time and completion rate were evaluated. A total of 29 patients were included in the final analysis, 90% of whom achieved adequate preparation of the overall colon. Ileocecal valve transit time was 2.35±0.82 h and completion rate was 79.3%. The results revealed that the novel low-volume and sodium phosphate-free bowel preparation regimen for colon capsule endoscopy was feasible, with adequate colon cleansing and completion rates, and has the potential to be used as an alternative regimen.

Feasibility of Implementing a Comprehensive Warfarin Pharmacogenetics Service

PubMed Central

Nutescu, Edith A.; Drozda, Katarzyna; Bress, Adam P.; Galanter, William L.; Stevenson, James; Stamos, Thomas D.; Desai, Ankit A.; Duarte, Julio D.; Gordeuk, Victor; Peace, David; Kadkol, ShriHari S.; Dodge, Carol; Saraf, Santosh; Garofalo, John; Krishnan, Jerry A.; Garcia, Joe G.N.; Cavallari, Larisa H.

2013-01-01

Objective To determine the procedural feasibility of a pharmacist-led interdisciplinary service for providing genotype-guided warfarin dosing for hospitalized patients newly starting warfarin. Design Prospective observational study Setting 483-bed hospital affiliated with a large academic institution Participants Eighty patients started on warfarin and managed by a newly implemented pharmacogenetics service. Intervention Routine warfarin genotyping and clinical pharmacogenetics consultation Measurements and Main Results The primary outcomes were percent of genotype-guided dose recommendations available prior to the second warfarin dose and adherence of the medical staff to doses recommended by the pharmacogenetics service. Of 436 genotype orders during the first 6 months of the service, 190 were deemed appropriate. For 80 patients on the service who consented to data collection, 77% of genotypes were available prior to the second warfarin dose. The median (range) time from the genotype order to the genotype result was 26 (7 to 80) hours, and the time to genotype-guided dosing recommendation was 30 (7 to 80) hours. Seventy-three percent of warfarin doses ordered by the medical staff were within 0.5 mg of the dose recommended by the pharmacogenetics consult service. Conclusions Providing routine genotype-guided warfarin dosing supported by a pharmacogenetics consult service is feasible from a procedural standpoint, with the majority of genotypes available prior to the second warfarin dose and good adherence to genotype-guided dose recommendations by the medical staff. PMID:23864527

Spontaneous Coronary Artery Dissection: A Disease-Specific, Social Networking Community–Initiated Study

PubMed Central

Tweet, Marysia S.; Gulati, Rajiv; Aase, Lee A.; Hayes, Sharonne N.

2011-01-01

OBJECTIVE: To develop and assess the feasibility of a novel method for identification, recruitment, and retrospective and prospective evaluation of patients with rare conditions. PATIENTS AND METHODS: This pilot study is a novel example of “patient-initiated research.” After being approached by several members of an international disease-specific support group on a social networking site, we used it to identify patients who had been diagnosed as having at least 1 episode of spontaneous coronary artery dissection and recruited them to participate in a clinical investigation of their condition. Medical records were collected and reviewed, the original diagnosis was independently confirmed by review of imaging studies, and health status (both interval and current) was assessed via specially designed questionnaires and validated assessment tools. RESULTS: Recruitment of all 12 participants was complete within 1 week of institutional review board approval (March 18, 2010). Data collection was completed November 18, 2010. All participants completed the study questionnaires and provided the required medical records and coronary angiograms and ancillary imaging data. CONCLUSION: This study involving patients with spontaneous coronary artery dissection demonstrates the feasibility of and is a successful model for developing a “virtual” multicenter disease registry through disease-specific social media networks to better characterize an uncommon condition. This study is a prime example of patient-initiated research that could be used by other health care professionals and institutions. PMID:21878595

Spontaneous coronary artery dissection: a disease-specific, social networking community-initiated study.

PubMed

Tweet, Marysia S; Gulati, Rajiv; Aase, Lee A; Hayes, Sharonne N

2011-09-01

To develop and assess the feasibility of a novel method for identification, recruitment, and retrospective and prospective evaluation of patients with rare conditions. This pilot study is a novel example of "patient-initiated research." After being approached by several members of an international disease-specific support group on a social networking site, we used it to identify patients who had been diagnosed as having at least 1 episode of spontaneous coronary artery dissection and recruited them to participate in a clinical investigation of their condition. Medical records were collected and reviewed, the original diagnosis was independently confirmed by review of imaging studies, and health status (both interval and current) was assessed via specially designed questionnaires and validated assessment tools. Recruitment of all 12 participants was complete within 1 week of institutional review board approval (March 18, 2010). Data collection was completed November 18, 2010. All participants completed the study questionnaires and provided the required medical records and coronary angiograms and ancillary imaging data. This study involving patients with spontaneous coronary artery dissection demonstrates the feasibility of and is a successful model for developing a "virtual" multicenter disease registry through disease-specific social media networks to better characterize an uncommon condition. This study is a prime example of patient-initiated research that could be used by other health care professionals and institutions.

[The prospects of research on VR rehabilitation engineering].

PubMed

Huang, J; Liu, H; Li, H; Sun, Q; Xu, Y; Ling, D

1999-06-01

In this paper, we present the recent development of Vitual Reality (VR) technology and rehabilitation engineering and discuss the rationality and feasibility of the application of VR to rehabilitation. With VR technology, psychological induction can be better introduced in rehabilitating exercises and patients can be tremendously released from fret during traditional physical training for rehabilitation. The VR is expected to bring about a technological revolution in rehabilitation engineering.

Design of wireless communication system for environmental monitoring

NASA Astrophysics Data System (ADS)

Jiang, Li; Zhang, Xiaoyang; Sun, Zhixiang; Tian, Youcheng; Wang, Juan; Guo, Jianghua

2017-05-01

This paper introduces the basic principle and advantages of GPRS data transmission, and discusses in detail about the hardware structure of the GPRS module, the connection mode and the research process of GPRS application in the device. The feasibility and superiority of GPRS data transmission in wireless water quality monitoring device have been tested and proved, which provides great convenience for water quality monitoring, and has good application prospect.

Auricular acupuncture for sleep disturbance in veterans with post-traumatic stress disorder: a feasibility study.

PubMed

King, Heather C; Spence, Dennis L; Hickey, Anita H; Sargent, Paul; Elesh, Ronald; Connelly, Cynthia D

2015-05-01

The purpose of this study was to examine the feasibility and acceptability of an auricular acupuncture (AA) insomnia regimen among Operation Iraqi Freedom and Operation Enduring Freedom veterans with post-traumatic stress disorder and sleep disturbance. Secondarily, this study examined the effect of an AA insomnia regimen on objective sleep times by wrist actigraphy, subjective sleep times by sleep diary, and sleep quality ratings utilizing the Pittsburg Sleep Quality Index. Veterans (n = 30) were randomized to receive a 3-week AA insomnia regimen. Veterans receiving the AA insomnia regimen reported it as a more acceptable treatment for sleep disturbance than subjects in the control group (AA group median = 5 vs. control group median = 3, p = 0.004). Significant differences between groups were found on the sleep quality and daytime dysfunction components of the Pittsburgh Sleep Quality Index (p = 0.003, p = 0.004). No other significant differences between groups were found for objective and subjective sleep measures. These results suggest that an AA insomnia regimen may improve sleep quality and daytime dysfunction among veterans with post-traumatic stress disorder. Future, large-scale, prospective clinical trials are needed to examine AA effects on sleep. Reprint & Copyright © 2015 Association of Military Surgeons of the U.S.

High-resolution myocardial stress perfusion at 3 T in patients with suspected coronary artery disease.

PubMed

Meyer, Carsten; Strach, Katharina; Thomas, Daniel; Litt, Harold; Nähle, Claas P; Tiemann, Klaus; Schwenger, Ulrich; Schild, Hans H; Sommer, Torsten

2008-02-01

To implement a high-resolution first-pass myocardial perfusion imaging protocol (HRPI) at 3 T, and to evaluate the feasibility, image quality and accuracy of this approach prospectively in patients with suspected CAD. We hypothesized that utilizing the gain in SNR at 3 T to increase spatial resolution would reduce partial volume effects and subendocardial dark rim artifacts in comparison to 1.5 T. HRPI studies were performed on 60 patients using a segmented k-space gradient echo sequence (in plane resolution 1.97 x 1.94 mm(2)). Semiquantitative assessment of dark rim artifacts was performed for the stress studies on a slice-by-slice basis. Qualitative visual analysis was compared to quantitative coronary angiography (QCA) results; hemodynamically significant CAD was defined as stenosis >or=70% at QCA. Dark rim artifacts appeared in 108 of 180 slices (average extent 1.3 +/- 1.2 mm representing 11.8 +/- 10.8% of the transmural myocardial thickness). Sensitivity, specifity, and test accuracy for the detection of significant CAD were 89%,79%, and 85%. HRPI studies at 3 T are feasible in a clinical setting, providing good image quality and high accuracy for detection of significant CAD. The presence of dark rim artifacts does not appear to represent a diagnostic problem when using a HRPI approach.

Forward-viewing endoscopic ultrasound-guided NOTES interventions: A study on peritoneoscopic potential

PubMed Central

Jeong, Seung Uk; Aizan, Hassanuddin; Song, Tae Jun; Seo, Dong Wan; Kim, Su-Hui; Park, Do Hyun; Lee, Sang Soo; Lee, Sung Koo; Kim, Myung-Hwan

2013-01-01

AIM: To evaluate the feasibility of diagnostic and therapeutic transgastric (TG) peritoneoscopic interventions with a forward-viewing endoscopic ultrasound (FV-EUS). METHODS: This prospective endoscopic experimental study used an animal model. Combined TG peritoneoscopic interventions and EUS examination of the intra-abdominal organs were performed using an FV-EUS on 10 animal models (1 porcine and 9 canine). The procedures carried out include EUS evaluation and endoscopic biopsy of intraperitoneal organs, EUS-guided fine needle aspiration (EUS-FNA), EUS-guided radiofrequency ablation (EUS-RFA), and argon plasma coagulation (APC) for hemostatic control. The animals were kept alive for 7 d, and then necropsy was performed to evaluate results and complications. RESULTS: In all 10 animals, TG peritoneoscopy, followed by endoscopic biopsy for the liver, spleen, abdominal wall, and omentum, was performed successfully. APC helped control minor bleeding. Visualization of intra-abdominal solid organs with real-time EUS was accomplished with ease. Intraperitoneal EUS-FNA was successfully performed on the liver, spleen, and kidney. Similarly, a successful outcome was achieved with EUS-RFA of the hepatic parenchyma. No adverse events were recorded during the study. CONCLUSION: Peritoneoscopic natural orifice transluminal endoscopic surgery (NOTES) interventions through FV-EUS were feasible in providing evaluation and performing endoscopic procedures. It promises potential as a platform for future EUS-based NOTES. PMID:24222961

Detection of tuberculosis patterns in digital photographs of chest X-ray images using Deep Learning: feasibility study.

PubMed

Becker, A S; Blüthgen, C; Phi van, V D; Sekaggya-Wiltshire, C; Castelnuovo, B; Kambugu, A; Fehr, J; Frauenfelder, T

2018-03-01

To evaluate the feasibility of Deep Learning-based detection and classification of pathological patterns in a set of digital photographs of chest X-ray (CXR) images of tuberculosis (TB) patients. In this prospective, observational study, patients with previously diagnosed TB were enrolled. Photographs of their CXRs were taken using a consumer-grade digital still camera. The images were stratified by pathological patterns into classes: cavity, consolidation, effusion, interstitial changes, miliary pattern or normal examination. Image analysis was performed with commercially available Deep Learning software in two steps. Pathological areas were first localised; detected areas were then classified. Detection was assessed using receiver operating characteristics (ROC) analysis, and classification using a confusion matrix. The study cohort was 138 patients with human immunodeficiency virus (HIV) and TB co-infection (median age 34 years, IQR 28-40); 54 patients were female. Localisation of pathological areas was excellent (area under the ROC curve 0.82). The software could perfectly distinguish pleural effusions from intraparenchymal changes. The most frequent misclassifications were consolidations as cavitations, and miliary patterns as interstitial patterns (and vice versa). Deep Learning analysis of CXR photographs is a promising tool. Further efforts are needed to build larger, high-quality data sets to achieve better diagnostic performance.

Improving newborn screening for cystic fibrosis using next-generation sequencing technology: a technical feasibility study.

PubMed

Baker, Mei W; Atkins, Anne E; Cordovado, Suzanne K; Hendrix, Miyono; Earley, Marie C; Farrell, Philip M

2016-03-01

Many regions have implemented newborn screening (NBS) for cystic fibrosis (CF) using a limited panel of cystic fibrosis transmembrane regulator (CFTR) mutations after immunoreactive trypsinogen (IRT) analysis. We sought to assess the feasibility of further improving the screening using next-generation sequencing (NGS) technology. An NGS assay was used to detect 162 CFTR mutations/variants characterized by the CFTR2 project. We used 67 dried blood spots (DBSs) containing 48 distinct CFTR mutations to validate the assay. NGS assay was retrospectively performed on 165 CF screen-positive samples with one CFTR mutation. The NGS assay was successfully performed using DNA isolated from DBSs, and it correctly detected all CFTR mutations in the validation. Among 165 screen-positive infants with one CFTR mutation, no additional disease-causing mutation was identified in 151 samples consistent with normal sweat tests. Five infants had a CF-causing mutation that was not included in this panel, and nine with two CF-causing mutations were identified. The NGS assay was 100% concordant with traditional methods. Retrospective analysis results indicate an IRT/NGS screening algorithm would enable high sensitivity, better specificity and positive predictive value (PPV). This study lays the foundation for prospective studies and for introducing NGS in NBS laboratories.

Early prediction of cerebral palsy by computer-based video analysis of general movements: a feasibility study.

PubMed

Adde, Lars; Helbostad, Jorunn L; Jensenius, Alexander R; Taraldsen, Gunnar; Grunewaldt, Kristine H; Støen, Ragnhild

2010-08-01

The aim of this study was to investigate the predictive value of a computer-based video analysis of the development of cerebral palsy (CP) in young infants. A prospective study of general movements used recordings from 30 high-risk infants (13 males, 17 females; mean gestational age 31wks, SD 6wks; range 23-42wks) between 10 and 15 weeks post term when fidgety movements should be present. Recordings were analysed using computer vision software. Movement variables, derived from differences between subsequent video frames, were used for quantitative analyses. CP status was reported at 5 years. Thirteen infants developed CP (eight hemiparetic, four quadriparetic, one dyskinetic; seven ambulatory, three non-ambulatory, and three unknown function), of whom one had fidgety movements. Variability of the centroid of motion had a sensitivity of 85% and a specificity of 71% in identifying CP. By combining this with variables reflecting the amount of motion, specificity increased to 88%. Nine out of 10 children with CP, and for whom information about functional level was available, were correctly predicted with regard to ambulatory and non-ambulatory function. Prediction of CP can be provided by computer-based video analysis in young infants. The method may serve as an objective and feasible tool for early prediction of CP in high-risk infants.

OS7.7 Feasibility and toxicity of concomitant radiochemotherapy with vincristine in adult patients with medulloblastoma - results from the NOA-07 trial

PubMed Central

Seidel, C.; Reimers, C.; Beier, D.; Pietsch, T.; Warmuth-Metz, M.; Bogdahn, U.; Kortmann, R.; Hau, P.

2016-01-01

Abstract Introduction: Medulloblastoma is a tumor of the cerebellum that is rare in adults with an incidence of about 0.6 cases per million per year. In children the introduction of chemotherapy with cisplatin, lomustine and vincristine in combination with craniospinal radiotherapy led to a significant improvement of overall survival. In adults, this regimen was never prospectively investigated in a clinical trial. Methods. The NOA-07 trial is a prospective single arm Phase II study to evaluate toxicity of craniospinal irradiation (1.6 Gy/35.2 Gy, posterior fossa boost 1.8 Gy/55.0 Gy) in combination with vincristine (1.5 mg/m2 weekly, ceiling dose 2.0 mg) followed by adjuvant chemotherapy with a maximum 8 of 6-weekly cycles of cisplatin (70 mg/m2, day 1), lomustine (75 mg/m2, day 1) and vincristine (1.5 g/m2, ceiling dose 2.0 mg, day 1, 8, 15) in adults with medulloblastoma. Here, we report on feasibility and toxicity of the concomitant radiochemotherapy. Results. 30 patients with medulloblastoma were recruited in 15 German centers. Radiotherapy was completed in all patients. Treatment interruptions occurred in 3/30 patients (toxicity related: 2, compliance: 1). Leukopenia was the major toxicity with grade 3 and 4 (CTC Version 3.0) occurring in 11 of 30 patients and 1 of 30 patients, respectively. Grade 3 to 4 thrombocytopenia occurred in 1 patient. Grade 3 to 4 infections occurred in 3 patients. Polyneuropathy due to vincristine was the most prevalent adverse event (Grade 1: 5, Grade 2: 4, Grade 3: 5 of 30 patients). Frequent but less severe toxicities involved sickness, dermatitis and alopecia. Conclusion. Concomitant radiochemotherapy with vincristine was feasible in adults with medulloblastoma. Leukopenia and polyneuropathy are major complications, pointing out that polyneuropathy occurs already early in treatment after application of only 1 to 6 doses in a substantial number of patients. Toxicity of the complete treatment protocol including adjuvant chemotherapy will be analysed and presented elsewhere.

Feasibility of functional neuroimaging to understand adolescent women's sexual decision making.

PubMed

Hensel, Devon J; Hummer, Tom A; Acrurio, Lindsay R; James, Thomas W; Fortenberry, J Dennis

2015-04-01

For young women, new sexual experiences normatively increase after puberty and coincide with extensive changes to brain regions governing self-regulation of risk behavior. These neurodevelopmental changes could leave some young women vulnerable for negative sexual outcomes, including sexually transmitted infection and unintended pregnancy. We evaluated the feasibility of using functional neuroimaging to understand the sexual decision making of adolescent women. Adolescent women (N = 14; 14-15 years) completed enrollment interviews, a neuroimaging task gauging neural activation to appetitive stimuli, and 30 days of prospective diaries following the scan characterizing daily affect and sexual behaviors. Descriptive and inferential statistics assessed the association between imaging and behavioral data. Young women were highly compliant with neuroimaging and diary protocol. Neural activity in a cognitive-affective network, including prefrontal and anterior cingulate regions, was significantly greater during low-risk decisions. Compared with other decisions, high-risk sexual decisions elicited greater activity in the anterior cingulate, and low-risk sexual decision elicited greater activity in regions of the visual cortex. Young women's sexual decision ratings were linked to their sexual history characteristics and daily self-reports of sexual emotions and behaviors. It is feasible to recruit and retain a cohort of female participants to perform a functional magnetic resonance imaging task focused on making decisions about sex, on the basis of varying levels of hypothetical sexual risk, and to complete longitudinal prospective diaries following this task. Preliminary evidence suggests that risk level differentially impacts brain activity related to sexual decision making in these women, which may be related to past and future sexual behaviors. Copyright © 2015 Society for Adolescent Health and Medicine. Published by Elsevier Inc. All rights reserved.

Genomics-Driven Precision Medicine for Advanced Pancreatic Cancer: Early Results from the COMPASS Trial.

PubMed

Aung, Kyaw L; Fischer, Sandra E; Denroche, Robert E; Jang, Gun-Ho; Dodd, Anna; Creighton, Sean; Southwood, Bernadette; Liang, Sheng-Ben; Chadwick, Dianne; Zhang, Amy; O'Kane, Grainne M; Albaba, Hamzeh; Moura, Shari; Grant, Robert C; Miller, Jessica K; Mbabaali, Faridah; Pasternack, Danielle; Lungu, Ilinca M; Bartlett, John M S; Ghai, Sangeet; Lemire, Mathieu; Holter, Spring; Connor, Ashton A; Moffitt, Richard A; Yeh, Jen Jen; Timms, Lee; Krzyzanowski, Paul M; Dhani, Neesha; Hedley, David; Notta, Faiyaz; Wilson, Julie M; Moore, Malcolm J; Gallinger, Steven; Knox, Jennifer J

2018-03-15

Purpose: To perform real-time whole genome sequencing (WGS) and RNA sequencing (RNASeq) of advanced pancreatic ductal adenocarcinoma (PDAC) to identify predictive mutational and transcriptional features for better treatment selection. Experimental Design: Patients with advanced PDAC were prospectively recruited prior to first-line combination chemotherapy. Fresh tumor tissue was acquired by image-guided percutaneous core biopsy for WGS and RNASeq. Laser capture microdissection was performed for all cases. Primary endpoint was feasibility to report WGS results prior to first disease assessment CT scan at 8 weeks. The main secondary endpoint was discovery of patient subsets with predictive mutational and transcriptional signatures. Results: Sixty-three patients underwent a tumor biopsy between December 2015 and June 2017. WGS and RNASeq were successful in 62 (98%) and 60 (95%), respectively. Genomic results were reported at a median of 35 days (range, 19-52 days) from biopsy, meeting the primary feasibility endpoint. Objective responses to first-line chemotherapy were significantly better in patients with the classical PDAC RNA subtype compared with those with the basal-like subtype ( P = 0.004). The best progression-free survival was observed in those with classical subtype treated with m-FOLFIRINOX. GATA6 expression in tumor measured by RNA in situ hybridization was found to be a robust surrogate biomarker for differentiating classical and basal-like PDAC subtypes. Potentially actionable genetic alterations were found in 30% of patients. Conclusions: Prospective genomic profiling of advanced PDAC is feasible, and our early data indicate that chemotherapy response differs among patients with different genomic/transcriptomic subtypes. Clin Cancer Res; 24(6); 1344-54. ©2017 AACR . ©2017 American Association for Cancer Research.

After Contact - Then What?

NASA Astrophysics Data System (ADS)

Harrison, Albert A.

Few topics ignite the imagination as do the prospects of encountering extraterrestrial life - and what this may mean for individuals, societies, and cultures. Until recently speculation fell largely within the realms of philosophy, science fiction, and UFO studies. By 1960, however, the theoretical feasibility of interstellar transmissions coupled with Frank Drake's initial empirical search, Project Ozma, established a need to put such speculation on a firmer footing. Drake's work had gained the attention of Donald Norman, a psychologist who was developing a report on the peaceful uses of outer space for the US Congress. Whereas most of this report dealt with topics such as communications satellites, remote sensing, and human space exploration, portions dwelled on the possible implications of the discovery.

Prospects of In-Situ α-Al2O3 as an Inoculant in Aluminum: A Feasibility Study

NASA Astrophysics Data System (ADS)

Sreekumar, V. M.; Hari Babu, N.; Eskin, D. G.

2017-09-01

In-situ α-Al2O3 was successfully synthesized and dispersed in Al alloy using B2O3 and ultrasonication-aided liquid mixing technique. Microstructure analysis identified α-Al2O3 as the most common phase in the composite master alloy, whereas AlB12 was frequently observed and AlB2 was rarely found in the alloy. Grain refinement analysis of selected Al alloys registered a transition of columnar to equiaxial grains of α-Al with the inoculation of the master alloy and ultrasonication treatment. Similarly, an improvement in the mechanical properties of A357 alloy was observed with the combination of inoculation and ultrasonication treatment.

Electronic Adherence Monitoring in a High-Utilizing Pediatric Asthma Cohort: A Feasibility Study

PubMed Central

Chang, Joyce; Wynter, Sheri-Ann; Fowler, Jessica C; Long, Jin; Bryant-Stephens, Tyra C

2016-01-01

Background Inner-city, minority children with asthma have the highest rates of morbidity and death from asthma and the lowest rates of asthma controller medication adherence. Some recent electronic medication monitoring interventions demonstrated dramatic improvements in adherence in lower-risk populations. The feasibility and acceptability of such an intervention in the highest-risk children with asthma has not been studied. Objective Our objective was to assess the feasibility and acceptability of a community health worker-delivered electronic adherence monitoring intervention among the highest utilizers of acute asthma care in an inner-city practice. Methods This was a prospective cohort pilot study targeting children with the highest frequency of asthma-related emergency department and hospital care within a local managed care Medicaid plan. The 3-month intervention included motivational interviewing, electronic monitoring of controller and rescue inhaler use, and outreach by a community health worker for predefined medication alerts. We measured acceptability by using a modified technology acceptability model and changes in asthma control using the Asthma Control Test (ACT). Given prominent feasibility issues, we describe qualitative patterns of medication use at baseline only. Results We enrolled 14 non-Hispanic black children with a median age of 3.5 years. Participants averaged 7.8 emergency or hospital visits in the year preceding enrollment. We observed three distinct patterns of baseline controller use: 4 patients demonstrated sustained use, 5 patients had periodic use, and 5 patients lapsed within 2 weeks. All participants initiated use of the electronic devices; however, no modem signal was transmitted for 5 or the 14 participants after a mean of 45 days. Of the 9 (64% of total) caregivers who completed the final study visit, all viewed the electronic monitoring device favorably and would recommend it to friends, and 5 (56%) believed that the device helped to improve asthma control. ACT scores improved by a mean of 2.7 points (P=.05) over the 3-month intervention. Conclusions High-utilizer, minority families who completed a community health worker-delivered electronic adherence intervention found it generally acceptable. Prominent feasibility concerns, however, such as recruitment, data transmission failure, and lost devices, should be carefully considered when designing interventions in this setting. PMID:27335355

An optimal ultrasonographic diagnostic test for early gout: A prospective controlled study

PubMed Central

Petraitis, Mykolas; Apanaviciene, Indre; Virviciute, Dalia; Baranauskaite, Asta

2017-01-01

Objective To identify the optimal sites for classification of early gout by ultrasonography. Methods Sixty patients with monosodium urate crystal-proven gout (25 with early gout [≤2-year symptom duration], 35 with late gout [>2-year symptom duration], and 36 normouricemic healthy controls) from one centre were prospectively evaluated. Standardized blinded ultrasound examination of 36 joints and the triceps and patellar tendons was performed to identify tophi and the double contour (DC) sign. Results Ultrasonographic sensitivity was lower in early than late gout. Binary logistic regression analysis showed that two ultrasonographic signs (tophi in the first metatarsophalangeal joint [odds ratio, 16.46] and the DC sign in the ankle [odds ratio, 25.18]) significantly contributed to the final model for early gout diagnosis (sensitivity and specificity of 84% and 81%, respectively). The inter-reader reliability kappa value for the DC sign and tophi was 0.712. Conclusions Four-joint investigation (both first metatarsophalangeal joints for tophi and both ankles for the DC sign) is feasible and reliable and could be proposed as a screening test for early ultrasonographic gout classification in daily practice. PMID:28617199

An optimal ultrasonographic diagnostic test for early gout: A prospective controlled study.

PubMed

Norkuviene, Eleonora; Petraitis, Mykolas; Apanaviciene, Indre; Virviciute, Dalia; Baranauskaite, Asta

2017-08-01

Objective To identify the optimal sites for classification of early gout by ultrasonography. Methods Sixty patients with monosodium urate crystal-proven gout (25 with early gout [≤2-year symptom duration], 35 with late gout [>2-year symptom duration], and 36 normouricemic healthy controls) from one centre were prospectively evaluated. Standardized blinded ultrasound examination of 36 joints and the triceps and patellar tendons was performed to identify tophi and the double contour (DC) sign. Results Ultrasonographic sensitivity was lower in early than late gout. Binary logistic regression analysis showed that two ultrasonographic signs (tophi in the first metatarsophalangeal joint [odds ratio, 16.46] and the DC sign in the ankle [odds ratio, 25.18]) significantly contributed to the final model for early gout diagnosis (sensitivity and specificity of 84% and 81%, respectively). The inter-reader reliability kappa value for the DC sign and tophi was 0.712. Conclusions Four-joint investigation (both first metatarsophalangeal joints for tophi and both ankles for the DC sign) is feasible and reliable and could be proposed as a screening test for early ultrasonographic gout classification in daily practice.

Ultra-bright GeV photon source via controlled electromagnetic cascades in laser-dipole waves

NASA Astrophysics Data System (ADS)

Gonoskov, Arkady; Bashinov, Alexey; Efimenko, Evgeny; Muraviev, Alexander; Kim, Arkady; Ilderton, Anton; Bastrakov, Sergey; Meyerov, Iosif; Marklund, Mattias; Sergeev, Alexander

2017-10-01

The prospect of achieving conditions for triggering strong-field QED phenomena at upcoming large-scale laser facilities raises a number of intriguing questions. What kind of new effects and interaction regimes can be accessed by basic QED phenomena? What are the minimal (optimal) requirements to trigger these effects and enter these regimes? How can we, from this, gain new fundamental knowledge or create important applications? The talk will concern the prospects of producing high fluxes of GeV photons by triggering a special type of self-sustaining cascade in the field of several colliding laser pulses that form a dipole wave. Apart from reaching the highest field strength for a given total power of laser pulses, the dipole wave enables anomalous radiative trapping that favors pair production and high-energy photon generation. An extensive theoretical analysis and 3D QED-PIC simulations indicate that the concept is feasible at upcoming large-scale laser facilities of 10 PW level and can provide an extraordinary intense source of GeV photons for novel experimental studies in nuclear and quark-nuclear physics.

Transparent magnesium aluminate spinel: a prospective biomaterial for esthetic orthodontic brackets.

PubMed

Krishnan, Manu; Tiwari, Brijesh; Seema, Saraswathy; Kalra, Namitha; Biswas, Papiya; Rajeswari, Kotikalapudi; Suresh, Madireddy Buchi; Johnson, Roy; Gokhale, Nitin M; Iyer, Satish R; Londhe, Sanjay; Arora, Vimal; Tripathi, Rajendra P

2014-11-01

Adult orthodontics is recently gaining popularity due to its importance in esthetics, oral and general health. However, none of the currently available alumina or zirconia based ceramic orthodontic brackets meet the esthetic demands of adult patients. Inherent hexagonal lattice structure and associated birefringence limits the visible light transmission in polycrystalline alumina and make them appear white and non transparent. Hence focus of the present study was to assess the feasibility of using magnesium aluminate (MgAl2O4) spinel; a member of the transparent ceramic family for esthetic orthodontic brackets. Transparent spinel specimens were developed from commercially available white spinel powder through colloidal shaping followed by pressureless sintering and hot isostatic pressing at optimum conditions of temperature and pressure. Samples were characterized for chemical composition, phases, density, hardness, flexural strength, fracture toughness and optical transmission. Biocompatibility was evaluated with in-vitro cell line experiments for cytotoxicity, apoptosis and genotoxicity. Results showed that transparent spinel samples had requisite physico-chemical, mechanical, optical and excellent biocompatibility for fabricating orthodontic brackets. Transparent spinel developed through this method demonstrated its possibility as a prospective biomaterial for developing esthetic orthodontic brackets.

Validation of the Penn Acoustic Neuroma Quality-of-Life Scale (PANQOL) for Spanish-Speaking Patients.

PubMed

Medina, Maria Del Mar; Carrillo, Alvaro; Polo, Ruben; Fernandez, Borja; Alonso, Daniel; Vaca, Miguel; Cordero, Adela; Perez, Cecilia; Muriel, Alfonso; Cobeta, Ignacio

2017-04-01

Objective To perform translation, cross-cultural adaptation, and validation of the Penn Acoustic Neuroma Quality-of-Life Scale (PANQOL) to the Spanish language. Study Design Prospective study. Setting Tertiary neurotologic referral center. Subjects and Methods PANQOL was translated and translated back, and a pretest trial was performed. The study included 27 individuals diagnosed with vestibular schwannoma. Inclusion criteria were adults with untreated vestibular schwannoma, diagnosed in the past 12 months. Feasibility, internal consistency, test-retest reliability, construct validity, and ceiling and floor effects were assessed for the present study. Results The mean overall score of the PANQOL was 69.21 (0-100 scale, lowest to highest quality of life). Cronbach's α was 0.87. Intraclass correlation coefficient was performed for each item, with an overall score of 0.92. The κ coefficient scores were between moderate and almost perfect in more than 92% of patients. Anxiety and energy domains of the PANQOL were correlated with both physical and mental components of the SF-12. Hearing, balance, and pain domains were correlated with the SF-12 physical component. Facial and general domains were not significantly correlated with any component of the SF-12. Furthermore, the overall score of the PANQOL was correlated with the physical component of the SF-12. Conclusion Feasibility, internal consistency, reliability, and construct validity outcomes in the current study support the validity of the Spanish version of the PANQOL.

The Asthma Mobile Health Study, a large-scale clinical observational study using ResearchKit.

PubMed

Chan, Yu-Feng Yvonne; Wang, Pei; Rogers, Linda; Tignor, Nicole; Zweig, Micol; Hershman, Steven G; Genes, Nicholas; Scott, Erick R; Krock, Eric; Badgeley, Marcus; Edgar, Ron; Violante, Samantha; Wright, Rosalind; Powell, Charles A; Dudley, Joel T; Schadt, Eric E

2017-04-01

The feasibility of using mobile health applications to conduct observational clinical studies requires rigorous validation. Here, we report initial findings from the Asthma Mobile Health Study, a research study, including recruitment, consent, and enrollment, conducted entirely remotely by smartphone. We achieved secure bidirectional data flow between investigators and 7,593 participants from across the United States, including many with severe asthma. Our platform enabled prospective collection of longitudinal, multidimensional data (e.g., surveys, devices, geolocation, and air quality) in a subset of users over the 6-month study period. Consistent trending and correlation of interrelated variables support the quality of data obtained via this method. We detected increased reporting of asthma symptoms in regions affected by heat, pollen, and wildfires. Potential challenges with this technology include selection bias, low retention rates, reporting bias, and data security. These issues require attention to realize the full potential of mobile platforms in research and patient care.

Quantitative diagnostic method for biceps long head tendinitis by using ultrasound.

PubMed

Huang, Shih-Wei; Wang, Wei-Te

2013-01-01

To investigate the feasibility of grayscale quantitative diagnostic method for biceps tendinitis and determine the cut-off points of a quantitative biceps ultrasound (US) method to diagnose biceps tendinitis. Design. Prospective cross-sectional case controlled study. Outpatient rehabilitation service. A total of 336 shoulder pain patients with suspected biceps tendinitis were recruited in this prospective observational study. The grayscale pixel data of the range of interest (ROI) were obtained for both the transverse and longitudinal views of the biceps US. A total of 136 patients were classified with biceps tendinitis, and 200 patients were classified as not having biceps tendinitis based on the diagnostic criteria. Based on the Youden index, the cut-off points were determined as 26.85 for the transverse view and 21.25 for the longitudinal view of the standard deviation (StdDev) of the ROI values, respectively. When the ROI evaluation of the US surpassed the cut-off point, the sensitivity was 68% and the specificity was 90% in the StdDev of the transverse view, and the sensitivity was 81% and the specificity was 73% in the StdDev of the longitudinal view to diagnose biceps tendinitis. For equivocal cases or inexperienced sonographers, our study provides a more objective method for diagnosing biceps tendinitis in shoulder pain patients.

Nosocomial pneumonia in the ICU: a prospective cohort study.

PubMed

Hyllienmark, Petra; Gårdlund, Bengt; Persson, Jan-Olov; Ekdahl, Karl

2007-01-01

Ventilator-associated pneumonia (VAP) is the most common intensive care unit (ICU)-acquired infection among patients requiring mechanical ventilation. A prospective surveillance programme of all patients has been implemented at the ICU, Karolinska University Hospital, Sweden since 2001. Within this programme, incidence and risk factors for ICU-acquired pneumonia and associated death over a 2-y period have been studied. Of 329 patients enrolled in the study, 221 required mechanical ventilation. 33 of 221 patients (15%) developed VAP, corresponding to a rate of 29 VAP/1000 ventilator d. Risk factors for VAP were aspiration (hazard ratio 3.79; 95% CI 1.48-9.68), recent surgery (HR 3.58; 95% CI 1.15-11.10) and trauma (HR 3.00; 95% CI 1.03-8.71). 11 patients of 33 (33%) with VAP died within 28 d compared to 46 of 288 (16%) without ICU-acquired pneumonia (odds ratio 2.73; 95% CI 0.97-7.63). We conclude that: 1) incidence of VAP was 15% and the most important risk factor was aspiration; 2) APACHE II score > or = 20 is a stronger predictor for poor outcome than VAP; 3) a minority of patients with APACHE II score > or = 20 develop VAP; and 4) continuous surveillance programmes are feasible and provide valuable data for improvement of quality of care.

Feasibility of real-time location systems in monitoring recovery after major abdominal surgery.

PubMed

Dorrell, Robert D; Vermillion, Sarah A; Clark, Clancy J

2017-12-01

Early mobilization after major abdominal surgery decreases postoperative complications and length of stay, and has become a key component of enhanced recovery pathways. However, objective measures of patient movement after surgery are limited. Real-time location systems (RTLS), typically used for asset tracking, provide a novel approach to monitoring in-hospital patient activity. The current study investigates the feasibility of using RTLS to objectively track postoperative patient mobilization. The real-time location system employs a meshed network of infrared and RFID sensors and detectors that sample device locations every 3 s resulting in over 1 million data points per day. RTLS tracking was evaluated systematically in three phases: (1) sensitivity and specificity of the tracking device using simulated patient scenarios, (2) retrospective passive movement analysis of patient-linked equipment, and (3) prospective observational analysis of a patient-attached tracking device. RTLS tracking detected a simulated movement out of a room with sensitivity of 91% and specificity 100%. Specificity decreased to 75% if time out of room was less than 3 min. All RTLS-tagged patient-linked equipment was identified for 18 patients, but measurable patient movement associated with equipment was detected for only 2 patients (11%) with 1-8 out-of-room walks per day. Ten patients were prospectively monitored using RTLS badges following major abdominal surgery. Patient movement was recorded using patient diaries, direct observation, and an accelerometer. Sensitivity and specificity of RTLS patient tracking were both 100% in detecting out-of-room ambulation and correlated well with direct observation and patient-reported ambulation. Real-time location systems are a novel technology capable of objectively and accurately monitoring patient movement and provide an innovative approach to promoting early mobilization after surgery.

An assessment of the feasibility and effectiveness of an e-learning module in delivering a curriculum in radiation protection to undergraduate medical students.

PubMed

Leong, Sum; Mc Laughlin, Patrick; O'Connor, Owen J; O'Flynn, Siun; Maher, Michael M

2012-03-01

Integrating radiation protection (RP) education in the undergraduate medical curriculum is gaining importance and is mandatory in certain jurisdictions. An e-learning module for RP was developed at the authors' medical school and was integrated into year 4 of the 5-year undergraduate medical program. The aim of this study was to investigate its impact on RP knowledge, student preferences for various teaching methods, self-assessment of RP knowledge, and perceptions of career prospects in radiology. Likert-type 5-point scale evaluations and general comments about the RP module and various methods of teaching were also obtained. An e-learning module in RP was designed and presented to year 4 medical undergraduates. All students were required to complete premodule and postmodule questionnaires. Eighty-nine percent (n = 113) and 99% (n = 126) of the 127 medical students successfully completed and returned the premodule and postmodule questionnaires, respectively. After the e-learning module, students' postmodule RP knowledge had improved significantly. Analysis of postmodule RP knowledge suggested that a favorable self-assessment of knowledge of RP, perception of career prospects in radiology, and completion of the e-learning module with an increased number of sessions were factors predictive of improved RP knowledge. Students expressed a preference for didactic lectures and clinical attachment for instruction in RP over e-learning. The development of an e-learning module in RP is feasible and results in improved knowledge of RP among medical undergraduates. Combining e-learning and more traditional educational programs such as a clinical radiology rotation is likely to improve student experience. Copyright © 2012 American College of Radiology. Published by Elsevier Inc. All rights reserved.

Development of the teaching simulator based on animated film to strengthening pedagogical competencies of prospective teachers

NASA Astrophysics Data System (ADS)

Fatimah, Siti; Setiawan, Wawan; Kusnendar, Jajang; Rasim, Junaeti, Enjun; Anggraeni, Ria

2017-05-01

Debriefing of pedagogical competence through both theory and practice which became a requirement for prospective teachers were through micro teaching and teaching practice program. But, some reports from the partner schools stated that the participants of teaching practice program have not well prepared on implementing the learning in the classroom because of lacking the debriefing. In line with the development of information technology, it is very possible to develop a media briefing of pedagogical competencies for prospective teachers through an application so that they can use it anytime and anywhere. This study was one answer to the problem of unpreparedness participants of the teaching practice program. This study developed a teaching simulator, which was an application for learning simulation with the animated film to enhance the professional pedagogical competence prospective teachers. By the application of this teaching simulator, students as prospective teacher could test their own pedagogic competence through learning models with different varied characteristics of students. Teaching Simulator has been equipped with features that allow users to be able to explore the quality of teaching techniques that they employ for the teaching and learning activities in the classroom. These features included the election approaches, the student's character, learning materials, questioning techniques, discussion, and evaluation. Teaching simulator application provided the ease of prospective teachers or teachers in implementing the development of lessons for practice in the classroom. Applications that have been developed to apply simulation models allow users to freely manage a lesson. Development of teaching simulator application was passed through the stages which include needs assessment, design, coding, testing, revision, improvement, grading, and packaging. The application of teaching simulator was also enriched with some real instructional video as a comparison for the user. Based on the two experts, the media expert and education expert, stated that the application of teaching simulator is feasible to be used as an instrument for the debriefing of students as potential participants of the teaching practice program. The results of the use of the application to the students as potential participants of teaching practice program, showed significant increases in the pedagogic competence. This study was presented at an international seminar and in the process of publishing in international reputated journals. Applications teaching simulator was in the process of registration to obtain the copyright of the Ministry of Justice and Human Rights. Debriefing for prospective teachers to use teaching simulator application could improve the mastery of pedagogy, give clear feedback, and perform repetitions at anytime.

Feasibility and safety of placement of a newly designed, fully covered self-expandable metal stent for refractory benign pancreatic ductal strictures: a pilot study (with video).

PubMed

Park, Do Hyun; Kim, Myung-Hwan; Moon, Sung-Hoon; Lee, Sang Soo; Seo, Dong-Wan; Lee, Sung-Koo

2008-12-01

Painful chronic pancreatitis with main pancreatic ductal strictures is usually managed with endotherapy with a plastic stent. To date, the role of placement of metallic stents, especially uncovered ones in benign pancreatic ductal stricture, has been unsatisfactory as a result of stent dysfunction related to mucosal hyperplasia. We explored the feasibility and safety of temporary placement of a newly designed, fully covered self-expandable metal stent (FCSEMS) in painful chronic pancreatitis and refractory benign pancreatic ductal strictures. A prospective pilot and feasibility study. A tertiary academic center. Thirteen patients with chronic painful pancreatitis of alcoholic (8) or idiopathic (5) etiology. ERCP with temporary FCSEMS placement (2 months). Endoscopic removal of FCSEMSs was performed with a snare or rat-tooth forceps. End points were feasibility, safety, and morbidity. Successful FCSEMS placement was performed in all enrolled patients. After immediate placement of FCSEMS, 2 patients had mild acute pancreatitis related mainly to the stricture dilation procedure (Soehendra stent retriever or balloon dilation). Complications associated with stent placement included 5 migrations (39%, 1 proximal and 4 distal) and 2 incidents of cholestatic liver dysfunction associated with the compression of the bile duct orifice by expansion of FCSEMSs. In 1 patient with proximal migration, the stent was repositioned by an inflated retrieval balloon. Additional endoscopic biliary sphincterotomy with or without biliary stenting was performed in 2 patients with cholestatic liver dysfunction. There was no occurrence of pancreatic sepsis among any patients. FCSEMSs were removed from 9 of 9 patients without stent migration (100% [9/9] as per protocol, and 69% [9/13] as intention to treat, respectively). Improvement or resolution of the pancreatic ductal strictures was confirmed in all 13 patients on follow-up ERCP (2 months after stent placement), regardless of stent migration. Small patient populations without long-term follow-up. Two-month placement of FCSEMSs in patients with refractory benign pancreatic ductal strictures may be feasible and relatively safe. However, stent migration was not uncommon. A further investigation with ideal stent design may therefore be needed before recommending FCSEMSs as a therapeutic option for refractory benign pancreatic ductal strictures.

Individualized Molecular Analyses Guide Efforts (IMAGE): A Prospective Study of Molecular Profiling of Tissue and Blood in Metastatic Triple-Negative Breast Cancer.

PubMed

Parsons, Heather A; Beaver, Julia A; Cimino-Mathews, Ashley; Ali, Siraj M; Axilbund, Jennifer; Chu, David; Connolly, Roisin M; Cochran, Rory L; Croessmann, Sarah; Clark, Travis A; Gocke, Christopher D; Jeter, Stacie C; Kennedy, Mark R; Lauring, Josh; Lee, Justin; Lipson, Doron; Miller, Vincent A; Otto, Geoff A; Rosner, Gary L; Ross, Jeffrey S; Slater, Shannon; Stephens, Philip J; VanDenBerg, Dustin A; Wolff, Antonio C; Young, Lauren E; Zabransky, Daniel J; Zhang, Zhe; Zorzi, Jane; Stearns, Vered; Park, Ben H

2017-01-15

The clinical utility of next-generation sequencing (NGS) in breast cancer has not been demonstrated. We hypothesized that we could perform NGS of a new biopsy from patients with metastatic triple-negative breast cancer (TNBC) in a clinically actionable timeframe. We planned to enroll 40 patients onto a prospective study, Individualized Molecular Analyses Guide Efforts (IMAGE), to evaluate the feasibility of obtaining a new biopsy of a metastatic site, perform NGS (FoundationOne), and convene a molecular tumor board to formulate treatment recommendations within 28 days. We collected blood at baseline and at time of restaging to assess cell-free circulating plasma tumor DNA (ptDNA). We enrolled 26 women with metastatic TNBC who had received ≥1 line of prior chemotherapy, and 20 (77%) underwent NGS of a metastatic site biopsy. Twelve (60%) evaluable patients received treatment recommendations within 28 days of consent. The study closed after 20 patients underwent NGS, based on protocol-specified interim futility analysis. Three patients went on to receive genomically directed therapies. Twenty-four of 26 patients had genetic alterations successfully detected in ptDNA. Among 5 patients, 4 mutations found in tumor tissues were not identified in blood, and 4 mutations found in blood were not found in corresponding tumors. In 9 patients, NGS of follow-up blood samples showed 100% concordance with baseline blood samples. This study demonstrates challenges of performing NGS on prospective tissue biopsies in patients with metastatic TNBC within 28 days, while also highlighting the potential use of blood as a more time-efficient and less invasive method of mutational assessment. Clin Cancer Res; 23(2); 379-86. ©2016 AACR. ©2016 American Association for Cancer Research.

Orthopedic Surgery and Post-Operative Cognitive Decline in Idiopathic Parkinson’s Disease: Considerations from a Pilot Study

PubMed Central

Price, Catherine C.; Levy, Shellie-Anne; Tanner, Jared; Garvan, Cyndi; Ward, Jade; Akbar, Farheen; Bowers, Dawn; Rice, Mark; Okun, Michael

2016-01-01

BACKGROUND Post-operative cognitive dysfunction (POCD) demarks cognitive decline after major surgery but has been studied to date in “healthy” adults. Although individuals with neurodegenerative disorders such as Parkinson’s disease (PD) commonly undergo elective surgery, these individuals have yet to be prospectively followed despite hypotheses of increased POCD risk. OBJECTIVE To conduct a pilot study examining cognitive change pre-post elective orthopedic surgery for PD relative to surgery and non-surgery peers. METHODS A prospective one-year longitudinal design. No-dementia idiopathic PD individuals were actively recruited along with non-PD “healthy” controls (HC) undergoing knee replacement surgery. Non-surgical PD and HC controls were also recruited. Attention/processing speed, inhibitory function, memory recall, animal (semantic) fluency, and motor speed were assessed at baseline (pre-surgery), three-weeks, three-months, and one-year post- orthopedic surgery. Reliable change methods examined individual changes for PD individuals relative to control surgery and control non-surgery peers. RESULTS Over two years we screened 152 older adult surgery or non-surgery candidates with 19 of these individuals having a diagnosis of PD. Final participants included 8 PD (5 surgery, 3 non-surgery), 47 Control Surgery, and 21 Control Non-Surgery. Eighty percent (4 of the 5) PD surgery declined greater than 1.645 standard deviations from their baseline performance on measures assessing processing speed and inhibitory function. This was not observed for the non-surgery PD individuals. CONCLUSION This prospective pilot study demonstrated rationale and feasibility for examining cognitive decline in at-risk neurodegenerative populations. We discuss recruitment and design challenges for examining post-operative cognitive decline in neurodegenerative samples. PMID:26683785

Assessment of Fine Needle Aspiration Feasibility and Specimen Adequacy for Molecular Diagnostics of Benign Vocal Fold Lesions

PubMed Central

Li, Nicole Y. K.; Dailey, Seth; Thibeault, Susan L.

2014-01-01

Objectives/Hypothesis The use of molecular testing is becoming more significant for the diagnosis and classification of disease. The application of fine-needle aspiration (FNA) biopsy as the means of sampling lesions in union with molecular testing could be a powerful combination in laryngology. The objectives of this study were to investigate 1) if FNA was feasible to sample benign vocal fold lesions; 2) if FNA samples provided sufficient RNA quality for molecular analysis; and 3) if gene expression of FNA samples matched paired surgical excised specimens. Study Design Prospective cross-sectional. Methods Fifteen vocal fold specimens were obtained from adult patients undergoing routine surgical removal for benign vocal fold lesions using FNA and surgical excision. Comparisons were made between FNA and excision biopsies for RNA quality. Correlative analysis was completed for RNA expression of nine genes, including decorin (DCN), connective tissue growth factor (CTGF), vascular endothelial growth factor (VEGF), collagen type VI alpha 3 (COL6A3), superoxide dismutase 1 (SOD1), glutathione S-transferase (GST2), collagen type I alpha 2 (COL1A2), ATP binding cassette (ABC), and procollagen I alpha 1 (COL1A1). Results FNA and excision samples demonstrated similar RNA quality (P > 0.05). Per gene expression, four out of nine genes were moderately correlated between the paired samples (P < 0.05). Conclusions FNA of the vocal fold lamina propria is technically feasible to perform. Further improvement in the FNA technology is desirable to optimize RNA quality for reliable gene expression analysis. PMID:23404571

Feasibility and efficacy of sepsis management guidelines in a pediatric intensive care unit in Saudi Arabia: a quality improvement initiative.

PubMed

Hasan, Gamal M; Al-Eyadhy, Ayman A; Temsah, Mohamed-Hani A; Al-Haboob, Ali A; Alkhateeb, Mohammad A; Al-Sohime, Fahad

2018-04-25

Evaluation of feasibility and effectiveness of Surviving Sepsis Campaign (SSC) Guidelines implementation at a Pediatric Intensive Care Unit (PICU) in Saudi Arabia to reduce severe sepsis associated mortality. Retrospective data analysis for a prospective quality improvement (QI) initiative. PICU at King Saud University Medical City, Saudi Arabia. Children ≤14 years of age admitted to the PICU from July 2010 to March 2011 with suspected or proven sepsis. Comparisons were made to a previously admitted group of patients with sepsis from October 2009 to June 2010. Adaptation and implementation of the Surviving Sepsis Campaign-Clinical Practice Guidelines (SSC-CPGs) through AGREE instrument and ADAPTE process. We reported pre- and post-implementation outcome of interest for this QI initiative, annual sepsis-related mortality rate. Furthermore, we reported follow-up of annual mortality rate until December 2016. Sixty-five patients was included in the study (42 in post-guidelines implementation group and 23 in pre-guidelines implementation group). Mortality was insignificantly lower in the post-implementation group (26.2% vs. 47.8%; P = 0.079). However, when adjusted for severity, identified by number of failing organs in the multivariate regression analysis, the mortality difference was favorable for the post-implementation group (P = 0.006). The lower sepsis-related mortality rate was also sustained, with an average mortality rate of 15.11% for the subsequent years (2012-16). Adaptation and implementation of SSC Guidelines in our setting support its feasibility and potential benefits. However, a larger study is recommended to explore detailed compliance rates.

Sentinel lymph node biopsy in endometrial cancer-Feasibility, safety and lymphatic complications.

PubMed

Geppert, Barbara; Lönnerfors, Céline; Bollino, Michele; Persson, Jan

2018-03-01

To compare the rate of lymphatic complications in women with endometrial cancer undergoing sentinel lymph node biopsy versus a full pelvic and infrarenal paraaortic lymphadenectomy, and to examine the overall feasibility and safety of the former. A prospective study of 188 patients with endometrial cancer planned for robotic surgery. Indocyanine green was used to identify the sentinel lymph nodes. In low-risk patients the lymphadenectomy was restricted to removal of sentinel lymph nodes whereas in high-risk patients also a full lymphadenectomy was performed. The impact of the extent of the lymphadenectomy on the rate of complications was evaluated. The bilateral detection rate of sentinel lymph nodes was 96% after cervical tracer injection. No intraoperative complication was associated with the sentinel lymph node biopsy per se. Compared with hysterectomy alone, the additional average operative time for removal of sentinel lymph nodes was 33min whereas 91min were saved compared with a full pelvic and paraaortic lymphadenectomy. Sentinel lymph node biopsy alone resulted in a lower incidence of leg lymphedema than infrarenal paraaortic and pelvic lymphadenectomy (1.3% vs 18.1%, p=0.0003). The high feasibility, the absence of intraoperative complications and the low risk of lymphatic complications supports implementing detection of sentinel lymph nodes in low-risk endometrial cancer patients. Given that available preliminary data on sensitivity and false negative rates in high-risk patients are confirmed in further studies, we also believe that the reduction in lymphatic complications and operative time strongly motivates the sentinel lymph node concept in high-risk endometrial cancer. Copyright © 2017. Published by Elsevier Inc.

Incorporating cardiopulmonary resuscitation training into a cardiac rehabilitation programme: A feasibility study.

PubMed

Cartledge, Susie; Finn, Judith; Bray, Janet E; Case, Rosalind; Barker, Lauren; Missen, Diane; Shaw, James; Stub, Dion

2018-02-01

Patients with a cardiac history are at future risk of cardiac events, including out-of-hospital cardiac arrest. Targeting cardiopulmonary resuscitation (CPR) training to family members of cardiac patients has long been advocated, but is an area in need of contemporary research evidence. An environment yet to be investigated for targeted training is cardiac rehabilitation. To evaluate the feasibility of providing CPR training in a cardiac rehabilitation programme among patients, their family members and staff. A prospective before and after study design was used. CPR training was delivered using video self-instruction CPR training kits, facilitated by a cardiac nurse. Data was collected pre-training, post-training and at one month. Cardiac patient participation rates in CPR classes were high ( n = 56, 72.7% of eligible patients) with a further 27 family members attending training. Patients were predominantly male (60.2%), family members were predominantly female (81.5%), both with a mean age of 65 years. Confidence to perform CPR and willingness to use skills significantly increased post-training (both p<0.001). Post training participants demonstrated a mean compression rate of 112 beats/min and a mean depth of 48 mm. Training reach was doubled as participants shared the video self-instruction kit with a further 87 people. Patients, family members and cardiac rehabilitation staff had positive feedback about the training. We demonstrated that cardiac rehabilitation is an effective and feasible environment to provide CPR training. Using video self-instruction CPR training kits enabled further training reach to the target population.

Feasibility of Real-Time Near-Infrared Fluorescence Tracer Imaging in Sentinel Node Biopsy for Oral Cavity Cancer Patients.

PubMed

Christensen, Anders; Juhl, Karina; Charabi, Birgitte; Mortensen, Jann; Kiss, Katalin; Kjær, Andreas; von Buchwald, Christian

2016-02-01

Sentinel node biopsy (SNB) is an established method in oral squamous cell carcinoma (OSCC) for staging the cN0 neck and to select patients who will benefit from a neck dissection. Near-infrared fluorescence (NIRF) imaging has the potential to improve the SNB procedure by facilitating intraoperative visual identification of the sentinel lymph node (SN). The purpose of this study was to evaluate the feasibility of fluorescence tracer imaging for SN detection in conjunction with conventional radio-guided technique. Prospective study of patients with primary OSCC planned for tumor resection and SNB. Thirty patients were injected peritumorally with a bimodal tracer (ICG-99mTc-Nanocoll) followed by lymphoscintigraphy and SPECT/CT to define the SNs and their anatomic allocation preoperatively. SNs were detected intraoperatively with a hand-held gamma-probe and a hand-held NIRF camera. In 29 of 30 subjects (97%), all preoperatively defined SNs could be identified intraoperatively using a combination of radioactive and fluorescence guidance. A total of 94 SNs (mean 3, range 1-5) that were both radioactive and fluorescent ex vivo were harvested. Eleven of 94 SNs (12%) could only be identified in vivo using NIRF imaging, and the majority of those were located in level 1 close to the primary tumor. A combined fluorescent and radioactive tracer for SNB is feasible, and the additional use of NIRF imaging may improve the accuracy of SN identification in oral cancer patients. Intraoperative fluorescence guidance seems of particular value when SNs are located in close proximity to the injection site.

Power spectral analysis of the sleep electroencephalogram in heartburn patients with or without gastroesophageal reflux disease: a feasibility study.

PubMed

Budhiraja, Rohit; Quan, Stuart F; Punjabi, Naresh M; Drake, Christopher L; Dickman, Ram; Fass, Ronnie

2010-02-01

Determine the feasibility of using power spectrum of the sleep electroencephalogram (EEG) as a more sensitive tool than sleep architecture to evaluate the relationship between gastroesophageal reflux disease (GERD) and sleep. GERD has been shown to adversely affect subjective sleep reports but not necessarily objective sleep parameters. Data were prospectively collected from symptomatic patients with heartburn. All symptomatic patients underwent upper endoscopy. Patients without erosive esophagitis underwent pH testing. Sleep was polygraphically recorded in the laboratory. Spectral analysis was performed to determine the power spectrum in 4 bandwidths: delta (0.8 to 4.0 Hz), theta (4.1 to 8.0 Hz), alpha (8.1 to 13.0 Hz), and beta (13.1 to 20.0 Hz). Eleven heartburn patients were included in the GERD group (erosive esophagitis) and 6 heartburn patients in the functional heartburn group (negative endoscopy, pH test, response to proton pump inhibitors). The GERD patients had evidence of lower average delta-power than functional heartburn patients. Patients with GERD had greater overall alpha-power in the latter half of the night (3 hours after sleep onset) than functional heartburn patients. No significant differences were noted in conventional sleep stage summaries between the 2 groups. Among heartburn patients with GERD, EEG spectral power during sleep is shifted towards higher frequencies compared with heartburn patients without GERD despite similar sleep architecture. This feasibility study demonstrated that EEG spectral power during sleep might be the preferred tool to provide an objective analysis about the effect of GERD on sleep.

A Novel Form of Breast Intraoperative Radiation Therapy With CT-Guided High-Dose-Rate Brachytherapy: Results of a Prospective Phase 1 Clinical Trial

DOE Office of Scientific and Technical Information (OSTI.GOV)

Showalter, Shayna L., E-mail: snl2t@virginia.edu; Petroni, Gina; Trifiletti, Daniel M.

Purpose: Existing intraoperative radiation therapy (IORT) techniques are criticized for the lack of image guided treatment planning and energy deposition with, at times, poor resultant dosimetry and low radiation dose. We pioneered a novel method of IORT that incorporates customized, computed tomography (CT)-based treatment planning and high-dose-rate (HDR) brachytherapy to overcome these drawbacks: CT-HDR-IORT. Methods and Materials: A phase 1 study was conducted to demonstrate the feasibility and safety of CT-HDR-IORT. Eligibility criteria included age ≥50 years, invasive or in situ breast cancer, tumor size <3 cm, and N0 disease. Patients were eligible before or within 30 days of breast-conserving surgery (BCS). BCSmore » was performed, and a multilumen balloon catheter was placed. CT images were obtained, a customized HDR brachytherapy plan was created, and a dose of 12.5 Gy was delivered to 1-cm depth from the balloon surface. The catheter was removed, and the skin was closed. The primary endpoints were feasibility and acute toxicity. Feasibility was defined as IORT treatment interval (time from CT acquisition until IORT completion) ≤90 minutes. The secondary endpoints included dosimetry, cosmetic outcome, quality of life, and late toxicity. Results: Twenty-eight patients were enrolled. The 6-month follow-up assessments were completed by 93% of enrollees. The median IORT treatment interval was 67.2 minutes (range, 50-108 minutes). The treatment met feasibility criteria in 26 women (93%). The dosimetric goals were met in 22 patients (79%). There were no Radiation Therapy Oncology Group grade 3+ toxicities; 6 patients (21%) experienced grade 2 events. Most patients (93%) had good/excellent cosmetic outcomes at the last follow-up visit. Conclusions: CT-HDR-IORT is feasible and safe. This promising approach for a conformal, image-based, higher-dose breast IORT is being evaluated in a phase 2 trial.« less

A novel implantable device for the treatment of obstructive sleep apnea: clinical safety and feasibility.

PubMed

Pavelec, Vaclav; Rotenberg, Brian W; Maurer, Joachim T; Gillis, Edward; Verse, Thomas

2016-01-01

Many cases of obstructive sleep apnea (OSA) involve collapse of the tongue base and soft palate during sleep, causing occlusion of the upper airway and leading to oxygen desaturation. Existing therapies can be effective, but they are plagued by patient adherence issues and the invasiveness of surgical approaches. A new, minimally invasive implant for OSA has been developed, which is elastic and contracts a few weeks after deployment, stabilizing the surrounding soft tissue. The device has had good outcomes in preclinical testing; this report describes the preliminary feasibility and safety of its implementation in humans. A prospective, multicenter, single-arm feasibility study was conducted. Subjects were adults with moderate-to-severe OSA who had previously failed or refused conventional continuous positive airway pressure treatment. Intraoperative feasibility data, postoperative pain, and safety information were collected for a 30-day postoperative period. Forty subjects participated (37 men, three women; average age of 46.1 years); each received two tongue-base implants and two soft-palate implants. Surgical procedure time averaged 43 minutes. Postsurgical pain resolved readily in most cases; at 30 days post implantation, <20% of subjects reported pain, which averaged less than two out of ten. Adverse events were generally the mild and expected sequelae of a surgical procedure with general anesthesia and intraoral manipulation. The device was well tolerated. Implant extrusions were reported with soft-palate implants (n=12), while tongue-base implants required few revisions (n=2). Quantitative and qualitative sleep effectiveness outcomes (including full-night polysomnographic and quality-of-life measures) will be presented in a subsequent report. Implantation of the device was feasible. Although a relatively high rate of extrusions occurred in the now-discontinued palate implants, tongue-base implants were largely stable and well tolerated. The minimally invasive and maintenance-free implant may provide a new alternative to higher morbidity surgical procedures.

Stapedotomy in osteogenesis imperfecta: a prospective study of 32 consecutive cases.

PubMed

Vincent, Robert; Wegner, Inge; Stegeman, Inge; Grolman, Wilko

2014-12-01

To prospectively evaluate hearing outcomes in patients with osteogenesis imperfecta undergoing primary stapes surgery and to isolate prognostic factors for success. A nonrandomized, open, prospective case series. A tertiary referral center. Twenty-five consecutive patients who underwent 32 primary stapedotomies for osteogenesis imperfecta with evidence of stapes fixation and available postoperative pure-tone audiometry. Primary stapedotomy with vein graft interposition and reconstruction with a regular Teflon piston or bucket handle-type piston. Preoperative and postoperative audiometric evaluation using conventional 4-frequency (0.5, 1, 2, and 4 kHz) audiometry. Air-conduction thresholds, bone-conduction thresholds, and air-bone gap were measured. The overall audiometric results as well as the results of audiometric evaluation at 3 months and at least 1 year after surgery were used. Overall, postoperative air-bone gap closure to within 10 dB was achieved in 88% of cases. Mean (standard deviation) gain in air-conduction threshold was 22 (9.4) dB for the entire case series, and mean (standard deviation) air-bone gap closure was 22 (9.0) dB. Backward multivariate logistic regression showed that a model with preoperative air-bone gap closure and intraoperatively established incus length accurately predicts success after primary stapes surgery. Stapes surgery is a feasible and safe treatment option in patients with osteogenesis imperfecta. Success is associated with preoperative air-bone gap and intraoperatively established incus length.

Implementation of Injury and Illness Surveillance Protocols in Varsity Athletes.

PubMed

Gamble, Alexander Shand Davis; Mountjoy, Margo Lynn; Bigg, Jessica Lynne; Spriet, Lawrence Leon

2018-05-02

To develop and implement a prospective varsity athlete surveillance system to identify injury and illness trends in a multisport varsity-level university setting. Longitudinal prospective surveillance study. Varsity-level sport program at the University of Guelph, Guelph, ON, Canada. Athletic therapists (ATs) (n = 35) from 17 varsity sports provided injury and illness information on 624 varsity-level athletes (381 men and 243 women) during the 2016/2017 competitive season. Team ATs reported athlete health complaints weekly. Athletes reported additional details on the injury or illness that was reported. The outcome measurements included when the injury or illness occurred, anatomical location, diagnosis, cause, perceived severity, treatment, estimated athlete exposure (AE) to training and competition, and time loss from sport. Measures were recorded from the teams' first competition through to end their season and/or playoffs. Twenty-nine of 30 varsity sports teams participated in this injury and illness surveillance protocol. The compliance of team ATs and varsity athletes was 89% (men: 94%, women: 82%). The overall injury and illness rates were 5.5 injuries and 1.7 illnesses per 1000 AEs, respectively. Men's injury rates were greater than women's, and injury rates of contact sports were greater than noncontact sports. The utilization of a prospective injury and illness surveillance protocol in the Canadian University sport system is feasible with good athlete, AT, and coach acceptance. The surveillance data should inform future injury and illness prevention strategies.

Feasibility of assessing the safety and effectiveness of menstrual regulation medications purchased from pharmacies in Bangladesh: a prospective cohort study.

PubMed

Footman, Katharine; Scott, Rachel; Taleb, Fahmida; Dijkerman, Sally; Nuremowla, Sadid; Reiss, Kate; Church, Kathryn

2018-02-01

To assess the feasibility of following up women who purchase mifepristone+misoprostol or misoprostol-only from pharmacies in order to measure the safety and effectiveness of self-administration of menstrual regulation. A prospective cohort study followed women purchasing mifepristone+misoprostol or misoprostol-only from pharmacies in Bangladesh. Participants were recruited by pharmacy workers either in person or indirectly via the purchaser of the drugs. End users were contacted by phone 2 weeks after recruitment, screened and interviewed. Study recruitment rates by pharmacy workers were low (30%, 109 of 642 women informed about the study), but 2-week follow-up rates were high (87%). Of the 109 end users interviewed, 87 purchased mifepristone+misoprostol and 20 misoprostol-only, while 2 women did not know what drugs they had purchased. Mean self-reported number of weeks of pregnancy was 5.7 weeks. Information provision by pharmacy workers was inadequate (40.4% received none, 8.7% received written information or pictures). A total of 80.5% of mifepristone+misoprostol users were sold the correct regimen versus 9 out of 20 misoprostol-only users. A total of 68.8% did not report experiencing any complications (70.0% misoprostol-only; 69.0% mifepristone+misoprostol users, p=1.0). A total of 94.3% of mifepristone+misoprostol users and 75% of misoprostol-only users reported that they were not pregnant at day 15 (p=.020). However, 7.3% of all users sought additional treatment. Challenges in assessing outcomes of self-managed menstrual regulation medications purchased from pharmacies must be overcome through further development of this methodology. Interventions are urgently needed to ensure that women have access to correct dosages, accurate information and necessary referrals. This paper assesses the outcomes of women who self-manage menstrual regulation medications purchased from pharmacies. The methodology requires further development, but our study provides preliminary positive evidence on the safety and effectiveness of self-management despite low information provision from pharmacy workers. Copyright © 2017 The Authors. Published by Elsevier Inc. All rights reserved.

Empowerment-Based Diabetes Self-Management Education to Maintain Glycemic Targets During Ramadan Fasting in People With Diabetes Who Are on Conventional Insulin: A Feasibility Study

PubMed Central

Sahmoud, Sahar I.; Abdelsalam, Mona M.; Eichorst, Barbara

2017-01-01

Objective. This study aims to assess the feasibility of promoting safe Ramadan fasting through diabetes self-management education (DSME) and to determine the effect of such education on hypoglycemic episodes. Design and methods. This prospective study included subjects attending Ramadan reinforcement sessions for participants in the Educational Program for People with Diabetes (EPPWD) at the Ain-Shams University Diabetes Center in Cairo, Egypt. The DSME sessions started 2–3 weeks before Ramadan and included one experimental fasting day during the first week and one during the second week. Participants’ A1C and serum fructosamine levels were measured before and after Ramadan, and they completed weekly self-monitoring of blood glucose (SMBG) logs. Results. Among 21 participants who were intending to fast for Ramadan, 14 completed the program. Their mean A1C was 6.7 ± 1.6%, and SMBG results showed a statistically nonsignificant difference in mean blood glucose levels before and after Ramadan (123.84 ± 39.96 and 123.84 ± 25.92 mg/dL, respectively; P >0.05). Serum fructosamine after Ramadan declined by 10% from pre-Ramadan levels. The mean number of hypoglycemic events before Ramadan was 3 ± 1.04, which declined to 1.4 ± 0.5 during Ramadan. Differences between group 1 (those without hypoglycemia, n = 8) and group 2 (those with hypoglycemia, n = 6) were nonsignificant for all variables, including A1C. Conclusion. Ramadan fasting is feasible for people with diabetes who are on a multiple daily injection insulin regimen and participate in the EPPWD. The number of hypoglycemic events per month declined with the attainment of DSME. PMID:28270713

Beyond height and weight: a programme of school nurse assessed skinfold measurements from white British and South Asian origin children aged 4-5 years within the Born in Bradford cohort study.

PubMed

West, Jane; Santorelli, Gillian; Lennon, Laura; O'Connell, Kathy; Corkett, John; Wright, John; Brierley, Shirley; Whincup, Peter; Cameron, Noel; Lawlor, Debbie A

2015-11-26

To describe the feasibility, reliability and additional information gained from collecting additional body fatness measures (beyond height and weight) from UK reception year children. Prospective cohort study. Bradford, UK. 2458 reception year children participating in the Born in Bradford (BiB) cohort study. The feasibility and reliability of subscapular and triceps skinfold measurements and differences in adiposity between ethnic groups. Of those children who were matched to their school, 91% had a subscapular skinfold measurement and 92% had a triceps skinfold measurement recorded. Reliability was generally over 90% for all measurers and both measurements. Pakistani children were slightly taller but weighed less and had lower triceps skinfold thickness (mean difference -1.8 mm, 95% CI -2.1 to -1.4 mm) but higher subscapular (mean difference 0.1 mm, 95% CI -0.1 to 0.4 mm) than white British children. We have shown that it is feasible for school nurses to collect skinfold measurements in a similar way to the height and weight measurements collected from reception year children for the National Child Measurement Programme (NCMP), and that these measurements are reliable. It is important for healthcare practice to acknowledge ethnic-specific risk and these additional measurements can provide important information to examine population-level risk in populations with large proportions of South Asian children. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

Ultrasound-guided percutaneous tracheostomy in critically ill obese patients

PubMed Central

2012-01-01

Introduction The purpose of this study was to evaluate the feasibility of ultrasound (US)-guided percutaneous tracheostomy (PCT) and the incidence of complications in critically ill, obese patients. Methods Fifty consecutive patients were included in a prospective study in two surgical and critical care medicine departments. Obesity was defined as a body mass index (BMI) of at least 30 kg/m2. The feasibility of PCT and the incidence of complications were compared in obese patients (n = 26) and non-obese patients (n = 24). Results are expressed as the median (25th-75th percentile) or number (percentage). Results The median BMIs were 34 kg/m2 (32-38) in the obese patient group and 25 kg/m2 (24-28) in the non-obese group (p < 0.001). The median times for tracheostomy were 10 min (8-14) in non-obese patients and 9 min (5-10) in obese-patients (p = 0.1). The overall complication rate was similar in obese and non-obese patient groups (35% vs. 33%, p = 0.92). Most complications were minor (hypotension, desaturation, tracheal cuff puncture and minor bleeding), with no differences between obese and non-obese groups. Bronchoscopic inspection revealed two cases of granuloma (8%) in obese patients. One non-obese patient developed a peristomal skin infection, which was treated with intravenous antibiotics. Ultrasound-guided PCT was possible in all enrolled patients and there were no surgical conversions or deaths. Conclusions This study demonstrated that US-guided PCT is feasible in obese patients with a low complication rate. Obesity may not constitute a contra-indication for US-guided PCT. A US examination provides information on cervical anatomy and hence modifies and guides choice of the PCT puncture site. Trial registration ClinicalTrials.gov: NCT01502657. PMID:22390815

Ultrasound-guided percutaneous tracheostomy in critically ill obese patients.

PubMed

Guinot, Pierre-Grégoire; Zogheib, Elie; Petiot, Sandra; Marienne, Jean-Pierre; Guerin, Anne-Marie; Monet, Pauline; Zaatar, Rody; Dupont, Hervé

2012-12-12

The purpose of this study was to evaluate the feasibility of ultrasound (US)-guided percutaneous tracheostomy (PCT) and the incidence of complications in critically ill, obese patients. Fifty consecutive patients were included in a prospective study in two surgical and critical care medicine departments. Obesity was defined as a body mass index (BMI) of at least 30 kg/m². The feasibility of PCT and the incidence of complications were compared in obese patients (n = 26) and non-obese patients (n = 24). Results are expressed as the median (25th-75th percentile) or number (percentage). The median BMIs were 34 kg/m² (32-38) in the obese patient group and 25 kg/m² (24-28) in the non-obese group (p < 0.001). The median times for tracheostomy were 10 min (8-14) in non-obese patients and 9 min (5-10) in obese-patients (p = 0.1). The overall complication rate was similar in obese and non-obese patient groups (35% vs. 33%, p = 0.92). Most complications were minor (hypotension, desaturation, tracheal cuff puncture and minor bleeding), with no differences between obese and non-obese groups. Bronchoscopic inspection revealed two cases of granuloma (8%) in obese patients. One non-obese patient developed a peristomal skin infection, which was treated with intravenous antibiotics. Ultrasound-guided PCT was possible in all enrolled patients and there were no surgical conversions or deaths. This study demonstrated that US-guided PCT is feasible in obese patients with a low complication rate. Obesity may not constitute a contra-indication for US-guided PCT. A US examination provides information on cervical anatomy and hence modifies and guides choice of the PCT puncture site. ClinicalTrials.gov: NCT01502657.

A technology-enabled adherence enhancement system for people with bipolar disorder: results from a feasibility and patient acceptance analysis

PubMed Central

Sajatovic, Martha; Davis, Michael S; Cassidy, Kristin A; Nestor, Joseph; Sams, Johnny; Fuentes-Casiano, Edna

2015-01-01

Objective As poor medication adherence is common in bipolar disorder (BD), technology-assisted approaches may help to monitor and enhance adherence. This study evaluated preliminary feasibility, patient satisfaction and effects on adherence, BD knowledge, and BD symptoms associated with the use of a multicomponent technology-assisted adherence enhancement system. Methods This prospective study tested the system in five BD patients over a 15-day period. System components included: 1) an automated pill cap with remote monitoring sensor; 2) a multimedia adherence enhancement program; and 3) a treatment incentive program. This study evaluated system usability, patient satisfaction and effects on adherence (Morisky scale), knowledge (treatment knowledge test [TKT]), and symptoms (internal state scale [ISS]). Results Mean age of the sample was 62 years, 4/5 (80%) Caucasian, and 4/5 (80%) single/divorced or widowed. Most participants (4/5, 80%) were on a single BD medication. Participants had BD for an average of 21 years. Challenges included attaching the pill sensor to standard pharmacy bottles for individuals using very large pill containers or those with multiday pill boxes. Three of five (60%) individuals completed the full 15-day period. Usability scores were high overall. Mean Morisky scores improved. Means on all four subscales of the ISS were all in the direction of improvement. On the TKT, there was a 40% increase in mean scores. Conclusion A multicomponent technology-assisted BD adherence enhancement system is feasible. Challenges include accommodating multiple types of pill containers and monitoring multiple drugs simultaneously. The system can also generate adherence information that is potentially useful for treatment planning. PMID:26089652

Feasibility and toxicity of concomitant radio/immunotherapy with MabThera (Rituximab®) for patients with non-Hodkin's Lymphoma: results of a prospective phase I/II study.

PubMed

Haidenberger, Alfred; Fromm-Haidenberger, Sabine; de Vries, Alexander; Popper, Bela-Andre; Steurer, Michael; Skvortsova, Ira; Kantner, Johanna; Gunsilius, Eberhard; Lukas, Peter

2011-05-01

Non-Hodgkin's lymphomas (NHL) have a high radio- and chemosensitivity. Although initially responsive, approximately 50% of low grade B-cell lymphomas relapse after 10-15 years. Besides chemo- and radiotherapy, rituximab, a mouse/human chimeric antibody targeting CD20 antigen on the surface of B-cell lymphoma cells, is another treatment approach. In vitro data showed potentiation of radiation-induced apoptosis by addition of rituximab. The purpose of this study was to evaluate the feasibility and toxicity of radiotherapy with concomitant application of rituximab in NHL patients. A total of 21 patients with B-cell lymphoma (stage I: n = 11; II: n = 5; III: n = 1; IV: n = 4) were included in this study, treated with radiotherapy of 30-40 Gy and weekly application of rituximab (375 mg/m²). Nine patients had R-CHOP chemotherapy previously, 1 patient leuceran chemotherapy, and 2 patients an initial treatment with 6 cycles of rituximab. Mean time of follow-up was 41.7 months. No grade 4 toxicity or treatment-related death was observed. In 1 patient, rituximab application had to be stopped after 3 cycles due to radiation-induced side effects. No late toxicities were reported. All patients were in complete remission after treatment. Progression or relapse was observed in 6 patients (28%); the mean time to progression was 27 months. The mean overall survival (OS) was 53 months. Combined radio/immunotherapy is feasible and safe. Treatment was well tolerated, no late toxicities were observed, and treatment outcome is promising. Randomized trials are necessary to clarify the benefit of this treatment approach and its applicability.

Assessing the feasibility, acceptability, and potential effectiveness of a behavioral-automaticity focused lifestyle intervention for African Americans with metabolic syndrome: The Pick two to Stick to protocol.

PubMed

Fritz, Heather; Brody, Aaron; Levy, Philip

2017-09-01

Metabolic syndrome (MetS) significantly increases the risk of developing diabetes and cardiovascular disease. Being physically active and eating a healthy diet can reduce MetS risk factors. Too frequently, however, studies report that the effects of interventions targeting those factors are not maintained once interventions are withdrawn. A potential solution to the problem is targeting behavioral automaticity (habit-development) to aid in initiation and maintenance of health-behavior changes. The Pick two to Stick To (P2S2), is an 8-week, theory-based hybrid (face-to-face/telecoaching) habit focused lifestyle intervention designed to increase healthful physical activity and dietary behavioral automaticity. The purpose of this article is to describe the rationale and protocol for evaluating the P2S2 program's feasibility, acceptability and potential effectiveness. Using a prospective, non-comparative design, the P2S2 program will be implemented by trained occupational therapy 'coaches' to 40 African Americans aged 40 and above with MetS recruited from the emergency department. Semi-structured interviews with participants, bi-weekly research meetings with study staff, and observations of intervention delivery will provide data for a process evaluation. Estimates of effectiveness include weight, blood pressure, waist circumference, BMI, and behavioral automaticity measures that will be collected at baseline and week 20. The P2S2 program could facilitate the development of healthful dietary and physical activity habits in an underserved population. Whether interventions aimed at changing habits can feasibly influence this automaticity, particularly for high-risk, low resource communities where other barriers exist, is not known. This pilot study, therefore, will fill an important gap, providing insight to inform subsequent trials.

Bio-sheet graft therapy for artificial gastric ulcer after endoscopic submucosal dissection: an animal feasibility study.

PubMed

Kwon, Chang-Il; Kim, Gwangil; Ko, Kwang Hyun; Jung, Yunho; Chung, Il-Kwun; Jeong, Seok; Lee, Don Haeng; Hong, Sung Pyo; Hahm, Ki Baik

2015-04-01

Various bio-sheet grafts have been attempted either to accelerate healing of artificial ulcers or to prevent adverse events after endoscopic submucosal dissection (ESD), but neither prospective nor mechanistic studies were available. To evaluate the substantial effect of a bio-sheet graft on artificial ulcer healing and its feasibility as an endoscopic treatment modality. Preclinical, in vivo animal experiment and proof-of-concept study. Animal laboratory. Three mini-pigs, Sus scrofa, mean age 14 months. Multiple ulcers sized 2.5 cm in diameter were generated by ESD in 3 mini-pigs and were assigned randomly into the following 3 groups; control group, bio-sheet group, or combination (bio-sheet plus drug) group. Bio-sheet grafts or bio-sheet plus drug combinations were applied on the artificial ulcers immediately after the ESD. Feasibility and efficacy of endoscopic bio-sheet graft therapy for the management of artificial ulcers and the evaluation of healing conditions based on histology changes in the remaining gastric bed tissues harvested from the stomachs. Thirty-three ESD specimens were obtained. On an image analysis of the ratio of healed area in the remaining gastric bed tissue compared with the matched dissected gastric mucosa, the control group showed the most significant improvement in healing activity among the 3 groups (P < .05), whereas the severity of inflammation in the remaining ulcer tissue was significantly attenuated in bio-sheet and combination groups (P < .05). Animal model. Although the bio-sheet grafts provided physical protection from gastric acid attack as reflected in the attenuated inflammation on the ulcer beds, unexpected delayed ulcer healing was noted in the bio-sheet graft group because of its physical hindrance of the healing process. Copyright © 2015 American Society for Gastrointestinal Endoscopy. Published by Elsevier Inc. All rights reserved.

Reliability, validity and feasibility of nail ultrasonography in psoriatic arthritis.

PubMed

Arbault, Anaïs; Devilliers, Hervé; Laroche, Davy; Cayot, Audrey; Vabres, Pierre; Maillefert, Jean-Francis; Ornetti, Paul

2016-10-01

To determine the feasibility, reliability and validity of nails ultrasonography in psoriatic arthritis as an outcome measure. Pilot prospective single-centre study of eight ultrasonography parameters in B mode and power Doppler concerning the distal interphalangeal (DIP) joint, the matrix, the bed and nail plate. Intra-observer and inter-observer reliability was evaluated for the seven quantitative parameters (ICC and kappa). Correlations between ultrasonography and clinical variables were searched to assess external validity. Feasibility was assessed by the time to carry out the examination and the percentage of missing data. Twenty-seven patients with psoriatic arthritis (age 55.0±16.2 years, disease duration 13.4±9.4 years) were included. Of these, 67% presented nail involvement on ultrasonography vs 37% on physical examination (P<0.05). Reliability was good (ICC and weighted kappa>0.75) for the seven quantitative parameters, except for synovitis of the DIP joint in B mode. The synovitis of the DIP joint revealed by ultrasonography correlated with the total number of clinical synovitis and Doppler US of the nail (matrix and bed). Doppler US of the matrix correlated with VAS pain but not with the ASDAS-CRP or with clinical enthesitis. No significant correlation was found with US nail thickness. The feasibility and reliability of ultrasonography of the nail in psoriatic arthritis appear to be satisfactory. Among the eight parameters evaluated, power Doppler of the matrix which correlated with local inflammation (DIP joint and bed) and with VAS pain could become an interesting outcome measure, provided that it is also sensitive to change. Copyright © 2015 Société française de rhumatologie. Published by Elsevier SAS. All rights reserved.

Three-dimensional Image Fusion Guidance for Transjugular Intrahepatic Portosystemic Shunt Placement.

PubMed

Tacher, Vania; Petit, Arthur; Derbel, Haytham; Novelli, Luigi; Vitellius, Manuel; Ridouani, Fourat; Luciani, Alain; Rahmouni, Alain; Duvoux, Christophe; Salloum, Chady; Chiaradia, Mélanie; Kobeiter, Hicham

2017-11-01

To assess the safety, feasibility and effectiveness of image fusion guidance with pre-procedural portal phase computed tomography with intraprocedural fluoroscopy for transjugular intrahepatic portosystemic shunt (TIPS) placement. All consecutive cirrhotic patients presenting at our interventional unit for TIPS creation from January 2015 to January 2016 were prospectively enrolled. Procedures were performed under general anesthesia in an interventional suite equipped with flat panel detector, cone-beam computed tomography (CBCT) and image fusion technique. All TIPSs were placed under image fusion guidance. After hepatic vein catheterization, an unenhanced CBCT acquisition was performed and co-registered with the pre-procedural portal phase CT images. A virtual path between hepatic vein and portal branch was made using the virtual needle path trajectory software. Subsequently, the 3D virtual path was overlaid on 2D fluoroscopy for guidance during portal branch cannulation. Safety, feasibility, effectiveness and per-procedural data were evaluated. Sixteen patients (12 males; median age 56 years) were included. Procedures were technically feasible in 15 of the 16 patients (94%). One procedure was aborted due to hepatic vein catheterization failure related to severe liver distortion. No periprocedural complications occurred within 48 h of the procedure. The median dose-area product was 91 Gy cm 2 , fluoroscopy time 15 min, procedure time 40 min and contrast media consumption 65 mL. Clinical benefit of the TIPS placement was observed in nine patients (56%). This study suggests that 3D image fusion guidance for TIPS is feasible, safe and effective. By identifying virtual needle path, CBCT enables real-time multiplanar guidance and may facilitate TIPS placement.

Acceptability and Feasibility of a Mobile Phone-Based Case Management Intervention to Retain Mothers and Infants from an Option B+ Program in Postpartum HIV Care.

PubMed

Schwartz, Sheree R; Clouse, Kate; Yende, Nompumelelo; Van Rie, Annelies; Bassett, Jean; Ratshefola, Mamothe; Pettifor, Audrey

2015-09-01

The objective of this study was to assess the acceptability and feasibility of a cell phone based case manager intervention targeting HIV-infected pregnant women on highly-active antiretroviral therapy (HAART). Pregnant women ≥36 weeks gestation attending antenatal care and receiving HAART through the Option B+ program at a primary care clinic in South Africa were enrolled into a prospective pilot intervention to receive text messages and telephone calls from a case manager through 6 weeks postpartum. Acceptability and feasibility of the intervention were assessed along with infant HIV testing rates and 10-week and 12-month postpartum maternal retention in care. Retention outcomes were compared to women of similar eligibility receiving care prior to the intervention. Fifty women were enrolled into the pilot from May to July 2013. Most (70%) were HAART-naive at time of conception and started HAART during antenatal care. During the intervention, the case manager sent 482 text messages and completed 202 telephone calls, for a median of 10 text messages and 4 calls/woman. Ninety-six percent completed the postpartum interview and 47/48 (98%) endorsed the utility of the intervention. Engagement in 10-week postpartum maternal HIV care was >90% in the pre-intervention (n = 50) and intervention (n = 50) periods; by 12-months retention fell to 72% and was the same across periods. More infants received HIV-testing by 10-weeks in the intervention period as compared to pre-intervention (90.0 vs. 63.3%, p < 0.01). Maternal support through a cell phone based case manager approach was highly acceptable among South African HIV infected women on HAART and feasible, warranting further assessment of effectiveness.

Exercise-based pre-habilitation is feasible and effective in radical cystectomy pathways-secondary results from a randomized controlled trial.

PubMed

Jensen, Bente Thoft; Laustsen, Sussie; Jensen, Jørgen Bjerggaard; Borre, Michael; Petersen, Annemette Krintel

2016-08-01

Physical exercises offer a variety of health benefits to cancer survivors during and post-treatment. However, exercise-based pre-habilitation is not well reported in major uro-oncology surgery. The aim of this study was to investigate the feasibility, the adherence, and the efficacy of a short-term physical pre-habilitation program to patients with invasive bladder cancer awaiting radical cystectomy (RC). A parent prospective randomized controlled clinical trial investigated efficacy of a multidisciplinary rehabilitation program on length of stay following RC. A total of 107 patients were included in the intension-to-treat population revealing 50 patients in the intervention group and 57 patients in the standard group. Pre-operatively, the intervention group was instructed to a standardized exercise program consisting of both muscle strength exercises and endurance training. The number of training sessions and exercise repetitions was patient-reported. Feasibility was expressed as adherence to the program and efficacy as the differences in muscle power within and between treatment groups at time for surgery. A total of 66 % (95 % confidence interval (CI) 51; 78) adhered more than 75 % of the recommended progressive standardized exercise program. In the intervention group, a significant improvement in muscle power of 18 % (p < 0.002) was found at time for surgery. Moreover, muscle power was significantly improved compared to that in the standard group with 0.3 W/kg (95 % CI 0.08; 0.5 %) (p < 0.006). Adherence was not associated with pre-operative BMI, nutritional risk, comorbidity, pain, gender, or age. In patients awaiting RC, a short-term exercise-based pre-habilitation intervention is feasible and effective and should be considered in future survivorship strategies.

Clinical Trials Network / Building Infrastructure to Accelerate Transfer of Basic Research in Spinal Cord Injury (SCI) to Clinical Practice

DTIC Science & Technology

2015-05-01

Glasgow Coma Scale (GCS) and of associated injuries with the Abbreviated Injury Scale . The American Spinal Injury Association impairment scale (AIS) is...registry protocol includes: the AIS Impairment Scale , and where appropriate, the Functional Independence Measure FIM™, the Spinal Cord Independence...have been achieved with the registry. Enrollment of 762 participants has demonstrated that is feasible to acquire prospective standardized research

Fluorescent probes for real-time measurement of nitric oxide in living cells.

PubMed

Li, Huili; Wan, Ajun

2015-11-07

Nitric oxide (NO) is an important signaling molecule in biology. Both NO excess and insufficiency have been implicated in numerous physiological and pathological conditions. In order to study the diverse biological roles of NO in cells and tissues, many techniques have been developed for assaying NO. Recently, new generations of fluorescent probes have become indispensible tools for the study of NO biology because of their sensitivity, selectivity, spatiotemporal resolution, and experimental feasibility. Rational application of these probes in the study requires the understanding of the molecular mechanism that the probes are involved in. In this review, we will present an arsenal of fluorescent probes used to detect NO in living cells and animal tissues. We will also discuss the molecular mechanisms, actualities and prospects of fluorescent probes in detecting NO in cell biology.

Effect of kangaroo mother care on postpartum depression.

PubMed

de Alencar, Andréa Echeverria Martins Arraes; Arraes, Luis Cláudio; de Albuquerque, Emídio Cavalcanti; Alves, João Guilherme Bezerra

2009-02-01

Postpartum depression (PPD) is a serious public health issue. Kangaroo mother care (KMC) is widely considered to be the most feasible, readily available and preferred intervention for decreasing neonatal morbidity and mortality in developing countries. We conducted a prospective study to assess the effect of KMC on PPD. The study population included 177 low-income mothers with their preterm infants. We used the validated Portuguese version of the Postpartum Depression Screening Scale for the assessment of maternal depression. The mothers were evaluated twice, at Neonatal Intensive Care Unit admission and at KMC discharge. We found 66 mothers (37.3%) with depression and it decreased to 30 (16.9%) after KMC intervention; p < 0.0001. None developed PPD during the Kangaroo stay. We concluded that KMC may lessen maternal depression. Further studies, may be required to clarify these preliminary findings.

Endoscopy/EUS-guided fiducial marker placement in patients with esophageal cancer: a comparative analysis of 3 types of markers.

PubMed

Machiels, Melanie; van Hooft, Jeanin; Jin, Peng; van Berge Henegouwen, Mark I; van Laarhoven, Hanneke M; Alderliesten, Tanja; Hulshof, Maarten C

2015-10-01

Markers placed at the borders of esophageal tumors are potentially useful to facilitate radiotherapy (RT) target delineation, which offers the possibility of image-guided RT. To evaluate and compare the feasibility and technical benefit of endoscopy/EUS-guided marker placement of 3 different types of markers in patients with esophageal cancer referred for RT. Prospective, single-center, feasibility and comparative study. Tertiary-care medical center. Thirty patients with esophageal cancer who were referred for RT. Patients underwent endoscopy/EUS-guided implantation of 1 type of marker. A solid gold marker (SM) with fixed dimensions, a flexible coil-shaped gold marker (FM) with hand-cut length (2-10 mm), and a radiopaque hydrogel marker (HG) were used. Technical feasibility and adverse events were registered. CT scans and cone-beam CT scans (CBCT) acquired during RT were analyzed to determine and compare the visibility and continuous clear visibility of the implanted markers. Technical feasibility, technical benefit, and adverse events of 3 types of markers. A total of 101 markers were placed in 30 patients. Implantation was technically feasible in all patients without grade 3 to 4 adverse events. Two patients with asymptomatic mediastinitis and one with asymptomatic pneumothorax were seen. Visibility on CT scan of all 3 types of implanted markers was adequate for target delineation. Eighty percent of FMs remained continuously visible over the treatment period on CBCT, significantly better than SMs (63%) and HGs (11%) (P = .015). When we selected FMs ≥5 mm, 90.5% remained visible on CBCT between implantation and the end of RT. Single-center, nonrandomized design. Endoscopy/EUS-guided fiducial marker placement for esophageal cancer is both safe and feasible and can be used for target volume delineation purposes on CT. Our results imply a significant advantage of FMs over SMs and HGs, regarding visibility and continuous clear visibility over the treatment period. ( NTR4724.). Copyright © 2015 American Society for Gastrointestinal Endoscopy. Published by Elsevier Inc. All rights reserved.

Twelve-month short-term safety and visual-acuity results from a multicentre prospective study of epiretinal strontium-90 brachytherapy with bevacizumab for the treatment of subfoveal choroidal neovascularisation secondary to age-related macular degeneration.

PubMed

Avila, M P; Farah, M E; Santos, A; Duprat, J P; Woodward, B W; Nau, J

2009-03-01

This study evaluated the short-term safety and feasibility of epiretinal strontium-90 brachytherapy delivered concomitantly with intravitreal bevacizumab for the treatment of subfoveal CNV due to AMD for 12 months. A 3-year follow-up is planned. In this prospective, non-randomised, multicentre study, 34 treatment-naïve patients with predominantly classic, minimally classic and occult subfoveal CNV lesions received a single treatment with 24 Gy beta radiation (strontium-90) and two injections of the anti-VEGF antibody bevacizumab. Adverse events were observed. BCVA was measured using standard ETDRS vision charts. Twelve months after treatment, no radiation-associated adverse events were observed. In the intent-to-treat (ITT) population, 91% of patients lost <3 lines (15 ETDRS letters) of vision at 12 months, 68% improved or maintained their BCVA at 12 months, and 38% gained >/=3 lines. The mean change in BCVA observed at month 12 was a gain of 8.9 letters. The safety and efficacy of intraocular, epiretinal brachytherapy delivered concomitantly with anti-VEGF therapy for the treatment of subfoveal CNV secondary to AMD were promising in this small study population. Long-term safety will be assessed for 3 years. This regimen is being evaluated in a large, multicentre, phase III study.

Three-Dimensional Rotation, Twist and Torsion Analyses Using Real-Time 3D Speckle Tracking Imaging: Feasibility, Reproducibility, and Normal Ranges in Pediatric Population.

PubMed

Zhang, Li; Zhang, Jing; Han, Wei; Gao, Jun; He, Lin; Yang, Yali; Yin, Ping; Xie, Mingxing; Ge, Shuping

2016-01-01

The specific aim of this study was to evaluate the feasibility, reproducibility and maturational changes of LV rotation, twist and torsion variables by real-time 3D speckle-tracking echocardiography (RT3DSTE) in children. A prospective study was conducted in 347 consecutive healthy subjects (181 males/156 females, mean age 7.12 ± 5.3 years, and range from birth to 18-years) using RT 3D echocardiography (3DE). The LV rotation, twist and torsion measurements were made off-line using TomTec software. Manual landmark selection and endocardial border editing were performed in 3 planes (apical "2"-, "4"-, and "3"- chamber views) and semi-automated tracking yielded LV rotation, twist and torsion measurements. LV rotation, twist and torsion analysis by RT 3DSTE were feasible in 307 out of 347 subjects (88.5%). There was no correlation between rotation or twist and age, height, weight, BSA or heart rate, respectively. However, there was statistically significant, but very modest correlation between LV torsion and age (R2 = 0.036, P< 0.001). The normal ranges were defined for rotation and twist in this cohort, and for torsion for each age group. The intra-observer and inter-observer variabilities for apical and basal rotation, twist and torsion ranged from 7.3% ± 3.8% to 12.3% ± 8.8% and from 8.8% ± 4.6% to 15.7% ± 10.1%, respectively. We conclude that analysis of LV rotation, twist and torsion by this new RT3D STE is feasible and reproducible in pediatric population. There is no maturational change in rotation and twist, but torsion decreases with age in this cohort. Further refinement is warranted to validate the utility of this new methodology in more sensitive and quantitative evaluation of congenital and acquired heart diseases in children.

An adapted, four-week mind-body skills group for medical students: reducing stress, increasing mindfulness, and enhancing self-care.

PubMed

Greeson, Jeffrey M; Toohey, Michael J; Pearce, Michelle J

2015-01-01

Despite the well-known stress of medical school, including adverse consequences for mental and behavioral health, there is little consensus about how to best intervene in a way that accommodates students׳ intense training demands, interest in science, and desire to avoid being stigmatized. The objective of this study, therefore, was to evaluate the feasibility, acceptability, and initial effectiveness of an adapted, four-week stress management and self-care workshop for medical students, which was based on the science and practice of mind-body medicine. The current study used a prospective, observational, and mixed methods design, with pretest and posttest evaluations. Participants (n = 44) included medical and physician-scientist (MD/PhD) students from a large, southeastern medical school. Feasibility was assessed by rates of workshop enrollment and completion. Acceptability was assessed using qualitative ratings and open-ended responses that queried perceived value of the workshop. Quantitative outcomes included students׳ ratings of stress and mindfulness using validated self-report surveys. Enrollment progressively increased from 6 to 15 to 23 students per workshop in 2007, 2009, and 2011, respectively. Of the 44 enrolled students, 36 (82%) completed the workshop, indicating that the four-session extracurricular format was feasible for most students. Students reported that the workshop was acceptable, stating that it helped them cope more skillfully with the stress and emotional challenges of medical school, and helped increase self-care behaviors, such as exercise, sleep, and engaging in social support. Students also reported a 32% decrease in perceived stress (P < .001; d = 1.38) and a 16% increase in mindfulness (P < .001; d = 0.92) following the workshop. Changes in stress and mindfulness were significantly correlated (r = -0.42; P = .01). Together, these findings suggest that a brief, voluntary mind-body skills workshop specifically adapted for medical students is feasible, acceptable, and effective for reducing stress, increasing mindfulness, and enhancing student self-care. Copyright © 2015 Elsevier Inc. All rights reserved.

Feasibility of a novel remote daily monitoring system for age-related macular degeneration using mobile handheld devices: results of a pilot study.

PubMed

Kaiser, Peter K; Wang, Yi-Zhong; He, Yu-Guang; Weisberger, Annemarie; Wolf, Stephane; Smith, Craig H

2013-10-01

This pilot study evaluated the feasibility of the Health Management Tool (HMT), a novel computing system using mobile handheld devices, to remotely monitor retinal visual function daily in patients with neovascular age-related macular degeneration treated with ranibizumab. Patients with neovascular age-related macular degeneration in at least 1 eye (newly diagnosed or successfully treated < 1 year) and eligible for ranibizumab therapy were enrolled in this 16-week, prospective, open-label, single-arm study. Patients performed a shape discrimination hyperacuity test (myVisionTrack [mVT]) daily on the HMT device (iPhone 3GS) remotely and at all clinic visits. Data entered into HMT devices were collected in the HMT database, which also sent reminders for patients to take mVT. Among 160 patients from 24 U.S. centers enrolled in the study (103 [64%] ≥ 75 years of age), 84.7% on average complied with daily mVT testing and ≈ 98.9% complied with at least weekly mVT testing. The HMT database successfully uploaded more than 17,000 mVT assessment values and sent more than 9,000 reminders. Elderly patients with neovascular age-related macular degeneration were willing and able to comply with daily self-testing of retinal visual function using mobile handheld devices in this novel system of remote vision monitoring.

Model-based iterative reconstruction in low-dose CT colonography-feasibility study in 65 patients for symptomatic investigation.

PubMed

Vardhanabhuti, Varut; James, Julia; Nensey, Rehaan; Hyde, Christopher; Roobottom, Carl

2015-05-01

To compare image quality on computed tomographic colonography (CTC) acquired at standard dose (STD) and low dose (LD) using filtered-back projection, adaptive statistical iterative reconstruction, and model-based iterative reconstruction (MBIR) techniques. A total of 65 symptomatic patients were prospectively enrolled for the study and underwent STD and LD CTC with filtered-back projection, adaptive statistical iterative reconstruction, and MBIR to allow direct per-patient comparison. Objective image noise, subjective image analyses, and polyp detection were assessed. Objective image noise analysis demonstrates significant noise reduction using MBIR technique (P < .05) despite being acquired at lower doses. Subjective image analyses were superior for LD MBIR in all parameters except visibility of extracolonic lesions (two-dimensional) and visibility of colonic wall (three-dimensional) where there were no significant differences. There was no significant difference in polyp detection rates (P > .05). Doses: LD (dose-length product, 257.7), STD (dose-length product, 483.6). LD MBIR CTC objectively shows improved image noise using parameters in our study. Subjectively, image quality is maintained. Polyp detection shows no significant difference but because of small numbers needs further validation. Average dose reduction of 47% can be achieved. This study confirms feasibility of using MBIR in this context of CTC in symptomatic population. Copyright © 2015 AUR. Published by Elsevier Inc. All rights reserved.

Pulse pressure variation-guided fluid therapy after cardiac surgery: a pilot before-and-after trial.

PubMed

Suzuki, Satoshi; Woinarski, Nicholas C Z; Lipcsey, Miklos; Candal, Cristina Lluch; Schneider, Antoine G; Glassford, Neil J; Eastwood, Glenn M; Bellomo, Rinaldo

2014-12-01

The aim of this study is to study the feasibility, safety, and physiological effects of pulse pressure variation (PPV)-guided fluid therapy in patients after cardiac surgery. We conducted a pilot prospective before-and-after study during mandatory ventilation after cardiac surgery in a tertiary intensive care unit. We introduced a protocol to deliver a fluid bolus for a PPV≥13% for at least >10 minutes during the intervention period. We studied 45 control patients and 53 intervention patients. During the intervention period, clinicians administered a fluid bolus on 79% of the defined PPV trigger episodes. Median total fluid intake was similar between 2 groups during mandatory ventilation (1297 mL [interquartile range 549-1968] vs 1481 mL [807-2563]; P=.17) and the first 24 hours (3046 mL [interquartile range 2317-3982] vs 3017 mL [2192-4028]; P=.73). After adjusting for several baseline factors, PPV-guided fluid management significantly increased fluid intake during mandatory ventilation (P=.004) but not during the first 24 hours (P=.47). Pulse pressure variation-guided fluid therapy, however, did not significantly affect hemodynamic, renal, and metabolic variables. No serious adverse events were noted. Pulse pressure variation-guided fluid management was feasible and safe during mandatory ventilation after cardiac surgery. However, its advantages may be clinically small. Copyright © 2014 Elsevier Inc. All rights reserved.

Coffee Enema for Preparation for Small Bowel Video Capsule Endoscopy: A Pilot Study

PubMed Central

Kim, Eun Sun; Keum, Bora; Seo, Yeon Seok; Jeen, Yoon Tae; Lee, Hong Sik; Um, Soon Ho; Kim, Chang Duck; Ryu, Ho Sang

2014-01-01

Coffee enemas are believed to cause dilatation of bile ducts and excretion of bile through the colon wall. Proponents of coffee enemas claim that the cafestol palmitate in coffee enhances the activity of glutathione S-transferase, an enzyme that stimulates bile excretion. During video capsule endoscopy (VCE), excreted bile is one of the causes of poor preparation of the small bowel. This study aimed to evaluate the feasibility and effect of coffee enema for preparation of the small bowel during VCE. In this pilot study, 17 of 34 patients were assigned to the coffee enema plus polyethylene glycol (PEG) 2 L ingestion group, whereas the 17 remaining control patients received 2 L of PEG only. The quality of bowel preparation was evaluated in the two patient groups. Bowel preparations in the proximal segments of small bowel were not differ between two groups. In the mid and distal segments of the small intestine, bowel preparations tend to be better in patients who received coffee enemas plus PEG than in patients who received PEG only. The coffee enema group did not experience any complications or side effects. Coffee enemas may be a feasible option, and there were no clinically significant adverse events related to coffee enemas. More prospective randomized studies are warranted to improve small bowel preparation for VCE. PMID:25136541

[Creation of a complete organised care network allowing facilitated access to ophthalmological care for patients living in socially "at-risk" situations, feasibility study].

PubMed

Terrier de la Chaise, S; Criton, A; Berrod, J-P; Boivin, J-M

2017-09-01

Currently, renouncement to healthcare by socially "at-risk" patients continues to increase and access to ophthalmological care is complex. The main objective of this study is to test the feasibility of a complete organised care network allowing facilitated access to ophthalmological care for patients living in socially "at-risk" situations. A prospective interventional study was conducted within four social housing infrastructures to screen for vision problems in the "at-risk" socially population in question. Partnering with the ophthalmological department of the CHRU de Nancy, an interventional and supportive care trial for the affected population was conducted with the assistance of social workers, nursing aides, opticians, and the author. Ten screening sessions were conducted between December 2015 and April 2016 allowing a vision exam of sixty-five patients living in social housing. Twenty-five patients benefited from specialised care within a three-month time frame provided by the ophthalmological department, of which nineteen patients received corrective lenses. The remaining six patients received other types of ophthalmological care. The study allowed to demonstrate that the cooperation of willing actors makes it possible to improve access to visual healthcare for patients living in socially "at-risk" situations, in particular in the frame of ophthalmological care, often taking second place in a general medical consultation. Copyright © 2017 Elsevier Masson SAS. All rights reserved.

Pacemaker recycling: A notion whose time has come.

PubMed

Runge, Mason W; Baman, Timir S; Davis, Sheldon; Weatherwax, Kevin; Goldman, Ed; Eagle, Kim A; Crawford, Thomas C

2017-04-26

The purpose of this paper is to summarize the need, feasibility, safety, legality, and ethical perspectives of pacemaker reutilization in low- and middle-income countries (LMICs). It will also describe, in-depth, Project My Heart Your Heart (PMHYH) as a model for pacemaker reuse in LMICs. The primary source of the discussion points in this paper is a collection of 14 publications produced by the research team at the University of Michigan and its collaborative partners. The need for pacemaker reutilization in LMICs is evident. Numerous studies show that the concept of pacemaker reutilization in LMICs is feasible. Infection and device malfunction are the main concerns in regard to pacemaker reutilization, yet many studies have shown that pacemaker reuse is not associated with increased infection risk or higher mortality compared with new device implantation. Under the right circumstances, the ethical and legal bases for pacemaker reutilization are supported. PMHYH is a proof of concept pacemaker donation initiative that has allowed funeral home and crematory directors to send explanted devices to an academic center for evaluation and re-sterilization before donation to underserved patients in LMICs. The time is now to pursue large-scale studies and trials of pacemaker reuse for the betterment of society. PMHYH is leading the way in the effort and is poised to conduct a prospective randomized, non-inferiority, multicenter study to confirm the clinical efficacy and safety of pacemaker reuse, for clinical and legal support.

Prospective Molecular Profiling of Canine Cancers Provides a Clinically Relevant Comparative Model for Evaluating Personalized Medicine (PMed) Trials

PubMed Central

Mazcko, Christina; Cherba, David; Hendricks, William; Lana, Susan; Ehrhart, E. J.; Charles, Brad; Fehling, Heather; Kumar, Leena; Vail, David; Henson, Michael; Childress, Michael; Kitchell, Barbara; Kingsley, Christopher; Kim, Seungchan; Neff, Mark; Davis, Barbara

2014-01-01

Background Molecularly-guided trials (i.e. PMed) now seek to aid clinical decision-making by matching cancer targets with therapeutic options. Progress has been hampered by the lack of cancer models that account for individual-to-individual heterogeneity within and across cancer types. Naturally occurring cancers in pet animals are heterogeneous and thus provide an opportunity to answer questions about these PMed strategies and optimize translation to human patients. In order to realize this opportunity, it is now necessary to demonstrate the feasibility of conducting molecularly-guided analysis of tumors from dogs with naturally occurring cancer in a clinically relevant setting. Methodology A proof-of-concept study was conducted by the Comparative Oncology Trials Consortium (COTC) to determine if tumor collection, prospective molecular profiling, and PMed report generation within 1 week was feasible in dogs. Thirty-one dogs with cancers of varying histologies were enrolled. Twenty-four of 31 samples (77%) successfully met all predefined QA/QC criteria and were analyzed via Affymetrix gene expression profiling. A subsequent bioinformatics workflow transformed genomic data into a personalized drug report. Average turnaround from biopsy to report generation was 116 hours (4.8 days). Unsupervised clustering of canine tumor expression data clustered by cancer type, but supervised clustering of tumors based on the personalized drug report clustered by drug class rather than cancer type. Conclusions Collection and turnaround of high quality canine tumor samples, centralized pathology, analyte generation, array hybridization, and bioinformatic analyses matching gene expression to therapeutic options is achievable in a practical clinical window (<1 week). Clustering data show robust signatures by cancer type but also showed patient-to-patient heterogeneity in drug predictions. This lends further support to the inclusion of a heterogeneous population of dogs with cancer into the preclinical modeling of personalized medicine. Future comparative oncology studies optimizing the delivery of PMed strategies may aid cancer drug development. PMID:24637659

Prospective molecular profiling of canine cancers provides a clinically relevant comparative model for evaluating personalized medicine (PMed) trials.

PubMed

Paoloni, Melissa; Webb, Craig; Mazcko, Christina; Cherba, David; Hendricks, William; Lana, Susan; Ehrhart, E J; Charles, Brad; Fehling, Heather; Kumar, Leena; Vail, David; Henson, Michael; Childress, Michael; Kitchell, Barbara; Kingsley, Christopher; Kim, Seungchan; Neff, Mark; Davis, Barbara; Khanna, Chand; Trent, Jeffrey

2014-01-01

Molecularly-guided trials (i.e. PMed) now seek to aid clinical decision-making by matching cancer targets with therapeutic options. Progress has been hampered by the lack of cancer models that account for individual-to-individual heterogeneity within and across cancer types. Naturally occurring cancers in pet animals are heterogeneous and thus provide an opportunity to answer questions about these PMed strategies and optimize translation to human patients. In order to realize this opportunity, it is now necessary to demonstrate the feasibility of conducting molecularly-guided analysis of tumors from dogs with naturally occurring cancer in a clinically relevant setting. A proof-of-concept study was conducted by the Comparative Oncology Trials Consortium (COTC) to determine if tumor collection, prospective molecular profiling, and PMed report generation within 1 week was feasible in dogs. Thirty-one dogs with cancers of varying histologies were enrolled. Twenty-four of 31 samples (77%) successfully met all predefined QA/QC criteria and were analyzed via Affymetrix gene expression profiling. A subsequent bioinformatics workflow transformed genomic data into a personalized drug report. Average turnaround from biopsy to report generation was 116 hours (4.8 days). Unsupervised clustering of canine tumor expression data clustered by cancer type, but supervised clustering of tumors based on the personalized drug report clustered by drug class rather than cancer type. Collection and turnaround of high quality canine tumor samples, centralized pathology, analyte generation, array hybridization, and bioinformatic analyses matching gene expression to therapeutic options is achievable in a practical clinical window (<1 week). Clustering data show robust signatures by cancer type but also showed patient-to-patient heterogeneity in drug predictions. This lends further support to the inclusion of a heterogeneous population of dogs with cancer into the preclinical modeling of personalized medicine. Future comparative oncology studies optimizing the delivery of PMed strategies may aid cancer drug development.

The feasibility of cell phone based electronic diaries for STI/HIV research.

PubMed

Hensel, Devon J; Fortenberry, James D; Harezlak, Jaroslaw; Craig, Dorothy

2012-06-12

Self-reports of sensitive, socially stigmatized or illegal behavior are common in STI/HIV research, but can raise challenges in terms of data reliability and validity. The use of electronic data collection tools, including ecological momentary assessment (EMA), can increase the accuracy of this information by allowing a participant to self-administer a survey or diary entry, in their own environment, as close to the occurrence of the behavior as possible. In this paper, we evaluate the feasibility of using cell phone-based EMA as a tool for understanding sexual risk and STI among adult men and women. As part of a larger prospective clinical study on sexual risk behavior and incident STI in clinically recruited adult men and women, using study-provided cell phones, participants (N = 243) completed thrice-daily EMA diaries monitoring individual and partner-specific emotional attributes, non-sexual activities, non-coital or coital sexual behaviors, and contraceptive behaviors. Using these data, we assess feasibility in terms of participant compliance, behavior reactivity, general method acceptability and method efficacy for capturing behaviors. Participants were highly compliant with diary entry protocol and schedule: over the entire 12 study weeks, participants submitted 89.7% (54,914/61,236) of the expected diary entries, with an average of 18.86 of the 21 expected diaries (85.7%) each week. Submission did not differ substantially across gender, race/ethnicity and baseline sexually transmitted infection status. A sufficient volume and range of sexual behaviors were captured, with reporting trends in different legal and illegal behaviors showing small variation over time. Participants found the methodology to be acceptable, enjoyed and felt comfortable participating in the study. Achieving the correct medium of data collection can drastically improve, or degrade, the timeliness and quality of an individual's self-reported sexual risk behavior, which in turn, is a key factor in the success of intervention or education programs relying on this information. Our findings demonstrate that completion of electronic diaries via cellular phone is feasible way to describe STI/HIV risk among clinically recruited adult men and women.

[Feasibility and diagnostic value of hysterosonography performed in bleeding time in the exploration of abnormal uterine bleeding].

PubMed

Bouzid, A; Ayachi, A; Ben Khedija, M; Menjli, S; Mkaouar, L; Mourali, M

2016-11-01

The aim of our study is to evaluate the feasibility, safety and diagnostic value of hysterosonography performed in an emergency setting among patients consulting for active abnormal uterine bleeding. In this prospective study, we included 216 patients visiting our emergency department for abnormal uterine bleeding. All patients had a transvaginal ultrasound with doppler study and an hysterosonography. Secondly, the patients, in whom we diagnosed a suspected organic lesion, were addressed to an endoscopic or surgical procedure with pathological examination. Initially, we evaluated the feasibility and the safety of hysterosonography and secondly, we compared the two techniques (EEV and hysterosonography), sensitivity, specificity, LHR+and LHR-. The hysterosonography was performed in 98.1 % of patients and its realization has resulted in an additional period of 1.2minutes on average (extreme: 6-12) compared to ultrasound. The tolerance of the hysterosonographic examination was very good in 73.5 % of patients and good in 23.1 % of them. For the 167 patients who had been diagnosed with presumed organic lesions, pathological examination found an endometrial hyperplasia in 34.7 % of cases, polyps in 40.1 % of cases, sub-mucosal fibroids in 11.3 % of cases, endometrial cancer in 0.7 % of cases and other lesions in 13.2 % of cases. The diagnostic value of hysterosonography was superior to ultrasound in the detection of polyps (AUC: 0.894 vs 0.778, P=0.003) and fibromas (AUC: 1.000 vs 0.716, P=0.001) while the two methods showed no significant difference in the detection of hyperplasia. The purpose of our study was to focus on a particular context of use of the hysterosonography consisting on hemorrhagic period and on its realization in the emergency room. We were able to demonstrate that hysterosonography is compatible with the emergency situation as to its feasibility and its diagnostic value and that its realization would contribute to the sorting of patients to guide them immediately to a surgical or endoscopic procedure if necessary. Copyright © 2016 Elsevier Masson SAS. All rights reserved.

A pilot study on the randomization of inferior vena cava filter placement for venous thromboembolism prophylaxis in high-risk trauma patients.

PubMed

Rajasekhar, Anita; Lottenberg, Lawrence; Lottenberg, Richard; Feezor, Robert J; Armen, Scott B; Liu, Huazhi; Efron, Philip A; Crowther, Mark; Ang, Darwin

2011-08-01

Placement of prophylactic inferior vena cava filters (pIVCFs) for the prevention of pulmonary embolism (PE) in high-risk trauma patients (HRTPs) are widely practiced despite the lack of Level I data supporting this use. We report the 2-year interim analysis of the Filters in Trauma pilot study. This is a single institution, prospective randomized controlled pilot feasibility study in a Level I trauma center. HRTPs were identified for pIVCF placement by the Eastern Association for the Surgery of Trauma guidelines. From November 2008 to November 2010, HRTPs were enrolled and randomized to either pIVCF or no pIVCF. All patients received pharmacologic prophylaxis when safe. Primary outcomes included feasibility objectives and secondary outcomes were incidence of PE, deep vein thrombosis (DVT), and death. Thirty-four of 38 enrolled patients were eligible for analysis. The baseline sociodemographic characteristics were balanced between the both groups. Results of the feasibility objectives included: time from admission to enrollment (mean, 47.4 hours ± 22.0 hours), time from enrollment to randomization (mean, 4.8 hours ± 9.1 hours), time from randomization to IVCF placement (mean, 16.9 hours ± 9.2 hours), adherence to weekly compression ultrasound within first month (IVCF group = 44.4%; non-IVCF group = 62.5%), and 1-month clinical follow-up (IVCF group = 83.3%; non-IVCF group = 100%). At 6-month follow-up, one PE in the nonfilter group and one DVT in the filter group had occurred. One non-PE-related death occurred in the filter group. Barriers to enrollment included inability to obtain informed consent due to patient refusal or no next of kin identified and delayed notification of eligibility status. Our pilot study demonstrates for the first time that a randomized controlled trial evaluating the efficacy of pIVCFs in trauma patients is feasible. This pilot data will be used to inform the design of a multicenter randomized controlled trial to determine the incidence of PE and DVT in HRTPs receiving pIVCFs versus no pIVCF.

Pure transumbilical SILS gastric bypass with mechanical circular gastrojejunal anastomosis feasibility.

PubMed

Pitot, Denis; Takieddine, Mazen; Abbassi, Ziad; Agrafiotis, Apostolos; Bruyns, Laurence; Ceuterick, Michel; Daoudi, Nabil; Dolimont, Amaury; Soulimani, Abdelak; Vaneukem, Pol

2014-10-01

Since Wittgrove introduced the laparoscopic version of the gastric bypass in 1994, the interest still remains in the decrease of the abdominal wall trauma in order to optimize the benefits of laparoscopy on postoperative pain, cosmesis, hospital stay, and convalescence in bariatric patients. This work is to report the feasibility of gastric bypass surgery by a pure transumbilical single-incision laparoscopic surgery (SILS) with a mechanical circular gastrojejunal anastomosis. Thirty-four patients (10 males and 24 females) were offered to receive gastric bypass with circular mechanical gastrojejunal anastomosis by Single Incision Laparoscopic Surgery (SILS) using pure transumbilical access. Anastomotic leak occurrence was the primary end-point. Patients demographics, operative time, additional trocarts, hemorrhage, intra abdominal abscess, length of post-operative stay, readmission, 30 days death, gastrojejunal anastomosis stricture, marginal ulcers, reflux complains, seromas, incisional hernias, and % excess BMI loss were also recorded in a prospective database. Primary end-point showed no anastomotic leak occurrence during the hospital stay or during the first 30 post-operative days. SILS gastric bypass with a circular mechanical gastrojejunal anastomosis is feasible and seems to be safe.

Volumetric Assessment of Swallowing Muscles: A Comparison of CT and MRI Segmentation.

PubMed

Sporns, Kim Barbara; Hanning, Uta; Schmidt, Rene; Muhle, Paul; Wirth, Rainer; Zimmer, Sebastian; Dziewas, Rainer; Suntrup-Krueger, Sonja; Sporns, Peter Bernhard; Heindel, Walter; Schwindt, Wolfram

2018-05-01

 Recent retrospective studies have proposed a high correlation between atrophy of swallowing muscles, age, severity of dysphagia and aspiration status based on computed tomography (CT). However, ionizing radiation poses an ethical barrier to research in prospective non-patient populations. Hence, there is a need to prove the efficacy of techniques that rely on noninvasive methods and produce high-resolution soft tissue images such as magnetic resonance imaging (MRI). The objective of this study was therefore to compare the segmentation results of swallowing muscles using CT and MRI.  Retrospective study of 21 patients (median age: 46.6; gender: 11 female) who underwent CT and MRI of the head and neck region within a time frame of less than 50 days because of suspected head and neck cancer using contrast agent. CT and MR images were segmented by two blinded readers using Medical Imaging Toolkit (MITK) and both modalities were tested (with the equivalence test) regarding the segmented muscle volumes. Adjustment for multiple testing was performed using the Bonferroni test and the potential time effect of the muscle volumes and the time interval between the modalities was assessed by a spearman correlation. The study was approved by the local ethics committee.  The median volumes for each muscle belly of the digastric muscle derived from CT were 3051 mm 3 (left) and 2969 mm 3 (right), and from MRI they were 3218 mm 3 (left) and 3027 mm 3 (right). The median volume of the geniohyoid muscle was 6580 mm 3 on CT and 6648 mm 3 on MRI. The interrater reliability was high for all segmented muscles. The mean time interval between the CT and MRI examinations was 34 days (IQR 25; 41). The muscle differences of each muscle between the two modalities did not reveal significant correlation to the time interval between the examinations (digastric left r = 0.003 and digastric right r = -0.008; geniohyoid muscle r = 0.075).  CT-based segmentation and MRI-based segmentation of the digastric and geniohyoid muscle are equally feasible. The potential advantage of MRI for prospective studies is the absence of ionizing radiation.   · CT-based segmentation and MRI-based segmentation of the swallowing muscles are equally feasible.. · The advantage of MRI is the absence of ionizing radiation.. · MRI should therefore be deployed for future prospective studies.. · Sporns KB, Hanning U, Schmidt R et al. Volumetric Assessment of Swallowing Muscles: A Comparison of CT and MRI Segmentation. Fortschr Röntgenstr 2018; 190: 441 - 446. © Georg Thieme Verlag KG Stuttgart · New York.

[Translation and linguistic validation in classical Arabic of the urinary symptom profile (USP) questionnaire].

PubMed

Arabi, H; Bendeddouche, I; Khalfaoui, S; Louardi, N; Ameur, A; Lebreton, F; Amarenco, G

2013-04-01

The objective was to translate and linguistically validate in classical Arabic; the French version of the Urinary Symptom Profile (USP), the scale adapted to vesico-sphincter disorders. Prospective study of 30 patients suffering the vesico-sphincter disorders. The translation was obtained by the method: translation back-translation. Patients completed the final questionnaire on day 0 and day 15. The feasibility, acceptability, internal consistency using Cronbach's alpha and test-retest repeatability by the interclass correlation coefficient (ICC) with the confidence interval (CI) were studied. The sample consisted of 30 subjects including 20 men (66.6%) and 10 women (33.3%). The mean age was 48±18, 14 years ranging from 25 to 70 years. The questionnaire was feasible and acceptable. The Cronbach's alpha of the three dimensions, urinary stress incontinence, overactive bladder and voiding difficulties was respectively 0.9880, 0.9774 and 0.9683, respectively; the ICC was 0.9762 (95% CI: 0.9307-0.9919), 0.9558 (CI 95%: 0.8738-0.9849) and 0.9385 (95% CI: 0.8274-0.9789). The Arabic version of the classic USP had excellent internal consistency and excellent repeatability enable a full assessment of all urinary disorders and their severity. Copyright © 2013 Elsevier Masson SAS. All rights reserved.

Coronary Artery Anomalies and Variants: Technical Feasibility of Assessment with Coronary MR Angiography at 3 T1

PubMed Central

Gharib, Ahmed M.; Ho, Vincent B.; Rosing, Douglas R.; Herzka, Daniel A.; Stuber, Matthias; Arai, Andrew E.; Pettigrew, Roderic I.

2008-01-01

The purpose of this study was to prospectively use a whole-heart three-dimensional (3D) coronary magnetic resonance (MR) angiography technique specifically adapted for use at 3 T and a parallel imaging technique (sensitivity encoding) to evaluate coronary arterial anomalies and variants (CAAV). This HIPAA-compliant study was approved by the local institutional review board, and informed consent was obtained from all participants. Twenty-two participants (11 men, 11 women; age range, 18–62 years) were included. Ten participants were healthy volunteers, whereas 12 participants were patients suspected of having CAAV. Coronary MR angiography was performed with a 3-T MR imager. A 3D free-breathing navigator-gated and vector electrocardiographically–gated segmented k-space gradient-echo sequence with adiabatic T2 preparation pulse and parallel imaging (sensitivity encoding) was used. Whole-heart acquisitions (repetition time msec/echo time msec, 4/1.35; 20° flip angle; 1 × 1 × 2-mm acquired voxel size) lasted 10–12 minutes. Mean examination time was 41 minutes ± 14 (standard deviation). Findings included aneurysms, ectasia, arteriovenous fistulas, and anomalous origins. The 3D whole-heart acquisitions developed for use with 3 T are feasible for use in the assessment of CAAV. © RSNA, 2008 PMID:18372470

Multicenter study of quantitative computed tomography analysis using a computer-aided three-dimensional system in patients with idiopathic pulmonary fibrosis.

PubMed

Iwasawa, Tae; Kanauchi, Tetsu; Hoshi, Toshiko; Ogura, Takashi; Baba, Tomohisa; Gotoh, Toshiyuki; Oba, Mari S

2016-01-01

To evaluate the feasibility of automated quantitative analysis with a three-dimensional (3D) computer-aided system (i.e., Gaussian histogram normalized correlation, GHNC) of computed tomography (CT) images from different scanners. Each institution's review board approved the research protocol. Informed patient consent was not required. The participants in this multicenter prospective study were 80 patients (65 men, 15 women) with idiopathic pulmonary fibrosis. Their mean age was 70.6 years. Computed tomography (CT) images were obtained by four different scanners set at different exposures. We measured the extent of fibrosis using GHNC, and used Pearson's correlation analysis, Bland-Altman plots, and kappa analysis to directly compare the GHNC results with manual scoring by radiologists. Multiple linear regression analysis was performed to determine the association between the CT data and forced vital capacity (FVC). For each scanner, the extent of fibrosis as determined by GHNC was significantly correlated with the radiologists' score. In multivariate analysis, the extent of fibrosis as determined by GHNC was significantly correlated with FVC (p < 0.001). There was no significant difference between the results obtained using different CT scanners. Gaussian histogram normalized correlation was feasible, irrespective of the type of CT scanner used.

Probiotics: Prevention of Severe Pneumonia and Endotracheal Colonization Trial-PROSPECT: protocol for a feasibility randomized pilot trial.

PubMed

Johnstone, Jennie; Meade, Maureen; Marshall, John; Heyland, Daren K; Surette, Michael G; Bowdish, Dawn Me; Lauzier, Francois; Thebane, Lehana; Cook, Deborah J

2015-01-01

Probiotics are defined as live microorganisms that may confer health benefits when ingested. Meta-analysis of probiotic trials suggests a 25 % lower ventilator-associated pneumonia (VAP) and 18 % lower infection rates overall when administered to patients in the intensive care unit (ICU). However, prior trials are small, largely single center, and at high risk of bias. Before a large rigorous trial is launched, testing whether probiotics confer benefit, harm, or have no impact, a pilot trial is needed. The aim of the PROSPECT Pilot Trial is to determine the feasibility of performing a larger trial in mechanically ventilated critically ill patients investigating Lactobacillus rhamnosus GG. A priori, we determined that the feasibility of the larger trial would be based on timely recruitment, high protocol adherence, minimal contamination, and an acceptable VAP rate. Patients ≥18 years old in the ICU who are anticipated to receive mechanical ventilation for ≥72 hours will be included. Patients are excluded if they are at increased risk of probiotic-associated infection, have strict enteral medication contraindications, are pregnant, previously enrolled in a related trial, or are receiving palliative care. Following informed consent, patients are randomized in variable unspecified block sizes in a fixed 1:1 ratio, stratified by ICU, and medical, surgical, or trauma admitting diagnosis. Patients receive 1 × 10 10 colony forming units of L. rhamnosus GG (Culturelle, Locin Industries Ltd) or an identical placebo suspended in tap water administered twice daily via nasogastric tube in the ICU. Clinical and research staff, patients, and families are blinded. The primary outcomes for this pilot trial are the following: (1) recruitment success, (2) ≥90 % protocol adherence, (3) ≤5 % contamination, and (4) ~10 % VAP rate. Additional clinical outcomes are VAP, other infections, diarrhea (total, antibiotic associated, and Clostridium difficile), ICU and hospital length of stay, and mortality. The morbidity, mortality, and cost of VAP underscore the need for cost-effective prophylactic interventions. The PROSPECT Pilot Trial is the initial step toward rigorously evaluating whether probiotics decrease nosocomial infections, have no effect, or actually cause infections in critically ill patients. ClinicalTrials.gov. NCT01782755.

Clinical Outcomes With Dose-Escalated Adaptive Radiation Therapy for Urinary Bladder Cancer: A Prospective Study

DOE Office of Scientific and Technical Information (OSTI.GOV)

Murthy, Vedang, E-mail: vmurthy@actrec.gov.in; Masodkar, Renuka; Kalyani, Nikhil

Purpose: The purpose of this study was to assess feasibility, clinical outcomes, and toxicity in patients with bladder cancer treated with adaptive, image guided radiation therapy (IGRT) for bladder preservation as a part of trimodality treatment. The role of dose escalation was also studied. Methods and Materials: Forty-four patients with localized bladder cancer were enrolled in a prospective study. They underwent maximal safe resection of bladder tumor and concurrent platinum-based chemotherapy. Patients with large tumors were offered induction chemotherapy. Radiation therapy planning was done using either 3 (n=34) or 6 (n=10) concentrically grown planning target volumes (PTV). Patients received 64 Gymore » in 32 fractions to the whole bladder and 55 Gy to the pelvic nodes and, if appropriate, a simultaneous integrated boost to the tumor bed to 68 Gy (equivalent dose for 2-Gy fractions assuming α/β of 10 [EQD2]{sub 10} = 68.7 Gy). Daily megavoltage (MV) imaging helped to choose the most appropriate PTV encompassing bladder for the particular day (using plan-of-the-day approach). Results: Most patients (88%) had T2 disease. Sixteen patients (36%) received neoadjuvant chemotherapy. A majority of the patients (73%) received prophylactic nodal irradiation, whereas 55% of the patients received escalated dose to the tumor bed. With a median follow-up of 30 months, the 3-year locoregional control (LRC), disease-free survival, and overall survival (OS) were 78%, 66%, and 67%, respectively. The bladder preservation rate was 83%. LRC (87% vs 68%, respectively, P=.748) and OS (74% vs 60%, respectively, P=.36) rates were better in patients receiving dose escalation. Instances of acute and late Radiation Therapy Oncology Group (RTOG) grade 3 genitourinary toxicity was seen in 5 (11%) and 2 (4%) patients, respectively. There was no acute or late RTOG grade 3 or higher gastrointestinal toxicity. Conclusions: Adaptive IGRT using plan-of-the-day approach for bladder preservation is clinically feasible, with good oncological outcomes and low rates of acute and late toxicities. Dose escalation is safe and possibly improves outcomes in bladder preservation.« less

Pediatric American College of Surgeons National Surgical Quality Improvement Program: feasibility of a novel, prospective assessment of surgical outcomes.

PubMed

Raval, Mehul V; Dillon, Peter W; Bruny, Jennifer L; Ko, Clifford Y; Hall, Bruce L; Moss, R Lawrence; Oldham, Keith T; Richards, Karen E; Vinocur, Charles D; Ziegler, Moritz M

2011-01-01

The American College of Surgeons (ACS) National Surgical Quality Improvement Program (NSQIP) provides validated assessment of surgical outcomes. This study reports initiation of an ACS NSQIP Pediatric at 4 children's hospitals. From October 2008 to June 2009, 121 data variables were prospectively collected for 3315 patients, including 30-day outcomes and tailoring the ACS NSQIP methodology to children's surgical specialties. Three hundred seven postoperative complications/occurrences were detected in 231 patients representing 7.0% of the study population. Of the patients with complications, 175 (75.7%) had 1, 39 (16.9%) had 2, and 17 (7.4%) had 3 or more complications. There were 13 deaths (0.39%) and 14 intraoperative occurrences (0.42%) detected. The most common complications were infection, 105 (34%) (SSI, 54; sepsis, 31; pneumonia, 13; urinary tract infection, 7); airway/respiratory events, 27 (9%); wound disruption, 18 (6%); neurologic events, 8 (3%) (nerve injury, 4; stroke/vascular event, 2; hemorrhage, 2); deep vein thrombosis, 3 (<1%); renal failure, 3 (<1%); and cardiac events, 3 (<1%). Current sampling captures 17.5% of cases across institutions with unadjusted complication rates ranging from 6.8% to 10.2%. Completeness of data collection for all variables exceeded 95% with 98% interrater reliability and 87% of patients having full 30-day follow-up. These data represent the first multiinstitutional prospective assessment of specialty-specific surgical outcomes in children. The ACS NSQIP Pediatric is poised for institutional expansion and future development of risk-adjusted models. Copyright © 2011 Elsevier Inc. All rights reserved.

Impact of scribes on patient interaction, productivity, and revenue in a cardiology clinic: a prospective study

PubMed Central

Bank, Alan J; Obetz, Christopher; Konrardy, Ann; Khan, Akbar; Pillai, Kamalesh M; McKinley, Benjamin J; Gage, Ryan M; Turnbull, Mark A; Kenney, William O

2013-01-01

Objective Scribes have been used in the emergency department to improve physician productivity and patient interaction. There are no controlled, prospective studies of scribe use in the clinic setting. Methods A prospective controlled study compared standard visits (20 minute follow-up and 40 minute new patient) to a scribe system (15 minute follow-up and 30 minute new patient) in a cardiology clinic. Physician productivity, patient satisfaction, physician–patient interaction, and revenue were measured. Results Four physicians saw 129 patients using standard care and 210 patients with scribes during 65 clinic hours each. Patients seen per hour increased (P < 0.001) from 2.2 ± 0.3 to 3.5 ± 0.4 (59% increase) and work relative value units (wRVU) per hour increased (P < 0.001) from 3.5 ± 1.3 to 5.5 ± 1.3 (57% increase). Patient satisfaction was high at baseline and unchanged with scribes. In a substudy, direct patient contact time was lower (9.1 ± 2.0 versus 12.9 ± 3.4 minutes; P < 0.01) for scribe visits, but time of patient interaction (without computer) was greater (6.7 ± 2.1 versus 1.5 ± 1.9 minutes; P < 0.01). Subjective assessment of physician–patient interaction (1–10) was higher (P < 0.01) on scribe visits (9.1 ± 0.9 versus 7.9 ± 1.1). Direct and indirect (downstream) revenue per patient seen was $142 and $2,398, with $205,740 additional revenue generated from the 81 additional patients seen with scribes. Conclusion Using scribes in a cardiology clinic is feasible, produces improvements in physician–patient interaction, and results in large increases in physician productivity and system cardiovascular revenue. PMID:23966799

A prospective, single-arm study on the use of the da Vinci® Table Motion with the Trumpf TS7000dV operating table.

PubMed

Morelli, Luca; Palmeri, Matteo; Simoncini, Tommaso; Cela, Vito; Perutelli, Alessandra; Selli, Cesare; Buccianti, Piero; Francesca, Francesco; Cecchi, Massimo; Zirafa, Cristina; Bastiani, Luca; Cuschieri, Alfred; Melfi, Franca

2018-03-30

The da Vinci® Table Motion (dVTM) comprises a combination of a unique operating table (Trumpf Medical™ TruSystem® 7000dV) capable of isocenter motion connected wirelessly with the da Vinci Xi® robotic platform, thereby enabling patients to be repositioned without removal of instruments and or undocking the robot. Between May 2015 to October 2015, the first human use of dVTM was carried out in this prospective, single-arm, post-market study in the EU, for which 40 patients from general surgery (GS), urology (U), or gynecology (G) were enrolled prospectively. Primary endpoints of the study were dVTM feasibility, efficacy, and safety. Surgeons from the three specialties obtained targeting success and the required table positioning in all cases. Table movement/repositioning was necessary to gain exposure of the operating field in 106/116 table moves (91.3%), change target in 2/116 table moves (1.7%), achieve hemodynamic relief in 4/116 table moves (3.5%), and improve external access for tumor removal in 4/116 table moves (3.5%). There was a significantly higher use of tilt and tilt plus Trendelenburg in GS group (GS vs. U p = 0.055 and GS vs. G p = 0.054). There were no dVTM safety-related or adverse events. The dVTM with TruSystem 7000dV operating table in wireless communication with the da Vinci Xi is a perfectly safe and effective synergistic combination, which allows repositioning of the patient whenever needed without imposing any delay in the execution of the operation. Moreover, it is helpful in avoiding extreme positions and enables the anesthesiologist to provide immediate and effective hemodynamic relief to the patient when needed.

Feasibility of a Mobile Phone-Based Surveillance for Surgical Site Infections in Rural India.

PubMed

Pathak, Ashish; Sharma, Shailendra; Sharma, Megha; Mahadik, Vijay K; Lundborg, Cecilia Stålsby

2015-11-01

To assess the feasibility of using mobile communication technology in completing a 30-day follow-up of surgical site infection (SSI). SSIs are infections occurring up to 30 days after an operative procedure. This prospective exploratory study was conducted in a cohort of patients who were admitted and operated on in the general surgery wards of a rural hospital in India from October 2010 to June 2011. At the time of discharge, all patients were requested to follow-up in the surgical outpatient clinic at 30 days after surgery. If this was not done, a mobile phone-based surveillance was done to complete the follow-up. The mean age of the 536 operated-on patients was 40 years (95% confidence interval [CI], 38-41 years). The mean duration of hospital stay was 10.7 days (95% CI, 9.9-11.6 days). Most (81%) operated-on patients were from rural areas, and 397 (75%) were male. Among the operated-on patients the ownership of mobile phones was 75% (95% CI, 73-78%). The remaining 25% of patients (n=133) used a shared mobile phone. For 380 patients (74.5%) the follow-up was completed by mobile phones. The SSI rate at follow-up was 6.3% (n=34). In 10 patients, an SSI was detected over the mobile phone. Mobile communication technology is feasible to be used in rural settings to complete case follow-up for SSIs.

Accuracy of fetal sex determination on ultrasound examination in the first trimester of pregnancy.

PubMed

Manzanares, Sebastián; Benítez, Adara; Naveiro-Fuentes, Mariña; López-Criado, María Setefilla; Sánchez-Gila, Mar

2016-06-01

The aim of this study was to evaluate the feasibility and success rate of sex determination on transabdominal sonographic examination at 11-13 weeks' gestation and to identify factors influencing accuracy. In this prospective observational evaluation of 672 fetuses between 11 weeks' and 13 weeks + 6 days' gestational age (GA), we determined fetal sex according to the angle of the genital tubercle viewed on the midsagittal plane. We also analyzed maternal, fetal, and operator factors possibly influencing the accuracy of the determination. Fetal sex determination was feasible in 608 of the 672 fetuses (90.5%), and the prediction was correct in 532 of those 608 cases (87.5%). Fetal sex was more accurately predicted as the fetal crown-rump length (CRL), and GA increased and was less accurately predicted as the maternal body mass index increased. A CRL greater than 55.7 mm, a GA more than 12 weeks + 2 days, and a body mass index below 23.8 were identified as the best cutoff values for sex prediction. None of the other analyzed factors influenced the feasibility or accuracy of sex determination. The sex of a fetus can be accurately determined on sonographic examination in the first trimester of pregnancy; the accuracy of this prediction is influenced by the fetal CRL and GA and by the maternal body mass index. © 2015 Wiley Periodicals, Inc. J Clin Ultrasound 44:272-277, 2016. © 2015 Wiley Periodicals, Inc.

Feasibility of implementing a comprehensive warfarin pharmacogenetics service.

PubMed

Nutescu, Edith A; Drozda, Katarzyna; Bress, Adam P; Galanter, William L; Stevenson, James; Stamos, Thomas D; Desai, Ankit A; Duarte, Julio D; Gordeuk, Victor; Peace, David; Kadkol, Shrihari S; Dodge, Carol; Saraf, Santosh; Garofalo, John; Krishnan, Jerry A; Garcia, Joe G N; Cavallari, Larisa H

2013-11-01

To determine the procedural feasibility of a pharmacist-led interdisciplinary service for providing genotype-guided warfarin dosing for hospitalized patients newly starting warfarin. Prospective observational study. A 438-bed tertiary care hospital affiliated with a large academic institution. Eighty patients who started warfarin therapy and were managed by a newly implemented pharmacogenetics service. All patients received routine warfarin genotyping and clinical pharmacogenetics consultation. The primary outcomes were percentage of genotype-guided dose recommendations available prior to the second warfarin dose and adherence of the medical staff to doses recommended by the pharmacogenetics service. Of 436 genotype orders placed during the first 6 months of the service, 190 (44%) were deemed appropriate. For the 80 patients on the service who consented to data collection, 76% of the genotypes were available prior to the second warfarin dose. The median (range) time from genotype order to genotype result was 26 hours (7-80 hrs), and the time to genotype-guided dose recommendation was 30 hours (7-80 hrs). A total of 73% of warfarin doses ordered by the medical staff were within 0.5 mg of the daily dose recommended by the pharmacogenetics consult service. Providing routine genotype-guided warfarin dosing supported by a pharmacogenetics consult service is feasible from a procedural standpoint, with most genotypes available prior to the second warfarin dose and good adherence to genotype-guided dose recommendations by the medical staff. © 2013 Pharmacotherapy Publications, Inc.

Successful Fiber Sensing Technologies and Hot Topics for the Near Future

NASA Astrophysics Data System (ADS)

López-Higuera, J. M.; Cobo, A.; Conde, Olga; Lomer, M.; Madruga, F.; Quintela, M. A.; Quintela, A.; Mirapeix, J.

2008-10-01

Inside the Photonics field Optical Fiber Sensors (OFS) are currently being used and will still be used in the future in a wide number of applications because its properties present technical advantages over traditional techniques or, sometimes, is practically the only feasible solution. In this paper, the more successful techniques will be reviewed. Then a prospective for the near future of the market and hot topics in which invest research resources will be suggested.

From integrated observation of pre-earthquake signals towards physical-based forecasting: A prospective test experiment

NASA Astrophysics Data System (ADS)

Ouzounov, D.; Pulinets, S. A.; Tramutoli, V.; Lee, L.; Liu, J. G.; Hattori, K.; Kafatos, M.

2013-12-01

We are conducting an integrated study involving multi-parameter observations over different seismo- tectonics regions in our investigation of phenomena preceding major earthquakes. Our approach is based on a systematic analysis of several selected parameters namely: gas discharge; thermal infrared radiation; ionospheric electron concentration; and atmospheric temperature and humidity, which we suppose are associated with earthquake preparation phase. We intended to test in prospective mode the set of geophysical measurements for different regions of active earthquakes and volcanoes. In 2012-13 we established a collaborative framework with the leading projects PRE-EARTHQUAKE (EU) and iSTEP3 (Taiwan) for coordinate measurements and prospective validation over seven test regions: Southern California (USA), Eastern Honshu (Japan), Italy, Turkey, Greece, Taiwan (ROC), Kamchatka and Sakhalin (Russia). The current experiment provided a 'stress test' opportunity to validate the physical based approach in teal -time over regions of high seismicity. Our initial results are: (1) Prospective tests have shown the presence in real time of anomalies in the atmosphere before most of the significant (M>5.5) earthquakes in all regions; (2) False positive rate alarm is different for each region and varying between 50% (Italy, Kamchatka and California) to 25% (Taiwan and Japan) with a significant reduction of false positives when at least two parameters are contemporary used; (3) One of most complex problem, which is still open, was the systematic collection and real-time integration of pre-earthquake observations. Our findings suggest that the physical based short-term forecast is feasible and more tests are needed. We discus the physical concept we used, the future integration of data observations and related developments.

A study on the oil-based drilling cutting pyrolysis residue resource utilization by the exploration and development of shale gas.

PubMed

Wang, Chao-Qiang; Jin, Ji-Zhong; Lin, Xiao-Yan; Xiong, De-Ming; Mei, Xu-Dong

2017-07-01

Based on the requirement of national energy conservation and environmental protection, attention has been given to building an environment-friendly and resource-saving society. Shale gas oil-based drilling cutting pyrolysis residues (ODPRs) have been used as the main research object to developing new technology which can convert the residues into a harmless and recyclable material. Using the test data of ODPR, we analyze the development prospect in the building material industry and provide a scheme to utilize this particular solid-waste efficiently. Theoretically speaking, the ODPR resource utilization such as admixture of cement, making sintered brick, and non-fired brick, by the exploration and development of Fuling shale gas is feasible.

Empowering Promotores de Salud as partners in cancer education and research in rural southwest Kansas.

PubMed

Cupertino, Ana Paula; Saint-Elin, Mercedes; de Los Rios, Johana Bravo; Engelman, Kimberly K; Greiner, K Allen; Ellerbeck, Edward F; Nápoles, Anna M

2015-01-01

To describe community-based participatory processes used to develop promotore training on cancer research, and to assess the feasibility of training promotores from rural communities to disseminate cancer research information. Prospective, cohort design. Rural communities in the state of Kansas. 34 Spanish-speaking promotores attended an information session; 27 enrolled and 22 completed training. With input from a community advisory board, the authors developed a leadership and cancer curriculum and trained Spanish-speaking promotores to disseminate information on cancer research. Promotores completed pretraining and post-training surveys in Spanish to assess demographic characteristics and changes in knowledge of cancer, cancer treatment and cancer research studies, and intent to participate in cancer research. Cancer knowledge, awareness of cancer clinical trials, interest in participating in cancer clinical research studies. Compared to pretraining, after training, promotores were more likely to correctly define cancer, identify biopsies, describe cancer stages, and report ever having heard of cancer research studies. Completion rates of the training and willingness to participate in cancer research were high, supporting the feasibility of training promotores to deliver community-based education to promote cancer research participation. Nursing professionals and researchers can collaborate with promotores to disseminate cancer education and research among underserved rural Latino communities in Kansas and elsewhere. Members of these communities appear willing and interested in improving their knowledge of cancer and cancer clinical trials.

Initiating transitional care for adolescents with cystic fibrosis at the age of 12 is both feasible and promising.

PubMed

Skov, M; Teilmann, G; Damgaard, I N; Nielsen, K G; Hertz, P G; Holgersen, M G; Presfeldt, M; Dalager, A M S; Brask, M; Boisen, K A

2018-05-05

Adolescence is a vulnerable period in cystic fibrosis, associated with declining lung function. This study described, implemented and evaluated a transition programme for adolescents. We conducted a single centre, non-randomised and non-controlled prospective programme at the cystic fibrosis centre at Copenhagen University Hospital Rigshospitalet from 2010-2011, assessing patients aged 12 to 18 at baseline and after 12 months. Changes implemented included staff training on communication, a more youth friendly feel to the outpatient clinic, the introduction of youth consultations partly alone with the adolescent, and a parents' evening focusing on cystic fibrosis in adolescence. Lung function and body mass index (BMI) were measured monthly and adolescents were assessed for their readiness for transition and quality of life at baseline and 12 months. We found that 40 (98%) of the eligible patients participated and youth consultations were successfully implemented with no dropouts. The readiness checklist score increased significantly over the one-year study period, indicating increased readiness for transfer and self-care. Overall quality of life, lung function and BMI remained stable during the study period. A well structured transition programme for cystic fibrosis patients as young as 12 years of age proved to be both feasible and sustainable. This article is protected by copyright. All rights reserved. This article is protected by copyright. All rights reserved.

A Feasibility Study Comparing Platelet-Rich Plasma Injection With Saline for the Treatment of Plantar Fasciitis Using a Prospective, Randomized Trial Design.

PubMed

Johnson-Lynn, Sarah; Cooney, Alan; Ferguson, Diarmaid; Bunn, Deborah; Gray, William; Coorsh, Jonathan; Kakwani, Rajesh; Townshend, David

2018-05-01

Platelet-rich plasma (PRP) has been advocated for treatment of plantar fasciitis but there are few good-quality clinical trials to support its use. We conducted a feasibility study of PRP versus saline for treatment of plantar fasciitis. Patients with 6 months or more of magnetic resonance imaging-proven plantar fasciitis, who had failed conservative treatment were invited to participate in the study. Patients were block randomized to either PRP or an equivalent volume of saline. The techniques used for injection and rehabilitation were standardized for both groups. The patient and assessor were blinded. Visual analogue scale (VAS) for pain and painDETECT score were recorded preoperatively and at 6 months follow-up. From 35 patients approached, 28 (19 female, mean age 50 years) were recruited, with 14 randomized to each arm. At 6 months, 8 patients (28.6%) were lost to follow-up. There was a significant change in VAS score from baseline to follow-up in both intervention (mean change 37.2, P = .008) and control (mean change 42.2, P = .003) groups. There was no correlation between preoperative painDETECT score and change in VAS. Recruitment and loss to follow-up rates were relatively high. Both treatments resulted in a similar, significant, improvement in symptoms. Level II.

Pilot Evaluation of a Palliative and End-of-Life Communication Intervention for Parents of Children With a Brain Tumor.

PubMed

Hendricks-Ferguson, Verna L; Pradhan, Kamnesh; Shih, Chie-Schin; Gauvain, Karen M; Kane, Javier R; Liu, Jingxia; Haase, Joan E

Providing timely palliative and end-of-life care (PC/EOL) information to parents of children with a serious illness is a national health care priority. The goals of this study were to determine feasibility, acceptability, and parent responses related to a PC/EOL communication intervention, titled "Communication Plan: Early through End of Life (COMPLETE)" to parents of children with a brain tumor. The study was a 2-site prospective, single-group pilot study targeting parents' stress and coping outcomes. The sample included 13 parents of 11 children (ie, 11 families). During the first 6 months postdiagnosis, we evaluated parent outcomes at 4 time points (baseline and 3 post-sessions). Our findings included significant decline in decision regret ( P = .0089); strong, significantly increased hope ( P ≤ .0001); and significantly decreased uncertainty ( P = .04). Over time, more than half of the parents (61.5%) preferred to receive information about their child's current condition and PC/EOL options. Our findings provide evidence to suggest that the COMPLETE intervention is feasible and acceptable and produces promising effects on 3 parent outcomes (ie, decision regret, hope, and uncertainty) in parents of children with a brain tumor. Further research is indicated to evaluate COMPLETE with a larger sample of parents of children with cancer and with a control group.

Reduce chest pain using modified silicone fluted drain tube for chest drainage after video-assisted thoracic surgery (VATS) lung resection.

PubMed

Li, Xin; Hu, Bin; Miao, Jinbai; Li, Hui

2016-02-01

The aim of this study was to assess the feasibility, efficacy and safety of a modified silicone fluted drain tube after video-assisted thoracic surgery (VATS) lung resection. The prospective randomized study included 50 patients who underwent VATS lung resection between March 2015 and June 2015. Eligible patients were randomized into two groups: experimental group (using the silicone fluted drain tubes for chest drainage) and control group (using standard drain tubes for chest drainage). The volume and characteristics of drainage, postoperative (PO) pain scores and hospital stay were recorded. All patients received standard care during hospital admission. In accordance with the exit criteria, three patients were excluded from study. The remaining 47 patients included in the final analysis were divided into two groups: experiment group (N=24) and control group (N=23). There was no significant difference between the two groups in terms of age, sex, height, weight, clinical diagnosis and type of surgical procedure. There was a trend toward less PO pain in experimental group on postoperative day (POD) 1, with a statistically significant difference. Patients in experimental group had a reduced occurrence of fever [temperature (T) >37.4 °C] compared to the control group. The silicone fluted drain tube is feasible and safe and may relieve patient PO pain and reduce occurrence of fever without the added risk of PO complications.

Human Papillomavirus Genotyping After Denaturation of Specimens for Hybrid Capture 2 Testing: Feasibility Study for the HPV Persistence and Progression Cohort†

PubMed Central

LaMere, Brandon J.; Kornegay, Janet; Fetterman, Barbara; Sadorra, Mark; Shieh, Jen; Castle, Philip E.

2009-01-01

Human papillomavirus (HPV) genotyping could be clinically useful, depending on the results of large, prospective studies like the HPV Persistence and Progression cohort. The cohort is based on genotyping and follow-up of Hybrid Capture-positive women at Kaiser Permanente, Northern California. HPV DNA testing by Hybrid Capture 2 requires denaturation with alkali, possibly damaging the DNA for optimal PCR-based genotyping. A feasibility study was conducted on paired aliquots of anonymized specimens from 100 women with low-grade intraepithelial lesion cytology. Test aliquots were left in denaturant for 10 or 18 hours at 4°C and then neutralized; comparison aliquots were not denatured but diluted to match the timing, temperature, concentration and salt conditions of the treated specimens. The masked aliquots were tested using a commercialized PCR-based assay that detects of 37 HPV genotypes. There was no overall effect of treatment on test positivity or number of types. HPV16 was marginally more likely to be detected in untreated versus treated aliquots (P = 0.09) but HPV45 was marginally more likely to be detected in treated than untreated aliquots (P = 0.07), suggesting that these differences represented chance (intra-test variability). It can be concluded that residual Hybrid Capture-positive specimens can be accurately genotyped by PCR after Hybrid Capture 2 processing. PMID:17673302

HOME-BASED SELF-DELIVERED MIRROR THERAPY FOR PHANTOM PAIN: A PILOT STUDY*

PubMed Central

Darnall, Beth D.; Li, Hong

2014-01-01

Objective To test the feasibility and preliminary efficacy of self-delivered home-based mirror therapy for phantom pain. Design Uncontrolled prospective treatment outcome pilot study. Participants Forty community-dwelling adults with unilateral amputation and phantom pain >3 on a 0–10 numeric rating scale enrolled either during a one-time study visit (n = 30) or remotely (n = 10). Methods Participants received an explanation of mirror therapy and were asked to self-treat for 25 min daily. Participants completed and posted back sets of outcomes questionnaires at months 1 and 2 post-treatment. Main outcome was mean phantom pain intensity at post-treatment. Results A significant reduction in mean phantom pain intensity was found at month 1 (n = 31, p = 0.0002) and at month 2 (n = 26, p = 0.002). The overall median percentage reduction at month 2 was 15.4%. Subjects with high education (>16 years) compared with low education (<16 years) (37.5% vs 4.1%) had greater reduction in pain intensity (p = 0.01). Conclusion These findings support the feasibility and efficacy of home-based self-delivered mirror therapy; this low-cost treatment may defray medical costs, therapy visits, and the patient travel burden for people with motivation and a high level of education. More research is needed to determine methods of cost-effective support for people with lower levels of education. PMID:22378591

Analytic validation and real-time clinical application of an amplicon-based targeted gene panel for advanced cancer

PubMed Central

Wing, Michele R.; Reeser, Julie W.; Smith, Amy M.; Reeder, Matthew; Martin, Dorrelyn; Jewell, Benjamin M.; Datta, Jharna; Miya, Jharna; Monk, J. Paul; Mortazavi, Amir; Otterson, Gregory A.; Goldberg, Richard M.; VanDeusen, Jeffrey B.; Cole, Sharon; Dittmar, Kristin; Jaiswal, Sunny; Kinzie, Matthew; Waikhom, Suraj; Freud, Aharon G.; Zhou, Xiao-Ping; Chen, Wei; Bhatt, Darshna; Roychowdhury, Sameek

2017-01-01

Multiplex somatic testing has emerged as a strategy to test patients with advanced cancer. We demonstrate our analytic validation approach for a gene hotspot panel and real-time prospective clinical application for any cancer type. The TruSight Tumor 26 assay amplifies 85 somatic hotspot regions across 26 genes. Using cell line and tumor mixes, we observed that 100% of the 14,715 targeted bases had at least 1000x raw coverage. We determined the sensitivity (100%, 95% CI: 96-100%), positive predictive value (100%, 95% CI: 96-100%), reproducibility (100% concordance), and limit of detection (3% variant allele frequency at 1000x read depth) of this assay to detect single nucleotide variants and small insertions and deletions. Next, we applied the assay prospectively in a clinical tumor sequencing study to evaluate 174 patients with metastatic or advanced cancer, including frozen tumors, formalin-fixed tumors, and enriched peripheral blood mononuclear cells in hematologic cancers. We reported one or more somatic mutations in 89 (53%) of the sequenced tumors (167 passing quality filters). Forty-three of these patients (26%) had mutations that would enable eligibility for targeted therapies. This study demonstrates the validity and feasibility of applying TruSight Tumor 26 for pan-cancer testing using multiple specimen types. PMID:29100271

A pilot prospective feasibility study of organ-at-risk definition using Target Contour Testing/Instructional Computer Software (TaCTICS), a training and evaluation platform for radiotherapy target delineation.

PubMed

Kalpathy-Cramer, Jayashree; Bedrick, Steven D; Boccia, Kelly; Fuller, Clifton D

2011-01-01

Target volume delineation is a critical, but time-consuming step in the creation of radiation therapy plans used in the treatment of many types of cancer. However, variability in target volume definitions can introduce substantial differences in resulting doses to tumors and critical structures. We developed TaCTICS, a web-based educational training software application targeted towards non-expert users. We report on a small, prospective study to evaluate the utility of this online tool in improving conformance of regions-of-interest (ROIs) with a reference set. Eight residents contoured a set of structures for a head-and-neck cancer case. Subsequently, they were provided access to TaCTICS as well as contouring atlases to allow evaluation of their contours in reference to other users as well as reference ROIs. The residents then contoured a second case using these resources. Volume overlap metrics between the users showed a substantial improvement following the intervention. Additionally, 66% of users reported that they found TaCTICS to be a useful educational tool and all participants reported they would like to use TaCTICS to track their contouring skills over the course of their residency.

Properties of an entropy-based signal receiver with an application to ultrasonic molecular imaging.

PubMed

Hughes, M S; McCarthy, J E; Marsh, J N; Arbeit, J M; Neumann, R G; Fuhrhop, R W; Wallace, K D; Znidersic, D R; Maurizi, B N; Baldwin, S L; Lanza, G M; Wickline, S A

2007-06-01

Qualitative and quantitative properties of the finite part, H(f), of the Shannon entropy of a continuous waveform f(t) in the continuum limit are derived in order to illuminate its use for waveform characterization. Simple upper and lower bounds on H(f), based on features of f(t), are defined. Quantitative criteria for a priori estimation of the average-case variation of H(f) and log E(f), where E(f) is the signal energy of f(t) are also derived. These provide relative sensitivity estimates that could be used to prospectively choose optimal imaging strategies in real-time ultrasonic imaging machines, where system bandwidth is often pushed to its limits. To demonstrate the utility of these sensitivity relations for this application, a study designed to assess the feasibility of identification of angiogenic neovasculature targeted with perfluorocarbon nanoparticles that specifically bind to alpha(v)beta3-integrin expression in tumors was performed. The outcome of this study agrees with the prospective sensitivity estimates that were used for the two receivers. Moreover, these data demonstrate the ability of entropy-based signal receivers when used in conjunction with targeted nanoparticles to elucidate the presence of alpha(v)beta3 integrins in primordial neovasculature, particularly in acoustically unfavorable environments.

Effectiveness of the Surgery Core Clerkship Flipped Classroom: a prospective cohort trial.

PubMed

Liebert, Cara A; Lin, Dana T; Mazer, Laura M; Bereknyei, Sylvia; Lau, James N

2016-02-01

The flipped classroom has been proposed as an alternative curricular approach to traditional didactic lectures but has not been previously applied to a surgery clerkship. A 1-year prospective cohort of students (n = 89) enrolled in the surgery clerkship was taught using a flipped classroom approach. A historical cohort of students (n = 92) taught with a traditional lecture curriculum was used for comparison. Pretest and post-test performance, end-of-clerkship surveys, and National Board of Medical Examiners (NBME) scores were analyzed to assess effectiveness. Mean pretest and post-test scores increased across all modules (P < .001). There was no difference between mean NBME examination score in the prospective and historical cohorts (74.75 vs 75.74, P = .28). Mean ratings of career interest in surgery increased after curriculum completion (4.75 to 6.50, P < .001), with 90% reporting that the flipped classroom contributed to this increase. Implementation of a flipped classroom in the surgery clerkship is feasible and results in high learner satisfaction, effective knowledge acquisition, and increased career interest in surgery with noninferior NBME performance. Copyright © 2016 Elsevier Inc. All rights reserved.

Biotransformation of carbon dioxide in bioelectrochemical systems: State of the art and future prospects

NASA Astrophysics Data System (ADS)

Bajracharya, Suman; Srikanth, Sandipam; Mohanakrishna, Gunda; Zacharia, Renju; Strik, David PBTB; Pant, Deepak

2017-07-01

Carbon dioxide (CO2) utilization/recycling for the production of chemicals and gaseous/liquid energy-carriers is a way to moderate the rising CO2 in the atmosphere. One of the possible solutions for the CO2 sequestration is the electrochemical reduction of this stable molecule to useful fuel/products. Nevertheless, the surface chemistry of CO2 reduction is a challenge due to the presence of large energy barriers, requiring noticeable catalysis. The recent approach of microbial electrocatalysis of CO2 reduction has promising prospects to reduce the carbon level sustainably, taking full advantage of CO2-derived chemical commodities. We review the currently investigated bioelectrochemical approaches that could possibly be implemented to enable the handling of CO2 emissions. This review covers the most recent advances in the bioelectrochemical approaches of CO2 transformations in terms of biocatalysts development and process design. Furthermore, the extensive research on carbon fixation and conversion to different value added chemicals is reviewed. The review concludes by detailing the key challenges and future prospects that could enable economically feasible microbial electrosynthesis technology.