Prospective Assessment of Cannabis Withdrawal in Adolescents with Cannabis Dependence: A Pilot Study

ERIC Educational Resources Information Center

Milin, Robert; Manion, Ian; Dare, Glenda; Walker, Selena

2008-01-01

A study to identify and assess the withdrawal symptoms in adolescents afflicted with cannabis dependence is conducted. Results conclude that withdrawal symptoms of cannabis were present in adolescents seeking treatment for this substance abuse.

High dose vitamin D therapy for chronic pain in children and adolescents with sickle cell disease: results of a randomized double blind pilot study.

PubMed

Osunkwo, Ifeyinwa; Ziegler, Thomas R; Alvarez, Jessica; McCracken, Courtney; Cherry, Korin; Osunkwo, Chinyere E; Ofori-Acquah, Solomon F; Ghosh, Samit; Ogunbobode, Adeolu; Rhodes, Jim; Eckman, James R; Dampier, Carlton; Tangpricha, Vin

2012-10-01

We report results of a pilot study of high-dose vitamin D in sickle cell disease (SCD). Subjects were given a 6-week course of oral high-dose cholecalciferol (4000-100 000 IU per week) or placebo and monitored prospectively for a period of six months. Vitamin D insufficiency and deficiency was present at baseline in 82·5% and 52·5% of subjects, respectively. Subjects who received high-dose vitamin D achieved higher serum 25-hydroxyvitamin D, experienced fewer pain days per week, and had higher physical activity quality-of-life scores. These findings suggest a potential benefit of vitamin D in reducing the number of pain days in SCD. Larger prospective studies with longer duration are needed to confirm these effects. © 2012 Blackwell Publishing Ltd.

Coalbed-methane pilots - timing, design, and analysis

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

Roadifer, R.D.; Moore, T.R.

2009-10-15

Four distinct sequential phases form a recommended process for coalbed-methane (CBM)-prospect assessment: initial screening reconnaissance, pilot testing, and final appraisal. Stepping through these four phases provides a program of progressively ramping work and cost, while creating a series of discrete decision points at which analysis of results and risks can be assessed. While discussing each of these phases in some degree, this paper focuses on the third, the critically important pilot-testing phase. This paper contains roughly 30 specific recommendations and the fundamental rationale behind each recommendation to help ensure that a CBM pilot will fulfill its primary objectives of (1)more » demonstrating whether the subject coal reservoir will desorb and produce consequential gas and (2) gathering the data critical to evaluate and risk the prospect at the next-often most critical-decision point.« less

Supporting and improving community health services-a prospective evaluation of ECHO technology in community palliative care nursing teams.

PubMed

White, Clare; McIlfatrick, Sonja; Dunwoody, Lynn; Watson, Max

2015-12-01

Project ECHO (Extension for Community Healthcare Outcomes) uses teleconferencing technology to support and train healthcare providers (HCPs) remotely, and has improved care across the USA. A 6-month pilot was trialled in a community palliative care nursing setting to determine if ECHO would be effective in the UK in providing education and support to community hospice nurses (CHN). The pilot involved weekly 2 hour sessions of teaching and case-based discussions facilitated by hospice staff linking with nine teams of CHN using video conferencing technology. A mixed-methods prospective longitudinal cohort study was used to evaluate the pilot. Each CHN provided demographic data, and completed a written knowledge assessment and a self-efficacy tool before and after the pilot. Two focus groups were also performed after the pilot. 28 CHNs completed the evaluation. Mean knowledge score improved significantly from 71.3% to 82.7% (p=0.0005) as did overall self-efficacy scores following the ECHO pilot. Pre-ECHO (p=0.036) and Retro-Pretest ECHO (p=0.0005) self-efficacy were significantly lower than post-ECHO. There was no significant difference between Pretest and Retro-Pretest ECHO self-efficacy (p=0.063). 96% recorded gains in learning, and 90% felt that ECHO had improved the care they provided for patients. 83% would recommend ECHO to other HCPs. 70% stated the technology used in ECHO had given them access to education that would have been hard to access due to geography. This study supports the use of Project ECHO for CHNs in the UK by demonstrating how a 6-month pilot improved knowledge and self-efficacy. As a low-cost high-impact model, ECHO provides an affordable solution to addressing growing need. 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/

Clinical Practice Improvement Approach in Multiple Sclerosis Rehabilitation: A Pilot Study

ERIC Educational Resources Information Center

Khan, Fary

2010-01-01

The objective of this study was to explore methods examining patient complexity and therapy interventions in relation to functional outcomes from an inpatient multiple sclerosis (MS) rehabilitation program. Retrospective and prospective data for 24 consecutive inpatients at a tertiary rehabilitation facility assessed (i)…

L-arginine plus drospirenone-ethinyl estradiol in the treatment of patients with PCOS: a prospective, placebo controlled, randomised, pilot study.

PubMed

Battaglia, Cesare; Mancini, Fulvia; Battaglia, Bruno; Facchinetti, Fabio; Artini, Paolo G; Venturoli, Stefano

2010-12-01

To verify the effects of a pill containing drospirenone on the surrogate markers of arterial function and to evaluate the possible improvements induced by the addition of L-arginine. A prospective, placebo controlled, randomised, pilot study. University of Bologna. Twenty-eight young women with PCOS. Random submission to: drospirenone + ethinylestradiol+ a placebo (Group I; n = 15) or drospirenone + ethinylestradiol + oral L-arginine (4 g × 2/daily) (Group II, n = 13). Medical examination; blood measurement of nitrites/nitrates, biochemical and hormonal parameters; ultrasonographic analysis and colour Doppler evaluation of uterine, stromal ovarian and ophthalmic arteries; analysis of brachial artery flow-mediated vasodilatation; and 24-h ambulatory blood pressure monitoring. The above parameters were evaluated before and after 6 months. The low dose oral contraceptive containing drospirenone favoured a pre-hypertensive state. The L-arginine supplementation increased the circulating levels of nitrites/nitrates and improved the endothelium-dependent vasodilatation counteracting the negative effect of the contraceptive pill. Although, the present pilot study was conducted in a limited number of patients, it seems that the L-arginine co-treatment may improve the long-term side effects of the pill reducing the risk of cardiovascular diseases.

Orthopedic Surgery and Post-Operative Cognitive Decline in Idiopathic Parkinson’s Disease: Considerations from a Pilot Study

PubMed Central

Price, Catherine C.; Levy, Shellie-Anne; Tanner, Jared; Garvan, Cyndi; Ward, Jade; Akbar, Farheen; Bowers, Dawn; Rice, Mark; Okun, Michael

2016-01-01

BACKGROUND Post-operative cognitive dysfunction (POCD) demarks cognitive decline after major surgery but has been studied to date in “healthy” adults. Although individuals with neurodegenerative disorders such as Parkinson’s disease (PD) commonly undergo elective surgery, these individuals have yet to be prospectively followed despite hypotheses of increased POCD risk. OBJECTIVE To conduct a pilot study examining cognitive change pre-post elective orthopedic surgery for PD relative to surgery and non-surgery peers. METHODS A prospective one-year longitudinal design. No-dementia idiopathic PD individuals were actively recruited along with non-PD “healthy” controls (HC) undergoing knee replacement surgery. Non-surgical PD and HC controls were also recruited. Attention/processing speed, inhibitory function, memory recall, animal (semantic) fluency, and motor speed were assessed at baseline (pre-surgery), three-weeks, three-months, and one-year post- orthopedic surgery. Reliable change methods examined individual changes for PD individuals relative to control surgery and control non-surgery peers. RESULTS Over two years we screened 152 older adult surgery or non-surgery candidates with 19 of these individuals having a diagnosis of PD. Final participants included 8 PD (5 surgery, 3 non-surgery), 47 Control Surgery, and 21 Control Non-Surgery. Eighty percent (4 of the 5) PD surgery declined greater than 1.645 standard deviations from their baseline performance on measures assessing processing speed and inhibitory function. This was not observed for the non-surgery PD individuals. CONCLUSION This prospective pilot study demonstrated rationale and feasibility for examining cognitive decline in at-risk neurodegenerative populations. We discuss recruitment and design challenges for examining post-operative cognitive decline in neurodegenerative samples. PMID:26683785

Oligofructose promotes satiety in healthy human: a pilot study.

PubMed

Cani, P D; Joly, E; Horsmans, Y; Delzenne, N M

2006-05-01

The administration of a fermentable dietary fibre (oligofructose) in rats increases satietogenic gut peptides and lowered spontaneous energy intake. The aim of the study was to assess the relevance of those effects of oligofructose on satiety and energy intake in humans. Single-blinded, crossover, placebo-controlled design, pilot study. Volunteers included five men and five women aged 21-39 years, BMI ranging from 18.5 to 27.4 kg/m(2), were randomly assigned as described below. Subjects were included in two 2-week experimental phases during which they received either fibre (oligofructose (OFS)) or placebo (dextrine maltose (DM)); a 2-week washout period was included between crossover phases. In total, 8 g OFS or 8 g DM were ingested twice daily (16 g/day in total). Energy intake, hunger, satiety, fullness and prospective food consumption were assessed with analogue scales at the end of each experimental phase. During breakfast, OFS significantly increases the satiety (P=0.04) without any difference on other sensations as compared to DM treatment periods. After lunch, no significant differences are observed between treatment period. At dinner, OFS significantly increases satiety (P=0.04), reduces hunger (P=0.04) and prospective food consumption (P=0.05). The energy intake at breakfast and lunch are significantly lower (P=0.01, 0.03, respectively) after OFS treatment than after DM treatment. Total energy intake per day is 5% lower during OFS than in DM period. Oligofructose treatment increases satiety following breakfast and dinner, reduces hunger and prospective food consumption following dinner. This pilot study presents a rationale to propose oligofructose supplements in the management of food intake in overweight and obese patients.

The role of mitomycin C in surgery of the frontonasal recess: a prospective open pilot study.

PubMed

Amonoo-Kuofi, Kwame; Lund, Valerie J; Andrews, Peter; Howard, David J

2006-01-01

Mitomycin C (MMC) inhibits fibroblast proliferation. The objective of this study was to determine the efficacy of MMC in reducing frontal ostium stenosis after endoscopic sinus surgery. A prospective open pilot study was conducted in 28 patients who had undergone one or more previous surgical interventions for frontal sinusitis. MMC solution was applied to the frontal ostial region via an endoscopic or combined endoscopic and external approach. Patency of the frontal ostium was evaluated endoscopically during regular follow-up. If restenosis was observed further, endoscopic application of MMC was undertaken. There were 17 men and 11 women (mean age, 51.7 years; range, 26-86 years). Mean number of applications was 1.5 (range, 1:3). Mean follow-up was 19 months (range, 6-32 months). Patency rate was 86%. Mitomycin appears to have an important role in reducing postoperative scarring, which may obviate the need for repeated and more extensive surgery.

Use of a Data-Linked Weather Information Display and Effects on Pilot Navigation Decision Making in a Piloted Simulation Study

NASA Technical Reports Server (NTRS)

Yuchnovicz, Daniel E.; Novacek, Paul F.; Burgess, Malcolm A.; Heck, Michael L.; Stokes, Alan F.

2001-01-01

This study provides recommendations to the FAA and to prospective manufacturers based on an exploration of the effects of data link weather displays upon pilot decision performance. An experiment was conducted with twenty-four current instrument rated pilots who were divided into two equal groups and presented with a challenging but realistic flight scenario involving weather containing significant embedded convective activity. All flights were flown in a full-mission simulation facility within instrument meteorological conditions. The inflight weather display depicted NexRad images, graphical METARs and textual METARs. The objective was to investigate the potential for misuse of a weather display, and incorporate recommendations for the design and use of these displays. The primary conclusion of the study found that the inflight weather display did not improve weather avoidance decision making. Some of the reasons to support this finding include: the pilot's inability to easily perceive their proximity to the storms, increased workload and difficulty in deciphering METAR textual data. The compelling nature of a graphical weather display caused many pilots to reduce their reliance on corroborating weather information from other sources. Minor changes to the weather display could improve the ability of a pilot to make better decisions on hazard avoidance.

Treatment of Neurogenic Cough with Tramadol: A Pilot Study.

PubMed

Dion, Gregory R; Teng, Stephanie E; Achlatis, Efstratios; Fang, Yixin; Amin, Milan R

2017-07-01

This study employs validated cough assessment tools to prospectively determine the impact of tramadol on cough severity and quality of life in subjects with neurogenic cough. The study was a prospective case series with planned data collection at a tertiary care academic medical center laryngology practice. Sixteen consecutive collected subjects with neurogenic cough prospectively completed pre- and posttreatment validated cough assessment tools, the cough severity index (CSI) and Leicester Cough Questionnaire (LCQ). All subjects in the study reported at least some improvement in their cough symptoms. In a Wilcoxon signed rank test that compared paired results, CSI scores improved from 23 to 14 and LCQ scores improved from 74 to 103 ( P = .003 and P = .005, respectively). This small preliminary assessment suggests that tramadol warrants additional evaluation as a treatment for neurogenic cough.

Career Repertoires of IT Students: A Group Counselling Case Study in Higher Education

ERIC Educational Resources Information Center

Penttinen, Leena; Vesisenaho, Mikko

2013-01-01

Uncertainty about future career prospects has increased enormously for students enrolled in higher education Information Technology (IT) programs. However, many computer science programmes pay little attention to career counselling. This article reports the results of a pilot study intended to develop group counselling for IT students to promote…

To Commit or Not to Commit: The Psychiatry Resident as a Variable in Involuntary Commitment Decisions

ERIC Educational Resources Information Center

Sattar, S. Pirzada; Pinals, Debra A.; Din, Amad U.; Appelbaum, Paul S.

2006-01-01

Objective: To study whether psychiatry residents' personal variables (such as age, gender, level of training, previous experience with patient suicide, or lawsuits) and their temperamental predispositions have an impact on their decisions to seek involuntary commitment. Method: In a prospective pilot study, all psychiatry residents in…

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

PubMed Central

Stroustrup, Annemarie; Plafkin, Callie

2016-01-01

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

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

PubMed

Stroustrup, A; Plafkin, C

2016-05-01

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

Ashtanga yoga for children and adolescents for weight management and psychological well being: an uncontrolled open pilot study.

PubMed

Benavides, Sandra; Caballero, Joshua

2009-05-01

The objective of this pilot study was to determine the effect of yoga on weight in youth at risk for developing type 2 diabetes. Secondarily, the impact of participation in yoga on self-concept and psychiatric symptoms was measured. A 12-week prospective pilot Ashtanga yoga program enrolled twenty children and adolescents. Weight was measured before and after the program. All participants completed self-concept, anxiety, and depression inventories at the initiation and completion of the program. Fourteen predominately Hispanic children, ages 8-15, completed the program. The average weight loss was 2kg. Weight decreased from 61.2+/-20.2kg to 59.2+/-19.2kg (p=0.01). Four of five children with low self-esteem improved, although two had decreases in self-esteem. Anxiety symptoms improved in the study. Ashtanga yoga may be beneficial as a weight loss strategy in a predominately Hispanic population.

75 FR 30908 - Notice of Funds Availability for FY 2010

Federal Register 2010, 2011, 2012, 2013, 2014

2010-06-02

... for the FY 2010 funding round of the Financial Education and Counseling (FEC) Pilot Program... Counseling Services to Prospective Homebuyers. The goals of grants that are awarded through the FEC Pilot Program are to identify successful methods of Financial Education and Counseling Services that result in...

Prospective pilot trial of PerMIT versus standard anticoagulation service management of patients initiating oral anticoagulation.

PubMed

Borgman, Mark P; Pendleton, Robert C; McMillin, Gwendolyn A; Reynolds, Kristen K; Vazquez, Sara; Freeman, Andrew; Wilson, Andrew; Valdes, Roland; Linder, Mark W

2012-09-01

We performed a randomised pilot trial of PerMIT, a novel decision support tool for genotype-based warfarin initiation and maintenance dosing, to assess its efficacy for improving warfarin management. We prospectively studied 26 subjects to compare PerMIT-guided management with routine anticoagulation service management. CYP2C9 and VKORC1 genotype results for 13 subjects randomly assigned to the PerMIT arm were recorded within 24 hours of enrolment. To aid in INR interpretation, PerMIT calculates estimated loading and maintenance doses based on a patient's genetic and clinical characteristics and displays calculated S-warfarin plasma concentrations based on planned or administered dosages. In comparison to control subjects, patients in the PerMIT study arm demonstrated a 3.6-day decrease in the time to reach a stabilised INR within the target therapeutic range (4.7 vs. 8.3 days, p = 0.015); a 12.8% increase in time spent within the therapeutic interval over the first 25 days of therapy (64.3% vs. 55.3%, p = 0.180); and a 32.9% decrease in the frequency of warfarin dose adjustments per INR measurement (38.3% vs. 57.1%, p = 0.007). Serial measurements of plasma S-warfarin concentrations were also obtained to prospectively evaluate the accuracy of the pharmacokinetic model during induction therapy. The PerMIT S-warfarin plasma concentration model estimated 62.8% of concentrations within 0.15 mg/l. These pilot data suggest that the PerMIT method and its incorporation of genotype/phenotype information may help practitioners increase the safety, efficacy, and efficiency of warfarin therapeutic management.

Prospective trial of an herbal formula BYSH and Saw palmetto in patients with hormonal refractory prostate cancer: a pilot study.

PubMed

Ng, Anthony C-F; Cheng, K-F; Leung, P-C

2014-01-01

BYSH, a herbal formula, was evaluated for efficacy and safety in a pilot study for patients with advanced hormone refractory prostate cancer (HRPC). The pilot study was designed as a single-center open-label trial. Patients with HRPC were treated with BYSH for 24 weeks. The primary end point was the changes in serum prostate-specific antigen (PSA) level. Safety parameters such as liver and renal functions were monitored during the study period. Ten patients were eligible for the study. Most of them had stable PSA levels while taking BYSH. However, at the end of the BYSH treatment, the level of PSA increased. The median survival from diagnosis of HRPC was 16.4 months. Liver and renal functions remained normal. BYSH was well tolerated and no patient reported adverse events during the study period. Although it is inappropriate to make a conclusion based on the pilot study results, the trend of improvement is obvious. Further investigations should be conducted to demonstrate its clinical benefits. We have also briefly reviewed some plant products which are patented and also available in market.

Smoking Cessation Delivered by Medical Students Is Helpful to Homeless Population

ERIC Educational Resources Information Center

Spector, Andrew; Alpert, Hilary; Karam-Hage, Maher

2007-01-01

Objective: The authors pilot a smoking-cessation outreach for the homeless that extends medical students' tobacco cessation education. Method: In this prospective study, second-year medical students administered cognitive behavior therapy or unstructured support to homeless subjects to help them quit smoking. Self-report and biological measures…

The Utility of Pitch Elevation in the Evaluation of Oropharyngeal Dysphagia: Preliminary Findings

ERIC Educational Resources Information Center

Malandraki, Georgia A.; Hind, Jacqueline A.; Gangnon, Ronald; Logemann, Jeri A.; Robbins, JoAnne

2011-01-01

Purpose: To evaluate the utility of a pitch elevation task in the assessment of oropharyngeal dysphagia. Method: This study was a pilot prospective cohort study including 40 consecutive patients (16 male and 24 female) who were referred by their physician for a swallowing evaluation. Patients were evaluated with a noninstrumental clinical…

Lacosamide for uncontrolled primary generalized tonic-clonic seizures: An open-label pilot study with 59-week extension.

PubMed

Wechsler, Robert T; Yates, Stephen L; Messenheimer, John; Leroy, Robert; Beller, Cynthia; Doty, Pamela

2017-02-01

Assess the safety of adjunctive lacosamide for the treatment of uncontrolled primary generalized tonic-clonic seizures in patients (16-65 years) with primary generalized (genetic) epilepsy (PGE). An open-label pilot safety study (SP0961; NCT01118949), comprising 12 weeks' historical baseline, 4 weeks' prospective baseline, 3 weeks' titration (target: 400mg/day adjunctive lacosamide) and 6 weeks' maintenance. Patients who continued to the extension study (SP0962; NCT01118962) then received ≤59 weeks of flexible treatment (100-800mg/day lacosamide with flexible dosing of concomitant antiepileptic drugs). The primary outcomes for SP0961 were the mean change (±standard deviation) in absence seizure or myoclonic seizure days per 28days from prospective baseline to maintenance; for SP0962, the incidence of treatment-emergent adverse events (TEAEs) and withdrawals because of TEAEs. Of the 49 patients who enrolled, 40 (82%) completed the pilot study and 9 discontinued (5 because of adverse events). Of the 39 patients who continued to the extension study, 10 discontinued (2 owing to TEAEs) and 29 (74%) completed the study. During the pilot study, patients reported a reduction in mean (±standard deviation) absence and myoclonic seizure days per 28days (-0.37±4.80, -2.19±5.80). Reductions were also observed during the extension study (-2.38±5.54, -2.78±6.43). Five patients in SP0961 and 2 patients in SP0962 experienced TEAEs of new or increased frequency of absence seizures or myoclonic seizures. The most common TEAEs during SP0961 were dizziness (39%) and nausea (27%), and during SP0962 were dizziness (26%) and upper respiratory tract infection (26%). The safety profile of adjunctive lacosamide was similar to that previously published. Adjunctive lacosamide did not systematically worsen absence or myoclonic seizures, and appears to be well tolerated in patients with PGE. Copyright © 2016. Published by Elsevier B.V.

The clinical outcome and microbiological profile of bone-anchored hearing systems (BAHS) with different abutment topographies: a prospective pilot study.

PubMed

Trobos, Margarita; Johansson, Martin Lars; Jonhede, Sofia; Peters, Hanna; Hoffman, Maria; Omar, Omar; Thomsen, Peter; Hultcrantz, Malou

2018-06-01

In this prospective clinical pilot study, abutments with different topologies (machined versus polished) were compared with respect to the clinical outcome and the microbiological profile. Furthermore, three different sampling methods (retrieval of abutment, collection of peri-abutment exudate using paper-points, and a small peri-abutment soft-tissue biopsy) were evaluated for the identification and quantification of colonising bacteria. Twelve patients, seven with machined abutment and five with polished abutment, were included in the analysis. Three different sampling procedures were employed for the identification and quantification of colonising bacteria from baseline up to 12 months, using quantitative culturing. Clinical outcome measures (Holgers score, hygiene, pain, numbness and implant stability) were investigated. The clinical parameters, and total viable bacteria per abutment or in tissue biopsies did not differ significantly between the polished and machined abutments. The total CFU/mm 2 abutment and CFU/peri-abutment fluid space of anaerobes, aerobes and staphylococci were significantly higher for the polished abutment. Anaerobic bacteria were detected in the tissue biopsies before BAHS implantation. Anaerobes and Staphylococcus spp. were detected in all three compartments after BAHS installation. For most patients (10/12), the same staphylococcal species were found in at least two of the three compartments at the same time-point. The common skin coloniser Staphylococcus epidermidis was identified in all patients but one (11/12), whereas the pathogen Staphylococcus aureus was isolated in five of the patients. Several associations between clinical and microbiological parameters were found. There was no difference in the clinical outcome with the use of polished versus machined abutment at 3 and 12 months after implantation. The present pilot trial largely confirmed a suitable study design, sampling and analytical methodology to determine the effects of modified BAHS abutment properties. 2. Controlled prospective comparative study.

Validity and reliability of a pilot scale for assessment of multiple system atrophy symptoms.

PubMed

Matsushima, Masaaki; Yabe, Ichiro; Takahashi, Ikuko; Hirotani, Makoto; Kano, Takahiro; Horiuchi, Kazuhiro; Houzen, Hideki; Sasaki, Hidenao

2017-01-01

Multiple system atrophy (MSA) is a rare progressive neurodegenerative disorder for which brief yet sensitive scale is required in order for use in clinical trials and general screening. We previously compared several scales for the assessment of MSA symptoms and devised an eight-item pilot scale with large standardized response mean [handwriting, finger taps, transfers, standing with feet together, turning trunk, turning 360°, gait, body sway]. The aim of the present study is to investigate the validity and reliability of a simple pilot scale for assessment of multiple system atrophy symptoms. Thirty-two patients with MSA (15 male/17 female; 20 cerebellar subtype [MSA-C]/12 parkinsonian subtype [MSA-P]) were prospectively registered between January 1, 2014 and February 28, 2015. Patients were evaluated by two independent raters using the Unified MSA Rating Scale (UMSARS), Scale for Assessment and Rating of Ataxia (SARA), and the pilot scale. Correlations between UMSARS, SARA, pilot scale scores, intraclass correlation coefficients (ICCs), and Cronbach's alpha coefficients were calculated. Pilot scale scores significantly correlated with scores for UMSARS Parts I, II, and IV as well as with SARA scores. Intra-rater and inter-rater ICCs and Cronbach's alpha coefficients remained high (> 0.94) for all measures. The results of the present study indicate the validity and reliability of the eight-item pilot scale, particularly for the assessment of symptoms in patients with early state multiple system atrophy.

Correlation of serum MMP3 and other biomarkers with clinical outcomes in patients with ankylosing spondylitis: A pilot study

USDA-ARS?s Scientific Manuscript database

The studies aimed to assess a set of biomarkers for their correlations with disease activity/severity of patients with ankylosing spondylitis (AS). A total of 24 AS patients were treated with etanercept and prospectively followed for 12 weeks. Serum levels of TNF-alpha, IFN-gamma, TGF-beta, IL6, IL1...

Calcium Nutrition Perceptions among Food Bank Users: A Canadian Case Study

ERIC Educational Resources Information Center

Johnson, Shanthi; Hawkins, Nicki

2010-01-01

The present study examined the differences in the food bank users' perceptions related to calcium nutrition across sex and employment status using a cross-sectional, prospective design at a large food bank in Canada. A total of 197 individuals participated for a response rate of 97%. A structured survey was developed and pilot tested before it was…

Dietary Status and Impact of Risperidone on Nutritional Balance in Children with Autism: A Pilot Study

ERIC Educational Resources Information Center

Lindsay, Ronald L.; Arnold, L. Eugene; Aman, Michael G.; Vitiello, Benedetto; Posey, David J.; McDougle, Christopher J.; Scahill, Lawrence; Pachler, Maryellen; McCracken, James T.; Tierney, Elaine; Bozzolo, Dawn

2006-01-01

Background: Risperidone may be effective in improving tantrums, aggression, or self-injurious behaviour in children with autism, but often leads to weight gain. Method: Using a quantitative Food Frequency Questionnaire (FFQ), we prospectively examined the nutritional intake of 20 children with autism participating in a randomised…

The effect of polycarbophil gel (Replens) on bacterial vaginosis: a pilot study.

PubMed

Wu, Justine P; Fielding, Stephen L; Fiscella, Kevin

2007-01-01

To determine if use of intravaginal polycarbophil gel (Replens) for 1 month will: (1) lower vaginal pH; (2) improve signs of bacterial vaginosis (BV). Seventeen women with BV self-administered polycarbophil gel every third day for 4 weeks in an open-label, prospective pilot study. Primary outcome measures included vaginal pH, presence of amines and Nugent scores. At week 4, there was improvement in Nugent scores, vaginal odor and clue cell count (p<0.05). Eleven women converted from amine positive to negative (73+/-20%). There was no significant change in vaginal pH. Polycarbophil gel is associated with improved signs of BV, although not vaginal pH.

Statistical analysis plan of the head position in acute ischemic stroke trial pilot (HEADPOST pilot).

PubMed

Olavarría, Verónica V; Arima, Hisatomi; Anderson, Craig S; Brunser, Alejandro; Muñoz-Venturelli, Paula; Billot, Laurent; Lavados, Pablo M

2017-02-01

Background The HEADPOST Pilot is a proof-of-concept, open, prospective, multicenter, international, cluster randomized, phase IIb controlled trial, with masked outcome assessment. The trial will test if lying flat head position initiated in patients within 12 h of onset of acute ischemic stroke involving the anterior circulation increases cerebral blood flow in the middle cerebral arteries, as measured by transcranial Doppler. The study will also assess the safety and feasibility of patients lying flat for ≥24 h. The trial was conducted in centers in three countries, with ability to perform early transcranial Doppler. A feature of this trial was that patients were randomized to a certain position according to the month of admission to hospital. Objective To outline in detail the predetermined statistical analysis plan for HEADPOST Pilot study. Methods All data collected by participating researchers will be reviewed and formally assessed. Information pertaining to the baseline characteristics of patients, their process of care, and the delivery of treatments will be classified, and for each item, appropriate descriptive statistical analyses are planned with comparisons made between randomized groups. For the outcomes, statistical comparisons to be made between groups are planned and described. Results This statistical analysis plan was developed for the analysis of the results of the HEADPOST Pilot study to be transparent, available, verifiable, and predetermined before data lock. Conclusions We have developed a statistical analysis plan for the HEADPOST Pilot study which is to be followed to avoid analysis bias arising from prior knowledge of the study findings. Trial registration The study is registered under HEADPOST-Pilot, ClinicalTrials.gov Identifier NCT01706094.

Social motivation in prospective memory: higher importance ratings and reported performance rates for social tasks.

PubMed

Penningroth, Suzanna L; Scott, Walter D; Freuen, Margaret

2011-03-01

Few studies have addressed social motivation in prospective memory (PM). In a pilot study and two main studies, we examined whether social PM tasks possess a motivational advantage over nonsocial PM tasks. In the pilot study and Study 1, participants listed their real-life important and less important PM tasks. Independent raters categorized the PM tasks as social or nonsocial. Results from both studies showed a higher proportion of tasks rated as social when important tasks were requested than when less important tasks were requested. In Study 1, participants also reported whether they had remembered to perform each PM task. Reported performance rates were higher for tasks rated as social than for those rated as nonsocial. Finally, in Study 2, participants rated the importance of two hypothetical PM tasks, one social and one nonsocial. The social PM task was rated higher in importance. Overall, these findings suggest that social PM tasks are viewed as more important than nonsocial PM tasks and they are more likely to be performed. We propose that consideration of the social relevance of PM will lead to a more complete and ecologically valid theoretical description of PM performance. (PsycINFO Database Record (c) 2011 APA, all rights reserved).

Prospective, pilot evaluation of the performance of nanofractional radiofrequency for improvement of skin texture via skin resurfacing.

PubMed

Bohnert, Krista; Dorizas, Andrew; Sadick, Neil

2018-02-01

The latest generation of radiofrequency, nanofractional radiofrequency, allows the heat energy to be delivered through the use of pins or needles as electrodes, facilitating increased efficacy and reduced pain, downtime, and side effects. The objective of this prospective pilot clinical study was to evaluate the efficacy of nanofractional radiofrequency in skin resurfacing. Seventeen subjects were enrolled in the study, and each received three nanofractional radiofrequency (160-pin tip) treatments in the facial area at 3-week intervals. Follow-up visits were scheduled at 1 and 2 months after the final treatment. Clinical photography, patient, and investigator assessments were conducted during the treatment visits and follow-up. All subjects completed the study. At the 1- and 2-month follow-up, there was a moderate to significant improvement (2.6 and 3.5, respectively, P = .01) according to the investigator global esthetic improvement scale rating. Most subjects reported that they were satisfied or very satisfied with the outcome and level of comfort. Nanofractional radiofrequency is a safe and effective strategy for improving texture, tone, and skin laxity with high patient satisfaction and tolerable safety profile. © 2017 Wiley Periodicals, Inc.

Premature Discontinuation of Prospective Clinical Studies Approved by a Research Ethics Committee - A Comparison of Randomised and Non-Randomised Studies.

PubMed

Blümle, Anette; Schandelmaier, Stefan; Oeller, Patrick; Kasenda, Benjamin; Briel, Matthias; von Elm, Erik

2016-01-01

Premature discontinuation of clinical studies affects about 25% of randomised controlled trials (RCTs) which raises concerns about waste of scarce resources for research. The risk of discontinuation of non-randomised prospective studies (NPSs) is yet unclear. To compare the proportion of discontinued studies between NPSs and RCTs that received ethical approval. We systematically surveyed prospective longitudinal clinical studies that were approved by a single REC in Freiburg, Germany between 2000 and 2002. We collected study characteristics, identified subsequent publications, and surveyed investigators to elucidate whether a study was discontinued and, if so, why. Of 917 approved studies, 547 were prospective longitudinal studies (306 RCTs and 241 NPSs). NPSs were on average smaller than RCTs, more frequently single centre and pilot studies, and less frequently funded by industry. NPSs were less frequently discontinued than RCTs: 32/221 (14%) versus 78/288 (27%, p<0.001, missing data excluded). Poor recruitment was the most frequent reason for discontinuation in both NPSs (36%) and RCTs (37%). Compared to RCTs, NPSs were at lower risk for discontinuation. Measures to reliably predict, sustain, and stimulate recruitment could prevent discontinuation of many RCTs but also of some NPSs.

Fluoxetine for vestibular dysfunction and anxiety: a prospective pilot study.

PubMed

Simon, Naomi M; Parker, Stephen W; Wernick-Robinson, Mara; Oppenheimer, Julia E; Hoge, Elizabeth A; Worthington, John J; Korbly, Nicole B; Pollack, Mark H

2005-01-01

Anxiety states and disorders amplify the symptoms and impairment associated with vestibular dysfunction. Five patients with inner ear vestibular dysfunction and anxiety were prospectively treated with fluoxetine, 20-60 mg/day, and received an extensive battery of assessments at baseline and after 12 weeks of treatment. Fluoxetine led to significant or near significant reductions in anxiety measures and in impairment due to dizziness; improvements in clinical balance function and vestibular function were less clear. The data add to the literature suggesting a role for selective serotonin reuptake inhibitors in the treatment of dizziness and anxiety.

Pilot study of enhanced tobacco-cessation services coverage for low-income smokers.

PubMed

Doescher, Mark P; Whinston, Melicent A; Goo, Alvin; Cummings, Diane; Huntington, Jane; Saver, Barry G

2002-01-01

This study explored the feasibility of covering nicotine replacement therapy (NRT) and paying for pharmacist-delivered smoking cessation counseling at the time of NRT pick-up for low-income, managed Medicaid and Basic Health Plan (a state insurance program) enrollees. A prospective pilot intervention was used at two community health centers (CHCs) and two community pharmacies. Participants were adult managed-Medicaid or Basic Health Plan enrollees who attended the pilot CHCs and smoked. An innovative insurance benefit that included coverage for NRT and $15 payment to the pharmacist to deliver cessation counseling with each prescription fill. Proportion of eligible patients who used the cessation benefit and patient and pharmacist satisfaction with the intervention. During the 9-month intervention, 32 patients at the pilot clinics were referred for NRT and pharmacist-delivered counseling. This number represented roughly 5% of eligible smokers. Of these, 26 received NRT with concomitant pharmacist-delivered cessation counseling at least once. Recipients reported a high level of satisfaction with this intervention. Pharmacists indicated they would continue providing counseling if reimbursement remained adequate and if counseling lasted no longer than 5-10 min. However, 12 (38%) who were referred were no longer insured by the sponsoring plan by the end of the 9-month pilot period. Pharmacist-delivered cessation counseling may be feasible and merits further study. More importantly, this pilot reveals two key obstacles in our low-income, culturally diverse setting: low participation and rapid turnover of insureds. Future interventions will need to address these barriers.

Treatment of Lymphedema with Saam Acupuncture in Patients with Breast Cancer: A Pilot Study

PubMed Central

Jeong, Young Ju; Kwon, Hyo Jung; Park, Young Sun; Kwon, Oh Chang; Shin, Im Hee

2015-01-01

Abstract Background: Lymphedema is a troublesome complication affecting quality of life (QoL) in many women after breast-cancer treatment. Recent studies have suggested that acupuncture can reduce symptoms of lymphedema in breast-cancer survivors. Objectives: This was a pilot study. It was designed to assess the feasibility and the safety of acupuncture with the Saam acupuncture method for treating lymphedema in Korean patients after surgical therapy for breast cancer. Materials and Methods: This was a prospective, single-arm, observational pilot study using before and after measurements. The study was conducted at the East-West Medical Center at the Daegu Catholic University Medical Center, in Daegu, Korea. The subjects were 9 patients with breast cancer who presented with lymphedema of the upper limb ipsilateral to surgery. Saam acupuncture was administered 3 times per week for 6 consecutive weeks, for 30±5 minutes at each session.The primary outcome measure was severity of lymphedema as assessed by stages of lymphedema, a visual analogue scale (VAS), and by circumferential measurements of the upper extremity. The secondary outcome measure was QoL, which was assessed by a self-administered questionnaire using the Short Form–36 questionnaire. Results: Acupuncture reduced severity of lymphedema significantly, as assessed by the VAS (P<0.001) as well as by circumferential measurements of the upper extremity. Four weeks after the final treatment, symptoms were not aggravated. SF-36 scores remained significant for health status at the end of treatment. Conclusions: The Saam acupuncture method appeared to provide reduction of lymphedema among women after they had undergone surgery for breast cancer. A randomized, controlled prospective study with a larger sample size is required to clarify the role of acupuncture for managing lymphedema in patients with breast cancer. PMID:26155321

Remotely piloted aircraft in the civil environment

NASA Technical Reports Server (NTRS)

Gregory, T. J.; Nelms, W. P.; Karmarkar, J. S.

1977-01-01

Remotely piloted aircraft (RPA's) are of increasing interest to the military and others, as evidenced by a number of technology and development programs that are currently funded or planned. These programs have led to a number of test aircraft with significant capabilities, and future remotely piloted aircraft are forecast to become even more capable as the technology in a number of important subsystem areas is progressing at a rapid rate. As the size, weight and cost of RPA's is reduced, the prospect of using them for civilian applications becomes more likely.

How to treat two adjacent missing teeth with dental implants. A systematic review on single implant-supported two-unit cantilever FDP's and results of a 5-year prospective comparative study in the aesthetic zone.

PubMed

Van Nimwegen, W G; Raghoebar, G M; Tymstra, N; Vissink, A; Meijer, H J A

2017-06-01

To conduct a systematic review on the clinical outcome of single implant-supported two-unit cantilever FDP's and to conduct a 5-year prospective comparative pilot study of patients with a missing central and lateral upper incisor treated with either a single implant-supported two-unit cantilever FDP or two implants with solitary implant crowns in the aesthetic zone. Medline, Embase and the Cochrane Central Register of Controlled Trials were searched (last search 1 August 2016) for eligible studies. In the comparative pilot study, an implant-cantilever group of five patients with a single implant-supported two-unit cantilever FDP (NobelReplace Groovy Regular Platform) was compared with an implant-implant group of five patients with two adjacent single implant-supported crowns (NobelReplace Groovy Regular Platform) in the aesthetic zone. Implant survival, marginal bone level (MBL) changes, pocket probing depth, papilla index and patient satisfaction were assessed during a 5-year follow-up period. Five of 276 articles were considered eligible for data extraction. Implant survival ranged from 96·6% to 100%. Marginal bone level changes were higher in the anterior region than in the posterior region. Technical complications occurred more often in the posterior than anterior region. In the 5-year comparative pilot study, no clinically significant differences in hard and soft peri-implant tissue levels occurred between both groups. Single implant-supported two-unit cantilever FDP's can be a viable alternative to the placement of two adjacent single implant crowns in the aesthetic zone. Due to technical complications, placement of two-unit cantilever crowns in the posterior region can be considered unwise. © 2017 John Wiley & Sons Ltd.

High Dose Vitamin D Therapy for Chronic Pain in Children and Adolescents with Sickle Cell Disease: Results of a Randomized Double Blind Pilot Study

PubMed Central

I, Osunkwo; TR, Ziegler; J, Alvarez; C, McCracken; K, Cherry; CE, Osunkwo; SF, Ofori-Acquah; S, Ghosh; A, Ogunbobode; J, Rhodes; JR, Eckman; CD, Dampier; V, Tangpricha

2012-01-01

Summary We report results of a pilot study of high-dose vitamin D in sickle cell disease (SCD). Subjects were followed for 6 months after receiving a six-week course of oral high-dose cholecalciferol or placebo. Vitamin D insufficiency and deficiency was present at baseline in 82.5% and 52.5% of subjects, respectively. Subjects who received high-dose vitamin D achieved higher serum 25-hydroxyvitamin D, experienced fewer pain days per week, and had higher physical activity quality-of-life scores. These findings suggest a potential benefit of vitamin D in reducing the number of pain days in SCD. Larger prospective studies with longer duration are needed to confirm these effects. PMID:22924607

Effect of pregnancy on the pharmacokinetics of paclitaxel: a case report.

PubMed

Lycette, Jennifer L; Dul, Carrie L; Munar, Myrna; Belle, Donna; Chui, Stephen Y; Koop, Dennis R; Nichols, Craig R

2006-10-01

Breast cancer during pregnancy is increasingly common as women delay childbearing until later in life. Safe administration of adjuvant chemotherapy during pregnancy has been reported. Physiologic and metabolic changes during pregnancy could alter the pharmacokinetics of these agents. This is a pilot study to prospectively study the pharmacokinetics of chemotherapeutic agents during pregnancy. Herein, we report the initial results with paclitaxel in the first patient.

Medication reconciliation in pediatric cardiology performed by a pharmacy technician: a prospective cohort comparison study.

PubMed

Chan, Carol; Woo, Renée; Seto, Winnie; Pong, Sandra; Gilhooly, Tessie; Russell, Jennifer

2015-01-01

Medication reconciliation reduces potential medication discrepancies and adverse drug events. The role of pharmacy technicians in obtaining best possible medication histories (BPMHs) and performing reconciliation at the admission and transfer interfaces of care for pediatric patients has not been described. To compare the completeness and accuracy of BPMHs and reconciliation conducted by a pharmacy technician (pilot study) and by nurses and/or pharmacists (baseline). The severity of identified unintentional discrepancies was rated to determine their clinical importance. This prospective cohort comparison study involved patients up to 18 years of age admitted to and/or transferred between the Cardiology ward and the Cardiac Critical Care Unit of a pediatric tertiary care teaching hospital. A pharmacy resident conducted two 3-week audits: the first to assess the completeness and accuracy of BPMHs and reconciliation performed by nurses and/or pharmacists and the second to assess the completeness and accuracy of BPMHs and reconciliation performed by a pharmacy technician. The total number of patients was 38 in the baseline phase and 46 in the pilot period. There were no statistically significant differences between the baseline and pilot audits in terms of completion of BPMH (82% [28/34] versus 78% [21/27], p = 0.75) or completion of reconciliation (70% [23/33] versus 75% [15/20], p = 0.76) within 24 h of admission. Completeness of transfer reconciliation was significantly higher during the pilot study than at baseline (91% [31/34] versus 61% [11/18], p = 0.022). No significant differences between the baseline and pilot audits were found in the proportions of patients with at least one BPMH discrepancy (38% [13/34] versus 22% [6/27], p = 0.27), at least one unintentional discrepancy upon admission (21% [7/33] versus 10% [2/20], p = 0.46), or at least one unintentional discrepancy at the transfer interface (6% [1/18] versus 3% [1/34], p = 0.58). None of the 16 unintentional discrepancies were rated as causing severe patient discomfort or clinical deterioration. A trained pharmacy technician can perform admission and transfer medication reconciliation for pediatric patients with completeness and accuracy comparable to those of nurses and pharmacists. Future studies should explore the sustainability and cost-effectiveness of this practice model.

Medication Reconciliation in Pediatric Cardiology Performed by a Pharmacy Technician: A Prospective Cohort Comparison Study

PubMed Central

Chan, Carol; Woo, Renée; Seto, Winnie; Pong, Sandra; Gilhooly, Tessie; Russell, Jennifer

2015-01-01

Background: Medication reconciliation reduces potential medication discrepancies and adverse drug events. The role of pharmacy technicians in obtaining best possible medication histories (BPMHs) and performing reconciliation at the admission and transfer interfaces of care for pediatric patients has not been described. Objectives: To compare the completeness and accuracy of BPMHs and reconciliation conducted by a pharmacy technician (pilot study) and by nurses and/or pharmacists (baseline). The severity of identified unintentional discrepancies was rated to determine their clinical importance. Methods: This prospective cohort comparison study involved patients up to 18 years of age admitted to and/or transferred between the Cardiology ward and the Cardiac Critical Care Unit of a pediatric tertiary care teaching hospital. A pharmacy resident conducted two 3-week audits: the first to assess the completeness and accuracy of BPMHs and reconciliation performed by nurses and/or pharmacists and the second to assess the completeness and accuracy of BPMHs and reconciliation performed by a pharmacy technician. Results: The total number of patients was 38 in the baseline phase and 46 in the pilot period. There were no statistically significant differences between the baseline and pilot audits in terms of completion of BPMH (82% [28/34] versus 78% [21/27], p = 0.75) or completion of reconciliation (70% [23/33] versus 75% [15/20], p = 0.76) within 24 h of admission. Completeness of transfer reconciliation was significantly higher during the pilot study than at baseline (91% [31/34] versus 61% [11/18], p = 0.022). No significant differences between the baseline and pilot audits were found in the proportions of patients with at least one BPMH discrepancy (38% [13/34] versus 22% [6/27], p = 0.27), at least one unintentional discrepancy upon admission (21% [7/33] versus 10% [2/20], p = 0.46), or at least one unintentional discrepancy at the transfer interface (6% [1/18] versus 3% [1/34], p = 0.58). None of the 16 unintentional discrepancies were rated as causing severe patient discomfort or clinical deterioration. Conclusions: A trained pharmacy technician can perform admission and transfer medication reconciliation for pediatric patients with completeness and accuracy comparable to those of nurses and pharmacists. Future studies should explore the sustainability and cost-effectiveness of this practice model. PMID:25762814

The Emergence of the International Baccalaureate Diploma in Ontario: Diffusion, Pilot Study and Prospective Research

ERIC Educational Resources Information Center

Tarc, Paul; Beatty, Luke

2012-01-01

The International Baccalaureate Diploma Program (IBDP), created in the field of international schools in the late 1960s, has made considerable in-roads into publicly-funded schooling in many educational jurisdictions of the Anglo-West. Although the IBDP did not enter into the Ontario public system until 1991, there are now forty-four (and growing)…

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

PubMed

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

2012-01-01

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

Statistical aspects of quantitative real-time PCR experiment design.

PubMed

Kitchen, Robert R; Kubista, Mikael; Tichopad, Ales

2010-04-01

Experiments using quantitative real-time PCR to test hypotheses are limited by technical and biological variability; we seek to minimise sources of confounding variability through optimum use of biological and technical replicates. The quality of an experiment design is commonly assessed by calculating its prospective power. Such calculations rely on knowledge of the expected variances of the measurements of each group of samples and the magnitude of the treatment effect; the estimation of which is often uninformed and unreliable. Here we introduce a method that exploits a small pilot study to estimate the biological and technical variances in order to improve the design of a subsequent large experiment. We measure the variance contributions at several 'levels' of the experiment design and provide a means of using this information to predict both the total variance and the prospective power of the assay. A validation of the method is provided through a variance analysis of representative genes in several bovine tissue-types. We also discuss the effect of normalisation to a reference gene in terms of the measured variance components of the gene of interest. Finally, we describe a software implementation of these methods, powerNest, that gives the user the opportunity to input data from a pilot study and interactively modify the design of the assay. The software automatically calculates expected variances, statistical power, and optimal design of the larger experiment. powerNest enables the researcher to minimise the total confounding variance and maximise prospective power for a specified maximum cost for the large study. Copyright 2010 Elsevier Inc. All rights reserved.

Examining the effectiveness of an intensive, 2-week treatment program for military personnel and veterans with PTSD: Results of a pilot, open-label, prospective cohort trial.

PubMed

Bryan, Craig J; Leifker, Feea R; Rozek, David C; Bryan, AnnaBelle O; Reynolds, Mira L; Oakey, D Nicolas; Roberge, Erika

2018-06-19

This study aimed to examine the effectiveness of cognitive processing therapy (CPT) for posttraumatic stress disorder (PTSD) when administered on a daily basis during a 2-week period of time. In an open-label, prospective cohort pilot trial, 20 U.S. military personnel and veterans diagnosed with PTSD or subthreshold PTSD participated in 12 daily sessions of CPT. Primary outcomes included Clinician Administered PTSD Scale for DSM-5 and PTSD Checklist for DSM-5 scores. Secondary outcomes included Patient Health Questionnaire-8 and Beck Scale for Suicide Ideation (BSSI) scores. Interviews and self-report scales were completed at pretreatment, posttreatment, and 6 months after the treatment. Relative to baseline, PTSD symptom severity and rates of PTSD diagnosis were significantly reduced at posttreatment and 6-month follow-up. Depression symptom severity did not significantly improve, but suicide ideation significantly decreased at 6-month follow-up. Daily administration of CPT is associated with significant reductions in PTSD and suicide ideation. © 2018 Wiley Periodicals, Inc.

Prospective markets and design concepts for civilian remotely piloted aircraft

NASA Technical Reports Server (NTRS)

Nelms, W. P., Jr.; Gregory, T. J.; Aderhold, J. R.

1976-01-01

This paper summarizes a study that examines the technical, economic, and environmental aspects of remotely piloted vehicles (RPVs) in the civil environment. A market survey was conducted in which 35 civil applications of RPVs were identified. For a number of these uses, vehicle and system concepts were defined, benefit and cost comparisons were made with present methods, and the influence of safety and environmental implications was assessed. The results suggest a sizable potential demand for the use of RPVs in the civil sector, and some of the applications show promising cost savings over established methods. A focussed technology effort could provide the safety assurances needed for routine civilian operation of RPVs.

Piloted aircraft simulation concepts and overview

NASA Technical Reports Server (NTRS)

Sinacori, J. B.

1978-01-01

An overview of piloted aircraft simulation is presented that reflects the viewpoint of an aeronautical technologist. The intent is to acquaint potential users with some of the basic concepts and issues that characterize piloted simulation. Application to the development of aircraft are highlighted, but some aspects of training simulators are covered. A historical review is given together with a description of some current simulators. Simulator usages, advantages, and limitations are discussed and human perception qualities important to simulation are related. An assessment of current simulation is presented that addresses validity, fidelity, and deficiencies. Future prospects are discussed and technology projections are made.

Premature Discontinuation of Prospective Clinical Studies Approved by a Research Ethics Committee – A Comparison of Randomised and Non-Randomised Studies

PubMed Central

Oeller, Patrick; Kasenda, Benjamin; Briel, Matthias; von Elm, Erik

2016-01-01

Background Premature discontinuation of clinical studies affects about 25% of randomised controlled trials (RCTs) which raises concerns about waste of scarce resources for research. The risk of discontinuation of non-randomised prospective studies (NPSs) is yet unclear. Objectives To compare the proportion of discontinued studies between NPSs and RCTs that received ethical approval. Methods We systematically surveyed prospective longitudinal clinical studies that were approved by a single REC in Freiburg, Germany between 2000 and 2002. We collected study characteristics, identified subsequent publications, and surveyed investigators to elucidate whether a study was discontinued and, if so, why. Results Of 917 approved studies, 547 were prospective longitudinal studies (306 RCTs and 241 NPSs). NPSs were on average smaller than RCTs, more frequently single centre and pilot studies, and less frequently funded by industry. NPSs were less frequently discontinued than RCTs: 32/221 (14%) versus 78/288 (27%, p<0.001, missing data excluded). Poor recruitment was the most frequent reason for discontinuation in both NPSs (36%) and RCTs (37%). Conclusions Compared to RCTs, NPSs were at lower risk for discontinuation. Measures to reliably predict, sustain, and stimulate recruitment could prevent discontinuation of many RCTs but also of some NPSs. PMID:27792749

Second Community Pilot Project Programme: Transition of Young People from School to Adult and Working Life: Results and Prospects. Dossier.

ERIC Educational Resources Information Center

Eurydice News, 1987

1987-01-01

During 1983-87 the Commission of the European Communities helped fund 30 pilot projects that were intended to help young people aged 14-18 make the transition from school to work in 10 member states. The objective of these projects was to use local initiative to identify and develop innovative solutions to the problems facing young people. The…

Primary Immune Deficiency Treatment Consortium (PIDTC) report.

PubMed

Griffith, Linda M; Cowan, Morton J; Notarangelo, Luigi D; Kohn, Donald B; Puck, Jennifer M; Pai, Sung-Yun; Ballard, Barbara; Bauer, Sarah C; Bleesing, Jack J H; Boyle, Marcia; Brower, Amy; Buckley, Rebecca H; van der Burg, Mirjam; Burroughs, Lauri M; Candotti, Fabio; Cant, Andrew J; Chatila, Talal; Cunningham-Rundles, Charlotte; Dinauer, Mary C; Dvorak, Christopher C; Filipovich, Alexandra H; Fleisher, Thomas A; Bobby Gaspar, Hubert; Gungor, Tayfun; Haddad, Elie; Hovermale, Emily; Huang, Faith; Hurley, Alan; Hurley, Mary; Iyengar, Sumathi; Kang, Elizabeth M; Logan, Brent R; Long-Boyle, Janel R; Malech, Harry L; McGhee, Sean A; Modell, Fred; Modell, Vicki; Ochs, Hans D; O'Reilly, Richard J; Parkman, Robertson; Rawlings, David J; Routes, John M; Shearer, William T; Small, Trudy N; Smith, Heather; Sullivan, Kathleen E; Szabolcs, Paul; Thrasher, Adrian; Torgerson, Troy R; Veys, Paul; Weinberg, Kenneth; Zuniga-Pflucker, Juan Carlos

2014-02-01

The Primary Immune Deficiency Treatment Consortium (PIDTC) is a network of 33 centers in North America that study the treatment of rare and severe primary immunodeficiency diseases. Current protocols address the natural history of patients treated for severe combined immunodeficiency (SCID), Wiskott-Aldrich syndrome, and chronic granulomatous disease through retrospective, prospective, and cross-sectional studies. The PIDTC additionally seeks to encourage training of junior investigators, establish partnerships with European and other International colleagues, work with patient advocacy groups to promote community awareness, and conduct pilot demonstration projects. Future goals include the conduct of prospective treatment studies to determine optimal therapies for primary immunodeficiency diseases. To date, the PIDTC has funded 2 pilot projects: newborn screening for SCID in Navajo Native Americans and B-cell reconstitution in patients with SCID after hematopoietic stem cell transplantation. Ten junior investigators have received grant awards. The PIDTC Annual Scientific Workshop has brought together consortium members, outside speakers, patient advocacy groups, and young investigators and trainees to report progress of the protocols and discuss common interests and goals, including new scientific developments and future directions of clinical research. Here we report the progress of the PIDTC to date, highlights of the first 2 PIDTC workshops, and consideration of future consortium objectives. Published by Mosby, Inc.

Prospective Assessment of Neurocognition in Future Gulf-deployed and Gulf-nondeployed Military Personnel: A Pilot Study

DTIC Science & Technology

2007-02-01

increased emotional distress but with advantaged simple reactiontime. Unit cohesion buffers the adverse effects of early life events on PTSD prior to...motor speed), and emotional (e.g., mood) behaviors thought to reflect neural integrity. Unresolved issues include whether subjective...including neurobehavioral and emotional functioning, (b) examine the impact of deployment-related stress and environmental exposures on

Intranasal dexmedetomidine for sedation for pediatric computed tomography imaging.

PubMed

Mekitarian Filho, Eduardo; Robinson, Fay; de Carvalho, Werther Brunow; Gilio, Alfredo Elias; Mason, Keira P

2015-05-01

This prospective observational pilot study evaluated the aerosolized intranasal route for dexmedetomidine as a safe, effective, and efficient option for infant and pediatric sedation for computed tomography imaging. The mean time to sedation was 13.4 minutes, with excellent image quality, no failed sedations, or significant adverse events. Registered with ClinicalTrials.gov: NCT01900405. Copyright © 2015 Elsevier Inc. All rights reserved.

CHIP Utilization in South Texas: A Prospective Longitudinal Study of the Children's Health Insurance Program. JSRI Research Report No. 33

ERIC Educational Resources Information Center

Millard, Ann V.; Mier, Nelda; Gabriel, Olga; Flores, Soledad

2004-01-01

The Children's Health Insurance Program (CHIP) began as a federal stopgap measure to assist families whose incomes were too high to qualify for Medicaid, but too low to make health insurance for their children affordable. In 2002, efforts were launched around the United States to recruit eligible children into the program. This pilot study…

The effectiveness of Korean medicine treatment in male patients with infertility: a study protocol for a prospective observational pilot study.

PubMed

Kim, Kwan-Ii; Jo, Junyoung

2018-01-01

Male factor subfertility has increasingly been considered the cause of infertility in couples. Many men with male infertility have sperm problems such as oligozoospermia, asthenozoospermia, or teratozoospermia. Because abnormal semen parameters are idiopathic to some extent, no standard therapy has been established to date. Herbal medicine has been reported to have beneficial properties in the treatment of subfertility, especially in improving semen quality both in vivo and in human studies. Therefore, we intend to investigate the effectiveness and safety of treatment using Korean medicine (KM) for infertile male patients with poor semen quality.This will be a single-center, prospective, case-only observational pilot study. About 20 male patients with infertility who visit Conmaul Hospital of Korean Medicine will be recruited. We will follow the standard treatment protocol, which has shown good results in the treatment of male infertility. The protocol is composed mainly of a 10-week herbal decoction treatment; acupuncture and/or pharmacopuncture are added when needed. Semen samples, quality of life, and the scrotal temperatures of infertile men will be observed before and after the 10-week treatment with KM.The study has received ethical approval from the Public Institutional Review Board (approval number: P01-201708-21-008). The findings will be disseminated to appropriate audiences via peer-reviewed publication and conference presentations. Korean Clinical Trial Registry (CRIS), Republic of Korea: KCT0002611.

Prospective epidemiological pilot study on the morbidity of bathers exposed to tropical recreational waters and sand.

PubMed

Sánchez-Nazario, Elia E; Santiago-Rodriguez, Tasha M; Toranzos, Gary A

2014-06-01

A prospective cohort epidemiological pilot study was performed at three tropical beaches with point- and non-point-sources of fecal pollution to characterize the risk of illness among swimmers and non-swimmers. There was an increased risk of illness in swimmers as compared to non-swimmers, even when waters met current microbial standards for recreational water quality. Illnesses included gastrointestinal (GI), skin and respiratory symptoms, earache and fever. Odds ratios (ORs) ranged from 0.32 to 42.35 (GI illness), 0.69 to 3.12 (skin infections), 0.71 to 3.21 (respiratory symptoms), 0.52 to 15.32 (earache) and 0.80 to 1.68 (fever), depending on the beach sampled. The indicators that better predicted the risks of symptoms (respiratory) in tropical recreational waters were total (somatic and male-specific) coliphages (OR = 1.56, p < 0.10, R(2) = 3.79%) and Escherichia coli (OR = 1.38, p < 0.10, R(2) = 1.97%). The present study supports the potential of coliphages as good predictors of risks of respiratory illness in tropical recreational waters. This is the first study that has determined risks of illness after exposure to tropical recreational waters with point- and non-point sources of fecal contamination. The results give an opportunity to perform epidemiological studies in tropical recreational waters in Puerto Rico which can include more participants and other indicators and detection techniques.

Adding Paracetamol to Ibuprofen for the Treatment of Patent Ductus Arteriosus in Preterm Infants: A Double-Blind, Randomized, Placebo-Controlled Pilot Study.

PubMed

Hochwald, Ori; Mainzer, Gur; Borenstein-Levin, Liron; Jubran, Huda; Dinur, Gil; Zucker, Meirav; Mor, Malka; Khoury, Asaad; Kugelman, Amir

2018-05-21

 The objective of this study was to compare the closure rate of hemodynamically significant patent ductus arteriosus (hsPDA) of intravenous ibuprofen + paracetamol (acetaminophen) versus ibuprofen + placebo, in preterm infants of 24 to 31 6/7 weeks postmenstrual age.  This is a single-center, double-blind, randomized controlled pilot study. Infants were assigned for treatment with either intravenous ibuprofen + paracetamol ( n  = 12) or ibuprofen + placebo ( n  = 12).  There was no statistical difference in baseline characteristics of the two groups. Echocardiography parameters were comparable before treatment in both groups. There was a trend toward higher hsPDA closure rate in the paracetamol group in comparison to the placebo group (83 vs. 42%, p  = 0.08). No adverse effects, clinical or laboratory, were associated with adding paracetamol.  Our pilot study was unable to detect a beneficial effect by adding intravenous paracetamol to ibuprofen for the treatment of hsPDA. Larger prospective studies are needed to explore the positive tendency suggested by our results and to assure safety. Thieme Medical Publishers 333 Seventh Avenue, New York, NY 10001, USA.

Proton pump inhibitors and vascular function: A prospective cross-over pilot study.

PubMed

Ghebremariam, Yohannes T; Cooke, John P; Khan, Fouzia; Thakker, Rahul N; Chang, Peter; Shah, Nigam H; Nead, Kevin T; Leeper, Nicholas J

2015-08-01

Proton pump inhibitors (PPIs) are commonly used drugs for the treatment of gastric reflux. Recent retrospective cohorts and large database studies have raised concern that the use of PPIs is associated with increased cardiovascular (CV) risk. However, there is no prospective clinical study evaluating whether the use of PPIs directly causes CV harm. We conducted a controlled, open-label, cross-over pilot study among 21 adults aged 18 and older who are healthy (n=11) or have established clinical cardiovascular disease (n=10). Study subjects were assigned to receive a PPI (Prevacid; 30 mg) or a placebo pill once daily for 4 weeks. After a 2-week washout period, participants were crossed over to receive the alternate treatment for the ensuing 4 weeks. Subjects underwent evaluation of vascular function (by the EndoPAT technique) and had plasma levels of asymmetric dimethylarginine (ADMA, an endogenous inhibitor of endothelial function previously implicated in PPI-mediated risk) measured prior to and after each treatment interval. We observed a marginal inverse correlation between the EndoPAT score and plasma levels of ADMA (r = -0.364). Subjects experienced a greater worsening in plasma ADMA levels while on PPI than on placebo, and this trend was more pronounced amongst those subjects with a history of vascular disease. However, these trends did not reach statistical significance, and PPI use was also not associated with an impairment in flow-mediated vasodilation during the course of this study. In conclusion, in this open-label, cross-over pilot study conducted among healthy subjects and coronary disease patients, PPI use did not significantly influence vascular endothelial function. Larger, long-term and blinded trials are needed to mechanistically explain the correlation between PPI use and adverse clinical outcomes, which has recently been reported in retrospective cohort studies. © The Author(s) 2015.

Effect of trelagliptin on vascular endothelial functions and serum adiponectin level in patients with type 2 diabetes: a preliminary single-arm prospective pilot study.

PubMed

Ida, Satoshi; Murata, Kazuya; Betou, Katunori; Kobayashi, Chiaki; Ishihara, Yuki; Imataka, Kanako; Uchida, Akihiro; Monguchi, Kou; Kaneko, Ryutaro; Fujiwara, Ryoko; Takahashi, Hiroka

2016-11-04

Trelagliptin, an oral DPP-4 inhibitor, which is administered once per week and characterized by a long half-life in blood. The effects of trelagliptin on vascular endothelial functions have not been clarified to date. The objective of the present study was to examine the effects of trelagliptin on vascular endothelial functions in patients with type 2 diabetes mellitus (DM) using flow-mediated dilatation (FMD), adiponectin, and asymmetric dimethylarginine (ADMA) as evaluation indicators. This study was a preliminary single-arm prospective pilot study. The subjects of this study were type 2 DM patients aged 20-74 years, who visited our outpatient department. The patients were treated with trelagliptin, and their FMD, adiponectin, and ADMA levels were measured at baseline and at 12 weeks after initial treatment to determine the changes during the study period. A total of 27 patients, excluding three dropouts, were included in the population for analysis. Trelagliptin treatment showed no significant changes in FMD (2.42 ± 2.7% at baseline vs. 2.66 ± 3.8% post-treatment, P = 0.785) and ADMA (0.41 ± 0.0 µg/mL at baseline vs. 0.40 ± 0.0 µg/mL post-treatment, P = 0.402). Trelagliptin treatment resulted in a significant increase of serum adiponectin level (7.72 ± 6.9 µg/mL at baseline vs. 8.82 ± 8.3 µg/mL post-treatment, P < 0.002). In this pilot study, trelagliptin treatment showed no significant changes in FMD. On the other hand, it was believed that trelagliptin treatment may increase serum adiponectin level. Trial Registration http://www.umin.ac.jp (Trial ID UMIN000018311).

Adaptive Automation and Cue Invocation: The Effect of Cue Timing on Operator Error

DTIC Science & Technology

2013-05-01

129. 5. Parasuraman, R. (2000). Designing automation for human use: Empirical studies and quantitative models. Ergonomics , 43, 931-951. 6...Prospective memory errors involve memory for intended actions that are planned to be performed at some designated point in the future [20]. In the DMOO...RESCHU) [21] was used in this study. A Navy pilot who is familiar with supervisory control tasks designed the RESCHU task and the task has been

Biodegradable magnesium-based screw clinically equivalent to titanium screw in hallux valgus surgery: short term results of the first prospective, randomized, controlled clinical pilot study

PubMed Central

2013-01-01

Purpose Nondegradable steel-and titanium-based implants are commonly used in orthopedic surgery. Although they provide maximal stability, they are also associated with interference on imaging modalities, may induce stress shielding, and additional explantation procedures may be necessary. Alternatively, degradable polymer implants are mechanically weaker and induce foreign body reactions. Degradable magnesium-based stents are currently being investigated in clinical trials for use in cardiovascular medicine. The magnesium alloy MgYREZr demonstrates good biocompatibility and osteoconductive properties. The aim of this prospective, randomized, clinical pilot trial was to determine if magnesium-based MgYREZr screws are equivalent to standard titanium screws for fixation during chevron osteotomy in patients with a mild hallux valgus. Methods Patients (n=26) were randomly assigned to undergo osteosynthesis using either titanium or degradable magnesium-based implants of the same design. The 6 month follow-up period included clinical, laboratory, and radiographic assessments. Results No significant differences were found in terms of the American Orthopaedic Foot and Ankle Society (AOFAS) score for hallux, visual analog scale for pain assessment, or range of motion (ROM) of the first metatarsophalangeal joint (MTPJ). No foreign body reactions, osteolysis, or systemic inflammatory reactions were detected. The groups were not significantly different in terms of radiographic or laboratory results. Conclusion The radiographic and clinical results of this prospective controlled study demonstrate that degradable magnesium-based screws are equivalent to titanium screws for the treatment of mild hallux valgus deformities. PMID:23819489

A pilot study of audiovisual family meetings in the intensive care unit.

PubMed

de Havenon, Adam; Petersen, Casey; Tanana, Michael; Wold, Jana; Hoesch, Robert

2015-10-01

We hypothesized that virtual family meetings in the intensive care unit with conference calling or Skype videoconferencing would result in increased family member satisfaction and more efficient decision making. This is a prospective, nonblinded, nonrandomized pilot study. A 6-question survey was completed by family members after family meetings, some of which used conference calling or Skype by choice. Overall, 29 (33%) of the completed surveys came from audiovisual family meetings vs 59 (67%) from control meetings. The survey data were analyzed using hierarchical linear modeling, which did not find any significant group differences between satisfaction with the audiovisual meetings vs controls. There was no association between the audiovisual intervention and withdrawal of care (P = .682) or overall hospital length of stay (z = 0.885, P = .376). Although we do not report benefit from an audiovisual intervention, these results are preliminary and heavily influenced by notable limitations to the study. Given that the intervention was feasible in this pilot study, audiovisual and social media intervention strategies warrant additional investigation given their unique ability to facilitate communication among family members in the intensive care unit. Copyright © 2015 Elsevier Inc. All rights reserved.

Numerical Simulations Of High-Altitude Aerothermodynamics Of A Prospective Spacecraft Model

NASA Astrophysics Data System (ADS)

Vashchenkov, P. V.; Kaskovsky, A. V.; Krylov, A. N.; Ivanov, M. S.

2011-05-01

The paper describes the computations of aerothermodynamic characteristics of a promising spacecraft (Prospective Piloted Transport System) along its de- scent trajectory at altitudes from 120 to 60 km. The computations are performed by the DSMC method with the use of the SMILE software system and by the engineering technique (local bridging method) with the use of the RuSat software system. The influence of real gas effects (excitation of rotational and vibrational energy modes and chemical reactions) on aerothermodynamic characteristics of the vehicle is studied. A comparison of results obtained by the approximate engineering method and the DSMC method allow the accuracy of prediction of aerodynamic characteristics by the local bridging method to be estimated.

[Surgical site infections after cesarean section: results of a five-year prospective surveillance].

PubMed

Barbut, F; Carbonne, B; Truchot, F; Spielvogel, C; Jannet, D; Goderel, I; Lejeune, V; Milliez, J

2004-10-01

To determine the incidence of surgical site infections and to identify risk factors for infections. A prospective study of surgical site infections (SSI) after cesarean section was carried out from September 1997 to September 1998 (pilot study) and from January 2000 to August 2003, using the methodology of the American National Nosocomial Infection Surveillance System. Follow up of women was performed by midwives until discharge and during the post-natal visit. Suspected surgical site infections were confirmed by surgeons and infection control practitioners. The microbiological file of each patient was edited 30 days after cesarean section. Risk factors were analyzed using a logistic regression model. During the pilot study, infection rate was estimated at 3.2%. At multivariate analysis, factors independently associated with an increased risk of SSI were ASA score > 1, performance of cesarean section in a room not dedicated to this activity, and use of an open urine drainage system. During the following years (2000-2003), infection rates progressively decreased to reach 1.9% in 2003. Infections included superficial wound infections (involving skin and subcutaneous tissue) (47%), deep wound infections (involving deep and soft tissue (fascia and muscle) (20%) and organ/space infections (i.e. endometritis, pelvic abscess) (33%). Infections occurred after patient discharge in 47.5% of cases and diagnosis was based only on clinical findings in 30% of cases. Infected patients were hospitalized longer (median: 6 days) than non infected patients. Prospective surveillance of SSI led to better awareness of infectious problems among health care workers, to identification of risk factors and evaluation of health procedures. Surveillance contributed to a decrease in nosocomial infections.

Intra-articular injections of HYADD4-G in male professional soccer players with traumatic or degenerative knee chondropathy. A pilot, prospective study.

PubMed

Tamburrino, Pasquale; Castellacci, Enrico

2016-12-01

Knee injuries are very common in some sports and particularly in soccer due to the highly repetitive loading of the mechanical stress involved in this practice. Knee-joint injuries account for 40% of all different kinds of lesions. Traumatic or degenerative patellofemoral or tibialfemoral chondropaties of knee cause disabling symptoms, joint pain and/or dysfunctions. The aim of the study was to evaluate the effects of HYADD4-G, a hydrogel based on a hyaluronic acid derivative, in professional soccer players affected by traumatic or degenerative knee chondropathy. Thirty male professional soccer players participants in the Italian League 2014-2015, affected by traumatic or degenerative knee patellofemoral (N.=12) or tibiofemoral (N.=18) chondropathy assessed through MRI and/or arthroscopy of knee joints and the ICRS staging (International Cartilage Repair Society ≤3a), were enrolled in this pilot prospective study. Patients underwent 2 intra-articular (IA) injections of HYADD4-G (3 mL of 8 mg/mL) at one week interval. Patients were prospectively evaluated at baseline and then at 1, 3 and 6 months after the treatment by the Osteoarthritis Outcome Score (KOOS) Score (main outcome) and by the Visual Analog Scale (VAS) to evaluate pain. A significant improvement in all clinical endpoints from pretreatment to different times of evaluation was found in all patients. ANOVA with repeated measure using the SPSS has showed significantly better results in term of KOOS and VAS scores at 1, 3 and 6 months compared to the pre-injection value (P<0.05). IA HYADD4-G is highly effective to improve resting and walking pain in professional male soccer players with traumatic or degenerative knee chondropathy.

[Multicenter paragliding accident study 1990].

PubMed

Lautenschlager, S; Karli, U; Matter, P

1992-01-01

During the period from 1.1.90 until 31.12.90, 86 injuries associated with paragliding were analyzed in a prospective study in 12 different Swiss hospitals with reference to causes, patterns, and frequencies. The injuries showed a mean score of over 2 and were classified as severe. Most frequent spine injuries (36%) and lesions of the lower extremity (35%) with a high risk of the ankles were diagnosed. One accident was fatal. 60% of the accidents happened during landing, 26% during launching and 14% during flight. Half of the pilots were affected during their primary training course. Most accidents were caused by inflight error of judgement--especially incorrect estimation of wind conditions--and further the choice of unfavourable landing sites. In contrast to previous injury-reports, only one equipment failure could be noted, but often the equipment was not corresponding with the experience and the weight of the pilot. To reduce the frequency of paragliding-injuries an accurate choice of equipment and an increased attention to environmental factors is mandatory. Furthermore an education-program regarding the attitude and intelligence of the pilot should be included in training courses.

2, 6, Heave! Sail Training's Influence on the Development of Self-Concept and Social Networks and Their Impact on Engagement with Learning and Education. A Pilot Study

ERIC Educational Resources Information Center

Henstock, Murray; Barker, Katrina; Knijnik, Jorge

2013-01-01

It is difficult to provide disengaged youth, who are at risk of not fulfilling their potential, with the social support necessary to remain active contributors to society. They are more likely to fail and drop from education greatly reducing the prospect of becoming constructive, productive community members. Consequently strategies to promote…

Longitudinal Brain Magnetic Resonance Imaging CO2 Stress Testing in Individual Adolescent Sports-Related Concussion Patients: A Pilot Study.

PubMed

Mutch, W Alan C; Ellis, Michael J; Ryner, Lawrence N; Morissette, Marc P; Pries, Philip J; Dufault, Brenden; Essig, Marco; Mikulis, David J; Duffin, James; Fisher, Joseph A

2016-01-01

Advanced neuroimaging studies in concussion have been limited to detecting group differences between concussion patients and healthy controls. In this small pilot study, we used brain magnetic resonance imaging (MRI) CO2 stress testing to longitudinally assess cerebrovascular responsiveness (CVR) in individual sports-related concussion (SRC) patients. Six SRC patients (three males and three females; mean age = 15.7, range = 15-17 years) underwent longitudinal brain MRI CO2 stress testing using blood oxygen level-dependent (BOLD) MRI and model-based prospective end-tidal CO2 targeting under isoxic conditions. First-level and second-level comparisons were undertaken using statistical parametric mapping (SPM) to score the scans and compare them to an atlas of 24 healthy control subjects. All tests were well tolerated and without any serious adverse events. Anatomical MRI was normal in all study participants. The CO2 stimulus was consistent between the SRC patients and control subjects and within SRC patients across the longitudinal study. Individual SRC patients demonstrated both quantitative and qualitative patient-specific alterations in CVR (p < 0.005) that correlated strongly with clinical findings, and that persisted beyond clinical recovery. Standardized brain MRI CO2 stress testing is capable of providing a longitudinal assessment of CVR in individual SRC patients. Consequently, larger prospective studies are needed to examine the utility of brain MRI CO2 stress testing as a clinical tool to help guide the evaluation, classification, and longitudinal management of SRC patients.

Performance of a quantitative fecal immunochemical test in a colorectal cancer screening pilot program: a prospective cohort study.

PubMed

Telford, Jennifer; Gentile, Laura; Gondara, Lovedeep; McGahan, Colleen; Coldman, Andrew

2016-01-01

British Columbia undertook a colorectal cancer screening pilot program in 3 communities. Our objective was to assess the performance of 2-specimen fecal immunochemical testing in the detection of colorectal neoplasms in this population-based screening program. A prospective cohort of asymptomatic, average-risk people aged 50 to 74 years completed 2 quantitative fecal immunochemical tests every 2 years, with follow-up colonoscopy if the result of either test was positive. Participant demographics, fecal immunochemical test results, colonoscopy quality indicators and pathology results were recorded. Non-screen-detected colorectal cancer that developed in program participants was identified through review of data from the BC Cancer Registry. A total of 16 234 people completed a first round of fecal immunochemical testing, with a positivity rate of 8.6%; 5378 (86.0% of eligible participants) completed a second round before the end of the pilot program, with a positivity rate of 6.7%. Of the 1756 who had a positive test result, 1555 (88.6%) underwent colonoscopy. The detection rate of colorectal cancer was 3.5 per 1000 participants. The positive predictive value of the fecal immunochemical test was 4.9% (95% confidence interval [CI] 3.8%-6.0%) for colorectal cancer, 35.0% (95% CI 32.5%-37.2%) for high-risk polyps and 62.0% (95% CI 59.6%-64.4%) for all neoplasms. The number needed to screen was 283 to detect 1 cancer, 40 to detect 1 high-risk polyp and 22 to detect any neoplasm. Screening every 2 years with a 2-specimen fecal immunochemical test surpassed the current benchmark for colorectal cancer detection in population-based screening. This study has implications for other jurisdictions planning colorectal cancer screening programs.

β-trace protein as a diagnostic marker for perilymphatic fluid fistula: a prospective controlled pilot study to test a sample collection technique.

PubMed

Bachmann-Harildstad, Gregor; Stenklev, Niels Christian; Myrvoll, Elin; Jablonski, Greg; Klingenberg, Olav

2011-01-01

The diagnosis of perilymphatic fluid (PLF) fistula is still challenging. Perilymphatic fluid fistula is one possible complication after stapedotomy or cochlear implant surgery. We have performed a prospective diagnostic pilot study to further investigate β-trace protein (β-TP) as a marker for PLF fistula. In this pilot study, we tested the sensitivity of the β-TP marker using a simple method for sample collection from the tympanic cavity. Prospective controlled diagnostic study. Two-center tertiary referral hospitals. A total of 35 adult patients undergoing ear surgery were included. Subjects were divided into 2 groups: 1) 19 patients undergoing stapedotomy were investigated for PLF fistula in samples obtained from the tympanic cavity and 2) 16 patients undergoing myringoplasty were investigated for PLF fistula in samples from the tympanic cavity. This group served as the control. Mean age +/- SD at surgery was 49.9 +/- 8.0 years in the study group and 39.69 +/- 15.47 years in the control group. β-Trace protein (prostaglandin D synthase) in tympanic cavity samples and serum samples was analyzed. The samples were collected by gradually filling the tympanic cavity with 100 to 200 μl sodium chloride and by immediately collecting a volume of 60 to 100 μl in a mucus specimen set container. The concentration of β-TP was quantified using laser nephelometry. The median β-TP in the study group was 0.8 mg/L (range, 0.05-4.5 mg/L). In the control group, the median β-TP value was 0.16 mg/L (range, 0.01-0.36 mg/L). Thirty-five percent of the values in the study group were below the highest value in the negative control group. The β-TP values of the tympanic cavity samples were significantly higher in the study group than in controls (p = 0.0001). The serum values were 0.55 +/- 0.18 and 0.53 +/- 0.11 mg/L, respectively. It may be feasible to test for PLF fistula using β-TP in samples from the tympanic cavity. Our results, however, suggest a relative low diagnostic sensitivity, given a cutoff that is set to obtain a high specificity when using a simple sample collection method. Furthermore, the test does not permit the distinction between PLF fistula and cerebrospinal fluid fistula. Further studies should focus on minimal dilution at sampling and on minimizing sample volumes.

Examination of staphylococcal stethoscope contamination in the emergency department (pilot) study (EXSSCITED pilot study).

PubMed

Tang, Patrick H P; Worster, Andrew; Srigley, Jocelyn A; Main, Cheryl L

2011-07-01

The objective of this study was to determine the prevalence of Staphylococcus-contaminated stethoscopes belonging to emergency department (ED) staff and to identify the proportion of these that were Staphylococcus aureus or methicillin-resistant Staphylococcus aureus (MRSA). We conducted a prospective observational cohort study of bacterial cultures from 100 ED staff members' stethoscopes at three EDs. Study participants were asked to complete a questionnaire. Fifty-four specimens grew coagulase-negative staphylococci and one grew methicillin-susceptible S. aureus. No MRSA was cultured. Only 8% of participants, all of whom were nurses, reported cleaning their stethoscope before or after each patient assessment. Alcohol-based wipes were most commonly used to clean stethoscopes. A lack of time, being too busy, and forgetfulness were the most frequently reported reasons for not cleaning the stethoscope in the ED. This study indicates that although stethoscope contamination rates in these EDs are high, the prevalence of S. aureus or MRSA on stethoscopes is low.

Call-related factors influencing output power from mobile phones.

PubMed

Hillert, Lena; Ahlbom, Anders; Neasham, David; Feychting, Maria; Järup, Lars; Navin, Roshan; Elliott, Paul

2006-11-01

Mobile phone use is increasing but there is also concern for adverse health effects. Well-designed prospective studies to assess several health outcomes are required. In designing a study of mobile phone use, it is important to assess which factors need to be considered in classifying the exposure to radiofrequency fields (RF). A pilot study was performed in Sweden and in the UK 2002 to 2003 to test the feasibility of recruiting a cohort of mobile phone users from a random population sample and from mobile phone subscription lists for a prospective study. As one part of this pilot study, different factors were evaluated regarding possible influence on the output power of the phones. By local switch logging, information on calls made from predefined subscriptions or dedicated handsets were obtained and the output power of phones during calls made indoors and outdoors, in moving and stationary mode, and in rural as well in urban areas were compared. In this experiment, calls were either 1, 1.5 or 5 min long. The results showed that high mobile phone output power is more frequent in rural areas whereas the other factors (length of call, moving/stationary, indoor/outdoor) were of less importance. Urban and rural area should be considered in an exposure index for classification of the exposure to RF from mobile phones and may be assessed by first base station during mobile phone calls or, if this information is not available, possibly by using home address as a proxy.

The Effect of Pre-Emptive Administration of Dextromethorphan on Postoperative Pain in Patients Undergoing Interval Laparoscopic Tubal Sterilization

DTIC Science & Technology

2001-10-01

requirements following surgery. Dextromethorphan , a readily available nonopioid antitussive in clinical use for more than 40 years, is one such NMDA...receptor Anticosti. This prospective, randomized, double blind pilot study compared the effects over time when patients received dextromethorphan versus...groups. Group I received 60 mg of dextromethorphan orally, and Group II received an oral placebo. Postoperative pain was assessed using an 11 point

Procedures for assessing psychological predictors of injuries in circus artists: a pilot prospective study.

PubMed

Shrier, Ian; Raglin, John S; Levitan, Emily B; Mittleman, Murray A; Steele, Russell J; Powell, Janette

2014-06-11

Research on psychological risk factors for injury has focused on stable traits. Our objective was to test the feasibility of a prospective longitudinal study designed to examine labile psychological states as risk factors of injury. We measured psychological traits at baseline (mood, ways of coping and anxiety), and psychological states every day (1-item questions on anxiety, sleep, fatigue, soreness, self-confidence) before performances in Cirque du Soleil artists of the show "O". Additional questions were added once per week to better assess anxiety (20-item) and mood. Questionnaires were provided in English, French, Russian and Japanese. Injury and exposure data were extracted from electronic records that are kept as part of routine business practices. The 43.9% (36/82) recruitment rate was more than expected. Most artists completed the baseline questionnaires in 15 min, a weekly questionnaire in <2 min and a daily questionnaire in <1 min. We improved the formatting of some questions during the study, and adapted the wording of other questions to improve clarity. There were no dropouts during the entire study, suggesting the questionnaires were appropriate in content and length. Results for sample size calculations depend on the number of artists followed and the minimal important difference in injury rates, but in general, preclude a purely prospective study with daily data collection because of the long follow-up required. However, a prospective nested case-crossover design with data collection bi-weekly and at the time of injury appears feasible. A prospective study collecting psychological state data from subjects who train and work regularly together is feasible, but sample size calculations suggest that the optimal study design would use prospective nested case-crossover methodology.

Procedures for assessing psychological predictors of injuries in circus artists: a pilot prospective study

PubMed Central

2014-01-01

Background Research on psychological risk factors for injury has focused on stable traits. Our objective was to test the feasibility of a prospective longitudinal study designed to examine labile psychological states as risk factors of injury. Methods We measured psychological traits at baseline (mood, ways of coping and anxiety), and psychological states every day (1-item questions on anxiety, sleep, fatigue, soreness, self-confidence) before performances in Cirque du Soleil artists of the show “O”. Additional questions were added once per week to better assess anxiety (20-item) and mood. Questionnaires were provided in English, French, Russian and Japanese. Injury and exposure data were extracted from electronic records that are kept as part of routine business practices. Results The 43.9% (36/82) recruitment rate was more than expected. Most artists completed the baseline questionnaires in 15 min, a weekly questionnaire in <2 min and a daily questionnaire in <1 min. We improved the formatting of some questions during the study, and adapted the wording of other questions to improve clarity. There were no dropouts during the entire study, suggesting the questionnaires were appropriate in content and length. Results for sample size calculations depend on the number of artists followed and the minimal important difference in injury rates, but in general, preclude a purely prospective study with daily data collection because of the long follow-up required. However, a prospective nested case-crossover design with data collection bi-weekly and at the time of injury appears feasible. Conclusion A prospective study collecting psychological state data from subjects who train and work regularly together is feasible, but sample size calculations suggest that the optimal study design would use prospective nested case-crossover methodology. PMID:24920527

Efficacy and safety of a new coverlet device on skin microclimate management: a pilot study in critical care patients.

PubMed

Forriez, O; Masseline, J; Coadic, D; David, V; Trouiller, P; Sztrymf, B

2017-02-02

To test the effect of a new coverlet device, allowing air circulation at the body/underlying surface interface, on skin microclimate management. This prospective observational pilot study took place in a 15-bed university-affiliated intensive care unit. Overall, 34 mechanically ventilated patients were included. Skin humidity and temperature were monitored before and after the implementation of the tested device at the occiput, scapulas, buttocks and sacrum. Humidity and temperature were evaluated through surface skin impedance and an infra-red thermometer, respectively. Health professionals were asked to evaluate the device. After implementation of the coverlet device, there was a rapid, sustained and significant decrease in skin humidity at all sites ranging from 6 % to 15 %, excluding the occiput. Skin temperature also significantly decreased from 1 % at both scapulas, but not at the other studied body sites. No side effects were observed. Health professionals reported that the device was easy and quick to install. Although they did not report a subjective improvement in skin moisture or temperature, they considered the device to be efficient. Although limited by its design, this pilot study suggests a good efficacy of the studied device on skin microclimate management. Further data are warranted to test the clinical implications of our findings.

Therapeutic Lifestyle Changes: Impact on Weight, Quality of Life, and Psychiatric Symptoms in Veterans With Mental Illness.

PubMed

Tessier, Jillian M; Erickson, Zachary D; Meyer, Hilary B; Baker, Matthew R; Gelberg, Hollie A; Arnold, Irina Y; Kwan, Crystal; Chamberlin, Valery; Rosen, Jennifer A; Shah, Chandresh; Hellemann, Gerhard; Lewis, Melissa M; Nguyen, Charles; Sachinvala, Neena; Amrami, Binyamin; Pierre, Joseph M; Ames, Donna

2017-09-01

Veterans with mental illness tend to have shorter life spans and suboptimal physical health because of a variety of factors. These factors include poor nutrition, being overweight, and smoking cigarettes. Nonphysical contributors that may affect quality of life are the stigma associated with mental illness, social difficulties, and spiritual crises. Current mental health treatment focuses primarily on the delivery of medication and evidence-based psychotherapies, which may not affect all the above areas of a Veteran's life as they focus primarily on improving psychological symptoms. Clinicians may find greater success using integrative, comprehensive, multifaceted programs to treat these problems spanning the biological, psychological, social, and spiritual domains. These pilot studies test an adjunctive, holistic, behavioral approach to treat mental illness. This pilot work explores the hypotheses that engagement in a greater number of therapeutic lifestyle changes (TLCs) leads to improvement in quality of life, reduction of psychiatric symptoms, and weight loss. Institutional Review Boards for human subjects at the Veterans Affairs (VA) Greater Los Angeles and Long Beach Healthcare Systems approved pilot study activities at their sites. Pilot Study 1 was a prospective survey study of Veterans with mental illness, who gained weight on an atypical antipsychotic medication regimen, participating in a weight management study. At each session of the 1-year study, researchers asked a convenience sample of 55 Veterans in the treatment arm whether they engaged in each of the eight TLCs: exercise, nutrition/diet, stress management and relaxation, time in nature, relationships, service to others, religious or spiritual involvement, and recreation. Pilot Study 2 applied the TLC behavioral intervention and examined 19 Veterans with mental illness, who attended four classes about TLCs, received individual counseling over 9 weeks, and maintained journals to track TLC practice. Besides weekly journals, researchers also collected prospective data on quality of life, psychiatric symptoms, vitals, and anthropometric measurements. In both studies, investigators tested for main effects of the total number of TLCs practiced and study week using mixed-effects linear models with independent intercepts by participant. In Study 1, engagement in more TLC behaviors was significantly associated with higher ratings of quality of life, as well as greater weight loss for each additional type of TLC practiced. In Study 2, TLC practice increased significantly over 9 weeks, and was significantly associated with improvements in quality of life and diastolic blood pressure. Counseling Veterans to practice TLCs provides a holistic adjunct to current treatments for mental illness. TLCs may confer multiple benefits upon Veterans with mental illness, enhancing quality of life and well-being along with weight management efforts. As these were pilot studies, the samples sizes were relatively small and a control group was lacking. Our findings may have broader implications supporting a holistic approach in both primary and mental health care settings. Future research will expand this work to address its weaknesses and examine the cost differential between this holistic approach and traditional mental health treatment. Reprint & Copyright © 2017 Association of Military Surgeons of the U.S.

Clay jojoba oil facial mask for lesioned skin and mild acne--results of a prospective, observational pilot study.

PubMed

Meier, Larissa; Stange, Rainer; Michalsen, Andreas; Uehleke, Bernhard

2012-01-01

External application of clay facial masks is a cosmetic procedure generally used to reduce skin lesions and to improve overall skin condition. Collecting pilot data about self-treatment with clay jojoba oil masks on participants with acne-prone, lesioned skin and acne. Open, prospective, observational pilot study: Participants received written information, instructions, and questionnaires without direct contact with the study physician. For 6 weeks, they applied the masks 2-3 times per week. The primary outcome is the difference of skin lesions: baseline vs. after 6 weeks. 194 participants (192 female, 2 male, mean age (± SE) (32.3 ± 0.7 years) returned questionnaires and diaries. 133 of these participants returned complete and precise lesion counts (per-protocol (PP) collective). A 54% mean reduction in total lesion count was observed after 6 weeks of treatment with clay facial mask. Both inflammatory and non-inflammatory skin lesions were reduced significantly after treatment compared to baseline: Median counts (MC) of pustules per affected participant were reduced from 7.0 ± 0.9 to 3.0 ± 0.5 (mean individual reduction (MIR) = 49.4%), the MC of the papules from 3.5 ± 2.2 to 1.0 ± 0.4 (MIR = 57.3%), the MC of cysts from 2.0 ± 0.8 to 0.5 ± 0.4 (MIR = 68.6%) and the MC of comedones from 26.5 ± 6.3 to 16.0 ± 4.0 (MIR = 39.1%). DLQI-average score decreased from 5.0 ± 4.5 (mean ± SE) before to 2.1 ± 2.8 after treatment. The present study gives preliminary evidence that healing clay jojoba oil facial masks can be effective treatment for lesioned skin and mild acne vulgaris. Copyright © 2012 S. Karger AG, Basel.

Tryptophan metabolism, its relation to inflammation and stress markers and association with psychological and cognitive functioning: Tasmanian Chronic Kidney Disease pilot study.

PubMed

Karu, Naama; McKercher, Charlotte; Nichols, David S; Davies, Noel; Shellie, Robert A; Hilder, Emily F; Jose, Matthew D

2016-11-10

Adults with chronic kidney disease (CKD) exhibit alterations in tryptophan metabolism, mainly via the kynurenine pathway, due to higher enzymatic activity induced mainly by inflammation. Indoles produced by gut-microflora are another group of tryptophan metabolites related to inflammation and conditions accompanying CKD. Disruptions in tryptophan metabolism have been associated with various neurological and psychological disorders. A high proportion of CKD patients self-report symptoms of depression and/or anxiety and decline in cognitive functioning. This pilot study examines tryptophan metabolism in CKD and explores associations with psychological and cognitive functioning. Twenty-seven adults with CKD were part of 49 patients recruited to participate in a prospective pilot study, initially with an eGFR of 15-29 mL/min/1.73 m 2 . Only participants with viable blood samples and complete psychological/cognitive data at a 2-year follow-up were included in the reported cross-sectional study. Serum samples were analysed by Liquid Chromatography coupled to Mass Spectrometry, for tryptophan, ten of its metabolites, the inflammation marker neopterin and the hypothalamic-pituitary-adrenal (HPA) axis marker cortisol. The tryptophan breakdown index (kynurenine / tryptophan) correlated with neopterin (Pearson R = 0.51 P = 0.006) but not with cortisol. Neopterin levels also correlated with indoxyl sulfate (R = 0.68, P < 0.0001) and 5 metabolites of tryptophan (R range 0.5-0.7, all P ≤ 0.01), which were all negatively related to eGFR (P < 0.05). Higher levels of kynurenic acid were associated with lower cognitive functioning (Spearman R = -0.39, P < 0.05), while indole-3 acetic acid (IAA) was correlated with anxiety and depression (R = 0.52 and P = 0.005, R = 0.39 and P < 0.05, respectively). The results of this preliminary study suggest the involvement of inflammation in tryptophan breakdown via the kynurenine pathway, yet without sparing tryptophan metabolism through the 5-HT (serotonin) pathway in CKD patients. The multiple moderate associations between indole-3 acetic acid and psychological measures were a novel finding. The presented pilot data necessitate further exploration of these associations within a large prospective cohort to assess the broader significance of these findings.

Clinical Efficacy and Safety of Oral Qing-Dai in Patients with Ulcerative Colitis: A Single-Center Open-Label Prospective Study.

PubMed

Sugimoto, Shinya; Naganuma, Makoto; Kiyohara, Hiroki; Arai, Mari; Ono, Keiko; Mori, Kiyoto; Saigusa, Keiichiro; Nanki, Kosaku; Takeshita, Kozue; Takeshita, Tatsuya; Mutaguchi, Makoto; Mizuno, Shinta; Bessho, Rieko; Nakazato, Yoshihiro; Hisamatsu, Tadakazu; Inoue, Nagamu; Ogata, Haruhiko; Iwao, Yasushi; Kanai, Takanori

2016-01-01

Chinese herbal medicine Qing-Dai (also known as indigo naturalis) has been used to treat various inflammatory conditions. However, not much has been studied about the use of oral Qing-Dai in the treatment for ulcerative colitis (UC) patients. Studies exploring alternative treatments for UC are of considerable interest. In this study, we aimed at prospectively evaluating the safety and efficacy of Qing-Dai for UC patients. The open-label, prospective pilot study was conducted at Keio University Hospital. A total of 20 patients with moderate UC activity were enrolled. Oral Qing-Dai in capsule form was taken twice a day (daily dose, 2 g) for 8 weeks. At week 8, the rates of clinical response, clinical remission, and mucosal healing were 72, 33, and 61%, respectively. The clinical and endoscopic scores, CRP levels, and fecal occult blood results were also significantly improved. We observed 2 patients with mild liver dysfunction; 1 patient discontinued due to infectious colitis and 1 patient discontinued due to mild nausea. This is the first prospective study indicating that oral Qing-Dai is effective for inducing remission in patients with moderate UC activity and can be tolerated. Thus, Qing-Dai may be considered an alternative treatment for patients, although further investigation is warranted. © 2016 S. Karger AG, Basel.

A PILOT STUDY OF TOPICAL IMIQUIMOD THERAPY FOR THE TREATMENT OF RECURRENT EXTRAMAMMARY PAGET'S DISEASE

PubMed Central

Cowan, Renee A.; Black, Destin R.; Hoang, Lien N.; Park, Kay J.; Soslow, Robert A.; Backes, Floor J.; Gardner, Ginger J.; Abu-Rustum, Nadeen R.; Leitao, Mario M.; Eisenhauer, Eric L.; Chi, Dennis S.

2016-01-01

Objective The objective of this prospective pilot study was to assess the clinical and histologic effects of topical imiquimod therapy on recurrent extramammary Paget's disease of the vulva. Methods Patients with biopsy-proven recurrent extramammary Paget's disease presenting to the gynecology outpatient services at two participating institutions were recruited for conservative treatment with 5% imiquimod cream from 2007 to 2011. The topical cream was to be applied 3 times per week for 12 weeks. Punch biopsy and photography were performed at baseline and at the 12-week time point. Results Eight patients from two institutions were enrolled. Complete clinical and histologic response was achieved in 6 (75%) patients by the 12-week follow-up appointment. Of the two remaining patients, one had a complete clinical response but no significant histologic response; the other patient was removed from the study protocol secondary to intolerable local irritation. Two patients continue to have no evidence of disease after a median follow-up of 35 months. Five are alive with disease. No patients progressed to invasive cancer while receiving therapy. Conclusion Topical 5% imiquimod cream is a safe and feasible option for women suffering from recurrent extramammary Paget's disease of the vulva, and should be considered as a viable alternative to surgical management. Given the rare nature of this disease, additional multi-institutional prospective studies should be conducted to explore the efficacy of this treatment regime. PMID:27112632

The Pilot Programme for Teacher Education at Dalhousie University

ERIC Educational Resources Information Center

Bremer, Anne

1973-01-01

A program for prospective elementary school teachers was structured so that students' learning activities including continuous planning and evaluation, were metaphors for the experiences they wished to engender as professional teachers. The metaphorical principle is elaborated. (Author/JA)

Validation of exposure assessment and assessment of recruitment methods for a prospective cohort study of mobile phone users (COSMOS) in Finland: a pilot study

PubMed Central

2011-01-01

Background The aim of the study was to evaluate the agreement between self-reported and operator-derived estimates of call time based on a three-month monitoring period, as well as the consistency of mobile phone use over time. Alternative approaches to improve participation in a cohort study of mobile phone users were also compared. Methods A total of 5,400 subjects were identified from network operators' subscriber databases for recruitment to the pilot study. Operator and questionnaire data were used to quantify mobile phone use. Operator data were available for a subset of the subjects for a three-month period in three consecutive years. We also evaluated the effect of the length of the questionnaire and one- or two-phase recruitment on participation. Results The average response rate for both questionnaires and recruitment procedures was 12%. The response rate was not affected by the length of the questionnaire or the recruitment method. Operator data were available for 83% of the participants for 2007, the first study year. The agreement between self-reported and operator-derived call times decreased with the level of use among intermediate and heavy mobile phone users. During 2007-2009, mobile phone use increased fairly constantly over time. Conclusions The agreement between self-reported mobile phone use and operator databases was moderate and overestimation of the call time by participants was common. A prospective cohort study would be feasible in Finland, although the potentially low participation rate would increase the resources required for recruitment. PMID:21385407

Identifying Mechanisms that Predict Loss of Control (LOC) Eating Using Ecological Momentary Assessment: A pilot study

DTIC Science & Technology

2013-08-30

the eating episode, a sense of "numbing" while eating, and feelings of shame or guilt after the episode. Cluster analysis was used to illuminate a...relationships including under involvement and critical comments about shape and weight (87; 206). Prospectively, LOC eating predicts increased weight and fat ...tissue. Similarly, cortisol generally reduces the rates of protein and fat synthesis and storage, and stimulates breakdown of these molecules to be

NASA's Single-Pilot Operations Technical Interchange Meeting: Proceedings and Findings

NASA Technical Reports Server (NTRS)

Comerford, Doreen; Brandt, Summer L.; Lachter, Joel B.; Wu, Shu-Chieh; Mogford, Richard H.; Battiste, Vernol; Johnson, Walter W.

2013-01-01

Researchers at the National Aeronautics and Space Administration (NASA) Ames Research Center and Langley Research Center are jointly investigating issues associated with potential concepts, or configurations, in which a single pilot might operate under conditions that are currently reserved for a minimum of two pilots. As part of early efforts, NASA Ames Research Center hosted a technical interchange meeting in order to gain insight from members of the aviation community regarding single-pilot operations (SPO). The meeting was held on April 10-12, 2012 at NASA Ames Research Center. Professionals in the aviation domain were invited because their areas of expertise were deemed to be directly related to an exploration of SPO. NASA, in selecting prospective participants, attempted to represent various relevant sectors within the aviation domain. Approximately 70 people representing government, academia, and industry attended. A primary focus of this gathering was to consider how tasks and responsibilities might be re-allocated to allow for SPO.

The Sequential Binge, a New Therapeutic Approach for Binge Eating: A Pilot Study

PubMed Central

Neveu, Rémi; Neveu, Dorine; Barbalat, Guillaume; Schmidt, Ulrike

2016-01-01

Background and Objectives A sizeable proportion of patients experiencing binge eating do not respond to cognitive behavioral therapy (CBT). We present the sequential binge (SB), a new behavioral intervention that complements CBT, and preliminary results of its effects. SB breaks up the binge into repeated identical sequences of eating separated by incremental pauses. This pattern of ingestion aims at facilitating boredom toward the ingested foods and at turning cognitive control away from binge food restriction. SB is hypothesized to reduce food intake during the binge and the number of daily binges. Methods Prospective pilot study. Fifteen binging patients with previous unsuccessful intensive CBT were given SB as an adjunct to their treatment and were followed up for 16 weeks from admission. All patients were reassessed 47 weeks on average after discharge. Results SB was associated with a 44% relative reduction in the planned food intake (p<0.001), a longer consecutive binge refractory period compared to regular binges (median: 48 hours versus 4 hours, p = 0.002) and an average relative reduction by 26% of binge number the day after each SB (p = 0.004). 47% of patients reached binge abstinence for four consecutive weeks 16 weeks after the first SB. Conclusion This case series shows promising evidence for the use of SB in patients with refractory binge eating. Further evaluation in a prospective randomized controlled trial would be justified. PMID:27832121

Changes in alcohol-related brain networks across the first year of college: a prospective pilot study using fMRI effective connectivity mapping.

PubMed

Beltz, Adriene M; Gates, Kathleen M; Engels, Anna S; Molenaar, Peter C M; Pulido, Carmen; Turrisi, Robert; Berenbaum, Sheri A; Gilmore, Rick O; Wilson, Stephen J

2013-04-01

The upsurge in alcohol use that often occurs during the first year of college has been convincingly linked to a number of negative psychosocial consequences and may negatively affect brain development. In this longitudinal functional magnetic resonance imaging (fMRI) pilot study, we examined changes in neural responses to alcohol cues across the first year of college in a normative sample of late adolescents. Participants (N=11) were scanned three times across their first year of college (summer, first semester, second semester), while completing a go/no-go task in which images of alcoholic and non-alcoholic beverages were the response cues. A state-of-the-art effective connectivity mapping technique was used to capture spatiotemporal relations among brain regions of interest (ROIs) at the level of the group and the individual. Effective connections among ROIs implicated in cognitive control were greatest at the second assessment (when negative consequences of alcohol use increased), and effective connections among ROIs implicated in emotion processing were lower (and response times were slower) when participants were instructed to respond to alcohol cues compared to non-alcohol cues. These preliminary findings demonstrate the value of a prospective effective connectivity approach for understanding adolescent changes in alcohol-related neural processes. Copyright © 2013 Elsevier Ltd. All rights reserved.

An exploratory pilot study to design and assess the credibility of a sham kinesiology treatment.

PubMed

Hall, Sue; Lewith, George; Brien, Sarah; Little, Paul

2008-12-01

Kinesiology is a complementary therapy assessing subtle change in manual muscle testing results to select individualised treatments. We report the exploratory 2-stage development and pilot of a sham kinesiology treatment for use in a clinical trial to evaluate the specific effects of this intervention. 1. To design, pilot and assess the credibility of a sham kinesiology treatment in a kinesiology-aware population. 2. To pilot the sham kinesiology in a cross-over study of sham versus real kinesiology, and to make an exploratory assessment of its credibility in a kinesiology-naïve population. 1. 10 kinesiology-aware volunteers received a specially designed sham treatment weekly for 5 weeks which was subject to a credibility assessment. 2. 10 kinesiology-naïve patients with low back pain were randomised to receive 4 real and 4 sham treatments in a cross-over design; the treatments were subject to a credibility assessment. 100% of participants found the sham protocol a credible treatment as measured by the credibility questionnaire. 100% of patients having real treatment first did not recognise that the second set of treatments were sham. Small numbers precluded the use of formal statistical tests. In this small sample it appeared feasible to deliver an apparently credible sham kinesiology treatment. This feasibility study has allowed us to develop a sham treatment for use in a larger prospective clinical trial of kinesiology in patients with low back pain. 2008 S. Karger AG, Basel.

Prospective Assessment of Nocturnal Awakenings in a Case Series of Treatment-Seeking Chronic Insomnia Patients: A Pilot Study of Subjective and Objective Causes

PubMed Central

Krakow, Barry; Romero, Edward; Ulibarri, Victor A.; Kikta, Shara

2012-01-01

Background: The cause of nocturnal awakenings in patients with chronic insomnia is rarely researched. This study prospectively assessed the etiology of nocturnal awakenings (subjectively and objectively) among patients with insomnia at a private, community-based sleep medical center. Methods: Twenty adult patients with chronic insomnia enrolled between April 2008 and February 2010 met diagnostic criteria for an insomnia disorder, never previously visited a sleep specialist or underwent sleep testing, and reported no classic sleep disordered breathing symptoms. Patients completed validated scales for insomnia, sleepiness, impairment, anxiety, depression, and quality of life, a qualitative interview to assess subjective reasons for awakenings, and a diagnostic sleep study to objectively assess awakenings and their precipitants. Results: Subjective and objective data showed clinically meaningful insomnia, primarily sleep maintenance insomnia. The most common self-reported reasons for awakenings were: uncertain cause (50%), nightmares (45%), nocturia (35%), bedroom distractions (20%), or pain (15%). No patient identified breathing symptoms as a cause. Objectively, 531 awakenings were observed in the total sample, and 478 (90%) were preceded by sleep breathing events (apnea, hypopnea, or respiratory effort-related event). Fifty-three awakenings were caused by other factors (independent leg jerks [7], spontaneous [14], and sleep that was laboratory-induced [32]). Thirty awakenings ≥ 5 min—a duration sufficient to predispose toward an insomnia episode—were each preceded by a breathing event. Conclusions: Among patients with insomnia with no classic sleep breathing symptoms and therefore low probability of a sleep breathing disorder, most of their awakenings were precipitated by a medical condition (sleep disordered breathing), which contrasted sharply with their perceptions about their awakenings. Citation: Krakow B; Romero E; Ulibarri VA; Kikta S. Prospective assessment of nocturnal awakenings in a case series of treatment-seeking chronic insomnia patients: a pilot study of subjective and objective causes. SLEEP 2012;35(12):1685-1692. PMID:23204611

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

PubMed Central

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

2015-01-01

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

Prospective, open-label, uncontrolled pilot study to study safety and efficacy of sildenafil in systemic sclerosis-related pulmonary artery hypertension and cutaneous vascular complications.

PubMed

Kumar, Uma; Sankalp, Gokhale; Gokhle, Sankalp S; Sreenivas, V; Kaur, Satbir; Misra, Durgaprasanna

2013-04-01

Pulmonary artery hypertension (PAH) remains the leading cause of morbidity and mortality in systemic sclerosis, while Raynaud's phenomenon and digital ulcers significantly add to the morbidity in systemic sclerosis (SSc). This study was undertaken to evaluate the role of sildenafil in PAH, Raynaud's phenomenon, and digital ulcers in systemic sclerosis patients. A prospective, open-label, uncontrolled pilot study was done at a tertiary care centre in India to study the safety and efficacy of oral sildenafil in PAH, Raynaud's phenomenon, digital infarcts, and ulcers in SSc. Seventeen patients fulfilling ACR classification criteria for scleroderma and having PAH were recruited. Six-minute walk test, WHO class of dyspnoea, severity of Raynaud's phenomenon, and 2D ECHO were performed in all the study subjects at baseline and at 3 months post-treatment. All patients were treated with oral sildenafil 25 mg three times a day for a period of 3 months. The pre- and post-treatment values of mean pulmonary artery pressure (PAP), 6-min walk test, WHO class of dyspnoea, and severity of Raynaud's phenomenon were compared to look for any significant change. Sixteen patients who completed 3-month follow-up had shown statistically significant improvement in 6-min walk test, WHO class of dyspnoea, severity of Raynaud's phenomenon, and mPAP. Also, there was no occurrence of new digital infarcts or ulcers, and existing ulcers showed signs of healing. Sildenafil is highly efficacious cheaper and safe alternative to other available therapies for SSc-associated PAH, Raynaud's phenomenon, and digital infarcts/ulcers.

Feature-level analysis of a novel smartphone application for smoking cessation.

PubMed

Heffner, Jaimee L; Vilardaga, Roger; Mercer, Laina D; Kientz, Julie A; Bricker, Jonathan B

2015-01-01

Currently, there are over 400 smoking cessation smartphone apps available, downloaded an estimated 780,000 times per month. No prior studies have examined how individuals engage with specific features of cessation apps and whether use of these features is associated with quitting. Using data from a pilot trial of a novel smoking cessation app, we examined: (i) the 10 most-used app features, and (ii) prospective associations between feature usage and quitting. Participants (n = 76) were from the experimental arm of a randomized, controlled pilot trial of an app for smoking cessation called "SmartQuit," which includes elements of both Acceptance and Commitment Therapy (ACT) and traditional cognitive behavioral therapy (CBT). Utilization data were automatically tracked during the 8-week treatment phase. Thirty-day point prevalence smoking abstinence was assessed at 60-day follow-up. The most-used features - quit plan, tracking, progress, and sharing - were mostly CBT. Only two of the 10 most-used features were prospectively associated with quitting: viewing the quit plan (p = 0.03) and tracking practice of letting urges pass (p = 0.03). Tracking ACT skill practice was used by fewer participants (n = 43) but was associated with cessation (p = 0.01). In this exploratory analysis without control for multiple comparisons, viewing a quit plan (CBT) as well as tracking practice of letting urges pass (ACT) were both appealing to app users and associated with successful quitting. Aside from these features, there was little overlap between a feature's popularity and its prospective association with quitting. Tests of causal associations between feature usage and smoking cessation are now needed.

Concomitant weekly cisplatin and thoracic radiotherapy for Pancoast tumors of the lung: pilot experience of the San Antonio Cancer Institute.

PubMed

Barnes, Jonathan B; Johnson, Scott B; Dahiya, Rajiv S; Temes, R Thomas; Herman, Terence S; Thomas, Charles R

2002-02-01

Pancoast (superior sulcus tumors) comprise a subset of non-small-cell lung cancers that have a unique clinical presentation by virtue of the locoregional pattern of disease progression. We herein report a brief report on our group's pilot experience in managing these challenging lung neoplasms with an aggressive concomitant modality approach. These results and those of the recent Southwest Oncology-lead Intergroup prospective phase 2 trial (SWOG-9416/INT-0160) support the use of concomitant chemoradiation followed by an attempt at surgical resection.

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

PubMed

Johnstone, Jennie; Meade, Maureen; Marshall, John; Heyland, Daren K; Surette, Michael G; Bowdish, Dawn Me; Lauzier, Francois; Thebane, Lehana; Cook, Deborah J

2015-01-01

Probiotics are defined as live microorganisms that may confer health benefits when ingested. Meta-analysis of probiotic trials suggests a 25 % lower ventilator-associated pneumonia (VAP) and 18 % lower infection rates overall when administered to patients in the intensive care unit (ICU). However, prior trials are small, largely single center, and at high risk of bias. Before a large rigorous trial is launched, testing whether probiotics confer benefit, harm, or have no impact, a pilot trial is needed. The aim of the PROSPECT Pilot Trial is to determine the feasibility of performing a larger trial in mechanically ventilated critically ill patients investigating Lactobacillus rhamnosus GG. A priori, we determined that the feasibility of the larger trial would be based on timely recruitment, high protocol adherence, minimal contamination, and an acceptable VAP rate. Patients ≥18 years old in the ICU who are anticipated to receive mechanical ventilation for ≥72 hours will be included. Patients are excluded if they are at increased risk of probiotic-associated infection, have strict enteral medication contraindications, are pregnant, previously enrolled in a related trial, or are receiving palliative care. Following informed consent, patients are randomized in variable unspecified block sizes in a fixed 1:1 ratio, stratified by ICU, and medical, surgical, or trauma admitting diagnosis. Patients receive 1 × 10 10 colony forming units of L. rhamnosus GG (Culturelle, Locin Industries Ltd) or an identical placebo suspended in tap water administered twice daily via nasogastric tube in the ICU. Clinical and research staff, patients, and families are blinded. The primary outcomes for this pilot trial are the following: (1) recruitment success, (2) ≥90 % protocol adherence, (3) ≤5 % contamination, and (4) ~10 % VAP rate. Additional clinical outcomes are VAP, other infections, diarrhea (total, antibiotic associated, and Clostridium difficile), ICU and hospital length of stay, and mortality. The morbidity, mortality, and cost of VAP underscore the need for cost-effective prophylactic interventions. The PROSPECT Pilot Trial is the initial step toward rigorously evaluating whether probiotics decrease nosocomial infections, have no effect, or actually cause infections in critically ill patients. ClinicalTrials.gov. NCT01782755.

Innovative Technology Using Virtual Reality in the Treatment of Pain: Does It Reduce Pain via Distraction, or Is There More to It?

PubMed

Gupta, Anita; Scott, Kevin; Dukewich, Matthew

2018-01-01

Virtual reality (VR) is an exciting new technology with almost endless possible uses in medicine. One area it has shown promise is pain management. This selective review focused on studies that gave evidence to the distraction or nondistraction mechanisms by which VR leads to the treatment of pain. The review looked at articles from 2000 to July 29, 2016, focusing on studies concerning mechanisms by which virtual reality can augment pain relief. The data was collected through a search of MEDLINE and Web of Science using the key words of "virtual reality" and "pain" or "distraction." Six studies were identified: four small randomized controlled studies and two prospective/pilot studies. The search results provided evidence that distraction is a technique by which VR can have benefits in the treatment of pain. Both adult and pediatric populations were included in these studies. In addition to acute pain, several studies looked at chronic pain states such as headaches or fibromyalgia. These studies also combined VR with other treatment modalities such as biofeedback mechanisms and cognitive behavioral therapy. These results demonstrate that in addition to distraction, there are novel mechanisms for VR treatment in pain, such as producing neurophysiologic changes related to conditioning and exposure therapies. If these new mechanisms can lead to new treatment options for patients with chronic pain, VR may have the ability to help reduce opioid use and misuse among chronic pain patients. More studies are needed to reproduce results from prospective/pilot studies in large randomized control studies. © 2017 American Academy of Pain Medicine. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com

Learning by heart-the relationship between resting vagal tone and metacognitive judgments: a pilot study.

PubMed

Meessen, Judith; Sütterlin, Stefan; Gauggel, Siegfried; Forkmann, Thomas

2018-05-23

Metacognitive awareness and resting vagally mediated heart rate variability (HRV) as a physiological trait marker of cognitive inhibitory control capacities are both associated with better well-being and seem to share a common neural basis. Executive functioning which is considered a prerequisite for delivering prospective metacognitive judgments has been found to be correlated with HRV. This pilot study addresses the question, whether metacognitive awareness and resting vagally mediated HRV are positively associated. A sample of 20 healthy participants was analyzed that completed a typical Judgment of Learning task after an electrocardiogram had been recorded. The root-mean-squares of successive differences were used to calculate vagally mediated HRV. Metacognitive awareness was measured by comparing the judgments of learning with the actual memory performance, yielding a deviation score. HRV was found to be positively correlated with metacognitive awareness. Results suggest that metacognitive abilities might relate to physiological trait markers of cognitive inhibitory control capacities. Further experimental studies are needed to investigate causal relations.

A Pilot Study of Reasons and Risk Factors for "No-Shows" in a Pediatric Neurology Clinic.

PubMed

Guzek, Lindsay M; Fadel, William F; Golomb, Meredith R

2015-09-01

Missed clinic appointments lead to decreased patient access, worse patient outcomes, and increased healthcare costs. The goal of this pilot study was to identify reasons for and risk factors associated with missed pediatric neurology outpatient appointments ("no-shows"). This was a prospective cohort study of patients scheduled for 1 week of clinic. Data on patient clinical and demographic information were collected by record review; data on reasons for missed appointments were collected by phone interviews. Univariate and multivariate analyses were conducted using chi-square tests and multiple logistic regression to assess risk factors for missed appointments. Fifty-nine (25%) of 236 scheduled patients were no-shows. Scheduling conflicts (25.9%) and forgetting (20.4%) were the most common reasons for missed appointments. When controlling for confounding factors in the logistic regression, Medicaid (odds ratio 2.36), distance from clinic, and time since appointment was scheduled were associated with missed appointments. Further work in this area is needed. © The Author(s) 2014.

Future research: a prospective longitudinal study of elder self-neglect.

PubMed

Dyer, Carmel Bitondo; Franzini, Luisa; Watson, Mary; Sanchez, Luis; Prati, Laura; Mitchell, Stacy; Wallace, Robert; Pickens, Sabrina

2008-11-01

In almost every U.S. jurisdiction, elder self-neglect is the most common allegation addressed by Adult Protective Service (APS) agencies. Not only is self-neglect common, but this form of mistreatment is an independent risk factor for death. A lack of understanding of the precipitating factors and root causes and of the effect on social and medical systems persists in this field. Research in this area has been limited, because the needs of these vulnerable elderly people are complex and diverse. Moreover, these factors encompass interrelated medical, psychiatric, economic, social, and functional problems. In 2004, the National Institutes of Health Interdisciplinary Roadmap Initiative provided the means for preliminary exploration of elder self-neglect through the formation of the Consortium for Research in Elder Self-neglect of Texas (CREST). The goals of CREST include to conduct pilot studies, form interdisciplinary working groups, convene a national research conference, and appoint a national external advisory board. CREST orchestrated the work of 35 interdisciplinary investigators to achieve these goals. CREST researchers have begun to characterize the population of vulnerable elderly people who were reported to APS for neglecting themselves. The pilot studies provided a snapshot of 100 elderly people who had neglected themselves. A proposed next phase could involve a prospective longitudinal study of elderly people with severe self-neglect. This study of the clinical course, the death rate, the causes of death, the occurrence of acute and chronic medical or mental illness, and the costs to the healthcare and social systems would greatly inform the field of elder mistreatment.

A prospective pilot study of Dilapan-S compared with Propess for induction of labour at 41+ weeks in nulliparous pregnancy.

PubMed

Crosby, David A; O'Reilly, Claire; McHale, Helen; McAuliffe, Fionnuala M; Mahony, Rhona

2017-12-21

The incidence of labour induction has risen worldwide over the past decade, and this may contribute to the rising caesarean delivery rate. The mechanisms for induction of labour are generally divided into two categories: mechanical and pharmacological. The objective of this study was to determine if mechanical induction with Dilapan-S is an acceptable, safe method of induction of labour in post-dates uncomplicated nulliparous pregnancy. This was a single-centre prospective observational pilot study trial. Fifty-two low-risk nulliparous women with an unfavourable cervix, scheduled for induction of labour for post-dates ≥ 41 weeks gestation, were offered induction of labour with Dilapan-S or Propess from May 2016 until November 2016. The primary outcomes measured were compliance to study protocol and maternal (infection, hyperstimulation) and neonatal outcomes (Apgar score at birth). The secondary outcome measures included change in Bishop's score and caesarean delivery rate. Compliance to study protocol was 25/26 (96%); it was possible to insert Dilapan-S in all but one woman. There were no differences in maternal and neonatal primary outcomes between the groups. There were no cases in either arm of hyperstimulation with either induction method. No difference between the groups was noted in the caesarean delivery rate nor in the mean change in Bishop's score. Dilapan-S is an acceptable, safe form of induction of labour in post-dates uncomplicated nulliparous pregnancy. No cases of hyperstimulation were found, and therefore, Dilapan-S may be a suitable option for outpatient induction of labour in low-risk post-dates nulliparas.

A Pilot Study of CPAP Adherence Promotion by Peer Buddies with Sleep Apnea

PubMed Central

Parthasarathy, Sairam; Wendel, Christopher; Haynes, Patricia L.; Atwood, Charles; Kuna, Samuel

2013-01-01

Study Objectives: To evaluate patient ratings of the acceptability of a peer buddy system (PBS). To promote continuous positive airway pressure (CPAP) therapy adherence in patients with obstructive sleep apnea (OSA). To obtain preliminary data on the effectiveness of PBS on sleep-specific health-related quality of life and CPAP adherence. Design: Prospective, randomized, and controlled study. Setting: Academic Center. Participants: Thirty-nine patients with OSA and 13 patients with OSA who were experienced CPAP users. Interventions: Recently diagnosed patients with OSA were randomly assigned to either the PBS to promote CPAP adherence (intervention group) or usual care (control group). Measurements: Patient satisfaction, Functional Outcomes of Sleep Questionnaire (FOSQ), CPAP adherence, vigilance, self-efficacy, and patient activation were measured. Results: Ninety-one percent of the subjects rated the PBS as very satisfactory (68%) or satisfactory (23%). During the 90 days of therapy, weekly CPAP adherence was greater in the intervention than the usual care group (MANOVA; F = 2.29; p = 0.04). Patient satisfaction was positively correlated with CPAP adherence (R2 = 0.14; p = 0.02). We did not find any group differences for FOSQ, vigilance, self-efficacy, or patient activation in this pilot study. Conclusion: Our pilot study suggests that the PBS intervention is feasible and received high patient satisfaction ratings. CPAP adherence may be improved by peer-driven intervention, but a larger, adequately powered study is needed. Clinical Trial Information: ClinicalTrials.gov identifier: NCT01164683. Commentary: A commentary on this article appears in this issue on page 551. Citation: Parthasarathy S; Wendel C; Haynes PL; Atwood C; Kuna S. A pilot study of CPAP adherence promotion by peer buddies with sleep apnea. J Clin Sleep Med 2013;9(6):543-550. PMID:23772186

A Prospective, Randomized, Double-Blinded, Double-Dummy Pilot Study to Assess the Preemptive Effect of Triple Therapy with Aprepitant, Dexamethasone, and Promethazine versus Ondansetron, Dexamethasone and Promethazine on Reducing the Incidence of Postoperative Nausea and Vomiting Experienced by Patients Undergoing Craniotomy Under General Anesthesia.

PubMed

Bergese, Sergio Daniel; Puente, Erika G; Antor, Maria A; Viloria, Adolfo L; Yildiz, Vedat; Kumar, Nicolas Alexander; Uribe, Alberto A

2016-01-01

Postoperative nausea and vomiting (PONV) is among the most common distressing complications of surgery under anesthesia. Previous studies have demonstrated that patients who undergo craniotomy have incidences of nausea and vomiting as high as 50-70%. The main purpose of this pilot study is to assess the incidence of PONV by using two different prophylactic regimens in subjects undergoing a craniotomy. Thus, we designed this study to assess the efficacy and safety of triple therapy with the combination of dexamethasone, promethazine, and aprepitant versus ondansetron to reduce the incidence of PONV in patients undergoing craniotomy. This is a prospective, single center, two-armed, randomized, double-dummy, double-blind, pilot study. Subjects were randomly assigned to one of the two treatment groups. Subjects received 40 mg of aprepitant pill (or matching placebo pill) 30-60 min before induction of anesthesia and 4 mg of ondansetron IV (or 2 ml of placebo saline solution) at induction of anesthesia. In addition, all subjects received 25 mg of promethazine IV and 10 mg of dexamethasone IV at induction of anesthesia. Assessments of PONV commenced for the first 24 h after surgery and were subsequently assessed for up to 5 days. The overall incidence of PONV during the first 24 h after surgery was 31.0% (n = 15) in the aprepitant group and 36.2% (n = 17) for the ondansetron group. The median times to first emetic and significant nausea episodes were 7.6 (2.9, 48.7) and 14.3 (4.4, 30.7) hours, respectively, for the aprepitant group and 6.0 (2.2, 29.5) and 9.6 (0.7, 35.2) hours, respectively, for the ondansetron group. There were no statistically significant differences between these groups. No adverse events directly related to study medications were found. This pilot study showed similar effectiveness when comparing the two PONV prophylaxis regimens. Our data showed that both treatments could be effective regimens to prevent PONV in patients undergoing craniotomy under general anesthesia. Future trials testing new PONV prophylaxis regimens in this surgical population should be performed to gain a better understanding of how to best provide prophylactic treatment.

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

Samet, J.; Gilliland, F.D.

This project incorporates two related research projects directed toward understanding respiratory carcinogenesis in radon-exposed former uranium miners. The first project involved a continuation of the tissue resource of lung cancer cases from former underground uranium miners and comparison cases from non-miners. The second project was a pilot study for a proposed longitudinal study of respiratory carcinogenesis in former uranium miners. The objectives including facilitating the investigation of molecular changes in radon exposed lung cancer cases, developing methods for prospectively studying clinical, cytologic, cytogenetic, and molecular changes in the multi-event process of respiratory carcinogenesis, and assessing the feasibility of recruiting formermore » uranium miners into a longitudinal study that collected multiple biological specimens. A pilot study was conducted to determine whether blood collection, induced sputum, bronchial brushing, washings, and mucosal biopsies from participants at two of the hospitals could be included efficiently. A questionnaire was developed for the extended study and all protocols for specimen collection and tissue handling were completed. Resource utilization is in progress at ITRI and the methods have been developed to study molecular and cellular changes in exfoliated cells contained in sputum as well as susceptibility factors.« less

Prospective Assessment of Neurocognition in Future Gulf-Deployed and Gulf-Nondeployed Military Personnel: A Pilot Study

DTIC Science & Technology

2008-02-01

CW, Castro CA, Messer SC, McGurk D, Cotting DI, Koffman RL : Combat duty in Iraq and Afghanistan: mental health problems and barriers to care. N Eng...JA, Hough RL , Jordan BK, Marmar CR, et al. Trauma and the Vietnam war generation: Report of findings from the National Vietnam Veterans Readjustment...Castro CA, Messer SC, McGurk D, Cotting DI, Koffman RL . Combat duty in Iraq and Afghanistan, mental health problems, and barriers to care. N Engl J Med

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

PubMed

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

2016-08-02

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

Specific exercise training for reducing neck and shoulder pain among military helicopter pilots and crew members: a randomized controlled trial protocol.

PubMed

Murray, Mike; Lange, Britt; Nørnberg, Bo Riebeling; Søgaard, Karen; Sjøgaard, Gisela

2015-08-19

Flight-related neck/shoulder pain is frequent among military helicopter pilots and crew members. With a lifetime prevalence of 81% for pilots and 84% for crew members, the prevalence of neck pain is considered high compared to the general population. The aim of this study was to investigate whether a specifically tailored exercise intervention would reduce the prevalence and incidence rate of neck/shoulder pain among helicopter pilots and crew members. This study used a prospective, parallel group, single blinded, randomized controlled design. Participants were military helicopter pilots and crew members recruited from the Royal Danish Air Force. Inclusion criteria were: 1) employed within the Royal Danish Air Force as a helicopter pilot or onboard crew member (technician, systems-operator, tactical helicopter observer and/or navigator), 2) maintaining operational flight status at enrollment, and 3) operational flying within the previous 6 months. Primary outcome was change in neck and shoulder pain assessed by 1) a modified version of the "Standardized Nordic questionnaire for the analysis of musculoskeletal symptoms" and by 2) pressure pain threshold measurements. Secondary outcomes included: postural balance, strength, stability, and rate of force development for neck and shoulder muscles. Measurements at baseline and follow-up were conducted at four air force bases in Denmark. Sixty-nine participants were individually randomized to either a training group (TG) or a reference group (RG). Participants in the TG performed 20-weeks of physical exercise training divided into sessions of 3 × 20 min per week. Training was completed within working hours and consisted of specific exercise training for the neck and shoulder muscles based on the principles of "Intelligent Physical Exercise Training". The RG received no training. In spite of the high prevalence of flight related neck/shoulder pain among military helicopter pilots and crew members there are currently no evidence based guidelines for the prevention or clinical handling of neck pain among these occupational groups. Results from this study may therefore be beneficial for future establishment of such guidelines. Ethical committee of Southern Denmark (S-20120121) 29 August, 2012. Clinical Trail Registration (NCT01926262) 16 August, 2013.

A comparison of Kneipp hydrotherapy with conventional physiotherapy in the treatment of osteoarthritis: a pilot trial.

PubMed

Schencking, Martin; Wilm, Stefan; Redaelli, Marcus

2013-01-01

An increasingly aging population implies an increasing prevalence of osteoarthritis (OA) of hip or knee. It has been ascertained that unspecific hydrotherapy of OA according to Sebastian Kneipp not only improves the range of mobility but also reduces pain significantly and increases the quality of life of the patients affected. The main aim of this pilot study was to determine the effects of hydrotherapy in comparison to conventional physiotherapy, and to analyze the feasibility of the study design under clinical circumstances. The study design is a prospective randomized controlled three-arm clinical pilot trial, carried out at a specialist clinic for integrative medicine. Thirty patients diagnosed with symptomatic OA of hip or knee and radiologic findings were randomly assigned to one of two intervention groups and a control group: hydrotherapy (group 1), physiotherapy (group 2), and both physiotherapy and hydrotherapy (group 3, control group) of the affected joint. pain intensity of the affected joint in the course of inpatient treatment; secondary outcome: health-related quality of life, joint-specific pain and mobility in the course of the study. Concerning the main outcome, intervention group 1 showed most beneficial effects in the course of inpatient treatment, followed by groups 3 and 2, and also the indirect flexion ability of hip or knee together with the general patient mobility through the "timed up and go" test were mainly improved within group 1 followed by groups 3 and 2. The results of this pilot study demonstrate beneficial effects of hydrotherapy. The study design is feasible. For statistically significant evidence and a robust conclusion of efficacy of Kneipp's hydrotherapy, a larger sample size is necessary. NCT 00950326.

Valganciclovir (VGCV) followed by cytomegalovirus (CMV) hyperimmune globulin compared to VGCV for 200 days in abdominal organ transplant recipients at high risk for CMV infection: A prospective, randomized pilot study.

PubMed

Fleming, James N; Taber, David J; Weimert, Nicole A; Nadig, Satish; McGillicuddy, John W; Bratton, Charles F; Baliga, Prabhakar K; Chavin, Kenneth D

2017-12-01

With the advent of effective antivirals against cytomegalovirus (CMV), use of CMV hyperimmune globulin (HIG) has decreased. Although antiviral prophylaxis in patients at high risk for CMV is effective, many patients still have late infection, never developing antibodies sufficient to achieve immunity. Utilizing a combination of antiviral and CMV HIG may allow patients to achieve immunity and decrease late CMV infections. This was a prospective randomized, open-label, pilot study comparing valganciclovir (VGCV) prophylaxis for 200 days vs VGCV for 100 days followed by CMV HIG in abdominal transplant recipients at high risk for CMV. The primary outcome was a comparison of late CMV disease. Forty patients were randomized to VGCV for 200 days (n = 20) or VGCV for 100 days followed by 3 doses of monthly CMV HIG (n = 20). Numerically, more overall CMV infections occurred in the CMV HIG group (45 vs 20%, P = .09). No differences in overall CMV infections or late CMV disease were seen between groups (20% vs 15%, P = 1.00 and 0 vs 0, P = 1.00). All CMV disease occurred within 200 days, with 63% occurring while patients were on VGCV. No differences were found in toxicities, graft function, or rejection between groups. Patients with CMV infection at any time had a higher body weight than those who did not have an infection (82 vs 95 kg, P = .049). Use of CMV HIG sequentially with prophylaxis may be an effective and affordable prophylactic regimen in abdominal transplant recipients at high risk for CMV, and warrants larger prospective study. Increased monitoring for patients with obesity may be warranted. © 2017 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

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

PubMed

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

2015-05-01

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

Oxygen Mask Related Nasal Integument and Osteocartilagenous Disorders in F-16 Fighter Pilots

PubMed Central

Schreinemakers, J. Rieneke C.; Westers, Paul; van Amerongen, Pieter; Kon, Moshe

2013-01-01

Background A preliminary survey showed half of the participating Royal Netherlands Air Force (RNLAF) F-16 fighter pilots to have nasal integument and osteocartilagenous disorders related to wearing in-flight oxygen masks. Aim To make an inventory of these disorders and possible associated factors. Methods All RNLAF F-16 pilots were requested to fill out a semi-structured questionnaire for a cross-sectional survey. Additionally, one squadron in The Netherlands and pilots in operational theater were asked to participate in a prospective study that required filling out a pain score after each flight. Pilot- and flight-related variables on all participants were collected from the RNLAF database. A linear mixed model was built to identify associated factors with the post-flight pain score. Results The response rate to the survey was 83%. Ninety of the 108 participants (88%, 6 missing) reported tenderness, irritation, pain, erythema, skin lesions, callous skin, or swelling of nasal bridge integument or architecture. Seventy-two participants (71%, 6 missing) reported their symptoms to be troublesome after a mean of 6±3 out of 10 flights (0;10, 54 missing). Sixty-six pilots participated in scoring post-flight pain. Pain scores were significantly higher if a participant had ≥3 nasal disorders, after longer than average flights, after flying abroad, and after flying with night vision goggles (respectively +2.7 points, p = 0.003; +0.2 points, p = 0.027; +1.8 points, p = 0.001; +1.2 points p = 0.005). Longer than average NVG flights and more than average NVG hours per annum decreased painscores (respectively −0.8 points, p = 0.017; −0.04 points, p = 0.005). Conclusions The majority of the RNLAF F-16 fighter pilot community has nasal disorders in the contact area of the oxygen mask, including pain. Six pilot- or flight-related characteristics influence the experienced level of pain. PMID:23505413

Oxygen mask related nasal integument and osteocartilagenous disorders in F-16 fighter pilots.

PubMed

Schreinemakers, J Rieneke C; Westers, Paul; van Amerongen, Pieter; Kon, Moshe

2013-01-01

A preliminary survey showed half of the participating Royal Netherlands Air Force (RNLAF) F-16 fighter pilots to have nasal integument and osteocartilagenous disorders related to wearing in-flight oxygen masks. To make an inventory of these disorders and possible associated factors. All RNLAF F-16 pilots were requested to fill out a semi-structured questionnaire for a cross-sectional survey. Additionally, one squadron in The Netherlands and pilots in operational theater were asked to participate in a prospective study that required filling out a pain score after each flight. Pilot- and flight-related variables on all participants were collected from the RNLAF database. A linear mixed model was built to identify associated factors with the post-flight pain score. The response rate to the survey was 83%. Ninety of the 108 participants (88%, 6 missing) reported tenderness, irritation, pain, erythema, skin lesions, callous skin, or swelling of nasal bridge integument or architecture. Seventy-two participants (71%, 6 missing) reported their symptoms to be troublesome after a mean of 6±3 out of 10 flights (0;10, 54 missing). Sixty-six pilots participated in scoring post-flight pain. Pain scores were significantly higher if a participant had ≥3 nasal disorders, after longer than average flights, after flying abroad, and after flying with night vision goggles (respectively +2.7 points, p = 0.003; +0.2 points, p = 0.027; +1.8 points, p = 0.001; +1.2 points p = 0.005). Longer than average NVG flights and more than average NVG hours per annum decreased painscores (respectively -0.8 points, p = 0.017; -0.04 points, p = 0.005). The majority of the RNLAF F-16 fighter pilot community has nasal disorders in the contact area of the oxygen mask, including pain. Six pilot- or flight-related characteristics influence the experienced level of pain.

Impact of Medical Scribes on Physician and Patient Satisfaction in Primary Care.

PubMed

Pozdnyakova, Anastasia; Laiteerapong, Neda; Volerman, Anna; Feld, Lauren D; Wan, Wen; Burnet, Deborah L; Lee, Wei Wei

2018-04-26

Use of electronic health records (EHRs) is associated with physician stress and burnout. While emergency departments and subspecialists have used scribes to address this issue, little is known about the impact of scribes in academic primary care. Assess the impact of a scribe on physician and patient satisfaction at an academic general internal medicine (GIM) clinic. Prospective, pre-post-pilot study. During the 3-month pilot, physicians had clinic sessions with and without a scribe. We assessed changes in (1) physician workplace satisfaction and burnout, (2) time spent on EHR documentation, and (3) patient satisfaction. Six GIM faculty and a convenience sample of their patients (N = 325) at an academic GIM clinic. A 21-item pre- and 44-item post-pilot survey assessed physician workplace satisfaction and burnout. Physicians used logs to record time spent on EHR documentation outside of clinic hours. A 27-item post-visit survey assessed patient satisfaction during visits with and without the scribe. Of six physicians, 100% were satisfied with clinic workflow post-pilot (vs. 33% pre-pilot), and 83% were satisfied with EHR use post-pilot (vs. 17% pre-pilot). Physician burnout was low at baseline and did not change post-pilot. Mean time spent on post-clinic EHR documentation decreased from 1.65 to 0.76 h per clinic session (p = 0.02). Patient satisfaction was not different between patients who had clinic visits with vs. without scribe overall or by age, gender, and race. Compared to patients 65 years or older, younger patients were more likely to report that the physician was more attentive and provided more education during visits with the scribe present (p = 0.03 and 0.02, respectively). Male patients were more likely to report that they disliked having a scribe (p = 0.03). In an academic GIM setting, employment of a scribe was associated with improved physician satisfaction without compromising patient satisfaction.

Impact of fumaric acid esters on cardiovascular risk factors and depression in psoriasis: a prospective pilot study.

PubMed

Schmieder, Astrid; Poppe, Manuel; Hametner, Christian; Meyer-Schraml, Hanna; Schaarschmidt, Marthe-Lisa; Findeisen, Peter; Benoit, Sandrine; Bauer, Boris; Schmid, Sybille; Goebeler, Matthias; Goerdt, Sergij; Ludwig-Peitsch, Wiebke K

2015-07-01

Patients with psoriasis have an increased risk of cardiovascular disease that is partly attributable to chronic systemic inflammation. The aim of our prospective pilot study was to investigate the impact of fumaric acid esters (FAE), a first-line systemic antipsoriatic treatment in Germany, on cardiovascular risk parameters. Participants with moderate-to-severe psoriasis from the University Medical Center Mannheim and the University Hospital Würzburg were treated with FAE for 16 weeks according to standard dosage recommendations. Disease severity, life quality and depression scores as well as biomarkers of inflammation, lipid and glucose metabolism were assessed prior to initiation of FAE and after 16 weeks. Out of 39 participants recruited, 27 completed the study. 44% of all participants and 63% of those completing the 16-week treatment achieved PASI 50 response and 27 or 37% PASI 75 response. Clinical improvement was paralleled by significant improvement in quality of life, high treatment satisfaction and significant reduction of depressive symptoms. Adverse events, most frequently mild gastrointestinal complaints, flush and lymphocytopenia occurred in 89%. FAE did not modify glucose metabolism or inflammatory parameters substantially. However, a highly significant increase in serum levels of the atheroprotective cytokine adiponectin was noted after 16 weeks (median 4.7 vs. 8.9 µg/ml; p = 0.0002). Our study demonstrates a significant beneficial impact of FAE on adiponectin, indicating a potential cardioprotective effect. It will be interesting to verify this finding in larger cohorts and to assess the long-term influence of FAE on cardiovascular risk and disease.

Effects of sleep bruxism on functional and occlusal parameters: a prospective controlled investigation

PubMed Central

Alicia Ommerborn, Michelle; Giraki, Maria; Schneider, Christine; Michael Fuck, Lars; Handschel, Jörg; Franz, Matthias; Hans-Michael Raab, Wolfgang; Schäfer, Ralf

2012-01-01

This study was conducted to verify the results of a preceding retrospective pilot study by means of a prospective controlled investigation including a larger sample size. Therefore, the aim of this clinical investigation was to analyze the relationship between sleep bruxism and several functional and occlusal parameters. The null hypothesis of this study was that there would be no differences among sleep bruxism subjects and non-sleep bruxism controls regarding several functional and occlusal parameters. Fifty-eight sleep bruxism subjects and 31 controls participated in this study. The diagnosis sleep bruxism was based on clinical criteria of the American Academy of Sleep Medicine. Sixteen functional and occlusal parameters were recorded clinically or from dental study casts. Similar to the recently published retrospective pilot study, with a mean slide of 0.77 mm (s.d., 0.69 mm) in the sleep bruxism group and a mean slide of 0.4 mm (s.d., 0.57 mm) in the control group, the evaluation of the mean comparison between the two groups demonstrated a larger slide from centric occlusion to maximum intercuspation in sleep bruxism subjects (Mann–Whitney U-test; P=0.008). However, following Bonferroni adjustment, none of the 16 occlusal and functional variables differed significantly between the sleep bruxism subjects and the non-sleep bruxism controls. The present study shows that the occlusal and functional parameters evaluated do not differ between sleep bruxism subjects and non-sleep bruxism subjects. However, as the literature reveals a possible association between bruxism and certain subgroups of temporomandibular disorders, it appears advisable to incorporate the individual adaptive capacity of the stomatognathic system into future investigations. PMID:22935746

Switch of noninvasive ventilation (NIV) to continuous positive airway pressure (CPAP) in patients with obesity hypoventilation syndrome: a pilot study.

PubMed

Orfanos, Sarah; Jaffuel, Dany; Perrin, Christophe; Molinari, Nicolas; Chanez, Pascal; Palot, Alain

2017-03-14

Obesity is a major worldwide public health issue. The main respiratory complication stemming from obesity is obesity hypoventilation syndrome (OHS). Most of the OHS patients diagnosed during an exacerbation are treated with non invasive ventilation (NIV). Up to date, no prospective study has demonstrated in real life conditions the feasibility of a systematic protocoled switch of NIV to continuous positive airway pressure (CPAP), once stability is achieved. In this prospective study, we included stable patients with OHS, with moderate to severe concomitant obstructive sleep apnea (OSA) and without obstructive pulmonary disease, who had been undergoing NIV for more than 2 months. The following measurements were performed, first with NIV and then after the switch to CPAP: diurnal arterial blood gas measurements; nocturnal oximetry and capnometry; mean compliance and AHI; measures of quality of life and quality of sleep. 22/30 patients accepted to participate in the study and 15/22 patients completed the study. There were no significant differences for pooled data in diurnal alveolar blood gases, nocturnal capnometry (p = 0.534), nocturnal oximetry (p = 0.218), mean compliance (p = 0.766), mean AHI (p = 0.334), quality of life or quality of sleep. Eighty percent of the patients treated in this study favored CPAP over NIV. This pilot study showed in real life conditions the possibility of a systematic switch of NIV to CPAP, in most stable patients with OHS, with similar efficacy on diurnal and nocturnal alveolar gas exchange, quality of life and quality of sleep. ISRCTN13981084 . Registered: 27 February 2017 (retrospectively registered).

Effects of sleep bruxism on functional and occlusal parameters: a prospective controlled investigation.

PubMed

Ommerborn, Michelle Alicia; Giraki, Maria; Schneider, Christine; Fuck, Lars Michael; Handschel, Jörg; Franz, Matthias; Hans-Michael Raab, Wolfgang; Schäfer, Ralf

2012-09-01

This study was conducted to verify the results of a preceding retrospective pilot study by means of a prospective controlled investigation including a larger sample size. Therefore, the aim of this clinical investigation was to analyze the relationship between sleep bruxism and several functional and occlusal parameters. The null hypothesis of this study was that there would be no differences among sleep bruxism subjects and non-sleep bruxism controls regarding several functional and occlusal parameters. Fifty-eight sleep bruxism subjects and 31 controls participated in this study. The diagnosis sleep bruxism was based on clinical criteria of the American Academy of Sleep Medicine. Sixteen functional and occlusal parameters were recorded clinically or from dental study casts. Similar to the recently published retrospective pilot study, with a mean slide of 0.77 mm (s.d., 0.69 mm) in the sleep bruxism group and a mean slide of 0.4 mm (s.d., 0.57 mm) in the control group, the evaluation of the mean comparison between the two groups demonstrated a larger slide from centric occlusion to maximum intercuspation in sleep bruxism subjects (Mann-Whitney U-test; P=0.008). However, following Bonferroni adjustment, none of the 16 occlusal and functional variables differed significantly between the sleep bruxism subjects and the non-sleep bruxism controls. The present study shows that the occlusal and functional parameters evaluated do not differ between sleep bruxism subjects and non-sleep bruxism subjects. However, as the literature reveals a possible association between bruxism and certain subgroups of temporomandibular disorders, it appears advisable to incorporate the individual adaptive capacity of the stomatognathic system into future investigations.

Prospective pilots of routine data capture by paediatricians in clinics and validation of the Disabilities Complexity Scale.

PubMed

Horridge, Karen A; Mcgarry, Kenneth; Williams, Jane; Whitlingum, Gabriel

2016-06-01

To pilot prospective data collection by paediatricians at the point of care across England using a defined terminology set; demonstrate feasibility of data collection and utility of data outputs; and confirm that counting the number of needs per child is valid for quantifying complexity. Paediatricians in 16 hospital and community settings collected and anonymized data. Participants completed a survey regarding the process. Data were analysed using R version 3.1.2. Overall, 8117 needs captured from 1224 consultations were recorded. Sixteen clinicians responded positively about the process and utility of data collection. The sum of needs varied significantly (p<0.01) by level of gross motor function ascertained using the Gross Motor Function Classification System for children with cerebral palsy; epilepsy severity as defined by level of expertise required to manage it; and by severity of intellectual disability. Prospective data collection at the point of clinical care proved possible without disrupting clinics, even for those with the most complex needs, and took the least time when done electronically. Counting the number of needs was easy to do, and quantified complexity in a way that informed clinical care for individuals and related directly to validated scales of functioning. Data outputs could inform more appropriate design and commissioning of quality services. © 2016 Mac Keith Press.

A pilot single arm observational study of sofosbuvir/ledipasvir (200 + 45 mg) in 6- to 12- year old children.

PubMed

El-Shabrawi, M H F; Kamal, N M; El-Khayat, H R; Kamal, E M; AbdElgawad, M M A H; Yakoot, M

2018-04-25

No available data on the use of sofosbuvir/ledipasvir combination in treatment of hepatitis C virus (HCV) infection in children 6- to 12- year old. To assess the safety and efficacy of sofosbuvir plus ledipasvir in children 6- to 12- year old with chronic HCV genotype 4 infection. This is a pilot prospective single arm observational open-label multicentre study. A total of 20 consecutive eligible chronic HCV infected children, aged from 6- to 12- years were included in this study and treated with a fixed sofosbuvir/ledipasvir combination in half the adult dose (200/45 mg) once daily for 12 weeks. Laboratory tests including virological markers were measured at baseline, 2, 4, 8 and 12 weeks (end of treatment [EOT]), and 12 weeks after end of treatment for sustained virological response 12 (SVR12). The intention-to-treat (ITT) SVR12 rate was 19/20 (95%; 95% CI: 76.4%-99.1%). SVR12 was not assessed in one patient who was lost to follow-up after showing viral negativity at the EOT12. All the remaining 19 patients (100%, 95% CI: 83.18%-100%) who completed the full protocol and follow-up visits achieved SVR12 with normal liver, haematological, and renal function tests and no side effects or fatalities. This pilot study demonstrated that the fixed dose sofosbuvir/ledipasvir combination could be safe and effective treatment in children 6- to 12- years with chronic hepatitis C genotype 4 infection. Our pilot results might encourage larger and multicentre studies in this age group. © 2018 John Wiley & Sons Ltd.

Development and pilot testing of a mobile health solution for asthma self-management: asthma action plan smartphone application pilot study.

PubMed

Licskai, Christopher; Sands, Todd W; Ferrone, Madonna

2013-01-01

Collaborative self-management is a core recommendation of national asthma guidelines; the written action plan is the knowledge tool that supports this objective. Mobile health technologies have the potential to enhance the effectiveness of the action plan as a knowledge translation tool. To design, develop and pilot a mobile health system to support asthma self-management. The present study was a prospective, single-centre, nonrandomized, pilot preintervention-postintervention analysis. System design and development were guided by an expert steering committee. The network included an agnostic web browser-based asthma action plan smartphone application (SPA). Subjects securely transmitted symptoms and peak flow data daily, and received automated control assessment, treatment advice and environmental alerts. Twenty-two adult subjects (mean age 47 years, 82% women) completed the study. Biophysical data were received on 84% of subject days (subject day = 1 subject × 1 day). Subjects viewed their action plan current zone of control on 54% and current air quality on 61% of subject days, 86% followed self-management advice and 50% acted to reduce exposure risks. A large majority affirmed ease of use, clarity and timeliness, and 95% desired SPA use after the study. At baseline, 91% had at least one symptom criterion for uncontrolled asthma and 64% had ≥2, compared with 45% (P=0.006) and 27% (P=0.022) at study close. Mean Asthma Quality of Life Questionnaire score improved from 4.3 to 4.8 (P=0.047). A dynamic, real-time, interactive, mobile health system with an integrated asthma action plan SPA can support knowledge translation at the patient and provider levels.

Wii-Fit for Improving Gait and Balance in an Assisted Living Facility: A Pilot Study

PubMed Central

Padala, Kalpana P.; Padala, Prasad R.; Malloy, Timothy R.; Geske, Jenenne A.; Dubbert, Patricia M.; Dennis, Richard A.; Garner, Kimberly K.; Bopp, Melinda M.; Burke, William J.; Sullivan, Dennis H.

2012-01-01

Objectives. To determine the effects on balance and gait of a Wii-Fit program compared to a walking program in subjects with mild Alzheimer's dementia (AD). Methods. A prospective randomized (1 : 1) pilot study with two intervention arms was conducted in an assisted living facility with twenty-two mild AD subjects. In both groups the intervention occurred under supervision for 30 minutes daily, five times a week for eight weeks. Repeated measures ANOVA and paired t-tests were used to analyze changes. Results. Both groups showed improvement in Berg Balance Scale (BBS), Tinetti Test (TT) and Timed Up and Go (TUG) over 8 weeks. However, there was no statistically significant difference between the groups over time. Intragroup analysis in the Wii-Fit group showed significant improvement on BBS (P = 0.003), and TT (P = 0.013). The walking group showed a trend towards improvement on BBS (P = 0.06) and TUG (P = 0.07) and significant improvement in TT (P = 0.06). Conclusion. This pilot study demonstrates the safety and efficacy of Wii-Fit in an assisted living facility in subjects with mild AD. Use of Wii-Fit resulted in significant improvements in balance and gait comparable to those in the robust monitored walking program. These results need to be confirmed in a larger, methodologically sound study. PMID:22745909

Maternal/fetal metabolomes appear to mediate the impact of arsenic exposure on birth weight: A pilot study.

PubMed

Wei, Yongyue; Shi, Qianwen; Wang, Zhaoxi; Zhang, Ruyang; Su, Li; Quamruzzaman, Quazi; Rahman, Mahmuder; Chen, Feng; Christiani, David C

2017-05-01

Arsenic exposure has been associated with low birth weight. However, the underlying mechanisms are not well understood. Alterations to metabolites may act as causal mediators of the effect of arsenic exposure on low birth weight. This pilot study aimed to explore the role of metabolites in mediating the association of arsenic exposure on infant birth weight. Study samples were selected from a well-established prospectively enrolled cohort in Bangladesh comprising 35 newborns and a subset of 20 matched mothers. Metabolomics profiling was performed on 35 cord blood samples and 20 maternal peripheral blood samples collected during the second trimester of pregnancy. Inorganic arsenic (iAs) exposure was evaluated via cord blood samples and maternal toenail samples collected during the first trimester. Multiple linear regression and mediation analyses were used to explore the relationship between iAs exposure, metabolite alterations, and low birth weight. Cord blood arsenic level was correlated with elevated levels of 17-methylstearate, laurate (12:0) and 4-vinylphenol sulfate along with lower birth weight. Prenatal maternal toenail iAs level was associated with two peripheral blood metabolites (butyrylqlycine and tartarate), which likely contributed to higher cord blood iAs levels both independently and interactively. Findings of this pilot study indicate that both intrauterine and maternal peripheral blood metabolites appear to influence the toxic effect of inorganic arsenic exposure on low birth weight.

Collaborative palliative care for advanced heart failure: outcomes and costs from the 'Better Together' pilot study.

PubMed

Pattenden, Jill F; Mason, Anne R; Lewin, R J P

2013-03-01

Patients with heart failure often receive little supportive or palliative care. 'Better Together' was a 2-year pilot study of a palliative care service for patients with advanced congestive heart failure (CHF). To determine if the intervention made it more likely that patients would be cared for and die in their place of choice, and to investigate its cost-effectiveness. This pragmatic non-randomised pilot evaluation was set in two English primary care trusts (Bradford and Poole). Prospective patient-level data on outcomes and costs were compared with data from a historical control group of clinically comparable patients. Outcomes included death in preferred place of care (available only for the intervention group) and 'hospital admissions averted'. Costs included medical procedures, inpatient care and the direct cost of providing the intervention. 99 patients were referred. Median survival from referral was 48 days in Bradford and 31 days in Poole. Most patients who died did so in their preferred place of death (Bradford 70%, Poole 77%). An estimated 14 and 18 hospital admissions for heart failure were averted in Bradford and Poole, respectively. The average cost-per-heart failure admission averted was £1529 in Bradford, but the intervention was cost saving in Poole. However, there was considerable uncertainty around these cost-effectiveness estimates. This pilot study provides tentative evidence that a collaborative home-based palliative care service for patients with advanced CHF may increase the likelihood of death in place of choice and reduce inpatient admissions. These findings require confirmation using a more robust methodological framework.

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

PubMed

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

2017-07-01

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

Development and prospect of unmanned aerial vehicles for agricultural production management

USDA-ARS?s Scientific Manuscript database

Unmanned aerial vehicles have been developed and applied to support agricultural production management. Compared to piloted aircrafts, an Unmanned Aerial Vehicle (UAV) can focus on small crop fields in lower flight altitude than regular airplanes to perform site-specific management with high precisi...

Use of the SONET score to evaluate Urgent Care Center overcrowding: a prospective pilot study

PubMed Central

Wang, Hao; Robinson, Richard D; Cowden, Chad D; Gorman, Violet A; Cook, Christopher D; Gicheru, Eugene K; Schrader, Chet D; Jayswal, Rani D; Zenarosa, Nestor R

2015-01-01

Objectives To derive a tool to determine Urgent Care Center (UCC) crowding and investigate the association between different levels of UCC overcrowding and negative patient care outcomes. Design Prospective pilot study. Setting Single centre study in the USA. Participants 3565 patients who registered at UCC during the 21-day study period were included. Patients who had no overcrowding statuses estimated due to incomplete collection of operational variables at the time of registration were excluded in this study. 3139 patients were enrolled in the final data analysis. Primary and secondary outcome measures A crowding estimation tool (SONET: Severely overcrowded, Overcrowded and Not overcrowded Estimation Tool) was derived using the linear regression analysis. The average length of stay (LOS) in UCC patients and the number of left without being seen (LWBS) patients were calculated and compared under the three different levels of UCC crowding. Results Four independent operational variables could affect the UCC overcrowding score including the total number of patients, the number of results pending for patients, the number of patients in the waiting room and the longest time a patient was stationed in the waiting room. In addition, UCC overcrowding was associated with longer average LOS (not overcrowded: 133±76 min, overcrowded: 169±79 min, and severely overcrowded: 196±87 min, p<0.001) and an increased number of LWBS patients (not overcrowded: 0.28±0.69 patients, overcrowded: 0.64±0.98, and severely overcrowded: 1.00±0.97). Conclusions The overcrowding estimation tool (SONET) derived in this study might be used to determine different levels of crowding in a high volume UCC setting. It also showed that UCC overcrowding might be associated with negative patient care outcomes. PMID:25872940

Evaluating success of autotransplantation of embedded/impacted third molars harvested using piezosurgery: a pilot study.

PubMed

Nagori, Shakil Ahmed; Jose, Anson; Bhutia, Ongkila; Roychoudhury, Ajoy

2014-11-01

To evaluate the success of autogenous transplantation of embedded/impacted third molars harvested using piezosurgery. This prospective pilot study enrolled 20 healthy patients with non-restorable first/second molars and a caries-free retrievable embedded/impacted third molar. Piezosurgery was used for removing inter-radicular bone at the recipient socket as well as for bone removal around the donor teeth. After an average follow-up of 16.4 months (SD = 1.9), 18 cases were successful with formation of periodontal ligament around the teeth. One tooth was lost due to infection at 1 month. One patient was lost to follow-up. There was no root resorption or ankylosis in any of the cases. In six donor teeth with complete root formation, root canal treatment was carried out. All the remaining teeth responded positively with vitality testing. Piezosurgery is an effective device if embedded/impacted third molars are to be harvested for successful autogenous transplantation.

Estimation and quantification of human DNA in dental calculus: A pilot study.

PubMed

Singh, Udita; Goel, Saurabh

2017-01-01

Identification using DNA has proved its accuracy multiple times in the field of forensic investigations. Investigators usually rely on either teeth or bone as the DNA reservoirs. However, there are instances where the skeletal or dental remains are not available or not preserved properly. Moreover, due to religious beliefs, the family members of the dead do not allow the investigating team to damage the remains for the sole purpose of identification. To investigate the presence of human DNA in dental calculus and to quantify the amount, if present. This prospective single-blinded pilot study included twenty subjects selected from the patients visiting a dental college. The samples of dental calculus were collected from the thickest portion of calculus deposited on the lingual surfaces of mandibular incisors. These samples were decontaminated and subjected to gel electrophoresis for DNA extraction. DNA was found in 85% cases. The amount of DNA varied from 21 to 37 μg/ml of dental calculus. Dental calculus is a rich reservoir of human DNA.

A Pilot Study of Quantitative MRI Measurements of Ventricular Volume and Cortical Atrophy for the Differential Diagnosis of Normal Pressure Hydrocephalus

PubMed Central

Moore, Dana W.; Kovanlikaya, Ilhami; Heier, Linda A.; Raj, Ashish; Huang, Chaorui; Chu, King-Wai; Relkin, Norman R.

2012-01-01

Current radiologic diagnosis of normal pressure hydrocephalus (NPH) requires a subjective judgment of whether lateral ventricular enlargement is disproportionate to cerebral atrophy based on visual inspection of brain images. We investigated whether quantitative measurements of lateral ventricular volume and total cortical thickness (a correlate of cerebral atrophy) could be used to more objectively distinguish NPH from normal controls (NC), Alzheimer's (AD), and Parkinson's disease (PD). Volumetric MRIs were obtained prospectively from patients with NPH (n = 5), PD (n = 5), and NC (5). Additional NC (n = 5) and AD patients (n = 10) from the ADNI cohort were examined. Although mean ventricular volume was significantly greater in the NPH group than all others, the range of values overlapped those of the AD group. Individuals with NPH could be better distinguished when ventricular volume and total cortical thickness were considered in combination. This pilot study suggests that volumetric MRI measurements hold promise for improving NPH differential diagnosis. PMID:21860791

The use of mucograft collagen matrix to augment the zone of keratinized tissue around teeth: a pilot study.

PubMed

Nevins, Myron; Nevins, Marc L; Kim, Soo-Woo; Schupbach, Peter; Kim, David M

2011-01-01

This prospective split-mouth pilot case series compared the use of a bilayer collagen matrix (CM) to an autogenous gingival graft (AGG) in the ability to increase the zone of keratinized attached gingiva. Five patients with inadequate amounts of keratinized attached gingiva bilaterally in the posterior mandible were enrolled using a split-mouth design. There were statistically significant increases in attached gingiva at all test (CM) and control (AGG) sites. The CM sites at 12 months blended well with surrounding tissues, while the AGG sites were morphologically dissimilar to the adjacent areas. Biopsy results showed intrapatient histologic similarity between CM and AGG treatments, with all sites exhibiting mature connective tissue covered by keratinized epithelium. Thus, the obtained data support further investigations in evaluating the role of CM as a viable alternative to AGG in augmenting areas deficient in keratinized gingiva.

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

PubMed

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

2016-08-18

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

[Auto-suture stapler EEA in surgery of the colon and rectum [author's transl)].

PubMed

Thiede, A; Troidl, H; Poser, H; Jostarndt, L; Hamelmann, H

1980-01-01

The increasing use of auto-suture staplers for gastrointestinal anastomoses makes it necessary to test the value of this new method of suturing. In a "pilot study" the practicability, the tightness and permeability of the anastomosis and complications were tested and analysed in a total of 30 colon and rectal anastomoses using the EEA-suture gun. The results of 14 colon resections and 16 low anterior resections justify the further use of the EEA auto-suture apparatus and raise the question of a prospective controlled random study in which manual and mechanical machine sutured anastomoses are compared.

Efficacy and safety of oral alitretinoin in severe oral lichen planus--results of a prospective pilot study.

PubMed

Kunz, M; Urosevic-Maiwald, M; Goldinger, S M; Frauchiger, A L; Dreier, J; Belloni, B; Mangana, J; Jenni, D; Dippel, M; Cozzio, A; Guenova, E; Kamarachev, J; French, L E; Dummer, R

2016-02-01

Patients with severe oral lichen planus refractory to standard topical treatment currently have limited options of therapy suitable for long-term use. Oral alitretinoin (9-cis retinoic acid) was never systematically investigated in clinical trials, although case reports suggest its possible efficacy. To assess the efficacy and safety of oral alitretinoin taken at 30 mg once daily for up to 24 weeks in the treatment of severe oral lichen planus refractory to standard topical therapy. We conducted a prospective open-label single arm pilot study to test the efficacy and safety of 30 mg oral alitretinoin once daily for up to 24 weeks in severe oral lichen planus. Ten patients were included in the study. Primary end point was reduction in signs and symptoms measured by the Escudier severity score. Secondary parameters included pain and quality of life scores. Safety parameters were assessed during a follow-up period of 5 weeks. A substantial response at the end of treatment, i.e. >50% reduction in disease severity measured by the Escudier severity score, was apparent in 40% of patients. Therapy was well tolerated. Adverse events were mild and included headache, mucocutaneous dryness, musculoskeletal pain, increased thyroid-stimulating hormone and dyslipidaemia. Alitretinoin given at 30 mg daily reduced disease severity of severe oral lichen planus in a substantial proportion of patients refractory to standard treatment, was well tolerated and may thus represent one therapeutic option for this special group of patients. © 2015 European Academy of Dermatology and Venereology.

A training approach to improve stepping automaticity while dual-tasking in Parkinson's disease: A prospective pilot study.

PubMed

Chomiak, Taylor; Watts, Alexander; Meyer, Nicole; Pereira, Fernando V; Hu, Bin

2017-02-01

Deficits in motor movement automaticity in Parkinson's disease (PD), especially during multitasking, are early and consistent hallmarks of cognitive function decline, which increases fall risk and reduces quality of life. This study aimed to test the feasibility and potential efficacy of a wearable sensor-enabled technological platform designed for an in-home music-contingent stepping-in-place (SIP) training program to improve step automaticity during dual-tasking (DT). This was a 4-week prospective intervention pilot study. The intervention uses a sensor system and algorithm that runs off the iPod Touch which calculates step height (SH) in real-time. These measurements were then used to trigger auditory (treatment group, music; control group, radio podcast) playback in real-time through wireless headphones upon maintenance of repeated large amplitude stepping. With small steps or shuffling, auditory playback stops, thus allowing participants to use anticipatory motor control to regain positive feedback. Eleven participants were recruited from an ongoing trial (Trial Number: ISRCTN06023392). Fear of falling (FES-I), general cognitive functioning (MoCA), self-reported freezing of gait (FOG-Q), and DT step automaticity were evaluated. While we found no significant effect of training on FES-I, MoCA, or FOG-Q, we did observe a significant group (music vs podcast) by training interaction in DT step automaticity (P<0.01). Wearable device technology can be used to enable musically-contingent SIP training to increase motor automaticity for people living with PD. The training approach described here can be implemented at home to meet the growing demand for self-management of symptoms by patients.

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

PubMed

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

2018-05-01

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

Argon plasma coagulation treatment of anal high-grade squamous intraepithelial lesions in men who have sex with men living with HIV: results of a 2-year prospective pilot study.

PubMed

de Pokomandy, A; Rouleau, D; Lalonde, R; Beauvais, C; de Castro, C; Coutlée, F

2018-02-01

Men who have sex with men (MSM) living with HIV are at high risk for anal high-grade squamous intraepithelial lesions (HSILs) and cancer. The best management of anal HSIL remains unclear. Our objective was to assess whether argon plasma coagulation (APC) could be safe, well tolerated and efficient to treat anal HSILs in MSM living with HIV. A prospective phase II, open-label, pilot study was conducted to evaluate APC to treat anal HSILs in 20 HIV-positive MSM. Participants were followed for 2 years after their first treatment. Twenty men with persistent HSILs completed the 2-year study. Their baseline median CD4 count was 490 cells/μL and 85% had undetectable HIV viral loads. Overall, 65% (13/20) of participants were clear of HSILs at their 24-month visit. The initial response rates after the first, second and third APC treatments were 45%, 44% and 67%, respectively, but recurrences were common. The main side effect was pain during and within 1 week after the treatments. There were no long-term side effects, nor serious adverse events related to the procedure. Cost is a drawback. APC can be used to treat anal HSILs in HIV-seropositive MSM, and requires repeated treatment because of a high recurrence rate. As successful treatment of human papillomavirus (HPV) infection or eradication of the anal transitional zone remains impossible, HSIL treatment is challenging and requires long-term follow-up. © 2017 British HIV Association.

A 52-week pilot study of the effects of exenatide on body weight in patients with hypothalamic obesity.

PubMed

Lomenick, Jefferson P; Buchowski, Maciej S; Shoemaker, Ashley H

2016-06-01

Hypothalamic obesity (HO) is a common complication of hypothalamic tumors, and effective therapies are lacking. The objective of this pilot study was to investigate changes in body weight before and during treatment with exenatide. This was a prospective, open-label, 52-week pilot study of exenatide (10 mcg b.i.d.) in adults with HO. Ten patients enrolled, and eight completed the study. Study measures included indirect calorimetry, body composition, buffet meals, diet recall, actigraphy, and hormone assays. Participants had obesity with a baseline weight of 137.2 ± 37.6 kg. Exenatide therapy was well tolerated. Change in weight with exenatide therapy was not significant (-1.4 ± 4.3 kg [95% CI -4.9 to 2.2], P = 0.40), but six out of eight completers lost weight (-6.2 to -0.2 kg). Participants reported significantly lower intake on food recall during treatment compared with baseline (7837.8 ± 2796.6 vs. 6258.4 ± 1970.7 kJ [95% CI -2915.8 to -242.6], P = 0.027), but there was no change in intake during buffet meals. Significant weight loss was not observed in patients with HO treated with exenatide, but 75% of completers had stable or decreasing weight. Further studies are needed to evaluate weight loss efficacy in patients with HO. © 2016 The Obesity Society.

A pilot study of loss aversion for drug and non-drug commodities in cocaine users.

PubMed

Strickland, Justin C; Beckmann, Joshua S; Rush, Craig R; Stoops, William W

2017-11-01

Numerous studies in behavioral economics have demonstrated that individuals are more sensitive to the prospect of a loss than a gain (i.e., loss aversion). Although loss aversion has been well described in "healthy" populations, little research exists in individuals with substance use disorders. This gap is notable considering the prominent role that choice and decision-making play in drug use. The purpose of this pilot study was to evaluate loss aversion in active cocaine users. Current cocaine users (N=38; 42% female) participated in this within-subjects laboratory pilot study. Subjects completed a battery of tasks designed to assess loss aversion for drug and non-drug commodities under varying risk conditions. Standardized loss aversion coefficients (λ) were compared to theoretically and empirically relevant normative values (i.e., λ=2). Compared to normative loss aversion coefficient values, a precise and consistent decrease in loss aversion was observed in cocaine users (sample λ≈1). These values were observed across drug and non-drug commodities as well as under certain and risky conditions. These data represent the first systematic study of loss aversion in cocaine-using populations and provide evidence for equal sensitivity to losses and gains or loss equivalence. Futures studies should evaluate the specificity of these effects to a history of cocaine use as well as the impact of manipulations of loss aversion on drug use to determine how this phenomenon may contribute to intervention development efforts. Copyright © 2017 Elsevier B.V. All rights reserved.

A Prospective Study of Bone Tumor Response Assessment in Metastatic Breast Cancer

PubMed Central

Hayashi, Naoki; Costelloe, Colleen M.; Hamaoka, Tsuyoshi; Wei, Caimiao; Niikura, Naoki; Theriault, Richard L.; Hortobagyi, Gabriel N.; Madewell, John E.; Ueno, Naoto T.

2013-01-01

In this pilot study, we prospectively compared the response of bone metastasis assessed by our MD Anderson (MDA) bone tumor response criteria (computed tomography [CT], plain radiography [XR], and skeletal scintigraphy [SS]) with the response assessed by the World Health Organization (WHO) criteria (XR and SS). Both MDA and WHO criteria predicted progression-free survival (PFS) of patients at 6 months but not at an earlier time point. Background In our previous study, new MD Anderson (MDA) bone tumor response criteria (based on computed tomography [CT], plain radiography [XR], and skeletal scintigraphy [SS]) predicted progression-free survival (PFS) better than did World Health Organization (WHO) bone tumor response criteria (plain radiography [XR] and SS) among patients with breast cancer and bone-only metastases. In this pilot study, we tested whether MDA criteria could reveal bone metastasis response earlier than WHO criteria in patients with newly diagnosed breast cancer with osseous and measurable nonosseous metastases. Methods We prospectively analyzed bone metastasis response using each imaging modality and set of bone response criteria to distinguish progressive disease (PD) from non-PD and their association with PFS and overall survival (OS). We also compared the response of osseous metastases assessed by both criteria with the response of nonosseous measurable lesions. Results The median follow-up period was 26.7 months (range, 6.1–53.3 months) in 29 patients. PFS rates differed at 6 months based on the classification of PD or non-PD using either set of criteria (MDA, P = .002; WHO, P = .014), but these rates, as well as OS, did not differ at 3 months. Response in osseous metastases by either set of criteria did not correlate with the response in nonosseous metastases. Conclusion MDA and WHO criteria predicted PFS of patients with osseous metastases at 6 months but not at an earlier time point. We plan a well-powered study to determine the role of MDA criteria in predicting bone tumor response by incorporating 18-fluorodeoxyglucose (18F) positron emission tomography (FDG-PET)/CT to see if findings using this modality are earlier than those with WHO criteria. PMID:23098575

Undiagnosed Primary Hyperparathyroidism and Recurrent Miscarriage: The First Prospective Pilot Study.

PubMed

DiMarco, Aimee; Christakis, Ioannis; Constantinides, Vasilis; Regan, Lesley; Palazzo, F Fausto

2018-03-01

Primary hyperparathyroidism (pHPT) in pregnancy is reported to be associated with significant maternal and foetal complications and an up to threefold increase in the risk of miscarriage. However, the true incidence of pHPT in pregnancy, complete and miscarried, is unknown and there are no data on the prevalence of undiagnosed pHPT in recurrent miscarriage (RM) (≥3 consecutive miscarriages under 24-week gestation). This is the first prospective study aiming to establish the prevalence of undiagnosed pHPT in RM. Following UK National ethics committee approval, women who had experienced 3 or more consecutive miscarriages were recruited from a nationwide RM clinic. Serum corrected calcium, phosphate, PTH and vitamin D were evaluated. Patients with raised serum calcium and/or PTH were recalled for confirmatory tests. Power calculations suggested that a minimum of 272 patients were required to demonstrate a clinically significant incidence of pHPT. Three hundred women were recruited, median age 35 years (range 19-42). Eleven patients had incomplete data, leaving 289 patients suitable for analysis; 50/289 patients (17%) with abnormal tests were recalled. The prevalence of vitamin D deficiency (<25 nmol/l) and insufficiency (25-75 nmol/l) was 8.7 and 67.8%, respectively. One patient was diagnosed with pHPT (0.34%) and underwent successful parathyroidectomy. The prevalence of undiagnosed pHPT (0.34%) in RM in this study appears to be many times greater than the 0.05% expected in this age group. The findings of this pilot study merit follow-up with a larger-scale study. Routine serum calcium estimation is not currently undertaken in RM and should be considered.

A 4-Week Preoperative Ketogenic Micronutrient-Enriched Diet Is Effective in Reducing Body Weight, Left Hepatic Lobe Volume, and Micronutrient Deficiencies in Patients Undergoing Bariatric Surgery: a Prospective Pilot Study.

PubMed

Schiavo, Luigi; Pilone, Vincenzo; Rossetti, Gianluca; Barbarisi, Alfonso; Cesaretti, Manuela; Iannelli, Antonio

2018-03-03

Before bariatric surgery (BS), moderate weight loss, left hepatic lobe volume reduction, and micronutrient deficiency (MD) identification and correction are desirable. The objective of this study was to assess the safety and the effectiveness of a 4-week preoperative ketogenic micronutrient-enriched diet (KMED) in reducing body weight (BW), left hepatic lobe volume, and correcting MD in patients scheduled for BS. In this prospective pilot study, a cohort of morbidly obese patients (n = 27, 17 females, 10 males) with a mean body mass index (BMI) of 45.2 kg/m 2 scheduled for BS underwent a 4-week preoperative KMED. Their BW, BMI, fat mass (FM), fat-free mass (FFM), resting metabolic rate (RMR), left hepatic lobe volume, micronutrient status, and biochemical and metabolic patterns were measured before and after the 4-week KMED. Patient compliance was assessed by validated questionnaires (3-day estimated food records and 72-h recall). Qualitative methods (5-point Likert questionnaire) were used to measure diet acceptability and side effects. All patients completed the study. We observed highly significant decreases in BW (- 10.3%, p < 0.001, in males; - 8.2%, p < 0.001, in females), left hepatic lobe volume (- 19.8%, p < 0.001), and an amelioration of patient micronutrient status. All patients showed a high frequency of acceptability and compliance in following the diet. No adverse side effect was reported. This study demonstrates that a 4-week preoperative KMED is safe and effective in reducing BW, left hepatic lobe volume, and correcting MD in obese patients scheduled for BS.

Impact on seniors of the patient-centered medical home: evidence from a pilot study.

PubMed

Fishman, Paul A; Johnson, Eric A; Coleman, Kathryn; Larson, Eric B; Hsu, Clarissa; Ross, Tyler R; Liss, David; Tufano, James; Reid, Robert J

2012-10-01

To assess the impact on health care cost and quality among seniors of a patient-centered medical home (PCMH) pilot at Group Health Cooperative, an integrated health care system in Washington State. A prospective before-and-after evaluation of the experience of seniors receiving primary care services at 1 pilot clinic compared with seniors enrolled at the remaining 19 primary care clinics owned and operated by Group Health. Analyses of secondary data on quality and cost were conducted for 1,947 seniors in the PCMH clinic and 39,396 seniors in the 19 control clinics. Patient experience with care was based on survey data collected from 487 seniors in the PCMH clinic and of 668 in 2 specific control clinics that were selected for their similarities in organization and patient composition to the pilot clinic. After adjusting for baseline, seniors in the PCMH clinic reported higher ratings than controls on 3 of 7 patient experience scales. Seniors in the PCMH clinic had significantly greater quality outcomes over time, but this difference was not significant relative to control. PCMH patients used more e-mail, phone, and specialist visits but fewer emergency services and inpatient admissions for ambulatory care sensitive conditions. At 1 and 2 years, the PCMH and control clinics did not differ significantly in overall costs. A PCMH redesign can be associated with improvements in patient experience and quality without increasing overall cost.

A Quasi-experimental outcomes analysis of a psychoeducation intervention for pregnant women with abuse-related posttraumatic stress.

PubMed

Rowe, Heather; Sperlich, Mickey; Cameron, Heather; Seng, Julia

2014-01-01

To test the effectiveness of a trauma-specific, psychoeducational intervention for pregnant women with a history of childhood maltreatment on six intrapartum and postpartum psychological outcomes. Quasi-experimental study comparing women from a single-group, pretest-posttest pilot intervention study with women matched from a prospective observational study. Rural and university-based prenatal clinics. Pregnant women entered the study by responding to an advertisement or by referral from a maternity care provider. Women could take part whether or not they met posttraumatic stress disorder diagnostic criteria. Outcomes data exist for 17 pilot intervention study participants and 43 matched observational study participants. Participants in the observational study received usual care. Participants in the pilot intervention study received usual care plus the intervention, a fully manualized, self-study program supported by weekly phone tutoring sessions with a health professional. The National Women's Study PTSD Module, the Peritraumatic Dissociation Experience Questionnaire, the Perception of Care Questionnaire, the Postpartum Depression Screening Scale, the Postpartum Bonding Questionnaire, and a semantic differential appraisal of the labor experience. Participants in the intervention study had better scores on all measures. Differences in means between participants in the intervention study and participants in the observational study equated to medium effect sized for dissociation during labor, rating of labor experience, and perception of care in labor and small effect sizes for postpartum posttraumatic stress disorder (PTSD) symptoms, postpartum depression symptoms, and motherinfant bonding. This trauma-specific intervention reaches and benefits pregnant women with a history of childhood maltreatment. © 2014 AWHONN, the Association of Women's Health, Obstetric and Neonatal Nurses.

A quasi-experimental outcomes analysis of a psychoeducation intervention for pregnant women with abuse-related posttraumatic stress

PubMed Central

Rowe, Heather; Sperlich, Mickey; Seng, Julia S.

2015-01-01

Objective To test the effectiveness of a trauma-specific psycho-educational intervention for pregnant women with a history of childhood maltreatment on six intrapartum and postpartum psychological outcomes. Design Quasi-experimental study comparing women from a single-group pretest-posttest pilot intervention study with women matched from a prospective observational study. Setting Rural and university-based prenatal clinics. Participants Pregnant women entered the study by responding to an advertisement or by referral from a maternity care provider. Women could take part whether or not they met posttraumatic stress disorder diagnostic criteria. Outcomes data exist for 17 pilot intervention study participants and 43 matched observational study participants. Interventions Participants in the observational study received usual care. Participants in the pilot intervention study received usual care plus the intervention, a fully manualized self-study program supported by weekly phone tutoring sessions with a health professional. Main Outcome Measures The National Women’s Study PTSD Module; The Peritraumatic Dissociation Experience Questionnaire); The Perception of Care Questionnaire; The Postpartum Depression Screening Scale; The Postpartum Bonding Questionnaire; and a semantic differential appraisal of the labor experience. Results Participants in the intervention study had better scores on all measures. Differences in means between participants in the intervention study and participants in the observational study equated to medium effect sized for dissociation during labor, rating of labor experience, and perception of care in labor, and small effect sizes for postpartum PTSD symptoms, postpartum depression symptoms, and mother-infant bonding. Conclusion This trauma-specific intervention reaches and benefits pregnant women with a history of childhood maltreatment. PMID:24754455

Upfront triple combination therapy in pulmonary arterial hypertension: a pilot study.

PubMed

Sitbon, Olivier; Jaïs, Xavier; Savale, Laurent; Cottin, Vincent; Bergot, Emmanuel; Macari, Elise Artaud; Bouvaist, Hélène; Dauphin, Claire; Picard, François; Bulifon, Sophie; Montani, David; Humbert, Marc; Simonneau, Gérald

2014-06-01

Patients with severe pulmonary arterial hypertension (PAH) in New York Heart Association (NYHA) functional class (FC) III/IV have a poor prognosis, despite survival benefits being demonstrated with intravenous epoprostenol. In this pilot study, the efficacy and safety of a triple combination therapy regimen in patients with severe PAH was investigated. Data from newly diagnosed NYHA FC III/IV PAH patients (n=19) initiated on upfront triple combination therapy (intravenous epoprostenol, bosentan and sildenafil) were collected retrospectively from a prospective registry. Significant improvements in 6-min walk distance and haemodynamics were observed after 4 months' triple combination therapy in 18 patients (p<0.01); 17 patients had improved to NYHA FC I or II. One patient was not included in the month 4 assessment (due to an emergency lung transplant in month 3). At the final evaluation (mean ± sd 32 ± 19 months), all 18 patients had sustained clinical and haemodynamic improvement. Overall survival estimates for the triple combination cohort were 100% at 1, 2 and 3 years. Expected survival calculated from the French equation was 75% (95% CI 68-82%), 60% (95% CI 50-70%) and 49% (95% CI 38-60%) at 1, 2 and 3 years, respectively. This pilot study provides preliminary evidence of the long-term benefits of upfront triple combination therapy in patients with severe PAH. ©ERS 2014.

Balance exercise in patients with chronic sensory ataxic neuropathy: a pilot study.

PubMed

Riva, Nilo; Faccendini, Simone; Lopez, Ignazio D; Fratelli, Annamaria; Velardo, Daniele; Quattrini, Angelo; Gatti, Roberto; Comi, Giancarlo; Comola, Mauro; Fazio, Raffaella

2014-06-01

Although exercise therapy is considered part of the treatment of neuropathic patients, and somatosensory input is essential for motor learning, performance and neural plasticity, rehabilitation of patients with sensory ataxia has received little attention so far. The aim of this prospective pilot study was to explore the short- and medium-term efficacy of a 3-week intensive balance and treadmill exercise program in chronic ataxic neuropathy patients; 20 consecutive patients with leg overall disability sum score (ODSS-leg) ≥2, absent/mild motor signs, clinical and therapeutic stability ≥4 months were enrolled. Evaluations were done at baseline, at the end of treatment and at 3- and 6-month follow-up. Outcome measurements included: ODSS-leg, Berg balance scale, 6-min walk distance, and the functional independence measure (FIM) scale. The short-form-36 health status scale (SF-36) was used to measure health-related quality of life (HRQoL). ODSS-leg improved significantly compared with baseline, 3 weeks, 3 months (primary outcome), and 6 months follow-up. A significant improvement in all functional secondary outcome measurements and in some SF-36 subscales was also observed. This pilot study suggests that balance exercise is safe and well tolerated and might be effective in ameliorating disability and HRQoL in patients with chronic peripheral sensory ataxia. © 2014 Peripheral Nerve Society.

Endoscopic procedure with a modified Reiki intervention: a pilot study.

PubMed

Hulse, Rosalinda S; Stuart-Shor, Eileen M; Russo, Jonathan

2010-01-01

This pilot study examined the use of Reiki prior to colonoscopy to reduce anxiety and minimize intraprocedure medications compared with usual care. A prospective, nonblinded, partially randomized patient preference design was employed using 21 subjects undergoing colonoscopy for the first time. Symptoms of anxiety and pain were assessed using a Likert-type scale. Between-group differences were assessed using chi-square analyses and analysis of variance. There were no differences between the control (n = 10) and experimental (n = 11) groups on age (mean = 58 years, SD = 8.5) and gender (53% women). The experimental group had higher anxiety (4.5 vs. 2.6, p = .03) and pain (0.8 vs. 0.2, p = .42) scores prior to colonoscopy. The Reiki intervention reduced mean heart rate (-9 beats/minute), systolic blood pressure (-10 mmHg), diastolic blood pressure (-4 mmHg), and respirations (-3 breaths/minute). There were no between-group differences on intraprocedure medication use or postprocedure physiologic measures. Although the experimental group patients had more symptoms, they did not require additional pain medication during the procedure, suggesting that (1) anxious people may benefit from an adjunctive therapy; (2) anxiety and pain are decreased by Reiki therapy for patients undergoing colonoscopy, and (3) additional intraprocedure pain medication may not be needed for colonoscopy patients receiving Reiki therapy. This pilot study provided important insights in preparation for a rigorous, randomized, controlled clinical trial.

A pilot study of implantable cardiac device interrogation by emergency department personnel.

PubMed

Neuenschwander, James F; Hiestand, Brian C; Peacock, W Frank; Billings, John M; Sondrup, Cole; Hummel, John D; Abraham, William T

2014-03-01

Implanted devices (eg, pacemakers and defibrillators) provide valuable information and may be interrogated to obtain diagnostic information and to direct management. During admission to an emergency department (ED), significant time and cost are spent waiting for device manufacturer representatives or cardiologists to access the data. If ED personnel could safely interrogate implanted devices, more rapid disposition could occur, thus leading to potentially better outcomes at a reduced cost. This was a pilot study examining the feasibility of ED device interrogation. This was a prospective convenience sample study of patients presenting to the ED with any chief complaint and who had an implantable device capable of being interrogated by a Medtronic reader. After obtaining informed consent, study patients underwent device interrogation by ED research personnel. After reviewing the device data, the physician documented their opinions of the value of data in aiding care. Patients were followed up at intervals ranging from 30 days out to 1 year to determine adverse events relating to interrogation. Forty-four patients underwent device interrogation. Their mean age was 56 ± 14.7 years (range, 28-83), 75% (33/44) were male and 75% (33/44) were hospitalized from the ED. The interrogations took less than 10 minutes 89% of the time. In 60% of the cases, ED physicians reported the data-assisted patient care. No adverse events were reported relating to the ED interrogations. In this pilot study, we found that ED personnel can safely and quickly interrogate implantable devices to obtain potentially useful clinical data.

[Mental disorders and female infertility].

PubMed

Schweiger, U; Wischmann, T; Strowitzki, T

2012-11-01

Approximately 5-10% of women in the reproductive years are affected by infertility which is associated with depression, anxiety and disturbed eating behavior. Part of this association can be explained by the emotional stress resulting from infertility. As mental disorders, such as depressive disorder or eating disorders are also prospectively associated with infertility, a bidirectional relationship is assumed. A special relationship exists between mental disorders and the main causes of ovulatory infertility, hypothalamic amenorrhea and polycystic ovary disease. The results of pilot studies support the assumption that psychotherapy may constitute an important component of the treatment of infertility.

Embryo selection using time-lapse analysis (Early Embryo Viability Assessment) in conjunction with standard morphology: a prospective two-center pilot study.

PubMed

Kieslinger, Dorit C; De Gheselle, Stefanie; Lambalk, Cornelis B; De Sutter, Petra; Kostelijk, E Hanna; Twisk, Jos W R; van Rijswijk, Joukje; Van den Abbeel, Etienne; Vergouw, Carlijn G

2016-11-01

Does prospective embryo selection using the results from the Eava Test (Early Embryo Viability Assessment) in combination with standard morphology increase the pregnancy rate of IVF and ICSI patients compared to embryo selection based on morphology only? Embryo selection using the Eeva Test plus standard morphology on Day 3 results in comparable pregnancy rates as conventional morphological embryo selection. Time-lapse monitoring of embryo development may represent a superior way to culture and select embryos in vitro. The Eeva Test records the development of each embryo with a cell-tracking system and predicts the likelihood (High, Medium or Low) that an embryo will form a blastocyst based on an automated analysis of early cell division timings. This trial was designed as a prospective, observational, two-center pilot study with a propensity matched control group. The analysis involved 280 of 302 enrolled patients who were included in the Eeva Test group in 2013 and 560 control patients who were treated in the years 2011-2013. The majority of transfers (98%) were single embryo transfers. Two academic hospitals (VUmc Amsterdam and UZ Gent) enrolled patients <41 years old, with <3 previous attempts and ≥5 normally fertilized eggs. Propensity matching was used to identify a propensity matched control group from a cohort of 1777 patients based on age, cycle number, oocyte number and number of fertilized oocytes. There was no difference in patient baseline characteristics between the two groups. The ongoing pregnancy rate (OPR) of patients enrolled in the Eeva Test group (34.3%; 96/280) did not differ significantly from the OPR in the propensity matched control group (34.6%, 194/560; P = 0.92). However, significantly less top quality embryos (eight-cell embryos with ≤25% fragmentation) were transferred in the Eeva Test group compared to the propensity matched control group (70.4% vs. 82.3%; P < 0.001). The transfer of Eeva High and Medium embryos resulted in a significantly higher OPR of 36.8% (89/242) compared to 18.4% (7/38) for Eeva Low embryos (P = 0.02). This pilot study is limited by its nonrandomized design with a concurrent and historical control. Our pilot data did not reveal significant differences between time-lapse based and conventional embryo selection. Interestingly, the pregnancy rates were comparable in both groups even though the morphological quality of the transferred embryos was significantly lower in the Eeva Test group compared to the propensity matched control group. A sufficiently powered three-armed randomized controlled trial (RCT) with a solid design should be performed to generate decisive evidence in the future. Progyny Inc., formerly Auxogyn provided the Eeva scopes, software and technical support for this study. The funding sources did neither influence data collection, management, analysis and interpretation of the data, nor the preparation of the manuscript. ClinicalTrials.gov: NCT01671644. © The Author 2016. Published by Oxford University Press on behalf of the European Society of Human Reproduction and Embryology. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

Vestibular rehabilitation using video gaming in adults with dizziness: a pilot study.

PubMed

Phillips, J S; Fitzgerald, J; Phillis, D; Underwood, A; Nunney, I; Bath, A

2018-03-01

To determine the effectiveness of vestibular rehabilitation using the Wii Fit balance platform, in adults with dizziness. A single-site prospective clinical trial was conducted in a university hospital in the UK. Forty patients with dizziness, who would normally be candidates for vestibular rehabilitation, were identified and considered as potential participants. Participants were randomised into either the treatment group (the Wii Fit group) or the control group (standard customised vestibular rehabilitation protocol). Participants were assessed over a 16-week period using several balance and quality of life questionnaires. Both exercise regimes resulted in a reduction of dizziness and an improvement in quality of life scores over time, but no statistically significant difference between the two interventions was identified. This pilot study demonstrated that use of the Wii Fit balance platform resulted in a statistically significant improvement in balance function and quality of life. Furthermore, outcomes were comparable to a similar group of individuals following a standard customised vestibular rehabilitation protocol. The study provides useful information to inform the design and execution of a larger clinical trial.

Impact of a Preemptive Multimodal Analgesia plus Femoral Nerve Blockade Protocol on Rehabilitation, Hospital Length of Stay, and Postoperative Analgesia after Primary Total Knee Arthroplasty: A Controlled Clinical Pilot Study

PubMed Central

Beaupre, Lauren A.; Johnston, D. Bill C.; Dieleman, Sherry; Tsui, Ban

2012-01-01

Purpose. To compare preemptive multimodal analgesia (PMMA) without femoral nerve blocks (FNB) to PMMA including FNB following total knee arthroplasty (TKA). Methods. In a prospective, controlled pilot study, subjects with noninflammatory arthritis undergoing TKA and a short postoperative stay received either PMMA + FNB (FNB group; n = 19) or PMMA only (PMMA group; n = 20). No preoperative group differences were noted. Evaluations occurred in hospital and at 2, 6, and 12 weeks postoperatively. The primary outcome (knee flexion) was measured on day two postoperatively. Rehabilitation indices, pain, analgesic use, and length of stay (LOS) were also measured. Results. All subjects completed the study. The only significant group differences were quadriceps motor blocks in the FNB group (P < 0.001). No significant differences were noted in ROM, pain levels, analgesic use, or hospital LOS. Conclusion. Other than the quadriceps motor block, no group differences were noted; both achieved satisfactory analgesia. Best postoperative pain management strategies when following a short hospital stay program are still unclear. PMID:22666096

Impact of a preemptive multimodal analgesia plus femoral nerve blockade protocol on rehabilitation, hospital length of stay, and postoperative analgesia after primary total knee arthroplasty: a controlled clinical pilot study.

PubMed

Beaupre, Lauren A; Johnston, D Bill C; Dieleman, Sherry; Tsui, Ban

2012-01-01

To compare preemptive multimodal analgesia (PMMA) without femoral nerve blocks (FNB) to PMMA including FNB following total knee arthroplasty (TKA). In a prospective, controlled pilot study, subjects with noninflammatory arthritis undergoing TKA and a short postoperative stay received either PMMA + FNB (FNB group; n = 19) or PMMA only (PMMA group; n = 20). No preoperative group differences were noted. Evaluations occurred in hospital and at 2, 6, and 12 weeks postoperatively. The primary outcome (knee flexion) was measured on day two postoperatively. Rehabilitation indices, pain, analgesic use, and length of stay (LOS) were also measured. All subjects completed the study. The only significant group differences were quadriceps motor blocks in the FNB group (P < 0.001). No significant differences were noted in ROM, pain levels, analgesic use, or hospital LOS. Other than the quadriceps motor block, no group differences were noted; both achieved satisfactory analgesia. Best postoperative pain management strategies when following a short hospital stay program are still unclear.

A Pilot Study: The importance of inter-individual differences in inorganic arsenic metabolism for birth weight outcome

PubMed Central

Gelmann, Elyssa R; Gurzau, Eugen; Gurzau, Anca; Goessler, Walter; Kunrath, Julie

2013-01-01

Inorganic arsenic (iAs) exposure is detrimental to birth outcome. We lack information regarding the potential for iAs metabolism to affect fetal growth. Our pilot study evaluated postpartum Romanian women with known birth weight outcome for differences in iAs metabolism. Subjects were chronically exposed to low-to-moderate drinking water iAs. We analyzed well water, arsenic metabolites in urine, and toenail arsenic. Urine iAs and metabolites, toenail iAs, and secondary methylation efficiency increased as an effect of exposure (p<0.001). Urine iAs and metabolites showed a significant interaction effect between exposure and birth weight. Moderately exposed women with low compared to normal birth weight outcome had greater metabolite excretion (p<0.03); 67% with low compared to 10% with normal birth weight outcome presented urine iAs >9μg/L (p=0.019). Metabolic partitioning of iAs toward excretion may impair fetal growth. Prospective studies on iAs excretion before and during pregnancy may provide a biomarker for poor fetal growth risk. PMID:24211595

Six-year clinical outcome of single implant-retained mandibular overdentures--a pilot study.

PubMed

Passia, Nicole; Wolfart, Stefan; Kern, Matthias

2015-10-01

The aim of this prospective pilot study was to evaluate the prosthodontic maintenance as well as the implant outcome of single implant-retained mandibular overdentures over an observation period of 6 years. Eleven edentulous patients received one single implant in the midline of the mandible. Denture bases were temporarily relined and 2 months later provided with a ball attachment for implant retention. Implant related parameters and prosthodontic maintenance interventions were assessed 4 weeks after implant loading and then once a year. Over a mean observation period of 75.9 months, no implant was lost. The most frequent prosthetic maintenance intervention was activation of the matrix due to loss of retention, followed by exchange of the female part. Eight denture bases had to be repaired after a fracture in the midline area. Within the limitations of this preliminary clinical study, the concept of a single midline implant to retain a mandibular complete denture was a successful treatment option for elderly edentulous patients. © 2014 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

Effects of a cardiovascular risk reduction intervention with psychobehavioral strategies for Korean adults with type 2 diabetes and metabolic syndrome.

PubMed

Kim, Chun-Ja; Kim, Dae-Jung; Park, Hyung-Ran

2011-01-01

Type 2 diabetes mellitus (DM) and metabolic syndrome are associated with high risk of cardiovascular disease (CVD) and depression. Although lifestyle modifications including regular exercise and weight control are recommended as a primary approach to glycemic control and CVD risk reduction for people with DM and/or metabolic syndrome, little is known concerning the effects of CVD risk reduction interventions using psychobehavioral strategies in this population. This pilot study investigated the effects of a 16-week CVD risk reduction intervention in Korean adults with type 2 DM and metabolic syndrome. A prospective, pretest and posttest, controlled, quasi-experimental design enrolled a convenience sample of 43 Korean adults with type 2 DM and metabolic syndrome at a university hospital. The adults in the intervention group participated in a 16-week CVD risk reduction intervention consisting of 150 minutes of regular exercise per week; 200- to 300-kcal reduced daily diet for weight control; one-on-one psychobehavioral counseling based on constructs from the Transtheoretical Model such as processes of change, self-efficacy, and decisional balance; and telephone coaching for behavioral modification. Participants in the control group received a booklet with basic diabetic education as part of their routine care. Repeated-measures analysis of variance was used for analyzing the effects of the CVD risk reduction intervention on cardiometabolic risk factors including the UK Prospective Diabetes Study score for 10-year CVD risk, glycated hemoglobin (HbA1c), and depression. The intervention group showed significant reductions (P < .05) at 16 weeks, compared with the control group on the UK Prospective Diabetes Study fatal risk scale (-1.73% vs -0.04%), triglycerides (-38.5 vs -15.1 mg/dL), fasting plasma glucose (-29.24 vs +1.77 mg/dL), HbA1c (-0.37% vs +0.17%), and depression (score, -3.24 vs 1.40) measurements. This pilot study yielded evidence for the beneficial impact of the CVD risk reduction intervention for Korean adults with type 2 DM and metabolic syndrome on improved glycemic control, reduced CVD risk, and depression.

Sibanye Methods for Prevention Packages Program Project Protocol: Pilot Study of HIV Prevention Interventions for Men Who Have Sex With Men in South Africa.

PubMed

McNaghten, Ad; Kearns, Rachel; Siegler, Aaron J; Phaswana-Mafuya, Nancy; Bekker, Linda-Gail; Stephenson, Rob; Baral, Stefan D; Brookmeyer, Ron; Yah, Clarence S; Lambert, Andrew J; Brown, Benjamin; Rosenberg, Eli; Blalock Tharp, Mondie; de Voux, Alex; Beyrer, Chris; Sullivan, Patrick S

2014-10-16

Human immunodeficiency virus (HIV) prevention intervention programs and related research for men who have sex with men (MSM) in the southern African region remain limited, despite the emergence of a severe epidemic among this group. With a lack of understanding of their social and sexual lives and HIV risks, and with MSM being a hidden and stigmatized group in the region, optimized HIV prevention packages for southern African MSM are an urgent public health and research priority. The objective of the Sibanye Health Project is to develop and evaluate a combination package of biomedical, behavioral, and community-level HIV prevention interventions and services for MSM in South Africa. The project consists of three phases: (1) a comprehensive literature review and summary of current HIV prevention interventions (Phase I), (2) agent-based mathematical modeling of HIV transmission in southern African MSM (Phase II), and (3) formative and stigma-related qualitative research, community engagement, training on providing health care to MSM, and the pilot study (Phase III). The pilot study is a prospective one-year study of 200 men in Cape Town and Port Elizabeth, South Africa. The study will assess a package of HIV prevention services, including condom and condom-compatible lubricant choices, risk-reduction counseling, couples HIV testing and counseling, pre-exposure prophylaxis (PrEP) for eligible men, and non-occupational post-exposure prophylaxis for men with a high risk exposure. The pilot study will begin in October 2014. Preliminary results from all components but the pilot study are available. We developed a literature review database with meta-data extracted from 3800 documents from 67 countries. Modeling results indicate that regular HIV testing and promotion of condom use can significantly impact new HIV infections among South African MSM, even in the context of high coverage of early treatment of HIV-positive men and high coverage of PrEP for at-risk HIV-negative men. Formative qualitative research consisted of 79 in-depth interviews, and six focus group discussions in Cape Town and Port Elizabeth. Analysis of these data has informed pilot study protocol development and has been documented in peer-reviewed manuscripts. Qualitative work regarding stigma faced by South African MSM resulted in finalized scales for use in the pilot study questionnaire. A total of 37 health care providers completed training designed to facilitate clinically and culturally competent care for MSM in the Eastern Cape. The design of a future, larger study of the HIV prevention package will be conducted at the end of the pilot study, powered to detect efficacy of the prevention package. Data from the updated mathematical model, results of the pilot study, acceptability data, and advancements in HIV prevention sciences will be considered in developing the final proposed package and study design. ClinicalTrials.gov NCT02043015; http://clinicaltrials.gov/show/NCT02043015 (Archived by WebCite at http://www.webcitation.org/6THvp7rAj).

Development of the 7-Item Binge-Eating Disorder Screener (BEDS-7)

PubMed Central

Deal, Linda S.; DiBenedetti, Dana B.; Nelson, Lauren; Fehnel, Sheri E.; Brown, T. Michelle

2016-01-01

Objective Develop a brief, patient-reported screening tool designed to identify individuals with probable binge-eating disorder (BED) for further evaluation or referral to specialists. Methods Items were developed on the basis of the DSM-5 diagnostic criteria, existing tools, and input from 3 clinical experts (January 2014). Items were then refined in cognitive debriefing interviews with participants self-reporting BED characteristics (March 2014) and piloted in a multisite, cross-sectional, prospective, noninterventional study consisting of a semistructured diagnostic interview (to diagnose BED) and administration of the pilot Binge-Eating Disorder Screener (BEDS), Binge Eating Scale (BES), and RAND 36-Item Short-Form Health Survey (RAND-36) (June 2014–July 2014). The sensitivity and specificity of classification algorithms (formed from the pilot BEDS item-level responses) in predicting BED diagnosis were evaluated. The final algorithm was selected to minimize false negatives and false positives, while utilizing the fewest number of BEDS items. Results Starting with the initial BEDS item pool (20 items), the 13-item pilot BEDS resulted from the cognitive debriefing interviews (n = 13). Of the 97 participants in the noninterventional study, 16 were diagnosed with BED (10/62 female, 16%; 6/35 male, 17%). Seven BEDS items (BEDS-7) yielded 100% sensitivity and 38.7% specificity. Participants correctly identified (true positives) had poorer BES scores and RAND-36 scores than participants identified as true negatives. Conclusions Implementation of the brief, patient-reported BEDS-7 in real-world clinical practice is expected to promote better understanding of BED characteristics and help physicians identify patients who may have BED. PMID:27486542

Development of the 7-Item Binge-Eating Disorder Screener (BEDS-7).

PubMed

Herman, Barry K; Deal, Linda S; DiBenedetti, Dana B; Nelson, Lauren; Fehnel, Sheri E; Brown, T Michelle

2016-01-01

Develop a brief, patient-reported screening tool designed to identify individuals with probable binge-eating disorder (BED) for further evaluation or referral to specialists. Items were developed on the basis of the DSM-5 diagnostic criteria, existing tools, and input from 3 clinical experts (January 2014). Items were then refined in cognitive debriefing interviews with participants self-reporting BED characteristics (March 2014) and piloted in a multisite, cross-sectional, prospective, noninterventional study consisting of a semistructured diagnostic interview (to diagnose BED) and administration of the pilot Binge-Eating Disorder Screener (BEDS), Binge Eating Scale (BES), and RAND 36-Item Short-Form Health Survey (RAND-36) (June 2014-July 2014). The sensitivity and specificity of classification algorithms (formed from the pilot BEDS item-level responses) in predicting BED diagnosis were evaluated. The final algorithm was selected to minimize false negatives and false positives, while utilizing the fewest number of BEDS items. Starting with the initial BEDS item pool (20 items), the 13-item pilot BEDS resulted from the cognitive debriefing interviews (n = 13). Of the 97 participants in the noninterventional study, 16 were diagnosed with BED (10/62 female, 16%; 6/35 male, 17%). Seven BEDS items (BEDS-7) yielded 100% sensitivity and 38.7% specificity. Participants correctly identified (true positives) had poorer BES scores and RAND-36 scores than participants identified as true negatives. Implementation of the brief, patient-reported BEDS-7 in real-world clinical practice is expected to promote better understanding of BED characteristics and help physicians identify patients who may have BED.

Different effectiveness of closed embryo culture system with time-lapse imaging (EmbryoScope(TM)) in comparison to standard manual embryology in good and poor prognosis patients: a prospectively randomized pilot study.

PubMed

Wu, Yan-Guang; Lazzaroni-Tealdi, Emanuela; Wang, Qi; Zhang, Lin; Barad, David H; Kushnir, Vitaly A; Darmon, Sarah K; Albertini, David F; Gleicher, Norbert

2016-08-24

Previously manual human embryology in many in vitro fertilization (IVF) centers is rapidly being replaced by closed embryo incubation systems with time-lapse imaging. Whether such systems perform comparably to manual embryology in different IVF patient populations has, however, never before been investigated. We, therefore, prospectively compared embryo quality following closed system culture with time-lapse photography (EmbryoScope™) and standard embryology. We performed a two-part prospectively randomized study in IVF (clinical trial # NCT92256309). Part A involved 31 infertile poor prognosis patients prospectively randomized to EmbryoScope™ and standard embryology. Part B involved embryos from 17 egg donor-recipient cycles resulting in large egg/embryo numbers, thus permitting prospectively alternative embryo assignments to EmbryoScope™ and standard embryology. We then compared pregnancy rates and embryo quality on day-3 after fertilization and embryologist time utilized per processed embryo. Part A revealed in poor prognosis patients no differences in day-3 embryo scores, implantation and clinical pregnancy rates between EmbryoScope™ and standard embryology. The EmbryoScope™, however, more than doubled embryology staff time (P < 0.0001). In Part B, embryos grown in the EmbyoScope™ demonstrated significantly poorer day-3 quality (depending on embryo parameter between P = 0.005 and P = 0.01). Suspicion that conical culture dishes of the EmbryoScope™ (EmbryoSlide™) may be the cause was disproven when standard culture dishes demonstrated no outcome difference in standard incubation. Though due to small patient numbers preliminary, this study raises concerns about the mostly uncontrolled introduction of closed incubation systems with time lapse imaging into routine clinical embryology. Appropriately designed and powered prospectively randomized studies appear urgently needed in well-defined patient populations before the uncontrolled utilization of these instruments further expands. NCT02246309 Registered September 18, 2014.

New Teacher Induction--In and out of Cyberspace

ERIC Educational Resources Information Center

Berry, Barnett; Byrd, Ann

2012-01-01

In this chapter, the authors draw on their experiences with working in building virtual communities of teachers and a pilot program to examine the prospects for increasing consistency in the effectiveness of new teacher support through online networks. Although not intended as a substitute for high-quality face-to-face mentoring experiences,…

Keewatin Region Educational Authority Pilot Adult Education Project: Computer-Assisted Learning. Final Report.

ERIC Educational Resources Information Center

Fahy, Patrick J.

This 2-year project attempted to improve local employment prospects of young adult Inuit in seven communities in the Keewatin Region in the Canadian Northwest Territories by providing them computer-assisted instruction (CAI) in adult basic education and high school equivalency upgrading programs; business, financial, and telecommunications…

Development and Feasibility of a COPD Self-Management Intervention Delivered with Motivational Interviewing Strategies

PubMed Central

Benzo, Roberto; Vickers, Kristin; Ernst, Denise; Tucker, Sharon; McEvoy, Charlene; Lorig, Kate

2013-01-01

BACKGROUND Self-management (SM) is proposed as the standard of care in chronic obstructive pulmonary disease (COPD) but details of the process and training required to deliver effective SM are not widely available. In addition, recent data suggest that patient engagement and motivation are critical ingredients for effective self-management. This manuscript carefully describes a self-management intervention using Motivational Interviewing skills, aimed to increase engagement and commitment in severe COPD patients. METHODS The intervention was developed and pilot tested for fidelity to protocol, for patient and interventionist feedback (qualitative) and effect on quality of life. Engagement between patient and interventionists was measured by the Working Alliance Inventory. The intervention was refined based in the results of the pilot study and delivered in the active arm of a prospective randomized study. RESULTS The pilot study suggested improvements in quality of life, fidelity to theory and patient acceptability. The refined self-management intervention was delivered 540 times in the active arm of a randomized study. We observed a retention rate of 86% (patients missing or not available for only 14% the scheduled encounters). CONCLUSIONS A self-management intervention, that includes motivational interviewing as the way if guiding patient into behavior change, is feasible in severe COPD and may increase patient engagement and commitment to self-management. This provides a very detailed description of the SM process for (the specifics of training and delivering the intervention) that facilitates replicability in other settings and could be translated to cardiac rehabilitation. PMID:23434613

Head and neck lymphedema management: Evaluation of a therapy program.

PubMed

Pigott, Amanda; Nixon, Jodie; Fleming, Jennifer; Porceddu, Sandro

2018-06-01

The purpose of this pilot study was to examine a therapeutic intervention for head and neck lymphedema. The 22-week intervention involved therapist-led care and participant self-management. Effectiveness was evaluated using a previously described lymphedema assessment tool, the Assessment of Lymphedema of the Head and Neck (ALOHA) to detect change over the course of the 22 weeks of treatment, and before and after a single treatment session. A prospective observational pilot study was conducted with a cohort of 10 participants assessed. Measurements of size (tape measurements) and water content (tissue dielectric constant [TDC]) were used, per the ALOHA protocol. Participants received 13 lymphedema therapy treatments at reducing frequencies over 22 weeks and daily self-management. There was an overall significant reduction in lower neck circumference (F [2.15,19.35] = 7.11; P = .004), upper neck circumference (F [5,45] = 7.27; P < .001) and TDC (F (5,45) = 8.92; P < .001) over time. There were no significant differences over the course of treatment for mean ear-to-ear measurements or before and after a single session of treatment. This pilot study found a reduction in head and neck lymphedema over the 22-week lymphedema treatment course. This intervention may be successful in reducing head and neck lymphedema; however, further studies are needed to investigate these findings in a larger sample with the use of a control group to negate improvements from healing over time. © 2018 Wiley Periodicals, Inc.

QRS analysis using wavelet transformation for the prediction of response to cardiac resynchronization therapy: a prospective pilot study.

PubMed

Vassilikos, Vassilios P; Mantziari, Lilian; Dakos, Georgios; Kamperidis, Vasileios; Chouvarda, Ioanna; Chatzizisis, Yiannis S; Kalpidis, Panagiotis; Theofilogiannakos, Efstratios; Paraskevaidis, Stelios; Karvounis, Haralambos; Mochlas, Sotirios; Maglaveras, Nikolaos; Styliadis, Ioannis H

2014-01-01

Wider QRS and left bundle branch block morphology are related to response to cardiac resynchronization therapy (CRT). A novel time-frequency analysis of the QRS complex may provide additional information in predicting response to CRT. Signal-averaged electrocardiograms were prospectively recorded, before CRT, in orthogonal leads and QRS decomposition in three frequency bands was performed using the Morlet wavelet transformation. Thirty eight patients (age 65±10years, 31 males) were studied. CRT responders (n=28) had wider baseline QRS compared to non-responders and lower QRS energies in all frequency bands. The combination of QRS duration and mean energy in the high frequency band had the best predicting ability (AUC 0.833, 95%CI 0.705-0.962, p=0.002) followed by the maximum energy in the high frequency band (AUC 0.811, 95%CI 0.663-0.960, p=0.004). Wavelet transformation of the QRS complex is useful in predicting response to CRT. © 2013.

A prospective health impact assessment of the international astronomy and space exploration centre

PubMed Central

Winters, L

2001-01-01

STUDY OBJECTIVES—Assess the potential health impacts of the proposed International Astronomy and Space Exploration Centre on the population of New Wallasey. Contribute to the piloting of health impact assessment methods.
DESIGN—Prospective health impact assessment involving brainstorming sessions and individual interviews with key informants and a literature review.
SETTING—New Wallasey Single Regeneration Budget 4 area.
PARTICIPANTS—Key stakeholders including local residents' groups selected through purposeful snowball sampling.
MAIN RESULTS—Recommendations are made that cover issues around: transport and traffic; civic design; security; public safety, employment and training.
CONCLUSIONS—Health impact assessment is a useful pragmatic tool for facilitating wide consultation. In particular engaging the local population in the early planning stages of a proposed development, and assisting in highlighting changes to maximise the positive health influences on affected communities.


Keywords: health impact assessment; health determinants PMID:11351002

Effects of an appointment reminder call on patient show rates.

PubMed

Gariti, P; Alterman, A I; Holub-Beyer, E; Volpicelli, J R; Prentice, N; O'Brien, C P

1995-01-01

A pilot study (N = 80) was conducted to determine if (1) prospective substance-dependent patients randomly selected to be reminded (TC) of their scheduled intake evaluation the day before their first appointment would have a higher show rate than those not contacted (NC); and (2) if TC subjects administered a satisfaction questionnaire 1-3 days after intake would exhibit higher treatment retention rates at one week and one month posttreatment entry than NC subjects not exposed to the questionnaire. The findings suggest that reminding prospective patients of their initial scheduled appointments and following up with phone calls to those who fail to show can improve the rate at which patients will initiate treatment, provided initial appointments are scheduled in a timely manner (7 days or less). Similarly, the combination of the reminder call and the satisfaction questionnaire were associated with higher treatment retention rates for those whose initial appointments were scheduled in a timely manner.

Suprapatellar Versus Infrapatellar Tibial Nail Insertion: A Prospective Randomized Control Pilot Study.

PubMed

Chan, Daniel S; Serrano-Riera, Rafael; Griffing, Rebecca; Steverson, Barbara; Infante, Anthony; Watson, David; Sagi, H Claude; Sanders, Roy W

2016-03-01

The purpose of this OTA-approved pilot study was to compare the clinical and functional outcomes of the knee joint after infrapatellar (IP) versus suprapatellar (SP) tibial nail insertion. Prospective, randomized. Level I trauma center. After institutional review board approval, skeletally mature patients with OTA 42 tibial shaft fractures were randomized into either an IP or SP nail insertion group after informed consent was obtained. The SP also underwent prenail and postnail insertion patella-femoral (PF) joint arthroscopy. Patients underwent follow-up (6 weeks, 3, 6, and 12 months) with standard radiographs, as well as visual analog score and pain diagram documentation. At the 6-month and 12-month visits, knee function questionnaires (Lysholm knee scale and SF-36) were completed. Magnetic resonance imaging/image (MRI) of the affected knee was obtained at 12 months. Ten patients in each group were required for a power analysis for the anticipated larger randomized control trial, but enrollment in each arm was not limited because of known problems with patient follow-up over a 12-month period. A total of 41 patients/fractures were enrolled in this study. Of those, only 25 patients/fractures (14 IP, 11 SP) fully complied with and completed 12 months of follow-up. Six of 11 SP presented with articular changes (chondromalacia) in the PF joint during the preinsertion arthroscopy. Three patients displayed a change in the articular cartilage based on postnail insertion arthroscopy. At 12 months, all fractures in both groups had proceeded to union. There were no differences between the affected and unaffected knee with respect to range of motion. Functional visual analog score and Lysholm knee scores showed no significant differences between groups (P > 0.05). The SF-36v2 comparison also revealed no significant differences in the overall score, all 4 mental components, and 3/4 physical components (P > 0.05). The bodily pain component score was superior in the SP group (45 vs. 36, P = 0.035). All 11 SP patients obtained MRIs at 1 year. Five of these patients had evidence of chondromalacia on MRI. These findings did not correlate with either the prenail or postnail insertion arthroscopy. Importantly, no patient in the SP group with postnail insertion arthroscopic changes had PF joint pain at 1 year. Overall, there seemed to be no significant differences in pain, disability, or knee range of motion between these 2 tibial intramedullary nail insertion techniques after 12 months of follow-up. Based on this pilot study data, larger prospective trial with long-term follow-up is warranted. Therapeutic Level II. See Instructions for Authors for a complete description of levels of evidence.

Frailty status as a predictor of three month cognitive and functional recovery following spinal surgery: a prospective pilot study.

PubMed

Rothrock, Robert J; Steinberger, Jeremy M; Badgery, Henry; Hecht, Andrew C; Cho, Samuel K; Caridi, John M; Deiner, Stacie

2018-05-21

Background Context As increasing numbers of elderly Americans undergo spinal surgery, it is important to identify which patients are at highest risk for poor cognitive and functional recovery. Frailty is a geriatric syndrome which has been closely linked to poor outcomes, and short form screening may be a helpful tool for preoperative identification of at risk patients. Purpose To conduct a pilot study on the usefulness of a short-form screening tool to identify elderly patients at increased risk for prolonged cognitive and functional recovery following elective spine surgery. Study Design/Setting Prospective, comparative cohort study. Patient Sample 100 patients over age 65 undergoing elective spinal surgery (cervical or lumbar) at a single, large academic medical center from 2013-2014. Outcome Measures FRAIL scale, Quality of Recovery Scale (PQRS), and Instrumental Activities (IADLs) scores. Methods Included patients were given the FRAIL scale and stratified as robust, pre-frail, or frail. Post-operative Quality of Recovery Scale (PQRS) and Instrumental Activities (IADLs) scores were also obtained. Patients were re-examined at 1 day, 3 days, 1 month, and 3 months after surgery for cognitive recovery at 3-months, and secondarily, functional recovery at 3-months. This study was funded in part by grants from the National Institute on Aging (K23-17-015, National Institutes of Health, Bethesda, Maryland, USA) and the American Federation for Aging Research (New York City, NY, USA). Results At 3-months, only 50% of frail patients had recovered to their cognitive baseline compared to 60.7% of pre-frail and 69.2% of robust patients (trend). At 3-months, 66.7% of frail patients had recovered to their functional baseline compared to 57% of pre-frail and 76.9% of robust patients (trend). Using multivariate regression modelling, at 3 months, frail patients were less likely to have recovered to their cognitive baseline compared to pre-frail and robust patients (OR 0.39, CI 0.131-1.161). Conclusions This pilot study demonstrates a trend towards poorer cognitive recovery 3-months following elective spinal surgery for frail patients. Frailty screening can help pre-operatively identify patients who may experience protracted cognitive and functional recovery. Copyright © 2018. Published by Elsevier Inc.

Teaching treatment planning for protons with educational open-source software: experience with FoCa and matRad.

PubMed

Sanchez-Parcerisa, Daniel; Udías, Jose

2018-05-12

Open-source, MATLAB-based treatment planning systems FoCa and matRAD were used in a pilot project for training prospective medical physicists and postgraduate physics students in treatment planning and beam modeling techniques for proton therapy. In the four exercises designed, students learnt how proton pencil beams are modeled and how dose is calculated in three-dimensional voxelized geometries, how pencil beam scanning plans (PBS) are constructed, the rationale behind the choice of spot spacing in patient plans, and the dosimetric differences between photon IMRT and proton PBS plans. Sixty students of two courses participated in the pilot project, with over 90% of satisfactory rating from student surveys. The pilot experience will certainly be continued. © 2018 The Authors. Journal of Applied Clinical Medical Physics published by Wiley Periodicals, Inc. on behalf of American Association of Physicists in Medicine.

Windmill-task as a New Quantitative and Objective Assessment for Mirror Movements in Unilateral Cerebral Palsy: A Pilot Study.

PubMed

Zielinski, Ingar Marie; Steenbergen, Bert; Schmidt, Anna; Klingels, Katrijn; Simon Martinez, Cristina; de Water, Pascal; Hoare, Brian

2018-03-23

To introduce the Windmill-task, a new objective assessment tool to quantify the presence of mirror movements (MMs) in children with unilateral cerebral palsy (UCP), which are typically assessed with the observation-based Woods and Teuber scale (W&T). Prospective, observational, cohort pilot study. Children's hospital. Prospective cohort of children (N=23) with UCP (age range, 6-15y, mean age, 10.5±2.7y). Not applicable. The concurrent validity of the Windmill-task is assessed, and the sensitivity and specificity for MM detection are compared between both assessments. To assess the concurrent validity, Windmill-task data are compared with W&T data using Spearman rank correlations (ρ) for 2 conditions: affected hand moving vs less affected hand moving. Sensitivity and specificity are compared by measuring the mean percentage of children being assessed inconsistently across both assessments. Outcomes of both assessments correlated significantly (affected hand moving: ρ=.520; P=.005; less affected hand moving: ρ=.488; P=.009). However, many children displayed MMs on the Windmill-task, but not on the W&T (sensitivity: affected hand moving: 27.5%; less affected hand moving: 40.6%). Only 2 children displayed MMs on the W&T, but not on the Windmill-task (specificity: affected hand moving: 2.9%; less affected hand moving: 1.4%). The Windmill-task seems to be a valid tool to assess MMs in children with UCP and has an additional advantage of sensitivity to detect MMs. Copyright © 2018 American Congress of Rehabilitation Medicine. Published by Elsevier Inc. All rights reserved.

A prospective study comparing tryptophan immunoadsorption with therapeutic plasma exchange for the treatment of chronic inflammatory demyelinating polyneuropathy.

PubMed

Lieker, Ina; Slowinski, Torsten; Harms, Lutz; Hahn, Katrin; Klehmet, Juliane

2017-12-01

Chronic inflammatory demyelinating polyneuropathy (CIDP) is a rare paralyzing inflammatory neuropathy with probably autoimmune origin. While plasma exchange (PE) constitutes a first-line treatment option for CIDP, there is only little known about the efficacy and safety of immunoadsorption (IA), a more selective apheresis procedure with assumed better tolerability. In this prospective-randomized pilot trial, patients were randomly assigned to receive 6 sessions of PE (n = 10) or IA (n = 10) treating equal plasma volumes. To evaluate efficacy, we calculated the adjusted Inflammatory Neuropathy Cause and Treatment (INCAT) disability score and the Medical Research Council (MRC) sum score at baseline (V1), after completion of 6 sessions (V2) as well as 4 weeks after completion (V3) in 9 patients per group (1 patient in each group did not complete follow-up). We additionally assessed safety and tolerability of treatments by monitoring adverse event and blood parameters. With IA, 6 out of 9 (66.7%) patients improved clinically, whereas with PE, 4 out of 9 (44.4%) patients improved, most of them immediately with completion of the apheresis treatment series. There was one adverse event (AE) out of 52 treatment sessions for the 9 patients in the IA group. In the PE group of 9 patients, there was 1 AE out of 51 sessions and a trend of greater fibrinogen reduction. No severe AE occurred in either group. The results of this pilot study suggest that IA is at least equally effective and safe compared to PE in CIDP patients. © 2017 Wiley Periodicals, Inc.

The influence of mandibular third molar germectomy on the treatment time of impacted mandibular second molars using brass wire: a prospective clinical pilot study.

PubMed

Cassetta, M; Altieri, F

2017-07-01

The brass wire ligature is an efficient method to correct a moderately mesially impacted mandibular second molar (MM2). The aim of this prospective clinical pilot study was to evaluate the influence of mandibular third molar (MM3) germectomy on the treatment time for this procedure and to determine its impact on oral health-related quality of life (OHRQoL) using the short-form Oral Health Impact Profile (OHIP-14). The STROBE guidelines were followed. Impacted MM2 were assigned randomly to receive brass wire ligature treatment either with germectomy (group A) or without germectomy (group B). Descriptive statistics and the Student t-test were used in the statistical analysis; significance was set at P≤0.05. One thousand and thirty patients were assessed. Fourteen subjects with 20 mesially angulated (range 25-40°) impacted MM2 were identified. Paired comparisons of groups A and B showed no statistically significant difference in treatment time (171days for group A and 174days for group B; P=0.440), but a statistically significant difference in OHIP-14 values at the 3- (P=0.017) and 7-day (P=0.002) follow-up. The brass wire technique can be used effectively in moderately impacted MM2, but the combined use of MM3 germectomy does not influence the treatment time and shows a negative impact on OHRQoL. Copyright © 2017 International Association of Oral and Maxillofacial Surgeons. Published by Elsevier Ltd. All rights reserved.

Correlation between the Efficacy of Lamotrigine and the Serum Lamotrigine Level during the Remission Phase of Acute Bipolar II Depression: A Naturalistic and Unblinded Prospective Pilot Study.

PubMed

Kikkawa, Akiyoshi; Kitamura, Yoshihisa; Aiba, Tetsuya; Hiraki, Koichi; Sendo, Toshiaki

2017-01-01

Lamotrigine has acute antidepressant effects in patients with bipolar disorder. However, there is little information regarding appropriate serum levels of lamotrigine and the time until remission after the start of lamotrigine therapy in patients with bipolar II depression. This was a naturalistic and unblinded prospective pilot study. Twelve patients' depressive symptoms were evaluated using the Montgomery-Åsberg Depression Rating Scale (MADRS) at the start of treatment and at the time of remission, and blood samples were obtained at the time of remission. Mahalanobis distance was used to analyze the relationship between the MADRS improvement rate and the serum lamotrigine level. Furthermore, we calculated the Spearman's rank correlation coefficient for the relationship between the MADRS improvement rate and the serum lamotrigine level, and produced box plots of the serum lamotrigine level at remission and the time until remission. The Mahalanobis distance for the patient that was co-administered lamotrigine and valproic acid differed significantly from those of the other patients (p<0.001). There was no linear relationship between the serum lamotrigine level and the MADRS improvement rate among the patients that did not receive valproic acid. The median time from the start of lamotrigine therapy until remission was 6 weeks. The serum lamotrigine level does not have an important impact on the acute therapeutic effects of lamotrigine on bipolar II depression. In addition, we consider that different treatment options should be considered for non-responders who do not exhibit any improvement after the administration of lamotrigine for approximately 6 weeks.

[Water immersion as an anti-g protection for pilot. Pro et contra].

PubMed

Barer, A S

2007-01-01

In the period of 1988 - 1990 the ZVEZDA Aerospace medicine Department fulfilled comprehensive physiological investigations in order to assess the prospects for water immersion as an anti-g gear for pilots of high-maneuver aircraft. Both dry and open water immersion methods were used. More than 150 centrifuge runs were conducted to define limits for the acceleration value and time of 9-g tolerance. Volunteered subjects in the pilot's posture were inclined at 35 degrees and 55 degrees to the total inertial force vector. The obvious subjective discomfort felt during acceleration and absence of clinical aftereffect were qualified as a positive outcome. The subjects were ready for repeated runs even after a very brief repose. The main impediment to the professional anti-g use of immersion is visual disorders which in this case are not predictors of coming loss of consciousness and attributed to alterations in regional hemodynamics. The authors assert that there is a good reason to continue search for implementation of the immersion principle in g-protection of pilots to reduce the rate of professional pathologies and to intensify flights.

[Efficacy of Arnica in varicose vein surgery: results of a randomized, double-blind, placebo-controlled pilot study].

PubMed

Wolf, M; Tamaschke, C; Mayer, W; Heger, M

2003-10-01

In homeopathy ARNICA is widely used as a woundhealing medication and for the treatment of hematomas. In this pilot study the efficacy and safety of ARNICA D12 in patients following varicose vein surgery were investigated. Prospective, randomized, double-blind, placebo-controlled pilot trial according to ICH GCP guidelines. The study was conducted by a surgeon at the Angiosurgical Clinic, Berlin- Buch. After randomized allocation, 60 patients received either ARNICA D12 or placebo. Start of medication occurred the evening before operation with 5 globules. On the operation day one preoperative and hourly postoperative dosages after awakening were given. On days 2-14 of the study 5 globules 3 times a day were given. OUTCOME CRITERIA: Surface (in cm(2) and using a three-point verbal rating scale) and intensity of hematomas induced by operation, complications of wound healing, and intensity of pain (five-point verbal rating scale) as well as efficacy and safety of the study medication were assessed. Hematoma surface was reduced (from day 7 to day 14) under ARNICA by 75.5% and under placebo by 71.5% (p = 0.4726). The comparison of hematoma surface (small, medium, large) using the verbal rating scale yielded a value of p = 0.1260. Pain score decreased by 1.0 +/- 2.2 points under ARNICA and 0.3 +/- 0.8 points under placebo (p = 0.1977). Remission or improvement of pain was observed in 43.3% of patients in the ARNICA group and in 27.6% of patients in the placebo group. Tolerability was rated as very good in all cases. The results of this pilot study showed a trend towards a beneficial effect of ARNICA D12 with regard to reduction of hematoma and pain during the postoperative course. For a statistically significant proof of efficacy of ARNICA D12 in patients following varicose vein surgery a larger sample size is necessary. Copyright 2003 S. Karger GmbH, Freiburg

Taking the first step towards entrenching mental health in the workplace: insights from a pilot study among HR personnel in Nigeria.

PubMed

Atilola, O; Akinyemi, O; Atilola, B

2014-01-01

The continued relevance of optimal employee mental health to sustainable human capital development in the workplace underscores the need to start harnessing all resources that can be mobilized to promote the entrenchment of workplace mental health. The strategic place of workplace Human Resource (HR) units in formulating and implementing workplace welfare schemes makes them potential partners. To actualize this, it is important to initially assess the preparedness of HR personnel for, and the possible barriers to entrenching mental health in the workplace. To suggest the initial course of action and to serve as a template for a robust large-scale study, we conduct a pilot assessment of the experience with, attitudes towards, and level of prioritization of mental health in the workplace among a cohort of HR personnel in Nigeria. Participants were recruited in the course of a seminar/workshop and questionnaires were developed by authors to assess variables of interest. Attitudes were examined using an adapted form of the Link's Discrimination-Devaluation (LD-D) scale. A total of 90 human-resource personnel completed the questionnaires. Only 16% of the participants reported having handled the case of an employee with a suspected mental health problem in the preceding 2 years. Attitudes toward employees and prospective employees with mental illness were largely poor. For instance, more than 70% were likely to consider for employment someone with a pre-existing physical disability than for someone with a history of mental illness. In terms of workplace health promotion priorities, physical health seminars took wide precedence over mental health seminars. The preliminary findings of this pilot study justify a need to conduct a large scale study. Significant challenges encountered in the course of this pilot study were highlighted while insights were drawn for the conduct of the main study/project.

PHARMacy-based interdisciplinary program for patients with Chronic Heart Failure (PHARM-CHF): rationale and design of a randomized controlled trial, and results of the pilot study.

PubMed

Laufs, Ulrich; Griese-Mammen, Nina; Krueger, Katrin; Wachter, Angelika; Anker, Stefan D; Koehler, Friedrich; Rettig-Ewen, Volker; Botermann, Lea; Strauch, Dorothea; Trenk, Dietmar; Böhm, Michael; Schulz, Martin

2018-05-30

We report the rationale and design of a community PHARMacy-based prospective randomized controlled interdisciplinary study for ambulatory patients with Chronic Heart Failure (PHARM-CHF) and results of its pilot study. The pilot study randomized 50 patients to a pharmacy-based intervention or usual care for 12 months. It demonstrated the feasibility of the design and showed reduced systolic blood pressure in the intervention group as indicator for improved medication adherence. The main study will randomize patients ≥60 years on stable pharmacotherapy including at least one diuretic and a history of heart failure hospitalization within 12 months. The intervention group will receive a medication review at baseline followed by regular dose dispensing of the medication, counselling regarding medication use and symptoms of heart failure. The control patients are unknown to the pharmacy and receive usual care. The primary efficacy endpoint is medication adherence, pre-specified as a significant difference of the proportion of days covered between the intervention and control group within 365 days following randomization using pharmacy claims data for three CHF medications (angiotensin-converting enzyme inhibitors or angiotensin receptor blockers, beta-blockers, and mineralocorticoid receptor antagonists). The primary composite safety endpoint is days lost due to blindly adjudicated unplanned cardiovascular hospitalizations or death. Overall, 248 patients shall be randomized. The minimum follow-up is 12 months with an expected mean of 24 months. Based on the feasibility demonstrated in the pilot study, the randomized PHARM-CHF trial will test whether an interdisciplinary pharmacy-based intervention can safely improve medication adherence and will estimate the potential impact on clinical endpoints. ClinicalTrials.gov Identifier: NCT01692119. © 2018 The Authors. European Journal of Heart Failure © 2018 European Society of Cardiology.

A framework for prospectively defining progression rules for internal pilot studies monitoring recruitment.

PubMed

Hampson, Lisa V; Williamson, Paula R; Wilby, Martin J; Jaki, Thomas

2017-01-01

Just over half of publicly funded trials recruit their target sample size within the planned study duration. When recruitment targets are missed, the funder of a trial is faced with the decision of either committing further resources to the study or risk that a worthwhile treatment effect may be missed by an underpowered final analysis. To avoid this challenging situation, when there is insufficient prior evidence to support predicted recruitment rates, funders now require feasibility assessments to be performed in the early stages of trials. Progression criteria are usually specified and agreed with the funder ahead of time. To date, however, the progression rules used are typically ad hoc. In addition, rules routinely permit adaptations to recruitment strategies but do not stipulate criteria for evaluating their effectiveness. In this paper, we develop a framework for planning and designing internal pilot studies which permit a trial to be stopped early if recruitment is disappointing or to continue to full recruitment if enrolment during the feasibility phase is adequate. This framework enables a progression rule to be pre-specified and agreed upon prior to starting a trial. The novel two-stage designs stipulate that if neither of these situations arises, adaptations to recruitment should be made and subsequently evaluated to establish whether they have been successful. We derive optimal progression rules for internal pilot studies which minimise the expected trial overrun and maintain a high probability of completing the study when the recruitment rate is adequate. The advantages of this procedure are illustrated using a real trial example.

A prospective pilot study on early toxicity from a simultaneously integrated boost technique for canine sinonasal tumours using image-guided intensity-modulated radiation therapy.

PubMed

Soukup, A; Meier, V; Pot, S; Voelter, K; Rohrer Bley, C

2018-05-14

In order to overcome the common local treatment failure of canine sinonasal tumours, integrated boost techniques were tried in the cobalt/orthovoltage era, but dismissed because of unacceptable early (acute) toxicity. Intriguingly, a recent calculation study of a simultaneously integrated boost (SIB) technique for sinonasal irradiation using intensity-modulated radiation therapy (IMRT) predicted theoretical feasibility. In this prospective pilot study we applied a commonly used protocol of 10 × 4.2 Gy to the planning target volume (PTV) with a 20%-SIB dose to the gross tumour volume (GTV). Our hypothesis expected this dose escalation to be clinically tolerable if applied with image-guided IMRT. We included 9 dogs diagnosed with sinonasal tumours without local/distant metastases. For treatment planning, organs at risk were contoured according to strict anatomical guidelines. Planning volume extensions (GTV/CTV/PTV) were standardized to minimize interplanner variability. Treatments were applied with rigid patient positioning and verified daily with image guidance. After radiation therapy, we set focus on early ophthalmologic complications as well as mucosal and cutaneous toxicity. Early toxicity was evaluated at week 1, 2, 3, 8 and 12 after radiotherapy. Only mild ophthalmologic complications were found. Three patients (33%) had self-limiting moderate to severe early toxicity (grade 3 mucositis) which was managed medically. No patient developed ulcerations/haemorrhage/necrosis of skin/mucosa. The SIB protocol applied with image-guided IMRT to treat canine sinonasal tumours led to clinically acceptable side effects. The suspected increased tumour control probability and the risk of late toxicity with the used dose escalation of 20% has to be further investigated. © 2018 John Wiley & Sons Ltd.

PROSPECTIVE COMPARISON OF TUMOR STAGING USING COMPUTED TOMOGRAPHY VERSUS MAGNETIC RESONANCE IMAGING FINDINGS IN DOGS WITH NASAL NEOPLASIA: A PILOT STUDY.

PubMed

Lux, Cassie N; Culp, William T N; Johnson, Lynelle R; Kent, Michael; Mayhew, Philipp; Daniaux, Lise A; Carr, Alaina; Puchalski, Sarah

2017-05-01

Identification of nasal neoplasia extension and tumor staging in dogs is most commonly performed using computed tomography (CT), however magnetic resonance imaging (MRI) is routinely used in human medicine. A prospective pilot study enrolling six dogs with nasal neoplasia was performed with CT and MRI studies acquired under the same anesthetic episode. Interobserver comparison and comparison between the two imaging modalities with regard to bidimensional measurements of the nasal tumors, tumor staging using historical schemes, and assignment of an ordinal scale of tumor margin clarity at the tumor-soft tissue interface were performed. The hypotheses included that MRI would have greater tumor measurements, result in higher tumor staging, and more clearly define the tumor soft tissue interface when compared to CT. Evaluation of bone involvement of the nasal cavity and head showed a high level of agreement between CT and MRI. Estimation of tumor volume using bidimensional measurements was higher on MRI imaging in 5/6 dogs, and resulted in a median tumor volume which was 18.4% higher than CT imaging. Disagreement between CT and MRI was noted with meningeal enhancement, in which two dogs were positive for meningeal enhancement on MRI and negative on CT. One of six dogs had a higher tumor stage on MRI compared to CT, while the remaining five agreed. Magnetic resonance imaging resulted in larger bidimensional measurements and tumor volume estimates, along with a higher likelihood of identifying meningeal enhancement when compared to CT imaging. Magnetic resonance imaging may provide integral information for tumor staging, prognosis, and treatment planning. © 2017 American College of Veterinary Radiology.

Assessment of Synthetic Glue for Mesh Attachment in Laparoscopic Sacrocolpopexy: A Prospective Multicenter Pilot Study.

PubMed

Lamblin, Gery; Dubernard, Gil; de Saint Hilaire, Pierre; Jacquot, Franck; Chabert, Philippe; Chene, Gautier; Golfier, François

2017-01-01

To assess the anatomic efficacy and safety of synthetic glue to fix prosthetic material in laparoscopic sacrocolpopexy. A 1-year follow-up in a prospective multicenter pilot study between November 2013 and November 2014 (Canadian Task Force Classification II-2). An academic urogynecology research hospital. Seventy consecutive patients with Pelvic Organ Prolapse Quantification stage ≥3 anterior and/or medial prolapse underwent laparoscopic sacrocolpopexy. All women underwent laparoscopic sacrocolpopexy with the same standardized technique using a synthetic surgical glue to fix anterior and posterior meshes. Patients were followed up at 1 month and 1 year, with anatomic and functional assessment (Pelvic Floor Distress Inventory-20, Pelvic Floor Impact Questionnaire-7, and Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire-12). Anatomic success was defined as 1-year Pelvic Organ Prolapse Quantification stage ≤1. Sixty-six patients were included; the mean age was 56.7 ± 1.2 years. The mean operative time was 145 ± 5 minutes. The mean glue fixation time was less than 2 minutes for both anterior and posterior meshes. The 1-year anatomic success rate was 87.5% in the anterior compartment (Ba at -2.3 cm, p < .0001) and 95.3% in the medial compartment (point C at -6.1 cm, p < .0001). There were no intra- or postoperative complications and no cases of mesh exposure; 5 cases of mesh shrinkage (7.8%) were observed at 1 year. The postoperative urinary stress incontinence rate was 29.7% at 1 year. Eight patients (12.1%) underwent revision surgery with transobturator tape. All quality of life scores showed significant improvement (p < .0001) at 1 year. Synthetic glue attachment of prosthetic material in laparoscopic sacrocolpopexy proved straightforward, safe, time-saving, and effective at 1 year. Prospective randomized studies will be needed to confirm the long-term benefit. Copyright © 2016 AAGL. Published by Elsevier Inc. All rights reserved.

Physical activity and lung cancer among non-smokers: A pilot molecular epidemiologic study within EPIC

PubMed Central

RUNDLE, ANDREW; RICHIE, JOHN; STEINDORF, KAREN; PELUSO, MARCO; OVERVAD, KIM; RAASCHOU-NIELSEN, OLE; CLAVEL-CHAPELON, FRANCOISE; LINSEISEN, JACOB P.; BOEING, HEINER; TRICHOPOULOU, ANTONIA; PALLI, DOMENICO; KROGH, VITTORIO; TUMINO, ROSARIO; PANICO, SALVATORE; BUENO-DE-MESQUITA, HENDRIK B.; PEETERS, PETRA H.; LUND, EILIV; GONZALEZ, CARLOS A.; MARTINEZ, CARMEN; DORRONSORO, MIREN; BARRICARTE, AURELIO; TORMO, M. JOSE; QUIROS, JOSÈ R.; AGUDO, ANTONIO; BERGLUND, GORAN; JARVHOLM, BENGT; BINGHAM, SHEILA; KEY, TIMOTHY J.; GORMALLY, EMMANUELLE; SARACCI, RODOLFO; KAAKS, RUDOLF; RIBOLI, ELIO; VINEIS, PAOLO

2013-01-01

The association between physical activity, potential intermediate biomarkers and lung cancer risk was investigated in a study of 230 cases and 648 controls nested within the European Prospective Investigation of Cancer and Nutrition. Data on white blood cell aromatic-DNA adducts by 32P-postlabeling and glutathione (GSH) in red blood cells were available from a subset of cases and controls. Compared to the first quartile, the fourth quartile of recreational physical activity was associated with lower lung cancer risk [odds ratio=0.56 (0.35–0.90)], higher GSH levels [+1.87 micro mole GSH/gram haemoglobin, p=0.04] but not with the presence of high levels of adducts [odds ratio=1.05 (0.38–2.86)]. Despite being associated with recreational physical activity, in these small scale pilot analyses GSH levels were not associated with lung cancer risk, [odds ratio=0.95 (0.84 – 1.07) per unit increase in glutathione levels]. Household and occupational activity was not associated with lung cancer risk or biomarker levels. PMID:20050820

Efficacy and tolerability of bromelain in patients with chronic rhinosinusitis--a pilot study.

PubMed

Büttner, L; Achilles, N; Böhm, M; Shah-Hosseini, K; Mösges, R

2013-01-01

To evaluate the efficacy, tolerability, and impact on quality of life (QoL) of bromelain tablets (500 FIP) in patients with chronic rhinosinusitis (CRS). In this prospective, open-label observational pilot study, 12 patients suffering from CRS with (CRS+NP) or without (CRS-NP) nasal polyps who had undergone prior sinus surgery were treated with bromelain tablets (500 FIP) for three months. Efficacy was evaluated using symptom scores (Total Symptom Scores: TSS); a Total Rhinoscopy Score (TRS) was also determined. QoL was assessed by using the German, adapted version of the Sinonasal Outcome Test 20 (SNOT-20 GAV). Treatment with bromelain tablets (500 FIP) improved TSS, TRS and SNOT-20 GAV on average. This treatment was found to be more effective, however, for CRS-NP than for CRS+NP. The average intake was six tablets, equivalent to a daily dosage of 3000 FIP. No adverse events were observed. Preliminary results indicate good tolerability, symptom control, and improvement in QoL for the treatment of CRS using bromelain tablets (500 FIP).

PRIMARY IMMUNE DEFICIENCY TREATMENT CONSORTIUM (PIDTC) UPDATE

PubMed Central

Griffith, Linda M.; Cowan, Morton J.; Notarangelo, Luigi D.; Kohn, Donald B.; Puck, Jennifer M.; Shearer, William T.; Burroughs, Lauri M.; Torgerson, Troy R.; Decaluwe, Hélène; Haddad, Elie

2016-01-01

The Primary Immune Deficiency Treatment Consortium (PIDTC) is a collaboration of 41 North American centers studying therapy for rare primary immune deficiency diseases (PID) including Severe Combined Immune Deficiency (SCID), Wiskott-Aldrich syndrome (WAS) and chronic granulomatous disease (CGD). An additional 3 European centers have partnered with the PIDTC to study CGD. Natural history protocols of the PIDTC analyze outcomes of treatment for rare PID in multicenter longitudinal retrospective, prospective and cross-sectional studies. Since 2009, participating centers have enrolled over 800 subjects on PIDTC protocols for SCID, and enrollment on the studies in WAS and CGD is underway. Four pilot projects have been funded and 12 junior investigators have received fellowship awards. Important publications of the consortium describe outcomes of hematopoietic cell transplantation (HCT) for SCID during 2000–2009, diagnostic criteria for SCID, and the pilot project of newborn screening (NBS) for SCID in the Navajo Nation. The PIDTC Annual Scientific Workshops provide an opportunity to strengthen collaborations with junior investigators, patient advocacy groups and international colleagues. Funded by the NIAID and ORDR, NCATS, the PIDTC has recently received renewal for another 5 years. Here, we review accomplishments of the group, projects underway, highlights of recent workshops and challenges for the future. PMID:27262745

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

PubMed

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

2017-08-01

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

Acupuncture in shoulder pain and functional impairment after neck dissection: A prospective randomized pilot study.

PubMed

Deganello, Alberto; Battat, Nir; Muratori, Enrico; Cristofaro, Glauco; Buongiorno, Ana; Mannelli, Giuditta; Picconi, Mario; Giachetti, Rita; Borsotti, Giulia; Gallo, Oreste

2016-08-01

The efficacy of conventional physiotherapy and antiinflammatory/analgesic drugs in the management of shoulder pain and functional disability following neck dissection is often disappointing. Acupuncture is a safe and well-tolerated method. We report the results regarding our pilot trial of acupuncture versus conventional care in the management of postoperative shoulder pain and dysfunction after neck dissection. Pilot study. Patients at a tertiary university center with chronic pain or dysfunction attributed to neck dissection were randomly assigned to either weekly acupuncture or usual care (eg., physical therapy, analgesia, and/or antiinflammatory drugs) for 5 consecutive weeks. The Constant-Murley score, a composite measure of pain, function, and activities of daily living, was the primary outcome measure. As secondary end point, The Neck Dissection Impairment Index (NDII) was used to quantify site-specific, self-reported quality of life (QOL). After randomization, 48 patients completed the study (23 and 25 patients on acupuncture and control arms, respectively). Constant-Murley scores improved more in the acupuncture group (gain difference between groups 13.6, P < 0.01), a statistically significant improvement in site-specific QOL was also recorded at NDII (gain difference between groups 11.5, P < 0.01). Acupuncture is safe and effective; it should be introduced and offered to patients suffering from neck pain and dysfunction related to neck dissection. 2b. Laryngoscope, 126:1790-1795, 2016. © 2016 The American Laryngological, Rhinological and Otological Society, Inc.

Teaching Evaluation of Higher Education Institutions: Retrospect and Prospect

ERIC Educational Resources Information Center

Siping, Gao

2009-01-01

China started up pilot projects for the evaluation of teaching work at regular higher education institutions (HEIs) in 1994, and, beginning in 2003, the Ministry of Education (MOE) formally set up a system of cyclical teaching evaluation. Among the 592 undergraduate colleges and universities that were listed in the plan for the first round of…

The usefulness of school-based syndromic surveillance for detecting malaria epidemics: experiences from a pilot project in Ethiopia.

PubMed

Ashton, Ruth A; Kefyalew, Takele; Batisso, Esey; Awano, Tessema; Kebede, Zelalem; Tesfaye, Gezahegn; Mesele, Tamiru; Chibsa, Sheleme; Reithinger, Richard; Brooker, Simon J

2016-01-09

Syndromic surveillance is a supplementary approach to routine surveillance, using pre-diagnostic and non-clinical surrogate data to identify possible infectious disease outbreaks. To date, syndromic surveillance has primarily been used in high-income countries for diseases such as influenza--however, the approach may also be relevant to resource-poor settings. This study investigated the potential for monitoring school absenteeism and febrile illness, as part of a school-based surveillance system to identify localised malaria epidemics in Ethiopia. Repeated cross-sectional school- and community-based surveys were conducted in six epidemic-prone districts in southern Ethiopia during the 2012 minor malaria transmission season to characterise prospective surrogate and syndromic indicators of malaria burden. Changes in these indicators over the transmission season were compared to standard indicators of malaria (clinical and confirmed cases) at proximal health facilities. Subsequently, two pilot surveillance systems were implemented, each at ten sites throughout the peak transmission season. Indicators piloted were school attendance recorded by teachers, or child-reported recent absenteeism from school and reported febrile illness. Lack of seasonal increase in malaria burden limited the ability to evaluate sensitivity of the piloted syndromic surveillance systems compared to existing surveillance at health facilities. Weekly absenteeism was easily calculated by school staff using existing attendance registers, while syndromic indicators were more challenging to collect weekly from schoolchildren. In this setting, enrolment of school-aged children was found to be low, at 54%. Non-enrolment was associated with low household wealth, lack of parental education, household size, and distance from school. School absenteeism is a plausible simple indicator of unusual health events within a community, such as malaria epidemics, but the sensitivity of an absenteeism-based surveillance system to detect epidemics could not be rigorously evaluated in this study. Further piloting during a demonstrated increase in malaria transmission within a community is recommended.

Petroleum contaminated water and health symptoms: a cross-sectional pilot study in a rural Nigerian community.

PubMed

Kponee, Kalé Zainab; Chiger, Andrea; Kakulu, Iyenemi Ibimina; Vorhees, Donna; Heiger-Bernays, Wendy

2015-11-06

The oil-rich Niger Delta suffers from extensive petroleum contamination. A pilot study was conducted in the region of Ogoniland where one community, Ogale, has drinking water wells highly contaminated with a refined oil product. In a 2011 study, the United Nations Environment Programme (UNEP) sampled Ogale drinking water wells and detected numerous petroleum hydrocarbons, including benzene at concentrations as much as 1800 times higher than the USEPA drinking water standard. UNEP recommended immediate provision of clean drinking water, medical surveillance, and a prospective cohort study. Although the Nigerian government has provided emergency drinking water, other UNEP recommendations have not been implemented. We aimed to (i) follow up on UNEP recommendations by investigating health symptoms associated with exposure to contaminated water; and (ii) assess the adequacy and utilization of the government-supplied emergency drinking water. We recruited 200 participants from Ogale and a reference community, Eteo, and administered questionnaires to investigate water use, perceived water safety, and self-reported health symptoms. Our multivariate regression analyses show statistically significant associations between exposure to Ogale drinking water and self-reported health symptoms consistent with petroleum exposure. Participants in Ogale more frequently reported health symptoms related to neurological effects (OR = 2.8), hematological effects (OR = 3.3), and irritation (OR = 2.7). Our results are the first from a community relying on drinking water with such extremely high concentrations of benzene and other hydrocarbons. The ongoing exposure and these pilot study results highlight the need for more refined investigation as recommended by UNEP.

Three-dimensional Imaging of High-resolution Computer Tomography of Singers' Larynges-A Pilot Study.

PubMed

Vorik, Alexandra; Unteregger, Fabian; Zwicky, Salome; Schiwowa, Julia; Potthast, Silke; Storck, Claudio

2017-01-01

Biplanar imaging technique is not sufficient for an exact visualization and evaluation of the laryngeal biomechanics during speaking or singing. The aim of this pilot study was to test a 3D-visualization software MIMICS (Materialize Interactive Medical Image Control System, Materialize, Leuven, Belgium) for visualizing laryngeal cartilages and resonance space of living humans during singing based on high-resolution computed tomography (HRCT) and analyzing the biomechanics thereof. This is a prospective pilot study. A total of 10 professional female singers (five sopranos and five altos) was scanned with HRCT in three singing positions fundamental frequency (ƒo), first octave (ƒo+1 8va) and second octave (ƒo+2 8va). All relevant laryngeal structures and resonance space could be 3D visualized. Superimposing the different HRCT scans showed an inward rotation and rocking of the arytenoid cartilages from ƒo+1 8va to ƒo+2 8va and a backward tilting of the cricoid cartilage from ƒo+1 8va to ƒo+2 8va. Moreover, we could demonstrate a vocal fold elongation of 13% from ƒo to ƒo+1 8va and an additional elongation from ƒo+1 8va to ƒo+2 8va of 10% in type A cricothyroid joints (CTJ) A and 4% in CTJ's type B/C. There were no significant differences between sopranos and altos in all parameters (length of the glottis, subglottic diameter, distance between anterior commissure and cervical spine, and CTJ distribution). This noninvasive 3D-visualization technique with MIMICS allows the anatomical structures and landmarks of the larynx to be analyzed. We believe that this pilot study will serve as a basis for further biomechanical studies on speakers' and singers' larynges. Copyright © 2017 The Voice Foundation. Published by Elsevier Inc. All rights reserved.

HOSPITAL-BASED HEALTH TECHNOLOGY ASSESSMENT FOR THE ADOPTION OF INNOVATIVE MEDICAL DEVICES WITHIN FRENCH HOSPITALS: OPPORTUNITIES AND CHALLENGES FOR INDUSTRY.

PubMed

Dutot, Camille; Mercier, Grégoire; Borget, Isabelle; de Sauvebeuf, Côme; Martelli, Nicolas

2017-01-01

Within French university hospitals, some internal committees are in charge of conducting hospital-based health technology assessment (Hb-HTA) to support managerial decisions regarding the adoption of innovations. For manufacturers, hospitals are usually the entry point for new and innovative medical devices, which cannot be accessed without the Hb-HTA committees' approval. Thus, the main objective of this pilot survey was to explore manufacturers' insights into Hb-HTA processes. A two-step pilot survey was conducted in 2014. First, semi-structured phone interviews were carried out to capture manufacturers' feedback on the Hb-HTA procedure. Second, a prospective and iterative questionnaire designed to explore manufacturers' market access strategies was administered. Eight manufacturers from the medical device industry completed the retrospective phone interviews, and five of them participated in the prospective survey. According to the overall feedback, the Hb-HTA process timeline and transparency are major issues, and the expectations of internal committees, especially in terms of clinical evidence, remain difficult to understand. However, despite this and due to the complexity of reimbursement processes at the national level, manufacturers are increasingly considering hospital adoption through Hb-HTA submission as a viable market access and coverage opportunity. Our study reaffirms the primary role of hospitals in the diffusion of innovative medical devices. However, to ensure efficient and broad access to innovation, cooperation between local and national HTA bodies is critical and should be promoted.

A pilot study on the randomization of inferior vena cava filter placement for venous thromboembolism prophylaxis in high-risk trauma patients.

PubMed

Rajasekhar, Anita; Lottenberg, Lawrence; Lottenberg, Richard; Feezor, Robert J; Armen, Scott B; Liu, Huazhi; Efron, Philip A; Crowther, Mark; Ang, Darwin

2011-08-01

Placement of prophylactic inferior vena cava filters (pIVCFs) for the prevention of pulmonary embolism (PE) in high-risk trauma patients (HRTPs) are widely practiced despite the lack of Level I data supporting this use. We report the 2-year interim analysis of the Filters in Trauma pilot study. This is a single institution, prospective randomized controlled pilot feasibility study in a Level I trauma center. HRTPs were identified for pIVCF placement by the Eastern Association for the Surgery of Trauma guidelines. From November 2008 to November 2010, HRTPs were enrolled and randomized to either pIVCF or no pIVCF. All patients received pharmacologic prophylaxis when safe. Primary outcomes included feasibility objectives and secondary outcomes were incidence of PE, deep vein thrombosis (DVT), and death. Thirty-four of 38 enrolled patients were eligible for analysis. The baseline sociodemographic characteristics were balanced between the both groups. Results of the feasibility objectives included: time from admission to enrollment (mean, 47.4 hours ± 22.0 hours), time from enrollment to randomization (mean, 4.8 hours ± 9.1 hours), time from randomization to IVCF placement (mean, 16.9 hours ± 9.2 hours), adherence to weekly compression ultrasound within first month (IVCF group = 44.4%; non-IVCF group = 62.5%), and 1-month clinical follow-up (IVCF group = 83.3%; non-IVCF group = 100%). At 6-month follow-up, one PE in the nonfilter group and one DVT in the filter group had occurred. One non-PE-related death occurred in the filter group. Barriers to enrollment included inability to obtain informed consent due to patient refusal or no next of kin identified and delayed notification of eligibility status. Our pilot study demonstrates for the first time that a randomized controlled trial evaluating the efficacy of pIVCFs in trauma patients is feasible. This pilot data will be used to inform the design of a multicenter randomized controlled trial to determine the incidence of PE and DVT in HRTPs receiving pIVCFs versus no pIVCF.

Fish and food preservation by radiation in Bangladesh

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

Hossain, M.M.

1985-01-01

Bangladesh Atomic Energy Commission (BAEC) has been engaged for the last two decades in research and development activities in food irradiation and has been actively participating in research projects under the Regional Project in Food Irradiation (RPFI) of the RCA countries since its inception. The Institute of Food and Radiation Biology (IFRB) of the Commission has been using since 1979 a 50,000 curie Cobalt-60 gamma source (Gamma beam-650) for R and D and pilot-scale studies on food irradiation. The present status of food irradiation and its prospects of commercial introduction in Bangladesh are described.

Efficacy of a radiation absorbing shield in reducing dose to the interventionalist during peripheral endovascular procedures: a single centre pilot study.

PubMed

Power, S; Mirza, M; Thakorlal, A; Ganai, B; Gavagan, L D; Given, M F; Lee, M J

2015-06-01

This prospective pilot study was undertaken to evaluate the feasibility and effectiveness of using a radiation absorbing shield to reduce operator dose from scatter during lower limb endovascular procedures. A commercially available bismuth shield system (RADPAD) was used. Sixty consecutive patients undergoing lower limb angioplasty were included. Thirty procedures were performed without the RADPAD (control group) and thirty with the RADPAD (study group). Two separate methods were used to measure dose to a single operator. Thermoluminescent dosimeter (TLD) badges were used to measure hand, eye, and unshielded body dose. A direct dosimeter with digital readout was also used to measure eye and unshielded body dose. To allow for variation between control and study groups, dose per unit time was calculated. TLD results demonstrated a significant reduction in median body dose per unit time for the study group compared with controls (p = 0.001), corresponding to a mean dose reduction rate of 65 %. Median eye and hand dose per unit time were also reduced in the study group compared with control group, however, this was not statistically significant (p = 0.081 for eye, p = 0.628 for hand). Direct dosimeter readings also showed statistically significant reduction in median unshielded body dose rate for the study group compared with controls (p = 0.037). Eye dose rate was reduced for the study group but this was not statistically significant (p = 0.142). Initial results are encouraging. Use of the shield resulted in a statistically significant reduction in unshielded dose to the operator's body. Measured dose to the eye and hand of operator were also reduced but did not reach statistical significance in this pilot study.

Sublingual Buprenorphine/Naloxone for Chronic Pain in At-Risk Patients: Development and Pilot Test of a Clinical Protocol

PubMed Central

Rosenblum, Andrew; Cruciani, Ricardo A.; Strain, Eric C; Cleland, Charles M.; Joseph, Herman; Magura, Stephen; Marsch, Lisa A; McNicholas, Laura F; Savage, Seddon R; Sundaram, Arun; Portenoy, Russell K.

2013-01-01

Objective Sublingual buprenorphine/naloxone (Bup/Nx) is approved for addiction treatment and may be useful for pain management, particularly in opioid-treated pain patients with nonadherence behaviors. The transition of opioid-treated pain patients to buprenorphine carries the risk of precipitated withdrawal and increased pain. This study convened pain and addiction specialists to develop and pilot a clinical protocol for safe transitioning to Bup/Nx. Design The protocol was revised three times based on outside expert review and pilot study observations. The pilot was conducted with a prospective cohort of 12 patients with moderate to severe chronic pain, who were receiving long-term opioid therapy with any full μ-agonist drug, and had exhibited one or more aberrant drug-related behaviors. Patients were followed up for 3 to 6 months with the expectation that they would experience few adverse events and report lower pain severity. Results The three patients on the highest baseline opioid dose (equivalent to 303–450 mg of oral morphine) and the three on the lowest doses (≤20 mg) had early adverse events (AEs) when switched to Bup/Nx and did not complete the trial. Of the remaining six, one withdrew due to AEs; one responded well, then withdrew; and four completed a three-month trial. A mixed effects model controlling for dropouts found that average and worst pain significantly decreased after the switch to Bup/Nx (both p < .01). Conclusion Based on this experience, the protocol recommends Bup/Nx for pain only when baseline opioid doses are within bounds that reduce AEs at transition and incorporates dose flexibility to further reduce risks. This protocol warrants further testing. PMID:23264315

Proposed primary endpoints for use in clinical trials that compare treatment options for bloodstream infection in adults: a consensus definition.

PubMed

Harris, P N A; McNamara, J F; Lye, D C; Davis, J S; Bernard, L; Cheng, A C; Doi, Y; Fowler, V G; Kaye, K S; Leibovici, L; Lipman, J; Llewelyn, M J; Munoz-Price, S; Paul, M; Peleg, A Y; Rodríguez-Baño, J; Rogers, B A; Seifert, H; Thamlikitkul, V; Thwaites, G; Tong, S Y C; Turnidge, J; Utili, R; Webb, S A R; Paterson, D L

2017-08-01

To define standardized endpoints to aid the design of trials that compare antibiotic therapies for bloodstream infections (BSI). Prospective studies, randomized trials or registered protocols comparing antibiotic therapies for BSI, published from 2005 to 2016, were reviewed. Consensus endpoints for BSI studies were defined using a modified Delphi process. Different primary and secondary endpoints were defined for pilot (small-scale studies designed to evaluate protocol design, feasibility and implementation) and definitive trials (larger-scale studies designed to test hypotheses and influence clinical practice), as well as for Staphylococcus aureus and Gram-negative BSI. For pilot studies of S. aureus BSI, a primary outcome of success at day 7 was defined by: survival, resolution of fever, stable/improved Sequential Organ Failure Assessment (SOFA) score and clearance of blood cultures, with no microbiologically confirmed failure up to 90 days. For definitive S. aureus BSI studies, a primary outcome of success at 90 days was defined by survival and no microbiologically confirmed failure. For pilot studies of Gram-negative BSI, a primary outcome of success at day 7 was defined by: survival, resolution of fever and symptoms related to BSI source, stable or improved SOFA score and negative blood cultures. For definitive Gram-negative BSI studies, a primary outcome of survival at 90 days supported by a secondary outcome of success at day 7 (as previously defined) was agreed. These endpoints provide a framework to aid future trial design. Further work will be required to validate these endpoints with respect to patient-centred clinical outcomes. Copyright © 2016 European Society of Clinical Microbiology and Infectious Diseases. All rights reserved.

Oral rehydration therapy for preoperative fluid and electrolyte management.

PubMed

Taniguchi, Hideki; Sasaki, Toshio; Fujita, Hisae

2011-01-01

Preoperative fluid and electrolyte management is usually performed by intravenous therapy. We investigated the safety and effectiveness of oral rehydration therapy (ORT) for preoperative fluid and electrolyte management of surgical patients. The study consisted of two studies, designed as a prospective observational study. In a pilot study, 20 surgical patients consumed 1000 mL of an oral rehydration solution (ORS) until 2 h before induction of general anesthesia. Parameters such as serum electrolyte concentrations, fractional excretion of sodium (FENa) as an index of renal blood flow, volume of esophageal-pharyngeal fluid and gastric fluid (EPGF), and patient satisfaction with ORT were assessed. In a follow-up study to assess the safety of ORT, 1078 surgical patients, who consumed ORS until 2 h before induction of general anesthesia, were assessed. In the pilot study, water, electrolytes, and carbohydrate were effectively and safely supplied by ORT. The FENa value was increased at 2 h following ORT. The volume of EPGF collected following the induction of anesthesia was 5.3±5.6 mL. In the follow-up study, a small amount of vomiting occurred in one patient, and no aspiration occurred in the patients. These results suggest that ORT is a safe and effective therapy for the preoperative fluid and electrolyte management of selected surgical patients.

Oral Rehydration Therapy for Preoperative Fluid and Electrolyte Management

PubMed Central

Taniguchi, Hideki; Sasaki, Toshio; Fujita, Hisae

2011-01-01

Aim: Preoperative fluid and electrolyte management is usually performed by intravenous therapy. We investigated the safety and effectiveness of oral rehydration therapy (ORT) for preoperative fluid and electrolyte management of surgical patients. Methods: The study consisted of two studies, designed as a prospective observational study. In a pilot study, 20 surgical patients consumed 1000 mL of an oral rehydration solution (ORS) until 2 h before induction of general anesthesia. Parameters such as serum electrolyte concentrations, fractional excretion of sodium (FENa) as an index of renal blood flow, volume of esophageal-pharyngeal fluid and gastric fluid (EPGF), and patient satisfaction with ORT were assessed. In a follow-up study to assess the safety of ORT, 1078 surgical patients, who consumed ORS until 2 h before induction of general anesthesia, were assessed. Results: In the pilot study, water, electrolytes, and carbohydrate were effectively and safely supplied by ORT. The FENa value was increased at 2 h following ORT. The volume of EPGF collected following the induction of anesthesia was 5.3±5.6 mL. In the follow-up study, a small amount of vomiting occurred in one patient, and no aspiration occurred in the patients. Conclusion: These results suggest that ORT is a safe and effective therapy for the preoperative fluid and electrolyte management of selected surgical patients. PMID:21897763

Use of the SONET score to evaluate Urgent Care Center overcrowding: a prospective pilot study.

PubMed

Wang, Hao; Robinson, Richard D; Cowden, Chad D; Gorman, Violet A; Cook, Christopher D; Gicheru, Eugene K; Schrader, Chet D; Jayswal, Rani D; Zenarosa, Nestor R

2015-04-14

To derive a tool to determine Urgent Care Center (UCC) crowding and investigate the association between different levels of UCC overcrowding and negative patient care outcomes. Prospective pilot study. Single centre study in the USA. 3565 patients who registered at UCC during the 21-day study period were included. Patients who had no overcrowding statuses estimated due to incomplete collection of operational variables at the time of registration were excluded in this study. 3139 patients were enrolled in the final data analysis. A crowding estimation tool (SONET: Severely overcrowded, Overcrowded and Not overcrowded Estimation Tool) was derived using the linear regression analysis. The average length of stay (LOS) in UCC patients and the number of left without being seen (LWBS) patients were calculated and compared under the three different levels of UCC crowding. Four independent operational variables could affect the UCC overcrowding score including the total number of patients, the number of results pending for patients, the number of patients in the waiting room and the longest time a patient was stationed in the waiting room. In addition, UCC overcrowding was associated with longer average LOS (not overcrowded: 133±76 min, overcrowded: 169±79 min, and severely overcrowded: 196±87 min, p<0.001) and an increased number of LWBS patients (not overcrowded: 0.28±0.69 patients, overcrowded: 0.64±0.98, and severely overcrowded: 1.00±0.97). The overcrowding estimation tool (SONET) derived in this study might be used to determine different levels of crowding in a high volume UCC setting. It also showed that UCC overcrowding might be associated with negative patient care outcomes. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

Prospective patients rate practice factors: development of a questionnaire.

PubMed

St Louis, Brian Lingg; Firestone, Allen R; Johnston, William; Shanker, Shiva; Vig, Katherine W L

2011-02-01

The importance that prospective patients place on practice characteristics when choosing an orthodontic practice has not been extensively reported. The objective of this research was to develop a valid and reliable questionnaire to address the relative importance of orthodontic office and doctor characteristics for prospective patients or parents of child patients during the initial orthodontic office consultation. An initial questionnaire, based on published literature, was field-tested on 16 subjects to assess its validity. Based on the field test, the questionnaire was modified and tested for reliability by using a test-retest method. The questionnaire covered the following areas: doctor, office, staff, and finances. The reliability study included 2 groups of subjects: 12 consecutive prospective adult patients and 41 consecutive parents of prospective child patients. The questionnaires consisted of 43 and 50 questions for the adult patients and the parents of patients, respectively. The subjects rated the importance of practice characteristics in their selection of an orthodontic practice using a 100-mm visual analog scale anchored at "not important at all" and "most important." Reliability was analyzed by using the intraclass correlation coefficient (ICC). Summary scores of all 53 subjects showed excellent reliability (ICC, 0.88; range, 0.61-1.0). Summary scores of all 50 questions showed acceptable reliability (ICC, 0.70; range, 0.45-0.88). Twenty-one questions had excellent reliability (ICC, >.75), and 29 questions had fair-to-good reliability (ICC, 0.41-0.75). No questions showed poor reliability (ICC, <0.4). The pilot study data indicated that the overall reliability of the questionnaire is acceptable. Copyright © 2011 American Association of Orthodontists. Published by Mosby, Inc. All rights reserved.

Factors Associated With Burnout Among US Hospital Clinical Pharmacy Practitioners: Results of a Nationwide Pilot Survey.

PubMed

Jones, G Morgan; Roe, Neil A; Louden, Les; Tubbs, Crystal R

2017-12-01

Background: In health care, burnout has been defined as a psychological process whereby human service professionals attempting to positively impact the lives of others become overwhelmed and frustrated by unforeseen job stressors. Burnout among various physician groups who primarily practice in the hospital setting has been extensively studied; however, no evidence exists regarding burnout among hospital clinical pharmacists. Objective: The aim of this study was to characterize the level of and identify factors independently associated with burnout among clinical pharmacists practicing in an inpatient hospital setting within the United States. Methods: We conducted a prospective, cross-sectional pilot study utilizing an online, Qualtrics survey. Univariate analysis related to burnout was conducted, with multivariable logistic regression analysis used to identify factors independently associated with the burnout. Results: A total of 974 responses were analyzed (11.4% response rate). The majority were females who had practiced pharmacy for a median of 8 years. The burnout rate was high (61.2%) and largely driven by high emotional exhaustion. On multivariable analysis, we identified several subjective factors as being predictors of burnout, including inadequate administrative and teaching time, uncertainty of health care reform, too many nonclinical duties, difficult pharmacist colleagues, and feeling that contributions are underappreciated. Conclusions: The burnout rate of hospital clinical pharmacy providers was very high in this pilot survey. However, the overall response rate was low at 11.4%. The negative effects of burnout require further study and intervention to determine the influence of burnout on the lives of clinical pharmacists and on other health care-related outcomes.

Investigating the Feasibility and Utility of Bedside Balance Technology Acutely After Pediatric Concussion: A Pilot Study.

PubMed

Rhine, Tara D; Byczkowski, Terri L; Clark, Ross A; Babcock, Lynn

2016-05-01

To examine postural instability in children acutely after concussion, using the Wii Balance Board (WBB). We hypothesized that children with traumatic brain injury would have significantly worse balance relative to children without brain injury. Prospective case-control pilot study. Emergency department of a tertiary urban pediatric hospital. Cases were a convenience sample 11-16 years old who presented within 6 hours of sustaining concussion. Two controls, matched on gender, height, and age, were enrolled for each case that completed study procedures. Controls were children who presented for a minor complaint that was unlikely to affect balance. Not applicable. The participant's postural sway expressed as the displacement in centimeters of the center of pressure during a timed balance task. Balance testing was performed using 4 stances (single or double limb, eyes open or closed). Three of the 17 (17.6%) cases were too dizzy to complete testing. One stance, double limbs eyes open, was significantly higher in cases versus controls (85.6 vs 64.3 cm, P = 0.04). A simple test on the WBB consisting of a 2-legged standing balance task with eyes open discriminated children with concussion from non-head-injured controls. The low cost and feasibility of this device make it a potentially viable tool for assessing postural stability in children with concussion for both longitudinal research studies and clinical care. These pilot data suggest that the WBB is an inexpensive tool that can be used on the sideline or in the outpatient setting to objectively identify and quantify postural instability.

Active video gaming in patients with renal transplant: a pilot study

PubMed Central

2014-01-01

Background Patients with renal transplant are at higher risk of mortality from cardiovascular disease (CVD) compared with the general population. Physical activity has been shown to reduce the risk of CVD mortality in these patients. Unfortunately, barriers such as the harsh Canadian climate prevent patients from engaging in and harvesting the health benefits of physical activity. This pilot study explored active video gaming (AVG) as a way for patients with renal transplant to obtain physical activity and examined its effect on their functional status and quality of life (QOL). Main text We recruited nine patients for an 8-week prospective pilot study. All patients received a Microsoft Xbox 360™ video gaming console, a Microsoft Kinect™ sensor, and the video game Your Shape Fitness Evolved 2012. Assessment of each participant before and after the intervention included blood pressure measures, a 6-minute walk test, and the Godin Leisure Time Questionnaire (GLTQ). We analyzed all nine patients at the end of the 8-week study period, and found no changes in blood pressure or GLTQ scores. However, there was a significant increase in the 6-minute walk distance (P = 0.022), which represented a consistent increase for most patients (correlation = 0.977). In addition, participants over the age of 45 years (n = 4) were more likely to use the AVG system (P = 0.042). Conclusion AVG has the potential to improve the functional status in patients with renal transplant. Further research is required to corroborate the full health benefits of AVG in this patient population. PMID:25114788

A pilot study using children's books to understand caregiver perceptions of parenting practices.

PubMed

Bauer, Nerissa S; Hus, Anna M; Sullivan, Paula D; Szczepaniak, Dorota; Carroll, Aaron E; Downs, Stephen M

2012-06-01

To conduct a pilot study to test the feasibility and acceptability of using children's books to understand caregiver perceptions of parenting practices around common behavior challenges. A prospective 1-month pilot study was conducted in 3 community-based pediatric clinics serving lower income families living in central Indianapolis. One hundred caregivers of 4- to 7-year-old children presenting for a well-child visit chose 1 of 3 available children's books that dealt with a behavioral concern the caregiver reported having with the child. The book was read aloud to the child in the caregiver's presence by a trained research assistant and given to the families to take home. Outcomes measured were caregiver intent to change their interaction with their child after the book reading, as well as caregiver reports of changes in caregiver-child interactions at 1 month. Reading the book took an average of 3 minutes. Most (71%) caregivers reported intent to change after the book reading; two-thirds (47/71) were able to identify a specific technique or example illustrated in the story. One month later, all caregivers remembered receiving the book, and 91% reported reading the book to their child and/or sharing it with someone else. Three-fourths of caregivers (60/80) reported a change in caregiver-child interactions. The distribution of children's books with positive parenting content is a feasible and promising tool, and further study is warranted to see whether these books can serve as an effective brief intervention in pediatric primary care practice.

Intermittent granulocyte and monocyte apheresis versus mercaptopurine for maintaining remission of ulcerative colitis: a pilot study.

PubMed

Sakuraba, Atsushi; Sato, Toshiro; Morohoshi, Yuichi; Matsuoka, Katsuyoshi; Okamoto, Susumu; Inoue, Nagamu; Takaishi, Hiromasa; Ogata, Haruhiko; Iwao, Yasushi; Hibi, Toshifumi

2012-06-01

The effect of granulocyte and monocyte adsorption apheresis (GMA) on prevention of relapse of ulcerative colitis (UC) is not clear. This was a pilot open-labeled, prospective, randomized, unblinded study to compare the tolerability and efficacy of intermittent GMA (once every 2 weeks) with mercaptopurine to maintain remission of UC. Twenty-one patients with UC, who had achieved remission by induction therapies were randomly assigned to receive either intermittent GMA (N = 10) or oral mercaptopurine (0.5 mg/kg per day; N = 11). The study period was 24 months. The rate of the patients maintaining remission and the incidences of adverse effects were compared between the two groups. At 24 months, seven of 10 patients (70.0%) on intermittent GMA and seven of 11 patients (63.6%, P = 1.00) on oral mercaptopurine were still in remission. Three patients relapsed in each group. One patient taking mercaptopurine, but none receiving intermittent GMA, dropped out because of adverse effects. Intermittent therapy with GMA was well tolerated and a substantial proportion of patients maintained remission. Intermittent GMA therapy in maintaining remission of UC merits further investigation. © 2012 The Authors. Therapeutic Apheresis and Dialysis © 2012 International Society for Apheresis.

Electrolytic ablation as an adjunct to liver resection: Safety and efficacy in patients.

PubMed

Wemyss-Holden, Simon A; Berry, David P; Robertson, Gavin S M; Dennison, Ashley R; De La M Hall, Pauline; Maddern, Guy J

2002-08-01

Electrolytic ablation is a relatively new method for the local destruction of colorectal liver metastases. Experimental work in animal models has shown this method to be safe and efficacious. However, before proceeding to clinical trials it was necessary to confirm these findings in a pilot study of five patients. Five patients with colorectal liver metastases were studied prospectively. Each patient underwent a potentially curative liver resection. One of the metastases to be removed was treated using electrolysis before resection. Each patient was monitored closely during and after electrolysis to determine any morbidity associated with the treatment. Once resected, the metastases were examined histologically for completeness of ablation. All patients tolerated the electrolysis well; there were no deaths or complications related to the treatment. Histological examination of the resected metastases which had been treated electrolytically showed complete tissue destruction with no viable malignant cells remaining at the site of treatment. This pilot study of electrolytic ablation of liver metastases in five patients showed the treatment to be well tolerated and safe. Additionally, it demonstrated total destruction of the malignant tissue at the site of electrolysis. Based on these encouraging results, clinical trials can now begin.

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

PubMed Central

2017-01-01

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

[Neuromodulation as an intervention for addiction: overview and future prospects].

PubMed

Luigjes, J; Breteler, R; Vanneste, S; de Ridder, D

2013-01-01

In recent years several neuromodulation techniques have been introduced as interventions for addiction. To review and discuss studies that have investigated the effects of treating addiction by means of electroencephalography (EEG) neurofeedback, real-time functional magnetic resonance imaging (rt-fMRI) neurofeedback, transcranial magnetic stimulation/transcranial direct current stimulation (TMS/tDCS) and deep brain stimulation (DBS). We reviewed the literature, focusing on Dutch studies in particular. Studies using EEG neurofeedback were shown to have positive effects on drug use, treatment compliance, and cue reactivity in patients with cocaine and alcohol dependence. A pilot study investigating the effects of rt-fMRI neurofeedback on nicotine dependent patients showed that modulation of the anterior cingulate cortex can decrease smokers' craving for nicotine. In several studies decreased craving was found in alcohol dependent patients after TMS or tDCS stimulation of the anterior cingulate cortex or the dorsolateral prefrontal cortex. The first DBS pilot studies suggest that the nucleus accumbens is a promising target region for the treatment of alcohol and heroin dependence. Neuromodulation provides us with a unique opportunity to directly apply neuroscientific knowledge to the treatment of addiction. However, more research is needed to ensure the efficacy, safety and feasibility of the various neuromodulation techniques that are now available.

The Systems Approach to Assessment and Evaluation of Post-Secondary Vocational Education Programs. Final Report. October 1, 1976-June 30, 1978.

ERIC Educational Resources Information Center

Hartz, John D.

A project was conducted to improve the employability and employment prospects for students by (1) identifying non-job task skills and characteristics important to job acquisition and retention, (2) constructing an instrument to assess the identified skills and characteristics, (3) pilot testing the instrument with graduates from two postsecondary…

Soluble Suppression of Tumorigenicity-2 Predicts Hospital Mortality in Burn Patients: An Observational Prospective Cohort Pilot Study.

PubMed

Ruiz-Castilla, Mireia; Bosacoma, Pau; Dos Santos, Bruce; Baena, Jacinto; Guilabert, Patricia; Marin-Corral, Judith; Masclans, Joan R; Roca, Oriol; Barret, Juan P

2018-04-10

The IL33/ST2 pathway has been implicated in the pathogenesis of different inflammatory diseases. Our aim was to analyze whether plasma levels of biomarkers involved in the IL33/ST2 axis might help to predict mortality in burn patients. Single-center prospective observational cohort pilot study performed at the Burns Unit of the Plastic and Reconstructive Surgery Department of the Vall d'Hebron University Hospital (Barcelona). All patients aged ≥18 years old with second or third-degree burns requiring admission to the Burns Unit were considered for inclusion. Blood samples were taken to measure levels of interleukins (IL)6, IL8, IL33, and soluble suppression of tumorigenicity-2 (sST2) within 24 h of admission to the Burns Unit and at day 3. Results are expressed as medians and interquartile ranges or as frequencies and percentages. Sixty-nine patients (58 [84.1%] male, mean age 52 [35-63] years, total body surface area burned 21% [13%-30%], Abbreviated Burn Severity Index 6 [4-8]) were included. Thirteen (18.8%) finally died in the Burns Unit. Plasma levels of sST2 measured at day 3 after admission demonstrated the best prediction accuracy for survival (area under the ROC curve 0.85 [0.71-0.99]; P < 0.001). The best cutoff point for the AUROC index was estimated to be 2,561. In the Cox proportional hazards model, after adjusting for potential confounding, a plasma sST2 level ≥2,561 measured at day 3 was significantly associated with mortality (HR 6.94 [1.73-27.74]; P = 0.006). Plasma sST2 at day 3 predicts hospital mortality in burn patients.

Efficacy and Safety of the Traditional Herbal Medicine, Gamiguibi-tang, in Patients With Cancer-Related Sleep Disturbance: A Prospective, Randomized, Wait-List-Controlled, Pilot Study.

PubMed

Lee, Jee Young; Oh, Hye Kyung; Ryu, Han Sung; Yoon, Sung Soo; Eo, Wankyu; Yoon, Seong Woo

2018-06-01

Sleep disturbance is the second most bothersome symptom in patients with cancer, and it can significantly impair their quality of life. The aim of this study was to investigate the efficacy and safety of the traditional herbal medicine Gamiguibi-tang (GGBT) in patients with cancer-related sleep disturbance. We conducted a prospective, randomized, wait-list-controlled, open-label pilot clinical trial on cancer-related sleep disturbance. Patients with cancer experiencing poor sleep quality with a Pittsburgh Sleep Quality Index of at least 6 were randomly assigned to the GGBT and wait-list groups to receive GGBT and conventional care, respectively, for 2 weeks. The primary endpoint was the Insomnia Severity Index (ISI) score. Fatigue, depression, and cognitive impairment were assessed as the secondary endpoints by using the Brief Fatigue Inventory (BFI), Beck Depression Inventory (BDI), and Montreal Cognitive Assessment (MoCA). Thirty participants who met the eligibility criteria were enrolled. Sleep disturbance assessed using the ISI improved significantly more in the GGBT group than in the wait-list group (-5.5 ± 4.4 vs 0.1 ± 1.1, P < .001). Fatigue level determined using the BFI also improved significantly more in the GGBT group than in the wait-list group (-0.8 ± 0.8 vs 0.0 ± 0.3, P = .002). The BDI and MoCA scores showed no significant changes. Adverse events were reported in two patients in the GGBT group and consisted of mild dyspepsia and mild edema. GGBT may be a potential treatment option for cancer-related sleep disturbance. Further research is needed to investigate the efficacy and safety of GGBT.

Intradiscal injection of fibrin sealant for the treatment of symptomatic lumbar internal disc disruption: results of a prospective multicenter pilot study with 24-month follow-up.

PubMed

Yin, Way; Pauza, Kevin; Olan, Wayne J; Doerzbacher, Jeff F; Thorne, Kevin J

2014-01-01

Assess the safety and efficacy of intradiscal fibrin sealant in adults with chronic discogenic low back pain. Prospective, nonrandomized Food and Drug Administration approved pilot study. Three centers in the United States. Fifteen adults with chronic, single, or contiguous two-level lumbar discogenic pain confirmed through meticulous provocation discography. Volume- and pressure-controlled intradiscal delivery of BIOSTAT BIOLOGX(®) Fibrin Sealant with the Biostat(®) Delivery Device into symptomatic lumbar disc(s). Assessments were performed at baseline, 72 hours, and 1, 4, 13, 26, 52, and 104 weeks following intervention. Potential adverse events were evaluated with serial assessment of neurological status, radiographic, and magnetic resonance imaging (MRI). Efficacy measures included serial assessments of low back pain visual analog scale (VAS) measurements and the Roland-Morris Disability Questionnaire (RMDQ). Safety neurological assessments, X-ray, and MRI showed no significant changes. Adverse events were reported in nine subjects. Two instances of low back muscle spasm and one case of discitis were the only events considered related to the procedure or product. Mean low back pain VAS scores (mm) decreased from 72.4 (95% confidence interval 64.6-80.3) at baseline to 31.7 (17.4-46.1), 35.4 (17.7-53.1), and 33.0 (16.3-49.6); mean RMDQ score improved from 15.2 (12.7-17.7) at baseline to 8.9 (5.3-12.5), 6.2 (3.4-9.1), and 5.6 (2.9-8.4) at 26, 52, and 104 weeks, respectively. Intradiscal injection of BIOSTAT BIOLOGX Fibrin Sealant with the Biostat Delivery Device appears safe and may improve pain and function in selected patients with discogenic pain. Wiley Periodicals, Inc.

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

PubMed

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

2017-01-01

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

Insidious Harm of Medication Diluents as a Contributor to Cumulative Volume and Hyperchloremia: A Prospective, Open-Label, Sequential Period Pilot Study.

PubMed

Magee, Carolyn A; Bastin, Melissa L Thompson; Laine, Melanie E; Bissell, Brittany D; Howington, Gavin T; Moran, Peter R; McCleary, Emily J; Owen, Gary D; Kane, Lauren E; Higdon, Emily A; Pierce, Cathy A; Morris, Peter E; Flannery, Alexander H

2018-05-04

Although the potential dangers of hyperchloremia from resuscitation fluids continue to emerge, no study to date has considered the contribution of medication diluents to cumulative volume and hyperchloremia. This study compares saline versus dextrose 5% in water as the primary medication diluent and the occurrence of hyperchloremia in critically ill patients. Prospective, open-label, sequential period pilot study. Medical ICU of a large academic medical center. Adult patients admitted to the medical ICU were eligible for inclusion. Patients who were admitted for less than 48 hours, less than 18 years old, pregnant, incarcerated, or who had brain injury were excluded. Saline as the primary medication diluent for 2 months followed by dextrose 5% in water as the primary medication diluent for 2 months. A total of 426 patients were included, 216 in the saline group and 210 in the dextrose 5% in water group. Medication diluents accounted for 63% of the total IV volume over the observation period. In the saline group, 17.9% developed hyperchloremia compared with 10.5% in the dextrose 5% in water group (p = 0.037), which was statistically significant in multivariable analysis (odds ratio, 0.50; 95% CI, 0.26-0.94; p = 0.031). In the saline group, 34.2% developed acute kidney injury versus 24.5% in the dextrose 5% in water group (p = 0.035); however, this was not statistically significant when adjusting for baseline covariates. No other significant differences in dysnatremias, insulin requirements, glucose control, ICU length of stay, or ICU mortality were observed. This study identified that medication diluents contribute substantially to the total IV volume received by critically ill patients. Saline as the primary medication diluent compared with dextrose 5% in water is associated with hyperchloremia, a possible risk factor for acute kidney injury.

Three-month treatment with triptorelin, letrozole and ulipristal acetate before hysteroscopic resection of uterine myomas: prospective comparative pilot study.

PubMed

Bizzarri, Nicolò; Ghirardi, Valentina; Remorgida, Valentino; Venturini, Pier Luigi; Ferrero, Simone

2015-09-01

To compare the usefulness of preoperative treatment with triptorelin, letrozole or ulipristal acetate or no treatment before hysteroscopic removal of uterine submucosal myomas. Single center prospective non-randomized comparative pilot study. The study included consecutive premenopausal patients undergoing hysteroscopic resection of myomas graded as type 0, type 1 or type 2 according to the FIGO classification with diameter between 20 and 35 mm. Exclusion criteria were: associated polyps, associated non-hysteroscopic surgical procedures, >2 myomas requiring hysteroscopic resection. This study enrolled patients who underwent either direct surgery (group S; n=23) or 3-month preoperative treatment with triptorelin (3.75 mg every 28 days; group T; n=20), letrozole (2.5 mg/day; group L; n=11) or ulipristal acetate (5 mg/day; group U; n=7). Patients underwent hysteroscopic resection of the myomas. All medical treatments caused a significant decrease in the volume of myomas (group T, p<.001; group L, p<.001; group U, p=.006); however, the percentage decrease in myoma volume was lower in group U than in group T (p=.001) and in group L (p=.010). The hysteroscopy time was higher in group S than in group T (p<.001) and in group L (p=.001); there was no significant difference in the hysteroscopy time between group S and group U (p=.206). Fluid absorption was lower in group T than in group S (p=.002) and in group L than in group S (p=.048); fluid absorption was similar in group S and group U (p=.110). Intra- and postoperative complications, postoperative pain, and patient satisfaction were similar in the four study groups. Surgeon's evaluation of operative difficulty was better in group T than in group S (p<.005). Preoperative treatment with triptorelin and letrozole decreases the hysteroscopy time and the volume of fluid absorbed during hysteroscopic resection of uterine submucosal myomas. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.

Early skin-to-skin contact after cesarean section: A randomized clinical pilot study

PubMed Central

Kollmann, Martina; Aldrian, Lisa; Scheuchenegger, Anna; Mautner, Eva; Herzog, Sereina A.; Urlesberger, Berndt; Raggam, Reinhard B.; Lang, Uwe; Obermayer-Pietsch, Barbara; Klaritsch, Philipp

2017-01-01

Objective Early bonding by skin-to-skin contact (SSC) has been demonstrated to be beneficial for mothers and newborns following vaginal delivery. The aim of this study was to investigate the impact of intraoperative bonding (early SSC) after cesarean section on neonatal adaptation, maternal pain and stress response. Study design This prospective, randomized-controlled pilot study was performed at a single academic tertiary hospital (Department of Obstetrics and Gynecology, Medical University of Graz, Austria) between September 2013 and January 2014. Women were randomly assigned to intraoperative (“early”) SCC (n = 17) versus postoperative (“late”) SCC (n = 18). Main variables investigated were neonatal transition (Apgar score, arterial oxygen saturation, heart rate and temperature), maternal pain perception and both maternal and neonatal stress response by measuring the stress biomarkers salivary free cortisol and salivary alpha amylase. Results There was no evidence for differences in parameters reflecting neonatal transition or stress response between the ‘Early SSC Group’ and the ‘Late SSC Group’. Maternal salivary cortisol and alpha-amylase levels as well as maternal wellbeing and pain did not differ between the groups. However, the rise of maternal salivary alpha-amylase directly after delivery was higher in the ‘Early SSC Group’ compared to the ‘Late SSC Group’ (p = 0.004). Conclusions This study did not reveal significant risks for the newborn in terms of neonatal transition when early SSC is applied in the operating room. Maternal condition and stress marker levels did not differ either, although the rise of maternal salivary alpha-amylase directly after delivery was higher in the ‘Early SSC Group’ compared to the ‘Late SSC Group’, which may indicate a stressor sign due to intensive activation of the sympathetic-adreno-medullary-system. This needs to be further evaluated in a larger prospective randomized trial. Trial registration ClinicalTrials.gov NCT01894880 PMID:28231274

Immunogenicity and Safety of the 13-Valent Pneumococcal Conjugate Vaccine versus the 23-Valent Polysaccharide Vaccine in Unvaccinated HIV-Infected Adults: A Pilot, Prospective Controlled Study.

PubMed

Lombardi, Francesca; Belmonti, Simone; Fabbiani, Massimiliano; Morandi, Matteo; Rossetti, Barbara; Tordini, Giacinta; Cauda, Roberto; De Luca, Andrea; Di Giambenedetto, Simona; Montagnani, Francesca

2016-01-01

Definition of the optimal pneumococcal vaccine strategy in HIV-infected adults is still under evaluation. We aimed to compare immunogenicity and safety of the 13-valent pneumococcal conjugate vaccine (PCV13) versus the 23-valent polysaccharide vaccine (PPSV23) in HIV-infected adults. We performed a pilot, prospective controlled study enrolling HIV-infected pneumococcal vaccine-naïve outpatients, aged 18-65 years with CD4 counts ≥200 cells/μL. Eligible subjects were recruited into two parallel groups: group 1 (n = 50) received two doses of PCV13 eight weeks apart, and group 2 (n = 50) received one dose of PPSV23, as part of their standard of care. Anti-pneumococcal capsular polysaccharide immunoglobulin G concentrations were quantified by ELISA at baseline, 8, 24 and 48 weeks. Clinical and viro-immunological follow-up was performed at the same time points. Unvaccinated, age-matched HIV-negative adults (n = 100) were also enrolled as baseline controls. Pre-vaccination specific IgG titers for each pneumococcal antigen did not differ between study groups but they were constantly lower than those from the HIV-negative controls. After immunization, significant increases in IgG titers were observed in both study groups at each time point compared to baseline, but response to serotype 3 was blunted in group 1. Antibody titers for each antigen did not differ between study groups at week 48. Overall, the proportion of subjects achieving seroprotection and seroconversion to all serotypes was comparable between groups. A marked decrease in IgG levels over time was observed with both vaccines. No relevant adverse reactions were reported in either group. In this population with favorable immune profile, no relevant differences were observed in immunogenicity between PCV13 and PPSV23. Both vaccines were safe and well tolerated. ClinicalTrials.gov NCT02123433.

Sleep Quantity and Quality during Acute Concussion: A Pilot Study

PubMed Central

Raikes, Adam C.; Schaefer, Sydney Y.

2016-01-01

Study Objectives: A number of subjective and objective studies provide compelling evidence of chronic post-concussion changes in sleep, yet very little is known about the acute effects of concussion on sleep quality and quantity. Therefore, the purpose of this prospective pilot study was to use actigraphy to examine the changes in sleep quality and quantity acutely following concussion at home rather than in a hospital or sleep laboratory. Methods: Seventeen young adults (7 with acute concussion, 10 controls) were recruited for this study. All participants completed two 5-day testing sessions separated by 30 days from intake (controls) or day of injury (concussion). Participants wore actigraphs and kept a sleep journal. Sleep parameter outcomes included nighttime total sleep time (nTST), 24-h total sleep time (TST), wake after sleep onset (WASO), and sleep efficiency (SE). The coefficient of variation (CV) for each sleep parameter was computed for each session. Results: nTST and TST CV was significantly greater in the concussion group. There is the additional indication that individuals with a concussion may require and obtain more sleep shortly after injury and subsequently have a shorter duration of sleep at 1 mo post-injury. This pattern was not seen in the measures of sleep quality (WASO, SE). Conclusions: Individuals with a concussion demonstrated increased nighttime sleep duration variability. This increase persisted at 1 mo post-injury and may be associated with previously documented self-reports of poor sleep quality lasting months and years after a concussion. Additionally, this increase may predispose individuals to numerous negative health outcomes if left untreated. Citation: Raikes AC, Schaefer SY. Sleep quantity and quality during acute concussion: a pilot study. SLEEP 2016;39(12):2141–2147. PMID:27748242

The use of smartphones to influence lifestyle changes in overweight and obese youth with congenital heart disease: a single-arm study: Pilot and feasibility study protocol: Smart Heart Trial.

PubMed

Rombeek, Meghan; De Jesus, Stefanie; Altamirano-Diaz, Luis; Welisch, Eva; Prapavessis, Harry; Seabrook, Jamie A; Norozi, Kambiz

2017-01-01

Both obesity and congenital heart disease (CHD) are risk factors for the long-term cardiovascular health of children and adolescents. The addition of smart mobile technology to conventional lifestyle counseling for weight management offers great potential to appeal to technologically literate youth and can address a large geographical area with minimal burden to participants. This pilot study seeks to examine the influence of a 1-year lifestyle intervention on nutrition and physical activity-related health outcomes in overweight or obese children and adolescents with CHD. This is a pilot and feasibility study which utilizes a single-arm, prospective design with a goal to recruit 40 overweight and obese patients. The feasibility metrics will evaluate the integrity of the study protocol, data collection and questionnaires, recruitment and consent, and acceptability of the intervention protocol and primary outcome measures. The primary clinical outcome metrics are anthropometry, body composition, and cardiorespiratory exercise capacity. The secondary clinical metrics include quality of life, nutrition and physical activity behavior, lung and muscle function, and cardio-metabolic risk factors. Outcomes are assessed at baseline, 6 months, and 1 year. To date, a total of 36 children and youth (11 girls), aged 7-17 years (mean = 14.4 years), have commenced the intervention. Recruitment for the study was initiated in June 2012 and is currently ongoing. The information provided in this paper is intended to help researchers and health professionals with the development and evaluation of similar lifestyle intervention programs. Since the application of smartphones to pediatric cardiac health and obesity management is a novel approach, and continued research in this area is warranted, this paper may serve as a foundation for further exploration of this health frontier and inform the development of a broader strategy for obesity management in pediatric cardiology. This pilot study was retrospectively registered at the www.ClinicalTrials.gov registry as NCT02980393 in November 2016, with the study commencing in May 2012. Study protocol version 15OCT2014.

Post-acute crisis text messaging outreach for suicide prevention: a pilot study.

PubMed

Berrouiguet, Sofian; Gravey, Michel; Le Galudec, Mickaël; Alavi, Zarrin; Walter, Michel

2014-07-30

Several post-suicide prevention strategies such as sending postcards or making phone calls have been used to keep in contact with suicide attempters. The continuity of care has been beneficial to the prevention of post-acute suicidal behaviors. The aim of the study was to evaluate the technical feasibility and acceptability of text messaging outreach in post-acute suicide attempters. Eighteen post-suicidal patients were included in a prospective, monocentric, open-label, 2 months pilot study. The text messages were sent from the intranet program that we specially developed for the study. Technical feasibility of this text message intervention was evaluated by the analysis of text message reports. Acceptability of such intervention was evaluated by a standardized phone interview. Our study showed that receiving text messages sent from an intranet program after a suicide attempt is technically possible. This post-crisis outreach program was accepted by the patients who found it to have a positive preventive impact. Text messaging outreach offers several advantages such as lower cost, and easier utilization compared to current post-acute care strategies. We suggest further randomized controlled trials in a large sample of suicidal patients to assess the efficacy of this novel outreach tool for prevention of post-acute suicide. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.

Impact of Ultrasound on Short Peripheral Intravenous Catheter Placement on Vein Thrombosis Risk.

PubMed

Holder, Max R; Stutzman, Sonja E; Olson, DaiWai M

Approximately 90% of hospitalized patients have a short peripheral intravenous catheter (SPC) placed. Methods of inserting the catheter have evolved over time and now include the use of ultrasound (US)-guided procedures for placement. Little is known about the impact that US-guided procedures have on the vein. This study compared the rate of venous thrombosis in patients with and without US-guided catheter placement. This prospective, single-blind, observational study assessed for venous thrombosis in 153 veins from 135 patients. Veins were evaluated by a research nurse blinded to the method of placement between 48 and 72 hours after the SPC was placed. The Fisher exact test showed a significant difference between vessel compressibility and catheter insertion method (P = .0012). The proportion of noncompressible veins was significantly greater when US was used in comparison with freehand SPC insertion. The Mantel-Haenszel chi-square value of 10.34 (P = .0013) showed that US insertion technique is associated with a higher likelihood of noncompressible veins. This pilot study provides compelling evidence that the use of US to assist with catheter placement is associated with a higher rate of noncompressible veins at day 2 or 3. Further studies are needed with a larger sample to determine the generalizability of the results from this pilot study.

Visual and flight performance recovery after PRK or LASIK in helicopter pilots.

PubMed

Van de Pol, Corina; Greig, Joanna L; Estrada, Art; Bissette, Gina M; Bower, Kraig S

2007-06-01

Refractive surgery, specifically photorefractive keratectomy (PRK) and laser in situ keratomileusis (LASIK), is becoming more accepted in the military environment. Determination of the impact on visual performance in the more demanding aviation environment was the impetus for this study. A prospective evaluation of 20 Black Hawk pilots pre-surgically and at 1 wk, 1 mo, and 6 mo postsurgery was conducted to assess both PRK and LASIK visual and flight performance outcomes on the return of aviators to duty. Of 20 pilots, 19 returned to flight status at 1 mo after surgery; 1 PRK subject was delayed due to corneal haze and subjective visual symptoms. Improvements were seen under simulator night and night vision goggle flight after LASIK; no significant changes in flight performance were measured in the aircraft. Results indicated a significantly faster recovery of all visual performance outcomes 1 wk after LASIK vs. PRK, with no difference between procedures at 1 and 6 mo. Low contrast acuity and contrast sensitivity only weakly correlated to flight performance in the early post-operative period. Overall flight performance assessed in this study after PRK and LASIK was stable or improved from baseline, indicating a resilience of performance despite measured decrements in visual performance, especially in PRK. More visually demanding flight tasks may be impacted by subtle changes in visual performance. Contrast tests are more sensitive to the effects of refractive surgical intervention and may prove to be a better indicator of visual recovery for return to flight status.

Validation of serum progesterone <35nmol/L as a predictor of miscarriage among women with threatened miscarriage.

PubMed

Lek, Sze Min; Ku, Chee Wai; Allen, John C; Malhotra, Rahul; Tan, Nguan Soon; Østbye, Truls; Tan, Thiam Chye

2017-03-06

Our recent paper, based on a pilot cohort of 119 women, showed that serum progesterone <35 nmol/L was prognostic of spontaneous miscarriage by 16 weeks in women with threatened miscarriage in early pregnancy. Using a larger cohort of women from the same setting (validation cohort), we aim to assess the validity of serum progesterone <35 nmol/L with the outcome of spontaneous miscarriage by 16 weeks. In a prospective cohort study, 360 pregnant women presenting with threatened miscarriage between gestation weeks 6-10 at a tertiary hospital emergency unit for women in Singapore were recruited for this study. The main outcome measure measured is spontaneous miscarriage prior to week 16 of gestation. Area under the ROC curve (AUC) and test characteristics (sensitivity, specificity, positive and negative predictive value) at a serum progesterone cutpoint of <35 nmol/L for predicting high and low risk of spontaneous miscarriage by 16 weeks were compared between the Pilot and Validation cohorts. Test characteristics and AUC values using serum progesterone <35 nmol/L in the validation cohort were not significantly different from those in the Pilot cohort, demonstrating excellent accuracy and reproducibility of the proposed serum progesterone cut-off level. The cut-off value for serum progesterone (35 nmol/L) demonstrated clinical relevance and allow clinicians to stratify patients into high and low risk groups for spontaneous miscarriage.

Analysis of four recruitment methods for obtaining normative data through a Web-based questionnaire: a pilot study.

PubMed

Nolte, Michael T; Shauver, Melissa J; Chung, Kevin C

2015-09-01

Quality normative data requires a diverse sample of participants and plays an important role in the appropriate use of health outcomes. Using social media and other online resources for survey recruitment is a tempting prospect, but the effectiveness of these methods in collecting a diverse sample is unknown. The purpose of this study is to pilot test four methods of recruitment to determine their ability to produce a sample representative of the general US population. This project is part of a larger study to gather normative data for the Michigan Hand Outcomes Questionnaire (MHQ). We used flyers, e-mail, Facebook, and an institution-specific clinical research recruitment Web site to direct participants to complete an online version of the MHQ. Participants also provided comorbidity and demographic information. The institution-specific recruitment Web site yielded the greatest number of respondents in an age distribution that mirrored the US population. Facebook was effective for recruiting young adults, and e-mail was successful for recruiting the older adults. None of the methods was successful in reaching an ethnically diverse sample. Obtaining normative data that is truly representative of the US population is a difficult task. The use of any one recruitment method is unlikely to result in a representative sample, but a greater understanding of these methods will empower researchers to use them to target specific populations. This pilot analysis provides support for the use of Facebook and clinical research sites in addition to traditional methods of e-mail and paper flyers.

Free radicals and antioxidant enzymes in older adults after regular senior elastic band exercising: an experimental randomized controlled pilot study.

PubMed

Liao, Lin Yu; Chung, Wei Sheng; Chen, Kuei Min

2017-01-01

The aim of this study was to pilot test the effects of regular senior elastic band exercises on the generation of free radicals and antioxidant enzyme activities in older adults. Long-term regular exercises have positive health promotion outcomes. On the contrary, high-intensity, high-speed and short-term exercises in older adults may increase free radicals and cause chronic disease and ageing effect. A prospective randomized controlled pilot study. Data were collected during 2012. Twenty-five older adults were recruited from a community care centre, southern Taiwan and were randomly assigned to either an experimental or control group. Twenty-two participants completed the study: experimental group (n = 10) and control group (n = 12). The experimental group performed 6-month senior elastic band exercises while the control group kept regular daily routines. Both groups received blood tests (thiobarbituric acid-reacting substances and glutathione peroxidase) 30 minutes before the study began and 1 hour after the final intervention treatment. At the end of the 6-month senior elastic band exercises, no statistically significant differences in thiobarbituric acid-reacting substances and glutathione peroxidase values between the experimental and control groups. No significant differences existed in both thiobarbituric acid-reacting substances and glutathione peroxidase values before and after the 6-month senior elastic band exercises either. Regular senior elastic band exercises did not increase the generation of free radicals and antioxidant enzyme activities. Senior elastic band exercises have the potential to be promoted among older adults in the community as an exercise option without adverse effects on free radicals and have potential for mitigating ageing and increasing disease control. © 2016 John Wiley & Sons Ltd.

Beyond Borders: Understanding the Development and Mobility of Human Capital in an Age of Data-Driven Accountability. A Report on WICHE's Multistate Longitudinal Data Exchange Pilot Project

ERIC Educational Resources Information Center

Prescott, Brian T.

2014-01-01

As educational attainment grows increasingly more essential to individual and societal prosperity and simultaneously more expensive, policymakers' appetite for evidence of the return on the investment in a college education has swelled and they increasingly want to equip prospective college students and their families with concrete information…

Ultrasound-Guided 50% Ethyl Alcohol Injection for Patients With Malleolar and Olecranon Bursitis: A Prospective Pilot Study

PubMed Central

Hong, Ji Seong; Lee, Jin Hyung

2016-01-01

Objective To evaluate the feasibility and effect of ultrasound-guided ethyl alcohol injection on malleolar and olecranon synovial proliferative bursitis. Methods Twenty-four patients received ultrasound-guided 50% diluted ethyl alcohol injection at the site of synovial proliferative bursitis after aspiration of the free fluid. Results Swelling and symptoms significantly decreased in 13 of the 24 patients without any complications. Eleven patients had partial improvement in swelling and symptoms. Conclusion Ultrasound-guided alcohol injection could be an alternative therapeutic option before surgery in patients with chronic intractable malleolar and olecranon synovial proliferative bursitis. PMID:27152282

Patients' quality of life after stopping plasma exchange: a pilot study.

PubMed

Dahlan, Randah; McCormick, Brendan B; Alkhattabi, Maan; Gallo, Kerri; Clark, William F; Rock, Gail

2014-10-01

Plasma exchange is being widely used to treat various serious medical conditions. There has been very little follow-up data to describe the quality of life (QOL) of plasma exchange-recipients after active plasma exchange has stopped. To assess the QOL of plasma exchange recipients after stopping plasma exchange. A pilot study, based on responses to a postal questionnaire and clinical data obtained from the patients' charts, was carried out. The scores were computed from questionnaire responses and analyzed. The response rate was 59% with 58 patients completing a questionnaire three months after their final plasma exchange therapy. We identified significant heterogeneity in the quality of life of plasma exchange recipients after stopping plasma exchange therapy. This could be driven by different patient co-morbidities. We recommend that during follow up visits, a multi-disciplinary approach including consultation with a social worker might be considered for patients who may continue to have some limitations in their psychosocial activities post-discontinuation of plasma exchange. The high response rate to the questionnaire indicates that PLEX patients are interested in being involved in QOL studies, which suggests potential support for a prospective study of QOL with pre and post questionnaires and more detailed tracking of baseline co-morbidities. Copyright © 2014 Elsevier Ltd. All rights reserved.

A Two-Phase Pilot Study to Evaluate the Safety and Tolerability of an In Situ Polymerizing Collagen.

PubMed

Inglefield, Christopher; Rone-McCrate, Rebecca; Brooks, Robert; Zhu, Jiaxun; Grant, Sheila; DeVore, Dale P

2017-09-01

Demand for collagen-based fillers has declined primarily because of limited long-term clinical benefit and the introduction of hyaluronic acid compositions. In situ polymerizing collagen is a noncrosslinked solution of porcine collagen containing a collagenase shield that undergoes fibrillogenesis on injected into tissues forming a natural matrix. Conduct a prospective, single-center, dual-phase open-label study in 8 subjects to evaluate the safety, tolerability, and efficacy of the porcine collagen composition. In Phase I, potential hypersensitivity of the collagen composition was evaluated after skin testing in the back (men) or forearms of subjects (women). In Phase II, subjects showing no signs of hypersensitivity received collagen injections into the nasolabial area followed by evaluation at 1, 4, 8, and 12 weeks using the Global Aesthetic Improvement Scale. None of the subjects had signs of hypersensitivity and all continued in Phase II. The treating physician(s) reported no post-treatment adverse events. Improvement of the nasolabial fold was observed by the physicians and confirmed by assessment of high-resolution photographs and Global Aesthetic Improvement Scale scores over the 12-week treatment were maintained. In this pilot clinical study in situ polymerizing collagen was shown to be safe and effective throughout the 3-month study period.

Finasteride for Chronic Central Serous Chorioretinopathy

PubMed Central

Forooghian, Farzin; Meleth, Annal D.; Cukras, Catherine; Chew, Emily Y.; Wong, Wai T.; Meyerle, Catherine B.

2010-01-01

Purpose To evaluate the safety and efficacy of finasteride, an inhibitor of dihyroxytestosterone (DHT) synthesis, in the treatment of chronic central serous chorioretinopathy (CSC). Methods Five patients with chronic CSC were prospectively enrolled in this pilot study. Patients were administered finasteride (5mg) daily for 3 months, following which study medication was withheld and patients were observed for 3 months. Main outcome measures included best-corrected visual acuity (BCVA), center-subfield macular thickness and subretinal fluid volume as assessed by optical coherence tomography (OCT). Serum DHT, serum testosterone, and urinary cortisol were also measured. Results There was no change in mean BCVA. Mean center-subfield macular thickness and subretinal fluid volume reached a nadir at 3 months, and rose to levels that were below baseline by 6 months. The changes in both OCT parameters paralleled changes in serum DHT level. In four patients, center-subfield macular thickness and/or subretinal fluid volume increased following discontinuation of finasteride. In the remaining patient, both OCT parameters normalized with finasteride and remained stable when the study medication was discontinued. Conclusion Finasteride may represent a novel medical treatment for chronic CSC. Larger controlled clinical trials are needed to further assess the efficacy of finasteride for the treatment of CSC. Summary Pilot study to evaluate finasteride for treatment of chronic central serous chorioretinopathy suggests efficacy and tolerability. PMID:21273946

A Pilot Study of Microbial Contamination of Subtropical Recreational Waters

PubMed Central

Fleming, Lora E; Solo, Gabriele H.; Elmir, Samir; Shibata, Tomoyuki; Squicciarini, Dominick; Quirino, Wendy; Arguello, Margia; Van de Bogart, Gayl

2009-01-01

Microbial water quality indicators are used to determine whether a water body is safe for recreational purposes. There have been concerns raised about the appropriate use of microbial indicators to regulate recreational uses of water bodies, in particular those located in tropical and sub-tropical environments. This prospective cohort pilot study evaluated the relationship between microbial water quality indicators and public health within two public beaches without known sewage discharge, but with historically high microbial levels for one beach, in subtropical Miami-Dade County (Florida). Monitoring was conducted in three phases: daily water monitoring, beach sand sampling, and spatially intense water sampling. An epidemiological questionnaire from a Los Angeles recreational beach-goer study was used to assess the self-reported swimming-related symptoms and exposures. There was no significant association between the number nor the type of reported symptoms and the different sampling months or beach sites, although persons who returned repeatedly to the beach were more likely to report symptoms. The number of indicator organisms correlated negatively with the frequency of symptoms reported by recreational beach goers. Results of the daily monitoring indicated that different indicators provided conflicting results concerning beach water quality. Larger epidemiologic studies with individual exposure monitoring are recommended to further evaluate these potentially important associations in subtropical recreational waters. PMID:20151031

A Prospective Multicenter Study Evaluating Secondary Adrenal Suppression After Antiemetic Dexamethasone Therapy in Cancer Patients Receiving Chemotherapy: A Korean South West Oncology Group Study.

PubMed

Han, Hye Sook; Park, Ji Chan; Park, Suk Young; Lee, Kyu Taek; Bae, Sang Byung; Kim, Han Jo; Kim, Samyoung; Yun, Hwan Jung; Bae, Woo Kyun; Shim, Hyun-Jeong; Hwang, Jun-Eul; Cho, Sang-Hee; Park, Moo-Rim; Shim, Hyeok; Kwon, Jihyun; Choi, Moon Ki; Kim, Seung Taik; Lee, Ki Hyeong

2015-12-01

In a previous pilot study, adrenal suppression was found to be common after antiemetic dexamethasone therapy in cancer patients. The objective of this large prospective multicenter study was to confirm the incidence and factors associated with secondary adrenal suppression related to antiemetic dexamethasone therapy in cancer patients receiving chemotherapy. Chemotherapy-naïve patients who were scheduled to receive at least three cycles of highly or moderately emetogenic chemotherapy with dexamethasone as an antiemetic were enrolled. Patients with a suppressed adrenal response before chemotherapy or those administered corticosteroids within 6 months of enrollment in the study were excluded. Between October 2010 and August 2014, 481 patients receiving chemotherapy underwent the rapid adrenocorticotropic hormone (ACTH) stimulation test to assess eligibility; 350 of these patients were included in the final analysis. Fifty-six patients (16.0%) showed a suppressed adrenal response in the rapid ACTH stimulation test at 3 or 6 months after the start of the first chemotherapy. The incidence of adrenal suppression was affected by age, performance status, stage, and use of megestrol acetate in univariate analysis. Multivariate analysis revealed that secondary adrenal suppression associated with antiemetic dexamethasone therapy was significantly associated with megestrol acetate treatment (odds ratio: 3.06; 95% confidence interval: 1.60 to 5.86; p < .001). This large prospective study indicates that approximately 15% of cancer patients receiving chemotherapy with a normal adrenal response show suppressed adrenal responses after antiemetic dexamethasone therapy. This result was particularly significant for patients cotreated with megestrol acetate. ©AlphaMed Press.

The AGE-RAGE axis in an Arab population: The United Arab Emirates Healthy Futures (UAEHFS) pilot study.

PubMed

Inman, Claire K; Aljunaibi, Abdullah; Koh, Hyunwook; Abdulle, Abdishakur; Ali, Raghib; Alnaeemi, Abdullah; Al Zaabi, Eiman; Oumeziane, Naima; Al Bastaki, Marina; Al-Houqani, Mohammed; Al-Maskari, Fatma; Al Dhaheri, Ayesha; Shah, Syed M; Abdel Wareth, Laila; Al Mahmeed, Wael; Alsafar, Habiba; Al Anouti, Fatme; Al Hosani, Ayesha; Haji, Muna; Galani, Divya; O'Connor, Matthew J; Ahn, Jiyoung; Kirchhoff, Tomas; Sherman, Scott; Hayes, Richard B; Li, Huilin; Ramasamy, Ravichandran; Schmidt, Ann Marie

2017-12-01

The transformation of the United Arab Emirates (UAE) from a semi-nomadic to a high income society has been accompanied by increasing rates of obesity and Type 2 diabetes mellitus. We examined if the AGE-RAGE (receptor for advanced glycation endproducts) axis is associated with obesity and diabetes mellitus in the pilot phase of the UAE Healthy Futures Study (UAEHFS). 517 Emirati subjects were enrolled and plasma/serum levels of AGE, carboxy methyl lysine (CML)-AGE, soluble (s)RAGE and endogenous secretory (es)RAGE were measured along with weight, height, waist and hip circumference (WC/HC), blood pressure, HbA1c, Vitamin D levels and routine chemistries. The relationship between the AGE-RAGE axis and obesity and diabetes mellitus was tested using proportional odds models and linear regression. After covariate adjustment, AGE levels were significantly associated with diabetes status. Levels of sRAGE and esRAGE were associated with BMI and levels of sRAGE were associated with WC/HC. The AGE-RAGE axis is associated with diabetes status and obesity in this Arab population. Prospective serial analysis of this axis may identify predictive biomarkers of obesity and cardiometabolic dysfunction in the UAEHFS.

Surgical intern survival skills curriculum as an intern: does it help?

PubMed

Todd, S Rob; Fahy, Bridget N; Paukert, Judy; Johnson, Melanie L; Bass, Barbara L

2011-12-01

The transition from medical student to surgical intern is fraught with anxiety. We implemented a surgical intern survival skills curriculum to alleviate this through a series of lectures and interactive sessions. The purpose of this pilot study was to evaluate its effectiveness. This was a prospective observational pilot study of our surgical intern survival skills curriculum, the components of which included professionalism, medical documentation, pharmacy highlights, radiographic interpretations, nutrition, and mock clinical pages. The participants completed pre-course and post-course surveys to assess their confidence levels in the elements addressed using a 5-point Likert scale (1 = unsatisfactory, 5 = excellent). A P value of less than .05 was considered significant. In 2009, 8 interns participated in the surgical intern survival skills curriculum. Fifty percent were female and their mean age was 27.5 ± 1.5 years. Of 33 elements assessed, interns rated themselves as more confident in 27 upon completion of the course. The implementation of a surgical intern survival skills curriculum significantly improved the confidence levels of general surgery interns and seemed to ease the transition from medical student to surgical intern. Copyright © 2011 Elsevier Inc. All rights reserved.

Mass Mapping Abell 2261 with Kinematic Weak Lensing: A Pilot Study for NASAs WFIRST mission

NASA Astrophysics Data System (ADS)

Eifler, Tim

2015-02-01

We propose to investigate a new method to extract cosmological information from weak gravitational lensing in the context of the mission design and requirements of NASAs Wide-Field Infrared Survey Telescope (WFIRST). In a recent paper (Huff, Krause, Eifler, George, Schlegel 2013) we describe a new method for reducing the shape noise in weak lensing measurements by an order of magnitude. Our method relies on spectroscopic measurements of disk galaxy rotation and makes use of the well-established Tully-Fisher (TF) relation in order to control for the intrinsic orientations of galaxy disks. Whereas shape noise is one of the major limitations for current weak lensing experiments it ceases to be an important source of statistical error in our new proposed technique. Specifically, we propose a pilot study that maps the projected mass distribution in the massive cluster Abell 2261 (z=0.225) to infer whether this promising technique faces systematics that prohibit its application to WFIRST. In addition to the cosmological weak lensing prospects, these measurements will also allow us to test kinematic lensing in the context of cluster mass reconstruction with a drastically improved signal-to-noise (S/N) per galaxy.

Effectiveness of a Pilot Partner Notification Program for New HIV Cases in Barcelona, Spain

PubMed Central

Garcia de Olalla, Patricia; Molas, Ema; Barberà, María Jesús; Martín, Silvia; Arellano, Encarnació; Gosch, Mercè; Saladie, Pilar; Carbonell, Teresa; Knobel, Hernando; Diez, Elia; Caylà, Joan A

2015-01-01

Background An estimated 30% of HIV cases in the European Union are not aware of their serological status. This study aimed to assess the effectiveness of a pilot HIV partner notification program. Methods HIV cases diagnosed between January 2012 and June 2013 at two healthcare settings in Barcelona were invited to participate in a prospective survey. We identified process and outcome measures to evaluate this partner notification program, including the number of partners identified per interviewed index case, the proportion of partners tested for HIV as a result of the partner notification, and the proportion of new HIV diagnoses among their sex or needle-sharing partners. Results Of the 125 index cases contacted, 108 (86.4%) agreed to provide information about partners. A total of 199 sexual partners were identified (1.8 partners per interviewed index case). HIV outcome was already known for 58 partners (70.7% were known to be HIV-positive), 141 partners were tested as result of partner notification, and 26 were newly diagnosed with HIV. The case-finding effectiveness of the program was 18.4%. Conclusion This pilot program provides evidence of the effectiveness of a partner notification program implemented in healthcare settings. This active partner notification program was feasible, acceptable to the user, and identified a high proportion of HIV-infected patients previously unaware of their status. PMID:25849451

Effectiveness of a pilot partner notification program for new HIV cases in Barcelona, Spain.

PubMed

Garcia de Olalla, Patricia; Molas, Ema; Barberà, María Jesús; Martín, Silvia; Arellano, Encarnació; Gosch, Mercè; Saladie, Pilar; Carbonell, Teresa; Knobel, Hernando; Diez, Elia; Caylà, Joan A

2015-01-01

An estimated 30% of HIV cases in the European Union are not aware of their serological status. This study aimed to assess the effectiveness of a pilot HIV partner notification program. HIV cases diagnosed between January 2012 and June 2013 at two healthcare settings in Barcelona were invited to participate in a prospective survey. We identified process and outcome measures to evaluate this partner notification program, including the number of partners identified per interviewed index case, the proportion of partners tested for HIV as a result of the partner notification, and the proportion of new HIV diagnoses among their sex or needle-sharing partners. Of the 125 index cases contacted, 108 (86.4%) agreed to provide information about partners. A total of 199 sexual partners were identified (1.8 partners per interviewed index case). HIV outcome was already known for 58 partners (70.7% were known to be HIV-positive), 141 partners were tested as result of partner notification, and 26 were newly diagnosed with HIV. The case-finding effectiveness of the program was 18.4%. This pilot program provides evidence of the effectiveness of a partner notification program implemented in healthcare settings. This active partner notification program was feasible, acceptable to the user, and identified a high proportion of HIV-infected patients previously unaware of their status.

Payment Reform Pilot In Beijing Hospitals Reduced Expenditures And Out-Of-Pocket Payments Per Admission.

PubMed

Jian, Weiyan; Lu, Ming; Chan, Kit Yee; Poon, Adrienne N; Han, Wei; Hu, Mu; Yip, Winnie

2015-10-01

In 2009 China announced plans to reform provider payment methods at public hospitals by moving from fee-for-service (FFS) to prospective and aggregated payment methods that included the use of diagnosis-related groups (DRGs) to control health expenditures. In October 2011 health policy makers selected six Beijing hospitals to pioneer the first DRG payment system in China. We used hospital discharge data from the six pilot hospitals and eight other hospitals, which continued to use FFS and served as controls, from the period 2010-12 to evaluate the pilot's impact on cost containment through a difference-in-differences methods design. Our study found that DRG payment led to reductions of 6.2 percent and 10.5 percent, respectively, in health expenditures and out-of-pocket payments by patients per hospital admission. We did not find evidence of any increase in hospital readmission rates or cost shifting from cases eligible for DRG payment to ineligible cases. However, hospitals continued to use FFS payments for patients who were older and had more complications than other patients, which reduced the effectiveness of payment reform. Continuous evidence-based monitoring and evaluation linked with adequate management systems are necessary to enable China and other low- and middle-income countries to broadly implement DRGs and refine payment systems. Project HOPE—The People-to-People Health Foundation, Inc.

Once-daily, oral levofloxacin monotherapy for low-risk neutropenic fever in cancer patients: a pilot study in China

PubMed Central

He, Lixian; Zhao, Su; Weng, Heng; Yang, Guowang

2015-01-01

This pilot study assesses the safety and efficacy of once-daily, oral levofloxacin monotherapy in Chinese patients with low-risk febrile neutropenia. In this prospective, single-arm, open-label, multicenter clinical trial, 46 adult Chinese patients with solid tumors and low-risk febrile neutropenia were included. Patients received oral levofloxacin monotherapy (500 mg orally/day) until day 12, followed by 7 days of follow-up (day 19). Body temperature was measured three times per day. On days 2, 3, 5–7, 9, 12, and 19, disease symptoms and vital signs were recorded, adverse drug reactions were assessed, and blood samples were collected to determine the whole-blood cell count and the absolute neutrophil count. Blood cultures and chest radiographs were performed simultaneously until negative results were found. Oral levofloxacin was effective and well tolerated in 97.6% of patients irrespective of the cancer type and cause of fever. Body temperature began to decline in 24.4, 68.3, and 90.2% of patients, respectively, at 12, 24, and 48 h after initiating levofloxacin therapy. On days 5 and 7, 95.1 and 97.6% of the patients had complete defervescence, respectively. The median time for absolute neutrophil count recovery to at least 1500/mm3 after initiation of treatment was 3 days. Only one patient reported mild diarrhea. This pilot study showed that oral levofloxacin quickly and effectively reduced fever, initiated neutrophil recovery, and was well tolerated in Chinese low-risk febrile neutropenic patients with solid tumors. Further study is needed to compare patient data of levofloxacin with the standard amoxicillin/ciprofloxacin protocol in this population for both safety and efficacy. PMID:25486597

Therapeutic effect of intranasal evaporative cooling in patients with migraine: a pilot study.

PubMed

Vanderpol, Jitka; Bishop, Barbara; Matharu, Manjit; Glencorse, Mark

2015-01-26

Cryotherapy is the most common non-pharmacological pain-relieving method. The aim of this pilot study was to ascertain whether intranasal evaporative cooling may be an effective intervention in an acute migraine attack. Studies have previously demonstrated effectiveness of a variety of cryotherapy approaches. Intranasal evaporative cooling due to vascular anatomy, allows the transfer of venous blood from nasal and paranasal mucous membranes to the dura mater, thereby providing an excellent anatomical basis for the cooling processes. We conducted a prospective, open-label, observational, pilot study. Twenty-eight patients who satisfied the International Classification of Headache Disorders (ICHD 2) diagnostic criteria for migraine were recruited. A total of 20 treatments were administered in 15 patients. All patients provided pain severity scores and migraine-associated symptoms severity scores (based on a 0-10 visual analogue scale, [VAS]). Out of the 20 treatments, intranasal evaporative cooling rendered patients' pain and symptoms free immediately after treatment, in 8 of the treatments (40%), a further 10 treatments (50%) resulted in partial pain relief (headache reduced from severe or moderate to mild) and partial symptoms relief. At 2 hours, 9 treatments (45%) provided full pain and symptoms relief, with a further 9 treatments (45%) resulting in partial pain and symptoms relief. At 24 hours, 10 treatments (50%) resulted in patients reporting pain and symptom freedom and 3 (15%) provided partial pain relief. In summary 13 patients (87%) had benefit from the treatment within 2 hours that was sustained at 24 hours. Intranasal evaporative cooling gave considerable benefit to patients with migraine, improving headache severity and migraine-associated symptoms. A further randomised, placebo controlled, double blinded, parallel clinical trial is required to further investigate the potential of this application. Clinicaltrials.gov registered trial, ClinicalTrials.gov Identifier: NCT01898455.

Cryopreserved human amniotic membrane injection for plantar fasciitis: a randomized, controlled, double-blind pilot study.

PubMed

Hanselman, Andrew E; Tidwell, John E; Santrock, Robert D

2015-02-01

Treatment options for plantar fasciitis have resulted in varied patient outcomes. The aim of this study was to compare a novel treatment, cryopreserved human amniotic membrane (c-hAM), to a traditional treatment, corticosteroid. Our hypothesis was that c-hAM would be safe and comparable to corticosteroids for plantar fasciitis in regard to patient outcomes. A randomized, controlled, double-blind, single-center pilot study was completed. Patients were randomized into one of 2 treatment groups: c-hAM or corticosteroid. Patients received an injection at their initial baseline visit with an option for a second injection at their first 6-week follow-up. Total follow-up was obtained for 12 weeks after the most recent injection. The primary outcome measurement was the Foot Health Status Questionnaire (FHSQ). The secondary outcome measurements were the Visual Analog Scale (VAS) and verbally reported percentage improvement. Data were analyzed between groups for the 2 different cohorts (1 injection versus 2 injections). Twenty-three patients had complete follow-up. Fourteen were randomized to receive corticosteroid and 9 were randomized to receive c-hAM. Three patients in each group received second injections. With the numbers available, the majority of outcome measurements showed no statistical difference between groups. The corticosteroid did, however, have greater FHSQ shoe fit improvement (P = .0244) at 6 weeks, FHSQ general health improvement (P = .0132) at 6 weeks, and verbally reported improvement (P = .041) at 12 weeks in the one-injection cohort. Cryopreserved hAM had greater FHSQ foot pain improvement (P = .0113) at 18 weeks in the 2-injection cohort. Cryopreserved hAM injection may be safe and comparable to corticosteroid injection for treatment of plantar fasciitis. This is a pilot study and requires further investigation. Level I, prospective randomized trial. © The Author(s) 2014.

In-vivo evaluation of the kinematic behavior of an artificial medial meniscus implant: A pilot study using open-MRI.

PubMed

De Coninck, Tineke; Elsner, Jonathan J; Linder-Ganz, Eran; Cromheecke, Michiel; Shemesh, Maoz; Huysse, Wouter; Verdonk, René; Verstraete, Koenraad; Verdonk, Peter

2014-09-01

In this pilot study we wanted to evaluate the kinematics of a knee implanted with an artificial polycarbonate-urethane meniscus device, designed for medial meniscus replacement. The static kinematic behavior of the implant was compared to the natural medial meniscus of the non-operated knee. A second goal was to evaluate the motion pattern, the radial displacement and the deformation of the meniscal implant. Three patients with a polycarbonate-urethane implant were included in this prospective study. An open-MRI was used to track the location of the implant during static weight-bearing conditions, within a range of motion of 0° to 120° knee flexion. Knee kinematics were evaluated by measuring the tibiofemoral contact points and femoral roll-back. Meniscus measurements (both natural and artificial) included anterior-posterior meniscal movement, radial displacement, and meniscal height. No difference (P>0.05) was demonstrated in femoral roll-back and tibiofemoral contact points during knee flexion between the implanted and the non-operated knees. Meniscal measurements showed no significant difference in radial displacement and meniscal height (P>0.05) at all flexion angles, in both the implanted and non-operated knees. A significant difference (P ≤ 0.05) in anterior-posterior movement during flexion was observed between the two groups. In this pilot study, the artificial polycarbonate-urethane implant, indicated for medial meniscus replacement, had no influence on femoral roll-back and tibiofemoral contact points, thus suggesting that the joint maintains its static kinematic properties after implantation. Radial displacement and meniscal height were not different, but anterior-posterior movement was slightly different between the implant and the normal meniscus. Copyright © 2014 Elsevier Ltd. All rights reserved.

Oxidative stress biomarkers in pediatric sepsis: a prospective observational pilot study.

PubMed

Molina, Víctor; von Dessauer, Bettina; Rodrigo, Ramón; Carvajal, Cristian

2017-11-01

Oxidative stress is known to participate in the progression of sepsis. Definite data regarding the behavior of oxidative stress biomarkers in pediatric sepsis is still lacking. This study hypothesized that oxidative stress occurs in pediatric sepsis and that the magnitude of the redox derangement is associated with worse clinical progression. Forty-two previously healthy pediatric patients with sepsis and a group of control subjects were included. Oxidative stress and inflammatory activity biomarkers were determined in blood samples. Patients were prospectively followed until their discharge or death. Patients with non-severe and severe sepsis showed higher levels of plasmatic antioxidant capacity, lower erythrocyte thiol index, lower superoxide dismutase and catalase activities, higher glutathione peroxidase activity, and higher plasmatic F 2 -isoprostanes concentration than controls. Patients with severe sepsis had higher NF-kappaB activation than those with non-severe sepsis. Although we observed changes in some biomarkers in patients with worse clinical evolution, the explored biomarkers did not correlate with clinical estimators of outcome. Oxidative stress occurs in pediatric sepsis, resulting in oxidative damage. The explored biomarkers are not useful as outcome predictors in the studied population. The behavior of these biomarkers still needs to be addressed in broader groups of pediatric patients with sepsis.

Surgical treatment of gastroesophageal reflux disease and upside-down stomach using the Da Vinci robotic system. A prospective study.

PubMed

Hartmann, Jens; Jacobi, Christoph A; Menenakos, Charalambos; Ismail, Mahmoud; Braumann, Chris

2008-03-01

So far, the impact of telematic surgical approach in Gastroesophageal Reflux Disease (GERD) is still obscure. In this prospective study, we analyzed the Da Vinci Intuitive Surgical robotic system for antireflux surgery. In April 2003, we set up a pilot study to evaluate the efficacy of laparoscopic telerobotic surgery using the three-arm Da Vinci system. Optimal trocar positions, operating and setup times, conversion rate, intraoperative complications, and perioperative morbidity, as well as mortality rate, were analyzed. The median age was 53 years (range 25-74) in 118 patients (52 female/66 male). In 17 patients, an upside-down stomach- and in 101 GERD was surgical indication. The median operating time has been reduced from 105 min to 91 min after 40 procedures and setup time from 24.5 min to 10.4 min after 10 procedures. The system is safe and it seems to be superior to traditional laparoscopy during dissection in the esophageal hiatus region. This compensates long setup- and operating times. Disadvantages are the high costs, the time to master the setup/system and the necessity of exact trocar positioning.

Development of the National Health Information Systems in Botswana: Pitfalls, prospects and lessons.

PubMed

Seitio-Kgokgwe, Onalenna; Gauld, Robin D C; Hill, Philip C; Barnett, Pauline

2015-01-01

Studies evaluating development of health information systems in developing countries are limited. Most of the available studies are based on pilot projects or cross-sectional studies. We took a longitudinal approach to analysing the development of Botswana's health information systems. We aimed to: (i) trace the development of the national health information systems in Botswana (ii) identify pitfalls during development and prospects that could be maximized to strengthen the system; and (iii) draw lessons for Botswana and other countries working on establishing or improving their health information systems. This article is based on data collected through document analysis and key informant interviews with policy makers, senior managers and staff of the Ministry of Health and senior officers from various stakeholder organizations. Lack of central coordination, weak leadership, weak policy and regulatory frameworks, and inadequate resources limited development of the national health information systems in Botswana. Lack of attention to issues of organizational structure is one of the major pitfalls. The ongoing reorganization of the Ministry of Health provides opportunity to reposition the health information system function. The current efforts including development of the health information management policy and plan could enhance the health information management system.

Can computer-aided diagnosis (CAD) help radiologists find mammographically missed screening cancers?

NASA Astrophysics Data System (ADS)

Nishikawa, Robert M.; Giger, Maryellen L.; Schmidt, Robert A.; Papaioannou, John

2001-06-01

We present data from a pilot observer study whose goal is design a study to test the hypothesis that computer-aided diagnosis (CAD) can improve radiologists' performance in reading screening mammograms. In a prospective evaluation of our computer detection schemes, we have analyzed over 12,000 clinical exams. Retrospective review of the negative screening mammograms for all cancer cases found an indication of the cancer in 23 of these negative cases. The computer found 54% of these in our prospective testing. We added to these cases normal exams to create a dataset of 75 cases. Four radiologists experienced in mammography read the cases and gave their BI-RADS assessment and their confidence that the patient should be called back for diagnostic mammography. They did so once reading the films only and a second time reading with the computer aid. Three radiologists had no change in area under the ROC curve (mean Az of 0.73) and one improved from 0.73 to 0.78, but this difference failed to reach statistical significance (p equals 0.23). These data are being used to plan a larger more powerful study.

Age, gender, neck circumference, and Epworth sleepiness scale do not predict obstructive sleep apnea (OSA) in moderate to severe chronic obstructive pulmonary disease (COPD): The challenge to predict OSA in advanced COPD.

PubMed

Soler, Xavier; Liao, Shu-Yi; Marin, Jose Maria; Lorenzi-Filho, Geraldo; Jen, Rachel; DeYoung, Pamela; Owens, Robert L; Ries, Andrew L; Malhotra, Atul

2017-01-01

The combination of chronic obstructive pulmonary disease (COPD) and obstructive sleep apnea (OSA) is associated with substantial morbidity and mortality. We hypothesized that predictors of OSA among patients with COPD may be distinct from OSA in the general population. Therefore, we investigated associations between traditional OSA risk factors (e.g. age), and sleep questionnaires [e.g. Epworth Sleepiness Scale] in 44 patients with advanced COPD. As a second aim we proposed a pilot, simplified screening test for OSA in patients with COPD. In a prospective, observational study of patients enrolled in the UCSD Pulmonary Rehabilitation Program we collected baseline characteristics, cardiovascular events (e.g. atrial fibrillation), and sleep questionnaires [e.g. Pittsburgh Sleep Quality Index (PSQI)]. For the pilot questionnaire, a BMI ≥25 kg/m2 and the presence of cardiovascular disease were used to construct the pilot screening test. Male: 59%; OSA 66%. FEV1 (mean ± SD) = 41.0±18.2% pred., FEV1/FVC = 41.5±12.7%]. Male gender, older age, and large neck circumference were not associated with OSA. Also, Epworth Sleepiness Scale and the STOP-Bang questionnaire were not associated with OSA in univariate logistic regression. In contrast, BMI ≥25 kg/m2 (OR = 3.94, p = 0.04) and diagnosis of cardiovascular disease (OR = 5.06, p = 0.03) were significantly associated with OSA [area under curve (AUC) = 0.74]. The pilot COPD-OSA test (OR = 5.28, p = 0.05) and STOP-Bang questionnaire (OR = 5.13, p = 0.03) were both associated with OSA in Receiver Operating Characteristics (ROC) analysis. The COPD-OSA test had the best AUC (0.74), sensitivity (92%), and specificity (83%). A ten-fold cross-validation validated our results. We found that traditional OSA predictors (e.g. gender, Epworth score) did not perform well in patients with more advanced COPD. Our pilot test may be an easy to implement instrument to screen for OSA. However, a larger validation study is necessary before further clinical implementation is warranted.

Age, gender, neck circumference, and Epworth sleepiness scale do not predict obstructive sleep apnea (OSA) in moderate to severe chronic obstructive pulmonary disease (COPD): The challenge to predict OSA in advanced COPD

PubMed Central

Marin, Jose Maria; Lorenzi-Filho, Geraldo; Jen, Rachel; DeYoung, Pamela; Owens, Robert L.; Ries, Andrew L.; Malhotra, Atul

2017-01-01

The combination of chronic obstructive pulmonary disease (COPD) and obstructive sleep apnea (OSA) is associated with substantial morbidity and mortality. We hypothesized that predictors of OSA among patients with COPD may be distinct from OSA in the general population. Therefore, we investigated associations between traditional OSA risk factors (e.g. age), and sleep questionnaires [e.g. Epworth Sleepiness Scale] in 44 patients with advanced COPD. As a second aim we proposed a pilot, simplified screening test for OSA in patients with COPD. In a prospective, observational study of patients enrolled in the UCSD Pulmonary Rehabilitation Program we collected baseline characteristics, cardiovascular events (e.g. atrial fibrillation), and sleep questionnaires [e.g. Pittsburgh Sleep Quality Index (PSQI)]. For the pilot questionnaire, a BMI ≥25 kg/m2 and the presence of cardiovascular disease were used to construct the pilot screening test. Male: 59%; OSA 66%. FEV1 (mean ± SD) = 41.0±18.2% pred., FEV1/FVC = 41.5±12.7%]. Male gender, older age, and large neck circumference were not associated with OSA. Also, Epworth Sleepiness Scale and the STOP-Bang questionnaire were not associated with OSA in univariate logistic regression. In contrast, BMI ≥25 kg/m2 (OR = 3.94, p = 0.04) and diagnosis of cardiovascular disease (OR = 5.06, p = 0.03) were significantly associated with OSA [area under curve (AUC) = 0.74]. The pilot COPD-OSA test (OR = 5.28, p = 0.05) and STOP-Bang questionnaire (OR = 5.13, p = 0.03) were both associated with OSA in Receiver Operating Characteristics (ROC) analysis. The COPD-OSA test had the best AUC (0.74), sensitivity (92%), and specificity (83%). A ten-fold cross-validation validated our results. We found that traditional OSA predictors (e.g. gender, Epworth score) did not perform well in patients with more advanced COPD. Our pilot test may be an easy to implement instrument to screen for OSA. However, a larger validation study is necessary before further clinical implementation is warranted. PMID:28510598

Comparing systemic therapy and cognitive behavioral therapy for social anxiety disorders: study protocol for a randomized controlled pilot trial.

PubMed

Hunger, Christina; Hilzinger, Rebecca; Koch, Theresa; Mander, Johannes; Sander, Anja; Bents, Hinrich; Schweitzer, Jochen

2016-03-31

Social anxiety disorders are among the most prevalent anxiety disorders in the general population. The efficacy of cognitive behavioral therapy (CBT) for social anxiety disorders is well demonstrated. However, only three studies point to the efficacy of systemic therapy (ST) in anxiety disorders, and only two of them especially focus on social anxiety disorders. These ST studies either do not use a good comparator but minimal supportive therapy, they do not use a multi-person ST but a combined therapy, or they do not especially focus on social anxiety disorders but mood and anxiety disorders in general. Though ST was approved as evidence based in Germany for a variety of disorders in 2008, evidence did not include anxiety disorders. This is the first pilot study that will investigate multi-person ST, integrating a broad range of systemic methods, specifically for social anxiety disorders and that will compare ST to the "gold standard" CBT. This article describes the rationale and protocol of a prospective, open, interventive, balanced, bi-centric, pilot randomized controlled trial (RCT). A total of 32 patients with a primary SCID diagnosis of social anxiety disorder will be randomized to either CBT or ST. Both treatments will be manualized. The primary outcome will include social anxiety symptoms at the end of therapy. Therapy will be restricted to no more than 26 hours (primary endpoint). Secondary outcomes will include psychological, social systems and interpersonal functioning, symptom adjustment, and caregiver burden, in addition to change measures, therapist variables and treatment adherence. At the secondary endpoints, 9 and 12 months after the beginning of therapy, we will again assess all outcomes. The study is expected to pilot test a RCT which will be the first to directly compare CBT and multi-person ST, integrating a broad range of systemic methods, for social anxiety disorders, and it will provide empirical evidence for the calculation of the number of patients needed for a confirmatory RCT. ClinicalTrials.gov: NCT02360033 ; date of registration: 21 January 2015.

Low back pain in Norwegian helicopter aircrew.

PubMed

Hansen, O B; Wagstaff, A S

2001-03-01

The size and consequences of low back pain (LBP) in Norwegian helicopter aircrew has been investigated in a retrospective and prospective survey. With 50.5% reporting such pain in a 2-yr period, and Sea King aircrew reporting LBP on on almost half (49.3%) of the missions flown, the magnitude of the problem equals that reported from other air forces. Pilots reported LBP six times more often than other crewmembers and almost half (48.6%) felt the pain influenced the quality of work. This could have flight safety implications. Crewmembers with total flying time over 2,000 h have a significantly higher incidence of sick leave than those with less than 2,000 h. Only 1 pilot out of 10 with total flying time under 500 h had had flight-related LBP.

Spot the difference: Operational event sequence diagrams as a formal method for work allocation in the development of single-pilot operations for commercial aircraft.

PubMed

Harris, Don; Stanton, Neville A; Starr, Alison

2015-01-01

Function Allocation methods are important for the appropriate allocation of tasks between humans and automated systems. It is proposed that Operational Event Sequence Diagrams (OESDs) provide a simple yet rigorous basis upon which allocation of work can be assessed. This is illustrated with respect to a design concept for a passenger aircraft flown by just a single pilot where the objective is to replace or supplement functions normally undertaken by the second pilot with advanced automation. A scenario-based analysis (take off) was used in which there would normally be considerable demands and interactions with the second pilot. The OESD analyses indicate those tasks that would be suitable for allocation to automated assistance on the flight deck and those tasks that are now redundant in this new configuration (something that other formal Function Allocation approaches cannot identify). Furthermore, OESDs are demonstrated to be an easy to apply and flexible approach to the allocation of function in prospective systems. OESDs provide a simple yet rigorous basis upon which allocation of work can be assessed. The technique can deal with the flexible, dynamic allocation of work and the deletion of functions no longer required. This is illustrated using a novel design concept for a single-crew commercial aircraft.

Medicare and Medicaid programs: Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems and Quality Reporting Programs; electronic reporting pilot; Inpatient Rehabilitation Facilities Quality Reporting Program; revision to Quality Improvement Organization regulations. Final rule with comment period.

PubMed

2012-11-15

This final rule with comment period revises the Medicare hospital outpatient prospective payment system (OPPS) and the Medicare ambulatory surgical center (ASC) payment system for CY 2013 to implement applicable statutory requirements and changes arising from our continuing experience with these systems. In this final rule with comment period, we describe the changes to the amounts and factors used to determine the payment rates for Medicare services paid under the OPPS and those paid under the ASC payment system. In addition, this final rule with comment period updates and refines the requirements for the Hospital Outpatient Quality Reporting (OQR) Program, the ASC Quality Reporting (ASCQR) Program, and the Inpatient Rehabilitation Facility (IRF) Quality Reporting Program. We are continuing the electronic reporting pilot for the Electronic Health Record (EHR) Incentive Program, and revising the various regulations governing Quality Improvement Organizations (QIOs), including the secure transmittal of electronic medical information, beneficiary complaint resolution and notification processes, and technical changes. The technical changes to the QIO regulations reflect CMS' commitment to the general principles of the President's Executive Order on Regulatory Reform, Executive Order 13563 (January 18, 2011).

An empowerment-based diabetes self-management education program for Hispanic/Latinos: a quasi-experimental pilot study.

PubMed

Peña-Purcell, Ninfa C; Boggess, May M; Jimenez, Natalia

2011-01-01

The purpose of this pilot study was to evaluate the effects of a culturally sensitive, empowerment-based diabetes self-management education program for Spanish-speaking Hispanic/Latinos. A prospective quasi-experimental repeated measures design tested the effectiveness of the ¡Si, Yo Puedo Controlar Mi Diabetes! diabetes self-management education program. In sum, 144 persons residing in 2 Texas counties at the Texas-Mexico border (Starr and Hidalgo) served as participants. Two groups were formed, an intervention and a control (wait list). Clinical (A1C), cognitive, attitudinal, behavioral, and cultural assessments were collected at baseline and 3 months. Demographic characteristics for the intervention and control groups were similar. Both groups were predominately female, low income, older than 40 years, and minimally acculturated. Baseline and posttest findings showed that the intervention group had a significant reduction in A1C values; median difference was 0.3 (n = 45), especially for those with higher baseline values. Participants in the intervention group also improved in their self-efficacy and self-care scores. Findings from the study suggest that additional dissemination of a diabetes self-management education program for Spanish-speaking Hispanic/Latinos is warranted to improve clinical outcomes and associated diabetes self-efficacy and self-care behaviors.

Lung Ultrasound Pattern Is Normal during the Last Gestational Weeks: An Observational Pilot Study.

PubMed

Arbeid, Erik; Demi, Alessio; Brogi, Etrusca; Gori, Elisa; Giusto, Teresa; Soldati, Gino; Vetrugno, Luigi; Giunta, Francesco; Forfori, Francesco

2017-01-01

The normal lung ultrasound (US) pattern during a regular pregnancy has not been evaluated extensively in the current literature. Pregnancy-related changes in the respiratory tract affect maternal predisposition to several respiratory complications; consequently, it is important to differentiate between a physiologic pattern during pregnancy and a pathologic lung pattern, due to respiratory failure. The goal of our study was to assess the normal US lung pattern in women without known comorbidities in the last weeks of pregnancy. We conducted a prospective cross-sectional observational pilot study. Chest wall was examined in 8 areas, 1 scan for each area with women in supine position. One hundred fifty parturients were enrolled during the 36th-38th gestational weeks. None of the participants showed pleural effusion, pneumothorax or lung consolidation. None presented an interstitial syndrome US pattern. One hundred thirteen participants out of 150 (75%) showed A-lines in all the regions. The remaining 25% showed 1 or 2 B-lines in at least 3 regions. Only 2 participants showed 2 positive regions also. We found that, in the majority of the women examined, the lung US pattern matches the physiological pattern in non-pregnant patients. Lung US assessment is a feasible and a helpful diagnostic tool during pregnancy. © 2016 S. Karger AG, Basel.

A pilot feasibility study of the effects of touch therapy on nurses.

PubMed

McElligott, Deborah; Holz, Mary Beth; Carollo, Laurie; Somerville, Susan; Baggett, Margarita; Kuzniewski, Sally; Shi, Qiuhu

2003-01-01

The White House Commission on Complementary Alternative Medicine (CAM) has recommended that safe and effective CAM practices be evaluated to determine their role in maintaining wellness and promoting health. There is little research on individual bodywork/energy therapies and their effects on wellness. The purpose of this pilot study was to assess the effect of AMMA treatments on relaxation and anxiety in staff nurses, and to examine themes describing the nurses' experiences. It was hypothesized that nurses receiving AMMA treatments would demonstrate reduced anxiety, as measured by a Visual Analog Scale (VAS) and increased relaxation, measured by physiologic parameters. The study was designed as a prospective, randomized, blinded clinical trial, with convenience sampling of 24 nurses working 12-hour shifts. While both groups demonstrated decreased anxiety after intervention, the experimental group consistently showed greater differences between pre- and post-treatment anxiety scores. The mean change in physiologic parameters between groups was not significant. Themes derived from a final interview included: importance of touch in nursing care, stress reduction, increased self-awareness, the need for self-care and a new understanding of the mind-body connection. Outcomes suggest the need for further research with a larger population to assess this intervention's impact on anxiety, stress, self-care and caring relationships.

Negative pressure and nanocrystalline silver dressings for nonhealing ulcer: A randomized pilot study.

PubMed

Sáez-Martín, Luis C; García-Martínez, Lourdes; Román-Curto, Concepción; Sánchez-Hernández, Miguel V; Suárez-Fernández, Ricardo M

2015-01-01

Chronic wounds have a high prevalence and wound care, treatment, and prevention consume large quantities of resources. Chronic wounds are a growing challenge for clinicians. A prospective randomized pilot study was conducted to assess the effectiveness in terms of reduction in area and safety of the combined use of negative-pressure wound therapy and nanocrystalline silver dressings as compared to negative pressure wound therapy (NPWT) alone in the management of outpatients with chronic wounds. A total of 17 patients were included in the study, 10 were treated with the combined method and 7 with NPWT. Patients were followed for 6 weeks, with a final assessment at 3 months. Clinical improvement, microbiologic data, and toxicity of silver were evaluated. The antibacterial effects of ionic silver together with the development of granulation tissue promoted by NPWT reduced significantly the median extension of the wound between weeks 3 and 6 of treatment. The combination with silver also reduced bacterial colonization with Pseudomonas aeruginosa and the bacterial load on the surface of the wound. The silver levels correlated positively with the extension of the wound, although in none of the patients' toxic levels were reached. The combination of NPWT with nanocrystalline silver dressings was safe and as effective as NPWT alone. © 2015 by the Wound Healing Society.

Clinical Validation of Therapeutic Drug Monitoring of Imipenem in Spent Effluent in Critically Ill Patients Receiving Continuous Renal Replacement Therapy: A Pilot Study.

PubMed

Wen, Aiping; Li, Zhe; Yu, Junxian; Li, Ren; Cheng, Sheng; Duan, Meili; Bai, Jing

2016-01-01

The primary objective of this pilot study was to investigate whether the therapeutic drug monitoring of imipenem could be performed with spent effluent instead of blood sampling collected from critically ill patients under continuous renal replacement therapy. A prospective open-label study was conducted in a real clinical setting. Both blood and effluent samples were collected pairwise before imipenem administration and 0.5, 1, 1.5, 2, 3, 4, 6, and 8 h after imipenem administration. Plasma and effluent imipenem concentrations were determined by reversed-phase high-performance liquid chromatography with ultraviolet detection. Pharmacokinetic and pharmacodynamic parameters of blood and effluent samples were calculated. Eighty-three paired plasma and effluent samples were obtained from 10 patients. The Pearson correlation coefficient of the imipenem concentrations in plasma and effluent was 0.950 (P<0.0001). The average plasma-to-effluent imipenem concentration ratio was 1.044 (95% confidence interval, 0.975 to 1.114) with Bland-Altman analysis. No statistically significant difference was found in the pharmacokinetic and pharmacodynamic parameters tested in paired plasma and effluent samples with Wilcoxon test. Spent effluent of continuous renal replacement therapy could be used for therapeutic drug monitoring of imipenem instead of blood sampling in critically ill patients.

Anesthesia with topical lidocaine hydrochloride gauzes in acute traumatic wounds in triage, a pilot study.

PubMed

Ridderikhof, Milan L; Leenders, Noukje; Goddijn, Helma; Schep, Niels W; Lirk, Philipp; Goslings, J Carel; Hollmann, Markus W

2016-09-01

Topical application of lidocaine in wounds has been studied in combination with vasoconstrictive additives, but the effect without these additives is unknown. The objective was to examine use of lidocaine-soaked gauzes without vasoconstrictive agents, in traumatic wounds in adult patients, applied in triage. A prospective pilot study was performed during 6 weeks in the Emergency Department of a level 1 trauma center. Wounds of consecutive adult patients were treated with a nursing protocol, consisting of lidocaine hydrochloride administration directly into the wound and leaving a lidocaine-soaked gauze, until wound treatment. Primary outcome was need for infiltration anesthesia. Secondary outcomes were Numerical Rating Scale (NRS) pain scores, adverse events and patient and physician satisfaction. Forty patients with a traumatic wound were included, 85% male with a wound on the arm. Thirty-seven patients needed a painful procedure as wound treatment. When suturing was necessary, 77% required additional infiltration anesthesia. Mean NRS pain scores decreased from 3.3 to 2.2 after application of the lidocaine gauze. No adverse events were recorded. Of the patients, 60% were satisfied with use of the lidocaine gauzes, compared to 40% of physicians. Lidocaine hydrochloride (2%) gauzes without vasoconstrictive additives cannot replace infiltration anesthesia in traumatic wounds. Copyright © 2016 Elsevier Ltd. All rights reserved.

Shear-Wave Elastography for the Preoperative Risk Stratification of Follicular-patterned Lesions of the Thyroid: Diagnostic Accuracy and Optimal Measurement Plane.

PubMed

Samir, Anthony E; Dhyani, Manish; Anvari, Arash; Prescott, Jason; Halpern, Elkan F; Faquin, William C; Stephen, Antonia

2015-11-01

To evaluate the diagnostic accuracy of shear-wave elastography (SWE) for the diagnosis of malignancy in follicular lesions and to identify the optimal SWE measurement plane. The institutional review board approved this HIPAA-compliant, single-institution, prospective pilot study. Subjects scheduled for surgery after a previous fine-needle aspiration report of "atypia of undetermined significance" or "follicular lesion of undetermined significance," "suspicion for follicular neoplasm," or "suspicion for Hurthle cell neoplasm," were enrolled after obtaining informed consent. Subjects underwent conventional ultrasonography (US), Doppler evaluation, and SWE preoperatively, and their predictive value for thyroid malignancy was evaluated relative to the reference standard of surgical pathologic findings. Thirty-five patients (12 men, 23 women) with a mean age of 55 years (range, 23-85 years) and a fine-needle aspiration diagnosis of atypia of undetermined significance or follicular lesion of undetermined significance (n = 16), suspicion for follicular neoplasm (n = 14), and suspicion for Hurthle cell neoplasm (n = 5) were enrolled in the study. Male sex was a statistically significant (P = .02) predictor of malignancy, but age was not. No sonographic morphologic parameter, including nodule size, microcalcification, macrocalcification, halo sign, taller than wide dimension, or hypoechogenicity, was associated with malignancy. Similarly, no Doppler feature, including intranodular vascularity, pulsatility index, resistive index, or peak-systolic velocity, was associated with malignancy. Higher median SWE tissue Young modulus estimates from the transverse insonation plane were associated with malignancy, yielding an area under the receiver operating characteristic curve of 0.81 (95% confidence interval: 0.62, 1.00) for differentiation of malignant from benign nodules. At a cutoff value of 22.3 kPa, sensitivity, specificity, positive predictive value, and negative predictive value of 82%, 88%, 75%, and 91%, respectively, were observed. This prospective pilot study indicates that SWE may be a valuable tool in preoperative malignancy risk assessment of follicular-patterned thyroid nodules. © RSNA, 2015

[A first pilot study on the neonatal screening of primary immunodeficiencies in Spain: TRECS and KRECS identify severe T- and B-cell lymphopenia].

PubMed

Olbrich, P; de Felipe, B; Delgado-Pecellin, C; Rodero, R; Rojas, P; Aguayo, J; Marquez, J; Casanovas, J; Sánchez, B; Lucena, J M; Ybot-Gonzalez, P; Borte, S; Neth, O

2014-11-01

Early diagnosis of primary immunodeficiency such as severe combined immunodeficiency (SCID) and X-linked agammaglobulinemia (XLA) improves outcome of affected infants/children. The measurement of T-cell receptor excision circles (TRECS) and kappa-deleting recombination excision circles (KRECS) can identify neonates with severe T or B-cell lymphopenia. To determine TRECS and KRECS levels from prospectively collected dried blood spot samples (DBS) and to correctly identify severe T and B-cell lymphopenia. Determination of TRECS and KRECS by multiplex PCR from neonates born in two tertiary hospitals in Seville between February 2014 and May 2014. PCR cut-off levels: TRECS<15 copies/μl, KRECS<10 copies/μl, ACTB (β-actin)>1000 copies/μl. Internal (XLA, ataxia telangiectasia) and external (SCID) controls were included. A total of 1068 out of 1088 neonates (mean GA 39 weeks (38-40) and BW 3238g (2930-3520) were enrolled in the study. Mean (median, min/max) copies/μl, were as follows: TRECS 145 (132, 8/503), KRECS 82 (71, 7/381), and ACTB 2838 (2763, 284/7710). Twenty samples (1.87%) were insufficient. Resampling was needed in one neonate (0.09%), subsequently giving a normal result. When using lower cut-offs (TRECS<8 and KRECS<4 copies/μl), all the samples tested were normal and the internal and external controls were correctly identified. This is the first prospective pilot study in Spain using TRECS/KRECS/ACTB-assay, describing the experience and applicability of this method to identify severe lymphopenias. The ideal cut-off remains to be established in our population. Quality of sampling, storage and preparation need to be further improved. Copyright © 2014 Asociación Española de Pediatría. Published by Elsevier Espana. All rights reserved.

Productivity Costs Decrease After Endoscopic Sinus Surgery for Refractory Chronic Rhinosinusitis

PubMed Central

Rudmik, Luke; Smith, Timothy L.; Mace, Jess C.; Schlosser, Rodney J.; Hwang, Peter H.; Soler, Zachary M.

2015-01-01

Objective The primary objective of this pilot study was to define the change in productivity costs following endoscopic sinus surgery (ESS) for chronic rhinosinusitis (CRS). Secondary objectives were to identify CRS-related characteristics that may influence the degree of productivity improvement after ESS. Study Design Prospective, multi-institutional, observational cohort study. Methods The human capital approach was used to define productivity costs. Annual absenteeism, presenteeism, and lost leisure time was quantified to define annual lost productive time (LPT). LPT was monetized using the annual daily wage rates obtained from the 2012 US National Census and the 2013 US Department of Labor statistics. Results 27 patients with refractory CRS who underwent ESS were followed for a mean of 15 [SD 4.0] months (range: 8 – 25 months). Following ESS, there were improvements in annual absenteeism (22 days reduced to 3 days), annual presenteeism (41 days reduced to 19 days), and annual household days lost (12 days reduced to 6 days). Overall, the preoperative productivity costs were reduced after ESS, $9,097 vs. $3,301, respectively (p<0.001). Conclusion Daily productivity is negatively impacted by the presence of CRS. The outcomes from this study provide the first insights into the reduced productivity costs associated with receiving ESS for refractory CRS. Future studies with larger sample sizes will need to validate the results from this pilot study. PMID:26371457

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

PubMed

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

2017-11-29

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

Blood ketones are directly related to fatigue and perceived effort during exercise in overweight adults adhering to low-carbohydrate diets for weight loss: a pilot study.

PubMed

White, Andrea M; Johnston, Carol S; Swan, Pamela D; Tjonn, Sherrie L; Sears, Barry

2007-10-01

Ketogenic diets have been associated with reductions in free-living physical activity, a response that can be counterproductive in individuals trying to lose weight. To explore whether popular low-carbohydrate diets might impact the desire to exercise by raising blood ketone concentrations, fatigue and perceived effort during exercise were compared in untrained, overweight adults adhering to a ketogenic low-carbohydrate diet or to a control diet low in carbohydrate, but not ketogenic (5%, 65%, and 30% or 40%, 30%, and 30% of energy from carbohydrate, fat, and protein, respectively). In this prospective, randomized, 2-week pilot study, all meals and snacks were provided to subjects, and energy intake was strictly controlled to provide approximately 70% of that needed for weight maintenance. At baseline and at the end of week 2, exercise testing was conducted in fasting participants. Weight loss and the reductions in fat mass did not differ by group during the trial. At week 2, blood beta-hydroxybutyrate concentrations were 3.6-fold greater for the ketogenic vs nonketogenic group (P=0.018) and correlated significantly with perceived exercise effort (r2=0.22, P=0.049). Blood beta-hydroxybutyrate was also significantly correlated to feelings of "fatigue" (r=0.458, P=0.049) and to "total mood disturbance" (r=0.551, P=0.015) while exercising. These pilot data indicate that ketogenic, low-carbohydrate diets enhance fatigability and can reduce the desire to exercise in free-living individuals.

Efficacy of a Radiation Absorbing Shield in Reducing Dose to the Interventionalist During Peripheral Endovascular Procedures: A Single Centre Pilot Study

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

Power, S.; Mirza, M.; Thakorlal, A.

PurposeThis prospective pilot study was undertaken to evaluate the feasibility and effectiveness of using a radiation absorbing shield to reduce operator dose from scatter during lower limb endovascular procedures.Materials and MethodsA commercially available bismuth shield system (RADPAD) was used. Sixty consecutive patients undergoing lower limb angioplasty were included. Thirty procedures were performed without the RADPAD (control group) and thirty with the RADPAD (study group). Two separate methods were used to measure dose to a single operator. Thermoluminescent dosimeter (TLD) badges were used to measure hand, eye, and unshielded body dose. A direct dosimeter with digital readout was also used tomore » measure eye and unshielded body dose. To allow for variation between control and study groups, dose per unit time was calculated.ResultsTLD results demonstrated a significant reduction in median body dose per unit time for the study group compared with controls (p = 0.001), corresponding to a mean dose reduction rate of 65 %. Median eye and hand dose per unit time were also reduced in the study group compared with control group, however, this was not statistically significant (p = 0.081 for eye, p = 0.628 for hand). Direct dosimeter readings also showed statistically significant reduction in median unshielded body dose rate for the study group compared with controls (p = 0.037). Eye dose rate was reduced for the study group but this was not statistically significant (p = 0.142).ConclusionInitial results are encouraging. Use of the shield resulted in a statistically significant reduction in unshielded dose to the operator’s body. Measured dose to the eye and hand of operator were also reduced but did not reach statistical significance in this pilot study.« less

A pilot study of the utility of a laboratory-based spinal fixation training program for neurosurgical residents.

PubMed

Sundar, Swetha J; Healy, Andrew T; Kshettry, Varun R; Mroz, Thomas E; Schlenk, Richard; Benzel, Edward C

2016-05-01

OBJECTIVE Pedicle and lateral mass screw placement is technically demanding due to complex 3D spinal anatomy that is not easily visualized. Neurosurgical and orthopedic surgery residents must be properly trained in such procedures, which can be associated with significant complications and associated morbidity. Current training in pedicle and lateral mass screw placement involves didactic teaching and supervised placement in the operating room. The objective of this study was to assess whether teaching residents to place pedicle and lateral mass screws using navigation software, combined with practice using cadaveric specimens and Sawbones models, would improve screw placement accuracy. METHODS This was a single-blinded, prospective, randomized pilot study with 8 junior neurosurgical residents and 2 senior medical students with prior neurosurgery exposure. Both the study group and the level of training-matched control group (each group with 4 level of training-matched residents and 1 senior medical student) were exposed to a standardized didactic education regarding spinal anatomy and screw placement techniques. The study group was exposed to an additional pilot program that included a training session using navigation software combined with cadaveric specimens and accessibility to Sawbones models. RESULTS A statistically significant reduction in overall surgical error was observed in the study group compared with the control group (p = 0.04). Analysis by spinal region demonstrated a significant reduction in surgical error in the thoracic and lumbar regions in the study group compared with controls (p = 0.02 and p = 0.04, respectively). The study group also was observed to place screws more optimally in the cervical, thoracic, and lumbar regions (p = 0.02, p = 0.04, and p = 0.04, respectively). CONCLUSIONS Surgical resident education in pedicle and lateral mass screw placement is a priority for training programs. This study demonstrated that compared with a didactic-only training model, using navigation simulation with cadavers and Sawbones models significantly reduced the number of screw placement errors in a laboratory setting.

Trajectories of abstinence-induced Internet gaming withdrawal symptoms: A prospective pilot study.

PubMed

Kaptsis, Dean; King, Daniel L; Delfabbro, Paul H; Gradisar, Michael

2016-12-01

Internet Gaming Disorder (IGD) is positioned in the appendix of the DSM-5 as a condition requiring further study. The IGD criteria refer to withdrawal symptoms, including irritability, anxiety, or sadness, that follow cessation of Internet gaming (APA, 2013). The aim of this study was to prospectively examine the nature of Internet gaming withdrawal symptoms, if they occur, under gaming abstinence conditions. This study employed a repeated-measures protocol to examine the cognitive-affective reactions of participants undertaking an 84-h Internet gaming abstinence period. The sample included individuals who met the IGD criteria as well as those who regularly played Internet games but did not meet the IGD criteria. Outcome variables included affect (positive and negative), psychological distress (depression, anxiety, stress), and Internet gaming withdrawal symptoms (craving/urge, thoughts about gaming, inability to resist gaming). A total of 24 participants ( M age  = 24.6 years, SD  = 5.8) were recruited from online gaming communities, and completed a series of online surveys before, during, and after abstaining from Massively Multiplayer Online (MMO) games. Both the IGD group and the non-IGD group experienced an abstinence-induced decline in withdrawal symptomatology, negative affect, and psychological distress. The IGD group experienced its largest decline in withdrawal symptomatology within the first 24 h of abstinence. These preliminary data suggest that gaming withdrawal symptoms may follow, at least initially, negative linear and quadratic trends. Further prospective work in larger samples involving longer periods of abstinence is required to verify and expand upon these observations.

Immunization knowledge and practice among Malaysian parents: a questionnaire development and pilot-testing.

PubMed

Awadh, Ammar Ihsan; Hassali, Mohamed Azmi; Al-lela, Omer Qutaiba; Bux, Siti Halimah; Elkalmi, Ramadan M; Hadi, Hazrina

2014-10-27

Parents are the main decision makers for their children vaccinations. This fact makes parents' immunization knowledge and practices as predictor factors for immunization uptake and timeliness. The aim of this pilot study was to develop a reliable and valid instrument in Malaysian language to measure immunization knowledge and practice (KP) of Malaysian parents. A cross-sectional prospective pilot survey was conducted among 88 Malaysian parents who attended public health facilities that provide vaccinations. Translated immunization KP questionnaires (Bahasa Melayu version) were used. Descriptive statistics were applied, face and content validity were assessed, and internal consistency, test-retest reliability, and construct validity were determined. The mean ± standard deviation (SD) of the knowledge scores was 7.36 ± 2.29 and for practice scores was 7.13 ± 2.20. Good internal consistency was found for knowledge and practice items (Cronbach's alpha = 0.757 and 0.743 respectively); the test-retest reliability value was 0.740 (p = 0.014). A panel of three specialist pharmacists who are experts in this field judged the face and content validity of the final questionnaire. Parents with up-to-date immunized children had significantly better knowledge and practice scores than parents who did not (p < 0.001 and p = 0.001 respectively), suggesting a good construct validity. A significant difference was found in knowledge and practice scores among parents' age (p = 0.006 and p = 0.029 respectively) and place of living (p = 0.037 and p = 0.043). The parents' knowledge level was positively associated with their practice toward immunization (Spearman's rank correlation coefficient 0.310, p = 0.003). The pilot study concluded that the Bahasa Melayu version of the immunization KP questionnaire has good reliability and validity for measuring the knowledge and practices of Malaysian parents and therefore this version can be used in future research.

Successful Completion of the Pilot Phase of a Randomized Controlled Trial Comparing Sentinel Lymph Node Biopsy to No Further Axillary Staging in Patients with Clinical T1-T2 N0 Breast Cancer and Normal Axillary Ultrasound

PubMed Central

Cyr, Amy E; Tucker, Natalia; Ademuyiwa, Foluso; Margenthaler, Julie A; Aft, Rebecca L; Eberlein, Timothy J; Appleton, Catherine M; Zoberi, Imran; Thomas, Maria A; Gao, Feng; Gillanders, William E

2016-01-01

Background Axillary surgery is not considered therapeutic in patients with clinical T1-T2 N0 breast cancer. The importance of axillary staging is eroding in an era where tumor biology, as defined by biomarker and gene expression profile, is increasingly important in medical decision making. We hypothesize that axillary ultrasound (AUS) is a noninvasive alternative to sentinel lymph node biopsy (SLNB), and AUS could replace SLNB without compromising patient care. Study Design Patients with clinical T1-T2 N0 breast cancer and normal AUS were eligible for enrollment. Subjects were randomized to no further axillary staging (Arm 1) versus SLNB (Arm 2). Descriptive statistics were used to describe the results of the pilot phase of the randomized controlled trial. Results 68 subjects were enrolled in the pilot phase of the trial (34 subjects in Arm 1, no further staging; 32 subjects in Arm 2, SLNB, and 2 subjects voluntarily withdrew from the trial). The median age was 61 years (range 40-80) in Arm 1 and 59 years (range 31-81) in Arm 2, and there were no significant clinical or pathologic differences between the arms. Median follow-up was 17 months (range 1-32). The negative predictive value (NPV) of AUS for identification of clinically significant axillary disease (> 2.0 mm) was 96.9%. No axillary recurrences have been observed in either arm. Conclusions Successful completion of the pilot phase of the randomized controlled trial confirms the feasibility of the study design, and provides prospective evidence supporting the ability of AUS to exclude clinically significant disease in the axilla. The results provide strong support for a phase 2 randomized controlled trial. PMID:27212005

Targeted full energy and protein delivery in critically ill patients: a study protocol for a pilot randomised control trial (FEED Trial).

PubMed

Fetterplace, Kate; Deane, Adam M; Tierney, Audrey; Beach, Lisa; Knight, Laura D; Rechnitzer, Thomas; Forsyth, Adrienne; Mourtzakis, Marina; Presneill, Jeffrey; MacIsaac, Christopher

2018-01-01

Current guidelines for the provision of protein for critically ill patients are based on incomplete evidence, due to limited data from randomised controlled trials. The present pilot randomised controlled trial is part of a program of work to expand knowledge about the clinical effects of protein delivery to critically ill patients. The primary aim of this pilot study is to determine whether an enteral feeding protocol using a volume target, with additional protein supplementation, delivers a greater amount of protein and energy to mechanically ventilated critically ill patients than a standard nutrition protocol. The secondary aims are to evaluate the potential effects of this feeding strategy on muscle mass and other patient-centred outcomes. This prospective, single-centred, pilot, randomised control trial will include 60 participants who are mechanically ventilated and can be enterally fed. Following informed consent, the participants receiving enteral nutrition in the intensive care unit (ICU) will be allocated using a randomisation algorithm in a 1:1 ratio to the intervention (high-protein daily volume-based feeding protocol, providing 25 kcal/kg and 1.5 g/kg protein) or standard care (hourly rate-based feeding protocol providing 25 kcal/kg and 1 g/kg protein). The co-primary outcomes are the average daily protein and energy delivered to the end of day 15 following randomisation. The secondary outcomes include change in quadriceps muscle layer thickness (QMLT) from baseline (prior to randomisation) to ICU discharge and other nutritional and patient-centred outcomes. This trial aims to examine whether a volume-based feeding protocol with supplemental protein increases protein and energy delivery. The potential effect of such increases on muscle mass loss will be explored. These outcomes will assist in formulating larger randomised control trials to assess mortality and morbidity. Australian New Zealand Clinical Trials Registry (ANZCTR), ACTRN: 12615000876594 UTN: U1111-1172-8563.

Home use of binocular dichoptic video content device for treatment of amblyopia: a pilot study.

PubMed

Mezad-Koursh, Daphna; Rosenblatt, Amir; Newman, Hadas; Stolovitch, Chaim

2018-04-01

To evaluate the efficacy of the BinoVision home system as measured by improvement of visual acuity in the patient's amblyopic eye. An open-label prospective pilot-trial of the system was conducted with amblyopic children aged 4-8 years at the pediatric ophthalmology unit, Tel-Aviv Medical Center, January 2014 to October 2015. Participants were assigned to the study or sham group for treatment with BinoVision for 8 or 12 weeks. Patients were instructed to watch animated television shows and videos at home using the BinoVision device for 60 minutes, 6 days a week. The BinoVision program incorporates elements at different contrast and brightness levels for both eyes, weak eye tracking training by superimposed screen images, and weak eye flicker stimuli with alerting sound manipulations. Patients were examined at 4, 8, 12, 24, and 36 weeks. A total of 27 children were recruited (14 boys), with 19 in the treatment group. Median age was 5 years (range, 4-8 years). Mean visual acuity improved by 0.26 logMAR lines in the treatment group from baseline to 12 weeks. Visual acuity was improved compared to baseline during all study and follow-up appointments (P < 0.01), with stabilization of visual acuity after cessation of treatment. The sham group completed 4 weeks of sham protocol with no change in visual acuity (P = 0.285). The average compliance rate was 88% ± 16% (50% to 100%) in treatment group. This pilot trial of 12 weeks of amblyopia treatment with the BinoVision home system demonstrated significant improvement in patients' visual acuity. Copyright © 2018 American Association for Pediatric Ophthalmology and Strabismus. Published by Elsevier Inc. All rights reserved.

A culturally adapted family intervention for African American families coping with parental cancer: outcomes of a pilot study.

PubMed

Davey, Maureen P; Kissil, Karni; Lynch, Laura; Harmon, La-Rhonda; Hodgson, Nancy

2013-07-01

The primary objective of this 2-year pilot study was to evaluate the effectiveness of a culturally adapted family intervention in improving family communication among African American parents coping with cancer and their school-age children. A secondary objective was to determine its impact on other symptoms of psychosocial distress (depression and anxiety). The third objective was to assess for acceptability and feasibility. Using a two-arm pre-intervention and post-intervention prospective design, 12 African American families received five bi-monthly sessions of either a culturally adapted family intervention (n=7 families) or psycho-education treatment (n=5 families). Parents and their children completed pre-intervention and post-intervention questionnaires assessing perceptions of family communication, quality of their relationship, and symptoms of depression. School-age children additionally completed a questionnaire assessing their levels of anxiety. Consumer satisfaction was also evaluated at post-intervention. Parents and school-age children who completed the culturally adapted family intervention reported significantly better communication with each other and were more satisfied compared with the psycho-education control group. No changes were noted in symptoms of anxiety or depression. The culturally adapted family intervention was acceptable based on our findings, families' feedback, and rates of retention. Feasibility is uncertain because our oncology clinic approach to recruitment was slower than expected. Providing culturally adapted family intervention programs to African American families who are coping with parental cancer may result in improved family communication. This pilot study serves as the first step in the development of culturally adapted family intervention programs to help African American families cope with parental cancer. Copyright © 2012 John Wiley & Sons, Ltd.

A pilot study of inhaled methoxyflurane for procedural analgesia in children.

PubMed

Babl, Franz; Barnett, Peter; Palmer, Greta; Oakley, Ed; Davidson, Andrew

2007-02-01

Methoxyflurane (MF), a potent volatile anesthetic, can be used as an analgesic in subanesthetic concentrations. In Australia, MF is extensively used in children and adults as an analgesic in the prehospital setting via a hand-held inhaler device. We conducted a pilot study to explore its use as a patient controlled analgesic for painful procedures in children in the emergency department (ED). This is a prospective observational case series of children aged 5 years and older requiring procedural analgesia for brief painful procedures. Pain scores, depth of sedation, adverse events and patient, parent and staff satisfaction were assessed as well as consumption of MF measured. Fourteen patients (aged 6-13 years) received MF mainly for extremity injuries. Amount of MF consumed ranged from 0.36 to 3.06 g per patient inhaled over 4-25 min. There were no serious adverse events. No patient was deeply sedated. Five patients had mild brief self-resolving adverse events including agitation, euphoria, blurry vision, dizziness and cough. Four patients with fractures with initial high pain scores (> or =6) received MF for bridging analgesia with large drops in pain scores. Four patients who required fracture reductions with initial low scores did not achieve adequate analgesia. The remaining six patients had painful procedures undertaken with satisfactory analgesia. On the basis of this small pilot study of MF use in children in the ED, this agent appears to be a powerful analgesic. MF seems most useful as a self-titrated bridging analgesic agent in patients after extremity trauma. It appears less useful as a procedural agent when patients are unable to anticipate and achieve a sufficient level of analgesia before painful stimulus infliction. Pre- and intraprocedure coaching is an important aspect of its use especially if initial pain scores are low.

Vitamin K Acupuncture Point Injection for Severe Primary Dysmenorrhea: An International Pilot Study

PubMed Central

Wang, Li; Zhao, Wenjie; Yu, Jin; Cardini, Francesco; Forcella, Emanuela; Regalia, Anna Laura; Wade, Christine

2004-01-01

Context Vitamin K acupuncture point injection, a menstrual pain treatment derived from traditional Chinese medicine, has been a standard treatment in some hospitals in China since the 1980s. Objectives To investigate the effects of vitamin K acupuncture point injection on menstrual pain in young women aged 14 to 25 from different countries and cultural backgrounds who have had unmitigated severe primary dysmenorrhea for 6 months or more Design Prospective, observational, clinical pilot study Settings One site in China (a hospital outpatient clinic in Shanghai) and 2 sites in Italy (a hospital clinic in Milan and a private gynecology practice in Verona) Interventions All subjects were treated with bilateral acupuncture point injection of vitamin K on the first or second day of menstrual pain. Vitamin K3 was used in China and vitamin K4 in Italy. Main Outcome Measures Pain intensity, total duration, and average intensity of menstrual distress, hours in bed, normal daily activity restrictions, and numbers of analgesic tablets taken to relieve pain were recorded before the treatment and for 4 subsequent menstrual cycles. Results Noticeable pain relief was observed 2 minutes after treatment, and subsequent pain reduction occurred at 30 minutes (P < .001). Subjects reported significantly fewer daily life restrictions, fewer hours in bed, less consumption of analgesic tablets, and lower scores of menstrual pain duration and intensity (P < .001). There were no adverse events. Some women experienced mild, self-limited pain at the injection site. Conclusion Acupuncture point injection with vitamin K alleviated acute menstrual pain, and relief extended through the nontreatment follow-up cycles in this uncontrolled pilot study conducted in 2 countries. Further investigation employing controlled experimental designs is warranted. PMID:15775872

Exploratory analysis of glyburide as a novel therapy for preventing brain swelling.

PubMed

Sheth, Kevin N; Kimberly, W Taylor; Elm, Jordan J; Kent, Thomas A; Yoo, Albert J; Thomalla, Götz; Campbell, Bruce; Donnan, Geoffrey A; Davis, Stephen M; Albers, Gregory W; Jacobson, Sven; del Zoppo, Gregory; Simard, J Marc; Stern, Barney J; Mandava, Pitchaiah

2014-08-01

Malignant infarction is characterized by the formation of cerebral edema, and medical treatment is limited. Preclinical data suggest that glyburide, an inhibitor of SUR1-TRPM4, is effective in preventing edema. We previously reported feasibility of the GAMES-Pilot study, a two-center prospective, open label, phase IIa trial of 10 subjects at high risk for malignant infarction based on diffusion weighted imaging (DWI) threshold of 82 cm(3) treated with RP-1127 (glyburide for injection). In this secondary analysis, we tested the hypothesis that RP-1127 may be efficacious in preventing poor outcome when compared to controls. Controls suffering large hemispheric infarction were obtained from the EPITHET and MMI-MRI studies. We first screened subjects for controls with the same DWI threshold used for enrollment into GAMES-Pilot, 82 cm(3). Next, to address imbalances, we applied a weighted Euclidean matching. Ninety day mRS 0-4, rate of decompressive craniectomy, and mortality were the primary clinical outcomes of interest. The mean age of the GAMES cohort was 51 years and initial DWI volume was 102 ± 23 cm(3). After Euclidean matching, GAMES subjects showed similar NIHSS, higher DWI volume, younger age and had mRS 0-4-90% versus 50% in controls p = 0.049; with a similar trend in mRS 0-3 (40 vs. 25%; p = 0.43) and trend toward lower mortality (10 vs. 35%; p = 0.21). In this pilot study, RP-1127-treated subjects showed better clinical outcomes when compared to historical controls. An adequately powered and randomized phase II trial of patients at risk for malignant infarction is needed to evaluate the potential efficacy of RP-1127.

A pilot study investigating the effect of parathyroidectomy on arterial stiffness and coronary artery calcification in patients with primary hyperparathyroidism.

PubMed

Dural, Cem; Okoh, Alexis Kofi; Seicean, Andreea; Yigitbas, Hakan; Thomas, George; Yazici, Pinar; Shoenhagen, Paul; Doshi, Krupa; Halliburton, Sandra; Berber, Eren

2016-01-01

Arterial stiffness (AS) and coronary artery calcification (CAC) are predictors of cardiovascular risk and can be measured noninvasively. The aim of this study was to analyze the effects of parathyroidectomy on AS and CAC in patients with primary hyperparathyroidism (PHP). This prospective, institutional review board-approved study included 21 patients with PHP, who underwent parathyroidectomy. Before and 6 months after parathyroidectomy, AS was assessed by measuring central systolic pressure (CSP), central pulse pressure, augmentation pressure (AP), and augmentation index (AIx); the CAC score (Agatston) was calculated on noncontrast computed tomography. AS parameters were compared with unaffected controls from donor nephrectomy database. Preoperative CSP and AIx parameters in PHP patients were higher than those in donor nephrectomy patients (P = .004 and P = .039, respectively). Preoperative total CAC score was zero in 15 patients (65%) and ranged from the 72nd to the 99th percentile in 6 patients (26%). Although there were no changes in CAC or AS after parathyroidectomy on average, there was variability in individual patient responses on AS. This pilot study demonstrates that CAC is not altered in PHP patients at short-term follow-up after parathyroidectomy. The heterogeneous changes in AS after parathyroidectomy warrant further investigation in a larger study with longer follow-up. Copyright © 2016 Elsevier Inc. All rights reserved.

Investigation of the interplay between plasma lipids and macrophage polarization in small oral squamous cell carcinomas with different outcome: A pilot study of 17 cases.

PubMed

Iliopoulos, Christos; Weber, Manuel; Mitsimponas, Konstantinos T; Neukam, Friedrich W; Wehrhan, Falk

2016-02-01

Growing evidence suggests a correlation of alternative polarization of macrophages (M2) with a bad outcome of oral cancer. Macrophage polarization plays a significant role in the progression of hyperlipidemia and atherosclerosis, being influenced from plasma cholesterol. On the other hand plasma lipids have been studied epidemiologically as risk factors in carcinogenesis. Goal of our pilot study was the investigation of a possible association of plasma lipids with tumor outcome through their potential influence on macrophage polarization. 17 patients with small pN0 OSCC with different clinical outcome, treated operatively without postoperative R(C)T constituted our patient collective. Plasma lipids (total cholesterol and triglycerides) were studied in relation to macrophage polarization (determined through the expression of CD68, CD11c, CD163 and MRC1 antibodies) and tumor outcome. Patients with pathological chronic course of either plasma cholesterol or triglycerides demonstrated an increased infiltration with alternatively polarized macrophages in their specimens. Patients with pathological chronic course of plasma cholesterol showed moreover a bad tumor outcome. A role of plasma lipids in the tumor outcome via alternative macrophage polarization could be assumed. A larger prospective study is needed to confirm our preliminary results. Copyright © 2015 European Association for Cranio-Maxillo-Facial Surgery. Published by Elsevier Ltd. All rights reserved.

Safety and efficacy of overnight orthokeratology in myopic children.

PubMed

Mika, Renée; Morgan, Bruce; Cron, Michael; Lotoczky, Josh; Pole, John

2007-05-01

This prospective case series was conducted to describe the safety and efficacy of orthokeratology with the Emerald Contact Lens for Overnight Orthokeratology (Oprifocon A; Euclid Systems Corporation, Herndon, Virginia) among young myopes. Twenty subjects (ages 10 to 16) were enrolled in the 6-month pilot study. Subjects were fit empirically with overnight orthokeratology lenses and evaluated at 1 day, 1 week, 1 month, 2 months, 3 months, and 6 months. Sixteen subjects completed the study. The mean baseline spherical equivalent refraction (SER) was -2.06 diopters (D) (+/-0.75). The mean SER at 6 months was -0.16 D (+/-0.38). The mean baseline uncorrected acuity was 0.78 (+/-0.28) logarithmic minimum angle of resolution (logMAR) equivalent (20/100 Snellen). The mean logMAR equivalent at 6 months was -0.03 +/- 0.12 (<20/20 Snellen). On average, 40% of eyes showed some type of corneal staining between the 1-week and 6-month visits. No serious adverse events occurred during the study. In contrast to previously published studies that reported maximum results at 2 weeks, subjects reached maximum reduction in myopia at the 1-week visit and, on average, obtained a 92.2% reduction in spherical equivalent refractive error at 6 months. This pilot study lends to a growing body of evidence that short-term correction of mild to moderate myopia with overnight orthokeratology is safe and efficacious in children and adolescents.

Productivity costs decrease after endoscopic sinus surgery for refractory chronic rhinosinusitis.

PubMed

Rudmik, Luke; Smith, Timothy L; Mace, Jess C; Schlosser, Rodney J; Hwang, Peter H; Soler, Zachary M

2016-03-01

The primary objective of this pilot study was to define the change in productivity costs following endoscopic sinus surgery (ESS) for chronic rhinosinusitis (CRS). Secondary objectives were to identify CRS-related characteristics that may influence the degree of productivity improvement after ESS. Prospective, multi-institutional, observational cohort study. The human capital approach was used to define productivity costs. Annual absenteeism, presenteeism, and lost leisure time were quantified to define annual lost productive time (LPT). LPT was monetized using the annual daily wage rates obtained from the 2012 US Census and the 2013 US Department of Labor statistics. Twenty-seven patients with refractory CRS who underwent ESS were followed for a mean of 15 months (range, 8-25 months). Following ESS, there were improvements in annual absenteeism (22 days reduced to 3 days), annual presenteeism (41 days reduced to 19 days), and annual household days lost (12 days reduced to 6 days). Overall, the preoperative productivity costs were reduced after ESS ($9,190 vs. $3,373, respectively; P < .001). Daily productivity is negatively impacted by the presence of CRS. The outcomes from this study provide the first insights into the reduced productivity costs associated with receiving ESS for refractory CRS. Future studies with larger sample sizes will need to validate the results from this pilot study. 2c Laryngoscope, 126:570-574, 2016. © 2015 The American Laryngological, Rhinological and Otological Society, Inc.

COOL-ARREST: Results from a Pilot Multicenter, Prospective, Single-Arm Observational Trial to Assess Intravascular Temperature Management in the Treatment of Cardiac Arrest.

PubMed

Sawyer, Kelly N; Mooney, Michael; Norris, Gregory; Devlin, Thomas; Lundbye, Justin; Doshi, Pratik B; Hewett, Jonathan Kyle; Kono, Alan T; Jorgensen, Jesse P; O'Neil, Brian J

2018-06-08

Targeted temperature management (TTM) is recommended postcardiac arrest. The cooling method with the highest safety and efficacy is unknown. The COOL-ARREST pilot trial aimed to evaluate the safety and efficacy of the most contemporary ZOLL Thermogard XP Intravascular Temperature Management (IVTM) system for providing mild TTM postcardiac arrest. This multicenter, prospective, single-arm, observational pilot trial enrolled patients at eight U.S. hospitals between July 28, 2014, and July 24, 2015. Adult (≥18 years old), out-of-hospital cardiac arrest subjects of presumed cardiac etiology who achieved return of spontaneous circulation (ROSC) were considered for inclusion. Patients were excluded if (1) awake or consistently following commands after ROSC, (2) significant prearrest neurological dysfunction, (3) terminal illness or advanced directives precluding aggressive care, and (4) severe hemodynamic instability or shock. Patient temperature was maintained at 33.0°C ± 0.3°C for a total of 24 hours followed by controlled rewarming (0.1-0.2°C/h). Logistic regressions were used to assess association of good functional outcome (modified Rankin Scale ≤3) measured at the time of hospital discharge with shockable rhythm (yes/no), age, gender, race/ethnicity, lay-rescuer cardiopulmonary resuscitation, time to basic life support (minutes), time to ROSC (minutes), lactate (mg/dL), and pH on admission. The ZOLL IVTM system was effective at inducing TTM (median time to target temperature from initiation, 89 minutes [interquartile range 42-155]). Adverse events most often included electrolyte abnormalities and dysrhythmias. Of patients surviving to hospital discharge, 16/20 patients had a good functional outcome. A total of 18 patients survived through 90-day follow-up, at which time 94% (17/18) of patients had good functional outcome. The COOL-ARREST pilot trial demonstrates high safety and efficacy of the ZOLL Thermogard XP IVTM system in the application of mild TTM postcardiac arrest. This observational trial also revealed noteworthy variability in the management of postcardiac arrest patients, particularly with the use of early withdrawal of life-sustaining therapy.

A pilot study of sphincter-sparing management of adenocarcinoma of the rectum.

PubMed

Steele, G; Busse, P; Huberman, M S; LeClair, J M; Falchuk, Z M; Mayer, R J; Bothe, A; Ravikumar, T S; Stone, M; Jessup, J M

1991-06-01

After analysis of 26 prospectively accrued patients with distal rectal adenocarcinomas who underwent sphincter preservation treatment, we have concluded that tumors that invade only the submucosa can safely be treated with surgery alone and that tumors that invade the muscularis or further can be safely treated with surgery combined with chemoradiotherapy. None of the patients had either local or distant recurrence, with a median follow-up of 21 months. All patients have been fully continent. The results, although preliminary, imply that resection of distal rectal adenocarcinoma with sphincter preservation, and adjuvant therapy when appropriate, have achieved local and distant control equal to the conventional Miles' abdominoperineal resection, but without the need for a permanent colostomy.

Surgical planning and microvascular reconstruction of the mandible with a fibular flap using computer-aided design, rapid prototype modelling, and precontoured titanium reconstruction plates: a prospective study.

PubMed

Sieira Gil, R; Roig, A Marí; Obispo, C Arranz; Morla, A; Pagès, C Martí; Perez, J Llopis

2015-01-01

The standard of mandibular reconstruction has increased since the introduction of computer-assisted design (CAD) and rapid prototype modelling (RPM) for surgical planning. Between 2008 and 2013, a prospective pilot study of 20 patients was planned to compare the outcomes of patients treated by mandibular reconstruction who had CAD and RPM-guided operations using a precontoured titanium plate, with the outcomes of patients treated conventionally. We recorded the time taken for reconstruction, total operating time, and whether this type of planning could improve the results of mandibular reconstruction. We found significant differences in the incidence of dental malocclusion (p=0.03) and exposure of the titanium plate (p=0.009). The mean operating time for reconstruction in the preoperative planning group was 135 (37)min compared with 176 (58)min in the conventional group (p=0.04). Preoperative planning using CAD and RPM can increase the accuracy of microvascular mandibular reconstruction and reduce the operating time for reconstruction. Copyright © 2014 The British Association of Oral and Maxillofacial Surgeons. Published by Elsevier Ltd. All rights reserved.

Fibromyalgia with Gabapentin and Osteopathic Manipulative Medicine: A Pilot Study.

PubMed

Marske, Cynthia; Bernard, Natasha; Palacios, Alison; Wheeler, Cary; Preiss, Ben; Brown, Mackenzie; Bhattacharya, Saveri; Klapstein, Gloria

2018-04-01

This pilot study compares the safety and efficacy of three treatments in reducing pain and improving fibromyalgia symptoms. This study was an 8-week prospective, single center feasibility study. Forty subjects were recruited from Solano, Sonoma, and Contra Costa counties of California in 2006-2009. Subjects were aged 18-65 and met the American College of Rheumatology (ACR) 1990 criteria for fibromyalgia. This study had three treatment arms: gabapentin only (900 mg/day), osteopathic manipulative medicine (OMM) only, and combined treatment of gabapentin plus OMM. OMM treatment was administered by advanced medical students for 30 min, once a week. The trial lasted for 8 weeks, which included 6 weeks of treatment plus initial and final visits. Key outcome measures included Wong-Baker FACES Pain Rating Scale (WBF), Clinical Global Impression of Health (CGI), Fibromyalgia Impact Questionnaire (FIQ), and number of tender points. Twenty-nine subjects completed the trial; 8 subjects received gabapentin only, 11 patients received OMM only, and 10 patients received gabapentin plus OMM. Subjects receiving OMM alone and subjects receiving the combined treatment of OMM and gabapentin displayed clinical improvements based on WBF (p < 0.01 and p = 0.03, respectively), while the change among the gabapentin-only group was nonsignificant. The OMM only group was the only group to experience a significant decline in CGI scale (p < 0.01). No statistically significant changes were observed with the FIQ or number of tender points. No differences across groups were statistically significant. This is to be expected in a feasibility study with a small sample size. This pilot study suggests that OMM treatment and gabapentin are safe and clinically efficacious treatment of pain and other constitutional and somatic symptoms associated with fibromyalgia. A larger trial using the new ACR 2010 Fibromyalgia criteria is needed to confirm these findings.

Overcoming the tyranny of distance: An audit of process and outcomes from a pilot telehealth spinal assessment clinic.

PubMed

Beard, Matthew; Orlando, Joseph F; Kumar, Saravana

2017-09-01

Introduction There is consistent evidence to indicate people living in rural and remote regions have limited access to healthcare and poorer health outcomes. One way to address this inequity is through innovative models of care such as telehealth. The aim of this pilot trial was to determine the feasibility, appropriateness and access to a telehealth clinic. In this pilot trial, the telehealth clinic outcomes are compared with the outreach clinic. Both models of care are commonly utilised means of providing healthcare to meet the needs of people living in rural and remote regions. Methods A prospective audit was conducted on a Spinal Assessment Clinic Telehealth pilot trial for patients with spinal disorders requiring non-urgent surgical consultation. Data were recorded from all consultations managed using videoconferencing technology between the Royal Adelaide Hospital and Port Augusta Community Health Service, South Australia between September 2013 and January 2014. Outcomes included analysis of process, service activity, clinical actions, safety and costs. Data were compared to a previous spinal assessment outreach clinic in the same area between August and December 2012. Results There were 25 consultations with 22 patients over the five-month telehealth pilot trial. Spinal disorders were predominantly of the lumbar region (88%); the majority of initial consultations (64%) were discharged to the general practitioner. There were three requests for further imaging, five for minor interventions and three for other specialist/surgical consultation. Patient follow-up post telehealth pilot trial revealed no adverse outcomes. The total cost of AUD$11,187 demonstrated a 23% reduction in favour of the spinal assessment telehealth pilot trial, with the greatest savings in travel costs. Discussion The telehealth model of care demonstrated the efficient management of patients with spinal disorders in rural regions requiring non-urgent surgical consultation at low costs with no adverse outcomes reported.

Statistical Application and Cost Saving in a Dental Survey.

PubMed

Chyou, Po-Huang; Schroeder, Dixie; Schwei, Kelsey; Acharya, Amit

2017-06-01

To effectively achieve a robust survey response rate in a timely manner, an alternative approach to survey distribution, informed by statistical modeling, was applied to efficiently and cost-effectively achieve the targeted rate of return. A prospective environmental scan surveying adoption of health information technology utilization within their practices was undertaken in a national pool of dental professionals (N=8000) using an alternative method of sampling. The piloted approach to rate of cohort sampling targeted a response rate of 400 completed surveys from among randomly targeted eligible providers who were contacted using replicated subsampling leveraging mailed surveys. Two replicated subsample mailings (n=1000 surveys/mailings) were undertaken to project the true response rate and estimate the total number of surveys required to achieve the final target. Cost effectiveness and non-response bias analyses were performed. The final mailing required approximately 24% fewer mailings compared to targeting of the entire cohort, with a final survey capture exceeding the expected target. An estimated $5000 in cost savings was projected by applying the alternative approach. Non-response analyses found no evidence of bias relative to demographics, practice demographics, or topically-related survey questions. The outcome of this pilot study suggests that this approach to survey studies will accomplish targeted enrollment in a cost effective manner. Future studies are needed to validate this approach in the context of other survey studies. © 2017 Marshfield Clinic.

Nephroprotection with saxagliptin.

PubMed

Iazzetta, Nicolangelo; Garofalo, Carlo; Savino, Manuela; Sagliocca, Adelia; Santangelo, Sara; Pacilio, Mario; Liberti, Maria Elena; Camocardi, Andrea; Ambrosca, Camilla; Minutolo, Roberto; De Nicola, Luca; Conte, Giuseppe

2015-01-01

The nephroprotective effect of the new anti-diabetic drugs acting on incretin system is suggested by preclinical studies. However, no study evaluating kidney effects of these drugs as primary outcome on the long term has been conducted in patients followed in diabetes centers. We designed a pilot observational study involving two diabetes clinics to evaluate the effect of prolonged treatment with saxagliptin on renal function in type 2 diabetics. Patients were enrolled if treated for at least 12 months with saxagliptin without concurrent changes to anti-hypertensive and lipid-lowering therapy. Primary outcome was to evaluate the effect of saxagliptin on albuminuria and estimated glomerular filtration rate (eGFR). Secondary outcomes were the effects of treatment on common clinical and laboratory parameters. Sixty-three patients were enrolled. After 12 months of treatment with saxagliptin, albuminuria declined from a mean (95%CI) of 39 (25-52) to 22 (14-30) mg/l (P<0.001), and the prevalence of increased albuminuria (>20 mg/L) diminished by 27% versus baseline. The anti-albuminuric effect was independent of glycemic and blood pressure control. The eGFR remained unchanged after treatment in the presence of decreased glycated hemoglobin (from 7.1 to 6.7%). Therefore, this pilot study suggests that saxagliptin treatment in diabetic patients at high renal risk is associated with a reduction in albuminuria and GFR stability. Prospective trials are required to confirm the potential nephroprotective effects of saxagliptin.

Ergonomic task analysis of ultrasound-guided femoral nerve block: a pilot study.

PubMed

Ajmal, Muhammad; Power, Susan; Smith, Tim; Shorten, George D

2011-02-01

To apply ergonomic task analysis to the performance of ultrasound-guided (US-guided) femoral nerve block (FNB) in an acute hospital setting. Pilot prospective observational study. Orthopedic operating room of a regional trauma hospital. 15 anesthesiologists of various levels of experience in US-guided FNB (estimated minimum experience < 10 procedures; maximum about 50 procedures, and from basic trainees to consultants); and 15 patients (5 men and 10 women), aged 77 ± 15 (mean ± SD yrs) years. MEASUREMENTS/OBSERVATIONS: A data capture "tool", which was modified from one previously developed for ergonomic study of spinal anesthesia, was studied. Patient, operator, and heterogeneous environmental factors related to ergonomic performance of US-guided FNB were identified. The observation period started immediately before commencement of positioning the patient and ended on completion of perineural injection. Data were acquired using direct observations, photography, and application of a questionnaire. The quality of ergonomic performance was generally suboptimal and varied greatly among operators. Eight (experience < 10 procedures) of 15 operators excessively rotated their head, neck, and/or back to visualize the image on the ultrasound machine. Eight operators (experience < 10 procedures) performed the procedure with excessive thoracolumbar flexion. Performance of US-guided FNB presents ergonomic challenges and was suboptimal during most of the procedures observed. Formal training in US-guided peripheral nerve blockade should include reference to ergonomic factors. Copyright © 2011 Elsevier Inc. All rights reserved.

Feasibility of a novel remote daily monitoring system for age-related macular degeneration using mobile handheld devices: results of a pilot study.

PubMed

Kaiser, Peter K; Wang, Yi-Zhong; He, Yu-Guang; Weisberger, Annemarie; Wolf, Stephane; Smith, Craig H

2013-10-01

This pilot study evaluated the feasibility of the Health Management Tool (HMT), a novel computing system using mobile handheld devices, to remotely monitor retinal visual function daily in patients with neovascular age-related macular degeneration treated with ranibizumab. Patients with neovascular age-related macular degeneration in at least 1 eye (newly diagnosed or successfully treated < 1 year) and eligible for ranibizumab therapy were enrolled in this 16-week, prospective, open-label, single-arm study. Patients performed a shape discrimination hyperacuity test (myVisionTrack [mVT]) daily on the HMT device (iPhone 3GS) remotely and at all clinic visits. Data entered into HMT devices were collected in the HMT database, which also sent reminders for patients to take mVT. Among 160 patients from 24 U.S. centers enrolled in the study (103 [64%] ≥ 75 years of age), 84.7% on average complied with daily mVT testing and ≈ 98.9% complied with at least weekly mVT testing. The HMT database successfully uploaded more than 17,000 mVT assessment values and sent more than 9,000 reminders. Elderly patients with neovascular age-related macular degeneration were willing and able to comply with daily self-testing of retinal visual function using mobile handheld devices in this novel system of remote vision monitoring.

Pulse pressure variation-guided fluid therapy after cardiac surgery: a pilot before-and-after trial.

PubMed

Suzuki, Satoshi; Woinarski, Nicholas C Z; Lipcsey, Miklos; Candal, Cristina Lluch; Schneider, Antoine G; Glassford, Neil J; Eastwood, Glenn M; Bellomo, Rinaldo

2014-12-01

The aim of this study is to study the feasibility, safety, and physiological effects of pulse pressure variation (PPV)-guided fluid therapy in patients after cardiac surgery. We conducted a pilot prospective before-and-after study during mandatory ventilation after cardiac surgery in a tertiary intensive care unit. We introduced a protocol to deliver a fluid bolus for a PPV≥13% for at least >10 minutes during the intervention period. We studied 45 control patients and 53 intervention patients. During the intervention period, clinicians administered a fluid bolus on 79% of the defined PPV trigger episodes. Median total fluid intake was similar between 2 groups during mandatory ventilation (1297 mL [interquartile range 549-1968] vs 1481 mL [807-2563]; P=.17) and the first 24 hours (3046 mL [interquartile range 2317-3982] vs 3017 mL [2192-4028]; P=.73). After adjusting for several baseline factors, PPV-guided fluid management significantly increased fluid intake during mandatory ventilation (P=.004) but not during the first 24 hours (P=.47). Pulse pressure variation-guided fluid therapy, however, did not significantly affect hemodynamic, renal, and metabolic variables. No serious adverse events were noted. Pulse pressure variation-guided fluid management was feasible and safe during mandatory ventilation after cardiac surgery. However, its advantages may be clinically small. Copyright © 2014 Elsevier Inc. All rights reserved.

Coffee Enema for Preparation for Small Bowel Video Capsule Endoscopy: A Pilot Study

PubMed Central

Kim, Eun Sun; Keum, Bora; Seo, Yeon Seok; Jeen, Yoon Tae; Lee, Hong Sik; Um, Soon Ho; Kim, Chang Duck; Ryu, Ho Sang

2014-01-01

Coffee enemas are believed to cause dilatation of bile ducts and excretion of bile through the colon wall. Proponents of coffee enemas claim that the cafestol palmitate in coffee enhances the activity of glutathione S-transferase, an enzyme that stimulates bile excretion. During video capsule endoscopy (VCE), excreted bile is one of the causes of poor preparation of the small bowel. This study aimed to evaluate the feasibility and effect of coffee enema for preparation of the small bowel during VCE. In this pilot study, 17 of 34 patients were assigned to the coffee enema plus polyethylene glycol (PEG) 2 L ingestion group, whereas the 17 remaining control patients received 2 L of PEG only. The quality of bowel preparation was evaluated in the two patient groups. Bowel preparations in the proximal segments of small bowel were not differ between two groups. In the mid and distal segments of the small intestine, bowel preparations tend to be better in patients who received coffee enemas plus PEG than in patients who received PEG only. The coffee enema group did not experience any complications or side effects. Coffee enemas may be a feasible option, and there were no clinically significant adverse events related to coffee enemas. More prospective randomized studies are warranted to improve small bowel preparation for VCE. PMID:25136541

A pilot study using lactulose in management of minimal hepatic encephalopathy in children with extrahepatic portal vein obstruction.

PubMed

El-Karaksy, Hanaa Mostafa; Afifi, Omneya; Bakry, Azza; Kader, Ann Abdel; Saber, Noha

2017-02-01

Minimal hepatic encephalopathy (MHE) is not associated with overt neuropsychiatric symptoms but rather with subtle changes in psychometric and/or neurophysiologic tests. We aimed to diagnose MHE in children with extrahepatic portal vein obstruction (EHPVO) and to evaluate the effect of lactulose on MHE. A prospective study was carried out on 30 patients with EHPVO (21 males; mean age 10±2.5 years). The study was carried out in the Pediatric Hepatology Unit, Cairo University Pediatric Hospital, Cairo, Egypt, between 2011 and 2013. All patients were subjected to clinical and laboratory assessment, neuropsychmetric testing using the arabic version of Wechsler intelligence tests, neurophysiological testing by visual electroencephalogram and P300 event related potentials (ERP). The prevalence of MHE among children with EHPVO was 20% (6/30). After randomization to treatment and no-treatment groups using lactulose, all tests were repeated after three months. Among four patients with MHE who received lactulose, three (75%) improved. On the other hand, one of the patients in the no-treatment group developed MHE. Only one patient in the treatment arm had to discontinue lactulose because of severe diarrhea. This pilot study revealed that the prevalence of MHE was 20%. Improvement on psychometic tests was seen in 75% of our patients (3/4) after treatment with lactulose. Lactulose treatment was well tolerated.

Health professionals' reports of information given to parents following the prenatal diagnosis of sex chromosome anomalies and outcomes of pregnancies: a pilot study.

PubMed

Hall, Sue; Abramsky, Lenore; Marteau, Theresa M

2003-07-01

To examine the association between the information health professionals report providing parents about sex chromosome anomalies (SCAs) and the outcomes of affected pregnancies. Telephone interviews were conducted with health professionals who disclosed the prenatal diagnosis of an SCA to parents. The statements they reported providing to parents about the condition were coded as positive, neutral or negative. Outcomes of the pregnancies were obtained from medical records. Six of the 23 pregnancies were terminated. Health professionals reported giving parents of these six cases a greater amount of negative information about an SCA than did the health professionals reporting on the information given to the parents who continued with their pregnancies. Health professionals reported giving a similar amount of positive and neutral information to both groups of parents. The results of this pilot study suggest that there is a positive association between the amount of negative information parents are given initially about a sex chromosome anomaly and the decision to terminate the affected pregnancy. This study is limited by its small sample size and reliance on health professionals' self-reports of information provided to parents. Larger, prospective studies in which consultations are tape-recorded and linked to parents' subsequent decision making and adjustment are needed. Copyright 2003 John Wiley & Sons, Ltd.

Confocal laser endomicroscopy for in vivo diagnosis of Barrett's oesophagus and associated neoplasia: a pilot study conducted in a single Italian centre.

PubMed

Trovato, Cristina; Sonzogni, Angelica; Ravizza, Davide; Fiori, Giancarla; Tamayo, Darina; De Roberto, Giuseppe; de Leone, Annalisa; De Lisi, Stefania; Crosta, Cristiano

2013-05-01

Diagnosis and management of Barrett's oesophagus are controversial. Technical improvements in real-time recognition of intestinal metaplasia and neoplastic foci provide the chance for more effective target biopsies. Confocal laser endomicroscopy allows to analyze living cells during endoscopy. To assess the diagnostic accuracy, inter- and intra-observer variability of endomicroscopy for detecting in vivo neoplasia (dysplasia and/or early neoplasia) in Barrett's oesophagus. Prospective pilot study. Patients referred for known Barrett's oesophagus were screened. Endomicroscopy was carried out in a circular fashion, every 1-2 cm, on the whole columnar-lined distal oesophagus. Visible lesions, when present, were analyzed first. Targeted biopsies were taken. Confocal images were classified according to confocal Barrett classification. Endomicroscopic and histological findings were compared. Forty-eight out of 50 screened patients underwent endomicroscopy. Visible lesions were observed in 3 patients. In a per-biopsy analysis, Barrett's-oesophagus-associated neoplasia could be predicted with an accuracy of 98.1%. The agreement between endomicroscopic and histological results was substantial (κ=0.76). This study suggests that endomicroscopy can provide in vivo diagnosis of Barrett's oesophagus-associated neoplasia. Because it allows for the study of larger surface areas of the mucosa, endomicroscopy may lead to significant improvements in the in vivo screening and surveillance of Barrett's oesophagus. Copyright © 2013 Editrice Gastroenterologica Italiana S.r.l. Published by Elsevier Ltd. All rights reserved.

Statistical Application and Cost Saving in a Dental Survey

PubMed Central

Chyou, Po-Huang; Schroeder, Dixie; Schwei, Kelsey; Acharya, Amit

2017-01-01

Objective To effectively achieve a robust survey response rate in a timely manner, an alternative approach to survey distribution, informed by statistical modeling, was applied to efficiently and cost-effectively achieve the targeted rate of return. Design A prospective environmental scan surveying adoption of health information technology utilization within their practices was undertaken in a national pool of dental professionals (N=8000) using an alternative method of sampling. The piloted approach to rate of cohort sampling targeted a response rate of 400 completed surveys from among randomly targeted eligible providers who were contacted using replicated subsampling leveraging mailed surveys. Methods Two replicated subsample mailings (n=1000 surveys/mailings) were undertaken to project the true response rate and estimate the total number of surveys required to achieve the final target. Cost effectiveness and non-response bias analyses were performed. Results The final mailing required approximately 24% fewer mailings compared to targeting of the entire cohort, with a final survey capture exceeding the expected target. An estimated $5000 in cost savings was projected by applying the alternative approach. Non-response analyses found no evidence of bias relative to demographics, practice demographics, or topically-related survey questions. Conclusion The outcome of this pilot study suggests that this approach to survey studies will accomplish targeted enrollment in a cost effective manner. Future studies are needed to validate this approach in the context of other survey studies. PMID:28373286

Patient participation in cancer clinical trials: A pilot test of lay navigation.

PubMed

Cartmell, Kathleen B; Bonilha, Heather S; Matson, Terri; Bryant, Debbie C; Zapka, Jane G; Bentz, Tricia A; Ford, Marvella E; Hughes-Halbert, Chanita; Simpson, Kit N; Alberg, Anthony J

2016-08-15

Clinical trials (CT) represent an important treatment option for cancer patients. Unfortunately, patients face challenges to enrolling in CTs, such as logistical barriers, poor CT understanding and complex clinical regimens. Patient navigation is a strategy that may help to improve the delivery of CT education and support services. We examined the feasibility and initial effect of one navigation strategy, use of lay navigators. A lay CT navigation intervention was evaluated in a prospective cohort study among 40 lung and esophageal cancer patients. The intervention was delivered by a trained lay navigator who viewed a 17-minute CT educational video with each patient, assessed and answered their questions about CT participation and addressed reported barriers to care and trial participation. During this 12-month pilot project, 85% (95% CI: 72%-93%) of patients eligible for a therapeutic CT consented to participate in the CT navigation intervention. Among navigated patients, CT understanding improved between pre- and post-test (means 3.54 and 4.40, respectively; p-value 0.004), and 95% (95% CI: 82%-98%) of navigated patients consented to participate in a CT. Navigated patients reported being satisfied with patient navigation services and CT participation. In this formative single-arm pilot project, initial evidence was found for the potential effect of a lay navigation intervention on CT understanding and enrollment. A randomized controlled trial is needed to examine the efficacy of the intervention for improving CT education and enrollment.

Ultrasound-guided stellate ganglion blocks combined with pharmacological and occupational therapy in Complex Regional Pain Syndrome (CRPS): a pilot case series ad interim.

PubMed

Wei, Karin; Feldmann, Robert E; Brascher, Anne-Kathrin; Benrath, Justus

2014-12-01

This preliminary and retrospective pilot case series examines a treatment concept consisting of ultrasound-guided stellate ganglion blocks (SGBs) combined with pharmacological and occupational therapy in patients with complex regional pain syndrome (CRPS) of the hand. Efficacy of combined treatment concepts and safety of ultrasound-guided SGB have not been sufficiently investigated yet. A total number of 156 blocks were evaluated in 16 patients with CRPS in a retrospective analysis. All patients received pharmacotherapy and a standard regimen of occupational therapy offered simultaneously to the SGBs. Changes in both spontaneous and evoked pain levels were assessed by numerical pain rating score before and after the last blockade of a series. Side effects were documented. The overall mean pain reduction was 63.2% regarding spontaneous and 45.3% regarding evoked pain. Mild complications, such as hoarseness or dysphagia, occurred in 13.5% of the blocks (21 SGBs). Serious complications, such as plexus paresis or accidental puncture of vessels or other structures, did not occur. Time between symptom onset and start of treatment did not affect the extent of pain reduction. The combination of ultrasound-guided SGB and simultaneous pharmacological and occupational therapy showed encouraging treatment results under conditions of this pilot case series. Assessment of efficacy of this combined treatment concept and safety of ultrasound-guided SGB require further prospective clinical studies with larger number of participants. Wiley Periodicals, Inc.

Feasibility and Pilot Study of the Pediatric Anesthesia NeuroDevelopment Assessment (PANDA) Project

PubMed Central

Sun, Lena S.; Li, Guohua; DiMaggio, Charles J.; Byrne, Mary W.; Ing, Caleb; Miller, Tonya LK; Bellinger, David C.; Han, Sena; McGowan, Francis X.

2012-01-01

Background Animal studies have documented that exposure of the developing brain to commonly used anesthetic agents induce neurotoxicity and late abnormal neurobehavioral functions as adults. Results from clinical studies have all been performed using existing datasets, and produced inconsistent results. To provide more definitive evidence to address the clinical relevance of anesthetic neurotoxicity in children, an interdisciplinary team of investigators designed and developed the Pediatric Anesthesia NeuroDevelopment Assessment (PANDA) project. We present pilot study results in 28 sibling pairs recruited and tested at Columbia University Medical Center (CUMC) and Children’s Hospital of Boston (CHB) for the PANDA project. Methods The PANDA project uses an ambi-directional cohort design. We performed prospective neuropsychological assessment in 28 exposed-unexposed sibling pairs ages 6–11 years old. The exposed siblings were ASA 1 or 2 and had received a single episode of anesthesia for inguinal hernia repair prior to age 36 months and the unexposed siblings had no anesthesia before age 36 months. All sibling pairs were English speaking and were 36 weeks gestational age or greater. Each sibling pair underwent direct testing using WASI and NEPSY II, and the parents completed questionnaires related to behavior using CBCL and Conners’ rating. Data are presented as means ± SD. We conducted descriptive analyses of demographic data. We compared exposed and unexposed sibling groups on WASI and NEPSY II, and total and T-scores from CBCL and Conners’ as continuous data by paired t test between. A P< 0.05 was considered significant. Results Following IRB approval for the study at both CUMC and CHB, the full PANDA study protocol was implemented to perform a pilot feasibility study. Our success rate was 96.7% in obtaining detailed medical and anesthesia records in our historical cohort. Scores for verbal IQ (Exposed=106.1±16.3,Unexposed=109.2±17.9), performance IQ (Exposed=109.1±16.0, Unexposed=113.9±15.9) and full IQ (Exposed=108.2±14.0, Unexposed=112.8±16.8) were comparable between siblings. There were no differences between the two groups in T scores for any of the NEPSY II sub-domains, CBCL or Conners’. An abstraction protocol with web-based electronic data capture forms also was developed in conjunction with the International Center for Health Outcomes and Innovation Research (InCHOIR). Conclusions The pilot study provided useful information for feasibility to recruit the sample size and to obtain relevant clinical data. For the final study protocol, both the neuropsychological battery and the age range for testing were revised. Our results confirmed the feasibility of our study approach, and yielded pilot data from neuropsychological testing. PMID:23076226

[Psychophysiological selection: status and prospects].

PubMed

Gurovskiĭ, N N; Novikov, M A

1981-01-01

The major stages in the development of psychophysiological selection of cosmonauts in the USSR are discussed. The psychophysiological selection was originally based on the data of psychoneurological expertise of the flight personnel and achievements of aviation psychology in the USSR. This was followed by the development of psychophysiological research, using instrumentation and simulation flights. Further complication of flight programs and participation of non-pilot cosmonauts (engineers, scientists) necessitated detailed study of personality properties and application of personality tests. At the present stage in the development of psychophysiological selection great importance is attached to the biorhythmological selection and methods for studying man's capabilities to control his own emotional, behavioral and autonomic reactions as well as environmental parameters. The review also discusses in detail methods of group selection and problems of rational selection of space crews.

Effects of Bluetooth device electromagnetic field on hearing: pilot study.

PubMed

Balachandran, R; Prepageran, N; Prepagaran, N; Rahmat, O; Zulkiflee, A B; Hufaida, K S

2012-04-01

The Bluetooth wireless headset has been promoted as a 'hands-free' device with a low emission of electromagnetic radiation. To evaluate potential changes in hearing function as a consequence of using Bluetooth devices, by assessing changes in pure tone audiography and distortion production otoacoustic emissions. Prospective study. Thirty adult volunteers were exposed to a Bluetooth headset device (1) on 'standby' setting for 6 hours and (2) at full power for 10 minutes. Post-exposure hearing was evaluated using pure tone audiography and distortion production otoacoustic emission testing. There were no statistically significant changes in hearing, as measured above, following either exposure type. Exposure to the electromagnetic field emitted by a Bluetooth headset, as described above, did not decrease hearing thresholds or alter distortion product otoacoustic emissions.

Recording Adverse Events Following Joint Arthroplasty: Financial Implications and Validation of an Adverse Event Assessment Form.

PubMed

Lee, Matthew J; Mohamed, Khalid M S; Kelly, John C; Galbraith, John G; Street, John; Lenehan, Brian J

2017-09-01

In Ireland, funding of joint arthroplasty procedures has moved to a pay-by-results national tariff system. Typically, adverse clinical events are recorded via retrospective chart-abstraction methods by administrative staff. Missed or undocumented events not only affect the quality of patient care but also may unrealistically skew budgetary decisions that impact fiscal viability of the service. Accurate recording confers clinical benefits and financial transparency. The aim of this study was to compare a prospectively implemented adverse events form with the current national retrospective chart-abstraction method in terms of pay-by-results financial implications. An adverse events form adapted from a similar validated model was used to prospectively record complications in 51 patients undergoing total hip or knee arthroplasties. Results were compared with the same cohort using an existing data abstraction method. Both data sets were coded in accordance with current standards for case funding. Overall, 114 events were recorded during the study through prospective charting of adverse events, compared with 15 events documented by customary method (a significant discrepancy). Wound drainage (15.8%) was the most common complication, followed by anemia (7.9%), lower respiratory tract infections (7.9%), and cardiac events (7%). A total of €61,956 ($67,778) in missed funding was calculated as a result. This pilot study demonstrates the ability to improve capture of adverse events through use of a well-designed assessment form. Proper perioperative data handling is a critical aspect of financial subsidies, enabling optimal allocation of funds. Copyright © 2017 Elsevier Inc. All rights reserved.

Impact of ao-dake-humi, Japanese traditional bamboo foot stimulator, on lower urinary tract symptoms, constipation and hypersensitivity to cold: a single-arm prospective pilot study.

PubMed

Minagawa, Tomonori; Saitou, Tetsuichi; Suzuki, Toshiro; Domen, Takahisa; Yokoyama, Hitoshi; Ishikawa, Masakuni; Hirakata, Shiro; Nagai, Takashi; Nakazawa, Masaki; Ogawa, Teruyuki; Ishizuka, Osamu

2016-12-09

Ao-dake-humi is a traditional Japanese bamboo foot stimulator consisting of a half-pipe-shaped step made of bamboo used to stimulate the foot by stepping on it, and is commonly used to promote general health among the elderly in Japan. However, its efficacy has not been reported in the scientific literature. This study was performed to investigate the role of ao-dake-humi focusing on lower urinary tract symptoms (LUTS), constipation, and hypersensitivity to cold (HC). Participants with LUTS, constipation, or HC were enrolled in this study. Ao-dake-humi was used twice a day for 28 days. Before and 28 days after starting ao-dake-humi use, international prostate symptom score (IPSS), quality-of-life (QoL) score, and overactive bladder symptom score (OABSS) were measured to evaluate the efficacy of ao-dake-humi on LUTS. To evaluate the objective efficacy of ao-dake-humi on LUTS, a frequency-volume chart (FVC) was plotted in LUTS patients for 3 days. A visual analogue scale (VAS) was used to evaluate the efficacy of ao-dake-humi on constipation (VAS-constipation) and HC (VAS-HC) in the participants with constipation or HC. A total of 24 participants were enrolled in this study. Twenty-one participants had LUTS, 11 had constipation, and 17 participants had HC. IPSS, especially storage-subscore, QoL score and OABSS, decreased significantly after use of ao-dake-humi. The use of ao-dake-humi increased maximal bladder capacity, resulting in a significant decrease in urinary frequency as determined from the FVC. In accordance with the results of VAS-constipation and VAS-HC, both constipation and HC were significantly relieved after ao-dake-humi use. The results of this prospective pilot study indicated that ao-dake-humi is safe and has therapeutic efficacy in cases of LUTS, constipation and HC. The possibility of using ao-dake-humi as physical neuromodulation therapy was shown in the management of LUTS, constipation and HC. UMIN000019333 (UMIN-CTR, Registered October-15-2015) retrospectively registered.

Spinal Orthoses: The Crucial Role of Comfort on Compliance of Wearing - Monocentric Prospective Pilot Study of Randomized Cross-Over Design.

PubMed

Herget, G W; Patermann, S; Strohm, P C; Zwingmann, J; Eichelberger, P; Südkamp, N P; Hirschmüller, A

2017-01-01

PURPOSE OF THE STUDY Various spine disorders are regularly treated by orthoses, and success of treatment depends on wearing these devices. In this study we examined the compliance, wear comfort, subjective stabilization and side effects associated with spinal orthoses using an individualized questionnaire and the Compact Short Form-12 Health Survey (SF-12). MATERIAL AND METHODS In this prospective pilot study of randomized cross-over design, twelve healthy volunteers with a mean age of 31.2 years wore three different types of orthoses, each for one week: A hyperextension brace (HB), a custom-made semirigid orthosis (SO) and a custom-made rigid orthosis (RO). The daily duration of wearing the orthosis was defined as primary endpoint; contentment was measured using an individualized questionnaire and the standardized SF-12. RESULTS In the study population calculated probability of wearing the HB and RO was between 0.2 und 38.5% (95% confidence interval). No volunteer wore the SO orthosis for the predefined time. The SO and RO each displayed high subjective stabilization, while the RO was more often associated with side effects like skin pressure marks than the SO. The need for rework due to discomfort was mainly necessary with the RO. We observed no substantial differences in feeling compression and sweating. Noteworthy, eight of 12 subjects complained of uncomfortable sternal pressure due to the upper pad of the HB. The SF-12: scores ranged from 52.1 to 48.6 on the physical (PCS), and from 53.7 to 50.8 on the mental component score (MCS), demonstrating an influence on QoL. DISCUSSION AND CONCLUSIONS The design as well as the orthosis itself influence the compliance of wearing and exert a moderate negative, but acceptable impact on QoL. The SO appeared to correlate with the best overall compromise between comfort and subjective stabilization. Further investigations are necessary in patients with spinal diseases, for whom the effect of orthosis wearing may surpass the potential discomfort. Key words: thoracolumbar spine, orthoses, SF-12 - Quality of Life - QoL, comfort, compliance.

Very-low-calorie ketogenic diet with aminoacid supplement versus very low restricted-calorie diet for preserving muscle mass during weight loss: a pilot double-blind study.

PubMed

Merra, G; Miranda, R; Barrucco, S; Gualtieri, P; Mazza, M; Moriconi, E; Marchetti, M; Chang, T F M; De Lorenzo, A; Di Renzo, L

2016-07-01

Obesity plays a relevant pathophysiological role in the development of health problems, arising as result of complex interaction of genetic, nutritional and metabolic factors. We conducted a dietary intervention case-control randomized trial, to compare the effectiveness on body composition of two nutritional protocols: a very-low-carbohydrate ketogenic diet (VLCKD), integrated by an aminoacid supplement with whey protein, and very low restricted-calorie diet (VLCD). The clinical study was conducted with a randomized case-control in which twenty-five healthy subjects gave informed consent to participate in the interventional study and were evaluated for their health and nutritional status, by anthropometric, and body composition evaluation. The results of this pilot study show that a diet low in carbohydrates, associated with a decreased caloric intake, is effective in weight loss. After VLCKD, versus VLCD, no significant differences in body lean of the trunk, body lean distribution (android and gynoid), total body lean were observed (p > 0.05). After VLCKD, no increasing of sarcopenia frequency, according ASSMI, was observed. Many studies have shown the effectiveness of the ketogenic diet on weight loss; even if not know how to work effectively, as some researchers believe that the weight loss is due to reduced calorie intake, satiety could also be induced by the effect of the proteins, rather than the low-carbohydrates. Our pilot study showed that a VLCKD was highly effective in terms of body weight reduction without to induce lean body mass loss, preventing the risk of sarcopenia. Further clinical trials are needed on a larger population and long-term body weight maintenance and risk factors management effects of VLCKD. There is no doubt, however, that a proper dietary approach would impact significantly on the reduction of public expenditure costs, in view of prospective data on increasing the percentage of obese people in our nation.

A pilot-study of hypnotherapy as complementary treatment for pain in chronic pancreatitis.

PubMed

Juel, Jacob; Abrahamsen, Randi; Olesen, Søren S; Drewes, Asbjørn M

2018-05-10

BackgroundChronic pain is the hallmark symptom of chronic pancreatitis (CP). Its treatment is complicated, and often the patients have side-effects notwithstanding that pain is not ameliorated in many cases. Hypnotherapy has been shown to improve symptoms of irritable bowel syndrome including abdominal pain and, as such, may serve as a remedy to relive pain. The aim of this open-label pilot-study was to test the effect of hypnotherapy for pain in patients with CP. MethodsFour patients with CP and chronic abdominal pain were included and followed for four consecutive weeks. The primary efficacy parameter was pain relief. After 1 week of baseline patients received a 1-h session of hypnotherapy. This was repeated at day 15 and day 23 and supplemented by self-administered hypnotherapy. ResultsThree of four participants completed the trial and experienced short lasting pain reduction during the trial. The reported pain relief was in the range of 20%-39% compared to baseline. Hypnotherapy improved self-reported sleep, vitality, and social life. ConclusionsThe results suggest that hypnotherapy may reduce pain related to CP. Furthermore, no adverse effects were reported and the majority of participants completed the trial. Further prospective controlled trials are warranted to examine the potential of hypnotherapy.

White matter volume mediates the relationship between self-efficacy and mobility in older women

PubMed Central

Nagamatsu, Lindsay S.; Hsu, Chun Liang; Davis, Jennifer C.; Best, John R.; Liu-Ambrose, Teresa

2017-01-01

Background With our aging population, understanding determinants of healthy aging is a priority. One essential component of healthy aging is mobility. While self-efficacy can directly impact mobility in older adults, it is unknown what role brain health may play in this relationship. Methods We conducted a cross-sectional pilot analysis of community-dwelling women (n = 80, mean age = 69 years) to examine whether brain volume mediates the relationship between falls-related self-efficacy, as measured by the Activities-specific Balance Confidence (ABC) scale, and mobility, as measured by the Timed Up and Go (TUG) test. Age, depression, education, functional comorbidities, and Montreal Cognitive Assessment (MoCA) were included in the model as covariates. Results We report that total white matter volume, specifically, significantly mediates the relationship between self-efficacy and mobility, where higher self-efficacy was associated with greater white matter volume (r=0.28), which in turn, was associated with better mobility (r=−0.30). Conclusions Our pilot study extends our understanding of the psychosocial and neurological factors that contribute to mobility, and provides insight into effective strategies that may be used to improve functional independence among older adults. Future prospective and intervention studies are required to further elucidate the nature of the relationship between self-efficacy, mobility, and brain health. PMID:27749206

Subcutaneous Midazolam with and without Ketamine for Sedation In Children Undergoing Dental Treatment: A Pilot Study.

PubMed

Flores-Castillo, D; Martínez-Rider, R; Ruiz-Rodríguez, S; Garrocho-Rangel, A; Lara-Guevara, J; Pozos-Guillén, A

2015-01-01

The objective of this study was to evaluate the efficacy of subcutaneous (SC) sedation using midazolam with and without ketamine in non-cooperative pediatric patients undergoing dental treatment. A prospective, randomized, controlled, double-blind, crossover pilot clinical trial was carried out in 13 children, aged between 17-46 months, ASA l, Frankl 1. Two sedation schemes were administered SC: Midazolam alone (M), and a combination of Midazolam-Ketamine (MK). Both regimens were administered to the same patient in two consecutive treatment sessions, in accordance with a random assignment. Overall behavior, movement, and crying were assessed according to the modified Houpt scale. Heart rate, blood pressure, blood oxygen saturation, and possible side effects were also monitored. The percentage of non-crying children was always higher in the treatment with MK compared with the treatment with M, but without a significant statistical difference. Regarding variable body movement, the percentage of children without movement was higher in the MK group, although only up to minute 10; no significant differences were found at 20, 30, and 40 minutes, and from minute 40, body movement was lower in the M group. Midazolam alone and the midazolam-ketamine combination administered subcutaneously resulted in a safe and efficient pharmacological method for providing moderate sedation to non-cooperative pediatric patients undergoing dental treatment.

A new progestogen-only medical therapy for outpatient management of acute, abnormal uterine bleeding: a pilot study.

PubMed

Ammerman, Stacy R; Nelson, Anita L

2013-06-01

The objective of this investigation was to study short-term efficacy and feasibility of a new progestogen-only treatment for outpatient management of acute abnormal uterine bleeding. This was a prospective, single-arm, pilot clinical trial of a progestogen-only bridging treatment for acute abnormal uterine bleeding in nonpregnant, premenopausal women in the Gynecologic Urgent Care Clinic at Harbor-UCLA Medical Center. Subjects were administered a depo-medroxyprogesterone acetate 150 mg intramuscular injection and given medroxyprogesterone acetate 20 mg to be taken orally every 8 hours for 3 days. The primary outcome measures included a percentage of women who stopped bleeding in 5 days, time to bleeding cessation, reduction in numbers of pads used, side effects, and patient satisfaction. All 48 women stopped bleeding within 5 days; 4 women had spotting only at the time of their last contact during the 5 day follow-up. Mean time to bleeding cessation was 2.6 days. Side effects were infrequent and patient satisfaction was high. Injection of depo-medroxyprogesterone acetate 150 mg intramuscularly combined with 3 days of oral medroxyprogesterone acetate 20 mg every 8 hours for 9 doses is an effective outpatient therapy for acute abnormal uterine bleeding. Copyright © 2013 Mosby, Inc. All rights reserved.

Black blood MRI in suspected large artery primary angiitis of the central nervous system.

PubMed

Pfefferkorn, Thomas; Linn, Jennifer; Habs, Maximilian; Opherk, Christina; Cyran, Clemens; Ottomeyer, Caroline; Straube, Andreas; Dichgans, Martin; Nikolaou, Konstantin; Saam, Tobias

2013-07-01

Single case reports suggest that black blood MRI (T1-weighted fat and blood suppressed sequences with and without contrast injection; BB-MRI) may visualize intracranial vessel wall contrast enhancement (CE) in primary angiitis of the central nervous system (PACNS). In this single-center observational pilot study we prospectively investigated the value of BB-MRI in the diagnosis of large artery PACNS. Patients with suspected large artery PACNS received a standardized diagnostic program including BB-MRI. Vessel wall CE was graded (grade 0-2) by two experienced readers blinded to clinical data and correlated to the final diagnosis. Four of 12 included patients received a final diagnosis of PACNS. All of them showed moderate (grade 1) to strong (grade 2) vessel wall CE at the sites of stenosis. A moderate (grade 1) vessel wall CE grade was also observed in 6 of the remaining 8 patients in whom alternative diagnoses were made: arteriosclerotic disease (n = 4), intracranial dissection (n = 1), and Moyamoya disease (n = 1). Our pilot study demonstrates that vessel wall CE is a frequent finding in PACNS and its mimics. Larger trials will be necessary to evaluate the utility of BB-MRI in the diagnostic workup of PACNS. Copyright © 2012 by the American Society of Neuroimaging.

A prospective health impact assessment of the international astronomy and space exploration centre.

PubMed

Winters, L Y

2001-06-01

Assess the potential health impacts of the proposed International Astronomy and Space Exploration Centre on the population of New Wallasey. Contribute to the piloting of health impact assessment methods. Prospective health impact assessment involving brainstorming sessions and individual interviews with key informants and a literature review. New Wallasey Single Regeneration Budget 4 area. Key stakeholders including local residents' groups selected through purposeful snowball sampling. Recommendations are made that cover issues around: transport and traffic; civic design; security; public safety, employment and training. Health impact assessment is a useful pragmatic tool for facilitating wide consultation. In particular engaging the local population in the early planning stages of a proposed development, and assisting in highlighting changes to maximise the positive health influences on affected communities.

Long-term results of VBM and radiotherapy in advanced head and neck cancer

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

O'Conner, D.; Clifford, P.; Edwards, W.G.

1982-09-01

A report of a prospective pilot study is presented of 198 patients with advanced head and neck cancer, Stage III and IV, treated over 7 years with a combination of radical radiotherapy and a multidrug cytotoxic regimen, VBM (Vincristine, Bleomycin and Methotrexate) given synchronously during radiotherapy. All patients considered had disease classified as follows: T1 or T2 with clinically positive nodes (N+) and T3 or T4, irrespective of nodal status (N') were acceptable. Radiotherapy was divided into three equal sub-courses. The total dose aimed at was 60-66 Gy (1.8-2 Gy fractions daily).Usually three or four courses of VBM were given,more » one before the first sub-course of radiotherapy and the others immediately after each sub-course. The intervals allowed between each sub-course of radiation produced a median reduction over all patients of 4.5% in TDF (ret NSD) below the standard course of 30 x 20 Gy in 6 weeks. Survival and recurrence-free data were fully documented. The crude actuarial survival probability was 41% at 60 months (198 patients). The probability of remaining totally recurrence-free (disease-free deaths excluded) was 52% at 60 months. The presence of N+ disease affected adversely both survival and non-recurrence, 30% vs 61% and 46% vs 67%, respectively, at 30 months. Reduced survival was in part a result of an increased number of treatment-related deaths and metastases in N+ disease. Maintained local remission of disease above the clavicle was observed in 122/198 patients (62%). Salvage surgery was performed in 28/76 patients and 11 were rendered free of local disease during follow-up. This prospective pilot study shows results which are an improvement on our previous experience with radiotherapy and surgery alone and on the disease control generally reported.« less

Forewarning of hypotensive events using a Bayesian artificial neural network in neurocritical care.

PubMed

Donald, Rob; Howells, Tim; Piper, Ian; Enblad, P; Nilsson, P; Chambers, I; Gregson, B; Citerio, G; Kiening, K; Neumann, J; Ragauskas, A; Sahuquillo, J; Sinnott, R; Stell, A

2018-05-24

Traumatically brain injured (TBI) patients are at risk from secondary insults. Arterial hypotension, critically low blood pressure, is one of the most dangerous secondary insults and is related to poor outcome in patients. The overall aim of this study was to get proof of the concept that advanced statistical techniques (machine learning) are methods that are able to provide early warning of impending hypotensive events before they occur during neuro-critical care. A Bayesian artificial neural network (BANN) model predicting episodes of hypotension was developed using data from 104 patients selected from the BrainIT multi-center database. Arterial hypotension events were recorded and defined using the Edinburgh University Secondary Insult Grades (EUSIG) physiological adverse event scoring system. The BANN was trained on a random selection of 50% of the available patients (n = 52) and validated on the remaining cohort. A multi-center prospective pilot study (Phase 1, n = 30) was then conducted with the system running live in the clinical environment, followed by a second validation pilot study (Phase 2, n = 49). From these prospectively collected data, a final evaluation study was done on 69 of these patients with 10 patients excluded from the Phase 2 study because of insufficient or invalid data. Each data collection phase was a prospective non-interventional observational study conducted in a live clinical setting to test the data collection systems and the model performance. No prediction information was available to the clinical teams during a patient's stay in the ICU. The final cohort (n = 69), using a decision threshold of 0.4, and including false positive checks, gave a sensitivity of 39.3% (95% CI 32.9-46.1) and a specificity of 91.5% (95% CI 89.0-93.7). Using a decision threshold of 0.3, and false positive correction, gave a sensitivity of 46.6% (95% CI 40.1-53.2) and specificity of 85.6% (95% CI 82.3-88.8). With a decision threshold of 0.3, > 15 min warning of patient instability can be achieved. We have shown, using advanced machine learning techniques running in a live neuro-critical care environment, that it would be possible to give neurointensive teams early warning of potential hypotensive events before they emerge, allowing closer monitoring and earlier clinical assessment in an attempt to prevent the onset of hypotension. The multi-centre clinical infrastructure developed to support the clinical studies provides a solid base for further collaborative research on data quality, false positive correction and the display of early warning data in a clinical setting.

Introducing an enhanced recovery after surgery program in colorectal surgery: A single center experience

PubMed Central

Bona, Stefano; Molteni, Mattia; Rosati, Riccardo; Elmore, Ugo; Bagnoli, Pietro; Monzani, Roberta; Caravaca, Monica; Montorsi, Marco

2014-01-01

AIM: To study the implementation of an enhanced recovery after surgery (ERAS) program at a large University Hospital from “pilot study” to “standard of care”. METHODS: The study was designed as a prospective single centre cohort study. A prospective evaluation of compliance to a protocol based on full application of all ERAS principles, through the progressive steps of its implementation, was performed. Results achieved in the initial pilot study conducted by a dedicated team (n = 47) were compared to those achieved in the shared protocol phase (n = 143) three years later. Outcomes were length of postoperative hospital stay, readmission rate, compliance to the protocol and morbidity. Primary endpoint was the description of the results and the identification of critical issues of large scale implementation of an ERAS program in colorectal surgery emerged in the experience of a single center. Secondary endpoint was the identification of interventions that have been proven to be effective for facilitating the transition from traditional care pathways to a multimodal management protocol according to ERAS principles in colorectal surgery at a single center. RESULTS: During the initial pilot study (March 2009 to December 2010; 47 patients) conducted by a dedicated multidisciplinary team, compliance to the items of ERAS protocol was 93%, with a median length of hospital stay (LOS) of 3 d. Early anastomotic fistulas were observed in 2 cases (4.2%), which required reoperation (Clavien-Dindo grade IIIb). None of the patients had been discharged before the onset of the complication, which could therefore receive prompt treatment. There were also four (8.5%) minor complications (Clavien-Dindo grade II). Thirty days readmission rate was 4%. Perioperative mortality was nil. After implementation of the protocol throughout the Hospital in unselected patients (May 2012 to December 2012; 147 patients) compliance was 74%, with a median LOS of 6 d. Early anastomotic fistulas were observed in 11 cases (7.7%), 5 (3.5%) of which required reoperation (Clavien-Dindo grade IIIb). Two early anastomotic fistulas were treated by radiologic/endoscopic manoeuvres and 4 were treated conservatively. There were also 36 (25.2%) minor complications, 21 (14.7%) of which were Clavien-Dindo grade II and 15 (10.5%) of which were Clavien-Dindo grade I. Only two patients whose course was adversely affected by the development of an anastomotic leak had been discharged before the onset of the complication itself, requiring readmission. Readmission rate within 30 d was 4%. Perioperative mortality was 1%. CONCLUSION: Our results confirm that introduction of an ERAS protocol for colorectal surgery allows quicker postoperative recovery and shortens the length of stay compared to historical series. PMID:25516673

Resuscitation quality assurance for out-of-hospital cardiac arrest--setting-up an ambulance defibrillator telemetry network.

PubMed

Lyon, R M; Clarke, S; Gowens, P; Egan, G; Clegg, G R

2010-12-01

Out-of-hospital cardiac arrest (OHCA) is a leading cause of pre-hospital mortality. Chest compressions performed during cardiopulmonary resuscitation aim to provide adequate perfusion to the vital organs during cardiac arrest. Poor resuscitation technique and the quality of pre-hospital CPR influences outcome from OHCA. Transthoracic impedance (TTI) measurement is a useful tool in the assessment of the quality of pre-hospital resuscitation by ambulance crews but TTI telemetry has not yet been performed in the United Kingdom. We describe a pilot study to implement a data network to collect defibrillator TTI data via telemetry from ambulances. Prospective, observational pilot study over a 5-month period. Modems were fitted to 40 defibrillators on ambulances based in Edinburgh. TTI data was sent to a receiving computer after resuscitation attempts for OHCA. 58 TTI traces were transmitted during the pilot period. Compliance with the telemetry system was high. The mean ratio of chest compressions was 73% (95% CI 69-77%), the mean chest compression rate was 128 (95% CI 122-134). The mean time interval from chest compression interruption to shock delivery was 27 s (95% CI 22-32 s). Trans-thoracic impedance analysis is an effective means of recording important measures of resuscitation quality including the hands-on-the-chest time, compression rate and defibrillation interval time. TTI data transmission via telemetry is straightforward, efficient and allows resuscitation data to be captured and analysed from a large geographical area. Further research is warranted on the impact of post-resuscitation reporting on the quality of resuscitation delivered by ambulance crews. Copyright © 2010 Elsevier Ireland Ltd. All rights reserved.

Nonwoven-Based Gelatin/Polycaprolactone Membrane Proves Suitability in a Preclinical Assessment for Treatment of Soft Tissue Defects

PubMed Central

Schulz, Simon; Angarano, Marco; Fabritius, Martin; Mülhaupt, Rolf; Dard, Michel; Obrecht, Marcel; Tomakidi, Pascal

2014-01-01

Standard preclinical assessments in vitro often have limitations regarding their transferability to human beings, mainly evoked by their nonhuman and tissue-different/nontissue-specific source. Here, we aimed at employing tissue-authentic simple and complex interactive fibroblast-epithelial cell systems and their in vivo-relevant biomarkers for preclinical in vitro assessment of nonwoven-based gelatin/polycaprolactone membranes (NBMs) for treatment of soft tissue defects. NBMs were composed of electrospun gelatin and polycaprolactone nanofiber nonwovens. Scanning electron microscopy in conjunction with actin/focal contact integrin fluorescence revealed successful adhesion and proper morphogenesis of keratinocytes and fibroblasts, along with cells' derived extracellular matrix deposits. The “feel-good factor” of cells under study on the NBM was substantiated by forming a confluent connective tissue entity, which was concomitant with a stratified epithelial equivalent. Immunohistochemistry proved tissue authenticity over time by abundance of the biomarker vimentin in the connective tissue entity, and chronological increase of keratins KRT1/10 and involucrin expression in epithelial equivalents. Suitability of the novel NBM as wound dressing was evidenced by an almost completion of epithelial wound closure in a pilot mini-pig study, after a surgical intervention-caused gingival dehiscence. In summary, preclinical assessment by tissue-authentic cell systems and the animal pilot study revealed the NBM as an encouraging therapeutic medical device for prospective clinical applications. PMID:24494668

Scorecards and social accountability for improved maternal and newborn health services: A pilot in the Ashanti and Volta regions of Ghana.

PubMed

Blake, Carolyn; Annorbah-Sarpei, Nii Ankonu; Bailey, Claire; Ismaila, Yakubu; Deganus, Sylvia; Bosomprah, Samuel; Galli, Francesco; Clark, Sarah

2016-12-01

With the limited availability of quality emergency obstetric and newborn care (EmONC) in Ghana, and a lack of dialogue on the issue at district level, the Evidence for Action (E4A) program (2011-2015) initiated a pilot intervention using a social accountability approach in two regions of Ghana. Using scorecards to assess and improve maternal and newborn health services, the intervention study evaluated the effectiveness of engaging multiple, health and non-health sector stakeholders at district level to improve the enabling environment for quality EmONC. The quantitative study component comprised two rounds of assessments in 37 health facilities. The qualitative component is based on an independent prospective policy study. Results show a marked growth in a culture of accountability, with heightened levels of community participation, transparency, and improved clarity of lines of accountability among decision-makers. The breadth and type of quality of care improvements were dependent on the strength of community and government engagement in the process, especially in regard to more complex systemic changes. Engaging a broad network of stakeholders to support MNH services has great potential if implemented in ways that are context-appropriate and that build around full collaboration with government and civil society stakeholders. Copyright © 2016 International Federation of Gynecology and Obstetrics. Published by Elsevier Ireland Ltd. All rights reserved.

Clinical assessment of pitch perception.

PubMed

Vaerenberg, Bart; Pascu, Alexandru; Del Bo, Luca; Schauwers, Karen; De Ceulaer, Geert; Daemers, Kristin; Coene, Martine; Govaerts, Paul J

2011-07-01

The perception of pitch has recently gained attention. At present, clinical audiologic tests to assess this are hardly available. This article reports on the development of a clinical test using harmonic intonation (HI) and disharmonic intonation (DI). Prospective collection of normative data and pilot study in hearing-impaired subjects. Tertiary referral center. Normative data were collected from 90 normal-hearing subjects recruited from 3 different language backgrounds. The pilot study was conducted on 18 hearing-impaired individuals who were selected into 3 pathologic groups: high-frequency hearing loss (HF), low-frequency hearing loss (LF), and cochlear implant users (CI). Normative data collection and exploratory diagnostics by means of the newly constructed HI/DI tests using intonation patterns to find the just noticeable difference (JND) for pitch discrimination in low-frequency harmonic complex sounds presented in a same-different task. JND for pitch discrimination using HI/DI tests in the hearing population and pathologic groups. Normative data are presented in 5 parameter statistics and box-and-whisker plots showing median JNDs of 2 (HI) and 3 Hz (DI). The results on both tests are statistically abnormal in LF and CI subjects, whereas they are not significantly abnormal in the HF group. The HI and DI tests allow the clinical assessment of low-frequency pitch perception. The data obtained in this study define the normal zone for both tests. Preliminary results indicate possible abnormal TFS perception in some hearing-impaired subjects.

Brain abnormalities detected on magnetic resonance imaging of amphetamine users presenting to an emergency department: a pilot study.

PubMed

Fatovich, Daniel M; McCoubrie, David L; Song, Swithin J; Rosen, David M; Lawn, Nick D; Daly, Frank F

2010-09-06

To determine the prevalence of occult brain abnormalities in magnetic resonance imaging of active amphetamine users. Prospective convenience study in a tertiary hospital emergency department (ED). Patients presenting to the ED for an amphetamine-related reason were eligible for inclusion. We collected demographic data, drug use data, and performed a mini-mental state examination (MMSE). The proportion of patients with an abnormality on their MRI scan. Of 38 patients enrolled, 30 had MRI scans. Nineteen were male and their mean age was 26.7 +/- 5.4 years (range 19-41 years). The mean age of first amphetamine use was 18 years (range 13-26 years). Sixteen patients used crystal methamphetamine (mean amount 2.5 g/week), nine used amphetamine ("speed") (mean amount 2.9 g/week), and 23 used ecstasy (mean amount 2.3 tablets/week). Marijuana was smoked by 26 (mean amount 5.9 g/week), and 28 drank alcohol (mean amount 207 g/week). The median MMSE score was 27/30 (interquartile range, 26-29). Abnormalities on brain MRI scans were identified in six patients, most commonly an unidentified bright object (n = 4). In this pilot study of brain MRI of young people attending the ED with an amphetamine-related presentation, one in five had an occult brain lesion. While the significance of this is uncertain, it is congruent with evidence that amphetamines cause brain injury.

White Matter Volume Mediates the Relationship Between Self-Efficacy and Mobility in Older Women.

PubMed

Nagamatsu, Lindsay S; Hsu, Chun Liang; Davis, Jennifer C; Best, John R; Liu-Ambrose, Teresa

2016-01-01

Background/Study Context: With our aging population, understanding determinants of healthy aging is a priority. One essential component of healthy aging is mobility. Although self-efficacy can directly impact mobility in older adults, it is unknown what role brain health may play in this relationship. The authors conducted a cross-sectional pilot analysis of community-dwelling women (N = 80, mean age = 69 years) to examine whether brain volume mediates the relationship between falls-related self-efficacy, as measured by the Activities-specific Balance Confidence (ABC) scale, and mobility, as measured by the Timed Up and Go (TUG) test. Age, depression, education, functional comorbidities, and Montreal Cognitive Assessment (MoCA) were included in the model as covariates. The authors report that total white matter volume, specifically, significantly mediates the relationship between self-efficacy and mobility, where higher self-efficacy was associated with greater white matter volume (r = .28), which, in turn, was associated with better mobility (r = -.30). This pilot study extends our understanding of the psychosocial and neurological factors that contribute to mobility and provides insight into effective strategies that may be used to improve functional independence among older adults. Future prospective and intervention studies are required to further elucidate the nature of the relationship between self-efficacy, mobility, and brain health.

Development and pilot-testing of the Alopecia Areata Assessment Tool (ALTO).

PubMed

Li, David G; Huang, Kathie P; Xia, Fan Di; Joyce, Cara; Scott, Deborah A; Qureshi, Abrar A; Mostaghimi, Arash

2018-01-01

Alopecia areata (AA) is an autoimmune disease characterized by non-scarring hair loss. The lack of a definitive biomarker or formal diagnostic criteria for AA limits our ability to define the epidemiology of the disease. In this study, we developed and tested the Alopecia Areata Assessment Tool (ALTO) in an academic medical center to validate the ability of this questionnaire in identifying AA cases. The ALTO is a novel, self-administered questionnaire consisting of 8 closed-ended questions derived by the Delphi method. This prospective pilot study was administered during a 1-year period in outpatient dermatology clinics. Eligible patients (18 years or older with chief concern of hair loss) were recruited consecutively. No patients declined to participate. The patient's hair loss diagnosis was determined by a board-certified dermatologist. Nine scoring algorithms were created and used to evaluate the accuracy of the ALTO in identifying AA. 239 patients (59 AA cases and 180 non-AA cases) completed the ALTO and were included for analysis. Algorithm 5 demonstrated the highest sensitivity (89.8%) while algorithm 3 demonstrated the highest specificity (97.8%). Select questions were also effective in clarifying disease phenotype. In this study. we have successfully demonstrated that ALTO is a simple tool capable of discriminating AA from other types of hair loss. The ALTO may be useful to identify individuals with AA within large populations.

Climatotherapy in Japan: a pilot study

NASA Astrophysics Data System (ADS)

Kanayama, Hitomi; Kusaka, Yukinori; Hirai, Takayoshi; Inoue, Hiroyuki; Agishi, Yuko; Schuh, Angela

2017-12-01

Twenty-nine urban inhabitants participated in a half-day climatotherapy programme at the moderate mountain area and lowland area in the northwest part of the main island of Japan. The current study was aimed to investigate physically and mentally the objective and subjective influence of our short programme, which was a prospective pilot study of single intervention. Blood pressure was significantly descended during terrain cure at the uphill mountain path and returned after fresh-air rest cure, while there was no significant change throughout the programme at lowland flat path. Heart rate was significantly ascended and descended at both area, and more clearly changed at the mountain path. Profile of Mood Status brief form Japanese version administered before and after our half-day programme. Age adjusted T score of negative subscales, `tension-anxiety', `depression', `anger-hostility', `fatigue' and `confusion' were significantly lower after climatotherapy at both sites. Whereas, there was no significant change concerning `vigour' score. This short-version climatotherapy programme has been designed for people without enough time for long stay at health resort. It turned out our half-day climatotherapy programme contribute to mood status improvement. In addition, repeated practice of our short-version programme including endurance exercise with cool body shell using uphill path can be expected that blood pressure will go toward the normal range and heart rate will decrease both in usual time and during exercise. Therefore, health benefits can be expected of this climatotherapy programme.

Pilot Evaluation of a Palliative and End-of-Life Communication Intervention for Parents of Children With a Brain Tumor.

PubMed

Hendricks-Ferguson, Verna L; Pradhan, Kamnesh; Shih, Chie-Schin; Gauvain, Karen M; Kane, Javier R; Liu, Jingxia; Haase, Joan E

Providing timely palliative and end-of-life care (PC/EOL) information to parents of children with a serious illness is a national health care priority. The goals of this study were to determine feasibility, acceptability, and parent responses related to a PC/EOL communication intervention, titled "Communication Plan: Early through End of Life (COMPLETE)" to parents of children with a brain tumor. The study was a 2-site prospective, single-group pilot study targeting parents' stress and coping outcomes. The sample included 13 parents of 11 children (ie, 11 families). During the first 6 months postdiagnosis, we evaluated parent outcomes at 4 time points (baseline and 3 post-sessions). Our findings included significant decline in decision regret ( P = .0089); strong, significantly increased hope ( P ≤ .0001); and significantly decreased uncertainty ( P = .04). Over time, more than half of the parents (61.5%) preferred to receive information about their child's current condition and PC/EOL options. Our findings provide evidence to suggest that the COMPLETE intervention is feasible and acceptable and produces promising effects on 3 parent outcomes (ie, decision regret, hope, and uncertainty) in parents of children with a brain tumor. Further research is indicated to evaluate COMPLETE with a larger sample of parents of children with cancer and with a control group.

A prospective pilot study measuring muscle volumetric change in amyotrophic lateral sclerosis.

PubMed

Jenkins, Thomas M; Burness, Christine; Connolly, Daniel J; Rao, D Ganesh; Hoggard, Nigel; Mawson, Susan; McDermott, Christopher J; Wilkinson, Iain D; Shaw, Pamela J

2013-09-01

Our objective was to investigate the potential of muscle volume, measured with magnetic resonance (MR), as a biomarker to quantify disease progression in patients with amyotrophic lateral sclerosis (ALS). In this longitudinal pilot study, we first sought to determine the stability of volumetric muscle MR measurements in 11 control subjects at two time-points. We assessed feasibility of detecting atrophy in four patients with ALS, followed at three-month intervals for 12 months. Muscle power and MR volume were measured in thenar eminence (TEm), first dorsal interosseous (1DIO), tibialis anterior (TA) and tongue. Changes over time were assessed using linear regression models and t-tests. Results demonstrated that, in controls, no volumetric MR changes were seen (mean volume variation in all muscles < 5%, p > 0.1). In patients, between-subject heterogeneity was identified. Trends for volume loss were found in TEm (mean, - 26.84%, p = 0.056) and TA (- 8.29%, p = 0.077), but not in 1DIO (- 18.47%, p = 0.121) or tongue (< 5%, p = 0.367). In conclusion, volumetric muscle MR appears a stable measure in controls, and progressive volume loss was demonstrable in individuals with ALS in whom clinical weakness progressed. In this small study, subclinical atrophy was not demonstrable using muscle MR. Clinico-radiological discordance between muscle weakness and MR atrophy could reflect a contribution of upper motor neuron pathology.

A pilot study with very low-intensity, intermediate-frequency electric fields in patients with locally advanced and/or metastatic solid tumors.

PubMed

Salzberg, Marc; Kirson, Eilon; Palti, Yoram; Rochlitz, Christoph

2008-07-01

The transmission of electric fields using insulated electrodes has demonstrated that very low-intensity, properly tuned, intermediate-frequency electric fields, termed tumor-treating fields (TTFields), selectively stunts tumor cell growth and is accompanied by a decrease in tumor angiogenesis. This open, prospective pilot study was designed to evaluate the safety, tolerability, and efficacy profile of TTFields treatment in patients with locally advanced and/or metastatic solid tumors using the NovoTTF100A(TM) device. All 6 patients were heavily pre-treated with several lines of therapy; no additional standard treatment option was available to them. TTFields treatment using continuous NovoTTF-100A lasted a minimum of 14 days and was very well tolerated. No related serious adverse events occurred. Outcomes showed 1 partial response of a treated skin metastasis from a primary breast cancer, 3 cases where tumor growth was arrested during treatment, and 1 case of disease progression. One mesothelioma patient experienced lesion regression near TTFields with simultaneous tumor stability or progression in distal areas. Although the number of patients in this study is small, the lack of therapy toxicity and the efficacy observed in data gathered to date indicate the potential of TTFields as a new treatment modality for solid tumors, definitely warranting further investigation. (c) 2008 S. Karger AG, Basel

Clinical Validation of Therapeutic Drug Monitoring of Imipenem in Spent Effluent in Critically Ill Patients Receiving Continuous Renal Replacement Therapy: A Pilot Study

PubMed Central

Wen, Aiping; Li, Zhe; Yu, Junxian; Li, Ren; Cheng, Sheng; Duan, Meili; Bai, Jing

2016-01-01

Objectives The primary objective of this pilot study was to investigate whether the therapeutic drug monitoring of imipenem could be performed with spent effluent instead of blood sampling collected from critically ill patients under continuous renal replacement therapy. Methods A prospective open-label study was conducted in a real clinical setting. Both blood and effluent samples were collected pairwise before imipenem administration and 0.5, 1, 1.5, 2, 3, 4, 6, and 8 h after imipenem administration. Plasma and effluent imipenem concentrations were determined by reversed-phase high-performance liquid chromatography with ultraviolet detection. Pharmacokinetic and pharmacodynamic parameters of blood and effluent samples were calculated. Results Eighty-three paired plasma and effluent samples were obtained from 10 patients. The Pearson correlation coefficient of the imipenem concentrations in plasma and effluent was 0.950 (P<0.0001). The average plasma-to-effluent imipenem concentration ratio was 1.044 (95% confidence interval, 0.975 to 1.114) with Bland-Altman analysis. No statistically significant difference was found in the pharmacokinetic and pharmacodynamic parameters tested in paired plasma and effluent samples with Wilcoxon test. Conclusion Spent effluent of continuous renal replacement therapy could be used for therapeutic drug monitoring of imipenem instead of blood sampling in critically ill patients. PMID:27093294

HOME-BASED SELF-DELIVERED MIRROR THERAPY FOR PHANTOM PAIN: A PILOT STUDY*

PubMed Central

Darnall, Beth D.; Li, Hong

2014-01-01

Objective To test the feasibility and preliminary efficacy of self-delivered home-based mirror therapy for phantom pain. Design Uncontrolled prospective treatment outcome pilot study. Participants Forty community-dwelling adults with unilateral amputation and phantom pain >3 on a 0–10 numeric rating scale enrolled either during a one-time study visit (n = 30) or remotely (n = 10). Methods Participants received an explanation of mirror therapy and were asked to self-treat for 25 min daily. Participants completed and posted back sets of outcomes questionnaires at months 1 and 2 post-treatment. Main outcome was mean phantom pain intensity at post-treatment. Results A significant reduction in mean phantom pain intensity was found at month 1 (n = 31, p = 0.0002) and at month 2 (n = 26, p = 0.002). The overall median percentage reduction at month 2 was 15.4%. Subjects with high education (>16 years) compared with low education (<16 years) (37.5% vs 4.1%) had greater reduction in pain intensity (p = 0.01). Conclusion These findings support the feasibility and efficacy of home-based self-delivered mirror therapy; this low-cost treatment may defray medical costs, therapy visits, and the patient travel burden for people with motivation and a high level of education. More research is needed to determine methods of cost-effective support for people with lower levels of education. PMID:22378591

Efficacy of Atopy Patch Testing in Directed Dietary Therapy of Eosinophilic Esophagitis: A Pilot Study.

PubMed

Eckmann, Jason D; Ravi, Karthik; Katzka, David A; Davis, Dawn R; See, Jacalyn A; Geno, Debra R; Kryzer, Lori A; Alexander, Jeffrey A

2018-03-01

Atopy patch testing (APT) has shown potential for predicting dietary food triggers in studies of children and adolescents with eosinophilic esophagitis (EoE). To assess the efficacy of APT in adults with EoE. We conducted a prospective open-label pilot study of patients ≥ 18 years old with diagnosis of EoE at Mayo Clinic in Rochester, Minnesota, from November 2014 to January 2016. All patients underwent patch testing using intact food products, followed by a six food elimination diet and stepwise food reintroduction. Response to elimination diet was assessed with serial endoscopy with biopsies as well as clinical symptoms. APT results were directly compared to elimination diet results for assessment of efficacy. Correlation between clinical symptoms, endoscopic score, and histology was also qualitatively evaluated. Fifty percent of the patients had a positive APT, while only 16% had an APT result confirmed histologically during food reintroduction. Sensitivity of APT was calculated to be 5.9%, with specificity of 92.0%. Furthermore, we found significant qualitative inter-patient heterogeneity in the correlation between clinical symptoms, EREFS score, and histology. APT does not reliably predict food triggers identified by food elimination diet in adult patients with EoE. As a result, APT does not have a clear role in the evaluation of patients with EoE.

Factors affecting planned return to work after trauma: A prospective descriptive qualitative and quantitative study.

PubMed

Folkard, S S; Bloomfield, T D; Page, P R J; Wilson, D; Ricketts, D M; Rogers, B A

2016-12-01

The use of patient reported outcome measures (PROMs) in trauma is limited. The aim of this pilot study is to evaluate qualitative responses and factors affecting planned return to work following significant trauma, for which there is currently a poor evidence base. National ethical approval was obtained for routine prospective PROMs data collection, including EQ-5D, between Sept 2013 and March 2015 for trauma patients admitted to the Sussex Major Trauma Centre (n=92). 84 trauma patients disclosed their intended return to work at discharge. Additional open questions asked 'things done well' and 'things to be improved'. EQ-5D responses were valued using the time trade-off method. Statistical analysis between multiple variables was completed by ANOVA, and with categorical categories by Chi squared analysis. Only 18/68 of patients working at admission anticipated returning to work within 14days post-discharge. The injury severity scores (ISS) of those predicting return to work within two weeks and those predicting return to work longer than two weeks were 14.17 and 13.59, respectively. Increased physicality of work showed a trend towards poorer return to work outcomes, although non-significant in Chi-squared test in groups predicting return in less than or greater than two weeks (4.621, p=0.2017ns). No significant difference was demonstrated in the comparative incomes of patients with different estimated return to work outcomes (ANOVA r 2 =0.001, P=0.9590ns). EQ-5D scores were higher in those predicting return to work within two weeks when compared to greater than two weeks. Qualitative thematic content analysis of open responses was possible for 66/92 of respondents. Prominent positive themes were: care, staff, professionalism, and communication. Prominent negative themes were: food, ward response time, and communication. This pilot study highlights the importance of qualitative PROMs analysis in leading patient-driven improvements in trauma care. We provide standard deviations for ISS scores and EQ-5D scores in our general trauma cohort, for use in sample size calculations for further studies analysing factors affecting return to work after trauma. Crown Copyright © 2016. Published by Elsevier Ltd. All rights reserved.

Gender-Specific Combination HIV Prevention for Youth in High-Burden Settings: The MP3 Youth Observational Pilot Study Protocol

PubMed Central

Agot, Kawango

2017-01-01

Background Nearly three decades into the epidemic, sub-Saharan Africa (SSA) remains the region most heavily affected by human immunodeficiency virus (HIV), with nearly 70% of the 34 million people living with HIV globally residing in the region. In SSA, female and male youth (15 to 24 years) are at a disproportionately high risk of HIV infection compared to adults. As such, there is a need to target HIV prevention strategies to youth and to tailor them to a gender-specific context. This protocol describes the process for the multi-staged approach in the design of the MP3 Youth pilot study, a gender-specific, combination, HIV prevention intervention for youth in Kenya. Objective The objective of this multi-method protocol is to outline a rigorous and replicable methodology for a gender-specific combination HIV prevention pilot study for youth in high-burden settings, illustrating the triangulated methods undertaken to ensure that age, sex, and context are integral in the design of the intervention. Methods The mixed-methods, cross-sectional, longitudinal cohort pilot study protocol was developed by first conducting a systematic review of the literature, which shaped focus group discussions around prevention package and delivery options, and that also informed age- and sex- stratified mathematical modeling. The review, qualitative data, and mathematical modeling created a triangulated evidence base of interventions to be included in the pilot study protocol. To design the pilot study protocol, we convened an expert panel to select HIV prevention interventions effective for youth in SSA, which will be offered in a mobile health setting. The goal of the pilot study implementation and evaluation is to apply lessons learned to more effective HIV prevention evidence and programming. Results The combination HIV prevention package in this protocol includes (1) offering HIV testing and counseling for all youth; (2) voluntary medical circumcision and condoms for males; (3) pre-exposure prophylaxis (PrEP), conditional cash transfer (CCT), and contraceptives for females; and (4) referrals for HIV care among those identified as HIV-positive. The combination package platform selected is mobile health teams in an integrated services delivery model. A cross-sectional analysis will be conducted to determine the uptake of the interventions. To determine long-term impact, the protocol outlines enrolling selected participants in mutually exclusive longitudinal cohorts (HIV-positive, PrEP, CCT, and HIV-negative) followed by using mobile phone text messages (short message service, SMS) and in-person surveys to prospectively assess prevention method uptake, adherence, and risk compensation behaviors. Cross-sectional and sub-cohort analyses will be conducted to determine intervention packages uptake. Conclusions The literature review, focus groups, and modeling indicate that offering age- and gender- specific combination HIV prevention interventions that include biomedical, behavioral, and structural interventions can have an impact on HIV risk reduction. Implementing this protocol will show the feasibility of delivering these services at scale. The MP3 Youth study is one of the few combination HIV prevention intervention protocols incorporating youth- and gender-specific interventions in one delivery setting. Lessons learned from the design of the protocol can be incorporated into the national guidance for combination HIV prevention for youth in Kenya and other high-burden SSA settings. Trial Registration ClinicalTrials.gov NCT01571128; http://clinicaltrials.gov/ct2/show/NCT01571128?term=MP3+youth&rank=1 (Archived by WebCite at http://www.webcitation.org/6nmioPd54) PMID:28274904

Combating information overload: a six-month pilot evaluation of a knowledge management system in general practice.

PubMed Central

O'Brien, C; Cambouropoulos, P

2000-01-01

A six-month prospective study was conducted on the usefulness and usability of a representative electronic knowledge management tool, the WAX Active Library, for 19 general practitioners (GPs) evaluated using questionnaires and audit trail data. The number of pages accessed was highest in the final two months, when over half of the access trails were completed within 40 seconds. Most GPs rated the system as easy to learn, fast to use, and preferable to paper for providing information during consultations. Such tools could provide a medium for the activities of knowledge officers, help demand management, and promote sharing of information within primary care groups and across NHSnet or the Internet. PMID:10962792

A prospective clinical pilot-trial comparing the effect of an optimized mixed diet versus a flexible low-glycemic index diet on nutrient intake and HbA(1c) levels in children with type 1 diabetes.

PubMed

Marquard, Jan; Stahl, Anna; Lerch, Christian; Wolters, Mareen; Grotzke-Leweling, Maike; Mayatepek, Ertan; Meissner, Thomas

2011-01-01

Low-glycemic index (GI) diet vs. high-GI diet improves glycemic control, but it is not clear whether a low-GI diet is superior to an optimized mixed diet (OMD). This was a 12-week parallel-group pilot-trial including 17 children with type 1 diabetes. A separate dietary education into the allocated diet (OMD vs. low-GI) was performed. Nutrition was recorded by means of a three-day dietary record. The primary objective was to determine the macro- and micronutrient composition of the different diets, the secondary objective was to determine the short-term effect on HbA(1c) levels. In the low-GI group carbohydrate intake decreased, fat intake increased by trend. In the OMD group fat and energy intake decreased. No changes of HbA(1c) levels between the groups were observed. OMD could have positive effects in overweight and obese diabetic children, since a reduction in fat and energy intake can be achieved. The findings of this pilot-trial suggest that OMD could be superior to a low-GI diet.

Metal elements in tissue with dental peri-implantitis: a pilot study.

PubMed

Fretwurst, Tobias; Buzanich, Guenter; Nahles, Susanne; Woelber, Johan Peter; Riesemeier, Heinrich; Nelson, Katja

2016-09-01

Dental peri-implantitis is characterized by a multifactorial etiology. The role of metal elements as an etiological factor for peri-implantitis is still unclear. The aim of this study was to investigate the incidence of metal elements in bone and mucosal tissues around dental Grade 4 CP titanium implants with signs of peri-implantitis in human patients. In this prospective pilot study, all patients were enrolled consecutively in two study centers. Bone and soft tissue samples of patients with peri-implantitis with indication for explantation were analyzed for the incidence of different elements (Ca, P, Ti, Fe) by means of synchrotron radiation X-ray fluorescence spectroscopy (SRXRF) and polarized light microscopy (PLM). The existence of macrophages and lymphocytes in the histologic specimens was analyzed. Biopsies of 12 patients (seven bone samples, five mucosal samples) were included and analyzed. In nine of the 12 samples (75%), the SRXRF examination revealed the existence of titanium (Ti) and an associated occurrence with Iron (Fe). Metal particles were detected in peri-implant soft tissue using PLM. In samples with increased titanium concentration, lymphocytes were detected, whereas M1 macrophages were predominantly seen in samples with metal particles. Titanium and Iron elements were found in soft and hard tissue biopsies retrieved from peri-implantitis sites. Further histologic and immunohistochemical studies need to clarify which specific immune reaction metal elements/particles induce in dental peri-implant tissue. © 2015 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

Prognostic value of the reactive oxygen species in severe sepsis and septic shock patients: a pilot study.

PubMed

Montini, Luca; DE Sole, Pasquale; Pennisi, Mariano A; Rossi, Cristina; Scatena, Roberto; DE Pascale, Gennaro; Bello, Giuseppe; Cutuli, Salvatore L; Antonelli, Massimo

2016-12-01

Reactive oxygen species (ROS) have been shown to play a role in the pathophysiology of sepsis. The aim of this study was to investigate ROS production over time in critically ill with sepsis patients and its correlation with outcome. This was a pilot single-centre prospective, observational study of patients consecutively admitted to our 18-general ICU. Over a period of 6 months all the consecutive patients with recent-onset of severe sepsis or septic shock were enrolled. Clinical and demographic characteristics of all patients were recorded. ROMs (ROS metabolites), reduced sulfhydryl groups (SH) and plasmatic lactate levels were collected at enrollment in the study and then every 5-7 days over 28 days or until sepsis resolution or death during sepsis. ROMs were analysed spectrophotometrically by the d-ROMs test (Diacron-Italia). SH were assayed in plasma by Ellman's reaction by spectrophotometric method. Septic shock-related mortality was defined as death that occurred during the follow up period, when the signs of shock remained, and death could not be attributed to causes other than septic shock by the attending physician. Twenty-five patients were studied. The SOFA score and the plasmatic lactate levels significantly correlated with the ROMs plasmatic levels. The mortality rate was higher in patients whose ROMs plasmatic levels decreased during septic shock evolution. Serial measurements of the ROMs plasmatic levels together with the SOFA score and lactate levels could help to identify septic shock patients with a very high probability of death.

Remote Ambulatory Management of Veterans with Obstructive Sleep Apnea

PubMed Central

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

2016-01-01

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

Efficacy of chess training for the treatment of ADHD: A prospective, open label study.

PubMed

Blasco-Fontecilla, Hilario; Gonzalez-Perez, Marisa; Garcia-Lopez, Raquel; Poza-Cano, Belen; Perez-Moreno, Maria Rosario; de Leon-Martinez, Victoria; Otero-Perez, Jose

2016-01-01

To examine the effectiveness of playing chess as a treatment option for children with ADHD. Parents of 44 children ages 6 to 17 with a primary diagnosis of ADHD consented to take part in the study. Parents completed the Spanish version of the Swanson, Nolan and Pelham Scale for parents (SNAP-IV) and the Abbreviated Conner's Rating Scales for parents (CPRS-HI) prior to an 11-week chess-training program. We used a paired t-test to compare pre- and post-intervention outcomes, and Cohen-d calculations to measure the magnitude of the effect. The statistical significance was set at P<.05. Children with ADHD improved in both the SNAP-IV (t=6.23; degrees of freedom (df)=41; P<.001) and the CPRS-HI (t=5.39; df=33; P<.001). Our results suggest a large effect in decreasing the severity of ADHD as measured by the SNAP-IV (d=0.85) and the CPRS-HI (d=0.85). Furthermore, we found a correlation between intelligence quotient and SNAP-IV improvement (P<.05). The results of our pilot study should be interpreted with caution. This pilot project highlights the importance of carrying out larger studies with a case-control design. If our results are replicated in better designed studies, playing chess could be included within the multimodal treatment of ADHD. Copyright © 2014 SEP y SEPB. Published by Elsevier España. All rights reserved.

Computerization of Mental Health Integration Complexity Scores at Intermountain Healthcare

PubMed Central

Oniki, Thomas A.; Rodrigues, Drayton; Rahman, Noman; Patur, Saritha; Briot, Pascal; Taylor, David P.; Wilcox, Adam B.; Reiss-Brennan, Brenda; Cannon, Wayne H.

2014-01-01

Intermountain Healthcare’s Mental Health Integration (MHI) Care Process Model (CPM) contains formal scoring criteria for assessing a patient’s mental health complexity as “mild,” “medium,” or “high” based on patient data. The complexity score attempts to assist Primary Care Physicians in assessing the mental health needs of their patients and what resources will need to be brought to bear. We describe an effort to computerize the scoring. Informatics and MHI personnel collaboratively and iteratively refined the criteria to make them adequately explicit and reflective of MHI objectives. When tested on retrospective data of 540 patients, the clinician agreed with the computer’s conclusion in 52.8% of the cases (285/540). We considered the analysis sufficiently successful to begin piloting the computerized score in prospective clinical care. So far in the pilot, clinicians have agreed with the computer in 70.6% of the cases (24/34). PMID:25954401

Navigator® and SmartPilot® View are helpful in guiding anesthesia and reducing anesthetic drug dosing.

PubMed

Cirillo, V; Zito Marinosci, G; De Robertis, E; Iacono, C; Romano, G M; Desantis, O; Piazza, O; Servillo, G; Tufano, R

2015-11-01

The recently introduced Navigator® (GE Healthcare, Helsinki, Finland) and SmartPilot® View (Dräger Medical, Lübeck, Germany) show the concentrations and predicted effects of combined anesthetic drugs, and should facilitate more precisely their titration. Our aim was to evaluate if Navigator® or SmartPilot® View guided anesthesia was associated with a good quality of analgesia, depth of hypnosis and may reduce anesthetic requirements. We performed a prospective non-randomized study. Sixty ASA I-II patients undergoing balanced general anesthesia for abdominal and plastic surgery were enrolled. Patients were divided in 4 groups. Group 1 (N. 15) and group 3 (N. 15) were cases in whom anesthesia was performed with standard monitoring plus the aid of Navigator® (Nav) or SmartPilot® View (SPV) display. Group 2 (N. 15) and group 4 (N. 15) were controls in whom anesthesia was performed with standard monitoring (heart rate, NIBP, SpO2, end-tidal CO2, end-expired sevoflurane concentration, train of four, Bispectral Index [Aspect Medical Systems, Natick, MA, USA] or Entropy [GE Healthcare]). Patients' vital parameters and end-expired sevoflurane concentration were recorded during anesthesia. All patients recovered uneventfully and showed hemodynamic stability. End-tidal sevoflurane concentrations values [median (min-max)], during maintenance of anesthesia, were significantly (P<0.05) lower in SPV [1.1% (0.8-1.5)] and Nav [1%(0.8-1.8)] groups compared to SPV-control group [1.5%(1-2.5)] and Nav-control group [1.5%(0.8-2)]. BIS and entropy values were respectively higher in the SPV group [53 (46-57)] compared to the control group [43 (37-51)] (P<0.05) and Nav group [53 (43-60)] compared to the control group [41 (35-51)] (P<0.05). No significant differences in Remifentanil dosing were observed in the four groups. Navigator® and SmartPilot® View may be of clinical use in monitoring adequacy of anesthesia. Both displays can optimize the administration and monitoring of anesthetic drugs during general anesthesia and may reduce the consumption of volatile anesthetic agents.

Identification of miRNA-103 in the Cellular Fraction of Human Peripheral Blood as a Potential Biomarker for Malignant Mesothelioma – A Pilot Study

PubMed Central

Weber, Daniel G.; Johnen, Georg; Bryk, Oleksandr; Jöckel, Karl-Heinz; Brüning, Thomas

2012-01-01

Background To date, no biomarkers with reasonable sensitivity and specificity for the early detection of malignant mesothelioma have been described. The use of microRNAs (miRNAs) as minimally-invasive biomarkers has opened new opportunities for the diagnosis of cancer, primarily because they exhibit tumor-specific expression profiles and have been commonly observed in blood of both cancer patients and healthy controls. The aim of this pilot study was to identify miRNAs in the cellular fraction of human peripheral blood as potential novel biomarkers for the detection of malignant mesothelioma. Methodology/Principal Findings Using oligonucleotide microarrays for biomarker identification the miRNA levels in the cellular fraction of human peripheral blood of mesothelioma patients and asbestos-exposed controls were analyzed. Using a threefold expression change in combination with a significance level of p<0.05, miR-103 was identified as a potential biomarker for malignant mesothelioma. Quantitative real-time PCR (qRT-PCR) was used for validation of miR-103 in 23 malignant mesothelioma patients, 17 asbestos-exposed controls, and 25 controls from the general population. For discrimination of mesothelioma patients from asbestos-exposed controls a sensitivity of 83% and a specificity of 71% were calculated, and for discrimination of mesothelioma patients from the general population a sensitivity of 78% and a specificity of 76%. Conclusions/Significance The results of this pilot study show that miR-103 is characterized by a promising sensitivity and specificity and might be a potential minimally-invasive biomarker for the diagnosis of mesothelioma. In addition, our results support the concept of using the cellular fraction of human blood for biomarker discovery. However, for early detection of malignant mesothelioma the feasibility of miR-103 alone or in combination with other biomarkers needs to be analyzed in a prospective study. PMID:22253921

Ring-Screening to Control Endemic Transmission of Taenia solium

PubMed Central

O'Neal, Seth E.; Moyano, Luz M.; Ayvar, Viterbo; Rodriguez, Silvia; Gavidia, Cesar; Wilkins, Patricia P.; Gilman, Robert H.; Garcia, Hector H.; Gonzalez, Armando E.

2014-01-01

Background Taenia solium is a major cause of preventable epilepsy in developing nations. Screening and treatment of human intestinal stage infection (taeniasis) within high-risk foci may reduce transmission and prevent epilepsy by limiting human exposure to infective eggs. We piloted a ring-strategy that involves screening and treatment for taeniasis among households located nearby pigs heavily-infected with the larval stage (cysticercosis). These pigs mark areas of increased transmission and can be identified by tongue examination. Methodology We selected two villages in northern Peru for a controlled prospective interventional cohort pilot study. In the intervention village (1,058 residents) we examined the tongues of all pigs every 4 months for nodules characteristic of cysticercosis. We then screened all residents living within 100-meters of any tongue-positive pig using enzyme-linked immunosorbent assay to detect Taenia antigens in stool. Residents with taeniasis were treated with niclosamide. In both the intervention and control (753 residents) we measured incidence of exposure by sampling the pig population every 4 months for serum antibodies against cysticercosis using enzyme-linked immunoelectrotransfer blot. Principal Findings Baseline seroincidence among pigs born during the study was 22.6 cases per 100 pigs per-month (95% confidence interval [CI] 17.0–30.0) in the intervention and 18.1 (95% CI 12.7–25.9) in the control. After one year we observed a 41% reduction in seroincidence in the intervention village compared to baseline (incidence rate ratio 0.59, 95% CI 0.41–0.87) while the seroincidence in the control village remained unchanged. At study end, the prevalence of taeniasis was nearly 4 times lower in the intervention than in the control (prevalence ratio 0.28, 95% CI 0.08–0.91). Conclusions/Significance Ring-screening reduced transmission of T. solium in this pilot study and may provide an effective and practical approach for regions where resources are limited. However, this strategy requires validation in larger populations over a greater period of time. PMID:25210748

Absence of accelerated atherosclerotic disease progression after intracoronary infusion of bone marrow derived mononuclear cells in patients with acute myocardial infarction--angiographic and intravascular ultrasound--results from the TErapia Celular Aplicada al Miocardio Pilot study.

PubMed

Arnold, Roman; Villa, Adolfo; Gutiérrez, Hipólito; Sánchez, Pedro L; Gimeno, Federico; Fernández, Maria E; Gutiérrez, Oliver; Mota, Pedro; Sánchez, Ana; García-Frade, Javier; Fernández-Avilés, Francisco; San Román, Jose A

2010-06-01

We tried to evaluate a putative negative effect on coronary atherosclerosis in patients receiving intracoronary infusion of unfractionated bone marrow mononuclear cells (BMMC) following an acute ST-elevation myocardial infarction. Peripheral blood mononuclear cells or enriched CD133(+) BMMC have been associated with accelerated atherosclerosis of the distal segment of the infarct related artery (IRA). Thirty-seven patients with ST-elevation myocardial infarction from the TECAM pilot study underwent intracoronary infusion of autologous BMMC 9 +/- 3.1 days after onset of symptoms. We compared angiographic changes from baseline to 9 months of follow-up in the distal non-stented segment of the IRA, as well as in the contralateral coronary artery, with a matched control group. A subgroup of 15 treated patients underwent additional IVUS within the distal segment of the IRA. No difference between stem cell and control group were found regarding changes in minimum lumen diameter (0.006 +/- 0.42 vs 0.06 +/- 0.41 mm, P = ns) and the percentage of stenosis (-2.68 +/- 12.33% vs -1.78 +/- 8.75%, P = ns) at follow-up. Likewise, no differences were seen regarding changes in the contralateral artery (minimum lumen diameter -0.004 +/- 0.54 mm vs -0.06 +/- 0.35 mm, P = ns). In the intravascular ultrasound substudy, no changes were demonstrated comparing baseline versus follow-up in maximum area stenosis and plaque volume. In this pilot study, analysis of a subgroup of patients found that intracoronary injection of unfractionated BMMC in patients with acute ST-elevation myocardial infarction was not associated with accelerated atherosclerosis progression at mid term. Prospective, randomised studies in large cohorts with long-term angiographic and intravascular ultrasound follow-up are necessary to determine the safety of this therapy. Copyright 2010 Mosby, Inc. All rights reserved.

Total and free cortisol levels during 1 μg, 25 μg, and 250 μg cosyntropin stimulation tests compared to insulin tolerance test: results of a randomized, prospective, pilot study.

PubMed

Peechakara, Seenia; Bena, James; Clarke, Nigel J; McPhaul, Michael J; Reitz, Richard E; Weil, Robert J; Recinos, Pablo; Kennedy, Laurence; Hamrahian, Amir H

2017-09-01

The appropriate cosyntropin dose during cosyntropin stimulation tests remains uncertain. We conducted a prospective, randomized pilot study to compare 1 μg IV low dose cosyntropin test, 25 μg IM medium dose cosyntropin test, and 250 μg IM standard dose cosyntropin test to evaluate secondary adrenal insufficiency. Insulin tolerance test was used as the gold standard. The study included patients with hypothalamic/pituitary disease (n  = 10) with at least one pituitary axis deficiency other than ACTH deficiency and controls (n  = 12). All tests were done in random order. Sensitivity and specificity were calculated for total cortisol and serum free cortisol cut-off levels during cosyntropin stimulation tests. The median (range) age and F/M sex ratios for patients and controls were 54 years (23-62), 2/8, and 33 years (21-51), 6/6, respectively. The best total cortisol cut-off during low dose cosyntropin test, medium dose cosyntropin test, 30 min and 60 min standard dose cosyntropin test were 14.6 μg/dL (100% sensitivity & specificity), 18.7 μg/dL (100% sensitivity, 88% specificity), 16.1 (100% sensitivity & specificity), and 19.5 μg/dL (100% sensitivity & specificity), respectively. There was no difference in the ROC curve for cortisol values between the cosyntropin stimulation tests (p  > 0.41). Using a cortisol cut-off of 18 μg/dL during cosyntropin stimulation tests, only cortisol level at 30 min during standard dose cosyntropin test provided discrimination similar to insulin tolerance test. The best peak free cortisol cut-off levels were 1 μg/dL for insulin tolerance test, 0.9 μg/dL for low dose cosyntropin test, 0.9 μg/dL for medium dose cosyntropin test, and 0.9 μg/dL and 1.3 μg/dL for 30 min and 60 min standard dose cosyntropin test, respectively. All cosyntropin stimulation tests had excellent correlations with insulin tolerance test, when appropriate cut-offs were used. This pilot study does not suggest an advantage in using 25 μg cosyntropin dose during the cosyntropin stimulation test. A serum free cortisol cut-off of 0.9 μg/dL may be used as pass criterion during low dose cosyntropin test, standard dose cosyntropin test cosyntropin test, and 30 min standard dose cosyntropin test.

Impact of emerging technologies on future combat aircraft agility

NASA Technical Reports Server (NTRS)

Nguyen, Luat T.; Gilert, William P.

1990-01-01

The foreseeable character of future within-visual-range air combat entails a degree of agility which calls for the integration of high-alpha aerodynamics, thrust vectoring, intimate pilot/vehicle interfaces, and advanced weapons/avionics suites, in prospective configurations. The primary technology-development programs currently contributing to these goals are presently discussed; they encompass the F-15 Short Takeoff and Landing/Maneuver Technology Demonstrator Program, the Enhanced Fighter Maneuverability Program, the High Angle-of-Attack Technology Program, and the X-29 Technology Demonstrator Program.

Recent results and prospects for NA62 experiment

NASA Astrophysics Data System (ADS)

Martellotti, Silvia; Aglieri Rinella, G.; Aliberti, R.; Ambrosino, F.; Ammendola, R.; Angelucci, B.; Antonelli, A.; Anzivino, G.; Arcidiacono, R.; Azhinenko, I.; Balev, S.; Barbanera, M.; Bendotti, J.; Biagioni, A.; Bician, L.; Biino, C.; Bizzeti, A.; Blazek, T.; Blik, A.; Bloch-Devaux, B.; Bolotov, V.; Bonaiuto, V.; Boretto, M.; Bragadireanu, M.; Britton, D.; Britvich, G.; Brunetti, M. B.; Bryman, D.; Bucci, F.; Butin, F.; Capitolo, E.; Capoccia, C.; Capussela, T.; Cassese, A.; Catinaccio, A.; Cecchetti, A.; Ceccucci, A.; Cenci, P.; Cerny, V.; Cerri, C.; Checcucci, B.; Chikilev, O.; Chiozzi, S.; Ciaranfi, R.; Collazuol, G.; Conovaloff, A.; Cooke, P.; Cooper, P.; Corradi, G.; Cortina Gil, E.; Costantini, F.; Cotorobai, F.; Cotta Ramusino, A.; Coward, D.; D'Agostini, G.; Dainton, J.; Dalpiaz, P.; Danielsson, H.; Degrange, J.; De Simone, N.; Di Filippo, D.; Di Lella, L.; Di Lorenzo, S.; Dixon, N.; Doble, N.; Dobrich, B.; Duk, V.; Elsha, V.; Engelfried, J.; Enik, T.; Estrada, N.; Falaleev, V.; Fantechi, R.; Fascianelli, V.; Federici, L.; Fedotov, S.; Fiorini, M.; Fry, J.; Fu, J.; Fucci, A.; Fulton, L.; Gallorini, S.; Galeotti, S.; Gamberini, E.; Gatignon, L.; Georgiev, G.; Gianoli, A.; Giorgi, M.; Giudici, S.; Glonti, L.; Goncalves Martins, A.; Gonnella, F.; Goudzovski, E.; Guida, R.; Gushchin, E.; Hahn, F.; Hallgren, B.; Heath, H.; Herman, F.; Husek, T.; Hutanu, O.; Hutchcroft, D.; Iacobuzio, L.; Iacopini, E.; Imbergamo, E.; Jamet, O.; Jarron, P.; Jones, E.; Kampf, K.; Kaplon, J.; Kekelidze, V.; Kholodenko, S.; Khoriauli, G.; Khotyantsev, A.; Khudyakov, A.; Kiryushin, Yu.; Kleimenova, A.; Kleinknecht, K.; Kluge, A.; Koval, M.; Kozhuharov, V.; Krivda, M.; Kucerova, Z.; Kudenko, Y.; Kunze, J.; Lamanna, G.; Latino, G.; Lazzeroni, C.; Lehmann-Miotto, G.; Lenci, R.; Lenti, M.; Leonardi, E.; Lichard, P.; Lietava, R.; Litov, L.; Lollini, R.; Lomidze, D.; Lonardo, A.; Lupi, M.; Lurkin, N.; McCormick, K.; Madigozhin, D.; Maire, G.; Mandeiro, C.; Mannelli, I.; Mannocchi, G.; Mapelli, A.; Marchetto, F.; Marchevski, R.; Martellotti, S.; Massarotti, P.; Massri, K.; Matak, P.; Maurice, E.; Mefodev, A.; Menichetti, E.; Minucci, E.; Mirra, M.; Misheva, M.; Molokanova, N.; Morant, J.; Morel, M.; Moulson, M.; Movchan, S.; Munday, D.; Napolitano, M.; Neri, I.; Newson, F.; Norton, A.; Noy, M.; Nuessle, G.; Numao, T.; Obraztsov, V.; Ostankov, A.; Padolski, S.; Page, R.; Palladino, V.; Paoluzzi, G.; Parkinson, C.; Pedreschi, E.; Pepe, M.; Perez Gomez, F.; Perrin-Terrin, M.; Peruzzo, L.; Petrov, P.; Petrucci, F.; Piandani, R.; Piccini, M.; Pietreanu, D.; Pinzino, J.; Polenkevich, I.; Pontisso, L.; Potrebenikov, Yu.; Protopopescu, D.; Raffaelli, F.; Raggi, M.; Riedler, P.; Romano, A.; Rubin, P.; Ruggiero, G.; Russo, V.; Ryjov, V.; Salamon, A.; Salina, G.; Samsonov, V.; Santoni, C.; Saracino, G.; Sargeni, F.; Semenov, V.; Sergi, A.; Serra, M.; Shaikhiev, A.; Shkarovskiy, S.; Skillicorn, I.; Soldi, D.; Sotnikov, A.; Sougonyaev, V.; Sozzi, M.; Spadaro, T.; Spinella, F.; Staley, R.; Sturgess, A.; Sutcliffe, P.; Szilasi, N.; Tagnani, D.; Trilov, S.; Valdata-Nappi, M.; Valente, P.; Vasile, M.; Vassilieva, T.; Velghe, B.; Veltri, M.; Venditti, S.; Vicini, P.; Volpe, R.; Vormstein, M.; Wahl, H.; Wanke, R.; Wertelaers, P.; Winhart, A.; Winston, R.; Wrona, B.; Yushchenko, O.; Zamkovsky, M.; Zinchenko, A.; NA62 Collaboration

2017-04-01

The K+ →π+ ν ν ‾ decay is theoretically one of the cleanest meson decays and so a good place to look for indirect effects of new physics complementary to LHC searches. The NA62 experiment at CERN is designed to measure the branching ratio of this decay with 10% precision. NA62 was commissioned in October 2014, took data in pilot runs in 2014 and 2015. The NA62 experimental setup is illustrated and data quality is reported.

On operator strategic behavior

NASA Technical Reports Server (NTRS)

Hancock, P. A.

1991-01-01

Deeper and more detailed knowledge as to how human operators such as pilots respond, singly and in groups, to demands on their performance which arise from technical systems will support the manipulation of such systems' design in order to accommodate the foibles of human behavior. Efforts to understand how self-autonomy impacts strategic behavior and such related issues as error generation/recognition/correction are still in their infancy. The present treatment offers both general and aviation-specific definitions of strategic behavior as precursors of prospective investigations.

Continuous Subcutaneous Insulin Infusion in Children: A Pilot Study Validating a Protocol to Avoid Hypoglycemia at Initiation.

PubMed

Manousaki, Despoina; Deladoëy, Johnny; Geoffroy, Louis; Olivier, Patricia

2017-01-01

The occurrence of hypoglycemia and hyperglycemia during the first days after transition to continuous subcutaneous insulin infusion (CSII) in patients with type 1 diabetes has not been systematically studied in children. The aim of this prospective study was to demonstrate that the protocol applied in our diabetes clinic is safe at CSII initiation in children. We assessed 22 pediatric patients with type 1 diabetes, using continuous glucose monitoring (CGM) before and after CSII initiation (±3 days). After CSII initiation, there was no difference in the rates of hypoglycemic events expressed as relative rates (RRs) per person-reading (RR = 0.85, p  = 0.52, 95% CI 0.52-1.39), as well as in the number of prolonged hypoglycemic events (>1 h) per day (RR = 1.12, p  = 0.56, 95% CI 0.75-1.68). We observed only a trend toward prolonged episodes of hyperglycemia after pump initiation (RR = 1.52, p  = 0.06, 95% CI 0.97-2.35). Our study is the first to assess, through CGM and in a prospective way, the impact of a CSII initiation protocol on glycemic values. Our protocol provides a safe model to avoid hypoglycemia at CSII initiation in children. www.ClinicalTrials.gov, identifier NCT01840358.

Cognitive abilities of health and art college students a pilot study.

PubMed

AlAbdulwahab, Sami S; Kachanathu, Shaji John; AlKhamees, Abdullah K

2016-05-01

[Purpose] The selection of a college major is a struggle that high school students undergo every year; however, there is a dearth of studies examining the role of cognitive ability tests as a tool for determining the aptitude of prospective students. Hence, the purpose of this study was to assess cognitive ability differences among students. [Subjects and Methods] A convenience sample of 60 college students (30 health science and 30 art students) with a mean age of 19 ± 1.6 years, voluntarily participated in this study. Cognitive ability was assessed using the self-administered Cognitive Assessment of Minnesota (CAM) scale under the supervision of a researcher. [Results] The findings indicated that there was a significant cognitive ability difference between health science and art students, especially in the cognitive components of knowledge, calculation, and thinking. However, the difference in the social cognitive component of both the health science and art students was not significant. [Conclusion] The results indicate that the health science students' cognitive abilities were better than those of the art students. This finding implies that it is important for high school graduates to undertake a cognitive ability assessment prior to choosing a subject major. Hence, it is recommended that cognitive scales should be included as an aptitude assessment tool for the decision-makers and prospective students to determine an appropriate career, since it might reduce the percentage of university drop-out ratio.

Microalgal drying and cell disruption--recent advances.

PubMed

Show, Kuan-Yeow; Lee, Duu-Jong; Tay, Joo-Hwa; Lee, Tse-Min; Chang, Jo-Shu

2015-05-01

Production of intracellular metabolites or biofuels from algae involves various processing steps, and extensive work on laboratory- and pilot-scale algae cultivation, harvesting and processing has been reported. As algal drying and cell disruption are integral processes of the unit operations, this review examines recent advances in algal drying and disruption for nutrition or biofuel production. Challenges and prospects of the processing are also outlined. Engineering improvements in addressing the challenges of energy efficiency and cost-effective and rigorous techno-economic analyses for a clearer prospect comparison between different processing methods are highlighted. Holistic life cycle assessments need to be conducted in assessing the energy balance and the potential environmental impacts of algal processing. The review aims to provide useful information for future development of efficient and commercially viable algal food products and biofuels production. Copyright © 2014 Elsevier Ltd. All rights reserved.

Analysis of GD2/GM2 synthase mRNA as a biomarker for small cell lung cancer.

PubMed

Chen, Lin-Chi; Brown, Andrew B; Cheung, Irene Y; Cheung, Nai-Kong V; Kris, Mark G; Krug, Lee M

2010-02-01

GD2/GM2 synthase is a key enzyme in the synthesis of GD2 and GM2 gangliosides found on the surface of neuroblastoma and small cell lung carcinoma (SCLC) cells. In neuroblastoma, persistent levels of GD2/GM2 synthase RNA in bone marrow (BM) following therapy portend poorer progression-free and overall survival. We conducted this study to determine if GD2/GM2 synthase RNA could be detected in SCLC cell lines and human tissues, and whether mRNA transcript levels corresponded with disease status. Initially, a pilot study enrolled patients with SCLC to determine the rate of GD2 expression at various points in the patients' disease course. Peripheral blood (PB), bone marrow and tumor tissues were used to measure GD2/GM2 synthase levels. In addition, SCLC cell lines were analyzed for GD2/GM2 synthase expression. Based on data from that initial analysis, a prospective trial was developed enrolling patients with newly diagnosed SCLC and following them serially. GD2/GM2 synthase transcript was determined by a sensitive quantitative reverse transcription-PCR (qRT-PCR) assay and normalized to glyceraldehyde-3-phosphate dehydrogenase (GAPDH). Six SCLC cell lines were assayed for expression of GD2/GM2 synthase, and high expression was detected in all. GD2/GM2 synthase transcript levels were obtained from tumor tissue, BM, or PB of 29 patients in the pilot study. 6/10 (60%) tumor tissues or BM samples were positive (median 332.7 units; range 13-2323 units); 8/19 (42%) untreated patients were GD2/GM2 synthase positive in their PB prior to beginning therapy (median 10.2; range 5.1-32.2); 3/4 (75%) patients who were first tested when they developed recurrent disease were positive in their PB (median 16.1; range 8.5-19.9). The fourth patient had an initial value of 2.0 (negative), which increased to 8.4 (positive) within 1 month without treatment. Seven of 12 patients with baseline positive GD2/GM2 synthase values had post-treatment levels measured, all of which were 50% decrease following successful treatment. Patients in the prospective trial demonstrated lower rates of positivity, with only 3/26 (12%) patients exhibiting detectable transcript levels in the peripheral blood prior to treatment. All 3 of these patients had their transcript levels fall below 5 after treatment. 11/26 patients had baseline levels of zero. Bone marrow was drawn at baseline on 7 patients in the prospective trial and 3 (43%) had transcript levels above 5 (range 0.65-27.43 units). There was no correlation between elevated levels in the BM and elevated levels in the PB. Although initial studies demonstrated that GD2/GM2 synthase transcripts were measurable in the peripheral blood of SCLC patients at diagnosis and declined with successful treatment, in a separate prospective study, these results could not be confirmed. Thus, GD2/GM2 is not a reliable biomarker in SCLC. Copyright 2009 Elsevier Ireland Ltd. All rights reserved.

Daily computer usage correlated with undergraduate students' musculoskeletal symptoms.

PubMed

Chang, Che-Hsu Joe; Amick, Benjamin C; Menendez, Cammie Chaumont; Katz, Jeffrey N; Johnson, Peter W; Robertson, Michelle; Dennerlein, Jack Tigh

2007-06-01

A pilot prospective study was performed to examine the relationships between daily computer usage time and musculoskeletal symptoms on undergraduate students. For three separate 1-week study periods distributed over a semester, 27 students reported body part-specific musculoskeletal symptoms three to five times daily. Daily computer usage time for the 24-hr period preceding each symptom report was calculated from computer input device activities measured directly by software loaded on each participant's primary computer. General Estimating Equation models tested the relationships between daily computer usage and symptom reporting. Daily computer usage longer than 3 hr was significantly associated with an odds ratio 1.50 (1.01-2.25) of reporting symptoms. Odds of reporting symptoms also increased with quartiles of daily exposure. These data suggest a potential dose-response relationship between daily computer usage time and musculoskeletal symptoms.

[Psychiatric outpatient consultation-liaison services--how do they work and what are their effects: results of a pilot study?].

PubMed

Kirchen-Peters, Sabine; Fehrenbach, Rosa-Adelinde; Diefenbacher, Albert

2012-11-01

Many patients benefit from interventions performed by the psychiatric liaison service. Prospective longitudinal study of community dwelling elderly patients supplemented by a questionnaire answered by family members, as well as expert interviews with the members of the consultation-liaison team and semi-structured interviews with family members. The majority of patients had some benefit from the liaison psychiatric interventions, access to care was improved and lack of specialist support was reduced. In addition there was some cost offset due to prevention of admissions to nursing homes and inpatient hospital treatment. With regard to demographic developments gerontopsychiatric liaison services should be integrated into the present system of health care. This should be supported by adjusting judicial obstacles that hamper such strategies. © Georg Thieme Verlag KG Stuttgart · New York.

Ultrasound to Detect Pressure-related Deep Tissue Injuries in Adults Admitted via the Emergency Department: A Prospective, Descriptive, Pilot Study.

PubMed

Scheiner, Jonathan; Farid, Karen; Raden, Mark; Demisse, Seleshi

2017-03-01

Stage 4 pressure ulcers (PUs) start with tissue death at the level of the bone, also known as deep tissue injury (DTI). Studies have shown the appearance of DTI on the skin is delayed for several days after the original pressure-related injury to the deep soft tissues. Studies also suggest DTI can be seen using ultrasound (US) technology. A prospective, descriptive, correlational pilot study was conducted to evaluate the use of US technology to detect DTI in the soft tissues that are not visible on the skin upon hospital admission. Study participants included a convenience sample of 33 persons at risk for PUs (ie, Braden score <18) admitted through the emergency department. Each participant had US scans of 13 common PU body sites. All scans were documented in the radiologist report in the electronic medical record. Creatinine phosphokinase, calcium levels, and urine myoglobin levels also were assessed upon enrollment. Skin failure risk factors (SFRFs), including fever, hypotension, weight loss, coagulopathy, and acidosis/respiratory failure, also were documented. Patients were examined for skin PUs every day for 7 days after US scan. Twenty-three (23) patients completed the study. US scans identified pressure necrosis at 2 levels: bone (54 positive [US+]) and subcutaneous (SC); 79 US+, respectively). US+ bone sites resulted in 5 PUs appearing 6 to 7 days post-admission (sensitivity = 100%, specificity 84.7%, positive predictive value 10%, and negative predictive value 100%), indicating all DTI that later became purple skin DTI were detected by the US. US+ SC sites, located immediately under the skin, yielded 5 PUs appearing on day 2 after admission (sensitivity 100%, specificity 74.8%, positive predictive value 6.3%, and negative predictive value 100%). The participants with PU occurrence in both bone and SC groups had low Braden scores (bone group mean = 13.25, SC group mean = 11.2). Study patients who were positive for PU also had >4 SFRFs. Creatinine phosphokinase, calcium, and myoglobin levels were inconsistent and did not correlate with US+ scans. These observations warrant larger studies to confirm findings and optimize the validity of US screening for DTI in select populations, which may help improve protocols of care and PU admission documentation. The preliminary results suggest inclusion of the Braden Scale score and known PU risk factors may improve the positive predictive value of this test.

A prospective pilot cohort analysis of crash characteristics and pattern of injuries in riders and pillion passengers involved in motorcycle crashes in an urban area in Cameroon: lessons for prevention.

PubMed

Chichom-Mefire, Alain; Atashili, Julius; Tsiagadigui, Jean G; Fon-Awah, Clovis; Ngowe-Ngowe, Marcelin

2015-09-18

Low and middle-income countries carry over ninety per cent of the burden of injury related mortality and disability. Motorcycles are gradually becoming a major mode of transportation in Cameroon and other African countries in the absence of an organized public transport. Consequently, the contribution of motorcycle crash to injury-related deaths seems to be on the rise. Currently, data addressing motorcycle crash characteristics, pattern, and severity of motorcycle-related injuries in Cameroon are scarce. We hypothesised that head and limb injuries are the most frequent cause of morbidity and mortality and equally affect riders and pillion passengers. This hospital-based prospective pilot cohort analysis involving 405 motorcycle crashes and 621 injury victims was conducted in Laquintinie Hospital, a large centre located in an urban area in Cameroon. All motorcycle riders and passengers received in the emergency department over a 4 months period with an injury following a traffic related crash were included. Crash characteristics and type, anatomical location and severity of injuries were recorded and analysed comparing the pattern of injuries between riders and pillion passengers involved in motorcyclecrashes. This pilot analysis is expected to propose a snapshot of motorcycle injuries in Douala and will be followed by a larger analysis over a longer period. We recorded a majority of motorcycle versus car and motorcycle versus motorcycle collisions. Most of these crashes occurred over the week-end and in the night. Helmet use was almost inexistent. We observed that females aged above 40 years represented the majority of pillion passengers. This accounted for the sex-ratio of 1.1/1. A total of 1311 injuries were identified in our patients, giving a mean of 2.1 injuries per victim. The head and the limbs were the most affected anatomical areas. Riders carried a higher risk of sustaining an injury to head and neck than pillion passengers. Riders and pillion passengers carried equal risk of injury to the lower limbs. Emergency room mortality was 4.3 % and riders were more likely to die than pillion passengers. This study has identified females aged above 40 years as a special vulnerable group in Douala. It also carries strong messages useful for the implementation of preventive measures and management of patients injured in motorcycle-related crash in general.

Crotalidae polyvalent immune Fab: in patients with North American crotaline envenomation.

PubMed

Keating, Gillian M

2011-04-01

Crotalidae polyvalent immune Fab is an antivenom comprising purified, sheep-derived, Fab IgG fragments and is indicated for use in patients with North American crotaline envenomation. Crotalidae polyvalent immune Fab is produced using four North American snake venoms: Crotalus atrox, Crotalus adamanteus, Crotalus scutulatus, and Agkistrodon piscivorus. Intravenous crotalidae polyvalent immune Fab was effective in patients aged ≥10 years who had minimal or moderate envenomation by a North American crotaline, who presented within 6 hours of the snakebite, and who had progression of the envenomation syndrome, according to the results of two prospective trials. One trial was a noncomparative, multicenter pilot study and the other trial was a randomized, open-label, multicenter trial in which patients received scheduled or 'as needed' administration of crotalidae polyvalent immune Fab after initial control had been achieved. A prospective, postmarketing trial demonstrated the efficacy of crotalidae polyvalent immune Fab in confirmed Crotalus viridis helleri envenomation (indicating cross-protection against a venom not used in its production). Results of these prospective trials are supported by the findings of additional (mainly retrospective) studies demonstrating the efficacy of crotalidae polyvalent immune Fab in patients with crotaline envenomation, including patients with severe envenomation, pediatric patients, and patients with symptoms of neurotoxicity. Despite treatment with crotalidae polyvalent immune Fab, patients may experience delayed-onset or recurrent venom effects (e.g. coagulopathy). Intravenous crotalidae polyvalent immune Fab was generally well tolerated; acute hypersensitivity reactions (e.g. urticaria, rash, pruritus) were the most commonly occurring adverse event. © 2011 Adis Data Information BV. All rights reserved.

A pediatric epilepsy diagnostic tool for use in resource-limited settings: A pilot study.

PubMed

Patel, Archana A; Ciccone, Ornella; Njau, Adrian; Shanungu, Sandra; Grollnek, Alice Kabwe; Fredrick, Francis; Hodgeman, Ryan; Sideridis, Georgios D; Kapur, Kush; Harini, Chellamani; Kija, Edward; Peters, Jurriaan M

2016-06-01

It is estimated that nearly 80% of the 50 million people affected with epilepsy globally live in regions where specialist care and diagnostic tests are scarce and care is often delivered through a primary health provider with limited training. To improve diagnostic accuracy of the history and physical examination, we developed and piloted a questionnaire to discriminate between focal versus generalized epilepsy, with the future goal to guide medication choices. Through literature review and retrospective chart review of 75 children with epilepsy at Boston Children's Hospital, a 15-item questionnaire was developed. Simple motor seizures were excluded for the purposes of this questionnaire. The questionnaire was then translated in local dialects and prospectively validated at Muhimbili National Hospital in Dar Es Salaam, Tanzania, and University Teaching Hospital in Lusaka, Zambia. Children 6months-18years of age with suspected or active epilepsy were identified, and a nonphysician administered the questionnaire to the patient's caregiver. Next, each patient was evaluated by a pediatric neurologist blinded to the questionnaire results, and together with locally obtained but remotely interpreted EEG, an electroclinical diagnosis was made. The questionnaire data were compared with this clinical gold standard. A total of 59 children participated: 28 from Tanzania and 31 from Zambia. Sixteen patients were excluded: 5 were excluded because of incomplete data, and 11 did not meet criteria for epilepsy based on initial screening questions. Of the remaining 43 patients, 28 had focal or multifocal epilepsy (65%), and 15 (35%) had generalized epilepsy. The questionnaire had a sensitivity of 78% and positive predictive value of 81.5%. Data were analyzed using a Rasch model, testing the questionnaire's internal consistency, reliability, and its discriminative validity in classifying focal versus generalized epilepsy against an electroclinical diagnosis. The mean epilepsy score for focal epilepsy was 0.084 logits compared with -1.147 logits for generalized epilepsy, demonstrating a large effect size [F (1, 41)=13.490, p<0.001]. Our questionnaire provides a straightforward method to improve diagnostic accuracy, and could assist in bridging the diagnostic gap in pediatric epilepsy in resource-limited settings. This tool was specifically designed to be easily implemented by any healthcare provider. This pilot study prompts broader prospective validation in additional settings for further refinement, and for performance assessment of impact on provider's practice, ability to guide medication choices, and ultimately improve treatment outcomes in resource-limited regions. Copyright © 2016 Elsevier Inc. All rights reserved.

Doxorubicin and deracoxib adjuvant therapy for canine splenic hemangiosarcoma: A pilot study

PubMed Central

Kahn, S. Anthony; Mullin, Christine M.; de Lorimier, Louis-Philippe; Burgess, Kristine E.; Risbon, Rebecca E.; Fred, Rogers M.; Drobatz, Kenneth; Clifford, Craig A.

2013-01-01

Canine hemangiosarcoma (HSA) is a highly malignant tumor for which standard chemotherapy has done little to substantially improve survival. Cyclooxygenase-2 (Cox-2) plays a role in the formation, growth, and metastasis of tumors and inhibitors have demonstrated therapeutic benefit with certain canine cancers. In this prospective study, 21 dogs received adjuvant therapy combining the selective Cox-2 inhibitor deracoxib with doxorubicin, following splenectomy for HSA. The combination was well-tolerated with only low-grade gastrointestinal and hematologic toxicities noted. An overall median survival of 150 days (range; 21 to 1506 days) was noted. Although there was no significant difference in survival based upon stage of disease, dogs with stage III HSA (n = 11) had a median survival of 149 days, which appears to be longer than previously reported. Further studies are warranted to evaluate the potential benefit of Cox-2 inhibitors in the treatment of canine HSA. PMID:23997259

The Role of Family Phenomena in Posttraumatic Stress in Youth

PubMed Central

Deatrick, Janet A.

2010-01-01

Topic Youth face trauma that can cause posttraumatic stress (PTS). Purpose 1). To identify the family phenomena used in youth PTS research; and 2). Critically examine the research findings regarding the relationship between family phenomena and youth PTS. Sources Systematic literature review in PsycInfo, PILOTS, CINAHL, and MEDLINE. Twenty-six empirical articles met inclusion criteria. Conclusion Measurement of family phenomena included family functioning, support, environment, expressiveness, relationships, cohesion, communication, satisfaction, life events related to family, parental style of influence, and parental bonding. Few studies gave clear conceptualization of family or family phenomena. Empirical findings from the 26 studies indicate inconsistent empirical relationships between family phenomena and youth PTS, though a majority of the prospective studies support a relationship between family phenomena and youth PTS. Future directions for leadership by psychiatric nurses in this area of research and practice are recommended. PMID:21344778

Effect of chronic low level manganese exposure on postural balance: A pilot study of residents in southwest Ohio

PubMed Central

Standridge, J. S.; Bhattacharya, Amit; Succop, Paul; Cox, Cyndy; Haynes, Erin

2009-01-01

OBJECTIVE The objective of this study was to determine the effect of non-occupational exposure to manganese on postural balance. METHODS Residents living near a ferromanganese refinery provided hair and blood samples after postural balance testing. The relationship between hair manganese and postural balance was analyzed with logistic regression. Following covariate adjustment, postural balance was compared with control data by analysis of covariance. RESULTS Mean hair manganese was 4.4 µg/g. A significantly positive association was found between hair manganese and sway area (EO, p=0.05; EC, p=0.04) and sway length (EO, p=0.05; EC, p=0.04). Postural balance of residents was significantly larger than controls in 5 out of 8 postural balance outcomes. CONCLUSION Preliminary findings suggest subclinical impairment in postural balance among residents chronically exposed to ambient Mn. A prospective study with a larger sample size is warranted. PMID:19092498

Monitoring Progression of Amyotrophic Lateral Sclerosis Using Ultrasound Morpho-Textural Muscle Biomarkers: A Pilot Study.

PubMed

Martínez-Payá, Jacinto J; Ríos-Díaz, José; Medina-Mirapeix, Francesc; Vázquez-Costa, Juan F; Del Baño-Aledo, María Elena

2018-01-01

The need is increasing for progression biomarkers that allow the loss of motor neurons in amyotrophic lateral sclerosis (ALS) to be monitored in clinical trials. In this prospective longitudinal study, muscle thickness, echointensity, echovariation and gray level co-occurrence matrix textural features are examined as possible progression ultrasound biomarkers in ALS patients during a 5-mo follow-up period. We subjected 13 patients to 3 measurements for 20 wk. They showed a significant loss of muscle, an evident tendency to loss of thickness and increased echointensity and echovariation. In regard to textural parameters, muscle heterogeneity tended to increase as a result of the neoformation of non-contractile tissue through denervation. Considering some limitations of the study, the quantitative muscle ultrasound biomarkers evaluated showed a promising ability to monitor patients affected by ALS. Copyright © 2018 World Federation for Ultrasound in Medicine and Biology. Published by Elsevier Inc. All rights reserved.

ATG-Fresenius or daclizumab induction therapy in immunologically high risk kidney recipients: a prospective randomized pilot trial.

PubMed

Kim, Min Jeong; Tsinalis, Dimitrios; Franz, Stefan; Binet, Isabelle; Gürke, Lorenz; Mihatsch, Michael J; Steiger, Jürg; Thiel, Gilbert; Dickenmann, Michael

2008-01-01

Despite all the advantages in the immunosuppressive therapy, kidney transplantation in immunologically high risk patients remains a challenge. Ideally, an induction therapy should provide maximal graft protection, while adverse events rate and costs remain as low as possible. Immunologically high risk kidney recipients with CDC-PRA ł 25% within the last 3 years, a positive B-cell CDC-crossmatch or graft loss due to rejection within 3 years following a prior transplantation, were randomized 1:1 to receive ATG-Fresenius (ATG-F) (9 mg/kg day 0; 3 mg/kg day 1-4) or Daclizumab therapy (1 mg/kg day 0, 14, 28, 42, 56) in a pilot study. Additional immunosuppression consisted of cyclosporine, mycophenolate mofetil, and steroids. 11 patients were included in each group. The patient (90% in ATG-F; 100% in Daclizumab) and graft survival (censored for death) (100% in ATG-F; 90% in Daclizumab) and the mean creatinine concentration at 24 months (139+/-68 mol/l in ATG-F; 176+/-103 mol/l in Daclizumab) were similar in both groups. More severe graft rejections (3 vascular rejections in Daclizumab) and adverse events (5.3/patient in ATG-F; 6.7/patient in Daclizumab) were observed in the Daclizumab group. The costs for hospitalization/ day within 24 months were lower in ATG-F (2.32+/-3.51 USD vs. 12.25+/-9.75 USD; p=0.02) resulting in an average cost-difference of more than 10'435 USD /patient. In this pilot trial, both treatments were comparably successful regarding graft and patient outcome.

Online detection of fetal acidemia during labour by testing synchronization of EEG and heart rate: a prospective study in fetal sheep.

PubMed

Wang, Xiaogang; Durosier, L Daniel; Ross, Michael G; Richardson, Bryan S; Frasch, Martin G

2014-01-01

Severe fetal acidemia during labour can result in life-lasting neurological deficits, but the timely detection of this condition is often not possible. This is because the positive predictive value (PPV) of fetal heart rate (FHR) monitoring, the mainstay of fetal health surveillance during labour, to detect concerning fetal acidemia is around 50%. In fetal sheep model of human labour, we reported that severe fetal acidemia (pH<7.00) during repetitive umbilical cord occlusions (UCOs) is preceded ∼60 minutes by the synchronization of electroencephalogram (EEG) and FHR. However, EEG and FHR are cyclic and noisy, and although the synchronization might be visually evident, it is challenging to detect automatically, a necessary condition for bedside utility. Here we present and validate a novel non-parametric statistical method to detect fetal acidemia during labour by using EEG and FHR. The underlying algorithm handles non-stationary and noisy data by recording number of abnormal episodes in both EEG and FHR. A logistic regression is then deployed to test whether these episodes are significantly related to each other. We then apply the method in a prospective study of human labour using fetal sheep model (n = 20). Our results render a PPV of 68% for detecting impending severe fetal acidemia ∼60 min prior to pH drop to less than 7.00 with 100% negative predictive value. We conclude that this method has a great potential to improve PPV for detection of fetal acidemia when it is implemented at the bedside. We outline directions for further refinement of the algorithm that will be achieved by analyzing larger data sets acquired in prospective human pilot studies.

Hypomagnesemia in brachycephalic dogs.

PubMed

Mellema, M S; Hoareau, G L

2014-01-01

Brachycephalic dogs are at risk for arterial hypertension and obstructive sleep apnea, which are both associated with chronic magnesium (Mg) depletion. To compare the period prevalence of hypomagnesemia between Boxers and Bulldogs presented to a referral teaching hospital. To screen a group of Bulldogs for evidence of hypomagnesemia, and to obtain pilot data regarding the utility of parenteral Mg tolerance testing (PMgTT) in the diagnosis of whole-body Mg deficiency. Chemistry laboratory submissions were retrospectively analyzed for serum total Mg (tMg) in Boxers and Bulldogs. Prospectively, 16 healthy client-owned Bulldogs were enrolled. Retrospective case study. tMg concentrations were compared between Boxers and Bulldogs. Dogs with low serum albumin or high serum creatinine concentrations were excluded. Prospectively, ionized Mg (iMg), tMg, and arterial blood pressure were measured and iMg-to-tMg ratio (iMg : tMg) was calculated. Parenteral Mg tolerance testing (PMgTT) was performed in 3/16 dogs. In the retrospective study, period prevalence of hypomagnesemia was 4.7% in Boxers and 15% in Bulldogs (P = .02). The risk ratio for hypomagnesemia in Bulldogs was 1.8 when compared to Boxers (CI: 1.3-2.7). In the prospective study, iMg was [median (interquartile)] 0.43 (0.42-0.46) mmol/L (reference range 0.4-0.52), tMg was 1.9 (1.8-1.9) mg/dL (reference range 1.9-2.5). iMg : tMg was [mean (±SD)] 0.59 ± 0.04. Percentage retention after PMgTT were 55%, 95%, and 67%, respectively. Mg deficiency is common in Bulldogs and could contribute to comorbidities often observed in this breed. iMg : tMg and PMgTT might prove helpful in detecting chronic subclinical Mg deficiency. Copyright © 2014 by the American College of Veterinary Internal Medicine.

A pilot study to assess the effectiveness and cost of routine universal use of peracetic acid sporicidal wipes in a real clinical environment.

PubMed

Saha, Avinandan; Botha, Stefan Louis; Weaving, Paul; Satta, Giovanni

2016-11-01

Peracetic acid sporicidal wipes have been shown to be an effective disinfectant, but in controlled test environments. Their high cost may restrict use. This pilot study investigated the efficacy and compared the costs of routine universal use of peracetic acid sporicidal wipes versus sporicidal quaternary ammonium compound and alcohol wipes in the disinfection of a hospital environment. The routine universal use of peracetic acid wipes (Clinell Sporicidal; GAMA Healthcare Ltd, London, UK) was allocated to a study ward, whereas the control ward continued with the use of quaternary ammonium compound wipes (Tuffie 5; Vernacare, Bolton, UK) and alcohol wipes (PDI Sani-Cloth 70; PDI, Flint, UK). Twenty high-touch areas in the 2 wards were sampled for the presence of indicator organisms. The weekly detection rates of indicator organisms and weekly healthcare associated infection (HCAI) rates in the 2 wards were compared and examined for decreasing trends over the trial period. The detection rates of indicator organisms and HCAI rates were not significantly different in the 2 wards, and did not decrease significantly over the trial period. However, the peracetic acid wipes seem to be more effective against gram-negative organisms but at a significantly higher cost. Further prospective studies are needed to assess the cost-effectiveness of peracetic acid wipes. Copyright © 2016 Association for Professionals in Infection Control and Epidemiology, Inc. Published by Elsevier Inc. All rights reserved.

Promoting Hand Hygiene With a Lighting Prompt.

PubMed

Diegel-Vacek, Lauren; Ryan, Catherine

2016-10-01

The objective of this pilot study was to assess an automatic sink light design intervention as a prompt for clinician hand hygiene (as defined by World Health Organization [WHO]). Healthcare-associated infections (HAIs) are still leading causes of morbidity and mortality and contribute to burdens on our healthcare system. Hand hygiene has been related to reducing the rate of HAIs and positively impacting both patient and hospital outcomes. This pilot study was a prospective, longitudinal observational study of a convenience sample of healthcare clinicians. In one inpatient room, clinicians were exposed to a hand hygiene reminder that consisted of a light turning on over the sink as they entered. A control room (the adjacent inpatient room) did not have the intervention. A total of 88 clinician encounters were monitored during the study. On the first observation day at the initial activation of the signal light system, the percentage of clinicians performing hand hygiene upon entering a room was only 7% in the control room and 23% in the intervention room. During the second observation (Day 14), those percentages were 16% in the control room and 30% in the intervention room. During the third observation (Day 21), those percentages were 23% in the control room and 23% in the intervention room. The healthcare system frequently relies on expensive technology to improve healthcare delivery, but implementation of low-cost, low-technology methods such as this light may be effective in prompting hand hygiene. © The Author(s) 2016.

Role of glucocorticoids on inflammatory response in nonimmunosuppressed patients with pneumonia: a pilot study.

PubMed

Montón, C; Ewig, S; Torres, A; El-Ebiary, M; Filella, X; Rañó, A; Xaubet, A

1999-07-01

The aim of the study was to assess the potential role of glucocorticoids (GC) in modulating systemic and pulmonary inflammatory responses in mechanically ventilated patients with severe pneumonia. Twenty mechanically ventilated patients with pneumonia treated at a respiratory intensive care unit (RICU) of a 1,000-bed teaching hospital were prospectively studied. All patients had received prior antimicrobial treatment. Eleven patients received GC (mean+/-SD dose of i.v. methylprednisolone 677+/-508 mg for 9+/-7 days), mainly for bronchial dilatation. Serum and bronchoalveolar lavage fluid (BALF) tumour necrosis factor (TNF)-alpha, interleukin (IL)-1beta, IL-6 and C-reactive protein levels were measured in all patients. The inflammatory response was attenuated in patients receiving GC, both systemically (IL-6 1,089+/-342 versus 630+/-385 pg x mL(-1), p=0.03; C-reactive protein 34+/-5 versus 19+/-5 mg x L(-1), p=0.04) and locally in BALF (TNF-alpha 118+/-50 versus 24+/-5 pg x mL(-1), p= 0.05; neutrophil count: 2.4+/-1.1 x 10(9) cells x L(-1) (93+/-3%) versus 1.9+/-1.8 x 10(9) cells x L(-1) (57+/-16%), p=0.03). Four of the 11 (36%) patients receiving GC died compared to six (67%) who were not receiving GC (p=0.37). The present pilot study suggests that glucocorticoids decrease systemic and lung inflammatory responses in mechanically ventilated patients with severe pneumonia receiving antimicrobial treatment.

Feasibility and pilot study of the Pediatric Anesthesia NeuroDevelopment Assessment (PANDA) project.

PubMed

Sun, Lena S; Li, Guohua; DiMaggio, Charles J; Byrne, Mary W; Ing, Caleb; Miller, Tonya L K; Bellinger, David C; Han, Sena; McGowan, Francis X

2012-10-01

Animal studies have documented that exposure of the developing brain to commonly used anesthetic agents induces neurotoxicity and late abnormal neurobehavioral functions as adults. Results from clinical studies have all been analyzed using existing data sets, and these studies produced inconsistent results. To provide more definitive evidence to address the clinical relevance of anesthetic neurotoxicity in children, an interdisciplinary team of investigators designed and developed the Pediatric Anesthesia NeuroDevelopment Assessment (PANDA) project. We present pilot study results in 28 sibling pairs recruited and tested at the Columbia University Medical Center (CUMC) and Children's Hospital of Boston (CHB) for the PANDA project. The PANDA project uses an ambidirectional cohort design. We performed prospective neuropsychological assessment in 28 exposed-unexposed sibling pairs from 6 to 11 years of age. The exposed siblings were ASA 1 or 2 and had received a single episode of anesthesia for inguinal hernia repair before the age of 36 months and the unexposed siblings had no anesthesia before the age of 36 months. All the sibling pairs were English speaking and were 36 weeks of gestational age or older. Each sibling pair underwent a direct testing using the Wechsler Abbreviated Scale of Intelligence (WASI) and the NEuroPSYchological Assessment, second edition (NEPSY II), and the parents completed questionnaires related to behavior using CBCL and Conners rating. Data are presented as means±SD. We conducted descriptive analyses of the demographic data. We compared both the exposed and the unexposed sibling groups on WASI and NEPSY II, and total and T scores from CBCL and Conners rating were analyzed as continuous data using the paired t test between the two groups. A P<0.05 was considered significant. After the Institutional Review Board approval for the study at both CUMC and CHB, the full PANDA study protocol was implemented to perform a pilot feasibility study. Our success rate was 96.7% in obtaining detailed medical and anesthesia records in our historical cohort. The scores for verbal IQ (exposed=106.1±16.3, unexposed=109.2±17.9), performance IQ (exposed=109.1±16.0, unexposed=113.9±15.9), and full IQ (exposed=108.2±14.0, unexposed=112.8±16.8) were comparable between the siblings. There were no differences between the two groups in T scores for any of the NEPSY II subdomains, CBCL, or Conners rating. An abstraction protocol with web-based electronic data capture forms also was developed in conjunction with the International Center for Health Outcomes and Innovation Research (InCHOIR). The pilot study provided useful information for feasibility to recruit the sample size and to obtain relevant clinical data. For the final study protocol, both the neuropsychological battery and the age range for testing were revised. Our results confirmed the feasibility of our study approach and yielded pilot data from neuropsychological testing.

Patient engagement with a mobile web-based telemonitoring system for heart failure self-management: a pilot study.

PubMed

Zan, Shiyi; Agboola, Stephen; Moore, Stephanie A; Parks, Kimberly A; Kvedar, Joseph C; Jethwani, Kamal

2015-04-01

Intensive remote monitoring programs for congestive heart failure have been successful in reducing costly readmissions, but may not be appropriate for all patients. There is an opportunity to leverage the increasing accessibility of mobile technologies and consumer-facing digital devices to empower patients in monitoring their own health outside of the hospital setting. The iGetBetter system, a secure Web- and telephone-based heart failure remote monitoring program, which leverages mobile technology and portable digital devices, offers a creative solution at lower cost. The objective of this pilot study was to evaluate the feasibility of using the iGetBetter system for disease self-management in patients with heart failure. This was a single-arm prospective study in which 21 ambulatory, adult heart failure patients used the intervention for heart failure self-management over a 90-day study period. Patients were instructed to take their weight, blood pressure, and heart rate measurements each morning using a WS-30 bluetooth weight scale, a self-inflating blood pressure cuff (Withings LLC, Issy les Moulineaux, France), and an iPad Mini tablet computer (Apple Inc, Cupertino, CA, USA) equipped with cellular Internet connectivity to view their measurements on the Internet. Outcomes assessed included usability and satisfaction, engagement with the intervention, hospital resource utilization, and heart failure-related quality of life. Descriptive statistics were used to summarize data, and matched controls identified from the electronic medical record were used as comparison for evaluating hospitalizations. There were 20 participants (mean age 53 years) that completed the study. Almost all participants (19/20, 95%) reported feeling more connected to their health care team and more confident in performing care plan activities, and 18/20 (90%) felt better prepared to start discussions about their health with their doctor. Although heart failure-related quality of life improved from baseline, it was not statistically significant (P=.55). Over half of the participants had greater than 80% (72/90 days) weekly and overall engagement with the program, and 15% (3/20) used the interactive voice response telephone system exclusively for managing their care plan. Hospital utilization did not differ in the intervention group compared to the control group (planned hospitalizations P=.23, and unplanned hospitalizations P=.99). Intervention participants recorded shorter average length of hospital stay, but no significant differences were observed between intervention and control groups (P=.30). This pilot study demonstrated the feasibility of a low-intensive remote monitoring program leveraging commonly used mobile and portable consumer devices in augmenting care for a fairly young population of ambulatory patients with heart failure. Further prospective studies with a larger sample size and within more diverse patient populations is necessary to determine the effect of mobile-based remote monitoring programs such as the iGetBetter system on clinical outcomes in heart failure.

A pilot prospective feasibility study of organ-at-risk definition using Target Contour Testing/Instructional Computer Software (TaCTICS), a training and evaluation platform for radiotherapy target delineation.

PubMed

Kalpathy-Cramer, Jayashree; Bedrick, Steven D; Boccia, Kelly; Fuller, Clifton D

2011-01-01

Target volume delineation is a critical, but time-consuming step in the creation of radiation therapy plans used in the treatment of many types of cancer. However, variability in target volume definitions can introduce substantial differences in resulting doses to tumors and critical structures. We developed TaCTICS, a web-based educational training software application targeted towards non-expert users. We report on a small, prospective study to evaluate the utility of this online tool in improving conformance of regions-of-interest (ROIs) with a reference set. Eight residents contoured a set of structures for a head-and-neck cancer case. Subsequently, they were provided access to TaCTICS as well as contouring atlases to allow evaluation of their contours in reference to other users as well as reference ROIs. The residents then contoured a second case using these resources. Volume overlap metrics between the users showed a substantial improvement following the intervention. Additionally, 66% of users reported that they found TaCTICS to be a useful educational tool and all participants reported they would like to use TaCTICS to track their contouring skills over the course of their residency.

How, When and Where to Discuss Do Not Resuscitate: A Prospective Study to Compare the Perceptions and Preferences of Patients, Caregivers, and Health Care Providers in a Multidisciplinary Lung Cancer Clinic.

PubMed

Ahmed, Naseer; Lobchuk, Michelle; Hunter, William M; Johnston, Pam; Nugent, Zoann; Sharma, Ankur; Ahmed, Shahida; Sisler, Jeff

2015-03-01

Do Not Resuscitate (DNR) is a significant but challenging part of end-of-life discussions when dealing with incurable lung cancer patients. We have explored the perceptions and preferences of patients, their caregivers (CGs), and health care providers (HCPs) and the current practice and opinions on DNR discussions in a multidisciplinary lung cancer clinic. This is a prospective descriptive study with a mixed quantitative and qualitative methodology to capture perceptions of the participants. To obtain a rich description of participant responses to questionnaire items, we employed a 'think aloud' process that prompted participants to immediately verbalize their thoughts when responding to questionnaire items. We used content analysis and constant comparison techniques to identify, code and categorize primary themes in the captured data. Ten patients with advanced-stage lung cancer; nine CGs from the lung clinic and ten HCPs from the Thoracic Disease Site Group (DSG) were enrolled in the study. Most patients had only a limited understanding of DNR. Most CGs had a fair to good understanding of DNR. Most HCPs perceived their patients to have understood DNR most of the time. When patients were interviewed, a theme of "anticipated discussion" about DNR was identified. Patients and CGs expressed having faith in the system and responsible physicians as to when to discuss DNR. HCPs embraced a clinician preference-based decision-making approach to engaging in DNR discussions. They desired more resources, more knowledge, more structure and more time to discuss DNR. Most HCPs felt that it would be worth conducting a prospective clinical trial to determine the best time to discuss DNR. This pilot study provides a unique mixed quantitative and qualitative understanding of the perceptions of patients with lung cancer and their CGs and HCPs regarding DNR discussion. Our findings will help further the development of evidence-based guidelines and a broad prospective study that would have important implications for policies and practices around DNR discussions in order to reduce the emotional pain of dying patients, their CGs and HCPs.

In-Flight Decision-Making by General Aviation Pilots Operating in Areas of Extreme Thunderstorms.

PubMed

Boyd, Douglas D

2017-12-01

General aviation (comprised mainly of noncommercial, light aircraft) accounts for 94% of civil aviation fatalities in the United States. Although thunderstorms are hazardous to light aircraft, little research has been undertaken on in-flight pilot decision-making regarding their avoidance. The study objectives were: 1) to determine if the thunderstorm accident rate has declined over the last two decades; and 2) assess in-flight (enroute/landing) airman decision-making regarding adherence to FAA separation minima from thunderstorms. Thunderstorm-related accidents were identified from the NTSB database. To determine en route/arriving aircraft real-time thunderstorm proximity/relative position and airplane location, using a flight-tracking (Flight Aware®) website, were overlaid on a graphical weather image. Statistics employed Poisson and Chi-squared analyses. The thunderstorm-related accident rate was undiminished over the 1996-2014 period. In a prospective analysis the majority (enroute 77%, landing 93%) of flights violated the FAA-recommended separation distance from extreme convection. Of these, 79 and 69% (en route and landing, respectively) selected a route downwind of the thunderstorm rather than a less hazardous upwind flight path. Using a mathematical product of binary (separation distance, relative aircraft-thunderstorm position) and nominal (thunderstorm-free egress area) parameters, airmen were more likely to operate in the thunderstorm hazard zone for landings than en route operations. The thunderstorm-related accident rate, carrying a 70% fatality rate, remains unabated, largely reflecting nonadherence to the FAA-recommended separation minima and selection of a more hazardous route (downwind) for circumnavigation of extreme convective weather. These findings argue for additional emphasis in ab initio pilot training/recurrency on thunderstorm hazards and safe practices (separation distance and flight path).Boyd DD. In-flight decision-making by general aviation pilots operating in areas of extreme thunderstorms. Aerosp Med Hum Perform. 2017; 88(12):1066-1072.

Successful Completion of the Pilot Phase of a Randomized Controlled Trial Comparing Sentinel Lymph Node Biopsy to No Further Axillary Staging in Patients with Clinical T1-T2 N0 Breast Cancer and Normal Axillary Ultrasound.

PubMed

Cyr, Amy E; Tucker, Natalia; Ademuyiwa, Foluso; Margenthaler, Julie A; Aft, Rebecca L; Eberlein, Timothy J; Appleton, Catherine M; Zoberi, Imran; Thomas, Maria A; Gao, Feng; Gillanders, William E

2016-08-01

Axillary surgery is not considered therapeutic in patients with clinical T1-T2 N0 breast cancer. The importance of axillary staging is eroding in an era in which tumor biology, as defined by biomarker and gene expression profile, is increasingly important in medical decision making. We hypothesized that axillary ultrasound (AUS) is a noninvasive alternative to sentinel lymph node biopsy (SLNB), and AUS could replace SLNB without compromising patient care. Patients with clinical T1-T2 N0 breast cancer and normal AUS were eligible for enrollment. Subjects were randomized to no further axillary staging (arm 1) vs SLNB (arm 2). Descriptive statistics were used to describe the results of the pilot phase of the randomized controlled trial. Sixty-eight subjects were enrolled in the pilot phase of the trial (34 subjects in arm 1, no further staging; 32 subjects in arm 2, SLNB; and 2 subjects voluntarily withdrew from the trial). The median age was 61 years (range 40 to 80 years) in arm 1 and 59 years (range 31 to 81 years) in arm 2, and there were no significant clinical or pathologic differences between the arms. Median follow-up was 17 months (range 1 to 32 months). The negative predictive value (NPV) of AUS for identification of clinically significant axillary disease (>2.0 mm) was 96.9%. No axillary recurrences have been observed in either arm. Successful completion of the pilot phase of the randomized controlled trial confirms the feasibility of the study design, and provides prospective evidence supporting the ability of AUS to exclude clinically significant disease in the axilla. The results provide strong support for a phase 2 randomized controlled trial. Copyright © 2016 American College of Surgeons. Published by Elsevier Inc. All rights reserved.

Simulation-based inter-professional education to improve attitudes towards collaborative practice: a prospective comparative pilot study in a Chinese medical centre

PubMed Central

Yang, Ling-Yu; Yang, Ying-Ying; Huang, Chia-Chang; Liang, Jen-Feng; Lee, Fa-Yauh; Cheng, Hao-Min; Huang, Chin-Chou; Kao, Shou-Yen

2017-01-01

Objectives Inter-professional education (IPE) builds inter-professional collaboration (IPC) attitude/skills of health professionals. This interventional IPE programme evaluates whether benchmarking sharing can successfully cultivate seed instructors responsible for improving their team members’ IPC attitudes. Design Prospective, pre-post comparative cross-sectional pilot study. Setting/participants Thirty four physicians, 30 nurses and 24 pharmacists, who volunteered to be trained as seed instructors participated in 3.5-hour preparation and 3.5-hour simulation courses. Then, participants (n=88) drew lots to decide 44 presenters, half of each profession, who needed to prepare IPC benchmarking and formed Group 1. The remaining participants formed Group 2 (regular). Facilitators rated the Group 1 participants’ degree of appropriate transfer and sustainable practice of the learnt IPC skills in the workplace according to successful IPC examples in their benchmarking sharing. Results For the three professions, improvement in IPC attitude was identified by sequential increase in the post-course (second month, T2) and end-of-study (third month, T3) Interdisciplinary Education Perception Scale (IEPS) and Attitudes Towards Healthcare Teams Scale (ATHCTS) scores, compared with pre-course (first month, T1) scores. By IEPS and ATHCTS-based assessment, the degree of sequential improvements in IPC attitude was found to be higher among nurses and pharmacists than in physicians. In benchmarking sharing, the facilitators’ agreement about the degree of participants’appropriate transfer and sustainable practice learnt ‘communication and teamwork’ skills in the workplace were significantly higher among pharmacists and nurses than among physicians. The post-intervention random sampling survey (sixth month, Tpost) found that the IPC attitude of the three professions improved after on-site IPC skill promotion by new programme-trained seed instructors within teams. Conclusions Addition of benchmark sharing to a diamond-based IPE simulation programme enhances participants’ IPC attitudes, self-reflection, workplace transfer and practice of the learnt skills. Furthermore, IPC promotion within teams by newly trained seed instructors improved the IPC attitudes across all three professions. PMID:29122781

A tutorial on pilot studies: the what, why and how

PubMed Central

2010-01-01

Pilot studies for phase III trials - which are comparative randomized trials designed to provide preliminary evidence on the clinical efficacy of a drug or intervention - are routinely performed in many clinical areas. Also commonly know as "feasibility" or "vanguard" studies, they are designed to assess the safety of treatment or interventions; to assess recruitment potential; to assess the feasibility of international collaboration or coordination for multicentre trials; to increase clinical experience with the study medication or intervention for the phase III trials. They are the best way to assess feasibility of a large, expensive full-scale study, and in fact are an almost essential pre-requisite. Conducting a pilot prior to the main study can enhance the likelihood of success of the main study and potentially help to avoid doomed main studies. The objective of this paper is to provide a detailed examination of the key aspects of pilot studies for phase III trials including: 1) the general reasons for conducting a pilot study; 2) the relationships between pilot studies, proof-of-concept studies, and adaptive designs; 3) the challenges of and misconceptions about pilot studies; 4) the criteria for evaluating the success of a pilot study; 5) frequently asked questions about pilot studies; 7) some ethical aspects related to pilot studies; and 8) some suggestions on how to report the results of pilot investigations using the CONSORT format. PMID:20053272

Vasovagal tonus index (VVTI) as an indirect assessment of remission status in canine multicentric lymphoma undergoing multi-drug chemotherapy.

PubMed

Pecceu, Evi; Stebbing, Brittainy; Martinez Pereira, Yolanda; Handel, Ian; Culshaw, Geoff; Hodgkiss-Geere, Hannah; Lawrence, Jessica

2017-12-01

Vasovagal tonus index (VVTI) is an indirect measure of heart rate variability and may serve as a marker of disease severity. Higher heart rate variability has predicted lower tumour burden and improved survival in humans with various tumour types. The purpose of this pilot study was to evaluate VVTI as a biomarker of remission status in canine lymphoma. The primary hypothesis was that VVTI would be increased in dogs in remission compared to dogs out of remission. Twenty-seven dogs were prospectively enrolled if they had a diagnosis of intermediate to high-grade lymphoma and underwent multidrug chemotherapy. Serial electrocardiogram data were collected under standard conditions and relationships between VVTI, remission status and other clinical variables were evaluated. VVTI from dogs in remission (partial or complete) did not differ from dogs with fulminant lymphoma (naive or at time of relapse). Dogs in partial remission had higher VVTI than dogs in complete remission (p = 0.021). Higher baseline VVTI was associated with higher subsequent scores (p < 0.001). VVTI also correlated with anxiety level (p = 0.03). Based on this pilot study, VVTI did not hold any obvious promise as a useful clinical biomarker of remission status. Further investigation may better elucidate the clinical and prognostic utility of VVTI in dogs with lymphoma.

Subacute effects of cervicothoracic spinal thrust/non-thrust in addition to shoulder manual therapy plus exercise intervention in individuals with subacromial impingement syndrome: a prospective, randomized controlled clinical trial pilot study.

PubMed

Wright, Alexis A; Donaldson, Megan; Wassinger, Craig A; Emerson-Kavchak, Alicia J

2017-09-01

To determine the subacute effects of cervicothoracic spinal thrust/non-thrust in addition to shoulder non-thrust plus exercise in patients with subacromial pathology. This was a randomized, single blinded controlled trial pilot study. This trial was registered at ClinicalTrials.gov (NCT01753271) and reported according to Consolidated Standards of Reporting Trials requirements. Patients were randomly assigned to either shoulder treatment plus cervicothoracic spinal thrust/non-thrust or shoulder treatment-only group. Primary outcomes were average pain intensity (Numeric Pain Rating Scale) and physical function (Shoulder Pain and Disability Index) at 2 weeks, 4 weeks, and patient discharge. 18 patients, mean age 43.1(15.8) years satisfied the eligibility criteria and were analyzed for follow-up data. Both groups showed statistically significant improvements in both pain and function at 2 weeks, 4 weeks, and discharge. The between-group differences for changes in pain or physical function were not significant at any time point. The addition of cervicothoracic spinal thrust/non-thrust to the shoulder treatment-only group did not significantly alter improvement in pain or function in patients with subacromial pathology. Both approaches appeared to provide an equally notable benefit. Both groups improved on all outcomes and met the criteria for clinical relevance for both pain and function. 2b.

Influence of preoperative life satisfaction on recovery and outcomes after colorectal cancer surgery - a prospective pilot study.

PubMed

Romain, B; Rohmer, O; Schimchowitsch, S; Hübner, M; Delhorme, J B; Brigand, C; Rohr, S; Guenot, D

2018-01-17

Colorectal surgery has an important impact on a patient's quality of life, and postoperative rehabilitation shows large variations. To enhance the understanding of recovery after colorectal cancer, health-related quality of life has become a standard outcome measurement for clinical care and research. Therefore, we aimed to correlate the influence of preoperative global life satisfaction on subjective feelings of well-being with clinical outcomes after colorectal surgery. In this pilot study of consecutive colorectal surgery patients, various dimensions of feelings of preoperative life satisfaction were assessed using a self-rated scale, which was validated in French. Both objective (length of stay and complications) and subjective (pain, subjective well-being and quality of sleep) indicators of recovery were evaluated daily during each patient's hospital stay. A total of 112 patients were included. The results showed a negative relationship between life satisfaction and postoperative complications and a significant negative correlation with the length of stay. Moreover, a significant positive correlation between life satisfaction and the combined subjective indicators of recovery was observed. We have shown the importance of positive preoperative mental states and global life satisfaction as characteristics that are associated with an improved recovery after colorectal surgery. Therefore, patients with a good level of life satisfaction may be better able to face the consequences of colorectal surgery, which is a relevant parameter in supportive cancer care.

Training opioid addiction treatment providers to adopt contingency management: A prospective pilot trial of a comprehensive implementation science approach.

PubMed

Becker, Sara J; Squires, Daniel D; Strong, David R; Barnett, Nancy P; Monti, Peter M; Petry, Nancy M

2016-01-01

Few prospective studies have evaluated theory-driven approaches to the implementation of evidence-based opioid treatment. This study compared the effectiveness of an implementation model (Science to Service Laboratory; SSL) to training as usual (TAU) in promoting the adoption of contingency management across a multisite opioid addiction treatment program. We also examined whether the SSL affected putative mediators of contingency management adoption (perceived innovation characteristics and organizational readiness to change). Sixty treatment providers (39 SSL, 21 TAU) from 15 geographically diverse satellite clinics (7 SSL, 8 TAU) participated in the 12-month study. Both conditions received didactic contingency management training and those in the predetermined experimental region received 9 months of SSL-enhanced training. Contingency management adoption was monitored biweekly, whereas putative mediators were measured at baseline, 3 months, and 12 months. Relative to providers in the TAU region, treatment providers in the SSL region had comparable likelihood of contingency management adoption in the first 20 weeks of the study, and then significantly higher likelihood of adoption (odds ratios = 2.4-13.5) for the remainder of the study. SSL providers also reported higher levels of one perceived innovation characteristic (Observability) and one aspect of organizational readiness to change (Adequacy of Training Resources), although there was no evidence that the SSL affected these putative mediators over time. Results of this study indicate that a fully powered randomized trial of the SSL is warranted. Considerations for a future evaluation are discussed.

Prospective surveillance pilot of rivaroxaban safety within the US Food and Drug Administration Sentinel System.

PubMed

Chrischilles, Elizabeth A; Gagne, Joshua J; Fireman, Bruce; Nelson, Jennifer; Toh, Sengwee; Shoaibi, Azadeh; Reichman, Marsha E; Wang, Shirley; Nguyen, Michael; Zhang, Rongmei; Izem, Rima; Goulding, Margie R; Southworth, Mary Ross; Graham, David J; Fuller, Candace; Katcoff, Hannah; Woodworth, Tiffany; Rogers, Catherine; Saliga, Ryan; Lin, Nancy D; McMahill-Walraven, Cheryl N; Nair, Vinit P; Haynes, Kevin; Carnahan, Ryan M

2018-03-01

The US Food and Drug Administration's Sentinel system developed tools for sequential surveillance. In patients with non-valvular atrial fibrillation, we sequentially compared outcomes for new users of rivaroxaban versus warfarin, employing propensity score matching and Cox regression. A total of 36 173 rivaroxaban and 79 520 warfarin initiators were variable-ratio matched within 2 monitoring periods. Statistically significant signals were observed for ischemic stroke (IS) (first period) and intracranial hemorrhage (ICH) (second period) favoring rivaroxaban, and gastrointestinal bleeding (GIB) (second period) favoring warfarin. In follow-up analyses using primary position diagnoses from inpatient encounters for increased definition specificity, the hazard ratios (HR) for rivaroxaban vs warfarin new users were 0.61 (0.47, 0.79) for IS, 1.47 (1.29, 1.67) for GIB, and 0.71 (0.50, 1.01) for ICH. For GIB, the HR varied by age: <66 HR = 0.88 (0.60, 1.30) and 66+ HR = 1.49 (1.30, 1.71). This study demonstrates the capability of Sentinel to conduct prospective safety monitoring and raises no new concerns about rivaroxaban safety. Copyright © 2018 John Wiley & Sons, Ltd.

Hydroxyurea therapy in adult Nigerian sickle cell disease: a monocentric survey on pattern of use, clinical effects and patient's compliance.

PubMed

Adewoyin, Ademola Samson; Oghuvwu, Omokiniovo Sunday; Awodu, Omolade Augustina

2017-03-01

The clinical prospects of hydroxyurea therapy in the management of sickle cell disease (SCD) require evaluation in the Nigerian setting to develop indigenous guidelines. This survey examines the pattern of hydroxyurea therapy, its clinico-haematologic benefits and safety profile in Nigerian SCD subjects. A cross sectional pilot survey was carried out among 60 adult SCD subjects over 3 months. Data on clinical phenotypes, relevant haematological parameters and details of hydroxyurea therapy were obtained using a structured questionnaire through an interview process and case file review. The median age was 30 years. Thirty-four (56.7%) of the subjects are aware of hydroxyurea therapy in SCD. Twenty-four (40%) SCD patients had previously used hydroxyurea. Only 4 subjects were fully compliant. Reasons for non-compliance included poor knowledge and lack of funds. In particular, hydroxyurea reduced leucocyte count and increased mean red cell volume (MCV) in compliant subjects. Hydroxyurea use is low among Nigerian SCD subjects despite its proven efficacy/clinical prospects in the developed nations. Large scale multicenter studies and clinical trials are needed to form a basis for developing standard local treatment protocol for its use.

Predict the Medicare Functional Classification Level (K-level) using the Amputee Mobility Predictor in people with unilateral transfemoral and transtibial amputation: A pilot study.

PubMed

Dillon, Michael P; Major, Matthew J; Kaluf, Brian; Balasanov, Yuri; Fatone, Stefania

2018-04-01

While Amputee Mobility Predictor scores differ between Medicare Functional Classification Levels (K-level), this does not demonstrate that the Amputee Mobility Predictor can accurately predict K-level. To determine how accurately K-level could be predicted using the Amputee Mobility Predictor in combination with patient characteristics for persons with transtibial and transfemoral amputation. Prediction. A cumulative odds ordinal logistic regression was built to determine the effect that the Amputee Mobility Predictor, in combination with patient characteristics, had on the odds of being assigned to a particular K-level in 198 people with transtibial or transfemoral amputation. For people assigned to the K2 or K3 level by their clinician, the Amputee Mobility Predictor predicted the clinician-assigned K-level more than 80% of the time. For people assigned to the K1 or K4 level by their clinician, the prediction of clinician-assigned K-level was less accurate. The odds of being in a higher K-level improved with younger age and transfemoral amputation. Ordinal logistic regression can be used to predict the odds of being assigned to a particular K-level using the Amputee Mobility Predictor and patient characteristics. This pilot study highlighted critical method design issues, such as potential predictor variables and sample size requirements for future prospective research. Clinical relevance This pilot study demonstrated that the odds of being assigned a particular K-level could be predicted using the Amputee Mobility Predictor score and patient characteristics. While the model seemed sufficiently accurate to predict clinician assignment to the K2 or K3 level, further work is needed in larger and more representative samples, particularly for people with low (K1) and high (K4) levels of mobility, to be confident in the model's predictive value prior to use in clinical practice.

Increasing Performance of Professional Soccer Players and Elite Track and Field Athletes with Peak Performance Training and Biofeedback: A Pilot Study.

PubMed

Rijken, Noortje H; Soer, Remko; de Maar, Ewold; Prins, Hilco; Teeuw, Wouter B; Peuscher, Jan; Oosterveld, Frits G J

2016-12-01

The aim of this pilot study was to investigate the effects of an intervention consisting of mental coaching combined with either electro encephalogram (EEG) alpha power feedback or heart rate variability (HRV) feedback on HRV, EEG outcomes and self-reported factors related to stress, performance, recovery and sleep quality in elite athletes. A prospective pilot study was performed with two distinct cohorts. Soccer players were provided with four sessions of mental coaching combined with daily HRV biofeedback (Group A); track and field athletes were provided with four sessions of mental coaching in combination with daily neurofeedback (Group B). Measurements were performed at baseline, post intervention and at 5 weeks follow-up. Objective measures: EEG and ECG. Subjective measures: Numeric Rating Scale for performance, Pittsburgh Sleep Quality Index, Rest and Stress Questionnaire and Sports Improvement-60. Group characteristics were too distinct to compare the interventions. Linear mixed models were used to analyze differences within groups over time. In Group A, significant changes over time were present in alpha power at 5 of 7 EEG locations (p < 0.01-0.03). LF/HF ratio significantly increased (p = 0.02) and the concentration (p = 0.02) and emotional scale (p = 0.03) of the SIM-60 increased significantly (p = 0.04). In Group B, the HRV low frequency power and recovery scale of the REST-Q significantly increased (p = 0.02 and <0.01 resp.). Other measures remained stable or improved non-significantly. A mental coaching program combined with either HRV or EEG alpha power feedback may increase HRV and alpha power and may lead to better performance-related outcomes and stress reduction. Further research is needed to elucidate the effects of either type of feedback and to compare effects with a control group.

Alfaxalone versus alfaxalone-dexmedetomidine anaesthesia by immersion in oriental fire-bellied toads (Bombina orientalis).

PubMed

Adami, Chiara; d'Ovidio, Dario; Casoni, Daniela

2016-05-01

To determine a dexmedetomidine concentration, to be added to an alfaxalone-based bath solution, that will enhance the anaesthetic and analgesic effects of alfaxalone; and to compare the quality of anaesthesia and analgesia provided by immersion with either alfaxalone alone or alfaxalone with dexmedetomidine in oriental fire-bellied toads (Bombina orientalis). Pilot study followed by a prospective, randomized, experimental trial. Fourteen oriental fire-bellied toads. The pilot study aimed to identify a useful dexmedetomidine concentration to be added to an anaesthetic bath containing 20 mg 100 mL(-1) alfaxalone. Thereafter, the toads were assigned to one of two groups, each comprising eight animals, to be administered either alfaxalone (group A) or alfaxalone-dexmedetomidine (group AD). After immersion for 20 minutes, the toads were removed from the anaesthetic bath and the righting, myotactic and nociceptive reflexes, cardiopulmonary variables and von Frey filaments threshold were measured at 5 minute intervals and compared statistically between groups. Side effects and complications were noted and recorded. In the pilot study, a dexmedetomidine concentration of 0.3 mg 100 mL(-1) added to the alfaxalone-based solution resulted in surgical anaesthesia. The toads in group AD showed higher von Frey thresholds and lower nociceptive withdrawal reflex scores than those in group A. However, in group AD, surgical anaesthesia was observed in two out of eight toads only, and induction of anaesthesia was achieved in only 50% of the animals, as compared with 100% of the toads in group A. The addition of dexmedetomidine to an alfaxalone-based solution for immersion anaesthesia provided some analgesia in oriental fire-bellied toads, but failed to potentiate the level of unconsciousness and appeared to lighten the depth of anaesthesia. This limitation renders the combination unsuitable for anaesthetizing oriental fire-bellied toads for invasive procedures. © 2015 Association of Veterinary Anaesthetists and the American College of Veterinary Anesthesia and Analgesia.

Prospective Randomized Trial of Use of In-House Prepared Low-Cost Radiopharmaceutical Versus Commercial Radiopharmaceutical for Sentinel Lymph Node Biopsy in Patients with Early Stage Invasive Breast Cancer.

PubMed

Agarwal, Gaurav; Rajan, Sendhil; Mayilvaganan, Sabaretnam; Mishra, Anjali; Krishnani, Narendra; Gambhir, Sanjay

2018-05-01

The current standard-of-care for surgical staging of the axilla in clinically node-negative (N0) early breast cancers is sentinel lymph node biopsy (SLNB), which requires expensive radiopharmaceuticals for efficacious results. In-house produced low-cost radiopharmaceuticals may be the solution and have shown efficacy in earlier observational/pilot studies. We compared SLNB using in-house prepared radiopharmaceutical ( 99m Tc-Antimony-colloid) versus commercially marketed radiopharmaceutical ( 99m Tc-Sulphur-colloid) in this prospective randomized study. 78 clinically N0 early breast cancer patients (T1/2, N0 stages), undergoing primary surgery were prospectively randomized 1:1 into two groups; to receive SLNB using methylene blue, and either 99m Tc-Antimony colloid (Group-1) or   99m Tc-Sulphur colloid (Group-2). Completion axillary dissection was done in all (validation SLNB). SLNB indices were compared between the groups. The groups were comparable with regard to age, stage, tumour size, hormone receptors and HER2neu status. Cost of the in-house prepared 99m Tc-antimony colloid was 16-times lesser compared to 99m Tc-sulphur colloid. SLN identification rates (IR) in Groups 1 and 2 were 100 and 97.4% respectively, (p > 0.05). False negative rates (FNR) in Group 1 and 2 were 6.3% (1/16 patients) and 7.7% (1/13 patients), respectively, (p > 0.05). There were no major allergic reactions in either group. In this prospective randomized trial on early breast cancer patients, accuracy of SLNB was comparable using in-house prepared, 99m Tc-antimony colloid and commercially marketed 99m Tc-sulphur colloid as radiopharmaceutical, while 99m Tc-antimony colloid was much cheaper than 99m Tc-sulphur colloid.

High-Resolution Scintimammography: A Pilot Study

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

Rachel F. Brem; Joelle M. Schoonjans; Douglas A. Kieper

2002-07-01

This study evaluated a novel high-resolution breast-specific gamma camera (HRBGC) for the detection of suggestive breast lesions. Methods: Fifty patients (with 58 breast lesions) for whom a scintimammogram was clinically indicated were prospectively evaluated with a general-purpose gamma camera and a novel HRBGC prototype. The results of conventional and high-resolution nuclear studies were prospectively classified as negative (normal or benign) or positive (suggestive or malignant) by 2 radiologists who were unaware of the mammographic and histologic results. All of the included lesions were confirmed by pathology. Results: There were 30 benign and 28 malignant lesions. The sensitivity for detection ofmore » breast cancer was 64.3% (18/28) with the conventional camera and 78.6% (22/28) with the HRBGC. The specificity with both systems was 93.3% (28/30). For the 18 nonpalpable lesions, sensitivity was 55.5% (10/18) and 72.2% (13/18) with the general-purpose camera and the HRBGC, respectively. For lesions 1 cm, 7 of 15 were detected with the general-purpose camera and 10 of 15 with the HRBGC. Four lesions (median size, 8.5 mm) were detected only with the HRBGC and were missed by the conventional camera. Conclusion: Evaluation of indeterminate breast lesions with an HRBGC results in improved sensitivity for the detection of cancer, with greater improvement shown for nonpalpable and 1-cm lesions.« less

Psychological predictors of outcome in vertical banded gastroplasty: a 6 months prospective pilot study.

PubMed

Leombruni, Paolo; Pierò, Andrea; Dosio, Davide; Novelli, Alessia; Abbate-Daga, Giovanni; Morino, Mario; Toppino, Mauro; Fassino, Secondo

2007-07-01

At present, bariatric surgery is the most effective treatment for morbid obesity. Several factors appear to influence the patient's ability to adjust to the postoperative condition, but reliable predictors are lacking. The aim of this study was to assess whether psychological presurgical variables can predict outcome of vertical banded gastroplasty (VBG) in the short term. 38 severely obese patients (6 men and 32 women) underwent laparoscopic VBG. All were assessed prospectively at TO (before surgery) and at T6 (6 months after surgery) with a semi-structured interview and a battery of psychological tests: State Trait Anger Expression Inventory (STAXI), Eating Disorder Inventory (EDI-2), Symptom Checklist 90 (SCL-90), Beck Depression Inventory (BDI), Binge Eating Scale (BES), Body Shape Questionnaire (BSQ), and (only at TO) the Temperament and Character Inventory (TCI). The comparison between TO and T6 found a significant weight loss and an improvement in several dimensions of EDI-2, BDI, and BSQ, together with an increase in the frequency of vomiting. Self-directedness (TCI) and Body Dissatisfaction (EDI-2) appear to be predictors of short-term outcome regarding weight loss. Self-transcendence (TCI) is associated with emerging side-effects. Although larger and longer studies are necessary to confirm these data, Self directedness and Self trascendence emerge as predictors of 6 months clinical and psychological outcome of VBG.

The association between maternal hydronephrosis and acute flank pain during pregnancy: a prospective pilot-study.

PubMed

Farr, Alex; Ott, Johannes; Kueronya, Verena; Margreiter, Markus; Javadli, Elchin; Einig, Sabrina; Husslein, Peter W; Bancher-Todesca, Dagmar

2017-10-01

Maternal hydronephrosis may cause flank pain during pregnancy. We aimed to investigate the association between maternal hydronephrosis and flank pain intensity. From 2014 to 2015, all consecutive women with singleton pregnancies, who presented at our tertiary center due to acute flank pain, were prospectively evaluated by renal ultrasonography and pain questionnaires. A visual analogue scale was used to assess pain intensity. The study had 90% power to detect a significant correlation between hydronephrosis and flank pain (Spearman's test). A total of 51 consecutive women with left-sided (13.7%), right-sided (64.7%) or bilateral (21.6%) pain were enrolled. The mean gestational age of these women, who presented due to their pain, was 27.5 ± 6.8 weeks at the time of consultation. The mean VAS score was 7.6 ± 2.2. In 43/51 (84.3%) women, hydronephrosis was found on renal sonograms. No correlation was found between the grade of hydronephrosis and pain intensity (p = 0.466; r= -0.28). Women delivered at a mean gestational age of 38.1 ± 2.4 weeks and their infants had a mean birthweight of 3138 ± 677 g. Hydronephrosis is a common finding among pregnant women with acute flank pain. The grade of hydronephrosis does not affect pain intensity. This study suggests normal pregnancy outcomes in these women.

Double-blind, placebo-controlled pilot study of adjunctive quetiapine SR in the treatment of PMS/PMDD.

PubMed

Jackson, Christine; Pearson, Brenda; Girdler, Susan; Johnson, Jacqueline; Hamer, Robert M; Killenberg, Susan; Meltzer-Brody, Samantha

2015-11-01

Premenstrual dysphoric disorder (PMDD), a more severe form of premenstrual syndrome (PMS), afflicts 5-8% of reproductive age women and results in significant functional impairment. We conducted a double-blind, placebo-controlled trial of adjunctive quetiapine in patients with PMS/PMDD who had inadequate response to selective serotonin reuptake inhibitor/serotonin-norepinephrine reuptake inhibitor therapy for their symptoms. A PMS/PMDD diagnosis was confirmed by 2-month prospective diagnostic assessment of PMS/PMDD using the Prospective Record of the Impact and Severity of Premenstrual Symptoms (PRISM) calendar. Women were randomized equally to receive quetiapine sustained-release (SR) or placebo (25-mg starting dose) during the luteal phase for 3 months. Outcome variables included the Hamilton Depression and Anxiety Scales, Clinical Global Impression Scale, and PRISM. Twenty women were enrolled in the treatment phase. Although the study was underpowered, greater reductions in luteal phase mood ratings were observed in the quetiapine group on the 17-item Hamilton Depression Rating Scale, Clinical Global Impression improvement rating, and PRISM daily score. The quetiapine group showed most improvement in symptoms of mood lability, anxiety, and irritability. This small double-blind study suggests that adjunctive treatment with quetiapine SR may be a useful addition to selective serotonin reuptake inhibitor therapy in women with PMS/PMDD by reducing symptoms and improving quality of life. Copyright © 2015 John Wiley & Sons, Ltd.

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

PubMed Central

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

2013-01-01

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

Prospective study of rabbit antithymocyte globulin and cyclosporine for aplastic anemia from the EBMT Severe Aplastic Anaemia Working Party.

PubMed

Marsh, Judith C; Bacigalupo, Andrea; Schrezenmeier, Hubert; Tichelli, Andre; Risitano, Antonio M; Passweg, Jakob R; Killick, Sally B; Warren, Alan J; Foukaneli, Theodora; Aljurf, Mahmoud; Al-Zahrani, H A; Höchsmann, Britta; Schafhausen, Philip; Roth, Alexander; Franzke, Anke; Brummendorf, Tim H; Dufour, Carlo; Oneto, Rosi; Sedgwick, Philip; Barrois, Alain; Kordasti, Shahram; Elebute, Modupe O; Mufti, Ghulam J; Socie, Gerard

2012-06-07

Rabbit antithymocyte globulin (rATG; thymoglobulin, Genzyme) in combination with cyclosporine, as first-line immunosuppressive therapy, was evaluated prospectively in a multicenter, European, phase 2 pilot study, in 35 patients with aplastic anemia. Results were compared with 105 age- and disease severity-matched patients from the European Blood and Marrow Transplant registry, treated with horse ATG (hATG; lymphoglobulin) and cyclosporine. The primary end point was response at 6 months. At 3 months, no patients had achieved a complete response to rATG. Partial response occurred in 11 (34%). At 6 months, complete response rate was 3% and partial response rate 37%. There were 10 deaths after rATG (28.5%) and 1 after subsequent HSCT. Infections were the main cause of death in 9 of 10 patients. The best response rate was 60% for rATG and 67% for hATG. For rATG, overall survival at 2 years was 68%, compared with 86% for hATG (P = .009). Transplant-free survival was 52% for rATG and 76% for hATG (P = .002). On multivariate analysis, rATG (hazard ratio = 3.9, P = .003) and age more than 37 years (hazard ratio = 4.7, P = .0008) were independent adverse risk factors for survival. This study was registered at www.clinicaltrials.gov as NCT00471848.

Contribution to More Patient-Friendly ART Treatment: Efficacy of Continuous Low-Dose GnRH Agonist as the Only Luteal Support—Results of a Prospective, Randomized, Comparative Study

PubMed Central

Pirard, Céline; Loumaye, Ernest; Wyns, Christine

2015-01-01

Background. The aim of this pilot study was to evaluate intranasal buserelin for luteal phase support and compare its efficacy with standard vaginal progesterone in IVF/ICSI antagonist cycles. Methods. This is a prospective, randomized, open, parallel group study. Forty patients underwent ovarian hyperstimulation with human menopausal gonadotropin under pituitary inhibition with gonadotropin-releasing hormone antagonist, while ovulation trigger and luteal support were achieved using intranasal GnRH agonist (group A). Twenty patients had their cycle downregulated with buserelin and stimulated with hMG, while ovulation trigger was achieved using 10,000 IU human chorionic gonadotropin with luteal support by intravaginal progesterone (group B). Results. No difference was observed in estradiol levels. Progesterone levels on day 5 were significantly lower in group A. However, significantly higher levels of luteinizing hormone were observed in group A during the entire luteal phase. Pregnancy rates (31.4% versus 22.2%), implantation rates (22% versus 15.4%), and clinical pregnancy rates (25.7% versus 16.7%) were not statistically different between groups, although a trend towards higher rates was observed in group A. No luteal phase lasting less than 10 days was recorded in either group. Conclusion. Intranasal administration of buserelin is effective for providing luteal phase support in IVF/ICSI antagonist protocols. PMID:25945092

A Pilot Study of a Novel Automated Somatosensory Evoked Potential (SSEP) Monitoring Device for Detection and Prevention of Intraoperative Peripheral Nerve Injury in Total Shoulder Arthroplasty Surgery.

PubMed

Chui, Jason; Murkin, John M; Drosdowech, Darren

2018-05-21

Peripheral nerve injury is a potentially devastating complication after total shoulder arthroplasty (TSA) surgery. This pilot study aimed to assess the feasibility of using an automated somatosensory evoked potential (SSEP) device to provide a timely alert/intervention to minimize intraoperative nerve insults during TSA surgery. A prospective, single-arm, observational study was conducted in a single university hospital. The attending anesthesiologist monitored the study participants using the EPAD automated SSEP device and an intervention was made if there was an alert during TSA surgery. The median, radial, and ulnar nerve SSEP on the operative arm, as well as the median nerve SSEP of the nonoperative arm were monitored for each patient. All patients were evaluated for postoperative neurological deficits 6 weeks postoperatively. In total, 21 patients were consented and were successfully monitored. In total, 4 (19%) patients developed intraoperative abnormal SSEP signal changes in the operative arm, in which 3 were reversible and 1 was irreversible till the end of surgery. Median and radial nerves were mostly involved (3/4 patients). The mean cumulative duration of nerve insult (abnormal SSEP) was 21.7±26.2 minutes. Univariate analysis did not identify predictor of intraoperative nerve insults. No patients demonstrated postoperative peripheral neuropathy at 6 weeks. A high incidence (19%) of intraoperative nerve insult was observed in this study demonstrating the feasibility of using an automated SSEP device to provide a timely alert and enable an intervention in order to minimize peripheral nerve injury during TSA. Further randomized studies are warranted.

Why undertake a pilot in a qualitative PhD study? Lessons learned to promote success.

PubMed

Wray, Jane; Archibong, Uduak; Walton, Sean

2017-01-23

Background Pilot studies can play an important role in qualitative studies. Methodological and practical issues can be shaped and refined by undertaking pilots. Personal development and researchers' competence are enhanced and lessons learned can inform the development and quality of the main study. However, pilot studies are rarely published, despite their potential to improve knowledge and understanding of the research. Aim To present the main lessons learned from undertaking a pilot in a qualitative PhD study. Discussion This paper draws together lessons learned when undertaking a pilot as part of a qualitative research project. Important methodological and practical issues identified during the pilot study are discussed including access, recruitment, data collection and the personal development of the researcher. The resulting changes to the final study are also highlighted. Conclusion Sharing experiences of and lessons learned in a pilot study enhances personal development, improves researchers' confidence and competence, and contributes to the understanding of research. Implications for practice Pilots can be used effectively in qualitative studies to refine the final design, and provide the researcher with practical experience to enhance confidence and competence.

Interdisciplinary development and implementation of communication checklist for postoperative management of pediatric airway patients.

PubMed

Kim, Sang W; Maturo, Stephen; Dwyer, Danielle; Monash, Bradley; Yager, Phoebe H; Zanger, Kerstin; Hartnick, Christopher J

2012-01-01

The authors describe their multidisciplinary experience in applying the Institute of Health Improvement methodology to develop a protocol and checklist to reduce communication error during transfer of care for postoperative pediatric surgical airway patients. Preliminary outcome data following implementation of the protocol and checklist are also presented. Prospective study from July 1, 2009, to February 1, 2011. Tertiary care center. Subjects. One hundred twenty-six pediatric airway patients who required coordinated care between Massachusetts Eye and Ear Infirmary and Massachusetts General Hospital. Two sentinel events involving airway emergencies demonstrated a critical need for a standardized, comprehensive instrument that would ensure safe transfer of care. After development and implementation of the protocol and checklist, an initial pilot period on the first set of 9 pediatric airway patients was reassessed. Subsequent prospective 11-month follow-up data of 93 pediatric airway patients were collected and analyzed. A multidisciplinary pediatric team developed and implemented a formalized, postoperative checklist and transfer protocol. After implementation of the checklist and transfer protocol, prospective analysis showed no adverse events from miscommunication during transfer of care over the subsequent 11-month period involving 93 pediatric airway patients. There has been very little written in the quality and safety patient literature about coordinating effective transfer of care between the pediatric surgical and medical subspecialty realms. After design and implementation of a simple, electronically based transfer-of-care checklist and protocol, the number of postsurgical pediatric airway information transfer and communication errors decreased significantly.

Mental disorder in children with physical conditions: a pilot study.

PubMed

Butler, Alexandra; Van Lieshout, Ryan J; Lipman, Ellen Louise; MacMillan, Harriet L; Gonzalez, Andrea; Gorter, Jan Willem; Georgiades, Kathy; Speechley, Kathy N; Boyle, Michael H; Ferro, Mark A

2018-01-03

Methodologically, to assess the feasibility of participant recruitment and retention, as well as missing data in studying mental disorder among children newly diagnosed with chronic physical conditions (ie, multimorbidity). Substantively, to examine the prevalence of multimorbidity, identify sociodemographic correlates and model the influence of multimorbidity on changes in child quality of life and parental psychosocial outcomes over a 6-month follow-up. Prospective pilot study. Two children's tertiary-care hospitals. Children aged 6-16 years diagnosed in the past 6 months with one of the following: asthma, diabetes, epilepsy, food allergy or juvenile arthritis, and their parents. Response, participation and retention rates. Child mental disorder using the Mini International Neuropsychiatric Interview at baseline and 6 months. Child quality of life, parental symptoms of stress, anxiety and depression, and family functioning. All outcomes were parent reported. Response, participation and retention rates were 90%, 83% and 88%, respectively. Of the 50 children enrolled in the study, the prevalence of multimorbidity was 58% at baseline and 42% at 6 months. No sociodemographic characteristics were associated with multimorbidity. Multimorbidity at baseline was associated with declines over 6 months in the following quality of life domains: physical well-being, β=-4.82 (-8.47, -1.17); psychological well-being, β=-4.10 (-7.62, -0.58) and school environment, β=-4.17 (-8.18, -0.16). There was no association with parental psychosocial outcomes over time. Preliminary evidence suggests that mental disorder in children with a physical condition is very common and has a negative impact on quality of life over time. Based on the strong response rate and minimal attrition, our approach to study child multimorbidity appears feasible and suggests that multimorbidity is an important concern for families. Methodological and substantive findings from this pilot study have been used to implement a larger, more definitive study of child multimorbidity, which should lead to important clinical implications. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

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

PubMed Central

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

2017-01-01

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

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

PubMed Central

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

2015-01-01

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

Early intervention following trauma may mitigate genetic risk for PTSD in civilians: a pilot prospective emergency department study.

PubMed

Rothbaum, Barbara O; Kearns, Megan C; Reiser, Emily; Davis, Jennifer S; Kerley, Kimberly A; Rothbaum, Alex O; Mercer, Kristina B; Price, Matthew; Houry, Debra; Ressler, Kerry J

2014-12-01

Civilian posttraumatic stress disorder (PTSD) and combat PTSD are major public health concerns. Although a number of psychosocial risk factors have been identified related to PTSD risk, there are no accepted, robust biological predictors that identify who will develop PTSD or who will respond to early intervention following trauma. We wished to examine whether genetic risk for PTSD can be mitigated with an early intervention. 65 emergency department patients recruited in 2009-2010 at Grady Memorial Hospital in Atlanta, Georgia, who met criterion A of DSM-IV PTSD received either 3 sessions of an exposure intervention, beginning in the emergency department shortly after trauma exposure or assessment only. PTSD symptoms were assessed 4 and 12 weeks after trauma exposure. A composite additive risk score was derived from polymorphisms in 10 previously identified genes associated with stress-response (ADCYAP1R1, COMT, CRHR1, DBH, DRD2, FAAH, FKBP5, NPY, NTRK2, and PCLO), and gene x treatment effects were examined. The intervention included 3 sessions of imaginal exposure to the trauma memory and additional exposure homework. The primary outcome measure was the PTSD Symptom Scale-Interview Version or DSM-IV-based PTSD diagnosis in patients related to genotype and treatment group. A gene x intervention x time effect was detected for individual polymorphisms, in particular the PACAP receptor, ADCYAP1R1, as well as with a combined genotype risk score created from independent SNP markers. Subjects who did not receive treatment had higher symptoms than those who received intervention. Furthermore, subjects with the "risk" genotypes who did not receive intervention had higher PTSD symptoms compared to those with the "low-risk" or "resilience" genotypes or those who received intervention. Additionally, PTSD symptoms correlated with level of genetic risk at week 12 (P < .005) in the assessment-only group, but with no relationship in the intervention group, even after controlling for age, sex, race, education, income, and childhood trauma. Using logistic regression, the number of risk alleles was significantly associated with likelihood of PTSD diagnosis at week 12 (P < .05). This pilot prospective study suggests that combined genetic variants may serve to predict those most at risk for developing PTSD following trauma. A psychotherapeutic intervention initiated in the emergency department within hours of the trauma may mitigate this risk. The role of genetic predictors of risk and resilience should be further evaluated in larger, prospective intervention and prevention trials. ClinicalTrials.gov identifier: NCT00895518. © Copyright 2014 Physicians Postgraduate Press, Inc.

Comparison of routine and unprepped CT colonography augmented by low fiber diet and stool tagging: a pilot study.

PubMed

Dachman, Abraham H; Dawson, Damien O; Lefere, Philippe; Yoshida, Hiro; Khan, Nasreen U; Cipriani, Nicole; Rubin, David T

2007-01-01

We performed a pilot study examining the feasibility of a new unprepped CT colonography (CTC) strategy: low fiber diet and tagging (unprepped) vs. low fiber diet, tagging and a magnesium citrate cleansing preparation (prepped). Prior reports of tagging were limited in that the residual stool was neither measured and stratified by size nor did prior reports subjectively evaluate the ease of interpretation by a reader experienced in interpreting CTC examinations. Prospective randomized to unprepped n = 14 and prepped n = 14. Colonic segments were subjectively evaluated for residual stool that would potentially interfere with interpretation. Scores were given in the following categories: percentage of residual stool that was touching or nearly touching mucosa, the largest piece of retained stool, effectiveness of tagging, height of residual fluid, degree of distention, ease of interpretation, and reading time. Ease of the CT read (scale where 4 = optimal read) averaged 1.3 for the unprepped group and 2.3 for the prepped group. The mean read time averaged 17.5 min for unprepped and 17.9 min for prepped. The degree of distention (scale where 4 = well distended) averaged 3.7 for unprepped and 3.6 for prepped. Supine and prone images combined, the unprepped group had 160 segments with stool; prepped group had 58 segments. The amount of stool covering the mucosa in all segments averaged 1.6 (33%-66% coverage) in the unprepped group and 0.35 (<33% mucosal coverage) in the prepped group. The mean size of the largest piece of stool was 33.67 mm for unprepped and 4.01 mm for prepped. Percentage of tagged stool was not significantly different between the groups (range of 94-98%). The height of residual fluid averaged 8.37 mm for unprepped and 13.4 mm for prepped. Three polyps in three patients were found during optical colonoscopy (OC) in the unprepped group (5, 6, and 10 mm), none of which were prospectively detected at CTC. Three polyps in three patients were detected during OC in the prepped group (5, 10, and 15 mm), two of which were prospectively detected at CTC. Two false-positive lesions were observed at CTC in one patient in the prepped group. There was more stool in the unprepped group and while this factor did not slow down the reading time, it made the examination subjectively harder to interpret and likely caused the three polyps in this group to be missed. We conclude that a truly unprepped strategy that leaves significant residual stool, even if well tagged, is not desirable.

Prospective cohort studies of newly marketed medications: using covariate data to inform the design of large-scale studies.

PubMed

Franklin, Jessica M; Rassen, Jeremy A; Bartels, Dorothee B; Schneeweiss, Sebastian

2014-01-01

Nonrandomized safety and effectiveness studies are often initiated immediately after the approval of a new medication, but patients prescribed the new medication during this period may be substantially different from those receiving an existing comparator treatment. Restricting the study to comparable patients after data have been collected is inefficient in prospective studies with primary collection of outcomes. We discuss design and methods for evaluating covariate data to assess the comparability of treatment groups, identify patient subgroups that are not comparable, and decide when to transition to a large-scale comparative study. We demonstrate methods in an example study comparing Cox-2 inhibitors during their postmarketing period (1999-2005) with nonselective nonsteroidal anti-inflammatory drugs (NSAIDs). Graphical checks of propensity score distributions in each treatment group showed substantial problems with overlap in the initial cohorts. In the first half of 1999, >40% of patients were in the region of nonoverlap on the propensity score, and across the study period this fraction never dropped below 10% (the a priori decision threshold for transitioning to the large-scale study). After restricting to patients with no prior NSAID use, <1% of patients were in the region of nonoverlap, indicating that a large-scale study could be initiated in this subgroup and few patients would need to be trimmed from analysis. A sequential study design that uses pilot data to evaluate treatment selection can guide the efficient design of large-scale outcome studies with primary data collection by focusing on comparable patients.

Implementation of enhanced recovery programme after pancreatoduodenectomy: a single-centre UK pilot study.

PubMed

Abu Hilal, Mohammed; Di Fabio, Francesco; Badran, Abdallah; Alsaati, Hani; Clarke, Hannah; Fecher, Imogen; Armstrong, Thomas H; Johnson, Colin D; Pearce, Neil W

2013-01-01

Data on enhanced recovery programmes after pancreatoduodenectomy (ERP-PD) is limited. The aim of this pilot study was to evaluate the feasibility, safety and clinical outcomes of ERP-PD when implemented at a high-volume UK university referral centre. This was an observational single-surgeon case-control study (before-and-after pathway). A total of 20 consecutive patients were prospectively enrolled for the ERP-PD and compared with 24 consecutive patients previously treated during an equal time frame. Patients in the ERP-PD group had a significant shorter time to remove naso-gastric tube (median of 5 vs. 7 days, p = 0.0001), start liquid diet (median of 2 vs. 5 days, p < 0.0001), start solid food (median of 4 vs. 9 days, p < 0.0001), pass stools (median of 6 vs. 7 days, p = 0.002), and had shorter length of stay (median of 8.5 days vs. 13 days, p = 0.015) compared to the pre-pathway group. Postoperative complications were overall less frequent but not significantly different in the ERP-PD group (p = 0.077). No difference in mortality and readmission rates was found. Our findings support the feasibility and safety of ERP-PD. Improved patients' outcomes, significant bed day savings and increase National Health Service productivity are anticipated with implementation of ERP-PD on a larger scale. Copyright © 2012 IAP and EPC. Published by Elsevier B.V. All rights reserved.

Efficacy of Epidural Perineural Injection of Autologous Conditioned Serum in Unilateral Cervical Radiculopathy: A Pilot Study.

PubMed

Goni, Vijay G; Singh Jhala, Sampat; Gopinathan, Nirmal Raj; Behera, Prateek; Batra, Y K; R H H, Arjun; Guled, Uday; Vardhan, Harsha

2015-08-15

Prospective randomized pilot study. Evaluation of the efficacy of epidural perineural injection of autologous conditioned serum (ACS) versus methylprednisone (MPS) in unilateral cervical radiculopathy patients. Cervical radiculopathy is often treated by nonoperative and operative means. Guided injections of steroids have been used previously. We used ACS, an orthobiologic derived from patients' own blood in patients of unilateral cervical radiculopathy. Forty patients were equally allocated into ACS and MPS groups and were injected with 2.5 to 3 mL of ACS or MPS, respectively, under image guidance into the perineural area of the affected nerve root. They were followed up for 6 months with visual analogue scale for pain, neck pain disability scale in Hindi language, neck disability index, and Short Form of Health Survey-12 (SF-12). Patients who had received injections of ACS and MPS both had improvements in the scores of the evaluation tools. The improvement in the ACS patients was gradual and sustained during the entire study period whereas that in the MPS group had some deterioration over time. No major complications were noted among the 2 groups. Minor complications were noted in both the groups. ACS can be considered an equally good or better modality of nonoperative management in patients of unilateral cervical radiculopathy as MPS. The safety profile is good and the improvement seen is sustained over time. Thus, it may be offered to affected patients before offering them surgery. 2.

Improved Self-Acceptance, Quality of Life, and Stress Level from Participation in a Worksite Yoga Foundations Program: A Pilot Study.

PubMed

Casey, Lori J; Van Rooy, Kimberly M; Sutherland, Stephanie J; Jenkins, Sarah M; Rosedahl, Jordan K; Wood, Nadia G; Ebbert, Jon O; Lopez-Jimenez, Francisco; Egginton, Jason S; Sim, Leslie A; Clark, Matthew M

2018-03-29

Yoga is increasing in popularity in the United States and across the globe. However, most yoga programs are provided outside the worksite; although many companies offer worksite wellness programs, at present there is limited documentation regarding the potential benefits of participating in a worksite yoga program. Therefore, the purpose of this project was to examine the potential effect of a worksite yoga program on self-acceptance, quality of life, and perceived stress. A prospective cohort pilot study that examined a structured worksite yoga program was designed and tailored to individuals new to yoga. The 8-week Yoga Foundations program was conducted at an academic medical center's worksite wellness center with 86 subjects. Outcome measures were the 36-item Self-Acceptance Scale; a six-item quality-of-life measure that assesses overall, social, mental, physical, emotional, and spiritual well-being; and the ten-item Perceived Stress Scale. Participants demonstrated significant improvement in their overall self-acceptance ( p < 0.001), quality of life ( p < 0.001), and perceived stress ( p ≤ 0.001) levels. They also highly rated the yoga instructors and the weekly format of the program. Participation in a Yoga Foundations program was associated with improvements in self-acceptance, quality of life and stress levels in worksite wellness center members. Future studies should use randomized designs and examine other wellness domains to learn more about the potential benefits of worksite yoga programs.

Effects of clopidogrel therapy on whole blood platelet aggregation, the Plateletworks® assay and coagulation parameters in cats with asymptomatic hypertrophic cardiomyopathy: a pilot study.

PubMed

den Toom, M L; van Leeuwen, M W; Szatmári, V; Teske, E

2017-12-01

Although scientific evidence is limited, clopidogrel is frequently used as prophylaxis for arterial thromboembolism in cats with hypertrophic cardiomyopathy (HCM). Evaluating effects of clopidogrel therapy in asymptomatic cats with HCM on (1) conventional whole blood aggregation (WBA), (2) alternative platelet aggregation assessed with tubes of the Plateletworks® assay and (3) standard coagulation parameters. Prospective, randomized, double-blind, placebo-controlled pilot study. Fourteen asymptomatic HCM cats were randomly allocated to receive placebo (n = 5) or clopidogrel (18.75 mg/cat q24h, n = 9) as part of a larger study. Aggregation responses (to 20 µM adenosine diphosphate (ADP) and 10 µg/ml collagen) in WBA and the Plateletworks® assay and standard coagulation parameters were evaluated at baseline and after seven days of therapy. Clopidogrel therapy significantly reduced aggregation responses to ADP and collagen in the Plateletworks® agonists tubes (ADP and collagen: P < 0.001), but did not significantly reduce aggregation responses to ADP and collagen in the WBA technique (ADP: P = 0.07, collagen: P = 0.30). Clopidogrel therapy did not show a significant effect on prothrombin time, activated partial thromboplastin time, antithrombin, D-dimers and fibrinogen concentrations. Clopidogrel therapy at a dose of 18.75 mg/cat q24h for seven days causes a significant decrease in in vitro platelet aggregation evaluated with the Plateletworks® assay, without affecting standard coagulation parameters in cats with asymptomatic HCM.

The effect of Burns & Wounds (B&W)/burdock leaf therapy on burn-injured Amish patients: a pilot study measuring pain levels, infection rates, and healing times.

PubMed

Kolacz, Nicole M; Jaroch, Mark T; Bear, Monica L; Hess, Rosanna F

2014-12-01

The purposes of this pilot study were to measure pain associated with dressing changes, assess the presence of infection, and document healing times of burn-injured Amish in central Ohio using an herbal therapy consisting of Burns and Wounds™ ointment (B&W) and burdock (Arctium ssp.) leaves. B&W contains honey, lanolin, olive oil, wheat germ oil, marshmallow root, Aloe vera gel, wormwood, comfrey root, white oak bark, lobelia inflata, vegetable glycerin, bees wax, and myrrh. A prospective, case series design guided the study within a community-based participatory research framework. Amish burn dressers provided burn care. Registered nurses monitored each case and documented findings. Pain scores were noted and burns were inspected for infection during dressing changes; healing times were measured from day of burn to complete closure of the skin. All cases were photographed. Between October 2011 and May 2013, five Amish were enrolled. All had first- and second-degree burns. B&W/burdock leaf dressing changes caused minimal or no pain; none of the burns became infected, and healing times averaged less than 14 days. The use of this herbal remedy appears to be an acceptable alternative to conventional burn care for these types of burns. The trauma of dressing changes was virtually nonexistent. Nurses working in communities with Amish residents should be aware of this herbal-based method of burn care and monitor its use when feasible. © The Author(s) 2014.

Leading teams during simulated pediatric emergencies: a pilot study

PubMed Central

Coolen, Ester H; Draaisma, Jos M; den Hamer, Sabien; Loeffen, Jan L

2015-01-01

Purpose Leadership has been identified as a key variable for the functioning of teams and as one of the main reasons for success or failure of team-based work systems. Pediatricians often function as team leaders in the resuscitation of a critically ill child. However, pediatric residents often report having little opportunity to perform in the role of team leader during residency. In order to gain more insight into leadership skills and behaviors, we classified leadership styles of pediatric residents during simulated emergencies. Methods We conducted a prospective quantitative study to investigate leadership styles used by pediatric residents during simulated emergencies with clinical deterioration of a child at a pediatric ward. Using videotaped scenarios of 48 simulated critical events among 12 residents, we were able to classify verbal and nonverbal communication into different leadership styles according to the situational leadership theory. Results The coaching style (mean 54.5%, SD 7.8) is the most frequently applied by residents, followed by the directing style (mean 35.6%, SD 4.1). This pattern conforms to the task- and role-related requirements in our scenarios and it also conforms to the concept of situational leadership. We did not find any significant differences in leadership style according to the postgraduate year or scenario content. Conclusion The model used in this pilot study helps us to gain a better understanding of the development of effective leadership behavior and supports the applicability of situational leadership theory in training leadership skills during residency. PMID:25610010

Hydrogen production from algal biomass - Advances, challenges and prospects.

PubMed

Show, Kuan-Yeow; Yan, Yuegen; Ling, Ming; Ye, Guoxiang; Li, Ting; Lee, Duu-Jong

2018-06-01

Extensive effort is being made to explore renewable energy in replacing fossil fuels. Biohydrogen is a promising future fuel because of its clean and high energy content. A challenging issue in establishing hydrogen economy is sustainability. Biohydrogen has the potential for renewable biofuel, and could replace current hydrogen production through fossil fuel thermo-chemical processes. A promising source of biohydrogen is conversion from algal biomass, which is abundant, clean and renewable. Unlike other well-developed biofuels such as bioethanol and biodiesel, production of hydrogen from algal biomass is still in the early stage of development. There are a variety of technologies for algal hydrogen production, and some laboratory- and pilot-scale systems have demonstrated a good potential for full-scale implementation. This work presents an elucidation on development in biohydrogen encompassing biological pathways, bioreactor designs and operation and techno-economic evaluation. Challenges and prospects of biohydrogen production are also outlined. Copyright © 2018 Elsevier Ltd. All rights reserved.

Cysticlean® a highly pac standardized content in the prevention of recurrent urinary tract infections: an observational, prospective cohort study.

PubMed

Sánchez Ballester, Francisco; Ruiz Vidal, Vicente; López Alcina, Emilio; Domenech Perez, Cristina; Escudero Fontano, Eva; Oltra Benavent, Ana; Montoliu García, Ana; Sobrón Bustamante, Marco

2013-06-05

The present study was aimed at determining the prophylactic efficacy of American cranberry (AC) extract (Cysticlean®) in women with recurrent symptomatic postcoital urinary tract infections (PCUTI), non-consumer of AC extract in the past 3 months before inclusion, and to determine changes in their quality of life (QoL). This was a single center, observational, prospective study in a total of 20 women (mean age 35.2 years; 50.0% were married). Patients were followed up for 3 and 6 months during treatment. The number of PCUTIs in the previous 3 months prior to start the treatment with Cysticlean® was 2.8±1.3 and it was reduced to 0.2±0.5 at Month 6 (P<0.0001), which represent a 93% improvement. At baseline, the mean score on the VAS scale (range from 0 to 100) for assessing the QoL was 62.4±19.1, increasing to 78.2±12.4 at Month 6 (P=0.0002), which represents a 20% improvement. All patients had an infection with positive urine culture at baseline, after 6 months there were only 3 symptomatic infections (P<0.001). The most common bacterium was Escherichia coli. Prophylaxis with American cranberry extract (Cysticlean®) could be an alternative to classical therapies with antibiotics. Further studies are needed to confirm results obtained in this pilot study.

Cysticlean® a highly pac standardized content in the prevention of recurrent urinary tract infections: an observational, prospective cohort study

PubMed Central

2013-01-01

Background The present study was aimed at determining the prophylactic efficacy of American cranberry (AC) extract (Cysticlean®) in women with recurrent symptomatic postcoital urinary tract infections (PCUTI), non-consumer of AC extract in the past 3 months before inclusion, and to determine changes in their quality of life (QoL). Methods This was a single center, observational, prospective study in a total of 20 women (mean age 35.2 years; 50.0% were married). Patients were followed up for 3 and 6 months during treatment. Results The number of PCUTIs in the previous 3 months prior to start the treatment with Cysticlean® was 2.8±1.3 and it was reduced to 0.2±0.5 at Month 6 (P<0.0001), which represent a 93% improvement. At baseline, the mean score on the VAS scale (range from 0 to 100) for assessing the QoL was 62.4±19.1, increasing to 78.2±12.4 at Month 6 (P=0.0002), which represents a 20% improvement. All patients had an infection with positive urine culture at baseline, after 6 months there were only 3 symptomatic infections (P<0.001). The most common bacterium was Escherichia coli. Conclusions Prophylaxis with American cranberry extract (Cysticlean®) could be an alternative to classical therapies with antibiotics. Further studies are needed to confirm results obtained in this pilot study. PMID:23738867

A pilot audit of a protocol for ambulatory investigation of predicted low-risk patients with possible pulmonary embolism.

PubMed

McDonald, A H; Murphy, R

2011-09-01

Patients with possible pulmonary embolism (PE) commonly present to acute medical services. Research has led to the identification of low-risk patients suitable for ambulatory management. We report on a protocol designed to select low-risk patients for ambulatory investigation if confirmatory imaging is not available that day. The protocol was piloted in the Emergency Department and Medical Assessment Area at the Royal Infirmary of Edinburgh. We retrospectively analysed electronic patient records in an open observational audit of all patients managed in the ambulatory arm over five months of use. We analysed 45 patients' records. Of these, 91.1% required imaging to confirm or refute PE, 62.2% received a computed tomography pulmonary angiogram (CTPA). In 25% of patients, PE was confirmed with musculoskeletal pain (22.7%), and respiratory tract infection (15.9%) the next most prevalent diagnoses. Alternative diagnoses was provided by CTPA in 32% of cases. We identified no adverse events or readmissions but individualised follow-up was not attempted. The data from this audit suggests this protocol can be applied to select and manage low-risk patients suitable for ambulatory investigation of possible PE. A larger prospective comparative study would be required to accurately define the safety and effectiveness of this protocol.

The Effects of Longitudinal Control-System Dynamics on Pilot Opinion and Response Characteristics as Determined from Flight Tests and from Ground Simulator Studies

NASA Technical Reports Server (NTRS)

Sadoff, Melvin

1958-01-01

The results of a fixed-base simulator study of the effects of variable longitudinal control-system dynamics on pilot opinion are presented and compared with flight-test data. The control-system variables considered in this investigation included stick force per g, time constant, and dead-band, or stabilizer breakout force. In general, the fairly good correlation between flight and simulator results for two pilots demonstrates the validity of fixed-base simulator studies which are designed to complement and supplement flight studies and serve as a guide in control-system preliminary design. However, in the investigation of certain problem areas (e.g., sensitive control-system configurations associated with pilot- induced oscillations in flight), fixed-base simulator results did not predict the occurrence of an instability, although the pilots noted the system was extremely sensitive and unsatisfactory. If it is desired to predict pilot-induced-oscillation tendencies, tests in moving-base simulators may be required. It was found possible to represent the human pilot by a linear pilot analog for the tracking task assumed in the present study. The criterion used to adjust the pilot analog was the root-mean-square tracking error of one of the human pilots on the fixed-base simulator. Matching the tracking error of the pilot analog to that of the human pilot gave an approximation to the variation of human-pilot behavior over a range of control-system dynamics. Results of the pilot-analog study indicated that both for optimized control-system dynamics (for poor airplane dynamics) and for a region of good airplane dynamics, the pilot response characteristics are approximately the same.

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...

Pilot study assessing the feasibility of applying bilateral subthalamic nucleus deep brain stimulation in very early stage Parkinson's disease: study design and rationale.

PubMed

Charles, David; Tolleson, Christopher; Davis, Thomas L; Gill, Chandler E; Molinari, Anna L; Bliton, Mark J; Tramontana, Michael G; Salomon, Ronald M; Kao, Chris; Wang, Lily; Hedera, Peter; Phibbs, Fenna T; Neimat, Joseph S; Konrad, Peter E

2012-01-01

Deep brain stimulation provides significant symptomatic benefit for people with advanced Parkinson's disease whose symptoms are no longer adequately controlled with medication. Preliminary evidence suggests that subthalamic nucleus stimulation may also be efficacious in early Parkinson's disease, and results of animal studies suggest that it may spare dopaminergic neurons in the substantia nigra. We report the methodology and design of a novel Phase I clinical trial testing the safety and tolerability of deep brain stimulation in early Parkinson's disease and discuss previous failed attempts at neuroprotection. We recently conducted a prospective, randomized, parallel-group, single-blind pilot clinical trial of deep brain stimulation in early Parkinson's disease. Subjects were randomized to receive either optimal drug therapy or deep brain stimulation plus optimal drug therapy. Follow-up visits occurred every six months for a period of two years and included week-long therapy washouts. Thirty subjects with Hoehn & Yahr Stage II idiopathic Parkinson's disease were enrolled over a period of 32 months. Twenty-nine subjects completed all follow-up visits; one patient in the optimal drug therapy group withdrew from the study after baseline. Baseline characteristics for all thirty patients were not significantly different. This study demonstrates that it is possible to recruit and retain subjects in a clinical trial testing deep brain stimulation in early Parkinson's disease. The results of this trial will be used to support the design of a Phase III, multicenter trial investigating the efficacy of deep brain stimulation in early Parkinson's disease.

Pilot Study Assessing the Feasibility of Applying Bilateral Subthalamic Nucleus Deep Brain Stimulation in Very Early Stage Parkinson's Disease: Study design and rationale

PubMed Central

Charles, David; Tolleson, Christopher; Davis, Thomas L.; Gill, Chandler E.; Molinari, Anna L.; Bliton, Mark J.; Tramontana, Michael G.; Salomon, Ronald M.; Kao, Chris; Wang, Lily; Hedera, Peter; Phibbs, Fenna T.; Neimat, Joseph S.; Konrad, Peter E.

2014-01-01

Background Deep brain stimulation provides significant symptomatic benefit for people with advanced Parkinson's disease whose symptoms are no longer adequately controlled with medication. Preliminary evidence suggests that subthalamic nucleus stimulation may also be efficacious in early Parkinson's disease, and results of animal studies suggest that it may spare dopaminergic neurons in the substantia nigra. Objective We report the methodology and design of a novel Phase I clinical trial testing the safety and tolerability of deep brain stimulation in early Parkinson's disease and discuss previous failed attempts at neuroprotection. Methods We recently conducted a prospective, randomized, parallel-group, single-blind pilot clinical trial of deep brain stimulation in early Parkinson's disease. Subjects were randomized to receive either optimal drug therapy or deep brain stimulation plus optimal drug therapy. Follow-up visits occurred every six months for a period of two years and included week-long therapy washouts. Results Thirty subjects with Hoehn & Yahr Stage II idiopathic Parkinson's disease were enrolled over a period of 32 months. Twenty-nine subjects completed all follow-up visits; one patient in the optimal drug therapy group withdrew from the study after baseline. Baseline characteristics for all thirty patients were not significantly different. Conclusions This study demonstrates that it is possible to recruit and retain subjects in a clinical trial testing deep brain stimulation in early Parkinson's disease. The results of this trial will be used to support the design of a Phase III, multicenter trial investigating the efficacy of deep brain stimulation in early Parkinson's disease. PMID:23938229

"Black cloud" vs. "white cloud" physicians - Myth or reality in apheresis medicine?

PubMed

Pham, Huy P; Raju, Dheeraj; Jiang, Ning; Williams, Lance A

2017-08-01

Many practitioners believe in the phenomenon of either being labeled a "black cloud" or "white cloud" while on-call. A "white-cloud" physician is one who usually gets fewer cases. A "black-cloud" is one who often has more cases. It is unclear if the designation is only superstitious or if there is some merit. Our aim is to objectively assess this phenomenon in apheresis medicine at our center. A one-year prospective study from 12/2014 to 11/2015 was designed to evaluate the number of times apheresis physicians and nurses were involved with emergent apheresis procedures between the hours from 10 PM and 7 AM. Other parameters collected include the names of the physician, apheresis nurse, type of emergent apheresis procedure, day of the week, and season of the year. During the study period, 32 emergent procedures (or "black-cloud" events) occurred. The median time between two consecutive events was 8 days (range: 1-34 days). We found no statistically significant association between the "black-cloud" events and attending physicians, nurses, day of the week, or season of the year by Chi-square and Fisher's analyses. However, exploratory analysis using association rule demonstrated that "black-cloud" events were more likely to happen on Thursday (2.19 times), with attending physician 2 (1.18 times), and during winter (1.15 times). The results of this pilot study may support the common perception that some physicians or nurses are either "black cloud" or "white cloud". A larger, multi-center study population is needed to validate the results of this pilot study. © 2016 Wiley Periodicals, Inc.

Neuropsychological alterations and neuroradiological findings in patients with post-traumatic concussion: Results of a pilot study.

PubMed

Rădoi, A; Poca, M A; Cañas, V; Cevallos, J M; Membrado, L; Saavedra, M C; Vidal, M; Martínez-Ricarte, F; Sahuquillo, J

2016-12-19

Mild traumatic brain injury (mTBI) has traditionally been considered to cause no significant brain damage since symptoms spontaneously remit after a few days. However, this idea is facing increasing scrutiny. The purpose of this study is to demonstrate the presence of early cognitive alterations in a series of patients with mTBI and to link these findings to different markers of brain damage. We conducted a prospective study of a consecutive series of patients with mTBI who were evaluated over a 12-month period. Forty-one (3.7%) of the 1144 included patients had experienced a concussion. Patients underwent a routine clinical evaluation and a brain computed tomography (CT) scan, and were also administered a standardised test for post-concussion symptoms within the first 24hours of mTBI and also 1 to 2 weeks later. The second assessment also included a neuropsychological test battery. The results of these studies were compared to those of a control group of 28 healthy volunteers with similar characteristics. Twenty patients underwent an MRI scan. Verbal memory and learning were the cognitive functions most affected by mTBI. Seven out of the 20 patients with normal CT findings displayed structural alterations on MR images, which were compatible with diffuse axonal injury in 2 cases. Results from this pilot study suggest that early cognitive alterations and structural brain lesions affect a considerable percentage of patients with post-concussion syndrome following mTBI. Copyright © 2016 Sociedad Española de Neurología. Publicado por Elsevier España, S.L.U. All rights reserved.

Inflammation, functional status, and weight loss during recovery from cardiac surgery in older adults: a pilot study.

PubMed

DiMaria-Ghalili, Rose Ann; Sullivan-Marx, Eileen M; Compher, Charlene

2014-07-01

To determine the nutritional, inflammatory, and functional aspects of unintentional weight loss after cardiac surgery that warrant further investigation. Twenty community-dwelling adults > 65 years old undergoing cardiac surgery (coronary artery bypass graft [CABG] or CABG + valve) were recruited for this prospective longitudinal (preoperative and 4-6 weeks postdischarge) pilot study. Anthropometrics (weight, standing height, and mid-arm and calf circumference), nutritional status (Mini-Nutritional Assessment™ [MNA]), appetite, physical performance (timed chair stand), muscle strength (hand grip) and functional status (basic and instrumental activities of daily living), and inflammatory markers (plasma leptin, ghrelin, interleukin [IL]-6, high-sensitivity[hs] C-reactive protein, and serum albumin and prealbumin) were measured. Participants who completed the study (n = 11 males, n = 3 females) had a mean age 70.21 ± 4.02 years. Of these, 12 lost 3.66 ± 1.44 kg over the study period. Weight, BMI, activities of daily living, and leptin decreased over time (p < .05). IL-6 increased over time (p < .05). Ghrelin, hs-CRP, and timed chair stand increased over time in those who underwent combined procedures (p < .05). Grip strength decreased in those who developed complications (p = .004). Complications, readmission status, and lowered grip strength were found in those with low preoperative MNA scores (p < .05). After cardiac surgery, postdischarge weight loss occurs during a continued inflammatory response accompanied by decreased physical functioning and may not be a positive outcome. The impacts of weight loss, functional impairment, and inflammation during recovery on disability and frailty warrant further study. © The Author(s) 2013.

[The efficacy of the exoskeleton ExoAtlet to restore walking in patients with multiple sclerosis].

PubMed

Kotov, S V; Lijdvoy, V Yu; Sekirin, A B; Petrushanskaya, K A; Pismennaya, E V

2017-01-01

To investigate the efficacy and safety of the exoskeleton ExoAtlet in complex therapy of patients with multiple sclerosis (MS). A pilot study within the prospective open controlled program was conducted. Eighteen patients with relapsing-remitting MS (RRMS) in remission and secondary progressive MS (SPMS) with the level of neurological deficit on the EDSS from 3 to 7 points have completed the study. EDSS, MSFC, HADS, MoCA scales were administered and the force measuring insoles F-Scan Tekscan (USA) were used to study the biomechanics of walking. Good tolerability of workload within 30-40 min. was observed. The improvement in the EDSS was detected in 9 patients, in whole, a significant positive trend (p<0.01) was shown. The study of the biomechanics of the walk showed its significant impairment compared to healthy individuals: reduction of parameters of rate, speed and step length, significant instability, pronounced asymmetry, the decrease in support and shock lower limb function, high coefficient of variability of the parameters, the phenomenon of recurrence of the vertical component of support reactions. After a course of exercise of walking in the exoskeleton, the walking speed and stability increased, oscillation of the body decreased, support function increased, the phenomenon of cyclical changes of the vertical component of support reactions reduced. The results of the pilot study showed promising future research opportunities for robotic-assisted walking and maintenance of the vertical posture with the help of the exoskeleton ExoAtlet to restore the abilities of movement in MS patients with locomotor disorders.

[Effects of an intensive thalassotherapy and aquatic therapy program in stroke patients. A pilot study].

PubMed

Morer, C; Boestad, C; Zuluaga, P; Alvarez-Badillo, A; Maraver, F

2017-09-16

Stroke remains the leading cause of acquired disability. Health and social planning and management may vary and although prevention is crucial, having better treatments and strategies to reduce disability is needed. To determine the effect of an intensive program of thalassotherapy and aquatic therapy in stroke patients, valuing clinical parameters and functional validated scales. A quasi-experimental prospective study consisting of a specific program assessed pre- and post- 3 weeks treatment to 26 stroke patients with a mild-moderate disability. The outcomes measured were: Berg Balance scale, Timed Up and Go test, 10-meter walking test, 6-minute walking test and pain Visual Analogue Scale. After intervention, participants had a significant improvement in all outcomes measured. Our results suggest that an intensive program of thalassotherapy and aquatic therapy could be useful during stroke rehabilitation to improve balance, gait and pain.

Altered slow wave activity in major depressive disorder with hypersomnia: a high density EEG pilot study

PubMed Central

Plante, David T.; Landsness, Eric C.; Peterson, Michael J.; Goldstein, Michael R.; Wanger, Tim; Guokas, Jeff J.; Tononi, Giulio; Benca, Ruth M.

2012-01-01

Hypersomnolence in major depressive disorder (MDD) plays an important role in the natural history of the disorder, but the basis of hypersomnia in MDD is poorly understood. Slow wave activity (SWA) has been associated with sleep homeostasis, as well as sleep restoration and maintenance, and may be altered in MDD. Therefore, we conducted a post-hoc study that utilized high density electroencephalography (hdEEG) to test the hypothesis that MDD subjects with hypersomnia (HYS+) would have decreased SWA relative to age and sex-matched MDD subjects without hypersomnia (HYS−) and healthy controls (n=7 for each group). After correcting for multiple comparisons using statistical non-parametric mapping, HYS+ subjects demonstrated significantly reduced parieto-occipital all-night SWA relative to HYS− subjects. Our results suggest hypersomnolence may be associated with topographic reductions in SWA in MDD. Further research using adequately powered prospective design is indicated to confirm these findings. PMID:22512951

Feasibility of Combining Common Data Elements Across Studies to Test a Hypothesis.

PubMed

Corwin, Elizabeth J; Moore, Shirley M; Plotsky, Andrea; Heitkemper, Margaret M; Dorsey, Susan G; Waldrop-Valverde, Drenna; Bailey, Donald E; Docherty, Sharron L; Whitney, Joanne D; Musil, Carol M; Dougherty, Cynthia M; McCloskey, Donna J; Austin, Joan K; Grady, Patricia A

2017-05-01

The purpose of this article is to describe the outcomes of a collaborative initiative to share data across five schools of nursing in order to evaluate the feasibility of collecting common data elements (CDEs) and developing a common data repository to test hypotheses of interest to nursing scientists. This initiative extended work already completed by the National Institute of Nursing Research CDE Working Group that successfully identified CDEs related to symptoms and self-management, with the goal of supporting more complex, reproducible, and patient-focused research. Two exemplars describing the group's efforts are presented. The first highlights a pilot study wherein data sets from various studies by the represented schools were collected retrospectively, and merging of the CDEs was attempted. The second exemplar describes the methods and results of an initiative at one school that utilized a prospective design for the collection and merging of CDEs. Methods for identifying a common symptom to be studied across schools and for collecting the data dictionaries for the related data elements are presented for the first exemplar. The processes for defining and comparing the concepts and acceptable values, and for evaluating the potential to combine and compare the data elements are also described. Presented next are the steps undertaken in the second exemplar to prospectively identify CDEs and establish the data dictionaries. Methods for common measurement and analysis strategies are included. Findings from the first exemplar indicated that without plans in place a priori to ensure the ability to combine and compare data from disparate sources, doing so retrospectively may not be possible, and as a result hypothesis testing across studies may be prohibited. Findings from the second exemplar, however, indicated that a plan developed prospectively to combine and compare data sets is feasible and conducive to merged hypothesis testing. Although challenges exist in combining CDEs across studies into a common data repository, a prospective, well-designed protocol for identifying, coding, and comparing CDEs is feasible and supports the development of a common data repository and the testing of important hypotheses to advance nursing science. Incorporating CDEs across studies will increase sample size and improve data validity, reliability, transparency, and reproducibility, all of which will increase the scientific rigor of the study and the likelihood of impacting clinical practice and patient care. © 2017 Sigma Theta Tau International.

A Study of the Characteristics of Human-Pilot Control Response to Simulated Aircraft Lateral Motions

NASA Technical Reports Server (NTRS)

Cheatham, Donald C

1954-01-01

Report presents the results of studies made in an attempt to provide information on the control operations of the human pilot. These studies included an investigation of the ability of pilots to control simulated unstable yawing oscillations, a study of the basic characteristics of human-pilot control response, and a study to determine whether and to what extent pilot control response can be represented in an analytical form.

Tryptophan-kynurenine and lipid related metabolites as blood biomarkers for first-episode drug-naïve patients with major depressive disorder: An exploratory pilot case-control study.

PubMed

Kuwano, Nobuki; Kato, Takahiro A; Setoyama, Daiki; Sato-Kasai, Mina; Shimokawa, Norihiro; Hayakawa, Kohei; Ohgidani, Masahiro; Sagata, Noriaki; Kubo, Hiroaki; Kishimoto, Junji; Kang, Dongchon; Kanba, Shigenob

2018-04-15

Early intervention in depression has been critical to prevent its negative impact including suicide. Recent blood biomarker studies for major depressive disorder (MDD) have suggested that tryptophan-kynurenine and lipid related metabolites are involved in the pathophysiology of MDD. However, there have been limited studies investigating these blood biomarkers in first-episode drug-naïve MDD, which are particularly important for early intervention in depression. As an exploratory pilot case-control study, we examined the above blood biomarkers, and analyzed how these biomarkers are associated with clinical variables in first-episode drug-naïve MDD patients, based on metabolome/lipidome analysis. Plasma tryptophan and kynurenine levels were significantly lower in MDD group (N = 15) compared to healthy controls (HC) group (N = 19), and plasma tryptophan was the significant biomarker to identify MDD group (area under the curve = 0.740). Lower serum high density lipoprotein-cholesterol (HDL-C) was the predictive biomarker for severity of depression in MDD group (R 2 = 0.444). Interestingly, depressive symptoms were variously correlated with plasma tryptophan-kynurenine and lipid related metabolites. Moreover, plasma tryptophan-kynurenine metabolites and cholesteryl esters (CEs) were significantly correlated in MDD group, but not in HC group. This study had small sample size, and we did not use the multiple test correction. This is the first study to suggest that not only tryptophan-kynurenine metabolites but also HDL-C and CEs are important blood biomarkers for first-episode drug-naïve MDD patients. The present study sheds new light on early intervention in clinical practice in depression, and further clinical studies especially large-scale prospective studies are warranted. Copyright © 2018 Elsevier B.V. All rights reserved.

Quality of life in very elderly radiotherapy patients: a prospective pilot study using the EORTC QLQ-ELD14 module.

PubMed

Kaufmann, Anne; Schmidt, Heike; Ostheimer, Christian; Ullrich, Janine; Landenberger, Margarete; Vordermark, Dirk

2015-07-01

In very elderly cancer patients, health-related quality of life (HRQOL) is a particularly important issue but has rarely been studied due to a lack of specific instruments and of reference data. We performed a prospective analysis of HRQOL in patients ≥80 years undergoing radiotherapy with the newly validated elderly-specific HRQOL module EORTC QLQ-ELD14. We prospectively assessed HRQOL in n = 50 radiotherapy patients ≥80 years (32% lung, 20% gastrointestinal, 8% each of breast, head and neck, gynecologic cancer) at the start (t1), end (t2), and 6 months after (t3) radiotherapy, using EORTC QLQ-C30 and EORTC QLQ-ELD14. Overall survival was determined in the whole cohort and subgroups. Median overall survival from the start of radiotherapy was 15 months; 1-year and 2-year overall survival rates were 57.1 and 31.0%, respectively. Eastern Cooperative Oncology Group (ECOG) performance status <2, Charlson comorbidity index ≤6, curative treatment intention, local tumor stage Union Internationale Contre le Cancer (UICC I, II), and total dose >45 Gy were associated with prolonged survival. No significant changes in any HRQOL domain were observed during the course of treatment (t1 to t2). Six months after radiotherapy (t3), a significant and clinically relevant deterioration of HRQOL was seen in EORTC QLQ-C30 for physical function and role function and in EORTC QLQ-ELD14 for future worries, burden of illness, and family support. In radiotherapy patients ≥80 years, HRQOL was maintained until the end of radiotherapy but deteriorated in general and elderly-specific areas thereafter, suggesting a need to develop specific supportive interventions for this age group.

Quit and Smoking Reduction Rates in Vape Shop Consumers: A Prospective 12-Month Survey

PubMed Central

Polosa, Riccardo; Caponnetto, Pasquale; Cibella, Fabio; Le-Houezec, Jacques

2015-01-01

Aims: Here, we present results from a prospective pilot study that was aimed at surveying changes in daily cigarette consumption in smokers making their first purchase at vape shops. Modifications in products purchase were also noted. Design: Participants were instructed how to charge, fill, activate and use their e-cigarettes (e-cigs). Participants were encouraged to use these products in the anticipation of reducing the number of cig/day smoked. Settings: Staff from LIAF contacted 10 vape shops in the province of the city of Catania (Italy) that acted as sponsors to the 2013 No Tobacco Day. Participants: 71 adult smokers (≥18 years old) making their first purchase at local participating vape shops were asked by professional retail staff to complete a form. Measurements: Their cigarette consumption was followed-up prospectively at 6 and 12 months. Details of products purchase (i.e., e-cigs hardware, e-liquid nicotine strengths and flavours) were also noted. Findings: Retention rate was elevated, with 69% of participants attending their final follow-up visit. At 12 month, 40.8% subjects could be classified as quitters, 25.4% as reducers and 33.8% as failures. Switching from standard refillables (initial choice) to more advanced devices (MODs) was observed in this study (from 8.5% at baseline to 18.4% at 12 month) as well as a trend in decreasing the e-liquid nicotine strength, with more participants adopting low nicotine strength (from 49.3% at baseline to 57.1% at 12 month). Conclusions: We have found that smokers purchasing e-cigarettes from vape shops with professional advice and support can achieve high success rates. PMID:25811767

Pilot study of radiofrequency interstitial tumor ablation (RITA) for the treatment of radio-recurrent prostate cancer.

PubMed

Shariat, Shahrokh F; Raptidis, Grigorios; Masatoschi, Muramoto; Bergamaschi, Franco; Slawin, Kevin M

2005-11-01

To prospectively evaluate the feasibility, safety, morbidity, and preliminary efficacy of radiofrequency interstitial tumor ablation (RITA) for the focal treatment of patients with local prostate cancer recurrence. Eleven patients with biopsy-proven, hormone-naïve, clinically localized prostate cancer were enrolled in a prospective phase I/II trial. Eight patients had failed prior radiation therapy and three were not candidates for curative primary therapy (median Gleason score 7 and 6, respectively). Median follow-up was 20 months. All patients were treated with RITA in an office setting, under intravenous sedation and were discharged after the procedure. Radiofrequency energy was applied via needles placed transperineally under transrectal ultrasound guidance. The placement of 1/4 lesions was aborted in two patients due to increasing rectal temperature. Complications included transient macrohematuria (19%), bladder spasms (9%), and dysuria (9%). Serum PSA levels decreased after RITA >50% in 90% of patients, > 70% in 72% of patients, and > 80% in 46% of patients. The mean PSA doubling time after RITA was slower than that before RITA (37 +/- 22 months vs. 14 +/- 13 months, P = 0.008). At 12 months after RITA, 50% of patients with sufficient follow-up had no residual cancer on repeat systematic 12-core biopsy cores and 67% were cancer-free in biopsy cores sampled from the RITA-treated areas. RITA treatment is a minimal invasive, rapid, user-friendly, office-based procedure that is well tolerated. Focal ablation with RITA results in effective local disease control in patients with non-metastatic prostate cancer recurrence. Larger, prospective, multicenter clinical studies are needed to confirm these findings. Copyright 2005 Wiley-Liss, Inc

Pilot Certification, Age of Pilot, and Drug Use in Fatal Civil Aviation Accidents.

PubMed

Akparibo, Issaka Y; Stolfi, Adrienne

2017-10-01

This study examined the association between mean age of pilot, pilot license, pilot medical certificate and drug use trends in pilots fatally injured in aircraft accidents. The prevalence of prescription drugs, OTC drugs, controlled drugs and drugs that may be potentially impairing was also examined. This study was a descriptive observational study in which the NTSB Aviation Accident Database was searched from the period beginning January 1, 2012 to December 31, 2014. During the study period a total of 706 accidents involving 711 fatalities were investigated by the NTSB. This study included 633 of these accidents, involving 646 fatalities. Of these pilots, 42.1% had drugs in their biological samples. The prevalence of prescription drugs, controlled drugs, OTC drugs, opioids, and potentially impairing drugs in the fatally injured pilot population over the study period was 28.9%, 15.0%, 20.1%, 5.1%, and 25.5%, respectively. Pilots with any drugs in their samples were significantly older than those without drugs. Medical certificate held was associated with drug use; pilots who held third class certificates had the highest prevalence at 54.1%. Pilot license was not associated with drug use. In 3.8% of the accidents, drugs were a contributing factor in the cause. Despite current FAA medical regulations, potentially impairing drugs are frequently found in biological samples of fatally injured pilots in the U.S. More education of airmen by aviation medical examiners is needed on the safety of drug use.Akparibo IY, Stolfi A. Pilot certification, age of pilot, and drug use in fatal civil aviation accidents. Aerosp Med Hum Perform. 2017; 88(10):931-936.

Sodium bicarbonate on severe metabolic acidosis during prolonged cardiopulmonary resuscitation: a double-blind, randomized, placebo-controlled pilot study.

PubMed

Ahn, Shin; Kim, Youn-Jung; Sohn, Chang Hwan; Seo, Dong Woo; Lim, Kyoung Soo; Donnino, Michael W; Kim, Won Young

2018-04-01

Sodium bicarbonate administration during cardiopulmonary resuscitation (CPR) is controversial. Current guidelines recommend sodium bicarbonate injection in patients with existing metabolic acidosis, but clinical trials, particularly, those involving patients with acidosis, are limited. We aimed to evaluate the efficacy of sodium bicarbonate administration in out-of-hospital cardiac arrest (OHCA) patients with severe metabolic acidosis during prolonged CPR. Prospective, double-blind, randomized placebo-controlled pilot trial was conducted between January 2015 and December 2015, at a single center emergency department (ED). After 10 minutes of CPR, patients who failed to achieve return of spontaneous circulation (ROSC) and with severe metabolic acidosis (pH<7.1 or bicarbonate <10 mEq/L) were enrolled. Sodium bicarbonate (n=25) or normal saline (n=25) were administered. The primary end point was sustained ROSC. The secondary end points were the change of acidosis and good neurologic survival. Sodium bicarbonate group had significant effect on pH (6.99 vs. 6.90, P=0.038) and bicarbonate levels (21.0 vs. 8.0 mEq/L, P=0.007). However, no significant differences showed between sodium bicarbonate and placebo groups in sustained ROSC (4.0% vs. 16.0%, P=0.349) or good neurologic survival at 1 month (0.0% vs. 4.0%, P=1.000). The use of sodium bicarbonate improved acid-base status, but did not improve the rate of ROSC and good neurologic survival. We could not draw a conclusion, but our pilot data could be used to design a larger trial to verify the efficacy of sodium bicarbonate. NCT02303548 (http://www.ClinicalTrials.gov).

Two-year pilot study of newborn screening for congenital adrenal hyperplasia in New South Wales compared with nationwide case surveillance in Australia.

PubMed

Gleeson, Helena K; Wiley, Veronica; Wilcken, Bridget; Elliott, Elizabeth; Cowell, Christopher; Thonsett, Michael; Byrne, Geoffrey; Ambler, Geoffrey

2008-10-01

To assess the benefits and practicalities of setting up a newborn screening (NBS) program in Australia for congenital adrenal hyperplasia (CAH) through a 2 year pilot screening in ACT/NSW and comparing with case surveillance in other states. The pilot newborn screening occurred between 1/10/95 and 30/9/97 in NSW/ACT. Concurrently, case reporting for all new CAH cases occurred through the Australian Paediatric Surveillance Unit (APSU) across Australia. Details of clinical presentation, re-sampling and laboratory performance were assessed. 185,854 newborn infants were screened for CAH in NSW/ACT. Concurrently, 30 cases of CAH were reported to APSU, twelve of which were from NSW/ACT. CAH incidence was 1 in 15 488 (screened population) vs 1 in 18,034 births (unscreened) (difference not significant). Median age of initial notification was day 8 with confirmed diagnosis at 13(5-23) days in the screened population vs 16(7-37) days in the unscreened population (not significant). Of the 5 clinically unsuspected males in the screened population, one had mild salt-wasting by the time of notification, compared with salt-wasting crisis in all 6 males from the unscreened population. 96% of results were reported by day 10. Resampling was requested in 637 (0.4%) and median re-sampling delay was 11(0-28) days with higher resample rates in males (p < 0.0001). The within-laboratory cost per case of clinically unsuspected cases was A$42 717. There seems good justification for NBS for CAH based on clear prevention of salt-wasting crises and their potential long-term consequences. Also, prospects exist for enhancing screening performance.

Surgical treatment of hepatocellular carcinoma: evidence-based outcomes.

PubMed

Yamazaki, Shintaro; Takayama, Tadatoshi

2008-02-07

Surgeons may be severely criticized from the perspective of evidence-based medicine because the majority of surgical publications appear not to be convincing. In the top nine surgical journals in 1996, half of the 175 publications refer to pilot studies lacking a control group, 18% to animal experiments, and only 5% to randomized controlled trials (RCT). There are five levels of clinical evidence: level 1 (randomized controlled trial), level 2 (prospective concurrent cohort study), level 3 (retrospective historical cohort study), level 4 (pre-post study), and level 5 (case report). Recently, a Japanese evidence-based guideline for the surgical treatment of hepatocellular carcinoma (HCC) was made by a committee (Chairman, Professor Makuuchi and five members). We searched the literature using the Medline Dialog System with four keywords: HCC, surgery, English papers, in the last 20 years. A total of 915 publications were identified systematically reviewed. At the first selection (in which surgery-dominant papers were selected), 478 papers survived. In the second selection (clearly concluded papers), 181 papers survived. In the final selection (clinically significant papers), 100 papers survived. The evidence level of the 100 surviving papers is shown here: level-1 papers (13%), level-2 papers (11%), level-3 papers (52%), and level-4 papers (24%); therefore, there were 24% prospective papers and 76% retrospective papers. Here, we present a part of the guideline on the five main surgical issues: indication to operation, operative procedure, peri-operative care, prognostic factor, and post-operative adjuvant therapy.

Surgical treatment of hepatocellular carcinoma: Evidence-based outcomes

PubMed Central

Yamazaki, Shintaro; Takayama, Tadatoshi

2008-01-01

Surgeons may be severely criticized from the perspective of evidence-based medicine because the majority of surgical publications appear not to be convincing. In the top nine surgical journals in 1996, half of the 175 publications refer to pilot studies lacking a control group, 18% to animal experiments, and only 5% to randomized controlled trials (RCT). There are five levels of clinical evidence: level 1 (randomized controlled trial), level 2 (prospective concurrent cohort study), level 3 (retrospective historical cohort study), level 4 (pre-post study), and level 5 (case report). Recently, a Japanese evidence-based guideline for the surgical treatment of hepatocellular carcinoma (HCC) was made by a committee (Chairman, Professor Makuuchi and five members). We searched the literature using the Medline Dialog System with four keywords: HCC, surgery, English papers, in the last 20 years. A total of 915 publications were identified systematically reviewed. At the first selection (in which surgery-dominant papers were selected), 478 papers survived. In the second selection (clearly concluded papers), 181 papers survived. In the final selection (clinically significant papers), 100 papers survived. The evidence level of the 100 surviving papers is shown here: level-1 papers (13%), level-2 papers (11%), level-3 papers (52%), and level-4 papers (24%); therefore, there were 24% prospective papers and 76% retrospective papers. Here, we present a part of the guideline on the five main surgical issues: indication to operation, operative procedure, peri-operative care, prognostic factor, and post-operative adjuvant therapy. PMID:18205256

Can Subclinical Rickets Cause SCFE? A Prospective, Pilot Study.

PubMed

Arkader, Alexandre; Woon, Regina P; Gilsanz, Vicente

2015-01-01

Slipped capital femoral epiphysis (SCFE) is a common disorder of the growing hip; however, its etiology remains unknown. Vitamin D (25-OH) is a major regulator of bone homeostasis and calcium metabolism. Vitamin D deficiency is one of the major causes of rickets, and rickets has been associated with SCFE. Increased body mass index (BMI) has been linked to SCFE and obese children are known to have lower vitamin D levels. Therefore, we hypothesize that children who develop SCFE may have subclinical rickets predisposing them to the development of physeal disease. This was a pilot, prospective study designed to determine the relationship between vitamin D, bone, muscle, and fat in patients with SCFE. We enrolled 20 consecutive patients with idiopathic SCFE aged 9 to 14 years. Upon diagnosis, vitamin D, PTH, T4, and thyroid-stimulating hormone blood levels were obtained. A single-slice computed tomography was used to measure cortical bone density (CBD) of the femur. Demographics, BMI, and the results obtained were compared to generate a relationship between vitamin D levels and SCFE. Twenty patients were enrolled, 13 males and 7 females, at an average age of 12 years (range, 9 to 14 y), and mean BMI% was 93.9 (range, 81.3 to 99.5). There were 15 stable and 5 unstable SCFE. Overall, mean and SD values for vitamin D, 25-OH were within the normal range (43.9 ± 13.5). We found no difference in values in vitamin D between nonobese (BMI < 95%) and obese (BMI ≥ 95%) subjects (34.8 ± 16.8 vs. 51.6 ± 22.4, P = 0.144). Moreover, we found no difference in CBD between these 2 groups (1126 ± 33.1 vs. 1147 ± 41.2, P = 0.333). There was no relation between blood values of vitamin D and measures of CBD. Although obese children are known to have lower levels of vitamin D and a higher prevalence of SCFE, we found no correlation between low vitamin D and the development of SCFE in this subset of patients.

Febuxostat for management of tumor lysis syndrome including its effects on levels of purine metabolites in patients with hematological malignancies - a single institution's, pharmacokinetic and pilot prospective study.

PubMed

Takai, Mihoko; Yamauchi, Takahiro; Ookura, Miyuki; Matsuda, Yasufumi; Tai, Katsunori; Kishi, Shinji; Yoshida, Akira; Iwasaki, Hiromichi; Nakamura, Toru; Ueda, Takanori

2014-12-01

Tumor lysis syndrome (TLS) is a life-threatening oncological emergency, and control of serum uric acid level (S-UA) is most important. In this single-institution, short-term and pilot prospective study, the efficacy of a new xanthine oxidase inhibitor, febuxostat, as an alternative to conventional allopurinol, including its effects on hypoxanthine and xanthine, was evaluated in 10 consecutive patients with hematological malignancies at intermediate risk for TLS. Febuxostat at 40 mg (n=7) or 60 mg (n=3) daily was administered according to renal function, and induction chemotherapy was started within 24 h. The primary end-point was the reduction of S-UA to ≤ 7.5 mg/dl by day 5. The median S-UA at base-line was 8.0 mg/dl (range=3.2-10.6 mg/dl). The median S-UA on day 5 after chemotherapy was 3.3 mg/dl (range=1.1-5.8 mg/dl) (p<0.0001, by paired t-test), indicating successful control of S-UA during chemotherapy. All patients achieved S-UA ≤ 7.5 mg/dl. A simultaneous decrease in serum creatinine and increase in estimated glomerular filtration rate were seen. Serum hypoxanthine and xanthine levels (as the consequence of inhibition of xanthine oxidase) were elevated along with the decrease in S-UA. Xanthine level was elevated higher compared to hypoxanthine level and reached the level reported to cause xanthine nephropathy, but no advance of renal impairment was observed. Serum febuxostat concentrations at 2 h after administration were 891.8 ± 285.0 ng/ml (mean ± SE) for the 40-mg dose and 770.6 ± 242.7 ng/ml for the 60-mg dose (p=0.80, unpaired t-test), showing no accumulation in patients with renal impairment. No febuxostat-related adverse reactions were noted. No patients experienced progressive TLS. Febuxostat is promising for the management of TLS of an intermediate-risk patient and further observation and reevaluation regarding xanthine nephropathy should be performed. Copyright© 2014 International Institute of Anticancer Research (Dr. John G. Delinassios), All rights reserved.

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

PubMed

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

2013-02-01

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

Angina on the Palm: randomized controlled pilot trial of Palm PDA software for referrals for cardiac testing.

PubMed

Greiver, Michelle; Drummond, Neil; White, David; Weshler, Jason; Moineddin, Rahim

2005-03-01

Personal digital assistants (PDAs) are popular with physicians: in 2003, 33% of Canadian doctors reported using them in their practices. We do not know, however, whether using a PDA changes the behaviour of practising physicians. We studied the effectiveness of a PDA software application to help family physicians diagnose angina among patients with chest pain. Prospective randomized controlled pilot trial using a cluster design. Primary care practices in the Toronto area. Eighteen family physicians belonging to the North Toronto Primary Care Research Network (Nortren) or recruited from a local hospital. We randomized physicians to receive a Palm PDA (which included the angina diagnosis software) or to continue conventional care. Physicians prospectively recorded the process of care for patients aged 30 to 75 presenting with suspected angina, over 7 months. Did the process of care for patients with suspected angina improve when their physicians had PDAs and software? The primary outcomes we looked at were frequency of cardiac stress test orders for suspected angina, and the appropriateness of referral for cardiac stress testing at presentation and for nuclear cardiology testing after cardiac stress testing. Secondary outcome was referrals to cardiologists. The software led to more overall use of cardiac stress testing (81% vs 50%). The absolute increase was 31% (P = .007, 95% confidence interval [CI] 8% to 58%). There was a trend toward more appropriate use of stress testing (48.6% with the PDA vs 28.6% control), an increase of 20% (P = .284, 95% CI -11.54% to 51.4%). There was also a trend toward more appropriate use of nuclear cardiology following cardiac stress testing (63.0% vs 45.5%), an absolute increase of 17.5% (P =.400, 95% CI -13.9% to 48.9%). Referrals to cardiologists did not increase (38.2% with the PDA vs 40.9%, P =.869). A PDA-based software application can lead to improved care for patients with suspected angina seen in family practices; this finding requires confirmation in a larger study.

Xenon anaesthesia for patients undergoing off-pump coronary artery bypass graft surgery: a prospective randomized controlled pilot trial.

PubMed

Al Tmimi, L; Van Hemelrijck, J; Van de Velde, M; Sergeant, P; Meyns, B; Missant, C; Jochmans, I; Poesen, K; Coburn, M; Rex, S

2015-10-01

Off-pump coronary artery bypass (OPCAB) surgery carries a high risk for haemodynamic instability and perioperative organ injury. Favourable haemodynamic effects and organ-protective properties could render xenon an attractive anaesthetic for OPCAB surgery. The primary aim of this study was to assess whether xenon anaesthesia for OPCAB surgery is non-inferior to sevoflurane anaesthesia with regard to intraoperative vasopressor requirements. Forty-two patients undergoing elective OPCAB surgery were enrolled in this prospective, single-blind, randomized controlled pilot trial. Patients were randomized to either xenon (50-60 vol%) or sevoflurane (1.1-1.4 vol%) anaesthesia. Primary outcome was intraoperative noradrenaline requirements necessary to achieve predefined haemodynamic goals. Secondary outcomes included safety variables such as the occurrence of adverse events (intraoperatively and during a 6-month follow-up after surgery) and the perioperative cardiorespiratory and inflammatory profile. Baseline and intraoperative data did not differ between groups. Xenon was non-inferior to sevoflurane, as xenon patients required significantly less noradrenaline intraoperatively to achieve the predefined haemodynamic goals {geometric mean 428 [95% confidence interval (CI) 312, 588] vs 1702 [1267, 2285] µg, P<0.0001}. No differences were found for safety. Significantly more sevoflurane patients developed postoperative delirium (POD) (hazard ratio 4.2, P=0.044). The average arterial pressure was lower in the sevoflurane group {median75 [interquartile range (IQR) 6] vs 72 [4] mmHg, P=0.002}. No differences were found for other haemodynamic parameters, the respiratory profile and the perioperative release of inflammatory cytokines, troponin T, serum protein S-100β and erythropoietin. Compared with sevoflurane, xenon anaesthesia allows a significant reduction in vasopressor administration in OPCAB surgery. Moreover, xenon anaesthesia was associated with a lower risk for POD, a finding that has to be confirmed in larger studies. ClinicalTrials.gov (NCT01757106) and EudraCT (2012-002316-12). © The Author 2015. Published by Oxford University Press on behalf of the British Journal of Anaesthesia. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

A pilot study of neurointerventional research level of evidence and collaboration.

PubMed

Fargen, Kyle M; Mocco, J; Spiotta, Alejandro M; Rai, Ansaar; Hirsch, Joshua A

2017-07-01

No studies have sought to provide a quantitative or qualitative critique of research in the field of neurointerventional surgery. To analyze recent publications from the Journal of Neurointerventional Surgery ( JNIS ) to test a new method for assessing research and collaboration. We reviewed all JNIS Online First publications from 25 February 2015 to 24 February 2016. All publications-human or non-human research, systematic reviews, meta-analyses, or literature reviews-were included; editorials and commentaries were excluded. For each publication, study design, number of patients, authors, contributing centers, and study subject were recorded. Level of evidence was defined using a new scale. A total of 206 articles met inclusion criteria. Only 4% were prospective studies. Twenty-eight per cent of scientific research featured patient series of nine or less. The majority of publications were categorized as low-level evidence (91%). Forty-seven per cent involved individuals from a single center, with 87% having collaboration from three or fewer centers. International collaboration was present in 19%. While 256 institutions from 31 countries were represented, 66% were represented in only one publication. We queried JNIS Online First articles from a 1-year period in a pilot study to test a new method of analyzing research quality and collaboration. The methodology appears to adequately quantify the studies into evidence tiers that emulate previously published, widely accepted scales. This may be useful for future comparison of peer-reviewed journals or for studying the quality of research being performed in different disease processes or medical specialties. 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/.

Solid-state fermentation of soybean residues for bioflocculant production in a pilot-scale bioreactor system.

PubMed

Zulkeflee, Zufarzaana; Sánchez, Antoni

2014-01-01

An innovative approach using soybean residues for the production of bioflocculants through solid-state fermentation was carried out in 4.5 L near-to-adiabatic bioreactors at pilot-scale level. An added inoculum of the strain Bacillus subtilis UPMB13 was tested in comparison with control reactors without any inoculation after the thermophilic phase of the fermentation. The flocculating performances of the extracted bioflocculants were tested on kaolin suspensions, and crude bioflocculants were obtained from 20 g of fermented substrate through ethanol precipitation. The production of bioflocculants was observed to be higher during the death phase of microbial growth. The bioflocculants were observed to be granular in nature and consisted of hydroxyl, carboxyl and methoxyl groups that aid in their flocculating performance. The results show the vast potential of the idea of using wastes to produce bioactive materials that can replace the current dependence on chemicals, for future prospect in water treatment applications.

Short-term effects of teriparatide versus placebo on bone biomarkers, structure, and fracture healing in women with lower-extremity stress fractures: A pilot study.

PubMed

Almirol, Ellen A; Chi, Lisa Y; Khurana, Bharti; Hurwitz, Shelley; Bluman, Eric M; Chiodo, Christopher; Matzkin, Elizabeth; Baima, Jennifer; LeBoff, Meryl S

2016-09-01

In this pilot, placebo-controlled study, we evaluated whether brief administration of teriparatide (TPTD) in premenopausal women with lower-extremity stress fractures would increase markers of bone formation in advance of bone resorption, improve bone structure, and hasten fracture healing according to magnetic resonance imaging (MRI). Premenopausal women with acute lower-extremity stress fractures were randomized to injection of TPTD 20-µg subcutaneous (s.c.) (n = 6) or placebo s.c. (n = 7) for 8 weeks. Biomarkers for bone formation N-terminal propeptide of type I procollagen (P1NP) and osteocalcin (OC) and resorption collagen type-1 cross-linked C-telopeptide (CTX) and collagen type 1 cross-linked N-telopeptide (NTX) were measured at baseline, 4 and 8 weeks. The area between the percent change of P1NP and CTX over study duration is defined as the anabolic window. To assess structural changes, peripheral quantitative computed topography (pQCT) was measured at baseline, 8 and 12 weeks at the unaffected tibia and distal radius. The MRI of the affected bone assessed stress fracture healing at baseline and 8 weeks. After 8 weeks of treatment, bone biomarkers P1NP and OC increased more in the TPTD- versus placebo-treated group (both p ≤ 0.01), resulting in a marked anabolic window (p ≤ 0.05). Results from pQCT demonstrated that TPTD-treated women showed a larger cortical area and thickness compared to placebo at the weight bearing tibial site, while placebo-treated women had a greater total tibia and cortical density. No changes at the radial sites were observed between groups. According to MRI, 83.3% of the TPTD- and 57.1% of the placebo-treated group had improved or healed stress fractures (p = 0.18). In this randomized, pilot study, brief administration of TPTD showed anabolic effects that TPTD may help hasten fracture healing in premenopausal women with lower-extremity stress fractures. Larger prospective studies are warranted to determine the effects of TPTD treatment on stress fracture healing in premenopausal women.

Levosimendan versus milrinone in neonates and infants after corrective open-heart surgery: a pilot study.

PubMed

Lechner, Evelyn; Hofer, Anna; Leitner-Peneder, Gabriele; Freynschlag, Roland; Mair, Rudolf; Weinzettel, Robert; Rehak, Peter; Gombotz, Hans

2012-09-01

Low cardiac output syndrome commonly complicates the postoperative course after open-heart surgery in children. To prevent low cardiac output syndrome, prophylactic administration of milrinone after cardiopulmonary bypass is commonly used in small children. The aim of this study was to compare the effect of prophylactically administered levosimendan and milrinone on cardiac index in neonates and infants after corrective open-heart surgery. Prospective, single-center, double-blind, randomized pilot study. Tertiary care center, postoperative pediatric cardiac intensive care unit. After written informed consent, 40 infants undergoing corrective open-heart surgery were included. At weaning from cardiopulmonary bypass, either a 24-hr infusion of 0.1 μg/kg/min levosimendan or of 0.5 μg/kg/min milrinone were administered. Cardiac output was evaluated at 2, 6, 9, 12, 18, 24, and 48 hrs after cardiopulmonary bypass using a transesophageal Doppler technique (Cardio-QP, Deltex Medical, Chichester, UK). Cardiac index was calculated from cardiac output and the patients' respective body surface area. Intention-to-treat data of 39 patients (19 in the levosimendan and 20 in the milrinone group) were analyzed using analysis of variance for repeated measurements for statistics. Analysis of variance revealed for both, cardiac index and cardiac output, similar results with no significant differences of the factors group and time. A significant interaction for cardiac output (p = .005) and cardiac index (p = .007) was found, which indicates different time courses of cardiac index in the two groups. Both drugs were well tolerated; no death or serious adverse event occurred. In our small study, postoperative cardiac index over time was similar in patients with prophylactically administered levosimendan and patients with prophylactically given milrinone. We observed an increase in cardiac output and cardiac index over time in the levosimendan group, whereas cardiac output and cardiac index remained stable in the milrinone group. This pilot study has primarily served to obtain experience using the new drug levosimendan in neonates and infants and to initiate further multicenter trials in pediatric patients.

Health care providers' perspectives on a weekly text-messaging intervention to engage HIV-positive persons in care (WelTel BC1).

PubMed

Murray, Melanie C M; O'Shaughnessy, Sara; Smillie, Kirsten; Van Borek, Natasha; Graham, Rebecca; Maan, Evelyn J; van der Kop, Mia L; Friesen, Karen; Albert, Arianne; Levine, Sarah; Pick, Neora; Ogilvie, Gina; Money, Deborah; Lester, Richard

2015-10-01

Though evidence shows that Mobile health (mHealth) interventions can improve adherence and viral load in HIV-positive persons, few have studied the health care providers' (HCP) perspective. We conducted a prospective mixed methods pilot study using the WelTel intervention wherein HIV-positive participants (n = 25) received weekly interactive text messages for 6 months. Text message response rate and topic data were collected to illustrate the HCP experience. The aim of this study is to explore intervention acceptability and feasibility from the HCP perspective through a baseline focus group and end of study interviews with HCP impacted by the intervention. Interview data were thematically coded using the Technology Acceptance Model. HCPs identified that the WelTel intervention engaged patients in building relationships, while organizing and streamlining existing mHealth efforts and dealing with privacy issues. HCPs recognized that although workload would augment initially, intervention benefits were many, and went beyond simply improving HIV viral load.

[Academic application of text messages in a first aid course: a pilot study in a private university in Lima, Peru].

PubMed

Carrillo-Larco, Rodrigo M; Shu-Yip, Sebastián B; Pérez-Lu, José E

2015-01-01

The aim of the study was to develop and evaluate the impact of an educational intervention with the use of text messages (SMS) in a first aid course. A prospective study and intervention was conducted. Two steps were implemented: 1) a qualitative study to design the SMS and 2) the intervention with the sending of the SMS messages. The outcome variable was the final grade of students. Multivariate models were constructed, prevalence ratios and confidence intervals at 95% were calculated. The first phase revealed that the SMS should be educational-theoretical, motivational, and multiple choice. In the intervention there were 66 participants in the control and intervention group. The average age was 17.7 (± 1.2) years. The intervention group obtained higher scores compared with the control group (PR = 4.82; 95% CI: 1.58 to 14.72). In conclusion, SMS with informative and motivational content is useful in the formation of undergraduate medicine.

Cell therapy attempted as a novel approach for chronic traumatic brain injury - a pilot study.

PubMed

Sharma, Alok; Sane, Hemangi; Kulkarni, Pooja; Yadav, Jayanti; Gokulchandran, Nandini; Biju, Hema; Badhe, Prerna

2015-01-01

Traumatic brain injury is an injury to the brain parenchyma resulting from external factors such as vehicular accidents, falls, or sports injuries. Its outcome involves primary insult followed by a cascade of secondary insult, resulting in diffuse axonal injury further causing white matter damage. Surgical intervention targets the primary damage, whereas only few treatment alternatives are available to treat the secondary damage. Cellular therapy could be one of the prospective therapeutic options, as it has the potential to arrest the degeneration and promote regeneration of new cells in the brain. We conducted a pilot study on 14 cases who were administered with autologous bone marrow mononuclear cells, intrathecally. The follow up was done at 1 week, 3 months and 6 months after the intervention. The Functional Independence Measure scale, the SF-8 Health Survey Scoring and the disability rating scale were used as outcome measures. These scales showed a positive shift in scores at the end of 6 months. Improvements were observed in various symptoms, along with activities of daily living. Improvement in PET CT scan performed before and 6 months after the intervention in 3 patients corresponded to the clinical and functional improvements observed in these patients. The results of this study suggest that cell therapy may promote functional recovery leading to an improved quality of life in chronic TBI. Although the results are positive, the improvements after cell therapy are not optimal. Hence, additional multicenter, controlled studies are required to establish cell therapy as a standard therapeutic approach.

Female pattern hair loss: a pilot study investigating combination therapy with low-dose oral minoxidil and spironolactone.

PubMed

Sinclair, Rodney D

2018-01-01

Minoxidil and spironolactone are oral antihypertensives known to stimulate hair growth. To report on a case series of women with pattern hair loss (PHL) treated with once daily minoxidil 0.25 mg and spironolactone 25 mg. Women newly diagnosed with a Sinclair stage 2-5 PHL were scored for hair shedding and hair density before and after 12 months of treatment with oral minoxidil 0.25 mg and spironolactone 25 mg. A total of 100 women were included in this observational pilot study. Mean age was 48.44 years (range 18-80). Mean hair loss severity at baseline was Sinclair 2.79 (range 2-5). Mean hair shedding score at baseline was 4.82. Mean duration of diagnosis was 6.5 years (range 0.5-30). Mean reduction in hair loss severity score was 0.85 at 6 months and 1.3 at 12 months. Mean reduction in hair shedding score was 2.3 at 6 months and 2.6 at 12 months. Mean change in blood pressure was -4.52 mmHg systolic and -6.48 mmHg diastolic. Side effects were seen in eight women but were generally mild. No patients developed hyperkalemia or any other blood test abnormality. Six of these women continued treatment, and two women who developed urticaria discontinued treatment. Prospective, uncontrolled, open-label observational study. Once daily capsules containing minoxidil 0.25 mg and spironolactone 25 mg appear to be safe and effective in the treatment of FPHL. Placebo-controlled studies to investigate this further are warranted. © 2017 The International Society of Dermatology.

Physical activity and pelvic floor muscle training in patients with pelvic organ prolapse: a pilot study.

PubMed

Ouchi, Mifuka; Kato, Kumiko; Gotoh, Momokazu; Suzuki, Shigeyuki

2017-12-01

The details of the physical activity in patients with mild to moderate pelvic organ prolapse (Pmoderate pelvic organ prolapse (POP) remain under-studied. The purpose of the present study was to investigate objective physical activity levels and the changes in pelvic floor muscle(PFM) strength, symptoms and quality of life (QOL) between before and after PFM training (PFMT) in patients with POP. In a prospective pilot study, 29 patients with stage II or III POP completed approximately 16 weeks of PFMT. A reliable activity monitor was used to measure physical activity parameters including step counts, activity and total calories expended, and duration at each intensity level. Maximum vaginal squeeze pressure, POP symptoms and QOL were assessed. Changes in these outcome measures were compared before and after PFMT. The step counts per day (mean ± SD) of women with POP was 7,272.9 ± 3,091.7 before PFMT and 7,553.4 ± 2,831.0 after PFMT. There was no significant change between before and PFMT. PFM strength was significantly increased after PFMT. POP-related symptoms including stress urinary incontinence, frequency, postmicturition dribble and interference with emptying the bowels were significantly improved. The QOL scores for general health, physical limitations, emotion, and severity measures were significantly improved after PFMT. Although PFMT changed PFM strength symptoms, and QOL, there were no changes for any physical activity parameters before and after PFMT. This is probably because the physical activity levels in patients with mild to moderate POP were almost same as in age-matched healthy women.

The efficacy of vitamin K2 and calcitriol combination on thalassemic osteopathy.

PubMed

Ozdemir, Mehmet A; Yilmaz, Kenan; Abdulrezzak, Ummuhan; Muhtaroglu, Sebahattin; Patiroglu, Turkan; Karakukcu, Musa; Unal, Ekrem

2013-11-01

Thalassemic osteopathy (TOSP) has emerged as a topic of interest, as the optimized transfusion regimens and iron chelations has markedly improved the survival of the patients suffering from thalassemia major (TM) and increased the life expectancy. The aim of this prospective monocentric pilot study was to investigate the effects of a dietary supplement with vitamin K2 (50 mcg menaquinone-7) and vitamin D (5 mcg calcitriol) on the patients with TOSP. Twenty children (12 girls, 8 boys; age varied from 3 to 18 y) with β TM, who underwent regular blood transfusion and iron chelation therapy, were enrolled in this study and investigated at the initial, sixth, and 12th month of the treatment. We detected a significant improvement in the bone mineral density and Z-score at the lumbar spine area of the patients at the sixth and 12th month of the treatment, especially in the prepubertal group. We also found a decrease in the ratio of undercarboxylated osteocalcin to carboxylated osteocalcin, however, this was not found to be significant. Although the natural course of TOSP is worsening or at least stabilizing, our pilot study demonstrated that vitamin K2 and calcitriol combination clearly has a positive effect on the bone mineral density of the children with TM during a 1-year period. Supplementation of menaquinone-7 instead of drugs is an augmented physiological intake and seems a beneficial alternative for the treatment of TOSP. Further studies on a large number of participants are necessary to highlight the effect of vitamin K2 on TOSP.

A Pilot Study of Augmented Reality Technology Applied to the Acetabular Cup Placement During Total Hip Arthroplasty.

PubMed

Ogawa, Hiroyuki; Hasegawa, Seiichirou; Tsukada, Sachiyuki; Matsubara, Masaaki

2018-06-01

We developed an acetabular cup placement device, the AR-HIP system, using augmented reality (AR). The AR-HIP system allows the surgeon to view an acetabular cup image superimposed in the surgical field through a smartphone. The smartphone also shows the placement angle of the acetabular cup. This preliminary study was performed to assess the accuracy of the AR-HIP system for acetabular cup placement during total hip arthroplasty (THA). We prospectively measured the placement angles using both a goniometer and AR-HIP system in 56 hips of 54 patients undergoing primary THA. We randomly determined the order of intraoperative measurement using the 2 devices. At 3 months after THA, the placement angle of the acetabular cup was measured on computed tomography images. The primary outcome was the absolute value of the difference between intraoperative and postoperative computed tomography measurements. The measurement angle using AR-HIP was significantly more accurate in terms of radiographic anteversion than that using a goniometer (2.7° vs 6.8°, respectively; mean difference 4.1°; 95% confidence interval, 3.0-5.2; P < .0001). There was no statistically significant difference in terms of radiographic inclination (2.1° vs 2.6°; mean difference 0.5°; 95% confidence interval, -1.1 to 0.1; P = .13). In this pilot study, the AR-HIP system provided more accurate information regarding acetabular cup placement angle than the conventional method. Further studies are required to confirm the utility of the AR-HIP system as a navigation tool. Copyright © 2018 Elsevier Inc. All rights reserved.

Balloon Dilation of the Cartilaginous Portion of the Eustachian Tube.

PubMed

Silvola, Juha; Kivekäs, Ilkka; Poe, Dennis S

2014-07-01

Studies of balloon Eustachian tuboplasty (BET) have shown encouraging results in small series with short follow-ups. Our pilot study suggested that patients with protracted otitis media with effusion (OME) or atelectasis of the tympanic membrane (TM) could benefit from BET. A prospective study where subjects act as their own controls. Patients from the pilot study and additional cases were enrolled in this cohort with long-term follow-up. Regional Academic Center. Out of 80 patients who underwent BET, 41 consecutive Eustachian tube (ET) operations were included. Subjects' inclusion criteria were OME and/or TM atelectasis, type B or C tympanograms, and inability to inflate their middle ears by Valsalva maneuver. All patients had longstanding ET dysfunction relieved only by repeated tympanostomies. Outcomes included ability to perform a Valsalva maneuver, audiometry, tympanometry, videoendoscopy of the ET with mucosal inflammation rating scores, and otomicroscopy. All cases were dilated successfully, without significant complications. Mean follow-up was 2.5 years (range, 1.5-4.2 years). Eighty percent (33/41) could do a Valsalva maneuver postoperatively; none of these ears required new tympanostomy tubes and subjective symptoms were relieved. Tympanometry results showed overall improvement. Nine patients had persistent perforations and 3 declined removal of the tube. Subjective symptoms were not relieved for 10% (4/41). The results show that BET can effectively improve ET function in ears with OME or atelectasis. The procedure is well tolerated and without significant complications. The follow-up continues and we are investigating possible reasons for failures. © American Academy of Otolaryngology—Head and Neck Surgery Foundation 2014.

Sleep Quantity and Quality during Acute Concussion: A Pilot Study.

PubMed

Raikes, Adam C; Schaefer, Sydney Y

2016-12-01

A number of subjective and objective studies provide compelling evidence of chronic post-concussion changes in sleep, yet very little is known about the acute effects of concussion on sleep quality and quantity. Therefore, the purpose of this prospective pilot study was to use actigraphy to examine the changes in sleep quality and quantity acutely following concussion at home rather than in a hospital or sleep laboratory. Seventeen young adults (7 with acute concussion, 10 controls) were recruited for this study. All participants completed two 5-day testing sessions separated by 30 days from intake (controls) or day of injury (concussion). Participants wore actigraphs and kept a sleep journal. Sleep parameter outcomes included nighttime total sleep time (nTST), 24-h total sleep time (TST), wake after sleep onset (WASO), and sleep efficiency (SE). The coefficient of variation (CV) for each sleep parameter was computed for each session. nTST and TST CV was significantly greater in the concussion group. There is the additional indication that individuals with a concussion may require and obtain more sleep shortly after injury and subsequently have a shorter duration of sleep at 1 mo post-injury. This pattern was not seen in the measures of sleep quality (WASO, SE). Individuals with a concussion demonstrated increased nighttime sleep duration variability. This increase persisted at 1 mo post-injury and may be associated with previously documented self-reports of poor sleep quality lasting months and years after a concussion. Additionally, this increase may predispose individuals to numerous negative health outcomes if left untreated. © 2016 Associated Professional Sleep Societies, LLC.

Serum chemerin levels are independently associated with quality of life in colorectal cancer survivors: A pilot study

PubMed Central

Lee, Jee-Yon; Lee, Mi-Kyung; Kim, Nam-Kyu; Chu, Sang-Hui; Lee, Duk-Chul; Lee, Hye-Sun

2017-01-01

Background Colorectal cancer (CRC) survivors are known to experience various symptoms that significantly affect their quality of life (QOL); therefore, it is important to identify clinical markers related with CRC survivor QOL. Here we investigated the relationship between serum chemerin levels, a newly identified proinflammatory adipokine, and QOL in CRC survivors. Methods A data of total of 110 CRC survivors were analysed in the study. Serum chemerin levels were measured with an enzyme immunoassay analyser. Functional Assessment of Cancer Therapy (FACT) scores were used as an indicator of QOL in CRC survivors. Results Weak but not negligible relationships were observed between serum chemerin levels and FACT-General (G) (r = -0.22, p<0.02), FACT-Colorectal cancer (C) (r = -0.23, p<0.02) and FACT-Fatigue (F) scores (r = -0.27, p<0.01) after adjusting for confounding factors. Both stepwise and enter method multiple linear regression analyses confirmed that serum chemerin levels were independently associated with FACT-G (stepwise: β = -0.15, p<0.01; enter: β = -0.12, p = 0.02), FACT-C (stepwise: β = -0.19, p<0.01; enter; β = -0.14, p = 0.02) and FACT-F scores (stepwise: β = -0.23, p<0.01; enter: β = -0.20, p<0.01). Conclusions Our results demonstrate a weak inverse relationship between serum chemerin and CRC survivor QOL. Although it is impossible to determine causality, our findings suggest that serum chemerin levels may have a significant association with CRC survivor QOL. Further prospective studies are required to confirm the clinical significance of our pilot study. PMID:28475614

Patient-specific rehearsal prior to EVAR: a pilot study.

PubMed

Desender, L; Rancic, Z; Aggarwal, R; Duchateau, J; Glenck, M; Lachat, M; Vermassen, F; Van Herzeele, I

2013-06-01

This study aims to evaluate feasibility, face validity, influence on technical factors and subjective sense of utility of patient-specific rehearsal (PsR) prior to endovascular aortic aneurysm repair (EVAR). A prospective, multicentre pilot study. Patients suitable for EVAR were enrolled and a three-dimensional (3D) model of the patient's anatomy was generated. Less than 24 h prior to the real case, rehearsals were conducted in the laboratory or clinical angiosuite. Technical metrics were recorded during both procedures. A subjective questionnaire was used to evaluate realism, technical and human factor aspects (scale 1-5). Ten patients were enrolled. In one case, the treatment plan was altered based on PsR. In 7/9 patients, the rehearsal significantly altered the optimal C-arm position for the proximal landing zone and an identical fluoroscopy angle was chosen in the real procedure. All team members found the rehearsal useful for selecting the optimal fluoroscopy angle (median 4). The realism of the EVAR procedure simulation was rated highly (median 4). All team members found the PsR useful to prepare the individual team members and the entire team (median 4). PsR for EVAR permits creation of realistic case studies. Subjective evaluation indicates that it may influence optimal C-arm angles and be valuable to prepare the entire team. A randomised controlled trial (RCT) is planned to evaluate how this technology may influence technical and team performance, ultimately leading to improved patient safety. Copyright © 2013 European Society for Vascular Surgery. Published by Elsevier Ltd. All rights reserved.

Pilot study of dornase alfa (Pulmozyme) therapy for acquired ventilator-associated infection in preterm infants.

PubMed

Scala, Melissa; Hoy, Deborah; Bautista, Maria; Palafoutas, Judith Jones; Abubakar, Kabir

2017-06-01

Evaluate the feasibility, safety, and efficacy of adjunctive treatment with dornase alfa in preterm patients with ventilator-associated pulmonary infection (VAPI) compared to standard care. We hypothesize that therapy with dornase alfa will be safe and well tolerated in the preterm population with no worsening of symptoms, oxygen requirement, or need for respiratory support. Prospective, randomized, blinded, pilot study comparing adjunctive treatment with dornase alfa to sham therapy. In addition to standard care, infants were randomized to receive dornase alfa 2.5 mg nebulized via endotracheal tube (ETT) every 12 hr for 7 days or sham therapy. ETT secretion gram stain and culture and chest X-ray (CXR) findings were evaluated. Respiratory support data were downloaded from the ventilator. Fourteen infants developed VAPI between 2012 and 2014; 11 enrolled in the study. Six received dornase alfa and five received sham therapy. Average gestational age at birth was 25 weeks and age at study entry was 31 days. There were no differences in demographics, ETT white blood cell count (WBC), CXR, or mean airway pressure (MAP) between the two groups. There was a trend towards decreased oxygen requirement (FiO2) in the treatment group that did not reach statistical significance. No side effects were observed in the treatment group. Treatment with dornase alfa is safe and treated infants had some improvement in FiO 2 requirement but no improvement in MAP. A larger randomized trial is needed to evaluate the efficacy of this therapy. Pediatr Pulmonol. 2017; 52:787-791. © 2017 Wiley Periodicals, Inc. © 2017 Wiley Periodicals, Inc.

Intraoperative Cochlear Implant Device Testing Utilizing an Automated Remote System: A Prospective Pilot Study.

PubMed

Lohmann, Amanda R; Carlson, Matthew L; Sladen, Douglas P

2018-03-01

Intraoperative cochlear implant device testing provides valuable information regarding device integrity, electrode position, and may assist with determining initial stimulation settings. Manual intraoperative device testing during cochlear implantation requires the time and expertise of a trained audiologist. The purpose of the current study is to investigate the feasibility of using automated remote intraoperative cochlear implant reverse telemetry testing as an alternative to standard testing. Prospective pilot study evaluating intraoperative remote automated impedance and Automatic Neural Response Telemetry (AutoNRT) testing in 34 consecutive cochlear implant surgeries using the Intraoperative Remote Assistant (Cochlear Nucleus CR120). In all cases, remote intraoperative device testing was performed by trained operating room staff. A comparison was made to the "gold standard" of manual testing by an experienced cochlear implant audiologist. Electrode position and absence of tip fold-over was confirmed using plain film x-ray. Automated remote reverse telemetry testing was successfully completed in all patients. Intraoperative x-ray demonstrated normal electrode position without tip fold-over. Average impedance values were significantly higher using standard testing versus CR120 remote testing (standard mean 10.7 kΩ, SD 1.2 vs. CR120 mean 7.5 kΩ, SD 0.7, p < 0.001). There was strong agreement between standard manual testing and remote automated testing with regard to the presence of open or short circuits along the array. There were, however, two cases in which standard testing identified an open circuit, when CR120 testing showed the circuit to be closed. Neural responses were successfully obtained in all patients using both systems. There was no difference in basal electrode responses (standard mean 195.0 μV, SD 14.10 vs. CR120 194.5 μV, SD 14.23; p = 0.7814); however, more favorable (lower μV amplitude) results were obtained with the remote automated system in the apical 10 electrodes (standard 185.4 μV, SD 11.69 vs. CR120 177.0 μV, SD 11.57; p value < 0.001). These preliminary data demonstrate that intraoperative cochlear implant device testing using a remote automated system is feasible. This system may be useful for cochlear implant programs with limited audiology support or for programs looking to streamline intraoperative device testing protocols. Future studies with larger patient enrollment are required to validate these promising, but preliminary, findings.

Animal Study Registries: Results from a Stakeholder Analysis on Potential Strengths, Weaknesses, Facilitators, and Barriers.

PubMed

Wieschowski, Susanne; Silva, Diego S; Strech, Daniel

2016-11-01

Publication bias in animal research, its extent, its predictors, and its potential countermeasures are increasingly discussed. Recent reports and conferences highlight the potential strengths of animal study registries (ASRs) in this regard. Others have warned that prospective registration of animal studies could diminish creativity, add administrative burdens, and complicate intellectual property issues in translational research. A literature review and 21 international key-informant interviews were conducted and thematically analyzed to develop a comprehensive matrix of main- and subcategories for potential ASR-related strengths, weaknesses, facilitators, and barriers (SWFBs). We identified 130 potential SWFBs. All stakeholder groups agreed that ASRs could in various ways improve the quality and refinement of animal studies while allowing their number to be reduced, as well as supporting meta-research on animal studies. However, all stakeholder groups also highlighted the potential for theft of ideas, higher administrative burdens, and reduced creativity and serendipity in animal studies. Much more detailed reasoning was captured in the interviews than is currently found in the literature, providing a comprehensive account of the issues and arguments around ASRs. All stakeholder groups highlighted compelling potential strengths of ASRs. Although substantial weaknesses and implementation barriers were highlighted as well, different governance measures might help to minimize or even eliminate their impact. Such measures might include confidentiality time frames for accessing prospectively registered protocols, harmonized reporting requirements across ASRs, ethics reviews, lab notebooks, and journal submissions. The comprehensive information gathered in this study could help to guide a more evidence-based debate and to design pilot tests for ASRs.

Effective symptomatic treatment for severe and intractable pruritus associated with severe burn-induced hypertrophic scars: A prospective, multicenter, controlled trial.

PubMed

Wu, Jun; Xu, Rui; Zhan, Rixing; Luo, Gaoxing; Niu, Xihua; Liu, Yi; Lee, Benjamin Tak-Kwong; Flury, Meinrad; Wong, Chun-Ho; Fok, Manson; Lau, Johnson Yiu-Nam

2016-08-01

Burn-induced hypertrophic scars are disfiguring and can be associated with severe and intractable pruritus. No effective treatment modalities are currently available for symptomatic control of pruritus for most patients. We assessed the effect of the Antipruritic Hydrogel (CQ-01) in the symptomatic treatment of severe and intractable pruritus associated with burn-induced hypertrophic scars in a prospective, multicenter, controlled trial. A pilot study was conducted in healthy adult volunteers to identify the most appropriate hydrogel formulation. A selected preparation called Chongqing No. 1 (CQ-01; a guar gum-based hydrogel impregnated with peppermint oil, menthol, and methyl salicylate by a nanoemulsion), showed an excellent symptomatic relief in an exploratory study in 2 patients with intractable pruritus. A statistically powered, prospective, multicenter, controlled study was then conducted in 74 patients to evaluate the efficacy and safety of a 24-h application of CQ-01 compared to a gel control and a negative control on three separate areas in each patient. Symptom assessment was based on our visual analog JW scale (ranging from 0 to 100) at baseline and various time points up to 7 days after application. Follow-up studies were conducted to determine the reproducibility of CQ-01 in repeated applications. Of the 74 enrolled subjects, the only observed adverse event was skin irritation reported in 6 patients (8%) and resolved shortly after gel removal. Compared to the baseline, the gauze negative control had a mean JW score reduction of 7; while the gel control and CQ-01 had a drop of 18 (p<0.001) and 36 (p<0.001), respectively. The CQ-01 clinical effect was significant for up to 3 days and waned slowly from 3 to 7 days. There was no statistical correlation between the treatment response and any of the demographic, patient or burn-related factors. Further studies showed a trend that repeated applications might be more effective, suggesting the absence of tachyphylaxis. This prospective, multicenter, controlled study showed that this novel hydrogel CQ-01 is safe and provides significant symptomatic relief for severe and intractable pruritus associated with hypertrophic scars, an unmet medical need for these patients. This effect is independent of the etiology of the burn trauma, extent of the scarring, and duration of the scar formation. Copyright © 2016. Published by Elsevier Ltd.

Pilot-model analysis and simulation study of effect of control task desired control response

NASA Technical Reports Server (NTRS)

Adams, J. J.; Gera, J.; Jaudon, J. B.

1978-01-01

A pilot model analysis was performed that relates pilot control compensation, pilot aircraft system response, and aircraft response characteristics for longitudinal control. The results show that a higher aircraft short period frequency is required to achieve superior pilot aircraft system response in an altitude control task than is required in an attitude control task. These results were confirmed by a simulation study of target tracking. It was concluded that the pilot model analysis provides a theoretical basis for determining the effect of control task on pilot opinions.

Greater hunger and less restraint predict weight loss success with phentermine treatment

PubMed Central

Thomas, Elizabeth A.; McNair, Bryan; Bechtell, Jamie L.; Ferland, Annie; Cornier, Marc-Andre; Eckel, Robert H.

2015-01-01

Objective Phentermine is thought to cause weight loss through a reduction in hunger. We hypothesized that higher hunger ratings would predict greater weight loss with phentermine. Design and Methods This is an observational pilot study in which all subjects were treated with phentermine for 8 weeks and appetite and eating behaviors were measured at baseline and week 8. Outcomes were compared in subjects with ≥5% vs <5% weight loss, and linear regression was used to identify predictors of percent weight loss. Results 27 subjects (37 ± 4.5 yrs, 93.8 ± 12.1 kg, BMI 33.8 ± 3.1 kg/m2) completed the study, with mean weight loss of -5.4 ± 3.3 kg (-5.7 ± 3.2%). Subjects with ≥5% weight loss had higher baseline pre-breakfast hunger (p=0.017), desire to eat (p=0.003), and prospective food consumption (0.006), and lower baseline cognitive restraint (p=0.01). In addition, higher baseline home prospective food consumption (p=0.002) and lower baseline cognitive restraint (p<0.001) were found to be predictors of weight loss. Conclusion These results suggest that individuals reporting greater hunger and less restraint are more likely to achieve significant weight loss with phentermine. This information can be used clinically to determine who might benefit most from phentermine treatment. PMID:26584649

Greater hunger and less restraint predict weight loss success with phentermine treatment.

PubMed

Thomas, Elizabeth A; Mcnair, Bryan; Bechtell, Jamie L; Ferland, Annie; Cornier, Marc-Andre; Eckel, Robert H

2016-01-01

Phentermine is thought to cause weight loss through a reduction in hunger. It was hypothesized that higher hunger ratings would predict greater weight loss with phentermine. This is an observational pilot study in which all subjects were treated with phentermine for 8 weeks and appetite and eating behaviors were measured at baseline and week 8. Outcomes were compared in subjects with ≥5% vs. <5% weight loss, and linear regression was used to identify predictors of percent weight loss. Twenty-seven subjects (37 ± 4.5 years, 93.8 ± 12.1 kg, BMI 33.8 ± 3.1 kg m(-2) ) completed the study, with mean weight loss of -5.4 ± 3.3 kg (-5.7% ± 3.2%). Subjects with ≥5% weight loss had higher baseline pre-breakfast hunger (P = 0.017), desire to eat (P =0.003), and prospective food consumption (0.006) and lower baseline cognitive restraint (P = 0.01). In addition, higher baseline home prospective food consumption (P = 0.002) and lower baseline cognitive restraint (P < 0.001) were found to be predictors of weight loss. These results suggest that individuals reporting greater hunger and less restraint are more likely to achieve significant weight loss with phentermine. This information can be used clinically to determine who might benefit most from phentermine treatment. © 2015 The Obesity Society.

The association between Myers-Briggs Type Indicator and Psychiatry as the specialty choice.

PubMed

Yang, Chong; Richard, George; Durkin, Martin

2016-02-06

The purpose of this pilot study is to examine the association between Myers-Briggs Type Indicator (MBTI) and prospective psychiatry residents. Forty-six American medical schools were contacted and asked to participate in this study. Data were collected and an aggregated list was compiled that included the following information: date of MBTI administration, academic year, MBTI form/version, residency match information and student demographic information. The data includes 835 American medical students who completed the MBTI survey and matched into a residency training program in the United States. All analyses were performed using R 3.1.2. The probability of an introvert matching to a psychiatry residency is no different than that of an extravert (p= 0.30). The probability of an intuitive individual matching to a psychiatry residency is no different than that of a sensing type (p=0.20). The probability of a feeling type matching to a psychiatry residency is no different than that of a thinking type (p= 0.50). The probability of a perceiving type matching to a psychiatry residency is no different than that of a judging type (p= 0.60). Further analyses may elicit more accurate information regarding the personality profile of prospective psychiatry residents. The improvement in communication, team dynamics, mentor-mentee relationships and reduction in workplace conflicts are possible with the awareness of MBTI personality profiles.

Neuropsychological outcomes after Gamma Knife radiosurgery for mesial temporal lobe epilepsy: a prospective multicenter study.

PubMed

Quigg, Mark; Broshek, Donna K; Barbaro, Nicholas M; Ward, Mariann M; Laxer, Kenneth D; Yan, Guofen; Lamborn, Kathleen

2011-05-01

To assess outcomes of language, verbal memory, cognitive efficiency and mental flexibility, mood, and quality of life (QOL) in a prospective, multicenter pilot study of Gamma Knife radiosurgery (RS) for mesial temporal lobe epilepsy (MTLE). RS, randomized to 20 Gy or 24 Gy comprising 5.5-7.5 ml at the 50% isodose volume, was performed on mesial temporal structures of patients with unilateral MTLE. Neuropsychological evaluations were performed at preoperative baseline, and mean change scores were described at 12 and 24 months postoperatively. QOL data were also available at 36 months. Thirty patients were treated and 26 were available for the final 24-month neuropsychological evaluation. Language (Boston Naming Test), verbal memory (California Verbal Learning Test and Logical Memory subtest of the Wechsler Memory Scale-Revised), cognitive efficiency and mental flexibility (Trail Making Test), and mood (Beck Depression Inventory) did not differ from baseline. QOL scores improved at 24 and 36 months, with those patients attaining seizure remission by month 24s accounting for the majority of the improvement. The serial changes in cognitive outcomes, mood, and QOL are unremarkable following RS for MTLE. RS may provide an alternative to open surgery, especially in those patients at risk of cognitive impairment or who desire a noninvasive alternative to open surgery. Wiley Periodicals, Inc. © 2011 International League Against Epilepsy.

The association between Myers-Briggs Type Indicator and Psychiatry as the specialty choice

PubMed Central

Richard, George; Durkin, Martin

2016-01-01

Objectives The purpose of this pilot study is to examine the association between Myers-Briggs Type Indicator (MBTI) and prospective psychiatry residents. Methods Forty-six American medical schools were contacted and asked to participate in this study. Data were collected and an aggregated list was compiled that included the following information: date of MBTI administration, academic year, MBTI form/version, residency match information and student demographic information. The data includes 835 American medical students who completed the MBTI survey and matched into a residency training program in the United States. All analyses were performed using R 3.1.2. Results The probability of an introvert matching to a psychiatry residency is no different than that of an extravert (p= 0.30). The probability of an intuitive individual matching to a psychiatry residency is no different than that of a sensing type (p=0.20). The probability of a feeling type matching to a psychiatry residency is no different than that of a thinking type (p= 0.50). The probability of a perceiving type matching to a psychiatry residency is no different than that of a judging type (p= 0.60). Conclusions Further analyses may elicit more accurate information regarding the personality profile of prospective psychiatry residents. The improvement in communication, team dynamics, mentor-mentee relationships and reduction in workplace conflicts are possible with the awareness of MBTI personality profiles. PMID:26851600

Cross-border reproductive care in North America: a pilot study testing a prospective data collection program for in vitro fertilization clinics in Canada and the United States.

PubMed

Hughes, Edward G; Sawyer, Angie; DeJean, Deirdre; Adamson, G David

2016-03-01

To develop and test a nonidentifying prospective data collection system for cross-border reproductive care (CBRC) in Canada and the United States (U.S.). Survey and cross-sectional study. Fertility clinics. Women traveling to and from Canada and the U.S. for reproductive care. None. Patients' home country, reason for crossing borders, and type of care received. Of 32 Canadian and 440 U.S. clinics contacted, seven and 46, respectively, responded to the initial questionnaire. Three out of seven Canadian and 44 out of 46 U.S. clinics reported providing CBRC. Seventy five percent agreed that nonidentifying data on country of origin and reason for travel should be collected. However, only one of seven Canadian and none of 46 U.S. clinics that expressed initial interest actually collected data, despite multiple communications. Although CBRC is a major component of assisted reproductive technology in North America (3%-10% of IVF cycles are provided to out-of-country patients in Canada and the U.S.), clinicians are not motivated to collect the simplest of data regarding CBRC patients. Despite this, reliable data are needed to help better understand the reasons for and impact of CBRC. Copyright © 2016 American Society for Reproductive Medicine. Published by Elsevier Inc. All rights reserved.

Emotional impact of severe post-partum haemorrhage on women and their partners: an observational, case-matched, prospective, single-centre pilot study.

PubMed

Ricbourg, Aude; Gosme, Christelle; Gayat, Etienne; Ventre, Chloé; Barranger, Emmanuel; Mebazaa, Alexandre

2015-10-01

This observational, matched-control, prospective, single-centre study sought to estimate the emotional impact of post-partum haemorrhage (PPH) on women and their partners, including its influences on post-traumatic stress disorder (PTSD), postpartum depression and the mother/child relationship. All consecutive women who were admitted for PPH from December 2010 through December 2011 and their partners were screened for eligibility. Emotional impact was assessed using three self-reported questionnaires (Impact of Event Scale-Revised to assess PTSD, Edinburgh Post Natal Depression Scale to assess post-natal depression and Mother-Infant Bonding Scale to assess the relationship between mother and child). Each PPH patient was matched with a control woman for whom the delivery was not complicated by PPH. The results showed (a) that women with PPH and their partners were more likely to report symptoms related to PTSD compared with controls, (b) that women with PPH were less likely to suffer from postnatal depression and (c) that there was no difference in the mother/child relationship between women with PPH and controls. PPH is associated with a high incidence of PTSD-related symptoms in both women and their partners. PTSD in the context of PPH is likely an under-recognised phenomenon by health care professionals. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.

INTRAVITREAL DEXAMETHASONE IMPLANT AS ADJUVANT TREATMENT FOR BEVACIZUMAB- AND RANIBIZUMAB-RESISTANT NEOVASCULAR AGE-RELATED MACULAR DEGENERATION: A Prospective Pilot Study.

PubMed

Barikian, Anita; Salti, Haytham; Safar, Ammar; Mahfoud, Ziyad R; Bashshur, Ziad F

2017-07-01

To study the benefit of intravitreal dexamethasone implant in the management of neovascular age-related macular degeneration resistant to bevacizumab and ranibizumab. Patients with persistent macular fluid on optical coherence tomography despite monthly treatment with at least three consecutive bevacizumab injections followed by at least three ranibizumab injections were prospectively enrolled. A single dexamethasone implant was administered followed by intravitreal ranibizumab 1 week later. Ranibizumab was continued afterward on an as-needed basis. Main outcomes were improvement in central retinal thickness and best-corrected visual acuity. Nineteen patients (19 eyes) were enrolled. There was no significant change in best-corrected visual acuity over 6 months. Greatest reduction in mean central retinal thickness, from 295.2 μm to 236.2 μm, occurred 1 month after dexamethasone implant (P < 0.0001). By Month 6, mean central retinal thickness was 287.3 μm (P = 0.16). Eyes with only intraretinal fluid (13 eyes) achieved a fluid-free macula. Eyes with predominantly subretinal fluid (6 eyes) did not improve central retinal thickness and continued monthly ranibizumab. Mean baseline intraocular pressure was 13.2 mmHg, which peaked at 15.6 mmHg by Month 2 (P = 0.004). Intravitreal dexamethasone implant improved only macular intraretinal fluid in eyes with neovascular age-related macular degeneration resistant to bevacizumab and ranibizumab. However, this treatment had a limited duration.

Treatment of dogs with compensated myxomatous mitral valve disease with spironolactone-a pilot study.

PubMed

Hezzell, M J; Boswood, A; López-Alvarez, J; Lötter, N; Elliott, J

2017-08-01

Spironolactone improves outcome in dogs with advanced myxomatous mitral valve disease (MMVD). Its efficacy in preclinical MMVD is unknown. The hypothesis was the administration of spironolactone to dogs with compensated MMVD demonstrating risk factors for poorer prognosis will decrease the rate of disease progression. The aim was to provide pilot data to evaluate preliminary effects and sample size calculation for a definitive clinical trial. Twenty-five client-owned dogs with MMVD with at least one of the following; left atrial to aortic ratio (LA:Ao) ≥ 1.5, normalized left ventricular internal diameter in diastole ≥ 1.6), N-terminal pro-B-type natriuretic peptide (NT-proBNP) > 550 pmol/L, cardiac troponin I > 0.025 ng/mL. Prospective, single-center, equally randomized, placebo-controlled, double-blinded, parallel grouped pilot study. No dogs were receiving medications for cardiac disease before the enrollment. Twelve dogs received placebo; 13 received spironolactone. One dog in the spironolactone group died suddenly, 1 developed congestive heart failure, and 2 received suboptimal spironolactone doses. At enrollment, NT-proBNP was significantly higher in the spironolactone group (p=0.005). Left atrial to aortic ratio (p=0.002) and left ventricular internal diameter in diastole (p=0.005) increased over time in the placebo group, but not the spironolactone group; the change did not differ significantly between groups. The change in biomarker concentrations did not differ significantly between groups; there was a tendency toward an increase in NT-proBNP over time in the placebo group. Enrollment of 76 dogs would be necessary to demonstrate a difference in the change in LA:Ao over 6 months between the groups. Preliminary results support undertaking a larger clinical trial of treatment of dogs with preclinical MMVD with spironolactone. Copyright © 2017 Elsevier B.V. All rights reserved.

The Decisions, Interventions, and Goals in ImplaNtable Cardioverter-DefIbrillator TherapY (DIGNITY) Pilot Study.

PubMed

Kramer, Daniel B; Habtemariam, Daniel; Adjei-Poku, Yaw; Samuel, Michelle; Engorn, Diane; Reynolds, Matthew R; Mitchell, Susan L

2017-09-22

Implantable cardioverter-defibrillators (ICDs) are commonly implanted in older patients, including those with multiple comorbidities. There are few prospective studies assessing the clinical course and end-of-life circumstances for these patients. We prospectively followed 51 patients with ICDs for up to 18 months to longitudinally assess in terms of (1) advance care planning, (2) health status, (3) healthcare utilization, and (4) end-of-life circumstances through quarterly phone interviews and electronic medical record review. The mean age was 71.1±8.3, 74.5% were men, and 19.6% were non-white. Congestive heart failure was predominant (82.4%), as was chronic kidney disease (92%). At baseline, a total of 12% of subjects met criteria for major depression, and 78.4% met criteria for mild cognitive impairment. From this initial study cohort, 76% survived to 18 months and completed all follow-up interviews, 18% died, and 19% withdrew or were lost to follow-up. Though living will completion and healthcare proxy assignment were common (cumulative outcome at 18 months 88% and 98%, respectively), discussions of prognosis were uncommon (baseline, 9.8%; by 18 months, 22.7%), as were conversations regarding ICD deactivation (baseline, 15.7%; by 18 months, 25.5%). Five decedents with available data received shocks in the days immediately prior to death, including 3 of whom ultimately had their ICDs deactivated prior to death. We demonstrated the feasibility of prospective enrollment and follow-up of older, vulnerable ICD patients. Early findings suggest a high burden of cognitive and psychological impairment, poor communication with providers, and frequent shocks at the end of life. These findings will inform the design of a larger cohort study designed to further explore the experiences of living and dying with an ICD in this important patient population. © 2017 The Authors. Published on behalf of the American Heart Association, Inc., by Wiley.

Using the Female Sexual Function Index (FSFI) to evaluate sexual function in women with genital mutilation undergoing surgical reconstruction: a pilot prospective study.

PubMed

Vital, Mathilde; de Visme, Sophie; Hanf, Matthieu; Philippe, Henri-Jean; Winer, Norbert; Wylomanski, Sophie

2016-07-01

Few prospective studies have evaluated sexual function in women with female genital mutilation by cutting (FGM/C) before and after clitoral reconstructive surgery, and none used a validated questionnaire. A validated questionnaire, the Female Sexual Function Index (FSFI) was used for the first time, to assess the impact of reconstructive surgery on sexual function in women with female genital mutilation/cutting (FGM/C) before and after clitoral reconstructive surgery. Women with FGM/C consulting at the Nantes University Hospital for clitoral reconstruction between 2013 and 2014 were prospectively included. All patients completed a questionnaire at inclusion, describing their social, demographic, and FGM/C characteristics. They were also asked to complete the FSFI as well as a questionnaire about clitoral sensations, symptoms of depression or anxiety, and self-esteem before and 3 and 6 months after the surgery. Paired Wilcoxon and McNemar tests were used to compare data. Of the 12 women included, 9 (75%) had type II mutilations. Results showed a global sexual dysfunction (median FSFI summary score=17) before surgery. Clitoral sensations were absent in 8 women (67%). Six months after surgery, all FSFI dimensions except lubrication had improved significantly (median FSFI summary score=29, P=0.009). Ten women had clitoral sensations, and 11 (92%) were satisfied with their surgery. This study shows that 6 months after clitoral reconstructive surgery, women reported a multidimensional positive improvement in their sexual function. The FSFI is a promising tool for routine standardized assessment of the sexual function of women with FGM/C for determining appropriate management and assessing it. Larger studies with validated questionnaires assessing self-esteem, depression, and body image are also needed to develop an integrative approach and to provide evidence-based recommendations about management of these women. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

Gender-Specific Combination HIV Prevention for Youth in High-Burden Settings: The MP3 Youth Observational Pilot Study Protocol.

PubMed

Buttolph, Jasmine; Inwani, Irene; Agot, Kawango; Cleland, Charles M; Cherutich, Peter; Kiarie, James N; Osoti, Alfred; Celum, Connie L; Baeten, Jared M; Nduati, Ruth; Kinuthia, John; Hallett, Timothy B; Alsallaq, Ramzi; Kurth, Ann E

2017-03-08

Nearly three decades into the epidemic, sub-Saharan Africa (SSA) remains the region most heavily affected by human immunodeficiency virus (HIV), with nearly 70% of the 34 million people living with HIV globally residing in the region. In SSA, female and male youth (15 to 24 years) are at a disproportionately high risk of HIV infection compared to adults. As such, there is a need to target HIV prevention strategies to youth and to tailor them to a gender-specific context. This protocol describes the process for the multi-staged approach in the design of the MP3 Youth pilot study, a gender-specific, combination, HIV prevention intervention for youth in Kenya. The objective of this multi-method protocol is to outline a rigorous and replicable methodology for a gender-specific combination HIV prevention pilot study for youth in high-burden settings, illustrating the triangulated methods undertaken to ensure that age, sex, and context are integral in the design of the intervention. The mixed-methods, cross-sectional, longitudinal cohort pilot study protocol was developed by first conducting a systematic review of the literature, which shaped focus group discussions around prevention package and delivery options, and that also informed age- and sex- stratified mathematical modeling. The review, qualitative data, and mathematical modeling created a triangulated evidence base of interventions to be included in the pilot study protocol. To design the pilot study protocol, we convened an expert panel to select HIV prevention interventions effective for youth in SSA, which will be offered in a mobile health setting. The goal of the pilot study implementation and evaluation is to apply lessons learned to more effective HIV prevention evidence and programming. The combination HIV prevention package in this protocol includes (1) offering HIV testing and counseling for all youth; (2) voluntary medical circumcision and condoms for males; (3) pre-exposure prophylaxis (PrEP), conditional cash transfer (CCT), and contraceptives for females; and (4) referrals for HIV care among those identified as HIV-positive. The combination package platform selected is mobile health teams in an integrated services delivery model. A cross-sectional analysis will be conducted to determine the uptake of the interventions. To determine long-term impact, the protocol outlines enrolling selected participants in mutually exclusive longitudinal cohorts (HIV-positive, PrEP, CCT, and HIV-negative) followed by using mobile phone text messages (short message service, SMS) and in-person surveys to prospectively assess prevention method uptake, adherence, and risk compensation behaviors. Cross-sectional and sub-cohort analyses will be conducted to determine intervention packages uptake. The literature review, focus groups, and modeling indicate that offering age- and gender- specific combination HIV prevention interventions that include biomedical, behavioral, and structural interventions can have an impact on HIV risk reduction. Implementing this protocol will show the feasibility of delivering these services at scale. The MP3 Youth study is one of the few combination HIV prevention intervention protocols incorporating youth- and gender-specific interventions in one delivery setting. Lessons learned from the design of the protocol can be incorporated into the national guidance for combination HIV prevention for youth in Kenya and other high-burden SSA settings. ClinicalTrials.gov NCT01571128; http://clinicaltrials.gov/ct2/show/NCT01571128?term=MP3+youth&rank=1 (Archived by WebCite at http://www.webcitation.org/6nmioPd54). ©Jasmine Buttolph, Irene Inwani, Kawango Agot, Charles M Cleland, Peter Cherutich, James N Kiarie, Alfred Osoti, Connie L Celum, Jared M Baeten, Ruth Nduati, John Kinuthia, Timothy B Hallett, Ramzi Alsallaq, Ann E Kurth. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 08.03.2017.

SUPERFUND TREATABILITY CLEARINGHOUSE: SOIL STABILIZATION PILOT STUDY, UNITED CHROME NPL SITE PILOT STUDY AND HEALTH AND SAFETY PROGRAM, UNITED CHROME NPL SITE PILOT STUDY

EPA Science Inventory

This document is a project plan for a pilot study at the United Chrome NPL site, Corvallis, Oregon and includes the health and safety and quality assurance/quality control plans. The plan reports results of a bench-scale study of the treatment process as iieasured by the ...

Abdominal compartment syndrome and ruptured aortic aneurysm: Validation of a predictive test (SCA-AAR).

PubMed

Leclerc, Betty; Salomon Du Mont, Lucie; Parmentier, Anne-Laure; Besch, Guillaume; Rinckenbach, Simon

2018-06-01

The abdominal compartment syndrome (ACS) has been clearly identified as being one of the main causes of mortality after ruptured abdominal aortic aneurysm (rAAA). The ACS is defined as a sustained intra-abdominal pressure > 20 mm Hg associated with a new organ dysfunction or failure. A pilot study was conducted and found that the threshold of 3 among 8 selected criteria, we would predict an ACS occurrence with a 54% positive predictive value and a 92% negative predictive value. But a multicentric prospective study was clearly needed to confirm these results. The outcome of this new study is to assess the qualities of a predictive test on occurrence of the ACS after rAAA surgery. This is a 30 months prospective cohort study conducted in 12 centers and 165 patients will be included. All patients with a rAAA will be consecutively included, whatever the surgical treatment. At the end of surgery, all patients have an abdominal closure and a monitoring of intrabladder pressure will be established every 3 to 4 hours. Decompressive laparotomy will be indicated when ACS occurs. Follow-up period is 1 month. Eight pre- and per-operative criteria will be studied: anemia, hypotension, cardiac arrest, obesity, massive fluid resuscitation, transfusion, hypothermia, and acidosis. In the literature, there is no recommendation about prophylactic decompression, but early decompressive laparotomy appears to improve survival. This study should make it possible to establish a predictive test, detect the ACS early, and consider a prophylactic decompression in the operating room. ClinicalTrials.gov, NCT02859662, Registered on 4 August 2016.

Training Opioid Addiction Treatment Providers to Adopt Contingency Management: A Prospective Pilot Trial of a Comprehensive Implementation Science Approach

PubMed Central

Becker, Sara J.; Squires, Daniel D.; Strong, David R.; Barnett, Nancy P.; Monti, Peter M.; Petry, Nancy M.

2016-01-01

Background Few prospective studies have evaluated theory-driven approaches to the implementation of evidence-based opioid treatment. This study compared the effectiveness of an implementation model (Science to Service Laboratory; SSL) to training as usual (TAU) in promoting the adoption of contingency management across a multi-site opiate addiction treatment program. We also examined whether the SSL affected putative mediators of contingency management adoption (perceived innovation characteristics and organizational readiness to change). Methods Sixty treatment providers (39 SSL, 21 TAU) from 15 geographically diverse satellite clinics (7 SSL, 8 TAU) participated in the 12-month study. Both conditions received didactic contingency management training and those in the pre-determined experimental region received 9 months of SSL-enhanced training. Contingency management adoption was monitored biweekly, while putative mediators were measured at baseline, 3-, and 12-months. Results Relative to providers in the TAU region, treatment providers in the SSL region had comparable likelihood of contingency management adoption in the first 20 weeks of the study, and then significantly higher likelihood of adoption (odds ratios = 2.4-13.5) for the remainder of the study. SSL providers also reported higher levels of one perceived innovation characteristic (Observability) and one aspect of organizational readiness to change (Adequacy of Training Resources), although there was no evidence that the SSL affected these putative mediators over time. Conclusions Results of this study indicate that a fully powered randomized trial of the SSL is warranted. Considerations for a future evaluation are discussed. PMID:26682582

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

PubMed

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

2014-03-26

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

A pilot study on the effect of a symbiotic mixture in irritable bowel syndrome: an open-label, partially controlled, 6-month extension of a previously published trial.

PubMed

Bucci, C; Tremolaterra, F; Gallotta, S; Fortunato, A; Cappello, C; Ciacci, C; Iovino, P

2014-04-01

In recent years, the efficacy of probiotics has received considerable attention in the treatment for irritable bowel syndrome (IBS). In this regard, a symbiotic mixture (Probinul(®)) has shown beneficial effects. The aim of this study was to extend the previously published 4-week randomized, double-blinded, placebo-controlled study of this symbiotic mixture. This is an open-label prospective, partially controlled, 6-month extension period pilot study in which patients continued to receive the symbiotic mixture (Group 1) or were switched from placebo to symbiotic mixture (Group 2) using cyclic administration (last 2 weeks/month). The primary endpoints were the overall satisfactory relief of bloating and flatulence (assessed as proportions of responders). The secondary endpoints were evaluation of the symptom severity scores (bloating, flatulence, pain and urgency) and bowel function scores (frequency, consistency and incomplete evacuation). Twenty-six IBS patients completed the 6-month extension period (13 patients in Group 1 and 13 patients in Group 2). In the per-protocol analysis, the proportions of responders across time were not significantly different in the groups but in Group 2, there was an increased percentage of responders for flatulence (p = 0.07). In addition, the score of flatulence was reduced significantly during the 6-month treatment period in Group 2 (p < 0.05), while no other significant differences were detected. Treatment with this symbiotic mixture was associated with persistence of relief from flatulence or new reduction in flatulence in the present 6-month long extension study. These results need to be more comprehensively assessed in large, long-term, randomized, placebo-controlled studies.

Can Probiotics Reduce Inflammation and Enhance Gut Immune Health in People Living with HIV: Study Designs for the Probiotic Visbiome for Inflammation and Translocation (PROOV IT) Pilot Trials.

PubMed

Kim, Connie J; Walmsley, Sharon L; Raboud, Janet M; Kovacs, Colin; Coburn, Bryan; Rousseau, Rodney; Reinhard, Robert; Rosenes, Ron; Kaul, Rupert

2016-07-01

Despite substantial improvements in HIV outcomes with combination antiretroviral therapy (cART), morbidity and mortality remain above population norms. The gut mucosal immune system is not completely restored by cART, and the resultant microbial translocation may contribute to chronic inflammation, inadequate CD4 T-cell recovery, and increased rates of serious non-AIDS events. Since the microbial environment surrounding a CD4 T cell may influence its development and function, we hypothesize that probiotics provided during cART might reduce inflammation and improve gut immune health in HIV-positive treatment-naïve individuals (PROOV IT I) and individuals with suboptimal CD4 recovery on cART (PROOV IT II). These prospective, double-blinded, randomized, placebo-controlled, multicenter pilot studies will assess the impact of the probiotic Visbiome at 900 billion bacteria daily. Forty HIV positive cART-naïve men will be randomized in the PROOV IT I study, coincident with antiretroviral initiation, and be followed for 24 weeks. In PROOV IT II, 36 men on cART, but with a CD4 T-cell count below 350 cells/mm(3) will be followed for 48 weeks. The primary outcome for both studies is the comparison of blood CD8 T-cell immune activation. Secondary analyses will include comparison of blood inflammatory biomarkers, microbial translocation, blood and gut immunology and HIV levels, the bacterial community composition, diet, intestinal permeability, and the safety, adherence and tolerability of the study product. These studies will evaluate the ability of probiotics as a safe and tolerable therapeutic intervention to reduce systemic immune activation and to accelerate gut immune restoration in people living with HIV.

Impact of the European clinical trials directive on prospective academic clinical trials associated with BMT.

PubMed

Frewer, L J; Coles, D; van der Lans, I A; Schroeder, D; Champion, K; Apperley, J F

2011-03-01

The European Clinical Trials Directive (EU 2001; 2001/20/EC) was introduced to improve the efficiency of commercial and academic clinical trials. Concerns have been raised by interested organizations and institutions regarding the potential for negative impact of the Directive on non-commercial European clinical research. Interested researchers within the European Group for Blood and Marrow Transplantation (EBMT) were surveyed to determine whether researcher experiences confirmed this view. Following a pilot study, an internet-based questionnaire was distributed to individuals in key research positions in the European haemopoietic SCT community. Seventy-one usable questionnaires were returned from participants in different EU member states. The results indicate that the perceived impact of the European Clinical Trials Directive has been negative, at least in the research areas of interest to the EBMT.

Operating results and reinjection of Milos field in Greece

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

Hibara, Y.; Tahara, M.; Sakanashi, H.

1989-01-01

The Milos geothermal prospect located on one of the Cycladean islands of Greece represents a high temperature (320{sup 0}C), high silica content (1150 ppm) modified sea water resource. The program of development under taken by the Public Power Corporation (PPC) of Greece started with the drilling of a number of wells and has progressed to the installation of a pilot-style 2MW(e) condensing power plant which went on-line in December 1986. This plant has been provided by Mitsubishi Heavy Industries (MHI) under a contract with PPC. Geothermal South Pacific (GEOSPAC) was sub-contracted to MHI to provide technical and scientific assistance inmore » connection with reservoir related matters. The authors present the various studies and modification that were done to establish an acceptable method of plant operation and waste disposal.« less

Deep Brain Stimulation in Early Parkinson’s Disease: Enrollment Experience from a Pilot Trial

PubMed Central

Charles, PD; Dolhun, RM; Gill, CE; Davis, TL; Bliton, MJ; Tramontana, MG; Salomon, RM; Wang; Hedera, P; Phibbs, FT; Neimat, JS; Konrad, PE

2011-01-01

Background Deep brain stimulation (DBS) of the subthalamic nucleus is an accepted therapy for advanced Parkinson’s disease (PD). In animal models, pharmacologic ablation and stimulation of the subthalamic nucleus have resulted in clinical improvement and, in some cases, improved survival of dopaminergic neurons. DBS has not been studied in the early stages of PD, but early application should be explored to evaluate safety, efficacy, and the potential to alter disease progression. Methods We are conducting a prospective, randomized, single-blind clinical trial of optimal drug therapy (ODT) compared to medication plus DBS (ODT + DBS) in subjects with Hoehn & Yahr Stage II idiopathic PD who are without motor fluctuations or dementia. We report here subject screening, enrollment, baseline characteristics, and adverse events. Results 30 subjects (average age 60 ± 6.9 years, average duration of medicine 2.1 ± 1.3 years, average UPDRS-III scores 14.9 on medication and 27.0 off medication) are enrolled in the ongoing study. Twelve of 15 subjects randomized to DBS experienced perioperative adverse events, the majority of which were related to the procedure or device and resolved without sequelae. Frequently reported adverse events included wound healing problems, headache, edema, and confusion. Conclusion This report demonstrates that subjects with early stage PD can be successfully recruited, consented and retained in a long term clinical trial of DBS. Our ongoing pilot investigation will provide important preliminary safety and tolerability data concerning the application of DBS in early stage PD. PMID:22104012

An open-label pilot study of granulocyte colony-stimulating factor for the treatment of severe endoscopic postoperative recurrence in Crohn's disease.

PubMed

Dejaco, Clemens; Lichtenberger, Conny; Miehsler, Wolfgang; Oberhuber, Georg; Herbst, Friedrich; Vogelsang, Harald; Gangl, Alfred; Reinisch, Walter

2003-01-01

Recombinant human granulocyte colony-stimulating factor (rhG-CSF) promoted healing of Crohn's disease (CD)-like intestinal lesions in chronic granulomatous disease and glycogen storage disease Ib, both characterized by defective neutrophil functions. We performed a prospective, open-label pilot study with rhG-CSF for the treatment of CD. Five patients with clinically inactive CD, but with severe endoscopic ileitis within 1 year after intestinal resection and ileocolonic anastomosis, received 300 microg of rhG-CSF (Filgrastim; Neupogen) subcutaneously, three times weekly for a total of 12 weeks. Safety was evaluated by assessment of clinical and laboratory data and disease activity. The primary parameter of efficacy was complete mucosal healing, as defined by the Rutgeerts score. Anti-inflammatory mediators were repeatedly measured during treatment. All patients completed the protocol in clinical remission. In 1 subject transient headache resolved after halving the rhG-CSF dosage. Complete mucosal healing was observed in 2 patients: in 1 patient after 12 weeks of therapy and in 1 patient 9 months after treatment cessation. In a single patient, closure of an anovaginal and of a perianal fistula was noted. Neutrophil counts and interleukin-1 receptor antagonist and soluble tumor necrosis factor receptor p55 and p75 levels were found to be increased during drug administration. rhG-CSF seems to be safe, well tolerated, and might provide efficacy in CD. Copyright 2003 S. Karger AG, Basel

Novel antireflux covered metal stent for recurrent occlusion of biliary metal stents: a pilot study.

PubMed

Hamada, Tsuyoshi; Isayama, Hiroyuki; Nakai, Yousuke; Kogure, Hirofumi; Togawa, Osamu; Kawakubo, Kazumichi; Yamamoto, Natsuyo; Ito, Yukiko; Sasaki, Takashi; Tsujino, Takeshi; Sasahira, Naoki; Hirano, Kenji; Tada, Minoru; Koike, Kazuhiko

2014-03-01

Feasibility of antireflux metal stent (ARMS), designed to prevent duodenobiliary reflux, was reported in patients with distal malignant biliary obstruction. In this prospective pilot study, we aimed to evaluate a newly designed ARMS as a reintervention for self-expandable metallic stent (SEMS) occlusion believed to be caused by duodenobiliary reflux. Patients with non-resectable distal malignant biliary obstruction were included in whom a prior SEMS was occluded as a result of sludge or food impaction between March 2010 and January 2012 at two Japanese tertiary referral centers. The occluded SEMS were endoscopically removed, if possible, and subsequently replaced by a newly designed ARMS. We evaluated the technical success rate and complications of ARMS and compared the time to occlusion of ARMS with that of prior SEMS. A total of 13 patients were included. ARMS was successfully placed in all patients in a single procedure. No procedure-related complications were identified. ARMS occlusion occurred in two patients (15%), the causes of which were sludge in one patient and unknown in the other. ARMS migration occurred in four patients (31%). ARMS patency time was significantly longer than that of prior SEMS (median, not available vs 58 days; P = 0.039). This newly designed ARMS is a technically feasible, safe, and effective reintervention for SEMS occlusion as a result of sludge or food impaction. An anti-migration mechanism to improve the outcomes of ARMS should be considered. © 2013 The Authors. Digestive Endoscopy © 2013 Japan Gastroenterological Endoscopy Society.

Pilot study of a novel, large-bore, fully covered self-expandable metallic stent for unresectable distal biliary malignancies.

PubMed

Mukai, Tsuyoshi; Yasuda, Ichiro; Isayama, Hiroyuki; Iwashita, Takuji; Itoi, Takao; Kawakami, Hiroshi; Kogure, Hirofumi; Nakai, Yousuke

2016-09-01

In patients with unresectable malignant distal biliary obstruction, covered self-expandable metallic stents (CSEMS) may remain patent longer than uncovered self-expandable metallic stents as a result of tumor ingrowth prevention. One main cause of recurrent biliary obstruction (RBO) in CSEMS is sludge formation, which can be prevented using a large-bore stent. Therefore, we developed a novel, 12-mm diameter fully covered SEMS (FCSEMS) and investigated its clinical safety, efficacy, and rate of adverse events. This prospective, multicenter pilot study, which ran between June 2011 and November 2012, included 38 consecutive patients with unresectable malignant distal biliary obstruction. All patients underwent endoscopic insertion of our novel stent. Primary endpoint was non-RBO rate 6 months after placement. Technical and functional success rates of the procedures were 100%. Six-month non-RBO rate was 50%, and median time to RBO was 184 days. Median survival time was 241 days. Twelve patients died within 6 months after stent placement without RBO. RBO was observed in 10 patients (26%), with seven experiencing stent occlusion and three experiencing stent migration. Adverse events other than RBO (at <30 days) developed in six patients (16%; cholecystitis, one; pancreatitis, one; hyperamylasemia, one; pancreatic ductitis, one; abdominal pain, two). Stent removal for reintervention was successfully completed in eight patients. Our novel FCSEMS may be safe and effective for managing malignant distal obstruction with an acceptable incidence of adverse events. © 2016 Japan Gastroenterological Endoscopy Society.

A pilot study using dynamic contrast enhanced-MRI as a response biomarker of the radioprotective effect of memantine in patients receiving whole brain radiotherapy

PubMed Central

Wong, Philip; Leppert, Ilana R.; Roberge, David; Boudam, Karim; Brown, Paul D.; Muanza, Thierry; Pike, G. Bruce; Chankowsky, Jeffrey; Mihalcioiu, Catalin

2016-01-01

Purpose This pilot prospective study sought to determine whether dynamic contrast enhanced MRI (DCE-MRI) could be used as a clinical imaging biomarker of tissue toxicity from whole brain radiotherapy (WBRT). Method 14 patients who received WBRT were imaged using dynamic contrast enhanced DCE-MRI prior to and at 8-weeks, 16-weeks and 24-weeks after the initiation of WBRT. Twelve of the patients were also enrolled in the RTOG 0614 trial, which randomized patients to the use of placebo or memantine. After the unblinding of the treatments received by RTOG 0614 patients, DCE-MRI measures of tumor tissue and normal appearing white matter (NAWM) vascular permeability (Initial Area Under the Curve (AUC) Blood Adjusted) was analyzed. Cognitive, quality-of-life (QOL) assessment and blood samples were collected according to the patient's ability to tolerate the exams. Circulating endothelial cells (CEC) were measured using flow cytometry. Results Following WBRT, there was an increasing trend in the vascular permeability of tumors (p=0.09) and NAWM (p=0.06) with time. Memantine significantly (p=0.01) reduced NAWM AUC changes following radiotherapy. Patients on memantine retained (COWA p= 0.03) better cognitive functions than those on placebo. No association was observed between the level of CEC and DCE-MRI changes, time from radiotherapy or memantine use. Conclusions DCE-MRI can detect vascular damage secondary to WBRT. Our data suggests that memantine reduces WBRT-induced brain vasculature damages. PMID:27248467

Serum lipid profile changes after successful treatment with electroconvulsive therapy in major depression: A prospective pilot trial.

PubMed

Aksay, Suna Su; Bumb, Jan Malte; Janke, Christoph; Biemann, Ronald; Borucki, Katrin; Lederbogen, Florian; Deuschle, Michael; Sartorius, Alexander; Kranaster, Laura

2016-01-01

Cholesterol is reduced in depressed patients, however, these patients have a higher risk for cardiovascular diseases. Electroconvulsive therapy (ECT) is a highly effective treatment option for specific forms of depression. Like for other non-pharmacological therapies targeting depression such as psychotherapy or sleep deprivation, there is a lack of evidence about the effects on peripheral lipid parameters. Our objective was to study the impact of ECT as a non-pharmacological treatment on the peripheral lipid pattern in depressive patients. Peripheral lipid profile composition before and after a course of ECT was analysed in 27 non-fasting inpatients at a university psychiatric hospital with DSM-IV major depressive episode. For the impact of ECT treatment on each lipid parameter a multivariate repeated measurement regression analysis was performed and computed separately for every dependent variable. Total Cholesterol and the cholesterol subtypes HDL and LDL were increased after the treatment compared to baseline. Apolipoprotein A1 was also increased after ECT, whereas apolipoprotein B was not. Indices for the prediction of cardiovascular diseases were unchanged after successful treatment by ECT. The reduction of depressive psychopathology negatively correlated with increases of HDL cholesterol and apolipoprotein A1. Subjects received several antidepressants and other psychotropic medication before and during the ECT. In our preliminary pilot study ECT as a non-pharmacological, effective treatment of depression led to distinct effects on the peripheral lipid pattern. Copyright © 2015 Elsevier B.V. All rights reserved.

The Effect of Depo Medroxyprogesterone Acetate (DMPA) on Cerebral Food Motivation Centers: A Pilot Study using Functional Magnetic Resonance Imaging.

PubMed

Basu, Tania; Bao, Pinglei; Lerner, Alexander; Anderson, Lindsey; Page, Kathleen; Stanczyk, Frank; Mishell, Daniel; Segall-Gutierrez, Penina

2016-10-01

The primary objective is to examine activation of food motivation centers in the brain before and 8 weeks after depo medroxyprogesterone acetate (DMPA) administration. This prospective experimental pilot study examined the effects of DMPA on food motivation centers utilizing functional magnetic resonance imaging (fMRI) in eight nonobese, ovulatory subjects. fMRI blood oxygen level dependent (BOLD) signal was measured using a 3-Tesla Scanner while participants viewed images of high-calorie foods, low-calorie foods and nonfood objects. fMRI scans were performed at baseline and 8 weeks after participants received one intramuscular dose of DMPA 150 mg. fMRI data were analyzed using the FMRIB Software Library. Changes in adiposity and circulating leptin and ghrelin levels were also measured. There was a greater BOLD signal response to food cues in brain regions associated with food motivation (anterior cingulate gyrus, orbitofrontal cortex) 8 weeks after DMPA administration compared to baseline (z>2.3, p<.05 whole-brain analysis clustered corrected). No statistically significant change was detected in circulating leptin or ghrelin levels or fat mass 8 weeks after DMPA administration. Analysis of differences in food motivation may guide the development of interventions to prevent weight gain in DMPA users. These data support a neural origin as one of the mechanisms underlying weight gain in DMPA users and may guide future research examining weight gain and contraception. Copyright © 2016 Elsevier Inc. All rights reserved.

Do telemonitoring projects of heart failure fit the Chronic Care Model?

PubMed Central

Willemse, Evi; Adriaenssens, Jef; Dilles, Tinne; Remmen, Roy

2014-01-01

This study describes the characteristics of extramural and transmural telemonitoring projects on chronic heart failure in Belgium. It describes to what extent these telemonitoring projects coincide with the Chronic Care Model of Wagner. Background The Chronic Care Model describes essential components for high-quality health care. Telemonitoring can be used to optimise home care for chronic heart failure. It provides a potential prospective to change the current care organisation. Methods This qualitative study describes seven non-invasive home-care telemonitoring projects in patients with heart failure in Belgium. A qualitative design, including interviews and literature review, was used to describe the correspondence of these home-care telemonitoring projects with the dimensions of the Chronic Care Model. Results The projects were situated in primary and secondary health care. Their primary goal was to reduce the number of readmissions for chronic heart failure. None of these projects succeeded in a final implementation of telemonitoring in home care after the pilot phase. Not all the projects were initiated to accomplish all of the dimensions of the Chronic Care Model. A central role for the patient was sparse. Conclusion Limited financial resources hampered continuation after the pilot phase. Cooperation and coordination in telemonitoring appears to be major barriers but are, within primary care as well as between the lines of care, important links in follow-up. This discrepancy can be prohibitive for deployment of good chronic care. Chronic Care Model is recommended as basis for future. PMID:25114664

Do telemonitoring projects of heart failure fit the Chronic Care Model?

PubMed

Willemse, Evi; Adriaenssens, Jef; Dilles, Tinne; Remmen, Roy

2014-07-01

This study describes the characteristics of extramural and transmural telemonitoring projects on chronic heart failure in Belgium. It describes to what extent these telemonitoring projects coincide with the Chronic Care Model of Wagner. The Chronic Care Model describes essential components for high-quality health care. Telemonitoring can be used to optimise home care for chronic heart failure. It provides a potential prospective to change the current care organisation. This qualitative study describes seven non-invasive home-care telemonitoring projects in patients with heart failure in Belgium. A qualitative design, including interviews and literature review, was used to describe the correspondence of these home-care telemonitoring projects with the dimensions of the Chronic Care Model. The projects were situated in primary and secondary health care. Their primary goal was to reduce the number of readmissions for chronic heart failure. None of these projects succeeded in a final implementation of telemonitoring in home care after the pilot phase. Not all the projects were initiated to accomplish all of the dimensions of the Chronic Care Model. A central role for the patient was sparse. Limited financial resources hampered continuation after the pilot phase. Cooperation and coordination in telemonitoring appears to be major barriers but are, within primary care as well as between the lines of care, important links in follow-up. This discrepancy can be prohibitive for deployment of good chronic care. Chronic Care Model is recommended as basis for future.

Throwing enhances humeral shaft cortical bone properties in pre-pubertal baseball players: a 12-month longitudinal pilot study.

PubMed

Weatherholt, Alyssa M; Warden, Stuart J

2018-06-01

To explore throwing athletes as a prospective, within-subject controlled model for studying the response of the skeleton to exercise. Male pre-pubertal throwing athletes (n=12; age=10.3±0.6 yrs) had distal humerus cortical volumetric bone mineral density (Ct.vBMD), cortical bone mineral content (Ct.BMC), total area (Tt.Ar), cortical area (Ct.Ar), medullary area (Me.Ar), cortical thickness (Ct.Th) and polar moment of inertia (IP) assessed within their throwing (exercised) and nonthrowing (control) arms by peripheral quantitative computed tomography at baseline and 12 months. Throwing-to-nonthrowing arm percent differences (i.e. bilateral asymmetry) were compared over time. Over 12 months, the throwing arm gained 4.3% (95% Cl=1.1% to 7.5%), 2.9% (95% Cl=0.3% to 5.4%), 3.9% (95% Cl=0.7% to 7.0%), and 8.2% (95% Cl=2.0% to 6.8%) more Ct.BMC, Ct.Ar, Tt.Ar, and I P than the nonthrowing arm, respectively (all p<0.05). There was no significant effect of throwing on Ct.vBMD, Ct.Th and Me.Ar (all p=0.18-0.82). Throwing induced surface-specific cortical bone adaptation at the distal humeral diaphysis that contributed to a gain in estimated strength. These longitudinal pilot data support the utility of throwing athletes as a within-subject controlled model to explore factors influencing exercise-induced bone adaptation during the critical growing years.