Examining the safety of menstrual cups among rural primary school girls in western Kenya: observational studies nested in a randomised controlled feasibility study

PubMed Central

Juma, Jane; Nyothach, Elizabeth; Laserson, Kayla F; Oduor, Clifford; Arita, Lilian; Ouma, Caroline; Oruko, Kelvin; Omoto, Jackton; Mason, Linda; Alexander, Kelly T; Fields, Barry; Onyango, Clayton; Phillips-Howard, Penelope A

2017-01-01

Objective Examine the safety of menstrual cups against sanitary pads and usual practice in Kenyan schoolgirls. Design Observational studies nested in a cluster randomised controlled feasibility study. Setting 30 primary schools in a health and demographic surveillance system in rural western Kenya. Participants Menstruating primary schoolgirls aged 14–16 years participating in a menstrual feasibility study. Interventions Insertable menstrual cup, monthly sanitary pads or ‘usual practice’ (controls). Outcome measures Staphylococcus aureus vaginal colonization, Escherichia coli growth on sampled used cups, toxic shock syndrome or other adverse health outcomes. Results Among 604 eligible girls tested, no adverse event or TSS was detected over a median 10.9 months follow-up. S. aureusprevalence was 10.8%, with no significant difference over intervention time or between groups. Of 65 S.aureus positives at first test, 49 girls were retested and 10 (20.4%) remained positive. Of these, two (20%) sample isolates tested positive for toxic shock syndrome toxin-1; both girls were provided pads and were clinically healthy. Seven per cent of cups required replacements for loss, damage, dropping in a latrine or a poor fit. Of 30 used cups processed for E. coli growth, 13 (37.1%, 95% CI 21.1% to 53.1%) had growth. E. coli growth was greatest in newer compared with established users (53%vs22.2%, p=0.12). Conclusions Among this feasibility sample, no evidence emerged to indicate menstrual cups are hazardous or cause health harms among rural Kenyan schoolgirls, but large-scale trials and post-marketing surveillance should continue to evaluate cup safety. PMID:28473520

Assessing the safety culture of care homes: a multimethod evaluation of the adaptation, face validity and feasibility of the Manchester Patient Safety Framework.

PubMed

Marshall, Martin; Cruickshank, Lesley; Shand, Jenny; Perry, Sarah; Anderson, James; Wei, Li; Parker, Dianne; de Silva, Debra

2017-09-01

Understanding the cultural characteristics of healthcare organisations is widely recognised to be an important component of patient safety. A growing number of vulnerable older people are living in care homes but little attention has been paid to safety culture in this sector. In this study, we aimed to adapt the Manchester Patient Safety Framework (MaPSaF), a commonly used tool in the health sector, for use in care homes and then to test its face validity and preliminary feasibility as a tool for developing a better understanding of safety culture in the sector. As part of a wider improvement programme to reduce the prevalence of common safety incidents among residents in 90 care homes in England, we adapted MaPSaF and carried out a multimethod participatory evaluation of its face validity and feasibility for care home staff. Data were collected using participant observation, interviews, documentary analysis and a survey, and were analysed thematically. MaPSaF required considerable adaptation in terms of its length, language and content in order for it to be perceived to be acceptable and useful to care home staff. The changes made reflected differences between the health and care home sectors in terms of the local context and wider policy environment, and the expectations, capacity and capabilities of the staff. Based on this preliminary study, the adapted tool, renamed 'Culture is Key', appears to have reasonable face validity and, with adequate facilitation, it is usable by front-line staff and useful in raising their awareness about safety issues. 'Culture is Key' is a new tool which appears to have acceptable face validity and feasibility to be used by care home staff to deepen their understanding of the safety culture of their organisations and therefore has potential to contribute to improving care for vulnerable older people. 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/.

Examining the safety of menstrual cups among rural primary school girls in western Kenya: observational studies nested in a randomised controlled feasibility study.

PubMed

Juma, Jane; Nyothach, Elizabeth; Laserson, Kayla F; Oduor, Clifford; Arita, Lilian; Ouma, Caroline; Oruko, Kelvin; Omoto, Jackton; Mason, Linda; Alexander, Kelly T; Fields, Barry; Onyango, Clayton; Phillips-Howard, Penelope A

2017-05-04

Examine the safety of menstrual cups against sanitary pads and usual practice in Kenyan schoolgirls. Observational studies nested in a cluster randomised controlled feasibility study. 30 primary schools in a health and demographic surveillance system in rural western Kenya. Menstruating primary schoolgirls aged 14-16 years participating in a menstrual feasibility study. Insertable menstrual cup, monthly sanitary pads or 'usual practice' (controls). Staphylococcus aureus vaginal colonization, Escherichia coli growth on sampled used cups, toxic shock syndrome or other adverse health outcomes. Among 604 eligible girls tested, no adverse event or TSS was detected over a median 10.9 months follow-up. S. aureus prevalence was 10.8%, with no significant difference over intervention time or between groups. Of 65  S.aureus positives at first test, 49 girls were retested and 10 (20.4%) remained positive. Of these, two (20%) sample isolates tested positive for toxic shock syndrome toxin-1; both girls were provided pads and were clinically healthy. Seven per cent of cups required replacements for loss, damage, dropping in a latrine or a poor fit. Of 30 used cups processed for E. coli growth, 13 (37.1%, 95% CI 21.1% to 53.1%) had growth. E. coli growth was greatest in newer compared with established users (53%vs22.2%, p=0.12). Among this feasibility sample, no evidence emerged to indicate menstrual cups are hazardous or cause health harms among rural Kenyan schoolgirls, but large-scale trials and post-marketing surveillance should continue to evaluate cup safety. © 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.

Older, vulnerable patient view: a pilot and feasibility study of the patient measure of safety (PMOS) with patients in Australia.

PubMed

Taylor, Natalie; Hogden, Emily; Clay-Williams, Robyn; Li, Zhicheng; Lawton, Rebecca; Braithwaite, Jeffrey

2016-06-08

The UK-developed patient measure of safety (PMOS) is a validated tool which captures patient perceptions of safety in hospitals. We aimed (1) to investigate the extent to which the PMOS is appropriate for use with stroke, acute myocardial infarction (AMI) and hip fracture patients in Australian hospitals and (2) to pilot the PMOS for use in a large-scale, national study 'Deepening our Understanding of Quality in Australia' (DUQuA). Stroke, AMI and hip fracture patients (n=34) receiving care in 3 wards in 1 large hospital. 2 phases were conducted. First, a 'think aloud' study was used to determine the validity of PMOS with this population in an international setting, and to make amendments based on patient feedback. The second phase tested the revised measure to establish the internal consistency reliability of the revised subscales, and piloted the recruitment and administration processes to ensure feasibility of the PMOS for use in DUQuA. Of the 43 questions in the PMOS, 13 (30%) were amended based on issues patients highlighted for improvement in phase 1. In phase 2, a total of 34 patients were approached and 29 included, with a mean age of 71.3 years (SD=16.39). Internal consistency reliability was established using interitem correlation and Cronbach's α for all but 1 subscale. The most and least favourably rated aspects of safety differed between the 3 wards. A study log was categorised into 10 key feasibility factors, including liaising with wards to understand operational procedures and identify patterns of patient discharge. Capturing patient perceptions of care is crucial in improving patient safety. The revised PMOS is appropriate for use with vulnerable older adult groups. The findings from this study have informed key decisions made for the deployment of this measure as part of the DUQuA study. 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/

Feasibility, safety and outcomes of playing Kinect Adventures!™ for people with Parkinson's disease: a pilot study.

PubMed

Pompeu, J E; Arduini, L A; Botelho, A R; Fonseca, M B F; Pompeu, S M A A; Torriani-Pasin, C; Deutsch, J E

2014-06-01

To assess the feasibility, safety and outcomes of playing Microsoft Kinect Adventures™ for people with Parkinson's disease in order to guide the design of a randomised clinical trial. Single-group, blinded trial. Rehabilitation Center of São Camilo University, Brazil. Seven patients (six males, one female) with Parkinson's disease (Hoehn and Yahr Stages 2 and 3). Fourteen 60-minute sessions, three times per week, playing four games of Kinect Adventures! The feasibility and safety outcomes were patients' game performance and adverse events, respectively. The clinical outcomes were the 6-minute walk test, Balance Evaluation System Test, Dynamic Gait Index and Parkinson's Disease Questionnaire (PDQ-39). Patients' scores for the four games showed improvement. The mean [standard deviation (SD)] scores in the first and last sessions of the Space Pop game were 151 (36) and 198 (29), respectively [mean (SD) difference 47 (7), 95% confidence interval 15 to 79]. There were no adverse events. Improvements were also seen in the 6-minute walk test, Balance Evaluation System Test, Dynamic Gait Index and PDQ-39 following training. Kinect-based training was safe and feasible for people with Parkinson's disease (Hoehn and Yahr Stages 2 and 3). Patients improved their scores for all four games. No serious adverse events occurred during training with Kinect Adventures!, which promoted improvement in activities (balance and gait), body functions (cardiopulmonary aptitude) and participation (quality of life). Copyright © 2013 Chartered Society of Physiotherapy. Published by Elsevier Ltd. All rights reserved.

Feasibility and safety of augmented reality-assisted urological surgery using smartglass.

PubMed

Borgmann, H; Rodríguez Socarrás, M; Salem, J; Tsaur, I; Gomez Rivas, J; Barret, E; Tortolero, L

2017-06-01

To assess the feasibility, safety and usefulness of augmented reality-assisted urological surgery using smartglass (SG). Seven urological surgeons (3 board urologists and 4 urology residents) performed augmented reality-assisted urological surgery using SG for 10 different types of operations and a total of 31 urological operations. Feasibility was assessed using technical metadata (number of photographs taken/number of videos recorded/video time recorded) and structured interviews with the urologists on their use of SG. Safety was evaluated by recording complications and grading according to the Clavien-Dindo classification. Usefulness of SG for urological surgery was queried in structured interviews and in a survey. The implementation of SG use during urological surgery was feasible with no intrinsic (technical defect) or extrinsic (inability to control the SG function) obstacles being observed. SG use was safe as no grade 3-5 complications occurred for the series of 31 urological surgeries of different complexities. Technical applications of SG included taking photographs/recording videos for teaching and documentation, hands-free teleconsultation, reviewing patients' medical records and images and searching the internet for health information. Overall usefulness of SG for urological surgery was rated as very high by 43 % and high by 29 % of surgeons. Augmented reality-assisted urological surgery using SG is both feasible and safe and also provides several useful functions for urological surgeons. Further developments and investigations are required in the near future to harvest the great potential of this exciting technology for urological surgery.

The safety and feasibility of probiotics in children and adolescents undergoing hematopoietic cell transplantation.

PubMed

Ladas, E J; Bhatia, M; Chen, L; Sandler, E; Petrovic, A; Berman, D M; Hamblin, F; Gates, M; Hawks, R; Sung, L; Nieder, M

2016-02-01

Hematopoietic cell transplantation (HCT) has become a standard treatment for many adult and pediatric conditions. Emerging evidence suggests that perturbations in the microbiota diversity increase recipients' susceptibilities to gut-mediated conditions such as diarrhea, infection and acute GvHD. Probiotics preserve the microbiota and may minimize the risk of developing a gut-mediated condition; however, their safety has not been evaluated in the setting of HCT. We evaluated the safety and feasibility of the probiotic, Lactobacillus plantarum (LBP), in children and adolescents undergoing allogeneic HCT. Participants received once-daily supplementation with LBP beginning on day -8 or -7 and continued until day +14. Outcomes were compliance with daily administration and incidence of LBP bacteremia. Administration of LBP was feasible with 97% (30/31, 95% confidence interval (CI) 83-100%) of children receiving at least 50% of the probiotic dose (median 97%; range 50-100%). We did not observe any case of LBP bacteremia (0% (0/30) with 95% CI 0-12%). There were not any unexpected adverse events related to LBP. Our study provides preliminary evidence that administration of LBP is safe and feasible in children and adolescents undergoing HCT. Future steps include the conduct of an approved randomized, controlled trial through Children's Oncology Group.

Feasibility and safety of general anesthesia for bronchial thermoplasty: a description of early 10 treatments.

PubMed

Aizawa, Mariko; Ishihara, Satoshi; Yokoyama, Takeshi; Katayama, Katsuyuki

2018-03-20

Bronchial thermoplasty (BT) is a recently introduced bronchoscopic treatment for patients with asthma refractory to pharmacotherapy. Intraprocedural sedation management is important for successful performance of BT. However, the results of general anesthesia in patients undergoing BT have not been well described. The aim of this study was to evaluate the feasibility and safety of general anesthesia in patients undergoing BT. We retrospectively reviewed the records of 10 consecutive BT treatments performed under general anesthesia in 4 patients. The feasibility outcomes were coughing and body movement during the procedure, procedure abandonment, and the relative frequency of thermal activation failure. The safety outcomes were bronchospasm and hypoxemia during the procedure, respiratory symptoms, and the need for oxygen after the procedure. Coughing occurred in two treatments. Neither body movement nor procedure abandonment occurred in any treatments. Neither intraprocedural bronchospasm nor hypoxemia occurred in any treatments. Respiratory symptoms occurred in 7 of 10 treatments within 1 day after the procedure and resolved within 4 days, which is comparable with a previous report. These results indicate that general anesthesia is feasible and safe for patients undergoing BT.

Safety and feasibility evaluation of tourniquets for total knee replacement (SAFE-TKR): study protocol.

PubMed

Wall, Peter Dh; Ahmed, Imran; Metcalfe, Andrew; Price, Andrew J; Seers, Kate; Hutchinson, Charles E; Parsons, Helen; Warwick, Jane; Rahman, Bushra; Brown, Jaclyn; Underwood, Martin

2018-04-10

This study is designed to determine whether a full randomised controlled trial (RCT) examining the clinical effectiveness and safety of total knee replacement surgery with or without a tourniquet is warranted and feasible. Single centre, patient-blinded and assessor-blinded RCT. A computer-generated randomisation service will allocate 50 participants into one of two trial treatments, surgery with or without a tourniquet. The primary objective is to estimate recruitment, crossovers and follow-up of patients. All patients will have an MRI scan of their brain preoperatively and day 1 or 2 postoperatively to identify ischaemic cerebral emboli (primary clinical outcome). Oxford Cognitive Screen, Montreal Cognitive Assessment and Mini-Mental State Examination will be evaluated as outcome tools for measuring cognitive impairment at days 1, 2 and 7 postoperatively. Thigh pain, blood transfusion requirements, venous thromboembolism, revision surgery, surgical complications, mortality and Oxford knee and five-level EuroQol-5D scores will be collected over 12 months. Integrated qualitative research study : 30 trial patients and 20 knee surgeons will take part in semistructured interviews. Interviews will capture views regarding the pilot trial and explore barriers and potential solutions to a full trial. Multicentre cohort study : UK National Joint Registry data will be linked to Hospital Episode Statistics to estimate the relationship between tourniquet use and venous thromboembolic event, length of hospital stay, risk of revision surgery and death. The study will conclude with a multidisciplinary workshop to reach a consensus on whether a full trial is warranted and feasible. National Research Ethics Committee (West Midlands-Edgbaston) approved this study on 27 January 2016 (15/WM/0455). The study is sponsored by University of Warwick and University Hospitals Coventry and Warwickshire. The results will be disseminated via high-impact peer-reviewed publication. ISRCTN

Feasibility and Safety of Intra-Dialysis Yoga and Education in Maintenance Hemodialysis Patients

PubMed Central

Birdee, Gurjeet S.; Rothman, Russell L.; Sohl, Stephanie J.; Wertenbaker, Dolphi; Wheeler, Amy; Bossart, Chase; Balasire, Oluwaseyi; Ikizler, T. Alp

2016-01-01

Objective Patients with end-stage renal disease on maintenance hemodialysis are much more sedentary than healthy individuals. The purpose of this study was to assess the feasibility and safety of a 12-week intra-dialysis yoga intervention versus a kidney education intervention on the promotion of physical activity. Design and Methods We randomized participants by dialysis shift to either 12-week intra-dialysis yoga or an educational intervention. Intra-dialysis yoga was provided by yoga teachers to participants while receiving hemodialysis. Participants receiving the 12-week educational intervention received a modification of a previously developed comprehensive educational program for patients with kidney disease (“Kidney School”). The primary outcome for this study was feasibility based on recruitment and adherence to the interventions, and safety of intra-dialysis yoga. Secondary outcomes were to determine the feasibility of administering questionnaires at baseline and 12-weeks including the Kidney Disease-Related Quality of Life-36. Results Among 56 eligible patients approached for the study, 55% (n=31) were interested and consented to participation with 18 assigned to intra-dialysis yoga and 13 to the educational program. A total of 5 participants withdrew from the pilot study, all from the intra-dialysis yoga group. Two of these participants reported no further interest in participation. Three withdrawn participants switched dialysis times and therefore could no longer receive intra-dialysis yoga. As a result, 72% (13 of 18) and 100% (13 of 13) of participants completed 12-week intra-dialysis yoga and educational programs, respectively. There were no adverse events related to intra-dialysis yoga. Intervention participants practiced yoga a median of 21 sessions (70% participation frequency), with 60% of participants practicing at least 2 times a week. Participants in the educational program completed a median of 30 sessions (83% participation frequency

Safety and Feasibility of Topical Application of Limonene as a Massage Oil to the Breast.

PubMed

Miller, Jessica A; Thompson, Patricia A; Hakim, Iman A; Lopez, Ana Maria; Thomson, Cynthia A; Chew, Wade; Hsu, Chiu-Hsieh; Chow, H-H Sherry

2012-10-01

Limonene, a major component in citrus oil, has demonstrated anti-cancer effects in preclinical mammary cancer models. However, the effective oral dose translates to a human dose that may not be feasible for chronic dosing. We proposed to evaluate topical application of limonene to the breast as an alternative dosing strategy. We conducted a mouse disposition study to determine whether limonene would be bio available in the mammary tissue after topical application. SKH-1 mice received topical or oral administration of limonene in the form of orange oil every day for 4 weeks. Plasma and mammary pads were collected 4 hrs after the final dosing. We also conducted an exploratory clinical study to evaluate the safety and feasibility of topically applied limonene in the form of orange oil to the breast. Healthy women were recruited to apply orange oil containing massage oil to their breasts daily for four weeks. Safety and feasibility were assessed by reported adverse events, clinical labs, and usage compliance. Pre and post-intervention nipple aspirate fluid (NAF) and plasma were collected for limonene concentration determination. The mouse disposition study showed that topical and oral orange oil administration resulted in similar mammary tissue disposition of limonene with no clinical signs of toxicity. In the clinical study, the topical application of limonene containing massage oil to the breast was found to be safe with high levels of usage compliance for daily application, although NAF and plasma limonene concentrations were not significantly changed after the massage oil application. Our studies showed that limonene is bio available in mammary tissue after topical orange oil application in mice and this novel route of administration to the breast is safe and feasible in healthy women.

Safety and Feasibility of Topical Application of Limonene as a Massage Oil to the Breast

PubMed Central

Miller, Jessica A.; Thompson, Patricia A.; Hakim, Iman A.; Lopez, Ana Maria; Thomson, Cynthia A.; Chew, Wade; Hsu, Chiu-Hsieh; Chow, H.-H. Sherry

2013-01-01

Background Limonene, a major component in citrus oil, has demonstrated anti-cancer effects in preclinical mammary cancer models. However, the effective oral dose translates to a human dose that may not be feasible for chronic dosing. We proposed to evaluate topical application of limonene to the breast as an alternative dosing strategy. Materials and Methods We conducted a mouse disposition study to determine whether limonene would be bio available in the mammary tissue after topical application. SKH-1 mice received topical or oral administration of limonene in the form of orange oil every day for 4 weeks. Plasma and mammary pads were collected 4 hrs after the final dosing. We also conducted an exploratory clinical study to evaluate the safety and feasibility of topically applied limonene in the form of orange oil to the breast. Healthy women were recruited to apply orange oil containing massage oil to their breasts daily for four weeks. Safety and feasibility were assessed by reported adverse events, clinical labs, and usage compliance. Pre and post-intervention nipple aspirate fluid (NAF) and plasma were collected for limonene concentration determination. Results The mouse disposition study showed that topical and oral orange oil administration resulted in similar mammary tissue disposition of limonene with no clinical signs of toxicity. In the clinical study, the topical application of limonene containing massage oil to the breast was found to be safe with high levels of usage compliance for daily application, although NAF and plasma limonene concentrations were not significantly changed after the massage oil application. Conclusions Our studies showed that limonene is bio available in mammary tissue after topical orange oil application in mice and this novel route of administration to the breast is safe and feasible in healthy women. PMID:24236248

Feasibility, safety and efficacy of transcutaneous vagus nerve stimulation in chronic tinnitus: an open pilot study.

PubMed

Kreuzer, Peter M; Landgrebe, Michael; Resch, Markus; Husser, Oliver; Schecklmann, Martin; Geisreiter, Florian; Poeppl, Timm B; Prasser, Sarah J; Hajak, Goeran; Rupprecht, Rainer; Langguth, Berthold

2014-01-01

Vagus nerve stimulation represents an established treatment strategy for epilepsy and affective disorders. Recently, positive effects were also shown in animals and humans with tinnitus. Here we report the results of an open pilot study exploring feasibility, safety and efficacy of tVNS in the treatment of chronic tinnitus. Fifty patients with chronic tinnitus underwent tVNS in an open single-armed pilot study which was conducted in two phases applying two different stimulating devices (Cerbomed CM02 and NEMOS). Clinical assessment was based on Tinnitus Questionnaire (TQ), Tinnitus Handicap Inventory (THI), Beck Depression Inventory (BDI), WHO Quality of Life, and various numeric rating scales. Primary outcome was defined as change in TQ (baseline vs. final visit in week 24). The study has been registered with clinicaltrials.gov (NCT01176734). Primary analysis indicated mean TQ reductions of 3.7 points (phase 1) and 2.8 points (phase 2) significant for the first study phase. Secondary analyses indicated a significant BDI reduction for phase 1 (uncorrected for multiple testing), but no further systematic or significant effects. Adverse events included twitching and pressure at electrode placement site. The occurrence of one hospitalization because of palpations and the development of a left bundle branch block were considered as unrelated to the intervention. Cognitive testing revealed no significant changes. Our data demonstrate the feasibility of tVNS over a period of 6 months. There was no clinically relevant improvement of tinnitus complaints. Our data suggest tVNS to be considered safe in patients without a history of cardiac disease. Copyright © 2014 Elsevier Inc. All rights reserved.

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.

da Vinci robot-assisted keyhole neurosurgery: a cadaver study on feasibility and safety.

PubMed

Marcus, Hani J; Hughes-Hallett, Archie; Cundy, Thomas P; Yang, Guang-Zhong; Darzi, Ara; Nandi, Dipankar

2015-04-01

The goal of this cadaver study was to evaluate the feasibility and safety of da Vinci robot-assisted keyhole neurosurgery. Several keyhole craniotomies were fashioned including supraorbital subfrontal, retrosigmoid and supracerebellar infratentorial. In each case, a simple durotomy was performed, and the flap was retracted. The da Vinci surgical system was then used to perform arachnoid dissection towards the deep-seated intracranial cisterns. It was not possible to simultaneously pass the 12-mm endoscope and instruments through the keyhole craniotomy in any of the approaches performed, limiting visualization. The articulated instruments provided greater dexterity than existing tools, but the instrument arms could not be placed in parallel through the keyhole craniotomy and, therefore, could not be advanced to the deep cisterns without significant clashing. The da Vinci console offered considerable ergonomic advantages over the existing operating room arrangement, allowing the operating surgeon to remain non-sterile and seated comfortably throughout the procedure. However, the lack of haptic feedback was a notable limitation. In conclusion, while robotic platforms have the potential to greatly enhance the performance of transcranial approaches, there is strong justification for research into next-generation robots, better suited to keyhole neurosurgery.

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

Study protocol for the FITR Heart Study: Feasibility, safety, adherence, and efficacy of high intensity interval training in a hospital-initiated rehabilitation program for coronary heart disease.

PubMed

Taylor, Jenna; Keating, Shelley E; Leveritt, Michael D; Holland, David J; Gomersall, Sjaan R; Coombes, Jeff S

2017-12-01

For decades, moderate intensity continuous training (MICT) has been the cornerstone of exercise prescription for cardiac rehabilitation (CR). High intensity interval training (HIIT) is now recognized in CR exercise guidelines as an appropriate and efficient modality for improving cardiorespiratory fitness, a strong predictor of mortality. However, the clinical application of HIIT in a real world CR setting, in terms of feasibility, safety, and long-term adherence, needs further investigation to address ongoing reservations. Furthermore, studies using objective measures of exercise intensity (such as heart rate; HR) have produced variable outcomes. Therefore we propose investigating the use of subjective measures (such as rating of perceived exertion (RPE)) for prescribing exercise intensity. One hundred adults with coronary artery disease (CAD) attending a hospital-initiated CR program will be randomized to 1) HIIT: 4 × 4 min high intensity intervals at 15-18 RPE interspersed with 3-min active recovery periods or 2) MICT: usual care exercise including 40 min continuous exercise at a moderate intensity corresponding to 11-13 RPE. Primary outcome is change in exercise capacity (peak VO 2 ) following 4 weeks of exercise training. Secondary outcome measures are: feasibility, safety, exercise adherence, body composition, vascular function, inflammatory markers, intrahepatic lipid, energy intake, and dietary behavior over 12-months; and visceral adipose tissue (VAT) following 12 weeks of exercise training. This study aims to address the ongoing concerns regarding the practicality and safety of HIIT in CR programs. We anticipate study findings will lead to the development of a standardized protocol to facilitate CR programs to incorporate HIIT as a standard exercise option for appropriate patients.

Feasibility and safety of virtual-reality-based early neurocognitive stimulation in critically ill patients.

PubMed

Turon, Marc; Fernandez-Gonzalo, Sol; Jodar, Mercè; Gomà, Gemma; Montanya, Jaume; Hernando, David; Bailón, Raquel; de Haro, Candelaria; Gomez-Simon, Victor; Lopez-Aguilar, Josefina; Magrans, Rudys; Martinez-Perez, Melcior; Oliva, Joan Carles; Blanch, Lluís

2017-12-01

Growing evidence suggests that critical illness often results in significant long-term neurocognitive impairments in one-third of survivors. Although these neurocognitive impairments are long-lasting and devastating for survivors, rehabilitation rarely occurs during or after critical illness. Our aim is to describe an early neurocognitive stimulation intervention based on virtual reality for patients who are critically ill and to present the results of a proof-of-concept study testing the feasibility, safety, and suitability of this intervention. Twenty critically ill adult patients undergoing or having undergone mechanical ventilation for ≥24 h received daily 20-min neurocognitive stimulation sessions when awake and alert during their ICU stay. The difficulty of the exercises included in the sessions progressively increased over successive sessions. Physiological data were recorded before, during, and after each session. Safety was assessed through heart rate, peripheral oxygen saturation, and respiratory rate. Heart rate variability analysis, an indirect measure of autonomic activity sensitive to cognitive demands, was used to assess the efficacy of the exercises in stimulating attention and working memory. Patients successfully completed the sessions on most days. No sessions were stopped early for safety concerns, and no adverse events occurred. Heart rate variability analysis showed that the exercises stimulated attention and working memory. Critically ill patients considered the sessions enjoyable and relaxing without being overly fatiguing. The results in this proof-of-concept study suggest that a virtual-reality-based neurocognitive intervention is feasible, safe, and tolerable, stimulating cognitive functions and satisfying critically ill patients. Future studies will evaluate the impact of interventions on neurocognitive outcomes. Trial registration Clinical trials.gov identifier: NCT02078206.

Feasibility and Safety of a Powered Exoskeleton for Assisted Walking for Persons With Multiple Sclerosis: A Single-Group Preliminary Study.

PubMed

Kozlowski, Allan J; Fabian, Michelle; Lad, Dipan; Delgado, Andrew D

2017-07-01

To examine the feasibility, safety, and secondary benefit potential of exoskeleton-assisted walking with one device for persons with multiple sclerosis (MS). Single-group longitudinal preliminary study with 8-week baseline, 8-week intervention, and 4-week follow-up. Outpatient MS clinic, tertiary care hospital. Participants (N=13; age range, 38-62y) were mostly women with Expanded Disability Status Scale scores ranging from 5.5 to 7.0. Exoskeleton-assisted walk training. Primary outcomes were accessibility (enrollment/screen pass), tolerability (completion/dropout), learnability (time to event for standing, walking, and sitting with little or no assistance), acceptability (satisfaction on the device subscale of the Quebec User Evaluation of Satisfaction with Assistive Technology version 2), and safety (event rates standardized to person-time exposure in the powered exoskeleton). Secondary outcomes were walking without the device (timed 25-foot walk test and 6-minute walk test distance), spasticity (Modified Ashworth Scale), and health-related quality of life (Patient-Reported Outcomes Measurement and Information System pain interference and Quality of Life in Neurological Conditions fatigue, sleep disturbance, depression, and positive affect and well-being). The device was accessible to 11 and tolerated by 5 participants. Learnability was moderate, with 5 to 15 sessions required to walk with minimal assistance. Safety was good; the highest adverse event rate was for skin issues at 151 per 1000 hours' exposure. Acceptability ranged from not very satisfied to very satisfied. Participants who walked routinely improved qualitatively on sitting, standing, or walking posture. Two participants improved and 2 worsened on ≥1 quality of life domain. The pattern of spasticity scores may indicate potential benefit. The device appeared feasible and safe for about a third of our sample, for whom routine exoskeleton-assisted walking may offer secondary benefits. Copyright �

Magnetic resonance imaging-compatible circular mapping catheter: an in vivo feasibility and safety study.

PubMed

Elbes, Delphine; Magat, Julie; Govari, Assaf; Ephrath, Yaron; Vieillot, Delphine; Beeckler, Christopher; Weerasooriya, Rukshen; Jais, Pierre; Quesson, Bruno

2017-03-01

Interventional cardiac catheter mapping is routinely guided by X-ray fluoroscopy, although radiation exposure remains a significant concern. Feasibility of catheter ablation for common flutter has recently been demonstrated under magnetic resonance imaging (MRI) guidance. The benefit of catheter ablation under MRI could be significant for complex arrhythmias such as atrial fibrillation (AF), but MRI-compatible multi-electrode catheters such as Lasso have not yet been developed. This study aimed at demonstrating the feasibility and safety of using a multi-electrode catheter [magnetic resonance (MR)-compatible Lasso] during MRI for cardiac mapping. We also aimed at measuring the level of interference between MR and electrophysiological (EP) systems. Experiments were performed in vivo in sheep (N = 5) using a multi-electrode, circular, steerable, MR-compatible diagnostic catheter. The most common MRI sequences (1.5T) relevant for cardiac examination were run with the catheter positioned in the right atrium. High-quality electrograms were recorded while imaging with a maximal signal-to-noise ratio (peak-to-peak signal amplitude/peak-to-peak noise amplitude) ranging from 5.8 to 165. Importantly, MRI image quality was unchanged. Artefacts induced by MRI sequences during mapping were demonstrated to be compatible with clinical use. Phantom data demonstrated that this 10-pole circular catheter can be used safely with a maximum of 4°C increase in temperature. This new MR-compatible 10-pole catheter appears to be safe and effective. Combining MR and multipolar EP in a single session offers the possibility to correlate substrate information (scar, fibrosis) and EP mapping as well as online monitoring of lesion formation and electrical endpoint. Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2016. For permissions please email: journals.permissions@oup.com.

A Study in Iowa. Teaching Food Safety in Secondary FCS Classes

ERIC Educational Resources Information Center

Ellis, Jason D.; Henroid, Daniel H., Jr.

2005-01-01

Food safety is a significant issue in the United States and yet minimal research has been done on the inclusion of food safety in secondary school curricula. This study examined the feasibility of including food safety in Iowa FCS middle and secondary classes. Teachers reported food safety was important; only a few believed students were…

An Investigation of Feasibility and Safety of Bi-Modal Stimulation for the Treatment of Tinnitus: An Open-Label Pilot Study.

PubMed

Hamilton, Caroline; D'Arcy, Shona; Pearlmutter, Barak A; Crispino, Gloria; Lalor, Edmund C; Conlon, Brendan J

2016-12-01

Tinnitus is the perception of sound in the absence of an external auditory stimulus. It is widely believed that tinnitus, in patients with associated hearing loss, is a neurological phenomenon primarily affecting the central auditory structures. However, there is growing evidence for the involvement of the somatosensory system in this form of tinnitus. For this reason it has been suggested that the condition may be amenable to bi-modal stimulation of the auditory and somatosensory systems. We conducted a pilot study to investigate the feasibility and safety of a device that delivers simultaneous auditory and somatosensory stimulation to treat the symptoms of chronic tinnitus. A cohort of 54 patients used the stimulation device for 10 weeks. Auditory stimulation was delivered via headphones and somatosensory stimulation was delivered via electrical stimulation of the tongue. Patient usage, logged by the device, was used to classify patients as compliant or noncompliant. Safety was assessed by reported adverse events and changes in tinnitus outcome measures. Response to treatment was assessed using tinnitus outcome measures: Minimum Masking Level (MML), Tinnitus Loudness Matching (TLM), and Tinnitus Handicap Inventory (THI). The device was well tolerated by patients and no adverse events or serious difficulties using the device were reported. Overall, 68% of patients met the defined compliance threshold. Compliant patients (N = 30) demonstrated statistically significant improvements in mean outcome measures after 10 weeks of treatment: THI (-11.7 pts, p < 0.001), TLM (-7.5dB, p < 0.001), and MML (-9.7dB, p < 0.001). The noncompliant group (N = 14) demonstrated no statistical improvements. This study demonstrates the feasibility and safety of a new bi-modal stimulation device and supports the potential efficacy of this new treatment for tinnitus. © 2016 Neuromod Devices Ltd. Neuromodulation: Technology at the Neural Interface published by Wiley

Safety and Feasibility of Pleural Cryobiopsy Compared to Forceps Biopsy During Semi-rigid Pleuroscopy.

PubMed

Pathak, Vikas; Shepherd, Ray W; Hussein, Ehab; Malhotra, Rajiv

2017-06-01

Pleural biopsy is often obtained in patients with undiagnosed exudative pleural effusion during pleuroscopy. Standard forceps have been traditionally used for the biopsy. Cryoprobes are being increasingly used for transbronchial lung biopsy as they obtain larger specimens and have less crush artifact. However, the safety and feasibility of cryoprobe biopsy compared to standard forceps for pleural biopsy has not been fully assessed. The objective of this study was to demonstrate the safety and feasibility of cryoprobe biopsy in the pleural space using semi-rigid pleuroscopy. Patients with idiopathic exudative pleural effusions underwent pleuroscopy. The procedure was done in the endoscopy suite with full barrier precautions and moderate sedation. Pleural biopsies were initially taken with a 2.0-mm saw-toothed forceps followed by a 2.4-mm cryoprobe (ERBECRYO, ERBE, US). The freeze time for each biopsy was 3 s. There were a total of ten patients, five males and five females. The mean age was 69 years (SD ± 11 years). The mean number of biopsies taken from the parietal pleura using forceps was 4.5 (SD ± 1.5) vs. 3.7 (SD ± 1.4) using cryoprobe. The mean cumulative tissue volume with forceps biopsy was 80 cu. mm; the mean cumulative tissue volume with cryobiopsy was 320 cu. mm, p = 0.007. The diagnostic yields were similar in both the groups. There was no increased incidence of bleeding, chest wall injury, or pain using cryoprobe in any of the patients. The use of cryoprobe for parietal pleural biopsy via semi-rigid pleuroscopy was feasible and safe in this small pilot study.

AGRI Grain Power ethanol-for-fuel project feasibility-study report. Volume III. Project environmental/health/safety/ and socioeconomic

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

Not Available

1981-04-01

The AGRI GRAIN POWER (AGP) project, hereafter referred to as the Project, was formed to evaluate the commercial viability and assess the desireability of implementing a large grain based grass-roots anhydrous ethanol fuel project to be sited near Des Moines, Iowa. This report presents the results of a Project feasibility evaluation. The Project concept is based on involving a very strong managerial, financial and technical joint venture that is extremely expert in all facets of planning and implementing a large ethanol project; on locating the ethanol project at a highly desireable site; on utilizing a proven ethanol process; and onmore » developing a Project that is well suited to market requirements, resource availability and competitive factors. This volume contains the results of the environmental, health, safety, and socio-economic studies.« less

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

Safety and feasibility of fasting in combination with platinum-based chemotherapy.

PubMed

Dorff, Tanya B; Groshen, Susan; Garcia, Agustin; Shah, Manali; Tsao-Wei, Denice; Pham, Huyen; Cheng, Chia-Wei; Brandhorst, Sebastian; Cohen, Pinchas; Wei, Min; Longo, Valter; Quinn, David I

2016-06-10

Short-term starvation prior to chemotherapy administration protects mice against toxicity. We undertook dose-escalation of fasting prior to platinum-based chemotherapy to determine safety and feasibility in cancer patients. 3 cohorts fasted before chemotherapy for 24, 48 and 72 h (divided as 48 pre-chemo and 24 post-chemo) and recorded all calories consumed. Feasibility was defined as ≥ 3/6 subjects in each cohort consuming ≤ 200 kcal per 24 h during the fast period without excess toxicity. Oxidative stress was evaluated in leukocytes using the COMET assay. Insulin, glucose, ketones, insulin-like growth factor-1 (IGF-1) and IGF binding proteins (IGFBPs) were measured as biomarkers of the fasting state. The median age of our 20 subjects was 61, and 85 % were women. Feasibility criteria were met. Fasting-related toxicities were limited to ≤ grade 2, most commonly fatigue, headache, and dizziness. The COMET assay indicated reduced DNA damage in leukocytes from subjects who fasted for ≥48 h (p = 0.08). There was a non-significant trend toward less grade 3 or 4 neutropenia in the 48 and 72 h cohorts compared to 24 h cohort (p = 0.17). IGF-1 levels decreased by 30, 33 and 8 % in the 24, 48 and 72 h fasting cohorts respectively after the first fasting period. Fasting for 72 h around chemotherapy administration is safe and feasible for cancer patients. Biomarkers such as IGF-1 may facilitate assessment of differences in chemotherapy toxicity in subgroups achieving the physiologic fasting state. An onging randomized trial is studying the effect of 72 h of fasting. NCT00936364 , registered propectively on July 9, 2009.

Coronary arteriography in a district general hospital: feasibility, safety, and diagnostic accuracy.

PubMed Central

Ranjadayalan, K; Mills, P G; Sprigings, D C; Mourad, K; Magee, P; Timmis, A D

1990-01-01

OBJECTIVE--To determine the feasibility, safety, and diagnostic accuracy of coronary arteriography in the radiology department of a district general hospital using conventional fluoroscopy and videotape recording. DESIGN--Observational study of the feasibility and safety of coronary arteriography in a district general hospital and analysis of its diagnostic accuracy by prospective within patient comparison of the video recordings with cinearteriograms obtained in a catheter laboratory. SETTING--Radiology department of a district general hospital and the catheter laboratory of a cardiological referral centre. SUBJECTS--50 Patients with acute myocardial infarction treated with streptokinase who underwent coronary arteriography in a district general hospital three (two to five) days after admission. 45 Of these patients had repeat coronary arteriography after four (three to seven) days in the catheter laboratory of a cardiological referral centre. MAIN OUTCOME MEASURES--Incidence of complications associated with catheterisation and the sensitivity and specificity of video recordings in the district general hospital (judged by two experienced observers) for identifying the location and severity of coronary stenoses. RESULTS--Coronary arteriograms recorded on videotape in the district general hospital were obtained in 47 cases and apart from one episode of ventricular fibrilation (treated successfully by cardioversion) there were no complications of the procedure. 45 Patients were transferred for investigation in the catheter laboratory, providing 45 paired coronary arteriograms recorded on videotape and cine film. The specificity of the video recordings for identifying the location and severity of coronary stenoses was over 90%. Sensitivity, however, was lower and for one observer fell below 40% for lesions in the circumflex artery. A cardiothoracic surgeon judged that only nine of the 47 video recordings were adequate for assessing revascularisation requirements

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

Feasibility of multi-sector policy measures that create activity-friendly environments for children: results of a Delphi study.

PubMed

Aarts, Marie-Jeanne; Schuit, Albertine J; van de Goor, Ien Am; van Oers, Hans Am

2011-12-15

Although multi-sector policy is a promising strategy to create environments that stimulate physical activity among children, little is known about the feasibility of such a multi-sector policy approach. The aims of this study were: to identify a set of tangible (multi-sector) policy measures at the local level that address environmental characteristics related to physical activity among children; and to assess the feasibility of these measures, as perceived by local policy makers. In four Dutch municipalities, a Delphi study was conducted among local policy makers of different policy sectors (public health, sports, youth and education, spatial planning/public space, traffic and transportation, and safety). In the first Delphi round, respondents generated a list of possible policy measures addressing three environmental correlates of physical activity among children (social cohesion, accessibility of facilities, and traffic safety). In the second Delphi round, policy makers weighted different feasibility aspects (political feasibility, cultural/community acceptability, technical feasibility, cost feasibility, and legal feasibility) and assessed the feasibility of the policy measures derived from the first round. The third Delphi round was aimed at reaching consensus by feedback of group results. Finally, one overall feasibility score was calculated for each policy measure. Cultural/community acceptability, political feasibility, and cost feasibility were considered most important feasibility aspects. The Delphi studies yielded 16 feasible policy measures aimed at physical and social environmental correlates of physical activity among children. Less drastic policy measures were considered more feasible, whereas environmental policy measures were considered less feasible. This study showed that the Delphi technique can be a useful tool in reaching consensus about feasible multi-sector policy measures. The study yielded several feasible policy measures aimed at

Safety and feasibility of leadless pacemaker in patients undergoing atrioventricular node ablation for atrial fibrillation.

PubMed

Yarlagadda, Bharath; Turagam, Mohit K; Dar, Tawseef; Jangam, Pragna; Veerapaneni, Vaishnavi; Atkins, Donita; Bommana, Sudharani; Friedman, Paul; Deshmukh, Abhishek J; Doshi, Rahul; Reddy, Vivek Y; Dukkipati, Srinivas R; Natale, Andrea; Lakkireddy, Dhanunjaya

2018-03-01

Atrioventricular node (AVN) ablation and permanent pacing is an established strategy for rate control in the management of symptomatic atrial fibrillation (AF). Leadless pacemakers (LPs) can overcome some of the short-term and long-term limitations of conventional transvenous pacemakers (CTPs). The purpose of this study was to compare the feasibility and safety of LP with those of single-chamber CTP in patients with AF undergoing AVN ablation. We conducted a multicenter observational study of patients undergoing AVN ablation and pacemaker implantation (LP vs single-chamber CTP) between February 2014 and November 2016. The primary efficacy end points were acceptable sensing (R wave ≥5.0 mV) and pacing thresholds (≤2.0 V at 0.4 ms) at follow-up. Safety end points included device-related major and minor (early ≤1 month, late >1 month) adverse events. A total of 127 patients with LP (n = 60) and CTP (n = 67) were studied. The median follow-up was 12 months (interquartile range 12-18 months). Ninety-five percent of the LP group and 97% of the CTP group met the primary efficacy end point at follow-up (57 of 60 vs 65 of 67; P = .66). There was 1 major adverse event (loss of pacing and sensing) in the LP group and 2 (lead dislodgement) in the CTP group (1 of 60 vs 2 of 67; P = 1.00). There were 6 minor adverse events (5 early and 1 late) in the LP group and 3 (early) in the CTP group (6 of 60 vs 3 of 67; P = .30). Our results demonstrate the feasibility and safety of LP compared with CTP in patients undergoing AVN ablation for AF. Copyright © 2018 Heart Rhythm Society. Published by Elsevier Inc. All rights reserved.

Phase Two Feasibility Study for Software Safety Requirements Analysis Using Model Checking

NASA Technical Reports Server (NTRS)

Turgeon, Gregory; Price, Petra

2010-01-01

A feasibility study was performed on a representative aerospace system to determine the following: (1) the benefits and limitations to using SCADE , a commercially available tool for model checking, in comparison to using a proprietary tool that was studied previously [1] and (2) metrics for performing the model checking and for assessing the findings. This study was performed independently of the development task by a group unfamiliar with the system, providing a fresh, external perspective free from development bias.

An interactive distance solution for stroke rehabilitation in the home setting - A feasibility study.

PubMed

Palmcrantz, Susanne; Borg, Jörgen; Sommerfeld, Disa; Plantin, Jeanette; Wall, Anneli; Ehn, Maria; Sjölinder, Marie; Boman, Inga-Lill

2017-09-01

In this study an interactive distance solution (called the DISKO tool) was developed to enable home-based motor training after stroke. The overall aim was to explore the feasibility and safety of using the DISKO-tool, customized for interactive stroke rehabilitation in the home setting, in different rehabilitation phases after stroke. Fifteen patients in three different stages in the continuum of rehabilitation after stroke participated in a home-based training program using the DISKO-tool. The program included 15 training sessions with recurrent follow-ups by the integrated application for video communication with a physiotherapist. Safety and feasibility were assessed from patients, physiotherapists, and a technician using logbooks, interviews, and a questionnaire. Qualitative content analysis and descriptive statistics were used in the analysis. Fourteen out of 15 patients finalized the training period with a mean of 19.5 minutes spent on training at each session. The DISKO-tool was found to be useful and safe by patients and physiotherapists. This study demonstrates the feasibility and safety of the DISKO-tool and provides guidance in further development and testing of interactive distance technology for home rehabilitation, to be used by health care professionals and patients in different phases of rehabilitation after stroke.

Direct transcatheter aortic valve implantation with self-expandable bioprosthesis: feasibility and safety.

PubMed

Fiorina, Claudia; Maffeo, Diego; Curello, Salvatore; Lipartiti, Felicia; Chizzola, Giuliano; D'Aloia, Antonio; Adamo, Marianna; Mastropierro, Rosy; Gavazzi, Emanuele; Ciccarese, Camilla; Chiari, Ermanna; Ettori, Federica

2014-06-01

Balloon valvuloplasty has been considered a mandatory step of the transcatheter aortic valve implantation (TAVI), although it is not without risk. The aim of this work was to evaluate the feasibility and safety of TAVI performed without pre-dilation (direct TAVI) of the stenosed aortic valve. Between June 2012 and June 2013, 55 consecutive TAVI performed without pre-dilation at our institution using the self-expandable CoreValve prosthesis (Medtronic, Minneapolis, MN) were analyzed and compared with 45 pre-dilated TAVI performed the previous year. Inclusion criteria were a symptomatic and severe aortic stenosis. Exclusion criteria were defined as presence of pure aortic regurgitation, degenerated surgical bioprosthesis or bicuspid aortic valve and prior procedure of balloon aortic valvuloplasty performed as a bridge to TAVI. High-burden calcification in the device landing zone, assessed by CT scan, was found in most of the patients. The valve size implanted was similar in both groups. Device success was higher in direct TAVI (85%vs.64%,p=0.014), mostly driven by a significant lower incidence of paravalvular leak (PVL≥2;9%vs.33%,p=0.02). Safety combined end point at 30 days was similar in both groups. Compared to TAVI with pre-dilation, direct TAVI is feasible regardless of the presence of bulky calcified aortic valve and the valve size implanted. Device success was higher in direct TAVI, mostly driven by a lower incidence of paravalvular leak. Safety at 30 days was similar in two groups. Copyright © 2014 Elsevier Inc. All rights reserved.

Talonavicular joint arthroscopic portals: A cadaveric study of feasibility and safety.

PubMed

Xavier, Gabriel; Oliva, Xavier Martin; Rotinen, Mauri; Monzo, Mariano

2016-09-01

The objectives of the study were to evaluate the safety of hypothetical arthroscopic portals from talonavicular joint and to evaluate their reproducibility and enforceability. 19 cadaveric feet were marked and four arthroscopic portals were made (medial, dorsomedial, dorsolateral and lateral). The specimens were dissected in layers and the distances between neurovascular structures and the trocars were measured. Medial and dorsomedial portals were in average 8.3 and 8.7, respectively, to the saphenous vein and nerve. Dorsolateral portal was in average 8.1mm to the deep peroneal nerve and dorsalis pedis artery, and 9.1mm to the medial dorsal cutaneous branch of the superficial peroneal nerve. Lateral portal was in average 12.3mm to the intermediate dorsal cutaneous branch of the superficial peroneal nerve. Tested portals shown to have a good safety margin for the foot neurovascular deep dorsal structures and an acceptable safety margin for the superficial neurovascular structures. Copyright © 2015 European Foot and Ankle Society. Published by Elsevier Ltd. All rights reserved.

A feasibility study for Arizona's roadway safety management process using the Highway Safety Manual and SafetyAnalyst : final report.

DOT National Transportation Integrated Search

2016-07-01

To enable implementation of the American Association of State Highway Transportation (AASHTO) Highway Safety Manual using : SaftetyAnalyst (an AASHTOWare software product), the Arizona Department of Transportation (ADOT) studied the data assessment :...

The Feasibility and Oncological Safety of Axillary Reverse Mapping in Patients with Breast Cancer: A Systematic Review and Meta-Analysis of Prospective Studies

PubMed Central

Han, Chao; Yang, Ben; Zuo, Wen-Shu; Zheng, Gang; Yang, Li; Zheng, Mei-Zhu

2016-01-01

Objective The axillary reverse mapping (ARM) technique has recently been developed to prevent lymphedema by preserving the arm lymphatic drainage during sentinel lymph node biopsy (SLNB) or axillary lymph node dissection (ALND) procedures. The objective of this systematic review and meta-analysis was to evaluate the feasibility and oncological safety of ARM. Methods We searched Medline, Embase, Web of science, Scopus, and the Cochrane Library for relevant prospective studies. The identification rate of ARM nodes, the crossover rate of SLN-ARM nodes, the proportion of metastatic ARM nodes, and the incidence of complications were pooled into meta-analyses by the random-effects model. Results A total of 24 prospective studies were included into meta-analyses, of which 11 studies reported ARM during SLNB, and 18 studies reported ARM during SLNB. The overall identification rate of ARM nodes was 38.2% (95% CI 32.9%-43.8%) during SLNB and 82.8% (78.0%-86.6%) during ALND, respectively. The crossover rate of SLN-ARM nodes was 19.6% (95% CI 14.4%-26.1%). The metastatic rate of ARM nodes was 16.9% (95% CI 14.2%-20.1%). The pooled incidence of lymphedema was 4.1% (95% CI 2.9–5.9%) for patients undergoing ARM procedure. Conclusions The ARM procedure was feasible during ALND. Nevertheless, it was restricted by low identification rate of ARM nodes during SLNB. ARM was beneficial for preventing lymphedema. However, this technique should be performed with caution given the possibility of crossover SLN-ARM nodes and metastatic ARM nodes. ARM appeared to be unsuitable for patients with clinically positive breast cancer due to oncological safety concern. PMID:26919589

Treatment of Biliary Stricture After Live Donor Liver Transplantation With Combined Metal and Plastic Stent Insertion: A Feasibility and Safety Study.

PubMed

Parlak, Erkan; Koksal, Aydin Seref; Eminler, Ahmet Tarik; Toka, Bilal; Uslan, Mustafa Ihsan

2017-08-01

Fully covered self-expandable metal stents (Fc-SEMSs) have a challenging use in the treatment of anastomosis strictures after live donor liver transplantation (LDLT) because they can occlude secondary branch biliary ducts when placed above the biliary bifurcation. In this study, we evaluated the technical feasibility and safety of combining Fc-SEMSs with plastic stent(s) inserted to the secondary branch biliary ducts for the treatment of anastomosis stricture after LDLT. The study group included 22 patients (12 men, aged 51±11 years) with anastomotic biliary stricture after LDLT. A Fc-SEMS, 8 to 10 mm in diameter, was inserted to the straight, dilated main duct and plastic stent(s) were inserted to the secondary branches to avoid their occlusion. Stents were left in place for 2 months and removed with a stent retrieving forceps. Technical feasibilities, including technical success, successful removal, and adverse events of this novel strategy, were evaluated. Fc-SEMSs were successfuly deployed and removed in all of the cases. Three (13.6%) patients had pain requiring intravenous analgesia and Fc-SEMS had to be removed because of unbearable pain in one of them. Three (13.6%) patients developed cholangitis due to occlusion of unrecognized secondary branch biliary ducts. Primary stricture resolution rate was achieved in 17 (89.5%) of 19 patients. Recurrence was observed in 3 (17.6%) patients after a mean follow-up duration of 154.3±52.6 (range, 104-304) days. Combination of Fc-SEMS and plastic stent(s) is technically feasible and safe for the treatment of anastomotic biliary strictures after LDLT.

Bariatric Radioembolization: A Pilot Study on Technical Feasibility and Safety in a Porcine Model.

PubMed

Pasciak, Alexander S; Bourgeois, Austin C; Paxton, Ben E; Nodit, Laurentia; Coan, Patricia N; Kraitchman, Dara; Stinnett, Sandra S; Patel, Vijay M; Fu, Yingli; Adams, Joleen K; Tolbert, M Katherine; Lux, Cassie N; Arepally, Aravind; Bradley, Yong C

2016-10-01

To evaluate feasibility of left gastric artery (LGA) yttrium-90 ((90)Y) radioembolization as potential treatment for obesity in a porcine model. This study included 8 young female pigs (12-13 weeks, 21.8-28.1 kg). Six animals received infusions of (90)Y resin microspheres (46.3-105.1 MBq) into the main LGA and the gastric artery arising from the splenic artery. Animal weight and serum ghrelin were measured before treatment and weekly thereafter. Animals were euthanized 69-74 days after treatment, and histologic analyses of mucosal integrity and ghrelin immunoreactive cell density were performed. Superficial mucosal ulcerations < 3.0 cm(2) were noted in 5 of 6 treated animals. Ghrelin immunoreactive cell density was significantly lower in treated versus untreated animals in the stomach fundus (13.5 vs 34.8, P < .05) and stomach body (11.2 vs 19.8, P < .05). Treated animals gained less weight than untreated animals over the study duration (40.2 kg ± 5.4 vs 54.7 kg ± 6.5, P = .053). Average fundic parietal area (165 cm(2) vs 282 cm(2), P = .067) and average stomach weight (297.2 g vs 397.0 g, P = .067) were decreased in treated versus untreated animals. Trichrome staining revealed significantly more fibrosis in treatment animals compared with control animals (13.0 vs 8.6, P < .05). No significant differences were identified in plasma ghrelin concentrations (P = .24). LGA (90)Y radioembolization is promising as a potential treatment for obesity. A larger preclinical study is needed to evaluate the safety and efficacy of this procedure further. Copyright © 2016 SIR. Published by Elsevier Inc. All rights reserved.

A 12-week interdisciplinary rehabilitation trial in patients with gliomas - a feasibility study.

PubMed

Hansen, Anders; Søgaard, Karen; Minet, Lisbeth Rosenbek; Jarden, Jens Ole

2018-06-01

This report aims to assess the safety and feasibility of using an interdisciplinary rehabilitation intervention for a future randomized controlled trial in patients with gliomas in the initial treatment phase. We conducted an outpatient two-part rehabilitation intervention that involved six weeks of therapeutic supervised training (part one) and six weeks of unsupervised training in a local gym following a training protocol (part two). Predefined feasibility objectives of safety (100%), consent rate (>80%), drop-out (<20%), adherence (>80%) and patient satisfaction (>80%) was achieved at part one. However, the failure to meet predefined feasibility objectives of drop-out, adherence and patient satisfaction of the unsupervised intervention at part two have led to a protocol revision for a future randomized controlled trial. This study demonstrates that an intensive rehabilitation intervention of physical therapy and occupational therapy in the initial treatment phase of patients with gliomas whose Karnofsky performance status is ≥70 is safe and feasible, if relevant inclusion criteria and precautionary screening are made. With the revised protocol, we are confident that the foundation for conducting a successful randomized controlled trial among these vulnerable patients has been established. Implications for rehabilitation Brain tumors constitute some of the most challenging cancer diagnoses presenting for rehabilitation intervention. Patients with gliomas experiences limitations in physical functioning, cognition, and emotional wellbeing. In a relatively small sample this study shows that supervised physical- and occupational therapy in patients with gliomas is safe and feasible in the initial treatment phase. Patients with gliomas can potentially improve functioning through interdisciplinary rehabilitation.

Feasibility, safety, and efficacy of aerobic training in pretreated patients with metastatic breast cancer: A randomized controlled trial.

PubMed

Scott, Jessica M; Iyengar, Neil M; Nilsen, Tormod S; Michalski, Meghan; Thomas, Samantha M; Herndon, James; Sasso, John; Yu, Anthony; Chandarlapaty, Sarat; Dang, Chau T; Comen, Elizabeth A; Dickler, Maura N; Peppercorn, Jeffrey M; Jones, Lee W

2018-04-06

The investigation of exercise training in metastatic breast cancer has received minimal attention. This study determined the feasibility and safety of aerobic training in metastatic breast cancer. Sixty-five women (age, 21-80 years) with metastatic (stage IV) breast cancer (57% were receiving chemotherapy, and >40% had ≥ 2 lines of prior therapy) were allocated to an aerobic training group (n = 33) or a stretching group (n = 32). Aerobic training consisted of 36 supervised treadmill walking sessions delivered thrice weekly between 55% and 80% of peak oxygen consumption (VO 2peak ) for 12 consecutive weeks. Stretching was matched to aerobic training with respect to location, frequency, duration, and intervention length. The primary endpoint was aerobic training feasibility, which was a priori defined as the lost to follow-up (LTF) rate (<20%) and attendance (≥70%). Secondary endpoints were safety, objective outcomes (VO 2peak and functional capacity), and patient-reported outcomes (PROs; quality of life). One of the 33 patients (3%) receiving aerobic training was LTF, whereas the mean attendance rate was 63% ± 30%. The rates of permanent discontinuation and dose modification were 27% and 49%, respectively. Intention-to-treat analyses indicated improvements in PROs, which favored the attention control group (P values > .05). Per protocol analyses indicated that 14 of 33 patients (42%) receiving aerobic training had acceptable tolerability (relative dose intensity ≥ 70%), and this led to improvements in VO 2peak and functional capacity (P values < .05). Aerobic training at the dose and schedule tested is safe but not feasible for a significant proportion of patients with metastatic breast cancer. The acceptable feasibility and promising benefit for select patients warrant further evaluation in a dose-finding phase 1/2 study. Cancer 2018. © 2018 American Cancer Society. © 2018 American Cancer Society.

7 CFR 4279.150 - Feasibility studies.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 7 Agriculture 15 2011-01-01 2011-01-01 false Feasibility studies. 4279.150 Section 4279.150... § 4279.150 Feasibility studies. A feasibility study by a qualified independent consultant may be required... affect the borrower's operations. An acceptable feasibility study should include, but not be limited to...

7 CFR 4279.150 - Feasibility studies.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 7 Agriculture 15 2010-01-01 2010-01-01 false Feasibility studies. 4279.150 Section 4279.150... § 4279.150 Feasibility studies. A feasibility study by a qualified independent consultant may be required... affect the borrower's operations. An acceptable feasibility study should include, but not be limited to...

CONTRACT Study - CONservative TReatment of Appendicitis in Children (feasibility): study protocol for a randomised controlled Trial.

PubMed

Hutchings, Natalie; Wood, Wendy; Reading, Isabel; Walker, Erin; Blazeby, Jane M; Van't Hoff, William; Young, Bridget; Crawley, Esther M; Eaton, Simon; Chorozoglou, Maria; Sherratt, Frances C; Beasant, Lucy; Corbett, Harriet; Stanton, Michael P; Grist, Simon; Dixon, Elizabeth; Hall, Nigel J

2018-03-02

pathways, clinical outcomes and safety of non-operative treatment. We have involved children, young people and parents in study design and delivery. In this study we will explore the feasibility of performing a full efficacy RCT comparing non-operative treatment with appendicectomy in children with acute uncomplicated appendicitis. Factors determining success of the present study include recruitment rate, safety of non-operative treatment and adequate interest in the future RCT. Ultimately this feasibility study will form the foundation of the main RCT and reinforce its design. ISRCTN15830435 . Registered on 8 February 2017.

UMCS feasibility study for Fort George G. Meade volume 1. Feasibility study

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

NONE

1996-12-01

Fort George G. Meade selected 83 buildings, from the approximately 1,500 buildings on the base to be included in the UMCS Feasibility Study. The purpose of the study is to evaluate the feasibility of replacing the existing analog based Energy Monitoring and Control System (EMCS) with a new distributed process Monitoring and Control System (UMCS).

Clinical safety of an MRI conditional implantable cardioverter defibrillator system: A prospective Monocenter ICD-Magnetic resonance Imaging feasibility study (MIMI).

PubMed

Kypta, Alexander; Blessberger, Hermann; Hoenig, Simon; Saleh, Karim; Lambert, Thomas; Kammler, Juergen; Fellner, Franz; Lichtenauer, Michael; Steinwender, Clemens

2016-03-01

The aim of this study was to evaluate the safety and efficacy of the Lumax 740(®) Implantable Cardioverter Defibrillator (ICD) system in patients undergoing a defined 1.5 Tesla (T) MRI. Between November 2013 and April 2014, eighteen patients (age range, 41-78 years; mean age, 64 years) implanted with a Lumax 740(®) ICD system for at least 6 weeks before an MRI were enrolled into this single-center feasibility study. The local ethics committee approved the study before patients gave written informed consent. Patients underwent defined MRI 1.5T of the brain and lower lumbar spine with three safety follow-up evaluations obtained during the 3-month study period. Data were analyzed descriptively. Study endpoints were the absence of either MRI and pacing system related serious adverse device effects (SADE), or of a ventricular pacing threshold increase >0.5V, or of an R-wave amplitude attenuation < 50%, or of an R-wave amplitude < 5.0 mV at 1-month follow-up. The assessment of safety and efficacy was supported by recording of all adverse events, changes in pacing threshold, R-wave sensing, pacing impedances and in battery status. Sixteen patients completed the MRI and the follow-up period. As no SADE occurred, the SADE free rate was 100%. Freedom from ventricular pacing threshold increase was 100% (16/16; 95%CI: 82.9%; 100.0%). There were no significant differences between baseline and follow-up measurements of sensing amplitudes (-0.58 ± 2.07 mV, P = 0.239, -0.41 ± 1.04 mV, P = 0.133, and -0.25 ± 1.36 mV, P = 0.724, for immediately after, 1 month and 3 months after MRI scan, respectively) and pacing thresholds (-0.047 ± 0.18 V, P = 0.317, -0.019 ± 0.11 V, P = 0.490, and 0.075 ± 0.19 V, P = 0.070, for immediately after, 1 month and 3 months after MRI scan, respectively). Lead impedances after the MRI scan were significantly lower as compared with baseline values (-22.8 ± 21.69 Ω, P = 0

Study of a safety margin system for powered-lift STOL aircraft

NASA Technical Reports Server (NTRS)

Heffley, R. K.; Jewell, W. F.

1978-01-01

A study was conducted to explore the feasibility of a safety margin system for powered-lift aircraft which require a backside piloting technique. The objective of the safety margin system was to present multiple safety margin criteria as a single variable which could be tracked manually or automatically and which could be monitored for the purpose of deriving safety margin status. The study involved a pilot-in-the-loop analysis of several safety margin system concepts and a simulation experiment to evaluate those concepts which showed promise of providing a good solution. A system was ultimately configured which offered reasonable compromises in controllability, status information content, and the ability to regulate the safety margin at some expense of the allowable low speed flight path envelope.

Pure retroperitoneal natural orifice translumenal endoscopic surgery (NOTES) transvaginal nephrectomy using standard laparoscopic instruments: a safety and feasibility study in a porcine model.

PubMed

Wei, Dechao; Han, Yili; Li, Mingchuan; Wang, Yongxing; Chen, Yatong; Luo, Yong; Jiang, Yongguang

2016-06-11

Among the different organs used for NOTES (natural orifice translumenal endoscopic surgery) technique, the transvaginal approach may be the optimal choice because of a simple and secure closure of colpotomy site. Pure and hybrid NOTES transvaginal operations were routinely performed via transperitoneal access. In this study, we investigate the safety and feasibility of pure retroperitoneal natural orifice translumenal endoscopic surgery (NOTES) transvaginal nephrectomy using conventional laparoscopic techniques in a porcine model. Six female pigs, weighing an average of 30 kg, were used in this study. Under general anesthesia, pure retroperitoneal NOTES transvaginal nephrectomy was conducted using standard laparoscopic instruments. Posterolateral colpotomy was performed, and the incision was enlarged laterally using blunt dissection and pneumatic dilation. A single-port device was inserted to construct the operative channel. The retroperitoneal space was created using sharp and blunt dissection under endoscopic guidance up to the level of the kidney. Dissection and removal of the kidney were performed according to standard surgical procedure, and the colpotomy site was closed using interrupted sutures. The survival and complications were observed 1 week postoperatively. Our results showed that two cases failed because of peritoneal rupture. One case was successful, but required the assistance of an extra 5 mm laparoscopic trocar inserted in the flank. Three cases of pure retroperitoneal NOTES transvaginal nephrectomy were completed, and survived 1 week after the operation. In these three cases, no intra- or postoperative complications were observed. All findings confirmed the safety and feasibility of the retroperitoneal pure retroperitoneal NOTES transvaginal nephrectomy using standard laparoscopic instruments, which suggested the possibility of clinical application in human beings in the future.

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.

Use of an Anti-Gravity Treadmill for Early Postoperative Rehabilitation After Total Knee Replacement: A Pilot Study to Determine Safety and Feasibility.

PubMed

Bugbee, William D; Pulido, Pamela A; Goldberg, Timothy; D'Lima, Darryl D

2016-01-01

The objective was to determine the safety, feasibility, and effects of anti-gravity gait training on functional outcomes (Knee Injury and Osteoarthritis Outcome Score [KOOS], the Timed Up and Go test [TUG], Numerical Rating Scale [NRS] for pain) with the AlterG® Anti-Gravity Treadmill® device for total knee arthroplasty (TKA) rehabilitation. Subjects (N = 30) were randomized to land-based vs anti-gravity gait training over 4 weeks of physical therapy after TKA. Adverse events, complications, and therapist satisfaction were recorded. All patients completed rehabilitation protocols without adverse events. KOOS, TUG, and NRS scores improved in both groups with no significant differences between groups. For the AlterG group, Sports/Recreation and Quality of Life subscales of the KOOS had the most improvement. At the end of physical therapy, TUG and NRS pain scores improved from 14 seconds to 8 seconds and from 2.8 to 1.1, respectively. Subjectively, therapists reported 100% satisfaction with the AlterG. This initial pilot study demonstrated that the AlterG Anti-Gravity Treadmill device was safe and feasible. While functional outcomes improved over time with use of the anti-gravity gait training, further studies are needed to define the role of this device as an alternative or adjunct to established rehabilitation protocols.

Is Home-Based, High-Intensity Interval Training Cycling Feasible and Safe for Patients With Knee Osteoarthritis?: Study Protocol for a Randomized Pilot Study.

PubMed

Keogh, Justin W L; Grigg, Josephine; Vertullo, Christopher J

2017-03-01

Osteoarthritis (OA) is a degenerative joint disease affecting the knee joint of many middle-aged and older adults. As OA symptoms typically involve knee pain and stiffness, individuals with knee OA are often insufficiently physically active, have low levels of physical function, and are at increased risk of other comorbidities and reduced quality of life. While moderate-intensity continuous training (MICT) cycling is often recommended, little is known about the feasibility, safety, and benefits of high-intensity interval training (HIIT) cycling for this population, even though the feasibility, safety, and benefits of HIIT have been demonstrated in other chronic disease groups. The primary objective of this pilot study was to examine the feasibility and safety of home-based HIIT and MICT cycling in middle-aged and older adults with knee OA. A secondary objective was to gain some insight into the relative efficacy of HIIT and MICT for improving health status (pain, stiffness, and disability), muscle function, and body composition in this population. This study protocol is being published separately to allow a detailed description of the research methods, explain the rationale for choosing the methodological details, and to stimulate consideration of the best means to simulate a research protocol that is relevant to a real-life treatment environment. Randomized pilot study protocol. This trial sought to recruit 40 middle-aged and older adults with knee OA. Participants were randomly allocated to either continuous (MICT) or HIIT home-based cycle training programs, with both programs requiring the performance of 4 cycling sessions (approximately 25 minutes per session) each week. Participants were measured at baseline and postintervention (8 weeks). Feasibility and safety were assessed by adherence rate, dropout rate, and number of adverse events. The relative efficacy of the cycling programs was investigated by 2 knee OA health status questionnaires (Western Ontario

Use of Active-Play Video Games to Enhance Aerobic Fitness in Schizophrenia: Feasibility, Safety, and Adherence.

PubMed

Kimhy, David; Khan, Samira; Ayanrouh, Lindsey; Chang, Rachel W; Hansen, Marie C; Lister, Amanda; Ballon, Jacob S; Vakhrusheva, Julia; Armstrong, Hilary F; Bartels, Matthew N; Sloan, Richard P

2016-02-01

Active-play video games have been used to enhance aerobic fitness in various clinical populations, but their use among individuals with schizophrenia has been limited. Feasibility, acceptability, safety, and adherence data were obtained for use of aerobic exercise (AE) equipment by 16 individuals with schizophrenia during a 12-week AE program consisting of three one-hour exercise sessions per week. Equipment included exercise video games for Xbox 360 with Kinect motion sensing devices and traditional exercise equipment. Most participants (81%) completed the training, attending an average of 79% of sessions. The proportion of time spent playing Xbox (39%) exceeded time spent on any other type of equipment. When using Xbox, participants played 2.24±1.59 games per session and reported high acceptability and enjoyment ratings, with no adverse events. Measures of feasibility, acceptability, adherence, and safety support the integration of active-play video games into AE training for people with schizophrenia.

Safety and feasibility of inpatient exercise training in pediatric heart failure: a preliminary report.

PubMed

McBride, Michael G; Binder, Tracy Jo; Paridon, Stephen M

2007-01-01

To determine the safety and feasibility of an inpatient exercise training program for a group of pediatric heart transplantation candidates on multiple inotropic support. Children with end-stage heart disease often require heart transplantation. Currently, no data exist on the safety and feasibility of an inpatient exercise training program in pediatric patients awaiting heart transplantation while on inotropic support. Twenty ambulatory patients (11 male; age, 13.6 +/- 3.2 years) were admitted, listed, and subsequently enrolled into an exercise training program while awaiting heart transplantation. Patient diagnoses consisted of dilated cardiomyopathy (n = 15), restrictive cardiomyopathy (n = 1), and failing single-ventricle physiology (n = 4). Inotropic support consisted of a combination of dobutamine, dopamine, or milrinone. Exercise sessions were scheduled three times a week lasting from 30 to 60 minutes and consisted of aerobic and musculoskeletal conditioning. Over 6.2 +/- 4.2 months, 1,251 of a possible 1,508 exercise training sessions were conducted, with a total of 615 hours (26.3 +/- 2.7 min/session) dedicated to low-intensity aerobic exercise. Reasons for noncompliance included a change in medical status, staffing, or patient cooperation. Two adverse episodes (seizures) occurred, neither of which resulted in termination from the program. No adverse episodes of hypotension or significant complex arrhythmias occurred. No complication of medication administration or loss of intravenous access occurred. Data from this study indicate that pediatric patients on inotropic support as a result of systemic ventricular or biventricular heart failure can safely participate in exercise training programs with relatively moderate to high compliance.

First-in-Human Ultrasound Molecular Imaging With a VEGFR2-Specific Ultrasound Molecular Contrast Agent (BR55) in Prostate Cancer: A Safety and Feasibility Pilot Study.

PubMed

Smeenge, Martijn; Tranquart, François; Mannaerts, Christophe K; de Reijke, Theo M; van de Vijver, Marc J; Laguna, M Pilar; Pochon, Sibylle; de la Rosette, Jean J M C H; Wijkstra, Hessel

2017-07-01

BR55, a vascular endothelial growth factor receptor 2 (VEGFR2)-specific ultrasound molecular contrast agent (MCA), has shown promising results in multiple preclinical models regarding cancer imaging. In this first-in-human, phase 0, exploratory study, we investigated the feasibility and safety of the MCA for the detection of prostate cancer (PCa) in men using clinical standard technology. Imaging with the MCA was performed in 24 patients with biopsy-proven PCa scheduled for radical prostatectomy using a clinical ultrasound scanner at low acoustic power. Safety monitoring was done by physical examination, blood pressure and heart rate measurements, electrocardiogram, and blood sampling. As first-in-human study, MCA dosing and imaging protocol were necessarily fine-tuned along the enrollment to improve visualization. Imaging data were correlated with radical prostatectomy histopathology to analyze the detection rate of ultrasound molecular imaging with the MCA. Imaging with MCA doses of 0.03 and 0.05 mL/kg was adequate to obtain contrast enhancement images up to 30 minutes after administration. No serious adverse events or clinically meaningful changes in safety monitoring data were identified during or after administration. BR55 dosing and imaging were fine-tuned in the first 12 patients leading to 12 subsequent patients with an improved MCA dosing and imaging protocol. Twenty-three patients underwent radical prostatectomy. A total of 52 lesions were determined to be malignant by histopathology with 26 (50%) of them seen during BR55 imaging. In the 11 patients that were scanned with the improved protocol and underwent radical prostatectomy, a total of 28 malignant lesions were determined: 19 (68%) were seen during BR55 ultrasound molecular imaging, whereas 9 (32%) were not identified. Ultrasound molecular imaging with BR55 is feasible with clinical standard technology and demonstrated a good safety profile. Detectable levels of the MCA can be reached in patients

MRI-guided Focused Ultrasound Ablation of Lumbar Medial Branch Nerve: Feasibility and Safety Study in a Swine Model

PubMed Central

Kaye, Elena A; Monette, Sebastien; Srimathveeravalli, Govindarajan; Maybody, Majid; Solomon, Stephen B; Gulati, Amitabh

2016-01-01

Purpose About 10–40% of chronic low back pain cases involve facet joints, which are commonly treated with lumbar medial branch (MB) radiofrequency neurotomy. Magnetic Resonance Imaging-guided Focused Ultrasound (MRgFUS), a non-invasive, non-ionizing ablation modality used to treat tumors, neuropathic pain and painful bone metastasis, can also be used to disrupt nerve conduction. This work’s purpose was to study the feasibility and safety of direct MRgFUS ablation of the lumbar MB nerve in acute and subacute swine models. Materials and Methods In vivo MRgFUS ablation was performed in six swine (3 acute and 3 subacute) using a clinical MRgFUS system (ExAblate 2000®; InSightec Ltd., Haifa, Israel) and 3 T MRI scanner (SIGNA; GE Healthcare, Waukesha, WI, USA) combination. Behavioral assessment was performed, and imaging and histology were used to assess the treatment. Results and Conclusions Histological analysis of the in vivo studies confirmed thermal necrosis of the MB nerve could be achieved without damaging the spinal cord or adjacent nerve roots. MRgFUS did not cause changes in the animals’ behavior and ambulation. PMID:27443328

Feasibility study from a randomized controlled trial of standard closure of a stoma site vs biological mesh reinforcement.

PubMed

2016-09-01

Hernia formation occurs at closed stoma sites in up to 30% of patients. The Reinforcement of Closure of Stoma Site (ROCSS) randomized controlled trial is evaluating whether placement of biological mesh during stoma closure safely reduces hernia rates compared with closure without mesh, without increasing surgical or wound complications. This paper aims to report recruitment, deliverability and safety from the internal feasibility study. A multicentre, patient and assessor blinded, randomized controlled trial, delivered through surgical trainee research networks. A 90-patient internal feasibility study assessed recruitment, randomization, deliverability and early (30 day) safety of the novel surgical technique (ClinicalTrials.gov registration number NCT02238964). The feasibility study recruited 90 patients from the 104 considered for entry (45 to mesh, 45 to no mesh). Seven of eight participating centres randomized patients within 30 days of opening. Overall, 41% of stomas were created for malignant disease and 73% were ileostomies. No mesh-specific complications occurred. Thirty-one postoperative adverse events were experienced by 31 patients, including surgical site infection (9%) and postoperative ileus (6%). One mesh was removed for re-access to the abdominal cavity, for reasons unrelated to the mesh. Independent review by the Data Monitoring and Ethics Committee of adverse event data by treatment allocation found no safety concerns. Multicentre randomization to this trial of biological mesh is feasible, with no early safety concerns. Progression to the full Phase III trial has continued. ROCSS shows that trainee research networks can efficiently develop and deliver complex interventional surgical trials. Colorectal Disease © 2016 The Association of Coloproctology of Great Britain and Ireland.

Feasibility, Safety, and Preliminary Effectiveness of a Home-Based Self-Managed High-Intensity Interval Training Program Offered to Long-Term Manual Wheelchair Users.

PubMed

Gauthier, Cindy; Brosseau, Rachel; Hicks, Audrey L; Gagnon, Dany H

2018-01-01

To investigate and compare the feasibility, safety, and preliminary effectiveness of home-based self-managed manual wheelchair high-intensity interval training (HIIT) and moderate-intensity continuous training (MICT) programs. Eleven manual wheelchair users were randomly assigned to the HIIT ( n = 6) or the MICT group ( n = 5). Both six-week programs consisted of three 40-minute propulsion training sessions per week. The HIIT group alternated between 30 s high-intensity intervals and 60 s low-intensity intervals, whereas the MICT group maintained a constant moderate intensity. Cardiorespiratory fitness, upper limb strength, and shoulder pain were measured before and after the programs. Participants completed a questionnaire on the programs that explored general areas of feasibility. The answers to the questionnaire demonstrated that both training programs were feasible in the community. No severe adverse events occurred, although some participants experienced increased shoulder pain during HIIT. Neither program yielded a significant change in cardiorespiratory fitness or upper limb strength. However, both groups reported moderate to significant subjective improvement. Home-based wheelchair HIIT appears feasible and safe although potential development of shoulder pain remains a concern and should be addressed with a future preventive shoulder exercise program. Some recommendations have been proposed for a larger study aiming to strengthen evidence regarding the feasibility, safety, and effectiveness of HIIT.

Patient Reporting of Safety experiences in Organisational Care Transfers (PRoSOCT): a feasibility study of a patient reporting tool as a proactive approach to identifying latent conditions within healthcare systems

PubMed Central

Scott, Jason; Waring, Justin; Heavey, Emily; Dawson, Pamela

2014-01-01

Background It is increasingly recognised that patients can play a role in reporting safety incidents. Studies have tended to focus on patients within hospital settings, and on the reporting of patient safety incidents as defined within a medical model of safety. This study aims to determine the feasibility of collecting and using patient experiences of safety as a proactive approach to identifying latent conditions of safety as patients undergo organisational care transfers. Methods and analysis The study comprises three components: (1) patients’ experiences of safety relating to a care transfer, (2) patients’ receptiveness to reporting experiences of safety, (3) quality improvement using patient experiences of safety. (1) A safety survey and evaluation form will be distributed to patients discharged from 15 wards across four clinical areas (cardiac, care of older people, orthopaedics and stroke) over 1 year. Healthcare professionals involved in the care transfer will be provided with a regular summary of patient feedback. (2) Patients (n=36) who return an evaluation form will be sampled representatively based on the four clinical areas and interviewed about their experiences of healthcare and safety and completing the survey. (3) Healthcare professionals (n=75) will be invited to participate in semistructured interviews and focus groups to discuss their experiences with and perceptions of receiving and using patient feedback. Data analysis will explore the relationship between patient experiences of safety and other indicators and measures of quality and safety. Interview and focus group data will be thematically analysed and triangulated with all other data sources using a convergence coding matrix. Ethics and dissemination The study has been granted National Health Service (NHS) Research Ethics Committee approval. Patient experiences of safety will be disseminated to healthcare teams for the purpose of organisational development and quality improvement

A systematic review and meta-analysis of the safety, feasibility and effect of exercise in women with stage II+ breast cancer.

PubMed

Singh, Ben; Spence, Rosalind R; Steele, Megan L; Sandler, Carolina X; Peake, Jonathan M; Hayes, Sandra C

2018-05-03

To systematically evaluate the safety, feasibility and effect of exercise among women with stage II+ breast cancer. CINAHL, Cochrane, Ebscohost, MEDLINE, Pubmed, ProQuest Health and Medical Complete, ProQuest Nursing and Allied Health Source, Science Direct and SPORTDiscus were searched for articles published prior to March 1, 2017. Randomised, controlled, exercise trials involving at least 50% of women diagnosed with stage II+ breast cancer were included. Risk of bias was assessed and adverse event severity was classified using the Common Terminology Criteria. Feasibility was evaluated by computing median (range) recruitment, withdrawal and adherence rates. Meta-analyses were performed to evaluate exercise safety and effects on health outcomes only. The influence of intervention characteristics (mode, supervision, duration and timing) on exercise outcomes were also explored. There were no differences in adverse events between exercise and usual care (risk difference: <0.01 [95% CI: -0.01, 0.01]), p=0.38). Median recruitment rate was 56% (1%-96%), withdrawal rate was 10% (0%-41%) and adherence rate was 82% (44%-99%). Safety and feasibility outcomes were similar, irrespective of exercise mode, supervision, duration, or timing. Effects of exercise for quality of life, fitness, fatigue, strength, anxiety, depression, body mass index and waist circumference compared with usual care were significant (standardised mean difference range: 0.17-0.77, p<0.05). The findings support the safety, feasibility and effects of exercise for those with stage II+ breast cancer, suggesting that national and international exercise guidelines appear generalizable to women with local, regional and distant breast cancer. Copyright © 2018. Published by Elsevier Inc.

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.

Safety and Feasibility of Transradial Access for Visceral Interventions in Patients with Thrombocytopenia.

PubMed

Titano, J J; Biederman, D M; Marinelli, B S; Patel, R S; Kim, E; Tabori, N E; Nowakowski, F S; Lookstein, R A; Fischman, A M

2016-05-01

Transradial access (TRA) has shown lower morbidity and decreased bleeding complications compared to transfemoral access. This study evaluates the safety and feasibility of TRA in thrombocytopenic patients undergoing visceral interventions. Patients who underwent visceral interventions via the radial artery with platelet count less than or equal to 50,000/µL were included in the study. Outcome variables included technical success, access site, bleeding, transfusion, and neurological complications. From July 1, 2012, to May 31, 2015, a total of 1353 peripheral interventions via TRA were performed, of which 85 procedures were performed in 64 patients (mean age 62.2 years) with a platelet count <50,000/µL (median 39,000/µL). Interventions included chemoembolization (n = 46), selective internal radiation therapy (n = 30), and visceral embolization (n = 9). Technical success was 97.6% with two cases of severe vessel spasm requiring ipsilateral femoral crossover. There was no major access site, bleeding, or neurological adverse events at 30 days. Minor access site hematomas occurred in five cases (5.9%) and were treated conservatively in all cases. Pre-procedural platelet transfusions were administered in 23 (27.1%) cases. There was no statistically significant difference in access site or bleeding complications between the transfused and nontransfused groups. Transradial visceral interventions in patients with thrombocytopenia are both feasible and safe, possibly without the need for platelet transfusions.

Visually guided male urinary catheterization: a feasibility study.

PubMed

Willette, Paul A; Banks, Kevin; Shaffer, Lynn

2013-01-01

Ten percent to 15% of urinary catheterizations involve complications. New techniques to reduce risks and pain are indicated. This study examines the feasibility and safety of male urinary catheterization by nursing personnel using a visually guided device in a clinical setting. The device, a 0.6-mm fiber-optic bundle inside a 14F triple-lumen flexible urinary catheter with a lubricious coating, irrigation port, and angled tip, connects to a camera, allowing real-time viewing of progress on a color monitor. Two emergency nurses were trained to use the device. Male patients 18 years or older presenting to the emergency department with an indication for urinary catheterization using a standard Foley or Coudé catheter were eligible to participate in the study. Exclusion criteria were a current suprapubic tube or gross hematuria prior to the procedure. Twenty-five patients were enrolled. Data collected included success of placement, total procedure time, pre-procedure pain and maximum pain during the procedure, gross hematuria, abnormalities or injuries identified if catheterization failed, occurrence of and reason for equipment failures, and number of passes required for placement. All catheters were successfully placed. The median number of passes required was 1. For all but one patient, procedure time was ≤ 17 minutes. A median increase in pain scores of 1 point from baseline to the maximum was reported. Gross hematuria was observed in 2 patients. The success rate for placement of a Foley catheter with the visually guided device was 100%, indicating its safety, accuracy, and feasibility in a clinical setting. Minimal pain was associated with the procedure. Copyright © 2013 Emergency Nurses Association. Published by Mosby, Inc. All rights reserved.

Safety, Feasibility, and Efficacy of Vagus Nerve Stimulation Paired With Upper-Limb Rehabilitation After Ischemic Stroke.

PubMed

Dawson, Jesse; Pierce, David; Dixit, Anand; Kimberley, Teresa J; Robertson, Michele; Tarver, Brent; Hilmi, Omar; McLean, John; Forbes, Kirsten; Kilgard, Michael P; Rennaker, Robert L; Cramer, Steven C; Walters, Matthew; Engineer, Navzer

2016-01-01

Recent animal studies demonstrate that vagus nerve stimulation (VNS) paired with movement induces movement-specific plasticity in motor cortex and improves forelimb function after stroke. We conducted a randomized controlled clinical pilot study of VNS paired with rehabilitation on upper-limb function after ischemic stroke. Twenty-one participants with ischemic stroke >6 months before and moderate to severe upper-limb impairment were randomized to VNS plus rehabilitation or rehabilitation alone. Rehabilitation consisted of three 2-hour sessions per week for 6 weeks, each involving >400 movement trials. In the VNS group, movements were paired with 0.5-second VNS. The primary objective was to assess safety and feasibility. Secondary end points included change in upper-limb measures (including the Fugl-Meyer Assessment-Upper Extremity). Nine participants were randomized to VNS plus rehabilitation and 11 to rehabilitation alone. There were no serious adverse device effects. One patient had transient vocal cord palsy and dysphagia after implantation. Five had minor adverse device effects including nausea and taste disturbance on the evening of therapy. In the intention-to-treat analysis, the change in Fugl-Meyer Assessment-Upper Extremity scores was not significantly different (between-group difference, 5.7 points; 95% confidence interval, -0.4 to 11.8). In the per-protocol analysis, there was a significant difference in change in Fugl-Meyer Assessment-Upper Extremity score (between-group difference, 6.5 points; 95% confidence interval, 0.4 to 12.6). This study suggests that VNS paired with rehabilitation is feasible and has not raised safety concerns. Additional studies of VNS in adults with chronic stroke will now be performed. URL: https://www.clinicaltrials.gov. Unique identifier: NCT01669161. © 2015 The Authors.

TIA triage in emergency department using acute MRI (TIA-TEAM): a feasibility and safety study.

PubMed

Vora, Nirali; Tung, Christie E; Mlynash, Michael; Garcia, Madelleine; Kemp, Stephanie; Kleinman, Jonathan; Zaharchuk, Greg; Albers, Gregory; Olivot, Jean-Marc

2015-04-01

Positive diffusion weighted imaging (DWI) on MRI is associated with increased recurrent stroke risk in TIA patients. Acute MRI aids in TIA risk stratification and diagnosis. To evaluate the feasibility and safety of TIA triage directly from the emergency department (ED) with acute MRI and neurological consultation. Consecutive ED TIA patients assessed by a neurologist underwent acute MRI/MRA of head/neck per protocol and were hospitalized if positive DWI, symptomatic vessel stenosis, or per clinical judgment. Stroke neurologist adjudicated the final TIA diagnosis as definite, possible, or not a cerebrovascular event. Stroke recurrence rates were calculated at 7, 90, 365 days and compared with predicted stroke rates derived from historical DWI and ABCD(2) score data. One hundred twenty-nine enrolled patients had a mean age of 69 years (± 17) and median ABCD(2) score of 3 (interquartile range [IQR] 3-4). During triage, 112 (87%) patients underwent acute MRI after a median of 16 h (IQR 10-23) from symptom onset. No patients experienced a recurrent event before imaging. Twenty-four (21%) had positive DWI and 8 (7%) had symptomatic vessel stenosis. Of the total cohort, 83 (64%) were discharged and 46 (36%) were hospitalized. By one-year follow-up, one patient in each group had experienced a stroke. Of 92 patients with MRI and index cerebrovascular event, recurrent stroke rates were 1.1% at 7 and 90 days. These were similar to predicted recurrence rates. TIA triage in the ED using a protocol with neurological consultation and acute MRI is feasible and safe. The majority of patients were discharged without hospitalization and rates of recurrent stroke were not higher than predicted. © 2014 World Stroke Organization.

25 CFR 41.7 - Feasibility studies.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 25 Indians 1 2010-04-01 2010-04-01 false Feasibility studies. 41.7 Section 41.7 Indians BUREAU OF... NAVAJO COMMUNITY COLLEGE Tribally Controlled Community Colleges § 41.7 Feasibility studies. (a) Grants... initiate a feasibility study to determine whether there is justification to encourage and maintain a...

25 CFR 41.7 - Feasibility studies.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 25 Indians 1 2011-04-01 2011-04-01 false Feasibility studies. 41.7 Section 41.7 Indians BUREAU OF... NAVAJO COMMUNITY COLLEGE Tribally Controlled Community Colleges § 41.7 Feasibility studies. (a) Grants... initiate a feasibility study to determine whether there is justification to encourage and maintain a...

Safety and Feasibility of the 6-Minute Walk Test in Patients with Acute Stroke.

PubMed

Kubo, Hiroki; Nozoe, Masafumi; Yamamoto, Miho; Kamo, Arisa; Noguchi, Madoka; Kanai, Masashi; Mase, Kyoshi; Shimada, Shinichi

2018-06-01

Our objective was to investigate the safety and feasibility of the 6-minute walk test in patients with acute stroke. Consecutive patients with acute stroke, admitted to the Itami Kosei Neurosurgical Hospital from September 2016 to April 2017 were enrolled. Walking capacity was assessed by a physical therapist using the 6-minute walk test in 94 patients with acute stroke within 14 days of hospital admission. The primary outcomes were safety (i.e., the prevalence of new adverse events during and after the test) and feasibility (i.e., test completion rate) of the 6-minute walk test. The 6-minute walk test was performed for a mean duration of 5.1 days (standard deviation, 2.6 days) after hospital admission. Seventy patients (74.5%) could walk without standby assistance or a walking aid, and 24 patients (25.5%) could walk without standby assistance but with a walking aid. The average distance walked by patients during the 6-minute walk test was 331 m (standard deviation, 107.2 m). Adverse events following the 6-minute walk test occurred in 6 patients (6.4%) and included stroke progression, stroke recurrence, seizures, and neurological deterioration. Heart rate increase (>120 beats/min) occurred in 3 patients (3.2%) during the test. Lastly, 6 patients (6.4%) were unable to complete the 6-minute walk test. Although performance in the 6-minute walk test was decreased in patients with acute stroke, the test itself appears to be safe and feasible in this patient population. Copyright © 2018 National Stroke Association. Published by Elsevier Inc. All rights reserved.

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.

Safety, Feasibility, and Efficacy of Vagus Nerve Stimulation Paired With Upper-Limb Rehabilitation After Ischemic Stroke

PubMed Central

Pierce, David; Dixit, Anand; Kimberley, Teresa J.; Robertson, Michele; Tarver, Brent; Hilmi, Omar; McLean, John; Forbes, Kirsten; Kilgard, Michael P.; Rennaker, Robert L.; Cramer, Steven C.; Walters, Matthew; Engineer, Navzer

2016-01-01

Background and Purpose— Recent animal studies demonstrate that vagus nerve stimulation (VNS) paired with movement induces movement-specific plasticity in motor cortex and improves forelimb function after stroke. We conducted a randomized controlled clinical pilot study of VNS paired with rehabilitation on upper-limb function after ischemic stroke. Methods— Twenty-one participants with ischemic stroke >6 months before and moderate to severe upper-limb impairment were randomized to VNS plus rehabilitation or rehabilitation alone. Rehabilitation consisted of three 2-hour sessions per week for 6 weeks, each involving >400 movement trials. In the VNS group, movements were paired with 0.5-second VNS. The primary objective was to assess safety and feasibility. Secondary end points included change in upper-limb measures (including the Fugl–Meyer Assessment-Upper Extremity). Results— Nine participants were randomized to VNS plus rehabilitation and 11 to rehabilitation alone. There were no serious adverse device effects. One patient had transient vocal cord palsy and dysphagia after implantation. Five had minor adverse device effects including nausea and taste disturbance on the evening of therapy. In the intention-to-treat analysis, the change in Fugl–Meyer Assessment-Upper Extremity scores was not significantly different (between-group difference, 5.7 points; 95% confidence interval, −0.4 to 11.8). In the per-protocol analysis, there was a significant difference in change in Fugl–Meyer Assessment-Upper Extremity score (between-group difference, 6.5 points; 95% confidence interval, 0.4 to 12.6). Conclusions— This study suggests that VNS paired with rehabilitation is feasible and has not raised safety concerns. Additional studies of VNS in adults with chronic stroke will now be performed. Clinical Trial Registration— URL: https://www.clinicaltrials.gov. Unique identifier: NCT01669161. PMID:26645257

Safety and Feasibility of Transradial Access for Visceral Interventions in Patients with Thrombocytopenia

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

Titano, J. J., E-mail: joseph.titano@mountsinai.org; Biederman, D. M., E-mail: derek.biederman@mountsinai.org; Marinelli, B. S., E-mail: brett.marinelli@exchange.mssm.edu

PurposeTransradial access (TRA) has shown lower morbidity and decreased bleeding complications compared to transfemoral access. This study evaluates the safety and feasibility of TRA in thrombocytopenic patients undergoing visceral interventions.Methods and MaterialsPatients who underwent visceral interventions via the radial artery with platelet count less than or equal to 50,000/µL were included in the study. Outcome variables included technical success, access site, bleeding, transfusion, and neurological complications.ResultsFrom July 1, 2012, to May 31, 2015, a total of 1353 peripheral interventions via TRA were performed, of which 85 procedures were performed in 64 patients (mean age 62.2 years) with a platelet count <50,000/µLmore » (median 39,000/µL). Interventions included chemoembolization (n = 46), selective internal radiation therapy (n = 30), and visceral embolization (n = 9). Technical success was 97.6 % with two cases of severe vessel spasm requiring ipsilateral femoral crossover. There was no major access site, bleeding, or neurological adverse events at 30 days. Minor access site hematomas occurred in five cases (5.9 %) and were treated conservatively in all cases. Pre-procedural platelet transfusions were administered in 23 (27.1 %) cases. There was no statistically significant difference in access site or bleeding complications between the transfused and nontransfused groups.ConclusionsTransradial visceral interventions in patients with thrombocytopenia are both feasible and safe, possibly without the need for platelet transfusions.« less

Local rhBMP-12 on an Absorbable Collagen Sponge as an Adjuvant Therapy for Rotator Cuff Repair - A Phase 1, Randomized, Standard of Care Control, Multicenter Study: Safety and Feasibility.

PubMed

Greiner, Stefan; Ide, Junji; Van Noort, Arthur; Mochizuki, Yu; Ochi, Hiroshi; Marraffino, Shannon; Sridharan, Sudhakar; Rudicel, Sally; Itoi, Eiji

2015-08-01

Recombinant human bone morphogenetic protein-12 (rhBMP-12) has been shown to induce tendon and ligament formation in rats and to improve tendon healing; however, the safety and feasibility of implanting rhBMP-12/absorbable collagen sponge (ACS) in humans are not known. To investigate the safety and feasibility of rhBMP-12 on an ACS as an adjuvant therapy in open rotator cuff repair. Randomized controlled trial; Level of evidence, 2. This study consisted of 20 patients with full-thickness rotator cuff tears. Patients were randomized either to standard of care (SOC) treatment (open rotator cuff repair) or to receive 0.015 mg/mL rhBMP-12/ACS and SOC treatment during their open rotator cuff repair (rhBMP-12/ACS group) at a rate of 1/4 SOC/rhBMP-12/ACS. The feasibility of implanting the product and the safety of the product were evaluated during the 1-year follow-up period. The evaluation involved up to 10 postoperative visits, which included physical examinations, radiographs, computed tomography (CT) scans, magnetic resonance imaging (MRI) scans with an emphasis on heterotopic ossification (HO), pharmacokinetics, immunogenicity, laboratory evaluations, and local and systemic adverse events at specified time points. Small amounts of HO were seen on follow-up CT scans in 10 of 16 patients in the rhBMP-12/ACS group and in 2 of 3 patients in the SOC group. HO did not increase at 26 weeks and was not associated with any adverse events or unsatisfactory clinical outcomes. Pharmacokinetics demonstrated that circulating levels of rhBMP-12 were not detectable after administration. Five of 16 patients showed a postoperative immunogenic response but did not show any correlating adverse events. Complete healing of the rotator cuff was observed in 14 of 16 patients; 2 of 16 imaging results could not be analyzed because of artifacts in the rhBMP-12 group on MRI scans. In the SOC group, 1 of 4 patients showed a retear at 12 weeks after surgery. The use of rhBMP-12/ACS has been shown

Rural jail telepsychiatry: a pilot feasibility study.

PubMed

Manfredi, Luisa; Shupe, Joann; Batki, Steven L

2005-10-01

New York State has a large rural population, and many of the jails in rural areas have minimal or no psychiatric services available on site. Cost of transport to off-site psychiatric services and the safety issues related to moving inmates from a secure building may limit inmate access to appropriate psychiatric services. This feasibility study describes a project that provided telepsychiatric consultation to increase access to psychiatric treatment in an underserved rural jail in upstate New York. Subjects were consenting jail inmates who requested or were found to be in need of psychiatric care. The project provided interactive two-way audio-video communication between the psychiatrist located in an urban university medical center and subjects who were incarcerated 182 miles away. During the project period, 15 inmates were assessed and treated in 37 consultations. Subjects were predominantly young white males with anxiety, mood, and substance use disorders. Services were readily accepted by inmates and staff. Telepsychiatric examination and treatment appears to be a feasible method to increase access to mental health care in rural jails. Future advocacy for increased mental health services in rural areas in criminal justice setting is likely to depend on further evidence of favorable cost benefit.

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.

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

Catheter-Based Measurements of Absolute Coronary Blood Flow and Microvascular Resistance: Feasibility, Safety, and Reproducibility in Humans.

PubMed

Xaplanteris, Panagiotis; Fournier, Stephane; Keulards, Daniëlle C J; Adjedj, Julien; Ciccarelli, Giovanni; Milkas, Anastasios; Pellicano, Mariano; Van't Veer, Marcel; Barbato, Emanuele; Pijls, Nico H J; De Bruyne, Bernard

2018-03-01

The principle of continuous thermodilution can be used to calculate absolute coronary blood flow and microvascular resistance (R). The aim of the study is to explore the safety, feasibility, and reproducibility of coronary blood flow and R measurements as measured by continuous thermodilution in humans. Absolute coronary flow and R can be calculated by thermodilution by infusing saline at room temperature through a dedicated monorail catheter. The temperature of saline as it enters the vessel, the temperature of blood and saline mixed in the distal part of the vessel, and the distal coronary pressure were measured by a pressure/temperature sensor-tipped guidewire. The feasibility and safety of the method were tested in 135 patients who were referred for coronary angiography. No significant adverse events were observed; in 11 (8.1%) patients, bradycardia and concomitant atrioventricular block appeared transiently and were reversed immediately on interruption of the infusion. The reproducibility of measurements was tested in a subgroup of 80 patients (129 arteries). Duplicate measurements had a strong correlation both for coronary blood flow (ρ=0.841, P <0.001; intraclass correlation coefficient=0.89, P <0.001) and R (ρ=0.780, P <0.001; intraclass correlation coefficient=0.89, P <0.001). In Bland-Altman plots, there was no significant bias or asymmetry. Absolute coronary blood flow (in L/min) and R (in mm Hg/L/min or Wood units) can be safely and reproducibly measured with continuous thermodilution. This approach constitutes a new opportunity for the study of the coronary microcirculation. © 2018 American Heart Association, Inc.

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

The patient reporting and action for a safe environment (PRASE) intervention: a feasibility study.

PubMed

O'Hara, Jane K; Lawton, Rebecca J; Armitage, Gerry; Sheard, Laura; Marsh, Claire; Cocks, Kim; McEachan, Rosie R C; Reynolds, Caroline; Watt, Ian; Wright, John

2016-11-28

There is growing interest in the role of patients in improving patient safety. One such role is providing feedback on the safety of their care. Here we describe the development and feasibility testing of an intervention that collects patient feedback on patient safety, brings together staff to consider this feedback and to plan improvement strategies. We address two research questions: i) to explore the feasibility of the process of systematically collecting feedback from patients about the safety of care as part of the PRASE intervention; and, ii) to explore the feasibility and acceptability of the PRASE intervention for staff, and to understand more about how staff use the patient feedback for service improvement. We conducted a feasibility study using a wait-list controlled design across six wards within an acute teaching hospital. Intervention wards were asked to participate in two cycles of the PRASE (Patient Reporting & Action for a Safe Environment) intervention across a six-month period. Participants were patients on participating wards. To explore the acceptability of the intervention for staff, observations of action planning meetings, interviews with a lead person for the intervention on each ward and recorded researcher reflections were analysed thematically and synthesised. Recruitment of patients using computer tablets at their bedside was straightforward, with the majority of patients willing and able to provide feedback. Randomisation of the intervention was acceptable to staff, with no evidence of differential response rates between intervention and control groups. In general, ward staff were positive about the use of patient feedback for service improvement and were able to use the feedback as a basis for action planning, although engagement with the process was variable. Gathering a multidisciplinary team together for action planning was found to be challenging, and implementing action plans was sometimes hindered by the need to co

An interventional approach for patient and nurse safety: a fatigue countermeasures feasibility study.

PubMed

Scott, Linda D; Hofmeister, Nancee; Rogness, Neal; Rogers, Ann E

2010-01-01

Studies indicate that extended shifts worked by hospital staff nurses are associated with higher risk of errors. Long work hours coupled with insufficient sleep and fatigue are even riskier. Although other industries have developed programs to reduce fatigue-related errors and injury, fatigue countermeasures program for nurses (FCMPN) are lacking. The objective of this study was to evaluate the feasibility of an FCMPN for improving sleep duration and quality while reducing daytime sleepiness and patient care errors. Selected sleep variables, errors and drowsy driving, were evaluated among hospital staff nurses (n = 47) before and after FCMPN implementation. A one-group pretest-posttest repeated-measures approach was used. Participants provided data 2 weeks before the FCMPN, 4 weeks after receiving the intervention, and again at 3 months after intervention. Most of the nurses experienced poor sleep quality, severe daytime sleepiness, and decreased alertness at work and while operating a motor vehicle. After the FCMPN, significant improvements were noted in sleep duration, sleep quality, alertness, and error prevention. Although significant improvements were not found in daytime sleepiness scores, severity of daytime sleepiness appeared to decrease. Despite improvements in fatigue management, nurses reported feelings of guilt when engaging in FCMPN activities, especially strategic naps and relieved breaks. Initial findings support the feasibility of using an FCMPN for mitigating fatigue, improving sleep, and reducing errors among hospital staff nurses. In future investigations, the acceptability, efficacy, and effectiveness of FCMPNs can be examined.

Safety and efficacy of prophylactic negative pressure wound therapy following open saphenous vein harvest in cardiac surgery: a feasibility study.

PubMed

Lee, Arthur J; Sheppard, Christina E; Kent, William D T; Mewhort, Holly; Sikdar, Khokan C; Fedak, Paul W M

2017-03-01

Surgical site complications following great saphenous vein (GSV) harvest presents a significant risk of morbidity. Negative pressure wound therapy (NPWT) has shown promise in the treatment and prophylaxis of open wounds and surgical incisions but has not been studied following GSV harvest. We performed a feasibility study examining the use of NPWT following GSV harvest for coronary bypass surgery. Sixty-four patients were recruited in this single-centre, single-blind, randomized controlled trial. The primary endpoint assessed feasibility by examining rates of device complication and malfunction. Secondary endpoints included rates of surgical site infection, lower leg complications, discharge date, and quality of life at discharge and 6 weeks. NPWT was delivered using the Prevena NPWT device. There were no complications associated with NPWT which required intervention aside from discontinuation. NPWT was tolerated in 91% (30/33) of patients for the duration of treatment with an average of 4.8 days (±1.45 days). Device malfunction which required discontinuation was 6% (2/33) and involved a malfunctioning pressure sensor and did not affect patient care or present safety concerns. One patient had allergic contact dermatitis to the adhesive and had the device removed. NPWT patients had an earlier date of discharge (6 vs 10 days, P = 0.008), increased ability for self-care ( P = 0.0234) and quality of life ( P = 0.039) at initial assessment, and increased mobility at initial and follow-up assessment ( P = 0.0117 and 0.0123). The use of NPWT following GSV harvest is safe, well tolerated and improves postoperative recovery with prolonged impact on mobility at 6 weeks. https://clinicaltrials.gov/ct2/show/NCT01698372 ; registration number: NCT01698372. © The Author 2016. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved.

Embolization with ethylene vinyl alcohol copolymer (Onyx®) for peripheral hemostatic and non-hemostatic applications: a feasibility and safety study

PubMed Central

Né, Romaric; Chevallier, Olivier; Falvo, Nicolas; Facy, Olivier; Berthod, Pierre-Emmanuel; Galland, Christophe; Gehin, Sophie; Midulla, Marco

2018-01-01

Background Onyx® is a liquid embolic agent, which is approved for the treatment of cerebral vascular lesions but still rarely used in peripheral interventional radiology. The goal of this study is to report the feasibility and safety of embolization with Onyx® for peripheral hemostatic and non-hemostatic endovascular procedures. Methods Retrospective study of all consecutive patients who underwent visceral or peripheral embolization with Onyx® for hemostatic or non-hemostatic purpose in our department between May 2014 and November 2016. Demographic data, clinical presentation, underlying etiology, culprit vessel, endovascular procedure, pain during embolization, outcomes, and follow-up data were collected. Results Fifty patients (males, 34; females, 16; mean age, 56±18 years; range, 15–89 years) were included. Twenty-nine (58%) of patients underwent hemostatic embolization for arterial (n=22, 44%) or venous (n=7, 14%) bleeding lesions, whereas 21 (42%) of patients underwent non-hemostatic embolization for arterial aneurysms (n=8, 16%), preoperative portal vein deprivation (n=6, 12%) or other indications (n=7, 14%). Onyx-18 was used in 37 (74%) patients, Onyx-34 in 9 (18%) patients, and a combination of both in 4 (8%) patients. Onyx was used alone in 25 (50%) patients and in combination with other agent in 25 (50%) patients. Mean number of Onyx® vials used was 3.7 (range, 1–17). Immediate technical success rate was 100%. Primary clinical success was achieved in all patients. Recurrent bleeding occurred in two patients. Significant pain (pain score ≥3) was noted during injection in 10 (20%) patients. No major complication or side effects were noted within 1 month. Conclusions Transcatheter embolization with Onyx® is feasible and safe in the peripheral arterial or venous vasculature for both bleeding and non-bleeding patients whatever the anatomic site. PMID:29774181

Embolization with ethylene vinyl alcohol copolymer (Onyx®) for peripheral hemostatic and non-hemostatic applications: a feasibility and safety study.

PubMed

Né, Romaric; Chevallier, Olivier; Falvo, Nicolas; Facy, Olivier; Berthod, Pierre-Emmanuel; Galland, Christophe; Gehin, Sophie; Midulla, Marco; Loffroy, Romaric

2018-04-01

Onyx ® is a liquid embolic agent, which is approved for the treatment of cerebral vascular lesions but still rarely used in peripheral interventional radiology. The goal of this study is to report the feasibility and safety of embolization with Onyx ® for peripheral hemostatic and non-hemostatic endovascular procedures. Retrospective study of all consecutive patients who underwent visceral or peripheral embolization with Onyx ® for hemostatic or non-hemostatic purpose in our department between May 2014 and November 2016. Demographic data, clinical presentation, underlying etiology, culprit vessel, endovascular procedure, pain during embolization, outcomes, and follow-up data were collected. Fifty patients (males, 34; females, 16; mean age, 56±18 years; range, 15-89 years) were included. Twenty-nine (58%) of patients underwent hemostatic embolization for arterial (n=22, 44%) or venous (n=7, 14%) bleeding lesions, whereas 21 (42%) of patients underwent non-hemostatic embolization for arterial aneurysms (n=8, 16%), preoperative portal vein deprivation (n=6, 12%) or other indications (n=7, 14%). Onyx-18 was used in 37 (74%) patients, Onyx-34 in 9 (18%) patients, and a combination of both in 4 (8%) patients. Onyx was used alone in 25 (50%) patients and in combination with other agent in 25 (50%) patients. Mean number of Onyx ® vials used was 3.7 (range, 1-17). Immediate technical success rate was 100%. Primary clinical success was achieved in all patients. Recurrent bleeding occurred in two patients. Significant pain (pain score ≥3) was noted during injection in 10 (20%) patients. No major complication or side effects were noted within 1 month. Transcatheter embolization with Onyx ® is feasible and safe in the peripheral arterial or venous vasculature for both bleeding and non-bleeding patients whatever the anatomic site.

Autonomous Aerobraking: A Design, Development, and Feasibility Study

NASA Technical Reports Server (NTRS)

Prince, Jill L. H.; Powell, Richard W.; Murri, Dan

2011-01-01

Aerobraking has been used four times to decrease the apoapsis of a spacecraft in a captured orbit around a planetary body with a significant atmosphere utilizing atmospheric drag to decelerate the spacecraft. While aerobraking requires minimum fuel, the long time required for aerobraking requires both a large operations staff, and large Deep Space Network resources. A study to automate aerobraking has been sponsored by the NASA Engineering and Safety Center to determine initial feasibility of equipping a spacecraft with the onboard capability for autonomous aerobraking, thus saving millions of dollars incurred by a large aerobraking operations workforce and continuous DSN coverage. This paper describes the need for autonomous aerobraking, the development of the Autonomous Aerobraking Development Software that includes an ephemeris estimator, an atmospheric density estimator, and maneuver calculation, and the plan forward for continuation of this study.

White Paper on studying the safety of the childhood immunization schedule in the Vaccine Safety Datalink.

PubMed

Glanz, Jason M; Newcomer, Sophia R; Jackson, Michael L; Omer, Saad B; Bednarczyk, Robert A; Shoup, Jo Ann; DeStefano, Frank; Daley, Matthew F

2016-02-15

While the large majority of parents in the U.S. vaccinate their children according to the recommended immunization schedule, some parents have refused or delayed vaccinating, often citing safety concerns. In response to public concern, the U.S. Institute of Medicine (IOM) evaluated existing research regarding the safety of the recommended immunization schedule. The IOM concluded that although available evidence strongly supported the safety of the currently recommended schedule as a whole, additional observational research was warranted to compare health outcomes between fully vaccinated children and those on a delayed or alternative schedule. In addition, the IOM identified the Vaccine Safety Datalink (VSD) as an important resource for conducting this research. Guided by the IOM findings, the Centers for Disease Control and Prevention (CDC) commissioned a White Paper to assess how the VSD could be used to study the safety of the childhood immunization schedule. Guided by subject matter expert engagement, the resulting White Paper outlines a 4 stage approach for identifying exposure groups of undervaccinated children, presents a list of health outcomes of highest priority to examine in this context, and describes various study designs and statistical methods that could be used to analyze the safety of the schedule. While it appears feasible to study the safety of the recommended immunization schedule in settings such as the VSD, these studies will be inherently complex, and as with all observational studies, will need to carefully address issues of confounding and bias. In light of these considerations, decisions about conducting studies of the safety of the schedule will also need to assess epidemiological evidence of potential adverse events that could be related to the schedule, the biological plausibility of an association between an adverse event and the schedule, and public concern about the safety of the schedule. Copyright © 2015 Elsevier Ltd. All rights

TScan : stationary LiDAR for traffic and safety studies : object detection and tracking.

DOT National Transportation Integrated Search

2016-08-01

The ability to accurately measure and cost-effectively collect traffic data at road intersections is needed to improve their safety and operations. This study investigates the feasibility of using laser ranging technology (LiDAR) for this purpose. Th...

Ecological Feasibility Studies in Restoration Decision Making

NASA Astrophysics Data System (ADS)

Hopfensperger, Kristine N.; Engelhardt, Katharina A. M.; Seagle, Steven W.

2007-06-01

The restoration of degraded systems is essential for maintaining the provision of valuable ecosystem services, including the maintenance of aesthetic values. However, restoration projects often fail to reach desired goals for a variety of ecologic, financial, and social reasons. Feasibility studies that evaluate whether a restoration effort should even be attempted can enhance restoration success by highlighting potential pitfalls and gaps in knowledge before the design phase of a restoration. Feasibility studies also can bring stakeholders together before a restoration project is designed to discuss potential disagreements. For these reasons, a feasibility study was conducted to evaluate the efficacy of restoring a tidal freshwater marsh in the Potomac River near Alexandria, Virginia. The study focused on science rather than engineering questions, and thus differed in approach from other feasibility studies that are mostly engineering driven. The authors report the framework they used to conduct a feasibility study to inform other potential restoration projects with similar goals. The seven steps of the framework encompass (1) initiation of a feasibility study, (2) compilation of existing data, (3) collection of current site information, (4) examination of case studies, (5) synthesis of information in a handbook, (6) meeting with selected stakeholders, and (7) evaluation of meeting outcomes. By conducting a feasibility study using the seven-step framework, the authors set the stage for conducting future compliance studies and enhancing the chance of a successful restoration.

"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.

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.

A Novel Self-Expandable, Radioactive Airway Stent Loaded with 125I Seeds: A Feasibility and Safety Study in Healthy Beagle Dog.

PubMed

Wang, Yong; Guo, Jin-He; Zhu, Guang-Yu; Zhu, Hai-Dong; Chen, Li; Lu, Jian; Wang, Chao; Teng, Gao-Jun

2017-07-01

Airway stent placement is an effective treatment for the immediate palliation of malignant airway obstruction. However, restenosis caused by tumor ingrowth and/or overgrowth after stenting is common. The purpose of this study was to investigate the feasibility and safety of a novel self-expandable stent loaded with 125 I seeds in healthy beagle dog. Under fluoroscopic guidance, forty-eight self-expandable airway stents loaded with 125 I seeds were perorally placed in the main trachea of 48 healthy beagle dogs, who were randomly divided into four groups (Group A: 0.3 mCi; Group B: 0.6 mCi; Group C: 0.9 mCi; Control group: 0 mCi). The estimated radiation dose was calculated using the isotropic point source approximation. Radiological follow-up examinations and histopathological examinations of stented tracheal segments and their adjacent organs and tissues were performed at 2, 4, 8, and 16 weeks following the stenting. All stents were successfully deployed in the targeted tracheal segment in the beagle dogs without procedure-related complications. Tracheal stenosis became severe gradually in all the four groups, which was not associated with the radioactivity of 125 I seeds (p > 0.05). The tracheal injury scores increased along with the higher dose of radioactive seeds which reached peak at 8 weeks and then turned back slightly at 16 weeks. The adjacent tissue did not show pathohistological changes under microscope, while mild and reversible ultrastructure changes were showed under electronic microscope. This study demonstrates that it is feasible and safe to insert this novel self-expandable airway stent loaded with 125 I seeds in healthy beagle dog.

7 CFR 1737.70 - Description of feasibility study

Code of Federal Regulations, 2011 CFR

2011-01-01

... 7 Agriculture 11 2011-01-01 2011-01-01 false Description of feasibility study 1737.70 Section 1737... TELECOMMUNICATIONS LOANS Feasibility Determination Procedures § 1737.70 Description of feasibility study (a) In connection with each loan RUS shall prepare a feasibility study that includes sections on consolidated loan...

7 CFR 1737.70 - Description of feasibility study

Code of Federal Regulations, 2010 CFR

2010-01-01

... 7 Agriculture 11 2010-01-01 2010-01-01 false Description of feasibility study 1737.70 Section 1737... TELECOMMUNICATIONS LOANS Feasibility Determination Procedures § 1737.70 Description of feasibility study (a) In connection with each loan RUS shall prepare a feasibility study that includes sections on consolidated loan...

How We Design Feasibility Studies

PubMed Central

Bowen, Deborah J.; Kreuter, Matthew; Spring, Bonnie; Cofta-Woerpel, Ludmila; Linnan, Laura; Weiner, Diane; Bakken, Suzanne; Kaplan, Cecilia Patrick; Squiers, Linda; Fabrizio, Cecilia; Fernandez, Maria

2010-01-01

Public health is moving toward the goal of implementing evidence-based interventions. To accomplish this, there is a need to select, adapt, and evaluate intervention studies. Such selection relies, in part, on making judgments about the feasibility of possible interventions and determining whether comprehensive and multilevel evaluations are justified. There exist few published standards and guides to aid these judgments. This article describes the diverse types of feasibility studies conducted in the field of cancer prevention, using a group of recently funded grants from the National Cancer Institute. The grants were submitted in response to a request for applications proposing research to identify feasible interventions for increasing the utilization of the Cancer Information Service among underserved populations. PMID:19362699

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.

Feasibility, safety, and preliminary efficacy of Low Amplitude Seizure Therapy (LAP-ST): A proof of concept clinical trial in man.

PubMed

Youssef, Nagy A; Sidhom, Emad

2017-11-01

Current pulse amplitude used in clinical ECT may be higher than needed. Reducing pulse amplitude may improve focality of the electric field and thus cognitive adverse effects. Here we examine the feasibility, safety, and whether Low Pulse Amplitude Seizure Therapy (LAP-ST, 0.5-0.6A) minimizes cognitive adverse effects while retaining efficacy. Patients with treatment-resistant primary mood (depressive episodes) or psychotic disorders who were clinically indicated to undergo ECT were offered to be enrolled in an open-label study. The study consisted of a full acute course of LAP-ST under standard anesthesia and muscle relaxation. The primary outcome was feasibility of seizure induction. Clinical outcome measures were: time to reorientation (TRO), Mini Mental State Examination, Montgomery Aberg Depression Scale, and Brief Psychiatric Rating Scale, and Clinical Global Impression Scale. Twenty-two patients consented for enrollment in the study. LAP-ST was feasible, and all patients had seizures in the first session. Participants had a quick orientation with median TRO of 4.5min. Treatment was efficacious for both depressive and psychotic symptoms. Relatively small sample size, non-blinded, and no randomization was performed in this initial proof of concept study. This first human preliminary data of a full course of focal LAP-ST demonstrates that seizure induction is feasible. These results, although preliminary, suggest that the LAP-ST compared to the standard ECT techniques may result in less cognitive side effects, but comparable efficacy. Larger studies are needed to replicate these findings. Copyright © 2017 Elsevier B.V. All rights reserved.

7 CFR 1980.442 - Feasibility studies.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 7 Agriculture 14 2011-01-01 2011-01-01 false Feasibility studies. 1980.442 Section 1980.442... studies. A feasibility study by a recognized independent consultant will be required for all loans, except as provided in this paragraph. The cost of the study will be borne by the borrower and may be paid...

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

Whole-body vibration to prevent intensive care unit-acquired weakness: safety, feasibility, and metabolic response.

PubMed

Wollersheim, Tobias; Haas, Kurt; Wolf, Stefan; Mai, Knut; Spies, Claudia; Steinhagen-Thiessen, Elisabeth; Wernecke, Klaus-D; Spranger, Joachim; Weber-Carstens, Steffen

2017-01-09

Intensive care unit (ICU)-acquired weakness in critically ill patients is a common and significant complication affecting the course of critical illness. Whole-body vibration is known to be effective muscle training and may be an option in diminishing weakness and muscle wasting. Especially, patients who are immobilized and not available for active physiotherapy may benefit. Until now whole-body vibration was not investigated in mechanically ventilated ICU patients. We investigated the safety, feasibility, and metabolic response of whole-body vibration in critically ill patients. We investigated 19 mechanically ventilated, immobilized ICU patients. Passive range of motion was performed prior to whole-body vibration therapy held in the supine position for 15 minutes. Continuous monitoring of vital signs, hemodynamics, and energy metabolism, as well as intermittent blood sampling, took place from the start of baseline measurements up to 1 hour post intervention. We performed comparative longitudinal analysis of the phases before, during, and after intervention. Vital signs and hemodynamic parameters remained stable with only minor changes resulting from the intervention. No application had to be interrupted. We did not observe any adverse event. Whole-body vibration did not significantly and/or clinically change vital signs and hemodynamics. A significant increase in energy expenditure during whole-body vibration could be observed. In our study the application of whole-body vibration was safe and feasible. The technique leads to increased energy expenditure. This may offer the chance to treat patients in the ICU with whole-body vibration. Further investigations should focus on the efficacy of whole-body vibration in the prevention of ICU-acquired weakness. Applicability and Safety of Vibration Therapy in Intensive Care Unit (ICU) Patients. ClinicalTrials.gov NCT01286610 . Registered 28 January 2011.

Cervical cancer screening: Safety, acceptability, and feasibility of a single-visit approach in Bulawayo, Zimbabwe.

PubMed

Fallala, Muriel S; Mash, Robert

2015-05-05

Cervical cancer is the commonest cancer amongst African women, and yet preventative services are often inadequate. The purpose of the study was to assess the safety, acceptability and feasibility of visual inspection with acetic acid and cervicography (VIAC) followed by cryotherapy or a loop electrical excision procedure (LEEP) at a single visit for prevention of cancer of the cervix. The United Bulawayo Hospital, Zimbabwe. The study was descriptive, using retrospective data extracted from electronic medical records of women attending the VIAC clinic. Over 24 months 4641 women visited the clinic and were screened for cervical cancer using VIAC. Cryotherapy or LEEP was offered immediately to those that screened positive. Treated women were followed up at three months and one year. The rate of positive results on VIAC testing was 10.8%. Of those who were eligible, 17.0% received immediate cryotherapy, 44.1% received immediate LEEP, 1.9% delayed treatment, and 37.0% were referred to a gynaecologist. No major complications were recorded after cryotherapy or LEEP. Amongst those treated 99.5% expressed satisfaction with their experience. Only 3.2% of those treated at the clinic had a positive result on VIAC one year later. The service was shown to be feasible to sustain over time with the necessary consumables. There were no service-related treatment postponements and the clinic staff and facility were able to meet the demand for the service. A single-visit approach using VIAC, followed by cryotherapy or LEEP, proved to be safe, acceptable and feasible in an urban African setting in Bulawayo, Zimbabwe. Outcomes a year later suggested that treatment had been effective.

Routine transradial access for conventional cerebral angiography: a single operator's experience of its feasibility and safety.

PubMed

Lee, D H; Ahn, J H; Jeong, S S; Eo, K S; Park, M S

2004-10-01

The purpose of this study is to describe a single operator's experience with the feasibility and safety of transradial access in conventional cerebral angiography. 153 patients were enrolled consecutively. Among them, 20 patients were not suitable for transradial access. A Simmons catheter was used. Haemostasis was achieved using a compressive dressing of the wrist. We analysed the success rates of the arterial puncture and the successful catheterization rate for each supra-aortic vessel as well as all complications. The arterial access was successful in 96.3%. The supra-aortic vessels were catheterized with success rates of 99.2% (127/128) for the left subclavian artery and 100% for the other arteries. The mean procedure time was 19.3 min (range 10-55 min). Haemostasis was successfully achieved in every case. The most frequent complication was arm pain which occurred in 37 patients (28.9%). In conclusion, transradial selective cerebral angiography with a reversed-angle catheter is technically feasible and safe. It might be helpful in imaging follow-up of patients with arterial stenting or coil embolisation of the cerebral aneurysms. Modification of the catheter design is required to improve the selectivity of the supra-aortic branches.

Two-week virtual reality training for dementia: Single case feasibility study.

PubMed

McEwen, Daniel; Taillon-Hobson, Anne; Bilodeau, Martin; Sveistrup, Heidi; Finestone, Hillel

2014-01-01

Persons with dementia (PWD) are known to have difficulty with participation and focus during physical activity. Virtual reality (VR) offers a unique medium for motor learning but has only been used previously for cognitive assessment for PWD. Our study had two objectives: (1) investigate the feasibility and safety of an exercise-based VR training program in PWD, and (2) investigate its effects on balance and mobility. The intervention consisted of daily (5 d/wk, 1 h each) VR training sessions for 2 wk for a single research participant. Clinical balance and mobility measures were assessed 1 wk prior to, during, 1 wk following, and 1 mo after the intervention. Postintervention interviews provided qualitative feedback from the participant and his caregivers. Results indicate that VR training is feasible, safe, and enjoyable for PWD. However, balance and mobility measures were unaffected. VR training is well tolerated in a single research participant with dementia and is an engaging medium for participation in exercise.

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

Conducting pilot and feasibility studies.

PubMed

Cope, Diane G

2015-03-01

Planning a well-designed research study can be tedious and laborious work. However, this process is critical and ultimately can produce valid, reliable study findings. Designing a large-scale randomized, controlled trial (RCT)-the gold standard in quantitative research-can be even more challenging. Even the most well-planned study potentially can result in issues with research procedures and design, such as recruitment, retention, or methodology. One strategy that may facilitate sound study design is the completion of a pilot or feasibility study prior to the initiation of a larger-scale trial. This article will discuss pilot and feasibility studies, their advantages and disadvantages, and implications for oncology nursing research. 
.

Adipose-derived mesenchymal stem cells (AdMSC) for the treatment of secondary-progressive multiple sclerosis: A triple blinded, placebo controlled, randomized phase I/II safety and feasibility study.

PubMed

Fernández, Oscar; Izquierdo, Guillermo; Fernández, Victoria; Leyva, Laura; Reyes, Virginia; Guerrero, Miguel; León, Antonio; Arnaiz, Carlos; Navarro, Guillermo; Páramo, Maria Dolores; Cuesta, Antonio De la; Soria, Bernat; Hmadcha, Abdelkrim; Pozo, David; Fernandez-Montesinos, Rafael; Leal, Maria; Ochotorena, Itziar; Gálvez, Patricia; Geniz, Maria Angeles; Barón, Francisco Javier; Mata, Rosario; Medina, Cristina; Caparrós-Escudero, Carlos; Cardesa, Ana; Cuende, Natividad

2018-01-01

Currently available treatments for secondary progressive multiple sclerosis(SPMS) have limited efficacy and/or safety concerns. Adipose-mesenchymal derived stem cells(AdMSCs) represent a promising option and can be readily obtained using minimally invasive procedures. In this triple-blind, placebo-controlled study, cell samples were obtained from consenting patients by lipectomy and subsequently expanded. Patients were randomized to a single infusion of placebo, low-dose(1x106cells/kg) or high-dose(4x106cells/kg) autologous AdMSC product and followed for 12 months. Safety was monitored recording adverse events, laboratory parameters, vital signs and spirometry. Expanded disability status score (EDSS), magnetic-resonance-imaging, and other measures of possible treatment effects were also recorded. Thirty-four patients underwent lipectomy for AdMSCs collection, were randomized and thirty were infused (11 placebo, 10 low-dose and 9 high-dose); 4 randomized patients were not infused because of karyotype abnormalities in the cell product. Only one serious adverse event was observed in the treatment arms (urinary infection, considered not related to study treatment). No other safety parameters showed changes. Measures of treatment effect showed an inconclusive trend of efficacy. Infusion of autologous AdMSCs is safe and feasible in patients with SPMS. Larger studies and probably treatment at earlier phases would be needed to investigate the potential therapeutic benefit of this technique.

Can exercise suppress tumour growth in advanced prostate cancer patients with sclerotic bone metastases? A randomised, controlled study protocol examining feasibility, safety and efficacy

PubMed Central

Newton, Robert U; Spry, Nigel A; Taaffe, Dennis R; Chambers, Suzanne K; Feeney, Kynan T; Joseph, David J; Redfern, Andrew D; Ferguson, Tom; Galvão, Daniel A

2017-01-01

Introduction Exercise may positively alter tumour biology through numerous modulatory and regulatory mechanisms in response to a variety of modes and dosages, evidenced in preclinical models to date. Specifically, localised and systemic biochemical alterations produced during and following exercise may suppress tumour formation, growth and distribution by virtue of altered epigenetics and endocrine–paracrine activity. Given the impressive ability of targeted mechanical loading to interfere with metastasis-driven tumour formation in human osteolytic tumour cells, it is of equal interest to determine whether a similar effect is observed in sclerotic tumour cells. The study aims to (1) establish the feasibility and safety of a combined modular multimodal exercise programme with spinal isometric training in advanced prostate cancer patients with sclerotic bone metastases and (2) examine whether targeted and supervised exercise can suppress sclerotic tumour growth and activity in spinal metastases in humans. Methods and analysis A single-blinded, two-armed, randomised, controlled and explorative phase I clinical trial combining spinal isometric training with a modular multimodal exercise programme in 40 men with advanced prostate cancer and stable sclerotic spinal metastases. Participants will be randomly assigned to (1) the exercise intervention or (2) usual medical care. The intervention arm will receive a 3-month, supervised and individually tailored modular multimodal exercise programme with spinal isometric training. Primary endpoints (feasibility and safety) and secondary endpoints (tumour morphology; biomarker activity; anthropometry; musculoskeletal health; adiposity; physical function; quality of life; anxiety; distress; fatigue; insomnia; physical activity levels) will be measured at baseline and following the intervention. Statistical analyses will include descriptive characteristics, t-tests, effect sizes and two-way (group × time) repeated

Can exercise suppress tumour growth in advanced prostate cancer patients with sclerotic bone metastases? A randomised, controlled study protocol examining feasibility, safety and efficacy.

PubMed

Hart, Nicolas H; Newton, Robert U; Spry, Nigel A; Taaffe, Dennis R; Chambers, Suzanne K; Feeney, Kynan T; Joseph, David J; Redfern, Andrew D; Ferguson, Tom; Galvão, Daniel A

2017-05-30

Exercise may positively alter tumour biology through numerous modulatory and regulatory mechanisms in response to a variety of modes and dosages, evidenced in preclinical models to date. Specifically, localised and systemic biochemical alterations produced during and following exercise may suppress tumour formation, growth and distribution by virtue of altered epigenetics and endocrine-paracrine activity. Given the impressive ability of targeted mechanical loading to interfere with metastasis-driven tumour formation in human osteolytic tumour cells, it is of equal interest to determine whether a similar effect is observed in sclerotic tumour cells. The study aims to (1) establish the feasibility and safety of a combined modular multimodal exercise programme with spinal isometric training in advanced prostate cancer patients with sclerotic bone metastases and (2) examine whether targeted and supervised exercise can suppress sclerotic tumour growth and activity in spinal metastases in humans. A single-blinded, two-armed, randomised, controlled and explorative phase I clinical trial combining spinal isometric training with a modular multimodal exercise programme in 40 men with advanced prostate cancer and stable sclerotic spinal metastases. Participants will be randomly assigned to (1) the exercise intervention or (2) usual medical care. The intervention arm will receive a 3-month, supervised and individually tailored modular multimodal exercise programme with spinal isometric training. Primary endpoints (feasibility and safety) and secondary endpoints (tumour morphology; biomarker activity; anthropometry; musculoskeletal health; adiposity; physical function; quality of life; anxiety; distress; fatigue; insomnia; physical activity levels) will be measured at baseline and following the intervention. Statistical analyses will include descriptive characteristics, t-tests, effect sizes and two-way (group × time) repeated-measures analysis of variance (or analysis of

Feasibility, safety, acceptability, and preliminary efficacy of measurement-based care depression treatment for HIV patients in Bamenda, Cameroon.

PubMed

Pence, Brian W; Gaynes, Bradley N; Atashili, Julius; O'Donnell, Julie K; Kats, Dmitry; Whetten, Kathryn; Njamnshi, Alfred K; Mbu, Tabenyang; Kefie, Charles; Asanji, Shantal; Ndumbe, Peter

2014-06-01

Depression affects 18-30 % of HIV-infected patients in Africa and is associated with greater stigma, lower antiretroviral adherence, and faster disease progression. However, the region's health system capacity to effectively identify and treat depression is limited. Task-shifting models may help address this large mental health treatment gap. Measurement-Based Care (MBC) is a task-shifting model in which a Depression Care Manager guides a non-psychiatric (e.g., HIV) provider in prescribing and managing antidepressant treatment. We adapted MBC for depressed HIV-infected patients in Cameroon and completed a pilot study to assess feasibility, safety, acceptability, and preliminary efficacy. We enrolled 55 participants; all started amitriptyline 25-50 mg daily at baseline. By 12 weeks, most remained at 50 mg daily (range 25-125 mg). Median (interquartile range) PHQ-9 depressive severity scores declined from 13 (12-16) (baseline) to 2 (0-3) (week 12); 87 % achieved depression remission (PHQ-9 <5) by 12 weeks. Intervention fidelity was high: HIV providers followed MBC recommendations at 96 % of encounters. Most divergences reflected a failure to increase dose when indicated. No serious and few bothersome side effects were reported. Most suicidality (prevalence 62 % at baseline; 8 % at 12 weeks) was either passive or low-risk. Participant satisfaction was high (100 %), and most participants (89 %) indicated willingness to pay for medications if MBC were implemented in routine care. The adapted MBC intervention demonstrated high feasibility, safety, acceptability, and preliminary efficacy in this uncontrolled pilot study. Further research should assess whether MBC could improve adherence and HIV outcomes in this setting.

Knowledge, attitudes, beliefs, values, preferences, and feasibility in relation to the use of injection safety devices in healthcare settings: a systematic review.

PubMed

Tarabay, Rami; El Rassi, Rola; Dakik, Abeer; Harb, Alain; Ballout, Rami A; Diab, Batoul; Khamassi, Selma; Akl, Elie A

2016-07-13

Adopting technologies such as injection safety devices in healthcare settings can enhance injection safety. Developing guidelines for appropriate adoption of such technologies need to consider factors beyond evidence for their health effects. The objective of this study is to systematically review the published literature for evidence among healthcare workers and patients about knowledge, attitudes, beliefs, values, preferences, and feasibility in relation to the use of injection safety devices in healthcare settings. We included both qualitative and quantitative studies conducted with the general public, patients, and healthcare workers, administrators, or policy makers. We searched MEDLINE, EMBASE, CINHAL and CENTRAL. We used a duplicate and independent approach to title and abstract screening, full text screening, data abstraction and risk of bias assessment. Out of a total of 6568 identified citations, we judged fourteen studies as eligible for this systematic review. All these studies were surveys, conducted with healthcare workers in high-income countries. We did not identify any qualitative study, or a study of the general public, patients, healthcare administrators or policy makers. We did not identify any study assessing knowledge, or values assigned to outcomes relevant to injection safety devices. Each of the included studies suffered from methodological limitations, which lowers our confidence in their findings. Based on the findings of six studies, the injection safety devices were generally perceived as easy to use and as an improvement compared with conventional syringes. Some of these studies reported few technical problems while using the devices. In three studies assessing perceived safety, the majority of participants judged the devices as safe. Two studies reported positive perceptions of healthcare workers regarding patient tolerance of these injection safety devices. One study found that less than half the nurses felt comfortable using the

Safety and feasibility of countering neurological impairment by intravenous administration of autologous cord blood in cerebral palsy

PubMed Central

2012-01-01

Backgrounds We conducted a pilot study of the infusion of intravenous autologous cord blood (CB) in children with cerebral palsy (CP) to assess the safety and feasibility of the procedure as well as its potential efficacy in countering neurological impairment. Methods Patients diagnosed with CP were enrolled in this study if their parents had elected to bank their CB at birth. Cryopreserved CB units were thawed and infused intravenously over 10~20 minutes. We assessed potential efficacy over 6 months by brain magnetic resonance imaging (MRI)-diffusion tensor imaging (DTI), brain perfusion single-photon emission computed tomography (SPECT), and various evaluation tools for motor and cognitive functions. Results Twenty patients received autologous CB infusion and were evaluated. The types of CP were as follows: 11 quadriplegics, 6 hemiplegics, and 3 diplegics. Infusion was generally well-tolerated, although 5 patients experienced temporary nausea, hemoglobinuria, or urticaria during intravenous infusion. Diverse neurological domains improved in 5 patients (25%) as assessed with developmental evaluation tools as well as by fractional anisotropy values in brain MRI-DTI. The neurologic improvement occurred significantly in patients with diplegia or hemiplegia rather than quadriplegia. Conclusions Autologous CB infusion is safe and feasible, and has yielded potential benefits in children with CP. PMID:22443810

Cervical cancer prevention: safety, acceptability, and feasibility of a single-visit approach in Accra, Ghana.

PubMed

Blumenthal, Paul D; Gaffikin, Lynne; Deganus, Sylvia; Lewis, Robbyn; Emerson, Mark; Adadevoh, Sydney

2007-04-01

The purpose of this study was to assess the safety and acceptability of a single-visit approach to cervical cancer prevention combining visual inspection of the cervix with acetic acid wash (VIA) and cryotherapy. The study was observational. Nine clinicians were trained in VIA and cryotherapy. Over 18 months 3665 women were VIA-tested. If positive and eligible, cryotherapy was offered immediately. Treated women were followed-up at 3 months and 1 year. The test-positive rate was 13.2%. Of those eligible, 70.2% and 21% received immediate or delayed treatment, respectively. No major complications were recorded, and 5.6% presented for a perceived problem post-cryotherapy. Among those treated over 90% expressed satisfaction with their experience, and 96% had an indentifiable squamo-columnar junction. Only 2.6% (6/232) were test positive, 1-year posttreatment. A single-visit approach using VIA and cryotherapy proved to be safe, acceptable, and feasible in an urban African setting.

Feasibility and Safety of a Transthoracic Pneumostoma Airway Bypass in Severe Emphysema Patients.

PubMed

Snell, Gregory I; Holsworth, Lynda; Khorramnia, Sadie; Westall, Glen P; Williams, Trevor J; Marasco, Silvana; Gooi, Julian H

2017-01-01

Emphysema is characterised by airflow obstruction, hyperinflation, and resultant dyspnoea. It is worth investigating whether decompression improves lung mechanics and enhances quality of life (QoL). The purpose of this study was to describe the feasibility and safety of creating a transthoracic pneumostoma to enable lung reduction. A transthoracic 10-mm diameter Portaero Access Tube (Portaero™, Cupertino, CA, USA) was implanted via a third intercostal space incision in 15 severe emphysema patients [mean age 63 years, forced expiratory volume in 1 s 54% predicted, diffusing capacity for carbon monoxide 31% predicted, residual volume 246% predicted, Six-Minute Walk Test 296 m]. Four weeks later, an 8-mm Portaero Disposable Tube (3-8 cm in length) was substituted and changed daily thereafter. The targeted primary endpoints were a ≥12% increase in forced expiratory volume in 1 s and a decrease of ≥4 points in Saint George's Respiratory Questionnaire score at 6 months. Sixteen procedures were performed on 15 patients, complicated by 1 intercostal haemorrhage, 1 pneumothorax, and universal mild surgical emphysema. Early patency issues were common, but often responded to external endoscopic debridement or argon plasma laser. Three-month patency was achieved in 9 of 15 patients, and 6 of these had long-term patency (mean of 4 years). Patency was associated with potentially useful long-term improvements or stability in spirometry, residual volume, and QoL. However, the primary endpoints were not met at 6 months. The creation and maintenance of a transthoracic pneumostoma appears feasible and safe in patients with severe emphysema. Further studies refining patient selection (perhaps via chest computed tomography collateral ventilation and fissure assessments), techniques, and tube materials are suggested. © 2017 S. Karger AG, Basel.

Cape Blanco wind farm feasibility study

NASA Astrophysics Data System (ADS)

1987-11-01

The Cape Blanco Wind Farm (CBWF) Feasibility Study was undertaken as a prototype for determining the feasibility of proposals for wind energy projects at Northwest sites. It was intended to test for conditions under which wind generation of electricity could be commercially feasible, not by another abstract survey of alternative technologies, but rather through a site-specific, machine-specific analysis of one proposal. Some of the study findings would be most pertinent to the Cape Blanco site - local problems require local solutions. Other findings would be readily applicable to other sites and other machines, and study methodologies would be designed to be modified for appraisal of other proposals. This volume discusses environmental, economic, and technical issues of the Wind Farm.

7 CFR 1980.442 - Feasibility studies.

Code of Federal Regulations, 2013 CFR

2013-01-01

...) PROGRAM REGULATIONS (CONTINUED) GENERAL Business and Industrial Loan Program § 1980.442 Feasibility... a feasibility study for loans to existing businesses when the financial history of the business, the current financial condition of the business, and guarantees or other collateral offered for the loan are...

7 CFR 1980.442 - Feasibility studies.

Code of Federal Regulations, 2014 CFR

2014-01-01

...) PROGRAM REGULATIONS (CONTINUED) GENERAL Business and Industrial Loan Program § 1980.442 Feasibility... a feasibility study for loans to existing businesses when the financial history of the business, the current financial condition of the business, and guarantees or other collateral offered for the loan are...

7 CFR 1980.442 - Feasibility studies.

Code of Federal Regulations, 2012 CFR

2012-01-01

...) PROGRAM REGULATIONS (CONTINUED) GENERAL Business and Industrial Loan Program § 1980.442 Feasibility... a feasibility study for loans to existing businesses when the financial history of the business, the current financial condition of the business, and guarantees or other collateral offered for the loan are...

Cooking Healthy, Eating Smart (CHES): Evaluating the feasibility of using volunteers to deliver nutrition and food safety education to rural older adults

NASA Astrophysics Data System (ADS)

Getty, Morgan

Due to their limited resources, rural, older adults in the United States are at risk for poor diet-related health outcomes. Nutrition education is a key component in improving health outcomes in older adults. Cooking Healthy, Eating Smart (CHES) is a nine-lesson curriculum designed to teach rural, older adults culturally appropriate nutrition and food safety information. Funding to hire health professionals to deliver such a curriculum is limited, presenting the need to explore a less expensive mode of dissemination. In this community-based, participatory research study, a formative evaluation and feasibility study were conducted to examine the use of volunteers to deliver a nutrition and food safety curriculum to rural, older adults in South Carolina. Seven focus groups were conducted with members of the South Carolina Family and Community Leaders (SCFCL) and members of the American Association of Retired Persons (AARP) in the four regions of South Carolina to explore barriers and facilitators of volunteers delivering CHES (N=65 participants). The focus group findings informed the development of the volunteer training manual. A comparative case study method was used to examine the feasibility of a volunteer-based approach by observing and describing the delivery of CHES by two groups of volunteers in SC. The case study findings, including volunteer knowledge change, self-efficacy change, curriculum experience, program experience, and project team observations of volunteers indicated that using volunteers to deliver CHES is a plausible approach with the assistance of paid staff or project team members.

Peer Review of “LDT Weight Reduction Study with Crash Model, Feasibility and Detailed Cost Analyses – Chevrolet Silverado 1500 Pickup”

EPA Science Inventory

The contractor will conduct an independent peer review of FEV’s light-duty truck (LDT) mass safety study, “Light-Duty Vehicle Weight Reduction Study with Crash Model, Feasibility and Detailed Cost Analysis – Silverado 1500”, and its corresponding computer-aided engineering (CAE) ...

Bladder tissue engineering using biocompatible nanofibrous electrospun constructs: feasibility and safety investigation.

PubMed

Shakhssalim, Nasser; Dehghan, Mohammad Mehdi; Moghadasali, Reza; Soltani, Mohammad Hossein; Shabani, Iman; Soleimani, Masoud

2012-01-01

To investigate the feasibility and safety of using biocompatible, nanofibrous electrospun polycaprolactone (PCL) and combination of polylactic acid (PLLA) and PCL mats in a canine model. Plasma-treated electrospun unseeded mats were implanted in three dogs. The first dog was sacrificed after 3 months and the second and third ones after 4 months, and then, the graft was examined macroscopically with subsequent morphological and histochemical evaluation. Both films showed high levels of cell infiltration and tissue formation, but body response to PLLA/PCL mat in comparison to PCL mat was very low. All three implantation models showed the same light microscopic morphology, immunohistochemistry, and scanning electron microscopy results; nevertheless, only the PCL/PLLA model showed favorable clinical results. Based on these data, nanofibrous PLLA/PCL scaffolding could be a suitable material for the bladder tissue engineering; however, it deserves further investigations.

Magnetic resonance image guided transurethral ultrasound prostate ablation: a preclinical safety and feasibility study with 28-day followup.

PubMed

Burtnyk, Mathieu; Hill, Tracy; Cadieux-Pitre, Heather; Welch, Ian

2015-05-01

We determine the safety and feasibility of magnetic resonance image guided transurethral ultrasound prostate ablation using active temperature feedback control in a preclinical canine model with 28-day followup. After a long acclimatization period we performed ultrasound treatment in 8 subjects using the magnetic resonance image guided TULSA-PRO™ transurethral ultrasound prostate ablation system. Comprehensive examinations and observations were done before and throughout the 28-day followup, including assessment of clinically significant treatment related adverse events. In addition to gross pathology evaluation, extensive histopathological analysis was done to assess cell kill inside and outside the prostate. We evaluated prostate conformal heating by comparing the spatial difference between the treatment plan and the 55C isotherm measured on magnetic resonance imaging thermometry acquired during treatment. These findings were confirmed on contrast enhanced magnetic resonance imaging immediately after treatment and at 28 days. Clinically there were no adverse events in any of the 8 subjects throughout the 28-day followup. All subjects had normal urinary and bowel function. Gross necropsy and histology confirmed that the intended thermal cell kill was confined to the prostate. No surrounding tissue was damaged, including the rectum and the external urinary sphincter. Conformal heating was achieved with an average -0.9 mm accuracy and 0.9 mm precision. Contrast enhanced magnetic resonance imaging and histological analysis confirmed tissue ablation in targeted areas of the prostate. Urethral tissue was spared from thermal damage. Magnetic resonance image guided transurethral ultrasound is a safe, feasible procedure for accurate and precise conformal thermal ablation of prostate tissue, as demonstrated in a preclinical model with 28-day followup. Copyright © 2015 American Urological Association Education and Research, Inc. Published by Elsevier Inc. All rights

Assessing the feasibility of distributing child poison safety messages through three existing parent information pathways.

PubMed

Gibbs, L; Waters, E; Robinson, J; Young, S; Hutchinson, A

2009-12-01

The objective of this exploratory study was to assess the feasibility of increasing parents' poison safety awareness and behaviours using existing pathways. The aim was to compare the release of true stories of child unintentional poisoning via three modes: (a) parent "networker"; (b) maternal and child health nurse; (c) the media. The stories spread by the parent networker were readily recalled by the parents, with examples of changed behaviour and spreading of the stories. Parents who were part of the maternal and child health nurse strategy were not able to recall the stories without prompts. The media strategy could not be implemented because of difficulties finding parents ready to publicise their story. Given that it is an exploratory study, it is not possible to draw conclusions about the effectiveness of each of the intervention strategies. However, it appears that a low-resource intervention using stories shared via parent networkers may have exciting potential as a health promotion tool. A stronger study design to examine its effectiveness is proposed.

Renewable Energy Feasibility Study Final Report

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

Rooney, Tim

2013-10-30

The Gila River Indian Community (GRIC or the Community) contracted the ANTARES Group, Inc. (“ANTARES”) to assess the feasibility of solar photovoltaic (PV) installations. A solar energy project could provide a number of benefits to the Community in terms of potential future energy savings, increased employment, environmental benefits from renewable energy generation and usage, and increased energy self-sufficiency. The study addresses a number of facets of a solar project’s overall feasibility, including: Technical appropriateness; Solar resource characteristics and expected system performance; Levelized cost of electricity (LCOE) economic assessment. The Gila River Indian Community (GRIC or the Community) contracted the ANTARESmore » Group, Inc. (“ANTARES”) to prepare a biomass resource assessment study and evaluate the feasibility of a bioenergy project on Community land. A biomass project could provide a number of benefits to the Community in terms of increased employment, environmental benefits from renewable energy generation and usage, and increased energy self-sufficiency. The study addresses a number of facets of a biomass project’s overall feasibility, including: Resource analysis and costs; Identification of potential bioenergy projects; Technical and economic (levelized cost of energy) modeling for selected project configuration.« less

Osteopathic Manual Treatment for Amyotrophic Lateral Sclerosis: A Feasibility Pilot Study

PubMed Central

Maggiani, Alberto; Tremolizzo, Lucio; Valentina, Andrea Della; Mapelli, Laurent; Sosio, Silvia; Milano, Valeria; Bianchi, Manuel; Badi, Francesco; Lavazza, Carolina; Grandini, Marco; Corna, Giovanni; Prometti, Paola; Lunetta, Christian; Riva, Nilo; Ferri, Alessandra; Lanfranconi, Francesca

2016-01-01

Background: Current interventions in amyotrophic lateral sclerosis (ALS) are focused on supporting quality of life (QoL) and easing pain with a multidisciplinary approach. Objective: Primary aim of this pilot work assessed feasibility, safety, tolerability and satisfaction of osteopathic manual treatment (OMT) in 14 ALS outpatients. Methods: Patients were randomized according to an initial single-blind design (12 weeks, T0-T1), in order to receive OMT (weekly for 4 weeks, and fortnightly for the following 8 weeks) versus usual-care (n=7 each group), followed by an OMT open period (T1-T2, once a week for 8 weeks, n=10). Secondary aims included blind osteopathic assessment of somatic dysfunctions (SD) for goal attainment scale (GAS) calculation, Brief Pain Inventory-short form and McGill QoL-16 items. Results: OMT was demonstrated feasible and safe and patients displayed high satisfaction (T1-VAS=8.34 ± 0.46; T2-VAS=8.52 ± 0.60). Considering secondary aims no significant differences emerged. Finally, at study entry (T0), a cervico-dorsal SD was found in 78% of ALS patients versus 28% of healthy matched controls (p<0.01). Conclusion: OMT was found feasible, safe and satisfactory in ALS. The lack of secondary aim differences can be due to the limited sample size. OMT could be an interesting option to explore in ALS. PMID:27651843

Integrating Cost-effective Rollover Protective Structure Installation in High School Agricultural Mechanics: A Feasibility Study.

PubMed

Mazur, Joan; Vincent, Stacy; Watson, Jennifer; Westneat, Susan

2015-01-01

This study with three Appalachian county agricultural education programs examined the feasibility, effectiveness, and impact of integrating a cost-effective rollover protective structure (CROPS) project into high school agricultural mechanics classes. The project aimed to (1) reduce the exposure to tractor overturn hazards in three rural counties through the installation of CROPS on seven tractors within the Cumberland Plateau in the east region; (2) increase awareness in the targeted rural communities of cost-effective ROPS designs developed by the National Institution for Occupational Safety and Health (NIOSH) to encourage ROPS installations that decrease the costs of a retrofit; (3) test the feasibility of integration of CROPS construction and installations procedures into the required agricultural mechanics classes in these agricultural education programs; and (4) explore barriers to the implementation of this project in high school agricultural education programs. Eighty-two rural students and three agricultural educators participated in assembly and installation instruction. Data included hazard exposure demographic data, knowledge and awareness of CROPS plans, and pre-post knowledge of construction and assessment of final CROPS installation. Findings demonstrated the feasibility and utility of a CROPS education program in a professionally supervised secondary educational setting. The project promoted farm safety and awareness of availability and interest in the NIOSH Cost-effective ROPS plans. Seven CROPS were constructed and installed. New curriculum and knowledge measures also resulted from the work. Lessons learned and recommendations for a phase 2 implementation and further research are included.

[The relevance of core muscles in ice hockey players: a feasibility study].

PubMed

Rogan, S; Blasimann, A; Nyffenegger, D; Zimmerli, N; Radlinger, L

2013-12-01

Good core strength is seen as a condition for high performance in sports. In general, especially maximum voluntary contraction (MVC) and strength endurance (SE) measurements of the core muscles are used. In addition, a few studies can be found that examine the core muscles in terms of MVC, rate of force development (RFD) and SE. Primary aims of this feasibility study were to investigate the feasibility regarding recruiting process, compliance and safety of the testing conditions and raise the force capabilities MVC, RFD and SE of the core muscles in amateur ice hockey players. Secondarily, tendencies of correlations between muscle activity and either shot speed and sprint time shall be examined. In this feasibility study the recruitment process has been approved by 29 ice hockey players, their adherence to the study measurements of trunk muscles, and safety of the measurements was evaluated. To determine the MVC, RFD and SE for the ventral, lateral and dorsal core muscles a dynamic force measurement was performed. To determine the correlation between core muscles and shot speed and 40-m sprint, respectively, the rank correlation coefficient (rho) from Spearman was used. The recruited number of eight field players and one goal-keeper was not very high. The compliance with 100 % was excellent. The players reported no adverse symptoms or injuries after the measurements. The results show median values for the ventral core muscles for MVC with 46.5 kg for RFD with 2.23 m/s2 and 96 s for the SE. For lateral core muscle median values of the lateral core muscles for MVC with 71.10 kg, RFD with 2.59 m/s2 and for SE over 66 s were determined. The dorsal core muscles shows values for MVC 69.7 kg, for RFD 3.39 m/s2 and for SE of 75 s. High correlations between MVC of the ventral core muscles (rho = -0.721, p = 0.021), and between the SE of the ventral core muscles (rho = 0.787, p = 0.012), and the shot velocity rate were determined. Another

Feasibility and safety of elective transradial coronary intervention in Asian females.

PubMed

Maddury, Jyotsna; Kaushik, Manu; Madhavapeddi, Aditya; Babu, Srinivas; Kumar, Narendra; Varma, J L N; Alla, Venkata

2011-03-01

Transradial access for angioplasty and percutaneous intervention (PCI) has become more popular across the world due to lower risk of bleeding and better patient comfort. It has been shown to be effective and feasible in the Western population. However, there is a relative paucity of similar data for small-statured females, especially from Asian countries. Given the increased theoretical risk of local complications due to smaller-sized radial arteries in such females, feasibility and safety of transradial PCI (rPCI) needs to be better established in this group. We present observational data for rPCI from a 3-year period at a single tertiary care center in South Asia. Data were collected on all female patients who underwent rPCI from January 2005 to December 2007. Primary outcomes assessed were procedure failure rate and complication rate. Secondary outcomes included death, recurrence of myocardial infarction, anginal symptoms or other complaints. Outcomes were recorded post-procedurally in the hospital and after discharge for up to 6 months. A total of 93 patients were included for final data analysis. Average patient age was 57.5 ± 10.3 years, with average height of 151.7 ± 8.4 cm and average weight of 58.1 ± 12.5 kg. Seventy patients (75.3%) underwent angioplasty or percutaneous intervention (PCI) for ACS and 23 (24.7%) for chronic stable angina refractory to medical therapy. A total of 118 lesions were treated in 90 patients. Ninety-one lesions (77.1%) were classified as Type B2 and Type C according to modified American College of Cardiology/American Heart Association lesion morphology criteria. Three cases of procedure failure accounted for a failure rate of 3.23%. No specified complications were noted in any of the patients. At 6-month follow-up, no deaths were observed. Two patients developed acute myocardial infarction and 16 patients (17.7%) had recurrence of anginal symptoms. Radial artery angioplasty and stenting is feasible and safe in Asian females

A feasibility study of a 3-day basal-bolus insulin delivery device in individuals with type 2 diabetes.

PubMed

Mader, Julia K; Lilly, Leslie C; Aberer, Felix; Korsatko, Stefan; Strock, Ellie; Mazze, Roger S; Damsbo, Peter; Pieber, Thomas R

2014-05-01

This study tested the feasibility of transition from multiple daily injections (MDI) to a 3-day, basal-bolus insulin delivery device (PaQ) for type 2 diabetes (T2D). Twenty MDI-treated individuals with T2D with HbA(1c) ≤9% (75 mmol/mol) were enrolled in a single-center, single-arm pilot study, lasting three 2-week periods: baseline (MDI), transition to PaQ, and PaQ therapy. Feasibility of use, glycemic control, safety, and patient satisfaction were assessed. Nineteen participants transitioned to PaQ treatment and demonstrated competency in assembling, placing, and using the device. Self-monitored blood glucose and blinded continuous glucose-monitoring data showed glycemic control similar to MDI. Study participants reported high satisfaction and device acceptance. PaQ treatment is both feasible and acceptable in individuals with T2D. Transition from MDI is easy and safe. PaQ treatment might lead to better therapy adherence and improvements in glycemic control and clinical outcomes.

A prospective, multicenter pilot study to investigate the feasibility and safety of a 1-year controlled exercise training after adjuvant chemotherapy in colorectal cancer patients.

PubMed

Piringer, Gudrun; Fridrik, Michael; Fridrik, Alfred; Leiherer, Andreas; Zabernigg, August; Greil, Richard; Eisterer, Wolfgang; Tschmelitsch, Jörg; Lang, Alois; Frantal, Sophie; Burgstaller, Sonja; Gnant, Michael; Thaler, Josef

2018-04-01

Despite advances in adjuvant chemotherapy, 20-30% of patients in stages II-III colorectal cancer will eventually relapse. Observational studies showed a reduction in relapse rate, colon cancer-specific mortality, and overall mortality by physical activity. Results from prospective randomized interventional studies to confirm these observational data are lacking. The aims of this prospective single-arm multicenter pilot study are to evaluate feasibility and safety of exercise training after adjuvant chemotherapy in colorectal cancer patients. The training was performed three times per week for 1 year and was increased gradually in three phases until reaching 18 metabolic equivalent task hours per week. Overall, 30 patients were included. The planned training intensity could be achieved in all three phases. Patients experienced a performance increase of median 35.5 watt, a weight-loss of a median of 3.0 kg, and a reduction in body fat content of median 1.0% during this exercise training. The analysis showed early study termination due to non-compliance in 10/30 patients (33.3%), disease progression in 4 patients (13.3%), and serious adverse events in 2 patients (6.7%). About half of patients (46.7%) completed the pilot study as planned. Biomarker analysis from 20 patients showed a non-significant reduction in insulin-like growth factor 1 (IGF-1), insulin-like growth factor 2 (IGF-2) and insulin-like growth factor binding protein 3 (IGF-BP3) levels, significant increases in adiponectin and leptin levels, and a non-significant increase in C-peptide levels. Exercise training is feasible in patients with colorectal cancer after completion of adjuvant chemotherapy. The main problem encountered during the study was compliance. To improve compliance of exercise training, several measures were adapted for the upcoming prospective randomized ABCSG C08 Exercise II study.

Feasibility of a Video-Based Advance Care Planning Website to Facilitate Group Visits among Diverse Adults from a Safety-Net Health System.

PubMed

Zapata, Carly; Lum, Hillary D; Wistar, Emily; Horton, Claire; Sudore, Rebecca L

2018-02-20

Primary care providers in safety-net settings often do not have time to discuss advance care planning (ACP). Group visits (GV) may be an efficient means to provide ACP education. To assess the feasibility and impact of a video-based website to facilitate GVs to engage diverse adults in ACP. Feasibility pilot among patients who were ≥55 years of age from two primary care clinics in a Northern California safety-net setting. Participants attended two 90-minute GVs and viewed the five steps of the movie version of the PREPARE website ( www.prepareforyourcare.org ) concerning surrogates, values, and discussing wishes in video format. Two clinician facilitators were available to encourage participation. We assessed pre-to-post ACP knowledge, whether participants designated a surrogate or completed an advance directive (AD), and acceptability of GVs and PREPARE materials. We conducted two GVs with 22 participants. Mean age was 64 years (±7), 55% were women, 73% nonwhite, and 55% had limited literacy. Knowledge improved about surrogate designation (46% correct pre vs. 85% post, p = 0.01) and discussing decisions with others (59% vs. 90%, p = 0.01). Surrogate designation increased (48% vs. 85%, p = 0.01) and there was a trend toward AD completion (9% vs. 24%, p = 0.21). Participants rated the GVs and PREPARE materials a mean of 8 (±3.1) on a 10-point acceptability scale. Using the PREPARE movie to facilitate ACP GVs for diverse adults in safety net, primary care settings is feasible and shows potential for increasing ACP engagement.

A Feasibility Study of Virtual Reality Exercise in Elderly Patients with Hematologic Malignancies Receiving Chemotherapy.

PubMed

Tsuda, Kenji; Sudo, Kazuaki; Goto, Goro; Takai, Makiko; Itokawa, Tatsuo; Isshiki, Takahiro; Takei, Naoko; Tanimoto, Tetsuya; Komatsu, Tsunehiko

2016-01-01

Adherence to rehabilitation exercise is much lower in patients with hematologic malignancies (22.5-45.8%) than in patients with solid tumors (60-85%) due to the administration of more intensive chemotherapeutic regimens in the former. Virtual reality exercise can be performed even in a biological clean room and it may improve the adherence rates in elderly patients with hematologic malignancies. Thus, in this pilot study, we aimed to investigate the feasibility and safety of virtual reality exercise intervention using Nintendo Wii Fit in patients with hematologic malignancies receiving chemotherapy. In this feasibility study, 16 hospitalized patients with hematologic malignancies aged ≥60 years performed virtual reality exercise for 20 minutes using the Nintendo Wii Fit once a day, five times a week, from the start of chemotherapy until hospital discharge. The adherence rate, safety, and physical and psychological performances were assessed. The adherence rate for all 16 patients was 66.5%. Nine patients completed the virtual reality exercise intervention with 88 sessions, and the adherence rate was 62.0%. No intervention-related adverse effects >Grade 2, according to National Cancer Institute Common Terminology Criteria for Adverse Events version 3.0, were observed. We noted maintenance of the physical performance (e.g., Barthel index, handgrip strength, knee extension strength, one-leg standing time, and the scores of timed up and go test and Instrumental Activities of Daily Living) and psychosocial performance (e.g., score of hospital anxiety and depression scale). Virtual reality exercise using the Wii Fit may be feasible, safe and efficacious, as demonstrated in our preliminary results, for patients with hematologic malignancies receiving chemotherapy.

Reducing safety risk among underserved caregivers with an Alzheimer's home safety program.

PubMed

Levy-Storms, Lené; Cherry, Debra L; Lee, Linda J; Wolf, Sheldon M

2017-09-01

Older adults living with Alzheimer's disease (AD) experience more of the types of accidents and injuries prevalent among older adults. Relatively few studies specifically on safety risks have included older adults of color and tested interventions. This pilot study tested the feasibility and evaluability of educating Hispanic and African American caregivers of patients living with AD about reducing safety risks in their homes. This outpatient memory clinic-based intervention study included a pre-/post-test survey design with two nonequivalent groups and predominately serves Hispanic and African Americans. Of 60 eligible caregivers, 67% participated in a tailored, safety training class with an optional follow-up call. The results indicate a reduction in some safety risks compared to baseline and/or a no intervention group, respectively, including leaving patients at home alone part-time (p < .01 and p < .01), getting lost (p < .05 and p < .05), going outdoors alone less often (p < .05 and p < .01), and giving themselves medicine (p < .05 and p < .01). At post-test, 47 clinically significant instances occurred, in which caregivers who participated in the intervention self-reported patients living with AD to be 'completely safe' in one or more of the safety risk items compared to 8 instances among those who did not. This pilot pre/post design with non-equivalent groups study needs refinement in a future randomized control trial. Despite limitations, this pilot study demonstrates the first feasible and evaluable intervention with both statistically and clinically significant results that suggest potential for reducing safety risks among at-risk minority patients living with AD in future research.

Do feasibility studies contribute to, or avoid, waste in research?

PubMed Central

Hejdenberg, Jennie; Hinrichs-Krapels, Saba; Armstrong, David

2018-01-01

In the context of avoiding research waste, the conduct of a feasibility study before a clinical trial should reduce the risk that further resources will be committed to a trial that is likely to ‘fail’. However, there is little evidence indicating whether feasibility studies add to or reduce waste in research. Feasibility studies funded by the National Institute for Health Research’s (NIHR) Research for Patient Benefit (RfPB) programme were examined to determine how many had published their findings, how many had applied for further funding for a full trial and the timeframe in which both of these occurred. A total of 120 feasibility studies which had closed by May 2016 were identified and each Principal Investigator (PI) was sent a questionnaire of which 89 responses were received and deemed suitable for analysis. Based on self reported answers from the PIs a total of 57 feasibility studies were judged as feasible, 20 were judged not feasible and for 12 it was judged as uncertain whether a full trial was feasible. The RfPB programme had spent approximately £19.5m on the 89 feasibility studies of which 16 further studies had been subsequently funded to a total of £16.8m. The 20 feasibility studies which were judged as not feasible potentially saved up to approximately £20m of further research funding which would likely to have not completed successfully. The average RfPB feasibility study took 31 months (range 18 to 48) to complete and cost £219,048 (range £72,031 to £326,830) and the average full trial funded from an RfPB feasibility study took 42 months (range 26 to 55) to complete and cost £1,163,996 (range £321,403 to £2,099,813). The average timeframe of feasibility study and full trial was 72 months (range 56 to 91), however in addition to this time an average of 10 months (range -7 to 29) was taken between the end of the feasibility study and the application for the full trial, and a further average of 18 months (range 13 to 28) between the

Do feasibility studies contribute to, or avoid, waste in research?

PubMed

Morgan, Ben; Hejdenberg, Jennie; Hinrichs-Krapels, Saba; Armstrong, David

2018-01-01

In the context of avoiding research waste, the conduct of a feasibility study before a clinical trial should reduce the risk that further resources will be committed to a trial that is likely to 'fail'. However, there is little evidence indicating whether feasibility studies add to or reduce waste in research. Feasibility studies funded by the National Institute for Health Research's (NIHR) Research for Patient Benefit (RfPB) programme were examined to determine how many had published their findings, how many had applied for further funding for a full trial and the timeframe in which both of these occurred. A total of 120 feasibility studies which had closed by May 2016 were identified and each Principal Investigator (PI) was sent a questionnaire of which 89 responses were received and deemed suitable for analysis. Based on self reported answers from the PIs a total of 57 feasibility studies were judged as feasible, 20 were judged not feasible and for 12 it was judged as uncertain whether a full trial was feasible. The RfPB programme had spent approximately £19.5m on the 89 feasibility studies of which 16 further studies had been subsequently funded to a total of £16.8m. The 20 feasibility studies which were judged as not feasible potentially saved up to approximately £20m of further research funding which would likely to have not completed successfully. The average RfPB feasibility study took 31 months (range 18 to 48) to complete and cost £219,048 (range £72,031 to £326,830) and the average full trial funded from an RfPB feasibility study took 42 months (range 26 to 55) to complete and cost £1,163,996 (range £321,403 to £2,099,813). The average timeframe of feasibility study and full trial was 72 months (range 56 to 91), however in addition to this time an average of 10 months (range -7 to 29) was taken between the end of the feasibility study and the application for the full trial, and a further average of 18 months (range 13 to 28) between the

Efficacy, Safety, and Feasibility of the Morphine Microdose Method in Community-Based Clinics.

PubMed

Wilkes, Denise M; Orillosa, Susan J; Hustak, Erik C; Williams, Courtney G; Doulatram, Gulshan R; Solanki, Daneshvari R; Garcia, Eduardo A; Huang, Li-Yen M

2017-06-13

The goal of this study was to assess the success of the morphine microdose method in a community pain clinic setting by monitoring follow-up frequency, dose escalation, and monotherapy/polytherapy ratio. The morphine microdose method involves a pretrial reduction or elimination of systemic opioids followed by a period of abstinence. Intrathecal (IT) morphine is then started at doses of less than 0.2 mg per day. Systemic opioid abstinence is then continued after pump implant and IT morphine monotherapy. Retrospective review of medical records. Private and academic pain clinic practices. Chronic noncancer pain patients. We reviewed the charts of 60 patients who had completed a microdose regimen and had an IT pump implanted between June 11, 2008, and October 11, 2014. During IT therapy, dose change over time, pain scores, side effects, max dose, and duration were recorded. The majority of patients (35/60, 58%) were successfully managed solely on morphine microdose monotherapy. These patients did not require additional oral therapy. There was a significant reduction in mean pain scores, from 7.4 ± 0.32 before microdose therapy to 4.8 ± 0.3 after microdose therapy. Microdose therapy achieved analgesia, improved safety, and avoided systemic side effects. The safety of IT therapy was increased by using a lower concentration (2 mg/mL) and lower daily doses (<3 mg/d) of morphine. Furthermore, microdose therapy was feasible, safe, and cost-effective in the outpatient setting. 2017 American Academy of Pain Medicine. This work is written by US Government employees and is in the public domain in the US.

Feasibility and safety of endoscopic submucosal dissection for lower rectal tumors with hemorrhoids.

PubMed

Tanaka, Shinwa; Toyonaga, Takashi; Morita, Yoshinori; Hoshi, Namiko; Ishida, Tsukasa; Ohara, Yoshiko; Yoshizaki, Tetsuya; Kawara, Fumiaki; Umegaki, Eiji; Azuma, Takeshi

2016-07-21

To evaluate the feasibility and safety of endoscopic submucosal dissection (ESD) for lower rectal lesions with hemorrhoids. The outcome of ESD for 23 lesions with hemorrhoids (hemorrhoid group) was compared with that of 48 lesions without hemorrhoids extending to the dentate line (non-hemorrhoid group) during the same study period. Median operation times (ranges) in the hemorrhoid and non-hemorrhoid groups were 121 (51-390) and 130 (28-540) min. The en bloc resection rate and the curative resection rate in the hemorrhoid group were 96% and 83%, and they were 100% and 90% in the non-hemorrhoid group, respectively. In terms of adverse events, perforation and postoperative bleeding did not occur in both groups. In terms of the clinical course of hemorrhoids after ESD, the rate of complete recovery of hemorrhoids after ESD in lesions with resection of more than 90% was significantly higher than that in lesions with resection of less than 90%. ESD on lower rectal lesions with hemorrhoids could be performed safely, similarly to that on rectal lesions extending to the dentate line without hemorrhoids. In addition, all hemorrhoids after ESD improved to various degrees, depending on the resection range.

The efficacy and feasibility of aquatic physiotherapy for people with Parkinson's disease: a systematic review.

PubMed

Terrens, Aan Fleur; Soh, Sze-Ee; Morgan, Prue Elizabeth

2017-08-09

To critically evaluate the literature regarding the efficacy and feasibility of aquatic physiotherapy in people with Parkinson's disease. Relevant studies were identified through searches in nine health-related databases. Two independent reviewers assessed study quality using either the PEDro scale or a customised tool for safety and feasibility. Database searches yielded 88 articles, of which 10 met the inclusion criteria. Studies varied greatly in methodology, quality, interventions and outcome measures. Study quality was generally low in items reporting on safety precautions, adverse events, attrition, and adherence. Results suggest that aquatic physiotherapy may have a positive effect on motor symptoms, quality of life and balance. Aquatic physiotherapy may improve aspects of motor performance, quality of life and balance in people with Parkinson's disease, however, it remains unclear whether it is a safe and feasible treatment modality. The development of standardised outcome measures for people with Parkinson's disease (unified Parkinson's disease rating scale and Parkinson's disease questionnaire-39) would aid study comparability and validate study outcomes. As safety criteria was grossly underreported, guidelines for mandatory reporting of safety criteria are essential to make conclusions regarding the feasibility of aquatic physiotherapy for people with Parkinson's disease. Implications for Rehabilitation Aquatic physiotherapy may be a beneficial treatment modality for people with Parkinson's disease. A minimum data set that includes the unified Parkinson's disease rating scale and Parkinson's disease questionnaire 39 is required to aid future meta-analysis and to allow more definitive conclusions to be made regarding aquatic physiotherapy for people with Parkinson's disease. People with Parkinson's disease are a vulnerable population, where safety within an aquatic physiotherapy program needs to be well documented and addressed.

White Earth Biomass/Biogas Feasibility Study

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

Triplett, Michael

2015-03-12

The White Earth Nation examined the feasibility of cost savings and fossil energy reduction through the installation of biogas/biomass boiler at the tribal casino. The study rejected biogas options due to availability and site constraints, but found a favorable environment for technical and financial feasibility of installing a 5 MMBtu hot water boiler system to offset 60-70 percent of current fuel oil and propane usage.

Feasibility, safety, and economic implications of whey-recovered water in cleaning-in-place systems: A case study on water conservation for the dairy industry.

PubMed

Meneses, Yulie E; Flores, Rolando A

2016-05-01

Water scarcity is threatening food security and business growth in the United States. In the dairy sector, most of the water is used in cleaning applications; therefore, any attempt to support water conservation in these processes will have a considerable effect on the water footprint of dairy products. This study demonstrates the viability for recovering good quality water from whey, a highly pollutant cheese-making by-product, to be reused in cleaning-in-place systems. The results obtained in this study indicate that by using a combined ultrafiltration and reverse osmosis system, 47% of water can be recovered. This system generates protein and lactose concentrates, by-products that once spray-dried fulfill commercial standards for protein and lactose powders. The physicochemical and microbiological quality of the recovered permeate was also analyzed, suggesting suitable properties to be reused in the cleaning-in-place system without affecting the quality and safety of the product manufactured on the cleaned equipment. A cost analysis was conducted for 3 cheese manufacturing levels, considering an annual production of 1, 20, and 225 million liters of whey. Results indicate the feasibility of this intervention in the dairy industry, generating revenues of $0.18, $3.05, and $33.4 million per year, respectively. The findings provide scientific evidence to promote the safety of reuse of reconditioned water in food processing plants, contributing to building a culture of water conservation and sustainable production throughout the food supply chain. Copyright © 2016 American Dairy Science Association. Published by Elsevier Inc. All rights reserved.

Rochester rail link feasibility study

DOT National Transportation Integrated Search

2003-01-01

The purpose of this study is to determine the feasibility of connecting Minneapolis-St. Paul International Airport to Rochester International Airport with a high-speed rail line to move passengers and cargo. The primary goal of this study is to deter...

40 CFR 35.1605-8 - Diagnostic-feasibility study.

Code of Federal Regulations, 2011 CFR

2011-07-01

... 40 Protection of Environment 1 2011-07-01 2011-07-01 false Diagnostic-feasibility study. 35.1605-8... Freshwater Lakes § 35.1605-8 Diagnostic-feasibility study. A two-part study to determine a lake's current... the study includes gathering information and data to determine the limnological, morphological...

40 CFR 35.1605-8 - Diagnostic-feasibility study.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 40 Protection of Environment 1 2010-07-01 2010-07-01 false Diagnostic-feasibility study. 35.1605-8... Freshwater Lakes § 35.1605-8 Diagnostic-feasibility study. A two-part study to determine a lake's current... the study includes gathering information and data to determine the limnological, morphological...

Atmospheric rendezvous feasibility study

NASA Technical Reports Server (NTRS)

Schaezler, A. D.

1972-01-01

A study was carried out to determine the feasibility of using atmospheric rendezvous to increase the efficiency of space transportation and to determine the most effective implementation. It is concluded that atmospheric rendezvous is feasible and can be utilized in a space transportation system to reduce size of the orbiter vehicle, provide a powered landing with go-around capability for every mission, and achieve lateral range performance that exceeds requirements. A significantly lighter booster and reduced launch fuel requirements are additional benefits that can be realized with a system that includes a large subsonic airplane for recovery of the orbiter. Additional reduction in booster size is possible if the airplane is designed for recovery of the booster by towing. An airplane about the size of the C-5A is required.

Safety and feasibility of an exercise prescription approach to rehabilitation across the continuum of care for survivors of critical illness.

PubMed

Berney, Sue; Haines, Kimberley; Skinner, Elizabeth H; Denehy, Linda

2012-12-01

Survivors of critical illness can experience long-standing functional limitations that negatively affect their health-related quality of life. To date, no model of rehabilitation has demonstrated sustained improvements in physical function for survivors of critical illness beyond hospital discharge. The aims of this study were: (1) to describe a model of rehabilitation for survivors of critical illness, (2) to compare the model to local standard care, and (3) to report the safety and feasibility of the program. This was a cohort study. As part of a larger randomized controlled trial, 74 participants were randomly assigned, 5 days following admission to the intensive care unit (ICU), to a protocolized rehabilitation program that commenced in the ICU and continued on the acute care ward and for a further 8 weeks following hospital discharge as an outpatient program. Exercise training was prescribed based on quantitative outcome measures to achieve a physiological training response. During acute hospitalization, 60% of exercise sessions were able to be delivered. The most frequently occurring barriers to exercise were patient safety and patient refusal due to fatigue. Point prevalence data showed patients were mobilized more often and for longer periods compared with standard care. Outpatient classes were poorly attended, with only 41% of the patients completing more than 70% of outpatient classes. No adverse events occurred. Limitations included patient heterogeneity and delayed commencement of exercise in the ICU due to issues of consent and recruitment. Exercise training that commences in the ICU and continues through to an outpatient program is safe and feasible for survivors of critical illness. Models of care that maximize patient participation across the continuum of care warrant further investigation.

Nurses' experiences and perspectives on medication safety practices: an explorative qualitative study.

PubMed

Smeulers, Marian; Onderwater, Astrid T; van Zwieten, Myra C B; Vermeulen, Hester

2014-04-01

To explore nurses' experiences with and perspectives on preventing medication administration errors. Insight into nurses' experiences with and perspectives on preventing medication administration errors is important and can be utilised to tailor and implement safety practices. A qualitative interview study of 20 nurses in an academic medical centre was conducted between March and December of 2011. Three themes emerged from this study: (1) nurses' roles and responsibilities in medication safety: aside from safe preparation and administration, the clinical reasoning of nurses is essential for medication safety; (2) nurses' ability to work safely: knowledge of risks and nurses' work circumstances influence their ability to work safely; and (3) nurses' acceptance of safety practices: advantages, feasibility and appropriateness are important incentives for acceptance of a safety practice. Nurses' experiences coincide with the assumption that they are in a pre-eminent position to enable safe medication management; however, their ability to adequately perform this role depends on sufficient knowledge to assess the risks of medication administration and on the circumstances in which they work. Safe medication management requires a learning climate and professional practice environment that enables further development of professional nursing skills and knowledge. © 2014 John Wiley & Sons Ltd.

Novel Percutaneous Radiofrequency Ablation of Portal Vein Tumor Thrombus: Safety and Feasibility

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

Mizandari, Malkhaz; Ao, Guokun; Zhang Yaojun

2013-02-15

We report our experience of the safety of partial recanalization of the portal vein using a novel endovascular radiofrequency (RF) catheter for portal vein tumor thrombosis. Six patients with liver cancer and tumor thrombus in the portal vein underwent percutaneous intravascular radiofrequency ablation (RFA) using an endovascular bipolar RF device. A 0.035-inch guidewire was introduced into a tributary of the portal vein and through which a 5G guide catheter was introduced into the main portal vein. After manipulation of the guide catheter over the thrombus under digital subtraction angiography, the endovascular RF device was inserted and activated around the thrombus.more » There were no observed technique specific complications, such as hemorrhage, vessel perforation, or infection. Post-RFA portography showed partial recanalization of portal vein. RFA of portal vein tumor thrombus in patients with hepatocellular carcinoma is technically feasible and warrants further investigation to assess efficacy compared with current recanalization techniques.« less

Feasibility Study of Non-Destructive Techniques to Measure Corrosion in SAVY Containers

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

Davenport, Matthew Nicholas

2016-07-15

Stainless Steel SAVY containers are used to transport and store nuclear material. They are prone to interior corrosion in the presence of certain chemicals and a low-oxygen environment. SAVY containers also have relatively thin walls to reduce their weight, making their structural integrity more vulnerable to the effects of corrosion. A nondestructive evaluation system that finds and monitors corrosion within containers in use would improve safety conditions and preclude hazards. Non-destructive testing can determine whether oxidation or corrosion is occurring inside the SAVY containers, and there are a variety of non-destructive testing methods that may be viable. The feasibility studymore » described will objectively decide which method best fits the requirements of the facility and the problem. To improve efficiency, the containers cannot be opened during the non-destructive examination. The chosen technique should also be user-friendly and relatively quick to apply. It must also meet facility requirements regarding wireless technology and maintenance. A feasibility study is an objective search for a new technology or product to solve a particular problem. First, the design, technical, and facility feasibility requirements are chosen and ranked in order of importance. Then each technology considered is given a score based upon a standard ranking system. The technology with the highest total score is deemed the best fit for a certain application.« less

Feasibility Study for Battle Mountain Renewable Energy Park

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

Hill, Donna

The Feasibility Study for the Battle Mountain Renewable Energy Park project (“Feasibility Study”) will assess the feasibility, benefits and impacts of a 5 Mega Watt (MW) solar photovoltaic (PV) generating system (the “Solar Project” or “Energy Park”) on the Te-Moak Tribe of Western Shoshone Indians of Nevada Battle Mountain Colony in Battle Mountain, Nevada (NV). The Energy Park will provide power for export to utility off-takers and job training and employment for Tribal members and revenue for the Tribe. This Feasibility Study will be a collaborative effort between the Tribal government, consultants, Tribal members and stakeholders and will allow themore » Tribe to make informed decisions regarding the Solar Project.« less

Intra-discal injection of autologous, hypoxic cultured bone marrow-derived mesenchymal stem cells in five patients with chronic lower back pain: a long-term safety and feasibility study.

PubMed

Elabd, Christian; Centeno, Christopher J; Schultz, John R; Lutz, Gregory; Ichim, Thomas; Silva, Francisco J

2016-09-01

Chronic low back pain due to disc degeneration represents a major social and economic burden worldwide. The current standard of care is limited to symptomatic relief and no current approved therapy promotes disc regeneration. Bone marrow-derived mesenchymal stem cells (MSCs) are easily accessible and well characterized. These MSCs are multipotent and exhibit great tissue regenerative potential including bone, cartilage, and fibrous tissue regeneration. The use of this cell-based biologic for treating protruding disc herniation and/or intervertebral disc degeneration is a promising therapeutic strategy, due to their known regenerative, immuno-modulatory and anti-inflammatory properties. Five patients diagnosed with degenerative disc disease received an intra-discal injection of autologous, hypoxic cultured, bone marrow-derived mesenchymal stem cells (15.1-51.6 million cells) as part of a previous study. These patients were re-consented to participate in this study in order to assess long-term safety and feasibility of intra-discal injection of autologous, hypoxic cultured, bone marrow-derived mesenchymal stem cells 4-6 years post mesenchymal stem cell infusion. The follow-up study consisted of a physical examination, a low back MRI, and a quality of life questionnaire. Patients' lower back MRI showed absence of neoplasms or abnormalities surrounding the treated region. Based on the physical examination and the quality of life questionnaire, no adverse events were reported due to the procedure or to the stem cell treatment 4-6 years post autologous, hypoxic cultured mesenchymal stem cell infusion. All patients self-reported overall improvement, as well as improvement in strength, post stem cell treatment, and four out of five patients reported improvement in mobility. This early human clinical data suggests the safety and feasibility of the clinical use of hypoxic cultured bone marrow-derived mesenchymal stem cells for the treatment of lower back pain due to

Dobutamine stress MRI. Part I. Safety and feasibility of dobutamine cardiovascular magnetic resonance in patients suspected of myocardial ischemia.

PubMed

Kuijpers, Dirkjan; Janssen, Caroline H C; van Dijkman, Paul R M; Oudkerk, Matthijs

2004-10-01

The aim of the study was to evaluate safety and feasibility of dobutamine cardiovascular magnetic resonance (CMR) in patients with proven or suspected coronary artery disease. Dobutamine CMR was evaluated retrospectively in 400 consecutive patients with suspicion of myocardial ischemia. Dobutamine was infused using an incremental protocol up to 40 microg/kg body weight per minute. All anti-anginal medication was stopped 4 days before the CMR study and infusion time of dobutamine was 6 min per stage. Hemodynamic data, CMR findings and side effects were reported. Patients with contraindications to CMR (metallic implants and claustrophobia) were excluded from analysis. Dobutamine CMR was successfully performed in 355 (89%) patients. Forty-five (11%) patients could not be investigated adequately because of non-cardiac side effects in 29 (7%) and cardiac side effects in 16 (4%) patients. Hypotension (1.5%) and arrhythmias (1%) were the most frequent cardiac side effects. One patient developed a severe complication (ventricular fibrillation) at the end of the study. There were no myocardial infarctions or fatal complications of the stress test. The most frequent non-cardiac side effects were nausea, vomiting and claustrophobia. Age >70 years, prior myocardial infarction and rest wall motion abnormalities showed no significant differences with side effects (P>0.05). Dobutamine CMR is safe and feasible in patients with suspicion of myocardial ischemia. Copyright 2004 Springer-Verlag

Robotic selective neck dissection using a gasless postauricular facelift approach for early head and neck cancer: technical feasibility and safety.

PubMed

Tae, Kyung; Ji, Yong Bae; Song, Chang Myeon; Min, Hyun Jung; Kim, Kyung Rae; Park, Chul Won

2013-03-01

Abstract Background: Scarless and minimally invasive surgery is becoming popular in the head and neck area. We have developed a new robotic selective neck dissection procedure for head and neck squamous cell carcinoma (HNSCC) to avoid a long visible lateral neck scar. Here we report on the technical feasibility and safety of our procedure. We prospectively analyzed 4 patients with early HNSCC who underwent transoral robotic surgery (TORS) and concomitant robotic selective neck dissection via a gasless postauricular facelift approach using the da Vinci(®) Surgical System (Intuitive Surgical Inc., Sunnyvale, CA). Of these patients, 3 were male, and 1 was female. The mean age was 59.0±8.8 years. All patients had tongue cancer, with a clinically negative neck. Three patients were T1, and 1 patient was T2. All patients underwent partial glossectomy by TORS and elective robotic selective neck dissection including levels I, II, and III. The robotic selective neck dissection procedure was completed successfully in all patients. The mean operative time was 276±48 minutes. The mean number of lymph nodes removed was 19.3±7.3. Postoperative hematoma and transient marginal nerve palsy occurred in 1 patient each. Cosmetic satisfaction was excellent in all patients. Preliminary results indicate that robotic selective neck dissection via a gasless postauricular facelift approach is feasible and safe and allows for excellent postoperative cosmesis. Further studies are necessary to determine the oncologic safety and surgical completeness of this procedure compared with conventional neck dissection.

Effect of information feedback on training standing up following stroke: a pilot feasibility study.

PubMed

Stanton, Rosalyn; Ada, Louise; Dean, Catherine M; Preston, Elisabeth

2016-12-01

The ability to stand up is reduced following stroke. Traditional biofeedback is effective in improving the performance of lower limb activities. The aim of this study was to investigate the feasibility of and potential for information feedback from a simple inexpensive device to improve the ability to stand up from a chair in people following stroke. A single-group study with pre-post measures design was used. Twenty people with hemiplegic stroke in inpatient rehabilitation received 10 sessions over 2 weeks of information feedback about foot placement during training of standing up. Progression involved increasing repetitions, increasing difficulty and fading feedback. Feasibility was determined by adherence, time taken, acceptability and safety. Clinical outcomes were the time taken to stand up, quality and foot position measured using the 5-Times-Sit-To-Stand-Test and carryover into daily activities measured by covert observation. The study was feasible with 97% of sessions completed, taking 19 (SD 6) to 25 (SD 10) minutes. Participants understood (4.6/5), found useful (4.6/5), challenging (4.4/5) and would recommend (4.7/5) the training. The time to stand up 5 times decreased by 24 (95% CI -48 to -1) s, and the quality of standing improved by 1.0/10.0 (95% CI 0.2 to 1.8). Carryover of the correct foot placement occurred to real life, with the beginning foot position correct 2.1/3.0 (95% CI 1.6 to 2.6) and end foot position correct 1.8/3.0 (95% CI 1.2 to 2.4) occasions. The training is feasible and has the potential to improve the ability to stand up.

Feasibility of a Trial on Improvisational Music Therapy for Children with Autism Spectrum Disorder.

PubMed

Geretsegger, Monika; Holck, Ulla; Bieleninik, Łucja; Gold, Christian

2016-01-01

To conduct generalizable, rigorously designed, adequately powered trials investigating music therapy and other complex interventions, it is essential that study procedures are feasible and acceptable for participants. To date, only limited evidence on feasibility of trial designs and strategies to facilitate study implementation is available in the music therapy literature. Using data from a subsample of a multi-center RCT on improvisational music therapy (IMT) for autism spectrum disorder (ASD), this study aims to evaluate feasibility of study procedures, evaluate safety, document concomitant treatment, and report consistency of individuals' trends over time in chosen outcome measures. Children with ASD aged between 4 years, 0 months, and 6 years, 11 months, were randomly assigned to one of three conditions: one (low intensity) vs. three weekly IMT sessions (high intensity) for five months vs. standard care. Feasibility was evaluated by examining recruitment, implementation of study conditions, assessment procedures, blinding, and retention; we also evaluated safety, concomitant treatment, and consistency of changes in standardized scales completed by blinded assessors and parents before and 5 months after randomization. Within this subsample (n = 15), recruitment rates, session attendance in the high-intensity condition, and consistency between outcome measures were lower than expected. Session attendance in the low-intensity and control conditions, treatment fidelity, measurement completion, blinding, retention, and safety met a priori thresholds for feasibility. By discussing strategies to improve recruitment and to minimize potential burden on study participants, referrers, and researchers, this study helps build knowledge about designing and implementing trials successfully. © the American Music Therapy Association 2016. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

Safety and feasibility of liver resection with continued antiplatelet therapy using aspirin.

PubMed

Monden, Kazuteru; Sadamori, Hiroshi; Hioki, Masayoshi; Ohno, Satoshi; Saneto, Hiromi; Ueki, Toru; Yabushita, Kazuhisa; Ono, Kazumi; Sakaguchi, Kousaku; Takakura, Norihisa

2017-07-01

Aspirin is widely used for the secondary prevention of ischemic stroke and cardiovascular disease. Perioperative aspirin may decrease thrombotic morbidity, but may also increase hemorrhagic morbidity. In particular, liver resection carries risks of bleeding, leading to higher risks of hemorrhagic morbidity. Our institution has continued aspirin therapy perioperatively in patients undergoing liver resection. This study examined the safety and feasibility of liver resection while continuing aspirin. We retrospectively evaluated 378 patients who underwent liver resection between January 2010 and January 2016. Patients were grouped according to preoperative aspirin prescription: patients with aspirin therapy (aspirin users, n = 31); and patients without use of aspirin (aspirin non-users, n = 347). Aspirin users were significantly older (P < 0.001), with a higher proportion of males (P < 0.001) and higher frequencies of hypertension (P  = 0.004) and diabetes mellitus (P < 0.001). No significant differences were observed in intraoperative parameters. Although the frequency of major morbidity tended to be higher among aspirin users than among aspirin non-users, no significant difference was identified. No postoperative hemorrhage was seen among aspirin users. Liver resection can be safely performed while continuing aspirin therapy without increasing hemorrhagic morbidity. Our results suggest that interruption of aspirin therapy is unnecessary for patients undergoing liver resection. © 2017 Japanese Society of Hepato-Biliary-Pancreatic Surgery.

Percutaneous intrapericardial echocardiography during catheter ablation: a feasibility study.

PubMed

Horowitz, Barbara Natterson; Vaseghi, Marmar; Mahajan, Aman; Cesario, David A; Buch, Eric; Valderrábano, Miguel; Boyle, Noel G; Ellenbogen, Kenneth A; Shivkumar, Kalyanam

2006-11-01

Percutaneous pericardial access, epicardial mapping, and ablation have been used successfully for catheter ablation procedures. The purpose of this study was to evaluate the safety and feasibility of closed-chest direct epicardial ultrasound imaging for aiding cardiac catheter ablation procedures. An intracardiac ultrasound catheter was used for closed-chest epicardial imaging of the heart in 10 patients undergoing percutaneous epicardial access for catheter ablation. All patients underwent concomitant intracardiac echocardiography and preprocedural transesophageal echocardiography. Using a double-wire technique, two sheaths were placed in the pericardium, and a phased-array ultrasound catheter was manipulated within the pericardial sinuses for imaging. Multiple images from varying angles were obtained for catheter navigation. Notably, image stability was excellent, and structures such as the left atrial appendage were seen in great detail. No complications resulting from use of the ultrasound catheter in the pericardium occurred, and no restriction of movement due to the presence of the additional catheter in the pericardial space was observed. Wall motion was correlated to voltage maps in five patients and showed that areas of scars correlated with wall-motion abnormalities. Normal wall-motion score correlated to sensed signals of 4.2 +/- 0.3 mV (normal myocardium >1.5 mV), and scores >1 correlated to areas with signals <0.5 mV in that territory). Intrapericardial imaging using an ultrasound catheter is feasible and safe and has the potential to provide additional valuable information for complex ablation procedures.

Feasibility, safety, and effectiveness of transcranial direct current stimulation for decreasing post-ERCP pain: a randomized, sham-controlled, pilot study.

PubMed

Borckardt, Jeffrey J; Romagnuolo, Joseph; Reeves, Scott T; Madan, Alok; Frohman, Heather; Beam, Will; George, Mark S

2011-06-01

Emerging evidence shows that transcranial direct current stimulation (tDCS), a minimally invasive brain stimulation technique, has analgesic effects in chronic pain patients and in healthy volunteers with experimental pain. No studies have examined the analgesic effects of tDCS immediately after surgical/endoscopic procedures. Endoscopy investigating abdominal pain, especially ERCP, can cause significant postprocedural pain. To test the feasibility, efficacy, and safety of tDCS on post-ERCP pain and analgesia use. Randomized, sham-controlled, pilot study. Tertiary-care medical center. This study involved 21 patients who were hospitalized overnight for ERCP for unexplained right upper quadrant pain. Twenty minutes of real 2.0 mA tDCS or sham (anode over left prefrontal cortex; cathode over gut-representation of right sensory cortex) immediately after ERCP. Pain (visual analogue scale, McGill pain questionnaire, brief pain inventory), patient-controlled analgesia use, adverse events. Real tDCS was associated with 22% less total hydromorphone use, versus sham. The slope of the cumulative patient-controlled analgesia usage curve was significantly steeper in the sham tDCS group (F [2,13] = 15.96; P = .0003). Real tDCS patients reported significantly less pain interference with sleep (t [17] = 3.70; P = .002) and less throbbing pain (t [16] = 2.37; P = .03). Visual analogue scale pain and mood scores (4 hours post-ERCP) suggested a nonsignificant advantage for real tDCS, despite less hydromorphone use. Side effects of tDCS were limited to mild, self-limited tingling, itching, and stinging under electrodes. Small sample size, variability in chronic pain, and chronic opioid use. In this pilot study, tDCS appears to be safe, has minimal side effects, and may reduce postprocedural analgesia requirements and subjective pain ratings. Future studies appear warranted. Copyright © 2011 American Society for Gastrointestinal Endoscopy. Published by Mosby, Inc. All rights reserved.

Foot-controlled robotic-enabled endoscope holder for endoscopic sinus surgery: A cadaveric feasibility study.

PubMed

Chan, Jason Y K; Leung, Iris; Navarro-Alarcon, David; Lin, Weiyang; Li, Peng; Lee, Dennis L Y; Liu, Yun-hui; Tong, Michael C F

2016-03-01

To evaluate the feasibility of a unique prototype foot-controlled robotic-enabled endoscope holder (FREE) in functional endoscopic sinus surgery. Cadaveric study. Using human cadavers, we investigated the feasibility, advantages, and disadvantages of the robotic endoscope holder in performing endoscopic sinus surgery with two hands in five cadaver heads, mimicking a single nostril three-handed technique. The FREE robot is relatively easy to use. Setup was quick, taking less than 3 minutes from docking the robot at the head of the bed to visualizing the middle meatus. The unit is also relatively small, takes up little space, and currently has four degrees of freedom. The learning curve for using the foot control was short. The use of both hands was not hindered by the presence of the endoscope in the nasal cavity. The tremor filtration also aided in the smooth movement of the endoscope, with minimal collisions. The FREE endoscope holder in an ex-vivo cadaver test corroborated the feasibility of the robotic prototype, which allows for a two-handed approach to surgery equal to a single nostril three-handed technique without the holder that may reduce operating time. Further studies will be needed to evaluate its safety profile and use in other areas of endoscopic surgery. NA. Laryngoscope, 126:566-569, 2016. © 2015 The American Laryngological, Rhinological and Otological Society, Inc.

Feasibility study of shared-ride auto transit. Final report

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

Kocur, G.; Zaelke, D.; Neumann, L.

1977-09-01

The report examines the feasibility of the implementation of shared-ride auto transit (SRAT), which is an innovative approach for increasing auto occupancy in rural and urban areas. The report focuses on operational concepts, potential usage, legal and regulatory issues, and institutional issues. Formulation of the SRAT concept was motivated by several concerns, such as: (1) energy conservation; (2) transit service to areas unable to economically justify conventional transit services, and to travel disadvantaged groups; (3) transit service replacement to achieve greater efficiency and to reduce transit deficits; (4) provision of inexpensive transit service; and (5) the increase of safety andmore » reliability of hitchhiking. Four case study sites (Boulder, Colorado; Boston, Massachusetts; Portland, Oregon; and Tidewater, Virginia), were used to identify the specific institutional issues likely to impact SRAT implementation for that site, and to identify the opportunities for designing, implementing and operating SRAT in a variety of institutional settings.« less

Consumer behaviour survey for assessing exposure from consumer products: a feasibility study.

PubMed

Schneider, Klaus; Recke, Selina; Kaiser, Eva; Götte, Sebastian; Berkefeld, Henrike; Lässig, Juliane; Rüdiger, Thomas; Lindtner, Oliver; Oltmanns, Jan

2018-05-23

Evaluating chemical exposures from consumer products is an essential part of chemical safety assessments under REACH and may also be important to demonstrate compliance with consumer product legislation. Modelling of consumer exposure needs input information on the substance (e.g. vapour pressure), the product(s) containing the substance (e.g. concentration) and on consumer behaviour (e.g. use frequency and amount of product used). This feasibility study in Germany investigated methods for conducting a consumer survey in order to identify and retrieve information on frequency, duration, use amounts and use conditions for six example product types (four mixtures, two articles): hand dishwashing liquid, cockpit spray, fillers, paints and lacquers, shoes made of rubber or plastic, and ball-pens/pencils. Retrospective questionnaire methods (Consumer Product Questionnaire (CPQ), and Recall-Foresight Questionnaire (RFQ)) as well as protocol methods (written reporting by participants and video documentation) were used. A combination of retrospective questionnaire and written protocol methods was identified to provide valid information in a resource-efficient way. Relevant information, which can readily be used in exposure modelling, was obtained for all parameters and product types investigated. Based on the observations in this feasibility study, recommendations are given for designing a large consumer survey.

Feasibility and safety of early lower limb robot-assisted training in sub-acute stroke patients: a pilot study.

PubMed

Gandolfi, Marialuisa; Geroin, Christian; Tomelleri, Christopher; Maddalena, Isacco; Kirilova Dimitrova, Eleonora; Picelli, Alessandro; Smania, Nicola; Waldner, Andreas

2017-12-01

So far, the development of robotic devices for the early lower limb mobilization in the sub-acute phase after stroke has received limited attention. To explore the feasibility of a newly robotic-stationary gait training in sub-acute stroke patients. To report the training effects on lower limb function and muscle activation. A pilot study. Rehabilitation ward. Two sub-acute stroke inpatients and ten age-matched healthy controls were enrolled. Healthy controls served as normative data. Patients underwent 10 robot-assisted training sessions (20 minutes, 5 days/week) in alternating stepping movements (500 repetitions/session) on a hospital bed in addition to conventional rehabilitation. Feasibility outcome measures were compliance, physiotherapist time, and responses to self-report questionnaires. Efficacy outcomes were bilateral lower limb muscle activation pattern as measured by surface electromyography (sEMG), Motricity Index (MI), Medical Research Council (MRC) grade, and Ashworth Scale (AS) scores before and after training. No adverse events occurred. No significant differences in sEMG activity between patients and healthy controls were observed. Post-training improvement in MI and MRC scores, but no significant changes in AS scores, were recorded. Post-treatment sEMG analysis of muscle activation patterns showed a significant delay in rectus femoris offset (P=0.02) and prolonged duration of biceps femoris (P=0.04) compared to pretreatment. The robot-assisted training with our device was feasible and safe. It induced physiological muscle activations pattern in both stroke patients and healthy controls. Full-scale studies are needed to explore its potential role in post-stroke recovery. This robotic device may enrich early rehabilitation in subacute stroke patients by inducing physiological muscle activation patterns. Future studies are warranted to evaluate its effects on promoting restorative mechanisms involved in lower limb recovery after stroke.

Feasibility and safety of endoscopic submucosal dissection for lower rectal tumors with hemorrhoids

PubMed Central

Tanaka, Shinwa; Toyonaga, Takashi; Morita, Yoshinori; Hoshi, Namiko; Ishida, Tsukasa; Ohara, Yoshiko; Yoshizaki, Tetsuya; Kawara, Fumiaki; Umegaki, Eiji; Azuma, Takeshi

2016-01-01

AIM: To evaluate the feasibility and safety of endoscopic submucosal dissection (ESD) for lower rectal lesions with hemorrhoids. METHODS: The outcome of ESD for 23 lesions with hemorrhoids (hemorrhoid group) was compared with that of 48 lesions without hemorrhoids extending to the dentate line (non-hemorrhoid group) during the same study period. RESULTS: Median operation times (ranges) in the hemorrhoid and non-hemorrhoid groups were 121 (51-390) and 130 (28-540) min. The en bloc resection rate and the curative resection rate in the hemorrhoid group were 96% and 83%, and they were 100% and 90% in the non-hemorrhoid group, respectively. In terms of adverse events, perforation and postoperative bleeding did not occur in both groups. In terms of the clinical course of hemorrhoids after ESD, the rate of complete recovery of hemorrhoids after ESD in lesions with resection of more than 90% was significantly higher than that in lesions with resection of less than 90%. CONCLUSION: ESD on lower rectal lesions with hemorrhoids could be performed safely, similarly to that on rectal lesions extending to the dentate line without hemorrhoids. In addition, all hemorrhoids after ESD improved to various degrees, depending on the resection range. PMID:27468216

Feasibility and Pilot Studies in Palliative Care Research: A Systematic Review.

PubMed

Jones, Terry A; Olds, Timothy S; Currow, David C; Williams, Marie T

2017-07-01

Feasibility and pilot study designs are common in palliative care research. Finding standard guidelines on the structure and reporting of these study types is difficult. In feasibility and pilot studies in palliative care research, to determine 1) how commonly a priori feasibility are criteria reported and whether results are subsequently reported against these criteria? and 2) how commonly are participants' views on acceptability of burden of the study protocol assessed? Four databases (OVID Medline, EMBASE, CINAHL, and PubMed via caresearch.com.au.) were searched. Search terms included palliative care, terminal care, advance care planning, hospice, pilot, feasibility, with a publication date between January 1, 2012 and December 31, 2013. Articles were selected and appraised by two independent reviewers. Fifty-six feasibility and/or pilot studies were included in this review. Only three studies had clear a priori criteria to measure success. Sixteen studies reported participant acceptability or burden with measures. Forty-eight studies concluded feasibility. The terms "feasibility" and "pilot" are used synonymously in palliative care research when describing studies that test for feasibility. Few studies in palliative care research outline clear criteria for success. The assessment of participant acceptability and burden is uncommon. A gold standard for feasibility study design in palliative care research that includes both clear criteria for success and testing of the study protocol for participant acceptability and burden is needed. Such a standard would assist with consistency in the design, conduct and reporting of feasibility and pilot studies. Copyright © 2017 American Academy of Hospice and Palliative Medicine. Published by Elsevier Inc. All rights reserved.

Safety and Feasibility of a Ketamine Package to Support Emergency and Essential Surgery in Kenya when No Anesthetist is Available: An Analysis of 1216 Consecutive Operative Procedures.

PubMed

Burke, Thomas F; Suarez, Sebastian; Sessler, Daniel I; Senay, Ayla; Yusufali, Taha; Masaki, Charles; Guha, Moytrayee; Rogo, Debora; Jani, Pankaj; Nelson, Brett D; Rogo, Khama

2017-12-01

Lack of access to emergency and essential surgery is widespread in low- and middle-income countries. Scarce anesthesia services contribute to this unmet need. The aim of this study was to evaluate the safety and feasibility of the Every Second Matters for Emergency and Essential Surgery-Ketamine (ESM-Ketamine) package for emergency and essential procedures when no anesthetist was available. From November 2013 to September 2017, the ESM-Ketamine package was used for patients requiring emergency or life-improving surgeries in fifteen selected facilities across Kenya when no anesthetist was available. A mixed-methods approach was used to assess safety and feasibility of the ESM-Ketamine package, including demand, acceptability, and practicality. The primary outcome was ketamine-related adverse events. Key-informant interviews captured perceptions of providers, hospital administrators, and surgeons/proceduralists. Non-anesthetist mid-level providers used ESM-Ketamine for 1216 surgical procedures across the fifteen study facilities. The median ketamine dose was 2.1 mg/kg. Brief (<30 s) oxygen desaturations occurred in 39 patients (3%), and prolonged (>30 s) oxygen desaturations occurred in seven patients (0.6%). There were 157 (13%) reported cases of hallucinations and agitation which were treated with diazepam. All patients recovered uneventfully, and no ketamine-related deaths were reported. Twenty-seven key-informant interviews showed strong support for the program with four main themes: financial considerations, provision of services, staff impact, and scaling considerations. The ESM-Ketamine package appears safe and feasible and is capable of expanding access to emergency and essential surgeries in rural Kenya when no anesthetist is available.

Safety and feasibility of STAT RAD: Improvement of a novel rapid tomotherapy-based radiation therapy workflow by failure mode and effects analysis.

PubMed

Jones, Ryan T; Handsfield, Lydia; Read, Paul W; Wilson, David D; Van Ausdal, Ray; Schlesinger, David J; Siebers, Jeffrey V; Chen, Quan

2015-01-01

The clinical challenge of radiation therapy (RT) for painful bone metastases requires clinicians to consider both treatment efficacy and patient prognosis when selecting a radiation therapy regimen. The traditional RT workflow requires several weeks for common palliative RT schedules of 30 Gy in 10 fractions or 20 Gy in 5 fractions. At our institution, we have created a new RT workflow termed "STAT RAD" that allows clinicians to perform computed tomographic (CT) simulation, planning, and highly conformal single fraction treatment delivery within 2 hours. In this study, we evaluate the safety and feasibility of the STAT RAD workflow. A failure mode and effects analysis (FMEA) was performed on the STAT RAD workflow, including development of a process map, identification of potential failure modes, description of the cause and effect, temporal occurrence, and team member involvement in each failure mode, and examination of existing safety controls. A risk probability number (RPN) was calculated for each failure mode. As necessary, workflow adjustments were then made to safeguard failure modes of significant RPN values. After workflow alterations, RPN numbers were again recomputed. A total of 72 potential failure modes were identified in the pre-FMEA STAT RAD workflow, of which 22 met the RPN threshold for clinical significance. Workflow adjustments included the addition of a team member checklist, changing simulation from megavoltage CT to kilovoltage CT, alteration of patient-specific quality assurance testing, and allocating increased time for critical workflow steps. After these modifications, only 1 failure mode maintained RPN significance; patient motion after alignment or during treatment. Performing the FMEA for the STAT RAD workflow before clinical implementation has significantly strengthened the safety and feasibility of STAT RAD. The FMEA proved a valuable evaluation tool, identifying potential problem areas so that we could create a safer workflow

Open-type ferry safety system design for using LNG fuel

NASA Astrophysics Data System (ADS)

Pagonis, D. N.; Livanos, G.; Theotokatos, G.; Peppa, S.; Themelis, N.

2016-12-01

In this feasibility study, we investigate the viability of using Liquefied Natural Gas (LNG) fuel in an open type Ro-Ro passenger ferry and the associated potential challenges with regard to the vessel safety systems. We recommend an appropriate methodology for converting existing ships to run on LNG fuel, discuss all the necessary modifications to the ship's safety systems, and also evaluate the relevant ship evacuation procedures. We outline the basic requirements with which the ship already complies for each safety system and analyze the additional restrictions that must be taken into consideration for the use of LNG fuel. Appropriate actions are recommended. Furthermore, we carry out a hazard identification study. Overall, we clearly demonstrate the technical feasibility of the investigated scenario. Minimal modifications to the ship's safety systems are required to comply with existing safety rules for this specific type of ship.

Home-based hand rehabilitation with a robotic glove in hemiplegic patients after stroke: a pilot feasibility study.

PubMed

Bernocchi, Palmira; Mulè, Chiara; Vanoglio, Fabio; Taveggia, Giovanni; Luisa, Alberto; Scalvini, Simonetta

2018-03-01

To evaluate the feasibility and safety of home rehabilitation of the hand using a robotic glove, and, in addition, its effectiveness, in hemiplegic patients after stroke. In this non-randomized pilot study, 21 hemiplegic stroke patients (Ashworth spasticity index ≤ 3) were prescribed, after in-hospital rehabilitation, a 2-month home-program of intensive hand training using the Gloreha Lite glove that provides computer-controlled passive mobilization of the fingers. Feasibility was measured by: number of patients who completed the home-program, minutes of exercise and number of sessions/patient performed. Safety was assessed by: hand pain with a visual analog scale (VAS), Ashworth spasticity index for finger flexors, opponents of the thumb and wrist flexors, and hand edema (circumference of forearm, wrist and fingers), measured at start (T0) and end (T1) of rehabilitation. Hand motor function (Motricity Index, MI), fine manual dexterity (Nine Hole Peg Test, NHPT) and strength (Grip test) were also measured at T0 and T1. Patients performed, over a mean period 56 (49-63) days, a total of 1699 (1353-2045) min/patient of exercise with Gloreha Lite, 5.1 (4.3-5.8) days/week. Seventeen patients (81%) completed the full program. The mean VAS score of hand pain, Ashworth spasticity index and hand edema did not change significantly at T1 compared to T0. The MI, NHPT and Grip test improved significantly (p = 0.0020, 0.0156 and 0.0024, respectively) compared to baseline. Gloreha Lite is feasible and safe for use in home rehabilitation. The efficacy data show a therapeutic effect which need to be confirmed by a randomized controlled study.

Balloon dilation of the cartilaginous portion of the eustachian tube: initial safety and feasibility analysis in a cadaver model.

PubMed

Poe, Dennis S; Hanna, Bassem Matta Nashed

2011-01-01

Balloon catheter dilation of diseased sinus ostia has recently demonstrated efficacy and safety in the treatment of chronic sinus disease with 2 years of follow-up. Similar to sinus surgery, initial studies of partial resection of inflamed mucosa from within the cartilaginous eustachian tube (ET) have demonstrated efficacy and safety in the treatment of medically refractory otitis media with effusion. Therefore, balloon dilation of the cartilaginous ET was investigated as a possible treatment modality for otitis media. A protocol for sinus balloon catheter dilation was evaluated in each of the cartilaginous ETs in 8 fresh human cadaver heads. Computed tomographic scans and detailed endoscopic inspections with video or photographic documentation were performed pre- and posttreatment, and gross anatomical dissections were done to analyze the effects of treatment and to look for evidence of undesired injury. Catheters successfully dilated all cartilaginous ETs without any significant injuries. There were no bony or cartilaginous fractures, and 3 specimens showed minor mucosal tears in the anterolateral or inferior walls. Volumetric measurements of the cartilaginous ET lumens showed a change from an average of 0.16 to 0.49 cm(3) (SD, 0.12), representing an average increase of 357% (range, 20-965%). Balloon catheter dilation of the nasopharyngeal orifice of the ET was shown to be feasible and without evidence of untoward injury. A significant increase in volume of the cartilaginous ET was achieved. A clinical study is now indicated to determine whether balloon dilation will demonstrate lasting benefits and safety in the treatment of otitis media. Copyright © 2011 Elsevier Inc. All rights reserved.

Transoesophageal spinal cord stimulation for motor-evoked potentials monitoring: feasibility, safety and stability.

PubMed

Tsuda, Kazumasa; Shiiya, Norihiko; Takahashi, Daisuke; Ohkura, Kazuhiro; Yamashita, Katsushi; Kando, Yumi

2015-08-01

Specificity of transcranial motor-evoked potentials (MEPs) is low because amplitude fluctuation is common, which seems due to several technical and fundamental reasons including difficulty in electrodes positioning and fixation for transcranial stimulation and susceptibility to anaesthesia. This study aimed to investigate the feasibility, safety and stability of our novel technique of transoesophageal spinal cord stimulation to improve the stability of MEPs. Ten anaesthetized adult beagle dogs were used. Transoesophageal stimulation was performed between the oesophageal luminal surface electrode (cathode) and a subcutaneous needle electrode (anode) at the fourth to fifth thoracic vertebra level. Stimulation was achieved with a train of five pulses delivered at 2.0-ms intervals. Compound muscle action potentials were recorded from four limbs and external anal sphincter muscles. Stability to anaesthetic agents was tested at varying speeds of propofol and remifentanil, and effects of varying concentration of sevoflurane inhalation were also evaluated. Transoesophageal MEPs could be recorded without difficulty in all dogs. Fluoroscopic evaluation showed that electrodes misalignment up to 5 cm cranially or caudally could be tolerated. Stimulus intensity to achieve maximum amplitude of hindlimb muscle potentials on both sides was significantly lower by transoesophageal stimulation than by transcranial stimulation (383 ± 41 vs 533 ± 121 V, P = 0.02) and had less interindividual variability. Latency of transoesophageal MEPs was shorter than that of transcranial MEPs at every recording point. No arrhythmia was provoked during stimulation. Animals that were allowed to recover showed no neurological abnormality. In the two sacrificed animals, the explanted oesophagus showed no mucosal injury. Stability to varying dose of anaesthetic agents was similar between transoesophageal and transcranial stimulation, except for the potentials of forelimbs by transoesophageal

Safety and feasibility of transcranial direct current stimulation (tDCS) combined with sensorimotor retraining in chronic low back pain: a protocol for a pilot randomised controlled trial.

PubMed

Ouellette, Adam Louis; Liston, Matthew B; Chang, Wei-Ju; Walton, David M; Wand, Benedict Martin; Schabrun, Siobhan M

2017-08-21

Chronic low back pain (LBP) is a common and costly health problem yet current treatments demonstrate at best, small effects. The concurrent application of treatments with synergistic clinical and mechanistic effects may improve outcomes in chronic LBP. This pilot trial aims to (1) determine the feasibility, safety and perceived patient response to a combined transcranial direct current stimulation (tDCS) and sensorimotor retraining intervention in chronic LBP and (2) provide data to support a sample size calculation for a fully powered trial should trends of effectiveness be present. A pilot randomised, assessor and participant-blind, sham-controlled trial will be conducted. Eighty participants with chronic LBP will be randomly allocated to receive either (1) active tDCS + sensorimotor retraining or (2) sham tDCS + sensorimotor retraining. tDCS (active or sham) will be applied to the primary motor cortex for 20 min immediately prior to 60 min of supervised sensorimotor retraining twice per week for 10 weeks. Participants in both groups will complete home exercises three times per week. Feasibility, safety, pain, disability and pain system function will be assessed immediately before and after the 10-week intervention. Analysis of feasibility and safety will be performed using descriptive statistics. Statistical analyses will be conducted based on intention-to-treat and per protocol and will be used to determine trends for effectiveness. Ethical approval has been gained from the institutional human research ethics committee (H10184). Written informed consent will be provided by all participants. Results from this pilot study will be submitted for publication in peer-reviewed journals. ACTRN12616000624482. © 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.

Pawnee-Divernon Educational Feasibility Study.

ERIC Educational Resources Information Center

Myers, Dean L., Ed.; And Others

The feasibility study concerns itself with the possible school district reorganization for the Pawnee and Divernon School Districts. Citizens' committees, boards of education, administration, and teachers provided consultant information about their schools. The evaluation committees, comprised of citizens from the Pawnee and Divernon School…

Microwave Sanitization of Color Additives Used in Cosmetics: Feasibility Study

PubMed Central

Jasnow, S. B.; Smith, J. L.

1975-01-01

Microwave exposure has been explored as a method of microbiologically sanitizing color additives used in cosmetic products. Selected microbiologically unacceptable cosmetic color additives, D&C red no. 7 Ca lake (certified synthetic organic color), carmine (natural organic color not subject to certification), and chromium hydroxide green (inorganic color not subject to certification), were submitted to microwave exposure. Gram-negative bacteria were eliminated, as verified by enrichment procedures, and levels of gram-positive bacteria were reduced. Generally, analytical and dermal safety studies indicated no significant alterations in physical, chemical, and toxicological properties of the colors. Sanitization was also successfully performed on other colors (D&C red no. 9 Ba lake, D&C red no. 12 Ba lake, D&C green no. 5, and FD&C red no. 4); initial physical and chemical tests were satisfactory. Results indicated that this method of sanitization is feasible and warrants further investigation. PMID:1164010

Applicability and feasibility of systematic review for performing evidence-based risk assessment in food and feed safety.

PubMed

Aiassa, E; Higgins, J P T; Frampton, G K; Greiner, M; Afonso, A; Amzal, B; Deeks, J; Dorne, J-L; Glanville, J; Lövei, G L; Nienstedt, K; O'connor, A M; Pullin, A S; Rajić, A; Verloo, D

2015-01-01

Food and feed safety risk assessment uses multi-parameter models to evaluate the likelihood of adverse events associated with exposure to hazards in human health, plant health, animal health, animal welfare, and the environment. Systematic review and meta-analysis are established methods for answering questions in health care, and can be implemented to minimize biases in food and feed safety risk assessment. However, no methodological frameworks exist for refining risk assessment multi-parameter models into questions suitable for systematic review, and use of meta-analysis to estimate all parameters required by a risk model may not be always feasible. This paper describes novel approaches for determining question suitability and for prioritizing questions for systematic review in this area. Risk assessment questions that aim to estimate a parameter are likely to be suitable for systematic review. Such questions can be structured by their "key elements" [e.g., for intervention questions, the population(s), intervention(s), comparator(s), and outcome(s)]. Prioritization of questions to be addressed by systematic review relies on the likely impact and related uncertainty of individual parameters in the risk model. This approach to planning and prioritizing systematic review seems to have useful implications for producing evidence-based food and feed safety risk assessment.

7 CFR 4280.173 - Grant funding for feasibility studies.

Code of Federal Regulations, 2013 CFR

2013-01-01

... costs will be considered eligible. Eligible project costs for renewable energy system feasibility... America Program General Renewable Energy System Feasibility Study Grants § 4280.173 Grant funding for...; and (3) Environmental study. (c) Ineligible project costs. Ineligible project costs for renewable...

7 CFR 4280.173 - Grant funding for feasibility studies.

Code of Federal Regulations, 2014 CFR

2014-01-01

... costs will be considered eligible. Eligible project costs for renewable energy system feasibility... America Program General Renewable Energy System Feasibility Study Grants § 4280.173 Grant funding for...; and (3) Environmental study. (c) Ineligible project costs. Ineligible project costs for renewable...

7 CFR 4280.173 - Grant funding for feasibility studies.

Code of Federal Regulations, 2012 CFR

2012-01-01

... costs will be considered eligible. Eligible project costs for renewable energy system feasibility... America Program General Renewable Energy System Feasibility Study Grants § 4280.173 Grant funding for...; and (3) Environmental study. (c) Ineligible project costs. Ineligible project costs for renewable...

41 CFR 101-5.104-4 - Scheduling feasibility studies.

Code of Federal Regulations, 2011 CFR

2011-07-01

... studies. 101-5.104-4 Section 101-5.104-4 Public Contracts and Property Management Federal Property... FEDERAL BUILDINGS AND COMPLEXES 5.1-General § 101-5.104-4 Scheduling feasibility studies. The schedule of feasibility studies will be coordinated by GSA with its construction, space management, and buildings...

41 CFR 101-5.104-4 - Scheduling feasibility studies.

Code of Federal Regulations, 2010 CFR

2010-07-01

... studies. 101-5.104-4 Section 101-5.104-4 Public Contracts and Property Management Federal Property... FEDERAL BUILDINGS AND COMPLEXES 5.1-General § 101-5.104-4 Scheduling feasibility studies. The schedule of feasibility studies will be coordinated by GSA with its construction, space management, and buildings...

Effects of virtual rehabilitation versus conventional physical therapy on postural control, gait, and cognition of patients with Parkinson's disease: study protocol for a randomized controlled feasibility trial.

PubMed

Silva, Keyte Guedes; De Freitas, Tatiana Beline; Doná, Flávia; Ganança, Fernando Freitas; Ferraz, Henrique Ballalai; Torriani-Pasin, Camila; Pompeu, José Eduardo

2017-01-01

There is an association among postural instability, gait dysfunction, and cognitive impairment in subjects with Parkinson's disease (PD). Difficulty in dividing attention, response inhibition, and visuospatial attention deficiencies may contribute to the impairment of motor performance during daily activities. There are strong evidences that physical therapy can prevent physical and cognitive decline in individuals with PD. Recently, the European Physiotherapy Guideline (EPG) was developed based on randomized clinical trials about the effectiveness of the physical therapy to improve the functional deficiencies of individuals with PD. The EPG did not include the use of promising new intervention as virtual reality in PD due the lack of studies about its safety, feasibility and effectiveness. Therefore, this study protocol had as objective to evaluate the feasibility, safety and effectiveness of a physical therapy program-based on the European Physiotherapy Guideline (EPG) compared to Kinect-based training on postural control, gait, cognition, and quality of life (QoL) of Individuals with PD. A single-blind, parallel, randomized, controlled feasibility trial will be conducted with a sample of 32 individuals diagnosed with idiopathic PD. Participants will be allocated into control group (CG) and experimental group (EG). The intervention of the CG will be conventional physical therapy, and the intervention of the EG will be a supervised practice of five Kinect games. Both groups will perform 14 sessions of 1 h each one, twice a week over 7 weeks. Process outcomes will be safety, feasibility, adherence, and acceptability. Safety will be assessed by the proportion of participants who experienced intervention-related adverse events or any serious adverse event during the study period. Feasibility will be assessed through the scores of the games recorded in all training sessions. Adherence will be assessed through the participant's attendance. Acceptability will be the

Percutaneous irreversible electroporation for breast tissue and breast cancer: safety, feasibility, skin effects and radiologic-pathologic correlation in an animal study.

PubMed

Li, Sheng; Chen, Fei; Shen, Lujun; Zeng, Qi; Wu, Peihong

2016-08-05

To study the safety, feasibility and skin effects of irreversible electroporation (IRE) for breast tissue and breast cancer in animal models. Eight pigs were used in this study. IRE was performed on the left breasts of the pigs with different skin-electrode distances, and the right breasts were used as controls. The electrodes were placed 1-8 mm away from the skin, with an electrode spacing of 1.5-2 cm. Imaging and pathological examinations were performed at specific time points for follow-up evaluation. Vital signs, skin damage, breast tissue changes and ablation efficacy were also closely observed. Eight rabbit models with or without VX2 breast tumor implantations were used to further assess the damage caused by and the repair of thin skin after IRE treatment for breast cancer. Contrast-enhanced ultrasound and elastosonography were used to investigate ablation efficacy and safety. During IRE, the color of the pig breast skin reversibly changed. When the skin-electrode distance was 3 mm, the breast skin clearly changed, becoming white in the center and purple in the surrounding region during IRE. One small purulent skin lesion was detected several days after IRE. When the skin-electrode distance was 5-8 mm, the breast skin became red during IRE. However, the skin architecture was normal when evaluated using gross pathology and hematoxylin-eosin staining. When the skin-electrode distance was 1 mm, skin atrophy and yellow glabrescence occurred in the rabbit breasts after IRE. When the skin-electrode distance was ≥5 mm, there was no skin damage in the rabbit model regardless of breast cancer implantation. After IRE, complete ablation of the targeted breast tissue or cancer was confirmed, and apoptosis was detected in the target tissue and outermost epidermal layer. In the ablated breasts of the surviving animals, complete mammary regeneration with normal skin and hair was observed. Furthermore, no massive fibrosis or mass formation were detected on

Feasibility, tolerability and safety of pediatric hyperpolarized 129Xe magnetic resonance imaging in healthy volunteers and children with cystic fibrosis.

PubMed

Walkup, Laura L; Thomen, Robert P; Akinyi, Teckla G; Watters, Erin; Ruppert, Kai; Clancy, John P; Woods, Jason C; Cleveland, Zackary I

2016-11-01

Hyperpolarized 129 Xe is a promising contrast agent for MRI of pediatric lung function, but its safety and tolerability in children have not been rigorously assessed. To assess the feasibility, safety and tolerability of hyperpolarized 129 Xe gas as an inhaled contrast agent for pediatric pulmonary MRI in healthy control subjects and in children with cystic fibrosis. Seventeen healthy control subjects (ages 6-15 years, 11 boys) and 11 children with cystic fibrosis (ages 8-16 years, 4 boys) underwent 129 Xe MRI, receiving up to three doses of 129 Xe gas prepared by either a commercially available or a homebuilt 129 Xe polarizer. Subject heart rate and SpO 2 were monitored for 2 min post inhalation and compared to resting baseline values. Adverse events were reported via follow-up phone call at days 1 and 30 (range ±7 days) post-MRI. All children tolerated multiple doses of 129 Xe, and no children withdrew from the study. Relative to baseline, most children who received a full dose of gas for imaging (10 of 12 controls and 8 of 11 children with cystic fibrosis) experienced a nadir in SpO 2 (mean -6.0 ± standard deviation 7.2%, P≤0.001); however within 2 min post inhalation SpO 2 values showed no significant difference from baseline (P=0.11). There was a slight elevation in heart rate (mean +6.6 ± 13.9 beats per minute [bpm], P=0.021), which returned from baseline within 2 min post inhalation (P=0.35). Brief side effects related to the anesthetic properties of xenon were mild and quickly resolved without intervention. No serious or severe adverse events were observed; in total, four minor adverse events (14.3%) were reported following 129 Xe MRI, but all were deemed unrelated to the study. The feasibility, safety and tolerability of 129 Xe MRI has been assessed in a small group of children as young as 6 years. SpO 2 changes were consistent with the expected physiological effects of a short anoxic breath-hold, and other mild side effects were

Efficacy, safety and feasibility of antifungal prophylaxis with posaconazole tablet in paediatric patients after haematopoietic stem cell transplantation.

PubMed

Döring, Michaela; Cabanillas Stanchi, Karin Melanie; Queudeville, Manon; Feucht, Judith; Blaeschke, Franziska; Schlegel, Patrick; Feuchtinger, Tobias; Lang, Peter; Müller, Ingo; Handgretinger, Rupert; Heinz, Werner J

2017-07-01

Paediatric recipients of haematopoietic stem cell transplantation (HSCT) have a high risk for invasive fungal infections. Posaconazole oral suspension has proven to be effective in antifungal prophylaxis in adult and paediatric patients. A new posaconazole tablet formulation with absorption independent of the gastric conditions was approved by the FDA in 2013. This is the first report on the use of posaconazole tablets in paediatric patients. This single-centre study included 63 paediatric patients with haemato-oncological malignancies who received posaconazole for antifungal prophylaxis after HSCT. They were analysed for efficacy, feasibility and the safety of posaconazole. Out of 63 patients, 31 received posaconazole oral suspension and 32 received posaconazole tablets up to 200 days after transplantation. Analyses of the posaconazole trough levels were determined. No possible, probable or proven invasive fungal infection was observed in either group. Posaconazole trough levels were significantly higher in the tablet group than in the suspension group at all analysed time points. Drug-related adverse events were similarly low in both groups. Posaconazole tablets are effective in preventing invasive fungal infections in paediatric patients. As early as day 3 after starting posaconazole tablets, over 50% of the posaconazole trough levels were >500 ng/mL, while this was observed on day 14 after start with posaconazole suspension. The administration of posaconazole tablets was safe, effective and feasible as antifungal prophylaxis in paediatric patients after HSCT.

Conceptual Thermal Treatment Technologies Feasibility Study

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

Suer, A.

1996-02-28

This report presents a conceptual Thermal Treatment Technologies Feasibility Study (FS) for the Savannah River Site (SRS) focusing exclusively on thermal treatment technologies for contaminated soil, sediment, or sludge remediation projects.

Feasibility Study of a Rotorcraft Health and Usage Monitoring System (HUMS): Results of Operator's Evaluation

NASA Technical Reports Server (NTRS)

Romero, Raylund; Summers, Harold; Cronkhite, James

1996-01-01

The objective was to evaluate the feasibility of a state-of-the-art health and usage monitoring system (HUMS) to provide monitoring of critical mechanical systems on the helicopter, including motors, drive train, engines, and life-limited components. The implementation of HUMS and cost integration with current maintenance procedures was assessed from the operator's viewpoint in order to achieve expected benefits from these systems, such as enhanced safety, reduced maintenance cost, and increased availability. An operational HUMS that was installed and operated under an independent flight trial program was used as a basis for this study. The HUMS equipment and software were commercially available. Based on the results of the feasibility study, the HUMS used in the flight trial program generally demonstrated a high level of reliability in monitoring the rotor system, engines, drive train, and life-limited components. The system acted as a sentinel to warn of impending failures. A worn tail rotor pitch bearing was detected by HUMS, which had the capability for self testing to diagnose system and sensor faults. Examples of potential payback to the operator with HUMS were identified, including reduced insurance cost through enhanced safety, lower operating costs derived from maintenance credits, increased aircraft availability, and improved operating efficiency. The interfacing of HUMS with current operational procedures was assessed to require only minimal revisions to the operator's maintenance manuals. Finally the success in realizing the potential benefits from HUMS technology was found to depend on the operator, helicopter manufacturer, regulator (FAA), and HUMS supplier working together.

Feasibility study report: Area of Contamination (AOC) 43J. (Fort Devens, Groups 2 and 7 sites). Final feasibility study report

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

NONE

1996-06-06

The U.S. Army Environmental Center directed ABB Environmental Services, Inc. (ABB-ES), under Contract No. DAAA15-91-D-0008, to conduct a Remedial Investigation (RI) and Feasibility Study (FS) to address the contamination of soil and groundwater at Area of Contamination (AOC) 43J at Fort Devens, Massachusetts. This FS Report is prepared as part of the FS process in accordance with the 1988 U.S. Environmental Protection Agency (USEPA) guidance document entitled Guidance for Conducting Remedial Investigations and Feasibility Studies under CERCLA. The purpose of the FS Report is to initially identify and screen potentially feasible alternatives to control human health and environmental risks atmore » AOC 43J. Following this screening, the FS Report presents a detailed analysis and comparative analysis of the retained alternatives.« less

Feasibility Study: New Knowledge Demands in Turbulent Business World

NASA Astrophysics Data System (ADS)

Sprice, Renate; Kirikova, Marite

Feasibility study is one of the early activities in information systems (IS) development when important decisions regarding choice among several possible systems development alternatives are to be made. In times of relatively stable business environment and waterfall model as a systems development approach, the role and methods of feasibility study where quite clear (Kendall and Kendall 1995). However, new software development methods and the necessity to develop more rapidly new IS or their parts may. challenge the possibility to evaluate project feasibility in the early stages of IS development.

7 CFR 4280.176 - Feasibility study grant applications-content.

Code of Federal Regulations, 2014 CFR

2014-01-01

... renewable energy system. (10) If the applicant is a rural small business, certification that the feasibility study grant will be for a renewable energy system project that is located in a rural area. (11) The... Energy for America Program General Renewable Energy System Feasibility Study Grants § 4280.176...

7 CFR 4280.176 - Feasibility study grant applications-content.

Code of Federal Regulations, 2013 CFR

2013-01-01

... renewable energy system. (10) If the applicant is a rural small business, certification that the feasibility study grant will be for a renewable energy system project that is located in a rural area. (11) The... Energy for America Program General Renewable Energy System Feasibility Study Grants § 4280.176...

7 CFR 4280.176 - Feasibility study grant applications-content.

Code of Federal Regulations, 2012 CFR

2012-01-01

... renewable energy system. (10) If the applicant is a rural small business, certification that the feasibility study grant will be for a renewable energy system project that is located in a rural area. (11) The... Energy for America Program General Renewable Energy System Feasibility Study Grants § 4280.176...

Precipitation measurement using SIR-C: A feasibility study

NASA Technical Reports Server (NTRS)

Ahamad, Atiq; Moore, Richard K.

1993-01-01

A precipitation detection and measurement experiment is planned for the SIR-C/X-SAR mission. This study was conducted to determine under what conditions an off-nadir experiment is feasible. The signal-to-clutter ratio, the signal-to-noise ratio, and the minimum detectable rain rate were investigated. Available models, used in previous studies, were used for the surface clutter and the rain echo. The study also considers the attenuation of the returns at X band. It was concluded that an off-nadir rain-measurement experiment is feasible only for rain rates greater than 10 mm/hr for look angles greater than 60 deg. For the range of look angles 5 less than theta(sub 1) less than 50, the rain rate required is very high for adequate signal-to-clutter ratio, and hence the feasibility of the experiment.

Feasibility Study of a Novel Thoraco-abdominal Aortic Hybrid Device (SPIDER-graft) in a Translational Pig Model.

PubMed

Debus, Eike S; Kölbel, Tilo; Duprée, Anna; Daum, Günter; Sandhu, Harleen K; Manzoni, Daniel; Wipper, Sabine H

2018-02-01

The hybrid SPIDER-graft consists of a proximal descending aortic stent graft and a conventional six branched Dacron graft for open abdominal aortic repair. Technical feasibility with regard to avoiding thoracotomy and extracorporeal circulation (ECC) during thoraco-abdominal aortic hybrid repair and peri-procedural safety of this novel device are unknown. This was a feasibility and safety study in domestic pigs (75-85 kg). The abdominal aorta including iliac bifurcation, left renal artery, and visceral arteries were exposed via retroperitoneal access. The right iliac branch was first temporarily anastomosed end to side to the distal aorta via partial clamping. During inflow reduction and infra-coeliac cross-clamping, the coeliac trunk (CT) was divided and the proximal stent graft portion of the SPIDER-graft was deployed into the descending aorta via the CT ostium. Retrograde visceral and antegrade aorto-iliac blood flow was maintained via the iliac side branch. The visceral, renal, and iliac arteries were sequentially anastomosed, finally replacing the first iliac end to side anastomosis. Technical success, blood flow, periods of ischaemia, and peri-procedural complications were evaluated after intra-operative completion angiography and post-operative computed tomography angiography. Six animals underwent successful thoracic stent graft deployment and distal open reconstruction without peri-operative death. The median thoracic graft implantation time was 4.5 min, and the median ischaemia times before reperfusion were 10 min for the CT, 8 min for the superior mesenteric artery, 13 min for the right renal artery, and 22 min for the left renal artery. Angiography demonstrated appropriate graft implantation and blood flow measurements confirmed sufficient blood flow through all side branches. In this translational pig model, thoraco-abdominal hybrid repair using the novel SPIDER-graft was successful in avoiding thoracotomy and ECC. Technical feasibility and

Numerical aerodynamic simulation facility feasibility study

NASA Technical Reports Server (NTRS)

1979-01-01

There were three major issues examined in the feasibility study. First, the ability of the proposed system architecture to support the anticipated workload was evaluated. Second, the throughput of the computational engine (the flow model processor) was studied using real application programs. Third, the availability reliability, and maintainability of the system were modeled. The evaluations were based on the baseline systems. The results show that the implementation of the Numerical Aerodynamic Simulation Facility, in the form considered, would indeed be a feasible project with an acceptable level of risk. The technology required (both hardware and software) either already exists or, in the case of a few parts, is expected to be announced this year. Facets of the work described include the hardware configuration, software, user language, and fault tolerance.

Feasibility study for a transportation operations system cask maintenance facility

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

Rennich, M.J.; Medley, L.G.; Attaway, C.R.

The US Department of Energy (DOE), Office of Civilian Radioactive Waste Management (OCRWM) is responsible for the development of a waste management program for the disposition of spent nuclear fuel (SNF) and high-level waste (HLW). The program will include a transportation system for moving the nuclear waste from the sources to a geologic repository for permanent disposal. Specially designed casks will be used to safely transport the waste. The cask systems must be operated within limits imposed by DOE, the Nuclear Regulatory Commission (NRC), and the Department of Transportation (DOT). A dedicated facility for inspecting, testing, and maintaining the caskmore » systems was recommended by the General Accounting Office (in 1979) as the best means of assuring their operational effectiveness and safety, as well as regulatory compliance. In November of 1987, OCRWM requested a feasibility study be made of a Cask Maintenance Facility (CMF) that would perform the required functions. 46 refs., 16 figs., 13 tabs.« less

Feasibility and safety of a novel in vivo model to assess playground falls in children.

PubMed

Ehrlich, Peter F; Young, Justin G; Ulin, Sheryl; Wooley, Charles; Armstrong, Thomas J; Buschmann, Bethany; Galecki, Andrzej; Ashton-Miller, James A

2013-07-01

Falls are the leading cause of nonfatal unintentional injuries among hospitalized children with playground equipment accounting for more than 50%. National standards for playground rung and rail design exist, but there a lack of in vivo models available to test these standards. We developed a novel in vivo model to test rung and rail design. We report the feasibility and safety of the model. A device was built to simulate children hanging onto a playground bar until their hand slips off. This was defined as breakaway strength. The handle unit was mounted on a vertical cable that was mechanically raised and lowered using a linear actuator controlled by the experimenter. The unit was padded and contained a video camera that recorded the posture of the hand during each trial. Breakaway force and torque were recorded as they held onto the handle by LabView software. In addition, standard anthropometrics and grip strength were recorded. Biomedical engineering approved the device. There were 425 eligible students aged 5 years to 11 years. Of these, 93% (397) participated (212 males and 185 females). Ninety-nine percent (396 of 397) completed all three experimental stations, one declined because of fear. There were no injuries and no falls. Average time to complete the study was 22 ± 0.5 minutes. Ninety-one percent of participants were right handed; the ethnicity was representative of the local area with 79% being white. Mean ± SD height, weight, and body mass index for the 397 participants were 1.28 ± 0.11 m, 28.0 ± 8.12 kg, and 16.31 ± 2.59 kg/m², respectively. Hand size, grip strength, and maximum breakaway force increased with age. This model is safe and feasible and maybe a viable method to assess rung and rail design for playgrounds.

Cardiopulmonary Exercise Testing in Patients with Asymptomatic or Equivocal Symptomatic Aortic Stenosis: Feasibility, Reproducibility, Safety and Information Obtained on Exercise Physiology.

PubMed

van Le, Douet; Jensen, Gunnar Vagn Hagemann; Carstensen, Steen; Kjøller-Hansen, Lars

2016-01-01

The aim of this study was to determine the feasibility, reproducibility, safety and information obtained on exercise physiology from cardiopulmonary exercise testing (CPX) in patients with aortic stenosis. Patients with an aortic valve area (AVA) <1.3 cm2 who were judged asymptomatic or equivocal symptomatic underwent CPX and an inert gas rebreathing test. Only those where comprehensive evaluation of CPX results indicated haemodynamic compromise from aortic stenosis were referred for valve replacement. The mean patient age was 72 (±9) years; an AVA index <0.6 cm2/m2 and equivocal symptomatic status were found in 90 and 70%, respectively. CPX was feasible in 130 of the 131 patients. The coefficients of repeatability by test-retest were 5.4% (pVO2) and 4.6% (peak O2 pulse). A pVO2 <83% of the expected was predicted by a lower stroke volume at exercise, lower peak heart rate and FEV1, and higher VE/VCO2, but not by AVA index. Equivocal symptomatic status and a low gradient but high valvulo-arterial impedance were associated with a lower pVO2, but not with an inability to increase stroke volume. In total, 18 patients were referred for valve replacement. At 1 year, no cardiovascular deaths had occurred. CPX was feasible and reproducible and provided comprehensive data on exercise physiology. A CPX-guided treatment strategy was safe up to 1 year. © 2015 S. Karger AG, Basel.

41 CFR 101-5.104-3 - Data requirements for feasibility studies.

Code of Federal Regulations, 2010 CFR

2010-07-01

... feasibility studies. 101-5.104-3 Section 101-5.104-3 Public Contracts and Property Management Federal Property... FEDERAL BUILDINGS AND COMPLEXES 5.1-General § 101-5.104-3 Data requirements for feasibility studies. (a) The data requirements for feasibility studies may vary from program to program, but shall be standard...

41 CFR 101-5.104-3 - Data requirements for feasibility studies.

Code of Federal Regulations, 2013 CFR

2013-07-01

... feasibility studies. 101-5.104-3 Section 101-5.104-3 Public Contracts and Property Management Federal Property... FEDERAL BUILDINGS AND COMPLEXES 5.1-General § 101-5.104-3 Data requirements for feasibility studies. (a) The data requirements for feasibility studies may vary from program to program, but shall be standard...

41 CFR 101-5.104-3 - Data requirements for feasibility studies.

Code of Federal Regulations, 2012 CFR

2012-07-01

... feasibility studies. 101-5.104-3 Section 101-5.104-3 Public Contracts and Property Management Federal Property... FEDERAL BUILDINGS AND COMPLEXES 5.1-General § 101-5.104-3 Data requirements for feasibility studies. (a) The data requirements for feasibility studies may vary from program to program, but shall be standard...

41 CFR 101-5.104-3 - Data requirements for feasibility studies.

Code of Federal Regulations, 2014 CFR

2014-07-01

... feasibility studies. 101-5.104-3 Section 101-5.104-3 Public Contracts and Property Management Federal Property... FEDERAL BUILDINGS AND COMPLEXES 5.1-General § 101-5.104-3 Data requirements for feasibility studies. (a) The data requirements for feasibility studies may vary from program to program, but shall be standard...

41 CFR 101-5.104-3 - Data requirements for feasibility studies.

Code of Federal Regulations, 2011 CFR

2011-07-01

... feasibility studies. 101-5.104-3 Section 101-5.104-3 Public Contracts and Property Management Federal Property... FEDERAL BUILDINGS AND COMPLEXES 5.1-General § 101-5.104-3 Data requirements for feasibility studies. (a) The data requirements for feasibility studies may vary from program to program, but shall be standard...

Para-aortic lymphadenectomy in advanced stage cervical cancer, a protocol for comparing safety, feasibility and diagnostic accuracy of surgical staging versus PET-CT; PALDISC trial.

PubMed

Tax, Casper; Abbink, Karin; Rovers, Maroeska M; Bekkers, Ruud L M; Zusterzeel, Petra L M

2018-01-01

Currently, a PET-CT is used to assess the need for extended field radiotherapy of para-aortic lymph nodes (PALN) in International Federation of Gynaecology and Obstetrics (FIGO) stage IB2, IIA2-IVA (locally advanced stage) cervical cancer. A small study established a sensitivity and specificity estimate for PALN metastases of 50% (95% CI; 7-93%) and 83% (95% CI; 52-98%), respectively. Surgical staging of PALN may lead to a higher diagnostic accuracy. However, surgical staging of para-aortic lymph nodes in locally advanced stage cervical cancer is not common practice. Therefore, a phase 2 randomised controlled trial is needed to assess its safety and feasibility. In addition to standard imaging (MRI or CT scan) with PET-CT, 30 adult women with FIGO stage IB2, IIA2-IVA cervical cancer will be randomised to receive either surgical staging or usual PET-CT staging. Administering extended field radiotherapy will be based on lymphadenectomy results for the intervention group and on the PET-CT results for the control group. Follow-up visits at 0, 3, 6, 9 and 12 months will assess health-related quality of life and progression-free survival.Primary safety and feasibility outcomes of surgical staging will be assessed by calculating means with 95% confidence intervals for duration of surgery, number of complications, blood loss, nodal yield after para-aortic lymphadenectomy and treatment delay due to surgical staging. Secondary patient-centred outcomes on quality of life and first year survival will be documented and compared between the two groups. Estimates of sensitivity, specificity and negative and positive predictive values of MRI, PET-CT and surgical staging will be presented with 95% CI.. All analysis will be performed according to the intention to treat principle. This study will assess safety and feasibility, expressed as the number and severity of complications, effect on quality of life and the treatment delay due to surgically staging para-aortic lymph nodes in

Early Mobilization in Ischemic Stroke: A Pilot Randomized Trial of Safety and Feasibility in a Public Hospital in Brazil

PubMed Central

Poletto, Simone Rosa; Rebello, Letícia Costa; Valença, Maria Júlia Monteiro; Rossato, Daniele; Almeida, Andrea Garcia; Brondani, Rosane; Chaves, Márcia Lorena Fagundes; Nasi, Luiz Antônio; Martins, Sheila Cristina Ouriques

2015-01-01

Background The effect of early mobilization after acute stroke is still unclear, although some studies have suggested improvement in outcomes. We conducted a randomized, single-blind, controlled trial seeking to evaluate the feasibility, safety, and benefit of early mobilization for patients with acute ischemic stroke treated in a public teaching hospital in Southern Brazil. This report presents the feasibility and safety findings for the pilot phase of this trial. Methods The primary outcomes were time to first mobilization, total duration of mobilization, complications during early mobilization, falls within 3 months, mortality within 3 months, and medical complications of immobility. We included adult patients with CT- or MRI-confirmed ischemic stroke within 48 h of symptom onset who were admitted from March to November 2012 to the acute vascular unit or general emergency unit of a large urban emergency department (ED) at the Hospital de Clínicas de Porto Alegre. The severity of the neurological deficit on admission was assessed by the National Institutes of Health Stroke Scale (NIHSS). The NIHSS and modified Rankin Scale (mRS, functional outcome) scores were assessed on day 14 or at discharge as well as at 3 months. Activities of daily living (ADL) were measured with the modified Barthel Index (mBI) at 3 months. Results Thirty-seven patients (mean age 65 years, mean NIHSS score 11) were randomly allocated to an intervention group (IG) or a control group (CG). The IG received earlier (p = 0.001) and more frequent (p < 0.0001) mobilization than the CG. Of the 19 patients in the CG, only 5 (26%) underwent a physical therapy program during hospitalization. No complications (symptomatic hypotension or worsening of neurological symptoms) were observed in association with early mobilization. The rates of complications of immobility (pneumonia, pulmonary embolism, and deep vein thrombosis) and mortality were similar in the two groups. No statistically significant

Feasibility of Genome-Wide Screening for Biosafety Assessment of Probiotics: A Case Study of Lactobacillus helveticus MTCC 5463.

PubMed

Senan, S; Prajapati, J B; Joshi, C G

2015-12-01

Recent years have witnessed an explosion in genome sequencing of probiotic strains for accurate identification and characterization. Regulatory bodies are emphasizing on the need for performing phase I safety studies for probiotics. The main hypothesis of this study was to explore the feasibility of using genome databases for safety screening of strains. In this study, we attempted to develop a framework for the safety assessment of a potential probiotic strain, Lactobacillus helveticus MTCC 5463 based on genome mining for genes associated with antibiotic resistance, production of harmful metabolites, and virulence. The sequencing of MTCC 5463 was performed using GS-FLX Titanium reagents. Genes coding for antibiotic resistance and virulence were identified using Antibiotic Resistance Genes Database and Virulence Factors Database. Results indicated that MTCC 5463 carried antibiotic resistance genes associated with beta-lactam and fluoroquinolone. There is no threat of transfer of these genes to host gut commensals because the genes are not plasmid encoded. The presence of genes for adhesion, biofilm, surface proteins, and stress-related proteins provides robustness to the strain. The presence of hemolysin gene in the genome revealed a theoretical risk of virulence. The results of in silico analysis complemented the in vitro studies and human clinical trials, confirming the safety of the probiotic strain. We propose that the safety assessment of probiotic strains administered live at high doses using a genome-wide screening could be an effective and time-saving tool for identifying prognostic biomarkers of biosafety.

Safety and feasibility of chronic transvenous phrenic nerve stimulation for treatment of central sleep apnea in heart failure patients.

PubMed

Zhang, Xilong; Ding, Ning; Ni, Buqing; Yang, Bing; Wang, Hong; Zhang, Shi-Jiang

2017-03-01

Central sleep apnea (CSA) is common in patients with heart failure (HF) and is associated with poor quality of life and prognosis. Early acute studies using transvenous phrenic nerve stimulation (PNS) to treat CSA in HF have shown a significantly reduction of CSA and improvement of key polysomnographic parameters. In this study, we evaluated the safety of and efficiency chronic transvenous PNS with an implanted neurostimulator in HF patients with CSA. This study was a prospective, nonrandomized evaluation of unilateral transvenous PNS in eight HF patients with CSA. The stimulation lead, which connected to a proprietary neurostimulator, was positioned in either the left pericardiophrenic or right brachiocephalic vein. Monitoring during implantation and 6-monthly follow-ups were performed. Six of the implanted eight patients completed the study (one was lost to follow-up; one died from pneumonia). Neither side effects nor adverse events related to stimulation occurred. During the 6-monthly follow-ups, one patient had a lead dislodgement in the first month and the lead was subsequently repositioned. No additional lead dislodgements occurred. There were no significant changes in sleep habits, appetite, bleeding or infections. Compared with the parameters before stimulator implantation, there were significant improvement in apnea-hypopnea index, central apnea index, left ventricular ejection fraction and 6-min walk distance (all P < 0.01). Use of chronic transvenous PNS appears to be safe and feasible in HF patients with CSA. Large multicenter studies are needed to confirm safety and efficacy in this population. © 2015 John Wiley & Sons Ltd.

Virtual Reality Exposure Therapy for the Treatment of Dental Phobia: A Controlled Feasibility Study.

PubMed

Gujjar, Kumar Raghav; van Wijk, Arjen; Sharma, Ratika; de Jongh, Ad

2018-05-01

Virtual reality exposure therapy (VRET) has been used to treat a variety of fears and phobias. To determine the feasibility (i.e. safety and efficacy) of using VRET to treat dental phobia. Safety was evaluated by determining any adverse events or symptom exacerbation. Efficacy of VRET was evaluated by comparing the reduction in dental anxiety scores (measured 16 times within a 14-week study period, and at 6-month follow-up), and its behavioural effects with that of an informational pamphlet (IP) on ten randomized patients with dental phobia using a controlled multiple baseline design. Participants' heart rate response during VRET, and their experience post-VRET, were indexed. No personal adverse events or symptom exacerbation occurred. Visual analysis and post-hoc intention-to-treat analysis showed a significantly greater decrease in dental anxiety scores [higher PND (percentage of non-overlap data) scores of 100% and lower POD (percentage of overlap data) of 0%, Modified Dental Anxiety Scale, F (1,8) = 8.61, p = 0.019, and Dental Fear Scale, F (1,8) = 10.53, p = 0.012], and behavioural avoidance in the VRET compared with the IP group [d = 4.2 and -1.4, respectively). There was no increase in average heart rate during VRET. Of the nine treatment completers, six (four from the VRET group and two from the IP group) no longer had dental phobia at 6-month follow-up. Four of the five VRET participants, but none of the IP participants, scheduled a dental treatment appointment following the intervention. VRET is a feasible alternative for patients with dental phobia.

Application of visualization and simulation program to improve work zone safety and mobility.

DOT National Transportation Integrated Search

2010-01-01

A previous study sponsored by the Smart Work Zone Deployment Initiative, Feasibility of Visualization and Simulation Applications to Improve Work Zone Safety and Mobility, demonstrated the feasibility of combining readily available, inexpensive...

Application of visualization and simulation program to improve work zone safety and mobility.

DOT National Transportation Integrated Search

2010-01-01

"A previous study sponsored by the Smart Work Zone Deployment Initiative, Feasibility of Visualization and Simulation Applications to Improve Work Zone Safety and Mobility, demonstrated the feasibility of combining readily available, inexpensiv...

Improving Patient Safety in Public Hospitals: Developing Standard Measures to Track Medical Errors and Process Breakdowns.

PubMed

Ackerman, Sara L; Gourley, Gato; Le, Gem; Williams, Pamela; Yazdany, Jinoos; Sarkar, Urmimala

2018-03-14

The aim of the study was to develop standards for tracking patient safety gaps in ambulatory care in safety net health systems. Leaders from five California safety net health systems were invited to participate in a modified Delphi process sponsored by the Safety Promotion Action Research and Knowledge Network (SPARKNet) and the California Safety Net Institute in 2016. During each of the three Delphi rounds, the feasibility and validity of 13 proposed patient safety measures were discussed and prioritized. Surveys and transcripts from the meetings were analyzed to understand the decision-making process. The Delphi process included eight panelists. Consensus was reached to adopt 9 of 13 proposed measures. All 9 measures were unanimously considered valid, but concern was expressed about the feasibility of implementing several of the measures. Although safety net health systems face high barriers to standardized measurement, our study demonstrates that consensus can be reached on acceptable and feasible methods for tracking patient safety gaps in safety net health systems. If accompanied by the active participation key stakeholder groups, including patients, clinicians, staff, data system professionals, and health system leaders, the consensus measures reported here represent one step toward improving ambulatory patient safety in safety net health systems.

Missouri toll feasibility study : phase I

DOT National Transportation Integrated Search

2002-05-01

The purpose of this toll feasibility study is to estimate the potential revenue that could be generated from several candidate toll projects within the state. Potential toll revenue may then be considered in combination with other possible funding me...

Early Feasibility Study of a Transcatheter Tricuspid Valve Annuloplasty: SCOUT Trial 30-Day Results.

PubMed

Hahn, Rebecca T; Meduri, Christopher U; Davidson, Charles J; Lim, Scott; Nazif, Tamim M; Ricciardi, Mark J; Rajagopal, Vivek; Ailawadi, Gorav; Vannan, Mani A; Thomas, James D; Fowler, Dale; Rich, Stuart; Martin, Randy; Ong, Geraldine; Groothuis, Adam; Kodali, Susheel

2017-04-11

The SCOUT (Percutaneous Tricuspid Valve Annuloplasty System for Symptomatic Chronic Functional Tricuspid Regurgitation) trial is a prospective, single-arm, multicenter, early feasibility study of a novel transcatheter device to plicate the tricuspid annulus (TA) and reduce tricuspid regurgitation (TR). This study tested the feasibility and safety of a novel transcatheter device and assessed its early performance and functional outcomes. Between November 2015 and June 2016, 15 patients with New York Heart Association (NYHA) functional class ≥II and moderate or greater functional TR were enrolled. Primary performance and safety endpoint outcomes were technically successful at 30 days with no reintervention. Echocardiographic measurements (TA diameter, effective regurgitant orifice area [EROA], left ventricular stroke volume [LVSV]) and quality-of-life (QoL) measurements (NYHA functional class, Minnesota Living with Heart Failure Questionnaire [MLHFQ], and 6-min walk test [6MWT]) were performed at baseline and 30 days. All patients (mean 73.2 ± 6.9 years of age, 87% female) underwent successful device implantation with no deaths, strokes, bleeding, tamponade, or valve reintervention. Technical success rate at 30 days was 80%, with 3 single-pledget annular detachments without reintervention. In the remaining 12 patients, there were significant reductions in TA (12.3 ± 3.1 cm 2 to 11.3 ± 2.7 cm 2 , respectively; p = 0.019) and EROA (0.51 ± 0.18 cm 2 vs. 0.32 ± 0.18 cm 2 , respectively; p = 0.020), with significant increase in LVSV (63.6 ± 17.9 ml vs. 71.5 ± 25.7 ml, respectively; p = 0.021). In the intention-to-treat cohort, there were significant improvements in NYHA functional class (≥1 class, p = 0.001), MLHFQ (47.4 ± 17.6 to 20.9 ± 14.8; p < 0.001), and 6MWT (245.2 ± 110.1 to 298.0 m ± 107.6 m; p = 0.008). The 30-day results of the SCOUT trial confirmed the safety of the novel transcatheter device, which reduced TA and EROA, increased LVSV

Safety and feasibility of nasopharyngeal evaporative cooling in the emergency department setting in survivors of cardiac arrest.

PubMed

Busch, H-J; Eichwede, F; Födisch, M; Taccone, F S; Wöbker, G; Schwab, T; Hopf, H-B; Tonner, P; Hachimi-Idrissi, S; Martens, P; Fritz, H; Bode, Ch; Vincent, J-L; Inderbitzen, B; Barbut, D; Sterz, F; Janata, A

2010-08-01

Mild therapeutic hypothermia improves survival and neurologic recovery in primary comatose survivors of cardiac arrest. Cooling effectivity, safety and feasibility of nasopharyngeal cooling with the RhinoChill device (BeneChill Inc., San Diego, USA) were determined for induction of therapeutic hypothermia. Eleven emergency departments and intensive care units participated in this multi-centre, single-arm descriptive study. Eighty-four patients after successful resuscitation from cardiac arrest were cooled with nasopharyngeal delivery of an evaporative coolant for 1h. Subsequently, temperature was controlled with systemic cooling at 33 degrees C. Cooling rates, adverse events and neurologic outcome at hospital discharge using cerebral performance categories (CPC; CPC 1=normal to CPC 5=dead) were documented. Temperatures are presented as median and the range from the first to the third quartile. Nasopharyngeal cooling for 1h reduced tympanic temperature by median 2.3 (1.6; 3.0) degrees C, core temperature by 1.1 (0.7; 1.5) degrees C. Nasal discoloration occurred during the procedure in 10 (12%) patients, resolved in 9, and was persistent in 1 (1%). Epistaxis was observed in 2 (2%) patients. Periorbital gas emphysema occurred in 1 (1%) patient and resolved spontaneously. Thirty-four of 84 patients (40%) patients survived, 26/34 with favorable neurological outcome (CPC of 1-2) at discharge. Nasopharyngeal evaporative cooling used for 1h in primary cardiac arrest survivors is feasible and safe at flow rates of 40-50L/min in a hospital setting. Copyright 2010 Elsevier Ireland Ltd. All rights reserved.

Peer Coaching Through mHealth Targeting Physical Activity in People With Parkinson Disease: Feasibility Study

PubMed Central

Latham, Nancy K; Quintiliani, Lisa M

2018-01-01

Background Long-term engagement in exercise and physical activity mitigates the progression of disability and increases quality of life in people with Parkinson disease (PD). Despite this, the vast majority of individuals with PD are sedentary. There is a critical need for a feasible, safe, acceptable, and effective method to assist those with PD to engage in active lifestyles. Peer coaching through mobile health (mHealth) may be a viable approach. Objective The purpose of this study was to develop a PD-specific peer coach training program and a remote peer-mentored walking program using mHealth technology with the goal of increasing physical activity in persons with PD. We set out to examine the feasibility, safety, and acceptability of the programs along with preliminary evidence of individual-level changes in walking activity, self-efficacy, and disability in the peer mentees. Methods A peer coach training program and a remote peer-mentored walking program using mHealth was developed and tested in 10 individuals with PD. We matched physically active persons with PD (peer coaches) with sedentary persons with PD (peer mentees), resulting in 5 dyads. Using both Web-based and in-person delivery methods, we trained the peer coaches in basic knowledge of PD, exercise, active listening, and motivational interviewing. Peer coaches and mentees wore FitBit Zip activity trackers and participated in daily walking over 8 weeks. Peer dyads interacted daily via the FitBit friends mobile app and weekly via telephone calls. Feasibility was determined by examining recruitment, participation, and retention rates. Safety was assessed by monitoring adverse events during the study period. Acceptability was assessed via satisfaction surveys. Individual-level changes in physical activity were examined relative to clinically important differences. Results Four out of the 5 peer pairs used the FitBit activity tracker and friends function without difficulty. A total of 4 of the 5 pairs

Static Magnetic Field Therapy for Carpal Tunnel Syndrome: A Feasibility Study

PubMed Central

Colbert, Agatha P.; Markov, Marko S.; Carlson, Nels; Gregory, William L.; Carlson, Hans; Elmer, Patricia J.

2010-01-01

Objectives To assess the feasibility of conducting trials of static magnetic field (SMF) therapy for carpal tunnel syndrome (CTS), to collect preliminary data on the effectiveness of two SMF dosages and to explore the influence of a SMF on median nerve conduction. Design Randomized, double blind, sham controlled trial with 6-week intervention and 12-week follow-up. Setting University hospital outpatient clinics Participants Women and men (N=60), ages 21–65, with electrophysiologically-confirmed CTS diagnosis, recruited from the general population. Interventions Participants wore nightly either neodymium magnets that delivered either 15 or 45mTesla (mT) to the contents of the carpal canal, or a non-magnetic disk. Main Outcome Measures Symptom Severity Scale (SSS) and Function Severity Scale (FSS) of the Boston Carpal Tunnel Questionnaire (BCTQ) and 4 median nerve parameters: sensory distal latency, sensory nerve action potential amplitude, motor distal latency and compound motor action potential amplitude). Results 58 of 60 randomized participants completed the study. There were no significant between-group differences for change in the primary endpoint SSS or for FSS or median nerve conduction parameters. For the SSS and the FSS each group showed a reduction at 6-weeks indicating improvement in symptoms. Conclusions This study demonstrated the feasibility and safety of testing SMF therapy for CTS. There were no between-group differences observed for the BCTQ or median nerve parameters following 6 weeks of SMF therapy. Significant within-group, symptomatic improvements of the same magnitude were experienced by participants in both active and sham magnet groups. Future studies are needed to optimize SMF dosimetry and resolve issues related to the use of sham controls in SMF trials. PMID:20599049

Feasibility and safety of catheter ablation of electrical storm in ischemic dilated cardiomyopathy.

PubMed

Dello Russo, Antonio; Casella, Michela; Pelargonio, Gemma; Santangeli, Pasquale; Bartoletti, Stefano; Bencardino, Gianluigi; Al-Mohani, Ghaliah; Innocenti, Ester; Di Biase, Luigi; Avella, Andrea; Pappalardo, Augusto; Carbucicchio, Corrado; Bellocci, Fulvio; Fiorentini, Cesare; Natale, Andrea; Tondo, Claudio

2016-06-01

Electrical storm is an emergency in 'implantation of a cardioverter defibrillator' carriers with ischemic dilated cardiomyopathy (DCM) and negatively impacts long-term prognosis. We evaluated the feasibility, safety, and effectiveness of radiofrequency catheter ablation (RFCA) in controlling electrical storm and its impact on survival and ventricular tachycardia/fibrillation recurrence. We enrolled 27 consecutive patients (25 men, age 73.1 ± 6.5 years) with ischemic DCM and an indication to RFCA for drug-refractory electrical storm. The immediate outcome was defined as failure or success, depending on whether the patient's clinical ventricular tachycardia could still be induced after RFCA; electrical storm resolution was defined as no sustained ventricular tachycardia/ventricular fibrillation in the next 7 days. Of the 27 patients, 1 died before RFCA; in the remaining 26 patients, a total of 33 RFCAs were performed. In all 26 patients, RFCA was successful, although in 6/26 patients (23.1%), repeated procedures were needed, including epicardial ablation in 3/26 (11.5%). In 23/26 patients (88.5%), electrical storm resolution was achieved. At a follow-up of 16.7 ± 8.1 months, 5/26 patients (19.2%) had died (3 nonsudden cardiac deaths, 2 noncardiac deaths) and 10/26 patients (38.5%) had ventricular tachycardia recurrence; none had electrical storm recurrence. A worse long-term outcome was associated with lower glomerular filtration rate, wider baseline QRS, and presence of atrial fibrillation before electrical storm onset. In patients with ischemic DCM, RFCA is well tolerated, feasible and effective in the acute management of drug-refractory electrical storm. It is associated with a high rate of absence of sustained ventricular tachycardia episodes over the subsequent 7 days. After successful ablation, long-term outcome was mainly predicted by baseline clinical variables.

41 CFR 101-5.104-6 - Conduct of feasibility studies.

Code of Federal Regulations, 2011 CFR

2011-07-01

... studies. 101-5.104-6 Section 101-5.104-6 Public Contracts and Property Management Federal Property... FEDERAL BUILDINGS AND COMPLEXES 5.1-General § 101-5.104-6 Conduct of feasibility studies. An initial... and detailed procedures to be followed in the conduct of each feasibility study. Arrangements will be...

41 CFR 101-5.104-6 - Conduct of feasibility studies.

Code of Federal Regulations, 2010 CFR

2010-07-01

... studies. 101-5.104-6 Section 101-5.104-6 Public Contracts and Property Management Federal Property... FEDERAL BUILDINGS AND COMPLEXES 5.1-General § 101-5.104-6 Conduct of feasibility studies. An initial... and detailed procedures to be followed in the conduct of each feasibility study. Arrangements will be...

Feasibility of Forecasting Highway Safety in Support of Safety Incentive and Safety Target Programs.

DOT National Transportation Integrated Search

2007-11-01

Using the frequency of fatal crashes from the current observation period (e.g. month, year, etc.) as the : prediction of expected future performance does not account for changes in safety that result from : increases in exposure (population, addition...

Electromechanical Actuation Feasibility Study

DTIC Science & Technology

1976-05-01

FORMA11ON SLRVicE U. S. DPMfmft1 OF COMMOM AmR 703CR IIGRT DYNAM1U8 LABORATOY AMR 706C YST TM- COMMAND\\ ~WRIGUT-PATTEAWNk AIR POW= RASL OHIO 45M8...AMIE AND0 ACGRIESS 52 RIEPOR01T DATE Air Force Flight Dy-namics Labcratory May 1976 AFSC/AFWAL, United States Air Force 11 sNjsBsIm OF PAGIES Wright... Air Force under Contract Fý3615-75-C-305, Electronechanical Actuation Feasibility Study. The contract was aaministereu by the Air Force Flioht Dynamics

Polarized-interferometer feasibility study

NASA Technical Reports Server (NTRS)

Raab, F. H.

1983-01-01

The feasibility of using a polarized-interferometer system as a rendezvous and docking sensor for two cooperating spacecraft was studied. The polarized interferometer is a radio frequency system for long range, real time determination of relative position and attitude. Range is determined by round trip signal timing. Direction is determined by radio interferometry. Relative roll is determined from signal polarization. Each spacecraft is equipped with a transponder and an antenna array. The antenna arrays consist of four crossed dipoles that can transmit or receive either circularly or linearly polarized signals. The active spacecraft is equipped with a sophisticated transponder and makes all measurements. The transponder on the passive spacecraft is a relatively simple repeater. An initialization algorithm is developed to estimate position and attitude without any a priori information. A tracking algorithm based upon minimum variance linear estimators is also developed. Techniques to simplify the transponder on the passive spacecraft are investigated and a suitable configuration is determined. A multiple carrier CW signal format is selected. The dependence of range accuracy and ambiguity resolution error probability are derived and used to design a candidate system. The validity of the design and the feasibility of the polarized interferometer concept are verified by simulation.

A pilot feasibility study of neurofeedback for children with autism.

PubMed

Steiner, Naomi J; Frenette, Elizabeth; Hynes, Caitlin; Pisarik, Elizabeth; Tomasetti, Kathryn; Perrin, Ellen C; Rene, Kirsten

2014-06-01

Neurofeedback (NFB) is an emerging treatment for children with autism spectrum disorder (ASD). This pilot study examined the feasibility of NFB for children with ASD. Ten children ages 7-12 with high functioning ASD and attention difficulties received a NFB attention training intervention. A standardized checklist captured feasibility, including focus during exercises and academic tasks, as well as off-task behaviors. Active behaviors and vocalizations were the most frequent off-task behaviors. Positive reinforcement and breaks including calm breathing exercises were the most common supports. Low motivation was associated with higher feasibility challenges, yet parental involvement and accommodations were helpful. This pilot study shows that it is feasible to conduct NFB sessions with children with high functioning autism and attention difficulties.

Demonstration of the Safety and Feasibility of Robotically Assisted Percutaneous Coronary Intervention in Complex Coronary Lesions: Results of the CORA-PCI Study (Complex Robotically Assisted Percutaneous Coronary Intervention).

PubMed

Mahmud, Ehtisham; Naghi, Jesse; Ang, Lawrence; Harrison, Jonathan; Behnamfar, Omid; Pourdjabbar, Ali; Reeves, Ryan; Patel, Mitul

2017-07-10

The aims of this study were to evaluate the feasibility and technical success of robotically assisted percutaneous coronary intervention (R-PCI) for the treatment of coronary artery disease (CAD) in clinical practice, especially in complex lesions, and to determine the safety and clinical success of R-PCI compared with manual percutaneous coronary intervention (M-PCI). R-PCI is safe and feasible for simple coronary lesions. The utility of R-PCI for complex coronary lesions is unknown. All consecutive PCI procedures performed robotically (study group) or manually (control group) over 18 months were included. R-PCI technical success, defined as the completion of the procedure robotically or with partial manual assistance and without a major adverse cardiovascular event, was determined. Procedures ineligible for R-PCI (i.e., atherectomy, planned 2-stent strategy for bifurcation lesion, chronic total occlusion requiring hybrid approach) were excluded for analysis from the M-PCI group. Clinical success, defined as completion of the PCI procedure without a major adverse cardiovascular event, procedure time, stent use, and fluoroscopy time were compared between groups. A total of 315 patients (mean age 67.7 ± 11.8 years; 78% men) underwent 334 PCI procedures (108 R-PCIs, 157 lesions, 78.3% type B2/C; 226 M-PCIs, 336 lesions, 68.8% type B2/C). Technical success with R-PCI was 91.7% (rate of manual assistance 11.1%, rate of manual conversion 7.4%, rate of major adverse cardiovascular events 0.93%). Clinical success (99.1% with R-PCI vs. 99.1% with M-PCI; p = 1.00), stent use (stents per procedure 1.59 ± 0.79 with R-PCI vs. 1.54 ± 0.75 with M-PCI; p = 0.73), and fluoroscopy time (18.2 ± 10.4 min with R-PCI vs. 19.2 ± 11.4 min with M-PCI; p = 0.39) were similar between the groups, although procedure time was longer in the R-PCI group (44:30 ± 26:04 min:s vs. 36:34 ± 23:03 min:s; p = 0.002). Propensity-matched analysis confirmed that procedure time was longer

Nintendo Wii Fit as an adjunct to physiotherapy following lower limb fractures: preliminary feasibility, safety and sample size considerations.

PubMed

McPhail, S M; O'Hara, M; Gane, E; Tonks, P; Bullock-Saxton, J; Kuys, S S

2016-06-01

The Nintendo Wii Fit integrates virtual gaming with body movement, and may be suitable as an adjunct to conventional physiotherapy following lower limb fractures. This study examined the feasibility and safety of using the Wii Fit as an adjunct to outpatient physiotherapy following lower limb fractures, and reports sample size considerations for an appropriately powered randomised trial. Ambulatory patients receiving physiotherapy following a lower limb fracture participated in this study (n=18). All participants received usual care (individual physiotherapy). The first nine participants also used the Wii Fit under the supervision of their treating clinician as an adjunct to usual care. Adverse events, fracture malunion or exacerbation of symptoms were recorded. Pain, balance and patient-reported function were assessed at baseline and discharge from physiotherapy. No adverse events were attributed to either the usual care physiotherapy or Wii Fit intervention for any patient. Overall, 15 (83%) participants completed both assessments and interventions as scheduled. For 80% power in a clinical trial, the number of complete datasets required in each group to detect a small, medium or large effect of the Wii Fit at a post-intervention assessment was calculated at 175, 63 and 25, respectively. The Nintendo Wii Fit was safe and feasible as an adjunct to ambulatory physiotherapy in this sample. When considering a likely small effect size and the 17% dropout rate observed in this study, 211 participants would be required in each clinical trial group. A larger effect size or multiple repeated measures design would require fewer participants. Copyright © 2015 Chartered Society of Physiotherapy. Published by Elsevier Ltd. All rights reserved.

The effect of safety initiatives on safety performance: a longitudinal study.

PubMed

Hoonakker, Peter; Loushine, Todd; Carayon, Pascale; Kallman, James; Kapp, Andrew; Smith, Michael J

2005-07-01

Construction industry is one of the most dangerous industries, not only in the USA, but worldwide. In this longitudinal study we examined the effects of safety initiatives on the safety performance of construction companies. One of the measures commonly used in the USA to track a company's safety performance is the experience modification rate (EMR). The EMR is based on the company's safety records (injury claims) from the past three full years and is used to calculate the workers' compensation insurance premiums. In a longitudinal study, we studied the effects of safety efforts and initiatives on the EMR. The results show that safety initiatives and money spent on safety do improve safety performance, but only over time.

Feasibility of community-based careHPV for cervical cancer prevention in rural Thailand.

PubMed

Trope, Lee A; Chumworathayi, Bandit; Blumenthal, Paul D

2013-07-01

This study aimed to assess the safety, acceptability and feasibility of primary human papillomavirus (HPV) testing for cervical cancer prevention at the community level in a low-resource setting. After training a technician to run specimens on the careHPV unit, the study team traveled to a different village each day in rural Roi-et Province, Thailand. Women were tested for HPV using self-swab, followed by careHPV testing. Those with positive result were assessed immediately by visual inspection with acetic acid. Women positive for HPV and visual inspection with acetic acid were offered cryotherapy. Safety was determined by monitoring adverse events. Exit surveys assessed acceptability and feasibility. Feasibility was also assessed by measuring testing and triage throughputs. Technician training required 2.5 days to achieve competency. A total of 431 women were screened in 14 days, with an average of 31 women screened daily. No adverse events were reported. Women deemed the program overwhelmingly acceptable: 90.5% reported that they would take the self-swab again, 71.3% preferred the self-swab to a clinician swab. The program was also feasible: 99.8% of eligible women agreed to testing, 94.8% returned for same-day follow-up, and women only spent 30 to 50 minutes of their total time with the program from screening to results. Cervical cancer prevention programs based on self-swab HPV testing could be safe, acceptable, feasible, and effective at the community level in low-resource settings.

North Carolina Library Networking Feasibility Study.

ERIC Educational Resources Information Center

Griffiths, Jose-Marie; King, Donald W.

This report presents the results of a feasibility study of statewide multitype library networking in North Carolina. Potential network functions, products, services, sources, and costs are covered, but questions of network governance, management, and funding are not directly addressed. The report begins with background information and a…

Trauma-sensitive yoga as an adjunct mental health treatment in group therapy for survivors of domestic violence: A feasibility study

PubMed Central

Clark, Cari Jo; Lewis-Dmello, Angela; Anders, Deena; Parsons, Amy; Nguyen-Feng, Viann; Henn, Lisa; Emerson, David

2014-01-01

This study is a feasibility test of whether incorporating trauma-sensitive yoga into group therapy for female victims of partner violence improves symptoms of anxiety, depression, and posttraumatic stress disorder (PTSD) beyond that achieved with group therapy alone. Seventeen (9 control, 8 intervention) adult female clients seeking group psychotherapy were enrolled. A 12-week trauma-sensitive yoga protocol was administered once weekly for 30–40 min at the end of each group therapy session. The control group received typical group psychotherapy. Feasibility was assessed through recruitment and retention rates as well as participants’ self-reported perceptions of the safety and utility of the study. The study enrolled 85% (17/20) of those screened eligible. Loss to follow-up was 30% (5/17). No one reported emotional or physical harm. All of the respondents reported that the study was personally meaningful and that the results would be useful to others. PMID:25129883

Martin Van Buren National Historic Site alternative transportation feasibility study.

DOT National Transportation Integrated Search

2012-05-31

The Martin Van Buren National Historic Site (MVBNHS) Alternative Transportation Feasibility Study examines the feasibility of : alternative transportation system (ATS) service to MVBNHS. The report investigates opportunities for a shuttle carrying vi...

Tubeless simultaneous bilateral percutaneous nephrolithotomy: safety, feasibility and efficacy in an Indian setting.

PubMed

Pillai, Sunil; Mishra, Dilip; Sharma, Pritam; Venkatesh, Giridhar; Chawla, Arun; Hegde, Padmaraj; Thomas, Joseph

2014-05-01

To study the safety, feasibility and efficacy of tubeless simultaneous bilateral percutaneous nephrolithotomy. We retrospectively studied 85 patients who underwent tubeless simultaneous bilateral percutaneous nephrolithotomy in the Department of Urology, Kasturba Medical College, Manipal, Karnataka, India, from July 2006 to June 2013. The demographic profile and outcomes were compared with the other existing series reported in the literature. A total of 65 male and 20 female patients with a mean age of 45.7 ± 11.6 years underwent tubeless simultaneous bilateral percutaneous nephrolithotomy. The mean stone burden was 299 mm(2), with 12 staghorn calculi. Mean operative time was 87.6 ± 35.5 min. A total of 95% of stones were cleared with single access tracts. The success rate of tubeless simultaneous bilateral percutaneous nephrolithotomy (stone clearance) was 95.2%. Mean hemoglobin drop was 1.1 ± 0.9 gm% per patient, with 10.5% of patients requiring blood transfusion. Mean hospital stay was 69.6 ± 28.4 h. Complications included urosepsis (Clavien grade 4), acute kidney injury requiring hemodialysis (grade 3), pneumonia (grade = 2) and hydrothorax requiring intercostal drainage tube insertion (grade 3). On follow up, 4.7% of the renal units required ancillary procedures. Our findings confirm that tubeless simultaneous bilateral percutaneous nephrolithotomy is a safe and effective modality of treatment. It allows obviating a second anesthetic exposure, thus reducing analgesic requirement, hospitalization time and costs. This translates into a significant socioeconomic impact on the outlook of Indian patients presenting with bilateral renal stone disease. © 2013 The Japanese Urological Association.

Petersburg National Battlefield : alternative transportation feasibility study

DOT National Transportation Integrated Search

2012-11-13

This report studies the feasibility of alternative solutions to several transportation problems affecting Petersburg National Battlefield in Petersburg, Virginia. Current transportation problems include site-specific access issues, wayfinding and nav...

Ute Mountain Ute Tribe Community-Scale Solar Feasibility Study

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

Rapp, Jim; Knight, Tawnie

2014-01-30

Parametrix Inc. conducted a feasibility study for the Ute Mountain Ute Tribe to determine whether or not a community-scale solar farm would be feasible for the community. The important part of the study was to find where the best fit for the solar farm could be. In the end, a 3MW community-scale solar farm was found best fit with the location of two hayfield sites.

Safety, feasibility, and acceptability of visual inspection with acetic acid and immediate treatment with cryotherapy in rural Laos.

PubMed

Phongsavan, Keokedthong; Phengsavanh, Alongkone; Wahlström, Rolf; Marions, Lena

2011-09-01

To assess the safety, acceptability, and feasibility of visual inspection with acetic acid (VIA) followed by immediate treatment with cryotherapy as a single-visit approach for the prevention of cervical cancer among women in rural Laos. In 2009, women from 2 provinces in Laos were recruited for cervical cancer screening using VIA. If the inspection of the cervix showed a well-defined acetowhite lesion close to the os, immediate cryotherapy was offered. Of the 1926 women who were included, 134 (7.0%) tested positive on VIA. Of these, 113 (84.3%) underwent immediate cryotherapy and none declined treatment. One year after immediate cryotherapy, 77 (68.1%) women returned for a follow-up assessment and 68 (88.3%) were now VIA-negative. There was no report of a major complication during or after treatment. The acceptance of both VIA and cryotherapy was high. Visual inspection with acetic acid is a simple test that requires minimal infrastructure and expenditure. Integration of VIA with cryotherapy at the primary care level may constitute a feasible program for the prevention of cervical cancer in Laos. Copyright © 2011 International Federation of Gynecology and Obstetrics. Published by Elsevier Ireland Ltd. All rights reserved.

Safety and feasibility of intra-operative device closure of atrial septal defect with transthoracic minimal invasion.

PubMed

Chen, Qiang; Cao, Hua; Zhang, Gui-Can; Chen, Liang-Wan; Chen, Dao-Zhong

2012-01-01

The study aims to evaluate the safety and feasibility of intra-operative device closure of atrial septal defect with transthoracic minimal invasion. From May 2006 to June 2009, 252 patients with secundum-type atrial septal defect closure were enrolled in our institution. The patients were divided into two groups, with 182 patients in group I with intra-operative device closure and 72 in group II with surgical closure. In group I, the patients' age ranged from 3 months to 62 years (mean±standard deviation, 19.0±16.7 years). This approach involved a transthoracic minimal invasion that was performed after full evaluation of the atrial septal defect by transthoracic echocardiography, deploying the device through the delivery sheath to occlude the atrial septal defect. In group I, 180 patients were occluded successfully under this approach. The size of the occluder device implanted ranged from 6 to 48 mm. Minor complications occurred, which included transient arrhythmias (n=23) and pleural effusion (n=15). Two patients with postoperative cardiac arrest were successfully cardiopulmonary resuscitated. Another two patients with occluder dislodged back into the right atrium were turned to surgical repair with cardiopulmonary bypass on the postoperative day. In group II, all patients were occluded successfully, and almost all patients needed blood transfusion and suffered from various minor complications. All discharged patients were followed up for 1-5 years. During this period, we found no recurrence, no thrombosis, even no device failure. In our comparative studies, group II had significantly longer intensive care unit (ICU) stay and hospital stay than group I (p<0.05). The cost for group I was less than group II (p<0.05). Intra-operative device closure of atrial septal defect with transthoracic minimal invasion is a safe and feasible technique. It had the advantages of cost savings, yielding better cosmetic results, and leaving less trauma than surgical closure.

Feasibility and Safety of a Virtual Reality Dodgeball Intervention for Chronic Low Back Pain: A Randomized Clinical Trial.

PubMed

Thomas, James S; France, Christopher R; Applegate, Megan E; Leitkam, Samuel T; Walkowski, Stevan

2016-12-01

Whereas the fear-avoidance model of chronic low back pain (CLBP) posits a generic avoidance of movement that is perceived as threatening, we have repeatedly shown that individuals with high fear and CLBP specifically avoid flexion of the lumbar spine. Accordingly, we developed a virtual dodgeball intervention designed to elicit graded increases in lumbar spine flexion while reducing expectations of fear and harm by engaging participants in a competitive game that is entertaining and distracting. We recruited 52 participants (48% female) with CLBP and high fear of movement and randomized them to either a game group (n = 26) or a control group (n = 26). All participants completed a pregame baseline and a follow-up assessment (4-6 days later) of lumbar spine motion and expectations of pain and harm during standardized reaches to high (easier), middle, and low (hardest to reach) targets. For 3 consecutive days, participants in the game group completed 15 minutes of virtual dodgeball between baseline and follow-up. For the standardized reaching tests, there were no significant effects of group on changes in lumbar spine flexion, expected pain, or expected harm. However, virtual dodgeball was effective at increasing lumbar flexion within and across gameplay sessions. Participants reported strong positive endorsement of the game, no increases in medication use, pain, or disability, and no adverse events. Although these findings indicate that very brief exposure to this game did not translate to significant changes outside the game environment, this was not surprising because graded exposure therapy for fear of movement among individuals with low back pain typically last 8 to 12 sessions. Because of the demonstration of safety, feasibility, and ability to encourage lumbar flexion within gameplay, these findings provide support for a clinical trial wherein the treatment dose is more consistent with traditional graded exposure approaches to CLBP. This study of a

The use of in-situ simulation to improve safety in the plastic surgery office: a feasibility study.

PubMed

Shapiro, Fred E; Pawlowski, John B; Rosenberg, Noah M; Liu, Xiaoxia; Feinstein, David M; Urman, Richard D

2014-01-01

Simulation-based interventions and education can potentially contribute to safer and more effective systems of care. We utilized in-situ simulation to highlight safety issues, regulatory requirements, and assess perceptions of safety processes by the plastic surgery office staff. A high-fidelity human patient simulator was brought to an office-based plastic surgery setting to enact a half-day full-scale, multidisciplinary medical emergency. Facilitated group debriefings were conducted after each scenario with special consideration of the principles of team training, communication, crisis management, and adherence to evidence-based protocols and regulatory standards. Abbreviated AHRQ Medical Office Safety Culture Survey was completed by the participants before and after the session. The in-situ simulations had a high degree of acceptance and face validity according to the participants. Areas highlighted by the simulation sessions included rapid communication, delegation of tasks, location of emergency materials, scope of practice, and logistics of transport. The participant survey indicated greater awareness of patient safety issues following participation in simulation and debriefing exercises in 3 areas (P < 0.05): the need to change processes if there is a recognized patient safety issue (100% vs 75%), openness to ideas about improving office processes (100% vs 88%), and the need to discuss ways to prevent errors from recurring (88% vs 62%). Issues of safety and regulatory compliance can be assessed in an office-based setting through the short-term (half-day) use of in-situ simulation with facilitated debriefing and the review of audiovisual recordings by trained facilities inspectors.

The Use of In-Situ Simulation to Improve Safety in the Plastic Surgery Office: A Feasibility Study

PubMed Central

Shapiro, Fred E.; Pawlowski, John B.; Rosenberg, Noah M.; Liu, Xiaoxia; Feinstein, David M.; Urman, Richard D.

2014-01-01

Objective: Simulation-based interventions and education can potentially contribute to safer and more effective systems of care. We utilized in-situ simulation to highlight safety issues, regulatory requirements, and assess perceptions of safety processes by the plastic surgery office staff. Methods: A high-fidelity human patient simulator was brought to an office-based plastic surgery setting to enact a half-day full-scale, multidisciplinary medical emergency. Facilitated group debriefings were conducted after each scenario with special consideration of the principles of team training, communication, crisis management, and adherence to evidence-based protocols and regulatory standards. Abbreviated AHRQ Medical Office Safety Culture Survey was completed by the participants before and after the session. Results: The in-situ simulations had a high degree of acceptance and face validity according to the participants. Areas highlighted by the simulation sessions included rapid communication, delegation of tasks, location of emergency materials, scope of practice, and logistics of transport. The participant survey indicated greater awareness of patient safety issues following participation in simulation and debriefing exercises in 3 areas (P < 0.05): the need to change processes if there is a recognized patient safety issue (100% vs 75%), openness to ideas about improving office processes (100% vs 88%), and the need to discuss ways to prevent errors from recurring (88% vs 62%). Conclusions: Issues of safety and regulatory compliance can be assessed in an office-based setting through the short-term (half-day) use of in-situ simulation with facilitated debriefing and the review of audiovisual recordings by trained facilities inspectors. PMID:24501616

Harm Reduction Text Messages Delivered During Alcohol Drinking: Feasibility Study Protocol

PubMed Central

2012-01-01

Background: Recent research using mobile phone interventions to address public health issues such as smoking, obesity, depression, and diabetes provides a basis for trialing a similar approach toward reducing the negative consequences of risky drinking. Objective: This feasibility study aims to recruit drinkers between 18–34 years to a website where they will design and enter their own personal messages (repeating or one-off) to be sent to their mobile phones when they are drinking to remind them of their pre-drinking safety intentions. Methods/Design: Participants in the treatment group will have access to the messaging function for 3 months and will be compared to a control group who will have 3 months access to a web chat site only. Data collection will occur at baseline, 3 months, and 6 months. The primary outcome is a change in unintended negative consequences from drinking at 3 months. Secondary outcomes include the acceptability of the intervention to this population, recruitment rate, participant retention, reduction in alcohol consumption, and the self-motivation discourse in participant messages. Discussion: Existing alcohol interventions in New Zealand attempt to reduce alcohol consumption in the population, but with little effect. This study aims to target unintended negative consequences resulting from drinking by empowering the drinkers themselves to deliver safety messages during the drinking session. If proven effective, this strategy could provide a cost-effective means of reducing the public health burden associated with risky drinking. Trial Registration: Australia and New Zealand Clinical Trials Register (ANZCTR): ACTRN12611000242921 PMID:23611773

Feasibility and safety of a novel magnetic-assisted capsule endoscope system in a preliminary examination for upper gastrointestinal tract.

PubMed

Lien, Gi-Shih; Wu, Ming-Shun; Chen, Chun-Nan; Liu, Chih-Wen; Suk, Fat-Moon

2018-04-01

Current capsule endoscopy procedures are ineffective for upper gastrointestinal (GI) tract examination because they do not allow for operator-controlled navigation of the capsule. External controllability of a capsule endoscope with an applied magnetic field is a possible solution to this problem. We developed a novel magnetic-assisted capsule endoscope (MACE) system to visualize the entire upper GI tract. The present study evaluated the safety and feasibility of the MACE system for the examination of the upper GI tract, including the esophagus, stomach, and duodenum. The present open clinical study enrolled ten healthy volunteers. All participants swallowed a MACE, and an external magnetic field navigator was used for magnetic capsule manipulation in the upper GI tract. We assessed the maneuverability of the magnetic capsule and completeness of the MACE examination as well as the safety and tolerability of the procedure. The present study enrolled ten healthy volunteers with a mean age and body mass index of 47.7 years and 25.6 kg/m 2 , respectively. One volunteer withdrew because of difficulty in swallowing the capsule. In total, nine volunteers underwent the MACE examination. The average examination time was 27.1 min. The maneuverability of the capsule was assessed as good and fair in 55.6 and 44.4% of the participants, respectively. The overall completeness of the examination in the esophagus, stomach, and duodenum was 100, 85.2, and 86.1%, respectively. No severe adverse events occurred during this study. All participants exhibited satisfactory tolerance of the MACE examination. The MACE system has satisfactory maneuverability and visualization completeness with excellent acceptance and tolerance.

76 FR 70152 - Pilot Program for Early Feasibility Study Investigational Device Exemption Applications

Federal Register 2010, 2011, 2012, 2013, 2014

2011-11-10

...] Pilot Program for Early Feasibility Study Investigational Device Exemption Applications AGENCY: Food and... feasibility study investigational device exemption (IDE) applications. The pilot program will conform to the... Feasibility Medical Device Clinical Studies, Including Certain First in Human (FIH) Studies.'' Under the pilot...

Feasibility Study for a Combined Radiation Environment in the ACRR-FRECII Cavity.

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

Parma, Edward J.

The objective of this report is to determine the feasibility of a combined pulsed - power accelerator machine, similar to HERMES - III, with the Annular Core Research Reactor (ACRR) Fueled - Ring External Cavity (FREC - II) in a new facility. The document is conceptual in nature, and includes some neutronic analysis that i llustrates that that the physics of such a concept would be feasible. There would still be many engineering design considerations and issues that would need to be investigated in order to determine the true viability of such a concept. This report does n ot addressmore » engineering design details, the cost of such a facility, or what would be required to develop the safety authorization of the concept. The radiation requirements for the "on - target" gamma - ray dose and dose rate are not addressed in this report . It is assumed that if the same general on - target specifications for a HERMES - III type machine could be met with the proposed concept, that the machine would b e considered highly useful as a radiation effects sciences platform. In general, the combined accelerator/ACRR reactor concept can be shown to be feasible with no major issues that would preclude the usefulness of such a facility. The new facility would provide a capability that currently does not exist in the radiation testing complex.« less

Feasibility study of the welding of SiC

NASA Technical Reports Server (NTRS)

Moore, T. J.

1985-01-01

In a brief study of the feasibility of welding sintered alpha-SiC, solid-state welding and brazing were investigated. Joint quality was determined solely by microstructural examination. Hot-pressure welding was shown to be feasible at 1950 C. Diffusion welding and brazing were also successful under hot isostatic pressure at 1950 C when boride, carbide, and silicide interlayers were used. Furnace brazing was accomplished at 1750 C when a TiSi2 interlayer was introduced.

Lunar Analog Feasibility Study Results

NASA Technical Reports Server (NTRS)

Cromwell, Ronita L.; Neigut, Joe

2009-01-01

This slide presentation reviews a study designed to determine the feasibility of using a 9.5 deg head-up tilt bed rest model to simulate the effects of the 1/6 g load to the human body that exists on the lunar surface. The effect of different types of compression stockings, the pre-bed rest diet, and the use of a specific exercise program were reviewed for comfort, force verification and plasma volume shift

43 CFR 404.47 - How will a feasibility study be conducted under this program?

Code of Federal Regulations, 2011 CFR

2011-10-01

... 43 Public Lands: Interior 1 2011-10-01 2011-10-01 false How will a feasibility study be conducted... Studies § 404.47 How will a feasibility study be conducted under this program? Feasibility studies will be... feasibility study, including the Principles and Guidelines (incorporated by reference at § 404.4). You can...

77 FR 13343 - Pilot Program for Early Feasibility Study Investigational Device Exemption Applications...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-03-06

...] Pilot Program for Early Feasibility Study Investigational Device Exemption Applications; Termination of... acceptance of nominations for the Early Feasibility Study Investigational Device Exemption (IDE) Applications... technologies to participate in a pilot program for early feasibility study IDE applications. FDA is also...

Educating preschoolers about sun safety.

PubMed Central

Loescher, L J; Emerson, J; Taylor, A; Christensen, D H; McKinney, M

1995-01-01

OBJECTIVES. This feasibility study examined whether a sun safety curriculum designed for and administered to preschoolers affects their cognition (knowledge, comprehension, application) regarding sun safety. METHODS. Twelve classes of 4- to 5-year-olds were recruited from local preschools and randomly assigned to an intervention group or a control group. The intervention group received an investigator-developed sun safety curriculum; the control group did not. Children in both groups were tested at the beginning of the study about their cognition related to sun safety. They then received posttests 2 and 7 weeks following the pretest. RESULTS. The curriculum had a significant effect on the knowledge (P = .01) and comprehension (P = .006) components of cognition. The application component of cognition was not significantly changed by the curriculum. CONCLUSIONS. A structured curriculum was found to be an efficacious means of enhancing knowledge and comprehension of sun safety in preschool children. At the preoperational developmental stage, however, children may not be able to apply such knowledge and comprehension. PMID:7604917

Peer Coaching Through mHealth Targeting Physical Activity in People With Parkinson Disease: Feasibility Study.

PubMed

Colón-Semenza, Cristina; Latham, Nancy K; Quintiliani, Lisa M; Ellis, Terry D

2018-02-15

Long-term engagement in exercise and physical activity mitigates the progression of disability and increases quality of life in people with Parkinson disease (PD). Despite this, the vast majority of individuals with PD are sedentary. There is a critical need for a feasible, safe, acceptable, and effective method to assist those with PD to engage in active lifestyles. Peer coaching through mobile health (mHealth) may be a viable approach. The purpose of this study was to develop a PD-specific peer coach training program and a remote peer-mentored walking program using mHealth technology with the goal of increasing physical activity in persons with PD. We set out to examine the feasibility, safety, and acceptability of the programs along with preliminary evidence of individual-level changes in walking activity, self-efficacy, and disability in the peer mentees. A peer coach training program and a remote peer-mentored walking program using mHealth was developed and tested in 10 individuals with PD. We matched physically active persons with PD (peer coaches) with sedentary persons with PD (peer mentees), resulting in 5 dyads. Using both Web-based and in-person delivery methods, we trained the peer coaches in basic knowledge of PD, exercise, active listening, and motivational interviewing. Peer coaches and mentees wore FitBit Zip activity trackers and participated in daily walking over 8 weeks. Peer dyads interacted daily via the FitBit friends mobile app and weekly via telephone calls. Feasibility was determined by examining recruitment, participation, and retention rates. Safety was assessed by monitoring adverse events during the study period. Acceptability was assessed via satisfaction surveys. Individual-level changes in physical activity were examined relative to clinically important differences. Four out of the 5 peer pairs used the FitBit activity tracker and friends function without difficulty. A total of 4 of the 5 pairs completed the 8 weekly phone

UMCS feasibility study for Fort George G. Meade. Volume 1

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

NONE

1996-12-01

Fort George G. Meade selected eighty-three (83) buildings, from the approximately 1,500 buildings on the base to be included in the UMCS Feasibility Study. The purpose of the study is to evaluate the feasibility of replacing the existing analog based Energy Monitoring and Control System (EMCS) with a new distributed process Monitoring and Control System (UMCS).

Psilocybin with psychological support for treatment-resistant depression: an open-label feasibility study.

PubMed

Carhart-Harris, Robin L; Bolstridge, Mark; Rucker, James; Day, Camilla M J; Erritzoe, David; Kaelen, Mendel; Bloomfield, Michael; Rickard, James A; Forbes, Ben; Feilding, Amanda; Taylor, David; Pilling, Steve; Curran, Valerie H; Nutt, David J

2016-07-01

Psilocybin is a serotonin receptor agonist that occurs naturally in some mushroom species. Recent studies have assessed the therapeutic potential of psilocybin for various conditions, including end-of-life anxiety, obsessive-compulsive disorder, and smoking and alcohol dependence, with promising preliminary results. Here, we aimed to investigate the feasibility, safety, and efficacy of psilocybin in patients with unipolar treatment-resistant depression. In this open-label feasibility trial, 12 patients (six men, six women) with moderate-to-severe, unipolar, treatment-resistant major depression received two oral doses of psilocybin (10 mg and 25 mg, 7 days apart) in a supportive setting. There was no control group. Psychological support was provided before, during, and after each session. The primary outcome measure for feasibility was patient-reported intensity of psilocybin's effects. Patients were monitored for adverse reactions during the dosing sessions and subsequent clinic and remote follow-up. Depressive symptoms were assessed with standard assessments from 1 week to 3 months after treatment, with the 16-item Quick Inventory of Depressive Symptoms (QIDS) serving as the primary efficacy outcome. This trial is registered with ISRCTN, number ISRCTN14426797. Psilocybin's acute psychedelic effects typically became detectable 30-60 min after dosing, peaked 2-3 h after dosing, and subsided to negligible levels at least 6 h after dosing. Mean self-rated intensity (on a 0-1 scale) was 0·51 (SD 0·36) for the low-dose session and 0·75 (SD 0·27) for the high-dose session. Psilocybin was well tolerated by all of the patients, and no serious or unexpected adverse events occurred. The adverse reactions we noted were transient anxiety during drug onset (all patients), transient confusion or thought disorder (nine patients), mild and transient nausea (four patients), and transient headache (four patients). Relative to baseline, depressive symptoms were markedly reduced 1

Feasibility of ballistic strength training in sub-acute stroke: A randomized, controlled, assessor-blinded pilot study.

PubMed

Hendrey, Genevieve; Clark, Ross A; Holland, Anne E; Mentiplay, Benjamin F; Davis, Carly; Windfeld-Lund, Cristie; Raymond, Melissa J; Williams, Gavin

2018-05-30

To establish the feasibility and effectiveness of a six week ballistic strength training protocol in people with stroke. Randomized, controlled, assessor-blinded study. Sub-acute inpatient rehabilitation. Consecutively admitted inpatients with a primary diagnosis of first ever stroke with lower limb weakness, functional ambulation category score of ≥3, and ability to walk ≥14m were screened for eligibility to recruit 30 participants for randomization. Participants were randomized to standard therapy or ballistic strength training three times per week for six weeks. The primary aim was to evaluate feasibility and outcomes included recruitment rate, participant retention and attrition, feasibility of the exercise protocol, therapist burden and participant safety. Secondary outcomes included measures of mobility, lower limb muscle strength, muscle power and quality of life. Thirty participants (11% of those screened) with mean age of 50 (SD 18) years were randomized. The median number of sessions attended was 15/18 and 17/18 for the ballistic and control groups respectively. Earlier than expected discharge home (n=4) and illness (n=7) were the most common reasons for non-attendance. Participants performed the exercises safely, with no study-related adverse events. There were significant (p<0.05) between-group changes favoring the ballistic group for comfortable gait velocity (mean difference (MD) 0.31m/s, 95% confidence interval CI: 0.08 to 0.52), muscle power, as measured by peak jump height (MD 8cm, 95% CI: 3 to 13) and peak propulsive velocity (MD 64cm/s, 95% CI: 17 to 112). Ballistic training was safe and feasible in select ambulant people with stroke. Similar rates of retention and attrition suggest that ballistic training was acceptable to patients. Secondary outcomes provide promising results that warrant further investigation in a larger trial. Copyright © 2018. Published by Elsevier Inc.

A task-oriented circuit training in multiple sclerosis: a feasibility study

PubMed Central

2014-01-01

Background The aim of this study was to evaluate the safety, feasibility and preliminary effects of a high-intensity rehabilitative task-oriented circuit training (TOCT) in a sample of multiple sclerosis (MS) subjects on walking competency, mobility, fatigue and health-related quality of life (HRQoL). Methods 24 MS subjects (EDSS 4.89 ± 0.54, 17 female and 7 male, 52.58 ± 11.21 years, MS duration 15.21 ± 8.68 years) have been enrolled and randomly assigned to 2 treatment groups: (i) experimental group received 10 TOCT sessions over 2 weeks (2 hours/each session) followed by a 3 months home exercise program, whereas control group did not receive any specific rehabilitation intervention. A feasibility patient-reported questionnaire was administered after TOCT. Functional outcome measures were: walking endurance (Six Minute Walk Test), gait speed (10 Meter Walk Test), mobility (Timed Up and Go test) and balance (Dynamic Gait Index). Furthermore, self-reported questionnaire of motor fatigue (Fatigue Severity Scale), walking ability (Multiple Sclerosis Walking Scale – 12) and health-related quality of life (Multiple Sclerosis Impact Scale – 29) were included. Subjects’ assessments were delivered at baseline (T0), after TOCT (T1) and 3 months of home-based exercise program (T2). Results After TOCT subjects reported a positive global rating on the received treatment. At 3 months, we found a 58.33% of adherence to the home-exercise program. After TOCT, walking ability and health-related quality of life were improved (p < 0.05) with minor retention after 3 months. The control group showed no significant changes in any variables. Conclusions This two weeks high-intensity task-oriented circuit class training followed by a three months home-based exercise program seems feasible and safe in MS people with moderate mobility impairments; moreover it might improve walking abilities. Trial registration NCT01464749 PMID:24906545

Advanced Space Suit Insulation Feasibility Study

NASA Technical Reports Server (NTRS)

Trevino, Luis A.; Orndoff, Evelyne S.

2000-01-01

For planetary applications, the space suit insulation has unique requirements because it must perform in a dynamic mode to protect humans in the harsh dust, pressure and temperature environments. Since the presence of a gaseous planetary atmosphere adds significant thermal conductance to the suit insulation, the current multi-layer flexible insulation designed for vacuum applications is not suitable in reduced pressure planetary environments such as that of Mars. Therefore a feasibility study has been conducted at NASA to identify the most promising insulation concepts that can be developed to provide an acceptable suit insulation. Insulation concepts surveyed include foams, microspheres, microfibers, and vacuum jackets. The feasibility study includes a literature survey of potential concepts, an evaluation of test results for initial insulation concepts, and a development philosophy to be pursued as a result of the initial testing and conceptual surveys. The recommended focus is on microfibers due to the versatility of fiber structure configurations, the wide choice of fiber materials available, the maturity of the fiber processing industry, and past experience with fibers in insulation applications

Study of extraterrestrial disposal of radioactive wastes. Part 3: Preliminary feasibility screening study of space disposal of the actinide radioactive wastes with 1 percent and 0.1 percent fission product contamination

NASA Technical Reports Server (NTRS)

Hyland, R. E.; Wohl, M. L.; Finnegan, P. M.

1973-01-01

A preliminary study was conducted of the feasibility of space disposal of the actinide class of radioactive waste material. This waste was assumed to contain 1 and 0.1 percent residual fission products, since it may not be feasible to completely separate the actinides. The actinides are a small fraction of the total waste but they remain radioactive much longer than the other wastes and must be isolated from human encounter for tens of thousands of years. Results indicate that space disposal is promising but more study is required, particularly in the area of safety. The minimum cost of space transportation would increase the consumer electric utility bill by the order of 1 percent for earth escape and 3 percent for solar escape. The waste package in this phase of the study was designed for normal operating conditions only; the design of next phase of the study will include provisions for accident safety. The number of shuttle launches per year required to dispose of all U.S. generated actinide waste with 0.1 percent residual fission products varies between 3 and 15 in 1985 and between 25 and 110 by 2000. The lower values assume earth escape (solar orbit) and the higher values are for escape from the solar system.

A distributed research network model for post-marketing safety studies: the Meningococcal Vaccine Study.

PubMed

Velentgas, Priscilla; Bohn, Rhonda L; Brown, Jeffrey S; Chan, K Arnold; Gladowski, Patricia; Holick, Crystal N; Kramer, Judith M; Nakasato, Cynthia; Spettell, Claire M; Walker, Alexander M; Zhang, Fang; Platt, Richard

2008-12-01

We describe a multi-center post-marketing safety study that uses distributed data methods to minimize the need for covered entities to share protected health information (PHI). Implementation has addressed several issues relevant to creation of a large scale post-marketing drug safety surveillance system envisioned by the FDA's Sentinel Initiative. This retrospective cohort study of Guillain-Barré syndrome (GBS) following meningococcal conjugate vaccination incorporates the data and analytic expertise of five research organizations closely affiliated with US health insurers. The study uses administrative claims data, plus review of full text medical records to adjudicate the status of individuals with a diagnosis code for GBS (ICD9 357.0). A distributed network approach is used to create the analysis files and to perform most aspects of the analysis, allowing nearly all of the data to remain behind institutional firewalls. Pooled analysis files transferred to a central site will contain one record per person for approximately 0.2% of the study population, and contain PHI limited to the month and year of GBS onset for cases or the index date for matched controls. The first planned data extraction identified over 9 million eligible adolescents in the target age range of 11-21 years. They contributed an average of 14 months of eligible time on study over 27 months of calendar time. MCV4 vaccination coverage levels exceeded 20% among 17-18-year olds and 16% among 11-13 and 14-16-year-old age groups by the second quarter of 2007. This study demonstrates the feasibility of using a distributed data network approach to perform large scale post-marketing safety analyses and is scalable to include additional organizations and data sources. We believe these results can inform the development of a large national surveillance system. Copyright (c) 2008 John Wiley & Sons, Ltd.

MacMillan Pier Transportation Center Feasibility Study.

DOT National Transportation Integrated Search

2006-06-01

The MacMillan Pier Transportation Center Feasibility Study examines two potential sites (landside and waterside) for a transportation center that provides a range of tourist and traveler information. It would serve as a gateway for Provincetown and t...

Systematic review and meta-analysis of feasibility, safety, and efficacy of a novel procedure: associating liver partition and portal vein ligation for staged hepatectomy.

PubMed

Schadde, Erik; Schnitzbauer, Andreas A; Tschuor, Christoph; Raptis, Dimitri A; Bechstein, Wolf O; Clavien, Pierre-Alain

2015-09-01

Associating liver partition and portal vein ligation for staged hepatectomy (ALPPS) is a novel strategy to resect liver tumors despite the small size of the liver remnant. It is an hepatectomy in two stages, with PVL and parenchymal transection during the first stage, which induces rapid growth of the remnant liver exceeding any other technique. Despite high postoperative morbidity and mortality in most reports, the technique was adopted by a number of surgeons. This systematic review explores current data regarding the feasibility, safety, and oncologic efficacy of ALPPS; the search strategy has been published online. A meta-analysis of hypertrophy, feasibility (ALPPS stage 2 performed), mortality, complications, and R0 (complete) resection was performed. A literature search revealed a total of 13 publications that met the search criteria, reporting data from 295 patients. Evidence levels were low, with the highest Oxford evidence level being 2c. The most common indication was colorectal liver metastasis in 203 patients. Hypertrophy in the meta-analysis was 84 %, feasibility (ALPPS stage 2 performed) 97 % (CI 94-99 %), 90-day mortality 11 % (CI 8-16 %), and complications grade IIIa or higher occured in 44 % (CI 38-50 %) of patients. A standardized reporting format for complications is lacking despite the widespread use of the Clavien-Dindo classification. Oncological outcome is not well-documented. The most common topics in the selected studies published were technical feasibility and indications for the procedures. Publication bias due to case-series and single-center reports is common. A systematic exploration of this novel operation with a rigid methodology, such as registry analyses and a randomized controlled trial, is highly advised.

Low/medium-Btu coal-gasification feasibility study

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

Not Available

1980-11-01

This study examines the feasibility of applying the concepts of Coal Gasification and Combined Cycle Technology to the re-powering of existing steam turbine-electric generating facilities. The primary objectives of this study include: (1) the determination of the feasibility of designing a technically sound system embodying this technology; (2) the determination of the potential for displacing foreign oil by the project; (3) the identificaton of any constraints and/or barriers that might impede the accomplishment of such a project; and (4) the evaluation of the potential benefits of such a system. Although the system is designed around the use of commercially available,more » state-of-the-art components and equipment, a completely integrated, electric generating plant, such as is being proposed here, has not yet been demonstrated. However, the designs developed as part of this study combine these components, utilizing well developed and technically sound concepts in such a way as to provide a reasonable degree of confidence in the workability of the total system. This study offers the potential for reducing oil dependency; the possibility of improving cycle efficiency and extending the useful life of existing facilities; the feasibility of re-vitalizing a facility located within a major load center; and presents some attractive possibilities for a co-generation, district heating application in the central portions of Bridgeport. Although the results of the study produce a number of clear conclusions, they also stimulate additional questions, the resolution of which would require further study and more detailed design. The final resolution of these questions that still remain may have a significant effect on the final conclusions concerning the viability of this project, and it is for this reason that further study is required.« less

Three Affliated Tribes Renewable Energy Feasibility Study

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

Belvin Pete; Kent Good; Krista Gordon

2006-05-26

The Three Affliated Tribes on the Fort Berthold Reservation studied the feasibility of a commercial wind facility on land selected and owned by the Tribes and examined the potential for the development of renewable energy resources on Tribal Lands.

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

The feasibility, safety and outcomes of laparoscopic re-operation for achalasia.

PubMed

James, David R C; Purkayastha, Sanjay; Aziz, Omer; Amygdalos, Iakovos; Darzi, Ara W; Hanna, George B; Zacharakis, Emmanouil

2012-05-01

Heller myotomy for achalasia is associated with a recurrence rate of around 10%, thus reoperative surgery is often necessitated. This paper aims to review the available literature on laparoscopic reoperation for achalasia in order to assess its feasibility and effectiveness. A Medline, Embase, Ovid, Cochrane database and Google(TM) Scholar search was performed with the following Mesh terms: "laparoscopic", "redo", "reoperative", "Heller's", "esophagomyotomy" and "achalasia". Outcomes of interest included patient demographics and details of primary procedure, operative details, intra- and post operative complications and symptom scores. Seven studies reported outcomes from 54 cases. Conversion occurred in 7% (4/54) of cases. Thirteen percent (7/54) of patients sustained intra-operative gastric or oesophageal perforation; however these were all noted and repaired intra-operatively leading to no subsequent morbidity. No deaths were reported. Pre- and post operative symptom scores were heterogeneous, however did appear to improve after the procedure. This review demonstrates that laparoscopic reoperation for achalasia is feasible and safe with complication rates comparable to the primary laparoscopic operation. It is recommended that laparoscopic reoperative Heller's myotomy should only be performed by surgeons with special interest in oesophagogastric surgery and adequate experience in laparoscopic surgery for achalasia.

A behavioral medicine intervention for older women living alone with chronic pain - a feasibility study.

PubMed

Cederbom, Sara; Rydwik, Elisabeth; Söderlund, Anne; Denison, Eva; Frändin, Kerstin; von Heideken Wågert, Petra

2014-01-01

To be an older woman, live alone, have chronic pain, and be dependent on support are all factors that may have an impact on daily life. One way to promote ability in everyday activities in people with pain-related conditions is to use individualized, integrated behavioral medicine in physical therapy interventions. How this kind of intervention works for older women living alone at home, with chronic pain, and dependent on formal care to manage their everyday lives has not been studied. The aim was to explore the feasibility of a study and to evaluate an individually tailored integrated behavioral medicine in physical therapy intervention for the target group of women. The study was a 12-week randomized trial with two-group design. Primary effect outcomes were pain-related disability and morale. Secondary effect outcomes focused on pain-related beliefs, self-efficacy for exercise, concerns of falling, physical activity, and physical performance. In total, 23 women agreed to participate in the study and 16 women completed the intervention. The results showed that the behavioral medicine in physical therapy intervention was feasible. No effects were seen on the primary effect outcomes. The experimental intervention seemed to improve the level of physical activity and self-efficacy for exercise. Some of the participants in both groups perceived that they could manage their everyday life in a better way after participation in the study. Results from this study are encouraging, but the study procedure and interventions have to be refined and tested in a larger feasibility study to be able to evaluate the effects of these kinds of interventions on pain-related disability, pain-related beliefs, self-efficacy in everyday activities, and morale in the target group. Further research is also needed to refine and evaluate effects from individualized reminder routines, support to collect self-report data, safety procedures for balance training, and training of personnel to

Restoring effective sleep tranquility (REST): A feasibility and pilot study.

PubMed

Eakman, Aaron M; Schmid, Arlene A; Henry, Kimberly L; Rolle, Natalie R; Schelly, Catherine; Pott, Christine E; Burns, Joshua E

2017-06-01

The purpose of this pilot study was to establish the feasibility of completing a future controlled trial of a multi-component cognitive behavioral therapy for insomnia program for military veterans with sleep disturbance. This was a single-arm feasibility and pilot study. Participants were United States post-9/11 veterans with service-connected injuries, university students, and had self-reported sleep disturbances. Restoring Effective Sleep Tranquility was a multi-component cognitive behavioral therapy for insomnia intervention consisting of seven sessions of group therapy and eight 1:1 sessions delivered by occupational therapists. Feasibility and pilot indicators were process, resources, management, and scientific, including pre-post-assessments of sleep difficulties, dysfunctional sleep beliefs, participation, and pain interference. Indicators were supportive of feasibility, including reduced sleep difficulties (for example Medical Outcomes Study Sleep Measure [ t  = 3.29, p  = .02]), reduced nightmares: t  = 2.79, p  = .03; fewer dysfunctional sleep beliefs: t  = 3.63, p  = .01, and greater ability to participate in social roles: t  = -2.86, p  = .03, along with trends towards improved satisfaction with participation and reduced pain interference. The Restoring Effective Sleep Tranquility program may reduce sleep difficulties and improve participation in US veterans with service-connected injuries, and evidence indicates a controlled trial would be feasible to deliver.

Restoring effective sleep tranquility (REST): A feasibility and pilot study

PubMed Central

Schmid, Arlene A; Henry, Kimberly L; Rolle, Natalie R; Schelly, Catherine; Pott, Christine E; Burns, Joshua E

2017-01-01

Introduction The purpose of this pilot study was to establish the feasibility of completing a future controlled trial of a multi-component cognitive behavioral therapy for insomnia program for military veterans with sleep disturbance. Method This was a single-arm feasibility and pilot study. Participants were United States post-9/11 veterans with service-connected injuries, university students, and had self-reported sleep disturbances. Restoring Effective Sleep Tranquility was a multi-component cognitive behavioral therapy for insomnia intervention consisting of seven sessions of group therapy and eight 1:1 sessions delivered by occupational therapists. Feasibility and pilot indicators were process, resources, management, and scientific, including pre–post-assessments of sleep difficulties, dysfunctional sleep beliefs, participation, and pain interference. Findings Indicators were supportive of feasibility, including reduced sleep difficulties (for example Medical Outcomes Study Sleep Measure [t = 3.29, p = .02]), reduced nightmares: t = 2.79, p = .03; fewer dysfunctional sleep beliefs: t = 3.63, p = .01, and greater ability to participate in social roles: t = –2.86, p = .03, along with trends towards improved satisfaction with participation and reduced pain interference. Conclusion The Restoring Effective Sleep Tranquility program may reduce sleep difficulties and improve participation in US veterans with service-connected injuries, and evidence indicates a controlled trial would be feasible to deliver. PMID:28626295

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.

Development and test of rural pedestrian safety countermeasures

DOT National Transportation Integrated Search

1983-12-01

Prior to any promulgation by NHTSA of four model traffic regulations for rural pedestrian safety it was the objective of this study to assess, where feasible, the potential effectiveness of these regulations to prevent pedestrian accidents. The model...

Assessment of insurance incentives for safety belt usage

DOT National Transportation Integrated Search

1983-05-12

This study assesses the feasibility of insurance companies to offer incentives, in the form of premium reductions or additional benefits, which would be effective in increasing safety belt usage. The insurance types considered in this report are auto...

Numerical aerodynamic simulation facility feasibility study, executive summary

NASA Technical Reports Server (NTRS)

1979-01-01

There were three major issues examined in the feasibility study. First, the ability of the proposed system architecture to support the anticipated workload was evaluated. Second, the throughput of the computational engine (the flow model processor) was studied using real application programs. Third, the availability, reliability, and maintainability of the system were modeled. The evaluations were based on the baseline systems. The results show that the implementation of the Numerical Aerodynamic Simulation Facility, in the form considered, would indeed be a feasible project with an acceptable level of risk. The technology required (both hardware and software) either already exists or, in the case of a few parts, is expected to be announced this year.

Prospective drug safety monitoring using the UK primary-care General Practice Research Database: theoretical framework, feasibility analysis and extrapolation to future scenarios.

PubMed

Johansson, Saga; Wallander, Mari-Ann; de Abajo, Francisco J; García Rodríguez, Luis Alberto

2010-03-01

Post-launch drug safety monitoring is essential for the detection of adverse drug signals that may be missed during preclinical trials. Traditional methods of postmarketing surveillance such as spontaneous reporting have intrinsic limitations, many of which can be overcome by the additional application of structured pharmacoepidemiological approaches. However, further improvement in drug safety monitoring requires a shift towards more proactive pharmacoepidemiological methods that can detect adverse drug signals as they occur in the population. To assess the feasibility of using proactive monitoring of an electronic medical record system, in combination with an independent endpoint adjudication committee, to detect adverse events among users of selected drugs. UK General Practice Research Database (GPRD) information was used to detect acute liver disorder associated with the use of amoxicillin/clavulanic acid (hepatotoxic) or low-dose aspirin (acetylsalicylic acid [non-hepatotoxic]). Individuals newly prescribed these drugs between 1 October 2005 and 31 March 2006 were identified. Acute liver disorder cases were assessed using GPRD computer records in combination with case validation by an independent endpoint adjudication committee. Signal generation thresholds were based on the background rate of acute liver disorder in the general population. Over a 6-month period, 8148 patients newly prescribed amoxicillin/clavulanic acid and 5577 patients newly prescribed low-dose aspirin were identified. Within this cohort, searches identified 11 potential liver disorder cases from computerized records: six for amoxicillin/clavulanic acid and five for low-dose aspirin. The independent endpoint adjudication committee refined this to four potential acute liver disorder cases for whom paper-based information was requested for final case assessment. Final case assessments confirmed no cases of acute liver disorder. The time taken for this study was 18 months (6 months for

Feasibility and safety of robot-assisted thoracic surgery for lung lobectomy in patients with non-small cell lung cancer: a systematic review and meta-analysis.

PubMed

Wei, Shiyou; Chen, Minghao; Chen, Nan; Liu, Lunxu

2017-05-08

The aim of this study is to evaluate the feasibility and safety of robot-assisted thoracic surgery (RATS) lobectomy versus video-assisted thoracic surgery (VATS) for lobectomy in patients with non-small cell lung cancer (NSCLC). An electronic search of six electronic databases was performed to identify relevant comparative studies. Meta-analysis was performed by pooling the results of reported incidence of overall morbidity, mortality, prolonged air leak, arrhythmia, and pneumonia between RATS and VATS lobectomy. Subgroup analysis was also conducted based on matched and unmatched cohort studies, if possible. Relative risks (RR) with their 95% confidence intervals (CI) were calculated by means of Revman version 5.3. Twelve retrospective cohort studies were included, with a total of 60,959 patients. RATS lobectomy significantly reduced the mortality rate when compared with VATS lobectomy (RR = 0.54, 95% CI 0.38-0.77; P = 0.0006), but this was not consistent with the pooled result of six matched studies (RR = 0.12, 95% CI 0.01-1.07; P = 0.06). There was no significant difference in morbidity between the two approaches (RR = 0.97, 95% CI 0.85-1.12; P = 0.70). RATS lobectomy is a feasible and safe technique and can achieve an equivalent short-term surgical efficacy when compared with VATS, but its cost effectiveness also should be taken into consideration.

Feasibility study of robotic neural controllers

NASA Technical Reports Server (NTRS)

Magana, Mario E.

1990-01-01

The results are given of a feasibility study performed to establish if an artificial neural controller could be used to achieve joint space trajectory tracking of a two-link robot manipulator. The study is based on the results obtained by Hecht-Nielsen, who claims that a functional map can be implemented to a desired degree of accuracy with a three layer feedforward artificial neural network. Central to this study is the assumption that the robot model as well as its parameters values are known.

Animal feasibility study of an innovated splash-needle for endoscopic submucosal dissection in the upper gastrointestinal tract.

PubMed

Fujishiro, Mitsuhiro; Sugita, Noriyuki

2013-01-01

The high frequency of complications accompanying endoscopic submucosal dissection (ESD) and its complex processes suggest that the process requires improvement. The objective of the present study was to investigate the feasibility of an innovated splash-needle for ESD. An animal feasibility study with a living pig was conducted. Six resections per portion (esophagus and upper, middle, and lower thirds of the stomach) in a total of 24 resections were carried out by using an original splash-needle or an innovated splash-needle. Major innovations were a thicker part in the middle of the knife and a metal plate on the tip of the sheath to obtain more coagulation ability. Injection solution in the submucosal layer was also changed due to possible influence on the outcomes. Main outcome measurements were entire procedure time, cutting speed, and frequency of bleeding during ESD. All the 24 resections were completed without complications. Among the obtained data, only mean cutting speeds were significantly influenced by location of the simulated lesion, which revealed that ESD at the upper third was significantly quicker than that at the lower third (P = 0.01), and ESD at the esophagus was significantly slower than that at the three parts of the stomach (P < 0.01). There was no significant difference between the different knives in each variable. The innovated splash-needle will be feasible for human use, although the safety and advantages in clinical settings must be elucidated by proper comparative studies with existing knives in humans. © 2012 The Authors. Digestive Endoscopy © 2012 Japan Gastroenterological Endoscopy Society.

Artemis: Results of the engineering feasibility study

NASA Technical Reports Server (NTRS)

1991-01-01

Information is given in viewgraph form for the Engineering Feasibility Study of the Artemis Project, a plan to establish a permanent base on the Moon. Topics covered include the Common Lunar Lander (CLL), lunar lander engineering study results, lunar lander trajectory analysis, lunar lander conceptual design and mass properties, the lunar lander communication subsystem design, and product assurance.

Improving safety culture through the health and safety organization: a case study.

PubMed

Nielsen, Kent J

2014-02-01

International research indicates that internal health and safety organizations (HSO) and health and safety committees (HSC) do not have the intended impact on companies' safety performance. The aim of this case study at an industrial plant was to test whether the HSO can improve company safety culture by creating more and better safety-related interactions both within the HSO and between HSO members and the shop-floor. A quasi-experimental single case study design based on action research with both quantitative and qualitative measures was used. Based on baseline mapping of safety culture and the efficiency of the HSO three developmental processes were started aimed at the HSC, the whole HSO, and the safety representatives, respectively. Results at follow-up indicated a marked improvement in HSO performance, interaction patterns concerning safety, safety culture indicators, and a changed trend in injury rates. These improvements are interpreted as cultural change because an organizational double-loop learning process leading to modification of the basic assumptions could be identified. The study provides evidence that the HSO can improve company safety culture by focusing on safety-related interactions. © 2013. Published by Elsevier Ltd and National Safety Council.

Home administration of maintenance pemetrexed for patients with advanced non-squamous non-small cell lung cancer: rationale, practicalities and phase II feasibility study design.

PubMed

Lal, Rohit; Bourayou, Nawel; Hillerdal, Gunnar; Nicolson, Marianne; Vikstrom, Anders; Lorenzo, Maria; D'yachkova, Yulia; Barriga, Susana; Visseren-Grul, Carla

2013-10-03

Home-based care in oncology is mainly reserved for patients at the end of life. Regulations regarding home delivery of cytotoxics differ across Europe, with a notable lack of practice guidelines in most countries. This has led to a lack of data addressing the feasibility of home-based administration of cytotoxic chemotherapy. In advanced non-squamous non-small cell lung cancer, pemetrexed is approved as maintenance therapy after first-line chemotherapy. In this setting, patients have the potential to be treated long-term with maintenance therapy, which, in the absence of unacceptable toxicity, is continued until disease progression. The favourable safety profile of pemetrexed and the ease of its administration by 10-minute intravenous infusion every 3 weeks make this drug a suitable candidate for administration in a home setting. Literature and regulations relevant to the home-based delivery of cytotoxic therapy were reviewed, and a phase II feasibility study of home administration of pemetrexed maintenance therapy was designed. At least 50 patients with advanced non-squamous non-small cell lung cancer, Eastern Cooperative Oncology Group performance status 0-1 and no progressive disease after four cycles of platinum-based first-line therapy are required to allow investigation of the feasibility of home-based administration of pemetrexed maintenance therapy (500 mg/m(2) every 3 weeks until progressive disease or unacceptable toxicity). Feasibility is being assessed as adherence to the home-based administration process (primary endpoint), patient safety, impact on patients' quality of life, patient and physician satisfaction with home care, and healthcare resource use and costs. Enrolment of patients from the UK and Sweden, where home-based care is relatively well developed, commenced in December 2011. This feasibility study addresses an important aspect of maintenance therapy, that is, patient comfort during protracted home-based chemotherapy. The study design

Home administration of maintenance pemetrexed for patients with advanced non-squamous non-small cell lung cancer: rationale, practicalities and phase II feasibility study design

PubMed Central

2013-01-01

Background Home-based care in oncology is mainly reserved for patients at the end of life. Regulations regarding home delivery of cytotoxics differ across Europe, with a notable lack of practice guidelines in most countries. This has led to a lack of data addressing the feasibility of home-based administration of cytotoxic chemotherapy. In advanced non-squamous non-small cell lung cancer, pemetrexed is approved as maintenance therapy after first-line chemotherapy. In this setting, patients have the potential to be treated long-term with maintenance therapy, which, in the absence of unacceptable toxicity, is continued until disease progression. The favourable safety profile of pemetrexed and the ease of its administration by 10-minute intravenous infusion every 3 weeks make this drug a suitable candidate for administration in a home setting. Methods Literature and regulations relevant to the home-based delivery of cytotoxic therapy were reviewed, and a phase II feasibility study of home administration of pemetrexed maintenance therapy was designed. At least 50 patients with advanced non-squamous non-small cell lung cancer, Eastern Cooperative Oncology Group performance status 0–1 and no progressive disease after four cycles of platinum-based first-line therapy are required to allow investigation of the feasibility of home-based administration of pemetrexed maintenance therapy (500 mg/m2 every 3 weeks until progressive disease or unacceptable toxicity). Feasibility is being assessed as adherence to the home-based administration process (primary endpoint), patient safety, impact on patients’ quality of life, patient and physician satisfaction with home care, and healthcare resource use and costs. Enrolment of patients from the UK and Sweden, where home-based care is relatively well developed, commenced in December 2011. Discussion This feasibility study addresses an important aspect of maintenance therapy, that is, patient comfort during protracted home

Transit Feasibility Study Guilford Courthouse National Military Park.

DOT National Transportation Integrated Search

2009-02-28

This study is intended to be a broad overview of the transit feasibility at Guilford Courthouse NMP. The study will discuss the project background and context, and outline the two options for transit service. A detailed evaluation of costs and benefi...

Flight Performance Feasibility Studies for the Max Launch Abort System

NASA Technical Reports Server (NTRS)

Tarabini, Paul V.; Gilbert, Michael G.; Beaty, James R.

2013-01-01

In 2007, the NASA Engineering and Safety Center (NESC) initiated the Max Launch Abort System Project to explore crew escape system concepts designed to be fully encapsulated within an aerodynamic fairing and smoothly integrated onto a launch vehicle. One objective of this design was to develop a more compact launch escape vehicle that eliminated the need for an escape tower, as was used in the Mercury and Apollo escape systems and what is planned for the Orion Multi-Purpose Crew Vehicle (MPCV). The benefits for the launch vehicle of eliminating a tower from the escape vehicle design include lower structural weights, reduced bending moments during atmospheric flight, and a decrease in induced aero-acoustic loads. This paper discusses the development of encapsulated, towerless launch escape vehicle concepts, especially as it pertains to the flight performance and systems analysis trade studies conducted to establish mission feasibility and assess system-level performance. Two different towerless escape vehicle designs are discussed in depth: one with allpropulsive control using liquid attitude control thrusters, and a second employing deployable aft swept grid fins to provide passive stability during coast. Simulation results are presented for a range of nominal and off-nominal escape conditions.

The role of the Data and Safety Monitoring Board in a clinical trial: the CRISIS study.

PubMed

Holubkov, Richard; Casper, T Charles; Dean, J Michael; Anand, K J S; Zimmerman, Jerry; Meert, Kathleen L; Newth, Christopher J L; Berger, John; Harrison, Rick; Willson, Douglas F; Nicholson, Carol

2013-05-01

Randomized clinical trials are commonly overseen by a Data and Safety Monitoring Board comprised of experts in medicine, ethics, and biostatistics. Data and Safety Monitoring Board responsibilities include protocol approval, interim review of study enrollment, protocol compliance, safety, and efficacy data. Data and Safety Monitoring Board decisions can affect study design and conduct, as well as reported findings. Researchers must incorporate Data and Safety Monitoring Board oversight into the design, monitoring, and reporting of randomized trials. Case study, narrative review. The Data and Safety Monitoring Board's role during the comparative pediatric Critical Illness Stress-Induced Immune Suppression (CRISIS) Prevention Trial is described. The National Institutes of Health-appointed CRISIS Data and Safety Monitoring Board was charged with monitoring sample size adequacy and feasibility, safety with respect to adverse events and 28-day mortality, and efficacy with respect to the primary nosocomial infection/sepsis outcome. The Federal Drug Administration also requested Data and Safety Monitoring Board interim review before opening CRISIS to children below 1 yr of age. The first interim analysis found higher 28-day mortality in one treatment arm. The Data and Safety Monitoring Board maintained trial closure to younger children and requested a second interim data review 6 months later. At this second meeting, mortality was no longer of concern, whereas a weak efficacy trend of lower infection/sepsis rates in one study arm emerged. As over 40% of total patients had been enrolled, the Data and Safety Monitoring Board elected to examine conditional power and unmask treatment arm identities. On finding somewhat greater efficacy in the placebo arm, the Data and Safety Monitoring Board recommended stopping CRISIS due to futility. The design and operating procedures of a multicenter randomized trial must consider a pivotal Data and Safety Monitoring Board role. Maximum

Final Technical Report: Renewable Energy Feasibility Study and Resources Assessment

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

Rivero, Mariah

In March 2011, the U.S. Department of Energy (DOE) awarded White Pine County, Nevada, a grant to assess the feasibility of renewable resource-related economic development activities in the area. The grant project included a public outreach and training component and was to include a demonstration project; however, the demonstration project was not completed due to lack of identification of an entity willing to locate a project in White Pine County. White Pine County completed the assessment of renewable resources and a feasibility study on the potential for a renewable energy-focused economic sector within the County. The feasibility study concluded "allmore » resources studied were present and in sufficient quantity and quality to warrant consideration for development" and there were varying degrees of potential economic impact based on the resource type and project size. The feasibility study and its components were to be used as tools to attract potential developers and other business ventures to the local market. White Pine County also marketed the County’s resources to the renewable energy business community in an effort to develop contracts for demonstration projects. The County also worked to develop partnerships with local educational institutions, including the White Pine County School District, conducted outreach and training for the local community.« less

NTRE extended life feasibility assessment

NASA Technical Reports Server (NTRS)

1993-01-01

Results of a feasibility analysis of a long life, reusable nuclear thermal rocket engine are presented in text and graph form. Two engine/reactor concepts are addressed: the Particle Bed Reactor (PBR) design and the Commonwealth of Independent States (CIS) concept. Engine design, integration, reliability, and safety are addressed by various members of the NTRE team from Aerojet Propulsion Division, Energopool (Russia), and Babcock & Wilcox.

Remote Manipulator System (RMS)-based Controls-Structures Interaction (CSI) flight experiment feasibility study

NASA Technical Reports Server (NTRS)

Demeo, Martha E.

1990-01-01

The feasibility of an experiment which will provide an on-orbit validation of Controls-Structures Interaction (CSI) technology, was investigated. The experiment will demonstrate the on-orbit characterization and flexible-body control of large flexible structure dynamics using the shuttle Remote Manipulator System (RMS) with an attached payload as a test article. By utilizing existing hardware as well as establishing integration, operation and safety algorithms, techniques and procedures, the experiment will minimize the costs and risks of implementing a flight experiment. The experiment will also offer spin-off enhancement to both the Shuttle RMS (SRMS) and the Space Station RMS (SSRMS).

Laparoscopic cholecystectomy in acute gallstone pancreatitis in index hospital admission: feasibility and safety.

PubMed

Sangrasi, Ahmed Khan; Syed, Bm; Memon, Amir Iqbal; Laghari, Abdul Aziz; Talpur, K Altaf Hussain; Qureshi, Jawaid Naeem

2014-05-01

Acute gallstone pancreatitis is quite common throughout the globe. Conventionally definitive cholecystectomy has been delayed in index hospital admission. Since the last decade timing of cholecystectomy is gradually shifting towards the earlier phase of disease and currently gallstone pancreatitis is being evaluated as a further indication for laparoscopic cholecystectomy. There is also great concern regarding compliance of patients for definitive surgery due to poverty, ignorance and illiteracy in developing countries. The aim of this study was to assess the feasibility and safety of laparoscopic cholecystectomy as a definitive treatment in patients with mild and resolving gall stone pancreatitis. This was a prospective study from July 2009 to June 2012. Patients were diagnosed by clinical examination, biochemical tests, ultrasonography and contrast enhanced CT. Patients with mild form of the disease (Ranson Score ≤3) and who showed clinical improvement were offered laparoscopic cholecystectomy in index hospital admission. Those who were unfit for surgery were referred for endoscopic sphincterotomy. Common bile duct stones were excluded preoperatively. A total of 38 patients were admitted with acute gallstone pancreatitis in the study period. The mean age of patients was 46.3 years with male to female ratio of 11/27. 22 (57.8%) patients were selected for laparoscopic cholecystectomy and procedure was completed successfully. Ten (26.3%) patients were referred for ERCP and endoscopic sphincterotomy and 11 (28.9%) were managed by conservative treatment and went without any definitive treatment. Mean duration of time from onset of symptoms and laparoscopic cholecystectomy was 7 days (range 4-10). Mean duration of operative time was 45 minutes and hospital stay was 7 days. There was no operative mortality. No major intra-operative or post-operative complication was recorded. two patients (9%) had minor complications. Laparoscopic cholecystectomy can be safely

Safety and Feasibility of Long-term Intravenous Sodium Nitrite Infusion in Healthy Volunteers

PubMed Central

Pluta, Ryszard M.; Oldfield, Edward H.; Bakhtian, Kamran D.; Fathi, Ali Reza; Smith, René K.; DeVroom, Hetty L.; Nahavandi, Masoud; Woo, Sukyung; Figg, William D.; Lonser, Russell R.

2011-01-01

Background Infusion of sodium nitrite could provide sustained therapeutic concentrations of nitric oxide (NO) for the treatment of a variety of vascular disorders. The study was developed to determine the safety and feasibility of prolonged sodium nitrite infusion. Methodology Healthy volunteers, aged 21 to 60 years old, were candidates for the study performed at the National Institutes of Health (NIH; protocol 05-N-0075) between July 2007 and August 2008. All subjects provided written consent to participate. Twelve subjects (5 males, 7 females; mean age, 38.8±9.2 years (range, 21–56 years)) were intravenously infused with increasing doses of sodium nitrite for 48 hours (starting dose at 4.2 µg/kg/hr; maximal dose of 533.8 µg/kg/hr). Clinical, physiologic and laboratory data before, during and after infusion were analyzed. Findings The maximal tolerated dose for intravenous infusion of sodium nitrite was 267 µg/kg/hr. Dose limiting toxicity occurred at 446 µg/kg/hr. Toxicity included a transient asymptomatic decrease of mean arterial blood pressure (more than 15 mmHg) and/or an asymptomatic increase of methemoglobin level above 5%. Nitrite, nitrate, S-nitrosothiols concentrations in plasma and whole blood increased in all subjects and returned to preinfusion baseline values within 12 hours after cessation of the infusion. The mean half-life of nitrite estimated at maximal tolerated dose was 45.3 minutes for plasma and 51.4 minutes for whole blood. Conclusion Sodium nitrite can be safely infused intravenously at defined concentrations for prolonged intervals. These results should be valuable for developing studies to investigate new NO treatment paradigms for a variety of clinical disorders, including cerebral vasospasm after subarachnoid hemorrhage, and ischemia of the heart, liver, kidney and brain, as well as organ transplants, blood-brain barrier modulation and pulmonary hypertension. Clinical Trial Registration Information http

Clinical feasibility of interactive motion-controlled games for stroke rehabilitation.

PubMed

Bower, Kelly J; Louie, Julie; Landesrocha, Yoseph; Seedy, Paul; Gorelik, Alexandra; Bernhardt, Julie

2015-08-02

Active gaming technologies, including the Nintendo Wii and Xbox Kinect, have become increasingly popular for use in stroke rehabilitation. However, these systems are not specifically designed for this purpose and have limitations. The aim of this study was to investigate the feasibility of using a suite of motion-controlled games in individuals with stroke undergoing rehabilitation. Four games, which utilised a depth-sensing camera (PrimeSense), were developed and tested. The games could be played in a seated or standing position. Three games were controlled by movement of the torso and one by upper limb movement. Phase 1 involved consecutive recruitment of 40 individuals with stroke who were able to sit unsupported. Participants were randomly assigned to trial one game during a single session. Sixteen individuals from Phase 1 were recruited to Phase 2. These participants were randomly assigned to an intervention or control group. Intervention participants performed an additional eight sessions over four weeks using all four game activities. Feasibility was assessed by examining recruitment, adherence, acceptability and safety in both phases of the study. Forty individuals (mean age 63 years) completed Phase 1, with an average session time of 34 min. The majority of Phase 1 participants reported the session to be enjoyable (93 %), helpful (80 %) and something they would like to include in their therapy (88 %). Sixteen individuals (mean age 61 years) took part in Phase 2, with an average of seven 26-min sessions over four weeks. Reported acceptability was high for the intervention group and improvements over time were seen in several functional outcome measures. There were no serious adverse safety events reported in either phase of the study; however, a number of participants reported minor increases in pain. A post-stroke intervention using interactive motion-controlled games shows promise as a feasible and potentially effective treatment approach. This paper

Safety and feasibility of the robotic platform in the management of surgical sequelae of chronic pancreatitis.

PubMed

Hamad, Ahmad; Zenati, Mazen S; Nguyen, Trang K; Hogg, Melissa E; Zeh, Herbert J; Zureikat, Amer H

2018-02-01

The application of minimally invasive surgery to chronic pancreatitis (CP) procedures is uncommon. Our objective was to report the safety and feasibility of the robotic approach in the treatment of surgical sequelae of CP, and provide insights into the technique, tricks, and pitfalls associated with the application of robotics to this challenging disease entity. A retrospective review of a prospectively maintained database of patients undergoing robotic-assisted resections and/or drainage procedures for CP at the University of Pittsburgh between May 2009 and January 2017 was performed. A video of a robotic Frey procedure is also shown. Of 812 robotic pancreatic resections and reconstructions 39 were for CP indications. These included 11 total pancreatectomies [with and without auto islet transplantation], 8 Puestow procedures, 4 Frey procedures, 6 pancreaticoduodenectomies, and 10 distal pancreatectomies. Median age was 49, and 41% of the patients were female. The most common etiology for CP was idiopathic pancreatitis (n = 16, 46%). Median operative time was 324 min with a median estimated blood loss of 250 ml. None of the patients required conversion to laparotomy. A Clavien III-IV complication rate was experienced by 5 (13%) patients, including one reoperation. Excluding the eleven patients who underwent TP, rate of clinically relevant postoperative pancreatic fistula was 7% (Grade B = 2, Grade C = 0). No 30 or 90 day mortalities were recorded. The median length of hospital stay was 7 days. Use of the robotic platform is safe and feasible when tackling complex pancreatic resections for sequelae of chronic pancreatitis.

Predictive Hyperglycemia and Hypoglycemia Minimization: In-Home Evaluation of Safety, Feasibility, and Efficacy in Overnight Glucose Control in Type 1 Diabetes.

PubMed

Spaic, Tamara; Driscoll, Marsha; Raghinaru, Dan; Buckingham, Bruce A; Wilson, Darrell M; Clinton, Paula; Chase, H Peter; Maahs, David M; Forlenza, Gregory P; Jost, Emily; Hramiak, Irene; Paul, Terri; Bequette, B Wayne; Cameron, Faye; Beck, Roy W; Kollman, Craig; Lum, John W; Ly, Trang T

2017-03-01

The objective of this study was to determine the safety, feasibility, and efficacy of a predictive hyperglycemia and hypoglycemia minimization (PHHM) system compared with predictive low-glucose insulin suspension (PLGS) alone in overnight glucose control. A 42-night trial was conducted in 30 individuals with type 1 diabetes in the age range 15-45 years. Participants were randomly assigned each night to either PHHM or PLGS and were blinded to the assignment. The system suspended the insulin pump on both the PHHM and PLGS nights for predicted hypoglycemia but delivered correction boluses for predicted hyperglycemia on PHHM nights only. The primary outcome was the percentage of time spent in a sensor glucose range of 70-180 mg/dL during the overnight period. The addition of automated insulin delivery with PHHM increased the time spent in the target range (70-180 mg/dL) from 71 ± 10% during PLGS nights to 78 ± 10% during PHHM nights ( P < 0.001). The average morning blood glucose concentration improved from 163 ± 23 mg/dL after PLGS nights to 142 ± 18 mg/dL after PHHM nights ( P < 0.001). Various sensor-measured hypoglycemic outcomes were similar on PLGS and PHHM nights. All participants completed 42 nights with no episodes of severe hypoglycemia, diabetic ketoacidosis, or other study- or device-related adverse events. The addition of a predictive hyperglycemia minimization component to our existing PLGS system was shown to be safe, feasible, and effective in overnight glucose control. © 2017 by the American Diabetes Association.

Working towards consensus on methods used to elicit participant-reported safety data in uncomplicated malaria clinical drug studies: a Delphi technique study.

PubMed

Mandimika, Nyaradzo; Barnes, Karen I; Chandler, Clare I R; Pace, Cheryl; Allen, Elizabeth N

2017-01-28

Eliciting adverse event (AE) and non-study medication data reports from clinical research participants is integral to evaluating drug safety. However, using different methods to question participants yields inconsistent results, compromising the interpretation, comparison and pooling of data across studies. This is particularly important given the widespread use of anti-malarials in vulnerable populations, and their increasing use in healthy, but at-risk individuals, as preventive treatment or to reduce malaria transmission. Experienced and knowledgeable anti-malarial drug clinical researchers were invited to participate in a Delphi technique study, to facilitate consensus on what are considered optimal (relevant, important and feasible) methods, tools, and approaches for detecting participant-reported AE and non-study medication data in uncomplicated malaria treatment studies. Of 72 invited, 25, 16 and 10 panellists responded to the first, second and third rounds of the Delphi, respectively. Overall, 68% (68/100) of all questioning items presented for rating achieved consensus. When asking general questions about health, panellists agreed on the utility of a question/concept about any change in health, taking care to ensure that such questions/concepts do not imply causality. Eighty-nine percent (39/44) of specific signs and symptoms questions were rated as optimal. For non-study medications, a general question and most structured questioning items were considered an optimal approach. The use of mobile phones, patient diaries, rating scales as well as openly engaging with participants to discuss concerns were also considered optimal complementary data-elicitation tools. This study succeeded in reaching consensus within a section of the anti-malarial drug clinical research community about using a general question concept, and structured questions for eliciting data about AEs and non-study medication reports. The concepts and items considered in this Delphi to be

Space shuttle program information control and retrieval system feasibility study report

NASA Technical Reports Server (NTRS)

Lingle, C. P.

1973-01-01

The feasibility of having a common information management network for space shuttle data, is studied. Identified are the information types required, sources and users of the information, and existing techniques for acquiring, storing and retrieving the data. The study concluded that a decentralized system is feasible, and described a recommended development plan for it.

A rough set-based measurement model study on high-speed railway safety operation.

PubMed

Hu, Qizhou; Tan, Minjia; Lu, Huapu; Zhu, Yun

2018-01-01

Aiming to solve the safety problems of high-speed railway operation and management, one new method is urgently needed to construct on the basis of the rough set theory and the uncertainty measurement theory. The method should carefully consider every factor of high-speed railway operation that realizes the measurement indexes of its safety operation. After analyzing the factors that influence high-speed railway safety operation in detail, a rough measurement model is finally constructed to describe the operation process. Based on the above considerations, this paper redistricts the safety influence factors of high-speed railway operation as 16 measurement indexes which include staff index, vehicle index, equipment index and environment. And the paper also provides another reasonable and effective theoretical method to solve the safety problems of multiple attribute measurement in high-speed railway operation. As while as analyzing the operation data of 10 pivotal railway lines in China, this paper respectively uses the rough set-based measurement model and value function model (one model for calculating the safety value) for calculating the operation safety value. The calculation result shows that the curve of safety value with the proposed method has smaller error and greater stability than the value function method's, which verifies the feasibility and effectiveness.

Teleretinal screening for diabetic retinopathy in six Los Angeles urban safety-net clinics: final study results.

PubMed

Ogunyemi, Omolola; George, Sheba; Patty, Lauren; Teklehaimanot, Senait; Baker, Richard

2013-01-01

In a previous paper, we presented initial findings from a study on the feasibility and challenges of implementing teleretinal screening for diabetic retinopathy in an urban safety net setting facing eyecare specialist shortages. This paper presents some final results from that study, which involved six South Los Angeles safety net clinics. A total of 2,732 unique patients were screened for diabetic retinopathy by three ophthalmologist readers, with 1035 receiving a recommendation for referral to specialty care. Referrals included 48 for proliferative diabetic retinopathy, 115 for severe non-proliferative diabetic retinopathy (NPDR), 247 for moderate NPDR, 246 for mild NPDR, 97 for clinically significant macular edema, and 282 for a non-diabetic condition, such as glaucoma. Image quality was also assessed, with ophthalmologist readers grading 4% to 13% of retinal images taken at the different clinics as being inadequate for any diagnostic interpretation.

Commercial-off-the-shelf (COTS) hardware and software for train control applications : system safety considerations.

DOT National Transportation Integrated Search

2003-04-01

The objective of this study was to assess the feasibility of using commercial off-the-shelf(COTS)processor-based systems for safety- related railroad applications. From the safety perspective,the fundamental challenges of using COTS products are most...

Feasibility of new simulation technology to train novice drivers

DOT National Transportation Integrated Search

1996-12-01

This project examined the feasibility of using existing simulation and other electronic device technology with the potential for the safety training of novice drivers. Project activities included: a literature review; site visits and telephone inquir...

21 CFR 601.93 - Postmarketing safety reporting.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 7 2013-04-01 2013-04-01 false Postmarketing safety reporting. 601.93 Section 601.93 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) BIOLOGICS LICENSING Approval of Biological Products When Human Efficacy Studies Are Not Ethical or Feasible...

21 CFR 314.630 - Postmarketing safety reporting.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 314.630 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG Approval of New Drugs When Human Efficacy Studies Are Not Ethical or Feasible § 314.630 Postmarketing safety reporting. Drug...

21 CFR 601.93 - Postmarketing safety reporting.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 7 2012-04-01 2012-04-01 false Postmarketing safety reporting. 601.93 Section 601.93 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) BIOLOGICS LICENSING Approval of Biological Products When Human Efficacy Studies Are Not Ethical or Feasible...

21 CFR 314.630 - Postmarketing safety reporting.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 314.630 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG Approval of New Drugs When Human Efficacy Studies Are Not Ethical or Feasible § 314.630 Postmarketing safety reporting. Drug...

21 CFR 601.93 - Postmarketing safety reporting.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 7 2010-04-01 2010-04-01 false Postmarketing safety reporting. 601.93 Section 601.93 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) BIOLOGICS LICENSING Approval of Biological Products When Human Efficacy Studies Are Not Ethical or Feasible...

21 CFR 314.630 - Postmarketing safety reporting.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 314.630 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG Approval of New Drugs When Human Efficacy Studies Are Not Ethical or Feasible § 314.630 Postmarketing safety reporting. Drug...

21 CFR 314.630 - Postmarketing safety reporting.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 314.630 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG Approval of New Drugs When Human Efficacy Studies Are Not Ethical or Feasible § 314.630 Postmarketing safety reporting. Drug...

21 CFR 314.630 - Postmarketing safety reporting.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 314.630 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG Approval of New Drugs When Human Efficacy Studies Are Not Ethical or Feasible § 314.630 Postmarketing safety reporting. Drug...

21 CFR 601.93 - Postmarketing safety reporting.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 7 2011-04-01 2010-04-01 true Postmarketing safety reporting. 601.93 Section 601.93 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) BIOLOGICS LICENSING Approval of Biological Products When Human Efficacy Studies Are Not Ethical or Feasible...

21 CFR 601.93 - Postmarketing safety reporting.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 7 2014-04-01 2014-04-01 false Postmarketing safety reporting. 601.93 Section 601.93 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) BIOLOGICS LICENSING Approval of Biological Products When Human Efficacy Studies Are Not Ethical or Feasible...

Conducting feasibilities in clinical trials: an investment to ensure a good study.

PubMed

Rajadhyaksha, Viraj

2010-07-01

Conducting clinical trial feasibility is one of the first steps in clinical trial conduct. This process includes assessing internal and environmental capacity, alignment of the clinical trial in terms of study design, dose of investigational product, comparator, patient type, with the local environment and assessing potential of conducting clinical trial in a specific country. A robust feasibility also ensures a realistic assessment and capability to conduct the clinical trial. For local affiliates of pharmaceutical organizations, and contract research organizations, this is a precursor to study placement and influences the decision of study placement. This article provides details on different types of feasibilities, information which is to be included and relevance of each. The article also aims to provide practical hands-on suggestions to make feasibilities more realistic and informative.

Feasibility of space disposal of radioactive nuclear waste. 2: Technical summary

NASA Technical Reports Server (NTRS)

1974-01-01

The feasibility of transporting radioactive waste produced in the process of generating electricity in nuclear powerplants into space for ultimate disposal was investigated at the request of the AEC as a NASA in-house effort. The investigation is part of a broad AEC study of methods for long-term storage or disposal of radioactive waste. The results of the study indicate that transporting specific radioactive wastes, particularly the actinides with very long half-lives, into space using the space shuttle/tug as the launch system, appears feasible from the engineering and safety viewpoints. The space transportation costs for ejecting the actinides out of the solar system would represent less than a 5-percent increase in the average consumer's electric bill.

A behavioral medicine intervention for older women living alone with chronic pain – a feasibility study

PubMed Central

Cederbom, Sara; Rydwik, Elisabeth; Söderlund, Anne; Denison, Eva; Frändin, Kerstin; von Heideken Wågert, Petra

2014-01-01

Background To be an older woman, live alone, have chronic pain, and be dependent on support are all factors that may have an impact on daily life. One way to promote ability in everyday activities in people with pain-related conditions is to use individualized, integrated behavioral medicine in physical therapy interventions. How this kind of intervention works for older women living alone at home, with chronic pain, and dependent on formal care to manage their everyday lives has not been studied. The aim was to explore the feasibility of a study and to evaluate an individually tailored integrated behavioral medicine in physical therapy intervention for the target group of women. Materials and methods The study was a 12-week randomized trial with two-group design. Primary effect outcomes were pain-related disability and morale. Secondary effect outcomes focused on pain-related beliefs, self-efficacy for exercise, concerns of falling, physical activity, and physical performance. Results In total, 23 women agreed to participate in the study and 16 women completed the intervention. The results showed that the behavioral medicine in physical therapy intervention was feasible. No effects were seen on the primary effect outcomes. The experimental intervention seemed to improve the level of physical activity and self-efficacy for exercise. Some of the participants in both groups perceived that they could manage their everyday life in a better way after participation in the study. Conclusion Results from this study are encouraging, but the study procedure and interventions have to be refined and tested in a larger feasibility study to be able to evaluate the effects of these kinds of interventions on pain-related disability, pain-related beliefs, self-efficacy in everyday activities, and morale in the target group. Further research is also needed to refine and evaluate effects from individualized reminder routines, support to collect self-report data, safety procedures for

School Safety Study: Phase I.

ERIC Educational Resources Information Center

Arora, Alka

This report summarizes findings from a study concerned with Arizona school safety. The survey component highlights safety-related policy information across 300 schools; the interview component highlights school-safety perceptions of 64 staff across 16 schools. Various policies and programs that respond to internal and external threats to school…

Feasibility of a home-delivered Internet obesity prevention program for fourth-grade students.

PubMed

Owens, Scott; Lambert, Laurel; McDonough, Suzanne; Green, Kenneth; Loftin, Mark

2009-08-01

This pilot study examined the feasibility of an interactive obesity prevention program delivered to a class of fourth-grade students utilizing daily e-mail messages sent to the students' home computers. The study involved a single intact class of 22 students, 17 (77%) of whom submitted parental permission documentation and received e-mail messages each school day over the course of one month. Concerns regarding Internet safety and children's use of e-mail were addressed fairly easily. Cost/benefit issues for the school did not seem prohibitive. Providing e-mail access to students without a home computer was accomplished by loaning them personal digital assistant (PDA) devices. In larger interventions, loaning PDAs is probably not feasible economically, although cell phones may be an acceptable alternative. It was concluded that this type of interactive obesity prevention program is feasible from most perspectives. Data from a larger scale effectiveness study is still needed.

43 CFR 404.18 - How can I request assistance to conduct a feasibility study?

Code of Federal Regulations, 2011 CFR

2011-10-01

... feasibility study? 404.18 Section 404.18 Public Lands: Interior Regulations Relating to Public Lands BUREAU OF... request assistance to conduct a feasibility study? To request assistance to conduct a feasibility study under § 404.11(a) or (b), consistent with Reclamation's recommendation in an appraisal report, you must...

Feasibility Study of a Satellite Solar Power Station

NASA Technical Reports Server (NTRS)

Glaser, P. E.; Maynard, O. E.; Mackovciak, J. J. R.; Ralph, E. I.

1974-01-01

A feasibility study of a satellite solar power station (SSPS) was conducted to: (1) explore how an SSPS could be flown and controlled in orbit; (2) determine the techniques needed to avoid radio frequency interference (RFI); and (3) determine the key environmental, technological, and economic issues involved. Structural and dynamic analyses of the SSPS structure were performed, and deflections and internal member loads were determined. Desirable material characteristics were assessed and technology developments identified. Flight control performance of the SSPS baseline design was evaluated and parametric sizing studies were performed. The study of RFI avoidance techniques covered (1) optimization of the microwave transmission system; (2) device design and expected RFI; and (3) SSPS RFI effects. The identification of key issues involved (1) microwave generation, transmissions, and rectification and solar energy conversion; (2) environmental-ecological impact and biological effects; and (3) economic issues, i.e., costs and benefits associated with the SSPS. The feasibility of the SSPS based on the parameters of the study was established.

Feasibility and safety of exercise stress testing using an anti-gravity treadmill with Tc-99m tetrofosmin single-photon emission computed tomography (SPECT) myocardial perfusion imaging: A pilot non-randomized controlled study.

PubMed

Daly, Patrick; Kayse, Regina; Rudick, Steven; Robbins, Nathan; Scheler, Jennifer; Harris, David; O'Donnell, Robert; Dwivedi, Alok K; Gerson, Myron C

2017-08-31

Exercise is the AHA/ACC guideline-recommended stress modality for myocardial perfusion imaging, but many patients are unable to exercise to target heart rate on a conventional treadmill. We examined the feasibility and safety of stress imaging using an anti-gravity treadmill in patients with perceived poor exercise capacity. 49 patients were recruited for stress testing by anti-gravity treadmill (n = 29) or to a regadenoson control group (n = 20). Seventeen anti-gravity test patients (59%) reached target heart rate obviating the need for a pharmacologic stress agent. Adverse effects of the anti-gravity treadmill were limited to minor muscle aches in 5 subjects. Stress myocardial perfusion image quality judged by 3 blinded readers on a 5-point scale was comparable for the anti-gravity treadmill (4.30 ± SD 0.87) vs pharmacologic stress (4.28 ± SD 0.66). Stress testing using an anti-gravity treadmill is feasible and may help some patients safely achieve target heart rate.

Cape Lookout National Seashore passenger ferry transportation feasibility study

DOT National Transportation Integrated Search

2010-09-01

The Cape Lookout National Seashore Passenger Ferry Transportation Feasibility Study is a technical study documenting the capital investment and operational considerations associated with consolidation of passenger ferry service from Harkers Island an...

Safety and feasibility for pediatric cardiac regeneration using epicardial delivery of autologous umbilical cord blood-derived mononuclear cells established in a porcine model system.

PubMed

Cantero Peral, Susana; Burkhart, Harold M; Oommen, Saji; Yamada, Satsuki; Nyberg, Scott L; Li, Xing; O'Leary, Patrick W; Terzic, Andre; Cannon, Bryan C; Nelson, Timothy J

2015-02-01

Congenital heart diseases (CHDs) requiring surgical palliation mandate new treatment strategies to optimize long-term outcomes. Despite the mounting evidence of cardiac regeneration, there are no long-term safety studies of autologous cell-based transplantation in the pediatric setting. We aimed to establish a porcine pipeline to evaluate the feasibility and long-term safety of autologous umbilical cord blood mononuclear cells (UCB-MNCs) transplanted into the right ventricle (RV) of juvenile porcine hearts. Piglets were born by caesarean section to enable UCB collection. Upon meeting release criteria, 12 animals were randomized in a double-blinded fashion prior to surgical delivery of test article (n=6) or placebo (n=6). The UCB-MNC (3×10(6) cells per kilogram) or control (dimethyl sulfoxide, 10%) products were injected intramyocardially into the RV under direct visualization. The cohorts were monitored for 3 months after product delivery with assessments of cardiac performance, rhythm, and serial cardiac biochemical markers, followed by terminal necropsy. No mortalities were associated with intramyocardial delivery of UCB-MNCs or placebo. Two animals from the placebo group developed local skin infection after surgery that responded to antibiotic treatment. Electrophysiological assessments revealed no arrhythmias in either group throughout the 3-month study. Two animals in the cell-therapy group had transient, subclinical dysrhythmia in the perioperative period, likely because of an exaggerated response to anesthesia. Overall, this study demonstrated that autologous UCB-MNCs can be safely collected and surgically delivered in a pediatric setting. The safety profile establishes the foundation for cell-based therapy directed at the RV of juvenile hearts and aims to accelerate cell-based therapies toward clinical trials for CHD. ©AlphaMed Press.

Micro-fragmented adipose tissue injection for the treatment of complex anal fistula: a pilot study accessing safety and feasibility.

PubMed

Naldini, G; Sturiale, A; Fabiani, B; Giani, I; Menconi, C

2018-02-01

The aim of the present study was to evaluate the safety and efficacy of autologous, micro-fragmented and minimally manipulated adipose tissue injection associated closure of the internal opening in promoting healing of complex anal fistula. A pilot study was conducted on patients referred to our center with anal fistula, from April 2015-December 2016. Inclusion criteria were age over 16 years old and a diagnosis of complex anal fistula according to the American Gastroenterological Association classification The patients were divided into 2 groups; the "first time group" (Group I) in which micro-fragmented adipose tissue injection with closure of the internal opening was the first sphincter-saving procedure, and the "recurrent group" (Group II) consisting of patients who had failed prior sphincter-saving procedures. The procedure was carried out 4-6 weeks after seton placement. Follow-up visits were scheduled at 7 days, and 1, 3, 6 and 12 months after surgery. Fistula healing was defined as the closure of the internal and external openings without any discharge. Out of 47 patients with complex transsphincteric anal fistula, 19 met the inclusion criteria and were selected to undergo the procedure. Twelve of these patients (Group I) had micro-fragmented adipose tissue injection as first-line treatment, and 7 (Group II) had failed previous sphincter-saving procedures. The mean operative time was 55 ± 6 min (range 50-70 min). The mean postoperative pain score measured with the visual analog pain scale was 2 ± 1.4 (range 0-4). No intraoperative difficulties related to the use of the kit were recorded. There were no cases of postoperative fever or abdominal sepsis related to the procedure and no post-treatment perianal bleeding or impaired anal continence. Only 3 cases of minor abdominal wall hematoma that did not require any treatment and 1 case of perianal abscess were observed. Patients were evaluated for a mean follow-up time of 9 ± 3.1 months (range 3

Solar pond power plant feasibility study for Davis, California

NASA Technical Reports Server (NTRS)

Wu, Y. C.; Singer, M. J.; Marsh, H. E.; Harris, J.; Walton, A. L.

1982-01-01

The feasibility of constructing a solar pond power plant at Davis, California was studied. Site visits, weather data compilation, soil and water analyses, conceptual system design and analyses, a material and equipment market survey, conceptual site layout, and a preliminary cost estimate were studied. It was concluded that a solar pond power plant is technically feasible, but economically unattractive. The relatively small scale of the proposed plant and the high cost of importing salt resulted in a disproportionately high capital investment with respect to the annual energy production capacity of the plant. Cycle optimization and increased plant size would increase the economical attractiveness of the proposed concept.

D-21B RBCC Modification Feasibility Study

NASA Technical Reports Server (NTRS)

1999-01-01

This report presents a feasibility study on the modifications required to re-engine the Lockheed D-21 Drone for use as a NASA RBCC engine. An introduction, background information, engine configuration and performance, propulsion system integration, loads/thermal analysis, avionics/systems, flight test results, costs and work schedule, and some conclusions are presented.

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

The Feasibility of Standardised Geriatric Assessment Tools and Physical Exercises in Frail Older Adults.

PubMed

Jadczak, A D; Mahajan, N; Visvanathan, R

2017-01-01

Geriatric assessment tools are applicable to the general geriatric population; however, their feasibility in frail older adults is yet to be determined. The study aimed to determine the feasibility of standardised geriatric assessment tools and physical exercises in hospitalised frail older adults. Various assessment tools including the FRAIL Screen, the Charlson Comorbidity Index, the SF-36, the Trail Making Test (TMT), the Rapid Cognitive Screen, the Self Mini Nutritional Assessment (MNA-SF) and the Lawton iADL as well as standard physical exercises were assessed using observational protocols. The FRAIL Screen, MNA-SF, Rapid Cognitive Screen, Lawton iADL and the physical exercises were deemed to be feasible with only minor comprehension, execution and safety issues. The TMT was not considered to be feasible and the SF-36 should be replaced by its shorter form, the SF-12. In order to ensure the validity of these findings a study with a larger sample size should be undertaken.

78 FR 60291 - Investigational Device Exemptions for Early Feasibility Medical Device Clinical Studies...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-10-01

...] Investigational Device Exemptions for Early Feasibility Medical Device Clinical Studies, Including Certain First in Human Studies; Guidance for Industry and Food and Drug Administration Staff; Availability AGENCY... Feasibility Medical Device Clinical Studies, Including Certain First in Human (FIH) Studies.'' Through the...

Feasibility and cardiac safety of inhaled xenon in combination with therapeutic hypothermia following out-of-hospital cardiac arrest.

PubMed

Arola, Olli J; Laitio, Ruut M; Roine, Risto O; Grönlund, Juha; Saraste, Antti; Pietilä, Mikko; Airaksinen, Juhani; Perttilä, Juha; Scheinin, Harry; Olkkola, Klaus T; Maze, Mervyn; Laitio, Timo T

2013-09-01

Preclinical studies reveal the neuroprotective properties of xenon, especially when combined with hypothermia. The purpose of this study was to investigate the feasibility and cardiac safety of inhaled xenon treatment combined with therapeutic hypothermia in out-of-hospital cardiac arrest patients. An open controlled and randomized single-centre clinical drug trial (clinicaltrials.gov NCT00879892). A multipurpose ICU in university hospital. Thirty-six adult out-of-hospital cardiac arrest patients (18-80 years old) with ventricular fibrillation or pulseless ventricular tachycardia as initial cardiac rhythm. Patients were randomly assigned to receive either mild therapeutic hypothermia treatment with target temperature of 33°C (mild therapeutic hypothermia group, n=18) alone or in combination with xenon by inhalation, to achieve a target concentration of at least 40% (Xenon+mild therapeutic hypothermia group, n=18) for 24 hours. Thirty-three patients were evaluable (mild therapeutic hypothermia group, n=17; Xenon+mild therapeutic hypothermia group, n=16). Patients were treated and monitored according to the Utstein protocol. The release of troponin-T was determined at arrival to hospital and at 24, 48, and 72 hours after out-of-hospital cardiac arrest. The median end-tidal xenon concentration was 47% and duration of the xenon inhalation was 25.5 hours. The frequency of serious adverse events, including inhospital mortality, status epilepticus, and acute kidney injury, was similar in both groups and there were no unexpected serious adverse reactions to xenon during hospital stay. In addition, xenon did not induce significant conduction, repolarization, or rhythm abnormalities. Median dose of norepinephrine during hypothermia was lower in xenon-treated patients (mild therapeutic hypothermia group=5.30 mg vs Xenon+mild therapeutic hypothermia group=2.95 mg, p=0.06). Heart rate was significantly lower in Xenon+mild therapeutic hypothermia patients during hypothermia

Endoscopic colostomy with percutaneous colopexy: an animal feasibility study.

PubMed

Bustamante-Lopez, Leonardo Alfonso; Sulbaran, Marianny; Nahas, Sergio Carlos; de Moura, Eduardo Guimaraes Horneaux; Nahas, Caio Sergio; Marques, Carlos Frederico; Sakai, Christiano; Cecconello, Ivan; Sakai, Paulo

2017-04-01

Indications for colostomy in colorectal diseases are obstruction of the large bowel, such as in cancer, diverticular disease in the acute phase, post-radiotherapy enteritis, complex perirectal fistulas, anorectal trauma and severe anal incontinence. Some critically ill patients cannot tolerate an exploratory laparotomy, and laparoscopic assisted colostomy also requires general anesthesia. To evaluate the feasibility, safety and efficacy of performing colostomy assisted by colonoscopy and percutaneous colopexy. Five pigs underwent endoscopic assisted colostomy with percutaneous colopexy. Animals were evaluated in post-operative days 1, 2, 5 and 7 for feeding acceptance and colostomy characteristics. On day 7 full colonoscopy was performed on animals followed by exploratory laparotomy. Average procedure time was 27 minutes (21-54 min). Postoperative mobility and feeding of animals were immediate after anesthesia recovery. Position of the colostomy, edges color, appearance of periostomal area, as well as its function was satisfactory in four animals. Retraction of colostomy was present in one pig. The colonoscopy and laparotomy control on the seventh day were considered as normal. A bladder perforation that was successfully repaired through the colostomy incision occurred in one pig. The main limitation of this study is its experimental nature. Endoscopic assisted colostomy with percutaneous colopexy proves to be a safe and effective method with low morbidity for performing colostomy in experimental animals, with possible clinical application in humans.

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

Manned space flight nuclear system safety. Volume 1: base nuclear system safety

NASA Technical Reports Server (NTRS)

1972-01-01

The mission and terrestrial nuclear safety aspects of future long duration manned space missions in low earth orbit are discussed. Nuclear hazards of a typical low earth orbit Space Base mission (from natural sources and on-board nuclear hardware) have been identified and evaluated. Some of the principal nuclear safety design and procedural considerations involved in launch, orbital, and end of mission operations are presented. Areas of investigation include radiation interactions with the crew, subsystems, facilities, experiments, film, interfacing vehicles, nuclear hardware and the terrestrial populace. Results of the analysis indicate: (1) the natural space environment can be the dominant radiation source in a low earth orbit where reactors are effectively shielded, (2) with implementation of safety guidelines the reactor can present a low risk to the crew, support personnel, the terrestrial populace, flight hardware and the mission, (3) ten year missions are feasible without exceeding integrated radiation limits assigned to flight hardware, and (4) crew stay-times up to one year are feasible without storm shelter provisions.

IPNS upgrade: A feasibility study

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

NONE

1995-04-01

Many of Argonne National Laboratory`s (ANL`s) scientific staff members were very active in R&D work related to accelerator-based spoliation sources in the 1970s and early 1980s. In 1984, the Seitz/Eastman Panel of the National Academy of Sciences reviewed U.S. materials science research facilities. One of the recommendations of this panel was that the United States build a reactor-based steady-state source, the Advanced Neutron Source (ANS), at Oak Ridge National Laboratory. Subsequently, R&D activities related to the design of an accelerator-based source assumed a lower priority. The resumption of pulsed-source studies in this country started simultaneously with design activities in Europemore » aimed at the European Spallation Source (ESS). The European Community funded a workshop in September 1991 to define the parameters of the ESS. Participants in this workshop included both accelerator builders and neutron source users. A consortium of European countries has proposed to build a 5-MW pulsed source, and a feasibility study is currently under way. Soon after the birth of the ESS, a small group at ANL set about bringing themselves up to date on pulsed-source information since 1984 and studied the feasibility of upgrading ANL`s Intense Pulsed Neutron Source (IPNS) to 1 MW by means of a rapidly cycling synchrotron that could be housed, along with its support facilities, in existing buildings. In early 1993, the Kohn panel recommended that (1) design and construction of the ANS should be completed according to the proposed project schedule and (2) development of competitive proposals for cost-effective design and construction of a 1-MW pulsed spallation source should be authorized immediately.« less

NASA CPAS Drogue Textile Riser Feasibility Study

NASA Technical Reports Server (NTRS)

Hennings, Elsa J.; Petersen, Michael L.; Anderson, Brian; Johnson, Brian

2015-01-01

Steel cable was chosen for the lower end of the drogue and main parachute risers on NASA's Orion Multi Purpose Crew Vehicle Parachute Assembly System (CPAS) to protect the risers from extreme temperatures and abrasion should they contact the crew module during deployment, as was done for Apollo. Due to the weight and deployment complexity inherent in steel, there was significant interest in the possibility of substituting textile for steel for the drogue and main parachute risers. However, textile risers could be damaged when subjected to high temperature and abrasion. Investigations were consequently performed by a subset of the authors to determine whether sacrificial, non-load-bearing textile riser covers could be developed to mitigate the thermal and abrasion concerns. Multiple material combinations were tested, resulting in a cover design capable of protecting the riser against severe riser/crew module contact interactions. A feasibility study was then conducted to evaluate the performance of the textile drogue riser cover in relevant abrasive environments. This paper describes the testing performed and documents the results of this feasibility study.

Important considerations for feasibility studies in physical activity research involving persons with multiple sclerosis: a scoping systematic review and case study.

PubMed

Learmonth, Yvonne C; Motl, Robert W

2018-01-01

Much research has been undertaken to establish the important benefits of physical activity in persons with multiple sclerosis (MS). There is disagreement regarding the strength of this research, perhaps because the majority of studies on physical activity and its benefits have not undergone initial and systematic feasibility testing. We aim to address the feasibility processes that have been examined within the context of physical activity interventions in MS. A systematic scoping review was conducted based on a literature search of five databases to identify feasibility processes described in preliminary studies of physical activity in MS. We read and extracted methodology from each study based on the following feasibility metrics: process (e.g. recruitment), resource (e.g. monetary costs), management (e.g. personnel time requirements) and scientific outcomes (e.g. clinical/participant reported outcome measures). We illustrate the use of the four feasibility metrics within a randomised controlled trial of a home-based exercise intervention in persons with MS. Twenty-five studies were identified. Resource feasibility (e.g. time and resources) and scientific outcomes feasibility (e.g. clinical outcomes) methodologies were applied and described in many studies; however, these metrics have not been systematically addressed. Metrics related to process feasibility (e.g. recruitment) and management feasibility (e.g. human and data management) are not well described within the literature. Our case study successfully enabled us to address the four feasibility metrics, and we provide new information on management feasibility (i.e. estimate data completeness and estimate data entry) and scientific outcomes feasibility (i.e. determining data collection materials appropriateness). Our review highlights the existing research and provides a case study which assesses important metrics of study feasibility. This review serves as a clarion call for feasibility trials that will

A safety study of transumbilical single incision versus conventional laparoscopic surgery for colorectal cancer: study protocol for a randomized controlled trial.

PubMed

Wang, Yanan; Liu, Ruoyan; Zhang, Ze; Xue, Qi; Yan, Jun; Yu, Jiang; Liu, Hao; Zhao, Liying; Mou, Tingyu; Deng, Haijun; Li, Guoxin

2015-11-30

Single-incision laparoscopic surgery (SILS) is an emerging minimally invasive surgery to reduce abdominal incisions. However, despite the increasing clinical application of SILS, no evidence from large-scale, randomized controlled trials is available for assessing the feasibility, short-term safety, oncological safety, and potential benefits of SILS compared with conventional laparoscopic surgery (CLS) for colorectal cancer. This is a single-center, open-label, noninferiority, randomized controlled trial. A total of 198 eligible patients will be randomly assigned to transumbilical single incision plus one port laparoscopic surgery (SILS plus one) group or to a CLS group at a 1:1 ratio. Patients ranging in age from 18 to 80 years with rectosigmoid cancer diagnosed as cT1-4aN0-2 M0 and a tumor size no larger than 5 cm are considered eligible. The primary endpoint is early morbidity, as evaluated by an independent investigator. Secondary outcomes include operative outcomes (operative time, estimated blood loss, and incision length), pathologic outcomes (tumor size, length of proximal and distal resection margins, and number of harvested lymph nodes), postoperative inflammatory and immune responses (white blood cells [WBC], neutrophil percentage [NE %], C-reactive protein [CRP], interleukin-6 [IL-6], and tumor necrosis factor-α [TNF-α]), postoperative recovery (time to first ambulation, flatus, liquid diet, soft diet, and duration of hospital stay), pain intensity, body image and cosmetic assessment, 3-year disease free survival (DFS), and 5-year overall survival (OS). Follow-up visits are scheduled for 1 and 3 months after surgery, then every 3 months for the first 2 years and every 6 months for the next 3 years. This trial will provide valuable clinical evidence for the objective assessment of the feasibility, safety, and potential benefits of SILS plus one compared with CLS for the radical resection of rectosigmoid cancer. The hypothesis is that SILS plus one is

Teleretinal Screening for Diabetic Retinopathy in Six Los Angeles Urban Safety-Net Clinics: Final Study Results

PubMed Central

Ogunyemi, Omolola; George, Sheba; Patty, Lauren; Teklehaimanot, Senait; Baker, Richard

2013-01-01

In a previous paper, we presented initial findings from a study on the feasibility and challenges of implementing teleretinal screening for diabetic retinopathy in an urban safety net setting facing eyecare specialist shortages. This paper presents some final results from that study, which involved six South Los Angeles safety net clinics. A total of 2,732 unique patients were screened for diabetic retinopathy by three ophthalmologist readers, with 1035 receiving a recommendation for referral to specialty care. Referrals included 48 for proliferative diabetic retinopathy, 115 for severe non-proliferative diabetic retinopathy (NPDR), 247 for moderate NPDR, 246 for mild NPDR, 97 for clinically significant macular edema, and 282 for a non-diabetic condition, such as glaucoma. Image quality was also assessed, with ophthalmologist readers grading 4% to 13% of retinal images taken at the different clinics as being inadequate for any diagnostic interpretation. PMID:24551394

Enhanced Flight Vision Systems Operational Feasibility Study Using Radar and Infrared Sensors

NASA Technical Reports Server (NTRS)

Etherington, Timothy J.; Kramer, Lynda J.; Severance, Kurt; Bailey, Randall E.; Williams, Steven P.; Harrison, Stephanie J.

2015-01-01

Approach and landing operations during periods of reduced visibility have plagued aircraft pilots since the beginning of aviation. Although techniques are currently available to mitigate some of the visibility conditions, these operations are still ultimately limited by the pilot's ability to "see" required visual landing references (e.g., markings and/or lights of threshold and touchdown zone) and require significant and costly ground infrastructure. Certified Enhanced Flight Vision Systems (EFVS) have shown promise to lift the obscuration veil. They allow the pilot to operate with enhanced vision, in lieu of natural vision, in the visual segment to enable equivalent visual operations (EVO). An aviation standards document was developed with industry and government consensus for using an EFVS for approach, landing, and rollout to a safe taxi speed in visibilities as low as 300 feet runway visual range (RVR). These new standards establish performance, integrity, availability, and safety requirements to operate in this regime without reliance on a pilot's or flight crew's natural vision by use of a fail-operational EFVS. A pilot-in-the-loop high-fidelity motion simulation study was conducted at NASA Langley Research Center to evaluate the operational feasibility, pilot workload, and pilot acceptability of conducting straight-in instrument approaches with published vertical guidance to landing, touchdown, and rollout to a safe taxi speed in visibility as low as 300 feet RVR by use of vision system technologies on a head-up display (HUD) without need or reliance on natural vision. Twelve crews flew various landing and departure scenarios in 1800, 1000, 700, and 300 RVR. This paper details the non-normal results of the study including objective and subjective measures of performance and acceptability. The study validated the operational feasibility of approach and departure operations and success was independent of visibility conditions. Failures were handled within the

Bond Feasibility Study. Project Identification Committee Report.

ERIC Educational Resources Information Center

Wichita Public Schools, KS.

A committee, appointed by the Board of Education, was requested to make a comprehensive study of the school building needs of Unified School District No. 259. In an attempt to determine the feasibility of a general bond election to upgrade the public schools, the specific charge to the committee was to evaluate the needs for physical plant…

THE COMMUNITY-APPRENTICESHIP PROGRAM, A FEASIBILITY STUDY.

ERIC Educational Resources Information Center

ISAACK, THOMAS S.

A STUDY WAS CONDUCTED TO EXAMINE THE FEASIBILITY OF ESTABLISHING COMMUNITY APPRENTICESHIP PROGRAMS IN WEST VIRGINIA. THE CONCEPT IS THAT A WORKER IN ONE COMPANY WOULD UNDERTAKE ON THE JOB TRAINING AT ANOTHER COMPANY TO TAKE ADVANTAGE OF MACHINES AND EQUIPMENT NOT CURRENTLY OWNED BY HIS COMPANY. THE AUTHOR STATES THAT THIS WOULD UPGRADE THE WORK…

Investigation of structural factors of safety for the space shuttle

NASA Technical Reports Server (NTRS)

1972-01-01

A study was made of the factors governing the structural design of the fully reusable space shuttle booster to establish a rational approach to select optimum structural factors of safety. The study included trade studies of structural factors of safety versus booster service life, weight, cost, and reliability. Similar trade studies can be made on other vehicles using the procedures developed. The major structural components of a selected baseline booster were studied in depth, each being examined to determine the fatigue life, safe-life, and fail-safe capabilities of the baseline design. Each component was further examined to determine its reliability and safety requirements, and the change of structural weight with factors of safety. The apparent factors of safety resulting from fatigue, safe-life, proof test, and fail-safe requirements were identified. The feasibility of reduced factors of safety for design loads such as engine thrust, which are well defined, was examined.

Current status of pharmacokinetic and safety studies of multidrug-resistant tuberculosis treatment in children.

PubMed

Garcia-Prats, A J; Svensson, E M; Weld, E D; Schaaf, H S; Hesseling, A C

2018-05-01

After decades of neglect, data are finally becoming available on the appropriate, safe dosing of key second-line anti-tuberculosis drugs used for treating multidrug-resistant tuberculosis (MDR-TB) in children, including levofloxacin (LVX), moxifloxacin (MFX), linezolid (LZD) and delamanid (DLM). Much needed data on some novel and repurposed drugs are still lacking, including for bedaquiline (BDQ), pretomanid (PTM) and clofazimine (CFZ). We review the status of pharmacokinetic (PK) and safety studies of key anti-tuberculosis medications in children with MDR-TB, identify priority knowledge gaps and note ongoing work to address those gaps, in the context of planning for an efficacy trial in children with MDR-TB. There is international consensus that an efficacy trial of a novel, all-oral, shortened MDR-TB treatment trial in children is both needed and feasible. Key novel and repurposed second-line anti-tuberculosis drugs include BDQ, DLM, PTM, MFX, LVX, CFZ and LZD. The rapidly emerging PK and safety data on these medications in children with MDR-TB from studies that are underway, completed or planned, will be critical in supporting such an efficacy trial. Commitment to addressing the remaining knowledge gaps, developing child-friendly formulations of key medications, improving the design of paediatric PK and safety studies, and development of international trial capacity in children with MDR-TB are important priorities.

Feasibility and Safety of Evaluating Patients with Prior Coronary Artery Disease Using an Accelerated Diagnostic Algorithm in a Chest Pain Unit

PubMed Central

Goldkorn, Ronen; Goitein, Orly; Ben-Zekery, Sagit; Shlomo, Nir; Narodetsky, Michael; Livne, Moran; Sabbag, Avi; Asher, Elad; Matetzky, Shlomi

2016-01-01

An accelerated diagnostic protocol for evaluating low-risk patients with acute chest pain in a cardiologist-based chest pain unit (CPU) is widely employed today. However, limited data exist regarding the feasibility of such an algorithm for patients with a history of prior coronary artery disease (CAD). The aim of the current study was to assess the feasibility and safety of evaluating patients with a history of prior CAD using an accelerated diagnostic protocol. We evaluated 1,220 consecutive patients presenting with acute chest pain and hospitalized in our CPU. Patients were stratified according to whether they had a history of prior CAD or not. The primary composite outcome was defined as a composite of readmission due to chest pain, acute coronary syndrome, coronary revascularization, or death during a 60-day follow-up period. Overall, 268 (22%) patients had a history of prior CAD. Non-invasive evaluation was performed in 1,112 (91%) patients. While patients with a history of prior CAD had more comorbidities, the two study groups were similar regarding hospitalization rates (9% vs. 13%, p = 0.08), coronary angiography (13% vs. 11%, p = 0.41), and revascularization (6.5% vs. 5.7%, p = 0.8) performed during CPU evaluation. At 60-days the primary endpoint was observed in 12 (1.6%) and 6 (3.2%) patients without and with a history of prior CAD, respectively (p = 0.836). No mortalities were recorded. To conclude, Patients with a history of prior CAD can be expeditiously and safely evaluated using an accelerated diagnostic protocol in a CPU with outcomes not differing from patients without such a history. PMID:27669521

Feasibility study of liquid pool burning in reduced gravity

NASA Technical Reports Server (NTRS)

Kanury, A. M.

1979-01-01

The feasibility of conducting experiments in the Spacelab on ignition and flame spread with liquid fuel pools which are initially at a temperature lower than the fuel's flash point temperature was studied. Theories were developed for the ignition and flame spread processes, and experiments were conducted to understand the factors influencing the ignition process and the spread rate. The results were employed to devise a conceptual Spacelab experiment which is expected to be feasible for a safe conduct and to be suitable for obtaining crucial data on the concerned processes.

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

Improving the governance of patient safety in emergency care: a systematic review of interventions

PubMed Central

Hesselink, Gijs; Berben, Sivera; Beune, Thimpe

2016-01-01

Objectives To systematically review interventions that aim to improve the governance of patient safety within emergency care on effectiveness, reliability, validity and feasibility. Design A systematic review of the literature. Methods PubMed, EMBASE, Cumulative Index to Nursing and Allied Health Literature, the Cochrane Database of Systematic Reviews and PsychInfo were searched for studies published between January 1990 and July 2014. We included studies evaluating interventions relevant for higher management to oversee and manage patient safety, in prehospital emergency medical service (EMS) organisations and hospital-based emergency departments (EDs). Two reviewers independently selected candidate studies, extracted data and assessed study quality. Studies were categorised according to study quality, setting, sample, intervention characteristics and findings. Results Of the 18 included studies, 13 (72%) were non-experimental. Nine studies (50%) reported data on the reliability and/or validity of the intervention. Eight studies (44%) reported on the feasibility of the intervention. Only 4 studies (22%) reported statistically significant effects. The use of a simulation-based training programme and well-designed incident reporting systems led to a statistically significant improvement of safety knowledge and attitudes by ED staff and an increase of incident reports within EDs, respectively. Conclusions Characteristics of the interventions included in this review (eg, anonymous incident reporting and validation of incident reports by an independent party) could provide useful input for the design of an effective tool to govern patient safety in EMS organisations and EDs. However, executives cannot rely on a robust set of evidence-based and feasible tools to govern patient safety within their emergency care organisation and in the chain of emergency care. Established strategies from other high-risk sectors need to be evaluated in emergency care settings, using an

Longitudinal study of the feasibility of using ecological momentary assessment to study teacher stress: Objective and self-reported measures.

PubMed

McIntyre, Teresa M; McIntyre, Scott E; Barr, Christopher D; Woodward, Phillip S; Francis, David J; Durand, Angelia C; Mehta, Paras; Kamarck, Thomas W

2016-10-01

There is a lack of comprehensive research on Ecological Momentary Assessment (EMA) feasibility to study occupational stress, especially its long-term sustainability. EMA application in education contexts has also been sparse. This study investigated the feasibility of using EMA to study teacher stress over 2 years using both objective compliance data and a self-reported feasibility survey. It also examined the influence of individual and school factors on EMA feasibility. Participants were 202 sixth through eighth grade teachers from 22 urban middle schools in the southern United States. EMA was implemented via an iPod-based Teacher Stress Diary (TSD). Teachers recorded demands, stress responses, and resources during 12 days (6 waves) over 2 years. Feasibility was assessed via compliance data generated by the TSD (e.g., entry completion) and an EMA Feasibility Survey of self-reported user-friendliness and EMA interference. The results showed high compliance regarding entry and item completion, and completion time, which was sustained over time. User-friendliness was appraised as very high and EMA interference as low. Initial difficulties regarding timing and length of assessments were addressed via EMA method refinement, resulting in improved feasibility. Teachers' ethnicity, age, marital status, grade/course taught, class size, class load, and daily workload impacted feasibility. The results supported the feasibility of using EMA to study work stress longitudinally and the value of continued feasibility monitoring. They also support EMA use to study teacher stress and inform EMA implementation in schools. Some teacher and school factors need to be taken into consideration when deciding on EMA implementation in education contexts. (PsycINFO Database Record (c) 2016 APA, all rights reserved).

Feasibility study ASCS remote sensing/compliance determination system

NASA Technical Reports Server (NTRS)

Duggan, I. E.; Minter, T. C., Jr.; Moore, B. H.; Nosworthy, C. T.

1973-01-01

A short-term technical study was performed by the MSC Earth Observations Division to determine the feasibility of the proposed Agricultural Stabilization and Conservation Service Automatic Remote Sensing/Compliance Determination System. For the study, the term automatic was interpreted as applying to an automated remote-sensing system that includes data acquisition, processing, and management.

Feasibility study on intersection in North Sumatera

NASA Astrophysics Data System (ADS)

Hastuty, I. P.; Sembiring, I. S.; Anas, R.; Lubis, A. S.

2018-02-01

Traffic congestion is one of the problems faced by big cities, One of them is Binjai city and Medan city in North Sumatera. One of the causes of congestion is intersection of roads with highway and roads with railroads. To ensure the smooth movement of vehicles, technical handling at the intersection is needed. Therefore, it is necessary to pre-study the feasibility of level crossing in Binjai and Medan to be able to assess the investment needs and the level of importance of road development in the region. The development of transportation infrastructure and facilities is based on the thought of improving the transportation network system. The necessity of systemical integrated transportation system handling is needed in creating a transportation efficiency. The purpose of this study is to identify and prioritize the needs of the railway crossings. The objective which we want to be achieved is to obtain a document that contains technical, economic and environmental ability indicators as a reference in the feasibility and planning studies. The methodology used is collecting the primary data, secondary data, introduction of study area as the initial analysis of the problem. From the study it can be concluded that the existence of railway interchange will move the movement through traffic so it will not interfere the movement of traffic within urban areas and it keeps the national road network performance is still good.

US-Canada Great Lakes Regional Specimen Bank Feasibility Study.

PubMed

Kerry, A; Edmonds, C J; Landon, L; Yonker, T L

1993-11-01

A study to examine the feasibility of establishing a Regional Specimen Bank in the Great Lakes area of the United States and Canada has recently been initiated by the Michigan Audubon Society. There are several existing formal and informal specimen banking facilities active in the region but their combined adequacy has not been evaluated. This feasibility study will establish the need and use of a regional bank and the institution(s) necessary to satisfy this need will be recommended. The study will address the scope required to meet present and future needs including the types of specimens to be represented in the bank, geographic coverage and protocols for collection, shipping, processing, analysis and storage. A management policy of the bank will be developed encompassing business operation, costs, governing structure and personnel requirements. The legal requirements of the bank will be determined with regards to the acquisition of samples, transport across national boundaries, access to specimens and information, and liability during operation. An effective information dissemination network will be recommended that is compatible with national and international partners, will facilitate technology and information transfer and support the quality and status of the bank. Determination of secure, long-term funding sources will be one of the key elements to ensuring a safe repository. This feasibility study is funded by the Great Lakes Protection Fund.

Implementation of enhanced recovery programme for laparoscopic distal pancreatectomy: feasibility, safety and cost analysis.

PubMed

Richardson, John; Di Fabio, Francesco; Clarke, Hannah; Bajalan, Mohammed; Davids, Joe; Abu Hilal, Mohammed

2015-01-01

The adoption of laparoscopy for distal pancreatectomy has proven to substantially improve short-term outcomes. Stress response after major surgery can be further minimized within an enhanced recovery programme (ERP). However, data on the potential benefit of an ERP for laparoscopic distal pancreatectomy are still lacking. The aim was to assess the feasibility, safety and cost of ERP for patients undergoing laparoscopic distal pancreatectomy. This is a case-control study from a Tertiary University Hospital. Sixty-six consecutive patients who underwent laparoscopic distal pancreatectomy were analyzed. Twenty-two patients were enrolled for the ERP and compared with previous consecutive 44 patients managed traditionally (1:2 ratio). Operative details, post-operative outcome and cost analysis were compared in the two groups. Patients enrolled in the ERP had similar intraoperative blood loss (median 165 ml vs. 200 ml; p = 0.176), operation time (225 min vs. 210 min; p = 0.633), time to remove naso-gastric tube (1 vs. 1 day; p = 0.081) but significantly shorter time to mobilization (median 1 vs. 2 days; p = 0.0001), start solid diet (2 vs. 3 days; p = 0004), and pass stools (3 vs. 5 days; p = 0.002) compared to the control group. Median length of stay was significantly shorter in the ERP group (3 vs. 6 days; p < 0.0001). No significant difference in readmission or complication rate was observed. Cost analysis was significantly in favor of the ERP group (p = 0.0004). Implementation of ERP optimizes outcomes for laparoscopic distal pancreatectomy with significant earlier return to normal gut function, reduced length of stay and cost saving. Copyright © 2015 IAP and EPC. Published by Elsevier B.V. All rights reserved.

Active Treatment for Idiopathic Adolescent Scoliosis (ACTIvATeS): a feasibility study.

PubMed

Williams, Mark A; Heine, Peter J; Williamson, Esther M; Toye, Francine; Dritsaki, Melina; Petrou, Stavros; Crossman, Richard; Lall, Ranjit; Barker, Karen L; Fairbank, Jeremy; Harding, Ian; Gardner, Adrian; Slowther, Anne-Marie; Coulson, Neil; Lamb, Sarah E

2015-07-01

The feasibility of conducting a definitive randomised controlled trial (RCT) evaluating the clinical effectiveness and cost-effectiveness of scoliosis-specific exercises (SSEs) for adolescent idiopathic scoliosis (AIS) is uncertain. The aim of this study was to assess the feasibility of conducting a large, multicentre trial of SSE treatment for patients with AIS, in comparison with standard care, and to refine elements of the study design. The objectives were to (1) update a systematic review of controlled trials evaluating the efficacy of SSE in AIS; (2) survey UK orthopaedic surgeons and physiotherapists to determine current practice, patient populations and equipoise; (3) randomise 50 adolescents to a feasibility trial of either usual care or SSE interventions across a range of sites; (4) develop, document and assess acceptability and adherence of interventions; (5) assess and describe training requirements of physiotherapists; and (6) gain user input in all relevant stages of treatment and protocol design. Multicomponent feasibility study including UK clinician survey, systematic literature review and a randomised feasibility trial. The randomised feasibility study involved four secondary care NHS trusts providing specialist care for patients with AIS. The randomised feasibility study recruited people aged 10-16 years with mild AIS (Cobb angle of < 50°). The randomised study allocated participants to standard practice of advice and education or a physiotherapy SSE programme supported by a home exercise plan. Our choice of intervention was informed by a systematic review of exercise interventions for AIS. The main outcome was feasibility of recruitment to the randomised study. Other elements were to inform choice of outcomes for a definitive trial and included curve severity, quality of life, requirement for surgery/brace, adverse events, psychological symptoms, costs and health utilities. A UK survey of orthopaedic consultants and physiotherapists indicated

Training Endogenous Task Shifting Using Music Therapy: A Feasibility Study.

PubMed

Lynch, Colleen; LaGasse, A Blythe

2016-01-01

People with acquired brain injury (ABI) are highly susceptible to disturbances in executive functioning (EF), and these effects are pervasive. Research studies using music therapy for cognitive improvement in this population are limited. The purpose of this study was to determine the feasibility of a Musical Executive Function Training (MEFT) intervention to address task-shifting skills in adults with ABI and to obtain preliminary evidence of intervention effect on task shifting. Fourteen participants were randomly assigned to one of three groups: a music therapy intervention group (MTG), a singing group (SG), or the no-intervention control group (CG). The SG and MTG met for one hour a day for five days. Feasibility measures included participant completion rates and intervention fidelity. Potential benefits were measured using the Trail Making Test and the Paced Auditory Serial Addition Task as a pre- and posttest measure. Participant completion rates and interventionist fidelity to the protocol supported feasibility. One-way ANOVA of the pre- and posttest group differences revealed a trend toward improvement in the MTG over the SG. Feasibility and effect size data support a larger trial of the MEFT protocol. © the American Music Therapy Association 2016. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

Randomized controlled trial of Family Nurture Intervention in the NICU: assessments of length of stay, feasibility and safety.

PubMed

Welch, Martha G; Hofer, Myron A; Stark, Raymond I; Andrews, Howard F; Austin, Judy; Glickstein, Sara B; Ludwig, Robert J; Myers, Michael M

2013-09-24

While survival rates for preterm infants have increased, the risk for adverse long-term neurodevelopmental and behavioral outcomes remains very high. In response to the need for novel, evidence-based interventions that prevent such outcomes, we have assessed Family Nurture Intervention (FNI), a novel dual mother-infant intervention implemented while the infant is in the Neonatal Intensive Care Unit (NICU). Here, we report the first trial results, including the primary outcome measure, length of stay in the NICU and, the feasibility and safety of its implementation in a high acuity level IV NICU. The FNI trial is a single center, parallel-group, randomized controlled trial at Morgan Stanley Children's Hospital for mothers and their singleton or twin infants of 26-34 weeks gestation. Families were randomized to standard care (SC) or (FNI). FNI was implemented by nurture specialists trained to facilitate affective communication between mother and infant during specified calming interactions. These interactions included scent cloth exchange, sustained touch, vocal soothing and eye contact, wrapped or skin-to-skin holding, plus family-based support interactions. A total of 826 infants born between 26 and 34 weeks during the 3.5 year study period were admitted to the NICU. After infant and mother screening plus exclusion due to circumstances that prevented the family from participating, 373 infants were eligible for the study. Of these, we were unable to schedule a consent meeting with 56, and consent was withheld by 165. Consent was obtained for 150 infants from 115 families. The infants were block randomized to groups of N = 78, FNI and N = 72, SC. Sixteen (9.6%) of the randomized infants did not complete the study to home discharge, 7% of those randomized to SC and 12% of FNI infants. Mothers in the intervention group engaged in 3 to 4 facilitated one- to two-hour sessions/week. Intent to treat analyses revealed no significant difference between groups in

Language barriers and patient safety risks in hospital care. A mixed methods study.

PubMed

van Rosse, Floor; de Bruijne, Martine; Suurmond, Jeanine; Essink-Bot, Marie-Louise; Wagner, Cordula

2016-02-01

A language barrier has been shown to be a threat for quality of hospital care. International studies highlighted a lack of adequate noticing, reporting, and bridging of a language barrier. However, studies on the link between language proficiency and patient safety are scarce, especially in Europe. The present study investigates patient safety risks due to language barriers during hospitalization, and the way language barriers are detected, reported, and bridged in Dutch hospital care. We combined quantitative and qualitative methods in a sample of 576 ethnic minority patients who were hospitalized on 30 wards within four urban hospitals. The nursing and medical records of 17 hospital admissions of patients with language barriers were qualitatively analyzed, and complemented by 12 in-depth interviews with care providers and patients and/or their relatives to identify patient safety risks during hospitalization. The medical records of all 576 patients were screened for language barrier reports. The results were compared to patients' self-reported Dutch language proficiency. The policies of wards regarding bridging language barriers were compared with the reported use of interpreters in the medical records. Situations in hospital care where a language barrier threatened patient safety included daily nursing tasks (i.e. medication administration, pain management, fluid balance management) and patient-physician interaction concerning diagnosis, risk communication and acute situations. In 30% of the patients that reported a low Dutch proficiency, no language barrier was documented in the patient record. Relatives of patients often functioned as interpreter for them and professional interpreters were hardly used. The present study showed a wide variety of risky situations in hospital care for patients with language barriers. These risks can be reduced by adequately bridging the language barrier, which, in the first place, demands adequate detecting and reporting of a

Visual Search in the Detection of Retinal Injury: A Feasibility Study

DTIC Science & Technology

2013-04-01

D, Heyes A. et al. Mobility of people with retinitis pigmentosa as a function of vision and psychological variables. Optometry and Vision Science...AFRL-RH-FS-TR-2013-0019 Visual Search in the Detection of Retinal Injury: A Feasibility Study Thomas Kuyk TASC, Inc. Lei Liu The...Detection of Retinal Injury: A Feasibility Study" 2013 0019 LEON N. McLIN, JR., DR-III, DAF Work Unit Manager 711 HPW/ RHDO POLHAMUS.GARR ETT.D

Flow Liner Slot Edge Replication Feasibility Study

NASA Technical Reports Server (NTRS)

Newman, John A.; Willard, Scott A.; Smith, Stephen W.; Piascik, Robert S.

2006-01-01

Surface replication has been proposed as a method for crack detection in space shuttle main engine flowliner slots. The results of a feasibility study show that examination of surface replicas with a scanning electron microscope can result in the detection of cracks as small as 0.005 inch, and surface flaws as small as 0.001 inch, for the flowliner material.

Intramyocardial injection of autologous bone marrow-derived ex vivo expanded mesenchymal stem cells in acute myocardial infarction patients is feasible and safe up to 5 years of follow-up.

PubMed

Rodrigo, Sander F; van Ramshorst, Jan; Hoogslag, Georgette E; Boden, Helèn; Velders, Matthijs A; Cannegieter, Suzanne C; Roelofs, Helene; Al Younis, Imad; Dibbets-Schneider, Petra; Fibbe, Willem E; Zwaginga, Jaap Jan; Bax, Jeroen J; Schalij, Martin J; Beeres, Saskia L; Atsma, Douwe E

2013-10-01

In experimental studies, mesenchymal stem cell (MSC) transplantation in acute myocardial infarction (AMI) models has been associated with enhanced neovascularization and myogenesis. Clinical data however, are scarce. Therefore, the present study evaluates the safety and feasibility of intramyocardial MSC injection in nine patients, shortly after AMI during short-term and 5-year follow-up. Periprocedural safety analysis demonstrated one transient ischemic attack. No other adverse events related to MSC treatment were observed during 5-year follow-up. Clinical events were compared to a nonrandomized control group comprising 45 matched controls. A 5-year event-free survival after MSC-treatment was comparable to controls (89 vs. 91 %, P = 0.87). Echocardiographic imaging for evaluation of left ventricular function demonstrated improvements up to 5 years after MSC treatment. These findings were not significantly different when compared to controls. The present safety and feasibility study suggest that intramyocardial injection of MSC in patients shortly after AMI is feasible and safe up to 5-year follow-up.

Laparoscopic cholecystectomy in acute gallstone pancreatitis in index hospital admission: feasibility and safety

PubMed Central

Sangrasi, Ahmed Khan; Syed, BM; Memon, Amir Iqbal; Laghari, Abdul Aziz; Talpur, K. Altaf Hussain; Qureshi, Jawaid Naeem

2014-01-01

Background and Objective: Acute gallstone pancreatitis is quite common throughout the globe. Conventionally definitive cholecystectomy has been delayed in index hospital admission. Since the last decade timing of cholecystectomy is gradually shifting towards the earlier phase of disease and currently gallstone pancreatitis is being evaluated as a further indication for laparoscopic cholecystectomy. There is also great concern regarding compliance of patients for definitive surgery due to poverty, ignorance and illiteracy in developing countries. The aim of this study was to assess the feasibility and safety of laparoscopic cholecystectomy as a definitive treatment in patients with mild and resolving gall stone pancreatitis. Methods: This was a prospective study from July 2009 to June 2012. Patients were diagnosed by clinical examination, biochemical tests, ultrasonography and contrast enhanced CT. Patients with mild form of the disease (Ranson Score ≤3) and who showed clinical improvement were offered laparoscopic cholecystectomy in index hospital admission. Those who were unfit for surgery were referred for endoscopic sphincterotomy. Common bile duct stones were excluded preoperatively. Results: A total of 38 patients were admitted with acute gallstone pancreatitis in the study period. The mean age of patients was 46.3 years with male to female ratio of 11/27. 22 (57.8%) patients were selected for laparoscopic cholecystectomy and procedure was completed successfully. Ten (26.3%) patients were referred for ERCP and endoscopic sphincterotomy and 11 (28.9%) were managed by conservative treatment and went without any definitive treatment. Mean duration of time from onset of symptoms and laparoscopic cholecystectomy was 7 days (range 4-10). Mean duration of operative time was 45 minutes and hospital stay was 7 days. There was no operative mortality. No major intra-operative or post-operative complication was recorded. two patients (9%) had minor complications

Preoperative biliary drainage using a fully covered self-expandable metallic stent for pancreatic head cancer: A prospective feasibility study.

PubMed

Togawa, Osamu; Isayama, Hiroyuki; Kawakami, Hiroshi; Nakai, Yousuke; Mohri, Dai; Hamada, Tsuyoshi; Kogure, Hirofumi; Kawakubo, Kazumichi; Sakamoto, Naoya; Koike, Kazuhiko; Kita, Hiroto

2018-01-01

The role of endoscopic preoperative biliary drainage (PBD) for pancreatic head cancer is controversial because of the high incidence of stent occlusion before surgery. This study was performed to evaluate the feasibility and safety of PBD using a fully covered self-expandable metallic stent (FCSEMS). This multicenter prospective study involved 26 patients treated for pancreatic head cancer with distal bile duct obstruction from April 2011 to March 2013. An FCSEMS was endoscopically placed in 24 patients. Among these, 7 patients were diagnosed with unresectable cancer, and 17 underwent surgery at a median of 18 days after FCSEMS placement. The main outcome measure was preoperative and postoperative adverse events. Two adverse events (cholecystitis and insufficient resolution of jaundice) occurred between FCSEMS placement and surgery (12%). Postoperative adverse events occurred in eight patients (47%). The cumulative incidence of stent-related adverse events 4 and 8 weeks after FCSEMS placement among the 24 patients who underwent this procedure were 19%. PBD using an FCSEMS is feasible in patients with resectable pancreatic head cancer. Placement of an FCSEMS can be an alternative PBD technique when surgery without delay is impossible. A larger randomized controlled trial is warranted.

Technical feasibility, diagnostic yield, and safety of microforceps biopsies during EUS evaluation of pancreatic cystic lesions (with video).

PubMed

Mittal, Chetan; Obuch, Joshua C; Hammad, Hazem; Edmundowicz, Steven A; Wani, Sachin; Shah, Raj J; Brauer, Brian C; Attwell, Augustin R; Kaplan, Jeffrey B; Wagh, Mihir S

2018-05-01

Through-the-needle microforceps are a recent addition to the EUS armamentarium for evaluation of pancreatic cystic lesions (PCLs). The main aim of this study was to assess the technical feasibility, diagnostic yield, and safety of EUS-guided microforceps biopsy for PCLs. Our electronic endoscopy database was queried to identify patients who underwent EUS-guided FNA (EUS-FNA) of PCLs and microforceps biopsies during the same procedure. A biopsy was done on the wall of the cyst with the microforceps through the 19-gauge needle, and cyst fluid was collected for cytology and carcinoembryonic antigen (CEA) levels. Adverse events were recorded per published American Society for Gastrointestinal Endoscopy criteria. Twenty-seven patients underwent EUS-FNA and microforceps biopsy of PCLs from February 2016 to July 2017. Fourteen cysts were located in the pancreatic head and/or uncinate, and 13 were located in the body and/or tail region. Microforceps biopsies were technically successful in all cases and provided a pathology diagnosis in 24 of 27 cases (yield 88.9%). Microforceps biopsies diagnosed mucinous cyst in 9 patients (33.3%), serous cystadenoma in 4 (14.8%), neuroendocrine tumor in 1 (3.7%), and benign and/or inflammatory cyst in 10 (37.1%). In 7 patients (26%), microforceps biopsy results drastically changed the diagnosis, providing diagnoses otherwise not suggested by cytology or cyst fluid CEA levels. However, cytology provided a diagnosis of mucinous cyst in 4 cases (14.8%) not detected by microforceps biopsies. No adverse events were noted. Microforceps biopsies were associated with high technical success, and an excellent safety profile and may be a useful adjunctive tool, complementing existing EUS-FNA sampling protocols for PCLs. Copyright © 2018 American Society for Gastrointestinal Endoscopy. Published by Elsevier Inc. All rights reserved.

Intracardiac echo-guided radiofrequency catheter ablation of atrial fibrillation in patients with atrial septal defect or patent foramen ovale repair: a feasibility, safety, and efficacy study.

PubMed

Lakkireddy, Dhanunjaya; Rangisetty, Umamahesh; Prasad, Subramanya; Verma, Atul; Biria, Mazda; Berenbom, Loren; Pimentel, Rhea; Emert, Martin; Rosamond, Thomas; Fahmy, Tamer; Patel, Dimpi; Di Biase, Luigi; Schweikert, Robert; Burkhardt, David; Natale, Andrea

2008-11-01

Intracardiac Echo-Guided Radiofrequency Catheter. Patients with atrial septal defect (ASD) are at higher risk for atrial fibrillation (AF) even after repair. Transseptal access in these patients is perceived to be difficult. We describe the feasibility, safety, and efficacy of pulmonary vein antral isolation (PVAI) in these patients. We prospectively compared post-ASD/patent foramen ovale (PFO) repair patients (group I, n = 45) with age-gender-AF type matched controls (group II, n = 45). All the patients underwent PVAI through a double transseptal puncture with a roving circular mapping catheter technique guided by intracardiac echocardiography (ICE). The short-term (3 months) and long-term (12 month) failure rates were assessed. In group I, 23 (51%) had percutaneous closure devices and 22 (49%) had a surgical closure. There was no significant difference between group I and II in the baseline characteristics. Intracardiac echo-guided double transseptal access was obtained in 98% of patients in group I and in 100% of patients in group II. PVAI was performed in all patients, with right atrial flutter ablation in 7 patients in group I and in 4 patients in group II. Over a mean follow-up of 15 +/- 4 months, group I had higher short-term (18% vs 13%, P = 0.77) and long-term recurrence (24% vs 18%, P = 0.6) than group II. There was no significant difference in the perioperative complications between the two groups. Echocardiography at 3 months showed interatrial communication in 2 patients in group I and 1 patient in group II, which resolved at 12 months. Percutaneous AF ablation using double transseptal access is feasible, safe, and efficacious in patients with ASD and PFO repairs.

Organic Waste Diversion in Columbia, South Carolina, Feasibility Study

EPA Science Inventory

The study found that a variety of methods are technically and economically feasible for diverting food wastes and providing a positive return on investment for the source. Potential barriers and considerations for food waste diversion are identified in the study. Given the E...

Balance and mobility training at home using Wii Fit in children with cerebral palsy: a feasibility study

PubMed Central

Ada, Louise; Lee, Shin-Da

2018-01-01

Objectives To investigate whether balance and mobility training at home using Wii Fit is feasible and can provide clinical benefits. Design Single-group, pre–post intervention study. Setting Participants’ home. Participants 20 children with cerebral palsy (6–12 years). Intervention Participants undertook 8 weeks of home-based Wii Fit training in addition to usual care. Main measures Feasibility was determined by adherence, performance, acceptability and safety. Clinical outcomes were strength, balance, mobility and participation measured at baseline (preintervention) and 8 weeks (postintervention). Results The training was feasible with 99% of training completed; performance on all games improved; parents understood the training (4/5), it did not interfere in life (3.8/5), was challenging (3.9/5) and would recommend it (3.9/5); and there were no injurious falls. Strength increased in dorsiflexors (Mean Difference (MD) 2.2 N m, 95% CI 1.1 to 3.2, p<0.001), plantarflexors (MD 2.2 N m, 95% CI 1.3 to 3.1, p<0.001) and quadriceps (MD 7.8 N m, 95% CI 5.2 to 10.5, p<0.001). Preferred walking speed increased (MD 0.25 m/s, 95% CI 0.09 to 0.41, p<0.01), fast speed increased (MD 0.24 m/s, 95% CI 0.13 to 0.35, p<0.001) and distance over 6 min increased (MD 28 m, 95% CI 10 to 45, p<0.01). Independence in participation increased (MD 1.4 out of 40, 95% CI 0.0 to 2.8, p=0.04). Conclusions Balance and mobility training at home using Wii Fit was feasible and safe and has the potential to improve strength and mobility, suggesting that a randomised trial is warranted. Trial registration number ACTRN12616001362482. PMID:29764871

Impact of a pilot walking school bus intervention on children's pedestrian safety behaviors: a pilot study

USDA-ARS?s Scientific Manuscript database

Walking school buses (WSB) increased children's physical activity, but impact on pedestrian safety behaviors (PSB) is unknown. We tested the feasibility of a protocol evaluating changes to PSB during a WSB program. Outcomes were school-level street crossing PSB prior to (Time 1) and during weeks 4–5...

Inpatient Massage Therapy Versus Music Therapy Versus Usual Care: A Mixed-methods Feasibility Randomized Controlled Trial

PubMed Central

Cornelio-Flores, Oscar; Lemaster, Chelsey; Hernandez, Maria; Fong, Calvin; Resnick, Kirsten; Wardle, Jon; Hanser, Suzanne; Saper, Robert

2017-01-01

Background Little is known about the feasibility of providing massage or music therapy to medical inpatients at urban safety-net hospitals or the impact these treatments may have on patient experience. Objective To determine the feasibility of providing massage and music therapy to medical inpatients and to assess the impact of these interventions on patient experience. Design Single-center 3-arm feasibility randomized controlled trial. Setting Urban academic safety-net hospital. Patients Adult inpatients on the Family Medicine ward. Interventions Massage therapy consisted of a standardized protocol adapted from a previous perioperative study. Music therapy involved a preference assessment, personalized compact disc, music-facilitated coping, singing/playing music, and/or songwriting. Credentialed therapists provided the interventions. Measurements Patient experience was measured with the Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) within 7 days of discharge. We compared the proportion of patients in each study arm reporting “top box” scores for the following a priori HCAHPS domains: pain management, recommendation of hospital, and overall hospital rating. Responses to additional open-ended postdischarge questions were transcribed, coded independently, and analyzed for common themes. Results From July to December 2014, 90 medical inpatients were enrolled; postdischarge data were collected on 68 (76%) medical inpatients. Participants were 70% females, 43% non-Hispanic black, and 23% Hispanic. No differences between groups were observed on HCAHPS. The qualitative analysis found that massage and music therapy were associated with improved overall hospital experience, pain management, and connectedness to the massage or music therapist. Conclusions Providing music and massage therapy in an urban safety-net inpatient setting was feasible. There was no quantitative impact on HCAHPS. Qualitative findings suggest benefits related to an

Inpatient Massage Therapy Versus Music Therapy Versus Usual Care: A Mixed-methods Feasibility Randomized Controlled Trial.

PubMed

Roseen, Eric J; Cornelio-Flores, Oscar; Lemaster, Chelsey; Hernandez, Maria; Fong, Calvin; Resnick, Kirsten; Wardle, Jon; Hanser, Suzanne; Saper, Robert

2017-01-01

Little is known about the feasibility of providing massage or music therapy to medical inpatients at urban safety-net hospitals or the impact these treatments may have on patient experience. To determine the feasibility of providing massage and music therapy to medical inpatients and to assess the impact of these interventions on patient experience. Single-center 3-arm feasibility randomized controlled trial. Urban academic safety-net hospital. Adult inpatients on the Family Medicine ward. Massage therapy consisted of a standardized protocol adapted from a previous perioperative study. Music therapy involved a preference assessment, personalized compact disc, music-facilitated coping, singing/playing music, and/or songwriting. Credentialed therapists provided the interventions. Patient experience was measured with the Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) within 7 days of discharge. We compared the proportion of patients in each study arm reporting "top box" scores for the following a priori HCAHPS domains: pain management, recommendation of hospital, and overall hospital rating. Responses to additional open-ended postdischarge questions were transcribed, coded independently, and analyzed for common themes. From July to December 2014, 90 medical inpatients were enrolled; postdischarge data were collected on 68 (76%) medical inpatients. Participants were 70% females, 43% non-Hispanic black, and 23% Hispanic. No differences between groups were observed on HCAHPS. The qualitative analysis found that massage and music therapy were associated with improved overall hospital experience, pain management, and connectedness to the massage or music therapist. Providing music and massage therapy in an urban safety-net inpatient setting was feasible. There was no quantitative impact on HCAHPS. Qualitative findings suggest benefits related to an improved hospital experience, pain management, and connectedness to the massage or music therapist.

Feasibility of extracting data from electronic medical records for research: an international comparative study.

PubMed

van Velthoven, Michelle Helena; Mastellos, Nikolaos; Majeed, Azeem; O'Donoghue, John; Car, Josip

2016-07-13

Electronic medical records (EMR) offer a major potential for secondary use of data for research which can improve the safety, quality and efficiency of healthcare. They also enable the measurement of disease burden at the population level. However, the extent to which this is feasible in different countries is not well known. This study aimed to: 1) assess information governance procedures for extracting data from EMR in 16 countries; and 2) explore the extent of EMR adoption and the quality and consistency of EMR data in 7 countries, using management of diabetes type 2 patients as an exemplar. We included 16 countries from Australia, Asia, the Middle East, and Europe to the Americas. We undertook a multi-method approach including both an online literature review and structured interviews with 59 stakeholders, including 25 physicians, 23 academics, 7 EMR providers, and 4 information commissioners. Data were analysed and synthesised thematically considering the most relevant issues. We found that procedures for information governance, levels of adoption and data quality varied across the countries studied. The required time and ease of obtaining approval also varies widely. While some countries seem ready for secondary uses of data from EMR, in other countries several barriers were found, including limited experience with using EMR data for research, lack of standard policies and procedures, bureaucracy, confidentiality, data security concerns, technical issues and costs. This is the first international comparative study to shed light on the feasibility of extracting EMR data across a number of countries. The study will inform future discussions and development of policies that aim to accelerate the adoption of EMR systems in high and middle income countries and seize the rich potential for secondary use of data arising from the use of EMR solutions.

A feasibility study of a hypersonic real-gas facility

NASA Technical Reports Server (NTRS)

Gully, J. H.; Driga, M. D.; Weldon, W. F.

1987-01-01

A four month feasibility study of a hypersonic real-gas free flight test facility for NASA Langley Research Center (LARC) was performed. The feasibility of using a high-energy electromagnetic launcher (EML) to accelerate complex models (lifting and nonlifting) in the hypersonic, real-gas facility was examined. Issues addressed include: design and performance of the accelerator; design and performance of the power supply; design and operation of the sabot and payload during acceleration and separation; effects of high current, magnetic fields, temperature, and stress on the sabot and payload; and survivability of payload instrumentation during acceleration, flight, and soft catch.

[Telescience : Feasibility studies, definition and a fair answer to the scientific brain drain].

PubMed

Craemer, E M; Bassa, B; Jacobi, C; Becher, H; Meyding-Lamadé, U

2017-02-01

What is telescience? Is it feasible to transfer academic information with the help of telematics to educate and teach young scientists over large distances? The term telescience has so far not been defined but covers a variety of possibilities, which could be successfully implemented worldwide. This article gives examples and highlights the feasibility analysis of telescience. We have carried out feasibility analyses for neurological functional diagnostics, an epidemiological cross-sectional study as well as a laboratory study for detection of thrombocyte function during dengue fever with the help of telemedicine. The basis for all these projects was a telemedical transcontinental cooperation over a distance of 12,000 km. All performed studies demonstrated the feasibility. With the help of telematics the laboratory techniques, planning, conduction and interpretation of results as well as publication skills can be transferred. Telescience is feasible. Our studies showed that telescience is a very promising option to transfer knowledge, which will help to enable professional expertise to be transferred directly to the region/country without a brain drain. All too often young motivated scientists are enticed to move to well-known institutions, which involves the danger of a brain drain. Brain drain can be avoided in favor of local implementation of scientific projects. Our results illustrate that it is feasible to educate and guide scientists with the help of telematics infrastructures.

Evaluating Por Nuestra Salud: A Feasibility Study.

PubMed

Marshall, Brenda; Gonzales, Gustavo; Kernan, William

2016-01-01

This feasibility study evaluated the impact of a culturally consistent diabetes educational program, led by a Latino pastor, on Latino community diabetes knowledge levels. Latino adults were recruited from two churches serving Latino populations, one identified as intervention, the other as nonintervention. Both churches received the American Diabetes Association's booklets on diabetes education, "Four Steps to Control Your Diabetes for Life." The intervention group also received weekly reviews of the booklet's information from the church pastor, who was educated about diabetes by a Latino family nurse practitioner. Pre- and postintervention levels of diabetes knowledge were measured using the Diabetes Knowledge Questionnaire. Mean changes in the Diabetes Knowledge Questionnaire (DKQ-24) survey from pretest to posttest indicated a significant increase in knowledge in both groups. Only the grades for the participants from the pastor-led group, however, moved from failure in knowledge to high levels of passing. One hundred percent of intervention group participants reported having read the literature. This pilot study supports the feasibility of a local Latino pastor, as a culturally consistent diabetes educator, to increase Latino parishioner's knowledge of diabetes. © 2015 Society for Public Health Education.

Feasibility and Safety of Substituting Lung Ultrasonography for Chest Radiography When Diagnosing Pneumonia in Children: A Randomized Controlled Trial.

PubMed

Jones, Brittany Pardue; Tay, Ee Tein; Elikashvili, Inna; Sanders, Jennifer E; Paul, Audrey Z; Nelson, Bret P; Spina, Louis A; Tsung, James W

2016-07-01

Chest radiography (CXR) is the test of choice for diagnosing pneumonia. Lung ultrasonography (LUS) has been shown to be accurate for diagnosing pneumonia in children and may be an alternative to CXR. Our objective was to determine the feasibility and safety of substituting LUS for CXR when evaluating children suspected of having pneumonia. We conducted a randomized control trial comparing LUS with CXR in 191 children from birth to 21 years of age suspected of having pneumonia in an ED. Patients in the investigational arm underwent LUS. If there was clinical uncertainty after ultrasonography, physicians had the option to perform CXR. Patients in the control arm underwent sequential imaging with CXR followed by LUS. The primary outcome was the rate of CXR reduction; secondary outcomes were missed pneumonia, subsequent unscheduled health-care visits, and adverse events between the investigational and control arms. There was a 38.8% reduction (95% CI, 30.0%-48.9%) in CXR among investigational subjects compared with no reduction (95% CI, 0.0%-3.6%) in the control group. Novice and experienced physician-sonologists achieved 30.0% and 60.6% reduction in CXR use, respectively. There were no cases of missed pneumonia among all study participants (investigational arm, 0.0%: 95% CI, 0.0%-2.9%; control arm, 0.0%: 95% CI, 0.0%-3.0%), or differences in adverse events, or subsequent unscheduled health-care visits between arms. It may be feasible and safe to substitute LUS for CXR when evaluating children suspected of having pneumonia with no missed cases of pneumonia or increase in rates of adverse events. ClinicalTrials.gov; No.: NCT01654887; URL: www.clinicaltrials.gov. Copyright © 2016 The Authors. Published by Elsevier Inc. All rights reserved.

A feasibility assessment of nuclear reactor power system concepts for the NASA Growth Space Station

NASA Technical Reports Server (NTRS)

Bloomfield, H. S.; Heller, J. A.

1986-01-01

A preliminary feasibility assessment of the integration of reactor power system concepts with a projected growth Space Station architecture was conducted to address a variety of installation, operational, disposition and safety issues. A previous NASA sponsored study, which showed the advantages of Space Station - attached concepts, served as the basis for this study. A study methodology was defined and implemented to assess compatible combinations of reactor power installation concepts, disposal destinations, and propulsion methods. Three installation concepts that met a set of integration criteria were characterized from a configuration and operational viewpoint, with end-of-life disposal mass identified. Disposal destinations that met current aerospace nuclear safety criteria were identified and characterized from an operational and energy requirements viewpoint, with delta-V energy requirement as a key parameter. Chemical propulsion methods that met current and near-term application criteria were identified and payload mass and delta-V capabilities were characterized. These capabilities were matched against concept disposal mass and destination delta-V requirements to provide a feasibility of each combination.

A Feasibility Study of Youth Apprenticeship in Arkansas.

ERIC Educational Resources Information Center

Jobs for the Future, Inc., West Somerville, MA.

A study assessed the feasibility and attractiveness of youth apprenticeship in Arkansas in over 80 interviews with employers in 5 key Arkansas industries and occupations. They were allied health, food processing (equipment repair and maintenance and lab technician/quality control), information services, metalworking, and self-employment and…

Feasibility Study of Training Environmental Technicians. Final Report.

ERIC Educational Resources Information Center

Vernon, James Y.; Garrett, Donald M.

A feasibility study and task analysis was performed to determine the future job potential within the Southern California area for environmental technicians trained under a proposed vocational training program in community colleges. Questionnaires were mailed to possible employers in government and industry to obtain information about their…

Distance Learning Enrollments in Independent Institutions. Feasibility Study.

ERIC Educational Resources Information Center

Washington State Higher Education Coordinating Board, Olympia.

This study investigated the feasibility of collecting enrollment data on distance learning programs sponsored by private institutions within and outside of Washington State. E-commerce developments have allowed in-state independent providers and out-of-state public institutions to serve residents of Washington State, and many nontraditional…

Technical Analysis Feasibility Study on Smart Microgrid System in Sekolah Tinggi Teknik PLN

NASA Astrophysics Data System (ADS)

Suyanto, Heri

2018-02-01

Nowadays application of new and renewable energy as main resource of power plant has greatly increased. High penetration of renewable energy into the grid will influence the quality and reliability of the electricity system, due to the intermittent characteristic of new and renewable energy resources. Smart grid or microgrid technology has the ability to deal with this intermittent characteristic especially if these renewable energy resources integrated to grid in large scale, so it can improve the reliability and efficiency of the grid. We plan to implement smart microgrid system at Sekolah Tinggi Teknik PLN as a pilot project. Before the pilot project start, the feasibility study must be conducted. In this feasibility study, the renewable energy resources and load characteristic at the site will be measured. Then the technical aspect of this feasibility study will be analyzed. This paper explains that analysis of ths feasibility study.

Feasibility study of solid surface subreflector production techniques

NASA Technical Reports Server (NTRS)

1982-01-01

The principal effort was to study technical feasibility and cost aspects of the production technique of spin forming a subreflector reflective surface to a desired surface of revolution, back the surface with fiberglass to stabilize it sufficiently so that it may be machined to the target surface tolerance of .008 inches Root Mean Square (RMS) with a goal of .003 inches RMS. To verify this production technique, analyses was performed to define the production procedure. A price estimate for a 150 inch diameter subreflector for a 34 meter cassegrain antenna. During this feasibility study, numerous production processes were evaluated theoretically as production approaches for single surface, non-welded subreflectors. The first successful was the principal process of spin forming the reflective surface, backing with fiberglass and machining to a final contour. The second successful process was spin forming or bump forming a thicker reflective surface, with an integral (welded in) structure as a backing and machining the mounting pads and reflector to a final configuration.

Defining Feasibility and Pilot Studies in Preparation for Randomised Controlled Trials: Development of a Conceptual Framework.

PubMed

Eldridge, Sandra M; Lancaster, Gillian A; Campbell, Michael J; Thabane, Lehana; Hopewell, Sally; Coleman, Claire L; Bond, Christine M

2016-01-01

We describe a framework for defining pilot and feasibility studies focusing on studies conducted in preparation for a randomised controlled trial. To develop the framework, we undertook a Delphi survey; ran an open meeting at a trial methodology conference; conducted a review of definitions outside the health research context; consulted experts at an international consensus meeting; and reviewed 27 empirical pilot or feasibility studies. We initially adopted mutually exclusive definitions of pilot and feasibility studies. However, some Delphi survey respondents and the majority of open meeting attendees disagreed with the idea of mutually exclusive definitions. Their viewpoint was supported by definitions outside the health research context, the use of the terms 'pilot' and 'feasibility' in the literature, and participants at the international consensus meeting. In our framework, pilot studies are a subset of feasibility studies, rather than the two being mutually exclusive. A feasibility study asks whether something can be done, should we proceed with it, and if so, how. A pilot study asks the same questions but also has a specific design feature: in a pilot study a future study, or part of a future study, is conducted on a smaller scale. We suggest that to facilitate their identification, these studies should be clearly identified using the terms 'feasibility' or 'pilot' as appropriate. This should include feasibility studies that are largely qualitative; we found these difficult to identify in electronic searches because researchers rarely used the term 'feasibility' in the title or abstract of such studies. Investigators should also report appropriate objectives and methods related to feasibility; and give clear confirmation that their study is in preparation for a future randomised controlled trial designed to assess the effect of an intervention.

Florida Tech CubeSat Experiment Feasibility Study

NASA Technical Reports Server (NTRS)

Arrasmith, William W.; Bucaille, Stephane; Rusovici, Razvan; Platt, Don; Guidry, Todd; Bandar, Deepika; Coots, Everett; Davidson, Russ

2010-01-01

CubeSats are a relatively new type of satellite. Smaller than long-term (5+ year life expectancy) satellites, these pico-satellites are comparatively cheap, small (10x10x10 cm), and are very versatile. Universities world-wide are using CubeSats to conduct a variety of experiments in space without the need for a large experimental platform. Today CubeSats are considered to be one of the most effective ways to send a small payload into space and has attracted the attention of many educational and non-profit organizations. As this pico-satellite model continues to gain penetration into the satellite build and launch industry, it is expected that more governmental, educational, and commercial interests will emerge. As an example, more of the space-related items of high interest to the National Science Foundation may be tackled with a CubeSat platform resulting in lower life cycle costs than traditional satellite options. NASA LSP, in cooperation with the Florida Institute of Technology, has initiated a feasibility study to investigate the technical aspects of measuring and transferring vibration, acceleration, temperature, and video data from a CubeSat to NASA Hanger AE on Cape Canaveral Air Force Station (CCAFS) a.k.a. Kennedy Space Center (KSC). This report provides a technical feasibility analysis to determine whether-or-not a specific set of NASA/LSP requirements can be accomplished. Our approach has been to provide a "notional" component layout to determine the feasibility of the NASA/LSP stakeholder requirements. The notional layout is used to consider component level technical issues such as size, weight, & power (SWaP), bandwidth, and other critical technical parameters. Even though the notional components may satisfy the stated requirements and thereby demonstrate feasibility, the notional layout is NOT considered a design since no component optimization and design trade-off analysis has taken place. This activity should be accomplished in an appropriate

A Feasibility Study of Neoadjuvant XELOX Without Radiotherapy for Locally Advanced Lower Rectal Cancer.

PubMed

Ueki, Takashi; Manabe, Tatsuya; Inoue, Shigetaka; Ienaga, Jun; Yamanaka, Naoki; Egami, Takuya; Ishikawa, Mikimasa; Konomi, Hiroyuki; Ikubo, Akashi; Nagayoshi, Kinuko; Nakamura, Masafumi; Tanaka, Masao

2016-02-01

This study was planned to evaluate the efficacy and safety of preoperative capecitabine and oxaliplatin (XELOX) without radiation in patients with locally advanced lower rectal cancer. Patients with clinical stage II/III lower rectal cancer underwent three cycles of XELOX followed by radical surgery. The primary end-point was the R0 resection rate. Thirty-one patients were recruited between February 2012 and August 2014. The completion rate of neoadjuvant chemotherapy was 96.5% among the 29 patients who received it; the remaining two refused chemotherapy and underwent immediate surgery. Grade 3-4 adverse events occurred in nine patients (31%). All 29 patients who received chemotherapy underwent radical resection. The R0 resection rate was 96.5% among these 29 patients. Pathological complete responses were achieved in three patients (10.3%) and downstaging occurred in 13 (44.8%). This pilot study found that neoadjuvant XELOX for locally advanced lower rectal cancer is feasible and safe. This neoadjuvant treatment improved resection margin status. Copyright© 2016 International Institute of Anticancer Research (Dr. John G. Delinassios), All rights reserved.

Adaptation and Feasibility Study of a Digital Health Program to Prevent Diabetes among Low-Income Patients: Results from a Partnership between a Digital Health Company and an Academic Research Team

PubMed Central

McDermott, Kelly; Tieu, Lina; Rios, Christina; Gibson, Eliza; Sweet, Cynthia Castro; Payne, Mike

2016-01-01

Background. The feasibility of digital health programs to prevent and manage diabetes in low-income patients has not been adequately explored. Methods. Researchers collaborated with a digital health company to adapt a diabetes prevention program for low-income prediabetes patients at a large safety net clinic. We conducted focus groups to assess patient perspectives, revised lessons for improved readability and cultural relevance to low-income and Hispanic patients, conducted a feasibility study of the adapted program in English and Spanish speaking cohorts, and implemented real-time adaptations to the program for commercial use and for a larger trial of in multiple safety net clinics. Results. The majority of focus group participants were receptive to the program. We modified the curriculum to a 5th-grade reading level and adapted content based on patient feedback. In the feasibility study, 54% of eligible contacted patients expressed interest in enrolling (n = 23). Although some participants' computer access and literacy made registration challenging, they were highly satisfied and engaged (80% logged in at least once/week). Conclusions. Underserved prediabetic patients displayed high engagement and satisfaction with a digital diabetes prevention program despite lower digital literacy skills. The collaboration between researchers and a digital health company enabled iterative improvements in technology implementation to address challenges in low-income populations. PMID:27868070

[Should we establish patient safety leadership walkrounds? A systematic review].

PubMed

Girerd-Genessay, I; Michel, P

2015-10-01

Used for over a decade, patient safety leadership walkrounds (PSLWs) is a managerial method designed to enhance the implementation of safety measures in hospitals. In order to determine the effect of PSLWs in French hospitals, we reviewed the literature on participant perceptions and the impact of PSLW on the overall culture of safety. We conducted a systematic review of articles assessing the impact of PSLWs on the culture of safety (comparative studies) or the perceptions of caregivers and managers (qualitative studies). Five studies investigating safety culture and three studies investigating participant perception were identified. PSLWs were associated with an improvement in safety culture and the overall safety climate. The presence of caregivers during the PSLWs was important to achieve improvement. PSLWs improved the dialogue between caregivers and managers, and improved knowledge on care safety. Some problems concerning managerial PSLW attendance and counter-productive attitudes have occasionally been reported. PSLWs improve safety culture. Their effectiveness depends on the way they are implemented. They should initially be tested in France to ensure their feasibility and acceptability in our healthcare system. Copyright © 2015 Elsevier Masson SAS. All rights reserved.

Feasibility and Safety of Intra-arterial Pericyte Progenitor Cell Delivery Following Mannitol-Induced Transient Blood-Brain Barrier Opening in a Canine Model.

PubMed

Youn, Sung Won; Jung, Keun-Hwa; Chu, Kon; Lee, Jong-Young; Lee, Soon-Tae; Bahn, Jae-jun; Park, Dong-Kyu; Yu, Jung-Suk; Kim, So-Yun; Kim, Manho; Lee, Sang Kun; Han, Moon-Hee; Roh, Jae-Kyu

2015-01-01

Stem cell therapy is currently being studied with a view to rescuing various neurological diseases. Such studies require not only the discovery of potent candidate cells but also the development of methods that allow optimal delivery of those candidates to the brain tissues. Given that the blood-brain barrier (BBB) precludes cells from entering the brain, the present study was designed to test whether hyperosmolar mannitol securely opens the BBB and enhances intra-arterial cell delivery. A noninjured normal canine model in which the BBB was presumed to be closed was used to evaluate the feasibility and safety of the tested protocol. Autologous adipose tissue-derived pericytes with platelet-derived growth factor receptor β positivity were utilized. Cells were administered 5 min after mannitol pretreatment using one of following techniques: (1) bolus injection of a concentrated suspension, (2) continuous infusion of a diluted suspension, or (3) bolus injection of a concentrated suspension that had been shaken by repeated syringe pumping. Animals administered a concentrated cell suspension without mannitol pretreatment served as a control group. Vital signs, blood parameters, neurologic status, and major artery patency were kept stable throughout the experiment and the 1-month posttreatment period. Although ischemic lesions were noted on magnetic resonance imaging in several mongrel dogs with concentrated cell suspension, the injection technique using repeated syringe shaking could avert this complication. The cells were detected in both ipsilateral and contralateral cortices and were more frequent at the ipsilateral and frontal locations, whereas very few cells were observed anywhere in the brain when mannitol was not preinjected. These data suggest that intra-arterial cell infusion with mannitol pretreatment is a feasible and safe therapeutic approach in stable brain diseases such as chronic stroke.

Opto-acoustic image fusion technology for diagnostic breast imaging in a feasibility study

NASA Astrophysics Data System (ADS)

Zalev, Jason; Clingman, Bryan; Herzog, Don; Miller, Tom; Ulissey, Michael; Stavros, A. T.; Oraevsky, Alexander; Lavin, Philip; Kist, Kenneth; Dornbluth, N. C.; Otto, Pamela

2015-03-01

Functional opto-acoustic (OA) imaging was fused with gray-scale ultrasound acquired using a specialized duplex handheld probe. Feasibility Study findings indicated the potential to more accurately characterize breast masses for cancer than conventional diagnostic ultrasound (CDU). The Feasibility Study included OA imagery of 74 breast masses that were collected using the investigational Imagio® breast imaging system. Superior specificity and equal sensitivity to CDU was demonstrated, suggesting that OA fusion imaging may potentially obviate the need for negative biopsies without missing cancers in a certain percentage of breast masses. Preliminary results from a 100 subject Pilot Study are also discussed. A larger Pivotal Study (n=2,097 subjects) is underway to confirm the Feasibility Study and Pilot Study findings.

Feasibility study: Assess the feasibility of siting a monitored retrievable storage facility. Phase 1

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

King, J.W.

1993-08-01

The purpose of phase one of this study are: To understand the waste management system and a monitored retrievable storage facility; and to determine whether the applicant has real interest in pursuing the feasibility assessment process. Contents of this report are: Generating electric power; facts about exposure to radiation; handling storage, and transportation techniques; description of a proposed monitored retrievable storage facility; and benefits to be received by host jurisdiction.

Feasibility study of full-reactor gas core demonstration test

NASA Technical Reports Server (NTRS)

Kunze, J. F.; Lofthouse, J. H.; Shaffer, C. J.; Macbeth, P. J.

1973-01-01

Separate studies of nuclear criticality, flow patterns, and thermodynamics for the gas core reactor concept have all given positive indications of its feasibility. However, before serious design for a full scale gas core application can be made, feasibility must be shown for operation with full interaction of the nuclear, thermal, and hydraulic effects. A minimum sized, and hence minimum expense, test arrangement is considered for a full gas core configuration. It is shown that the hydrogen coolant scattering effects dominate the nuclear considerations at elevated temperatures. A cavity diameter of somewhat larger than 4 ft (122 cm) will be needed if temperatures high enough to vaporize uranium are to be achieved.

Patient Safety Policy in Long-Term Care: A Research Protocol to Assess Executive WalkRounds to Improve Management of Early Warning Signs for Patient Safety.

PubMed

van Dusseldorp, Loes; Hamers, Hub; van Achterberg, Theo; Schoonhoven, Lisette

2014-07-15

At many hospitals and long-term care organizations (such as nursing homes), executive board members have a responsibility to manage patient safety. Executive WalkRounds offer an opportunity for boards to build a trusting relationship with professionals and seem useful as a leadership tool to pick up on soft signals, which are indirect signals or early warnings that something is wrong. Because the majority of the research on WalkRounds has been performed in hospitals, it is unknown how board members of long-term care organizations develop their patient safety policy. Also, it is not clear if these board members use soft signals as a leadership tool and, if so, how this influences their patient safety policies. The objective of this study is to explore the added value and the feasibility of WalkRounds for patient safety management in long-term care. This study also aims to identify how executive board members of long-term care organizations manage patient safety and to describe the characteristics of boards. An explorative before-and-after study was conducted between April 2012 and February 2014 in 13 long-term care organizations in the Netherlands. After implementing the intervention in 6 organizations, data from 72 WalkRounds were gathered by observation and a reporting form. Before and after the intervention period, data collection included interviews, questionnaires, and studying reports of the executive boards. A mixed-method analysis is performed using descriptive statistics, t tests, and content analysis. Results are expected to be ready in mid 2014. It is a challenge to keep track of ongoing development and implementation of patient safety management tools in long-term care. By performing this study in cooperation with the participating long-term care organizations, insight into the potential added value and the feasibility of this method will increase.

[Feasibility and relevance of an operating room safety checklist for developing countries: Study in a French hospital in Djibouti].

PubMed

Becret, A; Clapson, P; Andro, C; Chapelier, X; Gauthier, J; Kaiser, E

2013-01-01

The use of the World Health Organization surgical safety checklist, mandatory in operating rooms (OR) in France, significantly reduces morbidity and mortality. Our objective was to evaluate the use of this checklist in the OR of a French military hospital in Djibouti (Horn of Africa). The study was performed in three stages: a retrospective evaluation of the checklist use over the previous two months, to assess the utilization and completeness rates; provision of information to the OR staff; and thereafter, prospective evaluation for a one-month period of checklist use, the reasons for non-compliance, and the cases in which the checklist identified errors and thus prevented serious adverse events. The initial utilization rate was 49%, with only 24% complete. After staff training and during the study these rates reached 100% and 99%. The staff encountered language difficulties in 53% of cases, and an interpreter was available for 81% of them. The capacity of the surgical safety checklist to detect serious adverse events was highlighted. The utilization and completeness rates were initially worse than those observed in metropolitan French ORs, but a simple staff information program was rapidly effective. Language difficulties are frequent but an interpreter is often available, unlike in developed countries where language problems are uncommon and the availability of interpreters difficult. Moreover, this study illustrates the ability of the checklist to detect and therefore prevent potentially serious adverse events.

Feasibility of cohort studies in Estonia

PubMed Central

Innos, K.; Rahu, M.; Rahu, K.

1999-01-01

OBJECTIVES: To describe the methodology and feasibility of follow up for vital status in retrospective cohort studies in Estonia. METHODS: A cohort of 7412 workers who had been employed at two factories in Tallinn between 1946 and 1988 was followed up for vital status from the date of first employment until death, emigration, or the end of the study, 31 December 1995, whichever occurred first. The cohort was electronically linked with the National Population Registry of Estonia that was created in 1992 and includes personal identification numbers of Estonian citizens and residents, and the Mortality Database that contains information from death certificates issued in 1983-95. A manual search was carried out on several non-computerised population data sources and archives. RESULTS: By 31 December 1995, the vital status of 6780 (91.5%) subjects could be traced (4495 (60.6%) subjects were alive, 1993 (26.9%) had died, and 292 (3.9%) had emigrated). Analysis by calendar period of leaving work showed that the proportion of subjects traced was lowest in the group of workers who had left work between 1946 and 1955 (58.4%), especially those whose age at leaving work was < 30 (53.2%) or > 60 years (42.3%). Among subjects who left work in 1956-65, 1966-75, and 1976-88, the follow up rate was 84.7%, 94.6%, and 98.2%, respectively. CONCLUSIONS: The findings, which are especially important for occupational epidemiology, confirm the feasibility of conducting retrospective cohort studies in Estonia. Most of the issues discussed in the paper apply to other former Soviet countries.   PMID:10472323

Feasibility study of rainwater harvesting for domestic use (Case study: West Jakarta rainfall data)

NASA Astrophysics Data System (ADS)

Kartolo, Jason; Kusumawati, Elly

2017-11-01

Rainwater Harvesting system is one of considerable choice to reduce flood in Jakarta, moreover it helps to reduce main tap water consumption. In this study, rainwater is used for flushing toilet and watering garden for domestic use. Rainwater harvesting system is examined for 60 m2 and 90 m2 housing area, using rainfall data from Cengkareng station in West Jakarta. Two type of rainwater harvesting reservoir is designed, those are ground reservoir and underground reservoir. From the analysis, it finds that 60 m2 house feasible for 1 m3 ground reservoir and 9 m3 underground reservoir. Meanwhile for 90 m2 house 2 m3 tanks ground reservoir and 14 m3 tank underground reservoir is feasible. Underground reservoir retain more water volume so it provide higher rate of water supply. The cost of underground reservoir is lower 60% - 70% than ground reservoir. Even though rainwater harvesting is technically feasible for housing, it is not economically feasible. The construction cost is higher than the benefit of reduced tap water consumption.

The Ultrasound-Guided Retroclavicular Block: A Prospective Feasibility Study.

PubMed

Charbonneau, Jasmin; Fréchette, Yannick; Sansoucy, Yanick; Echave, Pablo

2015-01-01

The aim of this feasibility study was to determine the success rate (sensory and surgical) of the novel retroclavicular block and to thoroughly describe the technique. In addition, needle tip and shaft visibility, needling time, procedural discomfort, motor block success rate, patient satisfaction at 48-hour follow-up, and complications were also recorded. Fifty patients scheduled for distal upper limb surgery received an in-plane, single-shot, ultrasound-guided retroclavicular block with 40 mL of mepivacaine 1.5% with epinephrine 2.5 μg/mL. Block success was defined as a sensory score of 10/10 for the 5 nerves supplying the distal upper limb at 30 minutes. Surgical success, needle visibility, needling time, axillary artery depth, motor block rate, patient discomfort with technique, satisfaction at 48 hours, and complications were also recorded. All blocks were video-recorded and timed for further independent assessment. A chest x-ray was obtained before discharge. Forty-five patients had a total sensory score of 10/10 at 30 minutes (90% success rate). Surgical success rate was 96%. Mean needling time was 3.77 minutes (25th-75th percentiles, 2.90-6.53 minutes) with a mean axillary artery depth of 3.1 ± 0.7 cm. Procedure-related discomfort (mean visual analog scale, 1.9 ± 1.2) was low. Mean 48-hour patient satisfaction rate (9.2 ± 1.1), mean needle tip (Likert scale, 3.0 ± 0.9), and shaft visibility (3.9 ± 0.9) were high. One vascular puncture and two transient paresthesias were recorded. No pneumothorax was revealed by chest x-ray. In this study, the novel retroclavicular block offered a quick, safe, and reliable alternative for distal arm block. Further studies, comparing this approach with the classic infraclavicular block, are required to validate its efficacy, safety, and reliability.

A 30/20 GHz FSS feasibility study

NASA Technical Reports Server (NTRS)

1987-01-01

The near term feasibility of direct-to-subscriber services were determined using the 30/20 GHz Fixed Satellite Service (FSS) frequency bands. Those technologies which need to be further developed before such a system can be implemented, were identified. To determine this feasibility, dozens of potential applications were examined for their near-term viability, and the subscriber base of three promising applications were estimated. The system requirements, terminal design, and satellite architecture were all investigated to determine whether a 30/20 GHz FSS system is technically and economically feasible by mid-1990s. It was concluded that such a system is feasible, although maturation of some technologies is needed. This system would likely consist of one or two multibeam satellites serving hub/spoke networks of simple user terminals and more complex, mutli-channel terminals of the service providers. Rain compensation would be accomplished non-adaptively through the use of coding, nonuniform satellite TWT power that is a function of a beam's anticipated downlink fading, and signal regeneration of traffic to the wettest climate regions. It was estimated that a potential market of almost two million users could exist in in the mid-1990s time frame for home banking and financial services via Ka-band satellites.

[Cambridge Conference on School Mathematics Feasibility Studies 9-13.

ERIC Educational Resources Information Center

Cambridge Conference on School Mathematics, Newton, MA.

These materials are a part of a series of studies sponsored by the Cambridge Conference on School Mathematics which reflects the ideas of CCSM regarding the goals and objectives for school mathematics K-12. Feasibility Studies 9-13 contain a wide range of topics. The following are the titles and brief descriptions of these studies. Number…

Space shuttle/food system study. Package feasibility study, modifications 3S, 4C and 5S

NASA Technical Reports Server (NTRS)

1974-01-01

An optimum feeding system for the space shuttle was presented. This system consisted of all rehydratable type foods which were enclosed in a 4 in. x 4 in. x 1 in. flexible package. A feasibility follow-on study was conducted, and two acceptable, feasible prototypes for this package are described.

A Feasibility Study on Data Distribution on Optical Media.

ERIC Educational Resources Information Center

Campbell (Bonnie) & Associates, Toronto (Ontario).

This feasibility study assesses the potential of optical technology in the development of accessible bibliographic and location data networks both in Canada and within the international MARC (Machine-Readable Cataloging) network. The study is divided into four parts: (1) a market survey of cataloging and interlibrary loan librarians to determine…

Railway safety climate: a study on organizational development.

PubMed

Cheng, Yung-Hsiang

2017-09-07

The safety climate of an organization is considered a leading indicator of potential risk for railway organizations. This study adopts the perceptual measurement-individual attribute approach to investigate the safety climate of a railway organization. The railway safety climate attributes are evaluated from the perspective of railway system staff. We identify four safety climate dimensions from exploratory factor analysis, namely safety communication, safety training, safety management and subjectively evaluated safety performance. Analytical results indicate that the safety climate differs at vertical and horizontal organizational levels. This study contributes to the literature by providing empirical evidence of the multilevel safety climate in a railway organization, presents possible causes of the differences under various cultural contexts and differentiates between safety climate scales for diverse workgroups within the railway organization. This information can be used to improve the safety sustainability of railway organizations and to conduct safety supervisions for the government.

Environmental pollution and shipping feasibility of the Nicaragua Canal.

PubMed

Chen, Jihong; Zeng, Xin; Deng, Yibing

2016-12-15

In recent years, the Nicaraguan government's renewed interest in constructing this interoceanic canal has once again aroused widespread concern, particularly in the global shipping industry. The project's immense ecological risks, coupled with the recent expansions of both the Panama Canal and the Suez Canal, have raised questions among scientists and experts about its viability. Whether the Nicaragua Canal is really feasible for international shipping, given its high marine pollution risks, requires the further study. This paper discusses and analyses the feasibility of the Nicaragua Canal in the context of its environmental impact and value as a shipping service. This paper aims to provide an important information reference to inform strategic decision-making among policymakers and stakeholders. Our research results indicate that the environmental complexity, economic costs and safety risks of building a new transoceanic canal are simply too high to justify the project. Copyright © 2016 Elsevier Ltd. All rights reserved.

Safety distance assessment of industrial toxic releases based on frequency and consequence: a case study in Shanghai, China.

PubMed

Yu, Q; Zhang, Y; Wang, X; Ma, W C; Chen, L M

2009-09-15

A case study on the safety distance assessment of a chemical industry park in Shanghai, China, is presented in this paper. Toxic releases were taken into consideration. A safety criterion based on frequency and consequence of major hazard accidents was set up for consequence analysis. The exposure limits for the accidents with the frequency of more than 10(-4), 10(-5)-10(-4) and 10(-6)-10(-5) per year were mortalities of 1% (or SLOT), 50% (SLOD) and 75% (twice of SLOD) respectively. Accidents with the frequency of less than 10(-6) per year were considered incredible and ignored in the consequence analysis. Taking the safety distance of all the hazard installations in a chemical plant into consideration, the results based on the new criterion were almost smaller than those based on LC50 or SLOD. The combination of the consequence and risk based results indicated that the hazard installations in two of the chemical plants may be dangerous to the protection targets and measurements had to be taken to reduce the risk. The case study showed that taking account of the frequency of occurrence in the consequence analysis would give more feasible safety distances for major hazard accidents and the results were more comparable to those calculated by risk assessment.

Left Atrial Appendage Electrical Isolation and Concomitant Device Occlusion to Treat Persistent Atrial Fibrillation: A First-in-Human Safety, Feasibility, and Efficacy Study.

PubMed

Panikker, Sandeep; Jarman, Julian W E; Virmani, Renu; Kutys, Robert; Haldar, Shouvik; Lim, Eric; Butcher, Charles; Khan, Habib; Mantziari, Lilian; Nicol, Edward; Foran, John P; Markides, Vias; Wong, Tom

2016-07-01

Left atrial appendage (LAA) electric isolation is reported to improve persistent atrial fibrillation (AF) ablation outcomes. However, loss of LAA mechanical function may increase thromboembolic risk. Concomitant LAA electric isolation and occlusion as part of conventional AF ablation has never been tested in humans. We therefore evaluated the feasibility, safety, and efficacy of LAA electric isolation and occlusion in patients undergoing long-standing persistent AF ablation. Patients with long-standing persistent AF (age, 68±7 years; left atrium diameter, 46±3 mm; and AF duration, 25±15 months) underwent AF ablation, LAA electric isolation, and occlusion. Outcomes were compared with a balanced (1:2 ratio) control group who had AF ablation alone. Among 22 patients who underwent ablation, LAA electric isolation was possible in 20. Intraprocedural LAA reconnection occurred in 17 of 20 (85%) patients, predominantly at anterior and superior locations. All were reisolated. LAA occlusion was successful in all 20 patients. There were no major periprocedural complications. Imaging at 45 days and 9 months confirmed satisfactory device position and excluded pericardial effusion. One of twenty (5%) patients had a gap of ≥5 mm requiring anticoagulation. Nineteen of twenty (95%) patients stopped warfarin at 3 months. Without antiarrhythmic drugs, freedom from AF at 12 months after a single procedure was significantly higher in the study group (19/20, 95%) than in the control group (25/40, 63%), P=0.036. Freedom from atrial arrhythmias was demonstrated in 12 of 20 (60%) and 18 of 20 (90%) patients after 1 and ≤2 procedures (mean, 1.3), respectively. Persistent AF ablation, LAA electric isolation, and mechanical occlusion can be performed concomitantly. This technique may improve the success of persistent AF ablation while obviating the need for chronic anticoagulation. URL: https://clinicaltrials.gov. Unique identifier: NCT02028130. © 2016 American Heart Association, Inc.

Exploring Ways to Implement the Health Services Mobility Study: A Feasibility Study.

ERIC Educational Resources Information Center

Lavine, Eileen M.; Moore, Audrey

A feasibility study was aimed at developing a strategy for implementing and utilizing the job analysis methodology which resulted from the Health Services Mobility Study (HSMS), particularly as it can be applied to the field of diagnostic radiology. (The HSMS method of job analysis starts with task descriptions analyzing the tasks that make up a…

A feasibility study: Forest Fire Advanced System Technology (FFAST)

NASA Technical Reports Server (NTRS)

Mcleod, R. G.; Martin, T. Z.; Warren, J.

1983-01-01

The National Aeronautics and Space Administration/Jet Propulsion Laboratory and the United States Department of Agriculture Forest Service completed a feasibility study that examined the potential uses of advanced technology in forest fires mapping and detection. The current and future (1990's) information needs in forest fire management were determined through interviews. Analysis shows that integrated information gathering and processing is needed. The emerging technologies that were surveyed and identified as possible candidates for use in an end to end system include ""push broom'' sensor arrays, automatic georeferencing, satellite communication links, near real or real time image processing, and data integration. Matching the user requirements and the technologies yielded a ""strawman'' system configuration. The feasibility study recommends and outlines the implementation of the next phase for this project, a two year, conceptual design phase to define a system that warrants continued development.

Usability and Feasibility of an Internet-Based Virtual Pedestrian Environment to Teach Children to Cross Streets Safely

PubMed Central

Schwebel, David C.; McClure, Leslie A.; Severson, Joan

2013-01-01

Child pedestrian injury is a preventable global health challenge. Successful training efforts focused on child behavior, including individualized streetside training and training in large virtual pedestrian environments, are laborious and expensive. This study considers the usability and feasibility of a virtual pedestrian environment “game” application to teach children safe street-crossing behavior via the internet, a medium that could be broadly disseminated at low cost. Ten 7- and 8-year-old children participated. They engaged in an internet-based virtual pedestrian environment and completed a brief assessment survey. Researchers rated children's behavior while engaged in the game. Both self-report and researcher observations indicated the internet-based system was readily used by the children without adult support. The youth understood how to engage in the system and used it independently and attentively. The program also was feasible. It provided multiple measures of pedestrian safety that could be used for research or training purposes. Finally, the program was rated by children as engaging and educational. Researcher ratings suggested children used the program with minimal fidgeting or boredom. The pilot test suggests an internet-based virtual pedestrian environment offers a usable, feasible, engaging, and educational environment for child pedestrian safety training. If future research finds children learn the cognitive and perceptual skills needed to cross streets safely within it, internet-based training may provide a low-cost medium to broadly disseminate child pedestrian safety training. The concept may be generalized to other domains of health-related functioning such as teen driving safety, adolescent sexual risk-taking, and adolescent substance use. PMID:24678263

Safety, acceptability, and feasibility of a single-visit approach to cervical-cancer prevention in rural Thailand: a demonstration project.

PubMed

Gaffikin, L; Blumenthal, P D; Emerson, M; Limpaphayom, K

2003-03-08

To increase screening and treatment coverage, innovative approaches to cervical-cancer prevention are being investigated in rural Thailand. We assessed the value of a single-visit approach combining visual inspection of the cervix with acetic acid wash (VIA) and cryotherapy. 12 trained nurses provided services in mobile (village health centre-based) and static (hospital-based) teams in four districts of Roi-et Province, Thailand. Over 7 months, 5999 women were tested by VIA. If they tested positive, after counselling about the benefits, potential risks, and probable side-effects they were offered cryotherapy. Data measuring safety, acceptability, feasibility, and effort to implement the programme were gathered. The VIA test-positive rate was 13.3% (798/5999), and 98.5% (609/618) of those eligible accepted immediate treatment. Overall, 756 women received cryotherapy, 629 (83.2%) of whom returned for their first follow-up visit. No major complications were recorded, and 33 (4.4%) of those treated returned for a perceived problem. Only 17 (2.2%) of the treated women needed clinical management other than reassurance about side-effects. Both VIA and cryotherapy were highly acceptable to the patients (over 95% expressed satisfaction with their experience). At their 1-year visit, the squamocolumnar junction was visible to the nurses, and the VIA test-negative rate was 94.3%. A single-visit approach with VIA and cryotherapy seems to be safe, acceptable, and feasible in rural Thailand, and is a potentially efficient method of cervical-cancer prevention in such settings.

How to Train an Injured Brain? A Pilot Feasibility Study of Home-Based Computerized Cognitive Training.

PubMed

Verhelst, Helena; Vander Linden, Catharine; Vingerhoets, Guy; Caeyenberghs, Karen

2017-02-01

Computerized cognitive training programs have previously shown to be effective in improving cognitive abilities in patients suffering from traumatic brain injury (TBI). These studies often focused on a single cognitive function or required expensive hardware, making it difficult to be used in a home-based environment. This pilot feasibility study aimed to evaluate the feasibility of a newly developed, home-based, computerized cognitive training program for adolescents who suffered from TBI. Additionally, feasibility of study design, procedures, and measurements were examined. Case series, longitudinal, pilot, feasibility intervention study with one baseline and two follow-up assessments. Nine feasibility outcome measures and criteria for success were defined, including accessibility, training motivation/user experience, technical smoothness, training compliance, participation willingness, participation rates, loss to follow-up, assessment timescale, and assessment procedures. Five adolescent patients (four boys, mean age = 16 years 7 months, standard deviation = 9 months) with moderate to severe TBI in the chronic stage were recruited and received 8 weeks of cognitive training with BrainGames. Effect sizes (Cohen's d) were calculated to determine possible training-related effects. The new cognitive training intervention, BrainGames, and study design and procedures proved to be feasible; all nine feasibility outcome criteria were met during this pilot feasibility study. Estimates of effect sizes showed small to very large effects on cognitive measures and questionnaires, which were retained after 6 months. Our pilot study shows that a longitudinal intervention study comprising our novel, computerized cognitive training program and two follow-up assessments is feasible in adolescents suffering from TBI in the chronic stage. Future studies with larger sample sizes will evaluate training-related effects on cognitive functions and underlying brain structures.

75 FR 43942 - Children's Products Containing Lead; Technological Feasibility of 100 ppm for Lead Content...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-07-27

...Section 101(a) of the Consumer Product Safety Improvement Act (``CPSIA'') provides that, as of August 11, 2011, children's products may not contain more than 100 parts per million (``ppm'') of lead, unless the Consumer Product Safety Commission (``CPSC'' or ``Commission''), determines that it is not technologically feasible, after notice and a hearing and after analyzing the public health protections associated with substantially reducing lead in children's products. The reduction can be for a product or product category. This notice requests comment and information on the technological feasibility of meeting the 100 ppm lead content limit for children's products.

The perceived feasibility and acceptability of a conceptually challenging exercise training program in older adults.

PubMed

Miller, Clint T; Teychenne, Megan; Maple, Jaimie-Lee

2018-01-01

Exercise training is an essential component of falls prevention strategies, but they do not fully address components of physical function that leads to falls. The training approaches to achieve this may not be perceived as appropriate or even feasible in older adults. This study aims to assess the perceived feasibility and acceptability of novel exercise training approaches not usually prescribed to older adults. Fourteen adults were exposed to conceptually and physically demanding exercises. Interviews were then conducted to determine perceptions and acceptability of individual exercise tasks. Qualitative thematic analysis was used to identify themes. Safety and confidence, acceptability, and population participation were the key themes identified. Staff knowledge, presence, program design, and overt safety equipment were important for alleviating initial apprehension. Although physically demanding, participants expressed satisfaction when challenged. Prior disposition, understanding the value, and the appeal of novel exercises were perceived to influence program engagement. Given the evidence for acceptability, this type of training is feasible and may be appropriate as part of an exercise training program for older adults. Further research should be conducted to confirm that the physical adaptations to exercise training approaches as presented in this study occur in a similar manner to that observed in younger adults, and to also determine whether these adaptations lead to prolonged independence and reduced falls in older adults compared to usual care.

Simulating geriatric home safety assessments in a three-dimensional virtual world.

PubMed

Andrade, Allen D; Cifuentes, Pedro; Mintzer, Michael J; Roos, Bernard A; Anam, Ramanakumar; Ruiz, Jorge G

2012-01-01

Virtual worlds could offer inexpensive and safe three-dimensional environments in which medical trainees can learn to identify home safety hazards. Our aim was to evaluate the feasibility, usability, and acceptability of virtual worlds for geriatric home safety assessments and to correlate performance efficiency in hazard identification with spatial ability, self-efficacy, cognitive load, and presence. In this study, 30 medical trainees found the home safety simulation easy to use, and their self-efficacy was improved. Men performed better than women in hazard identification. Presence and spatial ability were correlated significantly with performance. Educators should consider spatial ability and gender differences when implementing virtual world training for geriatric home safety assessments.

Closure of tubular patent ductus arteriosus with the Amplatzer Vascular Plug IV: feasibility and safety.

PubMed

Baruteau, Alban-Elouen; Lambert, Virginie; Riou, Jean-Yves; Angel, Claude-Yves; Belli, Emre; Petit, Jérôme

2015-01-01

Closure of tubular patent ductus arteriosus remains a challenging procedure. Anecdotal use of Amplatzer Vascular Plug IV for tubular ductus closure has been reported but feasibility and safety in a consecutive patients' series remain unknown. We performed a monocenter prospective study at the Marie Lannelongue Hospital in Paris, France. From 2009 to 2014, a total of 47 patients (39 infants, 3 children, and 5 adults) underwent ductus closure with the Plug IV. Ductus morphology was a type E in 34 (72.3%) patients and a type C in 13 (27.7%) patients. Ductus closure occurred in 39 (83.0%) infants at a median age of seven months (range: 3-23 months) and a median weight of 6.9 kg (range: 4.1-17.0 kg). A past history of prematurity and very low birth weight was found in 33 (70.2%) of them. Twelve (25.5%) patients had pulmonary hypertension. Mean Plug IV diameter was 1.9 ± 0.1 mm larger than the mean maximal ductus diameter. Early complete closure of the ductus was obtained in all patients. Early migration of an undersized Plug IV occurred in one (2.1%) patient and was suitable for percutaneous device retrieval. After a mean follow-up of 3.4 ± 1.4 years, all patients are alive and asymptomatic, no late complication occurred. Transcatheter closure of tubular ductus with the Amplatzer Vascular Plug IV can be safe and effective, with a 100% early occlusion rate. This device, suitable for a 4F sheath, is a new alternative for tubular ductus closure in low-body-weight infants. © The Author(s) 2014.

Feasibility of transcranial direct current stimulation use in children aged 5 to 12 years.

PubMed

Andrade, Agnes Carvalho; Magnavita, Guilherme Moreira; Allegro, Juleilda Valéria Brasil Nunes; Neto, Carlos Eduardo Borges Passos; Lucena, Rita de Cássia Saldanha; Fregni, Felipe

2014-10-01

Transcranial direct current stimulation is a noninvasive brain stimulation technique that has been studied for the treatment of neuropsychiatric disorders in adults, with minimal side effects. The objective of this study is to report the feasibility, tolerability, and the short-term adverse effects of transcranial direct current stimulation in children from 5 to 12 years of age. It is a naturalistic study of 14 children who underwent 10 sessions of transcranial direct current stimulation as an alternative, off-label, and open-label treatment for various languages disorders. Frequency, intensity, adverse effects, and perception of improvement reported by parents were collected. The main side effects detected were tingling (28.6%) and itching (28.6%), acute mood changes (42.9%), and irritability (35.7%). Transcranial direct current stimulation is a feasible and tolerable technique in children, although studies regarding plastic and cognitive changes in children are needed to confirm its safety. In conclusion, this is a naturalistic report in which we considered transcranial direct current stimulation as feasible in children. © The Author(s) 2013.

Evaluation of the safety benefits of legacy safe routes to school programs