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.

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

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.

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

PubMed

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

2018-01-05

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

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

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.

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.

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 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.

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.

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.

[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

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.

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.

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.

[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.

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.

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

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

Cognitive Symptom Management and Rehabilitation Therapy (CogSMART) for veterans with traumatic brain injury: pilot randomized controlled trial.

PubMed

Twamley, Elizabeth W; Jak, Amy J; Delis, Dean C; Bondi, Mark W; Lohr, James B

2014-01-01

Traumatic brain injury (TBI) can result in cognitive impairments and persistent postconcussive symptoms that limit functional recovery, including return to work. We evaluated a 12 wk compensatory cognitive training intervention (Cognitive Symptom Management and Rehabilitation Therapy [CogSMART]) in the context of supported employment for Veterans with mild to moderate TBI. Participants were randomly assigned to receive 12 wk of supported employment plus CogSMART or enhanced supported employment that controlled for therapist attention (control). CogSMART sessions were delivered by the employment specialist and included psychoeducation regarding TBI; strategies to improve sleep, fatigue, headaches, and tension; and compensatory cognitive strategies in the domains of prospective memory, attention, learning and memory, and executive functioning. Compared with controls, those assigned to supported employment plus CogSMART demonstrated significant reductions in postconcussive symptoms (Cohen d = 0.97) and improvements in prospective memory functioning (Cohen d = 0.72). Effect sizes favoring CogSMART for posttraumatic stress disorder symptom severity, depressive symptom severity, and attainment of competitive work within 14 wk were in the small to medium range (Cohen d = 0.35-0.49). Those who received CogSMART rated the intervention highly. Results suggest that adding CogSMART to supported employment may improve postconcussive symptoms and prospective memory. These effects, as well as smaller effects on psychiatric symptoms and ability to return to work, warrant replication in a larger trial.

Prospective randomized comparison of dacarbazine (DTIC) versus DTIC plus interferon-alpha (IFN-alpha) in metastatic melanoma.

PubMed

Young, A M; Marsden, J; Goodman, A; Burton, A; Dunn, J A

2001-01-01

Dacarbazine (DTIC) has been the mainstay of chemotherapy for metastatic melanoma for over two decades, but only 15%-20% of patients respond and benefit is usually transient. Randomized studies combining DTIC with interferon-alpha (IFN-alpha) in advanced disease have so far been inconclusive in terms of response and survival. We report a randomized prospective pilot Phase III trial of DTIC +IFN-alpha in patients with metastatic melanoma. The primary endpoint was death. A total of 61 patients were randomized between April 1995 and April 1998. Differences in survival between groups were assessed using log-rank analysis. Quality of life was measured using the European Organization for Research on Treatment of Cancer QLQ C30 (+3) questionnaire. Fifty-seven patients died during the study. The median survival for patients receiving DTIC was 7.2 months (95% confidence interval (CI) 4.4-9.0); it was 4.8 months for DTIC + IFN-alpha (95% CI 2.0-8.0). There was no significant difference in survival between the two treatment arms (chi2 unadjusted = 0.15, P = 0.70; chi2 adjusted = 0.01, P = 0.91). The 6-month survival of those patients randomized to DTIC alone was 58% compared with 40% for those patients randomized to DTIC + IFN-alpha. There were no differences in quality of life between treatment groups. This study failed to demonstrate a survival benefit for patients receiving IFN-alpha in combination with DTIC. These results are inconclusive primarily owing to the small size of the trial. A meta-analysis is required to determine whether there is a role for the addition of IFN-alpha to DTIC in the treatment of this disease.

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

Trial of early noninvasive ventilation for ALS: A pilot placebo-controlled study.

PubMed

Jacobs, Teresa L; Brown, Devin L; Baek, Jonggyu; Migda, Erin M; Funckes, Timothy; Gruis, Kirsten L

2016-11-01

To evaluate the use and tolerability of noninvasive positive pressure ventilation (NIV) in patients with amyotrophic lateral sclerosis (ALS) early in their disease by comparing active NIV and sham NIV in patients not yet eligible for NIV use as recommended by practice guidelines. This was a single-center, prospective, double-blind, randomized, placebo (sham)-controlled pilot trial. Patients with ALS were randomized to receive either sham NIV or active NIV and underwent active surveillance approximately every 3 months until they reached a forced vital capacity (FVC) <50% or required NIV for clinical symptom management. In total, 54 participants were randomized. The mean NIV use was 2.0 hours (95% confidence interval [CI] 1.1-3.0) per day in the sham NIV treatment group and 3.3 hours (CI 2.0-4.6) per day in the active NIV group, which did not differ by treatment group (p = 0.347). The majority of sham NIV participants (88%) and active NIV participants (73%) reported only mild or no problem with NIV use. Difference of change in FVC through the treatment period by group (0.44 per month) favored active NIV (p = 0.049). Survival and changes in maximal inspiratory or expiratory pressure did not differ between treatment groups. The efficacy of early NIV in ALS should be tested in randomized, placebo-controlled trials. The trial is registered on clinicaltrials.gov (NCT00580593). This study provides Class II evidence that for patients with ALS, adherence with NIV and sham NIV are similar. © 2016 American Academy of Neurology.

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.

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.

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.

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.

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.

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.

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.

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.

75 FR 8190 - Proposed Collection; Comment Request

Federal Register 2010, 2011, 2012, 2013, 2014

2010-02-23

... soliciting comments concerning the Financial Education and Counseling (FEC) Pilot Program Application. DATES... Education and Counseling Pilot Program Application. OMB Number: 1559-0034. Abstract: The purpose of the FEC... financial education and counseling services to prospective homebuyers. The FEC Pilot Program was authorized...

Pilot non dialysis chronic renal insufficiency study (P-ND-CRIS): a pilot study of an open prospective hospital-based French cohort.

PubMed

Massol, Jacques; Janin, Gérard; Bachot, Camille; Gousset, Christophe; Deville, Geoffroy Sainte-Claire; Chalopin, Jean-Marc

2017-02-01

Before establishing a prospective cohort, an initial pilot study is recommended. However, there are no precise guidelines on this subject. This paper reports the findings of a French regional pilot study carried out in three nephrology departments, before realizing a major prospective Non Dialysis Chronic Renal Insufficiency study (ND-CRIS). We carried out an internal pilot study. The objectives of this pilot study were to validate the feasibility (regulatory approval, providing patients with information, availability of variables, refusal rate of eligible patients) and quality criteria (missing data, rate of patients lost to follow-up, characteristics of the patients included and non-included eligible patients, quality control of the data gathered) and estimate the human resources necessary (number of clinical research associates required). The authorizations obtained (CCTIRS - CNIL) and the contracts signed with hospitals have fulfilled the regulatory requirements. After validating the information on the study provided to patients, 1849 of them were included in three centres (university hospital, intercommunal hospital, town hospital) between April 2012 and September 2015. The low refusal rate (51 patients) and the characteristics of non-included patients have confirmed the benefit for patients of participating in the study and provide evidence of the feasibility and representativeness of the population studied. The lack of missing data on the variables studied, the quality of the data analyzed and the low number of patients lost to follow-up are evidence of the quality of the study. By taking into account the time spent by CRAs to enter data and to travel, as well as the annual patient numbers in each hospital, we estimate that five CRAs will be required in total. With no specific guidelines on how to realize a pilot study before implementing a major prospective cohort, we considered it pertinent to report our experience of P-ND-CRIS. This experience confirms that i) feasibility, ii) quality of data and iii) evaluating the resources required must be validated before carrying out a large prospective cohort study such as ND-CRIS.

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

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

An open, prospective, randomized pilot investigation evaluating pain with the use of a soft silicone wound contact layer vs bridal veil and staples on split thickness skin grafts as a primary dressing.

PubMed

Patton, Mary Lou; Mullins, Robert Fred; Smith, David; Korentager, Richard

2013-01-01

An open, prospective, randomized, pilot investigation was implemented to evaluate the pain, cost-effectiveness, ease of use, tolerance, efficacy, and safety of a soft silicone wound contact layer (Mepitel One) vs Bridal Veil and staples used on split thickness skin grafts in the treatment of deep partial or full-thickness thermal burns. Individuals aged between 18 and 70 years with deep partial or full-thickness thermal burns (1-25% TBSA) were randomized into two groups and treated for 14 days or until greater than 95% graft take was achieved, whichever occurred first. Data were obtained and analyzed on pain experienced before, during, and after dressing removal. Secondary considerations included the overall cost (direct), graft take and healing, the ease of product use, overall experience of the dressing, and adverse events. A total of 43 subjects were recruited. There were no significant differences in burn area profiles within the groups. The pain level during dressing removal was significant between the groups (P = .0118) with the removal of Mepitel One being less painful. The staff costs were lower in the group of patients treated with Mepitel One (P = .0064) as reflected in the shorter time required for dressing removal (P = .0005), with Mepitel One taking on average less than a quarter of the time to remove. There was no significant difference in healing between the two groups, with 99.0% of the Mepitel One group and 93.1% of the Bridal Veil and staples group showing greater than 95% graft take at post-op day 7 (+/-1) (P = .2373). Clinicians reported that the soft silicone dressing was easier to use, more conformable, and demonstrated better ability to stay in place, compared with the Bridal Veil and staples regime. Both treatments were well tolerated, with no serious adverse events in either treatment group. Mepitel One was at least as effective in the treatment of patients as the standard care (Bridal Veil and staples). In addition, the group of patients treated with the soft silicone dressing demonstrated decreased pain and lower costs associated with treatment.

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.

Intravenous pantoprazole versus ranitidine for prevention of rebleeding after endoscopic hemostasis of bleeding peptic ulcers

PubMed Central

Hsu, Ping-I; Lo, Gin-Ho; Lo, Ching-Chu; Lin, Chiun-Ku; Chan, Hoi-Hung; Wu, Chung-Jen; Shie, Chang-Bih; Tsai, Pei-Min; Wu, Deng-Chyang; Wang, Wen-Ming; Lai, Kwok-Hung

2004-01-01

AIM: The role of intravenous pantoprazole in treatment of patients with high-risk bleeding peptic ulcers following endoscopic hemostasis remains uncertain. We therefore conducted the pilot prospective randomized study to assess whether intravenous pantoprazole could improve the efficacy of H2-antagonist as an adjunct treatment following endoscopic injection therapy for bleeding ulcers. METHODS: Patients with active bleeding ulcers or ulcers with major signs of recent bleeding were treated with distilled water injection. After hemostasis was achieved, they were randomly assigned to receive intravenous pantoprazole or ranitidine. RESULTS: One hundred and two patients were enrolled in this prospective trial. Bleeding recurred in 2 patients (4%) in the pantoprazole group (n = 52), as compared with 8 (16%) in the ranitidine group (n = 50). The rebleeding rate was significantly lower in the pantoprazole group (P = 0.04). There were no statistically significant differences between the groups with regard to the need for emergency surgery (0% vs 2%), transfusion requirements (4.9 ± 5.9 vs 5.7 ± 6.8 units), hospital days (5.9 ± 3.2 vs 7.5 ± 5.0 d) or mortality (2% vs 2%). CONCLUSION: Pantoprozole is superior to ranitidine as an adjunct treatment to endoscopic injection therapy in high-risk bleeding ulcers. PMID:15534928

Impact of sleep deprivation on anaesthesia residents' non-technical skills: a pilot simulation-based prospective randomized trial.

PubMed

Neuschwander, A; Job, A; Younes, A; Mignon, A; Delgoulet, C; Cabon, P; Mantz, J; Tesniere, A

2017-07-01

Sleep deprivation is common in anaesthesia residents, but its impact on performance remains uncertain. Non-technical skills (team working, situation awareness, decision making, and task management) are key components of quality of care in anaesthesia, particularly in crisis situations occurring in the operating room. The impact of sleep deprivation on non-technical skills is unknown. We tested the hypothesis that in anaesthesia residents sleep deprivation is associated with impaired non-technical skills. Twenty anaesthesia residents were randomly allocated to undergo a simulation session after a night shift [sleep-deprived (SLD) group, n =10] or after a night of rest [rested (R) group, n =10] from January to March 2015. The simulated scenario was a situation of crisis management in the operating room. The primary end point was a composite score of anaesthetists' non-technical skills (ANTS) assessed by two blinded evaluators. Non-technical skills were significantly impaired in the SLD group [ANTS score 12.2 (interquartile range 10.5-13)] compared with the R group [14.5 (14-15), P <0.02]. This difference was mainly accounted for by a difference in the team working item. On the day of simulation, the SLD group showed increased sleepiness and decreased confidence in anaesthesia skills. In this randomized pilot trial, sleep deprivation was associated with impaired non-technical skills of anaesthesia residents in a simulated anaesthesia intraoperative crisis scenario. NCT02622217. © The Author 2017. Published by Oxford University Press on behalf of the British Journal of Anaesthesia. All rights reserved. For Permissions, please email: journals.permissions@oup.com

Training cognitive flexibility in patients with anorexia nervosa: a pilot randomized controlled trial of cognitive remediation therapy.

PubMed

Brockmeyer, Timo; Ingenerf, Katrin; Walther, Stephan; Wild, Beate; Hartmann, Mechthild; Herzog, Wolfgang; Bents, Hinrich; Friederich, Hans-Christoph

2014-01-01

Inefficient cognitive flexibility is considered a neurocognitive trait marker involved in the development and maintenance of anorexia nervosa (AN). Cognitive Remediation Therapy (CRT) is a specific treatment targeting this cognitive style. The aim of this study was to investigate the feasibility and efficacy (by estimating the effect size) of specifically tailored CRT for AN, compared to non-specific cognitive training. A prospective, randomized controlled, superiority pilot trial was conducted. Forty women with AN receiving treatment as usual (TAU) were randomized to receive either CRT or non-specific neurocognitive therapy (NNT) as an add-on. Both conditions comprised 30 sessions of computer-assisted (21 sessions) and face-to-face (9 sessions) training over a 3-week period. CRT focused specifically on cognitive flexibility. NNT was comprised of tasks designed to improve attention and memory. The primary outcome was performance on a neuropsychological post-treatment assessment of cognitive set-shifting. Data available from 25 treatment completers were analyzed. Participants in the CRT condition outperformed participants in the NNT condition in cognitive set-shifting at the end of the treatment (p = 0.027; between-groups effect size d = 0.62). Participants in both conditions showed high treatment acceptance. This study confirms the feasibility of CRT for AN, and provides a first estimate of the effect size that can be achieved using CRT for AN. Furthermore, the present findings corroborate that neurocognitive training for AN should be tailored to the specific cognitive inefficiencies of this patient group. Copyright © 2013 Wiley Periodicals, Inc.

Effects of Minocycline on Urine Albumin, Interleukin-6, and Osteoprotegerin in Patients with Diabetic Nephropathy: A Randomized Controlled Pilot Trial

PubMed Central

Wang, Ying; Tong, Lili; Pak, Youngju; Andalibi, Ali; LaPage, Janine A.; Adler, Sharon G.

2016-01-01

Background We tested minocycline as an anti-proteinuric adjunct to renin-angiotensin-aldosterone system inhibitors (RAASi) in diabetic nephropathy (DN) and measured urinary biomarkers to evaluate minocycline’s biological effects. Methods Design: Prospective, single center, randomized, placebo-controlled, intention-to-treat pilot trial. Inclusion. Type 2 diabetes/DN; Baseline creatinine clearance > 30 mL/min; proteinuria ≥ 1.0 g/day; Age ≥30 years; BP <150/95 mm Hg; intolerant of/at maximum RAASi dose. Protocol. 3-wk screening; Baseline randomization; Urine and blood measures at months 1, 2, 4, and Month 6 study completion. Urine interleukin-6 (IL-6) and osteoprotegerin were measured in a subset. Primary outcome. Natural log of urine protein/creatinine (ln U P:Cr) ratio at Month 6 vs Baseline. Results 30 patients completed the study. The 15% decline in U P: Cr in minocycline patients (6 month P:Cr ÷ Baseline P:Cr, 0.85 vs. 0.92) was not significant (p = 0.27). Creatinine clearance did not differ in the 2 groups. Urine IL-6:Cr (p = 0.03) and osteoprotegerin/Cr (p = 0.046) decrements were significant. Minocycline modified the relationship between urine IL-6 and proteinuria, suggesting a protective biological effect. Conclusions Although the decline in U P:Cr in minocycline patients was not statistically significant, the significant differences in urine IL-6 and osteoprotegerin suggest that minocycline may confer cytoprotection in patients with DN, providing a rationale for further study. Trial Registration Clinicaltrials.gov NCT01779089 PMID:27019421

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.

The Walking School Bus and children's physical activity: A pilot cluster randomized controlled trial

USDA-ARS?s Scientific Manuscript database

To evaluate the impact of a "walking school bus" program on children's rates of active commuting to school and physical activity. We conducted a pilot cluster randomized controlled trial among 4th-graders from 8 schools in Houston, Texas (N = 149). Random allocation to treatment or control condition...

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).

Milrinone therapy for enterovirus 71-induced pulmonary edema and/or neurogenic shock in children: a randomized controlled trial.

PubMed

Chi, Chia-Yu; Khanh, Truong Huu; Thoa, Le Phan Kim; Tseng, Fan-Chen; Wang, Shih-Min; Thinh, Le Quoc; Lin, Chia-Chun; Wu, Han-Chieh; Wang, Jen-Ren; Hung, Nguyen Thanh; Thuong, Tang Chi; Chang, Chung-Ming; Su, Ih-Jen; Liu, Ching-Chuan

2013-07-01

Enterovirus 71-induced brainstem encephalitis with pulmonary edema and/or neurogenic shock (stage 3B) is associated with rapid mortality in children. In a small pilot study, we found that milrinone reduced early mortality compared with historical controls. This prospective, randomized control trial was designed to provide more definitive evidence of the ability of milrinone to reduce the 1-week mortality of stage 3B enterovirus 71 infections. Prospective, unicenter, open-label, randomized, controlled study. Inpatient ward of a large tertiary teaching hospital in Ho Chi Minh City, Vietnam. Children (≤ 18 yr old) admitted with proven enterovirus 71-induced pulmonary edema and/or neurogenic shock. Patients were randomly assigned to receive intravenous milrinone (0.5 μg/kg/min) (n = 22) or conventional management (n = 19). Both groups received dopamine or dobutamine and intravenous immunoglobulin. The primary endpoint was 1-week mortality. The secondary endpoints included length of ventilator dependence and hospital stay and adverse events. The median age was 2 years with a predominance of boys in both groups. The 1-week mortality was significantly lower, 18.2% (4/22) in the milrinone compared with 57.9% (11/19) in the conventional management group (relative risk = 0.314 [95% CI, 0.12-0.83], p = 0.01). The median duration of ventilator-free days was longer in the milrinone treatment group (p = 0.01). There was no apparent neurologic sequela in the survivors in either group, and no drug-related adverse events were documented. Milrinone significantly reduced the 1-week mortality of enterovirus 71-induced pulmonary edema and/or neurogenic shock without adverse effects. Further studies are needed to determine whether milrinone might be useful to prevent progression of earlier stages of brainstem encephalitis.

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

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.

Text messaging versus email for emergency medicine residents’ knowledge retention: a pilot comparison in the United States

PubMed Central

2016-01-01

We evaluated the effectiveness of text messaging versus email, as a delivery method to enhance knowledge retention of emergency medicine (EM) content in EM residents. We performed a multi-centered, prospective, randomized study consisting of postgraduate year (PGY) 1 to PGY 3 & 4 residents in three United States EM residency programs in 2014. Fifty eight residents were randomized into one delivery group: text message or email. Participants completed a 40 question pre- and post-intervention exam. Primary outcomes were the means of pre- and post-intervention exam score differences. Data were analyzed using descriptive statistics, paired t-test, and multiple linear regressions. No significant difference was found between the primary outcomes of the two groups (P=0.51). PGY 2 status had a significant negative effect (P=0.01) on predicted exam score difference. Neither delivery method enhanced resident knowledge retention. Further research on implementation of mobile technology in residency education is required. PMID:27780350

Text messaging versus email for emergency medicine residents' knowledge retention: a pilot comparison in the United States.

PubMed

Hoonpongsimanont, Wirachin; Kulkarni, Miriam; Tomas-Domingo, Pedro; Anderson, Craig; McCormack, Denise; Tu, Khoa; Chakravarthy, Bharath; Lotfipour, Shahram

2016-01-01

We evaluated the effectiveness of text messaging versus email, as a delivery method to enhance knowledge retention of emergency medicine (EM) content in EM residents. We performed a multi-centered, prospective, randomized study consisting of postgraduate year (PGY) 1 to PGY 3 & 4 residents in three United States EM residency programs in 2014. Fifty eight residents were randomized into one delivery group: text message or email. Participants completed a 40 question pre- and post-intervention exam. Primary outcomes were the means of pre- and post-intervention exam score differences. Data were analyzed using descriptive statistics, paired t-test, and multiple linear regressions. No significant difference was found between the primary outcomes of the two groups (P=0.51). PGY 2 status had a significant negative effect (P=0.01) on predicted exam score difference. Neither delivery method enhanced resident knowledge retention. Further research on implementation of mobile technology in residency education is required.

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

PubMed

Koley, Munmun; Saha, Subhranil; Ghosh, Shubhamoy

2015-07-01

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

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.

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

Impact on Seniors of the Patient-Centered Medical Home: Evidence from a Pilot Study

ERIC Educational Resources Information Center

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

2012-01-01

Purpose: 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. Design and Methods: A prospective before-and-after evaluation of the experience of seniors receiving primary care services at 1 pilot clinic…

Randomized Clinical Trial of Preoperative Feeding to Evaluate Intestinal Barrier Function in Neonates Requiring Cardiac Surgery.

PubMed

Zyblewski, Sinai C; Nietert, Paul J; Graham, Eric M; Taylor, Sarah N; Atz, Andrew M; Wagner, Carol L

2015-07-01

To evaluate intestinal barrier function in neonates undergoing cardiac surgery using lactulose/mannitol (L/M) ratio measurements, and to determine correlations with early breast milk feeding. This was a single-center, prospective, randomized pilot study of 27 term-born neonates (≥ 37 weeks gestation) requiring cardiac surgery who were randomized to 1 of 2 preoperative feeding groups: nil per os (NPO) or trophic (10 mL/kg/day) breast milk feeds. At 3 time points (preoperative [preop], postoperative [postop] day 7, and postop day 14), subjects were administered an oral L/M solution, after which urine L/M ratios were measured using gas chromatography, with higher ratios indicative of increased intestinal permeability. Trends over time in the mean urine L/M ratios for each group were estimated using a general linear mixed model. There were no adverse events related to preoperative trophic feeding. In the NPO group (n = 13), the mean urine L/M ratio was 0.06 at preop, 0.12 at postop day 7, and 0.17 at postop day 14. In the trophic breast milk feeds group (n = 14), the mean urine L/M ratio was 0.09 at preop, 0.19 at postop day 7, and 0.15 at postop day 14. In both groups, L/M ratios were significantly higher at postop day 7 and postop day 14 compared with preop (P < .05). Neonates have increased intestinal permeability after cardiac surgery extending to at least postop day 14. This pilot study was not powered to detect differences in benefit or adverse events comparing the NPO and trophic breast milk feeds groups. Further studies to identify mechanisms of intestinal injury and therapeutic interventions are warranted. Registered with ClinicalTrials.gov: NCT01475357. Copyright © 2015 Elsevier Inc. All rights reserved.

A Randomized Controlled Open-Label Pilot Study of Simvastatin Addition to Whole-Brain Radiation Therapy in Patients With Brain Metastases.

PubMed

El-Hamamsy, Manal; Elwakil, Hesham; Saad, Amr S; Shawki, May A

2016-10-27

Statins have been reported to have a potential radiosensitizing effect that has not been evaluated in clinical trials. The aim of this study was to evaluate the efficacy and safety of simvastatin in addition to whole-brain radiation therapy (WBRT) in patients with brain metastases (BM). A prospective randomized, controlled, open-label pilot study was conducted on 50 Egyptian patients with BM who were randomly assigned to receive 30-Gy WBRT (control group: 25 patients) or 30 Gy WBRT + simvastatin 80 mg/day for the WBRT period (simvastatin group: 25 patients). The primary outcome was radiological response at 4 weeks after WBRT. Secondary outcomes were 1-year progression-free survival (PFS), 1-year overall survival (OS), and health-related quality of life (HRQL) that was assessed using the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ-C30) and its brain module (BN-20), at baseline, after WBRT, and 4 weeks after WBRT. The addition of simvastatin was tolerated. Twenty-one patients were not evaluated for radiological response because of death (n = 16), noncompliance to follow-up (n = 4), and clinical deterioration (n = 1). Response rates were 60% and 78.6% (p = 0.427), 1-year PFS rates were 5.2% and 17.7% (p = 0.392), and 1-year OS rates were 12% and 8% (p = 0.880) for the control group and simvastatin group, respectively. Nonsignificant differences were found between the two arms regarding HRQL scales. The addition of simvastatin 80 mg/day did not improve the clinical outcomes of patients with BM receiving WBRT.

Weight-based enoxaparin dosing and deep vein thrombosis in hospitalized trauma patients: A double-blind, randomized, pilot study.

PubMed

Kay, Annika Bickford; Majercik, Sarah; Sorensen, Jeffrey; Woller, Scott C; Stevens, Scott M; White, Thomas W; Morris, David S; Baldwin, Margaret; Bledsoe, Joseph R

2018-04-23

Venous thromboembolism is a cause of morbidity and mortality in trauma patients. Chemoprophylaxis with low-molecular-weight heparin at a standardized dose is recommended. Conventional chemoprophylaxis may be inadequate. We hypothesized that a weight-adjusted enoxaparin prophylaxis regimen would reduce the frequency of venous thromboembolism in hospitalized trauma patients and at 90-day follow-up. This prospective, randomized pilot study enrolled adult patients admitted to a level 1 trauma center between July 2013 and January 2015. Subjects were randomized to receive either standard (30 mg subcutaneously every 12 hours) or weight-based (0.5mg/kg subcutaneously every 12 hours) enoxaparin. Surveillance duplex ultrasound for lower extremity deep vein thrombosis was performed on hospital days 1, 3, and 7, and weekly thereafter. The primary outcome was deep vein thrombosis during hospitalization. Secondary outcomes included venous thromboembolism at 90 days and significant bleeding events. Two hundred thirty-four (124 standard, 110 weight-based) subjects were enrolled. There was no difference between standard and weight-based regarding age, body mass index, percentage female gender, injury severity score, or percentage that had surgery. There was a trend toward less in-hospital deep vein thrombosis in weight-based (12 [9.7%] standard vs 4 [3.6%] weight-based, P = .075). At 90 days, there was no difference in venous thromboembolism (12 [9.7%] standard vs 6 [5.5%] weight-based, P =.34). There was 1 bleeding event, which occurred in a standard subject. Weight-based enoxaparin dosing for venous thromboembolism chemoprophylaxis in trauma patients may provide better protection against venous thromboembolism than standard. A definitive study is necessary to determine whether weight-based dosing is superior to standard. Copyright © 2018 Elsevier Inc. All rights reserved.

Cognitive-behavioural suicide prevention for male prisoners: a pilot randomized controlled trial.

PubMed

Pratt, D; Tarrier, N; Dunn, G; Awenat, Y; Shaw, J; Ulph, F; Gooding, P

2015-12-01

Prisoners have an exceptional risk of suicide. Cognitive-behavioural therapy for suicidal behaviour has been shown to offer considerable potential, but has yet to be formally evaluated within prisons. This study investigated the feasibility of delivering and evaluating a novel, manualized cognitive-behavioural suicide prevention (CBSP) therapy for suicidal male prisoners. A pilot randomized controlled trial of CBSP in addition to treatment as usual (CBSP; n = 31) compared with treatment as usual (TAU; n = 31) alone was conducted in a male prison in England. The primary outcome was self-injurious behaviour occurring within the past 6 months. Secondary outcomes were dimensions of suicidal ideation, psychiatric symptomatology, personality dysfunction and psychological determinants of suicide, including depression and hopelessness. The trial was prospectively registered (number ISRCTN59909209). Relative to TAU, participants receiving CBSP therapy achieved a significantly greater reduction in suicidal behaviours with a moderate treatment effect [Cohen's d = -0.72, 95% confidence interval -1.71 to 0.09; baseline mean TAU: 1.39 (S.D. = 3.28) v. CBSP: 1.06 (S.D. = 2.10), 6 months mean TAU: 1.48 (S.D. = 3.23) v. CBSP: 0.58 (S.D. = 1.52)]. Significant improvements were achieved on measures of psychiatric symptomatology and personality dysfunction. Improvements on psychological determinants of suicide were non-significant. More than half of the participants in the CBSP group achieved a clinically significant recovery by the end of therapy, compared with a quarter of the TAU group. The delivery and evaluation of CBSP therapy within a prison is feasible. CBSP therapy offers significant promise in the prevention of prison suicide and an adequately powered randomized controlled trial is warranted.

Postoperative pain after conventional laparoscopic versus single-port sleeve gastrectomy: a prospective, randomized, controlled pilot study.

PubMed

Morales-Conde, Salvador; Del Agua, Isaías Alarcón; Moreno, Antonio Barranco; Macías, María Socas

2017-04-01

Laparoscopic approach is the gold standard for surgical treatment of morbid obesity. The single-port (SP) approach has been demonstrated to be a safe and effective technique for the treatment of morbid obesity in several case control studies. Compare conventional multiport laparoscopy (LAP) with an SP approach for the treatment of morbid obesity using sleeve gastrectomy in terms of postoperative pain using a visual analog scale (VAS) 0-100, surgical outcome, weight loss, and aesthetical satisfaction at 6 months after surgery. University Hospital, Spain. Randomized, controlled pilot study. The trial enrolled patients suitable for bariatric surgery, with a body mass index lower than 50 kg/m 2 and xiphoumbilical distance lower than 25 cm. Patients were randomly assigned to receive LAP or SP sleeve gastrectomy. A total of 30 patients were enrolled; 15 were assigned to LAP group and 15 to SP group. No patients were lost during follow-up. Baseline characteristics were similar in both groups. A significantly higher level of pain during movement was noted for the patients in the LAP group on the first (mean VAS 49.3±12.2 versus 34.1±8.9, P = .046) and second days (mean VAS 35.9±10.2 versus 22.1±7.9, P = .044) but not the third day (mean VAS 20.1±5.2 versus 34.12.9 ±4.3, P = .620). No differences regarding pain at rest, operative time, complications, or weight loss at 6 months were observed. Higher aesthetical satisfaction was noticed in SP group. In selected patients, SP surgery presented less postoperative pain in sleeve gastrectomy compared with the conventional laparoscopic approach with similar surgical results. Copyright © 2017 American Society for Bariatric Surgery. Published by Elsevier Inc. All rights reserved.

Open Lung Approach for the Acute Respiratory Distress Syndrome: A Pilot, Randomized Controlled Trial.

PubMed

Kacmarek, Robert M; Villar, Jesús; Sulemanji, Demet; Montiel, Raquel; Ferrando, Carlos; Blanco, Jesús; Koh, Younsuck; Soler, Juan Alfonso; Martínez, Domingo; Hernández, Marianela; Tucci, Mauro; Borges, Joao Batista; Lubillo, Santiago; Santos, Arnoldo; Araujo, Juan B; Amato, Marcelo B P; Suárez-Sipmann, Fernando

2016-01-01

The open lung approach is a mechanical ventilation strategy involving lung recruitment and a decremental positive end-expiratory pressure trial. We compared the Acute Respiratory Distress Syndrome network protocol using low levels of positive end-expiratory pressure with open lung approach resulting in moderate to high levels of positive end-expiratory pressure for the management of established moderate/severe acute respiratory distress syndrome. A prospective, multicenter, pilot, randomized controlled trial. A network of 20 multidisciplinary ICUs. Patients meeting the American-European Consensus Conference definition for acute respiratory distress syndrome were considered for the study. At 12-36 hours after acute respiratory distress syndrome onset, patients were assessed under standardized ventilator settings (FIO2≥0.5, positive end-expiratory pressure ≥10 cm H2O). If Pao2/FIO2 ratio remained less than or equal to 200 mm Hg, patients were randomized to open lung approach or Acute Respiratory Distress Syndrome network protocol. All patients were ventilated with a tidal volume of 4 to 8 ml/kg predicted body weight. From 1,874 screened patients with acute respiratory distress syndrome, 200 were randomized: 99 to open lung approach and 101 to Acute Respiratory Distress Syndrome network protocol. Main outcome measures were 60-day and ICU mortalities, and ventilator-free days. Mortality at day-60 (29% open lung approach vs. 33% Acute Respiratory Distress Syndrome Network protocol, p = 0.18, log rank test), ICU mortality (25% open lung approach vs. 30% Acute Respiratory Distress Syndrome network protocol, p = 0.53 Fisher's exact test), and ventilator-free days (8 [0-20] open lung approach vs. 7 [0-20] d Acute Respiratory Distress Syndrome network protocol, p = 0.53 Wilcoxon rank test) were not significantly different. Airway driving pressure (plateau pressure - positive end-expiratory pressure) and PaO2/FIO2 improved significantly at 24, 48 and 72 hours in patients in open lung approach compared with patients in Acute Respiratory Distress Syndrome network protocol. Barotrauma rate was similar in both groups. In patients with established acute respiratory distress syndrome, open lung approach improved oxygenation and driving pressure, without detrimental effects on mortality, ventilator-free days, or barotrauma. This pilot study supports the need for a large, multicenter trial using recruitment maneuvers and a decremental positive end-expiratory pressure trial in persistent acute respiratory distress syndrome.

Prevention of hypothermia in patients undergoing orthotopic liver transplantation using the humigard® open surgery humidification system: a prospective randomized pilot and feasibility clinical trial.

PubMed

Weinberg, Laurence; Huang, Andrew; Alban, Daniel; Jones, Robert; Story, David; McNicol, Larry; Pearce, Brett

2017-01-23

Perioperative thermal disturbances during orthotopic liver transplantation (OLT) are common. We hypothesized that in patients undergoing OLT the use of a humidified high flow CO 2 warming system maintains higher intraoperative temperatures when compared to standardized multimodal strategies to maintain thermoregulatory homeostasis. We performed a randomized pilot study in adult patients undergoing primary OLT. Participants were randomized to receive either open wound humidification with a high flow CO 2 warming system in addition to standard care (Humidification group) or to standard care alone (Control group). The primary end point was nasopharyngeal core temperature measured 5 min immediately prior to reperfusion of the donor liver (Stage 3 - 5 min). Secondary endpoints included intraoperative PaCO 2 , minute ventilation and the use of vasoconstrictors. Eleven patients were randomized to each group. Both groups were similar for age, body mass index, MELD, SOFA and APACHE II scores, baseline temperature, and duration of surgery. Immediately prior to reperfusion (Stage 3 - 5 min) the mean (SD) core temperature was higher in the Humidification Group compared to the Control Group: 36.0 °C (0.13) vs. 35.4 °C (0.22), p = 0.028. Repeated measured ANOVA showed that core temperatures over time during the stages of the transplant were higher in the Humidification Group compared to the Control Group (p < 0.0001). There were no significant differences in the ETCO 2 , PaCO 2 , minute ventilation, or inotropic support. The humidified high flow CO 2 warming system was superior to standardized multimodal strategies in maintaining normothermia in patients undergoing OLT. Use of the device was feasible and did not interfere with any aspects of surgery. A larger study is needed to investigate if the improved thermoregulation observed is associated with improved patient outcomes. ACTRN12616001631493 . Retrospectively registered 25 November 2016.

A randomized study of remote monitoring and fluid monitoring for the management of patients with implanted cardiac arrhythmia devices.

PubMed

Lüthje, Lars; Vollmann, Dirk; Seegers, Joachim; Sohns, Christian; Hasenfuß, Gerd; Zabel, Markus

2015-08-01

Only limited comparative data exist on the benefits of fluid monitoring (FM) combined with remote monitoring (RM) regarding morbidity and mortality of heart failure (HF) patients. This prospective single-centre randomized pilot study aimed to estimate the influence of RM in combination with FM on HF hospitalizations as well as ventricular tachyarrhythmias and mortality. Patients with standard indication for implantable cardioverter defibrillator (ICD) or cardiac resynchronization therapy and defibrillator were implanted with devices capable of RM and FM, and were followed for 15 months. Subjects were randomly allocated to RM including OptiVol and predefined management of alerts (remote group), or standard in-office visits every 3 months (control group). A total of 176 patients (77% male; 66 ± 12 years; left ventricular ejection fraction (LVEF) 32 ± 11%; ischemic cardiomyopathy 50%; CRT device 50%; primary prevention 85%) were analysed. Cox proportional hazard analysis on the time to first HF-related hospitalization showed a hazard ratio of 1.23 [0.62-2.44] (P = 0.551) favouring the control group. In the remote group, 13 patients (15%) experienced ICD shocks vs. 10 patients (11%) in the control group (P = 0.512). The average time to first ICD shock was 212 ± 173 days in the remote arm and 212 ± 143 days in the control arm (P = 0.994). The Kaplan-Meier estimate of mortality after 1 year was 8.6% (eight deaths) in the remote group vs. 4.6% in the control group (six deaths; P = 0.502). In a single-centre randomized pilot study of RM in combination with FM, no significant influence on HF-related hospitalizations, ICD shocks, or mortality was found. Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2015. For permissions please email: journals.permissions@oup.com.

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

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

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 feasibility of conducting a randomised controlled trial comparing arthroscopic hip surgery to conservative care for patients with femoroacetabular impingement syndrome: the FASHIoN feasibility study.

PubMed

Griffin, D R; Dickenson, E J; Wall, P D H; Realpe, A; Adams, A; Parsons, N; Hobson, R; Achten, J; Costa, M L; Foster, N E; Hutchinson, C E; Petrou, S; Donovan, J L

2016-10-01

To determine whether it was feasible to perform a randomized controlled trial (RCT) comparing arthroscopic hip surgery to conservative care in patients with femoroacetabular impingement (FAI). This study had two phases: a pre-pilot and pilot RCT. In the pre-pilot, we conducted interviews with clinicians who treated FAI and with FAI patients to determine their views about an RCT. We developed protocols for operative and conservative care. In the pilot RCT, we determined the rates of patient eligibility, recruitment and retention, to investigate the feasibility of the protocol and we established methods to assess treatment fidelity. In the pre-pilot phase, 32 clinicians were interviewed, of which 26 reported theoretical equipoise, but in example scenarios 7 failed to show clinical equipoise. Eighteen patients treated for FAI were also interviewed, the majority of whom felt that surgery and conservative care were acceptable treatments. Surgery was viewed by patients as a 'definitive solution'. Patients were motivated to participate in research but were uncomfortable about randomization. Randomization was more acceptable if the alternative was available at the end of the trial. In the pilot phase, 151 patients were assessed for eligibility. Sixty were eligible and invited to take part in the pilot RCT; 42 consented to randomization. Follow-up was 100% at 12 months. Assessments of treatment fidelity were satisfactory. An RCT to compare arthroscopic hip surgery with conservative care in patients with FAI is challenging but feasible. Recruitment has started for a full RCT.

Amnioinfusion in very early preterm prelabor rupture of membranes (AMIPROM): pregnancy, neonatal and maternal outcomes in a randomized controlled pilot study.

PubMed

Roberts, D; Vause, S; Martin, W; Green, P; Walkinshaw, S; Bricker, L; Beardsmore, C; Shaw, N; McKay, A; Skotny, G; Williamson, P; Alfirevic, Z

2014-05-01

To assess short- and long-term outcomes of pregnant women with very early rupture of membranes randomized to serial amnioinfusion or expectant management, and to collect data to inform a larger, more definitive clinical trial. This was a prospective non-blinded randomized controlled trial with randomization stratified for pregnancies in which the membranes ruptured between 16 + 0 and 19 + 6 weeks' gestation and 20 + 0 and 23 + 6 weeks' gestation to minimize the risk of random imbalance in gestational age distribution between randomized groups. Intention-to-treat analysis was used. The study was conducted in four UK hospital-based fetal medicine units (Liverpool Women's NHS Trust, St Mary's Hospital Manchester, Birmingham Women's NHS Foundation Trust and Wirral University Hospitals Trust). The participants were women with confirmed preterm prelabor rupture of membranes at 16 + 0 to 24 + 0 weeks' gestation. Women with multiple pregnancy, fetal abnormality or obstetric indication for immediate delivery were excluded. Participants were randomly allocated to either serial weekly transabdominal amnioinfusions if the deepest pool of amniotic fluid was < 2 cm or expectant management until 37 weeks' gestation. Short-term maternal, pregnancy and neonatal and long-term outcomes for the child were studied. Long-term respiratory morbidity was assessed using validated respiratory questionnaires at 6, 12 and 18 months of age and infant lung function test at around 12 months of age. Neurodevelopment was assessed using the Bayley Scales of Infant Development, second edition (BSID-II) at corrected age of 2 years. Fifty-eight women were randomized to the study. Two babies were excluded from the analysis because of termination of pregnancy for lethal anomaly, leaving 56 participants (28 assigned to serial amnioinfusion and 28 to expectant management) recruited between 2002 and 2009. There was no significant difference in perinatal mortality (19/28 vs 19/28; relative risk (RR) 1.0 (95% CI, 0.70-1.43)) and maternal or neonatal morbidity. The overall chance of surviving without long-term respiratory or neurodevelopmental disability was 4/56 (7.1%); 4/28 (14.3%) in the amnioinfusion group and 0/28 in the expectant group (RR 9.0 (95% CI, 0.51-159.70)). This pilot study found no major differences in maternal, perinatal or pregnancy outcomes. The study was not designed to show a difference between the groups and the number of survivors was too small to draw any conclusions about long-term outcomes. It does, however, signal that a larger definitive study to evaluate amnioinfusion for improvement in healthy survival is needed. The pilot suggests that, with appropriate funding, such a study is feasible. Copyright © 2013 ISUOG. Published by John Wiley & Sons Ltd.

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.

EEG Neurofeedback for ADHD: Double-Blind Sham-Controlled Randomized Pilot Feasibility Trial

ERIC Educational Resources Information Center

Arnold, L. Eugene; Lofthouse, Nicholas; Hersch, Sarah; Pan, Xueliang; Hurt, Elizabeth; Bates, Bethany; Kassouf, Kathleen; Moone, Stacey; Grantier, Cara

2013-01-01

Objective: Preparing for a definitive randomized clinical trial (RCT) of neurofeedback (NF) for ADHD, this pilot trial explored feasibility of a double-blind, sham-controlled design and adherence/palatability/relative effect of two versus three treatments/week. Method: Unmedicated 6- to 12-year-olds with "Diagnostic and Statistical Manual of…

The analysis of the pilot's cognitive and decision processes

NASA Technical Reports Server (NTRS)

Curry, R. E.

1975-01-01

Articles are presented on pilot performance in zero-visibility precision approach, failure detection by pilots during automatic landing, experiments in pilot decision-making during simulated low visibility approaches, a multinomial maximum likelihood program, and a random search algorithm for laboratory computers. Other topics discussed include detection of system failures in multi-axis tasks and changes in pilot workload during an instrument landing.

Comparison of liraglutide plus basal insulin and basal-bolus insulin therapy (BBIT) for glycemic control, body weight stability, and treatment satisfaction in patients treated using BBIT for type 2 diabetes without severe insulin deficiency: A randomized prospective pilot study.

PubMed

Yamamoto, Saki; Hayashi, Toshiyuki; Ohara, Makoto; Goto, Satoshi; Sato, Jun; Nagaike, Hiroe; Fukase, Ayako; Sato, Nobuko; Hiromura, Munenori; Tomoyasu, Masako; Nakanishi, Noriko; Lee, Soushou; Osamura, Anna; Yamamoto, Takeshi; Fukui, Tomoyasu; Hirano, Tsutomu

2018-03-26

We examined whether 0.9 mg/day liraglutide plus basal insulin (Lira-basal) is superior to basal-bolus insulin therapy (BBIT) for type 2 diabetes (T2DM) without severe insulin deficiency as determined by glucagon stimulation. Fifty patients receiving BBIT were enrolled in this 24-week, prospective, randomized, open-labeled study. After excluding subjects with fasting C-peptide immunoreactivity (CPR) < 1.0 ng/mL and CPR increase < 1.0 ng/mL at 6 min post glucagon injection, 25 were randomly allocated to receive Lira-basal (n = 12) or continued BBIT (n = 13). Primary endpoint was change in HbA1c. Secondary endpoints were changes in body weight (BW), 7-point self-monitored blood glucose (SMBG), and Diabetes Treatment Satisfaction Questionnaire status (DTSQs) scores. The Lira-basal group demonstrated reduced HbA1c, whereas the BBIT group showed no change. BW was reduced in the Lira-basal group but increased in the BBIT group. The Lira-basal group also exhibited significantly reduced pre-breakfast and pre-lunch SMBG. DTSQs scores improved in the Lira-basal group but not the BBIT group. Plasma lipids, liver function, and kidney function were not significantly changed in either group. Lira-basal therapy is superior to BBIT for T2DM without severe insulin deficiency. This study was registered with UMIN Clinical Trials Registry (UMIN000028313). Copyright © 2018 The Authors. Published by Elsevier B.V. All rights reserved.

C2 Nerve Field Stimulation for the Treatment of Fibromyalgia: A Prospective, Double-blind, Randomized, Controlled Cross-over Study.

PubMed

Plazier, Mark; Ost, Jan; Stassijns, Gaëtane; De Ridder, Dirk; Vanneste, Sven

2015-01-01

Fibromyalgia is a condition characterized by widespread chronic pain. Due to the high prevalence and high costs, it has a substantial burden on society. Treatment results are diverse and only help a small subset of patients. C2 nerve field stimulation, aka occipital nerve stimulation, is helpful and a minimally invasive treatment for primary headache syndromes. Small C2 pilot studies seem to be beneficial in fibromyalgia. Forty patients were implanted with a subcutaneous electrode in the C2 dermatoma as part of a prospective, double-blind, randomized, controlled cross-over study followed by an open label follow up period of 6 months. The patients underwent 2 week periods of different doses of stimulation consisting of minimal (.1 mA), subthreshold, and suprathreshold (for paresthesias) in a randomized order. Twenty seven patients received a permanent implant and 25 completed the 6 month open label follow up period. During the 6 week trial phase of the study, patients had an overall decrease of 36% on the fibromyalgia impact questionnaire (FIQ), a decrease of 33% fibromyalgia pain and improvement of 42% on the impact on daily life activities and quality. These results imply an overall improvement in the disease burden, maintained at 6 months follow up, as well as an improvement in life quality of 50%. Seventy six percent of patients were satisfied or very satisfied with their treatment. There seems to be a dose-response curve, with increasing amplitudes leading to better clinical outcomes. Subcutaneous C2 nerve field stimulation seems to offer a safe and effective treatment option for selected medically intractable patients with fibromyalgia. Copyright © 2015 Elsevier Inc. All rights reserved.

Mobile Health Technology for Atrial Fibrillation Management Integrating Decision Support, Education, and Patient Involvement: mAF App Trial.

PubMed

Guo, Yutao; Chen, Yundai; Lane, Deirdre A; Liu, Lihong; Wang, Yutang; Lip, Gregory Y H

2017-12-01

Mobile Health technology for the management of patients with atrial fibrillation is unknown. The simple mobile AF (mAF) App was designed to incorporate clinical decision-support tools (CHA 2 DS 2 -VASc [Congestive heart failure, Hypertension, Age ≥75 years, Diabetes Mellitus, Prior Stroke or TIA, Vascular disease, Age 65-74 years, Sex category], HAS-BLED [Hypertension, Abnormal renal/liver function, Stroke, Bleeding history or predisposition, Labile INR, Elderly, Drugs/alcohol concomitantly], SAMe-TT 2 R 2 [Sex, Age <60 years, Medical history, Treatment, Tobacco use, Race] scores), educational materials, and patient involvement strategies with self-care protocols and structured follow-up. Patients with atrial fibrillation were randomized into 2 groups (mAF App vs usual care) in a cluster randomized design pilot study. Patients' knowledge, quality of life, drug adherence, and anticoagulation satisfaction were evaluated at baseline, 1 month, and 3 months. Usability, feasibility, and acceptability of the mAF App were assessed at 1 month. A total of 113 patients were randomized to mAF App intervention (mean age, 67.4 years; 57.5% were male; mean follow-up, 69 days), and 96 patients were randomized to usual care (mean age, 70.9 years; 55.2% were male; mean follow-up, 95 days). More than 90% of patients reported that the mAF App was easy, user-friendly, helpful, and associated with significant improvements in knowledge compared with the usual care arm (P values for trend <.05). Drug adherence and anticoagulant satisfaction were significantly better with the mAF App versus usual care (all P < .05). Quality of life scores were significantly increased in the mAF App arm versus usual care, with anxiety and depression reduced (all P < .05). The pilot mAFA Trial is the first prospective randomized trial of Mobile Health technology in patients with atrial fibrillation, demonstrating that the mAF App, integrating clinical decision support, education, and patient-involvement strategies, significantly improved knowledge, drug adherence, quality of life, and anticoagulation satisfaction. Copyright © 2017 The Authors. Published by Elsevier Inc. All rights reserved.

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...

Emotion Regulation Enhancement of Cognitive Behavior Therapy for College Student Problem Drinkers: A Pilot Randomized Controlled Trial

ERIC Educational Resources Information Center

Ford, Julian D.; Grasso, Damion J.; Levine, Joan; Tennen, Howard

2018-01-01

This pilot randomized clinical trial tested an emotion regulation enhancement to cognitive behavior therapy (CBT) with 29 college student problem drinkers with histories of complex trauma and current clinically significant traumatic stress symptoms. Participants received eight face-to-face sessions of manualized Internet-supported CBT for problem…

Aquatic Physical Therapy for Children with Developmental Coordination Disorder: A Pilot Randomized Controlled Trial

ERIC Educational Resources Information Center

Hillier, Susan; McIntyre, Auburn; Plummer, Leanne

2010-01-01

Aquatic therapy is an intervention for children with Developmental Coordination Disorder (DCD) that has not been investigated formally. This was a pilot randomized controlled trial to investigate the feasibility and preliminary effectiveness of an aquatic therapy program to improve motor skills of children with DCD. Thirteen children (mean age 7…

Laparoscopic Surgical Treatment of Severe Obesity Combined with Gastroesophageal Reflux Disease: A Pilot Randomized Two-Arm Controlled Clinical Study

ERIC Educational Resources Information Center

Ospanov, Oral B.; Orekeshova, Akzhunis M.; Fursov, Roman A.; Yelemesov, Aset A.

2016-01-01

Obesity and gastroesophageal reflux disease (GERD) are serious medical, social, and economic problems of modern society. A pilot randomized two-arm controlled clinical study was conducted to compare laparoscopic plication of the greater gastric curvature combined with Nissen fundoplication (LFN+LGP) versus only Nissen fundoplication (LFN). The…

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.

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

PROMOTING SUPPORTIVE PARENTING IN NEW MOTHERS WITH SUBSTANCE-USE PROBLEMS: A PILOT RANDOMIZED TRIAL OF RESIDENTIAL TREATMENT PLUS AN ATTACHMENT-BASED PARENTING PROGRAM

PubMed Central

BERLIN, LISA J.; SHANAHAN, MEGHAN; CARMODY, KAREN APPLEYARD

2015-01-01

This pilot randomized trial tested the feasibility and efficacy of supplementing residential substance-abuse treatment for new mothers with a brief, yet rigorous, attachment-based parenting program. Twenty-one predominantly (86%) White mothers and their infants living together in residential substance-abuse treatment were randomly assigned to the program (n = 11) or control (n = 10) group. Program mothers received 10 home-based sessions of Dozier’s Attachment and Biobehavioral Catch-up (ABC) intervention. Postintervention observations revealed more supportive parenting behaviors among the randomly assigned ABC mothers. PMID:25424409

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.

Flight Simulator Visual-Display Delay Compensation

NASA Technical Reports Server (NTRS)

Crane, D. Francis

1981-01-01

A piloted aircraft can be viewed as a closed-loop man-machine control system. When a simulator pilot is performing a precision maneuver, a delay in the visual display of aircraft response to pilot-control input decreases the stability of the pilot-aircraft system. The less stable system is more difficult to control precisely. Pilot dynamic response and performance change as the pilot attempts to compensate for the decrease in system stability. The changes in pilot dynamic response and performance bias the simulation results by influencing the pilot's rating of the handling qualities of the simulated aircraft. The study reported here evaluated an approach to visual-display delay compensation. The objective of the compensation was to minimize delay-induced change in pilot performance and workload, The compensation was effective. Because the compensation design approach is based on well-established control-system design principles, prospects are favorable for successful application of the approach in other simulations.

THE EFFECTIVENESS OF PILOT PROGRAMS COMPARED TO OTHER PROGRAMS OF VOCATIONAL AGRICULTURE IN TENNESSEE.

ERIC Educational Resources Information Center

LEGG, OTTO

THE OBJECTIVE OF THIS COMPARATIVE STUDY WAS TO EVALUATE THE RELATIVE EFFECTIVENESS OF TENNESSEE VOCATIONAL AGRICULTURE PROGRAMS IN FOUR CATEGORIES -- (1) PILOT SCHOOLS, (2) LIKE-PILOT SCHOOLS OR SCHOOLS RESEMBLING PILOT SCHOOLS, (3) STUDENT TEACHING CENTERS, AND (4) NEGRO SCHOOLS. THE RANDOM SAMPLE INCLUDED 800 STUDENTS FROM 20 SCHOOLS DIVIDED…

Safety and tolerance of a probiotic formula in early infancy comparing two probiotic agents: a pilot study.

PubMed

Weizman, Zvi; Alsheikh, Ahmed

2006-10-01

To compare the safety and tolerance of two formulas, supplemented with different probiotic agents, in early infancy. Prospective randomized placebo-controlled trial. Clinics of a University Medical Center. Full-term healthy infants aged less than 4 months. Infants were randomly assigned for 4 weeks to a standard milk-based formula supplemented with either Bifidobacterium lactis (BB-12), Lactobacillus reuteri (ATCC 55730) or a probiotics-free formula. Growth parameters, daily characteristics of feeding, stooling and behavior, and side effects. Fifty-nine infants, aged 3-65 days, were included. Subjects in all three groups were similar at entry in terms of gestational age, birth weight, sex, growth parameters and breast feeding rate prior to the study. The supplemented formulas were well accepted and did not reveal any adverse effects. A comparison of growth parameters, and variables of feeding, stooling and crying and irritability did not reveal any significant differences between groups. The use of formula supplemented with either Lactobacillus reuteri or Bifidobacterium lactis in early infancy, was safe, well tolerated and did not adversely affect growth, stooling habits or infant behavior.

Stress Management-Augmented Behavioral Weight Loss Intervention for African American Women: A Pilot, Randomized Controlled Trial

ERIC Educational Resources Information Center

Cox, Tiffany L.; Krukowski, Rebecca; Love, ShaRhonda J.; Eddings, Kenya; DiCarlo, Marisha; Chang, Jason Y.; Prewitt, T. Elaine; West, Delia Smith

2013-01-01

The relationship between chronic stress and weight management efforts may be a concern for African American (AA) women, who have a high prevalence of obesity, high stress levels, and modest response to obesity treatment. This pilot study randomly assigned 44 overweight/obese AA women with moderate to high stress levels to either a 12-week…

Changing Parent's Mindfulness, Child Management Skills and Relationship Quality with Their Youth: Results from a Randomized Pilot Intervention Trial

ERIC Educational Resources Information Center

Coatsworth, J. Douglas; Duncan, Larissa G.; Greenberg, Mark T.; Nix, Robert L.

2010-01-01

We evaluated the efficacy of a mindful parenting program for changing parents' mindfulness, child management practices, and relationships with their early adolescent youth and tested whether changes in parents' mindfulness mediated changes in other domains. We conducted a pilot randomized trial with 65 families and tested an adapted version of the…

Randomized Controlled Trial of Problem-Solving Therapy for Minor Depression in Home Care

ERIC Educational Resources Information Center

Gellis, Zvi D.; McGinty, Jean; Tierney, Lynda; Jordan, Cindy; Burton, Jean; Misener, Elizabeth

2008-01-01

Objective: Data are presented from a pilot research program initiated to develop, refine, and test the outcomes of problem-solving therapy that targets the needs of older adults with minor depression in home care settings. Method: A pilot randomized clinical trial compares the impact of problem-solving therapy for home care to treatment as usual…

Randomized Controlled Trial for Early Intervention for Autism: A Pilot Study of the Autism 1-2-3 Project

ERIC Educational Resources Information Center

Wong, Virginia C. N.; Kwan, Queenie K.

2010-01-01

We piloted a 2-week "Autism-1-2-3" early intervention for children with autism and their parents immediately after diagnosis that targeted at (1) eye contact, (2) gesture and (3) vocalization/words. Seventeen children were randomized into the Intervention (n = 9) and Control (n = 8) groups. Outcome measures included the Autism Diagnostic…

The Impact of a Computer-Mediated Shadowing Activity on ESL Speaking Skill Development: A Pilot Study

ERIC Educational Resources Information Center

Mishima, Masakazu; Cheng, Lixia

2017-01-01

This pilot study explored the instructional value and potential of a computer-mediated shadowing activity for improving English as a Second Language (ESL) learners' speech intelligibility. Prospective International Teaching Assistants (ITAs), who were enrolled in an ESL classroom communication class at a large public university, completed a…

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

A Pilot Randomized Controlled Trial on the Effects of a Progressive Exercise Program on the Range of Motion and Upper Extremity Grip Strength in Young Adults With Breast Cancer.

PubMed

Ibrahim, Marize; Muanza, Thierry; Smirnow, Nadia; Sateren, Warren; Fournier, Beatrice; Kavan, Petr; Palumbo, Michael; Dalfen, Richard; Dalzell, Mary-Ann

2018-02-01

The diagnosis of breast cancer in young women (aged 18-45 years) has been increasing. Women are commonly left coping with treatment-related disabilities of the upper limb that can persist for > 2 years postoperatively. A total of 59 young breast cancer patients (29 in the intervention group and 30 in the control group) participated in a pilot prospective randomized controlled trial to determine whether a 12-week postradiation exercise program would improve long-term arm mobility, pain, and handgrip strength. During an 18-month period, range of motion, handgrip strength, and pain with shoulder movements were evaluated at 6 points. Although the differences were not statistically significant, external rotation and horizontal abduction of the shoulder improved in the intervention group immediately after the exercise intervention (3 months) and showed a trend toward less pain on movement. However, at 18 months after radiation the control and intervention groups both retained a residual loss of range and persistent pain with movement. Radiation to the axilla and/or chest wall yielded long-term (18 months) limitations in flexion and horizontal abduction compared with hypofractionation, which resulted in greater flexion and external rotation at 18 months. The median grip strength of the study participants corresponded to the 10th percentile of healthy aged-matched white women. The exercise intervention timed shortly after radiation improved short-term shoulder mobility and pain; however, these gains were not sustained at 18 months after radiation. Copyright © 2017 Elsevier Inc. All rights reserved.

Feasibility of the Use of Transesophageal Echocardiography as a Surface Probe for Puncturing and Catheterization of the Internal Jugular Vein: A Randomized Controlled Pilot Study.

PubMed

Teng, Yi; Ou, Mengchan; Yu, Hai

2018-02-01

To compare the transesophageal echocardiography (TEE) probe as a surface probe with the vascular probe for guiding internal jugular vein (IJV) catheterization. Prospective, randomized, controlled pilot study. University hospital. One hundred cardiac surgery patients, including 50 adult and 50 pediatric patients. Patients in the TEE probe group received right IJV catheterization using the TEE probe, while the vascular probe group used the vascular probe for catheterization. The puncture time, first-attempt success rate, quality of the imaging with needle tip positioning, wire positioning, and catheter positioning were recorded. The incidence of complication or any adverse event also was observed. Adult patients: In the vascular probe group, the success rate for first attempt IJV catheterization was 24/25 (96%), while in the TEE probe group, the success rate for first attempt IJV catheterization was 25/25 (100%). There was no statistical difference in the puncture time, image quality, needle tip positioning, wire positioning, and catheter positioning between groups (p > 0.05). Pediatric patients: The success rate for first-attempt IJV catheterization was 100% in both groups, and there were no statistical differences in the puncture time, image quality, and positioning between the 2 groups (p > 0.05). No complications or adverse events were observed in either group. The TEE probe, used as a surface probe, can be used to guide IJV puncturing and catheterization in cardiac surgery patients with favorable feasibility and safety. Copyright © 2018 Elsevier Inc. All rights reserved.

Tailored activities to manage neuropsychiatric behaviors in persons with dementia and reduce caregiver burden: a randomized pilot study.

PubMed

Gitlin, Laura N; Winter, Laraine; Burke, Janice; Chernett, Nancy; Dennis, Marie P; Hauck, Walter W

2008-03-01

To test whether the Tailored Activity Program (TAP) reduces dementia-related neuropsychiatric behaviors, promotes activity engagement, and enhances caregiver well-being. Prospective, two-group (treatment, wait-list control), randomized, controlled pilot study with 4 months as main trial endpoint. At 4 months, controls received the TAP intervention and were reassessed 4 months later. Patients' homes. Sixty dementia patients and family caregivers. The eight-session occupational therapy intervention involved neuropsychological and functional testing, selection, and customization of activities to match capabilities identified in testing, and instruction to caregivers in use of activities. Behavioral occurrences, activity engagement, and quality of life in dementia patients; objective and subjective burden and skill enhancement in caregivers. At 4 months, compared with controls, intervention caregivers reported reduced frequency of problem behaviors, and specifically for shadowing and repetitive questioning, and greater activity engagement including the ability to keep busy. Fewer intervention caregivers reported agitation or argumentation. Caregiver benefits included fewer hours doing things and being on duty, greater mastery, self-efficacy, and skill enhancement. Wait-list control participants following intervention showed similar benefits for reductions in behavioral frequency and caregiver hours doing things for the patient and mastery. Caregivers with depressed symptoms derived treatment benefits similar to nondepressed caregivers. Tailoring activities to the capabilities of dementia patients and training families in activity use resulted in clinically relevant benefits for patients and caregivers. Treatment minimized trigger behaviors for nursing home placement and reduced objective caregiver burden. Noteworthy is that depressed caregivers effectively engaged in and benefited from the intervention.

Tailored Activities to Manage Neuropsychiatric Behaviors in Persons with Dementia and Reduce Caregiver Burden: A Randomized Pilot Study

PubMed Central

Gitlin, Laura N.; Winter, Laraine; Burke, Janice; Chernett, Nancy; Dennis, Marie P.; Hauck, Walter W.

2009-01-01

Objective To test whether the Tailored Activity Program for at-home dementia patients reduces neuropsychiatric behaviors and caregiver burden. Method A prospective, two-group controlled pilot study with 60 dyads randomized to treatment or wait-list control. Dyads were interviewed at baseline and 4 months (trial endpoint); control participants then received intervention and were reassessed 4 months later. The 8-session occupational therapy intervention involved neuropsychological and functional testing from which activities were customized and instruction in use provided to caregivers. Results At 4-months, compared to controls, intervention caregivers reported reduced frequency of behaviors (p = .010; Cohen’s d = .72), specifically for shadowing (p = .003, Cohen’s d = 3.10) and repetitive questioning (p = .23, Cohen’s d = 1.22); greater activity engagement (p = .029, Cohen’s d = .61); and ability to keep busy (p = .017, Cohen’s d = .71). Also, fewer intervention caregivers reported agitation (p = .014, Cohen’s d = .75) or argumentation (p = .010, Cohen’s d = .77). Caregiver benefits included fewer hours doing things (p = .005, Cohen’s d = 1.14) and being on duty (p = .001, Cohen’s d = 1.01), greater mastery (p = .013, Cohen’s d = .55), self-efficacy (p = .011, Cohen’s d = .74), and use of simplification techniques (p = .023, Cohen’s d = .71). Wait-list control participants showed similar benefits for behavioral frequency following intervention. Conclusions Results suggest clinically-relevant benefits for both dementia patients and caregivers, with treatment minimizing the occurrence of behaviors that commonly trigger nursing home placement. PMID:18310553

Intravenous Insulin Decreases Protein Breakdown in Infants on Extracorporeal Membrane Oxygenation

PubMed Central

Agus, Michael S.D.; Javid, Patrick J.; Ryan, Daniel P.; Jaksic, Tom

2010-01-01

Background/Purpose Infants requiring extracorporeal membrane oxygenation (ECMO) have the highest rates of protein catabolism ever reported. Recent investigations have found that such extreme protein breakdown is refractory to conventional nutritional management. In this pilot study, the authors sought to use the anabolic hormone insulin to reduce the profound protein degradation in this cohort. Methods Four parenterally fed infants on ECMO were enrolled in a prospective, randomized, crossover trial. Subjects were administered an insulin infusion using a 4-hour hyperinsulinemic euglycemic clamp followed by a control saline infusion on consecutive days in random order. Whole-body protein flux and breakdown were quantified using a primed continuous infusion of the stable isotope l-[1-13C]leucine. Statistical analyses were performed using paired t tests. Results Serum insulin levels were increased 15-fold during the insulin clamp compared with the saline control (407 ± 103 v 26 ± 12 µU/mL; P < .05). During the insulin infusion, infants had decreased rates of total leucine flux (214 ± 25 v 298 ± 38 µmol/kg/h; P < .05) and leucine flux derived from protein breakdown (156 ± 40 v 227 ± 54 µmol/kg/h; P < .05) when compared with saline control. Overall, insulin administration produced a 32% reduction in protein breakdown (P < .05). Conclusions In this pilot study, the anabolic hormone insulin markedly reduced protein breakdown in critically ill infants on ECMO. Because elevated protein breakdown correlates with mortality and morbidity, the administration of intravenous insulin may ultimately have broad applicability to the metabolic management of critically ill infants. PMID:15185208

The effects of enhanced hexapod motion on airline pilot recurrent training and evaluation

DOT National Transportation Integrated Search

2003-08-13

A quasi-transfer experiment tested the effect of : simulator motion on recurrent evaluation and training : of airline pilots. Two groups of twenty B747-400 pilots : were randomly assigned to a flight simulator with or : without platform motion. In th...

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.

Security scheme in IMDD-OFDM-PON system with the chaotic pilot interval and scrambling

NASA Astrophysics Data System (ADS)

Chen, Qianghua; Bi, Meihua; Fu, Xiaosong; Lu, Yang; Zeng, Ran; Yang, Guowei; Yang, Xuelin; Xiao, Shilin

2018-01-01

In this paper, a random chaotic pilot interval and permutations scheme without any requirement of redundant sideband information is firstly proposed for the physical layer security-enhanced intensity modulation direct detection orthogonal frequency division multiplexing passive optical network (IMDD-OFDM-PON) system. With the help of the position feature of inserting the pilot, a simple logistic chaos map is used to generate the random pilot interval and scramble the chaotic subcarrier allocation of each column pilot data for improving the physical layer confidentiality. Due to the dynamic chaotic permutations of pilot data, the enhanced key space of ∼103303 is achieved in OFDM-PON. Moreover, the transmission experiment of 10-Gb/s 16-QAM encrypted OFDM data is successfully demonstrated over 20-km single-mode fiber, which indicates that the proposed scheme not only improves the system security, but also can achieve the same performance as in the common IMDD-OFDM-PON system without encryption scheme.

Pilot study of once-daily simplification therapy with abacavir/lamivudine/zidovudine and efavirenz for treatment of HIV-1 infection.

PubMed

Ruane, Peter; Lang, Joseph; DeJesus, Edwin; Berger, Daniel S; Dretler, Robin; Rodriguez, Allan; Ward, Douglas J; Lim, Michael L; Liao, Qiming; Reddy, Sunila; Clair, Marty St; Vila, Tania; Shaefer, Mark S

2006-01-01

The purpose of this pilot study was to explore the efficacy and safety of the abacavir/lamivudine/zidovudine fixed-dose combination tablet administered as two tablets once daily (qd) versus one tablet twice daily (bid) in combination with efavirenz (EFV). This was a prospective, randomized, open-label, multicenter study with a 24-week treatment period in 7 outpatient HIV clinics in the United States. Patients currently receiving an initial regimen of abacavir/lamivudine/zidovudine bid plus EFV qd for at least 6 months with HIV-1 RNA <50 copies/mL for at least 3 months and a screening CD4+ cell count > or = 200 cells/mm3 were eligible. Thirty-six patients enrolled, and 35 (97%) completed the study. Participants were randomized to switch to 2 tablets of abacavir/lamivudine/zidovudine qd plus EFV qd (QD arm) or continue current treatment (BID arm) for 24 weeks. Efficacy, safety, and adherence were evaluated. Median baseline CD4+ cell count was 521 cells/mm3. At week 24, HIV-1 RNA <50 copies/mL was achieved for 94% of participants in the QD arm and 89% in the BID arm by intent-to-treat, missing = failure analysis (95% confidence interval for difference: > or = 0.29 to +0.18, p = 1.000). At week 24, median CD4+ cell count change from baseline was +26 cells/mm3 for the QD arm and -39 cells/mm3 for BID arm. One patient randomized to the QD arm met virologic failure criteria (confirmed HIV-1 RNA >120 copies/mL) at week 20 and viral genotype showed M184V. After failure, this patient revealed he never took EFV throughout the entire study after randomization, effectively receiving only abacavir/lamivudine/zidovudine qd alone. Median adherence was slightly higher in the QD arm, although both arms had broad variability and overlapping interquartile ranges. Adverse events were infrequent and occurred with similar frequency between arms; treatment-related adverse events were abdominal pain, flatulence, nausea, headache, and abnormal dreams (1 patient [3%] for each adverse event). No patients withdrew due to adverse events, and no abacavir hypersensitivity reactions were reported. In this pilot study of patients suppressed on abacavir/lamivudine/zidovudine bid plus EFV, 94% of participants switching to abacavir/lamivudine/zidovudine qd plus EFV maintained virologic suppression, compared to 89% of participants continuing abacavir/lamivudine/zidovudine bid plus EFV.

Recruitment and accrual of women in a placebo-controlled clinical pilot study on manual therapy.

PubMed

Cambron, Jerrilyn A; Hawk, Cheryl; Evans, Roni; Long, Cynthia R

2004-06-01

To investigate the accrual rates and recruitment processes among 3 Midwestern sites during a pilot study on manual therapy for chronic pelvic pain. Multisite pilot study for a randomized, placebo-controlled clinical trial. Three chiropractic institutions in or near major metropolitan cities in the Midwestern United States. Thirty-nine women aged 18 to 45 with chronic pelvic pain of at least 6 months duration, diagnosed by a board certified gynecologist. The method of recruitment was collected for each individual who responded to an advertisement and completed an interviewer-administered telephone screen. Participants who were willing and eligible after 3 baseline visits were entered into a randomized clinical trial. The number of responses and accrual rates were determined for the overall study, each of the 3 treatment sites, and each of the 5 recruitment efforts. In this study, 355 women were screened over the telephone and 39 were randomized, making the rate of randomization approximately 10%. The most effective recruitment methods leading to randomization were direct mail (38%) and radio advertisements (34%). However, success of the recruitment process differed by site. Based on the accrual of this multisite pilot study, a full-scale trial would not be feasible using this study's parameters. However, useful information was gained on recruitment effectiveness, eligibility criteria, and screening protocols among the 3 metropolitan sites.

A Pilot Randomized Controlled Trial of Omega-3 Fatty Acids for Autism Spectrum Disorder

ERIC Educational Resources Information Center

Bent, Stephen; Bertoglio, Kiah; Ashwood, Paul; Bostrom, Alan; Hendren, Robert L.

2011-01-01

We conducted a pilot randomized controlled trial to determine the feasibility and initial safety and efficacy of omega-3 fatty acids (1.3 g/day) for the treatment of hyperactivity in 27 children ages 3-8 with autism spectrum disorder (ASD). After 12 weeks, hyperactivity, as measured by the Aberrant Behavior Checklist, improved 2.7 (plus or minus…

Virtual reality to augment robot-assisted gait training in non-ambulatory patients with a subacute stroke: a pilot randomized controlled trial.

PubMed

Bergmann, Jeannine; Krewer, Carmen; Bauer, Petra; Koenig, Alexander; Riener, Robert; Müller, Friedemann

2018-06-01

Active performance is crucial for motor learning, and, together with motivation, is believed to be associated with a better rehabilitation outcome. Virtual reality (VR) is an innovative approach to engage and motivate patients during training. There is promising evidence for its efficiency in retraining upper limb function. However, there is insufficient proof for its effectiveness in gait training. To evaluate the acceptability of robot-assisted gait training (RAGT) with and without VR and the feasibility of potential outcome measures to guide the planning of a larger randomized controlled trial (RCT). Single-blind randomized controlled pilot trial with two parallel arms. Rehabilitation hospital. Twenty subacute stroke patients (64±9 years) with a Functional Ambulation Classification (FAC) ≤2. Twelve sessions (over 4 weeks) of either VR-augmented RAGT (intervention group) or standard RAGT (control group). Acceptability of the interventions (drop-out rate, questionnaire), patients' motivation (Intrinsic Motivation Inventory [IMI], individual mean walking time), and feasibility of potential outcome measures (completion rate and response to interventions) were determined. We found high acceptability of repetitive VR-augmented RAGT. The drop-out rate was 1/11 in the intervention and 4/14 in the control group. Patients of the intervention group spent significantly more time walking in the robot than the control group (per session and total walking time; P<0.03). In both groups, motivation measured with the IMI was high over the entire intervention period. The felt pressure and tension significantly decreased in the intervention group (P<0.01) and was significantly lower than in the control group at the last therapy session (r=-0.66, P=0.005). The FAC is suggested as a potential primary outcome measure for a definitive RCT, as it could be assessed in all patients and showed significant response to interventions (P<0.01). We estimated a sample size of 44 for a future RCT. VR-augmented RAGT resulted in high acceptability and motivation, and in a reduced drop-out rate and an extended training time compared to standard RAGT. This pilot trial provides guidance for a prospective RCT on the effectiveness of VR-augmented RAGT. VR might be a promising approach to enrich and improve gait rehabilitation after stroke.

78 FR 52548 - The National Children's Study, Vanguard (Pilot) Study Proposed Collection; 60-day Comment Request

Federal Register 2010, 2011, 2012, 2013, 2014

2013-08-23

... the initiation of methodological substudies. The NCS Vanguard Study is a prospective, longitudinal pilot study of child health and development that will inform the design of the Main Study of the... variables and designed to collect core data at every study visit contact from the time that the enrolled...

Robotic Surgery Readiness (RSR): A Prospective Randomized Skills Decay Recognition and Prevention Study

DTIC Science & Technology

2016-08-01

AWARD NUMBER: W81XWH-15-2-0030 TITLE: Robotic Surgery Readiness (RSR): A Prospective Randomized Skills Decay Recognition and Prevention Study...20164. TITLE AND SUBTITLE Robotic Surgery Readiness (RSR): A Prospective Randomized Skills Decay 5a. CONTRACT NUMBER R ognition and Prevention Study...be recruited and many have completed the proficiency phase of this project and will be moving on to AIM 1. 15. SUBJECT TERMS Robotic Surgery

A Pilot Prospective Randomized Control Trial Comparing Exercises Using Videogame Therapy to Standard Physical Therapy: 6 Months Follow-Up.

PubMed

Parry, Ingrid; Painting, Lynda; Bagley, Anita; Kawada, Jason; Molitor, Fred; Sen, Soman; Greenhalgh, David G; Palmieri, Tina L

2015-01-01

Commercially available, interactive videogames that use body movements for interaction are used clinically in burn rehabilitation and have been shown to facilitate functional range of motion (ROM) but their efficacy with burn patients has not yet been proven. The purpose of this pilot randomized control study was to prospectively compare planar and functional ROM, compliance, pain, enjoyment, and exertion in pediatric burn patients receiving two types of rehabilitation therapy. Seventeen school-aged children with 31 affected limbs who demonstrated limited shoulder ROM from burn injury were randomized to receive exercises using either standard therapy ROM activities (ST) or interactive videogame therapy (VGT). Patients received 3 weeks of the designated therapy intervention twice daily. They were then given a corresponding home program of the same type of therapy to perform regularly for 6 months. Standard goniometry and three-dimensional motion analysis during functional tasks were used to assess ROM. Measures were taken at baseline, 3 weeks, 3 months, and 6 months. Pain was measured before and after each treatment session during the 3-week intervention. There was no difference in compliance, enjoyment, or exertion between the groups. Patients in both the ST and VGT groups showed significant improvement in shoulder flexion (P < .001), shoulder abduction (P <.001), shoulder external rotation (P = .01), and elbow flexion (P = .004) ROM from baseline to 6 months as measured with goniometry. Subjects also showed significant gains in elbow flexion (P = .04) during hand to head and shoulder flexion (P = .04) during high reach. There was no difference in ROM gains between the groups. Within group comparison showed that the VGT group had significantly more recovery of ROM during the first 3 weeks than any other timeframe in the study, whereas ST had most gains at 3 months. There was a significant difference between the groups in the subjects' pain response. ST subjects showed an increase in pain during the intervention, whereas VGT subjects did not (VGT: r = .047, ST: r = .18; P = .015). In this study, interactive videogames were equally effective as traditional therapy for overall ROM gains and resulted in quicker recovery of motion with less pain experienced. Such videogames are a useful adjunct to therapy and should be considered as part of a holistic approach to rehabilitation within the hospital and at home after discharge in pediatric patients recovering from burn injury.

Performance of zirconia ceramic cantilever fixed dental prostheses: 3-year results from a prospective, randomized, controlled pilot study.

PubMed

Zenthöfer, Andreas; Ohlmann, Brigitte; Rammelsberg, Peter; Bömicke, Wolfgang

2015-07-01

Little is known about the clinical performance of ceramic cantilever fixed dental prostheses on natural teeth. The purpose of this randomized controlled pilot study was to evaluate the clinical performance of ceramic and metal ceramic cantilever fixed dental prostheses (CFDPs) after 3 years of service. Twenty-one participants were randomly allocated to 2 treatment groups. Participants in the ceramic (ZC) group (n=11) each received 1 CFDP made of yttria-stabilized, tetragonal zirconia polycrystal; the others (n=10) were fitted with a metal ceramic (MC) CFDP. All CFDPs were retained by 2 complete crown abutments and replaced 1 tooth. The clinical target variables were survival, incidence of complications, probing pocket depth (PPD), probing attachment level (PAL), plaque index (PI), gingival index (GI), and esthetic performance as rated by the participants. The United States Public Health Service (USPHS) criteria were used to evaluate chipping, retention, color, marginal integrity, and secondary caries. Descriptive statistics and nonparametric analyses were applied to the target variables in the 2 groups. The esthetic performance of the CFDPs was also visualized by using a pyramid comparison. The overall survival of the CFDPs was 100% in both groups. During the 3-year study, 6 clinically relevant complications requiring aftercare were observed among 5 participants (4 in the ZC group and 2 in the MC group). Changes in the PI, GI, PPD, and PAL of the abutment teeth were similar for both groups (P>.05). The participants regarded the esthetic performance of ZC-CFDPs and MC-CFDPs as satisfactory. Within the 3-year observation period, the clinical performance of MC-FDPs and ZC-FDPs was acceptable. More extensive research with larger sample sizes is encouraged, however, to confirm the evaluation of the survival of Y-TZP hand-veneered cantilever FPDs. Copyright © 2015 Editorial Council for the Journal of Prosthetic Dentistry. Published by Elsevier Inc. All rights reserved.

Cerebral Oxygen Saturation to Guide Oxygen Delivery in Preterm Neonates for the Immediate Transition after Birth: A 2-Center Randomized Controlled Pilot Feasibility Trial.

PubMed

Pichler, Gerhard; Urlesberger, Berndt; Baik, Nariae; Schwaberger, Bernhard; Binder-Heschl, Corinna; Avian, Alexander; Pansy, Jasmin; Cheung, Po-Yin; Schmölzer, Georg Marcus

2016-03-01

To assess if monitoring of cerebral regional tissue oxygen saturation (crSO2) using near-infrared spectroscopy (NIRS) to guide respiratory and supplemental oxygen support reduces burden of cerebral hypoxia and hyperoxia in preterm neonates during resuscitation after birth. Preterm neonates <34(+0) weeks of gestation were included in a prospective randomized controlled pilot feasibility study at 2 tertiary level neonatal intensive care units. In a NIRS-visible group, crSO2 monitoring in addition to pulse oximetry was used to guide respiratory and supplemental oxygen support during the first 15 minutes after birth. In a NIRS-not-visible group, only pulse oximetry was used. The primary outcomes were burden of cerebral hypoxia (<10th percentile) or hyperoxia (>90th percentile) measured in %minutes crSO2 during the first 15 minutes after birth. Secondary outcomes were all cause of mortality and/or cerebral injury and neurologic outcome at term age. Allocation sequence was 1:1 with block-randomization of 30 preterm neonates at each site. In the NIRS-visible group burden of cerebral hypoxia in %minutes, crSO2 was halved, and the relative reduction was 55.4% (95% CI 37.6-73.2%; P = .028). Cerebral hyperoxia was observed in NIRS-visible group in 3 neonates with supplemental oxygen and in NIRS-not-visible group in 2. Cerebral injury rate and neurologic outcome at term age was similar in both groups. Two neonates died in the NIRS-not-visible group and none in the NIRS-visible group. No severe adverse reactions were observed. Reduction of burden of cerebral hypoxia during immediate transition and resuscitation after birth is feasible by crSO2 monitoring to guide respiratory and supplemental oxygen support. ClinicalTrials.gov: NCT02017691. Copyright © 2016 Elsevier Inc. All rights reserved.

Short-term therapy with combination dipeptidyl peptidase-4 inhibitor saxagliptin/metformin extended release (XR) is superior to saxagliptin or metformin XR monotherapy in prediabetic women with polycystic ovary syndrome: a single-blind, randomized, pilot study.

PubMed

Elkind-Hirsch, Karen E; Paterson, Martha S; Seidemann, Ericka L; Gutowski, Hanh C

2017-01-01

To evaluate efficacy with the dipeptidyl peptidase-4 inhibitor saxagliptin (SAXA), metformin extended release (MET), and combination (SAXA-MET) in patients with polycystic ovary syndrome (PCOS) and impaired glucose regulation. Prospective, randomized, single-blind drug study. Outpatient clinic. Patients (n = 38) with PCOS (aged 18-42 years) and prediabetic hyperglycemia determined by a 75-gram oral glucose tolerance test. Patients were randomized to SAXA-MET (5 mg/2,000 mg), SAXA (5 mg), or MET (2,000 mg) for 16 weeks. Fasting and mean blood glucose, insulin sensitivity, insulin secretion, and insulin secretion-sensitivity index (IS-SI) by oral glucose tolerance tests. Free androgen index and lipid levels, average menstrual interval, and anthropometric measurements (body mass index, waist circumference, and waist/height ratio). The study was completed by 34 patients. Nineteen patients had normal glucose tolerance: 3 of 12 (25%) on MET; 6 of 11 (55%) on SAXA; and 10 of 11 (91%) on SAXA-MET (SAXA-MET statistically superior to MET) at study completion. Body mass index, waist circumference, waist/height ratio, free androgen index, insulin sensitivity, IS-SI, and menses improved in all groups; however, IS-SI and menstrual regularity were significantly better with SAXA-MET vs. MET treatment. Triglyceride, triglyceride/high-density lipoprotein cholesterol ratio and mean blood glucose significantly declined in the SAXA-MET and SAXA groups only. This pilot work provides the first evidence regarding the effects of a dipeptidyl peptidase-4 inhibitor alone and in combination with MET in this patient population. Treatment with SAXA-MET was superior to either drug alone in terms of clinical and metabolic benefits in prediabetic patients with PCOS. NCT02022007. Copyright © 2016 American Society for Reproductive Medicine. Published by Elsevier Inc. All rights reserved.

Dendritic Cells Enhance Polyfunctionality of Adoptively Transferred T Cells That Target Cytomegalovirus in Glioblastoma.

PubMed

Reap, Elizabeth A; Suryadevara, Carter M; Batich, Kristen A; Sanchez-Perez, Luis; Archer, Gary E; Schmittling, Robert J; Norberg, Pamela K; Herndon, James E; Healy, Patrick; Congdon, Kendra L; Gedeon, Patrick C; Campbell, Olivia C; Swartz, Adam M; Riccione, Katherine A; Yi, John S; Hossain-Ibrahim, Mohammed K; Saraswathula, Anirudh; Nair, Smita K; Dunn-Pirio, Anastasie M; Broome, Taylor M; Weinhold, Kent J; Desjardins, Annick; Vlahovic, Gordana; McLendon, Roger E; Friedman, Allan H; Friedman, Henry S; Bigner, Darell D; Fecci, Peter E; Mitchell, Duane A; Sampson, John H

2018-01-01

Median survival for glioblastoma (GBM) remains <15 months. Human cytomegalovirus (CMV) antigens have been identified in GBM but not normal brain, providing an unparalleled opportunity to subvert CMV antigens as tumor-specific immunotherapy targets. A recent trial in recurrent GBM patients demonstrated the potential clinical benefit of adoptive T-cell therapy (ATCT) of CMV phosphoprotein 65 (pp65)-specific T cells. However, ex vivo analyses from this study found no change in the capacity of CMV pp65-specific T cells to gain multiple effector functions or polyfunctionality, which has been associated with superior antitumor efficacy. Previous studies have shown that dendritic cells (DC) could further enhance tumor-specific CD8 + T-cell polyfunctionality in vivo when administered as a vaccine. Therefore, we hypothesized that vaccination with CMV pp65 RNA-loaded DCs would enhance the frequency of polyfunctional CMV pp65-specific CD8 + T cells after ATCT. Here, we report prospective results of a pilot trial in which 22 patients with newly diagnosed GBM were initially enrolled, of which 17 patients were randomized to receive CMV pp65-specific T cells with CMV-DC vaccination (CMV-ATCT-DC) or saline (CMV-ATCT-saline). Patients who received CMV-ATCT-DC vaccination experienced a significant increase in the overall frequencies of IFNγ + , TNFα + , and CCL3 + polyfunctional, CMV-specific CD8 + T cells. These increases in polyfunctional CMV-specific CD8 + T cells correlated ( R = 0.7371, P = 0.0369) with overall survival, although we cannot conclude this was causally related. Our data implicate polyfunctional T-cell responses as a potential biomarker for effective antitumor immunotherapy and support a formal assessment of this combination approach in a larger randomized study. Significance: A randomized pilot trial in patients with GBM implicates polyfunctional T-cell responses as a biomarker for effective antitumor immunotherapy. Cancer Res; 78(1); 256-64. ©2017 AACR . ©2017 American Association for Cancer Research.

Comparison of mindfulness-based stress reduction versus yoga on urinary urge incontinence: a randomized pilot study. with 6-month and 1-year follow-up visits.

PubMed

Baker, Jan; Costa, Donna; Guarino, Julie M; Nygaard, Ingrid

2014-01-01

The objective of this study is to compare the effects of mindfulness-based stress reduction (MBSR) versus yoga on urinary urge incontinence (UI) at 8 weeks, 6 months, and 1 year after beginning an 8-week program. Participants in this prospective randomized single-masked pilot study were women aged 18 years or older with urge-predominant incontinence, 5 or more UI episodes (UIEs) on a 3-day voiding diary, and no recent anticholinergic use. Women were randomized to MBSR or yoga. The primary outcome was the percent change of UIE. Of 30 enrollees (15 in MBSR, 15 in yoga), 24 completed at least 5 of 8 sessions (13 in MBSR and 11 in yoga). Twenty and 21 women completed the 6-month and 12-month follow-up visits, respectively. At 8 weeks, 6 months, and 12 months, the median percent change from the baseline in UIE on the intention-to-treat analysis was greater for the MBSR group (-55.6, -71.4, and -66.7, respectively) compared with that for the yoga group (-33.3, -11.8, and -16.7, respectively), with P values ranging from 0.01 to 0.08. On intention-to-treat analysis, the median percent change in the Overactive Bladder Symptom and Quality of Life-Short Form and the Health-Related Quality of Life was greater at each time point for MBSR than for yoga but was statistically significant only at 8 weeks (P = 0.003 and 0.02, respectively). As per protocol analysis, at 8 weeks, 6/13 and 0/11 women in MBSR and yoga, respectively, reported they were very much or much better (P = 0.02), whereas at 1 year, 6/12 and 1/9 women in MBSR and yoga, respectively, did so (P = 0.16). These results support larger scale trials to evaluate MBSR, which seems to be a promising treatment of UI.

A pilot randomized crossover trial assessing the safety and short-term effects of pomegranate supplementation in hemodialysis patients.

PubMed

Rivara, Matthew B; Mehrotra, Rajnish; Linke, Lori; Ruzinski, John; Ikizler, T Alp; Himmelfarb, Jonathan

2015-01-01

Oxidative stress and systemic inflammation are highly prevalent in patients undergoing maintenance hemodialysis (MHD) and are linked to excess cardiovascular risk. This study examined whether short-term supplementation with pomegranate juice and extract is safe and well tolerated by MHD patients. The secondary aim was to assess the effect of pomegranate supplementation on oxidative stress, systemic inflammation, monocyte function, and blood pressure. Prospective, randomized, crossover, pilot clinical trial (NCT01562340). The study was conducted from March to October 2012 in outpatient dialysis facilities in the Seattle metropolitan area. Twenty-four patients undergoing MHD (men, 64%; mean age, 61 ± 14 years) were randomly assigned to receive pomegranate juice or extract during a 4-week intervention period. After a washout period, all patients received the alternative treatment during a second 4-week intervention period. Patients assigned to receive pomegranate juice received 100 mL of juice before each dialysis session. Patients assigned to receive pomegranate extract were given 1,050 mg of extract daily. The main outcome measures were safety and tolerability of pomegranate juice and extract. Additional secondary outcomes assessed included serum lipids, laboratory biomarkers of inflammation (C-reactive protein and interleukin 6) and oxidative stress (plasma F2 isoprostanes and isofurans), monocyte cytokine production, and predialysis blood pressure. Both pomegranate juice and extract were safe and well tolerated by study participants. Over the study period, neither treatment had a significant effect on lipid profiles, plasma C-reactive protein, interleukin 6, F2-isoprostane or isofuran concentrations, predialysis systolic or diastolic blood pressure nor changed the levels of monocyte cytokine production. Both pomegranate juice and extract are safe and well tolerated by patients undergoing MHD but do not influence markers of inflammation or oxidative stress nor affect predialysis blood pressure. Copyright © 2015 National Kidney Foundation, Inc. Published by Elsevier Inc. All rights reserved.

The Coping Cat Program for Children with Anxiety and Autism Spectrum Disorder: A Pilot Randomized Controlled Trial

ERIC Educational Resources Information Center

McNally Keehn, Rebecca H.; Lincoln, Alan J.; Brown, Milton Z.; Chavira, Denise A.

2013-01-01

The purpose of this pilot study was to evaluate whether a modified version of the Coping Cat program could be effective in reducing anxiety in children with autism spectrum disorder (ASD). Twenty-two children (ages 8-14; IQ greater than or equal to 70) with ASD and clinically significant anxiety were randomly assigned to 16 sessions of the Coping…

A Pilot Randomized Controlled Trial of the ACCESS Program: A Group Intervention to Improve Social, Adaptive Functioning, Stress Coping, and Self-Determination Outcomes in Young Adults with Autism Spectrum Disorder

ERIC Educational Resources Information Center

Oswald, Tasha M.; Winder-Patel, Breanna; Ruder, Steven; Xing, Guibo; Stahmer, Aubyn; Solomon, Marjorie

2018-01-01

The purpose of this pilot randomized controlled trial was to investigate the acceptability and efficacy of the Acquiring Career, Coping, Executive control, Social Skills (ACCESS) Program, a group intervention tailored for young adults with autism spectrum disorder (ASD) to enhance critical skills and beliefs that promote adult functioning,…

Kansas Primary Care Weighs In: A Pilot Randomized Trial of a Chronic Care Model Program for Obesity in 3 Rural Kansas Primary Care Practices

ERIC Educational Resources Information Center

Ely, Andrea C.; Banitt, Angela; Befort, Christie; Hou, Qing; Rhode, Paula C.; Grund, Chrysanne; Greiner, Allen; Jeffries, Shawn; Ellerbeck, Edward

2008-01-01

Context: Obesity is a chronic disease of epidemic proportions in the United States. Primary care providers are critical to timely diagnosis and treatment of obesity, and need better tools to deliver effective obesity care. Purpose: To conduct a pilot randomized trial of a chronic care model (CCM) program for obesity care in rural Kansas primary…

Positive end-expiratory pressure during resuscitation at birth in very-low birth weight infants: A randomized-controlled pilot trial.

PubMed

Kitsommart, Ratchada; Nakornchai, Kittaya; Yangthara, Buranee; Jiraprasertwong, Ratchada; Paes, Bosco

2017-12-09

There is limited evidence of the effect of positive end-expiratory pressure (PEEP) during resuscitation soon after birth. Premature neonates may experience respiratory distress from surfactant insufficiency and providing PEEP after the very first breath, may improve outcomes following appropriate resuscitation. The objective of this study was to evaluate the short term respiratory outcomes after positive pressure ventilation (PPV) with PEEP in preterm infants at birth. A prospective randomized-controlled, pilot trial was conducted. Premature neonates ≤ 32 weeks gestational age or birth weight < 1500 g were recruited. Subjects were allocated to either PEEP of 5 cm H 2 O (PEEP-5) or no PEEP (PEEP-0) if PPV was administered. Pre-ductal, peripheral capillary oxygen saturation (SpO 2 ) and fraction of inspired oxygen concentration (FiO 2 ) were monitored at 1, 3, 5, 10, 15, and 20 min after birth. FiO 2 was adjusted to achieve targeted SpO 2 using the 2010 neonatal resuscitation protocol guidelines. 56% (14/25; PEEP-0) and 50% (13/26; PEEP-5) infants received PPV. Mean gestational age was 30 (PEEP-0) vs 31 (PEEP-5) weeks. The mean [SD] birthweight (g) of PEEP-0 was significantly lower than PEEP-5 (1050.4 [262.7] vs 1218.8 [236.8], p = 0.02). Pre-ductal SpO 2, FiO 2 delivered at each time point, and rates of pneumothorax, surfactant administration and oxygen dependency at 36 weeks postmenstrual age or death was similar. Due to the small sample size and potential bias accrued through random allocation of higher birthweight infants to the PEEP-5 group, the results did not confirm differences in outcomes between the groups, despite evidence favoring postnatal ventilation with PEEP. A further randomized, controlled clinical trial with a larger sample size is warranted to determine the utility and safety of PEEP during the resuscitation of premature infants immediately after birth. Copyright © 2017. Published by Elsevier B.V.

Old Habits Die Hard: An Uphill Struggle against Rules without Reason in Mathematics Teacher Education

ERIC Educational Resources Information Center

O'Meara, Niamh; Fitzmaurice, Olivia; Johnson, Patrick

2017-01-01

Mathematics teacher educators in the University of Limerick became aware of a lack of conceptual understanding of key mathematics concepts of prospective secondary mathematics teachers through observation on teaching placement and in pedagogy lectures. A pilot study to enhance the conceptual understanding of prospective teachers was carried out…

Nicotine deprivation and pilot performance during simulated flight.

PubMed

Mumenthaler, Martin S; Benowitz, Neal L; Taylor, Joy L; Friedman, Leah; Noda, Art; Yesavage, Jerome A

2010-07-01

Most airlines enforce no-smoking policies, potentially causing flight performance decrements in pilots who are smokers. We tested the hypotheses that nicotine withdrawal affects aircraft pilot performance within 12 h of smoking cessation and that chewing nicotine gum leads to significant relief of these withdrawal effects. There were 29 pilots, regular smokers, who were tested in a Frasca 141 flight simulator on two 13-h test days, each including three 75-min flights (0 hr, 6 hr, 12 hr) in a randomized, controlled trial. On the first day (baseline), all pilots smoked one cigarette per hour. On the second day, pilots were randomly assigned to one of four groups: (1) nicotine cigarettes; (2) nicotine gum; (3) placebo gum; (4) no cigarettes/no gum. Flight Summary Scores (FSS) were compared between groups with repeated measures ANOVAs. No statistically significant differences in overall simulator flight performance were revealed between pilots who smoked cigarettes and pilots who were not allowed to smoke cigarettes or chew nicotine gum, but there was a trend for pilots who were not allowed to smoke to perform worse. However, pilots who chewed placebo gum performed significantly worse during the 6-h (FSS = -0.03) as well as during the 12-h flight (FSS = -0.08) than pilots who chewed nicotine gum (FSS = 0.15 / 0.30, respectively). Results suggest that nicotine withdrawal effects can impair aircraft pilot performance within 12 h of smoking cessation and that during smoking abstinence chewing one stick of 4-mg nicotine gum per hour may lead to significantly better overall flight performance compared to chewing placebo gum.

Maternal Stress and Young Children's Behavioural Development: A Prospective Pilot Study from 8 to 36 Months in a Finnish Sample

ERIC Educational Resources Information Center

Haapsamo, Helena; Pollock-Wurman, Rachel A.; Kuusikko-Gauffin, Sanna; Ebeling, Hanna; Larinen, Katja; Soini, Hannu; Moilanen, Irma

2013-01-01

The relationship between maternal parenting stress and infant/toddler behavioural development was examined in a longitudinal pilot study. Fifty mothers reported parenting stress via the Parenting Stress Index-Short Form when their infants were eight months old. Parents subsequently rated their children's emotional and behavioural problems with the…

Mindfulness meditation in older adults with postherpetic neuralgia: a randomized controlled pilot study.

PubMed

Meize-Grochowski, Robin; Shuster, George; Boursaw, Blake; DuVal, Michelle; Murray-Krezan, Cristina; Schrader, Ron; Smith, Bruce W; Herman, Carla J; Prasad, Arti

2015-01-01

This parallel-group, randomized controlled pilot study examined daily meditation in a diverse sample of older adults with postherpetic neuralgia. Block randomization was used to allocate participants to a treatment group (n = 13) or control group (n = 14). In addition to usual care, the treatment group practiced daily meditation for six weeks. All participants completed questionnaires at enrollment in the study, two weeks later, and six weeks after that, at the study's end. Participants recorded daily pain and fatigue levels in a diary, and treatment participants also noted meditation practice. Results at the 0.10 level indicated improvement in neuropathic, affective, and total pain scores for the treatment group, whereas affective pain worsened for the control group. Participants were able to adhere to the daily diary and meditation requirements in this feasibility pilot study. Copyright © 2015 Elsevier Inc. All rights reserved.

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.

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.

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.

Effect of omega-3 and vitamin E supplementation on dry mouth in patients with Sjögren's syndrome.

PubMed

Singh, Medha; Stark, Paul C; Palmer, Carole A; Gilbard, Jeffrey P; Papas, Athena S

2010-01-01

To determine whether omega-3 (n-3) increases saliva production in patients with Sjögren's syndrome, 61 patients with Sjögren's received either wheat germ oil (n = 23) or n-3 supplement (TheraTears Nutrition®) (n = 38) in a prospective, randomized, double-masked trial. The outcomes assessed were salivary secretion and markers for oral inflammation. The differences between the n-3 group and wheat germ oil group were not statistically significant for either unstimulated (US) or stimulated (SS) salivary secretion (p= 0.38 and p= 0.346, respectively) nor for the number of sites with probing depth (PD) ≥ 4 mm (p= 0.834). In this pilot study, supplementation with n-3 was not found to be significantly better than wheat germ oil in stimulating saliva production in patients with Sjögren's syndrome. ©2010 Special Care Dentistry Association and Wiley Periodicals, Inc.

Population newborn screening for inherited metabolic disease: current UK perspectives.

PubMed

Green, A; Pollitt, R J

1999-06-01

Some of the generally accepted criteria for screening programmes are inappropriate for newborn metabolic screening as they ignore the family dimension and the importance of timely genetic information. Uncritical application of such criteria creates special difficulties for screening by tandem mass spectrometry, which can detect a range diseases with widely different natural histories and responsiveness to treatment. Further difficulties arise from increasing demands for direct proof of the effects of screening on long-term morbidity and mortality. The randomized controlled trial is held to be the gold standard, but for ethical and practical reasons it will be impossible to achieve for such relatively rare diseases. This approach also oversimplifies the complex matrix of costs and benefits of newborn metabolic screening. A more workable approach could involve Bayesian synthesis, combining quantitative performance data from carefully designed prospective pilot studies of screening with existing experience of the natural history, diagnosis, and management of the individual disorders concerned.

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.

Testing Telephone and Web Surveys for Studying Men's Sexual Assault Perpetration Behaviors

ERIC Educational Resources Information Center

DiNitto, Diana M.; Busch-Armendariz, Noel Bridget; Bender, Kimberly; Woo, Hyeyoung; Tackett-Gibson, Melissa; Dyer, James

2008-01-01

Three pilot studies were conducted to obtain information about sexual assault perpetration from adult men in the United States. Each used the same random digit-dial sampling and recruitment strategy. One pilot was administered by telephone and two via the Web. Response rates in all pilots were low. Although results cannot be generalized beyond the…

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.

Use of a reduced-carbohydrate, modified-fat enteral formula for improving metabolic control and clinical outcomes in long-term care residents with type 2 diabetes: results of a pilot trial.

PubMed

Craig, L D; Nicholson, S; SilVerstone, F A; Kennedy, R D

1998-06-01

Physiologic responses of 30 enterally-fed long-term care residents with type 2 diabetes receiving total nutrition support via either a disease-specific (reduced-carbohydrate, modified-fat) formula or a standard high-carbohydrate formula for 3 mo were compared. Objectives of the study included evaluating metabolic response (glycemic control and lipids) and clinical outcomes. Thirty-four subjects requiring total enteral nutrition support by tube were enrolled in this prospectively randomized, double-blind, controlled, parallel group 3-mo pilot trial. Thirty were evaluable in that they completed 4 wk. Twenty-seven completed all 12 wk. The groups were well-matched for physiologic and demographic parameters at baseline. Fasting serum glucose and capillary (fingerstick) glucose values demonstrated better control in the disease-specific formula-fed group. Serum lipid profiles of this group were similar to or better than those of the standard formula-fed group. The amount of insulin administered to insulin-using subjects in the disease-specific formula-fed group was consistently less than before initiation of the formula, whereas the amount administered was consistently higher in the group fed the standard formula. Overall, subjects randomized to the disease-specific formula experienced better numerical biochemical control and better clinical outcomes when expressed on a numerical and percentage basis. These included surrogate markers of diabetes control such as serum glucose and glycohemoglobin, as well as clinical outcomes such as incidence of infections and pressure ulcers. These findings confirm that the disease-specific formula provides better glycemic control, poses no risk to lipoprotein metabolism, and provides for better clinical outcomes.

Effect of high-frequency repetitive transcranial magnetic stimulation on chronic central pain after mild traumatic brain injury: A pilot study.

PubMed

Choi, Gyu-Sik; Kwak, Sang Gyu; Lee, Han Do; Chang, Min Cheol

2018-02-28

Central pain can occur following traumatic brain injury, leading to poor functional recovery, limitation of activities of daily living, and decreased quality of life. The aim of this study was to determine whether high-frequency (10 Hz) repetitive transcranial magnetic stimulation, applied over the primary motor cortex of the affected hemisphere, can be used to manage chronic central pain after mild traumatic brain injury. Prospective randomized feasibility study. Twelve patients with mild traumatic brain injury and chronic central pain were randomly assigned to transcranial magnetic stimulation (high-frequency stimulation, 10 sessions) or sham groups. Diffuse tensor tractography revealed partially injured spinothalamocortical tracts in all recruited patients. A numerical rating scale (NRS) was used to evaluate pain intensity during pre-treatment and immediately after the 5th transcranial magnetic stimulation session (post1), 10th transcranial magnetic stimulation session (post2), and 1 (post3), 2 (post4), and 4 weeks (post 5) after finishing treatment. Physical and mental health status were evaluated using the Short Form 36 Health Survey (SF-36), including physical and mental component scores (PCS, MCS). The NRS score of the repetitive transcranial magnetic stimulation group was significantly lower than the sham group score at all clinical evaluation time-points during and after transcranial magnetic stimulation sessions. The transcranial magnetic stimulation group's SF-36 PCS score was significantly higher at post2, post3, post4, and post5 compared with the sham group. High-frequency transcranial magnetic stimulation may be used to manage chronic central pain and improve quality of life in patients with mild traumatic brain injury. However, this is a pilot study and further research is needed.

The effect of orofacial myofunctional treatment in children with anterior open bite and tongue dysfunction: a pilot study

PubMed Central

Van Dyck, Claire; Dekeyser, Aline; Vantricht, Elien; Manders, Eric; Goeleven, Ann; Fieuws, Steffen

2016-01-01

Summary Objectives: Insufficient attention is given in the literature to the early treatment of anterior open bite (AOB) subjects receiving orofacial myofunctional therapy (OMT), which aims to harmonize the orofacial functions. This prospective pilot study investigates the effects of OMT on tongue behaviour in children with AOB and a visceral swallowing pattern. Materials and methods: The study comprised of 22 children (11 boys, 11 girls; age range: 7.1–10.6 years). They were randomly assigned into OMT and non-OMT subjects. The randomization was stratified on the presence of a transversal crossbite. At baseline (T0), at the end of treatment (T1) and at 6 months after T1 (T2) maximum tongue elevation strength was measured with the IOPI system (IOPI MEDICAL LLC, Redmond, Washington, USA). Functional characteristics such as tongue posture at rest, swallowing pattern and articulation and the presence of an AOB were observed. Results: OMT did significantly change tongue elevation strength, tongue posture at rest, and tongue position during swallowing of solid food. At T2 more OMT subjects had contact between the lower central incisors and their antagonists or palate (P = 0.036). More OMT subjects performed a physiological pattern of water swallowing than non-OMT children at T1 and T2, although the differences were not significant. Articulation of /s,l,n,d,t/ was not improved by OMT. No interaction between OMT and expansion was found for any of the parameters. Conclusion: OMT can positively influence tongue behaviour. However, further research is recommended to clarify the success of OMT as an adjunct to orthodontic treatment and to identify possible factors influencing the outcome. PMID:26136435

Hypocaloric vs Normocaloric Nutrition in Critically Ill Patients: A Prospective Randomized Pilot Trial.

PubMed

Petros, Sirak; Horbach, Monika; Seidel, Frank; Weidhase, Lorenz

2016-02-01

Optimal nutrition of critically ill patients is still a matter of debate. This pilot trial aimed to compare the impact of normocaloric vs hypocaloric feeding in critically ill patients in the first 7 days in the intensive care unit (ICU). The primary end point was the rate of nosocomial infections during the ICU stay. Critically ill patients requiring artificial nutrition for at least 72 hours were included within 24 hours of ICU admission and randomized into a normocaloric group (receiving 100% of their daily energy expenditure) and a hypocaloric group (receiving 50% of their daily energy expenditure). One hundred patients were included (54 in the normocaloric group and 46 in the hypocaloric group). There were 66 male and 34 female patients with a mean age of 65.8 ± 11.6 years. The mean daily caloric supply was 19.7 ± 5.7 kcal/kg for the normocaloric group and 11.3 ± 3.1 kcal/kg for the hypocaloric group (P = .0001). Insulin demand was significantly higher and gastrointestinal intolerance more frequent in the normocaloric group than in the hypocaloric group. Nosocomial infections were detected more frequently in the hypocaloric group than in the normocaloric group (26.1% vs 11.1%, respectively). The ICU mortality rate was 22.2% in the normocaloric group and 21.7% in the hypocaloric group (not significant). The hospital mortality rate was 31.5% in the normocaloric group and 37.0% in the hypocaloric group (P = .67). Hypocaloric feeding in the first 7 days in critically ill patients was associated with more nosocomial infections but less insulin demand and less gastrointestinal intolerance compared with normocaloric feeding. DRKS00000104 (German Clinical Trials Register). © 2014 American Society for Parenteral and Enteral Nutrition.

Effects of omega-3 fatty acids on arterial stiffness in patients with hypertension: a randomized pilot study.

PubMed

Krantz, Mori J; Havranek, Edward P; Pereira, Rocio I; Beaty, Brenda; Mehler, Philip S; Long, Carlin S

2015-12-02

Omega-3 fatty acids prevent cardiovascular disease (CVD) events in patients with myocardial infarction or heart failure. Benefits in patients without overt CVD have not been demonstrated, though most studies did not use treatment doses (3.36 g) of omega-3 fatty acids. Arterial stiffness measured by pulse wave velocity (PWV) predicts CVD events independent of standard risk factors. However, no therapy has been shown to reduce PWV in a blood pressure-independent manner. We assessed the effects of esterified omega-3 fatty acids on PWV and serum markers of inflammation among patients with hypertension. We performed a prospective, randomized; double-blinded pilot study of omega-3 fatty acids among 62 patients in an urban, safety net hospital. Patients received 3.36 g of omega-3 fatty acids vs. matched placebo daily for 3-months. The principal outcome measure was change in brachial-ankle PWV. Serum inflammatory markers associated with CVD risk were also assessed. The majority (71 %) were of Latino ethnicity. After 3-months, mean change in arterial PWV among omega-3 and placebo groups was -97 cm/s vs. -33 cm/s respectively (p = 0.36 for difference, after multivariate adjustment for baseline age, systolic blood pressure, and serum adiponectin). Non-significant reductions in lipoprotein-associated phospholipase A2 (LpPLA2) mass and high sensitivity C-reactive protein (hsCRP) relative to placebo were also observed (p = 0.08, and 0.21, respectively). High-dose omega-3 fatty acids did not reduce arterial PWV or markers of inflammation among patients within a Latino-predominant population with hypertension. NCT00935766 , registered July 8 2009.

Chronic migraine headache prevention with noninvasive vagus nerve stimulation: The EVENT study.

PubMed

Silberstein, Stephen D; Calhoun, Anne H; Lipton, Richard B; Grosberg, Brian M; Cady, Roger K; Dorlas, Stefanie; Simmons, Kristy A; Mullin, Chris; Liebler, Eric J; Goadsby, Peter J; Saper, Joel R

2016-08-02

To evaluate the feasibility, safety, and tolerability of noninvasive vagus nerve stimulation (nVNS) for the prevention of chronic migraine (CM) attacks. In this first prospective, multicenter, double-blind, sham-controlled pilot study of nVNS in CM prophylaxis, adults with CM (≥15 headache d/mo) entered the baseline phase (1 month) and were subsequently randomized to nVNS or sham treatment (2 months) before receiving open-label nVNS treatment (6 months). The primary endpoints were safety and tolerability. Efficacy endpoints in the intent-to-treat population included change in the number of headache days per 28 days and acute medication use. Fifty-nine participants (mean age, 39.2 years; mean headache frequency, 21.5 d/mo) were enrolled. During the randomized phase, tolerability was similar for nVNS (n = 30) and sham treatment (n = 29). Most adverse events were mild/moderate and transient. Mean changes in the number of headache days were -1.4 (nVNS) and -0.2 (sham) (Δ = 1.2; p = 0.56). Twenty-seven participants completed the open-label phase. For the 15 completers initially assigned to nVNS, the mean change from baseline in headache days after 8 months of treatment was -7.9 (95% confidence interval -11.9 to -3.8; p < 0.01). Therapy with nVNS was well-tolerated with no safety issues. Persistent prophylactic use may reduce the number of headache days in CM; larger sham-controlled studies are needed. NCT01667250. This study provides Class II evidence that for patients with CM, nVNS is safe, is well-tolerated, and did not significantly change the number of headache days. This pilot study lacked the precision to exclude important safety issues or benefits of nVNS. © 2016 American Academy of Neurology.

A prospective randomized controlled trial comparing occupational therapy with home-based exercises in conservative treatment of rotator cuff tears.

PubMed

Krischak, Gert; Gebhard, Florian; Reichel, Heiko; Friemert, Benedikt; Schneider, Florian; Fisser, Christoph; Kaluscha, Rainer; Kraus, Michael

2013-09-01

This pilot study evaluates the outcome after occupational therapy, compared to home-based exercises in the conservative treatment of patients with full thickness rotator cuff tears. Forty-three adult subjects (range, 18-75 years), who had a full thickness rupture of the rotator cuff which was verified by magnetic imaging tomography, with clinical signs of a chronic rotator cuff impingement, and who were available for follow-up, were randomized to occupational therapy or to independent home-based exercises using a booklet. After drop-out, 38 patients were available for full examination at follow-up. Before therapy and after 2 months of conservative treatment, pain intensity, the Constant-Murley score, isokinetic strength testing in abduction and external rotation, functional limitation, clinical shoulder tests and health-related quality of life (EQ-5D) were evaluated. Two-thirds of the patients improved in clinical shoulder tests, regardless of the therapy group. There were no significant differences between the groups with reference to pain, range of motion, maximum peak force (abduction, external rotation), the Constant-Murley score, and the EQ-5D index. The only significant difference observed was the improvement in the self-assessed health- related quality of life (EQ-5D VAS) favoring home-based exercises. Home-based exercise, on the basis of an illustrated booklet with exercises twice a day, supplies comparable results to formal occupational therapy in the conservative treatment of rotator cuff tears. The results of this pilot study suggest some potential advantages related to psychological benefits using home-based treatment. Copyright © 2013 Journal of Shoulder and Elbow Surgery Board of Trustees. Published by Mosby, Inc. All rights reserved.

The HAPI 'Hip Arthroscopy Pre-habilitation Intervention' study: does pre-habilitation affect outcomes in patients undergoing hip arthroscopy for femoro-acetabular impingement?

PubMed

Grant, Louise F; Cooper, Derek J; Conroy, Jon L

2017-01-01

The purpose of this randomized prospective comparative controlled pilot study was to determine whether specific patient exercises done pre-hip arthroscopy surgery for femoro-acetabular impingement affected post-operative recovery. Between October 2013 and June 2014, 6 males and twelve females over the age of eighteen, who were listed for hip arthroscopy for femoro-acetabular impingement, were randomized into two groups. A hip-specific, 8-week home exercise programme was given to the experimental group before their surgery. The control group was given no instruction on exercise before surgery. All participants followed the same rehabilitation programme after surgery. Outcome measures were assessed at set time intervals. Hand held dynamometry was used to assess muscle strength, and the EQ-5D-5 L Score and the Non-Arthritic Hip Score were utilized. Sixteen participants completed the study (eight controls: mean age 41.75 years and eight intervention: mean age 37.5 years). A mixed ANCOVA analysis compared the treatment groups taking baseline values into account. A statistically significant difference was found between the treatment groups for knee extension strength on both operative ( P  = 0.05) and non-operative sides ( P  = 0.002), hip flexor strength operative side ( P  = 0.02) and for EQ-5D-5 L health ( P  = 0.03), in favour of the intervention group. There was no significant difference between the treatment groups for the other measures, although some tended towards significance. This small pilot study has been designed to aid the further research and the differences between the groups found in these results may inform future larger scale studies.

Does teaching crisis resource management skills improve resuscitation performance in pediatric residents?*.

PubMed

Blackwood, Jaime; Duff, Jonathan P; Nettel-Aguirre, Alberto; Djogovic, Dennis; Joynt, Chloe

2014-05-01

The effect of teaching crisis resource management skills on the resuscitation performance of pediatric residents is unknown. The primary objective of this pilot study was to determine if teaching crisis resource management to residents leads to improved clinical and crisis resource management performance in simulated pediatric resuscitation scenarios. A prospective, randomized control pilot study. Simulation facility at tertiary pediatric hospital. Junior pediatric residents. Junior pediatric residents were randomized to 1 hour of crisis resource management instruction or no additional training. Time to predetermined resuscitation tasks was noted in simulated resuscitation scenarios immediately after intervention and again 3 months post intervention. Crisis resource management skills were evaluated using the Ottawa Global Rating Scale. Fifteen junior residents participated in the study, of which seven in the intervention group. The intervention crisis resource management group placed monitor leads 24.6 seconds earlier (p = 0.02), placed an IV 47.1 seconds sooner (p = 0.04), called for help 50.4 seconds faster (p = 0.03), and checked for a pulse after noticing a rhythm change 84.9 seconds quicker (p = 0.01). There was no statistically significant difference in time to initiation of cardiopulmonary resuscitation (p = 0.264). The intervention group had overall crisis resource management performance scores 1.15 points higher (Ottawa Global Rating Scale [out of 7]) (p = 0.02). Three months later, these differences between the groups persisted. A 1-hour crisis resource management teaching session improved time to critical initial steps of pediatric resuscitation and crisis resource management performance as measured by the Ottawa Global Rating Scale. The control group did not develop these crisis resource management skills over 3 months of standard training indicating that obtaining these skills requires specific education. Larger studies of crisis resource education are required.

Pilot study evaluating the effect of massage therapy on stress, anxiety and aggression in a young adult psychiatric inpatient unit.

PubMed

Garner, Belinda; Phillips, Lisa J; Schmidt, Hans-Martin; Markulev, Connie; O'Connor, Jenny; Wood, Stephen J; Berger, Gregor E; Burnett, Peter; McGorry, Patrick D

2008-05-01

The aim of the present pilot study was to examine the effectiveness of a relaxation massage therapy programme in reducing stress, anxiety and aggression on a young adult psychiatric inpatient unit. This was a prospective, non-randomized intervention study comparing treatment as usual (TAU) with TAU plus massage therapy intervention (MT) over consecutive 7 week blocks (May-August 2006). MT consisted of a 20 min massage therapy session offered daily to patients during their period of hospitalization. The Kennedy Nurses' Observational Scale for Inpatient Evaluation (NOSIE), the Symptom Checklist-90-Revised (SCL-90-R), the State-Trait Anxiety Inventory (STAI) and stress hormone (saliva cortisol) levels were used to measure patient outcomes at admission and discharge from the unit. The Staff Observation Aggression Scale-Revised (SOAS-R) was used to monitor the frequency and severity of aggressive incidents on the unit. There was a significant reduction in self-reported anxiety (p < 0.001), resting heart rate (p < 0.05) and cortisol levels (p < 0.05) immediately following the initial and final massage therapy sessions. Significant improvements in hostility (p = 0.007) and depression scores (p < 0.001) on the SCL-90-R were observed in both treatment groups. There was no group x time interaction on any of the measures. Poor reliability of staff-reported incidents on the SOAS-R limited the validity of results in this domain. Massage therapy had immediate beneficial effects on anxiety-related measures and may be a useful de-escalating tool for reducing stress and anxiety in acutely hospitalized psychiatric patients. Study limitations preclude any definite conclusions on the effect of massage therapy on aggressive incidents in an acute psychiatric setting. Randomized controlled trials are warranted.

The HAPI ‘Hip Arthroscopy Pre-habilitation Intervention’ study: does pre-habilitation affect outcomes in patients undergoing hip arthroscopy for femoro-acetabular impingement?

PubMed Central

Cooper, Derek J.; Conroy, Jon L.

2017-01-01

Abstract The purpose of this randomized prospective comparative controlled pilot study was to determine whether specific patient exercises done pre-hip arthroscopy surgery for femoro-acetabular impingement affected post-operative recovery. Between October 2013 and June 2014, 6 males and twelve females over the age of eighteen, who were listed for hip arthroscopy for femoro-acetabular impingement, were randomized into two groups. A hip-specific, 8-week home exercise programme was given to the experimental group before their surgery. The control group was given no instruction on exercise before surgery. All participants followed the same rehabilitation programme after surgery. Outcome measures were assessed at set time intervals. Hand held dynamometry was used to assess muscle strength, and the EQ-5D-5 L Score and the Non-Arthritic Hip Score were utilized. Sixteen participants completed the study (eight controls: mean age 41.75 years and eight intervention: mean age 37.5 years). A mixed ANCOVA analysis compared the treatment groups taking baseline values into account. A statistically significant difference was found between the treatment groups for knee extension strength on both operative (P = 0.05) and non-operative sides (P = 0.002), hip flexor strength operative side (P = 0.02) and for EQ-5D-5 L health (P = 0.03), in favour of the intervention group. There was no significant difference between the treatment groups for the other measures, although some tended towards significance. This small pilot study has been designed to aid the further research and the differences between the groups found in these results may inform future larger scale studies. PMID:28630726

A Pilot Study of the Challenges and Prospects of Continuous Assessment Implementation in Nigeria

ERIC Educational Resources Information Center

Owolabi, Henry O.; Onuka, Adams O. U.

2010-01-01

This study obtained basic information from teachers and students on the challenges and prospects of implementing continuous assessment (CA) in the Nigerian school system. Secondary Schools in Ilorin, the capital city of Kwara State, located in the central region of Nigeria were sampled for use in the study. It employed survey research design…

The Role of Character in the Hiring Process: A Pilot Study Survey of College Seniors' Potential Employers

ERIC Educational Resources Information Center

Firmin, Michael; Proemmel, Elizabeth; McDivitt, Sarah; Evens, Jennifer; Gibbs, Lew

2009-01-01

We surveyed 31 prospective employers (65% response rate) regarding their views on character as part of the employment selection process. The results showed character qualities superordinate, relative to skills that prospective employees bring to potential jobs. We discuss survey results in light of business educators' responsibility for helping…

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.

Effect of vertical active vibration isolation on tracking performance and on ride qualities

NASA Technical Reports Server (NTRS)

Dimasi, F. P.; Allen, R. E.; Calcaterra, P. C.

1972-01-01

An investigation to determine the effect on pilot performance and comfort of an active vibration isolation system for a commercial transport pilot seat is reported. The test setup consisted of: a hydraulic shaker which produced random vertical vibration inputs; the active vibration isolation system; the pilot seat; the pilot control wheel and column; the side-arm controller; and a two-axis compensatory tracking task. The effects of various degrees of pilot isolation on short-term (two-minute) tracking performance and comfort were determined.

Effects of whole-body vibration on plasma sclerostin level in healthy women.

PubMed

Çidem, Muharrem; Karakoç, Yunus; Ekmekçi, Hakan; Küçük, Suat Hayri; Uludağ, Murat; Gün, Kerem; Karamehmetoğlu, Safak Sahir; Karacan, İlhan

2014-01-01

To determine whether plasma sclerostin levels are affected by applying whole-body vibration treatments. Following a pilot study, the pretsent prospective, randomized, controlled single-blind study was performed on 16 healthy volunteer women (ages 20 to 40 years). Subjects were randomly divided into 2 groups, and whole-body vibration was applied to the treatment group but not to the controls. The plasma sclerostin levels were measured before the treatment and at the 10th minute after whole-body vibration on the 1st, 2nd, and 5th days of application. The plasma sclerostin level measured at 10 min after the whole-body vibration treatment increased 91% (P = 0.024) on the 1st day and decreased 31.5% (P = 0.03) on the 5th day in the whole-body vibration group. In the control group, there was no change in the plasma sclerostin level at any time. A progressive increase in baseline plasma sclerostin levels during the 5 days of vibration sessions was also found. Our study demonstrated that whole-body vibration can change plasma sclerostin levels, and that this change is detectable 10 min after whole-body vibration treatments.

Superficial dermabrasion versus topical tretinoin on early striae distensae: a randomized, pilot study.

PubMed

Hexsel, Doris; Soirefmann, Mariana; Porto, Manoela D; Schilling-Souza, Juliana; Siega, Carolina; Dal'Forno, Taciana

2014-05-01

Striae distensae (SD) is a common skin condition, with a prevalence ranging from 40% to 90%, depending on the population studied. To evaluate the efficacy of superficial dermabrasion and compare it with that of topical tretinoin cream in the treatment of narrow and early SD. Prospective, single-center, randomized, open-label study. Thirty-two women presenting with early, untreated SD (striae rubra) were included in this study. One group received 16 weekly sessions of superficial and localized dermabrasion, and the other used 0.05% tretinoin cream daily. Striae width and length were measured and compared between groups and over time. Global Aesthetic Improvement Scale scores and subject satisfaction were also assessed. Biopsies were performed for subjects who agreed to undergo this procedure, followed by histologic analyses of the skin samples. Both treatments were efficacious, with significant improvement in early SD from baseline, but there was no significant difference between the two treatments. Histologic assessment showed improvement in epidermal and dermal layers for the dermabrasion treatment group. Both treatments had similar efficacy, but superficial dermabrasion had a lower frequency of side effects and better adherence of the patients. © 2014 by the American Society for Dermatologic Surgery, Inc. Published by Wiley Periodicals, Inc.

Comparison of visual evoked potential monitoring during spine surgeries under total intravenous anesthesia versus balanced general anesthesia.

PubMed

Uribe, Alberto A; Mendel, Ehud; Peters, Zoe A; Shneker, Bassel F; Abdel-Rasoul, Mahmoud; Bergese, Sergio D

2017-10-01

To determine the comparison of its clinical utility and safety profile for visual evoked potential (VEP) monitoring during prone spine surgeries under total intravenous anesthesia (TIVA) versus balanced general anesthesia using the SightSaver™ visual stimulator. The protocol was designed asa pilot, single center, prospective, randomized, and double-arm study. Subjects were randomized to receive either TIVA or balanced general anesthesia. Following induction and intubation, 8 electrodes were placed subcutaneously to collect VEP recordings. The SightSaver™ visual stimulator was placed on the subject's scalp before prone positioning. VEP waveforms were recorded every 30min and assessed by a neurophysiologist throughout the length of surgery. A total of 19 subjects were evaluated and VEP waveforms were successfully collected. TIVA group showed higher amplitude and lower latency than balanced anesthesia. Our data suggested that TIVA is associated with higher VEP amplitude and shorter latencies than balanced general anesthesia; therefore, TIVA could be the most efficient anesthesia regimen for VEP monitoring. The findings help to better understand the effect of different anesthesia regimens on intra-operative VEP monitoring. Copyright © 2017 International Federation of Clinical Neurophysiology. Published by Elsevier B.V. All rights reserved.

No effect of preoperative selective gut decontamination on endotoxemia and cytokine activation during cardiopulmonary bypass: a randomized, placebo-controlled study.

PubMed

Bouter, Hens; Schippers, Emile F; Luelmo, Saskia A C; Versteegh, Michael I M; Ros, Peter; Guiot, Henri F L; Frölich, Marijke; van Dissel, Jaap T

2002-01-01

Cardiopulmonary bypass predisposes the splanchnic region to inadequate perfusion and increases in gut permeability. Related to these changes, circulating endotoxin has been shown to rise during cardiac surgery, and may contribute to cytokine activation, high oxygen consumption, and fever ("postperfusion syndrome"). To a large extent, free endotoxin in the gut is a product of the proliferation of aerobic gram-negative bacteria and may be reduced by nonabsorbable antibiotics. To evaluate the effect of preoperative selective gut decontamination (SGD) on the incidence of endotoxemia and cytokine activation in patients undergoing open heart surgery. Prospective, randomized, placebo-controlled double-blind trial. Tertiary-care university teaching hospital. Preoperative administration for 5 to 7 days of oral nonabsorbable antibiotics (polymyxin B and neomycin) vs. placebo. The efficacy of SGD was assessed by culture of rectal swabs. Forty-four patients (median age 65 yrs, 29 males) were included in a pilot study to establish the sampling points of perioperative measurements. Seventy-eight consecutive patients (median age 65 yrs, 55 males) were enrolled for the prospective study; of these, 51 were randomly allocated to take SGD (n = 24) or placebo (n = 27); 27 were included in a control group (no medication). SGD but not placebo effectively reduced the number of rectal swabs that grew aerobic gram-negative bacteria (27% vs. 93%, respectively; p < .001). SGD did not affect the occurrence of perioperative endotoxemia, nor did it reduce the tumor necrosis factor-alpha, interleukin-10, or interleukin-6 concentrations (p > .20), as determined before surgery, upon aorta declamping, 30 mins into reperfusion, or 2 hrs after surgery. Also, SGD did not alter the incidence of postoperative fever or clinical outcome measures such as duration of artificial ventilation and intensive care unit and hospital stay. SGD effectively reduces the aerobic gram-negative bowel flora in cardiac surgery patients but fails to affect the incidence of perioperative endotoxemia and cytokine activation during cardiopulmonary bypass and the occurrence of a postperfusion syndrome.

The rehabilitation of attention in patients with mild cognitive impairment and brain subcortical vascular changes using the Attention Process Training-II. The RehAtt Study: rationale, design and methodology.

PubMed

Salvadori, Emilia; Poggesi, Anna; Valenti, Raffaella; Della Rocca, Eleonora; Diciotti, Stefano; Mascalchi, Mario; Inzitari, Domenico; Pantoni, Leonardo

2016-10-01

Cerebral small vessel disease (SVD) may cause attentional and executive cognitive deficits. No drug is currently available to improve cognitive performance or to prevent dementia in SVD patients, and cognitive rehabilitation could be a promising approach. We aimed to investigate: (1) the effectiveness of the Attention Process Training-II program in the rehabilitation of patients with mild cognitive impairment (MCI) and SVD; (2) the impact of the induced cognitive improvement on functionality and quality of life; (3) the effect of training on brain activity at rest and the possibility of a training-induced plasticity effect. The RehAtt study is designed as a 3-year prospective, single-blinded, randomized clinical trial. Inclusion criteria were: (1) MCI defined according to Winblad et al. criteria; (2) evidence of impairment across attention neuropsychological tests; (3) evidence on MRI of moderate/severe white matter hyperintensities. All enrolled patients are evaluated at baseline, and after 6 and 12 months, according to an extensive clinical, functional, MRI and neuropsychological protocol. The baseline RehAtt cohort includes 44 patients (66 % males, mean ± SD age and years of education 75.3 ± 6.8 and 8.3 ± 4.3, respectively). After baseline assessment, patients have been randomly assigned to 'attention training' or 'standard care'. Treatments and follow-up visits at 6 months are completed, while follow-up visits at 12 months are ongoing. This study is the first attempt to reduce attention deficits in patients affected by MCI with SVD. The results of this pilot experience will represent an essential background for designing larger multicenter, prospective, double-blinded, randomized and controlled clinical trials. NCT02033850 (ClinicalTrials.gov Identifier).

Patent foramen ovale and asymptomatic brain lesions in military fighter pilots.

PubMed

Kang, Kyung Wook; Kim, Joon-Tae; Choi, Won-Ho; Park, Won-Ju; Shin, Young Ho; Choi, Kang-Ho

2014-10-01

Previous studies have reported higher incidence of white matter lesions (WMLs) in military pilots. The anti-gravity straining maneuver, which fighter military pilots perform numerously during a flight is identical to the valsalva maneuver. We sought to investigate the prevalence of right-to-left shunt (RLS) associated with WMLs in military pilots. A prospective study was performed involving military pilots who visited the Airomedical Center. The pilots underwent brain magnetic resonance imaging (MRI) scan and transcranial Doppler (TCD) with intravenous injection of agitated saline solution for the detection of RLS. Periventricular WMLs (PVWMLs) on MRI were graded using Fazeka's scale, and deep WMLs (DWMLs) were graded using Scheltens's scale. This study included 81 military pilots. RLS on TCD was observed less frequently in non-fighter pilots than in fighter pilots (35.5% vs. 64.5%, p=0.011). Fighter pilot was an independently associated factor with RLS on the TCD. DWMLs were independently associated with RLSs through a patent foramen ovale (PFO) (OR 3.507, 95% CI 1.223-10.055, p=0.02). The results suggest that DWMLs in military pilots may significantly be associated with RLS via PFO. Additional investigations are warranted. Copyright © 2014 Elsevier B.V. All rights reserved.

Instrumental delivery of the fetal head at the time of elective repeat cesarean: a randomized pilot study.

PubMed

Bofill, J A; Lencki, S G; Barhan, S; Ezenagu, L C

2000-01-01

We sought to ascertain whether the routine use of instruments, forceps or vacuum, at the time of elective repeat cesarean delivery, permits a delivery that is as safe for mother and infant and as easy for mother and physician as traditional manual delivery of the fetal head. In this prospective study 44 women undergoing elective repeat cesarean were randomized to deliver by Vacuum (V), Forceps (F), or by Manual (M) means. Groups were compared with regard to demographic variables and maternal and neonatal outcomes. Deliveries were timed from entry into the uterus until full delivery of the infant. Maternal pain scores were assessed using a 10-cm visual analog scale. There were no differences in demographic variables except that the M group had fewer women with up to two cesareans. A large percentage of women in each group were delivered with the randomized instrument. Use of the V did not demonstrate fewer extensions of the uterine incision or lesser amounts of blood loss as measured by serial hemoglobin determinations. There was a trend for the F group to require a longer period of time for delivery (p = 0.061). Women in the V group reported significantly lower pain scores (p = 0.015). There were no serious neonatal injuries. The routine use of instruments at the time of elective repeat cesarean delivery appears safe and effective.

Risk reduction of brain infarction during carotid endarterectomy or stenting using sonolysis - Prospective randomized study pilot data

NASA Astrophysics Data System (ADS)

Kuliha, Martin; Školoudík, David; Martin Roubec, Martin; Herzig, Roman; Procházka, Václav; Jonszta, Tomáš; Krajča, Jan; Czerný, Dan; Hrbáč, Tomáš; Otáhal, David; Langová, Kateřina

2012-11-01

Sonolysis is a new therapeutic option for the acceleration of arterial recanalization. The aim of this study was to confirm risk reduction of brain infarction during endarterectomy (CEA) and stenting (CAS) of the internal carotid artery (ICA) using sonolysis with continuous transcranial Doppler (TCD) monitoring by diagnostic 2 MHz probe, additional interest was to assess impact of new brain ischemic lesions on cognitive functions. Methods: All consecutive patients 1/ with ICA stenosis >70%, 2/ indicated to CEA or CAS, 3/ with signed informed consent, were enrolled to the prospective study during 17 months. Patients were randomized into 2 groups: Group 1 with sonolysis during intervention and Group 2 without sonolysis. Neurological examination, assessment of cognitive functions and brain magnetic resonance imaging (MRI) were performed before and 24 hours after intervention in all patients. Occurrence of new brain infarctions (including infarctions >0.5 cm3), and the results of Mini-Mental State Examination, Clock Drawing and Verbal Fluency tests were statistically evaluated using T-test. Results: 97 patients were included into the study. Out of the 47 patients randomized to sonolysis group (Group 1) 25 underwent CEA (Group 1a) and 22 CAS (Group 1b). Out of the 50 patients randomized to control group (Group 2), 22 underwent CEA (Group 2a) and 28 CAS (Group 2b). New ischemic brain infarctions on follow up MRI were found in 14 (29.8%) patients in Group 1-4 (16.0%) in Group 1a and 10 (45.5%) in Group 1b. In Group 2, new ischemic brain infarctions were found in 18 (36.0%) patients-6 (27.3%) in Group 2a and 12 (42.9%) in Group 2b (p>0.05 in all cases). New ischemic brain infarctions >0.5 cm3 were found in 4 (8.5 %) patients in Group 1 and in 11 (22.0 %) patients in Group 2 (p= 0.017). No significant differences were found in cognitive tests results between subgroups (p>0.05 in all tests). Conclusion: Sonolysis seems to be effective in the prevention of large ischemic brain infarctions during CEA and CAS.

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.

Impact of implementation of a novel antimicrobial stewardship tool on antibiotic use in nursing homes: a prospective cluster randomized control pilot study.

PubMed

Fleet, Elizabeth; Gopal Rao, G; Patel, Bharat; Cookson, Barry; Charlett, Andre; Bowman, Clive; Davey, Peter

2014-08-01

To evaluate the impact of 'Resident Antimicrobial Management Plan' (RAMP), a novel antimicrobial stewardship tool on systemic antibiotic use for treatment of infection in nursing homes (NHs). A pilot cluster randomized control study was conducted in 30 NHs in London. Pre-intervention, we collected point prevalence data on antimicrobial use on three occasions and total antimicrobial consumption for a 12 week period. Post-intervention data were collected in the same manner and included assessment of compliance with RAMP in the intervention group (IG). The number of residents included was 1628 pre-intervention [825 IG/803 control group (CG)] and 1610 post-intervention (838 IG/772 CG). The corresponding pre- and post-intervention point prevalence of systemic antibiotic prescribing for treatment of infection was 6.46% and 6.52% in the IG [estimated prevalence ratio: 1.01 (95% CI: 0.81-1.25), P = 0.94] compared with 5.27% and 5.83%, respectively, in the CG [estimated prevalence ratio: 1.11 (95% CI: 0.87-1.41), P = 0.4]. Total antibiotic consumption was 69.78 defined daily doses/1000 residents/day (DRD) pre-intervention and 66.53 DRD post-intervention in the IG compared with 49.68 and 51.92 DRD, respectively, in the CG. There was a significant decrease of 4.9% (3.25 DRD) in the IG (95% CI: 1.0%-8.6%) (P = 0.02) compared with a significant increase of 5.1% (2.24 DRD) in the CG (95% CI: 0.2%-10.2%) (P = 0.04). Main indications for antibiotics were lower respiratory tract infections (34.1%), urinary tract infections (28.5%) and skin/soft tissue infections (25.1%). This pilot study demonstrated that use of RAMP was associated with a statistically significant decrease in total antibiotic consumption and has the potential to be an important antimicrobial stewardship tool for NHs. © The Author 2014. Published by Oxford University Press on behalf of the British Society for Antimicrobial Chemotherapy. All rights reserved. For Permissions, please e-mail: journals.permissions@oup.com.

A clinical carepath for obese pregnant women: A pragmatic pilot cluster randomized controlled trial.

PubMed

McDonald, Sarah D; Viaje, Kristen A; Rooney, Rebecca A; Jarde, Alexander; Giglia, Lucia; Maxwell, Cynthia V; Small, David; Kelly, Tracy Pearce; Midwifery, B H Sc; Sabatino, Lisa; Thabane, Lehana

2018-05-17

Obese women are at increased risks for complications during pregnancy, birth and in their infants. Although guidelines have been established for the clinical care of obese pregnant women, management is sometimes suboptimal. Our goal was to determine the feasibility of implementing and testing a clinical carepath for obese pregnant women compared to standard care, in a pilot cluster randomized controlled trial (RCT). A pragmatic pilot cluster RCT was conducted, randomly allocating eight clinics to the carepath or standard care for obese pregnant women. Women were eligible if they had a prepregnancy body mass index of ≥ 30 kg/m 2 and a viable singleton < 21 weeks. The primary outcomes were the feasibility of conducting a full-scale cluster RCT (defined as > 80%: randomization of clinics, use in eligible women, and completeness of follow-up) and of the intervention (defined as > 80%: compliance with each step in the carepath, and recommendation of the carepath by clinicians to a colleague). All eight approached clinics agreed to participate and were randomized. Half of the intervention clinics used the carepath, resulting in < 80% uptake of eligible women. High follow-up (99.5%) was achieved, in 188 of 189 women. The carepath was feasible for numerous guideline-directed recommendations for screening, but less so for counselling topics. When the carepath was used in the majority of women, all clinicians, most of whom were midwives, reported they would recommend it to a colleague. The intervention group had significantly higher overall adherence to the guideline recommendations compared to control (relative risk 1.71, 95% confidence interval 1.57-1.87). In this pragmatic pilot cluster RCT, a guideline-directed clinical carepath improved some aspects of care of obese pregnant women and was recommended by clinicians, particularly midwives. A cluster RCT may not be feasible in a mix of obstetric and midwifery clinics, but may be feasible in midwifery clinics. This pragmatic pilot cluster RCT was registered on clinicaltrials.gov (identifier: NCT02534051 ).

General aviation pilot and aircraft activity survey

DOT National Transportation Integrated Search

1983-12-01

This report provides a summary and analysis of the data collected : in the 1981 General Aviation Pilot and Aircraft Activity Survey. : The survey was conducted at a random sample of airports across the : nation throughout the months of July, August, ...

General aviation pilot and aircraft activity survey.

DOT National Transportation Integrated Search

1983-12-01

This report provides a summary and analysis of the data collected : in the 1981 General Aviation Pilot and Aircraft Activity Survey. : The survey was conducted at a random sample of airports across the : nation throughout the months of July, August, ...

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.

Comparison of organochlorine chemical body burdens of female breast cancer cases with cancer free women in Rio Grande do Sul, Brazil--Pilot Study

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

Erdmann, C.A.; Petreas, M.X.; Caleffi, M.

This pilot study collected preliminary data to examine known and suspected breast cancer risk factors among women living in rural and urban areas in the state of Rio Grande do Sul, Brazil by questionnaire. In addition, the body burden levels of a panel of organochlorines was measured in a small clinic-based prospective sample.

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…

An internal pilot design for prospective cancer screening trials with unknown disease prevalence.

PubMed

Brinton, John T; Ringham, Brandy M; Glueck, Deborah H

2015-10-13

For studies that compare the diagnostic accuracy of two screening tests, the sample size depends on the prevalence of disease in the study population, and on the variance of the outcome. Both parameters may be unknown during the design stage, which makes finding an accurate sample size difficult. To solve this problem, we propose adapting an internal pilot design. In this adapted design, researchers will accrue some percentage of the planned sample size, then estimate both the disease prevalence and the variances of the screening tests. The updated estimates of the disease prevalence and variance are used to conduct a more accurate power and sample size calculation. We demonstrate that in large samples, the adapted internal pilot design produces no Type I inflation. For small samples (N less than 50), we introduce a novel adjustment of the critical value to control the Type I error rate. We apply the method to two proposed prospective cancer screening studies: 1) a small oral cancer screening study in individuals with Fanconi anemia and 2) a large oral cancer screening trial. Conducting an internal pilot study without adjusting the critical value can cause Type I error rate inflation in small samples, but not in large samples. An internal pilot approach usually achieves goal power and, for most studies with sample size greater than 50, requires no Type I error correction. Further, we have provided a flexible and accurate approach to bound Type I error below a goal level for studies with small sample size.

General aviation pilot and aircraft activity survey

DOT National Transportation Integrated Search

1979-12-01

This report provides a summary and analysis of the data collected : 1n the 1978 General Aviation Pilot and Aircraft Activity Survey. The : survey Has conducted at a random sample of airports across the nation : and Puerto Rico, throughout the months ...

General aviation pilot and aircraft activity survey.

DOT National Transportation Integrated Search

1985-09-01

This report provides a summary and analysis of the data collected in the 1984 General Aviation Pilot and Aircraft Activity Survey. The survey was conducted at a random sample of airports across the nation throughout the months of July, August, and Se...

Topical Allium ampeloprasum subsp Iranicum (Leek) extract cream in patients with symptomatic hemorrhoids: a pilot randomized and controlled clinical trial.

PubMed

Mosavat, Seyed Hamdollah; Ghahramani, Leila; Sobhani, Zahra; Haghighi, Ehsan Rahmanian; Heydari, Mojtaba

2015-04-01

Allium ampeloprasum subsp iranicum (Leek) has been traditionally used in antihemorrhoidal topical herbal formulations. This study aimed to evaluate its safety and efficacy in a pilot randomized controlled clinical trial. Twenty patients with symptomatic hemorrhoids were randomly allocated to receive the topical leek extract cream or standard antihemorrhoid cream for 3 weeks. The patients were evaluated before and after the intervention in terms of pain, defecation discomfort, bleeding severity, anal itching severity, and reported adverse events. A significant decrease was observed in the grade of bleeding severity and defecation discomfort in both the leek and antihemorrhoid cream groups after the intervention, while no significant change was observed in pain scores. There was no significant difference between the leek and antihemorrhoid cream groups with regard to mean changes in outcome measures. This pilot study showed that the topical use of leek cream can be as effective as a standard antihemorrhoid cream. © The Author(s) 2015.

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.

Combination of Vancomycin and β-Lactam Therapy for Methicillin-Resistant Staphylococcus aureus Bacteremia: A Pilot Multicenter Randomized Controlled Trial.

PubMed

Davis, Joshua S; Sud, Archana; O'Sullivan, Matthew V N; Robinson, James O; Ferguson, Patricia E; Foo, Hong; van Hal, Sebastiaan J; Ralph, Anna P; Howden, Benjamin P; Binks, Paula M; Kirby, Adrienne; Tong, Steven Y C; Tong, Steven; Davis, Joshua; Binks, Paula; Majumdar, Suman; Ralph, Anna; Baird, Rob; Gordon, Claire; Jeremiah, Cameron; Leung, Grace; Brischetto, Anna; Crowe, Amy; Dakh, Farshid; Whykes, Kelly; Kirkwood, Maria; Sud, Archana; Menon, Mahesh; Somerville, Lucy; Subedi, Shrada; Owen, Shirley; O'Sullivan, Matthew; Liu, Eunice; Zhou, Fei; Robinson, Owen; Coombs, Geoffrey; Ferguson, Patrician; Ralph, Anna; Liu, Eunice; Pollet, Simon; Van Hal, Sebastian; Foo, Hong; Van Hal, Sebastian; Davis, Rebecca

2016-01-15

In vitro laboratory and animal studies demonstrate a synergistic role for the combination of vancomycin and antistaphylococcal β-lactams for methicillin-resistant Staphylococcus aureus (MRSA) bacteremia. Prospective clinical data are lacking. In this open-label, multicenter, clinical trial, adults with MRSA bacteremia received vancomycin 1.5 g intravenously twice daily and were randomly assigned (1:1) to receive intravenous flucloxacillin 2 g every 6 hours for 7 days (combination group) or no additional therapy (standard therapy group). Participants were stratified by hospital and randomized in permuted blocks of variable size. Randomization codes were kept in sealed, sequentially numbered, opaque envelopes. The primary outcome was the duration of MRSA bacteremia in days. We randomly assigned 60 patients to receive vancomycin (n = 29), or vancomycin plus flucloxacillin (n = 31). The mean duration of bacteremia was 3.00 days in the standard therapy group and 1.94 days in the combination group. According to a negative binomial model, the mean time to resolution of bacteremia in the combination group was 65% (95% confidence interval, 41%-102%; P = .06) that in the standard therapy group. There was no difference in the secondary end points of 28- and 90-day mortality, metastatic infection, nephrotoxicity, or hepatotoxicity. Combining an antistaphylococcal β-lactam with vancomycin may shorten the duration of MRSA bacteremia. Further trials with a larger sample size and objective clinically relevant end points are warranted. Australian New Zealand Clinical Trials Registry: ACTRN12610000940077 (www.anzctr.org.au). © The Author 2015. Published by Oxford University Press for the Infectious Diseases Society of America. All rights reserved. For permissions, e-mail journals.permissions@oup.com.

Randomized trial of standard pain control with or without gabapentin for pain related to radiation-induced mucositis in head and neck cancer.

PubMed

Kataoka, Tomoko; Kiyota, Naomi; Shimada, Takanobu; Funakoshi, Yohei; Chayahara, Naoko; Toyoda, Masanori; Fujiwara, Yutaka; Nibu, Ken-Ichi; Komori, Takahide; Sasaki, Ryohei; Mukohara, Toru; Minami, Hironobu

2016-12-01

Radiation-induced mucositis (RIM) in chemoradiotherapy (CRT) for head and neck cancer (HNC) causes severe pain and worsens CRT compliance, QOL and outcome. Following retrospective reports, we conducted a randomized trial of the safety and efficacy of gabapentin for RIM-associated pain during CRT. HNC patients (pts) receiving CRT were randomized to standard pain control (SPC) with acetaminophen and opioids, or SPC plus gabapentin (SPC+G). Gabapentin was maintained at 900mg/day for 4 weeks after CRT. Primary endpoint was maximum visual analogue scale (VAS) score during CRT, and secondary endpoints were total opioid dose, changes in QOL (EORTC QLQ-C30 and QLQ-HN 35) from baseline to 4 weeks after CRT, and adverse events. Twenty-two eligible Stage III or IV pts were randomly assigned to SPC or SPC+G (n=11 each). Twelve were treated in a locally advanced setting and 10 in a postoperative setting. Median maximum VAS scores, median total dose of opioids at maximum VAS and total dose of opioids at 4 weeks after CRT tended to be higher in the SPC+G arm (47 in SPC vs. 74 in SPC+G, p=0.517; 215mg vs. 745.3mg, p=0.880; and 1260mg vs. 1537.5mg, p=0.9438, respectively), without significance. QOL analysis showed significantly worse scores in the SPC+G arm for weight gain (p=0.005). Adverse events related to gabapentin were manageable. This pilot study is the first prospective randomized trial of gabapentin for RIM-related pain. Gabapentin had no apparent beneficial effect. Further research into agents for RIM-related pain is warranted. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

A randomized prospective pilot trial of Web-delivered epilepsy stigma reduction communications in young adults.

PubMed

Sajatovic, Martha; Herrmann, Lynn K; Van Doren, Jamie R; Tatsuoka, Curtis; Welter, Elisabeth; Perzynski, Adam T; Bukach, Ashley; Needham, Kelley; Liu, Hongyan; Berg, Anne T

2017-11-01

Epilepsy is a common neurological condition that is often associated with stigmatizing attitudes and negative stereotypes among the general public. This randomized controlled trial (RCT) tested two new communication approaches targeting epilepsy stigma versus an education-alone approach. Two brief stigma-reduction videos were developed, informed by community stakeholder input; one highlighted role competency in people with epilepsy; the other highlighted social inclusion of people with epilepsy. A control video was also developed. A Web-based survey using a prospective RCT design compared effects of experimental videos and control on acceptability, perceived impact, epilepsy knowledge, and epilepsy stigma. Epilepsy knowledge and stigma were measured with the Epilepsy Knowledge Questionnaire (EKQ) and Attitudes and Beliefs about Living with Epilepsy (ABLE), respectively. A total of 295 participants completed the study. Mean age was 23.1 (standard deviation = 3.27) years; 59.0% were male, and 71.4% were white. Overall, respondents felt videos impacted their epilepsy attitudes. EKQ scores were similar across videos, with a trend for higher knowledge in experimental videos versus control (p = 0.06). The role competency and control videos were associated with slightly better perceived impact on attitudes. There were no differences between videos on ABLE scores (p = 0.568). There were subgroup differences suggesting that men, younger individuals, whites, and those with personal epilepsy experience had more stigmatizing attitudes. This RCT tested communication strategies to improve knowledge and attitudes about epilepsy. Although this initial effort will require follow-up, we have demonstrated the acceptability, feasibility, and potential of novel communication strategies to target epilepsy stigma, and a Web-based approach for assessing them. Wiley Periodicals, Inc. © 2017 International League Against Epilepsy.

Covariance Matrix Estimation for Massive MIMO

NASA Astrophysics Data System (ADS)

Upadhya, Karthik; Vorobyov, Sergiy A.

2018-04-01

We propose a novel pilot structure for covariance matrix estimation in massive multiple-input multiple-output (MIMO) systems in which each user transmits two pilot sequences, with the second pilot sequence multiplied by a random phase-shift. The covariance matrix of a particular user is obtained by computing the sample cross-correlation of the channel estimates obtained from the two pilot sequences. This approach relaxes the requirement that all the users transmit their uplink pilots over the same set of symbols. We derive expressions for the achievable rate and the mean-squared error of the covariance matrix estimate when the proposed method is used with staggered pilots. The performance of the proposed method is compared with existing methods through simulations.

Meditation for migraines: a pilot randomized controlled trial.

PubMed

Wells, Rebecca Erwin; Burch, Rebecca; Paulsen, Randall H; Wayne, Peter M; Houle, Timothy T; Loder, Elizabeth

2014-10-01

Our objective was to assess the safety, feasibility, and effects of the standardized 8-week mindfulness-based stress reduction (MBSR) course in adults with migraines. Stress is a well-known trigger for headaches. Research supports the general benefits of mind/body interventions for migraines, but there are few rigorous studies supporting the use of specific standardized interventions. MBSR is a standardized 8-week mind/body intervention that teaches mindfulness meditation/yoga. Preliminary research has shown MBSR to be effective for chronic pain syndromes, but it has not been evaluated for migraines. We conducted a randomized controlled trial with 19 episodic migraineurs randomized to either MBSR (n = 10) or usual care (n = 9). Our primary outcome was change in migraine frequency from baseline to initial follow-up. Secondary outcomes included change in headache severity, duration, self-efficacy, perceived stress, migraine-related disability/impact, anxiety, depression, mindfulness, and quality of life from baseline to initial follow-up. MBSR was safe (no adverse events), with 0% dropout and excellent adherence (daily meditation average: 34 ± 11 minutes, range 16-50 minutes/day). Median class attendance from 9 classes (including retreat day) was 8 (range [3, 9]); average class attendance was 6.7 ± 2.5. MBSR participants had 1.4 fewer migraines/month (MBSR: 3.5 to 1.0 vs control: 1.2 to 0 migraines/month, 95% confidence interval CI [-4.6, 1.8], P = .38), an effect that did not reach statistical significance in this pilot sample. Headaches were less severe, although not significantly so (-1.3 points/headache on 0-10 scale, [-2.3, 0.09], P = .053) and shorter (-2.9 hours/headache, [-4.6, -0.02], P = .043) vs control. Migraine Disability Assessment and Headache Impact Test-6 dropped in MBSR vs control (-12.6, [-22.0, -1.0], P = .017 and -4.8, [-11.0, -1.0], P = .043, respectively). Self-efficacy and mindfulness improved in MBSR vs control (13.2 [1.0, 30.0], P = .035 and 13.1 [3.0, 26.0], P = .035 respectively). MBSR is safe and feasible for adults with migraines. Although the small sample size of this pilot trial did not provide power to detect statistically significant changes in migraine frequency or severity, secondary outcomes demonstrated this intervention had a beneficial effect on headache duration, disability, self-efficacy, and mindfulness. Future studies with larger sample sizes are warranted to further evaluate this intervention for adults with migraines. This study was prospectively registered (ClinicalTrials.gov identifier NCT01545466). © 2014 American Headache Society.

General Aviation Pilot and Aircraft Activity Survey : 1978

DOT National Transportation Integrated Search

1979-12-01

This report provides a summary and analysis of the data collected in the 1978 General Aviation Pilot and Aircraft Activity Survey. The survey was conducted at a random sample of airports across the nation and Puerto Rico, throughout the months of Jul...

Efficacy of Wii-Fit on Static and Dynamic Balance in Community Dwelling Older Veterans: A Randomized Controlled Pilot Trial

PubMed Central

Dubbert, Patricia M.

2017-01-01

Background/Objectives. Balance problems are well-established modifiable risk factors for falls, which are common in older adults. The objective of this study was to establish the efficacy of a Wii-Fit interactive video-game-led physical exercise program to improve balance in older Veterans. Methods. A prospective randomized controlled parallel-group trial was conducted at Veterans Affairs Medical Center. Thirty community dwelling Veterans aged 68 (±6.7) years were randomized to either the exercise or control groups. The exercise group performed Wii-Fit program while the control group performed a computer-based cognitive program for 45 minutes, three days per week for 8-weeks. The primary (Berg Balance Scale (BBS)) and secondary outcomes (fear of falling, physical activity enjoyment, and quality of life) were measured at baseline, 4 weeks, and 8 weeks. Results. Of 30 randomized subjects, 27 completed all aspects of the study protocol. There were no study-related adverse events. Intent-to-treat analysis showed a significantly greater improvement in BBS in the exercise group (6.0; 95% CI, 5.1–6.9) compared to the control group (0.5; 95% CI, −0.3–1.3) at 8 weeks (average intergroup difference (95% CI), 5.5 (4.3–6.7), p < 0.001) after adjusting for baseline. Conclusion. This study establishes that the Wii-Fit exercise program is efficacious in improving balance in community dwelling older Veterans. This trial is registered with ClinicalTrials.gov Identifier NCT02190045. PMID:28261500

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.

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 randomized controlled trial comparing prenatal yoga to perinatal health education for antenatal depression.

PubMed

Uebelacker, Lisa A; Battle, Cynthia L; Sutton, Kaeli A; Magee, Susanna R; Miller, Ivan W

2016-06-01

We conducted a pilot randomized controlled trial (RCT) comparing a prenatal yoga intervention to perinatal-focused health education in pregnant women with depression. Findings document acceptability and feasibility of the yoga intervention: no yoga-related injuries were observed, instructors showed fidelity to the yoga manual, and women rated interventions as acceptable. Although improvements in depression were not statistically different between groups, they favored yoga. This study provides support for a larger scale RCT examining prenatal yoga to improve mood during pregnancy.

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.

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.

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

Dietary Effects on Cognition and Pilots' Flight Performance.

PubMed

Lindseth, Glenda N; Lindseth, Paul D; Jensen, Warren C; Petros, Thomas V; Helland, Brian D; Fossum, Debra L

2011-01-01

The purpose of this study was to investigate the effects of diet on cognition and flight performance of 45 pilots. Based on a theory of self-care, this clinical study used a repeated-measure, counterbalanced crossover design. Pilots were randomly rotated through 4-day high-carbohydrate, high-protein, high-fat, and control diets. Cognitive flight performance was evaluated using a GAT-2 full-motion flight simulator. The Sternberg short-term memory test and Vandenberg's mental rotation test were used to validate cognitive flight test results. Pilots consuming a high-protein diet had significantly poorer ( p < .05) overall flight performance scores than pilots consuming high-fat and high-carbohydrate diets.

Creative music therapy to promote brain structure, function, and neurobehavioral outcomes in preterm infants: a randomized controlled pilot trial protocol.

PubMed

Haslbeck, Friederike Barbara; Bucher, Hans-Ulrich; Bassler, Dirk; Hagmann, Cornelia

2017-01-01

Preterm birth is associated with increased risk of neurological impairment and deficits in cognition, motor function, and behavioral problems. Limited studies indicate that multi-sensory experiences support brain development in preterm infants. Music appears to promote neurobiological processes and neuronal learning in the human brain. Creative music therapy (CMT) is an individualized, interactive therapeutic approach based on the theory and methods of Nordoff and Robbins. CMT may promote brain development in preterm infants via concurrent interaction and meaningful auditory stimulation. We hypothesize that preterm infants who receive creative music therapy during neonatal intensive care admission will have developmental benefits short- and long-term brain function. A prospective, randomized controlled single-center pilot trial involving 60 clinically stable preterm infants under 32 weeks of gestational age is conducted in preparation for a multi-center trial. Thirty infants each are randomized to either standard neonatal intensive care or standard care with CMT. Music therapy intervention is approximately 20 min in duration three times per week. A trained music therapist sings for the infants in lullaby style, individually entrained and adjusted to the infant's rhythm and affect. Primary objectives of this study are feasibility of protocol implementation and investigating the potential mechanism of efficacy for this new intervention. To examine the effect of this new intervention, non-invasive, quantitative magnetic resonance imaging (MRI) methods at corrected age and standardized neurodevelopmental assessments using the Bayley Scales of Infant and Toddler Development third edition at a corrected age of 24 months and Kaufman Assessment Battery for Children at 5 years will be performed. All assessments will be performed and analyzed by blinded experts. To our knowledge, this is the first randomized controlled clinical trial to systematically examine possible effects of creative music therapy on short- and long-term brain development in preterm infants. This project lies at the interface of music therapy, neuroscience, and medical imaging. New insights into the potential role and impact of music on brain function and development may be elucidated. If such a low-cost, low-risk intervention is demonstrated in a future multi-center trial to be effective in supporting brain development in preterm neonates, findings could have broad clinical implications for this vulnerable patient population. ClinicalTrials.gov, NCT02434224.

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.

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/

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.

Pilot pharmacologic randomized controlled trial for psychogenic nonepileptic seizures(e–Pub ahead of print)(LOE Classification)

PubMed Central

LaFrance, W.C.; Keitner, G.I.; Papandonatos, G.D.; Blum, A.S.; Machan, J.T.; Ryan, C.E.; Miller, I.W.

2010-01-01

Objective: There have been few treatment trials for psychogenic nonepileptic seizures (PNES). Some psychotherapies have been shown to improve PNES and comorbid symptom outcomes. We evaluated a pharmacologic intervention to test the hypothesis that sertraline would reduce PNES. Methods: We conducted a pilot, double-blind, randomized, placebo-controlled trial in an academic medical hospital with epilepsy center outpatients. Subjects aged 18 to 65 years diagnosed with video-EEG–confirmed PNES were treated with flexible-dose sertraline or placebo over 12 weeks. Seizure calendars and symptom scales were charted prospectively. Secondary outcome measures included psychiatric symptom scales and psychosocial variables. Results: Thirty-eight subjects enrolled, and 26 (68%) completed the trial. Thirty-three subjects with nonzero nonepileptic seizure rates at baseline were included in intent-to-treat analysis of the primary outcome. Subjects assigned to the sertraline arm experienced a 45% reduction in seizure rates from baseline to final visit (p = 0.03) vs an 8% increase in placebo (p = 0.78). Secondary outcome scales revealed no significant between-group differences in change scores from baseline to final visit, after adjustment for differences at baseline. Conclusions: PNES were reduced in patients treated with a serotonin selective reuptake inhibitor, whereas those treated with placebo slightly increased. This study provides feasibility data for a larger-scale study. Level of evidence: This study provides Class II evidence that flexible-dose sertraline up to a maximum dose of 200 mg is associated with a nonsignificant reduction in PNES rate compared with a placebo control arm (risk ratio 0.51, 95% confidence interval 0.25–1.05, p = 0.29), adjusting for differences at baseline. GLOSSARY AED = antiepileptic drug; CI = confidence interval; DSM-IV = Diagnostic and Statistical Manual of Mental Disorders, 4th edition; ES = epileptic seizures; ITT = intent to treat; PNES = psychogenic nonepileptic seizures; PTSD = posttraumatic stress disorder; QOL = quality of life; RCT = randomized controlled trial; RIH = Rhode Island Hospital; RR = risk ratio; SSRI = serotonin selective reuptake inhibitor; vEEG = video-EEG. PMID:20739647

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.

Nitrous oxide for pain management of first trimester surgical abortion -- a randomized controlled pilot study.

PubMed

Singh, Rameet H; Espey, Eve; Carr, Shannon; Pereda, Brenda; Ogburn, Tony; Leeman, Lawrence

2015-02-01

The objective was to determine feasibility of a study comparing mean pain scores between women randomized to nitrous oxide/oxygen (NO) versus oxygen+oral analgesics for trimester surgical abortion. Pilot randomized controlled trial comparing NO (n=10) versus oxygen+oral analgesics (n=10). Feasibility of subject recruitment, and pain and satisfaction scores on a visual analog scale were evaluated. Fifty-seven percent of eligible women participated. Mean pain scores were similar between groups, and mean satisfaction scores were higher for the NO group (77.5 vs. 46.7, P=.048). The majority of eligible women agreed to participate in this study evaluating an uncommon pain control intervention. Copyright © 2015 Elsevier Inc. All rights reserved.

Effect of chiropractic manipulation on vertical jump height in young female athletes with talocrural joint dysfunction: a single-blind randomized clinical pilot trial.

PubMed

Hedlund, Sofia; Nilsson, Hans; Lenz, Markus; Sundberg, Tobias

2014-02-01

The main objective of this pilot study was to explore the effect of chiropractic high-velocity, low-amplitude (HVLA) manipulation on vertical jump height in young female athletes with talocrural joint dysfunction. This was a randomized assessor-blind clinical pilot trial. Twenty-two female handball players with talocrural joint dysfunction were randomized to receive either HVLA manipulation (n = 11) or sham treatment (n = 11) once a week during a 3-week period. The main outcome was change in vertical jump height from baseline to follow-up within and between groups after 3 weeks. Nineteen athletes completed the study. After 3 weeks, the group receiving HVLA manipulation (n = 11) had a statistically significant mean (SD) improvement in vertical jump height of 1.07 (1.23) cm (P = .017). The sham treatment group (n = 8) improved their vertical jump height by 0.59 (2.03) cm (P = .436). The between groups' change was 0.47 cm (95% confidence interval, -1.31 to 2.26; P = .571) in favor of the group receiving HVLA manipulation. Blinding and sham procedures were feasible, and there were no reported adverse events. The results of this pilot study show that a larger-scale study is feasible. Preliminary results suggest that chiropractic HVLA manipulation may increase vertical jump height in young female athletes with talocrural joint dysfunction. However, the clinical result in favor of HVLA manipulation compared with sham treatment needs statistical confirmation in a larger randomized clinical trial. Copyright © 2014 National University of Health Sciences. Published by Mosby, Inc. All rights reserved.

Pilot randomized controlled trial of dialectical behavior therapy group skills training for ADHD among college students.

PubMed

Fleming, Andrew P; McMahon, Robert J; Moran, Lyndsey R; Peterson, A Paige; Dreessen, Anthony

2015-03-01

ADHD affects between 2% and 8% of college students and is associated with broad functional impairment. No prior randomized controlled trials with this population have been published. The present study is a pilot randomized controlled trial evaluating dialectical behavior therapy (DBT) group skills training adapted for college students with ADHD. Thirty-three undergraduates with ADHD between ages 18 and 24 were randomized to receive either DBT group skills training or skills handouts during an 8-week intervention phase. ADHD symptoms, executive functioning (EF), and related outcomes were assessed at baseline, post-treatment, and 3-month follow-up. Participants receiving DBT group skills training showed greater treatment response rates (59-65% vs. 19-25%) and clinical recovery rates (53-59% vs. 6-13%) on ADHD symptoms and EF, and greater improvements in quality of life. DBT group skills training may be efficacious, acceptable, and feasible for treating ADHD among college students. A larger randomized trial is needed for further evaluation. © 2014 SAGE Publications.

Cryopreserved amniotic membrane for modulation of periodontal soft tissue healing: a pilot study.

PubMed

Velez, Ines; Parker, William B; Siegel, Michael A; Hernandez, Maria

2010-12-01

The purpose of this randomized study is to evaluate cryopreserved amniotic membrane (CAM) for helping cicatrization and wound healing after dental implant surgery. Epithelialization, pain, infection, inflammation, and scarring were studied. CAM was placed in surgical wounds related to implant surgery. The extent of healing was evaluated by a masked investigator for lesion size, epithelialization, pain, infection, inflammation, and scarring. A clinical evaluation occurred at baseline, 72 and 144 hours, 2 weeks, and 1, 1.5, and 3 months. The results were compared to conventionally managed, similar lesions that were treated the same day in the same patient allowing each patient to serve as their own control. This prospective randomized study showed statistically significant differences between experimental and control groups regarding cicatrization, wound healing, and pain. The effects of the membrane were statistically significant during the first 3 weeks of the study, and thereafter, the effects of the membrane for the two groups were equivalent. CAM was effective in helping cicatrization and wound healing. CAM supported the growth of the epithelium and, thus, facilitated migration and reinforced adhesion. It also decreased the pain of subjects. Regarding dental implants, the use of CAM is not cost effective. New studies evaluating other oral conditions are encouraged.

Q-Switched 660-nm Versus 532-nm Nd: YAG Laser for the Treatment for Facial Lentigines in Asian Patients: A Prospective, Randomized, Double-Blinded, Split-Face Comparison Pilot Study.

PubMed

Noh, Tai Kyung; Chung, Bo Young; Yeo, Un Cheol; Chang, SeoYoun; Lee, Mi Woo; Chang, Sung Eun

2015-12-01

Q-switched (QS) 532-nm lasers are widely used to treat solar lentigines. To compare the efficacy and safety of 660-nm and 532-nm QS neodymium-doped yttrium aluminum garnet (Nd:YAG) lasers in the treatment for lentigines in Asians. The halves of each face (randomly chosen) of 8 Korean Fitzpatrick Skin Type III-IV women with facial solar lentigines were treated with either 660-nm or 532-nm lasers. Pigmentation was measured objectively using a profilometric skin analysis tool and subjectively using the pigmentation area and severity index (PSI) score, global assessment of the aesthetic improvement scale (GAIS), and a patient satisfaction score at Weeks 4 and 8. Seven patients completed the study. No significant differences were found in the PSI, GAIS, patient satisfaction score, and melanin average score between the lasers. The melanin average level was significantly reduced by the 660-nm laser but not the 532-nm laser at Week 8 compared with the baseline. Both 660-nm and 532-nm QS Nd:YAG lasers effectively reduce pigmentation for up to 8 weeks with high patient satisfaction. The new 660-nm laser therefore increases the treatment options for lentigines in Asian skin.

Collegiate Aviation Review. September 1993.

ERIC Educational Resources Information Center

Barker, Ballard M., Ed.

This document contains two papers on aviation education. "Chief Pilots of Regional Airlines Perceive Basic Instrument Skills as Most Important with Respect to Need for Additional Training of Entry-Level Pilots" (William C. Herrick) reports the results of a study in which 126 (of a population of 197) randomly selected regional airlines' chief…

ENabling Reduction of Low-grade Inflammation in SEniors Pilot Study: Concept, Rationale, and Design.

PubMed

Manini, Todd M; Anton, Stephen D; Beavers, Daniel P; Cauley, Jane A; Espeland, Mark A; Fielding, Roger A; Kritchevsky, Stephen B; Leeuwenburgh, Christiaan; Lewis, Kristina H; Liu, Christine; McDermott, Mary M; Miller, Michael E; Tracy, Russell P; Walston, Jeremy D; Radziszewska, Barbara; Lu, Jane; Stowe, Cindy; Wu, Samuel; Newman, Anne B; Ambrosius, Walter T; Pahor, Marco

2017-09-01

To test two interventions to reduce interleukin (IL)-6 levels, an indicator of low-grade chronic inflammation and an independent risk factor for impaired mobility and slow walking speed in older adults. The ENabling Reduction of low-Grade Inflammation in SEniors (ENRGISE) Pilot Study was a multicenter, double-blind, placebo-controlled randomized pilot trial of two interventions to reduce IL-6 levels. Five university-based research centers. Target enrollment was 300 men and women aged 70 and older with an average plasma IL-6 level between 2.5 and 30 pg/mL measured twice at least 1 week apart. Participants had low to moderate physical function, defined as self-reported difficulty walking one-quarter of a mile or climbing a flight of stairs and usual walk speed of less than 1 m/s on a 4-m usual-pace walk. Participants were randomized to losartan, omega-3 fish oil (ω-3), combined losartan and ω-3, or placebo. Randomization was stratified depending on eligibility for each group. A titration schedule was implemented to reach a dose that was safe and effective for IL-6 reduction. Maximal doses were 100 mg/d for losartan and 2.8 g/d for ω-3. IL-6, walking speed over 400 m, physical function (Short Physical Performance Battery), other inflammatory markers, safety, tolerability, frailty domains, and maximal leg strength were measured. Results from the ENRGISE Pilot Study will provide recruitment yields, feasibility, medication tolerance and adherence, and preliminary data to help justify a sample size for a more definitive randomized trial. The ENRGISE Pilot Study will inform a larger subsequent trial that is expected to have important clinical and public health implications for the growing population of older adults with low-grade chronic inflammation and mobility limitations. © 2017, Copyright the Authors Journal compilation © 2017, The American Geriatrics Society.

Pre-consultation educational group intervention to improve shared decision-making in postmastectomy breast reconstruction: study protocol for a pilot randomized controlled trial.

PubMed

Platt, Jennica; Baxter, Nancy; Jones, Jennifer; Metcalfe, Kelly; Causarano, Natalie; Hofer, Stefan O P; O'Neill, Anne; Cheng, Terry; Starenkyj, Elizabeth; Zhong, Toni

2013-07-06

The Pre-Consultation Educational Group INTERVENTION pilot study seeks to assess the feasibility and inform the optimal design for a definitive randomized controlled trial that aims to improve the quality of decision-making in postmastectomy breast reconstruction patients. This is a mixed-methods pilot feasibility randomized controlled trial that will follow a single-center, 1:1 allocation, two-arm parallel group superiority design. The University Health Network, a tertiary care cancer center in Toronto, Canada. Adult women referred to one of three plastic and reconstructive surgeons for delayed breast reconstruction or prophylactic mastectomy with immediate breast reconstruction. We designed a multi-disciplinary educational group workshop that incorporates the key components of shared decision-making, decision-support, and psychosocial support for cancer survivors prior to the initial surgical consult. The intervention consists of didactic lectures by a plastic surgeon and nurse specialist on breast reconstruction choices, pre- and postoperative care; a value-clarification exercise led by a social worker; and discussions with a breast reconstruction patient. Usual care includes access to an informational booklet, website, and patient volunteer if desired. Expected pilot outcomes include feasibility, recruitment, and retention targets. Acceptability of intervention and full trial outcomes will be established through qualitative interviews. Trial outcomes will include decision-quality measures, patient-reported outcomes, and service outcomes, and the treatment effect estimate and variability will be used to inform the sample size calculation for a full trial. Our pilot study seeks to identify the (1) feasibility, acceptability, and design of a definitive RCT and (2) the optimal content and delivery of our proposed educational group intervention. Thirty patients have been recruited to date (8 April 2013), of whom 15 have been randomized to one of three decision support workshops. The trial will close as planned in May 2013. NCT01857882.

Randomized Controlled Pilot Trial of Mindfulness Training for Stress Reduction during Pregnancy

PubMed Central

Guardino, Christine M.; Dunkel Schetter, Christine; Bower, Julienne E.; Lu, Michael C.; Smalley, Susan L.

2014-01-01

This randomized controlled pilot trial tested a 6-week mindfulness-based intervention in a sample of pregnant women experiencing high levels of perceived stress and pregnancy anxiety. Forty-seven women enrolled between 10 and 25 weeks gestation were randomly assigned to either a series of weekly Mindful Awareness Practices (MAPS) classes (n = 24) with home practice or to a reading control condition (n = 23). Hierarchical linear models of between-group differences in change over time demonstrated that participants in the mindfulness intervention experienced larger decreases from pre-to post-intervention in pregnancy-specific anxiety and pregnancy-related anxiety than participants in the reading control condition. However, these effects were not sustained through follow-up at six weeks post-intervention. Participants in both groups experienced increased mindfulness, as well as decreased perceived stress and state anxiety over the course of the intervention and follow-up periods. This study is one of the first randomized controlled pilot trials of a mindfulness meditation intervention during pregnancy and provides some evidence that mindfulness training during pregnancy may effectively reduce pregnancy-related anxiety and worry. We discuss some of the dilemmas in pursuing this translational strategy and offer suggestions for researchers interested in conducting mind-body interventions during pregnancy. PMID:24180264

Metacognitive therapy versus cognitive behavioural therapy for depression: a randomized pilot study.

PubMed

Jordan, Jennifer; Carter, Janet D; McIntosh, Virginia V W; Fernando, Kumari; Frampton, Christopher M A; Porter, Richard J; Mulder, Roger T; Lacey, Cameron; Joyce, Peter R

2014-10-01

Metacognitive therapy (MCT) is one of the newer developments within cognitive therapy. This randomized controlled pilot study compared independently applied MCT with cognitive behavioural therapy (CBT) in outpatients with depression to explore the relative speed and efficacy of MCT, ahead of a planned randomized controlled trial. A total of 48 participants referred for outpatient therapy were randomized to up to 12 weeks of MCT or CBT. Key outcomes were reduction in depressive symptoms at week 4 and week 12, measured using the independent-clinician-rated Quick Inventory of Depressive Symptomatology16. Intention-to-treat and completer analyses as well as additional methods of reporting outcome of depression are presented. Both therapies were effective in producing clinically significant change in depressive symptoms, with moderate-to-large effect sizes obtained. No differences were detected between therapies in overall outcome or early change on clinician-rated or self-reported measures. Post-hoc analyses suggest that MCT may have been adversely affected by greater comorbidity. In this large pilot study conducted independently of MCT's developers, MCT was an effective treatment for outpatients with depression, with similar results overall to CBT. Insufficient power and imbalanced comorbidity limit conclusions regarding comparative efficacy so further studies of MCT and CBT are required. © The Royal Australian and New Zealand College of Psychiatrists 2014.

Using Electronic Health Records to Enhance a Peer Health Navigator Intervention: A Randomized Pilot Test for Individuals with Serious Mental Illness and Housing Instability.

PubMed

Kelly, Erin L; Braslow, Joel T; Brekke, John S

2018-05-03

Individuals with serious mental illnesses have high rates of comorbid physical health issues and have numerous barriers to addressing their health and health care needs. The present pilot study tested the feasibility of a modified form of the "Bridge" peer-health navigator intervention delivered in a usual care setting by agency personnel. The modifications concerned the use of an electronic personal health record with individuals experiencing with housing instability. Twenty participants were randomized to receive the intervention immediately or after 6 months. Health navigator contacts and use of personal health records were associated with improvements in health care and self-management. This pilot study demonstrated promising evidence for the feasibility of adding personal health record use to a peer-led intervention.

Design and methods for a pilot randomized clinical trial involving exercise and behavioral activation to treat comorbid type 2 diabetes and major depressive disorder

PubMed Central

Schneider, Kristin L.; Pagoto, Sherry L.; Handschin, Barbara; Panza, Emily; Bakke, Susan; Liu, Qin; Blendea, Mihaela; Ockene, Ira S.; Ma, Yunsheng

2011-01-01

Background The comorbidity of type 2 diabetes mellitus (T2DM) and depression is associated with poor glycemic control. Exercise has been shown to improve mood and glycemic control, but individuals with comorbid T2DM and depression are disproportionately sedentary compared to the general population and report more difficulty with exercise. Behavioral activation, an evidence-based depression psychotherapy, was designed to help people with depression make gradual behavior changes, and may be helpful to build exercise adherence in sedentary populations. This pilot randomized clinical trial will test the feasibility of a group exercise program enhanced with behavioral activation strategies among women with comorbid T2DM and depression. Methods/Design Sedentary women with inadequately controlled T2DM and depression (N=60) will be randomly assigned to one of two conditions: exercise or usual care. Participants randomized to the exercise condition will attend 38 behavioral activation-enhanced group exercise classes over 24 weeks in addition to usual care. Participants randomized to the usual care condition will receive depression treatment referrals and print information on diabetes management via diet and physical activity. Assessments will occur at baseline and 3-, 6-, and 9-months following randomization. The goals of this pilot study are to demonstrate feasibility and intervention acceptability, estimate the resources and costs required to deliver the intervention and to estimate the standard deviation of continuous outcomes (e.g., depressive symptoms and glycosylated hemoglobin) in preparation for a fully-powered randomized clinical trial. Discussion A novel intervention that combines exercise and behavioral activation strategies could potentially improve glycemic control and mood in women with comorbid type 2 diabetes and depression. Trial registration NCT01024790 PMID:21765864

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

PubMed

Christison, Amy; Khan, Huma Ali

2012-04-01

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

A model-based analysis of a display for helicopter landing approach. [control theoretical model of human pilot

NASA Technical Reports Server (NTRS)

Hess, R. A.; Wheat, L. W.

1975-01-01

A control theoretic model of the human pilot was used to analyze a baseline electronic cockpit display in a helicopter landing approach task. The head down display was created on a stroke written cathode ray tube and the vehicle was a UH-1H helicopter. The landing approach task consisted of maintaining prescribed groundspeed and glideslope in the presence of random vertical and horizontal turbulence. The pilot model was also used to generate and evaluate display quickening laws designed to improve pilot vehicle performance. A simple fixed base simulation provided comparative tracking data.

Randomized controlled pilot trial of naloxone‐on‐release to prevent post‐prison opioid overdose deaths

PubMed Central

Parmar, Mahesh K. B.; Strang, John; Choo, Louise; Meade, Angela M.

2016-01-01

Abstract Background and Aims Naloxone is an opioid antagonist used for emergency resuscitation following opioid overdose. Prisoners with a history of heroin injection have a high risk of drug‐related death soon after release from prison. The NALoxone InVEstigation (N‐ALIVE) pilot trial (ISRCTN34044390) tested feasibility measures for randomized provision of naloxone‐on‐release (NOR) to eligible prisoners in England. Design. Parallel‐group randomized controlled pilot trial. Setting English prisons. Participants A total of 1685 adult heroin injectors, incarcerated for at least 7 days pre‐randomization, release due within 3 months and more than 6 months since previous N‐ALIVE release. Intervention Using 1 : 1 minimization, prisoners were randomized to receive on release a pack containing either a single ‘rescue’ injection of naloxone or a control pack with no syringe. Measurements Key feasibility outcomes were tested against prior expectations: on participation (14 English prisons; 2800 prisoners), consent (75% for randomization), returned prisoner self‐questionnaires (RPSQs: 207), NOR‐carriage (75% in first 4 weeks) and overdose presence (80%). Findings Prisons (16) and prisoners (1685) were willing to participate [consent rate, 95% confidence interval (CI) = 70–74%]; 218 RPSQs were received; NOR‐carriage (95% CI = 63–79%) and overdose presence (95% CI = 75–84%) were as expected. We randomized 842 to NOR and 843 to control during 30 months but stopped early, because only one‐third of NOR administrations were to the ex‐prisoner. Nine deaths within 12 weeks of release were registered for 1557 randomized participants released before 9 December 2014. Conclusions Large randomized trials are feasible with prison populations. Provision of take‐home emergency naloxone prior to prison release may be a life‐saving interim measure to prevent heroin overdose deaths among ex‐prisoners and the wider population. PMID:27776382

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

PubMed

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

2017-04-01

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

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

PubMed Central

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

2016-01-01

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

A prospective cohort and extended comprehensive-cohort design provided insights about the generalizability of a pragmatic trial: the ProtecT prostate cancer trial.

PubMed

Donovan, Jenny L; Young, Grace J; Walsh, Eleanor I; Metcalfe, Chris; Lane, J Athene; Martin, Richard M; Tazewell, Marta K; Davis, Michael; Peters, Tim J; Turner, Emma L; Mills, Nicola; Khazragui, Hanan; Khera, Tarnjit K; Neal, David E; Hamdy, Freddie C

2018-04-01

Randomized controlled trials (RCTs) deliver robust internally valid evidence but generalizability is often neglected. Design features built into the Prostate testing for cancer and Treatment (ProtecT) RCT of treatments for localized prostate cancer (PCa) provided insights into its generalizability. Population-based cluster randomization created a prospective study of prostate-specific antigen (PSA) testing and a comprehensive-cohort study including groups choosing treatment or excluded from the RCT, as well as those randomized. Baseline information assessed selection and response during RCT conduct. The prospective study (82,430 PSA-tested men) represented healthy men likely to respond to a screening invitation. The extended comprehensive cohort comprised 1,643 randomized, 997 choosing treatment, and 557 excluded with advanced cancer/comorbidities. Men choosing treatment were very similar to randomized men except for having more professional/managerial occupations. Excluded men were similar to the randomized socio-demographically but different clinically, representing less healthy men with more advanced PCa. The design features of the ProtecT RCT provided data to assess the representativeness of the prospective cohort and generalizability of the findings of the RCT. Greater attention to collecting data at the design stage of pragmatic trials would better support later judgments by clinicians/policy-makers about the generalizability of RCT findings in clinical practice. Copyright © 2018 The Authors. Published by Elsevier Inc. All rights reserved.

Patient navigation to promote smoking cessation among low-income primary care patients: a pilot randomized controlled trial.

PubMed

Lasser, Karen E; Kenst, Karey S; Quintiliani, Lisa M; Wiener, Renda Soylemez; Murillo, Jennifer; Pbert, Lori; Xuan, Ziming; Bowen, Deborah J

2013-01-01

We conducted a pilot randomized controlled trial to determine the feasibility and acceptability of a patient navigation intervention. Forty-seven smokers from one safety-net hospital were randomized to either a control group, in which they received a smoking cessation brochure and a list of smoking cessation resources, or a navigation group, in which they received the smoking cessation brochure, a list of smoking cessation resources, and patient navigation. Follow-up data were obtained for 33 participants. Nine (47.4%) of 19 of navigation group participants had engaged in smoking cessation treatment by 3 months versus 6 (42.9%) of 14 control group participants (chi-square p = ns). Patient navigation to promote engagement in smoking cessation treatment was feasible and acceptable to participants.

Improving prospective memory in persons with Parkinson disease: A randomized controlled trial

PubMed Central

Foster, Erin R.; McDaniel, Mark A.; Rendell, Peter G.

2017-01-01

Background Prospective memory is essential for productive and independent living and necessary for compliance with prescribed health behaviors. Parkinson disease (PD) can cause prospective memory deficits that are associated with activity limitations and reduced quality of life. Forming implementation intentions is an encoding strategy that may improve prospective memory in this population. Objective To determine the effect of implementation intentions on prospective memory performance in PD. Methods This was a laboratory-based randomized controlled trial. Participants with mild to moderate PD without dementia (N = 62) performed a computerized prospective memory test (Virtual Week) under standard instructions. One week later they were randomly allocated to perform it again while using either implementation intentions or a rehearsal encoding strategy. Results Prospective memory performance was better with the use of both strategies relative to standard instructions. This effect was larger for tasks with event-based compared to time-based cues. In addition, implementation intentions resulted in a larger effect than rehearsal for the non-repeated tasks. Conclusions Strategies that support full encoding of prospective memory cues and actions can improve prospective memory performance among people with PD, particularly for tasks with cues that are readily available in the environment. Implementation intentions may be more effective than rehearsal for non-repeated tasks, but this finding warrants verification. Future work should address transfer of strategy use from the laboratory to everyday life. Targeted strategies to manage prospective memory impairment could improve function and quality of life and significantly impact clinical care for people with PD. (NCT01469741) PMID:28176547

Development and Pilot Evaluation of an Internet-Facilitated Cognitive-Behavioral Intervention for Maternal Depression

ERIC Educational Resources Information Center

Sheeber, Lisa B.; Seeley, John R.; Feil, Edward G.; Davis, Betsy; Sorensen, Erik; Kosty, Derek B.; Lewinsohn, Peter M.

2012-01-01

Objective: Develop and pilot an Internet-facilitated cognitive-behavioral treatment intervention for depression, tailored to economically disadvantaged mothers of young children. Method: Mothers (N = 70) of children enrolled in Head Start, who reported elevated levels of depressive symptoms, were randomized to either the 8-session,…

Cognitive Behavioral Treatment for Recurrent Binge Eating in Adolescent Girls: A Pilot Trial

ERIC Educational Resources Information Center

DeBar, Lynn L.; Wilson, G. Terence; Yarborough, Bobbi Jo; Burns, Beryl; Oyler, Barbara; Hildebrandt, Tom; Clarke, Gregory N.; Dickerson, John; Striegel, Ruth H.

2013-01-01

There is a need for treatment interventions to address the high prevalence of disordered eating throughout adolescence and early adulthood. We developed an adolescent-specific manualized CBT protocol to treat female adolescents with recurrent binge eating and tested its efficacy in a small, pilot randomized controlled trial. We present lessons…

Design and Outcomes of a "Mothers In Motion" Behavioral Intervention Pilot Study

ERIC Educational Resources Information Center

Chang, Mei-Wei; Nitzke, Susan; Brown, Roger

2010-01-01

Objective: This paper describes the design and findings of a pilot "Mothers In Motion" (P-"MIM") program. Design: A randomized controlled trial that collected data via telephone interviews and finger stick at 3 time points: baseline and 2 and 8 months post-intervention. Setting: Three Special Supplemental Nutrition Program for…

Enhancing Reading Comprehension among Students with High-Functioning Autism Spectrum Disorder: A Randomized Pilot Study

ERIC Educational Resources Information Center

Roux, Catherine; Dion, Eric; Barrette, Anne

2015-01-01

Reading with comprehension is a challenge for students with high-functioning autism spectrum disorder. Unfortunately, research has little to offer to teachers trying to help these students. The present study pilots a new intervention targeting vocabulary, main idea identification, anaphoric relations, and text structure. Students (N = 13, M…

Randomized controlled trial comparing retroperitoneal laparoscopic pyelolithotomy versus percutaneous nephrolithotomy for the treatment of large renal pelvic calculi: a pilot study.

PubMed

Li, Sheng; Liu, Tong-Zu; Wang, Xing-Huan; Zeng, Xian-Tao; Zeng, Guang; Yang, Zhong-Hua; Weng, Hong; Meng, Zhe; Huang, Jing-Yu

2014-08-01

To evaluate the efficacy and safety of retroperitoneal laparoscopic pyelolithotomy (RLP) versus percutaneous nephrolithotomy (PCNL) for large renal pelvic calculi using a randomized controlled trial. Patients with large renal pelvic calculi were prospectively randomized using matched-pair analysis (1:1 scenario) into either the RLP group or the PCNL group. The patients in each group underwent the procedure accordingly. Treatment efficacy, safety, and complications were evaluated after surgery. Finally, 178 eligible patients were included and the demographics and mean stone size of two groups were similar. We found no significant differences in the mean postoperative hospital stay (4.5±2.3 vs. 4.3±1.3 days), rate of blood transfusion (0% vs. 1.1%), conversion rate (0% vs. 3.4%), and rate of total postoperative complication (p>0.05). The procedural duration and mean drop in hemoglobin levels were significantly lower in the RLP group as compared with the PCNL group (90.87±33.4 vs. 116.8±44.4 minutes, p<0.001; 0.9±0.5 vs. 1.7±1.3 g/dL, p<0.001, respectively). Significant differences were also observed in the stone-free rate (98% vs. 90%, p=0.03) and postoperative fever rate (3.4% vs. 13.5%, p=0.02). Current evidence suggests that PCNL and RLP are both effective and safe for the treatment of large renal pelvic calculi. Our study shows that, compared with the PCNL approach, RLP for large renal pelvic stone resulted in shorter operative time, less bleeding, less postoperative fever, and a higher stone-free rate. Data from larger, multicenter randomized controlled trials of high quality are needed to further confirm our findings.

Multipoint Pacing versus conventional ICD in Patients with a Narrow QRS complex (MPP Narrow QRS trial): study protocol for a pilot randomized controlled trial.

PubMed

Gasparini, Maurizio; Galimberti, Paola; Bragato, Renato; Ghio, Stefano; Raineri, Claudia; Landolina, Maurizio; Chieffo, Enrico; Lunati, Maurizio; Mulargia, Ederina; Proclemer, Alessandro; Facchin, Domenico; Rordorf, Roberto; Vicentini, Alessandro; Marcantoni, Lina; Zanon, Francesco; Klersy, Catherine

2016-12-03

Despite an intensive search for predictors of the response to cardiac resynchronization therapy (CRT), the QRS duration remains the simplest and most robust predictor of a positive response. QRS duration of ≥ 130 ms is considered to be a prerequisite for CRT; however, some studies have shown that CRT may also be effective in heart failure (HF) patients with a narrow QRS (<130 ms). Since CRT can now be performed by pacing the left ventricle from multiple vectors via a single quadripolar lead, it is possible that multipoint pacing (MPP) might be effective in HF patients with a narrow QRS. This article reports the design of the MPP Narrow QRS trial, a prospective, randomized, multicenter, controlled feasibility study to investigate the efficacy of MPP using two LV pacing vectors in patients with a narrow QRS complex (100-130 ms). Fifty patients with a standard ICD indication will be enrolled and randomized (1:1) to either an MPP group or a Standard ICD group. All patients will undergo a low-dose dobutamine stress echo test and only those with contractile reserve will be included in the study and randomized. The primary endpoint will be the percentage of patients in each group that have reverse remodeling at 12 months, defined as a reduction in left ventricular end-systolic volume (LVESV) of >15% from the baseline. This feasibility study will determine whether MPP improves reverse remodeling, as compared with standard ICD, in HF patients who have a narrow QRS complex (100-130 ms). ClinicalTrials.gov, NCT02402816 . Registered on 25 March 2015.

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.

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.

Randomized Controlled Trial of the Resilience and Coping Intervention (RCI) with Undergraduate University Students

ERIC Educational Resources Information Center

Houston, J. Brian; First, Jennifer; Spialek, Matthew L.; Sorenson, Mary E.; Mills-Sandoval, Toby; Lockett, McKenzie; First, Nathan L.; Nitiéma, Pascal; Allen, Sandra F.; Pfefferbaum, Betty

2017-01-01

Objective: The purpose of this pilot study was to evaluate the Resilience and Coping Intervention (RCI) with college students. Participants: College students (aged 18-23) from a large Midwest US university who volunteered for a randomized controlled trial during the 2015 spring semester. Methods: College students were randomly assigned to an…

An educational intervention on drug interactions and contraceptive options for epilepsy patients: a pilot randomized controlled trial.

PubMed

Mody, Sheila K; Haunschild, Carolyn; Farala, John Paul; Honerkamp-Smith, Gordon; Hur, Vivian; Kansal, Leena

2016-01-01

This pilot study investigates whether an educational handout could increase short-term information retention about drug interactions between antiepileptic drugs (AEDs) and hormonal contraceptives among female epilepsy patients of reproductive age. This is a pilot randomized controlled trial of an educational intervention among reproductive-age women with epilepsy in an academic neurology clinic. Investigators measured knowledge before and after participants received either usual care or the educational handout. The 10-question test assessed increased knowledge of which AEDs affected efficacy of certain hormonal contraceptives and was assessed by calculating the improvement in score between the pretest and posttest. The educational handout included the names of AEDs that have drug interactions with certain contraceptives and the efficacy of the contraceptives. A total of 42 epilepsy patients participated in this study. Fourteen participants were taking AEDs that are enzyme p450 inducers and 13 participants were taking Lamotrigine. Twenty women were randomized to receive the educational handout and 22 women were randomized to usual care. We found no statistical difference in the groups with regard to age, ethnicity or level of education. We found a significantly higher improvement in quiz scores in the educational handout group (3.65 point increase) compared to the usual care group (0.68 point increase) as calculated by the Student's two-sample t test (p<.001). An educational handout on drug interactions and contraceptives resulted in increased short-term information retention on this topic among reproductive-age female epilepsy patients. This pilot study highlights the need for further larger studies to evaluate the impact of educational interventions on improving patient knowledge about the drug interaction of AEDs and hormonal contraceptives. Copyright © 2016. Published by Elsevier Inc.

The use of a biologic topical haemostatic agent (TachoSil(®)) for the prevention of postoperative bleeding in patients on antithrombotic therapy undergoing thyroid surgery: A randomised controlled pilot trial.

PubMed

Erdas, Enrico; Medas, Fabio; Podda, Francesco; Furcas, Silvia; Pisano, Giuseppe; Nicolosi, Angelo; Calò, Pietro Giorgio

2015-08-01

Anticoagulants and antiplatelet agents are well-known risk factors for post-operative bleeding. The aim of this prospective, randomized pilot study was to evaluate the effectiveness of a topical haemostatic agent, namely TachoSil, for the prevention of postoperative bleeding in patients on antithrombotic therapy undergoing thyroidectomy. Perioperative management and some distinctive aspects of cervical haematomas were also discussed. Between January 2012 and May 2014, all patients taking vitamin K antagonists (VKAs) or acetyl salicylic acid (ASA) scheduled for total thyroidectomy were enrolled and randomly allocated to group 1 (standard haemostasis) and group 2 (standard haemostasis + TachoSil). Antithrombotic drugs were always suspended prior to surgery and, when indicated, replaced by bridging anticoagulation with low-molecular-weight heparin. The primary endpoint was the incidence of postoperative cervical haematomas. A total of 70 patients were included in the study, representing 8.5% (70/820) of all patients who underwent thyroidectomies in the same period. The overall rate of post-operative cervical haematoma was 7.1% (5/70) and reached 14.8% (4/27) in patients on VKA therapy. All but one occurred more than 24 h after surgery (32nd hour, 8th, 10th, and 13th days). Group 1 (37 patients) and group 2 (33 patients) were well-matched according to clinical and demographic features. Postoperative haematoma was observed in 2/37 patients (5.4%) recruited in the Group 1 and 3/33 patients (9.1%) recruited in the Group 2 (P = 0.661). Patients taking antithrombotic drugs represent a major problem in thyroid surgery. The incidence of bleeding after thyroidectomy is significantly high and the use of TachoSil do not seem effective in preventing its occurrence. However, larger multicenter study is needed to confirm these results. Copyright © 2015 IJS Publishing Group Limited. Published by Elsevier Ltd. All rights reserved.

The impact of patient education and shared decision making on hospital readmissions for COPD

PubMed Central

Collinsworth, Ashley W; Brown, Rachel M; James, Cameron S; Stanford, Richard H; Alemayehu, Daniel; Priest, Elisa L

2018-01-01

Purpose Education on the self-management of COPD has been shown to improve patients’ quality of life and reduce hospital admissions. This study aimed to assess the feasibility of a pilot, pragmatic COPD Chronic Care (CCC) education program led by registered respiratory therapists and determine the CCC’s impact on hospital readmissions, patient activation, and health status. Patients and methods This was a prospective, randomized, pilot study of inpatients with COPD admitted to a US community hospital between August 2014 and February 2016. In total, 308 patients were randomized 1:1 to receive standard care with or without the CCC program. Outcomes included the number of patients completing the program, frequency and time to first all-cause and COPD-related hospital readmissions, and changes in the Patient Activation Measure (PAM) and COPD Assessment Test (CAT). Results Overall, 37% (n=52) of patients in the CCC group and 29% (n=48) of patients in the control group remained in the study for 6 months and completed all follow-up phone calls. In total, 74% (n=105) of patients in the CCC group and 69% (n=115) of patients in the control group had at least one readmission (P=0.316). The time to first all-cause and COPD-related readmission appeared shorter for patients in the CCC group compared with the control group (mean [standard deviation]: 50.2 [54.5] vs 59.9 [63.1] days and 95.1 [80.2] vs 113.7 [82.4] days, respectively; both P=0.231). Patients experienced significant improvement from baseline in mean PAM (both groups) and CAT (CCC group) scores. Conclusion Utilizing respiratory therapists to lead a chronic care education program for COPD in a community hospital was feasible. Although CCC patients showed improvements in perceived symptom severity, they were readmitted sooner than control group patients. However, the program did not impact the frequency of hospital readmissions. A more comprehensive disease management program may be needed to improve outcomes. PMID:29731620

The impact of patient education and shared decision making on hospital readmissions for COPD.

PubMed

Collinsworth, Ashley W; Brown, Rachel M; James, Cameron S; Stanford, Richard H; Alemayehu, Daniel; Priest, Elisa L

Education on the self-management of COPD has been shown to improve patients' quality of life and reduce hospital admissions. This study aimed to assess the feasibility of a pilot, pragmatic COPD Chronic Care (CCC) education program led by registered respiratory therapists and determine the CCC's impact on hospital readmissions, patient activation, and health status. This was a prospective, randomized, pilot study of inpatients with COPD admitted to a US community hospital between August 2014 and February 2016. In total, 308 patients were randomized 1:1 to receive standard care with or without the CCC program. Outcomes included the number of patients completing the program, frequency and time to first all-cause and COPD-related hospital readmissions, and changes in the Patient Activation Measure (PAM) and COPD Assessment Test (CAT). Overall, 37% (n=52) of patients in the CCC group and 29% (n=48) of patients in the control group remained in the study for 6 months and completed all follow-up phone calls. In total, 74% (n=105) of patients in the CCC group and 69% (n=115) of patients in the control group had at least one readmission ( P =0.316). The time to first all-cause and COPD-related readmission appeared shorter for patients in the CCC group compared with the control group (mean [standard deviation]: 50.2 [54.5] vs 59.9 [63.1] days and 95.1 [80.2] vs 113.7 [82.4] days, respectively; both P =0.231). Patients experienced significant improvement from baseline in mean PAM (both groups) and CAT (CCC group) scores. Utilizing respiratory therapists to lead a chronic care education program for COPD in a community hospital was feasible. Although CCC patients showed improvements in perceived symptom severity, they were readmitted sooner than control group patients. However, the program did not impact the frequency of hospital readmissions. A more comprehensive disease management program may be needed to improve outcomes.

A Pilot RCT of an Internet Intervention to Reduce the Risk of Alcohol-Exposed Pregnancy.

PubMed

Ingersoll, Karen; Frederick, Christina; MacDonnell, Kirsten; Ritterband, Lee; Lord, Holly; Jones, Brogan; Truwit, Lauren

2018-06-01

Preventing alcohol-exposed pregnancies (AEPs) could reduce the incidence of fetal alcohol spectrum disorders. Previous face-to-face interventions significantly reduced risk for AEP, but a scalable intervention is needed to reach more women at risk. This study compared a 6 Core automated, interactive, and tailored Internet intervention, the Contraception and Alcohol Risk Reduction Internet Intervention (CARRII), to a static patient education (PE) website for its effect on AEP risk. Participants were recruited online to a pilot randomized clinical trial (RCT) with baseline, 9 weeks posttreatment, and 6-month (6-M) follow-up assessments. Seventy-one women completed online questionnaires and telephone interviews and were randomized to CARRII (n = 36) or PE (n = 35). Primary outcomes were rates of risky drinking, unprotected sex episodes, and AEP risk, collected from online prospective diaries. CARRII participants showed significant reductions in rate of unprotected sex from pretreatment (88.9%) to posttreatment (70.6%) (p < 0.04) and to 6-M follow-up (51.5%) (p = 0.001); rate of risky drinking from pretreatment (75.0%) to posttreatment (50.0%) (p < 0.02), but insignificant change from pretreatment to 6-M follow-up (57.6%) (p < 0.09); and rate of AEP risk from pretreatment (66.7%) to posttreatment (32.4%) (p = 0.001) and to 6-M follow-up (30.3%) (p = 0.005). PE participants demonstrated no significant changes on all 3 variables across all time points. Intent-to-treat group-by-time tests were not significant, but power was limited by missing diaries. Over 72% of CARRII participants completed all 6 Cores. Exploratory analyses suggest that higher program utilization is related to change. These data show that CARRII was acceptable, feasible, promising to reduce AEP risk, and merits further testing in a fully powered RCT. Copyright © 2018 by the Research Society on Alcoholism.

Dual Therapy with Aspirin and Cilostazol May Improve Platelet Aggregation in Noncardioembolic Stroke Patients: A Pilot Study.

PubMed

Ohnuki, Yoichi; Ohnuki, Yuko; Kohara, Saori; Shimizu, Mie; Takizawa, Shunya

2017-01-01

Objective Some previous studies have found clinical benefit of dual antiplatelet therapy with aspirin and cilostazol for prevention of secondary stroke, but the physiological mechanism involved remains unknown. We aimed to clarify the effects of aspirin/cilostazol therapy on the platelet and endothelial functions of patients with acute noncardioembolic ischemic stroke, in comparison to patients who were treated with aspirin alone. Methods The present randomized prospective pilot study enrolled 24 patients within a week after the onset of noncardioembolic ischemic stroke. The patients were randomly allocated to receive aspirin (100 mg/day) (A group; 11 patients) or cilostazol (200 mg/day) plus aspirin (100 mg/day) (CA group; 13 patients). We measured platelet aggregation, platelet activation, and the thrombomodulin (TM), highly sensitive C-reactive protein (hs-CRP), intercellular adhesion molecule-1 (ICAM-1), vascular cell adhesion molecule-1 (VCAM-1) and von Willebrand (vWF) antigen levels and vWF activity over a 4-week period after enrollment. Results There was no significant difference in the platelet functions of the A and CA groups. However, the platelet aggregation induced by adenosine diphosphate (ADP) was decreased at 2 and 4 weeks (p<0.05) after treatment in comparison to the pre-treatment values in the CA group, but not in the A group. Platelet activation, and the hs-CRP, TM, ICAM-1, VCAM-1 and vWF values did not significantly decrease after treatment in either group. Conclusion Although there were no significant differences in platelet aggregation, platelet activation or the endothelial biomarker levels of the A and CA groups, dual therapy with aspirin and cilostazol inhibited platelet aggregation in comparison to the pre-treatment values, similarly to patients who received aspirin alone. This may suggest the clinical usefulness of dual therapy with aspirin and cilostazol in the treatment of patients with noncardioembolic ischemic stroke.

Clinical Outcomes of a Pneumatic Unloader Brace for Kellgren-Lawrence Grades 3 to 4 Osteoarthritis: A Minimum 1-Year Follow-Up Study.

PubMed

Chughtai, Morad; Bhave, Anil; Khan, Sabahat Z; Khlopas, Anton; Ali, Osman; Harwin, Steven F; Mont, Michael A

2016-11-01

The use of a pneumatic unloader brace has been shown in pilot studies to decrease pain and increase muscle strength in patients with knee osteoarthritis (OA). Therefore, we analyzed patients who had knee OA, and either received a pneumatic unloader brace and conventional treatment or conventional treatment alone. Specifically, we assessed: (1) use of pain relieving injections; (2) opioid consumption; and (3) the eventual need for total knee arthroplasty (TKA) in the above-mentioned cohort. We performed an analysis of a longitudinally maintained database of patients from a prospective, randomized, single center study. This study randomized patients who had Kellgren-Lawrence grades 3 to 4 to receive either a pneumatic unloader brace and conventional treatment or conventional treatment alone. The brace cohort comprised 11 patients with a mean age of 55 years (range, 37-70 years). The final matched cohort comprised 25 patients with a mean age of 63 years (range, 41-86 years). The minimum follow-up was 1 year. There was a lower proportion of patients who underwent an eventual TKA in the bracing cohort as compared with the nonbracing cohort (18 vs. 36%). The mean time to TKA was longer in the bracing cohort as compared with the nonbracing cohort (482 vs. 389 days). The proportion of patients who used opioids was similar in both groups (27 vs. 22%). There was a significantly lower number of patients who received injections in the bracing cohort as compared with the nonbracing cohort (46 vs. 83%, p  = 0.026). The bracing cohort had received a significantly lower number of injections and a lower rate of subsequent TKA as compared with the nonbracing cohort. The mean time to TKA was also longer among the bracing cohort. These results may demonstrate the potential of this brace to reduce the need for and prolonging the time to TKA. Performing larger prospective randomized studies, with built-in compliance monitors is warranted. This brace may be a valuable adjunct to the current knee OA treatment armamentarium pending further investigation. Thieme Medical Publishers 333 Seventh Avenue, New York, NY 10001, USA.

Early Rehabilitation of Distal Radius Fractures Stabilized by Volar Locking Plate: A Prospective Randomized Pilot Study

PubMed Central

Quadlbauer, Stefan; Pezzei, Christoph; Jurkowitsch, Josef; Kolmayr, Brigitta; Keuchel, Tina; Simon, Daniel; Hausner, Thomas; Leixnering, Martin

2016-01-01

Background Distal radius fractures are very common and an increased incidence of 50% is estimated by 2030. Therefore, both operative and postsurgical treatment remains pertinent. Main aim in treating intra-articular fractures is to restore the articular surface by internal fixation and early mobilization (EM). Questions/Purposes The purpose of this study was to compare functional results between EM immediately after surgery and 5 weeks of immobilization (IM). Patients and Methods In a randomized prospective study, 30 patients with an isolated distal radius fracture were treated by open reduction and internal fixation using a single volar locking plate excluding bone graft. Fifteen patients were randomized in the EM group and 15 in the IM group. At 6 weeks, 9 weeks, 3 months, 6 months, and 1 year postsurgery, range of motion, grip strength and X-rays were evaluated. Additionally, Quick Disability of the Arm, Shoulder and Hand (QuickDASH) questionnaire, Patient-Rated Wrist Evaluation (PRWE), modified Green O'Brien (Mayo) score, and pain according to the Visual Analog Scale score were analyzed. Results Patients in the EM group had a significantly better range of motion in the sagittal plane, in grip strength up to 6 months, in the frontal plane up to 9 weeks, and in forearm rotation up to 6 weeks. Also QuickDASH and PRWE scores were better up to 6 weeks postsurgery. The Green O'Brien score differed significantly up to 1 year. At 1 year, 93% “excellent” and “good” results in the Green O'Brien score with a mean QuickDASH of 5.98 ± 10.94 and PRWE score of 4.27 ± 9.23 were observed in the EM group. No differences regarding loss of reduction, pain, duration of physiotherapy, and sick leave were noted. Conclusion EM of surgically treated distal radius fractures (without bone graft) is a safe method for postoperative aftercare and leads to an improved range of motion and grip strength at 6 months postsurgery compared with an IM of 5 weeks. Level of Evidence This is a level Ib clinical study. PMID:28428911

Integration of altitude and airspeed information into a primary flight display via moving-tape formats: Evaluation during random tracking task

NASA Technical Reports Server (NTRS)

Abbott, Terence S.; Nataupsky, Mark; Steinmetz, George G.

1987-01-01

A ground-based aircraft simulation study was conducted to determine the effects on pilot preference and performance of integrating airspeed and altitude information into an advanced electronic primary flight display via moving-tape (linear moving scale) formats. Several key issues relating to the implementation of moving-tape formats were examined in this study: tape centering, tape orientation, and trend information. The factor of centering refers to whether the tape was centered about the actual airspeed or altitude or about some other defined reference value. Tape orientation refers to whether the represented values are arranged in descending or ascending order. Two pilots participated in this study, with each performing 32 runs along seemingly random, previously unknown flight profiles. The data taken, analyzed, and presented consisted of path performance parameters, pilot-control inputs, and electrical brain response measurements.

Promoting healthy transition to college through mindfulness training with first-year college students: Pilot randomized controlled trial.

PubMed

Dvořáková, Kamila; Kishida, Moé; Li, Jacinda; Elavsky, Steriani; Broderick, Patricia C; Agrusti, Mark R; Greenberg, Mark T

2017-01-01

Given the importance of developmental transitions on young adults' lives and the high rates of mental health issues among U.S. college students, first-year college students can be particularly vulnerable to stress and adversity. This pilot study evaluated the effectiveness and feasibility of mindfulness training aiming to promote first-year college students' health and wellbeing. 109 freshmen were recruited from residential halls (50% Caucasian, 66% female). Data collection was completed in November 2014. A randomized control trial was conducted utilizing the Learning to BREATHE (L2B) program, a universal mindfulness program adapted to match the developmental tasks of college transition. Participation in the pilot intervention was associated with significant increase in students' life satisfaction, and significant decrease in depression and anxiety. Marginally significant decrease was found for sleep issues and alcohol consequences. Mindfulness-based programs may be an effective strategy to enhance a healthy transition into college.

Development of a tobacco cessation intervention for Alaska Native youth

PubMed Central

Patten, Christi A.; Fadahunsi, Oluwole; Hanza, Marcelo; Smith, Christina M.; Hughes, Christine A.; Brockman, Tabetha A.; Boyer, Rahnia; Decker, Paul A.; Luger, Elizabeth; Sinicrope, Pamela S.; Offord, Kenneth P.

2013-01-01

Tobacco cessation treatments have not been evaluated among Alaska Native (AN) adolescents. This pilot study evaluated the feasibility and acceptability of a targeted cessation intervention developed for AN youth. Intervention components were informed by prior focus groups assessing treatment preferences among AN youth, a social cognitive theoretical framework and feedback obtained from a teen advisory group. The intervention consisted of a weekend program where youth traveled by small airplane from their villages to stay overnight with other adolescents who quit tobacco use together. The program included recreational activities, talking circles, personal stories from elders and teen advisors, and cognitive behavioral counseling. Two intervention pilots were conducted from October 2010 to January 2011 using a non-randomized, uncontrolled study design with assessments at baseline and six-week follow-up. One village in Western Alaska was selected for each pilot with a targeted enrollment of 10 adolescents each. Participants were recruited for each pilot within five days, but recruitment challenges and ‘‘lessons learned’’ are described. The first pilot enrolled nine adolescents (all female) aged 13–16 years; all nine attended the intervention program and 78% (7/9) completed follow-up. The second pilot enrolled 12 adolescents (eight females, four males) aged 12–17 years, of which seven attended the intervention program. Six of these seven participants (86%) completed follow-up. In both pilots, participants rated the intervention as highly acceptable. A targeted cessation intervention was feasible and acceptable to AN youth. The intervention will be tested for efficacy in a subsequent randomized controlled trial. PMID:24058327

Developing Substance Use Programming for Person-Oriented Recovery and Treatment (SUPPORT): protocol for a pilot randomized controlled trial.

PubMed

Watson, Dennis P; Ray, Bradley; Robison, Lisa; Xu, Huiping; Edwards, Rhiannon; Salyers, Michelle P; Hill, James; Shue, Sarah

2017-01-01

There is a lack of evidence-based substance use disorder treatment and services targeting returning inmates. Substance Use Programming for Person-Oriented Recovery and Treatment (SUPPORT) is a community-driven, recovery-oriented approach to substance abuse care which has the potential to address this service gap. SUPPORT is modeled after Indiana's Access to Recovery program, which was closed due to lack of federal support despite positive improvements in clients' recovery outcomes. SUPPORT builds on noted limitations of Indiana's Access to Recovery program. The ultimate goal of this project is to establish SUPPORT as an effective and scalable recovery-oriented system of care. A necessary step we must take before launching a large clinical trial is pilot testing the SUPPORT intervention. The pilot will take place at Public Advocates in Community Re-Entry (PACE), nonprofit serving individuals with felony convictions who are located in Marion County, Indiana (Indianapolis). The pilot will follow a basic parallel randomized design to compare clients receiving SUPPORT with clients receiving standard services. A total of 80 clients within 3 months of prison release will be recruited to participate and randomly assigned to one of the two intervention arms. Quantitative measures will be collected at multiple time points to understand SUPPORT's impact on recovery capital and outcomes. We will also collect qualitative data from SUPPORT clients to better understand their program and post-discharge experiences. Successful completion of this pilot will prepare us to conduct a multi-site clinical trial. The ultimate goal of this future work is to develop an evidence-based and scalable approach to treating substance use disorder among persons returning to society after incarceration. ClinicalTrials.gov (Clinical Trials ID: NCT03132753 and Protocol Number: 1511731907). Registered 28 April 2017.

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.

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)

Weight management for overweight and obese men delivered through professional football clubs: a pilot randomized trial

PubMed Central

2013-01-01

Background The prevalence of male obesity is increasing, but men are less likely than women to attend existing weight management programmes. We have taken a novel approach to reducing perceived barriers to weight loss for men by using professional football (soccer) clubs to encourage participation in a weight management group programme, gender-sensitised in content and style of delivery. Football Fans in Training (FFIT) provides 12 weeks of weight loss, physical activity and healthy eating advice at top professional football clubs in Scotland. This pilot randomized trial explored the feasibility of using these clubs as a setting for a randomized controlled trial of 12 month weight loss following men’s participation in FFIT. Methods A two-arm pilot trial at two Scottish Premier League football clubs (one large, one smaller), with 103 men (aged 35–65, body mass index (BMI) ≥27 kg/m2) individually randomized to the intervention (n=51, received the pilot programme (p-FFIT) immediately) and waitlist comparison (n=52, received p-FFIT after four months) groups. Feasibility of recruitment, randomization, data collection and retention were assessed. Objective physical measurements (weight, waist circumference, blood pressure, body composition) and questionnaires (self-reported physical activity, diet, alcohol consumption, psychological outcomes) were obtained from both groups by fieldworkers trained to standard protocols at baseline and 12 weeks, and from the intervention group at 6 and 12 months. Qualitative methods elicited men’s experiences of participation in the pilot trial. Results Following a short recruitment period, the recruitment target was achieved at the large, but not smaller, club. Participants’ mean age was 47.1±8.4 years; mean BMI 34.5±5.0 kg/m2. Retention through the trial was good (>80% at 12 weeks and 6 months; >75% at 12 months), and 76% attended at least 80% of available programme delivery sessions. At 12 weeks, the intervention group lost significantly more weight than the comparison group (4.6% c.f. -0.6%, p<.001) and many maintained this to 12 months (intervention group baseline-12 month weight loss: 3.5%, p<.001). There were also improvements in self-reported physical activity and diet, many sustained long term. Conclusions The results demonstrated the feasibility of trial procedures and the potential of FFIT to engage men in sustained weight loss and positive lifestyle change. They supported the conduct of a fully-powered randomized controlled trial. PMID:24171842

Treatment of Aspergillus fumigatus in patients with cystic fibrosis: a randomized, placebo-controlled pilot study.

PubMed

Aaron, Shawn D; Vandemheen, Katherine L; Freitag, Andreas; Pedder, Linda; Cameron, William; Lavoie, Annick; Paterson, Nigel; Wilcox, Pearce; Rabin, Harvey; Tullis, Elizabeth; Morrison, Nancy; Ratjen, Felix

2012-01-01

Many patients with cystic fibrosis develop persistent airway infection/colonization with Aspergillus fumigatus, however the impact of A. fumigatus on clinical outcomes remains unclear. The objective of this study was to determine whether treatment directed against Aspergillus fumigatus improves pulmonary function and clinical outcomes in patients with cystic fibrosis (CF). We performed a double-blind randomized placebo-controlled pilot clinical trial involving 35 patients with CF whose sputum cultures were chronically positive for A. fumigatus. Participants were centrally randomized to receive either oral itraconazole 5 mg/kg/d (N = 18) or placebo (N = 17) for 24 weeks. The primary outcome was the proportion of patients who experienced a respiratory exacerbation requiring intravenous antibiotics over the 24 week treatment period. Secondary outcomes included changes in FEV(1) and quality of life. Over the 24 week treatment period, 4 of 18 (22%) patients randomized to itraconazole experienced a respiratory exacerbation requiring intravenous antibiotics, compared to 5 of 16 (31%) placebo treated patients, P = 0.70. FEV(1) declined by 4.62% over 24 weeks in the patients randomized to itraconazole, compared to a 0.32% improvement in the placebo group (between group difference = -4.94%, 95% CI: -15.33 to 5.45, P = 0.34). Quality of life did not differ between the 2 treatment groups throughout the study. Therapeutic itraconazole blood levels were not achieved in 43% of patients randomized to itraconazole. We did not identify clinical benefit from itraconazole treatment for CF patients whose sputum was chronically colonized with A. fumigatus. Limitations of this pilot study were its small sample size, and failure to achieve therapeutic levels of itraconazole in many patients. ClinicalTrials.gov NCT00528190.

The Family Navigator: A Pilot Intervention to Support Intensive Care Unit Family Surrogates.

PubMed

Torke, Alexia M; Wocial, Lucia D; Johns, Shelley A; Sachs, Greg A; Callahan, Christopher M; Bosslet, Gabriel T; Slaven, James E; Perkins, Susan M; Hickman, Susan E; Montz, Kianna; Burke, Emily S

2016-11-01

Communication problems between family surrogates and intensive care unit (ICU) clinicians have been documented, but few interventions are effective. Nurses have the potential to play an expanded role in ICU communication and decision making. To conduct a pilot randomized controlled trial of the family navigator (FN), a distinct nursing role to address family members' unmet communication needs early in an ICU stay. An interprofessional team developed the FN protocol. A randomized controlled pilot intervention trial of the FN was performed in a tertiary referral hospital's ICU to test the feasibility and acceptability of the intervention. The intervention addressed informational and emotional communication needs through daily contact by using structured clinical updates, emotional and informational support modules, family meeting support, and follow-up phone calls. Twenty-six surrogate/patient pairs (13 per study arm) were enrolled. Surrogates randomized to the intervention had contact with the FN on 90% or more of eligible patient days. All surrogates agreed that they would recom mend the FN to other families. Open-ended comments from both surrogates and clinicians were uniformly positive. Having a fully integrated nurse empowered to facilitate decision making is a feasible intervention in an ICU and is well-received by ICU families and staff. A larger randomized controlled trial is needed to demonstrate impact on important outcomes, such as surrogates' well-being and decision quality. ©2016 American Association of Critical-Care Nurses.

A Pilot Randomized Controlled Trial of an Intervention to Promote Psychological Well-Being in Critically Ill Children: Soothing Through Touch, Reading, and Music.

PubMed

Rennick, Janet E; Stremler, Robyn; Horwood, Linda; Aita, Marilyn; Lavoie, Tanya; Majnemer, Annette; Antonacci, Marie; Knox, Alyssa; Constantin, Evelyn

2018-04-13

To examine the feasibility and acceptability of a PICU Soothing intervention using touch, reading, and music. Nonblinded, pilot randomized controlled trial. The PICU and medical-surgical wards of one Canadian pediatric hospital. Twenty PICU patients age 2-14 years old and their parents, randomized to an intervention group (n = 10) or control group (n = 10). PICU Soothing consisted of: 1) parental comforting (touch and reading), followed by 2) a quiet period with music via soft headbands, administered once daily throughout hospitalization. Acceptability and feasibility of the intervention and methods were assessed via participation rates, observation, measurement completion rates, semistructured interviews, and telephone calls. Psychological well-being was assessed using measures of distress, sleep, and child and parent anxiety in the PICU, on the wards and 3 months post discharge. Forty-four percent of parents agreed to participate. Seventy percent and 100% of intervention group parents responded positively to comforting and music, respectively. Most intervention group parents (70%) and all nurses felt children responded positively. All nurses found the intervention acceptable and feasible. Measurement completion rates ranged from 70% to 100%. Pilot data suggested lower intervention group child and parent anxiety after transfer to hospital wards. PICU Soothing is acceptable and feasible to conduct. Results support the implementation of a full-scale randomized controlled trial to evaluate intervention effectiveness.

The prevention of injuries in contact flag football.

PubMed

Kaplan, Yonatan; Myklebust, Grethe; Nyska, Meir; Palmanovich, Ezequiel; Victor, Jan; Witvrouw, Erik

2014-01-01

American flag football is a non-tackle, contact sport with many moderate to severe contact-type injuries reported. A previous prospective injury surveillance study by the authors revealed a high incidence of injuries to the fingers, face, knee, shoulder and ankle. The objectives of the study were to conduct a pilot-prospective injury prevention study in an attempt to significantly reduce the incidence and the severity of injuries as compared to a historical cohort, as well as to provide recommendations for a future prospective injury prevention study. A prospective injury prevention study was conducted involving 724 amateur male (mean age: 20.0 ± 3.1 years) and 114 female (mean age: 21.2 ± 7.2 years) players. Four prevention measures were implemented: the no-pocket rule, self-fitting mouth guards, ankle braces (for those players with recurrent ankle sprains) and an injury treatment information brochure. An injury surveillance questionnaire was administered to record all time-loss injuries sustained in game sessions. There was a statistically significant reduction in the number of injured players, the number of finger/hand injuries, the incidence rate and the incidence proportion between the two cohorts (p < 0.05). This one-season pilot prevention study has provided preliminary evidence that finger/hand injuries can be significantly reduced in flag football. Prevention strategies for a longer, prospective, randomised-controlled injury prevention study should include the strict enforcement of the no-pocket rule, appropriate head gear, the use of comfortable-fitting ankle braces and mouth guards, and changing the blocking rules of the game.

Evaluation of the "Energize Your Life!" Social Marketing Campaign Pilot Study to Increase Fruit Intake among Community College Students

ERIC Educational Resources Information Center

Shive, Steven E.; Morris, Michelle Neyman

2006-01-01

In this study, the authors evaluated the effectiveness of the "Energize Your Life!" social-marketing campaign pilot study to improve knowledge, attitudes, and fruit intake among community college students. The authors used a cross-sectional, quasi-experimental, pre- and posttest design. They randomly selected community college students…

Promoting Healthy Transition to College through Mindfulness Training with First-Year College Students: Pilot Randomized Controlled Trial

ERIC Educational Resources Information Center

Dvoráková, Kamila; Kishida, Moé; Li, Jacinda; Elavsky, Steriani; Broderick, Patricia C.; Agrusti, Mark R.; Greenberg, Mark T.

2017-01-01

Objective: Given the importance of developmental transitions on young adults' lives and the high rates of mental health issues among U.S. college students, first-year college students can be particularly vulnerable to stress and adversity. This pilot study evaluated the effectiveness and feasibility of mindfulness training aiming to promote…

Mindfulness for Teachers: A Pilot Study to Assess Effects on Stress, Burnout, and Teaching Efficacy

ERIC Educational Resources Information Center

Flook, Lisa; Goldberg, Simon B.; Pinger, Laura; Bonus, Katherine; Davidson, Richard J.

2013-01-01

Despite the crucial role of teachers in fostering children's academic learning and social-emotional well-being, addressing teacher stress in the classroom remains a significant challenge in education. This study reports results from a randomized controlled pilot trial of a modified Mindfulness-Based Stress Reduction course (mMBSR) adapted…

An Emergency Department Intervention to Increase Parent-Child Tobacco Communication: A Pilot Study

ERIC Educational Resources Information Center

Mahabee-Gittens, E. Melinda; Huang, Bin; Slap, Gail B.; Gordon, Judith S.

2008-01-01

We conducted a randomized trial of parents and their 9- to 16-year-old children to pilot test an emergency department (ED)-based intervention designed to increase parent-child tobacco communication. Intervention group (IG) parents received verbal/written instructions on how to relay anti-tobacco messages to their children; control group (CG)…

Changes in cognitive function in a randomized trial of physical activity: results of the lifestyle interventions and independence for elders pilot study

USDA-ARS?s Scientific Manuscript database

Background. Cognitive impairment is an important contributor to disability. Limited clinical trial evidence exists regarding the impact of physical exercise on cognitive function (CF). We report results of a pilot study to provide estimates of the relative impact of physical activity (PA) on 1-year ...

Providing Home-Based HIV Testing and Counseling for Transgender Youth (Project Moxie): Protocol for a Pilot Randomized Controlled Trial.

PubMed

Stephenson, Rob; Metheny, Nicholas; Sharma, Akshay; Sullivan, Stephen; Riley, Erin

2017-11-28

Transgender and gender nonconforming people experience some of the highest human immunodeficiency virus (HIV) rates in the United States, and experience many structural and behavioral barriers that may limit their engagement in HIV testing, prevention, and care. Evidence suggests that transgender and gender nonconforming youth (TY) are especially vulnerable to acquiring HIV, yet there is little research on TY and few services are targeted towards HIV testing, prevention, and care for this population. Telehealth presents an opportunity to mitigate some structural barriers that TY experience in accessing HIV testing, allowing TY to engage in HIV testing and counseling in a safe and nonjudgmental space of their choosing. Project Moxie is an HIV prevention intervention that pairs the use of HIV self-testing with remote video-based counseling and support from a trained, gender-affirming counselor. This study aims to offer a more positive HIV testing and counseling experience, with the goal of improving HIV testing frequency. Project Moxie involves a pilot randomized controlled trial (RCT) of 200 TY aged 15-24 years, who are randomized on a 1:1 basis to control or intervention arms. The aim is to examine whether the addition of counseling provided via telehealth, coupled with home-based HIV testing, can create gains in routine HIV testing among TY over a six-month follow-up period. This study implements a prospective pilot RCT of 200 TY recruited online. Participants in the control arm will receive one HIV self-testing kit and will be asked to report their results via the study's website. Participants in the experimental arm will receive one HIV self-testing kit and will test with a remotely-located counselor during a prescheduled video-counseling session. Participants are assessed at baseline, and at three and six months posttesting. Project Moxie was launched in June 2017 and recruitment is ongoing. As of August 21, 2017, the study had enrolled 130 eligible participants. Combining home-based HIV testing and video-based counseling allows TY, an often stigmatized and marginalized population, to test for HIV in a safe and nonjudgmental setting of their choosing. This approach creates an opportunity to reduce the high rate of HIV among TY through engagement in care, support, and linkage to the HIV treatment cascade for those who test positive. ClinicalTrials.gov NCT03185975; https://clinicaltrials.gov/ct2/show/NCT03185975 (Archived by WebCite at http://www.webcitation.org/6vIjHJ93s). ©Rob Stephenson, Nicholas Metheny, Akshay Sharma, Stephen Sullivan, Erin Riley. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 28.11.2017.

AN INTERVENTION TO ASSIST MEN WHO HAVE SEX WITH MEN DISCLOSE THEIR SEROSTATUS TO CASUAL SEX PARTNERS

PubMed Central

Serovich, Julianne M.; Reed, Sandra; Grafsky, Erika L.; Andrist, David

2009-01-01

This article reports pilot data from a newly developed disclosure intervention and associated measures specifically tailored for disclosure to casual sexual partners. Treatment consisted of a four-session, theoretically driven intervention focusing on the costs and benefits of disclosure. Using a randomized control, crossover design 77 men were randomized into one of three conditions (wait-list control, facilitator only, and computer and facilitator). Results of the study suggest that facilitated administration of the pilot intervention was effective in reducing mean scores on the HIV disclosure behavior and attitude scales and that these reductions were both statistically and practically significant. PMID:19519236

Processing speed and working memory training in multiple sclerosis: a double-blind randomized controlled pilot study.

PubMed

Hancock, Laura M; Bruce, Jared M; Bruce, Amanda S; Lynch, Sharon G

2015-01-01

Between 40-65% of multiple sclerosis patients experience cognitive deficits, with processing speed and working memory most commonly affected. This pilot study investigated the effect of computerized cognitive training focused on improving processing speed and working memory. Participants were randomized into either an active or a sham training group and engaged in six weeks of training. The active training group improved on a measure of processing speed and attention following cognitive training, and data trended toward significance on measures of other domains. Results provide preliminary evidence that cognitive training with multiple sclerosis patients may produce moderate improvement in select areas of cognitive functioning.

A Pilot Randomized Trial of Text-Messaging for Symptom Awareness and Diabetes Knowledge in Adolescents With Type 1 Diabetes

PubMed Central

Han, Yi; Faulkner, Melissa Spezia; Fritz, Heather; Fadoju, Doris; Muir, Andrew; Abowd, Gregory D.; Head, Lauren; Arriaga, Rosa I.

2015-01-01

Adolescents with type 1 diabetes typically receive clinical care every 3 months. Between visits, diabetes-related issues may not be frequently reflected, learned, and documented by the patients, limiting their self-awareness and knowledge about their condition. We designed a text-messaging system to help resolve this problem. In a pilot, randomized controlled trial with 30 adolescents, we examined the effect of text messages about symptom awareness and diabetes knowledge on glucose control and quality of life. The intervention group that received more text messages between visits had significant improvements in quality of life. PMID:25720675

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.

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

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.

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

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.

Does Combat Hearing Preservation Equipment Affect Balance?

PubMed

Ambrosio, Art; Hoffer, Ali N; Hoffer, Michael

2017-03-01

(1) To investigate whether the occlusion effect and hearing attenuation produced by 3M Combat Arms Ear Plugs (CAEP) affects balance when compared to no hearing protection and (2) to investigate whether the occlusion effect and noise-canceling capabilities of the Nacre QuietPro system affects balance when compared to no hearing protection. This prospective study collected pilot data for investigation of mechanisms of balance. 20 subjects with normal hearing and no vestibular dysfunction were tested with blackened goggles in three conditions-no hearing protection, CAEP, and with the Nacre QuietPro. A static posturogrpahy forceplate was used to measure center of gravity angular acceleration for a period of 20 seconds. The order of the conditions tested was randomized for each individual. Mean angular acceleration and standard deviation (degrees/second) of the three conditions were: (1) no hearing protection (control), 0.65 + 0.19, (2) CAEP, 0.69 + 0.23, and (3) QuietPro, 0.70 + 0.20 (one-way analysis of variance [ANOVA], df = 2, F = 0.38, p = 0.706). The components of an intact balance system include a variety of neural inputs, to include vesitbuloocular, vestibulospinal, and labyrinthine afferents. Both the CAEP and Nacre QuietPro are hearing preservation devices utilized during Operation Iraqi Freedom and Operation Enduring Freedom in Afghanistan. Our pilot data show no decrement in balance with utilization of these combat hearing preservation devices. Reprint & Copyright © 2017 Association of Military Surgeons of the U.S.

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

Wong, Philip; Leppert, Ilana R; Roberge, David; Boudam, Karim; Brown, Paul D; Muanza, Thierry; Pike, G Bruce; Chankowsky, Jeffrey; Mihalcioiu, Catalin

2016-08-09

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). 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. 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. DCE-MRI can detect vascular damage secondary to WBRT. Our data suggests that memantine reduces WBRT-induced brain vasculature damages.

Training Parents of Youth with Autism Spectrum Disorder to Advocate for Adult Disability Services: Results from a Pilot Randomized Controlled Trial

PubMed Central

Taylor, Julie Lounds; Hodapp, Robert M.; Burke, Meghan M.; Waitz-Kudla, Sydney N.; Rabideau, Carol

2017-01-01

This study presents findings from a pilot randomized controlled trial, testing a 12-week intervention to train parents of youth with autism spectrum disorder (ASD) to advocate for adult disability services—the Volunteer Advocacy Project-Transition (VAP-T). Participants included 41 parents of youth with ASD within two years of high school exit, randomly assigned to a treatment (N = 20) or wait-list control (N = 21) group. Outcomes, collected before and after the intervention, included parental knowledge about adult services, advocacy skills-comfort, and empowerment. The VAP-T had acceptable feasibility, treatment fidelity, and acceptability. After participating in the VAP-T, intervention parents (compared to controls) knew more about the adult service system, were more skilled/comfortable advocating, and felt more empowered. PMID:28070786

Design and patient characteristics of ESHOL study, a Catalonian prospective randomized study.

PubMed

Maduell, Francisco; Moreso, Francesc; Pons, Mercedes; Ramos, Rosa; Mora-Macià, Josep; Foraster, Andreu; Soler, Jordi; Galceran, Josep M; Martinez-Castelao, Alberto

2011-01-01

Retrospective studies showed that online hemodiafiltration (OL-HDF) is associated with a risk reduction of mortality over standard hemodialysis (HD) in patients with end-stage renal disease. Until now, no information was available from prospective randomized clinical trials. A prospective, randomized, multicenter, open study was designed to be conducted in HD units from Catalonia (Spain). The aim of the study is to compare 3-year survival in prevalent end-stage renal disease patients randomized to OL-HDF or to continue on standard HD. The minimum sample size was calculated according to Catalonian mortality of patients on dialysis and assuming a risk reduction associated with OL-HDF of 35% (1-sided p<0.05 and a statistical power of 0.8) and a rate of dropout due to renal transplantation or loss to follow-up of 30%. From May 2007 to September 2008, 906 patients were included and randomized to OL-HDF (n=456) or standard HD (n=450). Demographics and analytical data at the time of randomization were not different between both groups of patients. Patients will be followed during a 3-year period. The present study will contribute to evaluating the benefit for patient survival of OL-HDF over standard HD.

A Randomized Controlled Pilot Trial of Oral N-Acetylcysteine in Children with Autism

PubMed Central

Hardan, Antonio Y.; Fung, Lawrence K.; Libove, Robin A.; Obukhanych, Tetyana V.; Nair, Surekha; Herzenberg, Leonore A.; Frazier, Thomas W.; Tirouvanziam, Rabindra

2016-01-01

Background An imbalance in the excitatory/inhibitory systems with abnormalities in the glutamatergic pathways has been implicated in the pathophysiology of autism. Furthermore, chronic redox imbalance was also recently linked to this disorder. The goal of this pilot study was to assess the feasibility of using oral N-acetylcysteine (NAC), a glutamatergic modulator and an antioxidant in the treatment of behavioral disturbance in children with autism. Methods This is a 12-week, double-blind, randomized, placebo-controlled study of NAC in children with autistic disorder. Subjects randomized to NAC were initiated at 900 mg daily for 4 weeks, then 900 mg twice-daily for 4 weeks and 900 mg three-times-daily for 4 weeks. The primary behavioral measure (Aberrant Behavior Checklist – Irritability subscale) and safety measures were performed at baseline, 4, 8, and 12 weeks. Secondary measures included the ABC-Stereotypy subscale, Repetitive Behavior Scale – Revised (RBS-R), and Social Responsiveness Scale (SRS). Results Thirty-three subjects (31 males, 2 females; aged 3.2–10.7 years) were randomized in the study. Follow-up data was available on fourteen subjects in the NAC group and fifteen in the placebo group. Oral NAC was well-tolerated with limited side effects. Compared to placebo, NAC resulted in significant improvements on ABC-Irritability subscale (F=6.80; p<.001; d=.96). Conclusions Data from this pilot investigation support the potential usefulness of NAC for treating irritability in children with autistic disorder. Large randomized controlled investigations are warranted. ClinicalTrials.gov Identifier NCT00627705 PMID:22342106

Online CBT life skills programme for low mood and anxiety: study protocol for a pilot randomized controlled trial.

PubMed

Williams, Christopher; McClay, Carrie-Anne; Martinez, Rebeca; Morrison, Jill; Haig, Caroline; Jones, Ray; Farrand, Paul

2016-04-27

Low mood is a common mental health problem with significant health consequences. Studies have shown that cognitive behavioural therapy (CBT) is an effective treatment for low mood and anxiety when delivered one-to-one by an expert practitioner. However, access to this talking therapy is often limited and waiting lists can be long, although a range of low-intensity interventions that can increase access to services are available. These include guided self-help materials delivered via books, classes and online packages. This project aims to pilot a randomized controlled trial of an online CBT-based life skills course with community-based individuals experiencing low mood and anxiety. Individuals with elevated symptoms of depression will be recruited directly from the community via online and newspaper advertisements. Participants will be remotely randomized to receive either immediate access or delayed access to the Living Life to the Full guided online CBT-based life skills package, with telephone or email support provided whilst they use the online intervention. The primary end point will be at 3 months post-randomization, at which point the delayed-access group will be offered the intervention. Levels of depression, anxiety, social functioning and satisfaction will be assessed. This pilot study will test the trial design, and ability to recruit and deliver the intervention. Drop-out rates will be assessed and the completion and acceptability of the package will be investigated. The study will also inform a sample size power calculation for a subsequent substantive randomized controlled trial. ISRCTN ISRCTN12890709.

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.

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

PubMed Central

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

2016-01-01

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

Non-invasive high-intensity focused ultrasound for UV-induced hyperpigmentation in Fitzpatrick skin types III and IV: a prospective, randomized, controlled, evaluator-blinded trial.

PubMed

Vachiramon, Vasanop; Jurairattanaporn, Natthachat; Harnchoowong, Sarawin; Chayavichitsilp, Pamela

2018-02-01

Skin hyperpigmentation is a frequently encountered problem, particularly in darker skin types. Unfortunately, standard treatments for this condition have shown disappointing results. High-intensity focused ultrasound (HIFU) is commonly indicated for skin laxity, but recently was used to treat UV-induced hyperpigmentation in animal models. This study is aimed to evaluate the efficacy and safety of high-intensity focused ultrasound for UVB-induced hyperpigmentation in human subjects. A randomized, evaluator-blinded pilot study was conducted on 20 subjects. Each subject was induced three hyperpigmentary spots by local broadband UVB. After 2 weeks, each spot was randomly allocated to control, low-energy, and high-energy HIFU. Subjects were instructed to follow up weekly for a duration of 1 month. Lightness index measurements, mean improvement scores, subjects' satisfaction, pain scores, and side effects were evaluated. All 20 subjects completed the study. Fourteen subjects had Fitzpatrick (FPT) skin type III and six subjects had FPT skin type IV. Twelve subjects showed greater improvement at control sites while eight subjects showed greater improvement at HIFU-treated sites. In FPT skin type III, HIFU appeared to be inferior to control in both lightness index and mean improvement scores, but in FPT skin type IV, HIFU had greater lightness index improvement and higher improvement scores than control. Side effects were more frequent in high-energy-treated areas. Focused ultrasound may be offered in some patients with hyperpigmentary conditions. More research is needed to determine proper energy settings for optimal outcome.

Using simulation pedagogy to teach clinical education skills: A randomized trial.

PubMed

Holdsworth, Clare; Skinner, Elizabeth H; Delany, Clare M

2016-05-01

Supervision of students is a key role of senior physiotherapy clinicians in teaching hospitals. The objective of this study was to test the effect of simulated learning environments (SLE) on educators' self-efficacy in student supervision skills. A pilot prospective randomized controlled trial with concealed allocation was conducted. Clinical educators were randomized to intervention (SLE) or control groups. SLE participants completed two 3-hour workshops, which included simulated clinical teaching scenarios, and facilitated debrief. Standard Education (StEd) participants completed two online learning modules. Change in educator clinical supervision self-efficacy (SE) and student perceptions of supervisor skill were calculated. Between-group comparisons of SE change scores were analyzed with independent t-tests to account for potential baseline differences in education experience. Eighteen educators (n = 18) were recruited (SLE [n = 10], StEd [n = 8]). Significant improvements in SE change scores were seen in SLE participants compared to control participants in three domains of self-efficacy: (1) talking to students about supervision and learning styles (p = 0.01); (2) adapting teaching styles for students' individual needs (p = 0.02); and (3) identifying strategies for future practice while supervising students (p = 0.02). This is the first study investigating SLE for teaching skills of clinical education. SLE improved educators' self-efficacy in three domains of clinical education. Sample size limited the interpretation of student ratings of educator supervision skills. Future studies using SLE would benefit from future large multicenter trials evaluating its effect on educators' teaching skills, student learning outcomes, and subsequent effects on patient care and health outcomes.

The effect of fluid intake on chronic kidney transplant failure: a pilot study.

PubMed

Magpantay, Laurene; Ziai, Farzad; Oberbauer, Rainer; Haas, Martin

2011-11-01

Transplant recipients are generally instructed to increase their daily fluid intake so as to preserve kidney function. However, studies supporting this hypothesis are lacking. Prospective, randomized study at a tertiary care university hospital. Patients with chronic kidney transplant failure. Assignment to normal fluid intake (NFI: 2 L/day) or high fluid intake (HFI: 4 L/day) for 12 months. The effect of fluid intake on the decrease in estimated glomerular filtration rate (eGFR) was estimated by a mixed-effects general linear model. The analysis was adjusted for the observation period, age, intake of angiotensin-converting enzyme inhibitors or angiotensin II type 1 receptor blockers, diuretics, and transplant duration. A total of 33 patients were randomized to NFI and 29 to HFI. After 12 months, the mean eGFR had decreased to a similar extent in both groups (NFI: 44 ± 9 mL/min vs. 41 ± 9 mL/min; HFI: 46 ± 15 mL/min vs. 44 ± 15 mL/min). In the multivariate analysis, only the observation period had a significant effect on the decrease in eGFR. Randomization to NFI or HFI nor any other variable was associated with kidney function. The association between urine volume and urine osmolality was lost after 12 months. Recommendation of higher fluid intake does not seem to improve chronic kidney transplant failure. However, the lack of association between urine osmolality and reported urine volume at a later stage implies a loss of adherence to fluid intake over time. Copyright © 2011 National Kidney Foundation, Inc. Published by Elsevier Inc. All rights reserved.

Effects of hydration on cognitive function of pilots.

PubMed

Lindseth, Paul D; Lindseth, Glenda N; Petros, Thomas V; Jensen, Warren C; Caspers, Julie

2013-07-01

The objective of this study was to examine the effect of fluid intake and possible dehydration on cognitive flight performance of pilots. A repeated-measures, counterbalanced, mixed study design was used to examine differences in working memory, spatial orientation, and cognitive flight performance of 40 randomly selected healthy pilots after having high and low fluid intakes. Serial weights were also analyzed to determine differences in cognitive flight performance of the dehydrated (1-3% weight loss) and hydrated study participants. Results showed flight performance and spatial cognition test scores were significantly (p < 0.05) poorer for pilots who had low fluid intakes and experienced dehydration in comparison to the hydrated pilots. These findings indicate fluid intake differences resulting in dehydration may have safety implications because peak cognitive performance among pilots is critical for flight safety. Reprint & Copyright © 2013 Association of Military Surgeons of the U.S.

Acceptance and Commitment Therapy Group Treatment for Symptoms of Borderline Personality Disorder: A Public Sector Pilot Study

ERIC Educational Resources Information Center

Morton, Jane; Snowdon, Sharon; Gopold, Michelle; Guymer, Elise

2012-01-01

A pilot study of a brief group-based Acceptance and Commitment Therapy (ACT) intervention (12 two-hour sessions) was conducted with clients of public mental health services meeting four or more criteria for borderline personality disorder (BPD). Participants were randomly assigned to receive the ACT group intervention in addition to their current…

The Influence of Labeling the Vegetable Content of Snack Food on Children's Taste Preferences: A Pilot Study

ERIC Educational Resources Information Center

Pope, Lizzy; Wolf, Randi L.

2012-01-01

Objective: This pilot study examined whether informing children of the presence of vegetables in select snack food items alters taste preference. Methods: A random sample of 68 elementary and middle school children tasted identical pairs of 3 snack food items containing vegetables. In each pair, 1 sample's label included the food's vegetable (eg,…

A Pilot and Feasibility Study of Virtual Reality as a Distraction for Children with Cancer

ERIC Educational Resources Information Center

Gershon, Jonathan; Zimand, Elana; Pickering, Melissa; Rothbaum, Barbara Olasov; Hodges, Larry

2004-01-01

Objective: To pilot and test the feasibility of a novel technology to reduce anxiety and pain associated with an invasive medical procedure in children with cancer. Method: Children with cancer (ages 7-19) whose treatment protocols required access of their subcutaneous venous port device (port access) were randomly assigned to a virtual reality…

Comparison of a Self-Directed and Therapist-Assisted Telehealth Parent-Mediated Intervention for Children with ASD: A Pilot RCT

ERIC Educational Resources Information Center

Ingersoll, Brooke; Wainer, Allison L.; Berger, Natalie I.; Pickard, Katherine E.; Bonter, Nicole

2016-01-01

This pilot RCT compared the effect of a self-directed and therapist-assisted telehealth-based parent-mediated intervention for young children with ASD. Families were randomly assigned to a self-directed or therapist-assisted program. Parents in both groups improved their intervention fidelity, self-efficacy, stress, and positive perceptions of…

Pilot Survey of Young African American Males in Four Cities.

ERIC Educational Resources Information Center

Harris (Louis) and Associates, Inc., New York, NY.

A pilot survey was conducted to explore why some young African American men living in cities stay in high school and why others drop out. Between October 1993 and March 1994, face-to-face interviews were conducted with 360 young black men aged 17 to 22, randomly drawn from census tracts in New York (New York), Chicago (Illinois), Los Angeles…

Preschool Based JASPER Intervention in Minimally Verbal Children with Autism: Pilot RCT

ERIC Educational Resources Information Center

Goods, Kelly Stickles; Ishijima, Eric; Chang, Ya-Chih; Kasari, Connie

2013-01-01

In this pilot study, we tested the effects of a novel intervention (JASPER, Joint Attention Symbolic Play Engagement and Regulation) on 3 to 5 year old, minimally verbal children with autism who were attending a non-public preschool. Participants were randomized to a control group (treatment as usual, 30 h of ABA-based therapy per week) or a…

A Pilot Study of a Culturally Adapted Early Intervention for Young Children with Autism Spectrum Disorders in China

ERIC Educational Resources Information Center

Xu, Yun; Yang, Jian; Yao, Jing; Chen, Jun; Zhuang, Xiangxiang; Wang, Wenxiang; Zhang, Xiaoli; Lee, Gabrielle T.

2018-01-01

The purpose of this study was to pilot test the effects of a culturally adapted early intervention influenced by the Early Start Denver Model (ESDM) on reduction of autism symptoms and severity categorization for young children with autism spectrum disorders in China. Participants were randomly assigned to either the control or intervention…

Pilot Trial of a Disclosure Intervention for HIV+ Mothers: The TRACK Program

ERIC Educational Resources Information Center

Murphy, Debra A.; Armistead, Lisa; Marelich, William D.; Payne, Diana L.; Herbeck, Diane M.

2011-01-01

Objective: The "T"eaching, "R"aising, "A"nd "C"ommunicating with "K"ids (TRACK) program was a longitudinal pilot-trial intervention designed to assist mothers living with HIV (MLHs) to disclose their serostatus to their young children (age 6-12 years). Method: MLH and child dyads (N = 80 dyads) were recruited and randomized to intervention or…

A Pilot Randomized Controlled Trial of DIR/Floortime[TM] Parent Training Intervention for Pre-School Children with Autistic Spectrum Disorders

ERIC Educational Resources Information Center

Pajareya, Kingkaew; Nopmaneejumruslers, Kaewta

2011-01-01

This pilot study was designed to test the efficacy of adding home-based Developmental, Individual-Difference, Relationship-Based (DIR)/Floortime[TM] intervention to the routine care of preschool children with autistic spectrum disorder. Measures of functional emotional development and symptom severity were taken. It was found that after the…

Transitioning the GED[R] Mathematics Test to Computer with and without Accommodations: A Pilot Project

ERIC Educational Resources Information Center

Patterson, Margaret Becker; Higgins, Jennifer; Bozman, Martha; Katz, Michael

2011-01-01

We conducted a pilot study to see how the GED Mathematics Test could be administered on computer with embedded accessibility tools. We examined test scores and test-taker experience. Nineteen GED test centers across five states and 216 randomly assigned GED Tests candidates participated in the project. GED candidates completed two GED mathematics…

A Pilot Study of a Kindergarten Summer School Reading Program in High-Poverty Urban Schools

ERIC Educational Resources Information Center

Denton, Carolyn A.; Solari, Emily J.; Ciancio, Dennis J.; Hecht, Steven A.; Swank, Paul R.

2010-01-01

This pilot study examined an implementation of a kindergarten summer school reading program in 4 high-poverty urban schools. The program targeted both basic reading skills and oral language development. Students were randomly assigned to a treatment group (n = 25) or a typical practice comparison group (n = 28) within each school; however,…

A pilot randomized trial of two cognitive rehabilitation interventions for mild cognitive impairment: caregiver outcomes.

PubMed

Cuc, Andrea V; Locke, Dona E C; Duncan, Noah; Fields, Julie A; Snyder, Charlene Hoffman; Hanna, Sherrie; Lunde, Angela; Smith, Glenn E; Chandler, Melanie

2017-12-01

This study aims to provide effect size estimates of the impact of two cognitive rehabilitation interventions provided to patients with mild cognitive impairment: computerized brain fitness exercise and memory support system on support partners' outcomes of depression, anxiety, quality of life, and partner burden. A randomized controlled pilot trial was performed. At 6 months, the partners from both treatment groups showed stable to improved depression scores, while partners in an untreated control group showed worsening depression over 6 months. There were no statistically significant differences on anxiety, quality of life, or burden outcomes in this small pilot trial; however, effect sizes were moderate, suggesting that the sample sizes in this pilot study were not adequate to detect statistical significance. Either form of cognitive rehabilitation may help partners' mood, compared with providing no treatment. However, effect size estimates related to other partner outcomes (i.e., burden, quality of life, and anxiety) suggest that follow-up efficacy trials will need sample sizes of at least 30-100 people per group to accurately determine significance. Copyright © 2017 John Wiley & Sons, Ltd. Copyright © 2017 John Wiley & Sons, Ltd.

Divalproex Sodium for the Treatment of PTSD and Conduct Disordered Youth: A Pilot Randomized Controlled Clinical Trial

ERIC Educational Resources Information Center

Steiner, Hans; Saxena, Kirti S.; Carrion, Victor; Khanzode, Leena A.; Silverman, Melissa; Chang, Kiki

2007-01-01

We examined the efficacy of divalproex sodium (DVP) for the treatment of PTSD in conduct disorder, utilizing a previous study in which 71 youth were enrolled in a randomized controlled clinical trial. Twelve had PTSD. Subjects (all males, mean age 16, SD 1.0) were randomized into high and low dose conditions. Clinical Global Impression (CGI)…

Relaxation Therapy and Anxiety, Self-Esteem, and Emotional Regulation among Adults with Intellectual Disabilities: A Randomized Controlled Trial

ERIC Educational Resources Information Center

Bouvet, Cyrille; Coulet, Aurélie

2016-01-01

This pilot study is a randomized controlled trial on the effects of relaxation on anxiety, self-esteem, and emotional regulation in adults with intellectual disabilities (ID) working in a center of supported employment in France. We studied 30 adults with mild or moderate ID who were split at random into a relaxation group (RG, 15 subjects), who…

Prospective Randomized Trial of the Military Anti-Shock Garment

DTIC Science & Technology

1987-12-20

No prospective, controlled, randomized studies of !.’AST use were available in the scientific literature. Numerous --ports of MAST use were available...in the scientific literature. ,umerous reports of MAST causing compartment syndromes and amputations did appear in the literature. Beginning in 1983...research funding, computerization of these work sheets became possible, making analysis possible. In that no definitive or scientific clinically controlled

Dietary Effects on Cognition and Pilots’ Flight Performance

PubMed Central

Lindseth, Glenda N.; Lindseth, Paul D.; Jensen, Warren C.; Petros, Thomas V.; Helland, Brian D.; Fossum, Debra L.

2017-01-01

The purpose of this study was to investigate the effects of diet on cognition and flight performance of 45 pilots. Based on a theory of self-care, this clinical study used a repeated-measure, counterbalanced crossover design. Pilots were randomly rotated through 4-day high-carbohydrate, high-protein, high-fat, and control diets. Cognitive flight performance was evaluated using a GAT-2 full-motion flight simulator. The Sternberg short-term memory test and Vandenberg’s mental rotation test were used to validate cognitive flight test results. Pilots consuming a high-protein diet had significantly poorer (p < .05) overall flight performance scores than pilots consuming high-fat and high-carbohydrate diets. PMID:29353985

Efficacy of cognitive behavioural therapy for sleep improvement in patients with persistent delusions and hallucinations (BEST): a prospective, assessor-blind, randomised controlled pilot trial

PubMed Central

Freeman, Daniel; Waite, Felicity; Startup, Helen; Myers, Elissa; Lister, Rachel; McInerney, Josephine; Harvey, Allison G; Geddes, John; Zaiwalla, Zenobia; Luengo-Fernandez, Ramon; Foster, Russell; Clifton, Lei; Yu, Ly-Mee

2015-01-01

Summary Background Sleep disturbance occurs in most patients with delusions or hallucinations and should be treated as a clinical problem in its own right. However, cognitive behavioural therapy (CBT)—the best evidence-based treatment for insomnia—has not been tested in this patient population. We aimed to pilot procedures for a randomised trial testing CBT for sleep problems in patients with current psychotic experiences, and to provide a preliminary assessment of potential benefit. Methods We did this prospective, assessor-blind, randomised controlled pilot trial (Better Sleep Trial [BEST]) at two mental health centres in the UK. Patients (aged 18–65 years) with persistent distressing delusions or hallucinations in the context of insomnia and a schizophrenia spectrum diagnosis were randomly assigned (1:1), via a web-based randomisation system with minimisation to balance for sex, insomnia severity, and psychotic experiences, to receive either eight sessions of CBT plus standard care (medication and contact with the local clinical team) or standard care alone. Research assessors were masked to group allocation. Assessment of outcome was done at weeks 0, 12 (post-treatment), and 24 (follow-up). The primary efficacy outcomes were insomnia assessed by the Insomnia Severity Index (ISI) and delusions and hallucinations assessed by the Psychotic Symptoms Rating Scale (PSYRATS) at week 12. We did analysis by intention to treat, with an aim to provide confidence interval estimation of treatment effects. This study is registered with ISRCTN, number 33695128. Findings Between Dec 14, 2012, and May 22, 2013, and Nov 7, 2013, and Aug 26, 2014, we randomly assigned 50 patients to receive CBT plus standard care (n=24) or standard care alone (n=26). The last assessments were completed on Feb 10, 2015. 48 (96%) patients provided follow-up data. 23 (96%) patients offered CBT took up the intervention. Compared with standard care, CBT led to reductions in insomnia in the large effect size range at week 12 (adjusted mean difference 6·1, 95% CI 3·0–9·2, effect size d=1·9). By week 12, nine (41%) of 22 patients receiving CBT and one (4%) of 25 patients receiving standard care alone no longer had insomnia, with ISI scores lower than the cutoff for insomnia. The treatment effect estimation for CBT covered a range from reducing but also increasing delusions (adjusted mean difference 0·3, 95% CI −2·0 to 2·6) and hallucinations (−1·9, −6·5 to 2·7). Three patients, all in the CBT group, had five adverse events, although none were regarded as related to study treatment. Interpretation Our findings show that CBT for insomnia might be highly effective for improving sleep in patients with persistent delusions or hallucinations. A larger, suitably powered phase 3 study is now needed to provide a precise estimate of the effects of CBT for sleep problems, both on sleep and psychotic experiences. Funding Research for Patient Benefit Programme, National Institute for Health Research. PMID:26363701

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.

Rebamipide May Be Comparable to H2 Receptor Antagonist in Healing Iatrogenic Gastric Ulcers Created by Endoscopic Mucosal Resection: A Prospective Randomized Pilot Study

PubMed Central

Kim, Yu Jin; Lee, Sang Kil; Kim, Jie Hyun; Lee, Yong Chan

2010-01-01

Endoscopic mucosal resection (EMR) results in the formation of iatrogenic gastric ulcers and the optimal treatments for such ulcers are still unclear. We aimed to evaluate the efficacy of rebamipide in the management of EMR-induced ulcers by comparing it with an H2 receptor antagonist. After EMR, patients were randomly assigned into either rebamipide or famotidine groups. All patients received a one-week lansoprazole 30 mg q.d. therapy followed by three-week famotidine (20 mg b.i.d.) or rebamipide (100 mg t.i.d.) therapy. Four weeks after the treatments, ulcer sizes, stages, bleeding rates, and ulcer-related symptoms were compared using endoscopy and a questionnaire. A total of 63 patients were enrolled in this study. Finally, 51 patients were analyzed, 26 in rebamipide and 25 in famotidine group. Baseline characteristics were not significantly different between the two groups. Four weeks after EMR, the two groups were comparable in terms of ulcer reduction ratio (P=0.297), and ulcer stage (P=1.000). Moreover, no difference was observed with regard to ulcer-related symptoms, drug compliance, adverse drug event rates, and bleeding rates. Our data suggest that rebamipide is not inferior to famotidine in healing iatrogenic gastric ulcers, and could be a therapeutic option in the treatment of such ulcers. PMID:20358002

Ultrasound-guided Combined Fascial Plane Blocks as an Intervention for Pain Management after Laparoscopic Cholecystectomy: A Randomized Control Study

PubMed Central

Ramkiran, Seshadri; Jacob, Mathews; Honwad, Manish; Vivekanand, Desiraju; Krishnakumar, Mathangi; Patrikar, Seema

2018-01-01

Background: Pain associated with laparoscopic cholecystectomy is most severe during the first 24 h and the port sites are the most painful. Recent multimodal approaches target incisional pain instead of visceral pain which has led to the emergence of abdominal fascial plane blocks. This study embraces a novel combination of two independently effective fascial plane blocks, namely rectus sheath block and subcostal transversus abdominis plane (TAP) block to alleviate postoperative pain. Study Objective: The aim is to evaluate the effectiveness of the combination of rectus sheath block and subcostal TAP block, to compare its efficacy with that of subcostal TAP block alone and with conventional port site infiltration (PSI) in alleviating postoperative pain in patients undergoing laparoscopic cholecystectomy. Methodology: This prospective, randomized control, pilot study included 61 patients scheduled for elective laparoscopic cholecystectomy and distributed among three groups, namely Group 1: Combined subcostal TAP block with rectus sheath block (n = 20); Group 2: Oblique subcostal TAP block alone (n = 21); and Group 3: PSI group as an active control (n = 20). Results: Combined group had significantly lower pain scores, higher satisfaction scores, and reduced rescue analgesia both in early and late postoperative periods than the conventional PSI group. Conclusion: Ultrasound-guided combined fascial plane blocks is a novel intervention in pain management of patients undergoing laparoscopic cholecystectomy and should become the standard of care. PMID:29628547

A randomized trial of enema versus polyethylene glycol 3350 for fecal disimpaction in children presenting to an emergency department.

PubMed

Miller, Melissa K; Dowd, Mary Denise; Friesen, Craig A; Walsh-Kelly, Christine M

2012-02-01

This study aimed to compare efficacy of enema versus polyethylene glycol (PEG) 3350 for pediatric fecal impaction treatment. We conducted a prospective, randomized comparison of treatments of fecal impaction in children in a pediatric emergency department (ED). Treatment arms were a single milk and molasses enema in the ED or PEG 3350 for 3 days outpatient. Telephone follow-up was done on days 1, 3, and 5. The primary outcome was main symptom improvement. Additional outcomes were stool frequency, consistency, and ease of stool passage. Treatment failures (home enema, ED return, or hospital admission) were tracked. Seventy-nine subjects participated (39 PEG; 40 enema). At day 1, PEG subjects were less likely to have improved main symptom (odds ratio [OR], 0.3; 95% confidence interval [CI], 0.1-0.8) but no difference in other outcomes. Half (54%) in enema arm were reported as upset by ED therapy, whereas no children in PEG arm were upset (P < 0.05). At day 3, more patients in enema arm reported ideal stool consistency (74% vs 38%; P < 0.05). At day 5, no difference between groups was noted. Most treatment failures were in PEG arm (83%; P = 0.08). This pilot study suggests that disimpaction by enema may be superior to PEG for immediate relief of symptoms. Larger trials are needed to assess any advantage.

A pilot randomized controlled trial of D-cycloserine and distributed practice as adjuvants to constraint-induced movement therapy after stroke.

PubMed

Nadeau, Stephen E; Davis, Sandra E; Wu, Samuel S; Dai, Yunfeng; Richards, Lorie G

2014-01-01

Background. Phase III trials of rehabilitation of paresis after stroke have proven the effectiveness of intensive and extended task practice, but they have also shown that many patients do not qualify, because of severity of impairment, and that many of those who are treated are left with clinically significant deficits. Objective. To test the value of 2 potential adjuvants to normal learning processes engaged in constraint-induced movement therapy (CIMT): greater distribution of treatment over time and the coadministration of d-cycloserine, a competitive agonist at the glycine site of the N-methyl-D-aspartate glutamate receptor. Methods. A prospective randomized single-blind parallel-group trial of more versus less condensed therapy (2 vs 10 weeks) and d-cycloserine (50 mg) each treatment day versus placebo (in a 2 × 2 design), as potential adjuvants to 60 hours of CIMT. Results. Twenty-four participants entered the study, and 22 completed it and were assessed at the completion of treatment and 3 months later. Neither greater distribution of treatment nor treatment with d-cycloserine significantly augmented retention of gains achieved with CIMT. Conclusions. Greater distribution of practice and treatment with d-cycloserine do not appear to augment retention of gains achieved with CIMT. However, concentration of CIMT over 2 weeks ("massed practice") appears to confer no advantage either. © The Author(s) 2014.

Improving care of patients with diabetes and CKD: a pilot study for a cluster-randomized trial.

PubMed

Cortés-Sanabria, Laura; Cabrera-Pivaral, Carlos E; Cueto-Manzano, Alfonso M; Rojas-Campos, Enrique; Barragán, Graciela; Hernández-Anaya, Moisés; Martínez-Ramírez, Héctor R

2008-05-01

Family physicians may have the main role in managing patients with type 2 diabetes mellitus with early nephropathy. It is therefore important to determine the clinical competence of family physicians in preserving renal function of patients. The aim of this study is to evaluate the effect of an educational intervention on family physicians' clinical competence and subsequently determine the impact on kidney function of their patients with type 2 diabetes mellitus. Pilot study for a cluster-randomized trial. Primary health care units of the Mexican Institute of Social Security, Guadalajara, Mexico. The study group was composed of 21 family physicians from 1 unit and a control group of 19 family physicians from another unit. 46 patients treated by study physicians and 48 treated by control physicians also were evaluated. An educative strategy based on a participative model used during 6 months in the study group. Allocation of units to receive or not receive the educative intervention was randomly established. Clinical competence of family physicians and kidney function of patients. To evaluate clinical competence, a validated questionnaire measuring family physicians' capability to identify risk factors, integrate diagnosis, and correctly use laboratory tests and therapeutic resources was applied to all physicians at the beginning and end of educative intervention (0 and 6 months). In patients, serum creatinine level, estimated glomerular filtration rate, and albuminuria were evaluated at 0, 6, and 12 months. At the end of the intervention, more family physicians from the study group improved clinical competence (91%) compared with controls (37%; P = 0.001). Family physicians in the study group who increased their competence improved renal function significantly better than physicians in the same group who did not increase competence and physicians in the control group (with or without increase in competence): change in estimated glomerular filtration rate, 0.9 versus -33, -21, and -16 mL/min/1.73 m(2) (P < 0.05); and change in urinary albumin excretion of -18 versus 226, 142, and 288 mg/d, respectively (P < 0.05). Compared with other groups, study family physicians with clinical competence also controlled systolic blood pressure significantly better and were more likely to increase the use of angiotensin-converting enzyme inhibitors, angiotensin receptor blockers, and statins and to discontinue nonsteroidal anti-inflammatory drugs. Our analysis did not adjust for clustering. Physicians in only 2 units were randomly assigned; thus, it is not possible to distinguish the effect of the intervention from the effect of the unit. Educative intervention to primary physicians is feasible. Our data may be the basis for additional prospective studies with a cluster-randomized trial design and larger numbers of centers, physicians, and patients.

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

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

Pitton, Michael B., E-mail: michael.pitton@unimedizin-mainz.de; Kloeckner, Roman; Ruckes, Christian

PurposeTo prospectively compare SIRT and DEB-TACE for treating hepatocellular carcinoma (HCC).MethodsFrom 04/2010–07/2012, 24 patients with histologically proven unresectable N0, M0 HCCs were randomized 1:1 to receive SIRT or DEB-TACE. SIRT could be repeated once in case of recurrence; while, TACE was repeated every 6 weeks until no viable tumor tissue was detected by MRI or contraindications prohibited further treatment. Patients were followed-up by MRI every 3 months; the final evaluation was 05/2013.ResultsBoth groups were comparable in demographics (SIRT: 8males/4females, mean age 72 ± 7 years; TACE: 10males/2females, mean age 71 ± 9 years), initial tumor load (1 patient ≥25 % in each group), and BCLC (Barcelona Clinic Liver Cancer)more » stage (SIRT: 12×B; TACE 1×A, 11×B). Median progression-free survival (PFS) was 180 days for SIRT versus 216 days for TACE patients (p = 0.6193) with a median TTP of 371 days versus 336 days, respectively (p = 0.5764). Median OS was 592 days for SIRT versus 788 days for TACE patients (p = 0.9271). Seven patients died in each group. Causes of death were liver failure (n = 4 SIRT group), tumor progression (n = 4 TACE group), cardiovascular events, and inconclusive (n = 1 in each group).ConclusionsNo significant differences were found in median PFS, OS, and TTP. The lower rate of tumor progression in the SIRT group was nullified by a greater incidence of liver failure. This pilot study is the first prospective randomized trial comparing SIRT and TACE for treating HCC, and results can be used for sample size calculations of future studies.« less

Using Randomized Controlled Trials to Evaluate Interventions for Releasing Prisoners

ERIC Educational Resources Information Center

Pettus-Davis, Carrie; Howard, Matthew Owen; Dunnigan, Allison; Scheyett, Anna M.; Roberts-Lewis, Amelia

2016-01-01

Randomized controlled trials (RCTs) are rarely used to evaluate social and behavioral interventions designed for releasing prisoners. Objective: We use a pilot RCT of a social support intervention (Support Matters) as a case example to discuss obstacles and strategies for conducting RCT intervention evaluations that span prison and community…

A Pilot Randomized Controlled Trial of the ACCESS Program: A Group Intervention to Improve Social, Adaptive Functioning, Stress Coping, and Self-Determination Outcomes in Young Adults with Autism Spectrum Disorder.

PubMed

Oswald, Tasha M; Winder-Patel, Breanna; Ruder, Steven; Xing, Guibo; Stahmer, Aubyn; Solomon, Marjorie

2018-05-01

The purpose of this pilot randomized controlled trial was to investigate the acceptability and efficacy of the Acquiring Career, Coping, Executive control, Social Skills (ACCESS) Program, a group intervention tailored for young adults with autism spectrum disorder (ASD) to enhance critical skills and beliefs that promote adult functioning, including social and adaptive skills, self-determination skills, and coping self-efficacy. Forty-four adults with ASD (ages 18-38; 13 females) and their caregivers were randomly assigned to treatment or waitlist control. Compared to controls, adults in treatment significantly improved in adaptive and self-determination skills, per caregiver report, and self-reported greater belief in their ability to access social support to cope with stressors. Results provide evidence for the acceptability and efficacy of the ACCESS Program.

The Mothers and Toddlers Program, an attachment-based parenting intervention for substance using women: Post-treatment results from a randomized clinical pilot

PubMed Central

Suchman, Nancy E.; DeCoste, Cindy; Castiglioni, Nicole; McMahon, Thomas J.; Rounsaville, Bruce; Mayes, Linda

2010-01-01

This is a report of post-treatment findings from a completed randomized pilot study testing the preliminary efficacy of The Mothers and Toddlers Program (MTP), a 12 week attachment-based individual parenting therapy for mothers enrolled in substance abuse treatment and caring for children ages birth to 36 months. Forty-seven mothers were randomized to MTP versus the Parent Education Program (PE) – a comparison intervention providing individual case management and child guidance brochures. At post-treatment, MTP mothers demonstrated better reflective functioning in the Parent Development Interview, representational coherence and sensitivity, and caregiving behavior than PE mothers. Partial support was also found for proposed mechanisms of change in the MTP model. Together, preliminary findings suggest that attachment-based interventions may be more effective than traditional parent training for enhancing relationships between substance using women and their young children. PMID:20730641

Pilot study of the Korean Parent Training Program using a partial group randomized experimental study

PubMed Central

Kim, Eunjung; Cain, Kevin; Boutain, Doris; Chun, Jin-Joo; Kim, Sangho; Im, Hyesang

2017-01-01

Problems Korean American (KA) children experience mental health problems due to difficulties in parenting dysfunction complicated by living in two cultures. Methods Korean Parent Training Program (KPTP) was pilot tested with 48 KA mothers of children (ages 3–8) using partial group randomized controlled experimental study design. Self-report survey and observation data were gathered. Findings Analyses using generalized estimating equation indicated the intervention group mothers increased effective parenting and their children decreased behavior problems and reported less acculturation conflict with mothers. Conclusions The KPTP is a promising way to promote effective parenting and increase positive child mental health in KA families. PMID:24645901

Innovative dressing and securement of tunneled central venous access devices in pediatrics: a pilot randomized controlled trial.

PubMed

Ullman, Amanda J; Kleidon, Tricia; Gibson, Victoria; McBride, Craig A; Mihala, Gabor; Cooke, Marie; Rickard, Claire M

2017-08-30

Central venous access device (CVAD) associated complications are a preventable source of patient harm, frequently resulting in morbidity and delays to vital treatment. Dressing and securement products are used to prevent infectious and mechanical complications, however current complication rates suggest customary practices are inadequate. The aim of this study was to evaluate the feasibility of launching a full-scale randomized controlled efficacy trial of innovative dressing and securement products for pediatric tunneled CVAD to prevent complication and failure. An external, pilot, four-group randomized controlled trial of standard care (bordered polyurethane dressing and suture), in comparison to integrated securement-dressing, suture-less securement device, and tissue adhesive was undertaken across two large, tertiary referral pediatric hospitals in Australia. Forty-eight pediatric participants with newly inserted tunneled CVADs were consecutively recruited. The primary outcome of study feasibility was established by elements of eligibility, recruitment, attrition, protocol adherence, missing data, parent and healthcare staff satisfaction and acceptability, and effect size estimates for CVAD failure (cessation of function prior to completion of treatment) and complication (associated bloodstream infection, thrombosis, breakage, dislodgement or occlusion). Dressing integrity, product costs and site complications were also examined. Protocol feasibility was established. CVAD failure was: 17% (2/12) integrated securement-dressing; 8% (1/13) suture-less securement device; 0% tissue adhesive (0/12); and, 0% standard care (0/11). CVAD complications were: 15% (2/13) suture-less securement device (CVAD associated bloodstream infection, and occlusion and partial dislodgement); 8% (1/12) integrated securement-dressing (partial dislodgement); 0% tissue adhesive (0/12); and, 0% standard care (0/11). One CVAD-associated bloodstream infection occurred, within the suture-less securement device group. Overall satisfaction was highest in the integrated securement-dressing (mean 8.5/10; standard deviation 1.2). Improved dressing integrity was evident in the intervention arms, with the integrated securement-dressing associated with prolonged time to first dressing change (mean days 3.5). Improving the security and dressing integrity of tunneled CVADs is likely to improve outcomes for pediatric patients. Further research is necessary to identify novel, effective CVAD securement to reduce complications, and provide reliable vascular access for children. ACTRN12614000280606 ; prospectively registered on 17/03/2014.

Selection of single blastocysts for fresh transfer via standard morphology assessment alone and with array CGH for good prognosis IVF patients: results from a randomized pilot study

PubMed Central

2012-01-01

Background Single embryo transfer (SET) remains underutilized as a strategy to reduce multiple gestation risk in IVF, and its overall lower pregnancy rate underscores the need for improved techniques to select one embryo for fresh transfer. This study explored use of comprehensive chromosomal screening by array CGH (aCGH) to provide this advantage and improve pregnancy rate from SET. Methods First-time IVF patients with a good prognosis (age <35, no prior miscarriage) and normal karyotype seeking elective SET were prospectively randomized into two groups: In Group A, embryos were selected on the basis of morphology and comprehensive chromosomal screening via aCGH (from d5 trophectoderm biopsy) while Group B embryos were assessed by morphology only. All patients had a single fresh blastocyst transferred on d6. Laboratory parameters and clinical pregnancy rates were compared between the two groups. Results For patients in Group A (n = 55), 425 blastocysts were biopsied and analyzed via aCGH (7.7 blastocysts/patient). Aneuploidy was detected in 191/425 (44.9%) of blastocysts in this group. For patients in Group B (n = 48), 389 blastocysts were microscopically examined (8.1 blastocysts/patient). Clinical pregnancy rate was significantly higher in the morphology + aCGH group compared to the morphology-only group (70.9 and 45.8%, respectively; p = 0.017); ongoing pregnancy rate for Groups A and B were 69.1 vs. 41.7%, respectively (p = 0.009). There were no twin pregnancies. Conclusion Although aCGH followed by frozen embryo transfer has been used to screen at risk embryos (e.g., known parental chromosomal translocation or history of recurrent pregnancy loss), this is the first description of aCGH fully integrated with a clinical IVF program to select single blastocysts for fresh SET in good prognosis patients. The observed aneuploidy rate (44.9%) among biopsied blastocysts highlights the inherent imprecision of SET when conventional morphology is used alone. Embryos randomized to the aCGH group implanted with greater efficiency, resulted in clinical pregnancy more often, and yielded a lower miscarriage rate than those selected without aCGH. Additional studies are needed to verify our pilot data and confirm a role for on-site, rapid aCGH for IVF patients contemplating fresh SET. PMID:22551456

Gaming and Conventional Exercises for Improvement of Arm Function After Stroke: A Randomized Controlled Pilot Study.

PubMed

Kottink, Anke I R; Prange, Gerdienke B; Krabben, Thijs; Rietman, Johan S; Buurke, Jaap H

2014-06-01

The use of new technologies in rehabilitation, such as virtual reality and/or computerized gaming exercises, may be useful to enable patients to practice intensively in a motivating way. The objective of the present randomized controlled pilot study was to compare the effect of reach training using a target group specific-designed rehabilitation game to time-matched standardized conventional reach training on arm function after stroke. Twenty chronic stroke patients were randomized to either the rehabilitation game group or the conventional training group. Both groups received three arm training sessions of 30 minutes each week, during a period of 6 weeks. Arm (the upper extremity part of Fugl-Meyer [FM] assessment) and hand (the Action Research Arm [ARA] test) functions were tested 1 week before (T0) and 1 week after (T1) training. A follow-up measurement was performed at 1 month after T1 (T2). ARA and FM scores improved significantly within both groups. Post hoc comparisons revealed significant increases in test scores between T0 and T1 and between T0 and T2 for both ARA and FM, but not for changes from T1 to T2. There were no significant differences between both groups for either clinical test. The present randomized controlled pilot study showed that both arm and hand function improved as much after training with a rehabilitation game as after time-matched conventional training.

Two Pilot Randomized Trials To Examine Feasibility and Impact of Treated Parents as Peer Interventionists in Family-Based Pediatric Weight Management.

PubMed

Saelens, Brian E; Scholz, Kelley; Walters, Kelly; Simoni, Jane M; Wright, Davene R

2017-08-01

To examine feasibility and initial efficacy of having previously treated parents serve as peer interventionists in family-based behavioral weight management treatment (FBT). Children aged 7-11 years with overweight/obesity and parents (n = 59 families) were enrolled in one of two pilot trials, the EPICH (Engaging Parents in Child Health) randomized trial comparing professional versus peer FBT delivery or the Parent Partnership trial, which provided professionally delivered FBT to families (first generation) and then randomly assigned first generation parents to either be or not be peer interventionists for subsequent families (second generation). Efficacy (child zBMI change), feasibility, and costs for delivering FBT, and impacts of being a peer interventionist were examined. In EPICH, families receiving professional versus peer intervention had similar decreases in child zBMI and parent BMI, with markedly lower costs for peer versus professional delivery. In Parent Partnership, families receiving peer intervention significantly decreased weight status, with very preliminary evidence suggesting better maintenance of child zBMI changes if parents served as peer interventionists. Previously treated parents were willing, highly confident, and able to serve as peer interventionists in FBT. Two pilot randomized clinical trials suggest parents-as-peer interventionists in FBT may be feasible, efficacious, and delivered at lower costs, with perhaps some additional benefits to serving as a peer interventionist. More robust investigation is warranted of peer treatment delivery models for pediatric weight management.

Effects of hyperthermic baths on depression, sleep and heart rate variability in patients with depressive disorder: a randomized clinical pilot trial.

PubMed

Naumann, Johannes; Grebe, Julian; Kaifel, Sonja; Weinert, Tomas; Sadaghiani, Catharina; Huber, Roman

2017-03-28

Despite advances in the treatment of depression, one-third of depressed patients fail to respond to conventional antidepressant medication. There is a need for more effective treatments with fewer side effects. The primary aim of this study was to determine whether hyperthermic baths reduce depressive symptoms in adults with depressive disorder. Randomized, two-arm placebo-controlled, 8-week pilot trial. Medically stable outpatients with confirmed depressive disorder (ICD-10: F32/F33) who were moderately depressed as determined by the 17-item Hamilton Scale for Depression (HAM-D) score ≥18 were randomly assigned to 2 hyperthermic baths (40 °C) per week for 4 weeks or a sham intervention with green light and follow-up after 4 weeks. Main outcome measure was the change in HAM-D total score from baseline (T0) to the 2-week time point (T1). A total of 36 patients were randomized (hyperthermic baths, n = 17; sham condition, n = 19). The intention-to-treat analysis showed a significant (P = .037) difference in the change in HAM-D total score with 3.14 points after 4 interventions (T1) in favour of the hyperthermic bath group compared to the placebo group. This pilot study suggests that hyperthermic baths do have generalized efficacy in depressed patients. DRKS00004803 at drks-neu.uniklinik-freiburg.de, German Clinical Trials Register (registration date 2016-02-02), retrospectively registered.

Methodological challenges in evaluating the effectiveness of women's crisis houses compared with psychiatric wards: findings from a pilot patient preference RCT.

PubMed

Howard, Louise M; Leese, Morven; Byford, Sarah; Killaspy, Helen; Cole, Laura; Lawlor, Caroline; Johnson, Sonia

2009-10-01

There are several methodological difficulties to address when evaluating acute psychiatric services. This study explored potential methods in evaluating the effectiveness of women's crisis houses compared with psychiatric wards in a pilot patient preference randomized controlled trial. Women requiring voluntary admission to a psychiatric hospital or women's crisis house were asked to enter this pilot and different options for recruitment were explored, including different recruitment sites in the pathway to admission and methods for including women without capacity. Forty-one percent (n = 42) of women entering the study agreed to be randomized and 59% (n = 61) entered patient preference arms. Only 7% of women were recruited before admission and 1 woman without capacity entered the study, despite procedures to facilitate this. Recruitment of patients with acute psychiatric crises is therefore challenging; researchers evaluating acute services should establish a consensus on how ethically and practically to recruit patients in this setting.

Lessons learned: a pilot study on occupational therapy effectiveness for children with sensory modulation disorder.

PubMed

Miller, Lucy Jane; Schoen, Sarah A; James, Katherine; Schaaf, Roseann C

2007-01-01

The purpose of this pilot study was to prepare for a randomized controlled study of the effectiveness of occupational therapy using a sensory integration approach (OT-SI) with children who have sensory processing disorders (SPD). A one-group pretest, posttest design with 30 children was completed with a subset of children with SPD, those with sensory modulation disorder. Lessons learned relate to (a) identifying a homogeneous sample with quantifiable inclusion criteria, (b) developing an intervention manual for study replication and a fidelity to treatment measure, (c) determining which outcomes are sensitive to change and relate to parents' priorities, and (d) clarifying rigorous methodologies (e.g., blinded examiners, randomization, power). A comprehensive program of research is needed, including multiple pilot studies to develop enough knowledge that high-quality effectiveness research in occupational therapy can be completed. Previous effectiveness studies in OT-SI have been single projects not based on a unified long-term program of research.

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.

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.

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.

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.

Being "SMART" About Adolescent Conduct Problems Prevention: Executing a SMART Pilot Study in a Juvenile Diversion Agency.

PubMed

August, Gerald J; Piehler, Timothy F; Bloomquist, Michael L

2016-01-01

The development of adaptive treatment strategies (ATS) represents the next step in innovating conduct problems prevention programs within a juvenile diversion context. Toward this goal, we present the theoretical rationale, associated methods, and anticipated challenges for a feasibility pilot study in preparation for implementing a full-scale SMART (i.e., sequential, multiple assignment, randomized trial) for conduct problems prevention. The role of a SMART design in constructing ATS is presented. The SMART feasibility pilot study includes a sample of 100 youth (13-17 years of age) identified by law enforcement as early stage offenders and referred for precourt juvenile diversion programming. Prior data on the sample population detail a high level of ethnic diversity and approximately equal representations of both genders. Within the SMART, youth and their families are first randomly assigned to one of two different brief-type evidence-based prevention programs, featuring parent-focused behavioral management or youth-focused strengths-building components. Youth who do not respond sufficiently to brief first-stage programming will be randomly assigned a second time to either an extended parent- or youth-focused second-stage programming. Measures of proximal intervention response and measures of potential candidate tailoring variables for developing ATS within this sample are detailed. Results of the described pilot study will include information regarding feasibility and acceptability of the SMART design. This information will be used to refine a subsequent full-scale SMART. The use of a SMART to develop ATS for prevention will increase the efficiency and effectiveness of prevention programing for youth with developing conduct problems.

A pilot cluster randomized controlled trial of structured goal-setting following stroke.

PubMed

Taylor, William J; Brown, Melanie; William, Levack; McPherson, Kathryn M; Reed, Kirk; Dean, Sarah G; Weatherall, Mark

2012-04-01

To determine the feasibility, the cluster design effect and the variance and minimal clinical importance difference in the primary outcome in a pilot study of a structured approach to goal-setting. A cluster randomized controlled trial. Inpatient rehabilitation facilities. People who were admitted to inpatient rehabilitation following stroke who had sufficient cognition to engage in structured goal-setting and complete the primary outcome measure. Structured goal elicitation using the Canadian Occupational Performance Measure. Quality of life at 12 weeks using the Schedule for Individualised Quality of Life (SEIQOL-DW), Functional Independence Measure, Short Form 36 and Patient Perception of Rehabilitation (measuring satisfaction with rehabilitation). Assessors were blinded to the intervention. Four rehabilitation services and 41 patients were randomized. We found high values of the intraclass correlation for the outcome measures (ranging from 0.03 to 0.40) and high variance of the SEIQOL-DW (SD 19.6) in relation to the minimally importance difference of 2.1, leading to impractically large sample size requirements for a cluster randomized design. A cluster randomized design is not a practical means of avoiding contamination effects in studies of inpatient rehabilitation goal-setting. Other techniques for coping with contamination effects are necessary.

Contributions of Platform Motion to Simulator Training Effectiveness: Study II--Aerobatics. Interim Report for Period March 1976-November 1977.

ERIC Educational Resources Information Center

Martin, Elizabeth L.; Waag, Wayne L.

A transfer-of-training design was used to evaluate the contributions of simulator training with synergistic six-degrees-of-freedom platform motion to aerobatic skills acquisition in the novice pilot. Thirty-six undergraduate pilot trainees were randomly assigned to one of three treatment groups: motion, no-motion, and control. Those in the control…

A Play and Joint Attention Intervention for Teachers of Young Children with Autism: A Randomized Controlled Pilot Study

ERIC Educational Resources Information Center

Wong, Connie S.

2013-01-01

The aim of this study was to pilot test a classroom-based intervention focused on facilitating play and joint attention for young children with autism in self-contained special education classrooms. Thirty-three children with autism between the ages of 3 and 6 years participated in the study with their classroom teachers (n = 14). The 14 preschool…

The Impact of Life Skills Training on Behavior Problems in Left-Behind Children in Rural China: A Pilot Study

ERIC Educational Resources Information Center

Liu, Jia; Liu, Shan; Yan, Jin; Lee, Elizabeth; Mayes, Linda

2016-01-01

A randomized controlled experimental pilot study was conducted in order to investigate the effect of life skills training on behavior problems in left-behind children (LBC) in rural China. Sixty-eight LBC were recruited from a middle school in rural China. The intervention group took a ten-week-long life skills training course. The Child Behavior…

Comparative Effectiveness of Houghton Mifflin Harcourt Fuse: Algebra 1--A Report of Randomized Experiments in Four California Districts

ERIC Educational Resources Information Center

Toby, Megan; Ma, Boya; Lai, Garrett; Lin, Li; Jaciw, Andrew

2012-01-01

In spring 2010, Houghton Mifflin Harcourt (HMH) began planning a pilot of an application for the Apple iPad, "HMH Fuse: Algebra 1," which was then in development. The application was to be piloted in four California school districts during the 2010-2011 school year. HMH contracted with Empirical Education Inc. to conduct a one-year…

Pilot Testing a Cognitive-Behavioral Protocol on Psychosocial Predictors of Exercise, Nutrition, Weight, and Body Satisfaction Changes in a College-Level Health-Related Fitness Course

ERIC Educational Resources Information Center

Annesi, James J.; Howton, Amy; Johnson, Ping H.; Porter, Kandice J.

2015-01-01

Objective: Small-scale pilot testing of supplementing a required college health-related fitness course with a cognitive-behavioral exercise-support protocol (The Coach Approach). Participants: Three classes were randomly assigned to Usual processes (n = 32), Coach Approach-supplemented: Mid-size Groups (n = 32), and Coach Approach-supplemented:…

A Double-Blind, Placebo-Controlled Study of Risperidone for the Treatment of Adolescents and Young Adults with Anorexia Nervosa: A Pilot Study

ERIC Educational Resources Information Center

Hagman, Jennifer; Gralla, Jane; Sigel, Eric; Ellert, Swan; Dodge, Mindy; Gardner, Rick; O'Lonergan, Teri; Frank, Guido; Wamboldt, Marianne Z.

2011-01-01

Objective: The purpose of this double-blind, placebo-controlled exploratory pilot study was to evaluate the safety and efficacy of risperidone for the treatment of anorexia nervosa. Method: Forty female subjects 12 to 21 years of age (mean, 16 years) with primary anorexia nervosa in an eating disorders program were randomized to receive…

A play and joint attention intervention for teachers of young children with autism: a randomized controlled pilot study.

PubMed

Wong, Connie S

2013-05-01

The aim of this study was to pilot test a classroom-based intervention focused on facilitating play and joint attention for young children with autism in self-contained special education classrooms. Thirty-three children with autism between the ages of 3 and 6 years participated in the study with their classroom teachers (n = 14). The 14 preschool special education teachers were randomly assigned to one of three groups: (1) symbolic play then joint attention intervention, (2) joint attention then symbolic intervention, and (3) wait-list control period then further randomized to either group 1 or group 2. In the intervention, teachers participated in eight weekly individualized 1-h sessions with a researcher that emphasized embedding strategies targeting symbolic play and joint attention into their everyday classroom routines and activities. The main child outcome variables of interest were collected through direct classroom observations. Findings indicate that teachers can implement an intervention to significantly improve joint engagement of young children with autism in their classrooms. Furthermore, multilevel analyses showed significant increases in joint attention and symbolic play skills. Thus, these pilot data emphasize the need for further research and implementation of classroom-based interventions targeting play and joint attention skills for young children with autism.

The Promoting Effective Advance Care for Elders (PEACE) randomized pilot study: theoretical framework and study design.

PubMed

Allen, Kyle R; Hazelett, Susan E; Radwany, Steven; Ertle, Denise; Fosnight, Susan M; Moore, Pamela S

2012-04-01

Practice guidelines are available for hospice and palliative medicine specialists and geriatricians. However, these guidelines do not adequately address the needs of patients who straddle the 2 specialties: homebound chronically ill patients. The purpose of this article is to describe the theoretical basis for the Promoting Effective Advance Care for Elders (PEACE) randomized pilot study. PEACE is an ongoing 2-group randomized pilot study (n=80) to test an in-home interdisciplinary care management intervention that combines palliative care approaches to symptom management, psychosocial and emotional support, and advance care planning with geriatric medicine approaches to optimizing function and addressing polypharmacy. The population comprises new enrollees into PASSPORT, Ohio's community-based, long-term care Medicaid waiver program. All PASSPORT enrollees have geriatric/palliative care crossover needs because they are nursing home eligible. The intervention is based on Wagner's Chronic Care Model and includes comprehensive interdisciplinary care management for these low-income frail elders with chronic illnesses, uses evidence-based protocols, emphasizes patient activation, and integrates with community-based long-term care and other community agencies. Our model, with its standardized, evidence-based medical and psychosocial intervention protocols, will transport easily to other sites that are interested in optimizing outcomes for community-based, chronically ill older adults. © Mary Ann Liebert, Inc.

Child Directed Interaction Training for Young Children in Kinship Care: A Pilot Study

PubMed Central

N’zi, Amanda M.; Stevens, Monica L.; Eyberg, Sheila M.

2016-01-01

This pilot study used a randomized controlled trial design to examine the feasibility and explore initial outcomes of a twice weekly, 8-session Child Directed Interaction Training (CDIT) program for children living in kinship care. Participants included 14 grandmothers and great-grandmothers with their 2- to 7-year-old children randomized either to CDIT or a waitlist control condition. Training was delivered at a local, community library with high fidelity to the training protocol. There was no attrition in either condition. After training, kinship caregivers in the CDIT condition demonstrated more positive relationships with their children during behavioral observation. The caregivers in the CDIT condition also reported clinically and statistically significant decreases in parenting stress and caregiver depression, as well as fewer externalizing child behavior problems than waitlist controls. Parent daily report measures indicated significant changes in disciplining that included greater use of limit-setting and less use of critical verbal force. Results appeared stable at 3-month follow-up. Changes in child internalizing behaviors and caregiver use of non-critical verbal force were not seen until 3-month follow-up. Results of this pilot study suggest both the feasibility of conducting full scale randomized clinical trials of CDIT in the community and the promise of this approach for providing effective parent training for kinship caregivers. PMID:27012997

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.

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

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.

A Prospective Randomized Trial of Two Different Prostate Biopsy Schemes

ClinicalTrials.gov

2016-07-03

Prostate Cancer; Local Anesthesia; Prostate-Specific Antigen/Blood; Biopsy/Methods; Image-guided Biopsy/Methods; Prostatic Neoplasms/Diagnosis; Prostate/Pathology; Prospective Studies; Humans; Male; Ultrasonography, Interventional/Methods

Recruitment methods and costs for a randomized, placebo-controlled trial of chiropractic care for lumbar spinal stenosis: a single-site pilot study.

PubMed

Cambron, Jerrilyn A; Dexheimer, Jennifer M; Chang, Mabel; Cramer, Gregory D

2010-01-01

The purpose of this article is to describe the methods for recruitment in a clinical trial on chiropractic care for lumbar spinal stenosis. This randomized, placebo-controlled pilot study investigated the efficacy of different amounts of total treatment dosage over 6 weeks in 60 volunteer subjects with lumbar spinal stenosis. Subjects were recruited for this study through several media venues, focusing on successful and cost-effective strategies. Included in our efforts were radio advertising, newspaper advertising, direct mail, and various other low-cost initiatives. Of the 1211 telephone screens, 60 responders (5.0%) were randomized into the study. The most successful recruitment method was radio advertising, generating more than 64% of the calls (776 subjects). Newspaper and magazine advertising generated approximately 9% of all calls (108 subjects), and direct mail generated less than 7% (79 subjects). The total direct cost for recruitment was $40 740 or $679 per randomized patient. The costs per randomization were highest for direct mail ($995 per randomization) and lowest for newspaper/magazine advertising ($558 per randomization). Success of recruitment methods may vary based on target population and location. Planning of recruitment efforts is essential to the success of any clinical trial. Copyright 2010 National University of Health Sciences. Published by Mosby, Inc. All rights reserved.

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.

A Parent-Directed Language Intervention for Children of Low Socioeconomic Status: A Randomized Controlled Pilot Study

ERIC Educational Resources Information Center

Suskind, Dana L.; Leffel, Kristin R.; Graf, Eileen; Hernandez, Marc W.; Gunderson, Elizabeth A.; Sapolich, Shannon G.; Suskind, Elizabeth; Leininger, Lindsey; Goldin-Meadow, Susan; Levine, Susan C.

2016-01-01

We designed a parent-directed home-visiting intervention targeting socioeconomic status (SES) disparities in children's early language environments. A randomized controlled trial was used to evaluate whether the intervention improved parents' knowledge of child language development and increased the amount and diversity of parent talk.…

Cognitive Behavioral Principles within Group Mentoring: A Randomized Pilot Study

ERIC Educational Resources Information Center

Jent, Jason F.; Niec, Larissa N.

2009-01-01

This study evaluated the effectiveness of a group mentoring program that included components of empirically supported mentoring and cognitive behavioral techniques for children served at a community mental health center. Eighty-six 8- to 12-year-old children were randomly assigned to either group mentoring or a wait-list control group. Group…

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)…

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...

The Development of an Internet-Based Treatment for Problem Gamblers and Concerned Significant Others: A Pilot Randomized Controlled Trial.

PubMed

Nilsson, Anders; Magnusson, Kristoffer; Carlbring, Per; Andersson, Gerhard; Gumpert, Clara Hellner

2018-06-01

Problem gambling creates significant harm for the gambler and for concerned significant others (CSOs). While several studies have investigated the effects of individual cognitive behavioral therapy (CBT) for problem gambling, less is known about the effects of involving CSOs in treatment. Behavioral couples therapy (BCT) has shown promising results when working with substance use disorders by involving both the user and a CSO. This pilot study investigated BCT for problem gambling, as well as the feasibility of performing a larger scale randomized controlled trial. 36 participants, 18 gamblers and 18 CSOs, were randomized to either BCT or individual CBT for the gambler. Both interventions were Internet-delivered self-help interventions with therapist support. Both groups of gamblers improved on all outcome measures, but there were no differences between the groups. The CSOs in the BCT group lowered their scores on anxiety and depression more than the CSOs of those randomized to the individual CBT group did. The implications of the results and the feasibility of the trial are discussed.

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.

Development and pilot testing of daily Interactive Voice Response (IVR) calls to support antiretroviral adherence in India: A mixed-methods pilot study

PubMed Central

Swendeman, Dallas; Jana, Smarajit; Ray, Protim; Mindry, Deborah; Das, Madhushree; Bhakta, Bhumi

2015-01-01

This two-phase pilot study aimed to design, pilot, and refine an automated Interactive Voice Response (IVR) intervention to support antiretroviral adherence for people living with HIV (PLH), in Kolkata, India. Mixed-methods formative research included a community advisory board (CAB) for IVR message development, one-month pre-post pilot, post-pilot focus groups, and further message development. Two IVR calls are made daily, timed to patients’ dosing schedules, with brief messages (<1-minute) on strategies for self-management of three domains: medical (adherence, symptoms, co-infections), mental health (social support, stress, positive cognitions), and nutrition and hygiene (per PLH preferences). Three ART appointment reminders are also sent each month. One-month pilot results (n=46, 80% women, 60% sex workers) found significant increases in self-reported ART adherence, both within past three days (p=0.05) and time since missed last dose (p=0.015). Depression was common. Messaging content and assessment domains were expanded for testing in a randomized trial is currently underway. PMID:25638037

[The prevalence of snoring in male pilots].

PubMed

Wang, Wan-er; Zhu, Guang-qing; Zhang, Ji-dong; Li, Rong; Wang, Yan-yan; Zhang, Yu-zhen; Liu, Ju-qin; He, Quan-ying

2008-09-01

To investigate and analysis the prevalence and risk factors of snoring and excessive daytime sleepiness among male pilots. 1108 subjects were derived from a random sample of pilots. They were asked to answer the questions from a questionnaire concerning their snoring and daytime sleepiness, etc. 1054 questionnaire were available for evaluation. The overall prevalence of snoring among male pilots was 51.04% (538/1054), while moderate and severe snorers accounted for 26.28% (227/1054). The prevalence of snoring among male pilots aged over 30 yr was 63.68% (426/669). The prevalence and severity of snoring increase with age and BMI. Age, overweight and obesity, alcohol ingestion and family history of snoring were associated with the prevalence and severity of snoring. There was significant difference in Epworth sleepiness scale scores among without snoring group and various severity of snoring groups (chi2 = 16.948, P < 0.05). The prevalence of snoring is high in male pilots. The Epworth sleepiness scale score increase with increasing degree of snoring. Doctors should pay more attention to snoring in male pilot.

Development and Pilot Testing of Daily Interactive Voice Response (IVR) Calls to Support Antiretroviral Adherence in India: A Mixed-Methods Pilot Study.

PubMed

Swendeman, Dallas; Jana, Smarajit; Ray, Protim; Mindry, Deborah; Das, Madhushree; Bhakta, Bhumi

2015-06-01

This two-phase pilot study aimed to design, pilot, and refine an automated interactive voice response (IVR) intervention to support antiretroviral adherence for people living with HIV (PLH), in Kolkata, India. Mixed-methods formative research included a community advisory board for IVR message development, 1-month pre-post pilot, post-pilot focus groups, and further message development. Two IVR calls are made daily, timed to patients' dosing schedules, with brief messages (<1-min) on strategies for self-management of three domains: medical (adherence, symptoms, co-infections), mental health (social support, stress, positive cognitions), and nutrition and hygiene (per PLH preferences). Three ART appointment reminders are also sent each month. One-month pilot results (n = 46, 80 % women, 60 % sex workers) found significant increases in self-reported ART adherence, both within past three days (p = 0.05) and time since missed last dose (p = 0.015). Depression was common. Messaging content and assessment domains were expanded for testing in a randomized trial currently underway.

High Voltage Pulsed Radiofrequency for the Treatment of Refractory Neuralgia of the Infraorbital Nerve: A Prospective Double-Blinded Randomized Controlled Study.

PubMed

Luo, Fang; Wang, Tao; Shen, Ying; Meng, Lan; Lu, Jingjing; Ji, Nan

2017-05-01

A recent study showed that 50% of patients who suffered from refractory neuralgia of the infraorbital nerve obtained satisfactory efficacy after pulsed radiofrequency (PRF) treatment. A pilot study showed that increasing the output voltage of PRF significantly improved the efficacy for trigeminal neuralgia; however, whether increasing the output voltage of PRF can improve the treatment outcomes for neuralgia of the infraorbital nerve is unknown. To evaluate the efficacy and safety of high voltage PRF treatment in comparison with standard voltage PRF for neuralgia of the infraorbital nerve. Prospective, single-center, double-blinded, randomized, controlled trial. Beijing Tiantan Hospital, Capital Medical University. A total of 60 patients with refractory neuralgia of the infraorbital nerve were randomly divided into the high voltage PRF group and the standard voltage PRF group to treat their infraorbital nerves. Neither the patients, pain physicians, nor the follow-up evaluators knew the patient group assignments. The primary outcome measure was the one-year response rate. The secondary outcome measures included the time to take effect after PRF, the one-month, 3-month, and 6-month response rates, the relapse rate, and adverse reactions. The intent-to-treat analysis showed that the one-month, 3-month, 6-month, and one-year response rates were all 90% in the high voltage group, which were significantly higher than the rates in the standard voltage group (67% [P < 0.05], 67% [P < 0.05], 63% [P < 0.05], and 60% [P <0.01], respectively). Furthermore, 27% of the patients in the high-voltage group and 13% of the patients in the standard voltage group experienced minor transient (10 - 30 days) numbness in the innervation area after PRF; no other serious adverse reactions were observed in the 2 groups (P > 0.05). We did not investigate the dose-effect relationship between the output voltage and efficacy or the effect of a higher pulse dose on efficacy. This study was a single-center study, and multi-center, randomized, controlled studies are needed to obtain the highest level of empirical evidence. Additionally, the follow-up period lasted only one year in this study; thus, long-term efficacy needs to be further confirmed. The results showed that high voltage PRF was effective and safe for patients with refractory neuralgia of the infraorbital nerve and could become a treatment option in patients who do not respond to conservative treatment.

Sensory Adapted Dental Environments to Enhance Oral Care for Children with Autism Spectrum Disorders: A Randomized Controlled Pilot Study

ERIC Educational Resources Information Center

Cermak, Sharon A.; Stein Duker, Leah I.; Williams, Marian E.; Dawson, Michael E.; Lane, Christianne J.; Polido, José C.

2015-01-01

This pilot and feasibility study examined the impact of a sensory adapted dental environment (SADE) to reduce distress, sensory discomfort, and perception of pain during oral prophylaxis for children with autism spectrum disorder (ASD). Participants were 44 children ages 6-12 (n = 22 typical, n = 22 ASD). In an experimental crossover design, each…

Parental Influence on Children with Attention-Deficit/Hyperactivity Disorder: II. Results of a Pilot Intervention Training Parents as Friendship Coaches for Children

ERIC Educational Resources Information Center

Mikami, Amori Yee; Lerner, Matthew D.; Griggs, Marissa Swaim; McGrath, Alison; Calhoun, Casey D.

2010-01-01

We report findings from a pilot intervention that trained parents to be "friendship coaches" for their children with Attention-Deficit/Hyperactivity Disorder (ADHD). Parents of 62 children with ADHD (ages 6-10; 68% male) were randomly assigned to receive the parental friendship coaching (PFC) intervention, or to be in a no-treatment control group.…

Treating Anxiety Disorders in Inner City Schools: Results from a Pilot Randomized Controlled Trial Comparing CBT and Usual Care

ERIC Educational Resources Information Center

Ginsburg, Golda S.; Becker, Kimberly D.; Drazdowski, Tess K.; Tein, Jenn-Yun

2012-01-01

Background: The effectiveness of cognitive-behavioral treatment (CBT) in inner city schools, when delivered by novice CBT clinicians, and compared to usual care (UC), is unknown. Objective: This pilot study addressed this issue by comparing a modular CBT for anxiety disorders to UC in a sample of 32 volunteer youth (mean age 10.28 years, 63%…

Comparative Effectiveness of Houghton Mifflin Harcourt Fuse: Algebra 1--A Report of Randomized Experiments in Four California Districts. Research Summary

ERIC Educational Resources Information Center

Empirical Education Inc., 2012

2012-01-01

In spring 2010, Houghton Mifflin Harcourt (HMH) began planning a pilot of an application for the Apple iPad, "HMH Fuse: Algebra 1," which was then in development. The application was to be piloted in four California school districts during the 2010-2011 school year. HMH contracted with Empirical Education Inc. to conduct a one-year…

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.

Cabergoline in the Treatment of Male Orgasmic Disorder—A Retrospective Pilot Analysis

PubMed Central

Hollander, Adam B.; Pastuszak, Alexander W.; Hsieh, Tung-Chin; Johnson, William G.; Scovell, Jason M.; Mai, Christina K.; Lipshultz, Larry I.

2016-01-01

Introduction Male orgasmic disorder is common, with few treatment options. Cabergoline is a dopamine agonist that acts centrally to normalize serum prolactin that could improve orgasmic dysfunction. Aims To determine whether cabergoline increases the potential for orgasm in men with orgasmic disorder. Methods A retrospective chart review of men treated in a single andrology clinic for delayed orgasm or anorgasmia in a pilot study using cabergoline 0.5 mg twice weekly was performed. Duration of treatment and response were noted. Medical records were examined for other factors including history of prostatectomy and concomitant androgen supplementation. Main Outcome Measures Subjective improvement in orgasmic function resulting from cabergoline treatment. Results Of 131 men treated with cabergoline for orgasmic disorder, 87 (66.4%) reported subjective improvement in orgasm and 44 (33.6%) reported no change in orgasm. Duration of therapy (P = .03) and concomitant testosterone therapy (P = .02) were associated with a significant positive response to cabergoline treatment. No differences were found between injectable and non-injectable testosterone formulations (P = .90), and neither age (P = .90) nor prior prostatectomy (P = .41) influenced the outcome of cabergoline treatment. Serum testosterone levels before (P = .26) and after (P = .81) treatment were not significantly different in responders vs non-responders. Conclusion Cabergoline is a potentially effective and easy-to-administer treatment for male orgasmic disorder, the efficacy of which appears to be independent of patient age or orgasmic disorder etiology. Prospective randomized trials are needed to determine the true role of cabergoline in the treatment of this disorder. PMID:26944776

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.

Using virtual reality to control preoperative anxiety in ambulatory surgery patients: A pilot study in maxillofacial and plastic surgery.

PubMed

Ganry, L; Hersant, B; Sidahmed-Mezi, M; Dhonneur, G; Meningaud, J P

2018-01-06

Preoperative anxiety may lead to medical and surgical complications, behavioral problems and emotional distress. The most common means of prevention are based on using medication and, more recently, hypnosis. The aim of our study was to determine whether a virtual reality (VR) program presenting natural scenes could be part of a new therapy to reduce patients' preoperative anxiety. Our prospective pilot study consisted of a single-blind trial in skin cancer surgery at the Henri-Mondor teaching hospital in France. In the outpatient surgery department, 20 patients with a score of >11 on the Amsterdam preoperative anxiety and information scale (APAIS) were virtually immersed into a natural universe for 5minutes. Their stress levels were assessed before and after this experience by making use of a visual analog scale (VAS), by measuring salivary cortisol levels, and by determining physiological stress based on heart coherence scores. The VAS score was significantly reduced after the simulation (P<0.009) as was the level of salivary cortisol (P<0.04). Heart coherence scores remained unchanged (P=0.056). VR allows patients to be immersed in a relaxing, peaceful environment. It represents a non-invasive way to reduce preoperative stress levels with no side effects and no need for additional medical or paramedical staff. Our results indicate that VR may provide an effective complementary technique to manage stress in surgery patients. Randomized trials are necessary to determine precise methods and benefits. Copyright © 2018 Elsevier Masson SAS. All rights reserved.

Montelukast for the high impact of asthma exacerbations in Venezuela: a practical and valid approach for Latin America?

PubMed

Capriles Hulett, Arnaldo; Yibirin, Maria Gonzalez; Garcia, Amaris; Hurtado, Dollys

2014-01-01

Asthma affects mainly Venezuela's urban and poor majority. Exacerbations bring about a high demand in health services, thus becoming a significant public health problem. In general, asthma control programs (GINA) with use of inhaled steroid medications have proven effective, although their implementation in real life remains cumbersome. Montelukast could be a useful and practical tool for these deprived socioeconomic sectors. This real-life pilot study was conducted in a prospective, double blinded, placebo-controlled manner with randomized and parallel groups. Asthmatics that had never used leukotriene modifiers were recruited and followed-up every three months. The main outcome was the number of exacerbations meriting use of nebulized bronchodilators administered by the health care system. Eighty-eight asthmatic patients were enrolled, between children and adults. Groups were comparable in: demographic data, previous use of other medications, ACT scores, pulmonary functions (Wright Peak Flow meter), allergy status (Skin Prick Test) as well as adherence to the prescribed Montelukast treatment. By an intention to treat (ITT), a total of 64 patients were included for analysis. For the three and six months time points the difference between placebo and Montelukast was found to be significant (p < 0.03 and p < 0.04, respectively). Such trends continued for the rest of the year, but without statistical significance, due to patient attrition. This real-life pilot study shows that a simplified strategy with oral Montelukast was practical and effective in controlling exacerbations in an asthmatic population of a vulnerable community from Caracas. Such an approach reinforces the role of primary care in asthma treatment.

Turbulence flight director analysis and preliminary simulation

NASA Technical Reports Server (NTRS)

Johnson, D. E.; Klein, R. E.

1974-01-01

A control column and trottle flight director display system is synthesized for use during flight through severe turbulence. The column system is designed to minimize airspeed excursions without overdriving attitude. The throttle system is designed to augment the airspeed regulation and provide an indication of the trim thrust required for any desired flight path angle. Together they form an energy management system to provide harmonious display indications of current aircraft motions and required corrective action, minimize gust upset tendencies, minimize unsafe aircraft excursions, and maintain satisfactory ride qualities. A preliminary fixed-base piloted simulation verified the analysis and provided a shakedown for a more sophisticated moving-base simulation to be accomplished next. This preliminary simulation utilized a flight scenario concept combining piloting tasks, random turbulence, and discrete gusts to create a high but realistic pilot workload conducive to pilot error and potential upset. The turbulence director (energy management) system significantly reduced pilot workload and minimized unsafe aircraft excursions.

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

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…

A Study on Chocolate Consumption in Prospective Teachers

ERIC Educational Resources Information Center

Ozgen, Leyla

2016-01-01

This study was planned and conducted to determine the chocolate consumption habits of prospective teachers. The study population was comprised of students attending the Faculty of Education at Gazi University in Ankara and the sample consisted of 251 prospective teachers selected with simple random sampling. 96.4% and 3.6% of the prospective…

The Relationship between Prospective Teachers' Critical Thinking Dispositions and Their Educational Philosophies

ERIC Educational Resources Information Center

Aybek, Birsel; Aslan, Serkan

2017-01-01

The aim of this research is to investigate the relationship between prospective teachers' critical thinking dispositions and their educational philosophies. The research used relational screening model. The study hosts a total of 429 prospective teachers selected by the simple random sampling method. Research data has been collected through…

Effect of Sirolimus on Native Total Kidney Volume After Transplantation in Patients with Autosomal Dominant Polycystic Kidney Disease: A Randomized Controlled Pilot Study.

PubMed

Davis, S; Gralla, J; Chan, L; Wiseman, A; Edelstein, C L

2018-06-01

The mammalian target of rapamycin (mTOR) pathway has been shown to be central to cyst formation and growth in patients with autosomal dominant polycystic kidney disease (ADPKD). Drugs that suppress mTOR signaling are frequently used as antiproliferative agents for maintenance immunosuppression in patients who have undergone kidney transplantation. The aim of this study was to determine the effect of sirolimus, an mTOR inhibitor, on cyst volume regression in patients with ADPKD who have undergone renal transplantation. In this single-center, prospective, open-label, parallel-group, randomized trial, 23 adult patients with ADPKD who successfully underwent renal transplantation from 2008 to 2012 were subsequently randomized (on a 1:1 basis) to a maintenance immunosuppression regimen with either sirolimus (sirolimus, tacrolimus, prednisone) or mycophenolate (mycophenolate, tacrolimus, prednisone). Total kidney volumes were measured by means of high-resolution magnetic resonance imaging within 2 weeks after transplantation and at 1 year. The primary end point was change in total kidney volume at 1 year. Sixteen patients completed the 1-year study (8 patients in each group). There was a decrease in kidney volume in both the sirolimus group (percentage change from baseline, 20.5%; P < .001) and mycophenolate group (percentage change from baseline, 17%; P = .048), but there was no significant difference in percentage change of total kidney volume between the groups (P = .665). In ADPKD patients at 1 year after kidney transplantation, there was a similar decrease in polycystic kidney volume in patients receiving an immunosuppression regimen containing sirolimus compared with patients receiving mycophenolate. Copyright © 2018 Elsevier Inc. All rights reserved.

Effect of Transcranial Direct Current Stimulation on Severely Affected Arm-Hand Motor Function in Patients After an Acute Ischemic Stroke: A Pilot Randomized Control Trial.

PubMed

Rabadi, Meheroz H; Aston, Christopher E

2017-10-01

The aim of this article was to determine whether cathodal transcranial direct current stimulation (c-tDCS) to unaffected primary motor cortex (PMC) plus conventional occupational therapy (OT) improves functional motor recovery of the affected arm hand in patients after an acute ischemic stroke compared with sham transcranial direct current stimulation plus conventional OT. In this prospective, randomized, double-blinded, sham-controlled trial of 16 severe, acute ischemic stroke patients with severe arm-hand weakness were randomly assigned to either experimental (c-tDCS plus OT; n = 8) or control (sham transcranial direct current stimulation plus OT; n = 8) groups. All patients received a standard 3-hr in-patient rehabilitation therapy, plus an additional ten 30-min sessions of tDCS. During each session, 1 mA of cathodal stimulation to the unaffected PMC is performed followed by the patient's scheduled OT. The primary outcome measure was change in Action Research Arm Test (ARAT) total and subscores on discharge. Application of c-tDCS to unaffected PMC resulted in a clinically relevant 10-point improvement in the affected arm-hand function based on ARAT total score compared with a 2-point improvement in the control group. Application of 30-min of c-tDCS to the unaffected PMC showed a 10-point improvement in the ARAT score. This corresponds to a large effect size in improvement of affected arm-hand function in patients with severe, acute ischemic stroke. Although not statistically significant, this suggests that larger studies, enrolling at least 25 patients in each group, and with a longer follow-up are warranted.

Acceptability of Family-Centered Advanced Care Planning for Adolescents With HIV

PubMed Central

Kimmel, Allison; Wilkins, Megan L.; Rana, Sohail; Garcia, Ana; Cheng, Yao I.; Wang, Jichuan; Lyon, Maureen E.

2016-01-01

BACKGROUND AND OBJECTIVE: Small pilot studies support the appropriateness of engaging adolescents with chronic or life-limiting illnesses in pediatric advance care planning (pACP). We do not yet know if pACP is acceptable, feasible, and worthwhile, even if emotionally intense, in a fully powered randomized controlled trial. METHODS: We conducted a prospective 2-arm randomized controlled trial at 6 US urban hospitals. Adolescent/family member dyads were randomized to receive the 1-session-a-week 3-session FAmily-CEntered Advance Care Planning (FACE) pACP intervention (1, ACP Survey; 2, Goals of Care Conversation/Treatment Preferences; 3, Completion of Advance Directive) or active comparator (1, Developmental History; 2, Safety Tips; 3, Nutrition/Exercise). The Satisfaction Questionnaire was administered to participants independently after each session by a blinded research assistant. RESULTS: We enrolled 53% of eligible participants and intervened with 97 adolescent/family dyads. Adolescents ranged in age from 14 to 21 years; 54% were male individuals; 93% African American; and 73% perinatally infected. Attendance was 99% for all 3 sessions in each arm. At session 3, FACE adolescents and family dyad members, respectively, found the session useful (98%, 98%) and helpful (98%, 100%), despite feelings of sadness (25%, 17%). FACE adolescents’ improvement in the total subscale A score (useful, helpful, like a load off my mind, satisfied, something I needed to do, courageous, worthwhile) was better than control adolescents at session 3 (β = 1.16, P = .02). There were no adverse events. CONCLUSIONS: FACE enabled worthwhile conversations, while simultaneously eliciting intense emotions. No participants withdrew, 99% of those enrolled completed each session, and there were no adverse events, evidence of pACP’s feasibility, acceptability, and safety. PMID:27940700

A pilot study of activity-based therapy in the arm motor recovery post stroke: a randomized controlled trial.

PubMed

Rabadi, Mh; Galgano, M; Lynch, D; Akerman, M; Lesser, M; Volpe, Bt

2008-12-01

To determine the efficacy of activity-based therapies using arm ergometer or robotic or group occupational therapy for motor recovery of the paretic arm in patients with an acute stroke (< or =4 weeks) admitted to an inpatient rehabilitation facility, and to obtain information to plan a large randomized controlled trial. Prospective, randomized controlled study. Stroke unit in a rehabilitation hospital. Thirty patients with an acute stroke (< or =4 weeks) who had arm weakness (Medical Research Council grade 2 or less at the shoulder joint). Occupational therapy (OT) group (control) (n = 10), arm ergometer (n = 10) or robotic (n = 10) therapy group. All patients received standard, inpatient, post-stroke rehabilitation training for 3 hours a day, plus 12 additional 40-minute sessions of the activity-based therapy. The primary outcome measures were discharge scores in the Fugl-Meyer Assessment Scale for upper limb impairment, Motor Status Scale, total Functional Independence Measure (FIM) and FIM-motor and FIM-cognition subscores. The three groups (OT group versus arm ergometer versus robotic) were comparable on clinical demographic measures except the robotic group was significantly older and there were more haemorrhagic stroke patients in the arm ergometer group. After adjusting for age, stroke type and outcome measures at baseline, a similar degree of improvement in the discharge scores was found in all of the primary outcome measures. This study suggests that activity-based therapies using an arm ergometer or robot when used over shortened training periods have the same effect as OT group therapy in decreasing impairment and improving disability in the paretic arm of severely affected stroke patients in the subacute phase.

Robotically assisted treadmill exercise training for improving peak fitness in chronic motor incomplete spinal cord injury: A randomized controlled trial

PubMed Central

Scott, William; York, Henry; Theyagaraj, Melita; Price-Miller, Naomi; McQuaid, Jean; Eyvazzadeh, Megan; Ivey, Frederick M.; Macko, Richard F.

2016-01-01

Objective To assess the effectiveness of robotically assisted body weight supported treadmill training (RABWSTT) for improving cardiovascular fitness in chronic motor incomplete spinal cord injury (CMISCI). Design Pilot prospective randomized, controlled clinical trial. Setting Outpatient rehabilitation specialty hospital. Participants Eighteen individuals with CMISCI with American Spinal Injury Association (ASIA) level between C4 and L2 and at least one-year post injury. Interventions CMISCI participants were randomized to RABWSTT or a home stretching program (HSP) three times per week for three months. Those in the home stretching group were crossed over to three months of RABWSTT following completion of the initial three month phase. Outcome measures Peak oxygen consumption (peak VO2) was measured during both robotic treadmill walking and arm cycle ergometry: twice at baseline, once at six weeks (mid-training) and twice at three months (post-training). Peak VO2 values were normalized for body mass. Results The RABWSTT group improved peak VO2 by 12.3% during robotic treadmill walking (20.2 ± 7.4 to 22.7 ± 7.5 ml/kg/min, P = 0.018), compared to a non-significant 3.9% within group change observed in HSP controls (P = 0.37). Neither group displayed a significant change in peak VO2 during arm cycle ergometry (RABWSTT, 8.5% (P = 0.25); HSP, 1.76% (P = 0.72)). A repeated measures analysis showed statistically significant differences between treatments for peak VO2 during both robotic treadmill walking (P = 0.002) and arm cycle ergometry (P = 0.001). Conclusion RABWSTT is an effective intervention model for improving peak fitness levels assessed during robotic treadmill walking in persons with CMISCI. PMID:25520035

A Cognitive Behavioral Smoking Abstinence Intervention for Adults with Chronic Pain: A Randomized Controlled Pilot Trial

PubMed Central

Hooten, W. Michael; Townsend, Cynthia O.; Hays, J. Taylor; Ebnet, Kaye L.; Gauvin, Thomas R.; Gehin, Jessica M.; Laures, Heidi J.; Patten, Christi A.; Warner, David O.

2015-01-01

Current evidence suggests it may be difficult for patients with chronic pain to quit smoking and, based on previous formative work, a 7-session individual and group-based cognitive behavioral (CB) intervention was developed. The primary aim of this randomized controlled pilot trial was to test the hypothesis that abstinence at month 6 would be greater among patients with chronic pain who received the CB intervention compared to a control condition. Upon admission to a 3-week interdisciplinary pain treatment (IPT) program, patients were randomized to receive the CB intervention (n = 30) or the control condition (n = 30). The 7-day point prevalence of self-reported smoking status was assessed at week 3 (upon completion of the 3-week IPT program) and at month 6 in an intent-to-treat analysis. At week 3, 30% (n=9) of patients in the CB condition were abstinent from smoking compared to 10% (n=3) in the control group (P=.104). At month 6, 20% (n=6) of patients who received the CB intervention were abstinent compared to none in the control group (P=.024). At week 3, a significant group by time interaction effect was found where the CB patients experienced greater improvements in self-efficacy from baseline compared to the control group (P=.002). A greater proportion of patients randomized to the CB group completed the IPT program (P=.052). The findings of this pilot trial suggest that integration of a CB-based smoking abstinence intervention into ongoing pain therapy may be an effective treatment for smokers with chronic pain. PMID:24333035

Pedometer Use in University Freshmen: A Randomized Controlled Pilot Study

ERIC Educational Resources Information Center

LeCheminant, James D.; Smith, John D.; Covington, N. Kay; Hardin-Renschen, Tracie; Heden, Tim

2011-01-01

Objectives: To describe activity patterns associated with a pedometer intervention in university freshmen and compare the intervention participants to controls for several health outcomes. Methods: Forty-six university freshmen were randomized to a group that wore a pedometer across the academic year with a goal of 10,000 steps/day or to a control…

Social Skills Training for Young Adults with High-Functioning Autism Spectrum Disorders: A Randomized Controlled Pilot Study

ERIC Educational Resources Information Center

Gantman, Alexander; Kapp, Steven K.; Orenski, Kaely; Laugeson, Elizabeth A.

2012-01-01

Despite the psychosocial difficulties common among young adults with autism spectrum disorders (ASD), little to no evidence-based social skills interventions exist for this population. Using a randomized controlled trial (RCT) design, the current study tested the effectiveness of an evidence-based, caregiver-assisted social skills intervention…

Cognitive-Behavioral Therapy for Intermittent Explosive Disorder: A Pilot Randomized Clinical Trial

ERIC Educational Resources Information Center

McCloskey, Michael S.; Noblett, Kurtis L.; Deffenbacher, Jerry L.; Gollan, Jackie K.; Coccaro, Emil F.

2008-01-01

No randomized clinical trials have evaluated the efficacy of psychotherapy for intermittent explosive disorder (IED). In the present study, the authors tested the efficacy of 12-week group and individual cognitive-behavioral therapies (adapted from J. L. Deffenbacher & M. McKay, 2000) by comparing them with a wait-list control in a randomized…

Reducing Sexual Risk Behaviors for HIV/STDs in Women with Alcohol Use Disorders

ERIC Educational Resources Information Center

Langhorst, Diane M.; Choi, Y. Joon; Keyser-Marcus, Lori; Svikis, Dace S.

2012-01-01

Objective: A pilot randomized clinical trial (RCT) examined effectiveness of HIV/STD Safer Sex Skills Building + Alcohol (SSB+A) intervention for women with Alcohol Use Disorders (AUDs) in a residential treatment setting. Method: After randomizing thirty-six women with AUDs and reporting having intercourse with a male partner in the past 180 days…

A Pilot Randomized Controlled Trial of a Guided Self-Help Intervention to Manage Chronic Orofacial Pain.

PubMed

Goldthorpe, Joanna; Lovell, Karina; Peters, Sarah; McGowan, Linda; Nemeth, Imola; Roberts, Christopher; Aggarwal, Vishal R

2017-01-01

To conduct a pilot trial to test the feasibility of a guided self-help intervention for chronic orofacial pain. A pilot randomized controlled trial was conducted to compare the intervention with usual treatment. A total of 37 patients with chronic orofacial pain were randomized into either the intervention group (n = 19) or the usual treatment (control) group (n = 18). Validated outcome measures were used to measure the potential effectiveness of the intervention over a number of domains: physical and mental functioning (Short Form 36 [SF-36]); anxiety and depression (Hospital Anxiety and Depression Scale [HADS]); pain intensity and interference with life (Brief Pain Inventory [BPI]); disability (Manchester Orofacial Pain Disability Scale [MOPDS]); and illness behavior (Revised Illness Perceptions Questionnaire [IPQr]). Bootstrap confidence intervals were computed for the treatment effect (ES) posttreatment and at 3 months follow-up and adjusted for baseline values of the outcome measure by using analysis of covariance. At posttreatment and the 3-month follow-up, 11 participants in the intervention group and 7 in the control group failed to complete outcome measures. The intervention was acceptable and could be feasibly delivered face to face or over the telephone. Although the pilot trial was not powered to draw conclusions about the effectiveness, it showed significant (P < .05) effects of the intervention on physical and mental functioning and treatment control. The self-help intervention was acceptable to patients and allowed them to better understand and self-manage chronic orofacial pain. It showed potential effectiveness on outcome domains related to functioning and illness perception. Further research is needed to understand the cost effectiveness of the intervention for chronic orofacial pain.

Motor/Prefrontal Transcranial Direct Current Stimulation (tDCS) Following Lumbar Surgery Reduces Postoperative Analgesia Use.

PubMed

Glaser, John; Reeves, Scott T; Stoll, William David; Epperson, Thomas I; Hilbert, Megan; Madan, Alok; George, Mark S; Borckardt, Jeffrey J

2016-05-01

Randomized, controlled pilot trial. The present study is the first randomized, double-blind, sham-controlled pilot clinical trial of transcranial direct current stimulation (tDCS) for pain and patient-controlled analgesia (PCA) opioid usage among patients receiving spine surgery. Lumbar spinal surgeries are common, and while pain is often a complaint that precedes surgical intervention, the procedures themselves are associated with considerable postoperative pain lasting days to weeks. Adequate postoperative pain control is an important factor in determining recovery and new analgesic strategies are needed that can be used adjunctively to existing strategies potentially to reduce reliance on opioid analgesia. Several novel brain stimulation technologies including tDCS are beginning to demonstrate promise as treatments for a variety of pain conditions. Twenty-seven patients undergoing lumbar spine procedures at Medical University of South Carolina were randomly assigned to receive four 20-minute sessions of real or sham tDCS during their postsurgical hospital stay. Patient-administered hydromorphone usage was tracked along with numeric rating scale pain ratings. The effect of tDCS on the slope of the cumulative PCA curve was significant (P < 0.001) and tDCS was associated with a 23% reduction in PCA usage. In the real tDCS group a 31% reduction was observed in pain-at-its-least ratings from admission to discharge (P = 0.027), but no other changes in numeric rating scale pain ratings were significant in either group. The present pilot trial is the first study to demonstrate an opioid sparing effect of tDCS after spine surgical procedures. Although this was a small pilot trial in a heterogeneous sample of spinal surgery patients, a moderate effect-size was observed for tDCS, suggesting that future work in this area is warranted. 2.

Being “SMART” about Adolescent Conduct Problems Prevention: Executing a SMART Pilot Study in a Juvenile Diversion Agency

PubMed Central

August, Gerald J.; Piehler, Timothy F.; Bloomquist, Michael L.

2014-01-01

OBJECTIVE The development of adaptive treatment strategies (ATS) represents the next step in innovating conduct problems prevention programs within a juvenile diversion context. Towards this goal, we present the theoretical rationale, associated methods, and anticipated challenges for a feasibility pilot study in preparation for implementing a full-scale SMART (i.e., sequential, multiple assignment, randomized trial) for conduct problems prevention. The role of a SMART design in constructing ATS is presented. METHOD The SMART feasibility pilot study includes a sample of 100 youth (13–17 years of age) identified by law enforcement as early stage offenders and referred for pre-court juvenile diversion programming. Prior data on the sample population detail a high level of ethnic diversity and approximately equal representations of both genders. Within the SMART, youth and their families are first randomly assigned to one of two different brief-type evidence-based prevention programs, featuring parent-focused behavioral management or youth-focused strengths-building components. Youth who do not respond sufficiently to brief first-stage programming will be randomly assigned a second time to either an extended parent- or youth-focused second-stage programming. Measures of proximal intervention response and measures of potential candidate tailoring variables for developing ATS within this sample are detailed. RESULTS Results of the described pilot study will include information regarding feasibility and acceptability of the SMART design. This information will be used to refine a subsequent full-scale SMART. CONCLUSIONS The use of a SMART to develop ATS for prevention will increase the efficiency and effectiveness of prevention programing for youth with developing conduct problems. PMID:25256135

Using music to reduce anxiety among older adults in the emergency department: a randomized pilot study.

PubMed

Belland, Laura; Rivera-Reyes, Laura; Hwang, Ula

2017-11-01

An emergency department (ED) visit may be distressing and anxiety-provoking for older adults (age > 65 years). No studies have specifically evaluated the effect of music listening on anxiety in older adults in the ED. The objective of this pilot study was to evaluate the effect of music listening on anxiety levels in older ED patients. This was a randomized pilot study in the geriatric ED of an urban academic tertiary medical center. This was a sample of English-speaking adults (age > 65 years) who were not deaf (n = 35). Subjects consented to participate and were randomized to receive up to 60 min of music listening with routine care, while the control group received routine care with no music. Subjects in the music treatment group received headphones and an electronic tablet with pre-downloaded music, and were allowed to choose from 5 selections. The primary outcome was change in anxiety levels, measured by the state-trait anxiety inventory (STAI), at enrollment and 1 h later. A total of 35 participants were enrolled: 74% were female, 40% were white, and 40% were black; of these, 32 subjects completed the study protocol. When comparing control (n = 18) against intervention subjects (n = 17), there were no significant differences in enrollment STAI scores (43.00 ± 15.00 vs. 40.30 ± 12.80, P = 0.57). STAI scores 1 hour after enrollment (after the music intervention) were significantly reduced in the intervention subjects compared to the control subjects (with reduction of 10.00 ± 12.29 vs. 1.88 ± 7.97, P = 0.03). These pilot results suggest that music listening may be an effective tool for reducing anxiety among older adults in the ED.

Running injuries in novice runners enrolled in different training interventions: a pilot randomized controlled trial.

PubMed

Baltich, J; Emery, C A; Whittaker, J L; Nigg, B M

2017-11-01

The purpose of this trial was to evaluate injury risk in novice runners participating in different strength training interventions. This was a pilot randomized controlled trial. Novice runners (n = 129, 18-60 years old, <2 years recent running experience) were block randomized to one of three groups: a "resistance" strength training group, a "functional" strength training group, or a stretching "control" group. The primary outcome was running related injury. The number of participants with complaints and the injury rate (IR = no. injuries/1000 running hours) were quantified for each intervention group. For the first 8 weeks, participants were instructed to complete their training intervention three to five times a week. The remaining 4 months was a maintenance period. NCT01900262. A total of 52 of the 129 (40%) novice runners experienced at least one running related injury: 21 in the functional strength training program, 16 in the resistance strength training program and 15 in the control stretching program. Injury rates did not differ between study groups [IR = 32.9 (95% CI 20.8, 49.3) in the functional group, IR = 31.6 (95% CI 18.4, 50.5) in the resistance group, and IR = 26.7 (95% CI 15.2, 43.2)] in the control group. Although this was a pilot assessment, home-based strength training did not appear to alter injury rates compared to stretching. Future studies should consider methods to minimize participant drop out to allow for the assessment of injury risk. Injury risk in novice runners based on this pilot study will inform the development of future larger studies investigating the impact of injury prevention interventions. © 2016 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

Effects of a tele-prehabilitation program or an in-person prehabilitation program in surgical candidates awaiting total hip or knee arthroplasty: Protocol of a pilot single blind randomized controlled trial.

PubMed

Doiron-Cadrin, Patrick; Kairy, Dahlia; Vendittoli, Pascal-André; Lowry, Véronique; Poitras, Stéphane; Desmeules, François

2016-12-15

The accessibility for total joint arthroplasty often comes up against long wait lists, and may lead to deleterious effects for the awaiting patients. This pilot single blind randomized controlled trial aims to evaluate the impact of a telerehabilitation prehabilitation program before a hip or knee arthroplasty compared to in-person prehabilitation or to usual wait for surgery. Thirty-six patients on a wait list for a total hip or knee arthroplasty will be recruited and randomly assigned to one of three groups. The in-person prehabilitation group (n = 12) will receive a 12-week rehabilitation program (2 sessions/week) including education, exercises of the lower limb and cardiovascular training. Patients in the tele-prehabilitation group (n = 12) will receive the same intervention using a telecommunication software. The control group (n = 12) will be provided with the hospital's usual documentation before surgery. The Lower Extremity Functional Scale (LEFS) will be the primary outcome measure taken at baseline and at 12 weeks. Secondary measures will include self-reported function and quality of life as well as performance tests. A mixed-model, 2-way repeated-measure ANOVA will be used to analyse the effects of the rehabilitation programs. This pilot study is the first to evaluate the feasibility and the impact of a telerehabilitation prehabilitation program for patients awaiting a total joint arthroplasty. The results of this pilot-RCT will set the foundations for further research in the fields of rehabilitation and tele-medicine for patients suffering from lower limb osteoarthritis. ClinicalTrials.gov: NCT02636751.

A prospective, randomized pilot study on the safety and efficacy of recombinant human growth and differentiation factor-5 coated onto β-tricalcium phosphate for sinus lift augmentation.

PubMed

Koch, Felix P; Becker, Jürgen; Terheyden, Hendrik; Capsius, Björn; Wagner, Wilfried

2010-11-01

The aim of this prospective, randomized clinical trial was to investigate the potential of recombinant human growth and differentiation factor-5 (rhGDF-5) coated onto β-tricalcium phosphate (β-TCP) (rhGDF-5/β-TCP) to support bone formation after sinus lift augmentation. In total, 31 patients participated in this multicenter clinical trial. They required a two-stage unilateral maxillary sinus floor augmentation (residual bone height <5 mm). According to a parallel-group design, the patients were randomized to three treatment groups: (a) augmentation with rhGDF-5/β-TCP and a 3-month healing period, (b) augmentation with rhGDF-5/β-TCP and a 4-month healing period and (c) medical device β-TCP mixed with autologous bone and a 4-month healing period. The primary study objective was the area of newly formed bone within the augmented area as assessed by histomorphometric evaluation of trephine bur biopsies. The osseous regeneration was similar in each treatment group; the amount of newly formed bone ranged between 28% (± 15.5%) and 31.8% (± 17.9%). Detailed analysis of histological data will be published elsewhere. As secondary efficacy variables, the augmentation height at the surgery site was measured by radiography. The largest augmentation was radiologically achieved in the rhGDF-5/β-TCP - 3-month and the rhGDF-5/β-TCP - 4-month treatment groups. As safety parameters, adverse events were recorded and anti-drug antibody levels were evaluated. Most of the adverse events were judged as unrelated to the study medication. Four out of 47 (8.5%) implants failed in patients treated with rhGDF-5/β-TCP, a result that is in agreement with the general implant failure rate of 5-15%. Transiently very low amounts of anti-rhGDF-5 antibodies were detected in some patients who received rhGDF-5, which was not related to the bone formation outcome. rhGDF-5/β-TCP was found to be effective and safe as the control treatment with autologous bone mixed β-TCP in sinus floor augmentation. Thus, further investigation regarding efficacy and safety will be carried out in larger patient populations. © 2010 John Wiley & Sons A/S.

A pilot randomized controlled trial of the Yoga of Awareness program in the management of fibromyalgia

PubMed Central

Carson, James W.; Carson, Kimberly M.; Jones, Kim D.; Bennett, Robert M.; Wright, Cheryl L.; Mist, Scott D.

2017-01-01

A mounting body of literature recommends that treatment for fibromyalgia (FM) encompass medications, exercise and improvement of coping skills. However, there is a significant gap in determining an effective counterpart to pharmacotherapy that incorporates both exercise and coping. The aim of this randomized controlled trial was to evaluate the effects of a comprehensive yoga intervention on FM symptoms and coping. A sample of 53 female FM patients were randomized to the 8-week Yoga of Awareness program (gentle poses, meditation, breathing exercises, yoga-based coping instructions, group discussions) or to wait-listed standard care. Data were analyzed by intention to treat. At post-treatment, women assigned to the yoga program showed significantly greater improvements on standardized measures of FM symptoms and functioning, including pain, fatigue, and mood, and in pain catastrophizing, acceptance, and other coping strategies. This pilot study provides promising support for the potential benefits of a yoga program for women with FM. PMID:20946990

A randomized controlled pilot study of the effectiveness of occupational therapy for children with sensory modulation disorder.

PubMed

Miller, Lucy Jane; Coll, Joseph R; Schoen, Sarah A

2007-01-01

A pilot randomized controlled trial (RCT) of the effectiveness of occupational therapy using a sensory integration approach (OT-SI) was conducted with children who had sensory modulation disorders (SMDs). This study evaluated the effectiveness of three treatment groups. In addition, sample size estimates for a large scale, multisite RCT were calculated. Twenty-four children with SMD were randomly assigned to one of three treatment conditions; OT-SI, Activity Protocol, and No Treatment. Pretest and posttest measures of behavior, sensory and adaptive functioning, and physiology were administered. The OT-SI group, compared to the other two groups, made significant gains on goal attainment scaling and on the Attention subtest and the Cognitive/Social composite of the Leiter International Performance Scale-Revised. Compared to the control groups, OT-SI improvement trends on the Short Sensory Profile, Child Behavior Checklist, and electrodermal reactivity were in the hypothesized direction. Findings suggest that OT-SI may be effective in ameliorating difficulties of children with SMD.

A Randomized, Controlled Pilot Study of a Single-Session Psychoeducation Treatment for Urban, Culturally Diverse, Trauma-Exposed Adults.

PubMed

Ghafoori, Bita; Fisher, Dennis; Korosteleva, Olga; Hong, Madelyn

2016-06-01

This randomized pilot study aimed to determine whether a single session of psychoeducation improved mental health outcomes, attitudes toward treatment, and service engagement among urban, impoverished, culturally diverse, trauma-exposed adults. Sixty-seven individuals were randomly assigned to a single-session psychoeducation treatment or a delayed treatment comparison control group. The control group was found to be superior to the treatment group at posttest with respect to symptoms of posttraumatic stress disorder, anxiety, and occupational and family disability. At follow-up, all participants had completed the psychoeducation treatment, and a mixed-effects model indicated significant improvements over time in symptoms of posttraumatic stress disorder, anxiety, depression, somatization, and attitudes toward treatment. Ninety-eight percent of the participants reported the psychoeducation was helpful at follow-up. Participants also reported a 19.1% increase in mental health service utilization at follow-up compared with baseline. Implications for treatment and future research are discussed.

Pressing the Approach: A NASA Study of 19 Recent Accidents Yields a New Perspective on Pilot Error

NASA Technical Reports Server (NTRS)

Berman, Benjamin A.; Dismukes, R. Key

2007-01-01

This article begins with a review of two sample airplane accidents that were caused by pilot error. The analysis of these and 17 other accidents suggested that almost all experienced pilot operating in the same environment in which the accident crews were operating and knowing only what the accident crews knew at each moment of the flight, would be vulnerable to making a similar decision and similar errors. Whether a particular crew in a given situation makes errors depends on somewhat random interaction of factors. Two themes that seem to be prevalent in these cases are: Plan Continuation Bias, and Snowballing Workload.

Conducting pilot and feasibility studies.

PubMed

Cope, Diane G

2015-03-01

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

Hypothermia for Traumatic Brain Injury in Children-A Phase II Randomized Controlled Trial.

PubMed

Beca, John; McSharry, Brent; Erickson, Simon; Yung, Michael; Schibler, Andreas; Slater, Anthony; Wilkins, Barry; Singhal, Ash; Williams, Gary; Sherring, Claire; Butt, Warwick

2015-07-01

To perform a pilot study to assess the feasibility of performing a phase III trial of therapeutic hypothermia started early and continued for at least 72 hours in children with severe traumatic brain injury. Multicenter prospective randomized controlled phase II trial. All eight of the PICUs in Australia and New Zealand and one in Canada. Children 1-15 years old with severe traumatic brain injury and who could be randomized within 6 hours of injury. The control group had strict normothermia to a temperature of 36-37°C for 72 hours. The intervention group had therapeutic hypothermia to a temperature of 32-33°C for 72 hours followed by slow rewarming at a rate compatible with maintaining intracranial pressure and cerebral perfusion pressure. Of 764 children admitted to PICU with traumatic brain injury, 92 (12%) were eligible and 55 (7.2%) were recruited. There were five major protocol violations (9%): three related to recruitment and consent processes and two to incorrect temperature management. Rewarming took a median of 21.5 hours (16-35 hr) and was performed without compromise in the cerebral perfusion pressure. There was no increase in any complications, including infections, bleeding, and arrhythmias. There was no difference in outcomes 12 months after injury; in the therapeutic hypothermia group, four (17%) had a bad outcome (pediatric cerebral performance category, 4-6) and three (13%) died, whereas in the normothermia group, three (12%) had a bad outcome and one (4%) died. Early therapeutic hypothermia in children with severe traumatic brain injury does not improve outcome and should not be used outside a clinical trial. Recruitment rates were lower and outcomes were better than expected. Conventional randomized controlled trials in children with severe traumatic brain injury are unlikely to be feasible. A large international trials group and alternative approaches to trial design will be required to further inform practice.

Renal function following xenon anesthesia for partial nephrectomy-An explorative analysis of a randomized controlled study.

PubMed

Stevanovic, Ana; Schaefer, Patrick; Coburn, Mark; Rossaint, Rolf; Stoppe, Christian; Boor, Peter; Pfister, David; Heidenreich, Axel; Christ, Hildegard; Hellmich, Martin; Fahlenkamp, Astrid V

2017-01-01

Perioperative preservation of renal function has a significant impact on morbidity and mortality in kidney surgery. Nephroprotective effects of the anesthetic xenon on ischemia-reperfusion injury were found in several experimental studies. We aimed to explore whether xenon anesthesia can reduce renal damage in humans undergoing partial nephrectomy and to gather pilot data of possible nephroprotection in these patients. A prospective randomized, single-blinded, controlled study. Single-center, University Hospital of Aachen, Germany between July 2013-October 2015. Forty-six patients with regular renal function undergoing partial nephrectomy. Patients were randomly assigned to receive xenon- (n = 23) or isoflurane (n = 23) anesthesia. Primary outcome was the maximum postoperative glomerular filtration rate (GFR) decline within seven days after surgery. Secondary outcomes included intraoperative and tumor-related data, assessment of further kidney injury markers, adverse events and optional determination of renal function after 3-6 months. Unexpected radical nephrectomy was performed in 5 patients, thus they were excluded from the per-protocol analysis, but included in the intention-to-treat analysis. The maximum postoperative GFR decline was attenuated by 45% in the xenon-group (10.9 ml min-1 1.73 cm-2 versus 19.7 ml min-1 1.73 cm-2 in the isoflurane group), but without significance (P = 0.084). Occurrence of adverse events was reduced (P = 0.003) in the xenon group. Renal function was similar among the groups after 3-6 months. Xenon anesthesia was feasible and safe in patients undergoing partial nephrectomy with regard to postoperative renal function. We found no significant effect on early renal function but less adverse events in the xenon group. Larger randomized controlled studies in more heterogeneous collectives are required, to confirm or refute the possible clinical benefit on renal function by xenon. ClinicalTrials.gov NCT01839084 and EudraCT 2012-005698-30.

Protocol of a randomized controlled trial of the fear of recurrence therapy (FORT) intervention for women with breast or gynecological cancer.

PubMed

Maheu, Christine; Lebel, Sophie; Courbasson, Christine; Lefebvre, Monique; Singh, Mina; Bernstein, Lori J; Muraca, Linda; Benea, Aronela; Jolicoeur, Lynne; Harris, Cheryl; Ramanakumar, Agnihotram V; Ferguson, Sarah; Sidani, Souraya

2016-04-25

Clinically significant levels of fear of cancer recurrence (FCR) affect up to 49% of cancer survivors and are more prevalent among women. FCR is associated with psychological distress, lower quality of life, and increased use of medical resources. Despite its prevalence, FCR is poorly addressed in clinical care. To address this problem, we first developed, and pilot tested a 6-week, 2 h, Cognitive-existential group intervention therapy that targeted FCR in survivors of breast or gynecological cancer. Following the positive outcome of the pilot, we are now testing this approach in a randomized clinical trial (RCT). Goal and hypotheses: This multicenter, prospective RCT aims to test the efficacy of the intervention. The study hypotheses are that, compared to a control group, cancer survivors participating in the intervention (1) will have less FCR, (2) will show more favorable outcomes on the following measures: cancer-specific distress, quality of life, illness uncertainty, intolerance of uncertainty, perceived risk of cancer recurrence, and coping skills. We further postulate that the between-group differences will persist three and 6 months post-intervention. Sixteen groups of seven to nine women are being allocated to the intervention or the control group. The control group receives a 6-week, 2 h, structurally equivalent support group. We are recruiting 144 cancer survivors from four hospital sites in three Canadian cities. The sample size was based on the moderate pre/post-test changes found in our pilot study and adjusted to the drop-out rates. The primary outcome, FCR, is measured by the Fear of Cancer Recurrence Inventory. Secondary outcomes measured include cancer-specific distress, perceived risk of cancer recurrence, illness uncertainty, intolerance of uncertainty, coping, and quality of life. We use reliable and recognized valid scales. Participants are to complete the questionnaire package at four times: before the first group session (baseline), immediately after the sixth session, and 3 and 6 months post-intervention. In the descriptive analysis, comparison of group equivalent baseline variables, identification of confounding/intermediate variables and univariate analysis are planned. Each participant's trajectory is calculated using Generalized Estimating Equation models to determine the time and group effects, after considering the correlation structures of the groups. An intent-to-treat analysis approach may be adopted. Our Fear of Recurrence Therapy (FORT) intervention has direct implications for clinical service development to improve the quality of life for patients with breast (BC) and gynecological cancer (GC). Based on our pilot data, we are confident that the FORT intervention can guide the development of effective psychosocial cancer survivorship interventions to reduce FCR and improve psychological functioning among women with BC or GC. Dr. Christine Maheu registered the trial with ISRCTN registry (Registration number: ISRCTN83539618, date assigned 03/09/2014).

Effects of periodontal treatment on lung function and exacerbation frequency in patients with chronic obstructive pulmonary disease and chronic periodontitis: a 2-year pilot randomized controlled trial.

PubMed

Zhou, Xuan; Han, Jing; Liu, Zhiqiang; Song, Yiqing; Wang, Zuomin; Sun, Zheng

2014-06-01

To evaluate the direct effects of periodontal therapy in Chronic Obstructive Pulmonary Disease (COPD) patients with chronic periodontitis (CP). In a pilot randomized controlled trial, 60 COPD patients with CP were randomly assigned to receive scaling and root planing (SRP) treatment, supragingival scaling treatment, or oral hygiene instructions only with no periodontal treatment. We evaluated their periodontal indexes, respiratory function, and COPD exacerbations at baseline, 6 months, 1, and 2 years. Compared with the control group, measurements of periodontal indexes were significantly improved in patients in two treatment groups at 6-month, 1-year, and 2-year follow-up (all p < 0.05). Overall, the means of forced expiratory volume in the first second/forced vital capacity (FEV1/FVC) and FEV1 were significantly higher in the two therapy groups compared with the control group during the follow-up (p < 0.05). In addition, the frequencies of COPD exacerbation were significantly lower in the two therapy groups than in the control group at 2-year follow-up (p < 0.05). Our preliminary results from this pilot trial suggest that periodontal therapy in COPD patients with CP may improve lung function and decrease the frequency of COPD exacerbation. © 2014 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

Reach Out Churches: A Community-Based Participatory Research Pilot Trial to Assess the Feasibility of a Mobile Health Technology Intervention to Reduce Blood Pressure Among African Americans.

PubMed

Skolarus, Lesli E; Cowdery, Joan; Dome, Mackenzie; Bailey, Sarah; Baek, Jonggyu; Byrd, James Brian; Hartley, Sarah E; Valley, Staci C; Saberi, Sima; Wheeler, Natalie C; McDermott, Mollie; Hughes, Rebecca; Shanmugasundaram, Krithika; Morgenstern, Lewis B; Brown, Devin L

2017-06-01

Innovative strategies are needed to reduce the hypertension epidemic among African Americans. Reach Out was a faith-collaborative, mobile health, randomized, pilot intervention trial of four mobile health components to reduce high blood pressure (BP) compared to usual care. It was designed and tested within a community-based participatory research framework among African Americans recruited and randomized from churches in Flint, Michigan. The purpose of this pilot study was to assess the feasibility of the Reach Out processes. Feasibility was assessed by willingness to consent (acceptance of randomization), proportion of weeks participants texted their BP readings (intervention use), number lost to follow-up (retention), and responses to postintervention surveys and focus groups (acceptance of intervention). Of the 425 church members who underwent BP screening, 94 enrolled in the study and 73 (78%) completed the 6-month outcome assessment. Median age was 58 years, and 79% were women. Participants responded with their BPs on an average of 13.7 (SD = 10.7) weeks out of 26 weeks that the BP prompts were sent. All participants reported satisfaction with the intervention. Reach Out, a faith-collaborative, mobile health intervention was feasible. Further study of the efficacy of the intervention and additional mobile health strategies should be considered.

CoDuSe group exercise programme improves balance and reduces falls in people with multiple sclerosis: A multi-centre, randomized, controlled pilot study.

PubMed

Carling, Anna; Forsberg, Anette; Gunnarsson, Martin; Nilsagård, Ylva

2017-09-01

Imbalance leading to falls is common in people with multiple sclerosis (PwMS). To evaluate the effects of a balance group exercise programme (CoDuSe) on balance and walking in PwMS (Expanded Disability Status Scale, 4.0-7.5). A multi-centre, randomized, controlled single-blinded pilot study with random allocation to early or late start of exercise, with the latter group serving as control group for the physical function measures. In total, 14 supervised 60-minute exercise sessions were delivered over 7 weeks. Pretest-posttest analyses were conducted for self-reported near falls and falls in the group starting late. Primary outcome was Berg Balance Scale (BBS). A total of 51 participants were initially enrolled; three were lost to follow-up. Post-intervention, the exercise group showed statistically significant improvement ( p = 0.015) in BBS and borderline significant improvement in MS Walking Scale ( p = 0.051), both with large effect sizes (3.66; -2.89). No other significant differences were found between groups. In the group starting late, numbers of falls and near falls were statistically significantly reduced after exercise compared to before ( p < 0.001; p < 0.004). This pilot study suggests that the CoDuSe exercise improved balance and reduced perceived walking limitations, compared to no exercise. The intervention reduced falls and near falls frequency.

Child Directed Interaction Training for young children in kinship care: A pilot study.

PubMed

N'zi, Amanda M; Stevens, Monica L; Eyberg, Sheila M

2016-05-01

This pilot study used a randomized controlled trial design to examine the feasibility and explore initial outcomes of a twice weekly, 8-session Child Directed Interaction Training (CDIT) program for children living in kinship care. Participants included 14 grandmothers and great-grandmothers with their 2- to 7-year-old children randomized either to CDIT or a waitlist control condition. Training was delivered at a local, community library with high fidelity to the training protocol. There was no attrition in either condition. After training, kinship caregivers in the CDIT condition demonstrated more positive relationships with their children during behavioral observation. The caregivers in the CDIT condition also reported clinically and statistically significant decreases in parenting stress and caregiver depression, as well as fewer externalizing child behavior problems than waitlist controls. Parent daily report measures indicated significant changes in disciplining that included greater use of limit-setting and less use of critical verbal force. Results appeared stable at 3-month follow-up. Changes in child internalizing behaviors and caregiver use of non-critical verbal force were not seen until 3-month follow-up. Results of this pilot study suggest both the feasibility of conducting full scale randomized clinical trials of CDIT in the community and the promise of this approach for providing effective parent training for kinship caregivers. Copyright © 2016 Elsevier Ltd. All rights reserved.

Neuromuscular electrical stimulation in mechanically ventilated patients: a randomized, sham-controlled pilot trial with blinded outcome assessment.

PubMed

Kho, Michelle E; Truong, Alexander D; Zanni, Jennifer M; Ciesla, Nancy D; Brower, Roy G; Palmer, Jeffrey B; Needham, Dale M

2015-02-01

The purpose of the study is to compare neuromuscular electrical stimulation (NMES) vs sham on leg strength at hospital discharge in mechanically ventilated patients. We conducted a randomized pilot study of NMES vs sham applied to 3 bilateral lower extremity muscle groups for 60 minutes daily in the intensive care unit (ICU). Between June 2008 and March 2013, we enrolled adults who were receiving mechanical ventilation within the first week of ICU stay and who could transfer independently from bed to chair before hospital admission. The primary outcome was lower extremity muscle strength at hospital discharge using Medical Research Council score (maximum, 30). Secondary outcomes at hospital discharge included walking distance and change in lower extremity strength from ICU awakening. Clinicaltrials.gov: NCT00709124. We stopped enrollment early after 36 patients due to slow patient accrual and the end of research funding. For NMES vs sham, mean (SD) lower extremity strength was 28 (2) vs 27 (3), P = .072. Among secondary outcomes, NMES vs sham patients had a greater mean (SD) walking distance (514 [389] vs 251 [210] ft, P = .050) and increase in muscle strength (5.7 [5.1] vs 1.8 [2.7], P = .019). In this pilot randomized trial, NMES did not significantly improve leg strength at hospital discharge. Significant improvements in secondary outcomes require investigation in future research. Copyright © 2014 Elsevier Inc. All rights reserved.

Multicenter Randomized Controlled Trial on Duration of Therapy for Thrombosis in Children and Young Adults (Kids-DOTT): Pilot/Feasibility Phase Findings

PubMed Central

Goldenberg, N.A.; Abshire, T.; Blatchford, P.J.; Fenton, L.Z.; Halperin, J.L.; Hiatt, W.R.; Kessler, C.M.; Kittelson, J.M.; Manco-Johnson, M.J.; Spyropoulos, A.C.; Steg, P.G.; Stence, N.V.; Turpie, A.G.G.; Schulman, S.

2015-01-01

BACKGROUND Randomized controlled trials (RCTs) in pediatric venous thromboembolism (VTE) treatment have been challenged by unsubstantiated design assumptions and/or poor accrual. Pilot/feasibility (P/F) studies are critical to future RCT success. METHODS Kids-DOTT is a multicenter RCT investigating non-inferiority of a 6-week (shortened) vs. 3-month (conventional) duration of anticoagulation in patients <21 years old with provoked venous thrombosis. Primary efficacy and safety endpoints are symptomatic recurrent VTE at 1 year and anticoagulant-related, clinically-relevant bleeding. In the P/F phase, 100 participants were enrolled in an open, blinded endpoint, parallel-cohort RCT design. RESULTS No eligibility violations or randomization errors occurred. Of enrolled patients, 69% were randomized, 3% missed the randomization window, and 28% were followed in pre-specified observational cohorts for completely occlusive thrombosis or persistent antiphospholipid antibodies. Retention at 1 year was 82%. Inter-observer agreement between local vs. blinded central determination of venous occlusion by imaging at 6 weeks post-diagnosis was strong (κ-statistic=0.75; 95% confidence interval [CI] 0.48–1.0). Primary efficacy and safety event rates were 3.3% (95% CI 0.3–11.5%) and 1.4% (0.03–7.4%). CONCLUSIONS The P/F phase of Kids-DOTT has demonstrated validity of vascular imaging findings of occlusion as a randomization criterion, and defined randomization, retention, and endpoint rates to inform the fully-powered RCT. PMID:26118944

Effect of Nd:YAG laser-assisted non-surgical periodontal therapy on clinical periodontal and serum biomarkers in patients with and without coronary artery disease: A short-term pilot study.

PubMed

Javed, Fawad; Kellesarian, Sergio V; Al-Kheraif, Abdulaziz A; Ranna, Vinisha; Qadri, Talat; Yunker, Michael; Malmstrom, Hans; Romanos, Georgios E

2016-12-01

We hypothesized that nonsurgical-periodontal-therapy (NSPT) with adjunct Nd:YAG laser therapy is more effective in reducing periodontal inflammatory parameters (plaque index [PI], bleeding-on-probing [BOP], and probing-pocket-depth [PPD]) and serum interleukin-1beta (IL-1β) and matrix metalloproteinase-9 (MMP-9) levels in patients with and without coronary artery disease (CAD) than NSPT alone. The aim of this short-term pilot study was to assess the effect of NSPT + Nd:YAG laser therapy on periodontal parameters and serum IL-1β and MMP-9 levels in patients with and without CAD. A prospective randomized clinical study was conducted on 87 patients who were divided into two groups: Group-1: 44 patients with CAD and periodontal disease (PD) and Group-2: 43 patients with PD alone. Treatment-wise, these individuals were randomly divided into two subgroups: (i) NSPT alone and (ii) NSPT + Nd:YAG laser therapy. Demographic information was collected using a self-completed questionnaire. Periodontal parameters (PI, BOP, and PPD) and serum IL-1β and MMP-9 levels were measured at baseline and after 3 months of treatment. P-values <0.05 were considered statistically significant. At 3 months follow-up, PI (P < 0.01), BOP (P < 0.01), PPD ≥ 4 mm (P < 0.01), and serum IL-1β (P < 0.01) and MMP-9 (P < 0.01) levels were significantly higher in patients treated with NSPT alone than those treated with NSPT + Nd:YAG laser therapy. Among patients that underwent NSPT + laser therapy in both groups, periodontal parameters and serum IL-1β, and MMP-9 levels were comparable at 3-months follow-up. NSPT + Nd:YAG laser therapy may be more effective in reducing periodontal inflammation and serum IL-1β and MMP-9 levels in patients with and without CAD than NSPT alone. Lasers Surg. Med. 48:929-935, 2016. © 2016 Wiley Periodicals, Inc. © 2016 Wiley Periodicals, Inc.

First "glass" education: telementored cardiac ultrasonography using Google Glass- a pilot study.

PubMed

Russell, Patrick M; Mallin, Michael; Youngquist, Scott T; Cotton, Jennifer; Aboul-Hosn, Nael; Dawson, Matt

2014-11-01

The objective of this study was to determine the feasibility of telementored instruction in bedside ultrasonography (US) using Google Glass. The authors sought to examine whether first-time US users could obtain adequate parasternal long axis (PSLA) views to approximate ejection fraction (EF) using Google Glass telementoring. This was a prospective, randomized, single-blinded study. Eighteen second-year medical students were randomized into three groups and tasked with obtaining PSLA cardiac imaging. Group A received real-time telementored education through Google Glass via Google Hangout from a remotely located expert. Group B received bedside education from the same expert. Group C represented the control and received no instruction. Each subject was given 3 minutes to obtain a best PSLA cardiac imaging using a portable GE Vscan. Image clips obtained by each subject were stored. A second expert, blinded to instructional mode, evaluated images for adequacy and assigned an image quality rating on a 0 to 10 scale. Group A was able to obtain adequate images six out of six times (100%) with a median image quality rating of 7.5 (interquartile range [IQR] = 6 to 10) out of 10. Group B was also able to obtain adequate views six out of six times (100%), with a median image quality rating of 8 (IQR = 7 to 9). Group C was able to obtain adequate views one out of six times (17%), with a median image quality of 0 (IQR = 0 to 2). There were no statistically significant differences between Group A and Group B in the achievement of adequate images for E-point septal separation measurement or in image quality. In this pilot/feasibility study, novice US users were able to obtain adequate imaging to determine a healthy patient's EF through telementored education using Google Glass. These preliminary data suggest telementoring as an adequate means of medical education in bedside US. This conclusion will need to be validated with larger, more powerful studies including evaluation of pathologic findings and varying body habitus among models. © 2014 by the Society for Academic Emergency Medicine.

Intravitreal triamcinolone with transpupillary therapy for subfoveal choroidal neovascularization in age related macular degeneration. A randomized controlled pilot study [ISRCTN74123635

PubMed Central

Agurto-Rivera, Ricardo; Diaz-Rubio, Jose; Torres-Bernal, Luis; Macky, Tamer A; Colina-Luquez, Juner; Papa-Oliva, Gabriela; Jager, Rama D; Martinez-Jardon, Susana; Fromow-Guerra, Jans; Quiroz-Mercado, Hugo

2005-01-01

Background To assess the effect of intravitreal triamcinolone acetonide (iTA) as an adjunctive treatment to transpupillary therapy (TTT) for new subfoveal choroidal neovascular membranes (CNV) in age-related macular degeneration (AMD). Methods This prospective randomized controlled pilot study comprised 26 patients scheduled to receive TTT, due to either absent indications for photodynamic therapy or financial issues. Patients were assigned into; Group A (n = 14) received TTT alone and Group B (n = 12) received iTA (4 mg) followed by TTT within one week. Follow ups were at 2 weeks, and 1, 3 and 6 months for; best-corrected visual acuity (BCVA) by ETDRS chart at 4 meters, intraocular pressures (IOP), fluorescein angiography (FAG), and central foveal thickness by optical coherence tomography (OCT). Results All 26 patients completed 6 months of follow ups. The average age for both groups was 74 years. Occult CNV formed 64% and 41%; classis/predominately classic 21% and 16.6%; and minimally classic 15% and 42.4% of group A and B respectively. At baseline; the mean BCVA was 0.045 for group A and 0.04 for group B; mean CNV size was 6.15 disc diameter (DD) and 2.44 DD; mean OCT foveal thickness was 513 um and 411 um for group A and B respectively with no statistical differences (P = 0.8, 0.07, and 0.19). At six months the proportion of patients gained ≥ 1 lines was 14% and 25% (P = 0.136) and stabilization was 86% and 66% (P = 0.336); the mean size of the CNV was 5.63 DD and 2.67 DD (P = 0.162); rate of CNV closure was 64% and 83% (P = 0.275); and the mean OCT central foveal thickness was 516.36 um and 453.67 um (P = 0.341), for group A and B respectively. Conclusion The use of iTA as an adjunctive to TTT for new subfoveal CNV in AMD showed a tendency towards better functional results. However due to the small sample size of the study a statistically significant results could not be reached. PMID:16309554

Comparison of the effects of mirror therapy and electromyography-triggered neuromuscular stimulation on hand functions in stroke patients: a pilot study.

PubMed

Amasyali, Saliha Y; Yaliman, Ayşe

2016-12-01

To determine the effectiveness of mirror therapy and electromyography (EMG)-triggered neuromuscular stimulation on improvement of functions of the upper extremity in patients with subacute stroke in comparison with conventional therapy as well as to evaluate the advantage of each treatment over another, we conducted a prospective, randomized, and controlled trial involving 24 patients with ischemic stroke. The mean age and mean time since stroke of the patients were 58.79±11.49 years and 5.25±2.25 months. Patients were assigned randomly to a mirror therapy group (MT group, n=9), which consisted of therapy with a mirror box 5 days/week, 30 min/day, for 3 weeks, an electrostimulation group (ES group, n=7), which consisted of therapy with EMG-triggered stimulation (EMG-stim) of similar duration and frequency of treatment as the MT group, and a control group (n=8). All the groups received conventional physiotherapy for the same period as the MT group. Patients in the MT group practiced their therapy at home after supervised sessions. The Fugl-Meyer scores of the upper extremity, grip force, wrist extension, and Box and Block Test were evaluated at baseline, after treatment, and at 3 months after the treatment. All of these measures were evaluated by a blinded researcher. We found that there was no significant improvement in wrist extension range and grip force in control group. The MT and EMG-stim were effective in increasing the Fugl-Meyer motor scale for upper extremity (MT group: P<0.01), increasing wrist extension range, grip force, and hand dexterity determined by the Box and Block Test (MT group and ES group P<0.05). Furthermore, hand skills were increased significantly in the MT group compared with the ES group at the follow-up assessment (P<0.05). This pilot study suggested that MT was more efficient in improving motor performance than physiotherapy alone. Also, MT may be more useful in improving the hand skills compared with EMG-stim. We assume that this difference might be related to the feasibility of maintenance of MT at home.

Review and Analysis of Publication Trends over Three Decades in Three High Impact Medicine Journals.

PubMed

Ivanov, Alexander; Kaczkowska, Beata A; Khan, Saadat A; Ho, Jean; Tavakol, Morteza; Prasad, Ashok; Bhumireddy, Geetha; Beall, Allan F; Klem, Igor; Mehta, Parag; Briggs, William M; Sacchi, Terrence J; Heitner, John F

2017-01-01

Over the past three decades, industry sponsored research expanded in the United States. Financial incentives can lead to potential conflicts of interest (COI) resulting in underreporting of negative study results. We hypothesized that over the three decades, there would be an increase in: a) reporting of conflict of interest and source of funding; b) percentage of randomized control trials c) number of patients per study and d) industry funding. Original articles published in three calendar years (1988, 1998, and 2008) in The Lancet, New England Journal of Medicine and Journal of American Medical Association were collected. Studies were reviewed and investigational design categorized as prospective and retrospective clinical trials. Prospective trials were categorized into randomized or non-randomized and single-center or multi-center trials. Retrospective trials were categorized as registries, meta-analyses and other studies, mostly comprising of case reports or series. Study outcomes were categorized as positive or negative depending on whether the pre-specified hypothesis was met. Financial disclosures were researched for financial relationships and profit status, and accordingly categorized as government, non-profit or industry sponsored. Studies were assessed for reporting COI. 1,671 original articles were included in this analysis. Total number of published studies decreased by 17% from 1988 to 2008. Over 20 year period, the proportion of prospective randomized trials increased from 22 to 46% (p < 0.0001); whereas the proportion of prospective non-randomized trials decreased from 59% to 27% (p < 0.001). There was an increase in the percentage of prospective randomized multi-center trials from 11% to 41% (p < 0.001). Conversely, there was a reduction in non-randomized single-center trials from 47% to 10% (p < 0.001). Proportion of government funded studies remained constant, whereas industry funded studies more than doubled (17% to 40%; p < 0.0001). The number of studies with negative results more than doubled (10% to 22%; p<0.0001). While lack of funding disclosure decreased from 35% to 7%, COI reporting increased from 2% to 84% (p < 0.0001). Improved reporting of COI, clarity in financial sponsorship, increased publication of negative results in the setting of larger and better designed clinical trials represents a positive step forward in the scientific publications, despite the higher percentage of industry funded studies.

A Randomized Prospective Trial Comparing Paravertebral Block and General Anesthesia for Operative Treatment of Breast Cancer

DTIC Science & Technology

2001-10-01

block the anesthetic of choice for operative treatment of breast cancer. To test this hypothesis we proposed a prospective randomized clinical trial ...coordinators. Months 4-6. Status: Complete The study’s existing part-time Clinical Trial Coordinator, Mr. John Arbo, was enlisted full-time in June...of full-time Clinical Trial Coordinator for Mount Sinai. ■ Poster presentation by Mount Sinai staff of study goals and methods at a Department of

Prone versus supine position in mechanically ventilated children: a pilot study.

PubMed

Sawhney, Ashu; Kumar, Nirmal; Sreenivas, Vishnubhatla; Gupta, Sangeeta; Tyagi, Vineet; Puliyel, Jacob M

2005-05-01

It is known that mechanically ventilated patients in the prone position have improved oxygenation compared with those supine. We did a prospective, randomized, controlled trial to evaluate the effect of prone position during mechanical ventilation, on survival in critically ill children. Forty-two children needing mechanical ventilation for various illnesses were randomized to receive initial ventilation for four hours prone or supine by drawing lots. Initial severity of illness and blood gases in all children were noted. In a crossover design, after the initial four hours the children were turned over and ventilated in the alternate posture for an hour. Oxygenation parameters and mean airway pressures were noted at one hour, four hours, and five hours. Mortality, duration of ventilation, and the above parameters were compared in the two groups. Initial PRISM scores were similar in the two groups. Mortality in the prone group was less than in the supine group. The odds ratio of mortality was 0.20 (95% CI 0.05-0.75). Duration of ventilation was similar in the two groups. The oxygenation index was significantly lower in the prone group at one, four, and five hours after onset of ventilation. Prone position in the first few hours of ventilation significantly improves gas exchange and oxygenation, reduces the mean airway pressures required to ventilate children, and may cause significant improvement in survival. Our study protocol allowed ventilator settings to be changed as needed during ventilation.

Encouraging the installation of rollover protective structures in New York State: the design of a social marketing intervention.

PubMed

Sorensen, Julie A; May, John; Ostby-Malling, Ronne; Lehmen, Tom; Strand, John; Stenlund, Hans; Weinehall, Lars; Einehall, Lars W; Emmelin, Maria

2008-11-01

Increasing the percentage of rollover protective structure (ROPS) equipped tractors has been the focus of many agricultural safety campaigns. Traditionally efforts have attempted to persuade farmers through education or community awareness interventions. These efforts have lead to marginal change. In response, a social marketing approach was tested as a means for increasing interest in ROPS retrofitting in New York. An initial phone survey was conducted with a random sample of New York farmers to identify a potential target population. Following target selection, in-depth interviews were conducted to isolate barriers and motivators to retrofitting. This information was used to develop message prototypes which were tested in small focus group discussions. Selected and revised messages, as well as various other incentives developed in response to feedback from interviews, were then tested in a prospective, quasi-randomized controlled trial. Small crop and livestock farms were selected as the intervention target since they represent 86% of New York farms with none or only one ROPS protected tractor. Barriers to retrofitting which were identified in interviews were: 1) constant exposures normalize risk, 2) risk is modeled by significant others and 3) safety in general and retrofitting in particular requires too much time and money. The piloting of ROPS incentives led to a marked increase in ROPS sales in New York. Social Marketing provides a promising framework for the design of agricultural injury prevention programs. The potential implications for other health initiatives seeking to promote behaviour change are also discussed.

Does the cholinesterase inhibitor, donepezil, benefit both declarative and non-declarative processes in mild to moderate Alzheimer's disease?

PubMed

Winstein, Carolee J; Bentzen, Kirk R; Boyd, Lara; Schneider, Lon S

2007-07-01

Previous research suggests separate neural networks for implicit (non-declarative) and explicit (declarative) memory processes. A core cognitive impairment in mild to moderate Alzheimer's disease (AD) is a pronounced declarative memory and learning deficit with relative preservation of non-declarative memory. Cholinesterase inhibitors has been purported to enhance cognitive function, and previous clinical trials consistently showed that donepezil, a reversible inhibitor of acetylcholinesterase (AChE), led to statistically significant improvements in cognition and patient function. This prospective pilot study is a randomized, double blind, placebo-controlled clinical trial investigating 10 patients with AD. Our purpose was to examine the relationship between declarative and non-declarative capability with particular emphasis on implicit sequence learning. Patients were assessed at baseline and again at 4-weeks. After participants' baseline data were obtained, each was double-blindly randomized to one of two groups: donepezil or placebo. At baseline participants were tested with two outcome measures (Serial Reaction Time Task, Alzheimer's Disease Assessment Scale-Cognitive Subscale). Participants were given either 5 mg donepezil or an identically appearing placebo to be taken nightly for 4 weeks (28 tablets), and then retested. The donepezil group demonstrated a greater likelihood of increases in both non-declarative and declarative processes. The placebo group was mixed without clearly definable trends or patterns. When the data were examined for coincidental changes in the two outcome measures together they are suggestive of a benefit from donepezil treatment for non-declarative and declarative processes.

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.

USE OF NEUROFEEDBACK AND MINDFULNESS TO ENHANCE RESPONSE TO HYPNOSIS TREATMENT IN INDIVIDUALS WITH MULTIPLE SCLEROSIS: Results From a Pilot Randomized Clinical Trial.

PubMed

Jensen, Mark P; Battalio, Samuel L; Chan, Joy F; Edwards, Karlyn A; Day, Melissa A; Sherlin, Leslie H; Ehde, Dawn M

2018-01-01

This pilot study evaluated the possibility that 2 interventions hypothesized to increase slower brain oscillations (e.g., theta) may enhance the efficacy of hypnosis treatment, given evidence that hypnotic responding is associated with slower brain oscillations. Thirty-two individuals with multiple sclerosis and chronic pain, fatigue, or both, were randomly assigned to 1 of 2 interventions thought to increase slow wave activity (mindfulness meditation or neurofeedback training) or no enhancing intervention, and then given 5 sessions of self-hypnosis training targeting their presenting symptoms. The findings supported the potential for both neurofeedback and mindfulness to enhance response to hypnosis treatment. Research using larger sample sizes to determine the generalizability of these findings is warranted.

Brief mindfulness-based therapy for chronic tension-type headache: a randomized controlled pilot study.

PubMed

Cathcart, Stuart; Galatis, Nicola; Immink, Maarten; Proeve, Michael; Petkov, John

2014-01-01

Mindfulness-based therapy (MBT) has been demonstrated to be effective for reducing chronic pain symptoms; however, the use of MBT for Chronic Tension-Type Headache (CTH) exclusively has to date not been examined. Typically, MBT for chronic pain has involved an 8-week program based on Mindfulness Based Stress Reduction. Recent research suggests briefer mindfulness-based treatments may be effective for chronic pain. To conduct a pilot study into the efficacy of brief MBT for CTH. We conducted a randomized controlled trial of a brief (6-session, 3-week) MBT for CTH. Results indicated a significant decrease in headache frequency and an increase in the mindfulness facet of Observe in the treatment but not wait-list control group. Brief MBT may be an effective intervention for CTH.

Factors associated with malaria microscopy diagnostic performance following a pilot quality-assurance programme in health facilities in malaria low-transmission areas of Kenya, 2014.

PubMed

Odhiambo, Fredrick; Buff, Ann M; Moranga, Collins; Moseti, Caroline M; Wesongah, Jesca Okwara; Lowther, Sara A; Arvelo, Wences; Galgalo, Tura; Achia, Thomas O; Roka, Zeinab G; Boru, Waqo; Chepkurui, Lily; Ogutu, Bernhards; Wanja, Elizabeth

2017-09-13

Malaria accounts for ~21% of outpatient visits annually in Kenya; prompt and accurate malaria diagnosis is critical to ensure proper treatment. In 2013, formal malaria microscopy refresher training for microscopists and a pilot quality-assurance (QA) programme for malaria diagnostics were independently implemented to improve malaria microscopy diagnosis in malaria low-transmission areas of Kenya. A study was conducted to identify factors associated with malaria microscopy performance in the same areas. From March to April 2014, a cross-sectional survey was conducted in 42 public health facilities; 21 were QA-pilot facilities. In each facility, 18 malaria thick blood slides archived during January-February 2014 were selected by simple random sampling. Each malaria slide was re-examined by two expert microscopists masked to health-facility results. Expert results were used as the reference for microscopy performance measures. Logistic regression with specific random effects modelling was performed to identify factors associated with accurate malaria microscopy diagnosis. Of 756 malaria slides collected, 204 (27%) were read as positive by health-facility microscopists and 103 (14%) as positive by experts. Overall, 93% of slide results from QA-pilot facilities were concordant with expert reference compared to 77% in non-QA pilot facilities (p < 0.001). Recently trained microscopists in QA-pilot facilities performed better on microscopy performance measures with 97% sensitivity and 100% specificity compared to those in non-QA pilot facilities (69% sensitivity; 93% specificity; p < 0.01). The overall inter-reader agreement between QA-pilot facilities and experts was κ = 0.80 (95% CI 0.74-0.88) compared to κ = 0.35 (95% CI 0.24-0.46) between non-QA pilot facilities and experts (p < 0.001). In adjusted multivariable logistic regression analysis, recent microscopy refresher training (prevalence ratio [PR] = 13.8; 95% CI 4.6-41.4), ≥5 years of work experience (PR = 3.8; 95% CI 1.5-9.9), and pilot QA programme participation (PR = 4.3; 95% CI 1.0-11.0) were significantly associated with accurate malaria diagnosis. Microscopists who had recently completed refresher training and worked in a QA-pilot facility performed the best overall. The QA programme and formal microscopy refresher training should be systematically implemented together to improve parasitological diagnosis of malaria by microscopy in Kenya.

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,…

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…

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…

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…

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.

Determining the impact of a new physiotherapist-led primary care model for back pain: protocol for a pilot cluster randomized controlled trial.

PubMed

Miller, Jordan; Barber, David; Donnelly, Catherine; French, Simon; Green, Michael; Hill, Jonathan; MacDermid, Joy; Marsh, Jacquelyn; Norman, Kathleen; Richardson, Julie; Taljaard, Monica; Wideman, Timothy; Cooper, Lynn; McPhee, Colleen

2017-11-09

Back pain is a leading contributor to disability, healthcare costs, and lost work. Family physicians are the most common first point of contact in the healthcare system for people with back pain, but physiotherapists (PTs) may be able to support the primary care team through evidence-based primary care. A cluster randomized trial is needed to determine the clinical, health system, and societal impact of a primary care model that integrates physiotherapists at the first visit for people with back pain. Prior to conducting a future fully powered cluster randomized trial, we need to demonstrate feasibility of the methods. Therefore, the purpose of this pilot study will be to: 1) Determine feasibility of patient recruitment, assessment procedures, and retention. 2) Determine the feasibility of training and implementation of a new PT-led primary care model for low back pain (LBP) 3) Explore the perspectives of patients and healthcare providers (HCPs) related to their experiences and attitudes towards the new service delivery model, barriers/facilitators to implementation, perceived satisfaction, perceived value, and impact on clinic processes and patient outcomes. This pilot cluster randomized controlled trial will enroll four sites and randomize them to implement a new PT-led primary care model for back pain or a usual physician-led primary care model. All adults booking a primary care visit for back pain will be invited to participate. Feasibility outcomes will include: recruitment and retention rates, completeness of assessment data, PT training participation and confidence after training, and PT treatment fidelity. Secondary outcomes will include the clinical, health system, cost, and process outcomes planned for the future fully powered cluster trial. Results will be analyzed and reported descriptively and qualitatively. To explore perspectives of both HCPs and patients, we will conduct semi-structured qualitative interviews with patients and focus groups with HCPs from participants in the PT-led primary care sites. If this pilot demonstrates feasibility, a fully powered trial will provide evidence that has the potential to transform primary care for back pain. The full trial will inform future service design, whether these models should be more widely implemented, and training agendas. ClinicalTrials.gov, NCT03320148 . Submitted for registration on 17 September 2017.

Results of the promoting effective advance care planning for elders (PEACE) randomized pilot study.

PubMed

Radwany, Steven M; Hazelett, Susan E; Allen, Kyle R; Kropp, Denise J; Ertle, Denise; Albanese, Teresa H; Fosnight, Susan M; Moore, Pamela S

2014-04-01

The specific aim of the PEACE pilot study was to determine the feasibility of a fully powered study to test the effectiveness of an in-home geriatrics/palliative care interdisciplinary care management intervention for improving measures of utilization, quality of care, and quality of life in enrollees of Ohio's community-based long-term care Medicaid waiver program, PASSPORT. This was a randomized pilot study (n=40 intervention [IG], n=40 usual care) involving new enrollees into PASSPORT who were >60 years old. This was an in-home interdisciplinary chronic illness care management intervention by PASSPORT care managers collaborating with a hospital-based geriatrics/palliative care specialist team and the consumer's primary care physician. This pilot was not powered to test hypotheses; instead, it was hypothesis generating. Primary outcomes measured symptom control, mood, decision making, spirituality, and quality of life. Little difference was seen in primary outcomes; however, utilization favored the IG. At 12 months, the IG had fewer hospital visits (50% vs. 55%, P=0.65) and fewer nursing facility admissions (22.5% vs. 32.5%, P=0.32). Using hospital-based specialists interfacing with a community agency to provide a team-based approach to care of consumers with chronic illnesses was found to be feasible. Lack of change in symptom control or quality of life outcome measures may be related to the tools used, as these were validated in populations closer to the end of life. Data from this pilot study will be used to calculate the sample size needed for a fully powered trial.

Internet-based implementation of non-pharmacological interventions of the "people getting a grip on arthritis" educational program: an international online knowledge translation randomized controlled trial design protocol.

PubMed

Brosseau, Lucie; Wells, George; Brooks-Lineker, Sydney; Bennell, Kim; Sherrington, Cathie; Briggs, Andrew; Sturnieks, Daina; King, Judy; Thomas, Roanne; Egan, Mary; Loew, Laurianne; De Angelis, Gino; Casimiro, Lynn; Toupin April, Karine; Cavallo, Sabrina; Bell, Mary; Ahmed, Rukhsana; Coyle, Doug; Poitras, Stéphane; Smith, Christine; Pugh, Arlanna; Rahman, Prinon

2015-02-03

Rheumatoid arthritis (RA) affects 2.1% of the Australian population (1.5% males; 2.6% females), with the highest prevalence from ages 55 to over 75 years (4.4-6.1%). In Canada, RA affects approximately 0.9% of adults, and within 30 years that is expected to increase to 1.3%. With an aging population and a greater number of individuals with modifiable risk factors for chronic diseases, such as arthritis, there is an urgent need for co-care management of arthritic conditions. The increasing trend and present shifts in the health services and policy sectors suggest that digital information delivery is becoming more prominent. Therefore, it is necessary to further investigate the use of online resources for RA information delivery. The objective is to examine the effect of implementing an online program provided to patients with RA, the People Getting a Grip on Arthritis for RA (PGrip-RA) program, using information communication technologies (ie, Facebook and emails) in combination with arthritis health care professional support and electronic educational pamphlets. We believe this can serve as a useful and economical method of knowledge translation (KT). This KT randomized controlled trial will use a prospective randomized open-label blinded-endpoint design to compare four different intervention approaches of the PGrip-RA program to a control group receiving general electronic educational pamphlets self-management in RA via email. Depending on group allocation, links to the Arthritis Society PGrip-RA material will be provided either through Facebook or by email. One group will receive feedback online from trained health care professionals. The intervention period is 6 weeks. Participants will have access to the Internet-based material after the completion of the baseline questionnaires until the final follow-up questionnaire at 6 months. We will invite 396 patients from Canadian and Australian Arthritis Consumers' Associations to participate using online recruitment. This study will build on a pilot study using Facebook, which revealed promising effects of knowledge acquisition/integration of the evidence-based self-management PGrip educational program. The use of online techniques to disseminate knowledge provides an opportunity to reduce health care costs by facilitating self-management of people with arthritis. Study design strengths include the incorporation of randomization and allocation concealment to ensure internal validity. To avoid intergroup contamination, the Facebook group page security settings will be set to "closed", thus allowing only invited participants to access it. Study limitations include the lack of participant blinding due to the characteristics of this KT randomized controlled trial and a potential bias of recruiting patients only online, though this was proven effective in the previous pilot study. Australian New Zealand Clinical Trials Registry ACTRN12614000397617; http://www.anzctr.org.au/TrialSearch.aspx (Archived by WebCite at http://www.webcitation.org/6PrP0kQf8).

Internet-Based Implementation of Non-Pharmacological Interventions of the "People Getting a Grip on Arthritis" Educational Program: An International Online Knowledge Translation Randomized Controlled Trial Design Protocol

PubMed Central

Thomas, Roanne; De Angelis, Gino

2015-01-01

Background Rheumatoid arthritis (RA) affects 2.1% of the Australian population (1.5% males; 2.6% females), with the highest prevalence from ages 55 to over 75 years (4.4-6.1%). In Canada, RA affects approximately 0.9% of adults, and within 30 years that is expected to increase to 1.3%. With an aging population and a greater number of individuals with modifiable risk factors for chronic diseases, such as arthritis, there is an urgent need for co-care management of arthritic conditions. The increasing trend and present shifts in the health services and policy sectors suggest that digital information delivery is becoming more prominent. Therefore, it is necessary to further investigate the use of online resources for RA information delivery. Objective The objective is to examine the effect of implementing an online program provided to patients with RA, the People Getting a Grip on Arthritis for RA (PGrip-RA) program, using information communication technologies (ie, Facebook and emails) in combination with arthritis health care professional support and electronic educational pamphlets. We believe this can serve as a useful and economical method of knowledge translation (KT). Methods This KT randomized controlled trial will use a prospective randomized open-label blinded-endpoint design to compare four different intervention approaches of the PGrip-RA program to a control group receiving general electronic educational pamphlets self-management in RA via email. Depending on group allocation, links to the Arthritis Society PGrip-RA material will be provided either through Facebook or by email. One group will receive feedback online from trained health care professionals. The intervention period is 6 weeks. Participants will have access to the Internet-based material after the completion of the baseline questionnaires until the final follow-up questionnaire at 6 months. We will invite 396 patients from Canadian and Australian Arthritis Consumers’ Associations to participate using online recruitment. Results This study will build on a pilot study using Facebook, which revealed promising effects of knowledge acquisition/integration of the evidence-based self-management PGrip educational program. Conclusions The use of online techniques to disseminate knowledge provides an opportunity to reduce health care costs by facilitating self-management of people with arthritis. Study design strengths include the incorporation of randomization and allocation concealment to ensure internal validity. To avoid intergroup contamination, the Facebook group page security settings will be set to “closed”, thus allowing only invited participants to access it. Study limitations include the lack of participant blinding due to the characteristics of this KT randomized controlled trial and a potential bias of recruiting patients only online, though this was proven effective in the previous pilot study. Trial Registration Australian New Zealand Clinical Trials Registry ACTRN12614000397617; http://www.anzctr.org.au/TrialSearch.aspx (Archived by WebCite at http://www.webcitation.org/6PrP0kQf8). PMID:25648515

Brief Report: Pilot Randomized Controlled Trial of Reciprocal Imitation Training for Teaching Elicited and Spontaneous Imitation to Children with Autism

ERIC Educational Resources Information Center

Ingersoll, Brooke

2010-01-01

Children with autism exhibit significant deficits in imitation skills. Reciprocal Imitation Training (RIT), a naturalistic imitation intervention, was developed to teach young children with autism to imitate during play. This study used a randomized controlled trial to evaluate the efficacy of RIT on elicited and spontaneous imitation skills in 21…

Parent Training with High-Risk Immigrant Chinese Families: A Pilot Group Randomized Trial Yielding Practice-Based Evidence

ERIC Educational Resources Information Center

Lau, Anna S.; Fung, Joey J.; Ho, Lorinda Y.; Liu, Lisa L.; Gudino, Omar G.

2011-01-01

We studied the efficacy and implementation outcomes of a culturally responsive parent training (PT) program. Fifty-four Chinese American parents participated in a wait-list controlled group randomized trial (32 immediate treatment, 22 delayed treatment) of a 14-week intervention designed to address the needs of high-risk immigrant families.…

Stepped and Standard Care for Childhood Trauma: A Pilot Randomized Clinical Trial

ERIC Educational Resources Information Center

Salloum, Alison; Small, Brent J.; Robst, John; Scheeringa, Michael S.; Cohen, Judith A.; Storch, Eric A.

2017-01-01

Objective: This study explored the feasibility of stepped care trauma-focused cognitive behavioral therapy (SC-TF-CBT) relative to TF-CBT with children (aged 8--12). Method: Children (N = 33) with post-traumatic stress symptoms (PTSS) were randomly assigned (2:1) to SC-TF-CBT or TF-CBT. SC-TF-CBT consisted of Step 1, parent-led therapist-assisted…

Preliminary Evaluation of a Tier 2 Mathematics Intervention for First-Grade Students: Using a Theory of Change to Guide Formative Evaluation Activities

ERIC Educational Resources Information Center

Clarke, Ben; Doabler, Christian T.; Strand Cary, Mari; Kosty, Derek; Baker, Scott; Fien, Hank; Smolkowski, Keith

2014-01-01

This pilot study examined the efficacy of a Tier 2 first-grade mathematics intervention program targeting whole-number understanding for students at risk in mathematics. The study used a randomized block design. Students (N = 89) were randomly assigned to treatment (Fusion) or control (standard district practice) conditions. Measures of…

Augmenting Antidepressant Medication Treatment of Depressed Women with Emotionally Focused Therapy for Couples: A Randomized Pilot Study

ERIC Educational Resources Information Center

Denton, Wayne H.; Wittenborn, Andrea K.; Golden, Robert N.

2012-01-01

This is the first study to evaluate adding emotionally focused therapy for couples (EFT) to antidepressant medication in the treatment of women with major depressive disorder and comorbid relationship discord. Twenty-four women and their male partners were randomized to 6 months of medication management alone (MM) or MM augmented with EFT (MM +…

Programmed Physical Exertion in Recovery From Sports-Related Concussion: A Randomized Pilot Study.

PubMed

Maerlender, Arthur; Rieman, Wanda; Lichtenstein, Jonathan; Condiracci, C

2015-01-01

Although no data exist, general practice recommends only rest following concussion. This randomized clinical trial found that programmed physical exertion during recovery produced no significant differences in recovery time between groups of participants. However, high levels of exertion were deleterious. This study provides initial evidence that moderate physical activity is a safe replacement behavior during recovery.

A Double-Blind Randomized Pilot Study Comparing Quetiapine and Divalproex for Adolescent Mania

ERIC Educational Resources Information Center

Delbello, Melissa P.; Kowatch, Robert A.; Adler, Caleb M.; Stanford, Kevin E.; Welge, Jeffrey A.; Barzman, Drew H.; Nelson, Erik; Strakowski, Stephen M.

2006-01-01

Objective: To determine the comparative efficacy of quetiapine and divalproex for the treatment of adolescent mania. Method: Fifty adolescents (ages 12-18 years) with bipolar I disorder, manic or mixed episode, were randomized to quetiapine (400-600 mg/day) or divalproex (serum level 80-120 [micro]g/mL) for 28 days for this double-blind study,…

Is Homeopathy Effective for Hot Flashes and Other Estrogen-Withdrawl Symptoms in Breast Cancer Survivors? A Preliminary Randomized Controlled Trial

DTIC Science & Technology

2001-09-01

symptoms for more than 100 years. To carry out a pilot study to determine whether there is evidence that homeopathy is an effective treatment to improve the...one month, with at least 3 hot flashes per day. Subjects have been randomized to one of three treatment arms: classical homeopathy , a combination

A process for Decision-making after Pilot and feasibility Trials (ADePT): development following a feasibility study of a complex intervention for pelvic organ prolapse

PubMed Central

2013-01-01

Background Current Medical Research Council (MRC) guidance on complex interventions advocates pilot trials and feasibility studies as part of a phased approach to the development, testing, and evaluation of healthcare interventions. In this paper we discuss the results of a recent feasibility study and pilot trial for a randomized controlled trial (RCT) of pelvic floor muscle training for prolapse (ClinicalTrials.gov: NCT01136889). The ways in which researchers decide to respond to the results of feasibility work may have significant repercussions for both the nature and degree of tension between internal and external validity in a definitive trial. Methods We used methodological issues to classify and analyze the problems that arose in the feasibility study. Four centers participated with the aim of randomizing 50 women. Women were eligible if they had prolapse of any type, of stage I to IV, and had a pessary successfully fitted. Postal questionnaires were administered at baseline, 6 months, and 7 months post-randomization. After identifying problems arising within the pilot study we then sought to locate potential solutions that might minimize the trade-off between a subsequent explanatory versus pragmatic trial. Results The feasibility study pointed to significant potential problems in relation to participant recruitment, features of the intervention, acceptability of the intervention to participants, and outcome measurement. Finding minimal evidence to support our decision-making regarding the transition from feasibility work to a trial, we developed a systematic process (A process for Decision-making after Pilot and feasibility Trials (ADePT)) which we subsequently used as a guide. The process sought to: 1) encourage the systematic identification and appraisal of problems and potential solutions; 2) improve the transparency of decision-making processes; and 3) reveal the tensions that exist between pragmatic and explanatory choices. Conclusions We have developed a process that may aid researchers in their attempt to identify the most appropriate solutions to problems identified within future pilot and feasibility RCTs. The process includes three key steps: a decision about the type of problem, the identification of all solutions (whether addressed within the intervention, trial design or clinical context), and a systematic appraisal of these solutions. PMID:24160371

[PROtocol-based MObilizaTION on intensive care units : Design of a cluster randomized pilot study].

PubMed

Nydahl, P; Diers, A; Günther, U; Haastert, B; Hesse, S; Kerschensteiner, C; Klarmann, S; Köpke, S

2017-10-12

Despite convincing evidence for early mobilization of patients on intensive care units (ICU), implementation in practice is limited. Protocols for early mobilization, including in- and exclusion criteria, assessments, safety criteria, and step schemes may increase the rate of implementation and mobilization. Patients (population) on ICUs with a protocol for early mobilization (intervention), compared to patients on ICUs without protocol (control), will be more frequently mobilized (outcome). A multicenter, stepped-wedge, cluster-randomized pilot study is presented. Five ICUs will receive an adapted, interprofessional protocol for early mobilization in randomized order. Before and after implementation, mobilization of ICU patients will be evaluated by randomized monthly one-day point prevalence surveys. Primary outcome is the percentage of patients mobilized out of bed, operationalized as a score of ≥3 on the ICU Mobility Scale. Secondary outcome parameters will be presence and/or length of mechanical ventilation, delirium, stay on ICU and in hospital, barriers to early mobilization, adverse events, and process parameters as identified barriers, used strategies, and adaptions to local conditions. Exploratory evaluation of study feasibility and estimation of effect sizes as the basis for a future explanatory study.

Is ginger effective for the treatment of irritable bowel syndrome? A double blind randomized controlled pilot trial.

PubMed

van Tilburg, Miranda A L; Palsson, Olafur S; Ringel, Yehuda; Whitehead, William E

2014-02-01

Ginger is one of the most commonly used herbal medicines for irritable bowel syndrome (IBS) but no data exists about its effectiveness. Double blind randomized controlled trial. University of North Carolina, Chapel Hill, North Carolina, USA. Forty-five IBS patients were randomly assigned to three groups: placebo, 1g of ginger, and 2g of ginger daily for 28 days. The IBS severity scale (IBS-SS) was administered, as well as adequate relief of symptoms scale. A responder was defined as having at least 25% reduction in IBS-SS post-treatment. There were 57.1% responders to placebo, 46.7% to 1g and 33.3% to 2g of ginger. Adequate relief was reported by 53.3% on placebo and 53.3% in both ginger groups combined. Side effects were mild and reported by 35.7% in the placebo and 16.7% in the ginger groups. This double blind randomized controlled pilot study suggests ginger is well tolerated but did not perform better than placebo. Larger trials are needed before any definitive conclusions can be drawn. Copyright © 2014 Elsevier Ltd. All rights reserved.

A Multicenter, Prospective, Randomized Controlled Trial Evaluating the Efficacy of Rectal Diclofenac and Sublingual Nitroglycerin as a Combined Prophylactic Treatment for Post-ERCP Pancreatitis.

PubMed

Tomoda, Takeshi; Kato, Hironari; Mizukawa, Sho; Muro, Shinichiro; Akimoto, Yutaka; Uchida, Daisuke; Matsumoto, Kazuyuki; Yamamoto, Naoki; Horiguchi, Shigeru; Tsutsumi, Koichiro; Okada, Hiroyuki

2016-01-01

Acute pancreatitis is the major complication of endoscopic retrograde cholangiopancreatography (ERCP). A preliminary research suggested that the administration of nonsteroidal anti-inflammatory drugs (NSAIDs) with nitroglycerin might reduce the incidence of post-ERCP pancreatitis (PEP) more effectively than NSAIDs alone. We conduct a two-arm, multicenter, prospective, randomized, superiority trial to evaluate the additional effect of nitroglycerin for prevention of PEP. A total of 900 patients randomly receive 50 mg diclofenac suppository either alone or with 5 mg isosorbide dinitrate sublingual tablet. The primary endpoint is the occurrence of PEP. This study will clarify whether NSAIDs plus nitroglycerin can prevent PEP.

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.

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.

Hospital cost analysis of a prospective, randomized trial of early vs interval appendectomy for perforated appendicitis in children.

PubMed

Myers, Adrianne L; Williams, Regan F; Giles, Kim; Waters, Teresa M; Eubanks, James W; Hixson, S Douglas; Huang, Eunice Y; Langham, Max R; Blakely, Martin L

2012-04-01

The methods of surgical care for children with perforated appendicitis are controversial. Some surgeons prefer early appendectomy; others prefer initial nonoperative management followed by interval appendectomy. Determining which of these two therapies is most cost-effective was the goal of this study. We conducted a prospective, randomized trial in children with a preoperative diagnosis of perforated appendicitis. Patients were randomized to early or interval appendectomy. Overall hospital costs were extracted from the hospital's internal cost accounting system and the two treatment groups were compared using an intention-to-treat analysis. Nonparametric data were reported as median ± standard deviation (or range) and compared using a Wilcoxon rank sum test. One hundred thirty-one patients were randomized to either early (n = 64) or interval (n = 67) appendectomy. Hospital charges and costs were significantly lower in patients randomized to early appendectomy. Total median hospital costs were $17,450 (range $7,020 to $55,993) for patients treated with early appendectomy vs $22,518 (range $4,722 to $135,338) for those in the interval appendectomy group. Median hospital costs more than doubled in patients who experienced an adverse event ($15,245 vs $35,391, p < 0.0001). Unplanned readmissions also increased costs significantly and were more frequent in patients randomized to interval appendectomy. In a prospective randomized trial, hospital charges and costs were significantly lower for early appendectomy when compared with interval appendectomy. The increased costs were related primarily to the significant increase in adverse events, including unplanned readmissions, seen in the interval appendectomy group. Copyright © 2012. Published by Elsevier Inc.

Measurement of human pilot dynamic characteristics in flight simulation

NASA Technical Reports Server (NTRS)

Reedy, James T.

1987-01-01

Fast Fourier Transform (FFT) and Least Square Error (LSE) estimation techniques were applied to the problem of identifying pilot-vehicle dynamic characteristics in flight simulation. A brief investigation of the effects of noise, input bandwidth and system delay upon the FFT and LSE techniques was undertaken using synthetic data. Data from a piloted simulation conducted at NASA Ames Research Center was then analyzed. The simulation was performed in the NASA Ames Research Center Variable Stability CH-47B helicopter operating in fixed-basis simulator mode. The piloting task consisted of maintaining the simulated vehicle over a moving hover pad whose motion was described by a random-appearing sum of sinusoids. The two test subjects used a head-down, color cathode ray tube (CRT) display for guidance and control information. Test configurations differed in the number of axes being controlled by the pilot (longitudinal only versus longitudinal and lateral), and in the presence or absence of an important display indicator called an 'acceleration ball'. A number of different pilot-vehicle transfer functions were measured, and where appropriate, qualitatively compared with theoretical pilot- vehicle models. Some indirect evidence suggesting pursuit behavior on the part of the test subjects is discussed.

Modeling the Impact of Control on the Attractiveness of Risk in a Prospect Theory Framework

PubMed Central

Young, Diana L.; Goodie, Adam S.; Hall, Daniel B.

2010-01-01

Many decisions involve a degree of personal control over event outcomes, which is exerted through one’s knowledge or skill. In three experiments we investigated differences in decision making between prospects based on a) the outcome of random events and b) the outcome of events characterized by control. In Experiment 1, participants estimated certainty equivalents (CEs) for bets based on either random events or the correctness of their answers to U.S. state population questions across the probability spectrum. In Experiment 2, participants estimated CEs for bets based on random events, answers to U.S. state population questions, or answers to questions about 2007 NCAA football game results. Experiment 3 extended the same procedure as Experiment 1 using a within-subjects design. We modeled data from all experiments in a prospect theory framework to establish psychological mechanisms underlying decision behavior. Participants weighted the probabilities associated with bets characterized by control so as to reflect greater risk attractiveness relative to bets based on random events, as evidenced by more elevated weighting functions under conditions of control. This research elucidates possible cognitive mechanisms behind increased risk taking for decisions characterized by control, and implications for various literatures are discussed. PMID:21278906

Modeling the Impact of Control on the Attractiveness of Risk in a Prospect Theory Framework.

PubMed

Young, Diana L; Goodie, Adam S; Hall, Daniel B

2011-01-01

Many decisions involve a degree of personal control over event outcomes, which is exerted through one's knowledge or skill. In three experiments we investigated differences in decision making between prospects based on a) the outcome of random events and b) the outcome of events characterized by control. In Experiment 1, participants estimated certainty equivalents (CEs) for bets based on either random events or the correctness of their answers to U.S. state population questions across the probability spectrum. In Experiment 2, participants estimated CEs for bets based on random events, answers to U.S. state population questions, or answers to questions about 2007 NCAA football game results. Experiment 3 extended the same procedure as Experiment 1 using a within-subjects design. We modeled data from all experiments in a prospect theory framework to establish psychological mechanisms underlying decision behavior. Participants weighted the probabilities associated with bets characterized by control so as to reflect greater risk attractiveness relative to bets based on random events, as evidenced by more elevated weighting functions under conditions of control. This research elucidates possible cognitive mechanisms behind increased risk taking for decisions characterized by control, and implications for various literatures are discussed.

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.

Visualizing Patterns of Drug Prescriptions with EventFlow: A Pilot Study of Asthma Medications in the Military Health System

DTIC Science & Technology

2013-06-01

1 Visualizing Patterns of Drug Prescriptions with EventFlow: A Pilot Study of Asthma Medications in the...asthmatics within the Military Health System (MHS). Visualizing the patterns of asthma medication use surrounding a LABA prescription is a quick way to...random sample of 100 asthma patients under age 65 with a new LABA prescription from January 1, 2006-March 1, 2010 in MHS healthcare claims. Analysis was

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.

[EEG-correlates of pilots' functional condition in simulated flight dynamics].

PubMed

Kiroy, V N; Aslanyan, E V; Bakhtin, O M; Minyaeva, N R; Lazurenko, D M

2015-01-01

The spectral characteristics of the EEG recorded on two professional pilots in the simulator TU-154 aircraft in flight dynamics, including takeoff, landing and horizontal flight (in particular during difficult conditions) were analyzed. EEG recording was made with frequency band 0.1-70 Hz continuously from 15 electrodes. The EEG recordings were evaluated using analysis of variance and discriminant analysis. Statistical significant of the identified differences and the influence of the main factors and their interactions were evaluated using Greenhouse - Gaiser corrections. It was shown that the spectral characteristics of the EEG are highly informative features of the state of the pilots, reflecting the different flight phases. High validity ofthe differences including individual characteristic, indicates their non-random nature and the possibility of constructing a system of pilots' state control during all phases of flight, based on EEG features.

Cosmic Radiation and Cataracts in Airline Pilots

NASA Astrophysics Data System (ADS)

Rafnsson, V.; Olafsdottir, E.; Hrafnkelsson, J.; de Angelis, G.; Sasaki, H.; Arnarson, A.; Jonasson, F.

Nuclear cataracts have been associated with ionising radiation exposure in previous studies. A population based case-control study on airline pilots has been performed to investigate whether employment as a commercial pilot and consequent exposure to cosmic radiation were associated to lens opacification, when adjusted for known risk factors for cataracts. Cases of opacification of the ocular lens were found in surveys among pilots and a random sample of the Icelandic population. Altogether 445 male subjects underwent a detailed eye examination and answered a questionnaire. Information from the airline company on the 79 pilots employment time, annual hours flown per aircraft type, the timetables and the flight profiles made calculation of individual cumulated radiation dose (mSv) possible. Lens opacification were classified and graded according to WHO simplified cataracts grading system using slit lamp. The odds ratio from logistic regression of nuclear cataracts risk among cases and controls was 3.02 (95% CI 1.44 to 6.35) for pilots compared with non-pilots, adjusted for age, smoking and sunbathing habits, whereas that of cortical cataracts risk among cases and controls was lower than unity (non significant) for pilots compared with non-pilots in a logistic regression analysis adjusted for same factors. Length of employment as a pilot and cumulated radiation dose (mSv) were significantly related to the risk of nuclear cataracts. So the association between radiation exposure of pilots and the risk of nuclear cataracts, adjusted for age, smoking and sunbathing habits, indicates that cosmic radiation may be cause of nuclear cataract among commercial pilots.

[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.

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

Behavioral Weight Loss for the Management of Menopausal Hot Flashes: A Pilot Study

PubMed Central

Thurston, Rebecca C.; Ewing, Linda J.; Low, Carissa A.; Christie, Aimee J.; Levine, Michele D.

2014-01-01

Objective Although adiposity has been considered protective against hot flashes, newer data suggest positive relations between flashes and adiposity. No studies have been specifically designed to test whether weight loss reduces hot flashes. This pilot study aimed to evaluate the feasibility, acceptability, and initial efficacy of behavioral weight loss to reduce hot flashes. Methods Forty overweight/obese women with hot flashes (≥4/day) were randomized to a behavioral weight loss intervention or to wait list control. Hot flashes were assessed pre- and post-intervention via physiologic monitor, diary, and questionnaire. Comparisons of changes in hot flashes and anthropometrics between conditions were tested via Wilcoxon tests. Results Study retention (83%) and intervention satisfaction (93.8%) were high. Most women (74.1%) reported that hot flash reduction was a main motivator to lose weight. Women randomized to the weight loss intervention lost more weight (-8.86 kg) than did women randomized to control (+0.23 kg, p<.0001). Women randomized to weight loss also showed greater reductions in questionnaire-reported hot flashes (2-week hot flashes: −63.0) than did women in the control (−28.0, p=.03), a difference not demonstrated in other hot flash measures. Reductions in weight and hot flashes were significantly correlated (e.g., r=.47, p=.006). Conclusions This pilot study showed a behavioral weight loss program to be feasible, acceptable, and effective in producing weight loss among overweight/obese women with hot flashes. Findings indicate the importance of a larger study designed to test behavioral weight loss for hot flash reduction. Hot flash management could motivate women to engage in this health-promoting behavior. PMID:24977456

Chewing gum for the treatment of postoperative nausea and vomiting: a pilot randomized controlled trial.

PubMed

Darvall, J N; Handscombe, M; Leslie, K

2017-01-01

A novel treatment, chewing gum, may be non-inferior to ondansetron in inhibiting postoperative nausea and vomiting (PONV) in female patients after laparoscopic or breast surgery. In this pilot study, we tested the feasibility of a large randomized controlled trial. We randomized 94 female patients undergoing laparoscopic or breast surgery to ondansetron 4 mg i.v. or chewing gum if PONV was experienced in the postanaesthesia care unit (PACU). The primary outcome was full resolution of PONV, with non-inferiority defined as a difference between groups of <15% in a per protocol analysis. Secondary outcomes were PACU stay duration, anti-emetic rescue use, and acceptability of anti-emetic treatment. The feasibility of implementing the protocol in a larger trial was assessed. Postoperative nausea and vomiting in the PACU occurred in 13 (28%) ondansetron patients and 15 (31%) chewing gum patients (P=0.75). Three chewing gum patients could not chew gum when they developed PONV. On a per protocol basis, full resolution of PONV occurred in five of 13 (39%) ondansetron vs nine of 12 (75%) chewing gum patients [risk difference 37% (6.3-67%), P=0.07]. There was no difference in secondary outcomes between groups. Recruitment was satisfactory, the protocol was acceptable to anaesthetists and nurses, and data collection was complete. In this pilot trial, chewing gum was not inferior to ondansetron for treatment of PONV after general anaesthesia for laparoscopic or breast surgery in female patients. Our findings demonstrate the feasibility of a larger, multicentred randomized controlled trial to investigate this novel therapy. Australian New Zealand Clinical Trials Registry: ACTRN12615001327572. © The Author 2016. Published by Oxford University Press on behalf of the British Journal of Anaesthesia. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

Accelerated Titration of Oxytocin in Nulliparous Women with Labour Dystocia: Results of the ACTION Pilot Randomized Controlled Trial.

PubMed

Dy, Jessica; Rainey, Jenna; Walker, Mark C; Fraser, William; Smith, Graeme N; White, Ruth Rennicks; Waddell, Patti; Janoudi, Ghayath; Corsi, Daniel J; Wei, Shu Qin

2018-06-01

The primary objective was to determine the feasibility of a large RCT assessing the effectiveness of an accelerated oxytocin titration (AOT) protocol compared with a standard gradual oxytocin titration (GOT) in reducing the risk of CS in nulliparous women diagnosed with dystocia in the first stage of labour. The secondary objective was to obtain preliminary data on the safety and efficacy of the foregoing AOT protocol. This was a multicentre, double-masked, parallel-group pilot RCT. This study was conducted in three Canadian birthing centres. A total of 79 term nulliparous women carrying a singleton pregnancy in spontaneous labour, with a diagnosis of labour dystocia, were randomized to receive either GOT (initial dose 2 mU/min with increments of 2 mU/min) or AOT (initial dose 4 mU/min with increments of 4 mU/min), in a 1:1 ratio. An intention-to-treat analysis was applied. A total of 252 women were screened and approached, 137 (54.4%) consented, and 79 (31.3%) were randomized. Overall protocol adherence was 76 of 79 (96.2%). Of the women randomized, 10 (25.6%) allocated to GOT had a CS compared with six (15.0%) allocated to AOT (Fisher exact test P = 0.27). This pilot study demonstrated that a large, multicentre RCT is not only feasible, but also necessary to assess the effectiveness and safety of an AOT protocol for labour augmentation with regard to CS rate and indicators of maternal and perinatal morbidities. Copyright © 2018 Society of Obstetricians and Gynaecologists of Canada. Published by Elsevier Inc. All rights reserved.

Behavioral weight loss for the management of menopausal hot flashes: a pilot study.

PubMed

Thurston, Rebecca C; Ewing, Linda J; Low, Carissa A; Christie, Aimee J; Levine, Michele D

2015-01-01

Although adiposity has been considered to be protective against hot flashes, newer data suggest positive relationships between hot flashes and adiposity. No studies have been specifically designed to test whether weight loss reduces hot flashes. This pilot study aimed to evaluate the feasibility, acceptability, and initial efficacy of behavioral weight loss in reducing hot flashes. Forty overweight or obese women with hot flashes (≥ 4 hot flashes/d) were randomized to either behavioral weight loss intervention or wait-list control. Hot flashes were assessed before and after intervention via physiologic monitoring, diary, and questionnaire. Comparisons of changes in hot flashes and anthropometrics between conditions were performed via Wilcoxon tests. Study retention (83%) and intervention satisfaction (93.8%) were high. Most women (74.1%) reported that hot flash reduction was a major motivator for losing weight. Women randomized to the weight loss intervention lost more weight (-8.86 kg) than did women randomized to control (+0.23 kg; P < 0.0001). Women randomized to weight loss also showed greater reductions in questionnaire-reported hot flashes (2-wk hot flashes, -63.0) than did women in the control group (-28.0; P = 0.03)-a difference not demonstrated in other hot flash measures. Reductions in weight and hot flashes were significantly correlated (eg, r = 0.47, P = 0.006). This pilot study shows a behavioral weight loss program that is feasible, acceptable, and effective in producing weight loss among overweight or obese women with hot flashes. Findings indicate the importance of a larger study designed to test behavioral weight loss for hot flash reduction. Hot flash management could motivate women to engage in this health-promoting behavior.

A Pilot Randomized Clinical Trial of Intermittent Occlusion Therapy Liquid Crystal Glasses versus Traditional Patching for Treatment of Moderate Unilateral Amblyopia

PubMed Central

Wang, Jingyun; Neely, Daniel E.; Galli, Jay; Schliesser, Joshua; Graves, April; Damarjian, Tina G.; Kovarik, Jessica; Bowsher, James; Smith, Heather A.; Donaldson, Dana; Haider, Kathryn M.; Roberts, Gavin J.; Sprunger, Derek T.; Plager, David A.

2017-01-01

INTRODUCTION This pilot study was designed to compare the effectiveness of intermittent occlusion therapy (IO-Therapy) using liquid crystal glasses versus continuous occlusion therapy using traditional adhesive patches for treating amblyopia. DESIGN A randomized controlled trial. Children 3–8 years of age with previously untreated, moderate, unilateral amblyopia (visual acuity of 20/40 to 20/100 in the amblyopic eye) were enrolled. Amblyopia was associated with strabismus, anisometropia, or both. All subjects had worn optimal refractive correction (if needed) for at least 12 weeks without improvement. Subjects were randomized into two treatment groups: a 4-hour IO-Therapy Group with liquid crystal glasses (Amblyz™), set at 30-second opaque/transparent intervals (occluded 50% of wear time) or a 2-hour continuous Patching Group (occluded 100% of wear time). For each patient, visual acuity was measured with the ATS-HOTV method before and after 12 weeks of treatment. RESULTS At the conclusion of the first 12 week-treatment interval, data from 34 patients were available for analysis. Amblyopic eye visual acuity improvement from baseline was 0.15±0.12 (95% CI=0.09 to 0.15) logMAR in the IO-Therapy Group (N=19) and 0.15±0.11 (95% CI=0.1 to 0.15) logMAR in the Patching Group (N=15). Improvements in both groups were significant. The difference between groups was not statistically significant (P=0.73). No adverse effects were reported. CONCLUSION In this pilot study, IO-Therapy with Amblyz liquid crystal glasses is not inferior to adhesive patching and is a promising alternative treatment for children 3–8 years of age with moderate amblyopia. A larger randomized clinical trial is needed to confirm results in future. PMID:27418249

Targeting functional fitness, hearing and health-related quality of life in older adults with hearing loss: Walk, Talk 'n' Listen, study protocol for a pilot randomized controlled trial.

PubMed

Lambert, Justin; Ghadry-Tavi, Rouzbeh; Knuff, Kate; Jutras, Marc; Siever, Jodi; Mick, Paul; Roque, Carolyn; Jones, Gareth; Little, Jonathan; Miller, Harry; Van Bergen, Colin; Kurtz, Donna; Murphy, Mary Ann; Jones, Charlotte Ann

2017-01-28

Hearing loss (HL) is a disability associated with poorer health-related quality of life including an increased risk for loneliness, isolation, functional fitness declines, falls, hospitalization and premature mortality. The purpose of this pilot trial is to determine the feasibility and acceptability of a novel intervention to reduce loneliness, improve functional fitness, social connectedness, hearing and health-related quality of life in older adults with HL. This 10-week, single-blind, pilot randomized control trial (RCT) will include a convenience sample of ambulatory adults aged 65 years or older with self-reported HL. Following baseline assessments, participants will be randomized to either intervention (exercise, health education, socialization and group auditory rehabilitation (GAR)) or control (GAR only) groups. The intervention group will attend a local YMCA twice a week and the control group once a week. Intervention sessions will include 45 min of strengthening, balance and resistance exercises, 30 min of group walking at a self-selected pace and 60 min of interactive health education or GAR. The control group will attend 60-min GAR sessions. GAR sessions will include education about hearing, hearing technologies, enhancing communication skills, and psychosocial support. Pre-post trial data collection and measures will include: functional fitness (gait speed, 30-s Sit to Stand Test), hearing and health-related quality of life, loneliness, depression, social participation and social support. At trial end, feasibility (recruitment, randomization, retention, acceptability) and GAR will be evaluated. Despite evidence suggesting that HL is associated with declines in functional fitness, there are no studies aimed at addressing functional fitness declines associated with the disability of HL. This pilot trial will provide knowledge about the physical, mental and social impacts on health related to HL as a disability. This will inform the feasibility of a larger RCT and preliminary evidence about the initial effects of a novel, community-based, holistic intervention addressing both the negative psychosocial and functional physical effects of HL among older adults. ClinicalTrials.gov, NCT02662192 . Registered on 14 January 2016.

Combined electrical stimulation and exercise for swallow rehabilitation post-stroke: a pilot randomized control trial.

PubMed

Sproson, Lise; Pownall, Sue; Enderby, Pam; Freeman, Jenny

2018-03-01

Dysphagia is common after stroke, affecting up to 50% of patients initially. It can lead to post-stroke pneumonia, which causes 30% of stroke-related deaths, a longer hospital stay and poorer health outcomes. Dysphagia care post-stroke generally focuses on the management of symptoms, via modified oral intake textures and adapted posture, rather than direct physical rehabilitation of the swallowing function. Transcutaneous neuromuscular electrical stimulation (NMES) is a promising rehabilitation technology that can be used to stimulate swallowing; however, findings regarding efficacy have been conflicting. This pilot randomized controlled study involving three UK sites compared the efficacy of the Ampcare Effective Swallowing Protocol (ESP), combining NMES with swallow-strengthening exercises, with usual care in order to clarify evidence on NMES in the treatment of dysphagia post-stroke. A further objective was to pilot recruitment procedures and outcome measures in order to inform the design of a full-scale trial. Thirty patients were recruited and randomized into either (1) usual speech and language therapy dysphagia care; or (2) Ampcare ESP, receiving treatment 5 days/week for 4 weeks. Outcome measures included: the Functional Oral Intake Scale (FOIS), the Rosenbek Penetration-Aspiration Scale (PAS) and patient-reported outcomes (Swallow Related Quality of Life-SWAL-QOL). Thirty patients were recruited; 15 were randomized to the Ampcare ESP intervention arm and 15 to usual care. A greater proportion (75%, or 9/12) of patients receiving Ampcare ESP improved compared with 57% (or 8/14) of the usual-care group. Patients receiving Ampcare ESP also made clinically meaningful change (a comparative benefit of 1.5 on the FOIS, and on the PAS: 1.35 for diet and 0.3 for fluids) compared with usual care. The intervention group also reported much better outcome satisfaction. The pilot demonstrated successful recruitment, treatment safety and tolerability and clinically meaningful outcome improvements, justifying progression to a fully powered study. It also showed clinically meaningful treatment trends for the Ampcare ESP intervention. © 2017 Royal College of Speech and Language Therapists.

Value of information analysis optimizing future trial design from a pilot study on catheter securement devices.

PubMed

Tuffaha, Haitham W; Reynolds, Heather; Gordon, Louisa G; Rickard, Claire M; Scuffham, Paul A

2014-12-01

Value of information analysis has been proposed as an alternative to the standard hypothesis testing approach, which is based on type I and type II errors, in determining sample sizes for randomized clinical trials. However, in addition to sample size calculation, value of information analysis can optimize other aspects of research design such as possible comparator arms and alternative follow-up times, by considering trial designs that maximize the expected net benefit of research, which is the difference between the expected cost of the trial and the expected value of additional information. To apply value of information methods to the results of a pilot study on catheter securement devices to determine the optimal design of a future larger clinical trial. An economic evaluation was performed using data from a multi-arm randomized controlled pilot study comparing the efficacy of four types of catheter securement devices: standard polyurethane, tissue adhesive, bordered polyurethane and sutureless securement device. Probabilistic Monte Carlo simulation was used to characterize uncertainty surrounding the study results and to calculate the expected value of additional information. To guide the optimal future trial design, the expected costs and benefits of the alternative trial designs were estimated and compared. Analysis of the value of further information indicated that a randomized controlled trial on catheter securement devices is potentially worthwhile. Among the possible designs for the future trial, a four-arm study with 220 patients/arm would provide the highest expected net benefit corresponding to 130% return-on-investment. The initially considered design of 388 patients/arm, based on hypothesis testing calculations, would provide lower net benefit with return-on-investment of 79%. Cost-effectiveness and value of information analyses were based on the data from a single pilot trial which might affect the accuracy of our uncertainty estimation. Another limitation was that different follow-up durations for the larger trial were not evaluated. The value of information approach allows efficient trial design by maximizing the expected net benefit of additional research. This approach should be considered early in the design of randomized clinical trials. © The Author(s) 2014.

An observer-blinded randomized controlled pilot trial comparing localized immersion psoralen-ultraviolet A with localized narrowband ultraviolet B for the treatment of palmar hand eczema.

PubMed

Brass, D; Fouweather, T; Stocken, D D; Macdonald, C; Wilkinson, J; Lloyd, J; Farr, P M; Reynolds, N J; Hampton, P J

2017-12-13

Hand eczema is a common inflammatory dermatosis that causes significant patient morbidity. Previous studies comparing psoralen-ultraviolet A (PUVA) with narrowband ultraviolet B (NB-UVB) have been small, nonrandomized and retrospective. To conduct an observer-blinded randomized controlled pilot study using validated scoring criteria to compare immersion PUVA with NB-UVB for the treatment of chronic hand eczema unresponsive to topical steroids. Sixty patients with hand eczema unresponsive to clobetasol propionate 0·05% were randomized to receive either immersion PUVA or NB-UVB twice weekly for 12 weeks with assessments at intervals of 4 weeks. The primary outcome measure was the proportion of patients achieving 'clear' or 'almost clear' Physician's Global Assessment (PGA) response at 12 weeks. Secondary outcome measures included assessment of the modified Total Lesion and Symptom Score (mTLSS) and the Dermatology Life Quality index (DLQI). In both treatment arms, 23 patients completed the 12-week assessment for the primary outcome measure. In the PUVA group, five patients achieved 'clear' and eight 'almost clear' [intention-to-treat (ITT) response rate 43%]. In the NB-UVB group, two achieved 'clear' and five 'almost clear' (ITT response rate 23%). For the secondary outcomes, median mTLSS scores were similar between groups at baseline (PUVA 9·5, NB-UVB 9) and at 12 weeks (PUVA 3, NB-UVB 4). Changes in DLQI were similar, with improvements in both groups. In this randomized pilot trial recruitment was challenging. After randomization, there were acceptable levels of compliance and safety in each treatment schedule, but lower levels of retention. Using validated scoring systems - PGA, mTLSS and DLQI - as measures of treatment response, the trial demonstrated that both PUVA and NB-UVB reduced the severity of chronic palmar hand eczema. © 2017 British Association of Dermatologists.

Investigation of technology needs for avoiding helicopter pilot error related accidents

NASA Technical Reports Server (NTRS)

Chais, R. I.; Simpson, W. E.

1985-01-01

Pilot error which is cited as a cause or related factor in most rotorcraft accidents was examined. Pilot error related accidents in helicopters to identify areas in which new technology could reduce or eliminate the underlying causes of these human errors were investigated. The aircraft accident data base at the U.S. Army Safety Center was studied as the source of data on helicopter accidents. A randomly selected sample of 110 aircraft records were analyzed on a case-by-case basis to assess the nature of problems which need to be resolved and applicable technology implications. Six technology areas in which there appears to be a need for new or increased emphasis are identified.

Considering Culturally Relevant Parenting Practices in Intervention Development and Adaptation: A Randomized Controlled Trial of the Black Parenting Strengths and Strategies (BPSS) Program

ERIC Educational Resources Information Center

Coard, Stephanie I.; Foy-Watson, Shani; Zimmer, Catherine; Wallace, Amy

2007-01-01

A randomized prevention pilot trial compared caregivers who participated in the Black Parenting Strengths and Strategies (BPSS) Program with control caregivers. BPSS is a strengths- and culturally based parenting program designed to improve aspects of parenting associated with the early development of conduct problems and the promotion of social…

Random forests and stochastic gradient boosting for predicting tree canopy cover: Comparing tuning processes and model performance

Treesearch

Elizabeth A. Freeman; Gretchen G. Moisen; John W. Coulston; Barry T. (Ty) Wilson

2015-01-01

As part of the development of the 2011 National Land Cover Database (NLCD) tree canopy cover layer, a pilot project was launched to test the use of high-resolution photography coupled with extensive ancillary data to map the distribution of tree canopy cover over four study regions in the conterminous US. Two stochastic modeling techniques, random forests (RF...

APCAP--activated protein C in acute pancreatitis: a double-blind randomized human pilot trial.

PubMed

Pettilä, Ville; Kyhälä, Lea; Kylänpää, Marja-Leena; Leppäniemi, Ari; Tallgren, Minna; Markkola, Antti; Puolakkainen, Pauli; Repo, Heikki; Kemppainen, Esko

2010-01-01

Previous human studies have shown low activity of protein C (APC) in severe acute pancreatitis (SAP). This, together with the findings in animal models, suggests that activated protein C (APC) may protect against pancreatic injury and ameliorate the disease. We, therefore, evaluated its effect on multiple organ dysfunction (MOD) measured by the SOFA (Sequential Organ Failure Assessment) and on organ-failure-free days, and the safety of APC in SAP. A prospective double blind randomized pilot study was use. The study occurred in one university hospital tertiary intensive care unit (ICU) with eight beds. The patients were chosen according to the following inclusion criteria: 1) Those admitted to the hospital < 96 h from the onset of pain, 2) Those who had a three-fold increase in serum amylase over normal upper range or/and in whom computed tomography (CT) verification of SAP was noted, 3) Those who had one or more organ dysfunction (OD), and 4) Those in whom less than 48 hours had passed since their first OD. Of a total of 215 adult patients with SAP screened between June 2003 and August 2007, 158 fulfilled the study inclusion criteria. After exclusions 32 patients were randomized to the study. The intervention consisted of APC (N = 16) administered intravenously for 96 hours with a dose of 24 μg/kg/hour or placebo (N = 16) with a similar infusion rate. The sample size for the study was calculated according to the primary end-point: the change in SOFA during study drug infusion (Days 0 and 5). Comparisons between the study groups were performed using patient-related changes and calculation of difference in means (DIM, 95% CIs) and regarding categorical variables with Fisher's exact test. For all comparisons P < 0.05 was considered significant. No serious bleeding was detected clinically or by CT scans in either group. No significant difference in SOFA score change between the APC and placebo groups was found (difference in means (DIM) +2.3, 95% CI -0.7 to +5.3). Treatment with APC was associated with an increase in serum levels of both total and conjugated bilirubin. No differences in ventilator-free days, in renal replacement therapy-free days, in vasopressor-free days, or in days alive outside the hospital were detected. No serious bleeding or differences in the evolution of MOD were detected between APC and the placebo. Instead we found an increase in serum bilirubin in the APC group compared to the placebo group in patients with SAP. ClinicalTrials.gov NCT01017107.

A pilot randomized controlled trial comparing effectiveness of prism glasses, visual search training and standard care in hemianopia.

PubMed

Rowe, F J; Conroy, E J; Bedson, E; Cwiklinski, E; Drummond, A; García-Fiñana, M; Howard, C; Pollock, A; Shipman, T; Dodridge, C; MacIntosh, C; Johnson, S; Noonan, C; Barton, G; Sackley, C

2017-10-01

Pilot trial to compare prism therapy and visual search training, for homonymous hemianopia, to standard care (information only). Prospective, multicentre, parallel, single-blind, three-arm RCT across fifteen UK acute stroke units. Stroke survivors with homonymous hemianopia. Arm a (Fresnel prisms) for minimum 2 hours, 5 days per week over 6 weeks. Arm b (visual search training) for minimum 30 minutes, 5 days per week over 6 weeks. Arm c (standard care-information only). Adult stroke survivors (>18 years), stable hemianopia, visual acuity better than 0.5 logMAR, refractive error within ±5 dioptres, ability to read/understand English and provide consent. Primary outcomes were change in visual field area from baseline to 26 weeks and calculation of sample size for a definitive trial. Secondary measures included Rivermead Mobility Index, Visual Function Questionnaire 25/10, Nottingham Extended Activities of Daily Living, Euro Qual, Short Form-12 questionnaires and Radner reading ability. Measures were post-randomization at baseline and 6, 12 and 26 weeks. Randomization block lists stratified by site and partial/complete hemianopia. Allocations disclosed to patients. Primary outcome assessor blind to treatment allocation. Eighty-seven patients were recruited: 27-Fresnel prisms, 30-visual search training and 30-standard care; 69% male; mean age 69 years (SD 12). At 26 weeks, full results for 24, 24 and 22 patients, respectively, were compared to baseline. Sample size calculation for a definitive trial determined as 269 participants per arm for a 200 degree 2 visual field area change at 90% power. Non-significant relative change in area of visual field was 5%, 8% and 3.5%, respectively, for the three groups. Visual Function Questionnaire responses improved significantly from baseline to 26 weeks with visual search training (60 [SD 19] to 68.4 [SD 20]) compared to Fresnel prisms (68.5 [SD 16.4] to 68.2 [18.4]: 7% difference) and standard care (63.7 [SD 19.4] to 59.8 [SD 22.7]: 10% difference), P=.05. Related adverse events were common with Fresnel prisms (69.2%; typically headaches). No significant change occurred for area of visual field area across arms over follow-up. Visual search training had significant improvement in vision-related quality of life. Prism therapy produced adverse events in 69%. Visual search training results warrant further investigation. © 2016 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

Robot-assisted gait training in multiple sclerosis: a pilot randomized trial.

PubMed

Beer, S; Aschbacher, B; Manoglou, D; Gamper, E; Kool, J; Kesselring, J

2008-03-01

To evaluate feasibility and perform an explanatory analysis of the efficacy of robot-assisted gait training (RAGT) in MS patients with severe walking disabilities (Expanded Disability Status Scale [EDSS] 6.0-7.5) in a pilot trial. Prospective, randomized, controlled clinical trial comparing RAGT with conventional walking training (CWT) in a group of stable MS patients (n = 35) during an inpatient rehabilitation stay, 15 sessions over three weeks. All patients participated additionally in a multimodal rehabilitation program. The primary outcome measure was walking velocity and secondary measures were 6-min-walking distance, stride length and knee-extensor strength. All tests were performed by an external blinded assessor at baseline after three weeks and at follow-up after six months. Additionally, Extended Barthel Index (EBI) at entry and discharge was assessed (not blinded), and acceptance/convenience of RAGT rated by patients (Visual Analogue Scale [VAS]) was recorded. Nineteen patients were randomly allocated to RAGT and 16 patients to CWT. Groups were comparable at baseline. There were 5 drop-outs (2 related directly to treatment) in the RAGT group and 1 in the CWT group, leaving 14 RAGT patients and 15 CWT patients for final analysis. Acceptance and convenience of RAGT as rated by patients were high. Effect sizes were moderate to large, although not significant, for walking velocity (0.700, 95% CI -0.089 to 1.489), walking distance (0.401, 95% CI - 0.370 to 1.172) and knee-extensor strength (right: 1.105, 95% CI 0.278 to 1.932, left 0.650, 95% CI -0.135 to 1.436) favouring RAGT. Prepost within-group analysis revealed an increase of walking velocity, walking distance and knee-extensor strength in the RAGT group, whereas in CWT group only walking velocity was improved. In both groups outcome values returned to baseline at follow-up after six months (n = 23). Robot-assisted gait training is feasible and may be an effective therapeutic option in MS patients with severe walking disabilities. Effect size calculation and prepost analysis suggest a higher benefit on walking velocity and knee-extensor strength by RAGT compared to CWT. Due to several limitations, however, our results should be regarded as preliminary. Post hoc power calculation showed that two groups of 106 patients are needed to demonstrate a significant moderate effect size of 0.4 after three weeks of RAGT. Thus, further studies with a larger number of patients are needed to investigate the impact of this new treatment option in MS patients.

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

PubMed

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

2013-10-01

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

Long-term Clinical Outcomes of Cervical Disc Arthroplasty: A Prospective, Randomized, Controlled Trial.

PubMed

Sasso, Willa R; Smucker, Joseph D; Sasso, Maria P; Sasso, Rick C

2017-02-15

Prospective, randomized, single-center, clinical trial. To prospectively examine the 7- and 10-year outcomes of cervical arthroplasty to anterior cervical discectomy and fusion (ACDF). Degeneration of the cervical discs causing radiculopathy is a frequent source of surgical intervention, commonly treated with ACDF. Positive clinical outcomes are associated with arthrodesis techniques, yet there remains a long-term concern for adjacent segment change. Cervical disc arthroplasty has been designed to mitigate some of the challenges associated with arthrodesis whereas providing for a similar positive neurological outcome. As data has been collected from numerous prospective US FDA IDE trials, longer term outcomes regarding adjacent segment change may be examined. As part of an FDA IDE trial, a single center collected prospective outcomes data on 47 patients randomized in a 1:1 ratio to ACDF or arthroplasty. Success of both surgical interventions remained high at the 10-year interval. Both arthrodesis and arthroplasty demonstrated statistically significant improvements in neck disability index, visual analog scale neck and arm pain scores at all intervals including 7- and 10-year periods. Arthroplasty demonstrated an advantage in comparison to arthrodesis as measured by final 10-year NDI score (8 vs. 16, P = 0.0485). Patients requiring reoperation were higher in number in the arthrodesis cohort (32%) in comparison with arthroplasty (9%) (P = 0.055). At 7 and 10 years, cervical arthroplasty compares favorably with ACDF as defined by standard outcomes scores in a highly selected population with radiculopathy. 1.

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 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…

Effects of Increasing Hydrocortisone to 300 mg Per Day in the Treatment of Septic Shock: a Pilot Study.

PubMed

Hyvernat, Hervé; Barel, Rémy; Gentilhomme, Anne; Césari-Giordani, Jean François; Freche, Annie; Kaidomar, Michel; Goubaux, Bernard; Pradier, Christian; Dellamonica, Jean; Bernardin, Gilles

2016-11-01

The Surviving Sepsis Campaign guidelines recommend hydrocortisone in septic shock only when fluid resuscitation and vasopressors fail to restore hemodynamic stability. Hydrocortisone administration modalities are supported only by low-grade recommendations. Our main objective here was to determine differences in 28-day mortality between two low-dose hydrocortisone regimens for the treatment of septic shock. We performed a multicenter, prospective, randomized, double-blind, pilot study in four adult medical intensive care units. Patients presenting septic shock were rapidly administered one of two regimens of hydrocortisone, either a 50-mg intravenous bolus every 6 h during 7 days (200-mg group; n = 59) or a 100-mg initial bolus followed by a continuous infusion of 300 mg daily for 5 days (300-mg group; n = 63). Hydrocortisone was stopped abruptly at the end of treatment. There were no significant differences between the 200-mg and 300-mg groups as concerns 28-day mortality (respectively 52.5% vs. 44.4% [RR 0.84, 95% CI, 0.58-1.22, P = 0.47]), refractory shock incidence or delay from shock to vasopressor cessation. There were also no differences in adverse events between the groups. Shock relapse after hydrocortisone cessation was independent of hydrocortisone regimens, but it was associated with the persistence of infection and the use of etomidate. The resumption of hydrocortisone due to shock relapse was significantly more frequent in the 300-mg group. We found no differences in mortality or adverse events between the two hydrocortisone administration regimens. Shock relapse was significantly associated with the persistence of infection and the use of etomidate.

Effects of deep brain stimulation on rest tremor progression in early stage Parkinson disease.

PubMed

Hacker, Mallory L; DeLong, Mahlon R; Turchan, Maxim; Heusinkveld, Lauren E; Ostrem, Jill L; Molinari, Anna L; Currie, Amanda D; Konrad, Peter E; Davis, Thomas L; Phibbs, Fenna T; Hedera, Peter; Cannard, Kevin R; Drye, Lea T; Sternberg, Alice L; Shade, David M; Tonascia, James; Charles, David

2018-06-29

To evaluate whether the progression of individual motor features was influenced by early deep brain stimulation (DBS), a post hoc analysis of Unified Parkinson's Disease Rating Scale-III (UPDRS-III) score (after a 7-day washout) was conducted from the 2-year DBS in early Parkinson disease (PD) pilot trial dataset. The prospective pilot trial enrolled patients with PD aged 50-75 years, treated with PD medications for 6 months-4 years, and no history of dyskinesia or other motor fluctuations, who were randomized to receive optimal drug therapy (ODT) or DBS plus ODT (DBS + ODT). At baseline and 6, 12, 18, and 24 months, all patients stopped all PD therapy for 1 week (medication and stimulation, if applicable). UPDRS-III "off" item scores were compared between the ODT and DBS + ODT groups (n = 28); items with significant between-group differences were analyzed further. UPDRS-III "off" rest tremor score change from baseline to 24 months was worse in patients receiving ODT vs DBS + ODT ( p = 0.002). Rest tremor slopes from baseline to 24 months favored DBS + ODT both "off" and "on" therapy ( p < 0.001, p = 0.003, respectively). More ODT patients developed new rest tremor in previously unaffected limbs than those receiving DBS + ODT ( p = 0.001). These results suggest the possibility that DBS in early PD may slow rest tremor progression. Future investigation in a larger cohort is needed, and these findings will be tested in the Food and Drug Administration-approved, phase III, pivotal, multicenter clinical trial evaluating DBS in early PD. This study provides Class II evidence that for patients with early PD, DBS may slow the progression of rest tremor. © 2018 American Academy of Neurology.

Five-months-postoperative neuropsychological outcome from a pilot prospective randomized clinical trial of thalamic deep brain stimulation for Tourette syndrome.

PubMed

Schoenberg, Mike R; Maddux, Brian N; Riley, David E; Whitney, Christina M; Ogrocki, Paula K; Gould, Deborah; Maciunas, Robert J

2015-02-01

Tourette syndrome (TS) is a neuropsychiatric disorder presenting with motor and/or sonic tics associated with frontostriatal dysfunction. This study provided pilot data of the neuropsychological safety of bilateral thalamic deep brain stimulation (DBS) to treat medication-refractory TS in adults. This study used a repeated-measures design with pretest and 3-month follow-up from start of continuous bilateral DBS. Five male patients underwent DBS surgery for medically refractory TS. Repeated-measures ANOVA was used to evaluate for any change in neuropsychological test scores, employing a false discovery rate. Outcome measures included 14 neuropsychological tests assessing psychomotor speed, attention, memory, language, visuoconstructional, and executive functions, as well as subjective mood ratings of depression and anxiety. Average age was 28.2 years (SD = 7.5) with 12-17 years of education. Participants were disabled by tics, with a tic frequency of 50-80 per minute before surgery. At baseline, subjects' cognitive function was generally average, although mild deficits in sequencing and verbal fluency were present, as were clinically mild obsessive-compulsive symptoms. At 3 months of continuous DBS (5 months after implantation), 3 of 5 participants had clinical reductions in motor and sonic tics. Cognitive scores generally remained stable, but declines of moderate to large effect size (Cohen's d > 0.6) in verbal fluency, visual immediate memory, and reaction time were observed. Fewer symptoms of depression and anxiety, as well as fewer obsessions and compulsions, were reported after 3 months of continuous high-frequency DBS. Bilateral centromedian-parafascicular thalamic DBS for medically refractory TS shows promise for treatment of medically refractory TS without marked neuropsychological morbidity. Symptoms of depression and anxiety improved. © 2014 International Neuromodulation Society.

Using tablet-based technology in patient education about systemic therapy options for early-stage breast cancer: a pilot study.

PubMed

Morgan, E R; Laing, K; McCarthy, J; McCrate, F; Seal, M D

2015-10-01

Patient education in early-stage breast cancer has been shown to improve patient well-being and quality of life, but it poses a challenge given the increasingly complex regimens and time constraints in clinical practice. Technology-aided teaching in the clinic could help to improve the understanding of adjuvant systemic therapy for patients. In this prospective pilot study, we used a clinician-administered, tablet-based teaching aid to teach patients with early-stage breast cancer about adjuvant systemic therapy. Participation was offered to newly diagnosed patients with early-stage breast cancer presenting for their first medical oncology visit at a provincial cancer centre. Participants were shown a tablet-based presentation describing procedures, rationales, risks, and benefits of adjuvant systemic therapy as an adjunct to a discussion with the medical oncologist. After the clinic visit, participants completed a questionnaire measuring satisfaction with the visit and knowledge of the treatment plan discussed. The 25 patients recruited for the study had a mean age of 57 years. An offer of upfront chemotherapy alone was made to 12 participants (48%), chemotherapy with trastuzumab to 4 (16%), and hormonal therapy to 9 (36%). Correct answers to all questions related to treatment knowledge were given by 22 patients (88%). Satisfaction with the clinic visit was high (mean satisfaction score: 4.53 ± 0.1 of a possible 5). We found that a tablet-based presentation about adjuvant systemic therapy was satisfactory to patients with early-stage breast cancer and that knowledge retention after the clinic visit was high. Tablet-based teaching could be a feasible and effective way of educating patients in the breast oncology clinic and warrants further investigation in randomized studies.

Beneficial effects of a Coriolus versicolor-based vaginal gel on cervical epithelization, vaginal microbiota and vaginal health: a pilot study in asymptomatic women.

PubMed

Palacios, Santiago; Losa, Fernando; Dexeus, Damián; Cortés, Javier

2017-03-16

To assess the effect of a 12-day treatment using a vaginal gel based on niosomes containing hyaluronic acid, ß-glucan, alpha-glucan oligosaccharide, Coriolus versicolor, Asian centella, Azadirachta indica and Aloe vera on vaginal microbiota, cervical epithelization and vaginal health. Open-label, prospective pilot study conducted in asymptomatic women in daily practice. Cervical epithelization was evaluated by colposcopy using an ectopy epithelization score (from 5: no ectopy to 1: severe ectopy and bleeding), vaginal microbiota using the VaginaStatus-Diagnostic test (Instiüt für Mikroökologie, Herborn, Germany) and further rated by the investigator using a 5-point Liker scale (from 5: normal to 1: very severe deterioration in which all evaluated species were altered), and vaginal health using the Vaginal Health Index. In 21 women, a positive effect to improve epithelization of the cervical mucosa, with a mean score of 4.42 at the final visit as compared to 3.09 at baseline (P < 0.0001) (43% improvement). In 10 women, there was a trend of improving of vaginal microbiota status, with a mean score of 4.0 at the final visit vs. 3.3 at baseline (P = NS) (21.2% improvement). In 11 women, the Vaginal Health Index increased from 19.0 at baseline to 22.3 at the final visit (P = 0.007). The concentration of Lactobacillus spp. increased 54.5% of women and pH decreased from 4.32 to 4.09. These encouraging preliminary results provide the basis for designing a randomized controlled study, and for potential use in human papilloma virus infection. ISRCTN77955077 . Registration date: February 15, 2017. Retrospectively registered.

Quality of life and side effects in patients with actinic keratosis treated with ingenol mebutate: a pilot study.

PubMed

Jubert-Esteve, E; Del Pozo-Hernando, L J; Izquierdo-Herce, N; Bauzá-Alonso, A; Martín-Santiago, A; Jones-Caballero, M

2015-10-01

Actinic keratosis (AK) lesions are in situ squamous cell carcinoma. These lesions have a low risk of progressing to invasive disease but significant impact on patients' quality of life (QoL). The aim of this study was to assess QoL and side effects in patients with AK receiving treatment with ingenol mebutate. This was a prospective, non-randomized pilot study carried out in Spain. The target population was adults with a clinical diagnosis of AK affecting any part of the body. Outcomes were assessed on the basis of a QoL questionnaire (Skindex-29), local skin response, the Treatment Satisfaction Questionnaire for Medication (TSQM 1.4), and clinical response. A total of 19 patients were studied. Most of the participants were men (89.5%) and mean age was 76.2 years. After treatment with ingenol mebutate, significant improvement was observed in the Skindex-29 subscales relating to symptom severity (P=.041), the patients' emotional state (P=.026), and in the overall score (P=.014). Erythema, crusting, and flaking or scaling were the local skin responses with highest median score (2.0 in all 3 cases). Imiquimod 5% and ingenol mebutate achieved higher median scores for effectiveness and global satisfaction than any other previous treatments (as measured by TSQM 1.4). In the patients' assessment of convenience, ingenol mebutate had a higher median score than previous treatments. Over half of the patients (52.6%) had an improvement of at least 75% at month 3. QoL in patients with AK improves after treatment with ingenol mebutate. The presence of side effects did not affect QoL or patient satisfaction with treatment. Copyright © 2015 Elsevier España, S.L.U. and AEDV. All rights reserved.

Comparison of Hemostasis Times With a Kaolin-Based Hemostatic Pad (QuikClot Radial) vs Mechanical Compression (TR Band) Following Transradial Access: A Pilot Prospective Study.

PubMed

Roberts, Jonathan S; Niu, Jianli; Pastor-Cervantes, Juan A

2017-10-01

Hemostasis following transradial access (TRA) is usually achieved by mechanical compression. We investigated use of the QuikClot Radial hemostasis pad (Z-Medica) compared with the TR Band (Terumo Medical) to shorten hemostasis after TRA. Thirty patients undergoing TRA coronary angiography and/or percutaneous coronary intervention were randomized into three cohorts post TRA: 10 patients received mechanical compression with the TR Band, 10 patients received 30 min of compression with the QuikClot Radial pad, and 10 patients received 60 min of compression with the QuikClot Radial pad. Times to hemostasis and access-site complications were recorded. Radial artery patency was evaluated 1 hour after hemostasis by the reverse Barbeau's test. There were no differences in patient characteristics, mean dose of heparin (7117 ± 1054 IU), or mean activated clotting time value (210 ± 50 sec) at the end of procedure among the three groups. Successful hemostasis was achieved in 100% of patients with both the 30-min and 60-min compression groups using the QuikClot pad. Hemostasis failure occurred in 50% of patients when the TR Band was initially weaned at the protocol-driven time (40 min after sheath removal). Mean compression time for hemostasis with the TR Band was 149.4 min compared with 30.7 min and 60.9 min for the 30-min and 60-min QuikClot groups, respectively. No radial artery occlusion occurred in any subject at the end of the study. Use of the QuikClot Radial pad following TRA in this pilot trial significantly shortened hemostasis times when compared with the TR Band, with no increased complications noted.

Development and pilot testing of a decision aid for surrogates of patients with prolonged mechanical ventilation

PubMed Central

Cox, Christopher E.; Lewis, Carmen L.; Hanson, Laura C.; Hough, Catherine L.; Kahn, Jeremy M.; White, Douglas B.; Song, Mi-Kyung; Tulsky, James A.; Carson, Shannon S.

2013-01-01

Objective Shared decision making is inadequate in intensive care units (ICUs). Decision aids can improve decision making quality, though their role in an ICU setting is unclear. We aimed to develop and pilot test a decision aid for shared decision makers of patients undergoing prolonged mechanical ventilation. Setting ICUs at three medical centers. Subjects 53 surrogate decision makers and 58 physicians. Design and interventions We developed the decision aid using defined methodological guidelines. After an iterative revision process, formative cognitive testing was performed among surrogate-physician dyads. Next, we compared the decision aid to usual care control in a prospective, before/after design study. Measurements and main results Primary outcomes were physician-surrogate discordance for expected patient survival, comprehension of relevant medical information, and the quality of communication. Compared to control, the intervention group had lower surrogate-physician discordance (7 [10] vs 43 [21]), greater comprehension (11.4 [0.7] vs 6.1 [3.7]), and improved quality of communication (8.7 [1.3] vs 8.4 [1.3]) (all p<0.05) post-intervention. Hospital costs were lower in the intervention group ($110,609 vs $178,618; p=0.044); mortality did not differ by group (38% vs 50%, p=0.95). 94% of surrogates and 100% of physicians reported that the decision aid was useful in decision making. Conclusion We developed a prolonged mechanical ventilation decision aid that is feasible, acceptable, and associated with both improved decision making quality and less resource utilization. Further evaluation using a randomized controlled trial design is needed to evaluate the decision aid's effect on long-term patient and surrogate outcomes. PMID:22635048

Neuroplastic Response After Radiation Therapy for Pediatric Brain Tumors: A Pilot Study

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

Armstrong, Carol L., E-mail: armstrongc@email.chop.edu; Fisher, Michael J.; Li, Yimei

Purpose: Clinically effective measurement of cognitive toxicity from photon radiation therapy (XRT) should be accurate, sensitive, and specific. This pilot study tested translational findings on phasic changes in children's memory systems that are sensitive and insensitive to toxic XRT effects to identify a possible neuroplastic effect. Methods and Materials: Memory processes were prospectively tested before XRT and at 3 later time points up to 2 years in 35 children with mixed primary brain tumors who had not experienced recurrence. Memory processes were verbal-semantic, visual-semantic, and visual-perceptual, including accuracy, speed to recall, encoding, retrieval, and recognition. The mixed-effects model included time (tomore » estimate slope), covariates (age, tumor locus, XRT field, and medications) as fixed effects, and individual random intercepts. A sensitivity analysis examined the influence of XRT dose to the hippocampi on memory. Results: Retrieval from long-term verbal-semantic memory declined 2 months after completing XRT, as seen in adults, and was lowest at 1 year, which was delayed in comparison with adults. Double dissociation from visual-perceptual memory at baseline and 2 months was found, consistent with adults. Recovery was demonstrated 2 years after XRT. Patterns were unchanged when dose to hippocampus was included in the model. Conclusions: Verbal and semantic long-term retrieval is specifically sensitive to XRT-related cognitive dysfunction, without effect on visual-perceptual memory. Children reached nadir in XRT-sensitive memory 1 year after XRT and recovered by 2 years, which is later than that observed in adults. The protracted period of post-XRT injury may represent the maturation of the human hippocampus and white matter into late adolescence.« less

Medi-Port Pilot Randomized Controlled Trial

ClinicalTrials.gov

2017-12-29

Actively Undergoing Cancer Treatment; 4-9 Years of Age; At Least 1 Month From Diagnosis; Able to Speak and Understand English; Presenting to Clinic for at Least a 2nd Subcutaneous Port Needle Insertion

Sensory Adapted Dental Environments to Enhance Oral Care for Children with Autism Spectrum Disorders: A Randomized Controlled Pilot Study

PubMed Central

Cermak, Sharon A.; Stein Duker, Leah I.; Williams, Marian E.; Dawson, Michael E.; Lane, Christianne J.; Polido, José C.

2015-01-01

This pilot and feasibility study examined the impact of a sensory adapted dental environment (SADE) to reduce distress, sensory discomfort, and perception of pain during oral prophylaxis for children with autism spectrum disorder (ASD). Participants were 44 children ages 6-12 (n=22 typical, n=22 ASD). In an experimental crossover design, each participant underwent two professional dental cleanings, one in a regular dental environment (RDE) and one in a SADE, administered in a randomized and counterbalanced order three to four months apart. Outcomes included measures of physiological anxiety, behavioral distress, pain intensity, and sensory discomfort. Both groups exhibited decreased physiological anxiety and reported lower pain and sensory discomfort in the SADE condition compared to RDE, indicating a beneficial effect of the SADE. PMID:25931290

Improving Language Comprehension in Preschool Children with Language Difficulties: A Cluster Randomized Trial

ERIC Educational Resources Information Center

Hagen, Åste M.; Melby-Lervåg, Monica; Lervåg, Arne

2017-01-01

Background: Children with language comprehension difficulties are at risk of educational and social problems, which in turn impede employment prospects in adulthood. However, few randomized trials have examined how such problems can be ameliorated during the preschool years. Methods: We conducted a cluster randomized trial in 148 preschool…

A pilot randomized, controlled trial of an active video game physical activity intervention.

PubMed

Peng, Wei; Pfeiffer, Karin A; Winn, Brian; Lin, Jih-Hsuan; Suton, Darijan

2015-12-01

Active video games (AVGs) transform the sedentary screen time of video gaming into active screen time and have great potential to serve as a "gateway" tool to a more active lifestyle for the least active individuals. This pilot randomized trial was conducted to explore the potential of theory-guided active video games in increasing moderate-to-vigorous physical activity (MVPA) among young adults. In this pilot 4-week intervention, participants were randomly assigned to 1 of the following groups: an AVG group with all the self determination theory (SDT)-based game features turned off, an AVG group with all the SDT-based game features turned on, a passive gameplay group with all the SDT-based game features turned on, and a control group. Physical activity was measured using ActiGraph GT3X accelerometers. Other outcomes included attendance and perceived need satisfaction of autonomy, competence and relatedness. It was found that playing the self-determination theory supported AVG resulted in greater MVPA compared with the control group immediately postintervention. The AVG with the theory-supported features also resulted in greater attendance and psychological need satisfaction than the non-theory-supported one. An AVG designed with motivation theory informed features positively impacted attendance and MVPA immediately postintervention, suggesting that including AVG features guided with motivation theory may be a method of addressing common problems with adherence and increasing effectiveness of active gaming. (PsycINFO Database Record (c) 2015 APA, all rights reserved).

A Youth-Led, Social Marketing Intervention Run by Adolescents to Encourage Healthy Lifestyles among Younger School Peers (EYTO-Kids Project): A Protocol for Pilot Cluster Randomized Controlled Trial (Spain)

PubMed Central

Aceves-Martins, Magaly; Papell-Garcia, Ignasi; Arola, Lluís; Giralt, Montse; Solà, Rosa

2017-01-01

Introduction: The EYTO-kids (European Youth Tackling Obesity in Adolescents and Children) study aims to increase fruit and/or vegetable consumption and physical activity, decrease sedentary lifestyles, and reduce the intake of sugary drinks and fast food using an innovative methodology based on social marketing and youth involvement. Methods: This study is a pilot school-based cluster randomized controlled 10-month intervention spanning two academic years (2015–2016 and 2016–2017), with eight primary schools and three high schools randomized into and designated the control group and eight primary schools and four high schools designated the intervention group in Reus, Spain. At least 301 younger school peers per group should be included. At the intervention high schools, the adolescent creators (ACs) receive an initial 16-h training session. In total, 26–32 high school ACs (12–14 years) from the four high schools will design and implement four health-promotion activities (1 h/each) for their younger (8–10 years), primary school peers. The control group will not receive any intervention. The outcomes (fruit, vegetable, fast food and sugary drink consumption; physical activity; and sedentary behaviors) of the control and intervention groups will be measured pre- and post-intervention. Conclusion: This study describes a protocol for pilot, peer-led, social marketing and youth-involved intervention, where adolescents design and implement activities for their younger peers to promote healthy lifestyles.

Using pilot data to size a two-arm randomized trial to find a nearly optimal personalized treatment strategy.

PubMed

Laber, Eric B; Zhao, Ying-Qi; Regh, Todd; Davidian, Marie; Tsiatis, Anastasios; Stanford, Joseph B; Zeng, Donglin; Song, Rui; Kosorok, Michael R

2016-04-15

A personalized treatment strategy formalizes evidence-based treatment selection by mapping patient information to a recommended treatment. Personalized treatment strategies can produce better patient outcomes while reducing cost and treatment burden. Thus, among clinical and intervention scientists, there is a growing interest in conducting randomized clinical trials when one of the primary aims is estimation of a personalized treatment strategy. However, at present, there are no appropriate sample size formulae to assist in the design of such a trial. Furthermore, because the sampling distribution of the estimated outcome under an estimated optimal treatment strategy can be highly sensitive to small perturbations in the underlying generative model, sample size calculations based on standard (uncorrected) asymptotic approximations or computer simulations may not be reliable. We offer a simple and robust method for powering a single stage, two-armed randomized clinical trial when the primary aim is estimating the optimal single stage personalized treatment strategy. The proposed method is based on inverting a plugin projection confidence interval and is thereby regular and robust to small perturbations of the underlying generative model. The proposed method requires elicitation of two clinically meaningful parameters from clinical scientists and uses data from a small pilot study to estimate nuisance parameters, which are not easily elicited. The method performs well in simulated experiments and is illustrated using data from a pilot study of time to conception and fertility awareness. Copyright © 2015 John Wiley & Sons, Ltd.

Design of the Blood Pressure Goals in Dialysis pilot study.

PubMed

Gul, Ambreen; Miskulin, Dana; Gassman, Jennifer; Harford, Antonia; Horowitz, Bruce; Chen, Joline; Paine, Susan; Bedrick, Edward; Kusek, John W; Unruh, Mark; Zager, Philip

2014-02-01

Cardiovascular disease (CVD) is markedly increased among hemodialysis (HD) patients. Optimizing blood pressure (BP) among HD patients may present an important opportunity to reduce the disparity in CVD rates between HD patients and the general population. The optimal target predialysis systolic BP (SBP) among HD patients is unknown. Current international guidelines, calling for a predialysis SBP < 140 mm Hg, are based on the opinion and extrapolation from the general population. Existing randomized controlled trials (RCTs) were small and did not include prespecified BP targets. The authors described the design of the Blood Pressure in Dialysis (BID) Study, a pilot, multicenter RCT where HD patients are randomized to either a target-standardized predialysis SBP of 110 to 140 mm Hg or 155 to 165 mm Hg. This is the first study to randomize HD patients to 2 different SBP targets. Primary outcomes are feasibility and safety. Feasibility parameters include recruitment and retention rates, adherence with prescribed BP measurements and achievement and maintenance of selected BP targets. Safety parameters include rates of hypotension and other adverse and serious adverse events. The authors obtained preliminary data on changes in left ventricular mass, aortic pulse wave velocity, vascular access thromboses and health-related quality of life across study arms, which may be the secondary outcomes in the full-scale study. The data acquired in the pilot RCT will determine the feasibility and safety and inform the design of a full-scale trial, powered for hard outcomes, which may require 2000 participants.

Home-based neurologic music therapy for arm hemiparesis following stroke: results from a pilot, feasibility randomized controlled trial.

PubMed

Street, Alexander J; Magee, Wendy L; Bateman, Andrew; Parker, Michael; Odell-Miller, Helen; Fachner, Jorg

2018-01-01

To assess the feasibility of a randomized controlled trial to evaluate music therapy as a home-based intervention for arm hemiparesis in stroke. A pilot feasibility randomized controlled trial, with cross-over design. Randomization by statistician using computer-generated, random numbers concealed in opaque envelopes. Participants' homes across Cambridgeshire, UK. Eleven people with stroke and arm hemiparesis, 3-60 months post stroke, following discharge from community rehabilitation. Each participant engaged in therapeutic instrumental music performance in 12 individual clinical contacts, twice weekly for six weeks. Feasibility was estimated by recruitment from three community stroke teams over a 12-month period, attrition rates, completion of treatment and successful data collection. Structured interviews were conducted pre and post intervention to establish participant tolerance and preference. Action Research Arm Test and Nine-hole Peg Test data were collected at weeks 1, 6, 9, 15 and 18, pre and post intervention by a blinded assessor. A total of 11 of 14 invited participants were recruited (intervention n = 6, waitlist n = 5). In total, 10 completed treatment and data collection. It cannot be concluded whether a larger trial would be feasible due to unavailable data regarding a number of eligible patients screened. Adherence to treatment, retention and interview responses might suggest that the intervention was motivating for participants. ClinicalTrials.gov identifier NCT 02310438.

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.

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.

Intraoperative Low-frequency Electroacupuncture under General Anesthesia Improves Postoperative Recovery in a Randomized Trial.

PubMed

Grech, Dennis; Li, Zhifeng; Morcillo, Patrick; Kalyoussef, Evelyne; Kim, David D; Bekker, Alex; Ulloa, Luis

2016-10-01

Neuronal stimulation improves physiological responses to infection and trauma, but the clinical potential of this strategy is unknown. We hypothesized that transdermal neural stimulation through low-frequency electroacupuncture might control the immune responses to surgical trauma and expedite the postoperative recovery. However, the efficiency of electroacupuncture is questioned due to the placebo effect. Here, electroacupuncture was performed on anesthetized patients to avoid any placebo. This is a prospective double-blinded pilot trial to determine whether intraoperative electroacupuncture on anesthetized patients improves postoperative recovery. Patients with electroacupuncture required 60% less postoperative analgesic, even they had pain scores similar to those in the control patients. Electroacupuncture prevented postoperative hyperglycemia and attenuated serum adrenocorticotropic hormone in the older and heavier group of patients. From an immunological perspective, electroacupuncture did not affect the protective immune responses to surgical trauma, including the induction of interleukin-6 and interleukin-10. The most significant immunological effect of electroacupuncture was enhancing transforming growth factor-β1 production during surgery in the older and lighter group of patients. These results suggest that intraoperative electroacupuncture on anesthetized patients can reduce postoperative use of analgesics and improve immune and stress responses to surgery. Copyright © 2016. Published by Elsevier B.V.

Effect of amiodarone therapy on mortality in patients with left ventricular dysfunction and asymptomatic complex ventricular arrhythmias: Argentine Pilot Study of Sudden Death and Amiodarone (EPAMSA).

PubMed

Garguichevich, J J; Ramos, J L; Gambarte, A; Gentile, A; Hauad, S; Scapin, O; Sirena, J; Tibaldi, M; Toplikar, J

1995-09-01

The efficiency of prophylactic antiarrhythmic treatment with amiodarone in reducing 1-year mortality in patients with reduced left ventricular ejection fraction ( < 35%) and asymptomatic ventricular arrhythmias (Lown classes 2 and 4) was investigated in a prospective, multicenter, randomized, controlled study. Among 127 patients who entered the study, 61 were assigned to no antiarrhythmic therapy (control group [CG] and 66 to amiodarone treatment (amiodarone group [AG]). Amiodarone was administered at a dosage of 800 mg/day for 2 weeks followed by 400 mg/day thereafter. A 12-month follow-up was completed for 106 patients (57 in the AG and 49 in the CG). Amiodarone reduced the overall mortality rate, which was 10.5% in the AG versus 28.6% in the CG (odds ratio [OR] 0.29; 95% confidence interval [CI] 0.10 to 0.84; log-rank test 0.02) and sudden death rate, which was 7.0% in the AG versus 20.4% in the CG (OR 0.29; 95% CI 0.08 to 1.00; log-rank test 0.04). Side effects were rare, and in only three patients did amiodarone treatment have to be discontinued.

Selective mutism: follow-up study 1 year after end of treatment.

PubMed

Oerbeck, Beate; Stein, Murray B; Pripp, Are H; Kristensen, Hanne

2015-07-01

Cognitive behavioral therapy (CBT) is generally considered the recommended approach for selective mutism (SM). Prospective follow-up studies of treated SM and predictors of outcome are scarce. We have developed a CBT home and school-based intervention for children with SM previously found to increase speech in a pilot efficacy study and in a randomized controlled treatment study. In the present report we provide outcome data 1 year after having completed the 6-month course of CBT for 24 children with SM, aged 3-9 years (mean age 6.5 years, 16 girls). Primary outcome measures were the teacher rated School Speech Questionnaire (SSQ) and diagnostic status. At follow-up, no significant decline was found on the SSQ scores. Age and severity of SM had a significant effect upon outcome, as measured by the SSQ. Eight children still fulfilled diagnostic criteria for SM, four were in remission, and 12 children were without diagnosis. Younger children improved more, as 78% of the children aged 3-5 years did not have SM, compared with 33% of children aged 6-9 years. Treatment gain was upheld at follow-up. Greater improvement in the younger children highlights the importance of an early intervention.

Mifepristone (RU 486) induces embryo expulsion in first trimester non-developing pregnancies: a prospective randomized trial.

PubMed

Lelaidier, C; Baton-Saint-Mleux, C; Fernandez, H; Bourget, P; Frydman, R

1993-03-01

This study was designed to investigate the use of oral mifepristone (RU 486) for the induction of natural expulsion of concepti in women with spontaneously interrupted pregnancy in the first trimester. It consisted of a double-blind placebo-controlled study of mifepristone (600 mg) against placebo. A total of 46 women consulting for interrupted pregnancy were diagnosed at ultrasound with no clinical sign of miscarriage. Measurements were made of the occurrence of natural expulsion, the frequency of complete expulsion, the need for subsequent surgical evacuation, analgesia and the need for transfusion. Natural expulsion occurred within 5 days in 82% of patients receiving mifepristone treatment versus 8% of placebo-treated patients (P < 0.001). All patients experienced bleeding after RU 486 and two needed emergency aspiration for haemorrhagic expulsion. The treatment failed in four patients, who underwent evacuation under local anaesthesia. In the control group, 19 patients underwent evacuation under local (n = 10) or general (n = 9) anaesthesia. It was concluded that a standard oral pilot dose of 600 mg of mifepristone induces natural expulsion in 82% of women with non-developing first trimester intrauterine pregnancies.

Intra-amniotic instillation of surfactants for the prevention of neonatal respiratory distress syndrome following preterm delivery.

PubMed

Agarwal, Nutan; Bathwal, Shikha; Kriplani, Alka; Deorari, Ashok; Bhatla, Neerja

2016-11-01

To assess the efficacy of intra-amniotic administration of surfactants in reducing the incidence and severity of respiratory distress syndrome (RDS), and the need for postnatal endotracheal surfactant during preterm delivery. A prospective pilot study enrolled pregnant women at 28-34 weeks of pregnancy between July 1, 2013 and December 31, 2014 who were randomly assigned in a 1:1 ratio to a control group or to receive intra-amniotic surfactant (3mL) administered under ultrasonography guidance within 2-8 hours of expected delivery. The primary outcomes, the incidence and severity of RDS, and the need for postnatal surfactants, were analyzed on an intention-to-treat basis. The study enrolled 20 patients to each group. The incidence of RDS did not differ between the two groups (P=0.110). Severe RDS was more common in the control group (P=0.018) and postnatal surfactants were required more frequently in the control group (P=0.02). Intra-amniotic administration of surfactants reduced RDS severity and the need for postpartum endotracheal surfactants. Clinical Trials Registry India: CTRI/2015/12/006399. Copyright © 2016 International Federation of Gynecology and Obstetrics. Published by Elsevier Ireland Ltd. All rights reserved.

Rationale, design and pilot feasibility results of a smartphone-assisted, mindfulness-based intervention for smokers with mood disorders: Project mSMART MIND.

PubMed

Minami, Haruka; Brinkman, Hannah R; Nahvi, Shadi; Arnsten, Julia H; Rivera-Mindt, Monica; Wetter, David W; Bloom, Erika Litvin; Price, Lawrence H; Vieira, Carlos; Donnelly, Remington; McClain, Lauren M; Kennedy, Katherine A; D'Aquila, Erica; Fine, Micki; McCarthy, Danielle E; Graham Thomas, J; Hecht, Jacki; Brown, Richard A

2018-03-01

Although individuals with psychiatric disorders are disproportionately affected by cigarette smoking, few outpatient mental health treatment facilities offer smoking cessation services. In this paper, we describe the development of a smartphone-assisted mindfulness smoking cessation intervention with contingency management (SMI-CM), as well as the design and methods of an ongoing pilot randomized controlled trial (RCT) targeting smokers receiving outpatient psychiatric treatment. We also report the results of an open-label pilot feasibility study. In phase 1, we developed and pilot-tested SMI-CM, which includes a smartphone intervention app that prompts participants to practice mindfulness, complete ecological momentary assessment (EMA) reports 5 times per day, and submit carbon monoxide (CO) videos twice per day. Participants earned incentives if submitted videos showed CO≤6ppm. In phase 2, smokers receiving outpatient treatment for mood disorders are randomized to receive SMI-CM or enhanced standard treatment plus non-contingent CM (EST). The results from the pilot feasibility study (N=8) showed that participants practiced mindfulness an average of 3.4times/day (≥3min), completed 72.3% of prompted EMA reports, and submitted 68.0% of requested CO videos. Participants reported that the program was helpful overall (M=4.85/5) and that daily mindfulness practice was helpful for both managing mood and quitting smoking (Ms=4.50/5). The results from the feasibility study indicated high levels of acceptability and satisfaction with SMI-CM. The ongoing RCT will allow evaluation of the efficacy and mechanisms of action underlying SMI-CM for improving cessation rates among smokers with mood disorders. Copyright © 2017 Elsevier Inc. All rights reserved.

Progressive Staging of Pilot Studies to Improve Phase III Trials for Motor Interventions

PubMed Central

Dobkin, Bruce H.

2014-01-01

Based on the suboptimal research pathways that finally led to multicenter randomized clinical trials (MRCTs) of treadmill training with partial body weight support and of robotic assistive devices, strategically planned successive stages are proposed for pilot studies of novel rehabilitation interventions Stage 1, consideration-of-concept studies, drawn from animal experiments, theories, and observations, delineate the experimental intervention in a small convenience sample of participants, so the results must be interpreted with caution. Stage 2, development-of-concept pilots, should optimize the components of the intervention, settle on most appropriate outcome measures, and examine dose-response effects. A well-designed study that reveals no efficacy should be published to counterweight the confirmation bias of positive trials. Stage 3, demonstration-of-concept pilots, can build out from what has been learned to test at least 15 participants in each arm, using random assignment and blinded outcome measures. A control group should receive an active practice intervention aimed at the same primary outcome. A third arm could receive a substantially larger dose of the experimental therapy or a combinational intervention. If only 1 site performed this trial, a different investigative group should aim to reproduce positive outcomes based on the optimal dose of motor training. Stage 3 studies ought to suggest an effect size of 0.4 or higher, so that approximately 50 participants in each arm will be the number required to test for efficacy in a stage 4, proof-of-concept MRCT. By developing a consensus around acceptable and necessary practices for each stage, similar to CONSORT recommendations for the publication of phase III clinical trials, better quality pilot studies may move quickly into better designed and more successful MRCTs of experimental interventions. PMID:19240197

Provider training to screen and initiate evidence-based pediatric obesity treatment in routine practice settings: A randomized pilot trial

PubMed Central

Kolko, Rachel P.; Kass, Andrea E.; Hayes, Jacqueline F.; Levine, Michele D.; Garbutt, Jane M.; Proctor, Enola K.; Wilfley, Denise E.

2016-01-01

Introduction This randomized pilot trial evaluated two training modalities for first-line, evidence-based pediatric obesity services (screening and goal-setting) among nursing students. Method Participants (N=63) were randomized to Live Interactive Training (Live) or Web-facilitated Self-study Training (Web). Pre-training, post-training, and one-month follow-up assessments evaluated training feasibility, acceptability, and impact (knowledge, and skill via simulation). Moderator (previous experience) and predictor (content engagement) analyses were conducted. Results Nearly-all (98%) participants completed assessments. Both trainings were acceptable, with higher ratings for Live and participants with previous experience (p’s<.05). Knowledge and skill improved from pre-training to post-training and follow-up in both conditions (p’s<.001). Live demonstrated greater content engagement (p’s<.01). Conclusions The training package was feasible, acceptable, and efficacious among nursing students. Given that Live had higher acceptability and engagement, and online training offers greater scalability, integrating interactive Live components within Web-based training may optimize outcomes, which may enhance practitioners’ delivery of pediatric obesity services. PMID:26873293

Olive Oil, Sunflower Oil or no Oil for Baby Dry Skin or Massage: A Pilot, Assessor-blinded, Randomized Controlled Trial (the Oil in Baby SkincaRE [OBSeRvE] Study).

PubMed

Cooke, Alison; Cork, Michael J; Victor, Suresh; Campbell, Malcolm; Danby, Simon; Chittock, John; Lavender, Tina

2016-03-01

Topical oils on baby skin may contribute to development of childhood atopic eczema. A pilot, assessor-blinded, randomized controlled trial assessed feasibility of a definitive trial investigating their impact in neonates. One-hundred and fifteen healthy, full-term neonates were randomly assigned to olive oil, sunflower oil or no oil, twice daily for 4 weeks, stratified by family history of atopic eczema. We measured spectral profile of lipid lamellae, trans-epidermal water loss (TEWL), stratum corneum hydration and pH and recorded clinical observations, at baseline, and 4 weeks post-birth. Recruitment was challenging (recruitment 11.1%; retention 80%), protocol adherence reasonable (79-100%). Both oil groups had significantly improved hydration but significantly less improvement in lipid lamellae structure compared to the no oil group. There were no significant differences in TEWL, pH or erythema/skin scores. The study was not powered for clinical significance, but until further research is conducted, caution should be exercised when recommending oils for neonatal skin.

A pilot randomized, controlled trial of the effectiveness of a psychoeducational intervention on family caregivers of patients with advanced cancer.

PubMed

Leow, Mabel; Chan, Sally; Chan, Moon

2015-03-01

To evaluate the effectiveness of a psychoeducational intervention, the Caring for the Caregiver Programme (CCP).
 A pilot randomized, controlled trial, two-group pretest, and repeated post-tests.
 Four home hospice organizations and an outpatient clinic in Singapore.
 80 caregivers were randomized into experimental and standard care groups.
 Outcomes were measured at baseline, week 4, and week 8 after the intervention. The standard care group received routine home hospice care, and the intervention group received the CCP in addition to routine care.
 Quality of life (QOL), social support, stress and depression, self-efficacy in self-care, closeness with the patient, rewards, and knowledge.
 Compared to the standard care group, the intervention group reported significantly higher QOL, social support satisfaction and number of supported people, closeness with the patient, self-efficacy in self-care, rewards of caregiving, and knowledge, and lower stress and depression. 
 The CCP had positive effects on family caregivers of patients with advanced cancer. 
 A psychoeducational intervention potentially could help caregivers cope with the demands of caregiving. 


Mirror therapy for distal radial fractures: A pilot randomized controlled study.

PubMed

Bayon-Calatayud, Manuel; Benavente-Valdepeñas, Ana Maria; Del Prado Vazquez-Muñoz, Maria

2016-10-12

To investigate the efficacy of mirror therapy in reducing pain and disability in patients with distal radial fractures. Pilot randomized controlled study. Twenty-two patients with closed distal radial fracture. Patients were randomly assigned to experimental (= 11) or control (= 11) groups. Researchers were blinded to group allocation. Both groups received conventional physiotherapy. In addition, the experimental group had 15 sessions of mirror therapy (a daily session, 30 min). The control group received the same amount of conventional occupational therapy. Assessment was made from baseline to post-treatment. Pain was measured on a visual analogue scale (VAS). Active wrist extension and Quick-DASH (Disabilities of Arm, Shoulder and Hand) were used to assess functional recovery. Pain, disability, and range of motion improved for both groups after intervention. No significant post-treatment differences were found between groups in Quick-DASH (= 0.409), active wrist extension (= 0.191) and VAS scores (= 0.807). There was no significant difference in active wrist extension between groups. Mirror therapy was not superior to conventional occupational therapy in reducing pain and disability.

Low-dose lisinopril in normotensive men with idiopathic oligospermia and infertility: a 5-year randomized, controlled, crossover pilot study.

PubMed

Mbah, A U; Ndukwu, G O; Ghasi, S I; Shu, E N; Ozoemena, F N; Mbah, J O; Onodugo, O D; Ejim, E C; Eze, M I; Nkwo, P O; Okonkwo, P O

2012-04-01

The outcomes of drug treatment for male infertility remain conjectural, with controversial study results. Our pilot study employed a randomized, placebo-controlled, crossover methodology with intention-to-treat analysis. Thirty-three men with idiopathic oligospermia were randomized to start either daily oral lisinopril 2.5 mg (n = 17) or daily oral placebo (n = 16). Lisinopril was found to cause a normalization of seminal parameters in 53.6% of the participants. Although the mean ejaculate volume was unchanged (P ≥ 0.093), the total sperm cell count and the percentage of motile sperm cells increased (P ≤ 0.03 and P < 0.001, respectively), whereas the percentage of sperm cells with abnormal morphology decreased (P ≤ 0.04). The pregnancy rate was 48.5%, and there was no serious adverse drug event. It is concluded, albeit cautiously, that prolonged treatment with 2.5 mg/day of oral lisinopril may be well tolerated in normotensive men with idiopathic oligospermia, may improve sperm quantity and quality, and may enhance fertility in approximately half of those treated.

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.

Pilot Trial of a Parenting and Self-Care Intervention for HIV-Positive Mothers: The IMAGE Program

PubMed Central

Murphy, Debra A.; Armistead, Lisa; Payne, Diana L.; Marelich, William D.; Herbeck, Diane M.

2016-01-01

A pilot study was conducted to assess the effects of the IMAGE pilot intervention (Improving Mothers’ parenting Abilities, Growth, and Effectiveness) on mothers living with HIV (MLH). Based on Fisher and Fisher's IMB model (1992), the intervention focused on self-care and parenting behavior skills of MLH that affect maternal, child, and family outcomes. A randomized pretest-posttest two-group design with repeated assessments was used. MLH (n = 62) and their children ages 6 - 14 (n = 62; total N = 124) were recruited for the trial and randomized to the theory-based skills training condition or a standard care control condition. Assessments were conducted at baseline with follow-ups at 3, 6, and 12 months. Maternal, child, and family outcomes were assessed. Results show significant effects of the intervention for improving parenting practices for mothers. The intervention also improved family outcomes, and showed improvements in the parent-child relationship. IMAGE had a positive impact on parenting behaviors, and on maternal, child, and family outcomes. Given MLH can be challenged by their illness and also live in under-resourced environments, IMAGE may be viewed as a viable way to improve quality of life and family outcomes. PMID:27377577

Acceptance and Commitment Therapy for Inpatients with Psychosis (the REACH Study): Protocol for Treatment Development and Pilot Testing

PubMed Central

Gaudiano, Brandon A.; Davis, Carter H.; Epstein-Lubow, Gary; Johnson, Jennifer E.; Mueser, Kim T.; Miller, Ivan W.

2017-01-01

Patients with schizophrenia-spectrum disorders frequently require treatment at inpatient hospitals during periods of acute illness for crisis management and stabilization. Acceptance and Commitment Therapy (ACT), a “third wave” cognitive-behavioral intervention that employs innovative mindfulness-based strategies, has shown initial efficacy in randomized controlled trials for improving acute and post-discharge outcomes in patients with psychosis when studied in acute-care psychiatric hospitals in the U.S. However, the intervention has not been widely adopted in its current form because of its use of an individual-only format and delivery by doctoral-level research therapists with extensive prior experience using ACT. The aim of the Researching the Effectiveness of Acceptance-based Coping during Hospitalization (REACH) Study is to adapt a promising acute-care psychosocial treatment for inpatients with psychosis, and to pilot test its effectiveness in a routine inpatient setting. More specifically, we describe our plans to: (a) further develop and refine the treatment and training protocols, (b) conduct an open trial and make further modifications based on the experience gained, and (c) conduct a pilot randomized controlled trial in preparation for a future fully-powered clinical trial testing the effectiveness of ACT. PMID:28475123

A pilot study of the efficacy of a computerized executive functioning remediation training with game elements for children with ADHD in an outpatient setting: outcome on parent- and teacher-rated executive functioning and ADHD behavior.

PubMed

van der Oord, S; Ponsioen, A J G B; Geurts, H M; Ten Brink, E L; Prins, P J M

2014-11-01

This pilot study tested the short- and long-term efficacy (9 weeks follow-up) of an executive functioning (EF) remediation training with game elements for children with ADHD in an outpatient clinical setting, using a randomized controlled wait-list design. Furthermore, in a subsample, that is, those treated with methylphenidate, additive effects of the EF training were assessed. A total of 40 children (aged 8-12 years) were randomized to the EF training or wait-list. The training consisted of a 25-session training of inhibition, cognitive flexibility, and working memory. Treatment outcome was assessed by parent- and teacher-rated EF, ADHD, oppositional deviant disorder, and conduct disorder symptoms. Children in the EF training showed significantly more improvement than those in the wait-list condition on parent-rated EF and ADHD behavior in the total sample and in the subsample treated with methylphenidate. Effects were maintained at follow-up. This pilot study shows promising evidence for the efficacy of an EF training with game elements. © 2012 SAGE Publications.

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.

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.

Pilot Study on the Applicability of Variance Reduction Techniques to the Simulation of a Stochastic Combat Model

DTIC Science & Technology

1987-09-01

inverse transform method to obtain unit-mean exponential random variables, where Vi is the jth random number in the sequence of a stream of uniform random...numbers. The inverse transform method is discussed in the simulation textbooks listed in the reference section of this thesis. X(b,c,d) = - P(b,c,d...Defender ,C * P(b,c,d) We again use the inverse transform method to obtain the conditions for an interim event to occur and to induce the change in

Eight weeks of exercise training increases aerobic capacity and muscle mass and reduces fatigue in patients with cirrhosis.

PubMed

Zenith, Laura; Meena, Neha; Ramadi, Ailar; Yavari, Milad; Harvey, Andrea; Carbonneau, Michelle; Ma, Mang; Abraldes, Juan G; Paterson, Ian; Haykowsky, Mark J; Tandon, Puneeta

2014-11-01

Patients with cirrhosis have reduced exercise tolerance, measured objectively as decreased peak exercise oxygen uptake (peak VO2). Reduced peak VO2 is associated with decreased survival time. The effect of aerobic exercise training on peak VO2 has not been well studied in patients with cirrhosis. We evaluated the safety and efficacy of 8 weeks of supervised exercise on peak VO2, quadriceps muscle thickness, and quality of life. In a prospective pilot study, stable patients (79% male, 57.6 ± 6.7 years old) with Child-Pugh class A or B cirrhosis (mean Model for End-Stage Liver Disease score, 10 ± 2.2) were randomly assigned to groups that received exercise training (n = 9) or usual care (controls, n = 10) at the University of Alberta Hospital in Canada from February through June 2013. Supervised exercise was performed on a cycle ergometer 3 days/week for 8 weeks at 60%-80% of baseline peak VO2. Peak VO2, quadriceps muscle thickness (measured by ultrasound), thigh circumference, answers from Chronic Liver Disease Questionnaires, EQ-visual analogue scales, 6-minute walk distance, and Model for End-Stage Liver Disease scores were evaluated at baseline and at week 8. Analysis of covariance was used to compare variables. At week 8, peak VO2 was 5.3 mL/kg/min higher in the exercise group compared with controls (95% confidence interval, 2.9-7.8; P = .001). Thigh circumference (P = .001), thigh muscle thickness (P = .01), and EQ-visual analogue scale determined self-perceived health status (P = .01) was also significantly higher in the exercise group compared with controls at week 8; fatigue subscores of the Chronic Liver Disease Questionnaires were lower in the exercise group compared with controls (P = .01). No adverse events occurred during cardiopulmonary exercise testing or training. In a controlled prospective pilot trial, 8 weeks of supervised aerobic exercise training increased peak VO2 and muscle mass and reduced fatigue in patients with cirrhosis. No relevant adverse effects were observed. Larger trials are needed to evaluate the effects of exercise in patients with cirrhosis. ClinicalTrials.gov number: NCT01799785. Copyright © 2014 AGA Institute. Published by Elsevier Inc. All rights reserved.